C-172/00

FERRING

O P I N I O N O F ADVOCATE GENERAL GEELHOED delivered on 7 February 2002 1

I — Introduction licence. The question therefore also arises as to whether this implied licence can be regarded as being an MA.

1. In the present case the Landgericht Köln (Regional Court, Cologne (First Commer- cial Chamber)) has referred four questions concerning the interpretation of Articles 28 and 30 EC in the matter of parallel imports of medicinal products. II — Legal background

2. Essentially the questions relate to the situation where the marketing authori- European Law sation (hereinafter: 'MA') 2 for a medicinal product has been withdrawn at the request of the licence holder because he no longer markets the product. Instead he markets a similar product. The point at issue is there- 3. Parallel imports of medicinal products fore whether it is compatible with are to a large degree governed by Articles 28 Articles 28 and 30 EC for parallel imports and 30 EC. Furthermore, the marketing of of the old preparation, from another medicinal products is regulated by a Member State — by someone other than number of Community Directives. the former licence holder — to be pro- hibited. A particular circumstance in this case is that the old preparation was mar- keted on the basis of a so-called implied

1 — Original language: Dutch. 2 — In instances where it clarifies the discussion I shall use the 4. According to Article 3 of Council Direc- term MA for the authorisation that is granted to the person who places a medicinal product on the market for the first tive 65/65/EEC of 26 January 1965 on the time in a particular Member State. In cases such as the approximation of provisions laid down by present the term 'parent-authorisation' is also used instead of MA. law, regulation or administrative action

5. The second paragraph of Article 4 of (ii) or by detailed references to published Directive 65/65 provides an overview of the scientific literature... that the consti- particulars and documents that should tuent or constituents of the proprietary accompany the application for an MA. medicinal product have a well estab- Among other things, this concerns quali- lished medicinal use, with recognised tative and quantitative particulars of all the efficacy and an acceptable level of constituents of the proprietary product safety; (point 3), results of the physio-chemical, biological or microbiological tests and of the pharmacological and toxicological tests and clinical trials (point 8) and one or more (iii) or that the proprietary medicinal prod- specimens or mock-ups of the sales presen- uct is essentially similar to a product tation of the proprietary product (point 9). which has been authorised within the Community, in accordance with Com- munity provisions in force, for not less 3 — OJ 1965 L 22, p. 369. This Directive has been frequently amended. The most important amendments can be found in than six years and is marketed in the Council Directive 87/21/EEC of 22 December 1986 amend- Member State for which the appli- ing Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action cation is made...'. 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.

However, this objective must be attained 9. Under Article 29a of the Second Council by means which will not hinder the deve- Directive 75/319/EEC of 20 May 1975 on lopment of the pharmaceutical industry or the approximation of provisions laid down trade in medicinal products within the by Law, Regulation or Administrative Community.' action relating to proprietary medicinal 6 — OJ 1975 L 147, p. 13, Article 29a is inserted by Directive 93/39 (cited in footnote 3). 5 — As amended by Directive 93/39. 7 —OJ 2001 L 311, p. 67.

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There is, as is apparent from the fourth 12. The basis in European law for the whereas, a direct link with the functioning implied licence is to be found in of the internal market. In this connection Article 39(2) of the Second Directive. the fourteenth whereas states that: 'This Directive represents an important step towards achievement of the objective of the free movement of medicinal prod- ucts....'

National Law

11. The present case concerns parallel imports of medicinal products. The Court has marked out this area in three important cases. These cases are: 13. According to Article 105 of the Arz- neimittelgesetz 1 1medicinal products may be marketed in Germany without an MA providing they were already on the market on 1 January 1978 when the Law came into force. Marketing takes place on the — the De Peijper Case of 20 May 1976; 8 basis of a so-called implied licence consist- ing of a declaration from the competent authorities. These medicinal products were entitled to remain on the market as long as a request for renewal of the implied licence was made before 30 March 1990. — the Smith & Nephew and Primecrown Case of 12 November 1996; 9

17. The parties to the main proceedings, Ferring Arzneimittel GmbH (hereafter: 'Ferring') and Eurin-Pharm Arzneimittel GmbH (hereafter: 'Eurin-Pharm') are com- petitors in the marketing of medicinal products. 15. According to a Communication of 17 April 1996 from the Bundesinstitut für Arzneimittel und Medizinprodukte 12 (Fed- eral Institute for Pharmaceutical and Medicinal Products) parallel importers 18. The main proceedings concern the have a right to market medicinal products importation into Germany by Eurin-Pharm following a notification to the competent of the medicinal product Minirin Spray. authorities, if the medicinal products in Since June 1996 Eurin-Pharm has been question were already on the market on the importing this preparation from elsewhere basis of an implied licence. In such cases in the European Union and placing it on the there is no verification of the identity of the market in Germany with German labelling medicinal products. with the registration number 10545. The preparation in question was first marketed under this number by Ferring, without an MA, because it was already on the market on 1 January 1978. In accordance with Paragraph 105 of the AMG Ferring had received an implied licence for the medici- nal product. In a letter to the Bundesinstitut für Arzneimittel und Medizinprodukte 16. The communication also states that, (Federal Institute for Pharmaceutical and according to German administrative prac- Medicinal Products) dated 14 July 1999 tice, parallel imports remain authorised in Ferring surrendered the implied licence. the event of the extension of an implied Ferring now markets the product Minirin licence, in so far as the imported medicinal Nasenspray 5 ml on the basis of a new products are identical to the product to licence with the number 32187.00.00. This which the implied licence relates. This medicinal product has supplanted the applies until the procedure for extending Minirin Spray preparation. the implied licence is terminated and until the medicinal product imported as a paral- lel import has obtained its own licence.

21. Eurin-Pharm also contends that the two-year clearance time-limit under ' 1 . Do Articles 28 EC and 30 EC preclude Paragraph 31 (IV) of the AMG is appli- national law which prohibits the mar- cable, although that is not strictly provided keting of medicinal product X, for by the letter of the law. Any other interpretation of this provision would run counter to the free movement of goods 13 — Cited in footnote 10.

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FERRING

— for which there existed hitherto in the marketability of the medicinal product Member State A an implied licence was preserved for a certain (transitional) which has now expired because the period? licence holder has surrendered it,

— which for several years has been If yes, according to which criteria must the brought as a parallel import from previous holder, when taking a decision on Member State B to Member State A his action, take into consideration the and has been placed on the market European free movement of goods? there with reference to the abovemen- tioned implied licence,

3. Does it affect the judgment if medicinal product Y in the new formulation is placed — which the manufacturer and licence on the market only in Member State A or if holder is replacing with a new prep- it is also found on the market in other aration Y [which it] is placing on the Member States? market in Member State A on the basis of an independent licence,

decision the Landgericht Cologne stated 'tie into' existing licences, including implied that national legislation was clear and that licences. If, however, there is no licence, Eurin-Pharm's interpretation should be then an importer cannot 'tie into' it. There rejected. In accordance with Paragraph 105 is no perceptible restraint of trade, if only of the AMG the two-year clearance time- because it was submitted without contra- limit (ex Paragraph 31 (IV) of the AMG) diction at the hearing that Eurin-Pharm does not apply to the surrender of an could obtain a licence itself within 90 days, implied licence. Ferring could indeed have under the simplified authorisation pro- withdrawn the application to extend the cedure. implied licence with the result that it would have remained valid until the end of 2004. However, the referring court considers that Ferring was not obliged by law to take this step; nor did any other obligation exist compelling a licence holder to take into consideration the interests of a parallel 27. The Landgericht is, however, not cer- importer. tain with regard to this interpretation of European law. Whatever the case may be in this respect, Eurin-Pharm cannot, at any rate, rely upon the judgment in the Rhône- Poulenc Rorer and May & Baker. 14 In that decision the particular problem of the lack of an MA was expressly left open. 25. In any event, the new medicinal prod- uct is distinct from the old medicinal product in regard to its temperature stabil- ity. This difference can also have an impact on the application of the medicinal prod- uct. The Landgericht Cologne indicates that the situation could arise where a patient is in possession of both prepara- tions and uses them one after the other and The proceedings before the Court thus fails to pay heed to the correct temperature. Thus, there are material dif- ferences from a therapeutic point of view between the old and the new preparations. 28. The parties to the main proceedings, Ferring and Eurin-Pharm, and the Com- mission submitted written observations. They expounded their arguments at the hearing of 22 November. 15 The Swedish Government also made observations at this 26. According to the Landgericht Cologne hearing. considerations of European law cannot entail a result favourable to Eurin-Pharm. 14 — Cited in footnote 10. The MA is tied to the product, which 15 — The Commission altered its point of view following fresh makes it possible for parallel importers to appraisals.

32. In my view the Commission raises a relevant point in this connection. At the very least, there are doubts concerning the question whether the implied licence could 30. On its own merits I agree with Ferring's still serve as the basis for marketing view regarding the scope of the proceed- medicinal products after 21 May 1990. ings. Nevertheless, the additional con- Nevertheless, I am of the view that the sequences of the withdrawal of the MA compatibility or otherwise with European on the parallel importer must be taken into law of the legal concept of the implied account. That is a question concerning the licence should not be of primordial import- obligations which can be imposed on the ance in the Court's reply. Firstly, the parties in order to limit the effects of referring court does not pose this question. withdrawal. Secondly — and I consider this to be of greater importance — the Commission's point of view essentially relates to the doctrine of the direct effect of directives in the event of incorrect transposition. According to the settled case-law of the Court a directive cannot of itself impose 31. A second preliminary remark relates to obligations on an individual and cannot the German system, and in particular therefore be relied upon as such against an implied licences. At the hearing the Com- individual. 16 In the present case, therefore, mission representative raised the issue of the compatibility of the German legislation with European law. In the Commission's 16 — The fundamental judgment in this field is the judgment of view, as from 21 May 1990, implied 14 July 1994, Paola Faccini Dori v Recreb (Case C-91/92 [1994] ECR I-3325, paragraphs 20 and following). Con- licences could no longer serve as the basis firmed in, amongst others, the judgment of 26 September 2000 Unilever Italia v Central Food (Case C-443/98 for lawful marketing. The Commission [2000] ECR I-7535).

35. Finally I shall examine the fact that Ferring has introduced a new variant 18 of 33. This brings me to the questions posed the medicinal product on to the market. I by the referring court. In essence the shall conclude that it is irrelevant that the referring court seeks to ascertain whether licence holder replaces the old variant by a Articles 28 and 30 EC preclude national new variant. However, the following ques- legislation whose consequence is that, in tions must still be addressed: the event of the withdrawal of an MA at the request of the licence holder, parallel imports also cease to be permitted. This is in my view the nub of the present proceed- ings. In the event of an affirmative reply to this question, I must then consider the conditions that can be imposed on the parallel importer, who markets a medicinal — Can a variant of a medicinal product product for which the original MA has be described as new when the prepara- been withdrawn. Thereafter, I shall con- tion concerned has the same thera- sider two particular aspects of the present peutic efficacy, but differs from the old proceedings. The first is the question variant in the manner in which it must whether the licence holder, who requests be stored? its withdrawal, must take into account the interests of the parallel importer. The second aspect, already mentioned in the previous paragraph hereof, is that we are dealing here with an implied licence.

— Is it undesirable that the old and new variants be available simultaneously on the market?

34. It should be noted that the main issue in the present case was already raised in the 17 — Cited in footnote 10, paragraph 39 of the judgment. This question has also arisen in the case Paranova Läkemedel Rhône-Poulenc Rorer and May & Baker and others which is still pending before the Court. case. That case was more concerned with 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 the question of the lawfulness, as regards is more correct in view of the problem at issue.

Scope and content of the marketing auth- 38. For reasons of public health it is orisation necessary for all medicinal products to have been duly tested before being placed on the market. This is the main provision of Directive 65/65, which the Court has con- firmed in the Rhône-Poulenc Rorer and 36. Community involvement with the mar- May & Baker judgment. 21 No medicinal keting of medicinal products dates back to product may be placed on the market in a 1965. Directive 65/65 harmonised the Member State unless an MA has been national rules in this area. The Community issued under the Directive by the competent system has been progressively extended. authority of that State. An application for a The last substantial expansion was under marketing authorisation for a medicinal Directive 93/39. According to the preamble of Directive 65/65 the safeguarding of public health is paramount. However, this 19 — See the fourteenth recital of Directive 2001/83, cited in footnote 10 of this Opinion. objective must be attained by means that 20 — See the fourth recital of Council Directive 75/318/EEC of will not hinder the development of the 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxico- pharmaceutical industry or trade in medici- logical and clinical standards and protocols in respect of the testing of proprietary medicinal products, OJ 1975 nal products. With the extension of the L 147, p. 1. system, the free movement of medicinal 21 — Cited in footnote 10, paragraph 23.

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I - 6904

FERRING

cannot be regarded as being placed on the 44. Furthermore, parallel imports of market for the first time in the Member medicinal products mainly occur in the State of importation.' interests of the internal market. The exist- ence of parallel imports prevents an unnecessary partitioning of the Member State's markets and ensures that the system of MA's does not lead to certain traders in medicinal products having a monopoly. On the contrary, parallel imports guarantee keen price competition as between econ- omic operators. 27 42. Parallel imports are governed by Articles 28 and 30 EC. A restriction on imports of medicinal products can be based on the protection of public health, but must always be necessary and proportionate. In this regard I would refer once again to the division of powers between the Union and the Member States in the field of public 45. In short, both the wording and the health. In accordance with Article 152(1) objectives of the EC Treaty regard parallel EC, Community action complements imports of medicinal products as a desir- national policy. In the event of no Com- able phenomenon. munity action, the Member States are free to decide their own policy, as long as this remains within the limits of the Treaty (in this case Articles 28 and 30 EC in par- ticular).

48. Within these limits many of the Member States have a simplified authori- sation procedure based on national law. The Commission has published guidelines for the Member States and the economic 50. An important issue for which the operators concerned. 30 According to these licence holder is responsible is the phar- guidelines the simplified procedure must macovigilance system set out in Chapter V result in the granting of an authorisation of the Second Directive. 31 Article 29a pro- within 45 days of the arrival of the vides that this system is to be used to collect application and accompanying documents. information useful for the surveillance of medicinal products, with particular refer- ence to adverse reactions in human beings, and to evaluate such information scientifi- cally. One of the obligations of the licence holder is to report to the competent auth- orities all suspected serious adverse reac- tions that are brought to his attention by doctors. Obligations of the licence holder and the parallel importer and their interrelationship

51. I shall not dwell on all the obligations 49. The legislation on the marketing of vested in the licence holder. The present medicinal products is not solely concerned case is not directly concerned with this with market authorisation. Rules are also matter. I shall restrict myself to two laid down concerning the marketing of important considerations, which are in my view instrumental in the imposition of the obligations. Firstly, the safety of the 29 — See the judgment in De Peijper (cited in footnote 8, medicinal product itself: within a system paragraph 21). 30 — See Commission communication on parallel imports of proprietary medicinal products for which marketing auth- orisations have already been granted (OJ 1982 C 115, p. 5). 31 — As introduced by Directive 93/39.

55. With regard to pharmacovigilance, the 52. It is possible that the authorisation Court adopted the following position in must be suspended or withdrawn. The Rhône-Poulenc Rorer and May & Baker. licence holder may also modify the medici- Pharmacovigilance, satisfying the relevant nal product himself. Article 9a of the requirements of the Second Directive, can Directive may even oblige him to do so in be ensured for medicinal products imported some instances. as parallel imports through cooperation with the national authorities of the other Member States. The authorities of a Member State, where the old version is still marketed on the basis of a valid MA, must grant access to the documents and data relating to this version, produced by the manufacturer or other companies in the 53. In the event of parallel imports certain same group. obligations are also incumbent on the parallel importer. The obligations are not as far-reaching as those of the licence holder in view of the fact that the parallel 56. Cooperation between the national importer cannot be held responsible for the authorities can also remove many of the further development of the medicinal prod- risks for public health in other instances. In uct. Furthermore, the parallel importer its 1982 guidelines 33 the Commission does not have at his disposal all the phar- maceutical particulars relating to the medicinal product. Naturally, this situation 32 — See the De Peijper judgment (cited in footnote 8, must not be allowed to pose a public health paragraphs 27-29). risk. 33 — Cited in footnote 30.

57. Finally, I would refer to an obligation of a totally different nature, which affects 59. In Smith & Nephew and Primecrown the relationship between the licence holder the Court clarified the circumstances invol- and the parallel importer. The licence ving parallel imports of the same medicinal holder is obliged to cooperate with the product. 36 The Court established two competent authorities of the Member State requirements: where the parallel importation occurs. This authority has legislative and administrative means at its disposal, capable of compelling the manufacturer, his duly appointed rep- resentative or the licence holder to supply information in their possession, which the — the medicinal products must have a authority considers to be necessary. 34 common origin by virtue of the fact Thus, anyone holding an MA in the that they are both manufactured pur- importing Member State for a new variant suant to agreements concluded with the of a medicinal product, but belonging to same licensor. It must be avoided that the group that holds an MA for the old the behaviour of the licensor could lead variant in the other Member States, is to partitioning of the national markets obliged to supply any necessary infor- of the various Member States. mation regarding the old variant. The Court has previously ruled in the De Peijper judgment that a rule which makes it possible for a manufacturer to refuse to produce the information necessary to evaluate a medicinal product for the pur- poses of a parallel import licence, must be — The medicinal products must have the regarded as being a measure of equivalent same composition. They do not have to effect, not justified by Article 30 EC. 35 be identical in all respects, however, they must have been manufactured

according to the same formulation, same medicinal product, with the same using the same active ingredient and active ingredients and the same therapeutic they must also have the same thera- effect. The variants were only distinguish- peutic effects. able from each other by differences in the excipients, 38 which had possible con- sequences on the shelf life and the bioa- vailability of the product, for example with regard to the speed at which the medicinal product dissolved or was absorbed. Such differences are not relevant in answering the question of whether the simplified 60. The second requirement is also associ- procedure for parallel imports (which is ated with the risk that the manufacturer based upon Articles 28 and 30 EC) may be may partition markets by making small applied, provided that the variant imported changes, of no therapeutic relevance, to the as a parallel import does not pose any products that he markets in the various problems as regards its quality, efficacy and Member States. According to Advocate safety. As I understand the Court's case- General La Pergola, if different variants of law, these problems must be related to the the same medicinal product are on the excipients contained in this variant. 39 market, then the manufacturer must be able to demonstrate, to the full satisfaction of the competent national authority, that the difference in formulation is a response to genuine and objective public health con- cerns. The Advocate General then refers to the situation where a version withdrawn from the market in one Member State, is 62. Finally, the Court's interpretation of nevertheless still being manufactured and the notion 'essentially similar proprietary marketed by the same firm, or by a medicinal product' is of importance; in company in the same group, in other accordance with point 8 of Article 4 of Member States. Convincing reasons must Directive 65/65 an abridged procedure is be given in such a situation, including an possible for these products. The Court explanation of why public health concerns refers to the minutes of a Council meet- do not arise in relation to the countries ing. 40 These apply the following criteria: where the old version is still marketed. the same qualitative and quantitative com- Other factors may also play a role. 37 position in terms of active principles and the same pharmaceutical form, and, where necessary, bioequivalence of the two

65. With regard to the permissibility of The main point: the admissibility of an parallel imports Ferring is of the view that import ban with the withdrawal of the (implied) licence, the legal basis for the marketing of the old products ceases to subsist. Eurin- Pharm should therefore have requested a new licence for parallel imports, whereby it 63. In essence the referring court is con- could have referred to the new MA. In the cerned with the admissibility of a ban on ensuing simplified procedure, the national parallel imports of a medicinal product, authority should have verified whether when the MA in the importing country for there was a difference in therapeutic effect the reference product has been withdrawn between the old product and the new at the request of the licence holder. Under product. In the intervening period, that is the applicable German law, the withdrawal to say prior to the decision of the national of the MA at the request of the holder leads authority, the medicinal product may not to the immediate expiry of the licence be marketed.

42 — I do not take into consideration the particular circum- 41 — See judgment of 3 December 1998, Generics (UK) and stance that it is an implied licence that is concerned here. Others (Case C-368/96, ECR I-7967, paragraph 25). See on this issue paragraphs 31-32 of this Opinion.

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FERRING

66. Eurin-Pharm maintains, on the nothing to do with product safety, or more contrary, that the old product may at least generally with public health interests. remain on the market during a transitional Withdrawal is a direct result of the fact period. Eurin-Pharm considers it to be that the manufacturer no longer markets important that this situation should not the product concerned in the Member State endanger pharmacovigilance. The German in question. The basis for the decision is authorities still have at their disposal all the quite simply the request of the licence information submitted in the course of the holder, which is itself linked to the licence various authorisation procedures. Fur- holder's own market strategy. thermore, they can apply to the authorities of other Member States, where the old product is still on the market.

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OPINION OF MR GEELHOED — CASE C-172/00

authority already possessed and had evalu- 75. Thirdly, in my view parallel imports of ated all the information regarding the medicinal products are per se a desirable medicinal product. This situation has in phenomenon, from the point of view of no way changed. both the internal market and the protection of public health. I refer to paragraph 40 et seq. of this Opinion. This implies that parallel imports cannot simply be termin- ated on the basis of a one-sided decision on the part of the holder of an MA.

FERRING

78. That increased responsibility of the for the Court to formulate criteria for the parallel importer, coupled with the fact limitation by the Member States of the that not all obligations can simply be right to effect parallel imports. In this transferred to him, can entail restric- regard — likewise in agreement with the tions — or conditions — being attached remarks of the Swedish Government — I to the right to effect parallel imports. can conceive of three types of restriction:

79. I consider such restrictions to be — those directly linked to the safety of the acceptable, provided that they are justified medicinal product; on a general-interest ground relating to public health (more specifically, super- vision of the safety of the medicinal prod- uct) and are necessary and proportionate.

— temporal limits;

83. In instances where it is difficult to must have a means of periodically review- imagine the transfer of obligations to the ing whether the medicinal product still parallel importer, for example those con- complies with the requirements applicable cerning the further development of the to it. medicinal product, cooperation between the national authorities of the Member States can offer a solution. This is the direction that the Court recommended in the Rhône-Poulenc Rorer and May & Baker case for the pharmacovigilance sys- tem. Mandatory cooperation between the national authorities of the Member States must ensure that the authorities in the 85. The third kind of restriction concerns importing Member State possess sufficient the obligation to apply for the grant of an information to guarantee the safety of a MA as a right within a reasonable period. I medicinal product. In fact, parallel imports consider that such an obligation can be always occur from another Member State justified in the general interest and also where an MA for the product concerned complies with the requirements of necessity still exists. and proportionality. The authorities of a Member State have a legitimate interest in assigning to a specific person full liability for a medicinal product marketed on their territory. This enables them to perform their supervisory tasks in the field of public health in the best way possible although — as was already apparent from paragraph 53 and following of this Opinion — certain obligations may also be imposed on the 84. As a second type of restriction I men- parallel importer. tioned temporal limits. In the same way as the market authorisation under Directive 65/65 is of a limited duration, so also the authorisation to effect parallel imports may be limited as to time. I would point out that under Article 10(1) of Directive 65/65, the authorisation is valid for five years and can be extended for a further period of five years. The Swedish Government recom- 86. The parallel importer must be granted a mends that the parallel import licence reasonable period within which to request should be for the same term as the (in the the MA. Furthermore, it appears to me, meantime withdrawn) MA. I support this that the parallel importer may not be proposition. There is no reason to place the forced to market existing stocks under a parallel importer in a more advantageous new name or with a new registration position, as regards the duration of the number. Provided those conditions are met, licence, than the position in which the it is not disproportionate to couple the licence holder would have found himself obligation to request an MA in his own had he continued marketing the medicinal right with the sanction of withdrawal of the product. Moreover, the Member States parallel import licence. I - 6914

87. In short, in situations where the MA for doms guaranteed by the EC Treaty — and the reference medicinal product in the thus the interests of the parallel importer. importing country has not been withdrawn The Swedish Government has expressed the at the request of the licence holder in order same viewpoint. to protect public health, it is permissible in this regard to impose restrictions on the parallel importer provided that such restric- tions relate to the safety of the medicinal product or are intended to limit the dur- ation of the right to effect parallel imports. 90. In paragraph 58,1 stated that it must be The parallel importer may himself be possible to require the licence holder to act obliged to request an MA within a reason- in good faith with regard to the parallel able period of time, or suffer withdrawal of importer. It follows from the De Peijper his parallel import licence. case, that it must be possible to oblige him to provide information to render parallel imports possible. 43 In my view, the rationale behind this is that parallel imports would otherwise not in fact be possible, inasmuch as the licence holder is the only person in possession of certain information. In my opinion the obligations of the licence Must the interests of the parallel importer holder go no further. As the Commission be taken into account? and the Swedish Government correctly state, it is not the task of the licence holder to uphold the freedoms guaranteed by the EC Treaty. The responsibility of the licence 88. Essentially, on this point, the referring holder implies that he may not impede court wishes to be informed as to whether parallel imports (by withholding infor- the licence holder must take into account mation), but, on the other hand, he cannot the interests of the parallel importer, if he be expected in his management decisions to has a choice between various adminis- take into account the interests of the trative channels. In this regard, Ferring parallel importer who is after all his com- contends that it would not be legitimate to petitor. compel it to maintain the implied licence for the old variant for the benefit of the parallel importer. Eurin -Pharm recognises the legitimacy of Ferring's desire to replace the implied licence. However, Ferring could have used other channels, which would not have led to the immediate termination of importation. The fact that an implied licence is involved

92. As I already stated in paragraph 32, — The withdrawal of an MA for the Eurin-Pharm was entitled to proceed on the reference medicinal product in the assumption that the German legislation importing country at the request of upon which its own and Ferrings' (implied) the licence holder cannot result in the licences were based was valid. None the immediate cessation of parallel less, in the case of an implied licence, it is imports, where the purpose of the not certain that the product has been withdrawal was not to protect public examined, in accordance with Articles 4 health. and 5 of Directive 65/65, with regard to its harmfulness and therapeutic efficacy. There could be public health reasons that would justify the product being examined once again if parallel imports are to continue. However, these reasons are unconnected with the moment in time of the withdrawal of the MA from the original licence holder. — Such a legal consequence must be regarded as an import restriction pro- hibited under Article 28 EC for which no justificatory ground is provided for in the Treaty relating, for example in the present case, to public health. It should also be taken into consideration 93. It is therefore not permissible — in that the medicinal product has been view of the fact that it is an implied licence marketed in Germany for a consider- with which we are dealing here and not a able time, and that it is not disputed full MA — that parallel imports should be that the product complies with public- terminated without provision for a reason- health requirements. able transitional period. Conversely, I con- sider it acceptable — in so far as required by public health and on condition that the preparation has not already been investi- gated — that the parallel importer should undergo the full procedure under Directive 65/65 when applying for an MA. The — However, restrictions may be imposed transitional period should take this into on the parallel importer with a view to account where appropriate. supervision of the medicinal product, I - 6916

95. In the legal proceedings before the Court much attention has been paid to the fact that not only was the MA with- 98. The fact that Ferring has placed a new drawn at the request of the licence holder, variant on the market, cannot be decisive in but that the licence holder at the same time determining whether parallel imports placed a similar medicinal product on the should be terminated. However, this fact market. could possibly play a role in the following

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question. Under what conditions may the 102. Ferring proposes that this question old variant remain on the market when a should be answered in the negative. More- decision has been taken regarding the over, Ferring considers that the reply to this parallel importer's request for an MA? question is immaterial to the present case. Eurin-Pharm states that there is no dif- ference in therapeutic effect between the old and new variants. The distinction relates purely to an excipient, not to the active ingredient.

99. In view of the fact that the referring judge's questions do not relate to this follow-up situation, I recommend that the Court should reply as follows: In the situation under examination it is not important that the original licence holder 103. In paragraph 59,1 referred to Smith Sc markets a similar product. Nephew and Primecrown in which the Court clarified the cases of parallel imports in which the same medicinal product is involved. In summary, both the origin and the composition must be the same. The origin is not at issue in this case.

otherwise totally comparable. If the old imports. The packaging of the old product variant is kept at room temperature, it loses always states that it must be kept cool. 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 107. At the hearing Ferring also pointed public-health problems. Having regard to out that the risk of confusion ceases as soon the case-law of the Court, I consider that as the parallel importer obtains a licence in the distinction between the two variants is his own right. From that point in time two immaterial and that both variants can be different preparations exist marketed under regarded as the same medicinal product for different names. the purposes of the Community rules on the marketing of medicinal products.

108. The Commission points out that the question whether the presence of two vari- ants 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 The (un)desirability of two variants being marketed. The parallel importer can always present side by side on the market 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.

110. At the hearing Ferring also pointed to the possibility that, should the parallel 112. Barring evidence to the contrary, the importer hold a separate authorisation, fact that the old variant is still marketed in the variants would be on the market under other Member States reinforces the argu- different names. I do not fully understand ment that this variant does not present any this argument. In my opinion the original safety risks and that parallel imports of the holder of an MA can give a new variant a old variant continue to be possible. Fur- new name if he wishes to alert the con- thermore, according to Eurin-Pharm, the sumer to a difference with regard to the old new product was not available in other variant. In the present case Ferring did this countries from which it could have been by marketing the new variant under the exported. Eurin-Pharm states, therefore, name 'Minirin Nasenspray 5 ml'. This is that it was only able to import the old nothing to do with the parallel importer. product into Germany.

113. In short, if a variant of a medicinal product is (still) lawfully marketed in one Old variant still available in other Member Member State, then these variants may also States be imported into another Member State. It would be otherwise only in the event of exceptional and specific public health cir- cumstances arising in the latter Member State.

111. In my view the crux of the matter is 44 — I refer to the Opinion of Advocate General La Pergola in Rhône-Poulenc Rorer and May & Baker (cited in that the possibility for a medicinal product footnote 10).

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. I - 6921

OPINION OF MR GEELHOED — CASE C-172/00

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.

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