Proposed changes to the Special Access Program
Due Date: July 15, 2019
Health Canada is proposing changes to the Food and Drug Regulations (FDR) that would affect the Special Access Program (SAP). The changes are part of Health Canada’s plan to modernize the SAP, with the goal of improving access to products that are not currently authorized for sale in Canada.
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The proposed changes would facilitate access to drugs when a drug is needed in the following conditions:
“To treat a patient in a medical emergency where a given drug is either unsuitable or unavailable for sale in Canada (sale of a new drug for emergency treatment); and
To be used by a public health official to address a public or military health emergency, event or incident (public or Canadian Armed Forces health emergencies — drugs for immediate use or stockpiling)”
Draft guidance documents have been written to assist healthcare professionals and manufacturers in complying with the proposed changes to the regulations. These documents should be read in conjunction with the proposed regulations.
I. Sale of a new drug for emergency treatment
The proposed changes would allow for:
A less burdensome process when requesting a drug that has already been authorized by SAP for the same medical emergency. In these cases, data on the use, safety and efficacy of the drug would not need to be submitted; and
Shipment of SAP drugs to community pharmacies.
The proposed regulations would also clarify and explicitly allow for:
Future-use requests, in which the identity of the patient is not yet known; and
“Pre-positioning”; in other words, allowing manufacturers who hold a Canadian Establishment Licence to import and store a drug in Canada, in advance of a specific request. This could allow for a more logistically efficient way of access the drug.
Guidance document: Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs
II. Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling
These changes are intended for public health officials and persons in the Canadian Armed Forces: it is included here in the event some CSHP members are involved in activities related to public health or military emergencies.
Guidance document: Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling
Please see CSHP's response to the Draft Guidance Document for Industry and Practitioners on the Special Access Program for Drugs here .