Transparency Measures
Notice to reader:
As of June 22, 2023, the powers conferred by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) apply to natural health products (NHPs). This is because the definition of "therapeutic product" has been revised in the Food and Drugs Act to include natural health products.
The key authorities in the Food and Drugs Act that come into force immediately for natural health products are:
- order a recall of NHPs that present a serious or imminent risk of injury to human health
- require a label change or package modification, if necessary, to prevent serious injury to health
- impose higher fines and penalties for non-compliance
- order a person to provide information to determine if a product presents a serious risk of injury to human health
- disclose confidential business information in circumstances where the product may present a serious risk of injury to human health or for the protection or promotion of human health or the safety of the public
- incorporate by reference, and
- prohibit false or misleading statements or information made to the Minister
The remaining authorities would come into force by an Order in Council later when supporting regulations are published. Supporting regulations would be subject to consultation.
Vanessa's 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 Vanessa's 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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