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2015, vol. 2, br. 1, str. 189-198
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Osiguranje kliničkih ispitivanja u Srbiji
Clinical trial insurance in Serbia
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.
Abstract
Prior the commencement of the clinical trial in Serbia the Sponsor is obliged to provide the insurance policy covering the patient's bodily injury and damaged health caused by the clinical trial. According to provisions of Serbian Insurance law insurance polices have to be issued by the insurance companies established in Serbia. Every insurance policy not issued by the insurance company established in Serbia shall be deemed as null and void. The only expectance, is when the foreign clinical trial liability policy is stipulated that the insurance contract acknowledges the jurisdiction of Serbian domestic courts and other Serbian authorities to decide on damage claims (that never happened in Serbian practice). The Sponsor will fulfill this obligation stipulated in Serbian law when provides the Clinical Trial Liability policy issued by the Serbian insurance company. Nowadays, few of Serbian insurance companies are issuing such polices. Under the clinical trial liability insurance cover the insured's are: Sponsor, Medical Centers in Serbia performing or controlling the clinical trial, Principal Investigators and their assistant staff performing or controlling the clinical trial. The beneficiaries of the insurance cover are patients and/or members of their families - inheritresses. The insurance company will indemnify the beneficiary mentioned in the policy when the insured event occurred i.e. when occurred bodily injury, psychic disease and alienation, psychic damages, illnesses and deaths caused by the clinical trial. The amount of indemnity by the insurance company to the beneficiaries is limited by the amount of sum insured per occurrence and/or by the total amount of the sum insured for the total period of the insurance cover. According to case-law in Serbia the total sum insured between EUR 500.000 and EUR 1.000.000 is considered as sufficient so far to indemnify the patients in case of the insured event. If an insurance event occurs the benefits provided by the insurance company shall cover the following: non-financial losses of the claimant; financial benefits lost by the claimant; costs necessary for the elimination of the non-financial and financial losses of the claimant; costs of litigation. Serbian Law on Obligations stipulates that claims of the policy holder or third party are time bared for three years, reckoning from the first day upon expiration of the calendar year in which a claims was caused. If the interested party proves that until date defined in above paragraph it was not aware that insured event had happened, the time bar period commences from the day of awareness, but in any case a claim is time bared for five years, reckoning from the first day upon expiration of the calendar year in which a claims was caused.
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