Op-Ed: “‘Hidden’ vaccines in Italian plant: EU composite procedures and hidden accountability paths” by Sabrina Roettger-Wirtz and Mariolina Eliantonio
On Wednesday the 24th of March, the Italian newspaper La Stampa reported on the discovery of 30 million doses of the AstraZeneca COVID-19 vaccine in a production plant in Italy. This discovery was not coincidental, as reported by Politico, since the Internal Market Commissioner Thierry Breton, after an inspection of a Dutch manufacturing site, had set out to explore where the doses produced there were distributed to, uncovering a supply to the filling site in Agnani, Italy. According to Politico, the Commission contacted Prime Minister Draghi, who asked the Health Ministry to carry out an inspection of the site, supported by Italian military police. This was not the first inspection at an AstraZeneca plant requested by the Commission.
While it was first reported that the doses were originally destined for export to the UK and later kept in the plant due to export restrictions and to stockpile them for export as soon as restrictions would be lifted, this was denied by AstraZeneca. When the news broke, it added fuel to the already heated debate about vaccine export restrictions.
How the story is unfolding also highlights – once more – the perils of finding the correct accountability forum in cases of so-called composite administrative procedures. These are decision-making processes which entail the input of administrative actors from different jurisdictions, where the final decision is issued by a Member State or an EU authority, based on procedures involving the more or less formalised input of the various participating authorities. Such procedures are used in virtually all EU policy fields, including the management of the pandemic with the respect to export licences for medical devices.
2. Legal basis of the inspection powers
Inspections of pharmaceutical production sites are not uncommon. In fact, they are an integral part of the EU’s pharmaceutical policy, for example to confirm that companies are adhering to the Good Manufacturing Practice (GMP) for medicines.
Article 111 of Directive 2001/83 (the Community Code relating to medicinal products for human use) requires the Member States to enforce pharmaceutical legislation by means of inspections, which are to be carried out unannounced if necessary, while information on both planned and performed inspections are to be shared with the European Medicines Agency. In terms of reasons for inspections, the provision leaves a relatively broad remit, referring to inspections that ‘ensure that the legal requirements governing medicinal products are complied with’ and ‘inspections shall include but not be limited to the ones mentioned in paragraphs 1a to 1f’. The article in paragraph 1(c) foresees that inspections can be carried out on the basis of a request by ‘a Member State, the Commission or the Agency.’
However, from the reported chain of events, it does not seem that the doses were uncovered during a normal inspection (for example to review compliance with the Good Manufacturing Practice), but rather that the inspection was triggered by the suspicion that doses would be hidden in the factory. No information has been publicly released on the legal basis upon which the inspections were carried out. However, it seems that they rest on a combination of the ‘general’ inspection power granted to AIFA (Agenzia Italiana del Farmaco – the Italian pharmaceutical authority) and the specific provision to this end contained in Implementing Regulation 2021/111.
The general inspection powers of AIFA are contained in the Legislative Decree of 24 April 2006, n. 219, which is the act through which Directive 2001/83 and Directive 2003/94 have been transposed in the Italian legal system. Article 53(1) of the Legislative Decree of 24 April 2006, n. 219, provides that ‘AIFA may proceed, at any point, and also without prior warning […] to inspections on the premises where activities of production, control and storage of medicines and active substances used as raw materials for the production of medicines are carried out’. Furthermore, the fourth paragraph of the same article, provides that ‘such inspections may also be carried out upon request of the Commission, the EMA or another Member State’. Similar provisions also exist in other Member States, like the German Arzneimittelgesetz (§64 (3) (c)).
In relation to the specific purpose of the inspection, the framework is given by Implementing Regulation 2021/111, which sets out a system of export authorisation whenever producers of COVID-19 vaccines wish to export their jabs out of the EU. In order to receive the authorisation, producers need to communicate ‘the volume of exports of COVID-19 vaccines, the final destination and final recipients and a precise description of the products’. According to Article 2(8) of Implementing Regulation 2021/111, the competent Member States’ authorities may verify the information submitted on the premises of the applicant.
3. The quest for accountability
While composite procedures are widely used in the EU, they often create problems with regard to political and judicial accountability, because the final decision is preceded by preparatory steps carried out by actors at various levels of governance, for which often no clear accountability fora are established. Such accountability gaps have been highlighted in the authorisation of medicines, as well as the enforcement of EU pharmaceutical law.
In the case of the procedure at hand, while the inspection was carried out by the Italian authorities, the latter acted upon the request of the European Commission. But to what extent can the Commission be held accountable for requesting that inspection? To what extent are the rights of the companies protected in this procedure?
The accountability question is especially relevant as inspections are quite an intrusive form of enforcement, as this case shows, where apparently the Italian military police entered and searched the premises. Moreover, as became clear from the discussion above, the legal mandate for pharmaceutical inspections is very wide on both EU and national levels, with inspections generally being foreseen to ensure compliance with EU pharmaceutical law in a very broad sense. However, regardless of the breadth of scope granted by EU legislation, it is beyond doubt that inspection activities, when carried out by national and EU authorities, need to respect EU fundamental rights and general principles. Especially the inviolability of the home, as protected by Article 8 ECHR and Article 7 of the Charter, and also extending to legal persons, is relevant in this regard. Inspections have to be in accordance with the law, carried out with a legitimate aim and have to fulfil proportionality requirements, while they cannot be arbitrary or carried out with excessive means.
When looking at the legislative framework, furthermore, one notices not only the remarkable breadth of the mandate to inspect in the general legal framework, but also the conspicuous silence concerning the procedural outcome of the inspection and possible sanctions concerning the export restrictions in the Implementing Regulation. Will the national authority draft an inspection report? Will the company have a right to be heard in the process? Will there be sanctions if the inspections indeed reveal that a company is ‘hiding’ vaccines?
These uncertainties in the legislative framework can be coupled with a number of worrisome gaps in terms of judicial accountability of the composite procedure at stake. Starting from the Commission’s ‘request’ to inspect, AstraZeneca will very likely be barred from directly ( under Article 263 TFEU) challenging the fact that the inspection was requested by the Commission in the first place. First of all, it is unclear in which form the Commission requested the inspection – a phone call, an email, an official letter or another formal measure? This will hardly be challengeable as a legal measure in court. Furthermore, it is settled case law that preparatory measures – such as the request for an inspection – are not subject to review under EU law, unless they affect the legal sphere of the applicant independently of the final decision. While the inspection request might be challengeable indirectly through a preliminary question of validity under Article 267 TFEU, doubts can be expressed with respect to the scope of application of this provision. In particular, while non-binding measures can certainly be subject to a preliminary question of validity, it is more uncertain (as argued here) whether this procedure can also encompass ‘non-measures’, such as a phone call.
The conduct of the inspection activities might be challengeable before the Italian courts on the basis of Italian legislation; however, the admissibility of such an action will depend on how the inspections procedure ends and seems unlikely in the absence of a formal inspection report by the competent authorities.
In the heated debate surrounding the exports of COVID-19 vaccines, the request of the Commission towards Italy to inspect the premises certainly also has a political dimension. In this regard, the general problem that composite procedures cause is that political accountability, say of a parliament, can only be raised within its jurisdiction. In this case, it would be for the European Parliament to hold the Commission to account for the request of the inspection, while the Italian Parliament would hold the Italian Ministry of Health accountable for how the inspection was carried out. This separation might often not reflect the interconnected nature of decision-making procedure. In this case, for example, it might be difficult for the Italian Parliament to meaningfully question whether the inspection was proportionate in the first place. Yet, as opposed to many relatively technical composite procedures carried out within the EU on a day to day level which generally fall below the political radar, COVID-related procedures are subject to a high level of political attention and Commission President von der Leyen has in the past been questioned on the EU’s vaccination strategy. Additionally, the Ombudsman might prove to be a valuable accountability forum, with its ongoing series of inquiries concerning the COVID-19 response of the EU administration. Nonetheless, the sanctioning power of the EP (and the Ombudsman) seems to be limited – apart from the drastic measure of dismissing the whole Commission.
The inspection of the AstraZeneca plant in Italy upon request of the Commission shows how composite procedures in the enforcement of EU law may create gaps in the judicial and political control exercised over the EU and Member State executive in the EU’s integrated administration. Thus, while the vaccines may have been discovered, the search for accountability of the relevant public authorities continues. While this phenomenon is increasingly uncovered in the literature, it creates especially pressing issues where inspections are concerned, due to the lacuna it creates for effective judicial review and fundamental rights protection.
Dr Sabrina Röttger-Wirtz is an Assistant Professor of EU Law at the Maastricht Centre for European Law (Maastricht University), working on EU risk regulation in the fields of pharmaceuticals, foods and pesticides.
Mariolina Eliantonio is Professor of European and Comparative Administrative Law at the Maastricht Centre for European Law (Maastricht University). She carries out research on the enforcement of European law before national and European courts. She specifically investigates the concept and implications of the system of shared administration, especially from a judicial protection perspective, and she examines the role of courts in the new modes of governance (such as soft law and co-regulation) and the future of the system of judicial accountability in the European integration process.