CELEX: 62003CJ0039
Appeal
Directives 65/65/EEC and 75/319/EEC
Medicinal products for human use
Anorectics: amfepramone, clobenzorex, fenproporex, norpseudoephedrine, phentermine
Withdrawal of a marketing authorisation
Competence of the Commission
Conditions for withdrawal

By application lodged at the Court Registry on 3 February 2003, the Commission of the European Communities, in accordance
with Article 225 EC and the first paragraph of Article 56 of the Statute of the Court of Justice, brought an appeal against
the judgment of the Court of First Instance of 26 November 2002 in Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00,
T-137/00 and T-141/00
Artegodan and Others
v
Commission
[2002] ECR II-4945 (
the judgment under appeal), by which the Court of First Instance annulled, in so far as they related to the medicinal products marketed by the applicants
at first instance, Commission Decisions C(2000) 452, C(2000) 453 and C(2000) 608 of 9 March 2000 concerning the withdrawal
of marketing authorisations of medicinal products for human use containing phentermine (Decision C(2000) 452), amfepramone
(Decision C(2000) 453) and other
amphetamine-like anorectic substances,
inter alia
norpseudoephedrine, clobenzorex and fenproporex (Decision C(2000) 608) (
the decisions at issue).
Legal background
Directive 65/65/EEC
Article 3 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation
or administrative action relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by Council
Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22) (
Directive 65/65), lays down the principle that no medicinal product may be placed on the market of a Member State unless an authorisation
has been issued by the competent authority of that Member State in accordance with the directive or 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).
The first paragraph of Article 4 of Directive 65/65 provides that, in order to obtain an authorisation to place a medicinal
product on the market as provided for in Article 3, the person responsible for placing that product on the market is to make
application to the competent authority of the Member State concerned.  The third paragraph of Article 4 lists the particulars
and documents which are to accompany the application.  These include, in point 9, a summary of the product characteristics.
Article 4a of Directive 65/65 provides: The summary of the product characteristics referred to in point 9 of the [third] paragraph of Article 4 shall contain the
following information:1. Name of the [medicinal] product.2. Qualitative and quantitative composition in terms of the active ingredients and constituents of the excipient, knowledge
of which is essential for proper administration of the medicinal product; ...3. Pharmaceutical form.4. Pharmacological properties and, in so far as this information is useful for therapeutic purposes, pharmacokinetic particulars.5. Clinical particulars:5.1. therapeutic indications,5.2. contra-indications,5.3. undesirable effects (frequency and seriousness),5.4. special precautions for use,5.5. use during pregnancy and lactation,5.6. interaction with other medicaments and other forms of interaction,5.7. posology and method of administration for adults and, where necessary, for children,5.8. overdose (symptoms, emergency procedures, antidotes),5.9. special warnings,5.10. effects on ability to drive and to use machines.6. Pharmaceutical particulars:6.1. incompatibilities (major),6.2. shelf life, when necessary after reconstitution of the product or when the container is opened for the first time,6.3. special precautions for storage,6.4. nature and contents of container,6.5. name or style and permanent address or registered place of business of the holder of the marketing authorisation,6.6. special precautions for disposal of unused products or waste materials derived from such products, if appropriate.
As regards the grant of a marketing authorisation, the first paragraph of Article 5 of Directive 65/65 states: The authorisation provided for in Article 3 shall be refused if, after verification of the particulars and documents listed
in Article 4, it proves that the medicinal product is harmful in the normal conditions of use, or that its therapeutic efficacy
is lacking or is insufficiently substantiated by the applicant, or that its qualitative and quantitative composition is not
as declared.
As regards the suspension or withdrawal of a marketing authorisation, the first paragraph of Article 11 of Directive 65/65
provides: The competent authorities of the Member States shall suspend or revoke an authorisation to place a medicinal product on the
market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking,
or where its qualitative and quantitative composition is not as declared. ...
Second Directive 75/319/EEC
Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative
action relating to proprietary medicinal products (OJ 1975 L 147, p. 13), as amended by Directive 93/39, (
Directive 75/319) contains a Chapter III entitled
Committee for Proprietary Medicinal Products (
the CPMP) and consisting of Articles 8 to 15c, which has been completely rewritten by Directive 93/39.
Article 9 of Directive 75/319 establishes a procedure for the mutual recognition of national marketing authorisations.  It
states: 1. In order to obtain the recognition according to the procedures laid down in this chapter in one or more of the Member States
of an authorisation issued by a Member State in accordance with Article 3 of Directive 65/65/EEC, the holder of the authorisation
shall submit an application to the competent authorities of the Member State or Member States concerned, together with the
information and particulars referred to in Articles 4, 4a and 4b of Directive 65/65/EEC. ......4. Save in the exceptional case provided for in Article 10(1), each Member State shall recognise the marketing authorisation
granted by the first Member State within 90 days ....
Article 10(1) and (2) of Directive 75/319 provides: 1. Notwithstanding Article 9(4), where a Member State considers that there are grounds for supposing that the authorisation
of the medicinal product concerned may present a risk to public health ... , it shall forthwith inform the applicant, the
Member State which granted the initial authorisation, any other Member States concerned by the application and the [CPMP].
...2. All the Member States concerned shall use their best endeavours to reach agreement on the action to be taken in respect
of the application. ... However, if the Member States have not reached agreement within the time-limit referred to in Article
9(4) they shall forthwith refer the matter to the [CPMP] for the application of the procedure laid down in Article 13.
Article 11 of Directive 75/319 states that if several applications have been made for national marketing authorisations for
a particular medicinal product, and Member States have adopted divergent decisions, a Member State, the Commission or the
person responsible for placing the medicinal product on the market may refer the matter to the CPMP for application of the
procedure laid down in Article 13 of that directive.
The first paragraph of Article 12 of Directive 73/319 provides: The Member States or the Commission or the applicant or holder of the marketing authorisation may, in specific cases where
the interests of the Community are involved, refer the matter to the [CPMP] for the application of the procedure laid down
in Article 13 before reaching a decision on a request for a marketing authorisation or on the suspension or withdrawal of
an authorisation, or on any other variation to the terms of a marketing authorisation which appears necessary, in particular
to take account of the information collected [under the pharmacovigilance system provided for in] Chapter Va.
Article 15a of Directive 75/319 states: 1. Where a Member State considers that the variation of the terms of a marketing authorisation which has been granted in accordance
with the provisions of this chapter or its suspension or withdrawal is necessary for the protection of public health, the
Member State concerned shall forthwith refer the matter to the [CPMP] for the application of the [procedures] laid down in
Articles 13 and 14.2. Without prejudice to the provisions of Article 12, in exceptional cases, where urgent action is essential to protect public
health, until a definitive decision is adopted a Member State may suspend the marketing and the use of the medicinal product
concerned on its territory.  It shall inform the Commission and the other Member States no later than the following working
day of the reasons for its action.
As regards procedural issues, Article 13 of Directive 75/319, which governs the procedure before the CPMP, provides that at
the end of that procedure the CPMP is to issue a reasoned opinion.  Article 13(5) states that the European Agency for the
Evaluation of Medicinal Products (
the Agency) is to forward the final opinion of the CPMP to the Member States, the Commission and the person responsible for placing
the medicinal product on the market, together with a report describing the assessment of the medicinal product and stating
the reasons for its conclusions.
Article 14 of Directive 75/319 lays down the procedure to be followed after the Commission receives the opinion of the CPMP.
Pursuant to the first subparagraph of Article 14(1), within 30 days of the receipt of that opinion the Commission is to prepare
a draft of the decision to be taken in respect of the application.  The third subparagraph of Article 14(1) states that
[w]here, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also
annex a detailed explanation of the reasons for the differences.
Background to the dispute
Artegodan GmbH, Bruno Farmaceutici SpA, Essential Nutrition Ltd, Hoechst Marion Roussel Ltd, Hoechst Marion Roussel SA, Marion
Merrell SA (France), Marion Merrell SA (Spain), Sanova Pharma GmbH, Temmler Pharma GmbH & Co. KG, Schuck GmbH, Laboratórios
Roussel L
da
, Laboratoires Roussel Diamant SARL, Roussel Iberica SA, Gerot Pharmazeutika GmbH, Cambridge Healthcare Supplies Ltd and Laboratoires
pharmaceutiques Trenker SA are holders of marketing authorisations, initially issued by the competent national authorities,
for medicinal products containing
amphetamine-like anorectic agents, namely, as the case may be, phentermine, amfepramone, clobenzorex, fenproporex or norpseudoephedrine.
Commission Decision C(96) 3608 final/1
After a referral had been made to it by the Federal Republic of Germany under Article 12 of Directive 75/319, the CPMP initiated
the procedure provided for in Article 13 of that directive, in accordance with which, on 17 July 1996, it issued three final
opinions on various
amphetamine-like anorectics.
That procedure led to the adoption of Commission Decision C(96) 3608 final/1 of 9 December 1996 concerning the placing on
the market of the medicinal products for human use which contain the following substances: clobenzorex, norpseudoephedrine,
phentermine, fenproporex, mazindol, amfepramone, phendimetrazine, phenmetrazine, mefenorex (
the 1996 decision).
By that decision, which was expressly based on Article 14 of Directive 75/319, the Commission, in accordance with the CPMP
opinions of 17 July 1996, instructed the Member States concerned to amend certain clinical particulars in the summaries of
product characteristics approved when the marketing authorisations of the medicinal products in question were granted.  It
stipulated that a series of clinical particulars be included, relating to the therapeutic indications, posology, method of
administration, contraindications, special warnings and precautions for use, and undesirable effects of those medicinal products.
The decisions at issue
In response to information submitted by the Belgian and Austrian Governments, the CPMP initiated the procedure provided for
in Article 13 of Directive 75/319 in respect of phentermine, amfepramone and other
amphetamine-like anorectics,
inter alia
clobenzorex, fenproporex and norpseudoephedrine.  On 31 August 1999 it issued three final opinions.
On 9 March 2000, on the basis of Article 15a of Directive 75/319, the Commission adopted the decisions at issue concerning
the withdrawal of marketing authorisations of medicinal products for human use which contain phentermine (Decision C(2000)
452), amfepramone (Decision C(2000) 453) and the following substances: clobenzorex, fenbutrazate, fenproporex, mazindol, mefenorex,
norpseudoephedrine, phenmetrazine, phendimetrazine or propylhexedrine (Decision C(2000) 608).
In Article 1 of the operative part of each of the decisions at issue, the Commission ordered the Member States to
withdraw the national marketing authorisations provided for in the first paragraph of Article 3 of Directive 65/65 ... concerning
the medicinal products listed in Annex I [to the decision] which contain the [substance or substances assessed].  Article 2 of each of the decisions at issue justified that withdrawal by referring to the Agency's scientific conclusions
on the substance or substances concerned, included as Annex II to the respective decision.  Article 3 of each of the decisions
at issue required the Member States concerned to comply with the decision within 30 days of its notification.
The judgment under appeal
By the judgment under appeal, the Court of First Instance annulled the three decisions at issue in so far as they relate to
the medicinal products marketed by the applicants at first instance.
In the first place, the Court of First Instance upheld the plea put forward by the applicants at first instance alleging the
Commission's lack of competence to take the decisions at issue.
The Court of First Instance first of all found that it was common ground between the parties that the marketing authorisations
of the medicinal products referred to by the decisions at issue had been granted, and in some cases renewed, in accordance
with the national procedures applicable in the various Member States concerned, and not in accordance with the mutual recognition
procedure, coupled with arbitration procedures, provided for in Chapter III of Directive 75/319 (paragraph 113 of the judgment
under appeal).
The Court of First Instance accordingly inferred that,
[l]eaving aside the [1996] decision ..., those authorisations were thus purely national and that
the suspension, variation or withdrawal of those authorisations therefore came, at the time when the [decisions at issue]
were adopted, within the exclusive competence of the Member States concerned, a competence which, following the introduction
of the mutual recognition procedure by Directive 93/39, is essentially residual (paragraph 114 of the judgment under appeal).  According to the Court of First Instance's interpretation of the Community
legislation,
[s]ince 1 January 1995 that exclusive competence [of the Member States] has been restricted to, first, the grant and management
of marketing authorisations for medicinal products marketed solely in a single Member State and, second, the management of
purely national marketing authorisations granted before that date or during the transitional period from 1 January 1995 to
31 December 1997 (paragraph 116 of the judgment under appeal).
The Court of First Instance then examined whether, following their amendment pursuant to the 1996 decision, the marketing
authorisations of the medicinal products in question fell within the scope of Article 15a(1) of Directive 75/319, which is
the legal basis on which the Commission adopted the decisions at issue. Finding that that provision refers to marketing authorisations
granted in accordance with the provisions of Chapter III of that directive, the Court of First Instance interpreted it to
mean that
the variation, suspension or withdrawal of such authorisations, on the initiative of a Member State with a view to the protection
of public health, fall within the exclusive competence of the Commission, when adopting a decision following a CPMP opinion
in accordance with the procedures laid down in Articles 13 and 14 of Directive 75/319 while,
[c]onversely, the variation, suspension and withdrawal of marketing authorisations which do not fall within the ambit of Article
15a remain, in principle, subject to the exclusive competence of the Member States (paragraph 121 of the judgment under appeal).
The Court of First Instance held that since the wording of Articles 12 and 15a of Directive 75/319 provided no clear guidance
it was necessary to consider whether, in the scheme of Chapter III of that directive, and in the light of the directive's
aims, Article 15a(1), in conjunction with Article 12, could be construed as also applying to national marketing authorisations
which have been harmonised under Article 12 (paragraph 125 of the judgment under appeal).
To that end, the Court of First Instance considered the question of which authority is competent to adopt a decision following
a CPMP opinion under Article 12 of Directive 75/319, an article which does no more than expressly provide for the application
of the consultative procedure set out in Article 13 of that directive.  It held in that respect that Article 12 of Directive
75/319
is intended to apply in the residual field of exclusive competence of the Member States, or when the initial marketing authorisation
of a medicinal product is granted by the reference Member State (paragraph 142 of the judgment under appeal) and that it
cannot be interpreted as implicitly empowering the Commission to adopt a binding decision under the procedure set out in Article
14 of that directive (paragraph 147 of the judgment under appeal), unlike Article 10(2) which, although it also refers to the
consultative procedure set out in Article 13, is none the less part of a different framework, that of the mutual recognition
procedure (paragraphs 130 to 133 of the judgment under appeal).  The Court of First Instance reached these conclusions by
means of an interpretative approach based in particular on the scheme of Chapter III of Directive 75/319 and its objectives.
The Court of First Instance noted that the 1996 decision had been complied with by the Member States and found, finally, that
it was none the less necessary to consider whether, in the scheme of Chapter III of Directive 75/319, marketing authorisations
harmonised by the Member States following consultation of the CPMP under Article 12 of that directive could nevertheless be
placed on the same footing as marketing authorisations granted in accordance with the provisions of Chapter III (paragraph
148 of the judgment under appeal).
In that connection, the Court of First Instance found that
in the absence of an express provision, the principle, set out in the first paragraph of Article 5 EC, that the Community
is to act within the limits of the powers conferred upon it, precludes an interpretation of Article 15a(1) of Directive 75/319
to the effect that the harmonisation of certain marketing authorisations, in accordance with a non-binding opinion of the
CPMP under Article 12 of that directive, can have the effect of depriving the Member States concerned of their powers, by
triggering the application of the arbitration procedure provided for in Article 15a in respect of the adoption of any subsequent
decision regarding the suspension or withdrawal of such authorisations (paragraph 150 of the judgment under appeal).  It thus held that,
in the scheme of Directive 75/319, the concept of a marketing authorisation granted in accordance with the provisions of Chapter
III of that directive, referred to in Article 15a(1), cannot be interpreted as also including authorisations harmonised following
consultation of the CPMP under Article 12 (paragraph 155 of the judgment under appeal).
The Court of First Instance accordingly concluded that the decisions at issue had no legal basis and that the plea in law
alleging the Commission's lack of competence was well founded.
In the second place, the Court of First Instance held that, even assuming that the Commission had been competent to adopt
the decisions at issue, they would nevertheless be flawed on the ground of infringement of Article 11 of Directive 65/65 (paragraphs
156 and 170 to 221 of the judgment under appeal).
Procedure before the Court and the forms of order sought
By separate document lodged at the Court Registry on 3 February 2003, the Commission requested the Court to order that the
case be determined pursuant to an expedited procedure, in accordance with Article 62a of the Rules of Procedure.
By separate document lodged at the Court Registry on the same day, the Commission applied to the Court under Article 242 EC
for suspension of operation of the judgment under appeal.
On the basis of a recommendation by the Judge-Rapporteur and after hearing the respondents and the Advocate General, the President
of the Court decided, on 26 February 2003, that the case should be determined pursuant to an expedited procedure.
By order of 8 May 2003 in Case C-39/03 P-R
Commission
v
Artegodan and Others
[2003] ECR I-4485 the President of the Court dismissed the application for suspension of operation of the judgment under
appeal.
The Commission claims that the Court should set aside the judgment under appeal and order the respondents to pay the costs.
The respondents contend that the Court should dismiss the appeal and order the Commission to pay the costs.
The appeal
In support of its appeal, the Commission raises pleas in law relating, first, to the reasoning of the Court of First Instance
on the Commission's lack of competence to adopt the decisions at issue and, second, to the interpretation adopted by the Court
of First Instance of the conditions for withdrawal of the marketing authorisations, such as those conditions are defined by
the first paragraph of Article 11 of Directive 65/65.
As to its competence to adopt the decisions at issue, the Commission principally claims that the Court of First Instance misinterpreted
Articles 15a and 12 of Directive 75/319 in holding that those articles did not confer on the Commission the competence to
adopt the decisions at issue.  In the alternative, it claims that the Court of First Instance misinterpreted those articles
by failing to take into consideration the effects of the harmonisation of the marketing authorisations of the medicinal products
in question, which had been effected by the 1996 decision.
By the first part of its principal plea in law, the Commission submits that the Court of First Instance misinterpreted both
the wording and the purpose of Article 15a of Directive 75/319.  In its reference to a marketing authorisation
which has been granted in accordance with the provisions of [Chapter III of Directive 75/319], that provision refers to the whole of that chapter, and in particular to Articles 10, 11 and 12 thereof.  Like those three
articles, Article 15a of Directive 75/319 is intended to prevent Member States from taking divergent unilateral measures with
respect to the marketing authorisation for a given medicinal product, in order to ensure a high degree of protection of public
health in all Member States.  On the basis of an historical approach to the interpretation of Chapter III of Directive 75/319,
the Commission asserts that Article 15a must be regarded as a
follow-up procedure and must apply to all the procedures set out in Chapter III.
According to the Commission, the Court of First Instance also misinterpreted the division of powers between the Community
and the Member States, laid down in Directive 75/319.  In contrast to what the Court of First Instance held, in particular
in paragraphs 116 and 121 of the judgment under appeal, that directive does not delimit the respective
exclusive competences of the Member States and the Commission.  In actual fact, the provisions of Chapter III of Directive 75/319 form
part of an approach based on shared and complementary powers, whereby the Member States are responsible for national marketing
authorisations for medicinal products for human use and the Community is responsible for protecting public health and the
single market for medicinal products whenever this is required in the various situations referred to in Articles 10, 11, 12
and 15a of that directive.  In those situations, the Member States are responsible for launching an arbitration procedure
by referring the matter to the CPMP for the application of the procedures laid down in Articles 13 and 14 of the directive.
The Commission is then empowered to adopt a decision, the implementation of which is incumbent on the Member States.
The respondents dispute the Commission's analysis.  They essentially submit that the clear wording of Article 15a(1) of Directive
75/319 makes a detailed examination of that provision redundant.  Its sole purpose is to ensure that marketing authorisations
are not treated differently in different Member States once they have been issued under the mutual recognition procedure.
The 1996 decision did not result in harmonisation for the simple reason that that decision related only to the summaries
of product characteristics of the medicinal products in question.  It was a question of supplementing the national marketing
authorisations in respect of the active substances of those medicinal products.  An amendment of that kind cannot be placed
on the same footing as a decision under a mutual recognition procedure and consequently the competence to amend, suspend or
withdraw the marketing authorisations of the medicinal products in question remains with the Member States.  No other construction
of Article 15a of Directive 75/319 can be based on an historical interpretation of Chapter III of that directive or, moreover,
reconciled with the subsidiarity principle enshrined in Article 5 EC.
In that regard, it should be noted that the decisions at issue were adopted solely on the basis of Article 15a of Directive
75/319.
According to its wording, Article 15a of Directive 75/319 applies to marketing authorisations which have been granted in accordance
with the provisions of Chapter III of that directive.
The Court of First Instance found, and this was not contested by the Commission, that the marketing authorisations whose withdrawal
was ordered by the decisions at issue were initially granted under purely national procedures.
Assuming that the purpose of Article 15a of Directive 75/319 is to be interpreted broadly and the provision can thus be held
to apply to marketing authorisations which have not been granted under Chapter III but which have been the subject of another
harmonisation procedure, it becomes necessary in the present case to determine whether the 1996 decision can be regarded as
having brought about such harmonisation.
It is common ground that the 1996 decision merely ordered the amendment of certain terms of the initial marketing authorisations,
namely the clinical particulars which, along with other data, must be included in the summary of product characteristics in
accordance with point 5 of Article 4a of Directive 65/65.
A partial amendment of that kind cannot amount to an authorisation granted in accordance with the provisions of Chapter III
of Directive 75/319.
It is therefore of no importance whether that partial amendment of the marketing authorisations of the medicinal products
in question was the result of compliance with a binding decision or of voluntary harmonisation by the Member States.
It follows that Article 15a of Directive 75/319 could not be used as a legal basis for the decisions at issue.
In those circumstances, and without it being necessary to rule on the other pleas and arguments put forward by the Commission,
the Court finds that the Court of First Instance was right to hold that the Commission lacked the competence to adopt the
decisions at issue and that, accordingly, those decisions had to be annulled.
It follows from all the foregoing considerations that the appeal must be dismissed.
Costs
Under Article 69(2) of the Rules of Procedure, applicable to the procedure on appeal by virtue of Article 118 of the Rules,
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 respondents have applied for costs and the Commission has been unsuccessful, the latter must be ordered to pay the
costs of these proceedings and of those relating to the application for interim relief.
On those grounds,
THE COURT (Full Court),
hereby:
1.
Dismisses the appeal;
2.
Orders the Commission of the European Communities to pay the costs of these proceedings and those relating to the application
for interim relief.
Rodríguez Iglesias
Puissochet
Wathelet
Schintgen
Timmermans
Gulman
Edward
La Pergola
Jann
Skouris
Macken
Colneric
von Bahr
Cunha Rodrigues
Rosas
Delivered in open court in Luxembourg on 24 July 2003.
R. Grass
G.C. Rodríguez Iglesias
Registrar
President
–
Languages of the case: German,Englishand French.