Indian Health Ministry urged to begin providing Hep C treatment now, oppose patent on new Hepatitis C drug and demand affordable access
New Delhi, 21 March 2014 — With oral drugs promising to simplify and improve hepatitis C (HCV) treatment, the Indian Health Ministry should start rolling out treatment now for the millions of people waiting, said the Delhi Network of Positive People (DNP+) at a protest held today outside the premises of the Ministry of Health & Family Welfare.
“I have already endured HCV treatment, with painful injections and side effects, but I am still sick with the infection,” said Umesh Sharma, of Indian Drug Users Forum (IDUF). “Like many people who are chronically infected with HCV, I’m anxiously waiting for the government to start treatment with oral drugs. I do not want to die from a disease when effective oral treatment could be made available.”
The World Health Organization estimates that more than 12 million people in India may be chronically infected by the hepatitis virus, most of whom do not know they are infected. The number of people who are going to get sick or die due to HCV infection are expected to keep rising in India as infections incurred years ago increasingly take their toll. The complexities and costs associated with the current injectable treament, have acted as a deterrant for treatment providers and governments like India from investing in a Hepatitis C testing and treatment programme.
But, treatment is improving dramatically: potent oral medications, called direct-acting antivirals (DAAs), are dramatically increasing cure rates. New DAAs - including sofosbuvir approved by the USFDA in December 2013 and many others in late-stage development - can be produced generically in India and marketed at very affordable prices, just like antiretrovirals (ARVs) used in the treatment of HIV. For example, a twelve-week course of sofosbuvir, produced generically, is estimated to cost between US $130-US $270; daclatasvir, a highly effective drug from a different class, produced by BMS, may cost just US $10- $30 per treatment course.
Gilead Sciences, a US pharmaceutical company is expected to apply for Drug Controller General of India (DCGI) approval for sofosbuvir in the coming months.
“Now is the time to fight for affordable DAAs so that everyone who needs it has access to life-saving HCV treatment,” sais Vikas Ahuja, President of DNP+.
Although Gilead has applied for multiple patents on sofosbuvir in India, the country’s intellectual property laws are strict about what does and what does not deserve a patent.
This week, DNP+ and Initiative for Medicines Access and Knowledge (I-MAK) together filed a patent opposition before the Delhi Patent office to prevent Gilead from gaining a patent in India.
“To get a patent under the law, you need to show that your drug is scientifically new. We believe that Gilead does not meet this lawful requirement. Opposing the patent at the examination stage is a way of ensuring patients have access to this drug at affordable prices without unnecessary patent barriers standing in the way,” said Tahir Amin, Director of intellectual property at I-MAK.
In the last decade, availability of affordable generics drugs dramatically expanded access to HIV treatment to millions across the world. As HIV becomes an increasingly manageable chronic infection in developing countries, more people are now dying of complications from the co-infection with hepatitis C virus, undermining the success of the HIV treatment scale-up.
“The Indian government is providing TB and HIV treatment to millions of patients. It has the same responsibility to treat HCV and save millions of people who are chronically infected with HCV in India. We learnt with HIV that we have to fight for a national treatment programme to start with and for drugs to be affordable, and we are now applying these lessons to hepatitis C,” said Loon Gangte, of International Treatmemt Preparedness Coalition (ITPC), South Asia.