Canada is one of the few developed countries without a specific
regulatory framework for drugs for rare diseases, often termed
"orphan drugs". Over the past few years, the
federal government has been working on revising the Canadian
Food and Drug Regulations to implement a specific pathway
for these drugs. As reported in our earlier
Pharma-in-Brief in October 2012, the government has been taking
steps to implement a regulatory framework, including the
government's review and powers of oversight over this class of
drugs. A key focus of the new approach will be on
international information-sharing and collaboration for the
development and regulation of orphan drugs.
In August 2014, the Minister of Health Rona Ambrose announced a
pilot project targeting patient input from Canadians to help
inform future reviews of orphan drugs. The project will
simulate how input from patients will be gathered and incorporated
into the drug submission review process once the Orphan Drug
Framework is in effect. While the regulatory framework has
yet to be announced and there is no set definition as yet as to
what qualifies as a "rare disease", communications from
the government suggest the definition to be in line with that used
by other jurisdictions, namely, that a rare disease is "a
life-threatening, seriously debilitating, or serious chronic
condition that only affects a very small number of patients
(typically less than 5 in 10,000 persons)."
In a journal article published in February 2014 (J Popul Ther
Clin Pharmacol Vol 21 (1): e42-e46: February 23, 2014) it was
noted that of the 99 drugs with orphan indications approved by the
U.S. Food and Drug Administration (FDA) from 2008 to 2013, as of
May 2013, only 51 of these had been approved (through the regular
submission process) in Canada. Another 21 were approved for
sale in Canada under the special access programme. The
article also explains the intended approach of Health Canada,
noting that regulations will set the criteria for designation,
aligned to the greatest extent possible with those used by the
European Medicines Agency and the FDA, will outline the
requirements for market authorization and will mandate post-market
oversight. Flexibility in the design of trials and evaluation
of results will be allowed to accommodate smaller patient
There is currently no timeline established for introduction of
the new Regulations. However, given that amendments to the
Food and Drugs Act are still before Parliament (in Bill C-17,
an Act to Amend the Food and Drugs Act, introduced on December
6, 2013), which is directed towards patient safety and includes
many broad regulation-making authorities, publication of orphan
drug regulations for comment could well be awaiting passage of that
Bill. In terms of steps to finalization, the Regulations will
need to be first published for comment in Canada Gazette Part I,
with comments received then taken into account for final
publication of the regulations in Canada Gazette Part II.
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