The Supreme Court’s decision to deny Novartis a fresh patent for its anti-leukaemia drug, Glivec/Imatinib, has been hailed as a move that will bring life to generics. Medical oncologists fete it for another reason: If the judgment had gone any other way, the existing generics in the market would have to disappear.
The primary implication for users of the drug (from Monday’s judgment) is that it will now be available at a much reduced price.
But then, doctors point out: it is already available at a reduced price. “Over the last six years or more, we have been prescribing generics to our patients,” says Ganapathy Ramanan, medical oncologist, Madras Cancer Care Foundation.
Rejiv Rajendranath, Associate Professor, Medical Oncology, Cancer Institute Adyar, says generics have been available in the market for many years at least from 10 different companies. The product, from any of these companies, costs between Rs. 8000 and Rs. 10,000 a month.
“These generics are available about a tenth the price of the Novartis branded drug,” Dr. Ramanan, adds. The timing (of introduction of generics) hangs in with the initial rejection of the Novartis patent for its new molecule — the Assistant Controller of Patents first said ‘no’ to the company in January 2006.
“Generic versions are also available at all government hospitals, and are covered under the Chief Minister’s Health Insurance Scheme in Tamil Nadu. If this judgment had come way back in the late 1990s it would have been really huge. Since 2002, Novartis has been providing it free under its Glivec International Patient Assistance Programme (GIPAP) along with the Max Foundation,” explains Revathi Raj, paediatric oncologist. While chronic myeloid leukaemia (CML), which the drug treats, is largely seen among adults, there are children who are being treated with Imatinib, she says.
Dr. Ramanan says that over the years, GIPAP has emerged as assistance based on income slabs and ability to pay. While patients will benefit with the recent judgment, it will be because the generics will stay. “If you look at this aspect, it is a boost for generics in general. If the Supreme Court had upheld the patent this would have deterred the Indian companies from producing cheaper generics in general,” Dr. Rajendranath adds.
As per the statistics provided in the website of Max Foundation: the number of patients who have received free Glivec through GIPAP is 56,637. In India, the number of patients who have benefited is 16,500. The Cancer Institute, Adyar, has around 900 patients under the programme, Dr. Rajendran says.
No wonder then that Novartis, despite the joy a judgment against it has produced, enjoys a certain pride of place in a medical oncologist’s clinic. V. Shanta, chairperson of the Cancer Institute, says, “I must acknowledge the contribution of GIPAP and the Max Foundation; they have been providing Imatinib completely free of cost to our patients. Of course, the ‘enhanced one’ is not available for free distribution.”
“Generics are also covered under health insurance. And this has helped a good portion of the patients access Imatinib. We are not against generics, because affordability is a key aspect of health care treatment. Generics make drugs available to people who cannot afford patented products,” Dr. Revathi says.
Dr. Rajendranath explains that the only way to bring down costs of drugs is to bring in a more stringent and uniform pricing policy for innovative and patented drugs in India. “The pricing should be fixed based on our paying capability and not the exorbitant global costing. Also, it may help if more big companies open up patient support programmes, especially for life-saving medicines.”