Opinion of the Advocate General — ECLI:EU:C:2002:86
Date: 2002-02-07
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Free movement of goods;Measures having equivalent effect;Quantitative restrictions
Procedure: Reference for a preliminary ruling
Origin: Germany

summary, both the origin and the composition must be the same. The origin is not at issue in this case. 104. As regards composition, the sameness must derive from the fact that both variants contain the same active ingredients and have the same therapeutic effect. In Rhône-Poulenc Rorer and May & Baker the Court stated that differences in excipients, which affect shelf-life for example, are immaterial. It can be otherwise only if the difference in excipients gives rise to public health problems. 105. In the present case we are concerned with a difference that, although it does not per se cause a change in shelf-life, is otherwise totally comparable. If the old variant is kept at room temperature, it loses its efficacy after a short period of time. The new variant marketed by Ferring includes an undeniable improvement over the old variant. It is an advantage for the consumer not to have to store the nasal spray in a refrigerator. This does not necessarily mean that use of the old variant can give rise to public-health problems. Having regard to the case-law of the Court, I consider that the distinction between the two variants is immaterial and that both variants can be regarded as the same medicinal product for the purposes of the Community rules on the marketing of medicinal products. The (un)desirability of two variants being present side by side on the market 106. According to Ferring, consumers are confused if both variants are on the market side by side. The consequence may be that the old product will be stored at room temperature, which reduces the efficacy of the product. The risk that temperature stable and temperature unstable products would be on the market at the same time was a decisive reason for Ferring in surrendering the implied licence. Eurin-Pharm regards this argument as being principally an excuse to be able to prevent parallel imports. The packaging of the old product always states that it must be kept cool. 107. At the hearing Ferring also pointed out that the risk of confusion ceases as soon as the parallel importer obtains a licence in his own right. From that point in time two different preparations exist marketed under different names. 108. The Commission points out that the question whether the presence of two variants of the same preparation on the market leads to confusion, is not relevant in this case. In the approval system for medicinal products, there is always a risk that two variants of the same product may be marketed. The parallel importer can always submit an application himself on the basis of Directive 65/65. The question raised in this connection does not therefore need to be examined in assessing whether it is permissible to maintain a parallel import licence. 109. Fundamentally, I agree with the Commission's position. The approval system for medicinal products does not exclude the possibility that two variants of the same medicinal product may be marketed, even when that may lead to confusion for the consumer. The consumer is not concerned by the title under which a parallel importer places a medicinal product on the market. When it is imported the parallel import variant - at least in the German system - is assigned the same registration number as the original variant. This registration number is in fact not something that the average consumer will notice. 110. At the hearing Ferring also pointed to the possibility that, should the parallel importer hold a separate authorisation, the variants would be on the market under different names. I do not fully understand this argument. In my opinion the original holder of an MA can give a new variant a new name if he wishes to alert the consumer to a difference with regard to the old variant. In the present case Ferring did this by marketing the new variant under the name Minirin Nasenspray 5 ml. This is nothing to do with the parallel importer. Old variant still available in other Member States 111. In my view the crux of the matter is that the possibility for a medicinal product manufacturer to market different variants of the same medicinal product in the various Member States can result in an unnecessary partitioning of the Member States' markets, (44) which runs counter to the interests of the internal market within the European Union. 112. Barring evidence to the contrary, the fact that the old variant is still marketed in other Member States reinforces the argument that this variant does not present any safety risks and that parallel imports of the old variant continue to be possible. Furthermore, according to Eurin-Pharm, the new product was not available in other countries from which it could have been exported. Eurin-Pharm states, therefore, that it was only able to import the old product into Germany. 113. In short, if a variant of a medicinal product is (still) lawfully marketed in one Member State, then these variants may also be imported into another Member State. It would be otherwise only in the event of exceptional and specific public health circumstances arising in the latter Member State. VIII - Conclusion 114. In light of the foregoing considerations I propose that the Court should reply as follows to the questions from the Landgericht Köln (Regional Court, Cologne): (1) Withdrawal of an MA for the reference medicinal product in the importing country at the request of the licence holder cannot result in the immediate cessation of parallel imports, where the product was not withdrawn in order to protect public health. Such a legal consequence must be regarded as a restriction on imports prohibited under Article 28 EC and for which no justificatory ground is provided for by the Treaty relating, for example, in the present case to public health. Restrictions may be imposed on the parallel importer with a view to supervision of the medicinal product, in so far as those restrictions are directly linked to the safety of the medicinal product or are intended to limit the duration of the right to effect parallel imports. The parallel importer may himself be required to request an MA within a reasonable period of time, or suffer withdrawal of his parallel import licence. The fact that an implied licence is at issue is immaterial to the assessment of the case. (2) In the circumstances of the case the fact that the original licence holder markets a similar medicinal product is immaterial. 1: - Original language: Dutch. 2: - In instances where it clarifies the discussion I shall use the term MA for the authorisation that is granted to the person who places a medicinal product on the market for the first time in a particular Member State. In cases such as the present the term parent-authorisation is also used instead of MA. 3: - OJ 1965 L 22, p. 369. This Directive has been frequently amended. The most important amendments can be found in Council Directive 87/21/EEC of 22 December 1986 amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ 1987 L 15, p. 36) and in Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (OJ 1993 L 214, p. 22). 4: - As amended by Directive 87/21. 5: - As amended by Directive 93/39. 6: - OJ 1975 L 147, p. 13, Article 29a is inserted by Directive 93/39 (cited in footnote 3). 7: - OJ 2001 L 311, p. 67. 8: - Case 104/75 De Peijper [1976] ECR 613. 9: - Case C-201/94 Smith & Nephew Pharmaceuticals and Primecrown v The Medicine Control Agency [1996] ECR I-5819. 10: - Case C-94/98 Rhône-Poulenc Rorer and May & Baker [1999] ECR I-8789. 11: - Law on Medicinal products 1976 (hereinafter: AMG). 12: - Hereinafter: Communication. 13: - Cited in footnote 10. 14: - Cited in footnote 10. 15: - The Commission altered its point of view following fresh appraisals. 16: - The fundamental judgment in this field is the judgment of 14 July 1994, Paola Faccini Dori v Recreb (Case C-91/92 [1994] ECR I-3325, paragraphs 20 and following). Confirmed in, amongst others, the judgment of 26 September 2000 Unilever Italia v Central Food (Case C-443/98 [2000] ECR I-7535). 17: - Cited in footnote 10, paragraph 39 of the judgment. This question has also arisen in the case Paranova Läkemedel and others which is still pending before the Court. 18: - In the remainder of this Opinion I shall refer to the old and new variants of the medicinal product. The use of this term is more correct in view of the problem at issue. 19: - See the fourteenth recital of Directive 2001/83, cited in footnote 10 of this Opinion. 20: - See the fourth recital of Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products, OJ 1975 L 147, p. 1. 21: - Cited in footnote 10, paragraph 23. 22: - See also on this point the fifteenth recital of Directive 2001/83. 23: - See paragraph 25 of the judgment in Rhône-Poulenc Rorer and May & Baker (cited in footnote 10). 24: - Cited in footnote 8, paragraph 21. 25: - Cited in footnote 9, paragraph 21. 26: - See paragraph 25 of the judgment in De Peijper, cited in footnote 8. 27: - See also the Opinion of Advocate General La Pergola in Rhône-Poulenc Rorer and May & Baker (cited in footnote 10, paragraph 6). 28: - Judgment in Rhône-Poulenc Rorer and May & Baker (cited in footnote 10, paragraph 40 and 45). 29: - See the judgment in De Peijper (cited in footnote 8, paragraph 21). 30: - See Commission communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted (OJ 1982 C 115, p. 5). 31: - As introduced by Directive 93/39. 32: - See the De Peijper judgment (cited in footnote 8, paragraphs 27-29). 33: - Cited in footnote 30. 34: - See amongst others the judgment in Smith & Nephew and Primecrown (cited in footnote 9, paragraph 27). 35: - Cited in footnote 8, paragraph 32. 36: - Cited in footnote 9, paragraphs 25 and 26. See also paragraph 28 of the Rhône-Poulenc Rorer and May & Baker case (cited in footnote 10). 37: - Opinion in the Rhône-Poulenc Rorer and May & Baker case (cited in footnote 10, paragraph 27). 38: - These form the main body of a medicinal product, apart from the active ingredient. 39: - See also judgment of 11 March 1999, British Agrochemicals Association (Case C-100/96, ECR I-1499, paragraph 40). This case related to plant protection products. 40: - The meeting referred to was in December 1986, at which Council Directive 87/21/EEC of 22 December 1986 amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (cited in footnote 3), was adopted. 41: - See judgment of 3 December 1998, Generics (UK) and Others (Case C-368/96, ECR I-1967, paragraph 25). 42: - I do not take into consideration the particular circumstance that it is an implied licence that is concerned here. See on this issue paragraphs 31-32 of this Opinion. 43: - Cited in footnote 8. 44: - I refer to the Opinion of Advocate General La Pergola in Rhône-Poulenc Rorer and May & Baker (cited in footnote 10).