Health Canada Consultations
Notice of intent to amend the Food and Drug Regulations and the Narcotic Control Regulations to restore potential access to restricted drugs through Health Canada’s Special Access Program
This notice provides interested parties and the general public with the opportunity to comment on Health Canada’s intention to reverse regulatory changes made to the Food and Drug Regulations (Parts C and J) and the Narcotic Control Regulations in 2013, which prohibited access to restricted drugs, heroin, and unauthorized products containing cocaine through Health Canada’s Special Access Program (SAP). In 2016, these regulatory amendments were partially reversed, allowing for the consideration of applications made to the SAP for diacetylmorphine (i.e. heroin).
Based on recent scientific advancements and the potential for some restricted drugs to have therapeutic benefit, the objective of the current proposal is to restore the possibility of access to restricted drugs through Health Canada’s SAP, by reversing the remaining 2013 regulatory amendments. In practice, this would mean that practitioners could, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP in instances where other therapies have failed, are unsuitable, or are not available in Canada.