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3rd Dec 2022

EU controls vaccine exports, as AstraZeneca jab approved

  • Meanwhile, the European Medicine Agency authorised the use of the vaccine developed by Astrazenca and Oxford in the EU (Photo: gov.bc.ca)

The European Commission adopted, on Friday (29 January), an export control mechanism on vaccines produced in EU countries - as a response to the shortfall of vaccines suddenly announced by the pharmaceutical company AstraZeneca earlier this month.

"The aim is to provide greater clarity on vaccine production in the EU and their exports - this transparency has been lacking and is vital at this time," said EU trade commissioner Valdis Dombrovskis.

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This follows several days of back and forth, with phone calls and meetings, previously described as unsatisfactory due to the "the lack of clarity" over AstraZeneca's delayed deliveries.

Now the companies, with whom the EU has signed agreements, will have to notify national authorities and the commission whenever they want to export vaccines to third countries to receive an authorisation.

"This is not a ban," that would be "the last option," EU officials said, adding that "there is a clear right for the EU and all member states to know where the vaccines are ending up".

For the contract with AstraZeneca, the European Commission has allocated €336m - although part of the funding has not been paid yet.

A group of countries, including Iceland, Liechtenstein, Norway, and Switzerland and the 92 low and middle-income countries involved in the World Health Organization-led Covax initiative, are excluded from this scheme.

Other countries such as the US, Canada, or the UK are not exempt - increasing concerns over a potential ban on vaccines to the UK.

"This is not Europe first. We are not in a race against any country. We want to reach a fair approach. This is our insurance policy," EU officials said.

The control scheme, which enters into force on Saturday, will run only for the first quarter - but it might be extended for some extra weeks.

Meanwhile, the European Medicine Agency (EMA) recommended on Friday the use of a vaccine developed by AstraZeneca and Oxford in the EU, but acknowledged the lack of data on its effectiveness for senior citizens.

Germany's Robert Koch Institute said earlier that there was "insufficient data" to prove the vaccine's effectiveness in older populations.

The EU, on behalf of member states, has secured 300m doses of the AstraZeneca vaccine, with an option for a further 100m doses.

"Best-effort" clause

Following months of growing pressure from MEPs and civil society, the commission finally published the redacted contract signed with AstraZeneca in August.

But key parts of the agreement remained confidential. For example, the number of doses that AstraZeneca has promised to the EU for the first quarter of this year.

Some "95 percent of the [redactions] come from the company," said a commission official.

So far, Brussels has refused to clarify how significant AstraZeneca's shortfall would be, but Reuters has reported that deliveries would be cut to 31 million doses - a reduction of 60 percent.

Earlier this week, the company's CEO Pascal Soriot said that the agreement was based on a "best-effort" basis - meaning there is no legal obligation to fulfil the order set up by the EU for the first quarter.

"Anyway, we didn't commit with the EU, by the way… We said we are going to make our best effort…But our contract is not a contractual commitment. It's a best effort," Soriot said in an interview.

EU officials, however, told reporters on Friday that the "best-effort" clause was "an objective legal standard" that could be measured by any judge, if necessary.

Additionally, Brussels said that differentiating the UK and EU supply chains is not foreseen in the contract, insisting that UK plants are not "optional" or "backup" but part of the contract.

The agreement with AstraZeneca foresees manufacturing in several plants in Europe - two in the UK, one in Belgium, one in Germany, and one in Italy.

EU-AstraZeneca row flares up after vaccines shortfall

"The view that the company is not obliged to deliver because we signed a 'best effort agreement' is neither correct nor acceptable," said EU health commissioner Stella Kyriakides, after the company's CEO tried to justified delayed deliveries to the EU.

Analysis

The EU's vaccine strategy - the key points

As the EU Commission gets entangled in a dispute with one of the vaccine producers and gets heat for the perceived slow roll-out of the vaccines, we take a look at what the EU has done and not done.

Commission silent as Germany buys own vaccines

The European Commission refused to comment on whether a bilateral deal between Germany and BioNTech for 30 million additional vaccines is a breach of EU collective purchase agreements - which forbid member states from negotiating separate deals.

Commission blames Irish border cock-up on trade chief

The EU Commission caused uproar in Ireland and the UK when - in a rush to agree on a new regulation to control vaccine exports from the EU - the bloc's executive triggered a clause in the Brexit divorce deal.

EU gets vaccines boost amid fears over uneven global supply

Pharmaceutical companies will increase their supply to member states with millions of additional doses, after a heated dispute over delayed deliveries. Meanwhile, the bloc's new control mechanism on vaccine exports faces global criticism amid fears of 'vaccine nationalism'.

Vaccine export 'ban' row heats up ahead of EU summit

"This is not about banning vaccine exports, this is about making sure that companies deliver on their commitments to the member states and the EU that are inscribed in contracts," commission spokesman Eric Mamer said.

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