Chemicals and Life Sciences Industry Practice. Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom

Transcription

1 Chemicals and Life Sciences Industry Practice Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom

2 i Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom

3 introduction Around 940 clinical trials occured in the UK in These trials by their very nature give rise to a range of legal, insurance and risk management issues. This document comments upon the guidance developed by the Association for the British Pharmaceutical Industry (ABPI), the BioIndustry Association and the Clinical Contract Research Association in consultation with the Department of Health and the National Research Ethics Service, for Phase I studies being first into man. The guidance applies to Phase I studies involving both healthy volunteers and subjects who are patient volunteers suffering from a chronic but stable condition, but who do not suffer from the disease that is a target of the research programme. This guidance does not apply where sponsored study is carried out in patients with the disease which the medicine under research is intended to treat. 1 MHRA 2011 Marsh 1

4 The legal position A healthy volunteer who suffers injury as a result of participation in the study of a new medicine will not find it easy to establish an entitlement to compensation. This is because injury can arise in research studies without evidence of fault by either the Sponsor or the Investigator. Similarly, a volunteer will find it difficult to establish strict liability against the producer of the medicine due to (a) the informed consent process and (b) the development risks defence. The above notwithstanding, UK industry generally accepts that there is an obligation to compensate a volunteer even where legal liability under general law could not be established. The insurance position Medicines for Human Use (Clinical Trials) Regulations 2004 applicable to the UK state that a clinical trial may be undertaken only if provision has been made for insurance or indemnity to cover the liability of the Investigator and Sponsor in relation to the trial. The UK Department of Health advises that this requirement is not met by the Sponsor providing evidence of his financial ability to meet a claim made in response to the contractual undertaking given under the ABPI compensation guidelines. Insurance or an indemnity by a third party is required and self-insurance is insufficient. Sponsors in practice choose to take out specific clinical trial insurance that will indemnify the Sponsor in respect of claims made by volunteers, in accordance with the ABPI compensation guidelines. The compensation that the volunteer receives should extend to where the volunteer is injured through negligence of the Investigator. In this situation, the Sponsor (and by subrogation to the Sponsor s rights, the insurer) can separately seek contribution or full indemnity from the Investigator for any payments made in respect of claims attributable to the investigator s negligence. Changes to compensation guidelines A distinction now exists between (a) first into man studies and (b) those studies where experience has been obtained of studies involving comparable doses. A first into man study is defined as the administration of a new molecule to man (healthy subjects and or patients) for the first time by dose (single and repeated), and a new molecule is a unique molecular structure irrespective of whether the molecular class or the therapeutic target is known. A study of a new fixed combination of known active substances, used already in an authorised medicinal product, but not previously used in a fixed combination, is not considered to be a first into man study. The guidance requires a minimum level of cover of 5 million in aggregate per protocol for first into man studies, with such cover reduced to a minimum of 2.5 million in aggregate per protocol in respect of other studies. This is subject to the Sponsor being able to confirm, before the commencement of each study to which this guideline applies, that the required level of aggregate cover is still available in respect of the protocol in question. This is applicable where the Sponsor arranges insurance that applies to more than one study i.e., an annual policy. In each case the aggregate level of indemnity should be exclusive of reasonable legal costs and expenses incurred by the insured i.e., legal costs and expenses to be in addition to the limit of indemnity. The basis of the insurance policy is no-fault liability. This enables the volunteer to obtain compensation without needing to prove either negligence or strict liability, merely that the injury arose through participation in the study. To allow for the possibility that a volunteer s injury will only manifest after the study has ended, the insurance should continue to apply to any claim made within a reasonable period after the completion of the study (final dose) which is determined to be not less than three years. To achieve consistency of approach it is recommended that Ethics Committees, who approve studies, request that the Sponsor provide a declaration of insurance. An example is set out in Appendix 1. 2 Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom

5 Insurance or indemnity of the investigator Before commencing a Phase I study, the Sponsor must indemnify the Investigator (and any Contract Research Organisation (CRO) providing the Investigator) against any loss incurred by the Investigator as a result of claims arising from the study, except to the extent that such claims arise from the negligence of the Investigator. Where the Investigator is negligent, the Investigator remains responsible. The Investigator is understood to be the person responsible for the conduct of a study at a trial site and, where the study is conducted by a team of individuals, is the Principal Investigator. Should the Sponsor pay compensation in circumstances where the investigator is negligent, the Sponsor can seek recovery from any person whose negligence caused the injury. The Investigator(s) must therefore have insurance to cover claims for negligence in respect of its employees or sub-contractors, or must provide evidence of financial resources to meet any such claim. The aggregate level of protection for each study in respect of negligence should generally be equivalent to that recommended in respect of a Sponsor purchasing insurance cover. The Investigator and other physicians involved in Phase I studies must have insurance or indemnity against claims based upon negligence. This could be provided under the insurance of the Sponsor or of the CRO or through personal membership of a medical defence organisation or a policy of insurance purchased personally by the Investigator and other relevant physicians. The aggregate level of protection against negligence should be equivalent to that recommended in respect of a Sponsor purchasing insurance cover. Where the insurance is provided via medical defence organizations it should be confirmed that the insurance extends to cover claims arising from commercially sponsored studies. Nurses and other qualified persons involved in Phase I studies must hold medical professional liability insurance, such as that provided by membership of the Royal College of Nursing. Marsh solution As a leading insurance broker serving the life sciences industry, Marsh is able to offer three products that respond to the new UK Phase I guidelines: Phase I trials insurance available to provide indemnity per protocol Three-year extended reporting period Medical malpractice for investigators is not excluded Legal costs and expenses in addition All other trials 12-month extended reporting period Medical malpractice for investigators is not excluded Legal costs and expenses in addition Annual trials attaching policies Coverage as per either Phase I or All other trials Policy limit available that displays annual aggregate Each time a trial attaches to the policy a new limit will be allowed for that trial Insurance available for Phase I protocol (Up to 15 trials can attach to the policy) Insurance available for all other protocols (Up to 30 trials can attach to the policy) Three-year extended reporting period for Phase I trials 12-month extended reporting period for all other trials Medical malpractice for investigators is not excluded Legal costs and expenses in addition A separate declaration page will be issued demonstrating how the limits accumulate per trial and this can be used to evidence to the Ethics Committee that a sufficient aggregate is available per the new guidelines. Applicable to all policies In order to comply with the ABPI s concerns regarding exclusions there is a separate exclusions page, which will act as a useful and quick point of reference for submissions to Ethics Committees. Marsh 3

6 Appendix 1 MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 PHASE I TRIAL IN HEALTHY VOLUNTEERS APPLICATION FOR ETHICAL REVIEW STATEMENT OF INSURANCE COVER Under Schedule 3 to the Regulations, applications for ethical review of clinical trials should include evidence of any insurance to cover the liability of the sponsor and investigator. Details of insurance for each Phase I trial in healthy volunteers should be provided to the main ethics committee for the trial using this form. It is not necessary to submit the form to committees undertaking site-specific assessment. The form has been designed to be compatible with the guidelines on Phase I trials insurance developed by ABPI, BIA and CCRA in consultation with the Department of Health and the National research Ethics Service. Details of the trial Full title of trial: EudraCT number: Details of the Sponsor s cover Name of sponsor: Please state the aggregate limit of the sponsor s indemnity for this trial: If the cover is arranged in a foreign currency also state the equivalent in GBP: Is there any limit to the indemnity available for an individual participant within the aggregate sum? Yes / No* If Yes, please give details and justify: Is the cover arranged under a trial-specific policy or as part of a block policy for more than one trial? Trial-specific policy / Block Policy* Period of discovery Three years following the end of the trial / Other* If Other, please give details and justify if less than three years: 4 Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom

7 Are there any conditions or exclusions in the policy that would not normally be included in insurance of this type? Yes / No* If Yes, please give details and justify: Details of the insurer Name of insurer: Address: The above named insurer is in receipt of all appropriate authorisations and registrations governing the conduct of its business. Other information Please use this box for any other information you wish to provide the ethics committee about the insurance arrangements for this trial. Insurance certificate A copy of the insurance certificate should be provided to the relevant ethics committee prior to the start of the trial. Enclosed with this form / To follow* Declaration The declaration should be signed by an authorised representative of the sponsor. I declare that the information in this form is accurate to the best of my knowledge and belief and I take full responsibility for it. Signed: Date: Name: Post: Organisation: *Please delete as appropriate Marsh 5

8 Contact Christopher Bryce Industry Practice Leader EMEA Chemicals and Life Sciences Practice Marsh Ltd Tower Place London EC3R 5BU United Kingdom The information contained herein is based on sources we believe reliable and should be understood to be general risk management and insurance information only. The information is not intended to be taken as advice with respect to any individual situation and cannot be relied upon as such. Statements concerning legal, tax or accounting matters should be understood to be general observations based solely on our experience as insurance brokers and risk consultants and should not be relied upon as legal, tax or accounting advice, which we are not authorised to provide. In the United Kingdom, Marsh Ltd. is authorised and regulated by the Financial Services Authority for insurance mediation activities only. Copyright 2012 Marsh Ltd All rights reserved GRAPHICS NO