Expressing concern over deaths and serious injuries to patients during clinical trials of new chemical entities, the Supreme Court on Monday asked the government
to ?compel? the sponsor companies of such trials
to pay compensation to the affected.
?Why don’t you (government) compel the sponsor (of clinical trials of new chemical entities) to pay compensation to people who are seriously affected. They may have suffered more than death (during clinical trials),? a bench headed by Justice RM Lodha said.
Underlining the importance of timely compensation to such people, it said that ?you as government should act as a facilitator.
If you don?t have to pay (the compensation), then see to it that the sponsor (of clinical trial) pays. We don?t know the suffering that seriously affected patients are facing.?
Asking the government to be a facilitator in making of payments and later recovering them from MNCs who sponsored such trials, it said that a committee should be set up to ensure compensation to all those who suffered during clinical trials in 2005 or 2006.
?They just can?t remain waiting for seven to eight years. This is an admitted position that emerges from your affidavit,? Justice Lodha told additional solicitor general Siddharth Luthra. Having told the government to be sensitive towards timely payment of compensation, the court said that before any approval for conducting clinical trials was given, the government should see that it satisfies three parameters of ?risk versus benefit to patients, innovation vis-a-vis existing therapeutic options and unmet medical needs in the country.?
Earlier, the court had asked the government to put proper safety mechanisms in place before commencement of clinical trials with regard to new drugs/chemical entities. Besides, the apex court also asked the ministry of health to place before it the existing regime which ensures safety of subjects on whom trials are conducted and ?avoidance of serious or adverse events.?
