Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply): Notice
Date published: November 27, 2020
The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was made on November 27, 2020. This interim order (IO) introduces new measures to help prevent bulk importation programs, such as the one recently established by the U.S., from causing or worsening a drug shortage in Canada. Under the IO, certain drugs intended for the Canadian market are prohibited from being sold for consumption outside of Canada if that sale could cause or worsen a drug shortage.
The IO also authorizes the Minister to require specific information from a manufacturer or drug establishment licence (DEL) holder that could help Health Canada take steps to prevent or alleviate an existing or anticipated drug shortage.
Distribution of drugs for consumption outside Canada will continue to be permitted if the seller determines that the distribution will not cause or worsen a shortage. Drugs manufactured in Canada solely for export are not in the scope of the IO.
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Why the interim order was introduced
Drug shortages are a growing global problem, especially for vulnerable markets, like Canada. Since 2017, approximately 10 to 15% of drugs are in shortage at any given time and almost half (44%) of all marketed drugs in Canada have been in shortage at least once.
Health care providers rely on access to needed drugs to provide proper and timely treatment. Drug shortages can contribute to a number of outcomes, such as:
- adverse patient outcomes, including delayed or cancelled surgeries
- less than optimal care because of the need to use alternative treatments
- discontinued treatment where there is no alternative
- drug rationing
On October 1, 2020, the U.S. Department of Health and Human Services published the final rule on the Importation of Prescription Drugs. The rule creates a pathway for licensed U.S. pharmacists or wholesalers to import, in bulk, certain prescription drugs intended for the Canadian market. Diversion of drugs from the Canadian market would put added pressure on the drug supply, increasing the risk of drug shortages harming Canadians.
How the interim order will address drug shortages in Canada
Under this IO, certain drugs intended for the Canadian market may not be distributed for use outside of Canada if that sale would cause or worsen a drug shortage. This prohibition applies to sales conducted by DEL holders (for example, fabricators, wholesalers, distributors). The DEL holder is required to determine whether the sale could cause or worsen a shortage before the drug is distributed for use outside of Canada. The DEL holder must then make a record showing how this was determined.
This IO focuses on drugs for which a shortage would have the highest impact on patient health and safety. Drugs would include, for example, prescription drugs, controlled substances and biologics. This IO also applies to drugs authorized under the interim order respecting the importation and sale of medical devices for use in relation to COVID-19. However, the sale of drugs for consumption outside of Canada continues to be permitted when it will not cause or worsen a drug shortage. This IO does not apply to drugs manufactured for export (not labelled for the Canadian market).
This IO also introduces a new authority for the Minister to request specific information from drug manufacturers or DEL holders to assess existing and potential shortages. This authority will help Health Canada assess the level of risk for the product that may be experiencing a shortage. This will help inform a decision on measures that may prevent or alleviate the shortage.
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