Development of a Regulatory Framework for Mandatory Reporting by Healthcare Institutions (Vanessa's Law)
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The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) introduces a new power to require certain healthcare institutions to report serious adverse drug reactions and medical device incidents. This requirement is intended to improve the reporting of these types of events and enable the timelier identification and communication of emerging safety issues associated with the use of drugs and medical devices. This power will come into effect when accompanying changes are made to both the Food and Drug Regulations and the Medical Devices Regulations. The regulatory changes will define the applicable healthcare institutions, the data to be provided, and when it must be provided to Health Canada.
To implement a new regulatory framework for a national mandatory reporting program, that provides comprehensive information about these types of adverse events while minimizing the operational impact on healthcare institutions.
Consultations and Next Steps
The implementation of a sustainable and effective framework requires a greater understanding of the evolving healthcare delivery landscape and current reporting programs and systems in place. A series of consultations occurred throughout 2015 and 2016 in which stakeholders responsible for the organization and delivery of healthcare had the opportunity to identify issues and potential challenges with implementing a new reporting requirement for healthcare institutions. An issue identification paper was prepared to summarize the comments that Health Canada received.
With the publication of this issue identification paper, Health Canada will proceed in its analysis of the key policy considerations (such as types of applicable institutions, types of reportable reactions, required data fields, and reporting timelines) for implementing a new reporting requirement for healthcare institutions. The information gathered through consultations, including the comments received on this issue identification paper, will inform this analysis.
How to Get Involved
Health Canada is seeking general feedback of interested parties on the issues identified in the Issue Identification Paper - Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Healthcare Institutions.
This consultation is open for a 60-day comment period starting May 13, 2016 until July 11, 2016.
Please submit your comments via e-mail, fax or by mail.
Policy and International Affairs Section
Therapeutic Effectiveness and Policy Bureau
Marketed Health Products Directorate
200 Tunney's Pasture Driveway
Address Locator 0701L
Ottawa, Ontario K1A 0K9
Fax: (613) 948-7996
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