Spain to allow human embryo research

Email: Xavier Bosch - xbosch@teleline.es
News from The Scientist 2003, 4(1):20030731-03

Published 31 July 2003

Spain is to become the first Catholic country in Europe to authorize research on human embryos to obtain stem cells. On July 25, the cabinet approved reforms of an outdated law on human assisted reproduction, one of the consequences of which will be to allow research on human embryos stored at in vitro fertilization (IVF) clinics.

The new law will be similar to those in place in Holland and Finland, which ban therapeutic cloning but permit research on spare embryos as long as parents provide appropriate consent.

The existing Spanish law on assisted reproduction, which dates back to 1988, forbids research on human embryos and states that spare embryos will be frozen for up to 5 years. But, as the law does not specify what should happen to embryos stored for more than 5 years, advocates of embryo research have been lobbying to amend the law to permit such research.

In 1998, the National Commission of Human Assisted Reproduction, a Health Ministry advisory body, released a report (only recognized by the ministry on July 25, 2003) recommending an amendment of the 1988 law to allow researchers to obtain stem cells from embryos stored for more than 5 years.

But the government, run by the right-wing Partido Popular party, has opposed the use of human embryos for research; last year, Prime Minister José Maria Aznar expressed moral concerns over such research.

In February 2003, the Advisory Committee on Ethics, which was created last year to advise the Ministry of Science and Technology, delivered a report backing research on "old," spare embryos. This report, and its agreement with the 1998 report, is regarded as the turning point in the reforms announced last week.

The reforms will enter the parliament in September for approval (a formality, as the Partido Popular has an overwhelming majority) and will take effect by the end of the year. They allow for the creation of a National Center of Transplants and Regenerative Medicine, to supervise all research and ethical issues surrounding human embryos in Spain. The center will implement a registry of Spanish facilities holding frozen embryos and will eventually grant any cell lines to authorized researchers.

This center—whose statutes will be approved within the next 6 months—will also house a national cell line bank to manage and store all lines created from spare embryos. More details about the center and the bank will be disclosed over the next few months; both will be funded by the Health Ministry.

All Spanish IVF clinics will have to report data regarding their frozen embryos to the bank within 2 months after the law takes effect. The number of frozen embryos currently stored in Spanish centers is estimated to range between 35,000 and 200,000.

Between now and when the law takes effect, any embryos up to 14 days old, regardless of how long they have been frozen, can be used for research, provided the parents give their informed consent. Where couples have donated their embryos for use by another couple, these embryos will remain available for donation for 5 years and will then be transferred for research to the national center. And if the parents—or the mother—are unknown and/or an informed consent has not been provided within a year, embryos will remain available for donation to other couples for up to 4 years, then be transferred for research.

But the situation will be totally different after the law takes effect. All embryos supplied after that point will remain frozen "throughout the full fertility period of the woman." Also, the law states that women wishing to become pregnant via IVF can receive a maximum of three embryos per cycle of treatment, and that only three eggs can be fertilized per cycle. Health minister Ana Pastor said the reforms are aimed at permitting research, preventing large numbers of spare embryos from accumulating in clinics, and reducing the numbers of multiple pregnancies.

César Nombela, president of the Advisory Committee on Ethics and a microbiologist at Complutense University of Madrid, applauded the government's decision and said, "It's gratifying to hear that the proposal put forward by this committee is the one that's most acceptable from a scientific and social point of view."

According to human reproduction expert Anna Veiga, head of the IVF area of the Dexeus Institute and a former member of the National Commission of Human Assisted Reproduction, this is "very good news" for Spain. She added, "we have been awaiting the reform of this law for a long time… it was a pioneering law at the time but is totally outdated now."

But the Socialist party—the main opposition—disagrees with the measure. Jaime Lissavetzky, who is responsible for the party's science commission, told The Scientist that although the reform is a positive step, it is a "law of no-return," for stored embryos. Once the law takes effect, there will be no further embryos for research, he said.

Lissavetzky agrees that during the next few months many cell lines could be created but said that his party plans to prepare an alternative law for consideration in parliament.



References

1.  [http://www.msc.es]
  Health Ministry
Return to citation in text: [1]
 
2.  [http://www.msc.es/salud/epidemiologia/ies/repro_asistida/resumen_anual.htm]
  National Commission of Human Assisted Reproduction: 1998 report
Return to citation in text: [1]
 
3.  [http://www.fecyt.es/en/info_estructura_ing.asp]
  Advisory Committee on Ethics of Scientific and Technical Research at the Spanish Foundation for Science and Technology
Return to citation in text: [1]
 
4.  [http://www.mcyt.es]
  Ministry of Science and Technology
Return to citation in text: [1]
 
5.  [http://www.fecyt.es/publi_comite.asp]
  Advisory Committee on Ethics of Scientific and Technical Research, Report: Stem cell research, February 2003. (Descargar.pdf)
Return to citation in text: [1]
 
6.  [http://www.ucm.es/]
  Complutense University of Madrid
Return to citation in text: [1]
 
7.  [http://www.idexeus.es/]
  Dexeus Institute
Return to citation in text: [1]
 


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