**Joined Cases C-468/06 to C-478/06**

**Sot. Lélos kai Sia EE and Others**

**v**

**GlaxoSmithKline AEVE Farmakeftikon Proionton, formerly Glaxowellcome AEVE**

(References for a preliminary ruling from the Efetio Athinon)

(Article 82 EC – Abuse of dominant position – Pharmaceutical products – Refusal to supply wholesalers engaging in parallel exports – Ordinary orders)

Summary of the Judgment

1.        *Competition – Dominant position – Abuse – Refusal to supply wholesalers which export to other Member States – Conditions –
Refusal liable to eliminate all effective competition*

*(Art. 82 EC)*

2.        *Competition – Dominant position – Abuse – Refusal to supply – Conditions*

*(Arts 3(1)(g) EC and 82 EC)*

3.        *Competition – Dominant position – Abuse – Refusal to supply wholesalers which export to other Member States – Pharmaceuticals
sector – Impact of the effects of parallel trade of medicinal products for the final consumer on the abusive nature of the
refusal*

*(Art. 82 EC)*

4.        *Competition – Community rules – Scope ratione materiae – Practices aimed at preventing or restricting parallel exports – Included*

*(Arts 3(1)(g) EC, 81 EC and 82 EC)*

5.        *Competition – Community rules – Scope ratione materiae – Pharmaceutical sector subject to national price regulation – Included*

*(Arts 81 EC and 82 EC)*

6.        *Competition – Dominant position – Abuse – Refusal to supply wholesalers which export to other Member States – Pharmaceutical
sector – Effect of national regulation concerning prices of medicinal products on the abusive nature of the refusal*

*(Arts 3(1)(g) and (t) EC and 82 EC)*

1.        The refusal by an undertaking occupying a dominant position on the market of a given product to meet the orders of an existing
customer constitutes abuse of that dominant position under Article 82 EC where, without any objective justification, that
conduct is liable to eliminate a trading party as a competitor. With regard to a refusal by an undertaking to deliver its
products in one Member State to wholesalers which export those products to other Member States, such an effect on competition
may exist not only if the refusal impedes the activities of those wholesalers in that first Member State, but equally if it
leads to the elimination of effective competition from them in the distribution of the products on the markets of the other
Member States.

(see paras 34-35)

2.        An undertaking in a dominant position for the purpose of marketing a product – which cashes in on the reputation of a brand
name known to and valued by consumers – cannot stop supplying a long-standing customer who abides by regular commercial practice,
if the orders placed by that customer are in no way out of the ordinary. Such conduct is inconsistent with the objectives
laid down in Article 3(1)(g) EC, which are set out in detail in Article 82 EC, particularly in points (b) and (c) of the second
paragraph of that article, since the refusal to sell would limit the markets to the prejudice of consumers and would amount
to discrimination which might in the end eliminate a trading party from the relevant market.

(see para. 49)

3.        In order to determine whether the refusal by a pharmaceuticals company occupying a dominant position on the national distribution
market for certain medicinal products to meet the orders of wholesalers involved in parallel exports to other Member States
where the selling prices of those medicines are set at a higher level indeed falls within the prohibition laid down in Article
82 EC, in particular at point (b) of the second paragraph of that article, it must be examined whether there are objective
considerations based on which such a practice cannot be regarded as an abuse of the dominant position occupied by that undertaking.

In that connection, such an undertaking cannot rely on the fact that the parallel exports which it seeks to limit are of only
minimal benefit to the final consumers. Parallel exports of medicinal products from a Member State where the prices are low
to other Member States in which the prices are higher open up in principle an alternative source of supply to buyers of the
medicinal products in those latter States, which necessarily brings some benefits to the final consumer of those products.
The attraction of the other source of supply which arises from parallel trade in the importing Member State lies in the fact
that that trade is capable of offering the same products on the market of that Member State at lower prices than those applied
on the same market by the pharmaceuticals companies. As a result, even in the Member States where the prices of medicines
are subject to State regulation, parallel trade is liable to exert pressure on prices and, consequently, to create financial
benefits not only for the social health insurance funds, but equally for the patients concerned, for whom the proportion of
the price of medicines for which they are responsible will be lower. At the same time, parallel trade in medicines from one
Member State to another is likely to increase the choice available to entities in the latter Member State which obtain supplies
of medicines by means of a public procurement procedure, in which the parallel importers can offer medicines at lower prices.

(see paras 38-39, 51, 53, 55-57)

4.        In relation to the application of Article 81 EC, an agreement between producer and distributor which might tend to restore
the national divisions in trade between Member States might be such as to frustrate the objective of the Treaty to achieve
the integration of national markets through the establishment of a single market. Thus, agreements aimed at partitioning national
markets according to national borders or making the interpenetration of national markets more difficult, in particular those
aimed at preventing or restricting parallel exports, have been held by the Community judicature to be agreements whose object
is to restrict competition within the meaning of that article of the Treaty. In the light of the abovementioned Treaty objective
as well as that of ensuring that competition in the internal market is not distorted, there can be no escape from the prohibition
laid down in Article 82 EC for the practices of an undertaking in a dominant position which are aimed at avoiding all parallel
exports from a Member State to other Member States, practices which, by partitioning the national markets, neutralise the
benefits of effective competition in terms of the supply and the prices that those exports would obtain for final consumers
in the other Member States.

(see paras 65-66)

5.        The fact that there is a degree of State price regulation in the pharmaceuticals sector cannot preclude the Community rules
on competition from applying. First, the control exercised by Member States over the selling prices or the reimbursement of
those products does not entirely remove their prices from the law of supply and demand. Secondly, where a pharmaceutical product
is protected by a patent which confers a temporary monopoly on its holder, the price competition which may exist between a
producer and its distributors, or between parallel traders and national distributors, is, until the expiry of that patent,
the only form of competition which can be envisaged.

(see paras 61, 64, 67)

6.        The intensity of the regulation regarding the price of medicines cannot prevent any refusal by a pharmaceuticals company in
a dominant position to meet orders sent to it by wholesalers involved in parallel exports from constituting an abuse. Nevertheless
such a company must be in a position to take steps that are reasonable and in proportion to the need to protect its own commercial
interests.

It cannot be ignored that, in Member States with a system of price regulation in the pharmaceuticals sector, such State intervention
is one of the factors liable to create opportunities for parallel trade. Furthermore, in the light of the Treaty objectives
to protect consumers by means of undistorted competition and the integration of national markets, the rules on competition
are incapable of being interpreted in such a way that, in order to defend its own commercial interests, the only choice left
for a pharmaceuticals company in a dominant position is not to place its medicines on the market at all in a Member State
where the prices of those products are set at a relatively low level.

In order to appraise whether the refusal by such a pharmaceuticals company to supply wholesalers involved in parallel exports
constitutes a reasonable and proportionate measure in relation to the threat that those exports represent to its legitimate
commercial interests, it must therefore be ascertained whether the orders of the wholesalers are out of the ordinary in the
light of both the previous business relations between the company and the wholesalers concerned and the size of the orders
in relation to the requirements of the market in the Member State concerned.

Although such a company, in a Member State where prices are relatively low, cannot be allowed to cease to honour the ordinary
orders of an existing customer for the sole reason that that customer, in addition to supplying the market in that Member
State, exports part of the quantities ordered to other Member States with higher prices, it is none the less permissible for
that company to counter in a reasonable and proportionate way the threat to its own commercial interests potentially posed
by the activities of an undertaking which wishes to be supplied in the first Member State with significant quantities of products
that are essentially destined for parallel export.

Article 82 EC must therefore be interpreted as meaning that an undertaking occupying a dominant position on the relevant market
for medicinal products which, in order to put a stop to parallel exports carried out by certain wholesalers from one Member
State to other Member States, refuses to meet ordinary orders from those wholesalers, is abusing its dominant position. It
is for the national court to ascertain whether the orders are ordinary in the light of both the size of those orders in relation
to the requirements of the market in the first Member State and the previous business relations between that undertaking and
the wholesalers concerned.

(see paras 67-71, 73, 77, operative part)


JUDGMENT OF THE COURT (Grand Chamber)

16 September 2008 ([\*](#Footnote*))

(Article 82 EC – Abuse of dominant position – Pharmaceutical products – Refusal to supply wholesalers engaging in parallel exports – Ordinary orders)

In Joined Cases C‐468/06 to C‐478/06,

REFERENCES for a preliminary ruling under Article 234 EC from the Efetio Athinon (Greece), made by decisions of 3 March 2006
(C‐468/06 to C‐474/06), 17 March 2006 (C‐475/06 and C‐476/06) and 7 April 2006 (C‐477/06 and C‐478/06), received at the Court
on 21 November 2006, in the proceedings

**Sot. Lelos kai Sia EE** (C‐468/06)**,**

**Farmakemporiki AE Emporias kai Dianomis Farmakeftikon Proionton** (C‐469/06)**,**

**Konstantinos Xidias kai Sia OE** (C-470/06)**,**

**Farmakemporiki AE Emporias kai Dianomis Farmakeftikon Proionton** (C‐471/06)**,**

**Ionas Stroumsas EPE** (C‐472/06)**,**

**Ionas Stroumsas EPE** (C‐473/06)**,**

**Farmakapothiki Farma-Group Messinias AE** (C‐474/06)**,**

**K.P. Marinopoulos AE Emporias kai Dianomis Farmakeftikon Proionton** (C‐475/06)**,**

**K.P. Marinopoulos AE Emporias kai Dianomis Farmakeftikon Proionton** (C‐476/06)**,**

**Kokkoris D. Tsanas K. EPE and Others** (C-477/06)**,**

**Kokkoris D. Tsanas K. EPE and Others** (C-478/06)**,**

v

**GlaxoSmithKline AEVE Farmakeftikon Proionton, formerly Glaxowellcome AEVE,**

THE COURT (Grand Chamber),

composed of V. Skouris, President, P. Jann, C.W.A. Timmermans, A. Rosas, K. Lenaerts (Rapporteur) and A. Tizzano, Presidents
of Chambers, R. Silva de Lapuerta, K. Schiemann, J. Makarczyk, P. Lindh, J.-C. Bonichot, T. von Danwitz and A. Arabadjiev,
Judges,

Advocate General: D. Ruiz-Jarabo Colomer,

Registrar: L. Hewlett, Principal Administrator,

having regard to the written procedure and further to the hearing on 29 January 2008,

after considering the observations submitted on behalf of:

–        Sot. Lelos kai Sia EE (C-468/06), by S.E. Kiliakovou, dikigoros,

–        Farmakemporiki AE Emporias kai Dianomis Farmakeftikon Proionton (C‐469/06 and C-471/06), Konstantinos Xidias kai Sia OE (C-470/06),
Ionas Stroumsas EPE (C-472/06 and C-473/06), Farmakapothiki Farma-Group Messinias AE (C-474/06) and K.P. Marinopoulos AE Emporias
kai Dianomis Farmakeftikon Proionton (C-475/06 and C-476/06), by L. Roumanias and G. Papaïoannou, dikigoroi,

–        Kokkoris D. Tsanas K. EPE and Others (C-477/06 and C-478/06), by G. Mastorakos, dikigoros,

–        GlaxoSmithKline AEVE Farmakeftikon Proionton, by A. Komninos, D. Kyriakis, T. Kloukinas and S. Zervoudaki, dikigoroi, and
by I. Forrester QC and A. Schulz, Rechtsanwalt,

–        the Italian Government, by I.M. Braguglia, acting as Agent, assisted by F. Arena, avvocato dello Stato,

–        the Polish Government, by E. Ośniecka-Tamecka, P. Kucharski and T. Krawczyk, acting as Agents,

–        the Commission of the European Communities, by T. Christoforou, F. Castillo de la Torre and E. Gippini Fournier, acting as
Agents,

after hearing the Opinion of the Advocate General at the sitting on 1 April 2008,

gives the following

**Judgment**

1        These references for a preliminary ruling concern the interpretation of Article 82 EC.

2        The references were made in proceedings brought by Sot. Lelos kai Sia EE, Farmakemporiki AE Emporias kai Dianomis Farmakeftikon
Proionton, Konstantinos Xidias kai Sia OE, Ionas Stroumsas EPE, Farmakapothiki Farma-Group Messinias AE, K.P. Marinopoulos
AE Emporias kai Dianomis Farmakeftikon Proionton, and Kokkoris D. Tsanas K. EPE and Others, pharmaceuticals wholesalers, (‘the
appellants in the main proceedings’) against GlaxoSmithKline AEVE Farmakeftikon Proionton, formerly Glaxowellcome AEVE, (‘GSK
AEVE’) in respect of the latter’s refusal to meet those wholesalers’ orders for certain medicinal products.

**The legal framework**

*Community legislation*

3        Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal
products for human use and their inclusion in the scope of national health insurance systems (OJ 1989 L 40, p. 8) lays down
certain requirements for Member States when applying national measures to control the prices of medicinal products for human
use or to restrict the range of medicinal products covered by their national health insurance systems.

4        The second to fourth recitals to that directive read as follows:

‘Whereas Member States have adopted measures of an economic nature on the marketing of medicinal products in order to control
public health expenditure on such products; whereas such measures include direct and indirect controls on the prices of medicinal
products as a consequence of the inadequacy or absence of competition in the medicinal products market and limitations on
the range of products covered by national health insurance systems;

Whereas the primary objective of such measures is the promotion of public health by ensuring the availability of adequate
supplies of medicinal products at a reasonable cost; whereas, however, such measures should also be intended to promote efficiency
in the production of medicinal products and to encourage research and development into new medicinal products, on which the
maintenance of a high level of public health within the Community ultimately depends;

Whereas disparities in such measures may hinder or distort intra-Community trade in medicinal products and thereby directly
affect the functioning of the common market in medicinal products[.]’

5        Article 81 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:

‘With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products
to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another
Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom
they have themselves authorised to engage in equivalent activities.

The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually
placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued
supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of
patients in the Member State in question are covered.

The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be
proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning
the free movement of goods and competition.’

*National legislation*

6        Article 2 of Greek Law 703/1977 on the control of monopolies and oligopolies and the protection of free competition (FEK A’
278) essentially corresponds to the provisions of Article 82 EC.

7         Under Article 29 of Greek Law 1316/1983, holders of an authorisation to market pharmaceutical products are required to supply
the market regularly with the goods which they manufacture or import.

8        Furthermore, Greek legislation requires persons carrying out the business of pharmaceuticals wholesaler to obtain a specific
licence and to supply the needs of a defined geographical area with a range of pharmaceutical products.

**The main proceedings and the reference for a preliminary ruling**

9        GSK AEVE is the Greek subsidiary of GlaxoSmithKline plc, a pharmaceuticals research and manufacturing company established
in the United Kingdom (‘GSK plc’). GSK AEVE imports, warehouses and distributes pharmaceutical products of the GSK group (‘GSK’)
in Greece. As such, it holds the marketing authorisation in Greece inter alia for the medicinal products Imigran, Lamictal
and Serevent for the treatment, respectively, of migraines, epilepsy and asthma (‘the medicinal products in dispute’), which
are available in Greece only on prescription.

10      Each of the appellants in the main proceedings had for a number of years bought those medicinal products in all their forms
from GSK AEVE, in order to distribute them both on the Greek market and in other Member States.

11      Towards the end of October 2000, GSK AEVE altered its system of distribution on the Greek market, citing a shortage, for which
it denied responsibility, of those medicines. From 6 November 2000 it stopped meeting the orders of the appellants in the
main proceedings for the medicinal products in dispute and began itself to distribute those products to Greek hospitals and
pharmacies through the company Farmacenter AE (‘Farmacenter’).

12      In December 2000 GSK AEVE applied to the Epitropi Antagonismou (Competition Commission) for negative clearance in the form
of a declaration that its new policy of selling the medicines directly to Greek hospitals and pharmacies did not infringe
Article 2 of Law 703/1977.

13      In February 2001, taking the view that the supply of medicines on the Greek market had to some extent normalised and that
stocks at hospitals and pharmacies had been reconstituted, GSK AEVE started once more to supply the appellants in the main
proceedings and other wholesalers with limited quantities of the medicinal products in dispute and shortly afterwards brought
its cooperation with Farmacenter to an end.

14      GSK AEVE then withdrew its application for negative clearance but in the course of February 2001 filed a new application for
negative clearance in respect of its sales policy, which in turn was replaced in December 2001 by another such application.
Following discussions with the Epitropi Antagonismou, GSK AEVE agreed to deliver quantities of medicines equivalent to national
consumption plus 18%.

15      Meanwhile, the appellants in the main proceedings and other pharmaceuticals wholesalers, as well as some Greek associations
of pharmacists and wholesalers, applied to the Epitropi Antagonismou for a declaration that the sales policy of GSK AEVE and
GSK plc in respect of the medicinal products in dispute constituted an abuse of a dominant position under Article 2 of Law
703/1977 and Article 82 EC.

16      On 3 August 2001, a decision of the Epitropi Antagonismou ordering interim measures required GSK AEVE to meet the orders of
the appellants in the main proceedings for the medicinal products in dispute pending adoption of a final decision in the case.
GSK AEVE lodged applications with the Diikitiko Efetio Athinon (Administrative Appeal Court, Athens) for a stay of execution
and an annulment of that decision, which that court rejected.

17      Having been informed by GSK AEVE of the difficulties it faced in supplying the wholesalers with the quantities requested,
the Ethnikos Organismos Farmakon (National Organisation for Medicines) published a circular on 27 November 2001 which obliged
pharmaceuticals companies and all distributors of medicines to deliver quantities equivalent to those required for prescription
medicines plus 25%.

18      Between 30 April 2001 and 11 November 2002, each of the appellants in the main proceedings brought an action before the Polimeles
Protodikio Athinon (Court of First Instance, Athens), claiming that the conduct of GSK AEVE in interrupting supplies of medicinal
products which had been ordered and distributing them through Farmacenter constituted unfair and anticompetitive acts and
an abuse of the dominant position occupied by GSK AEVE on the markets for the medicinal products in dispute. In their applications,
those appellants asked for GSK AEVE to be ordered, first, to supply them with quantities of medicines corresponding to the
monthly average of those it had delivered to them in the period from 1January to 31 October 2000 and, second, to pay them damages and compensate them for loss of profits. Some of the applications
contained a more specific request for GSK AEVE to be ordered to continue supplies by providing quantities corresponding to
the monthly average of medicines that it had delivered to them during the same period plus a certain percentage.

19      In view of both the complaints mentioned in paragraph 15 of this judgment and the request for negative clearance that were
pending before it, the Epitropi Antagonismou by decision of 22 January 2003 asked the Court a series of questions relating
to the interpretation of Article 82 EC in a reference for a preliminary ruling, which was registered at the Court Registry
under the number C‐53/03.

20      Between January and October 2003, the Polimeles Protodikio Athinon gave judgment on the actions commenced by the appellants
in the main proceedings against GSK AEVE. Although it ruled that the actions were admissible, with the exception of the claims
for compensation for loss of profits, that court dismissed them as unfounded, on the ground that the refusal on the part of
GSK AEVE to supply was not unjustified and could thus not constitute abuse of that company’s dominant position.

21      The appellants in the main proceedings appealed against those judgments before the Efetio Athinon (Court of Appeal, Athens).
GSK AEVE cross-appealed in some of the cases. That court however suspended its examination of some of the cases before it
pending the Court’s decision in respect of the reference for a preliminary ruling made by the Epitropi Antagonismou.

22      By its judgment of 31 May 2005 in Case C‐53/03 *Syfait and Others* [2005] ECR I‐4609, the Court ruled that it had no jurisdiction to answer the questions referred by the Epitropi Antagonismou,
since the latter was not a court or tribunal within the meaning of Article 234 EC.

23      Considering that, in order to deliver its judgments, it is necessary to have answers to the same questions which the Epitropi
Antagonismou had referred to the Court, the Efetio Athinon has decided to stay the appeal proceedings and to refer the following
questions to the Court for a preliminary ruling:

‘1.       Where the refusal of an undertaking holding a dominant position to meet fully the orders sent to it by pharmaceuticals wholesalers
is due to its intention to limit their export activity and, thereby, the harm caused to it by parallel trade, does the refusal
constitute per se an abuse within the meaning of Article 82 EC? Is the answer to that question affected by the fact that the
parallel trade is particularly profitable for the wholesalers because of the different prices, resulting from State intervention,
in the Member States of the European Union, that is to say by the fact that pure conditions of competition do not prevail
in the pharmaceuticals market, but a regime which is governed to a large extent by State intervention? Is it ultimately the
duty of a national competition authority to apply Community competition rules in the same way to markets which function competitively
and those in which competition is distorted by State intervention?

2.       If the Court holds that limitation of parallel trade, for the reasons set out above, does not constitute an abusive practice
in every case where it is engaged in by an undertaking holding a dominant position, how is possible abuse to be assessed?

In particular:

(a)       Do the percentage by which normal domestic consumption is exceeded and/or the loss suffered by an undertaking holding a dominant
position compared with its total turnover and total profits constitute appropriate criteria? If so, how are the level of that
percentage and the level of that loss determined (the latter as a percentage of turnover and total profits), above which the
conduct in question may be abusive?

(b)       Is an approach entailing the balancing of interests appropriate, and, if so, what are the interests to be compared?

In particular:

(i)       is the answer affected by the fact that the ultimate consumer/patient derives limited financial advantage from the parallel
trade and

(ii)  is account to be taken, and to what extent, of the interests of social insurance bodies in cheaper medicinal products?

(c)       What other criteria and approaches are considered appropriate in the present case?’

24       By Decision 318/V/2006 of 1 September 2006, the Epitropi Antagonismou ruled on the complaints lodged with it against GSK.
In the decision it found that GSK did not occupy a dominant position on the markets for Imigran and Serevent in view of their
interchangeability with other medicinal products, but that a dominant position existed with respect to Lamictal, on account
of the fact that epilepsy sufferers may find it difficult to adjust to other medicines which treat that condition.

25      In the same decision, the Epitropi Antagonismou found that GSK had infringed Article 2 of Law 703/1977 during the period from
November 2000 to February 2001, but that there had been no infringement of that article in the period after February 2001
and no infringement of Article 82 EC during either of those periods.

26      The appellants in the main proceedings have applied to the Diikitiko Efetio Athinon for an annulment of that decision.

27      By order of the President of the Court of 29 January 2007, Cases C‐468/06 to C‐478/06 were joined for the purposes of the
written and oral procedures and the judgment.

**The questions referred for a preliminary ruling**

28      By its questions, which it is appropriate to examine together, the referring court essentially asks whether there is an abuse
of a dominant position contrary to Article 82 EC if a pharmaceuticals company occupying such a position on the national market
for certain medicinal products refuses to meet orders sent to it by wholesalers on account of the fact that those wholesalers
are involved in parallel exports of those products to other Member States.

29      In that context, the referring court asks the Court about the relevance of a series of factors, such as the degree of regulation
to which the pharmaceuticals sector is subject in Member States, the impact of parallel trade on the pharmaceuticals companies’
revenues, and the question whether that parallel trade is capable of generating financial benefits for the ultimate consumers
of the medicinal products.

30      In its observations lodged before the Court, GSK AEVE contends that its refusal to supply the requested quantities of medicinal
products to the appellants in the main proceedings does not constitute an abuse. First, it was not a case of an actual refusal
inasmuch as, apart from a period of a few weeks between November 2000 and February 2001, GSK AEVE was always prepared to supply
the wholesalers with sufficient quantities. Second, it did not put the wholesalers at risk of being eliminated from the market,
since its supplies enabled them to cover all the requirements of the Greek market, and even requirements that went beyond
those of that market.

31      According to GSK AEVE, the decisive factors for the question whether the conduct of a company that refuses to supply certain
goods is abusive depend on the economic and regulatory context of the situation in question. Thus, in the case of a supply
restriction in medicinal products in order to limit parallel trade, it is necessary to take into account the omnipresent regulation
of prices and distribution in the pharmaceuticals sector, the negative consequences of an unlimited parallel trade upon the
investments of pharmaceuticals companies in the field of research and development, and the minimal benefit of that trade for
the final consumers of those products.

32      By contrast, the appellants in the main proceedings, as well as the Italian and Polish Governments and the Commission of the
European Communities, maintain in their observations that the refusal by an undertaking in a dominant position to supply medicinal
products to wholesalers with the aim of restricting parallel trade constitutes in principle an abuse of a dominant position
within the meaning of Article 82 EC. According to them, none of the factors raised by the referring court and which were taken
up by GSK AEVE to justify its refusal to supply is capable of altering the abusive nature of that practice.

*The existence of a refusal to supply liable to eliminate competition*

33      Article 82 EC prohibits any abuse by one or more undertakings of a dominant position within the common market or in a substantial
part of it as incompatible with the common market in so far as it may affect trade between Member States. According to point
(b) of the second paragraph of that article, such abuse may, in particular, consist in limiting production, markets or technical
development to the prejudice of consumers.

34      The established case-law of the Court shows that the refusal by an undertaking occupying a dominant position on the market
of a given product to meet the orders of an existing customer constitutes abuse of that dominant position under Article 82
EC where, without any objective justification, that conduct is liable to eliminate a trading party as a competitor (see, to
that effect, Joined Cases 6/73 and 7/73 *Istituto Chemioterapico Italiano and Commercial Solvents* v *Commission* [1974] ECR 223, paragraph 25, and Case 27/76 *United Brands and United Brands Continentaal* v *Commission* [1978] ECR 207, paragraph 183).

35      With regard to a refusal by an undertaking to deliver its products in one Member State to wholesalers which export those products
to other Member States, such an effect on competition may exist not only if the refusal impedes the activities of those wholesalers
in that first Member State, but equally if it leads to the elimination of effective competition from them in the distribution
of the products on the markets of the other Member States.

36      In this case it is common ground between the parties in the main proceedings that, by refusing to meet the Greek wholesalers’
orders, GSK AEVE aims to limit parallel exports by those wholesalers to the markets of other Member States in which the selling
prices of the medicinal products in dispute are higher.

37      In respect of sectors other than that of pharmaceutical products, the Court has held that a practice by which an undertaking
in a dominant position aims to restrict parallel trade in the products that it puts on the market constitutes abuse of that
dominant position, particularly when such a practice has the effect of curbing parallel imports by neutralising the more favourable
level of prices which may apply in other sales areas in the Community (see, to that effect, Case 26/75 *General Motors Continental* v *Commission* [1975] ECR 1367, paragraph 12) or when it aims to create barriers to re-importations which come into competition with the
distribution network of that undertaking (Case 226/84 *British Leyland* v *Commission* [1986] ECR 3263, paragraph 24). Indeed, parallel imports enjoy a certain amount of protection in Community law because they
encourage trade and help reinforce competition (Case C‐373/90 *X* [1992] ECR I‐131, paragraph 12).

38      In its written observations, GSK AEVE contends that the factors mentioned by the referring court in its questions constitute
objective considerations, on the basis of which it cannot be regarded as an abuse for a pharmaceuticals company to limit supplies
of medicines to the needs of a given national market when confronted with orders from wholesalers involved in parallel exports
to other Member States where the selling prices of those medicines are set at a higher level.

39      In order to determine whether the refusal by a pharmaceuticals company to supply medicinal products to such wholesalers indeed
falls within the prohibition laid down in Article 82 EC, in particular at point (b) of the second paragraph of that article,
it must be examined whether, as GSK AEVE maintains, there are objective considerations based on which such a practice cannot
be regarded as an abuse of the dominant position occupied by that undertaking (see, to that effect, *United Brands and United Brands Continentaal* v *Commission*, paragraph 184, and Case C‐95/04 P *British Airways* v *Commission* [2007] ECR I‐2331, paragraph 69).

*The abusive nature of the refusal to supply*

40      As a preliminary point, GSK AEVE observes, citing *United Brands Continentaal* v *Commission*, that a dominant undertaking is not under an obligation to honour orders that are out of the ordinary and that it may take
reasonable steps in order to protect its legitimate commercial interests.

41      With regard more specifically to the pharmaceuticals sector, GSK AEVE argues, first, that the general logic behind protecting
competition within a brand does not function in that sector, where the intervention of the public authorities of Member States
prevents the manufacturers of medicines from developing their activities in normal competitive conditions.

42      On the one hand, the pharmaceuticals companies do not control the prices of their products, those prices being fixed at various
levels by the public authorities, which are, at the same time, the buyers of the medicines wherever there are national health
systems. Even where those prices are the result of negotiations between the authorities and the pharmaceuticals companies,
the fact that those companies accept them does not in itself imply that the prices cover all the fixed costs connected with
the development of the pharmaceutical products. Moreover, even if such a system of agreed prices exists, Member States are
still in a position to impose cuts in those prices.

43      On the other hand, the producers of medicines are subject to precise obligations with regard to their distribution. While
pharmaceuticals companies are required by law to deliver their products in all Member States where they are authorised to
do so, parallel exporters are free to shift their activities from one product or market to the next if the latter product
or market offers a higher profit margin, which can lead to shortages in some exporting Member States. Thus parallel trade
has negative consequences for the planning of production and distribution of medicines.

44      Second, GSK AEVE points out that parallel trade in medicines reduces the profits that pharmaceuticals companies can invest
in research and development activities on which they depend in order to remain competitive and attractive to investors. By
contrast, distributors which profit from parallel trade make no contribution to pharmaceutical innovation. Furthermore, in
the Member States where the prices of medicines are fixed at relatively low levels, the marketing of new medicines might be
affected if it became impossible for pharmaceuticals companies to hold back supplies with the aim of limiting parallel trade.
In such circumstances, those companies would have an interest in delaying the launch of new products in Member States where
the prices are low.

45      Third, GSK AEVE contends that parallel trade provides no genuine benefit to the ultimate consumers. Since the greater part
of the price difference which makes the business profitable is taken up by intermediaries, parallel trade does not result
in genuine pressure on the prices of medicines in the Member States where those prices are higher. Equally, in the case of
Member States where certain medicinal requirements are covered by public tender, parallel importers are not in a position
to reduce price levels in view of their sporadic presence on the market.

46      While recognising that the prohibition in Article 82 EC does not apply when the conduct of an undertaking in a dominant position
is objectively justified, the Polish Government and the Commission point out that it is for that undertaking to establish
that there are circumstances that are capable of justifying its practice.

47      The appellants in the main proceedings, as well as the Polish Government and the Commission, consider that Article 82 EC cannot
be applied differently in the pharmaceuticals sector simply because the prices in that sector are directly or indirectly fixed
by the public authorities. Even in the Member States where prices are low, the price of a medicinal product is the result
of negotiations with the pharmaceuticals companies, which will not put their products on the market if the prices proposed
are not acceptable to them. Furthermore, there is no causal link between the repercussions of parallel trade on the revenues
of pharmaceuticals companies and those companies’ investments in research and development. Finally, parallel trade in medicinal
products brings clear advantages to patients and is likely to enable national social security systems to make savings.

48      The appellants in the main proceedings add that taking into account the justifications advanced by GSK AEVE would run counter
to the Court’s case-law relating to the free movement of goods, which accepts only the justifications listed in Article 30
EC.

49      It should be recalled that in paragraph 182 of its judgment in *United Brands and United Brands Continentaal* v *Commission* the Court held that an undertaking in a dominant position for the purpose of marketing a product – which cashes in on the
reputation of a brand name known to and valued by consumers – cannot stop supplying a long-standing customer who abides by
regular commercial practice, if the orders placed by that customer are in no way out of the ordinary. In paragraph 183 of
the same judgment, the Court held that such conduct is inconsistent with the objectives laid down in Article 3(f) of the EEC
Treaty (Article 3(g) of the EC Treaty, and now Article 3(1)(g) EC), which are set out in detail in Article 86 of the EEC Treaty
(Article 86 of the EC Treaty, and now Article 82 EC), particularly in points (b) and (c) of the second paragraph of that article,
since the refusal to sell would limit the markets to the prejudice of consumers and would amount to discrimination which might
in the end eliminate a trading party from the relevant market.

50      In paragraph 189 of the judgment in *United Brands and United Brands Continentaal* v *Commission*, the Court stated that, although the fact that an undertaking is in a dominant position cannot deprive it of its right to
protect its own commercial interests if they are attacked, and that such an undertaking must be conceded the right to take
such reasonable steps as it deems appropriate to protect those interests, such behaviour cannot be accepted if its purpose
is specifically to strengthen that dominant position and abuse it.

51      It must be examined in this context whether, as GSK AEVE claims, particular circumstances are present in the pharmaceuticals
sector, by reason of which the refusal by an undertaking in a dominant position to supply clients in a given Member State
who engage in parallel exports to other Member States where prices for medicines are higher does not, generally speaking,
constitute an abuse.

 The consequences of parallel trade for the ultimate consumers

52      The first thing to consider is GSK AEVE’s argument that parallel trade in any event brings only few financial benefits to
the ultimate consumers.

53      In that connection, it should be noted that parallel exports of medicinal products from a Member State where the prices are
low to other Member States in which the prices are higher open up in principle an alternative source of supply to buyers of
the medicinal products in those latter States, which necessarily brings some benefits to the final consumer of those products.

54      It is true, as GSK AEVE has pointed out, that, for medicines subject to parallel exports, the existence of price differences
between the exporting and the importing Member States does not necessarily imply that the final consumer in the importing
Member State will benefit from a price corresponding to the one prevailing in the exporting Member State, inasmuch as the
wholesalers carrying out the exports will themselves make a profit from that parallel trade.

55      Nevertheless, the attraction of the other source of supply which arises from parallel trade in the importing Member State
lies precisely in the fact that that trade is capable of offering the same products on the market of that Member State at
lower prices than those applied on the same market by the pharmaceuticals companies.

56      As a result, even in the Member States where the prices of medicines are subject to State regulation, parallel trade is liable
to exert pressure on prices and, consequently, to create financial benefits not only for the social health insurance funds,
but equally for the patients concerned, for whom the proportion of the price of medicines for which they are responsible will
be lower. At the same time, as the Commission notes, parallel trade in medicines from one Member State to another is likely
to increase the choice available to entities in the latter Member State which obtain supplies of medicines by means of a public
procurement procedure, in which the parallel importers can offer medicines at lower prices.

57      Accordingly, without it being necessary for the Court to rule on the question whether it is for an undertaking in a dominant
position to assess whether its conduct vis-à-vis a trading party constitutes abuse in the light of the degree to which that
party’s activities offer advantages to the final consumers, it is clear that, in the circumstances of the main proceedings,
such an undertaking cannot base its arguments on the premiss that the parallel exports which it seeks to limit are of only
minimal benefit to the final consumers.

 The impact of State price and supply regulation in the pharmaceuticals sector

58      Turning, next, to the argument based on the degree of regulation of the pharmaceuticals markets in the Community, it must
first be examined whether State regulation of the prices of medicinal products has an impact on the assessment of whether
a refusal to supply those products constitutes abuse.

59      It is clear that, in the majority of Member States, medicines, in particular those available only on prescription, are subject
to regulation aimed at setting, at the request of the manufacturers concerned and on the basis of information provided by
them, selling prices for those medicines and/or the scales of reimbursement of the cost of prescription medicines by the relevant
social health insurance systems. The price differences between Member States for certain medicines are thus the result of
the different levels at which the prices and/or the scales to be applied to those medicines are fixed.

60      The main proceedings relate to a non-harmonised area in which the Community legislature has limited itself, in adopting Directive
89/105, to placing Member States under a duty to guarantee that decisions in respect of the regulation of prices and reimbursement
are taken with complete transparency, without discrimination and within certain specific time-limits.

61      In that respect, it should be noted, on one hand, that the control exercised by Member States over the selling prices or the
reimbursement of medicinal products does not entirely remove the prices of those products from the law of supply and demand.

62      Thus, in some Member States, the public authorities do not intervene in the process of setting prices or limit themselves
to setting the scale of reimbursement of the cost of prescription medicines by the national health insurance systems, thereby
leaving to the pharmaceuticals companies the task of deciding their selling prices. Furthermore, even though the public authorities
in other Member States set the selling prices of medicines as well, that does not in itself mean that the manufacturers of
the medicines concerned have no influence upon the level at which the selling prices are set or the proportion of those prices
which is reimbursed.

63      As the Commission has pointed out, even in the Member States where the selling prices or the amounts of reimbursement of medicines
are set by the public authorities, the producers of the medicines concerned take part in the negotiations which are initiated
by those producers and take their price proposals as a starting point and end with the setting of the prices and the amounts
of reimbursement to be applied. As the second and third recitals to Directive 89/105 state, the task of the authorities when
setting prices of medicines is not only to control expenditure connected with public health systems and to ensure the availability
of adequate supplies of medicinal products at a reasonable cost, but also to promote efficiency in the production of medicinal
products and to encourage research and development into new medicinal products. As the Advocate General indicated in points
90 to 93 of his Opinion, the level at which the selling price or the amount of reimbursement of a given medicinal product
is fixed reflects the relative strength of both the public authorities of the relevant Member State and the pharmaceuticals
companies at the time of the price negotiations for that product.

64      On the other hand, it should be recalled that, where a medicine is protected by a patent which confers a temporary monopoly
on its holder, the price competition which may exist between a producer and its distributors, or between parallel traders
and national distributors, is, until the expiry of that patent, the only form of competition which can be envisaged.

65      In relation to the application of Article 85 of the EEC Treaty (Article 85 of the EC Treaty, now Article 81 EC), the Court
has held that an agreement between producer and distributor which might tend to restore the national divisions in trade between
Member States might be such as to frustrate the objective of the Treaty to achieve the integration of national markets through
the establishment of a single market. Thus on a number of occasions the Court has held agreements aimed at partitioning national
markets according to national borders or making the interpenetration of national markets more difficult, in particular those
aimed at preventing or restricting parallel exports, to be agreements whose object is to restrict competition within the meaning
of that Treaty article (see, for example, Joined Cases 96/82 to 102/82, 104/82, 105/82, 108/82 and 110/82 *IAZ International Belgium and Others* v *Commission* [1983] ECR 3369, paragraphs 23 to 27; Case C‐306/96 *Javico* [1998] ECR I‐1983, paragraphs 13 and 14; and Case C‐551/03 P *General Motors* v *Commission* [2006] ECR I‐3173, paragraphs 67 to 69).

66      In the light of the abovementioned Treaty objective as well as that of ensuring that competition in the internal market is
not distorted, there can be no escape from the prohibition laid down in Article 82 EC for the practices of an undertaking
in a dominant position which are aimed at avoiding all parallel exports from a Member State to other Member States, practices
which, by partitioning the national markets, neutralise the benefits of effective competition in terms of the supply and the
prices that those exports would obtain for final consumers in the other Member States.

67      Although the degree of price regulation in the pharmaceuticals sector cannot therefore preclude the Community rules on competition
from applying, the fact none the less remains that, when assessing, in the case of Member States with a system of price regulation,
whether the refusal of a pharmaceuticals company to supply medicines to wholesalers involved in parallel exports constitutes
abuse, it cannot be ignored that such State intervention is one of the factors liable to create opportunities for parallel
trade.

68      Furthermore, in the light of the Treaty objectives to protect consumers by means of undistorted competition and the integration
of national markets, the Community rules on competition are also incapable of being interpreted in such a way that, in order
to defend its own commercial interests, the only choice left for a pharmaceuticals company in a dominant position is not to
place its medicines on the market at all in a Member State where the prices of those products are set at a relatively low
level.

69      It follows that, even if the degree of regulation regarding the price of medicines cannot prevent any refusal by a pharmaceuticals
company in a dominant position to meet orders sent to it by wholesalers involved in parallel exports from constituting an
abuse, such a company must nevertheless be in a position to take steps that are reasonable and in proportion to the need to
protect its own commercial interests.

70      In that respect, and without it being necessary to examine the argument raised by GSK AEVE that it is necessary for pharmaceuticals
companies to limit parallel exports in order to avoid the risk of a reduction in their investments in the research and development
of medicines, it is sufficient to state that, in order to appraise whether the refusal by a pharmaceuticals company to supply
wholesalers involved in parallel exports constitutes a reasonable and proportionate measure in relation to the threat that
those exports represent to its legitimate commercial interests, it must be ascertained whether the orders of the wholesalers
are out of the ordinary (see, to that effect, *United Brands and United Brands Continentaal* v *Commission*, paragraph 182).

71      Thus, although a pharmaceuticals company in a dominant position, in a Member State where prices are relatively low, cannot
be allowed to cease to honour the ordinary orders of an existing customer for the sole reason that that customer, in addition
to supplying the market in that Member State, exports part of the quantities ordered to other Member States with higher prices,
it is none the less permissible for that company to counter in a reasonable and proportionate way the threat to its own commercial
interests potentially posed by the activities of an undertaking which wishes to be supplied in the first Member State with
significant quantities of products that are essentially destined for parallel export.

72      In the present cases, the orders for reference show that, in the disputes which gave rise to those orders, the appellants
in the main proceedings have demanded not that GSK AEVE should fulfil the orders sent to it in their entirety, but that it
should deliver them quantities of medicines corresponding to the monthly average sold during the first 10 months of 2000.
In 6 of the 11 actions in the main proceedings, the appellants asked for those quantities to be increased by a certain percentage,
which was fixed by some of them at 20%.

73      In those circumstances, it is for the referring court to ascertain whether the abovementioned orders are ordinary in the light
of both the previous business relations between the pharmaceuticals company holding a dominant position and the wholesalers
concerned and the size of the orders in relation to the requirements of the market in the Member State concerned (see, to
that effect, *United Brands and United Brands Continentaal* v *Commission*, paragraph 182, and Case 77/77 *Benzine en Petroleum Handelsmaatschappij and Others* v *Commission* [1978] ECR 1513, paragraphs 30 to 32).

74      Those considerations equally deal with the argument raised by GSK AEVE, namely the impact of State regulation on the supply
of medicinal products, and more particularly the argument that undertakings that engage in parallel exports are not subject
to the same obligations regarding distribution and warehousing as the pharmaceuticals companies and are therefore liable to
disrupt the planning of production and distribution of medicines.

75      It is true that in Greece, as is apparent from paragraph 8 of this judgment, national legislation places pharmaceuticals wholesalers
under an obligation to supply the needs of a defined geographical area with a range of pharmaceutical products. It is equally
true that, in cases where parallel trade would effectively lead to a shortage of medicines on a given national market, it
would not be for the undertakings holding a dominant position but for the national authorities to resolve the situation, by
taking appropriate and proportionate steps that were consistent with national legislation as well as with the obligations
flowing from Article 81 of Directive 2001/83.

76      However, a producer of pharmaceutical products must be in a position to protect its own commercial interests if it is confronted
with orders that are out of the ordinary in terms of quantity. Such could be the case, in a given Member State, if certain
wholesalers order from that producer medicines in quantities which are out of all proportion to those previously sold by the
same wholesalers to meet the needs of the market in that Member State.

77      In view of the foregoing, the answer to the questions referred should be that Article 82 EC must be interpreted as meaning
that an undertaking occupying a dominant position on the relevant market for medicinal products which, in order to put a stop
to parallel exports carried out by certain wholesalers from one Member State to other Member States, refuses to meet ordinary
orders from those wholesalers is abusing its dominant position. It is for the national court to ascertain whether the orders
are ordinary in the light of both the size of those orders in relation to the requirements of the market in the first Member
State and the previous business relations between that undertaking and the wholesalers concerned.

**Costs**

78      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 (Grand Chamber) hereby rules:

**Article 82 EC must be interpreted as meaning that an undertaking occupying a dominant position on the relevant market for
medicinal products which, in order to put a stop to parallel exports carried out by certain wholesalers from one Member State
to other Member States, refuses to meet ordinary orders from those wholesalers, is abusing its dominant position. It is for
the national court to ascertain whether the orders are ordinary in the light of both the size of those orders in relation
to the requirements of the market in the first Member State and the previous business relations between that undertaking and
the wholesalers concerned.**

[Signatures]

---

[\*](#Footref*) Language of the case: Greek.