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IVF Rules and regulations in Spain

Officially Spanish regulation on Assisted Reproduction was passed into law in November 1988, Law 35/1988. Spain was the first country with a separate law only concerning this item.

Introduced this and further documents regulated the main important aspects of assisted reproduction techniques (ART) and established that some other aspects like the creation of a National Register and the constitution of the National Committee of Human Assisted Reproduction.
Below you will find some crucial points of Spanish ART law (source: http://www.seg-web.org/index.php/en/dernieres-nouvelles/89-analyses-scientifiques/88-spanish-regulations-on-assisted-reproduction-techniques) :

Assisted reproduction techniques have as their aim medical action against human infertility to facilitate procreation when other therapeutic methods have been rejected as inadequate or ineffective. These techniques may also be used in the prevention and treatment of diseases of genetic or hereditary origin, when it is possible to make use of them with adequate diagnostic and therapeutic guarantees, and provided that they are strictly indicated. Fertilization of human eggs for any purpose other than human procreation is prohibited by this law and by the Penal Code.
Any woman may be recipient or user of the techniques regulated by the present law, provided that she has freely knowingly and expressly given her written consent to the use of these techniques. She must be of eighteen or more years of age and of sound mind. A married woman must obtain her husband’s formal consent, unless she is legally separated or divorced, or separated de facto or by mutual consent.

Human assisted reproduction techniques must be performed by specialised teams in authorised centres only. The law and with more detail the Royal Decree 413/1996, describe the requirements for the institutions undertaking ART as well as the procedures to follow with the patients.

Sperm cryopreservation is allowed but sperm may be kept frozen in authorised banks for a maximum period of 5 years. Cryopreservation of oocytes will not be allowed unless their viability, once thawed, is guaranteed. The embryos not transferred in an in vitro fertilisation (IVF) and embryo transfer procedure will be cryopreserved in authorised centres for a maximum period of 5 years. Two years after they have been frozen, those gametes or embryos not obtained from donors shall be made available to the corresponding banks.

Donation of human gametes or embryos is a formal, free and secret contract between the donor and the centre. Under no circumstances will a donation be made for lucrative or commercial ends. Donation shall be anonymous. The medical team will select the donor. It must guarantee the maximum degree of phenotypical and immunological similarity and the maximum degree of compatibility with the recipient and her social environment. Details of the identity of the donor shall be kept in the strictest secrecy, and with access subject to security procedures in the respective Banks and in the National Register of Donors. In no case will the Civil Register reflect data from which the character of the birth may be inferred. Children born as the result of the use of these techniques have the right either personally or through their legal representatives, to obtain general information regarding the donors, excluding the donor’s identity. Recipients of gametes shall also enjoy this right. Under no circumstances will the donor be subject to legal claims of paternity. The Royal Decree 412/1996 and the Ministerial Order of 25.03.1996 establish the donor’s characteristics and the standard screening required against genetic, hereditary or infectious diseases transmission.

Gametes can be used for research purposes but after this, they must not be used to obtain embryos to be used in procreation. In vitro research on “viable embryos” will only be allowed in the case of applied diagnostic research seeking prevention or therapeutic ends and if the genetic inheritance is not modified. In vitro research with other ends than preventive or therapeutic ones will only be allowed with “non viable embryos”. Experimentation on embryos in the uterus or the Fallopian tubes is forbidden.
Notwithstanding any previous provisions, the husband shall be able to consent, by written public declaration or by will, that his reproductive material may be used in the six months following his death to fertilise his wife. Under these circumstances, the legal effects will be those derived from marital filiation.
No contract which provides for gestation, with or without payment, by a woman who renounces her maternal bonds in favor of the contractor, or of a third party, shall have any legal validity whatsoever. The filiation of children born by substitute gestation will be determined at birth.

The law establishes a list of serious and very serious infractions. The most important ones are detailed below.

  • The fertilization of human eggs for any purpose other than human procreation.
  • To obtain human embryos by uterine flushing.
  • To maintain live embryos after day 14, not excluding the cryopreservation period.
  • To mix semen from different donors or to use oocytes from different women for IVF or gamete intrafallopian transfer (GIFT).
  • To transfer gametes or embryos without biological guarantees of their viability.
  • To create identical human beings by using cloning techniques or any other procedure.
  • Sex selection or genetic manipulation for non-therapeutic or unauthorised therapeutic purposes.
  • To produce chimeras by embryo fusion or any other procedure.
  • To obtain hybrids by genetic interchange with other species.
  • To perform ectogenesis or to create an individual human being in the laboratory.

Embryos frozen for more than 5 years, exceeding the legal storage limit allowed. The CNRHA proposes to contact the couples in such situations and ask them for embryo donation to other couples if they do not have a parental project anymore. If contact is unsuccessful or both members of the couple have died, the embryos can be used for donation to other couples. If there is any circumstance that does not allow donation (advanced maternal age, increased genetic risk, more than 6 children born, etc.) the embryos have to be destroyed. To adopt these measures, a transitional period should be established.

The new assisted reproduction law introduces new therapeutic options that could benefit certain specific cases. Among them is the possibility, with prior authorisation, of having a Preimplantational Genetic Diagnosis combined with determination of histocompatibility of antigens with therapeutic ends for third parties. This new technique will make it possible to solve the problem of families who have a child affected by some disease that requires a transplant of bone marrow or umbilical cord blood, which could possibly be cured by the birth of a healthy and compatible sibling. In the last few months, a number of requests for treatment have been made, but it has been impossible to find a solution up to now because of the legal prohibition that existed in this country.

Also, the new law allows the freezing of oocytes and ovarian tissue for reproductive purposes. This new possibility will make it possible to preserve fertility in certain cases in which this might be compromised, although permission will have to be obtained from the relevant health authority for their use.

The new law will resolve many of the difficult situations that have been faced up to now both by couples who use these techniques and by the professionals who work with them. This law will set out the new framework for action amending the controversial points and resolving some “legal vacuums” that were to be found in the previous rules.

The new law will change the maximum period for freezing oocytes and embryos, leaving this to medical judgement with no set limit. It also gives couples the power to decide on the future of their frozen embryos, giving the same options to all equally, irrespective of the date when they were frozen. Most of the couples who decide to keep frozen embryos go on to use them until they achieve their wish to become parents and many of them return for a second or third pregnancy. However, certain circumstances can arise that change the couple’s initial desire. Medical problems that rule out a new pregnancy or separation of the couple, for example, are possible reasons why couples do not transfer the frozen embryos. There was also the paradox that couples with frozen embryos before the law of November 2003 could choose between transferring them themselves, donation to third parties, donation for research, or destruction whereas couples with embryos frozen after this law could only have them used for reproductive purposes. It seems rather strange and unfair that a law can allow different rights to patients depending only on the date when the treatment took place. The possibility of using the surplus embryos for research projects when there is no parental desire on the part of the parents would allow Spain to develop its own lines of research, both for improving assisted reproduction techniques and in the field of stem cells.

This new law also removes the controversial limitation on fertilising only 3 oocytes (a restriction introduced by the November 2003 law). This limitation was a great hindrance for infertile couples as it substantially reduced their chances of success. It is important to recognise that if sufficient embryos are obtained in an in vitro fertilisation cycle for some of them to be cryopreserved for future attempts, the chances of having a child increase considerably. It is scientifically proved that the cumulative probabilities of pregnancy for a couple that undergo an IVF cycle rise from 35-40% to 65-70% if frozen embryos are available. Although Royal Decree 1720/2004, which followed the 2003 Law defined the exceptions in which it was not necessary to apply the limitation, most specialists in Assisted Reproduction were strongly in favour of removing the restriction and the new proposal under which the decision on the number of oocytes to be inseminated must be decided by agreement, taking into account the couple’s wishes and the medical judgement according to the special circumstances of each case.

The anonymous, altruistic and unremunerated nature of donations is maintained, though there are regulations on the financial compensation that is usually given to donors as compensation for physical inconvenience and travel. From time to time the Ministry of Health and Consumer Affairs, sets the criteria and financial limits for compensation, ensuring that these are not the only incentive for the donation.

This Law retains the prohibition on sex selection where there is no therapeutic indication, surrogate motherhood and reproductive cloning and includes a number of administrative penalties for breaking the law.

One important challenge of this new law is the setting-up of a Register of the results of the different assisted reproduction centres as well as Register of donors. The creation of this Register was foreseen in the first assisted reproduction law in 1988 but no government since then proved capable of setting it up.

It is of the greatest importance that the passing of this new progressive, yet respectful, assisted reproduction law should not be a momentary matter with none of the required regulations to allow it to be applied properly in all its aspects and, with the passing of time, to adapt it to new needs as they arise. To that end this law strengthens the advisory role of the National Assisted Reproduction Commission (CNRHA) and introduces the respective equivalent commissions of the Autonomous Communities as support and reference commissions of the CNRHA allowing them to co-operate with it in its work. The Catalan Advisory Commission on Assisted Human Reproduction Techniques was set up in 1993 and was the first commission of its kind in Spain. Over the years, the Catalan commission has advised the Catalan Health Ministry, moving forward and co-operating in a number of very important initiatives such as setting up the FIVCAT register or starting a pilot trial to provide financial assistance for IVF patients by paying for their hormonal medication. There can be no question, the wide experience that the Catalan commission has accumulated during these years will make a valuable contribution to the implementation and future development of the new Spanish Assisted Reproduction Law.

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