New Proposed Regulations Would Establish Mechanism to Import and Sell Unauthorized Drugs For an Urgent Public Need

Health Canada has recently proposed amendments to the Food and Drug Regulations to allow the importation and sale of drugs for an urgent public health need.  These proposed amendments would allow the importation of drug products that are not yet authorized for sale in Canada in the following circumstances:

  • A public health official has notified Health Canada in writing of an urgent public health need;
  • The drug is authorized for sale in the U.S., the EU or Switzerland (for the same urgent public health need purpose);
  • The drug is in the same category as the category for which the licence was issued;
  • The drug is imported directly from the country in which it is authorized for sale; and
  • The drug is listed on the “List of Drugs for an Urgent Public Health Need.”

This regulatory proposal could, among other things, provide access to certain opioid use disorder drugs that have not been authorized for sale in Canada.  As noted in the Regulatory Impact Analysis accompanying the proposed regulations, it is sometimes the case that application for Canadian authorization is postponed (or not sought at all) by drug manufacturers because of the relative size of the Canadian market.  The proposed mechanism would be available to bring as-yet unapproved drugs to Canadians in the event of public health emergencies, pandemics and outbreaks. 

Some Things to Note:

  • Importation and wholesale of drugs under this mechanism would only be permitted for authorized establishment licence holders.  
  • Importing establishment licence holders would be required to notify Health Canada within 15 days of the importation, providing prescribed information about the imported product.
  • Health Canada’s oversight powers with respect to recalls, etc. would apply with respect to these products as they do for all drugs sold in Canada.
  • These regulations would not impact Health Canada’s Special Access Program (which is designed to allow access to unapproved drugs on a individual basis).

Because of the urgent nature of the proposal, the consultation period for Canadians to share their views has been shortened to 15 days.  

The draft regulations can be found here.