Doctors in France are challenging the patent of a new and highly expensive drug for hepatitis C in an attempt to bring down the price.
Sofosbuvir, costs $1,000 (£650) a pill for a 10-week course. The drug, made by the pharmaceutical multinational Gilead Sciences, is a cure for the viral infection that can lead to liver cirrhosis, cancer and death.
Even for affluent countries the bill is huge. In England, approximately 160,000 people are infected while globally, between 130 million and 150 million people are estimated to be infected, according to the World Health Organisation.
Recently, the National Institute for Health and Care Excellence (Nice) recommended that the drug should be available on the NHS, but granted NHS England a six-month delay. The bill is expected to reach £1bn for every 20,000 people treated.
Médecins du Monde (MdM) , a non-governmental organisation that provides healthcare for vulnerable people around the world, is challenging Gilead’s monopoly on the drug at the European Patent Office. If it wins, generic drug companies would be able to make cheap copies of sofosbuvir. There has already been a challenge in the Indian courts on other grounds, which Gilead lost, but the company is appealing. A challenge by a medical organisation in Europe is unprecedented.
“We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity,” said Dr Jean-François Corty, MdM’s French programmes director. “Even in a ‘rich’ country like France, with an annual medicines budget of €27bn [£20bn], it is difficult to meet this cost. We are seeing an arbitrary rationing approach that excludes patients from care, and this is unacceptable.”
The NGO is challenging the US company on two grounds. It argues that Gilead did not take “an inventive step” in developing the drug, because the real breakthrough was by researchers at Cardiff University at an earlier stage. It also says Gilead is claiming a more extensive patent than it originally filed in March 2007.
Olivier Maguet from Médecins du Monde said the challenge would send a strong message to developing countries, where there are many cases of hepatitis C and the drug is unaffordable. “Until now they have been on their own,” he said. The move “will give a lot of energy to countries in the south”.
