As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health Canada is consulting on what it should consider in developing regulations for clinical trials and implementing the approval pathway for ATPs until August 30, 2019.
The BIA received Royal Assent on June 21, 2019. The changes to clinical trial regulation will come into force once new regulations are developed and implemented. While the ATP provisions from the BIA are now in force as part of the Food and Drugs Act, Health Canada is consulting on how to best implement them.
In the context of the consultation, Health Canada has published a discussion paper entitled Agile regulations for advanced therapeutic products and clinical trials (the Discussion Paper). This paper is premised on the idea that some Health Canada regulations for drugs and medical devices have not kept pace with innovation. The paper describes an “ambitious regulatory reform agenda” in order to accommodate highly complex technology while still protecting the health and safety of Canadians.
The Discussion Paper indicates that the current “one-size-fits-all” approach to clinical trials may discourage certain types of studies, and may poses challenges to small and medium sized companies. The intention of the new regulatory framework is to:
- allow for new types of trials;
- decrease cost for low-risk trials and regulate in proportion to risks; and
- improve alignment with global partners and increase Canada’s competitiveness in attracting trials.
Health Canada intends to expand its focus in order to control the conduct of all parts of a clinical trial. It will expand the use of evidence gathered through trials. It will also give patients greater access to information on available clinical trials and to the results of these trials.
Health Canada also intends to expand the clinical trials framework to include studies of food for special dietary purposes (e.g., infant formula). Currently, it is not possible to conduct clinical trials with these foods in Canada.
Advanced Therapeutic Products
The Discussion Paper indicates that most products will continue to be regulated via one of the existing pathways, rather than as ATPs. The new ATP pathway is being created for exceptional circumstances where drugs or devices are “so novel, complex, and distinct that current regulations are not equipped to handle them” (e.g., gene editing).
Health Canada envisions a flexible pathway with a “concierge service” that provides a flexible, risk-based way to authorize products while protecting the health and safety of Canadians. Under the new pathway, Health Canada will consult with stakeholders and consider:
- The risks and benefits associated with the product, and steps available to adequately manage and control these risks.
- The extent to which the product is different from already approved drugs or devices.
- The extent to which there are other appropriate controls in place, e.g., through provincial and territorial legislation.
ATPs will be authorized either by (1) licence (with associated terms and conditions) or (2) an order of permission (more suitable for lower-risk products). In both instances, Health Canada would aim to ensure that the ATP meets market licensing and health technology assessment requirements.
The paper concludes by providing three questions to guide feedback:
- What products would you want to put forward for consideration under the ATP pathway?
- Can you suggest any good models of an enhanced client “concierge” service that would help companies wishing to be considered for the ATP pathway?
- What recommendations do you have for creating clinical trials regulations that would attract clinical trials in Canada and be an effective model in the Canadian context?
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