The Europeanisation of Criminal Law and the Criminal Law Dimension of European Integration. Research Papers in Law, 3/2005

From the Introduction. In the academic year 1991-1992, Utrecht University, on my initiative, started to offer courses in European criminal law. This initiative came at a symbolic moment, just prior to the entry into force of the EU Treaty of Maastricht1 and the outlining of European policy in the areas of Justice and Home Affairs (JHA). The Director of the Legal Department, Paul DEMARET, was aware of the significance of this development and I have been given the opportunity to teach this subject at the College of Europe since 1995. Since then, JHA has evolved into one of the main areas of EU legislation. Now we are again on the threshold of an important historical feat. In June 2003, the European Convention reached agreement concerning a draft Treaty establishing a Constitution for Europe.2 The use of the term “Constitution” for the future EU Treaty is not simply cosmetic. The realisation has dawned that EU integration must be embedded in a treaty document which also regulates the rights and duties of citizens, not just with respect to European citizenship, but also with respect to, for example, Justice. Where JHA is concerned, this result acknowledges that the harmonisation of criminal law and criminal procedure and transnational cooperation cannot preclude the harmonisation of principles of due law and fair trial. Despite the substantial Europeanisation of criminal law, many criminal lawyers are defending the achievements and typicalities of their national criminal law like never before. EU initiatives are assessed from the perspective of the national agenda and national achievements. We are still too far removed from a European criminal law policy that is both European and enjoys national support. The core issue is therefore not how to keep our criminal (procedural) law national and free from European influences, but rather how to ensure democratic decision making, the quality of the constitutional state and the guarantees of criminal law in a national administrative model which has to operate increasingly interactively within a European and international context. In this contribution, the contours of the Europeanisation of criminal law are outlined and analysed. First, attention will be paid to the EC and, second, to the JHA. Following this, an evaluation and a look ahead at the current IGC are indicated.

European Criminal Law and General Principles of Union Law. Research Papers in Law, 5/2005

From the Introduction. The European Court of Justice, partly followed in this by the European legislator, has regulated Community law and policy through a set of general principles of law. For the Community legal order in the first pillar, general legal principles have developed from functional policy areas such as the internal market, the customs union, the monetary union, the common agricultural policy, the European competition policy, etc., which are of great importance for the quality and legitimacy of Community law. The principles in question are not so much general legal principles of an institutional character, such as the priority of Community law, direct effect or Community loyalty, but rather principles of law which shape the fundamental rights and basic rights of the citizen. I refer to the principle of legality, of nulla poena, the inviolability of the home, the nemo tenetur principle, due process, the rights of the defence, etc. Many of these legal principles have been elevated to primary Community law status by the European Court of Justice, often as a result of preliminary questions. Nevertheless, a considerable number of them have also been elaborated in the context of contentious proceedings before the Court of Justice, such as in the framework of European competition law and European public servants law.

Exploitative Abuses: Which Competition Policy, Which Public Policy? Research Papers in Law, 2/2007

As the final session of the day, my aim in this paper is to briefly outline the nature of exploitative abuses before turning to the question of the relationship between competition law and intellectual property law in the context of what Teubner calls the regulatory trilemma and from that draw a two-fold conclusion. First, the demands on law from the social phenomenon of markets are more acute when those demands raise issues across the different law domains of IP and competition. Second, where IP law and competition meet, the aim should be for both domains to internalise the values of the other. This however can only happen to the extent but only to the extent that there can be what Collins1 calls productive disintegration. Finally, in the specific context of exploitative abuses the overlap between IP law and competition law arises primarily in relation to claims of excessive pricing in licensing arrangements. Such claims could form the basis of a private action2 or can be made in the context of compulsory dealing decisions such as Microsoft.3 The involvement of competition agencies in pricing decisions goes to the heart of concerns about the nature of competition law and the role of competition agencies and highlights the need for the law to indirectly control rather than inappropriately attempt to directly control markets.

The EU essential facilities doctrine. Research Papers in Law, 6/2006

Introduction. The essential facilities doctrine may be seen as the ‘extra weight’ which is put onto the balance, in order to give precedence to the maintenance of competition over the complete contractual freedom of undertakings controlling an important and unique facility. The main purpose of the doctrine is to impose upon such ‘dominant’ undertakings the duty to negotiate and/or give access to the facility, against a reasonable fee, to other undertakings, which cannot pursue their own activity (and therefore will perish) without access to such a facility. This very simple description of the content of the doctrine underlines its limitations: through the imposition of a duty to negotiate or contractual obligations, the rule tends to compensate for the weaknesses of the competitive structure of a market, which are due to the existence of some essential facility. In other words, the doctrine does not by itself provide a definitive solution to the lack of competition, but tends to contractually maintain or even create some competition.1 The doctrine of essential facilities originates in the US antitrust case law of the Circuit and District Courts, but has never been officially acknowledged by the Supreme Court. It has been further developed and hotly debated by scholars in the US, both from a legal and from an economic viewpoint. In the EU, the essential facilities doctrine was openly introduced by the Commission during the early 1990s, but has received only limited and indirect support by the Court of First Instance (the CFI) and the European Court of Justice (the ECJ). It also indirectly inspired the legislation concerning the deregulation of traditional ‘natural’ monopolies. The judicial origin of the doctrine, combined with the hesitant application by the appeal courts, both in the US and the EU, cast uncertainty not only on the precise scope of the doctrine, but also on the issue of its very existence. These questions receive a particular light within the EU context, where the doctrine is called upon to play a different role from its US counterpart. In order to address the above issues, we will first pretend that an EU essential facility doctrine does indeed exist and we shall try to identify the scope and content thereof, through its main applications (Section 1). Subsequently, we will try to answer the question whether such a doctrine should exist at all in the EU (Section 2).

Saving the Monopsony: Exclusivity, Innovation and Market Power in the Media Sector. Research Papers in Law, 7/2006

From the Introduction. The Media Sector has experienced a technological revolution in the last 15 years. Digital encoding of television signals made possible a more efficient use of the radiospectrum. Digital terrestrial television (hereinafter, “DTT”) allows now for the reception of a significant number of free-to-air channels.1 Moreover, the use of new transmission platforms (hereinafter,“platforms”), namely cable and direct-to-home satellite (hereinafter, “DTH”) paved the way for the arrival in Europe of pay-TV operators, which finance their activities mainly via subscription fees. This changing technological landscape is subject to further evolution in the near future, as incumbent telecommunications operators become increasingly interested in making available broadcasting content2 as part of their broadband offer and 3G mobile handsets can be used for the reception of TV signals....The present paper seeks to ascertain whether the Commission “regulatory approach” towards the exclusive sale of premium content is a sound one, in particular in view of the constant technological evolution outlined above. The assumptions underlying landmark Commission decisions will be compared with recent developments of the media sector in Italy. In the NewsCorp./Telepiù case, decided in 2003, the Commission imposed very strict conditions to allow the merger giving birth to Sky Italia, on the assumption that the operation created a lasting near-monopsony in the different upstream markets for the acquisition of premium intervened against the media conglomerate Mediaset (which controls, inter alia, the main three private free-to-air channels in Italy) for an alleged abuse of dominant position.17 In fact, and contrary to the forecasts made by the Commission, Mediaset was in a position to acquire the broadcasting rights of the main Italian football teams, thereby excluding the incumbent (and near-monopolist) pay-TV operator, Sky Italia. This may go to show that the reality of the sector is more complex and evolves faster than one may infer from the Commission practice, thus putting into question its stance regarding exclusivity. The experience of the evolution of the Italian media sector will be used as the starting point for the evaluation of alternative regulatory options.

The Italian Merck Case. Research Papers in Law, 1/2007

From the Introduction. Regulation 1768/921 created supplementary protection certificates (hereinafter, ‘SPCs’) for medicinal products (hereinafter, “pharmaceuticals”) protected by patents. SPCs afford the same exclusive rights as those conferred by patents once these expire and may be granted for a maximum of five years.2 Italy enacted similar legislation in 1991, the most salient difference between both texts being that, pursuant to Law No. 349/91,3 holders of Italian patents for pharmaceuticals could be granted supplementary protection for a maximum period of 18 years after the expiration of the patent. Following the enactment of Regulation 1768/92, SPCs granted by the Italian authorities were brought in line with the period provided for in that text. However, pharmaceuticals for which supplementary protection was sought in the lapse between the adoption of Law No. 349/91 and Regulation 1768/92 (around 400 products) continued to enjoy the protection provided for in the former text.4 Several steps were taken by the Italian authorities to progressively reduce the length of protection granted to these products.

The AstraZeneca Case. Research Papers in Law, 4/2007

Introduction. On June 2005, after a five year investigation, the Commission imposed a 60 millions euros fine on AstraZeneca (hereinafter AZ) for having abused its dominant position in several Member States in the market for proton-pump inhibitors (PPI)2. It was alleged that AZ misused the patent system and procedures for marketing pharmaceuticals to block or delay the entry of generic competitors and parallel traders to its ulcer drug Losec3. This decision is a seminal one. The political and legal importance of the CFI judgment that will review the case (and the ECJ appeal that is likely to follow) cannot be understated. On the one hand the incentive to innovate and to undertake R&D is at stake, on the other, the uncertain boundaries between competition and intellectual property law should once again be explored. In contrast to the US, where many cases concerning the abuse of regulatory and governmental procedures have already been dealt with competition authorities and courts, it is the first time in Europe that such conduct is subject to scrutiny through an anti-trust lens. Moreover, following the appeal brought by AZ against the Commission decision, the CFI will be confronted for the first time with an abuse of a dominant position in the pharmaceutical sector, which explains why this judgment is eagerly anticipated4.

Legal Aspects in Establishing the Internal Market for services. Research Papers in Law, 6/2007

Introduction. The internal market for services is one of the objectives set by the founding fathers of the EC back in 1957. It is only in the last ten-fifteen years, however, that this aspect of the internal market has seriously attracted the attention of the EC legislature and judiciary.1 With the exception of some sector-specific directives dating back in the late ‘80s, it is only with the deregulation of network industries, the development of electronic communications and the spread of financial services, in the ‘90s that substantial bits of legislation got adopted in the field of services. Similarly, the European Court of Justice (ECJ, the Court) left the principles established in Van Binsbergen back in 1973, hibernate for a long time before fully applying them in Säger and constantly thereafter.2 Ever since, the Court’s case law in this field has grown so important that it has become the compulsory starting point for any study concerning the (horizontal) regulation of the internal market in services. The limits inherent to negative integration and to the casuistic approach pursued by judiciary decisions have prompted the need for a general legislative text to be adopted for services in the internal market. This text, however, hotly debated both at the political and at the legal level, has ended up in little more than a complex restatement of the Court’s case law. It may be, however, that this ‘little more’ is not that little. In view of the ever expanding application of the Treaty rules on services, promoted by the ECJ (para. 1),3 the Directive certainly appears to be a limited regulatory attempt (para. 2). This, however, does not mean that the Directive is a toothless, or useless regulatory instrument (conclusion: para. 3).

Environmental judgements by the Court of Justice and their duration. Research Papers in Law, 4/2008

From the Introduction. Little attention is paid, until now, to the duration of environmental procedures under Articles 226 and 228 EC Treaty, though these procedures are the only instrument at the disposal of the European Commission to enforce the application of EC environmental law1. Indeed, the Commission itself has no possibility to impose a fine or a penalty payment against a Member State, or to withhold sums under the Structural Funds, where a Member State persistently infringes Community environmental law. Rather, the Commission is obliged to first issue a Letter of Formal Notice against a Member State which infringes Community law. Where the infringement is not repaired, the Commission may issue a Reasoned Opinion against the Member State, and if also this does not lead to the compliance with EC law, it may appeal to the Court of Justice2.

Competition law proceedings before the European Commission and the right to a fair trial: no need for reform? Research Papers in Law, 5/2008

From the Introduction. This paper will thus show that, given the rapid "criminalisation" of competition law proceedings, sanctions should in principle be imposed at first instance I. Sanctions imposed by the Commission in competition proceedings are "criminal charges" within the meaning of Article 6 ECHR by an independent and impartial tribunal fulfilling all the conditions of Article 6 ECHR (part I). Or at the very least, these sanctions should be subject to full jurisdictional review by an independent and impartial tribunal in order to comply with Article 6 ECHR and to cure the defects of the administrative procedure (part II). It is doubtful however whether such a full jurisdictional review, as it is understood by the ECtHR, is available at Community-level in antitrust cases.

Public Procurement Law and Health care: From Theory to Practice. Research Paper in Law, 2/2010

From the Introduction. This contribution will focus on the core question if, how and to what extent the EU procurement rules and principles (may) affect the national health care systems. We start our analysis by summarizing the applicable EU public procurement legislation, principles and soft law and its exact scope in relation to health care. (section 2). Subsequently, we turn to the parties in a contract, subject to procurement rules in the field of health care, addressing both the definition of contracting authorities and relevant case law (section 3). This will then lead to an analysis of possible justifications for not holding a tender procedure in the field of health care (section 4). Finally, we illustrate the impact of EU public procurement rules on health care by analysing a Dutch case study, in which the question whether public hospitals in the Netherlands qualify as contracting authorities in terms of the Public Sector Directive stood central (section 5). Our conclusions will follow in section 6.

Patenting Strategies of the EU Pharmaceutical Industry -Crossroad between Patent Law and Competition Policy. Research Papers in Law, 1/2011

From the Introduction. The pharmaceutical sector inquiry carried out by the European Commission in 2008 provides a useful framework for assessing the relationship between the patent system on the one hand and competition policy and law on the other hand. The pharmaceutical market is not only specifically regulated. It is also influenced by the special characteristics of the patent system which enables pharmaceutical companies engaged in research activities to enter into additional arrangements to cope with the competitive pressures of early patent application and the delays in drug approval. Patents appear difficult to reconcile with the need for sufficient and adequate access to medicines, which is why competition expectations imposed on the pharmaceutical sector are very high. The patent system and competition law are interacting components of the market, into which they must both be integrated. This can result in competition law taking a very strict view on the pharmaceutical industry by establishing strict functional performance standards for the reliance on intellectual property rights protection granted by patent law. This is in particular because in this sector the potential welfare losses are not likely to be of only monetary nature. In brief, the more inefficiencies the patent system produces, the greater the risk of an expansive application of competition law in this field. The aim of the present study is to offer a critical and objective view on the use or abuse of patents and defensive strategies in the pharmaceutical industry. It shall also seek to establish whether patents as presently regulated offer an appropriate degree of protection of intellectual property held by the economic operators in the pharmaceutical sector and whether there is a need or, for that matter, scope for improvement. A useful starting point for the present study is provided by the pharmaceutical sector competition inquiry (hereafter “the sector inquiry”) carried out by the European Commission during the first half of 2008. On 8 July 2008, the Commission adopted its Final Report pursuant to Article 17 of Regulation 1/2003 EC, revealing a series of “antitrust shortcomings” that would require further investigation1.

In-house lawyers of NRAs may not represent their clients before the European Court of Justice: A case note on UKE (2011). Research Papers in Law, 3/2011

From the Introduction. It is not frequent for a National Regulation Authority (NRA) to bring an action against the Commission decision and, cynically speaking, case Prezes Urzędu Komunikacji Elektronicznej2 v Commission3 shows that the avoidance of a sweeping retaliation may be one of the reasons for it. The General Court followed the Commission‟s argument that, notwithstanding the peculiarities of the employment conditions of the Polish Regulator‟s legal counsel giving it virtually full independence, as well as the fact that the Polish law itself does not differentiate between in-house counsel and third party attorneys, the claim should be rejected on the grounds of inadmissibility. The GC based its judgment on Art 19 of the Statute of the Court of Justice4, which requires that, with the exception of the Member States' Governments and the EU Institutions, parties to the dispute must be represented by a lawyer. In so doing, the Court explicitly referred to the infamous Akzo Nobel Chemicals and Akcros Chemicals v Commission5 and EREF v Commission6. Most importantly, the Court stated that the lawyers representing Prezes Urzędu Komunikacji Elektronicznej (UKE) are bound to enjoy a degree of independence inferior to that of lawyers who are not linked to their clients by an employment contract7.

Legal privilege for in-house lawyers in the light of AKZO: a matter of law or policy? Research Papers in Law, 05/2011

From introduction. This paper discusses the arguments in favour of extending legal privilege to in-house lawyers in the light of the CJEU‟s judgement in AKZO. The previous jurisprudence is unambiguous, as the Court clearly stated in AM & S that the confidentiality of written communications between an undertaking and its lawyer is protected under Union law only when two cumulative conditions are fulfilled: they must be connected to the exercise of the client‟s rights of defence and the lawyer must be independent, that is, “not bound to the client by a relationship of employment”.1 This protection also applies to internal notes confined to reporting the content of communications with independent lawyers containing legal advice.2

Decentralisation of EC Competition Law Enforcement and General Principles of Community Law. Research Papers in Law, 4/2004

From the Introduction. By virtue of Council Regulation No. 1/2003, as of 1st May 2004 the full application of EC competition law will be entrusted to national competition authorities (hereinafter NCAs) and national courts. The bold reform of EC competition law enforcement adheres to the system of executive federalism1 which characterises the EC legal system. The repartition of competences within the Community allocates implementation of Community law mainly at Member States level. Pursuant to Article 10 EC, they are responsible for the implementation of the measures which have been adopted at Community level for the achievement of the objectives specified in the EC Treaty. Consequently, the attainment of the Community objectives depends very much upon the cooperation of national authorities, which act in accordance with their own national procedural rules.2 The various national procedural rules present themselves as conduits through which Community law is implemented and enforced. While as a rule Community law is not designed to alter national procedural rules, the Community legal order cannot afford to leave national procedural rules untouched when they are liable to hamper the effective application of Community law....For reason of space, this contribution intends only to highlight some aspects of Regulation No. 1/2003 with regard to which general principles of Community law are able to condition national procedural rules.