Compulsory third party liability insurance of the sponsor and investigator for damages caused in connection with the clinical trial on a medicinal product and selected other compulsory insurances in medicine Cover Image

Obowiązkowe ubezpieczenie odpowiedzialności cywilnej sponsora i badacza za szkody wyrządzone w związku z przeprowadzeniem badania klinicznego produktu leczniczego a wybrane inne medyczne ubezpieczenia obowiązkowe
Compulsory third party liability insurance of the sponsor and investigator for damages caused in connection with the clinical trial on a medicinal product and selected other compulsory insurances in medicine

Author(s): Damian Kaczan
Subject(s): Civil Law
Published by: Polska Izba Ubezpieczeń
Keywords: clinical trial on a medicinal product; pharmaceutical law; third party liability insurance; medical experiment; healthcare activity

Summary/Abstract: The article is devoted to the third party liability insurance of the sponsor and investigator involved in conducting a clinical trials on a medicinal product. This issue is presented in two chapters on the back- ground of, respectively, third party liability insurance of the entity performing healthcare activity and liability insurance of the entity conducting the medical experiment. The analysis covers both the pro- visions of the relevant acts, which imply the obligation to make contracts of insurance, and the provi- sions of the ordinances defining scope and minimum guarantee amounts of the above-mentioned types of insurance. The study also took into account the order formulated by the EU legislator towards national legislators to create an appropriate system of compensation for harm suffered by subjects in clinical trials on a medicinal product.

  • Issue Year: 2022
  • Issue No: 3
  • Page Range: 61-76
  • Page Count: 16
  • Language: Polish