This presentation contains an overview of recent Greek jurisprudence on parallel trade in the pharmaceutical industry. Contents include circulars, laws and recent case studies.

1. Parallel Trade in the Pharma Industry Overview
Recent Greek Jurisprudence
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2. Parallel Trade : EU Fundamental Freedoms & National Legislation
• Freedom TO OPERATE / TO CONTRACT
• FREE MOVEMENT OF GOODS (ART. 28-29 &34-35 TFEU)
• ART. 36 EXCEPTION FOR PUBLIC POLICY GROUNDS (eg. Protection of Health)
• FREE COMPETITION (ART. 101 TFEU)
• ABUSE OF DOMINANT POSITION (ART. 102 TFEU)
• EOF Circular 66249/8.11.2005
Producers, importers, representatives and medical warehouses must supply
pharmacies and treatment centers of all categories with substance quantities which
ensure a 25% security surplus.
• Law 4238/17.2.2014
…foresees up-to-€1m penalties for pharmaceutical companies and wholesalers which
do not comply with parallel trade legislation or who induce local market deficiencies.

3. ECJ Jurisprudence
ECJ C53/03: SYFAIT vs. GLAXO GREECE
The ECJ recalled 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 102 TFEU where, without any objective
justification, that conduct is liable to eliminate a trading party as a competitor”
BUT under which conditions the REFUSAL TO SUPPLY by an undertaking in a
DOMINANT POSITION may amount to an abuse?
“It is permissible for a company to counter in a reasonable and proportionate way the threat to its commercial
interests potentially posed by the activities of a wholesaler which wished to be supplied with significant quantities
of products that are essentially destined for parallel exports” (points 69 and 71)
The Court further held that a pharmaceutical company must therefore be able to protect itself against orders
that are out of the ordinary in terms of quantity (point 70 and 76)
This must be assessed in the light of both
(i) the previous business relations between the pharmaceuticals company and the wholesalers concerned and
(ii) the size of the orders in relation to domestic demand (point 73)
→ a company, even in dominant position, can protect its legitimate commercial
interests by refusing orders which are “out of the ordinary” in respect of (i) the history
of orders and (ii) the size in relation to domestic demand.

4. ECJ Jurisprudence
ECJ 2008/12: LELOS & Sia EE and Others vs. GLAXO SMITH KLINE
The ECJ ruled that the refusal to supply by a dominant undertaking falls indeed
ambit of Article 102 TFEU but it should be examined if the undertaking has
objective reasons for this refusal and not as reasonable & proportionate
measure in defense of its commercial interests (and not as its primary intent).
The ECJ also examined whether GSK conduct was harmful for final customers by
abusing its dominant position.
An undertaking abuses its dominant position where, in order to restrict
parallel exports, it refuses to meet orders which are “out of the ordinary in
terms of quantity” and “are out of all proportion to those previously sold by
the same wholesaler to meet the needs of the national market”.
A manufacturer may refuse an individual order when it either exceeds what
the particular wholesaler used to order in the past, or when the total
aggregate amount of the orders in the national market already have exceeded
the aggregate domestic consumption.

5. Greek Jurisprudence
Athens High Court 1355/2011
Farmaservis (Pharma Wholesaler) vs. Astra Zeneca
Farnaservis Arguments:
AZ didn’t meet its contractual obligations to purchase Farmaservis adequate
quantities during 2009
AZ purchased pharmacists DIRECTLY aiming to substitute Farmaservis in the
market
AZ abused its dominant market position
Astra Zeneca Arguments:
The company delivered all adequate quantities (based on IMS data) in order for the
patients’ needs to be met.
AZ delivers specific quantities sufficient to demand and in order to meet both the
local needs based on its QMS system calculated on local market needs (IMS data)
according last years’ market needs, seasoning, wholesaler’s expansion (calculated
on 15% average) always covering expected demand by 25%
It does not hold any dominant position in the local market

6. Greek Jurisprudence
Judgment:
The quantities of the drugs sold have been calculated by the objective distribution system
(IMS)
The non fulfillment of unusual demands does not constitute denial but is justifiable given
that AZ’s scope has been to objectively distribute drugs to ALL the wholesalers in Greece
The quantities ordered by Farmaservis has been proven that were destinated to be
exported
A producer is in position to defend his commercial interests given unusual demands, as
these are defined by previous claims

7. Athens High Court 6373/2012
SyfakSynPe (Pharma Wholesalers’ Partnership in Crete) vs. Pfizer
SyfakSynPe Arguments:
Pfizer didn’t meet its contractual obligations to purchase adequate quantities
during 2010 in comparison with previous years), given a 20% demand increase
By this practice, the needs of the pharmacists have NOT been met
Pfizer abused its dominant market position
Pfizer Arguments:
The company delivered all adequate quantities (based on IMS data) in order for the
patients’ needs to be met.
Pfizer delivers specific quantities sufficient to meet both the local needs and also
cover a 25% monthly security surplus
It does not hold any dominant position in the local market
SyfakSynPe has ordered (without justification) uncommonly high quantities for
pharmacies (1,5-2,5 times over the usual orders) and well-above the national
demand (up 13% from 2010 figures).
Greek Jurisprudence

8. Judgment:
The quantities of the drugs sold have been calculated by the objective
distribution system (IMS)
The non fulfillment of unusual demands does not constitute denial but is
justifiable given that PZ’s scope has been to objectively distribute drugs to
ALL the wholesalers in Greece
The quantities ordered by Farmaservis were destinated to be exported
A producer is in position to defend his commercial interests given unusual
demands, as these are defined by previous claims
Greek Jurisprudence

9. Some OBJECTIVE FACTS to be taken into account are:
 THE BUSINESS RATIONALE as long as the supply & distribution system is
fair & non-discriminatory and serves the local demand
 THE REASONABLE CHARACTER OF THE ENVISIONED SOLUTION along with
an objective method for distributing the available quantities to
wholesalers
 THE TEMPORARY CHARACTER OF EXCEPTIONAL MEASURES LINKED TO
SHORTAGES
BUT: Jurisprudence on the above cases is based on particular & proven facts,
relationships, circumstances etc.
Conclusion