E-drug: Compassionate use? (cont)
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I don't know the US system for compassionate use, but can explain the
Canadian system. It used to be called compassionate use and is now
called a special authority procedure. A doctor can request a drug
that is not approved in Canada for a specific patient under a
'special authority'. The doctor sends the request to the federal
ministry of health, which then decides whether to authorize the
company involved to sell the drug to this specific patient.
Each case is decided on its individual merit. The aim is to make
experimental drugs available quickly to patients for which no
adequate treatment is currently available, especially with
life-threatening diseases. There are no restrictions on which drugs
may be requested. The company does not need to be in the process of
applying for approval in Canada and the drug does not need to have
'investigational new drug' status (approval for use in clinical
trials).
I attended a training session on the national drug approval process by an
industry consultant who said that there were currently 18,000 such
special authorities granted per year in Canada. (population around 30
million) She also mentioned examples of requests for a sleeping pill
not approved in Canada, and many special authorities for sildenafil
(Viagra) before it was approved.
Barbara Mintzes
Centre for Health Services & Policy Research, UBC
Vancouver, Canada
bjmintzes@cs.com
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