Health Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the Government of Canada's commitment to create a national strategy for drugs for rare diseases based on recommendations made by the Advisory Council on the Implementation of National Pharmacare.
The "What We Heard Report" is organized around four major themes that were identified in Health Canada's discussion paper and addressed in the consultation feedback. Health Canada's report observes, inter alia:
- Ensure consistent access. Provincial and territorial formularies can have different criteria for making drug reimbursement decisions. A single national framework for rare disease treatments would make access more consistent, but should not remove existing access and must allow for greater say from patients and physicians.
- Expand the evidence-base for drug approvals. Because of the small numbers of people with rare diseases, participants said these drugs need to be assessed differently than drugs for common diseases. Patients and their caregivers should be involved in defining what constitutes a "benefit" or "improvement" when considering treatment outcomes. Novel approaches to help manage access and improve the evidence base should be explored, such as fast-tracking Canadian approval of drugs already approved in other countries, using both international and Canadian data, and joining international evidence-sharing networks.
- Balance spending throughout the health system. Participants indicated that the emphasis on drug costs overlooked their value for patients, the health system, and society as a whole. A variety of ideas were proposed, e.g., emphasising cost-sharing, risk-pooling, collaboration, and attracting clinical trials.
- Focus on the needs of Indigenous communities. Participants indicated that it is necessary to build trust, address differences of experience and racism in the health system, and increase transparency. Indigenous Canadians experience a significant burden of illness and poorer health outcomes than non-Indigenous Canadians. These groups need to be at the decision-making table to help improve health outcomes and coordinate with Indigenous health programs.
Further public consultation to inform a comprehensive model for the national strategy is expected to take place in Fall 2021, with a launch of the national strategy expected in 2022.
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