WRITTEN QUESTION E-3882/03 by Cristina Gutiérrez-Cortines (PPE-DE),Bernd Lange (PSE), Karl-Heinz Florenz (PPE-DE)and Ria Oomen-Ruijten (PPE-DE) to the Commission. Inspire initiative.
Date: 2003-12-16
Institutions: European Parliament, Provisional data
Subjects: EU policy, drafting of EU law, geography, information, proposal (EU)

27.3.2004

EN

Official Journal of the European Union

C 78 E/667

orphan medicinal products (1) provides incentives to the pharmaceutical industry to develop and authorise
medicinal products for serious, rare diseases where no satisfactory method of treatment exists. This
legislation applies equally to diseases affecting children and adults.

In 2000, following major input from the Union, the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E11: ‘Clinical
Investigation of Medicinal Products in the Paediatric Population’ was finalised and implemented in the
Union.

In 2001, the European Medicines Evaluation Agency set up the Paediatric Expert Group of the Committee
for Proprietary Medicinal Products. The Paediatric Expert Group provides advice on the study and use of
medicines for children and is developing guidance for investigators and the industry on such use.

Following a resolution of the Council of Ministers, the Commission has been developing and consulting on
proposals for a new Regulation that aims specifically to address the need for greater study and
authorisation of medicines for children. The Commissions’ proposals are currently the subject of an
extended impact assessment (EIA) that is due to report in the first quarter of 2004. Following the results of
the EIA, it will be possible to finalise the proposals for adoption by the Commission. Pending the results of
the EIA, to speed up the legislative process, the Commission has set up an informal ad-hoc working group
of the Pharmaceutical Committee (which has representation from all Member States) to advice on its
informal draft proposal. In addition, the Commission is continuing its discussions with other stakeholder
groups.

4.
An emphasis is also put on child health in Priority 1 of the Union’s 6th Framework Programme for
Research and Technological Development. This thematic priority will stimulate and sustain multi-
disciplinary basic research to exploit the full potential of genome information to underpin applications to
technological development and demonstration:
human health. The specific programme for research,
‘Integrating and strengthening the European Research Area’ (2002-2006) mentions that ‘attention will be
paid to childhood diseases and related treatments, whenever appropriate’. Some topics of the Work
Programmes of this Priority are clearly devoted to children, for instance ‘Medicines for children’, or ‘Rare
autoimmune disorders: from genes to individualised medicine’ including paediatric diseases. Even if topics
do not specifically mention children, proposals selected for funding may contain parts referring to, or
centred on, children health. It is then to be expected that the results deriving from those projects will
directly benefit children, for instance through the better understanding of disease mechanisms, and the
development of new diagnostic tools and new therapeutic agents.

As regards the public health programme, there are possibilities to fund projects on public health aspects of
pharmaceuticals. The priorities and the specific research areas are identified in the annual work plans.

(1) OJ L 18, 22.1.2000.

(2004/C 78 E/0710)

WRITTEN QUESTION E-3882/03

by Cristina Gutiérrez-Cortines (PPE-DE),
Bernd Lange (PSE), Karl-Heinz Florenz (PPE-DE)
and Ria Oomen-Ruijten (PPE-DE) to the Commission

(16 December 2003)

Subject: Inspire initiative

EU policies with spatial incidence such as Natura 2000 Network, the Framework Directive on Water and
information based on
the future policy on Soil Protection, amongst others, need wide environmental
cartography in order to be implemented.

The European Parliament urged the Commission to tackle this issue rapidly in its report on the Thematic
Strategy on Soil Protection (A5-0354/03), passed on 19 November.

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27.3.2004

In this sense we welcome the legislative initiative Inspire, to which Commissioners Solbes, Busquin and
Wallström engaged themselves in the Memorandum of Agreement of 2002 and the Work Programme of
the Commission for 2003.

The information offered by the Commission on the Internet has shown great progress towards the
fulfilment of this initiative, thanks to the contributions of public and private bodies and to the support of
the Member States and of the accession countries.

We are aware that unless there is a legal mandate, the barriers to further development in the collection of
information will not be removed, and consequently the implementation of Community policies with
spatial incidence would be significantly delayed. That is why we understand that the initiative Inspire is the
appropriate instrument.

Will the Commission adopt the legislative initiative Inspire as intended in the above instruments, and will
it keep its promise about the dates indicated in them?

Should this be the case, could the Commission brief us about progress so far on the main lines of the
future proposal?

Should this not be the case, could the Commission explain the reasons for the change of position about
the dates indicated in the Memorandum of Agreement and in the Work Programme?

Answer given by Mrs Wallström on behalf of the Commission

(5 February 2004)

The Memorandum of Understanding on Inspire signed in 2002 by the Member of the Commission
the one responsible for Economic and Financial Affairs and the one
responsible for Environment,
responsible for Research serves as a basis for the collaboration between Directorate-General
(DG)
Environment, Eurostat and the Joint Research Centre to develop the Inspire initiative. The principle
objective of Inspire is to make available harmonised sources of geographical information to support the
formulation, implementation and evaluation of Community policies.

As explained in the Memorandum of Understanding, the first phase of the initiative is to define a legal
framework providing for the co-ordination of
the collection, usage of and access to geographical
information. The Commission had, consistent with the Memorandum of Understanding, scheduled the
adoption of a legal
framework for Inspire in its 2003 work programme, which also entailed the
elaboration of an extended impact assessment.

However, due to the pressure of other legislative proposals in late 2003, the Commission was obliged to
defer its adoption of the Inspire initiative. Furthermore, the extended impact assessment had highlighted
issues
its
surrounding the level of ambition of
implementation, which required some further reflexion.

Inspire and the potential

investment needs

for

The Commission has, therefore, carried forward the Inspire proposal to the Commission’s 2004 work
programme. Inspire remains an independent initiative but ensures that synergies can be developed with
other related actions in the spirit of a complementary approach. The issues raised in the impact assesment
report on investment needs will be addressed by ensuring that the scope of Inspire is targeted on the key
requirements of a Community initiative and by revising the analysis of the impacts accordingly.

Strengthened by the support
for Inspire expressed by many stakeholders, the Commission remains
committed and is determined to finalise the legal proposal on Inspire for adoption during the second
quarter of 2004, as a first step toward the creation of a multi-sectoral framework for handling and
accessing information with a spatial dimension based on a common geographical framework.