What Is Possible and What Is Not? The Development of a Legal Framework for Drug Pricing Mechanisms in the EU

2019 ◽  
Vol 26 (2) ◽  
pp. 120-140
Author(s):  
Gisela Ernst
Keyword(s):  
Case Law ◽  
Legal Framework ◽  
Healthcare Systems ◽  
European Court Of Justice ◽  
The European Union ◽  
Pharmaceutical Pricing ◽  
Court Of Justice ◽  
European Court ◽  
Free Movement Of Goods ◽  
The Eu

Abstract As a result of the constantly increasing number of innovative but exceedingly high priced medicines, many Member States have implemented price-regulating mechanisms to ensure the financial viability of their healthcare systems. However, the European Court of Justice applies strict criteria to these measures – some of them have already been suspended for the purposes of the free movement of goods. The European Union (EU) allowed the development of an ever-stricter case law on one hand, without changing the legal frame on the other hand. Considering the importance and the binding nature of the Court’s judgements, this leaves great uncertainty for national legislators about which measures to remedy the pricing problem are legally possible and which are not. In order to provide clarity, this article seeks to analyse the development of the case law and to define the legal scope for pharmaceutical pricing mechanisms in the EU.

scholarly journals The European Court of Justice and the Policy Process

2018 ◽  
Author(s):  
Susanne K. Schmidt
Keyword(s):  
European Union ◽  
Member State ◽  
Case Law ◽  
European Court Of Justice ◽  
The European Union ◽  
Member States ◽  
Administrative Practices ◽  
Court Of Justice ◽  
European Court ◽  
The Eu

The European Court of Justice is one of the most important actors in the process of European integration. Political science still struggles to understand its significance, with recent scholarship emphasizing how closely rulings reflect member states’ preferences. In this book, I argue that the implications of the supremacy and direct effect of the EU law have still been overlooked. As it constitutionalizes an intergovernmental treaty, the European Union has a detailed set of policies inscribed into its constitution that are extensively shaped by the Court’s case law. If rulings have constitutional status, their impact is considerable, even if the Court only occasionally diverts from member states’ preferences. By focusing on the four freedoms of goods, services, persons, and capital, as well as citizenship rights, the book analyses how the Court’s development of case law has ascribed a broad meaning to these freedoms. The constitutional status of this case law constrains policymaking at the European and member-state levels. Different case studies show how major pieces of EU legislation cannot move beyond case law but have to codify its principles. Judicialization is important in the EU. It also directly constrains member-state policies. Court rulings oriented towards individual disputes are difficult to translate into general policies, and into administrative practices. Policy options are thereby withdrawn from majoritarian decision-making. As the Court cannot be overruled, short of a Treaty change, its case law casts a long shadow over policymaking in the European Union and its member states, undermining the legitimacy of this political order.

Treaty-making Procedures

2021 ◽  
pp. 57-100
Author(s):  
Jan Wouters ◽  
Frank Hoffmeister ◽  
Geert De Baere ◽  
Thomas Ramopoulos
Keyword(s):  
European Union ◽  
Case Law ◽  
European Court Of Justice ◽  
Historical Evolution ◽  
The European Union ◽  
Provisional Application ◽  
Court Of Justice ◽  
European Court ◽  
Important System ◽  
The Eu

This chapter provides an overview of the treaty-making procedures in the European Union. It explains the historical evolution of primary law in the field and gives examples for each step under Article 218 TFEU (negotiation, signature, provisional application, and conclusion). Excerpts of European Court of Justice (ECJ) case law illustrate how these provisions are interpreted and applied in practice. The chapter also discusses the principles covering suspension and termination of EU agreements, and the ever more important system that allows the EU to contribute to the adoption of international secondary law under Article 218, paragraph 9 Treaty on the Functioning of the European Union (TFEU). A final section describes EU practice for adopting non-legally binding instruments and reproduces the new guidance of December 2017 issued by the Council and the Commission in this respect after the ECJ’s judgment in the case relating to the EU–Swiss Memorandum of Understanding.

11. Free movement of goods II: non-tariff barriers

2020 ◽  
pp. 287-318
Author(s):  
Nigel Foster
Keyword(s):  
European Union ◽  
European Commission ◽  
Case Law ◽  
European Court Of Justice ◽  
Free Movement ◽  
Eu Law ◽  
The European Union ◽  
Court Of Justice ◽  
European Court ◽  
Free Movement Of Goods

This chapter examines European Union (EU) law concerning non-tariff barriers to free movement of goods. It describes member states’ attempts to influence imports and the way the European Commission and the European Court of Justice (CoJ) handled these issues. This chapter explains the provisions of the relevant legislation for non-tariff barriers, which include Articles 34, 36, and 35 of the Treaty on the Functioning of the European Union (TFEU). It also analyses example cases including ‘Dassonville’, ‘Cassis de Dijon’, and post ‘Keck’ case law. It concludes with a consideration of the latest trend of cases concerning product use and residual rules.

scholarly journals Ne bis in idem: a separation of acts in transnational cases?

2015 ◽  
Vol 7 (2) ◽  
pp. 85-115
Author(s):  
Márk Némedi
Keyword(s):  
Case Law ◽  
Fundamental Rights ◽  
European Court Of Justice ◽  
The European Union ◽  
Court Of Justice ◽  
European Court ◽  
Ne Bis In Idem ◽  
Charter Of Fundamental Rights ◽  
Criminal Matters ◽  
The Eu

Abstract This paper analyses the case-law of the European Court of Justice on the substantive scope of ne bis in idem in transnational cases and evaluates the findings in light of the different concepts of legal interests inherent in the concept of crime as a material notion. I argue that the application of the interpretation of the ECJ to crimes against collective interests is insufficiently justified. As a result, the interpretation of ne bis in idem based on material facts appears only partially correct and a sense of distrust seems to be cemented between member states creating obstacles to a successful reform of the principle. Part one attempts to defend that the reasoning put forward by the court lacks relevance and evaluates how this affects mutual trust. Part two analyses this interpretation in the light of different forms of legal interest. Part three examines how later case-law has tried to explain the problematic interpretation of early cases and its relationship with the Charter of Fundamental Rights of the European Union. The article will conclude by summarising the findings which may put into perspective the more general challenges of cooperation in criminal matters within the EU.

Part III Observance and Application of Treaties, 16 The European Courts and the Law of Treaties: The Continuing Story

2011 ◽  
Author(s):  
Kuijper Pieter Jan
Keyword(s):  
International Law ◽  
Case Law ◽  
European Court Of Justice ◽  
Vienna Convention ◽  
The European Union ◽  
Court Of Justice ◽  
European Court ◽  
Treaty Interpretation ◽  
The Law ◽  
The Eu

This chapter presents a critical analysis of the case law of the European Court of Justice and of the General Court relating to the application of the international law of treaties. It covers the some forty cases in which the Courts have referred explicitly to the Vienna Convention on the Law of Treaties 1969, and a few more where this happened implicitly, during the period 1998–2010. Inevitably the emphasis falls on the application of the rules of treaty interpretation to the international agreements concluded by the European Union (EU), but also to the founding treaties of the EU itself. The Courts have been confronted with great regularity with questions relating to the law of treaties and thus have become increasingly sophisticated in their use of it. The recent accusation that the Court is adverse to international law seems to be based on a few dramatic cases, not on the steady stream of smaller cases in which the law of treaties plays a role.

scholarly journals Free movement of workers in the EU and occupational pensions

2017 ◽  
Vol 19 (2) ◽  
pp. 141-157 ◽  
Author(s):  
Marion Del Sol ◽  
Marco Rocca
Keyword(s):  
Case Law ◽  
Legal Framework ◽  
Free Movement ◽  
The European Union ◽  
Occupational Pensions ◽  
Minimum Standards ◽  
Court Of Justice ◽  
Free Movement Of Workers ◽  
The Eu ◽  
Cross National

The European Union appears to be promoting at the same time both cross-national mobility of workers and an increased role for occupational pensions. There is, however, a potential tension between these two objectives because workers risk losing (some of) their pension rights under an occupational scheme as a consequence of their mobility. After long negotiations, the EU has addressed this issue through a minimum standards Directive. Shortly before the adoption of this Directive, the Court of Justice also delivered an important decision in the same field, in the case of Casteels v British Airways. By analysing the resulting legal framework for safeguarding pension rights under occupational schemes in the context of workers’ mobility, we argue that the application of the case law developed by the Court of Justice in the field of free movement of workers has the potential to offer superior protection compared to the Directive. We also highlight the fact that the present legal framework seems to afford a much fuller protection to the intra-company cross-national mobility of workers employed by multinational companies, while also seemingly favouring mobility for highly specialised workers.

The Practices of ‘Splitting’ and ‘Common Accord’ Under Scrutiny: the European Parliament‘s Request for an Opinion of the European Court of Justice on the Istanbul Convention

2020 ◽  
Vol 45 (4) ◽  
pp. 472-486
Author(s):  
Elizaveta Samoilova
Keyword(s):  
European Union ◽  
Legal Framework ◽  
Special Focus ◽  
The European Union ◽  
Member States ◽  
Court Of Justice ◽  
European Court ◽  
Forms Of Violence ◽  
Istanbul Convention ◽  
The Eu

Abstract With all eyes on the recent global COVID-19 pandemic, another pandemic has been growing in the shadows: violence against women. The Council of Europe’s Istanbul Convention creates a legal framework in order to protect women against all forms of violence. Its ratification process, however, has faced considerable challenges, particularly in the Central and Eastern European Member States. This article discusses the basic elements of the Istanbul Convention, reflects on the ratification process in the EU and its Member States, and sets out the main legal issues raised in the European Parliament’s request for an opinion (A-1/19 of 22 November 2019) to the Court of Justice of the European Union. Special focus is put on the choice of the correct EU legal basis and the practices of ‘splitting’ and ‘common accord’. This article argues that the European Parliament’s request for an opinion provides the perfect opportunity for the Court of Justice of the European Union to further clarify the law and the practice of concluding mixed agreements by the EU and its Member States.

Ne Bis Interpretatio In Idem?The Two Faces of theNe Bis In IdemPrinciple in the Case Law of the European Court of Justice

2017 ◽  
Vol 18 (1) ◽  
pp. 39-58 ◽  
Author(s):  
Alessandro Rosanò
Keyword(s):  
European Union ◽  
Human Rights ◽  
Case Law ◽  
European Court Of Justice ◽  
Antitrust Law ◽  
The European Union ◽  
Court Of Justice ◽  
European Court ◽  
Ne Bis In Idem ◽  
Regional Custom

The meaning ofidemin thene bis in idemprinciple is controversial in the case law of the Court of Justice of the European Union. In interpreting the provision of Article 54 of the Convention Implementing the Schengen Agreement, the court has emphasized the necessary requirement in the identity of the material acts while in antitrust law three requirements have been deemed necessary: (1) Identity of the facts, (2) unity of offender, and (3) unity of the legal interest protected. Despite the opinions of some Advocates General, the court has confirmed different interpretations of the same principle, depending on differences of the legal scope in question. A few years ago, however, the European Court of Human Rights proclaimed the criterion based on the identity of the material acts as the most suitable. This might push the Court of Justice of the European Union to correct its position in the antitrust field. Should this happen, this adjustment might serve as grounds to recognize the existence of a regional custom concerning thene bis in idemprinciple.

National Procedural Autonomy and General EU Law Limits

2019 ◽  
Vol 12 (2) ◽  
pp. 5-34
Author(s):  
Rob Widdershoven
Keyword(s):  
Case Law ◽  
European Court Of Justice ◽  
Eu Law ◽  
Procedural Law ◽  
Court Of Justice ◽  
European Court ◽  
Recent Approach ◽  
Procedural Autonomy ◽  
Judicial Protection ◽  
The Eu

This article examines the recent approach of the European Court of Justice of the EU towards the applicability of procedural national law in cases falling within the scope of Union law. It argues that the Court increasingly assesses such rules within the framework of the principle of effective judicial protection, as bindingly codified in Article 47 of the Charter of Fundamental Right of the EU since December 2009. This test is gradually replacing the rather deferential test on the Rewe principles of equivalence and effectiveness and implies a further limitation of procedural autonomy of the Member States. The reason for the shift seems to be the necessity to coordinate the Court's case law on Article 47 CFR with the case law of the European Court of Human Rights on Article 6 ECHR, because this coordination requires the application of a similar standard by both European Courts. As a result, the importance of, in particular, the Rewe principle of effectiveness, has already decreased to a considerable extent and might decrease further in future. Nevertheless, it is not to be expected that this standard will be abolished completely. First, because it may provide an adequate standard for assessing procedural issues that are not related to effective judicial protection or Article 47 CFR. Secondly, because incidentally it may be used by the Court for modifying national procedural law with a view to the effective application of substantive EU rules.

scholarly journals The Political Role of the European Court of Justice: How the EU Institutional Thresholds Shield the Integrationist Power of the Court

2019 ◽  
pp. 195-212
Author(s):  
Roberto Reyes Izquierdo
Keyword(s):  
European Union ◽  
European Court Of Justice ◽  
Legislative Process ◽  
The European Union ◽  
Political Role ◽  
Fundamental Factor ◽  
Court Of Justice ◽  
European Court ◽  
The Eu

The aim of this paper is to analyse how the European Court of Justice (ECJ) has been a fundamental factor in the integration process of the European Union, in spite of the obstacles posed by the intergovernmental dynamics that have traditionally hindered the construction of a stronger, cohesive and more integrated Europe. Important principles such as direct effect or supremacy of EU law have been developed through ECJ rulings and case law, even when such principles were not literally foreseen in the foundational Treaties. Therefore, this paper argues that the role and power of the Court as an “indirect law-maker” have been essential for the construction of the European Union, and this has been possible due to the complexities and weaknesses of the legislative process involving the three main decision-makers: the Commission, the Council of the EU, and the European Parliament.

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