The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) began introducing hepatitis C (HCV) treatment to several patients in India in 2013, and is in the process of scaling up treatment for HCV in several additional countries. MSF plans to use direct acting anti-viral medicines that have recently come to market that have the potential to revolutionize treatment for people living with HCV. One critical drug that MSF will procure for use in its treatment programmes is sofosbuvir, which was launched by Gilead Sciences in 2013, and is marketed as Sovaldi.
As Gilead is the sole producer of sofosbuvir (no generic versions have been launched in any country), governments, MSF and other treatment providers are dependent on the willingness of the company to make this urgently-needed drug available and accessible.
In the course of discussions with Gilead to purchase the drug, MSF has learned that the company will institute an ‘anti-diversion’ programme in developing countries through its distributors and licensees (generics companies that have signed a voluntary license with Gilead) to prevent what they characterize as the possible ‘bulk diversion’ or re-sale of such medicines from low- or middle-income countries to high-income countries.
With this programme, Gilead is demanding that patients and treatment providers in developing countries comply with a web of onerous and potentially harmful procedures that aim to preserve Gilead’s ability to charge exorbitant prices in developed countries (up to US$1,000 per pill, or $84,000 per treatment course).
Gilead’s programme violates patient privacy and autonomy, undermines confidentiality of patient data, 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.
Registration of the drug is already being fast-tracked in a number of high-burden countries—for example registration is complete in Egypt, nearing completion in Pakistan, and India is considering it—so Gilead’s programme could impact patients in a number of countries in very short order.