Chapter 2 - Community intervention in the field of health and the European regulation of clinical trials on medicinal products for human use

Article type: Research Article

Authors: De Angelis, Paolo

Affiliations: Alma Mater Studiorum, Università di Bologna, Bologna, Italy. E-mail: [email protected]

Abstract: The European Union organisation, which was established to regulate the relations of economic nature, has expanded its scope, including among its objectives the protection of the citizen fundamental rights; this is a result of the evolving case-law of the Court of Justice pursuant to the information contained in the Charter of Nice and the Treaty of Lisbon. Only from the early 70's health policies have begun to affect community entities, especially since carriers through which contribute to achieving the four main freedoms expressed in community legislation. On April 16th 2014 regulation No 536/2014 on clinical trials on medicinal products for human use was adopted by the European Parliament and the Council. As can be seen from reading the text, the target of the regulation is to ensure the robustness and reliability of data on clinical trials throughout the Union, while guaranteeing respect for the rights, safety, dignity and well-being of the subjects. The European regulation is at the heart of a contrast between two different wishes that the EU, the regulation seeks to combine: on one hand, the need for the EU to remain an attractive place to conduct clinical trials. And on the other hand, the need to ensure respect for the rights, safety, dignity and well-being of those involved in clinical trials.

Keywords: EU intervention in healthcare, regulation No 536/2014 on clinical trial, European right to health protection

DOI: 10.3233/PPL-160418

Journal: Pharmaceuticals Policy and Law, vol. 17, no. 3-4, pp. 297-325, 2015