The Spanish government has now formally approved a decree clarifying the country's laws on human embryonic stem cell (ES cell) research. The Spanish government passed legislation on assisted reproduction and embryo research in October 2003, but did not specify the mechanisms that would allow Spanish scientists to undertake research projects.
Speaking at a medical conference in September, Elena Salgado, the Spanish health minister, said that Spain would allow human ES cell research to take place from the end of October 2004. At the time, she said that the government was waiting for approval of its proposals on 'informed consent' from a consultative body. The proposals state the procedure that must be followed in order to ensure that patients understand what they are agreeing to when they participate in clinical tests.
Spain's laws state that embryos left over from IVF and donated by the couple that created them can be used in research, including ES cell research, if they have been frozen for more than five years. Couples must sign an informed consent form and grant permission for the specific research project their embryos are to be used in. Applications for research projects will have to detail which embryos will be used, as well as showing why it is necessary to use human, rather than animal, cells for the research. Any ES cell lines created must be registered in the national stem cell bank and made available to other researchers.
The Spanish health ministry said that it will create a national commission to oversee projects and follow them up. At a press conference, Salgado said that Spain's laws may be developed further in the future. Next year, when the government is expected to approve a new Biomedical Research Law, it may also be extended to include 'therapeutic cloning, if that is the feeling of society', she said. It may also remove the requirements that embryos be in storage for five years, and that researchers must show that they could not use animals. Spain's deputy prime minister, Maria Teresa Fernandez de la Vega, said 'it is not ethical to place obstacles and difficulties in the way of scientists who are using their talent and knowledge to improve our capacity to treat illness'.