Guidance on releasing information from adverse reaction and medical device incident reports to the public: Overview

On this page

• Purpose
• Background
• Scope

Purpose

This document increases government transparency by providing:

• the Health Products and Food Branch (HPFB) procedures for releasing information from adverse reaction (AR) and medical device incident (MDI) reports to the public
• the Regulatory Operations and Enforcement Branch (ROEB) procedures for releasing information on reports or complaints about medical devices

It outlines:

• a consistent and uniform application of government laws, policies and guidelines governing the public's right of access to information held by government
• Health Canada's duty to protect personal and confidential third-party information in accordance with applicable laws, including the: 
  • Privacy Act
  • Access to Information Act

The report relates to:

• medical devices
• adverse reactions to health products such as:
  • biologics
  • pharmaceuticals
  • natural health products
  • blood and blood components (B/BCs)
  • human cells, tissues and organs (CTOs)
  • sperm and ova for the purpose of assisted human reproduction (AHR)

This document outlines the procedures for providing this information to members of the public including:

• media
• industry
• academia
• consumers
• research communities
• health care professionals

Background

We have collected reports of adverse reactions to health products in Canada since 1965. For marketed health products, these reports are known as adverse reaction or medical device incident reports.

The associated regulations of the Food and Drugs Act and Assisted Human Reproduction Act require important safety information from:

• licensees
• hospitals
• blood establishments
• source establishments
• primary establishments
• medical device licence holders
• market authorization holders (MAH)

They must provide Health Canada with safety information, including adverse reaction and medical device incident reports, about the products they are responsible for in Canada.

Health professionals such as physicians, pharmacists, nurses, dentists, veterinarians and veterinary technicians as well as consumers are encouraged to report adverse reactions and medical device incidents on a voluntary basis.

The type of information collected in adverse reaction or medical device incident reports includes:

• high-level information about the patient or device user
• details of the reaction(s) suspected with the health product(s)
• general findings and the treatment and final outcome(s) of the adverse reaction or medical device incident

Adverse reaction reports and medical device incidents provide information on events suspected to be related to a health product. Each report represents the suspicion, opinion, or observation of the individual making the report. They don't represent all known or possible safety information concerning the suspected product.

Find more information about the adverse reaction and medical device incident reporting programs.

Scope

This procedure applies only to adverse reaction and medical device incident reports from organizations within the:

• Health Products and Food Branch (HPFB)
• Regulatory Operations and Enforcement Branch (ROEB)

From the HPFB, this includes the:

• Biologic and Radiopharmaceutical Drugs Directorate (BRDD), which collects reports on:
  • adverse transfusion reaction/event, clinical trial adverse reaction reports for biological drugs and radiopharmaceuticals and related Special Access Program products
• Marketed Health Products Directorate (MHPD), Canada Vigilance Program, which collects reports on:
  • post-market side effect reports for pharmaceutical drugs, biologics, radiopharmaceuticals, CTOs, B/BCs (donor), AHR, natural health products and medical devices approved for use in humans
  • medical device incident reports for Special Access Program and investigational testing
• Pharmaceuticals Drug Directorate (PDD), which collects reports on:
  • clinical trial adverse reaction reports for pharmaceuticals and natural health products and Special Access Program adverse reaction reports for pharmaceuticals
• Veterinary Drugs Directorate (VDD), which collects reports on:
  • post-market adverse reaction reports for veterinary drugs approved for use in animals

From the ROEB, this includes the:

• Medical Devices and Clinical Compliance Directorate (MDCCD), which collects reports on:
  • medical device problem reports originating from consumers as well as trade and advertising complaints

Learn more about the responsibilities of these organizations.