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
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
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.
"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."
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."
Member of Parliament for Oakville
News Release - Vanessa's Law (December 2013)
Fact Sheet - Taking Action on Patient Safety
SOURCE: Health Canada
For further information:
Office of the Honourable Rona Ambrose
Federal Minister of Health
Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media