EU risk regulation and its Global Standards: the case of Pharmaceuticals

The European Union in its risk regulation activities is increasingly relying on standards set by international entities. Using the example of standards for pharmaceutical products set by the International Conference for Harmonisation (ICH), this paper points out problems of transparency, participation and the use of expertise in standard-setting processes. It furthermore argues that regardless of the soft law nature of these standards, in fact the European Union without fail implements them into its risk regulation framework, where they receive ‘quasi-binding’ value regardless of the flaws in global process.