Protecting Canadians from Unsafe Drugs Act (Vanessa's Law): Questions/Answers

What is the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)?

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 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.

Where can I find a copy of this Act?

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) can be found on the Parliament of Canada website.

What products are affected by this Act?

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.

What are the key parts of the new legislation?

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:

• Require strong surveillance, including mandatory adverse drug reaction reporting by healthcare institutions;
• Recall unsafe therapeutic products;
• Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
• Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
• Compel drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children; and
• Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.

How will 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.

How does the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) compare with legislation in other countries?

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.

When will the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) become enforceable?

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:

• Ability to recall unsafe therapeutic products
• Ability to impose tougher fines and penalties
• Ability to direct label change/modification, and
• Ability to seek an injunction

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.