ART Regulations in Russia and Elsewhere

IV International Congress, Current Assisted Reproductive Technologies Issues: Problems and Solutions (2007)

Author: Svitnev K.N.

Based on ART Regulations in Russia and Elsewhere, monograph by K.N. Svitnev to be issued at the end of 2007.

If you met a pregnant woman having 8 children, out of which three were deaf, two were blind, one was mentally disabled and the woman herself had syphilis, would you recommend her to have an abortion? If yes, you just killed Ludwig Van Beethoven.

Your answer "No" to a person who has asks you for assistance in having a child is a similar murder. Any unrealized human life which could have been realized is a missed chance to change the world to the better and make people happier.

The right to continue the family line, or the reproductive right, refers to the fundamental human rights. Reproductive right is a range of universal human rights and liberties providing for realization of the basic inalienable human right to continue the family line, regardless of the age, gender, nationality, marital status or health condition, including the right to use assisted reproductive technologies, i.e. donor or surrogate programmes, as well as the right to individual family planning, including the right to determine the number and gender of their children and the time intervals between their birth.

The people's reproductive rights should be legally protected and their realization directly depends on the state support. In many case the reproductive rights of people may be realized only through the use of assisted reproductive technologies and the persons who possess such technologies - the reproduction (fertility) specialists. With the development of ART in the world there appeared a great number of people (who in most cases, unfortunately, have no relation to ART ТВ the fertility problem at all) who are actively discussing and forcing on the society their subjective opinion regarding immoral nature and inadmissibility of certain reproductive methods.

Under the pressure of such moralists deciding whether other people should or should not have children the lawyers in many countries feel simply lost. And this is understandable, as the wide possibilities opening to the humanity in the sphere of the ART are just breath-taking. People have always been afraid of the unknown - and in some countries the prohibitive approach to ART prevailed. This is Italy, first of all. The law No. 40 dd 19.02.04 accepted in Italy (The Regulations Relating to Medically Assisted Reproduction) prohibits the donorship of gametes and embryos, preimplantation diagnostics, cryopreservation of embryos (all the received embryos, and there might be no more than three of them, shall be implanted into the biological mother) and the surrogate motherhood. The fertility doctors services are available only to married couples. The breaches of the above entail penalties up to 300,000 Euro.

The Order of the Italian Minister of Health prohibits export of the embryos and gametes abroad. The operations of the Italian reproduction centers has been, therefore, successfully paralyzed. For the three years the number of Italian couples who have tried in vitro fertilization abroad has grown nearly fourfold: from 1,066 to 4,173 (pursuant to survey of 27 clinics in Spain and Belgium, as well as the USA).

The situation in Germany where since 1990 the Embryonenschutzgesetz Law (On the Protection of the Embryo) is in force is none the better. Use of the donor embryos and oocytes is prohibited. Sperm donorship is allowed, except for anonymous donorship. One cycle includes fertilization of up to three oocytes, and they all should be transferred to a biological mother. De facto, cryopreservation of embryos is also prohibited - there is no material left for cryopreservation. The choice of the gender is allowed, but only on medical grounds. This law prohibits surrogate motherhood, as "contradicting human dignity" and "humiliating the woman". For non-compliance imprisonment up to three years is provided and ruinous penalties. It should be noted, that unlike in Italy the parents ordering the programme and the surrogate mothers are not penalized.

As per Adoptionsvermittlungsgesetz, the Law on Adoption Mediation (§6, p. 4) which in force as of 1989, mediation in search of surrogate mothers and parents or any advertising thereof is prohibited. All these unfair prohibitions resulted in flourish of the "reproduction tourism" - every year a minimum of 1,000 German families go abroad, mainly to the USA, to have children their.

By the way, in Germany where the assistance to childless couples is prohibited due to its immoral nature, the prostitution has been legal since 2002, and the sex services are subject to VAT and the municipal tax. The sex market turnover amounts to 5% GDP. The comments are superfluous.

Similar laws are in force in France. Three years in prison and a penalty up to 45,000 Euro is provided for "mediation in bearing a child for another person" and "simulation derogating the civil status of the child". ART in France can be used only by the officially married couples or couples co-habiting for over two years.

Planning its entry to the European Union, Turkey prohibits cryopreservation of gametes, donation of gametes and embryos and the surrogate motherhood. The fertility services may be used only by couples are under 35 who are officially married.

Great Britain, Belgium, Greece and Spain are doing comparatively well, as the laws are much more liberal there. But a real oasis for the fertility doctors are the CIS countries, namely Russia, the Ukraine, Belorussia and Kazakhstan, where the law-makers proceed from the fact that the reproductive rights of people do not need thought-out limitations, but need legal protection and state support.

The ART regulations are extremely actual with regard to the declining demographic situation in Russia. Law is the most important demographic policy instrument. Four thousand years ago the Sumerian country faced a serious demographic crisis. To ensure "absolute growth of births", the Hammurabi Code of 1781 B.C. - the first law code known to the humanity - stated that the infertile wife wishing to have children should, for the purpose of continuing the family line, give to her husband a slave, and the children to which such slave gave birth would be the legal children of the childless couple. This scenario was used in all the three Old Testament programmes for "traditional" surrogate motherhood - in the families of Abraham and Jacob, his grandson.

Out of 42 million Russian families 47% do not have children. In Russia there are 10 million infertile people of reproductive age - 4 million men and 6 million women, and at least 15% (approximately 5 million) couples can not have children due to health conditions. Only three million can have children, if treated appropriately. Thus, around 3 million couples of reproductive age may become parents only through surrogate motherhood, i.e. bearing of a child for another family by a surrogate replacing mother, often in combination with different donorship programmes.

Russia needs new people. Instead of giving financial impetus to having children to those who can have children but do not wish to do so, the state should consider the needs of tens of thousands people who want to have children, but for one reason or the other do not have the chance to have them, and realize their reproductive rights in practice. The absolute growth of births can be provided by the following legal measures which do not require any financial investments on the part of the state:

1. Provide equal access to reproductive technologies for all people who want to have children.

  • It is commonly believed that a single woman may not use the surrogate mother services. This is not so. A single woman, as provided by Section 36 of The Fundamental Principles of the RF Law on Health Protection, is entitled to fertilization in vitro and implantation of embryo. If she has medical grounds for surrogate maternity, as provided for in the RF Ministry Order No. 67, she may also use the surrogate mother services for bearing her child. After birth of the child she should be recorded in the child's birth certificate as its mother. This record may be made after receipt of consent from the surrogate mother to such record.

    Single men of reproductive age (by 2005 there were 13 million of such men in the country) are deprived of the access to reproductive technologies and, as result, of the right to have children and their own family. This is an obvious breach of several RF Constitution articles, specifically, article 7 (that in Russia state support is provided to both maternity and paternity), article 19 on equal rights of men and women) and article 55 (on inadmissibility of laws derogating human rights). Single men wishing to have children should have access to surrogate motherhood programmes - gestational (in vitro fertilization with the donor ovum) or traditional (artificial insemination of the surrogate mother).

  • Pursuant to the RF Ministry of Health Order dd 26.02.03 N 67 On Application of Assisted Reproductive Technologies (ART) in the Treatment of Female and Male Sterility - the main document setting forth the procedure for application of the ART in Russia - the surrogate mother services may be used strictly on the basis of serious medical grounds. The really existing social grounds, when the physically healthy woman can not, due to certain objective or subjective reasons, afford bearing a child, are not covered in the Order. But the result, irrespective of whether the reason is physiological or social, is the same - the woman is infertile. It is necessary to change this situation and allow tens of thousands of women to have children.

  • Many fertility specialists think that the surrogate mother services in Russia are available only to married couples. But p. 4 of Section 51 of the RF Family Code does not state that the couple using the surrogate motherhood services should be married. The marriage s only one of the conditions for making the record of parents in the birth register - similar to adoption, when the persons not legally married can not adopt one and the same child. In any case, this restriction is irrelevant, as no law can prevent people from having a common child without marriage (by the way, over 400,000 children are born out of marriage in Russia every year).

    Let us consider the example of Belorussia (leave alone the American experience) in the sphere of ART - there the marriage of the parents is of no importance whatsoever. As per Article 53 of the Belorussian Family Code the mother of the child born by a surrogate mother is its genetic mother, and the father is the spouse of the genetic mother. In case the genetic mother is not married to the father of the child, the paternity shall be established pursuant to their joint application.

  • Now the situation is abnormal in what concerns AIDs or hepatitis C infected people. They can not realize their reproduction programmes in Russia, as many clinics do not undertake to work with them. In Europe, however, thousands of healthy children have been born from infected parents in the recent years - especially valuable in this respect is the German experience.

2. Improvement of the Current Legislation for Fuller Realization of Human Reproductive Rights

  • The traditional - and the most widely spread in the world - surrogate programmes with insemination of the surrogate mother are hardly realizable in Russia, as p. 4. of Section 51 of the RF Family Code and Section 15 oа the Federal Law On the Civil Status Rights refers only to the fertilization in vitro and the couple using artificial insemination of the surrogate mother may not be registered as parents in the birth certificate. De jure, this is a common gestational surrogate programme with the donor ovum, where the donor is the surrogate mother itself.

    "Traditional" surrogate programmes can be a real way out for the hundreds of thousands of poor childless couples who can not afford the complicated and expensive in vitro fertilization with the use of the donor ovum.

  • Russia refers to the countries where the principle "the mother is she who has given birth" works to the full extent, and the surrogate mother has all the rights to the child she bears. As per p. 4 of Section 51 of the RF Family Code, "a married couple who have given written consent to implantation of embryo to another woman for the purpose of bearing thereof may be registered as the child's parents only upon consent of the woman who has given birth to the child (the surrogate mother)". This provision impeding wider use of the surrogate programmes in treatment of infertility should be altered.

    Thus, in the Ukraine the lawyers chose a more logical and correct approach. The new Family Code (p. 2 of Section 123) specifies that the couple who have given their consent to the use of ART enjoy to the full extent the parents' rights and obligations towards the children who have been born as result of the use of such methods. P. 3 of this Section provided for the use by the parents of donor oocytes, and the embryo in any case will be deemed as originating from the parents. Similar laws are in force in Kazakhstan and Belorussia - the surrogate mother may not leave the child she bears to herself. In 2004 in Kazakhstan the Law on the Human Reproductive Rights and the Guarantees of their Realization" was accepted which, in spite of certain dubious provisions, in p. 4 of section 17 sets forth explicitly that "the surrogate mother may not refuse to transfer the child born by her to the persons who have entered into agreement with her, or transfer the child to third parties". The similar laws were accepted in Belorussia in July 2006. As per Section 53 of the new Belorussian Family Code, "the mother of the child born by the surrogate mother is its genetic mother". A precondition for surrogate motherhood programmes in Belorussia and Kazakhstan is entering into an agreement on surrogate maternity which should be certified by the notary on a mandatory basis. In the Ukraine as well as in Russia the notarial certification of the surrogate maternity agreement is not required.

    It seems expedient to use the progressive foreign experience in this case, specifically American experience. America is one of the most conservative and purist countries in the world. Nevertheless, America became the pioneer in the new legal field relating to ART and the surrogate motherhood. There are states where the surrogate maternity (more exactly, the surrogate contracts or surrogate mediation) are prohibited. There are states which are a real land of promise for thousands of childless couples from all over the world. First of all, this is Arkansas. The surrogate mother services contract is binding here, the parents (or parent), i.e. the hiring party to the contract, are registered in the birth certificate of the child born by the surrogate mother without any delay. Fairly enough the law considers the intent of the "hiring" parents resulting in appearance of the surrogate child to be of primary importance when deciding on the parents of the surrogate child. Thus, the very possibility of emergence of any disputes or battles over the child is eliminated. In case several years after the birth of the child the parents get divorced, the court, when deciding with whom the child will live, proceeds not from the biological parentage (if any), but from identifying with whom it will be better for the child to stay.

    This state is a Mecca for single parents. Both single men and women can hire surrogate mothers for continuation of their family.

    Exceptionally progressive in this regard are the laws of California and Florida. California courts delivered several crucial judgments which changed the legal situation in this state and many other states. Historical became the judgment in the case Johnson v. Calvert in 1993, when for the first time in the world's legal practice the INTENT of the client woman to BECOME the mother and to bring up the child born by the surrogate mother was acknowledged as the key issue determining the maternity in the gestational surrogate programmes. According to the adjudication, Johnson who bore the child was the "baby-sitter, to which the parents entrusted their child for a while". The court especially underlined that the use of donor oocytes is in no way an obstacle to acknowledging the hiring woman's maternity.

    Another landmark was the famous case of Jaycee Buzzanca. An infertile couple from California, John and Luanna Buzzanca, hired a surrogate mother forbearing a child conceived in vitro with the donor sperm and the donor oocyte. In March 1995, six days prior to Jaycee's birth, John filed for divorce - motivating his desire to get divorced by the fact that there were no children born from their marriage. He did not want to bear any obligations towards Jaycee and did not acknowledge his paternity. The court ruled that the newly borne Jaycee had no parents. The girl having three fathers (the sperm donor, the husband of the surrogate mother who gave birth to her and the hiring husband) and three mothers (the oocyte donor, the surrogate mother and the hiring wife) was declared an orphan and placed under Luanna's custody. For four years she was an orphan until a higher court acknowledged that her legal parents are the Buzzankas, as she came to life due to them. The ruling was based on p. 7610 of the California Family Code, which defines the consent of the woman to "the medical procedure resulting in pregnancy and birth of the child" as the proof of maternity. Luanna legally became a mother, and John had to pay the alimony.

    In the special comments dedicated to the traditional surrogate maternity when the surrogate mother is at the same time the biological mother of the child she bears, the court noted that the intention of the hiring mother to bring up the child prevails over the biological maternity of the surrogate mother.

    As per the court's decision in the case Dunkin v. Bosky the couples not legally married have the same rights as the legally married ones when using the surrogate programmes.

  • The law shall provide for the possibility to change the date and place of birth of the surrogate child for the purpose of keeping this fact secret - similar to the existing adoption practices.

  • Taking into consideration the declining environmental conditions and the risks arising out of manmade disasters, in Russia it is essential to create gamete and embryo banks for all people who are not ready to have children now, but wishing to realize their reproductive right in the future. In each case the will of the client of such bank shall be documented - who and what may be done with their gametes and embryos, including in case of their death.

    The Israel experience is interesting, where delivery of sperm by soldiers is a common practice. With the help of the surrogate mothers over 10 "afterdeath" children have been born. It is planned to take the sperm from all the dead soldiers within six hours of their death.

    The first surrogate maternity programme with the use of the sperm from a dead biological father ended in November 2005. Ten years ago Andrei Zakharov had to undergo a course of chemotherapy in Israel. Before the treatment, as recommended in such cases, submitted his sperm for cryo-preservation. The therapy did not work and in eight years Andrei died without leaving any children. His mother set the birth of a grandson as the goal of her life. The doctors of Yekaterinburg Family Center helped her to realize her dream. The frozen Andrew's sperm was transferred to Yekaterinburg where the gestational surrogate programme with the use of the donor ovum took place. In 9 months Ekaterina Zakharova had a healthy grandson. To say that the grandmother faced serious problems when registering the child is to say nothing. He was not acknowledged as her grandson, courts and civil registration bodies thought that the only relative of the child is the surrogate mother who gave birth to the child. In this case the refusal to register Ekaterina Zakharova as the grandmother was illegal. The following legal scheme should have been applied here: establishment of paternity through court - as per Section 49 of the RF Family Code - the application of the person on whom the child depends is enough, and the court should take into consideration any authentic evidence proving that the child originates from a particular person. After determination of paternity Ekaterina Germanovna would be automatically acknowledged as the grandmother.

    "Afterdeath" reproduction programmes should not be outside the legal frames in Russia as they are today.

    American association of fertility doctors recommends to be careful working with the "afterdeath" gametes and embryos, though it does not object to it, if so is the wish of the diseased.

    In England and in France the afterdeath programmes are illegal. Thus, in 1996 some Ms Blood was refused to get inseminated with the sperm of her dead husband. The widow was disallowed to take the sperm to Belgium where such practice is quite legal. At that, Ms Blood could use any sperm of the anonymous donor, but not of her untimely deceased own husband.

3. Remove Artificial Limitations for Women Wishing to become Surrogate Mothers

Pursuant to the requirements of earlier mentioned Order 67 of the RF Ministry of Health, a woman of certain age - from 20 to 35 - who has already had her own child may become a surrogate mother.

It would be more logical to let the parents themselves determine who will bear their child. The practice shows that the surrogate mothers often become - absolutely for free - the nearest relatives of the infertile parents, which considerably reduces the cost of the surrogate programme. Well-known is the first surrogate programme among the relatives realized in the South Africa Republic in 1987 when the 48-year-old Patricia Antony successfully carried and gave birth to her three grandsons for her 25-year-old daughter.

Removal of the age limitations would significantly increase the number of successfully realized programmes. Not very rich couples would gladly cut down their costs at the expense of the surrogate's mother fee.

The requirement to have own child also limits the number of potential surrogate mother. The vicious circle appears - a woman has no money to have her first baby and she has no conditions for brining it up, so she decides to bear a child for another couple, but she is refused by the clinics, as she first has to give birth to her own child. It is necessary to change this situation and give childless women a chance to have their own child through participation in a surrogate programme for another couple.

4. A burning question is acceptability of preimplantation diagnostics for the purpose of selection of the gender of the future child.

In Russia pursuant to the requirements of the Order of the RF Ministry of Health dd 26.02.2003 No. 67 this procedure may be applied only pursuant to the medical grounds - in case of risk of birth of a child with mutation of any isolated gene or chromosomal anomalies. At that, this Order allows reduction of pregnancy, i.e. a similar destruction of embryos which have been considered "unnecessary". Abortion is not legally prohibited and is a common practice in Russia and any other countries. If the law reserves the woman's right to optional interruption of pregnancy, then, to be consistent, why can't the parents refuse to have embryos of the unwanted gender prior to pregnancy due to the same social reasons?

This is the way it is done in the USA. From October 2005 the American reproductive clinics can use the PGD technology to select the gender of the child in accordance with the parents' desire who would like to have a second child of another gender. In England selection of the gender is still prohibited, though cancellation of this law is actively discussed.

The right to continue the family refers to the basic and inseparable natural human rights. Everything which helps a new person to come to this world is ethical and acceptable. Everything which impedes it is immoral and unacceptable. Based on this principle, our lawyers have developed a draft of the Law on ART and the Guarantees of Human Reproductive Rights.

We invite all the fertility specialists who are present to take part in the discussion of this draft law before submittal thereof to the specialized State Duma Committee (October 2007). To obtain the law draft text, please register on our site.

With regard to the international experience, Russian law-makers should support, on the state level, rather than limit all people who would like to have their own children with the help of the ART. Presently, the situation is abnormal, when even the simplest questions are ignored by the law-makers. Here are some of them:

  • Does the embryo have the right to life, and from what age?
  • Does the surrogate mother have the right to retain the child born by her?
  • What would be with the embryo if one of the parents dies?
  • Can the frozen gametes be used in case of death of their owner for further realization of the surrogate or reproductive programmes?
  • Can the frozen embryos be used in case of divorce or death of one of the parents?
  • What should be done in case of divorce or death of the parent of the child borne by the surrogate mother?
  • Can surrogate mothers be used on social grounds?
  • How to implement reproduction programmes for single parents?
  • What should be done with unused embryos and gametes and can they be used for fundamental investigations?
  • Can embryos be created for investigation purposes?

In the current legal Russian vacuum in this area nobody wants to take responsibility for implementation of non-traditional reproduction programmes. But the science always goes ahead of the society - the scientists leave the lawyers and the politicians behind. The science creates new opportunities never dreamt of before. We should not be afraid of such opportunities.

According to different sources, since the 25th of July 1978, when Luisa Brown was born - the first in-vitro child (by the way, we ask you to support our initiative in declaring this day, starting from the next anniversary year, the professional holiday for all reproduction specialists) - from one to 3 million children conceived in vitro have been born. In Russia only 30,000 have been born. In the small Israel there are over 100 reproduction clinics, while in Russia for the entire one hundred forty-five million people there are only 40 clinics.

A state assistance programme for childless people who need to use in vitro fertilization is required. Now the situation is starting to change to the better. The Duma Health Protection Committee is working at the Population's Reproduction Health Programme. For the first time in Russia it is planned to allot 15 billion rubles per annum for in vitro fertilization, i.e. the country plans to pay for the in vitro fertilization. Such practice is common for a range of foreign countries. Thus, in Germany the insurance companies reimburse all the expenses relating to in vitro fertilization. In Italy infertility treatment is fully state-financed, while in Finland only 50% is covered by the state. In Austria the state pays for 6 attempts, and in Hungary and Denmark for 3 attempts. There is one idea behind it - the state, to some extent or the other, finances the reproductive programmes for its people. In Russia the mandatory medical insurance today does not cover the expenses for infertility treatment - while abortions are financed through the insurance.

The cost of three in vitro fertilization attempts (this is usually enough for the pregnancy) in Russia amounts to 250,000 rubles - and this is the sum by which the state wants to motivate the women already having children to have more. I think it would be more logical - and practical - to allot this money for the poor childless couples who want to participate in vitro fertilization programmes. A considerable plus here is that as result of in vitro fertilization twins or triplets are born in over half of cases.

According to some estimates, in two years liberalization of the existing reproduction law can give the country up to one million of additional births a year - without any financing from the state. State financing of the reproduction programmes may change the entire demographic situation in Russia.

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С 1 августа 2007 года компании "Росюрконсалтинг" присвоен статус представительства Союза Юристов Москвы.

Юристы компании разработали проект закона "О вспомогательных репродуктивных технологиях и гарантиях репродуктивных прав граждан". Приглашаем специалистов, а также широкую общественность принять участие в обсуждении этого законопроекта.

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