Council Conclusions of 22 September 2003 on reinforcing the competitiveness of the European-based pharmaceutical industry
Date: 2003-09-22
Institutions: Council of the European Union
Subjects: competitiveness, pharmaceutical industry, single market

18.10.2003

EN

Official Journal of the European Union

C 250/1

I

(Information)

COUNCIL

COUNCIL CONCLUSIONS

of 22 September 2003

on reinforcing the competitiveness of the European-based pharmaceutical industry

(2003/C 250/01)

THE COUNCIL OF THE EUROPEAN UNION,

WELCOMES:

RECOGNISING that the European-based pharmaceutical industry
plays a vital role in both the industrial and health sectors, as
well as in the science base;

WELCOMES the response given by the Commission to the
report of the ‘G10 High Level Group on innovation and the
provision of medicines’ in its Communication on ‘A stronger
European-based pharmaceutical industry for the benefit of the
patient’ (1);

REAFFIRMS the need for a balance between competitiveness and
public health policies, while fully respecting the Community
and national competencies involved;

— the benchmarking exercises proposed by the Commission
on both health and competitiveness issues as a guide to
policy-making over time, and UNDERLINES in this context
that new developments, such as the enlargement of the
European Union, should be duly taken into account in
the collection of data,

— the concept behind the European Virtual

Institutes of
Health, outlined by the Commission, in order to promote
clinical, pharmacological
research,
including research on medicines with smaller markets,
through linking centres of
and clinical
research into a European network of excellence;

and pharmaceutical

fundamental

pharmaceutical

UNDERLINES the need to reinforce the competitiveness of the
its
European-based
competitors, particularly by enhancing Europe's attractiveness
as a location for innovative high tech industry and for main-
taining a high quality science base; this should be accompanied
by measures to facilitate the development of competitive
generic and non-prescription sectors in the EU;

industry

vis-à-vis

INVITES Member States to:

— actively participate in the implementation of

the key
in
actions set out in the Commission's communication,
particular
appropriate
information on legislative and non-legislative measures
that could have an impact on the pharmaceutical sector,

benchmarking,

providing

by

RECOGNISES that establishing the framework for a sustainable
improvement of
the pharmaceutical
industry requires action to be taken at both national and EU
levels;

the competitiveness of

NOTES that the industrial
landscape in the European phar-
maceutical sector is made up of complementary relations
between big and small/medium enterprises spread over all
inter-
in Europe and UNDERLINES that
the regions
relationship should be developed and enhanced;

this

HIGHLIGHTS the importance of stimulating new and more inte-
grated forms of cooperation,
including public-private part-
nerships,
in Europe among governments, academia, scientific
institutions, pharmaceutical and biotechnology companies to
improve and speed up the transfer of scientific knowledge
and the availability of innovative medicines;

(1) Document 11165/03 ECO 147 SAN 152 COMPET 38 IND 103 MI

167 RECH 119.

— consider the Commission's suggested implementing actions

for:

(a) competition concerning authorised medicines that are

neither purchased nor reimbursed by the State;

(b) the rapid launch of medicines on the market after

granting a marketing authorisation;

INVITES the Commission to:

— organise an EU-wide reflection together with all interested
Member States and stakeholders on different approaches to
pricing and reimbursement
for pharmaceutical products,
exploring the scope of more competitive and dynamic
market mechanisms, aimed at ensuring the equitable and

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Official Journal of the European Union

18.10.2003

rapid access of patients throughout the EU to medicines, in
order to improve the integration of the European market in
this field, while respecting Member States' competencies
and the differences in their health care systems, including
the assessment of the added therapeutic value,

— report regularly to the Council, on the state of competi-
tiveness of the pharmaceutical sector on the basis of the
results of the benchmarking exercises on competitiveness
and public health and of information supplied by Member
States.

COUNCIL RESOLUTION

of 22 September 2003

on investing in research for European growth and competitiveness

(2003/C 250/02)

THE COUNCIL OF THE EUROPEAN UNION,

RECALLING the conclusions of
2002
and
respectively;

Brussels

2003

the Lisbon 2000, Barcelona
European Councils, which

REAFFIRMS that investing in research and technological devel-
opment and stimulating innovation and transfer of knowledge
is essential to increasing European competitiveness and to the
strategy set by the Lisbon European Council
for Europe's
economic, social and environmental development and that
there is a particular need to stimulate and improve conditions
for more private investment for research and innovation;

— set a strategic goal for the European Union to become the

most competitive knowledge-based society by 2010,

RECOGNISES that:

— agreed that overall spending on R & D in the Union should
be increased with the aim of approaching 3 % of GDP by
2010 and that two thirds of this investment should come
from the private sector,

forthcoming R & D Action

— urged Member States to take concrete action on the basis of
the Commission's
Plan,
encouraged Member States to speed up the implementation
of the European Charter for Small Enterprises and called for
the momentum behind the European Research Area (ERA)
to be maintained and strengthened by the application of the
open method of coordination in areas such as action
pursuing the 3 % of GDP objective for RTD investment
or developing human resources in science and technology,

‘Towards

the Commission Communications
a European
‘Making ERA a reality’ (2) and ‘More
Research Area’ (1),
research for Europe: Towards 3 % of GDP’ (3), and the
Council Resolutions and Conclusions on ERA,
in particular
the Conclusions of 26 November 2002 on progress made in
the European Research Area and on
the development of
providing it with new momentum (4);

WELCOMES the Commission's Communication ‘Investing in
research: an action plan for Europe’ (5), and ENDORSES the
main message of this communication which calls for a compre-
hensive and coherent range of actions to increase investments
in research and close the gap with Europe's main competitors;

(1) Document 5643/00 RECH 2 ATO 6.
(2) Document 12214/00 RECH 95 ATO 60.
(3) Document 12044/02 RECH 146.
(4) Document 14913/02 RECH 186.
(5) Document 8860/03 RECH 75 + ADD 1.

— investment

in R & D and innovation will contribute to
stimulating growth and employment, taking into account
the Communication of the Commission to the Council and
to the European Parliament on 27 November 2002
(‘Strengthening the coordination of budgetary policies’) (6)
and the conclusions of the European Council of 20-21
March 2003, the Commission communication of 7 July
2003 (‘An initiative
investing in Trans
for growth:
European Networks and major R & D projects’) (7),
the
Council conclusions of 15 July 2003 on a European
action for growth (8) and the ongoing discussions on
these subjects,

— scientific and technological excellence and quality of
research remain basic criteria for increasing and attracting
investment in R & D and innovation,

sufficient

— fundamental research, a broad and dynamic knowledge
base,
resources,
research infrastructures and mechanisms for the efficient
transfer of technology are crucial for the sustainable devel-
opment of the knowledge based society,

high-quality

human

and

contexts,

combining financial

— broad policy mixes, adapted to the respective national and
regional
and
measures to improve framework conditions, are necessary
to stimulate private investment
taking into
account the specific needs of SMEs, in particular new inno-
vative SMEs and spin-off firms, as well as those of larger
firms,

in R & D,

incentives

(6) Document 14997/02 UEM 62.
(7) Document 11343/03 ECOFIN 216 FIN 321 ECO 153 TRANS 187

ENER 217 RECH 121.

(8) Document 11463/03 PV/CONS 43 ECOFIN 222 Annex I.