Council Resolution of 2 December 2003 on pharmaceuticals and public Health challenges — focusing on the patients
Date: 2003-12-02
Institutions: Council of the European Union
Subjects: consumer protection, exchange of information, health policy, medicinal product, public health

C 20/2

EN

Official Journal of the European Union

24.1.2004

5. ENDORSES:

— the various initiatives announced in the Communication
in order to increase transparency and trust in relation to
the placing on the market and putting into use of
medical devices;

intended

— the working programmes attached to the Communi-
as
improve
cation
presented by the Commission, in particular in relation
to market
clinical
evaluation, and regulatory clarification;

surveillance, Notified

implementation,

Bodies,

to

— the Commission's intention to carry out within 5 years a
the working programmes

the impact of

review of
announced in the Communication;

6.

to actively engage in the
INVITES the Member States
reporting of
information as requested by the Directive
93/42/EEC on medical devices in relation to the consul-

tation mechanisms foreseen in those cases where medical
contain medicinal products or human blood
devices
derivatives, clinical
investigation and vigilance, allowing
complete and consistent data to be made available for
analysis in conformity with the provisions of the Directive;

7.

INVITES THE COMMISSION AND THE MEMBER STATES:

— to set up and maintain the European Database for
Medical Devices and, as a basis for the database, to
start
the Global Medical Devices
Nomenclature;

implementation of

— to strengthen coordination between the Commission
and the national authorities in charge of implementing
to ensure a consistent and
the directives
the
coherent
directives and to achieve greater efficiency in the
interest of protecting public health.

interpretation and implementation of

in order

COUNCIL RESOLUTION

of 2 December 2003

on pharmaceuticals and public Health challenges — focusing on the patients

(2004/C 20/02)

THE COUNCIL OF THE EUROPEAN UNION

1. RECALLS the Council Conclusions on Medicinal Products
and Public Health of 29 June 2000 (1), which stress the
need for greater actions in the area of added therapeutic
value,
rational use of medicines and information to
patients;

2. CONSIDERS that the 14 recommendations of the ‘G10 High
Level Group on innovation and provision of medicines’,
contained in its Report of March 2002, are designed to
contribute to both industrial competitiveness and public
health goals and HIGHLIGHTS in particular the recommen-
dations that call for better information to patients and the
systems for pharmacovigilance and
need for stronger
relative effectiveness within Member States;

3. WELCOMES the Commission communication entitled ‘A
stronger European based pharmaceutical Industry for the
benefit of the patient’ in response to the above-mentioned
14 recommendations of the G10 Medicines Group and

TAKES NOTE of the ‘G10 Medicines Conference’, held in
Rome on 10 and 11 July 2003;

4. RECALLS the Council Conclusions of 22 September 2003
on ‘Reinforcing the competitiveness of the European-based
industry’ (2); REAFFIRMS the need for a
pharmaceutical
and public health
balance between competitiveness
policies; and RECOGNISES the contribution and importance
of a strong and competitive pharmaceutical
industry in
Europe to the improvement of public health;

5. RECALLS the common positions on the review of

the
Community legislation on pharmaceuticals adopted by
the Council on 29 September 2003, and the importance
of the review for achieving some of the goals set out in the
G10 recommendations;

6. STRESSES the importance of monitoring the impact of EU
enlargement for the health systems in the Member States
and Acceding States, especially due to free movement of
the
people and products, and NOTES in this context
Declaration of the Ministers of Health of the Acceding
Countries signed in Milan on 5 September 2003;

(1) OJ C 218, 31.7.2000, p. 10.

(2) OJ C 250, 18.10.2003, p. 1.

24.1.2004

EN

Official Journal of the European Union

C 20/3

7. UNDERLINES that the patients must be the focus of phar-
maceutical policies and that, therefore, emphasis should, in
particular, be on:

a) providing medicines needed to treat otherwise incurable
diseases as well as more efficacious, safer and higher
quality medicines;

States,

12. CALLS on the Commission and the Member States to
co-operate in the development of an EU system of
sharing available data on medicines marketed in the
to
Member
level.
harmonise the collection of key data at national
This should involve the national medicines agencies and
be undertaken in collaboration with the EMEA as a
possible focal point for such a system, and should be
integrated with its on-going telematics work;

exploration of ways

including

b) ensuring better and more accessible information to
to promote the rational use of

in order

patients,
medicines;

c) reinforcing the systems for pharmacovigilance within

Member States;

d) ensuring availability and affordability of medicines to
all patients, thereby respecting the competencies of the
Member States;

13. WELCOMES the EU telematic strategy to underpin the regu-
latory process with more effective use of existing IT
resources and ENCOURAGES the Commission and the
through the EMEA and the National
Member States,
Medicines Agencies,
as
strategy
quickly as possible and,
to establish the
EuroPharm database to improve the quality and availability
of product
information on all medicines available in
Europe;

to implement

in particular,

this

8. RECOGNISES that in order to respond to the public health
challenges, action is required at both national and EU level
while
and Community
competencies; and AGREES that the objectives outlined in
this Resolution shall be achieved by making the best
possible use of available resources and means;

fully respecting the national

14. ENCOURAGES the Member States to reflect on ways to
improve the assessment of relative effectiveness in their
decision making on the reimbursement of medicines in
the interest of creating greater certainty and reliability
for stakeholders. Any such decision will have to be
carried out within the
the different
national health care systems;

framework of

9. HIGHLIGHTS the increasing expenditure on medicines,
whilst recognising Member States' competence to manage
expenditure on health care
including on
in accordance with national priorities and
medicines,
inter alia by promoting rational
public spending limits,
use of medicines and the use of generics;

systems,

10. SUPPORTS the development of greater coherence between
public health needs and research activities at European
level, and STRESSES that
the concept of European
Virtual Institutes of Health should be explored further in
this regard as a way of co-ordinating research, while
considering existing and
noting the
proposed European structures to prevent and control
diseases;

importance of

11.

INVITES the Commission and the Member States
promote scientific and technological research on:

to

— medicines for diseases that otherwise cannot be treated
effectively by developing new and more effective
policies to facilitate the co-operation of public and
private
other
research institutions as well as to better bridge basic
and applied research, and

organisations with

academia

and

— medicines needed for treating diseases of developing

countries, particularly in Africa;

15. WELCOMES the Commission's project

to facilitate an
exchange of
information in the area of relative effec-
tiveness between Member States, and CALLS upon the
Commission to develop mechanisms for Member States
to generate and share this information while recognising
that the issue of relative effectiveness must remain separate
from the authorisation process. This exercise should be
supported by better and more available comparative data;

16. CALLS on the Commission and the Member States to work
collaboratively to strengthen the collection and dissemi-
nation of data that can enable the evaluation of methods
for establishing the cost effectiveness of medicines, as well
as of their effectiveness in relation to other treatments in
In particular, consideration should be given to
Europe.
ways
information to health
professionals and to patients;

to communicate

this

17.

through the

relevant national

INVITES the Commission to explore with the Member
States,
and European
competent authorities, the possibility of setting up of a
European Medicines Information System for patients and
health professionals with the objective of providing
information on medicines and related conditions, that is
of high quality, objective,
transparent, comprehensive,
reliable and up-to-date. This could involve:

C 20/4

EN

Official Journal of the European Union

24.1.2004

— extracting and using existing information within the
Member States from national medicines agencies, and
suppliers such as patient groups or professional bodies;

the development of policy at European level. This is
important as the needs of patients are the focus of phar-
maceutical policies both at Community and national level;

— consideration of ways to tailor this information to
such as health professionals,

specific
patients and the general public; and

audiences,

— making use of existing initiatives such as the develop-

ment of a European Health Portal;

18. WELCOMES the Commission's initiatives to explore the
feasibility of actions to evaluate the quality of existing
non promotional
information provided to patients and
to ensure quality in the provision of non promotional
information to the public through internet sites. The
Commission should ensure that
this builds on existing
European initiatives in e-health, such as the development
of quality criteria for internet websites;

19. CALLS for support of

the work and participation of
patients'groups in order to ensure that patients' needs in
the pharmaceutical sector are duly taken into account in

20.

INVITES the Commission to ensure in its proposed bench-
marking exercise a balance between industrial, public
health and social policies. To this end consideration
should also be given to the role of industry, governments,
health professionals and users of medicines when assessing
the performance of the pharmaceutical sector;

21. CALLS on the Commission, the Member States and the
to continue to
EMEA, each within their competencies,
develop and speed up decision-making procedures
to
make possible the immediate use of new medicines that
are of major public health importance, such as life-saving
medicines and medicines for illnesses for which there is a
high probability of short term lethal outcome;

22. CALLS on the Commission to come forward with a set of
incentives,
supporting
regulatory measures and other
measures to encourage the development and marketing
of paediatric medicines.