As previously reported, the Food and Drugs Act has recently been amended by the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), which received royal assent in November, 2014. Health Canada has now announced two new initiatives related to the Vanessa’s Law amendments.
The first initiative is a consultation on the “Amendments to the Food and Drugs Act: Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall)” (the Guide). The Guide was developed to help Health Canada implement some of the new authorities of the Minister of Health, including the Minister’s authority to require and disclose information, to order a label change/package modification, and to order a recall.
The Guide “sets out principles, policy, and standards to follow when Health Canada identifies situations in which it may be appropriate for the Minister to exercise these new authorities.” In part, the Guide “covers “when,” “how,” and “what” triggers the Minister’s ability to make use of these authorities and explains to “whom” the authorities apply.” One goal of the guide is to increase consistency and predictability as to how the new authorities will be applied. Health Canada also advises that:
The guide is also intended to support the development of the operational tools [e.g., standard operations procedures (SOPs), guidance documents, process maps, templates] needed for those authorities which came into force immediately upon royal assent. It will also guide future regulatory and operational development for those authorities which require accompanying regulations.
Health Canada has advised that the Guide is already in use, but that stakeholder comments on the clarity of the document will be considered before the document is finalized. Stakeholders have until June 8, 2015 to provide comments and suggestions.
The second initiative is the Protecting Canadians from Unsafe Drugs Act Transparency Needs-based Assessment, which seeks feedback on the types of drug safety information different stakeholders are looking for. Health Canada is seeking feedback from a variety of groups, including the general public, patients, health care providers, as well as pharmaceutical and medical device companies or associations representing them. The goal is to use the consultation to develop new tools and regulatory approaches that most effectively meet the drug safety information needs. The consultation is an online questionnaire, available until May 25, 2015.