PRACA POGLĄDOWA

REVIEW ARTICLE

PROBLEMS OF TRANSPLANTATION OF HUMAN ORGANS AND OTHER ANATOMICAL MATERIALS AND DIRECTIONS OF THEIR SOLUTION IN UKRAINE

PROBLEMY TRANSPLANTACJI LUDZKICH NARZĄDÓW I INNYCH MATERIAŁÓW ANATOMICZNYCH I KIERUNKU ROZWIĄZANIA TYCH PROBLEMÓW NA UKRAINIE

Нrуhorіі S. Kraіnуk¹, Svitlana M. Pороva2, Ella V. Vakulovych2

¹ Yaroslav Mudryi National Law University, Kharkiv, Ukraine

² Kharkiv National University of Internal Affairs, Kharkiv, Ukraine

ABSTRACT

Introduction: The focus of the work is the importance of transplantation of human organs and other anatomical materials as the method of treating and a way of saving people’s lives and it also attaches particular importance to solving issues of transplantations in Ukraine.

The aim:  To find out the problems of human organ transplantation and other anatomical materials and determine the directions of their solutions in Ukraine.

Materials and methods: The assessment and analysis of domestic and foreign experience has been developed. In addition, data collected from Ukrainian and international organizations and the results of scientific research by scientists are used in the work.

Review and conclusions: Investigating the legislation of Ukraine in the part of transplantation of human organs and other anatomical materials, conclusions were made on the necessity of its improvement, in particular, Article 16 of the Law of Ukraine «On the application of transplantation of anatomical materials to a person» dated by May 17, 2018, is proposed to be worded as follows: «Any adult may give written consent or disagreement to become a donor of anatomical materials in case of his death. In the absence of such a statement of disagreement with the transplantation of his organs or other anatomical materials, consent of relatives or others is not required. In this case, the deceased person is deemed to have given consent to the transplantation of his organs or other anatomical materials».

It is proposed to make changes and significant additions to Art. 17 of the Law of Ukraine «On the application of transplantation of anatomical materials to a person» of May 17, 2018 regarding the creation of the Unified State Register of persons in need of transplantation, as well as to consolidate the procedure for its administration.

In the context of urgent transformations, the necessity to significantly increase state funding for the provision of medical services, raise the awareness and informality of citizens about transplantation, as well as to change their misconceptions about this issue are sometimes put forward.

Key words: transplantation, presumption of consent for transplantation, donor

Wiad Lek 2019, 72, 3, 457-461

INTRODUCTION

Nowadays changes seem to be underway in Ukraine leading to transformations in state-political, socio-economic and legal spheres. The construction of the rule of law and civil society requires new challenges to address the fundamental problems of legal culture [1, p. 13]. Legal culture manifests itself in the accumulated legal values that belong to the spiritual culture, has a practical orientation along with the culture of management and consists of interconnected elements [1, p. 17].

According to O.I. Bugera’s opinion, the current legal existence of Ukrainian society is marked by two opposing tendencies: the commitment to the standards of a democratic standard based on the rule of law and on the other hand, the existence of legal illiteracy, old misconceptions and still remaining legal nihilism [2, p. 193].

Transplantology has saved thousands of lives and is a common treatment for a number of pathologies, moreover, sometimes it remains the last chance for saving human lives. Taking this into consideration, transplantology can be called the phenomenon of the twentieth century. Therefore, the society has realized the importance of transplantation as a method of treatment and saving human lives and now it’s beginning to turn from undue criticism to thorough philosophical and legal analysis, searching for optimal solution of problems existing in the sphere of transplatology [3, p. 17].

In certain countries (for example: India, USA, Russia, Spain, Republic of Poland, etc.) the presumption of consent for transplantation is present into force, which means that every adult citizen of the state automatically becomes a posthumous donor if during his life he did not express disagreement with the transplantation. The positive experience of these countries is based on the researches in the sphere of psychology that claims that mostly young people do not think at all that they can die (but it happens mostly by the car accidents, on the work place or they are riddled with firearms), so they don’t thinks what will happen to their organs, and therefore do not write the wills and do not give instructions to their relatives about the use of their organs after death. As for the relatives of the dead person – they are primarily concerned with the burial issues and do not think that the bodies or tissues of their deceased relatives can save someone’s life. Data from medicine shows that often transplantation is the only chance to save lives. Certain organs can be transplanted within a few hours.

THE AIM

Searching for solutions to improve legislative regulations in the sphere of transplantation in order to save people’s lives.

MATERIALS AND METHODS

The experience of foreign countries has been used in the research. Additionally, we used data from domestic and foreign international organizations, results of scientific researches and the reports of Global Financial Integrity.

It is impossible to change situation without modifying the provisions to the national legislation pertaining to the article 16 of Law of Ukraine «On the Transplantation of Human Organs and Other Anatomical Materials» of May 17, 2018.

REVIEW AND DISCUSSION

Transplantation as a method of treating or the most severe diseases or injuries of a human being, it is used in cases where elimination of danger to life or restoration of health of the patient is impossible with other methods of treatment, of there is no alternative treatment. Transplantation – is a special method of treatment, consisting in transplanting the recipient of an organ or other anatomical material taken from a person or animal (Article 1 of the Law of Ukraine «On the Transplantation of Human Organs and Other Anatomical Materials» of May 17, 2018 [4]. In the scientific literature [5] on improving the human right to transplantation, the improvement of the editorship of art. 143 or 144 of the Criminal Code of Ukraine [6] or to consolidate the presumption of consent for transplantation, without specifying specific regulations.

A crucial area of concern is the lack of registry of people in Ukraine who is in need of transplantation, the information is not available on the official Web-site of the Ministry of Health of Ukraine [7]. Proposals to establish the registry were made in literature [8, p. 703] and they are worthy of support, as this will enable us to find out the real needs of people in transplantation and provide more effective assistance. There is no exact data on persons requiring transplant on the World Health Organization web-site [9].

In addition, it seems necessary to launch an on-line queue for people in need of transplantation in Ukraine. We suggest placing it on the official Web-site of the Ministry of Health of Ukraine. This measure will allow you to control the speed of the queue, as well as its fairness (to prevent other people from getting out of order) and it also will enable those in need of transplantation to decide whether to wait for transplantation in Ukraine or to go abroad.

It is necessary to make changes and significant additions to Art. 17 of the Law of Ukraine «On the Transplantation of Human Organs and Other Anatomical Materials» of May 17, 2018 concerning the creation of the Unified State Register of Transplants, as well as the consolidation of the order of its administration.

Consider the provisions of the Law of Ukraine of July 16, 1999 in Art. 16 contains the provision that a person must always consent to transplantation (this is a presumption of non-consent on transplantation) [10]. This law will expire in January 2019. Instead, the provisions of the new law of May 17, 2018, too, do not significantly change the situation with transplantation, since from Art. 16 [4]. Also, the provisions of the presumption of non-consent on transplantation, which does not meet the needs of Ukrainian society. In accordance with the first paragraph of Article. 16 of the Law of Ukraine «On the Transplantation of Human Organs and Other Anatomical Materials», «In the absence of such an application, anatomical materials in a deceased adult capable person may be taken with the consent of the spouses or relatives living with him until death. Anatomical materials may be taken with the consent of their legal representatives in deceased minors, disabled, or incapacitated persons». In the paragraph of the sixth, article 16 the objection is the following sentence: «In the deceased adult legal person whose application for donation is absent, as well as in minors, disabled and incapacitated persons, the taking of anatomical materials is not allowed, unless it is received or impossible to obtain the consent of the persons specified in part one of this articles» [4], since it significantly restricts the removal of anatomical materials to save the lives of others.

In other words, Ukraine still has a presumption of non-consent on transplantation, which deprives citizens of Ukraine of the right to transplant, and therefore often deprives the right to life, health and normal existence. Also, the will of the minors is limited (since even if there is an application for consent to transplantation, anatomical materials can be taken only «with the consent of their legal representatives»). This, in turn, raises another problem: the presence of permanent, so-called, transplantologic queues – records where there are people in need of transplant, in the absence of donors. And the very presumption of non-consent on transplantation does not contribute to the salvation of such people, since with the large presence of «potential donors» real, that is, those who give their bodies, there are only those who in their lives gave their consent to such transplantation, as well as those, whose relatives have given such consent, and living people who sacrifice part or body to save the life of another. Existing practice shows that people can die while awaiting for such a donor for years.

According to the Art. 3 of the Constitution of Ukraine, the Human being, his or her life and health, honor and dignity, inviolability are recognized in Ukraine as a highest social value. According to the Art. 8 of the Constitution of Ukraine, the Constitution of Ukraine has the highest legal force. Laws and other normative-legal acts are adopted on the basis of the Constitution of Ukraine and must comply with it [11]. As we see, the priority in our state is human life itself. The guarantee of the basic rights and freedoms of man and citizen and, above all, the right to life, is one of the indicators of civilization of the state. However, the provisions of Art. 16 of the Law of Ukraine «On the application of transplantation of anatomical materials to a person» is not directly, but indirectly contrary to Art. 3 of the Constitution of Ukraine, because the disagreement on transplantation existing in the law, firstly, deprives medical workers of precious time, and even when consent for transplantation is provided by the relatives of the deceased – time, unfortunately, will not allow a transplant to be carried out as it is possible during just a few hours; secondly, people do not write a will with the indication of the possibility of transplanting their organs for various reasons: some do not know that otherwise because of dissent or long reflection of their relatives it will become impossible in the long run, others do not want to sniff, others do not want to pay a notary money for the will of the will, the fourth is afraid of abuses in this area, etc. Existing wording of Art. 16 of the Law of Ukraine «On Transplantation of Organs and Other Human Anatomical Materials» promotes the removal of organs and tissues in humans by coercion or deception, trade in organs or tissues, since the demand for organs far exceeds the supply.

One of the few arguments for supporters of the presumption of non-consent on transplantation is the prevention of the image of religious feelings of relatives or relatives of the deceased. At the same time, Art. 35 of the Constitution of Ukraine contains the provision that «The Church and religious organizations in Ukraine are separated from the state, and the school is from the church. No religion can be recognized by the state as obligatory. No one can be freed from his duties to the state or refuse to execute laws on the grounds of religious beliefs» [11]. That is, opposed to preventing the image of religious feelings of relatives or close persons of the deceased and the right of another person to life. Obviously, the benefit should be the right to life of a person in need of transplantation. It does not in fact affect the ability of a person to be buried, cremated or otherwise honored, without encroachment on her religious feelings or feelings of their relatives.

The presence in the modern world of a large number of spectacular and dangerous factors, the possibility of injuries and injuries that occur at almost every step. Car accidents, acts of terrorism, consequences of hereditary or genetic diseases, ordinary domestic injuries, which can lead to lethal consequences without the need for emergency intervention, the presence of a large number of wounded servicemen as a result of military conflicts, which is now very relevant in our country, is not a complete list of that that every day endangers a person.

Still here a very strong statement remains on medical services (its level of development allows you to successfully carry out transplantation, save thousands of lives) and the right (to realize the possibilities of medicine). At the present stage, the possibilities of medicine have reached such a level that it is not difficult to replace even such a human body as the heart that stopped. In the leading countries of the world, such as, the United States, there is the so-called presumption of consent for transplantation, that is, the possibility to select, if necessary, in the deceased person organs or materials suitable for transplantation without its consent or without objection to it, which in turn allows you to save one, and sometimes a few lives. That is, if there is a death of a young person, say after a car accident, and it is possible to use her organs or tissues to save one, two, three or more people, why not do it? As you can see, the experience and good practice of transplantation in the United States seem more rational and very convincing. The death of one person makes it possible to save several others, to reduce the queues for transplantation (and in the long term – to eliminate these queues) and the corruption of this sphere, which at the moment is very important.

Therefore, in order to improve the implementation of the human right to organ transplantation in Ukraine, the first paragraph of Art. 16 of the Law of Ukraine should be worded as follows: «Every adult legal person can give written consent or disagreement to become an donor of anatomical materials in case of his death. In the absence of such a statement, in the case of deceased adults or minors, anatomical materials for transplantation may be taken regardless of the consent of the spouse or relatives living with her until death. Regardless of the existence of such a statement, in the case of deprived persons with limited capacity or incapacity, anatomical materials for transplantation may be taken regardless of the consent of their legal representatives».

Presence of a presumption of consent for transplantation in our legislation (Article 16 of the Law of Ukraine «On the Transplantation of Human Organs and Other Anatomical Materials») could have a positive impact not only on the development of medicine in our country, but also to save a large number of lives. The proposed changes to the legislation do not require additional financing from the budget, could reduce the number of crimes related to illegal transplantation, since the lack of donors is the main reason for their existence.

Currently, there are only five transplantation centers in Ukraine that carry out kidney, liver and heart transplantation operations (interestingly, over the past twenty years only 8 heart transplants have been performed in Ukraine, 1000-1500 if necessary), for comparison, Spain has 47 million population of more than 40 transplantation centers, the average number of transplants ranges from 98-115 transplants per year [12].

A.V. Musiyenko recommends the adoption of standards regulating organ transplantation in accordance with the Guidelines developed by the World Health Organization and the World Medical Association to organize bilateral and regional cooperation on the basis of the development of common standards, guided by the conventions and recommendations adopted by the Council of Europe, and also bring national laws and standards in line with these general principles [13, p. 17].

Some Ukrainian citizens are afraid of transplantation through mass media reports of «black transplantologists». However, there are positive examples in Ukraine – the STB channel clearly explained in a number of reports why the presumption of consent for transplantation is important and that without it the register of patients requiring organ transplantation is inevitably threatened with death, whereas their bodies are no longer needed for death.

If we keep the law of Ukraine «On the application of transplantation of anatomical materials to a person» of May 17, 2018 that way, then hundreds of Ukrainian citizens may die while awaiting for the vital assistance. Amendments to the law do not require additional funds from the state and local budgets. It is also free to create a registry of people in need of transplantation as well as running the on-line queue of people in need on the official Web site of the Ministry of Health of Ukraine. It will save people’s lives, furthermore, these steps are in accordance with the requirements of Art. 3 of the Constitution of Ukraine, which states that the human being is recognized as the highest social value.

Consequently, the discussion is whether to continue to spend millions of UAH on transplant operations abroad in the absence of the necessary organs and other human anatomical materials in Ukraine, or to save hundreds of lives, while still saving budgetary funds and reducing the level of illegal transplantation.

CONCLUSIONS

1. The need to review the legislation of Ukraine in the part of transplantation and the requirement of the implementation of significant improvements in order to prevent such problems as: the absence of presumption of consent, considerable underinvestment in medical services, the lack of citizen’s knowledge and their misconceptions in the transplantation area.

2. Article 16 of the Law of Ukraine «On the application of transplantation of anatomical materials to a person» of May 17, 2018, is proposed to be worded as follows: «Every adult legal person can give written consent or disagreement to become an donor of anatomical materials in case of his death. In the absence of a statement of disagreement with the transplant, consent from relatives or others is not required. In this case, the deceased person is deemed to have given consent to the transplantation of anatomical materials».

3. It is necessary to make changes and significant additions to Art. 17 of the Law of Ukraine «On the application of transplantation of anatomical materials to a person» of May 17, 2018 concerning the creation of the Unified State Register of Transplants, as well as the consolidation of the order of its administration.

4. National legislation should take into account the standards governing the organ and tissue transplantation, in accordance with the Guidelines developed by the World Health Organization, to organize bilateral and regional cooperation on the basis of the development of common standards, guided by the conventions and recommendations adopted Council of Europe, as well as bring national laws and standards in line with these general principles.

REFERENCES

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2. Bugera O.I. Pidvyshchennya rivnya pravovoyi kul’tury suspil’stva iz vykorystannyam mozhlyvostey merezhi Internet [Increasing the level of the legal culture of society using the possibilities of the Internet]. Aktual’ni problemy vitchyznyanoyi yurysprudentsiyi. 2018. No. 1, 193-196. Available at: http://apnl.dnu.in.ua/1_2018/1_2018.pdf#page=193.

3. Pashkov V. M., Golovanova I. A., Noha P. P. Principle of serviceability and gratuitousness in transplantation? Wiadomosci Lekarskie. 2016, tom LXIX, nr 3 (cz. II), 565-568.

4. Pro zastosuvannya transplantatsiyi anatomichnykh materialiv lyudyni: Zakon Ukrayiny vid 17 travnya, 2018 № 2427-VIII [On the application of transplantation of anatomical materials to a person. Law of Ukraine. May 17, 2018, No. 2427-VIII]. Available at: http://zakon3.rada.gov.ua/laws/show/2427-19.

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6. Kryminal’nyy kodeks Ukrayiny vid 05 kvitnya 2001 r. № 2341-III [The Criminal Code of Ukraine of April 5, 2001 № 2341-ІІІ]. Vidomosti Verkhovnoi Rady Ukrayiny. 2001. № 25–26. St. 131.

7. Ministerstvo okhorony zdorov”ya Ukrayiny [Ministry of Health of Ukraine]. Available at: http://moz.gov.ua/.

8. Krainyk H. S., Sachuk B. P. Problematyka rozvytku transplantatsiyi v Ukrayini [Problematics of development of transplantation in Ukraine]. Young scientist April 2018. № 4 (56), 700–703.

9. Vsesvitnya orhanizatsiya okhorony zdorov’ya [World Health Organization]. Available at: http://www.who.int/en/.

10. Pro transplantatsiyu orhaniv ta inshykh anatomichnykh materialiv lyudyni : Zakon Ukrayiny vid 16 lypnya 1999 r. № 1007-XIV [About transplantation of organs and other anatomical materials to a person: Law of Ukraine dated July 16, 1999 No. 1007-XIV]. Vidomosti Verkhovnoi Rady Ukrayiny. 1999. № 41. St. 377.

11. Konstytutsiya Ukrayiny vid 28 chervnya 1996 r. № 254k/96-VR [The Constitution of Ukraine of June 28, 1996]. Vidomosti Verkhovnoi Rady Ukrayiny. 1996. № 30. St. 141.

12. Krainyk H. S., Sachuk B. P. Problematyka rozvytku transplantatsiyi v Ukrayini [Problematics of development of transplantation in Ukraine]. Young scientist April 2018. № 4 (56), 700–703.

13. Musiyenko A. V. Zapobihannya zlochynam u sferi transplantatsiyi orhaniv ta tkanyn lyudyny [Prevention of crimes in the field of transplantation of organs and tissues of the person]: avtoref.. dys. … k.yu.n.: 12.00.08. Kyyiv : Kyyivs’kyy natsional’nyy universytet imeni Tarasa Shevchenka, 2002. 20 р.

Authors’ contributions:

According to the order of the Authorship.

Conflict of interest:

The Authors declare no conflict of interest.

CORRESPONDING AUTHOR

Hryhorіі Kraіnуk

Yaroslav Mudryi National Law University

77, Pushkinska St., 61024 Kharkiv, Ukraine

tel: +380502602452

e-mail: vip.kraynik@ukr.net

Received: 03.10.2018

Accepted: 28.02.2019