Regulation of stem cell research in Spain
Spain has a comprehensive regulatory framework for stem cell research, with a series of laws and regulations applied to different aspects of research.
Current legal position
The Law on Biomedical Research (Law 14/2007) allows for research on embryos for therapeutic and research purposes. The creation of embryos specifically for research is prohibited, as set out in this extract from the act’s preamble:
In accordance with the gradualist perspective on the protection of human life set out by our Constitutional Court in rulings such as 53/1985, 212/1996 and 116/1999, this Law expressly prohibits the creation of human pre-embryos and embryos exclusively for the purpose of experimentation. However, the use of any technique for collecting embryonic stem cells for therapeutic or research purposes that does not entail the creation of a pre-embryo or of an embryo exclusively for this purpose, and in the terms provided by this Law, is allowable.
In relation to the use of supernumerary embryos from assisted human reproduction techniques, the starting point is to be found in Law 14/2006, of May 26, on Assisted Human Reproduction Techniques, which expressly forbids so-called reproductive human cloning.
[“pre-embryo” in the context of this act refers to “an embryo constituted in vitro that is formed by the group of cells that are the result of the progressive division of the egg cell, from the time it is fertilized until 14 days after.”]
This act also regulates stem cell trials and other research involving humans (except clinical trials) and their biological samples, as well as the donation and use of embryos, cells, tissues and organs.
History
Law 35/1988, the first on assisted reproduction techniques in Spain, banned research on viable embryos unless for the purposes of diagnosing, treating or preventing disease in that embryo. This was modified by Law 45/2003, allowing for the donation of embryos for research. The current legislation, Law 22/2006, allows surplus embryos to be donated for reproductive purposes, towards a specific research project or disposed of without further use, subject to the informed consent of the embryo owner(s).
Ethical and regulatory oversight
There are two separate commissions with different functions in relation to stem cell research in Spain:
- Guarantees Commission for the Donation and Use of Human Cells and Tissues, established under the following law: Real Decreto 1527/2010, de 15 de noviembre, por el que se regulan la Comisión de Garantías para la Donación y Utilización de Células y Tejidos Humanos y el Registro de Proyectos de Investigación. http://www.boe.es/buscar/doc.php?id=BOE-A-2010-18654
- National Commission on Assisted Human Reproduction, established under Real Decreto 42/2010, de 15 de enero, por el que se regula la Comisión Nacional de Reproducción Humana Asistida. http://www.boe.es/diario_boe/txt.php?id=BOE-A-2010-1705
Relevant laws, policies and links
- Law on Biomedical Research 14/2007 of July 3, Ley 14/2007, de 3 de julio, de Investigación biomedical, Madrid: Boletín Oficial del Estado, at http://www.boe.es/boe/dias/2007/07/04/pdfs/A28826-28848.pdf
- Law on Assisted Reproductive Technology, Law 22/2006—Human Assisted Reproduction Techniques, LEY 14/2006, de 26 de mayo, sobre técnicas de reproducción humana asistida, Boletín Oficial del Estado, at http://www.boe.es/aeboe/consultas/bases_datos/doc.php?id=BOE-A-2006-9292
- Law on Assisted Reproductive Techniques, Law 45/2003 of 21 November, which it modifies the law 35/1988, of 22 November, Ley 45/2003, de 21 de Noviembre, Por la que se Modifica La Ley 35/1988, De 22 de Noviembre, Boletín Oficial del Estado, at http://www.boe.es/buscar/doc.php?id=BOE-A-2003-21341
- Law on Assisted Reproductive Techniques, Law 35/1988, Ley 35/1988 de 22 noviembre, Assista sobre Tecnicas de Reproduccion, Boletín Oficial del Estado, at http://www.boe.es/buscar/doc.php?id=BOE-A-1988-27108