Information and privacy notice on public release of clinical information in drug submissions and medical device applications

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• No Confidentiality
• Privacy Notice

The following notice explains how Health Canada will handle information from meetings and correspondence with stakeholders related to implementation of its proposal for public release of clinical information in drug submissions and medical device applications.

Canada's commitment to open government is part of the federal government's efforts to foster greater openness and transparency to provide Canadians with more opportunities to learn about and participate in government and, at the same time, create a more efficient and responsive government.

As part of this commitment, Health Canada is committed to openness and transparency and evidence-based decision making. Health Canada is making more information available to Canadians than ever before and Canadians are being offered more opportunities to participate in discussions on government policies and priorities.

Consultation activities on the public release of clinical information in drug submissions and medical device applications have been designed to promote the involvement of, and consider the views and perspectives of the affected stakeholder groups. This includes but is not limited to: citizens, pharmaceutical and medical device industries, health researchers, health professionals and patient groups.

In line with this commitment, Health Canada invites all stakeholders to provide written comments on the white paper on Public release of clinical information in drug submissions and medical device applications. A summary of comments received during the consultation will be made publicly available.

Please be advised that Health Canada will also publish a list of all comments and correspondence it receives on the white paper, and all meetings with stakeholders in which views, opinions and information (including requests for information) are relayed with the intent to inform the development of policy, guidance or regulations related to public release of clinical information in drug submissions and medical device applications. The table will include the date, subject and purpose of the disclosed meetings and correspondence. The title of any document provided during meetings will also be published.

Oral or written communication for the purposes of making simple enquiries or requests for information and that do not have any relevance to the development of policies related to the public release of clinical information, in Health Canada's view, will not be published.

Personal information will be treated in accordance with the Privacy Act.

For the purpose of this policy, stakeholders are defined as groups, industry, external organizations or advocates to the Government of Canada who have a specific interest in, have some influence on, or are affected by, a given policy, program, regulatory initiative of Health Canada. The definition excludes individuals representing themselves, other levels of government and foreign governments.

No Confidentiality

Information, views and opinions intended to inform the development of policy, guidance or regulations related to public release of clinical information in drug submissions and medical device applications will not be treated confidentially by Health Canada. Health Canada will not accept correspondence or documents marked as confidential in this context.

Meeting notes or documents provided to Health Canada may be released, including in the context of requests under the Access to Information Act.

Privacy Notice

The personal information you provide to Health Canada is collected pursuant to section 4 of the Department of Health Act and is governed in accordance with the Privacy Act.

Purpose of collection: Personal information is used for stakeholder communications related to the public release of clinical information in drug submissions and medical device applications.

Other uses or disclosures: Your personal information may be made publicly available, including on Canada.ca. In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8(2) of the Privacy Act.

For more information: This personal information collection is described in Info Source, available online at infosource.gc.ca. Refer to the standard personal information banks on Outreach Activities PSU 938 and Public Communications PSU 914.

Your rights under the Privacy Act: In addition to protecting your personal information, the Privacy Act gives you the right to request access to and correction of your personal information. For more information about these rights, or about our privacy practices, please contact Health Canada's Privacy Coordinator at 613-948-1219 or privacy-vie.privee@hc-sc.gc.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.