20 & 21 October 2005 Clinical trials Risk issues within a wider Europe. Adrien Collovray Marsh Life Science Conference 2005 Berlin, Germany

Transcription

1 20 & 21 October 2005 Clinical trials Risk issues within a wider Europe Adrien Collovray Life Science Conference 2005 Berlin, Germany

2 Clinical trials EC Directive on clinical trials Insurance Requirements Patient Information and Consent Forms Delays Ethics Committees present and future 2

3 Clinical trials EC Directive on clinical trials The EU directive on clinical trials (2001/20/EC) refers only to Medicinal products. It defines a Clinical trial as: "Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s) and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State." 3

4 Clinical trials EC Directive on clinical trials An Investigational Medicinal Product is defined as: A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (Formulated or packaged) in a way different from the authorised indication, or when used to gain further information about the authorised form. A sponsor is defined as: An Individual, company or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial. 4

5 Clinical trials EC Directive on clinical trials The CT Directive 2001/20/EC (May 2001) Guideline: EnduraCT (A Database that provides an overview of trials in the EU to the Authorities) Ethics Committees (Responsibilities and Review timelines) CTA and amendments Safety reporting Pharmacovigilance CT Database 5

6 Clinical trials EC Directive on clinical trials The Purpose of which is to: Protect trial subjects Improve quality of clinical research Produce credible data, Introduces Inspection on adherence of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) Reduces duplication of paper work by harmonizing requirements and procedures 6

7 Clinical trials EC Directive on clinical trials What does this mean: There is a greater emphasis on the sponsor to adhere to set procedures, GMP and GCP guidelines backed up by inspections which the Inspectorate needn t provide prior notice of. 7

8 Clinical trials Insurance We need to be aware of three main types of insurance relating to clinical trials insurance: Bodily injury/death coverage to a patient undertaking the trial as describe and defined by the protocol Error and Omissions cover particularly in respect of the production of the protocol and PICF Medical Malpractice coverage for the Investigators and clinical staff undertaking the Trial 8

9 Clinical trials Patient insurance Many countries hastily pushed though legislation to comply with the new directive Italy made local insurance compulsory, but whilst considering coverage requirements is allowing Ethics Committees to dictate limits, tail periods etc Switzerland only accepts Insurance where the named Insured is a Swiss legal entity Belgium requires unlimited strict liability Although the directive only states: A clinical trial may be undertaken only if... (f) provision has been made for insurance or indemnity to cover the liability of the sponsor. 9

10 Clinical trials Patient insurance Clinical Trials Insurance requirements are very varied across Europe. Admitted Vs Non Admitted Fault Vs No fault Limits (aggregate/per patient) Run off coverage EC requests Vs legally required 10

11 Clinical trials Patient insurance Two varied examples Germany: Clinical Trials insurance in Germany Compulsory insurance for any clinical trial study for drugs according to Drug Law (Art. 40 AMG) German insurer licensed for this business, reinsured typically by so-called Probandencover (linked to Pharmapool) Limit: 500k per patient enrolled (each study) Maximum aggregate limit t.b.a. per study: 50m Equivalent Laws for MPG (German legislation) and Radiation. EC Requests, Accident Insurance 11

12 Clinical trials Patient insurance The United Kingdom: No compulsory insurance; however, insurance is always required in practice Local policy is recommended Typical limit: 2m per claim and in the annual aggregate Certificate may be issued from the General Liability policy Specification that insurance covers no-fault liability is recommended (ABPI and ABHI Guideline) 12

13 Clinical trials Patient insurance Insurers Limited Markets USA Data required by Insurers varies dependant upon country. Commonly requested are: Questionnaire, Protocol Patient Information and consent form (In English and Local language) Mid-term changes to these items must be advised to insurers as coverage is not automatic 13

14 Clinical trials Patient information and consent form This Patient Information and Consent Form (PICF) is extremely important in risk management terms. A large proportion of claims will come from a trial participant stating they were not advised of a SUSAR (Suspected Unexpected Serious Adverse Reactions) or procedure. This is particularly the case since the expansion of trials into eastern Europe. The patient population in a number of these countries is relatively naïve about clinical trials, and therefore making the PICF and its clarity of utmost importance. 14

15 Clinical trials Errors and omissions insurance This line of coverage is for the protection of the party who produce the protocol and the Patient information and consent form. This is not required by Ethics Committees and therefore will not cause a delay to the trial however it is equally vital to ensuring the effect risk management of a trial. 15

16 Clinical trials Medical malpractice insurance It is important to ensure Investigators and site staff have Medical Malpractice coverage in Place. This insurance is to ensure coverage for trial participants in the event that the site staff are negligent or have deviated from the protocol (Which is a material fact in a sponsors trials coverage) This should be the responsibility of the Investigator or hospital to provide evidence of this coverage. Evidence of this coverage can be requested by an Ethics Committee and therefore could delay trial start up. 16

17 Clinical trials Delays Delays to a trial can be very expensive. It has been estimated that a delay to a large trial can cost US$1m per day Delays can be caused by a number of factors, a number of which are described in this presentation. 17

18 Clinical trials Ethics committees Following the implementation of the EU Directive on clinical trials, Ethics Committees have greater responsibility and accountability for trials they authorize. The result is that they have been much more stringent with their requirements. We would suggest early contact with the Ethics committees to establish their requirement especially where requirements are not specifically defined by law. 18

19 Clinical trials Were does fit in? established the need for coordinated Clinical trials activities around the world with a view to keeping up to date with regulations and ensuring prompt efficient service to our client in a very diverse rapidly changing section of the insurance market. To tackle this issue we have developed the Clinical Trials Centre of Excellence with local experts around the world working via a coordinated network. This provides us a centralised knowledge and placement centre with in the field expertise. 19

20 Clinical trials The future Streamlining via a centralised insurance database: Direct access to insurance requirements Faster and more efficient coverage requests Client certificate/policy online library Automated certification 20

21 Clinical trials Risk issues within a wider Europe 21

22 The information contained in this presentation provides only a general overview of subjects covered, is not intended to be taken as advice regarding any individual situation and should not be relied upon as such. Insureds should consult their insurance and legal advisors regarding specific coverage issues. This presentation or any portion of the information it contains may not be copied or reproduced in any form without the permission of Ltd, except that clients of Ltd need not obtain such permission when using this report for their internal purposes. Ltd is authorised and regulated by the Financial Services Authority Copyright 2005 Ltd All rights reserved 22