This notice provides interested stakeholders with the opportunity to comment on Health Canada’s intent to amend the Cannabis Regulations (CR) and associated regulatory frameworks to facilitate non-therapeutic cannabis research involving human participants and cannabis testing (Part 1).

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Canada Gazette, Part I, Volume 154, Number 50: GOVERNMENT NOTICES

December 12, 2020

 

DEPARTMENT OF HEALTH

CANNABIS ACT

Notice of intent — Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues

Introduction

This notice provides interested stakeholders with the opportunity to comment on Health Canada’s intent to amend the Cannabis Regulations (CR) and associated regulatory frameworks to facilitate non-therapeutic cannabis research involving human participants and cannabis testing (Part 1).

This notice also provides interested stakeholders with the opportunity to provide feedback and comment on additional regulatory issues: namely public possession limit amounts (i.e. the amounts of various classes of cannabis that are equivalent to 1 gram of dried cannabis, as set out in Schedule 3 to the Cannabis Act); product labelling; micro class and nursery licences; and COVID-19 measures (Part 2).

PART 1: Proposed regulations amending the Cannabis Regulations and associated regulations to facilitate non-therapeutic cannabis research involving human participants and cannabis testing

Background

The Cannabis Act (the Act) creates a strict legal framework for the production, distribution, sale, import, export and possession of cannabis in Canada. Among the objectives of the Act are enhancing public awareness of the health risks associated with cannabis use and providing access to a quality-controlled supply of cannabis.

To help achieve these objectives, Health Canada established a licensing framework to authorize research and development, and testing activities with cannabis under the CR. This included establishing a dedicated research licence class that authorizes activities with cannabis for the purpose of research, as well as authorizing federal licence holders to conduct research and development activities as part of the activities authorized under their licences. Similarly, the authorized activities of government laboratories referred to in section 4 of the CR and the analytical testing licence class permit cannabis testing activities (e.g. for contaminants, cannabinoid content). Other licence holders may also conduct their own testing activities if authorized under their licence, subject to certain conditions.

Under the Cannabis Exemption (Food and Drugs Act) Regulations (CER), cannabis, as defined in the Act and in relation to an activity conducted in accordance with the Act, is exempt from the application of the Food and Drugs Act (FDA) under specific conditions. Cannabis is not exempt from the FDA where it is sold to be used for the purpose of a clinical trial as defined in the Food and Drug Regulations (FDR) [i.e. investigations involving human participants for certain purposes] or an experimental study as defined in those Regulations. Currently, research activities with cannabis involving human participants that meet the definition of clinical trial must meet the relevant requirements of both the CR and the FDR in order to be authorized.

Health Canada recognizes that conducting research involving human participants with cannabis is critical to generating high-quality evidence to provide adult Canadians with the necessary knowledge to make informed decisions on their consumption of cannabis and its risks. Health Canada is aware that researchers are interested in studying the psychological and physiological effects of commercially available cannabis products from a non-therapeutic perspective. Non-therapeutic studies can include investigating the time to onset or duration of effects of a cannabis product, the impact of cannabis use on driving performance, or various other types of public health research. Health Canada is also aware of academic and industry researchers facing challenges in conducting non-therapeutic research involving human participants with cannabis products that are commercially available due to having to comply with the clinical trial requirements under Division 5 of Part C of the FDR.

Regulatory proposal

Health Canada is considering proposing amendments to the CR and associated regulatory frameworks to facilitate non-therapeutic research with cannabis involving human participants, and to facilitate testing activities with cannabis. The proposed amendments would

• (1) Facilitate non-therapeutic cannabis research involving human participants by
  • implementing appropriate health and safety controls, and
  • broadening adverse reaction reporting, where necessary; and
• (2) Streamline and rationalize the licensing framework under the CR to facilitate cannabis-based testing activities, including
  • expanding production, distribution, and sale activities with cannabis reference standards and test kits, and
  • expanding the acceptable qualifications of the “head of laboratory.”

In recognition that Division 5 of Part C may not be ideally suited to regulate non-therapeutic cannabis research involving human participants, Health Canada is considering amendments to the CR, the CER and the FDR to regulate studies of this nature exclusively under the Act and the CR. The regulatory changes would include appropriate public health and public safety controls, as well as controls to ensure the integrity of research findings. Among these controls, the Department is considering proposing amendments to broaden adverse reaction reporting to include licence holders conducting cannabis research involving human participants for non-therapeutic purposes.

Additional related amendments are being considered to the licensing framework under the CR to better support cannabis-based testing activities. Cannabis reference standards play a vital role in assisting laboratories in accurately testing different product characteristics and validating the accuracy of their testing methods, which contribute to maintaining a quality-controlled supply of cannabis products. Reliable testing results help build consumer and industry confidence that the cannabis products available on the retail market are quality controlled and properly labelled (e.g. cannabinoid content is within the labelled amount). Research and analytical testing licence holders, as well as government laboratories referred to in section 4 of the CR, are currently authorized to conduct limited activities with cannabis reference standards (e.g. possess, distribute), but they are not permitted to sell these products. In order for them to do so, they need to obtain a processing licence and comply with good production practices (GPP). GPP requirements are not necessary for reference standards, as they are not intended to be sold to consumers. Therefore, Health Canada is considering exempting licence holders and government laboratories from the GPP requirements when they conduct activities with reference standards. Health Canada also intends to authorize research and analytical testing licence holders, as well as government laboratories, to produce cannabis test kits, and produce and sell cannabis reference standards. The CR already authorizes the sale of test kits.

In addition, Health Canada is considering expanding the acceptable qualifications for a “head of laboratory” (the individual responsible for testing activities). This proposed change intends to help ensure that qualified individuals with sufficient experience and a range of different academic credentials would be eligible to hold this position.

Questions to guide input from interested parties

Below are key questions for which Health Canada is particularly interested in receiving input. However, all input is welcome and should not be limited to responses to these questions. Please provide a rationale and/or evidence to support your views wherever possible.

• 1. How likely would you conduct non-therapeutic cannabis research involving human participants? How many studies do you envision conducting in a year?
• 2. Should the requirements to conduct non-therapeutic cannabis research involving human participants under the CR be similar to those that currently apply to clinical trials under the FDR (e.g. protocol review by a research ethics board, submission of extensive quality [chemistry and manufacturing] information, review of written informed consent, and submission of an investigator’s brochure)? If the requirements should differ, how?
• 3. Should non-therapeutic research involving human participants be restricted to certain participants (e.g. exclude individuals with previous/current mental health or substance use disorders, age restrictions)?
• 4. Should there be restrictions on the types of cannabis used in non-therapeutic cannabis research involving human participants? If so, under what circumstances? What should the quality requirements be for cannabis derived from synthetic sources?
• 5. Should there be restrictions on the dosage, frequency, duration and route of administration (e.g. smoking or vaping) of cannabis used in non-therapeutic cannabis research involving human participants?
• 6. Should adverse reaction reporting for non-therapeutic cannabis research involving human participants be treated in a similar manner as adverse reaction reporting for clinical trials under the FDR? Why or why not?
• 7. What are your thoughts on expanding the production, distribution and sale activities of cannabis reference standards and test kits? What are the potential risks and benefits of this approach (e.g. by exempting reference standards from GPP requirements)?
• 8. Are there any impediments stemming from the current requirements for the “head of laboratory” under the CR?

PART 2: Feedback on additional regulatory issues

In addition to seeking input from interested stakeholders on Health Canada’s intent to propose amendments to the CR and associated regulatory frameworks to facilitate non-therapeutic cannabis research involving human participants and cannabis testing, Health Canada is also seeking input on the topics below. There are key questions after each topic for which Health Canada is particularly interested in receiving input. However, all input is welcome and should not be limited to responses to these questions. Please provide a rationale and/or evidence to support your views wherever possible. The responses will help inform potential future regulatory development and will be reviewed carefully by Health Canada.

Public possession limit

Under the Act, individuals 18 years of age and older are prohibited from possessing in public more than 30 grams of dried cannabis or its “equivalent” for non-dried forms of cannabis. Schedule 3 to the Act sets the amounts of various classes of cannabis that are considered equivalent to 1 gram of dried cannabis. These amounts generally align with U.S. jurisdictions that have legalized and regulated cannabis for non-medical purposes.

To help individuals comply with the public possession limit, the CR require that all cannabis products for retail sale, except for dried cannabis or a cannabis plant, be labelled with a statement indicating the amount of dried cannabis the product would be equivalent to (i.e. a public possession statement).

In public opinion research conducted in February 2020 by Health Canada, many participants were generally aware that there is a limit for the amount of cannabis that an adult can possess in public, however, very few were aware of what that limit actually is. The public possession statement on product labels was often misunderstood, and many participants in the public opinion research did not associate it with an indication of the public possession limit. Rather, this information was misinterpreted as either serving as a guide of product strength or as a benchmark enabling cost comparison between different cannabis products.

As well, some stakeholders have suggested that the public possession limits for non-solids containing cannabis (e.g. cannabis beverages) are too low, and that the public possession limits are encouraging consumers to purchase higher potency cannabis beverages.

• 9. Do you think the public possession statement on cannabis product labels helps adults comply with the public possession limit?
• 10. Currently, the CR require labels to display a statement to express the amount of cannabis a product is equivalent to in terms of grams of dried cannabis. Do you see any issues with this approach? Are there any benefits or challenges you think an adult may have in interpreting this information on different kinds of cannabis products (e.g. edible cannabis, cannabis topicals, vaping products, etc.)?
• 11. Do you think the current public possession limit for cannabis beverages (which is currently approximately 2 litres) should be increased? If yes, please explain what you think an appropriate public possession limit would be for these products and why.

Product labelling

Cannabis contains hundreds of chemical substances, including cannabinoids (such as tetrahydrocannabinol [THC] and cannabidiol [CBD]) and terpenes. The CR require that product labels indicate the quantity or concentration of the THC and CBD in cannabis products. Licence holders may choose to display the name, quantity or concentration of other cannabinoids and terpenes in the product, provided that the labelling and packaging comply with the CR.

• 12. Should Health Canada require product labels to display information about other cannabinoids and terpenes (e.g. quantity or concentration)? Why or why not? If yes, which cannabinoids and terpenes and why?
• 13. Is there any other labelling information that would help consumers make decisions to support informed and responsible use?

Micro class and nursery licences

The CR sets out a licensing framework intended to enable a diverse, competitive legal industry that is comprised of a range of market participants, including both small and large players.

Three of the licence subclasses — micro-cultivation, micro-processing, and nursery — are intended to enable the participation of small-scale players. The micro-cultivation and micro-processing licences authorize the same activities as a licence for standard cultivation and standard processing respectively, but at a smaller scale. The nursery licence is intended to enable a legal source of starting materials (both for commercial and personal cultivation), and the development of new varieties of high quality cannabis.

These licences are subject to reduced regulatory requirements (e.g. in the area of physical security), which reflects the level of risk related to the scale of the operation.

• 14. Are the regulatory requirements for the micro-cultivation, micro-processing and nursery licences (e.g. cultivation and processing limits) appropriate given their scale?
• 15. Are there any elements of the regulatory framework that put micro-cultivation, micro-processing and nursery licence holders at a competitive disadvantage compared to larger companies? If so, how, and what adjustments would you propose?

COVID-19 measures

Since April 2020, Health Canada has put in place measures to support cannabis licence holders with operational and logistical difficulties that they may be facing due to the COVID-19 pandemic. These include, among others, accepting a packaging date that is within four (4) days of the printed packaging date on the label (provided appropriate records are kept), enabling the destruction of cannabis to be witnessed virtually and simplifying the requirements for the presence of a security cleared person accompanying cannabis being treated at an external destruction or irradiation facility. These measures are in place until March 31, 2021.

• 16. Are there any measures that should be made permanent? What would be the impact if these measures were not continued? Are there any risks of making a measure permanent and how should they be mitigated?

Conclusion

The publication of this notice in the Canada Gazette, Part I, initiates a 30-day comment period. Health Canada is seeking feedback and comments to ensure that the proposed regulatory amendments with respect to cannabis research and testing are informed by and responsive to the cannabis industry, cannabis researchers, other relevant stakeholders and the public. The Department is also interested in views on a variety of other aspects related to the regulatory framework. Any inquiries or comments for this notice must be sent by email to cannabis.consultation@canada.ca stating the title of this notice (Notice of intent —Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues) in the subject line.

John Clare
Director General
Strategic Policy, Cannabis
Controlled Substances and Cannabis Branch

DEPARTMENT OF HEALTH

CONTROLLED DRUGS AND SUBSTANCES ACT
FOOD AND DRUGS ACT

Notice of intent to amend the Food and Drug Regulations and the Narcotic Control Regulations to restore potential access to restricted drugs through Health Canada’s Special Access Program

This notice provides interested parties and the general public with the opportunity to comment on Health Canada’s intention to reverse regulatory changes made to the Food and Drug Regulations (Parts C and J) and the Narcotic Control Regulations in 2013, which prohibited access to restricted drugs through the Special Access Program and added unauthorized products containing cocaine to the definition of restricted drug.

Background

The Controlled Drugs and Substances Act (CDSA) and its regulations provide a framework for the control of substances (also known as “controlled substances”) that can alter mental processes and that may produce harm to an individual or to society when misused or diverted to an illicit market. The CDSA prohibits any person from conducting activities (such as possession, production, sale, import and export) with controlled substances unless authorized by regulation or through an exemption granted under the CDSA. Regulations under the CDSA provide for the legitimate use of controlled substances, such as their use in approved prescription drugs. Under the CDSA, there are multiple different categories of controlled substances. Restricted drugs are controlled substances that are listed in the Schedule to Part J of the Food and Drug Regulations (FDR).^footnote1 Restricted drugs have no approved medical uses, and can only be used for scientific or research purposes.

Because of their biological effects, controlled substances also meet the definition of “drug” under the Food and Drugs Act (FDA), and are therefore also subject to the FDA. Under the FDA, the importation and sale of any drug is prohibited unless, subsequent to Health Canada’s established drug review and approval process, a Notice of Compliance has been issued or a Drug Identification Number (DIN) has been assigned. Access to drugs that have not yet been approved for sale in Canada can also be provided through an approved clinical trial or through Health Canada’s Special Access Program (SAP). Practitioners treating patients with serious or life-threatening conditions can request access to drugs that have not yet been approved for sale in Canada through the SAP when conventional therapies have failed, are unsuitable, or unavailable. Requests to the SAP are considered on a case-by-case basis, taking into consideration the level of scientific evidence (including evidence pertaining to safety, efficacy, and quality) to support the use of the drug for the treatment of the patient’s specific condition.

As a result of regulatory amendments made to the FDR in 2013, access to restricted drugs through the SAP is currently prohibited. The 2013 regulatory amendments included

• 1. Amending section C.08.010 of the FDR to prohibit access to restricted drugs through the SAP; and
• 2. Amending the definition of “restricted drug” in Part J of the FDR to include any cocaine products that are not otherwise authorized by Health Canada to be sold on the market, are not within the context of an approved clinical trial, or are not being compounded by a pharmacist by prescription.

While restricted drugs do not have approved medical uses, regulations under the CDSA allow for their use for scientific or research purposes, including their use in clinical trials.^footnote2 Since these regulatory changes were made in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has continued to advance. Certain restricted drugs are now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials.

As a result of the 2013 regulatory amendments, under the FDA, the only mechanism by which the sale of a restricted drug can be authorized for the treatment of patients is through participation in an approved clinical trial. While clinical trials remain the best mechanism to authorize the sale of restricted drugs (or any other unapproved drug) for the treatment of patients, there may be situations where a patient is unable to participate in one. For example, there may not be any clinical trials currently recruiting for a specific drug or in a specific area of the country. Based on recent scientific advancements and the potential for some restricted drugs to have therapeutic benefit, prohibiting the possibility of restricted drugs being authorized for sale through the SAP removes a potential option for practitioners treating patients with serious or life-threatening conditions in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Objective

As noted in the Regulatory Impact Analysis Statement for the 2013 regulatory amendments, the objective of those amendments was to prevent access to restricted drugs, heroin, and unauthorized products containing cocaine through Health Canada’s SAP. In 2016, these regulatory amendments were partially reversed, allowing for the consideration of applications made to the SAP for diacetylmorphine (i.e. heroin).

Based on recent scientific advancements and the potential for some restricted drugs to have therapeutic benefit, the objective of the current proposal is to restore the possibility of access to restricted drugs through Health Canada’s SAP, by reversing the remaining 2013 regulatory amendments. In practice, this would mean that practitioners could, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Proposal

Health Canada is proposing to reverse the remaining regulatory changes made in 2013, which would remove the current prohibition on access to restricted drugs through the SAP, and would also remove unauthorized products containing cocaine from the definition of restricted drugs.

Removing the prohibition on access to restricted drugs through the SAP

More specifically, Health Canada proposes to repeal subsections C.08.010 (3) and C.08.011.1 (2) in Part C of the FDR, which prohibit the issuance of letters of authorization to a manufacturer for any drug that is or that contains a restricted drug.

Subsections C.08.010 (3) and C.08.011.1 (2) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.^footnote3

Reversing the remaining 2013 regulatory amendments would not guarantee that restricted drugs would be approved through the SAP, but it would treat restricted drugs like all other controlled substances for the purposes of the SAP. As is currently the case, all applications to the SAP would be considered on a case-by-case basis, taking into consideration the level of evidence pertaining to the safety, efficacy, and quality of the drug, as well as the particular needs of the patient. The proposed amendments are not intended to promote or encourage the early use of unapproved drugs, or to circumvent the well-established clinical trial or drug review and approval processes. These amendments could, however, provide an additional potential option for practitioners treating patients with serious or life-threatening conditions in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Removing unauthorized products containing cocaine from the definition of restricted drug

Since 2013, cocaine has been regulated under two different regulations under the CDSA. Any cocaine products that have been authorized by Health Canada to be sold on the market, that are being used within the context of an approved clinical trial, or that are being compounded by a pharmacist pursuant to a prescription are regulated as narcotics, whereas unauthorized products containing cocaine are regulated as restricted drugs.

To simplify regulatory requirements and facilitate compliance with the regulations, Health Canada proposes to reverse the 2013 amendments related to cocaine by

• 1. Repealing part (b) of the definition for restricted drug in section J.01.001 of Part J of the FDR.
  • (b) cocaine (benzoylmethylecgonine) or any of its salts, or a product or compound that contains such a substance, except
    • (i) a drug in dosage form, as defined in subsection C.01.005(3), that has a drug identification number assigned to it under Division 1 of Part C or that is authorized for sale under Division 5 of Part C, and
    • (ii) cocaine (benzoylmethylecgonine) or any of its salts, or a preparation that contains such a substance, that is prepared by a pharmacist in accordance with or in anticipation of a prescription.
• 2. Repealing the exception in subsection 2(2) of the Narcotic Control Regulations, which excludes the above-noted forms of cocaine from the application of the Narcotic Control Regulations.
• 3. Repealing the definitions for “pharmacist” and “prescription,” which were added to Part J of the FDR in 2013 to support the amendments made to part (b) of the definition of restricted drug.

Public comments

The publication of this notice of intent in the Canada Gazette, Part I, initiates a 60-day comment period that will end on February 10, 2021. If you are interested in participating in this consultation, please send written comments to the Office of Legislative and Regulatory Affairs, Controlled Substances Directorate, Controlled Substances and Cannabis Branch, Health Canada. Comments can be sent by email to hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca, or by mail to the Office of Legislative and Regulatory Affairs, Address Locator: 0302A, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9.

Michelle Boudreau
Director General
Controlled Substances Directorate
Controlled Substances and Cannabis Branch

 

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