Breaking the HIV Prevention Monopoly

By Rhoda Feng

In 2007, federal scientists made a startling discovery: An HIV treatment showed signs of preventing new HIV infections in monkeys. The U.S. government funded clinical studies to confirm the medicine’s effectiveness for pre-exposure prophylaxis (PrEP) and obtained patents on this breakthrough.

Yet, many years after its approval for PrEP, Truvada still remains priced out of reach for the taxpayers who helped fund its development.

Public Citizen is calling on the government to act and for lawmakers to investigate.

Although Gilead Sciences developed Truvada to treat HIV and got FDA approval of the drug in 2004, the corporation didn’t pay for any of the original research that led to the new use of Truvada: HIV prevention.

Using Truvada to prevent HIV infections—Truvada as PrEP—was developed using at least $50 million in federal grants. Truvada manufacturer Gilead charges more than $2,000 a month for the drug, which costs less than $6 per month to manufacture.

“As with many new medicines, taxpayers pay twice: first through public funding of research and development, then for the monopoly prices the companies set after acquiring the rights to the drug,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines program.

In February, President Donald Trump announced his plan to eliminate HIV transmission by 2030. Achieving this goal would require either greatly increasing government spending or significantly reducing medicine prices. But the administration has done neither.

Approximately 40,000 new HIV infections are reported every year, according to the U.S. Centers for Disease Control and Prevention (CDC). Truvada has been shown to be up to 99% effective at preventing the spread of HIV, but its price tag puts it out of reach for more than 90% of the 1.2 million Americans at high risk for exposure to HIV.

In 2018, the company made $3 billion in sales on Truvada and has consistently increased the price of the drug since its approval for PrEP in 2012. The PrEP patents, which were uncovered by HIV activists running a PrEP4All campaign, represent a potential multibillion-dollar funding stream for the CDC.

Public Citizen has supported and advised the campaign and in April, signed on to a letter by the PrEP4All activists calling on the director of the CDC and Assistant Secretary for Health Brett Giroir to:

  • Use government patents protecting the use of Truvada as PrEP for the benefit of the American people. Any licensing agreement must require that Gilead dramatically reduce the price of Truvada and provide the drug at cost to public health programs.
  • Increase access to Truvada in communities where PrEP is underused, such as communities of color, and fund existing community health centers providing HIV prevention services.
  • Disclose to the public any and all communications between the CDC and Gilead Sciences.
  • Involve all communities vulnerable to HIV in all future discussions and potential settlement agreements with Gilead.

Public Citizen has helped PrEP4All activists call on lawmakers to act. In May, the U.S. House Oversight and Reform committee held a hearing on Truvada’s pricing. Public Citizen sent the committee information highlighting the systemic failure of the U.S. government to demand affordability for federally funded inventions and pointing out that patent royalty payments from Gilead alone could fund a universal PrEP program to dramatically reduce the number of new HIV infections in the country.

“We have the technology to end AIDS in this generation,” said Maybarduk. “Indeed, the U.S. government in part owns that technology. It is in our power to ensure that corporations make it available to everyone who needs it. The Trump administration must make it happen.”