New Delhi, Sept. 12: A government panel has proposed a mathematical formula that will guarantee compensation anywhere between Rs 2 lakh and Rs 76 lakh for deaths of participants in clinical trials, but experts have slammed the idea as “shabby”.
An expert committee set up by the Drugs Controller-General of India, the regulator of clinical trials, has pitched a formula that couples a base amount of Rs 8 lakh with the participant’s age and a risk factor value linked to the severity of the disease.
India has emerged as a major site for domestic and global clinical trials of candidate new drugs or vaccines or studies designed to compare the efficacy of existing drugs.
The Drugs Controller-General had approved 1,065 clinical trials during the three years from 2010 through 2012. But in the backdrop of a lack of regulations or uniformity, the issue of compensation for the deaths of participants in clinical trials has become a contentious issue.
The Union health ministry told Parliament earlier this year that 1,542 participants had suffered serious adverse effects and died during clinical trials between 2010 and 2012. Among these, 38 were “deaths due to clinical trials” and 37 had received compensation.
Almost all participants in clinical trials are ill and many are likely to die of their disease in the duration of the trial, anyway.
The expert committee has now proposed that the compensation be determined through a formula that takes into account the base amount of Rs 8 lakh with the age-factor based on the Workmen Compensation Act and the risk factor value.
Under this formula, the compensation will vary from Rs 4 lakh to Rs 73.60 lakh, depending on the age of the deceased and the risk factor value. But, the panel has also proposed that the compensation for the deaths of participants who were extremely ill and whose expected mortality was 90 per cent or higher within 30 days will be fixed at Rs 2 lakh.
“I think this is a most shabbily done exercise,” said Chandra Gulhati, a pharmacologist and editor of the Monthly Index of Medical Specialities, India, who has analysed clinical trials for many years.
“There is no mention at all of serious adverse effects that do not result in death, which account for 90 per cent of the cases. Merely treating them is hardly adequate — they too need to be compensated.”
The panel has relied on the Workmen Compensation Act to determine the age factor, which could range from 99.37 for the age of 65 years to 228.54 for a 16-year-old participant. It said the base amount chosen was intended to allow the participant’s nominee to receive a monthly interest at least approximately equivalent to the minimum wages of unskilled workers — Rs 7,722 per month.
But, Gulhati said, by failing to consider the income and the number of dependants of the deceased merely for simplification, the procedure becomes unfair and is likely to be struck down by the courts.
“This is likely to prevent well-off people from participating in trials, thus driving mainly poor and illiterate patients into clinical trials.”
Some critics also see the risk factor values as a problem. The formula assigns a risk factor value of 4.0 to healthy volunteers, 3.0 to patients with mild risk, 2.0 to patients with moderate risk, 1.0 to patients with high risk and 0.50 to terminally ill patients.
“This assumes that healthy volunteers need more money,” said Sourirajan Srinivasan, managing trustee of Low Cost Standard Therapeutics, a Baroda pharmaceutical firm.“So young people would be eager to be volunteers.”