Health Canada announced on Friday that the department will propose a regulatory amendment to allow access to diacetylmorphine – also known as pharmaceutical-grade heroin, under Health Canada’s Special Access Programme (“SAP”).
A significant body of scientific evidence supports the medical use of diacetylmorphine, for the treatment of chronic relapsing opioid dependence. Diacetylmorphine is permitted in a number of other jurisdictions, such as Germany, the Netherlands, Denmark, and Switzerland, to support a small percentage of patients who have not responded to other treatment options, such as methadone and buprenorphine.
The SAP considers requests for emergency access to drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or are unavailable. Each request made under the SAP is thoroughly reviewed by clinical experts at Health Canada before being granted. Health Canada recognizes the importance of providing physicians with the ability to make evidence-based treatment proposals in these exceptional cases.
Regulatory amendments made in 2013 added diacetylmorphine, and unauthorized products containing benzoylmethylecgonine (unauthorized forms of cocaine), to Part J (Restricted Drugs) of the Food and Drugs Regulations. The amendments also prohibited the consideration of applications under the SAP for any restricted drug.
The proposed regulatory change would move diacetylmorphine to the Narcotics Control Regulations, allowing applications to be considered under the SAP when a doctor considers it medically necessary. Under the proposal, other drugs listed in Part J of the Food and Drugs Regulations would remain available for research purposes. However, they would continue to be unavailable for access under the SAP, consistent with the amendments introduced in 2013, as they currently have no recognized medical use.
While the proposed amendment would enable the careful consideration by the SAP of applications for diacetylmorphine in exceptional cases, all the other stringent controls in the Narcotics Control Regulations will continue to apply.
Health Canada has published the details of this proposal in a Notice to Interested Parties in Canada Gazette Part 1, and stakeholders and members of the public are invited to provide feedback during the 30 day comment period. – CNW