Question Period Note: DRUG SHORTAGES

• Drug shortages pose a risk to the health of Canadians. The COVID-19 pandemic further exposed vulnerabilities in the drug supply chain that impacted supplies of drugs required to treat patients with COVID-19 and other health conditions.

• The need for vigilance in maintaining the national drug supply continues. Health Canada is continuing its surveillance activities and engagement with key supply chain players to mitigate impacts, and move towards prevention of, drug shortages where possible.

KEY MESSAGES

• Ensuring that Canadians have access to needed medication is a top priority for our Government.
• Significant efforts were made early in the pandemic to respond to drug supply disruptions. Four Interim Orders were put in place to help prevent or alleviate the effects of shortages related to COVID-19 and to safeguard supply. The provisions in these Interim Orders are now being transitioned into permanent regulations.
• A COVID-19 Critical Drug Reserve was also created in collaboration with the provinces and territories to provide a safety net of supply.
• We will continue to collaborate with provinces and territories, industry, healthcare and patient groups and international partners to closely monitor the situation and take necessary action to help prevent and minimize the impact of shortages.

Health Canada’s Role

Drug shortages can have a significant impact on patients and health care professionals.

Addressing the complex issue of drug shortages is a multi-stakeholder responsibility requiring federal leadership and collaborative action from provinces and territories, manufacturers, distributors, practitioners. When national shortages occur, Health Canada works with provinces and territories and stakeholders across the drug supply chain to identify mitigation strategies, which may include regulatory measures, and explore access to alternative products available in other jurisdictions.

Factors such as whether the shortage is national in scope, whether alternative supplies are available and whether the product is considered medically necessary are all considered in determining the potential impact and any necessary actions by Health Canada.

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

This interim order was made on March 1, 2021 to help prevent and alleviate shortages by permitting the exceptional importation of specified drugs, biocides, medical devices, and foods for a special dietary purpose that may not fully meet Canadian regulatory requirements, but are manufactured according to comparable standards. This interim order repealed and replaced the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 that the Minister of Health made on March 30, 2020. On September 2, 2021, the provisions of the interim order were published as permanent amendments to the Food and Drug Regulations, which will enter into force on March 1, 2022.

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

This interim order, made by the Minister of Health on October 16, 2020 introduces new tools for the Minister to address drug shortages, or the risk of drug shortages, that may be caused or exacerbated, directly or indirectly, by COVID-19. The scope excludes shortages of veterinary or natural health products.

This interim order allows the Minister of Health to compel any person who sells a drug to provide information within the person’s control about a shortage or potential shortage of that drug related to COVID-19 under certain conditions. It also allows the Minister to impose or amend terms and conditions on authorizations to sell drugs for the purpose of preventing or alleviating a drug shortage related to COVID-19 under certain conditions.

Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)

This interim order was made by the Minister of Health on November 27, 2020. It introduces new measures to help safeguard the Canadian drug supply by ensuring that bulk importation frameworks, such as the one recently established by the United States, do not cause or exacerbate a drug shortage in Canada. The interim order also enables the Minister to require a seller to provide information that could help Health Canada take steps to assess or alleviate an existing or potential drug shortage.

On September 2, 2021, the provisions of two interim orders above were published as permanent amendments to the Food and Drug Regulations, which entered into force on November 27, 2021.

Engagement with Provinces and Territories in Managing Drug Shortages

Over the last number of years, capacity has been built up across governments, leading to a more coordinated and effective approach to mitigate the impacts of shortages.

Health Canada has strengthened existing mechanisms to manage drug shortages, and has leveraged existing FPT infrastructure and increased cooperation with multiple partners to identify shortage signals earlier, especially for critical drugs required for COVID-19. Through FPT collaboration, a process for the allocation of imported critical drugs is now in place to facilitate the distribution of critical products. The process allows companies the opportunity to work with Health Canada and provincial and territorial governments in allocating supply where it is needed most.

A COVID-19 Critical Drug Reserve was established in 2020, working closely with provinces and territories and other partners, to complement other drug shortage mitigation efforts and includes 12 drugs used to support patients with COVID-19 that have been in high demand or in shortage, including sedatives, pain relievers, antibiotics, muscle relaxants, and inhalers.

Health Canada officials continue to work with the provinces and territories, other international regulators and industry stakeholders to closely monitor Canada’s drug supply so that timely action can be taken to ensure Canadians have access to the drugs they need.

KEY FACTS

• Four Interim Orders were put in place to help prevent or alleviate the effects of shortages related to COVID-19 and to safeguard supply. The provisions in these Interim Orders are now being transitioned into permanent regulations.
• As of December 2, 2021, we have been able to de-escalate 42 shortages from critical status, out of a total of 57 that have been deemed in critical shortage since the onset of the pandemic.