Vioxx. Rezulin. Seldane. Pondimin. Propulsid. These drugs were approved by government authorities, administered to patients and then withdrawn from the market because, in some cases, they killed.
they sometimes killed.
AZT. Propanolol. Interleukin-2. Timolo. These drugs took years to be approved by government authorities. They are now prescribed to patients whose lives they save, and they would have saved many more if they had been marketed earlier.
he question is how to regulate the supply of new prescription drugs. The human, social, health, economic and legal issues involved are as considerable as they are complex. More specifically, what should Canada do? Do we even need uniquely Canadian processes, when authorities in other countries, sometimes with far greater resources, are already carrying out lengthy and costly assessments?
The prescription drug approval process is an interesting case study in the development of a "smart" regulatory mechanism in Canada. In 2004, it received special attention from the External Advisory Committee on Smart Regulation set up by the Government of Canada.
While the scope and complexity of the issues at stake make the drug approval system a special case in itself, the analysis will be all the more substantial given that numerous studies have already documented certain shortcomings in the Canadian and U.S. systems. Moreover, there are sufficient similarities and differences between the two regimes to make a comparison meaningful. Finally, the integration between the two markets makes it possible to realistically envisage the type of scenario that will interest us here.
The goal is to save lives: everyone agrees. Manners are more controversial. Should we go faster, or more carefully? Should we control everything, or leave it to others? Basically, does the current regulatory framework for prescription drug approval achieve the objectives for which it was created? Many believe not, but for very different reasons: their diagnosis, and consequently the treatment they recommend, therefore varies considerably.
