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:

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:

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:

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:

Panelists discussed a variety of issues, such as:

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:

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.

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