Initiatives clarify Canadians’ information needs and create predictability for industry
April 2, 2015 - Ottawa, ON - Health Canada
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) received Royal Assent in November 2014, delivering important new drug safety measures for Canadians and also ushering in a new era of transparency around patient safety information.
Health Canada has launched two new initiatives directly related to Act:
- Consultations asking Canadians and healthcare stakeholders about the types of drug safety information they are looking for when making informed health decisions and conducting health safety research; and
- Guide to New Authorities that sets out for industry, researchers and the public the principles, policy and standards that Health Canada will follow when using key new powers.
The consultation is a set of online questions found on Health Canada’s website that is designed to find out more about what Canadians need when seeking information about drug safety. The goal is to use the consultation to develop new tools and regulatory approaches that most effectively meet those needs. Canadian patients, caregivers, researchers and other stakeholders have until May 25, 2015 to provide feedback.
The Guide covers “when”, “how”, and “what” would cause the Minister to make use of the new authorities that are now in force, and explains to “whom” the authorities apply. It provides consistency and predictability for industry as to how the authorities will be applied in areas such as: ordering label changes; disclosing confidential business information in certain circumstances; and ordering recalls. Respondents have until June 8, 2015 to provide feedback on the Guide.
Quick Facts
- Vanessa's Law introduces the most significant improvements to drug safety in Canada since the Food and Drugs Act was introduced more than 50 years ago.
- It enables the Government to: Recall unsafe 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; Compel drug companies to do further testing and revise labels to clearly reflect health risk information in plain language, including updates for health warnings for children; Enhance surveillance by requiring mandatory adverse drug reaction reporting by healthcare institutions; Require new transparency for Health Canada’s regulatory decisions about drug authorizations, both positive and negative;
- Many new tools in the Act came into effect immediately, allowing prompt action to protect Canadians from potentially unsafe medications and medical devices. Others require supporting regulations that Health Canada is now developing which will gradually come into effect.
- Existing mechanisms for accessing drug safety information include Health Canada’s website and searchable databases, direct queries and Access to Information requests.
Quotes
“More than ever before, people want to have an active role in their healthcare decisions. Our Government is committed to providing credible and timely information to Canadians to help them make well-informed choices concerning their health and that of their families.”
Rona Ambrose
Minister of Health
“I’m proud of the great strides our Government has taken to improve drug safety for Canadians. It’s great that we are asking Canadians what information they need access to, and making it clear to industry what’s expected of them. This will definitely reduce adverse drug reactions and help ensure Canadians take prescription drugs more safely.”
Terence Young
Member of Parliament
Associated Links
Vanessa’s Law Royal Assent Announcement
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Contacts
Michael Bolkenius
Office of the Honourable Rona Ambrose
Federal Minister of Health
(613) 957-0200
Health Canada
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