ODGOVORNOST PROIZVOĐAČA VAKCINE U PRAKSI EVROPSKOG SUDA PRAVDE

Marija Karanikić Mirić

Sažetak

Autorka pokušava da doprinese stišavanju bure koja se u stručnoj medicinskoj i najširoj nestručnjačkoj javnosti neopravdano podigla povodom pogrešnih medijskih interpretacija odluke Evropskog suda pravde u slučaju C–621/15 (N.W and others v Sanofi Pasteur) iz juna 2017. U tom cilju prikazuje činjenično stanje i način na koji se ovaj francuski slučaj našao pred Evropskim sudom pravde, razmatra sporna pravna pitanja i način na koji je Evropski sud na njih odgovorio, ukazuje na različitost pojmova uzročnosti u pravu i u medicinskoj nauci. Presuda Evropskog suda ne menja postojeći režim odgovornosti proizvođača vakcine, već razjašnjava standarde koje nacionalna pravila dokaznog postupka treba da ispune da ne bi bila u suprotnosti s pravilom iz čl. 4 Direktive o odgovornosti za proizvode s nedostatkom. Po tom pravilu teret dokazivanja nedostatka u proizvodu, nastale štete i uzročne veze između nedostatka i štete pada na oštećenika. Kada ne postoje naučna saznanja o tome da li je određena vakcina uzrok odnosno da li doprinosi pojavi određenog oboljenja, pravična raspodela povećanog rizika u uslovima ubrzanog tehnološkog razvoja i asimetrije informacija nalažu da se ne isključi svaka mogućnost da se uzročna veza u sudskom postupku dokazuje i drugim sredstvima, a ne samo rezultatima medicinskih istraživanja.

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PROPISI I SUDSKE ODLUKE

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