Problems of Legal Regulation of Organ Transplantation in Ukraine and EU

  • V. H. Galchynskyi assistant of the Department of Medical Law, Faculty of Postgraduate Education Danylo Halytsky Lviv National Medical University https://orcid.org/0000-0002-0024-7148
  • S. V. Galchynskyi Bachelor of International Law, Specialist in International Advocacy, 2nd year master’s student, Faculty of International Relations of Lviv National University named after Ivan Franko https://orcid.org/0000-0002-1593-3378
Keywords: transplantation, transplant-coordinator, the moment of irreversible death, El Modelo español

Abstract

The thoroughness of the legal basis has a direct influence on the efficiency of the work and the development of transplantation, while the development of transplantation itself reflects the development of the state. The goal of the article is to analyse current legislation of Ukraine and the European Union on transplantation of anatomical materials.

The article contains the analysis of the novels of the concept and the peculiarities of the unique system of donor-recipient coordination, as well as the issues of financing transplant operations and permitting healthcare institutions and scientific institutions of all forms of ownership to perform transplantation activities in Ukraine. In particular, the rights and responsibilities of the transplantation coordinator, strengthening of sanctions in the Criminal Code of Ukraine to prevent illegal transplantation of anatomical materials to humans, requirements to the «extraction base» and the «transplant centre», the rights and social protection of the living donor and his family members are investigated in detail.

The article contains the detailed research of the Law of Ukraine «On the Application of Transplantation of Anatomical Materials to a Person», which was adopted on 17 May 2018 and came into force on 1 January 2019 and is now the main legal basis for transplantation activities in Ukraine. In particular, the rights and social protection of living donors and their family members, amendments to the Fundamentals of the Legislation of Ukraine on Health Care regarding to clear definition of the term “irreversible death” which should be understood as the moment of human brain’s death, or biological death, the rules of the confirmation of brain death by a panel of doctors in the health care facility where the patient is staying, had been explored.

The article considers in detail the duties and qualification requirements of transplantation coordinator who is one of the key persons in the transplantation system in Ukraine according to the Law of Ukraine «On the Application of Transplantation of Anatomical Materials to a Person». Transplantation coordinators are required to have at least a master’s degree in health care and to be a medical officer of a healthcare institution that has been authorised to carry out transplantation activities. An important safeguard measure reflected in the law is that the transplantation coordinator can’t be a member of the consilium of doctors which confirms the death of the donor and can’t participate in the extraction of anatomical material or perform the transplantation.

The article also compares Ukrainian legislative base on organ transplantation with the legislation of the European Union, especially the Spanish experience which gained worldwide recognition and has been named the Spanish Model». The Spanish Model, or MODELO ESPAÑOL, has been recommended by the World Health Organisation as a model for the improvement of transplantology in other countries. The use of legal models of donor material removal approved by the World Health Organisation – presumption of consent and presumption of non-consent in EU and in Ukraine had been explored. In particular, Ukraine accepted a presumption of non-consent, that is, if a person did not express his or her oral or written consent during his or her lifetime, then family members can decide whether to donate organs.

The authors investigated that the difference in the application of the presumption of consent and the presumption of non-consent for post-mortem donation is almost the main problem of the legal basis for transplantation in the European Union. Nineteen EU countries have a presumption of consent, seven countries have a presumption of non-consent, and one country uses a mixed system. This leads to the fact that, in practice, the families of the deceased donor play a decisive role in every transplantation operation. The introduction of a unified approach to post-mortem donation in the EU has been the subject of debate to date.

The authors also researched the directives and regulations of the European Union which establish the standards of quality and safety of organs at all stages of transplantation (organ collection, transportation, and directly transplantation) and common requirements for information procedures for cross-border exchange between EU Member States of human organs intended for transplantation.   European Union rules on organ donation and transplantation are set out in Directive 2010/45/EU (the «European Organ Directive») which sets standards for the quality and safety of organs intended for transplantation covering all stages of the process from donation, procurement, and transportation for transplantation. The Commission Directive 2012/25/EU on information procedures for the cross-border exchange between Member States of human organs intended for transplantation helps to implement the European Organ Directive. National competent authorities are responsible for implementing the requirements set by EU legislation.

The main responsibility for policy formation in the field of health care, organisation and provision of medical care lies primarily with the EU member states. However, the EU is addressing organ donation and transplantation through legislation, an action plan, and jointly funded projects. The EU can take measures establishing high quality and safety standards for substances of human origin such as blood, organs, tissues, and cells, according to the Article 168 of the Treaty on the Functioning of the European Union.

The EU Directives also set uniform requirements for EU countries: regarding the voluntariness and freeness of all organ donations with proper recording of consent, regarding the level of qualification of medical personnel, availability of a permit for transplantation activities, and protection of information and personal data during the exchange of information about donors. Competent authorities of EU member states are responsible for fulfilling the requirements established by EU legislation.

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Published
2022-10-13
How to Cite
Galchynskyi, V. H., & Galchynskyi , S. V. (2022). Problems of Legal Regulation of Organ Transplantation in Ukraine and EU. Medicne Pravo, (2(30), 24-48. https://doi.org/10.25040/medicallaw2022.02.024
Section
Articles