Update: Health Canada released the related Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145), effective November 28, 2021, and Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148), effective March 2, 2022 (as reported in this article).
On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide Health Canada with permanent regulatory tools to help prevent or alleviate therapeutic product shortages.
As a response to the COVID-19 pandemic, the Minister of Health (the “Minister”) previously made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and 2021, including the following:
- the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 dated March 1, 2021 (“Interim Order No. 2”), which replaced the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 dated March 30, 2020 (as previously reported here); and
- the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) dated November 27, 2020 (as previously reported here).
The interim orders provided temporary measures to urgently address shortages and will expire one year from the dates they were made. As a result, the Food and Drug Regulations and the Medical Devices Regulations were amended to maintain a number of the powers from the interim orders made to address shortages since March 2020. In addition, a consequential amendment was made to the Certificate of Supplementary Protection Regulations under the Patent Act. The amendments provide for the following:
- exceptional importation and sale frameworks for drugs on the List of Drugs for Exceptional Importation and Sale and medical devices on the List of Medical Devices for Exceptional Importation and Sale;
- sale of biocides and foods for a special dietary purpose imported under Interim Order No. 2;
- mandatory reporting of shortages of medical devices on the List of Medical Devices – Notification of Shortages;
- mechanism for safeguarding the drug supply, which prohibits drug establishment licence holders from selling certain drugs intended for the Canadian market for consumption or use outside of Canada if that sale could cause or exacerbate a shortage in Canada;
- power by the Minister to request information from regulated parties that the Minister may require to assess a drug or medical device shortage;
- extension of flexibilities related to drug establishment licences for drug-based hand sanitizers; and
- amendment of the definition of “authorization for sale” under the Certificate of Supplementary Protection Regulations to exclude a circumstance where an exceptionally imported drug has been permitted for sale under the amended Food and Drug Regulation.
Certain sections of the Regulations relating to the Food and Drug Regulations came into force on August 12, 2021, when the Regulations were registered. Other sections will come into force on the day following the day on which the Interim Order No. 2 or Interim Order Respecting Drug shortages (Safeguarding the Drug Supply) expires, as applicable.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance group.
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.