Legal Regulation of Biotechnology Use: Certain Perspectives for Legislative Reform
DOI:
https://doi.org/10.35774/app2026.01.140Keywords:
biotechnology, legal regulation, intellectual property, healthcare, pharmacyAbstract
From year to year, the value of the global biotechnology market is growing, which is associated with a number of factors, including the expansion of the areas of use of biotechnology (from agriculture, the food industry to medicine, pharmacy and even the fashion industry). At the same time, the legal regulation of biotechnology is fragmentary both at the level of national legislation and at the level of international legislation. The article analyzes the current legislation on the legal regulation of the use of biotechnology through the prism of the prospects for its reform and reform of the legislation of the European Union.
The research methodology is based on a complex combination of several methods. The comparative method is used to study the use of legal terminology, a doctrinal analysis of modern scientific literature is carried out, and individual legislative provisions are studied using the analysis and synthesis method.
The progress of the use of biotechnology in medicine and pharmacy requires the formation of an appropriate legal framework. The draft Civil Code of Ukraine (Code of Private Law) No. 14394 of 22.01.2026 in Article 308 proposes to enshrine the right of an individual to bodily integrity, including with regard to making decisions on biotechnological interventions. The EU is currently working on adopting a Regulation on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health, which will aim to strengthen the EU's competitiveness in the field of pharmaceuticals by removing regulatory barriers and creating an environment with uniform standards for clinical trials. In the context of legal protection of intellectual property rights for biotechnological inventions, the legal framework should contribute to achieving a balance between stimulating research, developing innovation and ensuring public interests in the field of health.
Downloads
References
1. Biotechnology Market (2024 – 2030). Retrieved from https://www.grandviewresearch.com/industry-analysis/biotechnology-market [in English]
2. The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation. Retrieved from https://www.precisionformedicine.com/blog/the-eu-biotech-act-what-sponsors-need-to-know-about-europes-biotechnology-transformation [in English]
3. All technical fields. Retrieved from https://www.epo.org/en/about-us/statistics/patent-index-2023/statistics-and-indicators/european-patent-applications/all-technical-fields [in English]
4. All technical fields. Retrieved from https://www.epo.org/en/about-us/statistics/patent-index-2024/statistics-and-indicators/european-patent-applications/all-technical-fields [in English]
5. Harrison, A,. & Thompson, S. (2025). Applications of Biotechnology in the Fashion Industry. Journal of Biotechnology (Australian Science Journals), 6(1), 15-28. DOI: https://doi.org/10.71465/ajbt2430 [in English]
6. Šovljanski, O., Tomić A., & Milović, T. et al. (2025). Construction Biotechnology: Integrating Bacterial Systems into Civil Engineering Practices. Microorganisms, 13(9), 1-29. DOI: 10.3390/microorganisms13092051 [in English]
7. Kurman, T. (2018). Pravovi zasady vykorystannia biotekhnolohii v umovakh staloho rozvytku silskohospodarskoho vyrobnytstva [Legal principles of the use of biotechnologies in the conditions of sustainable development of agricultural production]. Pidpryiemnytstvo, hospodarstvo i pravo – Business, Economics and Law, 7, 97-102 [in Ukrainian]
8. Bakai, Yu. Iu. (2026). Pravove rehuliuvannia vykorystannia biotekhnolohii u konteksti zabezpechennia prodovolchoi bezpeky [Legal regulation of biotechnology use in the context of food security]. Analityko-porivnialne pravoznavstvo – Analitical and Comparative Law, 2(1), 98-105. DOI: https://doi.org/10.24144/2788-6018.2026.01.2.15 [in Ukrainian]
9. Piddubnyi, O. Yu. (2011). Pravove rehuliuvannia rozvytku innovatsii u sferi biotekhnolohii. [Legal regulation of innovations development in the sphere of biotechnology]. Pravo. Liudyna. Dovkillia – Law. Human. Environment, 2 (3), 138–144 [in Ukrainian]
10. Piddubnyi, O. Yu. (2011). Teoretychni zasady formuvannia katehoriino-poniatiinoho aparatu pravovoho rehuliuvannia u sferi biotekhnolohii [Theoretical principles of formation of category-conceptual apparatus of legal regulation in the field of biotechnology]. Naukovyi visnyk Natsionalnoho universytetu bioresursiv i pryrodokorystuvannia Ukrainy. Seriia: Pravo – Scientific Bulletin of the National University of Life and Environmental Sciences of Ukraine, 165 (2), 136–143 [in Ukrainian]
11. Piddubnyi, O. Yu., & Svitlychnyi, O. P. (2022). Osnovy patentnoho zakhystu u sferi biotekhnolohii [Fundamentals of patent protection in the field of biotechnology]. Pravo. Liudyna. Dovkillia – Law. Human. Environment, 13(1), 43–49. DOI: 10.31548/law2022.01.005 [in Ukrainian]
12. Ustymenko, V. А., & Rossylna, O. V. (2024). Problems of Biotechnology Legal Regulation in the Field of Healthcare. Science and Innovation, 20 (2), 91-100 [in English]
13. Gupta, V., Sengupta, M., Prakash, J., & Tripathy, B. C. (2017). An Introduction to Biotechnology. Basic and Applied Aspects of Biotechnology [eds. V. Gupta et al.]. Singapore: Springer Nature Singapore, 1–21. DOI: 10.1007/978-981-10-0875-7_1 [in English]
14. Fári, M. G., & Kralovánszky, U. P. (2006). The founding father of biotechnology: Károly (Karl) Ereky. International Journal of Horticultural Science, 12 (1), 9–12. DOI: 10.31421/IJHS/12/1/614 [in English]
15. Konventsiia pro okhoronu biolohichnoho riznomanittia [Convention on Biological Diversity] vid 05.06.1992 r. Retrieved from https://zakon.rada.gov.ua/laws/show/995_030#Text [in Ukrainian]
16. Friedrichs, S., & van Beuzekom, B. (2018). Revised proposal for the revision of the statistical definitions of biotechnology and nanotechnology. OECD Science, Technology and Industry Working Papers, 1. DOI: https://doi.org/10.1787/085e0151-en [in English]
17. Pro derzhavne rehuliuvannia henetychno-inzhenernoi diialnosti ta derzhavnyi kontrol za rozmishchenniam na rynku henetychno modyfikovanykh orhanizmiv i produktsii: Zakon Ukrainy vid 23.08.2023 № 3339-IX [On State Regulation of Genetic Engineering Activities and State Control over the Placing on the Market of Genetically Modified Organisms and Products]. Retrieved from https://zakon.rada.gov.ua/go/3339-20 [in Ukrainian]
18. Pro likarski zasoby: Zakon Ukrainy vid 28.07.2022 № 2469-IX. [On Medicinal Products: Law of Ukraine dated July 28, 2022 № 2469-IX]. Retrieved from https://zakon.rada.gov.ua/go/2469-20 [in Ukrainian]
19. Pro skhvalennia Stratehii tsyfrovoho rozvytku innovatsiinoi diialnosti Ukrainy na period do 2030 roku ta zatverdzhennia operatsiinoho planu zakhodiv z yii realizatsii u 2025-2027 rokakh: Rozporiadzhennia Kabinetu Ministriv Ukrainy vid 31 hrudnia 2024 r. № 1351-r [Order of the Cabinet of Ministers of Ukraine [On Approval of the Strategy for Digital Development of Innovation Activity in Ukraine for the Period up to 2030 and Approval of the Operational Action Plan for its Implementation in 2025-2027]. Retrieved from https://zakon.rada.gov.ua/go/1351-2024-%D1%80 [in Ukrainian]
20. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Retrieved from https://eur-lex.europa.eu/eli/dir/2001/18/oj/eng [in English]
21. Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. Retrieved from https://eur-lex.europa.eu/eli/reg/2003/1830/oj/eng [in English]
22. Оpinion of the Economic and Social Committee on the Proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions. Retrieved from https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:51996AC0878:EN:HTML [in English]
23. Barraza-Botet, C., Nadal, D., Rosen, M., & Winickoff, D. (2026). A comparison of the innovation and regulatory environments for biotechnology and biosolutions across the European Union and the United States. Paris: OECD Publishing, 2026. DOI: 10.1787/1ec20342-en [in English]
24. Proekt Tsyvilnoho kodeksu Ukrainy [Project of Civil Code of Ukraine] № 14394 vid 22.01.2026 r. Retrieved from https://itd.rada.gov.ua/billinfo/Bills/Card/69528 [in English]
25. Liu, D., Cao, D., & Han, R. (2021). Recent advances in therapeutic gene-editing technologies. Therapeutic Delivery, 12 (7), 517–536. DOI: 10.4155/tde-2021-0023 [in English]
26. Boards of Appeal EPO (2024). T 1553/22 (Human-pig chimeras/UNIVERSITY OF MINNESOTA) 04-09-2024. Retrieved from https://www.epo.org/en/boards-of-appeal/decisions/t221553eu1 [in English]
27. Act on human medical use of biotechnology etc. (Biotechnology Act)) LOV-2003-12-05-100. Retireved from https://bwcimplementation.org/sites/default/files/resource/NO_Biotechnology%20Act%20-%202003_EN.pdf [in English]
28. Proposal for a Regulation to establish measures to strengthen the Union's biotechnology and biomanufacturing sectors (European Biotech Act). Retrieved from https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en [in English]
Downloads
Published
Issue
Section
License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
