Pending changes to insurance standards for Russian clinical trials
Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The changes are related to the regulatory approval process being transferred from the Federal Service on Surveillance in Healthcare and Social Development to the Ministry of Health and Social Development. The majority of this criteria is related to investigator sites, mainly to contracts with investigators, investigator experience, patient consents and insurance amounts. Unfortunately, the current version of the law is full of inconsistencies and requires further clarification. Many CROs are still evaluating how these changes will affect studies (specifically on start-up operations) and continue to report any new developments. The relationship between the Insurer, Insured (sponsor) and the Patient (test subject) will be defined in these new proposed regulations which are still pending approval by the Government of the Russian Federation. At this time no such “regulations” have been approved and this continues to be closely monitored.