Health Canada: Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19
On October 16, 2020, the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 was signed by the Minister of Health and was enforced effective immediately. The purpose of the Interim Order is to address the challenges of drug shortages that have been directly or indirectly impacted by the COVID-19 pandemic, and aim to reduce the impacts of drug shortages by preventing or alleviating a drug shortage. The IO pertains to therapeutic products, which includes prescription and non-prescription drugs and vaccines. This does not include veterinary products or natural health products.
The IO allows the Minister of Health to request information about a drug shortage or a potential shortage, and amend the terms and conditions of the drug in question. A shortage is considered to be related to the pandemic if it is used in the treatment of COVID-19 patients, and/or if its availability is impacted by the pandemic. Authorizing this information will allow Health Canada to act quickly, evaluate the situation at hand, and respond in an effective manner to alleviate the drug shortages in Canada caused by the ongoing pandemic.
The Minister of Health may request the provision of information that is in the possession of the person that sells the drugs based on the following grounds:
- there is a shortage of the drug in Canada or the drug is at risk of going into shortage;
- the shortage or potential shortage is caused, directly or indirectly, by COVID-19;
- shortage of the drug poses a risk of injury to human health;
- the requested information is necessary to assess the shortage, how it occurred and its effects on human health; and
- the person would not provide the information without legal obligation
The person will be required to provide the information electronically within the allotted time period.
Further information on the rationale for this IO can be found in the Explanatory Note.