Opinion of the European Economic and Social Committee on the "Proposal for a Decision of the European Parliament and of the Council 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 the developing countries, undertaken by a number of Member States and Norway" (COM(2002) 474 final — 2002/0211 (COD))
Date: 2003-03-26
Institutions: European Economic and Social Committee
Subjects: AIDS, Norway, developing countries, infectious disease, member country, research and development, research programme, scientific cooperation

6.6.2003

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Official Journal of the European Union

C 133/93

Opinion of the European Economic and Social Committee on the ‘Proposal for a Decision of the
European Parliament and of the Council 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 the developing
countries, undertaken by a number of Member States and Norway’

(COM(2002) 474 final — 2002/0211 (COD))

(2003/C 133/18)

On 19 September 2002 the Council decided to consult the European Economic and Social Committee,
under Article 172(2) of the Treaty establishing the European Community, on the above-mentioned
proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing
the Committee’s work on the subject, adopted its opinion on 5 March 2003. The rapporteur was
Mr Bedossa.

At its 398th plenary session on 26 and 27 March 2003 (meeting of 26 March), the Economic and Social
Committee unanimously adopted the following opinion.

1.

Introduction

Speaking on the occasion of the launch of the European
1.1.
framework
Community’s sixth research and development
programme (RDFP)
for the four-year period starting on
1 January 2003, the primary purpose of which is to create
a genuine European research area, Commissioner Philippe
Busquin stated that the 21st century, even more than the one
that had just ended, would be the century of knowledge. But
Europe would only be able to respond to this challenge if it
organised itself effectively.

1.2.
He added that the programme was designed to establish
a true internal market in knowledge in which researchers,
knowledge and technologies circulated freely and a framework
in which national and regional governments could coordinate
their research policies and integrate their activities.

2.4.
The approach pursued within this broad policy frame-
work is global, multi-sectoral and multi-factoral. For many
years the poor countries have highlighted the excessively high
price of key pharmaceuticals and the need for such countries
to participate — at a level appropriate to them — in
programmes of this kind through the development of effective
and affordable medicinal products.

2.5.
The Member States and Associated States have jointly
agreed to develop clinical research activities targeting three
diseases — HIV/AIDS, malaria and tuberculosis (TB) — since
existing treatment protocols are cumbersome, too inflexible to
respond to needs on the ground and still very expensive.

2.5.1.

This situation is largely due to the following factors:

— the fragmentation of European clinical research;

Overall, the draft decision presented by the Com-

1.3.
mission seems to be in line with this definition.

— organisational and economic impediments to conducting

clinical trials relevant to developing countries;

2. Background

— the lack of the necessary skills and facilities in developing

countries.

2.1.
The major endemic diseases (malaria and tuberculosis)
and sexually transmitted diseases such as HIV/AIDS have
increased considerably in poor countries, particularly in Africa.

2.2.
Disease and poverty go hand in hand. Consequently,
there is an urgent need on both public health and economic
grounds to break this vicious circle.

2.3.
The problem is global and at the centre of an inter-
national political debate; for several years now there have
been repeated calls for action from all
the international
organisations.

3. The aim of the programme

3.1.
Fourteen EU Member States and Norway have agreed
to launch a major new initiative, the European and Developing
countries Clinical Trials Partnership (EDCTP), a partnership
between Europe and the developing countries, particularly
those in sub-Saharan Africa, which is designed to promote
research and development activities aimed at combating HIV/
AIDS, malaria and TB.

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3.2.
New vaccines, drugs and other products necessary for
fighting these diseases are to be developed and, where possible,
put on the market as quickly as possible.

3.3.

This will be done by:

— strengthening basic knowledge,
which is an absolute necessity;

the development of

— networking and cooperation between the participating

national programmes;

— accelerating the development of new products, including

the launch of clinical trials in the developing countries;

— strengthening capacities for research into the treatment
of these poverty-related diseases through cooperation
between the EU and the developing countries.

4.2.
The Community contribution of 200 million EUR will
have a leverage effect, enabling funding to be obtained from
other sources, either the participating states themselves or
private donors. As the Commission notes, the funding will act
as a catalyst for initiating the first clinical trials, creating the
necessary legal structure for the EDTCP and contributing
significantly to capacity building in the developing countries.

Article 169 is used as the legal basis for implementing

4.3.
the programme as it allows:

— the establishment of a common platform for the develop-

ment of clinical research;

— European research to contribute to the global fight against
the three diseases in a coherent context with the organised
participation of the developing countries;

— the adoption of a time-scale that provides for the speedy
setting up of the necessary machinery and the start of the
first clinical trials by the end of 2003.

3.4.
The EDCTP programme will also promote public-
private partnerships and the search for effective and affordable
drugs and treatments, through support for clinical trials in the
developing countries.

5. General comments

The participation of these countries is important for at

3.5.
least two reasons:

— the aim must be to mobilise them as fully as possible
because ultimately it is they who can make the choices
that best reflect their needs;

— through representation in the EDCTP’s executive struc-
tures, they can share in the running of the programme
and ensure that its strategic priorities are implemented.

Two-thirds of the approved budget has been allocated for
clinical trials. Another substantial part has been allocated for
the implementation in Africa of structures supporting this
research and necessary training of staff recruited in Africa.

4. Community funding

The EESC endorses the detailed description of the

5.1.
EDTCP programme and the targets set for it, namely:

— networking and coordination of national programmes
and activities conducted in the developing countries;

— accelerated development of new products to combat the

three diseases;

— visibility and sustainability of the EDTCP programme.

5.2.
The EESC notes the general low level of activity which
currently prevails in this field, which calls for a major new
impetus to be given to research and development efforts. In
fact:

— there are very few links between existing national pro-

grammes;

— the coherence and coordination of national research
activities have not increased as expected, despite the
decision of the Lisbon European Council in 2000;

4.1.
The development of new vaccines and drugs is very
expensive. The European Union envisages a total investment
of 200 million EUR in the first five years of the programme.
Although this is a large sum, it is necessary to demonstrate the
strength of Europe’s commitment to the programme.

— giving research efforts a new impetus hinges on the
joint execution of research programmes or parts of
programmes and would not be feasible if it were necessary
integrated projects or
to wait
networks of excellence requiring a wide range of resources
and the — sometimes difficult — coordination of efforts.

for the setting-up of

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5.3.
The EESC recognises that the Community decision to
intervene to combat the three diseases is necessary and urgent.

6. Specific comments

5.4.
Countries where the three diseases are rife are suffering
severely at all levels, including the economy where poverty is
becoming even more rampant.

5.4.1.
The clinical trails partnership between the EU and
the developing countries will make it possible to combat
poverty more effectively as the countries affected will be
provided with sufficient resources to establish specific facilities
and train the necessary personnel, for example by intensifying
the transfer of knowledge that medical personnel responsible
for conducting clinical research in Africa must acquire.

5.4.2.

The aim of this intervention is clear:

— to try to bring an end to the fragmentation of European

research;

— to contribute towards strengthening competitiveness in

research and development on the global market;

— to implement European development and cooperation

policies;

— to make national programmes more relevant by pooling

them within the EDTCP.

The EESC approves the way the programme’s funding

5.5.
is structured in line with its objectives:

— networking and coordination of European national pro-

grammes;

— support

for the strengthening of capacities in the

developing countries;

— measures to ensure the visibility and sustainability of the

programme adopted.

The EESC welcomes the fact that the following are

5.6.
expressly provided for in the programme:

The EESC notes that:

The administrative procedures will be simplified, com-
6.1.
pared with the previous RDFP (Research and Development
Framework Programme); the complexity and red tape were
such that they acted as a disincentive to many research teams

The EDTCP seems to bring with it new and positive

6.2.
ideas: more autonomy and flexibility.

6.3.
It will no longer be necessary, as was the case in the
past, for each participant in a project to submit an analytical
report on their activities. As regards its coordinating role, the
programme will become the interface between the Com-
mission and all the partners. It will be responsible for ensuring
the scientific credibility of each project or network.

Evaluation procedures will be more flexible, owing to
6.4.
the Internet. Researchers must consider it an honour rather
than a chore to evaluate an initiative like the EDTCP pro-
gramme.

6.5.
The programme is intended to be not only a bridge
between researchers/developers and developing countries but
also a tool in an ambitious and unifying initiative, guaranteeing,
among other things, the transfer of technologies that can be
used to develop solutions for the treatment and prevention of
endemic diseases (malaria and tuberculosis) and sexually
transmitted diseases in the countries concerned.

6.6.
The programme will act as a catalyst for action and
help to avoid fragmentation and duplication of human and
financial resources in Member States’ national programmes.

6.7.
It would appear that, with this programme, the Com-
mission has decided to put an end to the scattershot approach
applied during the previous RDFP; instead there will be greater
integration, more decisions on long-term cooperation and
therefore fewer ad hoc alliances.

— follow-up arrangements;

— regular evaluation of the programme’s progress;

The EESC notes that the Commission has decided to
6.8.
select only three diseases: HIV/AIDS, malaria and TB. It is true
that these are serious endemic diseases which are currently
causing great devastation, especially HIV/AIDS.

— an annual report on the framework programme, present-
ed to the European Parliament and the Council
(Article 173);

— a range of anti-fraud measures to be carried out concur-

rently with the programme.

6.9.
However, the public health situation in the sub-Saharan
regions of Africa is even more grave. The EESC would point
out that there is a need for urgent action to combat other
equally serious diseases such as childhood measles, cerebro-
spinal meningitis,
filariasis, kwashiorkor,
pernicious anaemia, etc.

trypanosomiasis,

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The EESC would stress that the most urgent aspect of
6.10.
the situation in Africa is the fact that it
is economically
impossible for these countries to obtain effective drugs and
medicines that are already available.

6.11. Moreover, the EESC takes the view that, on the basis
of these drugs, clinical research must also aim to develop new

treatment protocols that are adapted to social and economic
conditions in sub-Saharan Africa.

The EESC believes that policies for the prevention of
6.12.
these three diseases are an integral part of clinical research
in the developing countries. These policies, which require
substantial resources and skilled personnel, entail radical
measures over a very long time scale in countries where the
movement of persons is difficult for numerous reasons.

Brussels, 26 March 2003.

The President

of the European Economic and Social Committee

Roger BRIESCH