European Information Network - Ethics in Medicine and Biotechnology

Predictive Genetic Diagnosis

--- Overview Spain ----

- Ethical discussion -

There is no country specific discussion.

- Legislation -

(Author: Staff from Inter-University Chair in Law and the Human Genome, Spain)

The first Spanish regulation on Predictive Genetic Diagnosis was passed in 1988. Most of the European laws about this subject came later, during the nineties. Spanish ethicist and lawyers criticized these laws because of being exceedingly permissives. All fertility techniques known at that time were authorized, also the performance of predictive genetic diagnosis, gamete and embryo donation was admitted, single women could ask for anomymous sperm, only surrogate motherhood was forbidden.

These laws was adopted in a context of progressive legistures that adopted new principles in medicine and family matters. The Spanish bio-laws of the eighties wanted to encourage research and development of bio-medical sciences in the country.

The Constitutional Court interpreted that these laws did not conflict with the constitution.

Besides these laws on biomedicine, the new Penal Code (1995) regulated a new section relating to crimes about genetic manipulation, which includes some crimes about reproductive medicine. Notwithstanding, it doesn«t regulate Predictive Genetic Diagnosis.

In conclusion, the regulation passed in 1988 is insuffiente to face the new challenges of reproductive medicine. Many European laws dating to the nineties, have already been reformed (this is the case in Denmark, Sweden and France) but the Spanish Parliament has not reached the consensus required to change the law.

In the other hand, the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, of 19 November 1996, was signed by Spain, so today is part of our regulation since January 2000 and in this Convention are also regulated Predictive Genetic Diagnosis.

Links

(Collected by: Staff from Inter-University Chair in Law and the Human Genome, Spain)

Ethics
There are no ethical links.

Legislation

• Ley 35/1988, de 22 de noviembre sobre Técnicas de Reproducción Asistida ( assisted reproduction techniques Act) [as pdf-document]
• Ley 42/1988, de 28 de diciembre, de donación y utilización de embriones y fetos humanos o de sus células, tejidos u órganos (Donation and use of the embryos and foetus, or their cells or organs Act) [as pdf-document]
• Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, of 19 November 1996
• Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. (Patient´s righs and obligations Act) [as pdf-document]
• Ley 16/2003, de 28 de mayo, de cohesión y calidad del Sistema Nacional de Salud. BOE 29 de mayo de 2003, núm. 128, pp. 20567. (National Health Sistem Act)
• Real Decreto 412/1996, de 1 de marzo, por el que se establecen los protocolos obligatorios de estudio de los donantes y usuarios relacionados con las técnicas de reproducción asistida y se regula la creación y organización del Registro Nacional de Donantes de Gametos y Preembriones con fines de reproducción asistida. BOE 23 de abril de 1996, núm. 72, pág. 11253. (Royal Decree on Information and control of gametes and preembryo´s donors)
• Real Decreto 413/1996, de 1 de marzo , por el que se establecen los requisitos técnicos y funcionales precisos para la autorización y homologación de los centros y servicios sanitarios relacionados con las técnicas de reproducción humana asistida. BOE 23 de abril de 1996, núm. 72, pág. 11256 (Royal Decree on Requirements of the centres in which are performed assisted reproduction techniques)
• Real Decreto 415/1997, de 21 de marzo, por el que se crea la Comisión Nacional de Reproducción Humana Asistida BOE 22 de abril de 1997, núm. 70, pág. 9419 (Royal Decree on National Commission on Human Assisted Reproduction)
• Real Decreto 120/2003, de 31 de enero, por el que se regulan los requisitos para la realización de experiencias controladas, con fines reproductivos, de fecundación de ovocitos o tejido ovárico previamente congelados, relacionadas con las técnicas de reproducción asistida. BOE 15 de Febrero de 2003. (Royal Decree which regulate the autorization of controlled experiences with reproductive aims. These experiences investigate the fecundation of ovocites or ovaric tissue previously frozen) [as pdf-document]

Further

• Tribunal Constitucional. Sentencia de 20 de Diciembre de 1996. Recurso de insconstitucionalidad contra la ley 42/1988, de 28 de diciembre, de donación y utilización de embriones y fetos humanos o de sus células, tejidos u órganos. (Constitutional Court opposite to this law 42/88).
• Tribunal Constitucional. Sentencia de 18 de Julio de 1999. Recurso de inconstitucionalidad contra la Ley 35/1988, sobre técnicas de reproducción asistida (Constitutional Court opposite to this law 35/1988).
• Department of Public Heath (Information about Centres and Registrers on Assisted reproduction)