Mariolina Eliantonio, Maastricht University

1. Introduction

On 4 March 2021, Italy decided to block a shipment of the Oxford/AstraZeneca Covid-19 vaccine that was destined for Australia. This remarkable move, notably made in response to AstraZeneca’s delay in providing the agreed doses of vaccines by the set deadlines, is the first of its kind since the Union introduced rules concerning the possibilities to limit exports of vaccines outside of the EU.

Under the EU’s export scheme currently in place, companies are required to receive an explicit export authorization from national authorities where their Covid-19 jabs are produced before exporting them out of the EU. In turn, before adopting a decision on the matter, national authorities are obliged to send the draft measure to the European Commission, which may overturn the authorities’ decision.

The scheme, itself created by Commission Implementing Regulation 2021/111, formed part of Brussels’ response to “ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU”. The scheme only applies to exports from companies with whom the EU has concluded Advance Purchased Agreements and is due to expire at the end of March 2021.

The procedure created by Implementing Regulation 2021/111 is an example of a composite procedure, a regulatory mechanism present in virtually all EU policy fields. Composite procedures are decision-making processes entailing the input of administrative actors from different jurisdictions, and in which the final decision, issued by a Member State or an EU authority, is based on the more or less formalized contribution of the various participating authorities.

This integrated system of decision-making has become more and more prominent in EU administrative governance, including in the management of the Covid-19 pandemic with respect to the export of personal protective equipment. However, several questions of accountability remain open when these procedures are used.

2. The composite procedure set out in Regulation 2021/111

According to Article 2(1) of Implementing Regulation 2021/111, companies must request an export authorization in the Member State where the vaccine is manufactured. According to Article 1(4), in deciding whether to grant an export authorization under this instrument, Member States shall assess whether the volume of exports is not such that it poses a threat to the execution of the Advance Purchase Agreements the EU has concluded with vaccine manufacturers.

The – composite – procedure foreseen by the export scheme set in Article 2 of Implementing Regulation 2021/111 entails two phases. First, upon receiving a request, Member States must immediately notify the Commission of any application and, after analysis, submit their draft decision to the Commission.

Subsequently, if the Commission disagrees with this draft decision, it shall issue an opinion and the Member State shall decide on the request for authorization in accordance with the Commission’s opinion. Despite the somewhat misleading name (“opinion”) the procedure in fact foresees a binding role for the Commission, which can override the Member State’s authorities in the determination of whether to authorize the export. Notable in this procedure is also that the applicable legislation only foresees the issuance of a “formal” act by the Commission in case the latter disagrees with the assessment of the national authorities. Implementing Regulation 2021/111 is silent on the role of the Commission when the latter instead agrees with the national authorities’ assessment.

In the case of Italy’s decision to block a shipment of the Oxford/AstraZeneca Covid-19 vaccine that was destined for Australia, the Commission backed up Italy’s position and did not, therefore, seem to have issued any formal act in the procedure, although it did receive Italy’s draft decision.

The question that arises in respect of this situation, and, in general, of the regulatory structure foreseen in Implementing Regulation 2021/111 is where the responsibility for this decision lies, and whether sufficient accountability mechanisms are in place when composite procedures are used for the implementation of EU law.

3. Gibt es noch Richter in Berlin?

That composite procedures are prone to create gaps of judicial protection, because they diffuse responsibility for the final decision of the process is an issue which has been studied before, including in connection with decision-making processes related to the management of the Covid-19 pandemic.

These problems seem to have clearly presented themselves in this case. Indeed, while the procedure is formally one which starts and ends at the national level, and for which therefore national authorities are expected to take responsibility, the role of the European Commission in this matter cannot be underestimated. Especially in this case, however, where the European level agreed with the national authorities and therefore did not issue any formal measure in the procedure, the European Commission had an “easy way out” to place the responsibility on the shoulders of the national government. As reported by a media outlet, “[A]n EU source in Brussels said national authorities had the final say in such matters”. However, this position clearly downplays the role of the Commission in the procedure, which, in accordance with the procedure, while not explicitly endorsing Italy’s assessment, has silently backed it up in full.

That the European Commission bears political responsibility for the final decision of the Italian authorities did not go unnoticed in Australia, with Health Minister Greg Hunt allegedly telling reporters that the country “has raised the issue with the European Commission through multiple channels”. However, the black hole of political accountability tricked the Australian authorities into believing that the European Commission (and not the national authorities) were in the driving seat of the process, as the same Health Minister also seem “have asked the European Commission to review th[e] decision“. Yet under EU law, the Commission is not authorized to review a national decision.

If we move the analysis from the realm of political accountability to that of judicial control, the picture does not become clearer. Indeed, while the final decision can be challenged before the national (in this case Italian) competent court, it is not unthinkable that the national court would consider that Italian authorities were acting on the basis an “implicit” positive opinion of the European Commission. For this reason, being unable to rule on the validity of EU measures, the Italian court would probably deem it necessary to send a preliminary question of validity under Article 267 TFEU to the Court of Justice of the European Union.

Assuming that the Court of Justice would accept its jurisdiction on this “non-measure”, a matter which is certainly not straightforward in light of earlier case law, the national proceedings would be frozen until the Court of Justice ruled on this matter. In turn, this would cause significant delays in the resolution of the dispute, which would only be partly mitigated if the national courts would consider the adoption of interim measures. In light of the case law of the CJEU, it is unlikely that such interim measures would be issued, as the exporter would have a hard time proving that there is a serious and irreparable damage to the applicant’s legal sphere, as purely financial damage is hardly considered “irreparable” according to the Court.

4. Conclusions Italy’s decision to block a shipment of the Oxford/AstraZeneca Covid-19 vaccine that was destined for Australia is a prime example of multi-level administrative cooperation and its challenges. The composite procedure set out in Implementing Regulation 2021/111 dilutes political accountability and poses serious threats to the effectiveness of judicial control. While no easy fixes can be proposed here and even the traditional fix contained in the preliminary ruling mechanism shows its limits, the call for solutions which acknowledge the increasingly “integrated” nature of the EU system of administrative governance remain open. However, “integrating” judicial control of composite procedures, by allowing national courts to rule on the validity of the actions of EU institutions, comes with a high price tag in terms of limitation of autonomy of the EU legal system. In the 18^th century, the famous miller of Sansouci wondered whether there were judges in Berlin, having jurisdiction to rule against the abuse of power of the Prussian King Frederick II, the Great. Two centuries later, the question still stands.