The object insured
Civil liability of the applicant for clinical trials as a result of the harm caused to patients / healthy volunteers who participate in trials.
Damage to life or health of patients / healthy volunteers as a result of clinical trials
- Death as a result of participation in clinical trials of medicines
- Disability / permanent health disorder as a result of participation in clinical trials of medicines
- Temporary incapacity / temporary health disorder as a result of participation in clinical trials of medicines
Who can take advantage of this insurance product
This type of insurance is an obligatory condition for realization of clinical trials of medicines on territory of Ukraine. Thus the declarant of clinical trials (sponsor, contract research organization) in the obligatory order must conclude an insurance agreement of responsibility to patients for the damage to their life and health as a result of clinical trials.
Size of responsibility of insurance company (amount covered)
In common practice insurance companies continue to adhere to recommendations of the Central Commission for Ethics Matters of МОH of Ukraine (the organ that was disembodied by the order of МОH from 11.04.2012 № 255) in relation to establishment of amount covered per one patient not less than USD 10 000. It is important to note that our insurance company can take considerably anymore insurance responsibility for effective protection of interests of trial subjects.
Insurance premium is determined by mutual consent of parties in the insurance agreement after an estimation of all risks by the insurance company on the basis of information about a clinical trial.
Quality of insurance product can be confirmed by the following:
- Our company has realized this insurance product since 2000.
- Our specialists passed a certification under western programs of the strictly specialized professional studies (ICH – GCP) and well-informed as to the stages of developments and features of action of drugs, international principles of realization of clinical trials and protection of trial subjects.
- There is no fluctuation of personnel in our company and as a result we have an experience and complete complex of knowledge and practical skills for organization of successful activity from clinical trials insurance.
Basic Insurance Tariffs
From 0.45% to 1.85% depending on the pharmacological group of drugs and the limit of liability