WRITTEN QUESTION E-2326/02 by Daniel Varela Suanzes-Carpegna (PPE-DE) to the Commission. Community responsibility for conservation measures.
Date: 2002-07-26
Institutions: European Parliament, Provisional data
Subjects: EU law - national law, application of EU law, common fisheries policy, conservation of fish stocks, fishery resources, fishing regulations, management of resources, national law, territorial waters

C 192 E/58

Official Journal of the European Union

EN

14.8.2003

The provisions on the data protection do not lead to a publication or public accessibility of the data
submitted by the first company. The documentation on safety and efficacy of the reference product is
submitted by the first company to the competent authority. It remains within the authority and is not
disclosed. As a principle, neither generic companies nor the public have access to this data.

For a generic application, it is not necessary that the company actually holds this data.

The generic applicant
the necessary
bioequivalence studies with his generic product. He then submits the required documentation on the
bioequivalence as well as on the quality of the generic product to the competent authority.

the reference product and uses them for

takes samples of

(2003/C 192 E/056)

WRITTEN QUESTION E-2326/02

by Daniel Varela Suanzes-Carpegna (PPE-DE) to the Commission

Subject: Community responsibility for conservation measures

(26 July 2002)

In its proposals for a reform of the Common Fisheries Policy (CFP) which were adopted by the College of
Commissioners on 28 May 2002, the Commission confers new powers on the coastal states to enable
them to devise technical measures applicable in the waters under their jurisdiction which would require
only the Commission’s authorisation. Specifically, the coastal Member States would be allowed to adopt
rules applicable within the knot 0 to 12-mile zone to all vessels and emergency measures applicable in
other zones to all Community vessels.

In view of the fact that there is already a Community procedure enabling the Commission to adopt short-
term emergency measures which are subsequently submitted for ratification by the Council, what reasons
justify the creation of this new procedure?

Does the Commission believe the transfer of such powers to the coastal states to be in accordance with
current Community law? If so, on the basis of what legal precepts?

Lastly, does the Commission not think that it should be the one to adopt such measures, in order to
uphold the principle of neutrality?

Answer given by Mr Fischler on behalf of the Commission

(16 September 2002)

In the Honourable Member’s written question,
it is referred to Articles 8 and 9 of the Commission
proposal. Article 8 provides for Member States emergency measures and Article 9 for Member States
measures within the 12 nautical mile zone.

As Article 8 provides for short-term emergency measures, Article 9 provides for measures in the 12-mile
zone which do not have this urgent feature. It is not a new procedure since this is at the present time
stated in Article 46 of Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of
fishery resources through technical measures for the protection of juveniles of marine organisms (1), indeed
with a different formulation (it applies to ‘local stocks’) but similar in its effect.

Of course, there is a difference between this Article 46 and Article 9 as proposed, since Article 46 does not
apply to vessels from other Member States. But the Commission is of the opinion that restrictive measures
for conservation and management within this zone must not apply only to vessels from the coastal
Member State concerned but also, in order to have a full effect, to the other vessels entitled to fish in this
area.

14.8.2003

EN

Official Journal of the European Union

C 192 E/59

It is stated that such measures must be non-discriminatory and, in this aim, procedural safeguards have
been laid down in this Article.
In particular, authorities of the other Member States concerned are
associated to this procedure (see second indent of paragraphs 1 and 2). Member States and the relevant
Regional Advisory Councils may submit their written comments to the Commission and the Commission
shall confirm the measure or cancel it within 15 working days. Member States may refer the Commission’s
decision to the Council which by a qualified majority may take a different decision.

That provision must not be construed as a transfer of power. According to the principle of proportionality
enshrined in Article 5 of the EC Treaty, any action by the Community shall not go beyond what is
necessary to achieve the objectives of the EC Treaty. In that sense, the Commission is of the opinion that
measures concerning conservation and management of resources within this area and having not yet been
taken by the Community can be correctly and wisely addressed by the coastal Member State concerned.

As regards compliance of these measures with a principle of neutrality, the procedural safeguards above-
mentioned allow it effectively.

(1) OJ L 125, 27.4.1998.

(2003/C 192 E/057)

WRITTEN QUESTION E-2350/02

by Alexandros Alavanos (GUE/NGL) to the Commission

Subject: Children with multiple disabilities

(30 July 2002)

A report from the Ministry of Education in Greece states that, for one category of children with multiple
disabilities (simultaneously suffering from psychomotor deficiencies, blindness and lack of self-sufficiency
in terms of their basic needs), there is no specific, specialised infrastructure for the rehabilitation of their
injuries and their care, so that their living conditions depend on their close relatives.

Article 13 of the Treaty establishing the European Community stipulates that ‘the Council … may take
appropriate action to combat discrimination based on sex (…), disability, age or sexual orientation’. In its
resolution on equal opportunities for people with disabilities (20/12/96, 97/C 12/01),
the Council
expressed its commitment
to ‘the principle of equality of opportunity in the development of
comprehensive policies in the field of disability’ and substantial funding has already been allocated to
measures in favour of individuals with special needs. In view of this:

1. Does the Commission intend to contribute to the establishment of a protection and care framework in
Greece which will give these individuals the opportunity to lead lives which are as dignified as possible?
What arrangements are made in the other Member States for people with disabilities of this type?

2. Within the context of the free movement of people, is it possible for these children to be admitted to
centres or institutions established in other Member States under the applicable rules, provided that their
guardians wish them to do so and they cannot be catered for in Greece?

2003 has been designated ‘European Year of Disabled People’; with this in mind, does the

3.
Commission intend to take any additional initiatives to improve the lives of children in this category?

Answer given by Mrs Diamantopoulou on behalf of the Commission

(16 September 2002)

The arrangements for treatment of individual citizens in institutions within a Member State does not fall
within the competence of the Commission and it is therefore unable to intervene in individual instances.
However, since 1984, under the Community Support Framework (CSF), financial assistance has been made
available in order to support reforms in the psychiatric care sector. Under the CSF2, projects in Greece