CELEX: 62007CJ0140
Directive 2001/83/EC
Articles 1(2) and 2(2)
Concept of ‘medicinal product by function’
Product in respect of which it has not been established that it is a medicinal product by function
Account taken of the content in active substances

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),
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’) and, in particular, Articles 1(2) and 2(2) thereof.
The reference has been made in the context of proceedings between Hecht-Pharma GmbH (‘Hecht-Pharma’) and the Staatliches Gewerbeaufsichtsamt
Lüneburg (Public Authority for the Monitoring of Commercial Activities, Lüneburg) concerning the classification of a product
called ‘Red Rice’ as a food additive or a medicinal product for the purposes of its marketing in German territory.

Legal framework

Community rules
Article 1(2) of Directive 2001/83, in its original version, provided that the term ‘medicinal product’ was to mean:
‘Any substance or combination of substances presented for treating or preventing disease in human beings.
Any 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 …’
The present version of Article 1(2) of Directive 2001/83 provides that the term ‘medicinal product’ means:
‘(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’.
Article 2(1) and (2) of Directive 2001/83 provides as follows:
‘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.’
Recitals 2, 3, 4 and 7 in the preamble to Directive 2004/27 state that:
‘(2)      The Community legislation so far adopted has made a major contribution to the achievement of the objective of the free and
safe movement of medicinal products for human use and the elimination of obstacles to trade in such products. However, in
the light of the experience acquired, it has become clear that new measures are necessary to eliminate the remaining obstacles
to free movement.
(3)      It is therefore necessary to align the national laws, regulations and administrative provisions which contain differences
with regard to the basic principles in order to promote the operation of the internal market while realising a high level
of human health protection.
(4)      The main purpose of any regulation on the manufacture and distribution of medicinal products for human use should be to safeguard
public health. However, this objective should be achieved by means which do not hinder the development of the pharmaceutical
industry or trade in medicinal products in the Community.
…
(7)      Particularly as a result of scientific and technical progress, the definitions and scope of Directive 2001/83/EC should be
clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products for human use. In
order to take account both of the emergence of new therapies and of the growing number of so-called “borderline” products
between the medicinal product sector and other sectors, the definition of “medicinal product” should be modified so as to
avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal
product, may also fall within the definition of other regulated products. This definition should specify the type of action
that the medicinal product may exert on physiological functions. This enumeration of actions will also make it possible to
cover medicinal products such as gene therapy, radiopharmaceutical products as well as certain medicinal products for topical
use. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to
apply. With the same objective of clarifying situations, where a given product comes under the definition of a medicinal product
but could also fall within the definition of other regulated products, it is necessary, in case of doubt and in order to ensure
legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition
of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, this Directive
should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation.’

National legislation
Pursuant to Paragraph 69(1) of the Arzneimittelgesetz (Law on medicinal products), the competent German authorities are to
take the necessary steps to eliminate infringements that have been confirmed or to prevent future infringements. They may,
in particular, prohibit the placing on the market of medicinal products in the absence of the necessary authorisation or registration
of such products.

The dispute in the main proceedings and the questions referred for a preliminary ruling
In September 2002, Hecht-Pharma, which operates a wholesale pharmaceutical business, marketed in Germany a product composed
of fermented red rice under the name ‘Red Rice 330 mg Kapseln [capsules]’.
The capsules were marketed in plastic bottles which stated on their labels, inter alia: ‘Red Rice 330 mg, food supplement
with fermented rice. One capsule corresponds to 1.33 mg of monacolin k’. The recommendations for use read as follows: ‘As
food supplement, 1 capsule 1 - 3 times daily’.
By decision of 19 December 2002, the Bezirksregierung Lüneburg (District Administration, Lüneburg) prohibited Hecht-Pharma
from marketing the product at issue in the main proceedings on the German market on the ground that it was a medicinal product
that required a marketing authorisation but had not obtained any such authorisation.
Hecht-Pharma lodged a complaint against that decision with the Bezirksregierung Lüneburg. Since its complaint was rejected
by decision of 11 June 2003, Hecht-Pharma brought an action against that decision before the Verwaltungsgericht (Administrative
Court), which dismissed the action by judgment of 28 April 2005.
In the view of the Niedersächsisches Oberverwaltungsgericht (Higher Administrative Court of Lower Saxony), which, by judgment
of 23 March 2006, dismissed the appeal which Hecht-Pharma had brought before it against the judgment of the Verwaltungsgericht,
the contested prohibition on marketing was justified by the fact that the product at issue in the main proceedings was a medicinal
product.
The Niedersächsisches Oberverwaltungsgericht held that the legislation on medicinal products was applicable on the ground
that the product in question could come within the scope of the definition of a medicinal product by function. It contained
significant levels of monacolin k. That active substance is synonymous with lovastatin, an inhibitor of cholesterol synthesis
which is contained, as an active substance, in a number of prescription medicinal products.
The Niedersächsisches Oberverwaltungsgericht concluded that the product at issue in the main proceedings was liable to lower
excessively high cholesterol levels and therefore contribute to the realisation of a therapeutic objective. It added that
inhibitors of cholesterol synthesis could also have serious, undesirable side-effects on the muscles and kidneys.
In the view of the Niedersächsisches Oberverwaltungsgericht, Hecht-Pharma could not rely on the fact that, having regard to
the recommended dose, the product at issue in the main proceedings could not exert a pharmacological action. It held that
it could not be concluded from the fact that the recommended dose amounts to a daily consumption of 1.33 to 4 mg of monacolin
k, which is low in comparison with the daily consumption of 10 to 80 mg recommended for lovastatin, that monacolin k had no
pharmacological effect.
The Niedersächsisches Oberverwaltungsgericht added that, even though the recommended daily dose represented a low level of
consumption of monacolin k in comparison with the amount contained in prescription medicinal products, account had to be taken
of the fact that preparations marketed as food supplements are as a rule taken unsupervised and in greater quantities than
the recommended dose.
In addition, the Niedersächsisches Oberverwaltungsgericht pointed out that, since no pharmacological action had been demonstrated
with certainty, the rule of doubt laid down in Article 2(2) of Directive 2001/83 ought to be applied. The application of that
provision was not subject to the condition that the criteria governing the definition of a medicinal product be satisfied.
It was sufficient that the product could come within the scope of the definition of a medicinal product.
Hecht-Pharma appealed on a point of law against the judgment of the Niedersächsische Oberverwaltungsgericht.
Having taken the view that resolution of the dispute called for an interpretation of Community law, the Bundesverwaltungsgericht
(Federal Administrative Court) decided to stay the proceedings and to refer the following questions to the Court for a preliminary
ruling:
‘1.      Does the rule of doubt in Article 2(2) of Directive 2001/83 … mean that Directive 2001/83 … applies to a product which could
possibly be classified as a medicinal product but whose quality as a medicinal product has not been positively determined?
What degree of probability, and hence what degree of elucidation of the facts, may be required in order to justify the application
of Directive 2001/83 …?
2.      Can a product which is not a medicinal product by presentation be regarded as a medicinal product by function within the meaning
of Article 1(2) of Directive 2001/83 … because of a component which can produce physiological changes in a certain dosage
but whose dosage in the product to be assessed – if used as intended – is too low for that? Is this question to be allocated
to the criterion of “pharmacological action” or the criterion of “modifying physiological functions” in human beings?
3.      Are the characteristics of “the manner in which it is used, the extent of its distribution, its familiarity to consumers and
the risks which its use may entail” (judgment in [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 51]) stated in the case-law of the Court of Justice to be relevant, in addition to the pharmacological
qualities, to classification as a medicinal product still relevant following the new definition of a medicinal product introduced
by Directive 2004/27 …?’

The questions referred to the Court

The first question
In its first question, the national court asks, essentially, whether Article 2(2) of Directive 2001/83 must be interpreted
as meaning that that directive applies to a product in respect of which it has not been established that it is a medicinal
product by function, without its being possible to exclude that possibility. It also seeks to determine, if need be, what
degree of probability, and hence what degree of elucidation of the facts, is required in order to justify the application
of Directive 2001/83.
First of all, it should be noted that both Article 2 of Directive 2001/83, in its original version, and Article 2(1) of Directive
2001/83 provide, essentially, that that directive applies to medicinal products for human use intended to be placed on the
market in Member States and manufactured industrially.
The scope of Directive 2001/83 is thus limited to industrially-produced medicinal products, to the exclusion of products which
do not fall under one or other of the definitions of a medicinal product contained in Article 1(2)(a) and (b) of that directive.
That conclusion is not invalidated by Article 2(2) of Directive 2001/83.
It is clear from recital 7 in the preamble to Directive 2004/27 that Article 2(2) was inserted into Directive 2001/83 in order
to make clear that when a product falls within both the definition of a medicinal product and that of other regulated products,
it must be made subject to the provisions of Directive 2001/83. Thus, Article 2(2) of Directive 2001/83 starts from the premise
that the product concerned satisfies the conditions for classification as a medicinal product (see, to that effect,
HLH Warenvertrieb and Orthica
, paragraphs 43 and 44).
It should be borne in mind in that regard that, contrary to the definition of medicinal product by presentation, the broad
interpretation of which is intended to protect consumers from products which do not have the effectiveness which they are
entitled to expect, the definition of medicinal product by function is designed to cover products the pharmacological properties
of which have been scientifically observed and which are genuinely designed to make a medical diagnosis or to restore, correct
or modify physiological functions (Case C‑319/05
Commission
v
Germany
[2007] ECR I-9811, paragraph 61).
Thus, Directive 2001/83 does not apply to a product in respect of which it has not been established that it is a medicinal
product within the meaning of Article 1(2)(b) of that directive, that is to say, a product in respect of which it has not
been scientifically established that it is capable of restoring, correcting or modifying physiological functions by exerting
a pharmacological, immunological or metabolic action, or that it may be used to make a medical diagnosis.
That interpretation is corroborated by the case-law to the effect that the interpretation of the provisions of Directive 2001/83
– which is intended, in addition to protecting human health, to safeguard the free movement of goods within the Community
– cannot result in obstacles to the free movement of goods which are entirely disproportionate to the pursued aim of protecting
health (see, to that effect,
Commission
v
Germany
, paragraphs 62 and 71).
Moreover, it must be added that that interpretation does not cast doubt on the case-law to the effect that, as Community law
stands, it is still possible that differences will continue to exist between Member States in the classification of products
as medicinal products or as foodstuffs. It thus cannot be ruled out that one Member State may consider it established that
a product is a medicinal product by function whereas another Member State may take the view that, according to current scientific
knowledge, it has not been proved that that product is a medicinal product by function (see, to that effect,
HLH Warenvertrieb and Orthica
, paragraph 56).
Consequently, the answer to the first part of the first question is that 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.
In the light of that answer, there is no need to reply to the second part of the first question.

The third question
In its third question, which it is appropriate to answer before the second, the national court seeks to ascertain whether,
following the amendment of the definition of a medicinal product by Directive 2004/27, Article 1(2)(b) of Directive 2001/83
must be interpreted as meaning that the characteristics of the manner in which a product is used, the extent of its distribution,
its familiarity to consumers and the risks which its use may entail, laid down in the case-law of the Court, are still relevant
in determining whether that product comes within the definition of a medicinal product by function.
In its case-law prior to the amendment of Directive 2001/83 by Directive 2004/27, the Court indicated that, for the purpose
of determining whether a product falls within the definition of a medicinal product by function, the national authorities,
acting under the supervision of 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 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, and
Commission
v
Germany
, paragraph 55).
As is apparent from recital 7 in the preamble thereto, the purpose of the amendments made by Directive 2004/27 to the definition
of a medicinal product is to take account of the emergence of new therapies and of the growing number of so-called ‘borderline’
products. Also, in order to avoid doubts as to the applicable rules, the definition was made more precise and now specifies
the type of action – pharmacological, immunological or metabolic – which a medicinal product must exert with a view to restoring,
correcting or modifying human physiological functions.
That level of precision may have seemed necessary to the Community legislature inasmuch as physiological effect is not specific
to medicinal products but is also among the criteria used for the definition of food supplements (
Commission
v
Germany
, paragraph 63).
By contrast, there is nothing in the amendments made to the definition of a medicinal product by Directive 2004/27 to indicate
an intention to modify the criteria laid down in the case-law other than the need, in future, to take account of the immunological
and metabolic properties of a product, in addition to its pharmacological properties.
Rather, Article 2(2) of Directive 2001/83, inserted by Directive 2004/27, confirms the approach adopted by the case-law by
stating that ‘all its characteristics’ are to be taken into account in determining whether a product falls within the definition
of a medicinal product.
The answer to the third question is therefore that Article 1(2)(b) of Directive 2001/83 must be interpreted as meaning that
the characteristics of the manner in which a product is used, the extent of its distribution, its familiarity to consumers
and the risks which its use may entail are still relevant to determining whether that product falls within the definition
of a medicinal product by function.

The second question
In its second question, the national court asks, essentially, whether Article 1(2)(b) of Directive 2001/83 is to be interpreted
as meaning that a product may be classified as a medicinal product by function where, having regard to its composition – including
its content in active substances – and if used as intended, it is incapable of restoring, correcting or modifying physiological
functions. It also asks the Court whether the content in active substances of a product must be taken into account in assessing
the capacity of the product to exert a ‘pharmacological action’ or its capacity to modify ‘physiological functions in human
beings’.
First of all, it should be pointed out that it is apparent from paragraphs 32 and 33 of the present judgment that, for the
purpose of determining whether a product falls within the definition of a medicinal product by function within the meaning
of Directive 2001/83, the national authorities, acting under the supervision of 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
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.
It follows that products containing a substance having a physiological effect cannot automatically be classified as medicinal
products by function unless the competent administration has made an assessment, with due diligence, of each product individually,
taking account, in particular, of that product’s specific pharmacological, immunological or metabolic properties, to the extent
to which they can be established in the present state of scientific knowledge.
In that regard, it should be borne in mind that the capacity to restore, correct or modify physiological functions should
not lead to the classification as medicinal products by function of products 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 (see, to that effect,
Commission
v
Germany
, paragraph 60).
It follows that, apart from the case of substances or combinations of substances intended for the purpose of making a medical
diagnosis, a product cannot be regarded as being a medicinal product by function where, having regard to its composition –
including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting
or modifying physiological functions in human beings.
With regard to the second part of the national court’s second question, it must be pointed out that a product which may be
used by, or administered to, human beings with a view, in particular, ‘to restoring, correcting or modifying physiological
functions by exerting a pharmacological, immunological or metabolic action’ is a medicinal product by function within the
meaning of Article 1(2)(b) of Directive 2001/83.
The distinction which the national court makes between the capacity to exert a pharmacological action and the capacity to
modify physiological functions is therefore irrelevant for the purpose of classifying a product as a medicinal product by
function.
Consequently, the answer to the second question is that Article 1(2)(b) of Directive 2001/83 must be interpreted as meaning
that, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis,
a product cannot be regarded as a medicinal product within the meaning of that provision where, having regard to its composition
– including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting
or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.

Costs
Since 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:
1.
Article 2(2) 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, as amended by Directive 2004/27/EC of the European Parliament and of the Council
of 31 March 2004, must be interpreted as meaning that Directive 2001/83, as amended by Directive 2004/27, 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.
2.
Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27, must be interpreted as meaning that the characteristics
of the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which
its use may entail are still relevant to determining whether that product falls within the definition of a medicinal product
by function.
3.
Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27, must be interpreted as meaning that, apart from the
case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot
be regarded as a medicinal product within the meaning of that provision where, having regard to its composition – including
its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying
physiological functions by exerting a pharmacological, immunological or metabolic action.
[Signatures]
*
Language of the case: German.