The CMA is working with governments and other stakeholders to inform the implementation of new federal legislation known as
Vanessa’s Law was passed in November 2014 and brought into effect significant changes to the
Food and Drug Act.
Vanessa’s Law establishes new powers for Health Canada to better address patient safety related to pharmaceuticals and medical devices. It is the most significant change to this legislative framework in over 50 years. Under
Vanessa’s Law, some of the new authorities include the ability for the Minister of Health to:
- recall unsafe therapeutic products;
- require companies to modify or replace labels or packaging;
- require companies to provide information, undertake new tests and studies, and conduct product assessments if there is a concern that a product constitutes a serious risk to health; and,
- impose higher penalties for lack of compliance.
In keeping with the CMA’s priority that Canadians have access to medically necessary drugs that are safe, effective, affordable and appropriately prescribed, the CMA has actively engaged in Health Canada consultations on the new regulations and guidelines needed to implement
Vanessa’s Law also establishes a new requirement for health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents to federal authorities. Presently, reporting by health care professionals is voluntary.
Along with other professional and health care groups as well as provincial and territorial health officials, the CMA has raised its concerns about the burden of reporting for health care professionals and institutions under the forthcoming regulations. As such, the CMA is strongly supporting increased investment by Health Canada to improve its reporting tools, response capabilities and the timeliness and quality of information provided to physicians and patients.
To ensure these new regulations are designed to improve the overall surveillance system, the CMA is recommending that the requirement to report serious ADRs be limited to patients admitted to hospital for at least 24 hours. This stipulation would capture most serious ADRs and situate reporting within institutions with better diagnostic and reporting capacity, the CMA noted.
Exceptions to this would include situations where a death attributed to an ADR or medical device incident occurred out of hospital.
To improve the existing surveillance system, the CMA also recommends:
- Making the reporting system user-friendly and easy to incorporate into a practitioner’s schedule;
- Incorporating the reporting process into the Electronic Health Record system;
- Augmenting ADR reports with other information gathered through such means as formal post-market studies of specific drugs or “sentinel” groups of health care professionals contracted to report ADRs in depth.
The CMA will continue to be involved as Health Canada’s consultation with governments and stakeholders progresses.
Related CMA briefs:
CMA’s Response to Health Canada’s Consultation Questions. Regulatory Framework for the Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare Institutions (January 2016)
CMA's Response to Health Canada's Public Consultation Guide to New Authorities in reference to Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) (August 2015)
Bill C-17 An Act to amend the Food and Drugs Act - Protecting Canadians from Unsafe Drugs. Submitted to the House of Commons Standing Committee on Health (June 2014)