Forward Regulatory Plan 2019-2021: Regulations Amending Certain Regulations Made Under the Food and Drugs Act: Sale of a New Drug for Emergency Treatment under the Special Access Program and Emergency Drug Release Program for Veterinary Drugs.

Title of Regulatory Initiative

Regulations Amending Certain Regulations Made Under the Food and Drugs Act: Sale of a New Drug for Emergency Treatment under the Special Access Program and Emergency Drug Release Program for Veterinary Drugs.

Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)

Enabling Act

Food and Drugs Act

Description

This regulatory proposal aligns with the Government's commitment to provide more timely access to drugs and devices through the Regulatory Review of Drugs and Devices initiative.

Renewal of the Special Access Programme for Drugs and the Emergency Drug Release Program for Veterinary Drugs

The current provisions for the sale of drugs for a medical emergency (Sections C.08.010 and C.08.011 of the Food and Drug Regulations) would be amended to provide appropriate authorities for current program operations, such as authorizing requests for unknown patients in anticipation of a medical emergency.

Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies):

Current emergency provisions in the Food and Drug Regulations do not cover emergency preparedness and response activities undertaken by federal, provincial, territorial or municipal Public Health Officials responsible for public health or the Surgeon General of the Canadian Armed Forces responsible for military health.
A new regulatory framework is proposed that would provide appropriate authorities to reflect current operations, facilitating access to unauthorized drugs that could be used to treat mass populations during a Canadian public or military health emergency, e.g., pandemic influenza vaccine, antivirals, etc.

Regulatory cooperation efforts (domestic and international)

These initiatives are not subject to a regulatory cooperation work plan with provincial, territorial or foreign regulatory partners; however, elements of the proposal related to the sale of a new drug for emergency treatment rely on the confidence that exists between Health Canada and other specified foreign regulators as a result of collaboration, harmonization and other regulatory confidence building activities.

Potential impacts on Canadians, including businesses

These amendments will allow for more timely delivery of drugs for emergency treatment by allowing requests for future use and prepositioning of drugs in Canada in anticipation of requests. They will also reduce administrative burden on health care professionals who request drugs frequently accessed via the program.
These amendments will address a long-standing recommendation of the Office of the Auditor General. They will allow for adequate oversight of unapproved drugs to be used on large populations during public health and military emergencies, thereby affording more protection to Canadians.

Consultations

Health Canada engaged in targeted consultations between December 2017, and September 2018.

A regulatory proposal was pre-published in the Canada Gazette, Part I on May 11, 2019 for a 70 day comment period.

The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in spring 2020.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

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

April 1, 2018

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:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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