[Médecins du Monde press release, Link] Today, Doctors of the World – Médecins du Monde (MDM) has filed a European patent challenge against the Hepatitis C virus (HCV) drug, sofosbuvir. In recent months, Médecins du Monde and its partners have raised the alarm around the problems caused by the cost of new treatments against hepatitis C and of sofosbuvir [2] in particular. The U.S.-based pharmaceutical company Gilead holds a monopoly for sofosbuvir and is marketing a 12-week course treatment at extremely high prices – 41 000 euros in France and 44 000 euros in the United Kingdom – thereby hindering access to the drug for People Living with HCV.
A patent challenge is a legal procedure by which the validity of a patent is questioned. While using sofosbuvir to treat hepatitis C represents an important step forward, the molecule itself is not sufficiently innovative to warrant a patent. If successful, it can encourage competition from generic versions of sofosbuvir [3], which can drive price reductions closer to the cost of production. According to experts, this cost for sofosbuvir may be as low as $101 USD for a 12-week course.
Since Gilead is prioritizing its private rights over human rights, imposing unconscionable prices for healthcare systems, Doctors of the World – MDM has decided to challenge Gilead. This is the first time in Europe that a medical non-governmental organisation (NGO) uses this procedure to improve patient access to drugs. MDM believes that the price of sofosbuvir is unjust in part because public funds were used to research and develop the drug.
“We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity,” explains Dr Jean-François Corty, MdM’s French Programmes Director.“Even in a ‘rich’ country like France, with an annual medicines budget of 27 billion euros, it is difficult to meet this cost. We are seeing an arbitrary rationing approach that excludes patients from care, and this is unacceptable.”
According to the World Health Organisation (WHO), an estimated 130 to 150 million individuals are living with chronic hepatitis C. Within the European Union, it is estimated that between 7.3 and 8.8 million people are living with the virus. In France, 230, 000 people are reportedly chronic carriers of hepatitis C.
“Patent challenges have already been used by civil society in India, Brazil, the United States and around the world to remove weak or unmerited patents for drugs and to make low-cost generic versions available,” explains Olivier Maguet,MdM board member delegate for hepatitis C. “This has led to a substantial reduction in the cost of treatments, enabling access to drugs of patients who would otherwise be deprived of life-saving medicines.”
Doctors of the World – Médecins du Monde is taking up the fight to promote universal access to treatment against HCV in Europe and the rest of the world. MdM is also launching a public debate in France on thedrug pricing mechanismand its impact on the healthcare system.
For more information on this subject and on MdM’s positioning :
patentopposition.medecinsdumonde.org
Press contact:
Aurélie Defretin 01 44 92 13 81 // 06 09 17 35 59
infomdm@medecinsdumonde.net // www.medecinsdumonde.org
[1] Legal and technical advice: Initiative for Medicines, Access, & Knowledge (www.i-mak.org) and Lionel Vial, French and European patent attorney
[2] Sofosbuvir is a direct-acting antiviral (DAA) used in the treatment of hepatitis C.
[3] Hill A, van de Ven N, Simmons B, et al. Minimum target prices for production of treatment and associated diagnostics for Hepatitis C in developing countries (Abstract LBPE12). Poster presented at: 20th International AIDS Conference; 2014 July 20–25; Melbourne, Australia.
