Implementation of Vanessa-s Law

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.