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.
All components of this story
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...
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.
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.
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....
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.”...
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....
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.
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...
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...
- Related stories: Médecins Sans Frontières raises concerns over Gilead Sciences' anti-diversion programme for Hepatitis C drug
- This is a response from the following companies: Gilead Sciences
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...