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.

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.

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.