The global health community has once again found itself in a familiar position: fighting the U.S. on a policy previously seen as a no-brainer.
The fight against tuberculosis, the world’s top infectious killer, has been consuming United Nations negotiators for the last two months as they prepare for the first U.N. high-level meeting on the disease, scheduled for Sept. 26. Tuberculosis kills three people a minute worldwide, and its increased drug-resistance is making it more dangerous than ever ― and this effort toward a U.N. declaration has been seen as a potential turning point in building the political will and commitment to fight it.
Despite being the top single-country funder by far in the worldwide fight against TB, the U.S. is on the defensive as other member nations push standard access-to-treatment language in a proposed declaration on fighting TB.
Echoing recent moves by the U.S. delegation ― such as its resistance to a breastfeeding resolution this year, and lesser-known fights over livestock antibiotics and sugary-drink taxes ― the U.S. has ended up taking a solitary stand for the pharmaceutical industry over TB patients, experts say.
They say the U.S. aggressively sought to water down language that gives governments the option to allow generic versions of patented TB drugs through “compulsory licensing” in the interest of public health and access. Advocacy groups say it gives patients better treatment access by making medicine more affordable, but the pharmaceutical industry argues it breaks patent law and kills innovation.
“How is it possible that global leaders will gather for the first time to decide how to tackle the world’s most deadly infectious disease killer, and yet some countries backed by their Big Pharma lobbies are pushing to remove any mention of the need for vital medicines to be affordable?” Sharonann Lynch, an adviser to Medicines de Frontier’s Access Campaign, said in a statement.
While similar language about access to medicines was included in a 2016 U.N. declaration on antimicrobial resistance, experts say that such “compulsory licensing” moves, covered under a World Trade Organization agreement on intellectual property rights, have fallen under threat in recent years in various global declarations. For instance, Colombia’s attempt to use such compulsory licensing for generic medications saw pushback from the U.S. trade representative this summer, according to STAT.
So the threat being used in this fight, according to Leonardo Palumbo, another adviser to Medicines de Frontier’s Access Campaign, is that the U.S. would refuse to sign the declaration ― much like it refused to sign the recent Group of Seven joint statement and withdrew from the U.N. Human Rights Council.
That would be a huge loss in the political momentum needed in the fight against TB, and it would weaken the declaration’s impact, considering the traditional leadership role of the U.S., according to Palumbo.
“According to recent reports, the United States government’s funding for global TB [research and development] makes up almost 60 percent of the world’s investment,” a U.S. representative said during a recent U.N. hearing to discuss the declaration. “We would like to take this opportunity to point out that most existing treatment drugs for TB are off patent and inexpensive and that of the two newer drugs, one is donated and the other currently has limited use according to WHO guidelines.”
Lucica Ditiu, executive director of the international Stop TB Partnership, acknowledged the U.S.’s point ― the language about access is not very useful considering the current limited field of TB drugs. However, she stressed that she’d love nothing more than for such language to be needed ― it would mean that more new drugs, instead of the limited options now, were available to combat TB.
We will never stop protecting America’s engine of innovation because it drives the development of such treatments in the first place.
A U.S. Department of Health and Human Services spokesperson
Ultimately, the debate appeared to be at an end Tuesday as the declaration was set to become final. Experts and advocates told HuffPost that they see two major failings: the lack of a framework for independent accountability (developing countries thought it would lead to policing from donor countries) and a compromise on access-to-medicines language.
But South Africa ― one of the countries hardest hit by TB ― was so unhappy with the final draft that it threw the entire process into disarray by breaking the “silence period” ― a U.N. procedural protocol of not sharing the document until it is final. This made the declaration text public in the hopes of opening up negotiations again. Every global health expert HuffPost spoke to said such a procedural gambit was exceedingly rare.
Palumbo said the U.S. and South Africa are at a standoff. For South Africa, the access-to-medicines language was a red line, Palumbo said.
Experts are at a loss on what’s next ― the timeline and negotiations on the declaration have been thrown into disarray.
The best-case scenario, some argued, would be if South Africa convinced the U.S. to add stronger language on access to medicine at the expense of stronger language about accountability. The worst-case scenario involves everything now being up for grabs to renegotiate.
“You can see how oftentimes these negotiations can be a race to the bottom, and it’s definitely regrettable that [more accountability and access-to-medicine language] weren’t included,” Palumbo told HuffPost. He added, though, that he hoped this provided a window of opportunity for countries such as Brazil, Russia, India and China to join South Africa in pressing for stronger language on access to medicine.
When reached for comment late Wednesday night, a spokesperson for the U.S. Department of Health and Human Services told HuffPost that, although America’s commitment to combating TB was unquestionable considering its leadership role in funding and access, the Trump administration planned to maintain that leadership while also “protecting American ingenuity and innovation” and insisting on the “basic protections of intellectual property.”
“The Trump administration will continue to work with partners to make affordable medications even more accessible,” the HHS spokesperson said. “And we will never stop protecting America’s engine of innovation because it drives the development of such treatments in the first place.”