The 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 Canadaĺs 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.
Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) can be found on the Parliament of Canada website.
The Act applies to therapeutic products including prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices.
The amendments brought to the Food and Drugs Act by Vanessa's law do not apply to natural health products, which continue to be regulated under the existing Natural Health Product Regulations (NHPR) of the Food and Drugs Act.
The new legislation will update the law that apply to drugs and medical devices to increase patient safety in key areas of concern and will enable the Government to:
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 Canadaĺs 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.
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.
Canada has one of the safest and most rigorous drug and medical device approval systems in the world. However, the Food and Drugs Act has not been updated in over 50 years. Science and medicine have evolved considerably in those 50 years, and there has been significant progress internationally to improve patient safety through enhanced regulatory oversight of products on the market.
Implementation of this Act will improve patient safety and health outcomes by providing Health Canada with the post-market authorities it needs to better understand the benefits and harms associated with a therapeutic product.
Some of the new powers in the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), come into force immediately upon Royal Assent. These include:
Other changes to the Food and Drugs Act cannot come into force until supporting regulations are published. There will be an opportunity for Canadians to comment on the supporting regulations as part of the regulatory development process.
Several regulatory frameworks, which are linked to the Act, are being developed. These are being developed as part of the Regulatory Roadmap for Health Products and Food.