Special Access Programme - Comprehensive Review

What is the Special Access Programme?

Health Canada, through its Special Access Programme (SAP), allows practitioners or health care professionals to gain access to unauthorized drugs or medical devices that have not yet been authorized for sale in Canada through a regulatory exemption.

More detailed information on the SAP for drugs and on the SAP for medical devices is available.

Why is Health Canada reviewing the Special Access Programme?

In recent years, there has been increasing focus on the timely access to new therapeutic products by Canadians. While this has fostered changes to the regulatory review process, it is recognized that the SAP plays a role by providing access to products that have not yet obtained market authorization. Manufacturers, practitioners and patients have asked for improved access to drugs and devices requested through the SAP.

In response to comments from stakeholders and users, Health Canada has undertaken a comprehensive review of the SAP to modernize the policy and regulatory frameworks supporting the Programme.

How will Health Canada be reviewing the Special Access Programme?

The SAP comprehensive review consists of three sub-projects: an operational review to evaluate how the SAP for drugs is functioning within its existing framework; an ethics review to study the ethical context of the mandate and activities of the Programme; and a broad policy/regulatory review. Issues identified in the operational and ethics review will feed into this broad policy/regulatory review. The main objective is to update the Programme's regulatory and policy framework for drugs and further define its mandate and authorities.

Consultation Process

To develop options for a modernized Special Access Programme for drugs and medical devices, Health Canada began consulting with Canadians on the Programme's regulatory and policy framework at the beginning of 2007 through a three-phased consultation process.

Phase 1 - Identifying the Issues

In June 2007, Health Canada held consultations in Vancouver and Ottawa with users of the SAP about their experiences, issues and suggestions for updating the Programme. In addition, several bilateral meetings with stakeholders and provincial health partners were held to further identify issues.

Phase 2 - Validating the Issues

The issues identified by stakeholders during Phase 1 consultations have been included in an Issue Identification Paper. From November to December 2007, Health Canada held an online consultation to seek feedback on those issues.

Next Steps

Phase 3 - Developing Options

Health Canada will use the results of the Phase 2 online consultation to develop initial options for a new and modernized framework for the Special Access Programme in an Options Discussion Paper. An Expert Advisory Panel on the SAP has been convened to provide advice on consideration of options contained in the paper. This Options Discussion Paper will be revised and all interested Canadians will be invited to comment on the options proposed in the paper. More information on this activity will be posted soon.

Reporting to Canadians

The results of the consultations of Phase 2 & 3 will be made publicly available on the Health Canada Web site.

Need more information?

To obtain more information, you can reach us by:

• E-mail: special_access_programme_review@hc-sc.gc.ca
• Fax: 613-941-6458
• Mail:
  Special Access Programme - E-consultation
  Health Canada - Therapeutic Products Directorate
  Bureau of Policy, Science and International Programs
  1620 Scott Street, Tower B
  Ottawa, ON K1A 0K9
  A/L 3102C5