The question of how best to tackle anthropogenic climate change is a thorny one: besides scientific uncertainty regarding the consequences of climate change, another difficulty is that the recommendations of climate experts may clash with the priorities of citizens, interest groups and political institutions. With the European Green Deal, the European Union (EU) recently made significant advances in climate policy; at the same time, and as is well known, the EU and its institutions have long been criticised for their “democratic deficit” and for their failure to involve all civil society actors equally in EU law-making processes. This article sheds light on the legal framework governing civil society participation in EU law-making, and more specifically on the Commission’s consultations pursuant to Article 11(3) of the Treaty on European Union. It then critically assesses selected features of two consultations conducted by the Commission in connection with the European Climate Law, which it evaluates from the perspective of the EU primary law principles of democracy, openness and transparency. Through this analysis, and by suggesting how future climate consultations could be further improved, the article aims to contribute to the (still nascent) legal scholarship on civil society participation in environmental and climate policy.

Stakeholder participation is an important tenet for European Union (EU) policymaking and it can be approached from different disciplinary angles. The legal literature tends to refer to participation as a formal consultative opportunity in regulatory processes, resulting in rather homogeneous institutional arrangements for participation across policy fields and different sets of problems. Sustainability science, on the other hand, starts from the understanding of a problem in its complexity and peculiarities as a driving force determining both the rationale behind and the design of each participatory process. In this paper, we explore lessons regarding participation that could be derived from adopting an approach in which we combine insights from law and sustainability science. Along four principles, we explore potential leverage points for improving the sustainability of EU decision-making processes and their outcomes.

Trilogues represent a decisive stage in the European Union (EU) legislative process and often settle the substantive content of EU legislation. During trilogues, negotiations move fast and new solutions are actively identified by the negotiators. The (lack of) transparency of trilogues has been repeatedly criticised in recent years, yet the EU institutions have defended their “space to think”. Relying on a set of interviews with trilogue participants, this paper mirrors the institutional practices in the final stages of EU law-making against the requirements of openness in the EU Treaties, which aim to strengthen “democracy by allowing citizens to scrutinize all the information which has formed the basis of a legislative act”. The paper argues that, despite noble proclamations, the EU’s legislative practices are characterised by institutional discretion and the lack enforcement of transparency requirements. The paper describes how trilogues are conducted and how questions involving risk management and technically complex issues are assessed in this process. Greater transparency would also help to ensure that risks and alternatives are properly assessed and would thus contribute to better-quality risk regulation in the EU.

The global climate crisis poses many risks; for instance, relating to the environment, to the economy and to public health. The mitigation and management of such risks create a complex and multifaceted regulatory conundrum that requires quick, flexible, efficient and adaptive policy solutions that transcend the state level. A quick look in the body of regulatory instruments employed in the field of climate change policy will reveal that soft law is used very frequently by the European Commission to aid with the application, transposition and interpretation of European Union (EU) environmental legislation relating to climate change. While soft law has become ever more prominent in the EU legal order and has been studied extensively at the ex-post phase (ie concerning its effects or effectiveness), little academic attention has been paid to the process of soft law-making. In simple terms, we know very little about how soft law instruments are made. This article peeks behind the scenes of soft law and examines the transparency and participation credentials of the articulation process of Commission Guidance Documents in the field of climate change regulation adopted under key legal acts in the field.

Responding to mistrust in the European agencies’ risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a fragmented legislative and administrative context, with each agency operating under a different legal framework. By focusing on authorisation procedures, from registration of studies to authorisation of novel foods, pesticides and human medicines, this article examines the resulting regimes governing the disclosure of scientific data by EU agencies to identify common trends and sectoral specificities. Against the background of an overall shift towards enhanced transparency, we shed light on, first, the circulation of institutional arrangements and practices among agencies and, second, the new dimensions of transparency emerging from these developments. We also highlight the remaining sectoral differences and argue that they could have potentially large impacts on the amount and type of information disclosed and on the level of transparency perceived by stakeholders and citizens. We argue that more coherence across the sectoral transparency regimes is needed, in particular in light of the agencies’ contested legitimacy and of their increasing cooperation on cross-cutting issues like antimicrobial resistance and medicine and pesticide residues in food.

What is the value of including vulnerable people in risk regulation decision-making in the European Union (EU)? This article examines a distinctive approach employed by the European Medicines Agency (EMA): public hearings integrated within safety reviews of medicinal products. The article presents findings from a case study of the EMA’s public hearing on Quinolone antibiotics, which was included by the EMA as part of a review process that led to significant tightening of regulatory restrictions on the prescribing of this class of antibiotics. The article argues that the public hearing enabled a group of patients who had been victims of a debilitating toxicity syndrome associated with Quinolone antibiotics to criticise the existing scientific evidence base around the safety of Quinolone. Deploying the quantitative Discourse Quality Index and an interpretive analytical approach, the article shows how patients challenged the evidence base in a manner that was efficacious in advancing knowledge in this area of risk regulation. When physically staged alongside interventions by professional experts, the article argues that patients facilitated a process of “negotiation” of expertise, leading professional representatives to propose methods of coordination in order to integrate the patients’ qualitative evidence of their suffering with the toxicity syndrome. Ultimately, this process led to the EMA proposing more stringent future guidelines for the prescription of Quinolone antibiotics in the EU.

In its evaluation cycle, the European Commission emphasises the importance of good data and the systematic involvement of a plurality of policy stakeholders, including citizens. Findings from European Union policy evaluation should inform further law-making, encourage learning and provide accountability. Transparent and inclusive formal procedures and tools are seen as essential for securing citizen participation in risk regulation; however, the Commission faces numerous challenges in securing engagement, particularly concerning the complexity of policy issues and the formal procedures for institutionalised consultations. Considering the Commission’s work from a proceduralist perspective, the article engages with Vivien Schmidt’s notion of “throughput legitimacy” to explore recent procedural innovations emerging since the Better Regulation agenda that have sought to enhance accountability, transparency, inclusiveness and openness, ensuring fairer and more balanced input on EU policy performance. The article argues in favour of greater throughput legitimacy in ex post policy evaluation but recognises challenges to the promotion of evaluation tools and their use by citizens.

The goal of our paper is to demonstrate the potential effects of a tax on paying a ransom on the incentives of stakeholders involved: both the perpetrators (the attackers placing the ransomware) as well as the potential victim. We do think that there is a case for a ransom tax, but we do also realise that it is not easy to make that case, and hence we express this doubt in our title. A tax could stimulate ex ante cybersecurity and also (when price elasticity is not too low) reduce ex post ransom payments. In addition, a tax in combination with a smartly designed subsidy could have benefits.

For the protection of biodiversity, the German Federal Environmental Agency (UBA) pursues the goal of establishing compensation areas to balance unavoidable indirect effects on nature and the environment caused by the application of plant protection products. Whether there is a legal basis for this within either European Union or national law is one of the most debated and pressing issues currently in the authorisation procedure for plant protection products in Germany. The purpose of this article is to provide a comprehensive legal assessment of whether it is legally permissible to make plant protection product authorisations contingent to compensatory application provisions to protect biodiversity.