On April 2, 2015 Health Canada launched two new initiatives directly related to the Protecting Canadians from Unsafe Drugs Act (the “Act”): (1) The Guide to New Authorities and (2) Consultation with Canadian Healthcare Stakeholders.
As previously reported, the Protecting Canadians from Unsafe Drugs Act received royal assent on November 6, 2014, and became law in Canada. This new legislation is intended to further protect Canadians from the risks related to drugs and medical devices by substantially increasing Health Canada's pre and post-market powers over industry stakeholders, and radically changing the consequences for violating the Food and Drugs Act and its regulations. The Act introduces the most significant amendments to the Food and Drugs Act in 50 years, and represents a new chapter in Canadian drug and medical device regulatory enforcement. The Minister of Health (the “Minister”) now has the authority to:
Require and disclose information if there is reason to believe that the product may present a serious risk of injury to human health;
Order a label change/package modification if there is reason to believe that doing so is necessary to prevent injury to health; and
Order a recall if there is reason to believe a product presents a serious or imminent risk of injury to health.
1. Guide to New Authorities
The Guide to New Authorities (the “Guide”) sets out the principles, policies and standards that Health Canada will follow when using its new powers. The Guide relates to the powers that came into force on royal assent and the remaining powers will be operationalized with the implementation of new regulations.
In particular, the Guide is intended to help provide consistency and predictability for industry as to how the powers will be applied. In so doing, it clarifies “when”, “how”, and “what” would trigger the Minister’s ability to make use of its new powers to: (i) order label changes; (ii) disclose confidential business information; and (iii) order recalls. In addition, it explains, precisely to “whom” the powers apply.
Furthermore, the Guide sets out the considerations to be used to determine whether a therapeutic product (i.e. a drug or device but not a natural health product) presents a serious risk of injury to human health. This non exhaustive list includes: the seriousness of the adverse health consequences; the vulnerability of the patient population; the extent of the population’s exposure to the therapeutic product; and the potential public health impact of the exposure.
While the Guide is already in use by Health Canada, Stakeholder feedback will be considered before the document is finalized. Stakeholders have until June 8, 2015 to provide their comments in writing via email, or to the address below:
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
1600 Scott Street
Holland Cross, Tower B
5th floor, Address Locator 3105A
Ottawa, ON K1A 0K9
Health Canada is asking Canadian patients, caregivers, researchers and other healthcare stakeholders about the types of drug safety information they are looking for when making informed health decisions and conducting health safety research.
The consultations comprise a set of online questions designed to obtain additional information about what Canadians require when seeking information about drug safety. The questionnaire can be found on Health Canada’s website.
Stakeholders have until May 25, 2015 to provide feedback.