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Who killed the COVID vaccine


waiver?
Ashleigh Furlong, Sarah Anne Aarup, Samuel Horti

37–47 minutes

“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 (J&J) 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 (IP) 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.

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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 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.

Aid workers check a shipment of vaccines against the


coronavirus sent to Sudan by the Covax vaccine-sharing
initiative in October 2021 | Ebrahim Hamid/AFP via Getty
Images

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
(EFPIA), 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 (TRIPS), 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. 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.

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 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.

POLITICO and the Bureau of Investigative Journalism tracked


what the COVID-19 pharmaceutical giants paid lobbying
consultancies in 2020 and 2021. See the lobbying web here.
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 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 Warwick


Law School, 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 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, 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, the Bureau, and the
Corporate Europe Observatory, a research group focusing on
the influence of corporations.

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
vaccines to increase access.
European Commission President Ursula Von der Leyen, during
a visit to Pfizer’s plant in Puurs | Benoit Doppagne/AFP via
Getty Images

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. These three countries also house significant
pharmaceutical industries: Ireland is the largest net exporter in
the EU of pharmaceutical products; they make up Sweden’s
second-largest export category in value; and almost a fifth 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.”

A queue to get vaccinated in Siliguri, India, in September 2021 |


Diptendu Dutta/AFP via Getty Images
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 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 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.

Vials for the BioNTech/Pfizer vaccine in Saint-Remy-sur-Avre,


west of Paris | Pool photo by Christophe Ena/AFP via Getty
Images

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 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.

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