Health Canada's fast-track drug approval given partial welcome by Fraser Institute

A Canadian think-tank has welcomed the public dialog launched by the country's drug safety regulator, Health Canada, into the possibility of introducing a fast-track drug approval process. The Toronto, Canada-based Fraser Institute argues that quicker access will provide more benefits for patients by speeding up access to new products than it will increase the risk of unsafe drugs being "rushed" through the regulatory system.

Brett Skinner, the Institute's director of health, pharmaceutical and insurance policy research and author of the think-tank's study, Risk, Progressive Licensing and the Health Benefits Lost by Over-Regulating New Drugs, said: "part of the rationale used to justify pre-market regulation of drug safety is that the market is not as effective as government regulators." He added that "there are many reasons to believe that view is too extreme. For one, drug companies have a strong incentive not to misrepresent the safety of their products because doing so could damage their reputation in the market."

Health Canada's progressive licensing program would enable drugmakers to obtain fast-track pre-marketing approval of new medicines in exchange for greater post-marketing surveillance of drug safety. Although the scheme has the potential to speed up access to new medicines, Mr Skinner claimed it could also reduce access if it is pursued without considering the trade off between costs and benefits linked to excessive regulation of drug safety.