Médecins Sans Frontières raises concerns over Gilead Sciences' anti-diversion programme for Hepatitis C drug

Médecins Sans Frontières released a briefing paper in January 2015 highlighting "serious ethical concerns" over Gilead Sciences' anti-diversion programme for a hepatitis C (HCV) drug.  These concerns relate to the right to health and privacy, and access to medicines.

Business & Human Rights Resource Centre invited Gilead Sciences to respond to the briefing.  The full briefing and the company's response are provided below.

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Article
12 April 2015

Activists & generics companies "pushback" on Gilead Sciences' anti-diversion policy

Author: Amy Kazmin, Financial Times

...Gilead denies requiring Indian generics companies, and their distributors, to collect and maintain records of all patients purchasing the drug in India, but says it has asked generic firms to take reasonable steps to deter large-scale “diversion” of the drug to other countries...Executives at Indian drugmakers say that Gilead had been pushing for strict surveillance over sofosbuvir use in India...Gilead has since softened its stance in India following “pushback” from activists and the generics companies themselves...

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Item
20 March 2015

Comment by Anand Grover

Author: Anand Grover, former United Nations Special Rapporteur on the right to health

Gilead’s anti-diversion measures contradict their stand on improving access to crucial HCV medicines, and is, arguably, a violation of the right to health... Gilead must re-evaluate their anti-diversion model if they want to be taken seriously as a company that promotes access to medicines for patients in need.

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Item
20 March 2015

Comment by Brook Baker

Author: Brook Baker, Professor of Law at Northeastern University, UNITAID civil society board member and Board member of Health Global Access Project

The human rights and patient consequences of Gilead's proposed anti-diversion policies in its tiered-pricing and licensing programs for sofosbuvir, listed by MSF, are quite specific and substance-focused... Gilead's response on the other hand is vague and process oriented - it promises consultation with no specifics in terms of the concerns raised.

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Article
20 March 2015

Comment by Karyn Kaplan

Author: Karyn Kaplan, Director, International Hepatitis/HIV Policy & Advocacy, Treatment Action Group

...Gilead is now forcing both doctors and patients in resource-limited settings to jump through unethical hoops before accessing low-cost versions of these drugs. A restrictive anti-diversion clause in their recent license to Indian generic producers forces clinicians to violate basic medical ethics and patient human rights by revealing confidential patient data....

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Article
20 March 2015

Gilead is Criticized for Restrictions on Generic Hepatitis C Drug Deal

Author: Ed Silverman, Wall Street Journal

...Doctors Without Borders notes that Gilead is attempting to enforce conditions on the 11 generic drug makers that would prevent the copies from being diverted to countries not covered by the agreement. But the relief organization argues Gilead is doing so in a way that may compromise patients in order to protect its commercial interests.... The relief group worries these moves create an “ugly precedent.”...

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NGO rejoinder
20 March 2015

Médecins Sans Frontières' rejoinder to Gilead Sciences

Author: Médecins Sans Frontières

MSF is highly disappointed that Gilead Sciences refuses to disclose the true nature, scope and intentions of its anti-diversion programme.  The company’s secrecy should set off alarm bells to all members of the hepatitis C community....

Download the full document here

Item
20 March 2015

Pharma accused of restricting access to hep C drug in poor countries

Author: Sarah Boseley, The Guardian

... Gilead has agreed to grant voluntary licences to eleven Indian generic companies, which means the drug will be sold at a reduced price in low-income countries. But Médecins Sans Frontières, the volunteer doctors who are treating hepatitis C infection in some of the poorest regions, say the company has imposed unacceptable conditions.

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Article
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Author: Chloé Hecketsweiler et Paul Benkimoun, Le Monde (France)

C'est un médicament miracle contre l'hépatite C, et vendu au prix fort. Au point que ses concepteurs redoutent un trafic et ont imaginé un plan de surveillance des malades totalement inédit...Médecins sans frontières (MSF) a donné l'alerte la semaine dernière : les dispositions prévues par le laboratoire américain Gilead, unique fabricant de la molécule sofosbuvir, pour éviter des reventes risquent de compromettre la santé des malades... 

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Company response
9 January 2015

Gilead Sciences' Response

Author: Gilead Sciences

...Gilead Sciences is working to help ensure access to its chronic hepatitis C medicines for all patients who can benefit from them. The company is... working with national governments to provide its branded medicines...As part of these efforts Gilead and its partners are designing measures to ensure that these high value curative medicines are not diverted...

Read full response here

Report
5 January 2015

Full briefing

Author: Médecins Sans Frontières

"Barriers to Access and Scale up of Hepatitis C (HCV) Treatment: Gilead’s Anti–Diversion Program, MSF Briefing Document, January 2015"

...MSF has learned that the company will institute an ‘anti-diversion’ programme in developing countries through its distributors and licensees…  to prevent what they characterize as the possible ‘bulk diversion’ or re-sale of such medicines…  Gilead’s programme violates patient privacy and autonomy...

Read the full briefing here