Review of some innovations regarding clinical trials from the standpoint of human rights and intellectual property

In the article, the researchers reviewed some novelties in Ukrainian legislation related to clinical trials of medicinal products. The authors examine the issue of clinical trials of medicinal products from the standpoint of compliance with international standards and a positive vision of the novelties in domestic legislation through the prism of guaranteeing human rights in access to the latest medicinal products. The field of medicine is quite speculative, it is about people's lives and health, so the authors paid attention to the issue of intellectual property from the perspective of realization of the human right to health, inparticular, they considered the exclusivity of these materials of the registration dossier. The adoption of the Law of Ukraine “On Medicinal Products” № 2469-IX necessitates a review and study of the provisions relating to clinical trials of medicinal products in Ukraine from the perspective of human rights to health and certain issues of intellectual property law, as well as the compliance of the novelties with international standards. The article aims to draw the attention of the scientific community to the innovations in clinical trials of medicines in Ukraine in order to further develop the scientific doctrine for the comprehensive protection of human rights.The article reviews and pays attention to the innovations in clinical trials of medicines in two contexts:• guaranteeing human rights in access to the latest medicines and• ensuring the human right to health through the mechanisms of intellectual property rights.It was concluded that the presented innovations regarding clinical trials of medicinal products are the beginning of the progress towards harmonization with EU legislation. The study's forecasts confirmed that the novelties in the legislation are patient-oriented, the legislator seeks to ensure the human right to life and health and access to treatment by all possiblelegal mechanisms. It is advisable to continue further scientific research in the field of clinical trials of medicinal products in terms of approximation to EU legislation.

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Publication Details

Journal
Theory and Practice of Intellectual Property
Published
2025-03-27
DOI
https://doi.org/10.33731/1-22023.277345
Primary Topic
Science, Research, and Medicine
Type
article
Field-Weighted Citation Impact
0.00
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article

Review of some innovations regarding clinical trials from the standpoint of human rights and intellectual property

Олена Чомахашвілі, Olena Ponomarova
Theory and Practice of Intellectual Property
Science, Research, and Medicine
article

Review of some innovations regarding clinical trials from the standpoint of human rights and intellectual property

Олена Чомахашвілі, Olena Ponomarova
article en

Abstract

In the article, the researchers reviewed some novelties in Ukrainian legislation related to clinical trials of medicinal products. The authors examine the issue of clinical trials of medicinal products from the standpoint of compliance with international standards and a positive vision of the novelties in domestic legislation through the prism of guaranteeing human rights in access to the latest medicinal products. The field of medicine is quite speculative, it is about people's lives and health, so the authors paid attention to the issue of intellectual property from the perspective of realization of the human right to health, inparticular, they considered the exclusivity of these materials of the registration dossier. The adoption of the Law of Ukraine “On Medicinal Products” № 2469-IX necessitates a review and study of the provisions relating to clinical trials of medicinal products in Ukraine from the perspective of human rights to health and certain issues of intellectual property law, as well as the compliance of the novelties with international standards. The article aims to draw the attention of the scientific community to the innovations in clinical trials of medicines in Ukraine in order to further develop the scientific doctrine for the comprehensive protection of human rights.The article reviews and pays attention to the innovations in clinical trials of medicines in two contexts:• guaranteeing human rights in access to the latest medicines and• ensuring the human right to health through the mechanisms of intellectual property rights.It was concluded that the presented innovations regarding clinical trials of medicinal products are the beginning of the progress towards harmonization with EU legislation. The study's forecasts confirmed that the novelties in the legislation are patient-oriented, the legislator seeks to ensure the human right to life and health and access to treatment by all possiblelegal mechanisms. It is advisable to continue further scientific research in the field of clinical trials of medicinal products in terms of approximation to EU legislation.

Theory and Practice of Intellectual Property(1-2)
Human Growth Foundation (US)
Openalex Percentile: Top 91%
Science, Research, and Medicine
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