OPINION OF ADVOCATE GENERAL

Sharpston

delivered on 22 April 2010 ( )

Case C‑350/08

European Commission

v

Republic of Lithuania





(Action for failure of a Member State to fulfil obligations – Medicinal products for human use – Accession of new States – Maintenance of a national authorisation for a similar medicinal product derived from biotechnology granted before accession – Principle of compliance with the acquis communautaire)

I – Introduction

1. Grasalva is a medicinal product derived from bio-technology that is used in chemotherapy treatments. ( ) It is similar to another medicinal product, called ‘Neupogen’, already authorised in the European Union. ( )

2. Lithuania authorised Grasalva after the Treaty of Athens ( ) was signed but before it actually came into force on 1 May 2004.

3. Annex IX to the Act of Accession ( ) lays down transitional provisions concerning medicinal products already authorised by Lithuania at the time of signature of the Treaty. Only the 6 151 products on a list (‘the accession list’) contained in that annex could continue to be marketed in Lithuania after 1 May 2004, and then only until their authorisation had been renewed in accordance with the acquis communautaire or until 1 January 2007, whichever was earlier.

4. The accession list thus constitutes the legal basis for allowing, after actual accession, the marketing of certain medicinal products that had been authorised, although not in accordance with Union legislation, before the Treaty of Athens. It must be examined in the light of certain particular features of this case:

– first, the accession list does not address the situation of products which, like Grasalva, were authorised in the period between signature of the Treaty of Athens and its entry into force and which, therefore, could not be included in the list (since the latter formed part of the Treaty of Athens itself);

– second, Lithuania showed exemplary diligence in transposing into national law, ( ) before its accession to the European Union, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (‘Directive 2001/83’), ( ) and it issued an authorisation for Grasalva in accordance with the domestic provisions giving effect to that directive;

– third, there is nothing to suggest that Lithuania acted otherwise than in good faith, given that no provision was made for dealing with applications for authorisation lodged between signature of the Treaty of Athens and 1 May 2004.

5. Against that background, should the Court declare that Lithuania has failed to comply with its obligations merely because it did not withdraw Grasalva from the market on 1 May 2004?

II – Legal background

A – European Union law

1. Authorisation of medicinal products

6. The applicable European Union law (‘EU law’), ratione temporis, clearly lays down two distinct procedures for the authorisation of medicinal products.

7. First, there is a centralised procedure in which the decision-making power is vested in the Commission. That is the mechanism established by Regulation No 2309/93 ( ) which was superseded by Regulation No 726/2004. ( ) I shall refer to that procedure as the ‘Regulation Rules’.

8. Second, there is the decentralised procedure, laid down in Directive 2001/83, which confers power to authorise medicinal products on the Member States under certain conditions. That procedure is maintained, albeit with certain changes, by Directive 2003/63/EC. ( ) I shall refer to that procedure as the ‘Directive Rules’, but without losing sight of the necessary distinction – given the context of the successive legislative developments – between ‘Directive 2001/83’ and ‘Directive 2001/83, as amended’.

a) The Regulation Rules

9. Article 2 of Regulation No 726/2004 provides that ‘... [t]he holder of a marketing authorisation for medicinal products covered by this Regulation must be established in the Community’.

10. Under Article 3 of Regulation No 726/2004, technologically advanced medicinal products, and in particular those derived from biotechnology, such as Grasalva, must be authorised by means of the centralised procedure.

11. Article 3(3) of Regulation No 726/2004 nevertheless recognises that:

‘A generic medicinal product of a reference medicinal product authorised by the Community may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC and Directive 2001/82/EC [( )] under the following conditions:

(a) the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC or Article 13 of Directive 2001/82/EC.’

b) The Directive Rules

i) Directive 2001/83

12. Article 6 (1) of Directive 2001/83 provides:

‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No 2309/93.’

13. According to Article 8(1) and (2) of the Directive:

‘1. In order to obtain an authorisation to place a medicinal product on the market regardless of the procedure established by Regulation (EEC) No 2309/93, an application shall be made to the competent authority of the Member State concerned.

2. A marketing authorisation may only be granted to an applicant established in the Community.’

14. In order to obtain authorisations not falling within the scope of Regulation No 2309/93, Article 8(3)(i) of Directive 2001/83 provides that the results of a series of physico-chemical, biological or microbiological toxicological and pharmacological tests and clinical trials must accompany the application.

15. However, Article 10(1)(a) of Directive 2001/83 waives the requirement to lodge the results of toxicological, pharmacological or clinical tests where, in particular, it can be shown:

‘(iii) … that the medicinal product is essentially similar to a medicinal product which has been authorised within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made. This period shall be extended to 10 years in the case of high‑technology medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council Directive 87/22/EEC. …

…

However, where the medicinal product is intended for a different therapeutic use from that of the other medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate toxicological and pharmacological tests and/or of appropriate clinical trials must be provided.

…’

16. Article 126 of Directive 2001/83 provides that an authorisation to market a medicinal product may be withdrawn only in very specific circumstances, none of which are relevant to the present proceedings.

ii) Directive 2001/83, as amended

17. Directive 2003/63 modifies, in the light of scientific and technical progress, certain requirements which were previously imposed by Directive 2001/83. In particular, it inserts a new Annex I into Directive 2001/83 entitled ‘Analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products’.

18. A notable change is that, in Section 4 of Part II of Annex I to Directive 2001/83, which deals with similar biological medicinal products, additional requirements are introduced for the registration of such products:

‘The provisions of Article 10(1)(a)(iii) may not be sufficient in the case of biological medicinal products. If the information required in the case of essentially similar products (generics) does not permit the demonstration of the similar nature of two biological medicinal products, additional data, in particular, the toxicological and clinical profile, shall be provided.

…

The general principles to be applied are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency. In case the originally authorised medicinal product has more than one indication, the efficacy and safety of the medicinal product claimed to be similar has to be justified or, if necessary, demonstrated separately for each of the claimed indications.’

2. The Accession Treaty

19. Article 2(2) of the Treaty of Athens provides that it is to ‘enter into force on 1 May 2004 provided that all the instruments of ratification have been deposited before that date’.

3. The Act of Accession

20. According to Article 2, ‘[f]rom the date of accession, the provisions of the original Treaties and the acts adopted by the institutions and the European Central Bank before accession shall be binding on the new Member States and shall apply in those States under the conditions laid down in those Treaties and in this Act’.

21. Article 54 provides that ‘[t]he new Member States shall put into effect the measures necessary for them to comply, from the date of accession, with the provisions of directives and decisions within the meaning of Article 249 of the EC Treaty and of Article 161 of the Euratom Treaty, unless another time-limit is provided for in the Annexes referred to in Article 24 or in any other provisions of this Act or its Annexes’.

22. Article 57(1) of the Act of Accession provides that, where acts of the institutions adopted before accession needed to be adjusted as a result of accession ‘and the necessary adaptations have not been provided for in this Act or its Annexes, those adaptations shall be made in accordance with the procedure laid down by paragraph 2. Those adaptations shall enter into force as from accession’.

23. Specifically, Article 24 of the Act of Accession lays down a number of transitional measures, indicating that the ‘measures listed in Annexes V, VI, VII, VIII, IX, X, XI, XII, XIII and XIV to this Act shall apply in respect of the new Member States under the conditions laid down in those Annexes’.

24. Annex IX to the Act of Accession deals with transitional measures for Lithuania. The second part of Chapter 1 of Annex IX indicates that:

‘By way of derogation from the requirements of quality, safety and efficacy laid down in Directive 2001/83/EC, marketing authorisations for the pharmaceutical products on the list (in Appendix A to this Annex as provided by Lithuania in one language) issued under Lithuanian law prior to the date of accession, shall remain valid until they are renewed in compliance with the acquis and in accordance with the timeframe set out in the abovementioned list, or until 1 January 2007, whichever is the earlier. Notwithstanding the provisions of Title III, Chapter 4, of the Directive, marketing authorisations covered by this derogation shall not benefit from mutual recognition in the Member States.’

25. Appendix A of Annex IX to the Act of Accession incorporates the accession list, comprising 6 151 medicinal products, among which Grasalva does not appear, and indicates that, although these products are covered by the transitional rules, ‘[m]ention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing authorisation in compliance with the acquis’.

B – Lithuanian law

26. By means of Ministerial Decree No 669 of 22 December 2001 on the rules for registration of general medicinal preparations (‘the 2001 Decree’), Lithuania transposed Directive 2001/83 into national law.

27. In compliance with Article 10(1)(a) of Directive 2001/83, Article 18, third paragraph, of the 2001 Decree waives the obligation to provide the results of pre-clinical trials or of clinical investigations for the purposes of authorising the marketing of medicinal products, provided that certain requirements are met.

28. The 2001 Decree was due to come into effect on 1 January 2004.

29. However, Decree V-169 of 24 March 2003 of the Minister of Public Health (‘the 2003 Decree’) amended the 2001 Decree and brought forward its entry into force to 1 April 2003. ( )

III – The essential facts and their chronology

30. The sequence of events is particularly important in this case. I shall therefore describe the successive stages and events in detail.

31. Regulation No 2309/93 was adopted on 22 July 1993 and, according to Article 74, it was to enter into force ‘on the day following the decision taken by the competent authorities on the headquarters of the Agency’. The place chosen for the Agency was London, as indicated in the conclusions of the Presidency of the Extraordinary European Council held in Brussels on 29 October 1993. The Agency commenced operations on 1 January 1995.

32. On 6 November 2001, Directive 2001/83 was adopted. Under Article 8(1), the Member States were empowered to authorise the marketing of a medicinal product in those cases where the procedure established by Regulation No 2309/93 was not applicable. However, Article 10(1)(a) of the Directive laid down a simplified and more flexible procedure for obtaining authorisation for essentially similar generic medicinal products, thereby relieving an applicant (in the cases for which it provides) of the obligation to provide the results of toxicological and pharmacological tests or of clinical trials. ( )

33. On 18 December 2001, Directive 2001/83 was published in the Official Journal of the European Communities. It entered into force on the twentieth day following its publication, as provided by Article 129 thereof.

34. On 22 December 2001, only four days after Directive 2001/83 was published, Lithuania laid down rules (in the 2001 Decree) for the registration of general medicinal preparations. Lithuania thus promptly and diligently transposed the Directive into national law, even though it was not yet under any obligation to do so (since Lithuania was then merely a candidate country for accession to the European Union). In particular, Article 18, third paragraph, of the 2001 Decree introduced a simplified authorisation procedure, as provided for in Article 10(1)(a) of the Directive. It appears that Lithuania initially intended to apply the Directive as from 1 January 2004, the date then envisaged for Lithuania’s accession to the Union.

35. On 30 November 2002, Lithuania participated for the first time, as observer, in the committee analysing new Union legislation on medicinal products (‘the Pharmaceuticals Committee’), to which Directive 2003/63, amending Directive 2001/83, was submitted for consideration.

36. On 24 March 2003, by means of the 2003 Decree, Lithuania brought forward to 1 April 2003 the entry into force of its national legislation transposing Directive 2001/83. As a result, the 2001 Decree allowed the authorisation, as from 1 April 2003, of products that were in conformity with Directive 2001/83.

37. On 16 April 2003, Lithuania signed the Treaty of Athens, to which was annexed the accession list of 6 151 medicinal products, unilaterally drawn up by Lithuania without any suggestions or guidelines from the Commission and without any need for the list to be verified. ( )

38. On 16 April 2003, the day on which the Treaty of Athens was signed, the accession list was therefore closed, Moreover, no procedure was laid down for medicinal products to be added subsequently to the list.

39. On 8 May 2003, an application for the authorisation of Grasalva was submitted to the Lithuanian authorities, who contacted the manufacturer to obtain its view as to the possible inclusion of that medicinal product on the accession list. The manufacturer turned down the suggestion, since it considered Grasalva to comply fully with the requirements of Directive 2001/83. ( )

40. On 25 June 2003, Directive 2003/63 was adopted. A new Annex I was substituted into Directive 2001/83. As a result, it became impossible to approve generic medicinal products derived from biotechnology, like Grasalva, under the simplified procedure. Directive 2003/63 did not alter Article 6 of Directive 2001/83, concerning competence for authorisation.

41. On 27 June 2003, Directive 2003/63 was published in the Official Journal of the European Union.

42. Directive 2003/63 entered into force on 30 June 2003, three days after its publication, as provided in Article 3 thereof. However, the period for its transposition did not end until 31 October 2003.

43. On 2 July 2003, Grasalva was authorised under the simplified procedure, on the basis of Article 18, third paragraph, of the 2001 Decree. By authorising Grasalva under the 2001 Decree, which transposed Directive 2001/83, the Lithuanian authorities considered that they were doing what they were permitted to do. That would indeed have been the case had Lithuania been a Member State at the relevant time.

44. On 23 September 2003, the Treaty of Athens, including the accession list which forms part of it, was published in the Official Journal of the European Union.

45. The period for transposing Directive 2003/63 came to an end on 31 October 2003. Thereafter, all applications for authorisation had to comply with the more restrictive rules laid down in Annex I to Directive 2001/83, as amended.

46. On 31 March 2004, Regulation No 726/2004 was adopted.

47. On 30 April 2004, Regulation No 726/2004 was published in the Official Journal of the European Union.

48. On 1 May 2004, Lithuania acceded to the European Union. From that time onwards, it was possible to authorise medicinal products under the centralised procedure in accordance with the Regulation Rules. It was, however, also necessary to observe the relevant requirements of the Directive Rules.

49. On 20 May 2004, Regulation No 726/2004 entered into force, that is to say 20 days following its publication in the Official Journal of the EuropeanUnion, as indicated in Article 90(1) thereof, although Article 90(2) states that, by way of derogation from the first paragraph, Titles I (Definitions and scope), II (Authorisation and supervision of medicinal products for human use), III (Authorisation and supervision of veterinary medicinal products) and V (General and final provisions) were to apply from 20 November 2005 and certain points of the Annex were to apply from 20 May 2008.

50. On 15 December 2006, the Commission initiated the pre-contentious procedure under Article 226 EC.

51. On 29 June 2007, the Commission issued a reasoned opinion, allowing a period of two months for the infringement to be brought to an end.

52. That period expired on 29 August 2007.

53. On 29 January 2008, a request was submitted, under Regulation No 726/2004, for authorisation of the medicinal product Thevagrastine, which is similar to Grasalva. That application was lodged at a time when the Lithuanian authorisation for Grasalva was coming to an end.

54. On 2 July 2008, the Lithuanian authorities withdrew Grasalva from the market. By declaring that Grasalva’s authorisation expired five years after it was issued, they thus acted consistently with their understanding of the Directive Rules. ( )

55. On 29 July 2008, the Commission brought the present proceedings under Article 226(2) EC.

56. On 15 September 2008, Thevagrastine was authorised, almost eight months after the application was submitted. That may indicate that the manufacturer had an erroneous impression of how long the centralised procedure would take.

IV – Arguments of the parties

A – The Commission’s position

57. The Commission asks the Court to declare that Lithuania has infringed EU law by keeping the medicinal product Grasalva on the market after 1 May 2004, on the basis of an authorisation which, in the Commission’s view, did not satisfy the prescribed requirements.

58. First, the Commission criticises Lithuania for not observing the Directive Rules, specifically Article 6(1) of, and Section 4 of Part II of Annex I to, Directive 2001/83, as amended, which formed part of the Union acquis as at the date of actual accession.

59. The Commission considers that, regardless of whether the 2001 Decree was in conformity with Directive 2001/83 when Grasalva was authorised, Directive 2001/83, as amended, prevented its being marketed after 1 May 2004. The amended Directive precluded recourse to the simplified procedure, the very procedure used to authorise Grasalva. On the contrary, Directive 2001/83, as amended, made marketing of that medicinal product subject to observance of all the requirements for its authorisation.

60. Moreover, Lithuania could not continue to permit Grasalva to be marketed after accession because that product was not included on the accession list and thus could not benefit from the transitional rules associated with that list.

61. The Commission also complains that the presence of Grasalva on the market after 1 May 2004 infringes the Regulation Rules (in particular, Article 3(1) of Regulation No 2309/93 and Article 3(1) of Regulation No 726/2004). As a medicinal product derived from biotechnology, Grasalva could only be authorised under the centralised procedure.

62. In short, the Commission asserts that, following Lithuania’s accession, the Union acquis prohibited the marketing of Grasalva.

B – Lithuania’s position

63. Lithuania contends that the application is inadmissible, submitting that it is devoid of purpose, and that the Commission’s decision to bring the action is arbitrary.

64. Substantively, Lithuania bases its defence on the fact that Grasalva was authorised in conformity with all the requirements of Article 10(1)(a) of Directive 2001/83, the only requirements which, in its view, it had to satisfy. At the relevant time, Directive 2001/83, as amended, was not applicable.

65. Lithuania further submits that it was not obliged to transpose Directive 2003/63 before 31 October 2003. No infringement was therefore committed when Grasalva was authorised on 2 July 2003.

66. In Lithuania’s view, only authorisations for which applications were made after Directive 2003/63 became an operational part of the acquis were required to comply with that Directive. The new conditions it introduced could not apply to authorisations already granted. Otherwise, States which joined the Union in 2004 would be discriminated against as compared with the 15 Member States that were already members when Directive 2003/63 was adopted, since the latter were entitled to keep products already authorised under Directive 2001/83 on the market, whereas the new Member States would be required to withdraw them or else renew the authorisations in accordance with Directive 2003/63.

67. Lithuania considers that withdrawing Grasalva from the market in instances other than those exhaustively listed in Article 126 of Directive 2001/83 would run counter to the principle of legality. None of the circumstances identified in that article applied to Grasalva.

68. Finally, Lithuania argues for the application by analogy of the ‘pipeline’ case-law, under which certain environmental authorisations have nevertheless been held to be valid, despite the fact that the acquis made it necessary to change the legislation covering the authorisation, since a re-run of the procedure would, owing to its complexity, give rise to more problems than advantages as regards both efficacy and legal certainty.

V – Admissibility of the application

69. Lithuania claims the application is devoid of purpose. It is inappropriate to ask the Court to order that an infringement be brought to an end when the circumstances which gave rise to it have already ceased to exist.

70. Lithuania points out that Grasalva was withdrawn from the market one month before the Commission lodged its application. The contested authorisation has now lapsed and is of no effect.

71. Lithuania therefore asserts that, in bringing the action, the Commission was guilty of a degree of arbitrariness, contrary to the principle of sound administration. ( ) Lithuania also draws attention to the fact that the application was lodged 11 months after the end of the period laid down in the reasoned opinion, and was thus clearly a belated reaction.

72. I do not agree with Lithuania’s objection.

73. Having initiated the pre-litigation procedure, the Commission issued its reasoned opinion on 29 June 2007. It set a period of two months for the infringement to be brought to an end, thereby giving Lithuania an opportunity to withdraw Grasalva from the market by 29 August 2007.

74. Grasalva was still being marketed in Lithuania on that date. Given that its authorisation did not lapse until 2 July 2008, the problem complained of manifestly persisted at the end of the period laid down by the reasoned opinion (the reference point for deciding whether an infringement has taken place, regardless of any subsequent developments). ( )

75. The objective nature ( ) of the Treaty-infringement procedure further undermines Lithuania’s argument. It is for the Commission alone to decide whether it is appropriate to commence such proceedings; and it enjoys considerable discretion in selecting the relevant act or omission to challenge.

76. The case-law also makes it clear that the Commission can choose when to initiate proceedings, and the considerations underlying its decision cannot affect the admissibility of its application. ( )

77. That rule is nuanced if the excessive duration of the pre-litigation procedure has made it more difficult for the defendant Member State to refute the Commission’s arguments, in breach of its rights of defence. However, such a breach must be alleged and proved by the State concerned. ( )

78. In the present proceedings, Lithuania has not suggested that that is the case. Indeed, the richness of the arguments that it raises demonstrates that its rights of defence have not been jeopardised.

79. The possibility that the adverse consequences of an infringement may persist after it has been terminated ( ) likewise militates against rejection ad limine.

80. Even if the underlying cause of action has disappeared by the time the application is lodged, there is still an interest in guaranteeing the integrity of EU law. ( ) To put it another way: there may be an advantage in maintaining an action before the Court even though the original problem no longer exists.

81. Finally, the issue being litigated here may arise again in the future as a result of further enlargement of the European Union. There may conceivably be gaps in the transitional arrangements governing new accessions; and the guidance given by the Court in the present case may prove helpful.

82. For those reasons, Lithuania’s objection as to admissibility cannot succeed.

VI – Analysis

A – Preliminary considerations

83. First, the two systems for marketing medicinal products (under the Directive and under the Regulation) appear to operate on a mutually exclusive basis, each within its own specific area. How, then, are they meant to coexist in harmony?

84. Second, both the Directive Rules and the Regulation Rules require the person responsible for putting the medicinal product onto the market to be established within the Union. Interpreted literally, it is clear that authorisation should not be granted for any substance distributed by someone established in a third country.

85. Obviously, any person established in a State like Lithuania which, in July 2003, was not yet a Member State was, by definition, not established within the Union. In the absence of any additional legislative provisions governing this matter during the period preceding accession, any application for authorisation from such a person would presumably have failed.

86. Third, the accession list, incorporated in Annex IX to the Act of Accession, constitutes a legal basis for permitting certain medicinal products to remain on the market, despite not fulfilling the requirements of Directive 2001/83. Taken in isolation, that might lead one to suppose that the accession list derogates from certain aspects of the Directive Rules but not from the Regulation Rules, which the accession list does not mention. That would run counter to the Commission’s view that, if Grasalva had only been included on that list, it could have been marketed after 1 May 2004. ( )

87. Fourth, it is apparent that there is a real lacuna in the transitional system for authorising medicinal products. There are no arrangements to cover applications for authorisation submitted between 16 April 2003, when the Treaty of Athens was adopted (and when, therefore, the list became fixed and final) and 1 May 2004 (the date of actual accession).

88. It is unclear what the parties to the Act of Accession envisaged should happen during that period. I examine below the different (and contradictory) courses of action that the Commission and Lithuania suggest for dealing with this problem.

89. Fifth, the 2001 Decree was specifically promulgated to give effect to Directive 2001/83. The Commission has not suggested that the transposition was in any way flawed or incomplete. If Lithuania had been a Member State between 1 April 2003 and 31 October 2003 (the end of the transitional period under Directive 2003/63), the 2001 Decree would have enabled Grasalva to be authorised on 2 July 2003 ‘in accordance with’ the legal requirements of the Directive Rules.

B – The Directive Rules and the Regulation Rules

1. The relationship between the two sets of rules

90. The two sets of rules cannot properly be read in isolation from each other. They must be considered together. The substantive requirements relating, essentially, to the quality and safety of medicinal products are found in the Directive Rules; but it is apparent that those conditions must, nevertheless, also be observed when recourse is had to the centralised procedure provided for in the Regulation Rules.

91. That can be derived from the fact that, in Regulation No 726/2004, recital 14 provides that the quality, safety and efficacy criteria laid down in Directives 2001/82 and 2001/83 are to apply to medicinal products authorised by the Community, Article 2(1) refers directly to the definitions in Article 1 of Directive 2001/83 and Article 6(1) requires each application for authorisation of a medicinal product for human use under the centralised procedure to include, in full, the specific data and documents referred to in Articles 8(3), 10, 10(1)(a), 10(1)(b) and 11 of, and Annex I to, Directive 2001/83.

92. In short, the Regulation Rules contain a number of provisions that are essentially procedural (see Article 1 of the Regulation). In contrast, the Directive Rules, although they make certain procedural references to decentralised authorisation (national competence), essentially contain substantive provisions regarding the standards to be observed to uphold product quality and protect human health.

93. The choice as to whether a particular substance is approved under the national procedure or under the centralised procedure cannot be made at random. Neither the Directive Rules nor the Regulation Rules leave any room for such a choice. Depending on the origin, component substances or category of the medicinal product in question, one or the other authorisation procedure must be used.

94. However, given that the substantive requirements are common to all medicinal products, if a given product were to be refused authorisation under the national procedure because it failed to satisfy certain standards, another parallel product which failed to meet those same standards could not be authorised under the centralised procedure.

95. Finally, as a generic medicinal product derived from bio-technology, Grasalva should have been authorised under the centralised procedure. That is to be inferred from Article 3 of Regulation No 2309/93 and the annex thereto.

2. The relationship between the two sets of rules and the accession list

96. The analysis I have just set out supports, to some extent, the Commission’s thesis, which is based on an overall view of the two systems. It helps to circumvent the obstacle identified in the third of my preliminary considerations (as to whether Grasalva could have remained on the market after 1 May 2004 if it had been included on the accession list, even though it should have been authorised by the centralised procedure and that list did not expressly derogate from the Regulation Rules).

97. Essentially, it seems to me that that problem is best solved by a teleological rather than a literal interpretation. Whilst it is true that the accession list derogates specifically only from the Directive Rules, Article 6 of Directive 2001/83 also refers to medicinal products that have to be authorised under the centralised procedure.

98. That provision prohibits the placing on the market of any medicinal product unless the Member State has granted an authorisation ‘in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No 2309/93’ (my emphasis).

99. The second part of Chapter 1 of Annex IX to the Act of Accession (to which the accession list is appended) focuses on the substantive quality, safety and efficacy requirements of Directive 2001/83. It is not much concerned with procedure. Directive 2001/83 is essentially a substantive measure. Those parts of it that are procedural point directly to the national authorisation procedure but also contemplate and recognise, by referring to the Regulation Rules, the centralised Union procedure.

100. The two sets of rules are not designed as separate worlds. They cross-refer to each other. Thus, the Directive Rules acknowledge the existence of the centralised procedure; and the Regulation Rules allow for certain national authorisations. ( )

101. I therefore consider that the accession list, sensibly interpreted, must operate so as to derogate from both regimes: the Directive Rules and the Regulation Rules.

102. That thesis is supported by a factor which must not be overlooked and that stems from the whole logic of the accession list system. The 6 151 medicinal products comprised in that list were authorised by Lithuania. It is reasonable to suppose that some were products that fell within the scope of the Regulation Rules rather than the Directive Rules. The accession list nevertheless enabled them to remain on the market in Lithuania after 1 May 2004.

C – A lacuna in the mechanism for Lithuania’s accession

103. It is clear from an analysis of the relevant texts, as confirmed by the parties at the hearing, that the accession list made no provision for the addition of new medicinal products between 16 April 2003 and 1 May 2004.

104. There is no reason to think that, during that intervening period, Lithuania ceased to be competent to authorise new products whilst (naturally) remaining competent to maintain products on the market. As I see it, nothing prevented the Lithuanian authorities from authorising a new medicinal product. The more delicate question, which has given rise to the present proceedings, is whether such an authorisation would remain effective beyond the accession date.

105. Against that background, why did the accession list not deal with this issue? Of course, Union legislation cannot, as a general rule, be projected back into the period before accession. Lithuania acquired its status as a Member State on 1 May 2004. The problem here precedes that date. Can it, strictly speaking, be described as a purely domestic issue?

106. From a temporal and technical point of view, that approach is correct. Ultimately, the parties to an accession Treaty are, on the one hand, the Member States of the Union and, on the other, the candidate States. The Union as such merely stands on the sidelines for this initial agreement.

107. The accession process is nevertheless meant, as far as possible, to resolve any conflicts that may arise. Special attention has to be paid to periods immediately before and after accession. Unfortunately, in this particular instance, the necessary forethought does not appear to have been shown, either (perhaps understandably) by Lithuania, or by the Union (whose executive authority – the Commission – could reasonably be expected to take responsibility for overseeing the complex process of accession, even though the Union itself was not party to the Accession Treaty).

108. The Commission, now aware of the problem, has put forward a number of suggestions for dealing with the lacuna, arguing that Lithuania was not left unable to fulfil its obligations. I cannot endorse any of them.

109. The Commission suggests that Lithuania could, for example, have made use of its status as an observer State from 30 November 2002 onwards to intervene within the Pharmaceutical Committee responsible for making suggestions and proposals concerning Union legislation, such as Directive 2003/63, that was in the process of being adopted.

110. The Commission also invokes Article 57 of the Act of Accession to support the proposition that Lithuania could have requested an amendment of EU law in view of the situation that had arisen concerning Grasalva. According to the Commission, Lithuania could have requested a special derogation from Directive 2003/63 or sought approval for a transitional regime enabling it to overcome these difficulties. It could even have raised the specific question of how Grasalva could lawfully be authorised.

111. It is true that, as from the date of the Treaty of Athens, the accession States acquired the status of ‘active observers’ within all the Council organs and could take part in all meetings and deliberations, albeit without voting rights.

112. Furthermore, the Final Act of the Accession Treaty ( ) deals in detail with the various aspects of the reporting and consultation procedure.

113. In my opinion, Lithuania could indeed have made enquiries before going ahead with authorising further medicinal products after 16 April 2003. However, I very much doubt that such an approach would have ‘solved’ the present case. A State with mere observer status has scant influence on the final terms of a legislative instrument such as Directive 2003/63.

114. Indeed, it rather seems as though Lithuania was unaware that there was a problem. It appears to have proceeded on the basis that, provided it aligned its domestic law with the acquis prior to accession, and applied the new rules diligently, all would be well. I find it difficult to blame a candidate country for taking that approach. By definition, it does not have prior experience of the problems that accession can throw up. The responsibility surely lies with the Union – and, in particular, with the Commission, which does have considerable experience of previous accessions – to play an active role in identifying potential problems and suggesting ways of resolving them. Regrettably, that does not seem to have happened here.

115. Against that background, the fundamental problem in my view lies in the impossibility of making, by means of secondary law (that is, by inserting in Directive 2003/63 an ad hoc derogation or specific transitional provision), amendments to an entire legal structure created as part of primary law, namely the accession list system. ( )

116. Obviously, the elementary principle of the hierarchy of norms prohibits this. It would be difficult to justify why Lithuania, which had accepted the accession list system on 16 April 2003, should be able simultaneously to solicit an amendment to Directive 2003/63 that would frustrate the intention of the list system so as to allow Grasalva to be marketed after 1 May 2004 even though it does not figure on the accession list.

117. I must therefore conclude that there is a lacuna in the accession system; and that there is no way of remedying that deficiency effectively. The essential questions then become: what was Lithuania meant to do about authorising medicinal products between 16 April 2003 and 1 May 2004? And was what it did do lawful?

D – The discrimination alleged by Lithuania

118. In Lithuania’s view, only applications for the authorisation of medicinal products lodged after Directive 2003/63 became an operational part of the acquis had to comply with that Directive. Authorisations already granted were not affected.

119. Lithuania considers that there would otherwise be discrimination against the States that entered the Union in 2004, as compared with the 15 existing Member States. The Commission’s interpretation is one that does so discriminate. Whilst the 15 States that were members when Directive 2003/63 came into force were able to keep their products on the market without any problem, the States that joined in 2004 would have to withdraw them.

120. That contention must be rejected since the principle of equal treatment is infringed ( ) where comparable situations are treated differently, to the disadvantage of certain persons or entities as compared with others, ( ) unless there is objective, necessary and adequate justification ( ) for the attainment of a legitimate purpose. ( )

121. One of the principal difficulties always lies in selecting the correct comparator. If the circumstances are not comparable, in all respects, ( ) any analysis as to whether there is equal treatment is an empty exercise.

122. The comparison suggested by Lithuania is just such a false comparison – and, in any event, it also operates to Lithuania’s disadvantage.

123. That is because the principle of equal treatment is also infringed where the same consequences are assigned to differing situations. Lithuania’s argument is incorrect because Lithuania was not a Member State when Directive 2001/83 and Directive 2003/63 were enacted and was therefore in a different situation from that of a Member State. No valid comparison can therefore be made.

124. It must be borne in mind that, if one of the existing 15 Member States authorised a medicinal product under Directive 2001/83, Article 24 of that Directive permitted it to maintain that product on the market for a period of five years, unaffected by Directive 2003/63. Although Lithuania relies on that provision to claim that Grasalva’s authorisation lapsed only after that five year period (on 2 July 2008 and not before), Article 24 itself does not support Lithuania’s argument.

125. The Union acquis is not fully applicable until the moment of accession. It is therefore immaterial whether or not the Lithuanian legislation was in conformity with Directive 2001/83 (in its original or amended version) before 1 May 2004. At that stage, Lithuania was under no obligation whatsoever to comply with EU law and, of course, the Commission did not have a duty to keep its legislative initiatives under surveillance, backed by the possibility of invoking Treaty-infringement proceedings.

126. Despite its defects, the accession list provided Lithuania with a device that enabled it to keep its pharmaceutical products temporarily on the market after accession. It thus operated as a substitute for, among other provisions, Article 24 of Directive 2001/83, on which Lithuania could not rely.

127. The accession list system is, essentially, a special regime that permitted certain medicinal products authorised and registered before accession to continue to be sold in Lithuania (but not in other Member States) after accession. The premise on which the accession list is based is that the authorisations granted to those medicinal products did not comply with EU law. The mechanism enabled those responsible (unless they decided not to keep a particular medicinal product on the market) to follow, as from actual accession, the necessary procedures to obtain the requisite authorisation for that medicinal product. Viewed from that perspective, the fact that Grasalva happened to comply with the Union rules in force at the moment when it was authorised by the Lithuanian authorities is nothing more than pure coincidence.

128. In short, the disparities in the options available to existing Member States and new Member States arise as a result of the existence of two separate worlds (or dimensions), the clear frontier between them being whether the State was or was not a member of the Union when it authorised the medicinal product in question.

129. If one takes Lithuania’s argument to its logical conclusion, nothing would have prevented Grasalva from being marketed without hindrance throughout the Union, thus obtaining an advantage over other medicinal products that were included in the accession list. Seen in those terms, Lithuania’s argument can only be rejected.

E – Compliance with the Union acquis

130. The Court has, of course, no jurisdiction to investigate whether the authorisation of Grasalva on 2 July 2003 was in conformity with EU law and, specifically, Directive 2001/83, since that authorisation was granted before Lithuania joined the Union. ( )

131. For that reason, the scope of the present application is limited to determining whether or not on 1 May 2004 Grasalva was a medicinal product that had been endorsed under EU law.

132. For the purposes of answering that question, it is irrelevant whether or not Lithuania issued an authorisation that was in conformity with Directive 2001/83. Since Lithuania was not part of the Union at that stage, the issue cannot be approached from that angle. Moreover, even if the authorisation was one that might have satisfied the Directive Rules, the manufacturer of Grasalva was not entitled to seek an authorisation under those rules from the Lithuanian authorities, because they were not entitled to issue it. The only possibility was the centralised procedure which, at that stage, could likewise not be used. ( )

133. Did the acquis permit Grasalva to be marketed at the date of accession? ( ) The answer must be that it did not. The answer could only be otherwise if Grasalva had been included on the accession list.

134. But Grasalva was not on the list.

135. The immediate and full application of EU law in the accession States derives from Articles 2 and 7 of the Act of Accession. It follows that derogations are allowed only if they are expressly provided for in transitional provisions, ( ) in order to safeguard certain situations that have become consolidated.

136. The Act of Accession, founded as it is on the primacy of the entire acquis, established the accession list system solely – so far as I can see – in order to allow the temporary marketing of medicinal products that were in circulation at the moment of accession on the basis of a national authorisation.

137. Perhaps that was why Lithuania, faced by an almost insoluble problem (the impossibility of adding medicinal products to the accession list between 16 April 2003 and 30 April 2004), acted unilaterally and took the view that Directive 2001/83 was applicable, thus endowing itself – fallaciously – with a legal basis under EU law for authorising medicinal products during that period. The mistake, understandable though it may be, is none the less a mistake. The only authorisations that Lithuania could grant under the 2001 Decree for medicinal products that were not included on the accession list were authorisations valid under national law until 30 April 2004.

138. I also consider the argument that Article 126 of Directive 2001/83 prevented the withdrawal of Grasalva from the market (because withdrawal is permitted only on the grounds that that article enumerates exhaustively) to be flawed. The principle of legality does not bite here, because withdrawal of authorisation in accordance with Article 126 presupposes that the authorisation was initially granted in a context in which Directive 2001/83 was fully applicable. That was obviously not the case so far as Lithuania was concerned on 2 July 2003, the date on which Grasalva was authorised.

F – The ‘pipeline’ case-law

139. Lithuania invites the Court to apply by analogy the ‘pipeline’ case-law ( ) which has upheld the validity of certain environmental authorisations, despite the fact that the acquis required the legislation governing the authorisations to be amended, since the procedure was so complex that requiring it to be repeated would give rise to more problems than advantages, in terms both of efficacy and of legal certainty.

140. Those decisions of the Court took the crucial date to be the final date for the implementation of Directive 85/337, ( ) namely 3 July 1988. Where the application for consent for a project was formally lodged before that date, the Court has declared Directive 85/337 inapplicable. Assessments which commenced at a later stage have, however, been required to comply with that Directive. ( )

141. In reality, the accession list system can be seen as a manifestation of the ‘pipeline’ case-law in relation to medicinal products authorised before the Treaty of Athens was signed (with the difference that the accession list confers limited recognition of validity on the basis of an agreement adopted as part of primary law). A product included on the list might be marketed in Lithuania. If it was not included, it could not be so marketed. Whether a product was included on the list before 16 April 2003 depended exclusively on the Lithuanian authorities.

142. What of the medicinal products authorised between 16 April 2003 and 30 April 2004 inclusive – the only products to which the ‘pipeline’ case-law might be applicable?

143. The argument runs as follows: those medicinal products should be able to benefit from the ‘pipeline’ case-law, albeit in a limited way. The limitation would consist in allowing them to be marketed only in Lithuania, applying the same time-limits and conditions as apply to products included on the accession list. ( ) The Commission has produced no evidence that Grasalva has been marketed outside Lithuania. The consequence of applying the ‘pipeline’ case-law would be to dismiss the Commission’s application.

144. The arguments in support of applying the ‘pipeline’ case-law to the present case are based on the advantages which it provides as a way of filling the obvious lacuna I have identified earlier, namely, the lack of any mechanism to enable medicinal products to be added to the accession list.

145. On the one hand, the medicinal products on the list were put there by the Lithuanian authorities on the basis that they represent no danger to the Lithuanian population (despite not having been authorised in accordance with EU law). On the other hand, the Lithuanian legislation in force when Grasalva was authorised was (it would appear, and the Commission has not claimed otherwise) in conformity with EU law. Those two factors show that, in the present case, application of the ‘pipeline’ case-law would not, from a substantive point of view, give rise to any risk to public health.

146. However, there are other arguments which I find more convincing for not allowing an extension of the ‘pipeline’ case-law here.

147. First, it must not be forgotten that Lithuania agreed – at the level of primary law – that after accession only medicinal products on the accession list would be marketed. In that regard, the heading of the accession list is unequivocal in its wording: ‘List as provided by Lithuania in one language of pharmaceutical products for which a marketing authorisation issued under Lithuanian law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or until 31 December 2006, whichever is the earlier. Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing authorisation in compliance with the acquis’ (Appendix A to Annex IX of the Act of Accession).

148. Second, in so far as the ‘pipeline’ case-law represents an exception to the immediate application of the Union acquis as from the time of accession, the Court should be careful to extend its application only to exceptional cases.

149. In that respect, although the procedure for authorising a medicinal product requires some time, in order to study the file, it is certainly not comparable to the extraordinarily complex procedure that has given rise to the ‘pipeline’ case-law regarding the evaluation of possible environmental risks arising from large-scale public works projects.

150. Third, it seems to me that Advocate General Kokott draws a helpful distinction, in Commission v Austria, ( ) between procedural and substantive provisions, ( ) suggesting that the ‘pipeline’ case-law may be applied to the former but not the latter.

151. I think the distinction she proposes may be relevant to the present case, bearing in mind that the Directive Rules contain more substantive than procedural elements, whereas procedural aspects predominate in the Regulation Rules.

152. Consequently, unlike the cases where the ‘pipeline’ case-law has been applied, it is not a matter here of alleviating the effects of a new procedural rule by limiting its effect in time. On the contrary, it is clear in this case that, in reality, the accession list put into abeyance the entire corpus of Union rules for authorising medicinal products (both procedural and substantive aspects). Applying the ‘pipeline’ case-law to products (like Grasalva) that were authorised between 16 April 2003 and 30 April 2004 would likewise necessarily involve limiting the application, not only of the procedural aspects of the relevant Union rules, but also the substantive aspects.

153. For all these reasons, I conclude that it is not appropriate to apply the ‘pipeline’ case-law in the present case.

154. I should however stress that my approach might have been different if the manufacturer of Grasalva had applied for a new authorisation under the new rules reasonably promptly after 1 May 2004. In those circumstances, respect for the principle of legitimate expectations might have militated in favour of extending the validity of the earlier authorisation on a transitional basis. However, that did not happen here.

G – A critical epilogue

155. It seems to me, frankly, that – in terms of the exercise of discretion under Article 226 EC – this application should never have been brought.

156. There is nothing to suggest that Lithuania acted otherwise than in good faith. The mechanism for dealing with the gap of over a year between the signing of the Treaty of Athens (16 April 2003) and the date of accession (1 May 2004) was wholly inadequate – indeed, apparently non-existent. (It is also entirely unclear why the Commission focused on one medicinal product (Grasalva). As the agent for Lithuania very fairly acknowledged at the hearing, certain other medicinal products were granted similar authorisations under the 2001 Decree and continued in circulation after 1 May 2004.)

157. If there has been a breach of EU law, it lies at the polar opposite of the kind of action by a Member State that is a serious and manifest disregard of its obligations. An accession State that implements correctly part of the Union acquis prior to accession and then acts as though it were already a Member State in terms of applying and enforcing that acquis is normally to be congratulated rather than censured.

158. With considerable reluctance, I have nevertheless come to the conclusion that – on a strict reading of the texts of the relevant provisions – the Commission’s application is well founded. A person not established in a Member State cannot, under the Directive Rules, obtain a marketing authorisation for a medicinal product through his national authorities. Nor (for the same reason) can such a person request authorisation from the centralised authorities under the Regulation Rules.

159. In short, although the Lithuanian authorities could authorise the marketing of Grasalva in Lithuania up to 30 April 2004 under the 2001 Decree as a matter of national law, they had no competence to grant an authorisation that would be valid, as a matter of EU law, on and after 1 May 2004. Only including a medicinal product in the accession list enabled it to be marketed after accession (and then only in Lithuania). But Grasalva could not be included in the accession list, because it was authorised well after the accession list closed on the day that the Treaty of Athens was signed.

160. Presumably, the idea was that manufacturers of products contained in the accession list who wished, after accession, to market their products in any part of the Union (including Lithuania) would, after accession, apply for the appropriate (new) authorisation. In the meantime, they could at least continue to market their products in Lithuania. That would not, however, apply to a product (like Grasalva) that was not, and could not lawfully be placed, on the accession list. Such a product would have to be withdrawn from the market on 1 May 2004. It could only be marketed again once a new authorisation had been obtained (in the case of Grasalva, from the centralised authorities under the Regulation Rules).

161. Dura lex, sed lex.

162. I am conscious also that these are proceedings under Article 226 EC, in which the answer is either that there has been, or that there has not been, an infringement, and which leave little scope for the broader brush approach that is sometimes possible in references for a preliminary ruling. If the problem had come before the Court in the context (for example) of national proceedings involving a private law suit, aspects such as whether the manufacturer of Grasalva could rely on legitimate expectations, or whether the authorisation for Grasalva, delivered in good faith, enjoyed some degree of temporary validity, might have required careful examination. But that is not the case in the present proceedings.

163. I do not find the accession list arrangement, with its complete absence of any mechanism for modification or amendment, at all satisfactory. However, even if I were to go so far as to conclude that the absence of such a mechanism rendered the accession list in some way void or invalid, that would still not suffice. To put it bluntly, the problem is this: in applying precisely the rules that were part of the Union acquis at the relevant time and granting an authorisation for Grasalva that purported to be an authorisation valid for five years in accordance with those rules, Lithuania acting in good faith has nevertheless done something that, as an accession State but not yet a Member State, it was not empowered to do.

164. Accordingly, the Commission is entitled to the declaration that it seeks.

VII – Costs

165. Normally, under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if, as here, the successful party has applied for them. Since the Commission’s application has been upheld, in principle costs should be awarded against Lithuania.

166. However, for the reasons I have given above (particularly the epilogue, where I have questioned the appropriateness of bringing this action), I consider that, if the Court upholds the application, it should take account of ‘circumstances [that] are exceptional’ of the kind referred to in Article 69(3) of the Rules of Procedure, which allow an order that the costs be shared or an order that each party is to bear its own costs. I suggest that the Court make the latter order.

VIII – Conclusion

167. I therefore propose that the Court should:

(1) declare that, by retaining in force after 1 May 2004 the national authorisation for the marketing of the medicinal product Grasalva, Lithuania has failed to comply with its obligations under Article 6(1) of, and Section 4 of Part II of Annex I to, Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Commission Directive 2003/63/EC; and under Article 3(1) of Council Regulation (EEC) No 2309/93 of 22 July 1993 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 and Article 3(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

(2) order each party to bear its own costs.