Author: Pinkiy Mazumder
With the evolution of healthcare products and its regulations, today we will recap one of the most significant recent changes in Canadian regulations; Vanessa’s Law.
Vanessa’s Law, also known as the Protecting Canadians from Unsafe Drugs Act, was launched with the purpose of strengthening the safety of therapeutic products and its regulation (1). Following the death of 15 year old Vanessa Young from a prescription drug in 2000, Bill C-17 Protecting Canadians from Unsafe Drugs Act, was initiated to propose the first amendment to the Food and Drugs Act in 50 years (1,2). With its introduction in December 6th 2013 by the Federal government, Bill C-17 Protecting Canadians from Unsafe Drugs Act received Royal Assent the following year on November 6th 2014 (3).
The Protecting Canadians from Unsafe Drugs Act applies to therapeutic products including prescription drugs, over-the-counter (OTC) drugs, vaccines, medical devices (including combination drug-devices), gene therapies, cells, tissues, organs, however it does not apply to Natural Health Products (1).
The Act brings multiple new changes to the regulation of therapeutic products, to protect patients and the public from unsafe products. For instance, the Act allows the government to mandate the reporting of adverse drug reactions and medical device incidents by healthcare institutions, and recall therapeutic products that are considered unsafe (1). In addition, for enhanced transparency, the amendment allows the Minister of Health to collect additional product information from the sponsor, require new tests/studies, and monitor patient experience for product assessment (4). Moreover, the Minister of Health also has the authority to demand a re-labelling of drug products or a change in drug packaging for safety concerns, and even reveal confidential business information for product safety (4). These changes, among others, form the basis of Vanessa’s Law. For more information on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), please refer to Health Canada’s Overview of Vanessa’s Law, Amendments to the Food and Drugs Act, and Protecting Canadians from Unsafe Drugs Act Questions/Answers.
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References
1. Protecting Canadians from Unsafe Drugs Act Questions/Answers: http://www.hc-sc.gc.ca/dhp-mps/legislation/unsafedrugs-droguesdangereuses-faq-eng.php
2. Vanessa Young’s Legislative Legacy: http://www.macleans.ca/news/canada/vanessa-youngs-legislative-legacy/
3. Protecting Canadians from Unsafe Drugs Act Amendments to the Food and Drugs Act (Bill C-17): http://www.hc-sc.gc.ca/dhp-mps/legislation/unsafedrugs-droguesdangereuses-eng.php
4. Overview of Vanessa’s Law: http://www.hc-sc.gc.ca/dhp-mps/legislation/unsafedrugs-droguesdangereuses-overview-ensemble-eng.php