he Canadian Annual Meeting Keynote on the Canadian government’s economic strategy table jointly delivered by Jennifer Chan (Merck Canada, Inc.), David Lee (Health Canada), Scott Smith (Canadian Chamber of Commerce), and chaired by Kristin Willemsen (Consumer Health Products Canada) led into a focused discussion of Regulatory Modernization in the Health and Biosciences Sector.

Key Takeaways

• Health context is evolving with more tailored medicines, advancements in cell therapies, and new incorporations of technology into health therapies.
• Health Canada heard from stakeholders that greater regulatory flexibility and risk-based approaches are needed to reduce barriers to innovation.
• Commitments were made in the Health and Biosciences Regulatory Review Roadmap and in the 2019 Federal Budget to address barriers through regulatory modernization in key areas.
• The dual objectives of these regulatory modernization efforts are to stimulate and provide better access to safe products for Canadians.

Health context continues to evolve: Opportunity for innovative change

Many treatment options available today were not imaginable when the Canadian food and drug regulatory system was created in the previous century. New products such as cell therapies, new technologies such as bio-printing or artificial intelligence, and personalized therapies delivered in novel ways or made outside of traditional production settings (i.e., at the point of care) challenge current health product regulatory frameworks.

Throughout development of the 2019 Regulatory Review Roadmap, Health Canada engaged with stakeholders to identify legislative and regulatory amendments focused on supporting innovation while delivering its health and safety mandate for Canadians. Enabling legislative authorities were sought and approved through the 2019 Budget Implementation Act which allocated funding to support modernizations. Modernization efforts will focus on making more flexible regulations for clinical trials and advanced therapeutic products so that new biomedical innovations are accessible to Canadians and regulated under appropriate requirements.

Modernizing the Clinical Trials Framework

While existing regulations have served their function well, drivers such as increasingly complex trial types and designs, innovative products, and opportunities for greater use of technology in trials, continue to push for the need for change.

Health Canada received new legislative authorities to make regulatory changes that will enable more flexible and risk-based oversight of new and emerging clinical trial types and designs, such as platform or virtual trials. The regulations also require greater transparency around clinical trial information.

In addition, Health Canada has already taken early action to reduce administrative burden for off-label use of marketed drugs in clinical trials where the product is not the investigational product and is used according to best clinical practices.

Health Canada is currently working on additional policy and regulatory development, with the goal of consulting stakeholders within the next year.

Pathway for Advanced Therapeutics?

Some innovative therapeutic products are so novel and complex that they may not fit under the current regulatory frameworks for drugs and devices. New authorities in the Food and Drugs Act allow the Minister to add a product or product class to a Schedule of Advanced Therapeutic Products based on considerations of certain factors, including the degree of uncertainty regarding the risks and benefits of a product, the extent to which the product is different from other already authorized products, and the adequacy of existing legal frameworks.

When an advanced therapeutic product (ATP) candidate is identified, Health Canada will conduct broad engagement with stakeholders to determine appropriate oversight requirements for the product(s) or class of products. Working in an iterative and collaborative manner with stakeholders, tailored requirements for authorization will be developed and the product will be added to Schedule G. Under Schedule G there will be two modes of access: The first would be that a sponsor would submit an application based on the tailored requirements to receive a licence. The other is an order of permission, where Health Canada would not receive an application; however, use would be limited to persons included in the order and must be as described in that order. The application of terms and conditions would be available under either mode of access. Additionally, when a product is on the Schedule, the tailored requirements can be revised as needed.

The ultimate objective is to determine the best regulations and to take the knowledge gained in the regulatory sandbox and apply it to the regulatory development process. This is accomplished either by drafting new regulations or by amending existing regulations that would allow the ATP to be properly regulated by the various sets of regulations.

The ATP pathway presents a unique opportunity for more innovative products to be licensed through different regulatory approaches to meet the bar of safe, effective, and quality health products.

Modernized Inspector Authorities

The Food and Drugs Act inspector authorities were amended to enable more flexible and agile approaches to inspections. These revisions bring authorities in line with other more modern pieces of legislation. Some new authorities expand on existing compliance authorities to capture a modern suite of activities such as allowing for virtual inspection, tailored risk-management tools, and requiring information without being physically present. Modern inspector authorities will allow compliance and enforcement to better respond to a rapidly evolving health products landscape, particularly for innovative products.

Moving Forward

Health Canada is advancing its policy work to advance agile regulations for clinical trials and advanced therapeutic products. Consultation with stakeholders will continue as these projects evolve to seek feedback on proposed approaches going forward. Exploration into a concierge service to better help innovators navigate the Health Canada’s regulatory system and new pathway for advanced therapies is also underway.