Doctors Group Presses Indian Generics Makers to Reject Hep C Licensing Program

March 26, 2015

Médecins Sans Frontières is urging Indian generics makers to reject a program Gilead plans to implement in developing countries to prevent illegal diversion of its hepatitis C drugs to more lucrative markets.

Gilead says the program is necessary to prevent the possible bulk resale of the drugs sold at discount in low- or middle-income countries to high-income countries, where they can command prices of up to $84,000 for a course of treatment.

Under the program, MSF charges that patients would have to show distributors or  treatment providers  proof of identification, citizenship and residence to obtain licensed generic versions of Gilead’s Sovaldi (sofosbuvir) or Harvoni (ledipasvir/sofosbuvir). The brandmaker would have unrestricted access to the information in order to track the drug’s use, MSF notes.

The restrictions would also apply to a third Gilead drug, GS-5816, which is currently in clinical trials to treat all six genotypes of hepatitis C with a single tablet.

However, Gilead says the MSF is wrongly assuming that a unique label coding system, which has been implemented in Egypt to track the dispensing and return of each bottle of medication, will be replicated elsewhere, according to company spokesman Nick Francis. The coding system requires patients to provide proof of citizenship in Egypt, but is not intended to be universally applied to all low-and middle-income countries.

MSF released a briefing note criticizing the plan Thursday, hoping to influence a meeting this week in Jaipur between Gilead and 11 Indian companies: Aurobindo, Biocon, Natco, Cadila Healthcare, Ranbaxy, Sequent Scientific, Strides Arcolab, Cipla, Hetero Labs, Laurus Labs and Mylan.

Read MSF’s briefing note and analysis at www.fdanews.com/03-15-MSF-Note.pdf and  www.fdanews.com/03-15-MSF-Analysis.pdf, respectively. — Jonathon Shacat