Brosset, Estelle; Mahalatchimy, Aurélie --- "EU law and policy on new health technologies" [2017] ELECD 581; in Hervey, K. Tamara; Young, A. Calum; Bishop, E. Louise (eds), "Research Handbook on EU Health Law and Policy" (Edward Elgar Publishing, 2017) 197

Book Title: Research Handbook on EU Health Law and Policy

Editor(s): Hervey, K. Tamara; Young, A. Calum; Bishop, E. Louise

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781785364716

Section: Chapter 8

Section Title: EU law and policy on new health technologies

Author(s): Brosset, Estelle; Mahalatchimy, Aurélie

Number of pages: 25

Abstract/Description:

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.