For the purpose of monetary compensation, injuries and adverse effect of clinical drug trials will be classified into four types
The Union Ministry of Health and Family Welfare (MoHFW) has recently published a possible formula to determine the compensation in case of clinical drug trials resulting in serious adverse effects (SAE). According to the draft, for patients whose expected mortality is 90 per cent or more within 30 days, a fixed amount of Rs 2 lakh should be given.
The committee, headed by health secretary R K Jain, has decided to keep the base amount of Rs 8 lakh in case of SAE resulting in death. Victims will be classified into one of the four categories of SAE and will be compensated accordingly. In case of permanent disability, the compensation would be 80 per cent of base amount while a lump sum amount is to be deposited in the bank such that if that amount is kept by way of fixed deposit or alike, it should bring a monthly interest amount which is approximately equivalent to half of minimum wage of an unskilled worker (in Delhi). In such cases the committee suggested that the amount could be around half of the base amount which is Rs 8 lakh.
In the case of chronic life threatening disease, the quantum of compensation is to be linked to the duration (in days) for which the subject remained under life-threatening situation and required medical care, irrespective of number of days of hospitalisation. The committee also considered that compensation per day in such cases should be equal to daily minimum wage of unskilled worker (of Delhi).
In case of clinical trial-related SAE which was reversible and resolved, the quantum of compensation is to be linked to the number of days of hospitalisation of the subject. The compensation, per day of hospitalisation, would be equal to the wage loss. The wage loss per day would be calculated based upon the minimum wage of the unskilled worker (in Delhi).
The financial compensation will be over and above the expenses incurred on the medical management of the trial subject.
The committee report has said that in case of SAE of death, the Drugs Controller of India will determine the cause of death and decide the quantum of compensation after considering the recommendation of independent expert committee constituted for the purpose. One independent committee has chalked out a formula which uses base amount (Rs 8 lakh) factor depending on the age of the subject and risk factor depending on the seriousness and severity of the disease. It is already in use, says the report.
The committee has requested all stakeholders to give comments or suggestions on the above formula within 15 days (by May 16).
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