{"id":135879,"date":"2026-07-02T05:18:08","date_gmt":"2026-07-02T05:18:08","guid":{"rendered":"https:\/\/www.europesays.com\/cz\/135879\/"},"modified":"2026-07-02T05:18:08","modified_gmt":"2026-07-02T05:18:08","slug":"evropa-prohrava-boj-o-nove-leky-irsko-ma-pul-roku-na-to-aby-to-zmenilo","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/cz\/135879\/","title":{"rendered":"Evropa prohr\u00e1v\u00e1 boj o nov\u00e9 l\u00e9ky. Irsko m\u00e1 p\u016fl roku na to, aby to zm\u011bnilo"},"content":{"rendered":"<p>Pod\u00edl Evropy na glob\u00e1ln\u00edch klinick\u00fdch studi\u00edch se za pouh\u00e9 desetilet\u00ed propadl na polovinu, zat\u00edmco \u010c\u00edna raketov\u011b roste. Irsko, kter\u00e9 ve st\u0159edu p\u0159ebralo p\u0159edsednictv\u00ed v Rad\u011b EU, s\u00e1z\u00ed na to, \u017ee rychlej\u0161\u00ed schvalov\u00e1n\u00ed l\u00e9k\u016f, reformy v biotechnologi\u00edch a investice do zdravotnictv\u00ed vr\u00e1t\u00ed Evrop\u011b konkurenceschopnost. Nav\u00edc to rozhodne, jak rychle se pacienti dostanou k nov\u00fdm l\u00e9k\u016fm.<\/p>\n<p>Irsko p\u0159ebralo rotuj\u00edc\u00ed p\u0159edsednictv\u00ed 1. \u010dervence od Kypru a na p\u0159\u00ed\u0161t\u00edch \u0161est m\u011bs\u00edc\u016f ur\u010d\u00ed unijn\u00ed agendu. Jeho strategie je jednoduch\u00e1: investovat do zdrav\u00ed, a t\u00edm podpo\u0159it konkurenceschopnost.<\/p>\n<p>Ministryn\u011b zdravotnictv\u00ed Jennifer Carroll MacNeillov\u00e1, kter\u00e1 vede resort od ledna 2025, ozn\u00e1mila, \u017ee irsk\u00e9 p\u0159edsednictv\u00ed se prim\u00e1rn\u011b zam\u011b\u0159\u00ed na zm\u011bny v na\u0159\u00edzen\u00ed o klinick\u00fdch hodnocen\u00edch. Celkov\u011b pak irsk\u00e1 zdravotnick\u00e1 agenda stoj\u00ed na t\u0159ech pil\u00ed\u0159\u00edch: l\u00e9ky a inovace, prevence a rovn\u00fd p\u0159\u00edstup ke zdravotn\u00ed p\u00e9\u010di a digit\u00e1ln\u00ed zdravotnictv\u00ed.<\/p>\n<p>Obavy o konkurenceschopnost jsou re\u00e1ln\u00e9. Eurokomisa\u0159 pro zdrav\u00ed Oliv\u00e9r V\u00e1rhelyi je podlo\u017eil \u010d\u00edsly: pod\u00edl \u010c\u00edny na celosv\u011btov\u00fdch klinick\u00fdch studi\u00edch vzrostl za deset let z necel\u00fdch 10 na t\u00e9m\u011b\u0159 30 %. Pod\u00edl Evropy za tu dobu klesl z 18 na pouh\u00fdch 9 %. P\u0159itom biotechnologie jsou jedn\u00edm z nejstrategi\u010dt\u011bj\u0161\u00edch odv\u011btv\u00ed Evropy \u2013 v\u011bt\u0161ina jeho produkce sm\u011b\u0159uje pr\u00e1v\u011b do zdravotnictv\u00ed.<\/p>\n<p>L\u00e9ky: jedna dohoda hotov\u00e1, ta t\u011b\u017e\u0161\u00ed teprve p\u0159ijde<\/p>\n<p>Pr\u00e1ce na l\u00e9kov\u00e9 legislativ\u011b u\u017e b\u011b\u017e\u00ed. Rada EU se pod kypersk\u00fdm veden\u00edm shodla v \u010dervnu na postoji ke sm\u011brnici Aktu o biotechnologi\u00edch. Ta \u0159e\u0161\u00ed zpracov\u00e1n\u00ed org\u00e1n\u016f a geneticky modifikovan\u00e9 mikroorganismy. Irsko je p\u0159ipraven\u00e9 posunout materi\u00e1l do takzvan\u00e9ho trialogu, jakmile Evropsk\u00fd parlament schv\u00e1l\u00ed sv\u00e9 stanovisko.<\/p>\n<p>Slo\u017eit\u011bj\u0161\u00ed bude vyjedn\u00e1v\u00e1n\u00ed o samotn\u00e9m na\u0159\u00edzen\u00ed Aktu o biotechnologi\u00edch. To toti\u017e obsahuje pravidla pro klinick\u00e9 studie a tak\u00e9 sporn\u00e9 patentov\u00e9 opat\u0159en\u00ed, kter\u00e9 by u n\u011bkter\u00fdch \u0161pi\u010dkov\u00fdch produkt\u016f prodlou\u017eilo patentovou ochranu o 12 m\u011bs\u00edc\u016f. V\u00fdsledkem by bylo odd\u00e1len\u00ed p\u0159\u00edchodu levn\u011bj\u0161\u00edch generick\u00fdch l\u00e9k\u016f. V\u00fdbor pro \u017eivotn\u00ed prost\u0159ed\u00ed Evropsk\u00e9ho parlamentu (ENVI) v \u010dervnu navrhl tento \u010dl\u00e1nek zcela smazat. MacNeillov\u00e1 p\u0159esto pova\u017euje cel\u00e9 na\u0159\u00edzen\u00ed za strategickou prioritu pro unijn\u00ed konkurenceschopnost a suverenitu. Apeluje proto na sv\u00e9 kolegy, aby jednali rychle.<\/p>\n<p>Na stole le\u017e\u00ed i dal\u0161\u00ed dva d\u016fle\u017eit\u00e9 l\u00e9kov\u00e9 dokumenty. U Aktu o kritick\u00fdch l\u00e9\u010divech dos\u00e1hli vyjednava\u010di v kv\u011btnu p\u0159edb\u011b\u017en\u00e9 dohody s Evropsk\u00fdm parlamentem a hlasov\u00e1n\u00ed na pl\u00e9nu se o\u010dek\u00e1v\u00e1 do 2. \u0159\u00edjna. Farmaceutick\u00fd bal\u00ed\u010dek, na n\u011bm\u017e se unie r\u00e1mcov\u011b shodla v prosinci 2025, by pak m\u011bla Evropsk\u00e1 rada pod irsk\u00fdm veden\u00edm form\u00e1ln\u011b schv\u00e1lit po letn\u00edch pr\u00e1zdnin\u00e1ch.<\/p>\n<p>    Mohlo by v\u00e1s zaj\u00edmat<\/p>\n<p>        <a href=\"https:\/\/www.zdravotnickydenik.cz\/2026\/06\/svrab-urady-ctyri-obeti-ktere-kraje-jsou-na-tom-nejhure\/\" class=\"relative block overflow-hidden rounded-lg group aspect-[3\/2] md:aspect-video min-w-[88px] sm:min-w-[175px] lg:min-w-[225px]\" aria-label=\"\u010d\u00edst v\u00edce\" rel=\"nofollow noopener\" target=\"_blank\"><br \/>\n                        <img loading=\"lazy\" decoding=\"async\" width=\"384\" height=\"256\" src=\"https:\/\/www.europesays.com\/cz\/wp-content\/uploads\/2026\/07\/pexels-towfiqu-barbhuiya-3440682-13005383-384x256.jpg\" class=\"absolute object-cover w-full h-full group-hover:scale-105 transition-all\" alt=\"\"  \/><br \/>\n                        <\/a><\/p>\n<p>Zdravotnick\u00e9 prost\u0159edky jako \u201eambici\u00f3zn\u00ed c\u00edl\u201c<\/p>\n<p>Irsko chce tak\u00e9 pohnout s dlouho odkl\u00e1danou reviz\u00ed na\u0159\u00edzen\u00ed o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR) a diagnostick\u00fdch zdravotnick\u00fdch prost\u0159edc\u00edch in vitro (IVDR), kter\u00e9 upravuje v\u0161e od ky\u010deln\u00edch implant\u00e1t\u016f po krevn\u00ed testy. C\u00edlem je zjednodu\u0161en\u00ed pravidel. \u201eStanovili jsme si ambici\u00f3zn\u00ed c\u00edl dos\u00e1hnout obecn\u00e9ho p\u0159\u00edstupu Evropsk\u00e9 rady. Pacienti na n\u00e1s spol\u00e9haj\u00ed,\u201c uvedla MacNeillov\u00e1.<\/p>\n<p>Druh\u00fdm pil\u00ed\u0159em je prevence. Irsko se zam\u011b\u0159\u00ed na urychlen\u00ed Evropsk\u00e9ho kardiovaskul\u00e1rn\u00edho pl\u00e1nu, jeho\u017e c\u00edlem je sn\u00ed\u017een\u00ed po\u010dtu \u00famrt\u00ed na nemoci srdce do roku 2035 o \u010dtvrtinu. Pr\u00e1v\u011b ty jsou toti\u017e v Evrop\u011b st\u00e1le nej\u010dast\u011bj\u0161\u00ed p\u0159\u00ed\u010dinou \u00famrt\u00ed. V listopadu proto Irsko uspo\u0159\u00e1d\u00e1 ministerskou konferenci o prevenci t\u011bchto chorob. K t\u00e9matu se vyjad\u0159uje i Evropsk\u00fd parlament \u2013 <a href=\"https:\/\/www.zdravotnickydenik.cz\/2026\/06\/eu-plan-kardiologie\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">V\u00fdbor pro ve\u0159ejn\u00e9 zdrav\u00ed schv\u00e1lil reakci na tento pl\u00e1n<\/a>, p\u0159i\u010dem\u017e europoslankyn\u011b Romana Jerkovi\u0107ov\u00e1 (S&amp;D) v n\u011bm prosazovala je\u0161t\u011b p\u0159\u00edsn\u011bj\u0161\u00ed opat\u0159en\u00ed v\u016f\u010di tab\u00e1ku a alkoholu.<\/p>\n<p>T\u0159et\u00edm pil\u00ed\u0159em je digitalizace. Irsko se zam\u011b\u0159\u00ed na zav\u00e1d\u011bn\u00ed Evropsk\u00e9ho prostoru pro zdravotn\u00ed data (EHDS), kter\u00fd m\u00e1 umo\u017enit bezpe\u010dn\u00e9 sd\u00edlen\u00ed pacientsk\u00fdch z\u00e1znam\u016f a v\u00fdzkumn\u00fdch dat nap\u0159\u00ed\u010d st\u00e1ty. K tomu se v Dublinu 13. a 14. \u0159\u00edjna uskute\u010dn\u00ed konference. P\u0159edsednictv\u00ed se chce v\u00edce v\u011bnovat tak\u00e9 zdrav\u00ed \u017een, konkr\u00e9tn\u011b endometri\u00f3ze, pro kterou uspo\u0159\u00e1d\u00e1 v Dublinu 3. prosince speci\u00e1ln\u00ed konferenci.<\/p>\n<p>T\u00edm program akc\u00ed b\u011bhem irsk\u00e9ho p\u0159edsednictv\u00ed nekon\u010d\u00ed. Sbor komisa\u0159\u016f se sejde v Corku 2. a 3. \u010dervence. MacNeillov\u00e1 bude 30. z\u00e1\u0159\u00ed a 1. \u0159\u00edjna v Dublinu p\u0159edsedat neform\u00e1ln\u00ed Rad\u011b EPSCO za \u00fa\u010dasti komisa\u0159e V\u00e1rhelyiho, region\u00e1ln\u00edho \u0159editele WHO pro Evropu a \u0161\u00e9fa Evropsk\u00e9 l\u00e9kov\u00e9 agentury (EMA). Form\u00e1ln\u00ed zased\u00e1n\u00ed Rady EPSCO prob\u011bhne 8. prosince v Bruselu. Mezit\u00edm Dublin 7. a 8. \u0159\u00edjna host\u00ed konferenci o klinick\u00fdch studi\u00edch a p\u0159\u00edstupu k l\u00e9k\u016fm.<\/p>\n<p>Pro farmafirmy i pacienty<\/p>\n<p>Pro pacienty jsou ve h\u0159e zcela konkr\u00e9tn\u00ed v\u011bci. Rychlej\u0161\u00ed klinick\u00e9 studie znamenaj\u00ed d\u0159\u00edv\u011bj\u0161\u00ed p\u0159\u00edstup k nov\u00e9 l\u00e9\u010db\u011b. Jednodu\u0161\u0161\u00ed pravidla pro zdravotnick\u00e9 prost\u0159edky zajist\u00ed, \u017ee testy a implant\u00e1ty nezmiz\u00ed z trhu. A v\u00fdsledek bitvy o patenty ur\u010d\u00ed, jak dlouho budou Evropan\u00e9 \u010dekat na levn\u011bj\u0161\u00ed l\u00e9ky.<\/p>\n<p>Irsko te\u010f mus\u00ed uk\u00e1zat, \u017ee dok\u00e1\u017ee dotahovat v\u011bci do konce. Samotn\u00e9 p\u0159edsednictv\u00ed z\u00e1kony neschvaluje, funguje jako prost\u0159edn\u00edk p\u0159i vyjedn\u00e1v\u00e1n\u00ed. \u0160est m\u011bs\u00edc\u016f je p\u0159itom kr\u00e1tk\u00e1 doba a je jasn\u00e9, \u017ee biotechnologick\u00fd z\u00e1kon, pravidla pro implant\u00e1ty i farmaceutick\u00fd bal\u00ed\u010dek se do prosince nestihnou schv\u00e1lit kompletn\u011b. Irsko v\u0161ak s\u00e1z\u00ed na to, \u017ee co pom\u016f\u017ee farmaceutick\u00e9mu pr\u016fmyslu, pom\u016f\u017ee i pacient\u016fm.<\/p>\n<p>\u010cl\u00e1nek je p\u0159evzat\u00fd ze zpravodajsk\u00e9ho port\u00e1lu EU Perspectives, kter\u00fd stejn\u011b jako Zdravotnick\u00fd den\u00edk, Ekonomick\u00fd den\u00edk a \u010cesk\u00e1 justice pat\u0159\u00ed do vydavatelstv\u00ed Media Network.<\/p>\n","protected":false},"excerpt":{"rendered":"Pod\u00edl Evropy na glob\u00e1ln\u00edch klinick\u00fdch studi\u00edch se za pouh\u00e9 desetilet\u00ed propadl na polovinu, zat\u00edmco \u010c\u00edna raketov\u011b roste. Irsko,&hellip;\n","protected":false},"author":2,"featured_media":135880,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[3],"tags":[27028,36401,36402,373,109,108,106,36403,36404,4912,36405,1617,36406],"class_list":["post-135879","post","type-post","status-publish","format-standard","has-post-thumbnail","category-evropa","tag-akt-o-biotechnologiich","tag-akt-o-kritickych-lecivech","tag-ehds","tag-eu","tag-europa","tag-europe","tag-evropa","tag-farmaceuticky-balicek","tag-irske-predsednictvi","tag-konkurenceschopnost","tag-kyperske-predsednictvi","tag-leky","tag-rada-eu"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@cz\/116848696211057332","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts\/135879","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/comments?post=135879"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts\/135879\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/media\/135880"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/media?parent=135879"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/categories?post=135879"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/tags?post=135879"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}