OREANDA-NEWS. November 25, 2010. Due to the enactment of new terms of obligatory insurance coverage of clinical trials (Federal Law "On Drug Circulation" and RF Government Resolution No. 714), IC ROSNO has supplemented its product line with a new program contemplating obligatory insurance of life and health of patients participating in drug clinical trials. ROSNO’s experts held a seminar on this important topic for pharmaceutical companies performing clinical trials and other interested parties. In total, 56 companies attended the seminar, reported the press-centre of ROSNO.

IC ROSNO has been insuring clinical trials for ten years already. During the last three years, the company concluded almost 900 clinical trial risk insurance contracts.

The new terms of obligatory insurance of patients participating in clinical trials do considerably differ from the previous terms of voluntary insurance.

To explain the changes to the participants of the pharmaceutical market, IC ROSNO arranged a seminar. The purpose of this event was to show the opportunities resulting from the successful cooperation between the clinical trial companies and insurers in a new regulatory environment.

The participants were presented the optimal procedure for conclusion and support of the insurance contract taking into account regulatory requirements and interests of clinical trial organizers and patients. A clinical trial permit issuance procedure can be initiated on the basis of the preliminary agreement. Once the obligatory life and health insurance contract is concluded, ROSNO will issue insurance policies to each patient, protecting personal data and confidentiality of the information it has received.

"The protection of property interests of the patients participating in clinical trials, which is guaranteed by the newly enacted law, is, undoubtedly, of great social importance. ROSNO is ready to provide reliable and professional insurance in strict compliance with the law. However, as of now, regulatory provisions related to obligatory insurance coverage of clinical trials contain a number of contradictions hampering the work of both insurants and insurers, notes Ms. Galina Goulyaeva, head of ROSNO’s Liability Insurance Centre. — We hope that the market regulators will soon enact additional regulations eliminating these contradictions. As for now, we have tried to work out an arrangement enabling our insurants to comply with all of the new requirements".