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Hospital Pharmacology - International Multidisciplinary Journal
2015, vol. 2, br. 1, str. 189-198
jezik rada: engleski
vrsta rada: članak
doi:10.5937/hpimj1501189Z
Osiguranje kliničkih ispitivanja u Srbiji
MARFI-PE Insurance Broker Co. Ltd, Belgrade

e-adresa: zlatko.zagar@marfi-pe.co.rs

Sažetak

Pre početka kliničkih ispitivanja u Srbiji zakonska je obaveza sponzora da obezbedi polisu osiguranja koja bi pacijentima koji se podvrgavaju kliničkim ispitivanjima obezbedila novčanu nadoknadu u slučaju povrede tela ili zdravlja kao posledice kliničkih ispitivanja. Saglasno odredbama važećeg Zakona o osiguranju Republike Srbije polise osiguranja se moraju ugovarati kod društava za osiguranje osnovanih u Republici Srbiji. Svaki ugovor o osiguranju zaključen suprotno ovim odredbama je ništav. Jedini izuzetak je ukoliko je u stranoj polisi za osiguranje od odgovornosti prilikom kliničkih ispitivanja izričito navedeno da je tim ugovorom o osiguranju prihvaćena nadležnost domaćih srpskih sudova i drugih organa Republike Srbije koji odlučuju o zahtevima za naknadu štete (što se do sada nikada nije desilo u praksi u Srbiji). Ova zakonska obaveza se postiže ugovaranjem polise osiguranja od odgovornosti prilikom kliničkih ispitivanja lekova (Clinical Trial Laibility Policy). Ovakve polise osiguranja izdaje nekoliko osiguravajućih društava u Srbiji. Kod ove vrste osiguranja osiguranici su sponzor, zdravstvene ustanove gde se vrše klinička ispitivanja, glavni istraživači koji sprovode klinička istraživanja i njihovi asistenti. Korisnici naknade iz osiguranja su pacijenti i/ili njihove porodice (naslednici). Obaveza osiguravajućeg društva po ovim uslovima osiguranja nastaje kada se desi osigurani slučaj odnosno kada usled kliničkog ispitivanja leka dođe do povrede tela, psihičke i duševne bolesti, psihičkih oštećenja, oboljenja, invalidnosti, šoka, bolesti ili bolešću izazvane smrti. Obaveza osiguravača ograničena je limitom pokrića po jednom osiguranom slučaju i/ili godišnjim limitom pokrića. Imajući u vidu dosadašnju sudsku praksu u Republici Srbiji iznos od EUR 500.000 do EUR 1.000.000 u dinarskoj protivvrednosti može se smatrati za sumu osiguranja koja za sada zadovoljava zahteve ispunjenja obaveze o zaključenju ovog osiguranja. Ukoliko dođe do slučaja za koji je predviđeno osiguranje, Osiguravajuća Kompanija treba da pokriva sledeće: materijalne i nematerijalne štete/gubitke oštećenoga, tj. korisnika osiguranja; izgubljenu finansijsku dobit oštećenoga, tj. korisnika osiguranja; troškove neophodne za odstranjivanje nematerijalnih i materijalnih gubitaka oštećenoga, tj. korisnika osiguranja; parnične troškove. Zakon o obligacionim odnosima propisuje da su rokovi za podnošenje odštetnih zahteva prema osiguravajućim društvima tri godine, računajući od prvog dana posle proteka kalendarske godine u kojoj je potraživanje nastalo. Ako zainteresovano lice dokaže da do dana određenog u prethodnom stavu nije znalo da se osigurani slučaj dogodio, zastarevanje počinje od dana kad je za to saznalo, s tim da u svakom slučaju potraživanje zastareva za pet godina računajući od prvog dana posle proteka kalendarske godine u kojoj je potraživanje nastalo.

Ključne reči

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