![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-734x1024.jpg\")
<\/figure>\n\n\n\nTheory and practice of intellectual property
\u2116 1-2 \/ 2023<\/p>\n\n\n\n
ISSN (Print) 2308-0361
ISSN (Online) 2519-2744<\/p>\n\n\n\n
![\"\"](\"https:\/\/test.inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153.png\"){kind=icon}
PDF (Ukrainian)<\/a><\/div>\n<\/div>\n\n\n\nDOI: https:\/\/doi.org\/10.33731\/1-22023.277345<\/a><\/p>\n\n\n\n Submitted 2023-02-17 <\/p>\n\n\n\n <\/p>\n<\/div>\n\n\n\n Review of some innovations regarding clinical trials from the standpoint of human rights and intellectual property<\/strong><\/p>\n\n\n\n Olena Ponomarova<\/strong> Olena Chomakhashvili<\/strong> Abstract The adoption of the Law of Ukraine \u00abOn Medicinal Products\u00bb 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.<\/p>\n\n\n\n The article reviews and pays attention to the innovations in clinical trials of medicines in two contexts: 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.<\/p>\n\n\n\n Keywords: <\/strong>clinical trials, medicinal product, data exclusivity, intellectual property, human rights, human health, public health<\/p>\n\n\n\n References<\/strong><\/p>\n\n\n\n \u041f\u0440\u043e \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438 : \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 28.07.2022 \u2116 2469-IX. \u0423\u0433\u043e\u0434\u0430 \u043f\u0440\u043e \u0430\u0441\u043e\u0446\u0456\u0430\u0446\u0456\u044e \u043c\u0456\u0436 \u0423\u043a\u0440\u0430\u0457\u043d\u043e\u044e, \u0437 \u043e\u0434\u043d\u0456\u0454\u0457 \u0441\u0442\u043e\u0440\u043e\u043d\u0438, \u0442\u0430 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u0438\u043c \u0421\u043e\u044e\u0437\u043e\u043c, \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u0438\u043c \u0441\u043f\u0456\u0432\u0442\u043e\u0432\u0430\u0440\u0438\u0441\u0442\u0432\u043e\u043c \u0437 \u0430\u0442\u043e\u043c\u043d\u043e\u0457 \u0435\u043d\u0435\u0440\u0433\u0456\u0457 \u0456 \u0457\u0445\u043d\u0456\u043c\u0438 \u0434\u0435\u0440\u0436\u0430\u0432\u0430\u043c\u0438-\u0447\u043b\u0435\u043d\u0430\u043c\u0438, \u0437 \u0456\u043d\u0448\u043e\u0457 \u0441\u0442\u043e\u0440\u043e\u043d\u0438. \u041f\u0440\u043e \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438 : \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 04.04.1996 \u2116 123\/96-\u0412\u0420. \u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 (\u0404\u0421) \u2116 726\/2004 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u043e\u0433\u043e \u041f\u0430\u0440\u043b\u0430\u043c\u0435\u043d\u0442\u0443 \u0442\u0430 \u0420\u0430\u0434\u0438 \u0432\u0456\u0434 31 \u0431\u0435\u0440\u0435\u0437\u043d\u044f 2004 \u0440\u043e\u043a\u0443, \u0449\u043e \u0432\u0441\u0442\u0430\u043d\u043e\u0432\u043b\u044e\u0454 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0438 \u0421\u043e\u044e\u0437\u0443 \u0434\u043b\u044f \u0430\u0432\u0442\u043e\u0440\u0438\u0437\u0430\u0446\u0456\u0457 \u0442\u0430 \u043d\u0430\u0433\u043b\u044f\u0434\u0443 \u0437\u0430 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u043c\u0438 \u0437\u0430\u0441\u043e\u0431\u0430\u043c\u0438 \u0434\u043b\u044f \u043b\u044e\u0434\u0438\u043d\u0438 \u0442\u0430 \u0437\u0430\u0441\u043d\u0443\u0432\u0430\u043d\u043d\u044f \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u043e\u0433\u043e \u0430\u0433\u0435\u043d\u0442\u0441\u0442\u0432\u0430 \u0437 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432. Compassionate use. European Medicines Agency. The supply of unlicensed medicinal products (\u00abspecials\u00bb). \u0421\u043f\u0440\u0430\u0432\u0430 \u0404\u0421\u041f\u041b \u2116 47039\/11 \u0442\u0430 358\/12 \u00ab\u0425\u0440\u0438\u0441\u0442\u043e\u0437\u043e\u0432 \u0442\u0430 \u0456\u043d\u0448\u0456 \u043f\u0440\u043e\u0442\u0438 \u0411\u043e\u043b\u0433\u0430\u0440\u0456\u0457\u00bb (Hristozov and Others V. Bulgaria). \u041f\u043e\u044f\u0441\u043d\u044e\u0432\u0430\u043b\u044c\u043d\u0430 \u0437\u0430\u043f\u0438\u0441\u043a\u0430 \u0434\u043e \u043f\u0440\u043e\u0454\u043a\u0442\u0443 \u0417\u0430\u043a\u043e\u043d\u0443 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u00ab\u041f\u0440\u043e \u0456\u043d\u0441\u0442\u0438\u0442\u0443\u0442 \u0440\u0435\u0454\u0441\u0442\u0440\u043e\u0432\u0430\u043d\u0438\u0445 \u043f\u0430\u0440\u0442\u043d\u0435\u0440\u0441\u0442\u0432\u00bb \u2116 9103 \u0432\u0456\u0434 13.03.2023. India: Data Exclusivity. \u0423\u0433\u043e\u0434\u0430 \u043f\u0440\u043e \u0442\u043e\u0440\u0433\u043e\u0432\u0435\u043b\u044c\u043d\u0456 \u0430\u0441\u043f\u0435\u043a\u0442\u0438 \u043f\u0440\u0430\u0432 \u0456\u043d\u0442\u0435\u043b\u0435\u043a\u0442\u0443\u0430\u043b\u044c\u043d\u043e\u0457 \u0432\u043b\u0430\u0441\u043d\u043e\u0441\u0442\u0456. Theory and practice of intellectual property\u2116 1-2 \/ 2023 ISSN (Print) 2308-0361ISSN (Online) 2519-2744 DOI: https:\/\/doi.org\/10.33731\/1-22023.277345 Submitted 2023-02-17Accepted 2023-03-24Published 2023-03-27 Review of some innovations regarding clinical trials from the standpoint of human rights and intellectual property Olena PonomarovaPh.D. (Law), Senior Researcher at the Department for Research on Intellectual Property Rights and Human […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-8801","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8801","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/comments?post=8801"}],"version-history":[{"count":3,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8801\/revisions"}],"predecessor-version":[{"id":8804,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8801\/revisions\/8804"}],"wp:attachment":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/media?parent=8801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Accepted 2023-03-24
Published 2023-03-27<\/p>\n\n\n\n![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2025\/11\/CC-2.png\")
<\/figure>\n\n\n\n
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<\/a><\/p>\n\n\n\n
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<\/a><\/p>\n\n\n\n
<\/strong>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.<\/p>\n\n\n\n
– guaranteeing human rights in access to the latest medicines and
– ensuring the human right to health through the mechanisms of intellectual property rights.<\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/2469-20#Text<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/984_011#Text<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/123\/96-%D0%B2%D1%80#Text<\/a><\/p>\n\n\n\n
https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0726-20220128<\/a><\/p>\n\n\n\n
https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use<\/a><\/p>\n\n\n\n
https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/373505\/The_supply_of_unlicensed_medicinal_products__specials_.pdf<\/a><\/p>\n\n\n\n
https:\/\/hudoc.echr.coe.int\/fre#{%22itemid%22:[%22002-7298%22]}<\/a><\/p>\n\n\n\n
https:\/\/itd.rada.gov.ua\/billInfo\/Bills\/pubFile\/1681896<\/a><\/p>\n\n\n\n
https:\/\/www.mondaq.com\/india\/information-security–risk-management\/79418\/data-exclusivity<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/981_018#Text<\/a><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"