C-329/99

ORDER OF 18. 11. 1999 — CASE C-329/99 P(R)

ORDER OF THE PRESIDENT OF THE COURT 18 November 1999 *

In Case C-329/99 P(R),

Pfizer Animal Health SA, established at Louvain-la-Neuve, Belgium, represented by I.S. Forrester QC and E. Wright, Barrister, instructed by SJ. Gale-Batten, Solicitor, with an address for service in Luxembourg at the Chambers of A. May, 31 Grand-Rue,

appellant,

APPEAL against the order of the President of the Court of First Instance of the European Communities of 30 June 1999 in Case T-13/99 R Pfizer Animal Health v Council [1999] ECR 11-1961, seeking annulment of that order and referral of the case back to the President of the Court of First Instance for further consideration or grant of the application at first instance and an order that the Council pay the costs,

defendant at first instance,

Commission of the European Communities, represented by P. Oliver and T. Christoforou, Legal Advisers, and E Ruggeri Laderchi, of its Legal Service, acting as Agents, with an address for service in Luxembourg at the office of C. Gómez de la Cruz, also of its Legal Service, Wagner Centre, Kirchberg,

Kingdom of Denmark, represented by J. Molde, Head of Division, Ministry of Foreign Affairs, acting as Agent, with an address for service in Luxembourg at the Danish Embassy, 4 Boulevard Royal,

Republic of Finland, represented by H. Rotkirch, Ambassador, Director of the Legal Service, Ministry of Foreign Affairs, and T. Pynnä, Legal Adviser in the same Ministry, acting as Agents, with an address for service in Luxembourg at the Finnish Embassy, 2 Rue Heinrich Heine,

Kingdom of Sweden, represented by A. Kruse, Departementsråd in the Ministry of Foreign Affairs, acting as Agent, with an address for service in Luxembourg at the Swedish Embassy, 2 Rue Heinrich Heine,

Fédération Européenne de la Santé Animale (Fedesa) and Fédération Européenne des Fabricants d'Adjuvants pour la Nutrition Animale (Fefana), established in I - 8347

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THE PRESIDENT OF THE COURT

after hearing Advocate General Jacobs,

makes the following

Order

1 By application lodged at the Registry of the Court of Justice on 1 September 1999, Pfizer Animal Health SA appealed, pursuant to the second paragraph of Article 50 of the EC Statute of the Court of Justice, against the order of the President of the Court of First Instance of 30 June 1999 in Case T-13/99 R Pfizer Animal Health v Council [1999] ECR 11-1961, 'the contested order'); in that order the President of the Court of First Instance dismissed Pfizer's application for suspension of the operation of Council Regulation (EC) No 2821/98 of 17 December 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs (OJ 1998 L 351, p. 4, 'the contested regulation') or for the adoption of such other measures as justice might require.

5 The purpose of Directive 70/524 is to lay down a list of additives the incorporation of which in feedingstuffs is authorised at Community level for an indeterminate period, together with the conditions attaching to their incorpora- tion. It also sets out the circumstances in which and the procedure by which, for their part, Member States are entitled to adopt safeguard measures temporarily to suspend or restrict the use of an authorised additive on their territory and, for its part, the Commission may have amendments to the Directive adopted in order to ensure the protection of human or animal health or the environment.

Facts

6 The present state of knowledge of antibiotics and of the resistance which bacteria can develop from the use of antibiotics designed to combat them ('antibiotic I - 8350

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resistance'), as assessed by the President of the Court of First Instance, is set out in paragraphs 12 to 16 of the contested order.

7 In particular, according to paragraph 15 thereof, '[s]cientists are agreed that there exists a real danger that antibiotics may become ineffective both in the short term and in the long term, that fewer new remedies are being developed and that permanent resistance to various remedies is becoming entrenched'.

12 The Council's reasons for adopting the contested regulation, as they appear in its preamble, are set out in paragraphs 24 to 30 of the contested order. Essentially they express concern with regard to the emergence of antibiotic resistance referred to in paragraphs 6 and 7 of this order.

Procedure

13 By application lodged at the Registry of the Court of First Instance on 18 January 1999, Pfizer sought the annulment, in whole or in part, of the contested regulation.

14 By separate document lodged at the Registry of the Court of First Instance on 15 February 1999, Pfizer also applied, pursuant to Articles 185 and 186 of the EC Treaty (now Articles 242 EC and 243 EC), first, for suspension, either in whole or in part, of operation of the contested regulation pending judgment in the I - 8352

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main action or until a date to be fixed, and, second, for the adoption of such other measures as justice might require.

18 The President of the Court of First Instance went on to consider, at paragraphs 134 to 181 of the contested order, whether the application had the degree of urgency required before the measure requested could be ordered and whether the balancing of the interests at stake operated in the applicant's favour.

19 In that connection the President of the Court of First Instance held, at paragraph 136 of the contested order, that the only damage that could be taken into account in his examination of the criterion of urgency was that which might be caused to the interests of the party seeking the interim relief.

20 With regard to damage of a purely pecuniary nature, the President of the Court of First Instance examined, first, whether Pfizer's very existence was likely to be endangered, concentrating on the effects of application of the contested regulation on the Rixensart factory and on Pfizer's financial viability and, second, whether its market share was likely to be irremediably affected.

21 As far as the Rixensart factory was concerned, the President of the Court of First Instance found that it could not be concluded, on the evidence before him, that the entry into force of the contested regulation would inevitably result in the rapid closure of the plant in view of the high volume and value of sales of virginiamycin on markets other than the West European market.

22 In his view, it had not been shown that the reduction in employment envisaged by Pfizer, concerning 18% of the Rixensart staff, was likely to lead to the closure of I - 8354

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ORDER OF 18. 11. 1999 — CASE C-329/99 P(R)

health which would be liable to be caused by suspension of the contested regulation.

27 The President of the Court of First Instance found that the documents before him confirmed that bacteria resistant to virginiamycin in animals were transmissible to humans. It followed, in his view, that the risk of increased antimicrobial resistance in human medicine on account of the use of virginiamycin in animal feed could not be ruled out, and the potential consequences for public health would be very serious. In the circumstances, the President considered that, without prejudging the examination by the Court of First Instance of the assessment of the extent of the risk which must be established by the institutions concerned when adopting a precautionary measure, the mere existence of the risk so identified was enough in itself to justify taking into account, in the balancing of interests, the protection of human health.

Arguments of the parties

28 Three of the grounds of appeal, together with the additional plea put forward by H. Kerckhove and P. Lambert, concern the assessment by the President of the Court of First Instance of the urgency of the matter. The last ground of appeal concerns the balancing of interests undertaken in the contested order.

Wrongful determination of harm because the situation of Pfizer's parent company was taken into account

32 The Council, the Commission and the Finnish Government also contend that the case-law cited in paragraph 155 of the contested order is entirely relevant and confirm that it was wholly justifiable to take into account the situation of the appellant's parent company. The Commission considers the complaint that that criterion would lead to discrimination against large groups to be wholly misconceived. In its view, when it comes to deciding whether a measure will have serious and irreparable financial consequences for an applicant, it is obviously necessary to have regard to the latter's financial situation, which clearly cannot be assessed without taking account of the financial situation of the group to which it belongs. For its part the Council, emphasising the appellant's links with its parent

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company, states that it has at its disposal the vast resources of a multinational company to assist it in coping with the withdrawal of a single product.

Wrongful determination of damage with regard to the case-law of the Court of Justice on irretrievable loss of market share

33 The second ground of appeal alleges an infringement of Community law by reason of the fact that the President of the Court of First Instance wrongly concluded that there would be no irretrievable loss of market share. Such loss was not acknowledged in this case, in which the product concerned is wholly banned in the 15 Member States, whereas a much lower level of loss in a few Member States has previously been regarded as irreparable damage.

37 According to the Council, the Commission and the Danish Government, the findings of the President of the Court of First Instance that the market share concerned could be recovered and that the appellant was financially able to bear the cost of keeping on those 31 employees of the Rixensart factory are findings of fact, so that the second ground of appeal is inadmissible.

38 Furthermore, the Council, the Commission and the Danish and Finnish Governments consider that the appellant's situation in this case is, in point of fact, quite distinct from that of the undertakings involved both in Bayer v Commission, cited above, in which it was held that there was a real risk that the business of a subsidiary could be irreversibly harmed in so far as 56% of the subsidiary's turnover was affected, and in Pfizer International v Commission, cited above, in which loss of market share was held to be irretrievable in view of the characteristics of the product concerned.

Wrongful determination of damage because the situation in third countries was not taken into account

39 In the third ground of appeal, the appellant challenges the refusal by the President of the Court of First Instance to take into consideration, when determining I - 8359

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damage, the effects of the ban on virginiamycin in the European Community on its sales in third countries which, de jure or de facto, apply Community legislation, on the ground that such damage is not a direct consequence of the contested regulation.

the case as regards the 16 other countries cited. In any event, the Council, together with the Danish Government, points out that the appellant has failed to indicate the actual loss of market share which it would sustain in those 21 countries, in terms of volume or percentages of sales, following the ban on sale in the European Community. As far as the other third countries are concerned, the Council endorses the assessments set out in paragraph 160 of the contested order.

Failure to take into account the damage sustained by the interveners

45 H. Kerckhove and P. Lambert further maintain that the President of the Court of First Instance was wrong in refusing to take into account, in his assessment of urgency, the damage caused to the interveners and in postponing consideration of that damage until the stage of balancing the interests at stake. Third parties who do not themselves have an admissible case but who are given leave to intervene in proceedings for interim relief on the ground that their interests could be affected by the result of the case ought to have their interests protected, which is impossible if the damage they allege may be ignored when the urgency of the application is assessed. In the absence of such protection, those third parties might be prompted to turn to a national court in order to obtain interim protection of their interests, which would undermine the uniform application of Community law.

Over-restrictive application of the criteria for granting an interim measure, leading to a failure to weigh up the interests at stake

49 According to the appellant, just as the Council should have weighed up the purely theoretical risk that virginiamycin might one day cause damage in terms of public health against the harm that a ban would cause, the President of the Court of First Instance should have undertaken a genuine balancing of the interests at stake.

50 The appellant adds that in this case the situation, in terms of public health, is substantially less serious than that which prevailed at the time of the embargo on British beef, so that the principles applied then in Cases C-157/96 National I - 8362

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Farmers' Union and Others [1998] ECR1-2211 and C-180/96 United Kingdom v Commission [1998] ECR I-2265 could not simply be transposed here.

51 The appellant claims that the Community institutions' assertion that a risk may exist is necessary, but not sufficient, to justify a ban. Similarly, when examining an application for interim measures, the Court should not just consider the allegation of a risk but must examine its gravity and the proximity of possible harm. According to the appellant, in refusing to balance the interests at stake the President of the Court of First Instance thus committed an error of law.

54 H. Kerckhove and P. Lambert also maintain that a sales ban motivated by the protection of health and consumer safety is justified only if the existence of a risk has been established. It is clear from paragraphs 180 and 181 of the contested order that the President of the Court of First Instance identified only a potential risk that might one day develop into an actual risk. In their view, as long as a potential risk has not developed into an actual risk, precautionary measures are generally premature unless a thorough balancing of interests clearly favours the adoption of such measures. Where Community measures are taken otherwise than in order to protect against an immediate danger to public health, it cannot, contrary to what is stated in paragraphs 170 and 171 of the contested order, be presumed that public health must take precedence without a detailed weighing up of all the interests involved, including those of the interveners.

55 The Council and the Finnish Government consider that the appellant is not entitled to challenge the findings of fact made by the President of the Court of First Instance. Those findings are based on a World Health Organisation Report and evidence put forward by Pfizer itself, as is clear from paragraphs 179 and 180 of the contested order, and the President concluded that the existence of a risk to human health could not be ruled out. The Council also considers that there is no legal obligation to examine the gravity of such a risk once the existence of a risk has been established.

56 For its part, the Commission claims that the whole of the appellant's plea relating to the balancing of interests is based on the flawed premiss that the risk posed by virginiamycin was merely theoretical. The Commission cites the studies carried I - 8364

60 First of all, under Article 225 EC and Article 51 of the EC Statute of the Court of Justice, an appeal is to be limited to points of law and must lie on the grounds of lack of competence of the Court of First Instance, a breach of procedure before it which adversely affects the interests of the appellant or the infringement of Community law by the Court of First Instance.

61 The Court of First Instance has exclusive jurisdiction to establish the facts, save where a substantive inaccuracy in its findings is apparent from the documents submitted to it, and to appraise those facts. I - 8365

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62 Furthermore, the Court of Justice does not in principle have jurisdiction to examine evidence which the Court of First Instance has accepted in support of its findings of fact or assessment of the facts. Where the general principles of law and rules of procedure governing the burden of proof and the taking of evidence have been observed, it is for the Court of First Instance alone to assess the weight to be attributed to the evidence produced (Case C-159/98 P(R) Netherlands Antilles v Council [1998] ECR 1-4147, paragraph 68).

63 It is in the light of those factors that the grounds of appeal must be examined.

First ground

69 The appellant is therefore mistaken in its claim that the President of the Court of First Instance took into account the characteristics of the group to which it belongs when assessing the effects which the contested regulation might have on the Rixensart factory.

70 As for the interests of the Rixensart factory employees, the President of the Court of First Instance pointed out, in paragraph 149 of the contested order, that it hardly seemed likely that the appellant would be unable to bear the financial burden which would be involved in keeping 31 persons in employment pending judgment in the main action.

71 That assessment by the President of the Court of First Instance, which implies that an adverse effect on the interests of employees is not an inevitable consequence of the operation of the contested regulation, is not open to challenge in an appeal.

72 The first ground of appeal must therefore be dismissed. I - 8367

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Second ground

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78 The second ground of appeal must therefore be dismissed.

Third ground

79 In its third ground of appeal, the appellant complains that the President of the Court of First Instance did not take into consideration, in determining damage, the impact of the contested regulation on sales of virginiamycin in third countries.

80 That plea is based, first of all, on the content of the agreements linking the European Community with third country applicants for accession, on the one hand, and with the CIS countries on the other, which are said to impose a legal obligation on those two categories of country to adopt a ban analogous to that provided for in the contested regulation.

81 It must be remembered that, under Article 113(2) of the Rules of Procedure of the Court of Justice, the subject-matter of the proceedings before the Court of First Instance may not be changed in the appeal.

86 In a supplementary plea, H. Kerckhove and P. Lambert maintain that the damage sustained by them should have been taken into consideration by the President of the Court of First Instance when he assessed the question of urgency.

87 In support of this plea, those interveners contend that since they have been recognised as having a sufficient interest to intervene, that interest can only be protected if, for the purpose of assessing the question of urgency, the damage they claim they will sustain is taken into consideration. Furthermore, the contrary practice followed by the President of the Court of First Instance is likely to jeopardise the uniform interpretation of Community law, by encouraging interested third parties to turn to their national courts in order to obtain interim protection of their interests. I - 8370

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88 The first point to note is that it follows from the first subparagraph of Article 83(1) of the Rules of Procedure of the Court of Justice that only the person who has challenged a measure of an institution in proceedings before the Court has standing to apply for suspension of operation of that measure.

89 Furthermore, in order for that application for suspension of operation to be held admissible, the applicant must establish that there are grounds for concluding prima facie that the main application to which the application for interim measures relates is admissible, in order to prevent a situation where that person is able, by means of an application for interim measures, to obtain suspension of the operation of a measure which the Court subsequently refuses to declare void because, on examination of the substance of the case, the application is declared inadmissible (see Case 376/87 R Distrivet v Council [1988] ECR 209, paragraphs 21 and 22).

94 The urgency of an application for the adoption of interim measures must therefore be assessed in the light of the extent to which an interlocutory order is necessary in order to avoid serious and irreparable damage to the party seeking the adoption of the interim measure, as has moreover repeatedly been confirmed by the Court (see, in particular, Case 310/85 R Deufil v Commission [1986] ECR 537, paragraph 15).

95 That conclusion cannot be undermined by the considerations of expediency formulated by H. Kerckhove and P. Lambert on the basis of the objective of the uniform interpretation of Community law.

96 It is, moreover, quite clear that the President of the Court of First Instance took into consideration the interest of the interveners when balancing the interests at stake, so that their intervention was not rendered futile.

97 It follows from the foregoing that the plea raised by H. Kerckhove and P. Lambert must be dismissed.

Fifth ground of appeal

98 In its final ground of appeal, the appellant complains that the President of the Court of First Instance applied over-restrictive criteria for the grant of an interim I - 8372

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which would be liable to be caused by suspension of the contested regulation, and which could not be remedied if the main action were subsequently dismissed'.

103 The ground of appeal concerning the balancing of interests must therefore be rejected as well.

104 In the light of all the above considerations, the appeal must be dismissed.

Costs

105 According to Article 69(2) of the Rules of Procedure, applicable to the appeal procedure by virtue of Article 118 thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. Article 69(4) provides that the Member States and institutions which intervene in proceedings are to bear their own costs and that the Court may order other interveners to do the same. Since the appellant's pleas have been unsuccessful, and the Council has applied for costs, the appellant must be ordered to pay the costs of this appeal. The Commission, the Kingdom of Denmark, the Republic of Finland, the Kingdom of Sweden, Fedesa and Fefana and H. Kerckhove and P. Lambert must bear their own costs. I - 8374

3. The Commission of the European Communities, the Kingdom of Denmark, the Republic of Finland, the Kingdom of Sweden, Fédération Européenne de la Santé Animale and Fédération Européenne des Fabricants d'Adjuvants pour la Nutrition Animale, Hedwig Kerckhove and Paul Lambert are ordered to bear their own costs.

Luxembourg, 18 November 1999.

R. Grass G.C. Rodríguez Iglesias Registrar President

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