# C_2022138EN.01000801.xml

| 28.3.2022 | EN | Official Journal of the European Union | C 138/8 |
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28.3.2022

EN

Official Journal of the European Union

C 138/8

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Request for a preliminary ruling from the Tribunale ordinario di Padova (Italy) lodged on 13 December 2021 — D.M. v Azienda Ospedale-Università di Padova

(Case C-765/21)

(2022/C 138/08)

Language of the case: Italian

Referring court

Tribunale ordinario di Padova

Parties to the main proceedings

Applicant: D.M.

Defendant: Azienda Ospedale-Università di Padova

Questions referred

| 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, (1) 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? |
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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, (1) 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? |
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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? |
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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? |
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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? |
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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 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, (2) 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? |
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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 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, (2) 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? |
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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?

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(1)  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 (OJ 2006 L 92, p. 6).

(2)  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 (OJ 2021 L 211, p. 1).

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