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Ever since the publication of the General Programmes of 1962, regulating the internal market for services has been a riddle for the EU. In its effort to open up trade in services, the EU legislature has tried and erred — with occasional successes — in various ways. Traditionally, a basic distinction is drawn between, on the one hand, sector-specific and, on the other hand, horizontal legislation. Helpful as it may be, this distinction is neither accurate nor historically precise. This chapter describes the basic regulatory blocks adopted by the EU legislature, and then subjects them to more appropriate normative classifications.

States invoke their national identities not only against Treaty provisions, but also against EU legislation. The European Court of Justice then needs to assess whether identity respect warrants a distinct domestic interpretation of the EU Act, or even a national limitation of the requirements it imposes. This type of case is discussed in the final chapter. It deserves to be treated separately, as it raises questions not only about the optimal mix of accommodation and integration, but also about the proper relationship between the European Court of Justice and the EU legislature. By analogy with the scheme advanced in Chapters 6 to 9, the premise underlying this chapter is that there are good reasons for constraining the Court’s discretion in construing EU legislation and monitoring domestic interpretations of EU legislation. Drawing on insights from US legal scholarship, it is argued that canons of statutory interpretation, such as deference canons, could fulfil such a discretion-constraining role.

Studies the catastrophe insurance monopoly in Spain, the Consorcio the Compensacion de Seguros. It is shown that the Consorcio operates with exceptionally low administrative costs. It is able to offer a very low cost insurance cover in a domain, where competition would usually lead to market failure due to problems of adverse selection. The existence of the Consorcio is in contradiction with the 3rd EU guidelines on the insurance market. However, Spain managed to get an exemption.

This chapter outlines the laws that govern the manufacture and supply of medical devices in the EU and UK, both multi-faceted and internationally well-regarded legislative regimes. It contextualises these laws within the broader framework of the EU’s new approach to product safety legislation, in which these medical devices regimes were established. It discusses the core principles and fundamental statutory concepts under the EU and UK legislation that have been reinforced and improved upon over forty years of legislative history. Recent legislative change and the impact of Brexit is discussed in detail in that regard. The chapter also describes the regulatory environment in which Europe’s substantial medical devices industry operates, an industry which is estimated by the European Commission in 2019 as being comprised of 500,000 different types of medical devices and worth €100 billion. An outline of key regulatory bodies and functions is also provided.

One of the key features of the development of EU law is the amendment of its Treaties. These amendments often make significant changes to the primary law framework of the EU, for instance as regards the composition of EU institutions, the abolition of Member States’ vetoes, the conferral of more powers upon the EU and the protection of human rights. Owing to its fundamental importance to the development of EU law, the Treaty amendment process has always played a central role in European legal and political studies.

EU law is divided into primary and secondary legislation. EU primary legislation is made up of the provisions of the Treaties, general principles and international agreements to which the Union is a party. EU secondary legislation is made up of all acts adopted by the EU institutions in the exercise of their powers under the Treaties. Chapter 2 of Title I to Part 6 of the TFEU deals with the legal acts making up EU secondary legislation and the procedure for their adoption.

Any processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union should be carried out in accordance with this Regulation, regardless of whether the processing itself takes place within the Union. Establishment implies the effective and real exercise of activity through stable arrangements. The legal form of such arrangements, whether through a branch or a subsidiary with a legal personality, is not the determining factor in that respect.

Any judgment of a court or tribunal and any decision of an administrative authority of a third country requiring a controller or processor to transfer or disclose personal data may only be recognised or enforceable in any manner if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State, without prejudice to other grounds for transfer pursuant to this Chapter.

Many of the principles of administrative law discussed previously will be familiar to scholars from their domestic jurisprudence. The precautionary principle differs in this respect. While it is found in some legal systems, such as Germany, it is nonetheless relatively novel as a precept of administrative law. It has, however, become of increased importance in EU law.

This chapter highlights issues of data governance and public procurement. It first examines some of the unique data governance considerations applicable to public sector decisions about cloud adoption; while acknowledging that data governance is only one element in a decision to move to cloud. The chapter then identifies potential obstacles in the EU procurement framework that is not adapted to, or creates de facto barriers to, public sector cloud adoption and considers how these barriers could be addressed. The first potential legal barrier to public sector take-up of cloud concerns public sector data governance and the legal requirements concerning the security of, and access to, public sector data. The second potential legal barrier concerns EU public procurement legislation and the extent to which it is not adapted to the cloud environment.

This chapter explains decision-making in the European Union for the purpose of implementing legislation. It looks at implementation by the Member States and implementation by Union institutions, bodies, offices, or agencies. The Treaties did not set up a uniform system for the implementation of Union legislation: where necessary, each act determines its implementation procedures itself; where the act in question does not do so, the principle applies that 'Member States shall take any appropriate measure, general or particular, to ensure fulfilment of the obligations arising out of the Treaties or resulting from the acts of the institutions of the Union'. Since the Lisbon Treaty, the Treaties state that Member States are to adopt 'all measures of national law necessary to implement legally binding Union acts'. Accordingly, Union law is implemented as a rule by administration communautaire indirecte. Whether a legislative act provides for implementation at Union level or leaves implementation entirely to the Member States, the enforcement of the rules of Union law and the imposition of sanctions for breaches thereof fall primarily to the national administrative and judicial authorities. The Commission is empowered to conduct administrative inquiries itself and to fine individuals only very exceptionally.

This chapter discusses the negotiation and adoption of the new EU legislation over the years 2006–2008. This is when the paradigm shift that had previously been framed in the scientific and economic fields was institutionalized in the bureaucratic field. The chapter first shows how a new set of officials in the Wine Unit of the Directorate-General for Agriculture and Rural Development (DG-AGRI) became the scribes of the reform who turned a range of policy proposals into a single package, moving their unit to the center of the bureaucratic field. This work and this repositioning cannot be separated from how the hierarchy of the directorate-general, most notably its commissioner, played a central role in the bureaucratic field. Resources drawn from the hierarchical position of the commissioner and her cabinet were clearly mobilized to politicize certain debates, technicize others, control the timeline of the reform and, more generally, legitimize it inside and outside the European Commission.

The Commission shall, if appropriate, submit legislative proposals with a view to amending other Union legal acts on the protection of personal data, in order to ensure uniform and consistent protection of natural persons with regard to processing. This shall in particular concern the rules relating to the protection of natural persons with regard to processing by Union institutions, bodies, offices and agencies and on the free movement of such data.

Recital 6; recital 48; recital 102; Article 45 (Adequacy decision) (see too recitals 103–107); Article 46 (Transfers subject to appropriate safeguards) (see too recitals 108–109); Articles 4(20) and 47 (BCRs) (see too recital 110); Article 48 (Transfers not authorised by EU law) (see too recital 115); Article 49 (Derogations) (see too recitals 111–114); Article 50 (see too recital 116); Article 83(5)(c) (Fines for non-compliance with data transfer restrictions); Article 96 (Relationship with previously concluded agreements of the EU Member States).

Article 5 (Principles relating to processing of personal data) (see too recitals 41, 45 and 50); Article 12 (Transparent information, communication and modalities for the exercise of the rights of the data subject); Article 13 (Information to be provided where personal data are collected from the data subject); Article 14 (Information to be provided where personal data have not been obtained from the data subject); Article 15 (Right of access by the data subject); Article 16 (Right to rectification); Article 17 (Right to erasure, ‘right to be forgotten’); Article 18 (Right to restriction of processing); Article 20 (Right to data portability); Article 21 (Right to object); Article 22 (Automated individual decision-making, including profiling); Article 34 (Communication of a personal data breach to the data subject).

Article 30 (Records of processing activities) (see too recital 82); Article 33 (Notification of a personal data breach to the supervisory authority) (see too recital 85); Article 35 (Data protection impact assessment) (see too recitals 90–91); Article 36 (Prior consultation) (see too recital 94); Article 38 (Position of the data protection officer) (see too recital 97); Article 39 (Tasks of the data protection officer) (see too recitals 77 and 97).

Article 77 (Right to lodge a complaint with a supervisory authority) (see too recital 141); Article 78 (Right to an effective judicial remedy against a supervisory authority) (see too recital 141); Article 79 (Right to an effective judicial remedy against a controller or processor) (see too recitals 141 and 145), Article 80 (Representation of data subjects) (see too recital 142); Article 81 (Suspension of proceedings) (see too recital 144).

This chapter explores fit and proper assessments as an instrument of accountability. MiFID II and other pieces of EU legislation require members of administrative, management, or supervisory bodies of regulated undertakings in the financial sector to be suitable for their positions, or ‘fit and proper’. The objective of the fit and proper assessment is to ensure that investment firms are managed by competent persons, in order to protect investors and market stability. Fit and proper assessments of members of management bodies of investment firms may serve as instruments of accountability, alongside administrative sanctions and criminal or civil liability, since regulatory breaches or other instances of misconduct of the firm or the person will have a negative impact on the assessment of fitness and propriety. The risk of being assessed negatively, and being removed from management bodies, or being denied a new position may, therefore, have a deterrent effect on managers, and foster sound (risk) management.