Vývoj na pôde EU: Etické komisie a informovaný súhlas v ohrození | Medicínske právo
              

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Vývoj na pôde EU: Etické komisie a informovaný súhlas v ohrození


 | 1.4.2014 | komentárov: 455

V dielni Európskej Únie sa momentálne nachádzajú dva dôležité legislatívne texty. Prvým je Nariadenie o ochrane dát (General Data Protection Regulation (2012/0011 (COD)), ktorej obsahom je zabezpečenie spracovania, ukladania a výmeny osobných dát v rámci EU, vrátane dát týkajúcich sa zdravia a zdravotnej starostlivosti. Druhým legislatívnym textom je Nariadenie o klinických testoch (Clinical Trials Regulation (2012/0192 (COD)), ktorá si kladie za cieľ podporu výskumu a vývoja liekov v Európe.

Obrazok

Oba návrhy nariadení boli schválené Európskym parlamentom. V rámci legislatívneho procesu je potrebné dosiahnuť zhodu Parlamentu s Európskou radou, ktorá je zložená z reprezentantov z 28 členských štátov. Cieľom je formálne prijať smernicu v prvej polovici roku 2014, i  keď legislatívny proces ešte nie je ešte ukončený.  Stála komisia európskych lekárov vyjadrila vážne obavy ohľadom vývoja a smerovania pojednávaní. Dôvodom je možné tendenčné správanie sa zákonodarcov a ich snaha spochybniť a oslabiť základy medicínskej etiky, obzvlášť etických komisií a taktiež udeľovania informovaného súhlasu počas výskumu.

Po prvé, etické komisie mali mať pri klinických testoch  významné postavenie v procese udeľovania povolenia a toto postavenie sa v porovnaní s prvým návrhom alarmujúco eliminovalo. V skutočnosti súčasný text smernice o klinických testoch obmedzuje funkciu etických komisií výhradne na preskúmanie testovacieho protokolu. Inými slovami, konečné rozhodnutie etických komisií založené na ohodnotení protokolu z klinických testov nebude už viac záväzné pre udelenia povolenia na vykonanie klinických testov. Je možné sa obávať, že to v tejto oblasti povedie k tomu, že klinické testy budú vykonávané i napriek negatívnemu hodnotiacemu stanovisku k testovaciemu protokolu etickou komisiou.

Ako sa uvádza vo vysvetľujúcom stanovisku k pozmeňujúcemu návrhu Výboru Európskeho parlamentu pre životné prostredie, verejné zdravie a bezpečnosť potravín k nariadeniam o klinických testoch, Komisia sa snažila vyhnúť regulovaniu etických komisií, nakoľko v rámci Európskej únie sú v rôznych štátoch rozdielne upravené. Následne je zdôraznená významná úloha etických komisií pri autorizácií klinických testov a pri zabezpečovaní bezpečnosti pacientov.

Výbor pre životné prostredie, verejné zdravie a bezpečnosť potravín vo svojom pozmeňovacom návrhu zo dňa 10.6.2013 navrhuje (1) pridať do textu nariadenia ustanovenie, podľa ktorého by mohla byť autorizácia na vykonanie klinického testu v členskom štáte udelená iba po preskúmaní žiadosti a autorizáciu etickou komisiou v súlade s Deklaráciou Svetovej medicínskej organizácie z Helsiniek. No zo znenia textu ešte priamo nevyplýva, že autorizácia musí byť v prípade negatívneho stanoviska etickej komisie automaticky odmietnutá.

Po druhé, všeobecne uznávaný etický štandard, podľa ktorého má byť  jednotlivec, ktorý sa chystá zúčastniť medicínskeho výskumného projektu, neustále informovaný o charakteristikách výskumu pred tým, ako k nemu udelí svoj súhlas, je teraz v ohrození.
Toto sa týka oboch smerníc, o ochrane dát ako aj o klinických testoch. V ich kontexte výskumný pracovník môže získať prístup k zdravotným údajom identifikujúcim jednotlivca i napriek tomu, že jednotlivec, ktorého sa tieto údaje týkajú, o tom nikdy nebol informovaný a nikdy neudelil explicitný informovaný súhlas.

Vo vysvetľujúcom memorande k legislatívnemu návrhu nariadenia o klinických testoch možno čítať, že v zmysle znenia článku 3(2)a Charty základných práv Európskej únie, žiadny zásah v oblasti medicíny a biológie nemôže byť vykonaný bez slobodného a informovaného súhlasu osoby, ktorej sa týka. A Európske právo sa musí tohto princípu pridržiavať. Navrhované nariadenie sleduje podstatu tohto princípu až na istú výnimku. Tou sú klinické testy v krízových situáciách.

Podľa článku 29 navrhovanej smernice o klinických testoch jednotlivec musí udeliť písomný súhlas po tom, ako bol plne informovaný o povahe, význame, implikáciách a možných rizikách klinického testu. Výbor pre životné prostredie, verejné zdravie a bezpečnosť potravín vo svojom pozmeňovacom návrhu číslo 167 však navrhuje pridať možnosť vykonať za istých podmienok vo výnimočných prípadoch klinický test aj bez získania informovaného súhlasu.

Môže ísť o nebezpečný krok, ktorý môže mať dopad na integritu výskumu, tak ako aj na samotných pacientov. Deklarácia Svetovej medicínskej asociácie  z Helsiniek (2) by sa totiž, i keď nejde o právne záväzný dokument, mala rešpektovať. Ak sa výskum týka ľudských bytostí, etické princípy nemôžu byť predmetom dohody.

(1) Pozmeňovací návrh č.79 k článku 3(4) Nariadenia o klinických testoch

(2) Svetová medicínska asociácia (World Medical Association-WMA) bola obnovená na stretnutí WMA vo Fortalezi v Brazílii v októbri 2013 kladie dôraz na základné etické princípy


Zdroje:
World Medical Journal, vol. 59, p.230
Legislatívny návrh nariadenia o klinických testoch General Data Protection Regulation (2012/0011 (COD)
Legislatívny návrh nariadenia o klinických testoch (Clinical Trials Regulation (2012/0192 (COD))
Report from 10.6.2013 of the Committee on the Environment, Public Health and Food Safety report tabled for plenary, 1st reading/single reading www.europarl.europa.eu/oeil/popups/summary.do?id=1274291&t=e&l=en

OPINION OF THE COMMITTEE ON INDUSTRY, RESEARCH AND ENERGY (21.3.2013)
for the Committee on the Environment, Public Health and Food Safety on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM(2012)0369 – C7-0194/2012 – 2012/0192(COD)

Foto: freedigitalphotos

Spracovala: Lenka Mišová



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