CLINICAL TRIAL LIABILITY POLICY

Transcription

1 ACE European Group Ltd. ACE Building 100 Leadenhall Street, London, EC3A 3BP tel fax ACE European Group Limited is authorised and regulated by the Financial Services Authority CLINICAL TRIAL LIABILITY POLICY In consideration of the Insured paying the Premium to ACE EUROPEAN GROUP LIMITED (hereinafter called "the Company") and having made a Proposal which shall be the basis of this contract and is deemed to be incorporated herein The Company will indemnify the Insured subject to the Limit of Liability against all sums which the Insured shall become legally liable to pay as damages or as Compensation (in accordance with the Conditions of Compensation) for any claim made by a Research Subject in respect of Bodily Injury caused by an occurrence which happens within the Territorial Limits after the Inception Date and sustained as a result of participation in the Clinical Trial described in the Schedule Provided that such claim is first made in writing against the Insured during the Period of Insurance and is notified to the Company during or within 30 days after the expiry of the same Period of Insurance. If during the Period of Insurance the Insured becomes aware of an occurrence which may subsequently result in a claim under this Policy and during such period the Insured notifies the Company thereof, any claim later made against the Insured arising out of such occurrence shall be treated as having been made during such period. The Company will also pay Costs and Expenses in respect of any occurrence to which this Policy applies. SIGNED for and on behalf of the Company Andrew Kendrick Chairman and Chief Executive Officer This Policy shall constitute the entire contract between the parties, and should be examined and if incorrect returned immediately for alteration

2 Definitions 1. Bodily Injury means bodily injury sustained by any Research Subject and includes death illness and disease. 2. Clinical Trial means the clinical trial stated in the Schedule being an investigation or series of investigations conducted by or on behalf of the Insured on any person for a medical purpose. 3. Compensation means the amount payable under the Conditions of Compensation. 4. Costs and Expenses means 4.1 costs and expenses recoverable by any claimant from the Insured 4.2 costs and expenses incurred with the written consent of the Company 4.3 the solicitor s fees for representation at any coroner s inquest or fatal accident inquiry or in any court of summary jurisdiction. 5. Employee means any person under a contract of service or apprenticeship with the Insured. Employee also includes the following while working for the Insured, in which case they will be considered to be employed by the Insured 5.1 any person under a contract of service or apprenticeship with another employer and who is hired to or borrowed by the Insured 5.2 any labour master and any person supplied by him 5.3 any person engaged as a labour-only sub-contractor and any person supplied by him 5.4 any self-employed person performing work of a kind ordinarily performed under a contract of service or apprenticeship with the Insured 5.5 any person supplied to the Insured under a contract or agreement the terms of which deem such person to be in the employment of the Insured for the duration of such contract or agreement 5.6 any work experience student or trainee. 6. Inception Date means the date shown as such in the Schedule. 7. Independent Lawyer means a judge retired judge barrister or solicitor. 8. Insured means the party or parties described as such in the Schedule. 9. Limit of Liability means the maximum amount as stated in the Schedule which the Company shall be liable to pay as damages Compensation and Costs and Expenses in respect of all claims made during any one Period of Insurance. 10. Period of Insurance means the period stated in the Schedule or any subsequent period for which the Insured shall have paid and the Company shall have accepted a renewal premium. 11. Research Subject means any person who has volunteered to participate as a subject in the Clinical Trial. 12. Territorial Limits means anywhere within Great Britain Northern Ireland the Isle of Man or the Channel Islands. 13. Proposal means any signed proposal form and declaration and any information in connection with this insurance supplied by or on behalf of the Insured in addition thereto or in substitution therefor whether at the time of acceptance or prior or subsequent thereto.

3 Conditions of Compensation If in the opinion of the Company on the balance of probabilities the Bodily Injury which is the subject of a claim under this Policy was sustained as a result of participation by the Research Subject in the Clinical Trial the Research Subject shall be entitled to Compensation in accordance with the following Conditions 1. (a) Prior to the determination of the Research Subject s claim or the decision of an Independent Lawyer the Insured by way of agreement or court ruling must offer the Research Subject the option of having Compensation in respect of the Research Subject s claim determined in accordance with these Conditions of Compensation and (b) if accepted the Insured shall make an offer of Compensation (subject to the prior agreement of the Company) under these Conditions and the Research Subject must agree or reject the offer within three months following the date of such offer. 2. In the event of Condition 1 occurring but no agreement being reached between the Insured and the Research Subject after three months the amount of Compensation payable under these Conditions shall be determined by an Independent Lawyer experienced in medical litigation and acting as an arbitrator. The choice of the Independent Lawyer shall be made with the agreement of the Company and the Research Subject and in the absence of such agreement the appointment shall be made by the President for the time being of the Law Society of England and Wales or the equivalent body of the country in which the claim is made. 3. In the event of the appointment of an Independent Lawyer such person shall (a) allow the parties a reasonable opportunity to present their cases with both oral and written evidence (b) be entitled to obtain independent expert advice (c) exercise any power conferred upon an arbitrator by any arbitration statute or other law applying in the country in which the claim is made (d) otherwise determine the procedure in order to arrive at a just settlement. 4. In the event that the Insured and the Research Subject agree to be bound by the decision of the Independent Lawyer and the Research Subject accepts the amount of Compensation (if any) in full and final settlement of all causes of action against the Insured or any other person in connection with the Clinical Trial the Company will pay the costs and expenses of the Research Subject which are reasonably incurred in such decision being reached. 5. If the Research Subject (a) (b) rejects the option of Compensation under these Conditions or does not accept the decision and award of the Independent Lawyer within three months the Research Subject shall have no further entitlement pursuant to these Conditions but shall be able to pursue such rights as the Research Subject may otherwise have. 6. If the Research Subject accepts Compensation either by agreement with the Insured or by an award (if any) of an Independent Lawyer then the Research Subject is bound by the following: (a) the Research Subject waives all rights of action against the Insured other than under these Conditions of Compensation and (b) in the event of any payment the Insured (and thus the Company) shall be subrogated to all the rights of recovery thereof which the Research Subject may have against any third party and shall receive all the help and assistance as the Insured (or the Company) may reasonably require from the Research Subject in exercising and enforcing such rights provided that any recovery over and above any Compensation paid or payable to the Research Subject (after deduction of all costs incurred in effecting such recovery) shall accrue to the Research Subject and (c) the Research Subject shall sign an appropriate release or other documents as the Insured may reasonably require to give effect to (a) and (b) of this Condition. 7. Subject to Condition 10 below, Compensation will not be refused solely on the basis that the Bodily Injury arose from a foreseeable adverse reaction or that the Research Subject was warned of the risk but still signed a consent form agreeing to participate in the Clinical Trial.

4 8. Compensation will not be paid for the failure of a product or treatment given in a Clinical Trial to perform its intended purpose. 9. Compensation will not be unreasonably withheld from a Research Subject receiving treatment under the Clinical Trial if the normal treatment which would be applied to relieve an existing medical condition of the Research Subject was withheld or replaced by the administration of a placebo. 10. The amount of Compensation payable shall be made with reference to the amount of damages awarded in similar cases by the courts of the country where the Clinical Trial took place and shall be commensurate with the nature and severity and persistence of the Bodily Injury. The amount of Compensation may be reduced denied or otherwise affected by the following circumstances: (a) negligence of the Research Subject or the Research Subject s parent or legal guardian (b) (c) (d) the seriousness of the injury or illness treated in the Clinical Trial and the degree of probability that adverse reactions would occur and any warning the Research Subject received the comparison of risk between established treatments and those that are used or researched in the Clinical Trial the availability and efficacy of alternative treatments which would have been available to a Research Subject had that person not agreed to participate in the Clinical Trial. 11. The Compensation shall be paid as a single amount of money. 12. The Insured and the Research Subject agree that any action taken under these Conditions of Compensation shall be without prejudice to the position of the Insured and of the Research Subject and shall not be admissible in any legal proceedings.

5 Extensions Indemnity to Others 1. The Company will also indemnify in the terms of this Policy 1.1 any principal with whom the Insured has entered into an agreement to the extent required by such agreement but only in respect of liability for which the Insured would have been entitled to indemnity under this Policy if the claim had been made against the Insured and at the request of the Insured 1.2 any director partner employee or past employee of the Insured in respect of liability for which the Insured would have been entitled to indemnity under this Policy if the claim had been made against the Insured 1.3 any subcontractor doctor consultant physician hospital or contract research organisation or nurse who performs work for the Insured in respect of the Clinical Trial 1.4 any Ethics Committee or its members which has approved the Clinical Trial Provided that a) such person(s) shall not be entitled to indemnity under any other policy b) such party/person(s) shall as though he/they were the Insured be subject to the terms of this Policy in so far as they can apply c) the Limit of Liability shall not be increased hereby. Cross Liabilities 2. Where more than one party comprises the Insured any claim by one Insured against any other Insured shall be treated as though the party so claiming is not an insured party provided that the Limit of Liability shall not be deemed to be increased hereby. Extended Reporting Period If this Policy is not renewed or is cancelled it will nevertheless at the request of the Insured apply to claims first made against the Insured and notified to the Company during the 12 consecutive calendar months (the Extended Reporting Period) immediately following the date of such non-renewal or cancellation Provided that (a) the Limit of Liability is not increased hereby (b) such request by the Insured is made within 10 days of the date of non-renewal or cancellation (c) (d) (e) the Extended Reporting Period will not apply to liability arising from occurrences happening after the date of non-renewal or cancellation the Extended Reporting Period will not apply to liability for which an indemnity is available from any other source the Insured agrees to pay the additional premium required by the Company for the Extended Reporting Period.

6 This Policy does not apply to liability Radioactive Contamination Exclusions 1. of whatsoever nature directly or indirectly caused by contributed to by or arising from 1.1 ionising radiations or contamination by radioactivity from any nuclear fuel or from any nuclear waste from the combustion of nuclear fuel 1.2 the radioactive toxic explosive or other hazardous properties of any explosive nuclear assembly or nuclear component thereof Employees 2. in respect of Bodily Injury sustained by any Employee Fines/ Penalties 3. for fines or under any penalty clause Asbestos 4. for any loss demand claim or suit arising out of or related in any way to asbestos or asbestos-containing materials and the Company shall have no duty of any kind with respect to any such loss demand claim or suit AIDS 5. arising from Hepatitis or any condition directly or indirectly caused by or associated with Human T-Cell Lymphotropic Virus Type iii (HTLV iii) or Lymphadenopathy Associated Virus (LAV) or the mutant derivatives or variations thereof or in any way related to Acquired Immunity Deficiency Syndrome (AIDS) or any syndrome or condition of a similar kind howsoever it may be named Punitive Damages 6. for punitive or exemplary damages Excluded Injury 7. in respect of Bodily Injury sustained by 7.1 any Research Subject who is pregnant at the time of the Clinical Trial 7.2 any Research Subject who is under the age of 5 years at the time of the Clinical Trial Conception/Contraception 8. arising from any Clinical Trial the purpose of which is to 8.1 assist with or alter in any way the process of conception or 8.2 investigate or participate in methods of contraception Genetic Engineering 9. arising from any Clinical Trial involving genetic engineering other than a Clinical Trial in which the purpose is the treating preventing or diagnosing of disease War 10. directly or indirectly occasioned by happening through or in consequence of war invasion act of foreign enemy hostilities (whether war be declared or not) civil war rebellion revolution insurrection or military or usurped power Foreseeability 11. in respect of Bodily Injury reasonably foreseeable by the Insured or by any other party entitled to indemnity under this Policy Known Circumstances 12. arising from any circumstance known to the Insured at the Inception Date Medical Malpractice 13. arising out of or in connection with 13.1 treatment or nursing or the failure to render treatment or nursing of or to any Research Subject 13.2 the exercise of professional skill or any fault error omission in the exercise of professional skill by the Insured or any director or partner or Employee or any independent consultant doctor or nurse 13.3 the use of medical apparatus or equipment.

7 Special Condition The Insured shall ensure that the Clinical Trial complies with the requirements and/or guidelines and/or regulations, whether statutory or otherwise, which apply in the country in which the Clinical Trial is conducted. Conditions Interpretation 1. This Policy and the Schedule shall be read together as one document and any word or expression to which a specific meaning has been attached in any part of this Policy or of the Schedule shall bear such specific meaning wherever it may appear. Choice of Law 2. This Policy of insurance shall be governed by and construed in accordance with the laws of England and Wales, and the Commercial Court, Queen s Bench Division of the High Court of Justice, Royal Courts of Justice, The Strand, London WC2A 2LL shall have exclusive jurisdiction in respect of any dispute arising under this Policy, including any dispute as to the formation or validity of the Policy. Alteration 3. The Insured shall give notice to the Company of any material alteration or change in circumstances affecting the risk covered and until the Company shall have agreed in writing to accept liability for such altered risk the Company shall not provide an indemnity in respect of liability arising from such altered circumstances. Precautions 4. It is a condition precedent to any liability of the Company under this Policy that the Insured at their own expense take all reasonable precautions to prevent occurrences which may give rise to a claim under this Policy. Claims Procedure 5. It is a condition precedent to any liability of the Company under this Policy that in the event of any occurrence giving rise to or which may give rise to a claim under this Policy 5.1 the Insured shall a) give written notice thereof (and full particulars of the occurrence) to the Company as soon as possible b) notify the Company in writing immediately he/they shall have knowledge of any impending prosecution inquest or fatal accident inquiry in connection with any occurrence for which there may be liability under this Policy c) forward to the Company immediately on receipt every claim notice letter verbal notice of claim or other originating process or any other document served on the Insured d) give all such information and assistance as the Company may require 5.2 the Insured or any other party who may be entitled to indemnity under this Policy shall NOT negotiate admit liability or make any promise payment or settlement without the Company s written consent

8 5.3 the Company shall be entitled a) if and so long as it desires, to take over and to have the sole conduct and control of any claim and legal proceedings or alternative disputes resolution relating thereto in the name of the Insured and shall have full discretion in the settlement of any claim b) to prosecute in the name of the Insured but for the Company s benefit any claim for compensation or indemnity. Discharge of Liability 6. The Company may at its sole discretion in respect of any occurrence or occurrences covered by this Policy pay to the Insured the Limit of Liability applicable to such occurrence or occurrences (but deducting therefrom any sum or sums already paid), or any lesser sum for which the claim or claims arising from such occurrence or occurrences can be settled and the Company shall thereafter be under no further liability in respect of such occurrence or occurrences except for the payment of Costs and Expenses incurred prior to the date of such payment and for which the Company may be responsible hereunder (unless the Limit of Liability is stated to be inclusive of Costs and Expenses). Non-Contribution 7. If at the time of the happening of any occurrence covered by this Policy there is any other existing insurance whether effected by the Insured or not covering the same liability the Company shall not be liable to indemnify the Insured in respect of such liability except so far as concerns any excess beyond the amount which would have been payable under such other insurance had this Policy not been effected. Cancellation 8. The Company may cancel this Policy by sending not less than 30 days notice thereof by recorded delivery letter to the Insured at the Insured s last known address. In such event the Company shall make a return of the proportionate part of the premium in respect of the unexpired Period of Insurance from the effective date of cancellation. Contracts (Rights of Third Parties) Act 9. A person or company who is not a party to this Policy has no rights under the Contracts (Rights of Third Parties) Act 1999 in respect of this Policy. This Condition does not affect any right or remedy which exists or is available notwithstanding such Act. Sanction Limitation 10. This insurance does not apply to the extent that trade or economic sanctions or other laws or regulations prohibit the Company from providing insurance, including but not limited to the payment of claims. All other terms Exclusions and Conditions of this Policy remain unchanged.

9 Data Protection ACE European Group Limited and its group companies ( ACE ) will use the information supplied during the formation and performance of this Policy for policy administration, customer services, the payment of claims and the production of management information for business analysis. We will keep this information for a reasonable period. Where sensitive personal data has been disclosed, including any medical or criminal record information, ACE will also use this information for these purposes. ACE are entitled to ask about criminal convictions in relation to insurance risks. There is no obligation to provide ACE with details of any convictions which are spent under the terms of the Rehabilitation of Offenders Act ACE may also transfer certain information to countries that do not provide the same level of data protection as the UK for the above purposes. A contract will be in place to ensure the information transferred is protected. ACE may record telephone calls for quality control, fraud prevention and staff training purposes When personal or sensitive data is supplied to ACE about third parties other than the Insured, both during the formation and performance of this policy, ACE assumes that those third parties consent to the supply of this information to ACE, to ACE processing this data, including sensitive personal data, and to the transfer of their information abroad. ACE will also assume that the supplier of the information is authorised to receive, on their behalf, any data protection notices. ACE may share personal and sensitive personal information with the following organisations for the purposes described above: our connected companies, service providers, agents and subcontractors including loss adjusters and claims investigators; our reinsurers who use this information to assess the terms of specific policies and to administer our insurance polices generally; other insurance companies about other insurance policies you may have; the police, other insurance companies, fraud reference agencies and other representative bodies in relation to the prevention and detection of fraudulent claims or as part of our money laundering checks. We work with the police, other insurance companies, fraud reference and detection agencies and other representative bodies to prevent and detect fraudulent or exaggerated claims. As part of this we will share information about your claims with providers of software designed to assist in the detection of fraudulent claims. We may also use commercially available databases to prevent money laundering. Other companies may contact these bodies for information to help them make decisions about insurance or similar services they provide to you. Individuals whose information has been supplied to ACE are entitled to a copy of that information on payment of a fee and to have any inaccuracies corrected. Such information is available by contacting the Data Protection Officer at 100, Leadenhall Street, London EC3A 3BP. We do not use personal information for marketing purposes, nor do we share it with any other company for marketing purposes, unless consent to do so has been received in writing from you.

10 Complaints Procedure We are dedicated to providing you with a high quality service, and want to maintain this at all times. If you feel that we have not offered you a first class service or you wish to make an enquiry regarding this insurance, please contact the intermediary who arranged this insurance for you or the manager of the branch of the company which issued your policy. If you are still not satisfied, you may write to our Chief Executive of the company at ACE s head office the address is shown on your policy. ACE European Group Limited is a member of the Financial Ombudsman Service (FOS) and in limited circumstances, you can approach them for assistance if you remain dissatisfied with our response. A leaflet explaining its procedure is available on request. The FOS s contact details are FOS, South Quay, 183 Marsh Wall, London, E14 9SR, Phone: enquiries@financial-ombudsman.org.uk. Financial Services Authority ACE European Group Limited, UK Head Office, 100 Leadenhall Street, London EC3A 3BP, authorised and regulated by the Financial Services Authority, registration number FRN Full details can be found on the FSA s Register by visiting or by contacting the FSA on