Member Article

Brief notes on Commission Regulation 2021/111 of 29 January 2021

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.

Scope and legal nature of the procedure under Regulation 2021/111

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 release. 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 Commission. In addition, the Commission stresses the need to ensure transparency on the quantities of vaccines produced and their destination.

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.

The authorisation procedure consists of several stages. It starts with an application to the national competent authority by the company wishing to export COVID-19 vaccines (including the active substances and master and working cell banks used in the production of these vaccines) outside the European Union. The national competent authority will be the authority of the Member State where the vaccines are produced. Thenational authority should assess whether or not the volume of exports is likely to pose a threat to the performance of any APAs made between the EU and vaccine producers.

According to Recital 8 of the Regulation, “The administrative modalities for these authorisations should be left to the discretion of the Member States”. In other words, the normal systems of national administrative law will apply. If the procedure is started in Portugal, the provisions of general Portuguese administrative law, in particular those of the Portuguese Code of Administrative Procedure (“CAP”) will apply.

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