The Canadian Life and Health Insurance Association (CLHIA) has created a submission to Health Canada in response to its consultation, Regulatory innovation for health products: Agile licensing for drugs.
The submission expressing the views of the CLHIA’s members discusses changes to processes that are applied when new drugs are brought to market.
“The insurance industry supports the work Health Canada is undertaking to revise drug review processes, resulting in earlier market access for innovative, promising drugs, as well as providing support for funding decisions by publishing up-to-date evidence about an authorized drug’s risks, benefits and uncertainties,” they write.
Adding that the changes won’t be made without risks, the CLHIA recommends close alignment with the requirements of other countries assessing the same drugs, “specifically risk mitigation strategies like the provision of terms and conditions and risk management plans, but also sharing data and clinical trial results that aren’t necessarily replicated in Canada.”
They conclude, saying there are many potential benefits to the agile regulations, but add that the model increases risk to drug plans.
“Insurers are a vital part of the prescription drug funding strategy for Canada. Our data, expertise and responsibilities mean that we are essential stakeholders in Canadian health policy. We are also decision-makers, committed to effective drug plan management for millions,” the letter states. “We need access to accurate, up-to-date information to make informed coverage decisions for our programs. Health Canada’s new agile regulation may introduce more uncertainty into our reviews and clear, transparent reporting and data sharing is necessary to maintain high quality listing decisions.”
