Independence under threat: the role of private actors in the setting of global pharmaceutical standards and resulting challenges for European public law

Abstract:

This article analyses the setting of global pharmaceutical standards in the International Council for Harmonization (ICH) and the implementation of these global standards in the European framework of pharmaceutical regulation. It thereby highlights the conflict between the publicprivate nature of the ICH process and the European administrative law principle of independence of public regulators.

While the ICH is a public-private partnership between regulatory authorities and pharmaceutical industry associations, in the regulation of pharmaceuticals in the European Union public regulators are subject to a strict requirement of independence from the industry they are regulating.

Nonetheless, the ICH standards are implemented into the regulatory framework for pharmaceuticals in the European Union, although the standard-setting process on the global level fundamentally contradicts the procedural standards of EU administrative law. In this regard, the article calls for a more coherent approach for the EU’s participation in global standard-setting bodies and the implementation of global standards in the EU.