More battles in store

April 07, 2013 12:11 am | Updated December 04, 2021 11:39 pm IST

Well before the Supreme Court rejected Novartis’ application for patent for Glivec (Gleevec in the U.S.), drawing attention to the dichotomy of generic and patented drugs, activists have been demanding access to expensive drugs used in the treatment of cancer, hepatitis C and serious HIV.

Trastuzumab is one such, used in the treatment of HER2+ type of breast cancer, which affects about one in four patients with the disease.

Rough estimates suggest one lakh women in India are diagnosed with breast cancer every year. One out of every 22 women is likely to get breast cancer. Breast cancer is now the most common type in urban areas, and the second most common in rural areas. Data from the Indian Council for Medical Research suggest some extremely worrying trends: breast cancer is becoming more common in younger women, with almost 50 per cent of patients under 50, many of them showing an increased incidence of HER2+, which is particularly aggressive.

Beyond reach

In 2006, the U.S. Food and Drug Administration approved Trastuzumab for treatment of HER2+ breast cancers. Treatment consists of approximately 12 intravenous doses, administered every three to four weeks over a year.

When this drug became available in India as Herceptin, it was priced at Rs.1,10,000 a vial, making it unaffordable to all except the very wealthy. In March 2012, soon after the decision of the Indian Patent Controller to grant a compulsory licence for Sorafenib (used in the treatment of liver and kidney cancers), Roche announced a cut in the Herceptin price, from Rs.1.08 lakh a dose to Rs. 92,000. Roche also signed a commercial agreement with Emcure Pharma. As of 2012, Emcure is offering a repacked and renamed version of Trastuzumab (Herclone) at Rs.72, 000 a dose — a cut of 33 per cent from the 2011 price.

Kalyani Menon-Sen (women’s activist), Leena Menghaney (lawyer), and Third World Network have written to the Prime Minister, appealing that Trastuzumab be made available free to patients in government hospitals, and at affordable cost in the open market.

They also demand constitution of a High-Level Inter-Ministerial Task Force in the Health Ministry, involving biotechnology experts from public-funded research organisations and civil society organisations, to address the technological issues in the production of Trastuzumab, and ensure that no secondary patents are granted for Trastuzumab or enforced in India.

Another group of health activists has demanded that the government either reject the patents given to hepatitis drugs or issue compulsory licences, as the Hepatitis C virus (HCV) is a growing public health threat . HCV treatment is unavailable in the public healthcare system and not affordable in the private sector.

Currently, HCV treatment is a combination of two drugs: pegylated interferon and ribavirin. The high cost of HCV treatment is attributed to the absence of generic competition.

“People living with HIV are increasingly being diagnosed with HCV co-infection. Hepatitis C is the silent killer threatening HIV treatment efforts,” says Loon Gangte of the Delhi Network of Positive People (DNP+).

Vikas Ahuja of Delhi Network of Positive People says, “We may have won the battle against Novartis but war lies ahead at European Union-India Free Trade Agreement. If India signs the FTA in its present form, it will virtually sign the death sentence for the patients.

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