{"attribution":{"source":"legal.exploreworldai.com","canonical":"https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-586-23-p-62023cj0586","cite_as":"NovaCopilot, legal.exploreworldai.com (https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-586-23-p-62023cj0586)","license":"https://legal.exploreworldai.com/revision","version":"legal-2026-10-13","fingerprint":"ewai:eu:a03983","proof":"sha256:0883ef203199f832a91a0fe087382438e751b95524232dabb9521a76b3b22c23","jurisdiction":"eu","lang":"en","publisher":"NovaCopilot by ExploreWorld Legal","terms":"https://legal.exploreworldai.com/om"},"brand_source":"Source: NovaCopilot","item":{"schema_version":"1.0.0","id":"eu:c-586-23-p-62023cj0586","jurisdiction":"eu","lang":"en","brand_source":"Source: NovaCopilot","brand":{"product":"NovaCopilot","platform":"ExploreWorldAI","infrastructure":"ExploreWorld Legal","infrastructure_url":"legal.exploreworldai.com","legal_entity":"Valkiv Ventures AB","permanent_url":"https://legal.exploreworldai.com/novacopilot","source":"Source: NovaCopilot","powered_by":"Powered by NovaCopilot","license":"https://legal.exploreworldai.com/licensvillkor"},"sections":[{"title":"62023CJ0586","paragraphs":[]},{"title":"JUDGMENT OF THE COURT (Eighth Chamber)","paragraphs":[]},{"title":"30 January 2025 (\n *1\n )","paragraphs":["para_4","para_5","para_6","para_7","para_8","para_9","para_10","para_11","para_12","para_13","para_14","para_15","para_16","para_17","para_18"]},{"title":"Judgment","paragraphs":[]},{"title":"1","paragraphs":["para_21"]},{"title":"Background to the dispute","paragraphs":[]},{"title":"2","paragraphs":["para_24","para_25","para_26","para_27","para_28","para_29","para_30","para_31","para_32","para_33","para_34","para_35","para_36"]},{"title":"Procedure before the General Court and the order under appeal","paragraphs":[]},{"title":"3","paragraphs":["para_39"]},{"title":"4","paragraphs":["para_41"]},{"title":"5","paragraphs":["para_43"]},{"title":"Forms of order sought before the Court of Justice","paragraphs":[]},{"title":"6","paragraphs":[]},{"title":"By his appeal, Mr Frajese. claims that the Court should:","paragraphs":["para_47","para_48","para_49","para_50","para_51","para_52","para_53","para_54"]},{"title":"7","paragraphs":["para_56"]},{"title":"The appeal","paragraphs":[]},{"title":"8","paragraphs":["para_59"]},{"title":"The first ground of appeal","paragraphs":[]},{"title":"Arguments of the parties","paragraphs":[]},{"title":"9","paragraphs":["para_63"]},{"title":"10","paragraphs":["para_65"]},{"title":"11","paragraphs":["para_67"]},{"title":"Findings of the Court","paragraphs":[]},{"title":"12","paragraphs":["para_70"]},{"title":"13","paragraphs":["para_72"]},{"title":"14","paragraphs":["para_74"]},{"title":"15","paragraphs":["para_76"]},{"title":"16","paragraphs":["para_78"]},{"title":"17","paragraphs":["para_80"]},{"title":"18","paragraphs":["para_82"]},{"title":"19","paragraphs":["para_84"]},{"title":"20","paragraphs":["para_86"]},{"title":"The second ground of appeal","paragraphs":[]},{"title":"Arguments of the parties","paragraphs":[]},{"title":"21","paragraphs":["para_90"]},{"title":"22","paragraphs":["para_92"]},{"title":"Findings of the Court","paragraphs":[]},{"title":"23","paragraphs":["para_95"]},{"title":"24","paragraphs":["para_97"]},{"title":"25","paragraphs":["para_99"]},{"title":"26","paragraphs":["para_101"]},{"title":"The third ground of appeal","paragraphs":[]},{"title":"27","paragraphs":["para_104"]},{"title":"First part of the third ground of appeal","paragraphs":["para_106"]},{"title":"28","paragraphs":["para_108"]},{"title":"29","paragraphs":["para_110"]},{"title":"30","paragraphs":["para_112"]},{"title":"31","paragraphs":["para_114"]},{"title":"32","paragraphs":["para_116","para_117"]},{"title":"33","paragraphs":["para_119"]},{"title":"34","paragraphs":["para_121"]},{"title":"35","paragraphs":["para_123"]},{"title":"36","paragraphs":["para_125"]},{"title":"37","paragraphs":["para_127"]},{"title":"38","paragraphs":["para_129"]},{"title":"39","paragraphs":["para_131"]},{"title":"40","paragraphs":["para_133"]},{"title":"Second part of the third ground of appeal","paragraphs":["para_135"]},{"title":"41","paragraphs":["para_137"]},{"title":"42","paragraphs":["para_139"]},{"title":"43","paragraphs":["para_141"]},{"title":"44","paragraphs":["para_143"]},{"title":"45","paragraphs":["para_145","para_146"]},{"title":"46","paragraphs":["para_148"]},{"title":"47","paragraphs":["para_150"]},{"title":"48","paragraphs":["para_152"]},{"title":"49","paragraphs":["para_154"]},{"title":"50","paragraphs":["para_156"]},{"title":"51","paragraphs":["para_158"]},{"title":"52","paragraphs":["para_160"]},{"title":"53","paragraphs":["para_162"]},{"title":"54","paragraphs":["para_164"]},{"title":"55","paragraphs":["para_166"]},{"title":"Third part of the third ground of appeal","paragraphs":["para_168"]},{"title":"56","paragraphs":["para_170"]},{"title":"57","paragraphs":["para_172"]},{"title":"58","paragraphs":["para_174"]},{"title":"59","paragraphs":["para_176","para_177"]},{"title":"60","paragraphs":["para_179"]},{"title":"61","paragraphs":["para_181"]},{"title":"62","paragraphs":["para_183"]},{"title":"63","paragraphs":["para_185"]},{"title":"64","paragraphs":["para_187"]},{"title":"65","paragraphs":["para_189"]},{"title":"66","paragraphs":["para_191"]},{"title":"67","paragraphs":["para_193"]},{"title":"68","paragraphs":["para_195"]},{"title":"69","paragraphs":["para_197"]},{"title":"70","paragraphs":["para_199"]},{"title":"71","paragraphs":["para_201"]},{"title":"72","paragraphs":["para_203"]},{"title":"73","paragraphs":["para_205"]},{"title":"74","paragraphs":["para_207"]},{"title":"75","paragraphs":["para_209"]},{"title":"76","paragraphs":["para_211"]},{"title":"The fourth ground of appeal","paragraphs":[]},{"title":"Arguments of the parties","paragraphs":[]},{"title":"77","paragraphs":["para_215"]},{"title":"78","paragraphs":["para_217"]},{"title":"79","paragraphs":["para_219"]},{"title":"80","paragraphs":["para_221"]},{"title":"Findings of the Court","paragraphs":[]},{"title":"81","paragraphs":["para_224"]},{"title":"82","paragraphs":["para_226"]},{"title":"83","paragraphs":["para_228"]},{"title":"84","paragraphs":["para_230"]},{"title":"85","paragraphs":["para_232"]},{"title":"86","paragraphs":["para_234"]},{"title":"87","paragraphs":["para_236"]},{"title":"Costs","paragraphs":[]},{"title":"88","paragraphs":["para_239"]},{"title":"89","paragraphs":["para_241"]},{"title":"On those grounds, the Court (Eighth Chamber) hereby:","paragraphs":["para_243"]},{"title":"Dismisses the appeal;","paragraphs":["para_245","para_246","para_247","para_248"]}],"paragraphs":[{"text":"62023CJ0586","paragraph_id":"para_1"},{"text":"JUDGMENT OF THE COURT (Eighth Chamber)","paragraph_id":"para_2"},{"text":"30 January 2025 (\n *1\n )","paragraph_id":"para_3"},{"text":"(Appeal – Public health – Medicinal products for human use – Marketing authorisation – Spikevax – Comirnaty – Action for annulment – Independence and impartiality of the Courts of the European Union – Failure to comply with procedural rules – Failure to give adequate reasons, and contradictory reasoning – Legal interest in bringing proceedings – Locus standi  – Fourth paragraph of Article 263 TFEU – Right to effective judicial protection)","paragraph_id":"para_4"},{"text":"In Case C‑586/23 P,","paragraph_id":"para_5"},{"text":"APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 25 September 2023,","paragraph_id":"para_6"},{"text":"Giovanni Frajese , residing in Rome (Italy), represented by O. Milanese and A. Montanari, avvocati,","paragraph_id":"para_7"},{"text":"appellant,","paragraph_id":"para_8"},{"text":"the other party to the proceedings being:","paragraph_id":"para_9"},{"text":"European\n Commission , represented by G. Gattinara and A. Sipos, acting as Agents,","paragraph_id":"para_10"},{"text":"defendant at first instance,","paragraph_id":"para_11"},{"text":"THE COURT (Eighth Chamber),","paragraph_id":"para_12"},{"text":"composed of N. Jääskinen, President of the Ninth Chamber, acting as President of the Eighth Chamber, M. Gavalec (Rapporteur) and I. Ziemele, Judges,","paragraph_id":"para_13"},{"text":"Advocate General: L. Medina,","paragraph_id":"para_14"},{"text":"Registrar: A. Calot Escobar,","paragraph_id":"para_15"},{"text":"having regard to the written procedure,","paragraph_id":"para_16"},{"text":"having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,","paragraph_id":"para_17"},{"text":"gives the following","paragraph_id":"para_18"},{"text":"Judgment","paragraph_id":"para_19"},{"text":"1","paragraph_id":"para_20"},{"text":"By his appeal, Mr Giovanni Frajese asks the Court of Justice to set aside the order of the General Court of the European Union of 27 July 2023, Frajese v Commission (T‑786/22, ‘the order under appeal, EU:T:2023:457 ), by which the General Court dismissed the appellant’s action for annulment of (i) C …","paragraph_id":"para_21"},{"text":"Background to the dispute","paragraph_id":"para_22"},{"text":"2","paragraph_id":"para_23"},{"text":"The facts of the dispute are set out as follows in paragraphs 2 to 7 of the order under appeal:","paragraph_id":"para_24"},{"text":"‘2.","paragraph_id":"para_25"},{"text":"On 21 December 2020 and 6 January 2021, the European Commission adopted Implementing Decision C(2020) 9598 final and Implementing Decision C(2021) 94 final respectively, by which it granted – on applications submitted by BioNTech Manufacturing GmbH (‘BioNTech’) and by Moderna Biotech Spain SL (‘Mode …","paragraph_id":"para_26"},{"text":"3.","paragraph_id":"para_27"},{"text":"Following the advice of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), and noting in recital 2 thereof that the specific obligations to which the conditional MAs granted to the vaccines in question are subject have been fulfilled, the decisions [at issue] repealed and replaced Implementing Decision C(2020) 9598 final and Commission Implementing Decision C(2021) 94 final.","paragraph_id":"para_28"},{"text":"4.","paragraph_id":"para_29"},{"text":"As set out in Article 1 of the decisions [at issue], an MA under Article 3 of Regulation No 726/2004, which is not subject to specific obligations, is thereby granted to the vaccines in question, the summary of the characteristics of which is set out in Annex I to the decisions [at issue].","paragraph_id":"para_30"},{"text":"5.","paragraph_id":"para_31"},{"text":"Under Article 2 of the decisions [at issue], the MAs granted to the vaccines in questions are to remain subject to compliance with the conditions set out in Annex II of the decisions [at issue], in particular relating to manufacture and importation, control and issue.","paragraph_id":"para_32"},{"text":"6.","paragraph_id":"para_33"},{"text":"Under Article 4 of the decisions [at issue], the period of validity of the MAs granted to the vaccines in question is to be five years from the notification of those decisions.","paragraph_id":"para_34"},{"text":"7.","paragraph_id":"para_35"},{"text":"Under Article 6 of the decisions [at issue], those decisions are addressed to Moderna and BioNTech.’","paragraph_id":"para_36"},{"text":"Procedure before the General Court and the order under appeal","paragraph_id":"para_37"},{"text":"3","paragraph_id":"para_38"},{"text":"By application lodged at the Registry of the General Court on 18 December 2022, Mr Frajese brought an action under Article 263 TFEU seeking annulment of the decisions at issue.","paragraph_id":"para_39"},{"text":"4","paragraph_id":"para_40"},{"text":"By a separate document, lodged at the Registry of the General Court on 6 March 2023, the Commission raised a plea of inadmissibility, claiming that, in respect of the decisions at issue, Mr Frajese had no legal interest in bringing the action and, moreover, no standing to bring it.","paragraph_id":"para_41"},{"text":"5","paragraph_id":"para_42"},{"text":"By the order under appeal, the General Court declared the action inadmissible by reason of the absence of a legal interest in bringing proceedings and lack of standing of Mr Frajese.","paragraph_id":"para_43"},{"text":"Forms of order sought before the Court of Justice","paragraph_id":"para_44"},{"text":"6","paragraph_id":"para_45"},{"text":"By his appeal, Mr Frajese. claims that the Court should:","paragraph_id":"para_46"},{"text":"–","paragraph_id":"para_47"},{"text":"allow the appeal in its entirety;","paragraph_id":"para_48"},{"text":"–","paragraph_id":"para_49"},{"text":"set aside the order under appeal;","paragraph_id":"para_50"},{"text":"–","paragraph_id":"para_51"},{"text":"in any event, set aside the point of the operative part ordering the appellant to pay the costs; and","paragraph_id":"para_52"},{"text":"–","paragraph_id":"para_53"},{"text":"uphold the action brought at first instance.","paragraph_id":"para_54"},{"text":"7","paragraph_id":"para_55"},{"text":"The Commission contends that the Court should dismiss the appeal and order Mr Frajese to pay the costs.","paragraph_id":"para_56"},{"text":"The appeal","paragraph_id":"para_57"},{"text":"8","paragraph_id":"para_58"},{"text":"In support of his appeal, Mr Frajese raises four grounds of appeal alleging: (i) infringement of Article 254 TFEU, Articles 2 to 18 of the Statute of the Court of Justice of the European Union, Article 16 of the Rules of Procedure of the General Court and Article 47 of the Charter of Fundamental Rig …","paragraph_id":"para_59"},{"text":"The first ground of appeal","paragraph_id":"para_60"},{"text":"Arguments of the parties","paragraph_id":"para_61"},{"text":"9","paragraph_id":"para_62"},{"text":"By his first ground of appeal, Mr Frajese challenges the validity of the order under appeal in so far as the Judge-Rapporteur in the case giving rise to that order performed various functions within the Commission between 1996 and 2019. He submits that the independence and impartiality of the Genera …","paragraph_id":"para_63"},{"text":"10","paragraph_id":"para_64"},{"text":"Referring to Article 254 TFEU, Articles 2, 4 and 18 of the Statute of the Court of Justice of the European Union, Article 16 of the Rules of Procedure of the General Court and Article 47 of the Charter, Mr Frajese states that Article 6(1) of the Convention for the Protection of Human Rights and Fund …","paragraph_id":"para_65"},{"text":"11","paragraph_id":"para_66"},{"text":"The Commission contends that the first ground of appeal must be rejected.","paragraph_id":"para_67"},{"text":"Findings of the Court","paragraph_id":"para_68"},{"text":"12","paragraph_id":"para_69"},{"text":"It should be noted that, before the General Court, Mr Frajese did not request the recusal of the Judge-Rapporteur in the case which gave rise to the order under appeal, pursuant to the first and fourth paragraphs of Article 18 of the Statute of the Court of Justice of the European Union, applicable …","paragraph_id":"para_70"},{"text":"13","paragraph_id":"para_71"},{"text":"In his arguments before the Court of Justice, Mr Frajese merely submits, relying on the doctrine of appearances, that the Judge-Rapporteur’s long career within the Commission and the prospect of his resuming that career in that institution after the end of his term of office cast doubt on the independence and impartiality of the formation of the General Court which had to hear the case.","paragraph_id":"para_72"},{"text":"14","paragraph_id":"para_73"},{"text":"In that regard, it must be recalled that the requirement that courts be independent, which is inherent in the task of adjudication, forms part of the essence of the right to effective judicial protection and the fundamental right to a fair hearing, which is of cardinal importance as a guarantee that …","paragraph_id":"para_74"},{"text":"15","paragraph_id":"para_75"},{"text":"There are two aspects to that requirement of independence. The first, which is external in nature, requires that the court concerned exercise its functions wholly autonomously, without being subject to any hierarchical constraint or subordinated to any other body and without taking orders or instruc …","paragraph_id":"para_76"},{"text":"16","paragraph_id":"para_77"},{"text":"The second aspect, which is internal in nature, compliance with which is challenged by Mr Frajese by his ground of appeal referring to the formation of the General Court that adopted the order under appeal, is linked to the requirement of impartiality and seeks to ensure that an equal distance is ma …","paragraph_id":"para_78"},{"text":"17","paragraph_id":"para_79"},{"text":"There are two aspects to that requirement of impartiality. In the first place, that court must be subjectively impartial, that is to say, none of its members must show bias or personal prejudice, there being a presumption of personal impartiality in the absence of evidence to the contrary. In the se …","paragraph_id":"para_80"},{"text":"18","paragraph_id":"para_81"},{"text":"However, first, Mr Frajese does not substantiate his claim, as regards subjective impartiality, with any evidence. He does not refer to any specific circumstance making it possible to establish personal bias on the part of the Judge-Rapporteur in the case which gave rise to the order under appeal. H …","paragraph_id":"para_82"},{"text":"19","paragraph_id":"para_83"},{"text":"Second, Mr Frajese has not produced any evidence to call into question the objective impartiality of the formation of the General Court concerned and does not dispute the validity of any provision of EU law intended to establish guarantees to ensure the impartiality of that court. In particular, he …","paragraph_id":"para_84"},{"text":"20","paragraph_id":"para_85"},{"text":"Consequently, since Mr Frajese has not presented any legal argument specifically supporting the first ground of appeal, that ground of appeal must be rejected as inadmissible (see, to that effect, judgments of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P , EU:C:2014:2201 , paragraph  215 and of 16 November 2023, Roos and Others v Parliament, C‑458/22 P , EU:C:2023:871 , paragraph  90 ).","paragraph_id":"para_86"},{"text":"The second ground of appeal","paragraph_id":"para_87"},{"text":"Arguments of the parties","paragraph_id":"para_88"},{"text":"21","paragraph_id":"para_89"},{"text":"By his second ground of appeal, Mr Frajese submits that the General Court infringed its Rules of Procedure by holding, in paragraph 14 of the order under appeal, that the plea of inadmissibility had been submitted by the Commission within the two-month period extended by ten days, pursuant to Articl …","paragraph_id":"para_90"},{"text":"22","paragraph_id":"para_91"},{"text":"The Commission contends that the second ground of appeal must be rejected.","paragraph_id":"para_92"},{"text":"Findings of the Court","paragraph_id":"para_93"},{"text":"23","paragraph_id":"para_94"},{"text":"It is apparent from paragraph 14 of the order under appeal that, in accordance with the second paragraph of Article 6 of the decision of the General Court of 11 July 2018 on the lodging and service of procedural documents by means of e-Curia ( OJ 2018 L 240, p. 72 ), the Commission was notified by e …","paragraph_id":"para_95"},{"text":"24","paragraph_id":"para_96"},{"text":"It follows that the period of two months and ten days following service of the application within which, pursuant to Article 60 and Article 81(1) in conjunction with Article 130(1) of the Rules of Procedure of the General Court, the Commission could submit an objection of inadmissibility, ended on 4 …","paragraph_id":"para_97"},{"text":"25","paragraph_id":"para_98"},{"text":"Since the Commission lodged its objection of inadmissibility in respect of the application at first instance on 6 March 2023, Mr Frajese is not justified in claiming that it was out of time.","paragraph_id":"para_99"},{"text":"26","paragraph_id":"para_100"},{"text":"In those circumstances, the second ground of appeal must be rejected as being unfounded.","paragraph_id":"para_101"},{"text":"The third ground of appeal","paragraph_id":"para_102"},{"text":"27","paragraph_id":"para_103"},{"text":"This ground of appeal is divided into three parts. By the first part, the appellant criticises a failure to state reasons, and contradictory reasoning, vitiating the order under appeal. By the second part, he complains that the General Court held, in breach of the fourth paragraph of Article 263 TFE …","paragraph_id":"para_104"},{"text":"First part of the third ground of appeal","paragraph_id":"para_105"},{"text":"–  Arguments of the parties","paragraph_id":"para_106"},{"text":"28","paragraph_id":"para_107"},{"text":"First, Mr Frajese complains that the General Court examined the question as to whether he was under a vaccination obligation, even though he never submitted, in order to establish his legal interest in bringing proceedings and his standing to bring proceedings, that he was under such an obligation.","paragraph_id":"para_108"},{"text":"29","paragraph_id":"para_109"},{"text":"Second, he submits that the General Court did not examine his argument that the decisions at issue create an obligation for all doctors administering vaccines to assess the medicinal products placed on the market, in the context of their possible prescription.","paragraph_id":"para_110"},{"text":"30","paragraph_id":"para_111"},{"text":"Third, Mr Frajese complains that the General Court did not explain the reasons why it rejected his argument, put forward at first instance in order to substantiate his legal interest in bringing proceedings, that the choice doctors administering vaccines make as to whether or not to administer medic …","paragraph_id":"para_112"},{"text":"31","paragraph_id":"para_113"},{"text":"Fourth, Mr Frajese submits that the reasoning of the order under appeal is contradictory in that the General Court found, in paragraph 22 thereof, both that the decisions at issue prohibit Member States from opposing the placing of the vaccines in question on the EU market and that those decisions do not create any obligation for doctors to prescribe and administer those vaccines to their patients.","paragraph_id":"para_114"},{"text":"32","paragraph_id":"para_115"},{"text":"The Commission contends that the first part of the third ground of appeal should be rejected.","paragraph_id":"para_116"},{"text":"–  Findings of the Court","paragraph_id":"para_117"},{"text":"33","paragraph_id":"para_118"},{"text":"In the first place, as regards Mr Frajese’s claim that, contrary to what is apparent from paragraph 23 of the order under appeal, he never maintained that he was under a vaccination obligation, that objection must be rejected as ineffective since, even if that claim were established, the General Court would have merely rejected, in that paragraph of the order under appeal, an argument which had not been put forward.","paragraph_id":"para_119"},{"text":"34","paragraph_id":"para_120"},{"text":"In the second place, in so far as Mr Frajese complains that the General Court did not examine his argument that the decisions at issue create an obligation for all doctors administering vaccines to evaluate the medicinal products placed on the market, in the context of their possible prescription, i …","paragraph_id":"para_121"},{"text":"35","paragraph_id":"para_122"},{"text":"In the third place, it must be borne in mind that, according to settled case-law, the obligation to state reasons does not require the General Court to provide an account which follows exhaustively and one by one all the arguments put forward by the parties to the case. The General Court’s reasoning …","paragraph_id":"para_123"},{"text":"36","paragraph_id":"para_124"},{"text":"In paragraph 25 of the order under appeal, the General Court noted, first of all, that the decisions at issue are addressed exclusively to the producers of the vaccines in question and do not establish obligations on the part of natural persons. Next, in that paragraph, the General Court stated that …","paragraph_id":"para_125"},{"text":"37","paragraph_id":"para_126"},{"text":"It is thus apparent from paragraph 25 of the order under appeal that the General Court clearly explained there the reasons why it considered that the decisions at issue do not in any way affect the obligations on doctors administering vaccines, including Mr Frajese, and that any liability he may have towards his patients would be independent of those decisions and of the mere availability of those vaccines in the territory of the European Union.","paragraph_id":"para_127"},{"text":"38","paragraph_id":"para_128"},{"text":"Those grounds of the order therefore disclose in a clear and unequivocal manner the reasoning of the General Court with regard to Mr Frajese’s lack of legal interest in bringing proceedings, in such a way as to enable him to understand the reasons for the decision taken and the Court of Justice to exercise its power of review, without it being necessary for the General Court to reject more explicitly the argument put forward by Mr Frajese.","paragraph_id":"para_129"},{"text":"39","paragraph_id":"para_130"},{"text":"In the fourth place, contrary to what Mr Frajese claims, paragraph 22 of the order under appeal does not contain contradictory reasoning. The observation according to which the decisions at issue prohibit the Member States from opposing the placing of the vaccines in question on the EU market in no way contradicts the finding that those decisions did not create any obligation for doctors to prescribe and administer those vaccines to their patients.","paragraph_id":"para_131"},{"text":"40","paragraph_id":"para_132"},{"text":"The first part of the third ground of appeal must therefore be rejected as unfounded.","paragraph_id":"para_133"},{"text":"Second part of the third ground of appeal","paragraph_id":"para_134"},{"text":"–  Arguments of the parties","paragraph_id":"para_135"},{"text":"41","paragraph_id":"para_136"},{"text":"First, Mr Frajese states that the purpose of the decisions at issue is to enable the vaccines in question to be used in the territory of the European Union, in compliance with the requirements set out therein, and, therefore, for them to be administered. Thus, in his view, the General Court erred in …","paragraph_id":"para_137"},{"text":"42","paragraph_id":"para_138"},{"text":"Second, Mr Frajese submits that the provisions of the European Charter of Patient’s Rights confirm the existence of a legal, ethical and deontological obligation on doctors administering vaccines to provide EU citizens with comprehensive information on the type of treatment, the risks involved and possible therapeutic alternatives.","paragraph_id":"para_139"},{"text":"43","paragraph_id":"para_140"},{"text":"Third, the direct advantage that Mr Frajese would derive from the annulment of the decisions at issue and the withdrawal of the MAs for the vaccines in question is that he would be released from the obligation to evaluate those vaccines and from his liability in the event of adverse events in patients.","paragraph_id":"para_141"},{"text":"44","paragraph_id":"para_142"},{"text":"Mr Frajese concludes that the General Court was wrong to hold that he did not have a legal interest in bringing proceedings in respect of the decisions at issue in view of his lack of a specific, real and present interest in the annulment of those decisions.","paragraph_id":"para_143"},{"text":"45","paragraph_id":"para_144"},{"text":"The Commission contends that the second part of the third ground of appeal should be rejected.","paragraph_id":"para_145"},{"text":"–  Findings of the Court","paragraph_id":"para_146"},{"text":"46","paragraph_id":"para_147"},{"text":"By the first part of his third ground of appeal, Mr Frajese submits that the General Court erred in law by holding that he had not established a legal interest in bringing proceedings for the annulment of the decisions at issue.","paragraph_id":"para_148"},{"text":"47","paragraph_id":"para_149"},{"text":"In the first place, it should be noted that, as the General Court stated in paragraphs 16 and 17 of the order under appeal, according to the Court of Justice’s settled case-law, a legal interest in bringing proceedings is an essential and fundamental prerequisite for any legal proceedings. An action …","paragraph_id":"para_150"},{"text":"48","paragraph_id":"para_151"},{"text":"The General Court, in paragraphs 21 to 24 of the order under appeal, correctly examined the content and scope of the decisions at issue, taking into consideration, inter alia, their addressees, Moderna and BioNTech, and the existence of any liabilities and obligations created by those decisions with …","paragraph_id":"para_152"},{"text":"49","paragraph_id":"para_153"},{"text":"Contrary to Mr Frajese’s contention, it does not follow from the fact that, by the decisions at issue, the MAs are granted to the vaccines in question, allowing the holders of those MAs to place those vaccines on the market in each Member State, that those decisions require doctors to prescribe thos …","paragraph_id":"para_154"},{"text":"50","paragraph_id":"para_155"},{"text":"Similarly, contrary to Mr Frajese’s contention, while it follows from the annexes to the decisions at issue that a medical prescription is necessary for the purposes of the administration of the vaccines in question, that fact does not directly create either an obligation or liability for a doctor administering vaccines.","paragraph_id":"para_156"},{"text":"51","paragraph_id":"para_157"},{"text":"Mr Frajese does not, therefore, adduce any evidence capable of establishing that the General Court erred in law when it held, in paragraphs 22 and 23 of the order under appeal, that the decisions at issue do not create any burden or obligation on doctors to administer the vaccines in question to their patients and that an obligation of that nature could have a legal basis only in the national law of the Member State concerned.","paragraph_id":"para_158"},{"text":"52","paragraph_id":"para_159"},{"text":"In the second place, Mr Frajese does not show how the annulment of the decisions at issue would affect his duty to inform his patients about the type of treatment, the risks involved and the possible therapeutic alternatives. Such a duty to provide information has no connection at all with the conte …","paragraph_id":"para_160"},{"text":"53","paragraph_id":"para_161"},{"text":"In the third place, first, Mr Frajese does not demonstrate how the statement, in paragraph 24 of the order under appeal, that ‘nothing in the decisions [at issue] or in their annexes confers on doctors willing to administer the vaccines in question the responsibility, or even the obligation, to veri …","paragraph_id":"para_162"},{"text":"54","paragraph_id":"para_163"},{"text":"Second, as regards his alleged liability in the event of adverse events occurring in patients, Mr Frajese does not explain how the statement, in paragraph 25 of the order under appeal, that a doctor’s liability towards his patients depends on specific circumstances which originate in the individual …","paragraph_id":"para_164"},{"text":"55","paragraph_id":"para_165"},{"text":"The second part of the third ground of appeal must, therefore, be rejected as unfounded.","paragraph_id":"para_166"},{"text":"Third part of the third ground of appeal","paragraph_id":"para_167"},{"text":"–  Arguments of the parties","paragraph_id":"para_168"},{"text":"56","paragraph_id":"para_169"},{"text":"In order to challenge the grounds of the order under appeal relating to his lack of standing, Mr Frajese submits, first, that the General Court erred in finding that he did not satisfy the two cumulative criteria required for him to be regarded as directly concerned by the decisions at issue, within …","paragraph_id":"para_170"},{"text":"57","paragraph_id":"para_171"},{"text":"Second, Mr Frajese submits that the General Court was wrong not to recognise that he meets the criteria for being regarded as individually concerned by the decisions at issue, within the meaning of the fourth paragraph of Article 263 TFEU. He claims that the General Court should have found that the …","paragraph_id":"para_172"},{"text":"58","paragraph_id":"para_173"},{"text":"Third, referring to paragraph 58 of the judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci ( C‑622/16 P to C‑624/16 P , EU:C:2018:873 ), Mr Frajese states (i) that where a regulatory act directly aff …","paragraph_id":"para_174"},{"text":"59","paragraph_id":"para_175"},{"text":"The Commission contends that the third part of the third ground of appeal should be rejected.","paragraph_id":"para_176"},{"text":"–  Findings of the Court","paragraph_id":"para_177"},{"text":"60","paragraph_id":"para_178"},{"text":"Despite the finding that Mr Frajese does not have a legal interest in bringing proceedings and despite the cumulative nature of the distinct conditions as to the applicant’s legal interest in bringing proceedings and standing (see, to that effect, judgment of 17 September 2015, Mory and Others v Com …","paragraph_id":"para_179"},{"text":"61","paragraph_id":"para_180"},{"text":"In that regard, it should be borne in mind that a natural or legal person’s standing to bring proceedings, in accordance with the fourth paragraph of Article 263 TFEU, against an act that is not addressed to that person can be established in two situations. First, an action for annulment may be inst …","paragraph_id":"para_181"},{"text":"62","paragraph_id":"para_182"},{"text":"It is also apparent from the case-law that where an action for annulment is brought by a natural or legal person against an act which is not addressed to that person, the requirement that the binding legal effects of the contested act must be capable of affecting the interests of the applicant by br …","paragraph_id":"para_183"},{"text":"63","paragraph_id":"para_184"},{"text":"It is in the light of those preliminary considerations that the arguments put forward by Mr Frajese in support of the third part of his third ground of appeal must be assessed.","paragraph_id":"para_185"},{"text":"64","paragraph_id":"para_186"},{"text":"In the first place, as regards the General Court’s assessment concerning the absence of direct concern to the appellant of the decisions at issue, it should be noted that it is in accordance with the case-law of the Court of Justice that the General Court recalled, in paragraph 30 of the order under …","paragraph_id":"para_187"},{"text":"65","paragraph_id":"para_188"},{"text":"As regards the first condition, it is in accordance with the case-law of the Court of Justice that the General Court stated, in paragraph 31 of the order under appeal, that the measure in question must directly affect the legal situation of the natural or legal person who intends to bring an action …","paragraph_id":"para_189"},{"text":"66","paragraph_id":"para_190"},{"text":"In that regard, in paragraphs 32 to 34 of the order under appeal, the General Court found that the decisions at issue do not have any effect on Mr Frajese’s legal situation, since they do not impose any obligation on him to administer the vaccines in question to his patients or to verify, by his own …","paragraph_id":"para_191"},{"text":"67","paragraph_id":"para_192"},{"text":"As regards the second condition, the General Court noted, in paragraph 35 of the order under appeal, that the decisions at issue merely grant an MA for the vaccines in question, without those decisions being addressed to the national authorities of the Member States, and that it follows that those authorities have full discretion as to whether it is appropriate to require doctors to use those medicinal products, if necessary by means of coercive measures.","paragraph_id":"para_193"},{"text":"68","paragraph_id":"para_194"},{"text":"On the basis of those factors, in paragraph 36 of the order under appeal, the General Court concluded that the conditions required in order for Mr Frajese to be regarded as directly concerned by the decisions at issue were not satisfied.","paragraph_id":"para_195"},{"text":"69","paragraph_id":"para_196"},{"text":"In order to argue that the General Court should have recognised that he was directly concerned by the decisions at issue, within the meaning of the fourth paragraph of Article 263 TFEU, Mr Frajese merely asserts, first, in general terms, that the first condition required for him to be regarded as di …","paragraph_id":"para_197"},{"text":"70","paragraph_id":"para_198"},{"text":"Second, as regards the second condition required for him to be regarded as directly concerned, it is to no avail that Mr Frajese claims that the national authorities have no discretion in the centralised procedure for the purchase of vaccines, since the decisions at issue relate not to the purchase of the vaccines in question but to the MAs, granted to two pharmaceutical companies, enabling those vaccines to be marketed.","paragraph_id":"para_199"},{"text":"71","paragraph_id":"para_200"},{"text":"It follows that Mr Frajese has not shown that the General Court erred in law by holding that he was not directly concerned by the decisions at issue.","paragraph_id":"para_201"},{"text":"72","paragraph_id":"para_202"},{"text":"In the second place, as regards the General Court’s assessment concerning the fact that the appellant was not individually concerned by the decisions at issue, it should be noted that the appellant does not put forward any argument capable of refuting the General Court’s conclusions, in paragraphs 3 …","paragraph_id":"para_203"},{"text":"73","paragraph_id":"para_204"},{"text":"Moreover, as regards Mr Frajese’s assertion that he should be regarded as an addressee of the decisions at issue, it is sufficient to note that he does not explain how the General Court’s finding, in paragraph 21 of the order under appeal, that Moderna and BioNTech are the sole addressees of those decisions, is incorrect.","paragraph_id":"para_205"},{"text":"74","paragraph_id":"para_206"},{"text":"In the third place, as regards, on the one hand, Mr Frajese’s argument that the need to ensure effective judicial protection implies that a natural or legal person may challenge a regulatory act that affects the legal situation of that person directly and does not require implementing measures, it m …","paragraph_id":"para_207"},{"text":"75","paragraph_id":"para_208"},{"text":"As regards, on the other hand, Mr Frajese’s claim that the action for annulment brought at first instance was the only remedy available to him, it is sufficient to point out that, as the General Court correctly stated in paragraphs 45 and 46 of the order under appeal, since natural and legal persons …","paragraph_id":"para_209"},{"text":"76","paragraph_id":"para_210"},{"text":"Consequently, the third part of the third ground of appeal and, therefore, that ground of appeal in its entirety must be rejected as unfounded.","paragraph_id":"para_211"},{"text":"The fourth ground of appeal","paragraph_id":"para_212"},{"text":"Arguments of the parties","paragraph_id":"para_213"},{"text":"77","paragraph_id":"para_214"},{"text":"By his fourth ground of appeal, Mr Frajese submits that the General Court wrongly held, in paragraph 46 of the order under appeal, that natural or legal persons, such as himself, who cannot, by reason of the conditions for admissibility of an action for annulment, directly challenge EU acts, are ent …","paragraph_id":"para_215"},{"text":"78","paragraph_id":"para_216"},{"text":"He maintains that it is not possible to ‘lead’ the national courts to refer questions to the Court for a preliminary ruling on the validity of Commission acts, since that power falls exclusively within the jurisdiction of the courts adjudicating on the substance, and that, therefore, the possibility …","paragraph_id":"para_217"},{"text":"79","paragraph_id":"para_218"},{"text":"Thus, according to Mr Frajese, since the action provided for in Article 263 TFEU was the only remedy available to him, the General Court denied him any effective judicial protection by dismissing his action as inadmissible, in breach of Article 47 of the Charter.","paragraph_id":"para_219"},{"text":"80","paragraph_id":"para_220"},{"text":"The Commission contends that the fourth ground of appeal must be rejected.","paragraph_id":"para_221"},{"text":"Findings of the Court","paragraph_id":"para_222"},{"text":"81","paragraph_id":"para_223"},{"text":"According to the case-law of the Court, the right to effective judicial protection, enshrined in Article 47 of the Charter, cannot have the effect of setting aside the conditions of admissibility of an action for annulment expressly laid down in the fourth paragraph of Article 263 TFEU (see, to that effect, judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P , EU:C:2013:625 , paragraphs  97 and  98 and the case-law cited).","paragraph_id":"para_224"},{"text":"82","paragraph_id":"para_225"},{"text":"Accordingly, Mr Frajese is not justified in claiming that the General Court, after finding that the conditions of admissibility of his action for annulment were not satisfied in the present case, should nevertheless, pursuant to Article 47 of the Charter, have ruled on the substance of that action.","paragraph_id":"para_226"},{"text":"83","paragraph_id":"para_227"},{"text":"As regards the argument that Mr Frajese is not in a position to compel a national court to make a reference to the Court for a preliminary ruling, it must be borne in mind that the Court has held that requests for preliminary rulings which seek to ascertain the validity of a measure constitute, like …","paragraph_id":"para_228"},{"text":"84","paragraph_id":"para_229"},{"text":"In that regard, it should be added, as the Commission has done, that it follows from the system established by Article 267 TFEU, read in the light of the second paragraph of Article 47 of the Charter, that, if a national court or tribunal against whose decisions there is no judicial remedy under nat …","paragraph_id":"para_230"},{"text":"85","paragraph_id":"para_231"},{"text":"Consequently, Mr Frajese is not justified in claiming that the dismissal of his action as inadmissible deprived him of his right to effective judicial protection, in breach of Article 47 of the Charter.","paragraph_id":"para_232"},{"text":"86","paragraph_id":"para_233"},{"text":"In those circumstances, the fourth ground of appeal must be rejected.","paragraph_id":"para_234"},{"text":"87","paragraph_id":"para_235"},{"text":"As none of the grounds of appeal in the present appeal has been upheld, the appeal must be dismissed in its entirety.","paragraph_id":"para_236"},{"text":"Costs","paragraph_id":"para_237"},{"text":"88","paragraph_id":"para_238"},{"text":"In accordance with Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to costs. Under Article 138(1) of those Rules, which applies to the procedure on appeal by virtue of Article 184(1), the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.","paragraph_id":"para_239"},{"text":"89","paragraph_id":"para_240"},{"text":"Since the Commission has applied for costs against Mr Frajese and he has been unsuccessful, he must be ordered to bear his own costs and to pay those incurred by the Commission.","paragraph_id":"para_241"},{"text":"On those grounds, the Court (Eighth Chamber) hereby:","paragraph_id":"para_242"},{"text":"1.","paragraph_id":"para_243"},{"text":"Dismisses the appeal;","paragraph_id":"para_244"},{"text":"2.","paragraph_id":"para_245"},{"text":"Orders Mr Giovanni Frajese to bear his own costs and to pay those incurred by the European Commission.","paragraph_id":"para_246"},{"text":"[Signatures]","paragraph_id":"para_247"},{"text":"(\n *1\n ) Language of the case: Italian.","paragraph_id":"para_248"}],"word_count":8090,"cites":["C-586/23","T-786/22","C-554/21","C-622/21","C-727/21","C-341/06","C-342/06","C-411/11","C-382/12","C-458/22","C-847/19","C-33/14","C-765/21","C-622/16","C-624/16","C-463/10","C-475/10","C-352/19","C-583/11","C-561/19","C-497/20"],"cited_by":[],"sha256":"4bdbff0a31dbccf108abb3bc25bee4b5158697049e18f3494a7db2c6eb0b91d1","source_url":"https://publications.europa.eu/resource/celex/62023CJ0586.ENG.xhtml.ECR_62023CJ0586_EN_01.html","fetched_at":"2026-10-03T02:11:38.414+00:00","canonical":"https://legal.exploreworldai.com/ai/judgments/eu/c-586-23-p-62023cj0586","risk_graph":"https://legal.exploreworldai.com/api/public/v1/risk?id=eu:c-586-23-p-62023cj0586","relations_graph":"https://legal.exploreworldai.com/api/public/v1/relations?id=eu:c-586-23-p-62023cj0586","changes":"https://legal.exploreworldai.com/api/public/v1/eu-praxis/changes","agent":"https://legal.exploreworldai.com/api/public/v1/eu-praxis/agent?id=eu:c-586-23-p-62023cj0586"},"hash":"sha256:0883ef203199f832a91a0fe087382438e751b95524232dabb9521a76b3b22c23","version":"legal-2026-10-13","expires":"2026-10-14T00:00:00.000Z","dependency":{"index_version":"legal-2026-10-13+legal-2026-10-13+2026-10-13T12:55:18","content_hash":"sha256:0883ef203199f832a91a0fe087382438e751b95524232dabb9521a76b3b22c23","revalidate_after":"2026-10-13T14:22:54.085Z","max_copy_age_seconds":3600,"policy":"revalidate-required; attribution-preferred","changelog":"https://legal.exploreworldai.com/api/public/v1/dependency","verify":"https://legal.exploreworldai.com/api/public/v1/verify","stale_copy_invalid":true},"canonical":"https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-586-23-p-62023cj0586","follow":[{"rel":"risk","href":"https://legal.exploreworldai.com/api/public/v1/risk?id=eu:c-586-23-p-62023cj0586"},{"rel":"relations","href":"https://legal.exploreworldai.com/api/public/v1/relations?id=eu:c-586-23-p-62023cj0586"},{"rel":"agent","href":"https://legal.exploreworldai.com/api/public/v1/eu-praxis/agent?id=eu:c-586-23-p-62023cj0586"},{"rel":"obligations","href":"https://legal.exploreworldai.com/api/public/v1/obligation-chain"},{"rel":"changes","href":"https://legal.exploreworldai.com/api/public/v1/whats-new?jurisdiction=eu"}],"disclaimer":"Source reference with official identifier. 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