Amendments have been proposed to the Food and Drug Regulations that relate to the sale of drugs that have not been approved in Canada for emergency treatment. These amendments update the Special Access Program (SAP) and create a mechanism whereby drugs can be purchased for immediate use or stockpiled for public health or Canadian Armed Forces (CAF) emergencies.
I. Changes to the SAP
The proposed amendments are intended to streamline the application process for practitioners in respect of previously approved drugs and clarify when a manufacturer can have an unapproved drug warehoused in Canada in advance of receiving an SAP request.
Health Canada has also published a new draft guidance document indicating how it intends to implement the SAP following these changes. The draft guidance document would replace the existing guidance document dated December 20, 2013 However, the primary substantive changes made to the content relate to the proposed amendments to the regulations.
Consultations on the proposed amendments and draft guidance document are open until July 19, 2019.
Reduced supporting data requirement
Under the present system, a practitioner requesting a drug under the SAP is required to submit supporting data concerning the use, safety, and efficacy of the drug with each request. The proposed amendments are intended to remove this requirement, provided that the following conditions are met:
- The drug has been previously authorized by the SAP for the same medical emergency;
- The drug is authorized for sale without terms and conditions (e., without any further restrictions placed on the drug) by the European Medicines Agency or the United States Food and Drug Administration for the same medical emergency for which the drug is requested; and
- Any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.
This is intended to reduce the burden on practitioners associated with making SAP requests for frequently used drugs.
Importing & warehousing permitted
The present system prohibits importing and warehousing unapproved drugs in Canada in anticipation of an SAP request. For small individual shipments, Health Canada has nonetheless allowed this practice of “pre-positioning” through an exercise of enforcement discretion. This practice is intended to reduce the length of time it takes to get frequently requested drugs.
The proposed amendments will provide clarity by allowing a manufacturer to apply to Health Canada for approval for a drug establishment license (DEL) holder to import and warehouse a drug that may be requested under the SAP for a particular medical emergency. The DEL holder will be permitted to distribute pre-positioned drug in response to a letter of authorisation under the SAP, and will be required to comply with certain good manufacturing practices (e.g., around storage and recall traceability).
Other amendments relating to the SAP
Other amendments to the Regulations relating to the SAP include:
- granting the Minister the power to request a copy of any report that was submitted to a foreign regulatory authority for the purpose of evaluating the safety, efficacy, and quality of the drug;
- removing the requirement that SAP drugs be sent to an institution, allowing them to be shipped to a community pharmacy;
- explicitly allowing SAP requests to be made when the identity of a patient is not known (e., for future use); and
- requiring reporting for veterinary products that contain certain listed antibiotics, similar to those imposed for marketed veterinary products in 2017.
The Regulatory Impact Analysis Statement (RIAS) accompanying the proposed amendments also indicates that Health Canada anticipates having an electronic system for SAP requests in place by the end of 2019.
II. Additional regulations relating to public or CAF emergencies
The government has also proposed a second set of amendments, intended to govern the sale of drugs to public health officials for immediate use or stockpiling in connection with public health or CAF emergencies. This would be achieved by introducing a new Division 11 of the Food and Drug Regulations.
These proposed amendments would also amend the Certificates of Supplementary Protection Regulations under the Patent Act in order to clarify that an authorisation pursuant to Division 11 is not a “prior authorisation for sale” for the purposes of that regime.
The proposed amendments concerning public health/CAF use are published separately from those concerning the SAP, and are the subject of their own draft guidance document. However, the RIAS describing these proposed amendments was included in the RIAS published for the amendments to the SAP. As with those affecting the SAP, these proposed regulations and draft guidance document are open for consultation until July 19, 2019.