Harmony in Drug Regulation, but Who's Calling the Tune? An Examination of Regulatory Harmonization in Health Canada

Abstract

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.