Drug and medical device highlights 2020: Helping you maintain and improve your health

This past year brought much attention to the role the Health Canada plays as an integral part of the healthcare system. Whether it was for health products such as diagnostic tests for COVID-19, or reviews of new vaccines, the rapid pace of science innovation highlighted the key gatekeeper function of the department. Many people became aware of a regulatory system that had otherwise functioned quietly in the background, assuring that the health products they needed were diligently reviewed and met the high standards for safety, efficacy and quality that underpin all authorization decisions.

Being open and transparent brought into focus the importance of having an independent regulator that based decisions solely on science and evidence, while being flexible and agile to respond to the public health crisis that faced us all. There was interest in the details of the review processes, the competencies and experience of reviewers, the volumes of data that are assessed prior to decisions being made, and the critical role of balancing benefits, risks and uncertainties. Areas such as international cooperation and collaboration were brought to the fore as essential in coming up against a global pandemic.

All of this was in service of ensuring that people could have faith and confidence in the regulatory role and they could be assured that those who were making those decisions genuinely had "been training their whole lives for this".

As challenging as the previous year was, one benefit has been this greater understanding of the importance of being able to equip oneself with information from trusted sources to empower people to be able to make the best decisions for their own health and wellbeing. This is as true in "non-pandemic" times as it is now.

The collective challenge to all of us is to continue this sharing of information, innovative practices, and engagement as we go forward.

The COVID-19 pandemic has led to the implementation of a series of extraordinary regulatory measures. These have provided Health Canada with the flexibilities we needed to respond effectively and efficiently to the crisis.

In March, Health Canada was part of the Government's COVID-19 Emergency Response Act. This legislation was enacted to stabilize the Canadian economy and protect Canadians' health and safety. Among other components, the Act gave the Government the authority to make regulations to help prevent or alleviate shortages of drugs and medical devices. This helped facilitate access for Canadians to supplies of drugs and medical devices, including personal protective equipment, that were needed to address the public health emergency.

Health Canada also put in place five Interim Orders to respond to the urgent need for access to health products as a result of the COVID-19 pandemic. An interim order is one of the fastest mechanisms available to the federal government to help address larger-scale public health emergencies.

• The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 Archived ensured that medical devices that are integral to the diagnosis, treatment, mitigation or prevention of COVID-19 could be quickly authorized for sale or importation while maintaining high scientific standards. It allowed Health Canada to impose terms and conditions on the authorization of a medical device under the Interim Order, so that we could act quickly to collect information or take action to mitigate risks associated with a product.
• The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 Archived allowed the Minister to permit the exceptional importation and sale of drugs and medical devices experiencing a shortage in Canada that were approved in other countries with comparable approval systems. Additionally, the Interim Order introduced a mandatory mechanism for the Minister to be notified of shortages of critical medical devices. Finally, the Interim Order allowed for the expedited authorization of hard surface disinfectants and hand sanitizers.
• The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Archived allowed the authorization process for COVID-19-related clinical trials to be more efficient and flexible, without compromising the safety of participants or the reliability of trials' findings. This flexibility also facilitated broader patient participation across the country by allowing a wider range of health professionals or investigators to be involved in carrying out clinical trials. For example, the Interim Order allowed for remote patient consent; this was not only critical during the pandemic but in the future it could become a policy to help patients participate in clinical trials from more remote communities.
• The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 introduced expedited authorization pathways for the importation, sale and advertising of drugs (human and veterinary) used in relation to COVID-19. The Interim Order established expedited processes including rolling submissions, where companies provide data to Health Canada as it becomes available. Companies must continue to demonstrate that their drugs (including vaccines) are safe, effective and of high quality. Health Canada can impose terms and conditions on the authorization of a drug, allowing us to act quickly to gather important safety information or mitigate risk.
• The Interim Order on Preventing and Alleviating Drug Shortages in Relation to COVID-19 provided Health Canada with more tools to urgently address drug shortages related to COVID-19. This authority will help safeguard Canada's drug supply and ensure that Canadians have access to the medicines they need.

In 2020 we also finalized changes to the Food and Drug Regulations to modernize the Special Access Program for human drugs, and the Emergency Drug Release program for drugs for veterinary use. These changes improved the processes used by health care providers and reduced the administrative burden for requests to access drugs that are not yet authorized for sale in Canada, for COVID-19 and other medical emergencies.

In order to appropriately implement a life-cycle approach for medical devices, Health Canada required additional authorities to monitor devices once they are on the market. Vanessa's Law amended the Food and Drugs Act to strengthen our ability to collect post-market safety information and take appropriate action when needed. In 2020 we published regulations relating to the post-market surveillance of medical devices, which implemented certain provisions of Vanessa's Law and additional measures to improve post-market surveillance. Together these efforts have helped to reduce the risk of medical devices and improve their safety, quality and effectiveness.

Our regulatory work in 2020 has focused primarily on Health Canada's urgent response to the COVID-19 pandemic. We will continue our work to maintain the flexibilities and regulatory oversight provided by the Interim Orders until at least the fall of 2021. By then, Health Canada intends to bring forward regulatory amendments that would allow for the transition of products already authorized so that they can continue to be sold.

Moving forward, we will turn our attention back to the activities we had previously planned, related to regulatory innovation. We will continue to build on the lessons learned from our regulatory response to COVID-19 to shape our new, agile regulatory frameworks.