{"id":376738,"date":"2021-11-22T18:22:07","date_gmt":"2021-11-22T16:22:07","guid":{"rendered":"https:\/\/eba.com.ua\/?p=376738"},"modified":"2021-11-23T00:10:47","modified_gmt":"2021-11-22T22:10:47","slug":"shhe-na-odyn-krok-ukrayina-stala-blyzhche-do-yes-u-regulyuvanni-klinichnyh-doslidzhen","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/shhe-na-odyn-krok-ukrayina-stala-blyzhche-do-yes-u-regulyuvanni-klinichnyh-doslidzhen\/","title":{"rendered":"[:ua]\u0429\u0435 \u043d\u0430 \u043e\u0434\u0438\u043d \u043a\u0440\u043e\u043a \u0423\u043a\u0440\u0430\u0457\u043d\u0430 \u0441\u0442\u0430\u043b\u0430 \u0431\u043b\u0438\u0436\u0447\u0435 \u0434\u043e \u0404\u0421 \u0443 \u0440\u0435\u0433\u0443\u043b\u044e\u0432\u0430\u043d\u043d\u0456 \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0438\u0445 \u0434\u043e\u0441\u043b\u0456\u0434\u0436\u0435\u043d\u044c[:en]Ukraine is one step closer to the EU in terms of clinical trials regulation[:]"},"content":{"rendered":"<p><\/p>\n<p><span data-preserver-spaces=\"true\">On November 18, the Verkhovna Rada of Ukraine adopted draft law\u00a0<\/span><a class=\"editor-rtfLink\" href=\"http:\/\/w1.c1.rada.gov.ua\/pls\/zweb2\/webproc4_1?pf3511=71544\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">\u21165315<\/span><\/a><span data-preserver-spaces=\"true\">\u00a0On Insurance&#8221; as a whole. In particular, it considers amendments to the regulation of insurance issues related to clinical trials, which were proposed by the EBA Clinical Trials Subcommittee experts. Thanks to these amendments, Ukraine will move to a fully European model of liability insurance in clinical trials.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">The law will amend the current Law of Ukraine \u201cOn Medicinal Products\u201d. Namely, these are amendments to Article 8 of the Law to clarify the provisions on the insurance contract that covers the liability of the clinical trial sponsor to third parties, as well as Article 2 of the Law to supplement the list of terms specified in the clinical trial insurance contract.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">The document helps to achieve the clear regulation of the insurance provision for clinical trials which has long been a problematic issue for the field of clinical trials in Ukraine and differed from the model operating in the EU.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Previously, Ukrainian legislation on insurance in clinical trials created possibilities for double interpretations, did not fully comply with international practice, did not cover all aspects of the sponsor&#8217;s and researchers&#8217; liability for possible harm to clinical trial subjects, and extended the periods for consideration of patient&#8217;s request to be included in a clinical trial that may be the only chance for him.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">This approach did not comply with the basic provisions of European law. As Directive 2001\/20 \/ EC stipulates the need to provide for &#8220;insurance or indemnification in order to cover the researcher&#8217;s or sponsor&#8217;s liability&#8221;, it is important to move from personal insurance in clinical trials to a liability insurance scheme.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Adoption of similar changes in Ukrainian legislation will improve the legal regulation of clinical trials and eliminate current problems that hinder patients&#8217; prompt access to innovative treatment in clinical trials and reduce the attractiveness of Ukraine in the eyes of sponsors of clinical trials.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">We truly thank Mr. Zub V.O., Member of Parliament for his support of the initiative of the EBA Clinical Trials Subcommittee.<\/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 November 18, the Verkhovna Rada of Ukraine adopted draft law\u00a0\u21165315\u00a0On Insurance&#8221; as a whole. In particular, it considers amendments to the regulation of insurance issues related to clinical trials, which were proposed by the EBA Clinical Trials Subcommittee experts. Thanks to these amendments, Ukraine will move to a fully European model of liability insurance [&hellip;]<\/p>\n","protected":false},"author":23406,"featured_media":376740,"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>Ukraine is one step closer to the EU in terms of clinical trials regulation - 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\/shhe-na-odyn-krok-ukrayina-stala-blyzhche-do-yes-u-regulyuvanni-klinichnyh-doslidzhen\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ukraine is one step closer to the EU in terms of clinical trials regulation - European Business Association\" \/>\n<meta property=\"og:description\" content=\"On November 18, the Verkhovna Rada of Ukraine adopted draft law\u00a0\u21165315\u00a0On Insurance&#8221; as a whole. In particular, it considers amendments to the regulation of insurance issues related to clinical trials, which were proposed by the EBA Clinical Trials Subcommittee experts. 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