The Spanish government made it easier for embryonic stem cell research to be undertaken in the country last week when it approved a decree that clarifies the country’s regulations for the use of embryos in research.
Embryo research has been permitted in Spain since July 2003, when the previous government approved legislative reforms related to human assisted reproduction. The changes allowed research on embryos leftover from in vitro fertilization (IVF) treatments, but did not include specific mechanisms for permitting scientists to apply to undertake projects.
That problem was resolved on October 29 by a Royal Decree approved by the new Socialist government, which provides a framework for granting authorization for embryo use as well as setting out requirements for corresponding embryo studies.
“It is necessary and essential research. What is not ethical is to put obstacles to scientists who are working to cure diseases,” said Deputy Prime Minister María Teresa Fernández de la Vega in a press briefing after the cabinet meeting.
Under the regulations, embryos created by IVF will only be available for research use if they have been frozen for more than 5 years and if the couple involved explicitly authorizes their use for this purpose. Couples who chose to allow their embryos to be used in this way will sign an informed consent form and grant permission for a specific research project. They will not be eligible for remuneration and will have not rights to subsequent patents.
The new regulations state that embryo research will be coordinated by the Instituto de Salud Carlos III, the research agency of the Health Ministry, which has already guaranteed €100 million to fund projects.
Applications for research projects will have to mention which embryos are going to be used and will have to confirm that “the same results cannot be obtained with research animals.” Any future cell lines must be registered in a national stem cell bank and made available on a nonprofit basis for other projects, the government said.
This week, the Health Ministry said it will create a national commission to follow-up on and control projects, which will be headed by Francisco Gracia, director of the Instituto de Salud Carlos III. This way, said Health Minister Elena Salgado at a Madrid press conference, “it is guaranteed that uniform and homogeneous criteria are applied for the trials.”
The Catholic church in Spain criticized the move. “The production of human beings in the laboratory is ethically unacceptable. It is seriously illicit and unjustifiable, even with therapeutic goals, to use these embryos to reanimate and then kill them for the obtention of stem cells,” according to the Episcopal Conference, made up of the top officials of the Spanish Catholic church.
But Health Minister Salgado went as far as to state that next year, when the government approves a new Biomedical Research Law, “therapeutic cloning may be included if that is the feeling of society.”
Salgado pointed out that the reform approved last week is still somewhat constrained by limitations of the law approved last year by the former government. When the new biomedical law takes effect, there will be no need to use only embryos frozen for more than 5 years, and the clause in the trial application form that “the same results cannot be obtained with research animals” will be likely eliminated.
Researchers suggested embryonic stem cell research could now begin quickly. Jordi Camí, director of the new Barcelona Biomedical Research Park, told The Scientist that research with embryonic stem cells will probably begin at the new Center of Regenerative Medicine by the end of the year.
María Jesús Montero, head of the Health Department of the Andalusian government, said in a statement that the Karolinska Institute has already shipped embryonic stem cell lines to Granada’s Cell Lines Bank, so that research in that new center can “start without delay.”
