Keywords

Summary



Keywords

1. Actions for annulment — Interest in bringing proceedings — None — (Art. 230, fourth para., EC)

2. Approximation of laws — Uniform laws — Community procedures for the authorisation and supervision of medicinal products — Regulation No 2309/93 — Central marketing authorisations — Requirement for a high level of health protection — Whether observations of persons other than the applicant may be taken into account — Admissibility — Scope — (Art. 152 EC; Council Regulation No 2309/93, Art. 11)

3. Approximation of laws — Uniform laws — Community procedures for the authorisation and supervision of medicinal products — Regulation No 2309/93 — Central marketing authorisations — Assessment of scientific data — Bilateral procedure between the applicant and the Community administration — (Council Regulation No 2309/93)

4. Approximation of laws — Uniform laws — Community procedures for the authorisation and supervision of medicinal products — Regulation No 2309/93 — Central marketing authorisations — Whether the professional reputation of a third person may be taken into account — Not permitted — (Council Regulation No 2309/93, Art. 68)

Summary

1. If the applicant has no interest in bringing proceedings, it will be unnecessary for the Court to examine whether the contested decision is of direct and individual concern to him within the meaning of the fourth paragraph of Article 230 EC.

see para. 66

2. Pursuant to Article 152 EC, a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities. That provision implies that the Community institutions must ensure that their decisions are taken in the light of the best scientific information available and that they are based on the most recent results of international research.

Pursuant to Article 11 of Regulation No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, the Commission, before authorising the placing of a medicinal product on the market, must verify that the particulars and documents provided by the applicant for marketing authorisation are indeed correct and that they adequately demonstrate the quality, safety and efficacy of that product.

None of the provisions of the applicable Community rules prohibits the Commission, prior to granting a marketing authorisation for a medicinal product, from following a procedure during which persons other than the applicant for marketing authorisation are able to submit their observations so as to enable it to fulfil its duty to check, in the interest of public health, that all the information relating to the scientific evaluation of the product in question, whether it be favourable or unfavourable to the product, has indeed been made available to it.

Consequently, in a situation in which a person played an essential role in the work towards the perfecting of a proprietary medicinal product and in which the information which he sent to the Committee for Proprietary Medicinal Products enabled the Commission to confirm that the particulars and documents on the basis of which the marketing authorisation was authorised were both complete and correct, the Commission was required, in the interest of public health, to examine that information. If it did not do so, the Commission would not be in a position to fulfil its obligations under Regulation No 2309/93.

In those specific circumstances, the applicant would have had an interest in bringing proceedings against a Commission decision addressed to him if it had refused to examine the information provided by him in the course of the procedure for the scientific assessment of the medicinal product concerned or there had been an implicit decision to reject that information, which would have been the case if the Commission had adopted the decision to grant marketing authorisation without having examined that information. He would have been entitled to contest the legality of either of those decisions before the Court of First Instance.

Consequently, the applicant no longer has an interest in bringing proceedings to contest the legality of the contested decision is so far as concerns the examination of the correctness and completeness of the scientific information relating to the medicinal product in question, if the information sent by the applicant directly to the Committee for Proprietary Medicinal Products was in fact examined and taken into account during the assessment procedure for the medicinal product.

see paras 68-69, 73, 80-81, 88, 92

3. Unlike other Community administrative procedures, in particular those in the area of the competition rules, during which third parties, that is to say parties interested in or potentially affected by any Commission decision, are entitled to be heard by the Commission before the decision is adopted, Regulation No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products establishes a purely bilateral procedure. It is a procedure between the applicant for marketing authorisation and the administration, during which the administration must take into account the applicant ' s interest in obtaining marketing authorisation and the public interest in the protection of human health. A third party is not entitled to participate in that procedure or set himself up as interlocutor of the Committee for Proprietary Medicinal Products and of the Commission in regard to the assessment of the scientific data relating to the product in question.

see para. 94

4. Since Article 68 of Regulation No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products does not permit the Commission to take into account, in a decision to grant marketing authorisation, the professional reputation of a third party, such a matter cannot be invoked by the applicant as conferring on him an interest in bringing proceedings for annulment of the decision.

see para. 98