Guidance on Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19

Date published: October 19, 2020

On this page

• Background and objectives
• Guidance on requests for information
• Guidance on terms and conditions for a market authorization
• Compliance promotion

Background and objectives

Protecting the health and safety of Canadians and facilitating access to needed medications is a priority for the federal government.

This interim order (IO) gives the Minister of Health new tools to reduce the impacts of drug shortages related to the COVID-19 pandemic. A shortage is related to the pandemic if a drug is used to treat COVID-19 patients or its availability has been impacted by the pandemic. The IO allows the Minister to:

• require the provision of information and
• place terms and conditions on a market authorization for a drug

Health Canada, the provinces and territories, and stakeholders across the drug supply chain have collaborated extensively in recent years to improve the collective approach to addressing drug shortages. Multi-stakeholder collaboration has been critical in effectively addressing the critical drug shortages that have occurred in Canada because of the COVID-19 pandemic.

This IO recognizes the long-standing multi-stakeholder approach to addressing shortages in Canada and the importance of voluntary collaboration. Under this IO, voluntary action and cooperation will continue to be a priority.

Guidance on requests for information

This IO gives Health Canada the authority to require information from anyone selling the drug in Canada if:

• there is reason to believe a drug could go into shortage due to pressures because of COVID-19 or
• a drug is already in shortage because of COVID-19

The individual selling the drug could be a person or a company. This IO doesn't apply to veterinary drugs or natural health products.

Health Canada will require an individual to provide information if:

• there is a shortage or risk of shortage of the product
• the person selling the drug owns and controls the information being requested
• a shortage of the drug carries the potential of posing a serious or imminent risk to human health
• the shortage or risk of shortage is related to COVID-19
• the information to be provided voluntarily hasn't been received

Under this IO, the person or company is obligated to provide the requested information. The information can be required as quickly as 24 hours after it is requested. It may be used to assess the level of risk for the product going into shortage or inform a decision on measures to prevent or mitigate the shortage.

Guidance on terms and conditions of a market authorization

A market authorization holder (also known as a Drug Identification Number, or DIN, holder) is a company that Health Canada has authorized to sell a drug in Canada. While other players throughout the supply chain have a responsibility for preventing and alleviating the impacts of drug shortages, this section of the IO focuses on actions that can be taken by the DIN holder.

Terms and conditions refer to extra rules or requirements placed on the DIN holder of that product. For drugs that are or may be at risk of a shortage for reasons related to COVID-19, this IO authorizes Health Canada to add terms and conditions to a DIN that require the DIN holder to help prevent or alleviate the impacts of a shortage.

Examples of possible terms and conditions include identifying alternative sources for ingredients or materials or reporting on inventory levels. As a drug shortage changes or evolves, the terms and conditions may also change. They will expire at Health Canada's discretion.

Health Canada will impose terms and conditions on a DIN if:

• there is a shortage or risk of shortage of the product
• a shortage of the drug carries the potential to pose a serious or imminent risk to human health
• the shortage or risk of shortage is related to the COVID-19 pandemic

In addition, the terms and conditions:

• are likely to prevent or alleviate the shortage
• are within the DIN holder's control to implement
• will not make the DIN holder responsible for the business decisions of others

Compliance promotion

Health Canada's focus in implementing this IO is to share information with stakeholders. There will continue to be a strong emphasis on voluntary information sharing and actions to prevent and/or alleviate shortages.

Any compliance verification and enforcement activities for this IO are guided by the compliance and enforcement policy for health products (POL-0001).