Judgment;Summary — ECLI:EU:C:2021:191
Date: 2021-03-10
Language of the case: Italian
Court formation: Eighth Chamber
Subject matter: Public health
Procedure: Reference for a preliminary ruling
Origin: Italy

Anonymised version 
Translation C‒96/20 ‒ 1 
Case C-96/20 
Request for a preliminary ruling 
Date lodged: 
24 February 2020 
Referring court: 
Corte suprema di cassazione (Italy) 
Date of the decision to refer: 
7 November 2019 
Appellants: 
Ordine Nazionale dei Biologi 
MX 
NY 
OZ 
Respondent: 
Presidenza del Consiglio dei Ministri 
  
ITALIAN REPUBLIC 
THE CORTE SUPREMA DI CASSAZIONE (SUPREME COURT OF 
CASSATION) 
FIRST CIVIL DIVISION 
… [procedure] 
INTERLOCUTORYY ORDER 
in the proceedings … brought by: 
EN 
REQUEST FOR A PRELIMINARY RULING OF 7. 11. 2019 — CASE C‒96/20 
 
2  
Anonymised version 
Ordine Nazionale dei Biologi … 
‒ appellant ‒ 
v 
Presidenza del Consiglio dei Ministri … 
[Or.2] 
‒ cross-appellant ‒ 
… 
against Judgment No 3817/2015 of the CORTE D’APPELLO di ROMA (Court of 
Appeal, Rome, Italy), lodged on 19 June 2015; 
… [procedure] 
FACTS 
By summons dated 10 June 2008, the Ordine Nazionale dei Biologi (National 
Association of Biologists, Italy) and the medical biologists MX, NY, … and OZ 
brought an action before the Tribunale di Roma (District Court, Rome, Italy) 
against the Presidenza del Consiglio dei Ministri (Presidency of the Council of 
Ministers, Italy) … [as well as certain other public authorities], alleging 
infringement of the right to be appointed as the responsible person of an 
establishment providing blood transfusion services, which is granted ‒ where the 
applicant meets specific requirements regarding experience ‒ to individuals 
holding a degree in biological sciences and individuals holding a degree in 
medicine and surgery by Article 9(2) of Directive 2002/98/EC, which sets 
standards [Or.3] of quality and safety for the collection, testing, processing, 
storage and distribution of human blood and blood components. 
The applicants complained that Legislative Decree No 261 of 2007, which 
implements that directive, instead specified, in Article 6(2) thereof, that only 
individuals holding a degree in medicine and surgery may be appointed as the 
responsible person of such an establishment, thus excluding biologists from 
appointment as responsible persons, under rules which conflict with European 
Union legislation and which should be disapplied. 
The court seised … dismissed the application …; the court held … that the 
directive was not self-implementing, inasmuch as it was intended to lay down 
general rules on the institution of blood transfusion establishments, for the 
creation and operation of which national legislation was necessary. In so far as the 
application related to State liability for incorrect transposition of the directive, the 
court found that it had to be dismissed on the ground that the EU rules left the 
ORDINE NAZIONALE BIOLOGI 
 
3 
Anonymised version 
Member State free to choose between doctors and biologists, or to choose both, 
and that that discretion was unfettered. 
That judgment was upheld by the Corte d’Appello di Roma (Court of Appeal, 
Rome) … by Judgment No 3817 of 19 June 2015 … [Or.4] … [repetition of the 
grounds of the judgment at first instance]. 
An appeal on a point of law against that judgment … [procedure] was brought by 
the Ordine Nazionale dei Biologi, MX, NY and OZ, which put forward two 
grounds of appeal. That appeal is challenged by the Presidenza del Consiglio, as 
cross-appellant … [procedure]. 
POINTS OF LAW 
1. By their first ground of appeal, the appellants allege infringement of Article 2909 
of the Civil Code and Article 112 of the Code of Civil Procedure. They submit 
that the appeal court erred in its construction of the application, by which they 
sought a finding establishing the right, conferred by Article 9(2) of the directive 
but not implemented by the Italian State, of biologists to be appointed as the 
‘responsible person’ of a blood establishment. 
2. By their second ground of appeal, they allege infringement of Articles 10 and 117 
of the Italian Constitution, of Article 288 TFEU, of Article 9 of Directive 
2002/98/EC and of 12 general provisions of law. They assert that, in its judgment, 
the court wrongly held that the directive was not self-implementing: Article 9(2) 
draws no distinction between individuals holding a degree in medicine and 
surgery and individuals holding a degree in biology. Individuals in both groups, 
where they have the same practical experience, are identified as being eligible for 
appointment as responsible persons of blood establishments. 
[Or.5] 
3. In its [cross-appeal] …, the Presidenza del Consiglio alleges infringement of 
Articles 112 and 276(2) of the Code of Civil Procedure, in that the court of first 
instance examined the issue of the lawfulness of Article 6(2) of Legislative Decree 
No 261 of 2007 with regard to its alleged incompatibility with European Union 
law, without any such request having been made by the applicants, which had 
merely sought a finding establishing a right which they regarded as derived 
directly from the directive. 
4. The issue of the construction of the application, on which the appellants and the 
cross-appellant take opposing views, and which must be considered first, should 
be resolved in favour of the appellants. It is clear from a direct examination of the 
legal texts, which, given the procedural nature of the issue, is quite permissible, 
that the Ordine Nazionale dei Biologi and the individual biologists, while seeking 
the disapplication of the provision of national law, at the same time argue that the 
content of the directive was not reflected when it was transposed into national law. 
That placed a category of professionals as well as individual biologists at a 
REQUEST FOR A PRELIMINARY RULING OF 7. 11. 2019 — CASE C‒96/20 
 
4  
Anonymised version 
disadvantage, inasmuch as rules were introduced that discriminated against them. 
It is therefore apparent that it is alleged (1) that the rule of EU law infringed 
(Article 9(2)) was designed to confer rights on individuals, (2) that the 
infringement was a sufficiently serious one, and (3) that there is a causal nexus 
between the breach of the obligation imposed on the Member State and the harm 
suffered by the injured party (see, in this connection, the judgments of the Court 
of Justice of 10 November 1991, Francovich, C-6/90 and C-9/90, on the 
obligation upon Member States to make good loss and damage suffered as a result 
of failure to implement Community directives, [Or.6] and of 5 March 1996, 
Brasserie du pecheur and Factortame, C-46/93 and C-48/93, on the obligation 
upon Member States to make good damage caused to individuals as a result of 
breaches of Community law). 
It should be added that, in accordance with the principles of effectiveness and 
non-discrimination, rules of European Union law must be applied in their entirety, 
even by courts acting of their own motion, and that no procedural bars can prevent 
that … [procedure]. 
5. Recitals 13 to 15 of Directive 2002/98/EC state as follows: 
‒ Member States should ensure that an appropriate mechanism for designating, 
authorising, accrediting or licensing exists to ensure that the activities of blood 
establishments are performed in accordance with the requirements of this 
directive; 
‒ Member States should organise inspection and control measures, to be carried 
out by officials representing the competent authority, to ensure the compliance of 
the blood establishment with the provisions of this directive; 
‒ Personnel directly involved in the collection, testing, processing, storage and 
distribution of blood and blood components need to be [Or.7] appropriately 
qualified and provided with timely and relevant training, without prejudice to 
existing Community legislation on the recognition of professional qualifications 
and on the protection of workers; 
‒ Article 1 of the directive states the objectives thereof as follows: ‘This directive 
lays down standards of quality and safety of human blood and of blood 
components, in order to ensure a high level of human health protection’; 
‒ Article 4 of the directive provides, inter alia, as follows: ‘1. Member States shall 
designate the competent authority or authorities responsible for implementing the 
requirements of this directive. 2. This directive shall not prevent a Member State 
from maintaining or introducing in its territory more stringent protective measures 
which comply with the provisions of the Treaty. …’; 
‒ Article 5(1) provides as follows: ‘Member States shall ensure that activities 
relating to the collection and testing of human blood and blood components, 
whatever their intended purpose, and to their preparation, storage, and distribution 
ORDINE NAZIONALE BIOLOGI 
 
5 
Anonymised version 
when intended for transfusion, are undertaken only by the blood establishments 
which have been designated, authorised, accredited or licensed by the competent 
authority for that purpose’; 
‒ Article 9(1) sets out the responsibilities of the ‘responsible person’ designated 
by the blood establishment. Article 9(2) provides that ‘The responsible person 
shall fulfil the following minimum conditions of qualification: (a) he/she shall 
possess a [Or.8] diploma, certificate or other evidence of formal qualifications in 
the field of medical or biological sciences awarded on completion of a university 
course of study or a course recognised as equivalent by the Member State 
concerned; (b) he/she shall have practical post-graduate experience in relevant 
areas for at least two years, in one or more establishments which are authorised to 
undertake activities related to collection and/or testing of human blood and blood 
components, or to their preparation, storage, and distribution’. 
6. Legislative Decree No 261 of 20 December 2007, entitled ‘Revision of Legislative 
Decree No 191 of 19 August 2005 implementing Directive 2002/98/EC setting 
standards of quality and safety for the collection, testing, processing, storage and 
distribution of human blood and blood components’: 
‒ Article 2(1)(e) defines ‘blood establishments’ as the structures and related 
organisational units, including collection units, provided for by the legislation in 
force and in accordance with regional organisational models, which are 
responsible for any aspect of the collection and testing of human blood or blood 
components, whatever their intended purpose, and their processing, storage, 
distribution and allocation, when intended for transfusion; 
‒ Article 4 provides that activities relating to the collection and testing of human 
blood and blood components, including the performance of tests for biological 
evaluation provided for by the legislation in force, whatever their intended 
purpose, and to their preparation, storage, distribution and allocation, when 
intended for transfusion, are to be undertaken only in designated [Or.9] 
establishments that have been authorised and accredited; 
‒ Article 6(1) provides that bodies which have a transfusion service must 
designate a responsible person and it lists the duties of such persons. Article 6(2) 
provides that ‘The responsible person referred to in paragraph 1 shall possess a 
university decree in medicine and surgery and shall meet the requirements laid 
down by the legislation in force for eligibility to hold a position within the 
management of a complex structure in the field of transfusion medicine.’ 
7. Under Italian law, graduates in biologists are therefore precluded from taking up 
the duties of responsible person within a blood establishment, even though, as 
mentioned above, the directive includes among the relevant qualifications for that 
purpose academic qualifications obtained ‘in the field of medical or biological 
sciences’. 
REQUEST FOR A PRELIMINARY RULING OF 7. 11. 2019 — CASE C‒96/20 
 
6  
Anonymised version 
It is … true, however, that the directive lays down minimum requirements and 
allows the Member States to maintain and introduce more stringent protective 
measures in the area. Consequently, this court is in doubt about the structure of the 
provision and is uncertain whether, by means of Article 9(2), the directive directly 
grants individuals having a degree in biological sciences as well as those having a 
degree in medical sciences (when in possession of the requisite experience, of 
course) the right to be appointed as responsible person of a blood establishment or 
whether, on the contrary, it allows the Member States the option of choosing 
between the two groups — those being the positions argued by the appellants and 
the government authority respectively. 
If it is the former, then the transposition of the EU rules [Or.10] into national law 
was incorrect, as is alleged by the biologists, who emphasise the discriminatory 
aspect — medical doctors being treated as better trained and more expert — and 
point out that their application is not merely directed at the recognition of 
qualifications, but addresses a real failure on the part of the State which, in a 
manner incompatible with EU law, denies them access to this top position. 
If it is the latter, the issue would then be the discretionary power of the State to 
select the individuals which it regards as best suited to carrying out the duty in 
question, which is not a matter open to review by the courts. 
8. Since it is not immediately clear which of those two interpretations is correct, 
even having regard to the systematic criterion applied within the rules of which 
the provision forms a part, this court considers that it must refer this issue of 
interpretation to the Court of Justice of the European Union, to which, pursuant to 
Article 267 TFEU, it therefore refers the following questions for a preliminary 
ruling: 
‘Is Article 9(2) of Directive 2002/98/EC setting standards of quality and safety for 
the collection, testing, processing, storage and distribution of human blood and 
blood components to be interpreted as meaning that, by identifying as minimum 
conditions of qualification for appointment to the position of responsible person of 
a blood establishment the possession of an academic qualification ‘in the field of 
medical or biological sciences’, it confers directly on individuals having a degree 
in either discipline the right to carry out the duties of responsible person within a 
[Or.11] blood establishment? 
Does European Union law accordingly permit national law to exclude individuals 
having a degree in biological sciences from carrying out the duties of responsible 
person within a blood establishment or preclude it from doing so?’ 
… [procedure] 
… Rome, 7 November 2019. 
…