Health Canada's new standards on conflict of interest

In a CMAJ news piece, Wayne Kondro stated that “Canada has no hard rules governing exemptions or waivers. Experts with conflicts are allowed to sit on [scientific advisory] panels without a formal waiver process.”¹ This is incorrect. Health Canada has been working and consulting with the public on this issue for some time and recently released standards that define conflict of interest for advisory body members and impose standards that are stricter than those of the US Food and Drug Administration (FDA).

Through the department's new Review of Regulated Products: Policy on Public Input,² we are providing opportunities for public input when it can strengthen risk–benefit assessments of regulated products. A new guidance document³ clarifies our practices in managing advice from external experts, including the fact that anyone with a direct financial interest in the outcome of a product review will be barred from participating in an advisory body involved in that review. Unlike the FDA's policy, this is a blanket exclusion, and there are no waivers.

Health Canada places a high value on the expertise that it receives from its advisors, who can be in limited supply. The new policy and the guidance document make clear that only direct financial interest is a bar to participation and that not all affiliations and interests are conflicts. Affiliations may, in some instances, be desirable (e.g., valuable clinical or research experience with a particular drug). Rather than exclusion, our policy supports diversity of perspective, and a range of affiliations and interests in the membership of our advisory bodies, in an effort to obtain comprehensive, credible advice.

Furthermore, the guidance document includes a requirement that background information about advisory body members, including their relevant expertise, experience, affiliations and interests, be made publicly available. Like the FDA, we expect a rigorous, transparent approach to the selection of advisory body members to contribute to public confidence in government decision-making.