More stringent drug-monitoring measures may be on the horizon
for all drugs and medical devices other than natural health
products ("NHPs"). If passed, The Protecting
Canadians from Unsafe Drugs Act (Vanessa's Law)
("Bill C-17") will give the Minister increased powers
intended to strengthen oversight of these products, including the
ability to order:
post-approval assessments, tests, studies, monitoring or
compilation of information on therapeutic products, including
submitting results to the Minister;
submission of additional information post-approval if the
Minister believes there is a serious risk of injury;
label or packaging modifications if the Minister believes it is
necessary to prevent injury; and,
product recalls, stop-sales or corrective action if the
Minister believes there is a serious or imminent risk of injury to
While the legislative summary of Bill C-17 indicates that the
intent is to strengthen oversight of "pharmaceuticals and
medical devices", the definition of "therapeutic
products" is currently broad, encompassing any drug, device or
drug-device combination. The definition specifically excludes NHPs
regulated under the Natural Health Products Regulations;
however, it does not exclude over-the-counter (non-prescription)
products regulated as drugs ("OTCs").
Recalls: Selling a recalled product is
specifically prohibited; however, the Minister can authorize a
person to continue to sell the product, with or without additional
conditions of sale. A person cannot be convicted for selling a
recalled product unless it can be proven that they were notified of
the recall or reasonable steps were taken to notify them of the
Reporting: Aims to improve adverse-reaction
reporting by requiring "prescribed" health care
institutions to report serious adverse reactions involving
therapeutic products. Proposed regulations to implement this
provision are not yet available, so it is unclear which
institutions will be expected to report, the information they will
have to provide or timing.
New Regulations: Provides for new regulations
concerning therapeutic product authorizations, including requiring
authorization holders to provide the Minister with information on
risks communicated outside of Canada, as well as any labelling
changes, recalls, reassessments and suspensions/revocations of
authorizations outside Canada.
Penalties: Provides for fines of up to $5
million for an offence (i.e. contravention of any of the new
provisions), having regard to the nature of the contravention, the
harm or risk that resulted, the vulnerability of affected
consumers, and the existence of a due diligence defence.
While Bill C-17 clearly has the goal of keeping Canadians safe
at its core, there remains certain contentious issues. One of these
issues is the broad definition of "therapeutic products"
to include non-prescriptions products (e.g. lip gloss with an SPF),
inconsistent with Health Canada's Regulatory Roadmap for
Health Products and Foods, which proposes to separate
non-prescription drugs from the framework for prescription drugs.
As the Bill has is only at second reading it is at an early stage
and the final Act may evolve greatly. Grouping OTCs with
prescription drugs also conflicts with ongoing discussions between
Health Canada and industry stakeholders who have been advocating
for the creation of a separate regulatory framework for low risk
consumer health products.
The Protecting Canadians from Unsafe Drugs Act
(Vanessa's Law) was introduced to the House of Commons
December 6, 2013 and is available here.
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