Gilead to require proof of citizenship to buy Sovaldi in poor countries

Not long after Gilead Sciences' ($GILD) high-priced hep C superdrugs Sovaldi, and then combo drug Harvoni, hit the market, the California drugmaker struck deals with 11 generic drugmakers to make cut-rate versions available, and affordable, in 91 developing countries. But Gilead is not as generous as it might seem, Doctors Without Borders claims. It says Gilead has loaded up production agreements with nefarious requirements to milk it for profits, provisions that will make it hard, if not impossible, for some infected people to get the drug that could cure them.

Rohit Malpani

Médecins Sans Frontières/Doctors Without Borders (MSF) is urging Gilead ($GILD) to drop some of the provisions. If Gilead won't, MSF suggests that generic drugmakers ignore some of the requirements, like demanding that patients provide proof of citizenship to fill a prescription.

"We're seeing Gilead trying everything it can to squeeze every last drop of profit out of some middle-income and high-burden countries, and millions of people with hepatitis C will have to pay the price," said Rohit Malpani, of MSF.

A spokesperson for Gilead could not be reached today. The drugmaker has been lambasted in the U.S. for putting a retail price of $85,000 on Sovaldi and of about $94,000 on Harvoni, prices that have allowed Gilead to make back tens of billions of dollars on the medications in the first year on the market. They are a bit cheaper in Europe where regulators demanded it and Gilead is using tiered pricing in other countries depending on their economic profile. Fifty middle income countries will pay less than high-income countries but more than the 91 low-income countries, for example.

But MSF says to rake in the most it absolutely can, Gilead's licenses with the generic drugmakers make them demand that health providers put very tight controls on their sales. They must require patients to prove citizenship and residency to get their prescription filled. That, MSF says, is to prevent anyone from countries where the hep C drugs will be priced higher--countries like China, Thailand and Argentina--from buying cheaper versions of the drug in a low-cost country. Besides the fact that demanding papers may violate patient confidentiality, it could exclude anyone like immigrants with hep C from getting treatment, or even just poor people who don't have papers, the organization claims.

When IDs are provided, they will be used to put an identifying barcode on the bottles they receive with their name and other info. Not only can the code be used to guarantee only residents of the country get the drugs, Gilead is using the barcode track its sales and use and the agreements allow Gilead to use that patient information any way it chooses. While the barcode can be read with a smartphone, the group does not address the potential issues around how developing countries, where meds may be dispensed in remote areas, will be able to administer all of the provisions. 

The provisions require that patients then return a bottle to get a new bottle and allows them to get only one bottle of their prescription at a time, even though allowing them to get multiple bottles could "ease the burden on patients and health providers," MSF says.

The licenses are for 5 years and those who sign can't get out of them, even if a country they produce it for allows unrestricted sales of generics. In fact, India has rejected Gilead's patent but as MSF reads the agreement, the Indian drugmakers that have signed up would be prevented from selling cheaper versions there without the restrictions. MSF thinks Gilead is trying to lock all of these restrictions in now, ahead of any losing a patent fight in any country, to maximize its profits.

"We've never seen anything like Gilead's anti-diversion programme before, where a company can potentially violate patient confidentiality and compromise treatment outcomes in order to protect its profits," said Dr. Manica Balasegaram, executive director of MSF's Access Campaign. "Gilead is forcing medical providers to introduce policing measures that could lead to dangerous treatment interruption for patients."

- here's the MSF release

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