E-DRUG: MSF urges Indian generic companies to reject Gilead's Hep C programme
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MSF urges Indian generic companies to reject Gilead's controversial hepatitis C 'Anti-Diversion' programme
Hi all
MSF has this morning issued a press release and a series of documents -
all linked below - highlighting Gilead's anti-diversion programme with
sofosbuvir, ahead of their meeting next week with generic manufacturers in
India.
Indian generic companies should reject Gilead's controversial hepatitis C 'Anti-Diversion' programme
Programme could compromise patient treatment and privacy rights
MSF releases briefing note on Gilead's anti-diversion programme and
analysis of company's license agreement
New Delhi/ Geneva, 18 March 2015
Ahead of a meeting in Jaipur, India next week between US pharmaceutical company Gilead Sciences and several Indian
companies which have entered into an agreement with Gilead to produce hepatitis C drugs, Médecins Sans Frontières/Doctors Without Borders (MSF) urged the generic companies to reject a highly-controversial programme that could compromise people?s treatment and confidentiality.
The programme which places multiple restrictions and demands on people
receiving treatment is designed solely to protect Gilead's commercial interests, and is unprecedented as far as MSF is aware.
To see MSF's briefing note on Gilead's anti-diversion programme go to:
http://www.msfaccess.org/content/barriers-access-and-scale-hepatitis-c-hcv-treatment-gileads-anti-diversion-program
For MSF's analysis of Gilead's hepatitis C voluntary licence see:
http://www.msfaccess.org/content/barriers-access-and-scale-hepatitis-c-hcv-treatment-gileads-voluntary-license-agreement
MSF's take on Gilead's 'treatment expansion' fact sheet:
http://www.msfaccess.org/content/fact-sheet-gileads-chronic-hepatitis-c-treatment-restrictions
Gilead's HCV Treatment Expansion fact sheet:
http://www.gilead.com/~/media/Files/pdfs/other/HCVGenericAgreementFactSheet.pdf
MSF is working to start treating people with hepatitis C in nine
developing countries, and is looking for affordable all-oral hepatitis C
medicines (direct-acting antivirals) to simplify treatment scale-up for
both doctors and patients. Through discussions with Gilead and generic
companies over accessing the drug sofosbuvir, MSF has learned about the
anti-diversion programme Gilead wants in place to prevent people in
developed and some middle-income countries - where the drug is exorbitantly
priced - from accessing low-cost versions not available in their own
countries. In the US, Gilead charges $1,000 per pill for sofosbuvir, or
$84,000 for a three-month treatment course.
'We've never seen anything like Gilead's anti-diversion programme before,
where a company can potentially violate patient confidentiality and
compromise treatment outcomes in order to protect its profits. Gilead is
forcing medical providers to introduce policing measures that could lead
to dangerous treatment interruption for patients', said Dr. Manica
Balasegaram, Executive Director of MSF's Access Campaign. 'We are urging
all Indian companies that have signed a licence with Gilead to refuse to
implement this controversial anti-diversion programme, so more people in
desperate need of this treatment can access it without having to first
submit to an unacceptable set of rules and invasion of their privacy.'
The programme may require all patients receiving treatment to present
national identification and residency papers, which could immediately
disqualify migrants, refugees or marginalized people who may not have such
papers, but are often those most affected by hepatitis C. It also requires
people receiving treatment to submit to a highly-controlled dispensing
procedure that could undermine patient confidentiality, and does not allow
people to continue treatment if they do not return their previous empty
pill bottle. This could result in treatment interruptions and even
treatment failure.
While Gilead has exempted MSF from this programme in Pakistan only, MSF is
greatly concerned that this programme will establish an ugly precedent and
will be introduced in all countries where the company and its generic
licensees sell the drug. There are an estimated 150 million people living
with the disease worldwide, the vast majority in developing countries.
'Now is the time to make sure as many people as possible can be treated
and cured of hepatitis C, not to look for ways to restrict people's access
to treatment and overburden drug dispensers with rules that are
unnecessary', said Rohit Malpani, Director of Policy and Analysis at MSF's
Access Campaign. 'Gilead's actions are unacceptable.'
MSF today also released a technical analysis of Gilead's voluntary licence
agreement with Indian manufacturers, which excludes 50 middle-income
countries, where 49 million people with hepatitis C live, including
Thailand, Brazil, China and Morocco. The licence imposes multiple
restrictions on where the drug can be sold and where active pharmaceutical
ingredients can be sourced, but perhaps the most concerning is its
excessively broad definition of a patent and product patents. This
definition allows Gilead to deny patients in excluded countries access to
low-cost generic versions of the drug produced under the licence, even if
the patent in the excluded country has been rejected and is under appeal,
or is pending. Meanwhile, Gilead does not currently have a granted
product patent in India for any direct-acting antiviral.
Gilead is putting in place a 'tiered pricing' strategy for the
middle-income countries excluded from its licence, which will likely
result in high prices for these developing countries that could range from
$2,000 to $15,000 or more per three-month treatment course. Research from
Liverpool University shows that sofosbuvir could be produced for roughly
$1 per pill, or $101 per treatment course.
'We're seeing Gilead trying everything it can to squeeze every last drop
of profit out of some middle-income and high-burden countries, and
millions of people with hepatitis C will have to pay the price', said
Malpani. 'We are urging Gilead to make urgent changes to its company
policies and its licensing agreements so that millions of people with
hepatitis C are not left behind.'
- ends -
Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
E: joanna.keenan[at]geneva.msf.org