WRITTEN QUESTION E-0082/04 by Proinsias De Rossa (PSE) to the Commission. Clinical Trials Directive.
Date: 2004-01-20
Institutions: European Parliament, Provisional data
Subjects: Ireland, experiment on humans, medical research, medicinal product, national implementing measure, research policy

3.4.2004

EN

Official Journal of the European Union

C 84 E/159

or may move the persons to a safe place in order to prevent them from continuing their journey, if so
authorised by national law. This shall apply in particular to minors and persons who must be interned
following a decision by a competent authority. The communication of data on a missing person who is of
age shall be subject to the person’s consent.’

According to Article 101 of the Convention, access to these data shall be reserved exclusively to the
authorities responsible for border checks and for other police and customs checks carried out within the
country, as well as to the authorities responsible for the coordination of such checks.

Since the Parties of the Convention are responsible for the management of the Schengen Information
System (SIS), they are in a position to draw conclusions as regards its effectiveness. However,
the
Commission was informed that about 33 000 persons were reported in the SIS further to Article 97 of the
Convention by the end of 2003. About 50 % percent of these persons were minors. The possibility of
circulating data on missing persons under Article 97 was used by all Schengen States, but especially by
Germany, Spain, France, Italy and Portugal.

The Council addressed the issue of a European database for missing persons in its conclusions of 8 May
2003 in the Brussels Declaration on Preventing and Combating Trafficking in Human Beings (2) taking into
consideration the development of the SIS II. The Commission can confirm that the SIS II will be able to
include data on missing persons.

(1) OJ L 239, 22.9.2000.
(2) OJ C 137, 12.6.2003.

(2004/C 84 E/0197)

WRITTEN QUESTION E-0082/04

by Proinsias De Rossa (PSE) to the Commission

(20 January 2004)

Subject: Clinical Trials Directive

Further to the Commission’s response to E-3209/03 and E-3215/03 (1) on implementation of Directive
2001/20/EC (2), what views were presented by the Irish Government representatives at the 15 May 2003
pharmaceutical committee meeting? What progress has been made in the preparation of
the
implementation guidelines for this Directive in the Member States?

(1) OJ C 70 E, 20.3.2004.
(2) OJ L 121, 1.5.2001, p. 34.

Answer given by Mr Liikanen on behalf of the Commission

(23 February 2004)

The Commission is currently working together with the Member States in the preparation of
the
implementing guidelines of this Directive. In this context, the Irish competent authority informed the
Commission that specific guidance for the application of clinical trials will be developed and published
soon.

The Commission discussed a first draft of the implementing guidelines with the Member States during the
Standing Committee meeting held on 23 July 2003. No agreement could be reached during that meeting.
The new draft for the implementing guidelines is still under discussion within the Commission.