Key Takeaways:
- Health Canada plans to speed up reviews of some medications by relying on the decisions of foreign regulators, such as the US Food and Drug Administration.
- The move aims to reduce the time it takes to authorize new drugs, including cheaper generic copies of medicines already on the market.
- Some experts warn that relying on foreign regulators could water down Health Canada’s standards and lead to a reduction in the number of scientific reviewers on staff.
- The draft ministerial order outlines three ways Health Canada could rely on foreign regulators, including deeming parts of a drugmaker’s submission as already completed if the drug has been approved by a trusted foreign regulator.
- The Canadian Generic Pharmaceutical Association and Innovative Medicines Canada will participate in a public consultation to provide feedback on the proposed changes.
Introduction to the Proposal
Health Canada is planning to accelerate the review process for certain medications by leveraging the decisions of foreign drug regulators, potentially including the US Food and Drug Administration (FDA). This move is part of the federal government’s effort to cut red tape and address concerns from the pharmaceutical industry and patients about the lengthy approval process for new drugs. The draft ministerial order, published before the holidays, outlines the proposed changes, which aim to reduce the time it takes to authorize new medications, including generic copies of existing drugs.
Concerns about Relying on Foreign Regulators
Some experts have raised concerns that relying on foreign regulators could compromise Health Canada’s standards and lead to a reduction in the number of scientific reviewers on staff. Matthew Herder, director of the Health Law Institute at Dalhousie University, expressed particular concern about the potential inclusion of the current FDA on the list of trusted foreign regulators, given the agency’s recent turmoil and job cuts under the Trump administration. Herder noted that even before the current upheavals, the FDA and other major regulators, such as the European Medicines Agency (EMA), sometimes differed from Health Canada in their assessments of new pharmaceuticals.
Proposed Changes to the Review Process
The draft ministerial order outlines three ways Health Canada could rely on foreign regulators. Firstly, the Canadian regulator could deem parts of a drugmaker’s submission as already completed if the drug has been approved by a trusted foreign regulator. Secondly, Health Canada could draw on elements of in-progress reviews by another drug authority, provided companies file in Canada within 120 days of applying to the other regulator. Finally, Canada could conduct more joint reviews with foreign regulators. Some of Canada’s peer countries, including Australia, Switzerland, Britain, and Singapore, have pathways to approval that rely to some degree on the decisions of foreign regulators.
Industry Response and Public Consultation
Innovative Medicines Canada (IMC), the industry group for brand-name drug makers, expressed general support for efforts to make the Health Canada approval process faster and more efficient. The Canadian Generic Pharmaceutical Association urged Health Canada to prioritize timely reviews and approvals of cheaper generics to help lower the prices patients pay for medications. Both groups will participate in a public consultation, which runs until February 28, to provide feedback on the proposed changes. The consultation will help determine which foreign regulators and drugs will be included in the initial list, with potential classes of drugs including those for pets, food-producing animals, and children.
Potential Benefits and Implications
The proposed changes could have significant benefits, including reducing the time it takes to authorize new medications and increasing access to cheaper generic drugs. Adam Houston, an adjunct professor of health law at the University of Ottawa, hopes that a streamlined process will persuade pharmaceutical companies to apply to sell in Canada child-friendly formulations of certain drugs that are authorized elsewhere, such as drugs for tuberculosis. However, experts also caution that relying on foreign regulators could have unintended consequences, including a reduction in the number of scientific reviewers on staff and potential compromises to Health Canada’s standards. As the public consultation gets underway, it remains to be seen how the proposed changes will be implemented and what impact they will have on the Canadian pharmaceutical landscape.