Comprehensive Webinar on Clinical Trial Insurance and Compensation in India

1. Webinar on Clinical Trial Insurance in Current Perspective of Compensation Requirement in India Mr. Puneet Chandra Dr.ManojKarwa

2. Content • Compensation for SAE related injury or death • Key Stakeholders • CT Insurance • Who Needs CT Insurance • Types of Risks • Types of Claims • Coverage • Definition • Exclusion • Role of An Insurance Broker • FAQ’s Webinar On Clinical Trial Insurance

3. Compensation Formula For SAE of Death Compensation Formula = B x F x R 99.37 • Computing the 3 factors viz. a) Age b) Risk and c) base amount • B = Base amount (i.e. 8 lacs) • F = Factor depending on the age of the subject (based on Workmen Compensation Act) • R = Risk Factor depending on the seriousness and severity of the disease -scale of 0.5 to 4 • However, in case of patients whose expected mortality is 90 % or more within 30 days, a fixed amount of Rs. 2 lacs should be given. • Compensation amount will vary from a minimum of Rs.4 lacs to a maximum of Rs.73.60 lacs depending on the age of the deceased and the risk factor. Webinar On Clinical Trial Insurance

4. Compensation For SAE of Injury Considering the definition of SAE, the following four sequelae other than death are possible in a clinical trial subject, in which the subject shall be entitled for compensation in case the SAE is related to clinical trial. • A Permanent Disability • Congenital Anomaly or Birth Defect • SAE causing life-threatening Disease or • Reversible SAE in case it is resolved. Webinar On Clinical Trial Insurance

5. Compensation For Injury • A Permanent Disability • 100% permanent disability to a subject may not be considered equivalent to the death of the subject • Quantum of compensation in case of 100% disability should be 80% of the compensation of death of the subject • Quantum of compensation for less than 100% disability C= (Dx80xC)/100X100 • D= Percentage disability the subject has suffered. • C= Quantum of Compensation which would have been due for payment to the subject’s nominee(s) in case of death of the subject. Webinar On Clinical Trial Insurance

6. Compensation For Injury • Congenital Anomaly or Birth Defect: Following situations may arise due to congenital anomaly or birth defect. • Still birth • Early death due to anomaly • For a & b the quantum of compensation such SAE should be half of the base amount for SAE resulting into death = INR 400,000 (Rupees Four Lakhs) • No death but deformity which can be fully corrected through appropriate intervention • Permanent Disability (mental or physical) • For c & d: INR 400,000 ((Rupees Four Lakhs)) + Medical Management as long as required Webinar On Clinical Trial Insurance

7. Compensation For Injury • SAE causing life-threatening Diseasedisease Compensation = N x W • N= Number of days for which the trial subject remained under life-threatening situation requiring medical care, irrespective of number of days of hospitalization • Reversible SAE in case it is resolved. • Compensation per day of hospitalization in such case should be double the minimum wage Compensation = 2 x W x N • W=Minimum wage per day of the unskilled worker (in Delhi) Webinar On Clinical Trial Insurance

8. Key Stakeholders • Institutions • Investigators • Contract research Organizations (CROs) • Sponsors • Institutional review boards (IRBs) / ethics committees (ECs), and • Trial Participants Webinar On Clinical Trial Insurance

9. CT Insurance Even with excellent protocol design and thorough preclinical research, exposure to an investigational product in a clinical trial presents: • Bodily Injury risk to participants • Through legal proceedings & judgments, financial and reputational risk to all trial stakeholders. Clinical trial insurance can mitigate and transfer such associated, unavoidable risks of a trial through a well-designed insurance program. This kind of insurance basically covers legal liability arising out of lack of care, negligence resulting in injury or death of the subject. Webinar On Clinical Trial Insurance

10. Who Needs CT Insurance • Research companies • Clinical trial service companies, including clinical trial facilitators • Medical device manufacturers • Pharmaceutical manufacturers • Biotechnology researchers and developers • Contract research organizations Webinar On Clinical Trial Insurance

11. Types of Risks • Failure to perform as per the contract • Failure of proper monitoring • Failure to report negative information • Failure to provide adequate information • Defective drug supplied by the manufacturer • Fault in Study Protocol • Negligent act of investigator or the medical staff • Surrounding conditions of the hospital / medical center Webinar On Clinical Trial Insurance

12. Claims Comprising Of Compensation or Damages Claimants costs and expenses Cost of medical care Economic loss Pain & Suffering Loss of earning Cost of rehabilitation Legal defense cost Webinar On Clinical Trial Insurance

13. Coverage • Who is Covered? • Director or Partner / Sponsor of the Insured • Employees of the Insured including Medical Staff / Doctors • Any past employee who acted for the Insured • Any sub-contractor doctor consultant physician hospital or contract research organization or nurse • Ethics Committee or its members that has approved a Trial • What is Covered? • Compensation for injury, disease, mental shock & death to trial participant • Medical aid to the injured study subject • Damages awarded by court Webinar On Clinical Trial Insurance

14. Coverage Trigger Webinar On Clinical Trial Insurance

15. Professional Indemnity Extension “……. pay on behalf of the InsuredLoss arising solely out of Professional Services resulting from any Claim first made against such Insured during the Policy Period …” Webinar On Clinical Trial Insurance

16. Definitions • Bodily Injury shall mean personal injury sickness disease or death and shall include mental injury mental anguish shock • Defence Costs shall mean all the costs and expenses (including any fees or disbursements of any Independent Lawyer) incurred by or on behalf of the Insured with the written consent of the Company in relation to any Occurrences which may be the subject of indemnity under this Policy • Claim shall mean a written demand made against the Insured for money or services in respect of Bodily Injury insured by this Policy • Research Subject shall mean any person participating in a Trial including their dependents heirs executors administrators and legal representatives Webinar On Clinical Trial Insurance

17. Definitions Contd… • Loss means Defence Costs and the total amount covered under this policy which the Insured becomes legally obligated to pay on account of any covered Claim including, but not limited to: (a) awards of damages; (b) judgments; (c) sums payable due to any settlements agreed to by the Company in accordance with section 7; and (d) awards of claimant’s costs. • Wrongful Act means any error, misstatement, misleading statement, act, omission, neglect, or breach of duty committed, attempted or allegedly committed or attempted, by an Insured Organsiation or an Insured Person, individually or otherwise, on behalf of the Insured Organisation, solely in the performance of ProfessionalServices as stated in Item 10 of the Schedule. Webinar On Clinical Trial Insurance

18. Exclusions • Circumstances of which you were aware prior to the inception of this Policy • Violation of study protocol and GCP guidelines • Occurrence happening prior to the Retroactive Date • Creutzfeldt-Jakob Disease • Consequence of Guarantee/ Warrantee • Consequence of Financial Impairment • Non-monetary relief or for enforcement of any order for, grant of or agreement to provide non-monetary relief • Loss arising out of asbestiform talc, asbestos, diethylstilbestrol (DES), formaldehyde, or acquired immune deficiency syndrome (AIDS) Webinar On Clinical Trial Insurance

19. Exclusions Contd… • Contractual Liability • Patents and Trade Secret • War, Terrorism • Deliberate, Malicious, Dishonest or Criminal act • Nuclear radiations • Fines & Penalties Webinar On Clinical Trial Insurance

20. Role of an Insurance Broker • An insurance broker is an independent entity that has been authorized by the government thru an appellate authority for conducting un-biased advisory role in the insurance industry. • A broker when hired by the client represents them and act as their insurance outsourced arm and takes all responsibility of sourcing, negotiating with the market including educating the client of all the nitty-gritties of an insurance contract. • The role of an insurance broker amongst many other encompass: • Understanding the requirements of the client. • Correlate & match the requirements with the contracts available in the market. • Explain the contract word-per-word to the client • Approach the market and negotiate the most effective proposal for the client basis their requirements. Webinar On Clinical Trial Insurance

21. FAQ’s • How much time insurer generally take once sponsor receive notice from DCGI? • Provided that all details are given to the insurer, it takes 2-3 days for the Insurer to provide insurance cover note to the client. • Is investigator negligence covered in insurance? • Yes it is covered under the Professional Indemnity extension of the insurance contract. Discuss it with your broker in detail to meet your requirements and risk. Webinar On Clinical Trial Insurance

22. FAQ’s • How to decide a right insurance cover for a trial. • Insurance cover limits maybe decided by depending upon the phase of the trial; no. of subjects and the contractual obligation of the sponsor. Though it is virtually impossible to cover each and every subject by applying a multiplier to reach to a per subject insurance cover. Mostly market standards are followed by the CROs and Sponsors for arriving at the sum assured limit. An insurance broker helps understand the client the prevailing market norms. Webinar On Clinical Trial Insurance

23. FAQ’s • Are all phases of trials are covered and how the risk vs phases vs premium varies • Yes, all phases can be covered. The premium varies depending on the phase. Phase III & Phase IV, BE studies have lower premiums vis-à-vis Phase I & II. • What about the blanket insurance of covering multiple trial vs individual trial insurance - benefit and risk. • Yes, It Can Be Arranged. Discuss with your insurance broker. Webinar On Clinical Trial Insurance

24. FAQ’s • Is it mandatory to have CT Insurance ? • The regulator has laid down the compensation guidelines which may hold key stakeholders responsible for their respective liabilities. CT Insurance is part of distribution your risk to the insurer. • Documents required by the insurance companies for issue an insurance policy. • Protocol Copy • Consent Form Draft • Proposal Form • Premium Cheque Webinar On Clinical Trial Insurance

25. FAQ’s • One trial one policy? Yes it can be done. • Many trials one policy? Yes it can be done. • Trial started last year, policy required now? Yes it can be done. • Trials at various locations? Yes it can be done. • Other requirements – We can discuss. Webinar On Clinical Trial Insurance

26. WEBINAR CONDUCTED BY Dr. Manoj Karwa AURIGA RESEARCH manoj.karwa@aurigaresearch.com www.aurigaresearch.com Mr. Puneet Chandra SIVANA INSURANCE BROKERS PRIVATE LIMITED puneet.chandra@sivanainsurance.com www.sivanainsurance.com Webinar On Clinical Trial Insurance

27. Thank You for Your Attention www.aurigaresearch.com www.sivanainsurance.com