Event summary: Health Canada's 2020 virtual stakeholder meeting on health products

December 4, 2020

Theme and Objectives

On December 4, 2020, Health Canada's Health Products and Food Branch (HPFB) held its annual health product stakeholder event.

Over 280 participants from industry associations, academia, innovation incubators and accelerators, patient and consumer groups, health practitioners, advocacy and non-governmental organizations, and other government partners took part in the virtual event.

The theme of this year's event was "Regulatory Agility in Response to COVID-19". The event was an opportunity for HPFB to share with stakeholders how the agile and innovative regulatory measures put in place during the pandemic are supporting Canada's broader response to the crisis. It was also an occasion to thank stakeholders for their collaboration in enabling access to thousands of health products for communities and health care professionals across the country.

The event featured a keynote address discussing the impact of the pandemic on the health and biosciences sector. HPFB senior officials also shared plans to build on lessons learned from COVID-19 as we move forward with our regulatory innovation agenda.

Welcome Remarks

Pierre Sabourin, Assistant Deputy Minister of HPFB, opened the session by acknowledging the impact of the crisis and expressing his gratitude for the remarkable cooperation Health Canada has received from stakeholders in supporting Canada's response to the pandemic. Mr. Sabourin also expressed his gratitude for the vital work of front line health care professionals and the rapid mobilization of the health products sector.

He outlined how the innovation and collaboration we have seen across all disciplines during this crisis has had a strong impact on Canada's public health response. In addition, he explained how agile regulatory measures, proactive engagement with industry, and an unprecedented level of international collaboration led to significant progress towards vaccines and treatments for COVID-19.

Mr. Sabourin stressed that, while Health Canada's focus has been on responding to the pandemic, HPFB continues to authorize many other drugs and medical devices vital to the health and well-being of Canadians.

Opening Remarks

Health Canada's Deputy Minister, Dr. Stephen Lucas, began his remarks by acknowledging the impact of the pandemic on the physical and mental health of all Canadians.

Dr. Lucas emphasized that Health Canada's top priority is to protect the health and safety of Canadians. He explained how Health Canada has been working with partners, across government and abroad, to support the development of medical supplies and health products to test for, treat and prevent COVID-19, as well as to address issues around drug supply and shortages.

Dr. Lucas noted that from the start, the Government of Canada has taken a whole-of-government approach to respond to the pandemic and keep Canadians safe. He acknowledged the unprecedented collaboration between all levels of government, industry and the health care system to respond to the crisis.

His remarks illustrated how the whole-of-government approach has helped save Canadian lives, protect the health of Canadians, and prevent our health care systems from becoming overwhelmed.

The COVID-19 pandemic created an urgent need for disinfectants, especially hand sanitizers, and personal protective equipment (PPE). Dr. Lucas highlighted HPFB's efforts to increase supply and ensure that Canadians have access to these much-needed products. This work included expediting the review of these products and providing guidance and information to companies so that they could obtain approval to produce and sell alcohol-based hand sanitizers and PPE. These efforts led to rapid mobilization and an increase in products available.

Dr. Lucas further highlighted the Government of Canada's unparalleled efforts to provide every Canadian with access to a safe and effective vaccine to stop the spread of COVID-19. He explained that Health Canada's role as regulator is to review all COVID-19 vaccine candidates for safety, efficacy and quality prior to authorizing them for use in Canada. Health Canada conducted intensive proactive engagement with vaccine manufacturers.

In addition to establishing dedicated review teams, Health Canada introduced the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. This measure sets out agile conditions for reviewing vaccine submissions and information from manufacturers in real time (sometimes referred to as rolling review). Health Canada will accept new evidence as it becomes available until the application is deemed complete. Because the company doesn't wait until everything has been completed, it can expedite review time for these important new drugs without compromising standards of safety, efficacy, and quality.

As a result, Health Canada was the first country in the world with three vaccines under a rolling review. Dr. Lucas underscored that while Health Canada is working hard to give Canadians access to COVID-19 health products as fast as possible, we will not compromise Canada's safety, efficacy and quality standards.

Dr. Lucas' concluded his remarks by acknowledging the tremendous efforts made by all stakeholders in the fight against the global pandemic.

Keynote Address

Karimah Es Sabar, Chief Executive Officer and Partner, Quark Venture LP, and Chair of the Government of Canada's Health and Biosciences Economic Strategy Table (HBEST) spoke about the impact of the pandemic on the health and biosciences sector.

Ms. Es Sabar discussed how COVID-19 has placed a spotlight on the sector, highlighting both its strengths and opportunities for innovation advancement and adoption. She provided an overview of the vision established by HBEST to boost growth in Canada's health and biosciences sector. This vision sees Canada doubling the size of the health and biosciences sector and becoming a top-three global hub by 2025.

In its 2018 report, HBEST's recommendations focused on five key areas to transform the trajectory of the Canadian health and biosciences sector to meet this vision:

• Accelerate innovation adoption – employing value-based procurement across Canada's health systems
• Design agile regulations – adopting international best practices, eliminating duplication across jurisdictions and decreasing review times
• Harness digital technology – creating a national digital health strategy featuring an interoperable digital health platform
• Develop and attract talent – equipping Canadians for highly skilled job, eliminating hiring barriers and streamlining government skills programs
• Create anchor firms – mobilizing late stage capital, scaling up high potential firms, broadening SRED (Scientific Research and Experimental Development) and other incentives

Ms. Es Sabar summarized the progress made under each of the five recommendations and stressed that this progress must be accelerated for the health and biosciences sector to be a post-COVID-19 engine of recovery for the Canadian economy.

Ms. Es Sabar commended the agile measures Health Canada put in place to support Canadian industry in providing timely access to needed health products, and acknowledged the Government of Canada's support for Canadian researchers and life science companies in their efforts to develop innovative solutions to combat COVID-19.

Ms. Es Sabar concluded her remarks by reiterating that the pandemic was an opportunity to re-think and re-establish the new normal, and leverage the health and biosciences sector as an engine for economic growth and improved health outcomes for Canadians.

Presentation and Panel Discussion: Regulatory Agility in Health Canada's Response to COVID-19

Elizabeth Toller, Executive Director of Regulatory Innovation, HPFB, and Dr. Megan Bettle, Director General of the COVID-19 Regulatory Response Team, HPFB, gave a presentation on Health Canada's agile regulatory response to COVID-19 and how these measures impact stakeholders and Canadians.

Dr. Bettle began the presentation by explaining how Health Canada mobilized quickly to support the health care system and help increase access to urgently needed medical supplies to limit the spread of COVID-19 in communities. This was accomplished through agile regulatory and administrative measures to help expedite access to safe and effective COVID-19 products without compromising safety. Health Canada also engaged in proactive outreach to provide guidance, advice and priority information to businesses eager to produce health products to support the COVID-19 response.

Dr. Bettle outlined the temporary regulatory measures – Interim Orders – put in place to provide agility in a time of crisis. Interim Orders have helped to:

• Expedite the review of medical devices, such as testing kits and medical supplies
• Allow for exceptional importation for needed drugs, medical devices and foods for a special dietary purpose
• Facilitate clinical trial for COVID-19 health products in Canada
• Expedite the review of drugs and vaccines for COVID-19
• Prevent and address drug shortages caused directly or indirectly by COVID-19

Health Canada's swift regulatory actions have enabled access to thousands of products for communities and healthcare professionals.

Ms. Toller continued the presentation and underscored Health Canada's commitment to supporting uninterrupted access to COVID-19 health products by maintaining the agile measures and regulatory oversight provided by the Interim Orders, until at least the fall of 2021. She confirmed that Health Canada plans to bring forward regulatory amendments that would allow for the continuation of many of the agile measures after the fall of 2021.

Ms. Toller highlighted that the COVID-19 pandemic provided an opportunity to test many of the agile measures envisioned as part of the longer-term modernization agenda, such as the use of terms and conditions on authorizations and leveraging the use of foreign decisions where appropriate. Ms. Toller confirmed that Health Canada will build on the lessons learned from COVID-19 as work continues in the advancement of our Regulatory Innovation Agenda, through:

• Modernizing clinical trial regulations
• Enabling advanced therapeutic products
• Enhancing agile licensing for drugs
• Enhancing agile licensing for medical devices
• Establishing a mobile strategy to better communicate to Canadians

Following the presentation, Ms. Toller moderated a panel discussion on Health Canada's regulatory response to the COVID-19 pandemic. Panelists shared their insights and perspectives on the challenges of responding to the pandemic, their experience regulating with more agility and opportunities for further modernization.

Six panelists shared their perspectives:

• David K. Lee, Chief Regulatory Officer, Health Canada
• Dr. Supriya Sharma, Chief Medical Advisor, Health Canada
• David Boudreau, Director General, Medical Devices Directorate
• Robin Churchill, Director General (acting), Natural and Non-Prescription Health Products Directorate
• Dr. John Patrick Stewart, Director General, Therapeutic Products Directorate
• Dr. Megan Bettle, Director General, COVID-19 Regulatory Response Team

Panelists discussed a variety of issues, such as:

• The challenges faced early on in the pandemic, such as the high demand for testing devices and PPE, the unprecedented volume of work, and how temporary agile measures helped speed up the review of needed devices without compromising safety.
• How Health Canada collaborated with stakeholders to re-stock empty shelves with sanitizers and disinfectants through interim policy measures that helped expedite the review process, and by providing timely guidance to companies, particularly those that re-tooled their businesses to support COVID-19 efforts.
• How the response to COVID-19 has helped to test agilities that are a part of Health Canada's regulatory innovation agenda, such as terms and conditions. Within the clinical trial space it was noted that many of the temporary COVID-19 measures are those envisioned for broader modernization, which are needed to adapt to more complex and innovative clinical trial designs.
• The global effort to unprecedented develop safe and effective vaccines for the prevention of COVID-19, and Health Canada's efforts to set the right conditions to conduct rigorous scientific reviews of vaccine submissions efficiently and in-real time. Extensive collaboration with the global regulatory community took place to ensure alignment in approaches to regulatory review of vaccines and treatments.

Question and Answer Session

Following the presentation and panel discussion, participants submitted questions via an online platform for response from Health Canada officials.

Participant questions focused on:

• Vaccine authorization
• Key learnings with respect to interim measures
• Implications of COVID therapeutics' exemption from challenging parts of the Patented Medicines Pricing Review Board changes
• Impacts on the regulatory system as a result of shifts in the health product landscape stemming from the pandemic
• Plans with respect to evaluating virtual care
• Health Canada's collaboration with other international regulators

Closing Remarks and Next Steps

Pierre Sabourin, Assistant Deputy Minister, spoke of HPFB's commitment to its core mandate as the regulator of health products. While HPFB will continue to support the fight against COVID-19, the Branch will also continue to maintain service standards for the review of other much-needed drugs and medical devices essential to the health and well-being of Canadians.

Mr. Sabourin reiterated that HPFB will take the opportunity to learn from the experiences throughout the pandemic and use them to inform and improve future regulatory and operational approaches.

He concluded the event by reaffirming HPFB's commitment to continued collaboration and regular engagement with all stakeholders, and to supporting innovation, while continuing to maintain our rigorous safety standards.