Bill C-17, An Act to amend the Food and Drugs Act1 was introduced to Parliament by the Minister of Health on December 6, 2013. The bill proposes a number of amendments to the Food and Drugs Act2 (the Act) which has not been substantially updated in over 50 years. The amendments seek to improve the safety of drugs and medical devices by broadening Health Canada’s powers to include the ability to collect post-market safety information and take appropriate action when a serious health risk is identified.
What Amendments does Bill C-17 Propose?
The amendments proposed by Bill C-17 centre on medical devices and drugs (other than natural health products). The amendments provide a revised definition of medical “device” under s. 2(1) of the Act and a new definition of “therapeutic product” 3.
Of particular note are the amendments empowering Health Canada’s oversight of therapeutic products in the post-market. Specifically, the Minister of Health may:
- require the provision of information for the purpose of assessing serious risks to health;
- require manufacturers to conduct an assessment of the therapeutic product, compile information, conduct new tests or studies and/or monitor experience regarding a therapeutic product and provide the results of such;
- order the recall of a therapeutic product from the market where it presents an “imminent or serious risk to health” or the taking of corrective action with respect to the product; and
- order manufacturers to revise the label of a therapeutic product or packaging if necessary to prevent injury to health.
Also included among the amendments is an obligation on health care institutions to report to Health Canada any serious adverse drug reactions or a medical device incident involving a therapeutic product.
Bill C-17 also proposes harsher penalties for contravention of the Act including a maximum fine of $5,000,000 per day of contravention and/ or up to two years’ imprisonment. Where contravention of the Act is known or undertaken recklessly, a fine determined at the discretion of the court and/ or up to five years’ imprisonment may be imposed. Importantly, even if not prosecuted directly, directors, officers, or agents may be liable for the same punishment as their company if found to have directed, authorized or participated in the commission of the offence.
When will Bill C-17 become law?
Having undergone only its first reading in House of Commons on December 6, 2014, Bill C-17 must still complete various steps in the House of Commons and Senate before it becomes law.
Implications of the Amendments
The modernization of the Act accomplished by Bill C-17 will undoubtedly improve the safety of drugs and medical devices after release into Canadian markets. However, the amendments have other implications worthy of note including:
- “Double Regulation” in the Post-Market: The entry of therapeutic products into Canadian markets is already subject to a rigorous approval system. As a result of the amendments, manufacturers are subjected to additional oversight in the post-market through requirements to provide additional information or conduct further testing and monitoring at the direction of Health Canada. From a products liability perspective, these amendments create an additional layer of regulation on top of that already provided by common-law tort liability and thus, establish a form of “double regulation”. This will inevitably raise the cost of compliance for manufacturers.
- Reduction in Availability of New Drugs and Devices: Notably absent from Bill C-17 is a requirement for Health Canada to make publicly available any documents it is uses in exercising its powers. This lack of transparency will likely raise serious concern over the manner in which Health Canada will exercise its powers, especially its ability to recall products it deems an “imminent or serious risk to health”. Consequently, the amendments may have a chilling effect on the entry of new and beneficial drugs and medical devices into Canadian markets given the uncertainty such products will remain on Canadian shelves.
The amendments proposed by Bill C-17 are slated to bring Canada in line with the post-market regulatory oversight seen internationally for drugs and medical devices. However, its benefits come at a cost. As Bill C-17 makes its way through the legislative process, careful consideration of its implications on the cost of doing business in Canada is necessary.