The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) is a statute that amends the Food and Drugs Act as it applies to therapeutic drugs and medical devices. This set of powers allows the federal Minister of Health to compel information deemed necessary to protect and enforce patient safety. The amendment also requires healthcare institutions to disclose serious adverse drug reactions and medical device incidents. The Act also establishes a regulatory framework that facilitates investment in biotechnology.
The Food and Drugs Act, originally introduced in 1920 and significantly updated once in 1954, was in need of comprehensive revision. Proposed reforms failed when Parliament dissolved in 2008 but high-profile lawsuits against large American pharmaceutical companies and the involvement of Conservative Party back bencher Terence Young, whose daughter died at the age of 15 from the effects of a drug that was still being prescribed despite Health Canada’s awareness of associated risks, helped the bill pass without amendment and become law on 6 November 2014.
The objective of the reform was to update the regulatory framework for pharmaceuticals by: strengthening oversight of the safety of therapeutic products throughout their life cycle; improving reporting of serious adverse drug reactions and medical device incidents that involve therapeutic products; and increasing transparency in the oversight process.
It also established a platform upon which to support the emergent biotechnology sector to allow growth and investment in specialty drugs that target a very small number of individuals more effectively, but do not allow for traditional randomized controlled trials, requiring instead post-market surveillance.
Some aspects of Vanessa’s law will not be implemented until a regulatory framework is fully established. For example, the law requires health care providers to report documented adverse drug reactions but a new framework for documenting adverse reactions is necessary.
Future issues include whether the Minister has the necessary resources to use the powers conferred by the Act and whether the Minister will exercise the newly granted discretionary powers. In the past Health Canada had the legal authority to disclose information in order to prevent harm, but it rarely chose to exercise this authority.
A new framework to document adverse effects may be required in order to allow for proper reporting of adverse effects as mandated by the Act.
The Draft Guidelines might make access to information on pharmaceutical data more difficult because the obligations imposed by the Guidelines upon those requesting access to data, in order to protect commercial interests, conflict with the protection of public health and safety – the main objective of the Act.