What is Vanessa’s Law?
Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) amends the Food and Drugs Act. It includes new rules that strengthen the regulation of therapeutic products, and improve the reporting of adverse reactions by healthcare institutions. As well, these measures are intended to improve Health Canada’s ability to collect post-market safety information, and take appropriate action when a serious health risk is identified.
The law is named after Vanessa Young, daughter of the Member of Parliament from Oakville.
How Does this Act Benefit Canadians?
The Act increases patient safety in Canada by improving Health Canada’s ability to collect safety information on marketed therapeutic products.
The Act also allows Health Canada to take quick and appropriate action when a serious health risk is identified, such as ordering a product recall or requiring a label change/package modification to make new safety information available to patients and consumers.
Fines and penalties are increased to better reflect the seriousness of the violation.
In addition to these measures, the Act was also amended by the House of Commons Standing Committee on Health to include new transparency authorities related to clinical trial registration, Health Canada’s regulatory decisions, and disclosure of confidential business information.
Together, these changes will lead to improved patient safety and better health outcomes for Canadians, including vulnerable populations such as children, seniors, and pregnant or nursing women.
The Act enables Health Canada to continue strengthening its Regulatory Transparency and Openness Framework that was announced in April, 2014 by the Minister of Health. The Framework commits Health Canada to a set of concrete initiatives that would make easy to understand regulatory health and safety information more available to Canadians. With this information, Canadians can make well-informed decisions concerning their health and that of their families.
What else will the Act do?
The primary focus of the legislation is to improve patient safety. The Act also provides a new authority to reference technical standards, lists, guidelines or other documents in regulations. Currently, the contents of these kinds of documents or lists are found within the regulations, and can only be changed with a regulatory amendment. The new authority will help to reduce red tape and allow science-based decisions to be made more rapidly.
** All Content and Sources above can be referenced at: Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Questions/Answers – Canada.ca