Drug companies looking to test their experimental drugs on Indians will
not find human lives cheap any more. According to an amendment to the
relevant law being planned by the health ministry, the onus of proving
that clinical trials did not cause death or injury will now lie with the
drug company concerned. Further, in case of death or injury from such
trials, the company will have an explicit legal obligation to
financially compensate the victims.
Currently, India has no clear, enforceable law that mandates 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.
According to sources, the health ministry is set to mandate payment
of compensation to volunteers participating in clinical trials in case
of a trial-related death or injury by amending the Drugs and Cosmetics
Rules.
“Under the proposed rule, it would be the responsibility of the
trial sponsor on behalf of the pharma company to prove before the ethics
committee that the injury or death is not on account of clinical trial
within 30 days of receiving the report of the injury or death from
investigator, failing which the sponsor shall be liable to pay the
compensation within 60 days or as decided by the ethics committee,” a
health ministry official said. The amount of compensation will be
decided on a case-to-case basis by the ethics committee.
The Drug Controller General of India’s (DCGI) office has already proposed the policy changes to make
drug companies and other agencies accountable in conducting clinical
trials. Further, the Drug Technical Advisory Board (DTAB), the highest
decision-making body on such matters, has also endorsed the proposal to
make companies liable to duly compensate people suffering from trial
related injuries. The DTAB, however, added that DCGI should also
consider the feasibility of setting up a tribunal comprising physicians,
retired judges and civil society members to decide on disputes and fix
the minimum compensation. Also, the time-frame for claiming compensation
could also be determined, the board suggested.
The health ministry move follows an investigation earlier this 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 an
explanation. When the DCGI summoned some of these firms to explain
their cases in June, they reportedly opted to pay up.
While most drug companies which FE contacted refused to come on
record on the issue, saying it would be inappropriate to comment on a
law which is still in the making, three MNCs said they adhered to
internal protocols to decide the compensation once it is proven that a
death or injury resulted from the trial and most cases of alleged
non-payment was due to oversight of ethics committees. One of them,
however, objected to the move to shift the burden of proof to the
companies. “There are times when terminally ill patients enroll
themselves for such trials after intimation from doctors about the
seriousness of their illness. In those cases, it may become very difficult for us to
establish a causal relation (between the clinical trials and the death
of the patient).”
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.
