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.

An Assessment of the Penalties System for Infringements of EU Competition Law: Can Personal Sanctions be the Missing Piece of the Puzzle? IES WORKING PAPER 6/2013

Competition law seeks to protect competition on the market as a means of enhancing consumer welfare and of ensuring an efficient allocation of resources. In order to be successful, therefore, competition authorities should be adequately equipped and have at their disposal all necessary enforcement tools. However, at the EU level the current enforcement system of competition rules allows only for the imposition of administrative fines by the European Commission to liable undertakings. The main objectives, in turn, of an enforcement policy based on financial penalties are two fold: to impose sanctions on infringing undertakings which reflect the seriousness of the violation, and to ensure that the risk of penalties will deter both the infringing undertakings (often referred to as 'specific deterrence') and other undertakings that may be considering anti-competitive activities from engaging in them (often referred to as 'general deterrence'). In all circumstances, it is important to ensure that pecuniary sanctions imposed on infringing undertakings are proportionate and not excessive. Although pecuniary sanctions against infringing undertakings are a crucial part of the arsenal needed to deter competition law violations, they may not be sufficient. One alternative option in that regard is the strategic use of sanctions against the individuals involved in, or responsible for, the infringements. Sanctions against individuals are documented to focus the minds of directors and employees to comply with competition rules as they themselves, in addition to the undertakings in which they are employed, are at risk of infringements. Individual criminal penalties, including custodial sanctions, have been in fact adopted by almost half of the EU Member States. This is a powerful tool but is also limited in scope and hard to implement in practice mostly due to the high standards of proof required and the political consensus that needs first to be built. Administrative sanctions for individuals, on the other hand, promise to deliver up to a certain extent the same beneficial results as criminal sanctions whilst at the same time their adoption is not likely to meet strong opposition and their implementation in practice can be both efficient and effective. Directors’ disqualification, in particular, provides a strong individual incentive for each member, or prospective member, of the Board as well as other senior executives, to take compliance with competition law seriously. It is a flexible and promising tool that if added to the arsenal of the European Commission could bring balance to the current sanctioning system and that, in turn, would in all likelihood make the enforcement of EU competition rules more effective. Therefore, it is submitted that a competition law regime in order to be effective should be able to deliver policy objectives through a variety of tools, not simply by imposing significant pecuniary sanctions to infringing undertakings. It is also clear that individual sanctions, mostly of an administrative nature, are likely to play an increasingly important role as they focus the minds of those in business who might otherwise be inclined to regard infringing the law as a matter of corporate risk rather than of personal risk. At the EU level, in particular, the adoption of directors’ disqualification promises to deliver more effective compliance and greater overall economic impact.

Current Challenges regarding the International Refugee Law, with focus on EU Policies and EU Co-operation with UNHCR. CEPS Paper on Liberty and Security in Europe No. 59, September 2013

From an examination of the instruments of the Common European Asylum System (CEAS) and related policy measures regarding border surveillance and migration management, two interrelated issues stand out as particularly sensitive: Access to asylum and responsibility for refugee protection. The prevailing view, supported by UNHCR and others, is that responsibility for the care of asylum seekers and the determination of their claims falls on the state within whose jurisdiction the claim is made. However, the possibility to shift that responsibility to another state through inter-state cooperation or unilateral mechanisms undertaken territorially as well as abroad has been a matter of great interest to EU Member States and institutions. Initiatives adopted so far challenge the prevailing view and have the potential to undermine compliance with international refugee and human rights law. This note reviews EU action in the field by reference to the relevant legal standards and best practices developed by UNHCR, focusing on the specific problems of climate refugees and access to international protection, evaluating the inconsistencies between the internal and external dimension of asylum policy. Some recommendations for the European Parliament are formulated at the end, including on action in relation to readmission agreements, Frontex engagement rules in maritime operations, Regional Protection Programmes, and resettlement.

Subsidiarity between Law and Economics. Research Papers in Law, 1/2005

From the Introduction. The present contribution is an attempt to raise awareness between the 'trenches' by juxtaposing the two approaches to subsidiarity. Subsequently, I shall set out why, in economics, subsidiarity is embraced as a key principle in the design and working of the Union and how a functional subsidiarity test can be derived from this thinking. Throughout the paper, a range of illustrations and examples is provided in an attempt to show the practical applicability of a subsidiarity test. This does not mean, of course, that the application of the test can automatically "solve" all debates on whether subsidiarity is (not) violated. What it does mean, however, is that a careful methodology can be a significant help to e.g. national parliaments and the Brussels circuit, in particular, to discourage careless politicisation as much as possible and to render assessments of subsidiarity comparable throughout the Union. The latter virtue should be of interest to national parliaments in cooperating, within just six weeks, about a common stance in the case of a suspected violation of the principle. The structure of the paper is as follows. Section 2 gives a flavour of very different approaches and appreciation of the subsidiarity principle in European law and in the economics of multi-tier government. Section 3 elaborates on the economics of multi-tier government as a special instance of cost / benefit analysis of (de)centralisation in the three public economic functions of any government system. This culminates in a five-steps subsidiarity test and a brief discussion about its proper and improper application. Section 4 applies the test in a non-technical fashion to a range of issues of the "efficiency function" (i.e. allocation and markets) of the EU. After showing that the functional logic of subsidiarity may require liberalisation to be accompanied by various degrees of centralisation, a number of fairly detailed illustrations of how to deal with subsidiarity in the EU is provided. One illustration is about how the subsidiarity logic is misused by protagonists (labour in the internal market). A slightly different but frequently encountered aspect consists in the refusal to recognize that the EU (that is, some form of centralisation) offers a better solution than 25 national ones. A third range of issues, where the functional logic of subsidiarity could be useful, emerges when the boundaries of national competences are shifting due to more intense cross-border flows and developments. Other subsections are devoted to Union public goods and to the question whether the subsidiarity test might trace instances of EU decentralisation: a partial or complete shift of a policy or regulation to Member States. The paper refrains from an analysis of the application of the subsidiarity test to the other two public functions, namely, equity and macro-economic stabilisation.2 Section 5 argues that the use of a well-developed methodology of a functional subsidiarity test would be most useful for the national parliaments and even more so for their cooperation in case of a suspected violation of subsidiarity. Section 6 concludes.

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.

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 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.

Current Problems of Social Europe. Research Papers in Law, 7/2007

From the Introduction. The main difficulty of Theology lies in the fact that the very existence of its subject-matter, God, may be put into question. Talking about Social Europe has something of a theological dimension. The aim of this article is to contribute into the debate, by putting into perspective some of the latest manifestations of social Europe. The need for the pursuance of social policies at the European level is now more pressing than ever (para 2). The EU, however, as it now stands, is the direct evolutionary result of the predominantly economic entity created back in 1957. This explains that the social policies pursued at the European level are piecemeal and often impregnated with market concerns (para. 3). From an instrumental point of view, EU social policy is being pursued concomitantly by secondary legislation (hard law) in the fields where the EU does have the relevant competences and by softer means of cooperation (soft law) in several other fields. Hard law has given the occasion to the European Court of Justice (ECJ), in a series of recent judgments, of putting to the fore the concept of a ‘social market’ (para. 4). Soft cooperation has been formalised into the infamous Lisbon Strategy and has been the main object of experimentation with the open method of coordination (OMC) (para. 5). The advances achieved in the above ways, however, do not offer firm answers to basic questions concerning the future development of the European social identity (para. 6)

The importance of International Developments in the case-law of the European Court of Justice: Kadi and the autonomy of the EC legal order. Research Papers in Law, 1/2009

From the Introduction. In the USA, the debate is still ongoing as to whether and to what extent the Supreme Court could or should refer to foreign precedent, in particular in relation to constitutional matters such as the death penalty.1 In the EU, in particular the recent Kadi case of 20082 has triggered much controversy,3 thereby highlighting the opposite angle to a similar discussion. The focus of attention in Europe is namely to what extent the European Court of Justice (hereafter “ECJ”) could lawfully and rightfully refuse to plainly ‘surrender’ or to subordinate the EC legal system to UN law and obligations when dealing with human rights issues. This question becomes all the more pertinent in view of the fact that in the past the ECJ has been rather receptive and constructive in forging interconnectivity between the EC legal order and international law developments. A bench mark in that respect was undoubtedly the Racke case of 1998,4 where the ECJ spelled out the necessity for the EC to respect international law with direct reference to a ruling of the International Court of Justice. This judgment which was rendered 10 years earlier than Kadi equally concerned EC/EU economic sanctions taken in implementation of UN Security Council Resolutions. A major question is therefore whether it is at all possible, and if so to determine how, to reconcile those apparently conflicting judgments.

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.

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.

Fundamental Rights of workers in the Digital Age: A methodological approach from a case study. WP C.S.D.L.E. "Massimo D'Antona" .INT - 89/2011

The relationship between employer and worker is not only obligatory but above all, as Sinzheimer said, a ‘relationship of power’. In the Digital Age this statement is confirmed by the massive introduction of ICT in most of the companies that increase, in practice, employer’s supervisory powers. This is a worrying issue for two reasons: on one hand, ICT emerge as a new way to weaken the effectiveness of fundamental rights and the right to dignity of workers; and, on the other hand, Spanish legal system does not offer appropriate solutions to ensure that efficacy. Moreover, in a scenario characterized by a hybridization of legal systems models –in which traditional hard law methods are combined with soft law and self regulation instruments–, the role of our case law has become very important in this issue. Nevertheless, despite the increase of judicialization undergone, solutions offered by Courts are so different that do not give enough legal certainty. Facing this situation, I suggest a methodological approach –using Alchourron and Bulygin’s normative systems theory and Alexy’s fundamental rights theory– which can open new spaces of decision to legal operators in order to solve properly these problems. This proposal can allow setting a policy that guarantees fundamental rights of workers, deepening their human freedom in companies from the Esping-Andersen’s de-commodification perspective. With this purpose, I examine electronic communications in the company as a case study.

Humanitarian Visas: Option or obligation?. CEPS Liberty and Security in Europe No. 68, 27 October 2014

Third-country nationals seeking protection have no EU-wide legal channels at present for entering EU territory and triggering protection mechanisms under the Common European Asylum System. As a result, many embark on hazardous journeys, with concomitant risks and loss of human life. The absence of ‘protection-sensitive’ mechanisms for accessing EU territory, along with EU external and extraterritorial border and migration management and control, undermine Member States' refugee and human rights obligations. Humanitarian visas may offer a remedy in this regard by enabling third-country nationals to apply in situ for entry to EU territory on humanitarian grounds or because of international obligations. This study asks whether the existing Visa Code actually obliges Member States to issue humanitarian visas. It also examines past implementation of humanitarian visa schemes by Member States and considers whether more could be done to encourage them to make use of existing provisions in EU law. Finally, with a Commission proposal for Visa Code reform on the table, it asks whether there is now an opportunity to lay down clear rules for humanitarian visa schemes.

2002 Parliamentary elections in Ukraine: Events, results and consequences; Ukraine's Parliamentary system after the elections. OSW Study 8/2003

2002 elections: On 31 March 2002, parliamentary elections were held in Ukraine. As expected, they were a major success for the centrist-rightist coalition focused around former Prime Minister Viktor Yuschenko. The communists emerged significantly weaker from the vote, and the "party of power" achieved a poor result. Yet, due to the mixed electoral law (half of the deputies were elected in single-mandate districts), the latter block, firmly supported by President Leonid Kuchma, resulted as the main force in Parliament. The results of particular parties and blocks were as follows: Viktor Yuschenko's Block received 23.57% of votes and 112 seats, the Communist Party of Ukraine - 19.98% of votes and 66 seats, the "For One Ukraine" block - 11.77% of votes and 101 seats, Yulia Tymoshenko's Block - 7.26% of votes and 22 seats, the Socialist Party of Ukraine - 6.87% of votes and 22 seats, and the Social Democratic Party of Ukraine (united) - 6.27% of votes and 24 seats. This shows how the mixed electoral regulations favour "For One Ukraine" and act against Yuschenko's block. One should note, however, that the latter gained the support of less than one quarter of voters. After the election: The dominant force in Ukraine's Verkhovna Rada, elected in March 2002, are the deputies of "One Ukraine", a fraction of the pro-presidential centre. "One Ukraine" has refused to admit any of the opposition's representatives (either from the right or left wings) into the parliament's presidium, but has accepted opposition-appointed heads of many parliamentary commissions. Viktor Yuschenko's "Our Ukraine", which has been the largest parliamentary fraction since June, attempted to proclaim itself the centre of the parliamentary majority, but its policy was awkward and inconsistent, and the main success of this club was that it didn't break up. Viktor Yuschenko's moves have been particularly incoherent and they undermined the image of Yuschenko as Ukraine's future leader, created throughout the course of the electoral campaign. In autumn, the main oligarchic groups and their representative fractions ("One Ukraine", which proved to be a useless instrument, was dissolved in June), reached a compromise with the president. It was agreed that the new prime minister should be a Donetsk clan representative (Viktor Yanukovych), and that the Dnipropetrovsk clan should appoint the president of the National Bank of Ukraine (this position went to Serhij Tihipko). The Kyiv clan obtained the President's Administration (Viktor Medvedchuk was appointed in spring) and a considerable number of parliamentary commissions. The president's interests in the government are to be protected by Mykola Azarov, former Head of the State Tax Administration. This compromise "package" was designed to secure the shares of the main oligarchic clans in the power and the president's strong position as mediator.