EU tightens vaccine export rules, publishes AstraZeneca deal

Lorne Cook and Samuel Petrequin
Associated Press

Brussels – The European Union introduced tighter rules Friday on exports of coronavirus vaccines that could hit shipments to nations like the United Kingdom amid a deepening dispute with drugmaker AstraZeneca over supplies of potentially lifesaving shots.

The Northern Ireland government immediately lashed out at the move, saying the bloc invoked an emergency clause in its divorce deal with Britain that could allow it to halt vaccine exports to the small territory.

Goods are supposed to flow freely between the EU and Northern Ireland under special arrangements for the U.K. region designed to protect the peace process on the island of Ireland.

The AstraZeneca office building in Brussels, Friday, Jan. 29, 2021.

Politicians in Northern Ireland condemned the move and the British government said it was concerned. An EU official who could not speak on the record because the information has yet to be made public, said the scope of the emergency rules limiting exports were still being discussed.

“The European Union has once again shown it is prepared to use Northern Ireland when it suits their interests but in the most despicable manner – over the provision of a vaccine which is designed to save lives,” said Arlene Foster, leader of Northern Ireland’s government.

Earlier, the 27-nation bloc and AstraZeneca made public a heavily redacted version of their vaccine deal that’s at the heart of a dispute over the delivery schedule.

The contract, agreed to last year by the European Commission and the drugmaker, allows the EU’s member countries to buy 300 million doses of the AstraZeneca vaccine, with an option for a further 100 million doses. It’s one of several contracts the EU’s executive branch has with vaccine makers to secure a total of more than 2 billion shots.

As part of an “advanced purchase agreement” with companies, the EU said it has invested 2.7 billion euros ($3.8 billion), including 336 million ($408 million) to finance the production of AstraZeneca’s serum at four factories.

The EU lashed out at the British-Swedish drugmaker this week after the company said it would only supply 31 million doses of vaccine in initial shipments, instead of the 80 million doses it had hoped to deliver. Brussels claimed AstraZeneca would supply even less than that, just one-quarter of the doses due between January and March – and member countries began to complain.

The European Commission is concerned that doses meant for Europe might have been diverted from an AstraZeneca plant on the continent to the U.K., where two other company sites are located. The EU also wants doses at two sites in Britain to be made available to European citizens.

AstraZeneca CEO Pascal Soriot told Germany’s Die Welt newspaper this week that the U.K. government helped create the vaccine developed with Oxford University and signed its contract three months before the EU did. Soriot said that under the British contract, vaccines produced at U.K. sites must go to the U.K. first.

To head off similar disputes and allay fears that vaccines might be diverted, the Commission introduced measures Friday to tighten rules on the exports of shots produced in the 27 EU countries. The “vaccine export transparency mechanism″ will be used until the end of March to control shipments to non-EU countries and ensure that any exporting company based in the EU first submits its plans to national authorities.

The EU insisted that’s not an export ban, although it could be used to block shipments to the UK or other non-EU countries.

Officials said it is intended to ensure member nations get the shots they bought from producers. They said the mechanism would not affect humanitarian deliveries and shipments to countries covered by the COVAX initiative co-led by the World Health Organization – meant to ensure less wealthy parts of the world have equitable access to COVID-19 vaccines.

In an interview with The Guardian newspaper, French president Emmanuel Macron accused AstraZeneca of lack of transparency and said exports should be controlled “because there is questionable behavior and we will be receiving fewer deliveries that do not honor the contractual engagements agreed.”

The World Health Organization criticized the new EU export rules as “not helpful.”

Director General Tedros Adhanom Ghebreyesus and other WHO officials warned of supply-chain disruptions that could ripple through the world and potentially stall the fight against COVID-19.

The “advanced purchasing agreement” with the EU was signed in August, before the Oxford-AstraZeneca vaccine had been properly tested. The European Medicines Agency approved the vaccine on Friday, making it the third authorized for use by EU nations.

Much of the 41-page document made public was blacked out, making it very difficult to establish which side is in the right. Details about the price of the vaccine were notably redacted. The U.K. is thought to be paying far more for the vaccine than EU countries.

An EU official said 95% of the blackened text is a result of requests from AstraZeneca.

To the uninitiated, the contract is not easily understood. However, it is laden with references to a “Best Reasonable Effort” being made on items like deliveries and volumes, given the uncertainty surrounding the development of the vaccine when it was drafted.

AstraZeneca might say only it can decide whether it’s doing its best, but the EU argues that this is a legal term and that only a judge can decide whether the company has made a “Best Reasonable Effort,” meaning the truth of the matter might lie in the hands of the two sides’ lawyers.

In addition to the dispute with AstraZeneca, delays or production problems with the Pfizer-BioNTech vaccine have caused a political uproar across the EU.

Nearly two weeks after France extended its vaccine campaign to people over 75 years old, elderly residents in Paris are flocking to vaccination centers amid fears that daily injection rates will soon drop because of a shortfall.

In Italy, virus czar Domenico Arcuri blasted the delivery delays, which he said had so far deprived the country of 300,000 doses and drastically slowed down its campaign to inoculate older adults.

Arcuri said drugmaker Moderna had joined Pfizer and AstraZeneca in announcing delays, saying the pharmaceutical company had advised the Italian government of a 20% cut in planned deliveries of the Moderna vaccine the week of Feb. 8.

“A vaccine is not a soft drink or a snack,” Arcuri said. “With all due respect to soft drinks and snacks, the vaccine is the only antidote to get out of this (dark) night that has lasted a year.”

Associated Press writers Danica Kirka in London, Nicole Winfield in Rome, Jamey Keaten in Geneva and Thomas Adamson in Paris contributed to this report.