Európska únia je pripravená zjednodušiť pravidlá upravujúce klinické skúšanie liekov | Medicínske právo
              

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Európska únia je pripravená zjednodušiť pravidlá upravujúce klinické skúšanie liekov


 | 27.9.2012 | komentárov: 302

Exekutíva Európskej únie má predložiť nové pravidlá, ktoré majú farmaceutickým spoločnostiam a výskumu uľahčiť cezhraničné klinické skúšanie liekov, návrhom na zníženie nákladov a byrokracie.

Obrazok Európska komisia sa vyjadrila, že počet klinických testov realizovaných v Európskej únii  v posledných rokoch klesol o 15%, zatiaľ čo administratívne náklady a prieťahy sa zdvojnásobili.Výskumníci vinia z prílišných nákladov a byrokracie pravidlá EÚ zavedené v roku 2001, ktoré mali zaviesť prísnejšie kontroly monitorovania a podávania správ o klinickom skúšaní v snahe  zvýšiť bezpečnosť pacientov. Pod vplyvom súčasných pravidiel, spoločnosti a výskumníci, ktorí chcú, aby klinické skúšanie  prebiehalo vo viac ako jednom členskom štáte EÚ, musia podať osobitné žiadosti v každej krajine, kde sa klinické skúšanie vykonáva.

Európsky komisár pre zdravie a spotrebiteľskú politiku John Dalli sa vyjadril, že nové pravidlá, ktoré mali byť predstavené 17. júla  prinesú harmonizovaný  systém podávania žiadostí pre klinické skúšanie, čo znamená,  že navrhovateľ bude musieť poskytnúť informácie iba raz. Cezhraničné skúšanie  je obzvlášť významné pre testovanie liečby vzácnych chorôb, keďže v jednej krajine je často príliš málo potenciálnych pacientov vhodných na testovanie. Asi  štvrtina zo všetkých  klinických skúšaní prebiehajúcich v EÚ v súčasnosti zahŕňa tri až päť krajín, tvrdí Komisia.

Primerané štandardy

V rámci zjednodušovania pravidiel sa od Komisie očakáva, že nahradí  súčasnú smernicu EÚ, ktorú musí každý jeden členský štát implementovať do vnútroštátneho práva, nariadením, ktoré je rovnako aplikovateľné vo všetkých 27 členských krajinách. Po zverejnení, budú musieť návrh Komisie spoločne odsúhlasiť vlády členských štátov a Európsky parlament, čo môže trvať až dva roky.

Peter Liese, nemecký člen parlamentu a hovorca stredopravicovej parlamentnej skupiny- Európskej ľudovej strany (EPP), sa vyjadril, že sa snaží o opravu chýb v smernici, ktoré brzdia  klinické skúšanie v Európe  a presúvajú ho do chudobnejších krajín, akou je napríklad India.  Podľa súčasných pravidiel, klinické skúšanie vykonávané mimo Európy, musí byť realizované za splnenia  štandardov ekvivalentných štandardom EÚ, aby mohli byť použité ako základ pre schválenie nových liekov.

Liese ale tvrdí, že  zahraničné štandardy sa ťažko overujú a zahraničné klinické skúšanie  by sa nemalo používať ako základ pre schválenie nových liekov. „Je to krehká rovnováha, ale myslíme si, že máme zodpovednosť voči chudobným ľudom v Indii, ktorí riskujú svoje životy, ale taktiež voči pacientom v Európe, ktorí  nebudú  adekvátne  ošetrení kvôli údaje nie sú vygenerované za spoľahlivých podmienok,“  hovorí Liesle.

Liesle chce taktiež odlišné pravidlá  pre nekomerčné testy, ktoré vykonávajú akademici,  charity  a pacientske organizácie,  čo by umožnilo rýchlejšie  využívanie týchto informácií  a nižšiu mieru regulácie. Nekomerčné testy sú menej riskantné ako komerčné testy, pretože experimentujú s liekmi, ktoré sú už na trhu.

Preklad: Kamila Oláhová, Zuzana Zoláková
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