The Role of Domestic Administrative Law in the Accountability of Transnational Regulatory Networks: The Case of the ICH

Abstract

The literature on the accountability of transnational regulatory networks (TRNs) has focused on accountability measures that are available at the transnational level. This paper extends the analysis and examines the role domestic administrative law has to play in keeping TRNs accountable towards their internal and external stakeholders. To this end it conducts a case study of the International Conference on Harmonization (ICH), a network of drug regulatory authorities and industry associations that harmonizes drug registration rules, and examines it primarily from a U.S. administrative law perspective. The paper, first, demonstrates that domestic administrative law can have an important role in setting the procedural rules of TRNs. Second, it shows that domestic administrative law is important in maintaining the accountability of TRNs and regulators towards internal stakeholders (i.e. stakeholders within member countries), but that it has limitations that should ideally be complemented by accountability measures at the transnational level. The paper, third, demonstrates that although theoretically domestic administrative law could play an important role in setting off the TRNs’ disregard towards the interests of external stakeholders (stakeholders that are not network members), in practice this comes across serious problems. Accountability towards external stakeholders is, hence, best achieved through accountability measures at the transnational level.