WRITTEN QUESTION E-1812/01

by Hervé Novelli (PPE-DE) to the Commission

(21 June 2001)

Subject: Directive on transparency and reimbursement of medicinal products

Directive 89/105/EEC(1) on transparency of prices and reimbursement of medicinal products ought to have given patients speedier access to new medicines on the market. Ten years later, statistics show it has had no effect. It has not improved patients' access to new treatments.

There has been no reduction in the time needed to put these products on sale and the time needed to decide on prices and reimbursement very often exceeds the 180 days laid down in the directive, especially in France. The usual reason appears to be over-heavy administration.

If the Commission is concerned to give patients equal access to medicines in the European Union, should it not make the Member States aware of the disparities between one country and another?

Could we not envisage a reform in procedure that would give patients immediate access to new medicines at provisional prices and reimbursement rates, while the Member States and the pharmaceutical industry negotiate the definitive rates?

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

Answer given by Mr Liikanen on behalf of the Commission

(3 September 2001)

The purpose of Directive 89/105/EEC(1), the so-called transparency directive, is to establish a system designed to obtain an overall view of national pricing arrangements for medicinal products, including the manner in which they operate in individual cases and all the criteria on which they are based, and to provide public access to them for all those involved in the market in medicinal products in the Member States. With regard to pricing, constitution of positive lists

of medicinal products covered by the national health insurance system and access to anyone interested in pricing questions, the Directive stipulates precise time limits for procedural safeguards relating to the collection and dissemination of any information on the matter.

In addition, European legislation on medicinal products rests on separating on the one hand the considerations of public authorities on the safety, quality and effectiveness of medicinal products and on the other hand the freedom of the Member States with regard to agreements on pricing and reimbursement in connection with national health insurance schemes. The separation of these two objectives is quite clear. Negotiations on marketing arrangements, including discussions on the pricing of medicinal products, are the responsibility of the Member States. However, in conducting such negotiations the Member States must comply with the procedural safeguards on transparency laid down by Directive 89/105/EEC and with the general principles of the EC Treaty.

The Commission believes that the directive is useful with regard to the transparency of pricing. As for the differences among the Member States concerning arrangements for pricing and reimbursing medicinal products, the Commission currently sees neither any need to standardise nor any possibility of harmonising these arrangements, provided that the procedural safeguards laid down in Directive 89/105/EEC are complied with.

Naturally, the Commission is aware of the concern expressed on account of the discrepancies concerning different arrangements for pricing and reimbursing medicinal products in the Member States and the related delays. Apart from supervising the transparency directive, however, it has only limited powers in this regard. This matter lies at the heart of talks between patients' associations, manufacturers and national authorities. More specifically, it is one of the main topics of discussion by the High Level Group on Innovation and the Provision of Medicines (G10), which met for the first time in March 2001. The purpose of the group is to bring together a small number of leading figures from each of the sectors in question to examine these topics and to endeavour to find solutions. It will present the results of its work to the President of the Commission in May 2002.

As for non-compliance with the overall deadline of 180 days, the Commission as guardian of the Treaties would be ready to act, especially if there were any lack of conformity with regard to the transposition of this requirement in national legislation. As far as the Commission is aware, this is not the case with regard to French legislation. Furthermore, even in instances where national legislation complied with the transparency directive, the Commission could act in the event of any administrative practice failing to comply with the deadline of 180 days laid down in Directive 89/105/EEC.

As for access to new treatments, mention should be made of the creation in 1995 of a centralised Community procedure(2). In this regard, applications to the European Agency for the Evaluation of Medicinal Products are compulsory for all biotechnological products and optional for all other new medicinal products. This centralised procedure supplements the mutual recognition procedure that still applies to most conventional medicinal products. The centralised procedure, which results in marketing authorisation covering the whole of the Community being issued, is designed to give patients speedy access to new treatments. According to a study conducted on behalf of the Commission to assess procedures for the authorisation of medicinal products(3), both the operation of the Agency and the implementation of the centralised procedure have yielded satisfactory results with regard to patients' access to new products.

Lastly, as for the possibility of provisional pricing, there is already provision for this in the last sentences of Articles 2 (1) and 3 (1) of the Directive, whereby applicants may market a product at the price proposed in the absence of any decision by the competent authorities within the time limits laid down in the Directive.

(1) 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 (OJ L 40, 11.2.1989).

(2) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ L 214, 24.8.1993).

(3) Evaluation of the operation of Community procedures for the authorisation of medicinal products, evaluation carried out on behalf of the European Commission, Cameron McKenna - Andersen Consulting, available on http://pharmacos.eudra.org.