Gilead Anti-Diversion Program for Hep C Medicines Throws Patient Rights under the IP Bus

Professor Brook K. Baker, Health GAP senior policy analyst

March 24, 2015

MSF has leaked information concerning Gilead's licensing negotiation with 11 Indian generic companies that have received authorization to manufacture and sell Gilead's promising new oral hepatitis C medicines in 91 designated countries. The latest negotiations involve an "anti-diversion" demand from Gilead that generic licensees collect personal information on patients receiving the Hep C medicines including name, proof of residence, and proof of citizenship as a condition of dispensing the medicine.

Ordinarily, drug companies do not gain access to confidential patient information merely because they have patent rights and marketing rights for their medicines. Ordinarily, like in the U.S., individualized patient information is highly confidential and neither medical providers or pharmacists can supply this kind private information to third parties. So what gives - why is Gilead seeking this information and can it get away with it?

Gilead's licenses at present allow sales in particular countries/territories. This is consistent with the nature of patent rights themselves, which are territorial. Patent rights don't give companies to right to decide who gets to buy a medicine in a country. Foreigners and non-citizens in the country can buy, as can persons with no fixed address. By requiring proof of identity, address, and citizenship, Gilead appears to be setting the stage to deny or limit sales to to non-citizens and/or to medical tourists, who they hope to exploit for higher prices in their home countries. Of course, the Gilead provision also adversely affects many displaced persons, migrants, legal outsiders, and unhoused persons who might lack the required information.

In addition to requiring privileged and confidential information from medical providers up front, Gilead is also trying to require generics to ensure that licensed distributors dispense only one bottle of Hep C treatment at a time to personally identified patients, even though the normal course of treatment requires 3-6 bottles. So patients need to return the empty bottle physically or by courier in order to receive the next month's treatment. These "verification of use" procedures undermine both patient autonomy and patients' adherence to treatment. Of course, these requirements also help to weed out medical tourists who might find it unaffordable to stay 6-12 weeks in another country merely to get treatment, even highly discounted treatment.

In sum, through its draconian anti-diversion policies, Gilead is throwing patient rights under their IP bus. With what should be forbidden information, Gilead is hoping to prevent treatment access for richer patients from other countries and all other forms of product diversion to rich markets. Patients get caught under the wheels as their privacy and autonomy rights are sacrificed on the alter of Gilead's search for profits rich- and middle-income country markets.

There are solutions. Generic companies could simply refuse to collude in this unethical practice. Moreover, licensing terms are also reviewable at least in some countries with respect to the reasonableness and anti-competitive impact of licensing terms. These terms might also be challengeable in many countries pursuant to the medical information confidentiality laws. Finally, public pressure can and should be brought to bear against Gilead for this ghastly infringement of patient rights.

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