A healthcare provider delivers a dose of the AztraZeneca vaccine in London on January 14.PAUL CHILDS / Reuters
Heavy legal artillery to guarantee the European production of vaccines against Covid-19.
The President of the European Council, Charles Michel, has asked that Article 122 of the Treaty of the European Union be used in order to impose draconian measures on pharmaceutical companies that guarantee the supply of the expected doses in each EU country.
The exceptional powers invoked could go as far as an intervention by the companies to control their vaccine production or force them to produce them in factories of other laboratories.
The European Commission preferred to settle for an export control, to prevent doses from leaving the EU.
But the Council, made up of the 27 governments of the EU, calls for much tougher measures.
Recourse to an article of the Treaty designed only for natural catastrophes and crises beyond the control of a State reveals the deep concern and anger that reigns in European capitals at the failures in the delivery of doses carried out first by Pfizer and later by AstraZeneca.
European sources point out that the exceptional powers will make it possible to impose measures on pharmaceutical companies that guarantee compliance with the contracts signed with the Commission.
Should supply failures experienced in the early stages of vaccination campaigns repeat themselves, Brussels could force pharmaceutical companies to outsource production to other companies, as Pfizer has voluntarily done with Sanofi.
The rule proposed by the Council would also make it possible to force laboratories to share their knowledge, freeing up the intellectual property of vaccines.
The measures could aggravate the diplomatic and geostratetic crisis that has begun to take place as a result of the start of the vaccination campaigns.
The EU and the United Kingdom have already had friction because AstraZeneca vaccines manufactured in the company's plants on British soil and reserved, according to Brussels, for the European market are not available just hours after the European Medicines Agency approves their utilization.
London is expected to react viciously if attempts are made to control the production and intellectual property of a company like UK-based AstraZeneca.
And Moderna, a US company, is another of the pharmaceutical companies that has developed one of the vaccines authorized and used in the EU.
European sources point out, however, that "the 27 EU government leaders have pointed out time and again that the vaccine is an essential public good".
And they point out that the EU will do whatever is necessary to make this good available as planned and as the laboratories had committed.
Michel proposes recourse to article 122 in a letter in response to the complaints issued in writing by four prime ministers (Austria, Croatia, Denmark and Greece).
The President of the Council points out that if the dialogue with the pharmaceutical companies does not solve the supply problems "I believe that all the options should be explored and make use of the legal instruments and the enforcement measures that we have at our disposal in the treaties."
From the Council it is recalled that the development of a Regulation based on Article 122 to apply the drastic measures "does not signify that it has to be used, but we want it to be available if necessary".
"Governments are asking for a reaction to an increasingly worrying situation," says a European source.
The same source assures that for the European partners the attitude of the pharmaceutical companies is intolerable and, referring to Pfizer and AstraZeneca, recalls that “one of them suddenly announced that it was suspending production in one of its plants in Europe and another that it can only dispatch the fifth part of the commitment in its previous acquisition contract with the European Commission ”.
The outrage at a fiasco that threatens the credibility of the vaccination campaigns and that endangers the investment of hundreds of millions of euros from the Community budget has led the President of the European Council to demand a much sharper legal and political response than proposed so far by the Commission.
The community body plans to approve this Friday a rule that will block the export of vaccines outside the community territory when it is considered necessary to guarantee the supply of the continent.
But the measure falls far short of what the 27 member governments of the European Council are asking for.
Brussels will foreseeably present tomorrow this new mechanism for the control of vaccine shipments to third countries with which it will be able to stop, if necessary, the export of vials, as announced this Thursday by community sources.
The objective of this “notification and authorization” instrument, of which the European Commission has advanced some details and which would be practically equivalent to an export license, will be to ensure that the vaccines committed by the advance purchase agreements with the laboratories “are they remain in the EU ”, according to the sources cited.
The measure, which will be known in more detail this Friday, coinciding with the also imminent and expected green light for the AstraZeneca vaccine by the European Medicines Agency, comes a week after the Anglo-Swedish pharmaceutical company announced by surprise a reduction "Massive", in the words of the Community Executive, of at least 75 million of the doses committed to the EU for the first four months.
"It is not true that we divert the vaccine from Europe to other countries to profit"
The European Commission plan, the final details of which are still being drafted, will oblige any company that intends to export covid vaccines to send national authorities an extra document to those that were already used regularly in international trade, in the which specifies the content of what they intend to export, when they are going to send it, what quantities are exported and who is the recipient.
The national authorities will make their corresponding verifications and will give "an authorization or a refusal" to the export of the doses in a term that is supposed to be less than 24 hours.
The national authorities will have to share the information of the games with Brussels, although the Community Executive has not yet clarified its exact role or its powers.
"We will have something to say", they have assured from the Commission, although without clarifying the exact content about who will make the final decision to accept or reject the export of the vaccines (the national government or the Community Executive) and about the specific criteria under the that the shipment may be vetoed.
"If we see that there are inconsistencies, that what should remain in the Union, according to the advance purchase agreements, is aimed at export, this would allow us to intervene," said a source familiar with the project.
The intervention would imply retaining the items and these, as advanced by the Commission, "would remain in Europe and their distribution would take place according to the plan [in the contracts]."
The announcement of the measure comes after an intense fight between Brussels and the management leadership of the AstraZeneca laboratory that has been growing throughout the week, with different meetings that would not have satisfied the Community Executive.
The verbal escalation reached its climax yesterday when the Commission claimed the doses that the Anglo-Swedish laboratory could have manufactured in any of its four European plants, including the two that are located in British territory.
The EU signed an advance purchase agreement with AstraZeneca in August to purchase 300 million doses, with an option on another 100 million.
Of these, an amount close to 100 million, according to the Commission, should have been made available to EU member states in the first quarter of this year.
On Monday of this week, given the lack of clarity on the part of the pharmaceutical company about where the doses that it would have agreed to provide to the Twenty-seven could be, the European Commissioner for Health, Stella Kyriakides, announced the implementation of a control mechanism of exports, fueling suspicions that part of the production leaving AstraZeneca's factories in EU territory (one in Belgium and one in Germany) could be being sent to third countries without the knowledge of Brussels.
Information about the coronavirus
- Here you can follow the last hour on the evolution of the pandemic
- Restrictions search engine: What can I do in my municipality?
- This is how the coronavirus curve evolves in the world
- Download the tracking application for Spain
- Guide to action against the disease