TY - JOUR

T1 - An EU Comparative Analysis of the Regulation of Clinical Trials Supervisory Bodies in the Aftermath of Regulation 536/2014

AU - de Miguel Beriain, Iñigo

AU - Chortara, Theodora

AU - Duardo-Sánchez, Aliuska

AU - Feeney, Oliver

AU - Felzmann, Heike

AU - Fernández de Uzquiano, Emma

AU - Lievevrouw, Elisa

AU - Marelli, Luca

AU - Mattsson, Titti

AU - Rothmar Herrmann, Janne

AU - Minssen, Timo

AU - Pulice, Elisabetta

AU - Raposo, Vera Lucía

AU - Robienski, Jürgen

AU - Penasa, Simone

AU - Van Hoyweghen, Ine

N1 - Funding Information: Conversely, in countries such as Denmark or Portugal, there are differences according to the type of committee involved. In Denmark, regional committees are financed by the regions and the national committee is financed by the Ministry of Health and Elderly (§1 Executive Order no. 1159 and §40 Executive Order no. 1083). In Portugal, the members of the Ethics Commission for Clinical Research (CEIC) are part of the National Institute of Pharmacy and Medicines (Infarmed) staff, thus, it could be said that Infarmed is funding a part of the supervision of clinical trials. However, CES’s are funded by the health unit in which they are located. Funding Information: Iñigo de Miguel Beriain is an Investigador Distinguido. Chair in Law and the Human Genome RG, University of the Basque Country, Universidad del País Vasco/Euskal Herriko Unibersitatea (UPV/EHU). Leioa. Spain. Iñigo de Miguel’s research for this article was supported by the Government of the Basque Country. Grant IT-1066-16 and Research Professor. Ikerbasque. Basque Foundation for Science. Bilbao. Spain and by the EU Commission, Horizon 2020 Science with and for Society Programme (H2020 SWAFS) Programme, PANELFIT Project, research grant number 788039. Email: inigo.demiguelb@ehu. eus. Theodora Chortara is M. Bioethics, Member of the Laboratory for the Research of Medical Law and Bioethics of Aristotle University of Thessaloniki, Greece; Aliuska Duardo-Sánchez is PhD in Law. University of the Basque Country, UPV/EHU. Leioa. Spain; Oliver Feeney is PhD in Political Philosophy and Bioethics, Centre of Bioethical Research and Analysis (COBRA), National University of Ireland (Galway), Republic of Ireland; Heike Felzmann is PhD. Lecturer in Philosophy & Ethics, Centre of Bioethical Research and Analysis (COBRA), National University of Ireland (Galway), Republic of Ireland; Emma Fernández de Uzquiano is PhD in Pharmacy, MBioethics. Head of the Technical Secretariat of the Drug Research Ethic Committee, Hospital La Paz, Madrid, Spain; Elisa Lievevrouw is based at the Life Sciences & Society Lab, Centre for Sociological Research (CeSO), University of Leuven, Leuven, Belgium; Luca Marelli is Senior Research Fellow with the Life Sciences & Society Lab, Centre for Sociological Research (CeSO), KU Leuven, Leuven, Belgium; Research Fellow (Visiting) at the European Institute of Oncology’s Department of Experimental Oncology, and Adjunct Professor of Bioethics at the Department of Medical Biotechnologies and Translational Medicine, University of Milan, Milan, Italy. L. M. has received funding from the European Union’s Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant agreement No 753531; Titti Mattsson is Professor of Public Law and Director of the Health Law Research Centre at Faculty of Law Lund University, Sweden; Janne de Miguel Beriain, Iñigo; Chortara, Theodora; Duardo-Sánchez, Aliuska; Feeney, Oliver; Felzmann, Heike; Fernández de Uzquiano, Emma; Lievevrouw, Elisa; Marelli, Luca; Mattsson, Titti; Rothmar Herrmann, Janne; Minssen, Timo; Pulice, Elisabetta; Lúcia Raposo, Vera; Robienski, Jürgen; Penasa, Simone & Van Hoyweghen, Ine. ‘An EU Comparative Analysis of the Regulation of Clinical Trials Supervisory Bodies in the Aftermath of Regulation 536/2014’. European Public Law 26, no. 2 (2020): 307–330. © 2020 Kluwer Law International BV, The Netherlands Funding Information: L. M. has received funding from the European Union's Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant agreement No 753531. I?igo de Miguel's research for this article was supported by the Government of the Basque Country. Grant IT-1066-16 and Research Professor. Ikerbasque. Basque Foundation for Science. Bilbao. Spain and by the EU Commission, Horizon 2020 Science with and for Society Programme (H2020 SWAFS) Programme, PANELFIT Project, research grant number 788039. Timo Minssen's research for this article was supported by the Novo Nordisk Foundation (NNF17SA0027784; CeBIL: Collaborative Research Program in Biomedical Innovation Law) Funding Information: Rothmar Herrmann is Professor in law, Faculty of Law, University of Copenhagen, Denmark; Timo Minssen is Professor of Law, Managing Director, Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), Denmark. Timo Minssen’s research for this article was supported by the Novo Nordisk Foundation (NNF17SA0027784; CeBIL: Collaborative Research Program in Biomedical Innovation Law); Elisabetta Pulice is PhD, Research Fellow in Comparative Public Law, University of Trento, Docteur en droit public, Université Paris Ouest Nanterre La Défense. France; Vera Lúcia Raposo is Associate Professor of the Faculty of Law of the University of Macau, China; Auxiliary Professor of the Faculty of Law of Coimbra University, Portugal; Jürgen Robienski is a Lawyer and also researcher at CELLS (Centre for Ethics and Law in the Life Sciences at Leibniz University of Hannover, Germany); Simone Penasa is Assistant Professor in Comparative Public Law, University of Trento and Ine Van Hoyweghen is Professor of Sociology. Life Sciences & Society Lab. Centre of Sociological Research (CeSO) KU Leuven, Belgium. Its application, however, will be delayed until the European Commission announces that an independent audit confirms that a fully functional EU clinical trials portal and database has been developed. To be more precise, the Regulation will become applicable six months after the publication of the notice of this confirmation. See para. 8 of the Regulation.

PY - 2020/6

Y1 - 2020/6

N2 - The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for the optimization of the trial supervision regime in the EU. Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance. On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis.

AB - The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for the optimization of the trial supervision regime in the EU. Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance. On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis.

KW - clinical trials

KW - ethics committees

KW - Regulation on clinical trials

KW - regulatory competition

UR - http://www.scopus.com/inward/record.url?scp=85100087714&partnerID=8YFLogxK

M3 - Article

AN - SCOPUS:85100087714

VL - 26

SP - 307

EP - 330

JO - European Public Law

JF - European Public Law

SN - 1354-3725

IS - 2

ER -