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
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;
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
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 Actaccomplished 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
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
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.
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