In a significant, yet unusual judgment the Court of Justice of the European Union (CJEU) upheld the General Court’s decision (T-140/12; Teva Pharma v. EMA) that had affirmed the European Medicines Agency’s (EMA) rejection of Teva’s generic drug application for Glivec® (active substance-imatinib), not due to the reference product’s own orphan drug exclusivity but in view of orphan drug exclusivity of a similar medicinal product – Tasigna® (active substance-nilotinib).
The judgment is bizarre not only because it interprets the underlying orphan drug regulation in a manner incongruous with the spirit and substance of the legislation, but also for its potential to provide an unfair leg-up to the brand drug companies for extending their market monopolies indefinitely. It simply fails to fathom the underlying welfare rationale of the Regulation, which is meant to ensure the same quality of treatment for patients of rare conditions as those suffering from other diseases. The Court’s decision provides a skewed playing field where the interest of patients and generic pharmaceutical companies will be impacted by the unjustified extension of monopoly periods of brand drug products thus ensuring exploitative pricing of life-saving drugs. Continue reading →
The civil liability of intermediary service providers remains a hotly debated topic in EU law, especially in relation to infringement of intellectual property rights (IPRs). Whereas the Information Society Directive (Directive 2001/29/EC), as well the IP Enforcement Directive (2004/48/EC) provide that owners of IPRs can, in principle, request injunctions against intermediaries, the E-Commerce Directive (Directive 2000/31/EC) exempts certain intermediaries from indirect liability under certain, well defined circumstances. The present case raises questions as to the scope and interpretation of Article 12 of the E-Commerce Directive, in particular with regard to fundamental rights. Concretely, the referring court in Tobias Mc Fadden v Sony Music Entertainment Germany GmbH asks under which circumstances and to what extent operators of publicly accessible Wi-Fi networks can be held liable for infringements of works protected by copyright, and what type of injunctions can be ordered against such operators.
The James Elliott Construction case brings before the Court of Justice (ECJ), for the first time, the issue of whether it is within the Court’s jurisdiction to give preliminary rulings on harmonised technical standards (HSs). This contribution will analyse Advocate General (AG) Campos Sánchez-Bordona’s Opinion in this case, in particular its potential effects on the legal status and copyright protection of HSs. It will also discuss, more generally, the legality of the delegation of rule-making powers to the European Standard Bodies (ESBs). If the Court follows the AG’s opinion it will most certainly craft a New Approach to the New Approach.Continue reading →
Data protection policy, in particular the right to protection of personal data in Article 8 of the EU Charter, has remained firmly within the EU law limelight in recent years. This right played a key role in seminal judgments of the CJEU such as Schecke and Eifert, where for the first time a provision of secondary legislation was annulled for incompatibility with the Charter, and in Digital Rights Ireland (discussed earlier on this blog), where for the first time an entire Directive was annulled on the same grounds. Furthermore, in Google Spain (considered here) this fledgling right was ostensibly given precedence over the more established right to freedom of expression in certain circumstances, leading to a media furore on both sides of the Atlantic. 2015 was no different in this regard as much attention focused on the Court’s judgment in Schrems (discussed here), which invalidated the 15 year old Safe Harbor data sharing agreement between the EU and the US, and on the culmination of four years of negotiation on the new Proposed General Data Protection Regulation in December.
For good or for bad, the EU data protection juggernaut appears unstoppable, leaving in its wake legal instruments that do not meet its strict standards. Yet, in the shadows of these well-documented events, other noteworthy developments occurred. 2015 also saw the Dutch referring court withdraw its preliminary reference in Rease and Wullems, thereby regrettably removing the opportunity for the CJEU to pronounce upon the margin of discretion of national Data Protection Authorities (DPAs) when adopting a de minimis approach to their enforcement strategy to the detriment of individual or small group complainants. The Court did, however, deliver a number of largely overlooked yet significant data protection judgments in 2015. This contribution will focus on two significant cases which the CJEU delivered in the first week of October, immediately prior to the Schrems judgment, in Bara and Weltimmo. These preliminary references allowed the Court to clarify the interpretation of obligations and exemptions under the Data Protection Directive, as well as the Directive’s enforcement in online situations. Continue reading →
“Viking, Laval and Beyond”, edited by Mark Freedland and Jeremias Prassl, constitutes the first volume of Hart’s new series on “EU Law in the Member States”. In the series’ foreword Sacha Prechal lays out how crucial it is to understand the “genuine life of EU law in the Member States” since EU law – of course – is generally transposed, applied and enforced at the domestic level. But that is easier said than done. One needs good knowledge of EU law, domestic and comparative (EU) law to come close to some understanding of what Prechal calls EU law’s genuine life. And, let’s be honest, it is often hard enough to keep up with the current developments in EU law while not losing touch with domestic legal issues. Continue reading →
Last week, the ECJ delivered its judgment in Case C-398/13 P, Inuit Tapiriit Kanatami II, which deals with the EU ban on trade in seals products. This judgment is interesting for two reasons. Firstly, the absence of any consideration of the admissibility question, more specifically the fulfilment of the locus standi requirements. Secondly, the relationship between, on the one hand, the Charter of Fundamental Rights and the ECJ and, on the other hand, the European Convention on Human Rights (ECHR) and its court, the European Court on Human Rights (ECtHR). This post will examine these two issues after a discussion of the background to the so-called “Inuit Saga” and the eventual ECJ judgment which came about after more than five years of litigation in two different episodes.
Situated between the market and the state, the notion, concept and characteristics of public services are often multifaceted and difficult to grasp. The EU layer of public service regulation further adds to this complexity as it interacts in many different ways with the national legal frameworks in this field: EU law may structure national legal norms, coordinate the provision of services between the Member States, bring about minimal or maximal standards (e.g. pertaining to quality, ubiquity or affordability of the services provided), comprise detailed regulation or even set prices for the provision of public services as in the case of mobile roaming tariffs. At the same time the law on public services is under the influence of a whole range of EU law provisions and regimes: namely the rules on free movement, competition law and state aid, general and sector-specific primary law provisions, horizontal rules of secondary law, as well as a large body of sector-specific secondary EU law, which has increased substantially over the past few years. With his book Public Services in EU Law Wolf Sauter undertakes a challenging attempt to elucidate the complexity of EU law in the field of public services. Continue reading →
When rendering one of its last judgments of 2014, the Court of Justice of the European Union (Court) had the opportunity to end once and for all the dispute of (now) three rounds between the United Kingdom (UK) and the Council of the European Union (Council) over the legal basis to be used when the EU wishes to adopt jointly, within the framework of an association agreement with a third country, a social legislation benefitting the migrating workers of both parties.
As the UK did in earlier cases on this topic submitted to the Court, in case C-81/13 UK v Council it criticised the Council once more for using Article 48 TFEU as the substantive legal basis for the adoption of a social security measure implementing an association agreement, in this particular case the Council Decision 2012/776/EU, which aimed to update the obsolete implementing provisions on the coordination of social security systems as established by the EEC-Turkey Association Agreement (Agreement).
The following post discusses whether the judgment delivered by the Grand Chamber of the Court in this case has been successful in finally bringing the above-mentioned dispute to an end, and it also provides a closer look on the Court’s reasoning as regards the choice of legal basis in relation to the measures implementing association agreements. Continue reading →
Sometimes a book wins you over, and José Luís Da Cruz Vilaça’s EU Law and Integration: Twenty Years of Judicial Application of EU Law (Oxford/Portland, Hart 2014), is such a book.
I must admit that I had some reservations at first over the concept of the book, which is in essence an overview of the legal career – both as a legal scholar and a judge – of José Luís Da Cruz Vilaça, on the basis of a series of articles on different topics written over the course of two decades. Books like this only stand out if they can avoid three traps. Continue reading →
Parody is one of the limitations on copyright, contained in Article 5(3)(k) of the InfoSoc Directive (‘the Directive’). The list of limitations in Article 5 of the Directive is optional, meaning that the Member States are free to decide which of the limitations from the list they will implement into their national laws. The judgment in Deckmyn v. Vandersteen, issued on September 3rd, is about the concept of parody in the EU copyright law and it is meant to clarify two issues: the scope of harmonization of the parody limitation in the Directive and the criteria to be looked at when applying this limitation. The potential impact of the judgment, however, goes well beyond the pure sphere of copyright: at stake here was also the issue of balancing of the fundamental rights, in particular the balance between copyright and freedom of speech. The Advocate General went further than the Court and also looked at the conflict between the right of ‘human dignity’ (para. 82 of the Opinion) or ‘deepest convictions of European society’ (para. 85 of the Opinion) and the freedom of speech. Unfortunately, the brevity with which the CJEU addressed the most controversial aspects of this case, leaves many questions unanswered. Continue reading →
The Court has recently decided on the appeals in two seminal cases: MasterCard MIF (MasterCard) and Groupement des Cartes Bancaires (CB). Both cases result from Commission decisions that found Article 101 TFEU to have been infringed by the decisions taken within those schemes with regard to fees that form part of the working of these payment systems. To understand both cases it is necessary to first set out the background to the MasterCard and CB systems. After that we will examine the procedure and finally the judgments themselves. This will reveal essentially three interesting issues:
In October 2012 I wrote an entry about the General Court judgment that annulled the Commission decision in the Greek Lignite-saga, concerning the Greek state-owned electricity company DEI that benefitted from the exclusive right to mine for lignite (brown coal) which, according to the Commission, distorted competition. In a nutshell I found that the judgment did little to clarify the obscure clarity or clear obscurity of Article 106 TFEU, but it was certainly good news for DEI, the state-owned electricity company that benefitted from the exclusive right to mine for lignite. In that blog I wrote that the Commission should appeal so that the Court could clarify its own case law (instead of the General Court second-guessing what the Court could have meant). Well, the Commission did appeal, but I’m not sure whether the Court clarified its own case law. One thing that is for sure it that Article 106 TFEU may well have been given a new lease of life. This turns on the question whether actual abuse by the public undertaking must be shown in Article 106 TFEU-cases. This follows from the fact that Article 106 TFEU is addressed to the Member States, but is an empty norm that only gets substance when it is read in conjunction with another Treaty provision. In this regard Article 102 TFEU is by far the most popular norm to be mated to Article 106 TFEU as the exclusive right mentioned in Article 106 TFEU is easily equated to a statutory monopoly for the public undertaking and thus dominance within the meaning of that provision.
The free movement of capital provision of Art. 63 TFEU applies ratione loci ‘worldwide’: to both capital movements within EU’s internal market and to movements from the internal market to third countries (and vice versa). Or perhaps almost worldwide, since the question arises whether the free movement of capital also applies to the British, Danish, Dutch and French Overseas Countries and Territories (OCTs), which are not part of the internal market but associated with the EU?
In 2011, the CJEU decided in Case C-384/09 Prunus that Art. 63 TFEU also applied to the OCTs as if they were third countries; they are not third countries, since they áre part of the EU Member States (such as the Caribbean island of Curacao which is part of the Kingdom of the Netherlands, both constitutionally as under public international law; under EU-law, Curacao is an OCT).
Now, only three years later, the CJEU has decided otherwise in joined cases C-24/12 and C-27/12 X BV and TBG Limited. It came to the conclusion that not Art. 63 TFEU applies to the OCTs, but that a special capital movement provision which is contained in the OCT Association Decision applies in relation to the OCTs. This latter provision liberalises – in my view – ‘less’ than Art. 63 TFEU, since it ‘only’ applies to ‘direct investments in companies’, whereas Art. 63 TFEU also applies to (at least) 12 other categories of capital movements, such as investments in immovable property.
In this very interesting Grand Chamber judgment, the Court found Sweden’s scheme promoting the national production of green electricity (in accordance with Directive 2009/28, the so-called RES Directive) to be compatible with article 34 TFEU. The Court’s judgment is particularly notable for its deferential stance towards measures related to environmental protection based on EU rules which – paradoxically – are very nationally oriented although they tackle the global problem of climate change. The judgment is to be welcomed for giving both the EU and its Member States sufficient policy discretion on how to mitigate the effects of climate change. On the other hand, the EU legislator’s national approach may not contribute to the achievement of a European electricity market. In adopting this deferential approach, the Court had to deal with some interesting legal issues relating to the free movement of goods, in particular:
The discriminatory nature of the rules in question and, despite this, their possible justification;
The impact EU legislation has on the proportionality analysis of the Court.
Where to draw the line between delegated acts and implementing acts? That has been the one million dollar question since the entry into force of the Lisbon Treaty. But I did not dare to ask this important question at the final exams of my students a few weeks ago. Why not? Because nobody, not even their teacher (after having spent years of research on the subject), had a plausible answer. However, on 18 March 2014, the Court of Justice in Commission v Parliament and Council, made a first attempt to answer this question. So would I now consider including this question in my next exam? Probably not, because the Court’s answer in this eagerly awaited judgment turns out to be quite hermetic and largely incomplete. Moreover, unfortunately, also the Opinion of the Advocate General – despite its deep analysis and ambitious tenor – failed to provide the necessary clarification to this endless and unsolved conundrum. Having said that, let me provide a brief analysis of this judgment and measure its most immediate impact.
It is common knowledge that, barring exceptional circumstances, only EU citizens who exercise their free movement rights can invoke the right to be joined or accompanied by close family members. An EU citizen who moves to another Member State can take his close family members along, even if the latter are not EU citizens themselves; the same is true when the EU citizen later returns to his home Member State. So far, everything is pretty much clear.
However, there still remains a large degree of uncertainty as to how much ‘movement’ is in fact required in order to be able to invoke this right. Does it suffice to go on a daytrip to another Member State (e.g. to visit an amusement park)? Does it suffice to work in another Member State without moving there? Is it necessary to reside in the other Member State for a number of months or even years?
‘to take the opportunity afforded by these two references to give clear and structured guidance as to the circumstances in which the third country national family member of an EU citizen who is residing in his home Member State but who is exercising his rights of free movement can claim a derived right of residence in the home Member State under EU law.’
In what follows, I will briefly discuss the CJEU’s judgments and analyse their key points. As will become clear, the Court did in fact respond to the AG’s call, by providing further clarification on this point. Continue reading →