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Hosť mesiaca máj Slavomíra Henčeková. II. časť


 | 11.5.2016 | komentárov: 223

Mgr. Slavomíra Henčeková vyštudovala Právnickú fakultu Univerzity Komenského v Bratislave. Kvôli doktorandskému štúdiu sa presťahovala do Prahy, kde v súčasnosti študuje na Právnickej fakulte Univerzity Karlovej v obore teórie, filozofie a sociológie práva a spolupracuje s Centrom právnej komparatistiky zaoberajúcim sa súkromným právom z komparatívneho pohľadu. Okrem toho pôsobí ako advokátska koncipientka v advokátskej kancelárii JUDr. Jana Marečková v Prahe, ktorá sa špecializuje na farmaceutické a zdravotnícke právo.

Obrazok

Posuňme sa od cien a úhrad k registrácii liekov. Ako prebieha proces schvaľovania liekov v ČR? Je tento proces porovnateľný s procesom schvaľovania liekov v SR?

Ak sa chce liek dostať na trh, musí vždy prejsť registračným konaním. Registrácia prebieha buď na národnej úrovni, alebo na úrovni EÚ. Presnejšie je možné registrovať liek (i) len v ČR v konaní pred Štátnym ústavom pre kontrolu liečiv (národná registrácia), (ii) v ČR a následne si nechať túto registráciu uznať aj v iných štátoch EÚ (registrácia procedúrou vzájomného uznávania), (iii) naraz vo viacerých štátoch EÚ bez prvotnej registrácie v ČR (decentralizovaná registrácia), alebo (iv) registrácia Európskou liekovou agentúrou, ktoré platí pre celé územie Spoločenstva EÚ.  Registračný proces je obdobný aj v SR. Česká právna úprava je obsiahnutá predovšetkým v zákone č. 378/2007 Sb. o léčivech, slovenská zase v zákone č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach. Princípy sú rovnaké, rovnaký je aj regulačný orgán – Štátny ústav pre kontrolu liečiv. 

Kto alebo čo zaručuje, že sa k pacientom dostane iba bezpečný liek? Kto zodpovedá za bezpečnosť lieku a za prípadnú škodu, ktorá vznikne v procese skúšania?

Bezpečnosť lieku sa v prvom rade posudzuje v rámci klinického skúšania, následne musí byť preukázaná v rámci už spomenutého registračného konania. Zárukou bezpečnosti lieku je tak pred vstupom lieku na trh práve klinické skúšanie a registračné konanie. Za bezpečnosť klinického skúšania zodpovedá predovšetkým zadávateľ klinického skúšania. Otázka, ako je to zo zodpovednosťou za škodu, ktorá vznikne v rámci klinického skúšania, nie je ale úplne jednoduchá. Zákon o léčivech sa k zodpovednosti za škodu vyjadruje iba na jedinom mieste, a to v § 53 ods. 3 písm. f), kde stanovuje, že zadávateľ je povinný zaistiť uzavretie poistenia zodpovednosti za škodu skúšajúceho a zadávateľa, ktorého prostredníctvom je zaistené aj odškodnenie v prípade smrti či škody na zdraví subjektu hodnotenia v dôsledku vykonávania klinického skúšania. Zákon pritom nestanovuje žiadne ďalšie podmienky tohto poistenia ako napr. minimálne poistné krytie. V prípade, že by vznikla škoda subjektu hodnotenia v rámci klinického skúšania, bola by krytá práve z tohto poistenia. Pre posúdenie otázky zodpovednosti za škodu je rozhodujúci ďalej i občiansky zákonník a ustanovenia o škode spôsobenej vecou (§ 2936 a násl. zákona č. 89/2012 Sb.), ktorý zakotvuje tzv. absolútnu objektívnu zodpovednosť, t.j. zodpovednosť, ktorej sa nie je možné zbaviť. Ďalšie podmienky zodpovednosti za škodu sú obsiahnuté v zmluvách medzi zadávateľmi a skúšajúcimi. I keď za škodu vzniknutú počas klinického skúšania zodpovedá predovšetkým zadávateľ, nemusí tak tomu byť vždy, záleží od konkrétnych okolností, ako škoda vznikla. Treba povedať aj to, že otázka, kto a za akých podmienok zodpovedá za škodu pri klinickom skúšaní, nie je definitívne právne vyriešená. Ak skutočne ku škode v priebehu klinického skúšania dôjde, skončí to totiž väčšinou mimosúdnym vyrovnaním. Judikatúra v tejto veci preto takmer neexistuje. 

Je bezpečnosť lieku sledovaná aj po tom ako bol schválený a „uvedený na trh?“

Samozrejme. Bohužiaľ nie je možné úplne eliminovať všetky riziká spojené s užívaním liekov. Bezpečnosť lieku po uvedení na trh sa preto sleduje, a to dokonca viacerými spôsobmi – hlásením nežiaducich účinkov pacientmi, lekármi alebo zdravotníckymi pracovníkmi Štátnemu ústavu pre kontrolu liečiv, hlásením podozrenia na vady v akosti lieku predovšetkým osobami, ktoré liek vydávajú, resp. predávajú, či distribuujú, ale i pacientmi a v podstate kýmkoľvek, komu sa zdá, že kvalita lieku nie je bezchybná opäť Štátnemu ústavu pre kontrolu liečiv, či hlásením podozrení na nelegálne lieky či neregistrované lieky komu inému než Štátnemu ústavu pre kontrolu liečiv. Držitelia rozhodnutí o registrácii liekov sú ďalej povinní zasielať pravidelné správy o bezpečnosti lieku. Štátny ústav pre kontrolu liečiv vedie farmakovigilančný systém, v ktorom zhromažďuje všetky údaje o bezpečnosti liekov, povinnosť viesť vlastný farmakovigilančný systém majú i držitelia rozhodnutí o registrácii. Tí môžu uskutočňovať taktiež tzv. neintervenčné poregistračné štúdie bezpečnosti, v rámci ktorých overujú i to, či daný liek stále spĺňa požiadavky, ktoré sú na neho kladené s ohľadom na bezpečnosť. 

Môžem si zo zahraničia doniesť liek, ktorý u nás nie je schválený?

Myslím, že z predchádzajúcich viet je pomerne jasné, že pravidlá na úseku liekov sú prísne, takže odpoveď je v zásade nie. Vyplýva to z § 75 ods. 1 zákona o léčivech. Aj z tohto pravidla ale existujú výnimky, na ktoré toto ustanovenie odkazuje. Za určitých podmienok Vám neregistrovaný liek môže predpísať lekár. Je to v prípadoch, ak nie je k dispozícii registrovaný liek, ten je ale registrovaný niekde v zahraničí a jeho použitie je odôvodnené vedeckými poznatkami. Ide o tzv. individuálny dovoz, za použitie tohto lieku plne zodpovedá zdravotnícke zariadenie, do úvahy prichádza i jeho úhrada, ak bude vopred schválená revíznym lekárom zdravotnej poisťovne. Tou druhou výnimkou je zaradenie lieku do tzv. špecifického liečebného programu. Ten je možné povoliť v prípade opäť nedostupnosti registrovaného lieku, ktorý je určený pre stavy závažne ohrozujúce ľudské zdravie. Každopádne ale nie je možné len tak dovážať liek kdesi z Ázie, ak nie je u nás registrovaný. 

Ďakujeme za rozhovor




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