Strategies to Secure Access to Generic Hepatitis C Medicines

MSF is in the process of starting to treat people who are living with hepatitis C virus (HCV) in at least nine countries, and therefore is in need of affordable access to direct acting antiviral (DAA) treatments, including those marketed by Gilead Sciences (Gilead) and Bristol-Myers Squibb (BMS).

Gilead has signed voluntary licenses with 11 Indian generics manufacturers to market generic versions of Gilead’s DAAs in some low- and middle-income countries, while BMS will soon sign voluntary licenses with a few generics manufacturers. However, Gilead’s voluntary licenses restrict access to affordable generic versions of these DAAs for millions of people with HCV in 50 middle-income countries (MICs). It is expected that BMS’s license will have similar restrictions.  

There are legal means that countries excluded from voluntary licenses can consider using to get access to affordable generic versions of DAAs. Countries must also overcome regulatory barriers that may keep both branded and generic versions of DAAs from entering the market.

This document offers guidance to policy makers to enable access to these medicines to scale up HCV treatment.