Italy v Council (Siège de l'Agence europeenne des medicaments) (annulment - Law governing the institutions - European Medicines Agency - Judgment) [2022] EUECJ C-59/18 (14 July 2022)

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(Action for annulment – Law governing the institutions – EU bodies, offices and agencies – European Medicines Agency (EMA) – Competence to determine the location of the seat – Article 341 TFEU – Scope – Decision adopted by the Representatives of the Governments of the Member States in the margins of a Council meeting – Jurisdiction of the Court under Article 263 TFEU – Author and legal nature of the act – Absence of binding effects in the EU legal order)

ACTIONS for annulment under Article 263 TFEU, brought on 30 January 2018 and 9 March 2018,

Italian Republic, represented by G. Palmieri, acting as Agent, and by C. Colelli, S. Fiorentino and G. Galluzzo, avvocati dello Stato,

Comune di Milano, represented by M. Condinanzi, A. Neri and F. Sciaudone, avvocati,

Italian Republic, represented by G. Palmieri, acting as Agent, and by C. Colelli, S. Fiorentino and G. Galluzzo, avvocati dello Stato,

Council of the European Union, represented by M. Bauer, J. Bauerschmidt, F. Florindo Gijón and E. Rebasti, acting as Agents,

Kingdom of the Netherlands, represented by M.K. Bulterman and J. Langer, acting as Agents,

European Commission, represented by K. Herrmann, M. Konstantinidis and D. Nardi, acting as Agents,

composed of K. Lenaerts, President, A. Arabadjiev, K. Jürimäe, C. Lycourgos, E. Regan, S. Rodin, I. Jarukaitis, N. Jääskinen and J. Passer, Presidents of Chambers, J.‑C. Bonichot, M. Safjan, F. Biltgen, P.G. Xuereb, A. Kumin and N. Wahl (Rapporteur), Judges,

having regard to the written procedure and further to the hearing on 8 June 2021,

after hearing the Opinion of the Advocate General at the sitting on 6 October 2021,

1 By their applications, the Italian Republic (C‑59/18) and the Comune di Milano (Municipality of Milan, Italy) (C‑182/18) seek the annulment of the decision adopted in the margins of the 3 579th meeting of the Council, in its General Affairs formation, of 20 November 2017, in so far as that decision designated the city of Amsterdam as the new seat of the European Medicines Agency (EMA) (‘the contested decision’).

2 On 12 December 1992, the Representatives of the Governments of the Member States adopted by common agreement, on the basis of Article 216 of the EEC Treaty, Article 77 of the ECSC Treaty and Article 189 of the EAEC Treaty, the decision on the location of the seats of the institutions and of certain bodies and departments of the European Communities (OJ 1992 C 341, p. 1; ‘the Edinburgh Decision’).

3 Article 1 of the Edinburgh Decision fixed the respective seats of the European Parliament, the Council of the European Union, the European Commission, the Court of Justice of the European Union, the European Economic and Social Committee, the European Court of Auditors and the European Investment Bank.

‘The seat of other bodies and departments set up or to be set up will be decided by common agreement between the Representatives of the Governments of the Member States at a forthcoming European Council, taking account of the advantages of the above provisions to the Member States concerned, and giving appropriate priority to Member States who do not at present provide the sites for Community institutions.’

5 Article 341 TFEU provides that ‘the seat of the institutions of the Union shall be determined by common accord of the governments of the Member States’.

6 As provided in Protocol No 6 on the location of the seats of the institutions and of certain bodies, offices, agencies and departments of the European Union (‘Protocol No 6’), annexed to the EU, FEU and EAEC Treaties:

Having regard to Article 341 of the Treaty on the Functioning of the European Union and Article 189 of the Treaty establishing the European Atomic Energy Community,

Recalling and confirming the Decision of 8 April 1965, and without prejudice to the decisions concerning the seat of future institutions, bodies, offices, agencies and departments,

(d) The Court of Justice of the European Union shall have its seat in Luxembourg.

7 The European Agency for the Evaluation of Medicinal Products was established 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 (OJ 1993 L 214, p. 1). That regulation contained no provision relating to the location of the seat of that agency.

8 Pursuant to Article 1(e) of Decision 93/C 323/01 of 29 October 1993, taken by common Agreement between the Representatives of the Governments of the Member States, meeting at Head of State or 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), that agency’s seat was located in London (United Kingdom).

9 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 (OJ 2004 L 136, p. 1). By that regulation, the European Agency for the Evaluation of Medicinal Products was renamed ‘the European Medicines Agency’. That regulation contained no provision relating to the location of the seat of that agency.

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

11 On 22 June 2017, in the margins of a meeting of the European Council relating to the procedure laid down in Article 50 TEU, the Heads of State or Government of the 27 other Member States approved, on the basis of a proposal from the President of the European Council and the President of the Commission, a procedure for the adoption of a decision on the transfer to other sites of the seats of the EMA and the European Banking Authority in the context of the United Kingdom’s withdrawal from the European Union (‘the selection rules’).

12 The selection rules provided, inter alia, that that decision was to be taken on the basis of a fair and transparent decision-making process, including the organisation of a call for offers based on precise objective criteria.

13 Six criteria were laid down in paragraph 3 of the selection rules, namely (i) the assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom’s withdrawal from the European Union; (ii) the accessibility of the proposed location; (iii) the existence of adequate education facilities for the children of agency staff; (iv) appropriate access to the labour market, social security and medical care for both children and spouses; (v) business continuity, and (vi) geographical spread.

14 According to the selection rules, those criteria were established by analogy with those set out in the Common Approach set out in the annex to the Joint Statement of the European Parliament, the Council and the Commission of 19 July 2012 on decentralised agencies (‘the 2012 Joint Statement’), particular attention being paid to the fact that the EMA and the European Banking Authority had already been established and that the continuity of their activities was of paramount importance.

15 Paragraph 2 of the selection rules also provided that the decision would be taken by a voting process the outcome of which the Member States agreed in advance to respect. In particular, it was stated that, in case of a tie between the remaining offers in the third round of votes, the decision would be taken by drawing lots between the tied offers.

16 On 30 September 2017, the Commission published its assessment of the 27 offers submitted by the Member States.

17 On 31 October 2017, the Council published a note intended to supplement the selection rules on practical questions regarding voting.

18 On 20 November 2017, the Italian Republic’s offer and that of the Kingdom of the Netherlands obtained, ex aequo, the highest number of votes in the third round. After the drawing of lots organised in accordance with paragraph 2 of the selection rules, the Kingdom of the Netherlands’ offer was accepted.

19 Consequently, on the same date, the Representatives of the Governments of the Member States, by the contested decision, designated, in the margins of a meeting of the Council, the city of Amsterdam as the new seat of the EMA. The minutes and press release of that meeting stated as follows:

‘The Commission will now prepare legislative proposals reflecting today’s vote for adoption under the ordinary legislative procedure with the involvement of the European Parliament. The Council and the Commission are committed to ensuring that those legislative proposals are processed as quickly as possible in view of the urgency of the matter.’

20 On 29 November 2017, the Commission adopted 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) 735 final). The reasons for that proposal stated that ‘in the context of the United Kingdom’s notification on 29 March 2017 of its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union, the 27 other Member States, meeting in the margins of the General Affairs Council (“Article 50”), [had] selected Amsterdam, the Netherlands, as the new seat of the [EMA]’. Article 1 of that proposal provided for the insertion of an Article 71a in Regulation No 726/2004, worded as follows: ‘The [EMA] shall have its seat in Amsterdam, the Netherlands.’

21 On 14 November 2018, Regulation (EU) 2018/1718 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 (OJ 2018 L 291, p. 3) was adopted. That regulation, which was adopted on the basis of Article 114 and Article 168(4)(c) TFEU, inserted Article 71a into Regulation No 726/2004, the first subparagraph of which is worded as follows:

– by way of measures of inquiry, first, request, pursuant to Article 24 of the Statute of the Court of Justice of the European Union, the Kingdom of the Netherlands, the EMA and any other institution, body, office or agency to provide all the information necessary to report on Amsterdam’s ability, as the seat of the EMA, to meet the criteria set out and to determine whether that information corresponds with the information on which the offer is based and, secondly, to decide on any other measure of inquiry which may be considered useful for establishing the facts;

– annul the contested decision in so far as it designates Amsterdam as the new seat of the EMA and, consequently,

– in the event that the action is upheld, maintain the legal effects of the contested decision for a period necessary for the organisation of a new selection procedure.

24 By document lodged at the Court Registry on 17 April 2018, the Council raised an objection of inadmissibility pursuant to Article 151(1) of the Rules of Procedure of the Court of Justice.

25 In its observations lodged at the Court Registry on 5 June 2018, the Italian Republic contended that that objection of inadmissibility should be rejected.

26 By application lodged at the Registry of the General Court of the European Union on 30 January 2018 and registered as Case T‑46/18, the Comune di Milano brought an action against the contested decision. By order of 8 March 2018, Comune di Milano v Council (T‑46/18, not published, EU:T:2018:131), adopted pursuant to the third paragraph of Article 54 of the Statute of the Court of Justice of the European Union and Article 128 of the Rules of Procedure of the General Court, the General Court declined jurisdiction in Case T‑46/18 in order to enable the Court of Justice to rule on the action in that case, which was registered as Case C‑182/18.

– in the event that the action is upheld, maintain the legal effects of the contested decision for a period necessary for the organisation of a new selection procedure.

29 By document lodged at the Court Registry on 17 April 2018, the Council raised an objection of inadmissibility pursuant to Article 151(1) of the Rules of Procedure of the Court of Justice.

30 In its observations lodged at the Court Registry on 5 June 2018, the Comune di Milano contended, primarily, that the objection of inadmissibility should be rejected and, in the alternative, that that plea should be reserved until the ruling on the substance of the case.

31 By decisions of the President of the Court of 13 April 2018 and 18 May 2018 in Case C‑59/18 and of 17 April 2018 and 18 May 2018 in Case C‑182/18, the Kingdom of the Netherlands and the Commission were granted leave to intervene in support of the form of order sought by the Council.

32 By decisions of the President of the Court of 11 June 2018 and 1 February 2019 in Case C‑182/18, the Regione Lombardia (Region of Lombardy, Italy) and the Italian Republic were granted leave to intervene in support of the form of order sought by the Comune di Milano.

33 By order of the Vice-President of the Court of 2 July 2018, Comune di Milano v Council (C‑182/18 R, not published, EU:C:2018:524), the Comune di Milano’s application for suspension of operation of the contested decision was dismissed.

34 By decision of the Court of 18 September 2018, the objections of inadmissibility raised by the Council in Cases C‑59/18 and C‑182/18 were reserved until the ruling on the substance of the case.

35 By order of the President of the Court of 19 December 2019, Cases C‑59/18 and C‑182/18 were joined for the purposes of the remainder of the proceedings and the judgment.

36 The Council contends that the present actions are manifestly inadmissible, since the contested decision, which is, from the point of view both of form and substance, a measure taken collectively by the Representatives of the Governments of the Member States in the margins of a meeting of the Council, is not subject to a review of legality by the Court under Article 263 TFEU.

37 The Council takes the view, in the first place, that the power to determine the location of the seat of an agency of the Union does not fall within the competence of the European Union to govern a specific substantive area and, therefore, in the present case, the ordinary legislative procedure. According to the Council, the decision on the location of the seat of an agency is fundamentally different in nature from decisions governing the definition of competencies, the operating rules, or even the organisation of that agency. Such a decision is characterised by a strong political and symbolic dimension, which is not limited to the specific material field of the agency in question and which goes beyond mere considerations of economy or efficiency. This is borne out by the fact that technical criteria such as those referred to in the 2012 Joint Statement were drawn up over time to control the location of the seat of the agencies of the Union. Thus, the location of the seat of an agency of the Union is not ancillary to the decision to establish that agency and is, on the contrary, of particular importance and has its own dynamics, which are not ancillary to substantive decisions on the regulation of a given field. The Council refers in particular to the Edinburgh Decision, but also to litigation concerning the seat of the Parliament.

38 In the second place, the Council submits that the competence to determine the location of the seat of an agency of the Union lies with the Representatives of the Governments of the Member States acting by common accord. That competence is thus based on Article 341 TFEU, interpreted in the light of historical developments, the context of which that article forms part, namely Articles 340 and 342 TFEU, Protocol No 6 and Article 2 of the Edinburgh Decision, and the general practice followed. It is apparent in particular from that practice that, first, the location of the seat of an agency of the Union is the result of a legally binding decision taken by common accord of the Representatives of the Governments of the Member States. The constitutive effect of such a decision is, moreover, demonstrated by the fact that, in certain cases, the basic legislative act is silent as to the choice of seat, and that did not prevent the establishment of the agency concerned or the conclusion of the Headquarters Agreement. Secondly, the inclusion of the indication of the location of the seat in the basic legislative act establishing an agency of the Union is of purely declaratory and recognition value, as is any reference made in a legislative text to a factual element. The EU legislature cannot therefore depart from the choice already made by the Representatives of the Governments of the Member States, which is thus binding. The inclusion, in the basic legislative act, of the indication of the location of the seat is not, however, devoid of any legal significance. Apart from the fact that that indication is an important factor of legal certainty, the legislative text may, as in the present case with the insertion of Article 71a into Regulation No 726/2004 by Regulation 2018/1718, include with that indication a series of other legislative elements, both substantive and procedural, in order to supplement the purely geographical location of the seat.

39 According to the Kingdom of the Netherlands, intervening in support of the Council, the contested decision, which is an act of the Member States and not of the Council, is not subject to a review of legality by the Court under Article 263 TFEU. In the present case, the ministers who participated in the adoption of that decision acted in their capacity as representatives of their government and not as members of the Council. Referring also to the judgment of 27 November 2012, Pringle (C‑370/12, EU:C:2012:756, paragraphs 155 to 159), the Kingdom of the Netherlands submits that the Member States may entrust tasks to the institutions provided that they respect the competences of the European Union and its institutions.

40 The Commission, while endorsing the Council’s view that the contested decision is not subject to a review of legality by the Court under Article 263 TFEU, puts forward a significantly different line of argument. It takes the view that the power to determine the location of the seat of agencies of the Union lies solely with the EU legislature acting in accordance with the ordinary legislative procedure and therefore considers that, in the present case, the contested decision, which is not part of EU law and which is purely political, has no legally binding consequence.

41 The Commission points out that it is true that Article 341 TFEU has inspired the practice hitherto followed by the institutions in determining the seat of agencies of the Union. In the vast majority of cases, the Commission does not specify the location of the seat of those agencies in its legislative proposals relating to their establishment pending the political decision of the Representatives of the Governments of the Member States.

42 However, the Commission remains free to depart from that practice, as it has already done in various circumstances, by including in its legislative proposals an indication of the location of the seat of certain agencies of the Union. Similarly, whilst the EU legislature usually complies with the decision of the Representatives of the Governments of the Member States, it is not legally obliged to do so. In the present case, during the debate on the proposal for a regulation referred to in paragraph 20 above, the designation of the city of Milan as the location of the seat of the EMA was rejected after it had been the subject of a specific discussion. That fact proves that, where necessary, the possibility of departing from the political decision of the Representatives of the Governments of the Member States is not merely theoretical. If the act adopted at the end of the ordinary legislative procedure had established the seat of the EMA in a location other than that indicated in the contested decision, no rule of EU law would have been infringed by non-compliance with that decision.

43 Furthermore, the Common Approach annexed to the 2012 Joint Statement does not establish that the Council may alone decide the location of the seat of an agency of the Union. Although paragraph 6 of that Common Approach contains a reference to past practice, consisting of making a political choice, that point has neither legislative scope nor legally binding effect. It has the objective, not of determining who decides on the seat of agencies of the Union and in accordance with which procedures, but of providing how that choice must be made, that is to say, before the end of the ordinary legislative procedure, on the basis of objective criteria and in a transparent manner.

44 As regards the circumstances surrounding the adoption of the contested decision, the Commission points out that they indicate that that decision emanates from representatives of 27 of the 28 Member States, at the time, of the European Union, so that that decision, which was adopted without the involvement of all the constituent bodies of the Council, cannot be attributed to it. The fact that the Council made its infrastructure available to the Member States is not sufficient to attribute that decision to it.

45 The Italian Republic maintains that, although the contested decision formally appears to have been adopted by the Conference of Representatives of the Governments of the Member States, it must be regarded as being attributable to the Council. It notes that, according to the Court’s case-law, it is not sufficient for an act to be classified as a ‘decision of the Member States’ for it to be excluded from review under Article 263 TFEU. According to the Italian Republic, which refers to paragraph 14 of the judgment of 30 June 1993, Parliament v Council and Commission (C‑181/91 and C‑248/91, EU:C:1993:271), it remains to be determined whether, having regard to its content and all the circumstances in which it was adopted, it is not in reality a decision of the Council.

46 In the present case, both the content of the contested decision and the circumstances of its adoption allow that decision to be classified as an act of the Council.

47 First, the power to establish the seat of the EMA, a body established by secondary EU legislation on the basis of provisions currently corresponding to Article 114 and Article 168(4)(c) TFEU, is undoubtedly a competence of the European Union. That is apparent in particular from the 2012 Joint Statement, by which the Parliament, the Council and the Commission agreed that the choice of the seat of the agencies of the Union might fall within the competence of the Council or the Member States. To conclude that the actions brought against the contested decision are inadmissible would amount to circumventing the Court’s jurisdiction and to removing certain Council decisions from review by the EU Courts whenever the Member States agree that a decision falling within the competences and procedures of the European Union is an intergovernmental decision.

48 Secondly, the Italian Republic submits that the conclusion that the contested decision was adopted in an area which fundamentally falls within EU law is supported by the specific arrangements for its adoption. It points out, first of all, that, at the time of that adoption, not only were the Council’s premises used but also its internal functional structures, such as the General Secretariat, the Legal Service, the rotating Estonian Presidency and the Committee of Permanent Representatives (Coreper). The Italian Republic states, next, that the voting and decision-making procedures were those laid down in the selection rules approved at the meeting of 22 June 2017 and in the note of 31 October 2017, which confirms the participation of the bodies of the Union throughout the procedure for designating the new seat of the EMA. Lastly, the majority rule adopted in the present case for the purposes of establishing the new seat of the EMA is a typical decision-making process for international organisations, whereas, conversely, in the case of the adoption of an intergovernmental decision attributable to the Member States, it is the rule of unanimity or the ‘common accord’ which prevails.

49 The Italian Republic states that, contrary to what the Council claims, Article 341 TFEU, which provides that ‘the seat of the institutions of the Union shall be determined by common accord of the governments of the Member States’, does not apply to decisions concerning the seat of agencies of the Union. The contested decision thus falls within the exclusive competence of the European Union, as the Commission expressly stated in its proposal for a regulation referred to in paragraph 20 above, and, consequently, within the Court’s power of review.

50 The Comune di Milano, supported by the Regione Lombardia, puts forward arguments similar to those of the Italian Republic.

51 The Comune di Milano submits, first of all, that, unless a purely formalistic approach is taken, the contested decision must be regarded as attributable to the Council, and in particular to its presidency, which was entrusted, in the context of the procedure for the relocation of the EMA, with the role of adjudicator enabling it to compensate for the inability of the Member States to form a majority and, therefore, to take a decision in the event of a tie in the votes, including by the drawing of lots.

52 Next, the Comune di Milano states that the attribution of the contested decision to the Council is also due to the fact that, in the present case, it was a majority voting rule and not unanimity which was used for the purpose of determining the location of the new seat of the EMA.

53 Furthermore, the Comune di Milano considers that, even if it were concluded that the contested decision must be imputed to the Member States, it should nevertheless be subject to review by the Court. It explains that, just as an act adopted by Coreper must be attributed to the Council, acts of the EU Presidency must be attributed to the Council when it exercises formally and substantively the power to adopt the measure in question. The fact that the act is subsequently confirmed in the margins of the Council by the Member States cannot exempt it from review by the Court, since that confirmation brings the decision-making process to an end and renders the act final. More fundamentally, it should be possible for acts of the Council’s internal bodies to be subject to a review of legality in accordance with the case-law of the Court (judgments 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, and of 20 September 2016, Mallis and Others v Commission and ECB, C‑105/15 P to C‑109/15 P, EU:C:2016:702).

54 Finally, the Comune di Milano refers to the explanatory memorandum of the proposal for a regulation referred to in paragraph 20 above, in which the Commission stated that ‘the issue of the location of the seat of the Agency falls within the exclusive competence of the Union’, which confirms, from its point of view, that the contested decision is indeed an act of the Council adopted in the exercise of an exclusive competence.

55 In addition, the Comune di Milano criticises the formality of the approach advocated by the Council.

56 First, it points out that the decisive criterion for identifying the author of an act is whether, having regard to its content and the circumstances of its adoption, that act is a decision of the Council. Indeed, it follows from all the circumstances in which the contested decision was adopted and from its content that that decision cannot be classified as a political and intergovernmental act which falls outside the review of legality established by the Treaties. The Comune di Milano points out, in particular, that that decision was not only drafted by the Administrative Services of the Council, but that it was adopted by the acting Council Presidency. Similarly, the choice was made not only to derogate from the principle of unanimity, but also to proceed by the drawing of lots, which shows that the contested decision is not based on any discretionary assessment or weighing up of the interests involved, which are characteristic elements of a purely political decision.

57 Secondly, the substantive arguments put forward by the Council in that context are unfounded. First of all, Article 341 TFEU, which provides that a decision as to the location of the seat of the institutions is to be taken ‘by common accord of the governments of the Member States’, precludes a vote being taken in the area covered by that article. Next, as is apparent in particular from the proposal for a regulation referred to in paragraph 20 above, the choice of the location of the seat of the EMA falls within the exclusive competence of the European Union. Such a power cannot be exercised by means of an act of the Member States. Moreover, Article 341 TFEU cannot be interpreted broadly as referring to agencies of the Union. In the opinion of the Comune di Milano, recent practice concerning the choice of the seat of those agencies shows a tendency towards transferring the responsibility for that choice from the Member States to the Council, or to the Council and the European Parliament. Moreover, the Council’s argument that the contested decision is attributable to the Member States on the ground that the seat of the EMA had previously been chosen by an act adopted by the Member States is also wholly unfounded. Lastly, the Comune di Milano refers to other formal matters which confirm the imputability to the Council of that decision, namely (i) the recording and dissemination of the acts and records of the Council itself and (ii) the information documents circulated by the EMA and the Netherlands authorities.

58 Thirdly, the Comune di Milano submits, in the alternative, that acts adopted by the acting Council Presidency should be subject to review by the Court. It considers that, in so far as the contested decision puts an end to the procedure for selecting the new seat of the EMA, it is final and must be subject to judicial review. Moreover, the action of the Council’s internal bodies in the adoption of that decision should, in any event, be subject to review by the Court, since the EU institutions have an obligation to comply with the Charter of Fundamental Rights of the European Union even when they act outside the institutional framework of the European Union.

59 The European Union is a union based on the rule of law which has been provided by the FEU Treaty with a complete system of legal remedies and procedures designed to enable the Court to review the legality of acts of the institutions (see, to that effect, judgments of 23 April 1986, Les Verts v Parliament, 294/83, EU:C:1986:166, paragraph 23; of 3 September 2008, Kadi and Al Barakaat International Foundation v Council and Commission, C‑402/05 P and C‑415/05 P, EU:C:2008:461, paragraph 281; and of 3 June 2021, Hungary v Parliament, C 650/18, EU:C:2021:426, paragraph 34 and the case-law cited).

60 As regards the action for annulment provided for in Article 263 TFEU, it is available in the case of all measures adopted by the institutions, bodies, offices and agencies of the Union, whatever their nature or form, which are intended to have binding legal effects (see, to that effect, judgments of 31 March 1971, Commission v Council, 22/70, EU:C:1971:32, paragraph 42, and of 3 June 2021, Hungary v Parliament, C‑650/18, EU:C:2021:426, paragraph 37 and the case-law cited).

61 That said, in the context of an action for annulment under Article 263 TFEU, the EU Courts have jurisdiction only to review the legality of acts attributable to the institutions, bodies, offices and agencies of the Union. It follows therefrom, in particular, that acts adopted by Representatives of the Governments of the Member States acting, not in their capacity as members of the Council or of the European Council, but as representatives of their governments, and thus collectively exercising the powers of the Member States, are not subject to judicial review by the EU Courts (see, to that effect, judgment of 30 June 1993, Parliament v Council and Commission, C‑181/91 and C‑248/91, EU:C:1993:271, paragraph 12, and order of 16 June 2021, Sharpston v Council and Representatives of the Governments of the Member States, C‑685/20 P, EU:C:2021:485, paragraph 46).

62 However, it is not enough that the decision which is the subject of an action should be formally presented as being a decision of the Member States for that act to be excluded from the review of legality established by Article 263 TFEU. In order for such an act to be excluded from review, it must also, having regard to its content and all the circumstances in which it was adopted, not in reality be a decision of the Council (see, to that effect, judgment of 30 June 1993, Parliament v Council and Commission, C‑181/91 and C‑248/91, EU:C:1993:271, paragraph 14).

63 In the present case, the contested decision must be assessed in the light of the legal framework applicable to the location of the seat of the bodies, offices and agencies of the Union. In that regard, the parties disagree as to whether Article 341 TFEU, under which the seat of the ‘institutions’ is to be determined ‘by common accord of the Governments of the Member States’, may properly be relied on as the basis for decisions determining the seat of the bodies, offices and agencies of the Union.

64 On the one hand, the Council contends that Article 341 TFEU must be interpreted broadly, as referring by extension to the bodies, offices and agencies of the Union, with the result that the competence to determine the seat of such a body, office or agency lies solely with the Representatives of the Governments of the Member States acting by common accord. It follows that the contested decision, as an act emanating the Member States and not from the Council, is not subject to the Court’s review of legality under Article 263 TFEU.

65 On the other hand, the applicants submit that the contested decision is necessarily imputable to the Council and cannot, therefore, escape the review of legality carried out by the Court.

66 It is therefore necessary, in the first instance, to determine whether the decision on the designation of the seat of a body, office or agency of the Union must be taken by the Member States, in accordance with the rule set out in Article 341 TFEU, or whether it must be taken by the EU legislature, pursuant to the substantive legal basis applicable to the area in which the body, office or agency in question is called upon to intervene.

Competence to determine the location of the seat of the bodies, offices and agencies of the Union

67 According to settled case-law of the Court, the interpretation of a provision of EU law requires that account be taken not only of its wording and the objectives it pursues, but also of its context. The origins of a provision of EU law may also provide information relevant to its interpretation (see, to that effect, judgment of 10 December 2018, Wightman and Others, C‑621/18, EU:C:2018:999, paragraph 47 and the case-law cited).

68 It is, therefore, necessary to examine, on the basis of those methods of interpretation, whether Article 341 TFEU applies to decisions determining the seat of the bodies, offices and agencies of the Union.

69 In the first place, as regards the wording of Article 341 TFEU, it refers only to the ‘institutions of the Union’. In accordance with Article 13(1) TEU, the concept of ‘institutions’ refers to a precise list of entities which does not include the bodies and offices and, in particular, the agencies of the Union.

70 In the second place, as regards the context of Article 341 TFEU, it must be pointed out, first of all, as observed by the Advocate General in point 94 of his Opinion, that a number of provisions of the Treaties have been amended by the Treaty of Lisbon in order to include an express reference to the ‘bodies, offices and agencies of the Union’, which has had the effect of expressly distinguishing between, on the one hand, the institutions of the Union expressly referred to in Article 13(1) TEU and, on the other, the bodies, offices and agencies of the Union. Thus, while some provisions of the FEU Treaty refer only to the institutions of the Union, other provisions of the FEU Treaty, such as Articles 15, 16, 123, 124, 127, 130, 228, 263, 265, 267, 282, 298 and 325, refer more broadly to the institutions, bodies, offices and agencies of the Union. That is the case in particular, as regards the Court’s jurisdiction, with Articles 263, 265 and 267 TFEU.

71 It is clear that the wording of Article 341 TFEU, which refers only to the ‘institutions’, corresponds to that of the provisions which preceded that article, namely Article 216 of the EEC Treaty (subsequently Article 216 of the EC Treaty, which in turn became Article 289 EC).

72 The fact, put forward by the Council, that the provisions of Part Seven of the FEU Treaty, of which Article 341 TFEU forms part, entitled ‘General and Final Provisions’, refer to the ‘institutions’ cannot therefore be interpreted – even though, as is clear from paragraph 70 above, the EU Treaty draws a clear distinction between the institutions of the Union, on the one hand, and the bodies, offices and agencies of the Union, on the other – as an expression of the intention of the framers of the Treaties to confer a broad understanding on the concept of ‘institutions’, in that that concept would encompass not only the entities listed in Article 13(1) TEU, but also the bodies, offices and agencies of the Union established by or under the Treaties and intended to contribute to the achievement of the European Union’s objectives. This must all the more be so since the EU Treaty and the TFEU constitute a unitary constitutional basis for the European Union by reason of the third paragraph of Article 1 TEU and Article 1(2) TFEU, with the result that the definition of the concept of ‘institutions’ in Article 13(1) TEU and the distinction between those institutions, on the one hand, and the bodies, offices and agencies of the Union, on the other, must apply transversely and uniformly in both treaties.

73 Nor can the broad interpretation given by the Court to the concept of ‘institutions’, within the meaning of the second paragraph of Article 340 TFEU, be determinative, that provision stating that ‘in the case of non-contractual liability, the Union shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its institutions or by its servants in the performance of their duties’.

74 Although the Court has held that the term ‘institutions’ within the meaning of that provision encompasses not only the institutions of the Union listed in Article 13(1) TEU but also all the bodies, offices and agencies of the Union that have been established by or under the Treaties and are intended to contribute to the achievement of the European Union’s objectives (judgment of 16 December 2020, Council and Others v K. Chrysostomides & Co. and Others, C‑597/18 P, C‑598/18 P, C‑603/18 P and C‑604/18 P, EU:C:2020:1028, paragraph 80 and the case-law cited), it expressly relied, in order to establish that case-law, on the fact, first, that the bodies, offices and agencies of the Union established by or under the Treaties are intended to contribute to the achievement of the European Union’s objectives and, secondly, that it would be contrary to the intention of the framers of the Treaties if, when it acts through a body, office or agency, the European Union could escape the consequences of the provisions of the Treaties governing the European Union’s non-contractual liability (see, to that effect, judgment of 2 December 1992, SGEEM and Etroy v EIB, C‑370/89, EU:C:1992:482, paragraphs 13 to 16).

75 Thus, the broad interpretation given by the Court to the concept of ‘institutions’, for the purposes of applying the second paragraph of Article 340 TFEU, meets the need, justified by the general principles common to the laws of the Member States expressly referred to in that provision, to prevent the European Union from being able to avoid the application of the system of non-contractual liability under Article 268 TFEU, read in conjunction with the second paragraph of Article 340 TFEU, and the resulting judicial review by the Court, where the European Union acts through a body, office or agency of the Union other than the institutions listed in Article 13(1) TEU (see, by analogy, judgment of 2 December 1992, SGEEM and Etroy v EIB, C‑370/89, EU:C:1992:482, paragraphs 14 and 16). This must all the more be so since, as the Advocate General stated in point 100 of his Opinion, the concept of ‘servants’ in the second paragraph of Article 340 TFEU encompasses from a functional point of view all the staff working for the European Union, whether in the institutions or in the bodies, offices and agencies of the Union.

76 Consequently, the interpretation given to the concept of ‘institutions’ within the meaning of the second paragraph of Article 340 TFEU, which governs the extent of the non-contractual liability of the European Union, cannot properly be relied on for the purposes of defining by analogy the scope of Article 341 TFEU, relating to the extent of the powers reserved to the Member States under the Treaties.

77 Nor can the Council properly rely on the concept of ‘institutions’ in Article 342 TFEU, according to which ‘the rules governing the languages of the institutions of the Union shall, without prejudice to the provisions contained in the Statute of the Court of Justice of the European Union, be determined by the Council, acting unanimously by means of regulations’. As the Advocate General stated in point 98 of his Opinion, the term ‘institutions’, within the meaning of Article 342 TFEU, need not necessarily be interpreted as including the bodies, offices and agencies of the Union, since the language regime of a body, office or agency of the Union can be different from that in force in the institutions of the Union.

78 As regards Protocol No 6, although, as the Council contends, that protocol determines not only the seat of the institutions of the Union but also that of certain bodies, offices and agencies of the Union, including Europol, and refers to Article 341 TFEU, it does not, however, provide that the seats of bodies, offices and agencies of the Union must be determined collectively by the Member States in accordance with the principle laid down in that article. In that regard, it is important to note that the common feature of those bodies, offices and agencies of the Union in question is that they were established by the Member States, whereas that is not the case with an agency of the Union such as the EMA, which was established, on the basis of the founding Treaties, by the EU legislature. Thus, it cannot be inferred from that protocol that the Member States intended to apply, directly or by analogy, the principle laid down in Article 341 TFEU to the determination of the seat of all the bodies, offices and agencies of the Union.

79 As the Advocate General observed in point 112 of his Opinion, the adoption of a specific protocol shows, on the contrary, that the Member States considered that their collective decision as to the determination of the seat of certain bodies, offices and agencies of the Union exhaustively listed had to be specifically enshrined in primary law in order to produce legal effects in EU law.

80 As regards the express reference in Protocol No 6 to Article 341 TFEU, this can be explained by the fact that that protocol refers primarily to the institutions mentioned in Article 13(1) TEU.

81 On the other hand, it is true, as is apparent from Article 2 of the Edinburgh Decision, that the Representatives of the Governments of the Member States expressed the wish to reserve to themselves decisions concerning the seats of bodies, offices and agencies of the Union in the same way that they are expressly and clearly authorised by Article 341 TFEU to establish the seats of the institutions. Furthermore, at the intergovernmental conference which led to the adoption of the Treaty of Amsterdam, the text of the Edinburgh Decision was reproduced as a protocol annexed to the EU, EC, ECSC and EAEC Treaties, now Protocol No 6, annexed to the EU, FEU and EAEC Treaties.

82 Nevertheless, first, the sole article of that protocol fixes, in terms comparable to those of Article 1 of the Edinburgh Decision, the seat only of institutions, bodies, offices or agencies of the Union set up by the Member States. Secondly, although the Court recognised that that decision had binding legal force, in the judgment of 1 October 1997, France v Parliament (C‑345/95, EU:C:1997:450), to which judgment it referred in other subsequent judgments (see, to that effect, judgments of 13 December 2012, France v Parliament, C‑237/11 and C‑238/11, EU:C:2012:796, paragraphs 36 to 42, and of 2 October 2018, France v Parliament (Exercise of budgetary powers), C‑73/17, EU:C:2018:787, paragraph 33), Article 2 of that decision cannot lead to an interpretation of Article 341 TFEU that would run counter to its clear wording.

83 The Council also relies, as a contextual element, on previous institutional practice relating to the determination of the seat of bodies, offices and agencies of the Union and maintains that that practice enjoys ‘institutional recognition’ by means of the 2012 Joint Statement and the common approach annexed thereto.

84 However, it is clear from the information brought to the Court’s attention in the context of the present cases that the alleged practice is far from being generalised. The procedures followed with a view to designating the seat of the bodies, offices and agencies of the Union have either been carried out by the Member States alone or have, to varying degrees and on varying grounds, involved the institutions of the Union in their capacity as participants in the legislative procedure or not.

85 Assuming, however, that it were possible, as the Council maintains, to identify an established and consistent previous practice whereby the seats of the bodies, offices and agencies of the Union were systematically determined on the basis of a political choice made by the Representatives of the Governments of the Member States alone, the interpretation of Article 341 TFEU that the Council advocates on the basis of that practice could not enjoy any ‘institutional recognition’ by means of the 2012 Joint Statement and the common approach annexed thereto. That statement, as made clear in the fifth paragraph thereof, is not legally binding and does not, moreover, contain any recognition of any reservation of competence on the part of the Member States as regards determining the seat of the bodies, offices and agencies of the Union.

86 In any event, such a practice, which would run counter to the rules of the FEU Treaty and, in particular, Article 341 TFEU, by extending, notwithstanding its clear wording, the scope of that article to the location of the seat of the bodies, offices and agencies of the Union, could not create a precedent binding on the institutions (see, to that effect, judgment of 6 May 2008, Parliament v Council, C‑133/06, EU:C:2008:257, paragraph 60 and the case-law cited).

87 In the third and last place, as regards the objective of Article 341 TFEU, this consists in preserving the decision-making powers of the Member States in determining the seat of the institutions of the Union only. Contrary to the position defended by the Council at the hearing, an interpretation of that article to the effect that it does not apply to bodies, offices and agencies of the Union cannot have the effect of completely negating its effectiveness, as the Advocate General observed in point 138 of his Opinion. While it is true that the seat of the institutions of the Union is already determined by primary law, in this case by Protocol No 6, Article 341 TFEU nevertheless remains relevant to any possible future decision modifying the seat of an existing institution or determining the seat of a new institution.

88 In that context, it must be borne in mind that, unlike the institutions of the Union, the establishment and functions of which are, because of their constitutional importance, provided for by the Treaties themselves, the bodies, offices and agencies of the Union, such as the EMA, the object of which is the achievement of the aims of a given EU policy, are not as a general rule established by the Treaties. In those circumstances, their establishment, since it does not derive from primary law, must result from an act of secondary legislation adopted on the basis of the substantive provisions implementing the EU policy in which the body, office or agency concerned is involved and in accordance with the procedures laid down by those provisions.

89 In the absence of further details in that regard in the Treaties, it is likewise for the EU legislature, in accordance with the procedures laid down by the substantively relevant provisions of the Treaties, to determine the seat of a body, office or agency of the Union which it has itself established by an act of secondary legislation adopted on the basis of those provisions, in the same way as it has competence under those provisions to define the powers, organisation and mode of operation of that body, office or agency.

90 The decision on the location of the seat of a body, office or agency of the Union, such as an EU agency, is therefore, contrary to the Council’s arguments, consubstantial with the decision on its establishment. The same applies to a decision on the relocation of the seat of such an agency.

91 Admittedly, the determination of the location of the seat of a body, office or agency of the Union may take account of political considerations, such as the need, in locating bodies, offices or agencies of the Union, to ensure a certain geographical balance or to favour Member States which do not yet host the seat of a body, office or agency of the Union.

92 However, the political nature of the decision determining the location of the seat of such a body, office or agency of the Union is not in itself such as to justify that decision falling outside the competence of the EU legislature, which is indeed regularly called upon to make political choices in the exercise of the European Union’s competences (see, to that effect, judgment of 7 September 2016, Germany v Parliament and Council, C‑113/14, EU:C:2016:635, paragraph 55).

93 Moreover, such a decision must primarily ensure that the tasks entrusted to the body, office or agency of the Union concerned are carried out with a view to achieving the objectives of a given policy.

94 Nor can the Court accept the argument that linking the determination of the seat of a body, office or agency of the Union to the material basis on which that body, office or agency is established is likely, depending on the relevant legal basis, to result in that determination being subject to a qualified majority vote in the Council, and not to a decision taken by common accord of the Representatives of the Governments of the Member States, while making the determination an element of compromise in the context of the legislative debate.

95 As has been pointed out in paragraph 92 above, the fact that the decision determining the location of the seat of a body, office or agency of the Union may have an important political dimension, inasmuch as it must reflect, inter alia, considerations relating to geographical balance, does not preclude that decision from being taken by the EU legislature in accordance with the procedures laid down by the substantively relevant provisions of the Treaties, since that political dimension may in that respect constitute a factor which the EU legislature can take into account in exercising its discretion. It should also be noted that since the EU legislative process is guided, under the second paragraph of Article 1 TEU in conjunction with Article 10(3) TEU, by the principle of transparency with regard to the citizen, recourse to that process is liable to strengthen the democratic foundation of a decision designating the location of the seat of a body, office or agency of the Union, such as the EMA.

96 In addition, and more fundamentally, the fact that a decision, such as that determining the location of the seat of a body, office or agency of the Union, is politically sensitive cannot lead to the powers conferred by the Treaties on the institutions of the Union being modified, nor can it remove the exercise of those powers from the legislative procedures laid down by the Treaties. The determination of the scope of a provision of the Treaties governing a substantive competence of the European Union cannot therefore depend on considerations relating to the politically sensitive nature of the matter concerned or to the concern to ensure the effectiveness of an action.

97 It follows from all those considerations, and in particular from the wording of Article 341 TFEU, that that provision cannot be interpreted as extending to the designation of the location of the seat of a body, office or agency of the Union such as the EMA.

98 In those circumstances, the competence to determine the location of the seat of that agency lies not with the Member States but with the EU legislature, which must act to that end in accordance with the procedures laid down by the substantively relevant provisions of the Treaties, in this case Article 114 and Article 168(4) TFEU, which provide for recourse to the ordinary legislative procedure.

99 It is in the light of that conclusion that it is necessary to adjudicate, in the second instance, on the Court’s jurisdiction to rule on the present actions.

The author of the contested decision and the jurisdiction of the Court under Article 263 TFEU

100 It is necessary, in the first place, to ascertain whether the contested decision, which was taken in the margins of a meeting of the Council by the Conference of the Representatives of the Governments of the Member States, is attributable to those representatives.

101 As regards the content of the contested decision, it follows from its title and from the minutes of the Council meeting of 20 November 2017, referred to in paragraph 19 above, that that decision is an act of the Heads of State or Government of 27 Member States adopted in the margins of a Council meeting following an intergovernmental procedure. That analysis is borne out by the statement in the Commission’s proposal of 29 November 2017, referred to in paragraph 20 above, that that proposal seeks to give effect, in the light of the notification given on 29 March 2017 by the United Kingdom of its intention to leave the European Union, to the choice of the city of Amsterdam as the location of the new seat of the EMA by ‘the 27 other Member States, meeting in the margins of the General Affairs Council’.

102 The conclusion that the contested decision must be imputed to the Representatives of the Governments of the Member States and not to the Council is also supported by the subsequent adoption of Regulation 2018/1718, since it was only after the adoption of that decision that the Council, in its capacity as co-legislator with the Parliament, participated in the ordinary legislative procedure, in order to insert, by that regulation, the reference to the seat of the EMA in Regulation No 726/2004 establishing that agency.

103 As regards the circumstances in which the contested decision was adopted, it should be noted that the participation of institutions of the Union in the process which led to the adoption of that decision, in particular that of the Commission, by its assessment of the offers, and that of the Council, by its chairmanship of the meeting of 20 November 2017 and by the making available of its premises and internal functional structures, such as the General Secretariat, does not support the conclusion that that decision is imputable to the Council rather than to the Member States.

104 The adoption of an act on the premises or with the assistance of an institution of the Union does not in itself confer jurisdiction on the Court to assess the legality of that act (see, by analogy, judgment of 22 March 1990, Le Pen, C‑201/89, EU:C:1990:133, paragraphs 11 and 16).

105 The contested decision cannot therefore, either by its content or by the circumstances in which it was adopted, be classified as an act of the Council. On the contrary, that decision constitutes an act taken collectively and by common accord by the Representatives of the Governments of the Member States.

106 In the second place, it should be borne in mind that the relevant criterion used by the Court to exclude the jurisdiction of the EU Courts to hear and determine an action brought against acts adopted by the Representatives of the Governments of the Member States is solely that relating to their author, irrespective of their binding legal effects (order of 16 June 2021, Sharpston v Council and Representatives of the Governments of the Member States, C‑685/20 P, EU:C:2021:485, paragraph 47).

107 The applicants’ argument that in the present case the authors of the acts to which Article 263 TFEU refers, namely the institutions, bodies, offices and agencies of the Union, should be interpreted broadly in order to consider that the contested decision was adopted by an institution, body, office or agency of the Union within the meaning of that article, or, at the very least, to treat the present actions like actions brought against a Council decision, cannot therefore be upheld without contravening the clear wording of that article (see, to that effect, order of 16 June 2021, Sharpston v Council and Representatives of the Governments of the Member States, C‑685/20 P, EU:C:2021:485, paragraph 48).

108 Such an interpretation would also conflict with the intention of the framers of the Treaties, reflected in Article 263 TFEU – whose scope is limited solely to acts of EU law adopted by the institutions, bodies, offices and agencies of the Union – to remove acts of Member States from review by the EU Courts.

109 However, although the contested decision is to be regarded as a measure adopted by the Member States alone, thus falling outside the scope of the review of legality provided for in Article 263 TFEU, it cannot be treated in the same way as a decision taken under Article 341 TFEU, since, as is apparent from the considerations set out in paragraphs 67 to 97 above, that article must be interpreted as referring exclusively to the determination of the seat of the institutions referred to in Article 13(1) TEU, and not to the determination of the seat of the bodies, offices and agencies of the Union.

110 As the Advocate General observed in point 166 of his Opinion, a decision, like the contested decision, which has been taken by the Member States in an area in which the Treaties do not provide for their action is deprived of any binding legal effects under EU law. The fact that one or more institutions of the Union have played a certain role in the procedure leading to the adoption of that decision does not alter the nature of the decision, which falls outside the EU legal order (see, by analogy, 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, paragraph 54).

111 In that context, it is for the EU legislature, for reasons of both legal certainty and effective judicial protection, to adopt, in accordance with the procedures laid down in the substantively relevant provisions of the Treaties, an act of the European Union ratifying or, on the contrary, departing from the political decision adopted by the Member States; only that act of the EU legislature is capable of producing binding legal effects under EU law and, in a context such as that of the present case, that act must necessarily precede any measure for the actual implementation of the new location of the seat of the agency concerned.

112 Thus, in the present case, as regards the location of the new seat of the EMA, the only legally binding provision which falls within the scope of EU law is Article 71a of Regulation No 726/2004, inserted in that regulation by Regulation 2018/1718.

113 It follows from all the foregoing considerations that the contested decision is not an act of the Council but an act of a political nature without any binding legal effects, taken by the Member States collectively, with the result that it cannot be the subject of an action for annulment under Article 263 TFEU.

114 Consequently, and without it being necessary to rule on the request for measures of inquiry made by the Italian Republic, the actions brought by the Italian Republic and the Comune di Milano must be dismissed as being directed against an act the lawfulness of which the Court does not have jurisdiction to review on the basis of Article 263 TFEU.

115 Under Article 138(1) of the Rules of Procedure of the Court of Justice, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

116 According to Article 138(3) of the Rules of Procedure, where each party succeeds on some and fails on other heads, the parties must bear their own costs. However, if it appears justified in the circumstances of the case, the Court may order that one party, in addition to bearing its own costs, pay a proportion of the costs of the other party.

117 In the present case, characterised by the fact that the circumstances surrounding the adoption of the contested decision are distinguished by divergent practice and interpretations as to the question of decision-making competence in relation to the location of the seats of the bodies and agencies of the Union, it appears justified to order that each of the main parties, namely the Italian Republic, the Comune di Milano and the Council, bear their own costs.

118 In accordance with Article 140(1) of the Rules of Procedure, the Regione Lombardia, the Kingdom of the Netherlands and the Commission, as interveners, must bear their own costs.

2. Orders the Italian Republic, the Comune di Milano and the Council of the European Union to bear their own costs;

3. Orders the Regione Lombardia, the Kingdom of the Netherlands and the European Commission to bear their own costs.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Italy v Council (Siège de l'Agence europeenne des medicaments) (annulment - Law governing the institutions - European Medicines Agency - Judgment) [2022] EUECJ C-59/18 (14 July 2022) URL: http://www.bailii.org/eu/cases/EUECJ/2022/C5918.html Cite as: EU:C:2022:567, [2022] EUECJ C-59/18, [2023] 1 CMLR 9, ECLI:EU:C:2022:567

Court of Justice of the European Communities (including Court of First Instance Decisions)