Who's calling the tune : Harmonization of drug regulation in Canada

Against this under US$1.1 billion and it employed 4,816 full- backdrop, the IFPMA took responsibility for or- time equivalents (FTE),1,2 compared to CAN$98 ganizing a series of trilateral meetings that lead million and 1,040 FTEs for Health Canada.3 The to the birth of the ICH in 1990.6 There are nota- EMEA coordinates the scientific evaluation of ble absences from the groups that are allowed appl [...] Risks development.”8 to public health, therefore, are likely to increase The mention of safety and the protection of [Emphasis in original].”6 public health in the ICH’s statement is the ra- The ICH has also taken a laissez faire attitude tionale that the regulatory agencies use to justify towards how quickly adverse reactions should be their participation. [...] An early example of Canadian harmoniza- tion, and an example of how industry’s economic priorities seemed to take precedence over Health Har moniz ation of Drug regul ations in C anaDa 7 Canada’s concerns with safety, was the push to sultations, where nearly all of the respondents shorten the time taken to approve the first phase opposed the 48-hour proposal, the TPP instead of clinical trials.14 [...] Despite this claim, in the Harmonization and smart regulation analysis of the benefits and costs to the various stakeholders, the first group to be considered The throne speech that opened the parliamen- was the pharmaceutical industry. [...] What the TPP tary session at the end of September 2002 enun- wanted to do was to create conditions that would ciated a new direction in Canadian regulatory lead to the increased development of the phar- activities that entailed “speed[ing] up the regu- maceutical industry in Canada, as illustrated by latory process for drug approvals to ensure that the following statement in the report: “A number