CNS: Costly medicines mean DEBT or DEATH for people with chronic hepatitis C

[To download or read the report online, click here]
A new report to be released on World AIDS Day, by International Treatment Preparedness Coalition (ITPC) India (download here), has questioned the silence maintained by the Indian Ministry of Health and Family Welfare on its response to the Hepatitis C virus (HCV), which is emerging as a growing public health threat. According to the World Health Organization, hepatitis C virus (HCV) is a major cause of acute hepatitis and chronic liver disease. Globally, 3 to 4 million persons are newly infected each year. The burden of the disease in India will continue to rise in the absence of prevention and harm reduction measures with vulnerable communities.

"HIV and hepatitis viruses are transmitted in similar ways and it makes public health sense to link HCV prevention efforts to HIV programme" said Naresh Yadav, Chair of ITPC India. "In addition to HCV screening in blood banks, prevention and harm reduction efforts for HIV and HCV with vulnerable communities should go hand in hand. Unless this is done, HCV infections will rise in India even though HIV transmission rates reduce, particularly among injecting drug users (IDU), the most vulnerable community," said Naresh Yadav.

According to this report, there are two main obstacles to an effective HCV response in the country. First is the absence of prevention efforts; second is the lack of political will to treat HCV-among policymakers in the Health Ministry.

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 Naresh Yadav. "We need not only AIDS medicines but also access to HCV medicines from the government. 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” said Naresh Yadav.

According to this report, 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. Instead of addressing the problem, it's like the government is pretending the death and the sickness that HCV causes are not happening.

The ITPC India members had also met officials and Chairperson of Health Committee of Planning Commission of the Government of India earlier in October 2011 and provided them with meeting documents for consideration to be fed into the next five year plan (12th FYP: 2012-2017).

The ITPC India report makes the following key recommendations:
1. Include Hep-C in surveillance system
2. Initiate Hep-C testing through current ICTCs with proper pre- and post- test counselling
3. Provide free Hep-C treatment to people where medically it is indicated
4. Government must integrate a comprehensive and well-coordinated Hep-C programme within the National AIDS Control programme at NACO as both HIV and HCV interventions are going hand in hand and will maximise AIDS programme performance as well as save lives from Hep C
5. Phase out toxic Stavudine (d4T) from India’s ART programme
6. Expand second-line ART coverage and initiate third-line ART in current ART programme and guideline
7. Remove SACEP criteria from countries ART programme