Legal protection of biotechnological inventions. The European Parliament's perspective]

In 1996, the European Commission put forward a proposal for a Parliament and Concil Directive on the legal protection of biotechnology inventions. The article looks at vicissitudes which characterised the progress of the proposal in the Council and the European Parliament. The future directive will regulate the patentability of biological material, which is a particularly sensitive issue when the material is of human origin. The article also seeks to set the proposed directive in a wider context by referring to forthcoming international Convention Law on biotechnology and to the legal situation in Spain at present.     

The Patients’ Rights Directive (2011/24/EU) – Providing (some) rights to EU residents seeking healthcare in other Member States

This article presents the main elements of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, commonly known as the Patient’s Rights Directive. It is the latest EU initiative with regard to European Health Care and the Single Market. The main elements of the Directive contain provisions related to the prior authorisation of health care in another Member State, the reimbursement of such health care and the removal of unjustified obstacles to achieving these aims.These provisions largely reflect the recent case law of the European Court of the Justice (ECJ). Amongst these are provisions involving the use of personal data. Such provisions will engage data protection issues and will have to be carried out according to the data protection directives. Alongside this primary aim of codifying ECJ case law the Patient’s Rights Directive also introduces novel initiatives aimed at fostering cross border cooperation between various elements of national healthcare systems.Part 1 of this contribution will describe the legal basis and the aims of the PRD, Part 2 will describe the principle obligations placed on the Member States with regard to reimbursement, Parts 3 and 4 will describe other informational and procedural requirements placed upon the Member States of Treatment and Affiliation. Finally Part 5 will outline some of the novel initiatives that have been included in the PRD.The increases in the frequency of cross border-treatment that this directive attempts to facilitate are likely to see a concurrent increase in cross-border patient information flows. Such data flows will be subject to the Union’s provisions on Data Protection. It remains uncertain whether the EU’s Data Protection regime will act as inhibitor to cross-border medical treatment or rather represent a gold standard that allows patients to engage in such activities with peace of mind. The Patient’s Rights Directive will form part of the EU’s future e-Health strategy which envisages a large increase in the fluidity of patient data. A discussion of this directive is therefore merited in this journal.     

Rethinking Product Liability: A Missing Element in the European Commission's Third Review of the European Product Liability Directive

The paper uses the opportunity afforded by the European Commission's Third Report of the Product Liability Directive to assess the present state of product liability in Europe. It notes that despite the maximal harmonisation character of the Directive there is a risk of divergence between Member States on key issues including the core concept of defectiveness. The Commission seems at times confused (for example, as regards the relationship between defect and fault liability) and more often complacent about the risks of divergence; but this sits uneasily with the espousal of maximal harmonisation. Ultimately there may be a need for a rethinking of product liability to ensure greater clarity as regards the underlying rationale supporting strict liability. This seems unlikely to materialise in the near future and so at the very least the Commission should act to clarify some core concepts that are proving difficult to interpret for the courts.     

Patent Protection in Europe: Integrating Europe into the Community or the Community into Europe?

Patent protection in Europe basically rests on two pillars: national grants or grants from the European Patent Organisation (EPO). The EPO grants patents by a centralised procedure with uniform conditions, but once granted the patents become national and subject to the divergent national laws of EPO–Member States. The system has been very successful, so successful, indeed, that it overshadowed the Community's many unsuccessful attempts to set up a Community patent system of its own by way of a convention between Member States. As the Commission has recently stepped in by proposing the establishment of a Community Patent system by way of regulation, a kind of 'cooperative rivalry' has arisen between the Community and the EPO about how to unify patent protection in Europe. This rivalry not only mirrors divergent views on the politico–economic functions of the patent system, but also is illustrative of different concepts of regional integration in a context of global competition for innovation.     

National Support for Film Production in the EU: An Analysis of the Commission Decision‐Making Practice

This article deals with the cultural welfare concerning cinema, a medium capable of both painting and shaping society. It aims to investigate the impact of the European integration on national film promotional law, by studying the European Commission decision‐making practice in the field of State aid to cinematographic works. The analysis shows that this practice can be understood in two main phases that are delineated by the adoption of specific criteria. These criteria are explored by highlighting the most elucidating cases. Furthermore, this analysis discloses two relevant conflicts: within the Commission itself and between the Commission and the Member States. Particular emphasis is placed on the latter, which is explored with regard to: the European national film agencies' polarisation of the conflict, the main form of dispute settlement adopted by the Commission, and the legal obligations imposed by Member States upon TV broadcasters to invest in audiovisual 1 production. The analysis ends with an evaluation of the above‐mentioned impact and a few remarks on some unresolved issues related to the conflict between the Commission and the Member States.     

Public procurement as a means to achieving social gains – progress and challenges in European legislation and standards for accessible information and communication technology

This article explores the European Commission goal of improving the quality and level of accessibility in mainstream information and communication technology (ICT) goods and services available in Member States through the use of public procurement legislation and performance standards. Over the past two decades, the Commission has encouraged Member States to adopt common requirements for accessibility and to strengthen efforts to use these requirements in public procurement. In the absence of significant improvements in the level of accessibility over this time, the Commission has more recently committed to bringing forward legislative proposals to harmonize the accessibility requirements used by Member States. A new procurement directive package contains stronger obligations on public bodies to include accessibility as mandatory requirements in Technical Specifications. In parallel to this, a standardization mandate by the Commission to the European Standards Organizations (ESOs) concluded in March 2014 with the publication of the first European standard on ICT accessibility. In light of these developments, this article analyses the trajectory of European policy in the field of accessibility over the last two decades, and the interplay between European public procurement, standardization and law. It examines how far these developments have succeeded in bringing into being a public procurement eco-system that will nudge the market in Europe to producing affordable and accessible ICT products and services for persons with disabilities.     

A Struggle for Competence: National Security,Surveillance and the Scope of EU Law at the Court of Justice of European Union

In Privacy International and Quadrature Du Net, the Grand Chamber of the CJEU ruled that the e-Privacy Directive generally prevents bulk retention and transmission of traffic and location data, unless Member States can prove serious threats to national security. In such cases, bulk data can be retained during a strictly necessary period, subject to review by a court or independent administrative body. The judgments will impact other data retention and sharing arrangements, such as the PNR, proposed e-Privacy Regulation and e-Evidence package, and adequacy decisions under GDPR, including for post-Brexit UK. The rulings suggest the CJEU's significance in national security, which has been outside of European integration, but has become a ground for political struggle between EU institutions and Member States. While Privacy International unequivocally asserts CJEU's authority in national security and is a victory for data protection, Quadrature Du Net does not oppose indiscriminate data retention in principle and is an ambivalent response to political pressure.     

Last-ditch attempt to improve the EU patent system

The European Commission has proffered a compromise seeking torevitalize the ongoing debate on the patent system in Europeby enabling Member States to reach a consensus.     

Reconsidering the Premises of Labour Law: Prolegomena to an EU Regulation on the Protection of Employees' Personal Data

With its 1985 Directive on Data Protection, the European Union highlighted its commitment to the constitutionalisation of European law and, in particular, underlined its vision of the individual European as a rights-bearing individual; empowered through 'knowledge' and thus advantaged in communicative processes of political/social/legal bargaining. As such, the move to a data protection regime founded upon notions of individual empowerment, also mirrors a recent and fundamental re‐alignment in the guiding principles of regulative labour law, which has seen the paradigm of 'collective laissez‐faire' challenged, if not superseded, by a redirected emphasis upon the communicative empowerment of the individual employee rather than the representative function of employees' representatives. Accordingly, it is less than surprising that the field of labour law has seen increasing demands placed upon the Commission to fulfil its promise in the pre-amble to the 1985 Directive, and promulgate Regulations crafted to ensure data protection in line with the specific demands of individual societal sectors. This paper is a policy statement. It re-iterates the need for a Regulation on the protection of employees' data. Building on the comparative experience of the Member States, it outlines the nature, provisions and scope which such a regulation should entail so as to reflect, both the reality of the modern employment relationship, and a new normative vision of the workplace which aims to inject such relationships with a measure of communicative participation.     

An inquiry into the legal status of the ECOWAS cybercrime directive and the implications of its obligations for member states

On 19 August 2011, the ECOWAS Council of Ministers adopted Directive C/DIR.1/08/11 on Fighting Cybercrime at its Sixty Sixth Ordinary Session in Abuja, Nigeria. The adoption of the Directive at that time arose from the need to tackle the growing trend in cybercrime within the ECOWAS region, as some Member States were already gaining global notoriety as major sources of email scams and Internet fraud. Accordingly, the Directive established a legal framework for the control of cybercrime within the ECOWAS region, and also imposed obligations on Member States to establish the necessary legislative, regulatory and administrative measures to tackle cybercrime. In particular, the Directive required Member States to implement those obligations “not later than 1st January, 2014″. This article undertakes an inquiry into the legal status of the Directive as an ECOWAS regional instrument in the domestic legal systems of Member States.In this regard, the article examines whether the requirement regarding the superiority or direct applicability of ECOWAS Community laws such as ECOWAS Acts and Regulations in the domestic legal systems of Member States also apply to ECOWAS Directives such as the Cybercrime Directive. The article also examines the legal implications of the Directive's obligations for Member States. The article argues that while some Member States have not implemented the obligations under the Directive, that those obligations however provide a legal basis for holding Member States accountable, where the failure to implement has encouraged the perpetration of cybercrime that infringed fundamental rights guaranteed under human right instruments such as the African Charter on Human and Peoples’ Rights or under their national laws.     

Credible Commitment in Non-Independent Regulatory Agencies: A Comparative Analysis of the European Agencies for Pharmaceuticals and Foodstuffs

Abstract: The creation of more and more supranational regulatory agencies has been one of the most significant institutional developments in the European Union during the last decade. Usually, these agencies evolve from EU committees and take over most of their structures. Accordingly, like most EU committees and the Commission, regulatory agencies are not independent, but act under the control of the member states. The question is, how far do they indicate a credible commitment of the Member States to long-term policy goals like health and consumer protection. This article compares the institutional structures and decision-making rules of the European Agency for the Evaluation of Medicinal Products and of the newly established European Food Safety Authority, in order to clarify the extent of credible commitment that the Member States show through the setting-up of these agencies. It concludes that the commitment of the Member States in the foodstuff sector is not as deep as in the pharmaceutical sector, and that the creation of the European Food Safety Authority will not lead to a success story similar to that of the European Agency for the Evaluation of Medicinal Products.     

EU Refugee Qualification Directive: a Brave New World?

This article aims to map some of the major implications forasylum–related law in Europe of the Refugee QualificationDirective, which twenty-four EU Member States were requiredto implement by 10 October 2006. It seeks to build on importantstudies of the Directive completed by, among others, Hemme Battjes,in his book European Asylum Law and International Law, Nijhoff2006, and Jane McAdam, in her book Complementary Protectionin International Refugee Law, OUP 2007, albeit it takes a differentview of some key questions. Part 2 deals with the impact of the Directive on the applicationand interpretation of the 1951 Refugee Convention and its 1967Protocol. It is argued that, even read simply as a set of provisionsgiving interpretive guidelines on the application of the RefugeeConvention, it affects many things concerned with refugee eligibility,since these provisions cover key elements of the refugee definition. Part 3 deals with the impact of the Directive on the asylum-relatedhuman rights jurisdiction that currently prevails in Europein one form or another.¹ It is argued that the effect of theDirective is and must be to render Article 3 ECHR protection– or its domestic equivalent – a largely residualcategory, save in exclusion cases. Part 4 addresses to what extent, if at all, the Directive containsmandatory provisions and how, post-implementation, these canbe integrated into the national law of Member States. It isargued that, considered in purely textual terms, the key definitionaland interpretive provisions of the Directive are mostly in mandatoryform. Further, that whilst, by virtue of being a minimum standardsdirective, the Directive allows Member States to introduce orretain more favourable standards (A3), the same article stipulatesthat such standards must be compatible with the Directive. Thatproviso is of some importance given that the Directive’spreamble (at R7) identifies as one objective the avoidance ofsecondary movements. In relation to articles of the Directivewhich specify in mandatory terms how elements of the refugeedefinition are to be applied, Member States cannot be free tointroduce or retain differing standards. Parts 5 and 6 analyse suggested differences, first, betweenthe Directive’s refugee definition and the Refugee Convention(it is argued that the only potential difference of real significanceconcerns the Directive’s rendering of the Article 1F exclusionclauses of the Refugee Convention) and, secondly, between theDirective’s subsidiary protection definition and Article3 ECHR. The extent of symmetry between the new subsidiary protectioncriteria and ECHR protection under Article 3 is explored, inparticular, arguing that, whilst there are three respects inwhich subsidiary protection criteria are narrower (relatingto personal scope; the existence of cessation and exclusionclauses; and limited application to ‘health cases’),there may be limited respects in which it may be broader inscope than Article 3 ECHR. Part 7 examines patterns of implementation in the light of earlyevidence to hand from, for example, the November 2007 UNHCRsurvey of five Member States. The UK is considered as a furtherexample, that of a member state where, despite it being seenas unnecessary to make any substantial changes, the implementingmeasures have required important changes in method of approachand in conceptual language.     

Divisions of labour: maternity protection in Europe

Incapacity for work on the grounds of pregnancy and birth-related illness has long proved problematic for the courts, resulting, on occasion, in lawful dismissal based on a comparison between the woman concerned and a sick male worker. The European Court of Justice has recently clarified the duration of the 'protected period'that lasts throughout pregnancy and the period of maternity leave, during which dismissal will be prohibited. However, the duration of leave provided by Member States differs, resulting in a wide degree of variation for such protection. Furthermore, where illness arises or persists following childbirth, women will continue to be vulnerable to dismissal. This article considers the impact of caselaw developments and examines the provision of maternity leave in Europe, which, contrary to the harmonization originally envisaged by the introduction of the Pregnant Workers Directive (92/85/EEC), appears to be subject to a high degree of variation.     

Private Damages Actions Under EU Competition Policy: An Exploration of the Ongoing Sea Change in Respect of Such Actions Concerning Articles 101 and 102 TFEU Infringements

The EU has an established history of public enforcement concerning antitrust infringements under what are now Articles 101 and 102 of the Treaty of the Functioning of the European Union (TFEU). Yet, until recently, this has not been true in respect of private compensatory damages actions in relation to the said articles. Hence, these actions are now seen as reinforcing the existing deterrent provided by pubic enforcement fines. This paper focuses upon the ongoing sea change that aims to enable and encourage compensatory damages claims in relation to harm caused by breaches of 101 and 102 TFEU. It reveals that both the Court of Justice of the European Union (CJEU) and the European Commission have played pioneering roles in advancing this sea change. It further asserts that, although the rulings of the CJEU have created a hybrid architecture that makes possible private actions in relation to the said breaches under Member state procedural laws before national courts, the architecture itself is problematic as it fails to guarantee that Member states’ procedural rules have a high degree of uniformity, thereby failing to guarantee a regulatory level playing field across the Union concerning the said damages actions. Moreover, not only is the architecture problematic, but it needed further development in respect of rules and requirements in several key areas, such as the right of evidential disclosure, the limitation period issue, collective redress and the quantification of harm, so as to facilitate and encourage claims. The Commission was aware of these concerns, and this paper explores its response. The issues could have been addressed by the establishment of a set of EU procedural rules which national courts would apply in the said actions but the Commission decided upon a different way forward. Working with the said hybrid architecture, and through the vehicle of the 2014 Directive on certain rules governing actions for damages under national law for infringements of the competition law provisions of the Member States and of the European Union, the Commission has amended and created rules and requirements which will form part of Member states’ domestic procedural law—and therefore will be applied by national courts—in order to establish a more level regulatory playing field across the Union which should facilitate and encourage private compensatory damages actions for harm caused by EU antitrust breaches. Of course, a more level playing field means that differences will still remain. Moreover, it will be some time before the success of the Directive can be gauged, and further measures may be required in the future.     

Debate on patentability of biotechnological studies in Turkey.

The article examines the legislative attempts to regulate the protection of biotechnological inventions through patent in Turkey. In line with the membership process of Turkey to the European Union, the Turkish Draft Law on the Protection of the Patent Rights is in compatible course with the Directive 98/44 EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions. According to, the present article holds a critical view towards the Turkish Draft Law on the Protection of the Patent Rights and the EU Directive. Concepts of invention, discovery, simple and qualified invention that are in the both instruments are especially examine.     

The Norwegian Barents Sea Management Plan and the EC Marine Strategy Directive: Some Political and Legal Challenges with an Ecosystem-Based Approach to the Protection of the European Marine Environment

This article addresses some of the implications of the EU's proposed Marine Strategy Directive for ongoing work in the regional seas conventions and for national work on regional marine strategies. The starting point is the proposed directive's focus on the ecosystem approach to the protection of the marine environment. Key elements within this approach are analysed, such as integration of environmental considerations into other policy areas; introduction of ecological quality objectives; and establishment of holistic monitoring and assessment programmes. Is it possible to transform these concepts into legally binding obligations? What will the implications of the proposed directive be for the rights and obligations of EU Member States under international law? A Management Plan for the Norwegian Part of the Barents Sea ('Barents Plan') was adopted by the Norwegian Government in March 2006 and approved by the Norwegian Storting (Parliament) in June 2006. It provides an example of a concrete application of the concepts in the proposed directive. Based on an analysis of the proposed Marine Strategy Directive and the Barents Plan, some key political and legal challenges are discussed in this article.     

Bridging the Gap: Humanitarian Protection and the Convergence of Laws in Europe

This article uses the thematic of humanitarian protection to examine the convergence of laws in Europe. It considers the heterogeneous architecture of the Refugee Convention and European Convention on Human Rights then analyses the homogenous framework of the EU's Common Asylum System and, in particular, the Qualification Directive. It argues that in an area where international, regional and national laws intersect, convergence needs to be underpinned by Member States adopting a common interpretative methodology that has international law at its core. Article 15 of the Qualification Directive (QD) is used to illustrate how this can be achieved. The article adds to the growing literature on the convergence of laws in Europe and illustrates the importance of adopting a common interpretative methodology. It suggests a paradigm for protection regimes around the world and a methodology that could be transplanted to other areas of law involving the intersection of international, regional and national laws.     

Telecommunications terminal equipment: EEC commission opens the market

The 12 Member States of the European Economic Community (EEC) are legally obliged by the Treaty of Rome, as amended by the Single European Act, to abolish all of the remaining physical, technical and fiscal barriers between them by 31 December 1992. The Single European Act, which sets the 1992 deadline, defines the envisaged internal market as “an area without internal frontiers”.The creation of a common European market for telecommunications services and equipment is both an essential prerequisite and an important part of the “internal market”.In its Green Paper on the Development of the Common Market for Telecommunications Services and Equipment — “the Green Paper”¹⁾) — and a follow-up Communication²⁾, the Commission of the European Communities (“the Commission”) has set forth its main policy proposals in the telecommunications field. Implementation of these policy proposals by means of Community law directives is progressing rapidly, in particular with respect to terminal equipment. On 16 May 1988, the Commission issued a“Commission Directive on Competition in the Markets in Telecommunications Terminal Equipment” — “Terminal Equipment Directive” —³⁾ based on its regulatory powers under Art. 90(3) of the Treaty of Rome (“EEC Treaty”).This article explores the regulatory scope of the Terminal Equipment Directive which has recently been challenged by the French government before the European Court of Justice.     

Foreign Investors in the EU—Which ‘Best Treatment’? Interactions Between Bilateral Investment Treaties and EU Law

Abstract: This article discusses the main interactions between bilateral investment treaties (BITs) and EU law. The European Commission identified a number of incompatibilities in BITs signed by eight recent Member States with the USA, proposing solutions for their adjustment in conformity with EU law, but was this step sufficient? The risk of disputes remains, as long as the proposed adjustments do not achieve legal force and as long as other BITs still need to be harmonised with EU law. Moreover, provisions in BITs that are not in conflict with EU law could still be challenged if the application of certain EU requirements by Member States interferes with foreign investors' rights. To avoid such risks, coherence between different commitments and practices of the Member States is needed and coordination at the EU level is highly desirable.     

Protection Orders in the European Member States: Where Do We Stand and Where Do We Go from Here?

This article tries to provide an overview of current criminal, civil and administrative protection order legislation in the 27 European Member States by comparing five studies that have (laterally) touched upon this topic. Although the data are sometimes questionable and, on occasion, even contradictory, the general picture emerges that there is a huge variation in levels of victim protection across the EU. In some Member States there are considerable gaps in victim protection legislation, for example, because there is no (pre-trial or post-trial) protection in criminal proceedings or because civil protection orders and/or barring orders are not available. If we agree that in the light of today??s emphasis on victim protection the current gaps in protection order legislation can no longer be accepted, a strategy needs to be devised on how to solve this problem. It was argued that the European Union could play an important part in addressing the protective vacuum, first by supporting thorough research into the current status of protection order legislation and implementation in the 27 Member States, and second by further exploring certain ??soft law?? possibilities such as co-regulation or the open method of coordination.