Nothing for us without us!” In a spacious ballroom crowded with attendees at the AIDSWatch 2019 gathering in Washington, DC on April 1, HIV/AIDS activists chanted such slogans during the keynote address made by Centers for Disease Control and Prevention (CDC) Director Robert Redfield—a Trump appointee with a troubled record of alleged scientific misconduct and advocating discriminatory behavior towards people positive for HIV/AIDS.

“We’ve watched our friends get infected because they can’t afford a drug that costs $6 to produce,” shouts one of the activists in the video tweeted below, “and they [pharmaceutical giant Gilead] charge $2,000.”

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Plus Magazine@HIVPlusMag

activists challenges @CDCgov ‘s Robert Redfield on patents, , and the admin. @AIDS_United @UNAIDS @GMHC @PrideCenterPrEP

The protester, James Krellenstein, is a co-founder of PrEP4All Collaborations, which one of its other co-founders, Tom Blake, describes to Filter as “a group of grassroots activists who formed in response to Gilead’s egregious price gauging of PrEP.” The group is organizing to win universal access to pre-exposure prophylaxis (PrEP) medication that, when used daily, reduces the risk of new HIV infection by 90 percent.

For many, PrEP’s high costs are a significant barrier. Gilead does offer two financial assistant programs for consumers of its drug, Truvada, though the company has not disclosed data on the utilization of the programs.

“We support comprehensive payer coverage and maintain support programs for qualified uninsured and underinsured people in the United States who cannot afford their medications,” Gilead Public Affairs Senior Director Ryan McKeel told IPWatchdog in early March.

For PrEP4All, the programs are “inadequate” for ameliorating social, geographic and financial barriers faced by people of color, folks living in the South and women.

Truvada’s steep price tag does not correlate to its production cost, as the activist noted in the direct action. Instead, Gilead’s US monopoly on Truvada has led to prices skyrocketing. A Washington Post investigation published less than a week before the PrEP4All action found Truvada, an HIV prevention drug researched by studies funded by US tax dollars and patentedin 2015 by the CDC, made Gilead $3 billion in 2018 sales alone. The government saw none of that revenue.

Gilead has patents dating back to 2003 and 2004 for Truvada when it comes to treating people who already have HIV. But the CDC holds the patent on Truvada for PrEP, having first applied for its patent in 2006 after it was shown to work in primates. The Food and Drug Administration approved Truvada’s use for HIV prevention in humans in 2012, and that the same year, Gilead got the green light to begin marketing the drug as PrEP to consumers. According to the Washington Post report, the CDC approached Gilead in 2016 about licensing Truvada for PrEP to the company.

Upending Gilead’s corporate control over these “public assets”—as Christopher J. Morten, a patent expert and fellow at Yale’s Global Health Justice Partnership (GHJP), characterized the PrEP medication to The Washington Post—is PrEP4All’s organizing priority.

“Our short-term goal is for the House Oversight committee to hold hearings and investigate the CDC’s refusal to enforce the patents on PrEP that they already own,” as well as “any illegal agreements” between the government agency and the corporation, wrote Blake. “The American people deserve to know why these patents have been kept secret for so long and Congress has a responsibility to investigate. We have had positive initial conversations and hope to continue to engage with lawmakers this spring.”

PrEP4All is joined by GHJP in calling on the CDC to “recover lost revenue from Gilead’s patent infringement and use that money to fund a truly universal PrEP Program.” In a 2018 white paper, PrEP4All estimated that a national program would cost under $2 billion annually—which, according to them, is less than a tenth of what the federal government already spends on HIV care in the US. In the 2020 Fiscal Year budget, the Trump administration allocated $291 million to stop new HIV transmission and to treat existing diagnoses, $50 million of which will be put to funding PrEP services at Health Resources and Services Administration (HRSA) community health centers.

The coalition is also requesting that Congress set a maximum price of $15 per month for Truvada—instead of the existing $2,000 monthly rate—”by enforcing the patents the agency already owns.”

The PrEP4All activists who crashed the CDC director’s speech asked him whether the agency will “request a review of the CDC’s patents and Gilead’s production of Truvada as PrEP in order to obtain possible royalties from Gilead as resources to fund the HIV preventive portfolio and PrEP access.”

The director’s response? “Well, I know you are not going to like my answer,” Redfield said, according to the NY Daily News. “I can’t comment on any possible negotiations going on with any entity.”

The demands made by PrEP4All are legally reasonable, according attorneys from GHJP and Yale Law School’s Media Freedom and Information Access (MFIA) Clinic. “I have no reason to believe that these patents are not valid and enforceable, and moreover, they seem to be infringed [by Gilead] by the use of Truvada for PrEP,’’ Morten said.

At publication time, Gilead has not responded to Filter‘s request for comment.

“These patents give the CDC the power to bring prices down, because Gilead needs its permission to sell this drug,” said Amy Kapczynski, professor of Law at Yale Law School and faculty co-Director of GHJP.  “If the CDC asserted its patents against Gilead, the revenue generated [from Truvada royalties] could be used to fund a program to create universal access to PrEP within the United States, which could dramatically reduce new HIV infections.”

Author: SESSI KUWABARA BLANCHARD

Source: https://filtermag.org/2019/04/09/breakthepatent-activists-fight-for-universal-access-to-overpriced-hiv-medication/