Gilead Sciences's decision to expand its existing voluntary licence agreement with eight Indian generic companies for sofosbuvir and ledipasvir to include its investigational compound GS-5816 has come in for severe criticism from the international humanitarian organisation Médecins Sans Frontières (MSF) as that will restrict access to the drugs for people across the developing world.

“We welcome the interest of generic companies to scale up production of direct-acting antivirals for hepatitis C, but a highly-restrictive voluntary licence which restricts access to the drugs for people across the developing world is not acceptable. MSF hopes that governments will take all relevant measures under global trade rules to ensure access to these medicines at low cost and without any measures or requirements imposed by Gilead,” said Rohit Malpani, Director of Policy & Analysis, MSF Access Campaign.

These drugs are direct-acting antivirals used in the treatment of the hepatitis C virus (HCV).  GS-5816 is an important anti-hepatitis C compound that, in combination with sofosbuvir, will greatly simplify treatment for developing countries.  The compound is pan-genotypic (covers all different genotypes of HCV) which will simplify treatment, reduce the cost of diagnosis and help harmonise treatment regimens.  The drug may also help to shorten treatment from 12 weeks to 8 weeks for some genotypes.

Access to low-cost versions of hepatitis C compounds, including GS-5816, is critical to expanding access to treatment in developing countries. Gilead’s voluntary licence falls short of ensuring widespread access to these new drugs in middle-income countries, where over 70 percent of people with hepatitis C live today, the MSF said.“Not only does Gilead’s licence agreement exclude millions of people with hepatitis C, it also imposes ethically and medically questionable restrictions on patients and medical providers as part of an anti-diversion programme that the company is seeking to roll out in all low- and middle-income countries for the sole reason of protecting its commercial interests.  Gilead’s anti-diversion programme not only potentially jeopardises patient confidentiality and privacy, but could also exclude many patients that may lack the citizenship and identification papers that Gilead requires them to have in order to get access to treatment. Gilead’s programme introduces coercion and policing upon medical providers and may result in treatment interruptions for patients, leading to treatment resistance and failure.  As far as is known to MSF, such a programme, motivated solely by commercial interests, is unprecedented”, Malpani further says.