27 September 2024

A Word from the CEO

A New Chapter for Canada’s Drug Agency

As we look toward the future of healthcare in Canada, recent changes to the newly renamed Canada’s Drug Agency signal a significant shift in how we approach patient access to innovative treatments. Historically, Canadians have faced delays of up to two years or more to access new medicines and vaccines approved by Health Canada through public drug plans. In fact, we rank last in the G7 and 19th out of 20 peer OECD countries in terms of speed to access. These statistics are not just numbers—they represent real impacts on patient lives.

In response, Health Canada has begun testing a new time-limited access scheme, which aims to bring treatments for conditions with persistent high unmet needs to market more quickly, allowing patients access while manufacturers complete the necessary evidence. However, under current regulations, only additional Randomized Controlled Trial (RCT) data will be accepted to meet the requirements for permanent market access.

We believe there is a better way. The future of healthcare should include real-world evidence (RWE) as part of the data generation process. RWE, derived from real patients receiving care in real healthcare settings, offers invaluable insights into how new treatments truly perform. By integrating RWE alongside traditional RCTs, we can provide a more comprehensive understanding of a drug’s long-term benefits, grounded in the everyday realities of Canadian healthcare.

Embracing RWE not only allows for faster access to innovative medicines, but it also ensures that our healthcare system is building a more complete picture of treatment efficacy and safety—one that reflects the diversity of patients and care delivery in Canada.

Together, let’s advocate for an approach that values all forms of evidence and accelerates access to life-changing treatments for Canadians.

Sincerely,

Kostas Trakas

CEO, Exactis Innovation