Bringing Medicines and Vaccines to Patients Faster: Regulatory Modernization Improves Access for All 

By Najah Sampson, Pfizer Canada President

October 2, 2023
 

Reflecting on the COVID-19 pandemic, we’ve learned a lot about the interconnectedness of our Canadian health system. An agile and flexible regulatory framework throughout the development, manufacturing, and supply of vaccines was critical to our ability to respond to the urgent public health challenge. All levels of Canadian governments and health care systems worked together to allow for the accelerated and efficient regulatory review and access to new innovative medicines and vaccines to improve the health and wellness of Canadians and save lives. This collaboration and agility at the regulatory level is what enabled Canada to maximize the health and societal benefits of the country’s vaccination programs and COVID-19 treatments.

This is why Pfizer Canada supports Health Canada’s ongoing efforts to modernize the regulatory framework to support the agile licensing of drugs, vaccines, and medical devices in the future. Health Canada’s Regulatory Innovation Agenda will increase its ability to keep pace with medical innovation and will contribute to a more efficient system. 

Working together, we can apply what we learned during the pandemic and help ensure that Canadian patients continue to get fast and equitable access to life-saving medicines and vaccines. 

An Agile Regulatory System

Through out the pandemic, Health Canada put in place emergency temporary legislative, regulatory, and policy measures to facilitate clinical trials and ensure product access in time of crisis. They engaged with international regulatory partners to ensure alignment and collaborated with companies interested in importing and manufacturing products to support Canada’s response.[1]

This response resulted in a more agile regulatory system without compromising safety, efficacy, and quality.[2]

As detailed in Canada’s Biomanufacturing and Life Sciences Strategy, this regulatory response focused on actively collaborating with domestic and international stakeholders and partners. In addition, emergency regulatory pathways and measures were established to prioritize and expedite the processes for regulatory review and establishment licensing that included implementing dedicated teams of multi-disciplinary experts to conduct rolling reviews for vaccines and drugs, where multiple teams work simultaneously and in real time to review information from manufacturers as soon as submitted. Furthermore, post-market surveillance of safety and effectiveness was enhanced as were public communications and transparency activities.[3]

Modernization to Keep Pace with Innovation

Canada already has many key elements in place to support effective health research and therapeutic innovation: a diverse population, a public health system, and a world-class collection of scientific talent and medical expertise. Some of the most important considerations are leveraging Canada’s existing strengths, identifying the key gaps we need to close, creating a world class regulatory regime as stated in Canada’s Biomanufacturing & Life Sciences Strategy, and ultimately being better prepared for the next major healthcare crisis.

The rate of innovation is moving rapidly with the use of Artificial Intelligence (AI), the development of digital health solutions, and the advancement of diagnostic testing. In order to keep pace with such innovations and with other jurisdictions, Health Canada will need to continue to evolve the regulatory framework, guidance, and policies to address innovative advancements and continue to be forward thinking. 

Health Canada is currently undertaking consultations on proposed agile regulations and guidance for licensing drugs and medical devices as part of its modernization agenda. Ensuring the implementation details match the promise and ambition of the policy objectives is key.

Canada should not fall behind other jurisdictions with respect to regulatory innovation and agility. The proposed modernizations should ensure greater harmonization of regulatory requirements with international peer authorities and reduce regulatory burden for Canadian manufacturers. New pathways such as rolling reviews and authorizations with Terms & Conditions must be optimally implemented and aligned with international regulatory peers, avoiding Canada specific requirements as well as increased uncertainty. This will ensure that Canadians can continue to benefit as quickly as possible from future innovations. While regulatory modernization is critical, it is recognized that Health Canada is undertaking these changes with the resources available to them. It is therefore equally critical to ensure an efficient process that leverages global best practices so that Canada can continue to be a destination of choice for research and development as well as early filings for innovative medicines and vaccines.

Timely Access for All 

All levels of government, health agencies, the patient community, and other key stakeholders must work in a coordinated fashion to ensure availability and accessibility of new medicines and vaccines for patients. Less than 1 in 5 new medicines launched globally are available to Canadian patients on public plans and of the medicines that are available, Canadian patients wait twice as long as patients in most peer countries for access following Health Canada approval.[4] To continue efforts aimed at supporting the best possible health outcomes for Canadians, the regulatory framework in Canada must be globally competitive allowing rapid access to innovations and comparable timeliness of integration within the healthcare system. Benefits can only be realized by patients if there is timely access to needed innovations.

Pfizer Canada remains ready to partner with government to ensure timely and equitable access to medicines and vaccines for those who need them most. We support the efforts to modernize our regulatory system to achieve Health Canada’s goals and support the government’s Biomanufacturing and Life Sciences Strategy. Health Canada's Regulatory Innovation Agenda should aim to ensure a regulatory framework that, at a minimum, matches or ideally exceeds that of world-class jurisdictions to ensure the efficient review and authorization of new innovative treatments, vaccines and devices for the benefit of Canadians. 

[1] Canada’s Biomanufacturing and Life Sciences Strategy, Government of Canada, 2021: https://ised-isde.canada.ca/site/biomanufacturing/en/canadas-biomanufacturing-and-life-sciences-strategy 

[2] Drug and medical device highlights 2020: Helping you maintain and improve your health, Government of Canada, 2021: https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020.html 

[3] Canada’s Biomanufacturing and Life Sciences Strategy, Government of Canada, 2021: https://ised-isde.canada.ca/site/biomanufacturing/en/canadas-biomanufacturing-and-life-sciences-strategy

[4] Access to Medicine, Innovative Medicines Canada: https://innovativemedicines.ca/browse-by/access-to-medicine/ 

[1] Canada’s Biomanufacturing and Life Sciences Strategy, Government of Canada, 2021: https://ised-isde.canada.ca/site/biomanufacturing/en/canadas-biomanufacturing-and-life-sciences-strategy 

[2] Drug and medical device highlights 2020: Helping you maintain and improve your health, Government of Canada, 2021: https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020.html 

[3] Canada’s Biomanufacturing and Life Sciences Strategy, Government of Canada, 2021: https://ised-isde.canada.ca/site/biomanufacturing/en/canadas-biomanufacturing-and-life-sciences-strategy

[4] Access to Medicine, Innovative Medicines Canada: https://innovativemedicines.ca/browse-by/access-to-medicine/