Biden’s got pharma’s back in global pandemic treaty negotiations

The Biden administration and the pharmaceutical industry are battling over drug prices in Washington and courthouses around the country.

But in the international arena, they’re united in an effort to block developing countries from access to U.S. firms’ patented information on vaccines and drugs when the next pandemic hits.

U.S. negotiators working on a global treaty that aims to guide the world’s response whenever a new deadly pathogen emerges have rejected proposals to loosen patent protections, a step that could enable developing countries to quickly make their own versions of the vaccines and drugs.

For those countries and their advocates, it’s a striking stance — given what happened after Covid arrived: They shared data about new variants only to see the rich world hoard most of the vaccines.

“There’s a contradiction, [an] enormous amount of hypocrisy,” said James Love, director of Knowledge Ecology International, who advocates for wider access to health products, of the Biden administration’s position.

Love said the U.S. has used some of the same measures developing countries have proposed to limit intellectual property rights in the production of Covid vaccines at home.

Asked about the Biden administration’s stance, a spokesperson for the Department of Health and Human Services said it was seeking a balance.

“The U.S. wants outcomes that are effective and operationally viable to protect national and global health, promote innovation and promote access to medical countermeasures, strengthen investments in global health security, secure additional governmental commitments and responsibility for pandemic prevention and response, that are consistent with U.S. laws, policies and practices,” the spokesperson said.

The State Department declined a request to interview the chief U.S. negotiator, Pamela Hamamoto, who has said that strong intellectual property rights enabled the quick development of vaccines and therapeutics that saved millions of lives during the pandemic.

The U.S. position in the treaty negotiations — in contrast to Biden’s aggressive push to force drugmakers to lower their prices in the U.S. via pending Medicare price negotiations — shows there are limits to the president’s willingness to upend the patent system.

Unlike Medicare price negotiations, pharma views the erosion of intellectual property rights as an existential threat to its business model, said Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University. He has advised the White House and the World Health Organization, the U.N. body that convened the pandemic treaty negotiations.

“The Biden administration is willing to push the envelope, but they’re not willing to break the business model,” Gostin said.

Negotiators for developing countries say they’re not looking for more charity, just equitable access to drugs and vaccines in future pandemics.

WHO Director-General Tedros Adhanom Ghebreyesus warned this month that nations’ unwillingness to compromise means they might miss the May deadline to finalize the treaty.

“We will have missed our chance to make history,” Tedros said at a meeting with member countries. This would be a “missed opportunity for which future generations may not forgive us,” he added.

Back to the status quo

During the worst of the Covid pandemic, under pressure from the progressive wing of his party, the Biden administration reversed longstanding U.S. policy opposing waivers of patent protections.

In May 2021, as developing countries watched rich nations vaccinate their citizens while they waited for shots, U.S. Trade Representative Katherine Tai announced America’s support for a proposal from South Africa and India that would waive those protections for Covid vaccines as part of World Trade Organization talks.

The administration supported the waiver because of the gravity of the situation at the time in an effort to end the pandemic, the HHS spokesperson said.

But when WTO member countries agreed finally in June 2022 to issue the waiver, theoretically permitting developing countries to make their own Covid vaccines using U.S. drugmakers’ formulas, it came too late.

Pharmaceutical companies in Western countries and India were pumping out millions of doses but demand for shots had waned globally, as people saw the risk of severe disease diminishing.

Talks about extending the waiver to include Covid tests and treatments continue at the WTO but face bipartisan opposition in Congress.

The WTO process revealed a deep split within the Democratic Party, with progressives supportive of broad waivers of U.S. intellectual property rights, and moderate Democrats strongly opposed. Republicans also opposed the waivers.

More than a dozen senators from both parties, including Chris Coons (D-Del.) and Mike Crapo (R-Idaho), wrote to Biden and Tai this month asking them to reject the waiver of patent protections for tests and treatments because, they said, it wouldn’t improve global access to Covid drugs while negatively impacting “American manufacturers, innovation, and global competitiveness.”

Nearly 20 House Democrats signed a similar letter in December.

Pharma representatives said that forcing them to share their formulas wouldn’t lead to much manufacturing in the developing world because companies seeking to produce vaccines and drugs need knowledge and expertise that don’t come with patents.

“This doesn’t work if it’s coerced,” said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations, of the patent waivers.

And the Biden administration, despite its willingness to loosen patent protections during the worst days of Covid, has taken pharma’s side in the treaty negotiations that could guide the world’s response to the next pandemic. Some European nations, including Germany, have also sided with their drugmakers.

The top U.S. negotiator for the pandemic treaty, Hamamoto, argued in a meeting in Geneva in November that requiring more access to U.S. drugmakers’ inventions would undermine the very system that worked in response to Covid without improving access during future pandemics.

“The United States believes strongly in IP protections, which serve to fuel investment and innovations,” she said, adding that the U.S. is also “exploring options” to make tests, drugs and vaccines more readily available for developing countries during future pandemics.

Jim Risch, the Senate Foreign Relations Committee’s top Republican, who would exercise influence if a treaty ever makes it to the Senate for ratification, said he couldn’t support a deal that threatens intellectual property rights.

The Idaho senator agrees the U.S. needs to help others access vaccines, but he said “giving away IP protections will kill innovation.”

An impasse in Geneva

Biden’s willingness to grant vaccine waivers at the WTO reflected the recognition during the Covid pandemic’s darkest days that contagious diseases don’t respect national borders.

The rapid spread and deadly path of Covid’s Delta variant, first detected in India in the fall of 2020, also suggested that no country could expect to be protected from Covid while other parts of the world remained unvaccinated.

Biden’s reversal on pandemic waivers in the current treaty negotiations indicates those lessons weren’t fully absorbed, argue advocates for developing countries.

The U.S. wants “all the sharing of technology, or removing IP barriers or financing, to be on voluntary basis and mutual agreement, which means leaving the world to be under the will of pharmaceutical companies and rich countries,” said Mohga Kamal-Yanni, senior global health policy adviser at the People’s Vaccine Alliance, a coalition of more than 100 organizations that advocates for unfettered access to shots.

Representatives of developing countries have made similar points during the talks.

“For the future, why would we be hesitating [and] have no workable measures” given the Covid experience, wondered Mohammad Kamruzzaman, a Bangladeshi diplomat.

Bangladesh is part of a group of 29 countries from Africa, Asia and Latin America promoting the developing world’s position in the negotiations.

They argue that they should be compensated for providing pathogen data that drugmakers use to develop vaccines and drugs.

“What we don't want is that we agree right now to very strict obligations in terms of prevention and surveillance, and then all that we want — the benefit-sharing, the flexibilities in intellectual property, the funding — all that remains open to be discussed in the future,” said one diplomat from a middle-income country granted anonymity to speak candidly.

But the U.S. and the pharma industry are staunchly opposed.

“The countries sharing the viruses, the pathogens, are not doing us a favor,” Cueni of the International Federation of Pharmaceutical Manufacturers & Associations, said. He explained that all countries have a keen interest in the development of treatments that combat disease.

A middle way?

The May deadline for completion of the pandemic treaty is fast approaching and advocates of a deal hope the Biden administration’s hard line will give way to compromise.

But what compromise would look like is unclear.

“I am convinced that the Biden administration understands very clearly the need for equity and they understand they're not going to get scientific sharing unless they make meaningful concessions,” said Georgetown University’s Gostin.

Love of Knowledge Ecology International said the stumbling block is the high cost of research and development of medical products.

“What will make for a more sustainable, ratifiable, acceptable agreement,” he said, is the development of a mechanism for “sharing the costs so you can have a more equal distribution of benefits.”

HHS has asked for public input on some of the issues at stake.

Meanwhile, progressives, whom Biden needs on his side to win reelection this November, continue to pressure the administration.

“We are working with the administration and their representatives to the World Health Organization to make sure that they stand up to the drug companies, and that they make sure, in a variety of ways, that [through] the production of generic drugs, information sharing, etc., that all people on this planet are able to get what they need in terms of vaccines,” said Sen. Bernie Sanders, the Vermont independent who’s the faction’s champion.

The next treaty negotiations are scheduled for Feb. 19 and a spokesperson for the White House’s National Security Council suggested in an email that the Biden position could yet evolve.

“One of the United States’ core goals in these negotiations is to support more equitable access to, and delivery of, vaccines, tests, treatments and other mitigation measures,” the spokesperson said. “Negotiations of the Pandemic Accord are ongoing, and no Member States have agreed to any final positions.”

Adam Cancryn contributed to this report.