summary of chapter 3 in a research proposal

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HOW TO WRITE CHAPTER THREE OF YOUR RESEARCH PROJECT (RESEARCH METHODOLOGY) | ResearchWap Blog

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How To Write Chapter Three Of Your Research Project (Research Methodology)

Methodology In Research Paper

Chapter three of the research project or the research methodology is another significant part of the research project writing. In developing the chapter three of the research project, you state the purpose of research, research method you wish to adopt, the instruments to be used, where you will collect your data, types of data collection, and how you collected it.

This chapter explains the different methods to be used in the research project. Here you mention the procedures and strategies you will employ in the study such as research design, study design in research, research area (area of the study), the population of the study, etc.

You also tell the reader your research design methods, why you chose a particular method, method of analysis, how you planned to analyze your data. Your methodology should be written in a simple language such that other researchers can follow the method and arrive at the same conclusion or findings.

You can choose a survey design when you want to survey a particular location or behavior by administering instruments such as structured questionnaires, interviews, or experimental; if you intend manipulating some variables.

The purpose of chapter three (research methodology) is to give an experienced investigator enough information to replicate the study. Some supervisors do not understand this and require students to write what is in effect, a textbook.

A research design is used to structure the research and to show how all of the major parts of the research project, including the sample, measures, and methods of assignment, work together to address the central research questions in the study. The chapter three should begin with a paragraph reiterating the purpose of research.

It is very important that before choosing design methods, try and ask yourself the following questions:

Will I generate enough information that will help me to solve the research problem by adopting this method?

Method vs Methodology

I think the most appropriate in methods versus methodology is to think in terms of their inter-connectedness and relationship between both. You should not beging thinking so much about research methods without thinking of developing a research methodology.

Metodologia or methodology is the consideration of your research objectives and the most effective method  and approach to meet those objectives. That is to say that methodology in research paper is the first step in planning a research project work. 

Design Methodology: Methodological Approach                

Example of methodology in research paper, you are attempting to identify the influence of personality on a road accident, you may wish to look at different personality types, you may also look at accident records from the FRSC, you may also wish to look at the personality of drivers that are accident victims, once you adopt this method, you are already doing a survey, and that becomes your  metodologia or methodology .

Your methodology should aim to provide you with the information to allow you to come to some conclusions about the personalities that are susceptible to a road accident or those personality types that are likely to have a road accident. The following subjects may or may not be in the order required by a particular institution of higher education, but all of the subjects constitute a defensible in metodologia or methodology chapter.

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Methodology

A  methodology  is the rationale for the research approach, and the lens through which the analysis occurs. Said another way, a methodology describes the “general research strategy that outlines the way in which research is to be undertaken” The methodology should impact which method(s) for a research endeavor are selected in order to generate the compelling data.

Example Of Methodology In Research Paper :

• Phenomenology: describes the “lived experience” of a particular phenomenon
• Ethnography: explores the social world or culture, shared beliefs and behaviors
• Participatory: views the participants as active researchers
• Ethno methodology: examines how people use dialogue and body language to construct a world view
• Grounding theory*: assumes a blank slate and uses an inductive approach to develop a new theory

A  method  is simply the tool used to answer your research questions — how, in short, you will go about collecting your data.

Methods Section Of Research Paper Example :

• Contextual inquiry
• Usability study
• Diary study

If you are choosing among these, you might say “what method should I use?” and settle on one or more methods to answer your research question.

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Research Design Definition: WRITING A RESEARCH DESIGN

A qualitative study does not have variables. A scientific study has variables, which are sometimes mentioned in Chapter 1 and defined in more depth in Chapter 3. Spell out the independent and dependent, variables. An unfortunate trend in some institutions is to repeat the research questions and/or hypotheses in both Chapter 1 and Chapter 3. Sometimes an operational statement of the research hypotheses in the null form is given to set the stage for later statistical inferences. In a quantitative study, state the level of significance that will be used to accept or reject the hypotheses.

Pilot Study

In a quantitative study, a survey instrument that the researcher designed needs a pilot study to validate the effectiveness of the instrument, and the value of the questions to elicit the right information to answer the primary research questions in. In a scientific study, a pilot study may precede the main observation to correct any problems with the instrumentation or other elements in the data collection technique. Describe the pilot study as it relates to the research design, development of the instrument, data collection procedures, or characteristics of the sample.

Instruments

In a research study, the instrument used to collect data may be created by the researcher or based on an existing instrument. If the instrument is the researcher created, the process used to select the questions should be described and justified. If an existing instrument is used, the background of the instrument is described including who originated it, and what measures were used to validate it.

If a Likert scale is used, the scale should be described. If the study involves interviews, an interview protocol should be developed that will result in a consistent process of data collection across all interviews. Two types of questions are found in an interview protocol: the primary research questions, which are not asked of the participants, and the interview questions that are based on the primary research questions and are asked of the participants.

In a qualitative study, this is the section where most of the appendices are itemized, starting with letters of permission to conduct the study and letters of invitation to participate with the attached consent forms. Sample: this has to do with the number of your participants or subjects as the case may be. Analysis (how are you planning to analyze the results?)

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EFFECTIVE GUIDE AND METHODOLOGY SAMPLES

This chapter deals effectively with the research methods to be adopted in conducting the research, and it is organized under the following sub-headings:

• Research Design
• Area of Study

The population of the Study

• Sample and Sampling Techniques
• Instruments for Data Collection

The validity of the Instrument

Reliability of the Instrument

• Administration of the instruments
• Scoring the instruments

Method of Data Collection

Method of Data Analysis

Research Design:

This has to do with the structure of the research instrument to be used in collecting data. It could be in sections depending on different variables that form the construct for the entire topic of the research problems. A reliable instrument with a wrong research design will adversely affect the reliability and generalization of the research. The choice of design suitable for each research is determined by many factors among which are: kind of research, research hypothesis, the scope of the research, and the sensitive nature of the research.

Area of Study:

Research Area; this has to do with the geographical environment of the study area where the places are located, the historical background when necessary and commercial activities of that geographical area. For example, the area of the study is Ebonyi State University. At the creation of Ebonyi State in 1996, the Abakaliki campus of the then ESUT was upgraded to Ebonyi State University College by Edict no. 5 of Ebonyi State, 1998 still affiliated to ESUT with Prof. Fidelis Ogah, former ESUT Deputy Vice-Chancellor as the first Rector. In 1997, the Faculty of Applied and Natural Sciences with 8 departments was added to the fledging University, and later in 1998 when the ESUT Pre-Science Programme was relocated to Nsukka, the EBSUC Pre-Degree School commenced lectures in both Science and Arts in replacement of the former. This study focused on the students of the Business Education department in Ebonyi state university.

The population is regarded in research work as the type of people and the group of people under investigation. It has to be specific or specified. For example educational study teachers in Lagos state. Once the population is chosen, the next thing is to choose the samples from the population.

According to Uma (2007), the population is referred to as the totality of items or object which the researcher is interested in. It can also be the total number of people in an area of study. Hence, the population of this study comprised of all the students in the department of Business Education, Ebonyi State University which is made up of year one to four totaling 482. The actual number for the study was ascertained using Yaro-Yamane's formula which stated thus:

n   =        N

N is the Population

1 is constant

e is the error margin

Then, n   =         482

1+482(0.05)2

= 214.35 approximately 214

Sample and sampling technique:

It may not be possible to reach out to the number of people that form the entire population for the study to either interview, observe, or serve them with copies of the questionnaire. To be realistic, the sample should be up to 20% of the total population. Two sampling techniques are popular among all the sampling techniques. These are random and stratified random sampling techniques. (A). in Random Sampling, the writers select any specific number from a place like a school, village, etc. (B). In Stratified Random Sampling, one has to indicate a specific number from a stratum which could be a group of people according to age, qualification, etc. or different groups from different locations and different considerations attached.

Instruments for Data Collection:

This is a device or different devices used in collecting data. Example: interview, questionnaire, checklist, etc. instrument is prepared in sets or subsections, each set should be an entity thus asking questions about a particular variable to be tested after collecting data. The type of instrument used will determine the responses expected. All questions should be well set so as to determine the reliability of the instrument.

This has to do with different measures in order to determine the validity and reliability of the research instrument. For example, presenting the drafted questionnaire to the supervisor for scrutiny. Giving the questionnaire to the supervisor for useful comments and corrections would help to validate the instrument.

The test-retest reliability method is one of the simplest ways of testing the stability and reliability of an instrument over time. The test-retest approach was adopted by the researcher in establishing the reliability of the instrument. In doing this 25 copies of the questionnaire were administered on twenty-five selected respondents. After two weeks another 25 copies of the same questionnaire were re-administered on the same group. Their responses on the two occasions were correlated using Parsons Product Moment Correlation. A co-efficient of 0.81 was gotten and this was high enough to consider the instrument reliable.

Administration of the instruments:

Here, the writer states whether he or she administers the test personally or through an assistant. He also indicates the rate of return of the copies of the questionnaire administered.

Scoring the instruments:

Here items on the questionnaire or any other device used must be assigned numerical values. For example, 4 points to strongly agree, 3 points to agree, 2 points to disagree, and 1 point to strongly disagree.

Table of Analysis

The researcher collected data using the questionnaire. Copies of the questionnaire were administered by the researcher on the respondents. All the respondents were expected to give maximum co-operation, as the information on the questionnaire is all on things that revolve around their study. Hence, enough time was taken to explain how to tick or indicate their opinion on the items stated in the research questionnaire.

In this study, the mean was used to analyze the data collected. A four (4) point Likert scale was used to analyze each of the questionnaire items.

The weighing was as follows:

VGE—————- Very Great Extent (4 points)

GE—————– Great Extent (3 points)

LE—————– Little Extent (2 points)

VLE—————- Very Little Extent (1 point)

SA—————– Strongly Agree (4 points)

A——————- Agree (3 points)

D—————— Disagree (2 points)

SD—————- Strongly Disagree (1 point)

The mean of the scale will then be determined by summing up the points and dividing their number as follows with the formula:

Where; x= mean

f= frequency

X= Nominal value of the option

∑= summation

N= Total Number

Therefore, the mean of the scale is 2.5.

This means that any item statement with a mean of 2.50 and above is considered agreed by the respondents and any item statement below 2.5 is considered disagreed.

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How To Write Chapter 3 Of A PhD Thesis Proposal (A Detailed Guide)

The format of a PhD thesis proposal varies from one institution to another. In most cases, however, chapter 3 of the PhD thesis is the research methodology chapter.

This article discusses the main sections of the research methodology chapter and provides tips on how best to write it.

Introduction

Research design, population and sampling, random sampling, non-random sampling, data collection methods and tools, questionnaires, focus group discussions, observation, document review, ethical considerations, data analysis, limitations of the study, final thoughts on how to write chapter 3 of a phd thesis proposal.

The first section is a brief introduction to the chapter, which highlights what the chapter is about.

This section discusses the research design that the study will use. The research design should be guided by the research objectives and research questions the student wants to answer. The research design can be: quantitative, qualitative, or mixed-methods design.

In quantitative research, the study will collect, analyse and present numerical data in the form of statistics. The statistics can be descriptive, inferential, or a mix of both.

In qualitative research, the study collects, analyses and presents data that is in the form of words, opinions, or thoughts of the respondents. Its focus is on the lived-in experiences of the respondents with regard to the problem under investigation.

In mixed-methods research, the study uses a combination of quantitative and qualitative research methods. So some of the research questions render themselves to quantitative research, while others to qualitative research.

Each of these research designs has its pros and cons.

Population of study refers to the entire list of your subjects of interest. If the population is so small, the student can opt to include all the subjects in the study. However, if the population is large, it becomes difficult – both time-wise and resource-wise – to include all the subjects in the study.

A sample is a sub-set of the population of study from which data will be collected to enable the student understand the population.

An example of population vs. sample: Suppose a study aims at investigating the effects of COVID-19 pandemic on micro and small enterprises (MSEs) in Kenya. The population of the study will be all the MSEs in Kenya, which are thousands in number, distributed across the country. It will be impossible for the student to collect data from all those MSEs and therefore a sample will be necessary. The sample size the student decides to use will depend on whether the study is quantitative, qualitative or both. For quantitative studies, a large sample size is necessary, while for qualitative study, the sample size need not be large.

Sampling is the process by which a sample is drawn from a population. There are two categories of sampling techniques, namely: random and non-random sampling. The use of either depends on your research design.

In random sampling, the sample is selected randomly and each subject in the population has an equal chance of being selected for the sample.

The advantage of random sampling is that the results from the sample can be generalised to the population, especially if the sample size is sufficiently large.

Random sampling is used primarily for quantitative studies.

In non-random sampling, the sample is selected deliberately rather than randomly. As a result, the subjects do not have an equal chance of being selected for the sample.

It is also referred to as purposive sampling, meaning that the sample being selected have a specific purpose.

Non-random sampling is used primarily for qualitative sampling.

In this section, the student is expected to discuss in detail the type of data he will collect, that is, whether primary or secondary data (or both) and how he will go about collecting the data from the sample. The methods and tools used also depend on the research design. They include:

Questionnaires are mostly used to collect quantitative data.

Questionnaires are structured in nature and include closed-ended questions.

There are four main types of closed-ended questions used in questionnaires:

• for example: how many children do you have?
• for example: does your household have a radio? 1. Yes 2. No
• for example: what is your highest level of education? 1. No education 2. Primary education 3. Secondary education 4. Tertiary level
• for example: please rate your level of satisfaction with the water services board. 1. Very dissatisfied 2. Dissatisfied 3. Neutral 4. Satisfied 5. Very satisfied

There are two forms of questionnaaire delivery: facilitated questionnaires and self-administered questionnaires.

For facilitated questionnaires, the researcher administers the questionnaire while in self-administered questionnaires, the respondent fills in the questionnaire without the presence of the researcher.

Self-administered questionnaires can be delivered by hand, or mailed via the post office or through email. Facilitated questionnaires can be done either face-to-face or through telephone. Each of these options has its pros and cons.

Interviews are oral discussions between the researcher and the respondent.

Unlike questionnaires, interviews are semi-structured. The researcher uses an interview guide to guide the discussion. The interview guide has some questions that the researcher asks the respondent. However, subsequent questions and discussions are determined by the responses given by the respondent to previous questions.

The flow of interviews will therefore vary from one respondent to another depending on their personalities and openness to responding to the questions.

Whereas interviews are held with individuals, focus group discussions (FGDs) are held with a group of respondents who are key to the problem under investigation.

The participants for an FGD should be selected carefully to represent diverse subjects of the population under investigation.

In the example of the study on the effects of COVID-19 pandemic on micro and small enterprises in Kenya, the student can create a focus group that has the following members: a female-owned enterprise, a male-owned enterprise, a youth-owned enterprise, a family-run enterprise, a non-family-run enterprise, customers of the enterprises, and an employee of the Micro and Small Enterprises Authority (MSEA). Such a focus group would have rich discussions of the views of the different players in the industry.

Observation is also a method of data collection that is commonly used. There are two types of observation: participant observation and non-participant observation.

In participant observation, the researcher immerses himself into the environment of study. In the MSEs study, for example, the researcher would choose to work in one of the enterprises for a period of time where he would observe how the business performs on a day-to-day basis.

In non-participant observation, the researcher removes himself from the environment of study and instead observes from a distance. In the MSEs study, for example, the researcher would go somewhere close to an enterprise and observe how the business performs e.g. how many clients visit the business on a day-to-day basis.

Each observation type has its own pros and cons.

During observation, the researcher should use an observation checklist that guides him on what needs to be observed and the frequency of observation.

In this data collection methods, the student obtains relevant documents to his study and reviews them in-depth. For instance, in the MSEs, the student can review the MSEs Policy of Kenya, Strategic Plan of the Micro and Small Enterprises Authority etc. Such documents are useful in informing the researcher the current state of affairs of the problem under investigation.

This section highlights the ethical considerations that would be followed during the data collection process. The ethical considerations vary from study to study and include:

Consent: the researcher should seek informed consent from the respondent before the data collection begins. For instance, when administering the questionnaire or conducting interviews, the researcher should start by informing the respondent what the study is about, how the respondent was selected, and the benefits of the study and then seek permission to continue with the study. The consent can be in written or oral form.

Compensation for participation: while participating in the study should be voluntary, some research have allowance for monetary compensation. The respondents should be informed of any plans to compensate them but after they have participated in the study, not before.

Confidentiality: the researcher should assure the respondents that their responses will be kept confidential.

Dissemination of the study findings with the respondents: there should be a plan for the student to disseminate the results of the study with the participants, for instance, through validation workshops or written publications.

Additionally, most academic institutions require their students to obtain ethical clearance for their research from the relevant authorities. Students should check if this requirement applies to them and follow the necessary procedure.

In this section, the student should discuss how the data collected will be analysed. Data analysis methods and techniques vary depending on whether the data is quantitative or qualitative.

For quantitative research, the interest of data analysis is the numbers which can be obtained through descriptive statistics and inferential statistics.

Descriptive statistics is usually the first step in analysing quantitative data. There are three categories of descriptive statistics:

• Measures of frequency: frequency table or cross-tabulation table.
• Measures of central tendency: mean, median and mode.
• Measures of variability: range, standard deviation and variance.

Inferential analysis goes a step further and looks at whether the results from the sample can be generalised to the wider population. For studies that involve interventions, inferential analysis is used to check if the intervention has any impact on the population in which it was implemented.

Some inferential analysis techniques include:

• Checking for differences between groups: t-test, analysis of variance (ANOVA) and Chi-square test.
• Checking for correlation or causation between variables: linear regression, logistic regression (logit, probit, multinomial logit/probit models etc).

The choice of data analysis technique will depend on the type of data the student has. For instance, a dependent variable that is continuous will use a different analysis technique from a dependent variable that is categorical in nature. Additionally, the choice of the data analysis technique should be guided by the research questions. The results from the analysis should be able to provide answers to the research questions posed.

For qualitative research, data analysis involves analysing the content of the interviews and focus group discussions. The content can be in different forms such as interview recordings and hand-written notes.

The recordings should be transcribed first and the notes should be organised well before analysis can take place.

The analysis of qualitative data involves coding the data, indexing the data and framing the data to identify the themes that emerge from the data.

Besides discussing the data analysis techniques, the student should discuss the softwares that will be used for analysis. There are many softwares in the market that are used for quantitative (such as SPSS and STATA) and qualitative data (such as NVivo).

The last section in the research methodology chapter discusses the potential limitations of the study and how the limitations will be mitigated. An example of study limitation is low response rate of questionnaires, which can be mitigated through triangulation.

The limitations of the study will vary from one study to another and depend on the context within which the study is conducted.

This article provided a detailed guide on how to write the research methodology chapter of a PhD thesis proposal. The research methodology chapter is informed by the research problem and research questions specified in chapter 1 of the thesis proposal. Students should therefore think through carefully their research study from the beginning because what is in the introduction chapter informs the content in the remaining chapters of the proposal and final thesis.

Related posts

How To Write Chapter 1 Of A PhD Thesis Proposal (A Practical Guide)

How To Write Chapter 2 Of A PhD Thesis Proposal (A Beginner’s Guide)

Grace Njeri-Otieno

Grace Njeri-Otieno is a Kenyan, a wife, a mom, and currently a PhD student, among many other balls she juggles. She holds a Bachelors' and Masters' degrees in Economics and has more than 7 years' experience with an INGO. She was inspired to start this site so as to share the lessons learned throughout her PhD journey with other PhD students. Her vision for this site is "to become a go-to resource center for PhD students in all their spheres of learning."

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• How to Write a Research Proposal | Examples & Templates

How to Write a Research Proposal | Examples & Templates

Published on October 12, 2022 by Shona McCombes and Tegan George. Revised on November 21, 2023.

A research proposal describes what you will investigate, why it’s important, and how you will conduct your research.

The format of a research proposal varies between fields, but most proposals will contain at least these elements:

Introduction

Literature review.

• Research design

Reference list

While the sections may vary, the overall objective is always the same. A research proposal serves as a blueprint and guide for your research plan, helping you get organized and feel confident in the path forward you choose to take.

Table of contents

Research proposal purpose, research proposal examples, research design and methods, contribution to knowledge, research schedule, other interesting articles, frequently asked questions about research proposals.

Academics often have to write research proposals to get funding for their projects. As a student, you might have to write a research proposal as part of a grad school application , or prior to starting your thesis or dissertation .

In addition to helping you figure out what your research can look like, a proposal can also serve to demonstrate why your project is worth pursuing to a funder, educational institution, or supervisor.

Research proposal length

The length of a research proposal can vary quite a bit. A bachelor’s or master’s thesis proposal can be just a few pages, while proposals for PhD dissertations or research funding are usually much longer and more detailed. Your supervisor can help you determine the best length for your work.

One trick to get started is to think of your proposal’s structure as a shorter version of your thesis or dissertation , only without the results , conclusion and discussion sections.

Download our research proposal template

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Writing a research proposal can be quite challenging, but a good starting point could be to look at some examples. We’ve included a few for you below.

• Example research proposal #1: “A Conceptual Framework for Scheduling Constraint Management”
• Example research proposal #2: “Medical Students as Mediators of Change in Tobacco Use”

Like your dissertation or thesis, the proposal will usually have a title page that includes:

• The proposed title of your project
• Your supervisor’s name
• Your institution and department

The first part of your proposal is the initial pitch for your project. Make sure it succinctly explains what you want to do and why.

Your introduction should:

• Introduce your topic
• Give necessary background and context
• Outline your  problem statement  and research questions

To guide your introduction , include information about:

• Who could have an interest in the topic (e.g., scientists, policymakers)
• How much is already known about the topic
• What is missing from this current knowledge
• What new insights your research will contribute
• Why you believe this research is worth doing

As you get started, it’s important to demonstrate that you’re familiar with the most important research on your topic. A strong literature review  shows your reader that your project has a solid foundation in existing knowledge or theory. It also shows that you’re not simply repeating what other people have already done or said, but rather using existing research as a jumping-off point for your own.

In this section, share exactly how your project will contribute to ongoing conversations in the field by:

• Comparing and contrasting the main theories, methods, and debates
• Examining the strengths and weaknesses of different approaches
• Explaining how will you build on, challenge, or synthesize prior scholarship

Following the literature review, restate your main  objectives . This brings the focus back to your own project. Next, your research design or methodology section will describe your overall approach, and the practical steps you will take to answer your research questions.

To finish your proposal on a strong note, explore the potential implications of your research for your field. Emphasize again what you aim to contribute and why it matters.

For example, your results might have implications for:

• Improving best practices
• Informing policymaking decisions
• Strengthening a theory or model
• Challenging popular or scientific beliefs
• Creating a basis for future research

Last but not least, your research proposal must include correct citations for every source you have used, compiled in a reference list . To create citations quickly and easily, you can use our free APA citation generator .

Some institutions or funders require a detailed timeline of the project, asking you to forecast what you will do at each stage and how long it may take. While not always required, be sure to check the requirements of your project.

Here’s an example schedule to help you get started. You can also download a template at the button below.

Download our research schedule template

If you are applying for research funding, chances are you will have to include a detailed budget. This shows your estimates of how much each part of your project will cost.

Make sure to check what type of costs the funding body will agree to cover. For each item, include:

• Cost : exactly how much money do you need?
• Justification : why is this cost necessary to complete the research?
• Source : how did you calculate the amount?

To determine your budget, think about:

• Travel costs : do you need to go somewhere to collect your data? How will you get there, and how much time will you need? What will you do there (e.g., interviews, archival research)?
• Materials : do you need access to any tools or technologies?
• Help : do you need to hire any research assistants for the project? What will they do, and how much will you pay them?

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

Methodology

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

Once you’ve decided on your research objectives , you need to explain them in your paper, at the end of your problem statement .

Keep your research objectives clear and concise, and use appropriate verbs to accurately convey the work that you will carry out for each one.

I will compare …

A research aim is a broad statement indicating the general purpose of your research project. It should appear in your introduction at the end of your problem statement , before your research objectives.

Research objectives are more specific than your research aim. They indicate the specific ways you’ll address the overarching aim.

A PhD, which is short for philosophiae doctor (doctor of philosophy in Latin), is the highest university degree that can be obtained. In a PhD, students spend 3–5 years writing a dissertation , which aims to make a significant, original contribution to current knowledge.

A PhD is intended to prepare students for a career as a researcher, whether that be in academia, the public sector, or the private sector.

A master’s is a 1- or 2-year graduate degree that can prepare you for a variety of careers.

All master’s involve graduate-level coursework. Some are research-intensive and intend to prepare students for further study in a PhD; these usually require their students to write a master’s thesis . Others focus on professional training for a specific career.

Critical thinking refers to the ability to evaluate information and to be aware of biases or assumptions, including your own.

Like information literacy , it involves evaluating arguments, identifying and solving problems in an objective and systematic way, and clearly communicating your ideas.

The best way to remember the difference between a research plan and a research proposal is that they have fundamentally different audiences. A research plan helps you, the researcher, organize your thoughts. On the other hand, a dissertation proposal or research proposal aims to convince others (e.g., a supervisor, a funding body, or a dissertation committee) that your research topic is relevant and worthy of being conducted.

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• Indian J Dermatol
• v.62(5); Sep-Oct 2017

Summary and Synthesis: How to Present a Research Proposal

Maninder singh setia.

From the MGM Institute of Health Sciences, Navi Mumbai, Maharashtra, India

Saumya Panda

1 Department of Dermatology, KPC Medical College, Kolkata, West Bengal, India

This concluding module attempts to synthesize the key learning points discussed during the course of the previous ten sets of modules on methodology and biostatistics. The objective of this module is to discuss how to present a model research proposal, based on whatever was discussed in the preceding modules. The lynchpin of a research proposal is the protocol, and the key component of a protocol is the study design. However, one must not neglect the other areas, be it the project summary through which one catches the eyes of the reviewer of the proposal, or the background and the literature review, or the aims and objectives of the study. Two critical areas in the “methods” section that cannot be emphasized more are the sampling strategy and a formal estimation of sample size. Without a legitimate sample size, none of the conclusions based on the statistical analysis would be valid. Finally, the ethical parameters of the study should be well understood by the researchers, and that should get reflected in the proposal.

As we reach the end of an exhaustive module encompassing research methods and biostatistics, we need to summarize and synthesize the key learning points, to demonstrate how one may utilize the different sections of the module to undertake research projects of different kinds. After all, the practical purpose behind publishing such a module is to facilitate the preparation of high quality research proposals and protocols. This concluding part will make an attempt to provide a window to the different sections of the module, underlining the various aspects of design and analysis needed to formulate protocols applicable to different kinds of clinical research in dermatology.

Components of a Research Proposal

The goal of a research proposal is to present and justify the need to study a research problem and to present the practical ways in which the proposed study should be conducted. A research proposal is generally meant to be presented by an investigator to request an agency or a body to support research work in the form of grants. The vast majority of research proposals, in India, however, are not submitted to agency or body for grants, simply because of the paucity of such agencies, bodies, and research grants. Most are academic research proposals, self-financed, and submitted to scientific and ethics committee of an institution. The parts of a proposal include the title page, abstract/project summary, table of contents, introduction, background and review of literature, and the research protocol.

The title page should contain the personal data pertaining to the investigators, and title of the project, which should be concise and comprehensive at the same time. The table of contents, strictly speaking, is not necessary for short proposals. The introduction includes a statement of the problem, purpose, and significance of the research.

The protocol is the document that specifies the research plan. It is the single most important quality control tool for all aspects of a clinical research. It is the instrument where the researcher explains how data will be collected, including the calculation for estimating sample size, and what outcome variables to measure.

A complete clinical research protocol includes the following:

Study design

• Precise definition of the disease or problem
• Completely defined prespecified primary and secondary outcome measures, including how and when these will be assessed
• Clear description of variables
• Well-defined inclusion and exclusion criteria
• Efficacy and safety parameters
• Whenever applicable, stopping guidelines and parameters of interim analyses
• Sample size calculation
• Randomization details
• Plan of statistical analysis
• Detailed description of interventions
• A chronogram of research flow (Gantt chart)
• Informed consent document
• Clinical research form
• Details of budget; and
• References.

(Modified from: Bagatin et al ., 2013).

Project Summary

The project summary is a brief document that consists of an overview, and discusses the intellectual merits, and broader impacts of the research project. Each of these three sections is required to be present and must be clearly defined. The project summary is one of the most important parts of the proposal. It is likely the first thing a reviewer will read, and is the investigators’ best chance to grab their interest, and convince them of the importance, and quality, of their research before they even read the proposal. Though it is the first proposal element in order, many applicants prefer to write the project summary last, after writing the protocol. This allows the writer to better avoid any inconsistencies between the two.

The overview specifies the research goal and it should demonstrate that this goal fits with the principal investigator's long-term research goals. It should specify the proposed research approach and the educational goal of the research project.

The intellectual merits (the contribution your research will make to your field) should specify the current state of knowledge in the field, and where it is headed. It should also clarify what your research will add to the state of knowledge in the field. Furthermore, important to state is what your research will do to enhance or enable other researches in the field. Finally, one should answer why your research is important for the advancement of the field.

The broader impacts (the contribution the research will make to the society) should answer the questions on the benefit to the society at large from the research, and the possible applications of the research, and why the general public would care. It should also clarify how the research can benefit the site of research (medical college or university, etc.) and the funding agency.

Background and Review of Literature

This is an important component of the research protocol. The review should discuss all the relevant literature, the method used in the literature, the lacunae in the literature, and justify the proposed research. We have provided a list of the useful databases in the section on systematic reviews and meta-analysis (Setia, 2017). Some of these are PubMed, Cochrane database, EMBASE, and LILACS.

Provide a critical analysis of the literature

The researcher should not provide a descriptive analysis of literature. For instance, the literature reviews should not be a list of one article followed by the next article. It should be a critical analysis of literature.

A study by XXXX et al . found that the prevalence of psoriasis was 20%. It was a hospital-based study conducted in North India. The prevalence was 35% in males and 12% in females.

Another study by YYYYY et al . found that the prevalence of psoriasis was 14%. The study was conducted in a private clinic in North India. The prevalence was 8% in males and 18% in females.

A third study by ZZZZZ et al . found that the prevalence of psoriasis was 5%. This study was a community-based study. The prevalence was 7% in males and 3% in females.

In this type of review, the researcher has described all the studies. However, it is useful to understand the findings of these three studies and summarize them in researcher's own words.

A possible option can be “ The reported prevalence of psoriasis in the Indian population varied from 5% to 20%. In general, it was higher in hospital-based studies and lower in community-based studies. There was no consistent pattern in the prevalence of psoriasis in males and females. Though some studies found the prevalence to be higher in males, others reported that females had a higher prevalence .”

Discuss the limitations and lacunae of these studies

The researcher should discuss the limitations of the studies. These could be the limitations that the authors have presented in the manuscript or the ones that the researcher has identified. Usually, the current research proposal should try to address the limitations of a previous study.

A study by BBBB et al : “ One of the main limitations of our study was the lack of objective criteria for assessing anemia in patients presenting with psoriasis. We classified the patients based on clinical assessment of pallor .”

The present proposal can mention “ Though previous studies have assessed the association between anemia and psoriasis, they have not used any objective criteria (such as hemoglobin or serum ferritin levels). Furthermore, pallor was evaluated by three clinicians; the authors have not described the agreement between these clinicians .”

In the above example, the authors have stated the limitation of their research in the manuscript. However, in the review of literature, the researcher has added another limitation. It is important to convince the reviewers that the researcher has read and understood the literature. It is also important that some or most of these lacunae should be addressed in the present proposal as far as possible.

Justify the present proposal by review

The researcher should adequately justify the present proposal based on the review of literature. The justification should not only be for the research question, but also the methods, study design, variables of interest, study instruments or measurements, and statistical methods of choice. Sometimes, the justification can be purely statistical. For example, all the previous studies have used cross-sectional data or cross-sectional analysis of longitudinal data in their manuscripts. The present proposal will use methods used for longitudinal data analysis. The researcher should justify the benefit of these methods over the previous statistical methods.

In short, the review should not be a “laundry list” of all the articles. The review should be able to convince the reader that the present research is required and it builds on the existing literature (either as a novel research question, new measurement of the outcome, a better study design, or advanced and appropriate statistical methods).

Kindly try to avoid this justification: “ It has not been done in our center .”

Aims and Objectives

The “aim” of the study is an overarching goal of the study. The objectives are measurable and help the researcher achieve the overall aim.

For example, the overall aim of our study is to assess the long-term health of patients of psoriasis.

The specific objectives are:

• To record the changes in Psoriasis Area and Severity Index (PASI) score in patients with psoriasis over a period of 5 years
• To study the side effects of medications in these patients over a period of 5 years.

It is important to clearly state the objectives, since the research proposal should be designed to achieve these objectives.

For example, the methods should describe the following:

• How will the researcher answer the first objective?
• Where will the researcher recruit the study participants (study site and population)?
• Which patients of psoriasis will be recruited (inclusion and exclusion criteria)?
• What will be the design of the study (cohort, etc.)?
• What are all the variables to be measured to achieve the study outcomes (exposure and outcome variables)?
• How will the researcher measure these variables (clinical evaluation, history, serological examination, etc.)?
• How will the researcher record these data (clinical forms, etc.)?
• How will the researcher analyze the data that have been collected?
• Are there any limitations of these methods? If so, what has the researcher done to minimize the limitations?

All the ten modules on research methodology have to be read and grasped to plan and design any kind of research applicable to one's chosen field. However, some key areas have been outlined below with examples to appreciate the same in an easier manner.

The study setting must be specified. This should include both the geographical location and the population from which the study sample would be recruited.

“The study took place at the antiretroviral therapy clinic of Queen Elizabeth Central Hospital in Blantyre, Malawi, from January 2006 to April 2007. Blantyre is the major commercial city of Malawi, with a population of 1,000,000 and an estimated HIV prevalence of 27% in adults in 2004” (Ndekha et al ., 2009).

This is a perfect example of description of a study setting which underscores the importance of planning it in detail a priori .

Study population, sampling strategy, and sample size

Study population has to be clearly and precisely defined. For example, a study on atopic dermatitis may be conducted upon patients defined according to the UK Working Party's modified diagnostic criteria, or the Hanifin and Rajka's criteria, or some other criteria defined by the investigators. However, it should always be prespecified within the protocol.

Similarly, the eligibility criteria of the participants for the study must be explicit. One truism that is frequently forgotten is that the inclusion and exclusion criteria are mutually exclusive, and one is not the negative image of the other. Eligible cases are included according to a set of inclusion criteria, and this is followed by administration of the exclusion criteria. Thus, in fact, they can never be the negative image of each other.

“Eligible participants were all adults aged 18 or over with HIV who met the eligibility criteria for antiretroviral therapy according to the Malawian national HIV treatment guidelines (WHO clinical stage III or IV or any WHO stage with a CD4 count < 250/mm 3 ) and who were starting treatment with a BMI < 18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding program” (Ndekha et al ., 2009).

To put in perspective the point we made about inclusion and exclusion criteria, in the above example, “age above 18 years” or “CD4 count >250/mm 3 ” cannot be exclusion criteria, as these have already been excluded.

Sampling strategy has been adequately discussed in the Module 5 of the Methodology series (Setia, 2016). A few points are worth repeating:

• The sampling strategy should never be misrepresented. Example: If you have not done random sampling, no big deal. There are other legitimate sampling strategies available for your study. But once you have mentioned “random sampling” in your protocol, you cannot resort to purposive sampling
• Sometimes, the researcher might want to know the characteristics of a certain problem within a specific population, without caring for generalizability of results. In such a scenario, purposive sampling may be resorted to
• Nonprobability sampling methods such as consecutive consenting sampling or any such convenience sampling are perfectly legitimate and easy to do, particularly in case of dissertations where time and resources are limited.

Sample size is one of the most misunderstood, yet fundamentally important, issues among clinicians and has to be addressed once the study objectives have been set and the design has been finalized. Too small a sample means that there would be a failure to detect change following test intervention. A sample larger than necessary may also result in bad quality data. In either case, there would be ethical problems and wastage of resources. The researcher needs just enough samples to draw accurate inferences, which would be adequately powered (Panda, 2015).

Estimation of sample size has been dealt with adequately in the Module 5 biostatistics series (Hazra et al ., 2016), including the different mathematical derivations and the available software. Sample size determination is a statistical exercise based on the probability of errors in testing of hypothesis, power of the sample, and effect size. Although, relatively speaking, these are simple concepts to grasp, a large number of different study designs and analytical methods lead to a bewilderingly large number of formulae for determining sample size. Thus, the software are really handy and are becoming increasingly popular.

The study design defines the objectives and end points of the study, the type and manner of data collection, and the strategy of data analysis (Panda 2015). The different types of clinical studies have been depicted in Figure 1 . The suitability of various study designs vis-à-vis different types of research questions is summarized in Table 1 .

Types of study (Source: Panda, 2015)

Research questions vis-a-vis study designs

In our previous series of ten modules on methodology, we have discussed all these different kinds of studies and more. Some key issues that require reiteration are given below:

• The control of a case–control study and that of a randomized controlled trial is more different from each other than chalk is from cheese. The former is an observational study, while the latter is an interventional one. Every study with a control group is not a case–control study. For a study to be classified as a case–control study, the study should be an observational study and the participants should be recruited based on their outcome status (Setia, 2016). Apparently, this is not so difficult to understand, yet even now we have publications which confuse between the different kinds of controls (Bhanja et al ., 2015)
• Due to the fact that the outcome and exposure are assessed at the same time point in a cross-sectional study, it is pretty difficult, if not impossible, to derive causal relationships from such a study. At most, one may establish statistical association between exposures and outcomes by calculating the odds ratio. However, these associations must not be confused with causation.
• It is generally said that a cohort design may not be efficient for rare outcomes. However, if the rare outcome is common in some exposures, it may be useful to follow a cohort design. For example, melanoma is a rare condition in India. Hence, if we follow individuals to study the incidence of melanoma, it may not be efficient. However, if we know that, in India, acral lentiginous melanoma is the most commonly reported variant, we should follow a cohort of individuals with acral lentiginous and study the incidence of melanoma in this group (Setia, 2016).

Clinical researchers should also be accustomed with observational designs beyond case–control, cohort, and cross-sectional studies. Sometimes, the unit of analysis has to be a group or aggregate rather than the individual. Consider the following example:

The government introduced the supplementation of salt with iodine for about 20 years. However, not all states have used the same level of iodine in salt. Certain hilly states have used higher quantities compared with other states. Incidentally, you read a report that high iodine levels are associated with psoriasis. You are intrigued to find if introduction of iodine has altered the picture of psoriasis in the country. You feel compelled to design a study to answer this question .

It is obvious that here the unit of study cannot be individuals, but a large population distributed in a certain geographical area. This is the domain of ecologic studies. An allied category of observational studies is named “natural experiments,” where the exposure is not assigned by the investigator (as in an interventional study), but through “natural processes.” These may be through changes in the existing regulations or public policies or, may be, through introduction of new laws (Setia, 2017).

Another category of research questions that cannot be satisfactorily captured by all the quantitative methods described earlier, like social stigma experienced by patients or their families with, say, vitiligo, leprosy, or sexually transmitted infections, are best dealt with by qualitative research. As can be seen by the examples given above, this is a type of research which is very relevant to medical research, yet to which the regular medical researcher has got a very poor exposure, if any. We shall encourage interested researchers to take a look at the 10 th Module of the Methodology series that specifically deals with qualitative research (Setia, 2017).

Clinical studies are experiments that are not conducted in laboratories but in controlled real-life settings on human subjects with some disease. Hence, designing a study involves many pragmatic considerations aside pure methodology. Thus, factors to consider when selecting a study design are objectives of the study, time frame, treatment duration, carryover effects, cost and logistics, patient convenience, statistical considerations, sample size, etc. (Panda, 2015).

Certain truisms regarding study designs should always be remembered: a study design has to be tailored to objectives. The same question may be answered by different designs. The optimum design has to be based on workforce, budgetary allocation, infrastructure, and clinical material that may be commanded by the researchers. Finally, no design is perfect, and there is no design to provide a perfect answer to all research questions relevant to a particular problem (Panda, 2015).

Variables of interest and collection of these variables

Data structure depends on the characteristics of the variables [ Figure 2 ]. A variable refers to a particular character on which a set of data are recorded. Data are thus the values of a variable (Hazra et al ., 2016).

Types of data and variables (Source: Panda, 2015)

Quantitative data always have a proportional scale among values, and can be either discrete (e.g., number of moles) or continuous (e.g., age). Qualitative data can be either nominal (e.g., blood groups) or ordinal (e.g., Fitzpatrick's phototypes I-VI). Variables can be binary or dichotomous (male/female) or multinomial or polychotomous (homosexual/bisexual/heterosexual) (Panda, 2015).

Changing data scales is possible so that numerical data may become ordinal and ordinal data may become nominal. This may be done when the researcher is not confident about the accuracy of the measuring instrument, is unconcerned about the loss of fine detail, or where group numbers are not large enough to adequately represent a variable of interest. It may also make clinical interpretation easier (Hazra et al ., 2016).

The variables whose effects are observed on other variables are known as independent variables (e.g., risk factors). The latter kind of variables that change as a result of independent variables are known as dependent variables (i.e., outcome). Confounders are those variables that influence the relation between independent and dependent variables (e.g., the clinical effect of sunscreen used as part of a test intervention regimen in melasma). If the researcher fails to control or eliminate the confounder, it will damage the internal validity of an experiment (Panda, 2015).

Biostatistics begins with descriptive statistics that implies summarizing a collection of data from a sample or population. An excellent overview of descriptive statistics has been given in the Module 1 of the Biostatistics series (Hazra et al ., 2016). We would encourage every researcher to embark on designing and collecting data on their own to go through this particular module to have a clear idea on how to proceed further.

Statistical methods

As briefly discussed earlier, the “methods” section should also include a detailed description of statistical methods. It is best to describe the methods for each objective.

For example: Which statistical methods will the researcher use to study the changes in PASI score over time?

It is important to first identify the nature of the outcome – will it be linear or categorical?

• It may be noticed that the PASI is a score and can range from 0 to 72. The researcher can measure the actual score and assess the changes in score. Thus, the researcher will use methods for statistical analysis of continuous data (such as means, standard deviations, t -test, or linear regressions)
• However, the researcher may choose to cut off the PASI score at 60 (of course, there has to be justification!) and call it severe psoriasis. Thus, the researcher will have an outcome variable with two outcomes (Yes: >60 PASI, and No: <60 PASI). Thus, in this case, the researcher will use methods for statistical analysis of categorical data (proportions, Chi-square test, or logistic regression models).

The statistical methods have been described in detail in the Biostatistics section of the series. The reader is encouraged to read all the sections to understand these methods. However, the key points to remember are:

• Identify the nature of the outcome for each objective
• Describe the statistical methods separately for each objective
• Identify the methods to handle confounding and describe them in the statistical methods
• If the researcher is using advanced statistical methods or specific tools, please provide reference to these methods
• Provide the name of the statistical software (including the version) that will be used for data analysis in the present study
• Do not provide a laundry list of all the statistical methods. It just shows that the researcher has not understood the relevance of statistics in the study design.

Multivariate models

In general, multivariate analyses are used in studies and research proposals. These analyses are useful to adjust for confounding (though these are also useful to test for interaction, we shall discuss confounding in this section). For example, we propose to compare two different types of medications in psoriasis. We have used secondary clinical data for this study. The outcome of interest is PASI score. We have collected data on the type of medication, age, sex, and alcohol use. When we compare the PASI score in these two groups, we will use t -test (if linear comparison) or Chi-square test (if PASI is categorized – as described earlier). However, it is possible that age, sex, and alcohol use may also play a role in the clinical progression of psoriasis (which is measured as PASI score). Thus, the researcher would like to account for differences in these variables in the two groups. This can be done using multivariate analytical methods (such as linear regression for continuous variables and logistic regression for categorical dichotomous variables). This is a type of mathematical model in which we include multiple variables: the main explanatory variable (type of drug in this study) and potential confounders (age, sex, and alcohol use in this study). Thus, the outcome (PASI score) after multivariate analyses will be “adjusted” for age, sex, and alcohol use after multivariate analysis. We would like to encourage the readers to consult a statistician for these methods.

TRIVIA: The singular for “data” is “datum,” just as “stratum” is the singular for “strata.” Thus, “ data were analyzed …,” “ data were collected …,” and “ data have been ….”

Clinical Record Forms

We have discussed designing of questionnaires and clinical record forms (CRFs) in detail in two modules. We shall just highlight the most important aspects in this part. The CRF is an important part of the research protocol. The CRF should include all the variables of interest in the study. Thus, it is important to make a list of all parameters of interest before working on the CRF. This can be done by a thorough review of literature and discussion with experts. Once the questionnaire/CRF has been designed, the researcher should pilot it and change according to the feedback from the participants and one's own experience while administering the questionnaire or recording data in the CRF. The CRF should use coded responses (for close-ended questions), this will help in data entry and analysis. If the researcher has developed a scale, the reliability and validity should be tested (methods have been discussed in earlier sections). The CRF can be paper based or computer based (it will depend on the resources).

It is very important to describe the ethics for the present study. It should not be restricted to “ The study will be evaluated by an Institutional Review Committee …” The researcher should demonstrate that s/he has understood the various ethical issues in the present study. The three core principles for ethics are: autonomy (the participants have a right to decide whether to participate in the study or opt out), beneficence/nonmaleficence (the study should not be harmful to participants and the risk–benefit ratio should be adequately understood and described), and justice (all the risks and benefits of the present study should be equally distributed).

The researcher should try to address these issues in the section of “Ethics.” Currently, the National Institutes of Health has proposed the following seven principles of “Ethics in Clinical Research:” social and clinical value, scientific validity, fair subject selection, favorable risk–benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects. The Indian Council of Medical Research has also published guidelines to conduct biomedical research in India. We strongly encourage the readers to be familiar with these guidelines. Furthermore, the researchers should keep themselves updated with changes in these regulations. If it is a clinical trial, the researcher should also be familiar with Schedule Y and Consent form requirements for these types of clinical trials.

Concluding Remarks

This module has been designed as a comprehensive guide for a dermatologist to enable him/her to embark on the exciting journey of designing studies of almost any kind that can be thought to be of relevance to clinical dermatology. There has been a conscious attempt to customize the discussion on design and analysis keeping not only dermatology, but also Indian conditions in mind. However, the module can be of help to any medical doctor embarking on the path to medical research. As contributors, it is our ardent hope that this module might act as a catalyst of good-quality research in the field of dermatology and beyond in India and elsewhere.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

Bibliography

What (Exactly) Is A Research Proposal?

A simple explainer with examples + free template.

By: Derek Jansen (MBA) | Reviewed By: Dr Eunice Rautenbach | June 2020 (Updated April 2023)

Whether you’re nearing the end of your degree and your dissertation is on the horizon, or you’re planning to apply for a PhD program, chances are you’ll need to craft a convincing research proposal . If you’re on this page, you’re probably unsure exactly what the research proposal is all about. Well, you’ve come to the right place.

Overview: Research Proposal Basics

• What a research proposal is
• What a research proposal needs to cover
• How to structure your research proposal
• Example /sample proposals
• Proposal writing FAQs
• Key takeaways & additional resources

What is a research proposal?

Simply put, a research proposal is a structured, formal document that explains what you plan to research (your research topic), why it’s worth researching (your justification), and how  you plan to investigate it (your methodology). 

The purpose of the research proposal (its job, so to speak) is to convince  your research supervisor, committee or university that your research is  suitable  (for the requirements of the degree program) and  manageable  (given the time and resource constraints you will face). 

The most important word here is “ convince ” – in other words, your research proposal needs to  sell  your research idea (to whoever is going to approve it). If it doesn’t convince them (of its suitability and manageability), you’ll need to revise and resubmit . This will cost you valuable time, which will either delay the start of your research or eat into its time allowance (which is bad news). 

What goes into a research proposal?

A good dissertation or thesis proposal needs to cover the “ what “, “ why ” and” how ” of the proposed study. Let’s look at each of these attributes in a little more detail:

Your proposal needs to clearly articulate your research topic . This needs to be specific and unambiguous . Your research topic should make it clear exactly what you plan to research and in what context. Here’s an example of a well-articulated research topic:

An investigation into the factors which impact female Generation Y consumer’s likelihood to promote a specific makeup brand to their peers: a British context

As you can see, this topic is extremely clear. From this one line we can see exactly:

• What’s being investigated – factors that make people promote or advocate for a brand of a specific makeup brand
• Who it involves – female Gen-Y consumers
• In what context – the United Kingdom

So, make sure that your research proposal provides a detailed explanation of your research topic . If possible, also briefly outline your research aims and objectives , and perhaps even your research questions (although in some cases you’ll only develop these at a later stage). Needless to say, don’t start writing your proposal until you have a clear topic in mind , or you’ll end up waffling and your research proposal will suffer as a result of this.

Need a helping hand?

As we touched on earlier, it’s not good enough to simply propose a research topic – you need to justify why your topic is original . In other words, what makes it  unique ? What gap in the current literature does it fill? If it’s simply a rehash of the existing research, it’s probably not going to get approval – it needs to be fresh.

But,  originality  alone is not enough. Once you’ve ticked that box, you also need to justify why your proposed topic is  important . In other words, what value will it add to the world if you achieve your research aims?

As an example, let’s look at the sample research topic we mentioned earlier (factors impacting brand advocacy). In this case, if the research could uncover relevant factors, these findings would be very useful to marketers in the cosmetics industry, and would, therefore, have commercial value . That is a clear justification for the research.

So, when you’re crafting your research proposal, remember that it’s not enough for a topic to simply be unique. It needs to be useful and value-creating – and you need to convey that value in your proposal. If you’re struggling to find a research topic that makes the cut, watch  our video covering how to find a research topic .

It’s all good and well to have a great topic that’s original and valuable, but you’re not going to convince anyone to approve it without discussing the practicalities – in other words:

• How will you actually undertake your research (i.e., your methodology)?
• Is your research methodology appropriate given your research aims?
• Is your approach manageable given your constraints (time, money, etc.)?

While it’s generally not expected that you’ll have a fully fleshed-out methodology at the proposal stage, you’ll likely still need to provide a high-level overview of your research methodology . Here are some important questions you’ll need to address in your research proposal:

• Will you take a qualitative , quantitative or mixed -method approach?
• What sampling strategy will you adopt?
• How will you collect your data (e.g., interviews, surveys, etc)?
• How will you analyse your data (e.g., descriptive and inferential statistics , content analysis, discourse analysis, etc, .)?
• What potential limitations will your methodology carry?

So, be sure to give some thought to the practicalities of your research and have at least a basic methodological plan before you start writing up your proposal. If this all sounds rather intimidating, the video below provides a good introduction to research methodology and the key choices you’ll need to make.

How To Structure A Research Proposal

Now that we’ve covered the key points that need to be addressed in a proposal, you may be wondering, “ But how is a research proposal structured? “.

While the exact structure and format required for a research proposal differs from university to university, there are four “essential ingredients” that commonly make up the structure of a research proposal:

• A rich introduction and background to the proposed research
• An initial literature review covering the existing research
• An overview of the proposed research methodology
• A discussion regarding the practicalities (project plans, timelines, etc.)

In the video below, we unpack each of these four sections, step by step.

Research Proposal Examples/Samples

In the video below, we provide a detailed walkthrough of two successful research proposals (Master’s and PhD-level), as well as our popular free proposal template.

Proposal Writing FAQs

How long should a research proposal be.

This varies tremendously, depending on the university, the field of study (e.g., social sciences vs natural sciences), and the level of the degree (e.g. undergraduate, Masters or PhD) – so it’s always best to check with your university what their specific requirements are before you start planning your proposal.

As a rough guide, a formal research proposal at Masters-level often ranges between 2000-3000 words, while a PhD-level proposal can be far more detailed, ranging from 5000-8000 words. In some cases, a rough outline of the topic is all that’s needed, while in other cases, universities expect a very detailed proposal that essentially forms the first three chapters of the dissertation or thesis.

The takeaway – be sure to check with your institution before you start writing.

How do I choose a topic for my research proposal?

Finding a good research topic is a process that involves multiple steps. We cover the topic ideation process in this video post.

How do I write a literature review for my proposal?

While you typically won’t need a comprehensive literature review at the proposal stage, you still need to demonstrate that you’re familiar with the key literature and are able to synthesise it. We explain the literature review process here.

How do I create a timeline and budget for my proposal?

We explain how to craft a project plan/timeline and budget in Research Proposal Bootcamp .

Which referencing format should I use in my research proposal?

The expectations and requirements regarding formatting and referencing vary from institution to institution. Therefore, you’ll need to check this information with your university.

What common proposal writing mistakes do I need to look out for?

We’ve create a video post about some of the most common mistakes students make when writing a proposal – you can access that here . If you’re short on time, here’s a quick summary:

• The research topic is too broad (or just poorly articulated).
• The research aims, objectives and questions don’t align.
• The research topic is not well justified.
• The study has a weak theoretical foundation.
• The research design is not well articulated well enough.
• Poor writing and sloppy presentation.
• Poor project planning and risk management.
• Not following the university’s specific criteria.

Key Takeaways & Additional Resources

As you write up your research proposal, remember the all-important core purpose:  to convince . Your research proposal needs to sell your study in terms of suitability and viability. So, focus on crafting a convincing narrative to ensure a strong proposal.

At the same time, pay close attention to your university’s requirements. While we’ve covered the essentials here, every institution has its own set of expectations and it’s essential that you follow these to maximise your chances of approval.

By the way, we’ve got plenty more resources to help you fast-track your research proposal. Here are some of our most popular resources to get you started:

• Proposal Writing 101 : A Introductory Webinar
• Research Proposal Bootcamp : The Ultimate Online Course
• Template : A basic template to help you craft your proposal

If you’re looking for 1-on-1 support with your research proposal, be sure to check out our private coaching service , where we hold your hand through the proposal development process (and the entire research journey), step by step.

Psst… there’s more!

This post is an extract from our bestselling Udemy Course, Research Proposal Bootcamp . If you want to work smart, you don't want to miss this .

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51 Comments

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Bundle of thanks to you for the research proposal guide it was really good and useful if it is possible please send me the sample of research proposal

You’re most welcome. We don’t have any research proposals that we can share (the students own the intellectual property), but you might find our research proposal template useful: https://gradcoach.com/research-proposal-template/

Cheruiyot Moses Kipyegon

Thanks alot. It was an eye opener that came timely enough before my imminent proposal defense. Thanks, again

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Thank you. This is a great insight. I am a student preparing for a PhD program. I am requested to write my Research Proposal as part of what I am required to submit before my unconditional admission. I am grateful having listened to this video which will go a long way in helping me to actually choose a topic of interest and not just any topic as well as to narrow down the topic and be specific about it. I indeed need more of this especially as am trying to choose a topic suitable for a DBA am about embarking on. Thank you once more. The video is indeed helpful.

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Hi. For my MSc medical education research, please evaluate this topic for me: Training Needs Assessment of Faculty in Medical Training Institutions in Kericho and Bomet Counties

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I need any research proposal

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Home » Chapter Summary & Overview – Writing Guide and Examples

Chapter Summary & Overview – Writing Guide and Examples

Table of Contents

Chapter Summary

Chapter summary is a brief overview of the key points or events covered in a specific chapter of a book, academic paper, or other written work. It typically includes a concise description of the main ideas, arguments, or themes explored in the chapter, as well as any important supporting details or evidence .

Chapter summaries are often used as study aids, providing readers with a quick way to review and understand the content of a particular section of a longer work. They may also be included as part of a book’s table of contents or used as a promotional tool to entice potential readers.

How to Write Chapter Summary

Writing a chapter summary involves condensing the content of a chapter into a shorter, more concise form while still retaining its essential meaning. Here are some steps to help you write a chapter summary:

• Read the chapter carefully: Before summarizing a chapter, it is important to read it thoroughly to ensure that you understand the main ideas and points being made.
• Identify the main ideas: Identify the main ideas and arguments that the chapter is presenting. These may be explicit, or they may be implicit and require some interpretation on your part.
• Make notes: Take notes while reading to help you keep track of the main ideas and arguments. Write down key phrases, important quotes, and any examples or evidence that support the main points.
• Create an outline : Once you have identified the main ideas and arguments, create an outline for your summary. This will help you organize your thoughts and ensure that you include all the important points.
• Write the summary : Using your notes and outline, write a summary of the chapter. Start with a brief introduction that provides context for the chapter, then summarize the main ideas and arguments, and end with a conclusion that ties everything together.
• Edit and revise: After you have written the summary, review it carefully to ensure that it is accurate and concise. Make any necessary edits or revisions to improve the clarity and readability of the summary.
• Check for plagiarism : Finally, check your summary for plagiarism. Make sure that you have not copied any content directly from the chapter without proper citation.

Chapter Summary in Research Paper

In a Research Paper , a Chapter Summary is a brief description of the main points or findings covered in a particular chapter. The summary is typically included at the beginning or end of each chapter and serves as a guide for the reader to quickly understand the content of that chapter.

Here is an example of a chapter summary from a research paper on climate change:

Chapter 2: The Science of Climate Change

In this chapter, we provide an overview of the scientific consensus on climate change. We begin by discussing the greenhouse effect and the role of greenhouse gases in trapping heat in the atmosphere. We then review the evidence for climate change, including temperature records, sea level rise, and changes in the behavior of plants and animals. Finally, we examine the potential impacts of climate change on human society and the natural world. Overall, this chapter provides a foundation for understanding the scientific basis for climate change and the urgency of taking action to address this global challenge.

Chapter Summary in Thesis

In a Thesis , the Chapter Summary is a section that provides a brief overview of the main points covered in each chapter of the thesis. It is usually included at the beginning or end of each chapter and is intended to help the reader understand the key concepts and ideas presented in the chapter.

For example, in a thesis on computer science field, a chapter summary for a chapter on “Machine Learning Algorithms” might include:

Chapter 3: Machine Learning Algorithms

This chapter explores the use of machine learning algorithms in solving complex problems in computer science. We begin by discussing the basics of machine learning, including supervised and unsupervised learning, as well as different types of algorithms such as decision trees, neural networks, and support vector machines. We then present a case study on the application of machine learning algorithms in image recognition, demonstrating how these algorithms can improve accuracy and reduce error rates. Finally, we discuss the limitations and challenges of using machine learning algorithms, including issues of bias and overfitting. Overall, this chapter highlights the potential of machine learning algorithms to revolutionize the field of computer science and drive innovation in a wide range of industries.

Examples of Chapter Summary

Some Examples of Chapter Summary are as follows:

Research Title: “The Impact of Social Media on Mental Health: A Review of the Literature”

Chapter Summary:

Chapter 1: Introduction

This chapter provides an overview of the research problem, which is the impact of social media on mental health. It presents the purpose of the study, the research questions, and the methodology used to conduct the research.

Research Title : “The Effects of Exercise on Cognitive Functioning in Older Adults: A Meta-Analysis”

Chapter 2: Literature Review

This chapter reviews the existing literature on the effects of exercise on cognitive functioning in older adults. It provides an overview of the theoretical framework and previous research findings related to the topic. The chapter concludes with a summary of the research gaps and limitations.

Research Title: “The Role of Emotional Intelligence in Leadership Effectiveness: A Case Study of Successful Business Leaders”

Chapter 3: Methodology

This chapter presents the research methodology used in the study, which is a case study approach. It describes the selection criteria for the participants and the data collection methods used. The chapter also provides a detailed explanation of the data analysis techniques used in the study.

Research Title: “Factors Influencing Employee Engagement in the Workplace: A Systematic Review”

Chapter 4: Results and Discussion

This chapter presents the findings of the systematic review on the factors influencing employee engagement in the workplace. It provides a detailed analysis of the results, including the strengths and limitations of the studies reviewed. The chapter also discusses the implications of the findings for practice and future research.

Purpose of Chapter Summary

Some Purposes of the Chapter Summary are as follows:

• Comprehension : A chapter summary can help readers understand the main points of a chapter or book. It can help readers remember important details, keep track of the plot or argument, and connect the key ideas.
• Review : A chapter summary can be a useful tool for reviewing the material covered in a chapter. It can help readers review the content quickly and efficiently, and it can also serve as a reference for future study.
• Study aid: A chapter summary can be used as a study aid, especially for students who are preparing for exams or writing papers. It can help students organize their thoughts and focus on the most important information.
• Teaching tool: A chapter summary can be a useful teaching tool for educators. It can help teachers introduce key concepts and ideas, facilitate class discussion, and assess student understanding.
• Communication : A chapter summary can be used as a way to communicate the main ideas of a chapter or book to others. It can be used in presentations, reports, and other forms of communication to convey important information quickly and concisely.
• Time-saving : A chapter summary can save time for busy readers who may not have the time to read an entire book or chapter in detail. By providing a brief overview of the main points, a chapter summary can help readers determine whether a book or chapter is worth further reading.
• Accessibility : A chapter summary can make complex or technical information more accessible to a wider audience. It can help break down complex ideas into simpler terms and provide a clear and concise explanation of key concepts.
• Analysis : A chapter summary can be used as a starting point for analysis and discussion. It can help readers identify themes, motifs, and other literary devices used in the chapter or book, and it can serve as a jumping-off point for further analysis.
• Personal growth : A chapter summary can be used for personal growth and development. It can help readers gain new insights, learn new skills, and develop a deeper understanding of the world around them.

When to Write Chapter Summary

Chapter summaries are usually written after you have finished reading a chapter or a book. Writing a chapter summary can be useful for several reasons, including:

• Retention : Summarizing a chapter helps you to better retain the information you have read.
• Studying : Chapter summaries can be a useful study tool when preparing for exams or writing papers.
• Review : When you need to review a book or chapter quickly, a summary can help you to refresh your memory.
• Analysis : Summarizing a chapter can help you to identify the main themes and ideas of a book, which can be useful when analyzing it.

Advantages of Chapter Summary

Chapter summaries have several advantages:

• Helps with retention : Summarizing the key points of a chapter can help you remember important information better. By condensing the information, you can identify the main ideas and focus on the most relevant points.
• Saves time : Instead of re-reading the entire chapter when you need to review information, a summary can help you quickly refresh your memory. It can also save time during note-taking and studying.
• Provides an overview : A summary can give you a quick overview of the chapter’s content and help you identify the main themes and ideas. This can help you understand the broader context of the material.
• Helps with comprehension : Summarizing the content of a chapter can help you better understand the material. It can also help you identify any areas where you might need more clarification or further study.
• Useful for review: Chapter summaries can be a useful review tool before exams or when writing papers. They can help you organize your thoughts and review key concepts and ideas.
• Facilitates discussion: When working in a group, chapter summaries can help facilitate discussion and ensure that everyone is on the same page. It can also help to identify areas of confusion or disagreement.
• Supports active reading : Creating a summary requires active reading, which means that you are engaging with the material and thinking critically about it. This can help you develop stronger reading and critical thinking skills.
• Enables comparison : When reading multiple sources on a topic, creating summaries of each chapter can help you compare and contrast the information presented. This can help you identify differences and similarities in the arguments and ideas presented.
• Helpful for long texts: In longer books or texts, chapter summaries can be especially helpful. They can help you break down the material into manageable chunks and make it easier to digest.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Chapter 14: The Research Proposal

14.3 Components of a Research Proposal

Krathwohl (2005) suggests and describes a variety of components to include in a research proposal. The following sections – Introductions, Background and significance, Literature Review; Research design and methods, Preliminary suppositions and implications; and Conclusion present these components in a suggested template for you to follow in the preparation of your research proposal.

Introduction

The introduction sets the tone for what follows in your research proposal – treat it as the initial pitch of your idea. After reading the introduction your reader should:

• understand what it is you want to do;
• have a sense of your passion for the topic; and
• be excited about the study’s possible outcomes.

As you begin writing your research proposal, it is helpful to think of the introduction as a narrative of what it is you want to do, written in one to three paragraphs. Within those one to three paragraphs, it is important to briefly answer the following questions:

• What is the central research problem?
• How is the topic of your research proposal related to the problem?
• What methods will you utilize to analyze the research problem?
• Why is it important to undertake this research? What is the significance of your proposed research? Why are the outcomes of your proposed research important? Whom are they important?

Note : You may be asked by your instructor to include an abstract with your research proposal. In such cases, an abstract should provide an overview of what it is you plan to study, your main research question, a brief explanation of your methods to answer the research question, and your expected findings. All of this information must be carefully crafted in 150 to 250 words. A word of advice is to save the writing of your abstract until the very end of your research proposal preparation. If you are asked to provide an abstract, you should include 5 to 7 key words that are of most relevance to your study. List these in order of relevance.

Background and significance

The purpose of this section is to explain the context of your proposal and to describe, in detail, why it is important to undertake this research. Assume that the person or people who will read your research proposal know nothing or very little about the research problem. While you do not need to include all knowledge you have learned about your topic in this section, it is important to ensure that you include the most relevant material that will help to explain the goals of your research.

While there are no hard and fast rules, you should attempt to address some or all of the following key points:

• State the research problem and provide a more thorough explanation about the purpose of the study than what you stated in the introduction.
• Present the rationale for the proposed research study. Clearly indicate why this research is worth doing. Answer the “so what?” question.
• Describe the major issues or problems to be addressed by your research. Do not forget to explain how and in what ways your proposed research builds upon previous related research.
• Explain how you plan to go about conducting your research.
• Clearly identify the key or most relevant sources of research you intend to use and explain how they will contribute to your analysis of the topic.
• Set the boundaries of your proposed research, in order to provide a clear focus. Where appropriate, state not only what you will study, but what will be excluded from your study.
• Provide clear definitions of key concepts and terms. Since key concepts and terms often have numerous definitions, make sure you state which definition you will be utilizing in your research.

Literature review

This key component of the research proposal is the most time-consuming aspect in the preparation of your research proposal. As described in Chapter 5 , the literature review provides the background to your study and demonstrates the significance of the proposed research. Specifically, it is a review and synthesis of prior research that is related to the problem you are setting forth to investigate. Essentially, your goal in the literature review is to place your research study within the larger whole of what has been studied in the past, while demonstrating to your reader that your work is original, innovative, and adds to the larger whole.

As the literature review is information dense, it is essential that this section be intelligently structured to enable your reader to grasp the key arguments underpinning your study. However, this can be easier to state and harder to do, simply due to the fact there is usually a plethora of related research to sift through. Consequently, a good strategy for writing the literature review is to break the literature into conceptual categories or themes, rather than attempting to describe various groups of literature you reviewed. Chapter 5   describes a variety of methods to help you organize the themes.

Here are some suggestions on how to approach the writing of your literature review:

• Think about what questions other researchers have asked, what methods they used, what they found, and what they recommended based upon their findings.
• Do not be afraid to challenge previous related research findings and/or conclusions.
• Assess what you believe to be missing from previous research and explain how your research fills in this gap and/or extends previous research.

It is important to note that a significant challenge related to undertaking a literature review is knowing when to stop. As such, it is important to know when you have uncovered the key conceptual categories underlying your research topic. Generally, when you start to see repetition in the conclusions or recommendations, you can have confidence that you have covered all of the significant conceptual categories in your literature review. However, it is also important to acknowledge that researchers often find themselves returning to the literature as they collect and analyze their data. For example, an unexpected finding may develop as you collect and/or analyze the data; in this case, it is important to take the time to step back and review the literature again, to ensure that no other researchers have found a similar finding. This may include looking to research outside your field.

This situation occurred with one of this textbook’s authors’ research related to community resilience. During the interviews, the researchers heard many participants discuss individual resilience factors and how they believed these individual factors helped make the community more resilient, overall. Sheppard and Williams (2016) had not discovered these individual factors in their original literature review on community and environmental resilience. However, when they returned to the literature to search for individual resilience factors, they discovered a small body of literature in the child and youth psychology field. Consequently, Sheppard and Williams had to go back and add a new section to their literature review on individual resilience factors. Interestingly, their research appeared to be the first research to link individual resilience factors with community resilience factors.

Research design and methods

The objective of this section of the research proposal is to convince the reader that your overall research design and methods of analysis will enable you to solve the research problem you have identified and also enable you to accurately and effectively interpret the results of your research. Consequently, it is critical that the research design and methods section is well-written, clear, and logically organized. This demonstrates to your reader that you know what you are going to do and how you are going to do it. Overall, you want to leave your reader feeling confident that you have what it takes to get this research study completed in a timely fashion.

Essentially, this section of the research proposal should be clearly tied to the specific objectives of your study; however, it is also important to draw upon and include examples from the literature review that relate to your design and intended methods. In other words, you must clearly demonstrate how your study utilizes and builds upon past studies, as it relates to the research design and intended methods. For example, what methods have been used by other researchers in similar studies?

While it is important to consider the methods that other researchers have employed, it is equally, if not more, important to consider what methods have not been but could be employed. Remember, the methods section is not simply a list of tasks to be undertaken. It is also an argument as to why and how the tasks you have outlined will help you investigate the research problem and answer your research question(s).

Tips for writing the research design and methods section:

Specify the methodological approaches you intend to employ to obtain information and the techniques you will use to analyze the data.

Specify the research operations you will undertake and the way you will interpret the results of those operations in relation to the research problem.

Go beyond stating what you hope to achieve through the methods you have chosen. State how you will actually implement the methods (i.e., coding interview text, running regression analysis, etc.).

Anticipate and acknowledge any potential barriers you may encounter when undertaking your research, and describe how you will address these barriers.

Explain where you believe you will find challenges related to data collection, including access to participants and information.

Preliminary suppositions and implications

The purpose of this section is to argue how you anticipate that your research will refine, revise, or extend existing knowledge in the area of your study. Depending upon the aims and objectives of your study, you should also discuss how your anticipated findings may impact future research. For example, is it possible that your research may lead to a new policy, theoretical understanding, or method for analyzing data? How might your study influence future studies? What might your study mean for future practitioners working in the field? Who or what might benefit from your study? How might your study contribute to social, economic or environmental issues? While it is important to think about and discuss possibilities such as these, it is equally important to be realistic in stating your anticipated findings. In other words, you do not want to delve into idle speculation. Rather, the purpose here is to reflect upon gaps in the current body of literature and to describe how you anticipate your research will begin to fill in some or all of those gaps.

The conclusion reiterates the importance and significance of your research proposal, and provides a brief summary of the entire proposed study. Essentially, this section should only be one or two paragraphs in length. Here is a potential outline for your conclusion:

Discuss why the study should be done. Specifically discuss how you expect your study will advance existing knowledge and how your study is unique.

Explain the specific purpose of the study and the research questions that the study will answer.

Explain why the research design and methods chosen for this study are appropriate, and why other designs and methods were not chosen.

State the potential implications you expect to emerge from your proposed study,

Provide a sense of how your study fits within the broader scholarship currently in existence, related to the research problem.

Citations and references

As with any scholarly research paper, you must cite the sources you used in composing your research proposal. In a research proposal, this can take two forms: a reference list or a bibliography. A reference list lists the literature you referenced in the body of your research proposal. All references in the reference list must appear in the body of the research proposal. Remember, it is not acceptable to say “as cited in …” As a researcher you must always go to the original source and check it for yourself. Many errors are made in referencing, even by top researchers, and so it is important not to perpetuate an error made by someone else. While this can be time consuming, it is the proper way to undertake a literature review.

In contrast, a bibliography , is a list of everything you used or cited in your research proposal, with additional citations to any key sources relevant to understanding the research problem. In other words, sources cited in your bibliography may not necessarily appear in the body of your research proposal. Make sure you check with your instructor to see which of the two you are expected to produce.

Overall, your list of citations should be a testament to the fact that you have done a sufficient level of preliminary research to ensure that your project will complement, but not duplicate, previous research efforts. For social sciences, the reference list or bibliography should be prepared in American Psychological Association (APA) referencing format. Usually, the reference list (or bibliography) is not included in the word count of the research proposal. Again, make sure you check with your instructor to confirm.

Research Methods for the Social Sciences: An Introduction Copyright © 2020 by Valerie Sheppard is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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How To Write A Research Summary

It’s a common perception that writing a research summary is a quick and easy task. After all, how hard can jotting down 300 words be? But when you consider the weight those 300 words carry, writing a research summary as a part of your dissertation, essay or compelling draft for your paper instantly becomes daunting task.

A research summary requires you to synthesize a complex research paper into an informative, self-explanatory snapshot. It needs to portray what your article contains. Thus, writing it often comes at the end of the task list.

Regardless of when you’re planning to write, it is no less of a challenge, particularly if you’re doing it for the first time. This blog will take you through everything you need to know about research summary so that you have an easier time with it.

What is a Research Summary?

A research summary is the part of your research paper that describes its findings to the audience in a brief yet concise manner. A well-curated research summary represents you and your knowledge about the information written in the research paper.

While writing a quality research summary, you need to discover and identify the significant points in the research and condense it in a more straightforward form. A research summary is like a doorway that provides access to the structure of a research paper's sections.

Since the purpose of a summary is to give an overview of the topic, methodology, and conclusions employed in a paper, it requires an objective approach. No analysis or criticism.

Research summary or Abstract. What’s the Difference?

They’re both brief, concise, and give an overview of an aspect of the research paper. So, it’s easy to understand why many new researchers get the two confused. However, a research summary and abstract are two very different things with individual purpose. To start with, a research summary is written at the end while the abstract comes at the beginning of a research paper.

A research summary captures the essence of the paper at the end of your document. It focuses on your topic, methods, and findings. More like a TL;DR, if you will. An abstract, on the other hand, is a description of what your research paper is about. It tells your reader what your topic or hypothesis is, and sets a context around why you have embarked on your research.

Getting Started with a Research Summary

Before you start writing, you need to get insights into your research’s content, style, and organization. There are three fundamental areas of a research summary that you should focus on.

• While deciding the contents of your research summary, you must include a section on its importance as a whole, the techniques, and the tools that were used to formulate the conclusion. Additionally, there needs to be a short but thorough explanation of how the findings of the research paper have a significance.
• To keep the summary well-organized, try to cover the various sections of the research paper in separate paragraphs. Besides, how the idea of particular factual research came up first must be explained in a separate paragraph.
• As a general practice worldwide, research summaries are restricted to 300-400 words. However, if you have chosen a lengthy research paper, try not to exceed the word limit of 10% of the entire research paper.

How to Structure Your Research Summary

The research summary is nothing but a concise form of the entire research paper. Therefore, the structure of a summary stays the same as the paper. So, include all the section titles and write a little about them. The structural elements that a research summary must consist of are:

It represents the topic of the research. Try to phrase it so that it includes the key findings or conclusion of the task.

The abstract gives a context of the research paper. Unlike the abstract at the beginning of a paper, the abstract here, should be very short since you’ll be working with a limited word count.

Introduction

This is the most crucial section of a research summary as it helps readers get familiarized with the topic. You should include the definition of your topic, the current state of the investigation, and practical relevance in this part. Additionally, you should present the problem statement, investigative measures, and any hypothesis in this section.

Methodology

This section provides details about the methodology and the methods adopted to conduct the study. You should write a brief description of the surveys, sampling, type of experiments, statistical analysis, and the rationality behind choosing those particular methods.

Create a list of evidence obtained from the various experiments with a primary analysis, conclusions, and interpretations made upon that. In the paper research paper, you will find the results section as the most detailed and lengthy part. Therefore, you must pick up the key elements and wisely decide which elements are worth including and which are worth skipping.

This is where you present the interpretation of results in the context of their application. Discussion usually covers results, inferences, and theoretical models explaining the obtained values, key strengths, and limitations. All of these are vital elements that you must include in the summary.

Most research papers merge conclusion with discussions. However, depending upon the instructions, you may have to prepare this as a separate section in your research summary. Usually, conclusion revisits the hypothesis and provides the details about the validation or denial about the arguments made in the research paper, based upon how convincing the results were obtained.

The structure of a research summary closely resembles the anatomy of a scholarly article . Additionally, you should keep your research and references limited to authentic and  scholarly sources only.

Tips for Writing a Research Summary

The core concept behind undertaking a research summary is to present a simple and clear understanding of your research paper to the reader. The biggest hurdle while doing that is the number of words you have at your disposal. So, follow the steps below to write a research summary that sticks.

1. Read the parent paper thoroughly

You should go through the research paper thoroughly multiple times to ensure that you have a complete understanding of its contents. A 3-stage reading process helps.

a. Scan: In the first read, go through it to get an understanding of its basic concept and methodologies.

b. Read: For the second step, read the article attentively by going through each section, highlighting the key elements, and subsequently listing the topics that you will include in your research summary.

c. Skim: Flip through the article a few more times to study the interpretation of various experimental results, statistical analysis, and application in different contexts.

Sincerely go through different headings and subheadings as it will allow you to understand the underlying concept of each section. You can try reading the introduction and conclusion simultaneously to understand the motive of the task and how obtained results stay fit to the expected outcome.

2. Identify the key elements in different sections

While exploring different sections of an article, you can try finding answers to simple what, why, and how. Below are a few pointers to give you an idea:

• What is the research question and how is it addressed?
• Is there a hypothesis in the introductory part?
• What type of methods are being adopted?
• What is the sample size for data collection and how is it being analyzed?
• What are the most vital findings?
• Do the results support the hypothesis?

Discussion/Conclusion

• What is the final solution to the problem statement?
• What is the explanation for the obtained results?
• What is the drawn inference?
• What are the various limitations of the study?

3. Prepare the first draft

Now that you’ve listed the key points that the paper tries to demonstrate, you can start writing the summary following the standard structure of a research summary. Just make sure you’re not writing statements from the parent research paper verbatim.

Instead, try writing down each section in your own words. This will not only help in avoiding plagiarism but will also show your complete understanding of the subject. Alternatively, you can use a summarizing tool (AI-based summary generators) to shorten the content or summarize the content without disrupting the actual meaning of the article.

SciSpace Copilot is one such helpful feature! You can easily upload your research paper and ask Copilot to summarize it. You will get an AI-generated, condensed research summary. SciSpace Copilot also enables you to highlight text, clip math and tables, and ask any question relevant to the research paper; it will give you instant answers with deeper context of the article..

4. Include visuals

One of the best ways to summarize and consolidate a research paper is to provide visuals like graphs, charts, pie diagrams, etc.. Visuals make getting across the facts, the past trends, and the probabilistic figures around a concept much more engaging.

5. Double check for plagiarism

It can be very tempting to copy-paste a few statements or the entire paragraphs depending upon the clarity of those sections. But it’s best to stay away from the practice. Even paraphrasing should be done with utmost care and attention.

Also: QuillBot vs SciSpace: Choose the best AI-paraphrasing tool

6. Religiously follow the word count limit

You need to have strict control while writing different sections of a research summary. In many cases, it has been observed that the research summary and the parent research paper become the same length. If that happens, it can lead to discrediting of your efforts and research summary itself. Whatever the standard word limit has been imposed, you must observe that carefully.

7. Proofread your research summary multiple times

The process of writing the research summary can be exhausting and tiring. However, you shouldn’t allow this to become a reason to skip checking your academic writing several times for mistakes like misspellings, grammar, wordiness, and formatting issues. Proofread and edit until you think your research summary can stand out from the others, provided it is drafted perfectly on both technicality and comprehension parameters. You can also seek assistance from editing and proofreading services , and other free tools that help you keep these annoying grammatical errors at bay.

8. Watch while you write

Keep a keen observation of your writing style. You should use the words very precisely, and in any situation, it should not represent your personal opinions on the topic. You should write the entire research summary in utmost impersonal, precise, factually correct, and evidence-based writing.

9. Ask a friend/colleague to help

Once you are done with the final copy of your research summary, you must ask a friend or colleague to read it. You must test whether your friend or colleague could grasp everything without referring to the parent paper. This will help you in ensuring the clarity of the article.

Once you become familiar with the research paper summary concept and understand how to apply the tips discussed above in your current task, summarizing a research summary won’t be that challenging. While traversing the different stages of your academic career, you will face different scenarios where you may have to create several research summaries.

In such cases, you just need to look for answers to simple questions like “Why this study is necessary,” “what were the methods,” “who were the participants,” “what conclusions were drawn from the research,” and “how it is relevant to the wider world.” Once you find out the answers to these questions, you can easily create a good research summary following the standard structure and a precise writing style.

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Consensus GPT vs. SciSpace GPT: Choose the Best GPT for Research

Literature Review and Theoretical Framework: Understanding the Differences

Types of Essays in Academic Writing

• Chapter Summaries
• Project Prep
• Presentations
• Chapter Summary
• Research Topic
• Research Questions
• Research Methodology
• Research Methods

Summary of Chapter 3

Chapter 3 – the research process , paradigms of social research .

• People view social reality in different ways which can constrain their thinking and reasoning.
• Recognizing paradigms is important to see the difference in peoples’ perceptions of the same social phenomenon.
• Subconscious paradigms can interfere with research. 
• Positivism –  knowledge should be only based on what can be observed and measured. 
• Post-positivism – make reasonable inferences by using both observations and reasoning.
• Ontology – how we see the world.
• Functionalism – the world has a social order (ontology) and understanding patterns of events and behaviors is the best approach (epistemology).
• Interpretivism – study the social order through the subjective interpretation of participants.
• Radical Structuralism – seeks to understand or enact change using an objectivist approach.
• Radical humanism – wants to understand social change by using a subjective perspective.
• Scientists are primarily concerned with understanding generalizable behavior, events or phenomena, rather than idiosyncratic or changing events. 

“Our personal paradigms are like ‘colored glasses’ that govern how we view the world and how we structure our thoughts about what we see in the world” (Bhattacharjee, 2012,p. 17).

Overview of the Research Process 

• Observation – observe a phenomenon, event, behavior. 
• Rationalization –  make sense of what you observed.
• Validation – test the theory using the scientific method. 

Steps to the functionalist research process

• Research questions- specific questions about behavior, event, or phenomenon that you want answers to.
• What current knowledge is already available.
• Find key authors, articles, and finding in that area.
• Identify gaps in the knowledge already established.  
• Theories must be chosen based on their problem.
• Research design – plan to answer the research question established in the exploration phase. 
• Operationalization – establishing measurements for abstract constructs.
• Research method – how the researcher wishes to collect data.
• Sampling – taking a smaller portion of the population you are researching to make the experiment more feasible.
• Research proposal – document all the decisions made so far and the reasoning behind those decisions.
• Pilot testing –  helps find potential problems in the research and is ran on a small portion of the target audience.
• Data collection – using the sample population to collect data regarding the research question. 
• Data analysis – analyze the data and explain the conclusions you came to pertaining to the research question.
• Producing a research paper detailing the process and findings of your research.

Common Mistakes in Research 

• Research questions do not answer a problem that a large group of people experiences.
• Working on research that will lose value over time. 
• Using the wrong research method to collect data.
• Collecting data before establishing why the data was collected.
• Problems are not answered because there is not enough information

2 thoughts on “ Summary of Chapter 3 ”

[ I am assuming this is where I should put my Chapter Summary Response]

I was thrilled at the text’s invocation of Thomas Kuhn, then dismayed at the bastardization of Kuhn’s work – particularly the use of the term “paradigm” (a copy of Kuhn’s ‘The Structure of Scientific Revolutions’: https://www.lri.fr/~mbl/Stanford/CS477/papers/Kuhn-SSR-2ndEd.pdf )

More generalizable terms the text might have used: “conceptual schemes” or “conceptual framework”. But that would also dismiss Kuhn’s important (in my opinion) work on science:

“Normal science, the activity in which most scientists inevitably spend almost all their time, is predicated on the assumption that the scientific community knows what the world is like. Much of the success of the enterprise derives from the community’s willingness to defend that assumption, if necessary at considerable cost. Normal science, for example, often suppresses fundamental novelties because they are necessarily subversive of its basic commitments.” (Kuhn, 1962, p 5)

Kuhn’s “paradigm” isn’t a “set of colored glasses” – it is an entire world upon and through which scientific research and analysis is conducted.

Ironically, the text perfectly demonstrates this while it also seemingly contradicts itself: “A well-conducted literature review should indicate whether the initial research questions have already been addressed in the literature (which would obviate the need to study them again)” (p 21). Suggesting that once a “research question” has been addressed, there would be no value in revisiting the very same research is contradicted by the assertion (about Social Science) that “there is a high degree of measurement error in the social sciences and there is considerable uncertainty and little agreement on social science … higher levels of ambiguity, uncertainty, and error that come with such sciences, which merely reflects the high variability of social objects.” (p 2)

The text’s “paradigm” is that Social Science is both fixed (no need to revisit an existing established research question) and also “high[ly] variabl[e]”.

And this very incoherence is where Kuhn’s idea of a “paradigm shift” would be useful – that the degree to which a paradigm can’t sustain the contradictions, a new “paradigm” (scientific revolution) can emerge.

… Kenny

Hey girl!! You did a great job breaking down this chapter. For me, a lot of these concepts are a little more challenging. They really get you thinking about and questioning scientific research. I specifically struggled with paradigms, including positivism and post-positivism. While reading I had similar thoughts as Kenny, “isn’t this text also projecting the paradigm in which they see social science and natural science?”. I think you can enter a rabbit hole if you question the paradigms in which science is based.

Comments are closed.

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Chapter I: Pre-Submission Information

Part I sets forth NSF's proposal preparation and submission guidelines. The coverage provides guidance for the preparation and submission of proposals to NSF. Some NSF programs have program solicitations that modify the general provisions of the PAPPG, and, in such cases, the guidelines provided in the solicitation must be followed.

Chapter I Table of Contents

• NSF Proposal Preparation and Submission
• NSF Programs and Funding Opportunities
• Program Descriptions
• Program Announcements
• Program Solicitations
• Broad Agency Announcements (BAAs)
• Dear Colleague Letters (DCLs)
• Concept Outlines
• Letters of Intent (LOIs)
• Invite/Not Invite Decisions
• Encourage/Discourage Decisions
• Full Proposals
• Categories of Proposers
• Target Dates
• Deadline Dates
• Submission Windows

Special Exceptions to NSF's Deadline Date Policy

Natural or Anthropogenic Events

Closure of NSF

• Submission Instructions
• Requirements Relating to Unique Entity Identifier (UEI)and Registration in the System for Award Management (SAM)
• Proposal Receipt
• Proposal Processing

A. NSF Proposal Preparation and Submission

Unless specified in an NSF program solicitation, proposals submitted to NSF must be submitted via use of Research.gov, Grants.gov, or the Broad Agency Announcement Management (BAAM) System. Further information on each system is provided below.

Proposal Preparation and Submission via Research.gov. Research.gov may be used for proposal preparation, submission, proposal file updates, and budgetary revisions. The policy and procedural guidance contained in Part I of the PAPPG pertains to proposals submitted via Research.gov.

Proposal Preparation and Submission in the NSF FastLane System is being decommissioned. During the transition, some parts of FastLane may be left open to support proposal review. Proposal file updates and budget revisions can be made for FastLane-submitted proposals for a limited period.

Proposal Preparation and Submission via Grants.gov. Grants.gov may be used for proposal preparation and submission. The policy and procedural guidance contained in the NSF Grants.gov Application Guide pertains specifically to proposals submitted via Grants.gov. Detailed information about Grants.gov is available from the Grants.gov website .

Proposal Preparation and Submission via NSF’s BAAM System. The BAAM system may be used for proposal preparation, submission, proposal file updates, and some select post-award administrative activities. Detailed information about the BAAM System is available from the BAAM website . The policy and procedural guidance for submitting to NSF’s BAAM System will be provided in the relevant solicitation or in the Broad Agency Announcement (BAA). (See also Section C. below for additional information).

B. NSF Programs and Funding Opportunities

The NSF website provides the most comprehensive source of information on NSF Directorates/Offices (including contact information), programs, and funding opportunities. See Section C below for more information on Categories of Funding Opportunities. Use of this website by potential proposers is strongly encouraged. In addition, " NSF Update " is an information-delivery system designed to keep potential proposers and other interested parties apprised of new NSF funding opportunities and publications, important changes in proposal and award policies and procedures, and upcoming NSF Grants Conferences. Subscribers are informed each time new publications are issued that match their identified interests.

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C. Categories of Funding Opportunities

NSF utilizes a variety of mechanisms to communicate opportunities for research and education support, as well as to generate proposals. A brief description of each category of funding opportunity follows.

1. Program Descriptions

The term "program description" includes broad, general descriptions of programs and activities in NSF Directorates/Offices and Divisions. Program descriptions are posted on Directorate/Division websites to encourage the submission of proposals in specific program areas of interest to NSF.

Program descriptions utilize the generic eligibility and proposal preparation instructions specified in Part I of the PAPPG , as well as the NSB-approved merit review criteria. See Chapter III for additional information.

2. Program Announcements

The term "program announcement" refers to formal NSF publications that announce NSF programs. Program announcements utilize the generic eligibility and proposal preparation guidelines specified in Part I of the PAPPG and incorporate the NSB-approved merit review criteria.

3. Program Solicitations

The term "program solicitation" refers to formal NSF publications that encourage the submission of proposals in specific program areas of interest to NSF. They generally are more focused than program announcements, and normally apply for a limited period of time. Competition among proposals is more precisely defined than with program announcements, and proposals received compete directly with each other for NSF funding. Program solicitations are issued when the funding opportunity has one or more of the following features:

• provides supplemental proposal preparation guidance or deviates from the guidelines established in Part I of the PAPPG;
• contains additional review criteria relevant to the program;
• requires submission of a letter of intent (see Chapter I.D.2) or preliminary proposal (see Chapter I.D.3);
• deviates from (or restricts) the standard categories of proposers specified in Section E. below;
• limits the number of proposals that may be submitted by an organization and/or Principal Investigator (PI) or co-Principal Investigator (co-PI); [3]
• requires cost sharing;
• requires a limitation in indirect (Facilities & Administrative (F&A)) costs;
• specifies additional award conditions and/or reporting requirements; and/or
• anticipates use of a cooperative agreement.

4. Broad Agency Announcements (BAAs)

The term "Broad Agency Announcement" refers to a type of funding opportunity used by NSF for basic and applied research, scientific study, and experimentation. Unless otherwise specified, NSF can choose to fund proposals submitted in response to a BAA as grants, cooperative agreements, contracts, or other arrangements. BAAs are broad in their subject matter and focus on advancing science rather than acquiring specific products. See Federal Acquisition Regulation Part 35.016 for additional information.

5. Dear Colleague Letters (DCLs)

DCLs are intended to provide general information to the community, clarify or amend an existing policy or document, or inform the NSF proposer community about upcoming opportunities or special competitions for supplements to existing awards. They also may be used to announce NSF’s interest in receiving proposals in specified topical areas for the following proposal types contained in Chapter II.E: Planning, Rapid Response Research (RAPID); Early-concept Grants for Exploratory Research (EAGER); Research Advanced by Interdisciplinary Science and Engineering (RAISE); and Conference.

D. Types of Submissions

1. concept outlines.

Some NSF proposal types (see Chapter II.E for additional information) or funding opportunities may require submission of a Concept Outline prior to submission of a full proposal. A Concept Outline is a concise summary of a project idea that contains information about the prospective PI(s), potentially germane NSF organizational unit(s), project title, keywords, and brief narrative descriptions of the idea and fit to any special criteria required for the proposal type or funding opportunity. The primary purposes of requiring a Concept Outline are to ensure that the concept being proposed by the prospective PI is appropriate for the proposal type/funding opportunity, and to help reduce the administrative burden associated with submission of a full proposal. Concept Outlines are considered by cognizant NSF program officers to determine the appropriateness of the work to the proposal type/funding opportunity. The prospective PI will receive an email that specifies whether a full proposal may be submitted. Full proposals submitted without the requisite “Program Officer Concurrence Email” for proposal types/funding opportunities requiring a Concept Outline will be returned without review or not accepted. See Chapter II.E for additional information.

Concept Outlines also may be submitted at any time by prospective PIs seeking early feedback on the general appropriateness and potentially relevant funding opportunities for a project idea prior to developing a full proposal.

Concept Outlines are submitted either by email to a designated address or via the Program Suitability and Proposal Concept Tool ( ProSPCT ). An NSF funding opportunity that requires a Concept Outline will provide directions on use of email or ProSPCT and specific guidance on email formatting or the completion of the webform to facilitate consistent identification and consideration of the respective Concept Outlines.

ProSPCT consists of a dashboard and webform for prospective PIs to prepare, send, and track the status of their Concept Outline submissions. The ProSPCT webform uses drop-down selections, validations, and text entry fields with character count limits to ensure users have provided the minimal complete information and met consistent formatting requirements based on the selected proposal type prior to submitting the Concept Outline. ProSPCT users must have a valid Login.gov account to access the tool.

2. Letters of Intent (LOI)

Some NSF program solicitations require or request submission of an LOI in advance of submission of a full proposal. An LOI is not a binding document. The predominant reason for its use is to help NSF program staff gauge the size and range of the competition, enabling earlier selection and better management of reviewers and panelists. In addition, the information contained in an LOI is used to help avoid potential conflicts of interest in the review process.

An LOI normally contains the PI’s names, a proposed title, a list of possible participating organizations (if applicable), and a synopsis of one page that describes the work in sufficient detail to permit an appropriate selection of reviewers.

Proposers that plan to submit a collaborative proposal from multiple organizations must submit a single LOI for the entire project, given that NSF considers a collaborative proposal to be a unified research project. An LOI is not externally evaluated or used to decide on funding. The requirement to submit an LOI will be identified in the program solicitation, and such letters are submitted electronically to NSF. Failure to submit a required LOI identified in a program solicitation will result in a full proposal not being accepted or returned without review.

3. Preliminary Proposals

Some NSF program solicitations require or request submission of a preliminary proposal in advance of submission of a full proposal. The three predominant reasons for requiring submission of a preliminary proposal are to:

• reduce the proposers' unnecessary effort in proposal preparation when the chance of success is very small. This is particularly true of exploratory initiatives when the community senses that a major new direction is being identified, or competitions that will result in a small number of awards;
• increase the overall quality of the full submission; and
• assist NSF program staff in managing the review process and in the selection of reviewers.

The NSF program solicitation will specify content and submission requirements when preliminary proposals are to be used. Preliminary proposals are prepared by the PI using the Proposal Preparation Module in Research.go v. On the Cover Sheet, the PI clicks on the "Preliminary Proposal" check box. The PI completes only the sections appropriate to the preliminary proposal. The PI then forwards the proposal to the appropriate office at the proposing organization, and the Authorized Organizational Representative (AOR) signs and submits the preliminary proposal via use of NSF’s electronic systems.

One of the following two types of decisions may be received from NSF upon submission of a preliminary proposal. The program solicitation will specify the type of decision to be rendered for a particular program.

a. Invite/Not Invite Decisions

This type of mechanism is used when the NSF decision made on the preliminary proposal is final, affecting the organization’s eligibility to submit a full proposal. Only submitters of favorably reviewed preliminary proposals are invited and eligible to submit full proposals. The PI and the organization's Sponsored Projects Office (SPO) (or equivalent) will be electronically notified of NSF's decision to either invite submission of a full proposal or decline NSF support.

b. Encourage/Discourage Decisions

This type of mechanism is used when the NSF decision made on the preliminary proposal is advisory only. This means that submitters of both favorably and unfavorably reviewed preliminary proposals are eligible to submit full proposals. The PI and the organization's SPO will be notified of NSF's decision to either encourage or discourage submission of a full proposal.

4. Full Proposals

The full proposal should present the (1) objectives and scientific, engineering, or educational significance of the proposed work; (2) suitability of the methods to be employed; (3) qualifications of the investigator and the recipient organization; (4) effect of the activity on the infrastructure of science, engineering, and education, if applicable; and (5) amount of funding required. It should present the intellectual merit and broader impacts of the proposed project clearly and should be prepared with the care and thoroughness of a paper submitted for publication. The requisite proposal preparation instructions are contained in Chapter II. Sufficient information should be provided to enable reviewers to evaluate the proposal in accordance with the two merit review criteria established by the NSB. (See Chapter III for additional information on NSF processing and review of proposals.)

NSF expects strict adherence to the rules of proper scholarship and attribution. The responsibility for proper scholarship and attribution rests with the authors of a proposal; all parts of the proposal should be prepared with equal care for this concern. Authors other than the PI (or any co-PI) must be named and acknowledged. Serious failure to adhere to such standards can result in findings of research misconduct. Research misconduct refers to fabrication, falsification, or plagiarism in proposing or performing research funded by NSF, reviewing research proposals submitted to NSF, or in reporting research results funded by NSF. Reporting results include but is not limited to: annual/final project reports and Project Outcomes Reports submitted to NSF, as well as the publication of results from the NSF-funded projects. NSF policies and rules on research misconduct are discussed in the Chapter XII.C, as well as 45 CFR Part 689.

NSF will not tolerate research misconduct. Allegations of research misconduct are taken seriously and are investigated by NSF’s Office of Inspector General (OIG). OIG refers completed investigations of research misconduct to NSF for action. Upon findings of research misconduct, NSF will take appropriate action against individuals or organizations.

The Metric Conversion Act of 1975, as amended, and E.O. 12770 of 1991 encourage Federal agencies to use the Metric System (SI) in procurement, award and other business-related activities. Proposers are encouraged to use the Metric System of weights and measures in proposals submitted to the Foundation. Recipients also are encouraged to use metric units in reports, publications and correspondence relating to proposals and awards.

E. Who May Submit Proposals

NSF welcomes proposals on behalf of all qualified scientists, engineers, and educators. The Foundation strongly encourages women, minorities, and persons with disabilities to participate fully in its programs. In accordance with Federal statutes, regulations and NSF policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any program or activity receiving financial assistance from NSF, although some programs may have special requirements that limit eligibility.

Scientists, engineers, and educators usually initiate proposals that are officially submitted by their employing organization. Before formal submission, the proposal may be discussed with appropriate NSF program staff. Graduate students are not encouraged to submit research proposals but should arrange to serve as research assistants to faculty members. Some NSF divisions accept proposals for Doctoral Dissertation Research Grants when submitted by a faculty member on behalf of the graduate student.

Categories of Proposers — The following describes the eligibility of specific categories of proposers. A program solicitation, however, may apply more restrictive eligibility criteria.

1. The following organizations in the following categories are eligible to submit proposals:

(a) Institutions of Higher Education (IHEs) — Two- and four-year IHEs (including community colleges) accredited in, and having a campus located in the U.S., acting on behalf of their faculty members. IHEs located outside the U.S. fall under paragraph 6. below.

Special Instructions for International Branch Campuses of U.S. IHEs

If the proposal includes funding to be provided to an international branch campus of a U.S. IHE (including through use of subawards and consultant arrangements), the proposer must explain the benefit(s) to the project of performance at the international branch campus and justify why the project activities cannot be performed at the U.S. campus. Such information must be included in the project description. The box for “Funding of an International Branch Campus of a U.S. IHE” must be checked on the Cover Sheet if the proposal includes funding for an international branch campus of a U.S. IHE.

(b) Non-profit, Non-academic Organizations — Independent museums, observatories, research laboratories, professional societies, and similar organizations located in the U.S. that are directly associated with educational or research activities.

(c) Tribal Governments — The term " tribal government means the governing body of any Indian or Alaska Native tribe, band, nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian tribe under the Federally Recognized Indian Tribe List Act of 1994 ( 25 U.S.C. 479a , et seq.)

2. The following organizations may be eligible to submit proposals:

(a) For-profit Organizations — U.S.-based commercial organizations, including small businesses, with strong capabilities in scientific or engineering research or education and a passion for innovation. An unsolicited proposal from a for-profit organization may be funded when the project is of special concern from a national point of view, special resources are available for the work, or the proposed project is especially meritorious. NSF is interested in supporting projects that couple industrial use-inspired challenges and research resources with those of IHEs; therefore, the Foundation especially welcomes proposals for cooperative projects involving both IHEs and industry. Specific NSF funding opportunities also may make For-Profit Organizations eligible for submission of proposals to the Foundation. US-based affiliates or subsidiaries of foreign organizations must contact the cognizant NSF program officer prior to preparing and submitting a proposal to NSF.

(b) State and Local Governments — As programmatically necessary and as provided for in a solicitation or BAA, State, and local governments may be eligible to submit proposals.

(c) Foreign Organizations — NSF rarely provides direct funding support to foreign organizations. NSF will consider proposals for cooperative projects involving U.S. and foreign organizations, provided support is requested only for the U.S. portion of the collaborative effort.

In cases however, where the proposer considers the foreign organization or foreign individual’s involvement to be essential to the project and proposes to provide funding through the NSF budget (through a subaward or consultant arrangement), the proposer must explain why support from the foreign counterpart’s in-country resources is not feasible and why the foreign organization or foreign individual can carry out the activity more effectively than a U.S. organization or U.S. individual. In addition, the proposed activity must demonstrate how one or more of the following conditions have been met:

• The foreign organization or foreign individual contributes unique expertise, organizational capability, facilities, data resources, and/or access to a geographic location not generally available to U.S. investigators (or which would require significant effort or time to duplicate); and/or
• The foreign organization or foreign individual offers significant science and engineering education, training, or research opportunities to the U.S.

Such information must be included in any proposal to NSF, including new and renewal proposals. The information must be included in the project description section of the proposal. The box for "Funding of a Foreign Organization or Foreign Individual" must be checked on the Cover Sheet if the proposal includes funding for a foreign organization or foreign individual.

(d) Other Federal Agencies — NSF does not normally support research or education activities by scientists, engineers or educators employed by Federal agencies or FFRDCs. Under unusual circumstances, other Federal agencies and FFRDCs may submit proposals directly to NSF. A proposed project is only eligible for support if it meets one or more of the following exceptions, as determined by a cognizant NSF Program Officer in advance of proposal submission:

• Special Projects. Under exceptional circumstances, research, or education projects at other Federal agencies or FFRDCs that can make unique contributions to the needs of researchers elsewhere or to other specific NSF objectives may receive NSF support.
• National and International Programs. The Foundation may fund research and logistical support activities of other Government agencies or FFRDCs directed at meeting the goals of special national and international research programs for which the Foundation bears special responsibility, such as the U.S. Antarctic Research Program.
• International Travel Awards. To help ensure appropriate representation or availability of a particular expertise at an international conference, staff researchers of other Federal agencies may receive NSF international travel awards.

Proposers who think their project may meet one of the exceptions listed above must contact a cognizant NSF Program Officer before preparing a proposal for submission. In addition, a scientist, engineer or educator who has a joint appointment with an IHE and a Federal agency (such as a Veterans Administration Hospital, or with an IHE and a FFRDC) may submit proposals through the IHE and may receive support if the individual is a faculty member (or equivalent) of the IHE, although part of the individual’s salary may be provided by the Federal agency. Preliminary inquiry must be made to the appropriate program before preparing a proposal for submission.

3. Unaffiliated individuals

Unaffiliated individuals in the U.S. and unaffiliated U.S. citizens are not eligible to receive direct funding support from NSF. Recipients of Federal funds must be able to demonstrate their ability to fully comply with the requirements specified in 2 CFR §200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. As such, unaffiliated individuals are strongly encouraged to affiliate with an organization that is able to meet the requirements specified in 2 CFR §200.

An individual submitting a proposal to an NSF Postdoctoral Fellowship solicitation is not considered an unaffiliated individual.

F. When to Submit Proposals

Proposers should allow adequate time for processing of proposals (see Chapter I.H for further information). Many NSF programs accept proposals at any time. Other programs, however, establish due dates for submission of proposals. The following types of due dates are utilized by NSF:

1. Target Dates : dates after which proposals will still be accepted, although they may miss a particular panel or committee meeting.

2. Deadline Dates : dates after which proposals will not be accepted or will be returned without review by NSF. The deadline date will be waived only in extenuating circumstances. Such a deviation may be authorized only in accordance with Chapter II.A.

3. Submission Windows : designated periods of time during which proposals will be accepted for review by NSF. It is NSF’s policy that the end date of a submission window converts to, and is subject to, the same policies as a deadline date.

These target dates, deadlines, and submission windows are published in specific program descriptions, program announcements and solicitations that can be obtained through the NSF website. [4] Unless otherwise stated in a program announcement or solicitation, proposals must be received by the specified date. If the deadline date falls on a weekend, it will be extended to the following Monday; if the date falls on a Federal holiday, it will be extended to the following business day. Proposals must be received by 5 p.m. submitter's local time on the established deadline date. Failure to submit by 5.p.m. submitter’s local time will result in the proposal not being accepted. See Chapter IV.B for additional information. Letters of intent or preliminary proposals also follow the 5 p.m. submitter's local time standard.

Special Exceptions to NSF’s Deadline Date Policy

In the occurrence of a natural or anthropogenic event, or when NSF is closed due to inclement weather or other reason that interferes with an organization’s ability to meet a proposal submission deadline, NSF has developed the following guidelines for use by impacted organizations.

Natural or Anthropogenic Event - Flexibility in meeting announced deadline dates because of a natural or anthropogenic event that impacts a proposer’s ability to submit a proposal to NSF may be granted with the approval of the cognizant NSF Program Officer. Where possible, such requests should be submitted in advance of the proposal deadline. Proposers should contact the cognizant NSF Program Officer in the Division/Office to which they intend to submit their proposal and request authorization to submit a proposal after the deadline date. Proposers must then follow the written or verbal guidance provided by the cognizant NSF Program Officer. The Foundation will work with each impacted organization on a case-by-case basis to address its specific issue(s). Generally, NSF permits extension of the deadline by up to five business days.

To submit the proposal after the deadline date, proposers must check the “Special Exception to the Deadline Date Policy” box on the NSF Cover Sheet, indicating NSF approval has been obtained. A statement identifying the nature of the event that impacted the ability to submit the proposal on time must be uploaded under Nature of Natural or Anthropogenic Event in the Single Copy Document section in Research.gov. If available, written approval from the cognizant NSF Program Officer also should be uploaded under the Additional Single Copy Documents in the Single Copy Document section in Research.gov.

Closure of NSF – When NSF is closed due to inclement weather or other reason [5] , deadline(s) that occurred during the closure automatically will be extended to the following business day after the closure ends.

G. How to Submit Proposals

1. submission instructions.

The same work/proposal cannot be funded twice. If the proposer envisions review by multiple programs, more than one program may be designated on the Cover Sheet. The submission of duplicate or substantially similar proposals concurrently for review by more than one program will result in the return of the redundant proposals. (See Chapter IV.B.)

In submission of a proposal for funding, the AOR is required to provide certain NSF-specific proposal certifications. (See Chapter II.C.1.d for a listing.) This certification process will occur concurrently with submission of the proposal. Submission of government-wide representations and certifications is addressed in Chapter I.G.2 below.

2. Requirements Relating to Unique Entity Identifier (UEI) and Registration in the System for Award Management (SAM)

All proposers must provide a UEI when applying for a new or renewal award. NSF requires that organizations registering to use NSF's electronic systems have a valid and active SAM registration and have a valid UEI. NSF will validate that each proposer's UEI and SAM registration are active and valid prior to allowing submission of a proposal to NSF. If a registration is not active, an organization will not be able to submit a proposal. Additionally, if the registration is not revalidated annually and is not valid, NSF will block any award approval actions. Organizations are responsible for maintaining their SAM registration and UEI information.

Any subrecipients named in the proposal also are required to obtain a UEI and register in Research.gov. Subrecipients named in the proposal, however, do not need to be registered in SAM. GSA has implemented a process by which an organization that will only be a subrecipient may receive a UEI without undergoing a complete SAM registration. See the SAM.gov website for additional information about registration and UEI assignment.

SAM is the primary registrant database for the U.S. Government. SAM collects, validates, stores, and disseminates data in support of agency acquisition missions, including Federal agency contract and Federal financial assistance awards. This SAM registration must be maintained with current information at all times during which an organization has an active award or a proposal under consideration by NSF. Failure to comply with SAM registration requirement prior to proposal submission may impact the processing of the proposal. Proposers are advised that entity registration will become active after three to five business days when the Internal Revenue Service (IRS) validates the Tax ID Number.

Organizations are responsible for maintaining the accuracy of their information in SAM and utilizing SAM to submit government-wide representations and certifications. Prior to proposal submission, all proposing organizations are required to have reviewed and certified compliance with the government-wide financial assistance representations and certifications maintained in SAM. Failure to comply with SAM certification and registration requirements will impact the submission and processing of the proposal. If a registration is not active, an organization will not be able to submit a proposal, nor will NSF be able to take approval actions on any submitted proposals or recommended awards. Additionally, payments will not be able to be processed and approved.

Organizations also are responsible for updating all SAM registration information as it changes. Once an award is made, failure to maintain current and complete information within SAM will impact receipt of funding. To maintain an active status in SAM, an organization's registration must be renewed and revalidated at least every 12 months from the date of the previous registration, including recertification of the government-wide financial assistance representations and certifications. If the registration is not renewed, it will expire. An expired registration will impact an organization's ability to submit proposals and/or receive award payments. Note that if an organization's registration lapses, it will take longer to reactivate the registration than if the registration is still active when doing the revalidation and recertification.

SAM is the NSF system of record for organizational information, including financial and address information. The Legal Business Name and Physical Address information are automatically pulled from SAM and used by NSF to validate organizational information. All name and address changes must be handled via SAM. NSF has no control over SAM and cannot override SAM data or statuses.

The NSF ID is a unique numerical identifier assigned to users by NSF. The NSF ID is used throughout NSF's electronic systems as a login ID and identification verification. Each individual user of NSF systems, (e.g., Research.gov) should not have more than one NSF ID. Users with more than one NSF ID should contact the Help Desk at 1-800-381-1532 or by e-mail to [email protected] for assistance.

Submission of Social Security Numbers (SSNs) only will be requested where it is necessary for business purposes, e.g., financial reimbursement. An SSN is solicited under the NSF Act of 1950, as amended.

4. Proposal Receipt

Once the proposal is submitted, PIs can check the status of the proposal via use of NSF's electronic systems. If a proposal number is not reflected in the electronic systems, contact the Help Desk at 1-800-381-1532 or by e-mail to [email protected] .

Communications about the proposal should be addressed to the cognizant NSF Program Officer with reference to the proposal number. Proposers are strongly encouraged to use NSF's electronic systems to verify the status of their submission to NSF.

H. Proposal Processing

Proposers should allow up to six months for programmatic review and processing (see Chapter III for additional information on the NSF merit review process). In addition, proposers should be aware that the NSF Division of Grants and Agreements generally makes awards within 30 calendar days after the program division/office makes its recommendation. Grants and cooperative agreements that are being made to organizations that have not received an NSF award within the preceding five years or involving special situations (such as coordination with another Federal agency or a private funding source), cooperative agreements, and other unusual arrangements may require additional review and processing time. Proposals that are time-sensitive (e.g., conference and group travel) will be accepted for review only if, in the opinion of the cognizant Program Officer, they are received in sufficient time to permit appropriate NSF review and processing to support an award in advance of the activity to be supported. Every effort is made to reach a decision and inform the proposer promptly. Until an award is made, NSF is not responsible for any costs incurred by the proposing organization.

Footnotes to Chapter I

[3] Unless otherwise specified, the term "organization" refers to all categories of proposers.

[4] A listing of upcoming target dates and deadlines, sorted by date and by program area is available on the NSF website.

[5] This policy is not intended to cover NSF closures due to lapses in appropriation. In such cases, specific guidance will be issued, as appropriate.

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Legislative Review of the Cannabis Act : Final Report of the Expert Panel

Download in PDF format (1.324 KB, 97 pages)

Organization: Health Canada

Date published: March 2024 Cat.: H134-37/2024E-PDF ISBN: 978-0-660-70615-3 Pub.: 230837

Prepared by:

Morris Rosenberg (Chair) Dr. Oyedeji Ayonrinde Dr. Patricia J. Conrod Lynda L. Levesque Dr. Peter Selby

Table of contents

Chapter 1: executive summary, chapter 2: recommendations and observations, chapter 3: introduction, chapter 4: summary of engagement, chapter 5: overview of the cannabis framework, chapter 6: public health.

Chapter 7: First Nations, Inuit and Métis

Chapter 8: Economic, social and environmental impacts

Chapter 9: adult access, chapter 10: criminal activity and displacement of the illicit market, chapter 11: medical access, chapter 12: research and surveillance, appendix a: glossary, appendix b: stakeholder list, appendix c: panel member biographies.

After almost a century of prohibition, Canada became the first major developed country to legalize and regulate cannabis when the Cannabis Act (the Act) came into force in 2018. Canada's approach to cannabis shifted from prohibiting and criminalizing activities with cannabis to one grounded in regulated and controlled access to minimize the risks and harms for individuals and communities.

In view of the wide-ranging impacts of the change from prohibition to legal, regulated access, Parliament established a requirement for the Act to be reviewed 3 years after its coming into force.

In September 2022, the Minister of Health and the Minister of Mental Health and Addictions and Associate Minister of Health appointed us as an independent Expert Panel to conduct a review. The mandate for the review, set out in section 151.1 of the Act, was to assess the administration and operation of the legislation, particularly:

• impact of the Act on public health and, in particular, on the health and consumption habits of young persons with respect to cannabis use
• impact of cannabis on Indigenous persons and communities
• impact of the cultivation of cannabis plants in a dwelling-house

The Ministers also asked us to consider the following:

• economic, social and environmental impacts of the Act
• progress towards providing adults with access to strictly regulated, lower-risk, legal cannabis products
• progress made in deterring criminal activity and displacing the illicit cannabis market
• impact of legalization and regulation on access to cannabis for medical purposes
• impacts on Indigenous Peoples, racialized communities and women, who might be at greater risk of harm or face greater barriers to participation in the legal industry based on identity or socio-economic factors

We were supported by the Legislative Review Secretariat, housed in Health Canada, whose role was to provide administrative and research support. We would like to thank the team for their invaluable assistance through this process.

Engagement process

We were provided with a report from Health Canada summarizing information and stakeholder perspectives it had collected in the lead up to the review. This report was published on Health Canada's website along with an invitation to submit written comments. With the help of the Secretariat, we developed a comprehensive engagement strategy to allow experts and people with relevant lived and living experience to provide more detailed guidance on particular topics and to answer specific questions. We held nearly 140 engagement sessions and heard from over 600 participants. We employed a distinctions-based approach for our engagement with First Nations, Inuit and Métis. Footnote 1

Principles and approach

Consistent with the purpose of the legislation, as stated in section 7 of the Act, we kept the protection of public health and public safety at the forefront of our review.

We took an evidence-informed approach, incorporating research findings, statistics and data, as well as the insights shared with us by stakeholders, experts, and those with lived and living experience. We applied a Sex and Gender-based Analysis Plus (SGBA Plus) lens in our work, recognizing that policies can have varying impacts on different subpopulations and communities. Footnote 2

It has only been 5 years since the Act came into force. It has been difficult to fully assess the impacts of legalization, given the limited time to collect data and evaluate outcomes and ongoing barriers to research. Despite these caveats, we aimed to identify dominant trends and themes, while also exercising caution when the evidence was not able to support a recommendation.

Based on the evidence presented to us, we believe that there has been significant progress made on several of the key objectives of the legislation. Notably, these include:

• the establishment of a licensing framework supporting a legal industry that is providing adult consumers with a quality-controlled supply of a variety of cannabis products
• steady progress in shifting adult consumers to the legal cannabis market
• for the most part, adherence to rules on promotion, packaging and labelling, including prohibitions about making claims about health or lifestyle benefits
• a significant reduction (95% between 2017 and 2022) in the number of charges for the possession of cannabis and minimizing the negative impact on some individuals from interactions with the criminal justice system

However, it would be a mistake for governments to adopt an attitude of complacency with the current regime or move away from a public health and public safety approach to cannabis. Continuous assessment of what works and what needs to change is necessary in a framework that is a radical shift from an era of prohibition, which limited research and evidence-based policy. Our consultations have uncovered the following areas of concern.

Youth and children

We are concerned with trends related to youth use of cannabis. While the data indicates that youth use has remained relatively stable since legalization, Canada continues to report among the highest rates of youth cannabis use in the world, and cannabis use among young adults has increased (for example, as described in our What We Heard Report , surveys now suggest that more than 4 in 10 Canadians aged between 20 and 24 report using cannabis in the past year). We find that the inadequate support for some interventions, particularly youth prevention initiatives, has contributed to this trend. Further, increasing reports of poisonings among children who have unintentionally consumed cannabis are troubling.

High-potency products

We are also increasingly concerned with the apparent shift toward the consumption of higher-potency cannabis products, since these products carry greater health risks, and there have been recent reports suggesting increases in cannabis-related health care presentations.

First Nations, Inuit and Métis communities

We acknowledge the barriers and challenges First Nations, Inuit and Métis communities have experienced with respect to the cannabis framework. We have heard consistently that First Nations, Inuit and Métis were not adequately consulted when the Act and related measures were developed. This has led to significant public health and public safety challenges in many communities and inequitable economic development opportunities. There is an urgent need to re-engage on these issues consistent with the Government of Canada's commitment to recognize the rights of Indigenous Peoples, and with a shared commitment by all parties to protecting public health and public safety.

Industry challenges

The legal cannabis industry has made substantial progress in shifting adult consumers to the legal cannabis market, although progress has been uneven across the country. The illicit cannabis market remains entrenched, and too many illicit retailers continue to operate both online and physical stores.

There are challenges for the sustainability of companies, particularly smaller-sized licensed cultivators and processors.

Industry representatives expressed concerns about the cost burden that the excise tax imposes on them, particularly the excise tax for dried cannabis, as well as the costs associated with regulatory fees and regulatory requirements that are imposed at both the federal and provincial and territorial levels.

The information available to us also suggests a lack of diversity in the sector, and that communities that were disproportionately harmed when cannabis was criminalized continue to face barriers to participation in the legal market.

Reduced interactions with the criminal justice system

We are encouraged by the significant decrease in Canadians' interactions with the criminal justice system related to cannabis; however, there is a need for more data on the extent to which racial bias continues to exist in law enforcement activities related to cannabis.

Need for more enforcement

While the Act contains serious offences and penalties to deter criminal activities with cannabis (such as unauthorized production and sale to youth), enforcement action has been limited due to shifting police priorities, inadequate resourcing and gaps in authority. A greater commitment to enforcement is needed to avoid undermining the integrity of the regime. Inadequate enforcement emboldens criminal actors and may be interpreted by some that illicit cannabis activity does not pose health or safety concerns.

Access to cannabis for medical purposes

The legalization of cannabis did not substantially facilitate research and there has been limited progress on evaluating the therapeutic benefits of cannabis. Patients continue to report many challenges obtaining reasonable access to cannabis for medical purposes, as well as difficulties finding reliable information, specific products, and supportive and knowledgeable health care professionals. The current lack of high-quality evidence can create difficulties for health care professionals and insurance providers faced with patient requests about the use of cannabis for medical purposes. Our consultations have helped us to identify several promising reforms to improve how patients access cannabis for medical purposes.

Filling research gaps

Deficiencies in the evidence available impeded our ability to fully assess the impacts of legalization on public health and public safety. To address critical knowledge gaps, sustained investment in surveillance and research in a range of disciplines will be required.

Nature of our advice

Achieving the public health and public safety objectives of the Act requires a multi-faceted approach relying on several policy instruments. Most of our recommendations involve targeted changes to policies and regulations, and bolstering support for research, surveillance and enforcement. We also propose new initiatives related to prevention and enhanced consumer information.

We have limited our formal recommendations to areas within the mandate of the Government of Canada. However, given that responsibilities in some areas of cannabis control rest with other levels of government and that other actors play important roles (such as law enforcement and health care professionals), we have made some observations in areas outside the purview of the federal government.

Moving forward, it will be important for the Government of Canada to allocate appropriate funding and resources to ensure the effective implementation of the cannabis framework. This will need to include allocating resources in areas that did not initially receive dedicated funding, such as research on the therapeutic potential of cannabis and prevention and treatment programming. In some circumstances difficult decisions will need to be made about when, or the extent to which, our recommendations can be implemented. While some new investments may be required, we encourage all levels of government to consider how existing resources can be redirected, and to consider how cannabis fits into broader priorities (for example, investment in mental health and addictions services, prevention programs, consumer information, and research and surveillance).

Summary of advice

Public health: youth.

Youth and young adults are more vulnerable to the adverse effects of cannabis. More needs to be done to drive change in youth behaviour to reduce prevalence of use and discourage harmful use. There may be lessons from the success in reducing youth use of other substances, such as tobacco, that can be applied to cannabis. Greater efforts towards increasing evidence-based prevention programs, and monitoring and enforcing laws against promotion and the sale of cannabis to young people, could help to address this concern.

Public health: Children

Increasing reports of poisonings among children who have unintentionally consumed cannabis, notably edible cannabis, were troubling. Children should never be able to access cannabis and these exposures should never occur. More research is needed to understand what products are involved in these incidents, as well as renewed efforts to educate consumers, including parents and caregivers, about ways to prevent these poisonings.

Public health: Adults

For adult consumers, we are concerned about the emerging shift toward increasingly potent cannabis products in the legal market (that is, products with high quantities or concentrations of delta-9-tetrahydrocannabinol [THC]), and recent studies suggesting increases in health care presentations, including for psychosis.

A mix of policy instruments should be used to mitigate the risks posed by higher-potency and novel cannabis products, including better research, making a wider variety of lower-potency products available to consumers, enhancing information for consumers, and ongoing regulatory compliance and enforcement efforts by Health Canada. If the current trend toward higher-potency cannabis cannot be halted or reversed, then Health Canada should be ready to restrict or prohibit certain products to protect Canadians from the associated harms. To be effective, such regulatory measures should be accompanied by strategies to prevent the illicit market from taking over this market segment.

Maintenance of public health measures

The evidence suggests that the framework includes appropriate controls and measures to manage the risks associated with the exposure to and consumption of cannabis, while providing adults who choose to use cannabis with access to a wide variety of quality-controlled products. That said, there are areas where implementation can be improved and where more effort is needed. This is particularly true of efforts to reduce the consumption of products with higher quantities or concentrations of THC.

After reviewing available evidence and the core health and safety-focused rules, we recommend that the majority should be maintained (including restricting promotion to environments where it is not visible to youth, requiring plain packaging and prohibiting products that are appealing to youth). That said, there are areas where greater clarity can be provided to industry about permissible promotion, packaging and labelling practices, and areas where certain changes could be made that would not impact the protection of public health.

Many First Nations, Inuit and Métis communities reported challenges in providing services for their people related to cannabis, given the many priorities they must address with limited resources. We recommend support for distinctions-based health, public health and mental health initiatives in communities, as well as support for evidence-based materials and programs to disseminate distinctions-based cannabis-related health information.

While the Act defines the authorities of the federal government and provincial and territorial governments, it is silent on the authority of First Nations, Inuit and Métis governments with respect to cannabis. This is a significant gap that negatively impacts the public health, public safety and equitable treatment of Indigenous communities and individuals seeking to participate in the cannabis industry.

We acknowledge the Government of Canada's commitment to align Canada's laws with the United Nations Declaration on the Rights of Indigenous Peoples through the United Nations Declaration on the Rights of Indigenous Peoples Act . However, given the uncertainties respecting the timelines and ways the Declaration will be implemented, and the public health and public safety challenges that are present in Indigenous communities, more immediate changes are necessary.

We call for amendments to the Cannabis Act , facilitating a collaborative process with Indigenous communities that would allow those who wish to exert more control over cannabis-related activities in their territories to enter into nation-to-nation agreements with the Government of Canada based on agreed-upon minimum standards to protect public health and public safety. We also recommend that Health Canada, as well as provinces and territories, take steps to improve their licensing processes to better support Indigenous applicants who wish to participate in the legal cannabis market.

Economic, social and environmental impacts

Industry representatives raised urgent concerns about their financial viability in the highly competitive market that exists today. These concerns are well-founded; however, any efforts to support the industry must be consistent with the public health and public safety objectives of the Act and not aim to increase the amount of cannabis consumed or the number of Canadians who use cannabis.

The Government of Canada should support continued displacement of the illicit market, while maintaining measures that protect public health and public safety. Continued monitoring of the legal share of the total market, relying on a combination of information sources that are sensitive to emerging trends, will be important to guide policymaking and priority-setting across all levels of government.

Health Canada should reduce the financial and administrative burden it places on participants in the legal industry. We recommend Health Canada accelerate its work to reduce unnecessary regulatory burden, informed by the experience gained over the last 5 years. It appears there is room to revise certain regulatory requirements without compromising public health or public safety.

Industry players have repeatedly called on the Government of Canada to reform the excise tax regime, particularly for dried cannabis where price decreases have substantially increased the tax burden for industry. We recognize that Finance Canada has committed to monitoring this issue, but we see an opportunity to update tax policy to reflect the current reality and to encourage positive changes in cannabis use behaviour by developing a progressive excise tax regime. This would involve higher-potency products being subject to more tax than lower-potency products.

At the outset of legalization, there was a missed opportunity to address the harms of prohibition. The Government of Canada has a role to play in encouraging the participation of marginalized and racialized groups in the industry, and to support inclusivity and remove barriers to success. Health Canada and its partners should take a comprehensive approach that looks beyond the issuance of a licence, to include pre- and post-licensing supports, and take a broad view of diversity so that policies and programs consider how to support the inclusion of smaller-sized businesses across the country.

We would like to see substantial improvements in the state of knowledge about the differential impacts of legalization on equity-deserving groups, as well as measures taken to address identified issues.

Adult access

The available information indicates that access to legal cannabis has improved since the Act came into force in October 2018. It appears that most adult Canadians who wish to obtain cannabis can do so from legal sources. However, we observed some geographical differences in ease of access, notably in the North.

One of the issues we heard most about was the amount of THC permitted in edible cannabis products. While industry stakeholders favoured increasing the limit to encourage consumers to shift to the legal market, public health stakeholders opposed this, citing concerns about the potential impact on child poisonings, cannabis-related emergency room visits and mental health impacts. Given these concerns, we believe Health Canada should maintain the current limit of 10 milligrams of THC per package in edible cannabis products and continue to develop the knowledge base in this area to determine whether there are conditions under which the limit could be raised without unduly impacting public health.

Criminal activity and displacement of the illicit market

Consumers who wish to access legal, regulated cannabis can do so, and we are encouraged by the evidence we have seen on the transition of adult consumers to the legal cannabis market, but more needs to be done.

We are also encouraged that legal access has reduced some of the negative social impacts on individuals, especially in terms of interactions with the justice system for the possession of cannabis.

However, we are concerned with the criminal activity that persists outside of the legal framework. The illicit production and sale of cannabis poses dangers to public safety (for example, illicit cannabis sales support other activities of organized crime, such as money laundering and possession of firearms) and to public health (for example, illicit products can carry greater risks than those available in the legal market because of inaccurately labelled cannabinoid content and the presence of contaminants).

We are also struck by the limited enforcement action. We appreciate that law enforcement does not have unlimited resources to address criminal activity and must prioritize; however, the integrity of the regime depends on deterring criminal activity and effective enforcement. Notwithstanding other priorities, we encourage law enforcement to focus their efforts on the involvement of organized crime, the diversion of cannabis from personal and designated production sites (where individuals register with Health Canada to produce their own cannabis for medical purposes), the proliferation of unauthorized retail stores on First Nations reserves (that is, stores that operate without approval from community leadership, or a provincial or territorial authorization) and the activities of illicit online sellers (who promote and sell with relative ease to youth and adults).

We also believe that the burden of enforcement should not fall entirely on the police. Health Canada, Public Safety Canada, provincial and territorial regulators and the Canadian public have a role to play in deterring illegal activity. There needs to be more collaboration between regulators and police forces to develop a comprehensive strategy to address illicit activity. Canadians also need information about the broader social harms they unintentionally encourage when they purchase from the illicit market.

Medical access

The legalization of cannabis has had a profound impact on how Canadians access cannabis. However, patients, health care professionals, medical regulatory bodies, municipalities and law enforcement have all voiced concerns about how the system of access to cannabis for medical purposes is working. Many patients are concerned that they do not have reasonable access to cannabis for medical purposes from licensed sellers, while health care professionals and medical regulatory bodies continue to have concerns about the lack of evidence to guide clinical decisions. Municipalities and law enforcement have serious concerns about the abuse of the personal and designated production program, and how cannabis is diverted from this program into the illicit market. We heard that some health care professionals authorizing cannabis for medical purposes accept financial incentives from industry, a practice that would be considered unacceptable in the context of prescription medications.

We see a need to maintain a distinct medical access program, with improvements, to better support patients and to better address the problems caused by bad actors in the personal and designated production program.

We appreciate that there are still significant gaps in the evidence base and recognize that cannabis is not a suitable treatment for all individuals and all health conditions, nor is its use risk-free. At the same time, there is a need to continue to support patients to access cannabis for medical purposes. Clinical guidance is required to increase the knowledge and understanding of health care professionals related to cannabis for medical purposes.

In our view, an important improvement to the medical access regime would be the establishment of an in-person pharmacy access channel. We recognize that establishing a pharmacy access channel cannot happen overnight. It would require regulatory changes from Health Canada and consultation with interested provinces and territories and regulatory authorities for pharmacists. Pharmacy access would have benefits for patients by addressing concerns about delays with mail delivery and product shortages and would allow patients to consult with a pharmacist and discuss potential drug interactions or side effects.

We recognize that Health Canada has made progress in reducing the number of registrations in the personal and designated production program, and the number of plants grown under these registrations. We encourage the department to continue to carefully scrutinize applications and to refuse or revoke those that pose risks to public health and public safety. Limiting the ability of multiple individuals to grow plants at the same site would also reduce the risks associated with this program.

Research and surveillance

Five years after the legalization of cannabis, many critical knowledge gaps remain. Priorities must be set to guide investments in research, helping to fill gaps in the evidence base and guide future policy decisions. We encourage this priority-setting to be done quickly, and for the necessary funding to be made available to support this research.

In addition to research to fill knowledge gaps, there must be continued surveillance of cannabis-related behaviours and cannabis-related health effects.

Looking ahead

Our review fulfills the requirement in section 151.1 of the Act, but the Act refers only to a single review. We believe there should be similar reviews at regular intervals to ensure the impacts of the framework are assessed over time. While mandated reviews of the Act would provide important opportunities to take stock, we also encourage federal, provincial and territorial governments to evaluate their frameworks, including laws, regulations, policies, programs and interventions, on an ongoing basis.

Recommendations

Recommendation 1: The Government of Canada should allocate sufficient funding and resources to ensure the effective implementation of the cannabis framework, including the ability to address emerging public health and public safety issues.

Public health

Recommendation 2: Health Canada should set and monitor targets for reducing youth and young adult cannabis use and cannabis-related harms.

Recommendation 3: Health Canada should redouble its efforts to inform Canadians about the potential risks to children that can arise from accidental exposure to cannabis products (irrespective of the product's origin) and provide advice to consumers on where and how to store cannabis safely.

Recommendation 4: Health Canada should take a leadership role, working in collaboration with provinces and territories, to support the development and implementation of evidence-based school prevention programs and other interventions to reduce the prevalence of youth cannabis use. Federal, provincial and territorial governments should consider committing a portion of cannabis revenues to fund evidence-based public health interventions, including prevention programming for youth and young adults.

Recommendation 5: Health Canada should establish a representative youth advisory board on cannabis to provide a mechanism to engage with youth and young adults on cannabis and related issues. This forum should allow young Canadians to share their knowledge, insights and feedback on cannabis policy, regulatory initiatives and non-regulatory programs that would affect them and their peers.

Recommendation 6: Health Canada should take steps to mitigate the risks associated with cannabis products that contain higher quantities or concentrations of delta-9-tetrahydrocannabinol (THC), including working to establish a definition of higher-potency cannabis products and applying additional health warnings that inform consumers about the elevated risks of these products. We offer a separate recommendation on the use of tax policy to disincentivize the consumption of higher-potency cannabis products. If the current trend towards consuming higher-potency cannabis cannot be halted or reversed, then Health Canada should be ready to implement additional product regulations. To be effective, such regulatory measures should be accompanied by strategies to prevent the illicit market from occupying this market segment.

Recommendation 7: Health Canada should maintain key promotion and plain packaging and labelling requirements, including restrictions on characteristics that are appealing to youth, child-resistant packaging and limits on the use of logos, colours and branding, that are aimed at protecting children and youth, and prohibitions on promotions that imply wellness or lifestyle enhancement.

Recommendation 8: Health Canada should ensure the cannabis industry is provided with clear guidance on the promotion restrictions and packaging and labelling requirements, including correcting misperceptions about what information is, and is not, allowed on product labels (or in cannabis promotions).

Recommendation 9: Health Canada should regularly revise health warning messages to ensure they are appropriate to the product, reflect up-to-date evidence on the health risks associated with cannabis and are impactful in communicating these risks. Additionally, Health Canada should reinstate health warning messages that pertain to serious cannabis-related mental health risks, including psychosis and schizophrenia.

Recommendation 10: Health Canada should revise the packaging and labelling rules that apply to all cannabis products to more clearly convey information on delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) quantity or concentration to adult consumers, by simplifying product labels and allowing the display of only "total THC" and "total CBD" for each unit and for the package, and by requiring larger font sizes to display THC and CBD quantity (or concentration).

Recommendation 11: Health Canada should consider allowing some portion of a cannabis package (for dried cannabis and fresh cannabis only) to be transparent, without undermining the intent of plain packaging requirements and other labelling rules to protect children.

Recommendation 12: Health Canada should revise the packaging and labeling rules to allow for the display of certain symbols that convey useful information to the consumer (for example, symbols related to organic certification or recycling), ensuring that permitted symbols do not serve as an inducement to youth or non-consumers.

Recommendation 13: Health Canada should revise packaging and labelling rules to allow the use of QR codes on product labels to convey factual information to consumers, within the constraints of what is currently permitted on labels or in cannabis promotions.

Recommendation 14: Health Canada should develop a "standard dose" or "unit dose" (as appropriate for different classes of cannabis). The development of a standard dose should be prioritized and accompanied by regulatory amendments to require it as an element on cannabis product labels.

Recommendation 15: Health Canada should be vigilant with its regulatory enforcement efforts, with priority given to taking action against regulated parties who do not comply with rules that protect youth and to taking action when regulated parties repeatedly demonstrate non-compliance.

First Nations, Inuit and Métis

Recommendation 16: The Government of Canada, including Indigenous Services Canada, should continue to enhance and expand distinctions-based health, public health and mental health wellness supports, that are culturally appropriate, trauma-informed and in partnership with First Nations, Inuit and Métis communities.

Recommendation 17: We agree with the Standing Senate Committee on Indigenous Peoples that Health Canada and Indigenous Services Canada should work with Indigenous Peoples and communities to establish and fund a research strategy on cannabis and its effects on Indigenous Peoples and communities, recognizing that this research should be led, owned and used by First Nations, Inuit and Métis communities.

Recommendation 18: Health Canada should commit to co-developing culturally appropriate, evidence-based materials and programs to disseminate cannabis-related health information on a distinctions-basis with First Nations, Inuit and Métis.

Recommendation 19: The Government of Canada should take steps to amend the definition of intoxicant in the Indian Act to enable First Nations band councils to enact bylaws regarding cannabis.

Recommendation 20: We agree with the Standing Senate Committee on Indigenous Peoples that the Government of Canada, as it develops legislation in collaboration with the provinces and the territories, and First Nations governments, should establish legislative mechanisms for the enforcement of band bylaws and other laws related to cannabis by all police services, and to ensure that related offences can be investigated and prosecuted effectively.

Recommendation 21: We agree with the Standing Senate Committee on Indigenous Peoples that the Government of Canada should ensure adequate funding and training is available to First Nations communities for the policing and enforcement of band bylaws related to cannabis to better protect public health and public safety. We also encourage the Public Prosecution Service of Canada and other agencies at the provincial and territorial level to support training efforts for prosecutors on the laws of First Nations communities.

Recommendation 22: Health Canada should better advertise and evaluate existing supports for Indigenous licence applicants to determine if they are meeting needs in an effective way. Health Canada should also apply the recommendations we have made on broader measures to support equity-deserving groups and micro-licence applicants and holders to Indigenous applicants.

Recommendation 23: Health Canada should take immediate steps to co-develop, with First Nations, Inuit and Métis, amendments to the Cannabis Act to better protect public health and public safety in Indigenous communities. These amendments should authorize the Minister to enter into nation-to-nation agreements with interested First Nations, Inuit and Métis to control commercial cannabis activities in their communities, when certain minimum standards are met. Over the longer-term, it is our hope that learnings and outcomes from these agreements and other processes could be used to inform the United Nations Declaration on the Rights of Indigenous Peoples implementation work for cannabis.

Recommendation 24: We agree with the Standing Senate Committee on Indigenous Peoples that Finance Canada should work with First Nations to identify options for the development of an excise tax-sharing framework as part of its discussions on fuel, alcohol, cannabis and tobacco taxes.

Recommendation 25: Health Canada should prioritize and accelerate its work on regulatory streamlining to reduce the administrative burden on federal licence holders, while ensuring that the public health and public safety objectives of the Cannabis Act are not compromised.

Recommendation 26: Health Canada should amend the regulations to allow cultivators, including micro-cultivators, to sell packaged and labelled dried or fresh cannabis directly to distributors. Cultivators should be required to follow the same quality assurance and testing requirements for dried cannabis that apply to processors.

Recommendation 27: Finance Canada should consider a review of the excise tax model, recognizing that it was originally designed when the average price of dried cannabis was significantly higher than it is today. Further, Finance Canada should consider making reforms to the excise tax regime that would discourage the consumption of higher-risk cannabis products, for example, by applying progressively larger duties on cannabis products with higher quantities or concentrations of delta-9-tetrahydrocannabinol (THC) (or other intoxicating cannabinoids).

Recommendation 28: Health Canada should be more transparent with the data it holds on the state of the cannabis market and ensure that prospective licence applicants are provided with this information, in sufficient detail, to allow them to assess the feasibility of their business plans based on current market conditions.

Recommendation 29: Health Canada, in consultation with Agriculture and Agri-Food Canada, should establish and support an expert advisory body to conduct a timely review of the regulation of industrial hemp and make recommendations about the most appropriate regulatory framework.

Recommendation 30: Health Canada should carefully examine, and where appropriate revise, its approach to regulatory fees for equity-deserving groups and micro-licence holders. This examination should include an assessment of how regulatory fees could be modified to promote greater diversity among participants in the legal cannabis market.

Recommendation 31: Health Canada should work with relevant departments to ensure that federal licence holders and applicants, particularly small and equity-deserving businesses, are informed of existing programs (such as for grants and loans), incentives and supports that may assist them in establishing and running their businesses. Health Canada should offer post-licensing supports to help these companies navigate regulatory compliance and other business-related responsibilities.

Recommendation 32: The Government of Canada should consider whether offences under the Cannabis Act should be considered under the automatic record sequestration process that will come into force in November 2024.

Recommendation 33: Health Canada should enhance and expand informational materials and educational programs related to cannabis for equity-deserving groups and subpopulations, in partnership with these communities, to ensure they are non-stigmatizing and culturally appropriate.

Recommendation 34: Health Canada should regularly collect and analyze demographic data from licence holders to assess diversity in the industry (including ownership, leadership and the workforce). Health Canada should publish this information in a timely manner to allow the public to monitor the diversity of representation in the industry.

Recommendation 35: The Government of Canada should make substantial improvements in the systematic collection and publication of data related to cannabis that is disaggregated by relevant demographic indicators, such as race. Appropriate data safeguards must be in place to protect privacy and prevent further stigmatization.

Recommendation 36: The Government of Canada should establish indicators related to the environmental impacts of the cannabis industry, collect baseline data and continue to monitor these indicators and their trends. The Government of Canada should publish this information in a timely manner to allow the public to monitor progress.

Recommendation 37: Health Canada should maintain the current limit of 10 milligrams of delta-9-tetrahydrocannabinol (THC) per package in edible cannabis products and continue to develop the research in this area to determine whether there are conditions under which the limit could be raised without unduly impacting public health.

Recommendation 38: Health Canada should provide Canadians who choose to grow cannabis at home with information on the potential risks associated with home cultivation, as well as practical advice on how to grow and store cannabis safely.

Recommendation 39: The Government of Canada should work with provincial and territorial governments to help consumers identify legal retailers and products, especially online, and prioritize public communication on the health risks associated with illicit products.

Recommendation 40: The Government of Canada should consider creating authorities to compel Internet service providers to block illicit cannabis websites and to compel financial service operators to provide financial information that helps identify illicit online operators.

Recommendation 41: In order to provide access and continued support to patients who rely on the medical access program, Health Canada should maintain the program under the Cannabis Regulations , with the improvements set out in this report.

Recommendation 42: To improve patient access to cannabis for medical purposes, Health Canada should permit pharmacies to distribute cannabis products to individuals holding a medical authorization from a health care professional. Provinces and territories and the regulatory authorities for pharmacists should consider supporting this new access channel for patients once federal changes are made.

Recommendation 43: Health Canada should encourage additional research on the therapeutic use of cannabis in Canada, without compromising the frameworks established for the review and authorization of clinical trials and health products. Health Canada should support a transparent process to identify the specific potential therapeutic applications of cannabis that would benefit most from additional study.

Recommendation 44: Health Canada should establish and maintain a knowledge hub that provides up-to-date evidence and information on the use of cannabis for medical purposes for health care professionals and the public.

Recommendation 45: Health Canada, in partnership with provinces, territories, patients and health care professionals, should support the development and dissemination of national clinical guidance documents related to cannabis for medical purposes to increase the knowledge and understanding of health care professionals. These documents should cover issues such as: indications for which there is a sufficient evidence base of effectiveness, how to monitor patients, and how to track and report adverse reactions.

Recommendation 46: Health Canada should prioritize efforts to move beyond a distinct medical access program so that cannabis is considered within standard drug approval pathways and part of conventional medical care. This should start with the rapid advancement of a pathway for cannabis health products containing cannabidiol (CBD). The department should also establish a science advisory committee to review the evidence related to delta-9-tetrahydrocannabinol (THC).

Recommendation 47: To support patient care, Health Canada should amend the regulatory requirements related to the medical document to allow health care professionals to include specific information about the product format and dose of cannabis for the patient, similar to prescriptions for other substances.

Recommendation 48: To address public safety concerns, Health Canada should limit the number of registrations for personal or designated production of cannabis for medical purposes at a single site (where 4 are currently allowed, decrease to 1 registrant per site).

Recommendation 49: Health Canada should build on its recent efforts to seek additional clinical justifications from health care professionals authorizing high daily amounts and consider whether and how additional scrutiny could be applied. Health Canada should use its regulatory authorities to refuse and revoke applications that are deemed to pose a risk to public health or public safety.

Recommendation 50: Finance Canada should review whether the excise tax should be applied to cannabis for medical purposes products.

Recommendation 51: Health Canada, Public Safety Canada, Statistics Canada, the Canadian Institutes of Health Research and other partners should work with stakeholders, including those with lived and living experience and from marginalized communities, to identify key research priorities. This prioritization effort should guide ongoing investment in cannabis-related research.

Recommendation 52: Health Canada, Public Safety Canada, Statistics Canada and other partners should support ongoing surveillance and monitoring activities for cannabis that are responsive to the variety of potential impacts of cannabis and cannabis legalization, including monitoring the state of the cannabis market, social equity impacts and environmental consequences of cannabis legalization.

Recommendation 53: Health Canada should take steps to develop an amendment to the Cannabis Act to mandate periodic independent reviews of the legislation to regularly monitor its impacts. Consideration of the social equity impacts of the legislation should be mandated as an element of future reviews.

Recommendation 54: In addition to regular independent reviews of the Cannabis Act, Health Canada should conduct ongoing evaluation of the cannabis program, and implement any necessary changes.

Observations

Observation 1: Federal, provincial and territorial governments should allocate a portion of cannabis revenues to fund cannabis-related public health and public safety initiatives.

Observation 2: Distributors and retailers should stock cannabis products with diverse ranges of delta-9-tetrahydrocannabinol (THC) quantities or concentrations and take steps to encourage customers to choose lower-THC products whenever appropriate.

Observation 3: Provinces and territories should allow more flexibility in their distribution and retail systems, both through incentives (lower mark-ups, for example) and, for those provinces with publicly-controlled retail, creating space for Indigenous owned and operated retail stores.

Observation 4: Provincial and territorial governments should consider permitting direct-to-consumer sales from smaller cultivators and processors (farmgate, or mail order within a jurisdiction), in a way that allows smaller players to generate and keep more revenue than they would by selling cannabis through distributors.

Observation 5: Provincial and territorial distributors should consider regularly reviewing their mark-ups, fees, purchasing practices and the amount of shelf space they allocate to different products and different licence holders, including those from equity-deserving groups, to improve the prospects for the many smaller-sized companies that are currently struggling.

Observation 6: Law enforcement should focus its efforts on the activities of organized crime and criminal networks, the diversion of cannabis from sites registered for personal and designated production, the proliferation of retail stores on First Nations reserves operating without provincial, territorial or community authorization and illicit online sellers. There is also a role for regulatory authorities to play in combatting the illicit market.

Observation 7: Provincial and territorial governments should consider creating authorities to compel Internet service providers to block illicit cannabis websites and to compel financial service operators to provide financial information that helps identify illicit online operators.

Observation 8: Parliamentarians should consider how the proposed Online Harms Act could be used to protect children and youth from the harms associated with exposure to substances, including cannabis.

Observation 9: Law enforcement should prioritize enforcement of cannabis-impaired driving, supported by appropriate resources and additional training of officers, particularly for rural and remote police services.

Observation 10: The regulators for health care professionals should use their authorities to investigate and sanction health professionals with problematic authorization practices.

Observation 11: Provincial and territorial regulatory authorities should require health care professionals (including physicians, nurse practitioners, and, if applicable, pharmacists) to disclose financial relationships with licence holders. This work could build on existing policies governing health professional relationships with the pharmaceutical industry.

Setting the context for the legislative review

The control framework under the Cannabis Act (the Act) marks a radical departure from a century of prohibition. The decision by Parliament to require an independent review 3 years after the Act's coming into force is an implicit acknowledgement that there would likely be gaps between what Parliament intended to achieve with the legislation and other supporting measures, and the practical implementation of those elements.

In legalizing and regulating cannabis, Parliament opted to replace the regime of prohibition with one based on the protection of public health and public safety. The rationale for this approach was to better protect youth, displace the illicit market and provide adults with a legal source of quality-controlled cannabis. Legalization also results in societal benefits, including lessening the harms of convictions for simple cannabis possession, disrupting the control of cannabis trade by organized crime and minimizing the danger this trade poses to communities, and addressing the health risks associated with using illicit supply. We feel it is important to emphasize that the message of the Act is not that cannabis is harmless, but that Parliament chose an approach based on public health and public safety, rather than prohibition. We believe the focus should remain on the public health (including mental health) and social consequences of regular and heavy use of cannabis, as well as the impact on vulnerable populations.

It has been 5 years since the Act came into force and Canada's experience with this new public health approach to cannabis is still in its early days. Given this, there has been limited time to collect data and evaluate results, and barriers to research remain. These limitations hindered our efforts to assess the impacts of legalization, and they also negatively impact the collective understanding about the potential risks and benefits of cannabis use.

Throughout the review, it became clear that stakeholders have different understandings of the definition and application of "public health" and "public safety". Generally, public health stakeholders were less willing to accept any relaxation of public health controls to transition consumers from the illicit to the legal market. They were primarily focused on public health objectives and accept that certain consumers will continue to purchase from the illicit market. Industry stakeholders, however, were generally of the view that the illicit market poses a significant problem for public health and public safety. They advocated for measures that would attract more consumers to the legal market and greater enforcement against illicit actors. We believe that the current framework is a balanced combination of these perspectives; it implements a range of controls and enables other measures, while also allowing for the sale of a wide variety of cannabis products to adults who choose to use cannabis.

Examining the foundational objectives of the Act

We recognized that the core of the regime, and thus the starting point for this review, is the purpose set out in section 7 of the Act. It sets out that the objectives of the legislation are to protect public health and public safety and, in particular, to:

• protect the health of young persons by restricting their access to cannabis
• protect young persons and others from inducements to use cannabis
• provide for the licit production of cannabis to reduce illicit activities in relation to cannabis
• deter illicit activities in relation to cannabis through appropriate sanctions and enforcement measures
• reduce the burden on the criminal justice system in relation to cannabis
• provide access to a quality-controlled supply of cannabis
• enhance public awareness of the health risks associated with cannabis use

All the elements of section 7 can be viewed as the means by which the Government of Canada aims to protect public health and public safety. These are the overarching objectives of the Act. We note the specific reference to the protection of the health of young persons.

Section 7 also specifies that providing for a legal supply of cannabis is a means of achieving the public safety objective of reducing illicit activity in relation to cannabis, as well as the public health goal of providing access to a quality-controlled supply of cannabis for those who choose to consume it. The commercial market permitted by the cannabis framework must therefore be viewed in terms of supporting the public health and public safety goals of the Act.

We carefully considered issues related to the sustainability of the legal industry and its ability to provide a quality-controlled supply of cannabis for adults, as well as issues related to social equity and diversity in the industry. However, in formulating our advice on how to better achieve a sustainable cannabis industry, we took care not to compromise the overarching objectives of the Act.

In supporting the objectives of the Act, deterring illegal activity requires both appropriate sanctions (that is, offences and penalties) and enforcement. The Act sets out appropriate sanctions; however, the legislation itself cannot mandate enforcement. Sanctions without effective enforcement risk undermining the objectives of the Act.

Section 7 also notes that an objective is to enhance public awareness of the health risks associated with cannabis use. We feel that such activities require the ongoing provision of information, supported by the best available evidence, as well as prevention initiatives, supported by sustained investment. Improving the awareness of the health risks associated with cannabis for different segments of society is important.

Many risks of cannabis use are well known. For example, there is substantial evidence that early initiation and frequent use of cannabis, especially high-potency products, can lead to addiction, that use during pregnancy is associated with low birth weight and that frequent use and use of high-potency products are associated with the development of schizophrenia or psychosis.

However, there remain very significant knowledge gaps on the risks and benefits of cannabis use. This is also true of the impacts of the new framework, and it may take many years to fully assess its impacts. Section 7 of the Act is silent on the need for continuous research and surveillance. Yet without continued investments in these areas, future efforts to evaluate the impacts of the new approach will be hindered. This is a theme that emerges throughout this report and has led to several of our recommendations.

Finally, we note that section 7 does not include the generation of revenue as an objective of the Act. We agree with the Task Force on Cannabis Legalization and Regulation (a group of experts that advised the Government of Canada on the design of the framework in 2016) that "revenue generation should be a secondary consideration for all governments, with the protection and promotion of public health and safety as the primary goals". Footnote 3 Yet, we note that governments have been the primary beneficiaries of revenue generated from the sale of cannabis.

We believe that Parliament's objectives for the legislation, set out in section 7, will not be achieved without sustained resources.

In preparing this report, we sought to identify key issues and make recommendations in areas where we felt reforms or additional resources were needed. We did not undertake cost analyses or specify the appropriate level of investment or funding. We recognize that in some circumstances difficult decisions will need to be made about when, or the extent to which, our recommendations can be implemented. While some new investments may be required, we encourage all levels of government to consider how existing resources can be redirected, and to consider how cannabis fits into broader priorities (for example, investment in mental health and addictions services, prevention programs, consumer information, and research and surveillance).

We engaged with stakeholders and experts between December 2022 and January 2024 to gather evidence and perspectives related to the areas we were asked to review. We approached stakeholder engagement with humility; we listened and learned from the perspectives shared with us, including those from people with lived and living experience. We acknowledge that barriers exist for many groups in engaging in processes like this review, including historical power imbalances, resource or capacity limitations and access issues. We took measures to address some of these barriers, including offering various modes of participation and making use of trusted interlocutors, such as community leaders and youth advocates, to help facilitate conversations and hear diverse voices.

We hope that we have captured the breadth and nuances of these perspectives and acknowledge that any errors are our own.

Summary of engagement process

We engaged with:

• researchers and academics in various fields (including public health, public safety, criminal justice and economics)
• health care professionals, organizations and regulatory authorities
• people working in the areas of public health and harm reduction
• youth and youth advocates
• First Nations, Inuit and Métis (including leaders, governments, community organizations, representatives from National Indigenous Organizations, police and health services, industry members and Elders)
• the cannabis industry (including federal licence holders, distributors, regulators, retailers and industry associations)
• equity-deserving groups
• people with diverse lived and living experience
• international policy leaders
• various levels of government
• law enforcement representatives
• stakeholders involved in the use of cannabis for medical purposes (including patients and their caregivers, patient advocacy groups, researchers, health care professionals, cannabis clinics and those operating outside of the medical access system)

In our engagement with First Nations, Inuit and Métis, we adopted a distinctions-based approach. Footnote 1 This included tailoring aspects of our discussions to the unique goals and priorities of First Nations, Inuit and Métis, recognizing each has different ways of knowing. We sought to engage at the individual, community, regional and national levels, and were honoured to have been invited to visit some communities in person. We acknowledge that we were only able to meet with a small fraction of nations.

Before we were appointed, Health Canada launched an online engagement process, supported by 2 engagement papers: Taking stock of progress: Cannabis legalization and regulation in Canada and Summary from engagement with First Nations, Inuit and Métis Peoples: The Cannabis Act and its impacts . Health Canada received over 2,100 responses to their online questionnaires and over 200 written submissions. We received a briefing on the results of this online engagement process and were provided access to the submissions received. We thank all those who took the time to submit their views in that process.

Overview of engagement activities

We used a range of methods to conduct our engagement. These activities occurred with stakeholders throughout Canada, through in-person meetings, videoconferences and in a hybrid format. As described in our What We Heard Report , we initially engaged with stakeholders on a one-on-one basis and by sector. This afforded stakeholders the opportunity to provide us with comprehensive perspectives on their key issues.

In total, we:

• met with over 600 individuals from over 250 organizations in nearly 140 meetings
• completed 10 sector-based roundtable meetings (public health, justice and public safety, industry, 3 meetings with patients and advocates, 2 meetings with youth and young adult advocates, multi-sectoral roundtable on public health and industry issues, multi-sectoral roundtable on medical access)
• completed 5 roundtables focused on issues related to diversity, equity and inclusion (women in the industry, issues specific to Black Canadians, social equity issues, harm reduction measures, learnings from other jurisdictions)
• undertook distinctions-based engagement activities with First Nations, Inuit and Métis (this included meetings with: British Columbia-based First Nations, organized in partnership with the First Nations Leadership Council; representatives of the 4 Inuit regions, organized in partnership with Inuit Tapiriit Kanatami and Pauktuutit Inuit Women of Canada; the Manitoba Métis Federation; the Métis National Council; the Assembly of First Nations; the Anishinabek Nation; the Mohawk Council of Akwesasne; the Mohawk Council of Kahnawà:ke; Samson Cree Nation; Shxwhá:y Village; Six Nations of the Grand River; Tyendinaga [Mohawks of the Bay of Quinte]; Williams Lake First Nation)
• visited sites of licence holders involved in cultivation and processing, retail stores, harm reduction sites and cannabis clinics
• engaged with stakeholders operating outside of federal, provincial or territorial licensing frameworks
• heard from the Students Commission of Canada, which facilitated roundtables with youth on our behalf
• received over 250 written submissions

A full list of the stakeholders we engaged with is in Appendix B. While significant effort was made to ensure we heard from a broad range of voices, we acknowledge that some viewpoints may be more limited. In keeping with our commitment to those we engaged with, we have not attributed comments to specific individuals or organizations, unless their views are in the public domain or the stakeholder requested it.

We would like to thank everyone who generously gave us their time and energy in sharing their perspectives, whether in writing or in a discussion. We hope that this first review marks the beginning of a continuing review process where diverse groups are engaged regularly to assess the cannabis legislative framework and its implementation.

On October 17, 2018, Canada became the first major developed nation in the world to legalize and regulate cannabis when the  Cannabis Act (the Act) and its regulations came into force. The purpose of the Act is to protect public health and public safety, including by providing access to a quality-controlled supply of cannabis, and by enhancing public awareness of the health risks associated with cannabis use.

The Act recognizes federal, provincial and territorial authorities with respect to the production, distribution and sale of cannabis. These include authorities that enable the Government of Canada (the Minister of Health) to issue licences and permits authorizing activities such as production, import, export and sale. The provinces and territories have all exercised authority over the distribution and sale of cannabis under provincial and territorial law. The Act does not set out authorities related to First Nations, Inuit or Métis governments.

The federal framework

Under the Act, the Government of Canada is responsible for licensing various activities with respect to the production of cannabis (including industrial hemp), including cultivation, processing and testing, as well as associated activities, such as possession, distribution, sale and research with cannabis. The Government of Canada also establishes and oversees compliance with the rules that apply to cultivating and manufacturing cannabis for commercial sale, including:

• the requirements to obtain a licence (for example, physical and personnel security measures)
• the types of cannabis products that can be made available for sale
• the rules that apply to the production and formulation of cannabis products, including mandatory testing requirements and delta-9-tetrahydrocannabinol (THC) quantity or concentration limits
• the packaging and labelling requirements for cannabis products
• the tracking requirements that apply to those authorized to produce and sell cannabis to prevent diversion and inversion of cannabis out of or into the legal system

The Government of Canada is also responsible for overseeing a framework to provide access to cannabis for medical purposes under the Act. This framework enables Canadians, including young persons, to access cannabis for their medical needs from commercially-licensed sellers or through personal or designated production.

The Act prohibits the promotion of cannabis, cannabis accessories or related services, except in limited circumstances. Prohibited promotions include those that:

• are considered appealing to young persons
• are false, misleading or deceptive
• are likely to create an erroneous impression about the health effects of cannabis or evoke a positive emotion or image of a way of life (for example, glamour)
• use sponsorship, testimonials or endorsements
• depict a person, celebrity, character or an animal

The Act does permit promotion, under specific conditions, to help adult consumers make informed decisions about cannabis. For example, it allows for informational promotion, such as price and availability (that is, information about how it can be obtained), as well as brand-preference promotion (such as promotion on attributes of the cannabis like "sun grown" or "organic"), in material addressed to adults over the age of 18 or in places where youth are not permitted by law.

The Act contains a series of criminal offences and sanctions (for example, ticketing and imprisonment) to deter illicit activity related to cannabis, with exceptions for certain individuals and authorized parties.

Control measures in the Act include:

Restricting youth (people below 18 years of age) from accessing cannabis

• Prohibiting youth from possessing more than 5 grams of dried cannabis (or its equivalent in other classes of cannabis)

Controlling access to cannabis for adults of legal age

• Prohibiting individuals and organizations from selling cannabis, unless authorized to do so under the Act
• Limiting adult possession in public to 30 grams of dried cannabis (or its equivalent in other classes of cannabis)
• Limiting home cultivation to 4 plants per dwelling-house

Protecting public safety

• Prohibiting production, distribution and sale, unless authorized
• Prohibiting distribution and sale to youth
• Prohibiting import and export, with exceptions for licence holders with a permit and only for a scientific or medical purpose (or in respect of industrial hemp)

The implementation of the Act and its regulations is supported by various activities related to licensing, regulatory compliance and enforcement, criminal enforcement, research and surveillance, and public education, such as:

• issuing and renewing licences and security clearances
• promoting and monitoring regulatory compliance, including through risk-based inspections of federal licence holders to determine whether requirements are being met (for example, whether cannabis products have been tested, if appropriate records are kept about production and sale)
• investigations, charges and court proceedings related to infractions of the criminal offences in the Act
• monitoring data to identify and track emerging trends and risks (for example, risks posed by new cannabis products)
• funding research on the public health and public safety impacts of legalization, the therapeutic potential of cannabis, the cannabis plant and its components, and social science research on topics such as stigma, diversity and inclusion
• providing public education to Canadians to educate and raise awareness of the health and safety risks associated with cannabis use, prevent problematic use and promote informed choices

Other elements of the federal cannabis framework are found in other pieces of legislation, including:

• Criminal Code : Laws related to impaired driving
• Excise Act, 2001 : Laws related to the duty payable on cannabis products by federal licence holders

Provincial, territorial and municipal roles and authorities

Provinces and territories are responsible for overseeing the distribution and sale of cannabis within their jurisdictions. They have established a range of distribution and retail models (public, private and hybrid), and must have legislation that subjects authorized sellers to the measures set out in section 69 of the Act . These measures are that the cannabis sold or distributed must be supplied by a federal licence holder, there be no sale to minors, there be appropriate records of their activities and they take adequate measures to protect against diversion of the cannabis to the illicit market.

Provinces and territories have the authority to establish additional controls, such as:

• increasing the minimum age for adult possession, but not lowering it (all provinces and territories have increased the minimum age to 19, except Alberta where the minimum age is 18 and Quebec where the minimum age is 21)
• lowering the personal possession limit (no provinces and territories have elected to do this)
• creating additional rules for growing cannabis at home, such as lowering the number of plants per residence (for example, home cultivation of cannabis is prohibited in Quebec and Manitoba)
• restricting where adults can consume cannabis, such as in public or in vehicles (all provinces and territories have placed prohibitions or limits on public consumption, with most aligning with their existing rules related to tobacco)
• limiting access to certain types of products (for example, Quebec has restricted certain types of edible cannabis products)

Local governments and municipalities may develop bylaws on issues such as zoning, public consumption and fire prevention.

While the Act addresses the role and authorities of federal, provincial and territorial governments, there is no similar recognition of First Nations, Inuit and Métis governments. Under other established legislation and authorities (for example, the Indian Act or municipal authorities), some additional laws or requirements can be created (for example, zoning bylaws), provided they do not conflict with the Act.

Social equity considerations

While the framework takes into account societal behaviours and social factors (for example, reducing harms for adult consumers and youth, reducing criminal activity and allowing adult access to quality-controlled cannabis), there are no social equity objectives or explicit measures for marginalized or disadvantaged groups, with the exception of certain flexibilities for licensing applications and supports for Indigenous and Indigenous-affiliated applicants. Footnote 4

Introduction

The framework implemented by the Cannabis Act (the Act) sought to balance multiple objectives, notably to protect public health and public safety while also providing access to a quality-controlled supply of cannabis. In providing their advice to the Government of Canada, the Task Force recognized that a balanced approach was most likely to achieve the government's public policy goals, and that both highly permissive and highly restrictive regimes would lead to health and social harms that would be unacceptable to Canadians.

The framework was designed to minimize the harms associated with cannabis use. A variety of instruments were used to achieve this, including legislative and regulatory controls on issues such as: production practices, product composition, ingredient standards and limits, delta-9-tetrahydrocannabinol (THC) limits, and promotion, packaging and labelling requirements, among others. Footnote 5 , Footnote 6 Non-regulatory tools, including the dissemination of evidence-based information, research and surveillance activities, and financial support for community-based programs, also play important roles in minimizing the harms associated with cannabis use and protecting vulnerable populations.

The legalization of cannabis was a major policy shift in Canada, and the consequences of this change continue to emerge. In view of the ongoing evolution of cannabis use behaviours and the cannabis market, the limited time that has passed since legalization and the shortcomings in the evidence base, we have exercised caution in making our recommendations.

Concerning public health trends

Throughout our review, concerns were raised about the impacts of legalization on Canadian children and youth. Increasing reports of poisonings of children who have unintentionally consumed cannabis are troubling. While pre-legalization fears about increased use by adolescents have not materialized, use has not decreased in the same way that youth smoking and alcohol use have, and cannabis remains easy to access for those under the legal age. Footnote 7

There is a concerning shift toward increased prevalence of cannabis use and increasingly potent cannabis products in the legal market, including dried cannabis, vaping products and infused pre-rolled joints (that is, products with high quantities or concentrations of THC). As well, while the dramatic reductions in the price of cannabis seen over the past 5 years may be driven by economic forces, we worry that lower retail prices will likely contribute to increased consumption of cannabis and elevate the risk of cannabis-related harms (for example, addiction, psychosis, depression, anxiety).

Risks to youth and children

The research is clear that exposure to cannabis can disrupt normal brain development, which continues up to the age of 25. Earlier use and more intensive patterns of cannabis use increase the risk of serious adverse effects. The social and cultural normalization of substances, such as tobacco and alcohol, increases curiosity about these products, lessens the perceived risks and may influence individuals, especially youth, to underestimate their potential harm. Cannabis-related behaviours and perceptions should be monitored across all age groups to ensure that normalization of cannabis use among youth does not become an unintended consequence of legalization. There is a role for the Government of Canada to play in protecting youth from the harms of cannabis by discouraging normalization of cannabis use, fostering informed decision-making and helping youth to develop skills that will better protect them from the early use of substances (including cannabis).

While mass marketing campaigns may help to raise general awareness or provide basic, factual information, efforts to delay the start of cannabis use, and to encourage safer use among those young people that do use cannabis, should be thoroughly evaluated and based on solid evidence. Interventions (such as youth-focused interventions offered in schools relying on both evidence-based content and approaches) can be effective at addressing substance use among youth.

Academic studies and reports demonstrate increases in the number of children being poisoned as a result of accidentally consuming cannabis. Our What We Heard Report summarized several studies, and a more recent article provides updated figures on emergency department visits and hospitalizations for cannabis poisonings among children aged 0 to 11. The study found significant increases in emergency department visits for cannabis-related poisonings between 2015 and 2021 in Ontario and Alberta. Hospitalization data, available from all provinces and territories except Quebec, also showed significant increases in the rate of cannabis-related poisonings, from 0.5 per 100,000 in 2015 to 6.4 per 100,000 in 2021. Footnote 8

We are deeply concerned about this trend. Children should never be able to access cannabis and these poisonings should never occur. In a series of recommendations throughout this report, we emphasize the importance of maintaining key measures that protect children (for example, child-resistant packaging and a prohibition on products that appeal to youth, among others), call for more research in this area and recommend redoubled efforts to educate consumers, including parents and caregivers, about ways to prevent these poisonings. We also call on retailers and provinces and territories to provide information to consumers about how to safely store cannabis in their homes (discussed further in Chapter 9).

Protecting children, youth and young adults from the harms of cannabis

Balancing responsible and informed access to cannabis for adults while prioritizing the protection of youth is critical. We feel that it is important to avoid normalizing or glamorizing cannabis. While most Canadian youth do not use cannabis, a social norm which should be noted, rates of cannabis use among Canadian youth are among the highest in the world, and youth are more vulnerable to cannabis-related harms. While cannabis use among youth has been relatively stable, the 2023 Canadian Cannabis Survey noted an increase in use among youth aged 16 to 19 compared to the previous year (although the result was similar to 2019 and 2020). Footnote 9

To ensure the Government of Canada is clear about its goals, and to reduce cannabis-related harms experienced by youth, Health Canada should establish targets to reduce the prevalence of cannabis use among youth, drawing from lessons learned in tobacco control.

Ongoing monitoring of youth cannabis use, cannabis-related poisonings and other cannabis-related harms is necessary to avoid unintended and undesirable consequences of legalization. To identify important differences in the impact on different subpopulations, monitoring should include collection of disaggregated data and consider a variety of factors (for example, age, sex, gender, sexual orientation, race/ethnicity and types of cannabis products used). To support reductions in youth use and the harms that result from use, the Government of Canada should work with partners and implement a multi-faceted strategy to support prevention, encourage less harmful use and ensure availability of treatment to those that need it. Approaches that aim to reduce cannabis use and harms should include the development and implementation of targeted health interventions that meet the needs of specific populations, and that are responsive to emerging trends. Footnote 10

Addressing accidental exposures to cannabis

There are substantial knowledge gaps about cannabis-related poisonings, including the relative contribution of legal cannabis, homemade cannabis products and illicitly sourced cannabis. Irrespective of where they obtain it, adults must always store cannabis in locations that cannot be accessed by children. We recognize Health Canada has made efforts to inform the public of these risks and to educate consumers on the importance of safe storage, but with the rising number of childhood poisonings, we believe these efforts should be redoubled.

Additionally, we encourage other levels of government, distributors and retailers to also encourage consumers to store cannabis safely.

Informing consumers about the risks associated with cannabis

There is room for improvement in how Health Canada and other authorities disseminate cannabis information, both for youth and for the broader population. Initial federal communications efforts after legalization largely aimed to disseminate information about the legal regime (for example, what was and was not legal and rules on impaired driving and crossing borders), as well as to communicate the health risks of cannabis and how to lower risks associated with consumption (for example, the Lower-Risk Cannabis Use Guidelines published in 2017 and updated in 2021). Footnote 11 , Footnote 12 Health Canada has also supported targeted efforts to reach certain populations (for example, youth and parents), although certain risks (for example, cannabis-related psychosis) and certain populations (for example, people with a family or personal history of mental health disorders) have not received sufficient attention, in our view. Footnote 13

There is an opportunity to refocus these communication efforts by taking a more evidence-based approach to disseminating information on cannabis use and the associated risks and harms. More focus should be placed on the unique interests and needs of different consumer populations. Informational materials and other measures should be co-designed with the intended target group or population to help make the information accessible, relevant and reflective of their needs and lived experiences. Informational and education programs need to be fact-based, non-stigmatizing, culturally sensitive, regularly evaluated and adjusted accordingly.

Emphasizing the need for prevention programs

Providing information about cannabis to the general public, or to certain communities, is necessary but not sufficient. Further research is needed on the most effective ways to increase awareness, inform and educate as part of a broader strategy. Specifically, more research is needed on more intensive interventions like targeted prevention programs (for example, brief, personality-targeted, cognitive-behavioural interventions) and other interventions for frequent consumers and those at risk (for example, screening, referral to treatment). Footnote 14 Such measures also have important roles to play in reducing harms from cannabis at a population level.

We recommend that federal, provincial and territorial governments come together to fund and support the development and implementation of evidence-based school prevention programs and other interventions that equip youth to make better decisions about substance use (including cannabis), to avoid or delay the use of cannabis and other substances, and to engage in lower-risk substance use behaviours. We acknowledge the complexity of implementing these measures, and the need for collaboration and coordination among the educational system, researchers and organizations with expertise in developing, implementing and evaluating these kinds of programs.

Ensuring youth have a voice

We sought the perspectives of youth during our engagement and were impressed by the knowledge and insights that young Canadians shared with us. For example, we heard from youth that there is not enough reliable, unbiased, accessible and accurate information on cannabis that is tailored to them (such as the long-term effects of cannabis use, how it affects people differently and guidance on how cannabis can be used to respond to a medical condition).

Even though youth protection is a key objective of the cannabis framework, Health Canada does not have an established mechanism for engaging youth about cannabis. The Tobacco Youth Leadership Team is a model that could be adopted for cannabis. We encourage Health Canada to prioritize engagement with youth on cannabis, using a Sex and Gender-Based Analysis Plus lens.

Addressing high-potency cannabis products, novel products and their risks

The Act and its regulations permit the production of a wide range of cannabis products to allow the legal industry to innovate and compete with the illicit market. While the Task Force recognized the risks of consuming high-potency products, it ultimately recommended that these products be included as part of the regulated market and be subject to safety and quality-control measures to offer consumers a less harmful choice. The Task Force also noted that production practices for high-potency cannabis concentrates (for example, shatter) in the illicit market often involved toxic and flammable solvents that create risks of fires and explosions. In addition, the Task Force noted that without appropriate safeguards, harmful residues from these solvents could end up being concentrated in the illicit products and consumed. Health Canada regulates how licence holders manufacture such products to mitigate these risks.

The products available in the cannabis market today are different than the products that were used historically in cannabis research or that some groups of consumers may recall using in the past. In addition to increasing quantities or concentrations of THC, there are product innovations (for example, "fast-acting" edible cannabis), newer product formats and changing patterns of use. Products with large amounts of cannabidiol (CBD) are also available. Footnote 15 There are also unknown health risks related to the use of different types of cannabis products, including emissions from smoked and vaped cannabis.

Risks of high-potency cannabis products and novel products

While continued product innovation is expected, there must be recognition of the risks associated with high-potency products and with some novel products, particularly for youth. There has been a shift toward the sale and use of higher-potency cannabis products. For example, the majority of dried cannabis sold contains greater than 20% THC, and high-potency vaping products and infused pre-rolled joints appear to be gaining market share. The use of higher-potency cannabis products is likely to increase exposure to THC, which can increase the risks of adverse mental and physical health effects. Two recent studies (one examining emergency department visits in Ontario, and another examining hospitalizations in Alberta, British Columbia, Ontario and Quebec) describe increases in the rate of health care incidents for cannabis-related psychosis coinciding with the legal sale of additional classes of cannabis products (that is, cannabis extracts, edible cannabis, cannabis topicals) and commercial retail expansion. Footnote 16 , Footnote 17 Additional research is needed to investigate the relationship between the use of higher-potency cannabis products and cannabis-related harms, including psychosis.

We also note that while certain synthetic cannabinoids (for example, spice) are controlled by the Controlled Drugs and Substances Act and not by the Cannabis Act , they could pose a problem in the future and should be monitored.

Interventions to address high-potency products and novel products

We deliberated extensively on the topic of higher-potency cannabis products, taking into account all the evidence available, the data gaps and the differing points of view. Like the Task Force, we had to contemplate the unintended consequences of possible measures, including product regulation to limit THC quantities or concentrations in different cannabis products.

Ultimately, we feel that at this time, the best course of action is a combination of measures that aim to nudge consumers away from higher-potency cannabis products, while supporting research to better characterize the risks associated with these products and their use. First, research on the health effects of high-potency products and novel cannabinoids is necessary to further characterize the health consequences for different subpopulations. Footnote 18 Second, consumers need to be provided with options to choose lower-potency products, and with better information about the risks posed by high-potency products and novel cannabinoids. Third, Health Canada should exercise vigilance in its review of new cannabis product notifications to ensure the current rules are being followed. Finally, if the current trend toward higher-potency cannabis cannot be halted or reversed through labelling, consumer information, price disincentives and moral suasion (discussed below), then more aggressive product regulation should be considered. In Chapter 8, we offer a recommendation to use tax policy to encourage lower-risk cannabis consumption, calling on Finance Canada to consider applying progressively larger duties on cannabis products with higher quantities or concentrations of THC (or other intoxicating cannabinoids).

Advancing research on high-potency and novel products

Determining the appropriate interventions to address high-potency and novel products requires a better understanding of the effects of these products. However, research has not kept pace with the evolution of cannabis products, nor with changes in cannabis-related behaviours. The Government of Canada should provide adequate and ongoing support for research on the health effects of high-potency cannabis products and novel cannabinoids. There are many unknowns about certain cannabinoids (such as intoxicating cannabinoids like cannabinol [CBN] or delta-8-tetrahydrocannabinol), combinations of cannabinoids and formulations that are intended to increase the intoxicating potential of products (such as those that are "fast-acting"). In view of emerging concerns about increased use of higher-potency cannabis products and the corresponding health consequences, it is important that current gaps in knowledge be addressed through timely investment in research.

Providing consumers with information and lower-risk options

Steps should be taken to increase consumer awareness about the potential risks of consuming large quantities of THC, and to assist consumers in making decisions about lower-risk cannabis use. We see merit in establishing an appropriate definition for high-potency products and implementing 1 or more new health warning messages to inform consumers about the elevated risks of these products. Other labelling initiatives, including the establishment of a standard dose discussed later in this chapter, may also help to convey the intoxicating potential of a given product to consumers and nudge consumer behaviour towards lower-potency and lower-risk products. We advise Health Canada to think carefully about the terminology in this area, and in the design of any additional labelling, to avoid any unintended consequences where these measures become a promotional tactic for companies attempting to promote the THC content of their product, or to imply that lower-potency products are "safe".

While Health Canada regulates the production of cannabis, it does not control the purchasing policies of provincial and territorial distributors or the product mix that is made available to adult Canadians in legal retail stores and online. Footnote 19 We appreciate that distributors and retailers aim to meet customer demands; however, we would like to see distributors and retailers take steps to diversify their product offerings to include a greater selection of lower-potency cannabis products. This may nudge consumers to choose lower-potency cannabis products.

Monitoring the introduction of new cannabis products

The federal cannabis compliance and enforcement framework enables surveillance and provides tools to take action to address issues with products already on the market (such as warning letters, public advisories, product recalls, administrative monetary penalties, licence suspensions and licence revocations). There are a number of legislative and regulatory requirements that licence holders are subject to, including restrictions on the use of certain ingredients. However, we believe that Health Canada needs to be more vigilant in monitoring new products and should be ready to implement new controls where necessary to address innovations that increase risks to health. The recent example of companies formulating products with intoxicating cannabinoids other than delta-9-THC is a case in point. Health Canada should determine whether regulatory controls that are currently specific to delta-9 THC (for example, the maximum quantity or concentration of THC in a product) should be modified to include other cannabinoids as well.

Stand ready to introduce product regulation

If the current trend toward higher-potency products and their resulting harms continues, we would encourage Health Canada to examine measures that would place more restrictive limits on the cannabinoid content of legal cannabis products, or to implement additional limitations on the appeal of these products (for example, prohibiting flavours). If additional restrictions are contemplated in the future, Health Canada should recognize that regulatory measures that limit or prohibit consumer access to products that have been legally available may have the unintended consequence of pushing some consumers to the illicit market. To avoid unintended consequences, the introduction of any additional restrictions or prohibitions should be combined with enforcement and education strategies that address the supply of, and demand for, illicit high-potency cannabis products.

Maintaining the majority of promotion, packaging and labelling requirements, while improving certain aspects

In light of the concerning public health trends discussed in this chapter, there is a need to maintain the elements of the framework that protect youth from accessing cannabis, while providing adult consumers with information to make informed decisions.

We believe that the core elements of the framework dealing with promotion, packaging and labelling must be maintained to protect youth and non-consumers.

We acknowledge that there are areas where greater clarity can be provided to the industry about what is allowed, thereby providing more certainty for their promotion, packaging and labelling practices. There are also some adjustments to the regulations related to packaging and labelling that we believe can be made without posing undue risks. We address other potential adjustments to the regulations to reduce regulatory burden in Chapter 8.

Upholding promotion, packaging and labelling controls

The core promotion, packaging and labelling controls (such as limiting promotion to age-restricted environments, requiring plain packaging and prohibiting products that are appealing to youth) should be maintained to prevent inducements to use cannabis, particularly among youth. Footnote 20 Experience with the cannabis framework is limited, and lessons from tobacco suggest that robust controls are needed to protect youth and others from inducements to use addictive, mind-altering substances. While the Government of Canada should always be responsive to new evidence, maintaining the current controls is prudent at this time. In general, the evidence available to us suggested that the current regulations related to promotion, packaging and labelling do not compromise public health and public safety, although some stakeholders raised concerns to us about the use of company names to convey notions of wellness or lifestyle enhancement, which would otherwise be prohibited on product labels or in promotions.

Clarifying current restrictions and requirements

Some of the reforms requested by the cannabis industry on packaging and labelling relate to practices that do not actually contravene the current controls. These include presenting factual information on product labels about the product (for example, that a product was "sun grown" or "hand trimmed"). While changes that increase the appeal to youth or those who do not use cannabis should not be allowed, providing some additional information on a product's characteristics or its origin to people who use cannabis may help to reduce the emphasis on THC quantity or concentration as a marker of quality or value. Health Canada should provide clear guidance to industry on the promotion restrictions and packaging and labelling requirements to allow industry to communicate more effectively with consumers in age-restricted environments and on product packages, resulting in more informed consumer choice.

Improving health warning messages

While the key promotion and packaging and labelling restrictions should be maintained, improvements could be made to product labelling rules to convey health risk information. It is our view that health warning messages that relate to a specific route of consumption (for example, smoking) would be more effective if they appear on products that are consumed in that manner (for example, pre-rolled joints). However, some health warnings could continue to be applied to any cannabis product (for example, messages about the risks of using while pregnant). As well, there are some well-substantiated risks that are not included in the current health warning messages, including the risk of cannabis-induced psychosis and schizophrenia.

Health Canada should update the content of the health warning messages and commit to regularly revising them as new science emerges.

As Health Canada pursues reforms to health warning messages, it should engage with the research community to ensure that the content reflects the latest science, and that the approaches to messaging are as evidence-based, effective and impactful as they can be.

Making information on labels easier to understand

Both public health and industry representatives advocated for changes to the elements of the current framework that might be causing confusion for consumers. The framework lays out a series of requirements that are intended to provide adult cannabis consumers with accurate information on the products they consume. In their current form, the labels of certain cannabis products must display at least 8 numeric values: the quantity or concentration of THC per unit, the "total THC" per unit (taking into account the conversion of THCA into THC), the quantity or concentration of THC per package, the "total THC" per package, and the 4 corresponding values for CBD. Footnote 21 This can be difficult to interpret for some consumers and is an area where simplification may improve comprehension and support healthier decision-making.

Targeted changes to packaging and labelling

Industry representatives advocated for transparent windows in product packages, and on this matter some nuance seems appropriate. While we have great concern about a cut-out window for edible cannabis products (revealing gummies, cookies or brownies to children who might see the package), we do not have the same concern for dried cannabis products. A small cut-out window for dried cannabis products would allow consumers to see the plant material before they purchase the product, which may aid in shifting the perception of high THC quantity or concentration as the primary marker of quality.

Industry stakeholders advocated for regulatory changes that would provide consumers with more information about the product. Such information would need to be consistent with the restrictions and requirements in the Act and the regulations with respect to promotion, packaging and labelling. For example, we received suggestions for regulatory changes that would allow for the use of certain symbols (such as organic certification or recycling) on product labels.

Some latitude in this regard may help reduce the focus on THC quantity or concentration as the primary product characteristic or indication of quality, while providing factual information to consumers.

Industry stakeholders also advocated for the ability to use "QR codes" on product labels. Examples of information that could be accessed via a QR code include: the quantity or concentration of other cannabinoids, terpene profile, analytical testing results and production practices (such as "sun-dried" or "organically grown"). Footnote 22

Some Panel members expressed concern about the potential for QR codes to increase the exposure of youth and non-consumers to promotions. These Panel members were concerned that such a change could lead to unsolicited promotions or online marketing. These members suggested that, if adopted, the outcomes of the change should be closely monitored for unintended consequences and reversed if evaluation suggests any unintended harms.

A majority of the Panel was in favour of the use of QR codes to provide the type of factual information described above as a way to reduce the focus on high THC content as the key characteristic of a cannabis product. They felt that the issue of online targeting of youth or new consumers is a serious one, but that the use of QR codes would not materially contribute to the problem.

Moving toward a standard dose

We also see the need for a simpler way to communicate a "standard dose" or "unit dose" to cannabis consumers, to help convey the amount of a product that should be considered a single serving. This could be an effective nudge for cannabis consumers to move towards lower-risk cannabis use behaviours, through clearer communication and messaging. The concept of a standard dose for cannabis has been elusive for several years due to the complexity of establishing comparable units in different product classes, as well as the large individual differences in how cannabis can be consumed, metabolized and experienced. Nonetheless, this initiative could facilitate additional research on cannabis and its effects. Health Canada should undertake the research and consultation necessary to move forward with the establishment of a standard dose and corresponding labelling requirements.

Enhancing regulatory compliance and enforcement

Another important aspect of labelling is the accuracy of the information presented. Several stakeholders raised concerns about "lab shopping", where claims about the THC quantity or concentration of a product are inflated as part of an effort to appeal to consumers seeking higher levels of THC. While there would be some benefit from additional empirical data to help characterize the extent of the issue, a product should contain, within reasonable variances, what the label says it does. The Act already includes provisions that prohibit false or misleading claims; these measures do not appear to be enforced in the context of inflated claims about THC content. Health Canada should take steps to remedy the issue through regulatory enforcement.

We appreciate the need for product and brand differentiation in a competitive market and believe that some degree of promotion could be beneficial to reduce the focus on THC quantity or concentration as one of the markers of a product's characteristics. Promotional activities that would comply with the current rules and that might be helpful to adult consumers could include in-store displays of information about how products from a particular company were produced (for example, "hand trimmed") or where they were made. Such information could also be displayed on product labels to help adult consumers differentiate between products and brands.

Health Canada explained that it conducts some monitoring of the promotional activities of cannabis licence holders and other regulated parties (for example, authorized retailers), largely based on complaints it receives (for example, lifestyle promotion, promotion that is appealing to youth), and that some compliance and enforcement activities have occurred. But often non-compliance (such as engaging in prohibited promotion practices) results only in warnings without meaningful penalties. Since the department continues to receive information on examples of activities that are non-compliant, this suggests that warnings are not sufficient. We also encountered examples of non-compliant advertising and promotional activity, which raises concern about the effectiveness of the current approach to enforcement. In future, Health Canada should be vigilant and consider more decisive enforcement actions against those engaging in prohibited cannabis promotions, including issuing administrative monetary penalties and revoking the licences of those that repeatedly or egregiously violate promotional restrictions.

No one we met with advocated for promotion outside of age-restricted environments. We feel strongly that age-restriction is a measure that must be maintained. However, there is a marked difference between approaches to verifying age in physical stores and online. It appears that, for the most part, brick-and-mortar retailers are adequately enforcing age requirements.

On the Internet, it is a different story. The current approach to verifying age in most cases (that is, ticking a box to confirm the purchaser is over the age of majority or inputting a date of birth to gain access to a website) is weak and ineffective. While the issue of online age verification is not unique to cannabis, measures should be explored to make it harder for youth to access cannabis websites and social media platforms where cannabis is promoted. Private companies and Crown corporations (that is, distributors and publicly-owned retailers) operating in the legal cannabis market should do more than require "click yes to enter" or "enter a birth date". Examples of age verification strategies include validating identification documents or cross-checking consumer details against third-party data from public databases.

We recognize that there are broader issues involving the protection of minors online, which may warrant attention and collaboration by regulators and enforcement agencies. We also recognize that the most egregious promotions are typically posted by illicit players, and there are challenges associated with finding and identifying unregulated parties. We discuss these matters further in Chapter 10.

Chapter 7: First Nations, Inuit and Métis

We were given a mandate to consult broadly with First Nations, Inuit and Métis on the impacts of cannabis and the Cannabis Act (the Act). We took a distinctions-based approach to our meetings, understanding that each community had specific concerns and experiences related to cannabis and its legalization. Footnote 1 We would like to thank everyone we met with for sharing their time and answering our questions.

We acknowledge that some of the recommendations we are making relate to shared priorities for First Nations, Inuit and Métis, but we emphasize that they should be adopted and implemented through a distinctions-based approach that includes nation-to-nation consultations. We also recognize that some of these recommendations may not be applicable to all communities.

While the Act represents a paradigm shift in the government's approach to cannabis, for many First Nations, Inuit and Métis leaders, it is a reminder of the systemic barriers they face in their dealings with governments. A common theme we heard throughout our consultations was a sense of frustration with the lack of opportunity to provide input into the design of a legislative framework that would have a profound impact on their peoples. While the Act defines the authorities of the federal government and provincial and territorial governments, it is silent on the authority of First Nations, Inuit and Métis governments with respect to cannabis.

First Nations, Inuit and Métis leaders and communities have responded to the public health and public safety concerns related to cannabis and cannabis legalization using the resources, tools and law-making authorities they have at their disposal. These responses range from efforts to fully prohibit cannabis within their territory, to operating within federal, provincial and territorial legislative frameworks, to establishing their own laws and governing bodies to oversee production and retail sale, consistent with their expression of their inherent rights and sovereignty.

In developing our advice, we considered the recommendations of the Standing Senate Committee on Indigenous Peoples (the Standing Senate Committee) report On the Outside Looking In: The Implementation of the Cannabis Act and its effects on Indigenous Peoples and have included reference to them where applicable. We also considered findings from Health Canada's Summary from engagement with First Nations, Inuit and Métis Peoples : The Cannabis Act and its impacts .

Our overall assessment is that there are significant gaps in the cannabis framework that negatively impact the public health, public safety and equitable treatment of Indigenous communities and individuals.

We heard concerns from Indigenous leadership about the absence of any authority in the Act for Indigenous communities to govern activities relating to cannabis in their communities. Other issues raised by First Nations, Inuit and Métis Peoples include:

• insufficient and outdated research on the impact of cannabis on First Nations, Inuit and Métis
• lack of investment in culturally appropriate public health interventions (for example, harm reduction, mental health and prevention) and in culturally appropriate information about cannabis
• the proliferation of unauthorized retail stores in some First Nations communities (that is, stores operating without approval from community leadership, or without provincial or territorial authorization)
• inadequate ability to address criminal activity in communities
• barriers to participating in the legal cannabis market

We understand that issues related to cannabis legalization and the control of cannabis-related activities are linked to broader issues of self-determination and reconciliation. We also recognize the Government of Canada has made a commitment through the United Nations Declaration on the Rights of Indigenous Peoples Act to take measures to ensure the laws of Canada are consistent with the United Nations Declaration on the Rights of Indigenous Peoples . Over the long-term, we expect the broader effort to implement the Declaration to include consideration of cannabis and resolve what self-determination means in the context of cannabis. This will be important work, and we encourage public health and public safety considerations to be at the forefront. This work may lead to significant changes; in the meantime, action is needed now to help communities address the situation on the ground.

Given this context and the public health and public safety challenges that are present in Indigenous communities, notably First Nations communities, it is clear to us that changes are required. We also see these changes, and others, as providing better opportunity to support participation in the legal market, and thus economic development in communities.

This chapter makes recommendations that aim to improve outcomes in 3 areas: health (including public health and mental health); public safety and law enforcement; and economic participation.

Our recommendations depend on appropriate resources being in place to be effective. Interested First Nations, Inuit and Métis should have the funding necessary to be full partners in working to make the recommended amendments to the Act and to build the capacity to take on the responsibility of overseeing commercial cannabis activities in their communities, alongside supports for public health interventions and police services, to better protect public health and public safety.

Investing in health, public health and mental health supports, and research

There are already significant demands on health, public health and mental health services in many First Nations, Inuit and Métis communities. We acknowledge that the capacity and resource issues in these areas are broader than the scope of our review; however, they cannot be disregarded as they are interconnected with cannabis legalization.

Many communities are dealing with a multitude of health and public health challenges, including mental health issues, polysubstance use and problematic substance use (including the use of cannabis). In addition, experiences of discrimination, racism and intergenerational trauma arising from Canada's history of colonialism continue to affect the health of First Nations, Inuit and Métis. These challenges require an integrated approach to provide effective health services that are culturally appropriate and trauma-informed, including prevention interventions and treatment supports. Footnote 23

Supporting the development of distinctions-based, culturally appropriate research and health information

We understand that many communities are seeking more resources and supports to lead their own research and surveillance activities, as the Standing Senate Committee also noted. We recommend that research about the impacts and effects of cannabis and legalization on First Nations, Inuit and Métis be Indigenous-led. The research must reflect the priorities of First Nations, Inuit and Métis communities and recognize data sovereignty and ownership.

Distinctions-based, culturally appropriate cannabis information and education efforts are critical, and must consider the knowledge and experience that exists in communities . Generic public information materials are often not reflective of the reality in First Nations, Inuit and Métis communities, nor based on evidence or data that included adequate First Nations, Inuit and Métis representation.

Some First Nations, Inuit and Métis organizations have developed their own culturally appropriate public information material. For example, Pauktuutit Inuit Women of Canada published Let's Talk About Ujarak: a Cannabis Harm Reduction Toolkit , which was guided by Inuit values and created to help Inuit increase their knowledge about cannabis use and how to reduce harms. These types of resources are important and needed; Health Canada should commit to co-developing them on a distinctions-basis with First Nations, Inuit and Métis.

The Manitoba Métis Federation indicated that their priorities continue to be focused on the protection of public health and public safety. We heard very clearly that research, education and interventions for Red River Métis must always be Métis-specific and developed and informed by consultations with communities.

Defining cannabis as an "intoxicant"

An important element in giving communities control over public health and public safety is the opportunity to prohibit the possession or sale of cannabis for non-medical purposes. While the Indian Act allows First Nations governments to ban alcohol, this is not the case for cannabis. This could be remedied with a simple amendment to the definition of "intoxicant" in the Indian Act.

Community public safety and enforcement

The rise in cannabis retail stores not sanctioned by communities operating on Indigenous land, largely First Nation reserves, is a significant problem. We heard and saw first-hand how these stores, some of which we understand are supported by criminal organizations from outside the community, have taken advantage of the jurisdictional complexity associated with legalization to operate against community wishes and without any protection for public health and public safety. These stores sell products that do not comply with product, packaging or labelling rules, creating public health risks for both residents of the community and those from outside the community who purchase the products. Community leadership also told us that these stores present significant public safety challenges, given the amount of cash involved on site and the actors who support the operation of the stores.

It must be emphasized that these unauthorized stores are different than stores that are sanctioned by community leadership. Stores sanctioned by the community may be operating outside of the provincial or territorial frameworks, but we understand that in these cases, the communities largely have the same public health and public safety objectives as in the Act . We saw several examples of community laws that articulate this commitment to public health and public safety and heard from some communities about the steps they have taken to set up licensing and oversight bodies. From our perspective, the real concern is retail outlets on Indigenous territories that are operating without any authorization and that may be affiliated with organized crime groups.

While communities are often supportive of enforcement actions being taken to disrupt unsanctioned, illicit operations on reserve, police actions have been limited. Given the large number of these stores in some communities, First Nations community leadership expressed fears about the prospect of never seeing change. They noted that their own police services do not have the capacity to tackle the problem and that there needs to be more assistance from and coordination with other police services such as the Royal Canadian Mounted Police or provincial police services. As a result, public health and public safety risks continue to grow unchecked.

Support for enforcement

We believe that recognition of community authority to control cannabis activities would help to address this challenge, since it would draw a clear line between authorized and unauthorized activities and provide clarity for enforcement purposes. We also recognize that First Nations police services must contend with many priorities, similar to other police services. They also face the challenge of operating in a context of time-limited and insufficient funding, as well as more limited access to training and other supports. Inadequate resourcing and training of First Nations police services is not restricted to enforcement of the Act. However, the lack of progress in this area negatively impacts public safety in First Nations communities.

We also note the recommendation from the Standing Senate Committee that the Royal Canadian Mounted Police provide dedicated space for First Nations police services to undertake Drug Recognition Expert Training, and that Public Safety Canada provide additional funding to First Nations to support this work to address cannabis-impaired driving.

Where First Nations communities do not have their own police services, we believe there should be further training for the non-Indigenous police services in relation to First Nations community laws and bylaws to better support their enforcement. We encourage these police services to prioritize building relationships with the First Nations communities within the territories where they work.

Longstanding challenges to public safety in Indigenous communities will require sustained attention by all governments and the development of strategies in collaboration with Indigenous leadership. They include training and capacity building for community police services, better coordination with non-Indigenous police services and with Crown prosecutors, and greater priority given by all governments to public safety in Indigenous communities. All of these issues need to be addressed; failing to do so will mean there is unlikely to be any improvement in public safety generally, nor specifically in relation to criminal activity with cannabis.

Economic participation

Throughout our discussions, many First Nations representatives expressed disappointment in the lack of opportunity to participate in the legal cannabis industry, noting that governments missed an opportunity to advance economic reconciliation by bringing jobs and tax revenue to communities.

We heard from many First Nations leaders and entrepreneurs and some Métis individuals who are interested in participating in the cannabis industry. Some view the ability to have commercial cannabis activity within communities as an important element of economic reconciliation and a means to create a more equitable industry. Others felt that the establishment of legitimate retail outlets would help counter the proliferation of illicit operations in their communities, many of which have links to organized crime.

We believe there are 2 approaches to improve economic participation. First, more support should be provided for those interested and willing to participate in the existing licensing frameworks. There should also be authority under the Act for nation-to-nation agreements that would provide greater community control of commercial activities with cannabis. This second approach would require the Government of Canada to collaborate and co-develop these legislative amendments with First Nations, Inuit and Métis, with the aim of enabling agreements that provide for Indigenous government authority. This would require agreement on requirements or standards that protect public health and public safety. This work would also require the parties to answer important questions including: the degree of harmonization between federal, provincial and territorial requirements and Indigenous government laws, responsibility for enforcement of Indigenous laws and how to best address illegal activity that harms Indigenous communities.

Economic participation in cannabis production via federal licensing

Some communities have made the decision to participate in the framework under the Act and acquire federal licences to produce cannabis. As of September 2023, there were a total of 907 licence holders authorized to cultivate or process cannabis, of which 50 (6%) were self-identified Indigenous licence holders. Footnote 24 However, similar to others in the industry, Indigenous entrepreneurs and leaders told us there are many barriers that impede them from successfully participating in the legal industry as federal licence holders. These issues include:

• financial barriers to entering the legal industry, including difficulties in accessing capital to build a site
• competition from the illicit market
• regulatory burden of information requested by Health Canada and the Canada Revenue Agency related to licensing and excise tax licensing
• issues related to accessing basic business services, such as banking and insurance
• challenges selling product to provincial and territorial distributors (for example, volume requirements from distributors, reliance on competitors to sell product to distributors and restrictions on cultivators from selling dried cannabis directly to distributors)

Health Canada must take immediate steps to address these issues to better support those who wish to participate in the federal framework. Chapter 8 lays out a series of recommendations that could apply to Indigenous federal licence holders. These include possible revisions to regulatory fees charged to equity-deserving licence holders and micro-licence holders, providing these applicants with information on grants, loans and other programs that may be available to them, and offering post-licensing supports to help them navigate regulatory compliance and other business responsibilities.

We note that Health Canada provides certain services to support Indigenous applicants in navigating the licensing process under the Act, including a Navigator Service, a Licensing Advisor and a 2-stage review process. We understand that the Navigator Service, which supports general inquiries about licensing, has helped nearly 170 self-identified Indigenous-affiliated commercial licence applicants since 2017, while the Licensing Advisor, who provides more detailed application development support, has only had 2 clients. Footnote 25 The 2-stage review process allows Indigenous and Indigenous-affiliated applicants to have their applications reviewed before requiring a built site (which is a requirement for all other applicants). This allows for early feedback on an application and is intended to help facilitate access to capital to finance site construction.

Economic participation in distribution and retail

As noted in our What We Heard Report , a February 2023 article in an industry periodical suggested that less than 1% (24 of more than 3,300) of the provincially or territorially authorized retail stores were operating on First Nations reserves. Footnote 26

We heard from some communities that they are interested in obtaining provincial or territorial licences to operate retail stores. British Columbia, Ontario, Quebec and Saskatchewan have enacted legislation that provides authority for the government to enter into agreements with First Nations to sell cannabis on their territories. However, as the Standing Senate Committee report points out, some First Nations expressed concerns that participating in provincial licensing regimes can be costly. We also learned from some communities that there are inadequate incentives to enter into such agreements (for example, they do not get any discounts on licensing fees or product mark-ups) and that they are still required to participate in a provincial licensing process (Saskatchewan's legislation is the exception, as it allows First Nations to establish their own licensing regimes).

In provinces and territories where there is public control of retail sale, there appears to be less progress towards arrangements for First Nations retail. As an example, a First Nations community in Quebec expressed concern that if the provincial government does not provide regulated retail access to community members, illicit sales will proliferate, along with the attendant harms from illicit products (that is, products that do not comply with the product, packaging and labelling rules posing health risks and the potential for more dangerous criminal activity posing public safety risks).

Indigenous jurisdiction and control of cannabis activities in Indigenous communities

There is no one-size-fits-all approach. As noted above, some communities simply want the authority to prohibit activities related to cannabis for non-medical purposes in their communities, including prohibiting commercial activities. Others are prepared to work within federal and provincial and territorial frameworks. Some want to assert full control.

Certain communities have created their own cannabis frameworks, including their own cannabis laws. We understand that these generally reflect the public health and public safety requirements and product standards found in federal, provincial or territorial laws. We reviewed some examples, including from Six Nations of the Grand River and the Mohawk Council of Akwesasne. Some of these communities have developed their cannabis frameworks as an assertion of their inherent rights and reject the need for federal, provincial or territorial licences. Others have done so due to provincial or territorial unwillingness to authorize retail stores in their communities.

Despite being lawful from the community's perspective, the lack of recognition of First Nations, Inuit and Métis authority under the Act means that production and sale activities conducted pursuant to these, or other, community laws are not legal under the Act and may result in legal challenges for those engaging in them.

Notwithstanding the desire of these communities to protect public health and public safety, there are questions about the quality of the products being sold and the health risks they might pose (for example, being contaminated with pesticides), given that community-sanctioned retail stores cannot access cannabis from federal licence holders or testing from licensed analytical testing companies. The lack of recognition of First Nations authority also limits the ability of the communities and entrepreneurs involved to be recognized as legitimate businesses by banks, insurance companies and others. We believe that these public health and public safety issues, and others, can be better addressed by providing for greater Indigenous community control under the Act.

Providing for greater Indigenous community control under the Cannabis Act

The issue of bringing the Act into compliance with the United Nations Declaration on the Rights of Indigenous Peoples needs to be addressed, but this will take time. However, there are pressing public health, public safety and economic equity reasons for acting now to provide more control to Indigenous communities over economic activities involving cannabis. This would require amendments to the Act to create a viable pathway for interested First Nations, Inuit and Métis communities to assume more control over commercial cannabis activities. This work would need to include a process to develop, with First Nations, Inuit and Métis, requirements or minimum standards to protect public health and public safety (for example, the types of products that could be made and sold, the testing standards for cannabis products, the minimum age to purchase cannabis and measures to protect against diversion to the illicit market). One of the issues to be determined is what role the provincial and territorial governments would have with respect to the development of these standards.

One promising approach is that taken by the Government of Saskatchewan. In 2023, it amended its Cannabis Control (Saskatchewan) Act to create a legal framework for First Nations in Saskatchewan to licence and regulate the distribution and retail sale of cannabis on reserve. By having an agreement with the provincial cannabis authority, a First Nations cannabis authority can issue permits for the sale and distribution of cannabis on reserve, including charging fees and setting terms and conditions for permittees. The Saskatchewan legislation sets out mandatory requirements for these permits (including that the cannabis sold or distributed must be supplied by a federal licence holder, that there be no sale to minors, that there be appropriate records of their activities and that they take adequate measures to protect against diversion of the cannabis to the illicit market). We note these are the same measures set out in section 69 of the Cannabis Act that provinces and territories must apply to authorized sellers. We encourage Health Canada and Indigenous leadership to review the agreements implemented as a result of this legislative change in Saskatchewan. As this is a cannabis-specific development, it may prove useful as a positive step to provide greater control.

Recent federal legislation on child welfare and on drinking water, co-developed with First Nations, Inuit and Métis and which address recognition of Indigenous authority and rights, are examples that could be useful for considering how to address cannabis in the context of the United Nations Declaration on the Rights of Indigenous Peoples . Footnote 27 , Footnote 28 A recent decision by the Supreme Court of Canada upheld the constitutionality of the child welfare legislation, and noted that the effort to "braid" together the legislative authority of Indigenous Peoples, the international standards in the Declaration and the provisions enacted by Parliament on national standards or principles provided "a framework for reconciliation when it comes to Indigenous child and family services, in the spirit of the Declaration". Footnote 29

The Supreme Court's language on the development of the national standards or principles in relation to child welfare has resonance when it comes to thinking of an approach to developing public health and public safety standards for cannabis in the context of nation-to-nation agreements. The Court makes it clear that Parliament's intention with respect to national standards was not to impose them unilaterally, without regard to the perspectives of Indigenous groups, communities or peoples. Rather, it said the Government of Canada committed to engaging with Indigenous peoples and provincial governments to support a comprehensive reform of child and family services that are provided in relation to Indigenous children.

Taxation and revenue sharing

The question of authority over taxation was one that the Standing Senate Committee heard about, and an issue that arose repeatedly in our engagement with Indigenous communities, particularly First Nations communities, who also shared a variety of preferred approaches. The range of positions is captured in Chapter 7 of our What We Heard Report : "While select First Nations governments have negotiated agreements to allow them to control the sale of cannabis, they are still required to collect sales tax for other levels of government. Many continue to advocate for arrangements in which they would receive all, or a share of, cannabis sales and excise tax revenues generated from within their communities in order for the revenues to be reinvested. Some seek tax-sharing agreements with federal or provincial and territorial governments, while others seek amendments to tax laws to provide opportunities for interested First Nations to levy their own cannabis excise tax in their communities. Many argue that federal or provincial and territorial sales tax revenue should be directed back into their communities."

Successful implementation of the cannabis control framework depends on many factors, including a reliable supply of regulated, quality-controlled cannabis. While the Cannabis Act (the Act) does not explicitly list ensuring the viability of the industry as an objective, the commercial production model implemented via the Act relies on financially viable private sector participants to supply the legal cannabis market.

Throughout our review, industry representatives raised urgent concerns about their financial viability in the current highly competitive market. We believe these concerns are well-founded; however, we are of the view that efforts to support the industry need to be done in a manner consistent with the overarching public health and public safety objectives of the Act.

Notwithstanding the difficulties faced by individual licence holders, experience to date suggests that, overall, the market share of legal cannabis has increased substantially over time and compares favourably with U.S. states that have legalized cannabis. Displacement of the illicit market is discussed further in Chapter 10. There are a wide variety of legal cannabis products available through retail stores and websites. While there are price differences between legal and illicit cannabis, and displacement of the illicit market differs regionally, the data available to us suggests that the gap has narrowed, and cannabis consumers are increasingly acquiring cannabis from legal sources.

Creating economic conditions for a viable cannabis industry

Challenges for smaller licence holders.

Cannabis is not like other products; a large illicit cannabis market existed in Canada before legalization, and that history, and the people that were part of it, must be factored into the continued implementation of the Act. Through the cannabis framework, the Government of Canada sought to encourage a diverse, competitive market, with smaller and larger players distributed across the country. We understand that through the creation of "micro" class licences and other measures, the federal government had hoped to facilitate the transition of individuals who had been involved in illicit cannabis production (but without links to organized crime or histories of violent criminal activity) into the legal cannabis market. Footnote 30

In principle, small-scale cultivators and processors distributed throughout the country could increase consumer access to a greater variety of cannabis products (for example, "craft" products manufactured by small, local businesses, more opportunities for innovation). In practice, however, the majority of micro-class licence holders appear to be struggling to gain a foothold in the legal market.

It will be very challenging for smaller companies to succeed without some government intervention and measures that provide some specific advantages or flexibilities. Over the last 18 months, we met many people from the cannabis industry who exhibited an obvious passion about the quality of their product and a clear desire to participate in the legal industry. In the best-case scenario, the legal market might provide these individuals with an opportunity to find a niche for themselves and their businesses. But we fear it currently does not. If barriers to success are not addressed, many small legacy producers will see no advantage to joining the legal market, and some of those who have done so may decide to return to the illicit market.

Current market conditions

Cannabis companies of all sizes are struggling. The last 5 years have been a tumultuous period for participants in the legal cannabis market. The market today is crowded, and production capacity greatly exceeds demand. Without material changes in the economic conditions, it is reasonable to anticipate that some portion of the current cannabis businesses will continue to downsize or cease operations. Depending on the extent of this shift, the diversity of cannabis products offered in the legal market may decrease while prices may increase.

It is clear that excess production and over-supply have contributed to decreased wholesale prices (that is, the price paid by provincial and territorial distributors to licensed processors). Canada has among the lowest cannabis prices in the world. Low prices have economic consequences for participants in the legal market as well as health consequences for consumers. There is concern that a market with abundant, cheap cannabis will likely contribute to increased cannabis consumption and exacerbate the negative public health impacts.

Over-supply is not the only issue. In the current model, there are many sellers (that is, licensed processors) and few buyers (that is, distributors). Provincial and territorial distributors hold a great deal of influence over the success of prospective suppliers, as they are the main purchasers of cannabis. Provincial and territorial distributors must make choices about how they operate, and in most jurisdictions they have exercised their monopsony power (that is, being the sole buyer in a market) in a way that we see as detrimental to those licensed by Health Canada to make and sell cannabis. This scenario, where provincial and territorial distributors can dictate terms, often leads to adverse effects, including lower prices for cannabis producers, reduced incentives for innovation and an overall imbalance in the bargaining power between distributors and producers.

That said, we recognize that distributors cannot reasonably purchase cannabis from every company that has a product to sell. The large number of cannabis licence holders vying for market share also contributes to the challenges being experienced by those operating in the legal market. Consolidation may lead to business failures, investment losses and job losses, which are all regrettable for those affected.

Our review of the Act reflects a particular point in time in a market that is continuing to evolve. We encourage the Government of Canada and its provincial and territorial partners to closely monitor the financial health of the cannabis sector. The Cannabis Industry Forum established by Innovation, Science and Economic Development Canada may provide an important venue for continued discussion of the factors affecting the viability of the legal cannabis market. As the market and consumption patterns continue to change, the framework will need to evolve to keep pace.

At the present time, Canadians spend more than $5 billion per year on legal cannabis. Footnote 31 This level of revenue should be sufficient to support a robust domestic market, albeit with no guarantees that every company that chooses to enter the market will be viable. Currently, cannabis revenues are not divided in a way that allows licensed cultivators and processors to be consistently profitable. In particular, smaller licence holders appear to be struggling as they cannot compete with larger companies on price and have less ability to secure shelf space with provincial and territorial distributors (who often look for large quantities of product).

Reducing regulatory burden on industry

Health Canada can, for its part, reduce the financial and administrative burden it places on participants in the legal industry. The department recently consulted on potential regulatory streamlining. If implemented, this initiative would have benefits in reducing the costs of compliance for licence holders and the regulatory costs Health Canada seeks to recover through fees charged to licence holders. As Health Canada and the regulated industry have gained experience with the framework, it appears to us that there is room to relax or update certain regulatory requirements without compromising public health or public safety.

For example, we suggest that current personnel security requirements might not be needed for some types of employees, some controls related to physical security may not be essential (such as visual monitoring of areas not in use), and some record-keeping and reporting requirements could be streamlined (such as harmonizing reporting between Health Canada and the Canada Revenue Agency to avoid duplication, reducing the reporting burden for some lower-risk activities such as waste and destruction, and reducing the length of time required to store certain records, especially visual records). Footnote 32

Measures to support cultivators and processors

Cultivators are currently not permitted to sell cannabis directly to provincial and territorial distributors. Rather, they must engage a processor to package and label the cannabis. As part of the regulatory streamlining amendments, we advise Health Canada to allow companies holding a cultivation licence to sell dried or fresh cannabis (that complies with all requirements for packaging, labelling and quality control) directly to distributors. We feel that this is within the spirit and intent of the cultivation licence class; it would also remove an unnecessary step in the supply chain.

Reforms at the provincial and territorial level that accommodate additional direct-to-consumer sales outside of the physical retail environment may create opportunities for smaller cannabis cultivators and processors to establish a niche for their products and generate revenue. While assessing distribution and retail sale is beyond the scope of our review, we note how important direct-to-consumer sales are for craft breweries. To have a positive impact, we believe any province or territory that sees benefit in allowing direct-to-consumer sales (for example, farmgate programs, or mail order within a province or territory) would also need to allow cultivators and processors to retain a larger share of revenue (for example, reducing or eliminating mark-ups and fees). Footnote 33 Jurisdictions exploring direct-to-consumer sales should consider whether and how these programs could be targeted so that they support independent micro-scale licence holders (sometimes referred to as "craft" producers) and equity-deserving groups, to promote the market diversity that was envisioned at the time of legalization.

There is also an opportunity for provincial and territorial distributors to reserve space for and highlight products from small licence holders and those from companies owned by members of equity-deserving groups. We are aware of some initiatives of this nature (for example, British Columbia's Indigenous Shelf Space program) and think additional ones could be important to sustaining diversity in the legal cannabis market.

Excise tax structure

Industry players concerned about their own viability have called on the Government of Canada to reform the excise tax regime. Footnote 34 In particular, they are seeking relief from the minimum duty of 10% or $1 per gram, whichever is greater, on dried or fresh cannabis (as well as plants and seeds). Some industry players called for reform because the excise tax formula was set at a time when the price was much higher than it is today. Footnote 35 At current cannabis prices, the excise tax is a substantial burden. Industry representatives also questioned whether the excise tax is serving its intended purpose of moderating consumption, given that licence holders are largely bearing the cost rather than passing it on to the consumer.

The challenge of designing an effective tax regime under the highly competitive market conditions that exist today is that any reductions in the excise tax on dried cannabis would likely translate to reductions in the wholesale price (that is, the price paid to licence holders by provincial and territorial distributors) and the retail price (that is, the price paid by consumers). Given the priority we place on the protection of public health, we would not want to see further reductions in the retail price of dried cannabis in the legal market, nor would we want any changes to make it more attractive to purchase products in the illicit market. Any redesign of the excise tax framework for cannabis should keep these considerations in mind and will need to be evaluated regularly and adjusted depending on how the market reacts.

Addressing potency through a progressive tax

There is a trend in market data that is troubling from a public health perspective. It appears that more and more consumers are purchasing cannabis products with increasingly higher quantities or concentrations of delta-9-tetrahydrocannabinol (THC). Researchers and industry representatives told us that restrictions on labelling and promotion have led consumers to fixate on THC content as a marker of quality or value. Elsewhere in this report (Chapter 6) we outline recommendations to clarify the information that should be permitted on labels and in promotions and for targeted regulatory reforms that would allow licence holders to communicate factual information about their products. While we hope this nudges consumer behaviour and reduces the emphasis on THC, we also encourage Finance Canada to consider developing a progressive excise tax regime for all cannabis products that increases the amount of tax owed based on the quantity or concentration of THC (or other intoxicating cannabinoids). Products with lower quantities of THC should have less tax.

An ideal regime would disincentivize the manufacturing and sale of higher-risk products and incentivize the production of lower-risk cannabis products. For a reform of this type to disrupt the current trend toward higher-potency products, relatively higher taxes on higher-risk products would need to translate to higher retail prices; it would be ineffective if companies simply absorbed the added cost from the higher tax. Distributors would also have to pay more for higher-risk products, as would consumers. If this model were to be implemented, there would be a need for a monitoring mechanism to examine the extent to which consumers are moving to the illicit market to purchase lower-priced products. Such monitoring should also consider any impacts on the purchasing and consumption behaviour of youth and other population subgroups.

Improving transparency

The federal licensing program has resulted in an over-supply of cannabis in Canada and concerns about the financial viability of many licence holders. As of September 2023, 907 companies held federal licences for cultivation and processing. Footnote 36 While we understand the Minister of Health has the authority to place a limit on the number of licences issued, we heard little support for this kind of intervention. Such a measure could also lead to unintended consequences (for example, discouraging geographic and demographic diversity in the legal cannabis market). However, Health Canada should continue to closely monitor the state of the legal cannabis industry.

Licence applicants and licence holders would benefit from greater transparency about the state of the cannabis market. Health Canada should provide prospective licence applicants with data that would enable them to make informed decisions about the feasibility of entering the market.

There are other measures that Health Canada could take if over-supply threatens the viability of the industry (for example, production limits on standard class licences). However, this type of measure should be contemplated only after full consultation and consideration of any unintended consequences.

Reviewing the regulation of industrial hemp

Industrial hemp (that is, varieties of cannabis with 0.3% THC or less in their leaves and flowers) is also regulated under the Act. Representatives of the industrial hemp industry noted that while cannabis and hemp come from the same plant family, the products that result from their cultivation are entirely different and carry very different risks. They told us that the industrial hemp industry in Canada has been negatively impacted by the legalization of cannabis, with less industrial hemp production and sales today than in 2017. They advocated for a new approach to the regulation of industrial hemp that sees it treated as an agricultural commodity, with changes that would increase the maximum allowable limit of THC in industrial hemp and associated derivatives. The industry also raised other issues related to potential uses of industrial hemp (including industrial hemp-derived cannabinoids or biomass). Footnote 37

We did not have an opportunity to delve deeply into the regulation of industrial hemp, but we recognize this is a topic that deserves careful and detailed consideration.

Building social equity into the framework

While the Act does not contain any explicit social equity objectives, the Ministers broadened the scope of our review to include some social equity considerations. Clearly there were wide-reaching social impacts from the prohibition of cannabis and the discrimination experienced by some groups in the criminal justice system. In addition, we heard concerns about how the current regime has led to under-representation of equity-deserving communities in the cannabis industry and a lack of economic opportunities for some.

Researchers at the Centre on Drug Policy Evaluation recently published a report that reviews evidence and best practices in social equity from other jurisdictions with legal cannabis markets; we encourage policymakers to examine their report, A Roadmap for Cannabis Equity in Canada to Inform the Legislated Review of the Cannabis Act .

In our consultations, many equity-deserving individuals described how the legal cannabis industry is not inclusive. They expressed frustration about the barriers faced by entrepreneurs from their communities and the obstacles confronting community members already in the industry, including challenges with financing (such as raising affordable capital) due to current and historical discrimination.

Community representatives highlighted the limited diversity in leadership roles in the cannabis industry, and their belief that there is less minority representation in this industry than in others. Stakeholders noted that people who are Black, Indigenous and from other racialized groups were subject to discrimination under prohibition and continue to be disadvantaged and under-represented under legalization.

The following paragraphs make a number of recommendations aimed at improving social equity. The objective is to make progress in undoing decades of discrimination. This will require sustained commitment over many years. Therefore, it will be important that there be ongoing, long-term attention to social equity issues. We believe that the future independent reviews that we call for in Chapter 12 should explicitly provide for an assessment of the progress made in advancing social equity, both with respect to participation in the cannabis industry and in relation to addressing disparities in interactions with the criminal justice system related to cannabis.

Supporting a diverse legal cannabis industry

We support the Government of Canada's goal of having a diverse legal industry, specifically, one that creates space for women, racialized communities, 2SLGBTQIA+, First Nations, Inuit, Métis and those disadvantaged by the historical harms of cannabis prohibition. We believe that at the outset of legalization there was a missed opportunity to address the harms of prohibition. However, that should not prevent action now. The federal government has a role to play in encouraging the participation of marginalized and racialized groups in the industry.

The current market conditions, as discussed, are challenging for most involved in the industry. Equity-deserving applicants seeking to enter the cannabis industry need to be provided with appropriate information and support. In developing programs and measures to increase the participation of these groups in the cannabis sector, Health Canada and its partners should take a comprehensive approach that looks beyond the first step of issuing a licence.

Health Canada should develop a specialized program for applicants from under-represented communities that provides pre- and post-licensing supports. This should include information about opportunities other than cultivation and processing licences, such as licences for industrial hemp and analytical testing. Footnote 38 Acknowledging the submission by the Competition Bureau entitled Planting the seeds for competition: Competition Bureau submission to Health Canada and the Expert Panel to support the Cannabis Act legislative review , which dealt with this issue, we believe that Health Canada should consider whether the requirement that applicants for licences have a pre-built site could be eliminated for equity-deserving and small business applicants. Footnote 39

We heard about difficulties that equity-deserving groups experience when attempting to secure loans, given their lack of existing networks and relationships with banks, lenders and investors. Health Canada could do more to make these applicants aware of business supports (for example, grants or loans) that may be available to them from other government departments and agencies (for example, the Black Entrepreneurship Loan Fund). Footnote 40 Similarly, we heard about the challenges micro-class applicants face, such as limited access to capital, regulatory burdens and difficulties navigating the licensing process.

During the licensing phase, Health Canada should consider reducing the costs it imposes for equity-deserving and micro-class applicants, including by reducing or eliminating regulatory fees related to applying for a licence.

After licensing, Health Canada should take a broad view of the supports that can be offered, including raising awareness about resources or educational opportunities offered by other departments or organizations that may help licence holders establish and run their businesses. For Health Canada this could include reviewing the annual regulatory fees charged to licence holders and providing more dedicated training and support to assist companies to comply with the requirements set out in the Act and its regulations.

Social equity and the criminal justice system

Many community representatives voiced their concern that disadvantaged and marginalized groups, especially racialized groups, continue to be disproportionately impacted by over-policing and interactions with the criminal justice system because of disparities in cannabis enforcement. There are gaps in knowledge about the impact of cannabis on specific groups, and the extent of ongoing racial discrimination in law enforcement, particularly with youth. It is well understood that charges or convictions related to cannabis offences cause enduring adverse social outcomes, such as stigmatization, negative impacts on family structures, job losses, difficulties in securing employment and restrictions on travel and housing access.

As of August 1, 2019, a distinct application process was implemented for those seeking a record suspension for historical convictions for cannabis possession. Footnote 41 , Footnote 42 This process was meant to be fairer and to better ensure the reduction of stigma and barriers experienced by those with such convictions. With this new process there is no fee or waiting period before an application can be submitted for many individuals. While a small proportion of people have made use of this distinct application process, access to this stream is expected to improve, as Public Safety Canada has funded non-governmental organizations to help individuals apply, including assisting with compiling all necessary documentation. Footnote 43 This process is not automatic and applicants must submit an application along with required documentation, which can be a barrier; it is an improvement over the regular record suspension process. However, the revised program only applies to those solely with simple cannabis possession convictions. Individuals with convictions for other cannabis offences (for example, production) must apply through the regular process, with its attendant costs and waiting periods, which can be as long as 10 years.

An automatic record sequestration process will come into force in November 2024 that will address all simple possession offences for all controlled drugs and will apply even if there are other non-drug offences involved. Footnote 44 , Footnote 45 We are encouraged to hear about this development; however, this new process only addresses offences under the Controlled Drugs and Substances Act and not those under the Cannabis Act . It is our understanding that the new process will be reviewed in November 2026; we encourage analysis and scrutiny of the efficacy and outcomes of the new process as it relates to cannabis convictions.

Improving information about cannabis for equity-deserving groups

As discussed elsewhere in this report (such as in Chapter 6), Health Canada should ensure that it follows an evidence-based approach when disseminating information on cannabis use and the associated risks and harms to consumers, or the public at large. As equity-deserving communities have their own interests and needs, informational materials should be co-designed with the intended audiences. Informational and educational programs need to be fact-based, non-stigmatizing, culturally appropriate, regularly evaluated and adjusted accordingly.

Enhancing data collection

Our efforts to assess the social equity impacts of legalization were hindered by a lack of data. There is no systematic collection of data on the diversity of the cannabis industry. In some surveys and other information collected by government, key sociodemographic data (for example, ethnicity or race) has not been collected, or, in some instances where this information is collected, it is not adequately disaggregated in the analysis or reporting of findings (including population surveys, health data, and data collected on police-reported incidents and criminal charges related to cannabis). While some progress has been made in recent years toward disaggregating data, more progress is required, including making this data publicly accessible.

Improving the monitoring of environmental impacts

While the Act and its regulations do not have any explicit environmental objectives, the Ministers broadened the scope of our review to include environmental impact.

Although the environmental impact of cannabis was not raised often during engagement, some participants highlighted concerns about cannabis product packaging. They raised issues about single-use plastic packaging and the limited use of packaging composed of cannabis and industrial hemp plant by-products. We also heard about the high rates of energy required for indoor cultivation. Some stakeholders discussed innovative approaches to reducing the environmental footprint of cannabis cultivation, such as the use of organic and regenerative farming practices, using cannabis as a bio-accumulator to help remediate the soil, making use of solar energy and the secondary use of cannabis by-product waste.

It is difficult to comprehensively assess the environmental impact of the cannabis regime, given the lack of data available. However, cannabis cultivation, processing and distribution across the supply chain undoubtedly have environmental impacts, including energy and water consumption, greenhouse gas emissions, air pollution, cannabis-derived odours, packaging waste and disposal of vaping devices, among others.

One of the objectives of the Cannabis Act (the Act) is to provide adults who choose to use cannabis with access to a quality-controlled supply of strictly regulated, legally produced cannabis. The goal of legalization was not to increase the number of people using cannabis. Rather, it was intended to provide those who already used cannabis with a regulated supply, complemented by a range of measures (including promotion restrictions, plain packaging requirements, labelling requirements and dissemination of information) that sought to discourage youth, and those who do not use cannabis, from initiating use. Footnote 46

Access to legal cannabis has improved since the Act came into force in October 2018. While there were supply chain issues in late 2018 and early 2019, it now appears that most adult Canadians who wish to obtain cannabis are able to do so from legal sources.

The distribution and retail sale of cannabis is controlled by provinces and territories. It is apparent that physical retail stores are the dominant means by which consumers access legal cannabis; however, retail density varies across the country. Some stakeholders highlighted challenges faced in rural and remote communities, particularly in the North, where retail store access is limited to larger population centres. In addition, Inuit communities also face unique challenges in accessing legal product due to limited access to credit cards and the Internet to buy legal products online.

Another element of access is the ability for consumers to legally obtain different types of cannabis products. Since late 2019, licensed processors have been able to develop and sell a wide range of cannabis products, with a variety that is generally comparable to the illicit market. However, in balancing its public health and public safety objectives, the framework does not provide unfettered access to all possible forms of cannabis. For example, there are restrictions that prohibit the sale of cannabis products (and accessories) that would be considered appealing to children. In addition, the current regulations on edible cannabis products (for example, beverages, gummies, chocolate) set a limit of 10 milligrams of delta-9-tetrahydrocannabinol (THC) in a package to address concerns about over-consumption and accidental consumption. Other forms of cannabis are also subject to restrictions, such as the limits on the ingredients that can be used to make cannabis vaping products and cannabis topical products.

Perspectives on the THC limit for edible cannabis products

Throughout our engagement, we heard calls from industry, and some consumers, to increase the amount of THC permitted in edible cannabis products. This issue was raised frequently, and our own deliberations around this topic exemplified a broader debate about balancing the protection of public health with the desire to provide adults who use cannabis with legal access to the products they want.

The general view of industry stakeholders was that the objectives of the Act would be best served by raising the THC limit for edible cannabis. They believe that making more potent edible products available in the legal market would encourage further displacement of the illicit market, and as a result, a greater share of the edible cannabis would be in child-resistant packaging (which is a requirement for legal products). As well, they argue there would be a reduced presence of illicit edible products that mimic common candies and foods that are enticing to children, and consequently there would be fewer unintentional exposures to children. Industry representatives also stated that the potential risks to adult consumers would be reduced by shifting more consumer to the legal market because illicit products may be contaminated or contain extremely high amounts of THC (for example, products on the illicit market often claim to contain between 500 to 1,000 milligrams of THC).

Public health stakeholders, on the other hand, supported maintaining the current limit on the THC content of edible cannabis. The public health community argued that legal products are likely contributing to the observed increase in the frequency of unintentional cannabis poisonings among children (for example, they noted higher rates of pediatric exposures in jurisdictions with greater availability of legal edible products). Public health representatives were also concerned that a higher THC limit would increase the severity of these unintentional exposures to children, citing research that suggests the threshold for severe or prolonged adverse effects on young children is quite low (1.7 milligrams of THC per kilogram of bodyweight, or about 20 milligrams of THC for a toddler). Footnote 47

Representatives from the public health community also noted that under the current limit, the majority of edible cannabis products offered include multiple units in each package (for example, 2 units with 5 milligrams of THC each), and argued that these smaller portions send an important signal to adults about appropriate dosing. Some in the public health community stated that while they support measures to increase displacement of the illicit market, it is not justifiable to undermine public health controls to accelerate the transition to the legal market.

These are conflicting points of view from stakeholders, and there are also shortcomings in the available evidence. While there are studies demonstrating increases in the incidence of child poisonings (see Chapter 5 of our What We Heard Report , as well as a recent study by Varin et al.), there is limited information available on the origin of the cannabis products involved in these events, and whether homemade edibles, illicit edibles or legally produced edibles were involved.

There is also uncertainty about the level of demand in the market for legal edible cannabis products with more THC. Industry representatives pointed to the sale of ingestible cannabis extracts as evidence of demand, but tended to disregard the price differential between these products and conventional edible products and the role that a lower price-per-unit may play in driving demand for a lower-cost product. Footnote 48 Notably, unlike dried cannabis where legal prices are increasingly competitive with the illicit market, illicit edible cannabis products may be up to 90% cheaper than legal products. Price will remain an important consideration for some consumers who are purchasing larger quantities or seeking larger doses of THC. However, in many provinces and territories, there are legal edible products containing 10 milligrams of THC that are available for as little as $3.

Industry also noted U.S. state markets, where edible cannabis comprises a greater share of the legal cannabis market, as well as estimates of illicit spending on edible cannabis products in Canada that suggest millions of dollars in revenue may currently be captured by the illicit market. Industry representatives also shared anecdotes about customers seeking larger amounts of THC, and some submissions we received referred to consumer research that suggests some cannabis consumers are critical of the current limit.

Public health researchers pointed to recent survey findings that suggest that only 12% of respondents, and 18% of cannabis consumers, were opposed to the THC limit on edible cannabis. Footnote 49 As well, public health stakeholders highlighted research (described in Chapter 10 of our What We Heard Report ) that found more than two-thirds of people who consume edible cannabis products reported sourcing them legally (in 2021, 68% reported buying exclusively from the legal market, 15% reported buying exclusively from the illicit market and 17% reported mixed sourcing). Footnote 50 Based on this evidence, they suggested that for most edible cannabis consumers, the current limit is sufficient and is not an impediment to legal sourcing. However, it is also apparent that there is a minority of edible cannabis consumers who wish to purchase edible products with more THC in them.

We deliberated extensively on the issue of the THC limit for edible cannabis products. The critical gaps in the current evidence made our efforts to reach a consensus position very difficult. There was a shared view that protection of children from accidental consumption is the paramount concern. Edibles come in forms that are much more attractive to children than dried cannabis and other cannabis products, therefore, the risk of ingestion is greater. This is reflected in the more stringent approach Health Canada took to regulating edible cannabis when these products were permitted in 2019, as compared to the higher amounts of THC permitted in other products.

We also agreed that any increase in the THC content of edible cannabis products would need to be coupled with additional controls to reduce the risk of accidental consumption (or over-consumption by adult consumers). Any additional controls would likely add to manufacturing costs for licence holders. Ultimately, we felt that there are too many unknowns and too much uncertainty about the likely consequences of increasing the amount of THC in these products. Therefore, we are of the view that prudence is warranted here and accordingly, we recommend that the current limit be maintained, and that research be undertaken that will fill critical knowledge gaps related to this issue. We also note that consumers wishing to ingest higher doses of THC continue to have access to oral oils and capsules, as well as a range of other cannabis products that do not resemble foods and do not pose the same risk of accidental consumption for children.

We encourage Health Canada to incorporate emerging evidence into future decisions related to the regulation of edible cannabis (which may suggest that THC limits could be increased or that additional controls are needed). This research needs to help characterize the likely impacts of a potential change at the individual and population levels, and on adult consumers, as well as those at risk of being unintentionally exposed, especially children.

Maintaining home cultivation rules

While home cultivation was a controversial topic at the time of legalization, it was not raised as a priority during our engagement. Most stakeholders who spoke to the issue of home cultivation supported the current approach (that is, the ability of adults to grow up to 4 plants in their residence). Some called for additional information to be made available on the health and safety risks associated with growing cannabis in or around a person's home (for example, detrimental effects on indoor air quality, electrical hazards, increased risk of fires).

There was no evidence that suggested reforms are needed to the federal rules on home cultivation. We do encourage continued efforts to raise awareness and provide information about potential risks, including safe storage of cannabis products in the home.

The federal framework for cannabis includes various measures aimed at protecting public safety and discouraging activities conducted outside the legal regime. Footnote 51 Central to the approach to displace the illicit cannabis market is providing adult consumers with the ability to purchase cannabis from legal, regulated sources, while setting out offences and sanctions to deter criminal activity and supporting law enforcement action against those who engage in illicit activities. Footnote 52

We note considerable progress has been made in achieving some of the important objectives of the legislation. It is clear that consumers who wish to access legal, regulated products can do so, and we are encouraged by evidence regarding the displacement of the illicit market.

As described in our What We Heard Report , there was a 95% reduction in the number of charges for cannabis possession between 2017 and 2022. We are encouraged that the provision of legal access to cannabis has reduced the negative impacts of prohibition which resulted from interactions with the criminal justice system. Footnote 53

We are concerned, however, with the criminal activity that persists. Of particular concern are the activities of organized crime and criminal networks (which often involve trafficking other substances and firearms, the use of firearms and the use of proceeds from cannabis to fund other serious criminal activities), the diversion of cannabis by some of those who are registered with Health Canada to produce cannabis for medical purposes as a source of illicit supply, the proliferation of unauthorized retail stores on First Nations reserves (that is, stores operating without community approval, or a provincial or territorial authorization) and the relative ease with which unauthorized online sellers operate.

We are also struck by the limited enforcement action against these criminal activities. We were provided with some examples of large-scale investigations leading to charges and convictions, especially for the import and export of cannabis. But overall, enforcement of the regime does not appear to be a priority. We appreciate that law enforcement does not have unlimited resources to address criminal activity and must prioritize its efforts; however, the integrity of the cannabis regime depends on deterring criminal activity. The absence of consequences, or any fear of consequences, will lead criminal actors to continue their activities, resulting in harm to individuals and communities. We also heard that the lack of law enforcement action leads some consumers to believe that illicit cannabis does not pose health or safety risks, or that the illicit cannabis is in fact legal. In this chapter, we offer recommendations to improve consumers' ability to distinguish between legal and illicit cannabis, as well as a series of observations that relate to the leading cannabis-related enforcement issues.

Addressing the illicit market

The evidence available to us indicates that there has been substantial displacement of the illicit market. While there are different approaches to assessing the extent of displacement, and some debate over individual estimates, it is clear that meaningful progress has been made over the first 5 years of legalization at the national level. For example, the latest estimate from Statistics Canada suggests that in the third quarter of 2023, 73% of household expenditures on non-medical cannabis was from legal sources, while the latest findings from the Canadian Cannabis Survey suggest 79% of cannabis consumers reported always or mostly obtaining cannabis from legal sources. Footnote 54 , Footnote 55

However, these reports and surveys about displacement rely on self-reported data, and some participants in our review cautioned that they do not tell the full story, which may lead to an underestimation of the size of the illicit market. Some survey respondents may not be truthful about the source of their purchases, for example, or may believe that they have purchased cannabis legally, given the efforts some illicit sellers take to make their products and presence look legitimate.

Some stakeholders have questioned recently published findings from the 2023 Canadian Cannabis Survey that indicated only 3% of cannabis consumers reported usually obtaining cannabis from illicit sources (that is, an illegal store, illegal website or dealer), although notably an additional 15% of consumers reported usually obtaining cannabis from social sources (that is, acquaintances, friends or family members). In response to a separate question, 15% of consumers indicated that they rarely or never buy from legal sources. Footnote 55

Continued monitoring of the legal share of the total market, along with regular public reporting on the extent to which the illicit market has been displaced, will be important to help guide policymaking and priority-setting by all levels of government. We caution against relying on a single measure of displacement and advise examining multiple indicators together when trying to gauge progress. This effort should include disaggregating by type of cannabis product (for example, examining dried cannabis and cannabis vaping products separately), assessing differences in the extent of legal sourcing in different regions and considering different types of consumers. National estimates, and those that rely on one type of indicator, lack nuance and obscure important trends. For example, we heard from some First Nations communities who have seen organized crime groups move into their territories and increase the illicit trade of cannabis locally. Such activities are not detectable in national, provincial or territorial spending figures.

We also caution against setting a displacement target. We believe that a target would be arbitrary and may lead to unintended consequences (for example, after the target is reached, criminal enforcement activities may be deprioritized and resources redirected, which could be exploited by illicit operators and organized crime). Rather, the Government of Canada should strive to displace the illicit market to the extent possible and implement measures that promote a continued transition toward a legal, regulated cannabis market.

The Government of Canada should support continued displacement of the illicit market, relying on strategies that prioritize the protection of public health and public safety. To support further displacement, the government should employ measures that both "push" and "pull" consumers to the legal market and consider initiatives that address both supply and demand. Examples include permitting product types and formats that are reasonably competitive with those on the illicit market (while maintaining safeguards to mitigate risks to public health and public safety), disseminating information for consumers in an effort to discourage demand for illicit cannabis products and taking enforcement actions against illicit producers and sellers to reduce the supply of illicit cannabis.

Organized crime and criminal networks

Law enforcement highlighted the ongoing involvement of organized crime in the production and supply of illicit cannabis. They noted investigations have established linkages between organized crime suppliers and online sellers. Illicit supply may end up being distributed and sold in different places (for example, the export market). We heard concerns about the illicit market supplying products to unauthorized stores on First Nations reserves (that is, stores operating without approval from the community, or a provincial or territorial authorization) and to unauthorized retail stores that are re-emerging in major cities and to illicit online sellers.

Diversion of cannabis from personal and designated production for medical purpose sites

As discussed in Chapter 11, some law enforcement officials pointed to the abuse of the personal and designated production of cannabis for medical purposes program as a contributor to illicit supply. Some criminal actors seek registrations for large plant counts without having any medical need and solely as a means to provide cover for their illicit production activities. We also heard concerns about the resulting threat to public safety for residents near areas where this large-scale, organized criminal activity takes place.

Health Canada must do more to address the practices that lead to registrations that produce large amounts of cannabis for the illicit market. This needs to involve action on a number of fronts, including restricting the number of registrations on a single site, seeking additional justifications from authorizing health care professionals about the amounts of cannabis they are recommending and refusing or revoking applications where there are risks to public health or public safety (including the risk of cannabis being diverted). See Chapter 11 for a broader discussion and recommendations related to the personal and designated production program.

Unauthorized retail stores on First Nations reserves

As discussed in Chapter 7, illicit cannabis operations on First Nations reserves that are not authorized by the community pose many health and safety problems for residents. These stores sell unregulated products that do not comply with product, packaging or labelling rules, including products designed to be attractive to youth. Community leaders believe that many of these stores are supported by criminal elements from outside of their communities. We heard that community leadership and police services often do not have the capacity to shut down these stores, and there needs to be more assistance from, and coordination with, other police services that are responsible, such as the Royal Canadian Mounted Police or provincial police services.

Illicit online sales

We heard about illicit sales of cannabis on both the dark web and the surface or traditional web, including how illicit sellers use websites and social media to facilitate their sales. These sites and platforms offer anonymity and ease of access (including for youth) and offer products that are not available in the legal market (for example, edible products with higher amounts of delta-9-tetrahydrocannabinol [THC], or products that are designed to be attractive to youth).

Sites on the surface web often appear to be legal, offering a variety of payment methods (including Interac and credit card), which may cause consumers to believe they are legitimate. Law enforcement indicated that investigating illicit online sellers is a significant challenge due to the complexity and time involved in locating, identifying and tracking the host of the websites. Illicit operators often use virtual private networks or route their address through multiple jurisdictions to camouflage their locations. Further, even if an illicit site has been identified and shut down, it is relatively simple for the criminal actors to launch another site.

Addressing illicit market actors

Enforcement action to address the criminal activity of illicit market actors is essential to achieving the Cannabis Act 's (the Act) public safety objectives.

Law enforcement has a vital role to play in enforcing the criminal offences in the Act. Notwithstanding the other priorities they must manage, we encourage law enforcement to increase their focus on cannabis-related criminal activity, especially when organized crime is involved. Since the burden of enforcement should not fall entirely on the police, we encourage Health Canada, Public Safety Canada and regulators in the provinces and territories to work with law enforcement to develop a comprehensive strategy to address illicit activity.

However, we also recognize there is an opportunity for other (non-criminal enforcement) activities to address both demand and supply, to deter criminal activity and support further displacement to the legal market.

On the demand side, we emphasize the need to collect better information about the motivation of consumers for buying from illicit sources, as this will shape the direction of policy in the future. In the interim, continued dissemination of practical information for occasional consumers about how to recognize legally produced cannabis and authorized retailers may better equip them to recognize and choose legal products (for example, looking for excise stamps, child-resistant packaging or the standardized cannabis symbol). We understand that both Health Canada and some provincial and territorial distributors have done this. For legacy consumers, price declines in the legal market may also influence their choice of markets, especially for product formats other than dried cannabis where price differences remain. However, as noted in Chapter 8, we would not want to see lower prices encourage consumption.

While Health Canada's primary role is to licence and oversee the legal industry, we understand it works closely with law enforcement and may refer suspected illicit activity for investigation (for example, complaints received about illicit sellers or information about unauthorized production for medical purposes). We encourage the department to continue this and to work with law enforcement and provincial and territorial partners to issue public advisories or other forms of communication about illicit products and the harm they pose. This could involve regularly testing seized products and releasing information about the presence of contaminants and THC quantities or concentrations.

On the supply side, we see potential for the use and enforcement of municipal zoning bylaws, or business licensing rules, to discourage the proliferation of illicit physical stores. We note provisions in British Columbia legislation, for example, which enable charges to be laid against the landlords of illicit physical stores. In our view, landlords should not profit from leasing to businesses selling illicit cannabis, nor should illicit sellers be able to use these stores and the signage associated with them to encourage consumption and entice youth.

We recognize that police investigations into illicit online sellers are time consuming and require specialized competencies and tools which may not always be available, especially for smaller police services. We encourage governments to consider the approach of British Columbia's Community Safety Unit, where civilian investigators coordinate enforcement actions with law enforcement partners locally and across Canada. We understand that this Unit has access to tools to investigate potential illicit operators (sellers and producers). It is authorized to demand and inspect records, seize and destroy illicit cannabis products and other items, and impose monetary penalties against illicit operators.

British Columbia has had some success in disrupting the activities of illicit online sellers. Over 1,500 sites were investigated as of January 2024, with almost 1,000 disrupted. Nonetheless, we heard that there are limitations due to the lack of legal authority compelling Internet service providers to remove illicit content. Footnote 56 Similarly, there is no requirement for financial institutions to track and prevent illicit actors from using their services. We understand some provinces are considering measures in this area, by amending laws to provide authority for judicial orders, to compel the removal of illegal sites from online platforms and to compel financial service operators to provide financial information that helps identify illegal online cannabis operators and to stop providing services to those operators. We feel it would be in the best interests of public health and public safety for various levels of government to consider new tools aimed at shrinking the amount of harmful criminal activity online.

In this regard, we note that the Government of Canada recently introduced Bill C-63, the Online Harms Act . The purpose of this proposed legislation is to, among other things, promote online safety and to reduce harms caused as a result of harmful content (such as hate speech, or content that insights violence). It would create a Digital Safety Commission to administer and enforce the Act, including requirements for the operators of social media services to implement measures to mitigate the risk that users will be exposed to harmful content on their services, and to integrate features to protect children. We encourage parliamentarians to consider how the proposed legislation could be used to better protect children and youth from the harms associated with exposure to substances, including cannabis.

Cannabis-impaired driving

We heard that cannabis-impaired driving continues to be a significant concern that requires ongoing enforcement efforts. Law enforcement officials, especially those in rural and remote communities, told us that they face challenges accessing the tools, training and personnel required to detect cannabis use and confirm impairment in drivers. Cannabis-impaired driving is an area that deserves priority attention because the actions of impaired drivers can result in serious injury or loss of life to the drivers and others.

We appreciate that governments at all levels, as well as civil society actors, have made efforts to emphasize the importance of not driving while impaired by cannabis. Given the significant shifts in social norms with respect to driving while impaired by alcohol, there are likely lessons that can be applied to prevent cannabis use and driving.

Access to cannabis for medical purposes was one of the more complex issues we were asked to review. We recognize that there are longstanding court-affirmed rights to reasonable access to cannabis for medical purposes. However, legalization changed the context for this form of access; there is no longer an absolute prohibition on cannabis, as was the case when the medical regime was developed in the early 2000s. This initial regime provided a way for people to legally possess and produce cannabis, and later to legally purchase cannabis, for their own medical use without the fear of being investigated, charged and possibly jailed.

The medical regime now exists within a broader legal framework where all adult Canadians can legally purchase and possess cannabis, and in most provinces and territories, also legally grow up to 4 plants. Footnote 57 Patients who wish to use the medical access program, including young persons, must have a medical document from a health care professional, which includes an authorized daily amount based on medical need (set out in grams of dried cannabis per day); however, there is no limit to how much cannabis a health care professional can authorize. Footnote 58 In the medical access program under the Cannabis Regulations , individuals have the option to register with a seller licensed by Health Canada to purchase cannabis products that are then shipped to them or to register with Health Canada to grow cannabis or designate someone to grow it on their behalf (this is referred to as personal or designated production).

In 2016, the Task Force acknowledged that a separate system would be necessary to preserve medical access for patients at a time of unprecedented change. It recognized that the medical access system would need to be reviewed in light of legalization and recommended that the Government of Canada evaluate the framework within 5 years of legalization.

The Task Force also acknowledged that while a regulatory pathway existed for the approval of cannabis medicines (that is, pharmaceutical drugs with a Drug Identification Number), uptake was limited. It noted that the Government of Canada needed to do more work to promote and support pre-clinical and clinical research to facilitate the approval of cannabis-based medicines held to pharmaceutical standards, recognizing that research and drug development processes take many years. It also noted the federal government's efforts to explore a different pathway for "wellness" products (for example, products containing cannabidiol [CBD] or non-psychoactive cannabinoids), such as those modelled on natural health products. Notwithstanding the Task Force's recommendations, limited progress has been made to improve medical access through either the pharmaceutical drug (drugs with a Drug Identification Number) or health product streams.

Throughout our review, we heard a range of perspectives on the future direction of access to cannabis for medical purposes, as well as an underlying sentiment of frustration with the current state of access. The legalization of cannabis has had a profound impact on how Canadians access cannabis. However, patients, health care professionals, medical regulatory bodies, municipalities and law enforcement have all voiced concerns about how legalization has impacted access to cannabis for medical purposes. Further, legalization has not resulted in the desired improvement to the clinical knowledge about cannabis for medical purposes, and there continues to be stigma around its use.

We heard from many patients and their caregivers, as well as patient advocacy groups, harm reduction groups, cannabis clinics and compassion clubs, and recognize the desire of many people to have access to cannabis for medical purposes to manage their symptoms and conditions. Given the lack of progress towards the approval of cannabis as pharmaceutical drugs and of health products containing cannabis, we see a need to maintain a distinct medical access program, with improvements, to better support patient care and to address abuse of the personal and designated production program. Currently, the medical access program is the only system that offers patients using cannabis for medical purposes oversight from a health care professional.

Despite limited clinical evidence regarding the therapeutic benefits of cannabis, individuals suffering from a variety of medical conditions report deriving therapeutic benefits from cannabis. Many Canadians use the medical access program, and many more report using cannabis for medical purposes outside the medical access program.

As of September 2023, there were approximately 203,000 individuals registered to obtain cannabis for medical purposes. This includes the 188,000 Canadians registered with licensed sellers and the 15,000 Canadians registered with Health Canada for personal and designated production. Registrations for personal and designated production are almost all for personal production, with only 300 registrations for designated production. In contrast, at the time of legalization, some 371,000 Canadians were registered to access cannabis for medical purposes: 345,000 with licensed sellers and 26,000 with Health Canada for personal and designated production (of which 1,300 were for designated production). Footnote 59

Those involved with the medical program shared numerous suggestions for improvements, including supporting greater recognition of cannabis as a harm reduction tool, greater access to knowledgeable health care professionals, more reliable and affordable product options, and improved eligibility for insurance coverage.

We appreciate that there are still significant gaps in the evidence in this area and recognize that cannabis is not a suitable treatment for many individuals, nor is it risk-free. At the same time, there is a need to continue to support the 203,000 currently registered patients who rely on the medical access system, as well as enhancing the program for future registrants. This chapter details ways to better support patients within the parameters of the program and the evidence that exists today. As our proposed changes are implemented, we hope that there would be an assessment of their impact, as well as any additional evidence developed. This would help guide future decisions related to medical access.

Enabling pharmacy access

In our view, an important change to improve access to cannabis for medical purposes would be to allow patients to obtain cannabis in-person from pharmacies. Some jurisdictions that permit medical access (such as Australia, France, Germany, Israel, Italy and the United Kingdom) use pharmacies as the means to distribute cannabis through prescriptions. While the individual regimes vary (some make very limited product forms available and some offer insurance coverage), the pharmacy distribution model recognizes there are benefits to cannabis being provided in a manner similar to pharmaceutical medications.

Pharmacies are equipped to manage many types of products. We believe pharmacy systems and infrastructure can be adapted to handle cannabis, given they already manage controlled substances, such as narcotics. Enabling this form of access would address patient concerns about the delays with mail delivery and product shortages they encounter today. It would also provide patients with an opportunity to consult with pharmacists and be counselled on effects on mental health (such as psychosis) and issues of medication management (for example, getting advice about contraindications and interactions with other substances).

We understand that the Cannabis Regulations already enable distribution of cannabis by hospital pharmacists so that patients can continue to have access to cannabis while seeking treatment at a hospital. While this is not a major element of the current regime, we believe the current regulations and recent experience could help inform a system that enables wider pharmacy access.

While we believe there would be overall benefit to enabling pharmacy access to cannabis for medical purposes, we understand that some pharmacists and pharmacy regulatory authorities are concerned about the potential for unintended consequences. They have shared concerns that some people may believe cannabis is a prescription medication that meets rigorous safety, quality and efficacy standards because of the involvement of pharmacists in providing it. This issue could be addressed in part by providing better information for health care professionals and for patients.

Establishing a pharmacy access channel cannot happen overnight. It would require regulatory changes from Health Canada, consultation with interested provinces and territories, and regulatory authorities for pharmacists, as well as potential changes at the provincial and territorial level related to the scope of practice of pharmacists. Enhanced cannabis-specific training and education supports would be required to prepare pharmacists for this new role. We note there is already some cannabis-related training available for pharmacists, notably those in Ontario.

Further, we acknowledge that pharmacy access would not address issues of affordability (including the sales and excise taxes that are applied to cannabis products sold for medical purposes). Finally, it is unlikely that every pharmacy would choose to participate in providing cannabis for medical purposes, or that individual pharmacies would stock hundreds or thousands of different cannabis products.

Notwithstanding these issues, we believe Health Canada should take the first steps to create this access channel. This should include establishing requirements for pharmacies to manage the safe storage and handling of the products.

Consultation with relevant parties would be required to ensure the effective development and implementation of access to cannabis for medical purposes in pharmacies. Health Canada should work closely with interested provinces and territories to establish pharmacy access, and to evaluate these efforts for the benefit of other jurisdictions that may be considering similar models.

We also believe that the current mail order delivery system should be maintained for the benefit of patients who prefer that form of access. The mail order access system would also continue to play an important role for patients in areas without pharmacies, or in provinces and territories where pharmacy involvement might be more limited. We understand that the current system also authorizes health care professionals, such as nurse practitioners, to receive cannabis from licensed sellers and to distribute it to patients; these provisions could be expanded to enable the shipment of cannabis from pharmacies to health care professionals, thereby supporting patients in rural or remote regions (for example, those receiving care at nursing stations in the North).

Research on the use of cannabis for medical purposes

Despite recommendations made more than 7 years ago by the Task Force to promote and support pre-clinical and clinical research into the use of cannabis for medical purposes, little progress has been made.

We believe more needs to be done to study the therapeutic uses of cannabis to better understand both the potential benefits and the potential risks. We feel that beliefs held by many Canadians on the use of cannabis for medical purposes, or as a substitute for the use of other substances, are not generalizable across health conditions, or specific cannabis products. Further, these beliefs are not based on reliable, high-quality evidence for specific health conditions. Additional research is needed to better guide the use of cannabis for medical purposes.

That said, we feel that cannabis products should follow the same regulatory pathways as other health products in order to obtain a Drug Identification Number and make health claims. Health Canada has established robust systems for evaluating the safety, quality and efficacy of a range of health products, and the evidentiary standards set in these systems should be maintained for cannabis. In our view, advancing research on the use of cannabis for medical purposes hinges on identifying and removing the barriers that currently impede good quality research, and not relaxing standards in the case of cannabis.

Addressing barriers to research

A key barrier that researchers identified to us was difficulty accessing cannabis products manufactured according to Good Manufacturing Practices, which refers to a system of processes, procedures and documentation that ensure a product (for example, a pharmaceutical drug) meets appropriate quality standards for its intended use. Canadians who use cannabis for medical purposes consume a wide array of product types, and the research materials used in clinical studies should reflect this variety. However, some Canadian cannabis licence holders manufacture cannabis products compliant with Good Manufacturing Practices predominantly for export markets (that is, to countries that require this standard for cannabis products, including Australia, Israel and Germany). It may be possible to increase Canadian researchers' access to quality cannabis that meets the requirements under the Good Manufacturing Practices to conduct clinical trials.

Obtaining access to cannabis that meets the requirements under Good Manufacturing Practices is a necessary step to conducting clinical trials with cannabis, but funding is another significant barrier. Given the widespread availability of cannabis and existing beliefs about the medical benefits of products already available, many pharmaceutical companies may not see sufficient return on investment in research and product development, although some companies and academic researchers continue to conduct clinical research with cannabis. Therefore, public investment may be required to make meaningful advances in research on the therapeutic uses of cannabis.

The Government of Canada has an opportunity to encourage researchers to undertake studies on the medical use of cannabis by making research priorities clear and providing targeted funding opportunities. Cannabis, in many different forms, is currently used to treat a range of symptoms and conditions, and prioritization of research needs is important. To that end, we encourage Health Canada to support a transparent process to identify the specific potential therapeutic applications of cannabis that would benefit most from additional study.

Facilitating better information, guidance and education for health care professionals

Throughout our review, we heard that the lack of clinical information, guidance and training for health care professionals on the use of cannabis for medical purposes has a negative impact on patient care. Health care professionals find the medical authorization process (that is, the document required by the regulations that forms the basis of a patient's registration for medical access) difficult to navigate. Many health care professionals are also uncomfortable with the lack of clinical evidence that is available for many uses of cannabis.

In addition, many patients report difficulty finding a health care professional with sufficient knowledge and interest in overseeing cannabis-based therapies. In the absence of knowledgeable health care professionals, some patients obtain their authorizations through cannabis clinics with whom they have little to no prior relationship or history.

We endeavored to consult broadly with the medical community throughout our review but were largely unsuccessful. While we did receive some written submissions, and some physicians attended our roundtables on cannabis for medical purposes, the limited engagement meant that our deliberations on this important issue did not have the benefit of the full perspective of all parts of the medical community.

It is our understanding that many medical professionals are reluctant to recommend that their patients use products that have not gone through a rigorous review process to evaluate their safety, quality and efficacy. However, the reality is that approximately 203,000 Canadians are registered in the medical access program, while many others are using cannabis they obtain from recreational stores or from the illicit market to treat a variety of medical conditions. Most of these people are receiving advice from friends and family members, sales personnel in retail stores ("budtenders") and the Internet. The paucity of health care professionals with knowledge of cannabis therefore leads to a situation where many of these medical consumers are putting themselves at risk.

There should be more education for health care professionals. Some health care professions, including nursing and pharmacy, have taken steps to educate their members. The Canadian Nurses Association, with funding from Health Canada's Substance Use and Addictions Program, developed a national cannabis framework called Non-Medical Cannabis: A Nursing Framework and a nursing e-learning course, Understanding Cannabis in Clinical Practice . The Ontario College of Pharmacists requires practicing pharmacists who provide patient care to complete mandatory cannabis education. We also understand that some medical schools include course modules and information on cannabis, including the Cannabis Education for Health Care Providers Toolkit from the University of British Columbia. However, much more needs to be done to improve the knowledge of health care professionals, especially physicians.

There is an opportunity to improve how knowledge about the use of cannabis for medical purposes is collected and shared. In 2018, Health Canada published Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids which described the evidence available at that time about various conditions and diseases. We encourage Health Canada to update this document and take steps to keep the information up-to-date, such as creating a knowledge hub that can provide health care professionals, researchers and interested members of the public (including patients) with current, reliable information to guide decision-making.

There is also a need to develop and disseminate national clinical guidance documents to increase the knowledge and understanding of health care professionals related to cannabis for medical purposes. These documents should be informed by experts, available scientific research and build on information already available from other jurisdictions. For example, Israel's national cannabis authority has developed clinical guidance for cannabis for medical purposes that covers topics such as: approved clinical indications, products, quantity or concentration, dosing, and abuse and addiction. This material, which was developed with medical associations, gives health care professionals information on which to base their decisions as clinicians.

Advancing cannabis-based health products

In 2019, Health Canada created an independent Science Advisory Committee on Health Products Containing Cannabis to examine the evidence on the use of cannabinoids to treat short-term minor ailments without health care practitioner oversight. In February 2022, the committee published its Review of cannabidiol: Report of the Science Advisory Committee on Health Products Containing Cannabis .

We understand Health Canada is building on this work and exploring the potential for cannabidiol (CBD) to be used as a medicinal ingredient in certain non-prescription health products authorized under the Food and Drugs Act (for example, products suitable to be used for symptomatic relief of stress or promotion of sleep). Other cannabinoids, including delta-9-tetrahydrocannabinol (THC), are not being considered for non-prescription use at this time.

Increased availability of cannabis-based health products that have been reviewed and authorized under the existing framework for non-prescription or natural health products would mark an important advancement, because it would provide Canadians with access to legal products that have been reviewed for safety, quality and efficacy.

Health Canada should also establish a scientific advisory committee to review the science on THC and assess the current evidence (including risks and benefits) on the use of THC for medical purposes. This work should be accompanied by targeted research related to THC and its combination with other cannabinoids, in partnership with agencies such as the Canadian Institutes of Health Research. This would help to move beyond the current situation where cannabis for medical purposes is not subject to standard drug approval processes and is viewed by many in the health sector as being outside of evidence-based or conventional practice.

Amending the medical document

There are other issues within the medical access program that we believe should be addressed, with the medical document being a high priority. To support better understanding among patients, the medical document should include specific information from health care professionals related to product format and dose, similar to other substances.

The current requirement that the authorization is provided only in number of grams of dried cannabis per day that can be consumed by the patient is not adequate. It does not provide any guidance on what product format to use (for example, cannabis oil capsule compared to an oral spray), the cannabinoid profile of the product (for example, THC dominant, CBD dominant) or how many times a day the patient should use cannabis. It leaves patients to interpret too much on their own and may encourage patients to use combustible products rather than non-combustible products (such as edibles or topicals). We recognize that permitting greater specificity in the medical document may present challenges for some health care professionals, and not all may opt to be that specific. However, for those that do choose to provide more specificity, knowledge gaps could be addressed by clinical guidance built from existing information on the use of cannabis for medical purposes.

Addressing abuse of the personal and designated production program

The personal and designated production program provides individuals the option to register with Health Canada to grow cannabis or designate someone to grow it on their behalf. The authorization amount on a person's medical document determines how many plants they can grow. In accordance with a formula in the Cannabis Regulations , this generally translates to 5 plants per gram for indoor growing and 2 plants per gram for outdoor growing.

There is currently no limit to how many plants a registered person can grow, as long as it aligns with the authorization amount set out on their medical document. Additionally, the regulations permit up to 4 individuals to grow cannabis for medical purposes at a single site, which has resulted in locations with thousands of plants.

Some patients who rely on personal or designated production to access cannabis for medical purposes consider it to be a more affordable option than purchasing cannabis from licensed sellers. However, for those who choose to grow cannabis for medical purposes, there are cost implications (such as purchasing starting materials, electricity). Others told us that they rely on personal or designated production because it provides them with reliable access to particular strains of cannabis and avoids situations where licensed sellers stop producing the products they want or stop selling entirely.

We believe that patients should continue to have this form of access available to them; however, it is also clear that additional measures are necessary to prevent abuse of the program and reduce its contribution to illicit supply. Law enforcement, municipalities and patients have all raised concerns about abuse of the personal and designated production program, particularly when individuals have authorizations for large plant counts. They indicated that this abuse is a significant contributor to the supply of illicit cannabis in Canada. We note that law enforcement shared this same concern with the Task Force in 2016. We also heard from municipalities about risks to community safety from such criminal activity taking place in residential areas.

The extent of the abuse of the program is unclear as the evidence is not comprehensive. There have been some large-scale police efforts against these activities, with some leading to charges and convictions. However, as noted in Chapter 11 of our What We Heard Report , the number of charges and convictions related to illicit distribution and sale activities has declined every year since legalization.

While the total number of active registrations for personal and designated production has declined in recent years, there are still thousands of locations where cannabis is being grown under this program. Further, the ability for multiple individuals to locate their production at a single site leads to situations that are comparable to commercial cultivation operations, yet without any of the safeguards applied to commercial licence holders (for example, security requirements and odour control measures). We understand that these types of sites pose particular challenges for law enforcement because of the size of the activities and difficulties in assessing whether individual registrants are complying with the law. We believe that Health Canada should restrict the number of registrations at a single location from 4 to 1, building on information from law enforcement partners about the risks posed by co-location and the extent of illicit activity occurring at these sites.

In addition to risks associated with co-location, the ability to obtain authorizations to grow large quantities of cannabis creates an avenue for patients to use quantities of cannabis that are well over clinical guidance and may be harmful to their health. These health harms may include short-term adverse effects such as cannabis poisoning, or long-term effects such as addiction or impacts on mental health. Additionally, cannabis grown under personal or designated production registrations is not subject to quality controls or mandatory testing. Registered persons could consider making use of licensed analytical third-party testing facilities to ensure the quality and safety of their cannabis.

As of September 2023, the average amount of cannabis authorized for daily use by those buying from licensed medical sellers was 2.3 grams per day. This amount has remained relatively constant since October 2018. In comparison, the average daily amount authorized for those registered for personal or designated production was 33 grams per day as of September 2023, a 28% decrease from the peak of 45 grams per day in September 2021. We note that the average daily amount in British Columbia is well above this, at 59 grams per day. Footnote 59

Health Canada has made progress in addressing high authorization applications (that is, where a health care professional has authorized an amount that would lead to a large number of plants being grown) by seeking additional justification from the health care professional for the amount in question. In the absence of additional evidence or information to support the amount, the department can refuse or revoke the application on the grounds it poses a risk to public health or public safety. However, while Health Canada has held these authorities since 2018 when the Cannabis Regulations came into force, it only began to seek additional justifications in 2021.

Health Canada officials indicated that as of November 2023, there have been 2,942 refusals and revocations, compared to 431 in September 2021, with the majority having been refused or revoked on the basis of risks to public health or public safety. Footnote 60

Health Canada also provides regular reports to provincial and territorial regulatory authorities on health care professionals authorizing over 25 grams per day. Notably, as of September 2023, there were 226 health care professionals associated with authorizations between 25 and 100 grams per day, concentrated in Ontario (104) and British Columbia (72). Footnote 59 While there may be a legitimate medical need for larger amounts, such exceptional cases should be investigated by the relevant regulatory authorities for physicians and nurse practitioners in these provinces. It is our understanding that some regulatory authorities have followed up on the reports and started investigations into the practices of the physicians and nurse practitioners.

The added scrutiny appears to have reduced both the number of individuals registered for personal and designated production of cannabis, and the average amount authorized by health care professionals. Health Canada should continue this work, and extend this additional scrutiny to more registration applications to deter and reduce abuse.

Health Canada should continue to conduct inspections of sites with registrations for personal or designated production. Inspections are an important oversight tool for the department. We understand that findings from inspections can support revocations of registrations and referral to law enforcement (for example, situations where the registered person is growing more plants than they are authorized for).

In our review, law enforcement representatives suggested the elimination of the personal and designated production program. However, we also heard from patients and health care professionals about those who rely on it and carry out their production activities without risk to public health and public safety. If Health Canada contemplates significant changes or elimination of the program in the future, it should carefully consider the potential impacts on patients and have measures in place to address concerns about affordability. It would also need to consider the interests of patients who reside in provinces where the cultivation of cannabis outside the medical access program is prohibited (such as in Quebec and Manitoba).

Supporting innovative approaches within the current system

The current medical access system does offer some flexibility for innovation, enabling support for harm reduction and vulnerable or marginalized populations, when under health care professional supervision and using regulated products. We hope that in the near future, models such as the High Hopes Foundation will be the subject of more evaluation and research.

The High Hopes Foundation is a non-profit initiative focused on harm reduction programming for substance users in Vancouver's Downtown East Side. In 2022, the Foundation was issued a medical sales licence from Health Canada. High Hopes offers compassionate cannabis pricing and aims to minimize costs to patients. The Foundation is the pickup site for individuals who are authorized to use cannabis for medical purposes but who do not have a fixed address or who experience homelessness. We had the opportunity to visit High Hopes in March 2023 to see their model in action.

Ensuring affordability of cannabis products for medical purposes

The cost of cannabis for medical purposes continues to be a major concern for patients. We heard that in some cases, products in the medical market are more expensive than in the non-medical market. This may encourage patients to buy cannabis from a retail store or an illicit source rather than through the medical access program. In doing so, they may not seek out medical oversight and put themselves at risk of receiving products that may cause harm.

Patients want cannabis for medical purposes to be treated like prescription drugs, which are generally covered by insurance or benefit programs and are exempt from excise and sales taxes. Finance Canada should examine the excise tax as it relates to cannabis for medical purposes, especially if pharmacy access is permitted as recommended.

Most patients who use cannabis for medical purposes do not have insurance coverage. Approximately 3% of respondents who completed the medical portion of the 2023 Canadian Cannabis Survey indicated they had full insurance coverage and 4% said they were partially covered. Footnote 61 We heard from several patients that the lack of coverage created a significant cost burden for them. As discussed earlier in this chapter, cannabis for medical purposes does not meet the same standards as prescription medications that are routinely covered under drug insurance plans and is generally not covered by private insurers.

Some participants in our consultations noted the insurance coverage for cannabis for medical purposes for Canadian veterans provided by Veterans Affairs Canada. We also heard about the lack of coverage for First Nations and Inuit under the Non-Insured Health Benefits program, which is administered by Indigenous Services Canada.

The impact of Veterans Affairs Canada's program on the health and well-being of veterans is unclear, and we also heard about the rapid increase in the costs of this program. In 2021-2022, benefits of over $153 million were paid for cannabis, which is nearly double the amount paid for all prescription drugs combined ($79 million). The department has forecast that costs for cannabis for medical purposes will rise to over $380 million by 2026-2027, compared to prescription drugs costs which are forecasted to rise to $124.5 million. Footnote 62 We understand that Veterans Affairs Canada is looking into cost-effective ways to manage the growth in the program.

The Standing Senate Committee on Indigenous Peoples (the Standing Senate Committee) published a report on the implementation of the Cannabis Act and its effects on Indigenous Peoples, and recommended that Indigenous Services Canada cover cannabis for medical purposes under the Non-Insured Health Benefits program. The Standing Senate Committee gave several examples of potential harm reduction initiatives involving cannabis and how lack of access to cannabis for medical purposes may hamper these initiatives. The Standing Senate Committee also reported that individuals may not have the resources to purchase cannabis for medical purposes, which can detrimentally impact their substance use treatment.

Some members of the Panel were supportive of the Standing Senate Committee's recommendation related to benefit coverage for cannabis for medical purposes through the Non-Insured Health Benefits program. These Panel members recognize that many Indigenous Peoples assert that health benefits are an inherent Aboriginal and Treaty right. Without deciding the scope or validity of this assertion, they recognize the Government of Canada's fiduciary duties to Indigenous Peoples generally, and that the program is a means of better ensuring registered First Nations and recognized Inuit achieve an overall health status that is comparable to other Canadians. Understanding the impacts of historical colonialist policies upon Indigenous Peoples, the resultant losses to traditions, cultures, identities and languages, and the ensuing intergenerational traumas, they recognize that many Indigenous People experience disproportionate levels of negative health outcomes. Efforts to redress these health inequities should employ all available and indicated treatments, including cannabis as deemed appropriate by a health care professional. It is the position of these Panel members that it would be an unjustifiable and inequitable error for the Non-Insured Health Benefits program not to provide coverage. These inequities are magnified when compared with the Government of Canada's current coverage for veterans. Acknowledging the concerns presented in the Veterans Affairs Canada coverage model, these members believe coverage as part of the Non-Insured Health Benefits program could be provided on an exceptional basis, rather than as an open benefit.

Other members of the Panel felt it is premature to recommend benefit coverage for cannabis for medical purposes under this program, or any other Government of Canada insurance program. First, as officials noted to the Standing Senate Committee in 2018, there are gaps in the evidence about the use of cannabis for therapeutic reasons. Second, effort needs to be made to understand why the Veterans Affairs Canada insurance program grew so quickly and what this might mean for other benefit programs that might consider providing coverage of the costs of cannabis for medical purposes. Third, further consideration would need to be given to the projected costs and the impacts on the overall budget for the Non-insured Health Benefits program. Fourth, the federal government provides insurance coverage to other groups, including members of the Canadian Armed Forces and the Royal Canadian Mounted Police; Panel members questioned if it would be feasible to extend coverage under the Non-Insured Health Benefits program without accounting for and considering these other federal programs.

All Panel members agree that there are both equity and state of evidence considerations related to the issue of insurance coverage for cannabis for medical purposes. However, we could not find consensus on the issue of whether the Non-Insured Health Benefits program should provide coverage for cannabis for medical purposes.

All Panel members agree that more information would be helpful in finding a way forward. In this regard, the Panel supports further analysis of the recommendation from the Standing Senate Committee, on a priority basis, with Indigenous representatives being meaningfully involved in this work. The Panel also welcomes Veterans Affairs Canada's effort to review ways to manage the growth in its program. Both of these initiatives would also help inform the larger question of whether and under what conditions there should be insurance coverage for cannabis for medical purposes more broadly.

Improving oversight of licence holder and health care professional financial relationships

We heard concerns about conflicts of interest between health care professionals and cannabis clinics receiving funding from the cannabis industry, including federal licence holders. For this reason, provincial and territorial regulatory authorities should require health care professionals to disclose any financial relationships with licence holders (for example, whether they receive payments from licence holders in exchange for authorizing specific products).

A century of prohibition significantly limited cannabis research. While some initial investment was made and there have been meaningful improvements in the state of knowledge about cannabis, we believe that insufficient attention and resources have been committed to support research, surveillance and monitoring. Footnote 63 Five years after the legalization of cannabis in Canada, many critical knowledge gaps remain, and some gaps may take decades to close. These gaps will only be filled through continued study of Canadians' experience with legal access to cannabis and of the evolution in social norms associated with this dramatic shift in drug policy.

Identification of knowledge gaps

Some of the knowledge gaps that were raised with us, as noted throughout this report, include:

• cannabis-related poisonings among children (including the source of the cannabis)
• the amount of cannabis that constitutes a single serving (that is, a standard dose) to guide consumer decision-making
• the impacts and effects of cannabis and legalization, including high-potency and novel cannabis products, on mental health (such as psychosis) and substance use in diverse populations
• the health risks associated with the use of different types of cannabis products, including the emissions of smoked and vaped cannabis
• the impacts of cannabis use or exposure during different stages of life (including prenatal, perinatal and neonatal exposure; among individuals who are pregnant, breastfeeding or chestfeeding; and among seniors)
• long-term or longitudinal studies examining consequences of cannabis and legalization (including a focus on youth)
• the prevalence of people living with cannabis use disorders, and, for those wishing to seek help, their ability to access different types of interventions, including targeted prevention and treatment programs
• the impact of delivering different types of interventions, including targeted prevention and treatment programs and interventions for frequent consumers and those at risk
• the impact and effects of cannabis and legalization on First Nations, Inuit and Métis, as well as equity-deserving groups and different subpopulations (including disparities in enforcement)
• the impacts of different policy approaches by provinces and territories on cannabis use and harms
• the impacts associated with possible changes to product regulations, including potential modification to the delta-9-tetrahydrocannabinol (THC) limit for edible cannabis products, including the effects on adult consumers, those who might be unintentionally exposed (especially children), and the displacement of the illicit market
• the use of cannabis for medical purposes, including the benefits and harms associated with using cannabis for different conditions

An additional area for research that was not raised extensively in our consultations but we feel is important to note, is the lack of supports and services for individuals with problematic use or who have cannabis use disorder. We anticipate a need for improved services and treatment, but recognize that cannabis is one of many substances that can lead to problematic use, and that data is lacking on the extent of demand for treatment, the use of treatment services and the efficacy of different interventions. To support further improvements in this area, we would encourage further research on best practices for screening, interventions and treatment for problematic cannabis use and cannabis use disorder.

All of these areas are important. However, we recognize that choices need to be made about which research needs should be prioritized for investment. We encourage the federal departments and agencies involved in funding and using the results of research to work with stakeholders, including those with lived and living experience and from marginalized communities, to identify priorities to guide research activities over the next few years. We understand that the Canadian Centre on Substance Use and Addiction will be convening a workshop with experts in 2024 and suggest that this may be a good place to start a discussion on this topic. Of all these areas, we feel there is an urgent need to examine the factors that are contributing to the observed increases in child poisonings.

Bolstering surveillance and monitoring

In addition to supporting research to fill knowledge gaps, it is important that a robust surveillance system be maintained to monitor the impacts of legalization. This includes the ability to access and use different sources of data, including population surveys, health data, findings of research projects, market data and other information sources that can provide insights into cannabis-related behaviours and cannabis-related health effects over time.

In population surveys and other sources, data on differences between sexes, across age groups and between regions was generally available. However, there was a lack of data available to assess the effects of the new cannabis framework on different racial and ethnic groups, gender minorities, sexual minorities and other subpopulations. We note that additional demographic questions have been, or will be added to some of the data collection tools used by Health Canada and Statistics Canada so that these gaps will be filled to provide better information in the future.

Our understanding of the impacts of cannabis on subpopulations and communities will not improve until sufficiently detailed data is made available to inform research and interpretation of findings.

Surveillance and monitoring activities should also be responsive to the variety of potential impacts of cannabis legalization, including monitoring the state of the cannabis market, social equity impacts and environmental consequences of cannabis legalization (see Chapter 8).

Emphasizing the need for regular reviews of the Cannabis Act

Section 151.1 of the Cannabis Act (the Act) only requires the Minister to cause a single review and does not mandate any future reviews of the implementation or administration of this important piece of legislation. However, it will take years to understand the impact of the Act and other elements of the cannabis framework.

Therefore, we believe the Act should be reviewed at regular intervals by independent experts, to ensure the impacts of the framework are assessed over time. We suggest a 5-year interval for these reviews, and that the Government of Canada amend the Act to require such reviews. Moreover, we believe that there should be some continuity from one review to the next. Our review addressed a number of areas where we made recommendations for reform. The starting point for the next independent review should be to assess the degree of progress made in implementing the recommendations of this review. We would expect Health Canada, in collaboration with other federal departments, to keep track of work done to implement our recommendations and to share this work with the experts leading the next independent review.

As noted in the discussion on social equity in Chapter 8, we believe that an examination of the impact on social equity should be given particular attention in future reviews, in light of historical disparities in cannabis criminalization and the ongoing challenges and inequities faced by marginalized communities.

While periodic reviews of the Act would provide important opportunities to assess progress, we also encourage federal, provincial and territorial governments to evaluate, on an ongoing basis, their cannabis frameworks, including laws, regulations, policies, programs and interventions. Regular evaluation and changes are important to ensure the successful implementation of any initiative. In some instances, it may be appropriate for the monitoring and evaluating to be performed by an independent body. Regardless of the nature of the evaluation, reviews should adequately assess the effectiveness of a given program or initiative to determine if its intended objectives are being met. These evaluations should be made public to ensure transparency and accountability.

Summary of engagement

We engaged with stakeholders between December 2022 and January 2024. We used a range of methods to conduct our engagement. These activities occurred with stakeholders throughout Canada, through one-on-one, sectoral and multi-sectoral meetings conducted in-person, via videoconference and in a hybrid format. We also heard from individuals and organizations who took the time to put their views in writing. While significant effort was made to ensure a broad range of voices were incorporated in our engagement activities, we acknowledge that not all perspectives were heard.

We would like to recognize the many individuals and organizations who shared their time and expertise with us. To protect privacy and confidentiality, individual names will not be disclosed, unless otherwise stated.

We met with over 600 individuals from over 250 organizations in nearly 140 meetings.

The names of all the organizations and experts we engaged with are listed below:

• 1286455 BC Ltd
• 420 Cannabis Court
• Adams Lake Indian Band
• Afro BudSistas
• Aitchelitz First Nation
• Alberta Alliance Who Educates and Advocates Responsibly
• Alberta Gaming, Liquor and Cannabis Commission
• Alberta Municipalities
• Alcohol and Gaming Commission of Ontario
• All Nations
• Anishinabek Nation
• Antidote Processing
• Dr. Michael Armstrong, Brock University
• Arthritis Society
• Assembly of First Nations
• Association pour la santé publique du Québec
• Association québécoise de l'industrie du cannabis
• Atlegay Fisheries
• AUBE Patients
• Dr. Lynda Balneaves, University of Manitoba
• Dr. Daniel Bear, Humber College
• Dr. Neil Boyd, Simon Fraser University
• British Columbia Assembly of First Nations
• Dr. Paula Brown, British Columbia Institute of Technology
• Dr. Jason Busse, McMaster University
• C-45 Quality Association
• CAFCAN: Caribbean African Canadian Social Services
• Canada House Wellness Group Inc.
• Canadian Association of Chiefs of Police
• Canadian Association of Elizabeth Fry Societies
• Canadian Centre for Policy Alternatives
• Canadian Chamber of Commerce
• Canadian Health Food Association
• Canadian Hemp Farmers Alliance
• Canadian Hemp Trade Alliance
• Canadian Mental Health Association
• Canadian Paediatric Society
• Canadian Pharmacists Association
• Canadian Police Association
• Canadian Psychological Association
• Canadian Public Health Association
• Canadian Students for Sensible Drug Policy
• Canadian Therapeutic Cannabis Partners Society
• Canadian Vaping Association
• Canadian Women in Cannabis
• Cannabis Council of Canada
• Cannabis Health Products Coalition
• Cannabis NB
• Cannaworld Ventures
• Cannibble Foodtech Ltd.
• Canopy Growth Corporation
• Dr. Alexander Caudarella, Canadian Centre on Substance Use and Addiction
• Centre for Addiction and Mental Health
• Centre on Drug Policy Evaluation
• Chiefs of Ontario
• City of Calgary
• City of Toronto
• City of Yellowknife
• Dr. Hance Clarke, University Health Network
• CommPharm Consulting
• Community Futures Central Kootenay
• Dr. Cecilia Costiniuk, McGill University
• Council of Yukon First Nations
• Covenant House
• Data Communications Management
• Dr. David Décary-Hétu, Université de Montréal
• Diplomat Consulting
• DiversityTalk
• Dr. Jennifer Donnan, Memorial University of Newfoundland and Labrador
• Ekosi Health
• Faded Living 420
• Federation of Sovereign Indigenous Nations
• Dr. Yaron Finkelstein, University of Toronto, The Hospital for Sick Children
• Fire & Flower Holdings Corp.
• First Nations Leadership Council
• Food, Health & Consumer Products of Canada
• Dr. Chelsea Gabel, McMaster University
• Government of Alberta
• Government of British Columbia
• Government of Canada (Canada Border Services Agency)
• Government of Canada (Canada Revenue Agency)
• Government of Canada (Canadian Institutes of Health Research)
• Government of Canada (Department of Justice Canada)
• Government of Canada (Finance Canada)
• Government of Canada (Health Canada)
• Government of Canada (Innovation, Science and Economic Development Canada)
• Government of Canada (Privy Council Office)
• Government of Canada (Public Health Agency of Canada)
• Government of Canada (Public Prosecution Service of Canada)
• Government of Canada (Public Safety Canada)
• Government of Canada (Royal Canadian Mounted Police)
• Government of Canada (Statistics Canada)
• Government of Canada (Veterans Affairs Canada)
• Government of Manitoba
• Government of New Brunswick
• Government of Newfoundland and Labrador
• Government of Northwest Territories
• Government of Nova Scotia
• Government of Nunavut
• Government of Ontario
• Government of Prince Edward Island
• Government of Quebec
• Government of Saskatchewan
• Government of Yukon
• Great Gardener Farms
• Dr. Lorraine Greaves, Centre of Excellence for Women's Health
• Green Wynds Farm Ltd
• Greenleaf Medical Clinic
• GreenPort Global
• Greentone Cannabis
• Gwa'sala-Nakwaxda'xw
• Habitus Consulting Collective
• Haisla Nation
• Dr. David Hammond, University of Waterloo
• High Hopes Foundation
• High Tide Inc.
• Dr. Carol Hopkins, Thunderbird Partnership Foundation
• Amy House, York University
• HRVSTR Cannabis Inc.
• Dr. Elaine Hyshka, University of Alberta, Royal Alexandra Hospital
• Institut national de santé publique du Québec
• Inuit Tapiriit Kanatami
• Inuvialuit Regional Corporation
• Israeli Medical Cannabis Agency
• IWK Health Centre
• John Howard Society of Canada
• John Howard Society of Ontario
• Justice for Children and Youth
• Dr. Didier Jutras-Aswad, Centre hospitalier de l'Université de Montréal
• Kahnawà:ke Policing Functions
• Kahnawà:ke Shakotiia'takehnhas Community Services
• Dr. Lauren Kelly, The Canadian Collaborative for Childhood Cannabinoid Therapeutics
• Khowutzun Development Corporation – Cowichan Tribes
• Dr. Beau Kilmer, RAND Drug Policy Research Center
• Kootenay Aeroponic
• Kwaw-kwaw-Apilt First Nations
• Labstat International
• Lasqueti Cannabis Corp
• Claude Lavoie
• Les Femmes Michif Otipemisiwak
• Liquor, Gaming and Cannabis Authority of Manitoba
• London Drugs Commission
• Los Angeles Department of Cannabis Regulation
• Dr. James MacKillop, McMaster University
• Manitoba Liquor and Lotteries
• Manitoba Métis Federation
• Media Smarts
• Medical Cannabis Canada
• Mental Health Commission of Canada
• Métis Nation – British Columbia
• Métis Nation of Alberta
• Métis Nation of Ontario
• Métis Nation – Saskatchewan
• Métis National Council
• Mohawk Council of Akwesasne
• Mohawk Council of Kahnawà:ke
• Munsee-Delaware Nation
• Mynd Life Sciences
• Nanoose First Nation
• Nathan Richards Legal
• National Association of Pharmacy Regulatory Authorities
• National Indigenous Economic Development Board
• Neskonlith Indian Band
• New Jersey Cannabis Regulatory Commission
• New York Office of Cannabis Management
• Nipissing First Nation
• NORML Canada
• Nunalituqait Ikajuqatigiitut Inuit Association
• Nunatsiavut Government
• Nunavik Health Board
• Nunavik Police Services
• Nunavik Regional Board of Health and Social Services
• Nunavut Tunngavik Incorporated
• Oceanic Releaf
• Okanagan Indian Band
• Okpik Consulting
• Ontario Cannabis Store
• Ontario Provincial Police
• Ontario Public Health
• Origine Nature
• Eugene Oscapella, University of Ottawa
• Ottawa Inner City Health
• Ottawa Public Health
• Dr. Akwasi Owusu-Bempah, University of Toronto
• Dr. Rosalie Pacula, University of Southern California, International Society for the Study of Drug Policy
• Partners for Youth Inc.
• Pauktuutit Inuit Women of Canada
• Penticton Indian Band
• Pine River Institute
• Premo Packaging and Design Co.
• Pure Sunfarms
• Qarjuit Youth Council
• Québec Craft Cannabis
• Dr. Andrew Reid, Douglas College
• Retail Cannabis Council of Ontario
• Retired Ontario Court of Justice
• Rosebud Cannabis Farms
• Royal College of Physicians and Surgeons of Canada
• Samson Cree Nation
• Santé Cannabis
• Saskatchewan Liquor and Gaming Authority
• Secluded Wellness Centre
• Service de police de la Ville de Gatineau
• Shoppers Drug Mart Inc.
• Shxwhà:y Village
• Shxw'ōwhámel First Nation
• Siska Indian Band
• Six Nations Cannabis Commission
• Six Nations of the Grand River
• Six Nations Police
• SOLID Outreach
• Squamish Nation
• Sûreté du Québec
• Sweetgrass Trading
• Tantalus Labs
• The Cannabis Nurses
• The Cronos Group
• Dr. Phil Tibbo, Dalhousie University
• Timixw Holdings
• Tl'azt'en Nation
• TRACE Youth Cannabis Research Program
• Transform Drug Policy Foundation
• Ts'il Kaz Koh First Nation
• Tyendinaga (Mohawks of the Bay of Quinte)
• Tyendinaga Police Service
• Union of British Columbia Indian Chiefs
• Upstream Ottawa
• Valhalla Craft Cannabis
• Victoria Cannabis Buyers Club
• Victoria Cannabis Company
• Village Bloomery
• Ville de Laval
• Washington State Liquor and Cannabis Board
• We Wai Kai Nation
• Weaving Wellness Centre
• Western Arctic Youth Collective
• Wholeland Enterprises
• Wikwemikong
• Williams Lake First Nation
• World Class Extractions
• YMCA Youth Cannabis Awareness Program
• Youth Leadership Team (Tobacco Control and Vaping)

Morris Rosenberg (Chair)

Morris Rosenberg, C.M., is a Canadian lawyer and former senior civil servant with the Government of Canada.

Mr. Rosenberg served as Deputy Minister of Foreign Affairs (2010–2013), Deputy Minister of Health (2004–2010), and Deputy Minister of Justice and Deputy Attorney General of Canada (1998–2004). He began his public service career with the Department of Justice in 1979. From 1989–1993, he served as Assistant Deputy Minister in the Department of Consumer and Corporate Affairs. From 1993–1996, he served as Assistant Secretary to the Cabinet, Economic and Regional Development Policy, Privy Council Office. He was appointed Deputy Secretary to the Cabinet (Operations) in 1996. After retiring from the government in 2013, Mr. Rosenberg served as President and CEO of the Pierre Elliott Trudeau Foundation from 2014–2018.

Mr. Rosenberg holds a B.A. from McGill University, an LL.L. from the  Université de Montréal  and an LL.M. from Harvard University. He was appointed Member of the Order of Canada in 2015.

Dr. Oyedeji Ayonrinde

Dr. Oyedeji Ayonrinde is an Associate Professor in the departments of Psychiatry and Psychology at Queen's University. He is also a Consultant Psychiatrist and Clinical Director at Providence Care, where he has provided community mental health care over the past five years. Prior to these roles, he was a consultant at the Bethlem Royal and Maudsley Hospitals (UK) and lectured at the Institute of Psychiatry for nearly 20 years. He holds a specialist Fellowship in both general Psychiatry and Addictions from the Royal College of Psychiatrists (UK), an MSc (Research in Psychiatry) from University College London, and an Executive MBA from Imperial College, London. Dr. Ayonrinde is a member of the Canadian Psychiatric Association, Fellow of the American Psychiatric Association and Royal College of Psychiatrists. His peer-reviewed publications focus on risks with gestational cannabis use, cannabis and psychosis, and safety issues with cannabinoid-based medicines. Dr. Ayonrinde has received healthcare and university education awards, as well as national and international awards for cannabis-related scholarship.

Dr. Patricia J. Conrod

Dr. Conrod is a registered clinical psychologist, a Full Professor in the Department of Psychiatry and Addiction at the University of Montreal, and researcher at the Sainte-Justine Mother and Child University Hospital Centre (CHUSJ), where she holds a Tier 1 Canada Research Chair in Preventative Mental Health and Addiction and runs a research laboratory focusing on understanding, preventing and treating neurodevelopmental risk factors and consequences of substance use and misuse. She co-leads the Fonds de recherche du Québec (FRQS) Research Network on Suicide, Mood Disorders and Related Conditions, the Canadian Institutes of Health Research (CIHR) Canadian Cannabis and Psychosis Research Team, and the CHUSJ IMAGINE Centre for pediatric neuroimaging. She is also Director of the University of Montreal Neuroscience and Mental Health Strategy. She holds a PhD in Psychology (clinical) from McGill University and has published over 247 articles.

Lynda L. Levesque

Lynda Levesque is a proud nehiyaw iskwew and member of the Fisher River Cree Nation in Manitoba, Treaty Five territory.

Ms. Levesque is a criminal lawyer, with experience practicing from both the prosecution and defence perspectives. Since 2018, she has worked as a Crown Prosecutor in Calgary and surrounding rural areas. From 2014–2018, she worked as a duty counsel lawyer with Legal Aid Alberta, serving Calgary and surrounding rural areas. From 2005–2014, she worked as a duty counsel lawyer with Legal Aid Ontario in Toronto. Throughout her legal career, she has maintained a passion for Indigenous justice issues and an interest in better ensuring access to justice for marginalized persons.

Ms. Levesque holds a B.A. from the University of Calgary and an LL.B. from the University of Windsor.

Dr. Peter Selby

Dr. Selby is the Giblon Professor, Vice Chair of Research, and Advisor to the Head of the Mental Health and Addictions Division in the Department of Family and Community Medicine, University of Toronto. He is cross appointed in the departments of Psychiatry and the School of Public Health. As a Senior Scientist at CAMH, his research focuses on innovative methods to understand and treat addictive behaviours and their comorbidities. To support these research initiatives, Dr. Selby has received grants totaling over 100 million dollars from the Canadian Institutes of Health Research, the National Institutes of Health, the Ministry of Health, as well as others. Dr. Selby has held more than 145 grants as Principal or Co-Principal Investigator. He has more than 150 peer-reviewed publications, including 74 as first or senior author. He is also an expert presenter and educator in addiction and mental health especially in primary care and community settings.

A distinctions-based approach acknowledges that each community has a unique culture, territory, history and relationship with the Government of Canada, as well as unique strengths to build on and challenges to face. A distinctions-based approach means working independently with First Nations Peoples, Inuit, Métis Peoples and Intersectional Peoples in recognition of their unique attributes.

Return to footnote 1 referrer

SGBA Plus is an analytical process that uses an intersectional approach to assess how factors such as sex, gender, age, race, ethnicity, socioeconomic status, disability, sexual orientation, cultural background, migration status and geographic location interact and intersect with each other and broader systems of power.

Return to footnote 2 referrer

The Task Force on Cannabis Legalization and Regulation. (2016). A Framework for the Legalization and Regulation of Cannabis in Canada . Retrieved from https://www.canada.ca/content/dam/hc-sc/healthy-canadians/migration/task-force-marijuana-groupe-etude/framework-cadre/alt/framework-cadre-eng.pdf.

Return to footnote 3 referrer

Indigenous affiliation can include: any person or persons of First Nation, Inuit or Métis descent and any community, corporation or business associated with a First Nation, Inuit and Métis government, organization or community.

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THC refers to delta-9-tetrahydrocannabinol, the cannabinoid mainly responsible for the psychoactive and intoxicating effects of cannabis.

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More information on the legislative and regulatory controls designed to minimize the harms associated with cannabis use can be found in Chapter 5.

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The Cannabis Act defines a young person as an individual who is under 18 years of age and establishes criminal prohibitions for possession of more than 5 grams of dried cannabis (or its equivalent in other classes of cannabis) by a young person. Provinces and territories can establish higher age limits; most jurisdictions have established a minimum legal age of 19, except Alberta (age 18) and Quebec (age 21).

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Varin, M., Champagne, A., Venugopal, J., Li, L., McFaull, S. R., Thompson, W., Toigo, S., Graham, E., & Lowe, A.-M. (2023). Trends in cannabis-related emergency department visits and hospitalizations among children aged 0–11 years in Canada from 2015 to 2021: spotlight on cannabis edibles. BMC Public Health (23, 1). https://doi.org/10.1186/s12889-023-16987-9.

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Health Canada. (2024). Canadian Cannabis Survey 2023: Summary . Retrieved from https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/research-data/canadian-cannabis-survey-2023-summary.html.

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Health Canada monitors the percentage of youth (grade 10-12) who report frequent (daily to weekly) cannabis use in the past 30 days as part of public reporting of departmental results. However, this reporting does not identify or establish targets to reduce youth and young adult cannabis use. See: https://www.canada.ca/en/health-canada/corporate/transparency/corporate-management-reporting/departmental-performance-reports/2022-2023-departmental-results-report.html.

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Fischer, B., Russell, C., Sabioni, P., van den Brink, W., Le Foll, B., Hall, W., Rehm, J., & Room, R. (2017). Lower-Risk Cannabis Use Guidelines: A Comprehensive Update of Evidence and Recommendations. American Journal of Public Health (Vol. 107, Issue 8, pp. e1–e12). https://doi.org/10.2105/ajph.2017.303818.

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Fischer, B., Robinson, T., Bullen, C., Curran, V., Jutras-Aswad, D., Medina-Mora, M. E., Pacula, R. L., Rehm, J., Room, R., Brink, W. van den, & Hall, W. (2022). Lower-Risk Cannabis Use Guidelines (LRCUG) for reducing health harms from non-medical cannabis use: A comprehensive evidence and recommendations update. International Journal of Drug Policy (Vol. 99, p. 103381). https://doi.org/10.1016/j.drugpo.2021.103381.

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More information on efforts to disseminate information can be found in Chapters 5 and 6 of our What We Heard Report . See: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/laws-regulations/cannabis-act-legislative-review/expert-panel/legislative-review-cannabis-act-report.html.

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Brief, personality-targeted, cognitive-behavioral interventions refer to therapeutic approaches that focus on addressing specific aspects of an individual's personality, often in a time-limited and structured manner. These interventions combine principles from cognitive-behavioral therapy with a targeted emphasis on personality traits and patterns.

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THC is an intoxicating cannabinoid, whereas CBD is not intoxicating but does have psychoactive effects. See Appendix A for more information.

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Myran, D. T., Pugliese, M., Roberts, R. L., Solmi, M., Perlman, C. M., Fiedorowicz, J., Tanuseputro, P., & Anderson, K. K. (2023). Association between non-medical cannabis legalization and emergency department visits for cannabis-induced psychosis.  Molecular psychiatry , 1-10. https://doi.org/10.1038/s41380-023-02185-x.

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Myran, D. T., Gaudreault, A., Konikoff, L., Talarico, R., & Pacula, R. L. (2023). Changes in cannabis-attributable hospitalizations following nonmedical cannabis legalization in Canada.  JAMA network open ,  6 (10), e2336113-e2336113. https://doi.org/10.1001/jamanetworkopen.2023.36113.

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Cannabinoids are a group of structurally-related chemical compounds initially identified in the Cannabis sativa plant.

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More information on the provincial, territorial and municipal roles and authorities can be found in Chapter 5.

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More information on the core promotion, packaging and labelling controls can be found in Chapter 5.

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THCA (delta-9-tetrahydrocannabinolic acid) is the non-active cannabinoid precursor to THC found in raw cannabis, which converts to THC when heated.

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In this context, terpenes are naturally occurring aromatic chemical compounds found in cannabis plants. Terpenes contribute to the smell and taste of different strains of cannabis.

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Trauma-informed refers to approaches that recognize the connection between trauma and negative health outcomes and behaviours. These approaches aim to minimize the potential for harm and re-traumatization, and to enhance safety, control and resilience for those involved.

Return to footnote 23 referrer

Health Canada. (2023). Data on commercial cannabis licence applications and licences . Retrieved from https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/research-data/commercial-applications-licences.html.

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Lamers, M. (2023, February 24). Indigenous cannabis entrepreneurs underrepresented in Canada, data suggests. MJBizDaily . Retrieved from https://mjbizdaily.com/indigenous-cannabis-entrepreneurs-underrepresented-in-canada/.

Return to footnote 26 referrer

The child welfare legislation ( An Act respecting First Nations, Inuit and Métis children, youth and families , see https://laws-lois.justice.gc.ca/eng/acts/f-11.73/FullText.html) affirms the rights of First Nations, Inuit and Métis to self-government, which includes jurisdiction in relation to child and family services. The legislation ensures that decisions or actions in respect of providing child and family services must be done in accordance with principles set out at the national level, including the principle of the best interests of the child. It includes a set of factors to be considered when making this determination, including the child's needs and the child's preferences. This child welfare legislation is an example of legislation that supports Indigenous groups, communities or people to determine their own solutions for their children and families. It provides for the exercise of this jurisdiction, resulting in First Nations, Inuit and Métis laws prevailing over federal laws and laws of provinces and territories (in situations where the group, community or people requests to enter into a tripartite agreement with the federal government and the relevant provinces and territorial governments). For further detail, see: Affirming and recognizing Indigenous jurisdiction over child and family services: An Act respecting First Nations, Inuit and Métis children, youth and families https://www.canada.ca/en/indigenous-services-canada/news/2019/06/an-act-respecting-first-nations-inuit-and-metis-children-youth-and-families-has-received-royal-assent.html.

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New proposed legislation ( Bill C-61, An Act respecting water, source water, drinking water, wastewater and related infrastructure on First Nation lands, see: https://www.parl.ca/DocumentViewer/en/44-1/bill/C-61/first-reading) affirms the inherent right of First Nations to self-government, which includes jurisdiction in relation to drinking water, wastewater and related infrastructure on First Nation lands. This proposed legislation sets out principles, such as reliable access to water services and substantive equality, to guide the provision of clean and safe drinking water for First Nations and the effective treatment and disposal of wastewater on First Nation lands. It would establish minimum national standards for the delivery of drinking water and wastewater services on First Nation lands, based on First Nation choice (that is, the First Nations governing body can choose to meet the Guidelines for Canadian Drinking Water Quality or the drinking water standards of the province or territory where their lands are located). For further detail, see: Bill C-61: First Nations Clean Water Act (short title), or an Act respecting water, source water, drinking water, wastewater and related infrastructure on First Nation lands https://www.canada.ca/en/indigenous-services-canada/news/2023/12/bill-c--first-nations-clean-water-act-short-title-or-an-act-respecting-water-source-water-drinking-water-wastewater-and-related-infrastructure-on-f.html.

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Attorney General of Québec, et al. v. Attorney General of Canada, et al. , 2024 SCC 5. See: https://decisions.scc-csc.ca/scc-csc/scc-csc/en/item/20264/index.do.

Return to footnote 29 referrer

A micro-cultivation licence allows licence holders to produce cannabis plants and seeds, fresh and dried cannabis within a grow surface area (plant canopy) of up to 200 square metres. A micro-processing licence allows licence holders to produce all types of cannabis; these licence holders can possess up to 600 kilograms of dried cannabis (or its equivalent amount) in a calendar year.

Return to footnote 30 referrer

Statistics Canada. (2023). Detailed household final consumption expenditure, provincial and territorial, annual (x 1,000,000) . Retrieved from: https://www150.statcan.gc.ca/t1/tbl1/en/cv.action?pid=3610022501.

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Separate from Health Canada's cannabis licensing regime, under the excise duty framework, companies that cultivate, produce or package cannabis must obtain a Canada Revenue Agency cannabis licence, with corresponding obligations to report and pay taxes. For more information, see: https://www.canada.ca/en/revenue-agency/campaigns/cannabis-taxation.html.

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Farmgate programs allow a licensed processor of cannabis to operate a retail storefront that allows customers to purchase cannabis products directly from the processor.

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Tax policy, including excise taxes, is developed and evaluated by Finance Canada.

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At the time of legalization, the retail price of dried cannabis was approximately $10 per gram. Retail prices have decreased substantially over time and consequently, the excise tax represents a larger share of the price.

Return to footnote 35 referrer

Return to footnote 36 referrer

Cannabis biomass generally refers to the stalks, stems and leaves of the plant.

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In developing this program, the department should establish social equity eligibility criteria to ensure the program is not exploited (such as through the provision of false information or the misrepresentation of eligibility) by those not from under-represented groups.

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Health Canada requires applicants to submit evidence that demonstrates that they have a site which is fully built and meets all applicable requirements of the Cannabis Regulations at the time of application. See: https://laws-lois.justice.gc.ca/eng/Regulations/SOR-2018-144/FullText.html.

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The Black Entrepreneurship Loan Fund is a partnership between the Government of Canada, Black-led business organizations and the Business Development Bank of Canada providing a total of $160 million to support Black entrepreneurs and business owners. For more information, see: https://ised-isde.canada.ca/site/black-entrepreneurship-program/en/black-entrepreneurship-loan-fund-frequently-asked-questions.

Return to footnote 40 referrer

The legislation that made these amendments is entitled An Act to provide no-cost, expedited record suspensions for simple possession of cannabis. See: https://laws-lois.justice.gc.ca/eng/annualstatutes/2019_20/FullText.html.

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A record suspension is a means of keeping records separate and apart from other criminal records so that they will no longer show up in a criminal record search.

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As of December 2023, the Parole Board of Canada had ordered 798 suspensions, out of approximately 1200 applications received. The Government of Canada had previously estimated that 10,000 Canadians would be eligible.

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The enabling legislation for this process is An Act to amend the Criminal Code and the Controlled Drugs and Substances Act. See: https://laws-lois.justice.gc.ca/eng/annualstatutes/2022_15/FullText.html.

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A record sequestration is similar to a record suspension, in that it keeps records separate and apart from other criminal records so that they will no longer show up in a criminal record search. However, sequestrations are automatic; that is, they do not require applications.

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More information on the legislative and regulatory measures that control access to cannabis for adults of legal age can be found in Chapter 5.

Return to footnote 46 referrer

Pepin, L. C., Simon, M. W., Banerji, S., Leonard, J., Hoyte, C. O., & Wang, G. S. (2023). Toxic Tetrahydrocannabinol (THC) Dose in Pediatric Cannabis Edible Ingestions. Pediatrics , 152(3). https://doi.org/10.1542/peds.2023-061374.

Return to footnote 47 referrer

Ingestible cannabis extracts refers to a subcategory of products with some characteristics that are similar to edible cannabis products. In 2023, Health Canada issued guidance for licence holders to help them determine whether products are considered edible cannabis, and thus subject to a limit of 10 milligrams of THC per package, or extracts, which have a limit of 1000 milligrams of THC per package, but more restrictions on the ingredients that can be used to manufacture them. See Classification of edible cannabis for more information https://www.canada.ca/en/health-canada/services/cannabis-regulations-licensed-producers/classification-edible-cannabis.html.

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Hammond, D., Corsetti, D., Fataar, F., Iraniparasat, M., Danh Hong, D., Burkhalter, R. (2023 ). International Cannabis Policy Study – Canada 2022 Cannabis Report . June 2023. Retrieved from https://cannabisproject.ca/wp-content/uploads/2023/06/2022-Canada-Report-June-26.pdf.

Return to footnote 49 referrer

Wadsworth, E., Rynard, V., Driezen, P., Freeman, T. P., Rychert, M., Wilkins, C., Hall, W., Gabrys, R. & Hammond, D. (2023). Legal sourcing of ten cannabis products in the Canadian cannabis market, 2019–2021: a repeat cross-sectional study. Harm Reduction Journal , 20, 19. https://doi.org/10.1186/s12954-023-00753-6.

Return to footnote 50 referrer

More information on these measures can be found in Chapter 5.

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Law enforcement is responsible for enforcing the criminal offences set out in the Cannabis Act , such as offences related to unauthorized sale or unauthorized production. These criminal offences carry the full range of criminal sanctions, including incarceration, as described in Chapter 5. In comparison, Health Canada is responsible for regulatory enforcement, which involves monitoring the compliance of licence holders and other regulated parties with rules that relate to their authorized activities (for example, rules related to how products must be labelled). Regulatory enforcement tools include warning letters, public advisories, product recalls, administrative monetary penalties, licence suspensions and licence revocations.

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According to the Canadian Substance Use Costs and Harms 2007-2020 report, cannabis-related costs of policing, courts and correctional services fell from $1.6 billion in 2017 to just over $1 billion in 2020. See: https://csuch.ca/documents/reports/english/Canadian-Substance-Use-Costs-and-Harms-Report-2023-en.pdf.

Return to footnote 53 referrer

Statistics Canada. (2024). Detailed household final consumption expenditure, Canada, quarterly (x 1,000,000) . Retrieved from https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=3610012401.

Return to footnote 54 referrer

Health Canada. (2024). Canadian Cannabis Survey 2023 Data Tables. Retrieved from https://epe.bac-lac.gc.ca/100/200/301/pwgsc-tpsgc/por-ef/health/2023/149-22-e/index.html.

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Government of British Columbia. (2023). Community Safety Unit - cannabis enforcement . Retrieved from https://www2.gov.bc.ca/gov/content/safety/public-safety/csu.

Return to footnote 56 referrer

The public possession limit for medical purposes is up to 150 grams of dried cannabis or its equivalent in other classes of cannabis, compared to the 30 gram public possession limit for adults.

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In this case a health care professional means a medical practitioner or nurse practitioner.

Return to footnote 58 referrer

Health Canada. (2024). Data on cannabis for medical purposes. Retrieved from https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/research-data/medical-purpose.html.

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Health Canada. (2023). Unpublished analysis of data on cannabis for medical purposes .

Return to footnote 60 referrer

Health Canada. (2024). The Canadian Cannabis Survey 2023. Retrieved from https://epe.bac-lac.gc.ca/100/200/301/pwgsc-tpsgc/por-ef/health/2023/149-22-e/index.html.

Return to footnote 61 referrer

Veterans Affairs Canada. (2022). Veterans Affairs Canada Statistics – Facts and Figures, Health Care Programs. Retrieved from https://www.veterans.gc.ca/eng/about-vac/news-media/facts-figures/5-0.

Return to footnote 62 referrer

In this context, the term surveillance refers to the systematic collection, analysis and reporting of data (including data about the market and industry) related to public health and public safety consequences of cannabis and cannabis use.

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