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The Spanish Law on Assisted Reproduction

13 March 2006
By Dr Anna Veiga
Scientific Director of Reproductive Medicine Service, Institut Dexeus and Stem Cell Bank Director, Centre for Regenerative Medicine, Barcelona, Spain.
Appeared in BioNews 349
When the first law on assisted reproduction was approved in Spain in 1988 (Law 35/88), very few countries had legislation concerning the use of assisted reproductive technologies (ART). That law allowed controlled activity in the field, and most of the professionals involved found it appropriate at that time. However, as technical advances are arising constantly in the treatment of infertility, a change in the law was necessary.

The law was first modified in November 2003 (Law 45/2003), to clarify the fate of unclaimed surplus frozen embryos, and to avoid the creation of more surplus embryos. Before the law was approved, supernumerary embryos neither wanted for treatment nor for donation to other couples could be donated for research, or destroyed by the couples that generated them. Any embryo created after the modification of the law could only be used for reproductive purposes, although frozen embryos created before this time could still be used for research.   

The other modification involved limiting the number of eggs to be fertilised, to avoid the accumulation of surplus frozen embryos. Only three eggs could be used and all the embryos had to be replaced. However, circumstances in which more eggs could be fertilised were determined by a Royal Decree, and in practice, most ART centres put no limitation on the number of eggs fertilised.

After the government changed, from the conservative party to the more liberal current one, an overhaul of the entire legislation governing ART was initiated. The new law has already been approved by the Congress and is now at the Senate, for final approval. The new text considers the possibility of research with human embryos and the development of new methodologies and treatments. Frozen embryos created either before or after the law was changed in 2003 can now be donated for research. The creation of embryos for research is banned, and carries a penalty of 1-5 years in prison. Any new technique can be adopted once scientifically and clinically evaluated, and there is no limitation on the number of eggs that can be fertilised.

Reproductive cloning is prohibited and therapeutic cloning is not mentioned as it will be considered in the Biomedicine Law, currently under discussion and expected soon. It seems that nuclear transfer to obtain human embryonic stem cell lines for research and future therapies will be allowed under strict control, as in other European countries such as the UK, Sweden and Belgium.

Another important aspect of the law is the creation of a national registry of the centres performing ART, detailing their activities and their results. Such a registry is already in use in Catalonia, allowing an accurate analysis of both the number of cycles performed as well as success rates. This information will be made available to couples seeking treatment.

The creation of a registry for gamete donors is also considered in the new law. A donor can only produce six children in this way, to avoid consanguinity problems. All donations have to be anonymous, as they were in the previous law, which represents an important difference with other legislations in the European Union (EU). As a consequence, a number of couples from countries where no gamete donation is allowed - as well as couples seeking treatment with an anonymous donor - are travelling to Spain to be treated. Egg and sperm donors receive an economic compensation for their donation, and Spain currently carries out more treatments with donated gametes than many other EU states.

It must be pointed out that neither social sex selection nor surrogacy is permitted in the new law. One important change in the application of PGD (preimplantation genetic diagnosis) has been introduced, to allow the selection of embryos based on Human Leucocyte Antigen (HLA) type, to establish pregnancies that would allow treatment of ill children with cord blood or bone marrow transplants from compatible brothers or sisters. This technique was forbidden before, and couples had to look for treatment in other countries, when needed. 

The field of ART is constantly evolving, with new advances leading to more effective treatment of infertility. Legislation that takes these changes into account is vital for constantly improving results in this field. The text of the Spanish ART legislation adequately meets the needs of both the patients and the professionals involved, and this new law places the country with others in the EU that have a more liberal legal status.

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