Decision No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003 on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries, undertaken by several Member States
Date: 2003-06-16
Institutions: Council of the European Union, European Parliament
Subjects: AIDS, EU Member State, EU programme, developing countries, infectious disease, research and development, scientific cooperation

8.7.2003

EN

Official Journal of the European Union

L 169/1

I

(Acts whose publication is obligatory)

DECISION No 1209/2003/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 June 2003

on Community participation in a research and development programme aimed at developing new
clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partner-
ship between Europe and developing countries, undertaken by several Member States

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Articles 169 and 172, second para-
graph, thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

Decision No 1513/2002/EC of the European Parliament
and of the Council of 27 June 2002 concerning the sixth
framework programme of the European Community for
research, technological development and demonstration
activities, contributing to the creation of the European
Research Area and to innovation (2002 to 2006) (4)
sixth framework
(hereinafter
programme’) provides for Community participation in
research and development programmes undertaken
jointly by several Member States, including participation
in the structures created for the execution of
those
programmes, within the meaning of Article 169 of the
Treaty.

referred

to as

‘the

(4)

(5)

On 30 May 2001, the Commission presented a commu-
nication on the application of Article 169 of the Treaty
and the networking of national programmes.

The Council, in its Resolutions of 10 November 2000
and 14 May 2001, and the European Parliament, in its
Resolution of 4 October 2001 (5), underlined the gravity
of the HIV/AIDS, malaria and tuberculosis epidemics and
the need to step up efforts to increase aid at national,

(6)

(1)

(2)

(3)

regional and world level, and endorsed the Programme
for Action: accelerated action on HIV/AIDS, malaria and
tuberculosis in the context of poverty reduction.

In its conclusions of 30 October 2001, the Council
called on Member States to select specific areas for pilot
programmes,
for which Community participation in
research and development programmes undertaken at
several Member States within the
the initiative of
meaning of Article 169 of the Treaty would be appro-
priate,
if necessary in close collaboration with the
Commission.

In connection with its communications to the European
Parliament and the Council of 20 September 2000 and
21 February 2001 the Commission has presented an
action programme aimed at combating the global
problem of HIV/AIDS, malaria and tuberculosis and
identifying various strategies to be implemented. This
action programme has various closely linked and inter-
dependent parts: promoting prevention, encouraging
treatment and making essential medicinal products more
affordable and stepping up research and development.
The research and development part is aimed, among
in coordination with the
other things, at developing,
application of this decision, new clinical interventions to
combat the three diseases through a long-term partner-
ship between Europe and developing countries. In the
interventions
design of clinical trials for new clinical
against HIV/AIDS, malaria and tuberculosis, coexisting
infections should be taken into account.

In their Decision No 36/2002/EC (6),
the European
Parliament and the Council decided that the Community
would contribute EUR 60 million for the year 2001 to
tuberculosis and
the global
malaria. As the Global Fund does not finance research
and development activities, additional funds for research
and development are required.

fund to fight HIV/AIDS,

(1) Proposal of 29 August 2002 (not yet published in the Official

Journal).

(2) OJ C 133, 6.6.2003, p. 93.
(3) Opinion of the European Parliament of 27 March 2003 (not yet
published in the Official Journal) and Decision of the Council of 13
May 2003.

(4) OJ L 232, 29.8.2002, p. 1.
(5) OJ C 87 E, 11.4.2002, p. 244.

(6) OJ L 7, 11.1.2002, p. 1.

L 169/2

EN

Official Journal of the European Union

8.7.2003

Member States are undertaking individual research and
development programmes or activities aimed at devel-
oping new clinical
interventions to combat the global
problem of HIV/AIDS, malaria and tuberculosis. These
programmes or activities, the required funds for which
have been granted, form part of long-term partnerships
with developing countries.

pation of the private sector and mobilising additional
funds to fight these diseases, including funds from the
private sector. Because of the nature of the Programme,
a significant part of the funding would be spent in the
developing countries.

(7)

(8)

At present, the research and development programmes
or activities undertaken individually at national level are
not sufficiently coordinated at European level and do not
for an
allow a coherent approach at European level
effective
development
and
programme to combat HIV/AIDS, malaria and tubercu-
losis in the developing countries or make it possible to
find optimal treatments suited to conditions in the devel-
oping countries.

technological

research

Ireland,

France, Germany, Greece,

(9) Wishing to have a coherent approach at European level
and to act effectively against HIV/AIDS, malaria and
tuberculosis in developing countries, Austria, Belgium,
Denmark,
Italy,
Luxembourg, the Netherlands, Portugal, Spain, Sweden
and the United Kingdom (hereinafter referred to as ‘the
participating Member States’) and Norway have taken
the initiative, with developing countries, for setting up a
research and development programme entitled ‘The
European and Developing countries Clinical Trials Part-
EDCTP
referred
nership’
Programme) in order to obtain a critical mass in terms
of human and financial resources and the combination
of additional expertise and resources available in various
countries across Europe and the developing countries.

(hereinafter

the

to

as

(10)

(11)

its

for

In the spirit of the sixth framework programme, the
Community should have the right to agree the condi-
tions
financial contribution to the EDCTP
Programme in relation to the participation therein of
other countries, in the course of its implementation, in
accordance with the rules and conditions set out in this
Decision.

The objective of the EDCTP Programme, for the total
cost of which a target figure is estimated at EUR 600
million over a five-year period, is to accelerate the devel-
opment of new clinical interventions to fight HIV/AIDS,
malaria and tuberculosis in the developing countries,
particularly in sub-Saharan Africa, and to improve
generally the quality of research in relation to these
diseases. The EDCTP Programme has been drawn up
with a view to stepping up cooperation and the
networking of European national programmes, acceler-
ating clinical trials of new products, in particular drugs
and vaccines,
in the developing countries, helping to
develop and strengthen capacities in the developing
technology
including the promotion of
countries,
transfer where appropriate and encouraging the partici-

(12) A similar initiative could be launched at a later stage,
including other neglected diseases which particularly
affect poor people in the developing countries, provided
that
such
programmes and that the Framework Programme has a
corresponding research priority.

implementing

the Member

States

are

(13)

The participating Member States have agreed to coordi-
nate and implement jointly activities aimed at contri-
buting to the EDCTP Programme for a proposed period
of five years. The overall value of their national partici-
pation is estimated at EUR 200 million.

(14) Activities linked to obtaining additional funds, whether
public or private, estimated at EUR 200 million, are
provided for
the EDCTP
in the implementation of
Programme.

(15)

(16)

(17)

to increase

In order
the EDCTP
the
Programme, the Community should participate therein
by making a financial contribution of up to EUR 200
million.

impact of

the

impact of

to increase

the EDCTP
In order
Programme,
the Community should aim at synergy
effects with related Community initiatives in the field of
improving public health in the developing countries,
with a view to the latter enhancing their clinical, regula-
tory and community capacities necessary to play effec-
tively their role in the EDCTP partnership.

The participating Member States have agreed on a model
of governance involving a Partnership Board, and a
common structure to implement the EDCTP Programme.
The Partnership Board will ensure a balanced participa-
tion of experts from the participating European States
and from the developing countries involved in the
EDCTP Programme and will define, develop and plan the
strategy of
the Programme to be approved by the
common structure. The common structure is a legal
entity which will guarantee the Community dimension
in implementing the EDCTP Programme and will be the
recipient of the Community financial contribution.

(18) Given that the EDCTP Programme meets the scientific
objectives of the sixth framework programme and that
the research field of the EDCTP Programme falls within
the priority theme ‘Life sciences, genomics and biotech-
nology for health’ of the sixth framework programme,
the Community financial contribution should be taken
from the budget appropriation allocated to that priority
theme.

8.7.2003

EN

Official Journal of the European Union

L 169/3

(19)

(20)

that

is essential

the research activities carried out
It
under the EDCTP Programme conform to basic ethical
principles, including those reflected in Article 6 of the
Treaty on European Union and in the Charter of Funda-
mental Rights of the European Union, and apply the best
clinical practices and follow the principles of gender
mainstreaming and gender equality.

It is also essential that research activities carried out
under the EDCTP Programme meet the needs of devel-
oping countries and are coherent with the global
European Union policy for
improving health and
combating poverty-related diseases in developing coun-
tries,

HAVE ADOPTED THIS DECISION:

Article 1

1.
In implementing the sixth framework programme of the
European Community for research, technological development
and demonstration activities, contributing to the creation of the
European Research Area and to innovation (2002 to 2006)
(hereinafter referred to as ‘the sixth framework programme’),
adopted by Decision No 1513/2002/EC, the Community shall
make a financial contribution to the research and development
programme entitled ‘The European and Developing countries
Clinical Trials Partnership’ (hereinafter referred to as ‘the EDCTP
Programme’) undertaken jointly by several Member States (here-
inafter referred to as ‘the participating Member States’).

2.
The Community shall pay a financial contribution to the
common structure amounting to a maximum of EUR 200
million for the duration of the sixth framework programme.

3.
The Community financial contribution shall be paid from
the budget appropriation allocated to the priority theme ‘Life
sciences, genomics and biotechnology for health’ of the specific
programme of the sixth framework programme entitled ‘Inte-
grating and strengthening the European Research Area (2002
to 2006)’.

Article 2

The Community financial contribution shall be conditional
upon:

(a) the carrying out of

the activities under

the EDCTP

Programme described in Annex I to this Decision; and

(b) the implementation and coordination of the research and
development programmes and activities undertaken at
national level by the participating Member States;

and also upon:

(c) the establishment by the participating Member States, or
organisations designated by participating Member States, of
a structure with legal personality (for the purposes of this
Decision referred to as ‘common structure’), which shall be
responsible
EDCTP
Programme and for receiving, allocating and monitoring
the Community financial contribution;

implementation of

the

the

for

(d) the establishment of the governance model for the EDCTP
Programme in conformity with the guidelines set out in
Annex II to this Decision;

(e) ensuring a high level of involvement of developing coun-

tries;

(f) ensuring a high level of scientific excellence and observance
of ethical principles in accordance with the general princi-
ples of the sixth framework programme; and

(g) formulation of the provisions relating to intellectual prop-
erty rights in such a way that they also aim at ensuring that
the people of developing countries have easy and affordable
access to the research results produced by activities under
the EDCTP Programme and to the products directly
deriving from its results.

Article 3

The arrangements for the Community financial contribution
and the rules relating to financial liability and to intellectual
property rights shall be adopted jointly by means of an agree-
to be concluded between the Commission and the
ment
common structure, in accordance with the Financial Regulation
applicable to the general budget of the European Communities.

Article 4

The Commission and the Court of Auditors may, through their
officials or agents, carry out all the checks and inspections
needed to ensure proper management of the Community funds
and protect the financial interests of the Community against
any fraud or irregularity. To this end, the participating Member
States and/or the common structure shall make all relevant
documents available to the Commission and the Court of Audi-
tors.

Article 5

The Commission shall communicate all relevant information to
the European Parliament, the Council and the Court of Audi-
tors. The participating Member States are invited to forward,
through the common structure, to the Commission any addi-
information required by the European Parliament, the
tional
Council and the Court of Auditors concerning the financial
management of the common structure.

Article 6

This Decision shall apply to Member States
common structure.

joining the

Article 7

The conditions for the Community financial contribution in
relation to the participation, in the EDCTP Programme, of any
country associated with the sixth framework programme or,
where essential for implementing the EDCTP programme, of
any other country, may be agreed by the Community on the
basis of the rules set out in this Decision and of any imple-
menting rules and arrangements.

L 169/4

EN

Official Journal of the European Union

8.7.2003

Article 8

Article 9

The annual
report on the sixth framework programme
presented to the European Parliament and the Council pursuant
to Article 173 of the Treaty shall include a summary of the
activities of the EDCTP Programme undertaken. This summary
shall also be part of the regular progress report on the Commu-
nity Programme for Action: accelerated action on HIV/AIDS,
malaria and tuberculosis in the context of poverty reduction.

the end of

the five-year period,

the Commission shall
At
conduct an evaluation of the EDCTP Programme. Results of this
evaluation shall be presented to the European Parliament and
the Council.

This Decision is addressed to the Member States.

Done at Luxembourg, 16 June 2003.

For the European Parliament

The President

P. COX

For the Council

The President

G. PAPANDREOU

8.7.2003

EN

Official Journal of the European Union

L 169/5

ANNEX I

Description of the activities of the EDCTP Programme financially supported by the Community

In cooperation with developing countries, the participating Member States have set up the EDCTP Programme.

There are several types of activities under the EDCTP Programme to which the Community makes a financial contribu-
tion in accordance with the procedures to be laid down in the agreement between the Commission and the common
structure:

1. Activities linked to networking and coordination of:

(a) European national programmes;
(b) the activities carried out in the developing countries.

These activities are aimed at strengthening the two main components of the EDCTP Programme: programmes/activ-
ities in Europe on the one hand and in the developing countries on the other.

2. RTD activities linked directly to the development of new products and the improvement of existing products against
the three diseases (HIV/AIDS, malaria and tuberculosis), suited to the specific requirements of the developing coun-
tries, i.e. that they are effective, easy to use and as affordable as possible:
(a) support for clinical trials in the developing countries, taking into account, in the design of the trials, coexisting

infections and giving due consideration to sexual and reproductive health;

(b) strengthening of capacities in the developing countries.

3. Activities planned to ensure the development, visibility and sustainability of the EDCTP Programme:

(a) activities to promote the EDCTP Programme to ensure a high profile at European or international level;
(b) activities linked to obtaining the necessary funds, including those from the private sector, to enable the EDCTP

Programme to develop as planned, including beyond the period covered by this Decision;

(c) regular reporting on the implementation of the EDCTP Programme with special emphasis on its public-interest

value.

4. Basic activities for the EDCTP Programme such as secretariat services and the management of information concerning

clinical interventions against the three diseases (HIV/AIDS, malaria and tuberculosis).

ANNEX II

Guidelines for the model of governance of the EDCTP Programme

This model should comprise the following:

1. A ‘Partnership Board’ which should define, develop and plan the implementation of strategy to be approved by the
common structure. The Board should include a balanced contingent of experts from the participating European States
and from the developing countries involved in the programme. It should also include representatives of the Commis-
sion and experts from the public or private structures involved in the programme and from other international
programmes/organisations, such as the WHO, where appropriate.

2. The ‘common structure’, set out as a European Economic Interest Grouping (EEIG) as established by Council Regula-
tion (EEC) No 2137/85 (1). The EDCTP EEIG will be the executive structure and manage the programme through its
secretariat. It will comprise two main bodies:
(a) the ‘EEIG Assembly’, which should be the highest authority within the EEIG; and
(b) the ‘EEIG Secretariat’, which should provide administrative support for the work of the Partnership Board and the

EEIG Assembly.

(1) OJ L 199, 31.10.1985, p. 1.