Sandra Gallina’s next big fight – POLITICO

You can’t miss Sandra Gallina. The head of the European Commission’s health division is tall, loud and Italian. As one Commission official put it: She sucks the air out of a room, but not necessarily in a bad way.

In her previous job as the Commission’s deputy director general for trade — long before she was tapped to lead the European Union’s vaccine procurement effort — Gallina built a reputation as a fierce negotiator, yelling, swearing and, by one account, cuffing one of her teammates on the back of the head in front of a room full of negotiators.

Her take-no-prisoners approach was one reason Commission President Ursula von der Leyen wanted her on the front lines during the pandemic, fighting to buy the EU’s coronavirus vaccines.

And fight she did. Over the course of 18 months, Gallina led the chaotic, unprecedented — and ultimately triumphant — vaccine procurement effort, securing more than 4.5 billion doses and ultimately vaccinating at least 275 million people.

Now von der Leyen wants to take this work further, with the first step of what she’s called the European Health Union. The Commission’s most recent proposal for the European Health Emergency Preparedness and Response Authority — or HERA, for short — will make Gallina and her team’s effort permanent.

Just as the Commission handled vaccine purchases for the entire bloc, HERA will be in charge of doing it again in the event of another crisis by funneling billions of euros into vaccine and medicine research, purchasing and manufacturing.

But the Commission getting more health powers in many ways hinges on convincing capitals to put more control in the hands of people like Gallina — and that might not be so easy.

Von der Leyen’s health ambitions once enjoyed widespread encouragement, including from German Chancellor Angela Merkel. But now, with more than 70 percent of the bloc’s adults immunized, the EU’s national governments are no longer so convinced.

The Commission’s vaccination blitz was successful, yes, but it was also contentious — especially in the early months when the EU’s efforts lagged far behind those of the United States and the United Kingdom. And Gallina at times struggled to bring and keep the EU’s 27 member countries together.

After months of pushback against her proposals, von der Leyen has resized her ambitions, even weakening the proposal for HERA — which she is pushing through using a legal mechanism that doesn’t allow the European Council or Parliament to object.

EU leaders, it seems, are largely on board with giving the Commission some basic ability to act in an emergency, but not much else — raising the question of whether the upcoming expansion of the EU’s health power is coming into effect thanks to the success of Gallina and her team, or despite their numerous stumbles.

Vaccine gamble

At the heart of the Commission’s argument for an expansion of its powers is Gallina’s performance during the peak of the crisis, as the EU scrambled to secure enough vaccine doses to bring the pandemic under control.

That effort began in the summer of 2020, with Gallina sitting in her office, trying to decide which of the more than 100 vaccines being developed to take a bet on. Her 30 years in the Commission and her bulldozer reputation made her just the right person to run the previously sleepy DG SANTE as it was thrust into the spotlight. “She is the most political director general in SANTE, maybe ever,” one Commission official said.

But it wasn’t easy shopping. Gallina faced a limited budget, legal constraints, uncooperative EU national governments and phalanxes of pharma lawyers. She also suffered from a total lack of health experience. Undeterred, according to another Commission official, she turned to her team of EU negotiators, including Commission officials and member country representatives, and told them: “We will prevail.”

By at least some measures — as the Commission is eager to stress — they did. Gallina and her team amassed one of the widest and largest vaccine portfolios in the world, and today life on the Continent is beginning to return to something approaching normal. Speaking in September, Gallina’s deputy Pierre Delsaux championed Gallina’s approach: “When people were dying, or sick, making sure that 27 members did work together, continue to be solidaire … that’s amazing.”

But Gallina and her team also made notable missteps. The EU was months behind the U.S. and the U.K., in large part because one of the bloc’s gambles went wrong, forcing the Commission to drag AstraZeneca to court. Had the EU rolled out vaccines in the early months at the same pace as the U.S. or the U.K. many European lives might have been saved.

Gallina bears responsibility for both the successes and the failures. She credits herself and her experts with getting reluctant countries to sign up to buy mRNA shots like the BioNTech/Pfizer and Moderna vaccines in the first place. And she successfully fended off a coordinated effort by Big Pharma for the EU to change its liability laws.

One Commission official credits Gallina’s negotiating style as key to speeding up the talks. She might have a fierce reputation for shouting and banging to get her way, but the official said she was best at mollifying drug companies during tense talks, knowing exactly what to say and when to get them on board.

It wasn’t an easy task, playing the “middle man” between 27 countries and well-lawyered drug companies. “That’s not a comfortable job to have,” a pharmaceutical representative said: “She was frustrated, not just with Pharma, but just the sheer time it took to negotiate.”

Most of the trouble came after the contracts were signed. Gallina, who worked through the Christmas holidays without a break, panicked when the European Medicines Agency lagged behind the U.S. and U.K. in approving the BioNTech/Pfizer vaccine. She was furious when she was told that AstraZeneca would deliver significantly fewer doses than it had promised. Frustrated, she yelled over the phone and video, according to an EU official.

“I would like to stress that in spite of the extreme frustration I stayed professional,” Gallina wrote in a statement to POLITICO. “I would like to recall that people were dying and that AstraZeneca was not giving any credible explanations for the shortfall in scheduled doses.”

Gallina, along with other EU officials, was exasperated by the company’s failure to provide a clear explanation for months of shortages. At one point, the Italian government sent military police to raid a manufacturing facility in case missing doses were being stored in a warehouse in preparation for export.

EU officials stress that they could not have known AstraZeneca would violate its contract by giving the U.K. priority access. But lawyers who studied the agreements say that part of the issue was that DG SANTE’s contracts were written more like EU directives than supply contracts; they even let companies off the hook for delivery delays. One former top EU health official described Gallina’s contracts as “naive.”

Everyone knew that these companies had expert lawyers and a long list of potential buyers, said Yannis Natsis, a policy manager at the European Public Health Alliance, a public health advocacy group. The point of the vaccine strategy was for the EU to get to the front of the queue for vaccines, he added. But, in the end, “we were looking for those in warehouses.”

Knocking heads

Gallina’s drive to deliver and the mixed verdict on her performance won’t have come as a surprise to those who have watched her career. In three decades of working for the EU, she made a name for herself as a tough negotiator with a sometimes-abrasive approach, but also a champion of the EU ready to fight all comers.

An Italian born in Venezuela, Gallina kicked off her Brussels career in 1988, as one of a host of interpreters hired after Spain and Portugal joined the EU. Interviewed at the time by the BBC, she described Brussels as a “veritable Tower of Babel.” “Just walking along a corridor, you could come across two, three or four different languages,” she said.

Gallina rose through the ranks. By the beginning of the new century, she was representing the EU at the World Trade Organization as a lead negotiator. Cecilia Emma Sottilotta, who as an intern at the Italian mission to the WTO in 2007 crossed paths with Gallina on several occasions, said she was “formidable” and “commanded the discussion.” In a negotiation, Sottilotta said, “I would not want to be on the other side.”

Sottilotta, now at the American University of Rome, recalled she wanted to be like Gallina when she grew up, but not everyone was as impressed. Former colleagues describe her as divisive: “You can absolutely love her or dislike her, and you often do both within the same day,” one said.

An EU official who worked with Gallina for years at DG TRADE described her as susceptible to “deciding too quickly, without enough consideration for the downsides; and even more the risk of upsetting people, including high-ranking ones.”

Before vaccines, Gallina’s most high-profile task was as lead negotiator of the Mercosur trade talks with the South American trade bloc.

Gallina was not a typical diplomat. “Her style at first really puzzled the other side,” said one official who worked closely with Gallina throughout the Mercosur talks. “Nobody knew how to handle Sandra when she took over.”

She was blunt and often funny: “Chances are high that she will make you blush,” said a diplomat from a Mercosur country.

The Mercosur diplomat said Gallina could also be unprofessional. On at least one occasion, she told a senior representative from a Mercosur country “in perfect Spanish” something like, “you’d better be ready to go along with these demands, otherwise … everything goes to hell,” recalled the Mercosur diplomat.

In July 2016, while part of an EU delegation to the fourteenth round of the United Nations Conference on Trade and Development, Gallina didn’t like how a U.K. official was negotiating. According to witnesses, as the official sat in the EU negotiating chair in front of around 30 delegations, she hit her colleague on the back of the head.

One official described it as a “hard, audible cuff to the back of the head.”

Gallina “strongly” denied cuffing the U.K. official or acting unprofessionally with the Mercosur official, adding “I have always worked with the highest professional standards including under extreme pressure.”

Trouble on the home front

As head of the Commission’s vaccination effort, Gallina spent a good part of the pandemic tussling with national governments. The highest point of tension came at the end of March 2021, when Austrian Chancellor Sebastian Kurz threatened to block a deal to buy more BioNTech/Pfizer vaccines if his country and a few others did not get a larger share of doses.

Diplomats from other countries were livid. There was disagreement over whether Austria even had the ability to block such a deal. According to diplomats present, things got heated when Gallina wouldn’t give them a straight answer.

Some diplomats said they felt that she was trying to help Kurz, and they were not happy about it. In one especially tense moment, Gallina became defensive when a diplomat said she wasn’t being helpful. She shot back something along the lines of “Why am I here?”

As one diplomat recalled: The scrutiny was becoming excessive and “she took it badly.”

After that, Gallina moved out of the spotlight. When the Commission announced its biggest-ever deal for 1.8 billion BioNTech/Pfizer doses, von der Leyen took the credit. Gallina’s name wasn’t mentioned in the New York Times article that described how the agreement came about. And when it comes to HERA, the Commission’s proposed emergency public health effort, Gallina will not be in the driving seat. The authority will be run by her deputy Pierre Delsaux.

Gallina turned down multiple requests to be interviewed for this piece, but she did respond to a question about how she planned to tackle the wide array of files she’s in charge of, now that she’s bought the vaccines for the bloc. In an email, she stressed that she’s been “exerting full powers and following absolutely all files.”

“There are fascinating ones that will continue to need my steer: Pharma Strategy, European Health Union, Cancer Plan, European Health Data Space, AMR, Farm to Fork and food sustainability framework legislation, Food Waste, Sustainable Use of Pesticides, Animal Welfare, Food labelling, New Genomic Techniques, just to mention a few,” she wrote.

When it comes to expanding the Commission’s heath powers, however, Gallina is likely to be far less busy than she might once have hoped to be.

The EU’s national governments — long jealous of any attempt to loosen their grip on health policy — have largely acquiesced to the Commission’s decision to push HERA into existence without their explicit approval. One EU official said it only makes sense to continue the EU-level approach Gallina spearheaded: “Fuck, it’s clearly working.”

But von der Leyen’s dream of a health union is a shadow of the big plans she was proposing a little more than a year ago. Even HERA, the Commission’s hallmark proposal, has been scaled down from a plan to make it a standalone agency that would be the European equivalent of the U.S.’s Biomedical Advanced Research and Development Authority (BARDA), which was key to allowing the U.S. to invest massive amounts of money into vaccines and treatments months before the EU. 

Even in its reduced form, HERA is not without its critics. Some national governments are angry about a provision in the proposal that would give them only a monitoring role, instead of being able to decide on the Commission’s purchasing decisions as they did with vaccines. Civil society groups and the European Parliament have also taken issue with what they say is a lack of oversight on the funds the authority will spend.

While these objections are unlikely to derail HERA, the contention has contributed to a souring of attitudes over any further expansion of Brussels’ authority. Expanding health powers has always been an uphill battle, but the issues with the vaccine rollout certainly did not help the Commission’s case. Asked if the Commission would get the power to do more beyond emergencies, another diplomat said: “Big fat no thank you very much.”

Yannis Natsis, the policy manager at the European Public Health Alliance, is already concerned that health is slipping as a priority — largely thanks to the vaccines Gallina helped buy: “I fear that as the pandemic is coming under control, I fear that we’re going to go back to … health being considered small.”

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