New Delhi, 21 October 2011 – People living with hepatitis C, ITPC-India and treatment activists at a press conference openly questioned the silence maintained by the Indian Health Ministry on its response to the Hepatitis C virus (HCV), which is emerging as a growing public health threat.
Currently, HCV treatment is a combination of two drugs, pegylated interferon and ribavirin. For people who do not clear the virus spontaneously from their body and go on to develop chronic forms of the disease that affects the liver, treatment is currently unavailable in the public healthcare system and unaffordable in the private sector.
The high cost of HCV treatment in India is attributed to the absence of generic competition due to patent barriers. India, as part of its obligations under World Trade Organization’s (WTO) international trade rules, had to introduce product patents on medicines in 2005.
Pegylated interferon alpha 2a and alpha 2b, used in the treatment of Hepatitis C, were among the first set of drugs to come under patent monopoly in India. The patents granted by the Indian Patent Office to two pharmaceutical companies – Roche and Schering Plough, block the development of more affordable generic versions of the drug. As a result both these companies charge exorbitant prices from patients, ranging from Rs. 14,000 to 18,000 per dose.
“People living with HIV are increasingly being diagnosed with HCV co-infection. Hepatitis C, is the “silent killer,” threatening to undermine HIV treatment efforts”, said Loon Gangte, of the Delhi Network of Positive People (DNP+). “We need not only AIDS medicines but also access to HCV medicines from the government.”
“I had to use all my savings and borrow heavily to pay over seven lakhs rupees for my 48 week HCV treatment, “ said Nanao Haobam, sharing his experience of living with HCV/HIV co-infection. “The Indian Government’s silence on this issue is more like telling us – I am sorry you will die because treating you is not cost effective.”
Neini Wanda E. Pakma, who underwent HCV treatment this year, adds, “my family had to pay Rs. 5,78,000 over 24 weeks for just pegylated interferon. I am one of the lucky ones to have been successfully treated in India. The high cost of drugs makes it impossible for patients in India with chronic HCV to get the treatment they need.”
“As a physician we have gone through the frustration of watching people die of AIDS even when effective antiretrovirals existed. But things changed with domestic production of affordable generic antiretroviral medicines,” said Dr.Tokugha Yepthomi, of ITPC – India. “People are now dying because the price of the HCV drug that can save them is too high. Prohibitive pricing of lifesaving medicines by pharma companies is unethical and unacceptable.”
According to the organisations, the government has been moving far too slowly on addressing the problems of patients who need HCV treatment. “When drugs are patented, and pharmaceutical companies fail to fulfil their obligation to make patented medicines available and affordable to patients, the only way to bring prices down is through examining the validity of the patent granted or compulsory licensing which allows generic production of more affordable versions,” said Loon Gangte. “Instead of addressing the problem, it’s like the government is pretending the death and the sickness that HCV causes are not happening.”
Patents on pegylated interferon: High prices due to the introduction of WTO’s product patent regime in 2005 are starting to be experienced in India. On March 3rd 2006, Roche proudly announced it was becoming the first pharmaceutical company in India to receive a product patent under the new patent regime on peg-interferon alfa-2a (IN198952). Sankalp Rehabilitation Trust filed a post grant opposition to the patent in 2007, as the technology of combining interferon and other biologically active proteins with PEG has been known for years prior to the patents. The matter will be heard before the Intellectual Property Appellate Board in January 2012. Schering-Plough was granted a patent (IN 207233) on peg-interferon alpha-2b and has filed infringement suits in 2009 against Virchow Laboratories and Ranbaxy before the Delhi High Court. The infringement suit is scheduled to be heard next on 15 December 2011.