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Document 62019CC0106

Opinion of Advocate General Bobek delivered on 6 October 2021.



ECLI identifier: ECLI:EU:C:2021:816

 OPINION OF ADVOCATE GENERAL

BOBEK

delivered on 6 October 2021 ( 1 )

Joined Cases C‑106/19 and C‑232/19

Italian Republic (C‑106/19)

Comune di Milano (C‑232/19)

v

Council of the European Union

European Parliament

(Action for annulment – Admissibility – Locus standi – Direct and individual concern – Regulation (EU) 2018/1718 amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency – Prerogatives of the European Parliament – Decision adopted by the representatives of the Member States in the margins of a Council meeting to determine the location of the seat of an agency – Absence of binding effects in the EU legal order – Discretion exercised by the European Parliament in the ordinary legislative procedure – Limits)

I. Introduction

1.

Law does not like taking chances. This is not to say that lawyers, much like members of any other profession, would not be in need of a bit of luck from time to time. That statement rather implies that what lies in the cradle of modern legal systems is (the promise of) rationality and reason. Even in instances where resorting to drawing lots may in fact produce outcomes that are both impartial and cost-efficient, we still take issue with their inherent irrationality. The reason behind this is that reaching an outcome alone is not enough. Instead, what tends to be expected as the outcome of legal decision-making today is an attributable, and thus accountable and reviewable, decision. ( 2 )

2.

Without engaging directly with the philosophical implications of decision-making by lot, ( 3 ) the Comune di Milano (Municipality of Milan, Italy) and the Italian Republic certainly take issue with the outcome of such a process in the present case: the selection by drawing lots, in the margins of a meeting of the Council of the European Union, of the city of Amsterdam (Netherlands) as the new seat of the European Medicines Agency (EMA). That selection gave rise to two sets of proceedings before this Court.

3.

First, in Joined Cases C‑59/18 and C‑182/18, the Italian Republic and the Comune di Milano respectively challenged the decision of the representatives of the Member States to locate the new seat of the EMA in Amsterdam. I address the issues raised in those cases, in particular the question whether a decision of the representatives of the Member States can be subject to an action for annulment under Article 263 TFEU, in my parallel Opinion that covers Joined Cases C‑59/18 and C‑182/18, as well as Case C‑743/19 (in which the European Parliament has challenged the decision of the representatives of the Member States to locate the seat of the European Labour Authority (ELA) in Bratislava (Slovakia)). ( 4 )

4.

Subsequently, Regulation (EU) 2018/1718 provided that the new seat of the EMA was Amsterdam (‘the contested regulation’). ( 5 ) By the present actions, directed against the Council and the Parliament, the Italian Republic and the Comune di Milano are primarily challenging the legality of that regulation.

II. Legal framework

5.

Regulation 2018/1718, adopted on 14 November 2018, and based on Articles 114 and 168(4)(c) TFEU, contains the following provisions:

‘Article 1

The following Article is inserted in Regulation (EC) No 726/2004:

“Article 71a

The Agency shall have its seat in Amsterdam, the Netherlands.

The competent authorities of the Netherlands shall take all necessary measures to ensure that the Agency is able to move to its temporary location no later than 1 January 2019 and that it is able to move to its permanent location no later than 16 November 2019.

The competent authorities of the Netherlands shall submit a written report to the European Parliament and the Council on the progress on the adaptations to the temporary premises and on the construction of the permanent building by 17 February 2019, and every three months thereafter, until the Agency has moved to its permanent location.”.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall apply from 30 March 2019.

This Regulation shall be binding in its entirety and directly applicable in all Member States.’

6.

In the course of the legislative procedure leading to the adoption of Regulation 2018/1718, the European Parliament adopted legislative resolution of 25 October 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency. ( 6 ) In that resolution the Parliament, inter alia,

‘2. Denounces the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 19 July 2012 and the Common Approach annexed to it and calls for close involvement of the European Parliament in the decision-making process on the location and relocation of agencies’ and

‘5. Regrets that the European Parliament – and ultimately the representatives of the Union’s citizens – were not fully involved in the procedure to select the new seat of the [EMA], which was eventually concluded by drawing lots, despite it being such an important decision; decisions in relation to the location of bodies and agencies need, and legally must, be taken under the ordinary legislative procedure, fully respecting the European Parliament’s prerogatives, whereby the European Parliament and the Council are equal co-legislators’.

7.

The annexes to the resolution contains the following statement of the Parliament:

‘The European Parliament regrets that its role of co-legislator has not been duly taken into account since it was not involved in the procedure leading to the selection of the new seat of the [EMA].

The European Parliament wishes to recall its prerogatives as co-legislator and insists on the full respect of the ordinary legislative procedure in relation to the location of bodies and agencies.

As the only directly elected Union institution and representative of the Union’s citizens, it is the first guarantor of the respect of the democratic principle in the Union.

The European Parliament condemns the procedure followed for the selection of the new location of the seat, which has de facto deprived the European Parliament of its prerogatives since it was not effectively involved in the process, but is now expected to simply confirm the selection made for the new location of the seat by means of the ordinary legislative procedure.

The European Parliament recalls that the Common Approach [annexed] to the Joint Statement of the European Parliament, Council and European Commission on decentralised agencies signed in 2012 is legally non-binding, as acknowledged in the Statement itself and that it was agreed without prejudice to the legislative powers of the institutions.

Therefore, the European Parliament insists that the procedure followed for the selection of a new location for the agencies will be revised and not used anymore in this form in the future.

Finally, the European Parliament wishes to recall as well that in the Inter-institutional Agreement on Better Law-Making of 13 April [2016] the three institutions committed to sincere and transparent cooperation while recalling the equality of both co-legislators as enshrined in the Treaties.’

III. Factual background

8.

The European Agency for the Evaluation of Medicinal Products was created by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. ( 7 )

9.

On 29 October 1993, the Heads of State or Government of the Member States decided by common agreement to set its seat in London (United Kingdom). ( 8 )

10.

Regulation No 2309/93 was subsequently repealed and replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. ( 9 ) By that regulation, the European Agency for the Evaluation of Medicinal Products was renamed as the EMA. The regulation did not contain any provision on the location of the seat of the EMA.

11.

On 29 March 2017, in accordance with Article 50(2) TEU, the United Kingdom notified the European Council of its intention to withdraw from the European Union.

12.

On 22 June 2017, in the margins of the European Council meeting (Article 50), the Heads of State or Government of the other 27 Member States accepted, on a proposal of the President of the European Council and of the President of the European Commission, the procedure for the relocation of the seat of the EMA and of the European Banking Authority (‘the selection rules’). ( 10 )

13.

Those rules provided that the decision on the future seat of the two agencies should be taken on the basis of a fair and transparent decision-making process with an organised call for offers based on six criteria laid down in paragraph 3 of the selection rules.

14.

It was also foreseen that, in case of a tie between the remaining offers within the third (and final) voting round, the decision would be taken by the Presidency drawing lots between the tied offers.

15.

On 20 November 2017, the offer of the Italian Republic and that of the Kingdom of the Netherlands received the same number of votes within the third round of voting. The offer of the Kingdom of the Netherlands was subsequently selected after the drawing of lots.

16.

As a result, on that same day, the representatives of the Member States selected, in the margins of the 3579th meeting of the General Affairs Council, the city of Amsterdam as the EMA’s new seat (‘the decision of the representatives of the Member States’). That decision was announced in the minutes of the Council meeting ( 11 ) and resulted in a press release. ( 12 ) It was stated that ‘the Commission will now prepare legislative proposals reflecting [the vote for adoption] under the ordinary legislative procedure with the involvement of the European Parliament. …’.

17.

On 29 November 2017, the Commission adopted a proposal for a draft regulation amending Regulation No 726/2004 as regards the location of the seat of the EMA. Its explanatory memorandum stated that the ‘Member States, in the margins of the General Affairs Council (Art. 50), selected Amsterdam, the Netherlands, as the new seat of the [EMA]’. ( 13 )

18.

As a consequence, Regulation No 726/2004 was amended by Regulation 2018/1718 to provide that ‘the Agency shall have its seat in Amsterdam, the Netherlands’. ( 14 )

19.

Subsequently, four annulment actions were introduced.

20.

First, in its action currently pending as Case C‑59/18, the Italian Government asks the Court to annul the decision of the representatives of the Member States in so far as it established that Amsterdam would be the EMA’s new seat, and, consequently, to allocate that seat to the city of Milan (Italy).

21.

Second, in Case C‑182/18, the Comune di Milano, supported by the Italian Government and the Regione Lombardia (Lombardy Region, Italy), asks the Court to annul the decision of the representatives of the Member States in so far as it established that Amsterdam would be the EMA’s new seat.

22.

On 19 November 2019, the President of the Court decided to join Cases C‑59/18 and C‑182/18 for the purposes of the oral procedure and the judgment.

23.

Third, in Case C‑106/19, the Italian Republic seeks the annulment of the contested regulation.

24.

Fourth, in Case C‑232/19, the Comune di Milano seeks the annulment of the contested regulation and the declaration that the decision of the representatives of the Member States produces no binding legal effects.

25.

On 19 December 2019, the President of the Court decided to join Cases C‑106/19 and C‑232/19 (‘the present cases’) for the purposes of the oral procedure and the judgment.

IV. Proceedings before the Court

26.

In contrast to the actions in Joined Cases C‑59/18 and C‑182/18, concerned with the legality of the decision of the representatives of the Member States, the present cases primarily give rise to the question of the legality of the contested regulation that was adopted after the decision of the representatives of the Member States.

(a)   Case C‑106/19

27.

The Italian Government requests the Court to annul the contested regulation and to order the Council and the Parliament to pay the costs related to the proceedings. The Council and the Parliament ask the Court to dismiss the action and to order the Italian Government to pay the costs related to the proceedings. The Netherlands Government and the Commission, intervening in support of the Council and the Parliament, ask the Court to dismiss the action. The Netherlands Government further asks the Court to order the Italian Government to pay the costs related to the proceedings.

28.

The action of the Italian Government invokes two grounds in support of its claim that the contested regulation is unlawful. The first ground alleges a breach of Articles 10, 13 and 14 TEU and of Articles 114, 168(4)(c), 289 and 294 TFEU. The second ground alleges that, even if it were concluded that the prerogatives of the Parliament have not been breached, the unlawfulness of the contested regulation derives from the unlawfulness of the decision of the representatives of the Member States. In this context, the Italian Government alleges a misuse of power for a lack of investigation and distortion of evidence. For a more in-depth development of the arguments raised in this context, the Italian Government refers to its action in Case C‑59/18, concerned with the lawfulness of the decision of the representatives of the Member States. ( 15 )

29.

As regards the first ground of its action, the Italian Government submits, first, that there was a breach of Article 10 TEU because the procedure followed for the selection of the new seat of the EMA did not allow European citizens to participate in that choice. In that regard, this also resulted in an infringement of Article 14(1) TEU, which states that the legislative function is exercised by the Parliament. In any case, the Commission and the Council should have made the participation of the Parliament possible. The very fact that they did not resulted in a breach of the institutional balance and the sincere and transparent cooperation expressed in Article 13 TEU. As regards Articles 289 and 294 TFEU, in conjunction with the legal basis of the contested regulation, their infringement was brought about by the fact that the ordinary legislative procedure was followed purely formally without the Parliament really being able to influence the choice of the new seat of the EMA.

30.

In its defence, the Council argues that the legislative process took place in a standard manner. The Parliament had discussed the options of the seat being located elsewhere, especially in Milan, before rejecting that option. The Parliament then submitted (and even obtained) several amendments to the proposed regulation. The Council further maintains that the competence to choose the seat of an agency belongs to the Member States acting in common agreement. It is based on Article 341 TFEU. The designation of the new seat of the EMA in the contested regulation is purely declaratory since the co-legislator could not depart from the choice made in that respect by the Member States. At the same time, however, the Parliament could (co-)define the conditions of the transfer, which it did by adding to the new Article 71a of Regulation No 726/2004 two new indents related to the deadline for the transfer, the length of the temporary location, and the obligation of the authorities of the Kingdom of the Netherlands to submit a written report to the Parliament and the Council.

31.

In its defence, the Parliament agrees with the Italian Government that the decision of the representatives of the Member States could not limit the powers of the Parliament. It is nonetheless of the view that the situation at hand did not result in the unlawfulness of the contested regulation because the Member States’ representatives do not have the competence to determine the seat of the EMA. That competence falls to the EU legislature, who cannot abstain from exercising its functions. It thus cannot purely and simply approve a previous proposition made by the Member States without exercising control over it. The decision of the representatives of the Member States was purely political, with no binding effects. The fact that the choice made in that decision was adopted in the Commission’s proposal was, in the Parliament’s view, the expression of the Commission’s discretion. When approving this choice, the Parliament likewise exercised its discretion as co-legislator.

32.

In its reply, the Italian Government emphasises the differences in the respective positions of the Council and the Parliament as regards the central issue of the competence to choose the seat of an agency. It does seem that those institutions did not know, or in any event had different views, about what competences were exercised. Due to that confusion, the Italian Government abstained from taking a position in its action on the nature of that competence, but did, however, exclude the possibility of it being part of the exclusive competences of the Member States. The Parliament’s portrayal of its involvement is formal and unacceptable. It does not show that the Parliament exercised a decisive role in the selection of the new seat of the EMA.

33.

In its rejoinder, focused on the first ground of the action, the Council states that its position, and that of the Parliament, on the matter of competence is in any case irrelevant, since both institutions agree that the prerogatives of the Parliament have been respected. The Council also notes that the exercise of the functions by an institution is reflected in the acts that it adopts. Political declarations are not determinative to assess whether the powers have been correctly exercised. The review of the lawfulness of an act cannot extend to the political reasons as to why a certain act was adopted. Furthermore, the Council reiterates that the competence to choose the seat of agencies is the exclusive competence of the Member States. The Council stresses that the competence to determine the seat of an agency is not the same as the competence to regulate a given field. It differs by its political and symbolic nature and is anchored in Article 341 TFEU.

34.

The Parliament stresses in its rejoinder that, during the legislative procedure leading to the adoption of the contested regulation, it endeavoured to protect its institutional position by all available means, while following the main objective of guaranteeing the continuity of the EMA’s activities during the transfer of its seat. Due to the Parliament’s initiative, the contested regulation is complemented with a monitoring mechanism and a timetable. Adopting a stringent position on its part within that legislative process would not have been compatible with the aim of protecting public health. The way in which the Parliament exercised its prerogatives during the legislative procedure was thus based on an advised choice and did not constitute an abdication from its role.

35.

The Netherlands Government supports, as regards the first ground of the action, the arguments developed by the Council and the Parliament.

36.

The Commission is of the view that the adoption of the decision of the representatives of the Member States could not hinder the powers of the Commission or of the co-legislators. Neither the Commission nor the Parliament are bound by the political choice of the Member States when it comes to the seat of an agency. The competence to choose the seat of an agency falls under the exclusive competence of the Union. During the discussions which led to the adoption of the contested regulation, the option of locating the new seat of the EMA in Milan was debated and excluded.

37.

As regards the second ground of the action, the Italian Government alleges, in the alternative, that, even if it were concluded that the role of the Parliament was not disregarded, the unlawfulness of the contested regulation derives from the unlawfulness of the decision of the representatives of the Member States. That decision was flawed by a misuse of powers as a consequence of the failure to investigate and by a distortion of facts. The Italian Government provides a summary of its arguments in its action in the parallel Case C‑59/18. It then outlines additional points to support its view that the offer of the Kingdom of the Netherlands did not match reality and in any case did not meet the criteria set out in the selection process.

38.

In its defence, the Council states that the legislature cannot depart from the choice made by the representatives of the Member States. Nonetheless, it still has to check whether the act at issue was adopted in compliance with the applicable rules. In this regard, the contested regulation can be subject to a judicial review. However, the legislature cannot verify the merits of the choice made, including the criteria or the process to assess the merits, or even assess the factual situation.

39.

Moreover, the Council considers that the ground relating to the misuse of powers is inadmissible and in any case unfounded because it has not been established that the decision of the representatives of the Member States was taken with the aim or purpose of achieving an end other than that genuinely pursued by the selection procedure. First, the Commission was not obliged to verify the information contained in the respective bids. Second, the alleged difference between the bid and the status quo following the selection is not relevant to conclude that the bid of the Kingdom of the Netherlands was distorted during the selection procedure. Third, in any case, it has not been demonstrated that the alleged distortion of the bid of the Kingdom of the Netherlands has led to an error of assessment of such a nature and seriousness which justifies invalidating the selection process.

40.

In its defence, the Parliament is of the view that, to the extent that the Italian Government refers to its arguments presented in another case to which the Parliament is not a party, that ground fails to meet the conditions of Article 21 of the Statute of the Court of Justice and Article 120(c) of the Rules of Procedure of the Court of Justice. On the merits, there is no procedural or other legal link between the decision of the representatives of the Member States and the contested regulation. Thus, even if it were concluded that the decision of the representatives of the Member States was flawed, that cannot affect the validity of the contested regulation.

41.

In its reply, the Italian Government states that it did not merely refer to its arguments in Case C‑59/18. It reiterates that the choice made by the Parliament was not free and, therefore, since that choice was tied to the decision made previously by the Member States, the Parliament’s prerogatives were breached.

42.

In its rejoinder, the Parliament also reiterates its position on the absence of a legal link between the decision of the representatives of the Member States and the contested regulation. Beyond the admissibility of the second ground, to which the Parliament continues to object, the Italian Government does not present arguments against the contested regulation other than those made within the first ground. The arguments raised under the second ground are thus ineffective.

43.

The Commission states that the second ground is based on the premiss that the co-legislator did nothing more than ‘certify’ the political choice. That, however, was simply not the case. Despite the complexity of its adoption and the involvement of the Commission in the process, the political decision was not binding. Therefore, it could not have pre-determined the result of the ordinary legislative procedure.

44.

The Netherlands Government states that the second ground is based on the premiss that it did not respect its commitments in its offer of 28 July 2017. The Netherlands Government points out that all facts referred to by the Italian Government actually post-date the decision of the representatives of the Member States, the lawfulness of which must be assessed against the facts existing at the moment of its adoption. In any case, the Italian Government did not show that there was an error of assessment, the nature and seriousness of which results in the decision of the representatives of the Member States being unlawful. Finally, the Netherlands Government submits that the arguments put forward by the Italian Government fail to show how the Kingdom of the Netherlands did not respect its commitments.

45.

In its reply to the interventions of the Netherlands Government and the Commission, the Italian Government draws the attention of the Court to the introduction by the Parliament of an action in Case C‑743/19 in which the Parliament challenges Decision (EU) 2019/1199 of the representatives of the Member States, taken by common accord to locate the seat of the ELA in Bratislava. ( 16 ) According to the Italian Government, the Parliament claims, in that action, that the decision at issue was adopted not by the Member States, but by the Council, and that its adoption interferes with the powers of the EU legislature. Those arguments reveal that the Parliament defends its position in the present case without conviction. In any event, the position of the Parliament is incompatible with the claim relating to the exclusive competence of the Union in this respect.

46.

In its reply to the statement in intervention submitted by the Netherlands Government, the Parliament considers that it cannot take a position on the bid of the Kingdom of the Netherlands. In its reply to the statement in intervention submitted by the Commission, the Parliament agrees that the Treaties do not reserve the competence to choose the seat of agencies to the Member States. The political importance of the decision to locate the seat of an agency cannot lead to the conclusion that the competence is that of the Member States. The Parliament also agrees that the complexity and the structure of the cooperation between the Member States, as well as the participation of the institutions in the selection process, does not confer a binding nature to the result of that cooperation.

47.

The Council, in its reply to the statement in intervention submitted by the Commission, agrees that the Parliament exercised fully its prerogatives and had significant influence over the content of the contested regulation. The Council nonetheless disagrees with the claim that the decision of the representatives of the Member States contains only a political choice with no binding legal effects.

48.

On 11 February 2019, the Italian Government requested that Case C‑106/19 be adjudicated under an expedited procedure pursuant to Article 133 of the Rules of Procedure. By decision of 15 February 2019, the President of the Court rejected that request.

(b)   Case C‑232/19

49.

The Comune di Milano asks the Court to annul the contested regulation, to declare that the decision of the representatives of the Member States produces no legal effects, and to order the Council and the Parliament to pay the costs related to the present proceedings. ( 17 )

50.

By a separate submission, the Parliament raised a plea of inadmissibility to which the Comune di Milano responded and which was joined to the merits of the case.

51.

In their respective responses, the Council and the Parliament ask the Court to dismiss the action as inadmissible or, in any case, as unfounded, and to order the Comune di Milano to pay the costs of the present proceedings.

52.

The Commission intervening in support of the Council and the Parliament asks the Court to dismiss the action as inadmissible and, in the alternative, as unfounded. The Netherlands Government, intervening in support of the Council and the Parliament, asks the Court to dismiss the action and to order the Comune di Milano to pay the costs related to the present proceedings.

53.

In its action, the Comune di Milano raises four grounds. One is directed against the contested regulation. The three others are directed against the decision of the representatives of the Member States.

54.

As regards the first ground, directed against the contested regulation, the Comune di Milano states that, first, the principles of representative democracy (Article 10 TEU) and of the institutional balance and of sincere cooperation (Article 13 TEU) have been breached. It also alleges infringement of essential procedural requirements and of Article 14 TEU. The Parliament has been deprived of its powers and of a possibility to participate in the process of the selection of the EMA’s new seat. The new seat was chosen by the Council only, and outside of the ordinary legislative procedure. Within the ordinary legislative procedure, the Parliament was not provided with any room to intervene in order to assess or even question that decision. According to the Comune di Milano, if the Parliament had blocked the designation of Amsterdam as the new seat of the EMA, then this would have provoked a political crisis which would have been detrimental to an agency that is essential for the protection of European citizens’ health, and could have left the EMA’s officials and their families on the territory of a third country.

55.

As regards the second, third and fourth grounds, directed against the decision of the representatives of the Member States, the Comune di Milano claims that there has been a misuse of powers, an infringement of the principles of transparency, and of good administration and equity (second ground), a breach of the principle of good administrative, transparency and sincere cooperation (third ground) and a breach of the decision of the Council of 1 December 2009, ( 18 ) and of ‘the rules of procedure of the Council of 31 October 2017’ ( 19 ) (fourth ground).

56.

More specifically, in the context of the second ground, the Comune di Milano contests the use of a decision-making process by lot because such a process did not allow for the established technical criteria to be taken into account and the best bid to be selected. It also alleges that the Commission in fact failed to investigate, something that had been anticipated by the selection rules. The insufficient assessment made by the Commission led to a manifest breach of the principle of good administration. It influenced the vote by the Member States, during which the bid of the Kingdom of the Netherlands was distorted. Furthermore, subsequent changes to that bid, negotiated between the Kingdom of the Netherlands and the EMA, breached the principles of transparency and good administration.

57.

As regards the third ground, the Comune di Milano reiterates that a decision-making process by lot is unlawful. It further criticises the absence of minutes documenting the voting process, and draws attention to the fact that the main elements of the procedure were not made public. Those main elements were not understood by the Commission and the Member States (as follows from the absence of investigation), and were not communicated to them (as regards the subsequent modifications). Finally, there was no possibility that a review could be carried out by those that had applied.

58.

Concerning the fourth ground, the Comune di Milano states that the characteristics of the vote, and the adoption of the decision of the representatives of the Member States, breached several procedural rules of the Council (to whom that decision is, according to that party, attributable). In this context, the Comune di Milano submits that the absence of the minutes amounts to an instance of an infringement of Article 13 of the Decision of the Council of 1 December 2009. ( 20 ) It also points out that there was a failure to respect formal requirements defined in ‘the rules of procedure of the Council of 31 October 2017’, ( 21 ) that is to say: absence of a statement of reasons; the impossibility for the Member States’ representatives to remain in the room during the vote count; as well as the absence of a break between the third voting round and the drawing of the lots, which would have allowed further assessment of the bids.

59.

In its defence, the Council maintains that the action is manifestly inadmissible due to the fact that the Comune di Milano lacks standing under Article 263 TFEU. On the merits, the Council states, as regards the first ground, that it has not been evidenced that the prerogatives of the Parliament have not been respected. The Parliament participated in the legislative process and discussed other options than the city of Amsterdam before rejecting them. It also made and obtained several amendments to the draft regulation. Besides, the competence to choose the seat of an agency is the competence of the Member States. The designation of the new seat of the EMA in the contested regulation is merely declaratory.

60.

As regards the second, third and fourth grounds directed against the procedure which led to the adoption of the Member States’ decision, the Council states that there is nothing to establish that the process by lot was used to pursue an objective other than that of selecting the new seat of the EMA. It is wrong to state that the selection was made independently of any qualitative comparison. The Commission was also not required to verify the factual elements. The alleged differences in the bid of the Kingdom of the Netherlands and the emerging facts after the selection procedure do not lead to the conclusion that the bid of the Kingdom of the Netherlands was distorted. In fact, the alleged distortion was not of such a seriousness and nature so as to invalidate the selection procedure. In addition, the Council’s note of 31 October 2017 did not foresee a break between the third round of voting and the drawing of the lots.

61.

The Parliament explains, in its defence, that the decision of the representatives of the Member States cannot be viewed as limiting its powers but rather as an indication of the political nature of that decision. It cannot be viewed either as a preparatory stage for the subsequent ordinary legislative procedure. The Treaties do not confer the competence to decide on the seat of agencies to the Member States. The institutions cannot abstain from exercising their functions to the benefit of the Member States. When the Parliament approved the choice of the city of Amsterdam, it did so by exercising its discretion. At no moment was the Parliament constrained by the choice of the Member States. Moreover, there is no legal link between the decision of the representatives of the Member States and the contested regulation.

62.

In its reply, the Comune di Milano rejects the arguments directed against the admissibility of its action ratione personae and, as regards the merits, submits that a link between the Member States’ decision and the contested regulation exists and that the Parliament could not effectively influence the selection of the new seat of the EMA.

63.

The Parliament and the Council submitted rejoinders. The Parliament notes that the Member States’ decision was a source of ambiguity during the legislative discussions that led to the adoption of the contested regulation, which also explains the different perspectives as to its legal value between the Parliament and the Council. It is in that context that the Parliament adopted its declaration annexed to the legislative resolution of 25 October 2018 in order to clarify where the competence to determine the seat of an agency in fact lies. The Council notes that the disagreement on that issue led to pending Case C‑743/19, Parliament v Council (Seat of the ELA), and adds, concerning the fourth ground of the action, that its rules of procedure did not apply to a decision of the representatives of the Member States.

64.

In its statement in intervention, the Commission argues that the decision of the representatives of the Member States is purely political. It has no binding value and thus cannot pre-empt the legislative process. It is through the legislative process that the political guidelines translate into legal effects. The declaration of the Parliament of 25 October 2018 is not decisive. The decisive expression of the political will of the Parliament is that which was translated into the vote in favour of the contested regulation. The grounds directed against the decision of the representatives of the Member States rely on the premiss that the latter has predetermined the decision of the new seat of the EMA in the contested regulation. Such an allegation is rejected by the Commission.

65.

In response to the second, third and fourth grounds, the Netherlands Government contests the claim of the Comune di Milano that the selection procedure is flawed.

66.

In its reply to the Commission, the Council objects to the statement that the decision of the representatives of the Member States is purely political. The new seat of the EMA was determined by that decision and not by the contested regulation.

67.

The Parliament and the Comune di Milano also replied to the statements in intervention.

(c)   Further procedure before the Court

68.

By decision of the President of the Court of 19 December 2019, the present cases have been joined for the purposes of the oral procedure and the judgment.

69.

Written observations in these joined cases have been submitted by the Italian Government, the Comune di Milano, the Parliament, the Council, the Netherlands Government, as well as the Commission.

70.

The Italian Government, the Comune di Milano, the Regione Lombardia, the Parliament, the Council, the Czech Government, Ireland, and the Spanish, French, Luxembourg, Netherlands and Slovak Governments, as well as the Commission, presented oral argument at the hearing which took place on 8 June 2021. That hearing was organised commonly for Joined Cases C‑59/18 and C‑182/18, the present Joined Cases C‑106/19 and C‑232/19, as well as for Case C‑743/19, Parliament v Council (Seat of the ELA).

V. Assessment

71.

This Opinion is structured as follows. I shall begin with the admissibility of the action introduced in Case C‑232/19 by the Comune di Milano. Having suggested that, in my view, the Comune di Milano does have standing to challenge the contested regulation (A), I will then turn to the merits of these joined cases, at least to the extent that they are in fact challenging the contested regulation. In my view, none of the arguments raised by the Italian Government and the Comune di Milano in this regard can succeed (B).

A.   Admissibility of the action in Case C‑232/19

72.

The Parliament, the Council and the Commission submit that the action brought by the Comune di Milano is inadmissible. In their view, that municipality is neither directly nor individually concerned. It has no interest in bringing proceedings either.

73.

The Comune di Milano is an entity with legal personality under Italian law. A territorial unit of a Member State, endowed with legal personality under national law, may, in principle, bring an action for annulment under the fourth paragraph of Article 263 TFEU. ( 22 ) In accordance with that provision, there are three situations in which natural and legal persons may bring actions of annulment: first, if the challenged act is addressed to them; second, if that act is of direct and individual concern to that person; and, third, if the challenged act is a regulatory act not entailing implementing measures and is of direct concern to that person.

74.

In the present case, the contested regulation is not addressed to the Comune di Milano. Nor is that regulation a regulatory act. The standing of the Comune di Milano must therefore be assessed against the requirements of the second scenario under the fourth paragraph of Article 263 TFEU: the act must be of direct (1) and individual concern to it (2). Furthermore, as a general requirement, the Comune di Milano has to show that it has an interest in bringing proceedings (3).

75.

In my view, the Comune di Milano fulfils all those requirements in the present case.

1. Direct concern

76.

According to settled case-law, ‘direct concern’ requires two cumulative criteria to be met: the contested measure must directly affect the legal situation of the individual and it must leave no discretion to its addressees who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the EU rules alone without the application of other intermediate rules. ( 23 ) I shall start with the latter criterion (a), before turning to whether the legal situation of the Comune de Milano has been affected (b).

(a) Absence of discretion or implementing measures

77.

The Comune di Milano submits that the contested regulation, which establishes erga omnes that the EMA has its seat in Amsterdam, is an obligatory and directly applicable act pursuant to Article 288 TFEU. Its application is not subject to the adoption of subsequent implementation measures.

78.

It is true that, as the Parliament and the Council submit, the fact that the challenged act is a regulation, which is generally and directly applicable, is not per se enough for the requirements relating to standing to be satisfied. ( 24 ) Indeed, ‘direct concern’ does not overlap with the ‘direct applicability’ of a regulation. ( 25 ) A different assessment must be carried out to show that that regulation directly affects the legal situation of the Comune di Milano.

79.

However, it is undisputed that the contested regulation leaves no discretion whatsoever in selecting Amsterdam as the new seat of the EMA. The designation of the seat of the EMA is automatic and results from that very regulation alone, without any other intermediate rules being necessary. The criterion related to the ‘absence of discretion or implementing rules’ is therefore clearly fulfilled in this case.

(b) Legal effects of the contested regulation

80.

The Comune di Milano submits that its legal situation is directly affected since, through the Italian Republic’s bid presenting Milan as its candidate city, it participated in the proceedings leading to the designation of the EMA’s seat, and obtained the highest number of votes. The contested regulation makes rejection of the applicant’s bid official and confirms that the seat of the EMA will not be located in its territory.

81.

The Council and the Parliament, supported by the Commission, submit that the Comune di Milano is not directly concerned by the contested regulation.

82.

In the Parliament’s view, the decision on the seat of the EMA belongs to the legislature. In this regard, the decision of the representatives of the Member States of 20 November 2017 is deprived of binding legal effects. Since there is a lack of any legally binging connection between that decision of the representatives of the Member States and the proposal of the Commission which led to the adoption of the contested regulation, the fact that the choice of the city of Amsterdam, which stems from the Member States acting jointly, was adopted, cannot in and of itself lead to the Comune di Milano being directly concerned. The contested regulation simply establishes that the seat of the EMA will be in Amsterdam. At no point was a proposal to designate Milan instead as the seat of the EMA submitted to the legislature.

83.

For the Council, the Comune di Milano has not demonstrated that it has suffered any prejudicial effects due to the adoption of the contested regulation since that regulation is of a purely declaratory nature. Indeed, the decision on the seat of the EMA belongs to the Member States and, in that respect, the decision of the representatives of the Member States is binding. The arguments relating to the participation of Milan in the selection process pertain to the opportunity choices internal to the Member State. As a result, such arguments cannot lead to the conclusion that the Comune di Milano is directly concerned. The fact that the city of Milan, as a geographical place, was chosen by the Italian Republic in the framework of its bid does not mean that the Comune di Milano, as a territorial entity, amounts to a directly concerned person.

84.

Despite the diametrically opposed positions held by the Parliament and the Council as regards the legal nature of the decision of the representatives of the Member States, both institutions appear to agree that the designation of Amsterdam in the contested regulation does not directly concern the Comune di Milano. The arguments presented, if taken at face value, make it easy to dismiss the ‘direct concern’ of the applicant. On the one hand, if the decision of the representatives of the Member States is not legally binding on the legislature, the bidding process leading thereto has no repercussions on the legal position of the applicant. The fact that the Italian Republic presented the city of Milan as its candidate city does not provide the Comune di Milano any kind of legal interest because, before the EU legislature, that bid simply never existed. On the other hand, if the decision of the representatives of the Member States is binding, then the contested regulation is of a purely declaratory nature. This line of argument seems to suggest that, in such a situation, the contested regulation can be considered to be a confirmative act, which also leads to the inadmissibility of the application. ( 26 )

85.

The combination of these two alternative lines of argument amounts to a remarkable sophism: the choice of Amsterdam as the seat of the EMA cannot be challenged because (i) it was decided through a non-binding act (ii) which was then later included in a binding act that was itself merely confirmatory. It would thus appear that the decision is nothing short of a miracle: it simply materialised in time and space, with nobody in fact taking it and nobody being responsible for it. Needless to say, such a (divine) creation leaves a potential applicant stranded in the void, which is rather a difficult proposition to embrace, particularly in view of a regulation that is clearly an act of the EU institutions.

86.

For the reasons set out in detail in my parallel Opinion in EMA 1/ELA, ( 27 ) I indeed agree that the decision of the representatives of the Member States is an act deprived of any legal effects within the EU legal order. It is therefore not reviewable under Article 263 TFEU.

87.

However, the contested regulation is an act of the EU institutions. It is therefore, in principle, subject to full review by this Court. It cannot be otherwise: with (great) power comes (great) responsibility. Having the power to decide something goes hand in hand with owning the accountability for that decision.

88.

Therefore, whether the legal situation of the Comune di Milano is affected must be assessed with exclusive regard to the contested regulation. Is there a direct link between the contested regulation and the legal situation of the applicant?

89.

In my view, there is indeed. Milan, represented by the Comune di Milano as the territorial entity that enjoys legal personality, was a direct competitor for the designation of the seat of the EMA.

90.

In other areas of law, the Court has declared that competitors can be directly concerned by EU law acts that decide on the results of such competition. Notable areas in which this has been the case are, for example, anti-dumping, State aid, or even in cases challenging decisions declaring concentrations compatible with the internal market. ( 28 ) Rather than being a factual element only, ( 29 ) the existence of a situation of competition often defines a legal position in different areas of EU law. This has been acknowledged by the Court in the field of State aid, where the Court noted that, if an applicant demonstrates that a Commission decision is liable to place him or her in an unfavourable competitive position, this means that it produces effects on his or her legal situation. ( 30 )

91.

It is nonetheless the area of public procurement which offers the closest possible analogy to the present cases. Unsuccessful tenderers are directly concerned by decisions awarding contracts to other tenderers. ( 31 ) However, in this area of law, the ‘direct concern’ of non-selected tenderers is usually not an issue since the decision to award a contract to a tenderer is accompanied by the decision rejecting the unsuccessful tenderers. ( 32 ) That said, the fact that the ‘direct concern’ of competitors in this field is somewhat of a non-issue does not detract from the fact that the situation of competition in which the different bidders find themselves is enough, in itself, to give rise to direct concern. Quite to the contrary, the acknowledgement of the procedural rights of unsuccessful tenderers through secondary law is an express recognition of the fact that they are directly concerned by the results of the bidding procedure.

92.

Certainly, an array of specific secondary law regimes can hardly be decisive for a very unique situation such as that in the present case. However, I would still suggest that, above or beyond the particularities of those specific regimes, there is one and the same theme: competitors can legally be affected in circumstances where they are competing for an asset or resource directly awarded by EU law. A decision to allocate an asset to one person directly concerns those other competitors who are unable to obtain that same asset. Their legal situation is changed from that of being potentially successful to that of an unsuccessful candidate. What is probably the clearest example of this rather simple reasoning can be found in Les Verts, where the grant of aid by the Bureau of the Parliament to rival political groupings was considered, with relatively little discussion, to be of direct concern to the applicant association. ( 33 )

93.

Having said that, there are certainly limits to such logic. One cannot complain about not winning the lottery without first having bought a ticket. In other words, the Comune di Milano could not be considered directly concerned if it had not first presented itself as a competitor.

94.

That is, however, clearly not the case. It is not disputed that, from a factual point of view, Milan was one of the candidate cities for the seat of the EMA. This fact is above all decisive for the determination of the individual concern of the applicant. However, it is also relevant when it comes to determining the legal position of an applicant as a competitor for the purposes of ascertaining his or her direct concern. It suffices to note at this point that the city of Milan was not only and clearly one of the candidate cities during the procedure leading to the decision of the representatives of the Member States, but also that its bid was expressly considered during the legislative procedure, being the object of several amendment proposals within the procedure before the Parliament. The position of Milan as a competitor cannot therefore be doubted.

95.

Is the Comune di Milano thus concerned? If I correctly understood the argument put forward by the Council, the fact that a city, as a geographical place, is to be chosen as the seat of an EU agency, does not mean that the territorial entity which holds legal personality, in this case the Comune di Milano, is concerned.

96.

That argument simply cannot be correct. Taking this argument to its logical consequences, this would mean that even the city selected as the seat of an EU agency would not be directly concerned by the EU act establishing it as the seat. Similarly, a city from which an agency is relocated would not be concerned either. ( 34 )

97.

I find it hard to accept such a conclusion. It is indeed difficult to ignore the particularly significant factual, and also legal, consequences that the designation of an agency seat entails for a local authority, not only in terms of the benefits and challenges, but also in terms of rights and obligations. Notwithstanding the fact that the specific rights and obligations for local entities may be articulated in greater detail in the Seat Agreement that is to be concluded with the Member State concerned, the decision to establish the seat in one city, and not in another, is undoubtedly of direct concern to the local territorial entity. Irrespective of any practical consequences linked to possible economic and social benefits, the very act of designating a city as the seat of an EU agency intrinsically and immediately brings with it an impact on its legal position as a competitor for that seat. ( 35 )

98.

The role of the European cities that are (or wish to be) the seat of EU agencies cannot be reduced to that of a mere physical location in a Member State. Unlike the position of the Council, the designation of a city as the seat of an agency cannot be considered as a matter internal to the Member State only. It might be worth pointing out that, contrary to certain other instances in the past, the contested regulation establishes the seat of an agency by specifically designating a city as the territorial unit, and not a Member State. ( 36 )

99.

I thus find the argument developed by the Council impossible to maintain. Certainly, the initial selection of which city within a Member State is able to compete is a matter that is internal to a Member State. However, the selection of the city that will host the agency, and the simultaneous rejection of all other competitors, is no longer ‘just an internal matter to the Member State’. The act of the Union clearly takes a decision at the level of the individual city, and not just at the level of a Member State, thus making it concerned. ( 37 )

100.

By analogy, would that also mean therefore that a natural person, such as a Commissioner, is not directly concerned by the (EU) law act relating to his or her appointment (or dismissal) as Commissioner since, at the end of the day, it was a Member State who suggested his or her name in the first place? ( 38 ) The fact that it is a Member State who initially ‘nominates’ cannot mean that an entity which is endowed with a separate and autonomous legal personality is forever just an ‘object’ and cannot be regarded as a ‘subject’, even if clearly directly concerned by the acts that expressly refer to him or her and affect his or her legal position.

101.

In conclusion, in my view, the legal position of the Comune di Milano was directly altered by the adoption of the contested regulation. That regulation established, with legally binding effects, the city of Amsterdam as the seat of the EMA, thereby automatically having the effect of excluding Milan as the seat of that agency.

2. Individual concern

102.

For a measure of general application adopted by an EU institution to be of individual concern to a natural or legal person, the latter must be affected by the measure at issue by virtue of certain attributes which are peculiar to that person, or by reason of a factual situation which differentiates that person from all other persons and distinguishes him or her in the same way as an addressee. ( 39 )

103.

In its application, the Comune di Milano states that it has been fully involved in the preparation of the bid and in the selection process mentioned in recital 1 and in Article 1 of the contested regulation. In its particular position as a candidate city in the context of the selection procedure, the Comune di Milano is individually concerned by the contested regulation. Indeed, Milan would have been mentioned in Article 1 of the contested regulation had the city of Amsterdam not been chosen. Furthermore, in presenting Milan as the Italian bid, the Comune di Milano aimed at fostering, pursuant to Article 3 of its Statute, the socio-economic and industrial development of its territory. The establishment of the seat of the EMA in Amsterdam hinders the ability of the municipality to exercise its competences in the manner that it sees fit. Moreover, the Comune di Milano shouldered expenses and carried out research. It even received an EMA delegation in order better to understand and meet the selection criteria. The municipality also recalls that the case-law of the Court takes into consideration the situation in which a person is expressly mentioned in the preparatory acts of the challenged EU acts and also when those acts take into account specific elements concerning the applicants. To this effect, the Comune di Milano refers to the case-law on anti-dumping duties ( 40 ) and public procurement. ( 41 )

104.

The Council and the Parliament, supported by the Commission, submit that the Comune of Milan (Municipality of Milan) is not individually concerned.

105.

The Council submits that, despite its invocation of Article 3 of its Statute, the Comune di Milano has not shown how the adoption of the contested regulation has affected the specific exercise of its competences as attributed by the national legal order. The final expenses of that municipality are also irrelevant. In fact, they relate purely to a question of internal organisation which ought to be handled by the Italian State. The Council further submits that the Comune di Milano was not associated in any way during the procedure for the adoption of the contested regulation. Its participation in the preparation of the Italian bid is not sufficient to establish individual concern. The rules of procedure of 22 June 2017 do not confer any right to any other subject other than the Member States: it is for them to present the bids, to exchange information with the Commission and to participate in the voting process. The fact that some Member States associated their candidate cities during the preparation of their respective bids is immaterial.

106.

For its part, the Parliament submits that the cooperation between the Member States through the rules of procedure of 22 June 2017 is completely different to the decision-making process of the Union. Any participation of the applicant in this framework of cooperation could not ‘individualise’ the applicant in such a way as to satisfy the individual concern requirement. Furthermore, there is no EU law provision that obliges the legislature to take into account the situation of the applicant during the procedure leading to the adoption of the contested regulation. In any event, without prejudice to the value of the rules of procedure of 22 June 2017, those rules confer a role only on the Member States, not on the local authorities. ( 42 )

107.

I agree with the Parliament and the Council that the arguments put forward by the Comune di Milano as regards the socio-economic impact that the designation of the seat in its territory would have had, as well as the expenses and the efforts it made in preparation of the Italian bid, are not such as to establish, in themselves, individual concern. Reliance by a regional entity on the fact that an EU act is capable of affecting certain socio-economic conditions within its territorial jurisdiction is not sufficient for that entity to be regarded as concerned, nor, a fortiori, as individually concerned. ( 43 )

108.

I also agree with the Council that it cannot be considered that the Comune di Milano has been affected in the exercise of its prerogatives by the contested regulation. In my view, the Vlaams Gewest test ( 44 ) is not relevant for the present proceedings. I do not see how the fact that Amsterdam has been designated as the seat of the EMA by the contested regulation, and not Milan, could hinder the latter from exercising its autonomous powers for the purposes of the Vlaams Gewest test. The link with the exercise of those powers is, at most, indirect and hypothetical.

109.

However, the present case is not about a territorial entity being concerned because the exercise of its autonomous competences has been curtailed (the Vlaams Gewest test). ( 45 ) The concern of the Comune di Milano in this case arises from its position as a competitor, given that the city of Milan was not selected as the seat of an EU agency under the contested regulation. It is precisely with regard to the specific selection of the seat of the EMA, brought about by the contested regulation, that the individual concern of that municipality must be assessed. What is relevant in this regard is what is commonly referred to as the Plaumann test: the decisive criterion relies on the attributes peculiar to the applicant, or, alternatively, on the factual situation which differentiates that applicant from all other persons and distinguishes him or her in the same way as an addressee. ( 46 )

110.

There are a number of factors that ‘individualise’ the situation of the Comune di Milano and thereby differentiate it from any other person, making it akin to that of an addressee. The emphasis must be placed on the factual situation which the contested regulation and the proceeding leading to its adoption have placed on the Comune di Milano.

111.

First, the very first recital of the contested regulation states that the selection of Amsterdam as the new seat for the EMA follows from the decision of the representatives of the Member States. This recital embodies the very purpose of the adoption of the contested regulation. Regardless of whether that decision produces legal effects or not, from a factual point of view, that decision forms the basis upon which the seat of the EMA was established. Therefore, also from a factual perspective, it cannot be ignored that Milan was one of the candidate cities being considered and one that received votes. As such, the city of Milan, and more precisely the Comune di Milano, did not only belong to the quite circumscribed, closed group of candidate cities, but was further individualised by way of the selection procedure before the Member States, where it arrived at the final stage as the only direct competitor to Amsterdam, and saw its bid dismissed because of the application of the rules on the drawing of lots.

112.

Second, as the Council has put forward in its defence in Case C‑106/19, Milan was also discussed as a possible seat of the EMA during the legislative procedure, as several (unsuccessful) amendments were tabled during the parliamentary proceedings. ( 47 )

113.

In summary, the procedure leading to the decision of the Member States, as well as the legislative procedure culminating in the adoption of the contested regulation, reveal the particular factual circumstances that distinguish, and even individualise, the Comune di Milano. That municipality, as the legal embodiment of one of the candidate cities, is individually concerned by the regulation, which determines the fate of its chances to be selected as the seat of the EMA. ( 48 )

3. Interest in bringing proceedings

114.

According to the Court’s settled case-law, an action for annulment brought by a natural or legal person is admissible only in so far as that person has an interest in having the contested act annulled. Such an interest requires that the annulment of that act must be capable, in itself, of having legal consequences. The action may therefore, through its outcome, procure an advantage to the party which brought it. The proof of such an interest, which is evaluated at the date on which the action is brought and which is an essential and fundamental prerequisite for any legal proceedings, must be adduced by the applicant. ( 49 )

115.

In its application, the Comune di Milano submits that it has an interest in bringing proceedings. First, if its application is successful, the city of Milan could obtain the bid for the seat of the EMA without a new selection procedure being necessary. In the event that it were necessary to repeat such a procedure, the Italian bid would be the one with the best chances of success in view of its objective qualities. Even if the seat of the EMA were not allocated to the city of Milan for whatever reason, Milan would retain its interest to act. It could ask for its situation to be restored in the form of economic compensation. It could also benefit if it were the candidate in future bids for the seat of other agencies or bodies of the Union, since the selection procedures will not be affected by the irregularities that the Court would find in the present proceedings. Finally, the Comune di Milano has an interest to act given the important socio-economic and industrial impact of the transfer of the EMA seat to its territory.

116.

The Council, the Parliament and the Commission consider that the Comune di Milano does not have an interest in bringing proceedings. First, the Council and the Parliament essentially submit that the success of the applicant’s action does not necessarily mean that the seat of the EMA would be allocated to Milan. Even if the Italian Republic decided again to present Milan as its candidate city, it is impossible to foresee the results of future designations. Any potential future interest in a future selection procedure that is not tainted by unlawfulness is indeed hypothetical. There is no direct and actual interest, but rather only a potential and indirect one. Second, according to the Council, the argument relating to a potential claim of compensation should also be rejected. The contested regulation is not the cause of the alleged damage suffered by the Comune di Milano. Third, the consequences relating to the socio-economic and industrial interests are not relevant since the Court has stated that those considerations are not sufficient to prove an interest to act. Fourth, according to the Parliament, the regulation does not interfere with the legislative or financial autonomy of the applicant. Neither can it invoke a personal interest based on its participation in the selection procedure. The Comune di Milano does not have a personal interest that is different from the one of the Italian State.

117.

I agree that, even if in principle, the possibility of an action for compensation is sufficient to justify an interest in bringing proceedings, ( 50 ) that action cannot be merely hypothetical. The Comune di Milano cannot simply rely on the mere possibility of bringing such an action without adducing specific evidence concerning the specific impacts of the alleged unlawfulness and the nature of the damage. ( 51 )

118.

However, irrespective of whether any potential future action for damages may be brought or not, in my view, the Comune di Milano has sufficiently proven its interest in bringing proceedings.

119.

In the event that the contested regulation were to be annulled, it is clear that the possibility for a city other than Amsterdam to be designated as the seat of the EMA would be opened anew. This includes Milan, as one of the most successful competitors in the procedure leading up to the decision of the representatives of the Member States.

120.

In this regard, although delivered in a different and specific field of EU law, the basic rationale behind the Court’s case-law on public procurement is again entirely applicable in the present case. A competitor has interest in bringing proceedings to the extent that the annulment of the contested act would entail a reopening of the selection procedure, and the possibility for the applicant to submit a new application. ( 52 ) The interest may even subsist when the competitor has lost all chances of being successful in the tender since he or she would potentially benefit in the future from procedures ‘free of mistakes’ of the same kind. ( 53 ) The rationale of avoiding future unlawfulness goes indeed beyond the specific framework of the case-law on public procurement. ( 54 ) Again, although the contested selection procedure was very specific and sui generis in nature, what other logic is there within such a specific context, which, by the design of its creators, strongly resembles that of a tender?

121.

Finally, the fact that the Italian Government brought an independent action is immaterial. As settled by case-law, the fact that a Member State and one of its entities both have an interest in bringing proceedings against the same measure does not mean that the entity’s interest in bringing proceedings was not sufficient to render admissible an action for annulment based on the fourth paragraph of Article 263 TFEU. ( 55 )

122.

In summary, I consider the Comune di Milano to have standing to challenge the contested regulation and interest in doing so. I am well aware that the case-law of this Court is strict in terms of standing for non-privileged applicants under the fourth paragraph of Article 263 TFEU. While certainly demanding, that case-law should nonetheless not be pushed into a realm of the bizarre and thus unjust. At some basic level of intuition, before the issue is clouded by an avalanche of case-law filled with detail as to why nobody can challenge anything directly before the EU Courts, the issue of standing of the Comune di Milano is actually rather simple: in such very particular and rare circumstances, that city is clearly concerned by the fact that it was not selected.

123.

In this regard, I have always found it very helpful occasionally to verify the legal solutions that I am contemplating with normal people: that is to say not EU lawyers, ideally not even lawyers. It could be called a reality check. Am I able to explain certain legal ideas and propositions to intelligent human beings? If I am not, it is likely that those ideas fail to convince. Or they are simply wrong. I find it rather challenging to explain (and justify), within such a context, the proposition that somebody who participated in a (closed) selection procedure but who was not selected is not concerned by the outcome of that selection procedure, and has no interest whatsoever in challenging it. That is even before I add that if such a competitor does not have standing before this Court, realistically he or she cannot go anywhere else.

B.   Merits

124.

In terms of the merits, the present cases are extremely complex, but at the same time possibly quite straightforward.

125.

Upon initial inspection, a number of the arguments raised by the parties in the present cases are simply baffling, amounting to nothing less than advanced legal acrobatics. A Member State and a local entity are seeking to protect the prerogatives of the European Parliament in a specific case, apparently against the will of that very Parliament, while in parallel proceedings that latter body insists on upholding those same prerogatives. A Member State is alleging that the Member States do not have the competence to take a decision on the seats of agencies, but was previously and apparently subsequently willing to participate in those exact selection procedures. As for the Council, it posits that the decision of the representatives of the Member States on the seat of an EU agency adopted pursuant to Article 341 TFEU is binding on everyone, without anybody actually being subsequently limited in their legislative powers, in particular, with regard to where exactly that issue ought to be settled.

126.

There are several reasons as to why the different argumentative positions are intriguing. The present litigation unites five different cases within which different actors pursue somewhat nuanced interests. There is also significant complexity as a result of the connection, certainly in factual terms and in the past institutional practice, between the decision of the representatives of the Member States and its ‘implementation’ in the legal order of the Union thereafter. Within such settings, it is indeed impossible to maintain an overall coherent position throughout all of the cases, and to connect the different types of practice in the past with the current constitutional set up, while also ensuring that it all fits together in perfect harmony.

127.

However, if the Court were to agree with the proposed solution, outlined in my parallel Opinion in EMA 1/ELA, to the crucial (upstream) question concerning the legal nature of the decision of the representatives of the Member States, setting out their preferences as to where the seat of a new EU agency should lie, then the solution to the (downstream) issues, brought about by the present joined cases, as regards an EU law act, would not be that difficult. Basing myself on that assumption, in the following section, I shall suggest that neither the ground alleging a breach of the Parliament’s prerogatives (1), nor the one alleging that the EU internal (ordinary legislative) procedure has essentially been tainted by its association with the decision of the representatives of the Member States (2), can succeed in my view.

1. The first grounds in Case C‑106/19 and in Case C‑232/19: the alleged breach of the Parliament’s prerogatives

128.

As its first ground in Case C‑106/19, the Italian Government is alleging an infringement of Articles 10, 13, 14(1) TEU and of Articles 114, 168(4)(c), 289 and 294 TFEU. Those arguments are echoed in the first ground of the Comune di Milano in Case C‑232/19. Those arguments, which will be dealt with together, suggest in essence that the Parliament’s role as a co-legislator was diminished in the process leading to the selection of the new seat of the EMA.

129.

I find it necessary to start first by noting that, unlike Joined Cases C‑59/18 and C‑182/18, the present cases raise no issue as to whether the contested regulation is an act whose legality can be reviewed under Article 263 TFEU. The contested regulation has been adopted by way of the ordinary legislative procedure pursuant to Article 294 TFEU and therefore constitutes a legislative act. ( 56 )

130.

Second, the arguments of the Italian Government and the Comune di Milano, submitting that the Parliament was excluded from the selection process of the new seat of the EMA, appear to be based on the premiss that there is a legally binding link between the decision of the representatives of the Member States and the contested regulation. That premiss consists in presenting the former as the binding source for the latter in terms of the selection of the new seat of the EMA.

131.

Like the views expressed by the Parliament and the Commission in the present proceedings, I consider that premiss to be incorrect. As explained in detail in my parallel Opinion in EMA 1/ELA, ( 57 ) the political decision of the representatives of the Member States was adopted based on the specific procedural rules agreed upon by those Member States outside of the EU law system. While it is true that those rules attributed a specific role to the Commission, they did not attribute any role to the Parliament.

132.

Therefore, the mere fact that the Parliament was not involved in a procedure that led to the Member States’ political – and as a matter of EU law non-binding – decision on the new seat of the EMA, cannot be seen as a breach or a circumvention of the Parliament’s prerogatives as an equal co-legislator.

133.

Third, and as the Commission rightly recalls in its statement in intervention in Case C‑232/19, the Court held, in Poland v Parliament and Council, that it is for the Parliament and the Council ‘alone to decide the content of a measure’ in the exercise of their legislative power ‘conferred in Article 14(1) TEU and Article 16(1) TEU …’. ( 58 )

134.

Contrary to the claim of the Council, made in its reply to the statement in intervention by the Commission, I do not consider the relevance of that case-law to be limited to the political guidelines of the European Council. The role of the European Council is indeed described in Article 15 TEU. However, that logically cannot be the case of a procedure established by the Member States among themselves that remains outside the structure of EU institutions and which cannot produce within the EU legal order any legal effects. What the situation at issue in Poland v Parliament and Council and the current one have in common is that a political decision taken outside the legislative procedure cannot pre-empt the latter as regards its specific outcome.

135.

It is in the light of that context, taken as the starting point, that the legality of the contested regulation is to be reviewed. In doing so, the standard of review is necessarily circumscribed by the nature of the political discretion exercised by an EU institution such as the Parliament. ( 59 )

136.

As regards the ordinary legislative procedure that led to the adoption of the contested regulation, I recall that the Parliament enjoys procedural rights flowing from its status as co-legislator which places it on an equal footing with the Council, as foreseen by Article 294 TFEU. Those procedural rights, which can be exercised within the respective readings or within the Conciliation Committee, effectively provide the Parliament with the possibility not only to influence, but to co-shape the outcome of the legislative process. If need be, the Parliament may even reject the proposed legislative act.

137.

Thus, if the Parliament did not agree with the decision to move the seat of the EMA to Amsterdam, it was equipped with the possibility to prevent the political decision previously taken by the Member States, and proposed by the Commission, from being enshrined in the content of a binding legislative act of EU law. However, that clearly was not the case during the ordinary legislative procedure which unfolded in the present cases, as pointed out by the Parliament itself.

138.

First, the Parliament discussed the Commission’s draft legislative proposal ( 60 ) at its proceedings on 12 to 15 March 2018. It adopted a number of amendments, while not expressing any disagreement with the decision that the EMA should have its seat in Amsterdam. ( 61 ) Prior to that, and as the Council mentions in Case C‑106/19, amendments were tabled within the respective committee suggesting that the new seat of the EMA ought to be located in Milan. ( 62 ) The justification of one of those amendments mentioned ‘a number of official statements and press reports refer[ring] to the impossibility of finding suitable premises for the European Medicines Agency headquarters in Amsterdam by March 2019, leading to the conclusion that the Council decision [sic] cannot at present be implemented. The choice of Milan, which can offer an available, totally suitable and immediately operational headquarters, would make it possible to avoid inconvenience, additional costs and repercussions regarding the right to health of the citizens and would ensure business continuity’. ( 63 ) However, the Parliament did not retain those suggestions. ( 64 )

139.

Second, the Parliament’s amendments were submitted to the Council. ( 65 ) Informal negotiations between the Council and the Parliament followed, during which several points raised by the latter were accepted, as is apparent from the final text of the contested regulation on which the two co-legislators agreed on 16 October 2018. ( 66 )

140.

Third, the Parliament voted on the draft legislative act on 25 October 2018, taking into account a number of informal exchanges that had taken place between the Council, the Parliament and the Commission with the intention of reaching an agreement on the matter at first reading, thereby avoiding the need for a second reading or conciliation. ( 67 )

141.

Finally, the contested regulation was adopted on 14 November 2018 and published in the Official Journal on 16 November 2018. ( 68 )

142.

In view of the details of the legislative process described above, which led to the adoption of the contested regulation, I struggle to see how the role of the Parliament was diminished to a purely formal one.

143.

Again, if the Parliament wished to express its disagreement with the choice of Amsterdam as the new seat of the EMA, it had a number of formal and informal opportunities to do so. However, the legislative procedure reveals that many of the Parliament’s amendments were in fact accepted by the Council and found their way into the final text of the contested regulation. Yet, the seat itself was never contested by the Parliament in the course of the ordinary legislative procedure.

144.

In my view, it is only in the light of this overall context that one may properly assess the ‘regrets’ expressed by the Parliament in the annex to its resolution of 25 October 2018. ( 69 ) Indeed, on that occasion, the Parliament noted that its role of co-legislator had ‘not been duly taken into account since it was not involved in the procedure leading to the selection of the new seat of the [EMA]’. ( 70 )

145.

However, first, that statement must be understood as relating to the selection process taking place at the meeting of the representatives of the Member States, which occurred ahead of the ordinary legislative procedure, to which the Parliament was not associated because the Member States did not wish for that institution to be so. The fact that the Member States did not wish to associate the Parliament cannot per se amount to a breach of the Parliament’s prerogatives since, as regards that which takes place outside the EU legal system, the Parliament enjoys no prerogatives of co-decision provided for by the Treaties.

146.

Second, as for the repercussions of a decision already reached by the Member States outside the system of the Treaties, it is indeed entirely possible to understand the Parliament’s wish, expressed in the resolution mentioned above, for an involvement in the informal process that preceded the ordinary legislative one, especially if a decision on the seat of an agency was already to take place there.

147.

However, it is not the role of this Court to act on political regrets concerning the past, nor desires for the future. The bottom line remains that the Parliament had the opportunity to have its say on the matter in the ordinary legislative procedure. It nevertheless decided, for whatever reasons, not to contest the choice of the seat previously made by the representatives of the Member States, and not to stand its ground on that occasion. ( 71 ) The truth is, those choices are simply a matter of political opportunity, signalling and strategy, with nothing amenable to judicial review.

148.

The same appears to be confirmed by the position adopted by the Parliament in Case C‑232/19. The Parliament indeed argues that the content of the contested regulation was adopted independently of the decision of the representatives of the Member States, in a procedure in which the Parliament played its autonomous role as co-legislator, by exercising its discretion, and without being constrained at any moment by the political choice made by the Member States.

149.

Furthermore, it is worth pointing out that neither the Italian Government, nor the Comune di Milano, allege that the Parliament failed to exercise its co-legislative discretion to the extent that a breach of the requisite standards would arise. It might be again recalled that the broad discretion enjoyed by the EU institutions in the exercise of their legislative powers is, in principle, subject to limited judicial review, with the aim of determining, inter alia, the sufficiency of its statement of reasons and the absence of manifest errors of assessment. ( 72 )

150.

In this respect, the preamble of the contested regulation refers to the context created by the decision of the United Kingdom to withdraw from the Union and to the decision of the representatives of the Member States of 20 November 2017 (recital 1), and to the need to ‘ensure the proper functioning of the Agency in its new location’ or ‘interrupted functioning of the Agency during and after the relocation’ (recitals 3 and 4 4). It further acknowledges the existence of ‘the extraordinary situation’ (recital 4) as well as the ‘urgency’ thereof (recital 6).

151.

Although rather concise, those statements certainly provide plausible and, in view of the standard of review, sufficient reasons as to why the city of Amsterdam was chosen as the new seat of the EMA by the EU legislature.

152.

In the light of the foregoing, I suggest that the Court dismiss the first ground of the action in Case C‑106/19 and the first ground of the action in Case C‑232/19.

2. Second ground in Case C‑106/19 concerning the unlawfulness of the contested regulation deriving from the unlawfulness of the decision of the representatives of the Member States and the second, third and fourth grounds in Case C‑232/19

153.

The second ground of the action introduced by the Italian Government in Case C‑106/19, as well as the second to fourth grounds in Case C‑232/19, consist in alleging that the unlawfulness of the contested regulation derives from the initial unlawfulness of the decision of the representatives of the Member States. Those arguments in effect raise a ‘fruit of the poisonous tree’ argument: since the initial decision of the representatives of the Member States was adopted unlawfully, the choice of the seat of the EMA, subsequently enshrined in the contested regulation, was naturally vitiated by the same flaw.

154.

Two answers are to be given in response to those arguments.

155.

First, given that the Parliament had no role to play in the informal stage of the selection of the new seat of the EMA, then the Parliament’s prerogatives could not have been breached at that informal stage. Those prerogatives were also not breached throughout the ordinary legislative procedure that preceded the adoption of the contested regulation for the reasons already explained in the previous section of this Opinion.

156.

Second, the decision of the representatives of the Member States on the seat of an agency, which does not fall under Article 341 TFEU and therefore cannot be based upon it, is not a challengeable act under Article 263 TFEU. Such an act, authored by the Member States, has no binding legal effects within the EU legal order. As such, the institutions taking part in the ordinary legislative procedure which concerns the designation of an agency can naturally freely disregard such a non-binding political wish as regards the location of the new seat of an agency. However, this does mean that the possible flaws of that (non-binding) act cannot affect the legality of the ordinary legislative procedure that is independent of it.

157.

In short, since it is not binding, the logic of ‘unlawfulness by association’, raised under this heading by the Italian Government and the Comune di Milano, simply does not work. Moreover, as to the rest, the second ground in Case C‑106/19 and the second to fourth grounds in Case C‑232/19 are in fact directed against a decision of the Member States which falls outside the jurisdiction of the Court.

158.

Thus, in the light of the foregoing, I suggest that the Court dismiss the second ground in Case C‑106/19, as well as the second to fourth grounds in Case C‑232/19.

159.

In conclusion, I would add that one can understand the dissatisfaction of a losing bidder in a competition that, while starting off as a competition based on merits with a defined list of criteria on which the competitors will be evaluated, ends by way of a decision that ultimately comes down to sheer luck through the drawing of lots.

160.

That said, in structural terms, and in nuance to the opening of this Opinion, there might in fact be circumstances within which the non-reviewable outcome through the drawing of lots does in fact make a lot of sense, including in legal decision-making. That is in particular in the interest of making a (cost-efficient) decision between, what is likely to be at that stage, equally plausible candidates. There is a natural difference in the logic of drawing lots as the sole selection criterion (where merit does not matter, it is simply down to luck), as opposed to the drawing of lots at the end of a selection process based on merits, where the hypothetical state of affairs is that there are only a few tied candidates, all of them more or less equal on merits (and there is no particular appetite to spend the next few days locked in a Sistine Chapel, carrying out successive rounds of voting until white smoke emerges).

161.

Be that as it may, when the rules for the contested selection were set, the Italian Republic, as well as all the other Member States agreeing to those rules, was behind an almost perfect ‘veil of ignorance’ as to the result of the selection process. Indeed, there is little doubt that those Member States were agreeing to the rules in the abstract, unaware that later down the line those rules would actually end up being applied to their benefit or detriment. If political philosophy is to be believed on this point, rules agreed in such a manner are by definition fairer than any other rules. ( 73 )

162.

This is not to say that the concrete selection procedure was flawless. It is rather to suggest that if, more generally, at present, the Italian Republic, and/or any other Member States, and in view of the EU competence to decide on the seat of an agencies, EU institutions, no longer believe that, in the light of the stated aims and interests, such rules are appropriate, then they are naturally free to (co-)design them in a better way for the future.

C. Costs

163.

Under Article 138(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs.

164.

At the formal level, it is true that, in the present cases, the Comune di Milano and the Italian Republic were unsuccessful inasmuch as it has been established that the grounds directed against the contested regulation are unfounded and that the Court lacks jurisdiction for those grounds in Case C‑232/19 that are directed against the decision of the representatives of the Member States.

165.

However, in view of the facts that (i) this has been a complex, inherently institutional litigation, which has been as much about the past cases as it has about clarifying the rules for the future; (ii) the outcome of the present joined cases became effectively tied to the outcome of another set of joined cases, within which the declaration sought by the Comune di Milano in the present proceedings was in fact indirectly provided; and (iii) the Court joined the present cases and held a common hearing together with Cases C‑59/18, C‑182/18 and C‑743/19, following which a backwards earmarking of the exact costs for each individual case might be a rather complex exercise, I would find it more fair and equitable exceptionally to apply Article 138(3) of the Rules of Procedure and to order (all) the parties to bear their own costs.

D. Conclusion

166.

In Case C‑106/19, I propose that the Court should:

Dismiss the action;

Order the Italian Republic, the Council of the European Union and the European Parliament to bear their own costs;

Order the Kingdom of the Netherlands and the European Commission to bear their own costs.

167.

In Case C‑232/19, I propose that the Court should:

Dismiss the action;

Hold that it lacks jurisdiction to hear the action to the extent that it invites the Court to declare without legal effects the decision of the representatives of the Member States adopted on 20 November 2017 in the margins of a meeting of the Council of the European Union locating the new seat of the European Medicines Agency in Amsterdam;

Order the Comune di Milano, the Council and the European Parliament to bear their own costs;

Order the Kingdom of the Netherlands and the European Commission to bear their own costs.


( 1 ) Original language: English.

( 2 ) Duxbury, N., Random Justice: On Lotteries and Legal Decision-Making, Clarendon Press, Oxford, 1999, in particular pp. 5 and 14.

( 3 ) While doing so indirectly, with the submissions of the Comune di Milano in particular claiming that the selection of the new EMA seat carried out in this way was vitiated by misuse of powers, violation of principles of transparency, of good administration and equity.

( 4 ) Opinion in Italy and Comune di Milano v Council (Seat of the European Medicines Agency) and Parliament v Council (Seat of the European Labour Authority) (Joined Cases C‑59/18 and C‑182/18, and Case C‑743/19) (‘EMA 1/ELA’), delivered on the same day as the present Opinion.

( 5 ) Regulation of the European Parliament and of the Council of 14 November 2018 amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (OJ 2018 L 291, p. 3).

( 6 ) Document P8_TA(2018)0427, European Parliament legislative resolution of 25 October 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (COM(2017)0735‑C8 ‑ 0421/2017‑2017/0328(COD)).

( 7 ) OJ 1993 L 214, p. 1.

( 8 ) Decision taken by common Agreement between the Representatives of the Governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol (OJ 1993 C 323, p. 1).

( 9 ) OJ 2004 L 136, p. 1.

( 10 ) Council Document XT 21045/17 – Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union.

( 11 ) Council Document 14559/17 – Outcome of the Council meeting (3579th Council Meeting, General Affairs (Article 50)).

( 12 ) Press Release of 20 November 2017, ‘European Medicines Agency to be relocated to Amsterdam, the Netherlands’ – https://www.consilium.europa.eu/en/press/press-releases/2017/11/20/european-medicines-agency-to-be-relocated-to-city-country/.

( 13 ) See the last sentence of point 1 of the Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (COM/2017/0735 final).

( 14 ) See Article 71a of Regulation No 726/2004, as amended by Article 1 of Regulation (EU) 2018/1718 of the European Parliament and of the Council of 14 November 2018 (OJ 2018 L 291, p. 3).

( 15 ) For the sake of completeness, it should be acknowledged that, before engaging in detail with the two grounds invoked, the Italian Government, also in the context of the present proceedings challenging the lawfulness of the contested regulation, sets out its view as to why the decision on the seat of agencies is an exclusive competence of the European Union and not one of the Member States. Those arguments are, however, addressed in detail in my parallel Opinion in EMA 1/ELA (footnote 4), within which the Italian Government participated and was fully heard. Therefore, I limit the restatement of the position of the Italian Government for the purposes of the present Opinion only to the two grounds invoked specifically with regard to the contested regulation.

( 16 ) Decision taken by common accord between the Representatives of the Governments of the Member States of 13 June 2019 on the location of the seat of the European Labour Authority (OJ 2019 L 189, p. 68). The decision on the seat of the ELA was instituted by Regulation (EU) 2019/1149 of the European Parliament and of the Council of 20 June 2019 establishing a European Labour Authority, amending Regulations (EC) No 883/2004, (EU) No 492/2011, and (EU) 2016/589 and repealing Decision (EU) 2016/344 (OJ 2019 L 186, p. 21).

( 17 ) The action was initially introduced before the General Court (Case T‑75/19). On 13 March 2019, the General Court decided, in accordance with the third paragraph of Article 54 of the Statute of the Court of Justice and of Article 128 of the Rules of Procedure of the General Court, to decline jurisdiction in favour of the Court so as to allow the Court to rule on that action in view of the fact that, in Case T‑75/19, the issue of the validity of the same act was raised as in Case C‑106/19 (order of 13 March 2019, Comune di Milano v Parliament and Council, T‑75/19, not published, EU:T:2019:163).

( 18 ) Council Decision of 1 December 2009 adopting the Council’s Rules of Procedure (2009/937/EU) (OJ 2009 L 325, p. 35).

( 19 ) The quotes added. It follows from Annex 5 to the action of the Comune di Milano that that party refers to the note of the Council of 31 October 2017, Council Document XT 21092/17 – Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union, which supplements the selection rules on practical questions regarding voting (Council Document XT 21045/17, quoted above, footnote 10).

( 20 ) Council Decision of 1 December 2009 adopting the Council’s Rules of Procedure (2009/937/EU) (OJ 2009 L 325, p. 35).

( 21 ) See above, footnote 19 of this Opinion.

( 22 ) Order of 9 July 2013, Regione Puglia v Commission (C‑586/11 P, not published, EU:C:2013:459, paragraph 30 and the case-law cited).

( 23 ) Judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci (C‑622/16 P to C‑624/16 P, EU:C:2018:873, paragraph 42 and the case-law cited).

( 24 ) Order of 12 October 2011, GS v Parliament and Council (T‑149/11, not published, EU:T:2011:590, paragraph 24 and the case-law cited).

( 25 ) In the same way as ‘direct effect’ does not amount to ‘direct concern’ as far as the standing to challenge directives is concerned – see my Opinion in Nordstream 2 AG v Parliament and Council (C‑348/20 P, points 35 to 46).

( 26 ) See, for example, judgments of 25 October 1977, Metro SB-Großmärkte v Commission (26/76, EU:C:1977:167, paragraph 4), or of 15 December 1988, Irish Cement v Commission (166/86 and 220/86, EU:C:1988:549, paragraph 16).

( 27 ) My Opinion in EMA 1/ELA, points 164 to 176.

( 28 ) See, for a systematisation of the case-law regarding the standing of competitors in those fields, judgment of 3 May 2018, Distillerie Bonollo and Others v Council (T‑431/12, EU:T:2018:251, paragraphs 54 to 59).

( 29 ) The competitive position on the market has been considered as a factual element in some instances. See, for example, Opinion of Advocate General Kokott in Inuit Tapiriit Kanatami and Others v Parliament and Council (C‑583/11 P, EU:C:2013:21, point 71), and judgment of 3 May 2018, Distillerie Bonollo and Others v Council (T‑431/12, EU:T:2018:251, paragraph 52).

( 30 ) Judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci (C‑622/16 P to C‑624/16 P, EU:C:2018:873, paragraph 47).

( 31 ) See, for a recent example, judgment of 10 February 2021, Sophia Group v Parliament (T‑578/19, not published, EU:T:2021:77). See also judgment of 20 March 2013, Nexans France v Joint Undertaking Fusion for Energy (T‑415/10, EU:T:2013:141, paragraph 55 and the case-law cited).

( 32 ) See, for example, Article 170 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ 2018 L 193, p. 1).

( 33 ) Judgment of 23 April 1986, Les Verts v Parliament (294/83, EU:C:1986:166, paragraphs 29 to 31).

( 34 ) In the present case, the city of London would be placed in a similar position as Amsterdam itself, in so far as nationality is irrelevant for the purposes of standing under the fourth paragraph of Article 263 TFEU, even when it comes to the standing of third States (judgment of 22 June 2021, Venezuela v Council, C‑872/19 P, EU:C:2021:507). The reasoning developed in paragraphs 40 to 53 of that judgment is entirely applicable to territorial entities of third States.

( 35 ) It goes without saying that the case-law concerning EU funds is, for this reason, not analogically applicable in this connection. See, for example, judgment of 22 March 2007, Regione Siciliana v Commission (C‑15/06 P, EU:C:2007:183).

( 36 ) See, for example, Article 4(2) of Regulation (EEC) No 1365/75 of the Council of 26 May 1975 on the creation of a European Foundation for the improvement of living and working conditions (OJ 1975 L 139, p. 1), which provided that ‘the seat of the Foundation shall be in Ireland’. Also, the representatives of the Governments of the Member States, meeting at the Head of State and Government level on 29 October 1993, decided that the Office for Harmonisation in the Internal Market (trademarks and designs) should have its seat in Spain, in a town to be determined by the Spanish Government – Decision taken by common Agreement between the Representatives of the Governments of the Member States, meeting at Head of State and Government level, on the location of the seats of certain bodies and departments of the European Communities and of Europol (OJ 1993 C 323, p. 1).

( 37 ) If the reasoning of the Council were followed to its (il)logical conclusion, and all of this were indeed a matter ‘purely internal’ to a Member State, then that Member State, whose proposed city was selected, should also be free simply to ‘dislocate’ the seat of the agency to another place within its geographical territory. Thus, the Kingdom of the Netherlands would remain free to move the EMA at any time to, for instance, Tilburg or Lelystad.

( 38 ) Incidentally, no discussion on the requirement of ‘direct concern’ can be found in judgment of 12 May 2015, Dalli v Commission (T‑562/12, EU:T:2015:270), concerning the application for the annulment of an oral decision allegedly taken by the then President of the Commission to exercise his power to request the applicant’s resignation as a Member of the Commission, pursuant to Article 17(6) TEU.

( 39 ) See, to that effect, inter alia, judgments of 15 July 1963, Plaumann v Commission (25/62, EU:C:1963:17, p. 107), and of 15 July 2021, Deutsche Lufthansa v Commission (C‑453/19 P, EU:C:2021:608, paragraph 33 and the case-law cited).

( 40 ) Judgment of 16 May 1991, Extramet Industrie v Council (C‑358/89, EU:C:1991:214, paragraphs 14 and 15 and the case-law cited).

( 41 ) Judgment of 28 October 1982, Groupement des Agences de voyages v Commission (135/81, EU:C:1982:371, paragraph 11).

( 42 ) Citing, by analogy, order of 2 June 2008, WWF-UK v Council (T‑91/07, not published, EU:T:2008:170, paragraph 72).

( 43 ) See to that effect, order of 16 June 1998, Comunidad Autónoma de Cantabria v Council (T‑238/97, EU:T:1998:126, paragraphs 49 and 50 and the case-law cited), and order of 23 October 1998, Regione Puglia v Commission and Spain (T‑609/97, EU:T:1998:249, paragraphs 21 and 22).

( 44 ) See, in particular, judgments of 30 April 1998, Vlaams Gewest v Commission (T‑214/95, EU:T:1998:77, paragraph 29); of 23 October 2002, Diputación Foral de Guipúzcoa v Commission (T‑269/99, T‑271/99 and T‑272/99, EU:T:2002:258, paragraph 41); of 15 June 1999, Regione Autonoma Friuli-Venezia Giulia v Commission (T‑288/97, EU:T:1999:125, paragraph 32); or of 5 October 2005, Land Oberösterreich v Commission (T‑366/03 and T‑235/04, EU:T:2005:347, paragraph 28). For a more extensive analysis of this case-law, see my Opinion in Région de Bruxelles-Capitale v Commission (C‑352/19 P, EU:C:2020:588, points 58 to 62).

( 45 ) In any case, the Vlaams Gewest test is clearly not the only way in which a regional entity might prove its direct and individual concern – see, for instance, judgment of 10 February 2000, Nederlandse Antillen v Commission (T‑32/98 and T‑41/98, EU:T:2000:36, paragraphs 50 to 57).

( 46 ) See footnote 39.

( 47 ) See ‘Amendments 39, 46, 47 and 48’. Proposal for a regulation of 31 January 2018 by the Committee on the Environment, Public Health and Food Safety, ‘Amendments 1-51, Draft report Giovanni La Via, Location of the seat of the European Medicines Agency’ (COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)) – https://www.europarl.europa.eu/doceo/document/ENVI-AM-616891_EN.pdf.

( 48 ) See, by analogy, judgments of 6 March 1979, Simmenthal v Commission (92/78, EU:C:1979:53, paragraphs 25 and 26), and of 29 April 2004, Commission v CAS Succhi di Frutta (C‑496/99 P, EU:C:2004:236, paragraph 57).

( 49 ) See, for example, judgment of 27 March 2019, Canadian Solar Emea and Others v Council (C‑236/17 P, EU:C:2019:258, paragraph 91).

( 50 ) See, to that effect, judgment of 17 September 2015, Mory and Others v Commission (C‑33/14 P, EU:C:2015:609, paragraphs 69 and 79 and the case-law cited), and of 7 November 2018, BPCLux 2 and Others v Commission (C‑544/17 P, EU:C:2018:880, paragraph 43). It could also be recalled in this context that EU institutions, even when acting outside the EU legal framework, are not shielded from actions for compensation under Articles 268 and 340 TFEU. See, in that connection, judgment of 20 September 2016, Ledra Advertising and Others v Commission and ECB (C‑8/15 P to C‑10/15 P, EU:C:2016:701, paragraphs 54 to 60).

( 51 ) See judgment of 30 April 2020, Izba Gospodarcza Producentów i Operatorów Urządzeń Rozrywkowych v Commission (C‑560/18 P, EU:C:2020:330, paragraphs 73 and 74).

( 52 ) Judgment of 6 July 2000, AICS v Parliament (T‑139/99, EU:T:2000:182, paragraph 33).

( 53 ) See, for example, judgments of 11 May 2010, PC-Ware Information Technologies v Commission (T‑121/08, EU:T:2010:183, paragraph 40), or of 20 September 2011, Evropaïki Dynamiki v EIB (T‑461/08, EU:T:2011:494, paragraphs 64 to 66).

( 54 ) See judgment of 6 September 2018, Bank Mellat v Council (C‑430/16 P, EU:C:2018:668, paragraph 64); or judgments of 7 June 2007, Wunenburger v Commission (C‑362/05 P, EU:C:2007:322, paragraphs 50 to 52), and of 22 March 2018, De Capitani v Parliament (T‑540/15, EU:T:2018:167, paragraph 32).

( 55 ) Judgments of 30 April 1998, Vlaams Gewest v Commission (T‑214/95, EU:T:1998:77, paragraph 30), and of 15 December 1999, Freistaat Sachsen and Others v Commission (T‑132/96 and T‑143/96, EU:T:1999:326, paragraph 92). See also judgment of 10 February 2000, Nederlandse Antillen v Commission (T‑32/98 and T‑41/98, EU:T:2000:36, paragraph 58).

( 56 ) See, in this regard, order of 6 September 2011, Inuit Tapiriit Kanatami and Others v Parliament and Council (T‑18/10, EU:T:2011:419, paragraph 60).

( 57 ) My Opinion in EMA 1/ELA, points 83 to 143 and 164 to 176.

( 58 ) Judgment of 21 June 2018, Poland v Parliament and Council (C‑5/16, EU:C:2018:483, paragraph 84 and the case-law cited).

( 59 ) See, in this regard, judgment of 19 December 2019, Puppinck and Others v Commission (C‑418/18 P, EU:C:2019:1113, paragraphs 95 and 96).

( 60 ) Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (COM/2017/0735 final – 2017/0328 (COD)).

( 61 ) Amendments adopted by the European Parliament on 15 March 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)) 11 (OJ 2019 C 162, p. 147).

( 62 ) See ‘Amendments 39, 46, 47 and 48’. Proposal for a regulation of 31 January 2018 by the Committee on the Environment, Public Health and Food Safety, ‘Amendments 1-51, Draft report Giovanni La Via, Location of the seat of the European Medicines Agency’ (COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)) – https://www.europarl.europa.eu/doceo/document/ENVI-AM-616891_EN.pdf.

( 63 ) Ibid., justification of Amendment 46.

( 64 ) Amendments adopted by the European Parliament on 15 March 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)) 11 (OJ 2019 C 162, p. 147).

( 65 ) Interinstitutional File 2017/0328 (COD), No 7098/18 of 21 March 2018.

( 66 ) Interinstitutional File 2017/0328 (COD), No 13176/18 of 16 October 2018.

( 67 ) Interinstitutional File 2017/0328 (COD), No 13316/18 of 30 October 2018.

( 68 ) Regulation (EU) 2018/1718 of the European Parliament and of the Council of 14 November 2018 amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (OJ 2018 L 291, p. 3).

( 69 ) European Parliament legislative resolution 2018/1718 of 25 October 2018 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)).

( 70 ) Ibid., point 5.

( 71 ) In contrast to the parallel pending Case C‑743/19, Parliament v Council (Seat of the ELA), where the Parliament decided to proceed differently.

( 72 ) See above, footnote 60 of this Opinion.

( 73 ) Rawls, J.A., Theory of Justice: Revised Edition, Harvard University Press, 1999, p. 118 et seq.

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