U.K. issues updated guidelines for Phase 1 clinical trials
Effective immediately, changes have been made to the UK regulations governing insurance solely for Phase 1 clinical trials. The guidelines were developed by the Association for the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA) in consultation with the Department of Health and the National Research Ethics Service to provide insurance coverage recommendations based on industry best practices and claims history. Sponsors can then use the guidelines to prove to Ethics Committees that adequate insurance policies are in place for patient volunteers on a “no-fault” basis.
The guidelines apply to both healthy volunteers as well as patient volunteers suffering from a chronic but stable conditions not related to the target disease, where the administration of medicine is to obtain additional pharmakinetic data about the medicine under research. Trials in which a patient with the target disease is being treated with the medicine being studied are exempt from the updated guidelines.
A summary of these guidelines follow:
- Phase 1 First in Human studies will require £ 5M in the aggregate per protocol. This limit is already required by the NHS hospitals
- For all other phase 1 studies, £ 2.5M in the aggregate per protocol will suffice. Sponsors should consider limits of £ 5M regardless of this requirement
- Policies covering multiple protocols are still acceptable; however Sponsors need to consider purchasing higher limits to ensure an adequate level of cover is maintained
- No patient sublimits are allowed
- Self-insurance is not allowed. Sponsors must purchase commercial insurance to meet their potential liabilities
- A three-year discovery period is required
- Reasonable legal costs and expenses should be in addition to the limit of liability, not included in the limit. The impact for Sponsors insuring Phase I clinical trials in the UK under a global policy issued in the U.S. is undetermined at this time
- The insurance should not exclude injury resulting from negligence of the investigator, but similar to Germany, insurers are allowed to subrogate against the responsible party
- The Investigator has an independent obligation to ensure that they have adequate insurance or indemnity, but for additional premium, a policy may be extended to cover claims made directly against the Investigator which would not ordinarily be covered by the indemnity given to the Investigator by the Sponsor
- It is recommended that Ethics Committees accept the presentation by a Sponsor of a declaration of insurance and a template has been provided
For further information on the updated guidelines click here.
About the Author
Amy Sinclair is a Senior Vice President and co-leader of the Life Sciences Practice in WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.