Today marks the end of Health Canada’s consultation period intended to inform the design of further regulations to the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).
Earlier this year, Health Canada published a discussion paper presenting its proposals for the Food and Drug Regulations and Medical Devices Regulations. The proposed changes to these regulations would make it mandatory for health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).
The consultation period was open for 45 days between June 28, 2017, ending today, and all relevant stakeholders were invited to submit their views. The submissions are intended to help Health Canada assess their proposals and will help to inform the design on the ultimate regulations.
Vanessa’s Law: A Brief Primer
Vanessa’s Law was introduced to Parliament in December 2013.
Prior to the introduction of Vanessa’s Law, the Food and Drugs Act (F&DA) had not been substantially updated in more than five decades. During that time, it became clear that changes to the F&DA were necessary in order to give Health Canada the legislative tools needed to regulate drugs and medical devices more effectively, based on a “life-cycle” approach (i.e- an approach that evaluates drugs both before and after they reach the market).
The life-cycle approach has been adopted by regulatory agencies in other jurisdictions and is based on the fact that some information about safety and/or effectiveness of a drug can only be learned after patients start using the product.
Vanessa’s Law became law on November 6, 2014. It is intended to improve the safety of drugs by broadening Health Canada’s authority over industry stakeholders, and by making the consequences for violating the F&DA, and/or its regulations, more severe.
Only some of Health Canada’s broadened authorities under Vanessa’s Law became effective immediately when the law was passed. This included the Minister of Health’s ability to:
- Require a person to provide information;
- Disclose confidential business information in certain circumstances;
- Order a label change or a package modification; and
- Order a recall.
Further authorities granted to Health Canada under Vanessa’s Law are scheduled to come into force once their respective supporting regulations are established.
On June 18, 2016, the Federal Department of Health published a Notice of Intent advising of its intention to develop additional amendments to the Food and Drug Regulations as well as the Medical Devices Regulations. The amendments were focused on developing the supporting regulations needed to allow Health Canada to exercise some of its further authorities under Vanessa’s Law.
Feedback is generally requested from various stakeholders including:
- health care institutions;
- health care professionals;
- provinces and territories;
- patient advocacy groups;
- biomedical engineers;
- any interested members of the public;
- other interested people or organizations; and
- members of the pharmaceutical and medical devices industry.
Health Canada’s Proposals Regarding ADRs and MDIs
With this most recent round of consultations, Health Canada wants to ensure that serious ADRs and MDIs are reported to Health Canada, so that there is enough information available to readily detect safety problems and emerging safety issues.
Health Canada is seeking advice and input on:
- which kinds of health care institutions should report;
- what types of serious adverse drug reactions and medical device incidents should be reported;
- which health products should be reported on;
- what information should be included in the report; and
- what timelines for reporting should be in place.
Further advice is sought on:
- outreach and education, and
- providing meaningful feedback to reporting institutions.
A summary of Health Canada’s full proposal can be found here.
Feedback received as part of the consultation process will be considered by Health Canada and a summary of the comments will be published in the Regulatory Impact Analysis Statement (RIAS).
We will continue to follow developments in this matter, and will blog about them as information becomes available. In the interim, if you have any questions, please contact us at Wise Health Law. Our team of knowledgeable health lawyers focus on health and administrative law, and are passionate on helping health professionals, public hospitals, and national and provincial health professional associations, among others, find solutions to their legal problems. Contact us online, or at 416-915-4234 for a consultation.