15 Apr, 14 | by BMJ
Picture the scenario: a disease is destroying your liver and there’s a chance you will die. There’s a cure, but you can’t have it as it costs more than you earn. There are tens of millions more of people like you. Hundreds of thousands of them die every year.
It sounds like some sci-fi dystopia, but this is the situation that the 150 million people who have hepatitis C virus (HCV) find themselves in today. HCV is spread through blood-to-blood contact, mostly through shared needles. Around 350,000 people die of HCV related liver complaints each year, but new drugs have been developed within the last six months with cure rates higher than 90 per cent.
Big pharmaceutical companies such as Gilead are pricing it up to $84,000 (£50,000)—that’s $1000 (£600) a pill.
“Not only is eradicating HCV within our grasp, it’s something that could be achieved well within in our lifetime,” says Leigh Daynes, executive director of Doctors of the World (Médecins du Monde) UK which is campaigning to increase global access to the new HCV drugs. “Pharmaceutical companies need to work with us to get these essential, life-saving drugs to those that need them. Thousands are dying each week they delay.”
Gilead was granted regulatory approval in 2013 for the leading HCV drug Sofosbuvir—brand name Sovaldi—and plans to sell the drug for a reduced rate of around $2,000 (£1200) in middle income countries where around three quarters of the world’s HCV infected people live. But even then most will still be unable to access the drug.
Egypt—which has the world’s highest prevalence of HCV—is one such middle income country that Gilead announced would be getting discounted treatments.
“Gilead are only giving a discount to a restricted number of people who access public health centres in Egypt,” said Chloé Forette, harm reduction and hepatitis C advocacy officer at the launch of Doctors of the World’s report on access to HCV medicines. “For those forced to buy it privately it is likely to be five times more expensive.”
To put this in context the monthly average salary in Egypt is $250 (£150).
Gilead may grant what’s known as a “voluntary licence” for some low income countries, meaning generic producers are given permission to make the drug and distribute it in these countries at a lower price. Most who need the drug globally, however, would remain excluded.
“This licence is likely to be restricted to 60 countries, which would be the smallest ever scope for a voluntary licence, excluding around 60 per cent of the people infected worldwide,” says Chloe Forette. “And even in these countries many still won’t be able to afford it as there’s no international funding mechanism available to buy these drugs for people.”
Industry analysts believe the demand for these treatments will translate into annual sales of $9.1 billion (£5.4 billion) for Sovaldi alone by 2017. Those in the pharmaceutical industry often argue that high prices are necessary to pay for the drug’s research and development (R&D) costs. This is not the case for Sovaldi, which is an adaptation of an existing molecule. And even where R&D costs are high, these can be recouped—while also allowing for a healthy profit—from sales in rich countries alone.
Suggested ways to make the treatment affordable through generic competition, include patent opposition—where the 25 year long monopolies on drugs are challenged—and compulsory licensing—where pharmaceutical companies are forced to allow others to manufacture the drugs so they can be made and sold for a reasonable price. The World Health Organisation has called for a “multi-pronged” approach to tackle the issue which could include tiered price discounts, voluntary licensing, and compulsory licensing.
“There needs to be a global renegotiation about access to commodities when it comes to global public health threats,” says Michel Kazatchkine, UN General Secretary Special envoy for HIV and AIDS in Eastern Europe and Central Asia. “We have to consider all of the current means we have to bypass the very basic and fundamental contradiction between our international, intellectual property treaties, and our treaties on human rights and access to health.”
Many of these battles regarding access to medicines have already been fought, with some success, by those calling for cheaper HIV and AIDS drugs since the 1990s, which is giving HCV activists hope. In 2000 antiretroviral HIV drugs cost $15,000 (£9000)—meaning only five per cent of people in low and middle income countries could get them. Thanks to generic competition, 15 years later the same therapy can cost around $60 (£36) and more than half of people in these countries can access them.
Activists hope it will not be such a long struggle with HCV, especially as, unlike HIV, these treatments have the potential to cure the disease in a single short course.
“We have an opportunity to eradicate the virus and so this is a chance to bring the debate back to the international level about our inability to deal with all the major public health issues such as HIV, TB, malaria, and hepatitis C,” says Kazatchkine. “People will continue to die in large numbers unless we completely rethink this fundamental contradiction between human rights and intellectual property.”
Read Doctors of the World‘s report on global access to HCV treatments.
Competing interests: I have read and understood BMJ policy on declaration of interests and declare that I have no competing interests.
Nick Harvey is the communications manager at Doctors of the World UK, part of the Médecins du Monde network.