India will soon quantify the amount of compensation to be paid by
pharmaceutical companies, if a volunteer dies or gets injured during a
clinical trial.
On October 10, the Drug Technical Advisory Board (DTAB) gave its nod to
the Central Drugs Standard Control Organization (CDSCO) to prepare a
"compensation chart" or extensive guidelines that will specify the
amount to be paid.
Ethical committees of the company will have to decide the quantum of
compensation on the basis of these guidelines.
The compensation has to be paid by the trial's sponsor or its
representative within 90 days of the death or injury to the victim or
the next of h/his kin. In the first 30 days, the firm will have to prove
to the ethics panel that the death or injury wasn't due to the drug,
else it has to pay.
In India, pharma companies pay compensation "according to their will"
that varies between Rs 1 lakh and Rs 10 lakhs since "no set parameters
have been laid down".
The CDSCO will prepare the compensation guidelines after consulting the
Motor Vehicles Act, Railways and the Workers Compensation Act.
Union health ministry officials say it will take another three months to
notify the guidelines. "When a 70-year-old terminally ill patient dies
during a clinical trial, the compensation should be less than that given
to a 22-year-old in the first stage of the same ailment. The youngster
could be the family's sole bread-winner and would have lived longer had
it not for the adverse drug reaction.
The guidelines will quantify who
should get how much compensation," a ministry official told TOI.
"Both these patients could get the same amount. However, the pharma
company might have decided on an abysmally low package. Once the
guidelines are in place, the division of compensation will be fair," he
added.
Families of the 22 clinical trial victims last year were paid around Rs
50 lakh by 10 pharma companies.
Compensation ranged from Rs 1.08 lakh to Rs 10 lakh. Most of the
families received Rs 1.5 lakh and Rs 2.5 lakh as a one-time package.
Initially, the companies had not paid compensation for majority of these
deaths. Then, DCGI Dr. Surinder Singh issued an ultimatum to the errant
firms: pay up or all other trials would be suspended.
The companies who paid the compensation included well-known names like
Wyeth, Quintiles, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and
Pfizer. Pharma companies have all along been blamed for not paying
compensation to hapless clinical trial victims.
The Indian Council of Medical Research recently framed draft guidelines
for compensation to participants for research-related injury. Mothers,
who because of clinical trials, lose or cause harm to their unborn child
may be able to demand compensation from researchers conducting the
trials.
Compensation has to be paid, irrespective of whether injury was
foreseeable/predictable, and that the research participant had freely
consented in writing about participating in it.
Compensation will have to be provided to the research participants when
temporary or permanent injury occurs due to participation in the
clinical study.
Compensation also has to be paid when the injury is caused by a
procedure that has been undertaken to manage an adverse reaction
occurring during the research.
Defining "compensation", the draft says it could be in form of payment
for immediate medical/surgical management of research-related injuries,
compensation for research-related injuries leading to temporary or
permanent disabilities or compensation to legal heir/lawful guardian in
case of death.
"The payment will be the responsibility of the
investigator/institution," it says.
Besides, the Informed Consent Document (ICD) will have to state that the
research participant has the right to claim compensation in case of
research-related injuries and whom to contact for it.
