Regulatory Agility at the Center of Pandemic Management at Health Canada

Nicolas Sacchetti 2023-05-29

Elizabeth Toller, directrice du Secrétariat de l’innovation en soin de santé, à Santé Canada

COVID-19 required an unprecedented public health response, but also confirmed the need for regulatory agility.

At Health Canada, before the pandemic struck, a plan to make the regulatory system agile and responsive to innovation was already in place.

by Nicolas Sacchetti

Elizabeth Toller is the Director of the Health Care Innovation Secretary at Health Canada. She leads the modernization of Food and Drug Regulation to support innovation and competitiveness. She notes that regulation is becoming more complex, given the acceleration of digital technology, the power of AI and many other innovations.

The manager spoke on how Health Canada had to be agile in managing COVID-19 crisis in a panel shared with Kathy Malas (CHUM), Marc St-Hilaire (CAE) and moderated by Annie Martin (CSA). The videoconference took place during the first P4IE Conference on Policies, Practices and Processes related to the Performance of Innovation Ecosystem presented by 4POINT0.

In this context Health Canada wants to be more agile in regulation. In 2019, it received $120 million over five years to advance regulatory innovation. The plan is broken down into five pillars that span the life cycles of regulated products:

  1. Modernize clinical trial regulation
  2. Enabling breakthrough therapeutics
  3. Agile licensing of drugs
  4. Agile licensing of medical devices
  5. Information to Canadians: a mobile strategy

In the area of clinical trials, it has adapted the regulations to support investigational products and to make information about clinical trials more transparent. In response to the growing range of complex products, Health Canada is working to establish a new pathway for breakthrough therapeutic products that face barriers to market entry because they simply do not fit into the current regulatory system.

Interim Prescriptions

In the early days of the pandemic, it had to innovate in order to create emergency approval pathways for procuring spread prevention products. Health Canada introduced interim orders. This regulatory tool provided more agility to expedite procurement processes without compromising efficiency, quality, and people's safety.

The government agency has expanded the range of specialists who can conduct clinical trials and use modern regulatory tools, such as conditions of approval, to effectively manage the risks and uncertainties of products for approval. "We have also supported an expedited review, allowing the use of submissions for vaccines and treatments. Then, we can accept evidence and information from companies as soon as it's ready, instead of waiting until the end when the full submission is complete," Toller explains.

This temporary regulatory relaxation has obviously played a key role in the response to the pandemic. It also reinforced the importance of Health Canada being an agile regulator and was also a learning opportunity for future modernization plans.

Collaboration

In the early days of the pandemic, Health Canada took the initiative to reach out to business leaders to identify promising solutions to the pandemic. They were told that the regulations were flexible and that their submissions were welcome.

Health Canada also brought together industry players, as well as other Federal decision makers to unblock supply chain issues. Whether it was research funding, border challenges, manufacturing capacity or supply issues. It has also put a lot of energy into communication, dealing with a lot of new players who have started to supply Canadians with the necessity products. Whether it's liquor companies producing hand sanitizer or non-traditional companies making gowns, face shields or ventilators.

Toller believes that Health Canada could do more to help innovators navigate this complex regulatory system. Moreover, she points out the greatly increased international collaboration in the context of the pandemic to achieve global regulatory consistency.

"COVID-19 has reinforced the importance of being a flexible and globally connected regulator. We remain committed to advancing our modernization priorities and goals by building on the experience we have gained." - Elizabeth Toller

This content has been updated on 2023-05-31 at 20 h 55 min.