It has come to my attention, that a number of NIH-funded Clinical Trials appointing Denmark as a Site, have difficulties understanding the Danish state self-insurance scheme. This is how it works.

Martin Binzer Lind is the author of this minute and any copying shall be subject to his prior approval.

Outline of self-insurance scheme in Denmark

The Danish public bodies are prohibited from taking out insurances, e.g. Ministerial Circular of 9 december 2005, section 1, (1). The Circular states in section 2, (1), (ii), that institutions whose income and expenses are laid down in the Danish Appropriations Act, are obligated by the Order.

The University of Copenhagen is an institution under the Danish Appropriations Act, c.f the Danish Act on Universities, consolidated act no. 261 of 18 March 2015.

Section 11 of the Circular states that the liability to pay damages and the size of a possible compensation are determined in accordance with the general rules of Danish law and the rules set out therein on the Danish state as self-insurer. Further, the Danish General Act on Liability section 20 states, that the public bodies are self-insured.

This XX Project is not defined as a clinical trial and the Danish site is not located at a hospital. The Principal Investigator is not a Health Care Professional. However the Danish Act on the Right to Complain and Receive Compensation within the Health Service (consolidated Act no. 84 of 17 January 2017, as amended), applies in this case due to the acts section 19 (2), and Ministerial Order 1265 of 28 October 2016 section 11.

Outline of the key regulators and their powers.

The Danish Act on the Right to Complain and Receive Compensation within the Health Service (consolidated Act no. 84 of 17 January 2017, as amended) covers injuries occurring in private and public hospitals and those caused by authorised health professionals in private practice.

The Act applies to injuries suffered by study- participants to a clinical trial that is part of a treatment where a hospital, governmentally-funded educational unit or general practitioner is in charge of the trial, cf. section 19 (2) of the Act.

Decisions under the Act are made by the Patient Compensation Association

The Association’s website (http://pebl.dk) includes information in English on the Association’s activities, and translations of the Act and the Act on Liability for Damages (consolidated Act no. 266 of 21 March 2014, as amended). The Act on Liability for Damages governs the methods for evaluating and calculating damages. Please check the FAQ for an explanation of the Danish self-insurance scheme.

Study subjects in this project xx are insured on the same terms as patients.