Health Canada welcomes comments on release of clinical information on drugs and medical devices

Increased transparency benefits Canadians and the health care system

OTTAWA, Dec 8, 2017 /CNW/ - Health Canada is modernizing its approach to disclosing clinical information on drugs and medical devices to support advances in medical science and help improve patient care. Today, Health Canada published draft regulations in Canada Gazette l that propose to make clinical information in drug and medical device submissions publicly available after the Department has completed its regulatory review process.

Health Canada uses clinical data when making regulatory decisions on drug and medical device submissions. These data provide comprehensive information on the safety and efficacy of these products. Increasing access to clinical data can have widespread benefits for patients and the health care system, for example:  

• Providing more detailed information about drugs and medical devices enables independent analysis that could help health professionals make more informed decisions about their appropriate use; and
• Sharing these data could also help reduce inappropriate use of drugs and medical devices.

In considering how best to make this information more broadly available, Health Canada sought public input on a discussion paper that was published online. It is also consulting expert stakeholders, including industry representatives, academic researchers and healthcare professionals on implementation of these proposed regulations.

The draft regulations are available for public comment for a 75-day period, beginning December 9.

Quotes

"Greater access to clinical information can assist researchers and health professionals, contributing to improved patient safety and better health outcomes for Canadians."
The Honourable Ginette Petitpas Taylor
Minister of Health

Quick Facts

• Clinical data would continue to be treated as confidential business information during Health Canada's review process, including appeal or reconsideration of a decision. It would no longer be considered confidential following the completion of the review.
• Internationally, the European Medicines Agency (EMA) and the US Department of Health and Human Services (HHS) have established or introduced initiatives to share clinical information while protecting privacy and commercial interests. Health Canada's proposed approach to clinical information sharing is aligned with that of other countries, and aims to reduce current administrative burdens while protecting privacy and supporting the medical and research communities.
• In addition to regulatory agency initiatives, pharmaceutical companies have also taken voluntary initiatives to provide qualified researchers with access to clinical data in order to advance medical science or improve patient care.

Related Links

Discussion Paper: Public Release of Clinical Information in Drug Submissions and Medical Device Applications

Guidance Document – Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act

SOURCE Health Canada

For further information: Thierry Bélair, Office of Ginette Petitpas Taylor, Minister of Health, 613-957-0200; Media Relations, Health Canada, 613-957-2983; Public Inquiries: 613-957-2991, 1-866 225-0709