WRITTEN QUESTION E-2830/01 by Bernd Lange (PSE) to the Commission. Implementing provisions for Directive 98/69/EC.
Date: 2001-10-11
Institutions: European Parliament, Provisional data
Subjects: air quality, application of EU law, combustion gases, motor vehicle, roadworthiness tests, technical standard

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 ( 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.

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?

18.4.2002

EN

Official Journal of the European Communities

C 93 E/203

If so, what action will it take?

Would the right approach not be for the Commission to draw up its own specific implementation
provisions for the directive which could then be taken over by the Member States?

(1) OJ L 350, 28.12.1998, p. 1.

Answer given by Mr Liikanen on behalf of the Commission

(29 November 2001)

The Commission has been working steadily to complete the technical requirements of Council Directive
70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to
measures to be taken against air pollution by gases from positive-ignition engines of motor vehicles (1), as
specifically amended by Directive 98/69/EC of the Parliament and of the Council of 13 October 1998. All
Member States have transposed Directive 98/69/EC.

In particular, the Commission services have been working to resolve the issues associated with in-use
compliance checking of vehicles. However, finding a common position between Member States on the
definition of what are termed an ‘outlier vehicle’ (see section 3.1. of Appendix 4 to Annex I of Directive
98/69/EC) has been difficult. This is why this particular aspect of Directive 98/69/EC has not yet been
implemented through an amending directive.

Earlier this year, the Commission presented a package of proposed amendments to Directive 70/220/EEC
to the Committee for Adaptation to Technical Progress (CATP). Amongst other things, this package
completed Appendices 3 and 4 of Annex I to that Directive, concerning in-use compliance checking.
However, since there was no possibilty to complete an agreement on the definition of ‘outlier vehicle’, a
decision on the proposal has been delayed. The Commission now hopes to resolve this issue in the next
meeting of the CATP which is scheduled to be held in the third week of December 2001.

Regarding in-use compliance checking, one can reasonably understand that little, if any, in-use compliance
checking has so far been carried out in Member States. This check applies to vehicles that entered into
service after 1 January 2000 and authorities will wait to target vehicle types for which there are sufficient
examples on the road that have accumulated quite some distance (up to 80,000 kilometer (km)).

The discussions between the European Type-Approval Authorities (TAAM) in Oslo on 7 June 2001 did
discuss the technical content of Directive 98/69/EC, but it was in relation to an interpretation offered by
the KBA (Kraftfahrt-Bundesamt) as to how in-use compliance checking should be carried out on the basis
of the content of Directive 98/69/EC. Authorities are also discussing the procedures for rationalising in-use
compliance checking to avoid duplicate testing of the same vehicle type being carried out in several
Member States. The Member States have the responsibility to apply the Directives accurately and
harmoniously. The meetings of the European Type-Approval Authorities remains a good forum to resolve
problems relating to the common application of the Directives.

(1) OJ L 76, 6.4.1970.

(2002/C 93 E/241)

WRITTEN QUESTION P-2831/01

by Armando Cossutta (GUE/NGL) to the Council

Subject: Racist statements by the Italian Government

(8 October 2001)

According to various diplomatic sources and numerous reports in leading European newspapers, at the
European Council meeting, Silvio Berlusconi, the Italian Prime Minister, stated among other things that the
United States symbolised Western civilisation in contrast to the Islamic way of life; that our civilisation was
superior to others, some of which were still in the middle ages and pointing out, finally, the need to