WRITTEN QUESTION E-1812/01 by Hervé Novelli (PPE-DE) to the Commission. Directive on transparency and reimbursement of medicinal products.
Date: 2001-06-21
Institutions: European Parliament, Provisional data
Subjects: access to information, fixing of prices, health insurance, medicinal product, redemption, right to health

14.2.2002

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Official Journal of the European Communities

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In the light of this development, is the Commission planning to come forward with proposals for an EU-
wide ban on the marketing of products made from dogs and cats and the export from the Union of such
goods?

Answer given by Mr Lamy on behalf of the Commission

(3 September 2001)

The United States (US) bill HR 4868 pertaining to prohibition on importation and other trade in products
made with cat and dog furs entered into force on 9 November 2000. It aims to impose a ban on the sale,
manufacture, offer for sale, transportation and distribution of cat and dog fur products, regardless of their
source (the only exception applies to import, export and transportation for non-commercial purposes of a
personal pet deceased, including a pet preserved through taxidermy). It is a domestic ban with an external
trade dimension.

On the question whether the Commission plans to come forward with proposals for a Community-wide
ban, it should be recalled that trade policy is only an outward projection of the internal policy of the
Community. Given that the principle of subsidiarity should apply on such sensitive policy matters, within
the limits set by the EC Treaty with regard to the free movement of goods and that no Member State has
adopted legislation to prohibit the sale, manufacture, transportation and distribution of cat and dog furs
within its own territory, the Commission does not believe that the issue of sale of cat and dog furs
warrants any legislative initiative in the Community at this stage.

(2002/C 40 E/109)

WRITTEN QUESTION E-1812/01

by HervØ 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(cid:146) 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 (cid:145)transparency(cid:146) 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

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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 Member States with regard to agreements on pricing and
the other hand the freedom of
reimbursement
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.

in connection with national health insurance schemes. The separation of

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 (cid:145)transparency(cid:146) directive, however, it has only limited powers in
this regard. This matter lies at the heart of talks between patients(cid:146) 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
(cid:145)transparency(cid:146) 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 (cid:145)mutual recognition(cid:146) 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(cid:146) 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).
(cid:145)Evaluation of the operation of Community procedures for the authorisation of medicinal products(cid:146), evaluation
carried out on behalf of the European Commission, Cameron McKenna (cid:129) Andersen Consulting, available on http://
pharmacos.eudra.org.

(3)