Global Harmonization Through Public-Private Partnership: The Case of Pharmaceuticals

Abstract

The harmonization activities of the International Conference on Harmonization (ICH) in the field of pharmaceutical marketing regulation perfectly illustrate the possible normative influence of non-binding instruments adopted by sub-national actors. The ICH is a hybrid organization composed of representatives of the pharmaceutical industry on one hand and the national regulation agencies of three regions on the other. An intergovernmental organization, the World Health Organization (WHO), is associated to the ICH activities through its observer status. The ICH has adopted more than 50 “technical” guidelines which have developed into global standards. It has thus become extremely difficult for national regulators to modify the criteria for drug marketing approval unilaterally. Some guidelines go beyond the standardization of technical requirements. They reflect commercial, political or ethical choices and pose complex legitimacy and accountability challenges. The analysis of the multi-level procedure and institutional framework of the ICH has so far not been conducted from a global administrative law perspective. A closer examination of the ICH process reveals a deficient structure and the need for the development of new legal standards. Some steps already taken by the ICH should be pursued further and could contribute a model for greater accountability and legitimacy for new forms of global administrative decision-making procedures.