Under the proposed law, the onus of proving that clinical trials did not cause death or injury, was expected to lie with the drug company. Failure to pay up the compensation within a specified time would have not only led to suspension or cancellation of the ongoing trials, but in more severe cases could have resulted in a permanent ban on the pharma company as well as the clinical research organisation (CRO).
The amount of compensation was to be decided on a case-to-case basis by an ethics committee, while the quantum of minimum compensation, according to the draft, was to be mentioned in the informed consent form that the pharma company gets signed by the volunteer before enrolling him for a trial. The industry, which has had two rounds of discussion with health ministry on the matter, claims that there are too many loose ends in governments plan.
Firstly, the members of the ethics committee, comprising lawyers, policemen and one or two clinical pharmacologists, are neither qualified nor ready to take up this task of establishing causality of death, the head of a multinational CRO told FE.
We have suggested that in case of a dispute on the cause of death or permanent injury between investigator (conducting clinical trials) and sponsor (pharma companies), an expert committee comprising clinical pharmacologists and independent experts should be instituted to determine whether that is a result of the new product administered. We are also demanding that the amount of compensation be standardised on the basis of precedents, he said.
Eminent drug regulatory expert CM Gulhati feels the compensation rules in the Motor Vehicle Act can serve as a basis to determine the amount of compensation but other parameters such as age of the volunteer, number of dependents, prevalent morbidity cannot be discounted to standardise such payments. Ficci has submitted that financial compensation be restricted to cases of death and permanent injury which results only from the products being tested.
One of the purposes of any clinical trial is to establish the effectiveness of the drug. Failure of intended therapeutic effect cannot be a pre-condition placebos are used to evaluate the effect of a drug in conditions that have no proven effective treatment and are not expected to provide any therapeutic benefit, the Ficci document reasons. Gulhati, however, disagrees. When you administer placebo to a volunteer in clinical trial, you are not telling him that. You are still enrolling him with a promise that he stands a good chance of benefiting from a new drug. In many cases, you are even taking him off another therapy. So, you cannot be absolved of paying compensation in this category, he said.