OREANDA-NEWS. June 10, 2011. In St. Petersburg, a conference was held on the topic "Current Issues of Pre-Clinical and Clinical Drug Trials", arranged by the RF Ministry of Health and Social Development in accordance with the plan for practical research events scheduled by the said Ministry for 2011. At the conference, the issues related to clinical trial insurance were covered by Mr. Ivan Lypin, Chief Specialist of the Corporate Sales Department of ROSNO’s North-Western Directorate, reported the press-centre of ROSNO.  

The major purpose of the event was to discuss the opportunities for improvement of the quality of pre-clinical and clinical drug trials, the issues related to accreditation of the institutions conducting clinical trials, ethical aspects of pre-registration trials, etc. The conference was attended by M.R. Sakayev, head of the Department of State Regulation of Drug Circulation of the RF Ministry of Health and Social Development, A.N. Mironov, director of FGBU Scientific Centre for Inspection of Medical Goods, S.M. Yashin, acting Rector of GOU VPO Academic I.V. Pavlov St. Petersburg State Medical University, etc.

ROSNO’s speaker told about the latest changes in the legislation on clinical drug trials. Starting 01 September 2010, due to adoption of the Federal Law "On Drug Circulation" and the RF Government Regulation No. 714 dated 13 September 2010 (as amended on 18 May 2011, No. 393), a new procedure and terms of obligatory insurance coverage of patients participating in clinical trials were enacted: in particular, the standard insurance rules describing the procedure for conclusion of insurance contracts, the procedure for document circulation between the insurant and the insurer, the procedure for assignment of an individual patient identification code, insurance rates, and other nuances.

"This legislative change provides for simpler scheme of document circulation between the insurant and the insurer. Such concepts as „preliminary“ and „basic“ insurance contracts have been gone, and now only one contract — the contract for obligatory insurance coverage of life and health of the patients participating in drug clinical trials — is concluded. Another important aspect is that now the insurance contract becomes effective only upon full payment of insurance premium, provided that there is a permit for performance of the clinical trial, and upon receipt by the insurer of a register of individual patient identification codes", comments Ivan Lypin.

ROSNO presented at the conference its new product related to obligatory insurance coverage of patients participating in drug clinical trials, developed in accordance with the latest legislative changes, and the company’s special offer — voluntary insurance coverage of civil liability of the entities conducting clinical trials (sponsors, medical centres, research entities).