Provisions setting out the need to conclude contracts for insuranceof the life and health of the patient (volunteer) for possible damage to their life and health as a precondition to conduct a clinical trial were excluded from the Procedure for Conducting Clinical Trials.
Thus, on July 18, 2014 the order of the Ministry of Health of Ukraine d.d. May 06, 2014 # 304 "On Amendments to the Order of the Ministry of Health d.d. September 23, 2009 # 690" (hereinafter - the Order) entered into force.
It should be reminded that the Order was approved pursuant to the decision of the State Service of Ukraine for Regulatory Policy and Entrepreneurship Development d.d. 26 February, 2014 # 23 "On the need to eliminate violations of the principles of state regulatory policy in accordance with the Law of Ukraine "On the Principles of State Regulatory Policy in the Area of Economic Activity" by the Ministry of Health of Ukraine.
At the same time, the Law of Ukraine "On Medicinal Products" obliges the sponsor of the clinical trial to conclude the contracts of insurance of the life and health of the patients (volunteers) prior to its commencement.
It is indicated in the decision that this type of insurance contract is not among the types of compulsory insurance in accordance with the Law of Ukraine "On Insurance", the form of the model contract, which must be approved by the Cabinet of Ministers of Ukraine, is also unavailable. That is, the review of the fact whether the insurance contract is concluded at the start of clinical trials does not correspond to the Law of Ukraine "On Insurance".
The requirements for written and oral information provided to the patient (volunteer) or legal representative/close relative are also changed. In particular, such information will include data on contract for insurance of the life and health of the patient (volunteer) with the name and location of the insurance company, number and date of concluding the contract. These changes are set out in the Addendum # 2 to the Order.
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