the contract with the EU has been published – Corriere.it

The European Commission published the contract with AstraZeneca (than him pdf). This was announced by the EU executive itself. According to Reuters, the decision was made in agreement with the pharmaceutical company. The contract was previously confidential, as were those of Moderna and Pfizer-BioNTech.

Some parts of the document, including the two pages related to the economic value of the contract, are still covered by omissions.

The publication of the document comes after a week of very high tensions between the company and the European Union. The President of the EU Commission, Ursula von der LeyenHe said that the contract was very clear, the commitments contained in it precise. I understand that they have initial difficulties, but we want to know why they cannot comply with what is stipulated in the contract. AstraZeneca must administer the vaccine doses on time.

Why is the publication of the contract important?

A week ago, AstraZeneca informed the European Union that, following production difficulties at a factory in Belgium, supplies for the first quarter of 2021 will be lower than expected by 60 percent – for a total of 31 million doses instead of the planned 80.

The CEO of the company then explained that he had no obligations to the EU and had alluded to a clause in the contract that obliged AstraZeneca to make every effort to produce vaccines.

The Commission protested and launched a project for a mechanism capable of controlling the export of the vaccine from AstraZeneca plants to the EU. The EU had also proposed declassifying the contract.

Von der Leyen made it clear today that the best effort clause does not exist: or rather, it was only applicable as long as it was not clear whether the pharmaceutical company could develop a vaccine. That time has passed. The vaccine is there.

The contract states that AstraZeneca has made every effort to make reasonable efforts to deploying the capacity to produce 300 million doses with commission option upon request 100 million additional doses.

What is meant by maximum effort is clarified on page 3: all the activities and effort that a company of similar size, infrastructure and resources would launch, taking into account the urgent need for a vaccine to stop a pandemic with a serious impact in public health, the restriction of personal freedoms, the economy.

According to AstraZeneca, this reference is sufficient to demonstrate compliance with the agreements; For the Commission, AstraZeneca is a standard legal formulation used when purchasing a product that has not yet been authorized and does not refer to production factors as such.

Neither party, at least for now, intends to open a court case.

Delays due to force majeure

The contract establishes that, for reasons of force majeure, neither the Commission nor the Member States nor AstraZeneca will be liable to the other party nor will they be deemed to have violated the agreement.

Among the causes of force majeure mentioned in the agreement are fires, floods, earthquakes, hurricanes, foreclosures and other natural disasters.

They come excluded from definition service failures, equipment or material defects or delays in making them available, labor disputes, strikes and financial difficulties.

The doses of vaccine produced in Great Britain

The contract further specifies that AstraZeneca must make every effort to produce the vaccine at manufacturing sites located within the EU and will be able to manufacture the vaccine in non-community facilities limited to those located only in the UK to accelerate the supply of vaccines in Europe. The possibility of using production sites outside the EU must, according to the contract, be preceded by a written notification that includes an explanation of this decision.

Do other countries have priority?

According to von der Leyen, the contract does not foresee the possibility of AstraZeneca slowing down production for the EU due to contracts signed with other countries – for example with Great Britain. (The contract between the UK and AstraZeneca was not disclosed.)

In the contract, AstraZeneca declares, guarantees and accepts that it is not subject to any obligation (…) that conflicts or is materially inconsistent with the conditions of this contract or that may prevent the full performance of the obligations under this contract.

EMA approval

The AstraZeneca vaccine currently in use in Britain and the go-ahead from EMA, the European Medicines Authority, is expected. After the approval of this product, the EU, like Great Britain, will have three vaccines against Covid.

According to the advances, Ema should guarantee approval for all age groups, but Aifa, the Italian regulatory body, could limit its use only to people under 65.

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