(Medicinal products for human use – Initiation, under Article 30 of Directive 2001/83/EC, of the procedure under Article 32 of that directive – Application for annulment – Measure against which an action may be brought – Preparatory measure – Inadmissible)

Order of the Court of First Instance (Fourth Chamber), 2 June 2004

Summary of the Order

Actions for annulment – Actionable measures – Concept – Measures producing binding legal effects – Preparatory measures – Decision of the Commission to refer a matter to the Committee for Proprietary Medicinal Products for a reasoned opinion – Measures constituting a preliminary stage in a consultative procedure – Excluded

(Art. 230 EC; European Parliament and Council Directive 2001/83, Art. 30)

Only measures which produce binding legal effects capable of affecting an applicant’s interests by bringing about a significant change in his legal position are acts or decisions against which an action for annulment may be brought under Article 230 EC. In the case of acts or decisions adopted by a procedure involving several stages, and particularly where they are the culmination of an internal procedure, it is only those measures which definitively determine the position of the institution upon the conclusion of that procedure which are open to challenge, and not intermediate measures whose purpose is to prepare for the final decision. It would be otherwise only if the acts or decisions adopted in the course of the preparatory proceedings not only bore all the legal characteristics of measures against which action may be brought, but in addition were themselves the culmination of a special procedure distinct from that intended to permit the institution to take a decision on the substance of the case.

Therefore, the decision of the Commission to refer a matter to the Committee for Proprietary Medical Products under Article 30 of Directive 2001/83 setting out a Community code relating to medicinal products for human use in order to obtain a reasoned opinion, such as that on harmonising the summaries of a product’s characteristics, is not an actionable measure. Such a decision does not definitively determine the position of the institution, any more than it represents the culmination of a special procedure distinct from that intended to result in a decision on that harmonisation. The measure does no more than set in motion a consultative procedure, and merely represents a preliminary stage in that procedure.

(see paras 21-23, 26)

ORDER OF THE COURT OF FIRST INSTANCE (Fourth Chamber) 2 June 2004 (1)

(Medicinal products for human use – Initiation, under Article 30 of Directive 2001/83/EC, of the procedure under Article 32 of that directive – Application for annulment – Measure against which an action may be brought – Preparatory measure – Inadmissible)

In Case T-123/03,

Pfizer Ltd, established in Sandwich, Kent (United Kingdom), represented by D. Anderson QC, K. Bacon, Barrister, I. Dodds-Smith and T. Fox, Solicitors,

applicant,

Commission of the European Communities, represented by H. Støvlbaek and X. Lewis, acting as Agents, with an address for service in Luxembourg,

defendant,

APPLICATION for the annulment of the Commission Decision of 6 January 2003 initiating a referral to the European Agency for the Evaluation of Medicinal Products (EMEA) in relation to Lopid under Article 30 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67),

THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Fourth Chamber),

composed of: H. Legal, President, V. Tilli and M. Vilaras, Judges,

Registrar: H. Jung,

makes the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ 2012 L 26, p. 1), as amended by Directive 2014/52/EU of the European Parliament and of the Council of 16 April 2014 (OJ 2014 L 124, p. 1) (‘Directive 2011/92’).

2 The request has been made in proceedings between, on the one hand, Waltham Abbey Residents Association and, on the other hand, An Bord Pleanála (Planning Board, Ireland; ‘the Board’), Ireland and the Attorney General (Ireland), concerning authorisation granted by the Board for a strategic residential housing development.

Legal context

European Union law

Directive 2011/92

Recitals 7 to 9 of Directive 2011/92 state:

‘(7) Development consent for public and private projects which are likely to have significant effects on the environment should be granted only after an assessment of the likely significant environmental effects of those projects has been carried out. …

(8) Projects belonging to certain types have significant effects on the environment and those projects should, as a rule, be subject to a systematic assessment.

(9) Projects of other types may not have significant effects on the environment in every case and those projects should be assessed where the Member States consider that they are likely to have significant effects on the environment.’

Article 2(1) of that directive provides:

‘Member States shall adopt all measures necessary to ensure that, before development consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects on the environment. Those projects are defined in Article 4.’

Under Article 3(1) of that directive:

‘The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case, the direct and indirect significant effects of a project on the following factors:

…

(b) biodiversity, with particular attention to species and habitats protected under [Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), as amended by Council Directive 2013/17/EU of 13 May 2013 (OJ 2013 L 158, p. 193) (“Directive 92/43”)] and Directive 2009/147/EC [of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ 2010 L 20, p. 7)];

…’

Article 4 of Directive 2011/92 provides:

‘1. Subject to Article 2(4), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10.

(a) a case-by-case examination;

(b) thresholds or criteria set by the Member State.

Member States may decide to apply both procedures referred to in points (a) and (b).

Where a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. Member States may set thresholds or criteria to determine when projects need not undergo either the determination under paragraphs 4 and 5 or an environmental impact assessment, and/or thresholds or criteria to determine when projects shall in any case be made subject to an environmental impact assessment without undergoing a determination set out under paragraphs 4 and 5.

Where Member States decide to require a determination for projects listed in Annex II, the developer shall provide information on the characteristics of the project and its likely significant effects on the environment. The detailed list of information to be provided is specified in Annex IIA. The developer shall take into account, where relevant, the available results of other relevant assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The developer may also provide a description of any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

The competent authority shall make its determination, on the basis of the information provided by the developer in accordance with paragraph 4 taking into account, where relevant, the results of preliminary verifications or assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The determination shall made available to the public and:

(a) where it is decided that an environmental impact assessment is required, state the main reasons for requiring such assessment with reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not required, state the main reasons for not requiring such assessment with reference to the relevant criteria listed in Annex III, and, where proposed by the developer, state any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

Member States shall ensure that the competent authority makes its determination as soon as possible and within a period of time not exceeding 90 days from the date on which the developer has submitted all the information required pursuant to paragraph 4. In exceptional cases, for instance relating to the nature, complexity, location or size of the project, the competent authority may extend that deadline to make its determination; in that event, the competent authority shall inform the developer in writing of the reasons justifying the extension and of the date when its determination is expected.’

Annex II.A of that directive contains the list of ‘information to be provided by the developer on the projects listed in Annex II’. That list reads as follows:

‘1. A description of the project, including in particular:

(a) a description of the physical characteristics of the whole project and, where relevant, of demolition works;

(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas likely to be affected.

(a) the expected residues and emissions and the production of waste, where relevant;

(b) the use of natural resources, in particular soil, land, water and biodiversity.

Annex III to that directive sets out the ‘criteria to determine whether the projects listed in Annex II should be subject to an environmental impact assessment’.

Directive 2014/52

Recitals 11 and 29 of Directive 2014/52 state:

‘(11) The measures taken to avoid, prevent, reduce and, if possible, offset significant adverse effects on the environment, in particular on species and habitats protected under [Directive 92/43] and Directive 2009/147 …, should contribute to avoiding any deterioration in the quality of the environment and any net loss of biodiversity, in accordance with the [European] Union’s commitments in the context of the [United Nations Convention on Biological Diversity, signed in Rio de Janeiro on 5 June 1992,] and the objectives and actions of the Union Biodiversity Strategy up to 2020 laid down in the [Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions] of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ [(COM(2011) 244 final)]

…

(29) When determining whether significant effects on the environment are likely to be caused by a project, the competent authorities should identify the most relevant criteria to be considered and should take into account information that could be available following other assessments required by Union legislation in order to apply the screening procedure effectively and transparently. In this regard, it is appropriate to specify the content of the screening determination, in particular where no environmental impact assessment is required. Moreover, taking into account unsolicited comments that might have been received from other sources, such as members of the public or public authorities, even though no formal consultation is required at the screening stage, constitutes good administrative practice.’

Directive 92/43

Article 6(3) of Directive 92/43 provides:

‘Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site’s conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public.’

Article 12(1) of that directive provides:

‘Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

(a) all forms of deliberate capture or killing of specimens of these species in the wild;

(b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

(c) deliberate destruction or taking of eggs from the wild;

(d) deterioration or destruction of breeding sites or resting places.’

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

Irish law

On 27 January 2003, the EMEA sent to Pfizer ApS, a member of the Pfizer group, a letter informing it of the referral and requesting the members of the Pfizer group that were holders of Lopid MAs (hereinafter ‘the Pfizer Companies’) to provide information and to pay the fee of EUR 10 000 provided for under Regulation No 297/95, as amended. The EMEA stated in the letter that the consultative opinion of the CPMP would be sent to the Commission, which was responsible for adopting the final decision following consultation with the Member States under Article 33 of the MPHU Code. That decision would apply to all holders of Lopid MAs, independently of whether those holders had provided answers to questions raised by the CPMP during the consultation procedure.

Procedure and forms of order sought

By application lodged at the Court Registry on 10 April 2003, the applicant brought the present action.

By a separate document lodged at the Court Registry on 25 May 2003, the Commission raised a preliminary objection as to admissibility under Article 114(1) of the Rules of Procedure of the Court of First Instance. On the same day, it applied for the present case to be joined with Cases T‑19/02 and T‑41/03. The applicant lodged its observations on that preliminary objection and on the application for joinder on 14 July 2003. After hearing the parties in Cases T-19/02 and T-41/03, the Court dismissed the application for joinder.

The Court put a question to the parties under the measures of organisation of procedure laid down in Article 64 of the Rules of Procedure. The parties responded in writing within the time allowed.

The applicant claims that the Court should:

–annul the contested decision;

–order the Commission to pay the costs.

In its preliminary objection as to admissibility, the Commission claims that the Court should:

–dismiss the application as inadmissible;

–alternatively, decline to rule on the application until an action to annul a definitive act of the Commission has been commenced;

–order the applicant to pay the costs.

In its observations on the preliminary objection as to admissibility, the applicant claims that the Court should:

–declare the application admissible;

–order the Commission to pay the costs.

Law

Pursuant to Article 114(1) of the Rules of Procedure, the Court may, if a party so requests, rule on the question of admissibility without considering the merits of the case. Under Article 114(3), unless the Court otherwise decides, the remainder of the proceedings is to be oral. In the present case, the Court considers that the information in the documents before it is sufficient for there to be no need to proceed to the oral stage of the proceedings.

It is settled case-law that only measures which produce binding legal effects capable of affecting an applicant’s interests by bringing about a significant change in his legal position are acts or decisions against which an action for annulment may be brought under Article 230 EC. To ascertain whether an act or decision has effects of that kind, it is necessary to examine its substance (Case 60/81 IBM v Commission [1981] ECR 2639, paragraph 9; Case C-308/95 Netherlands v Commission [1999] ECR I-6513, paragraph 26; Case T-562/93 Obst v Commission [1995] ECR-SC I‑A-247 and II‑737, paragraph 23; Case T‑81/87 Regione Toscana v Commission [1998] ECR II‑2889, paragraph 21; and Case T‑160/98 Van Parys and Pacific Fruit Company v Commission [2002] ECR II‑233, paragraph 60).

Furthermore, it is also settled case-law that, in the case of acts or decisions adopted by a procedure involving several stages, and particularly where they are the culmination of an internal procedure, it is in principle only those measures which definitively determine the position of the institution upon the conclusion of that procedure which are open to challenge, and not intermediate measures whose purpose is to prepare for the final decision (IBM v Commission, paragraph 10; Case C-147/96 Netherlands v Commission [2000] ECR I-4723, paragraph 26; Case T-326/99 Olivieri v Commission and EMEA, judgment of 18 December 2003, not yet published in the ECR, paragraphs 51 to 53).

It would be otherwise only if the acts or decisions adopted in the course of the preparatory proceedings not only bore all the legal characteristics referred to above, but in addition were themselves the culmination of a special procedure distinct from that intended to permit the institution to take a decision on the substance of the case (Joined Cases 8/66 to 11/66 Cimenteries CBR and Others v Commission [1967] ECR 75, 92, and IBM v Commission, paragraph 11).

Lastly, whilst measures of a purely preparatory nature may not themselves be the subject of an application for annulment, any legal defects therein may be relied upon in an action directed against the definitive act for which they represent a preparatory step (IBM v Commission, paragraph 12; Case 346/87 Bossi v Commission [1989] ECR 303, 333; Case T-108/92 Caló v Commission [1994] ECR-SC I‑A‑59 and II‑213, paragraph 13).

By the contested measure in the present case, the Commission initiated a referral to the CPMP under Article 30 of the MPHU Code for the application of the procedure under Article 32 of the Code in respect of various medicinal products for which the Pfizer Companies are the holders of MAs. By letter of 27 January 2003, the EMEA informed the Pfizer Companies of that referral and asked them, for the purposes of the procedure, to provide information and to pay the fee provided for under Regulation No 297/95, as amended.

The Court finds that the contested measure does not definitively determine the position of the Commission on the question of the harmonisation of the Lopid SPCs, any more than it represents the culmination of a special procedure distinct from that intended to result in a decision on that harmonisation. The measure does no more than set in motion the consultative procedure described in paragraphs 3 and 4 above, and merely represents a preliminary stage in that procedure.

The contested measure thus does not affect the legal position of the Pfizer Companies and is accordingly not a measure which is open to challenge under the case-law cited above. That conclusion is not affected by the applicant’s claims that the contested measure requires the Pfizer Companies to pay a fee of EUR 10 000 and to provide information to the EMEA, places them in a position of uncertainty similar to that arising in cases of State aid when proceedings are initiated under Article 88(2) EC, and involves a transfer of powers in relation to Lopid from the Member States to the Commission.

As regards, first, the obligation to pay a fee of EUR 10 000 as a contribution to the funding of the EMEA, it should be noted that the present application does not call into question the validity of the first indent of Article 4 of Regulation No 297/95, as amended, inasmuch as it requires payment of a fee to the EMEA when the procedure under Article 30 of the MPHU Code is initiated.

Nevertheless, the applicant claims that the obligation to pay a fee requires that the procedure be valid, a condition which is not met in the present case. It is clear in that regard that as the consultative procedure represents only an intermediate stage which is intended to result in the adoption of a final decision, its validity may be considered at the time of any challenge directed at the final decision. The applicant argues that there may never be a final decision; in that event, should the Pfizer Companies consider that they had suffered a loss by reason of an act for which the Commission was liable non-contractually, they could bring proceedings to recover that loss.

With respect, secondly, to the alleged obligation, on whose existence the applicant relies, to provide information to the EMEA as part of the consultative procedure, it is clear that that is an inevitable result of the consultative procedure and is necessary for its efficient conduct. It does not bring about a distinct change in the legal position of the Pfizer Companies.

Thirdly, contrary to what the applicant claims, the situation of the Pfizer Companies cannot be compared to that of undertakings faced with the initiation of proceedings under Article 88(2) EC. While the initiation of the formal examination procedure in State aid cases may entail independent legal effects in certain circumstances (Case C-312/90 Spain v Commission [1992] ECR I‑4117, paragraphs 17 to 20; Case C-47/91 Italy v Commission [1992] ECR I‑4145, paragraphs 25 to 30; Joined Cases T-269/99, T-271/99 and T-272/99 Diputación Foral de Guipúzcoa and Others v Commission [2002] ECR II‑4217, paragraph 37), the initiation of a referral to the CPMP under Article 30 of the MPHU Code has no legal effect on the MAs concerned, which may be freely exploited pending the adoption of any decision that may ensue.

Fourthly, with respect to the applicant’s claim that the initiation of a referral to the CPMP under Article 30 of the MPHU Code would have irreversible legal consequences given that, according to the Commission, it is tantamount to the harmonisation of the MAs in question and that there will be a transfer of powers from the Member States to the Community once that harmonisation is complete, it is clear that the initiation of a referral to the CPMP under Article 30 of the MPHU Code merely sets a consultative procedure in motion and does not in itself entail any harmonisation of the Lopid SPCs.

Lastly, the applicant is wrong to claim that if this action were to be dismissed as inadmissible, the Pfizer Companies would be deprived of judicial protection. As was pointed out at paragraph 29 above, it will be open to them to contest the validity of the consultative procedure should they bring proceedings against a final decision which is contrary to their interests and is based on the opinion of the CPMP and, if appropriate, to bring proceedings to recover any loss they may suffer.

In light of all the foregoing considerations, the application must be dismissed as inadmissible, and it is not necessary to consider the Commission’s alternative claim.

Costs

Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the defendant has applied for costs and the applicant has been unsuccessful, the latter must be ordered to pay the costs.

On those grounds,

hereby orders:

2.The applicant shall pay the costs.

Luxembourg, 2 June 2004.

Registrar

President

1Language of the case: English.

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