The interplay of global standards and EU pharmaceutical regulation
Promovendus: Mw.Dr. S. Wirtz
Promotor: Mw. Prof.Dr. E.I.L. Vos
Duur: 1/9/2011 - 31/8/2014
Promotie: Maastricht, 18/12/2017
The European Union is increasingly relying on standards set by international entities in its risk regulation activities. Yet, global standard-setting in areas such as pharmaceuticals, foodstuffs and chemicals is problematic as it takes place in rather technocratic, obscure and closed setting by regulatory and industry which hides from public scrutiny. Global standard-setting by global standard setting entities is therefore subject to severe legitimacy concerns regarding quality and independence of the standard-setting process. The proposal will examine international standard-setting for pharmaceuticals, foodstuffs and chemicals on the conceptual basis of in- and output legitimacy and compatibility. It offers a systematic analysis of these bodies and their standard-setting as well as their impact on the EU so as to come to suggestions to improve the legitimacy of global standard-setting by international bodies.