THE HEALTH OF THE UNION (workshop)

Legal Issues of Economic Integration, 2011

This paper looks at European Union (EU) biomedical law and seeks to understand how the regulation of biomedicine ever reached the EU’s agenda. The odds were low, for not only does the EU not have any straightforward competence in the field, it is also one of extreme axiological sensitivity that in all likelihood could have favoured the containment of the issues within national borders. To be sure, internal market legislation is not alien to non-market values; conversely, biomedical issues themselves are undergoing radical evolutions as body parts tend to increasingly circulate in what now appears to be ‘tissue economies’. Although these factors alone do not suffice to explain the existence and development of an important body of biomedical law at the EU level, the paper’s claim is that ‘ethics’ has proven to be an instrumental device for bridging biomedical law and EU law. It then analyses the several manners in which ‘ethics’ has played a crucial part in EU biomedical law and pushe...

In this chapter I focus on the EU's emerging biomedical research law and policy and examine the development of citizen science in this setting. The chapter argues that while what the analysis reveals might not be specific to the EU, attention to this organisation underlines important but often overlooked aspects of citizen science. That is, citizen science is (being) made less about promoting substantive involvement by citizens in the fashioning of biomedical trajectories and their empowerment as participants that pursue aims defined by themselves rather than others. Instead citizen science is underpinned by a more longstanding EU level approach to participation in science-based issues that sees it being harnessed, shaped and directed towards supporting the production and legitimation of organisational identity and sociotechnical order (in this case the EU’s). Within biomedical research law and policy citizen science might therefore be expected to support market-optimised biomedical futures and a dynamic internal market and economy. Citizen science is thereby implicated in the delineation of the boundaries of responsibility and accountability (and blame) for the (non-)realisation of public health priorities and objectives. In this way law and policy on participation and citizen science might support current research trajectories that do not serve all health needs.

Journal of Medical Ethics, 2013

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union (EU). Methods Web searches were performed from September 2009 to January 2011. Notes on predetermined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010. Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees (RECs) in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries. Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future.

EMBO reports, 2011

The health of European medical research Attempts are under way to update EU regulations, with the aim of harmonizing clinical research across the continent Philip Hunter surgery and medical devices, Hartmann added. He explained that the European Commission now considers medical devices and drugs as 'products' that can be sold in the internal market, and therefore require a common and harmonized regulatory framework.

Health Economics, Policy and Law, 2020

The relevance of the European Union (EU) for health has been widely recognised within the health community for some time, and is increasingly apparent to European policy-makers and publics. Despite being an area of policy that national governments would prefer to keep exclusive control of, and though in the past it has rarely been at the top of the agenda, many elements of health have been gradually ‘Europeanised’. This special issue marks the culmination of a British Academy-funded project – EU Health Law and Policy: Shaping a Future Research Agenda – which sought to build on the growing web of expertise in this field and reflect upon the future of health as an EU competence, at a time when it appeared to be under threat.

Jahr - European journal of bioethics, 2011

Bioethics is always described as implying a multidisciplinary and pluralistic approach of the issues encompassed. No doubt that the law and lawyers have deeply contributed to its origin and present development. However, conversely to the United States, it seems that bioethics has opened some new perspectives to the law in Europe. First, it forced the law to move out of its own frontiers and to apply its reasoning to life sciences issues with the consequence that some consider that the legal norms are used to legitimate unlawful practices while others believe legal norms have imposed binding conditions to the free development of science and technology. Second, Europe is the only region of the world where biomedical techniques are subjected to legal and sometimes binding harmonisation. In some way, we may conclude that the role played by the law in the elaboration of European bioethics is just an example of the important role of the law in the European integration.

The return on investment in medical research are enormous for society, and proper funding for medical research in Europe will lead to better health, welfare and economic prosperity. We hope that this White Paper will lead to a debate followed by actions to create improved conditions for medical research in Europe, and thereby secure for European patients and citizens the benefits from significantly improved health and welfare in the future.

2017

PART 4: PUBLIC HEALTH 4. Chapter 15: EU public health law and policyon the rocks? A few sobering thoughts on the growing EU alcohol problem PART 5: THE EXTERNAL DIMENSION 5. Chapter 17: Trade and health in the European Union 6. Chapter 18: The EU's (emergent) global health law and policy CONCLUSIONS 7. Chapter 19: The impediment of health laws' values in the constitutional setting of the EU 1 For further information, see N Azzopardi-Muscat and others, 'The impact of the EU Directive on patients' rights and cross border health care in

Legal Studies, 2005

How does the law of the European Union affect health law and policy? At first sight, the impact of EU law in this area seems limited. However, despite its restricted formal competence, over recent years, the EU has become increasingly involved in the health field. Litigation based on EU law has resulted in a 'right to receive health care services' across national boundaries within the EU, which may have huge practical implications for national health systems.The EU has promulgated legislation regulating clinical research, and the marketing of pharmaceuticals; patients' rights are affected by EU legislation on data protection and product liability; the qualifications of health care professionals are legally recognised across the EU; and the EU has acted to promote public health. The authors of this book (expert in EU law and health law respectively) seek to explain and explore the various impacts of measures of EU law on national health law and policy. Through elaboration of selected examples, the authors show that, within the EU, health law cannot be regarded as a purely national affair.

Health Policy, 2007

The overall purpose of this article is to analyze whether these ratifying EU Member States have fulfilled their obligation provided for in article 1 of Section 2 of the Convention ("each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention"). We further explored the legal consequences of ratification of the Convention. We analysed for each ratifying Member State whether and how the ratification of the Convention has influenced patient rights legislation and policies. Finally, we concluded by dividing the 11 Member States into 4 categories depending upon the already existing patient rights legislation at the moment of ratification and the constitutional provisions related to the ratification of an international treaty in general in a given Member State.