(Reference for a preliminary ruling from the Hoge Raad der Nederlanden)

(Community code relating to medicinal products for human use – Articles 28 EC and 30 EC – Registration and marketing authorisation – Anthroposophic medicinal products)

Opinion of Advocate General Bot delivered on 24 May 2007

Judgment of the Court (First Chamber), 20 September 2007

Summary of the Judgment

Approximation of laws – Medicinal products for human use – Authorisation to market

(European Parliament and Council Directive 2001/83, Art. 6)

Anthroposophic medicinal products may be marketed only on condition that they have been authorised under one of the procedures referred to in Article 6 of Directive 2001/83 on the Community code relating to medicinal products for human use.

(see para. 43, operative part)

20 September 2007 (*)

(Community code relating to medicinal products for human use – Articles 28 EC and 30 EC – Registration and marketing authorisation – Anthroposophic medicinal products)

In Case C‑84/06,

REFERENCE for a preliminary ruling under Article 234 EC, by the Hoge Raad der Nederlanden (Netherlands), made by decision of 27 January 2006, received at the Court on 10 February 2006, in the proceedings

Antroposana, Patiëntenvereniging voor Antroposofische Gezondheidszorg,

Nederlandse Vereniging van Antroposofische Artsen,

Weleda Nederland NV,

Wala Nederland NV,

THE COURT (First Chamber),

composed of P. Jann, President of Chamber, R. Schintgen, A. Tizzano (Rapporteur), A. Borg Barthet and E. Levits, Judges,

Advocate General: Y. Bot,

Registrar: M. Ferreira, Principal Administrator,

having regard to the written procedure and further to the hearing on 15 March 2007,

after considering the observations submitted on behalf of:

– Antroposana, Patiëntenvereniging voor Antroposofische Gezondheidszorg, Nederlandse Vereniging van Antroposofische Artsen, Weleda Nederland NV and Wala Nederland NV, by S. Evers and J. Sijmons, advocaten,

– the Netherlands Government, by H.G. Sevenster and P. van Ginneken, acting as Agents,

– the German Government, by M. Lumma and C. Schulze-Bahr, acting as Agents,

– the Italian Government, by I.M. Braguglia, acting as Agent, assisted by G. De Bellis, avvocato dello Stato,

– the Commission of the European Communities, by B. Stromsky and M. van Beek, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 24 May 2007,

gives the following

1 This reference for a preliminary ruling concerns the interpretation of 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), and of Articles 28 EC and 30 EC.

2 The reference was made in proceedings between the Staat der Nederlanden (Netherlands State) and Antroposana, Patiëntenvereniging voor Antroposofische Gezondheidszorg (Association of Patients for Anthroposophic Health Care), Nederlandse Vereniging van Antroposofische Artsen (Netherlands Association of Anthroposophic Doctors), Weleda Nederland NV and Wala Nederland NV (hereinafter referred to collectively as ‘Antroposana and Others’) – the two last-mentioned parties being companies which manufacture and market anthroposophic medicinal products – concerning the conditions for the grant of authorisation to place anthroposophic medicinal products on the market.

Legal context

Community rules

Directive 2001/83

Recitals 7 to 9 of Directive 2001/83 state:

‘Development consent for public and private projects which are likely to have significant effects on the environment should be granted only after an assessment of the likely significant environmental effects of those projects has been carried out. …

Projects belonging to certain types have significant effects on the environment and those projects should, as a rule, be subject to a systematic assessment.

Projects of other types may not have significant effects on the environment in every case and those projects should be assessed where the Member States consider that they are likely to have significant effects on the environment.’

Article 2(1) of that directive provides:

‘Member States shall adopt all measures necessary to ensure that, before development consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects on the environment. Those projects are defined in Article 4.’

Under Article 3(1) of that directive:

‘The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case, the direct and indirect significant effects of a project on the following factors:

…

(b) biodiversity, with particular attention to species and habitats protected under [Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), as amended by Council Directive 2013/17/EU of 13 May 2013 (OJ 2013 L 158, p. 193) (“Directive 92/43”)] and Directive 2009/147/EC [of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ 2010 L 20, p. 7)];

…’

Article 4 of Directive 2001/83 provides:

‘Subject to Article 2(4), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10.

Subject to Article 2(4), for projects listed in Annex II, Member States shall determine whether the project shall be made subject to an assessment in accordance with Articles 5 to 10. Member States shall make that determination through:

(a) a case-by-case examination;

(b) thresholds or criteria set by the Member State.

Member States may decide to apply both procedures referred to in points (a) and (b).

Where a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. Member States may set thresholds or criteria to determine when projects need not undergo either the determination under paragraphs 4 and 5 or an environmental impact assessment, and/or thresholds or criteria to determine when projects shall in any case be made subject to an environmental impact assessment without undergoing a determination set out under paragraphs 4 and 5.

Where Member States decide to require a determination for projects listed in Annex II, the developer shall provide information on the characteristics of the project and its likely significant effects on the environment. The detailed list of information to be provided is specified in Annex IIA. The developer shall take into account, where relevant, the available results of other relevant assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The developer may also provide a description of any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

The competent authority shall make its determination, on the basis of the information provided by the developer in accordance with paragraph 4 taking into account, where relevant, the results of preliminary verifications or assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The determination shall made available to the public and:

(a) where it is decided that an environmental impact assessment is required, state the main reasons for requiring such assessment with reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not required, state the main reasons for not requiring such assessment with reference to the relevant criteria listed in Annex III, and, where proposed by the developer, state any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

Member States shall ensure that the competent authority makes its determination as soon as possible and within a period of time not exceeding 90 days from the date on which the developer has submitted all the information required pursuant to paragraph 4. In exceptional cases, for instance relating to the nature, complexity, location or size of the project, the competent authority may extend that deadline to make its determination; in that event, the competent authority shall inform the developer in writing of the reasons justifying the extension and of the date when its determination is expected.’

Annex II.A of that directive contains the list of ‘information to be provided by the developer on the projects listed in Annex II’. That list reads as follows:

‘1. A description of the project, including in particular:

(a) a description of the physical characteristics of the whole project and, where relevant, of demolition works;

(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas likely to be affected.

(a) the expected residues and emissions and the production of waste, where relevant;

(b) the use of natural resources, in particular soil, land, water and biodiversity.

Annex III to that directive sets out the ‘criteria to determine whether the projects listed in Annex II should be subject to an environmental impact assessment’.

Directive 2014/52

Recitals 11 and 29 of Directive 2014/52 state:

‘(11) The measures taken to avoid, prevent, reduce and, if possible, offset significant adverse effects on the environment, in particular on species and habitats protected under [Directive 92/43] and Directive 2009/147 …, should contribute to avoiding any deterioration in the quality of the environment and any net loss of biodiversity, in accordance with the [European] Union’s commitments in the context of the [United Nations Convention on Biological Diversity, signed in Rio de Janeiro on 5 June 1992,] and the objectives and actions of the Union Biodiversity Strategy up to 2020 laid down in the [Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions] of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ [(COM(2011) 244 final)]’

…

(29) When determining whether significant effects on the environment are likely to be caused by a project, the competent authorities should identify the most relevant criteria to be considered and should take into account information that could be available following other assessments required by Union legislation in order to apply the screening procedure effectively and transparently. In this regard, it is appropriate to specify the content of the screening determination, in particular where no environmental impact assessment is required. Moreover, taking into account unsolicited comments that might have been received from other sources, such as members of the public or public authorities, even though no formal consultation is required at the screening stage, constitutes good administrative practice.’

Directive 92/43

Article 6(3) of Directive 92/43 provides:

‘Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site’s conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public.’

Article 12(1) of that directive provides:

‘Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

(a) all forms of deliberate capture or killing of specimens of these species in the wild;

(b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

(c) deliberate destruction or taking of eggs from the wild;

(d) deterioration or destruction of breeding sites or resting places.’

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

Irish law

22In parallel with those substantive proceedings, Antroposana and Others also brought an action against the Netherlands State before the judge hearing applications for interim relief of the Rechtbank te ’s-Gravenhage, asking for an order directing the Netherlands State to suspend application of the prohibition contained in Article 3(4) of the Law until judgment had been delivered on the substance of the case or, in the alternative, to ‘tolerate’ the manufacture and marketing of anthroposophic medicinal products.

23By decision of 15 April 2003, the judge hearing the application for interim relief granted the alternative form of order sought by Antroposana and Others and ordered the Netherlands State to ‘tolerate’ the manufacture and marketing of anthroposophic medicinal products, but only in the case of those prescribed by a doctor.

24The Netherlands State appealed to the Gerechtshof te ’s-Gravenhage. Antroposana and Others lodged a cross-appeal before the same court.

25By judgment of 27 May 2004, the Gerechtshof te ’s-Gravenhage quashed the interim order to the extent that it contained a restriction limiting its scope to anthroposophic medicinal products prescribed by a doctor. For the rest, it upheld the judge’s decision.

26The Netherlands State appealed to the Hoge Raad der Nederlanden, which, in considering the appeal, decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:

1.‘1. Does Directive 2001/83/EC … oblige Member States to make anthroposophic medicinal products which are not at the same time homeopathic medicinal products subject to the requirements in respect of authorisation as set out in Chapter 1 of Title III of that directive?

2.If the answer to Question 1 is in the negative: is the Netherlands statutory provision which makes those anthroposophic medicinal products subject to the aforementioned requirements in respect of authorisation an exception to the prohibition under Article 28 EC which is authorised by virtue of Article 30 EC?’

27In its first question, the national court is essentially asking the Court whether anthroposophic medicinal products may be marketed only on condition that they have been authorised under one of the procedures laid down in Directive 2001/83.

28The Italian and Netherlands Governments, as well as the Commission of the European Communities, propose that the Court should answer that question in the affirmative. They argue, in particular, that the directive carried out a complete harmonisation of national authorisation and registration procedures for medicinal products for human use, with a view to their being placed on the market in the Member States.

29On the other side, Antroposana and Others suggest – as does the German Government – that the Court should answer the question in the negative. They contend that the Member States are free to lay down or maintain specific authorisation procedures for the categories of medicinal product for which Directive 2001/83 does not provide special and adequate procedures.

30In order to answer this question, it should be pointed out that, under the first subparagraph of Article 1(2) of Directive 2001/83, a medicinal product is ‘[a]ny substance or combination of substances presented for treating or preventing disease in human beings’. According to the second subparagraph of that provision, ‘[a]ny substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings’ is likewise to be considered a medicinal product.

31The directive thus gives two definitions of medicinal products, one ‘by virtue of their presentation’ and one ‘by virtue of their function’. A product is a medicinal product if it falls within either of those definitions (Case C‑60/89 Monteil and Samanni [1991] ECR I-1547, paragraphs 10 and 11). It is also settled case-law that those two definitions are to be broadly construed (see, to that effect, Case 35/85 Tissier [1986] ECR 1207, paragraph 26; Monteil and Samanni, paragraph 23, and Case C‑112/89 Upjohn [1991] ECR I-1703, paragraph 16).

32In the present case, it can be seen from the order for reference that the products at issue in the main proceedings are presented as ‘medicinal products’ prepared on the basis of the principles of anthroposophic medicine.

33It follows that such products come within the definition of ‘medicinal products’ laid down in Article 1(2) of Directive 2001/83.

34It should be noted that the first subparagraph of Article 6(1) of Directive 2001/83 provides that ‘[n]o 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’.

35Consequently, it is absolutely clear from the terms of that provision that, as the Court has already pointed out, if medicinal products are to be marketed in the Community, authorisation must first have been obtained, in accordance with the procedures laid down in the directive, for their placing on the market (see, to that effect, Joined Cases C‑211/03, C‑299/03 and C‑316/03 to C‑318/03 HLH Warenvertrieb and Orthica [2005] ECR I-5141, paragraph 57).

36Moreover, that interpretation of the provision in question is, as the Advocate General pointed out in points 56 to 60 of his Opinion, in accordance with the objectives which Directive 2001/83 seeks to attain, namely, the elimination of hindrances to trade in medicinal products between the Member States and the protection of public health.

37It follows from all the foregoing considerations that products coming within the definition of ‘medicinal products’ in Article 1(2) of Directive 2001/83 which are not mentioned in the Annex to Regulation No 2309/93, now replaced by the Annex to Regulation No 726/2004, must be registered under one of the procedures laid down in the aforementioned directive.

38That conclusion is not called into question by the argument put forward by Antroposana and Others and the German Government to the effect that the harmonisation process in the field of medicinal products for human use is being carried out in stages and is not yet complete. Accordingly, the Member States retain their freedom to lay down or maintain specific authorisation procedures for certain medicinal products, parallel to the procedures applicable under Directive 2001/83, in so far as that directive does not lay down special and adequate procedures for those products.

39In support of that argument, Antroposana and Others, and the German Government, refer, first of all, to the 14th recital in the preamble to Directive 2001/83 according to which the directive ‘represents an important step towards achievement of the objective of the free movement of medicinal products’ and ‘[f]urther measures [to] abolish any remaining barriers to the free movement [may] be necessary’. Secondly, they refer to the fact that Directive 2004/24 introduced ‘traditional use registration’ for certain traditional herbal medicinal products, mentioned in paragraph 14 of this judgment.

40However, as the Advocate General remarked in points 61 to 68 of his Opinion, the line of reasoning adopted by Antroposana and Others and the German Government is based on the erroneous premise that complete harmonisation in the field of medicinal products for human use is incompatible with the fact that that field is in a state of continuing evolution.

41In reality, the fact that Directive 2001/83 lays down a complete system of authorisation procedures for medicinal products in no way means that the Community legislature cannot amend or adapt those procedures or, if necessary, introduce new ones so as better to attain the objectives of removing barriers to intracommunity trade and the protection of public health.

42In addition, the circumstance, relied on by Antroposana and Others, that some Member States did not comply with Directive 2001/83, when it was amended in 2004 – in that they introduced or maintained registration or authorisation procedures not provided for in the directive – does not affect the fact that the directive established a complete regulatory framework for registration and market authorisation procedures in respect of medicinal products for human use.

43In the light of all of the foregoing considerations, the answer to the first question must be that anthroposophic medicinal products may be marketed only on condition that they have been authorised under one of the procedures referred to in Article 6 of Directive 2001/83.

44Having regard to the answer to the first question, there is no need to answer the national court’s second question.

Costs

45Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (First Chamber) hereby rules:

Anthroposophic medicinal products may be marketed only on condition that they have been authorised under one of the procedures referred to in Article 6 of Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

[Signatures]

*

Language of the case: Dutch.