WRITTEN QUESTION P-0080/00 by Mary Banotti (PPE-DE) to the Commission. European Medicinal Evaluation Agency (EMEA).
Date: 2000-01-18
Institutions: European Parliament, Provisional data
Subjects: EU policy, market approval, medicinal product

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Official Journal of the European Communities

EN

3.10.2000

(2000/C 280 E/195)

WRITTEN QUESTION E-0078/00

by Bart Staes (Verts/ALE) to the Commission

(24 January 2000)

Subject: European initiatives to celebrate the work of the writer Giovannino Guareschi

The books of the writer, journalist, illustrator and humorist Giovannino Guareschi, which include (cid:145)Favola
di Natale(cid:146) ((cid:145)Christmas Story(cid:146)), written while he was held in a Nazi concentration camp in December 1944,
and the Don Camillo stories, written after the war, have been translated into almost all of the official
languages of
the European Union, as well as into Icelandic, Serbo-Croat, Vietnamese, Arabic and
Lithuanian.

Guareschi(cid:146)s books, writings, cartoons and other works, all of which seek to uphold individual freedoms
and human dignity and to combat totalitarianism in all its forms (from Nazism and Fascism to Stalinist
Communism), form a vital part of Europe(cid:146)s cultural heritage.

In recent years, in places such as Roncole Verdi (Parma), Brescello (Reggio Emilia) and Fontanelle (Parma),
private citizens and public bodies have set up museums, permanent exhibitions and trails to guide tourists
around the (cid:145)Little World(cid:146) (cid:129) the Lower Emilia area of the Po Valley, where Guareschi set his stories.

How does the Commission view the idea of funding cultural projects involving town twinning arrange-
ments and other initiatives between various European countries, aimed at bringing Giovannino Guareschi
and his work to the attention of a new audience?

What are its views on the establishment of a (cid:145)Giovannino Guareschi European Prize(cid:146), sponsored by the
European Union and aimed at artists and humorists whose work makes use of Guareschi(cid:146)s traditional tools
of humour and satire to promote freedom of thought and uphold human dignity?

Answer given by Mrs Reding on behalf of the Commission

(28 February 2000)

The Commission may grant support for cultural initiatives only within the framework and according to the
criteria of its existing programmes.

The Commission wishes to draw the attention of the Honourable Member to the fact that, in the course
of March 2000, a call for proposals relating to the first (cid:145)Culture 2000(cid:146) framework programme will be
published in the Official Journal, with Internet consultation also possible.

In the context of the (cid:145)Culture 2000(cid:146) programme, funding earmarked for the field of books, reading and
translation will probably account for around 11 % of the annual budget. Cultural operators hoping to
obtain financial support will thus have an opportunity to present projects in line with the programme(cid:146)s
conditions and criteria.

As far as a prize is concerned, the Honourable Member is advised that, as provided for by the programme,
the Commission will give due consideration to this idea and others, in the course of the year, with a view
to establishing a coherent policy for (cid:145)European cultural prizes(cid:146).

(2000/C 280 E/196)

WRITTEN QUESTION P-0080/00

by Mary Banotti (PPE-DE) to the Commission

(18 January 2000)

Subject: European Medicinal Evaluation Agency (EMEA)

Given that (cid:145)early access programmes(cid:146) for new medicinal products are at present subject to national
legislation, which results in serious delays as fifteen different authorities negotiate with pharmaceutical
companies, compared to the USA, where one central authority, the FDA, grants such access and that this

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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.