In May, the Biden administration made a bombshell declaration, endorsing a call to temporarily suspend intellectual property (IP) rights on COVID vaccines that health and trade experts say could greatly improve access to shots in the Global South — a move that appeared to mark a turning point in the global fight against the pandemic.
Months later, though, as the pandemic rages and the glaring gap in vaccine access grows, the effort remains blocked at the World Trade Organization (WTO). Any waiver for vaccines needs the green light from the organization’s TRIPS Council — the commission in charge of IP rights — and unanimous support from all 164 members. But as delegations return to Geneva after summer break, a long-circulated proposal backed by India and South Africa has yet to gain traction.
“It’s really upsetting watching this process,” says Hu Yuan Qiong, policy co-coordinator and senior legal and policy adviser for Doctors Without Borders’ Access Campaign. “Viruses disregard whatever game we’re playing in human society; they just carry on and mutate.”
The deadlock is the product of multiple factors. Hostility from the United Kingdom and the European Union as well as criticism from Big Pharma have complicated efforts, but as experts tell us, so has the apparent unwillingness of the Biden administration to go beyond its four-month-old statement and actually start pressing for a waiver.
“I’ve been working on trade policy for a while, and I know that when the United States wants something, they get it,” Burcu Kilic, a trade policy expert at Public Citizen, tells us. “The United States should [play] a proactive role in this discussion.”
European Intransigence Amid Pharma’s Lobbying Blitz
One immediate obstacle is the United Kingdom. As Hu from Doctors Without Borders says, Prime Minister Boris Johnson’s government has shown little interest in changing its position over the last few months. She says it’s effectively stuck to the talking points of AstraZeneca, pointing to the pharmaceutical company’s willingness to work with producers in the developing world as supposed evidence that a waiver is unnecessary.
Appearing before the TRIPS Council in June, for instance, the British government argued that technology transfers and voluntary licensing “exemplified by the Oxford AstraZeneca vaccine” and its partnerships are “making real, positive impact.” In a statement, the UK said it was not “convinced how an IP waiver, if agreed, would increase the supply of COVID-19 goods.”
Hu doesn’t buy it. “We’ve explained to them, ‘We’re not just talking about AstraZeneca vaccines, we’re talking about many vaccines and many treatments,’” she says of the UK. “Maybe a company like AstraZeneca has done a little bit more than another company, but that will not solve the global issue.”
An ideal waiver on IP rights, she stresses, would also cover the two messenger RNA (mRNA) vaccines developed by Pfizer and Moderna, as well as medical equipment, technologies used for therapeutic treatment, and future vaccines.
Lobbying disclosure regulations in the UK are relatively weak. Only lobbyists working for third-party firms are required to sign the country’s lobbying register, which, as a result, covers just a small fraction of the country’s lobbyists, most of whom are employed in-house.
Still, British government departments are required to disclose information about meetings with external organizations — and, according to records compiled by Transparency International and consulted by us, no single external organization in the UK has met more with the British government since the beginning of 2021 than AstraZeneca. The Cambridge-based pharmaceutical giant beat out the country’s top business lobby, the Confederation of British Industry, and the Port of Dover, the massive seaport that has struggled to adjust to Brexit.
In the meantime, the European Union also continues to oppose a proposed TRIPS waiver. While several national governments — including France and Spain — have said they support a waiver, what ultimately counts in Geneva is the stance of the EU’s executive branch, the European Commission. Rather than open up talks over the text backed by South Africa and India, the EU has offered up a separate proposal of its own, bogging down the discussion.
EU officials maintain that a broad waiver on IP rights for vaccines doesn’t address the underlying problem of inadequate manufacturing capacity. According to this argument, even if producers in lower-income countries had the legal authority to start churning out COVID vaccines, they wouldn’t be able to, because they lack the factories or technological know-how.
But Hu of Doctors Without Borders says that’s a red herring. Like many supporters of a temporary suspension in IP rights, she doesn’t claim a waiver will result in a transformation overnight. Instead, she views it as a launching pad to a scenario in which knowledge, data, and technology can flow more freely between states and manufacturers.
“We can’t say, ‘Okay, you have a law,’ and then tomorrow start [producing]’ — it’s not going to happen that fast,” she explains. “But the earlier you open the door, the more certainty you can provide for the producers so they can prepare . . . the longer they don’t allow this door to open, the more problems we’ll face.”
As we have previously reported, Big Pharma boasts a heavy presence in Brussels. Between March 2020 and May 2021, EU commissioners involved in medicine and vaccine issues met 140 times with pharmaceutical companies, and just once with an organization that supports a waiver on IP rights, according to the Corporate Europe Observatory, a watchdog group. Last year, Europe’s top pharmaceutical lobby spent more than €5.25 million on lobbying EU officials, the eighth-highest amount reported by any lobbying organization in the EU in 2020.
For Hu, Big Pharma’s political influence helps explain the hostility from both London and Brussels to a waiver. “We strongly believe there is a direct correlation,” she says.
Closely related political and ideological factors help drive pushback as well — especially when it comes to Europe’s largest economy and most prominent opponent of a waiver, Germany.
The country is home to BioNTech, which developed the widely used mRNA shot alongside Pfizer. Even though the latter company has reaped most of the vaccine’s financial rewards, Burcu Kilic of Public Citizen says that officials in Berlin seem to regard vaccine development as a source of national pride. For many within Chancellor Angela Merkel’s ruling party, the Christian Democratic Union, there is a sense that lifting IP protections amounts to a slap in the face to national industry.
“It goes beyond BioNTech,” Kilic says. “It’s about German inventions, German [small and midsize enterprises], Germany saving the world . . . it’s political, but it’s also emotional.”
Both Hu and Kilic argue the United States should be more aggressive — by putting pressure on its allies to back a waiver or, at the very least, by jump-starting serious negotiations.
Up until now, the Biden administration has largely kept to the sidelines on the issue of IP rights. However, the US government may already have a strong case that it owns the IP on the Moderna vaccine, given its role in the shot’s development. The Biden administration could, in theory, share information about the dose with other producers — as the South Korean government has already requested.
But even beyond the narrow issue of the Moderna shot, the American agency that negotiates trade policy, the United States Trade Representative (USTR), hasn’t issued a statement on the subject of a vaccine waiver since its widely celebrated declaration of support back in May.
“That’s not usually what the United States or USTR does in these types of negotiations,” says Kilic from Public Citizen. “It’s like Lionel Messi saying, ‘I want to be in the World Cup,’ but then he’s not playing. You say you want a waiver, but you don’t do anything about it.”
The USTR did not respond to a request for comment.
In any case, the WTO’s TRIPS Council is slated to meet informally next week, on September 14. After weeks of inaction, that meeting could prove the impetus for progress, even if a full breakthrough doesn’t come until later in the year.
Kilic remains optimistic that the deadlock will break. For one, she says political pressure is mounting on the United States, EU, and UK. But she also argues the future of the WTO is at stake — a fact that helps explain why the organization’s newly appointed director-general Ngozi Okonjo-Iweala has taken an active role in talks.
“In the last decade, the WTO became a nonfunctional organization, and there’s pressure on the WTO and the WTO leadership to do something about that,” Kilic says. “[The director-general] knows that if they let this go, this’ll be the end of the WTO.”
That doesn’t necessarily mean the result will be to the liking of those pushing for a broad waiver. Unlike India and South Africa, for instance, the United States has called for a waiver that covers vaccines alone — not medical equipment or other COVID-related treatments.
Kilic also expects Big Pharma to start flexing its muscles in the coming weeks. If a deal at the WTO appears inevitable, industry will want to shape that outcome in its favor. She says much of the final outcome may depend on the Biden administration.
“We need them to take the lead,” Kilic says of the United States. “I believe there will be something, but the question is, what will it be?”