(Reference for a preliminary ruling from the Verwaltungsgericht Berlin)

(Medicinal products for human use — Homeopathic medicinal products — National provision excluding from the special, simplified registration procedure a medicinal product composed of known homeopathic substances if its use as a homeopathic medicinal product is not generally known)

Opinion of Advocate General Léger delivered on 27 January 2005

Judgment of the Court (Second Chamber), 12 May 2005

Summary of the Judgment

Approximation of laws — Medicinal products — Marketing authorisation — Special, simplified registration procedure — Conditions — Medicinal product composed of several homeopathic substances — Requirement of proof of therapeutic efficacy — None

(European Parliament and Council Directive 2001/83, Arts 14 and 15)

Articles 14 and 15 of Directive 2001/83 on the Community code relating to medicinal products for human use must be interpreted as meaning that they preclude a national provision which does not permit use of the special simplified registration procedure for a medicinal product composed of several known homeopathic substances if its use as a homeopathic medicine is not generally known.

As is apparent from Article 14(1) of Directive 2001/83, read in conjunction with Article 1(5), a homeopathic medicinal product may be subject to the special simplified registration procedure in so far as it is administered orally or externally, no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto and, finally, there is a sufficient degree of dilution to guarantee its safety. In accordance with Article 15 of that directive, only the homeopathic stock or stocks from which that combination is derived must be well-known. However, that provision does not require the submission of a bibliography showing that the effects of the homeopathic medicinal product itself have been identified. As regards proof of therapeutic efficacy, Article 14(3) of that directive expressly states that such proof is not required for homeopathic medicinal products registered in accordance with paragraph (1) of this article.

(see paras 16, 20, 22, 26, operative part)

12 May 2005 (*)

(Medicinal products for human use – Homeopathic medicinal products – National provision excluding from the special, simplified registration procedure a medicinal product composed of known homeopathic substances if its use as a homeopathic medicinal product is not generally known)

In Case C-444/03,

REFERENCE for a preliminary ruling under Article 234 EC from the Verwaltungsgericht Berlin (Germany), made by decision of 28 August 2003, received at the Court on 21 October 2003, in the proceedings

Bundesrepublik Deutschland,

THE COURT (Second Chamber),

composed of C.W.A. Timmermans, President of the Chamber, R. Silva de Lapuerta, C. Gulmann (Rapporteur), P. Kūris and J. Klučka, Judges,

Advocate General: P. Léger,

Registrar: K. Sztranc, Administrator,

having regard to the written procedure and further to the hearing on 11 November 2004,

after considering the observations submitted on behalf of:

–meta Fackler KG, by T. Fritz, Rechtsanwalt,

–Bundesrepublik Deutschland, by H.G. Schweim and G. Akbarian, acting as Agents,

–the Commission of the European Communities, by B. Schima and B. Stromsky, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 27 January 2005,

gives the following

1 The questions referred for a preliminary ruling concern the interpretation of Articles 14 and 15 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).

2 That reference was made in the course of proceedings between meta Fackler KG (‘meta Fackler’) and the Bundesrepublik Deutschland, concerning the dismissal of an application to register a homeopathic medicinal product submitted by that company.

Law

Community legislation

Directive 2011/92

Recitals 7 to 9 of Directive 2011/92 state:

‘(7) 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. …

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

(9) 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 2011/92 provides:

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

(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

‘Is the rule contained in Paragraph 39(2) No 7a of the AMG compatible with Directive 2001/83/EC … in so far as it does not permit registration of a medicinal product composed of bibliographically identified homeopathic constituents if its “use as a homeopathic … medicinal product is not generally known”?

In particular:

(a)Are only “traditional” homeopathic medicinal products subject to the special, simplified registration procedure under Article 14 et seq. of Directive 2001/83/EC?

(b)If the answer to this question is in the affirmative, can a medicinal product also be considered to be “traditional” if it is manufactured using bibliographically identified homeopathic stocks without having been in actual homeopathic use in that combination prior to the registration applied for,

or:

Does the second indent … of Article 15 of Directive 2001/83/EC permit a Member State to require that, for registration of a homeopathic medicinal product which is manufactured using a number of homeopathic stocks, a bibliography must be produced that refers to the combined preparation as such?’

The questions referred for a preliminary ruling

15By its questions the national court asks, essentially, whether Articles 14 and 15 of Directive 2001/83 must be interpreted as meaning that they preclude a national provision which does not permit use of the special simplified registration procedure for a medicinal product composed of several known homeopathic substances if its use as a homeopathic medicine is not generally known.

16Under Article 14(1) of Directive 2001/83, read in conjunction with Article 1(5), a homeopathic medicinal product, that is to say a medicinal product prepared from products, substances or combinations called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States, may be subject to the special simplified registration procedure only in so far as it is administered orally or externally, no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto and, finally, there is a sufficient degree of dilution to guarantee its safety.

17Consequently, general awareness of the homeopathic medicinal product, as required by the German law, is not among the conditions which such a medicinal product must satisfy in order to be eligible for the special simplified registration procedure as provided for in Article 14(1) of Directive 2001/83.

18The Bundesrepublik Deutschland submits that the second indent of Article 15 of Directive 2001/83 must be interpreted as meaning that the homeopathic character of the medicinal product prepared from one or more stocks must be proved, and cannot simply be deduced from the homeopathic character of the stocks from which it is derived. For that purpose, it is necessary for that medicinal product to be tested so as to identify its effects and, in particular, its safety in homeopathic use. It follows that only a medicinal product generally known, for which an adequate bibliography exists, may be subject to the special simplified registration procedure.

19That view cannot be accepted.

20It is clear from Article 15 of Directive 2001/83, which lists the documents which must be included in the application for registration by special simplified procedure for a homeopathic medicinal product, that only the homeopathic stock or stocks from which that combination is derived must be well-known. Thus, the first indent of that provision states that the scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks is to be stated, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered, while the second indent of that provision requires a dossier to be lodged describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate bibliography. However, a bibliography showing that the effects of the homeopathic medicinal product itself have been identified is not required.

21As the Commission of the European Communities rightly stated, the safety of such a medicinal product is, generally, in accordance with the third indent of Article 14(1) of Directive 2001/83, ensured primarily by the degree to which it is diluted.

22As regards proof of therapeutic efficacy, Article 14(3) of Directive 2001/83 expressly states that such proof is not required for homeopathic medicinal products registered in accordance with paragraph (1).

23The fact that general awareness of the homeopathic medicinal product does not have to be demonstrated in order for it to be registered according to a special simplified registration procedure is not called into question by the fact that the 10th recital in the preamble to Directive 92/73 expressly refers to ‘a simplified registration procedure for … traditional homeopathic medicinal products’.

24In that connection, it should first be recalled that that directive was repealed and replaced by Directive 2001/83, the 21st recital to which does not repeat the reference to the traditional nature of the homeopathic medicinal products for which it is desirable to lay down a special simplified registration procedure.

25Second, even if that omission was due, as the Bundesrepublik Deutschland argues, to an oversight by the legislature during the codification into a single text of the various directives concerning medicinal products for human use, the concept of traditional homeopathic medicinal products which are traditional, and therefore generally known, is not consistent, as is clear from the foregoing, with Articles 14 and 15 of Directive 2001/83. The preamble to a Community act cannot be relied on as a ground for derogating from the actual provisions of the act in question (see Case C-162/97 Nilsson and Others [1998] ECR I-7477, paragraph 54).

26It follows that the answer to the questions referred for a preliminary ruling must be that Articles 14 and 15 of the Directive must be interpreted as meaning that they preclude a national provision which does not permit use of the special simplified registration procedure for a medicinal product composed of several known homeopathic substances where its use as a homeopathic medicinal product is not generally known.

Costs

27Since 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 (Second Chamber) hereby rules:

Articles 14 and 15 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 must be interpreted as meaning that they preclude a national provision which does not permit use of the special simplified registration procedure for a medicinal product composed of several known homeopathic substances where its use as a homeopathic medicinal product is not generally known.

[Signatures]

*

Language of the case: German.