Keywords

Summary



Keywords

1. Appeals - Pleas in law - Plea alleging incorrect appraisal of the facts - Inadmissibility - Review by the Court of Justice of the appraisal of the evidence submitted to the Court of First Instance - Possible only where the clear sense of the evidence has been distorted

(Art. 225 EC; EC Statute of the Court of Justice, Art. 51)

2. Appeals - Admissibility - Assessment in relation to the case at issue

(EC Statute of the Court of Justice, Art. 49)

3. Approximation of laws - Proprietary medicinal products - Marketing authorisation - Evaluation of the products - Assessment of their harmfulness and efficacy - Examination in relation to each other - Ongoing nature of the assessment

(Council Directives 65/65, Art. 5, and 75/318, annex)

4. Approximation of laws - Proprietary medicinal products - Marketing authorisation - Withdrawal of authorisation - Discretion of the Community authorities - Judicial review - Limits

(Council Directives 65/65, Art. 11, and 75/319, Arts 13 and 14)

Summary

1. The Court of First Instance has exclusive jurisdiction to find the facts, save where a substantive inaccuracy in its findings is attributable to the documents submitted to it, and to appraise those facts. That appraisal thus does not, save where the clear sense of the evidence has been distorted, constitute a point of law which is subject, as such, to review by the Court of Justice on appeal.

( see para. 50 )

2. The conditions governing the admissibility of appeals laid down by Article 49 of the Statute of the Court of Justice are assessed in relation to the case at issue and that alone. The fact that the grounds of an order of the Court of First Instance which has become definitive are identical to those of an order subject to appeal does not prevent the appellant from contesting such grounds.

( see para. 53 )

3. Under Article 5 of Directive 65/65 relating to proprietary medicinal products, the evaluation of every medicinal product relates to its efficacy, its harmlessness and its quality. Compliance with those three conditions is intended to protect public health. The very concept of the protection of public health means that the medicinal product in question not only must not be harmful but also must be effective. The degree of harmfulness which the competent authority may regard as acceptable thus depends on the benefits which the medicinal product is considered to provide. As stated in the seventh and eighth recitals in the preamble to Directive 75/318 relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products, the concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other. Accordingly, the reasons which have led a competent authority to preserve a marketing authorisation for a medicinal product notwithstanding certain harmful effects may cease to apply if that authority considers that the benefits justifying such an authorisation, that is to say the existence of a therapeutic effect, are no longer present. As stated in the introduction to the annex to Directive 75/318, as amended by Directive 91/507, after issue of the marketing authorisation any new data or information are to be submitted to the competent authorities in order to monitor the benefit/risk assessment.

( see paras 62, 65 )

4. Any decision withdrawing a marketing authorisation which is adopted in accordance with the procedure laid down in Articles 13 and 14 of Directive 75/319 relating to proprietary medicinal products must comply with the substantive conditions under Article 11 of Directive 65/65, which relate to the efficacy, safety and quality of the medicinal product. This type of decision is thus the outcome of complex assessments in the medico-pharmacological field. In principle, such assessments are subject to limited judicial review. Where a Community authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a limited judicial review in the course of which the Community judicature may not substitute its assessment of the facts for the assessment made by the authority concerned. Thus, in such cases, the Community judicature must restrict itself to examining the accuracy of the findings of fact and law made by the authority concerned and to verifying, in particular, that the action taken by that authority is not vitiated by a manifest error or a misuse of powers and that it did not clearly exceed the bounds of its discretion.

( see paras 89-90 )