{"id":1599,"date":"2026-02-19T09:23:07","date_gmt":"2026-02-19T09:23:07","guid":{"rendered":"https:\/\/www.europesays.com\/cz\/1599\/"},"modified":"2026-02-19T09:23:07","modified_gmt":"2026-02-19T09:23:07","slug":"evrope-ujizdi-vlak-v-testovani-leku-valcuje-ji-cina-hrozi-zpomaleni-inovaci","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/cz\/1599\/","title":{"rendered":"Evrop\u011b uj\u00ed\u017ed\u00ed vlak v testov\u00e1n\u00ed l\u00e9k\u016f, v\u00e1lcuje ji \u010c\u00edna. Hroz\u00ed zpomalen\u00ed inovac\u00ed"},"content":{"rendered":"

Evropa sice testuje mnoho nov\u00fdch l\u00e9k\u016f, ale v\u011bt\u0161inou ne v prvn\u00edch f\u00e1z\u00edch. V nich dominuje \u010c\u00edna. Podle expert\u016f je to z\u00e1sadn\u00ed chyba, kter\u00e1 m\u016f\u017ee zbrzdit rychlost l\u00e9ka\u0159sk\u00fdch inovac\u00ed v EU.<\/p>\n

Ne\u00fa\u010dast na ran\u00fdch f\u00e1z\u00edch klinick\u00fdch studi\u00ed p\u0159in\u00e1\u0161\u00ed Evrop\u011b konkuren\u010dn\u00ed nev\u00fdhodu. To, kde doch\u00e1z\u00ed k prvotn\u00edmu testov\u00e1n\u00ed, toti\u017e \u010dasto rozhoduje, kde se bude odehr\u00e1vat dal\u0161\u00ed v\u00fdvoj l\u00e9ku. \u201eAbychom byli centrem v\u00fdzkumu a v\u00fdvoje pro farmaceutick\u00fd pr\u016fmysl, pot\u0159ebujeme p\u0159il\u00e1kat klinick\u00e9 studie v ran\u00e9 f\u00e1zi I, proto\u017ee investice pak \u010dasto z\u016fst\u00e1vaj\u00ed v dan\u00e9 zemi nebo regionu,\u201c vysv\u011btlil na ned\u00e1vn\u00e9m f\u00f3ru o klinick\u00fdch studi\u00edch po\u0159\u00e1dan\u00e9m belgick\u00fdm farmaceutick\u00fdm pr\u016fmyslem Peter Arlett z Evropsk\u00e9 agentury pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky (EMA).<\/p>\n

Evropa n\u011bkde vzadu<\/p>\n

\u017de v Evrop\u011b doch\u00e1z\u00ed k v\u00fdrazn\u00e9mu poklesu studi\u00ed prov\u00e1d\u011bn\u00fdch ve f\u00e1zi I, jasn\u011b ukazuj\u00ed data z anal\u00fdzy zve\u0159ejn\u011bn\u00e9 Evropskou federac\u00ed farmaceutick\u00e9ho pr\u016fmyslu a asociac\u00ed (EFPIA) a spole\u010dnost\u00ed IQVIA.<\/p>\n

Prohlubuje se nav\u00edc kontrast s \u010c\u00ednou, kde naopak po\u010det ran\u00fdch f\u00e1z\u00ed studi\u00ed nar\u016fst\u00e1, a to p\u0159edev\u0161\u00edm v oblasti bun\u011b\u010dn\u00fdch a genov\u00fdch terapi\u00ed a radiofarmak. Podle \u010d\u00ednsk\u00e9 v\u00fdro\u010dn\u00ed zpr\u00e1vy o pokroku v klinick\u00fdch studi\u00edch pro registraci nov\u00fdch l\u00e9k\u016f za rok 2024 tvo\u0159ily studie f\u00e1ze I t\u00e9m\u011b\u0159 40 % v\u0161ech studi\u00ed nov\u00fdch l\u00e9k\u016f a t\u00e9m\u011b\u0159 polovinu studi\u00ed inovativn\u00edch l\u00e9k\u016f.<\/p>\n

Studie f\u00e1ze I nav\u00edc v \u010c\u00edn\u011b p\u0159edstavovaly t\u00e9m\u011b\u0159 t\u0159i \u010dtvrtiny dokon\u010den\u00fdch studi\u00ed, co\u017e odr\u00e1\u017e\u00ed tamn\u00ed rychlost i v\u00fdkonnost. V Evrop\u011b tento kontrast vyvol\u00e1v\u00e1 obavy z toho, \u017ee na star\u00e9m kontinentu dojde k oslaben\u00ed p\u0159\u00edpravy budouc\u00edch studi\u00ed.<\/p>\n

Mohlo by v\u00e1s zaj\u00edmat<\/p>\n


\n \"\"
\n <\/a><\/p>\n

\u010c\u00edna u kormidla<\/p>\n

Vzestup \u010c\u00edny na poli ran\u00fdch f\u00e1z\u00ed studi\u00ed se odr\u00e1\u017e\u00ed i ve zv\u00fd\u0161en\u00e9m z\u00e1jmu nadn\u00e1rodn\u00edch farmaceutick\u00fdch firem. Minul\u00fd t\u00fdden se spole\u010dnost AstraZeneca zav\u00e1zala investovat 15 miliard dolar\u016f do roz\u0161\u00ed\u0159en\u00ed sv\u00fdch aktivit v \u010c\u00edn\u011b do roku 2030. Jej\u00ed investice p\u016fjdou do ran\u00e9ho v\u00fdzkumu, klinick\u00e9ho v\u00fdvoje a v\u00fdroby. AstraZeneca provozuje glob\u00e1ln\u00ed strategick\u00e1 v\u00fdzkumn\u00e1 a v\u00fdvojov\u00e1 centra v Pekingu a \u0160anghaji, kter\u00e1 spolupracuj\u00ed s v\u00edce ne\u017e 500 klinick\u00fdmi nemocnicemi a za posledn\u00ed t\u0159i roky vedla v \u010c\u00edn\u011b velk\u00e9 mno\u017estv\u00ed glob\u00e1ln\u00edch klinick\u00fdch studi\u00ed.<\/p>\n

Hodnocen\u00ed spole\u010dnosti McKinsey<\/a> t\u00fdkaj\u00edc\u00ed se boomu klinick\u00e9ho v\u00fdzkumu v \u010c\u00edn\u011b ukazuje, \u017ee si zem\u011b zkr\u00e1tila cestu od objevu k prvn\u00edm studi\u00edm na lidech o 50\u201370 % ve srovn\u00e1n\u00ed s glob\u00e1ln\u00edm pr\u016fm\u011brem. \u010c\u00edn\u011b k tomu pom\u00e1h\u00e1 velk\u00e1 s\u00ed\u0165 nemocnic, rychlost regulac\u00ed i hustota smluvn\u00edch v\u00fdzkumn\u00fdch a v\u00fdvojov\u00fdch organizac\u00ed.<\/p>\n

T\u0159i z\u00e1sadn\u00ed oblasti<\/p>\n

\u010c\u00ednsk\u00e1 a obecn\u011b i glob\u00e1ln\u00ed konkurence st\u00e1le zrychluje. A Evropa se sna\u017e\u00ed neztratit s n\u00ed kontakt. \u201eSv\u011bt za posledn\u00ed rok nez\u016fstal st\u00e1t na m\u00edst\u011b. A stejn\u011b tak ani evropsk\u00fd ekosyst\u00e9m klinick\u00fdch studi\u00ed,\u201c uvedla \u0159editelka pro regula\u010dn\u00ed politiku EFPIA Katarina Nedogov\u00e1 na zm\u00edn\u011bn\u00e9m f\u00f3ru o klinick\u00fdch studi\u00edch.<\/p>\n

Pokrok podle n\u00ed v Evrop\u011b prob\u00edh\u00e1 na t\u0159ech front\u00e1ch najednou. A ne\u00fasp\u011bch na jedn\u00e9 z nich m\u016f\u017ee ohrozit ostatn\u00ed. Prvn\u00ed oblast je struktur\u00e1ln\u00ed. Navrhovan\u00fd z\u00e1kon o biotechnologi\u00edch spolu s c\u00edlen\u00fdmi zm\u011bnami evropsk\u00fdch pravidel pro in vitro diagnostick\u00e9 zdravotnick\u00e9 prost\u0159edky (IVDR) a evropsk\u00e9ho na\u0159\u00edzen\u00ed o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR) maj\u00ed za c\u00edl resetovat r\u00e1mec pro p\u0159\u00ed\u0161t\u00ed desetilet\u00ed. C\u00edlem je syst\u00e9m, kter\u00fd bude p\u0159edv\u00eddateln\u011bj\u0161\u00ed a p\u0159im\u011b\u0159en\u011bj\u0161\u00ed, s krat\u0161\u00edmi a harmonizovan\u011bj\u0161\u00edmi lh\u016ftami, siln\u011bj\u0161\u00ed koordinac\u00ed prost\u0159ednictv\u00edm \u010dlensk\u00e9ho st\u00e1tu pod\u00e1vaj\u00edc\u00edho zpr\u00e1vy, men\u0161\u00edm mno\u017estv\u00edm duplicit d\u00edky modelu z\u00e1kladn\u00edho spisu a jednotnou cestou pro kombinovan\u00e9 studie l\u00e9k\u016f, prost\u0159edk\u016f a diagnostiky.<\/p>\n

Druh\u00e1 oblast je experiment\u00e1ln\u00ed. Vzhledem k tomu, \u017ee legislativa je st\u00e1le v pohybu, evropsk\u00e9 iniciativy jako FAST-EU a COMBINE se vyu\u017e\u00edvaj\u00ed k testov\u00e1n\u00ed, zda rychlej\u0161\u00ed a koordinovan\u011bj\u0161\u00ed regula\u010dn\u00ed postupy mohou fungovat v praxi. A to zejm\u00e9na u nadn\u00e1rodn\u00edch a komplexn\u00edch studi\u00ed v r\u00e1mci sou\u010dasn\u00fdch pravidel.<\/p>\n

T\u0159et\u00ed d\u016fle\u017eitou oblast\u00ed je rychlost. Podle st\u00e1vaj\u00edc\u00edho na\u0159\u00edzen\u00ed o klinick\u00fdch hodnocen\u00edch ukazuj\u00ed \u00fadaje EFPIA jist\u00fd paradox. N\u00e1rodn\u00ed hodnocen\u00ed sice mohou postupovat rychle, multin\u00e1rodn\u00ed a inovativn\u00ed studie v\u0161ak st\u00e1le nar\u00e1\u017eej\u00ed na zpo\u017ed\u011bn\u00ed, administrativn\u00ed z\u00e1t\u011b\u017e a provozn\u00ed nesrovnalosti.<\/p>\n

Evropa nem\u016f\u017ee podle Nedogov\u00e9 \u017e\u00e1dnou z t\u011bchto t\u0159\u00ed oblast\u00ed podcenit. \u201eNem\u016f\u017eeme dos\u00e1hnout vynikaj\u00edc\u00edch v\u00fdsledk\u016f v jedn\u00e9 oblasti a kompenzovat t\u00edm nedostatek \u00fasp\u011bch\u016f v jin\u00e9,\u201c uvedla.<\/p>\n

Poda\u0159\u00ed se naplnit stanoven\u00e1 \u010d\u00edsla?<\/p>\n

Ambice Evropy jsou jasn\u011b vyj\u00e1d\u0159en\u00e9 i v konkr\u00e9tn\u00edch \u010d\u00edslech. Evropsk\u00e1 s\u00ed\u0165 pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky stanovila na\u0161emu kontinentu dva hlavn\u00ed c\u00edle. Do roku 2030 m\u00e1 b\u00fdt provedeno dal\u0161\u00edch 500 multin\u00e1rodn\u00edch klinick\u00fdch hodnocen\u00ed. A dv\u011b t\u0159etiny studi\u00ed maj\u00ed zah\u00e1jit n\u00e1bor \u00fa\u010dastn\u00edk\u016f do 200 dn\u016f od pod\u00e1n\u00ed \u017e\u00e1dosti. Podle n\u011bkter\u00fdch expert\u016f jde o m\u00e1lo ambici\u00f3zn\u00ed c\u00edl, jin\u00ed se boj\u00ed, \u017ee se jej nepoda\u0159\u00ed naplnit.<\/p>\n

O probl\u00e9mu se diskutovalo i na Evropsk\u00e9 konfederaci farmaceutick\u00fdch podnikatel\u016f (EUCOPE). Pro italskou farmaceutickou spole\u010dnost Menarini z\u016fst\u00e1v\u00e1 priorita nepochybn\u00e1. \u201eKl\u00ed\u010dov\u00e1 je reforma regulace klinick\u00fdch studi\u00ed pro v\u0161echny produkty a zaji\u0161t\u011bn\u00ed toho, aby byl tento proces mnohem efektivn\u011bj\u0161\u00ed a dok\u00e1zal dohnat jin\u00e9 regiony, kter\u00e9 postupuj\u00ed bleskovou rychlost\u00ed, jako je \u010c\u00edna,\u201c \u0159ekl vedouc\u00ed odd\u011blen\u00ed vl\u00e1dn\u00edch z\u00e1le\u017eitost\u00ed a ochrany pacient\u016f t\u00e9to spole\u010dnosti Emanuele Degortes.<\/p>\n

Jin\u00ed zd\u016fraznili, \u017ee pokrok nez\u00e1vis\u00ed na op\u011btovn\u00e9m otev\u0159en\u00ed legislativy. Alexander Natz, gener\u00e1ln\u00ed tajemn\u00edk EUCOPE, pouk\u00e1zal na provozn\u00ed p\u0159ek\u00e1\u017eky v r\u00e1mci st\u00e1vaj\u00edc\u00edho r\u00e1mce. \u201eNemus\u00edme v\u017edy m\u011bnit na\u0161i legislativu,\u201c uvedl. Administrativn\u00ed z\u00e1t\u011b\u017e a v\u00fdkonnost syst\u00e9mu jsou podle n\u011bj nyn\u00ed d\u016fle\u017eit\u011bj\u0161\u00ed ne\u017e nov\u00e1 pravidla.<\/p>\n

T\u00e9ma se brzy do\u010dk\u00e1 i projedn\u00e1v\u00e1n\u00ed na \u00farovni ministr\u016f. 26. \u00fanora se minist\u0159i zdravotnictv\u00ed EU sejdou v kypersk\u00e9 Lefkosii na neform\u00e1ln\u00edm zased\u00e1n\u00ed EPSCO (Rada pro zam\u011bstnanost, soci\u00e1ln\u00ed politiku, zdrav\u00ed a ochranu spot\u0159ebitele, pozn. red.). Jedna z jeho \u010d\u00e1st\u00ed bude v\u011bnovat my\u0161lence evropsk\u00e9ho centra klinick\u00e9 excelence pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky. Diskuse, kter\u00e9 bude p\u0159edsedat kypersk\u00fd ministr zdravotnictv\u00ed Neophytos Charalambides, prov\u011b\u0159\u00ed, zda je Evropa p\u0159ipravena prom\u011bnit ambice v oblasti klinick\u00fdch hodnocen\u00ed v koordinovan\u00e9 politick\u00e9 kroky.<\/p>\n

\u010cl\u00e1nek byl 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":"Evropa sice testuje mnoho nov\u00fdch l\u00e9k\u016f, ale v\u011bt\u0161inou ne v prvn\u00edch f\u00e1z\u00edch. V nich dominuje \u010c\u00edna. Podle expert\u016f…\n","protected":false},"author":2,"featured_media":1600,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[202,1614,373,109,108,106,1615,1616,1617,1618,1619],"class_list":{"0":"post-1599","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-evropa","8":"tag-cina","9":"tag-ema","10":"tag-eu","11":"tag-europa","12":"tag-europe","13":"tag-evropa","14":"tag-inovace","15":"tag-klinicke-studie","16":"tag-leky","17":"tag-testovani","18":"tag-testovani-leku"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts\/1599","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=1599"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/posts\/1599\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/media\/1600"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/media?parent=1599"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/categories?post=1599"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/cz\/wp-json\/wp\/v2\/tags?post=1599"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}