Research Handbook on EU Health Law and Policy
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Research Handbook on EU Health Law and Policy

Edited by Tamara K. Hervey, Calum A. Young and Louise E. Bishop

The steady expansion of the European Union’s involvement in health over the past 20 years has been accelerated by recent events. This handbook offers an up-to-date analytical overview of the most important topics in EU health law and policy. It outlines, as far as possible, the direction of travel for each topic and suggests research agenda(s) for the future.
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Chapter 8: EU law and policy on new health technologies

Estelle Brosset and Aurélie Mahalatchimy

Abstract

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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