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 Minster;
- 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 health.
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 recall.
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.