{"id":788989,"date":"2024-02-28T11:24:44","date_gmt":"2024-02-28T09:24:44","guid":{"rendered":""},"modified":"2025-02-06T12:47:39","modified_gmt":"2025-02-06T10:47:39","slug":"v-ukrayini-zaversheno-zakonodavche-vregulyuvannya-program-nadannya-patsiyentam-likarskyh-zasobiv-zi-spivchuttya","status":"publish","type":"post","link":"https:\/\/new.eba.com.ua\/en\/v-ukrayini-zaversheno-zakonodavche-vregulyuvannya-program-nadannya-patsiyentam-likarskyh-zasobiv-zi-spivchuttya\/","title":{"rendered":"Ukraine finalizes legislative regulation of compassionate use programs for patients"},"content":{"rendered":"<p><span data-preserver-spaces=\"true\">Regulation of the requirements for compassionate use programs is a crucial legislative change to enable such programs in Ukraine and improve access to innovative medicines for seriously ill patients. Amendments to the Tax Code of Ukraine (TCU) became the final chord in the compassionate use programs regulation.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">It is worth noting that this settlement was initiated and participated by representatives of the EBA Healthcare Committee&#8217;s Clinical Trials Subcommittee in the preparation and implementation of this project, including the analysis of international legislation, in particular the EU, with the selection of an appropriate concept for Ukraine, development of proposals for amendments to the laws of Ukraine together with legal partners and experts of EBA member companies, cooperation with MPs of Ukraine and VRU committees to support the legislative initiative led by Valerii Zub.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">The settlement took place in several stages, including adoption:<\/span><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">Requirements for conducting compassionate programs <\/span><a class=\"editor-rtfLink\" href=\"https:\/\/w1.c1.rada.gov.ua\/pls\/zweb2\/webproc4_1?pf3511=72437\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">(Draft Law No. 5736<\/span><\/a><span data-preserver-spaces=\"true\">, adopted by the Verkhovna Rada on February 15, 2022),<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">The Procedure for Approval and Conduct of Compassionate Programs (approved by\u00a0<\/span><a class=\"editor-rtfLink\" href=\"https:\/\/zakon.rada.gov.ua\/laws\/show\/z1270-22#Text\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">Order of the Ministry of Health No. 1525 dated August 24, 2022<\/span><\/a><span data-preserver-spaces=\"true\">).<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">Amendments to the Tax Code (relevant\u00a0<\/span><a class=\"editor-rtfLink\" href=\"https:\/\/itd.rada.gov.ua\/billInfo\/Bills\/Card\/42633\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">Draft Law No. 9662<\/span><\/a><span data-preserver-spaces=\"true\">\u00a0provisions, adopted by the Verkhovna Rada on February 23, 2024). The last stage lasted more than 2 years.<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">It should be noted that the amendments to the TCU apply to:<\/span><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\">patients who will participate in clinical trials and compassionate use programs, namely, they are to be\u00a0<\/span><em><span data-preserver-spaces=\"true\">&#8220;excluded from the total monthly (annual) taxable income of the taxpayer the cost of unregistered medications provided (transferred) free of charge in favor of patients participating in clinical trials, programs of expanded patient access to unregistered medicines and\/or programs of access of research subjects (patients) to the investigational medicinal product after the completion of clinical tri<\/span><\/em><span data-preserver-spaces=\"true\">als<\/span><\/li>\n<li><span data-preserver-spaces=\"true\">taxation at a preferential rate of &#8220;<\/span><em><span data-preserver-spaces=\"true\">7% of operations of importation of unregistered medicinal products into the customs territory of Ukraine within the framework of programs of expanded access of patients to unregistered medicinal products and\/or programs of access of research subjects (patients) to the investigational medicinal product after completion of a clinical trial &#8230;, as well as further free supply of medicinal products imported under this paragraph in the customs territory of Ukraine in favor of healthcare providers involved in the access programs<\/span><\/em><span data-preserver-spaces=\"true\">,<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">Thus, the\u00a0<\/span><a class=\"editor-rtfLink\" href=\"https:\/\/new.eba.com.ua\/en\/dostup-patsiyentam-do-likarskyh-zasobiv-zi-spivchuttya-nadano-zalyshyvsya-odyn-krok\/\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">project of the EBA Clinical Trials Subcommittee<\/span><\/a><span data-preserver-spaces=\"true\">\u00a0on the implementation of programs for expanded patient access to unregistered medicines and a program for access of research subjects (patients) to the investigational medicinal product after the completion of a clinical trial in Ukraine has reached its logical conclusion. This is an important step in the medical sector development and improvement of access to essential prescriptions for patients participating in such programs, who will receive innovative medicines free of charge. These changes will further encourage sponsors to develop such programs in Ukraine, positively impact the Ukrainian healthcare system, and help improve access to the necessary innovative treatment for the population. By joining forces, Ukraine will have a high-quality progressive legislative regulation of compassionate programs that meets international requirements.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Therefore, on behalf of the patients of Ukraine, we are grateful to the experts of EBA companies, MPs of Ukraine who supported the project, in particular Valerii Zub, the Verkhovna Rada Committee on National Health, Medical Care and Medical Insurance, Chairman of the Verkhovna Rada Committee on Finance, Taxation and Customs Policy Dmytro Hetmantsev, representatives of the Ministry of Health of Ukraine for understanding the importance of this initiative and helping to implement it, and representatives of the NGO &#8220;Patients of Ukraine&#8221; for supporting the project. We would also like to thank our Healthcare Committee partners, Arzinger and Dentons, for their cooperation.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">We hope the President of Ukraine will sign the law adopted by the Verkhovna Rada as soon as possible.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulation of the requirements for compassionate use programs is a crucial legislative change to enable such programs in Ukraine and improve access to innovative medicines for seriously ill patients. Amendments to the Tax Code of Ukraine (TCU) became the final chord in the compassionate use programs regulation. It is worth noting that this settlement was [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":537068,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[15564,15563,15574],"tags":[],"class_list":["post-788989","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lobbying-news-en","category-main-news-en","category-news-and-articles-from-association-en"],"_links":{"self":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/788989","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/users\/33544"}],"replies":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/comments?post=788989"}],"version-history":[{"count":0,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/posts\/788989\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media\/537068"}],"wp:attachment":[{"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/media?parent=788989"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/categories?post=788989"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.eba.com.ua\/en\/wp-json\/wp\/v2\/tags?post=788989"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}