The European Commission will tighten the criteria to authorise the export of EU-made coronavirus vaccines in a bid to secure supplies for citizens inside the bloc.
The move follows weeks of shortages and delays, especially related to Anglo-Swedish company AstraZeneca, which has caused great frustration across the continent.
Brussels plans to incorporate the principles of "proportionality and reciprocity" into the transparency mechanism that was introduced at the end of January and will assess "case by case" the export requests from pharmaceutical companies.
This means vaccination-leading countries like the UK could face a harder task getting vaccines from EU countries.
What does the EU mean by 'proportionality and reciprocity'
Proportionality refers to a country's health situation, as well as its vaccination rate and availability of doses. If a company intends to export EU-made doses to a country whose vaccination campaign is far ahead of the bloc, like Britain or Israel, the request could be refused. The same will apply to countries that have a larger stock of jabs and where the health crisis is less severe. Europe is currently going through a new wave of infections.
By reciprocity, Brussels wants to make sure that what leaves the bloc comes back - at least in some form. Reciprocal behaviour will entail that non-EU countries importing vaccines made in the bloc will, in turn, have to send to the EU other doses or, alternatively, raw ingredients needed for their production. The exchange doesn't have to be perfectly equivalent, EU officials said. Numerous countries don't have any sort of production capacity to reciprocate.
These two twin elements will be considered in addition to the potential implications that the specific export request could have on the contract between the EU and the pharmaceutical company.
The European Commission and the competent authorities from EU member states will assess the petition based on the three criteria. The Commission will then issue an opinion and the national body will decide whether or not to grant the export authorisation.
Another important update is the suspension of the exemption for countries on the fringes of the EU, which were not covered by January's proposal. The ones now subject to scrutiny are: Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Israel, Jordan, Iceland, Lebanon, Libya, Liechtenstein, Montenegro, Norway, North Macedonia, Serbia and Switzerland.
Low- and middle-income countries under the global scheme COVAX will still remain exempted from potential blockages.
The "proportionality and reciprocity" elements will apply for the six weeks following the entry into force, which is immediate. The overall transparency mechanism is set to expire at the end of June.
Presenting the new proposal on Wednesday afternoon, Commission Vice-President Valdis Dombrovskis underlined that the adjustments don't constitute an export ban and don't target any particular country or company.
Dombrovskis said that the European Union is the only vaccine producer of the OECD that is exporting to countries that have production capacities of their own, without enjoying reciprocity in return.
The vice-president explained the transparency scheme will distinguish between "poorly-performing companies" and those fulfilling their contractual obligations with the bloc. In the case of AstraZeneca, the company is "not even close" to delivering the figures it had promised, he remarked.
"We're dealing with a pandemic, we're not seeking to punish any country," added Stella Kyriakides, EU Commissioner for Health and Food Safety, who was also present in the presentation, when she was asked if the measure was directly targeting the United Kingdom, the continent's vaccination leader.
The ramifications from the updated mechanism are still unclear.
So far, only one shipment - out of a total of 380 export requests - has been blocked: 250,000 doses of AstraZeneca that were destined for Australia. Italy denied this request arguing that AstraZeneca was failing to deliver and that the health situation in Australia was not as dire as in Italy.
If this pattern continues and blockages remain minimal, global supply chains will not be affected.
However, if member states decide to use the "proportionality and reciprocity" principles to pursue a hardline approach, many third countries could see their vaccination campaigns interrupted and derailed.
Since late January, the EU has exported more than 43 million doses to 33 different locations. According to the Commission, the main export destinations include the UK (with approximately 10.9 million doses), Canada (6.6 million), Japan (5.4 million), Mexico (4.4 million), Saudi Arabia (1.5 million), Singapore (1.5 million), Chile (1.5 million), Hong Kong (1.3 million), Korea (1.0 million) and Australia (1.0 million).
Moreover, the transparency mechanism doesn't guarantee that blocked doses will be automatically re-directed towards the bloc. The EU cannot go as far as seizing the property of private companies. If an export request is denied, it will be up to that private entity to decide what to do with the doses, which could be stored or sent to another country.
Vice-President Dombrovskis admitted that the EU is not expecting a concrete number of new doses to arrive as a result of this new proposal and vowed that global supply chains will continue to function with normalcy. The objective of the mechanism, he said, was to increase transparency surrounding vaccine exports and ensure that contractual obligations are met.
The presentation of the updated mechanism comes a day before EU leaders are set to meet via videoconference in the European Council. Some countries, like Ireland, have already voiced their opposition to any kind of exports ban, while others, like France and Italy, have been more vocal in the need to control how many jabs leave the bloc.
The Commission said that it's in touch with pharmaceutical companies and third countries to explain how the adjusted scheme will work in practice.
Brussels claims that its methods are consistent with its international commitment under the World Trade Organization (WTO) and the G20. However, Ngozi Okonjo-Iweala, the WTO director-general, has already expressed her disappointment with the measure.