Proposed PMPRB regulations require focused dialogue with all players

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Canada needs an approach that balances pricing considerations with the need to encourage investment, foster innovation, and most of all, ensures Canadians have timely access to the most innovative, life-saving new medicines.

Pamela Fralic, President, Innovative Medicines Canada

This article originally appeared in The Hill Times on February 17, 2022.

In December [2021], the federal government formally announced it was delaying the implementation of the Patented Medicine Prices Review Board (PMPRB)’s regulatory changes. There were two reasons stated for the delay. First, it would allow all parties—including the government and the pharmaceutical industry—to focus on the real priority, namely the ongoing fight to contain the spread of COVID-19 in the face of new and challenging variants. Second, in announcing it, the federal Minister of Health Jean-Yves Duclos made clear that the time afforded by the delay would be used to “consider and continue to discuss the amending regulations” with stakeholders.

Speaking on behalf of Canada’s innovative medicines industry, I can say that we welcomed this delay for the very reasons stated by the minister. But meaningful dialogue takes time, and unfortunately, as we enter the second month of a six-month delay, time is a limited commodity. And every day that passes without ongoing, sustained engagement is a lost opportunity for patient groups, government, industry, and other stakeholders to work together to develop a meaningful regulatory approach. Canada needs an approach that balances pricing considerations with the need to encourage investment, foster innovation, and most of all, ensures Canadians have timely access to the most innovative, life-saving new medicines.

The pandemic has shown us not just the critical role of a strong life sciences sector in Canada, but also that tremendous innovation is possible when all parts of the ecosystem work together. For instance, in roughly 15 months, we developed, together, vaccines and boosters needed to protect us from the worst of COVID-19. An astonishing feat given that under normal circumstances developing vaccines can take anywhere from 10 to 15 years, at a cost of billions of dollars. And one that is due in large part to the effective collaboration between the public and private sectors.

We have a unique opportunity to sustain that spirit of partnership and innovation for the benefit of all Canadians, but it requires a willingness to engage one another, and acknowledge the vital contributions of all partners in the life sciences sector. No one party can drive the discovery, development, and delivery of life-saving medications or treatments to combat, for example, unplanned public health challenges like COVID-19, secondary health impacts from the pandemic or emerging impacts from antimicrobial resistance. Simply put, private sector companies, like our members, are an integral part of the life sciences ecosystem and should be viewed as a value-creating economic and health partner—not simply a cost to be managed.

In addition to the innovative medicines and vaccines we help to develop and deliver to improve the health and well-being of Canadians, our industry contributes in other critical ways. The Jan. 28 Statistics Canada sector report highlights the contribution that the innovative medicines industry makes. From supporting over 100,000 high-value jobs and adding $15 billion in economic activity to the Canadian economy, to increased R&D spending on in-house investments and external agreements with universities and hospitals, the sector is a significant economic growth engine in Canada. Based on Statistics Canada data, the innovative pharmaceutical sector’s R&D to sales ratio is 9.7 per cent, up from 8.8 per cent from the previous year.

If government, industry, patient groups, and other stakeholders work together, there are several things we can do to maintain that economic contribution and ensure that Canadians continue to have access to clinical trials and innovative new medicines. This includes taking steps to encourage private-sector investment in Canada. It is that investment which helps to fuel the innovation that protects or increases Canadians’ access to clinical trials and to new medicines. It also creates the jobs, partnerships, and other economic benefits described above.

Solutions to complex challenges take time. We need to work together to build a regulatory approach that is internationally competitive, protects intellectual property, that is harmonized with provincial and territorial needs and life sciences strategies and takes a whole-of-government approach to policy-making.

I am convinced that by working together we can develop solutions that allow the government to meet its policy objectives, help rebuild our economy, strengthen Canadian biomanufacturing, and grow our life sciences sector. But it will require a sustained and focused dialogue, with all parties at the table. Canada’s innovative medicines industry, for one, remains ready to play our part to improve the lives of Canadians and looks to the government to pull up a chair.


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