[CTC] Who killed the Covid-19 vaccine waiver?

[Arthur Stamoulis]

https://www.politico.com/news/2022/11/10/who-killed-the-covid-19-vaccine-waiver-00066137 <https://www.politico.com/news/2022/11/10/who-killed-the-covid-19-vaccine-waiver-00066137>

HEALTH CARE <https://www.politico.com/health-care>
Who killed the Covid-19 vaccine waiver?
The inside story of how lobbying, threats and the desire to protect industry gutted a proposal that was meant to make vaccines widely available in poorer countries.

BY ASHLEIGH FURLONG, SARAH ANNE AARUP, SAMUEL HORT

LONDON — “Is that a direct threat? I don’t know.” The adviser to the Belgian prime minister spoke calmly as they recounted a lobbying phone call from 2021, but the contents of the conversation are extraordinary.

The call was from a spokesperson for Janssen, the Belgian-founded pharmaceutical arm of Johnson & Johnson that developed the company’s single-shot Covid-19 vaccine. According to the adviser, the spokesperson warned them that if Belgium supported a radical proposal made by India and South Africa at the World Trade Organization, then Janssen might rethink its vast billion-dollar research and development investments in Belgium.

The proposal that provoked this fear, known as the TRIPS waiver, would have allowed some intellectual property rights for Covid-19 products to be waived during the pandemic. The ambition was to give companies wanting to produce vaccines and treatments the “complete freedom to operate,” explained one official from a country that co-sponsored the proposal.

But Big Pharma said a waiver would threaten investment and innovation — and rich nations, particularly EU members and the U.K., resisted it, arguing it would not bridge the huge gaps in vaccine availability between wealthy and poorer nations.

POLITICO and the Bureau of Investigative Journalism can reveal how this proposal was stymied and watered down by negotiators until it was finally signed off by governments desperate to save a flagging project. Through interviews with diplomats, officials, lobbyists and activists, as well as analysis of meetings and internal documents, we can reveal the key players behind the death of the waiver.

Big Pharma used its vast lobbying and influencing efforts to try to kill a proposal that threatened the very tenets of the industry. Top industry executives enjoyed direct access to senior officials within the EU, which was opposed to the proposal from the very start and encouraged potentially rogue member countries, including Italy and France, to fall into line. And the U.S., after a dramatic late intervention in favor of a waiver for vaccines, eight months after the proposal had been tabled, failed to follow through as the Biden administration came under pressure from industry and Congress, as reported by the Intercept.

When a compromise was finally reached, its value was questioned. The result — a small shift on one aspect of IP rights — was dismissed as “useless” by one Geneva-based diplomat, and far from the shining example of global solidarity that the WTO claimed.

Victor do Prado, who until earlier this year was one of the top officials at the WTO, said it was difficult to say whether a waiver would have boosted production, but calls the response to the proposal symptomatic of the “unilateral, nationalistic response” to Covid-19.

“This is a global problem. You need a global solution, and a global solution needs cooperation,” he said. “A waiver might have helped that cooperation.”

Winnie Byanyima, co-chair of the nonprofit People’s Vaccine Alliance and executive director of UNAIDS, the United Nations’ HIV program, said POLITICO and the Bureau’s findings were “extremely serious” and called for further investigation.

Take the call

Government advisers are no strangers to phone calls and emails from lobbyists. The Belgian adviser worked with the country’s prime minister, Alexander De Croo, and took multiple calls from Big Pharma representatives during the Covid-19 pandemic. They were eager to explain why they thought a waiver would affect their company’s investment in research and development. But the Janssen call stands out.

Like other large pharma companies, J&J opposed the waiver, warning publicly that opening up vaccine production to “inexperienced manufacturers” could undermine consumer safety.

Belgium, which is a European hub for the pharma industry, also already opposed the waiver. But Janssen appears to have been worried that the country’s stance might change, possibly after some Belgian politicians appeared receptive to the proposal.

Soon after Belgium’s development cooperation minister, Meryame Kitir, appeared on TV to support a lifting of vaccine IP protections in late April 2021, the adviser received a call from Janssen’s public affairs spokesperson.

“They said, ‘If Belgium is supporting this, the [J&J] headquarters in New Jersey are going to be agitated and they might consider reviewing the R&D [research and development] budget,’” the adviser told POLITICO and the Bureau. Janssen calls itself the largest private investor in R&D in the country, having invested €1.54 billion there in 2019.

Nine days after Kitir’s TV appearance, the Biden administration made a shock U-turn by announcing it would support a waiver that was limited to Covid-19 vaccines. The Belgian prime minister responded by calling a cabinet meeting, where he made it clear the country would not be following suit.

The adviser insisted that the call from the Janssen lobbyist did not change Belgium’s position and that such conversations were “what every lobbyist does.” Belgium believed a waiver may have boosted vaccine production by a small amount — no more than 10 percent — but that this was not worth disrupting the country’s pharma industry, including R&D at universities.

De Croo’s office said: “At no time did the Belgian government take any decision or was it forced to take a decision on the production of Covid-19 vaccines under pressure from the pharmaceutical industry, either related to patents or on any other aspect of this issue.”

J&J denied that such a conversation took place and said it does not represent the position of the company. However, it expressed concern about the growing use of compulsory licenses — where a government allows a company other than the patent holder to make a product — “particularly for the purpose of favoring domestic industries.”

“[Using compulsory licenses] threatens the overall IP system, which has enabled the development of lifesaving medicines for millions of patients today and has the potential to create new therapies for millions more in the future.”

The adviser characterized the spokesperson as “pretty low on the ladder” in J&J, and said they took the call with a “big pinch of salt.” “Is this spoken through with the headquarters in New Jersey? I don’t think so. Is it just like a cheap way to get their point across quickly? Yeah, probably.”

They eventually became so “sick and tired” of receiving lobbying calls from pharma companies about the waiver that they simply stopped picking up. “Every time they brought up the topic of IP again, I said, ‘Look, we’ve made up our minds. This was the position from the start. I don’t see any major thing changing this,’” the adviser said.

“The entire IP discussion dragged on for so long, that in the end, I always just ignored their calls.”

Apply some pressure

The above account echoes that of others around the world. An Indonesian official told POLITICO and the Bureau that, in 2020, when the country was in discussions with a different pharmaceutical company about a Covid-19 drug, the company pressured Indonesia on its waiver position. The “stick” was reduced investment, the official said.

This pressure delayed Indonesia’s decision to co-sponsor the waiver, they said. It did not do so until May 2021, after civil society groups and Indonesian pharmaceutical companies urged the government to back it.

Sometimes the industry did not even need to issue such threats. A number of officials from countries that received no direct pressure from pharmaceutical companies still said that their countries decided their positions on the waiver with Big Pharma in mind.

Colombian officials in Geneva, for instance, were told by their government to withhold support for the waiver to avoid disrupting vaccine negotiations with Pfizer and others, according to two people with knowledge of the negotiations.

When Covid-19 vaccines first arrived in late 2020, they were “like pure gold,” one said. But low- and middle-income countries such as Colombia had little leverage, meaning negotiations were one-sided. (In early 2021, the Bureau reported <https://www.thebureauinvestigates.com/stories/2021-02-23/held-to-ransom-pfizer-demands-governments-gamble-with-state-assets-to-secure-vaccine-deal?source=email> that some Latin American countries were being held to ransom by Pfizer, with the vaccine maker asking governments to put up sovereign assets as a guarantee against future legal cases.)

Because of these ongoing negotiations, one of the people said, Colombia withheld support for the waiver. “We didn’t want the noise of having the waiver when we were cutting [those deals].”

Colombia began distributing vaccines in February 2021. Civil society groups increased pressure on the government to support the waiver — and Biden’s U-turn in May upped the ante. Colombia officially began supporting the waiver in December 2021. “We realized that it didn’t make sense for us to continue having a very conservative approach,” they said.

A spokesperson for the Colombian government said it instructed its WTO representatives in Geneva to support developing countries’ position on the TRIPS waiver.

Mexico also had one eye on Big Pharma. It did not support the waiver because it believed that compulsory licensing and voluntary deals between pharmaceutical companies and third-party manufacturers would be a better fit. But it also knew that backing the waiver could hurt investment, a Mexican official told POLITICO and the Bureau.

“Mexico has good IP protection,” they said. “That really helps investment in the country … So that’s why we were ‘no’ [to the waiver].”

Protecting IP is a “good incentive” for the pharmaceutical industry to share its knowledge, the official said. “I think it’s a little bit of common sense. You’re not going to invest in a country if they cannot protect you,” they said.

Lobby talk

In the early months of the pandemic, possible shortages of Covid-19 products — protective equipment, potential treatments, and eventual vaccines — were a major concern for health officials across the world. In Brussels, European Commission officials — including Health Commissioner Stella Kyriakides and Internal Market Commissioner Thierry Breton — attended 12 meetings on the subject with the European Federation of Pharmaceutical Industries and Associations, a lobbying group.

But it was not until October that the radical proposal to waive aspects of the Agreement on Trade-Related Aspects of Intellectual Property Rights, was first put forward at the WTO in Switzerland by India and South Africa.

The pharmaceutical industry, however, was already moving to protect IP rights. Just days before TRIPS was tabled, the EFPIA met a member of the European Commission President’s cabinet to discuss the EU pharmaceutical strategy and the approach to IP in pharmaceuticals.

Then, four days after the proposal, the EFPIA met again with the Commission, this time with the competition commissioner’s cabinet member responsible for trade, Nele Eichhorn.

There are no minutes of these meetings, but pharma industry executives said publicly that the waiver would be disastrous for research and development. IP is the “blood of the private sector,” said Pfizer CEO Albert Bourla soon after the waiver proposal, according to Reuters <https://www.reuters.com/article/us-health-coronavirus-wto-idUSKBN28K2WL?source=email>. IP, he said, is “what brought a solution to this pandemic and it is not a barrier right now.”

The European Union was one of Big Pharma’s natural allies from the start. It is a stalwart of the modern IP system and, as such, a pharmaceutical powerhouse: Europe accounted for 24 percent of the world’s pharmaceutical sales in 2020.

As soon as the waiver was first proposed, the EU established its position. In October 2020 it said that a strong IP system was crucial to ensure the industry was “adequately incentivised and rewarded” for developing Covid-19 vaccines and treatments, and there was “no indication” that IP was a barrier to this process.

The industry had invested more than €39.6 billion into R&D in the region during 2020 and over the next two years it spent tens of millions more to lobby key EU officials on Covid-19, analysis shows.

Lobbying data shows how pharmaceutical companies, alongside major lobby groups that represent the industry, enjoyed extensive access to the most senior officials in Brussels and London, where U.K. politicians continued to oppose the waiver through the full 20 months of negotiations.

A government spokesperson told POLITICO and the Bureau that the U.K. wanted an outcome that addressed vaccine inequity “whilst not undermining the existing IP framework.”

Between January 2020 and September 2022, 13 pharmaceutical lobby groups and companies held nearly 100 meetings with the most senior Commission officials. In the U.K., there were more than 360 meetings between January 2020 and March 2022 — equivalent to nearly one every two days. Boris Johnson personally attended 11 of them.

While some of the meetings were directly related to the pandemic and vaccines, many were not. But the cumulative number of meetings is indicative of the frequent and close interaction that the industry had with senior officials.

Those are just the meetings where information is publicly available. U.K. ministers are obliged to publicly disclose official meetings with external organizations but more junior staff are not. In Brussels, informal communications such as impromptu phone calls do not need to be recorded on transparency registers.

Pharmaceutical companies could easily arrange calls and meetings with the most senior government officials. Industry figures such as Bourla had access to top politicians, as evidenced in the text messages that he exchanged with Ursula von der Leyen, the president of the European Commission, first reported by the New York Times <https://www.nytimes.com/2021/04/28/world/europe/european-union-pfizer-von-der-leyen-coronavirus-vaccine.html?source=email>.

The contents of the messages remain unknown. The European Ombudsman Emily O’Reilly said in July that the Commission’s response to a journalist’s request to see the texts amounted to “maladministration.” (In September, the European Court of Auditors accused the Commission of refusing to disclose any details of von der Leyen’s personal role in Pfizer’s vaccine negotiations.)

The Commission insists that texts are “short-lived and ephemeral” documents, which are not kept, and “in general do not contain important information relating to policies, activities and decisions of the Commission.”

A spokesperson for Pfizer said: “Pfizer has openly discussed our position with all stakeholders, explaining the negative impact that weakening intellectual property through mechanisms such as the TRIPS waiver would have on equitable access and patient care.

“We categorically deny any allegation that an individual country’s position in relation to the TRIPS waiver was in any way connected to vaccine contract negotiations with Pfizer. To suggest otherwise is inaccurate, misleading and irresponsible.”

Splash the cash

The industry spent millions lobbying the EU throughout the pandemic. In the EU during 2021, Covid-19 vaccine and treatment developers including Pfizer and Moderna and the largest pharma lobbying groups, including the EFPIA, spent at least €15 million on lobbying. The year before, the companies spent more than €15.7 million. In 2019, their lobbying costs were €13.9 million, according to data analyzed from LobbyFacts. Similar data is not available in the U.K.

Moreover, the major industry players also paid at least 31 private consultancies to lobby the Commission on their behalf. AstraZeneca and Johnson & Johnson each paid around €700,000 in 2021 for consultancies working on topics such as the EU vaccines policy and the bloc’s strategy for Covid-19.

Civil society groups who supported the waiver lobbied too, but had only a fraction of the firepower of their industry counterparts. An analysis of health-related lobbying by the 105 organizations that support the People’s Vaccine Alliance, alongside Doctors Without Borders, shows about 60 meetings with senior Commission officials, roughly two-thirds as many as the pharmaceutical industry. In the U.K., there were 20 meetings.

A spokesperson for the charity STOPAIDS said it took “weeks and months” for the U.K. government to respond to emails to arrange an “occasional short meeting.” Speaking about a recent “one-sided” meeting about Covid-19 treatments it added: “It is hard not to conclude the government’s engagement with civil society organisations, in their approach to TRIPS waiver negotiations, was simply tokenistic.”

In at least one case, Geneva-based officials were in close contact with a vaccine developer to ensure that whatever was agreed at the WTO would not negatively affect production.

“We were also genuinely talking to the Oxford academics who were designing the thing and actually asking them the question of, ‘How would [the waiver] impact you?’” said a Geneva-based diplomat close to the negotiations.

Hyo Yoon Kang, a reader in law at the University of Kent, said: “It seems that the Commission paid a very expensive ransom of maximalist IP rights in favor of few pharmaceutical corporations, which came at the expense of global and European public interest at the height of a global pandemic.”

“This sets a politically undesirable precedent for future pandemic preparedness, because we will face the same IP barriers to equitable access to health technologies again.”

Because the recorded summaries of the meetings are often vague, it is impossible to tell precisely how many meetings between the pharmaceutical industry and top EU officials included discussion of the waiver. One, for example, was “pharma strategy,” while another was about “vaccines.” But some meetings occurred at key points on the negotiation timeline.

The EU told POLITICO and the Bureau: “The EU has been at the forefront of the work on the WTO response to the Covid-19 pandemic. Since the start of the pandemic, the President has repeatedly stated that fair access to vaccines and equitable production of vaccines is crucial to fight the pandemic, especially in regions such as Africa that depend on imports of pharmaceutical products.”

They added it believes the protection of IP is “part of the solution” for Covid-19 vaccines because it incentivizes innovation and investment, including in developing countries.

Lost for words

In May 2021, the U.S., which opposed a waiver in early meetings, reversed its position, to the shock of many WTO delegates. It took just two days for the U.K.’s pharmaceutical lobby groups, alongside Pfizer and MSD, to meet with the U.K. trade policy minister Greg Hands, vaccines minister Nadhim Zahawi and International Trade Secretary Liz Truss.

In Brussels, 12 days after the U.S.’s reversal, EFPIA met three members of the cabinet of the EU commissioner for trade, Valdis Dombrovskis, to discuss the bloc’s vaccine policy. The following month, Doctors Without Borders, Health Action International and Human Rights Watch met two members of Dombrovskis’ cabinet to discuss trade in relation to Covid-19 products.

In late October 2021, as the date for a proposed key WTO ministerial conference approached, Pfizer, Sanofi and the EFPIA met members of Dombrovskis’ cabinet to discuss trade-related issues. Earlier in the month, Doctors Without Borders, Health Action International and Human Rights Watch had also met a member of his cabinet.

At the end of November, just four days before the scheduled conference where the TRIPS waiver was to be a key point of discussion, von der Leyen met the CEOs of Moderna and Pfizer. Doctors Without Borders would also meet with Dombrovskis himself that month to discuss global access to Covid-19 vaccines and drugs.

The conference was eventually postponed, and the debate over the waiver continued into 2022. It was at this point that the EU, the U.S., India and South Africa came together for small-group discussions on the waiver, known as the “Quad,” in an attempt to break the deadlock. The pharma lobbying continued.

A senior industry lobbyist told POLITICO and the Bureau that they had “some engagement with senior level” officials in the U.S., “who indicated that their interest was to protect U.S. interests.” But when it became clear that their message was not affecting the U.S. position, they looked to Europe, including the U.K., which they saw as more receptive.

On March 5, 2022, when Quad discussions were continuing in earnest, the U.S. Chamber of Commerce met the Commission, according to documents obtained by POLITICO and the Bureau through freedom of information requests. At the meeting were the U.S. pharma lobby groups PhRMA and BIO as well as Pfizer, Eli Lilly and MSD. According to the meeting details, the Americans “presented their general concerns with the waiver proposal” as endangering research and innovation.

And in the U.K., two days after a position document from the Quad leaked and was reported by POLITICO in mid-March, Britain’s biotech lobby met George Freeman, a science minister, “to discuss intellectual property and the life sciences sector.”

The month before the June ministerial at which the final outcome was decided, Doctors Without Borders met a member of Dombrovskis’ team to discuss the waiver. But the access enjoyed by civil society groups was well outstripped by industry figures.

Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations, told POLITICO and the Bureau that it was legitimate for the pharmaceutical industry to “contribute to policy discussions” because it was “one of the critical players in the response to the pandemic.”

He said the federation “provided examples of concrete challenges” that companies were facing, creating awareness of roadblocks and urging decision-makers to address them.”

The People’s Vaccine Alliance, a coalition of more than 100 organizations that campaign for free universal access to Covid-19 vaccines and treatments, said: “The views of health experts, trade experts, charities, unions, scientists, health workers, UN agencies, and even the European Parliament were dismissed in favour of the wealthy pharmaceutical lobby. Put simply, money talks.”

Bending the Commission’s ear

After everything, the lobbying may have been unnecessary. Throughout the negotiations, the Commission remained steadfastly opposed to a broad IP rights waiver as proposed by South Africa and India. The EU maintained that IP was not a barrier to vaccine access, and, even if it were, existing mechanisms such as compulsory licensing could be used to overcome any obstacle to production.

But in private meetings, it became clear that this opposition was not just about the Covid-19 pandemic or whether a waiver would boost production. It was partly about protecting the future of the IP system.

At the Council of the EU’s trade policy committee <https://www.consilium.europa.eu/en/council-eu/preparatory-bodies/trade-policy-committee/?source=email>, in November 2021, the Commission warned that if officials accepted “the protection of intellectual property as a problem, one will soon be confronted with similar demands for other products,” according to documents seen by POLITICO and the Bureau.

In another meeting the same month, Germany demanded “unanimous support” for the EU’s position, which was important “to counteract the risk of future relaxations in the TRIPS area or even the loss of IP rights.”

“They didn’t want to open [Pandora’s box],” a Geneva-based diplomat, whose country is one of Europe’s pharmaceutical hubs, told POLITICO and the Bureau. “Don’t set the precedents on it because once you start acknowledging the IP, there will be more health crises, there will be more diseases.”

Contrary to the united front presented at the WTO, divisions were emerging among EU member countries about the waiver position. In late 2021, Austria, the Netherlands and Belgium repeatedly pushed for the EU to keep an open mind to softening international IP rules.

This echoed public splits among EU members. Emmanuel Macron came out in support of the waiver in 2021, and Italy’s left-leaning health minister, Roberto Speranza, called the U.S.’s support for free access to patents on vaccines an “important step forward.” Italian Prime Minister Mario Draghi also said his country was open to the idea.

Both nations eventually backtracked: Speranza realized quickly that IP was not hindering the production of vaccines, according to a member of his entourage, and by January 2022, Macron fell into line with the EU. He told European lawmakers that France had been in favor of the proposal but that it was “easy for France to be in favor because we don’t have any patents … because it wasn’t French pharmaceutical companies that found the vaccines.” He rejected the idea of ripping up patents through a waiver and instead proposed a “global license” for Covid-19 vaccines to increase access.

Germany was a huge driving force behind the EU’s stance — its total opposition to a waiver was consistently backed by countries including Ireland, Sweden and Denmark at the trade policy committee <https://www.consilium.europa.eu/en/council-eu/preparatory-bodies/trade-policy-committee/?source=email>. These three countries also house significant pharmaceutical industries: Ireland is the largest net exporter <https://www.ipha.ie/about-us/contribution-to-the-irish-economy/?source=email> in the EU of pharmaceutical products; they make up Sweden’s second-largest <https://www.lif.se/en/our-industry/?source=email> export category in value; and almost a fifth <https://www.lif.dk/fakta-analyse/life-science-i-tal/?source=email> of Denmark’s total goods exports, according to industry bodies.

At the WTO, Germany worked closely on the waiver with the U.K. and Switzerland, but also with the U.S., according to two Geneva-based diplomats.

The German government has always held the view that IP is crucial for driving innovation in the national economy, a German official told POLITICO and the Bureau. Where BioNTech had helped Germany get a handle on the pandemic and helped supply the world, other countries had no vaccine on the market. “Maybe that made it easier for [others] to show political flexibility,” the official said, which suggests Germany’s position was partly influenced by the success of BioNTech.

A spokesperson for the German government confirmed it “held discussions with non-governmental organisations, industry associations and affected companies, including BioNTech.” They added that “industry associations cited the importance of protecting intellectual property rights.”

Koen Berden, executive director for international affairs at the EFPIA, told POLITICO and the Bureau that EU member countries who benefit economically from a large pharmaceutical industry — such as Germany, Belgium, Italy, France and Denmark — were “very keen” to understand the potential impact of the waiver.

He added that around half of the meetings the EFPIA had with the Commission between January 2020 and July 2022 were “unrelated to Covid-19 and focussed on other areas of EU medicines policy, and often held at the request of the European Commission or Parliament.”

The Geneva-based diplomat said: “We have big pharmaceutical industries … and it is very difficult to give in on [intellectual property] because it’s at the core of their business model.”

The diplomat criticized the Commission’s initial hard-line response to the waiver proposal as being too technical. “There was a lack of political leadership … There’s a health emergency, there’s a question of solidarity and political signaling towards the developing world and Africa in particular.”

The Commission and its member countries were, eventually, worried about how it would look to oppose a waiver while millions died of Covid-19. Germany encouraged “smart communication on the topic” that “underlines the proactive role of the EU in providing vaccines globally.”

When countries including Belgium, Finland and Spain expressed worry that the EU could be seen in the “wrong light,” the Commission promised to schedule media work and prepare a briefing document for member countries, adding that it was “important that these are then taken up and used by politicians.”

Combined with the U-turns of Macron and Speranza, this suggests that the Commission managed to rein in potential rogue countries and align member countries behind a single position against the waiver, all the while feeding politicians talking points for press conferences.

But because Brussels was so intent on showing that the ailing WTO could deliver results, it became one of the driving forces behind the Quad discussions. Brussels’ initiative to try to break the deadlock came much to the U.S.’s surprise, according to an EU source. The U.S. did not expect the EU to budge from its fully anti-waiver stance, which suddenly exposed its own lack of a clear line.

Ngozi Okonjo-Iweala, the WTO director general, was also instrumental in establishing the Quad discussions. The WTO saw a failure to agree a deal on TRIPS, as well as on other trade-related issues, as potentially ruinous to its international reputation. Okonjo-Iweala warned in June 2022 that failure to agree on TRIPS and other trade issues would mean “substantial” costs for individual countries.

“I think it would have been … the demise of the WTO,” a Geneva-based trade official told POLITICO and the Bureau.

Uncle Sam’s big day

By May 2021, the talks had reached a stalemate. South Africa, India and the 62 co-sponsors of the waiver — including the 44 countries in the African Group — still wanted a broad waiver. The EU, U.K., Switzerland and others were still standing firm.

The U.S. decision to announce its support for a waiver that was limited to vaccines — i.e. one that excluded Covid-19 treatments — could have been the moment everything changed.

The announcement by Katherine Tai, the U.S. trade representative, on May 5, 2021, made clear that the U.S. “believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines.” Tai said the U.S. would “actively participate in text-based negotiations” at the WTO to ensure IP protections for vaccines were waived.

She doubled down in November, writing in a letter to senators that “the decision to support a waiver of IP protections for Covid-19 vaccines reflects the extraordinary circumstances of this pandemic.”

None of the dozens of people POLITICO and the Bureau spoke to expected this stance from a country that was once a driving force <https://digitalcommons.wcl.american.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1467&context=auilr&source=email> behind the creation of international IP rights. As a result, WTO delegates clamored to reassess their own positions. Eventually, heartened by the U.S.’s position, countries like Colombia backed the waiver — and Australia cited the U.S.’s change of heart when it came out in support of a waiver in September 2021.

Some said it felt like a waiver was now genuinely possible, given the influence of the U.S. at the WTO. “We were really in shock when they supported the waiver,” said an official from one country who opposed the waiver. “Once you have the U.S. support, it gives you a lot of strength … it got momentum.”

But in the months that followed Tai’s announcement, the U.S. failed to back up its public rhetoric. For more than a year after the announcement, U.S. officials in Geneva said almost nothing new at the TRIPS Council. “What we experienced was that the U.S. was very, very disengaged,” one official involved in negotiations told POLITICO and the Bureau. “They would repeat the same statements … for months.”

Despite the U.S. supporting a waiver, and pledging to be “active” in negotiations, it did not put forward a concrete proposal. This is in contrast to the EU, which in June 2021, a month after Tai’s announcement, proposed an alternative to the waiver that focused on changing rules around compulsory licenses.

The question on observers’ minds was why the U.S., if it genuinely wanted a waiver, didn’t propose its own solution. A U.S. trade official told POLITICO and the Bureau there were “already sufficient things on the table” to discuss.

The other factor, they said, was “stakeholders that were in very different places on the issue,” which made it difficult to create a proposal text. “You’ve got the pharmaceutical companies on one end, obviously not wanting it, you’ve got the NGO community, different folks pushing for different things. And we have all sorts of people in between.”

One of those “sorts of people” were Republican Congress members, who were demanding <https://buchanan.house.gov/media-center/press-releases/buchanan-carter-lead-letter-calling-biden-protect-us-intellectual?source=email>Biden abandon his support.

The official said the U.S.’s motivation for publicly supporting a waiver was first to “promote and facilitate vaccine production,” and second to “facilitate a conversation” on the waiver. In contrast to other officials POLITICO and the Bureau spoke to, they characterized the final outcome as both a “waiver” and a “middle ground” between supporters and opponents of the initial proposal.

As for what exactly the U.S. had envisaged when it announced its support for a waiver, the official was vague. “What we wanted first was to be able to have a conversation that was based on fact, and what is it that is actually needed in order to promote and facilitate vaccine production in the areas where you don’t currently have it,” they said.

The EU was watching the U.S. with trepidation. At a trade policy committee meeting in November, the U.S. position was considered the “greatest risk” for the EU, while at another meeting the same month, the Commission said there was “great danger” the U.S. would announce its position at a key conference in the coming weeks, and that the U.S. might push for “a complete waiver for vaccines”

In another discussion, Italy asked about a “tactical approach” if the U.S. presented a proposal for a limited waiver.

The EU believed it could have been forced to accept a waiver if it came under enough pressure. “The worst conceivable scenario is that the EU becomes isolated and is under pressure to accept an unacceptable outcome,” it said at one committee meeting, referring to the waiver among other things.

Waive goodbye

What was the outcome of the months of meetings and conversations? Nothing like what South Africa and India proposed for the waiver originally, but much closer to the EU’s own counter-proposal in 2021. It clarifies some of the existing flexibilities in TRIPS and allows countries more freedom to export Covid-19 vaccines that are made under a compulsory license.

It is best described as a “narrow and temporary exception to an export restriction, not a waiver,” James Love, director of Knowledge Ecology International and an adviser to both UN agencies and governments, wrote in June. He added that the decision would only be useful if a developing country went through the long process of issuing a compulsory license, getting regulatory approval for a vaccine, making it, then exporting it.

A WTO spokesperson said that the outcome had been welcomed by many countries, including India and South Africa, which was “testament to the broad support the decision has received and recognition that it will play an important role in contributing to vaccine equity and availability.”

Back in Geneva, delegates have until December to decide whether to extend the limited negotiated agreement to treatments and diagnostics — and it could be another dog fight. The implications of expanding the waiver are potentially massive, given that drugs are generally easier to make than vaccines.

It is against that backdrop that an official at the European Commission’s trade department emailed Pfizer on July 7, seeking more information on the “COVID therapeutics side from the industry.”

“The discussions on this issue are already kicking off in Geneva, so it would be really useful to start with some basic facts here,” the official wrote in an email that was obtained by POLITICO and the Bureau through a freedom of information request.

The Pfizer staffer replied, saying the EFPIA was putting this material together. In September the data was released, setting out the nightmare that the industry saw looming. The industry’s analysis showed that 135,627 drugs and test patents would be directly impacted. A three-year waiver would also lead to a 25 percent drop in research and development in high-income countries, the lobby group claimed.

The U.S., which backed a waiver only for Covid-19 vaccines, had not yet decided its position on treatments and therapeutics when POLITICO and the Bureau interviewed the senior trade official. Last year, their support was restricted to vaccines, because “at that time … the key is to get shots in arms, and it’s to facilitate the production of vaccines.”

Already there is concern that the delays that plagued the original discussions will be repeated. A Geneva-based official from a lower middle-income country that supported the waiver predicted there would be no decision this year because of how strongly some countries, particularly the U.K. and Switzerland, will oppose IP flexibility on Covid-19 treatments. Switzerland told POLITICO and the Bureau that it “does not consider that intellectual property is a barrier to accessing Covid-19 diagnostics and therapeutics.”

Another Geneva-based trade diplomat said that the U.S. and Germany “will clearly nip it in the bud … they won’t budge.”

The 20 months of battering negotiations have implications for health emergencies beyond Covid-19. “Clearly, there is a problem within the system,” said Luke McDonagh, assistant professor of law at the London School of Economics. “The TRIPS Agreement is really serving the interests of the high-income countries, and it’s doing virtually nothing for the lower middle-income countries,” he said, adding that he was hopeful the WTO recognizes the need to redress that balance.

Even the Belgian adviser acknowledged that “there’s a conversation to be had” about the role of IP. “We just have to sit around the table when things calm down and then discuss, okay, what went good? What went wrong?”

Proponents of the waiver are not going away. The official from the lower middle-income country called for the political will to “question the system” and ensure developing countries were better prepared for future emergencies. “The rules of the IP are very important, we respect that, we believe in that. But we also want to call to attention the actual problems, the inequalities, and the gap that we have, and how the system can really help.”

Another official, from a Latin American country, said the TRIPS waiver negotiation created a bigger discussion about the role of IP in health emergencies, and that the limited agreement secured at the WTO can be used as a starting point for future debates.

“I hope I don’t live in another pandemic,” they said. “But if I [do] and am young enough to negotiate, at that moment, I can say, for COVID we did this. It took us too long. It came too late. But we have this already,” they said.

Byanyima, the UNAIDS executive director, told POLITICO and the Bureau that she would continue pushing for reform of IP rules and that the TRIPS negotiations had convinced many rich countries to “accept that intellectual property was a barrier” to access.

“This has not been our proudest moment, but we did make some headway,” she said.

As the discussion continues around treatments and tests, she says that governments should “stand up and do their role, which is to break their monopoly and allow the sharing of technology, intellectual property and knowledge so that there’s more production — not just [of] vaccines but of treatments and diagnostics all over the world.”

“COVID was the real moment for that change. It hasn’t come. But I can tell you we will win this sooner than later.”

Leonie Kijewski, Carlo Martuscelli and Misbah Khan contributed reporting.




Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826




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