Public law regulation of biomedical technologies: the Norwegian experience

A comparative study of the legal regulation of biomedical technologies is conducted. The purpose of the study is to conduct a legal examination of the Norwegian experience, which is an example of a conservative approach based on the most careful permission for innovation in such a sensitive area. The main provisions of the Law of December 5, 2003, No. 100 “On the Medical Use of Biotechnology, etc. (Biotechnology Law)” are analyzed in detail. This law is based on the observance of universal principles in biomedicine – respect for human dignity, observance of human rights and personal inviolability, non-discrimination on the basis of heredity, promotion of the principles of bioethics. The main restrictions imposed on medical workers when implementing assisted reproductive technologies are shown. For example, Norway is a country where surrogacy is prohibited, and the birth of children using assisted reproduction is possible only after a thorough examination of the couple for the possibility of raising a child in appropriate conditions. Special requirements are presented for obtaining consent for the use of various biological objects (tissues, human cells, aborted material) for research purposes. It is highlighted that special legislation is in force that determines the legal regime of biobanks. It is concluded that the presence of strict rules correlates with the level of high trust in the public health system.

law regulation, biomedical technologies, genomic medicine, transplantology, Norway

1. Brunner H.G., Nelen M., Breakefield X.O., Ropers H.H., van Oost B.A. Abnormal behavior associated with a point mutation in the structural gene for monoamine oxidase A // Science. 1993. Vol. 262. № 5133. Р. 578-580. https://doi.org/10.1126/science.8211186

2. McDermott R., Tingley D., Cowden J., Frazzetto G., Johnson D.D.P. Monoamine oxidase A gene (MAOA) predicts behavioral aggression following provocation // Proceedings of the National Academy of Sciences of the United States of America. 2009. Vol. 106. № 7. Р. 2118-2123. https://doi.org/10.1073/pnas.0808376106

3. Bhoi S., Sarangi P., Pradhan L.K., Sahoo P.K., Sahoo B.S., Aparna S., Raut S., Das S.K. Bisphenol F-induced precocious genesis of aggressive neurobehavioral response is associated with heightened monoamine oxidase activity and neurodegeneration in zebrafish brain // Neurotoxicology and Teratology. 2024. Vol. 106. Art. 107402. https://doi.org/10.1016/j.ntt.2024.107402

4. Зоричева А.С., Звонова Е.А., Агапова Л.С., Лыкова М.С., Маркова О.А., Леонов В.С. Опыт производства и клинического применения биомедицинского клеточного продукта Изитенс® для восстановления повреждений хрящевой ткани коленного сустава человека // БИОпрепараты. Профилактика, диагностика, лечение. 2024. Т. 24. № 2. С. 172-187. https://doi.org/10.30895/2221-996X-2024-24-2-172-187, https://elibrary.ru/oosrku

5. Sundby J. Infertility in public health: the case of Norway // Facts, Views & Vision in ObGyn. 2010. Vol. 2. № 3. Р. 177-181.

6. Романовская О.В. Генетическое консультирование в семейном праве // Гражданин и право. 2014. № 12. С. 71-80. https://elibrary.ru/tctfvx

7. Goisis A., Håberg S.E., Hanevik H.I., Magnus M.C., Kravdal Ø. The demographics of assisted reproductive technology births in a Nordic country // Human Reproduction. 2020. № 35 (6). Р. 1441-1450. https://doi.org/10.1093/humrep/deaa055

8. Johannessen J., Nærland T., Hope S., Torske T., Høyland A.L., Strohmaier J., Heiberg A., Rietschel М., Djurovic S., Andreassen Ole A., Butler Merlin G. Parents’ Attitudes toward clinical genetic testing for autism spectrum disorder – data from a Norwegian sample // International Journal of Molecular Sciences. 2017. Vol. 18. № 5. Art. 1078. https://doi.org/10.3390/ijms18051078

9. Von Krogh A.S., Waage A., Quist-Paulsen P. Kongenital trombotisk trombocytopenisk purpura // Tidsskr Nor Legeforen. 2016. № 136. Р. 1452-1457. https://doi.org/10.4045/tidsskr.15.1272

10. Prescott Т. Skal friske barn testes for genetisk sykdomsdisposisjon? // Tidsskr Nor Legeforen. 2016. № 136. Р. 1421.

11. Экономическое право / под науч. ред. Н.С. Бондаря. М.: Проспект, 2021. 352 с. https://doi.org/ 10.31085/9785392336791-2021-352, https://elibrary.ru/iymonq