The fight for universal access to PrEP medication for HIV prevention was picked up by Vermont Senator and presidential hopeful Bernie Sanders, as well as six other senators. In a major advance for the #BreakThePatent campaign, on which Filter has reported, these seven senators sent an April 23 letter to leaders of Health and Human Services (HHS) and the Center for Disease Control and Prevention (CDC), calling on them to provide greater transparency regarding pharmaceutical company Gilead’s alleged patent infringement on, and price-gouging of, a medication that has the potential to drastically reduce new HIV infections.
The senators write that they are “deeply concerned” about the alleged patent infringements—particularly because they are “selling it at a price that makes the drug unaffordable for many Americans.” And they inquire about the measures that HHS and the CDC have taken to ensure that “government-held patents”—like the one for the use of the drugs emtricitabine and tonovir for pre-exposure prophylaxis (PrEP) against HIV—are “properly licensed.”
Formerly undisclosed, the Department of Justice (DoJ) launched an investigation in April into “the facts about the strength of the government patent,” as The Washington Post reported. The DoJ lawyer who visited the CDC on April 16 to fact-gather told the Post that the government does not intend to sue Gilead over the dispute. The pharmaceutical company has also refused to pay royalties to the government.
For the PrEP4All activists driving the #BreakThePatent campaign, that’s a problem. “If they are going to patent Truvada, the US government should have [been] collecting royalties since the very beginning, to invest back into the tax payers whose money was used to develop the drug in the first place,” wrote PrEP4All co-founder Emily Sanderson in an email to Filter.
Currently, Gilead charges over $2,000 a month for a drug that costs less than $4.50 per month to manufacture, raking in $3 billion from Truvada last year alone—and that’s only been increasing over the years. This “potential multi-billion dollar funding stream,” as the collective described in a recently-issued list of demands signed by over 40 organizations, could go towards making PrEP available to anyone who needs it. Right now, less than 10% of the people who need PrEP are using it, according to the CDC.
To be clear, the high price of Truvada is not the only barrier to access for many people. Other obstacles include the “persistently high uninsured rate, the abysmal state of trans-affirmative health care options in most of the country, and a lack of trusted and affordable healthcare providers in rural communities and communities of color,” described Sanderson.
But while a much broader systemic overhaul is required to eliminate other barriers, Gilead’s pricing is a good first step, according to PrEP4All. The activist coalition demands that Gilead “dramatically reduce” the price of Truvada—specifically to “a maximum price of $15 per month.” PrEP4All’s proposed price ceiling is still far higher than The Global Fund’s Pooled Procurement Pricing Mechanism Reference Price for the drug, which was agreed upon by manufacturers of these drugs in order keep prices low and make sure a comprehensive supply of the medicines is available to consumers.
Additionally, public health programs should receive supply of the drug at no cost, while the government’s royalty revenue should go to funding a National PrEP Access Program, as outlined in PrEP4All’s July 2018 white paper.
“Think of how many people could have taken control of their sexual health had there been a PrEP access program since 2011, when these royalties could have started being collected,” wrote Sanderson.
Gilead is expected to respond to the senators’ requests by May 7; in the meantime, PrEP4All plans to be on the 2020 campaign trail, turning the spotlight on presidential candidates’ plans–or lack thereof– to end new HIV infections.
“Big Pharma’s price gouging has been a major barrier to HIV treatment and prevention since the beginning of the AIDS crisis. Then, it was Burroughs-Wellcome, now it’s Gilead Sciences,” wrote Sanderson. “Unfortunately, 30 years after the start of the epidemic we are still fighting pharmaceutical companies to protect the health of marginalized groups, including people with HIV.”
In order to tackle the epidemic, “Every single member of Congress should be talking about the cost of PrEP and ending AIDS,” Sanderson urged. For PrEP4All, ending preventable HIV/AIDS deaths “requires a seat at the table and signs in the streets.”
Photograph: Bernie Sanders via Flickr