Order of the President of the Court of First Instance of 31 October 2000. - Bruno Farmaceutici SpA and Others v Commission of the European Communities. - Proceedings for interim relief - Withdrawal of marketing authorisation for medicinal products for human use containing amfepramone - Directive 75/319/EEC - Urgency - Need to balance interests. - Case T-76/00 R.



European Court reports 2000 Page II-03557

Pub.RJ Page Pub somm



Summary

Parties

Grounds

Operative part



Keywords

1. Applications for interim measures - Suspension of operation of a measure - Conditions for granting - Urgency - Serious and irreparable damage - Decision withdrawing marketing authorisation for a medicinal product

(Art. 242 EC; Rules of Procedure of the Court of First Instance, Art. 104(1) and (2))

2. Applications for interim measures - Suspension of operation of a measure - Conditions for granting - Balancing of all the interests involved - Decision withdrawing marketing authorisation for a medicinal product

(Art. 242 EC; Rules of Procedure of the Court of First Instance, Art. 104 (1) and (2))

Summary

1. The damage which might be occasioned by the immediate operation of a decision of the Commission concerning the withdrawal of marketing authorisations for certain medicinal products is serious and irreparable, for the holder of a marketing authorisation for a medicinal product concerned, where it is shown, first, that the complete withdrawal from the market of the medicinal product in question entails the risk that substitute medicinal products will very probably take its place and that it will be impossible for the holder of the authorisation to restore confidence in the product even if the statements that the product withdrawn presents a danger to patients are subsequently disproved and, second, that if the decision were to be annulled by the court hearing the main application, the financial damage suffered by the holder because of a fall in sales as a result of loss of confidence in the product could not be quantified sufficiently completely.

( see paras 42-44 )

2. Where, on an application for suspension of the operation of a measure, the judge hearing the application balances the various interests involved, he must determine whether later annulment of the contested measure by the Court when ruling on the main application would allow the situation which would have been brought about by the immediate operation of the measure to be reversed, and, conversely, whether suspension of operation of the measure would prevent it from being fully effective in the event of the main application being dismissed.

In the context of an application for suspension of the operation of a Commission decision concerning the withdrawal of marketing authorisation for certain medicinal products, while the requirements of the protection of public health must unquestionably be given precedence over economic considerations when balancing the competing interests, mere reference to the protection of public health cannot exclude an examination of the circumstances of the case, in particular of the relevant facts.

The balance of interests favours suspension of the operation of such a decision where, first, it appears highly probable that its operation would entail the definitive loss of the applicant's position in the market even if the court hearing the main application were to annul the decision and, second, the Commission has not been able to show why the protective measures contained in a previous decision based on identical data, and consisting solely in a change to the compulsory information which must be included in national authorisations, have proved to be insufficient to protect public health.

( see paras 46-51 )

Parties

In Case T-76/00 R,

Bruno Farmaceutici SpA, established in Rome (Italy),

Essential Nutrition Ltd, established in Brough (United Kingdom),

Hoechst Marion Roussel Ltd, established in Uxbridge (United Kingdom),

Hoechst Marion Roussel SA, established in Brussels (Belgium),

Marion Merrell SA, established in Puteaux (France),

Marion Merrell SA, established in Barcelona (Spain),

Sanova Pharma GmbH, established in Vienna (Austria),

Temmler Pharma GmbH & Co. KG, established in Marburg (Germany),

represented by B. Sträter, Rechtsanwalt, Bonn, with an address for service in Luxembourg at the Chambers of Bonn and Schmidt, 7 Val Sainte-Croix,

applicants,

v

Commission of the European Communities, represented by H. Støvlbæk, of its Legal Service, acting as Agent, and B. Wägenbaur, of the Brussels Bar, with an address for service in Luxembourg at the office of C. Gómez de la Cruz, of its Legal Service, Wagner Centre, Kirchberg,

defendant,

APPLICATION for suspension of operation of the Commission decision of 9 March 2000 concerning the withdrawal of marketing authorisations for medicinal products for human use which contain amfepramone (C(2000) 453),

THE PRESIDENT OF THE COURT OF FIRST INSTANCE

OF THE EUROPEAN COMMUNITIES

(The grounds of the order are not reproduced.)

Grounds

(The grounds of the order are not reproduced.)

Operative part

hereby orders:

1. Operation of the Commission decision of 9 March 2000 concerning the withdrawal of marketing authorisations for medicinal products for human use which contain amfepramone (C(2000) 453) is suspended in relation to the applicants.

2. Costs are reserved.