Gene editing technologies are developing at ever-increasing pace. A large number of scientific publications on the progress, existing problems and prospects of human genome editing indicate high expectations for the advancement of research in this area and the possibilities of modifying the human genome, for example, for medical purposes. The intensive development of genome editing technologies opens up revolutionary possibilities for widespread use and at the same time creates uncertainty and fear of the human genome editing’s consequences. The problems of legal regulation in this area are largely related to a number of bioethical issues related to human genome editing, namely the ethics and limits of interference with human nature and the possibility of changing it.

The article aims to study the legal regulation of human genome editing, identifying the undetermined aspects of it with further steps to propose the solution considering the necessity to protect the fundamental human right to health care that could benefit from the application of such technologies.

USA, Australia, New Zealand and a considerable number of the EU countries’ national acts prohibit human germline editing. Legal provisions to prohibit such actions are explained by the fact that humanity currently does not have sufficient knowledge about the possible consequences of editing the germline and fears are raised that the modification of the genome which could be passed on to future generations may lead to practices that violate human rights and undermine the principles of respect for human dignity, justice, and equality.

The analysis showed that legal regulation of human genome editing needs to be improved in Ukraine. The complex approach is required to form a legislative framework considering different aspects of the application of human genome modification that were analyzed in the article, namely:

– as a component of the right to health through the use of biotechnology in medicine and pharmacy, gene therapy, and ensuring wide access to effective methods and means of preventing, diagnosing, and treating diseases;

 – as the fulfillment of the duty of the state to preserve the gene pool of the Ukrainian people;

– as an element of national security (in particular biosecurity) to assess the risks of editing the human genome as a technology to improve (or worsen) human potential with the subsequent development of policies, including legal, to identify/prevent/confront possible risks;

 – in the context of intellectual property development to stimulate investment and innovation in science, taking into account the priority of fundamental human rights.

Bibliography

Journal articles

1. Badea A R, Feeney O, ‘Genome Editing Dilemma: Navigating Dual-Use Potential and Charting the Path Forward’ [2024] Bioethical Inquiry https://doi.org/10.1007/s11673-02410358-8.

2. Cetin B, Erendor F, Eksi Y E, Sanlioglu A D, Sanlioglu S, ‘Gene and cell therapy of human genetic diseases: Recent advances and future directions’ [2024] 28(17) Journal of Cellular and Molecular Medicine 1–15.

3. Kim D, Hilty R, E Hofmeister, P R Slowinski, M Steinhart, ‘CRISPR/Cas Technology and Innovation: Mapping Patent Law Issues’ [2022] 22-06 Max Planck Institute for Innovation & Competition Research Paper 1–49.

 4. Kim Y, Landstrom A P, Shah S H, Wu J C, Seidman C E, ‘Gene Therapy in Cardiovascular Disease: Recent Advances and Future Directions in Science: A Science Advisory From the American Heart Association’ [2024] 150(23) Circulation 471–480.

5. Legato M J, Church G M, Greely H T et al, ‘Editing the Human Genome: Progress and Controversies’ [2017] 1(1) Gender and the Genome 4–11 doi:10.1089/gg.2016.29001.rtl.

 6. van Beers B C, ‘Rewriting the human genome, rewriting human rights law? Human rights, human dignity, and human germline modification in the CRISPR era’ [2020] 7(1) The Journal of Law and the Biosciences 1–36.

7. Wang L, Liang X, Zhang W, ‘Genome editing and human rights: Implications of the UNGPs’ [2022] 4(6) Biosafety and Health 386–391.

8. Krushelnytska L, ‘Ekonomiko-pravovi zasady medyko-henetychnoi dopomohy v Ukraini’ [2024] 3 Kyivskyi chasopys prava 150–157 (in Ukrainian).

9. Piddubnyi O, Marits D, Yehorova V, Chepulchenko T, Vladykin O, Ethical and legal aspects of editing a patient’s genome for non-medical purposes [2023] 6(4) Social and Legal Studios 174–182 (in Ukrainian).

Websites

10. [Latest] Global Genetic Engineering Market Size/Share Worth USD 2,917.2 Million by 2033 at a 6.74% CAGR: Custom Market Insights (Analysis, Outlook, Leaders, Report, Trends, Forecast, Segmentation, Growth, Growth Rate, Value) <https://www.globenewswire.com/ news-release/2024/08/09/2927525/0/en/Latest-Global-Genetic-Engineering-Market-SizeShare-Worth-USD-2-917-2-Million-by-2033-at-a-6-74-CAGR-Custom-Market-InsightsAnalysis-Outlook-Leaders-Report-Trends-Forecast-Segmenta.html> (accessed 07.02.2025).

11. Davies K, ‘FDA Approves Casgevy, the First CRISPR Therapy, for Sickle Cell Disease’ <https://www.genengnews.com/topics/genome-editing/fda-approves-the-first-crisprtherapyfor-sickle-cell-disease> (accessed 07.02.2025).

12. Genome editing in humans. A survey of law, regulation and governance principles <https:// www.europarl.europa.eu/RegData/etudes/STUD/2022/729506/EPRS_STU(2022)729506_ EN.pdf> (accessed 12.02.2025).

13. Genome <https://www.genome.gov/genetics-glossary/Genome > (accessed 07.02.2025).

14. Nobel Prizes 2020 <https://www.nobelprize.org/all-nobel-prizes-2020> (accessed 07.02.2025).

15. Ramos G I, ‘Ethics of the Genome Editing Roundtable’ (February 11, 2022) <https:// gabrielailianramos.wordpress.com/2022/02/11/ethics-of-the-genome-editing-roundtable> (accessed 07.02.2025).

16. Roundtable on the ethics of gene editing, Brussels <https://www.eumonitor.eu/9353000/1/ j9vvik7m1c3gyxp/vl1ea9cge3qm?ctx=vg9pir5eze8o&v=1&tab=2&n=23> (accessed 07.02.2025).

17. UK medicines regulator approves world-first gene-editing treatment for blood disorders <https://www.imperial.nhs.uk/about-us/news/uk-medicines-regulator-approves-world-firstgeneediting-treatment-for-blood-disorders> (accessed 07.02.2025).