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The European Commission has today (24 March) adopted a revision of its export, transparency and authorization mechanism for vaccines. The new mechanism will add an assessment of reciprocity and proportionality to its existing mechanism.
On reciprocity, the Commission will assess whether destination countries are failing to export vaccines and other raw materials essential to vaccine production, either through an actula export ban or measures that are equivalent to a ban.
The inclusion of materials in the supply chain means that the US would meet this requirement, as the US has exported drug substance to the EU. The assessment is likely to encompass the UK which does not have an export ban, but has not exported to the EU, despite having received almost 11 million vaccine doses from EU-based facilities.
The proportionality test will look at the scale of the epidemic in the destination country, the level of vaccination and access to vaccines. A senior official said that the Commission would take an overall view and would not be setting thresholds, such as the percentage of the population that had already been vaccinated.
Again the UK, which has a much higher rate of vaccination than the EU, would probably be considered to have failed this test of proportionality.
A UK spokesperson said: “We are all fighting the same pandemic – vaccines are an international operation; they are produced in collaboration by great scientists around the world. And we will continue to work with our European partners to deliver the vaccine rollout.
“We remain confident in our supplies and are on track to offer first doses to all over 50s by April 15th and all adults by the end of July. Our plan to cautiously reopen society via our road map also remains unchanged.”
A Commission official confirmed that the EU was in constant contact with the UK. The UK side described the talks as being very intense and that there may be a breakthrough this evening.
UPDATE 18:48 :
Asked if the Commission would block the export of Pfizer vaccines to the UK if the UK doesn’t send vaccines to the EU, the Commission said that decisions would be taken on a case-by-case basis – without confirming or denying that this would be their approach.
The mechanism has also been extended to 17 additional neighbouring countries*, because of what a senior Commission official described as the risk of circumvention.
Yesterday (23 March), following the General Affairs Council, Commission Vice President Maroš Šefčovič told journalists: “I’m sure that by now all of you know that AstraZeneca (AZ) continues to under-deliver,” but added: “We are not seeking an outright ban on vaccines export, but we expect manufacturers to live up to their contractual obligations.”
Šefčovič underlined: “Europe is one of the most open regions exporting COVID-19 vaccines, but we see that there are many restrictions for the vaccines coming to Europe. We therefore, want reciprocity and proportionality. The export authorization mechanism is enabling us for the very first time to have full transparency about what is supposed to be exported, in what amounts and to what country.”
In an exchange between the Director General of DG Sante Sandra Gallina and the European Parliament’s Budgetary Control committee, Gallina said that while Pfizer and Moderna had been delivering, with small glitches, AZ had been the problem. She said that the Commission had been discussing solutions with member states and would be taking further action, saying: “We will use all the tools at our disposal to get the doses.” She underlined that there was no problem with the other companies exporting as they had fulfilled their commitments under the Advanced Purchase Agreements they had reached with the EU.
In an answer to a question from Tomáš Zdechovsky MEP (EPP, CZ), who said that he was sick of AZ’s “dirty tricks”, Gallina said that she shared his frustrations with the company. AZ had established a plan of production with the EU and were under an obligation to produce before authorization was granted and therefore to have had the doses ready for rapid rollout: “It’s now producing with one plant of the five plants that were included in the contract, as the plant with which they have to supply the European market…It’s not in a very good position to defend itself.”
*List of countries included: Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Israel, Jordan, Iceland, Lebanon, Libya, Liechtenstein, Montenegro, Norway, North Macedonia, Serbia and Switzerland.
Background
The Commission has so far signed Advance Purchase Agreements (APAs) with six companies (AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac, and Moderna), securing access to up to 2.6 billion doses. Negotiations are advanced with two additional companies.
The APAs finance the upfront costs faced by vaccines producers and is considered as a down-payment on the vaccines that are actually purchased by member states. It reduces the risk for a company allowing investment for the company to pre-produce, even before a vaccine is granted marketing authorization by the European Medicines Agency. The aim is to achieve a steady delivery as soon as the authorization has been granted.
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