Joel Lexchin

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.

… 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.

… 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.

… Evidence of a poorer safety profile for drugs approved faster should serve as a warning against excessive pressure on reviewers exercising due diligence.