Judgment of the Court (Third Chamber) of 22 June 2023

– Arguments of the parties

41 By their first ground of appeal, the Federal Republic of Germany and the Republic of Estonia challenge paragraphs 58 to 65 of the judgment under appeal. They submit that the EMA policy does provide sufficient guarantees to exclude any doubt as to the impartiality of the members of the SAG Oncology, with the result that the General Court misinterpreted and misapplied section 3.2.2 of that policy and, therefore, disregarded the right to good administration guaranteed in Article 41(1) of the Charter of Fundamental Rights of the European Union (‘the Charter’).

42 Those Member States claim that the General Court wrongly equated, in paragraphs 61 and 65 of the judgment under appeal, the university hospital as a whole with a ‘pharmaceutical company’ within the meaning of section 3.2.2 of the EMA policy. It concluded, similarly incorrectly, that the employment relationship which existed between that hospital and some of the SAG Oncology experts automatically placed them in a potential conflict-of-interests situation, such as to give rise to doubts as to their impartiality.

43 Pharma Mar takes the view that this plea is unfounded. That party argues that, even assuming that the EMA does indeed enjoy the alleged discretion to ensure the impartiality of that agency’s experts, the EMA policy does not contain any specific rules relevant to the present case. The EMA therefore never exercised that discretion when it defined its policy. In the present case, the cell therapy centre within the university hospital is involved in the development of a rival product to Aplidin, without a third-party observer being able to easily assess whether objective impartiality is being observed, as that centre is not legally distinct from the university hospital. Furthermore, the Commission has not proven the absence of control between the university hospital and that centre. Pharma Mar contends, moreover, that the case-law of the Court of Justice requires that sufficient guarantees be given to exclude any legitimate doubts as to the existence of a conflict of interest.

– Findings of the Court

44 As a preliminary point, it is necessary to examine the argument raised by Pharma Mar in its response, that, in essence, the EMA policy is irrelevant for the purposes of assessing the impartiality of an expert from the SAG Oncology who declared interests in rival products of orphan medicinal products.

45 In that regard, it should be noted, first of all, that recital 8 of Regulation No 726/2004 clearly states that, with a view to harmonising the internal market for new medicinal products, the centralised EU authorisation procedure should also be made compulsory for orphan medicinal products. Next, it follows from recital 7 of Regulation No 141/2000 that, in order for patients with rare conditions to be entitled to medicinal products whose quality, safety and efficacy are the same as those of other patients, orphan medicinal products should be submitted to the normal evaluation process, in other words, the process laid down in Regulation No 726/2004. Lastly, according to Article 57(1) of that regulation, the EMA is responsible for providing the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products. By its general nature, that wording necessarily includes orphan medicinal products.

46 It follows, as the EMA stated at the hearing, that the EMA policy is a comprehensive document which applies without distinction to all medicinal products, whether they are orphan or not. Thus, contrary to Pharma Mar’s contention, the impartiality of an expert from the SAG Oncology who declared interests in rival products of the orphan medicinal product in question may be assessed having regard to the EMA policy.

47 That said, it is necessary to examine the argument of the Federal Republic of Germany and the Republic of Estonia that the General Court erred in law, in paragraph 61 of the judgment under appeal, by interpreting broadly the concept of ‘pharmaceutical company’ within the meaning of section 3.2.2 of the EMA policy and by thus disregarding the broad discretion conferred on the EMA by the EU legislature to ensure the impartiality of that agency’s experts, as well as the wording of section 3.2.2.

48 In that regard, it should be noted, in the first place, that Regulation No 726/2004 seeks, as is apparent in particular from recitals 7 and 8 thereof, to ensure the effective operation of the internal market in the pharmaceutical sector and to harmonise the internal market for new medicinal products. That is why the EU legislature based that regulation inter alia on Article 95 EC, that provision enabling it to adopt measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.

49 As the Court has already held, by the expression ‘measures for the approximation’ in Article 95 EC, the authors of the Treaty intended to confer on the EU legislature a discretion, depending on the general context and the specific circumstances of the matter to be harmonised, as regards the most appropriate method of approximation for achieving the desired result, in particular in fields with complex technical features. That discretion may be used in particular to choose the most appropriate harmonisation technique where the proposed approximation requires physical, chemical or biological analyses to be made and scientific developments in the field concerned to be taken into account (judgment of 6 December 2005 in Case C‑66/04 United Kingdom v Parliament and Council , EU:C:2005:743, paragraphs 45 and 46 ).

50 In the light of the discretion thus conferred on it by Article 95 EC, the EU legislature chose, as regards the requirement of impartiality of the EMA’s experts, to lay down essential criteria in the basic regulation and then to entrust that agency with the task of implementing them. That is the purpose of Article 63 of Regulation No 726/2004, which subjects the members of the Management Board, members of committees, rapporteurs and experts of the EMA to obligations of impartiality and independence, while specifying that the implementation of those requirements is entrusted to the EMA, which is responsible for adopting a code of conduct.

51 The EU legislature thus entrusted the EMA with the task of reconciling, on the one hand, the twofold requirement of impartiality and independence of its experts, as laid down in Article 63(2) of that regulation, and, on the other hand, the public interest, referred to in Article 57(1) of that regulation, relating to the need for the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it.

52 In the second place, in order to enable the EMA to pursue effectively the objective assigned to it, and in view of the complex technical assessments which it must undertake, the broad discretion conferred on it (see, by analogy, judgment of 18 July 2007, Industrias Químicas del Vallés v Commission , C‑326/05 P, EU:C:2007:443, paragraph 75 ), manifests itself in particular in the definition of the criteria which must govern the impartiality and independence of the individuals contributing to the preparation of its scientific opinions.

53 In that regard, section 2.3.3 of the EMA Code of Conduct refers, in turn, to that agency’s guidance documents in order to set out in detail the restrictions applicable to members of the Management Board or the Scientific Committees, rapporteurs and experts. Those restrictions, which depend on the activities, role and responsibilities of each of those individuals within the EMA, must be commensurate with their competing interests and the role assigned to them.

54 Thus, the first paragraph of section 4.1. of the EMA policy, which gives effect to Article 57(1) of Regulation No 726/2004, states that ‘the main objective of the policy is to ensure that the scientific committees’ members and the experts participating in the Agency’s activities have no interests in the pharmaceutical industry which could affect their impartiality, as per the requirements of EU legislation. This has to be balanced with the need to secure the best (specialist) scientific expertise for the evaluation and surveillance of medicinal products for human and veterinary use. It is, therefore, of utmost importance to strive for the optimal balance between the cooling-off period for the declared interests versus maintaining the experts’ knowledge’.

55 Furthermore, section 4.2.1.2. of that policy provides that, ‘as general rule, current employment with a pharmaceutical company or current financial interests in pharmaceutical industry are incompatible with involvement in the Agency’s activities. …’

56 In the third place, as is apparent from the wording of section 3.2.2 of the EMA policy, referred to in paragraph 11 above, it is necessary to determine, in a first step, whether a university hospital may be treated in the same way as a ‘research organisation’ and, consequently, be excluded from the scope of the definition of ‘pharmaceutical company’. If so, it will then be necessary to examine, in a second step, whether the fact that a university hospital controls the cell therapy centre, which, it is common ground, is a pharmaceutical company, means that it is deprived of the benefit of that exclusion.

57 On the first point, it follows from the wording of that section that, while the first three subparagraphs define ‘pharmaceutical company’ positively, the last subparagraph thereof excludes from the scope of that definition ‘independent researchers and research institutes, including universities and learned societies’. In the light of the wording used, in particular the expression ‘including’, that list cannot be regarded as being exhaustive.

58 It follows from a purposive interpretation of section 3.2.2 of the EMA policy that university hospitals must be treated in the same way as research organisations.

59 Indeed, first, the name of university hospitals shows the proximity which they have with a university which, for its part, is expressly excluded from the scope of the ‘pharmaceutical company’.

60 Second, as the General Court noted in paragraph 57 of the judgment under appeal, a university hospital has a threefold role of care, education and research. As the Federal Republic of Germany and the Republic of Estonia have argued, universities and university hospitals are dedicated for the most part, and, as a general rule, under the law, to non-profit scientific research in the interest of health, they are bound by a series of strict ethical standards as part of their research and are not involved in the marketing of medicinal products.

61 Third, as the Republic of Estonia, the Kingdom of the Netherlands and the EMA correctly stated both in their written pleadings and at the hearing, the exclusion of university hospitals from the concept of ‘pharmaceutical company’, within the meaning of section 3.2.2 of the EMA policy, helps to strike a balance between the need to carry out, on the one hand, an impartial examination of MA applications for a medicinal product and, on the other hand, a careful and as precise scientific examination as possible of questions which arise during the evaluation of a medicinal product. In order to achieve that balance, it appears necessary, as those parties point out, to authorise the EMA to appoint as experts individuals belonging to the staff of university hospitals since, in accordance with the second paragraph of section 4.2.1.2 of that policy, it cannot appoint in that capacity, except for expert witnesses, individuals employed in the pharmaceutical industry or having current financial interests there.

62 It follows from the foregoing considerations that a university hospital must be excluded from the scope of the concept of ‘pharmaceutical company’ within the meaning of section 3.2.2 of that policy.

63 It is therefore necessary to examine, in a second step, whether the fact that a university hospital controls a pharmaceutical company, in this case the cell therapy centre, leads to the conclusion that that hospital is not covered by that exclusion.

64 According to the fourth and last paragraph of the concept of ‘pharmaceutical company’ defined in section 3.2.2 of the EMA policy, ‘independent researchers and research organisations, including universities and learned societies, are excluded from the scope of the present definition’. Formulated unequivocally, that provision does not provide for any exception to the exclusion for which it provides.

65 The EMA emphasised, in essence, at the hearing, that a university hospital is frequently equipped with a small entity which manufactures medicinal products and meets the criteria for classification as a ‘pharmaceutical company’, either because those medicinal products have a short shelf-life, which presupposes that they can be administered very quickly after they have been manufactured, or because they must be produced from biological material taken from patients. In such a context, the unqualified exclusion of research organisations from the scope of the definition of ‘pharmaceutical company’, within the meaning of section 3.2.2 of the EMA policy, is evidence of the EMA’s intention, in the context of the authorisation granted to it by the EU legislature, as recalled in paragraphs 50 and 51 above, to exclude research organisations from the scope of that definition, and by extension, university hospitals.

66 Furthermore, the application to a university hospital of the criterion of control set out in the third paragraph of the definition of pharmaceutical company would render the exclusion provided for in the fourth paragraph of that definition ineffective. Indeed, that hospital would be entirely deprived of the benefit of that exclusion since it controls an entity meeting the criteria of a pharmaceutical company, regardless of the proportion of its workforce assigned to that entity.

67 To consider that all the staff of a university hospital are employed by a ‘pharmaceutical company’, within the meaning of section 3.2.2 of that policy, would also run against the objective of Article 57(1) of Regulation No 726/2004, read in conjunction with recital 19 thereof, and section 4.1 of that policy, which is to strike an optimal balance between the requirement of impartiality of the scientific committees’ members and the experts participating in the Agency’s activities and the need for scientific advice of the highest possible standard.

68 In the present case, the Republic of Estonia stated at the hearing, relying on the statistics relating to 2021, that such an interpretation would lead to the conclusion that the 4 656 workers employed by the Tartu University Hospital (Estonia), which is the only university hospital of that State, work for a pharmaceutical company, even though only four employees are assigned to the manufacture of medicinal products. The Federal Republic of Germany also stated at the hearing that the largest German university hospital, namely, the Charité Hospital in Berlin, employs 20 900 workers, of which only one hundred, at most, are assigned to the hospital’s commercially oriented manufacturing entities.

69 Thus, the fact of providing for an overall exclusion of university hospital experts from participation in the EMA’s scientific opinions on the ground that such hospitals have, within them, one or more entities capable of constituting pharmaceutical companies, within the meaning of section 3.2.2 of the EMA policy, risks creating a shortage of experts with detailed medical knowledge in certain scientific fields, in particular in relation to orphan medicinal products and advanced medicinal products. According to the documents before the Court, the staff of universities and university hospitals represent the most important part of the network of experts requested by the EMA to give a scientific opinion in the context of the procedure for evaluating an application for MA for a medicinal product.

70 The exclusion from the scope of the concept of ‘pharmaceutical company’, defined in point 3.2.2 of the EMA policy, provided for in the fourth paragraph of that definition, does not, however, apply to entities controlled by a university hospital which themselves satisfy the criteria of a ‘pharmaceutical company’ within the meaning of the first paragraph of that definition.

71 Consequently, individuals employed by an entity controlled by a university hospital or who, more broadly, collaborate with that entity cannot be led to express a scientific opinion for the EMA, if that entity meets the criteria of the concept of ‘pharmaceutical company’, as defined in section 3.2.2 of the EMA policy.

72 An interpretation of that kind is such as to ensure an optimal balance between the requirement of impartiality of the experts involved in the Agency’s activities and the requirement of excellence of the experts called upon.

73 It follows that the General Court erred in law in taking the view in the present case that the university hospital was a ‘pharmaceutical company’, within the meaning of the first paragraph of the definition of those terms set out in section 3.2.2 of the EMA policy, solely because it controlled a cell therapy centre which itself satisfied the criteria of the ‘pharmaceutical company’ within the meaning of that provision.

74 Consequently, the first grounds of appeal in Cases C‑6/21 P and C‑16/21 P, alleging infringement of section 3.2.2 of the EMA policy, must be upheld.

75 Since the first grounds of appeal raised by the Federal Republic of Germany and by the Republic of Estonia have been upheld, the judgment under appeal must be set aside, without it being necessary to examine the other grounds of appeal raised by those parties.