The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) is an Act to amend the Food and Drugs Act. It proposes new rules that will strengthen the regulation of therapeutic products and improve the reporting of adverse reactions by healthcare institutions.
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 will apply to prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices.
It will not apply to natural health products, which will continue to be regulated under the existing Natural Health Product Regulations (NHPR) of the Food and Drugs Act.
Among its key objectives, the new patient safety legislation will seek to:
The Act will increase patient safety in Canada by improving Health Canada's ability to collect safety information on marketed therapeutic products.
The Act will also allow 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 to make new safety information available to patients and consumers.
Fines and penalties will also be 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 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), such as increased fines and penalties, will become law immediately upon Royal Assent.
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.