On December 6, 2013, the Canadian government introduced Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law1), which contains proposed changes to the Food and Drugs Act (the Act).
The amendments are directed to therapeutic product post-market (rather than pre-market approval) issues that are intended to improve Health Canada's ability to both collect post-market safety information and take appropriate action when a serious risk to health is identified.
The scope of the proposed changes includes medical devices and drugs (other than natural health products). Among the amendments is a revised definition of medical "device" under s.2(1) of the Act and a new definition of "therapeutic product" which would expressly encompass medical devices and drugs (and would exclude natural health products).
The proposed amendments to the Act include provisions to strengthen safety oversight of therapeutic products throughout their life cycle and include:
- empowering Health Canada to require manufacturers to compile information and conduct tests for the purpose of obtaining additional information;
- empowering Health Canada to require a label change to include new harm information;
- empowering Health Canada to recall unsafe therapeutic products; and
- increasing fines and penalties to better reflect the serious nature of an offence, up to a maximum penalty of $5,000,000 and/or two years in prison.
In addition, the amendments aim to improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products. If the proposed amendments are enacted, healthcare institutions will have the obligation of reporting such incidents directly to Health Canada.
Bill C-17 has not yet been passed, and must proceed through various steps before the House of Commons and Senate before becoming law.
For more information, the full text of Bill C-17 can be found here.
1 The Canadian government named the Act for Vanessa Young. http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-174-eng.php
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