Assisted reproductive technology: new legislative initiatives - Jurfem

Assisted reproductive technology: new legislative initiatives

Abstract. This text provides an overview of the legislative initiatives submitted by Ukraine’s members of parliament in January 2022 to regulate the use of assisted reproductive technology (Draft laws No. 6475-1, 6475-2, 6517, 6517-1) given the need to regulate the relations when using assisted reproductive technology, which will take into account the rights and obligations of all the subjects entering into these relations.

WILL THERE BE A LAW REGULATING THE USE OF ASSISTED REPRODUCTIVE TECHNOLOGY?

In December 2021, the Cabinet of Ministers of Ukraine registered Draft Law No. 6475 (concerning assisted reproductive technology), which is another attempt to regulate the relations that arise during the use of assisted reproductive technology. As of today, such relations are regulated by an order of the Ministry of Healthcare. At the same time, many experts in the field of reproductive health pointed out the shortcomings of this draft law and the need to take into account the provisions of alternative draft laws. In particular, concerns regarding Draft Law No. 6475 include: a discriminatory nature of the provisions preventing an unmarried woman from having access to assisted reproductive technology, the impossibility of using the surrogate motherhood method based on a criminal record; corruption risks when authorizing a doctor to determine the maximum age of a patient wishing to have access to assisted reproductive technology; risks if assisted reproductive technology is not publicly funded, etc.

WHAT ARE THE LEGISLATIVE INITIATIVES ALTERNATIVE TO DRAFT LAW NO. 6475 SUBMITTED BY THE MEMBERS OF PARLIAMENT ABOUT?

In January 2022, two draft laws alternative to Draft Law No. 6475 were registered in the Verkhovna Rada of Ukraine: No. 6475-1 (on the use of assisted reproductive technology) and No. 6475-2 (on the use of assisted reproductive technology and surrogate motherhood).

These draft laws offer their vision of legislatively enshrining the organizational and legal principles of assisted reproductive technology regulation, namely the conditions and procedure for the use of assisted reproductive technology, including the surrogate motherhood method, the rights and obligations of persons using assisted reproductive technology, the conditions and procedures for donating reproductive cells, disposal of reproductive cells.

Conceptually, the draft laws are similar in terms of their content and have a common goal – to legislatively regulate the use of assisted reproductive technology. However, the concept of Draft Law No. 6475-2 differs to some extent from the first alternative draft law, i.e. No. 6475-1.

We suggest focusing on the main differences between these draft laws, which are important when it comes to legal regulation of the use of assisted reproductive technology.

ARE THERE ANY CONTRAINDICATIONS TO THE USE OF ASSISTED REPRODUCTIVE TECHNOLOGY?

Thus, both draft laws emphasize the necessity to take into account medical contraindications when using assisted reproductive technology.

However, Draft Law No. 6475-1 does not specify a possible list of such contraindications. Moreover, the draft law does not emphasize any other restrictions on the use of assisted reproductive technology, both for women and for men.

But Draft Law No. 6475-2 provides that a list of medical indications and medical contraindications to the use of assisted reproductive technology is determined by the central executive body in charge of the formation and implementation of the state healthcare policy.

Moreover, Draft Law No. 6475-2 provides an exhaustive list of the categories of women and men who cannot use assisted reproductive technology (if they previously used assisted reproductive technology with the aim of having a baby, but later abandoned a new-born baby; they are deprived of parental rights, unless these rights have been restored; they abuse alcohol or drugs, etc.). However, there is concern about the fact a woman or a man, who, in particular, due to their health condition, requires being constantly looked after by others, cannot have access to assisted reproductive technology to treat infertility.

As we know, people who need to be constantly looked after by others can include persons with disabilities and patients who are not capable of self-care and need constant assistance of others. However, the draft law does not define the list of such diseases at all. Due to the fact that this provision concerns the use of assisted reproductive technology in a broad sense, and not only surrogate motherhood, we believe that the right of men and women who are infertile and have health problems to have their own children are unreasonably limited.

IS MEDICAL PRACTICE THAT INCLUDES THE USE OF ASSISTED REPRODUCTIVE TECHNOLOGY THROUGH SURROGACY SUBJECT TO LICENSING?

We believe that regulation of licensing of reproductive medicine clinics is extremely important and necessary for proper state control over the legality of their work. Thus, Draft Law No. 6475-1 proposes separate licensing for medical practice, which includes the use of assisted reproductive technology through surrogacy, as a result of which relevant Paragraph 15-1 will be added to Part 1 of Article 7 of the Law of Ukraine “On Licensing Business Activities”.

Instead, Draft Law No. 6475-2 does not require separate licensing being obtained by such institutions. By contrast, the draft law focuses on the prohibition of economic activities involving assisted reproductive technology through intermediaries (agencies).

It should be noted that the lawmakers do not provide a definition of the concept of “an intermediary (agency)” in the context of this Law, and, therefore, the consequences of enshrining this provision may be unpredictable. This is due to the fact that in the market for assisted reproductive technology services intermediary agencies can have a “shadow nature”, which does not lead to the protection of the rights and legitimate interests of persons for whom the help of special agencies can be extremely important.

All of this may contribute to the activity of a number of intermediary firms whose main goal is to earn profits rather than ensuring the rights of the parties to an agreement for the provision of assisted reproductive technology services.

We believe that limiting an opportunity for obtaining financial benefits from intermediary activities will help prevent the transformation of the use of assisted reproductive technology into commercial entrepreneurship.

Moreover, state control over organizations providing intermediary services of assisted reproductive technology may be considered acceptable.

WHAT ARE THE REQUIREMENTS FOR A WOMAN WHO CAN BE A SURROGATE MOTHER?

Draft Law No. 6475-1 does not provides for clear age limits for a woman planning to be a surrogate mother, and says that the maximum age of a surrogate mother is set by a doctor according to the results of her examination. It emphasizes exclusively that a surrogate mother can be an adult capable woman who has no medical contraindications for carrying pregnancy and childbirth and has given birth to a healthy child without congenital malformations.

However, Draft Law No. 6475-2 provides for a clear age range during which a woman can become a surrogate mother. Thus, a surrogate mother is to be a capable woman aged 21 to 35, who has no medical contraindications for carrying a baby and/or pregnancy and childbirth, has her own healthy child without congenital malformations and has given her written voluntary informed consent to medical intervention for the purpose of using assisted reproductive technology.

Previously, in its materials Analytical Center JurFem emphasized the expediency of establishing age restrictions for a woman who plans to be a surrogate mother.

HOW DOES THE LAWMAKER SEE A SURROGATE MOTHERHOOD CONTRACT?

Existence of a surrogate motherhood contract is another issue to be regulated by these draft laws.

Draft Law No. 6475-1 specifies that a contract must be concluded in writing. In addition, the essential terms of a contract are determined, including: the subject matter of the contract; the number of embryos that will be transferred to the uterus of the surrogate mother; designation of the health care institution, whose doctors will use appropriate assisted reproductive technology; the place of residence of the surrogate mother during the period of carrying the baby; actions of the parties in case of multiple pregnancy; the obligation of the genetic parents to accept the child if the baby is born with a genetic disease, congenital malformations or other diseases; actions of the parties in case of death of one or both of the spouses, their divorce; the amount of compensation to the surrogate mother for carrying and giving birth to a child; the procedure for reimbursing expenses for medical care, food, accommodation of the surrogate mother during the period of carrying a baby, childbirth and the postpartum period.

However, Draft Law No. 6475-2 contains a provision that a surrogacy service contract is concluded in writing personally by the parties to the contract and is subject to notarization. Along with this, an exhaustive list of essential terms of the contract is provided, which is much broader than in the first alternative draft law.

We believe that it is appropriate to impose a requirement specifically for the notarization of the surrogacy service contract and the development of a standard form of a contract for registering surrogacy relations.

CAN HUMAN REPRODUCTIVE CELLS, REPRODUCTIVE TISSUES AND EMBRYOS BE EXPORTED AND SOLD ABROAD?

Draft Law No. 6475-1 permits patients, business entities storing reproductive cells, tissues and embryos, and/or health care institutions to import reproductive cells, tissues and embryos into the customs territory of Ukraine and export reproductive cells, tissues and embryos from the customs territory of Ukraine on the basis of relevant statements of the owners of reproductive cells, tissues and embryos.

And the procedure for importing reproductive cells, embryos and tissues into the customs territory of Ukraine and exporting them outside this territory will be established by the Cabinet of Ministers of Ukraine.

By contrast, Draft Law No. 6475-2 stipulates that the transportation of reproductive cells, reproductive tissues and embryos within Ukraine, their storage, and import into the customs territory of Ukraine is carried out solely if there is the supporting documentation of health care institutions, in which infertility treatment is provided by using assisted reproductive technology or in which reproductive cells, reproductive tissues and embryos were obtained.

Reproductive cells, reproductive tissues and human embryos may not be exported and sold abroad.

As we can see, the aforementioned draft laws have fundamentally different positions on the issue of export and sale of reproductive cells, reproductive tissues and human embryos abroad.

WHO IS ALLOWED TO USE ASSISTED REPRODUCTIVE TECHNOLOGY BY THE SURROGATE MOTHERHOOD METHOD?

It is undoubtedly important to provide a list of necessary conditions for those who wish to use the surrogate motherhood services.

Draft Law No. 6475-1 stipulates that the use of assisted reproductive technology through surrogacy is allowed only for spouses (a husband and a wife) who are officially married.

In addition, it also emphasizes the need to comply with the following conditions:

– the husband (if the surrogate mother is officially married) of the surrogate mother gives his written consent and the authenticity of his signature is to be notarized;

– the patient has medical indications, due to which she is physiologically unable to carry  and/or deliver a baby or it puts the life and health of the patient and/or the baby at risk;

– a mandatory condition for the use of the surrogate motherhood method is the genetic connection of the future baby with the genetic parents (or with one of the genetic parents) and non-existence of the child’s genetic connection with the surrogate mother, unless a baby is carried, when using the surrogate motherhood method, by the family members of the genetic parents (grandmother, mother, sister, aunt, niece);

– the genetic parents must collect the baby from the health care institution where the birth took place after the baby is delivered and have this baby birth registered pursuant to the applicable laws of Ukraine.

Draft Law No. 6475-2 emphasizes that the surrogacy service is available only to a capable woman and a capable man who have been married for more than two years upon their written joint voluntary informed consent to medical intervention and the use of assisted reproductive technology, providing that the woman has medical contraindications to carrying and/or delivering a baby or she is physiologically unable to carry  and/or deliver a baby or it puts the life and health of the patient and/or the baby at risk.

At the same time, attention is drawn to the following conditions, which are necessary for using the surrogacy services:

– the surrogate motherhood service is available only to a capable woman and a capable man who have been married for more than two years;

– they married woman and man give their written joint voluntary informed consent to medical intervention and the use of assisted reproductive technology;

 – the woman has medical contraindications to carrying and/or delivering a baby or she is physiologically unable to carry and/or deliver a baby or it puts the life and health of the patient and/or the baby at risk.

As we can see, these alternative draft laws have in common one of the main requirements for a capable man and a capable woman: they have to be officially married. However, an important condition required by the lawmakers (Draft Law No. 6475-2) is that they have to be married for at least two years.

This issue is quite controversial because, on the one hand, the lawmaker thus intends to avoid fictitious marriages, but on the other hand, two years are quite a significant period of time postponed until the birth of a baby.

The only requirement that was common for both draft laws is that the woman (the patient) has medical contraindications to carrying and/or delivering a baby or she is physiologically unable to carry and/or deliver a baby or it puts the life and health of the patient and/or the baby at risk, which is undoubtedly an important condition that must be met by a woman who intends to use the surrogate motherhood services.

THE RIGHT OF FOREIGNERS AND STATELESS PERSONS TO USE THE SURROGATE MOTHERHOOD SERVICE 

As we know, in Ukraine the surrogate motherhood services are also available to foreigners as there is no ban on such services in Ukraine.

Draft Law No. 6475-1 provides that the Law extends, in particular, to foreigners and stateless persons legally staying in Ukraine. Also, foreigners and stateless persons may go to health care institutions for infertility treatment using assisted reproductive technology.

However, the specifics of the right of foreigners and stateless persons to use surrogate motherhood services have not been defined in any way.

However, Draft Law No. 6475-2 clarifies this issue and provides that a couple where both spouses are foreigners, a couple where one spouse is a foreigner and the other is a stateless person, can use the surrogate motherhood services if the use of this method of solving the problem of infertility is not prohibited by the joint personal law of the couple, if the spouses have no joint personal law – the law that determines the legal consequences of the marriage.

Moreover, this draft law provides that the central executive body being in charge of the formation and implementation of state policy on family and children, in the field of surrogacy, will keep records of foreigners wishing to use the surrogacy services in Ukraine and check the provided documents and information regarding the absence of grounds for denying such services to such persons.

And one of the mandatory documents for participation in surrogacy programs is a letter from the diplomatic mission or consular institution of the relevant state, confirming the absence of a ban on receiving surrogate motherhood services in the state, the right of which is determined by the common personal law of the spouses, and if the spouses have no joint personal law – the law of the state that determines the legal consequences of the marriage.

At the same time, these provisions of Draft Law No. 6475-2 provide, in turn, restrictions for foreigners and stateless persons in exercising their right to receive surrogate motherhood services due to the fact that the legislation of some countries of the world prohibits or does not regulate at all the use of the surrogate motherhood method.

ADVERTISING ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGATE MOTHERHOOD

Draft Law No. 6475-1 contains no provisions and mentions no restrictions when it comes to advertising the use of assisted reproductive technology and surrogate motherhood.

By contrast, Draft Law No. 6475-2 fundamentally emphasizes the prohibition of advertising the donation of reproductive cells and tissues, as well as any advertising aimed at engaging women in the provision of surrogate motherhood services.

However, in no way does this draft law provide for liability of individuals violating the provisions of this Law in terms of the prohibition of advertising the donation of reproductive cells and tissues, as well as any advertising aimed at engaging women in the provision of surrogate motherhood services.

Therefore, the lack of liability provisions will help avoid liability for some assisted reproductive technology-related offences.

CONCERNING LIABILITY FOR OFFENCES RELATED TO ASSISTED REPRODUCTIVE TECHNOLOGY: LEGISLATIVE PROPOSALS

The authors of draft laws 6517 (on amendments to the Criminal Code of Ukraine regarding offences in the field of assisted reproductive technology), 6517-1 (on administrative offences and the Criminal Code of Ukraine on liability for offences in the field of assisted reproductive technology) propose to introduce liability for offences related to the use of assisted reproductive technology. 

The authors of draft law 6517 propose to introduce criminal liability for the following actions:   

  • Transfer of a human embryo into a woman’s body without her consent (draft article 138-1 of the Criminal Code of Ukraine). This initiative is supported by the authors of Draft Law 6517-1;
  • Disclosure of information on the use of assisted reproductive technology (draft article 168-1 of the Criminal Code of Ukraine). Draft Law 6517-1 includes the same article, but with a tougher sanction.
  • Disruption of the inheritance of genetic connections when transferring an embryo into a woman’s body by using assisted reproductive technology (draft article 169-1 of the Criminal Code of Ukraine). Draft Law 6517-1 formulates the disposition of the article “Disruption of the inheritance of genetic connections when transferring an embryo” in a different way.

In fact, alternative Draft Law 6517-1 complements the provisions of Draft Law 6517. In addition, the authors of Draft Law 6517-1 propose to:

  • introduce administrative liability for a violation of the legislative requirements for the use of assisted reproductive technology or its use without a special permit, or in cases where a special permit is cancelled or suspended;
  • specify the disposition of Article 149 of the Criminal Code of Ukraine (human trafficking). Other legislative initiatives regarding amendments to Article 149 of the Criminal Code of Ukraine are available here.
CONCLUSIONS

Considering the actual provision of services of assisted reproductive technology and surrogate motherhood relations in Ukraine, the lack of a single law, there is a need to adopt a law that would regulate the use of assisted reproductive technology, surrogate motherhood in Ukraine, take into account the rights and obligations of all subjects to such relations.

Taking into account the facts stated above and despite the need to adopt such a law, the draft laws registered in the Verkhovna Rada of Ukraine as an alternative to Draft Law No. 6475 have certain deficiencies that leave a significant number of issues unresolved and cannot be supported in this version.

Introduction of criminal liability as proposed by Draft Laws 6517, 6517-1 can be considered as relevant legislative proposals, which, in conjunction with the revised draft law on the use of assisted reproductive technology, should establish appropriate guarantees for the participants in the relations arising from the use of assisted reproductive technology.

By the way, Analytical Center JurFem previously published the recommendations to be taken into account when adopting a law that would regulate the surrogate motherhood relations in Ukraine.