![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-734x1024.jpg\")
<\/figure>\n\n\n\nTheory and practice of intellectual property
\u2116 2 \/ 2021<\/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\/22021.236550<\/a><\/p>\n\n\n\n Published \u00a0\u00a0\u00a0\u00a0\u00a02021-05-14<\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n<\/div>\n\n\n\n Managed entry agreements as a new legal framework for Oleksandr Zosymenko<\/strong> <\/p>\n\n\n\n Abstract Ukraine, in responding to the COVID-19 pandemic, has reviewed the legal mechanisms for access to medicines contained in national legislation and had taken the first steps towards implementing managed access agreements.<\/p>\n\n\n\n Ukrainian legislation did not contain such a concept as a managed entry agreement by March 2020, and such agreement was never used in Ukrainian contract practice for the purchase of medicines. On March 17, 2020, changes were made to the national legislation, namely the Law of Ukraine \u00abOn amendments to certain laws of Ukraine aimed at increasing the availability of medicines, medical products and their accessories, which are purchased by the person authorized to carry out purchases in the field of health care\u00bb which were amended, in particular, to the Law of Ukraine \u00abFundamentals of the legislation of Ukraine on health care\u00bb and supplemented by article 791 of which a managed entry agreement to national legislation was introduced.<\/p>\n\n\n\n The provision of Article 79-1 of the Fundamentals of the legislation of Ukraine on health care regarding the parties, subject matter, content of managed entry agreements is analysed.<\/p>\n\n\n\n January 27, 2021, the Cabinet of Ministers of Ukraine adopted a decision approving the procedure for the negotiation, execution, modification and termination of managed entry agreement. A standard form of agreement for a managed entry agreement has been approved. The managed entry agreements procedure has been introduced in Ukraine February 15, 2021.<\/p>\n\n\n\n The legal and regulatory provisions concerning managed entry agreements have been analysed and highlighted their particularities.<\/p>\n\n\n\n Keywords: <\/strong>managed entry agreements, availability of medicines, original medicines, purchase of medicines, medicinal immunobiological drugs<\/p>\n\n\n\n References<\/strong><\/p>\n\n\n\n \u0417\u0430\u0431\u0435\u0437\u043f\u0435\u0447\u0435\u043d\u043d\u044f \u043f\u0430\u0446\u0456\u0454\u043d\u0442\u0456\u0432 \u0456\u043d\u043d\u043e\u0432\u0430\u0446\u0456\u0439\u043d\u0438\u043c\u0438 \u043b\u0456\u043a\u0430\u043c\u0438 \u0437 \u0432\u0438\u043a\u043e\u0440\u0438\u0441\u0442\u0430\u043d\u043d\u044f\u043c \u0434\u043e\u0433\u043e\u0432\u043e\u0440\u0456\u0432 \u043a\u0435\u0440\u043e\u0432\u0430\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u0442\u0443\u043f\u0443. \u041e\u0441\u043d\u043e\u0432\u0438 \u0437\u0430\u043a\u043e\u043d\u043e\u0434\u0430\u0432\u0441\u0442\u0432\u0430 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u043f\u0440\u043e \u043e\u0445\u043e\u0440\u043e\u043d\u0443 \u0437\u0434\u043e\u0440\u043e\u0432\u2019\u044f : \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 19 \u043b\u0438\u0441\u0442\u043e\u043f\u0430\u0434\u0430 1992 \u0440\u043e\u043a\u0443 \u2116 2801-\u0425\u0406\u0406. \u041a\u0430\u0448\u0438\u043d\u0446\u0435\u0432\u0430 \u041e. \u042e. \u041f\u0440\u0430\u0432\u043e\u0432\u0456 \u043c\u0435\u0445\u0430\u043d\u0456\u0437\u043c\u0438 \u0440\u043e\u0437\u0448\u0438\u0440\u0435\u043d\u043d\u044f \u0434\u043e\u0441\u0442\u0443\u043f\u0443 \u0434\u043e \u043b\u0456\u043a\u0443\u0432\u0430\u043d\u043d\u044f \u0431\u0440\u0435\u043d\u0434\u043e\u0432\u0438\u043c\u0438 \u0442\u0430 \u0433\u0435\u043d\u0435\u0440\u0438\u0447\u043d\u0438\u043c\u0438 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u043c\u0438 \u0437\u0430\u0441\u043e\u0431\u0430\u043c\u0438 \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456. \u0414\u0435\u043c\u0447\u0435\u043d\u043a\u043e \u0406. \u0421. \u0414\u043e\u0433\u043e\u0432\u043e\u0440\u0438 \u043a\u0435\u0440\u043e\u0432\u0430\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u0442\u0443\u043f\u0443: \u0437\u0430\u0433\u0430\u043b\u044c\u043d\u0430 \u0445\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0430. \u041f\u0456\u0434\u043f\u0440\u0438\u0454\u043c\u0441\u0442\u0432\u043e, \u0433\u043e\u0441\u043f\u043e\u0434\u0430\u0440\u0441\u0442\u0432\u043e \u0456 \u043f\u0440\u0430\u0432\u043e. 2020. \u2116 8. \u0421.76\u221281.<\/p>\n\n\n\n \u0414\u0435\u044f\u043a\u0456 \u043f\u0438\u0442\u0430\u043d\u043d\u044f \u0449\u043e\u0434\u043e \u0434\u043e\u0433\u043e\u0432\u043e\u0440\u0456\u0432 \u043a\u0435\u0440\u043e\u0432\u0430\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u0442\u0443\u043f\u0443 \u0442\u0430 \u0437\u0443\u043f\u0438\u043d\u0435\u043d\u043d\u044f \u0434\u0456\u0457 \u0430\u0431\u0437\u0430\u0446\u0443 \u043f\u0435\u0440\u0448\u043e\u0433\u043e \u043f\u0443\u043d\u043a\u0442\u0443 12 \u043f\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u0438 \u041a\u0430\u0431\u0456\u043d\u0435\u0442\u0443 \u041c\u0456\u043d\u0456\u0441\u0442\u0440\u0456\u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 25 \u0431\u0435\u0440\u0435\u0437\u043d\u044f 2009 \u0440. \u2116 333 : \u043f\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u041a\u0430\u0431\u0456\u043d\u0435\u0442\u0443 \u041c\u0456\u043d\u0456\u0441\u0442\u0440\u0456\u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 27 \u0441\u0456\u0447\u043d\u044f 2021 \u0440\u043e\u043a\u0443 \u2116\u200861. \u041f\u043e\u0440\u044f\u0434\u043a\u043e\u043a \u0443\u043a\u043b\u0430\u0434\u0435\u043d\u043d\u044f, \u0432\u0438\u043a\u043e\u043d\u0430\u043d\u043d\u044f, \u0437\u043c\u0456\u043d\u0438 \u0442\u0430 \u043f\u0440\u0438\u043f\u0438\u043d\u0435\u043d\u043d\u044f \u0434\u043e\u0433\u043e\u0432\u043e\u0440\u0456\u0432 \u043a\u0435\u0440\u043e\u0432\u0430\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u0442\u0443\u043f\u0443 : \u043f\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u041a\u0430\u0431\u0456\u043d\u0435\u0442\u0443 \u041c\u0456\u043d\u0456\u0441\u0442\u0440\u0456\u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 27 \u0441\u0456\u0447\u043d\u044f 2021 \u0440\u043e\u043a\u0443 \u2116\u200861. Theory and practice of intellectual property\u2116 2 \/ 2021 ISSN (Print) 2308-0361ISSN (Online) 2519-2744 DOI: https:\/\/doi.org\/10.33731\/22021.236550 Published \u00a0\u00a0\u00a0\u00a0\u00a02021-05-14 Managed entry agreements as a new legal framework foraccess to medicines Oleksandr ZosymenkoUkrainehttps:\/\/orcid.org\/0000-0001-6375-0691 AbstractThe article concerns the new provisions of national legislative a legal mechanism for access to medicines, namely managed entry agreements. The use of managed […]<\/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-9643","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/9643","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=9643"}],"version-history":[{"count":4,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/9643\/revisions"}],"predecessor-version":[{"id":9980,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/9643\/revisions\/9980"}],"wp:attachment":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/media?parent=9643"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2025\/11\/CC-2.png\")
<\/figure>\n\n\n\n
access to medicines<\/strong><\/p>\n\n\n\n
Ukraine
https:\/\/orcid.org\/0000-0001-6375-0691<\/a><\/p>\n\n\n\n
<\/strong>The article concerns the new provisions of national legislative a legal mechanism for access to medicines, namely managed entry agreements. The use of managed entry agreements in European contract practice is widespread.<\/p>\n\n\n\n
https:\/\/xn--h1adc2i.xn--j1amh\/news\/021120-7.html<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/2801-12#Text<\/a><\/p>\n\n\n\n
https:\/\/medcom.unba.org.ua\/publications\/5726-pravovi-mehanizmi-rozshirennya-dostupu-do-likuvannya-brendovimi-ta-generichnimi-likars-kimi-zasobami-v-ukraini.html<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/61-2021-%D0%BF#Text<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/61-2021-%D0%BF#Text<\/a><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"