INSURANCE FOR CLINICAL TRIALS

Transcription

1 INSURANCE FOR CLINICAL TRIALS Can we facilitate multinational investigator driven clinical trials European Commission Workshop Brussels, 10 November 2009 Burkhardt D. Swik General Manager German Probanden-Cover

2 Introduction: A failed clinical trial This is a drug they have never tested on humans before so they don t know what they are dealing with (press citation) 2

3 Clinical Trials Directive Legal situation in Europe ( Clinical Trials Directive, EU-RL 2001/20/EG) Art. 3 para. 2 f: A clinical trial may be undertaken only if, in particular:...f. provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor. Art. 22 para. 1: They shall apply these provisions at the latest with effect from 1 May Transformation process almost finished. In Germany only minor changes were necessary (2004, 12. AMG-Novelle) 3

4 Clinical Trials Directive 2 - Definition for our topic to be discussed (para. 2 Definitions b:) "multi-centre clinical trial : a clinical trial conducted according to a single protocol but at more than one site, and therefore by more than one investigator, in which the trial sites may be located in a single Member State, in a number of Member States and/or in Member States and third countries. 4

5 Relevant insurance policies i.r.o clinical trials - Other existing relevant insurance protection of the parties acting in clinical trial investigator (professional liability) sponsor (general or professional liability) hospital, CRO (premises operations and professional liability) - Other relevant insurance protection of other parties involved pharmaceutical manufacturer (products liability) ethics committee, authorities (professional liability) 5

6 Clinical trials insurance in selected countries - overview - Compulsory insurance (examples): Germany (accident type), Czech Republic (liability type), France (liability), Netherlands (accident), Japan (liability), New Zealand (liability), Austria (accident), Greece (liability), Portugal (liability), Spain (liability), Poland (liability) sum of insurance often not fixed by the law - Non compulsory insurance (examples, changes possible): Great Britain (liability, special regulation), USA (liability), India (liability), Luxembourg (liability), Mexico (liability) compulsory insurance often to be found if not compulsory, coverage is given in existing normal liability policy frequently 6

7 Compulsory insurance, liability - Spain - Compulsory insurance to cover the legal liability of a sponsor, of the investigator and of the hospital carrier (Art Royal Decree 561/1993). - Strict liability, Art LMed (Ley del Medicamento) - Sums insured = ~ 180,000 per person; average ~ 3 m per clinical trial, resp. ~ 5 m p.a. - Numerous exclusions: by law (Art RD 561/1993) e.g. for characteristic side-effects of the tested drug) or standard by insurance wording (more than 20 exclusions, e.g. genetic damages, non compliance with ethic rules...) - No strict liability / coverage for all third party damages 7

8 Compulsory insurance, accident - NL - Obligation of sponsor to buy accident policy in favour of the subjects in clinical trial (comparable to Germany), 3 Art. 7 Satz 1 Tijdelijk besluit verpflichte verzekering bij medischwetenschapelijk onderzoek met mensen - Decree of 5 July 1999) - Legal liability (negligence) exists, insofar as there is no coverage by the accident policy for the subjects - Exclusions exist e.g. for damages to be expected with certainty or damages resulting from own or contributory negligence - Sums insured (determined by law as minimum; in practice = maximum amounts): ~ 450,000 per subject and ~ 6.8 m per clinical trial and ~ 9 m p.a. in case of annual policies - Loss occurrence: at latest 5 years after clinical trial leaving date of subject 8

9 Non compulsory insurance, liability - UK - No compulsory insurance by law (contested whether requirements of clinical trials directive are met in UK) - MHRA (Medicines and Healthcare products Regulatory Agency) and ethics committees examine, whether sponsor is able to meet compensation claims or provides for a compensation system. Factual need to buy clinical trials coverage - Basis for compensation: ABPI-Guidelines for Medical Experiments in Non- Patient Human Volunteers, 1994 (alternative: Common Law, guiltiness) - Pure causality system (no negligence necessary; Promptly compensation ) - Exclusions e.g. for temporarily pain only, health damages (partially) caused by the subject himself - Sums insured: average between 1 m and 5 m per trial 9

10 Proposed model insurance: accident type Subject in clinical trial compensation direct- claim Clinical trial insurance policy Sponsor / investigator Clinical trial insurer 10

11 Non compulsory insurance, liability - UK para 9.15 of the Governance Arrangements for NHS Research Ethic Committees 2001 Ethics Committees have to consider whether there is provision in proportion to the risk for compensation / treatment in the case of injury / disability / death of a research participant attributable to participation in the research... 11

12 Non compulsory insurance, liability - UK para 11.7 of the ABPI-Guidelines the volunteer should be given a clear commitment that in the event of bodily injury he will receive appropriate compensation without having to prove either that such injury arose through negligence or that the product was defective in the sense that it did not fulfil a reasonable expectation of safety. para 11.8 of the ABPI-Guidelines 1994 A volunteer can reasonably expect that compensation will be paid quickly and that any dispute regarding who will finally bear the cost of the compensation paid to him will be resolved separately by other parties to the research. 12

13 2009 Münchener Rückversicherungs-Gesellschaft 2009 Munich Reinsurance Company THANK YOU FOR YOUR ATTENTION! Burkhardt D. Swik Attorney at Law General Manager German Probanden-Cover Königinstrasse München phone: