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.

Law and Foreign Direct Investment. IES WORKING PAPER 4/2011

In this paper we examine the effect of law on foreign direct investment outflows with a specific interest in the relationship between international investment law and domestic private property laws. Our results indicate that FDI investor is indifferent to host country property rights, hence shareholder protection by law is not a significant determinant of FDI outflows. We argue that FDI, in contrast with other types of capital flows, can effectively mitigate the agency problem through majority ownership and control, hence reduce exposure to ex-post expropriation by the affiliate. On the other hand, FDI investor remains exposed to risk of expropriation by the host government and is strongly sensitive to the enforcement of law in the host country. In contrast with recent literature we conclude that there are no causal relationship between bilateral investment treaties and FDI.

The Regulatory Framework of Export Restrictions in WTO Law and Regional Free Trade Agreements. IES WORKING PAPER 8/2013

The use of export restrictions has become more and more common in recent years, evidencing the substantial loopholes existing in the WTO regulation on the matter. As a result of this deficient legal framework, the WTO membership experiences important losses of welfare and increasing political tensions. The multilateral negotiations for an updated discipline on export restrictions, in the context of the Doha Development Round, are blocked. Consequently, members have established a set of preferential bilateral and multilateral agreements to relieve the negative effects of these measures. Likewise, some recent WTO members have committed to stricter regulations as part of their Accession Protocols. Nevertheless, these methods have evidenced some important flaws, and the multilateral scene remains the optimum forum to address export restrictions. This Working Paper proposes a number of measures to improve the legal framework of the quantitative export restrictions and export duties, as well as their notification procedures.

Access to Electronic Data by Third-Country Law Enforcement Authorities, Challenges to EU Rule of Law and Fundamental Rights. Center for European Policy Studies, 2015

This study examines the challenges posed to European law by third country access to data held by private companies for the purposes of law enforcement. It pays particular attention to the implications for rule of law and fundamental rights of foreign authorities’ direct access to electronic information falling outside pre-established channels of supranational cooperation. A special focus is given to EU-US relations and the practical issues emerging in transatlantic relations covering mutual legal assistance and evidence gathering for law enforcement purposes in criminal proceedings.

EU-Turkey Summit on the refugee crisis Law and (dis)order? EPC Commentary, 21 March 2016

After many meetings and long hours of negotiations, the overwhelming feeling when a deal between the EU and Turkey was struck, was one of “mission accomplished”! Faced with an unprecedented crisis and forced to appease increasingly hostile public opinions back home, EU leaders had only one objective in mind: reducing the number of migrants arriving in the EU so that order can return in the framework of EU rules. However, a closer look at the Summit Conclusions and the EU-Turkey statement leaves a bitter taste, according to Yves Pascouau. In this Commentary, he questions the feasibility of the final EU-Turkey deal, saying that it creates more problems than it solves: besides the obvious legal and practical issues, it is far from certain which member states will be willing to do their part, or whether or not the EU can come up with a strategic vision on human mobility for the future.

An EU mechanism on Democracy, the Rule of Law and Fundamental Rights. CEPS Paper in Liberty and Security in Europe No. 91/April 2016 Thursday, 21 April 2016

The European Union is founded on a set of common principles of democracy, the rule of law, and fundamental rights, as enshrined in Article 2 of the Treaty on the European Union. Whereas future Member States are vetted for their compliance with these values before they accede to the Union, no similar method exists to supervise adherence to these foundational principles after accession. EU history proved that this ‘Copenhagen dilemma’ was far from theoretical. EU Member State governments’ adherence to foundational EU values cannot be taken for granted. Violations may happen in individual cases, or in a systemic way, which may go as far as overthrowing the rule of law. Against this background the European Parliament initiated a Legislative Own-Initiative Report on the establishment of an EU mechanism on democracy, the rule of law and fundamental rights and proposed among others a Scoreboard on the basis of common and objective indicators by which foundational values can be measured. This Research Paper assesses the need and possibilities for the establishment of an EU Scoreboard, as well as its related social, economic, legal and political ‘costs and benefits’.