School of Health Policy and Management, York University, Toronto, ON, Canada.
Int J Health Serv. 2012;42(1):119-36. doi: 10.2190/HS.42.1k.
Harmonizing standards on drug regulation makes sense, but it must protect safety, ensure that only drugs that are truly effective are marketed, and protect a country's ability to act independently. The main driving force behind international harmonization is the International Conference on Harmonization (ICH). When it comes to safety, the ICH has been harmonizing to the lowest common denominator. Examples of harmonization indicate that industry priorities have influenced the direction that Health Canada has taken. Harmonization is also intimately tied in with the policy of smart regulation, changing regulations in a way that enhances the climate for investment. Canada has introduced user fees in concert with other countries, but there are concerns that these may compromise safety standards. When it comes to transparency, Health Canada has chosen to adopt the more restrictive European Union model rather than the more open process used by the United States. Finally, there are a number of areas in which Health Canada has chosen not to harmonize, and in each case the decision is in the direction of lower safety standards. Harmonization could be of benefit to Canada, but the evidence to date suggests that Health Canada been harmonizing down rather than up.
协调药品监管标准是合理的，但必须要保障安全，确保只有真正有效的药物才能上市，还要保障国家独立行动的能力。国际协调的主要推动力是国际人用药品注册技术协调会（ICH）。在安全性方面，ICH 一直都在协调到最低标准。协调的例子表明，行业的重点已经影响了加拿大卫生部的方向。协调还与智能监管政策密切相关，以增强投资环境的方式来改变法规。加拿大与其他国家一起引入了用户收费，但有人担心这可能会影响安全标准。在透明度方面，加拿大卫生部选择采用更严格的欧盟模式，而不是美国采用的更开放的程序。最后，加拿大卫生部在一些领域选择不进行协调，在每一种情况下，决策都是朝着降低安全标准的方向进行的。协调对加拿大可能有益，但迄今为止的证据表明，加拿大卫生部一直在协调降低标准，而不是提高标准。
