On December 6, 2013, the Minister of Health introduced Bill C-17, the Protecting Canadians from Unsafe Drugs Act. If enacted, the provisions of the new legislation will amend the Food and Drugs Act in several significant ways.
The proposed legislation will grant the Minister of Health new powers to investigate and deal with safety issues relating to "therapeutic products". The new definition of therapeutic product will include prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices, but will exclude natural health products[1].
In relation to therapeutic products, if the Minister of Health believes that a serious risk of injury to human health is presented, he/she will be able to demand provision of information from any person in order to assess the risk posed. The Minister of Health will also be able to (i) order that manufacturers make label changes to a therapeutic product as deemed necessary to prevent injury to health and (ii) order recalls if it is believed that a therapeutic product poses a serious or imminent risk of injury to health. Furthermore, the Minister will have the power to order that manufacturers conduct assessments, compile information, conduct tests/studies and monitor experience in respect of therapeutic products and report the results back to the Minister.
The power to obtain information arising out of the conduct of clinical trials/investigational tests of therapeutic products will also be extended by giving the Governor-in-Council the ability to promulgate regulations requiring entities that conduct clinical trials/investigational tests to report on safety information that they become aware of after the trial/test is completed or discontinued. The Governor-in-Council would also be empowered to issue regulations requiring that manufacturers report on information in respect of any serious risk of injury to human health of which they become aware relating to the safety of a therapeutic product, including risks communicated outside of Canada, labelling changes implemented outside of Canada and recalls conducted outside of Canada[2].
The proposed legislation will also require mandatory reporting of serious adverse drug reactions or medical device incidents by health care institutions. The types of "health care institutions" subject to this obligation are to be defined by regulation. It remains to be seen whether the definition will give rise to a debate about the proper delineation of federal versus provincial jurisdiction over health care and the operations of health care institutions.
Penalties for violating the Food and Drugs Act and associated regulations will undergo a hefty increase under the proposed legislation to $5,000,000 per day (from the current maximum of $5000). Penalties could be even higher if a person has knowingly or recklessly caused a serious risk of injury to human health.
The publicity surrounding the introduction of Bill C-17 has emphasized the enhanced powers created in favour of the Minister of Health. Practically speaking, however, the Minister of Health can already effect label changes and/or recalls of drugs and medical devices and require submission of information relevant to the safety and efficacy of these products, through dialogue with drug and medical device manufacturers and, ultimately, the power to suspend marketing authorizations for products that are deemed unsafe or ineffective. Arguably, the most significant changes found in the proposed legislation are the increased penalties for non-compliance with the law, which may signal the advent of a more aggressive approach to enforcement in matters relating to drug and medical device safety.
[1] Natural health products continue to be regulated under the Food and Drugs Act as a subset of drugs.
[2] The current law relating to drugs only requires reporting of serious unexpected adverse drug reactions that occur outside of Canada (serious adverse drug reactions that are not identified in the risk information set out in the label of the drug). The current law relating to medical devices requires reporting of certain incidents outside of Canada, but only if the manufacturer has informed the regulatory agency of the country in which the incident occurred of an intention to take corrective action or if the regulatory agency has required the manufacturer to take corrective action.
