17 October 2022 (*)

(Action for annulment – Public health – Measures introduced in the European Union in the fight against the spread of the COVID-19 pandemic– Risk assessment reports drawn up by the European Centre for Disease Prevention and Control (ECDC) – Acts not open to challenge – European Commission communication and coordinated approach published on the basis of the risk assessment reports drawn up by the ECDC – Plea of illegality – Inadmissibility)

In Case T‑55/22,

Patrick Swords,

residing in Dublin (Ireland), represented by G. Byrne, lawyer,

applicant,

European Commission,

represented by A. Szmytkowska and F. van Schaik, acting as Agents,

European Centre for Disease Prevention and Control (ECDC),

represented by R. Malacalza, M.-A. Ekström and E. Sinclair, acting as Agents,

defendants,

THE GENERAL COURT (Fourth Chamber),

composed, at the time of the deliberations, of S. Gervasoni, President, P. Nihoul (Rapporteur) and J. Martín y Pérez de Nanclares, Judges,

Registrar: E. Coulon,

having regard to the written part of the procedure, in particular:

–the pleas of inadmissibility raised by the ECDC and the Commission by documents lodged at the Court Registry on 20 and 26 April 2022, respectively,

–the applicant’s observations on the pleas of inadmissibility lodged at the Court Registry on 19 June 2022,

makes the following

1By his action under Article 263 TFEU, the applicant, Mr Patrick Swords, seeks annulment of the risk assessment reports drawn up by the European Centre for Disease Prevention and Control (ECDC) in the context of the COVID-19 pandemic on 24 and 26 November and on 2 and 15 December 2021 (‘the contested scientific opinions’) and also the inapplicability, under Article 277 TFEU, of the Communication from the European Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, of 1 December 2021, entitled, ‘Addressing together current and new COVID-19 challenges’ (COM/2021/764 final) (‘the COVID-19 communication’) and the coordinated approach, as accepted by the Health Security Committee (HSC), published by the Commission on 8 December 2021 (‘the coordinated approach’), which were based on the contested scientific opinions.

Background to the dispute

2The applicant is an EU citizen who is habitually resident in Ireland.

3The ECDC is an EU agency empowered, under Article 7(1) of Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European centre for disease prevention and control (OJ 2004 L 142, p. 11), to give scientific opinions in respect of any matter within its mission. Under Article 3(1) of that regulation, the ECDC has, inter alia, the mission to identify, assess and communicate to the European Commission, the European Parliament and the Member States current and emerging threats to human health from communicable diseases.

4Thus, in the context of the COVID-19 pandemic and the rapid spread of the Delta and Omicron variants of the virus responsible for that pandemic, the ECDC issued the contested scientific opinions on 24 and 26 November and on 2 and 15 December 2021.

5In the contested scientific opinions, the ECDC considered that the risk of transmission of the Delta and Omicron variants of the virus responsible for COVID-19 was significant due to the proximity of the end-of-year holidays and, as regards, in particular, the Omicron variant, found that its effects on health were still uncertain. In those circumstances, the ECDC recommended the adoption of precautionary measures to reduce, as far as possible, the virus transmission rate while increasing the effectiveness of the population vaccination campaigns.

6On 1 December 2021, having received those opinions, the Commission adopted the COVID-19 communication. In addition, on 8 December 2021, it published the coordinated approach. In those documents, it invited the Member States to act swiftly and in a coordinated manner in order to reduce and slow down transmission of the virus and manage the risk of any mutations.

Forms of order sought

7The applicant claims that the Court should:

–annul several or all of the contested scientific opinions;

–declare inapplicable, pursuant to Article 277 TFEU, the COVID-19 communication and the coordinated approach;

–order, by way of a measure of inquiry, on the basis of Article 91(e) of the Rules of Procedure of the General Court, an expert’s report concerning the contested scientific opinions;

–order each of the defendants or either of them to pay the costs.

8The Commission contends that the Court should:

–declare the action inadmissible;

–in the alternative, grant it a further period for submitting in writing its forms of order sought and arguments of fact and law, in accordance with Article 130(8) of the Rules of Procedure;

–order the applicant to pay the costs incurred by the Commission.

9The ECDC contends that the Court should:

–declare the action inadmissible;

–order the applicant to pay the costs incurred by the ECDC.

Law

10Under Article 130(1) and (7) of the Rules of Procedure, if the defendant so requests, the Court may give a ruling on inadmissibility or lack of competence without going to the substance of the case. In the present case, since the Commission and the ECDC have applied for a ruling on inadmissibility, the Court, considering that it has sufficient information from the documents in the file, has decided to rule on that application without taking further steps in the proceedings.

The application for annulment of the contested scientific opinions

11The applicant seeks the annulment of the contested scientific opinions on the ground that they had a decisive impact on the adoption by the Commission and the Member States, in the context of the COVID-19 pandemic, of measures restricting his fundamental rights and freedoms, including his right to freedom of movement within the European Union, his right to earn a livelihood, his right to personal integrity, his right to privacy, his right to dignity and his right not to be discriminated against.

12The Commission and the ECDC contend that that application is inadmissible, in particular, because, in their view, the contested scientific opinions are not challengeable acts for the purposes of the first paragraph of Article 263 TFEU.

13In that regard, it must be held that, under the first paragraph of Article 263 TFEU, the Court is to review the legality of acts of bodies, offices or agencies of the Union intended to produce legal effects vis-à-vis third parties.

14It is settled case-law that:

–any measures adopted by the institutions, whatever their form, which are intended to have binding legal effects capable of affecting the interests of the applicant by bringing about a distinct change in his legal position are regarded as challengeable acts for the purposes of the first paragraph of Article 263 TFEU (judgments of 11 November 1981, IBM v Commission, 60/81, EU:C:1981:264, paragraph 9, and of 12 September 2006, Reynolds Tobacco and Others v Commission, C‑131/03 P, EU:C:2006:541, paragraph 54);

–in the case of acts or decisions adopted by a procedure involving several stages, an act is open to review only if it is a measure definitively laying down the position of the institution on the conclusion of that procedure, and not a provisional measure intended to pave the way for the final decision (judgment of 11 November 1981, IBM v Commission, 60/81, EU:C:1981:264, paragraph 10).

15It is also apparent from the case-law that the opinions delivered by an EU agency in order to provide an EU institution with scientific information, with a view to the adoption of a decision by that institution, are preparatory acts. Consequently, those scientific opinions are not considered to be challengeable acts within the meaning of the case-law referred to in paragraph 14 above (see, to that effect, judgments of 22 January 2015, Teva Pharma and Teva Pharmaceuticals Europe v EMA, T‑140/12, EU:T:2015:41, paragraph 53; of 14 December 2018, Arysta LifeScience Netherlands v EFSA, T‑725/15, EU:T:2018:977, paragraph 90; and of 19 December 2019, Vanda Pharmaceuticals v Commission, T‑211/18, EU:T:2019:892, paragraph 30).

16According to recital 5 of Regulation No 851/2004, the ECDC was set up, as an independent agency, in order to serve as a source, at EU level, of independent scientific advice, assistance and expertise. To that effect, it has the mission, in accordance with Article 3(1) of that regulation, of identifying, assessing and communicating current and emerging threats to human health from communicable diseases. From that point of view, it was provided, inter alia, as is apparent from Article 3(2)(b) of that regulation, that the ECDC is to provide scientific opinions and scientific and technical assistance including training.

17Regulation No 851/2004, as provided in recital 6 thereof, does not confer any regulatory power on the ECDC.

18Lastly, it must be pointed out that, according to the last paragraph of Article 288 TFEU, opinions are not binding.

19In those circumstances, it cannot be maintained, in the present case, that the contested scientific opinions produce binding legal effects. In the context of the COVID-19 pandemic, they have no other purpose than to help Member States, in particular, to prepare and react to the rapid development of the Delta and Omicron variants of the virus responsible for the pandemic by providing them with information which they will be able to take into account during the consultation referred to in Article 11(1) of Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ 2013 L 293, p. 1).

20Article 11(1) of Decision No 1082/2013 provides that, following a public health alert, the Member States, on a request from the Commission or another Member State and on the basis of available information, including the risk assessment provided by the ECDC, are to consult each other, within the HSC and in liaison with the Commission, with a view to coordinating their responses to the emergence or development of a serious cross-border threat to public health.

21It follows that the Member States are free to take the contested scientific opinions into account in order better to prepare, from a scientific point of view, their reaction to the Delta and Omicron variants of COVID-19, without being in any way bound by those opinions.

22That interpretation is confirmed by the insertion, in the contested scientific opinions, of a disclaimer in favour of the ECDC, which is worded as follows:

‘The ECDC issues this risk assessment document based on an internal decision and in accordance with Article 10 of Decision No 1082/2013 and Article 7(1) of [Regulation No 851/2004]. In the framework of ECDC’s mandate, the specific purpose of an ECDC risk assessment is to present different options on a certain matter. The responsibility on the choice of which option to pursue and which actions to take, including the adoption of mandatory rules or guidelines, lies exclusively with the EU/EEA countries. In its activities, ECDC strives to ensure its independence, high scientific quality, transparency and effectiveness.’

23It follows from the foregoing that the contested scientific opinions do not have binding legal effects and cannot therefore be regarded as challengeable acts for the purposes of the fourth paragraph of Article 263 TFEU.

24Accordingly, the application for annulment of the contested scientific opinions must be held to be inadmissible.

The plea of illegality directed against the COVID-19 communication and against the coordinated approach

25In so far as is necessary, it should be noted that, in his action, the applicant also asks the Court to declare, by way of a plea of illegality, on the basis of Article 277 TFEU, the inapplicability, first, of the COVID-19 communication and, secondly, of the coordinated approach, on the ground that those documents are based on the contested scientific opinions, which contain, on the risks examined, manifestly inappropriate and grossly misleading assessments.

26However, there is no need to examine whether that plea of illegality is well founded in the context of the present action for two reasons.

27In the first place, a plea of illegality must be analysed in accordance with the case-law as a plea put forward in support of an application concerning one or more other acts in an action for annulment (see, to that effect, judgment of 15 June 2017, Kiselev v Council, T‑262/15, EU:T:2017:392); since it is a plea in law, it does not have to be examined where, as in the present case, the action in which it is raised is declared inadmissible.

28In the second place, a plea of illegality gives a party the right to challenge, in order to obtain the annulment of an act of direct and individual concern to that party, the validity of acts of the institutions which, having been adopted previously, constitute the legal basis of the contested act, where that party did not have the right to bring a direct action under Article 263 TFEU against those acts (see, to that effect, judgments of 6 March 1979, Simmenthal v Commission, 92/78, EU:C:1979:53, paragraph 39, and of 19 January 1984, Andersen and Others v Parliament, 262/80, EU:C:1984:18, paragraph 6).

29That is not the situation in the present case because the documents called into question in the plea of illegality, namely the COVID-19 communication and the coordinated approach, were adopted subsequently and not prior to the contested scientific opinions referred to in the action. As those documents were adopted subsequently they did not serve as a legal basis for the contested scientific opinions, but, on the contrary, were drawn up, subsequently, taking into consideration the factors which were set out therein.

30For those reasons, the action must be dismissed as inadmissible without it being necessary, first, to examine whether the plea of inadmissibility is well founded and, secondly, to rule on expertise as requested by the applicant in the form of order sought (see paragraph 7 above) as such expertise has no bearing on the present proceedings.

Costs

31Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs, if they have been applied for in the successful party’s pleadings.

32The applicant submits that equity requires that, even if he is unsuccessful, the Court should not order him to pay the costs, given the dissuasive effect which such a decision might have on access to justice, his right to an effective judicial remedy and his personal situation.

33However, it is for the applicant to explain, specifically, how his being ordered to pay the costs could have an impact on access to justice, his right to an effective judicial remedy and his personal situation (see, to that effect and by analogy, judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 304).

34Since such an explanation has not been provided in the present case, the Court considers that there is no need to derogate from Article 134(1) of the Rules of Procedure. Accordingly, since the applicant has been unsuccessful, he must be ordered to bear his own costs and to pay those of the Commission and the ECDC, in accordance with the form of order sought by the defendants.

On those grounds,

hereby orders:

1.The action is dismissed as inadmissible.

2.Mr Patrick Swords shall pay the costs.

Luxembourg, 17 October 2022.

Registrar

President

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* Language of the case: English.