Implementation of Vanessa's Law
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.
Upon Royal Assent, many of the key provisions of Vanessa's Law came into force immediately, including:
- Ability to recall unsafe therapeutic products
- Ability to impose tougher fines and penalties
- Ability to direct label change/package, and
- Ability to seek an injunction
Additionally, Vanessa's Law provides Health Canada with the necessary authorities to implement a life-cycle approach to regulating drugs and medical devices. Bringing the life-cycle amendments into force will require change to current regulations and the development of new regulations. The life-cycle approach provisions which require regulations prior to coming into force include:
- Ability to require tests and studies
- Ability to order a reassessment
- Ability to attach terms and conditions to market authorizations
- Mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions
Health Canada will consult with key stakeholders including patients, academia and industry on the development of the regulatory proposals. As per the usual process, the regulatory proposals will also follow the key objectives set out in the Cabinet Directive on Regulatory Management.