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

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Tue Jan 27 02:38:23 PST 2015

*Médecins Sans Frontières / Doctors Without Borders (MSF) response to
announcement by Gilead Sciences regarding expansion of voluntary license to
include hepatitis C drug GS-5816*


*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 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 countries 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

  *- 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
T: @joanna_keenan


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