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Home > Pharmaceuticals and life sciences > Canada announces its first-ever
national strategy for drugs for rare diseases


CANADA ANNOUNCES ITS FIRST-EVER NATIONAL STRATEGY FOR DRUGS FOR RARE DISEASES

By Sarah Pennington, Paul Jorgensen and Kristin Wall on March 27, 2023 Posted in
Life sciences and healthcare, Pharmaceuticals and life sciences

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.


LINKS:

 * March 22, 2023 News Release and Health Canada Backgrounder

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