WRITTEN QUESTION E-2829/01

by Béatrice Patrie (PSE) to the Commission

(11 October 2001)

Subject: Access to new medicinal products

Mr Hervé Novelli tabled Written Question E-1812/01(1) to the Commission on 8 June 2001 on the need to give European patients speedier access to new medicines on the market. He pointed out that Directive 89/105/EEC(2), the so-called transparency directive, had not borne fruit in terms of reducing either the time needed to put these products on sale or the time needed to decide on prices and reimbursement, which very often exceeded the 180 days laid down in the directive. He suggested that the European Commission should be proactive in raising Member States' awareness of the disparities between one EU country and another, and proposed a reform in procedure that would give patients immediate access to new medicines at provisional prices and reimbursement rates.

Mr Liikanen replied for the European Commission on 3 September 2001 to the effect that the Commission was aware of the concern expressed at the discrepancies in price-fixing and levels of reimbursement in Member States and the associated time-lags, but that, apart from management of the transparency directive, the Commission's powers were limited. He also stated that the Commission would be prepared to intervene even where national legislation conformed to the directive but there were administrative practices that did not comply with the 180-day deadline laid down by Directive 89/105/EEC.

Consequently, in confronting the very real difficulties and disadvantages experienced by European patients as a result of disparities between Member States and the length of administrative procedures that operate in some of them as barriers to the rapid marketing of new medicinal products, what practical action will the European Commission take?

(1) OJ C 40 E, 14.2.2002, p. 109.

(2) OJ L 40, 11.2.1989, p. 8.

Answer given by Mr Liikanen on behalf of the Commission

(27 November 2001)

Directive 89/105/EEC(1), which is known as the transparency Directive, only offers procedural guarantees within specified deadlines for fixing the prices and levels of reimbursement for medicinal products. The negotiation of marketing conditions price and reimbursement is a matter for the Member States in compliance with the conditions imposed by Directive 89/105/EEC and the rules of the EC Treaty, particularly those in Articles 28 (ex-Article 30), 29 (ex-Article 34) and 30 (ex-Article 36) of the Treaty.

Under the current circumstances, the Commission does not think it either necessary or possible to harmonise the arrangements for fixing and reimbursing the price of medicinal products.

As the Honourable Member points out, the Commission is aware of the concern expressed at the time-lags associated in certain Member States with these procedures for price-fixing and levels of reimbursement. This issue is one of the topics for discussion within the High level group on innovation and the provision of medicines, which seeks to bring together a limited number of leading figures from each of the sectors concerned to examine these questions and try and find innovative solutions. In addition, the Commission will not fail to take action against Member States, under the procedure in Article 226 (ex-Article 169) of the EC Treaty and under Articles 28 to 30.

With regard to non-compliance with the procedural guarantees set out in the transparency directive, the Commission, in its capacity as guardian of the Treaties, is also prepared to intervene and initiate infringement proceedings under Article 226 of the EC Treaty. At present, there are two cases already before the Court of Justice concerning national legislation which does not comply with Directive 89/105/EEC; these are cases C-2000/229 and C-1999/424 and have been brought against Finland and Austria respectively. At the same time, the Commission is examining and discussing with the other Member States all changes in their national legislation which might lead to problems in complying with the directive in question. In cases where these national laws might comply but the national administration does not systematically apply the requirements of the Directive, the Commission would take action under Article 226 of the EC Treaty.

Generally speaking, the Commission's actions are limited in this field by the very general wording of Directive 89/105/EEC. Discussions are in progress mainly, but not exclusively, within the aforementioned high level group in order to assess whether amendments need to be introduced to clarify certain provisions in this text.

(1) 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 L 40, 11.2.1989.