Judgment;Summary — ECLI:EU:C:2023:566
Date: 2023-07-13
Language of the case: Italian
Court formation: Second Chamber
Subject matter: Citizenship of the Union;Right of entry and residence;Approximation of laws;Public health;Fundamental rights
Procedure: Reference for a preliminary ruling - inadmissible
Origin: Italy

Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged:  
13 December 2021 
Referring court:  
Tribunale ordinario di Padova (Italy) 
Date of the decision to refer:  
7 December 2021 
Applicant:  
D.M. 
Defendant:  
Azienda Ospedale-Università di Padova 
  
Subject matter of the main proceedings 
Action brought by D.M. against Azienda Ospedale-Università di Padova by which 
the applicant seeks reinstatement with that entity. 
Subject matter and legal basis of the request 
Article 19 TEU; Article 267 TFEU; interpretation of Article 4 of Regulation (EC) 
No 507/2006, also in the light of Articles 3 and 35 of the Charter of Fundamental 
Rights of the European Union (the ‘Charter’) (Question 1); interpretation of 
Regulation (EC) No 507/2006 (Question 2); interpretation of Regulation (EC) 
No 507/2006 and Article 41 of the Charter (Question 3); interpretation of the 
principle of proportionality (Question 4); interpretation of Article 41 of the 
Charter (Question 5); interpretation of Regulation (EU) 2021/953 (Question 6); 
interpretation of Regulation (EU) 2021/953 and the principles of proportionality 
and non-discrimination (Question 7). 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-765/21 
 
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Questions referred for a preliminary ruling 
1. Can the conditional authorisations of the Commission, issued following a 
favourable opinion of the EMA, for vaccines currently on the market be 
considered still valid for the purposes of Article 4 of Regulation No 507/2006, in 
the light of the fact that in several Member States (for example in Italy, AIFA 
(Agenzia italiana del farmaco; Italian Medicines Agency) approval of the method 
of treatment with monoclonal and/or antiviral antibodies) effective alternative 
COVID SARS 2 treatments have been approved, which, the applicant argues, are 
less hazardous for human health, and also in the light of Articles 3 and 35 of the 
Nice Charter? 
2. In the case of healthcare workers on whom the law of the Member State in 
question has imposed compulsory vaccination, can vaccines approved by the 
Commission conditionally within the meaning of Regulation No 507/2006 be used 
for the purposes of compulsory vaccination even if the healthcare workers in 
question have already been infected and thus have already acquired natural 
immunity and can therefore apply for a derogation from the obligation? 
3. In the case of healthcare workers on whom the law of the Member State in 
question has imposed compulsory vaccination, can vaccines approved by the 
Commission conditionally within the meaning of Regulation No 507/2006 be used 
for the purposes of compulsory vaccination, without any procedure for 
precautionary purposes, or may those healthcare workers oppose inoculation, in 
view of the conditionality of the authorisation, at least until the deciding health 
authority has ruled out, in the circumstances concerned and with reasonable 
certainty, that, on the one hand, there are no contraindications to that effect and, 
on the other, that the benefits to be gained from them outweigh those gained from 
other medicinal products currently available? In that case, must the deciding 
health authority act in accordance with Article 41 of the Nice Charter? 
4. In the case of a vaccine authorised conditionally by the Commission, can a 
failure by healthcare personnel to comply with the obligation under the law of the 
State to be vaccinated automatically entail suspension from work without pay or 
must provision be made for a graduated scale of penalties in accordance with the 
fundamental principle of proportionality? 
5. Where national law permits forms of dépeçage [attribution of different tasks 
to a worker], must the possibility of alternative deployment of the worker 
concerned be examined in accordance with the principle of audi alteram partem 
laid down in Article 41 of the Nice Charter, with a consequent right to 
compensation in the event of failure to do so?  
6. Is national legislation, such as that laid down in Article 4(11) of Decree-Law 
No 44/2021, which allows healthcare personnel who have been declared exempt 
from the obligation to be vaccinated to carry on their activities in contact with 
patients, albeit in compliance with the safety measures imposed by the legislation 
AZIENDA OSPEDALE-UNIVERSITÀ DI PADOVA 
 
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in force, whereas a healthcare worker who, like the applicant – being naturally 
immune following infection – does not wish to be vaccinated without thorough 
medical examinations, is automatically suspended from all professional activity 
and without pay, lawful in the light of Regulation 2021/953, which prohibits any 
discrimination between those who have taken the vaccine and those who have 
been unwilling or unable to take it for medical reasons? 
7. Is legislation of a Member State which provides for a compulsory Covid 
vaccine – conditionally authorised by the Commission – for all healthcare 
personnel, even if they come from another Member State and are in Italy for the 
purposes of exercising the freedom to provide services and freedom of 
establishment, compatible with Regulation 2021/953 and with the principles of 
proportionality and non-discrimination contained therein? 
Provisions of EU law and EU case-law relied on 
EU Treaty, in particular Article 19(3)(b). 
FEU Treaty, in particular Articles 267 and 288. 
Charter of Fundamental Rights of the European Union, in particular Articles 3, 35 
and 41. 
Directive 2001/83/EC of the European Parliament and of the Council of 
6 November 2001 on the Community code relating to medicinal products for 
human use, in particular Article 1.28a thereof. 
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional 
marketing authorisation for medicinal products for human use falling within the 
scope of Regulation (EC) No 726/2004 of the European Parliament and of the 
Council, in particular Article 4. 
Regulation (EU) 2021/953 of the European Parliament and of the Council of 
14 June 2021 on a framework for the issuance, verification and acceptance of 
interoperable COVID-19 vaccination, test and recovery certificates (EU Digital 
COVID Certificate) to facilitate free movement during the COVID-19 pandemic, 
in particular recital 6. 
Judgments of the Court of Justice of the European Union in Cases 106/77; 314/85; 
C-143/88 and C-92/89; C-342/17; and C-573/17. 
Provisions of national law relied on 
Legge 24 dicembre 2012, n. 234, Norme generali sulla partecipazione dell’Italia 
alla formazione e all’attuazione della normativa e delle politiche dell’Unione 
europea (Law No 234 of 24 December 2012 on the general rules on the 
participation of Italy in the development and implementation of the legislation and 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-765/21 
 
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policies of the European Union), in particular Article 53, which prohibits the 
application of national rules or practices which discriminate against Italian 
nationals in comparison with the treatment accorded to Union citizens under 
Italian law. 
Decreto-legge 17 marzo 2020, n. 18, Misure di potenziamento del Servizio 
sanitario nazionale e di sostegno economico per famiglie, lavoratori e imprese 
connesse all’emergenza epidemiologica da COVID-19 (Decree-Law No 18 of 
17 March 2020 on measures to strengthen the National Health Service and provide 
economic assistance to families, workers and undertakings in connection with the 
COVID-19 health crisis) (converted and amended by Law No 27 of 24 April 
2020), in particular Article 26(2) and (2-bis). Those paragraphs concern 
vulnerable workers, that is to say, workers with serious health conditions, and 
provide that, for a period of time including 2021, such workers are to engage in 
smart working (paragraph 2-bis) or, where this is not possible, be absent from 
work and treated in the same way as workers absent because of illness 
(paragraph 2). 
In this regard, it should be recalled that Law No 178 of 30 December 2020, as 
amended by Decree-Law No 111 of 6 August 2021, converted and amended by 
Law No 133 of 24 September 2021, stipulated (in Article 1(481)) that the 
provisions of Article 26(2) and (2-bis) of Decree-Law No 18/2020 were to apply 
from 1 January 2021 to 31 December 2021. 
Legge 30 dicembre 2020, n. 178, Bilancio di previsione dello Stato per l’anno 
finanziario 2021 e bilancio pluriennale per il triennio 2021-2023 (Law No 178 of 
30 December 2020 on the estimated State budget for the financial year 2021 and 
the multiannual budget for the three-year period 2021-2023), in particular 
Article 1(457), under which the Minister for Health is to adopt the national 
strategic plan for vaccines for the prevention of infections with SARS-CoV-2, that 
is to say, Covid. That plan seeks to ensure the highest possible uptake of vaccines 
in the country. 
Decreto-legge 1 aprile 2021, n. 44, Misure urgenti per il contenimento 
dell’epidemia da COVID-19, in materia di vaccinazioni anti SARS-CoV-2, di 
giustizia e di concorsi pubblici (Decree-Law No 44 of 1 April 2021 on urgent 
measures to contain the COVID-19 epidemic, concerning SARS-CoV-2 
infections, justice and public competitions) (converted and amended by Law 
No 76 of 28 May 2021), in particular the first and second paragraphs, and the 
sixth to eleventh paragraphs, of Article 4. The version referred to in the order 
corresponds to that prior to the amendments incorporated by Decreto-legge 26 
novembre 2021, n. 172, Misure urgenti per il contenimento dell’epidemia da 
COVID-19 e per lo svolgimento in sicurezza delle attività economiche e sociali 
(Decree-Law No 172 of 26 November 2021 on urgent measures to contain the 
COVID-19 epidemic and for the safe performance of economic and social 
activities) (converted and amended by Law No 3 of 21 January 2022). 
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Under the first paragraph, in order to protect public health and ensure the safety of 
health services, healthcare workers are obliged to be vaccinated against Covid. 
That vaccination constitutes a fundamental requirement for the performance of 
work and professional activities by those healthcare workers. 
Under the second paragraph, the obligation to be vaccinated against Covid may be 
waived or postponed only in cases where it is established that there is a danger to 
the health of the person concerned. 
Under the sixth paragraph, the competent health authority is to determine whether 
a healthcare worker has failed to comply with the obligation to be vaccinated and 
inform his or her employer and the professional association to which he or she 
belongs. Such a determination entails suspension of the healthcare worker from 
the performance of activities, either in an employment relationship or in the 
exercise of a profession, which involve contact with other persons or entail the 
risk of Covid infection. 
Under the seventh paragraph, that suspension is to be notified to the person 
concerned by the professional association to which the healthcare worker belongs. 
Under the eighth paragraph, after being informed that a healthcare worker has 
failed to comply with the obligation to be vaccinated, the employer is to assign 
him or her tasks with no risk of infection, even if they are lower than the grade 
which he or she holds: in that case, the pay is to correspond to the new tasks 
which he or she performs. If it is not possible to assign him or her tasks with no 
risk of infection, the healthcare worker is to be suspended from work without pay. 
Under the ninth paragraph, the suspension provided for in the sixth paragraph is to 
remain in effect until the person concerned has been vaccinated or, in the absence 
of such vaccination, until the completion of the national vaccination and in any 
event no later than 31 December 2021. 
Under the tenth paragraph, without prejudice to the provisions on vulnerable 
workers laid down in Article 26(2) and (2 bis) of Decree-Law No 18/2020, in the 
event of vaccine waiver or postponement provided for in Article 4 of Decree-Law 
No 44/2021, the employer is to assign the healthcare workers concerned tasks, 
including different tasks, with no reduction in pay, so as to avoid the risk of 
infection. 
Under the eleventh paragraph, the healthcare workers concerned by the vaccine 
waiver or postponement under the abovementioned second paragraph of Article 4 
may exercise their profession, on condition that they adopt certain preventive 
measures. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-765/21 
 
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Succinct presentation of the facts and procedure in the main proceedings 
1 D.M. has been employed by the Azienda Ospedale-Università di Padova since 
2017. By decision of 16 September 2021, that entity informed her that she was 
being immediately suspended from work without pay pursuant to Article 4 of 
Decree-Law No 44/2021 on the ground that she had failed to comply with the 
obligation to be vaccinated and could not be assigned to tasks with no risk of 
infection. The suspension was to remain in effect until vaccination or, in the 
absence of such vaccination, until the completion of the national vaccination plan 
and in any event no later than 31 December 2021. D.M. brought an action seeking 
reinstatement both on the ground that she had no other income from work and that 
the suspension prevented her from carrying on other activities in the healthcare 
sector, not only in an employment relationship but also in the exercise of a 
profession. The Azienda Ospedale-Università di Padova disputed the substance of 
the action. 
The essential arguments of the parties to the main proceedings 
2 The applicant claims that she was unlawfully suspended from work. According to 
the order in question, the applicant put forward arguments of both a medical and a 
legal nature, including the fact that she has natural immunity against Covid since 
she has already been infected and had recovered. The order states that the 
defendant disputes the substance of the action. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
3 The referring court states that the conditional marketing authorisations for Covid 
vaccines under Regulation (EC) No 507/2006 are acts of EU law and therefore 
their lawfulness can be examined only by the Court of Justice, without prejudice 
to the possibility, for the referring court, to carry out, on a precautionary basis, an 
evaluation of the validity of an act of EU law, with an obligation to make an 
immediate reference to the Court of Justice. 
4 In the view of the referring court, the availability of new treatments and new 
medicinal products calls into question the validity of the conditional authorisations 
issued under Article 4 of Regulation (EC) No 507/2006, given that those 
authorisations concern physical integrity and health, as protected by Articles 3 and 
35 of the Charter. 
5 The referring court notes that, although the parties to the proceedings have not 
relied on Regulation (EU) 2021/953, that regulation is relevant to the dispute in 
question since it states that the restrictions on freedom of movement of persons 
relating to the Covid pandemic must be applied in accordance with the general 
EU-law principles of proportionality and non-discrimination. 
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6 In that regard, the referring court points out that Article 4 of Decree-Law 
No 44/2021 may have discriminatory effects and may give rise to problems of 
interpretation and application. In particular, according to the order in question, on 
the one hand a healthcare worker who is unable to be vaccinated may continue his 
or her work or profession in the healthcare sector, provided that certain safety 
rules are complied with; on the other hand, a healthcare worker who refuses to be 
vaccinated may not carry on any health activity, even if he or she is willing to 
follow those safety rules. 
7 The referring court goes on to recall Article 53 of Law No 234/2012, which 
prohibits the application to Italian nationals of domestic legal rules or practices 
which are discriminatory in comparison with the treatment accorded to EU 
citizens under Italian law. In those circumstances, that court is uncertain whether 
there is compliance with the principle of proportionality laid down in Regulation 
(EU) 2021/953 in a case where Italy imposes a vaccination obligation on a 
healthcare worker from another Member State who is present in Italian territory 
for purposes of work.