{"id":30065,"date":"2024-07-05T05:34:05","date_gmt":"2024-07-05T05:34:05","guid":{"rendered":"https:\/\/www.theconservative.online\/stovky-leku-by-mohly-byt-stazeny-z-lekaren-v-eu"},"modified":"2024-07-05T05:35:24","modified_gmt":"2024-07-05T05:35:24","slug":"stovky-leku-by-mohly-byt-stazeny-z-lekaren-v-eu","status":"publish","type":"post","link":"https:\/\/www.theconservative.online\/cs\/stovky-leku-by-mohly-byt-stazeny-z-lekaren-v-eu","title":{"rendered":"Stovky l\u00e9k\u016f by mohly b\u00fdt sta\u017eeny z l\u00e9k\u00e1ren v EU"},"content":{"rendered":"<p>N\u011bkolik stovek l\u00e9k\u016f by mohlo b\u00fdt sta\u017eeno z evropsk\u00fdch l\u00e9k\u00e1ren, proto\u017ee se zjistilo, \u017ee nespl\u0148uj\u00ed pravidla pro jednotn\u00fd evropsk\u00fd trh. Jedn\u00e1 se o generick\u00e9 l\u00e9ky testovan\u00e9 v laborato\u0159i v Indii pro evropsk\u00e9 farmaceutick\u00e9 spole\u010dnosti, u nich\u017e existuje podez\u0159en\u00ed, \u017ee nejsou tak \u00fa\u010dinn\u00e9 jako referen\u010dn\u00ed l\u00e9ky. Odborn\u00edci z Evropsk\u00e9 agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (EMEA) dosp\u011bli po lo\u0148sk\u00e9m \u0161et\u0159en\u00ed k z\u00e1v\u011bru, \u017ee testy proveden\u00e9 v indick\u00e9 laborato\u0159i nebyly pr\u016fkazn\u00e9, proto\u017ee neprok\u00e1zaly, \u017ee tyto l\u00e9ky uvol\u0148uj\u00ed do t\u011bla stejn\u00e9 mno\u017estv\u00ed \u00fa\u010dinn\u00e9 l\u00e1tky jako inovativn\u00ed l\u00e9ky, kter\u00e9 napodobuj\u00ed. Obvykle se jedn\u00e1 o l\u00e9\u010dbu rakoviny, srde\u010dn\u00edch onemocn\u011bn\u00ed nebo cukrovky. Evropsk\u00e1 agentura pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky nyn\u00ed \u017e\u00e1d\u00e1 \u010dlensk\u00e9 zem\u011b o pozastaven\u00ed registrace.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<h3 style=\"text-align: center;\"><strong>Za posledn\u00edch 5 let bylo z rumunsk\u00e9ho trhu sta\u017eeno 3000 l\u00e9k\u016f.<\/strong><\/h3>\n<p>V Rumunsku je na seznamu l\u00e9k\u016f, kter\u00e9 by m\u011bly b\u00fdt sta\u017eeny z trhu, 45 p\u0159\u00edpravk\u016f. Pouze 7 z t\u011bchto 45 produkt\u016f lze zakoupit v rumunsk\u00fdch l\u00e9k\u00e1rn\u00e1ch. \u010cty\u0159i z t\u011bchto produkt\u016f jsou l\u00e9ky pou\u017e\u00edvan\u00e9 k l\u00e9\u010db\u011b rakoviny, co\u017e je onemocn\u011bn\u00ed, pro kter\u00e9 je na rumunsk\u00e9m trhu nedostatek l\u00e9k\u016f. A\u010dkoli doporu\u010den\u00ed EMEA zn\u00ed, \u017ee tyto l\u00e9\u010div\u00e9 p\u0159\u00edpravky by nem\u011bly b\u00fdt uv\u00e1d\u011bny na trh, dokud nebude k dispozici dostatek \u00fadaj\u016f potvrzuj\u00edc\u00edch, \u017ee maj\u00ed \u00fa\u010dinky uveden\u00e9 v p\u0159\u00edbalov\u00e9 informaci, mohou \u010dlensk\u00e9 st\u00e1ty rozhodnout o do\u010dasn\u00e9m ponech\u00e1n\u00ed n\u011bkter\u00fdch p\u0159\u00edpravk\u016f na trhu, aby se zabr\u00e1nilo jejich nedostatku. V Rumunsku bylo v posledn\u00edch p\u011bti letech sta\u017eeno z trhu 3000 l\u00e9k\u016f, v\u011bt\u0161inou generick\u00fdch. D\u016fvody byly p\u0159ev\u00e1\u017en\u011b ekonomick\u00e9 a v p\u0159\u00edli\u0161 mal\u00e9m po\u010dtu p\u0159\u00edpad\u016f to bylo kv\u016fli ne\u017e\u00e1douc\u00edm \u00fa\u010dink\u016fm pozorovan\u00fdm u pacient\u016f.<\/p><div class='related_content'><span>RELATED<\/span><ul><li><a href='https:\/\/www.theconservative.online\/cs\/moderni-krize-se-resi-chytlavymi-slogany'>Modern\u00ed krize se \u0159e\u0161\u00ed chytlav\u00fdmi slogany<\/li><\/a><li><a href='https:\/\/www.theconservative.online\/cs\/eu-celi-nedostatku-pracovniku-ve-zdravotnictvi-a-planuje-zefektivnit-uznavani-lekarskych-kvalifikaci'>EU \u010del\u00ed nedostatku pracovn\u00edk\u016f ve zdravotnictv\u00ed a pl\u00e1nuje zefektivnit uzn\u00e1v\u00e1n\u00ed l\u00e9ka\u0159sk\u00fdch kvalifikac\u00ed<\/li><\/a><li><a href='https:\/\/www.theconservative.online\/cs\/zasah-eu-proti-migraci-vyvolava-obavy-z-modelu-ice'>Z\u00e1sah EU proti migraci vyvol\u00e1v\u00e1 obavy z modelu &#8222;ICE&#8220;<\/li><\/a><\/ul><\/div>\n<h3 style=\"text-align: center;\"><strong>EK po\u017e\u00e1dala o pozastaven\u00ed registrace stovek l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f.<span class=\"Apple-converted-space\"> <\/span><\/strong><\/h3>\n<p>Evropsk\u00e1 komise ned\u00e1vno po\u017e\u00e1dala \u010dlensk\u00e9 st\u00e1ty, aby pozastavily registraci seznamu n\u011bkolika stovek generick\u00fdch l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f testovan\u00fdch indickou spole\u010dnost\u00ed Synapse Labs z d\u016fvodu nedostate\u010dn\u00fdch d\u016fkaz\u016f o spolehlivosti \u00fadaj\u016f z test\u016f. Doporu\u010den\u00ed bylo vyd\u00e1no na z\u00e1klad\u011b stanoviska agentury EMEA, kter\u00e1 koncem lo\u0148sk\u00e9ho roku zjistila, \u017ee v pr\u016fvodn\u00ed dokumentaci studi\u00ed a v informa\u010dn\u00edch syst\u00e9mech a postupech pro spr\u00e1vu \u00fadaj\u016f v nich obsa\u017een\u00fdch byly zji\u0161t\u011bny nesrovnalosti. Evropsk\u00e1 agentura pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky provedla kontrolu na z\u00e1klad\u011b \u017e\u00e1dosti \u0161pan\u011blsk\u00e9 agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky, kter\u00e1 ji\u017e d\u0159\u00edve provedla kontrolu laborato\u0159e v Indii.<\/p>\n<p>Po kontrol\u00e1ch v Indii vydala EMA v prosinci 2023 z\u00e1v\u011bry v\u011bdeck\u00e9ho posouzen\u00ed test\u016f proveden\u00fdch v laborato\u0159\u00edch Synapse Labs, ale pot\u00e9, co n\u011bkolik farmaceutick\u00fdch spole\u010dnost\u00ed zapojen\u00fdch do procesu v lednu 2024 p\u016fvodn\u00ed z\u00e1v\u011bry zpochybnilo, bylo provedeno nov\u00e9 p\u0159ezkoum\u00e1n\u00ed.<\/p>\n<p>V ofici\u00e1ln\u00edm sd\u011blen\u00ed, kter\u00e9 ned\u00e1vno vydala Evropsk\u00e1 komise, se uv\u00e1d\u00ed, \u017ee EMEA na z\u00e1klad\u011b v\u011bdeck\u00e9ho posouzen\u00ed zjistila, \u017ee testy spole\u010dnosti Synapse Labs na t\u011bchto generick\u00fdch l\u00e9\u010div\u00fdch p\u0159\u00edpravc\u00edch nespl\u0148uj\u00ed p\u0159\u00edsn\u00e9 po\u017eadavky EU na d\u016fkazy, kter\u00e9 by prok\u00e1zaly, \u017ee jsou rovnocenn\u00e9 referen\u010dn\u00edm l\u00e9\u010div\u00fdm p\u0159\u00edpravk\u016fm. Evropsk\u00e1 komise z\u00e1rove\u0148 ozn\u00e1mila, \u017ee po dohod\u011b s \u010dlensk\u00fdmi st\u00e1ty budou n\u00e1rodn\u00ed registrace pozastaveny, dokud v\u00fdrobci l\u00e9k\u016f nep\u0159edlo\u017e\u00ed platn\u00e9 a spolehliv\u00e9 \u00fadaje, kter\u00e9 prok\u00e1\u017e\u00ed rovnocennost generick\u00fdch a referen\u010dn\u00edch l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f. Do t\u00e9 doby v\u0161ak mohou \u010dlensk\u00e9 st\u00e1ty odlo\u017eit pozastaven\u00ed registrace a\u017e o dva roky u l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f, kter\u00e9 pova\u017euj\u00ed na vnitrost\u00e1tn\u00ed \u00farovni za kriticky d\u016fle\u017eit\u00e9, aby se p\u0159ede\u0161lo riziku nedostatku. Dvoulet\u00e1 lh\u016fta byla v podobn\u00fdch situac\u00edch ud\u011blena ji\u017e d\u0159\u00edve.<\/p>\n<blockquote><p>&#8222;EU zavedla p\u0159\u00edsn\u00fd a p\u0159\u00edsn\u00fd proces schvalov\u00e1n\u00ed l\u00e9\u010div a farmakovigilance, aby zajistila nejvy\u0161\u0161\u00ed standardy pro l\u00e9\u010diva v Evropsk\u00e9 unii,&#8220; uv\u00e1d\u00ed se v prohl\u00e1\u0161en\u00ed Evropsk\u00e9 komise.<\/p><\/blockquote>\n<p>Synapse Labs je nez\u00e1visl\u00e1 v\u00fdzkumn\u00e1 spole\u010dnost zalo\u017een\u00e1 v roce 2007 se s\u00eddlem v indick\u00e9m m\u011bst\u011b Pune, kter\u00e1 se specializuje na bioekvivalenci\/bio dostupnost a klinick\u00e9 studie, jako\u017e i na poradenstv\u00ed v oblasti farmaceutick\u00e9 regulace, a m\u00e1 klienty v Evrop\u011b i v USA.<\/p>\n<p>V Rumunsku by sta\u017een\u00ed n\u011bkter\u00fdch l\u00e9k\u016f testovan\u00fdch spole\u010dnost\u00ed Synapse Labs mohlo pacient\u016fm zp\u016fsobit probl\u00e9my. Jedn\u00e1 se o l\u00e9ky pou\u017e\u00edvan\u00e9 k l\u00e9\u010db\u011b rakoviny plic, za kter\u00e9 neexistuje n\u00e1hrada. Podle z\u00e1stupc\u016f N\u00e1rodn\u00ed agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky v Bukure\u0161ti je sice na seznamu problematick\u00fdch l\u00e9k\u016f 45 p\u0159\u00edpravk\u016f, ale pouze sedm z nich je skute\u010dn\u011b uv\u00e1d\u011bno na trh. Dva z nich lze zakoupit bez l\u00e9ka\u0159sk\u00e9ho p\u0159edpisu &#8211; protiz\u00e1n\u011btliv\u00fd a protipr\u016fjmov\u00fd. Z dal\u0161\u00edch p\u011bti jsou \u010dty\u0159i l\u00e9ky na l\u00e9\u010dbu rakoviny a jeden na mu\u017eskou erektiln\u00ed dysfunkci.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<blockquote><p>&#8222;Na \u00farovni n\u00e1rodn\u00edch ani evropsk\u00fdch \u00fa\u0159ad\u016f nejsou \u017e\u00e1dn\u00e9 zpr\u00e1vy o probl\u00e9mech, kter\u00e9 by u\u017e\u00edv\u00e1n\u00ed t\u011bchto l\u00e9k\u016f vyvolalo, nap\u0159\u00edklad o vedlej\u0161\u00edch \u00fa\u010dinc\u00edch. Probl\u00e9mem je, \u017ee nejsou tak \u00fa\u010dinn\u00e9,&#8220; \u0159ekl ProTV R\u0103zvan Prisada, \u0159editel N\u00e1rodn\u00ed agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky.<span class=\"Apple-converted-space\"> <\/span><\/p><\/blockquote>\n<h3 style=\"text-align: center;\"><strong>  Na rumunsk\u00e9m trhu chyb\u00ed 758 l\u00e9k\u016f<\/strong><\/h3>\n<p>A\u010dkoli by se podle ofici\u00e1ln\u00edch \u00fadaj\u016f mohlo zd\u00e1t, \u017ee Rumuni nakupuj\u00ed drogy draze, ve skute\u010dnosti tomu tak nen\u00ed. A\u010dkoli farmaceutick\u00fd trh v Rumunsku roste &#8211; v prvn\u00edm \u010dtvrtlet\u00ed leto\u0161n\u00edho roku dos\u00e1hla ro\u010dn\u00ed hodnota rumunsk\u00e9ho farmaceutick\u00e9ho trhu 7 miliard eur, co\u017e je o 13 % v\u00edce ne\u017e ve stejn\u00e9m obdob\u00ed lo\u0148sk\u00e9ho roku -, v rumunsk\u00fdch l\u00e9k\u00e1rn\u00e1ch jsou na n\u011bkter\u00e9 l\u00e9ky po\u0159adn\u00edky. Nejv\u011bt\u0161\u00ed probl\u00e9my jsou podle l\u00e9k\u00e1rn\u00edk\u016f s l\u00e9ky na l\u00e9\u010dbu rakoviny, srde\u010dn\u00edch onemocn\u011bn\u00ed a cukrovky, ale i dal\u0161\u00edch onemocn\u011bn\u00ed.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<p>Podle seznamu, kter\u00fd zve\u0159ejnila N\u00e1rodn\u00ed agentura pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky, chyb\u00ed Rumunsku v sou\u010dasn\u00e9 dob\u011b 758 l\u00e9k\u016f, od l\u00e9k\u016f na l\u00e9\u010dbu rakoviny a l\u00e9k\u016f po transplantaci a\u017e po vakc\u00edny pro d\u011bti. Podle odborn\u00edk\u016f jsou hlavn\u00ed d\u016fvody ekonomick\u00e9: levn\u00e9 l\u00e9ky nejsou n\u00e1kladov\u011b efektivn\u00ed a Rumuni si nemohou dovolit drah\u00e9 l\u00e9ky. Farmaceutick\u00e9 spole\u010dnosti ji\u017e do Rumunska nedod\u00e1vaj\u00ed levn\u00e9 l\u00e9ky, proto\u017ee by je musely prod\u00e1vat za ni\u017e\u0161\u00ed cenu, ne\u017e jsou v\u00fdrobn\u00ed n\u00e1klady. D\u00e1le je tu zp\u011btn\u00e1 da\u0148, kterou rumunsk\u00e9mu st\u00e1tu odv\u00e1d\u011bj\u00ed v\u00fdrobci l\u00e9k\u016f &#8211; 25 % ze zisku t\u011bch, kte\u0159\u00ed vyr\u00e1b\u011bj\u00ed inovativn\u00ed l\u00e9ky, a 15 % u v\u00fdrobc\u016f generik. Krom\u011b toho chyb\u00ed investice do m\u00edstn\u00edho syst\u00e9mu v\u00fdroby l\u00e9k\u016f a obecn\u011b chyb\u00ed suroviny, co\u017e ovliv\u0148uje cel\u00fd evropsk\u00fd farmaceutick\u00fd pr\u016fmysl, kter\u00fd je nucen dov\u00e1\u017eet \u00fa\u010dinn\u00e9 l\u00e1tky z \u010c\u00edny a Indie.<\/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>Generick\u00e9 l\u00e9ky jsou obvykle levn\u011bj\u0161\u00ed ne\u017e referen\u010dn\u00ed, ale m\u011bly by b\u00fdt stejn\u011b \u00fa\u010dinn\u00e9. P\u0159ibli\u017en\u011b 80 % l\u00e9k\u016f na trhu jsou &#8222;kopie&#8220; a pouze 20 % je inovativn\u00ed l\u00e9\u010dba. Pokud v\u0161ak jde o v\u00fdrobn\u00ed n\u00e1klady, je procento obr\u00e1cen\u00e9: 80 % je ur\u010deno na v\u00fdrobu nov\u00fdch, inovativn\u00edch l\u00e9k\u016f a l\u00e9\u010debn\u00fdch postup\u016f a pouze zbytek na generika.<span class=\"Apple-converted-space\">  <\/span>Tyto generick\u00e9 l\u00e9ky, kter\u00e9 jsou levn\u011bj\u0161\u00ed a dostupn\u011bj\u0161\u00ed pro v\u011bt\u0161inu pacient\u016f, jsou tak\u00e9 nejv\u00edce ohro\u017eeny politikou nejni\u017e\u0161\u00ed ceny a dan\u00ed z navr\u00e1cen\u00ed, p\u0159ipou\u0161t\u011bj\u00ed n\u011bkte\u0159\u00ed v\u00fdrobci l\u00e9\u010div.<\/p>\n<p>V sou\u010dasn\u00e9 dob\u011b je v Rumunsku k dispozici n\u011bco m\u00e1lo p\u0159es 2000 generick\u00fdch l\u00e9k\u016f, a\u010dkoli p\u0159ed p\u011bti lety byl jejich po\u010det t\u00e9m\u011b\u0159 dvojn\u00e1sobn\u00fd. Ve stejn\u00e9m obdob\u00ed bylo z trhu sta\u017eeno 3000 l\u00e9k\u016f, z nich\u017e v\u00edce ne\u017e 80 % bylo generick\u00fdch a pouze 20 % inovativn\u00edch. Rumunsk\u00e9 org\u00e1ny se sna\u017e\u00ed podpo\u0159it v\u00fdrobu m\u00edstn\u00edch l\u00e9k\u016f t\u00edm, \u017ee schv\u00e1lily st\u00e1tn\u00ed podporu ve v\u00fd\u0161i v\u00edce ne\u017e 500 milion\u016f eur pro rumunsk\u00e9 tov\u00e1rny. Ve skute\u010dnosti je v Rumunsku pouze 52 v\u00fdrobc\u016f l\u00e9\u010div a \u00fa\u010dinn\u00fdch farmaceutick\u00fdch l\u00e1tek. Nap\u0159\u00edklad v posledn\u00edch dvou letech se v\u0161ak do tohoto odv\u011btv\u00ed pr\u016fmyslu investovalo pouze 250 milion\u016f EUR, co\u017e je hluboko pod potenci\u00e1lem trhu. Pokud jde o inovace, je na tom Rumunsko je\u0161t\u011b h\u016f\u0159e, proto\u017ee v\u00fdvoj l\u00e9ku trv\u00e1 12 a\u017e 15 let a n\u00e1klady na jeden l\u00e9k dosahuj\u00ed 2 miliard eur, co\u017e si rumunsk\u00fd st\u00e1t nem\u016f\u017ee dovolit.<\/p>\n<\/p>","protected":false},"excerpt":{"rendered":"<p>N\u011bkolik stovek l\u00e9k\u016f by mohlo b\u00fdt sta\u017eeno z evropsk\u00fdch l\u00e9k\u00e1ren, proto\u017ee se zjistilo, \u017ee nespl\u0148uj\u00ed pravidla pro jednotn\u00fd evropsk\u00fd trh. Jedn\u00e1 se o generick\u00e9 l\u00e9ky testovan\u00e9 v laborato\u0159i v Indii pro evropsk\u00e9 farmaceutick\u00e9 spole\u010dnosti, u nich\u017e existuje podez\u0159en\u00ed, \u017ee nejsou tak \u00fa\u010dinn\u00e9 jako referen\u010dn\u00ed l\u00e9ky. Odborn\u00edci z Evropsk\u00e9 agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (EMEA) dosp\u011bli po [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":30037,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[199],"tags":[283,1588,1586,1587],"editorial-positions":[42],"regions":[328,339,344,356,364],"types":[415],"class_list":["post-30065","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-zdravi","tag-european-commission","tag-european-medicines-agency","tag-pharmaceutical-companies","tag-synapse-labs","editorial-positions-focus","regions-central-europe-cs","regions-eastern-europe-cs","regions-northern-europe-cs","regions-southern-europe-cs","regions-western-europe-cs","types-news-cs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Stovky l\u00e9k\u016f by mohly b\u00fdt sta\u017eeny z l\u00e9k\u00e1ren v EU - 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\/cs\/stovky-leku-by-mohly-byt-stazeny-z-lekaren-v-eu\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Stovky l\u00e9k\u016f by mohly b\u00fdt sta\u017eeny z l\u00e9k\u00e1ren v EU - The Conservative\" \/>\n<meta property=\"og:description\" content=\"N\u011bkolik stovek l\u00e9k\u016f by mohlo b\u00fdt sta\u017eeno z evropsk\u00fdch l\u00e9k\u00e1ren, proto\u017ee se zjistilo, \u017ee nespl\u0148uj\u00ed pravidla pro jednotn\u00fd evropsk\u00fd trh. 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