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, to fulfil 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).

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.

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.