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Op-Ed
Sabrina Roettger-Wirtz and Mariolina Eliantonio
“Hidden’ vaccines in Italian plant: EU composite
procedures and hidden accountability paths”
www.eulawlive.com
Suggested citation: Sabrina Roettger-Wirtz and Mariolina Eliantonio, “Hidden vaccines in Italian plant: EU composite
procedures and hidden accountability paths”, EU Law Live, 5 April 2021
“Hidden’ vaccines in Italian plant: EU composite
procedures and hidden accountability paths”
Sabrina Roettger-Wirtz and Mariolina Eliantonio
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1. Introduction
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
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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
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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.
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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.
4. Conclusion
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.
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