Today, the Government announced a total investment of up to $1.5 billion over three years in support of the first-ever National Strategy for Drugs for Rare Diseases to help increase access to, and affordability of, promising and effective drugs for rare diseases to improve the health of patients across Canada.
As part of this overall investment, the Government of Canada will make available up to $1.4 billion over three years to provinces and territories through bilateral agreements. This funding will help provinces and territories improve access to new and emerging drugs for Canadians with rare diseases, as well as support enhanced access to existing drugs, early diagnosis and screening for rare diseases. This will help ensure patients with rare diseases, including children, have access to treatments as early as possible, for better quality of life. As a critical next step to advance the development of these bilateral agreements, the Government of Canada will engage with provinces and territories to jointly determine a small set of new and emerging drugs that would be cost-shared and covered in a consistent way across the country, for the benefit of patients. Similarly, the Government is providing $33 million over three years to Indigenous Services Canada's Non-Insured Health Benefits Program to support eligible First Nations and Inuit patients with rare diseases.
On top of that, the federal government is also investing $68 million for various initiatives to support collaborative governance, data infrastructure, and research for drugs for rare diseases, which will help improve consistency of access to drugs for rare diseases across the country.
These investments correspond to the four pillars that emerged from Health Canada's national consultations, which were:
- Seek national consistency in coverage for drugs for rare diseases: The federal government will provide funding of up to $1.4 billion over three years to provinces and territories via bilateral funding agreements and $33 million over three years to the Non-Insured Health Benefits Program, delivered by Indigenous Services Canada, to deliver results for people living with rare diseases in alignment with the Strategy's vision. This approach will cost-share the coverage of an agreed upon, common, small set of new and emerging drugs for rare diseases, while also enabling provinces and territories to enhance coverage for existing drugs, and supporting improvements in screening and diagnostics, so patients with a rare disease have a better chance of getting access to effective treatments at the right time.
- Support patient outcomes and system sustainability: Investments of $16 million over three years will support the establishment of national governance structures, such as a Health Canada secretariat and a stakeholder Implementation Advisory Group. The Health Canada secretariat will support the coordinated implementation of the Strategy, including supporting the governance to advance collaborative efforts with provinces and territories, as well as with other partners. The Advisory Group, to be struck by Summer 2023, will be comprised of representatives of public and private drug plans, patients and clinicians, the pharmaceutical industry and others. The Advisory Group will provide advice on the implementation of various aspects of the strategy, as well as support continued engagement and information exchange with partners and stakeholders.
- Collect and use evidence: The federal government will provide $20 million over three years to the Canadian Agency for Drugs and Technologies in Health and the Canadian Institute for Health Information to improve the collection and use of real-world evidence to support decision-making, as well as patient registries. This improved information about the safety and effectiveness of drugs for rare diseases will support decision-makers and clinicians, which will in turn benefit patients.
- Invest in innovation: Funding of $32 million over five years to the Canadian Institutes of Health Research to advance research in rare disease with a focus on developing better diagnostic tools, methods for tracking of rare diseases, and establishing a robust Canadian rare disease clinical trials network.
