{"id":393386,"date":"2022-02-04T15:04:21","date_gmt":"2022-02-04T13:04:21","guid":{"rendered":"https:\/\/eba.com.ua\/?p=393386"},"modified":"2022-02-04T16:26:33","modified_gmt":"2022-02-04T14:26:33","slug":"zakonoproyekt-shhodo-vlasnyka-reyestratsiyi-na-liky-biznes-zaklykaye-do-poslidovnosti","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/zakonoproyekt-shhodo-vlasnyka-reyestratsiyi-na-liky-biznes-zaklykaye-do-poslidovnosti\/","title":{"rendered":"[:ua]\u0417\u0430\u043a\u043e\u043d\u043e\u043f\u0440\u043e\u0454\u043a\u0442 \u0449\u043e\u0434\u043e \u0432\u043b\u0430\u0441\u043d\u0438\u043a\u0430 \u0440\u0435\u0454\u0441\u0442\u0440\u0430\u0446\u0456\u0457 \u043d\u0430 \u043b\u0456\u043a\u0438 \u2013 \u0431\u0456\u0437\u043d\u0435\u0441 \u0437\u0430\u043a\u043b\u0438\u043a\u0430\u0454 \u0434\u043e \u043f\u043e\u0441\u043b\u0456\u0434\u043e\u0432\u043d\u043e\u0441\u0442\u0456[:en]Business calls for consistency regarding the draft law on drug registration ownership[:]"},"content":{"rendered":"<p><\/p>\n<p><span data-preserver-spaces=\"true\">The European Business Association appealed to the Verkhovna Rada Committee on Public Health, Medical Assistance, and Medical Insurance to recommend the rejection of\u00a0<\/span><a class=\"editor-rtfLink\" href=\"http:\/\/w1.c1.rada.gov.ua\/pls\/zweb2\/webproc4_1?id=&amp;pf3511=73609\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">draft Law \u21166535<\/span><\/a><span data-preserver-spaces=\"true\">\u00a0on the applicant, the holder of medicine registration certificates.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">On January 20, 2022, the Government approved draft law \u21166535, developed by the Ministry of Health of Ukraine, which proposes to impose significant restrictions on persons who may be holders of medicine registration certificates in Ukraine. The EBA has already expressed\u00a0<\/span><a class=\"editor-rtfLink\" href=\"https:\/\/eba.com.ua\/en\/informatsiya-pro-nevykonannya-vlasnykamy-reyestratsijnyh-posvidchen-na-likarski-zasoby-svoyih-obov-yazkiv-nedostovirna\/\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">its position<\/span><\/a><span data-preserver-spaces=\"true\">\u00a0on this draft law, which has been initiated several times in recent years by the Ministry of Health of Ukraine.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Business does not support draft Law \u21166535, as its adoption may lead to worsening conditions in the pharmaceutical industry, rising prices for medicines, and some categories of medicines may disappear from the market in Ukraine.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Unfortunately, draft Law \u21166535 does not fully comply with the provisions of EU legislation and does not comply with the provisions and proposals already prepared for consideration for the second reading in the comprehensive draft\u00a0<\/span><a class=\"editor-rtfLink\" href=\"http:\/\/w1.c1.rada.gov.ua\/pls\/zweb2\/webproc4_1?pf3511=72012\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">Law on Medicinal Products (\u21165547)<\/span><\/a><span data-preserver-spaces=\"true\">\u00a0of 21 May 2021. Draft Law \u21165547 provides additional mechanisms for access of Ukrainian patients to medicines intended for the treatment of rare (orphan) diseases, HIV, hemophilia, cancer, etc. It would be possible to achieve better access of patients to medicines in these areas only by providing the opportunity to act as holders of medicine registration certificates in Ukraine not only to residents of Ukraine but also to EU member states and SRA countries.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">At the same time, the draft Law \u21166535 proposes, on the contrary, to limit the possibility of being the holder of medicine registration certificates exclusively to residents of Ukraine.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Besides, businesses have repeatedly reported the lack of facts conveying that the holders of medicine registration certificates do not fulfill their obligations under the current legislation of Ukraine, which could be the basis for this legislative initiative. There is also no information on inadequate business communication on quality control of medicines in cooperation with the State Medical Service, or on post-registration supervision or pharmacovigilance in cooperation with the State Expert Center of the Ministry of Health of Ukraine, etc.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">The current legislation of Ukraine contains a full list of current conditions, rules, and requirements for ensuring the safety, quality, and efficacy of medicines, including the availability of pharmacovigilance and compliance with GMP requirements, and provides effective mechanisms for control, prevention, and prosecution in case detection of violations.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">Therefore, the European Business Association considers Draft Law \u21166535 as one that will not have positive consequences for ensuring the quality, safety, and efficacy of medicines registered in Ukraine. Instead, Draft Law \u21166535 may lead to a significant deterioration in the conditions of doing pharmaceutical business, increase prices for medicines and reduce their availability to patients in Ukraine. In the context of the global pandemic, the instability of drug supply chains in Ukraine, the pharmaceutical industry should be stimulated and supported and the best international practices of access to medicines should be continued.<\/span><\/p>\n<p><span data-preserver-spaces=\"true\">At present, we see the draft law as inconsistent and one that would increase the over-regulation of the operating activities of international manufacturers in the absence of grounds. The professional EBA business community prefers to support healthcare initiatives that can be described as patient-oriented and that consider the specifics of global pharmaceutical manufacturers. The EBA is concerned that the proposed approach does not, in fact, address the issue of \u201cavailability\u201d of medicines for patients, given that such initiatives are currently in place in Ukraine (such as managed entry contracts) or are being developed (compassionate drug use). Therefore, we believe that reconsideration of the issue envisaged by Draft Law \u21166535 would be inexpedient also given the preliminary comprehensive discussion and coordination in the framework of the preparation of Draft Law \u21165547 for the second reading.<\/span><\/p>\n<p><strong><span data-preserver-spaces=\"true\">For reference:<\/span><\/strong><span data-preserver-spaces=\"true\">\u00a0the List of Stringent Regulatory Authorities (SRA) include countries, which, according to the World Health Organization (WHO), apply strict standards of quality, safety, and efficacy in the regulatory control of drugs and vaccines to obtain permits for their registration and sales. Currently, SRA countries include, namely, Australia, the United Kingdom, the United States, EU member states, and Japan. Full list\u00a0<\/span><a class=\"editor-rtfLink\" href=\"https:\/\/www.who.int\/initiatives\/who-listed-authority-reg-authorities\/SRAs\" target=\"_blank\" rel=\"noopener\"><span data-preserver-spaces=\"true\">at the link<\/span><\/a><span data-preserver-spaces=\"true\">.<\/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>The European Business Association appealed to the Verkhovna Rada Committee on Public Health, Medical Assistance, and Medical Insurance to recommend the rejection of\u00a0draft Law \u21166535\u00a0on the applicant, the holder of medicine registration certificates. On January 20, 2022, the Government approved draft law \u21166535, developed by the Ministry of Health of Ukraine, which proposes to impose [&hellip;]<\/p>\n","protected":false},"author":23406,"featured_media":393390,"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>Business calls for consistency regarding the draft law on drug registration ownership - 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\/zakonoproyekt-shhodo-vlasnyka-reyestratsiyi-na-liky-biznes-zaklykaye-do-poslidovnosti\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Business calls for consistency regarding the draft law on drug registration ownership - European Business Association\" \/>\n<meta property=\"og:description\" content=\"The European Business Association appealed to the Verkhovna Rada Committee on Public Health, Medical Assistance, and Medical Insurance to recommend the rejection of\u00a0draft Law \u21166535\u00a0on the applicant, the holder of medicine registration certificates. 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