On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability.
Investments made as part of the National Strategy
The lion’s share of the federal government’s investment – up to $1.4 billion – will be made available to the provinces and territories through bilateral agreements. This funding is intended to improve access to new and emerging drugs for rare diseases and to support enhanced access to existing drugs, screening, and early diagnosis. Of note, the federal government intends to engage with the provinces and territories to jointly determine a small set of new and emerging drugs that will be cost-shared and covered in a consistent way across the country.
Investments made as part of the National Strategy will also include:
- $33 million for Indigenous Services Canada’s Non-Insured Health Benefits Program;
- $16 million to establish national governance structures, such as a Health Canada secretariat and a stakeholder Implementation Advisory Group;
- $20 million for 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; and
- $32 million to the Canadian Institutes of Health Research to advance research in rare diseases, with a focus on developing better diagnostic tools, as well as a rare disease clinical trials network.
Four pillars of the National Strategy
According to Health Canada, the investments made in the National Strategy correspond to four pillars that emerged during its national consultations (previously reported on here):
- seek national consistency in coverage for drugs for rare diseases;
- support patient outcomes and system sustainability;
- collect and use evidence; and
- invest in innovation.
No special market exclusivity rights
Canada’s rare disease strategy does not address any intellectual property or market exclusivity rights targeted to encourage access for rare disease drugs. In the U.S., new treatments for rare disease can be designated an “orphan product” eligible for a seven year period of market exclusivity after approval. The EU also provides a ten year term of market exclusivity for designated orphan drug products.