WRITTEN QUESTION E-0081/00 by Alexandros Alavanos (GUE/NGL) to the Commission. Proposals for amending Directive 85/374/EEC on liability for defective products.
Date: 2000-01-24
Institutions: European Parliament, Provisional data
Subjects: EU policy, Greece, consumer movement, producer's liability, public hearing

3.10.2000

EN

Official Journal of the European Communities

C 280 E/173

laborious process can mean that several years elapse before European patients, unlike their American
counterparts, can join such early access programmes, therefore denying them the possible benefits of
promising new treatments, which in the case of HIV patients, for example, can mean the difference
between a good quality of life and, at worst, death.

Will the Commission consider drawing up proposals to amend present legislation in order to allow the
European Medicinal Evaluation Agency to represent the 15 Member States when negotiating early access
programmes with the pharmaceutical industry, thereby closing the gap and ending the disparity between
European and American patients?

Answer given by Mr Liikanen on behalf of the Commission

(9 February 2000)

Most of the Member States have laid down procedures to allow patients with serious illnesses to have
access in particular to medicinal products for which marketing authorisation has not yet been given. There
are no Community rules and the above procedures are not harmonised. However, for medicinal products
which are able to use the centralised procedure provided for in Council Regulation 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 (1), when the application for authorisation to place a product in the market is ready,
the applicant has the possibility of submitting the application to the European Agency for the Evaluation
of Medicinal Products where a Community evaluation is carried out to enable the Commission to issue a
marketing authorisation which is valid in all Member States and with identical information in the eleven
languages. In the framework of the review of the marketing authorisation procedures planned for the year
2000, which are likely to lead to proposals for amendments of the current rules in 2001, the Commission
could consider proposing harmonisation of the access to new major medicinal products once there are
sufficient safety and efficacy data to allow this. The evaluation of those data could take place as part of a
centralised evaluation with the possibility of a continuing review as supplementary data become available.

(1) OJ L 214, 24.8.1993.

(2000/C 280 E/197)

WRITTEN QUESTION E-0081/00

by Alexandros Alavanos (GUE/NGL) to the Commission

(24 January 2000)

Subject: Proposals for amending Directive 85/374/EEC on liability for defective products

With a view to improving Directive 85/374/EEC (1) on liability for defective products the Commission
called on (cid:145)interested parties(cid:146) to submit their comments on questions raised in the Green Paper on liability
for defective products before the expiry of a period of four months from the date of publication of the
Green Paper. As the Green Paper itself states: (cid:145)The announcement of this move (cid:133) naturally aroused the
interest of the economic operators, consumers and public administrations(cid:146).

Does the Commission consider that the response of the economic operators and public administra-

1.
tions in the Member States to the questions in the Green Paper has been satisfactory?

From which Greek consumer organisations has it received comments? Did the General Secretariat for

2.
Consumers respond?

(1) OJ L 210, 7.8.1985, p. 29.

C 280 E/174

Official Journal of the European Communities

EN

3.10.2000

Answer given by Mr Bolkestein on behalf of the Commission

(7 March 2000)

The Commission can inform the Honourable Member that it has received nearly 100 comments on

1.
the green paper (1).

Replies emanate from national and European consumer organisations, sectors of industry concerned (in
particular pharmaceuticals, cars, insurance, chemicals, agricultural products, electrical equipment), public
administrations of Member States (Denmark, Germany, Greece, France, Austria, Portugal, Finland, United
Kingdom) and third countries (Iceland, Norway, Slovenia, Switzerland) and bodies specialising in product
liability (e.g. Pan-European organisation of personal injury lawyers, United States Defense research institute,
Special committee on European product liability law).

The Commission published the comments on the Internet (http://europa.eu.int/internal_market/en/goods/
liability/replies.htm).

At this stage, it is premature to judge the substance of the replies.

2.

No reaction has so far been received from any Greek consumer organisation.

(1) COM(99) 396 final.

(2000/C 280 E/198)

WRITTEN QUESTION E-0082/00

by Alexandros Alavanos (GUE/NGL) to the Commission

Subject: Lack of transparency in respect of projects funded by the EU

(24 January 2000)

Article 61 of the contract for the construction of the Attica highway (Elefsina Avenue (cid:129) Stavros (cid:129) Spata
Airport) contains the term (cid:145)confidentiality(cid:146) and stresses that (cid:145)the contracting parties specifically agree and
accept that all information, correspondence, documents, plans, (cid:133) are confidential and shall not be given
to any third party, or be reproduced in any manner or be published in any form(cid:146) and that (cid:145)the obligation
of confidentiality shall obtain for the entire duration of the contract and shall continue for a period of
three years following the expiry thereof(cid:146).

Given that the requirement that public works and supplies contracts cofunded by the European Union
should be fully transparent applies generally and also that comparable terms may exist in other contracts
or may constitute a precedent for future practice, will the Commission say:

1. How will it ensure the transparency of funding and the proper implementation of projects which are

cofunded?

2. Does the above-mentioned (cid:145)confidentiality(cid:146) clause also apply to the Commission?

3. Will Article 61 of Law 2445/96 not make it difficult to trace the causes of the recent collapse of the

bridge on the Attica highway?

4. What measures does it intend to take to remove the unacceptable wording of Article 61 which refers

to (cid:145)confidentiality(cid:146) and the (cid:145)non-publication(cid:146) of information?

Answer given by Mr Bolkestein on behalf of the Commission

(9 March 2000)

On the basis of the information available to the Commission, the confidentiality clause in the text quoted
by the Honourable Member refers to relations between the parties to the concession contract, i.e. the State
and the enterprises to whom the contract in question has been awarded. This provision in no way affects