Vincent M. de Grandpré, Jaymie Maddox
Apr 21, 2020
For further information on the changes below or other intellectual property matters, please contact one of the authors above or any member of our Intellectual Property or Intellectual Property Litigation Groups.
As the COVID-19 pandemic continues to challenge the Canadian healthcare system, concerns have been raised about potential shortages of necessary drugs and medical supplies. To address this situation, the Canadian government has adopted an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order), which relaxes regulatory requirements to facilitate the importation into Canada of drugs and other products in serious short supply. The Interim Order offers an opportunity for manufacturers to answer Canada’s pressing call for required medical supplies and to test the waters of the Canadian market while shortages last.
On March 30, 2020, the Canadian Minister of Health issued the Interim Order under section 30.1(1) of Canada’s Food and Drugs Act. The Interim Order allows importers holding Canadian drug establishment licenses (DELs) to import designated products without meeting all of the requirements of the Canadian Food and Drug Regulations. In particular, importers are exempt from meeting a variety of drug labelling, sampling and release requirements.
The products eligible to be designated under the Interim Order are drug products assessed by the federal government, healthcare and industry stakeholders to be subject to a Tier 3 shortage, meaning a shortage with the greatest potential impact on Canada’s drug supply and healthcare system. Importers may make proposals to Health Canada to have their products on the Tier 3 shortage list added to the List of Drugs for Exceptional Importation and Sale. Health Canada has so far designated over a dozen drugs for exceptional importation and sale, including products originating from the United States, Austria and Sweden.
Importers of designated drugs must hold a DEL that covers the importation of the drugs and dosage forms, in addition to having buildings outside of Canada listed in such licenses (e.g., in a DEL Foreign Building Annex or API annex). Existing controls for prescription drugs, adverse drug reaction and recall reporting, as well as most good manufacturing practice (GMP) requirements under the Food and Drug Regulations are not relaxed under the Interim Order. Health Canada must also be notified by email five calendar days before the designated drug is actually imported.
The Interim Order is particularly beneficial for importers of designated drugs from countries with partnerships and mutual recognition agreements (MRAs) with Canada. For example, Health Canada will consider a foreign building compliant if it is determined to be GMP-compliant by a trusted regulatory partner (e.g., the U.S. FDA) for the applicable activity, category of drug and dosage form. Under the Interim Order, importers of drugs fabricated, packaged, labelled and tested in countries subject to an MRA with Canada, such as the United Kingdom and Australia, also benefit from reduced finished-product testing requirements.
Manufacturers that have not previously distributed a particular drug in Canada may now take advantage of the Interim Order to import and sell that product in Canada. Manufacturers unfamiliar with the Canadian market may also take advantage of the Interim Order, while shortages last, to gain valuable experience with Canadian regulators and commercial players, all the while assisting Canada’s response to the COVID-19 pandemic.