SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Study participants

Responsible for covering insurance

Sponsor

Applicable national legal framework/ Reference

(1)
- Chapter 2, Section 2(4) Regulation 2009 for clinical trials (Insurance for trial subjects agaist any harm that may arise during the trial)
- Chapter 3, Section 3(2) Regulation 2009 for clinical trials (Insurance or compensation to cover the liablility of investigator and sponsor)
(2)
These provisions are based on the regulations set out in The Product Liability Act (en) of 23 December 1988, Chapter 3, concerning liability in the case of injuries caused by drugs.

Additional Information

Pursuant to the national legislation, the manufacturers and importers of drugs and persons conducting clinical trials on drugs are obliged to join the Drug Liability Association/ Legemiddelansvarsforeningen (LAF) and take out a special insurance, the Drug Insurance, which will indemnify any injured persons on a no-fault basis, that is, regardless of culpability. 
Detailed information is provided on the LAF website in section Liability Insurance in connection with Clinical Trials of Drugs.

Insurance may be provided by:
(1) Private Insurance company OR
(2) Norwegian System of Patient Injury Compensation (Norsk Pasientskadeerstatning; NPE)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395