Panel 317: Risk Regulation, the EU Agencies and Institutional Innovation
Risk Regulation, the EU Agencies and Institutional Innovation
The mushrooming of EU agencies is one of the major changes in the EU regulatory governance of recent decades. The question that arises in this context is whether these EU bodies can be considered as proper solutions to fight against the substantial implementation deficit of EU law. In several cases the creation of agencies was seen as risk or even crisis management tool to address to challenges of the EU’s composite administration. However, the increase of the number of such bodies as well as of the competences conferred upon them does not necessarily mean that their role and status became undisputed regarding the Union’s institutional landscape. The panel is meant to present and discuss the most recent issues in this regard. It will focus on certain specific sectors such as environmental law and GMO regulation, the risk regulation of chemicals and the authorization of medicines while also targeting intersectoral issues such as the risk regulation and crisis management of gas supply and banking law.
Presentations of the Symposium
EMA, Risk Regulation and Accountability through Courts: The Case of Medicinal Products
Heavy reliance on expert advice is a long-standing feature of regulatory processes at European Union (EU) level – and a long-standing source of legitimacy challenges. Besides providing the regulator (i.e. the Commission) with reliable facts and knowledge, expert advice has historically played a significantly further-reaching role. The peculiarities of the EU executive, and primarily the contested nature of its democratic legitimacy, have often transformed expertise into a source of alternative, surrogate legitimacy for regulatory decision-making. Compensating a democratic legitimacy deficiency with technical legitimacy, has however resulted in a gap in terms of accountability, as traditional accountability mechanisms, both ex ante (political) and ex post (judicial) seem to have a limited bite on highly technical determinations. Legal accountability mechanisms, in particular, seem most unlikely to play any role in filling such gap, as Courts historically refrain from searching reviews of complex determinations.
Against this background, the paper focuses on measures adopted upon advice provided by the European Medicines Agency (EMA) in the context of marketing authorization for medicines. It first provides an overview of the structure, tasks, and functioning of EMA; it then considers the European Courts’ approach when reviewing medicines marketing authorisations based on EMA’s scientific advice. In so doing, it highlights a departure from the traditionally light standard of review adopted with regard to complex technical determinations, and argues that courts have started to interpret and apply EU constitutional principles (e.g. transparency, participation and rational administrative decision making) to tailor new mechanisms of legal accountability for expert-intensive regulatory decision making.
Towards Public Control of Scientific Studies? Revisiting Risk Assessment in the Glyphosate Era
The renewal of the authorization of the active substance glyphosate by the European Commission, following the scientific assessments by EFSA and ECHA and the positive vote of Member States’ representatives, has raised an unprecedented debate in the public sphere about the independence of studies on which the scientific opinions of EU agencies are based.
The European Parliament in its resolution of 24 October 2017 called on the Commission and the Member States to ensure that the scientific evaluation of pesticides for EU regulatory approval is based only on published peer-reviewed and independent studies commissioned by competent public authorities. Furthermore, the European Parliament supported the view that EFSA and ECHA should be granted sufficient resources in order to increase their capacity, so as to enable the commissioning of independent scientific studies.
Against this background, the proposed paper will address the question of public control over commissioned studies and which forms this control can take in order to achieve independence of expertise. These forms can vary from ordering the type of study which has to be conducted for an application dossier, to conducting audits in the used laboratories or even ordering the commission of studies funded by public money. It will be argued that relying on studies commissioned only by public authorities, as suggested by certain stakeholders, is not a panacea for safeguarding the independence of expertise, since also public research institutes or universities often receive funding by the industry and this need will increase, if they are to commission all studies needed by the industry. Furthermore, such a scenario does not take adequate account of the current reality in a globalized world and of the rights of the industry as well as of researchers working for private laboratories. It will, therefore, be argued that only a mixture of the different forms of public control may strike the right balance among the public interest and the rights of the companies and individuals involved. The possibility of ordering a publicly funded study may indeed be introduced in cases of conflicting results, especially for widely used substances.
Committees, EU Agencies and the Environmental Risk: The Case of GMOs
The governance of the EU environmental policy is characterised by the composite nature of its administration, which includes systems developed in the shadow of primary law such as committees and agencies. The institutional design of these systems affects the regulation and management of this field, especially in relation to risk regulation. At the same time, peculiar issues raised in this context (in particular, the regulation of genetically modified organisms, GMOs) have put into question the operation of these systems, resulting in a re-nationalisation of certain powers, and in a proposed amendment of the comitology regulation. Focusing on the specific case of GMOs, the paper will investigate the interplay between institutional arrangements and risk regulation in the environmental field, reflecting on their evolution in future perspective
Different but Similar Elements in Risk Regulation and Crisis Management of the EU's Banking and Gas Supply Law: Stress Testing, Cooperation Requirements and EU Agencies
The European Union’s Banking Union and the security of gas supply are clearly two policy areas, where the EU legislators had to face substantial risks, even Union-wide crisis situations in the last decades. In response, the legislator made clear steps to increase the EU-level capacity of risk analysis and crisis responsiveness. Sector-specific legislation enhanced the competences of already existing EU institutions, while created new EU-level bodies, which are specifically dedicated to address such risks and crisis situations. The paper is intended to demonstrate the potential areas, where sector-specific elements of the regulation might have an intersectoral impact, namely the stress testing, the cooperation requirements in crisis-management and the role of EU agencies.