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14 November 2018
Drug shortages are an important issue in the healthcare system that Health Canada and the industry have been actively trying to address. On 27 August 2018 the minister of health made an order permitting the immediate import 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order was approved on 4 September 2018 and will remain in effect until one year after the order was made, the order is repealed or any regulations that address the need come into effect, whichever is the earliest.
The interim order permits the import of a Food and Drug Administration-approved AUVI-Q, manufactured by Kaléo Inc, which has not been approved in Canada. This is the first time that 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 import 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, and the Special Access Programme.(1)
EpiPen products are reimbursed under certain public drug programmes, including Ontario's recent OHIP+ programme, 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+ programme so the extent to which the interim order will sufficiently address the shortage is unclear, even if AUVI-Q is available in Canada.
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) "Health Canada News" (July 2017), available here
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