After suing AstraZeneca for falling far short of its promise to deliver 300MM doses of its vaccine to the EU by the end of the year (so far, it's only on track to deliver roughly one-third of that due to manufacturing hiccups and other issues).
The vaccine, which is still in widespread use despite evidence of rare but sometimes deadly cerebral blood clots, was designed by Anglo-Swedish pharmaceutical giant with cooperation from Oxford University. The EU took the company to court back in April after the company confirmed that deliveries would likely fall far short of expectations.
The EU's struggle to compensate for this shortfall has at times led to hostility with its neighbors, including the newly independent UK. The EU's ruling body, the European Commission, nearly ordered a ban on all exports produced on the continent to claim more supplies for Europeans, but ultimately that plan was quashed.
Still, Brussels wants the company to deliver at least 120M doses by the end of June. AstraZeneca had delivered only 50M doses as of the beginning of May, though it has likely delivered at least a few million more by now. Still, 50MM is only a quarter of the 200MM that were expected to be delivered by now.
A lawyer for the EU told Reuters that the bloc is seeking monetary compensation for each promised dose that wasn't delivered. The rate proposed by the EU would be roughly €10 ($12) per day of delay per dose, starting July 1. At that rate, the fine would amount to $12M per million vaccines per day, or roughly $2.4 billion per day if the number missing is still 200MM.
Brussels wants the company to deliver at least 120 million vaccines by the end of June. AstraZeneca had delivered 50 million doses by the beginning of May, just a quarter of the 200 million vaccines foreseen in the contract by then.
"AstraZeneca did not even try to respect the contract," the EU's lawyer, Rafael Jafferali, told a Brussels court in the first hearing on the substance of the legal case.
He said the EU was seeking 10 euros ($12.2) for each day of delay for each dose as compensation for AstraZeneca's non-compliance with the contract. This penalty would apply from July 1, 2021, if the judge accepted it.
Jafferali said the EU was seeking an additional penalty of at least 10 million euros for each breach of the contract that the judge may decide.
A lawyer for AZ denounced the accusations as "shocking" and argued that manufacturing vaccines is fraught with complexities that sometimes can't be anticipated.
"This is not a contract for the delivery of shoes or T-shirts," AstraZeneca's lawyer Hakim Boularbah told the court later on Wednesday, stressing the complexity of manufacturing a new vaccine.
The EU accusations were "shocking", Boularbah said, noting the company had formulated its delivery targets based on early estimates of production capacity. He added that the vaccine was sold at cost.
AstraZeneca has repeatedly said the contract was not binding as it only committed to make "best reasonable efforts" in delivering doses.
Jafferali said that principle had not been respected because the drugmaker had not delivered to the bloc 50 million doses produced in factories that are listed in the contract as suppliers to the EU, including 39 million doses manufactured in Britain, 10 million produced in the United States and 1 million in the Netherlands.
AZ's factories in Britain, and their refusal to export vaccines, is central to the lawsuit. The company claims that it fulfilled its commitments by alerting the EU to production delays.
AstraZeneca's lawyer said the British factories were mentioned in the EU contract for information, but there was no commitment to use them. They were expected to produce vaccines solely for Britain until February 2021, when the company expected to deliver 100 million doses to London. It has not yet completed its deliveries to Britain.
Jafferali said AstraZeneca had pledged in the EU contract not to have other engagements that would prevent it from abiding by the terms of the deal.
The lawyer also said AstraZeneca had failed to communicate to the EU in a timely manner the magnitude of its supply problems because it repeatedly sent messages, including publicly, that it was able to meet its targets, before finally admitting there were large shortfalls in March.
The company had warned the EU in December of production problems, but communicated only at the end of January, just before the start of deliveries, a much larger cut than initially expected for the first-quarter.
Boularbah said AstraZeneca had continuously kept the EU informed about its production plans and problems.
A verdict is expected next month.