One Company Stands Between Humanity and Access to the Hep C Cure - Doctors of the World

One Company Stands Between Humanity and Access to the Hep C Cure

By Chelsea Radler, Doctors of the World UK
*Editors Note: The original has been updated to reflect USD figures.

Read our PRESS RELEASE on MdM’s patent challenge to Hep C drug sofosbuvir (brand name Sovaldi).

For years, life with hepatitis C might be symptom free. Regular. Healthy. Then you feel tired, maybe feverish. But you don’t think twice. It’s probably the flu.

All the while, the virus could be wreaking havoc, working against your liver as it struggles to produce necessary proteins and rid the blood of toxins. Eventually, without the right treatment, the condition could kill you.

Up to half a million people from every corner of the globe die each year from cirrhosis, liver cancer and liver failure brought on by hepatitis C. And these deaths are – for the first time in history – largely preventable.

A breakthrough treatment, sofosbuvir (which goes by the brand name Sovaldi in the US), has cure rates as high as 96% when taken alongside other drugs; plus it works faster and with fewer side effects. But high prices set by a pharmaceutical company mean most people can’t afford the 12-week treatment, which costs anywhere from $84,000 to $168,000 in the US.

That’s more than the most families make in a year.

Although the FDA approved sofosbuvir for use in combination therapy in late 2013, there is no guarantee that your health insurance will cover the cost of the treatment. And, of the CDC’s estimated 4.4 million carriers of chronic hepatitis C in the US, a recent study conducted jointly by the University of Alabama and the University of Texas identified non-whites, those on Medicaid, and the uninsured as populations that are disproportionately affected by hepatitis C.

“The current price of the drug may be generating unbridled profit but it is putting the pill out of patients’ reach,” says Leigh Daynes, Executive Director of Doctors of the World UK. “And that costs lives.”

Gilead Sciences, Inc. – the patent holder – raked in upwards of $10 billion from sofosbuvir in 2014 alone and is fighting to keep competitors off the market. Generic sofosbuvir can be produced for as little as US $100-$136.

Today, Doctors of the World (Médecins du Monde) challenged Gilead’s monopoly on behalf of more than eight million chronic hepatitis C sufferers in the EU, becoming the first medical NGO to contest a drug patent with the European Patent Office.

This challenge is just the first step to ensuring access to fairly priced generic treatments for hepatitis C, but it could inspire other civil society organizations to take similar actions.

“This is an unprecedented step towards increasing access to a treatment that could save the lives of thousands of people living with Hep C in Europe,” says Daynes. “We cannot stand by as people suffer and die needlessly from a disease with a cure.”

The chemical process that makes new Hep C treatments so effective was discovered by public and private researchers. Campaigners argue that this invalidates the conglomerate’s exclusive claim to the drug.

“In patent law, you have to show that something is new and many of these patents are not new in scientific terms,” says Tahir Amin, director of the Initiative for Medicines, Access and Knowledge (I-MAK), which spearheaded a legal challenge in Indian courts last month. This denied a patent request for Gilead in India, opening cheaper generic markets there for sofosbuvir. “Once companies get patents, they control the marketplace,” Amin adds.

The patent challenges by Doctors of the World and I-MAK are part of a mounting international chorus calling for increased access to care for the 130-150 million hepatitis sufferers worldwide. Hepatitis C virus is spread through blood-to-blood contact, usually through shared needles or untested blood transfusions.

“Pharma’s high pricing of highly effective direct-acting antivirals is one of the great crimes of the century,” says Karyn Kaplan, policy and advocacy director at Treatment Action Group, a New York-based health think tank.

Last week, competition from other pharmaceutical companies forced Gilead to announce it would slash prices in the US.

We live in a world where life-saving medical care takes a back seat to corporate profits. But we don’t have to. Advocacy efforts and legal challenges provide a clear pathway to ensuring that where you live or how much money you have doesn’t determine what treatments are available.

“Hepatitis C has essentially been cured,” says Daynes. “Half a million deaths each year means half a million reasons to raise our voices to bring about the end of this epidemic.”

If you’re worried about hepatitis C, contact your healthcare provider and ask about a blood test.