Nationwide only 8 percent of an estimated 1.1 million potential candidates for PrEP have access to this life-saving drug
Acting Public Advocate and New York City Council Speaker Corey Johnson, Council Member Carlina Rivera, Assembly Member Dick Gottfried, former State Senator Tom Duane, founders of the PrEP4All Collaboration (and organizers of the #BreakThePatent campaign), and advocates held a rally to call on the National Institutes of Health (NIH) to exercise its march-in rights and break Gilead’s patent of Truvada, the brand name medication for pre-exposure prophylaxis, also known as PrEP. March-in rights, as granted by the Bayh-Dole Act of 1980, allow the federal government to break patents in certain cases involving patents that resulted from publicly funded research. Breaking the patent in this case would make PrEP more affordable and accessible by allowing generic versions to enter the market.
“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,” said Acting Public Advocate and Council Speaker Corey Johnson. “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.”
“Gilead Sciences’ 250 times markup on Truvada as PrEP, a publicly funded invention, is an egregious instance of special interests trumping the public health needs of the American people,” said Christian Urrutia, co-founder of the PrEP4All Collaboration. “By endorsing the #BreakThePatent campaign, Speaker Johnson and New York City has set a bold example for the nation on addressing the domestic HIV epidemic and combating the greed of pharmaceutical companies. If we are serious about ending the HIV epidemic in the United States, the Government must invoke march-in rights, dramatically lower the price of PrEP, and use the savings to fund the organizations on the front lines that can implement a universal PrEP program.”
PrEP has been shown to reduce the risk of HIV infection in people who are high risk by up to 99 percent, but access is limited due to its exorbitant cost. Among the estimated 1.1 million people nationwide who are potential candidates for PrEP, only 8 percent are receiving it, and access has been largely limited to white gay or bisexual men, meaning that many groups with the highest risk of infection are not benefiting from this life-saving drug.
Currently, Truvada is the only brand of PrEP medication available until at least 2021 when the first generic version of the medication becomes available, and 2024 when all generic versions will be available for sale. The drug, which was developed through research funded almost entirely by the National Institutes of Health (NIH) and rakes in billions of dollars in annual global revenue for Gilead Sciences, carries a list price of close to $2,000 for a 30-day supply, compared with an average monthly cost of as little as $6 to produce.
The #BreakThePatent campaign urges the NIH to use its ability, through the Bayh-Dole Act of 1980, to march-in and break Truvada’s patent. #BreakThePatent argues that the NIH would be well within its rights to do so in this case since the patent holder, Truvada, is failing to acknowledge health or safety needs of consumers by making the drug so expensive that access to it is limited. Acting Public Advocate and Speaker Johnson and those at the rally joined the #BreakThePatent campaign in urging the NIH to exercise its march-in rights to break Gilead’s patent on Truvada and allow generic versions of PrEP onto the market, making the drug available and affordable to all.
“As Chair of the Committee on Hospitals, I call on NIH to step in and #BreakThePatent on PrEP,” said Council Member Carlina Rivera, Hospitals Committee Chair. “For years, Gilead has put profits over patients, even though PrEP can reduce the risk of HIV transmission by more than 99 percent. I commend Speaker Johnson for his commitment to end HIV in New York City, but we will never be able to solve this epidemic unless the federal government finally steps in and allows for a generic PrEP drug that is affordable for all New Yorkers.”
“Gilead’s morally bankrupt mark up of Truvada is as clear a case of putting profits over patients as there is,” said Council Member Mark Levine, Health Committee Chair. “As President Trump continues to follow his empty calls to end HIV with actions antithetical to that goal, we need to do everything we can to ensure the 1.1 million PrEP eligible Americans have access to this vital mediation. I’m proud to stand with Speaker Johnson in calling for the NIH to #BreakThePatent and I’m grateful for his leadership in standing up to Gilead Sciences.”
“The patent and exclusivity over Truvada, which has proven to be extremely effective in preventing the transmission of HIV, has made the drug unaffordable to people who need it. Its exorbitant cost can be beyond the amount covered by insurance and health plans, therefore limiting its access and potentially hindering the fight to reduce HIV levels. It’s time to #BreakThePatent,” said Council Member Ritchie Torres.
“Gilead’s greed is well documented, and it’s past time we stop allowing this pharmaceutical company to profit off life-saving miracle drugs the taxpayer funds. Today it’s Truvada, but yesterday it was Sovaldi, a drug that basically cures hepatitis C – if you can afford to pay $1000 per pill. This is greed that kills and it’s crazy we put up with it, especially since other countries are fighting back and winning. It’s time for the US to do the same. The NIH must exercise its march in powers, break Gilead’s patent, and stop the company’s greed from causing thousands of preventable deaths,” said Council Member Carlos Menchaca.
“PrEP is the most effective medication to prevent HIV infection. It’s available for about $100 a month or less in almost every country in the world – except the U.S., where it costs about twenty times as much, and the manufacturer has been steadily increasing its price every year. Only about 10% of Americans at substantial risk for HIV are actually taking PrEP. The federal government should use its legal power to break the patent monopoly so we can end the HIV epidemic in America,” said Assembly Member Richard N. Gottfried, Chair of the Assembly Health Committee.
“Breaking Gilead’s patent of Truvada will help New Yorkers and Americans across our country get access to generic, more affordable versions of this critical, life-saving medicine,” said State Senator Gustavo Rivera, Chair of the Senate Health Committee. “I stand firmly with Speaker Johnson in calling out this immoral monopoly that is profiting from the serious healthcare needs faced by millions of Americans across the country who are trying to make responsible healthcare decisions and protect themselves from contracting HIV.”
“PrEP provides up to a 99% reduction in HIV risk but costs $2,000 a month, making it too expensive for many New Yorkers,” said State Senator Brad Hoylman. “A drug doesn’t do much good if people don’t take it. I’m proud to stand with Speaker Johnson, activists and medical professionals across the country who are fighting for a generic version of this crucial treatment.”
“It has been shown that allowing for generic versions of medications to be available in the pharmaceutical market enables greater access by the public because of reduced cost. In the case of pre-exposure prophylaxis medications like Truvada, the pharmaceutical manufacturer, Gilead, is preventing many in need from accessing a medication that can prevent the spread of HIV. A medication that has been tested, approved by the Federal Drug Administration, and has been on the market for a number of years should not be withheld simply for profit. I support breaking Gilead’s patent in the interest of public health,” said Assembly Member Deborah J. Glick.
“As stated in its mission statement, a goal of the NIH is ‘to help prevent…disease,’” said former State Senator Tom Duane, the first openly HIV+ Member of the New York State Legislature. “The NIH must use its authority to make sure that PrEP is available — immediately — to anyone and everyone at high risk of contracting HIV.”
“To end AIDS as an epidemic in New York, we need to nearly triple the number of people using PrEP across this state, and dramatically increase the percentage of PrEP users who are low income. Drug pricing reform is vital, as is shoring up our HIV infrastructure with any savings from lower drug prices, so that it can adequately deliver PrEP services,” said Charles King, CEO of Housing Works.
“We cannot afford to lose another generation of young Americans — particularly young gay men of color and transgender women — to the HIV pandemic, especially since we’ve had Truvada for pre-exposure prophylaxis (PrEP) approved by the U.S. Food and Drug Administration (FDA) for this use since 2012,” said Mark Harrington, Executive Director of Treatment Action Group (TAG), the New York-based HIV, HCV, and TB research and advocacy group. “U.S. taxpayers funded the research which led to FDA approval of PrEP while the monopoly manufacturer still charges $24,000 per year or more for Truvada. High drug prices contribute to the lack of access to affordable PrEP which keeps new HIV infection rates unacceptably high, when we should all be working together to drive those new infection rates down. Ending the epidemic in New York depends on reducing the price of PrEP so that everybody who needs it can get it to end the epidemic.”
In 2017, there were 2,157 new HIV diagnoses in New York City. This represents a slow but steady decline since 2013, which saw 2,898 new HIV diagnoses. Since 2013, the number of new HIV diagnoses in the city decreased across all genders and races. However, according to the Centers for Disease Control and Prevention (CDC), across the country gay, bisexual men, and transgender women are the populations most affected by HIV, with black/African-American gay and bisexual men accounting for the largest number of new HIV diagnoses in 2017 followed by Hispanics/Latinos. Sex workers are also disproportionately affected. The same holds true here in NYC.
While no cure exists for HIV, advances in science mean that people today have more tools than ever to help prevent HIV. Acting Public Advocate and Speaker Johnson believes that expanding access to PrEP is one of the most important steps still to be taken in the fight to ending the AIDS epidemic.