The Hindu Business Line : Insurance cover for patients in clinical trials mooted

AS safety-catches are being put in place to protect the "human subject" on whom a medicine is tested by a drug company — a silent demand is building on insurance companies to formulate schemes to cover clinical trials.

"How much will a drug company support a patient who has allowed the clinical trial of a medicine on himself? And will the coverage be a general insurance or for life, given the long-term risk of testing a medicine? What happens if research ends in litigation? Does the patients' support suffer because it is difficult to establish that the drug trial is responsible for the illness suffered by the human-subject?" queries a principal investigator, illustrating the potential pitfalls in protecting a patient who participates in a clinical trial.

"Insurance coverage for participants in a clinical trial is a new concept in India. And insurance companies are amenable to this idea only recently. They are not sure how to protect and how far to go," accepts a top-official with the Indian Council of Medical Research (ICMR).

The official adds, "ICMR's ethical guidelines talk about possible insurance coverage and we are insisting on insurance coverage on specific instances, while giving clearance for Phase I trials (the first step in human testing of a new drug)."

"Informed consent from the person participating in a trial and insurance coverage are included in the drug trial proposal submitted to the ethical committee of the institution undertaking the research," says Dr Mridula Phadke, a consultant with United Nations Children's Fund (UNICEF) and principal investigator on clinical trials.

"For any company doing meaningful research, such initiatives are taken in the interest of human rights," she adds. Dr Urmila Thatte, Head, Department of Clinical Pharmacology, Nair Hospital, agrees: "The patient should not be left in the lurch. Someone has to pay, the sponsor, the drug company or the insurance company."

Meanwhile, Dr R.K. Kaushik, handling health insurance at New India Assurance Co Ltd, told Business Line that "currently, there is no policy in the country to cover clinical trials per se." He points out, "It is difficult to make an assessment, for instance, in a new medicine, where the risk is not known. Nevertheless, drug companies do take some sort of a liability cover. A medi-claim for specific illnesses may be taken for people participating in trials on medicines whose safety profile has been established abroad."

"Insurance is not compulsory in India. But companies take coverage, in case of future litigation. There are few Indian companies who do offer coverage, but it is yet to get as popular as it is abroad. Patients are completely covered, even for incidents not related to the drug, for up to a month after the research," says a researcher with a multinational drug company.

But what happens in the case of long-term or unforeseen effects of a medicine that was tested? "At present, the law courts are the only recourse for patients in such cases," observes an insurance company representative.

More Stories on : Pharmaceuticals | Health | Insurance

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page

Stories in this Section
AI proposes more flights to US, UK

Interest costs rise for 460 firms in first half

Forex reserves surge by over $1 b

ONGC petro retailing plan in full swing

Insurance cover for patients in clinical trials mooted

Israel's LLD Diamonds to set up shop here

BILT on brownfield expansion drive; eyes high-value segments

CLB stays its order on Ketan Parekh Group cos