[Ip-health] INDIAN HEALTH MINISTRY URGED TO BEGIN PROVIDING HEP-C TREATMENT NOW : OPPOSE PATENT ON NEW HEPATITIS C DRUG AND DEMAND AFFORDABLE ACCESS

Tahir Amin tahir at i-mak.org
Thu Mar 20 15:45:59 PDT 2014


*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 (HCV) 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 deterrent 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's 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," said Vikas Ahuja, President of
DNP+.



Although Gilead Sciences, 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, a US pharmaceutical company 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 applying these lessons to hepatitis C,"
says Loon Gangte, of ITPC South Asia.



*Contact:* Shailly Gupta: +91 9899976108

shailly.gupta at geneva.msf.org


-- 
Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+1 646 884 7418/+44 771 853 9472
*Press: *The Guardian http://tinyurl.com/mooycg5 |The New York Times:
http://tinyurl.com/kowtmzn



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