On March 22, 2023, the Minister of Health announced the first-ever National Strategy for Drugs for Rare Diseases (additional background here). This strategy includes $1.5 billion invested to “increase access to, and affordability of, effective drugs for rare diseases to improve the health of patients across Canada, including children.” Funding will be directed as follows:
- Up to $1.4 billion to provinces and territories through bilateral agreements (to be negotiated) to improve and enhance access to drugs, early diagnosis and screening for rare diseases. To begin, the Government of Canada, provinces, and territories will determine a list of new drugs to be cost-shared and covered in a consistent way.
- $33 million over 3 years to Indigenous Services Canada's Non-Insured Health Benefits Program to support eligible First Nations and Inuit patients with rare diseases.
- $20 million over 3 years to the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Canadian Institute for Health Information (CIHI) to improve evidence collection and use.
- $32 million over 5 years to the Canadian Institutes of Health Research (CIHR) to advance research in rare diseases.
- $16 million over 3 years to establish national governance structures.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
Related Publications & Articles
-
Health Canada consultation on revised biosimilar guidance: no requirement for comparative clinical efficacy and safety trials
On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions...Read More -
Update on biosimilars in Canada – June 2025
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access.Read More -
Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training
TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal to overturn the refusal of the Minister of Mental Health and Addictions...Read More