30 June 1999

Orders of the President of the Court of First Instance in

Case T-13/99 R Pfizer Animal Health SA/NV v Council of the European Union and Case T-70/99 R Alpharma Inc. v Council of the European Union


The President of the Court of First Instance dismisses two applications for suspension of the operation of a Council regulation withdrawing virginiamycin and bacitracin zinc from the list of antibiotics authorised for use as additives in animal feed.

Pfizer Animal Health SA/NV, a company incorporated under Belgian law, is the sole producer of virginiamycin, an antibiotic manufactured in its factory at Rixensart (Belgium) and sold under the name "Stafac".

Alpharma Inc., established in the United States, produces an antibiotic known as bacitracin zinc, which it markets under the name "Albac".

Both virginiamycin and bacitracin zinc have been entered, in accordance with the procedures laid down for that purpose, in the list of additives which may be used in animal feed. When administered on a regular basis to livestock, those additives boost the animals' growth.

Virginiamycin belongs to a family of antibiotics some of which are used in human medicine. Bacitracin zinc is used in human medicine.

By its regulation adopted on 17 December 1998, the Council withdrew four antibiotics, including virginiamycin and bacitracin zinc, from the list of additives authorised for use in animal feed. That regulation consequently bans the sale of those antibiotics in all the Member States with effect from 1 July 1999 at the latest. The two manufacturers are contesting the legality of the regulation in proceedings before the Court of First Instance, and are seeking its annulment in whole or in part. In addition, they are applying for the immediate suspension of its operation.

In his assessment of those applications, the President of the Court finds that the contested regulation, despite its legislative character, may be of direct and individual concern to Pfizer and Alpharma, and proceeds to examine whether the criteria for suspension of its operation are satisfied.

The President observes, in the two orders made by him, that the applicant companies and the Council disagree fundamentally as to the circumstances in which the competent authorities may, as a precautionary step, adopt a measure withdrawing the authorisation of an antibiotic. That is an issue requiring very thorough examination, which cannot be undertaken in the context of the proceedings for interim relief.

Next, assessing the urgency of the need for Pfizer and Alpharma to have the regulation suspended, he examines whether there is a risk that its operation will cause those applicants serious and irreparable damage. In each of the cases, he considers that the suspension sought can be justified only if it is apparent that, unless it is granted, Pfizer and Alpharma will be placed in a situation which could endanger their very existence or irremediably affect their market shares.

The President finds that that is not the case. He observes that the operation of the regulation will not bring production of the antibiotics to an end, since it will still be possible to sell them on markets outside the Community, and that it has not been established that the entry into force of the regulation will result in the closure of Pfizer's Rixensart factory or Alpharma's plant in Oslo.

In addition, the President weighs up the significance, in terms of the applicants' respective turnover, of the sales of the two antibiotics for which authorisation has been withdrawn. He observes, in conclusion, that the ban is not definitive in nature, since the matter is to be re-examined before 31 December 2000 on the basis of the results of investigations which are currently being carried out.

The President concludes that the two undertakings have not shown that they will suffer serious and irreparable damage if the operation of the regulation, the annulment of which they are also seeking, is not immediately suspended.

In addition, the President weighs up the various interests at stake. He refers to the objective pursued by the new rules, namely to combat the risks of increased antimicrobial resistance in human medicine resulting from the use of certain antibiotics in the raising of animals. Weighing the damage which the undertakings concerned are liable to suffer against the public health risk, he stresses that the protection of public health must take precedence over economic considerations.

Finally, having regard to the evidence submitted to him, he observes that it is not impossible that bacteria which have become resistant due to the feeding to livestock of antibiotic additives such as virginiamycin and bacitracin zinc may be transmissible from animals to humans, and that the risk of increased antimicrobial resistance in human medicine resulting from their use in animal feed cannot therefore 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 certain medicines used in the treatment of humans, in particular the family of antibiotics which includes virginiamycin and bacitracin.

On the basis of the risk so identified, he dismisses the applications for suspension of the operation of the contested regulation.

N.B.: These orders do not in any way prejudge the final judgment of the Court in the main actions, which will be delivered at a later date.

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