The new edition of the Law of the Republic of Uzbekistan “On medicines and pharmaceutical activity” entered into force on 5 January of the current year. In accordance with article 10 of this Act “Before starting clinical studies of a drug, a treatment facility conducting the research, or the legal entity, who conducts the research of a pharmacological or medicinal product, is obliged to conclude an insurance contract of civil liability for causing harm to the life or health of the patient”.
In this regard, the National Export Import Insurance Company “Uzbekinvest” has developed a new insurance product, under which the company is willing to provide insurance protection of civil liability for causing harm to the life or health of a patient of treatment-and-prophylactic institutions and other legal entities (insurers), who conducts a research of the pharmacological or medicinal product.
The insurance contract is concluded in favor of the patient, a volunteer, undergoing the test of a new pharmacological drug.
Under this agreement, the liability of the insurer before each patient is insured for personal insurance amount, within which the company is willing to make insurance payment to the patient or his heirs for harming life and/or health of the patient.
Insurance cover also applies to cases of harm to life, health of the patient, which occurred within 1 year after the end of clinical trials conducted in the period of validity of the insurance contract, provided that there is proof of the existence of a causal link between the ongoing clinical research and the fact of infliction of harm to the patient.
The above Law is “permits clinical research of pharmacological drugs without the conclusion of an ethical evaluation about the ethical propriety of their conduct”.
Hereby, the relevant insurance contract of civil liability is considered as one of the required documents when submitting an application to the ethics Committee for passing ethical review.