Health Canada is consulting stakeholders on the expansion of non-therapeutic cannabis research involving human participants. Input is also being solicited on a host of other regulations, including public possession, product labeling, micro class and nursery licensing, and COVID-19 measures1. Stakeholders have until January 11, 2021 to provide their comments on these issues.
What you need to know
Health Canada proposes to amend the Cannabis Act, the Cannabis Regulations and the Food and Drug Regulations so that non-therapeutic cannabis research involving human participants is regulated exclusively under the cannabis legislation.
Regulatory changes would be made to the laws to include appropriate public health and public safety controls, as well as controls to ensure the integrity of research findings such as broadening adverse reaction reporting to include licence holders conducting cannabis research.
Additional regulatory issues such as the public possession limit (its labelling and the limit for non-solid products), product labelling (whether labels should be required to include quantity and concentration of cannabinoids and terpenes) and micro class and nursery licensing issues (whether micro class producers are being put at a competitive disadvantage and measures to address this) are also being considered.
Expanding research pathways
Canada’s legal cannabis industry is still in its infancy, but as it continues to develop so does the federal cannabis regulatory regime and its latest evolution has been focused on the development of a clinical research framework. Reliable testing is needed to help build consumer confidence that the cannabis products on the Canadian retail market and the claims and/or physiological/physiological effects they purport to trigger are supported by quality clinical evidence.
Currently, research activities involving human subjects, whether for therapeutic or non-therapeutic purposes, that meet the definition of a clinical trial must meet requirements of both the Cannabis Regulations and the Food and Drug Regulations (FDR) in order to be authorized. However, industry and academic researchers have found the onerous requirements under the FDR a challenge to meet especially for non-therapeutic research.
Earlier this fall, Health Canada published guidelines clarifying the current obligations for clinical trial sponsors under the FDR for various types of cannabis-based clinical research (for both therapeutic and non-therapeutic purposes)2. However, the present consultation to open up and simplify clinical research requirements is an acknowledgement that the requirements outlined in the FDR are not “ideally suited to regulate non-therapeutic cannabis research involving human participants”.
Related amendments are being considered for cannabis reference standards which assist laboratories in accurately testing different product characteristics and validating testing methods. Changes would include exempting research and analytical testing licence holders from Good Production Practices (GPP) requirements so that their reference standards can then be sold to other licensed parties (at present, only possession and distribution is permitted as GPP is required for sale).
Health Canada is also considering expanding the acceptable job and education qualifications for a “head of laboratory” (the individual responsible for testing activities) so that qualified individuals with sufficient experience and a range of different academic credentials would be eligible to hold this position.
While the Cannabis Regulations do set out a dedicated research licence class for activities with cannabis (and allow for limited research, development and testing by federal licence holders), the current regulatory pathways for research are difficult to navigate and inadequate for certain contexts. With the expanding consumer marketplace and the public seeking more reliable information on their product choices, including time to onset, duration of effect, and impact on driving and personal performance, Health Canada is trying support relevant public health research by establishing a bespoke and comprehensive regime for clinical research on the use and effects of cannabis. This is welcome news for stakeholders involved in research, development and testing in the non-therapeutic context. Since edibles (including beverages) have entered the market, many companies have been expanding their product offerings and creating new innovative formulations. The changes to the regime will provide a more practical way to assess the qualities and effects of their cannabis products.
Feedback on additional regulatory issues
Health Canada is also seeking feedback on potential changes to the labelling requirement to describe the public possession limit.
Currently under the Cannabis Act, adult Canadians can possess no more than 30 grams of dried cannabis or the applicable non-dried equivalent in public. All retail products are required to describe this public possession limit. Studies have suggested that the limit is misunderstood by consumers, particularly with respect to non-dried goods.
Health Canada is seeking general feedback on the labelling requirement for public possession limits, as well as specific feedback on whether the non-dried equivalent labelling is difficult to interpret, and whether the cannabis beverage public possession equivalent of approximately two litres should be increased. Another labelling related proposal is the expansion of labelling requirements for the quantity and concentration of other cannabinoid and terpenes included in products. Health Canada is soliciting stakeholders’ views on why this information should, or should not, be required on the label.
On a separate issue, Health Canada is also seeking feedback generally on the state of the current regime for small scale producers that are licensed under micro-cultivation, processing and nursery licenses. Health Canada wants input on whether the current framework is placing smaller producers at a competitive disadvantage and if the regulatory requirements are appropriate for their scale.
Lastly, measures which were implemented to support license holders with operational and logistical difficulties brought on by the COVID-19 pandemic are set to expire on March 31, 2021. These measures included allowing the destruction of cannabis to be witnessed virtually, simplifying the requirements for the presence of a security cleared person when cannabis is being treated at an external facility, etc. Health Canada is asking license holders whether these measures should be made permanent.
Stakeholders have the opportunity to provide feedback on any of these issues by sending their comments to [email protected] by January 11, 2021 with the subject “Notice of intent —Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues”. We encourage our clients in the cannabis industry to participate in this process and share their feedback with Health Canada.
1 Notice of intent — Consultation on the Cannabis Regulations: Cannabis research and other regulatory issues, Dec. 12, 2020, available here.
2 Notice to Stakeholders – Clarification of Requirements Under the Food and Drug Regulations When Conducting Clinical Research with Cannabis, Sept. 18, 2020, available here.
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This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
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