T-70/99

ORDER OF 30. 6. 1999 — CASE T-70/99 R

ORDER OF THE PRESIDENT OF THE COURT OF FIRST INSTANCE 30 June 1999 *

In Case T-70/99 R,

Alpharma Inc., a company constituted in accordance with the law of the United States of America, established in Fort Lee, United States, represented by Gavin Robert, Solicitor, and Bernard van de Walle de Ghelcke, of the Brussels Bar, with an address for service in Luxembourg at the Chambers of Freddy Brausch, 11 Rue Goethe,

applicant,

v

Commission of the European Communities, represented by Peter Oliver and Theofanis Christoforou, Legal Advisers, and Francesco Ruggeri Laderchi, of its Legal Service, acting as Agents, with an address for service in Luxembourg at the office of Carlos Gómez de la Cruz, of its Legal Service, Wagner Centre, Kirchberg,

Republic of Finland, represented by Holger Rotkirch, Director of the Legal Service in the Ministry of Foreign Affairs, and Tuula 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,

and

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

interveners,

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) or for other interim measures, II - 2031

2 Article 2 of the initial version of Directive 70/524 defined additives as 'substances which, when incorporated in feedingstuffs, are likely to affect their characteristics or livestock production'. II - 2032

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3 Article 7(1) of Directive 70/524, in the version resulting from Council Directive 84/587/EEC of 29 November 1984 amending Directive 70/524 (OJ 1984 L 319, p. 13, hereinafter 'Directive 84/587'), a provision which has subsequently been amended, states:

'Amendments to be made to annexes on account of the growth of scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 23.'

4 The regime established by Directive 70/524 was substantially modified by Council Directive 96/51/EC of 23 July 1996 amending Directive 70/524 (OJ 1996 L 235, p. 39, hereinafter 'Directive 96/51'). Article 2 of Directive 96/51 provides that the Member States are to bring into force the laws, regulations and administrative provisions necessary to comply with Article 1(4) thereof, in so far as it enacts new Articles 6(1), 9d(2), 9e(3), 9f, 9g, 9h, 9i, 9j, 9n and 9o of Directive 70/524, and Article 1(10), (12), (19) and (20) thereof on 1 April 1998 and with its other provisions on 1 October 1999.

5 In particular, Article l(3)(i) of Directive 96/51 provides for the replacement of Article 2(a) of Directive 70/524 by the following wording:

(aa) "micro-organisms": micro-organisms forming colonies;

(aaa) additives subject to authorisation linked to the person responsible for putting them into circulation: the additives listed in Part I of Annex C; II - 2034

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(aaaa) other additives: additives not subject to authorisation linked to the person responsible for putting them into circulation and referred to in Part II of Annex C'.

6 Article 9g of Directive 70/524, as inserted by Article 1(4) of Directive 96/51, provides:

'1. Additives as referred to in Article 2(aaa) [additives subject to authorisation linked to the person responsible for putting them into circulation: the additives listed in Part I of Annex C] included in Annex I before 1 January 1988 shall be provisionally authorised as from 1 April 1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them into circulation.

'1. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that the use of one of the additives authorised or its use in conditions which may be specified constitutes a danger to animal or human health or the environment although it complies with the provisions of this directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision.

2. The Commission shall, as soon as possible, examine the grounds cited by the Member State concerned and consult the Member States within the Standing Committee for Feedingstuffs; it shall then deliver its opinion without delay and take the appropriate measures.

3. Should the Commission consider that amendments to the directive are necessary in order to mitigate the difficulties mentioned in paragraph 1 and to ensure the protection of human or animal health or the environment, it shall initiate the procedure laid down in Article 24 with a view to adopting those amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force.'

8 Article 23 of Directive 70/524, as inserted by Article 1(1) of Directive 84/587 and last amended by Annex I to the Act concerning the conditions of accession of the II - 2036

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Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded (OJ 1994 C 241, p. 21, hereinafter 'the Act of Accession'), provides:

9 Article 24 of Directive 70/524, as inserted by Article 1(1) of Directive 84/587 and last amended by Annex I to the Act of Accession, provides:

' 1 . Where the procedure laid down in this article is to be followed, matters shall be referred to the [Standing] Committee [for Feedingstuffs] without delay by the chairman, either on his own initiative or at the request of a Member State.

2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion within two days. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that article. The chairman shall not vote.

3. The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.

If the Council has not adopted any measures within 15 days of the proposal being submitted to it, the Commission shall adopt the proposed measures and II - 2038

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12 The Annex to Decision 97/579 defines the competence of the SCAN as covering 'scientific and technical questions concerning animal nutrition, its effect on animal health, on the quality and health of products of animal origin, and concerning the technologies applied to animal nutrition'.

13 In addition, Article 8(1) of Directive 70/524, as amended by Directive 96/51, provides:

'The Scientific Committee for Animal Nutrition established by Commission Decision 76/791/EEC [of 24 September 1976] shall be responsible for assisting the Commission, at the latter's request, on all scientific questions relating to the use of additives in animal nutrition.'

Facts

1 4 Defined in general terms, an antibiotic is a substance of biological or synthetic origin, specifically acting at an essential stage of the metabolism of bacteria (antibacterial agents) or fungi (antifungal agents).

15 Antibiotics are used, both in humans and in animals, to treat various bacterial diseases. In animals, antibiotics may be used for therapeutic or prophylactic purposes or as growth promoters.

20 When administered on a regular basis to livestock, bacitracin zinc promotes growth, in particular by enhancing the functioning of the animal's intestinal flora and reducing the incidence of digestive problems. II - 2041

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21 Bacitracin zinc was authorised as an additive in feedingstuffs under the procedure initially laid down by Directive 70/524 and was thus listed in Annex I. Since a new use for bacitracin zinc was provisionally authorised by Commission Directive 94/41/EC of 18 July 1994 amending Directive 70/524 (OJ 1994 L 209, p. 18), it was also listed in Annex II to Directive 70/524. That authorisation covering chickens for fattening and pigs was extended to 17 July 1999 by Commission Regulation (EC) No 2786/98 of 22 December 1998 concerning the modification of the period of authorisations of additives referred to in Article 9i(l) of Council Directive 70/524 (OJ 1998 L 347, p. 25, hereinafter 'Regulation No 2786/98').

22 In addition, bacitracin zinc has, since 1 April 1998, been subject to a re- evaluation procedure pursuant to Directive 96/51.

The entries in Annex B to Directive 70/524/EEC for the following antibiotics shall be deleted:

— bacitracin zinc,

Article 2

The Commission shall re-examine the provisions of this regulation before 31 December 2000 on the basis of the results given by

— the different investigations concerning the induction of resistances by the use of the antibiotics concerned, II - 2043

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26 In recital 22 in the preamble to the contested regulation the Council states:

'Whereas bacitracin zinc, a cyclic polypeptide, is also used in human medicine mainly for topical treatment of infections of the skin and mucosal surfaces; whereas publications show that it could possibly be used for the treatment of II - 2044

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vancomycin-resistant enterococci, which represent a clinical problem in human medicine; whereas selected resistances from the use of bacitracin zinc as a feed additive inevitably increase the reservoir of resistances to bacitracin zinc; whereas the percentage of Enterococcus faecium resistant to bacitracin zinc is higher in chickens which have received bacitracin zinc than in chickens which have not received it; whereas these resistances could be transferred from animals to humans and reduce the effectiveness of bacitracin zinc used as a human medicinal product; whereas the effectiveness of bacitracin zinc in human medicine should therefore be preserved.'

27 Recitals 23 to 27 in the preamble state:

'(23) Whereas according to the conclusions of the World Health Organisation conference held in Berlin in October 1997, the Economic and Social Committee of the European Union, the International Office of Epizootics and the conference on antibiotic resistance held in Copenhagen in September 1998, antibiotic resistance must henceforth be regarded as a major, complex problem of international dimensions; whereas, in the sense of the recommendations arising from these conferences, it is desirable to set up a system of general surveillance of antimicrobial resistance resulting from the use of antibiotics; whereas, further- more, the phenomena of resistance encountered not only in hospitals but also in the general population should be addressed;

28 The programme of surveillance of microbial resistance in animals which have received antibiotics, referred to in Article 2 of the contested regulation and introduced following the adoption of Commission Directive 97/6/EC of 30 January 1997 amending Directive 70/524 (OJ 1997 L 35, p. 11), has been conducted under the auspices of the Commission since April 1998. That programme, involving the industry concerned, the Commission and six Member States, is being carried out by the persons responsible for putting the additives concerned into circulation. Its aim is to gauge, over a period of two years, the prevalence of resistance in animal enterococci, or the degree of sensitivity of those enterococci, to seven antibiotics used in locations with different practices as regards the use of feedingstuffs.

29 In addition, the Scientific Steering Committee within the Commission's Direc- torate-General for Consumer Policy and Consumer Health Protection (DG XXIV) established a Multidisciplinary Scientific Steering Committee on Anti- biotic Resistance in March 1998. The remit of that steering committee is to II - 2046

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conduct a broad review of the literature and output of other institutions relating to the use of antibiotics and the development of resistance in the areas of human pharmaceuticals, veterinary pharmaceuticals and feed additives.

30 Lastly, recital 23 in the preamble to the contested regulation refers to the World Health Organisation (WHO) conference held in Berlin in October 1997 on 'The Medical Impact of the Use of Antimicrobials in Food Animals'. In the report of that conference, the WHO recommended that the use of any antimicrobial agent for growth promotion in animals should be terminated if it is used in human therapeutics.

35 By application lodged at the Registry of the Court of First Instance on 30 March 1999, the Commission applied for leave to intervene in support of the form of order sought by the defendant in the proceedings for interim relief.

36 By letter of 8 April 1999, the Kingdom of Sweden applied for leave to intervene in support of the form of order sought by the defendant in the proceedings for interim relief.

37 Those applications for leave to intervene were served, in accordance with Article 116(1) of the Rules of Procedure, on the applicant and the defendant, which submitted their observations within the time-limits prescribed.

38 By order of 14 April 1999 the President of the Court of First Instance allowed the intervention of the Republic of Finland, the Kingdom of Sweden and the Commission in Case T-70/99 R and granted, at the stage of the proceedings for interim relief, the applicant's request for confidential treatment vis-à-vis the parties granted leave to intervene.

39 Each of the parties granted leave to intervene lodged its observations within the period prescribed.

40 The parties presented oral argument at the hearing on 26 April 1999. II - 2048

43 Whilst the Council does not formally plead the inadmissibility of the application for interim measures, it nevertheless asserts, supported by the Commission, that the claim in the main proceedings is inadmissible. It considers, in essence, that the contested regulation is not of individual concern to the applicant within the II - 2049

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meaning of the fourth paragraph of Article 173 of the Treaty. The Commission points out in this regard that an unlimited number of persons may currently produce and market bacitracin zinc, that other undertakings are currently producing and lawfully marketing it, and that there is nothing to prevent the other producers from applying for and receiving a new authorisation linked to the person responsible for putting the additive into circulation, in accordance with Directive 70/524, as amended by Directive 96/51.

44 The applicant asserts, by contrast, that its main action is admissible because it was the only undertaking to submit before 1 October 1998, in accordance with Article 9g(2) of Directive 70/524, an application for authorisation linked to the person responsible for putting the additives into circulation, with a view to re- evaluation of the additives referred to in Chapter I of Annex B to that directive. Therefore, it is currently the only company which can be affected by the prohibition on bacitracin zinc after 1 October 1999, the date on which the new system established by Directive 96/61 enters into force. Moreover, it is apparent from Chapter I of Annex B to Directive 70/524, as amended by Directive 96/51, that authorisation will be linked to the person responsible from 1 October 1999, so that generic copies will be prohibited as from that date.

48 The choice of legal basis dictates the choice of procedure for withdrawing authorisation of an additive. In so far as the contested regulation bans spiramycin, virginiamycin and tylosin phosphate, it is based on Article 11(3) of Directive 70/524, a provision which refers to the emergency procedure set out in Article 24 of that directive. However, that emergency procedure contrasts with the normal procedure for withdrawing authorisation of an additive governed by Article 23 of Directive 70/524, under both the former version of Article 7 and Article 9m as inserted by Directive 96/51. The applicant accordingly maintains that, by failing to adhere to the periods laid down by Article 23 of Directive 70/524, the institutions have denied it the benefit of those periods. Furthermore, the speed with which the procedure was carried out deprived the Standing Committee for Feedingstuffs and the Council of the opportunity to consider fully all the scientific evidence in relation to bacitracin zinc.

49 Second, the Council manifestly erred in its assessment. According to the second indent of the first paragraph of Article 9m of Directive 70/524, as inserted by Directive 96/51, a regulation withdrawing authorisation in respect of an additive may be adopted if one of the conditions for its authorisation referred to in Article 3a of Directive 70/524 is no longer met. Under Article 3a(e), Community authorisation of an additive is to be granted only if 'for serious reasons concerning human or animal health its use must not be restricted to medical or veterinary purposes'. It has not been established that there are serious reasons

52 Third, the Council infringed the principle of proportionality, the principle of the protection of legitimate expectations and its right to be heard. II - 2052

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53 The principle of proportionality was infringed because the ban on bacitracin zinc will result in the use of alternative antibiotics which are used in human medicine. Furthermore, rather than banning bacitracin zinc, the human use of that antibiotic could have been controlled.

54 The principle of the protection of legitimate expectations was also infringed, because the contested regulation was adopted when the surveillance programme concerning microbial resistance in animals which have received antibiotics was in the course of being implemented, the Multidisciplinary Scientific Committee on Antimicrobial Resistance had not yet completed its work and an immediate ban was not justified by any new information.

55 Finally, it maintains that, as the world's leading manufacturer of bacitracin zinc and its only producer for human use, it should have been given the opportunity to submit its observations on the proposed ban.

60 Thus, in accordance with the relevant provisions of the Act of Accession, the procedure to be followed for the withdrawal of authorisation in respect of bacitracin zinc was that set out in Article 23 of Directive 70/524, while the application of the safeguard provisions in Article 11 of that directive meant that the procedure under Article 24 thereof had to be followed for the withdrawal of authorisation in respect of the other antibiotics. Both of those provisions require the Commission to refer the matter to the Standing Committee for Feedingstuffs and the only differences between them are the periods within which that committee must deliver its opinion and the Council is required to act. II - 2054

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62 The Council goes on to state that it acted in a precautionary manner, since the contested regulation was adopted in order to prevent all actual and foreseeable risks to public health from the dual use of antibiotic substances. The political decision was made in the present case by striking a balance between, first, the maintenance, pending scientific studies, of the status quo with respect to a product used as a growth promoter in animal husbandry, primarily in order to enhance growth and reap quicker and better profits for the farming community, and secondly, the withdrawal of authorisation in respect of the four substances for mandatory reasons related to public health. In that context, it points out that growth promoters other than bacitracin zinc, which do not have dual use, are still authorised. Therefore, in deciding to withdraw authorisation in respect of bacitracin zinc, the Community chose in favour of protecting the overriding interest of public health, on the basis of the evidence before it and following an assessment of the possible dangers to public health.

63 The Council and the Commission note that, where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent (Case C-157/96 The Queen v MAFF and Another ex parte National Farmers' Union and Others [1998] ECR I-2211, paragraph 63, and Case T-199/96 Bergaderm and Goupil v Commission [1998] ECR II-2805, paragraph 66).

67 The Council also denies any breach of the principle of proportionality, as formulated in paragraph 96 of the judgment in Case C-180/96 United Kingdom v Commission [1998] ECR I-2265. In matters concerning the common agricultural policy, the Community legislature has a discretionary power, so that the legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate to the objective pursued (Case C-331/88 The Queen v MAFF and Another ex parte Fedesa and Others [1990] ECR I-4023, paragraphs II - 2056

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13 and 14). On the basis of the scientific evidence available, the Community institutions did not act in a manifestly inappropriate manner. Moreover, the Kingdom of Sweden submits, in the light of experience in that country following the banning of antibiotic growth promoters in 1986, that it is possible to raise animals without growth-promoting antibiotics whilst retaining proper health conditions.

68 The Council states that the institutions are all the more justified in adopting protective measures without having to wait until the reality and seriousness of the risks become fully apparent where a substance which could have adverse effects on human health is not indispensable for the well-being of animals and alternative products are available.

69 Nor can the applicant's argument set out in paragraph 53 above be accepted. The alleged increase in the use of alternative products for veterinary purposes would constitute a serious infringement of Article 3a(d) of Directive 70/524.

70 The Council considers, moreover, that the applicant's proposal concerning the imposition of stricter controls in connection with the use of the substance in human medicine entirely misses the point behind the Community action. In particular, the possibility of using bacitracin zinc for treating patients with vancomycin-resistant enterococci is increasingly becoming a reality, to the point that it could become a reserve antibiotic. The overriding principle of the WHO, adhered to by the Community, is that antibiotic substances used in human medicine should not be used as animal growth promoters. Although bacitracin is II - 2057

73 As regards the plea alleging infringement of Article 190 of the EC Treaty (now Article 253 EC), the Council points out that the contested regulation contains a preamble with 35 recitals and that recital 22 is specifically devoted to bacitracin zinc, its current and potential use in human medicine, the resistances already recorded in animals and the possibility that those resistances could be transferred from animals to humans. The Commission adds that Regulation No 2786/98 entered into force and was published before the contested regulation, which therefore amended the former by implication. II - 2058

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Urgency

74 The applicant claims that, if the operation of the contested regulation is not suspended, its animal health business within the European Union will soon be eliminated. Its turnover from the sale of animal health products in Europe amounts to EUR (...), 1 of which EUR (...) are attributable to sales of Albac.

75 The applicant submits that it will suffer serious and irreparable damage which is difficult to assess in financial terms by reason of: loss of turnover during the period leading up to the actual ban on bacitracin zinc; loss of earnings from 1 July 1999; permanent loss of its market share in the European Union; lasting prejudice to its reputation and product; long-term loss of know-how and experience; severance of the existing distribution network; damage to its market; increased costs at its factory in Oslo; and effects generated by the ban outside the Community.

76 In order to establish the imminence and the extent of the harm to which it is exposed, the applicant relies on a number of documents annexed to its application, namely a report drawn up by Alpharma's Director for Europe, the Middle East and Africa containing estimates of financial losses and loss of market share caused by the ban on the use of bacitracin zinc in the Community (hereinafter 'the Berntsen report'), a file containing correspondence from the applicant's distributors in Europe and a letter from the Director of Brakke Consulting Inc. Europe, a firm of consultants operating in the animal health sector (hereinafter 'the Brakke letter').

78 The applicant relies on the Berntsen report, which indicates the projected loss of earnings from the sale of bacitracin zinc for the period from 1999 to 2009. It states that its sales of bacitracin zinc would have almost doubled between 1999 and 2009 and that, in revenue terms, the loss of earnings is likely to be more than double at the end of that period. Those estimates are, moreover, conservative because, except for certain specific circumstances relating to Austria, Denmark and the Netherlands, the figures assume only an annual average growth in turnover of 8% and an annual price increase of 2%. However, over the last four years turnover from sales of Albac has increased by an average of (...)% annually, in both volume and value. Demand for Albac would also have been assisted in the future because, from 1 October 1999, sales of generic bacitracin zinc would no longer have been authorised within the European Union, as a result of the application of the rules.

— Permanent loss of market share in the Community

79 The Berntsen report, confirmed by the Brakke letter, gives an estimate of the current market share of bacitracin zinc produced by the applicant in the animal feed market in all the Member States and in the Community, and of the shares of other substances not produced by the applicant, namely: virginiamycin, avilamycin and flavomycin for the broiler and turkey segment; tylosin, virginiamycin, salinomycin, avilamycin and flavomycin for the swine segment; and virginiamycin and flavomycin for the calf segment. II - 2060

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case, to regain a level of knowledge and experience such as that of the experts it currently employs. That conviction is borne out by the case study on avoparein contained in the Berntsen report.

— Damage caused to distribution

83 The applicant states that the teams in the various Member States responsible for the distribution of bacitracin zinc, with which it has long-standing contractual ties, will be either dismantled or redeployed, with ensuing losses of know-how. Furthermore, the personal relationships built up between marketing specialists and customers, crucial for the commercial success of a product, will probably be lost because of the ban. In addition, each of the applicant's distributors will suffer, directly and indirectly, significant financial loss due to their inability to market Albac, as is clear from the file containing correspondence from the applicant's European distributors.

84 As the distribution contracts which it has entered into will have to be terminated because of the ban, each of the distributors will attempt to replace bacitracin zinc with relatively comparable products, such as probiotics, organic acids, acidifiers and immunostimulators. The applicant anticipates that those products will be distributed on an exclusive basis so that, as the Brakke letter points out, it is more than likely that the applicant's access to its current distribution chain will be precluded after a period of two years. Even if distributors can also market products competing with Albac, that is likely to reduce their interest and II - 2062

86 The applicant's plant and the Skøyen facility in Oslo (hereinafter 'the Oslo factory') currently produce (...) kg of bacitracin zinc per year. That production is for sale worldwide, including the Community, but excluding the United States where bacitracin is produced at another of its factories. The applicant states that, during the fermentation process needed to produce bacitracin zinc, a broth containing the active ingredient is held in a tank following the necessary time in the main fermenter. From that holding tank a specified amount of the broth is diverted for use in the production of 'human grade' bacitracin. Some (...)% of the active ingredient is removed from that extract and the remainder returned to the holding tank for use in the production of Albac. The Oslo facility also produces approximately (...) kg of human grade bacitracin per year. With that production, the capacity of the Oslo facility is fully utilised.

87 From 1 July 1999 bacitracin zinc will be produced for sale in markets outside the Community and human grade bacitracin will be produced for sale in markets II - 2063

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worldwide. Production at the Oslo factory will have to be reduced as a result by (...) kg of active ingredient per year, that is to say approximately (...)% of capacity.

88 The Berntsen report forecasts that, following the Community ban, the unit production costs for a kilogram of bacitracin zinc at the Oslo factory will increase by (...)%, because of the increased level of fixed costs (salaries and overheads).

89 The Berntsen report also describes the effect of the ban on the profitability of the factory and shows that, at current unit cost levels and current average sales prices, the applicant will lose a substantial amount of revenue and be faced with substantial unabsorbed overheads which will exacerbate the loss of gross profit.

93 Finally, spare capacity at the Oslo factory could be utilised to produce a new product, but that possibility presupposes not only that the product will be developed but also that it will obtain authorisation and be a commercial success.

— Consequences of the ban outside the Community

94 The applicant claims that, as a result of the Community ban, non-member countries, including countries which are candidates for accession, could ban bacitracin zinc. It points out that, when avoparcin was banned in the Community, Hungary, Poland, Romania, the Czech Republic, Bulgaria and Ukraine fell into line with that ban. Furthermore, following the Community ban, Korea, Japan and Thailand decided to impose one themselves. In the present case, measures banning the use of bacitracin zinc in animal feed have already been adopted in Poland, Romania and Bulgaria and are about to be adopted in the Czech Republic. In particular, the announcement of the ban by the Polish authorities II - 2065

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stated that it was 'with reference to the [contested] regulation'. The applicant sells Albac in all those countries. In addition, a possible ban is currently being considered by the New Zealand and Australian authorities.

95 Annual production of bacitracin zinc at the Oslo factory would therefore have to be cut further, thereby worsening the financial results of that operation which are already forecast to deteriorate as a result of the ban in the Community. The Berntsen report contains the financial analyses in that regard.

markets speciality human pharmaceutical and animal health products. It currently has five manufacturing facilities in the United States, four in Norway (including the Oslo factory), one in Denmark and one in Indonesia. It employs approximately 2 600 people worldwide. In addition, it claims to be the largest manufacturer of generic liquid and topical pharmaceuticals in the United States, the leading Nordic producer of international finished pharmaceuticals, a dominant worldwide supplier of general important specific antibiotics, a leading producer of animal health additives and the largest producer of fish vaccines worldwide. As regards, more specifically, its Animal Health Division outside the European Union, it claims to have a dominant position in the United States and a strong and growing international presence in Latin America and Asia. In view of its size, its international presence and the diversity of its products, the Council considers that the applicant's contentions concerning the impact of the ban on its business are not realistic.

99 First of all, while it is not in dispute that the applicant will cease to sell bacitracin zinc in the Community, it has not been demonstrated that the Community ban will necessarily bring to an end its animal health business either within or outside the European Union. The Council maintains that the alleged damage within the European Union is grossly overestimated and exaggerated, because the projected loss of sales in 1999-2009 is based on the growth rates for 1997-98, years in which the applicant took over the market share held by a product which had been withdrawn from the market.

102 Second, the Council points out that damage of a purely financial nature cannot in principle be regarded as irreparable, or reparable only with difficulty, if it can ultimately be the subject of financial compensation (order of 1 October 1997 in Case T-230/97 R Comafrica and Dole Fresh Fruit Europe v Commission [1997] ECR II-1589). In the present case, the applicant has failed to show that the alleged damage to the Oslo factory and to its animal health business is such as to place its very existence in jeopardy. That would be the case if the applicant's activities were limited to the manufacture of Albac and the entire market for that product were suddenly to disappear because of the contested regulation. However, on the basis of information placed on the Internet by the applicant, production at the Oslo factory is not limited to bacitracin zinc as a feed additive. It produces 'animal grade' bacitracin zinc for markets other than those of the European Union and United States, 'animal grade' bacitracin zinc for therapeutic use, 'human grade' bacitracin zinc and other antibiotic products. In addition, the applicant is currently developing new products which could be produced by the Oslo factory.

103 Furthermore, harm resulting from decisions adopted by non-member countries to ban bacitracin zinc cannot be taken into account.

104 Finally, the Council produced at the hearing a copy of the press release dated 14 December 1998 which the applicant issued following the adoption of the contested regulation. II - 2068

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Balance of interests

107 The applicant then points to the differences between the present case and the case which gave rise to the order of 12 July 1996 in United Kingdom v Commission, cited above, where the United Kingdom had applied for suspension of operation of the Commission decision intended to protect public health against bovine spongiform encephalopathy. In particular, the risk to human health in United Kingdom v Commission lay in the transmission of a fatal disease affecting humans for which there was no known cure at the time, while the risk invoked in the present case is a possible build-up of resistance to a medicinal product which has no significant actual or potential use in human medicine. There is no life- threatening disease for which bacitracin zinc is prescribed. The applicant states in that regard that the use of bacitracin zinc is necessarily limited because of its nephrotoxicity. For that reason it is not effective as a treatment for infections caused by vancomycin-resistant enterococci, contrary to the statement in recital 22 in the preamble to the contested regulation. Moreover, alternative products are available in respect of its current use. It is clear from scientific literature as well as its current use and its manner of prescription that it is very little used today. Thus, the authorisation of bacitracin zinc as an additive in feedingstuffs II - 2069

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presents no risk to human health. In any event, it is not established that the use of bacitracin zinc in feedingstuffs may lead to increased resistance to that antibiotic in humans — the evidence of over 40 years of experience and the expert's report annexed to the application suggest the contrary.

1 1 1According to the Council, the balance of interests militates in favour of the maintenance of the contested regulation, inasmuch as the interest in having the contested measure maintained is not readily comparable to the applicant's interest in having its operation suspended (order of 12 July 1996 in United Kingdom v Commission, cited above, paragraph 90, and order of the President of the Court of Justice of 24 September 1996 in Joined Cases C-239/96 R and C-240/96 R United Kingdom v Commission [1996] ECR 1-4475). Even if it were acknowledged that there may be damage to the applicant's interests, that damage cannot outweigh the serious harm to public health which is liable to be caused by suspension of the contested decision, and which could not be remedied if the main action were subsequently dismissed (order of 12 July 1996 in United Kingdom v Commission, cited above, paragraph 92). Any possible damage to the applicant's commercial interests cannot outweigh the potentially serious harm to public health which could be caused by permitting the routine use of bacitracin zinc as a growth promoter to continue.

112 The parties intervening in support of the form of order sought by the Council endorse those arguments.

Findings of the Court

Admissibility

113 In accordance with the second paragraph of Article 104(1) of the Rules of Procedure, an application for the adoption of interim measures is admissible only if it is made by a party to a case before the Court of First Instance. That rule is not a mere formality; it presupposes that the main action which is accompanied by the application for interim measures is capable of being properly considered by the Court. II - 2071

116In the present case, the contested regulation withdraws four specified antibiotics from the list in Annex B to Directive 70/524 and prohibits their sale in all the Member States of the Community with effect, pursuant to Article 3, from 1 January 1999 or 1 July 1999. As is apparent from recital 27 in the preamble to the contested regulation, the reason for the withdrawal of authorisation for the four antibiotics is the protection of human health; it is therefore aimed not only at the manufacturers of the products concerned but also at those using them and, more generally, at the entire population of the European Union. That regulation is therefore in the form of a measure having general application within the meaning of Article 189 of the EC Treaty (now Article 249 EC). II - 2072

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117 However, the fact that a provision is, by its nature and scope, of a legislative nature does not prevent it from being of individual concern to natural or legal persons if it affects them by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and, by virtue of those factors, distinguishes them individually just as in the case of the addressee of a decision (Case C-309/89 Codorniu v Council [1994] ECR 1-1853, paragraph 19, and order of 26 March 1999 in Case T-114/96 Biscuiterie-Confiserie LOR and Confiserie du Tech v Commission [1999] ECR 11-913, paragraph 30).

118It suffices in that regard to note in the context of the present proceedings, first, that the applicant is in a special situation, since it is the sole producer of bacitracin zinc in the European Economic Area and its leading supplier there, and second, that it risks being adversely affected by the contested regulation by reason of its position as the only undertaking which, before 1 October 1998, lodged a new application for authorisation with a view to the re-evaluation of bacitracin zinc as an additive linked to a person responsible for putting it into circulation, in accordance with Article 9g(2) of Directive 70/524, as inserted by Article 1 of Directive 96/51.

123 The Council, by contrast, maintains that the principal objective of the contested regulation, in withdrawing authorisation for four antibiotics, was to ensure the protection of human health against the actual and potential risks of increased antimicrobial resistance in human medicine resulting from the regular use of antibiotics in the raising of animals. That measure must, it contends, be seen as a precautionary safeguard which can be reviewed in the light of the investigations and the surveillance programme. The Council, supported by the Commission and the intervening Member States, considers, in essence, that, where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent. In the present case, although the experts are unable to quantify the health risk, reports such as those of the WHO, the House of Lords Select Committee and the Health Council of the Netherlands, together with the Copenhagen recommendations on antimicrobial resistance, reveal the justification and the need for the adoption of measures to put an end to the use of antimicrobial agents as growth promoters for livestock where those agents are or could be used as a drug for human use.

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124 It must be observed in that regard that, if the Court were in fact to find that the Council was mistaken in its interpretation of the criteria for the application of the precautionary principle, such a finding would constitute, in the circumstances of this case, a crucial factor for the purposes of assessing the extent of the risk to human health which may justify the withdrawal of authorisation in respect of bacitracin zinc as an additive in animal feed.

being reparable only with difficulty, if it can ultimately be the subject of financial compensation (order of the President of the Court of Justice of 18 October 1991 in Case C-213/91 R Abertal and Others v Commission [1991] ECR 1-5109, paragraph 24, and order of the President of the Court of First Instance of 7 November 1995 in Case T-168/95 R Eridania and Others v Council [1995] ECR 11-2817, paragraph 42).

129 Under those principles, the suspension sought could be justified, in the circumstances of the present case, only if it appeared that, in the absence of such relief, the applicant would be placed in a situation which could endanger its very existence or irremediably affect its market share.

130 In order to determine whether the operation of the contested regulation is likely to endanger the applicant's existence, it is necessary to ascertain the effects which it may have, first, on the Oslo factory, and second, on the applicant's financial viability.

131 It must be stated at the outset that the operation of the contested regulation will not cause all production of Albac to cease or inevitably lead to the closure of the Oslo factory.

132 Since the effect of the contested regulation is to ban the sale of bacitracin zinc used as an additive in animal feed in the Community, the applicant will be able to continue to produce Albac for sale in markets outside the Community. In that regard, the value of sales of Albac in the Member States of the Community, calculated on the basis of the figures set out in the table on page 6 of the Berntsen report, accounted for (...)% of the total value of sales of Albac worldwide in 1998, and not (...)% as indicated on page 4 of the Berntsen report; sales of Albac outside the Community therefore accounted for (...)% of the total value of sales. II - 2076

135 Accordingly, since a decision not to grant suspension will not inevitably lead to the discontinuance of production of bacitracin zinc for animal feed or to the cessation of the other production activities at the Oslo factory, it must be held that the operation of the contested regulation will not result in the factory's closure. II - 2077

ORDER OF 30. 6. 1999 — CASE T-70/99 R

136 As regards the further question whether the inability to sell Albac in the Community prejudices the applicant's financial viability, it should be noted that, since the ban on that product is limited to the Community, the applicant will still be able to market it outside the Community after 1 July 1999. Having regard to the results recorded in 1998 (see paragraph 132 above), it is possible that sales of Albac will enable it to realise (...)% of the turnover achieved by it from sales of that product in 1998.

137 Furthermore, it was stated at the hearing, in reply to a question from the Court, that turnover from sales of Albac throughout the world accounted for 5% of the applicant's total turnover.

138 Consequently, the financial harm which the applicant will suffer will not prevent it from continuing to pursue its activities pending judgment in the main action.

139 As to the effect which that prohibition will have on market share, a distinction must be drawn between markets outside the Community and the Community market.

142 It should be noted in that regard, first, that the ban is not definitive in nature, since, according to Article 2 of the contested regulation, its provisions are to be re-examined before 31 December 2000 on the basis of the results of the various investigations concerning the development of resistance following the use of the antibiotics concerned and the surveillance programme concerning microbial resistance in animals which have received antibiotics.

143 Furthermore, Alpharma has an excellent reputation in the animal feed industry, as a producer of high quality products (Brakke letter, p. 4). Sales of Albac in 13 Member States increased by an average of (...)% per year, in value and in volume, during the period from 1994 to 1998 (Berntsen report, p. 7). In addition, on the assumption that the contested regulation had not been adopted, the Berntsen report indicates that sales would have increased in volume by 8% per year during the period from 1999 to 2009. It follows, first, that doubt cannot be cast on the II - 2079

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applicant's reputation as a whole merely because of the ban on the sale of Albac, which is just one of the products manufactured by it, and second, that, given the commercial success with Community stock farmers which bacitracin zinc has enjoyed in the past and is anticipated for the future, the view cannot be taken that the applicant will no longer be able to regain the share of the Community market which bacitracin zinc for use in animal feed held before the ban, should the contested regulation be annulled by the Court.

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relief can be taken into consideration by the Court hearing the application for interim measures only when balancing the interests at stake. Consequently, the possible damage to the distributors of Albac established in the various Member States, pleaded by the applicant, is to be taken into account only when that factor is considered for the purposes of suspension of operation.

147 Having regard to all the foregoing, it must be concluded that the applicant has not succeeded in showing that it would suffer serious and irreparable damage if operation of the contested regulation were not suspended.

148 In any event, even if the applicant succeeded in establishing beyond any doubt the existence of serious and irreparable damage, the Court would still be required, in the context of the present application, to weigh the interest of the applicant in obtaining suspension of the ban on the sale of bacitracin zinc in the Community against the interest of the other parties in securing its continuance in force.

149 In the context of its examination of an application for interim measures, the Court is required to determine whether the possible annulment of the contested act by the Court hearing the main action would allow the situation brought about by its immediate implementation to be reversed and, conversely, whether suspension of the operation of that act would be such as to prevent its being fully effective in the event of the main application being dismissed (see, in particular, the order of the President of the Court of Justice of 11 May 1989 in Joined Cases 76/89 R, 77/89 R and 91/89 R RTE and Others v Commission [1989] ECR 1141, paragraph 15, the order of 12 July 1996 in United Kingdom v Commission, cited above, paragraph 89, and the order of the President of the Court of First Instance of 21 March 1997 in Case T-41/97 R Antillean Rice Mills v Council [1997] ECR II-447, paragraph 42).

154 In the present case, without in any way prejudging the assessment to be made by the Court concerning the pleas raised by the applicant in the main action, it must be observed that the stated objective of the withdrawal of authorisation in respect of bacitracin zinc is to combat the risks of increased antimicrobial resistance in II - 2082

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human medicine resulting from the regular use of that antibiotic in the raising of animals. Consequently, that risk of increased antimicrobial resistance in human medicine is based on the assumption that bacteria resistant to bacitracin zinc in animals are transmissible to humans.

155 The documents before the Court substantiate that assumption.

156 Thus, in the report of the conference held in Berlin in October 1997 on 'The Medical Impact of the Use of Antimicrobials in Food Animals', the WHO stated (p. 1):

'Certain antimicrobials used for treatment or growth promotion in agriculture are also used for disease control in humans. Others select for cross-resistance in bacteria to antimicrobials used in human medicine. Microbiological and clinical evidence is mounting that resistant bacteria or resistance determinants might be passed from animals to humans, resulting in infections that are more difficult to treat. With an increase in the prevalence and distribution of antimicrobial- resistant infections in hospitals and the community, the question has been raised as to how this escalation of resistance could have been influenced by the use of antimicrobials in livestock production.

'Bacitracin and everninomycin are two "new" antibiotics under development for the treatment of patients with VRE [vancomycin-resistant enterococcus] and MRSA [methicillin-resistant Staphyllococcus aureus] infections which are currently generating a great deal of interest. In the past, the use of bacitracin in humans has been confined to topical use in the treatment of patients with infections of the skin or the mucous membrane. Recently, though, it has entered experimental use for the treatment of patients infected by VRE (Chia J.K., Nakata M.M., Park S.S. et ai, Use of Bacitracin Therapy for Infection due to II - 2084

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Vancomycin-resistant Enterococcus faecium, Clin Inf Dis 1995; 21:1520). However, this antibiotic is additionally used as a growth promoter in livestock farming. In the United States, relatively low resistance rates (up to 17 per cent) have so far been found in staphylococci, streptococci and enterococci... Never- theless, if this substance is used as a growth promoter, the possibility of resistance increasing cannot be excluded.'

160 The report also states:

'Bacitracin and everninomycin have recently been introduced for the treatment of patients infected by VRE [vancomycin-resistant enterococcus] or MRSA [methi- cillin-resistant Staphyllococcus aureus]. However, bacitracin is used as a growth promoter, while everninomycin is closely related to the growth promoter avilamycin, so the possibility of problems arising in the future as a result of developing resistance to these agents cannot be excluded' (pp. 62 and 63).

165 In those circumstances, since it is not impossible, according to the sources quoted, that bacteria which have become resistant due to the feeding to livestock of antibiotic additives such as bacitracin zinc may be transmissible from animals to humans, the risk of increased antimicrobial resistance in human medicine on account of the use of bacitracin zinc in animal feed cannot be ruled out. If increased antimicrobial resistance in human medicine were to occur, the potential consequences for public health would be very serious, since, if they developed resistance, certain bacteria could no longer be effectively combated by human medicines capable of being used for that purpose, including bacitracin. In that regard, it is apparent from the case-file that bacitracin could be used in the future to combat resistant bacteria (report of the Health Council of the Netherlands, II - 2086

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pp. 42 and 65; study submitted by Sweden to the Commission in February 1998, cited in paragraph 11 of the Commission's statement in intervention). At the hearing, Professor F. Baquero confirmed this analysis in his evidence on behalf of the Commission. Finally, that substance was authorised in 1997 by the United States health authorities for use by injection, as is apparent from a document produced to the Court on the day of the hearing.

166 In those circumstances, without prejudging the examination by the Court 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 is enough in itself to justify taking into account, in the balancing of interests, the protection of human health. Consequently, the applicant cannot found an argument on the differences between the present case and that which gave rise to the order of 12 July 1996 in United Kingdom v Commission, since the fact that the fatal nature of the disease transmissible to humans and the grave hazard to human health were taken into account in that case does not mean that measures cannot be adopted by the Community institutions in the absence of any serious factor of that kind.

2. The costs are reserved.

Luxembourg, 30 June 1999.

H.Jung B. Vesterdorf Registrar President

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