The EU Vaccine Export Regulation and Its Effects on a Globalized World

The European Union has moved to provide member states with a tool for export control of vaccines, as it had also done for personal protective equipment in the first wave of Covid 19. In general, the export of products from the Union to third party countries cannot be subject to any quantitative restriction, as established by Article 1 of Regulation 2015/479 which sets out a common regime applicable to exports. However, according to Article 5 of that regulation, the Commission, in order to prevent or remedy the shortage of essential products and "where the interests of the Union require immediate action", may make the export of essential products subject to export authorization. Using this legal basis, the Commission has twice adopted temporary regulations that make the export of vaccines against COVID-19, and the active ingredients used to manufacture them, subject to the presentation of an export authorization. The authorization is issued by the member states where the vaccines and active ingredients are produced, after consultation with the EU Commission. The first regulation adopted on 30 January 2021 for a duration of six weeks was followed by a second one which came into force on 13 March and which will apply until 30 June 2021. 

The first, and to date the only, European state to deny the authorization to export vaccines to third countries was Italy, which at the beginning of March blocked a shipment of 250,000 doses for Australia. The regulation is based on the principle that authorizations should normally be granted, unless the interest of the Union is at stake. But when can the interest of the Union be damaged by the export of vaccines to third countries? The regulation and the guidelines for its application issued on 30 March established the required conditions that justify the refusal of authorization. 

First, only the exports of vaccines against COVID-19 subject to preliminary purchase agreements (APA) with the Union are subject to prior authorization. APAs are a tool with which the Commission advanced part of the initial costs incurred by vaccine manufacturers in the form of a down payment on vaccines which would then be purchased by the Member States. The APAs were signed before the vaccines obtained marketing authorization and constitute public funding for research by the European Union that has allowed the development of vaccines against Covid 19 in record time. To date, the Commission has signed APA with six multinational drug companies (AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNtech-Pfizer, CureVac and Moderna), to ensure EU citizens a supply of 2.6 billion doses of the first batches produced. 

As we know the APA system has suffered some setbacks. In particular, AstraZeneca seems to have given priority to deliveries to other states, primarily the United Kingdom, failing to comply with the binding commitment to respect delivery terms with many EU member states, including Italy. 

But the question we must ask ourselves is whether the possible blocking of exports is an effective tool and what the side effects of its use are, especially if it is applied at massive scale. There are many controversial aspects, but more reflection is especially needed on three. The first concerns the use of a tool that affects commercial relations between states to obtain the correct execution of contracts entered into with private companies and the impact in general on relations with affected states. The case of the UK is emblematic and the vaccine war with London is likely to have a much wider negative effect, given the difficult state of bilateral EU / UK relations. Second, in the European context, pharmaceutical production, and vaccines are no exception, cannot be localized in a single state and currently not even the Union with its 27 member states is self-sufficient in the production of vaccines. Vaccine supply chains involve member states and third-party states. Political use of the blocking of exports, without careful consideration of the commercial consequences, could lead to countermeasures by non-EU countries which are harmful both for the production of vaccines and other devices and medicines essential to fight Covid 19. Finally, protectionism on vaccines ends up damaging the poorest countries. In fact, although the regulation does not require authorization for the export of vaccines for humanitarian reasons and in the framework of international cooperation, it can be expected that Australia, for example, will compensate for the failure to supply the vaccine by reducing exports to other countries.   

The outcome of the "vaccine war" will be decisive for future international relations. If a more equitable and sustainable world is to emerge from this pandemic, everyone must have access to the vaccine and not just the citizens of the richest countries. 

Paola Mariani, 'The EU Market in Times of a Global State of Emergency: Internal and External Trade Barriers in the Age of Pandemics'. Legal Issues of Economic Integration 48, no. 1 (2021): 5–18.