HIV Aids

Advocates Are Unhappy with the Global AIDS Agenda’s Drug Patent Language

Every five years, reps from governments and advocacy groups around the world come together via the United Nations to haggle out a document, called a political declaration, that sets the global agenda on fighting AIDS for the half-decade to come. In 2016, for example, the document said that the world was aiming for fewer than 500,000 new HIV infections, fewer than 500,000 AIDS deaths, and no more HIV-related discrimination by 2020. As is often the case with these declarations, the goal was not met: In 2020 alone, about 1.5 million people seroconverted and nearly 700,000 died of AIDS.

Not that anyone is getting penalized for the failure. “There’s no punitive or enforcement power to this declaration,” says Eric Sawyer, a longtime U.S. HIV activist living with HIV and a former staffer on UNAIDS, the body within the U.N. that deals with AIDS. “It’s primary purpose is to act as an inspirational roadmap in getting governments to set targets for reducing deaths and new infections and getting a certain percent of people with HIV onto treatment.”

But, says Sawyer, “It’s inspired developing and middle-income countries to allocate some of their own national resources to the HIV response. And it’s a global advocacy tool because it’s an attempt to keep countries accountable” to do more against HIV. It also works in synergy with large programs fighting AIDS in multiple countries, such as the Global Fund and the United States’ own PEPFAR.

In other words, the document isn’t exactly law, but it still plays an important role in identifying certain baseline goals that advocates can push for within their own countries. Which is why, this year, those who support maximum loosening of pharmaceutical patents, in order to facilitate greater production and obtaining of HIV meds in middle- and low-income countries, came away greatly disappointed.

Rich Nations Scaled Back Patent Language

The original document—whose every provision is haggled over for days by a wide body of people representing the interests of individual countries, trade groups, and advocacy and humanitarian entities—included language, backed by representatives from developing countries, that would have greatly loosened language from the longstanding international agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS basically says that companies’ patent exclusivity must be honored for 20 years, with some exceptions (waivers) for international health crises such as AIDS and COVID. In the roughly 20 years since the possibility of waivers to TRIPS emerged, rich, middle-income, and poor countries have engaged in a tug-of-war (played out through intermittent negotiations, such as the UNAIDS declaration) over how much latitude middle- and low-income countries can have in overriding TRIPS in order to make their own less expensive version of drugs whose patents are still held by drugmakers in rich countries.

The short version of what happened with the latest UNAIDS declaration is that developing countries wrote in broad manufacturing freedom language that overrode TRIPS. The original draft of that language stipulates “an indefinite moratorium on international intellectual property provisions for medicines, diagnostics and other health technologies.” But rich countries—particularly the United States and those in the European Union—brought the baseline rules of TRIPS back into the language, agreeing instead to vague language saying that, despite upholding TRIPS, equal access to lifesaving meds worldwide would remain a priority.

That tortured addition reads: The use, to the full extent, of existing flexibilities under the Agreement on Trade-Related Aspects of Intellectual Property Rights specifically geared to promoting access to and trade in medicines, and, while recognizing the importance of the intellectual property rights regime in contributing to a more effective AIDS response, ensuring that intellectual property rights provisions in trade agreements do not undermine these existing flexibilities.”

Such was the version that was passed on June 8. “It provides cover for the E.U. and other countries fighting against TRIPS when it comes to COVID vaccines,” says Annette Gaudino, director of policy strategy at Treatment Action Group (TAG). Like many advocates for global drug access equity, she’s unhappy with the language. “It’s a public statement from global stakeholders that defends the patent status quo.”

When it comes to AIDS, she says, low-income countries may not feel the blow because they often already get extremely cheap versions of generally up-to-date HIV drugs via huge charity programs like the Global Fund and PEPFAR. “But it really harms middle-income countries because they’re not eligible for super-cheap drugs under things like PEPFAR,” she says, “and because they can’t afford the branded drugs. And more countries are moving up into that middle-income bracket.”

Gaudino was among advocates who found the U.S. pushback on the loosening “confusing and disappointing” (as she told the New York Times) because, recently, the Biden administration—in a sharp reversal from previous pro-patent U.S. policy—has said clearly that it supports loosening TRIPS rules regarding COVID vaccines, to make them more globally accessible.

She told TheBody that she, along with many other observers, had the impression that administration figures close to Biden, such as U.S. Trade Representative (USTR) Katherine Tai, may not even have been in touch with mid-level U.S. reps on the UNAIDS declaration—a relatively low priority at a time when world powers are haggling out COVID vaccine issues. Hence the mixed messaging, with Biden’s inner circle singing the COVID-era global-health-equity tune and lower-level trade reps—such as Sofija Korac, a human rights and health adviser in the U.S. delegation to the UN who was negotiating the declaration on behalf of the U.S.—singing a more traditional patent-protecting tune. (Korac did not reply to an email from TheBody asking for clarity about who, on the U.S. side, was pushing for traditional patent protections.)

Then again, says Gaudino, the U.S. could be sending a clear message: “That it’s supporting TRIPS [loosening] on COVID vaccines only, and it’s not about to take a serious and broad look at the patent system’s impact on global health. There’s still a broad underlying feeling that patents are good, and it’s not listening to [the plight of middle-income countries like] South Africa and India.”

Sawyer showed TheBody emails between him and Anthony Fauci, M.D., director of the U.S. National Institute of Allergy and Infectious Diseases, in which Sawyer was asking Fauci to get the message to Biden’s inner circle that U.S. reps on the UNAIDS declaration should be more progressive in their patent language. Sawyer says he thinks Fauci was unable to deliver that message in time.

One well-known advocate close to the negotiations said, anonymously in order to be totally blunt, “My very educated guess is that the USTR is stocked with lawyers and officials whose entire life has been pushing a maximalist intellectual property agenda [under all the previous administrations], versus Tai, who is really out there leading a significant shift in U.S. policy. I’m pretty sure it wasn’t Tai who decided to oppose the UN language, but rather middle-level people, and the stance never made it up to Tai.”

And yet again: Does the declaration even matter? “It does,” says Matthew Kavanagh, Ph.D., director of the Global Health Policy and Politics Initiative at Georgetown University and member of an advisory group to UNAIDS leadership. Kavanagh continues, “We’re at a moment of reckoning when it comes to the role of patents in pandemics. With vaccines, intellectual property is really bad and damaging. The patent system has not incentivized the delivery of either vaccines for COVID or long-acting injectable HIV treatments for most of the world.”

Many global HIV advocates have pointed out that those most likely to benefit from long-acting injectable treatments are folks in poor countries; Cabenuva, the first-ever long-acting injectable, was only recently approved in the U.S. “The best candidates for that,” says Kavanagh, “are not white gay men in New York City—it’s a young woman not disclosing her HIV status in southern Africa because she’s worried her husband will beat her if he finds out. Or a sex worker with no place to store their pills.”

Sawyer says that the narrow language around patents is a huge missed opportunity. “Had there been language in there [that was] agreed on by all member states that patents should be loosened for meds for HIV, TB, and hepatitis, it would’ve been a green light for countries to apply for compulsory licenses [that overrule patents] to produce them—and to have the [originating drugmakers’] data and tech transferred to them for a royalty. But without that kind of statement, there’s no chance in hell that would happen.”

Other Sore Points With the Declaration

A second stress point during negotiations was about language urging countries to do more to decriminalize and destigmatize the behavior of so-called “key populations”—traditionally marginalized or persecuted groups such as men who have sex with men, sex workers, transgender people, and people who use drugs—who are generally at higher risk for HIV. A new report written by Kavanagh and his Georgetown colleagues shows that countries that decriminalize such groups have higher success rates for fighting HIV. The U.S. was among countries pushing for strong language in the UNAIDS political declaration calling for countries to do so, as well as to empower women and girls around education and reproductive health.

But such countries got strong pushback from conservative nations, including China, Russia, Iran, and the Africa Group (a coalition of 54 African Union member states within the UN) to drastically dial back that language—and assert “the sovereign rights of member states.” What the declaration was left with, says Sawyer, was “aspirational language about addressing these issues, but no specific statements saying countries that criminalize these things need to take those laws away.”

According to Sawyer, “Russia had the biggest impact on the declaration, all of which was negative, limiting rights, protections, and access to essential services. They pushed back against decriminalizing key populations, drug use and harm reduction, sex work, trans issues, LGBTQ issues, sexual reproductive health and rights, and comprehensive sex ed.”

Advocates from many countries were dismayed by those limitations. “We’ve backtracked this time,” wrote Jacqueline Rocha Côrtes, a Brazilian HIV and human rights activist who participated in the declaration process, in an email to TheBody. “It is unbelievable that in the 21st century, there are countries that insist on denying the existence of people like gays, transgender [people], prostitutes, and drug users through the establishment of punitive, restrictive and discriminatory laws. Due to religious ideologies or … cultural issues … [countries] still reject that sex education programs … are central factors for an inclusive, comprehensive, universal, and egalitarian response to AIDS.”

Still, upon the negotiations’ close, UNAIDS officially called the declaration “new, ambitious, and achievable,” in part because it includes “new targets to ensure that 95% of people at risk of HIV use combination HIV prevention services [and] a greater emphasis on community-led provision of services—including a target to ensure that 80% of prevention services for key populations are provided by communities.”

Yet many advocates say the biggest loss was around patents. “The declaration makes it clear that there’s still everything to fight for,” says Gaudino. “We got a narrowing of the debate around patents, whereas what we needed was broad and bold thinking.”

And some global advocates said they saw a certain hypocrisy in rich nations’ fomenting a pushy, progressive stance toward human rights in developing countries while holding fast to patent protections. “The fact that the otherwise supportive and human rights–professing countries also resisted patent waivers and TRIPS flexibilities clearly shows that rich countries with developed pharmaceutical markets put money over life,” read an email to TheBody from Sonal Mehta, regional director in Bangkok for the International Planned Parenthood Federation, who was among the civil society members weighing in on the declaration.

“India, South Africa, and Brazil tried hard,” the email continued, “but it is frustrating to see the double standards of many developed countries. They want the global South to change laws, adhere to 95-95-95 [diagnosis, treatment, and viral suppression targets for ending their HIV epidemics], and include comprehensive sexuality education. But when it comes to TRIPS, the so-called developed global North gangs up and immediately resists the same and brings arguments of how it is important to ‘encourage’ companies to make new drugs! It is disappointing and sad that, on one hand, countries point fingers at human rights abuse of other countries—and when it comes to their turn, they quickly hide behind their capitalist, money-making lobbies.”

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