On November 27, 2020, the Minister of Health (the Minister) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order), pursuant to s. 30.1(1) of the Food and Drugs Act.
The current Interim Order is a response to international frameworks which allow for bulk importation of drugs from Canada, which the Minister believes could cause Canadian drug shortages. For example, the US Food and Drug Administration (FDA) published a rule entitled Importation of Prescription Drugs (the US Importation Rule) which permits US pharmacists or wholesalers to bulk import certain prescription drugs initially intended for the Canadian market. The US Importation Rule took effect on November 30, 2020.
Under § 251.2 of the US Importation Rule, drugs eligible for importation must have received an NOC and DIN in Canada and meet FDA approval conditions, aside from US labeling. Controlled substances, biologics, and certain injectable drugs are not eligible for importation.
Interim Order Context
This is the 6th interim order issued by the Minister since the start of the pandemic. The other interim orders include:
- Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 18, 2020)
- Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (signed March 30, 2020)
- Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (signed May 23, 2020)
- Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (signed September 16, 2020)
- Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 (signed October 16, 2020)
The 2nd and 5th interim orders listed above also address drug shortages. They provide the Minister with certain tools to deal with shortages, including the exceptional importation of specific drugs and the ability for the Minister to request specific shortage-related information from anyone who sells drugs.
Interim Order: Safeguarding the Drug Supply
The most recent Interim Order prohibits the distribution of drugs for consumption outside of Canada if doing so would cause or worsen Canadian drug shortages. It applies to all drugs subject to mandatory shortage reporting requirements in Canada. This includes all drugs covered by the US Importation Rule as well as biologics, controlled substances and drugs authorized under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 – the 4th interim order listed above which allows for the expedited review and approval of new COVID-19 drugs and vaccines. The Interim Order does not apply to those drugs manufactured in Canada but intended for export (see s. 37(1) of the Food and Drugs Act).
The Interim Order applies to all sales by drug establishment licence (DEL) holders. It does not apply to non-DEL holders, such as pharmacies. If a DEL holder intends to proceed with a bulk exportation sale, they must have “reasonable grounds” that the sale will not cause or exacerbate a drug shortage and must maintain a record of their justification and rationale for proceeding with the sale. DEL holders can receive guidance to help determine if a sale could cause a shortage.
This Interim Order also requires DIN and DEL holders to provide information about a shortage or potential shortage, upon request by the Minister. In contrast to the 5th interim order, it only applies to DIN and DEL holders and relates to all prescription drugs, not only those related to COVID-19.
Health Canada will enforce this Interim Order through compliance promotion, monitoring, and verification activities. DEL holders who violate the terms of the Interim Order may be subject to enforcement actions, which could include corrective measures, issuance of public communications, or the suspension or cancellation of the DEL.