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Clinical Trial Insurance in Serbia A ISSN 2334-9492 (Online) Hospital Pharmacology. 2015; 2(1):189-198 UDC: 616-071:368.9.06(497.11) doi:10.5937/hpimj1501189Z Clinical Trial Insurance in Serbia A Zlatko A. Žagar A Education article MARFI-PE Insurance Broker Co. Ltd. Belgrade A SUMMARY Prior the commencement of the clinical trial in Serbia the Sponsor is obliged to pro- vide 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 exceptance, 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 happend in Serbian practice). The Sponsor will fulfi ll this obligation stipulated in Serbian law when provides the Clinical Trial Liability policy issued by the Serbian insurance company. Nowadays, few of Serbian inusrance companies are issuing such polices. Under the clinical trial liability insurance cover the insureds 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 benefi ciaries of the insurance cover are patients and/or members of their families – inheritresses. The insurance company will indemnify the benefi ciary 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 benefi ciaries 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 suffi cient so far to indemnify the patients in case of the insured event. If an insurance event occurs the benefi ts provided by the insurance company shall cover the following: non-fi nancial losses of the claimant; fi nancial benefi ts lost by the claimant; costs necessary for the elimination of the non-fi nancial and fi nancial 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 fi rst day upon expiration of the calendar year in which a claims was caused. If the interested party proves that until date defi ned in above paragraph it was not aware that insured event had happened, the time bar period commences from the day of awarnes, but in any case a claim is time bared for fi ve years, reckoning from the fi rst day upon expiration of the calendar year in which a claims was caused. Keywords: clinical trials, research, investigator, patients insurance, regulations Corresponding author: Zlatko A. Žagar, LLB © The Serbian Medical Society 2014 Director MARFI-PE Iinsurance Broker Co. Ltd. Belgrade, 5/7 Budimska, 11000 Belgrade, Serbia E-mail: zlatko.zagar@marfi -pe.co.rs 189 Hospital Pharmacology. 2015; 2(1):189-198 INTRODUCTION damage is caused by the clinical trial of medic- inal product, pursuant to the Law, as well as to Within the comprehensive Clinical Trials determine by the contract the amount of nec- procedure in Serbia the very important issue essary costs that belong to the persons partici- and theme is insurance of Participants tak- pating in the clinical trial. Sponsor of clinical ing part in Clinical Trial. Th ere are still no trials of veterinary medicinal products must literatures, expert’s analyzes or clinical trial specify in the contract the amount of compen- insurance guidelines in Serbia covering this sation to be paid to the animal owners, in case theme. Our intention with the text bellow is of the damage caused by the clinical trial [4]. to pay attention to some important aspects of Law on Patients’ rights (“Offi cial Gazette of this issue and furthermore to help and assist the Republic of Serbia” No. 45/2013) stipulates various sponsors (mainly from the abroad), that the Medical Center in Serbia, prior to the clinical research organizations, medical cen- commencement of a clinical trial, must insure ters, principal investigators, patients, authori- the persons subjected to the clinical trials in ties and other persons or entities involved in case damages occur as to the health of those Clinical Trials in Republic of Serbia to arrange persons, all in accordance with Serbian Law adequate insurance policy in accordance with [5]. the Serbian Law. Ordinance on Content of Claims or Docu- mentaion for Approval of Clinical Trials of METHODOLOGY Medicaments and Medical Devices, as well as on the Procedure of Clinical Trials of Me- In this text the author has used positive Ser- dicaments and Medical Devices (“Offi cial bian law an regulations and insurance condi- Gazette of the Republic of Serbia” No. 64/2011 tions issued by Serbian insurance companies. and No. 91/2013) stipulates that Documenta- tion for approval of Clinical Trials includes the TOPIC Evidence that the sponsor has insured all Pa- tients included inthe clinical trials in the event of damage to their health within the period of 1. Stipulations of the Law in Serbia as regards the clinical trial [6] and that prior to the com- of Insurance of Patients included in Clinical mencement of clinical trials the Sponsor has Trials in Serbia insured all Patients included in Clinical Trial, in accordance with the law, for the case of Generally, as stipulated in Serbian Insurance damage to the health of patients, caused by the Law (“Offi cial Gazette of the Republic of Ser- clinical trial [7]. bia” No. 55/2004, 70/2004, 61/2005, 61/2005– other Law, 85/2005–other Law and 101/2007, Where to arrange Clinical Trial insurance? 107/2009, 99/2011, 119/2012 and 116/2013) the property and personal insurance in Ser- Insurance Law of Serbia stipulates that Prop- bia are voluntary [1]. As an exception from erty and Persons in the Republic of Serbia can that provision, the insurance of property and only be insured with the insurance companies persons is compulsory in cases regulated by established in compliance with that Law ie. the law [2]. In new Serbian Insurance Law with the insurance companies registered in the (“Offi cial Gazette of the Republic of Serbia” No. Republic of Serbia aft er approval of National 139/2014) which will apply from June 26, 2015 bank of Serbia [8]. All insurance contracts these stipulations are not modifi ed [3]. concluded contrary to this Article are null and Based on such provision of the Insurance void [9]. Law the Insurance of Patients included in As an exception from this stipulation prop- Clinical Trials in Serbia is stipulated in other erty and persons can be insured with a foreign laws and articles as an compulsory insurance. insurance company if insurance against that Law on Medical Products and Medical kind of risk is not conducted in the Republic Devices (“Offi cial Gazette of the Republic of of Serbia, and other property and persons pre- Serbia” No. 30/2010) provides thatthe sponsor scribed by the Government of the Republic of of a clinical trials Prior to the commencement Serbia [10]. of a clinical trial, must insure the persons sub- In new Serbian Insurance Law Law (“Offi cial jected to the clinical trials in case damages oc- Gazette of the Republic of Serbia” No. 139/2014) cur as to the health of those persons, where the 190 Volume 2 • Number 1 • January 2015 • HOPH Žagar ZA: Clinical Trial Insurance in Serbia which will apply from June 26, 2015 these stip- companies registered in Serbia (UNIQA insur- ulations are not basically modifi ed [11]. ance company Belgrade, AXA Insurance com- In 2006 the Government fo Serbia had is- pany Belgrade, Generali Insurance Company sued Decree on Property and Persons Th at Serbia, Wiener Stadtische Insurance Company May be Insured with a Foreign Insurance Belgrade etc..). Company (“Offi cial Gazette of the Republic of c) If the risk specifi ed in clinical trial policy Serbia” No. 47/2006). Th is Decree stipulates is over the self insured retention of domestic that Persons requesting an approval of a com- insurance company, than the risk over the self petent authority of the Republic of Serbia for insured retention can be placed in reinsurance clinical testing of medications and medica- abroad, through one of four reinsurance com- ments, and for placing medicaments of foreign panies in Serbia: Dunav Re, Generali Re Ser- producers in sale, in conformity with the law bia, Novi Sad Re and Wiener Re Serbia [13]. governing medications and medicaments, may However „fronting“ polices are against the take out insurance against liability for damage Srbian insurance Law (“Offi cial Gazette of sustained as a consequence of application of the Republic of Serbia” No. 55/2004, 70/2004, such medications or medicaments with a for- 61/2005, 61/2005–other Law, 85/2005–oth- eign insurance company, on condition that the er Law and 101/2007, 107/2009, 99/2011, insurance contract acknowledges the jurisdic- 119/2012 and 116/2013) which stiupulates: tion of domestic courts and other authorities - Th e self insured retention of the insurance to decide on damage claims [12]. Th is stipula- company is the amount of the risks undertaken tion never applied in praxis in Serbia due to by the contract, which the company it self keeps the prescribed condition that the insurance at all times, and which it can cover by its own contract acknowledges the jurisdiction of do- means [14] (the total limit of indemnity of mestic courts and other authorities to decide EUR 500.000 and even of EUR 1.000.000 with on damage claims.
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