The case of BASF v Commission is of relevance to holders of marketing authorizations (MAs) seeking to challenge decisions made by EU institutions to vary or withdraw MAs, as it highlights the wide discretion afforded to such institutions (and to the EU legislature) by the General Court and the consequently restricted judicial review of these decisions. The case also touches upon questions of admissibility of evidence in the context of actions for the annulment of decisions regarding MAs.
The applicant, BASF AS, brought an action on July 9, 2019, pursuant to Article 263 TFEU for the annulment of the European Commission Implementing Decision C(2019) 4336 of June 6, 2019 (the contested decision). The Commission decision in question requested the Member States to vary the MAs for medicinal products containing omega-3 acid ethyl esters by removing the indication concerning the oral use of those medicinal products in secondary prevention after myocardial infarction, including that of BASF AS.
On September 23, 2020, the General Court (Eighth Chamber) dismissed the action and ordered BASF AS to pay the costs, including the costs relating to the interlocutory proceedings.
BASF AS sought to rely on two pleas in the annulment application alleging (i) an infringement of the first paragraph of Article 116 of Directive 2001/83 on the basis of manifest error of assessment of both the risks and benefits of products containing omega-3 acid ethyl esters, and (ii) an infringement of the principle of proportionality.
Alleged infringement of Article 116 of Directive 2001/83
The Court noted that an applicant cannot merely make vague and imprecise assertions that a study is unsubstantiated. Instead, it must either highlight the lack of internal consistency of the Committee for Medicinal Products for Human Use (the CHMP) opinion or its reasoning in relation to that study, or demonstrate that the study lacked probative value or relevance for the purposes of the re-examination of the previously-granted MA, which BASF had failed to do. The lawfulness of the contested decision cannot be examined by taking into consideration new information or evidence arising after its adoption.
The Court held that the Commission, relying on the opinion of the CHMP and the data on which it was based, was entitled to consider that the risk-benefit balance of the medicinal products was unfavourable. Further, the Court noted that the conditions of the first paragraph of Article 116 are alternative and not cumulative; it is sufficient that one of those conditions is satisfied for the competent authorities to be able to suspend, withdraw, or vary an MA. The Court further added that the granting of an MA cannot have the effect of “freezing” the situation and preventing the CHMP from calling into question the MA if the conditions for granting the MA are no longer met.
The Court therefore rejected the allegation of infringement of Article 116.
Alleged breach of the principle of proportionality
BASF AS argued that in order not to infringe the general EU law principle of proportionality, the Commission should have selected the least onerous measure with regard to the medicinal products.
However, the Court stated that the EU legislature has a discretion in this area, and decisions concerning the application of the criteria of efficacy, safety, and quality of a medicinal product are subject to limited judicial review. Therefore, where an EU institution is called upon to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a judicial review restricted to verifying that the measure in question is not based on a manifest error or a misuse of powers and that the competent authority did not clearly exceed the bounds of its discretion.
Given that the Commission did not make a manifest error of assessment as regards the risk-benefit balance in question, it did not infringe the principle of proportionality by deciding to require the withdrawal of the MA for the medicinal products.
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