By Tim Fitzsimons
Corey Johnson, speaker of the New York City Council and one of the most prominent HIV-positive politicians in the U.S., called for the National Institutes of Health to exercise its “march-in” rights and break the patent held by Gilead Sciences to exclusively manufacture and market HIV prevention drug Truvada, or PrEP.
“As an HIV+ elected official, I have a responsibility to the activists who came before me who I believe literally saved my life, to those we have lost to the AIDS crisis, and to those who come after me to do everything in my power to end this epidemic once and for all,” Johnson said in a statement shared with NBC News. “The cost of PrEP in our country reveals something deeply rotten about our healthcare system, and the NIH needs to march in and break the patent immediately. This is life or death and there is no time to waste.”
Johnson is now one of the highest-ranking officials in the U.S. to endorse #BreakThePatent, a campaign run by PrEP4All, an HIV/AIDS activist consortium, that is pressuring the federal government to invoke a rarely used power in the Bayh-Dole Act, or the Patent and Trademark Law Amendments Act, to “march-in” and remove a pharmaceutical company’s exclusive right to market a drug.
According to the PrEP4All activists, the legal justification for breaking the Gilead patent for Truvada is in section 2 of the text of the law, which states that patents may be broken if the government feels “action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees.” Activists say Gilead’s high price shuts out many people who would benefit from the drug, a single daily bill that, when taken consistently, reduces the risk of HIV infection by nearly 100 percent.
In a statement emailed to NBC News, Gilead highlighted its patient assistance programs, which the company says reduces the cost of Truvada to under $5 for the majority of patients.
“Gilead’s extensive efforts to provide access to Truvada for PrEP (and even before as HIV treatment) clearly satisfy the Bayh-Dole requirement of reasonable efforts to make an invention (emtricitabine) available for health and safety needs,” Ryan McKeel, a Gilead spokesman, said. ” We believe that there is no rationale or precedent for the government to exercise march-in or other IP rights related to Truvada.”
But across the world, where generic Truvada has long been available, the cost for PrEP is roughly $25 per month. In the U.S., where only Gilead is allowed to sell Truvada under its exclusive patent, one year’s supply costs over $20,000, or about $1,700 a month.
Calling it a “bold first step toward dramatically increasing PrEP access in this country,” Christian Urritia from the PrEP4All campaign applauded Johnson’s support for breaking Gilead’s Truvada patent.
“With the savings from lowering the price of PrEP, we could fund a National PrEP Program that would enhance and expand necessary social services to high-risk communities and offer a robust funding mechanism to the organizations on the ground fighting the epidemic every day,” Urritia said.
Johnson noted in a statement that only 8 percent of the 1.1 million Americans who need the HIV prevention drug PrEP are taking it, and those who have access to it are largely gay and bisexual men, meaning many of the women who are at high risk of HIV infection are not taking PrEP. In New York City, where PrEP uptake is relatively high, the rate of new HIV infections has been declining for years.