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Commission, AstraZeneca fire shots in court – POLITICO

How come?

On Wednesday, a bitter dispute between AstraZeneca and the European Commission was publicly broadcast for the first time – supported by the 27 EU member states. The battle began back in January when the drug maker announced its initial delivery delays and months later essentially resulted in a divorce between the two once optimistic partners.

EU lawyers argued that the company had made no effort to feed the EU and now needed a judge to get the company to hurry.

“Millions of Europeans are deprived of the vaccine, can become infected with the virus and become sick or even die – this is where the urgency lies,” said EU lawyer Fanny Laune. “Fundamental rights are at stake.”

AstraZeneca’s attorneys countered that both parties were aware they were signing a contract for a brand new coronavirus vaccine that would be difficult to make worldwide, let alone be approved by regulators.

“I … got the impression that we were talking about a contract to supply shoes, t-shirts or books,” said Hakim Boularbah, one of AstraZeneca’s lawyers, from the commission. “This was an entirely new vaccine … to treat a virus that had been around for a little over a year.”

Often times the hearing went back and forth over whether the Anglo-Swedish company had betrayed its EU treaty by giving the UK more doses. Amid gilded paintings of a man on a throne and stabbing another man in the back, a rotating group of EU lawyers argued that the EU case gave priority to the UK, what the EU considered betraying its treaty was viewed.

They pointed out that AstraZeneca supplied 37 percent of the promised doses to the UK, but only 18 percent of the EU treaty.

“AstraZeneca made a conscious choice to prefer the UK and therefore to freeze its production units completely [there]”said Paul Alain Foriers, the highest lawyer representing the EU.

However, it was unclear what all the fighting in a courtroom would do. The commission argues that the point is to get more doses as soon as possible, but their lawyers have also put in place fines – € 10 per dose per day, with each vaccine delayed – if a court rules in favor of the EU, AstraZeneca however, a schedule that has been postponed by three months cannot adhere to it.

And AstraZeneca, which has tried to be the top vaccine producer for the world rather than the richest in the world, asked why the bloc needed so many vaccines right away.

In the court of public opinion, the Oxford / AstraZeneca vaccine has often been written off in favor of mRNA recordings: citizens refuse vaccination appointments to get the vaccine against viral vectors, and governments have stopped using the vaccine citing safety elderly populations limited concerns about very rare side effects.

EU officials have publicly said that without the Oxford / AstraZeneca sting, the block would be better off in its future vaccine portfolio anyway, the drugmaker’s lawyers stressed.

As Boularbah put it, it is “shocking that some members are asking about doses of a vaccine they have said they will no longer use”.

A shot

The main goal of the EU lawyers was to convince the court that it must intervene in order for the vaccine maker to deliver the 300 million doses to the block by the end of September. This would be a three month delay in the company’s original delivery schedule. However, the company has announced that it will deliver the entire 300 million cans by the end of December – six months later.

If AstraZeneca can’t stick to a schedule three months later, the EU wants the company to pay € 10 per dose per day if each vaccine is delayed. Considering that the company is expected to deliver 100 million cans out of the 120 million cans required by the EU by the end of June, the company will pay € 200 million per day from July 1st. Commission spokesman Stefan De Keersmaecker later made it clear that penalties are standard in procedural law.

“We are not interested in the penalties, as such we are interested in receiving the cans,” said De Keersmaecker. “The penalties are intended to ensure that the company complies with the dispensing of cans.”

The EU case focused on convincing a judge that the bloc needed these doses immediately, arguing that countries that had previously supplied vaccines were able to contain the virus and reduce death rates.

According to EU lawyers, the issue was that the company was not doing everything in its power to supply the bloc. Two UK sites where vaccines are manufactured are clearly included in the EU’s extended sales contract and should have been used to supply the block, EU lawyers repeated earlier that morning. When the first problems with a Belgian site were identified, AstraZeneca also redirected production from the Dutch production facility Halix to the EU. But that was not enough for the EU.

“If two locations are not enough to execute the contract, AstraZeneca will have to look for a third location and so on,” said EU lawyer Rafaël Jafferali.

Not so fast

Boularbah said he was surprised that the commission’s lawyers had not once mentioned that AstraZeneca sold its vaccine at cost of production rather than for profit.

“This is an essential element in the interpretation of the treaty,” he said.

He noted that AstraZeneca’s lawyers had already told the Commission on July 24, 2020 that there would initially only be two manufacturers of drugs or the vaccine liquid. One would be in the EU and the other in the US (A point that raises questions as the EU treaty says the US would only act as a backup facility.) The two UK drug makers would start using them once they were delivered 100 Millions of cans to the UK, which had negotiated a priority for the cans coming from the locations there.

The pharmaceutical company’s lawyers concluded that the EU is now trying to essentially rewrite the contract by asking the court to impose new, strict delivery deadlines and penalties.

The next deadline is June 4th, which is when the lawyers return to answer any questions from the judge.

The judge will make a decision within the month, but is expected to do so sooner. The Commission is also pursuing another case against AstraZeneca, which is investigating the merits of the underlying complaint.

Regardless of who has the upper hand in this round, the two parties will meet again in September for the next round of divorce.

This article is part of POLITICOPremium Policy Service: Pro Health Care. Our specialist journalists keep you up to date on drug prices, EMA, vaccines, pharmaceuticals and more, and keep you updated on the issues that are driving the health policy agenda. E-mail [email protected] for a free trial.

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