[Ip-health] Statement of CSOs in Thailand: Gilead's VL on SOF

Jockey jockey.kit at gmail.com
Mon Sep 15 22:25:26 PDT 2014


*Statement of Civil Society Organizations in Thailand*



*Voluntary License on Sofosbuvir  and Ledipasvir between Gilead Sciences
Limited and Generic-medicine Manufacturers in India*





September 16, 2014



Civil society organizations working on access to HIV and HCV treatment in
Thailand, as listed at the end of the statement, are appalled by the
announcement of the voluntary license agreed between Gilead Sciences
Limited and a number of generic-medicine manufacturers in India. We were
hoping that Gilead's new drug, sofobruvir, would be both a life-line to the
almost one and half million people infected with the hepatitis C virus
(HCV) in Thailand and a potential means of eradicating this disease
worldwide. Instead we are now faced with corporate greed building yet
another barrier to  access to a new medicine needed by millions of people
with HCV infection in middle-income countries, instead of a mechanism
promoting access to this life saving treatment for ALL who need it.



Gilead announced its great contribution to the promotion of access to HCV
treatment by signing an agreement on licensing a new HCV-medicine, known as
sofosbuvir, to Indian generic-drug manufacturers yesterday.  In fact, the
agreement is a disastrous threat to the lives of people with HCV infection,
particularly those in middle-income countries where 73% of people with HCV
live.  Due to  restrictive conditions set down by Gilead, the Indian
licensees are only allowed to supply affordable generic version of
sofosbuvir to 91 low and middle income countries. In those  middle-income
countries not included in the deal, millions of people will be effectively
handed a  death sentence as Gilead's new lifesaving medicine will be
unaffordable.



On the one hand, Gilead is filing patent applications on sofosbuvir in
India. But the ground for these patents are questionable under Indian
patent law and India civil society organizations have filed patent
oppositions with the Intellectual Property Office of India and the patents
have not yet been granted. In Egypt, the sofosbuvir patent was rejected.



On the other hand, Gilead is attempting to maintain their market monopoly
by undermining generic competition and locking Indian low cost generic
manufacturers into voluntary licenses that exclude many middle income
countries such as Thailand, Brazil, Ukraine, Russia, Turkey, Romania,
Mexico, Philippines, and China, where people with HCV infection is higher
than 1 million.  More than 49 million people in the excluded MICs with high
HCV prevelence are not able to access affordable sofosbuvir. This tactic
has been used in the past with voluntary licenses on HIV/AIDS medicines
such as tenofovir.



Pegylated interferon (PEG-INF) and ribavirin (RBV) is the treatment for HCV
infection that is currently widely used in developing countries.  However,
this treatment has a poor cure rate and many patients experience very
unpleasant side effects.



Gilead's sofobuvir is a new HCV treatment that gives better cure rates with
less side effects but it is priced beyond the reach of most people. In the
USA, the cost is US$ 84,000 per treatment or US$ 1,000 per pill. The  generic
version, to be made available under Gilead's licensing agreement, will cost
in the region of US$900 per treatment or US$10 per pill for those 91 low
and middle income countries included in the agreement.  But what about
those countries excluded from this licensing agreement?  And, experts have
shown that sofosbuvir can be produced generically for mass scale-up,
including a profit margin, for $101 for a 12-week course.



In Thailand, people with HCV infection are entitled to PEG-INF/RBV
medication at no cost under the Universal Coverage Scheme.  But, with such
barriers (both patent protection and voluntary licenses), it is difficult
for the Thai government to provide sofosbuvir for its own citizens with HCV
infection. According to the global Hepatitis C prevalence data of 2010, it
is estimated that approximate 1.45 million Thais having HCV infection (2.2%
of the total population).  Due to a lack of access to generic sofosbuvir to
be sold by Indian manufacturers under the voluntary license, if the Thai
government wants support a national HCV treatment programme with
sofosbuvir, it will cost at least US$ 121 billion, which is equivalent to
49% of Thailand’s annual health budget, insteaf of US$ 1.3 billion (generic
version’s price under the license).



Generic medicines’ competition is the most effective mechanism to ensure
significant reduction in drug prices. The Gilead voluntary licenses agreed
with the Indian generic-medicine industry are restrictions that will
jeopardize competition by selectively limiting countries who can purchase
the medicines from India. Therefore, prices will remain high and large
numbers of people with HCV infection globally will be denied access to this
treatment.



Gilead must stop undermining the generic-medicine industry’s competition
and repeal the conditions in voluntary licenses that exclude millions of
people in order to fulfill their stated commitment to addressing the unmet
medical needs of patients living with life-threatening diseases around the
world.







AIDS ACCESS Foundation

Drug Study Group

Foundation for AIDS Rights (FAR)

Foundation for Consumers (FFC)

FTA Watch

People’s Health System Movement

Thai AIDS Treatment Action Group (TTAG)

Thai Network of People living with HIV/AIDS (TNP+)

Thai NGO Coalition on AIDS (TNCA)

Thai Holistic Health Foundation

The Rural Pharmacist Association

The Rural Pharmacist Foundation
12 D Thai Coalition on Harm Reduction



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