The European Union may block the export of vaccines to prevent shortages

BrusselsThe open war between the European Commission and the Anglo-Swedish pharmaceutical company AstraZeneca over the announced delay in the delivery of agreed doses by the pharmaceutical company has pushed the European Union to adopt a measure on the verge of protectionism to ensure the necessary vaccines. Brussels is proposing a control mechanism that obliges pharmaceutical companies that produce in Europe to notify their willingness to export doses and, above all, that requires prior authorisation. In practice, then, it means that a government can block the sale of vaccines outside the Union if it deems it necessary to ensure that Europe has enough vaccines. Countries such as Spain and Germany have already started to have problems with shortages, which, according to German Health Minister Jens Spahn, could last for weeks.

The European Commission plans to present the legislative proposal this Friday and, as it is an emergency mechanism, it will come into force as soon as it is adopted by the members of the EU executive. However, it only intends to keep it in force during the first quarter of the year, precisely the quarter in which AstraZeneca says it cannot meet the commitment it has signed up to. Brussels is especially careful with the language and insists on not calling it a mechanism to "block" exports, but to require the "transparency" that it considers key to ensuring compliance with the agreements and to ensure that "the money that has been invested serves to manufacture vaccines for citizens," as EU sources reiterate. "Some states are acting by restricting exports, even banning them, we have to react," European sources have said to justify the measure.

It is not a general block on all exports of vaccines, but a system that will force pharmaceutical companies that produce within European territory to send their export plans to the customs authorities of each country, which will have the power to authorise it or not after consulting with the European Commission. According to the same sources cited above, the criteria for giving the green light to export is to ensure compliance with the distribution agreements agreed with the European Union. "The most important thing is that the committed vaccines stay in Europe," says the European source, who argues that it is not about applying a philosophy of "Europe first" with vaccines but to comply with the agreements: "Companies have to honour their agreements, the question perhaps is why they concluded agreements at the same time with different jurisdictions."

It will then be up to the authorities in each state to decide whether or not to grant the licence to export, a legal option provided for in the EU's the European Union's regulation on exports, which can be activated when there is a risk of shortages of certain essential products. This mechanism was already applied in March for medical equipment during the first wave of the pandemic, when supplies of masks and respirators, for example, were in short supply.

Inspection at the Belgian plant

The measure comes in the wake of the EU executive's suspicions that while AstraZeneca claims it cannot meet the agreed delivery schedule, it has sold doses of those produced in Europe to third countries, particularly the UK. In fact, this Wednesday the Belgian authorities have inspected the plant that the company has in Seneffe at the request of the Commission to see whether or not there are "production problems" with which the company justifies the delay. They have been representatives of the Federal Agency for Medicines and Health Products, the country's regulator, as indicated by the Belgian Ministry of Health. There are no conclusions and the EU executive has refused to make any statement on the matter.

AstraZeneca's chief executive met with EU representatives for the third time on Wednesday, but the meeting was inconclusive. According to the company, two of its European plants have performance problems and so it can only deliver 25% of the committed quantities. In the United Kingdom, however, it does meet delivery schedules. The European Union, however, demands compliance with the contract because it claims that the agreement already included the production of British plants. AstraZeneca defends itself by saying that the contract signed with the British was three months earlier, but in Brussels they claim that the European pre-financing that has been granted to the company was not subject to any priority clause on a first-come, first-served basis, but involved a commitment to increase production capacities.

One of the keys to unravelling the mess or, at the very least, to being able to assess which of the two parties is quoting the signed contract correctly would be for it to come to light. After a company representative gave an interview to several media reporting on the details of the contract, Brussels has demanded in writing to AstraZeneca to make it public, but the company so far refuses to do so.

And while there is still no solution, the European Medicines Agency (EMA) is due to rule on Friday on the Oxford vaccine. In addition, there are doubts about whether the EMA will fully or only partially authorise the solution of this laboratory because there is a lack of data on its impact on people over 65 years, one of the most vulnerable groups and first on the ladder of priority groups to receive the vaccine. Just this Thursday, the German vaccination committee has decided to ban the application of AstraZeneca's vaccine to the elderly, in line with the doubts expressed by the EMA earlier this week.