WRITTEN QUESTION P-3594/01 by Dorette Corbey (PSE) to the Commission. Threat to the marketing of new drugs in France.
Date: 2002-01-08
Institutions: European Parliament, Provisional data
Subjects: France, United States, dominant position, marketing restriction, medicinal product, pharmaceutical industry, prices policy

20.6.2002

EN

Official Journal of the European Communities

C 147 E/205

(2002/C 147 E/214)

WRITTEN QUESTION P-3594/01

by Dorette Corbey (PSE) to the Commission

(8 January 2002)

Subject: Threat to the marketing of new drugs in France

It was reported in the Financial Times this week that the US drugs company Pfizer is threatening to
withhold new drugs from France unless the French Government allows changes in its pricing regime.
Pfizer is trying to enlist support from other pharmaceutical companies to force up the price of drugs.

What is the Commission’s view of this threat by Pfizer and can it be seen as abuse of a dominant position?

Prices for pharmaceuticals in France are fairly high by European standards and are a benchmark for prices
in other countries. What financial repercussions would a rise in the price of medicines in France have on
their cost in the other 14 Member States?

Does the Commission see Pfizer’s threat as grounds for proposing measures pursuant to Article 95 of the
EC Treaty to achieve the objective of Article 153(1) of the EC Treaty under which, among other things, the
Community is to contribute to protecting the health, safety and economic interests of consumers? Does
Pfizer’s threat give grounds for envisaging a European pricing policy for medicines or other measures?

Answer given by Mr Liikanen on behalf of the Commission

(1 February 2002)

There is no Community legislation in the matters related to the pricing and reimbursement of medicinal
products. The Member States have, however, when taking decisions on these issues,
the
transparency requirements set up by Council Directive 89/105/EEC of 21 December 1988, relating to the
transparency of measures regulating the pricing of medicinal products for human use and their inclusion
in the scope of national health insurance systems (1).

to fulfil

Even if the Community pharmaceutical
legislation provides for an obligation of authorisation by a
competent authority of any medicinal product, which is to be put on the market, no requirement is
imposed concerning the obligation of an effective marketing of the authorised medicinal product. This
decision lies with the marketing authorisation holder.

The prices of medicinal products in France are not usually considered as the highest ones in the
Community. In any event, a rise in the price in one Member State does not have automatic consequences
in the prices of the same medicinal product in the other fourteen Member States. The price reference
system, as a way of fixing the price of a medicinal product, is not applied in all the Member States;
whenever this price reference system is used, it can be used in different ways in the Member States.

The Commission does not envisage, at this stage, any new Community legislation, based on Article 95 (ex
Article 100a) of
the EC Treaty, which will establish a Community policy concerning pricing and
reimbursement systems. The Commission does envisage the preparation of a report on the application of
Council Directive 89/105/EEC, which may bring to certain conclusions aiming at an improvement of the
functioning of this Directive. In this same context, the G-10 exercise, which brings together representatives
from the pharmaceutical industry, patients, health national systems, national ministries and the Members
of the Commission responsible for Health and Consumer Protection and for Enterprises, has already
pointed to the need to improve the functioning of the national systems for the decisions on pricing and
reimbursement in order to ensure a greater uniformity and a quicker overall access of the pharmaceutical
products to the market.

C 147 E/206

Official Journal of the European Communities

EN

20.6.2002

Finally, the potential application of Article 82 (ex Article 86) of the EC Treaty (abuse of a dominant
position) would require the analysis of various factors. First, for each product concerned, the relevant
market should be defined following the principles set out in the case law of the European Courts and in
the Commission’s practice in antitrust cases. Then it should be assessed whether or not Pfizer is dominant
in this (these) relevant market(s). Only in those cases where Pfizer was dominant could the Commission
assess the existence of any abuse. On the basis of the available information, the Commission is not in a
position to conclude on any of these issues, even on a provisional basis.

(1) OJ L 40, 11.2.1989.

(2002/C 147 E/215)

WRITTEN QUESTION P-3596/01

by Pietro-Paolo Mennea (PPE-DE) to the Commission

(8 January 2002)

Subject: Environmental problem in the Prima Cala area in Molfetta

There have been numerous reports in the local and national press and many complaints from alarmed
residents about a ‘serious’ environmental problem following the building of the Scoglio di Inghilterra lido
in the Prima Cala area of the town of Molfetta.

According to the information available, the construction of this bathing beach complex involved the
extensive A and, indeed, excessive A use of concrete, which has totally disfigured the area, robbing it of its
natural features.

This situation has been brought to the notice of the local authorities and the harbour master’s office, who
are responsible for the area, but no action has been taken to repair the damage caused.

Given the above, would the Commission carry out an in-depth investigation into the matter with a view to
determining once and for all whether all the relevant environmental and legal requirements were met
when planning permission was granted?

Furthermore, with a view to monitoring the situation along Italy’s coastline, would it not agree that an
inventory should be made of all areas where the excessive use of concrete remains a problem?

Answer given by Mrs Wallström on behalf of the Commission

(25 January 2002)

According to Article 2 of Council Directive 85/337/EEC of 27 June 1985, on the assessment of the effects
of certain public and private projects on the environment (1) (EIA) and Council Directive 97/11/EC of
3 March 1997 (2) which has modified Directive 85/337/EEC, Member States are obliged to ensure that,
before consent is given, projects likely to have significant effects on the environment by virtue, inter alia,
of their nature, size or location are made subject to a requirement for development consent and an
assessment with regard to their effects. Classes of projects relevant to the directive are defined in Article 4
and listed in the first two annexes. However, on the basis of the information given by the Honourable
Member, it is not possible to assess whether the project mentioned by the Honourable Member falls within
one of the classes listed in the annexes of the directive.

Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna
and flora (3) provides that measures are taken to maintain or restore, at favourable conservation status,
natural habitats and species of wild fauna and flora of Community interest. These measures are to be
applied within the special areas of conservation included in the network set up under the title Natura
2000, as identified in accordance with the procedure laid down in Article 4. However, on the basis of the
information given by the Honourable Member it appears that the project mentioned by the Honourable
Member does not fall within any relevant area under the Directive.