Legal Regulation of Donating Embryos for Scientific Research and for the Infertility Treatment in Ukraine
Main Article Content
Abstract
The aim. The purpose of this study is based on a study of Ukrainian experience in the field of legal regulation of the use and donating of embryos in vitro for research purposes and infertility treatment, analyzing cases of European Court on human rights in this field, to suggest ways to fill the gaps in current legislation of Ukraine and bring it into line with international law.
The subject of the research was the legal regulation of donating embryos for scientific research and for the infertility treatment in Ukraine, which is an interesting experience for scientists from other countries, since Ukraine has become a candidate for European Union (EU) membership, and thus the peculiarities of the legal regulation of embryo donation in Ukraine will allow us to identify the positive and negative aspects of embryo donation and the possibility of conducting a comparative analysis with foreign regulation. In Ukraine, donation of gametes and embryos is a procedure according to which donors, with written voluntary consent, provide their reproductive cells-gametes (sperm, oocytes) or embryos for use in other persons within the treatment of infertility. The application of embryo donation is carried out according to medical indications, subject to the presence of written informed voluntary consent of the patients, ensuring the anonymity of the donor and maintaining medical secrecy. The study is based on an interdisciplinary approach to the analysis of the problem of legal protection of the embryo using dialectical, comparative legal, and systemic methods. The research used scientific developments in the field of problems of the legal status of the human embryo, international acts, the legislation of Ukraine, the practice of the European Court of Human Rights (ECHR).
Conclusion. The issue of legal protection of intellectual property rights, the object of which is the human genome, tissues or cells, is currently being hotly debated in the world. However, legal approaches to the possibility of patenting such objects can be divided into those that completely deny the patenting of the human genome, as well as other human tissues and cells, and those that cause such a process of certain restrictions of moral, ethical and legal nature, such as for example, the issue of ensuring the confidentiality of information about the person whose materials are being investigated. It seems that in view of the above practice of the ECHR, it would be appropriate to establish the possibility of free use of the results of such research, which would be in the interests of society and science.
Donors of embryos in Ukraine can be patients of the in vitro fertilization program, who have unused cryopreserved embryos left in the cryobank after the birth of a child. In case of fertilization of donor oocytes with donor sperm, their transfer into the recipient's uterine cavity or cryopreservation (with subsequent transfer in subsequent cycles) are possible. With the voluntary, informed, written consent of donor patients, these embryos may be used for donation to an infertile patient/recipient couple, as well as unmarried female recipients.
Assignment of embryos and embryo-fetal materials to the category of biological material does not mean that they are subject to the rules of property law, but they should be considered as special objects that are under state protection and are in close legal personal connection with the above mentioned persons, who are given the right to determine their future fate within the limits established by law. The right to dispose of embryos for research purposes may be granted by the woman and the man for whom the embryo was created, subject to informed consent and consent to the processing of personal data.
Article Details
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
2. Kovalova O Deontolohiia v medytsyni: pidruchnyk. Kyiv: VSV «Medytsyna»; 2015. p.111. (In Ukrainian).
3. Pro zatverdzhennya Poryadku zastosuvannya dopomizhnykh reproduktyvnykh tekhnolohiy v Ukrayini. Nakaz MOZ vid 09.09.2013 № 787. Available at: https://zakon.rada.gov.ua/laws/show/z1697-13#Text (In Ukrainian).
4. Valid Kamalʹ Abdelʹ Salam Atia. Pravove rehulyuvannya pravovoho statusu embrionu. Seriya: Derzhavne upravlinnya 2019 р., № 3 (67).С.43-47 С. 46 (In Ukrainian)
5. Korenha Y.U. Vyznachennya pravovoho statusu embriona. Istoryko-pravovyy chasopys. 2016. №2 (8). S.99-102 s.101 (In Ukrainian).
6. Zabolotna M. Embrion – subʺyekt chy obʺyekt reproduktyvnykh pravovidnosyn? Yurydychnyy visnyk 2021. №1 С.225-234 С.231 (In Ukrainian).
7. Pro zatverdzhennya Instruktsiyi zvyznachennya kryteriyiv perynatalʹnoho periodu, zhyvonarodzhenosti ta mertvonarodzhenosti, Poryadku reyestratsiyi zhyvonarodzhenykh ta mertvonarodzhenykh: nakaz Ministerstva okhorony zdorovʺya Ukrayiny vid 29 bereznya 2006 r. № 179. Available at: https://zakon.rada.gov.ua/laws/show/z0427-06 (In Ukrainian).
8. Simeynyy kodeks Ukrayiny: Zakon Ukrayiny vid 10.01.2002 № 2947-III Available at: http://zakon4.rada.gov.ua/laws/show/2947-14 (In Ukrainian).
9. Lyubych L.D. Pravovyy status nenarodzhenoyi dytyny u pravovidnosynakh shchodo realizatsiyi reproduktyvnykh prav lyudyny. Administratyvne pravo i protses. 2015. № 2(12). С. 262-273 263 (In Ukrainian).
10. Case of Vo v. France 2004. Available at: http://hudoc.echr.coe.int/sites/eng/pages/search.aspx?i=001-61887
11. Case of A, B and C v. Ireland. 2010 Available at: http://hudoc.echr.coe.int/eng?i=001-102332
12. Soni S Limits for human embryo research have been changed: this calls for public debate. The Conversation. 2021; June 30. Available at: https://theconversation.com/limits-for-human-embryo-research-have-been-changed-this-calls-for-public-debate-162305.
13. Matthews K RW, Moralí D National human embryo and embryoid research policies: a survey of 22 top research-intensive countries. Regenerative Medicine. 2020; 15:7: 905-1917. Available at: https://www.futuremedicine.com/doi/10.2217/rme-2019-0138.
14. Hyun I, Wilkerson A, Johnston J Embryology policy: revisit the 14-days rule. Nature. 2016; 533: 169–171. Available at: https://www.nature.com/ polopoly_fs/1.19838!/menu/main/topColumns/topLeftColu-mn/pdf/533169a.pdf.
15. Report on Human Embryonic Stem Cell Research. Available at: https://ec.europa.eu/commission/presscorner/detail/en/MEMO_03_81
16. The decision of the European Court of Human Rights of 18.10.2011 № С-34/10. Available at: https://dejure.org/dienste/ver-netzung/rechtsprechung?Text=C-34/10
17. Ehrenstein C. Kein Patent auf Embryo-Stammzellen. Die Welt. 2011. Available at: https://www.welt.de/print/die_welt/politik/article13668377/Kein-Patent-auf-Embryo-Stammzellen.html (In German).
18. Kvit N.M. (2020) Biobanky v Ukraini: tsyvilno-pravovyi aspekt: monohrafiia. [Biobanks in Ukraine: civil law aspect: monograph.] Lviv: Kvart; 2020. (In Ukrainian).
19. Case Of Parrillo V. Italy (Application no. 46470/11). Available at: https://www.globalhealthrights.org/wp-content/uploads/2016/05/PARRILLO-v.-ITALY-.pdf
20. Krushelʹnytsʹka H.L. Kriokonservovani embriony in vitro yak obʺyekty tsyvilʹnykh prav. Chasopys tsyvilistyky. Vypusk 37. 2020. S.36-41 S.40 (In Ukrainian).
21. Fisahn А., Genetischer Code – Rechtlicher Schutzperspektiven, RDV 2002, S. 15-21. Available at: http://www.jura.unibielefeld.de/lehrstuehle/fisahn/veroeffen-tlichungen/2001/Genetischer_Code___rechtliche_Schutzperspektiven.pdf
22. Das Bundesverfassungsgericht Entscheidung 1,37. Available at: http://www.servat.uni-be.ch/dfr/bv039001.html.
23. Kvit N.M. Problema vyznachennya pochatku lyudsʹkoho zhyttya y rehulyuvannya mezh vykorystannya embriona yak obʺyekta zberihannya v biobanku. Naukovyy visnyk Mizhnarodnoho humanitarnoho universytetu. Ser: Yurysprudentsiya. 2019. № 40. S. 83-91. (In Ukrainian).
24. Sándor J. A humán reprodukciós orvosi eljárások jogi szabályozásáról. [On the legal regulation of medical procedures for human reproduction.] Acta Humana. 1996; 25:36. (In Hungarian).
25. Zeller J A testen kívül létrejött embriók morális és jogi státusa a reprodukcióhoz való jog és a tudományos kutatás tükrében. [The moral and legal status of out-of-body embryos in the light of the right to reproduction and scientific research]. PHD értekezés tézisei. Pécs; 2009. (In Hungarian).
26. Beckmann J.P. Der Schutz von Embryonen in der Forschung im Bezug auf Art.18 Abs.1,2 des Menschenrechtsübereinkommen zur Biomedizin. Das Menschenrechtsübereinkommen zur Biomedizin des Europarates: taugliches Vorbild für eine weltweit geltende Regelung? Hrsg. Johen Taupitz; Institut für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim: Springer Verlag, 2002. 833s.
27. Stefanchuk R.O. Vyznachennya momentu vynyknennya prava na zhyttya: prodovzhuyuchy dyskusiyu. Yurydychna Ukrayina. 2005. № 10. S. 38-43. C.39-40 (In Ukrainian).
28. Kvit N.M. Problema vyznachennia pochatku liudskoho zhyttia y rehuliuvannia mezh vykorystannia embriona yak obiekta zberihannia v biobanku [The problem of determining the beginning of human life and regulating the boundaries of the use of the embryo as an object of storage in a biobank]. Scientific Bulletin of the International Humanities University. Ser: Jurisprudence. 2019; 40:83-91. (In Ukrainian).
29. Mannix L. Scientists create model embryos in lab, raising major ethical questions. The Age. 2021; March 18. Available at: https://www.theage.com.au/national/scientists-create-model-embryos-in-lab-raising-major-ethical-questions-20210317-p57bkc.html.
30. Carrol J Embryo research law needs tweaking to catch up with science. The Age. 2021; June 7. Available at: https://www.monash.edu/discovery-institute/news-and-events/news/2021-articles/embryo-research-law-needs-tweaking-to-catch-up-with-science.
31. Dorofeyeva L.M., Karabin T.A., Mendzhul M.V., Khokhlova I.V. Embrion i plod cheloveka: problemy pravovoy zashchity. Georgian Medical News. No 9 (306) 2020 C. 164 C.162-166 (In Ukrainian).
32. Laundry D.W., Zucker H.A. Embryonic death and the creation of human embryonic stem cells. Jouurnal of Clinical Investigation. 2004. Vol. 114(9). Р.1184-1186
33. Krushelʹnytsʹka Hanna. Tsyvilʹno-pravovi aspekty donatsiyi embrioniv lyudyny in vitro. Pidpryyemnytstvo, hospodarstvo i pravo. 2021. №3. С.43-49 С.48 (In Ukrainian).
34. Kvit N.M. Pravovyy rezhym neimplantovanoho embriona in vitro z pozytsiy doktryny, tsyvilʹnoho zakonodavstva ta sudovoyi praktyky. Chasopys Kyyivsʹkoho universytetu prava. 2020. №2 С. 241 С.238-242(In Ukrainian).