Madam Chair, the special access program, the SAP, gives doctors access to non-marketed drugs to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable in Canada. Although emergency access is exceptional and although access to unapproved therapy is optimal in the context of a clinical trial, the SAP can provide limited access to therapies that have been approved in other jurisdictions.
This program is an important way to help Canadians manage their health under exceptional circumstances. To protect patients from the potential risks associated with taking non-marketed drugs, Health Canada has mandatory reporting requirements for doctors accessing the program. They are required to report the outcomes of the treatment sought, including any adverse reactions.
Concerns have been expressed about the SAP's administrative burden and the application process for potentially life-saving therapies. That includes concerns about the information required and the decision-making process, as well as the fact that there is no guarantee the requested drug will be made available and the perception that Health Canada questions doctors' judgment.
Can the minister explain how changes to the Food and Drug Regulations, which came into force on October 14, 2020, will help facilitate timely access to treatments doctors request to treat their patients under exceptional medical circumstances?