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Pharma cos need to compensate clinical trial victims, rules govt

Pharma cos need to compensate clinical trial victims, rules govt [Financial Express (India)]

From Financial Express (India) (February 3, 2012)

The government has made it mandatory for pharmaceutical companies sponsoring clinical trials in the country to pay financial compensation to volunteers in case a trial-related death or injury is proved. Moreover, the onus of proving that clinical trials did not cause death or injury will now lie with the drug company, according to a recent notification of the health ministry.

Failure to pay up the compensation within a specified time may not only lead to suspension or cancellation of the ongoing trials, but in more severe cases, may also result in a permanent ban on the pharma company and the clinical research organisation (CRO), barring them from conducting any further trials in the country. The amount of compensation will be decided on a case-to-case basis by the ethics committee, while the quantum of minimum compensation would already be mentioned in the informed consent form that the pharma company needs to get signed by the volunteer, before enrolling the subject into a trial.

FE was the first to report in August that the government would make it an explicit legal obligation for pharma companies to pay up in case of a death or injury of the volunteer in his trial participation period and the burden of proof in such a scenario would lie with the drug firm sponsoring the trial.

Till now, India had no clear, enforceable law mandating a drug company to provide financial compensation to the affected party or his or her dependents in case of injury or death during clinical trials. Neither the Indian Council of Medical Research's Ethical Guidelines for Biomedical Research nor the Good Clinical Practices guidelines that deal with the subject have the status of law. These guidelines spell out the obligation of the trial sponsor in case the participant incurs physical or psychological injury, but do not delve into how to deal with complications that might arise in such cases.

"In the event of an injury or death occurring during the (clinical) trial, the sponsor or his representative shall prove before the ethics committee that the injury or death is not on account of the clinical trial within 30 days of receiving the report of injury or death from the investigator, failing which the sponsor shall be liable to provide the compensation within 60 days," says the new health ministry notification.

After a serious adverse event is reported during the trial, the pharma firms or their CROs must pay the required compensation and report the details of such action to the drug regulator within 90 days of the reporting of the side effect. The amount of compensation would be recommended by the ethics committee in the first place. If the pharma company doesn't agree with the amount or terms of payment, it may seek a review of the matter by the ethics committee, whose decision would be final. If the pharma firm is still dissatisfied with the verdict, it can seek legal recourse.

The health ministry's move follows an investigation last year by the ministry which found that most firms undertaking clinical trials had not paid compensation to the relatives of the persons who died during the trials. Of the 671 reported deaths during clinical trials in 2010, compensation was paid only in three cases. Subsequently, the ministry sent show cause notices to over 40 drug firms including Pfizer, Bayer, Novartis and Eli Lilly seeking explanation. When the drug controller general of India summoned some of these firms to explain their cases in last June, they reportedly opted to pay up.

The Indian clinical research market is estimated to be between $300 to $500 million in 2010. The Indian clinical trial market which offers 30-40% savings to pharma companies compared to the US and EU (E&Y estimate of 2005), is projected to grow annually at a rate of 20%, according to Visiongain, which sees it becoming one of the most-favoured clinical trial destinations along with China by 2015.

Copyright 2012 The Indian Express Online Media Pvt. Ltd., distributed by

Credit: Soma Das


Posted: February 2012