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Belgian court finds AstraZeneca should have used UK production to meet EU contract

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Today (18 June) Belgium’s Court of First Instance published its judgement on the case brought against AstraZeneca (AZ) by the European Commission and its member states for interim measures. The court found that AZ failed to meet “best reasonable efforts” outlined in its advance purchase agreement (APA) with the EU, importantly the court found that the Oxford production facility had been monopolized to meet UK commitments despite explicit references to it in the APA.

AZ’s actions triggered the European Union to enact very carefully circumscribed trade restrictions that were targeted at addressing this problem.

AstraZeneca will need to deliver 80.2 million doses by the end of September or incur a cost of €10 for every dose it fails to deliver. This is a long way from the European Commission’s request for 120 million vaccine doses by the end of June 2021, and a total of 300 million doses by the end of September 2021. Our reading of the judgement suggests that with the acknowledgement that the UK production should be used to meet the EU’s requirements and other production in other non-EU countries coming online these doses are probably now within reach.

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The decision has been welcomed by AstraZeneca and the European Commission, but costs were allocated on a 7:3 basis with AZ covering 70%.

In its press release AstraZeneca General Counsel, Jeffrey Pott, said: “We are pleased with the Court’s order. AstraZeneca has fully complied with its agreement with the European Commission and we will continue to focus on the urgent task of supplying an effective vaccine.”

However, in its statement the European Commission welcomes the judges finding that AstraZeneca committed a serious breach (‘faute lourde') of its contractual obligations with the EU.

The President of the European Commission, Ursula von der Leyen said: “This decision confirms the position of the Commission: AstraZeneca did not live up to the commitments it made in the contract.” The Commission also says that the Commission’s “sound legal basis” - that some had brought into question - had been vindicated. 

In their press release AstraZeneca stated: “The Court found that the European Commission has no exclusivity or right of priority over all other contracting parties.” However, this wasn’t at issue, the court called for proportionality when there are conflicting contracts.

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Ensuring smooth air travel while checking EU Digital COVID Certificates: New guidelines for member states

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Following the launch of the EU Digital COVID Certificate on 1 July, the European Commission has issued guidelines for EU member states on the best ways to check them before travel, ensuring the smoothest possible experience for air passengers and staff alike. The non-mandatory EU Digital COVID Certificate provides either proof of vaccination, shows if a person holds a negative SARS-COV-2 test result, or has recovered from COVID-19. Therefore, the EU Digital COVID Certificate is essential to support the re-opening of safe travel.

As passenger numbers will rise over the summer, an increased number of Certificates will need to be checked. The airline sector is particularly concerned by this since, in July for example, air traffic is expected to reach more than 60% of 2019 levels, and will rise thereafter. Currently, how and how often passenger's Certificates are checked, depends on the holder's departure, transit and arrival points.

A better-coordinated approach would help avoid congestion at airports and unnecessary stress for passengers and staff. Transport CommissionerAdina Vălean said: “Reaping the full benefits of the EU Digital COVID Certificate requires the harmonization of the verification protocol. Cooperating for a ‘one-stop' system to check the certificates makes for a seamless travel experience for the passengers across the Union.”

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To avoid duplication, i.e. checks by more than one actor (airline operators, public authorities etc.), the Commission recommends a ‘one-stop' verification process prior to departure, involving co-ordination between authorities, airports and airlines. Moreover, EU member states should ensure that the verification is carried out as early as possible and preferably before the passenger arrives at the departure airport. This should ensure smoother travel and less burden for all involved.

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EU agrees to recognize Swiss COVID certificates

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Today (8 July) the European Commission adopted a decision recognizing Swiss COVID-19 certificates as equivalent to the EU Digital COVID Certificate. This should considerably ease travel between Switzerland and its neighbours.

Switzerland is the first country from outside the 30 countries of the EU and EEA area, to be connected to the EU’s system. The Swiss COVID certificates will be accepted in the EU under the same conditions as the EU Digital COVID Certificate. Swiss nationals, EU citizens, and third-country nationals legally staying or residing in Switzerland will be able to travel inside the EU under the same conditions as holders of an EU Digital COVID Certificate. 

Justice Commissioner, Didier Reynders, said: “I warmly welcome that the Swiss authorities have decided to implement a system based on the EU Digital COVID Certificate. This will allow EU citizens and Swiss nationals to travel safely and more freely this summer.” 

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Switzerland shall be connected to the EU Digital COVID Certificate trust framework.

Talks are still ongoing with the UK and other third countries.

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COVID-19 Therapeutics Strategy: Commission identifies five promising candidate therapeutics

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The EU Strategy on COVID-19 Therapeutics has delivered its first outcome, with the announcement of the first portfolio of five therapeutics that could soon be available to treat patients across the EU. Four of these therapeutics are monoclonal antibodies under rolling review by the European Medicines Agency. Another one is an immunosuppressant, which has a marketing authorisation that could be extended to include the treatment of COVID-19 patients.

Health and Food Safety Commissioner Stella Kyriakides said:“We are taking the first step towards a broad portfolio of therapeutics to treat COVID-19. Whilst vaccination is progressing at increasing speed, the virus will not disappear and patients will need safe and effective treatments to reduce the burden of COVID-19. Our goal is clear, we aim to identify more front-runner candidates under development and authorise at least three new therapeutics by the end of the year. This is the European Health Union in action.”

The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorisation by October 2021, the target set under the Strategy, provided the final data demonstrate their safety, quality and efficacy. See the Press Release and a Questions and Answers for further details.

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