Member Article

Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union.

Regulation 2021/111 raises a number of important practical questions, from the point of view of administrative law – and in particular from the point of view of the procedural and litigation guarantees for private parties.

Regulation 2011/111 prohibits the exportation of vaccines against COVID-19 without the production of a valid export authorisation. This authorisation must be produced when the vaccines are declared for export and up to the time of their release¹. The justification given for this admittedly harsh measure is the fear that there may be a risk of breach of contractual commitments entered into by vaccine producers under Advance Purchase Agreements (APAs) with the European Commission². In addition, the Commission stresses the need to ensure transparency on the quantities of vaccines produced and their destination³.

Not all destination countries for the export of vaccines are covered by the prior authorisation requirement. Invok ing the “principle of international solidarity”, the Regulation excludes exports to a long list of countries and regions outside the European Union from the scope of the authorisation procedure. These countries include Iceland, Switzerland, Egypt and Ukraine ⁴. Besides these countries, low and middle-income countries on the COVAX AMC list, including most sub-Saharan African states, several of the poorest states in Latin America, and India and Indonesia, are also excluded from the authorisation requirement.

Destination countries that are not exempt from the prior authorisation requirement include several non-EU high-income countries such as the United States, Canada, New Zealand and the United Kingdom.

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