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Bettina Hamelin

Bettina Hamelin

President
Innovative Medicines Canada
01 April 2025

Innovative Medicines Canada is an industry association representing Canada’s innovative pharmaceutical companies, advocating for policies that promote pharmaceutical innovation, patient access to medicines, and a stable business environment.

Bettina, as the new President of Innovative Medicines Canada, is there anything you would like to transform within the association? 

Innovative Medicines Canada builds on a century-long history of representing the innovative pharmaceutical industry. Over time, the association has evolved, rebranding itself multiple times to better align with industry needs. I have stepped into a role where our scope has already expanded significantly, and I see a major opportunity to continue on this trajectory. Initially, we focused on patented medicines, then expanded in the 1970s to reflect the growing role of research, eventually becoming Rx&D to enhance collaboration between research, government, and healthcare stakeholders.

Today, we are in an era where policies must promote pharmaceutical innovation while ensuring patient access to new medicines within a stable business environment. Given my background as a scientist, I see this as an opportune moment to build an innovation agenda that capitalizes on groundbreaking science. However, Canada’s healthcare system must be prepared to integrate these advancements, which remains a significant challenge. To address this, we must be proactive in shaping policies that support scientific progress and work collaboratively with the government to create an environment where innovation can thrive.

Can you dwell on the challenges that the Canadian healthcare system faces in adopting innovations?

Canada’s healthcare system is not well-equipped to efficiently integrate scientific advancements, particularly not in a timely manner. Change requires eliminating existing practices or reallocating resources, as healthcare budgets are not limitless. Additionally, we are moving away from a traditional “pill-based” model of small-molecule treatments to more personalized approaches, including gene and cell therapies. These require specialized clinics and infrastructure that Canada currently lacks.

Another major challenge is Canada’s lengthy, sequential regulatory system. The process begins with Health Canada’s approval of a new treatment for safety and efficacy. This is followed by economic analyses by Canada’s Drug Agency, after which the Pan-Canadian Pharmaceutical Alliance negotiates pricing on behalf of all provinces, followed by additional negotiations at the provincial level. This prolonged approval process hinders patient access and delays the adoption of new therapies, making it difficult for Canada to keep pace with innovation.

The FDA is often the first regulator to receive applications from manufacturers and has established itself as a global trailblazer in regulatory approval. The European Union is also highly effective. By contrast, Canada is not typically a first mover, and our approval process significantly extends the time required for new medicines to reach patients.

From the moment a medicine is globally launched to its listing on a public formulary in Canada, the average timeline is three and a half years. By comparison, in the United States, once a medicine is approved, it is immediately launched and available to patients. This delay in Canada creates a significant disadvantage in accessing life-saving treatments.

How would you like to see Health Canada operating?

We would like Health Canada to be more adaptable, flexible, and efficient. One potential solution is recognizing approvals from trusted regulators, such as the FDA or the European Medicines Agency, without requiring an entirely new review process. This concept of regulatory reciprocity would allow jurisdictions to collaborate and accelerate patient access to medicines.

If we consider the current timeline, three and a half years is an unacceptably long wait for Canadians who need these treatments. A more streamlined approach that aligns with international best practices would enhance efficiency and ensure Canadian patients benefit from medical advancements without unnecessary delays.

Canada has the ambition to position itself as a major hub for life sciences. What indicates that Canada is capable of achieving this?

Canada has many advantages that make it an attractive destination for life sciences investment. We have one of the most educated workforces in the world, with highly skilled professionals in life sciences. Our academic institutions and research hospitals are world-class, and Canada ranks sixth globally for the number of highly cited researchers. What is remarkable is that we achieve this despite ranking second-to-last among G7 nations in gross domestic expenditure on R&D.

Ontario, for instance, is a growing hub, with AstraZeneca recently announcing an $820 million investment in an R&D hub in Toronto, creating 700 new jobs. British Columbia is also a strong player, home to companies like Acuitas Therapeutics, which developed the lipid nanoparticles used in Moderna and Pfizer’s mRNA vaccines. AI-driven drug discovery is another area where Canada excels, with companies like Accelera in BC partnering with Eli Lilly. These examples demonstrate the immense potential within Canada’s life sciences ecosystem.

This sends a strong signal about Canada’s potential as a global player in innovation. Companies recognize the scientific talent and investment opportunities available here. If Canada continues to position itself as an attractive destination, we can further solidify our role as a leader in life sciences and pharmaceutical R&D.

What other initiatives is Innovative Medicines Canada working on?

One of our primary initiatives over the last nine months has been accelerating access to medicines. We have developed a proposal based on international best practices and adapted it for Canada. This proposal has already gained traction, with the Premier of Ontario, who chairs the Council of the Federation, committing to prioritizing faster access to medicines. As a first step, Ontario is focusing on accelerating access to oncology drugs, setting a precedent for broader implementation across other therapeutic areas.

Another major focus is Canada’s national pharmacare model. While the goal of providing all Canadians with access to medicines is commendable, the proposed federal model emphasizes cost containment over fostering innovation. We are working closely with governments to design a pharmacare system that balances affordability with access to cutting-edge treatments. Additionally, we engage with regulatory bodies such as Health Technology Assessment agencies and the Pan-Canadian Pharmaceutical Alliance to improve efficiency and ensure patients receive timely access to necessary medications.

Finally, where do you hope to see Canada’s life sciences sector in the coming years?

I want Canada to recognize this as a pivotal moment for science, innovation, and disease treatment. By leveraging our strengths and fostering effective partnerships, we can build a healthcare system that is not only capable of adopting today’s medical breakthroughs but is also prepared for future innovations.

Life sciences partnerships can transcend borders, and Canada has much to offer to the world. By embracing collaboration, investing in infrastructure, and streamlining regulatory processes, we can solidify Canada’s role as a leader in the global life sciences landscape.