The Trump administration, fresh off its battle against breastfeeding at the United Nations, is once again pressuring countries to revise a U.N. public health resolution, this time focused on tuberculosis.
The U.S. is seeking to remove language asserting the legal right for developing countries to override drug industry patents and license low-cost versions of otherwise expensive TB medicines, arguing over the wording of a draft declaration for a high-level meeting on tuberculosis scheduled to take place in September.
But in this effort, the administration has an unlikely ally: a former Obama administration senior adviser who has criticized Trump.
Josh Black was the White House director for U.N. and Multilateral Affairs under Barack Obama in 2016. A career diplomat and sanctions negotiator, he served in the State Department under three presidents, but quit this January amid “growing disillusionment” with the Trump administration.
Black now works as the point person at the U.N. for the Pharmaceutical Research and Manufacturers of America, or PhRMA, the nation’s main drug industry lobbyist. And the U.S. meddling on the tuberculosis declaration aligns with PhRMA’s stated desire to protect corporate patents.
It’s not exactly surprising to see continuity among Democratic and Republican presidents on drug patents. The Obama administration repeatedly fought nongovernmental organizations over access to affordable drugs in the developing world, advocating for higher prices and pressuring poorer countries to stop creating generics. “This isn’t something unique to the Trump administration,” said Leonardo Palumbo, an advocacy manager with Médecins Sans Frontières, which first raised concerns about the TB resolution.
The famously loyal Trump operating hand in hand with someone who worked for his heated rival Obama and condemned his leadership is an anomaly. In the rarefied world of global pharmaceutical profits, however, it’s just par for the course.
The Trump administration courted controversy last month when the New York Times reported that it opposed a resolution supporting breastfeeding at the World Health Assembly. The U.S. reportedly threatened countries with trade sanctions and withdrawal of military aid if they introduced the resolution, and later sought to soften the resolution’s text. The aggressive action aligned with the interests of the $70 billion infant formula industry, which has thrived on providing misinformation about breastfeeding to the developing world.
At that same World Health Assembly, countries gathered to prepare for the first U.N. General Assembly high-level meeting on tuberculosis, which was announced in December 2016. Tuberculosis is the world’s leading infectious disease killer and the ninth leading cause of death worldwide, killing 1.674 million people in 2016, per the World Health Organization’s most recent report. Over half of the 10.4 million new cases that year came from just five countries: India, Pakistan, Indonesia, China, and the Philippines. And new strains of drug-resistant TB reached 600,000 people last year, suggesting a continuing struggle.
Most TB deaths are preventable with early detection and treatment. But the drugs necessary to treat TB are costly, particularly the multidrug-resistant strain. “The average regimen can cost up to $2,000,” said Palumbo.
In 2013, Johnson & Johnson developed bedaquiline, the first new TB treatment in 40 years, but other than that and Japanese manufacturer Otsuka’s delamanid, breakthroughs have been scarce because it’s hard to get a drugmaker to see the profit in creating medicines to eradicate a disease that primarily affects poor countries. And these drugs have suffered from slow scale-up; MSF estimated in February that less than 5 percent of those afflicted with TB had access to the new medicines.
A donation program runs out next year, which could lead to even higher prices. The high-level meeting is intended to guide the global response to TB, with the goal of wiping it out. And civil society groups had one major priority: reaffirm the right for all countries to legally ensure access to affordable TB treatments.
Under the 2001 Trade-Related Aspects of Intellectual Property Rights, or TRIPS, agreement worked out at a World Trade Organization meeting in Doha, Qatar, all countries can use “compulsory licensing” to rip patents away from drug companies and produce low-cost versions that increase competition. As Palumbo explains, this flexibility was used to reduce the cost of HIV medications by 99 percent over a 20-year period. “Ensuring intellectual property rights should not be a barrier for wider access to medicines,” Palumbo said.
Again, this is allowable under international trade law. Global society has agreed that countries’ lack of wealth shouldn’t force them to suffer with epidemics that kill citizens on a mass scale, for the sake of a profit margin on a drug company spreadsheet.
But when negotiations ramped up in June, the U.S. rejected this reaffirmation. According to an early draft reviewed by The Intercept, the U.S. objected to paragraphs that specifically cited the TRIPS agreement and the rights of countries to put access to medicines for all above intellectual property concerns. Instead, the U.S. wanted to soften the references to TRIPS, and demanded inclusion of this passage: “Intellectual property rights are an important incentive in the development of new health products.”
The World Health Organization’s Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property includes the same line, but adds, “This incentive alone does not meet the need for the development of new products to fight diseases where the potential paying market is small or uncertain.” The U.S. didn’t want that part in.
According to Médecins Sans Frontières, the U.S. refused to sign the draft declaration without its changes. The European Union, Norway, South Africa, Russia, and the Group of 77 coalition of developing nations all supported the original language; only the U.S. lodged an objection on paper. But in the end, the final draft released on July 20 included the U.S. version.
“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?” asked Sharonann Lynch with MSF’s Access Campaign in a damning statement.
After a four-day “silence procedure,” South Africa formally objected to the document, reopening negotiations. This sets new negotiations and a somewhat unclear way forward leading up to the high-level meeting in September. South Africa’s ambassador to the U.N., Jerry Matjila, did not answer questions from The Intercept.
If the resolution doesn’t reaffirm compulsory licensing, it sends a political message that countries opting for this legal procedure would face blowback from the world’s global superpower. While the TRIPS option would remain, poor countries wouldn’t have the backing of a global declaration to support their actions.
Health and Human Services spokesperson Ryan Murphy told The Intercept that the U.S. has been the global leader in funding the fight against TB, through research and subsidies for treatments to poorer countries. In a statement, Murphy said, “Experts and stakeholders know that what impedes TB patients from receiving treatments and care is not U.S. insistence on basic protections of intellectual property. Rather, it is the fundamental failure of healthcare systems to connect sick people with lifesaving treatments that are readily available and inexpensive.”
Médecins Sans Frontières didn’t think much of this argument. “There’s nothing stopping government from both taking actions to strengthen health systems and implement measures to promote access to medicines,” Palumbo said. “And when countries spend less on medicines, they have more resources for paid staff.”
But the White House’s line matches the pharmaceutical industry’s position on the issue. In a response to The Intercept, PhRMA spokesperson Megan Van Etten said, “The issues involved in the U.N. negotiations on tuberculosis are much more complex than any one press release has portrayed. Instead of tackling the real barriers to improved TB treatment – particularly the urgent need to strengthen and better fund health care systems – the negotiations risk getting stuck in an ideological trap focused on anti-IP arguments that aren’t relevant to the unique challenges of tuberculosis care.”
Not only does this mirror the White House’s position on TB, it’s nearly identical — as in word for word — to a private communication obtained by The Intercept from PhRMA’s lead representative at the U.N., Josh Black.
After the Trump inauguration, Black returned to the State Department and lasted about a year before resigning. Foreign Policy magazine reported that Black “had grown disillusioned serving an administration that was contemptuous of multilateral institutions.” Obama administration colleagues Samantha Power and Susan Rice praised Black on the way out, calling him a “national treasure” and a “pro’s pro.”
After Trump withdrew from the Iran deal, one of Black’s biggest diplomatic triumphs, he vented in a private Facebook message obtained by The Intercept, lamenting the White House’s “soul-crushing stream of boorishness, malevolence, and ignorance.” He added that “today’s decision … wasn’t just bad policy — it was DUMB policy, poorly executed.”
When Black left the State Department, he moved to PhRMA, becoming associate vice president for international advocacy. There is no direct link of Black to U.S. posturing over the TB declaration, but his entire job description is to “support U.S. pharmaceutical industry engagement with the United Nations” and “ensure that U.N. and other multilateral institutions understand the importance of protecting intellectual property.”
Representatives from the two major companies involved, Johnson & Johnson and Otsuka, both were present at civil society hearings on TB, and spoke on the floor. PhRMA’s role is a bit more obscure. “It’s fair to say they play a role in U.N. debates,” said MSF’s Palumbo. “But it’s more behind the scenes.”
Private communications show Black relating the precise argument of his employer on TB negotiations. He also cited an article from IP Progress, a pro-intellectual property coalition that includes PhRMA, in making his case.
That article makes the claim that most TB drugs are off-patent, although this isn’t accurate for newer, multidrug-resistant treatments from Johnson & Johnson and Otsuka. That talking point, however, wound up in the mouth of the spokesperson for the U.S. Mission to the U.N. at the TB hearing. “We would like to take this opportunity to point out that most existing treatment drugs for TB are off-patent and inexpensive,” she said, adding that the U.N. should focus on improving health systems rather than be “distracted” by compulsory licensing.
PhRMA did not make Black available for comment. An attempt to reach Black through his Facebook page was not returned.
The Obama administration went hand in hand with PhRMA on the issue of access to drugs in the developing world. PhRMA chastised India’s “anti-innovation intellectual property policies” at the same time that Obama sent John Kerry to the country to pressure them over their use of generic drugs that cut into industry profits.
Members of Congress have sought to prevent a replay in the Trump administration. A bipartisan group of senators have sent a series of letters to administration officials, imploring them to show leadership on the epidemic and close gaps in TB diagnosis and treatment around the world. One of those signatories, Sen. Sherrod Brown, D-Ohio, responded to the controversy over the draft declaration in a statement to The Intercept: “The global fight against TB makes us all safer, and the administration cannot put big pharma’s profits ahead of global health.”
But the Trump administration has consistently backed the drug industry’s efforts to squeeze more money from abroad. The president’s blueprint on lower drug prices is predicated on getting other countries to pay more, with the rather optimistic idea that the industry would subsequently lower prices in the U.S. And Health and Human Services Secretary Alex Azar, a former Eli Lilly executive, publicly criticized how other countries “command unfairly low prices for innovative drugs” at the World Health Assembly this May.
He reinforced this in Senate testimony in June, calling compulsory licensing a “socialist” process to “expropriate the product and get the product even cheaper.”
Putting big pharma’s profits ahead of global health is a bipartisan affair.