New legal requirements for conducting clinical trials in Italy
A decree goes into effect March 14th requiring minimum insurance for any company conducting clinical trials in Italy. The new requirements were established by Italy’s Ministry of Labor, Health and Social Policy to safeguard participants in clinical trials conducted wholly or in part in that country.
The requirements state that the insurance policy must cover any civil liability of the sponsor and investigator without excluding any damage which may have been caused by accident or attributed to negligence. In addition to death and permanent and/or temporary injury, damages include economic loss directly resulting from participation in the clinical trial.
The Sponsor of the clinical trial must submit to the Ethics Committees an insurance certificate, in Italian, which must make explicit reference to the proposed study and provide details regarding insurance coverage as required by this decree.
The decree requires the following minimum limits for reimbursement of damages:
- Not less than Euro 1 million per participant
- Euro 5,000,000 if 0-50 participants
- Euro 7,500,000 if 51-200 participants
- Euro 10,000,000 if greater than 200 participants
- No deductible may apply
Another important note is that patients have up to 24 months for the discovery period and 36 months for the extended reporting period (ERP). A 10-year ERP is required for trials involving children, gene therapy, cellular therapy, and radio-pharmaceutical.
For more information on foreign clinical trial requirements, please contact WGA’s Life Sciences Practice.
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.