Modi govt frames compensation formula for J&J by tweaking India’s clinical trial rules. Now, upper limit is likely to be set at over Rs 1 cr.
New Delhi: The Modi government is likely to direct American pharmaceutical major Johnson & Johnson to pay compensation to patients affected by the firm’s ‘faulty’ hip implants based on a ‘tweaked’ version of the compensatory formula that the government adopts for deaths and injuries during clinical trials.
The central expert committee, constituted by the Health Ministry to decide on the compensation, has arrived at a formula based on the Clinical Trials Rules, 2018, ThePrint has learnt.
“We have made changes to the already legitimate clinical trials rules. The formula is legally accepted, simple and transparent,” said a member of the central committee.
While under the clinical trial rules the base amount in case of death or injury is Rs 8 lakh, for Johnson & Johnson, the government is likely to push it up to Rs 20 lakh. This will increase the quantum of compensation.
The formula considers three variables — base amount, the age of the patient and severity of the disease at the time of enrolment.
“Based on this, the minimum compensation would be anywhere between Rs 30 to 35 lakh,” said the central committee member. “The maximum compensation, which is in case of death, under the clinical trial rules is Rs 74 lakh. It has been jacked up to above Rs 1 crore.”
Also read: Johnson & Johnson, Modi govt at odds over compensation for faulty hip implants
The Central Drugs Standard Control Organisation (CDSCO) has sent the formula to the Ministry of Health and Family Welfare for the final approval.
“We are expecting ministry to clear the formula within the next 10 days,” said another senior official from the Ministry of Health. “After the clearance, we will upload the formula on the CDSCO website so that patients can understand and calculate their compensation amount themselves.”
The development comes in the backdrop of more than 30 patients writing to Union Health Minister J. P Nadda this month, raising concerns on the lack of transparency and patient consultation in the process to decide compensation.
Johnson & Johnson has refused to comment on the latest development. Its spokesperson referred ThePrint to the company’s earlier statement on the compensation issue.
“As a company that has been dedicated to the advancement of patient health in India for 70 years, and in line with our ongoing commitment to ASR patients, we are committed to assisting the Expert Committee who is developing a process for providing further support and compensation for ASR patients,” the earlier statement read.
“This is with the goal of ensuring adequate resources are in place to assess each patient’s case and ensure that each person receives the appropriate level of support under the program.”
How the formula is likely to work
In the event of a death, under clinical trial rules, the formula considers the three variables in which severity of the disease at the time of enrolment is measured on a scale of 0.5 (terminally ill patient) to 4 (healthy volunteer).
While the base compensation amount has been increased to Rs 20 lakh, the government is now likely to introduce changes in the calculation of the severity of the disease or it might introduce another variable to replace this component.
“Under clinical trials, if a terminally ill patient dies, the compensation amount is less as the death was already inevitable or was expected to happen in another six months or so,” said the official from the committee.
“Under the hip implant replacement, a terminally ill patient or patients with higher chances of death won’t be prescribed surgery. Hence, this component will be used for a different purpose in the new formula.”
The official also said the compensation will take into account the future living costs of the patients.
“Patients won’t feel let down by the penalty amounts,” the official said. “For compensations other than death, if a person underwent a surgery when he was 60 years or above and the disability is measured at the bottom of the scale, the minimum compensation will be within Rs 30 to Rs 35 lakh.”
Also read: Hip implants dent brand Johnson & Johnson, patients begin questioning other devices
What next?
If J&J does pay aid, it will be the first-ever instance of compensation being paid for substandard treatment in India.
Under the present legal provisions in India, the American company cannot be compelled to pay the compensation.
“The Drugs and Cosmetics Act provides for compensation in very limited circumstances such as faulty clinical trials or for the supply of spurious, adulterated, sub-standard drugs,” Shamnad Basheer, professor of law at the National Law School, Bengaluru, had told ThePrint earlier.
“These provisions cannot apply to faulty medical devices such as J&J’s ASR hip implant
since such implants cannot qualify as ‘spurious’ or ‘adulterated’ or ‘sub-standard’ under the terms of the Act and corresponding rules or guidelines,” he had said.
The government had earlier said J&J has “put in writing” that it will pay compensation as decided by an expert committee but the company had remained non-committal on if it had done so.
Moreover, the government has only managed to trace 125 people fitted with J&J’s Acetabular Surface Replacement (ASR) hip implant for compensation against the reported 4,700 affected patients.
“A big question is what the government is doing to do to trace these over 4,000 patients,” said Malini Aisola of the public health group, All India Drug Action Network (AIDAN). “The process of arriving at a formula is also taking place behind closed doors and is lacking in transparency. No stakeholders were consulted.”