The article is dedicated to the analysis of protection of a trade secret related to the manufacture of biological medicinal products in correlation with the interests of the society under war.

The purpose of the article is to study the legal and ethical aspects of protection of intellectual property rights to a trade secret related to the manufacture of biological medicinal products from the perspective of providing access to medications under martial law.

The article analyzes the legal regulation of protecting the intellectual property rights of manufacturers of biological medicinal products by obtaining patents for inventions and protecting trade secrets; studies the specific features of legal protection of intellectual property rights to subjects of patenting and intellectual property rights to trade secrets in pharmacy; provides legal analysis of the concept of a biologics and a biosimilar; identifies the risks of classifying the information about the manufacture processes of biological medicinal products as a trade secret in the context of delaying the market entry of biosimilars and therefore negative consequences for access to treatment.

To cater for the society interest in access to medications during the war, and to address the most important national security interests in the protection of fundamental human rights to life and health, Ukraine can have recourse to the flexible provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which allow to deviate from the assumed obligations.

The high relevance of the state’s provision of people’s access to medications arises from the armed conflict where Ukraine is a victim, as a result of which its health care system is facing considerable challenges. The article provides recommendations on how to reform the laws by elaborating the necessary legal standards related to protecting trade secrets of manufacturers of biological medicinal products from the viewpoint of rethinking the paradigm of intellectual property rights in pharmacy in favor of taking the model of natural human rights as a prevalent one and preventing the monopolization of knowledge in socially significant areas, to which medicine and pharmacy belong.

Bibliography

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Websites

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8. ‘Overview for Health Care Professionals’ (U.S. Food and Drug, 13.12.2022) <https:// www.fda.gov/drugs/biosimilars/overview-health-care-professionals> (accessed: 28.02.2023) (in English).

9. Bauer Matt, ‘The Risk of Pervasive Trade Secret Practices Within the Life Sciences’ (Bill of Health, 18.02.2022) <https://blog.petrieflom.law.harvard.edu/2022/02/18/theriskof-pervasive-trade-secret-practices-within-the-life-sciences> (accessed: 28.02.2023) (in English).

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