Forward Regulatory Plan: 2019-2021: Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions

Title of Regulatory Initiative

Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions.

Enabling Act

Food and Drugs Act

Description

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) received Royal Assent on November 6, 2014. This legislation, which amends the Food and Drugs Act, includes a new requirement for certain health care institutions to provide Health Canada with information on serious adverse drug reactions (ADRs) and medical device incidents (MDIs). The objectives of this authority are to improve the quality and increase the quantity of ADR and MDI reports, and improve patient safety.

The amendments to the Food and Drug Regulations and Medical Device Regulations will define:

  • applicable health care institutions,
  • types of reportable serious adverse drug reactions and medical device incidents,
  • applicable therapeutic products,
  • applicable data fields, and
  • timelines for reporting.

Regulatory cooperation efforts (domestic and international)

These regulations are not subject to a regulatory cooperation work plan with provincial, territorial or foreign regulatory partners

Potential impacts on Canadians, including businesses

The proposed regulatory change will have a positive impact on Canadians as it will provide additional information to Health Canada on the safety and effectiveness of the therapeutic products used by Canadians. These regulations will help to improve the quantity and quality of reports submitted to Health Canada, thereby enabling Health Canada to make better informed decisions with respect to the safety and effectiveness of therapeutic products in Canada.

As hospitals are not considered to be businesses, these regulations do not have an impact on businesses.

Consultations

The Department has engaged stakeholders since 2015 to provide them with the opportunity to identify issues and potential challenges with implementing a new reporting requirement for health care institutions.

Health Canada held bilateral meetings with the provincial and territorial governments in 2015, and released an issue identification paper in May 2016 that summarized the feedback received with respect to how a new reporting requirement could impact the provincial and territorial health care environments.

A consultation paper on the proposed design of the regulations was posted for stakeholder input in June 2017 with a 45 day comment period.

The Department also held various technical sessions in January 2018 with various implicated stakeholders to gather views on the costs and benefits of the proposal.

Canadians had the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which began in June 2018 and lasted for 75 days.

The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in spring 2019.

Further information

A draft guidance document has been published on the Government of Canada website.

Departmental contact information

Bruno Rodrigue
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

October 1, 2017

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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