Public release of clinical information

From Health Canada

Current Status: Comment period is closed: see next steps Part 2 - call for experts on clinical information release

You're invited to provide comments on proposed changes to permit the release of clinical information related to drugs and medical devices.

We are working to make clinical information about the safety and efficacy of drugs and medical devices available to the public. Information that Health Canada currently treats as confidential would be made publicly available following a final regulatory decision.

Why

Clinical information is data about the safety and efficacy of drugs or medical devices used in humans. Companies that make drugs or medical devices send this information to Health Canada to help us review products for sale in Canada.

Clinical information is submitted in clinical study reports. These reports include information on the design and results of clinical trials. A submission for a single product can include tens of thousands of pages of clinical information, including individual patient data.

Public access to clinical information will allow independent analysis that increases our understanding of the safety and efficacy of health products. This can improve patient care in Canada by:

  • helping patients and healthcare providers make better decisions about using drugs or medical devices
  • reducing research participant exposure to harm during duplicative studies
  • using analysis of existing data to advance new research

Who

We are looking for comments from:

  • health researchers
  • health professionals
  • patient groups
  • pharmaceutical industries
  • medical device industries

What

Health Canada is looking for stakeholder's comments on how it carries out this proposal, including the:

  • regulatory approach
  • scope of clinical information that would be publicly available following a final regulatory decision
  • clinical information that has ongoing commercial value and could be withheld from public release.

When and where

Written comments can be provided on-line for 75 days from March 10 to May 26, 2017.

In-person meetings with stakeholder groups and technical experts will be scheduled from spring to fall of 2017.

How to participate

Please read our white paper and submit your comments using our comment form.

If you have questions or comments on this document, please email us.

All comments must be received by May 26, 2017.

Next steps:

Part 1 consultation is now closed

Written submissions will be available on this site following completion of the public comment period.

We will also publish a list of all meetings and communication with stakeholders about our proposal for public release of clinical information, and will make meeting documents available on this site.

Part 2 - Call for experts on clinical information release

Health Canada is now calling for experts available to advise on 6 specific areas related to releasing clinical information in drug submissions and medical device applications.

The 6 areas needing expertise in the Canadian context are:

  • data protection and privacy law
  • health data science and statistics
  • open data and end-user experience
  • clinical trial reporting, medical writing
  • anonymizing and de-identification methods
  • regulatory affairs and common technical document (CTD) structure

We will consult selected experts individually, as needed, on subjects in their areas of expertise. Consultation will be by email and teleconference and will not be remunerated.

Expert advice will contribute to our analyses and recommendations, which will be presented for feedback from stakeholders, including drug and medical device manufacturers, health care providers, academic researchers and patient groups.

Interested experts should be available between June and December 2017.

To express your interest and for more information, please contact us no later than June 16, 2017.

For more information see the information and privacy notice.

In the fall of 2017, Health Canada intends to propose draft regulations to support public release of clinical information in drug submissions and medical device applications. There will be further public consultations after the draft regulations are published.

Related information

Contact us

Mailing address:
Office of Information Management
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Graham Spry Building
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

Telephone: 613-404-3614
Email: rmod_stakeholders-intervenants_dgro@hc-sc.gc.ca

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