Victims too: Children demand charitable treatment

For the 46-year-old school teacher in Mumbai with blood cancer, it feels as if a lifeline is about to be wrenched away. For six months now, says an acquaintance, he’s been taking a new drug. His blood counts have improved and he feels better. His doctors have told him that while it is impossible to predict its long-term impact, the drug appears to be fighting his cancer better than anything else he’s taken. Produced by a local company, it costs about Rs 6,000 a month. But, the drug may soon not be available any more — a consequence of pharmaceutical battles — and the only option, then, will be an imported brand from the global giant Novartis that may cost Rs 1,20,000 a month.

“It’s an unthinkable option, way beyond his reach,” says Alka Kapadia, executive director, Cancer Patients AIDS Association (CPAA), a non-government organisation in Mumbai, which supports treatment costs for needy patients. “He’s among many patients worried about what they’re going to do,” she says. Ten months ago, India’s controller of patents granted Novartis exclusive marketing rights (EMR) for a drug called Gleevec, heralded by some as a “breakthrough” therapy for chronic myeloid leukaemia (CML), a cancer of white blood cells. India does not recognise product patents on pharmaceuticals. This allowed local drug companies to produce the same compound through different chemical processes and to sell it under different brand names.

However, until India changes its patent laws to cover pharmaceutical products, a company may apply for and get EMR for a specific product — as did Novartis for Gleevec — and prevent competitors from selling the same compound under other brand names. With Novartis acquiring EMR, the local manufacturers may soon be prevented from selling their relatively low-cost versions of the drug sold under different names.

Now, the CPAA has filed a petition in the Supreme Court challenging the EMR and seeking government action to make the drug available cheaper. The petition says that the absence of low-cost versions of the drug would mean denial of the right to life enshrined in Article 21 of the Indian Constitution. In a 1987 ruling, the Supreme Court had expanded the term ‘right to life’ to include the right to health.

Health activists and pharmaceutical patents specialists say that the petition from the CPAA may evolve into a benchmark case where India’s obligations under international trade agreements are pitted against the right to health for the nation’s citizens. “We’re asking whether profit is more important than human life,” says CPAA chairman Y. K. Sapru.

There were nine Indian companies making the drug. But after the EMR, the Madras High Court issued an injunction against six of them preventing them from doing so. Another petition against a major producer of the drug is lying with the Bombay High Court.

Doctors say there are hundreds of other patients with CML who may have to stop treatment because the low -cost drugs are hard to get.

Novartis says that Gleevec is an original research product that involved significant investment and is thus more expensive than the locally manufactured copies of the compound. Novartis also says that Gleevec is offered free of charge to needy patients. “Patients who meet medical criteria and are not insured or reimbursed and have no financial means are eligible for treatment free of charge,” a Novartis spokesperson said. “No patient who requires Gleevec and meets the medical and economic criteria is denied the drug. To date, there are 2,382 patients in India who receive Gleevec free of charge,” she said.

Drug industry-watchers say that more such pharmaceutical disputes may emerge in the future after product patents get recognised in India. A pharmaceutical company granted a product patent on a drug could have an effective monopoly over the market. But experts say that if the government wants to, it could impose price controls on drugs even if they are granted exclusive marketing rights, or product patents in the post-January 2005 era.

The government can empower itself with the right to issue compulsory licences on patented drugs to local manufacturers to be made available at lower prices,” says Amit Sengupta, an official with the People’s Health Movement, a coalition of non-government health organisations, and a co-convenor of the National Working Group on Patents which has been examining the implications of amended patent laws. Compulsory licensing would allow non-patent holders to produce a drug. “Compulsory licensing can be invoked on certain grounds such as national emergency or extreme urgency or if the government feels that prices of a product are too high or if the medical needs of its citizens are not being met,” says Sengupta.

India can also invoke another international agreement — the International Covenant on Economic Social and Cultural Rights — to safeguard the right to health for its citizens. The Covenant makes it obligatory for member states to help its citizens attain the highest possible standard of health — and one way to achieving that would be by controlling drug prices.