Judgment_paragraph 5 · Pharos SA v Commission of the European Communities (C-151/98 P)

5The facts as set out in the contested judgment are as follows:10 The applicant is a company specialising in biotechnology. It is active inter alia in the pharmaceuticals industry.11 In 1994 its pharmaceutical research resulted in the development of a veterinary product called “Smoltine” designed to help salmon make the transition from fresh water to sea water. The pharmacologically active substance in Smoltine is somatosalm, a substance belonging to the somatotropin family.12 On 17 October 1994 the applicant submitted an application for the inclusion of somatosalm in Annex II to Regulation No 2377/90 (hereinafter “Annex II”).13 Having verified that the application had been submitted in correct form, the Commission referred the application for examination to the CVMP, pursuant to Article 6(2) of Regulation No 2377/90.14 By letter of 13 April 1995 it informed the applicant that the CVMP had recommended that somatosalm be included in Annex II. It added that the draft measures to be taken, drawn up on the basis of the CVMP's proposal, would be sent to the Adaptation Committee for adoption, in accordance with Article 8 of Regulation No 2377/90.15 By letter of 31 August 1995 it informed the applicant that it had referred to the Adaptation Committee a draft regulation including somatosalm in Annex II, but that, at its meeting, the Committee deleted somatosalm from the draft.16 On 16 October 1995 it referred to the Adaptation Committee a new draft regulation including somatosalm in Annex II. However, that draft did not receive the assent of a qualified majority of the Adaptation Committee to the measures proposed.17 Four Member States opposed the measures, taking the view that the moratorium on Bovine Somatotropin (hereinafter “BST”), imposed by Council Decision 90/218/EEC of 25 April 1990 concerning the administration of Bovine Somatotropin (BST) (OJ 1990 L 116, p. 27), as last amended by Council Decision 94/936/EC of 20 December 1994 (OJ 1994 L 366, p. 19), would be undermined indirectly if somatosalm, which is also a somatotropin, were included in one of the annexes to Regulation No 2377/90. Moreover, six Member States abstained from the vote in question.18 On 6 March 1996, the applicant sent a registered letter to the Commission, formally calling upon it to act by taking “the necessary steps, in accordance with Article 175 of the Treaty, to ensure that the procedure for including somatosalm in ... Annex II ... is completed as soon as possible”.19 On 23 April 1996 the Commission sent a letter to the CVMP informing it of its decision to stay the procedure for including somatosalm in Annex II until further scientific information had been obtained. It explained that there had been a certain amount of opposition to somatosalm in the Adaptation Committee because the substance could be used to boost growth. It therefore asked the CVMP for a further opinion as to whether abuses of the product were possible.20 By letter of 14 May 1996 the Commission informed the applicant that it had decided to ask the CVMP for that further opinion before continuing with the procedure for including somatosalm in one of the annexes to Regulation No 2377/90.21 By letter of 27 June 1996 the CVMP stated in reply to the request for a further opinion that, following a specific study, it had concluded that the risk that somatosalm might be abused to boost growth could be considered to be non-existent.22 On 25 September 1996, following that reply, the Commission sent the Council a new proposal for a regulation including somatosalm in Annex II.23 The Council did not act on that proposal within the period of three months provided for by Article 8(3)(c) of the Regulation.’