Clinical Trial Insurance in Serbia A

Hospital Pharmacology. 2015;2(1):189-198 and theirassistantsta Centers inSerbiaperformingorcontrollingtheclinicaltrial,Principal Investigators Under theclinicaltrialliabilityinsurancecoverinsuredsare:Sponsor, Medical of Serbianinusrancecompaniesareissuingsuchpolices. Clinical Trial LiabilitypolicyissuedbytheSerbianinsurancecompany. Nowadays,few The Sponsorwillful practice). other Serbianauthoritiestodecideondamageclaims(thatneverhappendin the insurancecontractacknowledgesjurisdictionofSerbiandomesticcourtsand only exceptance,iswhentheforeignclinicaltrialliabilitypolicystipulatedthat by theinsurancecompanyestablishedinSerbiashallbedeemedasnullandvoid. The by theinsurancecompaniesestablishedinSerbia.Everypolicynotissued According toprovisionsofSerbianInsurancelawinsurancepoliceshavebeissued caused bytheclinicaltrial. vide theinsurancepolicycoveringpatient’s bodilyinjuryanddamagedhealth Prior thecommencementofclinicaltrialinSerbiaSponsorisobligedtopro- SUMMARY A MARFI-PE Insurance Broker Co. Ltd. Belgrade A Zlatko A.Žagar A Clinical Trial Insurance inSerbia cover thefollowing:non- If aninsuranceeventoccursthebene so fartoindemnifythepatientsincaseofinsuredevent. total suminsuredbetweenEUR500.000and1.000.000isconsideredassu insured forthetotalperiodofinsurancecover. According tocase-law inSerbiathe by theamountofsuminsuredperoccurrenceand/ortotal The amountofindemnitybytheinsurancecompanytobene alienation, psychicdamages,illnessesanddeathscausedbytheclinicaltrial. the insuredeventoccurredi.e.whenbodilyinjury, psychicdiseaseand The insurancecompanywillindemnifythebene of theinsurancecoverarepatientsand/ormemberstheirfamilies–inheritresses. claimant; costsnecessaryfortheeliminationof non- Keywords: year inwhichaclaimswascaused. time baredfor the timebarperiodcommencesfromdayofawarnes, butinanycaseaclaimis date de calendar yearinwhichaclaimswascaused.Iftheinterested partyprovesthatuntil are timebaredforthreeyears,reckoningfromthe Serbian LawonObligationsstipulatesthatclaimsof thepolicyholderorthirdparty of theclaimant;costslitigation. E-mail: MARFI-PE Iinsurance BrokerCo.Ltd.Belgrade,5 Director Zlatko A. Žagar, LLB Corresponding author: zlatko.zagar@mar fi ned inaboveparagraphitwasnotawarethatinsuredeventhadhappened, clinicaltrials,research,investigator, patientsinsurance,regulations fi ve years,reckoningfromthe fi fi -pe.co.rs ll thisobligationstipulatedinSerbian law whenprovidesthe ff performingorcontrollingtheclinicaltrial. The bene fi nancial lossesoftheclaimant; /7 Budimska,11000 Belgrade,Serbia fi ts providedbytheinsurancecompanyshall fi rst dayuponexpirationofthecalendar fi ciary mentionedinthepolicywhen fi rst dayuponexpirationofthe fi fi nancial and nancial nancial bene UDC: 616-071:368.9.06(497.11) doi:10.5937/hpimj1501189Z ISSN 2334-9492(Online) fi ciaries islimited fi nancial losses nancial fi ts lostbythe fi ciaries ffi cient

189 Education article

INTRODUCTION damage is caused by the clinical trial of medicinal 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. Foreign insurance compa- lower limits per occurrence are within the self nies are not willing to accept the jurisdiction insured retention of all better insurance com- of Serbian courts as part of their insurance po- panies in Serbia) and lices and insurance conditions. - Authorized persons in an insurance company, Th erefore, within the territory of Serbia, insurance brokerage company, insurance agen- Clinical Trial Insurance polices are issuing by cies, agencies providing other insurance services, domestic insurance companies registered at enterprises or other legal entities with special authorities in Republic of Serbia. purpose departments for providing other insurance services, as well as insurance agents, who Possibility of cooperation with foreign insur- on the occasion of risk and claims assessment ance companies draft a false assessment and statement shall be sentenced for a criminal off ense to a fi ne or im- Th ere are few possibilities for foreign insur- prisonment of up to three years [15]. ance companies to take part in covering the Th e similar stipulations are in new Serbian clinical trial risk in Serbia. Insurance Law Law (“Offi cial Gazette of the a) Generally, the clinical trial insurance policy Republic of Serbia” No. 139/2014) which will issued by the insurance company not regis- apply from June 26, 2015 [16]. tered in Serbia is null and void, except when Furthermore, insurance companies reg- in the policy is stipulated that the insurance istered in Serbia must apply only their own contract acknowledges the jurisdiction of do- insurance conditions and tariff s previously mestic courts and other authorities to decide adopted by their Board and thereaft er submit- on damage claims, as provided for in Decree ted within 15 days to National Bank of Serbia on Property and Persons Th at May be In- attached with positive actuarial opinion [17]. sured with a Foreign Insurance Company Th e National Bank of Serbia is entitled to with- (“Offi cial Gazette of the Republic of Serbia” No. draw from an insurance company the business 47/2006). license if the insurance company fails to act in b) Th e foreign insurance company can form accordance with these stipulations and apply and establish an insurance company in Ser- not legally adopted insurance conditions and bia. Th at company will be domestic insurance tariff s and/or if not previously submitted their company and can lagally issue clinical trial po- insurance conditions and tariff s attached with lices. Nowadays, there are few such insurance actuarial positive opinion to National Bank of www.hophonline.org 191 Hospital Pharmacology. 2015; 2(1):189-198

Serbia within 15 days from the adoption by ical researsch organization (CRO), as well. the Board [18]. Aside of stipulations in Serbian Insurance 3. Insurance Events Law which do not allow so called „fronting“ polices, the „fronting“ polices are not recom- Insurance events are: mended for implementation in clinical trial in- a) Death or permanent injury to health of the surances in Serbia, as well. One of the reasons Trial Subject caused by the investigational is that the reinsurance conditions submitted medical product under trial by the foreign reinsurer to domestic company b) Death or permanent injury to health of the can be contradictory to the imperative stipula- Trial Subject, caused directly by his/her per- tions of the Serbian positive law. For example, ticipation in the clinical trial [24]. if the reinsurance contract provides „claims made“ insurance cover such stipulation will be 4. Insurance cover considered as null and void due to imperative stipulations of domestic Law on Obligation If an insurance event occurs the benefi ts pro- which provides „claims occurrence“ insurance vided by the Insurance Company shall cover cover [19]. the following: - non-fi nancial losses of the claimant; 2. Insurance policy covering clinical trial as - fi nancial benefi ts lost by the claimant; requiering in Serbian Law - costs necessary for the elimination of the non-fi nancial and fi nancial losses of the claim- Insurance policy required by the Serbian law is ant; world known Clinical Trial Liability policy. - costs of litigation and legal defence approved With the inception of the Clinical Trial Li- by the Insurance Company in advance [25]. ability policy the Insurer (insurance company Generally Clinical Trial Liability Insurance registered in Serbia) is covering the compen- policy is covering rights for indemnity as spec- sation obligation of the Insured in respect of ifi ed in Serbian Law on Obligation [26]. losses caused to the Trial Subject (Patients) in the course of clinical trials performed or spon- 5. Exclusions from the insurance cover sored by the Insured, for which the Insured is liable and obliged to pay compensation ac- Th e indemnifi cation obligation under the cording to the legal rules of the Republic of clinical trial liability insurance generally is not Serbia [20]. covering the following: Insured is the institution or company spon- - any claims arising from circumstance(s) or soring or performing the clinical trial, whose occurrence(s) which has been notifi ed under name is indicated in the policy [21]. any Policy or Certifi cate of Insurance attach- If the Insured in the policy only sponsors ing prior to the inception of this Policy, such trial, but the trial is performed by other - losses arising from the fact that the inves- medical institution(s), for the purpose of this tigational medical product did not meet the insurance than the medical institutions, em- expectations or did not produce the expected ployees of the institution(s) (principal investi- benefi cial results, gators and his/her assistant staff ) performing - in the cases when the study includes the trial or controlling the trial, shall be deemed to be (testing) of a medical product, no indemnifi - co-insureds [22]. cation is paid to the Trial Subject who did not Trial Subject is an individual patient or receive such during the trial, except non-patient volunteer who aft er signing the a) if the loss arises from the fact that in the Informed Consent participates in the clinical interest of the trial, other medical products or trial [23]. treatments that otherwise would be used for Patient and non-patient volunteer are not the mitigation of the given illness or condition, insureds. Th ey are benefi ciaries of the insur- were withheld, or ance policy. Insureds are: sponsor, medi- b) if the placebo having been given to the Trial cal institutions in Serbia, employees of those Subject makes the refusal of the indemnifi ca- institution/s (principal investigators and theirs tion to be unreasonable, assistant staff ) performing and controlling the - claims directly or indirectly caused by or clinical trial and sometimes the isnured is clin- contributed to by or arising from ionising ra-

192 Volume 2 • Number 1 • January 2015 • HOPH Žagar ZA: Clinical Trial Insurance in Serbia diation or radioactive contamination by radio- ent court practice in Serbia, Limit of Indem- activity from any nuclear fuel or any nuclear nity – Sum Insured over EUR 2.000.000 is not waste from the combustion of any nuclear necessary. fuel; or from the radioactive, toxic, explosive or other hazardous properties of any explo- 7. Time Bar Period for Insurance Contract sive nuclear assembly or nuclear component thereof, Serbian Law on Obligation stipulates that - any losses caused by or in consequence of: Claims of the policy holder, or third party in a) war, invasion, acts of foreign enemies, hos- the case of life insurance contract, are time tilities or warlike events (whether war be de- bared for fi ve, and for other insurance con- clared or not), civil war, tracts for three years, reckoning from the fi rst b) permanent or temporary seizure, resulting day upon expiration of the calendar year in from confi scation, military appropriation or which a claims was caused [28]. requisition on the order of a legal authority, If the interested party proves that until date c) riot, strike, rebellion, separatist action, mili- defi ned in above paragraph it was not aware tary or civil appraisal, insurrection, counter- that insured event had happened, the time bar revolution, revolution, military or usurped period commences from the day of awarnes, power, martial law or any other event or rea- but in any case a claim is time bared, for the son the declaration of which entails the intro- life insurance contract for ten, and for other duction of martial law, insurance contracts for fi ve years, from the day d) terrorist action committed by any organisa- defi ned in above paragraph [29]. tion or any person or persons acting on behalf Claim of the minor without legal represen- or in connection with such organisations. tative and other person without representative, - If the Insured (the Policyholder) failed to cannot be time barred before expiration of two comply with his/her reporting obligation out- years from the time when that persons became lined in the policy, and therefore substantial completely legally capable or from the time circumstances became concealed.In the case they obtained representative [30]. of breach of the reporting and change report- Th e above are imperative stipulations and ing obligation determined in the policy, the any modifi cation and/or cancellation of them liability of the Insurance Company shall not in the policy or in the policy wording is null arise, unless it is proved that the circumstance and void. so concealed or not reported was known to the Insurance Company at the conclusion of the 8. Rules of compensation and amount of in- contract or they did not interfere with the oc- demnifi cation currence of the insurance event [27]. Clinical Trial Liability Insurance conditions 6. Limit of Indemnity – Sum Insured stipulates that: - Th e Insurer Company shall indemnify the Serbian law does not prescribe the Limit of In- benefi ciary for losses up to the limit amount demnity – Sum Insured of the required insur- for any one event and for annual aggregate ance cover. (limit of indemnity) stated in the Schedule However, in practice, it is required by local forming part of the contract. Ethic Committees in each Medical Centre in - All reimbursements shall be paid by the Un- Serbia and by the Central Committee at Medi- derwriter in a lump sum. cine and Medical Devices Agency of Serbia - Th e amount of compensation payable shall that the minimum Limit of Indemnity – Sum be appropriate to the nature, severity and per- Insured is EUR 500.000 for Phase III and IV of sistence of the injury. It should be assessed the clinical trial and bioequivalence Phase and with reference to the measure and quantum of EUR 1.000.000 for Phases I and II of the clini- damages that would have been awarded by the cal trail. If the Limit of Liability – Sum Insured courts of the country where Trial took place is lower, than the policy can be rejected by the at the date on which the compensation is as- committee in charge in Serbia. sessed for a substantially similar injury. Th ere is no need for arrangement of much - Compensation shall not be denied or abated higher Limit of Indemnity – Sum Insured for by reason of any participation of a third party clinical trial insurance in Serbia. Due to pres- in causing the damage for which such third www.hophonline.org 193 Hospital Pharmacology. 2015; 2(1):189-198

party can be made liable (joint liability), but lices in Serbia are concluded and issued us- following the settlement of the claim the Trial ing engagements of the insurance brokers. Subject’s rights against such third party shall Activities of the insurance bokers in Serbia be subrogated to the Insurer. are stipulated in Serbian Insurance Law (“Of- - Th e amount of the compensation shall be fi cial Gazette of the Republic of Serbia” No. paid by the Insurer to the Trial Subject within 55/2004, 70/2004, 61/2005, 61/2005–other Law, fourteen days from the date of the receipt of 85/2005–other Law and 101/2007, 107/2009, the loss occurence notifi cation. If some pe- 99/2011, 119/2012 and 116/2013) still apply- riod of time is necessary for establishing the ing [33] and in new Serbian Insurance Law existance of the obligation of the Insurer and (“Offi cial Gazette of the Republic of Serbia” No. for the amount of such obligation, the above 139/2014) which will apply from June 26, 2015 mentioned period of fourteen days shall com- [34]. mence from the date when such obligation Insurance brokerage activities include activ- and its amount is established. If the amount of ities related to connecting the insured and/or obligation of the Insurer would not have been policy holder with an insurance company, in established within the above specifi ed period order to negotiate the conclusion of an insur- of fourteen days, than the Insurance company ance contract, based on the order of the insur- must, on the request of the benefi ciary/Trial ance company established in compliance with Subject, pay the amount of the uncontested the provisions of this Law or based on the or- part of its obligation as the advance payment. der of the insured, and/or policyholder [35]. - In connection with any claims against the Insurance brokerage activities, as the sole Insured, the Insurer may at any time pay the type of activity, are conducted by an insurance Insured the amount equalling the Limit of In- brokerage company licensed by the National demnity or any lesser amount for which such Bank of Serbia to carry out those activities claims can be settled and thereupon the Insur- [36]. er shall relinquish the control of such claims Th erefore, foreign insurance brokers not and be under no further liability in connection registered in Serbia and without a license ob- therewith except for the costs and expenses tained from National Bank of Serbia can not that the Insurer has already agreed to bear in conduct their brokerage activities in Serbia. respect of matters, prior to the date of such Th e task of the insurance broker is to: payment [31]. - provide expertise and advise to the Client/ Insured in respect of required and necessary 9. Deductibles insurance, assessment of the risk, the scope of the cover and insurance conditions; Deductibles are oft en stipulated in Clinical - obtain the insurance off ers from one or more Trial Liability polices in Serbia. However, if de- of the insurance companies and negotiate with ductibles are higher than 20% minumum EUR them to obtain the best possible insurance 2.000 per loss, than such policy can be rejected conditions and accaptable (as lower as pos- by the local authorities (Ethic Committees). sible) insurance premium; Th erefore, it would be much better if deduct- - present and explain to the Client/Insured all ibles are not part of the policy or if the insur- obtained insurance off ers and suggest the ac- ance cover is concluded with certain deduct- ceptance of the best insurance off er/insurance ibles, than it is better to stipulate in the policy company amongst them acceptable for local that the Insurer shall compensate the benefi - ethic committees and central Agency; ciary / Trial Subject in whole amount applying - aft er the issuance of the policy provide all no deductibles and in such case the Insured is necessary advices and assistance to the Client/ obliged to compensate the Insurer the part of Insured and in case of any loss off or damage the loss od damage up to the amount of so paid assist and advise the Insured in respect of as- deductible/s [32]. sessment of the damage and submission of the claim [37]. 10. Insurance brokers – their position and All services provided by the insurance bro- importance in arranging Clinical Trial Po- ker to the Insured are free of charge for the lices in Serbia Insured. Th e insured who engaged the insurance broker has no obligation to pay to the Many of Clinical Trial Liability Insurance po- insurance broker any fee, commission, charges

194 Volume 2 • Number 1 • January 2015 • HOPH Žagar ZA: Clinical Trial Insurance in Serbia or expanses neither if the insurance contract REFERENCES is concluded nor if the negotiations failed and the policy is not issued. 1. Article 6. paragraph 1. of Serbian Insurance Law (“Oﬃ cial Gazette of the Republic of Serbia” In Serbia there are few insurance brokers No. 55/2004, 70/2004, 61/2005, 61/2005–other familiar with clinical trial liabiulity insurances Law, 85/2005–other Law and 101/2007, 107/2009, and it is recommended to sponsors and other 99/2011, 119/2012 and 116/2013), insureds to engage one of them. http://www.nbs.rs/internet/english/20/zakoni. html

CONCLUSION 2. Article 6. paragraph 2. of Serbian Insurance Law (“Offi cial Gazette of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005–other Clinical trial insurance is compulsory insur- Law, 85/2005–other Law and 101/2007, 107/2009, ance in Serbia. 99/2011, 119/2012 and 116/2013), Insurance policy required by the Serbian law http://www.nbs.rs/internet/english/20/zakoni. is world known Clinical Trial Liability policy. html Th e policy has to be issued by the insurance 3. Article 4. of the new Serbian Insurance Law company registered in Serbia, except if in the (“Offi cial Gazette of the Republic of Serbia” No. foreign insurance policy is specifi ed that the 139/2014), insurance contract acknowledges the jurisdic- http://www.nbs.rs/internet/english/20/zakoni. html tion of Serbian domestic courts and other Ser- bian authorities to decide on damage claims. 4. Article 72. of Law on Medical Products and Med- However, foreign insurance companies are not ical Devices (“Offi cial Gazette of the Republic of willing to accept the jurisdiction of Serbian Serbia” No. 30/2010), http://www.alims.gov.rs/eng/regulations/law-on- courts and other Serbian authorities as part of medicines-and-medical-devices/ their insurance polices and insurance conditions. 5. Article 25. paragraph 9. of Law on Patients’ Th ere are few insurance companies in Serbia rights (“Offi cial Gazette of the Republic of Serbia” No. 45/2013) which are issuing clinical trial insurance polices in accordance with Serbian Law. Fronting 6. Article 6. paragraph 1. point 18 of Ordinance on polices are not allowed in Serbia and generally Content of Claims or Documentaion for Approval not recommended, as well. of Clinical Trials of Medicaments and Medical De- vices, as well as on the Procedure of Clinical Tri- Limit of Indemnity – Sum Insured in Ser- als of Medicaments and Medical Devices (“Offi cial bia is still very low comparing to limits in West Gazette of the Republic of Serbia” No. 64/2011 and European countries and in USA. In practice, it No. 91/2013), is required by local Ethic Committees in each http://www.alims.gov.rs/eng/regulations/rules- for-medicinal-products/ Medical Centre in Serbia and by the Central Committee at Medicine and Medical Devices 7. Article 26. paragraph 1. point 4 of Ordinance on Agency of Serbia that the minimum Limit Content of Claims or Documentaion for Approval of Indemnity – Sum Insured is EUR 500.000 of Clinical Trials of Medicaments and Medical De- vices, as well as on the Procedure of Clinical Tri- for Phase III and IV of the clinical trial and als of Medicaments and Medical Devices (“Offi cial bioequivalence Phase and EUR 1.000.000 for Gazette of the Republic of Serbia” No. 64/2011 and Phases I and II of the clinical trail. Otherwise, No. 91/2013) the policy can be rejected and the trial post- 8. Article 7. paragraph 1. of Serbian Insurance poned. Law (“Offi cial Gazette of the Republic of Serbia” It is recommended to Sponsors and other No. 55/2004, 70/2004, 61/2005, 61/2005–other Insureds to engage the local insurance broker Law, 85/2005–other Law and 101/2007, 107/2009, to arrange clinical trial liability insurance for 99/2011, 119/2012 and 116/2013), http://www.nbs.rs/internet/english/20/zakoni. them for the particular trial. Th ere are few html Serbian insurance brokers which can fi nalize whole procedure and obtained proper Clinical 9. Article 7. paragraph 2. of Serbian Insurance Trial Liability policy in Serbian and in English Law (“Offi cial Gazette of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005–other language within 2-5 days. Law, 85/2005–other Law and 101/2007, 107/2009, 99/2011, 119/2012 and 116/2013), http://www.nbs.rs/internet/english/20/zakoni. html

10. Article 7. paragraph 3. of Serbian Insurance www.hophonline.org 195 Hospital Pharmacology. 2015; 2(1):189-198

Law (“Offi cial Gazette of the Republic of Serbia” Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005– No. 55/2004, 70/2004, 61/2005, 61/2005–other other Law, 85/2005–other Law and 101/2007, Law, 85/2005–other Law and 101/2007, 107/2009, 107/2009, 99/2011, 119/2012 and 116/2013) and 99/2011, 119/2012 and 116/2013), Article 214. paragraph 1. point 16 of the new Ser- http://www.nbs.rs/internet/english/20/zakoni. bian Insurance Law (“Offi cial Gazette of the Re- html public of Serbia” No. 139/2014), http://www.nbs.rs/internet/english/20/zakoni. 11. Article 20. paragraph 1. and Article 3. of the html new Serbian Insurance Law (“Offi cial Gazette of the Republic of Serbia” No. 139/2014), 19. Articles 376 - 380 of Law on Obligations Pub- http://www.nbs.rs/internet/english/20/zakoni. lished in the Službeni list SFRJ, No. 29/78 of 26 May html 1978; Amendments in Nos. 39/85 of 28 July 1985, 45/89 of 28 July 1989 (YCC) and 57/89 of 29 Sep- 12. Article 2. of Decree on Property and Persons tember 1989; Final amendments in the Službeni list That May be Insured with a Foreign Insurance SRJ, No. 31/93 of 18 June 1993, Company (“Offi cial Gazette of the Republic of Ser- http://www.mpravde.gov.rs/fi les/The%20Law%20 bia” No. 47/2006), of%20Contract%20and%20Torts_180411.pdf> http://www.nbs.rs/internet/english/20/osg/in- dex.html 20. Article I. of Clinical Trial Liability Insurance conditions issued by UNIQA Non-Life Insurance Compa- 13. Article 15. paragraph 1., 2., 3. and 4. of Serbian ny Belgrade on March 8,2012 Insurance Law (“Offi cial Gazette of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005– 21. Defi nitions in Clinical Trial Liability Insurance other Law, 85/2005–other Law and 101/2007, conditions issued by Energoprojket Garant Non- 107/2009, 99/2011, 119/2012 and 116/2013) and Life Insurance Company Belgrade on November 23, Article 20. paragraph 1., Article 3 paragraph 2. and 2007 Article 7. paragraph 1., 2., 3., 4. and 5. of the new Serbian Insurance Law (“Offi cial Gazette of the 22. Defi nitions in Clinical Trial Liability Insurance Republic of Serbia” No. 139/2014), conditions issued by Energoprojket Garant Non- http://www.nbs.rs/internet/english/20/zakoni. Life Insurance Company Belgrade on November 23, html 2007

14. Article 15. paragraph 2. of Serbian Insurance 23. Defi nitions in Clinical Trial Liability Insurance Law (“Offi cial Gazette of the Republic of Serbia” conditions issued by Energoprojket Garant Non- No. 55/2004, 70/2004, 61/2005, 61/2005–other Life Insurance Company Belgrade on November 23, Law, 85/2005–other Law and 101/2007, 107/2009, 2007 99/2011, 119/2012 and 116/2013), http://www.nbs.rs/internet/english/20/zakoni. 24. Article II. of Clinical Trial Liability Insurance html conditions issued by UNIQA Non-Life Insurance Com- pany Belgrade on March 8, 2012 15. Article 224. of Serbian Insurance Law (“Offi cial Gazette of the Republic of Serbia” No. 55/2004, 25. Article IV. of Clinical Trial Liability Insurance 70/2004, 61/2005, 61/2005–other Law, 85/2005– conditions issued by UNIQA Non-Life Insurance Com- other Law and 101/2007, 107/2009, 99/2011, pany Belgrade on March 8, 2012 119/2012 and 116/2013), http://www.nbs.rs/internet/english/20/zakoni. 26. Articles 185-205 of Law on Obligations Pub- html lished in the Službeni list SFRJ, No. 29/78 of 26 May 1978; Amendments in Nos. 39/85 of 28 July 1985, 16. Article 7. paragraph 2. and Article 258. of the 45/89 of 28 July 1989 (YCC) and 57/89 of 29 Sep- new Serbian Insurance Law (“Offi cial Gazette of tember 1989; Final amendments in the Službeni list the Republic of Serbia” No. 139/2014), SRJ, No. 31/93 of 18 June 1993, http://www.nbs.rs/internet/english/20/zakoni. http://www.mpravde.gov.rs/fi les/The%20Law%20 html of%20Contract%20and%20Torts_180411.pdf>

17. Article 58. paragraph 1. and paragraph 2. point 27. Articles V and VI of Clinical Trial Liability Insur- 1 and Article 156. paragraph 1. point 6 and para- ance conditions issued by UNIQA Non-Life Insurance graph 2. of Serbian Insurance Law (“Offi cial Gazette Company Belgrade on March 8, 2012 of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005–other Law, 85/2005–other Law 28. Article 380 paragraph 1. of Law on Obligations and 101/2007, 107/2009, 99/2011, 119/2012 and Published in the Službeni list SFRJ, No. 29/78 of 116/2013) and Article 67. paragraph 1. and Para- 26 May 1978; Amendments in Nos. 39/85 of 28 July graph 2. point 1 and Article 177. paragraph 1. Point 1985, 45/89 of 28 July 1989 (YCC) and 57/89 of 29 6 of the new Serbian Insurance Law (“Offi cial Ga- September 1989; Final amendments in the Službeni zette of the Republic of Serbia” No. 139/2014), list SRJ, No. 31/93 of 18 June 1993, http://www.nbs.rs/internet/english/20/zakoni. http://www.mpravde.gov.rs/fi les/The%20Law%20 html of%20Contract%20and%20Torts_180411.pdf>

18. Article 174. paragraph 1. point 12 of Serbian 29. Article 380 paragraph 2. of Law on Obligations Insurance Law (“Oﬃ cial Gazette of the Republic of Published in the Službeni list SFRJ, No. 29/78 of

196 Volume 2 • Number 1 • January 2015 • HOPH Žagar ZA: Clinical Trial Insurance in Serbia

26 May 1978; Amendments in Nos. 39/85 of 28 July 1985, 45/89 of 28 July 1989 (YCC) and 57/89 of 29 September 1989; Final amendments in the Službeni list SRJ, No. 31/93 of 18 June 1993, http://www.mpravde.gov.rs/ﬁ les/The%20Law%20 of%20Contract%20and%20Torts_180411.pdf>

30. Article 385. of Law on Obligations Published in the Službeni list SFRJ, No. 29/78 of 26 May 1978; Amendments in Nos. 39/85 of 28 July 1985, 45/89 of 28 July 1989 (YCC) and 57/89 of 29 September 1989; Final amendments in the Službeni list SRJ, No. 31/93 of 18 June 1993, http://www.mpravde.gov.rs/ﬁ les/The%20Law%20 of%20Contract%20and%20Torts_180411.pdf>

31. Article X of Clinical Trial Liability Insurance conditions issued byEnergoprojket Garant Non-Life In- surance Company Belgrade on November 23 ,2007

32. Article XI of Clinical Trial Liability Insurance conditions issued by UNIQA Non-Life Insurance Company Belgrade on March 8, 2012

33. Articles 72-86 of Serbian Insurance Law (“Of- ﬁ cial Gazette of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005–other Law, 85/2005–other Law and 101/2007, 107/2009, 99/2011, 119/2012 and 116/2013), http://www.nbs.rs/internet/english/20/zakoni. html

34. Articles 85-96 of the new Serbian Insurance Law (“Oﬃ cial Gazette of the Republic of Serbia” No. 139/2014), http://www.nbs.rs/internet/english/20/zakoni. html

35. Article 72 of Serbian Insurance Law (“Oﬃ cial Gazette of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005–other Law, 85/2005– other Law and 101/2007, 107/2009, 99/2011, 119/2012 and 116/2013), http://www.nbs.rs/internet/english/20/zakoni. html

36. Article 73. paragraph 1. of Serbian Insurance Law (“Oﬃ cial Gazette of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005–other Law, 85/2005–other Law and 101/2007, 107/2009, 99/2011, 119/2012 and 116/2013), http://www.nbs.rs/internet/english/20/zakoni. html

37. Article 84. of Serbian Insurance Law (“Oﬃ cial Gazette of the Republic of Serbia” No. 55/2004, 70/2004, 61/2005, 61/2005–other Law, 85/2005– other Law and 101/2007, 107/2009, 99/2011, 119/2012 and 116/2013) and Article 94. of the new Serbian Insurance Law (“Oﬃ cial Gazette of the Republic of Serbia” No. 139/2014), http://www.nbs.rs/internet/english/20/zakoni. html

www.hophonline.org 197 Hospital Pharmacology. 2015; 2(1):189-198

Osiguranje kliničkih ispitivanja u Srbiji A Zlatko A. Žagar A MARFI-PE Insurance Broker Co. Ltd. Beograd, Srbija

KRATAK SADRŽAJ Pre početka kliničkih ispitivanja u Srbiji zakonska je obaveza sponzora da obezbedi polisu osiguranja koja bi pacijentima koji se podvrgavaju kliničkim ispitivanjima obez- bedila 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 osiguanje 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 sponsor, zdravstvene ustanove gde se vrše klinička ispitivanja, glavni istraživači koji sprovode klinička istraživanja i njihovi asis- tenti. Korisnici naknade iz osigurnja 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 dodje 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 Kompani- ja treba da pokriva sledeće: materijalne i nematerijalne štete/gubitke oštećenoga, tj. korisnika osiguranja; izgubljenu ﬁ nansijsku 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: klinička ispitivanja, osiguranje pacijenata, regulativa, istraživač

Received: December 1, 2014 Accepted: January 15, 2015

198 Volume 2 • Number 1 • January 2015 • HOPH