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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 18, 2017 No. 1115

About approval of Standard rules of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product

According to article 17 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:

Approve the enclosed Standard rules of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of September 18, 2017 No. 1115

Standard rules of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product

1. These Standard rules establish conditions and procedure for the conclusion of the agreement of compulsory insurance of life and health of the patient participating in clinical trial of biomedical cellular product (further - clinical trial), determine including procedure for establishment of the size of insurance rates by compulsory insurance of life and health of the patient, procedure for establishment by the insurer of individual identification code of the patient, procedure for informing the insurer by the insurer on the patients involved in clinical trial, payment procedure of insurance premium, the list of necessary documents for implementation of insurance payment, procedure for realization of the rights and obligations of the Parties under the agreement of compulsory insurance of life and health of the patient in case of damnification of his life or to health as a result of performing clinical trials, the standard rates reflecting nature and extent of damnification to health and extend to the relations, arising from the specified agreement.

2. In these Standard rules the following basic concepts are used:

"patient" - the physical person which was this the voluntary informed consent on the participation in the clinical trials conducted by the medical organization confirmed with its signature or the signature of his legal representative on the information leaflet of the patient;

"insurer" - the organization performing the organization of performing clinical trial to which the obligation on life insurance and health of the patient is in accordance with the legislation of the Russian Federation assigned and which signed the agreement of compulsory insurance of life and health of the patient with the insurer;

"insurer" - the insurance company which is performing insurance activity in accordance with the legislation of the Russian Federation and signed the agreement of compulsory insurance of life and health of the patient with the insurer;

"agreement" - the agreement of compulsory insurance of life and health of the patient under which the insurer shall for the payment (insurance premium) caused by the agreement in case of approach of the event (insured event) provided in the agreement to perform to insured person (beneficiary) in case of damnification of life or to health of insured person the insurance payment provided by the agreement;

"insured person" - the patient whose valuable interest connected with damnification of his life or to health as a result of performing clinical trial is insured under the agreement;

"the insurance act" - the document constituted by the insurer and containing data on consideration by it of the requirement about implementation of insurance payment, including about availability or about lack of insured event, about insured person (beneficiary) and about the amount of the insurance payment which is due to it or about the refusal bases in its implementation;

"individual identification code of the patient" - set of the signs identifying the specific patient.

3. The agreement is signed between the insurer and the insurer for the benefit of the patient in accordance with the legislation of the Russian Federation and these Standard rules.

4. In case of damnification of life of insured person by beneficiaries under the agreement are:

a) the citizens having the right to indemnification in case of the death of the supporter according to Item 1 of Article 1088 of the Civil code of the Russian Federation;

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