WRITTEN QUESTION E-2961/02 by Giovanni Pittella (PSE) to the Commission. Italian pharmacy system.
Date: 2002-10-22
Institutions: European Parliament, Provisional data
Subjects: Italy, dominant position, exclusive distribution agreement, medicinal product, monopoly, pharmacy, restriction on competition, right of establishment

8.5.2003

EN

Official Journal of the European Union

C 110 E/135

Answer given by Mr Fischler on behalf of the Commission

(31 October 2002)

Article 12 of Commission Regulation (EC) No 1019/2002 of 13 June 2002 on marketing standards for
olive oil (1) makes the Regulation applicable from 1 November 2002,

with certain exceptions:

(cid:1) products marketed before 1 August 2002 can be sold until their use-by date

(cid:1) Article 3 (additional information on category), Article 5 (optional indications) and Article 6 (labelling of

mixtures of oils and of foodstuffs in olive oil) apply from 1 November 2003.

Article 4 on indication of origin on labels was in fact applicable from 1 July 2002. It takes over without
alteration and hence ensures the continuity of the arrangements already introduced by Commission
Regulation (EC) No 2815/1998 of 22 December 1998 concerning marketing standards for olive oil (2).

In response to requests from within the sector the Commission is looking into the advisability of amending
Article 12 of Regulation (EC) No 1019/2002 so as to extend the deadline for compliance with Article 2 on
requirements pertaining to direct sale of olive oil by producers to consumers and grant an additional
period for using up the labels in stock.

Lastly, the Honourable Member is informed that the Commission continues its policy of stepping up the
policing that already exists based on estimation of the yields of the homogeneous zones, establishment of
the geographical information system for olive cultivation and exclusion of production from new plantings,
in the aim of obtaining the best picture of the true production of mills. The purpose of these measures and
of the important changes introduced in the marketing standards Regulation is to reduce the scope for
fraud and improve the quality of the olive oil sold to the final consumer.

(1) OJ L 155, 14.6.2002.
(2) OJ L 349, 24.12.1998.

(2003/C 110 E/154)

WRITTEN QUESTION E-2961/02

by Giovanni Pittella (PSE) to the Commission

(22 October 2002)

Subject: Italian pharmacy system

The structure of the pharmacy sector in Italy has certain notable features:

(cid:1) only pharmacists are authorised to sell pharmaceuticals (of any kind) to the public;

(cid:1) pharmacy numbers are restricted on the basis of the number of inhabitants and the distance between

pharmacies in a given locality;

(cid:1) access to ownership of pharmacies is restricted. More particularly, as regards the transfer of
pharmacies by inheritance, Italian law is conducive to pharmacies being kept within a family in that
it allows descendants in the direct line up to the second degree to retain possession of the pharmacy
until the age of thirty, or for ten years in the case of someone studying pharmacy at university.

In view of this, does the Commission not consider the provisions of Italian law to be incompatible with
the EC Treaty since they actually mean that individual undertakings (cid:1) in this case pharmacies (cid:1) can wield
a monopoly and abuse their position to the detriment of patients and consumers?

C 110 E/136

Official Journal of the European Union

EN

8.5.2003

Does the Commission not consider that the exclusive sale by pharmacies of over-the-counter drugs, which
could be sold via other channels, and the fixing of quotas on pharmacy numbers in order to guarantee the
income levels of pharmacists, are blatant examples of distortion of competition rules?

Answer given by Mr Bolkestein on behalf of the Commission

(12 December 2002)

The Commission notes first of all that the Honourable Member’s questions concern issues of a general
nature which involve most Member States. As it has already stated in answer to a previous written
question on the monopolistic system of regulating chemists’ shops in Italy (1), the Commission is of the
opinion that national measures such as the monopoly position enjoyed by chemists for sales of over-the-
counter medicinal products, and geographic and demographic criteria determining the opening of
chemists’ shops, ‘are not contrary to the principle of freedom of establishment provided for in Article 43 of
the EC Treaty insofar as they are applied in a non-discriminatory manner and are in proportion to their
purpose’.

The Commission is also of the opinion that according to the relevant case law of the Court of Justice (2),
allowing a product to be sold exclusively by pharmacies would not prevent access to the national market
infringe Article 28 of the EC
of pharmaceuticals from other Member States and would not, therefore,
Treaty. This also applies to the limiting of the number of pharmacies and their national distribution, unless
their distribution is likely to compromise the satisfactory supply of pharmaceuticals to consumers,
in
which case they could prove incompatible with Articles 28 to 30 of the EC Treaty.

However, the Commission needs more information in order to make a full analysis of the various rules on
this subject, particularly from the points of view of Articles 28, 43 and 49 of the EC Treaty. It therefore
intends to send a request for information soon to the Italian authorities specifically regarding the points
mentioned by the Honourable Member.

As regards the application of competition rules, even though on the surface it might appear that the
measures referred to constitute unfair competition, Community competition rules do not apply. Article 81
of the EC Treaty would apply only if the practices referred to by the Honourable Member resulted from
the independent decisions or agreements of the Order of Pharmacists, which is not the case. As for
Article 82 of the EC Treaty, it would have to be shown that pharmacists are collectively in a dominant
position. However, given that the structural links between them are insufficient, pharmacists cannot be
considered as occupying a collective dominant position within the meaning of Article 82 of the EC Treaty.

In any event, the Commission is aware of the situation identified by the Honourable Member and will
continue to monitor developments. The Commission will, in particular, take action against any conduct
contrary to Articles 81 and 82 of the EC Treaty.

(1) See the Commission’s answer to written question E-3247/98 by Mr Caccavale, OJ L 320, 6.11.1999.
(2)

Judgment of 29.6.1995.

(2003/C 110 E/155)

WRITTEN QUESTION E-2965/02

by Konstantinos Hatzidakis (PPE-DE) to the Commission

Subject: Television station providing information to farmers

(22 October 2002)

Funds were made available under the Second Community Support Framework and on the initiative of the
Greek Minister for Agriculture to set up a television station designed to provide Greek farmers with
information relating to their work.