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.

EU Law, International Law and Economic Sanctions against Terrorism: The Judiciary in Distress? Research Papers in Law, 3/2008

From the Introduction. This article seeks to examine the relationship between European Union law, international law, and the protection of fundamental rights in the light of recent case law of the European Court of Justice (ECJ) and the Court of First Instance (CFI) relating to economic sanctions against individuals. On 3 September 2008, the ECJ delivered its long-awaited judgment in Kadi and Al Barakaat on appeal from the CFI.3 In its judgment under appeal,4 the CFI had held that the European Community (EC) is competent to adopt regulations imposing economic sanctions against private organisations in pursuance of UN Security Council (UNSC) Resolutions seeking to combat terrorism; that although the EC is not bound directly by the UN Charter, it is bound pursuant to the EC Treaty to respect international law and give effect to UNSC; and that the CFI has jurisdiction to examine the compatibility of EC regulations implementing UNSC resolutions with fundamental rights not as protected by the EC but as protected by jus cogens. On appeal, following the Opinion of Maduro AG, the ECJ rejected the CFI’s approach. It held that UNSC resolutions are binding only in international law. It subjected the contested regulations to full review under EC human rights standards and found them in breach of the right to a hearing, the right to judicial protection and the right to property. Kadi and Al Barakaat is the most important judgment ever delivered by the ECJ on the relationship between EC and international law and one of its most important judgments on fundamental rights. It is imbued by constitutional confidence, commitment to the rule of law but also some scepticism towards international law. In the meantime, the CFI has delivered a number of other judgments on anti-terrorist sanctions assessing the limits of the “emergency constitution” at European level. The purpose of this paper is to examine the above case law and explore the dilemmas and tensions facing the EU judiciary in seeking to define and protect the EU’s distinct constitutional space. It is divided as follows. It first looks at the judgment in Kadi. After a short presentation of the factual and legal background, it explores the question whether the EU has competence to adopt smart sanctions. It then examines whether the EU is bound by resolutions of the Security Council, whether the ECJ has jurisdiction to review Community measures implementing such resolutions and the applicable standard of judicial scrutiny. It analyses the contrasting views of the CFI, the Advocate General, and the ECJ taking account also of the case law of the European Court of Human Rights (ECtHR). Further, it explores the consequences of annulling the contested regulation. It then turns to discussing CFI case law in relation to sanctions lists drawn up not by the UN Security Council but by the EC. The paper concludes by welcoming the judgment of the ECJ. Whilst its reasoning on the issue of Community competence is questionable, once such competence is established, it is difficult to support the abrogation of Community standards for the protection of fundamental rights. Such standards should ensure procedural due process whilst recognising the importance of public security.

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.

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.

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

La disoccupazione giovanile in tempo di crisi: un monito all’Europa (continentale) per rifondare il diritto del lavoro? = Youth Unemployment in Recessionary Times: a Caveat to (Continental) Europe to Reconstruct its Labour Law. WP C.S.D.L.E. "Massimo D'Antona" .INT - 91/2012

The current debate taking place in continental Europe on the need to reform labour law to reduce the duality between labour market insiders and outsiders, thus giving new employment opportunities to young people seems to be, at its best, a consequence of the crisis, or at its worst, an excuse. The considerable emphasis placed on the power of legislation to reduce youth unemployment prevents real labour market problems from being clearly identified, thus reducing the scope to adopt more effective measures. Action is certainly required to help young people during the current crisis, yet interventions should not be exclusively directed towards increased flexibility and deregulation. This paper questions the “thaumaturgic power” wrongly attributed to legislative interventions and put forward a more holistic approach to solve the problem of youth employment, by focusing on the education systems, school-to-work transition and industrial relations. As a comparative analysis demonstrates, in order to effectively tackle the issue of youth employment, it is not enough to reform labour law. High quality education systems, apprenticeship schemes, efficient placement and employment services, cooperative industrial relations and flexible wage determination mechanisms are the key to success when it comes to youth employment, not only in times of recession.

Mass Surveillance of Personal Data by EU Member States and its Compatibility with EU Law. CEPS Liberty and Security in Europe No. 61, 6 November 2013

In the wake of the disclosures surrounding PRISM and other US surveillance programmes, this paper assesses the large-scale surveillance practices by a selection of EU member states: the UK, Sweden, France, Germany and the Netherlands. Given the large-scale nature of these practices, which represent a reconfiguration of traditional intelligence gathering, the paper contends that an analysis of European surveillance programmes cannot be reduced to a question of the balance between data protection versus national security, but has to be framed in terms of collective freedoms and democracy. It finds that four of the five EU member states selected for in-depth examination are engaging in some form of large-scale interception and surveillance of communication data, and identifies parallels and discrepancies between these programmes and the NSA-run operations. The paper argues that these programmes do not stand outside the realm of EU intervention but can be analysed from an EU law perspective via i) an understanding of national security in a democratic rule of law framework where fundamental human rights and judicial oversight constitute key norms; ii) the risks posed to the internal security of the Union as a whole as well as the privacy of EU citizens as data owners and iii) the potential spillover into the activities and responsibilities of EU agencies. The paper then presents a set of policy recommendations to the European Parliament.

The Criminalisation of Migration in Europe: A State-of-the-Art of the Academic Literature and Research. CEPS Liberty and Security in Europe No. 61, October 2013

In the last 30 years, a clear trend has come to define modern immigration law and policy. A set of seemingly disparate developments concerning the constant reinforcement of border controls, tightening of conditions of entry, expanding capacities for detention and deportation and the proliferation of criminal sanctions for migration offences, accompanied by an anxiety on the part of the press, public and political establishment regarding migrant criminality can now be seen to form a definitive shift in the European Union towards the so-called ‘criminalisation of migration’. This paper aims to provide an overview of the ‘state-of-the-art’ in the academic literature and EU research on criminalisation of migration in Europe. It analyses three key manifestations of the so-called ‘crimmigration’ trend: discursive criminalisation; the use of criminal law for migration management; and immigrant detention, focusing both on developments in domestic legislation of EU member states but also the increasing conflation of mobility, crime and security which has accompanied EU integration. By identifying the trends, synergies and gaps in the scholarly approaches dealing with the criminalisation of migration, the paper seeks to provide a framework for on-going research under Work Package 8 of the FIDUCIA project.

A Critique of Kosovo’s Internationalized Constitutional Court. EDAP 2014/02

The quality and the sustainability of the democratic institutions established in post-independence Kosovo under the guidance of the international community depend to a large extent on the performance of its constitutional court. The considerable international investment in that court reflects this assessment. One of the reasons why Kosovo’s international supervision has recently been terminated is that such court has been deemed to be functioning well. But its performance has not yet adequately been scrutinized. This essay reviews its most significant judgments, including decisions that deposed a president, annulled a presidential election, prevented a general election, and abolished the inviolability of parliament. The analysis of the reasons and effects of such rulings leads to the conclusion that the court gravely lacks independence and is subject to heavy political interference, which also the international judges do not seem immune from. The performance of the court is both a manifestation and a cause of Kosovo’s acute governance problems, which its international supervision has failed to remedy. The international community’s approach towards the court is also an illustration of the reasons why statebuilding in Kosovo led to unsatisfactory results, despite unprecedented investment.

Global Solutions, Local Damages: A Critical Study in Judicial Councils in Central and Eastern Europe. Research Paper in Law 07/2013

This article examines why, how, and with what results have judicial councils spread under the influence of European institutions throughout Central and Eastern Europe in the course of the last twenty years. It first traces back how the judicial councils, themselves just one possible form of administration of courts, have emerged as the recommended universal solution Europe-wide and internationally. Second, it discusses how has this model been exported under the patronage of European and international institutions to transition countries in Central and Eastern Europe. Assessing, thirdly, the reality of the functioning of such new judicial councils in these countries, in particular in Slovakia and Hungary, with the Czech Republic without a judicial council providing a counter-example, it is suggested that their impact on further judicial and legal transition has been either questionable or outright disastrous. This brings, eventually, into question the legitimacy as well as the bare reasonableness of the entire process of European/international standards setting and their later marketing or in reality rather imposition onto the countries in transition.

Disclosure of Leniency Materials: A Bridge between Public and Private Enforcement of Antitrust Law. Research Paper in Law 08/2013, December

The disclosure of leniency materials held by competition authorities has recently been under the spot. On the one hand, these documents could greatly help cartel victims to prove the damage and the causation link when filing damage actions against cartelists. On the other hand, future cartelists could be deterred from applying for leniency since damage actions could be brought as a result of the information submitted by themselves. Neither the current legislation nor the case law have attained yet to sufficiently clarify how to deal with this clash of interests. Our approach obviously attempts to strike a balance between both interests. But not only that. We see the current debate as a great opportunity to boost the private enforcement of antitrust law through the positive spillovers of leniency programmes. We hence propose to build a bridge between the public and the private enforcement by enabling a partial disclosure of the documents.