Legitimising supranational risk regulation: the EU pharmaceutical and food safety regimes.

VerfasserKrapohl, Sebastian

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. Whereas EU pharmaceutical authorisation derives its legitimacy mainly from output factors, EU foodstuff regulation aims to strengthen input factors in order to regain legitimacy after the BSE scandal. Recent experiences suggest that this strategy in the foodstuff sector is not suitable for the restoration of consumer confidence. Thus, the article concludes that output legitimacy is more important for the day-to-day operation of supranational regulatory regimes than input legitimacy--a result which is more in line with Majone's (1996; 1998; 2001) concept of independent regulatory agencies than with Joerges' and Neyer's (1997; 2006) deliberative supranationalism.

2 Legitimising Factors of Supranational Risk Regulation

The potential legitimacy deficit of the EU has bothered the academic discussion to an immense degree over the last two decades (e.g. Horeth 1999; Rittberger 2004). Thereby, scholars widely disagree about the most important sources of legitimacy, about the existence or non-existence of a legitimacy deficit and about possible solutions. One range of scholars sees member states as the main source of legitimacy within the EU and concludes that a legitimacy deficit does not exist (e.g. Moravcsik 2002). Another view is that the EU suffers from a democratic deficit, because the EP is too weak and does not elect the executive (e.g. Crombez 2003; Follesdal/Hix 2006). A totally different position is held by Scharpf (1996a; 1999), who argues that the EU mainly suffers from a legitimacy deficit, because it leads to unbalanced policies. And finally, Majone (2000) argues that the EU suffers from a credibility crisis, because it lacks the necessary capacities to regulate the Single Market.

It is obvious that these four approaches are not compatible with each other, because they agree neither on the sources of, nor on the solutions to a legitimacy deficit. Whereas some share the view that legitimacy should be based on input factors, others agree that the EU's policy output is mainly responsible for its legitimacy. Whereas some assume that the member states are the only source of legitimacy, others assign the EU itself some capacity to provide legitimacy. The question to be explored in the following section is how all these different factors are able to contribute to the legitimacy of supranational risk regulation. Should EU regulatory regimes be legitimised by input from the member states or from the EP? Can supranational regulatory regimes derive legitimacy from their own policy outputs or do they have to rely on individual action of the member states? And finally, how are the different input and output factors related to each other?

2.1 Input Legitimacy: Member States, European Parliament and Stakeholders

The main argument for why the EU should rely on the member states as the most important source of legitimacy is that it lacks a demos which could justify majority rule (Scharpf 1999, 6-42; 2004; Weiler 1995). According to this view, majority rule is only regarded as legitimate if people share a common identity and some degree of solidarity. This allows them to accept the rule of a winning majority if they find themselves within a losing minority. However, the EU is not based on one European people, but on 27 different nations. Between these different peoples, the necessary solidarity for majority rule is deemed to be missing. Accordingly, the only way to legitimise EU policy-making is basing decisions on consensus of all member states. Qualified majority voting in the Council and participation of the EP increase the legitimacy deficit rather than reduce it. Majority rule in the Council allows that some member states can be overruled, and that citizens of these member states cannot hold their governments responsible for such decisions. And increasing influence of the EP even reinforces this problem, because the threshold for majority vote is even lower.

However, one may question whether majority rule is really that problematic in all circumstances. As long as the EU redistributes wealth between member states, the necessary solidarity between different states is indeed lacking. Such redistributions are zero-sum games, where some parties win what other parties loose, and the need for legitimacy is thus very high (Scharpf 2004). But most policies of the EU--and foremost all product regulations--do not resemble zero-sum games. Instead, harmonisations of product standards are usually coordination problems which have only second order distributive consequences. Here, all actors should have an interest in cooperative solutions in order not to lose efficiency gains of the Single Market. Thus, the need for legitimacy is much lower than for purely re-distributive policies (Majone 1996, 284-301). It is realistic to assume that actors accept relative losses in the short-run if cooperation meets their interests in the long-run. Only long-term cooperation needs to be legitimised by consensus between the member states, whereas single policies may be adopted by majority rule.

If the categorical necessity of unanimous rule is given up, intergovernmentalists lose their strongest argument against legitimisation of policy-making by the EP. As soon as majority rule becomes normatively acceptable, decision-making by the EP is ceteris paribus at least as legitimate as decision-making by the Council. The so-called legitimacy chain, i.e. the connection between citizens and decision-makers, is much shorter for the EP than for the Council. The former is directly elected by European citizens, and the legitimacy chain is thus relatively short. In contrast, the Council is only indirectly legitimised: citizens vote for their national parliaments, parliaments usually elect heads of governments, and governments send ministers to Council meetings. It is obvious that such a long legitimacy chain makes it extremely difficult to influence decision-making in the Council ex ante with national elections. As a result, one cannot see why the Council...

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