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.

Towards a New (European Research) Deal: The Case for Enhanced Fiscal Policy Coordination on Research and Innovation. Bruges European Economic Policy (BEEP) Briefing 20/2008

The paper reviews the evolution of research and innovation in the EU and assesses how current policies and programmes have influenced the development of Europe's research landscape. Based on existing literature, evaluation reports and practice, the paper critically examines the effectiveness of current European research funding instruments in a context of open innovation and in the presence of global spillovers. It therefore develops a subsidiarity test to assess whether current rationales still prove sufficient to justify policy intervention in this area. The paper sheds light on how to improve the effectiveness of EU action by enriching it by the use of coordinated fiscal policy for research funding. This will constitute an incentive to genuine bottom-up research, development and innovation (R&D&I) and a stimulus to local investments in innovation. The paper also assesses the potentials of a reinforced open method of coordination as well as a review of state aid law in the field of research funding in the EU.

The autonomy of the EU legal order and the law-making activities of international organizations. Some examples regarding the Council most recent practice. Research Papers in Law 03/2012

[Introduction.] It is generally believed that while the principle of the autonomy of the EU legal order, in the sense of constitutional and institutional autonomy that is to say what concerns the autonomous decision-making of the EU, has been clearly strengthened by the most recent jurisprudence of the Court of Justice (eg. Moxplant3, Intertanko or the Kadi/Al Baraakat judgements or the Opinion 1/2009 of the CJEU etc.) as well as, in my opinion, in many aspects by the Treaty of Lisbon, it is still valid to add that the principle of a favourable approach, stemming from the Court jurisprudence, for the enhanced openness of the EU legal order to international law has remained equally important for the EU4. On the other hand, it should be also seen that in a globalized world, and following the increased role of the EU as an international actor, its indispensable and crucial role concerning the creation of world (legal) order in many policy fields ( for example let's think about the G20 issues, the global economic and financial crisis, the role of the EU in promoting and protecting human rights worldwide, the implementation of the multilateral or regional conventional law, developed in the framework the UN (e.g. in the field of agriculture or environment etc) or what concerns the Kyoto process on climate change or the conservation of marine biological resources at international level etc), it seems reasonable and justified to submit that the influence, for example, of the law-making activities of the main stakeholder international organizations in the mentioned policy-areas on the EU (especially on the development of its constantly evolving legal order) or vice-versa the influence of the EU law-making practice on these international organizations is significant, in many aspects mutually interdependent and more and more remarkable. This tendency of the 21st century doesn't mean, however, in my view, that the notion of the autonomy of the EU legal order would have been weakened by this increasing interaction between international law and EU law over the passed years. This contribution is going to demonstrate and prove these departuring points by giving some concrete examples from the most recent practice of the Council (all occuring either in the second half of 2009 or after the entry into force of the Lisbon Treaty), and which relate to two very important policy areas in the EU, namely the protection of human rights and the Common Fishery Policy.

La justification des atteintes aux libertés de circulation : cadre méthodologique et spécificités matérielles = Justification of attacks on freedom of movement: methodological framework and specific hardware. Research Paper in Law 01/2013

No abstract.

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.

From Structure to Substance: Has the Constitutional Treaty improved the Chances for a Common Foreign and Security Policy? Research Papers in Law, 6/2005

From the Introduction. A common foreign and security policy for the European Union is an issue of the day. While most academic and many political observers believe that it would be in the interest of the Union to have a common policy, there is quite some disagreement as to how this is to be achieved and whether it should be accomplished in an assured and regular manner or whether it should come about on an ad hoc basis only when it is in the clear interest of all member states at any particular time. In other words, is a common foreign policy to be a fundamental characteristic of the Union or is it to be an occasional occurrence when advantageous and convenient, the ‘C’ in CFSP – as one observer has sarcastically commented – standing not for ‘Common’ but for ‘Convenient’?2

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.

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.