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[e-drug] MSF response to Gilead on inclusion of hepatitis C drug GS-5816 in voluntary licence

E-DRUG: MSF response to Gilead on inclusion of hepatitis C drug GS-5816 in 
voluntary licence


New Delhi/Geneva - 26 January 2015 - Gilead Sciences today announced it 
was expanding its existing voluntary licence agreement with eight Indian 
generic companies for sofosbuvir and ledipasvir to include its 
investigational compound GS-5816. These drugs are direct-acting antivirals 
used in the treatment of the hepatitis C virus (HCV). 

GS-5816 is an important anti-hepatitis C compound that, in combination 
with sofosbuvir, will greatly simplify treatment for developing countries. 
 The compound is pan-genotypic (covers all different genotypes of HCV) 
which will simplify treatment, reduce the cost of diagnosis and help 
harmonise treatment regimens. The drug may also help to shorten treatment 
from 12 weeks to 8 weeks for some genotypes.

However, it appears that none of the terms and conditions of the original 
licence agreement has been changed, meaning that the concerns that MSF has 
with the licence agreement remain, including the limited geographic scope 
of the agreement, restrictions on the production and export of active 
pharmaceutical ingredient, and the inclusion of an ethically and medically 
controversial and problematic anti-diversion clause. 
For more on Gilead?s  anti-diversion clause, see our briefing document: 
Médecins Sans Frontières (MSF) responds to the announcement with the quote 
below :

'Access to low-cost versions of hepatitis C compounds, including GS-5816, 
is critical to expanding access to treatment in developing countries. 
Gilead's voluntary licence falls short of ensuring widespread access to 
these new drugs in middle-income countries, where over 70 percent of 
people with hepatitis C live today.

'Not only does Gilead's licence agreement exclude millions of people with 
hepatitis C, it also imposes ethically and medically questionable 
restrictions on patients and medical providers as part of an 
anti-diversion programme that the company is seeking to roll out in all 
low- and middle-income co'ntries for the sole reason of protecting its 
commercial interests.  Gilead?s anti-diversion programme not only 
potentially jeopardises patient confidentiality and privacy, but could 
also exclude many patients that may lack the citizenship and 
identification papers that Gilead requires them to have in order to get 
access to treatment. Gilead's programme introduces coercion and policing 
upon medical providers and may result in treatment interruptions for 
patients, leading to treatment resistance and failure.  As far as is known 
to MSF, such a programme, motivated solely by commercial interests, is 

'We welcome the interest of generic companies to scale up production of 
direct-acting antivirals for hepatitis C, but a highly-restrictive 
voluntary licence which restricts access to the drugs for people across 
the developing world is not acceptable. MSF hopes that governments will 
take all relevant measures under global trade rules to ensure access to 
these medicines at low cost and without any measures or requirements 
imposed by Gilead.'

Rohit Malpani, Director of Policy & Analysis, MSF Access Campaign

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign 
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org

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