The Union health ministry has issued the much-awaited formula to determine the quantum of compensation in the cases of deaths occurring during clinical trials in India. The formula was prepared by an independent expert committee constituted by the Drug Controller General of India (DCGI) in March this year under the chairmanship of Dr A K Agarwal of Maulana Azad Medical College, New Delhi.
After detailed deliberations, the committee came to the conclusion that the age of the subject and the risk factor depending on the seriousness and severity of the disease, presence of co-morbidity and duration of disease of the subject at the time of enrollment in the clinical trial should be the main criteria for deciding the quantum of compensation in the cases of serious adverse events (SAEs) of deaths occurring during clinical trials.
As per the new formula, the compensation amount will vary from a minimum of Rs. 4 lakhs to a maximum of Rs. 73.60 lakhs depending on the age of the deceased and the risk factor. However, in case of patients whose expected mortality is 90 per cent or more within 30 days, a fixed amount of Rs. 2 lakh should be given.
On consideration of the age of the subjects, the committee suggested that the 'The Workmen Compensation Act' may be applied for considering the age of the subject while calculating the amount of compensation in case of clinical trial related death. The rationale for taking the age factor as per the Workmen Compensation Act is that both are in general “No Fault Compensation” and the committee felt that both the situations are comparable so far as age factor is concerned.
After detailed discussion, the expert committee decided that the risk factor shall be divided in a scale of 0.50, 1.0, 2.0, 3.0 and 4.0. However in case of patients whose expected mortality is 90 percent or more within 30 days, a fixed amount of Rs. 2 lakh may be given. The five grade of the scale is divided as 0.50 is terminally ill patient (expected survival not more than (NMT) 6 months); 1.0 is patient with high risk (expected survival between 6 to 24 months); 2.0 is patient with moderate risk; 3.0 is patient with mild risk; and 4.0 is healthy volunteers or subject of no risk.
During the deliberations, the expert committee felt that the criteria used to determine the quantum of compensation should not be discriminative in nature due to socio-econimic conditions like income and education, and it should not discriminate gender/sex. The criteria should not be such which may have minimal impact but may create large variability and the formula should be such that the inter group variability of compensation value so arrived at, has little scope of discretion, thus avoid possible bias.