JUDGMENT OF THE COURT (First Chamber)
(Articles 28 EC and 30 EC – Free movement of goods – Directive 2001/83/EC –
Products based on medicinal herbs – Products classified as medicinal products –
Products lawfully produced or marketed as food supplements or dietary products
in other Member States – Meaning of ‘medicinal product’ – Marketing
authorisation – Restriction – Justification – Public health – Consumer
protection – Proportionality – Decision No 3052/95/EC – Procedure for the
exchange of information on national measures derogating from the principle of
the free movement of goods within the Community)
In Case C‑88/07,
ACTION under
Article 226 EC for failure to fulfil obligations, brought on 15 February 2007,
Commission
of the European Communities, represented by S. Pardo
Quintillán and A. Alcover San Pedro, acting as Agents, with an address for
service in Luxembourg,
applicant,
v
Kingdom of
Spain, represented by J. Rodríguez Cárcamo, acting as Agent, with an address for
service in Luxembourg,
defendant,
THE COURT (First Chamber),
composed of P.
Jann, President of Chamber, M. Ilešič (Rapporteur), A. Tizzano, A. Borg Barthet
and E. Levits, Judges,
Advocate
General: J. Mazák,
Registrar:
M. Ferreira, Principal Administrator,
having
regard to the written procedure and further to the hearing on 25 June 2008,
after
hearing the Opinion of the Advocate General at the sitting on 16 October 2008,
gives the
following
Judgment
1 By its action, the
Commission of the European Communities asks the Court to declare that:
– by withdrawing from the
market a number of herbal products lawfully produced and/or marketed in another
Member State, under an administrative practice consisting in withdrawing from
the market any product with herbal constituents not included in the annex to
the Ministerial Order on the creation of a special register of medicinal
herb-based preparations (Orden Ministerial por la que se establece el registro
especial para preparados a base de especies vegetales medicinales)
of 3 October 1973 (BOE No 247 of 15 October 1973, p. 19866), as
amended (‘the 1973 Order’) on the ground that it is deemed to be a medicinal
product marketed without the requisite authorisation, and
– by not communicating that
measure to the Commission,
the Kingdom
of Spain has failed to fulfil its obligations under Articles 28 EC and 30 EC
and Articles 1 and 4 of Decision No 3052/95/EC of the European Parliament
and of the Council of 13 December 1995 establishing a procedure for the
exchange of information on national measures derogating from the principle of
the free movement of goods within the Community (OJ 1995 L 321,
p. 1).
2 The Commission states that
its action relates to the marketing of products based on medicinal herbs, in
other words products containing one or more herbs which, because of their
properties and their physiological effects, can be used as ingredients in
medicinal products or in other types of products, such as food supplements.
Legal context
Community
legislation
Directive
2001/83/EC
3 Article 1 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), as amended by Directive 2004/27/EC of the European
Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34,
‘Directive 2001/83’), provides:
‘For the
purposes of this Directive, the following terms shall bear the following
meanings:
…
2. Medicinal product:
(a) Any substance or combination of
substances presented as having properties for treating or preventing disease in
human beings; or
(b) Any substance or combination of
substances which may be used in or administered to human beings either with a
view to restoring, correcting or modifying physiological functions by exerting
a pharmacological, immunological or metabolic action, or to making a medical
diagnosis;
3. Substance:
Any matter
irrespective of origin which may be:
…
– vegetable, e.g:
micro-organisms,
plants, parts of plants, vegetable secretions, extracts,
…
…
29. Traditional herbal medicinal
product:
A herbal
medicinal product that fulfils the conditions laid down in Article 16a(1);
30. Herbal medicinal product:
Any
medicinal product, exclusively containing as active ingredients one or more
herbal substances or one or more herbal preparations, or one or more such
herbal substances in combination with one or more such herbal preparations;
31. Herbal substances:
All mainly
whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an
unprocessed, usually dried, form, but sometimes fresh. Certain exudates that
have not been subjected to a specific treatment are also considered to be
herbal substances. Herbal substances are precisely defined by the plant part
used and the botanical name according to the binomial system (genus, species,
variety and author);
32. Herbal preparations:
Preparations
obtained by subjecting herbal substances to treatments such as extraction,
distillation, expression, fractionation, purification, concentration or
fermentation. These include comminuted or ground herbal substances, tinctures,
extracts, essential oils, expressed juices and processed exudates.’
4 Article 2(1) and (2) of
Directive 2001/83 provide:
‘1. This
Directive shall apply to medicinal products for human use intended to be placed
on the market in Member States and either prepared industrially or manufactured
by a method involving an industrial process.
2. In
cases of doubt, where, taking into account all its characteristics, a product
may fall within the definition of a “medicinal product” and within the
definition of a product covered by other Community legislation the provisions
of this Directive shall apply.’
5 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 unless an authorisation has been granted in accordance
with [Council] Regulation (EEC) No 2309/93 [of 22 July 1993 laying down
Community procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a European Agency for
the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1)]’.
6 Title III of Directive
2001/83 contains a Chapter 2a, headed ‘Specific provisions applicable to
traditional herbal medicinal products’, which contains Articles 16a to 16i.
That chapter establishes, under certain conditions, a simplified registration
procedure for traditional herbal medicinal products.
7 To qualify for such a
procedure, a traditional herbal medicinal product must have been in medicinal
use throughout a period of at least 30 years preceding the date of the
application for registration, including at least 15 years within the European
Community (Articles 16a(1)(d) and 16c(1)(c) of Directive 2001/83).
8 It is also necessary that
the data on the traditional use of the medicinal product be sufficient; in
particular the product must prove not to be harmful in the specified conditions
of use and the pharmacological effects or efficacy of the medicinal product
must be plausible on the basis of longstanding use and experience (Article
16a(1)(e) of Directive 2001/83).
9 Article 16f(1) and (2) of
Directive 2001/83 provide:
‘1.
A list of herbal substances, preparations
and combinations thereof for use in traditional herbal medicinal products shall
be established in accordance with the procedure referred to in Article 121(2).
The list shall contain, with regard to each herbal substance, the indication,
the specified strength and the posology, the route of administration and any other
information necessary for the safe use of the herbal substance as a traditional
medicinal product.
2. If
an application for traditional-use registration relates to a herbal substance,
preparation or a combination thereof contained in the list referred to in
paragraph 1, the data specified in Article 16c(1)(b), (c) and (d) do not need
to be provided. Article 16e(1)(c) and (d) shall not apply.’
Decision
No 3052/95
10 The third to sixth recitals in the
preamble to Decision No 3052/95 are worded as follows:
‘… the
transparency of national measures banning products may make it easier to deal
quickly and at the appropriate level with problems which may jeopardize the
free movement of goods, inter alia by approximating such measures in good time
or adjusting them pursuant to Article [28 EC];
…, in order
to facilitate such transparency, a simple and pragmatic procedure should be
established for the exchange of information between Member States and with the
Commission so that any problems that may arise in connection with the operation
of the internal market can be settled satisfactorily for both businesses and
consumers;
… the main
purpose of this procedure is to enhance knowledge concerning the implementation
of the free movement of goods in non‑harmonised sectors and to identify the
problems encountered with a view to finding appropriate solutions to them;
… such a
procedure should cover only those cases in which a Member State takes steps to
prevent, on grounds of non-conformity with its own national rules, the free
movement or placing on the market of goods lawfully produced or marketed in
another Member State’.
11 Article 1 of Decision No 3052/95
provides:
‘Where a
Member State takes steps to prevent the free movement or placing on the market
of a particular model or type of product lawfully produced or marketed in
another Member State, it shall notify the Commission accordingly where the
direct or indirect effect of the measure is:
– a general ban on the
goods,
– a refusal to allow the
goods to be placed on the market,
…
or
– withdrawal of the goods
from the market.’
12 Article 4(2) of Decision
No 3052/95 states that ‘[t]he information referred to in paragraph 1 shall
be communicated within 45 days of the date on which the measure referred to in
Article 1 is taken’.
National
legislation
13 Article 8(1) of Law No 25/1990 on
medicinal products (Ley 25/1990 del Medicamento) of 20 December 1990 (BOE
No 306 of 22 December 1990, p. 38228), provides:
‘For the
purposes of this legislation, the following terms have the following meanings …
“medicinal product”: any medicinal substance and any association or combination
of such substances intended for use by human beings or animals which is
presented as having properties which facilitate the prevention, diagnosis,
treatment, relief or cure of diseases or illnesses, or which affect physical
functions or mental state. Medicinal substances or combinations of such
substances which can be administered to human beings or animals for the above
purposes, even if they are offered for sale without explicit reference to those
purposes, are also deemed to be medicinal products.’
14 Under Article 9(1) of Law
No 25/1990, ‘no proprietary medicinal product or any other medicinal
product for human use manufactured industrially may be placed on the market
without prior marketing authorisation from the Spanish Medicines Agency and
inclusion in the register of proprietary medicinal products, or without a
Community authorisation in accordance with the provisions of Regulation ...
No 2309/93’.
15 Article 42 of Law No 25/1990,
headed ‘Herbal medicinal products’, provides:
‘1. Herbs
and mixtures of them and any preparations obtained from herbs in the form of
extracts, lyophilisates, distillations, tinctures, decoctions or any other
galenic preparation, which are presented as having a therapeutic, diagnostic or
preventive value will be subject, as appropriate, to the rules relating to
magistral formulas, officinal formulas or proprietary medicinal products, and
in accordance with the specific requirements laid down by legislation.
2. The
Ministry of Health and Consumer Affairs shall establish a list of herbs the
sale of which to the public is restricted or prohibited because of their
toxicity.
3. Herbs
which are traditionally regarded as medicinal and which are offered for sale
without reference to therapeutic, diagnostic or preventive properties may be
freely sold to the public, but door-to-door selling of them is prohibited.’
16 The list referred to in Article 42(2)
of Law No 25/1990 is to be found in the annex to Order SCO/190/2004 of the
Ministry of Health and Consumer Affairs establishing the list of plants sale of
which to the public is prohibited or restricted because of their toxicity
(Orden SCO/190/2004 por la que se establece la lista de plantas
cuya venta al público queda prohibida o restringida por razón de su toxicidad)
of 28 January 2004 (BOE No 32 of 6 February 2004, p. 5061, ‘the 2004
Order’).
17 Article 1 of the 2004 Order states that
‘sale [of the plants listed] and sale of preparations based on them to the
public is prohibited because of their toxicity’ and that ‘their use and their
placing on the market are limited to the production of proprietary medicinal
products, magistral formulas, officinal preparations and homeopathic strains,
and to the purposes of research’. The annex in question lists 197 herbs.
18 Article 1 of the 1973 Order provides:
‘Preparations
the constituents of which are exclusively one or more medicinal herbs, whole
parts of such herbs, or such herbs in crushed or ground form shall be listed in
a special register by the appropriate departments of the Directorate General
for Health.’
19 Article 2 of the 1973 Order provides:
‘There shall
not be listed in that special register:
(a) preparations
for immediate use which contain a single medicinal herb – or parts of it –
listed in the annex and which state that fact clearly on the external packaging
of the product;
(b) preparations
for immediate use based on extracts, tinctures, distillations, decoctions or
any other galenic preparation, obtained from medicinal herbs, in which case
they shall in all circumstances be treated as proprietary medicinal products.’
20 The 1973 Order has annexed to it the
list of medicinal herbs referred to in Article 2(a) of that order. That
list was last updated in 1976 and extends to 119 herbs.
21 It is common ground that ‘herbs which
are traditionally regarded as medicinal’, within the meaning of Article 42(3)
of Law No 25/1990 are treated by the competent Spanish authorities in the
same way as the medicinal herbs listed in the annex to the 1973 Order, with the
result that preparations which, first, satisfy the conditions of Article 2(a)
of the 1973 Order and, secondly, are offered for sale without reference to
therapeutic, diagnostic or preventive properties may be freely sold to the
public, in accordance with Article 42(3) of Law No 25/1990.
22 Law No 25/1990 was repealed by Law
No 29/2006 on the guarantees and rational use of medicines and health
products (Ley 29/2006 de garantías y uso racional de los medicinal productos y
productos sanitarios) of 26 July 2006 (BOE No 178 of 27 July 2006,
p. 28122), which came into force on 28 July 2006. Article 51 of the latter
law essentially reproduces Article 42 of Law No 25/1990.
Pre-litigation procedure
23 In several letters sent in 2004 to
departments of the Commission, three Spanish companies, Ynsadiet SA
(‘Ynsadiet’), Laboratorios Tregor SL (‘Tregor’) and Laboratorios Taxón SL
(‘Taxón’) complained that, between 2002 and 2003, the Agencia española de
medicamentos y productos sanitarios (Spanish Drugs and Health Products Agency,
‘AEMPS’) had withdrawn from the Spanish market more than 200 products based on
medicinal herbs on the ground that they were medicinal products without any
authorisation to be placed on the market (‘marketing authorisation’), although
those products were lawfully marketed in other Member States as food
supplements or dietary products. Other complaints on the same ground were made
to the Commission in 2005 and 2006.
24 According to those complaints, the
classification by AEMPS of those products as medicinal products was often based
on the fact that the products withdrawn from the market contained medicinal
herbs which were not listed in the annex to the 1973 Order.
25 The Commission considered that the
abovementioned decisions to withdraw goods from the market were contrary to
Article 28 EC and that the failure to communicate those decisions was an
infringement of Articles 1 and 4 of Decision No 3052/95, and accordingly
on 21 March 2005 sent a letter of formal notice asking the Spanish authorities
to clarify the matter.
26 The Commission was not satisfied with the
responses of the Spanish authorities and sent on 10 April 2006 to the Kingdom
of Spain a reasoned opinion, requesting that the necessary measures for
compliance be taken within a period of two months from the date of receipt of
the opinion.
27 Since the Spanish authorities do not
accept that the Commission’s criticism is well founded, the Commission has
brought this action.
The alleged failure to fulfil obligations under Articles 28 EC and 30
EC
Arguments
of the parties
28 The Commission claims that there is at
present no harmonisation at Community level either as regards herbs and herbal
extracts used in the composition of food supplements or as regards the
classification of products based on medicinal herbs as medicinal products or
food supplements. The Commission states in particular that Directive 2002/46/EC
of the European Parliament and of the Council of 10 June 2002 on the
approximation of the laws of the Member States relating to food supplements (OJ
2002 L 183, p. 51) postponed to a later stage the adoption of
specific rules concerning nutrients, other than vitamins and minerals, or other
substances with a nutritional or physiological effect, such as various herbs
and herbal extracts.
29 In the absence of such harmonisation,
products based on medicinal herbs lawfully marketed in one Member State ought,
as a general rule, to move freely pursuant to the principle of the free
movement of goods set out in Article 28 EC, unless it is properly demonstrated
that they carry a risk to human health, in accordance with Article 30 EC.
30 First, the Commission claims that the
Spanish authorities have adopted a consistent administrative practice, which
involves the systematic classification of products based on medicinal herbs
which are not listed in the annex to the 1973 Order as medicinal products by
function, without first submitting each of those products to detailed analysis,
and, consequently, in the absence of marketing authorisation, the withdrawal of
those products from the Spanish market.
31 However, according to the Court’s
case-law, in order to determine whether or not a product is a medicinal product
by function, it is appropriate to have regard to its composition, its
pharmacological properties, the manner in which it is used, the extent of its
distribution, its familiarity to consumers and the risks which its use may
entail. Products can be described as medicinal products by function only on a
case‑by‑case basis, taking account of their pharmacological properties.
32 Accordingly, the mere presence in a
product lawfully produced or marketed in another Member State of medicinal
herbs not listed in the annex to the 1973 Order is not a criterion which can
justify treating such a product as a medicinal product and withdrawing it from
the Spanish market in the absence of marketing authorisation.
33 Consequently, the practice of the
Spanish authorities is a measure having equivalent effect to a quantitative
restriction, prohibited by Article 28 EC.
34 The Commission does not accept the
assertion by the Kingdom of Spain that, before the decision to withdraw a
product from the market is taken, a detailed examination, product by product,
is carried out. The Commission claims, first, that the reality of the practice
complained of is clear from the complaints submitted to it by businesses whose
products based on medicinal herbs have been withdrawn from the market, from the
Report on the marketing of various products based on medicinal herbs (Informe
sobre la comercializatión de diversos productos a base de plantas
medicinas) dated 26 March 2004 issued by AEMPS, and from the court judgments
rejecting actions brought by those businesses against the decisions to withdraw
their products from the market, in particular the judgment of the contentious
administrative division of the Audiencia Nacional of 30 June 2004 in relation
to the action brought by Tregor. The Commission emphasises, secondly, that the
Kingdom of Spain makes no reference to any individual withdrawal decisions and the
reasons for them, with the result that the Kingdom of Spain has not proved that
a case‑by‑case examination is made prior to the classification of a product
containing medicinal herbs as a medicinal product.
35 Secondly, in the Commission’s opinion,
the practice of the Spanish authorities cannot be justified on the basis of
Article 30 EC.
36 Contrary to the requirements laid down
by the Court’s case-law in relation to Article 30 EC, the systematic nature of
the Spanish administrative practice makes it impossible either to identify or
evaluate any actual risk to public health, when there is no thorough
evaluation, on a case‑by‑case basis, of the negative effects on human health
which consumption of the products in question might entail. The practice is
based on a presumption of danger going beyond what is necessary and
proportionate for the protection of public health.
37 First, the Kingdom of Spain denies that
there is a practice such as described by the Commission.
38 The decision to submit the marketing of
a product containing medicinal herbs to the rules applicable to medicinal
products is the result of an analysis of that product in relation to its
composition, the properties which the producer associates with it and the form
in which it is offered for sale. As part of that analysis, investigation is
also made into whether herbs prohibited under the 2004 Order or authorised
under the 1973 Order are constituents of the product. Only when, as a result of
that analysis, the conclusion is unavoidable that the marketing of the product
in question ought to have been monitored in the way required for the marketing
of medicinal products is that product withdrawn from the market.
39 Such a withdrawal is therefore not
systematic, but is prompted by the dangerousness of the product examined. There
are moreover many herbal products marketed freely in Spain which are
categorised as food supplements.
40 As regards, more particularly, the
products the withdrawal of which from the market led to the complaints which
initiated the pre-litigation procedure, the Kingdom of Spain states that a
detailed individual analysis of each of those products was carried out, which
consisted of identifying the substances present as constituents and also examining
their presentation and the properties associated with those substances. The
principal objective of that analysis was to evaluate both the capacity of those
products to correct or modify physiological functions and the risks to health,
actual or potential, entailed in their consumption.
41 In respect of each of the products
concerned, the withdrawal decision was not based exclusively on the fact that
medicinal herbs not listed in the annex to the 1973 Order were among its
constituents, but was founded on the results of that analysis.
42 According to the Kingdom of Spain, all
the products the withdrawal of which from the market led to the complaints
which initiated the pre-litigation procedure fell under the harmonised
definition of ‘herbal medicinal product’ within the meaning of Directive
2001/83, since they were either products presented as associated with
therapeutic, curative or preventive properties in respect of human health, or
products associated with purposes unrelated to health, but in any event likely
to cause in human beings some modification of physiological functions by
pharmacological action.
43 All those products contained one or
more substances derived from medicinal herbs whose possible effects on human
health and medical uses regarded by other European health authorities as
acceptable had been established by a scientific study by AEMPS.
44 Furthermore, most of those substances
are to be found in a provisional list of medicinal herbs dated 11 January 2007
and published by the Working Party on Community Monographs and Community Lists
of the Committee on Herbal Medicinal Products set up by Article 16h of
Directive 2001/83, which shows that that committee has already taken the
decision to classify those substances as medicinal herbs. It follows, according
to the Kingdom of Spain, that products composed of those substances necessarily
fall under the definition of ‘herbal medicinal product’ within the meaning of
that directive.
45 The Kingdom of Spain adds that, under Article
2(2) of Directive 2001/83, in cases of doubt, when a product may fall within
the definition of a medicinal product within the meaning of that directive and
also within the definition of a product covered by other Community legislation,
classification as a medicinal product must prevail.
46 The Kingdom of Spain considers that the
legislation and practice in Spain are consistent with the Court’s case-law on
medicinal products, from which it is clear in particular that the national
authorities have some discretion in relation to the classification of a product
as a medicinal product.
47 Secondly, if the Court were to consider
that the practice complained of by the Commission exists, that the products
withdrawn from the market were not medicinal products, and that those
withdrawals constituted a restriction on the free movement of goods within the
meaning of Article 28 EC, the Kingdom of Spain contends that such a withdrawal
is justified by the exception, provided for by Article 30 EC, concerning the
protection of public health.
48 First, in the current state of
scientific research, there is uncertainty as regards the harmlessness of the
products withdrawn from the market that justifies their withdrawal under the
precautionary principle, in accordance with the case-law of the Court and in
particular Case C‑24/00 Commission v France [2004] ECR I‑1277,
paragraph 56.
49 Products based on medicinal herbs are
almost always products the safety of which has not been thoroughly examined. On
many occasions, preparations based on medicinal herbs have had undesirable, and
sometimes serious effects. Moreover, there is a risk that such preparations may
interact with other medicinal products.
50 The mere presence in a product of
substances which present a risk to public health undeniably constitutes a
reason for the health authorities, on the basis of available scientific and
technical knowledge, to withdraw that product from the market.
51 The Kingdom of Spain considers moreover
that the analysis made by the Court in Case C‑150/00 Commission v Austria
[2004] ECR I‑3887 is not transposable to the present case. In that judgment,
which concerned a consistent and generalised practice of classifying foodstuffs
containing vitamins as medicinal products, the Court’s finding that there was a
failure to fulfil obligations was based on the fact that as a general rule
vitamins are harmless. On the other hand, in the present case, most of the
products concerned could have serious consequences for human health, especially
since the Commission has provided no data to suggest that the harmlessness of
those products has been established.
52 Secondly, a decision to withdraw goods
from the market is always taken by the Spanish authorities on an ad hoc, case‑by‑case,
basis, taking into account a complex set of circumstances, in which the role of
the 1973 Order is secondary, and the undertakings concerned always have the
possibility of bringing proceedings before the courts which would review all
aspects of the withdrawal decision. Furthermore, it is always open to those
undertakings to apply for a marketing authorisation as a medicinal product.
Consequently, the withdrawal decisions appear proportionate.
53 Alternatively, the Kingdom of Spain
considers that the withdrawal from the market of the products concerned was
justified by the overriding requirement of consumer protection, recognised in
the case-law of the Court.
Findings
of the Court
Whether
there is an administrative practice
54 It is settled case-law that an
administrative practice can be made the object of an action for failure to
fulfil obligations when it is, to some degree, of a consistent and general
nature (see, inter alia, Case C‑135/05 Commission v Italy [2007]
ECR I‑3475, paragraph 21).
55 It is clear from the Commission’s
pleadings that its criticism of the Spanish authorities relates to an
administrative practice which consists of systematically classifying as
medicinal products by function and, in the absence of marketing authorisation,
withdrawing from the Spanish market products based on medicinal herbs lawfully
produced and/or marketed as food supplements or dietary products in other
Member States, where, and solely because, the herbs they contain are not listed
in the annex to the 1973 Order.
56 The Kingdom of Spain contends that
there is no such administrative practice.
57 In that regard, first, the Kingdom of
Spain correctly submits that some of the products the withdrawal of which from
the Spanish market led to the complaints received by the Commission were not
withdrawn from the market for the reason that the medicinal herbs they
contained were not listed in the annex to the 1973 Order, but because those
medicinal herbs were listed in the annex to the 2004 Order. The latter annex,
which corresponds to the list referred to in Article 42(2) of Law
No 25/1990, refers to herbs whose toxicity in the opinion of the Spanish
authorities precludes their use in products other than medicinal products.
58 Accordingly, the withdrawal of such
herbal products follows from Article 42(2) of Law No 25/1990, read in
conjunction with the 2004 Order; those provisions of national law prohibit sale
to the public of those herbs and of preparations containing them other than as
medicinal products, because of their toxicity.
59 The Commission, which did not refer to
the 2004 Order either in the letter of formal notice, the reasoned opinion, or
its pleadings before the Court, does not claim that those provisions might be
incompatible with Community law.
60 Secondly, as is contended by the
Kingdom of Spain and confirmed by the judgment of the Audiencia Nacional of 30
June 2004 referred to in paragraph 34 of this judgment, the marketing of some
of the products based on medicinal herbs which are not listed in either the
annex to the 1973 Order or in the annex to the 2004 Order is not subject to
obtaining a marketing authorisation. It is clear from Article 1 of the 1973
Order that the marketing of preparations the constituents of which are
exclusively medicinal herbs, whole parts of such herbs, or crushed or ground
parts of such herbs, requires merely that those preparations be included in the
special register provided for by that order.
61 On the other hand, as regards other
products based on medicinal herbs not listed in the annex to the 1973 Order,
the reality and consistency of their systematic classification as medicinal
products and the need to obtain marketing authorisation if they are to be
marketed are established in the AEMPS report referred to in paragraph 34 of
this judgment. It is clear from that report that, apart from products based on
herbs traditionally considered to be medicinal and listed in the annex to the
1973 Order, products based on medicinal herbs are subject to the legislation on
medicinal products as regards their manufacture, their marketing, their
distribution and their sale.
62 That practice has been validated by the
national courts. In its judgment of 30 June 2004 referred to in paragraph 34 of
this judgment, the contentious administrative division of the Audiencia
Nacional made the finding that the classification of products based on
medicinal herbs marketed by Trégor as medicinal products was a consequence of
‘the fact that they contain herbs not listed in the annex to the 1973 Order’.
63 It must moreover be observed, first,
that the Kingdom of Spain has provided no evidence, such as individual
withdrawal decisions, to establish that any case‑by‑case examination, going
beyond a simple check whether the medicinal herbs contained in a given product
are or are not listed in either the annex to the 1973 Order or in the annex to
the 2004 Order, is carried out prior to the classification of that product as a
medicinal product. Next, the Kingdom of Spain has offered no instance of a
product based on medicinal herbs not listed in the annex to the 1973 Order
which is marketed freely. Lastly, it is clear that the Kingdom of Spain does
not contend that, between 2004 and the date of expiry of the period allowed in
the reasoned opinion, there was any change in the national legislation or in
the practices of AEMPS.
64 It must be added that the Kingdom of
Spain does not submit, and it is in no way suggested in the court file, that
the practice of systematically classifying products based on medicinal herbs
not listed in the Annex to the 1973 Order as medicinal products does not apply
to products lawfully produced and marketed in other Member States.
Consequently, it is clear that no distinction is made on the basis of the
origin of the products.
65 It follows from the above
considerations that, when the period allowed in the reasoned opinion expired,
the administrative practice complained of was established in relation to
products based on medicinal herbs which are not listed in either the annex to
the 1973 Order or in that of the 2004 Order, other than preparations the
constituents of which are exclusively medicinal herbs or whole parts of such
herbs, or crushed or ground parts of such herbs, and that that practice had a
sufficient degree of consistency and generality to justify an action for
failure to fulfil obligations.
66 In the remainder of this judgment,
reference to products based on medicinal herbs not listed in the Annex to the
1973 Order will refer exclusively to those products based on medicinal herbs
which are not listed either in the annex to the 1973 Order or in the annex to
the 2004 Order, other than preparations the constituents of which are
exclusively medicinal herbs or whole parts of such herbs, or crushed or ground
parts of such herbs.
Classification
as medicinal product by function
67 It is clear from Articles 2 and 6(1) of
Directive 2001/83 that no medicinal product manufactured industrially can be
placed on the market of a Member State unless a marketing authorisation has
been issued by the competent authority of that Member State or unless an
authorisation has been issued in accordance with Regulation No 2309/93.
68 It follows that, if a product manufactured
industrially comes within the definition of medicinal product in Article 1(2)
of Directive 2001/83, the obligation on the importer of that product to obtain
a marketing authorisation in accordance with that directive prior to marketing
it in the Member State of importation cannot, in any event, constitute a
restriction on trade between Member States prohibited by Article 28 EC (Case C‑319/05
Commission v Germany [2007] ECR I‑9811, paragraph 35).
69 Moreover, as the harmonisation of
national legislation in relation to the production and distribution of
medicinal products currently stands, the fact that a product is classified as a
foodstuff in another Member State cannot prevent it from being classified as a
medicinal product in the Member State of importation, if it displays the
characteristics of such a product (see Joined Cases C‑211/03, C‑299/03 and C‑316/03
to C‑318/03 HLH Warenvertrieband Orthica [2005] ECR I‑5141, paragraph
56, and Commission v Germany, paragraphs 36 and 37).
70 As regards, more particularly, products
based on medicinal herbs, as stated by the Commission, in the Community
legislation there is no harmonisation as regards classification of such
products either as medicinal products or as food products.
71 The Court must therefore determine,
first, whether products based on medicinal herbs not listed in the annex to the
1973 Order are necessarily medicinal products by function within the meaning of
Article 1(2)(b) of Directive 2001/83.
72 In order to determine whether a product
falls under the definition of medicinal product by function within the meaning
of Directive 2001/83, the national authorities, subject to review by the
courts, must decide on a case‑by‑case basis, taking account of all the
characteristics of the product, in particular its composition, its
pharmacological, immunological and/or metabolic properties, to the extent to
which they can be established in the present state of scientific knowledge, the
manner in which it is used, the extent of its distribution, its familiarity to
consumers and the risks which its use may entail (HLH Warenvertrieb and
Orthica, paragraph 51; Commission v Germany, paragraph 55,
and Case C‑140/07 Hecht-Pharma [2009] ECR I‑0000, paragraph 32).
73 As clarified by the Commission itself,
medicinal herbs are plants which, because of their properties and physiological
effects, can be used as ingredients in medicinal products or in other types of
products, such as food supplements.
74 However, the mere fact that one or more
medicinal herbs are among the constituents of a product is not sufficient to
permit the conclusion that that product contributes to restoring, correcting or
modifying physiological functions by exerting a pharmacological, immunological
or metabolic action or to making a medical diagnosis, within the meaning of
Article 1(2)(b) of Directive 2001/83.
75 It is possible that, having regard, in
particular, to the small amount of the active substance contained in it and/or
the manner in which it is used, a product based on medicinal herbs will have no
effect on physiological functions or that its effects will not suffice for it
to be a medicinal product by function (see, by analogy, as regards preparations
containing vitamins or minerals, Commission v Austria, paragraph
63; see also, to that effect, Hecht-Pharma, paragraph 42). In that
regard, the Court has held that substances which, while having an effect on the
human body, do not significantly affect the metabolism and thus do not strictly
modify the way in which it functions should not be classified as medicinal
products by function (see Commission v Germany, paragraph 60, and
Hecht-Pharma, paragraph 41).
76 A consequence of the Spanish
administrative practice complained of, in so far as it is applied
systematically to all products based on medicinal herbs not listed in the annex
to the 1973 Order, may therefore be that some of those products are classified
as medicinal products, even when they are not capable of restoring, correcting
or modifying human physiological functions.
77 That conclusion is not invalidated by
the results of the scientific study referred to in paragraph 43 of this
judgment, from which it emerges, according to the Kingdom of Spain, that all
the products of Ynsadiet, Tregor and Taxón withdrawn from the market in 2002
and 2003 contained herbs which can be harmful to human health. As was stated by
the Advocate General in points 40 to 42 of his Opinion, that scientific study
relates to the harmfulness of the medicinal herbs themselves, but not to the
pharmacological, immunological or metabolic properties of the products
withdrawn from the market or to the risks which their use might entail.
Furthermore, that study relates to only 34 herbs, whereas the practice
complained of is applied to all products based on medicinal herbs not listed in
the annex to the 1973 Order, the number of which is potentially unlimited.
78 The Court must also reject the argument
of the Kingdom of Spain that, in accordance with Article 2(2) of Directive
2001/83, and given the doubt on the matter, products based on medicinal herbs
other than those listed in the annex to the 1973 Order must be classified as
medicinal products by function.
79 Article 2(2) of Directive 2001/83 must
be interpreted as meaning that that directive does not apply to a product in
respect of which it has not been scientifically established that it is a
medicinal product by function, without its being possible to exclude that
possibility (Hecht-Pharma, paragraph 29). Moreover, given the systematic
nature of the Spanish administrative practice, it is possible that products
based on medicinal herbs other than those listed in the annex to the 1973 Order
will be classified as medicinal products by function although that is clearly
not the case.
80 It follows from the foregoing that the
Spanish administrative practice complained of in the present case cannot be
defended on the basis of Directive 2001/83.
Whether
there is a restriction
81 It is accordingly necessary to
consider, secondly, whether the requirement of marketing authorisation for
products based on medicinal herbs not listed in the annex to the 1973 Order,
imposed by the Spanish administrative practice, constitutes a measure having
equivalent effect to a quantitative restriction on imports, prohibited by
Article 28 EC.
82 The prohibition on measures having
equivalent effect to quantitative restrictions set out in Article 28 EC covers
all measures which are capable of hindering, directly or indirectly, actually
or potentially, intra-Community trade (see, in particular, Case 8/74 Dassonville
[1974] ECR 837, paragraph 5; Case C‑192/01 Commission v Denmark
[2003] ECR I‑9693, paragraph 39; Commission v France, paragraph
22; and Commission v Germany, paragraph 80).
83 In the present case, the Spanish
administrative practice creates an obstacle to intra-Community trade in so far
as a product based on medicinal herbs not listed in the annex to the 1973
Order, lawfully produced and/or marketed in another Member State as a food
supplement or dietary product, can be marketed in Spain only after going
through the marketing authorisation procedure (see, by analogy, Commission
v Austria, paragraph 82, and Commission v Germany,
paragraph 81).
84 The Spanish administrative practice
complained of in the present case therefore constitutes a measure having
equivalent effect to a quantitative restriction, within the meaning of Article
28 EC.
Whether
there is justification
85 It must therefore be determined,
thirdly, whether, as contended by the Kingdom of Spain, the practice in
question can be justified by the need to protect human health, referred to in
Article 30 EC, or by the overriding requirement of consumer protection,
established in the Court’s case-law.
86 In accordance with the Court’s
case-law, it is for the Member States, in the absence of harmonisation and to
the extent that uncertainties continue to exist in the current state of
scientific research, to decide on the level of protection of human health and
life they wish to ensure and on whether to require prior authorisation for the
marketing of foodstuffs, always taking into account the requirements of the
free movement of goods within the Community (see Commission v Denmark,
paragraph 42; Commission v France, paragraph 49; and Commission
v Germany, paragraph 86).
87 It follows that Community law does not
therefore, in principle, preclude a Member State from prohibiting, unless there
is prior authorisation, the marketing of foodstuffs to which nutrients, such as
vitamins or minerals other than those whose use is lawful under Community
legislation, have been added (Commission v Denmark, paragraph 44;
Commission v France, paragraph 51; and Commission v Austria,
paragraph 87).
88 However, in exercising their discretion
relating to the protection of public health, the Member States must comply with
the principle of proportionality. The means which they choose must therefore be
confined to what is actually necessary to ensure the safeguarding of public
health or to meet overriding requirements such as, for example the protection
of consumers; they must be proportional to the objective thus pursued, which
could not have been attained by measures which are less restrictive of intra-Community
trade (see Commission v Denmark, paragraph 45; Commission
v France, paragraph 52; Commission v Austria, paragraph
88; and Commission v Germany, paragraph 87).
89 Furthermore, since Article 30 EC
provides for an exception, to be interpreted strictly, to the rule of free
movement of goods within the Community, it is for the national authorities
which invoke it to show in each case, in the light of national nutritional
habits and in the light of the results of international scientific research,
that their rules are necessary to give effective protection to the interests
referred to in that provision and, in particular, that the marketing of the
products in question poses a real risk to public health (Commission v Denmark,
paragraph 46; Commission v France, paragraph 53; Commission
v Austria, paragraph 89; and Commission v Germany,
paragraph 88).
90 That case-law, which was developed in
relation to foodstuffs enriched with nutrients such as vitamins and minerals,
is also applicable to products based on medicinal herbs intended for human
consumption.
91 In the present case, while, as was
stated in paragraph 87 of this judgement, Community law does not, in principle,
preclude a system of prior authorisation, it remains however clear that the
issuing of marketing authorisation pursuant to Article 8 of Directive 2001/83
is subject to particularly strict requirements (Commission v Germany,
paragraph 89). In that regard, it must be observed that the Kingdom of Spain
has not contended that all or some of the products withdrawn from the market in
2002 and 2003 could take advantage of a simplified registration procedure such
as that established by Articles 16a to 16i of that directive for traditional
herbal medicinal products.
92 In those circumstances, the obligation
to obtain marketing authorisation before being able to market products based on
medicinal herbs on Spanish territory may be regarded as in accordance with the
principle of proportionality only if it is actually necessary, in each case, to
safeguard public health (see, to that effect, Commission v Austria,
paragraph 94, and Commission v Germany, paragraph 90).
93 Such a restriction on the free movement
of goods must therefore necessarily be based on a detailed assessment, on a case‑by‑case
basis, of the risk alleged by the Member State invoking Article 30 EC (see, to
that effect, Commission v Austria, paragraph 96, and Commission
v Germany, paragraph 91).
94 However, the criterion used by the
Spanish authorities for requiring marketing authorisation, namely the fact that
the medicinal herb on which the manufactured product is based is not listed in
the Annex to the 1973 Order, does not allow, on the basis of the most recent
scientific data, account to be taken of the actual risk to public health
presented by such products.
95 It follows from the foregoing that the
Spanish administrative practice complained of in this plea does not meet the
requirements of Community law, as set out in the case-law of the Court referred
to in paragraphs 89 to 93 of this judgment, and in particular the requirement
that there be a detailed assessment, on a case‑by‑case basis, of the risk to
public health which the marketing of a product based on medicinal herbs might
entail.
96 It cannot be argued that traders have
the option of applying for the inclusion of the herb contained in their product
in the annex to the 1973 Order. As clarified by the Kingdom of Spain itself, a
trader can have a herb included in that annex only if he proves that it has
been traditionally used. The fact that a product contains a medicinal herb
which has not been traditionally used does not necessarily imply that that
product presents a risk to public health.
97 Moreover, as regards effective consumer
protection, to which the Kingdom of Spain also refers, it is naturally
legitimate to seek to ensure that consumers are properly informed about the
products which they consume (Commission v France, cited above,
paragraph 74).
98 However, the Kingdom of Spain has not
explained why appropriate labelling, informing consumers of the nature, the
ingredients and the characteristics of products based on medicinal herbs, would
not adequately meet that objective where the classification of those products
as medicinal products is not justified on grounds of public health (see, by
analogy, Commission v France, paragraph 75).
99 Consequently, the first complaint,
alleging infringement of Articles 28 EC and 30 EC, is well founded.
The alleged failure to fulfil obligations under Articles 1 and 4 of
Decision No 3052/95
Arguments
of the parties
100 The Commission considers that the Kingdom of Spain
ought to have notified it of the market withdrawal measures taken in 2002 and
2003 in respect of products of Ynsadiet, Tregor and Taxón, within a period of
45 days from the date when each of those measures was taken. By failing to do
so, the Kingdom of Spain has infringed Articles 1 and 4 of Decision
No 3052/95.
101 The Commission claims that the products based on
medicinal herbs withdrawn from the market by the Spanish authorities were
lawfully marketed in other Member States, generally as food supplements or
dietary products.
102 The Commission claims that the Spanish authorities
had been made aware of that fact. First, the undertakings whose products were
involved had stated to those authorities that some of those products were
lawfully produced or marketed in other Member States. Secondly, the Commission
had previously noted that fact in its reasoned opinion sent to the Kingdom of
Spain, which did not challenge the truth of the matter.
103 The Kingdom of Spain contends, first, that some of
the products withdrawn from the market were manufactured in Spain and that, on
no occasion did Ynsadiet, Tregor and Taxón submit to the Spanish authorities
documents establishing that those products were lawfully marketed in another
Member State. Second, the defendant Member State maintains that it was not
informed that some of the products withdrawn from the market had been imported
from another Member State where they were lawfully produced. Also, the
Commission has not so far provided any detailed information on that matter.
104 Consequently, in accordance with Article 1 of
Decision No 3052/95, since the procedure laid down by that decision was not
applicable, the Kingdom of Spain was not obliged to notify the abovementioned
withdrawal decisions.
Findings
of the Court
105 Under Article 1 of Decision No 3052/95,
‘[w]here a Member State takes steps to prevent the free movement or placing on
the market of a particular model or type of product lawfully produced or
marketed in another Member State, it shall notify the Commission accordingly
where the direct or indirect effect of the measure is’, in particular, ‘a
general ban on the goods’, ‘a refusal to allow the goods to be placed on the
market’ or ‘withdrawal of the goods from the market’.
106 Decision No 3052/95 defines ‘measure’ as any
measure taken by a Member State, except for judicial decisions, which has the
effect of restricting the free movement of goods lawfully produced or marketed
in another Member State, regardless of its form or the authority from which it
emanates (Joined Cases C‑388/00 and C‑429/00 Radiosistemi [2002] ECR I‑5845,
paragraph 68, and Case C‑432/03 Commission v Portugal [2005] ECR
I‑9665, paragraph 57).
107 The wording ‘a particular model or type of product
lawfully produced or marketed in another Member State’ of Article 1 of Decision
No 3052/95 indicates that the obligation to notify laid down by that
provision falls on the Member State concerned not only where products produced
or marketed in another Member State are withdrawn from the market, but also
where products produced in its own territory are withdrawn from the market
while products of the same model or of the same type are lawfully produced
and/or marketed in another Member State and would also be subject to withdrawal
from the market if they were imported into the Member State concerned.
108 That interpretation is also consistent with the
purpose of Decision No 3052/95. The mere existence of legislation or of a
practice in a Member State applicable without distinction to domestic and
imported products is likely to deter traders from importing into that Member
State goods lawfully produced or marketed in another Member State and therefore
has the effect of restricting the free movement of those goods.
109 However, the obligation to notify laid down in
Article 1 of Decision No 3052/95 falls on the Member State concerned only
if it knows, or could reasonably be expected to know, that the measure adopted
by it has the effect of hindering the marketing in its territory of products
lawfully produced or marketed in another Member State. The onus is on the
Commission to provide evidence to that effect.
110 In the present case, it must therefore be
ascertained, first, whether, when the Spanish authorities withdrew in 2002 and
2003 the products of Ynsadiet, Tregor and Taxón from the Spanish market, there
were products based on medicinal herbs not listed in the annex to the 1973
Order that were lawfully produced and/or marketed in another Member State and,
secondly, whether the Spanish authorities were aware of that fact.
111 In that regard, the Kingdom of Spain contends that
it was the Commission itself, in the reasoned opinion, that informed it that
some of the products marketed by Ynsadiet in Spain and withdrawn from the
Spanish market had been lawfully produced by Biover NV in Belgium, where the products
were certified by the Belgian Ministry of Health and Social Affairs.
112 However, as the Commission correctly points out,
immediately after the inspection which was carried out on 15 and 16 July 2003
at the premises of Ynsadiet, that company informed the Spanish authorities that
the products in the Biover range were imported from Belgium, where they were
lawfully produced and marketed, and repeated that information in its action
against the decision to withdraw its products from the Spanish market.
113 The Commission has also correctly stated that the
Belgian origin of those products was not disputed by the Spanish authorities,
since it was mentioned in a fax sent on 21 November 2003 by AEMPS to Ynsadiet.
114 It must also be observed that the objective of the
procedure for the exchange of information between the Member States themselves
and the Commission established by Decision No 3052/95 is not to protect
the rights of any specific trader, but, as is clear from the fifth recital of
the preamble to that decision, to identify the problems encountered in the
implementation of the free movement of goods with a view to finding appropriate
solutions to them. Accordingly, when the Spanish authorities were informed that
products in the Biover range had been imported from Belgium, it was their duty,
if they considered the evidence that those products were lawfully produced
and/or marketed in Belgium to be insufficient, to check the facts with the
Belgian authorities, in accordance with the duty of genuine cooperation laid
down in Article 10 EC, and they could not take refuge behind any failings on
the part of Ynsadiet.
115 Consequently, the second ground of complaint, that
there was an infringement of Articles 1 and 4 of Decision No 3052/95, is
also well founded.
116 In light of all of the foregoing, it must be held
that:
– by withdrawing from the
market products based on medicinal herbs lawfully produced and/or marketed in
another Member State, under an administrative practice consisting in
withdrawing from the market any product containing medicinal herbs not included
either in the annex to the 1973 Order or in the annex to the 2004 Order, other
than a preparation the constituents of which are exclusively one or more
medicinal herbs or whole parts of such herbs, or crushed or powdered parts of
such herbs, on the ground that that product is deemed to be a medicinal product
marketed without the requisite marketing authorisation, and
– by not communicating that
measure to the Commission,
the Kingdom
of Spain has failed to fulfil its obligations under Articles 28 EC and 30 EC
and Articles 1 and 4 of Decision No 3052/95.
Costs
117 Under Article 69(2) of the Rules of Procedure, the
unsuccessful party is to be ordered to pay the costs if they have been applied
for in the successful party’s pleadings. Since the Commission has applied for
costs and the Kingdom of Spain has been unsuccessful, the Kingdom of Spain must
be ordered to pay the costs.
On those grounds, the Court (First Chamber) hereby:
1. – declares
that, by withdrawing from the market products based on medicinal herbs lawfully
produced and/or marketed in another Member State, under an administrative
practice consisting in withdrawing from the market any product based on
medicinal herbs not included either in the annex to the Ministerial Order on
the creation of a special register of medicinal herb-based preparations (Orden
Ministerial por la que se establece el registro especial para preparados a base
de especies vegetales) of 3 October 1973, as amended, or in the annex to the
Order SCO/190/2004 of the Ministry of Health and Consumer Affairs, establishing
the list of plants sale of which to the public is prohibited or restricted
because of their toxicity (Orden SCO/190/2004 por la que se establece la lista
de plantas cuya venta al público queda prohibida o restringida
por razón de su toxicidad) of 28 January 2004, other than a preparation the
constituents of which are exclusively one or more medicinal herbs or whole
parts of such herbs, or crushed or powdered parts of such herbs, on the ground
that that product is deemed to be a medicinal product marketed without the
requisite marketing authorisation, and
– by not communicating
that measure to the Commission of the European Communities,
the Kingdom of Spain has failed to fulfil its
obligations under Articles 28 EC and 30 EC and Articles 1 and 4 of Decision
No 3052/95/EC of the European Parliament and of the Council of 13 December
1995 establishing a procedure for the exchange of information on national
measures derogating from the principle of the free movement of goods within the
Community.
2. Orders the
Kingdom of Spain to pay the costs.
[Signatures]
* Language of the case: Spanish.