Bill C-17 · 41th Parliament · Stephen Harper
Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
An Act to amend the Food and Drugs Act
Government bill. Became law.
- IntroducedDec. 6, 2013
- Debated in principleMay 30, 2014
- Studied by a committeeDone
- Passed its first chamberJune 16, 2014
- Passed the second chamberOct. 22, 2014
- Became lawNov. 5, 2014
Leading supporters
Ranked by the part each played: who is responsible for the bill, who carried it, and who spoke for it most.
- Stephen HarperPrime Minister
Who carries this bill
Arrows run from the person responsible to those who answer to them on this bill. The critic leads the Senate’s scrutiny and answers to no one on it.
What it set out to do
On 6 December 2013, the Minister of Health introduced Bill C-17, An Act to amend the Food and Drugs Act (Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)) in the House of Commons and it was given first reading. Bill C-17 amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things, • strengthen safety oversight of therapeutic products throughout their life cycle; and • improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products.
Summary by the Library of Parliament.
Where members stand
Votes and debate for this bill have not been read yet.
How it changed on the way
78% of the text as introduced was changed or removed by the time it became law (4,251 words introduced, 4,037 passed). A committee amended it.
substantial changeintent broadened
The bill kept its core safety and reporting rules but added a new transparency purpose and several disclosure rules. These changes let the minister release confidential business information and require orders to be made public.
- Added transparency as a third purpose of the Act.
After: “and (c) promote greater confidence in the oversight of therapeutic products by increasing transparency.”
- Added definition of confidential business information.
After: “"confidential business information", in respect of a person to whose business or affairs the information relates, means — subject to the regulations — business information”
How precisely it is written
mixedChallenging the law: ModerateDisputing a charge: Moderate
The bill supplies exact dollar limits, prison terms and defined terms for devices and therapeutic products, yet most enforcement powers turn on the Minister's subjective beliefs about risk. This mix of numeric precision and open-ended discretion produces a law that is neither fully black-and-white nor wholly indeterminate.
Open to argument
“If the Minister believes that a therapeutic product may present a serious risk of injury to human health”
The trigger rests on the Minister's personal belief rather than an objective, measurable standard.“The Minister may, if he or she believes that doing so is necessary to prevent injury to health”
The necessity test is left to ministerial opinion without statutory benchmarks.“is about to do or is likely to do anything that constitutes or is directed toward the commission of an offence”
The 'likely to' standard invites prolonged argument over future conduct.
Clear-cut
“on conviction by indictment, to a fine not exceeding $5,000,000 or to imprisonment for a term not exceeding two years or to both”
Maximum penalties are stated in fixed numbers that require no further interpretation.“Due diligence is a defence in a prosecution for an offence under this Act, other than an offence under section 31.4”
The availability of the defence is stated categorically.
Discretion. Ministers and officials retain wide latitude to decide when a 'serious risk' exists, what information is 'necessary', and whether corrective action is 'effective', with many details left to regulations.
Challenging the law itself. Broad grants of power keyed to ministerial belief could be attacked under Charter s. 7 for vagueness or overbreadth, though the regulatory context makes success uncertain.
Disputing a charge under it. A person facing charges can readily dispute whether the Minister's belief was formed reasonably or whether the risk met the statutory threshold, turning on contested facts and opinions.
Read by a language model from the royal assent text; every quoted phrase appears in the bill. A reading of the drafting, not legal advice.
Did it work?
no evaluation found
No statutory reviews, Auditor General reports, departmental evaluations, or peer-reviewed studies directly assessing whether Vanessa's Law achieved its goals of strengthened safety oversight and improved adverse reaction reporting for therapeutic products were identified. Limited related evidence includes a 2018 Federal Court ruling on its transparency provisions and references in a 2021 CESD audit recommending extension of its powers to natural health products.
- Doshi v. Attorney General of Canada, 2018 FC 710courtFederal Court ruled Health Canada's refusal to disclose clinical trial data unreasonable, citing Vanessa’s Law purpose of improving transparency.
- Commissioner of the Environment and Sustainable Development Report 2 – Natural Health Products (2021)auditRecommended extending Vanessa’s Law powers to natural health products to address compliance gaps, implying its value for other therapeutic products.
Who lobbied on it
No lobbying registration naming this bill is loaded.
Stages and dates from LEGISinfo.