WRITTEN QUESTION P-3796/02 by Dirk Sterckx (ELDR) to the Commission. Places of refuge for vessels in distress.
Date: 2002-12-17
Institutions: European Parliament, Provisional data
Subjects: harbour installation, indemnification, maritime safety, pollution control measures, pollution from ships, prevention of pollution, transport accident

3.7.2003

EN

Official Journal of the European Union

C 155 E/189

Answer given by Mrs Diamantopoulou on behalf of the Commission

(7 February 2003)

The infringement proceedings (1) against Portugal to which the Honourable Member refers are concerned
law of Council Directive 98/59/EC of 20 July 1998 on the
with the transposition into national
approximation of the laws of the Member States relating to collective redundancies.

More specifically, the Commission is rebuking Portugal for its failure to meet its obligations under the EC
Treaty, and under Articles 1, 6 and 7 of the above-mentioned Directive, in that the relevant Portuguese
legislation restricts the concept of collective redundancies to dismissals for structural, technological or
economic reasons. In the Commission’s view, this concept is defined more broadly in Directive 98/59/EC,
which applies to dismissals effected by an employer for one or more reasons not related to the individual
workers concerned. A consequence of the concept of collective redundancies being restricted under
Portuguese law is that the protection of workers which the Directive aims to provide does not extend, for
example, to instances of bankruptcy, expropriation or fire, or to cases where a firm ceases to operate
following the death of the entrepreneur.

(1) Case C-55/02, currently pending before the Court of Justice.

(2003/C 155 E/209)

WRITTEN QUESTION P-3796/02

by Dirk Sterckx (ELDR) to the Commission

(17 December 2002)

Subject: Places of refuge for vessels in distress

When Directive 2002/59/EC (1) establishing a Community vessel traffic monitoring and information system
was being discussed, I advocated a stricter regime for ports and other places of refuge for vessels in distress
and called for compensation arrangements for ports accommodating vessels in distress. It might perhaps
have been possible to prevent the ‘Prestige’ disaster if the damaged vessel had been taken to a port or other
place of refuge or mooring instead of out to sea.

Directive 2002/59/EC lays down that ports should be able to rely on prompt compensation for any costs
and damage involved in such operations. The Commission was to examine whether a system of
compensation can be introduced and whether it is feasible to require vessels putting in at a European port
to be adequately insured.

Has the Commission now examined the scope for this? Does it not consider that, in the light of the
‘Prestige’ disaster, the regime for ports of refuge must urgently be tightened up further?

(1) OJ L 208, 5.8.2002, p. 10.

Answer given by Mrs de Palacio on behalf of the Commission

(24 January 2003)

The only obligations laid down by international law to date are for information and cooperation between
national authorities to assist vessels in distress. There is as yet no obligation to accommodate such vessels.

As the Honourable Member points out, following the Erika disaster the Commission did propose new rules
on places of refuge. Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002
establishing a Community vessel traffic monitoring and information system (part of the Erika II package) (1)
stipulated that all Member States should develop plans to deal with this type of situation and must inform
the Commission of
‘Such plans shall contain the necessary arrangements and
procedures (…) to ensure that ships in distress may immediately go to a place of refuge subject to
authorisation by the competent authority.’ The Directive, adopted in summer 2002, is to be incorporated
into national legislation by February 2004.

It stipulates,

them.

C 155 E/190

Official Journal of the European Union

EN

3.7.2003

The Prestige accident highlights once again the importance of a firm commitment from the Member States
to apply the Erika package ahead of time, without waiting for the official deadlines, according to the
undertakings they gave at
in its
communication of 3 December 2002 (2), the Commission called upon the competent authorities to speed
up the preparations of the plans to accommodate vessels in distress in places of refuge.

the Nice European Council

in December 2002. That

is why,

To further this task, and to promote coordination between Member State measures, a meeting will be held
on the subject on 31 January 2003, which will examine the practical aspects of implementing the
provisions on places of refuge. The Commission will then monitor the relevant measures, in cooperation
with the European Maritime Safety Agency.

The Commission considers that the possibility of co-financing raised by the Honourable Member would
best be addressed in the course of the preparatory work on the forthcoming revision of the trans-European
networks and, specifically, within the ‘Van Miert Group’, which the Commission has created, made up of
representatives of the Member States and candidate countries.

(1) OJ L 208, 5.8.2002.
(2) COM(2002) 681 final.

(2003/C 155 E/210)

WRITTEN QUESTION E-3799/02

by Elizabeth Lynne (ELDR) to the Commission

(7 January 2003)

Subject: Drug Regulatory Authorities

At present, drug firms pay the Drug Regulatory Authorities (DRA)
I understand that
pharmaceutical firms, thanks to the European harmonisation of pharmaceutical regulation, can choose
which DRA they want to approach. They do not have to negotiate with separate national regulatory
regimes. Drugs can be marketed in several states simultaneously taking advantage of these fast approval
rates.

for licences.

What is the Commission’s stance regarding the funding of DRAs?

Does the Commission believe that companies should have to negotiate separately with each national
regulatory authority in order to be able to market their drugs?

Answer given by Mr Liikanen on behalf of the Commission

(12 February 2003)

The funding of the Drug Regulatory Agencies (DRA) in the Member States lies within the competence of
each Member State.

Member States have different systems concerning the funding of the DRA: some systems are based on the
in-come by granting marketing authorisations, including variations, renewals and annual fees, others DRA
are funded by the government. In most of the Member States a mixed funding exists.

Pharmaceutical companies can choose, in the frame of mutual recognition procedure, in which of the
Member States they want to place the medicinal product on the market. Each competent authority of the
Member States concerned by this procedure will give a national marketing authorisation.

Pharmaceutical companies have to pay for each marketing authorisation given by the competent
authorities of the Member States to place a medicinal product on the market. Concerning this particular
issue, the Commission does not take any position; it is considered as the payment of a service to the
economic operator. Information about the level of fees that each Member State is requesting for granting a
marketing authorisation for a medicinal product can be found on the web-sites of the relevant authorities
of Member States.