Judgment — ECLI:EU:C:2004:208
Date: 2004-04-01
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Free movement of goods;Measures having equivalent effect;Quantitative restrictions
Concepts: Protection of public health and protection of plants
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary of the parties’ arguments 31. Kohlpharma first claims that the criterion of common origin, referred to in the judgments in Smith & Nephew and Primecrown and Rhône-Poulenc Rorer and May & Baker, does not constitute a prerequisite for extending to an imported medicinal product a marketing authorisation already granted for another medicinal product in the State of importation. 32. In fact, in Kohlpharma’s view, the reason why those judgments refer to the common origin of the imported medicinal product and the product already authorised in the State of importation is that there was a common origin in both cases and, therefore, the Court mentioned it merely as an additional argument. 33. Kohlpharma takes the view that that is the only tenable interpretation in the light of the Court’s case-law. If common origin were considered to be a separate and essential condition, a medicinal product which was identical to, but did not have the same origin as, a medicinal product covered by a marketing authorisation in the State of importation could be imported only after it had been subjected to a full new assessment by the competent authority. However, since that authority already has all the data on that medicinal product, Kohlpharma claims that such an assessment is not justified, under Article 30 EC, on grounds of the protection of health and life of humans. (9) 34. In any event, according to Kohlpharma, the concept of common origin, within the meaning of the judgment in Smith & Nephew and Primecrown, should include the situation where, as in this case, two undertakings, which are independent of each other, manufacture a medicinal product on the basis of an active ingredient obtained from the same supplier. 35. Kohlpharma continues by submitting that if the possibility of ‘Movergan’ and ‘Jumex’ having a common origin is ruled out solely because there is a supply agreement between the Chinoin company and the Orion group rather than a licensing agreement, pharmaceutical undertakings would have at their disposal an easy means of partitioning national markets. They would have only to replace licensing agreements concerning the manufacture and marketing of their own medicinal products with mere supply agreements. 36. Kohlpharma goes on to point out that the facts of this case do not differ substantially from those in Smith & Nephew and Primecrown. It notes that, admittedly, in this case, it is only the active ingredient, on the basis of which ‘Movergan’ and ‘Jumex’ are manufactured, which has a common origin. Nevertheless, in Smith & Nephew and Primecrown also, the licensor of the two medicinal products in question had stated that it supplied only the active ingredient to the manufacturer of one of those products and, consequently, it could not ensure that the two medicinal products were identical. (10) 37. The Commission agrees with Kohlpharma that it is necessary to include cases such as the present within the concept of common origin. What really matters is that the two proprietary medicinal products are essentially identical and that any differences are not significant in terms of the products’ safety and efficacy for human health. 38. Lastly, the German Government, which intervened only at the hearing, took the view, referring to the abovementioned judgments in De Peijper and Smith & Nephew and Primecrown and, in particular, paragraphs 24 and 25 of the latter judgment (see point 23 above), that the common origin of the imported medicinal product and the product already authorised in the State of importation constitutes an essential requirement if the former is to be covered by the marketing authorisation granted for the latter. That requirement must be understood as meaning that those medicinal products must be manufactured by undertakings which are part of the same group or by undertakings linked by a licensing agreement with the same licensor. D – Assessment 1. Introduction 39. Before addressing the substance of the question referred, I must first note that Directive 65/65 was repealed, as were the directives which amended it and other directives on medicinal products for human use, by Directive 2001/83. 40. The latter directive, far from amending the substance of the repealed directives, codified them, in the interests of clarity and rationality, by assembling them in a single text. (11) In confirmation of that, Article 128 of Directive 2001/83 provides that ‘[r]eferences to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III’. 41. Consequently, in the light of the foregoing, the principles established by the case-law of the Court with regard to Directive 65/65 must now be understood as referring, mutatis mutandis, to Directive 2001/83. For those reasons, I shall refer below exclusively to the latter directive. 42. That having been established, it is apparent from the considerations of the Oberverwaltungsgericht and from the observations of the parties to the proceedings that, by the question referred for a preliminary ruling, the Court is essentially being asked to clarify two issues concerning parallel imports of medicinal products. 43. The first is whether the competent authority of a Member State may refuse to extend to a proprietary medicinal product imported from another Member State a marketing authorisation already granted in the first State for a proprietary medicinal product solely because those proprietary medicinal products do not have a common origin. 44. The second – discussed principally and at length at the hearing – is whether the parallel importer is required to provide the competent authority of the State of importation with proof that those proprietary medicinal products are essentially identical, or whether he may simply provide evidence to that effect, in the light of which that authority is bound to carry out appropriate investigations before being able to adopt any decision. 45. Although those issues are closely connected, in the interests of setting them out clearly, I shall address them separately. 2. Common origin 46. As regards this issue, I note once again that, under Article 6(1) of Directive 2001/83, no proprietary medicinal product may be placed on the market of a Member State unless it is covered by a marketing authorisation issued by the competent authority of that State in accordance with the conditions laid down by that directive. 47. However, as is apparent from the Court’s case-law, that condition does not necessarily apply to parallel imports of medicinal products between Member States. (12) Indeed, in such cases, the imported proprietary medicinal product may under specific conditions be permitted to benefit in the Member State of importation from the marketing authorisation already granted in that State for another proprietary medicinal product (see point 25 above). 48. That said, however, it remains to be clarified – and this is the crux of the matter – what those conditions are and what their scope is. 49. I note straight away that the parties to the proceedings and the national court appear to have no doubts as regards two of those conditions. 50. The first is that the proprietary medicinal product, which is the subject of parallel importation, must already be covered by a marketing authorisation issued by the competent authorities of the Member State of origin (see also point 21 above). 51. The second is that that proprietary medicinal product, if not identical in all respects to a proprietary medicinal product already authorised in the Member State of importation, should be so similar to the latter that it can be considered to be essentially identical (see also points 24 and 25 above). That is the case, in particular, when those proprietary medicinal products contain, qualitatively and quantitatively, the same active ingredients, have the same pharmaceutical form, (13) are bioequivalents, (14) and do not appear, in the light of scientific knowledge, to differ as regards their safety and efficacy. (15) 52. While Kohlpharma and the Commission consider that those factors are in themselves sufficient to classify the importation of medicinal products as a parallel import falling outside the scope of Directive 2001/83, the German Government maintains that a further condition must be fulfilled. According to that Government, as has been noted, the imported proprietary medicinal product and the product marketed in the Member State of importation must also have a ‘common origin’, that is to say they must be manufactured by companies which are part of the same group of undertakings or by independent companies but on the basis of agreements with the same licensor. 53. In support of its argument, the German Government relies chiefly on the abovementioned case-law of the Court, which, in its view, establishes precisely that condition. 54. I do not share that view. It is certainly true that, in Smith & Nephew and Primecrown, the Court pointed out that the imported proprietary medicinal product and the reference product in the State of importation had a common origin (see point 23 above). 55. That does not mean, however, as Kohlpharma has rightly observed, that the Court considered that factor to be decisive for the purposes of establishing whether the import was a parallel import falling outside the scope of Directive 2001/83. 56. Indeed, on closer examination, it is apparent that, in that judgment, the Court referred to the common origin of the medicinal products above all because that factor was present both in the case it was examining and in the case that resulted in the judgment in De Peijper. This made it simpler for the Court to hold that the principles set out in De Peijper could be extended to Smith & Nephew and Primecrown (see point 23 above). 57. Secondly, the Court referred to that factor because the common origin of the imported medicinal product and of the ‘national’ product is at any rate a reliable indication that the two products are essentially identical, a fact which the parallel importer may rely on before the competent authority of the Member State of importation in order to avoid application of Directive 2001/83 (see point 82 below). 58. However, the fact that common origin does not constitute an essential requirement for the purposes of the present case is, in my view, also apparent from the very wording of the judgment in Smith & Nephew and Primecrown. In paragraphs 21 to 24 of that judgment, after stating that ‘the provisions of Directive [2001/83] concerning the procedure for issue of marketing authorisations cannot apply’ to a case such as that examined in De Peijper, where the proprietary medicinal product which was the subject of a parallel import ‘was in every respect the same’ (16) as the reference proprietary medicinal product in the State of importation (paragraphs 21 to 23), the Court added that ‘[m]oreover, the proprietary medicinal products at issue in that judgment had been manufactured by the same group of companies and therefore had a common origin’ (17) (paragraph 24). 59. It seems to me that that wording, in particular the use of the word ‘moreover’, supports the view that common origin is a factor which, while certainly being important, is none the less supplementary and additional to the – decisive – factor of the identical or essentially identical nature of the products. 60. In my view, similar considerations apply also in relation to paragraph 28 of the judgment in Rhône-Poulenc Rorer and May & Baker already cited (see point 27 above), which could equally be interpreted as proving that the Court considers the decisive condition to be the common origin of the imported medicinal product and the product already marketed in the State of importation. 61. In actual fact, it seems to me that that passage has a different meaning. In it, as Kohlpharma has observed, the Court merely refers to Smith & Nephew and Primecrown in order to be able to state immediately afterwards (in paragraph 29) that some of the factors which led to that judgment were also present in the case at issue. The Court thus avoided having to examine the consequences which would have arisen were some of those factors not present, including specifically the common origin of the medicinal products in question. 62. For the reasons set out above, I do not, therefore, consider that the Court’s case-law lays down the condition at issue, unequivocally and unambiguously, and, consequently, that condition cannot conclusively be relied on in support of the German Government’s view. 63. However, in my opinion, there are arguments which counter that view and which can be inferred from the exact same case-law of the Court to which considerable reference is made here. 64. As already mentioned, that case-law places considerable emphasis on the fact that the primary purpose of Directive 2001/83 is ‘to ensure that, when a proprietary medicinal product is marketed, public health is safeguarded by means which cannot hinder the development of the pharmaceutical industry or trade in medicinal products within the Community’. (18) 65. Therefore, what is above all clear from that case-law is that the principal aim of the relevant Community legislation is to safeguard public health. Indeed, that is why the production of all the documents and all the information necessary for the granting of a marketing authorisation is justified ‘only in regard to proprietary medicinal products which are being put on the market for the first time’ (paragraphs 19 and 20 of the judgment in Smith & Nephew and Primecrown), just as parallel imported proprietary medicinal products may be placed on the market in a Member State without being subject to the requirements laid down by that legislation only where those products do not pose any risk to human health and life (see points 23 and 24 above). 66. However, if the main criterion must be the protection of public health, I do not believe that common origin can play a decisive role in this case. 67. On the one hand, in my view, the fact that a proprietary medicinal product has already been authorised in the Member State of exportation and, above all, that it is identical or essentially identical, as defined above (see point 51), to a proprietary medicinal product which is itself also authorised in the Member State of importation, can be considered quite sufficient to rule out the possibility that the placing on the market of the Member State of importation entails a risk for public health. 68. On the other hand, even if the imported proprietary medicinal product and the product authorised in the State of importation have a ‘common origin’, in my view, that is not in itself sufficient to rule out the possibility of risks for public health. Indeed, it is conceivable that, even though they have a common origin, the imported proprietary medicinal product and the product authorised in the Member State of importation may be manufactured using different substances or different processes and that, therefore, the first may differ from the second not only in terms of its therapeutic properties but also in terms of safety for human health. 69. I would add that, in my opinion, the other requirement highlighted by the Court’s case-law, that is to say the requirement not to hinder ‘the development of the pharmaceutical industry or trade in medicinal products within the Community’ (see point 20 above), is also better safeguarded by the premiss which does not require the condition of common origin. Further, more generally, that premiss is clearly more consistent with the principles of the free movement of goods, as well as with the second and third recitals in the preamble to Directive 2001/83, which specifically enunciate those principles. (19) 70. Since the conditions laid down by Directive 2001/83 for the granting of a marketing authorisation represent potential obstacles to the free movement of medicinal products between Member States, within the meaning of Article 28 EC, such obstacles can be justified under Article 30 EC only in so far as they are intended to safeguard public health. 71. However, since public health can be considered to be safeguarded where the two conditions referred to above are fulfilled (see points 50 and 51 above), the requirement that the additional condition of common origin be fulfilled would constitute an unjustified restriction on the free movement of the products in question. 72. Consequently, it seems to me that the conclusion can be drawn, with regard to this case, that the fact that the two proprietary medicinal products in question have been manufactured on the basis of a licensing agreement or a supply agreement with the same undertaking cannot be regarded as crucial when it comes to placing on the market the medicinal product which is the subject of a parallel import into the Federal Republic of Germany. 73. In the light of the foregoing considerations, I therefore propose that the question referred for a preliminary ruling should be answered to the effect that Article 28 EC precludes a national authority from obstructing the parallel importation of a proprietary medicinal product which is covered by a marketing authorisation in the Member State of exportation and which, although it is not identical to a proprietary medicinal product authorised in the Member State of importation and does not have a common origin with that product, contains, qualitatively and quantitatively, the same active ingredients, has the same pharmaceutical form, is bioequivalent and does not appear, in the light of scientific knowledge, to present significant differences as regards safety and efficacy. 3. The burden of proof 74. That having been established, it remains to be clarified, in relation to the discussion which took place at the hearing in this connection, whether it is for the importer to provide the proof that the products in question are essentially identical, or whether, where there is sufficient evidence in that regard, it is for the competent authority of the State of importation to carry out any investigations necessary before it can adopt a decision on the application for the marketing authorisation to be extended to the imported proprietary medicinal product. 75. Kohlpharma favours the latter theory. It is of the opinion that the judgments in De Peijper and Smith & Nephew and Primecrown indicate that the authority of the State of importation can refuse to allow the imported medicinal product to be covered by the marketing authorisation already granted for the other product only if, using all the means at its disposal and, if necessary, in consultation with the competent authorities of the State of exportation, it ascertains – or at least cannot rule out the possibility – that the two medicinal products do not have the same therapeutic effects or are not equally harmless for human health. 76. The Commission and the German Government, however, contend that in principle it is incumbent on the importer to prove to the competent authority that all the conditions for allowing a medicinal product imported from a Member State to be covered, in the Member State of importation, by the marketing authorisation already granted for another medicinal product have been fulfilled. More specifically, if, as in this case, the imported medicinal product and the product already authorised in the State of importation contain different excipients, the importer is subject to a burden of proof similar to that incumbent on manufacturers – such as, for example, manufacturers of generic medicinal products – wishing to rely on the procedure laid down in Article 10 of Directive 2001/83, that is to say the duty to prove by means of bioavailability studies that the medicinal products which they intend to place on the market are bioequivalent to medicinal products already on that market. 77. Moreover, according to the Commission, the slighter the degree of common origin between two medicinal products, that is to say the weaker the link between the holders of the marketing authorisations issued for those medicinal products in the two Member States, the greater should be the burden on the importer to prove that those medicinal products are so similar that, in the event of the importation of one of those products into one or other of those States, the application of Directive 2001/83 would not be justified. 78. For my part, I should first point out that the alleged similarity between a parallel importer and a manufacturer of generic medicinal products seems to me to be questionable. The former simply purchases a medicinal product, which, given that it is on the market in the Member State of origin, is already covered by a marketing authorisation granted by the competent authority of that State, in order to place it on the market of another Member State where an identical, or essentially identical, proprietary medicinal product is marketed at a higher price. As a mere importer, he does not usually have all the data concerning the efficacy and safety of the imported medicinal product, but that data has presumably already been supplied to the competent authority of the State of exportation by the holder of the marketing authorisation in that State. 79. In principle, however, a manufacturer of generic medicinal products places on the market of one or more Member States medicinal products which are not yet covered by a marketing authorisation in any Member State, and, consequently, he alone possesses information on their safety and efficacy. It therefore seems clear to me that such a manufacturer should be required to fulfil all the conditions laid down by Directive 2001/83 where he seeks to avail himself of the abridged procedure provided for by Article 10 of that directive. (20) 80. In my view, however, that same obligation can be placed on a parallel importer only within the limits which I shall attempt to define below. 81. Firstly, it should be borne in mind that considerable evidence with regard to the lack of significant differences, in terms of safety and efficacy, between the imported proprietary medicinal product and the reference product in the State of importation can be found in the package leaflets of those proprietary medicinal products. Under Article 59 of Directive 2001/83, those leaflets should include: a full statement of the active substances and excipients of the medicinal product expressed qualitatively, a statement of its active substances expressed quantitatively, the pharmaceutical form, the therapeutic indications, the information necessary for taking it (contra-indications, precautions for use and special warnings), the dosage, the method and frequency of administration and the undesirable effects. 82. Secondly, in addition to that evidence, the parallel importer can, if necessary, provide other useful information to the competent authority. He can, for example, demonstrate that the proprietary medicinal products in question are sold under the same name in the two States concerned, or that they have a common origin in that they are manufactured by undertakings belonging to the same group or on the basis of licensing agreements with the same licensor, or that, as in this case, their active ingredient is identical and is obtained from the same undertaking. 83. In other words, the parallel importer must provide, on request, all useful information in his possession or accessible to him. However, in my view, any additional information necessary to establish the safety and efficacy of the imported proprietary medicinal product should be sought first and foremost by the competent authority of the Member State of importation using, as Kohlpharma points out, all the means at its disposal and, in particular, in consultation with the competent authority of the Member State of exportation. (21) 84. In this connection, I note that, according to the Court’s case-law: ‘even if it were absolutely necessary to require the parallel importer to prove this conformity, there would in any case be no justification under Article [30 EC] for compelling him to do so with the help of documents to which he does not have access, when the administration, or as the case may be, the court, finds that the evidence can be produced by other means’. (22) 85. That is true also because, again according to the Court, ‘simple cooperation between the authorities of the Member States would enable them to obtain the necessary substantiating documents on a reciprocal basis’ regarding the safety and efficacy of the imported medicinal product. (23) 86. In those circumstances, therefore, and in the light also of the principles of the free movement of goods, it is my view that, if there is reliable evidence to show that there are no significant differences between a proprietary medicinal product imported from a Member State, where it is covered by a marketing authorisation, and a proprietary medicinal product which is covered by a marketing authorisation in the Member State of importation, the competent authority of the latter State may not refuse an application to extend to the former proprietary medicinal product the marketing authorisation granted for the latter simply by raising possible doubts as to the efficacy and safety of the imported proprietary medicinal product. 87. If it has such doubts, that authority must first of all avail itself of all means at its disposal to seek to obtain additional information, consulting in particular the competent authority of the Member State of exportation. 88. If, having carried out the appropriate investigations, doubts persist as to the safety and efficacy of the proprietary medicinal product in question, only then can that authority require the importer to provide proof capable of dispelling those doubts and thus avoiding the marketing of the imported proprietary medicinal product being made subject to the conditions laid down by Directive 2001/83. 89. In the light of the foregoing considerations, I therefore propose that the answer to the national court should be that where, despite information provided by the importer, serious doubts persist as to the lack of significant differences between a proprietary medicinal product imported from a Member State, in which it is lawfully marketed under a marketing authorisation issued by the competent authority of that State, and a proprietary medicinal product placed on the market in the Member State of importation, the competent authority of the latter State can require that the imported proprietary medicinal product be placed on the market subject to full compliance with the conditions laid down by Directive 2001/83 only after it has itself carried out all the appropriate investigations, including consultation with the competent authorities of the Member State of exportation. V – Conclusion 90. In the light of the foregoing considerations, I therefore propose that the Court reply to the question raised by the Oberverwaltungsgericht as follows: (1) Article 28 EC precludes a national authority from obstructing the parallel importation of a proprietary medicinal product which is covered by a marketing authorisation in the Member State of exportation and which, although it is not identical to a proprietary medicinal product authorised in the Member State of importation and does not have a common origin with that product, contains, qualitatively and quantitatively, the same active ingredients, has the same pharmaceutical form, is bioequivalent and does not appear, in the light of scientific knowledge, to present significant differences as regards safety and efficacy. (2) Where, despite information provided by the importer, serious doubts persist as to the lack of significant differences between a proprietary medicinal product imported from a Member State, in which it is lawfully marketed under a marketing authorisation issued by the competent authority of that State, and a proprietary medicinal product placed on the market in the Member State of importation, the competent authority of the latter State can require that the imported proprietary medicinal product be placed on the market subject to full compliance with the conditions laid down by Directive 2001/83 only after it has itself carried out all the appropriate investigations, including consultation with the competent authorities of the Member State of exportation. 1 – Original language: Italian. 2 – Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20). 3 – 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 (OJ 2001 L 311, p. 67). See in particular Article 128 of that directive. 4 – 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 (OJ 1993 L 214, p. 1). 5 – Case C-201/94 Smith & Nephew and Primecrown [1996] ECR I‑5819. 6 – Case C-94/98 Rhône-Poulenc Rorer and May & Baker [1999] ECR I-8789. 7 – Case 104/75 De Peijper [1976] ECR 613. 8 – Opinion of Advocate General Geelhoed in Case C-172/00 Ferring Arzneimittel [2002] ECR I‑6891, points 37 to 40. 9 – In support of that argument, Kohlpharma refers to the Opinion of Advocate General Geelhoed in Case C-172/00 Ferring Arzneimittel, cited above, points 37 to 40. 10 – See the judgment in Smith & Nephew and Primecrown, cited above, paragraphs 11 and 14. 11 – See the first recital in the preamble to Directive 2001/83. 12 – See the judgment in Smith & Nephew and Primecrown, paragraphs 19 and 20, cited above in points 20 and 21. To the same effect, see the Opinion of 12 December 2003 delivered by Advocate General Jacobs in Case C‑15/01 Paranova Läkemedel [2003] ECR I-4175, paragraph 6, where there are further references. 13 – The pharmaceutical form of a medicinal product means the form in which it is presented (capsules, drops to be taken orally in solution, injections and so on) and the form in which it is administered (orally, rectally, nasally, cutaneously and so on). On this subject, see point 37 of the Opinion of Advocate General Ruiz-Jarabo Colomer in Case C-368/96 Generics (UK) and Others [1998] ECR I-7967. 14 – ‘[T]wo medicinal products are bioequivalents if they are pharmaceutical equivalents or alternatives and if their bioavailabilities (rate and extent) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, will be essentially the same’ (judgment in Generics, cited above, paragraph 31). 15 – See, in this regard, the judgment in Generics, cited above, paragraph 36. 16 – Emphasis added. 17 – Emphasis added. 18 – Judgment in Smith & Nephew and Primecrown, cited above, paragraph 19. To the same effect, see judgment in Generics, cited above, paragraph 22. 19 – Those recitals state: ‘[t]he essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health … by means which will not hinder [the free movement of] medicinal products within the Community’. 20 – If, however, a manufacturer of generic medicinal products intends to place on the market of a Member State a medicinal product for which he has already obtained a marketing authorisation in another Member State, he may avail himself of the procedure on the mutual recognition of marketing authorisations provided for by Chapter 4 of Directive 2001/83. 21 – I am thinking, for example, of any bioavailability studies that might have been submitted to that authority. Section E [under Part 4] of Annex I to Directive 2001/83 provides that ‘[t]he assessment of bioavailability must be undertaken in all cases where it is necessary, e.g. where the therapeutic dose is near the toxic dose or where the previous tests have revealed anomalies which may be related to pharmacodynamic properties, such as variable absorption’. 22 – Judgment in De Peijper, cited above, paragraph 29. 23 – Judgment in Smith & Nephew and Primecrown, cited above, paragraph 28.