From 2018-01-10

In a little-noticed announcement in October 2017, Health Canada signalled its intention to raise the fees that drug makers will have to pay when they want to get a new medication on the market.

These user fees currently fund about 50 per cent of Health Canada’s operating budget for regulating prescription drugs. Health Canada wants to increase that to 90 per cent. In addition, it will rebate 25 per cent of that fee if it fails to review new drug applications within an established period of time.

On the surface, charging companies for public services seems to make sense. After all, riders on public transit help pay for some of the costs.

However, there are significant differences. Transit riders are individuals with little power to influence the transit agency.

The Conversation

The same is not the case when it comes to drug companies and regulatory agencies. The Transportation Safety Board of Canada, which investigates accidents, is not funded by the companies that own the planes and trains. So why is there a different approach when it comes to drug companies and Health Canada?

As a former professor of health policy and a long-time pharmaceutical policy researcher, I would argue that these increased user fees in fact compromise Health Canada’s principal mandate: To protect the public’s health.

Prior to the introduction of user fees in 1994, Health Canada was solely funded by tax dollars. Its main relationship was to the public.

However, since the advent of user fees, Health Canada has a new funder: The pharmaceutical industry.

The public’s primary concern is to have safe and effective drugs. But the primary goal of the pharmaceutical industry is to get its products through the approval system as quickly as possible, and to sell those products to as wide an audience as possible.

Shortly after Health Canada introduced user fees, a senior official at the agency issued a memo in which he said: “The client is the direct recipient of your services. In many cases this is the person or company who pays for the service.” The one-page document focused on service to industry and relegated the public to the secondary status of “stakeholder” or “beneficiary.”

The introduction of user fees in Canada in 1994 was associated with a decrease in the time taken for drugs to get through the review process and onto the market. This means drugs now spend longer on the market under patent protection and produce more profits for drug companies.

Health Canada has explicitly denied any relationship between how quickly it reviews drugs and user fees. But a 1998 document clearly states: “Fee regulations would be amended to make this link [between fees and review performance] as soon as possible after the government determines the best way to proceed.”

Even though it’s often argued that faster drug approval is important to get new drugs to patients more rapidly, there is no evidence of a benefit to public health and considerable evidence of harm.

Most new drugs approved in Canada are no more effective and no safer than existing alternatives. Between 2010 and 2016, only 10.6 per cent of new patented drugs were classified as a substantial improvement or a breakthrough.

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