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Mandatory Life and Health Insurance of Patient Participating in Clinical Trial
What is it for
An organization that has a license to conduct clinical trial of medicinal product for medical use, in accordance with Law No. 61-FZ, is obliged to insure the risk of damage to life and health of the patient as result of conducting the clinical trial of medicinal product for medical use at its own expense by concluding a mandatory insurance contract.
Who can insure
Company that has a license to conduct clinical trial of a medicinal product
What can be insured
Patient’s life or health as result of clinical trial
Patient’s life or health components
- death of patient participating in clinical trial of a drug
- deterioration of patient's health, which led to the establishment of degree of disability
- deterioration of patient's health, not entailing the establishment of disability
Additional information
The term of mandatory insurance contract cannot be less than the term of the clinical trial of medicinal product
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FAQ
What is the amount of insurance payments under life and health contract for a patient participating in clinical trial of medicinal product for medical use?
The amount of insurance payment under the compulsory insurance contract is:
- RUR 2,000,000 in case of death of the patient who participated in clinical trial of medicinal product;
- RUR 1,500,000 in case of deterioration in the patient's health, which entailed the establishment of Degree I Disability;
- RUR 1,000,000 in case of patient's health deterioration, which entailed the establishment of Group II Disability
- RUR 500,000 rubles in case of patient's health deterioration resulting in the establishment of Group III Disability
- Not more than RUR 300,000 in case of patient's health deterioration, which did not entail the establishment of disability
Is it possible to expand coverage for an organization?
You can additionally include liability insurance
How long does it take to issue the insurance contract?
One day
In case of damage to the life of a patient participating in clinical trial of a drug, who is the beneficiary?
The beneficiaries under the mandatory insurance contract are individuals who are entitled to compensation for damage in the event of breadwinner’s death in accordance with the Civil Code: parents, children, spouse, individuals on whom the patient was dependent
How is the insurance payment distributed among the beneficiaries?
The insurance payment for causing damage to the life of patient participating in clinical trial of a drug is distributed in proportion to their shares.
How quickly is the insurance payment made?
The insurance payment is made by the insurer within thirty days from the date of submission of the necessary documents.