House of Commons adopts government strengthened patient safety legislation

Amended Vanessa's Law advances transparency commitments

OTTAWA, June 16, 2014 /CNW/ - The Government of Canada welcomes amendments that would strengthen transparency in the proposed patient safety legislation Vanessa's Law (Bill C-17). Since introduction in December 2013, Vanessa's Law has received broad support from members of Parliament, stakeholders and healthcare groups in recognition of the important drug safety improvements that it would deliver, should it become law.

The amendments to Bill C-17 were introduced by Member of Parliament, Terrence Young and adopted by the House of Commons Standing Committee on Health on June 12. The Bill has now passed Third Reading in the House of Commons and moves to the Senate for consideration. The amendments include the requirement that both positive and negative decisions about drug authorizations be disclosed on a public website; and that clinical trial information be disclosed on a public registry. The amendments also better define the scope of confidential business information (CBI) and allow the Minister to disclose CBI about a product if the Minister believes the product may pose a serious risk to Canadians.

The amendments to Bill C-17 would enable Health Canada to continue strengthening its Regulatory Transparency and Openness Framework that was announced in April of this year by the Minister. 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.

Quick Facts

• Vanessa's Law (Bill C-17) would give the Minister of Health new tools to better respond to drug safety issues, such as the power to recall unsafe drugs, impose stiff financial penalties, and require mandatory adverse reaction reporting by healthcare facilities.
• The amendments to the Bill would enhance transparency concerning Health Canada's regulatory decisions, information regarding clinical trials, and the scope of confidential business information and disclosure.
• If passed, Vanessa's Law would provide new tools to make pharmaceutical drugs, biologics and medical devices safer for Canadians.
  
  

Quotes

"The powers included in Vanessa's Law would enable us to take drug safety to a new level.  With the amendments brought forward by my colleague Terence Young, it would now also provide Canadian patients and safety experts with information they have long been calling for. I will also personally ensure that Health Canada continues to find ways to be more open and more transparent with Canadians each and every year.  I've made that commitment.  We will be looking at further steps to ensure that crucial drug safety information is made available to Canadians."
Rona Ambrose
Minister of Health

"Once implemented, Vanessa's Law will save innumerable lives a year in Canada, and prevent tens of thousands of injuries. It is difficult to overstate the importance of this Bill to patient safety. This is a generational change. Vanessa would be very pleased to know that her loss of life has led to the government of Canada acting to prevent others from suffering her fate."
Terence Young
Member of Parliament for Oakville

Associated Links

News Release - Vanessa's Law (December 2013)
Fact Sheet - Taking Action on Patient Safety

SOURCE: Health Canada

For further information:

Michael Bolkenius
Office of the Honourable Rona Ambrose 
Federal Minister of Health
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