GENETIC INFORMATION: LEGAL NATURE AND CONCEPTUAL AND CATEGORICAL APPARATUS

Svitlana Iasechko, Elena Kokhanovskaya, Iryna Senyuta

Abstract


Objective: The article aims to analyze the legal nature of genetic information, its definition, and regulatory framework, especially in the context of Ukrainian and European Union legislation, while proposing the harmonization of national law with international standards.

Method: The study adopts a qualitative approach using systemic-structural, historical-legal, comparative, and analytical methods. Legislative acts from Ukraine, the European Union, and international treaties were reviewed, along with relevant doctrinal literature and legal documents.

Results: The analysis revealed that, despite the crucial role of genetic information in medicine, Ukrainian legislation lacks a clear and consistent definition. Conceptual discrepancies were identified between terms such as “genetic data,” “genetic information,” and “medical information.” The comparative study highlighted the need for coherent legal terminology and regulatory measures to ensure ethical, confidential, and proportionate handling of genetic information.

Conclusion: Genetic information should be explicitly classified as sensitive personal data and regulated under a clear conceptual framework. The article proposes revising and standardizing legal definitions in Ukrainian law to align with the GDPR and international bioethics treaties.


Schlagworte


Data; Information; Genetic Information; Genomic Information; Legal Regulation; Confidentiality; Genetic Data; International Standards; Ukraine; European Union

Literaturhinweise


ARISTOVA, I. V. (2000). State information policy: Organisational and legal aspects. In O. M. Bandurka (Ed.), Kharkiv, p. 9.

ANNAS, G. J., GLANTZ, L. H., & ROCHE, P. A. (1995). Drafting the Genetic Privacy Act: Science, policy, and practical considerations. Journal of Law, Medicine & Ethics, 23(4), 362.

BELGIUM. (1987). Koninklijk besluit van 14 december 1987 houdende vaststelling van de normen waaraan de centra voor menselijke erfelijkheid moeten voldoen. Belgisch Staatsblad, 25 december 1987.

BELGIUM. (2003). Law of 28 January 2003 on medical examinations performed within the framework of employment relations. Belgisch Staatsblad, 9 April 2003.

BELGIAN GOVERNMENT. (2014). Wet van 4 april 2014 betreffende de verzekeringen [Law of April 4, 2014 on Insurance].Belgian Official Gazette. Retrieved from https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=nl&la=N&cn=2014040423&table_name=wet

Bezrukov, V. F. (2006). Genome. In I. M. Dziuba, A. I. Zhukovskyi, M. H. Zhelezniak [et al.] (Eds.), Encyclopedia of Modern Ukraine [Electronic resource]. Institute of Encyclopedic Research of the NAS of Ukraine. Retrieved from https://esu.com.ua/article-29086

CLAYTON, E. W., EVANS, B. J., HAZEL, J. W., & ROTHSTEIN, M. A. (2019). The law of genetic privacy: Applications, implications, and limitations. Journal of Law and the Biosciences, 6(1), 1–36. https://doi.org/10.1093/jlb/lsz007 (accessed 21.07.2024).

CALLENS, S. (1995). Goed geregeld? Het gebruik van medische gegevens voor onderzoek. Antwerpen: Maklu.

CORNELIS, C. (2021). Genetische Gegevens En Verzekeringen. Antwerpen: Universiteit Antwerpen.

COUNCIL OF EUROPE. (1997). Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine. Retrieved from https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164

DE PAOR, A. (2017). Genetics, disability and the law: Towards an EU legal framework. Cambridge: Cambridge University Press.

DE HERT, P., & DE SCHEPPER, T. (2016). The new European data protection regulation of 27 April 2016. CBR Yearbook 2015/2016, 23.

DEFLOOR, S., & NYS, H. (2011). Patiëntengegevens en verzekeringen: Een onmogelijke relatie? In Over grenzen. Liber Amicorum Herman Cousy (pp. 496). Antwerpen: Intersentia.

EXPLANATORY DICTIONARY OF THE UKRAINIAN LANGUAGE. (2024). Retrieved from https://slovnyk.ua/index.php?swrd=%D0%B2%D1%96%D0%B4%D0%BE%D0%BC%D0%BE%D1%81%D1%82%D1%96

HAQUE, F. N., GOTTESMAN, I. I., & WONG, A. H. C. (2009). Not really identical: Epigenetic differences in monozygotic twins and implications for twin studies in psychiatry. American Journal of Medical Genetics Part C: Seminars in Medical Genetics, 151C, 136.

HOGE GEZONDHEIDSRAAD. (2012). Advies nr. 8714 - Genetische zelftests, april 2012.

KALYUZHNYI, R. A., KRUPCHAN, O. D., PAVLOVSKYI, V. D., HUTSALIUK, M. V., TSYMBALIUK, V. S., & SHVETS, M. Y. (2002). Informatisation, law, management: Organisational and legal issues (M. Y. Shvets & O. D. Krupchan, Eds.). Kyiv.

KOHANOVSKA, O. V. (2006). Theoretical problems of information relations in civil law: Monograph. Kyiv: Kyiv University Publishing and Printing Centre.

KUNAKH, V. A. (2006). Genetic information. In I. M. Dziuba, A. I. Zhukovskyi, M. H. Zhelezniak [et al.] (Eds.), Encyclopedia of Modern Ukraine [Electronic resource]. Institute of Encyclopedic Research of the NAS of Ukraine. Retrieved from https://esu.com.ua/article-29067

TACK, S., & DIERICKX, A. (2008). Nader gebruik van lichaamsmateriaal voor wetenschappelijk onderzoek: Toelaatbaarheid getoetst vanuit het recht op respect voor het privéleven (art. 8 EVRM). T.Gez., 2008-09, 391.

VERKHOVNA RADA OF UKRAINE. (2022). On state registration of human genomic information: Law of Ukraine of 09.07.2022 No. 2391-IX. Retrieved from https://zakon.rada.gov.ua/laws/show/2391-20#Text

VERKHOVNA RADA OF UKRAINE. (2010). On the protection of personal data: Law of Ukraine of 01.06.2010 No. 2297-VI.Retrieved from https://zakon.rada.gov.ua/laws/show/2297-17#Text

VERKHOVNA RADA OF UKRAINE. (1992). On information: Law of Ukraine of 02.10.1992 No. 2657-XII. Retrieved from https://zakon.rada.gov.ua/laws/show/2657-12#Text

VERKHOVNA RADA OF UKRAINE. (2003). On electronic documents and electronic document management: Law of Ukraine of 22.05.2003 No. 851-IV. Retrieved from https://zakon.rada.gov.ua/laws/show/851-15#Text

VERKHOVNA RADA OF UKRAINE. (2020). On electronic communications: Law of Ukraine of 16.12.2020 No. 1089-IX.Retrieved from https://zakon.rada.gov.ua/laws/show/1089-20#Text

VERKHOVNA RADA OF UKRAINE. (2003). Civil Code of Ukraine: Law of 16.01.2003 No. 435-IV. Retrieved from https://zakon.rada.gov.ua/laws/card/435-15

VERKHOVNA RADA OF UKRAINE. (1992). Fundamentals of the Legislation of Ukraine on Healthcare: Law of Ukraine of 19 November 1992 No. 2801-XII. Retrieved from https://zakon.rada.gov.ua/laws/show/2801-12#Text.

UN EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANISATION (UNESCO). (1997). Universal Declaration on the Human Genome and Human Rights. Retrieved from https://www.ohchr.org/en/instruments-mechanisms/instruments/universal-declaration-human-genome-and-human-rights

WIENER, N. (1950). The human use of human beings: Cybernetics and society. Boston: Houghton Mifflin. Retrieved from https://books.google.com.ua/books/about/The_Human_Use_of_Human_Beings.html?id=QqwgAAAAMAAJ&redir_esc=y




DOI: http://dx.doi.org/10.26668/revistajur.2316-753X.v3i88.7747

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