Cryopreservation of embryos: on the question of the concept

Purge Anna Rolandovna PhD in Law Associate Professor at the Department of Private Law of Vladivostok State University 690014, Russia, Primorsky Krai, Vladivostok, Gogol str., 41, office 5502 a.purge@mail.ru Other publications by this author

Today, at the conceptual level, the existence of a demographic problem is emphasized in the Russian state: Thus, in recent years there has been an annual decline in the population, and, according to the most unfavorable forecasts reflected in the content of the adopted Concept of Demographic Policy of the Russian Federation, by the beginning of 2025 the number of people living here will be approximately 16 million less than it was at the beginning of 2005 ^[1]. On the one hand, the existence of this problem is associated with the conscious unwillingness of the younger generation of Russian citizens to have children, to continue their own kind: thus, according to the results of sociological research, almost every tenth person in Russia is a childfree ^[2]. On the other hand, at the moment, the problem of infertility of citizens who have reached puberty, reproductive age and do not have other significant health problems is very acute: according to the reported statistical indicators, in 10-20% of cases, one of the spouses has limited physiological abilities to conceive, bear a child, and procreate ^{[3, p. 83]}, at the same time, the indicators of male infertility have doubled over the past 18 years ^[4].

Obviously, realizing that the already not so prosperous demographic situation in Russia can only worsen over the years, without the proper level of state support in its solution, the domestic legislator, since 1990, has embarked on the path of regulating the practice of using various methods of assisted reproductive technologies to ensure satisfaction of one of the basic, natural needs most people in the continuation of their own kind. Such a legislative approach fully complies with the constitutionally enshrined provisions on the protection and protection of the institutions of family, childhood, motherhood and fatherhood on the territory of the Russian state ^[5].

One of the methods of assisted reproduction, which has become increasingly popular in recent years, both on the territory of the Russian state, in particular, and on the territory of a number of other foreign countries (in particular, for example, the Republic of Tajikistan, where the demographic problem is not as acute as in Russia), is cryopreservation of embryos, in its most general form, it is a method of long-term storage of human genetic material (embryos) due to their freezing, thanks to which, at the right moment, these genetic materials can be used for the purpose of embryo planting, its further gestation and procreation. The implementation of this method in practice allows a person to become a parent of their child genetically and beyond the loss of their own reproductive function, for example, due to cancer and its consequences, due to reaching senile age, as well as for a number of other reasons, which makes its use, of course, valuable and significant.

However, with great regret, we are forced to state the fact that neither the current legislation of Russia nor the current legislation of the Republic of Tajikistan enshrines a legal definition of the concept of "cryopreservation of embryos": in the Republic of Tajikistan, the only regulatory legal act that enshrines the right to use this method of assisted reproductive technologies is  The Health Code of the Republic of Tajikistan dated May 30, 2017 No. 1413 ^[6], and in Russia - the Order of the Ministry of Health of the Russian Federation dated 07/31/2020 No. 803n "On the procedure for the use of assisted reproductive technologies, contraindications and restrictions to their use" ^[7].

These circumstances together inevitably generated scientific interest in embryo cryopreservation, the order of its regulation by domestic scientists (including such as V.Y. Albitsky ^[8], O.V. Gorbunova ^[9], N.E. Rusanova ^[10], E.A. Demkina ^[11], G.I. Eliseeva ^[12], I.A. Maksimova ^[13], as well as a number of others who studied it in the context of its application in the framework of the practical implementation of the surrogacy program, however, also did not offer its legal definition.

However, we consider it extremely important to formulate a legal definition of the concept of "cryopreservation of embryos", due to the fact that the level of popularity of using this method of assisted reproduction in recent years has only been growing in the world (for example, in 2020, 356 embryos were cryopreserved in the Sverdlovsk region alone as part of the implementation of free IVF programs, and as part of the provision of paid medical services for cryopreservation - 128 ^[14]).

The lack of a legal definition of the concept of "cryopreservation of embryos" forces us to turn to the provisions of the domestic legal doctrine in the hope of getting at least some explanations of what it is. However, all existing definitions are of a purely narrow-profile, medical nature, and from this point of view, embryo cryopreservation is "a method of storing the genetic embryonic biomaterial of the human body in a frozen state (in liquid nitrogen at a temperature of minus 196 ° C) for a sufficiently long time period until demand, after which they are thawed with complete preservation of the entire set of inherent functions" ^{[15, p. 196-197]}.

Exactly the same vision of the essence of embryo cryopreservation is also held by medical organizations that are carrying out the practical implementation of this method of assisted reproduction on the territory of the Russian state at the moment, which has become quite obvious, in particular when referring to the content of the official websites of a number of medical reproductive clinics that are freely available on the Internet information and telecommunications network (in including the reproductive clinic "Genome" ^[16], the Clinical Hospital on Yauza ^[17], the Center for Reproductive Health "SM-Clinic" ^[18], as well as a number of others).

Meanwhile, in such a formulation, the consolidation of the legal definition of the concept of "cryopreservation of embryos" is hardly appropriate, since it covers only one special feature of cryopreservation, its medical component, and does not take into account all the other so-called common features inherent in all other methods of assisted reproduction, among which, as we remember that the following stand out: modern, innovative biomedical technologies, focus on maintaining the reproductive health of persons applying for their use, auxiliary nature, mandatory receipt of informed voluntary consent of the patient for appropriate medical intervention in the form of the use of these technologies; special psychological and ethical nature of the application.

Without repeating the characteristics of the general signs of embryo cryopreservation as one of the methods of assisted reproduction, which we have already written about in one of our scientific studies, we will focus in more detail and meaningfully on the analysis of special signs inherent in it. Among those, in particular, the following stand out below.

1 A special medical procedure for its practical implementation.

"An embryo is a female egg fertilized by male sperm, ready for further development within the female body during its gestation: their cryopreservation becomes necessary for the successful implementation of the IVF program, in which only two embryos are planted in the female uterus cavity, and the remaining ones are stored in frozen form for the possibility of their further use in cases when the transplant the embryos in the first IVF protocol did not lead to the desired results. Among other things, cryopreservation of embryos is also used during the implementation of the surrogacy program, in order to ensure the possibility of their repeated implantation into the body of a woman acting as a surrogate mother" ^[19].

"The procedure of embryo cryopreservation itself is as follows: embryos obtained in the process of artificial fusion of male and female germ cells are carefully selected by an embryologist: only genetically healthy, viable human embryos are subject to selection. Then the selected embryonic cells are mixed with special solutions - cryoprotectors, and subjected to rapid freezing. The container with frozen embryos is placed in a container containing liquid nitrogen, which has an extremely low extreme temperature of 196 ° C, under the influence of which all vital processes in the cells of the embryo are suspended (although again, we emphasize, their viability is fully preserved (when defrosting, their survival rate is over 90%), more moreover, for an extremely long period of time (at least 10 years, and more is allowed). Each container with frozen embryos has its own unique marking, which allows identifying the genetic parents of the embryo, which makes it possible to exclude errors or substitution of embryos" ^[20].

2 The possibility of practical implementation both on a reimbursable and gratuitous basis.

The contents of the above-mentioned Order of the Ministry of Health of the Russian Federation indicate that cryopreservation is an integral stage of the IVF program, which in some cases, if there are medical indications (clinically diagnosed infertility, not amenable to drug treatment for twelve years) is funded by the funds of the mandatory medical insurance fund), and in this case the practical implementation of the procedure cryopreservation will be gratuitous. In all other cases, the process of embryo cryopreservation itself (for example, in order to preserve genetic embryonic material in case of severe oncological diseases that actually lead to sterilization of men and women, or in case they reach reproductive age), carried out at the request of individuals, is carried out on a reimbursable basis.

At the same time, our analysis of price lists published on the official websites of medical reproductive clinics operating on the territory of the Russian state demonstrated the rather expensive cost of this procedure. Let's make a reservation right away that we have analyzed the pricing policy for the provision of medical services for cryopreservation of biological material from 15 different medical clinics located on the territory of various subjects of the Russian state, and according to the results of the analysis, it becomes quite obvious that the services of a medical organization for cryopreservation procedures, taking into account the subsequent annual storage of frozen biological material, its thawing will cost on average, in the range from 30400 to 122000 rubles, depending on the region.

This, in our opinion, negatively affects the availability of this method of assisted reproduction for the majority of citizens, whose average salary in accordance with official statistical indicators as of 2021 amounted to 56,545 rubles ^[21], and represent one of the problems of its practical implementation. It seems to us expedient, in order to solve and overcome it, as one of the legal guarantees of ensuring the reproductive rights of Russian citizens, to establish in the provisions of the current legislation a norm according to which it will be possible to receive a quota from the state to pay for the procedure of cryopreservation of embryos (at the expense of funds from the federal, regional budget)  not only within the framework of the practical implementation of the free ECO-program, but also if there are other good reasons for that. Such grounds, in particular, in the law can be called the presence of a person with an oncological diagnosis, the treatment of which through the use of chemotherapy can lead to complete, irrevocable sterilization of a person, as well as the presence of a genetic diagnosis that can be transmitted from him, as from a parent to his child of a specific sex in the natural process of conception (in this case it is possible to see cryopreservation of embryos of a certain sex, which excludes the transmission of this genetic disease by inheritance, in order to subsequently plant it in a woman's body for further gestation in the most favorable circumstances of her life). Such legislative changes will increase the availability of the embryo cryopreservation procedure for Russian citizens who have fallen into a difficult life situation and do not have the financial ability to pay for it independently, and will also allow these citizens to procreate in the most favorable living conditions for them, any, even a long time later.

Taking into account the above, we will formulate our own author's definition of the concept of "embryo cryopreservation": this is a modern, innovative biomedical method of assisting in promising childbearing to persons who, due to various objective reasons, risk further losing their own reproductive function due to various reasons (for example, sterilization as a result of chemotherapy as a method of treating oncological diseases, due to the achievement of age beyond the limits of childbearing; due to the risk of developing hereditary genetic diseases in an embryo of a certain sex, other)  and they will not be able to independently realize their right to have a child and build a family in a natural way, when using which embryonic cells are mixed with special cryoprotective solutions, with their subsequent rapid freezing and placement in a container containing liquid nitrogen having an extremely low extreme temperature - 196 ° C, under the influence of which all processes vital functions in the cells of the embryo are suspended, which is realized upon prior receipt of the voluntary, informed consent of these persons who are in an unstable psychological state., both on a reimbursable and gratuitous basis. In such a formulation, the definition of the concept of "cryopreservation of embryos" is recommended by us for legal consolidation in the provisions of paragraph 30 of the Order of the Ministry of Health of the Russian Federation No. 803n dated 31.07.2020, as well as in the provisions of the Health Code of the Republic of Tajikistan.

Thus, summarizing the above, we come to the following conclusions:

Currently, there is no legally fixed definition of the category "cryopreservation of embryos" at the legislative level in Russia, and the doctrinal vision of its essence is narrow-profile, purely medical, and does not cover all the many inherent features of it as a method of assisted reproduction, among which, in particular, in addition to common to all of them, there are also special, in particular including: a special medical procedure for its practical implementation, as well as the possibility of implementation both on a reimbursable and gratuitous basis.

Taking this into account, we formulated our own author's definition of the concept of "cryopreservation of embryos", recommended for consolidation at the legislative level in Russia and the Republic of Tajikistan, and also made a proposal to increase the availability of this method of assisted reproduction.