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Drug shortages are an important issue in the health care system
that Health Canada and the industry have been
actively trying to address. On August 27, 2018, the Minister
of Health made an order permitting the immediate importation and
sale of epinephrine auto-injectors for use in emergency treatment
of life-threatening allergic reactions, to address the shortage of
EpiPen products. The order was approved on September 4, 2018, and will remain
in effect until the earliest of one year after the order was made,
repealed, or any regulations that address the need come into
effect.
The interim order permits the importation of FDA-approved
AUVI-Q, manufactured by Kaléo Inc., which
has not been approved in Canada. This is the first time an interim
order under section 30.1(2)(a) of the Food and Drugs Act
has been used to address the shortage of an approved product.
Interim orders, which can be made if the Minister believes
immediate action is required to deal with a significant risk to
health, safety or the environment, are one of several mechanisms
available to provide access to products that have not been approved
in Canada. Other mechanisms include: the importation of a drug on
the List of Drugs for an Urgent Public Health Need
enacted under Part C, Division 10 of the Food and Drug
Regulations (as
previously reported), and the Special Access Programme.
EpiPen products are reimbursed under certain public drug
programs, including Ontario's recent OHIP+ program, which
provides drugs for free to those in Ontario 24 years of age and
under. AUVI-Q does not appear to be covered under the OHIP+ program
so it is unclear the extent to which the Interim order will
sufficiently address the shortage, even if AUVI-Q is available in
Canada.
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.
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