On the Implementation of the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation
The World Health Organization's Guidelines for the Transplantation of Human Cells, Tissues and Organs, endorsed by the LXIII Session of the World Health Assembly (WHA Resolution 63.22) (the Guidelines) regulation of transplantation of human organs and tissues. At the same time, the essence of the Guiding Principles is their national implementation, and their real "life" is ensured on national territory.
Below we will try to answer the question of how the Guiding Principles are implemented in the domestic legal system. Therefore, the subject of this study is the Guiding Principles through the prism of their national and legal implementation.
The guidelines are the culmination of the World Health Organization's allotransplant efforts over the past thirty years. Genetically, systemically and functionally, the Guidelines are linked to a number of other international sources.
The first guiding principle is that the removal of anatomical material from a person requires either his or her consent or no reason to believe that there is no such consent. Thus, the Guidelines allow states to choose one of the presumption options - consent or disagreement, taking into account their legal, cultural and religious traditions. The Ukrainian legislator is known to have implemented this provision in the spirit of liberalism: Article 14 of the Law on the Procedure for Withdrawal of Anatomical Materials from Living Donors (Lifetime Donation) requires informed consent, and Article 16 on fetal allotransplantation that if the deceased has not expressed during his / her life consent or disagreement with the posthumous donation established by the transplant coordinator, consent to the removal of anatomical materials for transplantation and / or bioimplantation from the body of such person after determining his / her condition as irreversible death according to the law is requested by the transplant coordinator personally from the other spouse or one of the close relatives of this person (children, parents, siblings). In the absence of the other spouse or close relatives referred to in this part, consent to the removal of anatomical material for transplantation shall be requested by the coordinator from the person who undertook to bury the deceased. Thus, the Law of Ukraine embodies the presumption of disagreement, while allowing a small circle of relatives to dispose of the body of the deceased.
It should be noted that the introduction of the presumption of consent in national law may at this stage be perceived by society with distrust, although it could increase the pool of available anatomical material. We believe that for reasons of democracy and legitimacy of the law, the presumption of consent can be seen, but only if the attitude of the critical mass of the population to transplantation and posthumous donation changes. At present, the Law offers, so to speak, an intermediate solution: every able-bodied person who has reached the age of full civil capacity has the right to consent to posthumous donation (Article 16, paragraph 1). Resolution of the Cabinet of Ministers of Ukraine № 1211 of December 27, 2018 was approved for the development of this provision of the Law. consent to the removal of anatomical materials from a person's body for transplantation and / or production of bioimplants after determining his condition as irreversible death, as well as submitting a written application for appointment, change or revocation of an authorized representative "(hereinafter - the Procedure). Paragraph 3 of the Procedure stipulates that an able-bodied adult has the right to submit both consent and disagreement with the posthumous donation of anatomical materials. Paragraph 7 stipulates that such applications are submitted by a natural person in writing to the transplant coordinator of any health care institution or to an employee of the specialized state institution "Ukrainian Transplant Coordination Center" or by filling out an electronic application form through the Unified State Web Portal services.
Thus, according to Part 4 of Article 13 of the Law, if the recipient has not reached 14 years of age or has been declared incapable in accordance with the law, transplantation is performed with the consent of objectively informed parents or other legal representatives. For recipients over the age of 14 or recognized in accordance with the law in accordance with the law of limited capacity, transplantation is used with the consent of such objectively informed persons. The question of the legal status of a lifelong donor was the subject of our analysis, we will only recall that, as a general rule, only a lifelong donation of an adult able-bodied person is possible. Thus, the rules governing the legal status of the donor and recipient correspond to Article 38 (1) of the Fundamentals of Health Legislation and are broadly in line with the liberal content of the commented Guidelines.
Some conclusions. Consideration of the Law of Ukraine "On the use of transplantation of anatomical materials to humans" № 2427-VIII through the prism of the Guidelines allows to demonstrate their genetic links, and thus opens the logic of the historical development of transplantation legislation in Ukraine.
A comparative analysis of the text of the Guiding Principles and the Law gives grounds to claim that a set of legal means was used for the implementation of the former by the legislator, namely various forms of transformation and reception. It should be noted that the implementation of the Guidelines has not been fully implemented due to the national legislator's rejection of the idea of emotional connection between donor and recipient as a basis that legitimizes medical intervention. The rest of the provisions of the Law provide a level of guarantees that meet, and in part exceed, that set out in the Guidelines.
Chapman J., Delmonico F., Groth C. Commentary: The World Health Assembly Resolution on Human Organ and Tissue Transplantation. Transplantation. 2010. Vol. 90. N 3. August 15. Р. 236–237.
Guide to the quality and safety of tissues and cells for human application. EDQM 4th еd. 2019. 666 p.
Resolution WHA 40.13 Development of guiding principles for human organ transplants. Fortieth World Health Assembly Geneva, 4-15 May 1987. URL: https://www.who.int/transplantation/en/WHA40.13.pdf
Resolution WHA 63.22 Human organ and tissue transplantation, adopted by World Health Assembly on 21 May 2010. URL: https://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf
World Health Assembly (1989), Resolution WHA 42.5 of 8-19 May 1989. URL: https://apps.who.int/iris/bitstream/handle/10665/171211/WHA42_1989-REC-1_eng.pdf?sequence=1&isAllowed=y
World Health Assembly (1991), Human organ transplantation: WHA 57.18. URL: https://apps.who.int/gb/ebwha/pdf_files/WHA57/A57_R18-en.pdf
World Health Assembly (1991), Human organ transplantation: WHA44.25. URL: www. transplant-observatory.org/download/resolution-wha44-25-endorsing-the-1991-guiding-principles/, accessed 7 December 2018
Pro zastosuvannya transplantatsiyi anatomichnykh materialiv lyudey : Zakon Ukrayiny vid 17 travnya 2018 r. № 2427-VIII. Vidomosti Verkhovnoyi Rady (VVR). 2018. № 28. St. 232.
Mizhnarodne pravo : navch. posibnyk / za red. M. V. Buromens′koho. Kyiv : Yurinkom Inter, 2006. 336 s.
Ostrovs′ka B.V. Zaborona finansovoyi vyhody v mizhnarodnomu pravi. Natsional′ne vykorystannya lyudyny ta yoho chastyny. Naukovyy visnyk vnutrishnikh sprav. 2018/2 (107). S. 329–347.
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