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.

Rule of law or rule of thumb? A new Copenhagen mechanism for the EU. CEPS Policy Brief No. 303, 20 November 2013

This Policy Brief synthesises the main research findings and policy recommendations presented in the CEPS e-book entitled The Triangular Relationship between Fundamental Rights, Democracy and Rule of Law: Towards an EU Copenhagen Mechanism” (http://www.ceps.eu/book/triangular-relationship-between-fundamental-righ...). The authors examine the ways in which the European Union could strengthen and develop its competences in the assessment of member states’ fundamental rights, democracy and rule of law commitments. They argue that a strong political impetus is needed at Union level in order to set up a new supervisory “Copenhagen Mechanism” that would effectively and periodically evaluate member states’ compliance with democratic rule of law with fundamental rights on the basis of independent academic expertise, and by ensuring a high level of democratic accountability and judicial oversight at European levels. The Policy Brief also aims at summarising CEPS’ contribution to the upcoming Conference “Assises de la Justice: Shaping Justice Policies in Europe for the Years to Come” organised by the European Commission in Brussels on 21-22 November 2013.

The Impact of Visa Liberalisation in Eastern Partnership Countries, Russia and Turkey on Trans-Border Mobility. CEPS Liberty and Security in Europe No. 63, March 2014

Schengen Visa liberalisation in the Eastern Partnership countries, Russia and Turkey has proven to have a huge transformative potential across the justice, liberty and security policies of the countries where it has been deployed. Far-reaching technical reforms in the fields of document security, irregular migration and border management, public order security and fundamental rights have to be implemented so that visa-free travel can be allowed. Evidence provided by visa applications data reveals that visa liberalisation is a logical step, provided that the technical reforms are adopted and implemented. This study analyses the current state of play of the implementation of the EU visa policy instruments and assesses the positive impact of visa-free travel on trans-border mobility according to current visa application statistics.

EU-Turkey Relations: Turning vicious circles into virtuous ones. CEPS Policy Brief No. 317, 26 March 2014

The coming weeks and months will be decisive for the general tenor of politics in Turkey. The country faces local elections this March, presidential elections in August and general elections next June, while top-level political scandals compound the deterioration in the state of democracy and rule of law. At the same time, stagnation in Turkey’s accession process continues to sour relations with the EU. In this new Policy Brief, Steven Blockmans puts forward a number of recommendations to help drive the EU accession process forward, namely the early opening of negotiation chapters 23 (judiciary and fundamental rights) and 24 (justice, freedom and security), in line with the EU’s so-called New Approach. In that way reform could not just be assured on paper, but a track record in implementation could be established throughout the process. To achieve this, member states, and Cyprus in particular, need to be persuaded to end their opposition to formulating benchmarks for the opening of accession negotiating chapters 23 and 24.

A New Start for the EU’s Area of Freedom, Security and Justice? Setting of Priorities for the New European Commission. CEPS Commentary, 23 September 2014

The nomination of a First Vice-President (Frans Timmermans) in charge of rule of law and the EU Charter of Fundamental is one of the more far-reaching innovations contained in the new institutional shape of the Juncker Commission. This CEPS Commentary by Sergio Carrera and Elspeth Guild welcomes the fact that a new fundamental rights and rule of law First Vice-President will exercise a coordination and advisory role over the other two JHA Commissioners – Věra Jourová, responsible for Justice, Consumers and Gender Equality (DG Justice); and Dimitris Avramopoulos, responsible for Migration and Home Affairs (DG Home Affairs), but expresses a note caution whether this new role and triangular relationship can be made to work effectively in practice.

What can the Better Regulation Commissioner do for the EU? CEPS Commentary, 29 September 2014

This commentary welcomes the creation and prominence given by President Juncker to the new post of First Vice-President in charge of Better Regulation, Inter-Institutional Relations, the Rule of Law and the Charter of Fundamental Rights as among the most interesting of several novelties contained in the proposed Commission and overdue. After all, as the authors point out, better regulation has been underpinning the Commission’s core business, namely, EU regulation, for over a decade. At the same time, however, they warn that Commissioner-designate Frans Timmermans is receiving an extremely challenging mandate which pose many difficulties to overcome.

Freedom of religion in Turkey - The Alevi issue. EPC Commentary, 24 January 2014

Freedom of religion is a fundamental right that must be protected and respected by states. While Turkey has taken important steps in advancing religious freedoms over the last decade, a number of challenges remain. Turkey’s Alevi Community continues to face serious problems in terms of being officially recognised by the state and in practicing their religion. While Turkey is officially a secular country, Sunni Islam is the unofficial state religion. Despite Ankara being a signatory of several international conventions and treaties that guarantee fundamental freedoms for all, key fundamental rights of Alevis remain ignored by the state. Last September, hopes were raised that a new “democratisation package” would include steps to further their freedoms but it failed to do so, with the government announcing that a ‘special’ Alevi reform package would be unveiled by the end of 2013. This did not happen.

Turkey votes: Part II - Erdoğan reloaded. EPC Commentary, 3 April 2014

On 30 March, Turkey’s ruling Justice and Development Party (AKP) scooped a significant victory in local elections, taking almost 44 percent of the vote despite accusations of corruption, undermining the rule of law, fundamental rights and freedoms. While there have been claims of election fraud and the main opposition party, the Republican People’s Party (CHP), has demanded recounts in several cities including Istanbul and Ankara, it is clear that even allowing for some level of fraud the win was substantial and more than most people expected. Prime Minister Recep Tayyip Erdoğan has reached a juncture. He has two choices: return to the path of democracy after a period of democratic back-sliding which included passing several controversial reforms such as a new internet law which led to the recent banning of Twitter and Youtube; or alternatively he can forge ahead with his much talked of revenge campaign against those he has accused of creating a “parallel state” and conspiring to remove him from power. Given that Erdoğan viewed this election as a referendum on his popularity and leadership there is a serious risk that he will do the latter; using the significant mandate given to him to do whatever he wants, including further cracking down on democracy.

Migration and asylum: The movement of people in the Mediterranean Region - Future scenarios and the EU response. Jean Monnet Occasional Paper No. 11/2014

Introduction. In recent years, the global discussion on migration and asylum has evolved from polarization of perspectives and mistrust, to improving partnerships and fostering cooperation between countries and regions. The paradigm has shifted from control and security exclusively to an increased awareness of the ramifications of migration in development and labour markets, the increasing demographic gap1 and the dangers of exclusion faced by migrant workers (regular or irregular). Eastern Europe will suffer the biggest population decline in the coming years, and Nigeria’s population will reach one billion by 2100. In Europe, the work replacement ratio will be two pensioners for one active worker. It has become clear that these facts cannot be ignored and that there is a need for greater convergence of policies (migration/mobility, fundamental rights, and economic growth), with a migrant-centred approach.2. The assumption that Europe will remain a geopolitical and economic hub that attracts immigrants at all skill levels might not hold water in the long run. The evolving demographic and economic changes have made it evident that the competitiveness of the EU (Europe 2020 Strategy) is also at stake, particularly if an adaptable workforce with the necessary skills is not secured in view of shortfalls in skill levels and because of serious labour mismatches. Therefore, it is the right moment to develop more strategic and long-term migration policies that take into account the evolving position of Europe and its neighbours in the world. By the same token, labour market strategies that meet needs and promote integration of regular migrants are still a pending task for the Member States (MS) in terms of the free movement of people, but also in relation with neighbouring and partner countries.

Best Practices in Involuntary Loss of Nationality in the EU. CEPS Liberty and Security in Europe No. 73/November 2014

This paper was prepared as a ILEC Policy Brief for discussion at the final conference of the project on Involuntary Loss of European Citizenship: Exchanging Knowledge and Identifying Guidelines for Europe, 11-12 December 2014. Co-funded by the European Commission’s DG for Justice, Citizenship and Fundamental Rights, the ILEC project has aimed to establish a framework for debate on international norms on involuntary loss of nationality. For more information visit: www.ilecproject.eu.

European Citizenship at the Crossroads: Enhancing European Cooperation on Acquisition and Loss of Nationality. CEPS Liberty and Security in Europe No. 73/December 2014

This paper was prepared as a Policy Brief for discussion at the final conference of the project on Involuntary Loss of European Citizenship: Exchanging Knowledge and Identifying Guidelines for Europe, 11-12 December 2014. Co-funded by the European Commission’s DG for Justice, Citizenship and Fundamental Rights, the ILEC project has aimed to establish a framework for debate on international norms on involuntary loss of nationality. For more information visit: www.ilecproject.eu.

How to deal with quasi-loss of nationality situations? Learning from promising practices. CEPS Liberty and Security in Europe No. 71/December 2014

This paper was prepared as a Policy Brief for discussion at the final conference of the project on Involuntary Loss of European Citizenship: Exchanging Knowledge and Identifying Guidelines for Europe, 11-12 December 2014. Co-funded by the European Commission’s DG for Justice, Citizenship and Fundamental Rights, the ILEC project has aimed to establish a framework for debate on international norms on involuntary loss of nationality. For more information visit: www.ilecproject.eu.

Statistics on Loss of Nationality in the EU. CEPS Liberty and Security in Europe No. 70/December 2014

This paper was prepared as a Policy Brief for discussion at the final conference of the project on Involuntary Loss of European Citizenship: Exchanging Knowledge and Identifying Guidelines for Europe, 11-12 December 2014. Co-funded by the European Commission’s DG for Justice, Citizenship and Fundamental Rights, the ILEC project has aimed to establish a framework for debate on international norms on involuntary loss of nationality. For more information visit: www.ilecproject.eu.

British Balance of Competence Reviews, Part III: More reform than renegotiation or repatriation. EPIN [Working] Paper No. 42/December 2014. [see Abstract for I and II]

This paper, the third in a series for a CEPS project on the ‘The British Question’, is pegged on an ambitious exercise by the British government to review all the competences of the European Union on the basis of evidence submitted by independent stakeholders. The reviews considered in this paper cover the following EU policies: the single market for services, financial markets, the free movement of people, cohesion, energy, agriculture, fisheries, competition, social and employment policies, and fundamental rights. The declared objective of Prime Minister Cameron is to secure a ‘new settlement’ between the UK and the EU. From political speeches in the UK one can identify three different types of possible demand: reform of EU policies, renegotiation of the UK’s specific terms of membership, and repatriation of competences from the EU back to the member states. As most of the reviews are now complete, three points are becoming increasingly clear: i) The reform agenda – past, present or future - concerns virtually every branch of EU policy, including several cases reviewed here that are central to stated UK economic interests. The argument that the EU is ‘unreformable’ is shown to be a myth. ii) The highly sensitive cases of immigration from the EU and social policies may translate into requests for renegotiation of specific conditions for the UK, but further large-scale opt-outs, as in the case of the euro and justice and home affairs, are implausible. iii) While demands for repatriation of EU competences are voiced in general terms in public debate in the UK, no specific proposals emerge from the evidence as regards competences at the level at which they are identified in the treaties, and there is no chance of achieving consensus for such ideas among member states. Michael Emerson and Steven Blockmans, “British Balance of Competence Reviews, Part I: ‘Competences about right, so far’”, CEPS/EPIN Working Paper No. 35, October 2013 (www.ceps.eu/book/british-balance-competence-reviews-part-i-%E2%80%98competences-about-right-so-far%E2%80%99)(http://aei.pitt.edu/45599/); Michael Emerson, Steven Blockmans, Steve Peers and Michael Wriglesworth, “British Balance of Competence Reviews, Part II: Again, a huge contradiction between the evidence and Eurosceptic populism”, CEPS/EPIN Working Paper No. 40, June 2014 (www.ceps.eu/book/british-balance-competence-reviews-part-ii-again-huge-contradiction-between-evidence-and-eurosc)(http://aei.pitt.edu/52452/).

The European Council’s Guidelines for the Area of Freedom, Security and Justice 2020: Subverting the ‘Lisbonisation’ of Justice and Home Affairs? CEPS Essay No. 13, 14 July 2014

In its Conclusions of 26-27 June 2014, the European Council has adopted the new “Strategic Guidelines for Legislative and Operational Planning for the coming years within the EU’s Area of Freedom, Security and Justice (AFSJ)”. These Guidelines reveal a pre-Lisbon Treaty mindset among the EU member states and the Justice and Home Affairs Council. This essay argues that the Guidelines are mainly driven by the interests and agendas of national Ministries of Interior and Justice and are only “strategic” to the extent that they aim at first, re-injecting ‘intergovernmentalism’ or bringing back the old EU Third Pillar ways of working to the new EU institutional setting of the AFSJ and second, at sidelining the EU Charter of Fundamental Rights and rule of law in the AFSJ. The paper argues that the European Council Guidelines seek to prevent the advances in Justice and Home Affairs cooperation as envisaged in the Treaty of Lisbon, particularly its emphasis on supranational democratic, legal and judicial accountability. As a consequence of this move to ‘de-Lisbonise’ JHA cooperation, fundamental rights and rule of law-related initiatives will be neglected and the interest of the individual will be displaced from the centre of gravity in the coming AFSJ 2020 policy agenda.