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The Requirement of Industrial Application

Marta Díaz Pozo

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Clemens M Rieder

As EU Health Law and Policy is often seen as a creation of courts, rather than legislatures or executives, Clemens Rieder investigates the roles that national courts and the CJEU have played in the unfolding of EU Health Law and Policy. Rieder considers the implications of both actual litigation, and the ‘shadow of litigation’, which may indeed be more important. The relationships of the CJEU with national courts, the governments of the Member States and the European Court of Human Rights in Strasbourg are all crucial institutional contexts for the development and future trajectory of EU Health Law and Policy. The preliminary reference procedure grants the CJEU legitimacy, but ultimately leaves control in the hands of national courts. Member States also enjoy a horizontal dialogic relationship with the CJEU, where both actors have influence. The ECtHR may be of growing importance in the coming years.

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André den Exter

The exponential growth of electronic communication and exchange of medical data has changed and will continue to change the course of medicine in a wide variety of ways. The possibility of speed and long-distance communication means information (including confidential information) can pass very swiftly from country to country. André den Exter explores the way in which eHealth and mHealth interact with EU law on cross-border relationships; considering the use of electronic prescriptions; cross-border access to electronic records; and deployment of apps dealing with medicine and lifestyle choices.

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Johan W van de Gronden and Catalin S Rusu

Johan van de Gronden and Catalin Rusu investigate the extent to which EU competition law and policy may improve, or worsen, the efficiency of national health systems. The application of EU competition law to the behaviour of powerful market actors, such as the pharmaceutical industry, (social) health insurance providers or hospital chains, certainly has the potential to do so. But this may be at the cost of health-specific values.

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Tomislav Sokol and Nikola Mijatović

The ongoing Eurozone crisis has dominated discussion of the EU for several years, and has raised questions about its future, with many accusing the EU institutions of sacrificing social values on the altar of fiscal rigour. Tomislav Sokol and Nikola Mijatovi_ examine the effects the Eurozone crisis has had on national health systems. An overview of Eurozone economic governance rules precedes an analysis of their dramatic effects on access to healthcare, free movement of healthcare professionals and regulation of medicines. The chapter shows how differential application of fiscal governance rules to different Member States undermines the solidarity on which European health systems are based.

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Jean V McHale and Aurélie Mahalatchimy

Unlike regulation on the use of animal materials, the use of human materials in the EU is not regulated by one specific Regulation or Directive, despite a common legal base in public health, and common regulatory problems across the legal regimes for human tissues and cells, human blood and blood components, and human organs. Jean McHale and Aurélie Mahalatchimy consider the following: what is the legal classification, and consequently the applicable legal regime for human materials? How does EU law ensure their quality and safety for human applications? How does EU law facilitate access to human materials? What ethical questions do human materials raise and how does EU law manage them? McHale and Mahalatchimy conclude that the patchwork regulatory regime leaves a lack of consideration for important ethical concerns.

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Estelle Brosset and Aurélie Mahalatchimy

Estelle Brosset and Aurélie Mahalatchimy consider both EU pharmaceuticals and medical devices law, as new health technologies may occupy either space, even though a separate body of EU law and policy, with its own logics, has developed for each. Beyond the new unitary European patent, the International Stem Cell case left a complicated precedent, with a need for legal definitions at pace with current scientific reality as well as ethical dialogue with civil society groups in Member States. Furthermore, while there is increased regulation and marketing of Advanced Therapy Medicinal Products, and regulatory improvements offered by the European Commission, the products themselves remain far from patients.

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Marcus Pilgerstorfer

Marcus Pilgerstorfer considers how EU regulation and litigation based on EU health law interact in the case of pharmaceuticals, leaving uncertainties in the legal position with potential policy implications. The chapter considers some principal interactions between the EU’s regulatory regime for medicinal products, and its system of civil liability for defective products – focusing on marketing authorisation, labelling and advertising, post-market obligations and the Product Liability Directive.

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Ellen Kuhlmann, Claudia B Maier, Gilles Dussault, Christa Larsen, Emmanuele Pavolini and Marius-Ionuț Ungureanu

Ellen Kuhlmann and others explain the effects of EU Health Law and Policy on health professionals. Drawing on new empirical data, they show how the EU’s free movement law, combined with its fiscal disciplines, have challenging effects on sustainability of healthcare systems. Professional mobility is based on the logic of individual rights and opportunities for health professionals, which clashes with the population-based logic of healthcare systems when health professionals are free to move – reducing accountability and draining a country of a qualified medical workforce. While some improvements have been made, notably through the Working Time Directive, moves in this area are still framed in terms of labour market policy, which lacks the ability to overcome market-based logics, rather than the solidary basis of health policy.

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Markus Frischhut and Scott L Greer

Communicable disease control is a long-standing policy area, growing in importance the more human beings and other disease vectors are able to travel long distances and across borders. Individuals, governments and international organisations all affect the transmission and control of communicable diseases. Despite the EU being a relatively late entrant into the history of communicable disease policy, its influence in communicable disease policy, and, latterly, law, reflects broader dynamics in European integration. EU communicable disease policy and EU law lead to social and political spillover, which itself leads to further integration. EU communicable disease law and policy is particularly entwined with the ‘precautionary principle’.