{"id":30293,"date":"2024-07-05T05:34:05","date_gmt":"2024-07-05T05:34:05","guid":{"rendered":"https:\/\/www.theconservative.online\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue"},"modified":"2024-07-05T05:34:05","modified_gmt":"2024-07-05T05:34:05","slug":"sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue","status":"publish","type":"post","link":"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue","title":{"rendered":"Sute de medicamente ar putea fi retrase din farmaciile din UE"},"content":{"rendered":"<p>Mai multe sute de medicamente ar putea fi retrase din farmaciile din Europa, deoarece s-a constatat c\u0103 nu respect\u0103 normele care reglementeaz\u0103 pia\u021ba unic\u0103 european\u0103. Medicamentele generice sunt testate \u00eentr-un laborator din India pentru companii farmaceutice europene \u0219i sunt suspectate c\u0103 nu sunt la fel de eficiente ca medicamentele de referin\u021b\u0103. Mai exact, \u00een urma investiga\u021biilor de anul trecut, exper\u021bii Agen\u021biei Europene pentru Medicamente (EMEA) au concluzionat c\u0103 testele efectuate \u00een laboratorul indian nu au fost concludente, deoarece nu au dovedit c\u0103 aceste medicamente elibereaz\u0103 \u00een organism aceea\u0219i cantitate de substan\u021b\u0103 activ\u0103 ca medicamentele inovatoare pe care le imit\u0103. Acestea sunt, \u00een general, tratamente pentru cancer, boli de inim\u0103 sau diabet. Agen\u021bia European\u0103 pentru Medicamente solicit\u0103 acum \u021b\u0103rilor membre s\u0103 suspende autoriza\u021biile lor de introducere pe pia\u021b\u0103.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<h3 style=\"text-align: center;\"><strong>\u00cen ultimii 5 ani, 3000 de medicamente au fost retrase de pe pia\u021ba rom\u00e2neasc\u0103<\/strong><\/h3>\n<p>\u00cen Rom\u00e2nia, lista medicamentelor care ar trebui retrase de pe pia\u021b\u0103 include 45 de produse. Doar 7 din aceste 45 de produse pot fi cump\u0103rate din farmaciile rom\u00e2ne\u0219ti. Patru dintre aceste produse sunt medicamente utilizate pentru tratamentul cancerului, o boal\u0103 pentru care exist\u0103 un deficit de medicamente pe pia\u021ba rom\u00e2neasc\u0103. De\u0219i recomandarea EMEA este ca aceste medicamente s\u0103 nu fie comercializate p\u00e2n\u0103 c\u00e2nd nu exist\u0103 suficiente date care s\u0103 confirme c\u0103 acestea produc efectele men\u021bionate \u00een prospect, statele membre pot decide s\u0103 men\u021bin\u0103 temporar anumite produse pe pia\u021b\u0103 pentru a evita o penurie. \u00cen Rom\u00e2nia, 3000 de medicamente au fost retrase de pe pia\u021b\u0103 \u00een ultimii 5 ani, majoritatea generice. Motivele au fost \u00een principal economice \u0219i, \u00een prea pu\u021bine cazuri, au fost cauzate de efectele adverse observate la pacien\u021bi.<\/p><div class='related_content'><span>RELATED<\/span><ul><li><a href='https:\/\/www.theconservative.online\/ro\/strategia-europeana-a-chery-exploatarea-aliantelor-pentru-extinderea-amprentei-de-productie'>Strategia european\u0103 a Chery: Exploatarea alian\u021belor pentru extinderea amprentei de produc\u021bie<\/li><\/a><li><a href='https:\/\/www.theconservative.online\/ro\/ue-lanseaza-un-sistem-complet-de-intrare-iesire-o-revizuire-digitala-a-controalelor-la-frontiera'>UE lanseaz\u0103 un sistem complet de intrare\/ie\u0219ire: O revizuire digital\u0103 a controalelor la frontier\u0103<\/li><\/a><li><a href='https:\/\/www.theconservative.online\/ro\/italia-a-depasit-obiectivul-ue-privind-abandonul-scolar-cu-cinci-ani-mai-devreme'>Italia a dep\u0103\u0219it obiectivul UE privind abandonul \u0219colar cu cinci ani mai devreme<\/li><\/a><\/ul><\/div>\n<h3 style=\"text-align: center;\"><strong>CE a solicitat suspendarea autoriza\u021biei de introducere pe pia\u021b\u0103 pentru sute de medicamente<span class=\"Apple-converted-space\"> <\/span><\/strong><\/h3>\n<p>Comisia European\u0103 a solicitat recent statelor membre s\u0103 suspende autoriza\u021bia de introducere pe pia\u021b\u0103 pentru o list\u0103 de c\u00e2teva sute de medicamente generice testate de compania indian\u0103 Synapse Labs din cauza dovezilor insuficiente privind fiabilitatea datelor testelor. Recomandarea a fost f\u0103cut\u0103 pe baza unui aviz al EMEA, care a stabilit la sf\u00e2r\u0219itul anului trecut c\u0103 au existat nereguli \u00een documenta\u021bia care \u00eenso\u021be\u0219te studiile \u0219i \u00een sistemele \u0219i procedurile IT de gestionare a datelor din acestea. Revizuirea Agen\u021biei Europene pentru Medicamente a urmat unei solicit\u0103ri din partea agen\u021biei pentru medicamente din Spania, care inspectase anterior laboratorul din India.<\/p>\n<p>\u00cen urma inspec\u021biilor din India, EMA a publicat concluziile evalu\u0103rii sale \u0219tiin\u021bifice a testelor efectuate la Synapse Labs \u00een decembrie 2023, dar ulterior, \u00een ianuarie 2024, a fost efectuat\u0103 o nou\u0103 revizuire dup\u0103 ce mai multe companii farmaceutice implicate \u00een proces au contestat concluziile ini\u021biale.<\/p>\n<p>\u00cen comunicarea oficial\u0103 emis\u0103 recent de Comisia European\u0103, se afirm\u0103 c\u0103 EMEA a stabilit, \u00een urma unei evalu\u0103ri \u0219tiin\u021bifice, c\u0103 testele Synapse Labs privind aceste medicamente generice nu au \u00eendeplinit cerin\u021bele stricte ale UE \u00een materie de dovezi pentru a demonstra c\u0103 acestea sunt echivalente cu medicamentele de referin\u021b\u0103. \u00cen acela\u0219i timp, Comisia European\u0103 a anun\u021bat c\u0103, \u00een acord cu statele membre, autoriza\u021biile na\u021bionale de introducere pe pia\u021b\u0103 vor fi suspendate p\u00e2n\u0103 c\u00e2nd produc\u0103torii de medicamente pot furniza date valide \u0219i fiabile pentru a demonstra echivalen\u021ba medicamentelor generice \u0219i de referin\u021b\u0103. Cu toate acestea, p\u00e2n\u0103 atunci, statele membre pot am\u00e2na suspendarea autoriza\u021biilor de introducere pe pia\u021b\u0103 pentru o perioad\u0103 de p\u00e2n\u0103 la 2 ani pentru medicamentele pe care le consider\u0103 a fi de importan\u021b\u0103 critic\u0103 la nivel na\u021bional, pentru a evita orice risc de penurie. Perioada de 2 ani a mai fost acordat\u0103 \u00een situa\u021bii similare.<\/p>\n<blockquote><p>&#8222;UE a instituit un proces strict \u0219i riguros de aprobare a medicamentelor \u0219i de farmacovigilen\u021b\u0103 pentru a asigura cele mai \u00eenalte standarde pentru medicamente \u00een Uniunea European\u0103&#8221;, se arat\u0103 \u00een declara\u021bia Comisiei Europene.<\/p><\/blockquote>\n<p>Synapse Labs este o companie de cercetare independent\u0103 \u00eenfiin\u021bat\u0103 \u00een 2007, cu sediul \u00een Pune, India, specializat\u0103 \u00een bioechivalen\u021b\u0103\/biodisponibilitate \u0219i studii clinice, precum \u0219i \u00een consultan\u021b\u0103 \u00een domeniul reglement\u0103rii farmaceutice, cu clien\u021bi at\u00e2t \u00een Europa, c\u00e2t \u0219i \u00een SUA.<\/p>\n<p>\u00cen Rom\u00e2nia, retragerea unora dintre medicamentele testate de Synapse Labs ar putea crea probleme pentru pacien\u021bi. Acestea sunt medicamente utilizate pentru tratarea cancerului pulmonar, pentru care nu exist\u0103 \u00eenlocuitori. Potrivit reprezentan\u021bilor Agen\u021biei Na\u021bionale a Medicamentului de la Bucure\u0219ti, de\u0219i exist\u0103 45 de produse pe lista medicamentelor problematice, doar \u0219apte dintre acestea sunt comercializate efectiv. Dintre acestea, dou\u0103 pot fi cump\u0103rate f\u0103r\u0103 prescrip\u021bie medical\u0103 &#8211; un antiinflamator \u0219i un antidiareic. Dintre celelalte cinci, patru sunt medicamente pentru tratarea cancerului \u0219i unul pentru disfunc\u021bia erectil\u0103 masculin\u0103.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<blockquote><p>&#8222;Nu exist\u0103 rapoarte la nivelul autorit\u0103\u021bilor na\u021bionale sau europene cu privire la problemele pe care le-a ridicat utilizarea acestor medicamente, cum ar fi efectele secundare. Problema este c\u0103 nu sunt la fel de eficiente&#8221;, a declarat R\u0103zvan Prisada, directorul Agen\u021biei Na\u021bionale a Medicamentului, la ProTV.<span class=\"Apple-converted-space\"> <\/span><\/p><\/blockquote>\n<h3 style=\"text-align: center;\"><strong>  758 de medicamente lipsesc de pe pia\u021ba rom\u00e2neasc\u0103<\/strong><\/h3>\n<p>De\u0219i cifrele oficiale ar putea face s\u0103 par\u0103 c\u0103 rom\u00e2nii cump\u0103r\u0103 droguri la suprapre\u021b, \u00een realitate nu este a\u0219a. De\u0219i pia\u021ba farmaceutic\u0103 este \u00een cre\u0219tere \u00een Rom\u00e2nia &#8211; \u00een primul trimestru al acestui an, valoarea anual\u0103 a pie\u021bei farmaceutice rom\u00e2ne\u0219ti a ajuns la 7 miliarde de euro, cu 13% mai mult dec\u00e2t \u00een aceea\u0219i perioad\u0103 a anului trecut &#8211; farmaciile rom\u00e2ne\u0219ti au liste de a\u0219teptare pentru unele medicamente. Farmaci\u0219tii spun c\u0103 cele mai mari probleme sunt legate de medicamentele pentru tratamentul cancerului, al bolilor de inim\u0103 \u0219i al diabetului, dar \u0219i pentru alte afec\u021biuni.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<p>\u00cen prezent, Rom\u00e2nia duce lips\u0103 de 758 de medicamente, de la cele pentru tratarea cancerului \u0219i post-transplant p\u00e2n\u0103 la vaccinurile pentru copii, potrivit unei liste publicate de Agen\u021bia Na\u021bional\u0103 a Medicamentului. Potrivit exper\u021bilor, principalele motive sunt de natur\u0103 economic\u0103: medicamentele ieftine nu sunt rentabile, iar rom\u00e2nii nu \u0219i le permit pe cele scumpe. Companiile farmaceutice nu mai aduc medicamente ieftine \u00een Rom\u00e2nia deoarece ar trebui s\u0103 le v\u00e2nd\u0103 la un pre\u021b mai mic dec\u00e2t costul de produc\u021bie. Mai este \u0219i taxa clawback pl\u0103tit\u0103 statului rom\u00e2n de produc\u0103torii de medicamente &#8211; 25% din profiturile celor care produc medicamente inovatoare \u0219i 15% pentru produc\u0103torii de medicamente generice. \u00cen plus, exist\u0103 o lips\u0103 de investi\u021bii \u00een sistemul local de produc\u021bie a medicamentelor \u0219i, \u00een general, o lips\u0103 de materii prime, care afecteaz\u0103 \u00eentreaga industrie farmaceutic\u0103 european\u0103, care este nevoit\u0103 s\u0103 importe substan\u021be active din China \u0219i India.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-30044 aligncenter\" src=\"https:\/\/www.theconservative.online\/wp-content\/uploads\/2024\/07\/medical-pils-1-scaled.jpg\" alt=\"\" width=\"2560\" height=\"1707\"><\/p>\n<p>Medicamentele generice sunt \u00een general mai ieftine dec\u00e2t cele de referin\u021b\u0103, dar ar trebui s\u0103 fie la fel de eficiente. Aproximativ 80% din medicamentele de pe pia\u021b\u0103 sunt &#8222;copii&#8221; \u0219i doar 20% sunt tratamente inovatoare. Cu toate acestea, atunci c\u00e2nd vine vorba de costurile de produc\u021bie, procentul este invers: 80% este alocat produc\u021biei de medicamente \u0219i tratamente noi, inovatoare, iar restul doar medicamentelor generice.<span class=\"Apple-converted-space\">  <\/span>Aceste medicamente generice, care sunt mai ieftine \u0219i mai accesibile pentru marea majoritate a pacien\u021bilor, sunt, de asemenea, cele mai amenin\u021bate de politica celor mai mici pre\u021buri \u0219i de taxa clawback, recunosc unii produc\u0103tori farmaceutici.<\/p>\n<p>\u00cen prezent, \u00een Rom\u00e2nia exist\u0103 pu\u021bin peste 2000 de medicamente generice, de\u0219i \u00een urm\u0103 cu cinci ani num\u0103rul acestora era aproape dublu. \u00cen aceea\u0219i perioad\u0103, 3 000 de medicamente au fost retrase de pe pia\u021b\u0103, dintre care mai mult de 80 % sunt generice \u0219i doar 20 % inovatoare. Autorit\u0103\u021bile rom\u00e2ne \u00eencearc\u0103 s\u0103 \u00eencurajeze produc\u021bia de medicamente locale prin aprobarea unui ajutor de stat de peste 500 de milioane de euro pentru fabricile rom\u00e2ne\u0219ti. De fapt, \u00een Rom\u00e2nia exist\u0103 doar 52 de produc\u0103tori de medicamente \u0219i substan\u021be farmaceutice active. Cu toate acestea, \u00een ultimii doi ani, de exemplu, suma investit\u0103 \u00een acest sector al industriei a fost de numai 250 de milioane EUR, ceea ce este cu mult sub poten\u021bialul pie\u021bei. \u00cen ceea ce prive\u0219te inovarea, Rom\u00e2nia st\u0103 \u0219i mai prost, \u0219i asta pentru c\u0103 dezvoltarea unui medicament dureaz\u0103 \u00eentre 12 \u0219i 15 ani, la un cost de 2 miliarde de euro pe medicament, pe care statul rom\u00e2n nu \u0219i-l poate permite.<\/p>\n<\/p>","protected":false},"excerpt":{"rendered":"<p>Mai multe sute de medicamente ar putea fi retrase din farmaciile din Europa, deoarece s-a constatat c\u0103 nu respect\u0103 normele care reglementeaz\u0103 pia\u021ba unic\u0103 european\u0103. Medicamentele generice sunt testate \u00eentr-un laborator din India pentru companii farmaceutice europene \u0219i sunt suspectate c\u0103 nu sunt la fel de eficiente ca medicamentele de referin\u021b\u0103. Mai exact, \u00een urma [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":30041,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[200],"tags":[283,1588,1586,1587],"editorial-positions":[42],"regions":[329,338,346,355,365],"types":[417],"class_list":["post-30293","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sanatate","tag-european-commission","tag-european-medicines-agency","tag-pharmaceutical-companies","tag-synapse-labs","editorial-positions-focus","regions-central-europe-ro","regions-eastern-europe-ro","regions-northern-europe-ro","regions-southern-europe-ro","regions-western-europe-ro","types-news-ro"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Sute de medicamente ar putea fi retrase din farmaciile din UE - The Conservative<\/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:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sute de medicamente ar putea fi retrase din farmaciile din UE - The Conservative\" \/>\n<meta property=\"og:description\" content=\"Mai multe sute de medicamente ar putea fi retrase din farmaciile din Europa, deoarece s-a constatat c\u0103 nu respect\u0103 normele care reglementeaz\u0103 pia\u021ba unic\u0103 european\u0103. Medicamentele generice sunt testate \u00eentr-un laborator din India pentru companii farmaceutice europene \u0219i sunt suspectate c\u0103 nu sunt la fel de eficiente ca medicamentele de referin\u021b\u0103. Mai exact, \u00een urma [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue\" \/>\n<meta property=\"og:site_name\" content=\"The Conservative\" \/>\n<meta property=\"article:author\" content=\"https:\/\/www.facebook.com\/eugen.olariu.1\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-05T05:34:05+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.theconservative.online\/wp-content\/uploads\/2024\/07\/medical-pils-1-scaled.jpg\" \/>\n<meta name=\"author\" content=\"Eugen Olariu\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Scris de\" \/>\n\t<meta name=\"twitter:data1\" content=\"Eugen Olariu\" \/>\n\t<meta name=\"twitter:label2\" content=\"Timp estimat pentru citire\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue\"},\"author\":{\"name\":\"Eugen Olariu\",\"@id\":\"https:\/\/www.theconservative.online\/ro#\/schema\/person\/6c786247c8de5b7ab0ee5cdaf2c1c0fd\"},\"headline\":\"Sute de medicamente ar putea fi retrase din farmaciile din UE\",\"datePublished\":\"2024-07-05T05:34:05+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue\"},\"wordCount\":1398,\"image\":{\"@id\":\"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.theconservative.online\/wp-content\/uploads\/2024\/07\/medical-pils-2-scaled.jpg\",\"keywords\":[\"European Commission\",\"European Medicines Agency\",\"pharmaceutical companies\",\"Synapse Labs\"],\"articleSection\":[\"S\u0103n\u0103tate\"],\"inLanguage\":\"ro-RO\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue\",\"url\":\"https:\/\/www.theconservative.online\/ro\/sute-de-medicamente-ar-putea-fi-retrase-din-farmaciile-din-ue\",\"name\":\"Sute de medicamente ar putea fi retrase din farmaciile din UE - 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Medicamentele generice sunt testate \u00eentr-un laborator din India pentru companii farmaceutice europene \u0219i sunt suspectate c\u0103 nu sunt la fel de eficiente ca medicamentele de referin\u021b\u0103. 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