By Oliwia, Kaloyan and Carolin

The problem and regulatory framework

Pharmacovigilance produces near-constant scrutiny of medicines on the EU market. Yet in the years since the EU gave itself the power to fine companies for pharmacovigilance failures, that power has been formally triggered once, and no fine has followed.

The EU monitors the safety of authorised medicines continuously. Companies must track and report adverse events, national authorities inspect their systems, and the European Medicines Agency (EMA) assesses the safety of centrally authorised products on an ongoing basis. Set against that volume of routine oversight, one figure stands out: since Regulation (EC) No 658/2007, the Penalties Regulation, empowered the EU to impose financial penalties for such failures, it has produced a single infringement procedure, and that procedure closed without a fine.

Why so much monitoring but so little penalising? Part of the answer is that enforcement power is divided. A national authority may detect a problem, the EMA investigates it, but the decision on penalties is taken elsewhere, by the European Commission. When responsibility for an outcome is split this way, it can become unclear who is answerable for the result.

This post uses two distinct ideas to explain that. The first is responsibility in Dennis Thompson’s sense: ownership of an outcome, that is, whose conduct produced it. The second is accountability in Mark Bovens’s sense: the obligation of an actor to explain and justify its conduct to a forum that can question it and pass judgement. The argument is that when many hands produce an enforcement outcome, responsibility for the overall result becomes diffuse, and no forum is positioned to hold that overall result to account.

The framework itself is extensive. Directive 2001/83/EC sets out the general rules for medicinal products. For authorised medicines distributed within the EU, Regulation (EC) No 726/2004 establishes the EMA’s role and powers. The Clinical Trials Regulation and the EU’s pharmacovigilance rules add further safety and monitoring obligations. What determines whether these rules matter in practice is how they are applied.

Pharmacovigilance rules  –  the legal requirements and guidelines ensuring that medicines are monitored for safety, so that their benefits continue to outweigh their risks.

 

In practice, enforcement is divided between actors, each with a defined role:

• National authorities detect problems at Member State level
• The EMA investigates and assesses possible infringements
• The European Commission decides whether to impose penalties

The EMA is central to supervision and investigation, but it cannot impose fines. Although penalties can reach 5% of a company’s EU turnover for certain infringements, the power to impose them rests with the Commission. This leaves a gap between investigating a breach and deciding what follows from it. When enforcement is shared across institutions, establishing accountability becomes harder.

Comparative perspective

Other EU agencies are built differently. The European Securities and Markets Authority (ESMA) and the European Central Bank (ECB) can investigate breaches and impose penalties directly. ESMA can supervise specific market actors and adopt binding decisions, including financial penalties, without depending on another institution; the ECB supervises banks and sanctions breaches of EU banking rules. In those models, the body that builds the case also owns the outcome. The EMA model separates the two.

How Enforcement Works in Practice

One procedure, nineteen medicines, no fine

The first and, to date, the only infringement procedure opened under the Penalties Regulation tells us less about wrongdoing than about how the system divides authority.

 

80 000+ REPORTS LEFT UNASSESSED

~5 years FROM OPENING TO CLOSURE

€0 PENALTY IMPOSED

How it began

In 2012, a routine pharmacovigilance inspection by the UK’s MHRA, part of a coordinated European inspection programme, identified serious shortcomings in Roche’s pharmacovigilance system. Around 80,000 reports collected through a Roche-sponsored patient support programme in the United States had not been evaluated to determine whether they should have been reported to EU authorities as suspected adverse reactions. These included 15,161 reports of patient death. Whether the deaths had any causal link to the medicines was not known; under EU law the reports nonetheless had to be assessed, and they had not been.

The findings were referred to the European Commission, which asked the EMA to open a formal infringement procedure under the Penalties Regulation.

The procedure, step-by-step

2012	MHRA inspection identifies shortcomings. Some 80,000 unassessed reports found in Roche’s pharmacovigilance system. At the Commission’s request, the EMA opens an infringement procedure on 23 October 2012 under the Penalties Regulation.
2013	EMA finalises its benefit-risk safety review. No new safety concerns identified across the medicines concerned; this review is separate from, and without prejudice to, the infringement procedure. (EMA, 19 Nov 2013)
2014-2016	EMA builds the infringement case. Its initial report is finalised in April 2014 and passed to the Commission; the file returns to the EMA in 2015 for further inquiry; the EMA sends its final report to the Commission on 1 July 2016. The procedure concerns 19 centrally authorised products.
Dec 2017	Commission closes the procedure. Satisfied with Roche’s remedial actions, the Commission decides not to issue a statement of objections and closes the case. No fine is imposed. (Commission statement, 15 Dec 2017)

 

Who did what?

 

MHRA identified the problem

→

Commission asked EMA to act

→

EMA investigated

→

Commission decided the outcome

How to read the outcome

Enforcement did happen. Roche implemented remedial measures, the EMA produced a detailed record of the failures, and the safety review found no impact on the benefit-risk balance of the medicines. Closing a case once a company has remediated is a recognised regulatory approach. In EU competition law, the Commission can resolve non-cartel cases through a commitments procedure without imposing a penalty. On this reading, enforcement here corrected behaviour rather than punishing it.

But the division of roles has a cost for visibility. The institution that built the case had no formal say in how it ended. The Commission, which decided, published only a brief statement of its reasons, namely that it was satisfied with Roche’s remedial actions, rather than a detailed, reasoned account of why remediation was preferred to a penalty.

KEY OBSERVATION

The EMA carries the investigative burden; the Commission carries the decisional authority. The framework does not clearly require either institution to explain publicly how investigative findings translate into the final decision.

 

This design is deliberate. Under Regulation 658/2007, the EMA initiates and conducts the inquiry while the Commission takes the final decision. What the Roche case shows is not merely how one procedure unfolded, but how decisional power is distributed, and how that distribution affects whether responsibility for the outcome is visible.

What are the sanctions for?

Whether the absence of a fine is a problem depends on what a penalty is supposed to do. If its role were purely restorative (to repair an undesirable situation), then the outcome looks adequate: Roche overhauled its reporting systems, the outstanding reports were assessed, and the safety review found no effect on the benefit-risk balance of the medicines. The system was, in that narrow sense, repaired.

The harder questions concern the other functions. A penalty also has a deterrent and preventive role, signalling to every marketing authorisation holder that failing to assess tens of thousands of safety reports carries a real cost, and an expressive one, marking publicly that an obligation central to patient safety was breached. Remediation after the fact does little for either. This is why the accountability concern here does not depend on the claim that Roche deserved a fine. The concern is that a discretionary choice with system-wide signalling effects was made without a reasoned public justification. The problem is the unexplained exercise of discretion, not the absence of a penalty as such.

Who is responsible?

The Roche case exposes a recurring difficulty: when several institutions each follow their own rules correctly, yet the overall outcome is still open to question, it becomes unclear who bears responsibility for that outcome. This is the “problem of many hands.”

Dennis Thompson named the difficulty that arises wherever a task is divided among many actors:

“Because many different officials contribute in many ways to decisions and policies of government, it is difficult even in principle to identify who is morally responsible for political outcomes.” 

Dennis Thompson (1980), p.905

Many hands, or many eyes?

A reader might object that this is really a case of the “problem of many eyes” rather than many hands. Bovens draws both, and the distinction is worth stating precisely. Many hands describes the actor side: a forum faces several potential actors and cannot easily determine who contributed what, or who can be called to account. Many eyes describes the forum side: a single actor answers to many forums at once, each applying its own criteria. Many eyes is a problem of forum surplus (Bovens, “Public Accountability,” 2007, 182–208).

On the many-eyes reading, the accountable actor is Roche, facing a divided set of overseers: the MHRA, national authorities, the EMA and the Commission. That reading is coherent, but it answers a different question from the one this post asks. The concern here is not how Roche answers to its overseers; it is who owns the enforcement outcome, that is, the decision to close the case without a penalty or a reasoned justification. On that question the case fits the many-hands pattern: the MHRA, the EMA and the Commission each acted within their powers, yet responsibility for the combined result is not clearly attributable to any of them.

And it comes with a twist. Many eyes is a problem of too many forums; the difficulty here is the opposite. There is no forum at which the overall enforcement outcome must be justified. The case sits between the two: many hands on the actor side, and a forum gap, rather than a forum surplus, on the accountability side.

Applying this to EU pharmaceutical enforcement

In the Roche case, the EMA, the Commission and the MHRA each performed their role within their legal powers, and enforcement did take place: the failures were identified, investigated and remedied. But because the steps are carried out by different actors, no single institution oversees the process end to end. When the procedure closed without a fine and without a detailed public justification, it became difficult to identify who was responsible for that outcome. This is not the failure of any one institution but a feature of the system: responsibility is diffused across the stages of enforcement rather than attributable to a single actor.

Where responsibility sits, and where it does not

Political oversight does not generally focus on individual enforcement decisions, and where no formal sanction is imposed, judicial review may be unavailable, raising a concern under Article 47 of the Charter of Fundamental Rights, which guarantees the right to an effective remedy.

Accountability and design

On Bovens’s account, accountability is a relationship between an actor and a forum: the actor must explain and justify its conduct, the forum can question it and pass judgement, and the actor may face consequences. In the Roche procedure, there is no point at which the overall enforcement outcome must be justified in this way. Individual steps can be reviewed, but the combined result is not clearly subject to any single accountability forum. Accountability is missing precisely where responsibility is hardest to locate, which is how diffused responsibility (many hands) becomes an accountability gap.

Unlike the EMA, ESMA and the ECB can investigate and sanction directly, so the institution that builds the case also owns the outcome.

The issue, then, is not that enforcement is absent but that responsibility for it is not clearly visible. Addressing this need not mean redesigning the system. Granting the EMA limited sanctioning powers, on the ESMA model, would close the gap between investigation and outcome. Requiring the Commission to publish reasoned decisions when it closes such cases would make the exercise of its discretion visible to Parliament, courts and the public. As enforcement increasingly runs through shared structures, making responsibility visible is a precondition for accountability to function at all.

Europe is spending more on defence than ever, but rising budgets have not been matched by greater coordination. This blog post explores the economic rationale behind the EDA, its historical development, and how its role may need to evolve in today’s shifting geopolitical landscape.

By Martin, Alexandra, Gillis and Julia

While defence is and has always been a national responsibility of each European Union (EU) Member State, defence coordination and efficiency is now more important than ever. The European Defence Agency (EDA) was founded in 2004 to promote defence collaboration in the EU and to support integration within the EU’s Common Security and Defence Policy (CSDP) between Member States. Although defence spending has gone up in Member States, the collaborative procurement benchmark has consistently gone unmet, not because the EDA has failed as such, but because Member States have not made sufficient use of it for their joint procurement. The Agency can facilitate cooperation; it cannot compel it. This is why it has often been criticised for lacking teeth.

This blog post will therefore explore the economic reasoning of collaborative procurement behind the EDA and its historical development, after which the current geopolitical context will be analysed and how the EDA could and should react to this. This blog post argues that the EDA could be redesigned, by implementing several reforms and aligning its tasks with the current geopolitical context.

Spending More, Wasting Less

Europe is arming up. The EU’s 27 Member States spent €343 billion on defence in 2024 alone. But more money does not automatically buy more security. Part of the challenge is efficiency: turning each euro into more real military capability. Yet efficiency is only one side of the picture. European security depends at least as much on whether Member States are politically willing to use the capabilities they hold, as the response to Russia’s war in Ukraine has made clear. Even the best-equipped forces add little to collective security without the shared political will to deploy them. The EDA can help make spending more efficient, but it cannot manufacture that political will, which remains firmly with the Member States.

Efficiency can be achieved through quicker procurement, fewer duplicated national projects, and forces that can work together when it matters. That is the core economic argument for European defence cooperation. If Member States keep spending, buying, and developing in parallel, a great deal of that money risks being lost to fragmentation and inefficiency instead of being turned into usable collective strength.

At its core, the idea is straightforward, cooperation can help Member States to get more value from every Euro they spend. Defence equipment is extremely costly to research, produce, maintain, and upgrade. When each State follows its own path, defence orders stay small, due to limited national demand and technical standards that differ. Furthermore, national forces may end up utilizing systems that do not work well together within cross-border integrated forces. Economists describe this as a problem of fragmentation and the loss of economies of scale. In simple terms, the Member States individually, without coordinating their efforts, can end up paying more for less.

Defence can also be described as a special market. Governments do not buy ammunition, tanks or missile systems the way consumers buy groceries, phones or cars. National security concerns, political sensitivities, and domestic industrial interests often keep procurement focused and protected within national borders. This makes coordination harder, but also more necessary. The more procurement remains nationally fragmented, the greater the risk of duplication, incompatibility, and inefficient spending. The European Commission has repeatedly argued that a more integrated European defence market would support larger-scale production, stronger innovation, and more efficient procurement outcomes across borders.

Seen from this perspective, the economic rationale behind the EDA is not simply about “more Europe”. It is about reducing costs, overcoming coordination problems, and helping Member States turn rising defence budgets into stronger, more compatible, and more efficient capabilities.

The European Defence Agency

The EDA was established in 2004, at a time when European governments were becoming increasingly aware of a growing contradiction in their defence policies. On the one hand, security challenges were becoming more complex and often required collective responses. On the other hand, defence remained highly fragmented, with each Member State planning, spending, and procuring largely on its own.

This fragmentation was not a new problem, but it became more visible in the early 2000s. The EU’s experience in the Balkans during the 1990s exposed limitations in Europe’s ability to act cohesively in crisis situations. At the same time, global developments such as the September 11 attacks reinforced the need for more coordinated approaches to security and defence. European countries were also facing increasing pressure to do more with limited resources, while still maintaining a wide range of national military capabilities.

In light of these developments, the EDA was established to help address a key question: how can European countries cooperate more effectively in defence without giving up control over their own armed forces?

The Agency’s original legal basis was set out in a 2004 Joint Action under the EU’s Common Foreign and Security Policy. Its role was later formalised in the Treaty of Lisbon, where Article 45 of the Treaty on European Union defines its main tasks. These include identifying capability gaps, encouraging cooperation between Member States, supporting defence research and industry, and evaluating whether agreed commitments are being followed. Its current structure and functioning are further detailed in Council Decision (CFSP) 2015/1835.

Notably, the EDA was not designed as a powerful central authority. Instead, it was conceived as a facilitator, an institution that could bring Member States together, provide expertise, and promote cooperation, without overriding national sovereignty. In other words, it reflects a broader EU approach to defence: improving coordination rather than centralising control.

Academic observations highlight this balancing act. Some scholars argue that the EDA represents a pragmatic solution, allowing states to work more closely together while keeping ultimate authority at the national level. Others point out that this same design also limits its impact, as cooperation ultimately depends on whether Member States choose to follow through on shared priorities.

In this context, the creation of the EDA was less about transforming European defence overnight, and more about managing an existing tension: the need for collective action in a policy area that remains deeply tied to national sovereignty. This tension continues to shape both the Agency’s role and its limitations today.

A New Geopolitical Era

After Russia’s invasion of Ukraine, which led to ammunition shortages in the Ukraine and the EU, supply-chain pressure and wider uncertainty about European security, Member States have faced pressure to procure their military goods as quickly and efficiently as possible. The last years have however shown that this increase in urgency has not led to increased cooperation and that Member States still often value their sovereignty more than collectively procuring military goods. This may lead to duplication and over-reliance on non-EU suppliers.

This is also shown by the EDA’s collaborative procurement benchmark, set since 2007. As mentioned previously in this blog post, this benchmark has never been met. While the EU has estimated that the total EU defence expenditure has reached €381 billion in 2025, this increased spending has not been accompanied by a proportional increase in joint procurement among Member States.

An example of this is the French and German Future Combat Air System (FCAS), EU’s next generation fighter jet program, which aimed to improve the EU’s strategic autonomy and increase cooperation. While this could have been a great way to enlarge collaborative procurement among Member States, the FCAS has been described as potentially collapsed after Germany chose to purchase United States’ F-35 combat aircrafts instead of developing and procuring these via the FCAS-program.

The European Defence Agency 2.0

As described above, the geopolitical context in which the EDA operates has changed significantly since its establishment in 2004. Defence procurement has grown and become more urgent, but not necessarily more coordinated. While the industry grows, the economic inefficiencies, as described in section I, remain. This is where the redesigned role of the EDA comes in. By increasing coordination along the procurement chain, the EDA can address inefficiencies. Putting this into practice, requires structural rethinking the role of the EDA.

Any case for a stronger EDA has to be made against the institutional reality that the most supranational role in European defence is currently played not by the EDA but by the Commission. It is a question this section returns to below.

According to André Denk, EDA’s chief executive, the desire from Member States to do more on defence at EU level in line with the EU’s Defence Readiness 2030 programme, has increased. Denk introduced the redesigned role of the EDA in response to this call from Member States and the current turbulent geopolitical times. While the EDA’s traditional role remains, in essence, to coordinate rather than to centralise control, the amount of Member States in favour of expansion of the EDA’s mandate is rising. Denk called on Member States to: “use us to take forward the projects that one member state cannot.”

This call for a redesign of the EDA was also supported by former Estonian Prime Minister and current High Representative of the Union for Foreign Affairs and Security Policy, Kaja Kallas. Kallas made a statement on the inefficiencies in EU defence procurement. She spoke about the lack of complementary procurement, the focus on national interest, and persisting fragmentation. Kallas concluded that the EDA needs to lead, not just facilitate, thereby expressing her vision for a stronger EDA.

Coming back to the EDA’s core tasks, these were designed as open norms. The redesign therefore does not change the Agency’s architecture so much as the use Member States are prepared to make of it. As defence ministers increasingly speak with a sense of urgency, the space for the EDA to coordinate widens accordingly. In other words, a revised role for the EDA does not require a new agency; it requires Member States to make fuller use of the one they already have.

Two caveats follow from this. First, this is a willingness to procure together, which is not the same as a willingness to act together: even a Europe that buys efficiently and fields interoperable forces contributes little to its own security if Member States are unwilling to deploy what they own, as the halting response to Russia’s war in Ukraine has shown. A stronger EDA can close a capability gap; it cannot close a resolve gap. Second, the EDA is not the only candidate for that coordinating role.

The EDA proposed five revised lines of action:

1. Scaling up research;
2. Consolidating EDA’s central capability role;
3. Support joint procurement;
4. Secure resources;
5. Leveraging existing partnerships.

Apart from increasing budgets for already existing competences, the EDA’s goal is to take a more prominent role in the supply chain. In practice, this results in the EDA to target shared requirements for joint acquisition before contracts are put to market. This strategy can improve efficiency in concrete ways. When demand is aggregated earlier and common requirements are established at the EU level, Member States can benefit from larger production runs, reduced unit costs, and greater leverage with suppliers. Furthermore, existing partnerships with, for example, Ukraine, Turkey and Canada are to be strengthened under the EDA procurement framework. This redesigned EDA is stepping beyond pure facilitation and increasingly towards centralisation, answering the Member States’ calls.

Important to note is that the EDA operates within fixed structural limits. It does not control national defence budgets, cannot compel Member States to procure jointly, and works alongside existing frameworks such as NATO. Any case for a stronger EDA must also be placed in its wider institutional setting. In recent years, the most visibly supranational role in European defence has been played not by the EDA but by the European Commission. The Commission has increasingly shaped defence policy through funding and joint procurement instruments, from the European Defence Fund to more recent readiness and common procurement initiatives, despite the Treaties providing no defence specific legal basis for the Commission to do so. As Meershoek has shown, this expansion has been built largely on internal market and industrial policy competences rather than on any defence mandate proper, which makes the Commission’s authority in this field real but legally awkward. A more powerful EDA would therefore not be filling an empty space; it would have to be positioned alongside the Commission, raising a genuine question of institutional balance. Either way, the shift towards a modern, strategic EDA 2.0 depends not on institutional reform alone but on genuine political willingness among Member States to use the EDA for the projects that no single country can advance on its own and on clarifying how its mandate fits with the role the Commission has already assumed.

Coordination Is No Longer Enough

The EDA exists to help EU Member States coordinate and work together more effectively in defence: the idea is simply that cooperation can help countries avoid duplication and waste, save money, and build capabilities that work better together. But the EDA was never given strong powers of its own: it was designed to support and coordinate, not to force Member States to act. As this blog post has argued, the collaborative procurement benchmark has gone unmet not because the Agency has failed, but because Member States have not chosen to use it, and that has become harder to defend as spending rises fast while joint procurement remains limited. A stronger, more strategic EDA could help close this gap. Efficiency is not the same as security: even a well-funded, well-coordinated Europe adds little to its own defence if Member States lack the political will to use their capabilities when it counts. The EDA is not the only supranational actor in this space, the European Commission has increasingly driven European defence policy, so the real question is one of institutional balance rather than a simple case for a bigger EDA. A stronger EDA is therefore worth pursuing, but only if it is matched by genuine political will among Member States and by clarity about how its role fits alongside the Commission’s.

Enforcement of Single Market rules and ensuring a level playing field without unjustified barriers is key in order to make the Single Market work for businesses and citizens. In January 2026 the European Commission presented its first annual Single Market enforcement agenda as part of its annual Single Market and Competitiveness Report of 2026. Although, is it a fully-fledged agenda? The actual size and content of the agenda raise some questions. What does the Commission intend and how will it live up to its initial promises? Would a more comprehensive agenda be desirable and possible and how the Commission could and should give more transparency about enforcement? After a brief description of the initial announcement of the agenda and content of the first Single Market enforcement agenda, I will discuss the last two questions. More transparency is desirable: from a democratic perspective, but also in order to focus enforcement on those areas which matter most for a well-functioning Single Market based on a dialogue between the Commission, Council of Ministers of the European Union and European Parliament.

Continue reading “The Single Market Enforcement Agenda, an example of more transparency?”

Overtredingen van wetten en regels veroorzaken grote maatschappelijke schade: misbruik van zorggeld, schade aan het milieu en uitbuiting van werknemers. Maar de pakkans van ernstige overtredingen is laag. De Algemene Rekenkamer analyseerde 54 onderzoeken over toezicht en handhaving uit de periode 2013-2025. In de publicatie benoemt ze de vier grootste obstakels voor toezicht en handhaving en doet ze aanbevelingen.

Continue reading “[REPOST] Wat zijn de grootste obstakels in toezicht en handhaving?”

 Introduction

The liberalization of the energy market has introduced profound changes both to the structure and efficiency of energy supply, bringing the underpinnings of a competitive market with it.  At the same time, while open to the benefits of competition in some parts of the supply chain, the new energy market has become more prone to shock in relation to price fluctuations, its structure and assurance of demand. The 2021-2023 energy crisis has demonstrated the risks of a liberalized energy market in emergency circumstances, where as a result of unprecedentedly high energy prices, substantial number of energy suppliers became insolvent and were unable to supply the market sufficiently. In response to the crisis fall-out, the Commission proposed several structural tools to reduce risk of default among energy suppliers.

The aim of this blogpost is to highlight the potential role of existing EU insolvency and restructuring laws in mitigating energy supplier default and to explore whether their omission within the current regulatory policy is a missed opportunity for more effective enforcement.

Continue reading “Enforcement of insolvency and restructuring laws: a key to a competitive energy market?”

Data has become one of the most critical assets of the European digital economy. From artificial intelligence and platform markets to public services and industrial innovation, access to and sharing of data increasingly determine competitive dynamics, market entry, and the effectiveness of regulation. At the same time, data sharing raises complex legal questions: how to reconcile openness with the protection of personal data, trade secrets, and intellectual property; how to prevent data-driven market foreclosure; and how to ensure that regulatory interventions foster innovation rather than stifle it.

Over the past decade, the European Union has responded to these challenges with an increasingly dense—and at times fragmented—regulatory framework. The General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, and, more recently, the Data Governance Act (DGA), the Data Act (DA), and the Digital Markets Act (DMA) have profoundly reshaped the legal landscape. Together, these instruments signal a clear policy shift: data sharing is no longer merely encouraged, but in certain contexts actively mandated as a tool to promote competition, innovation, and fairness.

It is against this background that our recently published edited volume, Data Sharing Regulation in Europe (Routledge, 2025), aims to offer a systematic and enforcement-oriented analysis of the EU data-sharing regulatory landscape.

Continue reading “Data Sharing Regulation in Europe: Enforcement, Governance and the Future of the EU Data Economy (A new edited volume)”

Since 1887, (and arguably before that), the United States Congress has created regulatory agencies with a certain degree of independence from the President. The Supreme Court unanimously upheld that model as constitutional in 1935 and again in 1958, but the current Court began to chip away at it in the last two decades. The Trump Administration has now declined to defend independent agencies and the President has fired members appointed by Democratic Presidents. Now the issue is back at the Court and its conservative majority appears to be ready to overrule its precedents and declare many or most independent agencies unconstitutional. This would transfer more power to the Presidency, at Congress’s expense, at a time when many think that office has already become too powerful.

Continue reading “More Power to the President?  The U.S. Supreme Court is Poised to Restrict Congress’ Power to Create Independent Agencies”

In finance, trust is everything, but what happens when even our eyes and ears fail us? Recent cases show this is no longer a theoretical concern. Deepfake technology, powered by neural networks trained on massive datasets, can analyze audio, video, and images to produce highly realistic impersonations and edits, creating increasingly convincing fake media. This then could be used by fraudsters to commit crime. example, in one incident, a multinational corporation lost 25 million USD after fraudsters used deepfake video technology to impersonate its CFO during a live video call. In another, British energy executive wired funds after “speaking” with someone he thought was his CEO, only to later discover the voice was synthetic. Scenarios like these are now increasingly common. In a recent article, I co-authored with Dr. Michal Lavi, “Seeing is Believing? Deepfakes in Financial Markets,” we examine this emerging phenomenon, and suggest that more preventive enforcement strategy needs to be used to address this issue.

Continue reading “When Seeing Isn’t Believing: Deepfakes, Financial Markets, and the Limits of EU Enforcement”

*A conversation with Director Kross and Dr. Wessel Geursen

Earlier this year, one of the editors of eulawenforcement.com had the chance to discuss the interesting topic of the gestation of a competition authority and the challenges it faces in its first years of existence. This issue was at the core of the event ‘Competition law enforcement overseas: an interactive discussion with the Aruba Fair Trade Authority (AFTA)’, organized by the RENFORCE Building Block ‘Public Interest Ecosystems’ (PIE) at Utrecht Law School. In what follows below, we describe some of the main takeaways of our insightful conversation with the Director of the Aruban Fair Trade Authority (AFTA) Ernesto Kross and Dr. Wessel Geursen, a competition lawyer and specialist on the territorial scope of application of EU law.

Continue reading “The First Steps of the Aruban Fair Trade Authority as an Antitrust Enforcer”

In the intricate world of antitrust law, the definition of a relevant market stands as a cornerstone of competition analysis, yet its foundational assumptions are increasingly being questioned. This process, which identifies the boundaries of competition between firms, has traditionally relied on the model of a rational consumer. However, the growing body of knowledge in behavioral economics challenges this paradigm, a shift now formally acknowledged by regulators.

Continue reading “Mental Accounting and Market Definition in Antitrust: How Behavioral Biases Reshape Competitive Boundaries”