WRITTEN QUESTION E-3799/02 by Elizabeth Lynne (ELDR) to the Commission. Drug Regulatory Authorities.
Date: 2003-01-07
Institutions: European Parliament, Provisional data
Subjects: financing, market approval, marketing, medicinal product, pharmaceutical industry, pharmaceutical legislation

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.