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Nájde etika klinického skúšania na Slovensku cestu?


 | 23.6.2014 | komentárov: 402

O etike v medicíne môžeme hovoriť od čias Hippokrata, ktorý položil základy medicíny ako vedného odboru a zároveň definoval kódex k prístupu ku chorému. Etika medicíny a zároveň experimentálnej medicíny prekonávala vzostupy a pády, ktoré počas storočí pomáhali rozvoju medicíny a k zlepšenie kvalitu liečby. S vedeckým pokrokom prerodom alchýmie na farmáciu sa otvárala aj otázka etiky výskumu na človeku.

Obrazok

V 20. storočí bolo prijatých niekoľko kľúčových dokumentov, ktoré ovplyvňujú etiku experimentu na človeku. Norimberský kódex bol zlomový dokument prijatý v roku 1947. Desať bodov Norimberského kódexu je formulovaných tak, aby pri jeho dodržiavaní boli zabezpečené práva účastníka výskumu na jeho informovanosť a dobrovoľný súhlas s experimentom.  Aj napriek Norimberskému kódexu etika skúšania na človeku nebola dodržiavaná ako jednotlivcami tak aj vládami. Ďalšie dokázané etické prešľapy vyústili v roku 1964 ku konferencii Svetovej zdravotníckej spoločnosti (WMA) a k prijatiu Helsinskej deklarácie. Helsinskú deklaráciu podpísali všetky rozvinuté krajiny (aj vtedajšia Československá socialistická republika) a stala sa etickým základom pre vykonávanie klinických skúšaní. Deklarácia bola počas rokov aktualizovaná. Posledná aktualizácia je platná od 1.1.2014, schválená na zasadaní WMA októbri 2013 v Brazílii. Následne  Európske spoločenstvo schvaľuje  v roku 1965 - usmernenie 65/65/EEC.

 


S narastajúcim rozvojom klinických skúšaní bol regulačnými orgánmi a zástupcami inovatívneho farmaceutického priemyslu Japonska, USA a Európy v roku 1996 vypracovaný a schválený medzinárodne uznávaný štandard pre vykonávanie klinického skúšania - Zásady správnej klinickej praxe (ICH GCP). S ICH GCP sa zjednotili povinnosti etických komisií, skúšajúcich a zadávateľov. Vytvoril sa tak jednotný medzinárodný etický a vedecký štandard pre návrh, vedenie, zaznamenávanie a hlásenie klinického skúšania. Následne štandardy ICH GCP sú implementované do legislatívy Európskej únie Smernica Európskeho parlamentu a Rady 2001/20/ES a do legislatív Spojených štátov amerických, Japonska a členských krajín Európskej Únie.

V ustanoveniach §16 ods. 7 zákona č. 9/2004 Z.z. (novelizujúcim okrem iného zákon č. 140/1998 Z.z. o liekoch a zdravotníckych pomôckach) (1) a v ustanoveniach §26 ods. 6 (2) a ods. 7 (3) zákona č. 576/2004 Z.z. zákona o zdravotnej starostlivosti prvý krát dostáva do slovenskej legislatívy pojem multicentrické klinické skúšanie, povinnosti etických komisií a ochrany účastníka klinického skúšania. Podľa vzoru Smernice Európskeho parlamentu a Rady 2001/20/ES (4) je do slovenskej legislatívy zapracovaná požiadavka na jedno stanovisko etickej komisie, a to aj s časovými limitmi. Za 10 rokov platnosti zákona posudzovanie etiky klinického skúšania podľa hore spomínaných zákonov je stále ako pre etické komisie, tak pre zadávateľov a skúšajúcich vykladané nejednoznačne, čo následne v niektorých prípadoch ohrozuje bezpečnosť, práva a blaho účastníkov, zároveň konkurencie schopnosť Slovenskej republiky v európskom priestore. Do dnešného dňa neexistuje Metodický pokyn/list/usmernenie, akým spôsobom má Multicentrická etická komisia postupovať pri konzultácii stanoviska k etike klinického skúšania, čo má za následok nesúrodú prácu etických komisií a nejasné pravidlá pre zadávateľa a skúšajúcich. V mnohých prípadoch sa z tohto dôvodu informácie, ktoré majú viesť k informovanosti účastníka skúšania dostávajú k účastníkovi oneskorenie a zároveň Slovenskú republiku diskvalifikuje v medzinárodnom kontexte. Prijatím nového nariadenia Európskej únie nám dáva jedinečnú šancu, aby sa zlepšila práca etických komisií, a tým by sa mala zaručiť ochrana práv, bezpečnosti a blaho účastníkov skúšania, tak ako si to vyžaduje Helsinská deklarácia, GCP a následne legislatíva.

V európskej únii fungujú 2 základné modely posudzovania etiky klinického skúšania

Prvý model platný napríklad v Maďarsku alebo Portugalsku je postavený na jednej centrálnej profesionálnej etickej komisii. Centrálna etická komisia je zriaďovaná pri regulačnom orgáne ako ďalší nezávislý orgán. Úlohou centrálnej etickej komisie je posudzovať dokumenty dané ICH GCP a legislatívou príslušnej krajiny a zároveň priamo komunikovať s etickými komisiami zúčastnených centier. Centrálna etická komisia diskutuje priamo s lokálnymi etickými komisiami vhodnosť pracoviska a dokumenty, ktoré boli poskytnuté na posúdenie. Žiadateľ zasiela iba jednu sadu dokumentov a to priamo na centrálnu etickú komisiu a centrálna etická komisia vydáva stanovisko za všetky pracoviská.

Druhý model je platný napríklad v Rakúsku, alebo v Českej republike. V týchto krajinách etické komisie môžu byť v pozícii lokálnej etickej komisie ale aj centrálnej etickej komisie. Zriaďuje ich buď inštitúcia alebo iný zriaďovateľ, pod ktorý spadá pracovisko. Tento model je tiež nastavený na jeden súhlas podľa Smernice 2001/20/ES, ktoré sa premietlo do zákona príslušnej krajiny. Aj v tomto modeli centrálna etická komisia vydáva jedno stanovisko, ktoré konzultuje s lokálnymi etickými komisiami -  buď priamo alebo cez žiadateľa. Lokálne etické komisie sa v tomto modeli vyjadrujú iba k príslušnému centru skúšania.

Pri porovnaní oboch modelov, ale platí jednotný princíp vychádzajúci z Smernice 2001/20/ES článok 7 (5). 

Centrálna (multicentrická) etická komisia posudzuje Práva, bezpečnosť a blaho účastníka skúšania na základe protokolu, príručky pre skúšajúceho a ostatných priložených dokumentov. Hodnotí pomer výhod a rizík pre účastníka. Kontroluje obsah informovaného súhlasu - jeho formu, čitateľnosť a zrozumiteľnosť, tak aby obsahoval všetky požiadavky ICH GCP a legislatívy krajiny.  Etická komisia posudzuje všetky dokumenty, ktoré idú do rúk účastníkovi skúšania, od denníkov účastníka cez informačné letáky účastníka končiac reklamných náborových letákov.  Zároveň posudzuje preplácanie kompenzácií účastníkovi skúšania (cestovné náklady, stravné…). Etická komisia má posudzovať preplácanie nákladov a ich rozvrh. Etická komisia sa zameriavať, či v skúšaní bude zachované právo na ochranu osobných údajov účastníka a poistné krytie a odškodnenie prípade ujmy účastníka skúšania.

Lokálna etická komisia posudzuje materiálne a priestorové vybavenie a personálne zabezpečenie pracoviska a o svojom stanovisku informuje Centrálnu etickú komisiu.

Domnievam sa, že ustanovenia §26 ods. 6 (6) a ods. 7 (7) zákona o zdravotnej starostlivosti  a §34 zákona č. 362/2011Z.z. o liekoch a zdravotníckych pomôckach (8) predpokladal druhý model fungovania etických komisií.
Štátny ústav pre kontrolu liečiv, tiež požaduje k platnosti svojho stanoviska iba stanovisko multicentrickej etickej komisie. No posudzovanie etiky klinického skúšania na Slovensku sa líši od etických komisií.

Žiadatelia o stanovisko k etike klinického skúšanie zasielajú na všetky etické komisie žiadosť o stanovisko so spresnením, ktorá etická komisia je multicentrická. Zo skúsenosti vieme, že multicentrické etické komisie nevedia, akým spôsobom majú konzultovať svoje stanovisko k etike klinického skúšania. Tento fakt platí aj opačne, komunikácia lokálnej etickej komisie s centrálnou etickou komisiou. Tým sa nepredvídateľne predlžuje doba posudzovania etiky klinického skúšania, ktorú najmä pociťujú skúšajúci a žiadatelia pri prvej žiadosti o posúdenie etiky klinického skúšania na etické komisie. Optimálny čas pre posudzovací proces by podľa zákona nemal presiahnuť 60 dní. Čo sa týka etických komisií, vo veľkej časti tento časový limit nie je dodržaný.

Druhý závažný fakt, ktorý ohrozuje bezpečnosť účastníkov skúšania v aktívnych klinických skúšaniach, je nedodržiavanie zákonom stanovených lehôt. Nedodržiavanie časových lehôt v niektorých prípadoch ohrozuje právo na informovanosť účastníka. Lekár (skúšajúci) je povinný informovať účastníka o všetkých nových informáciách, ale skúšajúci okrem ústneho informovania potrebuje aj písomnú informáciu, ktorá musí byť posúdená etickou komisiou. V prípade nedodržiavania časových lehôt sa ohrozuje aj právo na včasnú informovanosť účastníka.

Na Slovensku aj vo svete bolo napísaných niekoľko vecných informácií o práci členov etickej komisie. Byť členom etickej komisie je veľmi zodpovedná práca a bolo by dobré, aby si tento fakt uvedomili aj zriaďovatelia etických komisií. Etické komisie za posúdenie klinického skúšania vyberajú administratívne poplatky, ktoré sa na území Slovenskej republiky pohybujú od 0-1500 EUR. S poplatkami nad 1000 Eur patrí Slovenská republika medzi finančne najdrahšie krajiny v európskej únii.  Vo veľkej časti prípadov byť členom etickej komisie je dobrovoľnícka práca. Byť predsedom a tajomníkom etickej komisie navyše vyžaduje veľké administratívne zaťaženie. Preto považujem primerané administratívne poplatky za správne, v prípade, že sa vracajú späť do systému etických komisií a neostávajú iba na účtoch zriaďovateľa.

Vypracovanie metodického listu/usmernenia pre komunikáciu medzi etickými komisiami, ktorý by vznikol na vzájomnej dohode etických komisií, Ministerstva zdravotníctva, zadávateľov/žiadateľov, skúšajúcich prospeje odbornej obci a zároveň k ochrane práv a bezpečnosti pacienta. Zároveň Slovenská republika dá šancu v kontexte nového EÚ nariadenia č.536/2014 ku konkurencii schopnosti Slovenska a k prístupu pacientom k inovatívnej liečbe, porovnateľnej s okolitými krajinami.

 

 

Autor: Mgr. Katarína Kováčová

 

 

 

Poznámky pod čiarou

(1)    Na multicentrické klinické skúšanie sa vyžaduje stanovisko k etike klinického skúšania alebo stanovisko k zmene údajov v protokole len jednej etickej komisie pre všetky pracoviská v Slovenskej republike, ktoré sa zúčastňujú na multicentrickom klinickom skúšaní. Stanovisko k etike klinického skúšania alebo stanovisko k zmene údajov v protokole vydá etická komisia, ktorú o stanovisko požiada zadávateľ, ktorý vo svojej žiadosti výslovne uvedie, že ide o multicentrické klinické skúšanie. Etická komisia musí pred vydaním svojho stanoviska k etike klinického skúšania alebo stanoviska k zmene údajov v protokole konzultovať obsah predmetného stanoviska s etickými komisiami všetkých pracovísk v Slovenskej republike, ktoré sa zúčastňujú na multicentrickom klinickom skúšaní.
(2)    Ak sa má biomedicínsky výskum vykonať vo viacerých zdravotníckych zariadeniach ústavnej starostlivosti, jeho posúdeniu a schváleniu podľa odseku 5 písm. a) predchádza jeho preskúmanie a posúdenie etickou komisiou zriadenou poskytovateľom ústavnej starostlivosti, ktorého zdravotnícke zariadenie je koordinujúcim pracoviskom tohto výskumu.
(3)      Ak sa má biomedicínsky výskum vykonať na viacerých pracoviskách zdravotníckych zariadení ambulantnej starostlivosti, ktoré sa nachádzajú na území viac ako jedného samosprávneho kraja, jeho vykonanie posudzuje a schvaľuje samosprávny kraj, v ktorého územnej pôsobnosti má sídlo koordinujúce pracovisko tohto výskumu.
(4)    Členské štáty ustanovia postup, ktorý zabezpečí, bez ohľadu na počet etických výborov, prijatie jednotného stanoviska v mene príslušného členského štátu na účely klinických pokusov vykonávaných vo viacerých centrách obmedzených na územie jedného členského štátu. V prípade klinických pokusov vykonávaných vo viacerých centrách vo viacerých členských štátoch zároveň sa predloží jednotné stanovisko v mene každého členského štátu, ktorého sa klinický pokus týka.
(5)    Členské štáty ustanovia postup, ktorý zabezpečí, bez ohľadu na počet etických výborov, prijatie jednotného stanoviska v mene príslušného členského štátu na účely klinických pokusov vykonávaných vo viacerých centrách obmedzených na územie jedného členského štátu. V prípade klinických pokusov vykonávaných vo viacerých centrách vo viacerých členských štátoch zároveň sa predloží jednotné stanovisko v mene každého členského štátu, ktorého sa klinický pokus týka.
(6)    Ak sa má biomedicínsky výskum vykonať vo viacerých zdravotníckych zariadeniach ústavnej starostlivosti, jeho posúdeniu a schváleniu podľa odseku 5 písm. a) predchádza jeho preskúmanie a posúdenie etickou komisiou zriadenou poskytovateľom ústavnej starostlivosti, ktorého zdravotnícke zariadenie je koordinujúcim pracoviskom tohto výskumu.
(7)    Ak sa má biomedicínsky výskum vykonať na viacerých pracoviskách zdravotníckych zariadení ambulantnej starostlivosti, ktoré sa nachádzajú na území viac ako jedného samosprávneho kraja, jeho vykonanie posudzuje a schvaľuje samosprávny kraj, v ktorého územnej pôsobnosti má sídlo koordinujúce pracovisko tohto výskumu.
(8)    Na multicentrické klinické skúšanie sa vyžaduje stanovisko k etike klinického skúšania alebo stanovisko k zmene údajov v protokole len jednej etickej komisie pre všetky pracoviská v Slovenskej republike, ktoré sa zúčastňujú na multicentrickom klinickom skúšaní. Stanovisko k etike klinického skúšania alebo stanovisko k zmene údajov v protokole vydá etická komisia, ktorú o stanovisko požiada zadávateľ, ktorý v žiadosti výslovne uvedie, že ide o multicentrické klinické skúšanie. Etická komisia musí vydať písomné stanovisko do 60 dní, ak ide o podanie prvej žiadosti; do 35 dní od podania žiadosti o stanovisko k zmene údajov v protokole, ak pred vydaním stanoviska k etike klinického skúšania alebo stanoviska k zmene údajov v protokole nedostala pripomienky k obsahu predmetného stanoviska od etických komisií všetkých pracovísk v Slovenskej republike, ktoré sa zúčastňujú na multicentrickom klinickom skúšaní.





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