Paving the Road to Negligence: The Compensation for Research-Related Injuries in Spain

Abstract

The planned reform of the regulation of clinical trials in Spain has reopened the debate over how to regulate research-related injuries. Act 29/2006 and Royal Decree 223/2004 regulate the insurance of research-related injuries, and they include a general clause requiring mandatory insurance and imposing a no-fault compensation system; they also contain an exception clause enabling clinical trials to be carried out without insurance under some conditions, and an exclusion clause excluding compensation when there is no causal connection between injuries and a clinical trial. National legislation is under review, affecting the requirement of mandatory insurance and paving the road to a liability system based on negligence, which will affect the level of protection of the persons enrolled in clinical trials because it would not ensure compensation. Regulatory texts on individuals’ participation as research subjects should include not only mandatory insurance, but also a no-fault compensation system for cases when voluntary research subjects are injured, irrespective of negligence.

Keywords:

• biomedical research
• clinical trial
• damage insurance
• liability insurance
• negligence
• no-fault compensation
• research-related injuries

ACKNOWLEDGMENTS

The author is member of the research project “El Tiempo de los Derechos” [Human Rights Age], Consolider-Ingenio 2010 Program (CSD2008-00007). The author wishes to thank Richard Ashcroft, Marc Stauch, David Resnik, and the reviewers for useful comments and support on early versions of this paper.

Notes

1. Ley 29/2006, de 26 de Julio, de Garantías y Uso Racional de los Medicamentos y Productos Sanitarios. Boletín Oficial del Estado num. 178, July 27th, 2006, pp. 28122–28165. Available online at www.boe.es/buscar/doc.php?id=BOE-A-2006-13554. Last accessed May 6, 2014.

2. Real Decreto 223/2004, de 6 de Febrero, por el que se Regulan los Ensayos Clínicos con Medicamentos. Boletín Oficial del Estado num. 33, February 7th, 2004, pp. 5429–5443. Available online at www.boe.es/diario_boe/txt.php?id=BOE-A-2004-2316. Last accessed May 6, 2014.

3. Directive 2001/20/EC of the European Parliament and the Council, of 4 April 2001, on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medical Products for Human Use. Official Journal of the European Communities, May 1st, 2001, L 121/34 – L 121/44. Available online at eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF. Last accessed May 6, 2014.

4. Proyecto de Real Decreto por el que se regulan los Ensayos Clínicos con Medicamentos, los Comités de Ética de la Investigación con Medicamentos y el Registro de Estudios Clínicos. Available online at https://www.msssi.gob.es/normativa/docs/Rdensayosclinicosm.pdf. Last accessed May 6, 2014.

5. Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medical Products for Human Use, and reapealing Directive 2001/20/EC. Available online at http://ec.europa.eu/health/human-use/clinical-trials/#rlctd. Last accessed May 6, 2014. The new clinical trials regulation was approved on April 2, 2014, by the European Parliament; on April 14, 2014, was formally adopted by the European Council of Ministers; was signed into law on April 16, 2014; and on May 27, 2014, was published in the Official Journal of the European Union, L 158/1 – L 158/76. Available on line http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2014:158:TOC. There are not substantial changes.

6. Sentence of the Supreme Court, Civil Division, Section 1st, sentence number 758/2005, October 21^st, RJ 2005/8547.