Indian patients go to court over cancer drug
Ganapati Murdur

New Delhi

India's Supreme Court has admitted a petition from an organisation representing cancer patients that challenges the government's decision to grant Novartis the exclusive marketing rights for imatinib, a drug that has emerged as a frontline treatment for chronic myeloid leukaemia.

The petitioner, the Cancer Patients Aid Association, has said that exclusive marketing rights for the drug would eliminate cheaper generic versions of the drug and make the treatment unaffordable to thousands of patients in India.

"Shutting down access to the drug by making it unaffordable is tantamount to denying patients the right to life," said Mr Yogendra Sapru, the association's chairman.

Although Indian laws do not permit product patents on drugs, the Indian patents office has granted Novartis exclusive marketing rights for imatinib under the provisions available in an international trade agreement on intellectual property rights signed by India.

The company's product, Glivec, is a crystalline form of imatinib mesilate, a compound that blocks a specific protein implicated in chronic myeloid leukaemia. The drug has been approved for this cancer in the European Union and in more than 60 countries.

When Novartis introduced Glivec in India in May 2002, several Indian drug companies began to produce generic versions of the compound. But after Novartis received exclusive marketing rights last November, local manufacturers have had to stop selling the generic versions.

"The cost of a month's dose of Glivec is 120 000 rupees [¢G1400; $2600; 2100], 10 times higher than what the generic versions used to cost patients," said Mr Sapru. "The overwhelming majority of patients in India do not have this kind of money."

A spokeswoman for Novartis India said that more than 2380 patients in India currently receive the drug free under the Glivec international patient assistance programme. "No patient who requires Glivec and meets medical and economic criteria for inclusion into the programme is denied the drug," she said.

She said that oncologists and haematologists in India were familiar with the procedure for enrolling patients into the programme. Patients who were not insured and who had no funds to draw on were eligible for the programme.

However, doctors say that patients have been affected by the lack of generic versions. "Dozens of patients have had to stop treatment after the generics went out of the market," Dr Purvish Parikh, head of the department of medical oncology at the Tata Memorial Hospital, Mumbai, said.

The association has petitioned the court to direct the government to impose a price control on the drug. Experts in international trade law say that the government has the authority to fix prices despite the grant of exclusive marketing rights.

"The international trade agreement and Indian laws allow the government to take steps to protect the health of its citizens," said Sourirajan Srinivasan, managing trustee of LoCost, an organisation that has been tracking drug pricing practices and producing cheap generic drugs for the domestic market.

"The real question is whether the government is willing to act."