[Ip-health] MSF response to Gilead’s deal with generic companies for sofosbuvir and ledipasvir

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Wed Sep 17 05:37:39 PDT 2014

Hmm, sorry folks - thought I had posted MSF's response to the Gilead
licences, but I guess not. Please find below.
MSF response to Gilead’s deal with generic companies for sofosbuvir and

*15 September 2014* - Gilead Sciences has announced agreements with a
handful of Indian pharmaceutical manufacturers to produce and sell generic
versions of two new hepatitis C drugs – sofosbuvir and ledipasvir.
Approximately 180 million people live with hepatitis C today, with 350,000
people dying annually of the disease.

 New oral drugs like sofosbuvir and ledipasvir, known as direct-acting
antivirals (DAAs), hold significant promise to improve treatment outcomes
for hepatitis C patients around the world, with studies showing high cure
rates.  US and EU regulators have approved two new DAAs within the last 10
months, and others are in development. However, the high prices set by
Gilead for sofosbuvir, for example, are an important barrier to scaling up
access to diagnostics and treatment.

 Increasing generic competition is an important strategy in reducing prices
and increasing sustainable affordable access when companies file for patent
protection for essential medicines. Although the Gilead agreements will
allow some generic companies to market generic versions of both drugs in
approximately 90 countries regardless of the patent status in those
countries, most of the countries expected to be included in the license
agreements are low-income economies, many of which may not have had patent
protection on these new drugs in the first place.  Hepatitis C is
especially prevalent in middle-income countries – with approximately 73% of
the burden in these countries – but disappointingly many of these countries
remain excluded from accessing both Gilead’s lowest price and the generic
versions licensed by these agreements.

 It remains to be seen whether in reality the terms and conditions offered
by Gilead will enable widespread access to an optimised and affordable
regimen needed for millions of people in low and middle income countries,
including patients seeking treatment from MSF.  MSF is preparing to
initiate treatment in a few medical projects using new direct acting
antivirals for people living with chronic HCV.

*MSF response to Gilead’s announcement:*

“Gilead’s licensing terms fall far short of ensuring widespread affordable
access to these new drugs in middle-income countries, where over 70 percent
of people with hepatitis C live today.

Gilead’s deal excludes many middle-income countries considered by industry
to be profitable emerging markets, even though people living with chronic
hepatitis C in these countries often come from poor and marginalised
communities with little ability to pay for expensive medicines.

We welcome the interest of generic companies to scale up production of new
direct-acting antivirals and Gilead’s decision to make the final agreement
public; however, a highly restrictive voluntary license that blocks
millions of people with Hepatitis C from affordable prices is not
acceptable. MSF hopes that excluded governments will take all relevant
measures available under global trade rules and national patent laws to
secure low-cost generic versions of these medicines.”

---- Rohit Malpani, Director of Policy and Analysis, Médecins Sans
Frontières, Access Campaign
 *Background notes for editors:*
 Earlier this year, Gilead Sciences approached multiple generics
manufacturers in India to sign licensing agreements for sofosbuvir and
ledipasvir.   Some key limitations of what is so far known about Gilead’s
terms and conditions are highlighted here.

 Gilead and the Indian generic companies are signing the agreements before
the Indian patent office has had the opportunity to determine whether the
patent claims on these two new drugs deserved to be granted or rejected.
Multiple patent oppositions have been filed on Gilead’s key patents in
India by treatment groups and generics firms. Egypt has rejected key
patents on sofosbuvir and a local firm in Egypt has already registered and
will sell sofosbuvir in the Egyptian market without any license with

 The licenses are expected to set precise terms by which companies can make
generic equivalents and where and under what circumstances those generics
and the raw material (active pharmaceutical ingredients, or API) can be
manufactured and sold. For example, because Ukraine is a middle-income
country excluded from the deal, MSF will not be able to use affordable
Indian generics for its medical project in Ukraine when MSF initiates
treatment for hepatitis C as a part of the recently-awarded UNITAID grant.

 Sofosbuvir is likely to be the key drug in combinations that are included
in WHO’s treatment guidelines. However, another drug that can be paired
with sofobuvir to offer a pan-genotypic treatment regimen, GS5816, has not
been included in the license deals, even though phase 2 results have been
very promising.

 In territories excluded from these deals, Gilead is prohibiting generic
competition from those generics companies that are signing a license
agreement with Gilead, and will be able to charge high prices for these
life-saving medicines based on a monopoly position.  Voluntary license
agreements often provide generics firms with access only to those markets
which a multinational company does not want to or cannot exploit through
monopolistic marketing, distribution and sales.  In this license agreement,
restrictions that prohibit generic companies from exporting the licensed
HCV products to middle-income countries potentially exclude millions of
patients living with HCV from access to treatment.

 Most of the countries expected to be included in the license agreements
will be low-income economies, but Hepatitis C is especially prevalent in
middle-income countries – with approximately 73% of the burden in these
countries.  In nearly all low and middle income countries, governments will
struggle to pay for new treatments, especially in the absence of donor
assistance, forcing patients to pay out of pocket.  The biggest crunch will
come in middle-income countries who are excluded from this deal and
Gilead’s LIC pricing.

 Recent and upcoming patent oppositions filed against sofosbuvir, including
in India, could have been used by generic companies to seek better terms
from Gilead, or to simply develop these products without a license
agreement and to supply countries for which no patents have been granted,
will not be granted or for which barriers can be overcome through the
exercise of public health safeguards available to companies, civil society
and all governments.

Robust generic competition is the key to bringing down prices and
increasing access to sofosbuvir, which Gilead has priced at $1,000 per pill
in high-income countries, or US$84,000 for 12 weeks’ treatment, and around
US$900 for the same in low-income countries.  Prices for middle-income
developing countries will be significantly higher than the $900 price,
particularly in the private market A study by researchers at Liverpool
University however has found that a twelve-week course of sofosbuvir could
cost as low as $101 and ledipasvir only $93, which can be achieved with
large scale generic production.

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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