Theory and practice of intellectual property
№ 1-2 / 2023

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/1-22023.277345

Submitted     2023-02-17
Accepted      2023-03-24
Published      2023-03-27

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

Olena Ponomarova
Ph.D. (Law), Senior Researcher at the Department for Research on Intellectual Property Rights and Human Rights in Healthcare of the Intellectual Property Scientific Research Institute of the National Academy of Legal Sciences of Ukraine
Ukraine
https://orcid.org/0000-0002-8232-3748

Olena Chomakhashvili
Ph.D. (Law), Associate Professor, Leading Researcher at the Department for Research on Intellectual Property Rights and Human Rights in Healthcare of the Intellectual Property Scientific Research Institute of the National Academy of Legal Sciences of Ukraine
Ukraine
https://orcid.org/0000-0002-0546-2138

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, in particular, they considered the exclusivity of these materials of the registration dossier.

The adoption of the Law of Ukraine «On Medicinal Products» No 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 possible legal 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.

Keywords: clinical trials, medicinal product, data exclusivity, intellectual property, human rights, human health, public health

References

Про лікарські засоби : Закон України від 28.07.2022 № 2469-IX.
https://zakon.rada.gov.ua/laws/show/2469-20#Text

Угода про асоціацію між Україною, з однієї сторони, та Європейським Союзом, Європейським співтовариством з атомної енергії і їхніми державами-членами, з іншої сторони.
https://zakon.rada.gov.ua/laws/show/984_011#Text

Про лікарські засоби : Закон України від 04.04.1996 № 123/96-ВР. 
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Регламент (ЄС) № 726/2004 Європейського Парламенту та Ради від 31 березня 2004 року, що встановлює процедури Союзу для авторизації та нагляду за лікарськими засобами для людини та заснування Європейського агентства з лікарських засобів.
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Compassionate use. European Medicines Agency.
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The supply of unlicensed medicinal products («specials»).
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf

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Пояснювальна записка до проєкту Закону України «Про інститут реєстрованих партнерств» № 9103 від 13.03.2023.
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India: Data Exclusivity.
https://www.mondaq.com/india/information-security–risk-management/79418/data-exclusivity

Угода про торговельні аспекти прав інтелектуальної власності.
https://zakon.rada.gov.ua/laws/show/981_018#Text