Forward Regulatory Plan 2021-2023: Proposal to restore potential access to restricted drugs through Health Canada’s Special Access Program

Title of Regulatory Initiative

Proposal to restore potential access to restricted drugs through Health Canada’s Special Access Program

Enabling Act

Food and Drugs Act

Controlled Drugs and Substances Act

Description

Health Canada has proposed to reverse regulatory changes made to the Food and Drug Regulations (Parts C and J) and the Narcotic Control Regulations in 2013, which prohibited access to restricted drugs through the Special Access Program (SAP) and added unauthorized products containing cocaine to the definition of restricted drug.

Regulatory cooperation efforts (domestic and international)

Not applicable

Potential impacts on Canadians, including businesses

Reversing the regulatory amendments made in 2013 would mean that, in practice, health care practitioners could, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Stakeholders that may be impacted by the change include health care practitioners and patients with serious or life-threatening conditions. While reversing the 2013 regulatory amendments would not guarantee that restricted drugs would be approved through the SAP, this change could provide an additional potential option for practitioners treating patients in instances where other therapies have failed, are unsuitable, or are not available in Canada.

Consultations

Interested parties were invited to provide comments on a Notice of Intent, which was published in the Canada Gazette, Part I, on December 12, 2020, for a public comment period that ended on February 10, 2021.

Publication of the regulatory amendments in the Canada Gazette, Part II, is expected to take place in fall 2021.

Further information

Additional information can be requested from the departmental contact.

Departmental contact information

Jennifer Pelley
Acting Director
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada

Telephone: 613-410-1829
Email: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2021

Consult Health Canada's acts and regulations web page for:

• a list of acts and regulations administered by Health Canada
• further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

• Federal regulatory management
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To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

• Consulting with Canadians
• Canada Gazette