Vanessas Law promotes greater confidence in the oversight of therapeutic products through the implementation of new transparency measures. These provisions clarify for Health Canada and its stakeholders when the department will actively publish, or disclose upon request, documents, especially those considered as confidential business information during the evaluation process of applications for marketing authorizations and when issuance decisions are taken.
The transparency measures introduced by Vanessas Law:
- Require the Minister of Health to make public decisions regarding therapeutic product authorizations and details of any orders issued respecting a recall, test and study, label change and reassessments;
- Subject to regulations, mandate the public disclosure of information by sponsors concerning clinical trials, such as mandatory registration and the disclosure of summary results; and
- Allow the Minister to disclose confidential business information to the public when it is in the public interest because there may be a serious risk of injury to the health of Canadians.
Some of these measures require regulations to come into force. As part of the regulatory development process, Health Canada will consult Canadians to establish their transparency needs. This consultation will be used to determine how to best meet the end-users' needs and to ensure that information disclosed is meaningful. End-users include patients, healthcare professionals, and academic researchers.
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