Safeguarding Canadian Drug Supply

Summary#

The Governor in Council approved the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) that the Minister of Health made on November 27, 2020. The approval lets the interim rules stay in effect for one year so Health Canada can limit bulk exports of drugs that are meant for Canadian patients and collect information on existing or possible shortages.

What it does#

• Prohibits holders of a drug establishment licence (DEL) (for example, fabricators, wholesalers or distributors) from selling certain drugs that are intended for the Canadian market to people or businesses outside Canada if that sale would “cause or exacerbate a shortage.”
• Focuses on drugs where shortages would have the highest health impact, including prescription drugs, controlled substances and biologics. It does not cover over‑the‑counter drugs.
• Allows DEL holders to make the sale if they have “reasonable grounds” to believe it will not cause or worsen a shortage; they must keep a record of that determination.
• Gives the Minister of Health the power to require specific shortage-related information from holders of a drug product authorization or an establishment licence. That information must be submitted electronically in a format acceptable to the Minister, within a timeframe set by the Minister (not less than 24 hours’ notice except in cases of serious or imminent health risk).
• Exempts sales by people who are not required to hold a DEL (for example, consumer-level pharmacies), transfers within the same company, and products made in Canada solely for export if they meet the usual export conditions under the Food and Drugs Act.
• Provides for enforcement tools such as inspections, requests for corrective plans, public advisories, licence suspension or cancellation, and possible prosecution.

Who's affected#

• DEL holders: fabricators, wholesalers, distributors who sell drugs that are intended for Canada.
• Holders of a drug product authorization (manufacturers) who may be asked to provide information about shortages or risks.
• Patients and health-care providers who rely on steady access to medicines—especially those using drugs identified as high-impact.
• Consumer-level pharmacies are generally not covered by the prohibition.
• The source notes that groups already more vulnerable to shortages include children, older adults and Indigenous populations.

Why it matters#

• Canada is a relatively small market (about 2% of global drug sales) and imports much of its medicine supply (about 68%), so bulk export or foreign importation programs risk reducing what’s available here.
• Drug shortages are already common (about 10–15% of drugs have been in shortage at any given time since 2017). The Interim Order is a short-term tool to prevent other countries’ bulk-import programs from worsening shortages—Health Canada pointed to 42 Tier 3 (highest impact) shortages in 2020 up to October 20, 2020, versus around 10 in all of 2019.
• The measures give Health Canada clearer authority to gather timely information and to act to protect supply, which can help avoid treatment delays, rationing, or the need to use less‑suitable alternatives.
• The item is an approval of a temporary measure (now in effect for one year); it does not create a permanent legislative change.