In October of last year, Health Canada proposed raising the fees it charges to drug manufacturers for new medicines introduced into the market. Historically, Health Canada has used these fees to fund 50% of its operating costs in regulating prescription medication, but plans to raise this to 90% with the coming fee increase. It also plans to provide a 24% rebate if it fails to review new drug applications within the accepted time frame.
Before user fees were introduced in 1994, Health Canada was entirely funded by tax dollars. Now, with the majority of its funding arising directly from the pharmaceutical industry, questions have been raised about whether or not the goal of drug companies to sell their products in vast quantities poses a conflict of interest with Health Canada’s responsibility to provide safe and effective drugs to Canadians.
While many argue that a faster process to review drugs allows the public earlier access to new medicines, there is no evidence that this pressurized approach benefits public health. In fact, most drugs newly approved in Canada are no safer or more effective than those already on the market; between 2010-2016, only 10.6% of newly patented drugs were identified as a substantial improvement or breakthrough when compared to what was already available to consumers.
In addition, faster review times for new drugs can impact the safety of the product. Typically, drugs reviewed within 300 days have a 20% chance of requiring new safety warnings, while this percentage rises to 33% when the review period is shortened to 180 days.
Additionally, instituting rigid review timelines for the sake of speed can impact public safety. In the USA, products approved within the FDA’s sixty day deadline are five times more likely to be withdrawn from the market due to safety concerns, and four times more likely to include serious safety warnings.
As pressure grows to meet regulation board deadlines, reviewers can miss or overlook safety concerns, which poses a great concern to critics of Health Canada’s decision to fund the majority of its regulation operating cost through the private pharmaceutical sector.