The European Union is poised to tighten rules on the export of COVID-19 vaccines, risking a major escalation in the global battle to secure access to the life-saving shots.
With EU governments under fire over the shortfall in deliveries from drugmakers including AstraZeneca Plc, the EU’s executive arm will on Friday require companies seeking to ship the inoculations outside the bloc to obtain prior authorization.
European Council President Charles Michel has also raised the prospect of effectively seizing control of vaccine production if those measures fail to get the program back on track, a European official said.
This amounts to a rapid EU escalation amid anger by the 27 member governments about the slowness of the rollout, especially in comparison to the U.K, which left the bloc and sorted its supply independently.
The EU’s export controls will oblige pharmaceutical companies to notify national authorities in advance of the amounts and destination of any vaccine shipments, European officials in Brussels said.
“Risking retaliatory measures from other regions at this crucial moment in the fight against COVID-19 is not in anyone’s best interest,” warned the European Federation of Pharmaceutical Industries and Associations.
The new rules will allow EU states to block exports if a set of predefined criteria haven’t been met, the officials said. The main condition will be that companies have already delivered a sufficient number of dosages to EU members, as set out in existing purchase agreements.
The dramatic move, which in effect imposes a “Europe first” system for vaccine deliveries, marks a step change in the EU’s struggle to reignite a vaccination campaign that got off to a sluggish start. The situation has spun out of control since AstraZeneca said last week that deliveries of shots to the continent will be slower than anticipated.
In response, the EU demanded that AstraZeneca dip into U.K. supplies to make up the shortage and a series of meetings have so far failed to resolve the standoff.
On Wednesday, Michel discussed using an emergency article of the bloc’s treaties, which would grant the EU special powers to intervene in vaccine production, in a letter sent to a group of EU leaders and released by his office. Those powers could include forcing drugmakers to share their know-how and production facilities, and even the confiscation of patent rights, according to an EU official with knowledge of the matter.
Those powers are intended to be used only as a last resort, the official added.
Governments across the continent are under increasing pressure following disruptions to the rollout of doses and extended lockdowns. On Thursday, Belgian health authorities inspected the factory at the heart of the AstraZeneca controversy, according to a person familiar with the situation. The Associated Press reported the commission requested the review as it was unhappy with the explanations for the delay.
AstraZeneca shares fell for a second day, losing 1.7%.
Meanwhile, Belgium notified the EU’s executive arm of a draft law which would allow it to limit the exports of essential medicines and active ingredients, according to people familiar with the matter. The wording of the law may open the door for curbing vaccine exports from a country where key production facilities of Pfizer Inc. and AstraZeneca are based.
That request cites the bloc’s urgency procedures, which allow crisis measures for the protection of human health, the people said. It is currently being assessed by the commission, they said.
The EU’s planned vaccines export-licensing system would mirror a European arrangement put in place for part of last year for personal-protective equipment such as masks, gloves and gowns to fight the coronavirus.
The new system for vaccines will initially last until the end of March, with the possibility for an extension. EU officials have said the main goal is to get more transparency about the market situation.
In addition to the commission proposal, Friday could also see the European Medicines Agency approve the AstraZeneca shot for use. That would bring to three the number of vaccines authorized in the bloc.
The EU has reached deals with vaccine developers for a total 2.3 billion doses for the bloc’s 27 countries. Of those, AstraZeneca accounts for 400 million doses.
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