Home > Property & Casualty > Pending changes to insurance standards for Russian clinical trials

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.

  1. September 1, 2010 at 10:11 am

    The latest news is that there will be a “General Russia Clinical Trial Policy” and the list of the patients participating in the study (http://www.wgains.com/assets/attachments/Articles44Law.pdf). Such list will be an integral part of the General Policy. A separate Policy will be issued (for each Patient) which confirms that there is a General Policy. New test subjects added to the study will be added via Endorsement. We’ll continue to keep you posted as we learn more, in the meantime contact a member of the WGA Life Sciences team with specific questions.

  2. October 22, 2010 at 2:31 pm

    Update – On September 13, 2010, the Russian Government issued Resolution No. 714, “On Approval of the Standard Regulations of Compulsory Life and Health Insurance of Patients Participating in Pharmaceutical Drug Clinical Studies.” Sponsors of clinical trials in Russia must provide a Life and Health Insurance policy for each patient. The benefits and premium rates are pre-set in Resolution No. 714. The Sponsor can arrange a ‘General Policy’ for a particular protocol , but it will be the responsibility of the investigator to provide information to the insurance company to produce the necessary insurance documents for each individual trial participant. Sponsors, CROs, Investigators and Clinical Sites should address this new requirement in their contracts and agreements. This compulsory Life and Health Insurance does not take the place of the locally-placed clinical trial liability insurance policy.

  3. Amy Sinclair
    April 27, 2011 at 8:25 am

    The Law on State Pensions in Russian Federation defines three groups of disability depending on the degree of health damage. Individuals who have completely lost regular work capacity are assigned to Category I if they require permanent care, and to Category II if they the disability is not inherently permanent. Those with only partial disability, whether or not permanent, are assigned to Category III. A special medical commission defines disability status. It is reconsidered every two years for the first group, and annually for the second and third groups, except for those individuals who have reached official retirement age or have incurable diseases.

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