Ahead of a meeting at Jaipur in India next week between US pharmaceutical company Gilead Sciences and several Indian pharma companies, the international medical humanitarian organisation Medecins Sans Frontieres (MSF) has urged the Indian generic companies to reject Gilead’s controversial hepatitis C ‘Anti-Diversion’ programme as it could compromise patient treatment and privacy rights.
Calling upon the Indian companies, which have entered into an agreement with Gilead to produce hepatitis C drugs, to reject this highly controversial programme, the MSF said the programme—which places multiple restrictions and demands on people receiving treatment—is designed solely to protect Gilead’s commercial interests, and is unprecedented.
“We’ve never seen anything like Gilead’s anti-diversion programme before, where a company can potentially violate patient confidentiality and compromise treatment outcomes in order to protect its profits. Gilead is forcing medical providers to introduce policing measures that could lead to dangerous treatment interruption for patients”, said Dr Manica Balasegaram, executive director of MSF’s Access Campaign. “We are urging all Indian companies that have signed a licence with Gilead to refuse to implement this controversial anti-diversion programme, so more people in desperate need of this treatment can access it without having to first submit to an unacceptable set of rules and invasion of their privacy.”
The programme may require all patients receiving treatment to present national identification and residency papers, which could immediately disqualify migrants, refugees or marginalized people who may not have such papers, but are often those most affected by hepatitis C. It also requires people receiving treatment to submit to a highly-controlled dispensing procedure that could undermine patient confidentiality, and does not allow people to continue treatment if they do not return their previous empty pill bottle. This could result in treatment interruptions and even treatment failure, the MSF said.
“We’re seeing Gilead trying everything it can to squeeze every last drop of profit out of some middle-income and high-burden countries, and millions of people with hepatitis C will have to pay the price”, said Rohit Malpani, director of policy and analysis at MSF’s Access Campaign. “We are urging Gilead to make urgent changes to its company policies and its licensing agreements so that millions of people with hepatitis C are not left behind.”
MSF is working to start treating people with hepatitis C in nine developing countries, and is looking for affordable all-oral hepatitis C medicines (direct-acting antivirals) to simplify treatment scale-up for both doctors and patients. Through discussions with Gilead and generic companies over accessing the drug sofosbuvir, MSF has learned about the anti-diversion programme Gilead wants in place to prevent people in developed and some middle-income countries—where the drug is exorbitantly priced—from accessing low-cost versions not available in their own countries. In the US, Gilead charges $1,000 per pill for sofosbuvir, or $84,000 for a three-month treatment course, the MSF said.