Similar to the US Food and Drug Administration’s expanded access program, which allows for those with serious or life-threatening conditions to gain access to experimental medicines, Health Canada opened a draft guidance consultation on changes to its Special Access Program (SAP) for drugs.
The 29-page draft guidance builds on previous guidance adopted
in 2014 and explains how Canadian health care practitioners can obtain access to an unauthorized drug for emergency treatment of a serious or life-threatening condition if conventional therapies have failed, are unsuitable or are unavailable either on the market or via clinical trial enrollment.
New to the scope of the SAP guidance is draft information on the process to request a reconsideration review prior to the issuance of a request denial and a personalized service for urgent life-threatening or end-of-life situations. Required conditions for pre-positioning requests are detailed in the draft as well.
Health Canada says personalized service “provides physicians with the option to access a Health Canada health care professional and will allow direct communication between Health Canada and physicians.”
But similar to how the US expanded access program
works, Health Canada explains: “It is important to note that manufacturers still have the final decision on whether the drug will be supplied to the physician and whether any restrictions or conditions will be imposed on the release of the drug.”
The draft guidance proposes clarifications on the mandate for exemptions under these special circumstances, as well as on the SAP’s intent and scope. It also outlines the request process, including the information requests require, and the responsibilities on practitioners and drug manufacturers throughout the SAP process.
The draft forms part of a larger, ongoing initiative known as “improving the regulatory review of drugs and devices.” It follows on the heels of revisions—proposed
earlier this month—to the regulations that contain the emergency provisions the SAP administers. Health Canada will accept input on the draft guidance, which should be read in conjunction with the proposed revisions, until 19 July.