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Drug-Company Patents vs. the Public Good: Should the NIH Break This Medication Patent?

Should a biotech giant holding a valuable patent be forced to give it up if doing so would serve the public good? That’s the mounting debate over Gilead Sciences’ hold on an HIV prevention treatment, which some say is too expensive and should be available to all.

Truvada, which is made by California-based Gilead Sciences, is the only drug approved by the United States Food and Drug Administration (FDA) for pre-exposure prophylaxis, or PrEP, a course of treatment that can help reduce the risk of contracting HIV. The U.S. Centers for Disease Control and Prevention (CDC) says that PrEP is more than 90% effective when the pill is taken regularly. But Truvada is expensive, in large part because it is still under patent and costs have spiked to nearly $2,000 a month in the U.S. (By comparison, Truvada costs around $100 a year in other parts of the world where its patent was not extended. In February, New Zealand announced it would publicly fund Truvada, making it nearly free.) Truvada is covered by insurance, and Gilead runs a coupon program to lower the cost of the regimen. But even still, in the U.S., there’s an increasingly loud chorus demanding that Gilead make Truvada more affordable and accessible—or that federal regulators should step in.

One proponent of the move is New York City Council speaker Cory Johnson, who has repeatedly called for the federal government to break Gilead’s patent on the drug. Johnson, who is HIV-positive and tested positive roughly a decade before PrEP was developed, spoke with WBUR’s Here & Now on Monday to reiterate his stance that the National Institutes of Health could use a 1980 law, the Bayh-Dole Act, to break a patent on a drug developed from research at least partially paid for by federal funds. Johnson, one of the few openly HIV-positive elected officials in the nation, noted, “I feel like I’m doing this and all the activists are doing this really on the shoulders of all of those that came before us.”

Johnson’s support bolsters the #BreakThePatent campaign that has been growing for a while now. Members of the New York chapter of ACT UP (AIDS Coalition To Unleash Power) staged protests in early 2018 against Gilead, demanding the drug company make Truvada more accessible. ACT UP, which was founded in the 1980s as a response to government inaction during the AIDS epidemic, is known for pushing the FDA and CDC to fast-track the approval process for HIV medication and expand drug trials to include individuals at all stages of HIV infection.

Though unlikely allies on most issues, ending the AIDS epidemic in the U.S. is perhaps one public health matter on which an array of activists and lawmakers agree. During his 2019 State of the Union address, President Donald Trump called for the eradication of HIV in the U.S. by 2030. But Trump has a mixed record when it comes to supporting public health programs that would push down the HIV rate, including proposing changes to Medicare that would hit HIV-positive seniors especially hard, and firing all members of the Presidential Advisory Council on HIV/AIDS in 2018. In February 2019, he reauthorized PEPFAR, the President’s Emergency Plan for AIDS Relief, through 2023.