{"id":395977,"date":"2022-02-16T11:15:54","date_gmt":"2022-02-16T09:15:54","guid":{"rendered":"https:\/\/eba.com.ua\/?p=395977"},"modified":"2025-02-06T13:01:07","modified_gmt":"2025-02-06T11:01:07","slug":"dostup-patsiyentam-do-likarskyh-zasobiv-zi-spivchuttya-nadano-zalyshyvsya-odyn-krok","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/dostup-patsiyentam-do-likarskyh-zasobiv-zi-spivchuttya-nadano-zalyshyvsya-odyn-krok\/","title":{"rendered":"[:ua]\u0414\u043e\u0441\u0442\u0443\u043f \u043f\u0430\u0446\u0456\u0454\u043d\u0442\u0430\u043c \u0434\u043e \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0437\u0456 \u0441\u043f\u0456\u0432\u0447\u0443\u0442\u0442\u044f \u043d\u0430\u0434\u0430\u043d\u043e, \u0437\u0430\u043b\u0438\u0448\u0438\u0432\u0441\u044f \u2013 \u043e\u0434\u0438\u043d \u043a\u0440\u043e\u043a[:en]One step left for the full launch of compassionate drug use in Ukraine[:]"},"content":{"rendered":"<p><\/p>\n<p>On February 15, the Law &#8220;On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of Compassionate Drug Use&#8221; was adopted. It was initiated by the EBA Clinical Trials Subcommittee which also took active participation in the development of the document.<\/p>\n<p><span data-preserver-spaces=\"true\">The law provides for settlement of legal relations and harmonization of national legislation with European Union law in the field of patients&#8217; access to innovative treatment and compassionate use of medicines in Ukraine.\u00a0<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Besides, the law defines the compassionate use programs within which patients can be provided free of charge with medicines unregistered in Ukraine for treatment. The procedure and use terms of such programs are also stipulated in the law. Thus, the law focuses on the following programs:<\/span><\/p>\n<ul>\n<li><span data-preserver-spaces=\"true\"> Program of extended access of patients to unregistered innovative medicines (a patient gains free access to an unregistered medicinal product that is approved for use or has passed at least the second phase of clinical trials in the United States, the European Economic Area, Australia, Canada, Japan, The United Kingdom or the Swiss Confederation, and for which safety and efficacy information is sufficient to assess the risk-benefit balance);<\/span><\/li>\n<li><span data-preserver-spaces=\"true\"> Program of access of trial subjects (patients) to the investigational medicinal product after completion of the clinical trial). A patient, who is the subject of clinical trials, gains free access to investigational drugs after completion of his\/her participation in the clinical trial.<\/span><\/li>\n<\/ul>\n<p><span data-preserver-spaces=\"true\">The law also establishes rules for importing and supplying unregistered medicines into the customs territory of Ukraine, prescribing, and using medicines intended for use in compassionate medicine programs, and defines the procedure for approving compassionate use programs by the Ministry of Health.\u00a0<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Relevant amendments have been made to the Laws of Ukraine &#8220;On Medicinal Products&#8221; and to the Fundamentals of the Legislation of Ukraine on Health Care.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Therefore, it is very important to inform patients, doctors, and leading manufacturers of innovative companies as soon as possible about the opportunities provided by the new law, which regulates the implementation of these programs in Ukraine. We hope that drug manufacturers, who for humanitarian reasons support patients and participate in such programs worldwide, will be able to initiate such programs in Ukraine.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">The importance of the adopted Law for patients of Ukraine is evidenced by the number of votes by which it was adopted &#8211; 297!<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">At the same time, business hopes that the Verkhovna Rada will shortly consider and adopt the second important draft Law \u21165737 on Amendments to the Tax Code of Ukraine to regulate the provision of compassionate medicines to patients, which is an integral part of such programs. The adoption of draft law\u00a0<a href=\"http:\/\/w1.c1.rada.gov.ua\/pls\/zweb2\/webproc4_1?pf3511=72438\">\u21165737<\/a>\u00a0will demonstrate the state&#8217;s understanding of the importance and support of compassionate use programs, as reducing the tax burden on imports of medicines provided to patients free of charge will be a strong signal for the development of such programs in Ukraine.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Draft law \u21165737 also plans to exempt patients from taxes for life-saving innovative medicines received free of charge as part of compassionate use programs.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">We truly thank Mr. Zub V.O., the People&#8217;s Deputy of Ukraine, as well as the representatives of the VRU Committee on Public Health, Medical Assistance, and Medical Insurance for supporting the initiative of the EBA Clinical Trials Subcommittee and Arzinger, EBA Health Care Committee legal advisor, for support in drafting the text of the draft law.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><em>Be the first to learn about the latest EBA news with our Telegram-channel <\/em><em>\u2013 <\/em><a href=\"https:\/\/bit.ly\/3g6lO9b\"><em>EBAUkraine<\/em><\/a><em>.<\/em><\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>On February 15, the Law &#8220;On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of Compassionate Drug Use&#8221; was adopted. It was initiated by the EBA Clinical Trials Subcommittee which also took active participation in the development of the document. The law provides for settlement of legal relations and harmonization of national legislation [&hellip;]<\/p>\n","protected":false},"author":23406,"featured_media":395988,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,13],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>One step left for the full launch of compassionate drug use in Ukraine - European Business Association<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eba.com.ua\/dostup-patsiyentam-do-likarskyh-zasobiv-zi-spivchuttya-nadano-zalyshyvsya-odyn-krok\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"One step left for the full launch of compassionate drug use in Ukraine - European Business Association\" \/>\n<meta property=\"og:description\" content=\"On February 15, the Law &#8220;On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of Compassionate Drug Use&#8221; was adopted. It was initiated by the EBA Clinical Trials Subcommittee which also took active participation in the development of the document. 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