Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17)
Canada has one of the safest and most rigorous approval systems for therapeutic products in the world. This system has ensured that drugs and medical devices are as safe as possible once they reach the market. In this respect, the Food and Drugs Act has served Canadians well.
However, once products reach the market, Health Canada's ability to gather knowledge about them is limited as is the ability to take action when problems arise. In part this is because the Food and Drugs Act has not been substantially updated in over 50 years.
In response, on December 6, 2013, the Government of Canada introduced legislation that will provide the greatest impact on improving patient safety. The proposed changes to the Food and Drugs Act will improve Health Canada's ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified. Overall, these amendments will provide better protection of patient health and safety, and greater consumer confidence in therapeutic products on the market.
The proposed amendments to the Food and Drugs Act include:
- Power to require information, tests or studies
- This will allow Health Canada to require persons to provide information within their control for the purpose of assessing serious risks to health; and require manufacturers to compile information, conduct new tests or studies, and/or monitor experience, for the purpose of obtaining additional information.
- Power to require a label change
- This will allow Health Canada to require a manufacturer to revise the label of a therapeutic product to include new harm information or to change the brand name or packaging when necessary to prevent injury to health.
- Power to recall unsafe therapeutic products
- This will allow Health Canada to require the recall of a therapeutic product from the marketplace when the product presents an imminent or serious risk to health.
- Tougher measures for those that do not comply
- Changes to the Food and Drugs Act will increase fines and penalties to better reflect the serious nature of the offence, up to a maximum penalty of $5,000,000 and/or 2 years in prison.
- Ability to incorporate by reference
- This involves an authority to reference documents (such as lists or technical standards) in regulations without requiring a time-consuming regulatory amendment each time a change to the document is made.
- Mandatory reporting by healthcare institutions
- Healthcare institutions that are best placed to identify serious Adverse Drug Reactions (ADRs) and medical device incidents will be required to report these directly to Health Canada.
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