Tamara K. Hervey

Health law and policy in the European Union

From its origins as six western European countries coming together to reduce trade barriers, the European Union (EU) has expanded, both geographically and in the scope of its actions, to become an important supranational body whose policies affect almost all aspects of the lives of its citizens. This influence extends to health and health services. The EUs formal responsibilities in health and health services are limited in scope, but, it has substantial indirect influence on them. In this paper, we describe the institutions of the EU, its legislative process, and the nature of European law as it affects free movement of the goods, people, and services that affect health or are necessary to deliver health care. We show how the influence of the EU goes far beyond the activities that are most visible to health professionals, such as research funding and public health programmes, and involves an extensive body of legislation that affects almost every aspect of health and health care.

The EU Charter of Fundamental Rights

The Charter of Fundamental Rights of the European Union enshrines the key political, social and economic rights of EU citizens and residents in EU law. In its present form it was approved in 2000 by the European Parliament, the Council of Ministers and the European Commission. However its legal status remained uncertain until the entry into force of the Treaty of Lisbon in December 2009. The Charter obliges the EU to act and legislate consistently with the Charter, and enables the EUs courts to strike down EU legislation which contravenes it. The Charter applies to EU Member States when they are implementing EU law but does not extend the competences of the EU beyond the competences given to it in the treaties.

Public health policies

Introduction This chapter considers how the European Union (EU) has discharged its obligations to develop and implement public health policy, obligations that arise primarily from its competences granted by Article 152 EC and Article 95 EC on the creation of the EUs internal market. In doing so, the EU confronts four important tensions. The first concerns the relationship between those matters that are national and those that are international. Throughout history, threats to public health have transcended national borders, initially in the form of infectious diseases and more recently in the form of trade in dangerous goods, such as tobacco. Yet, reflecting the absence of an appropriate international architecture, responses have largely been developed and implemented at a national level. This only began to change in the latter part of the nineteenth century, when a series of international sanitary conferences began a process that would, in time, lead to the creation of the World Health Organization. However, even now, international public health remains a state-based model, involving interactions among state-defined actors, albeit through institutions established in international law. The nub of this tension is that the EU is neither an international public health organization nor a state. The EU lacks the public health expertise, resources and experience of international bodies such as the World Health Organization, the World Bank or UNICEF. It also lacks the capacity – in particular, the financial and human resources – of a state, which would enable it to deliver public health policies.

Coming into line: the EU's Court softens on cross-border health care

The revolution started without anybody realising it. The finding, by the Court of Justice of the European Union (the Court), that two Italian nationals, Mrs Luisi and Mr Carbone, were entitled to travel to another member state to receive health services – unrestrained by capital movement or other restrictions – hardly alarmed people in the health sector: Luisi and Carbone were over-the-border service recipients paying, in private, for the services received. The drama unfolded over a decade later, when another over-the-border service recipient, Luxemburger this time, took things a step further: Mr Kohll sought to obtain a refund from his social insurance fund for treatment received abroad – and was found by the Court to be entitled to it. The great dismay of the health care sector did not stop the Court from going even further, holding that a system of prior authorisation (the standard practice to manage cross-border health care movements) could only exceptionally be tolerated, in relation to hospital treatments. The Court also held that, under some circumstances, patients could ‘force’ the delivery of an authorisation to go abroad. Over-the-border patients could even ‘make money’ from their social fund, if they could get an equivalent treatment more cheaply abroad. Subsequent judgments made clear that the right of patient mobility and the indispensable refund system should be made available by all health care systems, even where they are designed to offer primarily benefits-in-kind through taxation (Beveridge systems), rather than mere refund through social insurance (Bismarck systems). What is more, Beveridge systems have seen waiting lists, their core instrument for canalising health care expenses, brought under a case-by-case proportionality review. This revolution at the European Union level, however, has not led to the immediate transformation of national health care systems [on the process of transformation of national health systems, see Obermaier A., The End of Territoriality? The Impact of ECJ Rulings on British, German and French Social

How will Brexit affect health and health services in the UK? Evaluating three possible scenarios

The process of leaving the European Union (EU) will have profound consequences for health and the National Health Service (NHS) in the UK. In this paper, we use the WHO health system building blocks framework to assess the likely effects of three scenarios we term soft Brexit, hard Brexit, and failed Brexit. We conclude that each scenario poses substantial threats. The workforce of the NHS is heavily reliant on EU staff. Financing of health care for UK citizens in the EU and vice versa is threatened, as is access to some capital funds, while Brexit threatens overall economic performance. Access to pharmaceuticals, technology, blood, and organs for transplant is jeopardised. Information used for international comparisons is threatened, as is service delivery, especially in Northern Ireland. Governance concerns relate to public health, competition and trade law, and research. However, we identified a few potential opportunities for improvement in areas such as competition law and flexibility of training, should the UK Government take them. Overall, a soft version of Brexit would minimise health threats whereas failed Brexit would be the riskiest outcome. Effective parliamentary scrutiny of policy and legal changes will be essential, but the scale of the task risks overwhelming parliament and the civil service.

European Law and New Health Technologies

1. European Law and New Health Technologies: The Research Agenda PART I: SETTING THE SCENE 2. The Defining Features of the European Unions Approach to Regulating New Health Technologies 3. Fixed Points in a Changing Age? The Council of Europe, Human Rights, and the Regulation of New Health Technologies 4. Mapping Science and New Health Technologies: In Search of a Definition A Regulators Perspective PART II: LEGAL APPROACHES TO EUROPEAN LAW AND NEW HEALTH TECHNOLOGIES 5. Innovative Tissue Engineering and Its Regulation: The Serach for Flexible Rules for Emerging Health Technologies 6. Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Healthcare 7. Exclusions in Patent Law as an Indirect Form of Regulation For New Health Technologies in Europe 8. New Health Technologies and their Impact on EU Product Liability Regulations A Regulators Perspective A Regulators Perspective PART III: REGULATORY THEORY, REGULATORY INNOVATION, EUROPEAN LAW AND NEW HEALTH TECHNOLOGIES 9. Risk, Legitimacy, and EU Regulation of Health Technologies 10. Something Old, Something New, Something Borrowed: Emerging Health Technologies and the Continuing Role of Existing Regulations 11. Science, Law, and the Medico-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy 12. The Governance of Therapeutic Nanoproducts in the European Union: A Model for New Health Technology Regulation? A Regulators Perspective PART IV: NEW TECHNIQUES FOR RESEARCHING EUROPEAN LAW AND NEW HEALTH TECHNOLOGIES 13. Taking Technology Seriously: STS as Human Rights Method 14. Novel Rights Approaches to Health Technologies 15. Sociotechnical Innovation in Mental Health: Articulating Complexity 16. Where the Wild Things Are: Xenotechnologies and European Hybrid Regulation 17. When Sperm Cannot Travel: Experiences of UK Fertility Patients Seeking Treatment Abroad A Regulators Perspective PART V: BRINGING IT ALL TOGETHER Conclusion: A European Law of New Health Technologies?

Reducing harm from alcohol

The UK must tackle the problem of cheap alcohol

Thirty Years of EU Sex Equality Law: Looking Backwards, Looking Forwards

As I write, the Equal Pay Directive 75/117/EEC celebrates its thirtieth birthday. The fact that the body of law in which I research and teach mandates that I should receive equal pay to that which a man would receive for writing this editorial is something to celebrate! And, of course, the Equal Pay Directive represented only a modest beginning. The Directive, coupled with the ruling of the European Court of Justice in 1976 in Case 43/75 Defrenne No 2, was a significant catalyst for what is now a complex and multilayered EU law and policy in the field of sex equality. EU law has had wide-reaching effects in this regard in the Member States. EU sex equality law has developed through Court-made legal norms, legislation, and ‘new governance’ mechanisms. This is an opportune moment to assess the development of that body of legal norms, its contribution and its promise, in the context of an enlarging and constitutionalising European Union. In this special edition, members of the European Commission’s Network of Legal Experts on the Application of Community Law on Equal Treatment of Men and Women, and other invited expert contributors, reflect on the achievements of the EU’s sex equality law. They critically analyse recent developments and future prospects, offering strategies for reform. The contributors represent a range of national backgrounds, including Member States that joined the European Union in its latest geographical enlargement. The contributions were originally presented at an Expert Seminar in the Hague in November 2004. The seminar was organised in part as a challenge to a growing assumption that sex equality is somehow ‘completed’, if not in society, at least in EU law, and that we should instead focus our attention on the other non-discrimination grounds articulated in Article 13 EC. The contributors to the Seminar, and to this special edition, show that this is not the case, and that there is great potential for mutually beneficial

Reflecting on ‘Supporting health systems in Europe: added value of EU actions?’

Many in the health policy community are highly critical of the European Union and its involvement in health. Clemens et al’s paper is a refreshingly balanced analysis and assessment. It summarises the ‘standard narrative’ of the detrimental impacts of EU law and policy on national health systems. But it also illuminates an important counterbalance of ‘hidden’ aspects of EU health policy. These have the potential to improve health across the EU, even in the post-crisis era of public spending austerity. The conclusion – that on balance ‘EU involvement can add biases and problems previously unknown at national levels’ (Clemens et al, 2014) – is thus more persuasive than that in other analyses.

‘All About that Bass’? Is Non‐Ideal‐Weight Discrimination Unlawful in the UK?

People of non-ideal-weight (overweight or severely underweight) are subjected to discrimination, in the workplace and elsewhere, based on attitudinal assumptions and negative inferences from their membership of a group, such as that they are insufficiently self-motivated to make good employees. But is that discrimination unlawful in the UK? The Equality Act 2010 offers only a very tenuous route for protection, because the Act is based largely on a ‘medical model’ of disability. EU law, which embraces a ‘social model’ of disability, drawing from the UN Convention on the Rights of Persons with Disabilities, offers more, at least in theory. But the mechanisms for enforcing individual EU law rights mean that entitlements in EU law are likely to be enforceable in practice only against state employers. This situation leaves a gap in the law which is remediable only by legislative reform.