Why no compensation for seriously affected medical trial patients

Clinical Trials

The Supreme Court on Monday called on question the Central government’s inaction when it came to huge pharmaceutical companies, who often act as sponsors of clinical human drug tests, not compensating those participants of the drug test who had suffered adverse effects from it. Human clinical tests are the last step before the drug is ready for sale to the general public. As they are untested on humans before, the medical trial patients of such clinical trials run the risk of suffering many often unrelated serious side effects from the drug.

The bench, consisting of Justices R M Lodha and Kurian Joseph, was deliberating upon a PIL submitted by an NGO, the Swasthya Adhikar Manch, which claimed that “Indians were used as guinea pigs” by big multinational pharmaceutical companies. According to figures presented by the NGO from government sources, out of 57,303 participants to various trials, only 39,022 completed them.

Appearing on behalf of the government, Additional Solicitor General Sidharth Luthra in his rebuttal said that out of the total clinical trials held in the period, 2,644 participants suffered serious adverse effects, out of which 80 deaths were attributed to complications resulting directly from the clinical trials. He added that families of all the 80 patients had been compensated by the sponsors.

However, the bench was focussing on the part of Luthra’s statement that out of the total participants of the clinical trials, around 11,972 faced side effects, excluding death, out of which 506 cases were as a direct result of the clinical trials.

The court in its statement asked as to why the Government had not ensured that participants who suffered adverse effects from clinical trials were not compensated by the sponsors of the test, as they might have in fact suffered more than those who died.

Luthra at this point conceded that this aspect of the matter had not been looked in at by the Ministry, and asked for eight weeks to form an official government response.

The Court also suggested the government to put out advertisements seeking out the patients who suffered as a direct result of the clinical trials, so that the matter could be dealt with quickly.