On October 16, 2020, the Minister of Health (the Minister) signed the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 (the IO), which introduces new tools for the Minister to address actual or potential drug shortages caused, or exacerbated, by COVID-19.  The scope of the IO excludes shortages of veterinary or natural health products.

This IO is the fifth IO to be issued by Health Canada in the context of COVID-19.  The other COVID-19-related IOs are:

Our reports on three of the prior IOs are linked above.

Drug Shortage Information Requests

The IO gives the Minister the authority to require any person who sells a drug to provide relevant information about a shortage or potential shortage of that drug if there are reasonable grounds to believe that:

  • the drug is at risk of going into shortage, or is in shortage;
  • the shortage is caused, or made worse, directly or indirectly, by the COVID-19 pandemic;
  • the shortage poses a risk of injury to human health;
  • the requested information is necessary to identify or assess the actual or potential shortage, why it occurred, its effects on human health, or what measures could be taken to prevent or alleviate the shortage; and
  • the person would not provide the information without a legal obligation.

A person required to provide information must do so electronically in a format specified by, or acceptable to, the Minister, details of which will be specified in industry guidance posted on Health Canada’s website.  The Minister will also specify a time within which the requested information must be submitted.  Any request will also be accompanied by an explanation of the reason for the information request.

The Minister’s new power has certain restrictions:

  • the Minister cannot require that information be submitted with less than 24 hours’ notice, unless the Minister has reasonable grounds to believe that there is a serious or imminent health risk;
  • the Minister can only request information that is in the control of the person who sells the drug at issue;
  • the Minister cannot require a person to create new information; and
  • the Minister cannot request personal information.

New or Revised Terms and Conditions on Drug Authorizations

To prevent or alleviate a drug shortage related to COVID-19, the Minister may also add or amend terms and conditions to an authorization to sell a drug (a market authorization).  The Minister may do so only if there are reasonable grounds to believe that:

  • the drug is at risk of going into shortage, or is in shortage;
  • the shortage is caused, or made worse, directly or indirectly, by the COVID-19 pandemic; and
  • the shortage poses a risk of injury to human health.

Any new or revised terms and conditions will require market authorization holders to take measures related to shortage mitigation and prevention in relation to the authorized drug.  Any such measures will be specifically tailored to the particular drug and shortage at issue, including any related risks.  Health Canada will work with market authorization holders to develop the appropriate measures to be applied.

Examples of terms and conditions include, but are not limited to:

  • identifying alternative sources for raw materials and supplies;
  • developing mitigation strategies to address issues; or
  • reporting on inventory levels on a regular basis.

Market authorization holders will be notified before any term or condition is applied or amended, provided with reasons for the change, and given an opportunity to respond.

The federal government has also published a Guidance Document to further describe the details and application of the IO.

***

Note: this post was updated on March 23, 2021.