As a followup to the recent amendments to Canada's Food & and Drugs Act that came into force on Nov. 6, 2014, Protecting Canadians from Unsafe Drugs Act or “Vanessa's Law,” Health Canada has now posted interpretive guidelines for comment. The deadline for comments is June 8, 2015.
The recent legislative amendments gave Health Canada new powers to address health and safety concerns regarding “therapeutic products” (which includes both drugs and medical devices but not natural health products). These powers include, but are not necessarily limited to:
- issuing orders to require information where there may be concerns relating to serious risk of injury;
- the ability to disclose confidential business information without notice where there are concerns of serious risk or injury or for the protection or promotion of human health or public safety;
- orders to modify product labels and packaging; and
- recall orders.
Of most interest to many in the industry is how the powers of collection and disclosure of information, especially confidential business information will be handled and the effect of same on co-existing access to information legislation. The guidelines provide some insight to Health Canada’s approach to how they will exercise their new powers, including thresholds, triggers and processes.
Although the guidelines are not expansive, they do state that before exercising its power to issue orders requesting information, Health Canada is proposing to first notify the product authorization holder and provide an opportunity to respond.
With respect to disclosure of confidential business information, the guidelines indicate that supporting regulations will be developed with input from stakeholders and in compliance with Canada's international treaty obligations under TRIPS and NAFTA..
The draft guidelines are already in use by Health Canada in the interim but are not finalized pending receipt of comments.
A copy of the Nov. 6, 2014 amendments to the Food and Drugs Act, can be found here.
A copy of the draft guidelines can be found here.
The consultation notice regarding the guidelines can be found here.