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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 13, 2010 No. 714

About approval of Standard rules of compulsory insurance of life and health of the patient participating in clinical trials of medicine

(as amended on 15-10-2014)

According to article 44 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

Approve the enclosed Standard rules of compulsory insurance of life and health of the patient participating in clinical trials of medicine.

Russian Prime Minister

V. Putin

Approved by the Order of the Government of the Russian Federation of September 13, 2010 No. 714

Standard rules of compulsory insurance of life and health of the patient participating in clinical trials of medicine

I. General provisions

1. These Standard rules establish insurance rates on compulsory insurance of life and health of the patient participating in clinical trials of medicine for medical application (further - clinical trials), 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 participating in clinical trials in case of damnification of his life or to health as a result of performing clinical trials 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 which is performing the organization of performing clinical trial to which the obligation on life insurance and health of the patient participating in clinical trials is in accordance with the legislation of the Russian Federation assigned, and signed the contract with the insurer;

"insurer" - the insurance company which is performing insurance activity of certain type in accordance with the legislation of the Russian Federation and signed the contract with the insurer;

"agreement" - the agreement of compulsory insurance of life and health of the patient participating in clinical trials 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 trials 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 by insurance company for benefit of the patient participating in clinical trial, in accordance with the legislation of the Russian Federation and based on these Standard rules.

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

a) the following citizens having the right to indemnification in case of the death of the supporter according to the civil legislation:

the disabled persons consisting dependent on the died insured person or his death which had by day the right to content from it;

the child of the died insured person who was born after his death;

one of parents, spouses or the family member irrespective of its working capacity who does not work also is busy with care of his children who were dependent on the died insured person, grandsons, brothers and sisters who did not reach 14 years or though reached the specified age, but according to the conclusion of medical bodies needing for health reasons foreign leaving. One of specified persons who became disabled during leaving implementation keeps the right to indemnification after its termination;

the faces which were consisting dependent on the died insured person and became disabled within 5 years after his death;

b) parents, the spouse, children of the died insured person - in the absence of the citizens specified in the subitem "an" of this Item;

c) citizens dependent on whom there was insured person, - in case of the death of the insured person who did not have the independent income;

d) person who incurred expenses on burial of insured person - concerning compensation of such expenses.

5. The requirement about indemnification caused to life or health of insured person as a result of performing clinical trials are satisfied during the terms of limitation period established by the civil legislation.

II. Object of compulsory insurance, insured event

6. Object of compulsory insurance is the valuable interest of insured person connected with damnification of his life or to health as a result of performing clinical trials.

7. Insured event is the death of insured person or the deterioration in his health including involving disability establishment in the presence of causal investigative communication between approach of this event and participation of the specified person in clinical trial of medicine.

III. Amount of insurance payment

8. The amount of insurance payment for the agreement constitutes:

a) in case of the death of insured person - 2 million rubles. Insurance payment in the specified size is distributed between beneficiaries in proportion to their quantity in equal shares;

b) in case of the deterioration in health of insured person which entailed:

establishment of disability of the I group - 1, 5 million rubles;

establishment of disability of the II group - 1 million rubles;

establishment of disability of III group - 500 thousand rubles;

c) in case of the deterioration in health of insured person which did not entail disability establishment - no more than 300 thousand rubles.

9. The amount of the insurance payments specified in Item 8 of these Standard rules can be increased based on the judgment.

IV. Insurance rates, payment procedure of insurance premium

10. The size of insurance rate is established by multiplication of the rate of insurance rate determined depending on the purposes of performing clinical trial of medicine by the number of patients and on coefficient of insurance rate.

11. The rate of insurance rate concerning 1 patient constitutes:

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