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[e-drug] MSF urges Indian generic companies to reject Gilead's Hep C programme

E-DRUG: MSF urges Indian generic companies to reject Gilead's Hep C programme

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 

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: 
For MSF's analysis of Gilead's hepatitis C voluntary licence see: 
MSF's take on Gilead's 'treatment expansion' fact sheet: 
Gilead's HCV Treatment Expansion fact sheet: 
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

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