Legitimising Supranational Risk Regulation: The EU Pharmaceutical and Food Safety Regimes

1 Introduction: Input and Output vs. Input or Output Supranational risk regulation--i.e. the regulation of potentially dangerous products in the European Single Market--is problematic in respect to its democratic legitimacy for two reasons. Firstly, like all supranational policy-making, it could suffer from the EU's 'democratic deficit'. It is often argued that the EU lacks democratic legitimacy, because it is not well-enough controlled by a strong parliament (e.g. Follesdal/Hix 2006), it has a neo-liberal bias (Scharpf 1999) and it is too distant from its citizens, who do not constitute a European demos (Weiler 1995). If these arguments hold true, this would of course also affect the regulation of the Single Market by the Commission and various expert bodies. And secondly, supranational risk regulation is often even more detached from public scrutiny than other areas of EU policy-making. It usually takes place in technocratic bodies like expert and member state committees or regulatory agencies. These bodies are not democratically elected and are thus not directly responsible to EU citizens. Besides, their decision-making is often very intransparent or even takes place behind closed doors. Consequently, much criticism which is addressed to the EU in total might hold even truer for one of its core competencies--the regulation of the Single Market. As a result of these problems, it is important to ask which institutional mechanisms may strengthen the legitimacy of supranational risk regulation. Therefore, the following article is built on the distinction between input and output legitimacy as it has been repeatedly suggested by Scharpf (e.g. 1999; 2004). Accordingly, input legitimacy derives from 'government by the people', i.e. whenever citizens are able to articulate their will within policy-making. They may do so in national parliamentary elections, in the elections for the European Parliament (EP) or during stakeholder consultations. In contrast, output legitimacy results from 'government for the people', i.e. whenever policies meet the interests of concerned stakeholders. In order to ensure this kind of legitimacy, regulatory regimes should be accountable to various stakeholders for their decisions. As soon as supranational risk regulation is delegated to the Commission, various expert bodies or member state committees, policy-making becomes differentiated between legislation and single regulatory policies (Gehring 2005). In order to evaluate the legitimacy of supranational risk regulation, both levels of decision-making have to be analysed. It is not only important to consider how regulatory regimes operate, but also how the basic rules of decision-making were adopted. Thereby, the legitimising factors need not be the same on both levels. On the legislative level, the founding acts of regulatory regimes are adopted within the usual legislative procedures of the EU. Thus, they should be legitimised by the usual input factors like participation of member states' governments in the Council, involvement of the European Parliament (EP) and consultation of stakeholders. However, on the level of regulatory policies, input legitimacy becomes less important, the more political bodies are restricted by the rules adopted at the legislative level. Thus the importance of output legitimacy is necessarily increasing. In the following, this article explores the crucial relationship between input and output legitimacy of supranational risk regulation using the example of the EU regulatory regimes for pharmaceuticals and foodstuffs. It starts with operationalising variables which stand for high input and output legitimacy. Thereafter, the relationship between the two legitimising factors at both levels of supranational risk regulation is presented in more detail. The empirical part of the article analyses input and output legitimacy of the two supranational regimes for pharmaceuticals and foodstuffs. …