Legal basis for transplantation of human organs and tissues in the Russian Federation

One of the most progressive and rapidly developing sections of medicine is transplantology, a science that deals with transplantation problems of organs and tissues. As a method of treatment, transplantation is indicated for a wide variety of diseases. A reflection of the clinical efficacy of this method of treatment is the annual survival rate. In leading clinics this indicator is equal: for a kidney — 90–95 %; heart — 85 %; of the liver — 80 %. According to generalized data, the current world demand is at least one million clinical transplants of the kidney, heart, liver, excluding other organs. This tendency tends to progress. The founder of the transplant was the Russian scientist V. P. Demikhov. In Russia, the first heart transplant was performed by an outstanding surgeon, academician of the Russian Academy of Sciences V. I. Shumakov. Now on the account of V. I. Shumakov more than a hundred heart transplants, about two thousand — on kidney transplantation and thousands of other complicated operations.

In the Russian Federation, transplantation of human organs and (or) tissues is regulated by the Federal Law «On the Fundamentals of Health Care of Citizens of the Russian Federation» (Article 47) [3], Law of the Russian Federation of 22.12.1992 No. 4180–1 (from the item. and additional) «On the transplantation of organs and (or) human tissues» [1], and partly also by the Law of the Russian Federation from 09.06.1993 No. 5142–1 (from the edited amendment and add.) «On blood donation and its components " [2]. Transplantation of human organs or tissues is a means of saving lives and restoring health and should be carried out on the basis of compliance with the laws of the Russian Federation and human rights in accordance with the humane principles proclaimed by the world community. In Russia, as legal objects of transplantation in Art. 2 of the Law «On Transplantation» and in the order of the Ministry of Health of the Russian Federation of December 15, 2002, the following organs were named: heart, lung, heart-lung complex, liver, kidney, pancreas with duodenum, spleen, endocrine glands. This list is exhaustive. Meanwhile, the mass media can find out about transplantations and other organs performed in Russia, for example, about a tracheal transplantation. Obviously, this list, taking into account the practice, will be supplemented. Among tissues to transplants are listed: blood and its components, sperm, bone marrow. Given the differences in the medical nature and peculiarities of legal regulation that are inherent in transplantation of organs and tissues, it is necessary to separately consider transplantation using cadaver organs and tissues and transplanting with live donation. This is due to the fact that, along with similar problems, there are a number of features that are peculiar only to one of the presented types of transplantation.

According to Art. 1 of the Law «On Transplantation» and Art. 19 of the Convention on Human Rights and Biomedicine, removal of organs or tissues from a living donor for their transplantation can be done solely for the purpose of treating the recipient, provided that there is no appropriate organ or tissue obtained from the corpse, and the impossibility of equally effective treatment by alternative methods. According to the legislation in force in Russia, an adult and capable citizen can be a living donor. The involvement of underage children in bone marrow donation is permitted with the consent of the parents. When blood is withdrawn, the donor should be no older than 60 years, with the withdrawal of sperm — at the age of 20 to 40 years. The collection and harvesting of organs and tissues is allowed only to public health institutions. When concluding a donor agreement, a citizen becomes the bearer of a whole complex of relative rights and obligations (the right to information about the forthcoming procedure and its consequences, the right to refuse at any time from donation, the duty to report information on the transferred or existing diseases, etc.). A distinctive feature of transplantation with live donation is the nature of the surgical intervention, which affects the interests of two people — the donor and the recipient. In this case, the donor presents an opportunity for medical personnel to implement the introduction into their bodies, thereby violating their physical integrity. This intervention is not aimed at the actual therapeutic goals in relation to the donor, therefore here it is a question of harming human health. Taking into account that donors are people who can provide a viable body, harm is inflicted to a potentially healthy person. The level of modern medicine does not allow, unfortunately, to accurately predict the outcome of an operative intervention for the donor. Therefore, the basic conditions, the presence of which is necessary for the donation of living people, is voluntary consent combined with sufficient level of physical and mental health.

The donor should be guaranteed:

‒ preliminary comprehensive comprehensive medical examination;

‒ removing only a predetermined paired organ, part of organ or tissue, absence of significant damage to health after removal from the body of the transplant, organ or tissue transplant to a predetermined recipient (consisting of a genetic relationship with the donor);

‒ dispensary dynamic monitoring of the health after transplantation.

A recipient as a person seeking medical care should be guaranteed: preliminary comprehensive comprehensive medical examination, prevention of infection from the donor by systemic or infectious diseases (AIDS, hepatitis and d etc.) provision of specialized medical assistance in the early post-transplant period, dispensary dynamic observation of the health condition for a long time after transplantation. Article 3 of the Law «On Transplantation» is devoted to limiting the range of living donors. A special concern is the protection of the rights of minors and other «vulnerable» categories of citizens from coercion or motivation to become a donor. Donorship is not permitted: minors (except for bone marrow transplant), incapacitated persons, persons with a dangerous disease for transmission, people in official or other dependence on the recipient. Up to 90 % of transplantations are performed using cadaveric grafts. This causes the need for close attention to the legitimacy of the removal of organs and tissues from corpses. By determining the conditions and procedure for transplantation, in particular the removal of organs and (or) tissues from the corpse for transplant to the recipient in need thereof, the legislator established in art. 8 of the RF Law of 22.12.1992 No. 4180–1 «On Transplantation» prohibition of such withdrawal in the case when the health care institution at the time of seizure was informed that during the life of the person or his close relatives or legal The representative stated his disagreement with him. The legislator in this case chose the presumption of consent for the removal of organs and / or tissues of a person after his death («unsolicited consent» or «alleged consent»), which treats the person, his close relatives or legal representatives, fixing this or that will as the presence of a positive will for the implementation of such an exemption. The main areas that need to be considered for transplantation using cadaver organs and t kana, include the ratio of the right to life of the donor and: the rights of medical personnel to disable the means of sustaining the life of a dying person, which is considered as a potential donor, the duration of resuscitation with a medically obvious lethal outcome, the problems of active and passive euthanasia; diagnosis of the «brain death» of a potential donor, the terms «potential donor» and «donor» themselves. Given the present situation in tissue transplantation, when only 15 % of donors are living people, the importance of using cadaveric grafts for these purposes is beyond doubt. But in these conditions it is necessary to clearly define the role of the will of the deceased, made during life, regarding the possibility of removing organs or tissues. [4]

At the same time, the procedure for processing such an act needs to be worked out: determining the conditions for the legality of the form of compilation, the availability of witnesses, the importance of documentary assurance. An analysis of the Russian criminal legislation indicates the possibility of criminalization of relations in the field of transplantology. In particular, the Criminal Code of the Russian Federation has article 120 («Compulsion to seize human organs or tissues for transplantation»). Progress in the area of ​​transplantation of organs and tissues gave rise to the possibility of the emergence of criminal situations associated with the search for suitable persons for the removal of organs and tissues from them, including by coercion, which explains the establishment of the said norm in the Criminal Code. However, in the legal literature, that the title and content of Article 120 of the Criminal Code of the Russian Federation should concern not only transplantation. Forcing people to remove organs or tissues can pursue other goals, for example, carrying out experiments or using embryonic tissues (materials) for the manufacture of medicinal products (so-called stem cells), etc. Therefore, the criminal-legal protection of human rights and freedoms would become more effective if appropriate changes and additions were included in this provision.

Transplantation of organs and tissues set a whole range of moral, ethical, medical and legal problems for society. The fundamental difference between transplantation and all other medical operations is the presence of a donor — a person who does not need medical help, but whose health is being harmed as a result of transplantation. The progressive development of transplantation presupposes adequate provision of its legal mechanism. Absence or inadequate legal regulation will artificially restrain the growth and implementation of organ and tissue transplantation, potentiates to ensure the criminalization of this sphere of medicine. Clear and fully formulated legal norms can have a direct impact on the activities of medical workers, facilitating the exit from difficult situations and preventing the possibility of offenses.

1. Federal Law No. 4180-I of December 22, 1992 («On Transplantation of Organs and / or Human Tissues» (with amendments and additions).
2. The Federal Law «On Blood Donor and Its Components» of 20.07.2012 N 125-FZ3.
3. Federal Law «On the Fundamentals of Health Care of Citizens of the Russian Federation» of November 21, 2011 N 323-FZ 4.
4. Vorobyova LV Medical Law.- Tambov: GOU VPO TSTU, 2010.