WRITTEN QUESTION E-2829/01 by Béatrice Patrie (PSE) to the Commission. Access to new medicinal products.
Date: 2001-10-11
Institutions: European Parliament, Provisional data
Subjects: EU Member State, administrative formalities, application of EU law, fixing of prices, marketing, medicinal product, redemption

18.4.2002

EN

Official Journal of the European Communities

C 93 E/201

(2002/C 93 E/238)

WRITTEN QUESTION E-2821/01

by Stavros Xarchakos (PPE-DE) to the Commission

(10 October 2001)

Subject: Definition of the terms ‘adult’ and ‘minor’

There are different interpretations and definitions in the Member States of the age at which a person is
considered to be an adult or a minor. For example, in some countries in the Union, such as Greece, police
identity cards can be issued to a person under the age of 18, whereas that same person can vote only after
attaining the age of 18 but may, nevertheless, be considered fit for work at the age of 15. The same
definition of age is evidently also recognised by the Commission. Its publication entitled ‘The unity of
Europe, solidarity of the peoples, diversity of the regions 0 Second Report on economic and social
(with a preface by Commissioner Barnier) states (page 16) that the Union’s labour force
cohesion’
comprises individuals aged 15-64, and provides details of the rate of unemployment.

Will the Commission say when an individual is considered to be an adult or a minor in all the other
Member States?

Can the definition be harmonised throughout the EU in order to eliminate the confusion which is caused?

Answer given by Mr Prodi on behalf of the Commission

(20 November 2001)

The issue raised does not fall within the Community’s remit:
authorities only.

it is a matter for the relevant national

(2002/C 93 E/239)

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.

the
Mr Liikanen replied for the European Commission on 3 September 2001 to the effect
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
legislation conformed to the directive but there were
be prepared to intervene even where national
administrative practices that did not comply with the 180-day deadline laid down by Directive
89/105/EEC.

that

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.

C 93 E/202

Official Journal of the European Communities

EN

18.4.2002

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 0 price and reimbursement 0 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.

in its capacity as guardian of

With regard to non-compliance with the procedural guarantees set out in the ‘transparency’ directive, the
is also prepared to intervene and initiate
the Treaties,
Commission,
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
laws might comply but the national administration does not
question. In cases where these national
systematically apply the requirements of
the Commission would take action under
Article 226 of the EC Treaty.

the Directive,

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.

(2002/C 93 E/240)

WRITTEN QUESTION E-2830/01

by Bernd Lange (PSE) to the Commission

(11 October 2001)

Subject: Implementing provisions for Directive 98/69/EC

Complaints are increasingly reaching me of delays in transposing Directive 98/69/EC (1) in a number of
Member States. These delays are affecting the inspection of vehicles already authorised (in use compliance),
since that is where there are still no transposition standards.

The discussions held in this connection at the meeting of the European type approvals authorities on 6
and 7 June 2001 in Oslo had the effect if anything of further delaying the development of European
transposition provisions rather than bringing it forward. Problems are said to have arisen in particular over
efforts to draw up comparable arrangements in the different Member States.

Is the Commission aware of the delays in transposing Directive 98/69/EC?