E-DRUG: MSF response to Gilead on inclusion of hepatitis C drug GS-5816 in voluntary licence
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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:
http://www.msfaccess.org/content/barriers-access-and-scale-hepatitis-c-hcv-treatment-gileads-anti-diversion-program
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
unprecedented.
'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