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

24 Pages Posted: 10 Apr 2012 Last revised: 6 Oct 2012

Date Written: January 29, 2012

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.

Keywords: International Conference on Harmonization (ICH), pharmaceutical marketing regulation, global standards

Suggested Citation

Dagron, Stéphanie, Global Harmonization Through Public-Private Partnership: The Case of Pharmaceuticals (January 29, 2012). IRPA GAL Working Paper No. 2/2012, Available at SSRN: https://ssrn.com/abstract=1995035 or http://dx.doi.org/10.2139/ssrn.1995035

Stéphanie Dagron (Contact Author)

affiliation not provided to SSRN ( email )

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