Renewal of the Special Access Programme

From Health Canada

The Special Access Programme (SAP) is undergoing a renewal to make improvements to its processes. The SAP authorizes access to drugs that are not now authorized for sale in Canada, including drugs for rare diseases.

This program is for individual health care providers treating a patient with a serious or life-threatening condition, when normal therapies:

  • have failed
  • are unsuitable
  • are unavailable

The project will update the SAP to:

  • increase transparency of decision making
  • make sure it has authority for current activities
  • reduce paperwork through an electronic system
  • reduce the evidence requirements for “lower risk” drug requests

In addition, the project will put forward new regulations for military and public health emergencies. This will give appropriate authorities for release of large quantities of a drug for:

  • emergency preparedness (stockpiling)
  • response activities by
    • the military
    • public health officials

The tasks for this project include:

  • targeted SAP renewal consultations (late 2017 to early 2018)
  • publishing draft regulations
  • publishing final regulations
  • implementation completed (2020)

We expect that this project will be fully in place by fall of 2020.

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