Question Period Note: Status of Domestic Biomanufacturing Capacity

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• Canada is implementing the Biomanufacturing and Life Sciences Strategy, which aims to grow a strong, competitive, and resilient domestic life sciences ecosystem, with cutting-edge biomanufacturing capabilities, and to ensure Canada is prepared for future pandemics and health priorities.
• The Strategy’s funding opportunities are underway through the Strategic Innovation Fund, the integrated Canada Biomedical Research Fund/Bioscience Research Infrastructure Fund, and the Clinical Trials Fund, which intend to stimulate growth and innovation and strengthen talent in Canada’s life sciences and biomanufacturing ecosystem.
KEY MESSAGES
• The government continues to work to position Canada to develop and produce safe and effective vaccines and therapies that respond to COVID-19.
• Canada is investing to establish world-class end-to-end domestic biomanufacturing capacity – from research and development to fill and finish.
• Canada’s Biomanufacturing and Life Science Strategy is focusing on growing our domestic life science ecosystem to prepare Canada for future pandemics and other health priorities.
• Budget 2021 provided $2.2 billion over seven years towards growing a vibrant domestic biomanufacturing and life sciences sector.
IF PRESSED ON THE DOMESTIC CAPACITY TO DEVELOP MRNA VACCINES…
• To date, mRNA vaccines have proven to be highly effective in preventing severe disease, and they represent an alternative to traditional vaccines, with potential for rapid development and scaling of production.
• Canada is prioritizing mRNA technology for the important and innovative role it is anticipated to play in future vaccine development and preparedness for future pandemics, outside of the COVID-19 context.
• This includes partnerships with leading mRNA vaccine developers like Moderna who is building a state-of-the-art mRNA vaccine manufacturing facility in Quebec.
IF PRESSED ON THE MODERNA FACILITY…
• Moderna is a leading mRNA vaccine developer that has demonstrated, through its response to the COVID-19 pandemic, its benefit as a flexible solution to unanticipated health events.
• In 2022, the Government of Canada and Moderna announced that Moderna is building a state-of-the-art mRNA vaccine manufacturing facility in Quebec. When completed, it will produce up to 100 million pandemic vaccine doses annually.
• Moderna’s new facility will not only strengthen Canada’s preparedness for future pandemics but will also help position Canada as an mRNA centre of excellence.
IF PRESSED ON MITSUBISHI TANABE PHARMA CORPORATION’S DECISION TO CEASE OPERATIONS AT MEDICAGO INC. …
• Our Government was disappointed to learn of Mitsubishi’s recent decision to begin the process to wind-down its support for Medicago’s operations.
• Medicago remains the only Canadian-based company to have received market authorization by Health Canada for its COVID-19 vaccine. Its innovative, plant-based vaccine platform technology remains highly regarded by experts.
• Canadians can be assured that we are in contact with both Medicago and Mitsubishi to ensure an orderly transition process, and make sure Canadian interests are protected.
• Protecting the health and safety of Canadians is our government’s top priority, including ensuring we have sufficient domestic vaccine production capacity to protect against future infectious disease threats and pandemics.
IF PRESSED ON VACCINE INVESTMENTS …
• Canada is working to re-establish domestic capacity across key vaccine platforms, to be better prepared for future health emergencies.
• This includes the National Research Council’s new Biologics Manufacturing Centre in Montreal, which has partnered with Novavax to produce its COVID-19 vaccine, and investments in companies like Biovectra and Sanofi Pasteur.
• It also includes partnering with Moderna, who is building a state-of-the-art mRNA vaccine manufacturing facility in Quebec, and significant investment to Sanofi Pasteur who is establishing an influenza vaccine manufacturing facility in Ontario.
IF PRESSED ON PANDEMIC VACCINE PREPAREDNESS …
• The COVID-19 pandemic has reinforced the importance of strengthening domestic capacity to rapidly develop vaccines to protect all people in Canada against pandemics and other health emergencies.
• Through strategic investments and partnerships, the Government of Canada is working to grow Canada’s domestic life sciences sector and biomanufacturing capacity. These include those with Moderna who is in the process of building a state-of-the-art mRNA vaccine production facility in Quebec, and Sanofi Pasteur who is establishing an influenza vaccine manufacturing facility in Ontario.
IF PRESSED ON THE VACCINE TASK FORCE AND COUNCIL OF EXPERT ADVISORS…
• We thank the COVID-19 Vaccine Task Force for their critical role in advising on the Government of Canada’s COVID-19 vaccine response efforts.
• As the scope of the Task Force’s work has expanded, the Council of Expert Advisors was established to transition from the Vaccine Task Force and assume a long-term advisory function.
• The expertise on the Council of Expert Advisors is broad – advising on scientific, health, public health, and industrial matters –supporting the Government’s goal of a revitalized Canadian life-science sector and improved pandemic preparedness.

Biomanufacturing and Life Science Strategy

At the outset of the COVID-19 pandemic, the Government of Canada took early and decisive action to strengthen Canada’s biomanufacturing capacity to protect Canadians, and to provide investment to support domestic biomanufacturing capabilities. A key element is the implementation of the Biomanufacturing and Life Sciences Strategy (the Strategy) announced in June 2021.

Ministers of Health and Innovation, Science, and Industry have joint accountability for the Strategy which outlines actions to take a coordinated approach to grow Canada’s domestic capacity to rapidly develop and produce vaccines, therapeutics and other lifesaving medicines to improve readiness for future pandemics or other health emergencies and sector growth. This included Budget 2021 investments of $2.2B.

The five pillars of the Strategy are:
• Coordinating Governance;
• Strengthening Research Systems and the Talent Pipeline;
• Growing Canada’s Life Sciences and Biomanufacturing Sector;
• Operationalizing National Research Council’s Biologics Manufacturing Centre (BMC) and Considering a National Centre; and,
• Ensuring Best-in-Class Regulation & World-Class Clinical Trials Systems.

Increasing domestic capacity and building a robust life sciences sector will require dedicated efforts to connect and mobilize federal investments and assets in collaboration with academia and industry to the broader life sciences ecosystem.

The emergency regulatory measures put in place during COVID-19 aim to make the system more agile, and enable prompt access within Canada to health products needed to diagnose, treat and slow the spread of the virus without compromising safety, efficacy and quality. Going forward, it will be important to maintain this level of agility (especially during non-pandemic times) to ensure Canadians receive access to needed health products. Efforts are underway to modernize regulations in areas such as agile licensing for drugs and medical devices, clinical trials, and advanced therapeutics.

The COVID-19 Vaccine Task Force and Council of Expert Advisors (CEA)

One of the main focuses on the Biomanufacturing and Life Sciences Strategy is establishing dedicated governance to ensure the Government’s actions across the entire life sciences ecosystem are coordinated and expertly guided to ensure alignment and the achievement of the Strategy’s objectives.

While the COVID-19 Therapeutics Task Force and the COVID-19 Vaccine Task Force were formed at the onset of the pandemic and played a foundational role in, providing invaluable insights and scientific validation in Government of Canada’s pandemic response tactics, the Task Forces were not established to be permanent. As the scope of pandemic response efforts shift towards more enduring operational structures, Canada requires a permanent advisory body with broader expertise to provide guidance during pandemic and interpandemic settings. The Council of Expert Advisors (CEA) was established to take on this longer-term role.

The CEA brings together leading experts across biomanufacturing and life sciences to advise the Government on overall strategic priorities, specific project proposals, funding opportunities and other proposed actions. The CEA will also monitor progress on the Strategy’s initiatives and advise on ways to adapt approaches and strategies to respond to new technologies and changing conditions in the marketplace.

Investments under the Biomanufacturing and Life Sciences Strategy

Budget 2021 committed $1B over seven years through the Strategic Innovation Fund to support life science firms to innovate and expand in Canada. Thus far, one (1) project, Biovectra in Charlottetown, Prince Edward Island, has been funded while the remaining projects are moving through the evaluation process.

Supported through Budget 2021 commitments, the Government of Canada has launched two (2) funds to help strengthen Canada’s talent pipeline and research systems, including the Canada Biomedical Research Fund ($250M over four years) which supports transitional and applied research, training and talent development, to drive downstream manufacturing capacity, and the Bioscience Research Infrastructure Fund ($500M over seven years), which will support the bioscience capital and infrastructure needs of post-secondary institutions and research hospitals.
• These funds are administered through Canada’s three federal research agencies, the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada along with the Canadian Foundation for Innovation (CFI).

The first of these investments has been made by CFI in November 2022, with $127 million distributed through the Bioscience Research Infrastructure Fund. This investment responds to urgent and essential needs of postsecondary institutions and research hospitals by supporting biocontainment facilities capable of working with pathogens.

The Canadian Institutes of Health Research has launched three funding opportunities under the Clinical Trials Fund (pan-Canadian clinical trials consortium, clinical trials training platforms, clinical trials projects) in May 2022 and are under peer review, with funding set to begin this Fall.

Canadian Biomanufacturing Capacity Since 2020

In addition to Budget 2021 funding, the government has announced a number of investments to bolster domestic production capacity through the Strategic Innovation Fund, Next Generation Manufacturing Canada Supercluster, the National Research Council, Regional Development Agencies, and other government partners, including in:
• National Research Council (NRC) (Montréal, QC) - $126 million to establish the new Biologics Manufacturing Centre;
• Medicago (Quebec City, QC) - $173 million to develop a plant-based virus-like-particle vaccine and for the construction of a Good Manufacturing Practice facility.
• AbCellera (Vancouver, BC) - $175.6 million in government support of antibody discovery for clinical testing and for the construction of a GMP antibody production facility;
• Vaccine and Infectious Disease Organization (VIDO) (Saskatoon, SK) – $59.2M, over three years, starting in 2021-22, to support the development of its vaccine candidates and expand its Saskatoon facility;
• Precision Nanosystems (Vancouver, BC) - $25.1 million in government support to build a biomanufacturing centre for production of RNA vaccines;
• KABS Laboratories (St-Hubert and Val des Sources, QC) - $54.25 million toward a biologics production facility with a focus on antibody therapies and new fill-finish capabilities;
• Novocol (Cambridge, ON) - $32.7 million contribution for expanded fill-finish capacity;
• Providence Therapeutics and Northern RNA Inc. - $5 million through the Next Generation Manufacturing Supercluster to expand their operations in Calgary to design and manufacture COVID-19 vaccines and build a pipeline of mRNA vaccines;
• Sanofi Pasteur (Toronto campus) – up to $415 million support towards building an end-to-end influenza vaccine manufacturing facility; and,
• Resilience Biotechnologies (Mississauga, ON) - $199 million to increase manufacturing and fill/finish capacity for a number of vaccines and therapeutics including mRNA technologies.

Moderna’s Canadian Facility

In 2022, the Government of Canada and Moderna announced that Moderna would build a state-of-the-art mRNA vaccine manufacturing facility in Quebec. Construction of the facility is underway, and when completed, will be able to produce up to 30 million mRNA vaccine doses per year in non-pandemic times and up to 100 million doses per year during a pandemic.

Moderna is a leading mRNA vaccine developer that has demonstrated, through its response to the COVID-19 pandemic, its benefit as a flexible solution to unanticipated health events—not only by rapidly developing a successful COVID-19 vaccine, but also by producing and distributing it at commercial scale. Having an mRNA developer producing vaccines at scale in Canada represents one important piece in Canada’s plan to rebuild the life sciences sector and will better protect Canadians for whatever the future holds.

Moderna’s new facility in Canada will not only help strengthen our biomanufacturing sector and pandemic preparedness but will also help position Canada as an mRNA centre of excellence and a global mRNA research and development (R&D) hub. As part of the agreement with the Government of Canada, Moderna is committed to building a robust R&D Workplan, which will include Pandemic Preparedness R&D projects along with development of partnerships with Canada’s leading research universities and institutions to help advance research and development here at home. For example, Moderna has already partnered with McGill University through Moderna’s mRNA Access program to accelerate vaccine innovation, as well as with the University of Toronto to do research across a range of scientific disciplines to develop new ways to treat infectious diseases.

The facility will boost the Canadian economy through the creation of hundreds of jobs during construction and operation of the facility, including direct and indirect biomanufacturing and research jobs. Moderna’s facility will also mean domestic opportunities for the brightest young minds in the field through internships, co-op positions, and other Moderna-supported training and development opportunities. In this way, the facility will enhance Canada’s talent pipeline by attracting, developing and retaining a highly skilled workforce. The facility will also offer the potential for Canadian companies to work with Moderna, and, where possible, opportunities to comprise part of Moderna’s supply chain.

In November 2022, Prime Minister Justin Trudeau Participated in the facility’s ground-breaking ceremony. The facility is expected to be operational in 2024 at the earliest, subject to planning and regulatory approvals. In addition to COVID-19 vaccines, the facility is expected to be able to produce vaccines for other respiratory diseases, such as influenza – pending their ongoing development by Moderna and approval by Health Canada.

Medicago

Medicago is the only Canadian-based company to have received market authorization for Covifenz COVID-19 vaccine. Covifenz is the product of years of scientific efforts that began with public science collaboration between Agriculture and Agri-Food Canada and the Université Laval in the late 1990s. Since then, Medicago has established itself as an innovative global leader in plant-based vaccines, using living plants as bioreactors for the production of virus-like particles (VLP).

In 2020, Canada entered into an advance purchase agreement (APA) with Medicago to secure access to up to 76 million doses of its COVID-19 vaccine (20M firm doses and 56M optional doses). Due to unanticipated manufacturing issues, Medicago has not marketed any lots of its COVID-19 vaccine for commercial use.

On February 3, 2023, Mitsubishi Tanabe Pharma Corporation announced that it has decided to cease all operations with Medicago Inc. That same day Health Canada’s Health Products and Food Branch were informed that Mitsubishi Tanabe will be cancelling their vaccine authorization and withdrawing the submission currently under review (which would had been filed to extend the use of the vaccine to the elderly population). Health Canada will work with Medicago to close out their files.

Medicago, whose headquarters is in Quebec City and operates an additional facility in North Carolina, employs roughly 550 people (about 400 in Canada). The company has been 100% owned by Mitsubishi Tanabe Pharma since December 2022. Before the decision, global tobacco giant Philip Morris International owned 21 per cent of the company's shares. Medicago’s plant-based COVID-19 vaccine, Covifenz, was initially rejected by the World Health Organization over its ties with the tobacco industry.

Inspection and Licensing – Oversight of Drug Manufacturing in Canada

Health Canada’s role in regulating drugs is to evaluate and approve products, set requirements, monitor safety and enforce compliance and communicate health risks. Further, Health Canada approves establishments involved in the manufacturing of drugs marketed for use in Canada.

To ensure drugs are safe, effective and of high quality, all drug producing facilities in Canada, including those supporting domestic biomanufacturing efforts, must hold a Drug Establishment License and be inspected by Health Canada to demonstrate it meets Good Manufacturing Practices, known as “GMPs”.

Health Canada continues to remain supportive in strengthening Canada’s drug manufacturing capacity and prioritizing new and continued COVID-19 drug manufacturing, enabling industry with responsive and flexible regulations to mobilize and support current needs of the domestic market.

Health Canada is committed in providing regulatory advice and guidance in the planning and development of operations to support domestic biomanufacturing in Canada now and into the future.

As part of Health Canada’s role in ensuring a safe and effective drug supply, inspection and other regulatory experts will continue to promote and enforce Canada’s high standards for drug manufacturing.

• Canada announced the creation of the Biomanufacturing and Life Sciences Strategy on July 28, 2021, to re-build a strong and resilient domestic biomanufacturing and life sciences sector.
- Investments in biomanufacturing capacity can reduce our reliance on imported products and strengthen our domestic industrial capacity.
- The Government will work with provinces, territories, and other partners to deliver real results for Canadians.
- The strategy is supported by existing resources and Budget 2021 investments, including support of $2.2 billion for the revitalization of Canada’s biomanufacturing and life science sector.
- Health Portfolio explicit work includes:
 $250 million, over three years, for the Canadian Institutes of Health Research to establish a new Clinical Trials Fund.
 Advancing regulatory modernization efforts, including: modernized clinical trial regulations, a new pathway for advanced therapeutic products; agile regulations for the licensing of drugs and medical devices
• The objective of the Biomanufacturing and Life Sciences Strategy is to grow the domestic life sciences ecosystem and prepare Canada for future pandemics and health priorities. In order to improve Canada’s pandemic vaccine preparedness, the Biomanufacturing and Life Sciences Strategy proposes increasing domestic biomanufacturing capacity across multiple platforms, including those that represent the latest in vaccine technology, such as mRNA.