Question Period Note: DRUG SHORTAGES

Recent media articles have reported that drug shortages in Canada are worsening, highlighting current shortages of cancer drugs, and concerns voiced by healthcare professionals and patients unable to access supply.

What action is Health Canada taking to address drug shortages?

• Our government’s top priority is the health and safety of Canadians.

• I recognize the serious impact drug shortages can have on patients and their families.

• Health Canada takes an active role in identifying drug shortages and mitigating their impact on Canadians, working closely with provinces, manufacturers, and others in the drug supply chain.

• Health Canada will continue to use all available tools to assess and manage critical national shortages when they happen, and work with partners so that Canadians have access to the drugs they need.

IF PRESSED ON HEALTH CANADA’S ROLE IN THE SUPPLY OF DRUGS…

• Drug shortages are a global challenge and concern. My department works with manufacturers and other governments to identify shortages early and to try to prevent them.

• When critical national shortages occur, Health Canada engages stakeholders across the drug supply chain to identify mitigation measures.

• These measures can include facilitating access to international supply and expediting the review of new drug applications.

IF PRESSED ON THE IMPACT U.S. IMPORTATION OF DRUGS FROM CANADA WILL HAVE ON SUPPLIES CRITICAL DRUGS…

• Ensuring that Canadians have access to the medicines they need is a top priority for the Government of Canada.

• Our Government is monitoring developments in the U.S. to better understand the potential implications of the U.S. proposal.

• Health Canada continuously monitors for drug shortages in Canada and works in collaboration with the provinces, territories and other stakeholders to mitigate any impact on Canadians.

• Our Government is committed to safeguarding access to drugs for Canadians.

IF PRESSED ON THE IMPACT US CARAVANS CROSS-BORDER SHOPPING FOR CHEAPER INSULIN IN CANADA…

• Insulin is not regulated as a prescription drug in Canada and can be sold by pharmacies to customers without a prescription, regardless of whether the person is from Canada or the U.S.

• Health Canada is not aware of any current insulin shortages being reported as a result of cross-border purchasing of insulin. The Department will continue to monitor the situation closely.

Health Canada’s role
Health Canada recognizes that drug shortages can have a significant impact on patients and health care professionals and is committed to doing its part to address them when they occur.

Addressing the complex issue of drug shortages is a multi-stakeholder responsibility requiring collaborative action from provinces and territories, manufacturers, distributors, practitioners, and the federal government. When national shortages occur, Health Canada works with provinces and territories and stakeholders across the drug supply chain to determine the details and status of the shortage, coordinate information-sharing, and identify mitigation strategies, which may include regulatory measures and exploring 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

Health Canada also co-chairs the Multi-Stakeholder Steering Committee on Drug Shortages, which mobilizes provinces and territories and key stakeholder groups to play a lead role in advancing tools to address drug shortages.

Mandatory Drug Shortage Reporting
On March 14, 2017, federal regulations came into force requiring drug companies to publicly report drug shortages and discontinuations, including the reasons for the shortage or discontinuation, within a specified timeframe on a third-party reporting website, drugshortagescanada.ca. Timely public communication of drug shortages and discontinuations by drug companies is an essential part of preventing and managing shortages. It helps the drug supply chain and the healthcare system respond appropriately, in order to minimize the impact on patients.

The mandatory reporting website provides access to data, including information related to a specific shortage or company, as well as the ability to download data for further analysis. Having this information accessible to all parties significantly increases the transparency related to the management of drug shortages in Canada.

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