EU yet to decide on legal case against AstraZeneca over shortfall

The European Commission has said no decision had yet been taken on whether to launch legal action against AstraZeneca over a shortfall in deliveries of coronavirus vaccine doses, after Ireland’s health minister said the case had been initiated.

Health Minister Stephen Donnelly on Thursday told the Irish parliament that “a legal case has been initiated by the commission and earlier this week I have joined Ireland as one of the parties to that legal case.”

A spokesman for the European Commission later said, however, that a final decision had not yet been taken.

“No decision to launch legal actions has been taken at this point in time,” a spokesman for the commission said.

‘Looking at all options’

Sources familiar with the situation have told Reuters news agency the commission was working on legal proceedings after the drugmaker cut deliveries to the European Union.

The matter was discussed on Wednesday at a meeting with EU diplomats, where most of the bloc’s member states supported the legal action, two diplomats told Reuters.

However, its largest, Germany and France, asked for more time to think about the possible move, the diplomats said.

“What matters is that we ensure the delivery of a sufficient number of doses in line with the company’s earlier commitments,” a commission spokesman said in an emailed statement.

“Together with the member states, we are looking at all options to make this happen.”

A spokesman for AstraZeneca said the company was not aware of any legal proceedings “and continues to hold regular discussions on supply with the commission and member states”.

Brussels in March sent a legal letter to the company in the first step of potential court proceedings.

When the deadline for a reply expired this month, a spokesman for the commission said the matter was discussed in a meeting with AstraZeneca but the EU was still seeking further clarification from the company on “a number of outstanding points”.

The spokesman did not elaborate, but details of the letter published by Italian newspaper Corriere della Sera show the EU was seeking clarification on what it deemed a delayed application to the EU regulator for approval of the vaccine.

EU opts not to buy extra doses

Brussels also questioned how AstraZeneca spent more than 224 million euros ($270 million) granted by the EU in September to buy vaccine ingredients and for which the bloc said the company had not provided sufficient documents confirming the purchases.

Under the contract, the company had committed to making its “best reasonable efforts” to deliver to the EU 180 million vaccine doses in the second quarter, for a total of 300 million in the period from December to June.

But the company said in a statement on March 12 it would aim to deliver only one-third of that. The EU letter was sent a week after that statement.

Under the contract, the parties agreed that Belgian courts would be responsible for settling unresolved disputes.

The EU has already decided not to take up an option to buy 100 million extra doses of AstraZeneca under the contract, an EU official said, after safety concerns about very rare cases of blood clots linked to the vaccine as well as supply delays.