Pangaea Express: Health Canada responds to U.S. Drug Importation

HC Interim Order Finally!

Health Canada (HC) has issued an Interim Order (IO) to safeguard Canada’s drug supply from diversion. The IO “builds on consultations started in 2019 with the healthcare community to respond to the United States (U.S.) Importation of Prescription Drugs rule, which comes into effect November 30, 2020”. The IO sends a message to the U.S. that Canada is taking measures to resist U.S. importation proposals, which could help dissuade further actions on importation at the federal and state levels. Drug Establishment Licence (DEL) holders have the obligation to determine whether the sale would cause or exacerbate a shortage and must document how that determination was made. HC has included guidance to assist DEL holders in making their determination including:

• -A shortage has been reported on the Drug Shortages website
• -The product is listed on Health Canada's website as a Tier 3 shortage
• -The drug is known to be provided to the Canadian market by a sole supplier
• -The quantity of the sale is significant relative to the DEL holder's historical sales of the drug in this format
• -The drug is in shortage in other countries and or
• -There are known issues in obtaining APIs for the product

"This IO also gives the Minister the authority to request specific information from drug manufacturers or establishment licence holders to assess existing and potential shortages. Manufacturers and licence holders may be obligated to provide this information if they fail to do so voluntarily."

“Distribution of drugs intended for the Canadian market for consumption outside Canada will continue to be permitted if the seller determines that the distribution will not cause or exacerbate a shortage. Drugs manufactured in Canada solely for export are not in the scope of the IO.”

ASOP Canada applauds the government for issuing this IO to restrict the bulk exportation of certain drugs to the U.S..

This is good news for Canadians to help safeguard our domestic supply of medicines. Florida, which had a large list of Canadian DEL holders the state thought would be itching to become a vendor, has found zero interest. This new Interim Order will now add another layer of challenge for Florida or any U.S. state trying to secure a Canadian vendor to come on board.

For more information, please contact Kristen Knott or Marla Weingarten.