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
Date: 2002-08-28
Institutions: European Commission
Subjects: EU financing, EU programme, cooperation policy, developing countries, infectious disease, research and development, testing, therapeutics

EN

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 28.8.2002
COM(2002) 474 final

2002/0211 (COD)

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

(presented by the Commission)

EXPLANATORY MEMORANDUM

The global crisis:

Communicable diseases not only cause considerable poverty but are also the consequence of
poverty in developing countries, particularly in Sub-Saharan Africa. HIV/AIDS, malaria and
tuberculosis (TB) alone cause more than 5 million deaths every year, with 95% of these in the
developing world. Since poverty itself contributes to the spread of these diseases, this vicious
circle of disease and poverty causes a fundamental public health and economic crisis.

This crisis requires a dramatic solution that is beyond the resources of individual governments
and is at the centre of the international political debate with calls for urgent action (EC Round
table  2000,  G8  Communication  of  Okinawa  2000,  UNGASS  2001).  In  response  to  this
emergency, the Commission has launched its Programme for Action : Accelerated  action  on
HIV/AIDS,  malaria  and  TB  in  the  context  of  poverty  reduction.  The  Council  and  the
Parliament emphasised the gravity of the HIV/AIDS, malaria and TB epidemics and the need
to  increase  support  at  national,  regional  and  global  levels  in  their  response  to  the  policy
framework  and  the  Programme  for  Action  presented  by  the  Commission  in  2000  and  2001
(Resolutions of 10 November 2000, 14 May and 4 October 2001).

This  Programme  for  Action  creates  a  broad  policy  framework  for  a  comprehensive,  global,
multi-sectoral approach to poverty-related diseases based on improving the impact of existing
interventions, increasing affordability of key pharmaceuticals, and developing new and more
effective health products. In this context the Commission has proposed to establish a clinical
trials programme responding to the needs of Developing countries. The goal is to accelerate
the  development  of  new  clinical  interventions  to  fight  HIV/AIDS,  malaria  and  TB  in  the
Developing countries.

Current situation:

Member  States  and  Associated  States  will  invest  more  than €  1  billion  for  the  years  2002-
2007 in basic and clinical research to develop new clinical interventions against HIV/AIDS,
malaria  and  TB.  However,  although  vast  quantities  of  relevant  research  results  are  being
generated, they are failing to be translated into health improvement tools that are applicable in
the  Developing  countries.  The  decreased  efficiency  and  impact  of  the  individual  states’
investments is caused by :

1)

2)

3)

lack  of  adequate  networking  and  co-ordination  between  the  European  national
programmes resulting in fragmentation of European research in this field;

major  organisational  and  economic  impediments  to  conduct  clinical  trials  of
sufficient size and ambition to achieve meaningful results;

insufficient  involvement  of  the  Developing  countries  where  the  target  diseases  are
endemic, often due to lack of adequate clinical research facilities and trained human
resources.

The European and Developing countries Clinical Trials Partnership

14 EU Member States and Norway have recognised that a political commitment is required to
overcome  these  problems.  In  order  to  exploit  Europe’s  investment  to  confront  HIV/AIDS,
malaria  and  TB  in  the  Developing  countries,  and  mobilised  and  supported  by  the  European

2

Commission,  they  are  creating  the  “European  and  Developing  countries  Clinical  Trials
Partnership (EDCTP)”  as  a  flagship  initiative  to  accelerate  the  development  of  new  clinical
interventions to fight these diseases, particularly in Sub-Saharan Africa.

The  EDCTP  is  unprecedented  in  scope  and  ambition  and  unites  practically  all  the  relevant
clinical research and development activities undertaken by 14 EU Member States and Norway
together with that of the Community. The EDCTP will also provide an urgently needed “pull”
to encourage and accelerate more basic research and pre-clinical research in this field.

The  overall  goal  of  the  EDCTP  is  to  accelerate  the  development  and  evaluation  of  new
vaccines, drugs and other preventive or therapeutic tools against HIV/AIDS, malaria and TB
in full partnership between Europe and the Developing countries. Research activities carried
out within the framework of the EDCTP will respect fundamental ethical principles, including
those which are reflected in Article 6 of the Treaty of the European Union and in the Charter
of Fundamental Rights of the European Union.

This new partnership builds on a joint programme of clinical research activities in Europe and
in the Developing countries. The EDCTP has the following three major objectives, which are
coherent with EU-research, trade and development policies:

1)

2)

3)

Networking  and  co-operation  between  the  participating  national  programmes  to
increase  their  efficiency  and  impact  and  overcome  the  fragmentation  of  European
research in this field. The most powerful means of networking research programmes
is  by  the  joint  implementation  of  programmes  or  large  parts  of  programmes.  This
will contribute to realising the principles of the European Research Area in this field
of research.

Acceleration of the development of new products by supporting clinical trials in the
Developing  countries,  thus  promoting  transfer  of  research  into  clinical  practice
thereby strengthening Europe’s R & D excellence on the global market.

Strengthening  clinical  research  capacities  in  the  Developing  countries  in  the  fight
against the three poverty-related diseases, in line with European development and co-
operation objectives. This aim would also help establish a long term sustainable and
genuine partnership between Europe and the Developing countries.

The EDCTP  joint  programme  will  link  and  provide  a  range  of  services  designed  to  support
the networking and co-operation of national programmes, support for clinical trials from the
public and private sectors, particularly the establishment of new public-private partnerships to
help  advance  new  affordable  and  effective  medical  products  through  clinical  trials,  and  to
strengthen the logistic, clinical and laboratory research capacities in Developing countries to
conduct clinical trials including training schemes and support to local ethical review systems.

A  robust  and  dynamic  legal  entity  is  needed  for  the EDCTP  to  be  able  to  respond  to  the
challenges in a flexible manner. A European Economic Interest Grouping is seen as a suitable
legal structure for the  EDCTP joint programme, as it specifically allows the creation of new
activities based on those of its members.

The participating countries recognise that the EDCTP cannot achieve its goal without genuine
participation  of  the  Developing  countries.  The  development  of  new  health  products  should
meet  the  needs  of  the  Developing  countries  and  be  determined  by  them.  Without  active
programmes to strengthen and develop capacity in the Developing countries, those countries

3

will  not  be  able  to  play  the  critical  role  expected  of  them  in  the  partnership.  Therefore,
Developing  countries  share  ownership  of  this  initiative  by  fully  participating  in  the
development and implementation of the EDCTP strategic priorities through representation in
the  EDCTP  executive  structures.  In  addition  the  EDCTP  encourages  the  participation  of
WHO and other public or private organisations in the EDCTP’s programme.

Community funding of the EDCTP

The  report  on  Macroeconomics  and  Health  commissioned  by  WHO  states  a  need  for  3
billions  of  Dollars  per  year  for  additional  investments  in  biomedical  and  health  research  to
successfully  confront  the  three  diseases  through  the  development  of  new  efficient
interventions  as  global  public  goods.  The  development  of  each  new  vaccine,  drug  or  other
innovative  treatments  requires  large-scale  clinical  trials  in  Developing  countries  costing
several hundred million Euros. The financial goal of € 600 million in the first five years of the
EDCTP  reflects  the  dimension  of  the  problem,  the  need  for  mobilisation  of  different
stakeholders  and  the  challenges  that  have  to  be  overcome  to  significantly  advance  new
clinical interventions.

The Community contribution of € 200 million is calculated to be the substantial but minimum
investment necessary to initiate the EDCTP programme in its first five years. The Community
contribution  should  be  seen  as  a  catalyst  to  ensure  that  a  number  of  promising  new  health
products  are  quickly  brought  into  clinical  trials,  to  create  the  legal  structure  to  establish  the
EDCTP,  and  to  support  a  capacity  building  and  training  programme  in  the  Developing
countries. It provides incentives for the co-operation of national activities, and creates added
value and critical mass at the European and Developing countries levels. Thus the Community
contribution  is  essential  to  create  this  coherent  approach  bringing  together  the  stakeholders
committed  to  the  EDCTP  objectives,  and  to  help  ensure  its  sustainable  long-term
development.

Article 169 as the appropriate instrument for funding the EDCTP

The  fundamental  basis  of  the EDCTP  initiative  is  the  joint  programme  formed  by  the
participating  Member  States’  and  Associated  State’s  national  programmes  and 
the
Community.

Article  169  of  the  Treaty  specifically  allows  the  Community  to  make  provision,  in
implementing  the  Framework  Programme,  for  participation  in  research  and  development
programmes undertaken by several Member States. Therefore the framework of Article 169 is
particularly well adapted to implement the EDCTP initiative as it allows the participation of
the Community in the joint programme.

It ensures the effectiveness of Europe’s investment in national clinical research programmes
by  providing  a  common  platform  that  can  exploit  research  results  to  develop  new  clinical
interventions against HIV/AIDS, malaria and TB for the benefit of the Developing countries.
The  expected  impact  at  the  European  level  will  be  greater  than  the  sum  of  the  impacts  of
national programmes. It will achieve the required critical mass, both in human and financial
terms, by bringing together the available complementary expertise and resources to accelerate
the  development  of  the  new  medical  products  urgently  needed  to  reduce  the  devastating
impact of these three diseases.

Furthermore,  at  the  global  level  it  contributes  to  a  unified  voice  to  represent  European
research  contributions  in  the  fight  against  the  three  diseases  in  the  Developing  countries.

4

Finally, it promotes a long-term structuring effect both in European and developing countries’
research policy and helps to integrate different policies in a coherent context.

The European Community’s  Sixth  Framework  Programme  for  Research  makes  provision  to
establish a clinical trials programme. Article 169 of the Treaty is the appropriate instrument
for the Community to support the EDCTP initiative since it allows for both the coordination
of  national  research  programmes  and  the  participation  of  the  Community  in  the  joint
programme.

Time-scale of this initiative

Since  June  2001,  representatives  from  14  Member  States  -  Austria,  Belgium,  Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden and
the  United  Kingdom  -  and  Norway  -  have  been  working  together  with  the  Commission  to
develop the concept of the EDCTP in close partnership with Developing countries. They have
developed  and  agreed  a  strategic  “Concept  Document”  as  a  starting  point  for  further
elaborating the initiative. This document, which accompanies this proposal without being part
of it, describes the concept of the partnership and the foreseen EDCTP joint programme goals,
activities and implementation modalities.

Based  on  this  Concept  Document  the  participating  States  are  developing  the  legal,  financial
and operational procedures to allow EDCTP activities to begin in Spring 2003, and initiation
of the first EDCTP-funded  clinical  trials  and  capacity  building  and  training  programmes  by
the end of 2003.

5

2002/0211 (COD)

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Articles 169 and 172, second subparagraph, thereof,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the Economic and Social Committee2,

Acting in accordance with the procedure laid down in Article 251 of the Treaty3,

Whereas:

(1) 

(2) 

(3) 

(4) 

1

2

3

4

5

Decision …/…/EC of the European Parliament and of the Council of ... concerning the
Sixth Framework Programme of the European Community for research, technological
development and demonstration activities aimed at contributing toward the creation of
the European Research Area and innovation (2002-2006)4 (hereafter referred to as "the
sixth  framework  programme")  provides  for  Community  participation  in  research  and
development programmes undertaken at the initiative of a number of Member States,
including participation in the structures created for the execution of those programmes,
within the meaning of Article 169 of the Treaty.

On  30  May  2001,  the  Commission  presented  a  communication  on  the  application  of
Article 169 and the networking of national programmes 5.

In its Resolutions of 10 November 2000 and 14 May 2001, the Council underlined the
gravity of the HIV/AIDS, malaria and tuberculosis epidemics and the need to step up
efforts to increase aid at national, regional and world level.

The European Parliament has adopted a resolution and produced a report6 concerning
the  Commission  communications  on  accelerated  action  on  the  main  communicable
diseases in the context of poverty reduction.

OJ C , , p. .
OJ C […], [ …], p. […].
OJ C , , p. .
OJ L […], […], p. […].
COM(2001)282 final

6

                                                
(5) 

(6) 

(7) 

(8) 

(9) 

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  the  initiative  of  a  number  of  Member
States  within  the  meaning  of  Article 169  of  the  Treaty  would  be  appropriate,  if
necessary in close collaboration with the Commission.

In connection with its communications to the Council and the European Parliament of
20 September 20007 and 21 February 20018, 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  a  research  and  development  part  aimed  among  other  things  at
developing,  in  coordination  with  the  application  of  this  decision,  new  clinical
interventions  to  combat  the  three  diseases  through  a  long  term  partnership  between
Europe and the developing countries.

In their Decision No 36/2002/EC of 19 December 20019 the European Parliament and
the  Council  decided  that  the  Community  would  contribute €60  million  for  the  year
2001 to the global fund to fight HIV/AIDS, tuberculosis and malaria.

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Greece,  Ireland,  Italy,  the
Netherlands,  Norway,  Portugal,  Spain,  Sweden  and  the  United  Kingdom  (hereafter
known as "the participating States") are undertaking individual national research and
development programmes or activities aimed at developing 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
a long-term partnership.

At  present,  the  research  and  development  programmes  or  activities  undertaken
individually at national level are not the subject of coordination at European level and
do not allow a coherent approach at European level for an effective campaign against
HIV/AIDS, malaria and tuberculosis.

(10)  Wishing to have a coherent approach at European level and to act effectively against
HIV/AIDS,  malaria  and  tuberculosis,  the  participating  States  agreed  to  establish  a
partnership on clinical trials between European countries and the developing countries
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.

(11)  To  give  effect  to  this  partnership,  the  participating  States  have  developed,  with
developing countries, a research and development programme entitled "The European
and  Developing  countries  Clinical  Trials  Partnership  (hereafter  referred  to  as  the
EDCTP Programme).

(12)  The  objective  of  the  EDCTP  Programme,  the  cost  of  which  is  estimated  by
participating  States  at  €600  million  over  a  five  year  period,  is  to  accelerate  the
to  fight  HIV/AIDS,  malaria  and
development  of  new  clinical 

interventions 

6

7

8

9

A5-0263/2001
COM(2000)585 final
COM(2001)96 final
OJ L 7, 11.01.2002, p. 1.

7

                                                                                                                                                      
tuberculosis  in  the  developing  countries,  particularly  in  Sub  Saharan  Africa.  The
EDCTP Programme has been drawn up with a view to stepping up cooperation and the
networking  of  European  national  programmes,  accelerating  clinical  trails  of  new
products  in  the  developing  countries,  helping  to  strengthen  capacities  in  the
developing countries and obtaining additional funds to fight these diseases.

(13)  The participating States have agreed to develop jointly activities aimed at contributing
to  the  EDCTP  Programme  for  a  period  of  five  years.  The  overall  value  of  their
contribution is estimated at €200  million.

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

(15) 

In  order  to  increase  the  impact  of  the  EDCTP  Programme,  the  Community  should
participate in this programme with a financial contribution of €200  million.

(16)  The participating States have decided to create a common structure to implement the
EDCTP Programme which will be the sole beneficiary of the Community contribution.
This  structure  is  a  legal  entity  which  will  guarantee  the  Community  dimension  in
carrying out the EDCTP Programme.

(17)  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  biotechnology  for  health"  of
the  sixth  framework  programme,  the  financial  contribution  from  the  Community
should be taken from the budget allocated to that priority theme.

(18)  As the EDCTP Programme is being undertaken jointly by several participating States,
it should be stipulated that those states are jointly and severally liable for carrying out
the activities undertaken under the programme.

(19) 

It  is  essential  that  the  research  activities  carried  out  under  the  EDCTP  Programme
conform to basic ethical principles, particularly those set out in Article 6 of the Treaty
on  the  European  Union  and  in  the  Charter  of  Fundamental  Rights  of  the  European
Union.

HAVE ADOPTED THIS DECISION:

Article 1

1. 

In  implementing  the  sixth  framework  programme  of  the  European  Community  for
research, technological development and demonstration activities aimed at contributing
towards the creation of the European Research Area (2002-2006) (hereafter referred to
as "the sixth framework programme"), adopted by Decision ../../EC, the Community
shall  make  a  financial  contribution  to  the  research  and  development  programme
entitled  "The  European  and  Developing  countries  Clinical  Trials  Partnership"
(hereafter  referred  to  as  "the  EDCTP  Programme")  undertaken  jointly  by  Austria,
Belgium,  Denmark,  Finland,  France,  Germany,  Greece,  Ireland,  Italy, 
the
Netherlands,  Norway,  Portugal,  Spain,  Sweden  and  the  United  Kingdom  (hereafter
referred to as "the participating States").

8

2. 

3. 

1.

2.

3.

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

The financial contribution from the Community shall be paid from the appropriation
allocated  to  the  priority  theme  "Life  sciences,  genomics  and  biotechnology  for
health"  of  the  specific  programme  of  the  sixth  framework  programme  "Integrating
and strengthening Community research".

Article 2

The  financial  contribution  from  the  Community  shall  be  conditional  upon  the
execution of the activities under the EDCTP Programme referred to in the annex to
this  decision  and  the  implementation  of  the  research  and  development  programmes
undertaken at national level by the participating States.

The financial contribution form the Community shall be paid to the structure created
by  the  participating  States  for  the  implementation  of  the  EDCTP  Programme
(hereafter  referred  to  as  "common  structure")  which  shall  be  endowed  with  legal
personality.

The  arrangements  for  the  financial  participation  of  the  Community  and  the  rules
relating  to  intellectual  property  rights  shall  be  adopted  jointly  by  means  of  an
agreement  to  be  concluded  between  the  Commission  and  the  common  structure,  in
accordance with the financial regulation application to the Community budget.

The  participating  States  shall  be  jointly  and  severally  liable  for  carrying  out  the  activities
described in the annex.

Article 3

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  States  and  the  common  structure  shall  make  all  relevant  documents
available to the Commission and the Court of Auditors.

Article 5

The Commission shall communicate all relevant information to the European Parliament, the
Council  and  the  Court  of  Auditors,  and  calls  on  the  participating  States  and  the  common
structure  to  forward  any  additional  information  required  by  the  European  Parliament,  the
Council  and  the  Court  of  Auditors  concerning  the  financial  management  of  the  common
structure.

9

Article 6

This decision is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

10

ANNEX

Description of the activities of the EDCTP Programme

In  cooperation  with  developing  countries,  the  participating  States  have  drawn  up  a  research
and development programme entitled the European and Developing countries Clinical Trials
Partnership (EDCTP).

There are several types of activities under the EDCTP Programme to which the Community
makes  a  financial  contribution  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 European national programmes;

·   of the activities carried out in the developing countries.

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

Activities  linked  directly  to  the  development  of  new  products  against  the  three

2.
diseases (HIV/AIDS, malaria and tuberculosis):

·   support for clinical trials in the developing countries;

·   strengthening of capacities in the developing countries.

Activities  planned  to  ensure  the  development,  visibility  and  sustainability  of  the

3.
EDCTP Programme:

·   activities  to  promote  the  EDCTP  Programme  to  ensure  a  high  profile  at  European  or

international level;

·   activities  linked  to  obtaining  the  necessary  funds  to  enable  the  EDCTP  Programme  to

develop as planned, including beyond the period covered by this decision.

Basic  activities  for  the  EDCTP  Programme  such  as  secretariat  services  and  the

4.
management of information concerning clinical interventions against the three diseases.

11

LEGISLATIVE FINANCIAL STATEMENT

Policy area: Research

Activities: research activities pursuant to the EC Treaty.

TITLE OF ACTION:

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.

1.

BUDGET LINE(S) + HEADING(S)

Subsection  B6  6  Indirect  actions,  B6  611  "Life  sciences,  genomics  and  biotechnology
for health".

2.

2.1.

2.2.

OVERALL FIGURES

Total allocation for action: €200  million for commitment

Period of application

2003-2006

2.3.

Overall multiannual estimate of expenditure:

a)

Schedule of commitment appropriations/payment appropriations (financial intervention)
(see. point 5)

€ million

2003

2004

2005

2006

2007 +

Total

Commitments

Payments

200

20

30

50

60

-

40

200

200

This estimate assumes that the EDCTP is fully operational in early 2003.

2.4.

Compatibility with financial programming and financial perspective

þ Proposal is compatible with existing financial programming.

12

¨ Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial
perspective.

¨ Proposal  may  require  application  of  the  provisions  of  the  interinstitutional

agreement.

3.

LEGAL BASIS

Article 169 of the EC Treaty.

Decision  of  the  European  Parliament  and  of  the  Council  concerning  the  multiannual
framework  programme  2002-2006  of 
the  European  Community  for  research,
technological  development  and  demonstration  activities  aimed  at  contributing  towards
the creation of the European Research Area.

Amended  proposal  for  a  Council  Decision  concerning  the  specific  programme
“Integrating  and  strengthening  the  European  Research  Area”  implementing  the  Sixth
framework  programme  of  the  European  Community  for  research,  technological
development and demonstration activities.

4.

DESCRIPTION AND GROUNDS

4.1.

General Background

In  Europe,  more  than  80%  of  public  research  work  on  behalf  of  the  developing  countries  is
carried out at national level, particularly under national or regional research programmes.

There  is,  however,  little  in  the  way  of  coordination  between  the  national  research  programmes
themselves or with Community programmes.

As endorsed by the Lisbon European Council in March 2000 and fully supported by subsequent
European  Councils,  the  objective  of  the  European  Research  Area  project  is  to  remove  the
barriers  between  research  activities  in  Europe.  To  this  end,  it  entails  greater  coherence  and
coordination of national research activities.

The most powerful form of networking is the joint execution of complete programmes or major
parts of programmes.

An  explicit  part  of  the  objective  of  helping  to  achieve  the  European  Research  Area,  the
Community  research  framework  programme  2002-2006,  as  proposed  by  the  Commission,
provides for Community participation in national research programmes carried out jointly, under
Article 169 of the Treaty.

Use of Article 169, which has not so far been used:

– 

– 

is  a  particularly  appropriate  means  of  implementing,  in  conjunction  with  other
instruments,  a  framework  programme  specifically  designed  to  help  achieve  the
European Research Area;

is an effective means of stimulating cooperation and coordination of research activities
carried out at national or regional level in Europe;

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– 

will also make it possible to achieve results which could not be obtained with the two
other new instruments (networks of excellence and integrated projects), because of the
scale  and  diversity  of  the  resources  employed  and  the  structural  effects  of  the
combination of efforts organised at national level.

Such participation requires well defined actions or initiatives (whether or not they are formally
called "programmes"), on a specific theme or in a specific area, allocated a separate budget and
implemented over a certain period with the aid of clearly defined procedures.

4.2.

Need for Community intervention

Three  major  communicable  diseases  (HIV/AIDS,  malaria,  tuberculosis)  affect  the  developing
countries to an extent that their economic and social development is undermined. Alleviation of
poverty  in  developing  countries  by  combating  these  three  major  diseases  has  emerged  as  a
primary objective of the European Community’s policies, and it is one of the seven priorities of
the Commission’s Action Plan for 2002. In the Commission's policy framework "Programme for
Action on Poverty-Related Diseases", one part of the action relates to enhancing public financing
and  European  coordination  for  the  development  of  new  health  products  to  confront  the  three
diseases, especially in the developing world. In this context, DG Research proposes to participate
in  the  creation  of  the  European  and  Developing  countries  Clinical  Trials  Partnership  with  the
ultimate  aim  of  supporting  clinical  trials  for  new  products  to  fight  HIV/AIDS,  malaria  and
tuberculosis in the developing countries.

At national level, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy,
Norway,  Portugal,  Spain,  Sweden,  the  Netherlands  and  the  United  Kingdom  (participating
States) invest  significant  resources, amounting to more than €200  million  annually,  in  research
programmes  and  related  activities  directed  at  developing  new  interventions  against  the  three
poverty-related  diseases.  However,  while  it  is  recognised  that  large  amounts  of  important
research  results  are  generated,  these  often  fall  short  of  actually  being  transformed  into  clinical
interventions applicable in the developing countries.

This  shortcoming  which  decreases  efficiency  and  impact  of  the  individual participating States'
investments in clinical research for HIV/AIDS, malaria and tuberculosis is caused by:

(1)

(2)

(3)

lack  of  adequate  networking  and  co-ordination  between  the  European  national
programmes causing fragmentation of European research in this field;

major  organisational  and  economic  impediments  to  conducting  clinical  trials  of
sufficient size and ambition to achieve meaningful results;

insufficient  involvement  of  the  developing  countries  where  the  target  diseases  are
endemic, often due to lack of sufficiently developed local clinical research facilities or
sufficiently trained human resources.

4.3.

Objectives of the intervention

To  address  the  above  mentioned  shortcoming,  the  participating  States  have  formed  the
“European and Developing countries Clinical Trials Partnership (EDCTP)” which accordingly is
based on the following three major objectives intrinsically linked to overall European policies:

– 

Improvement  of  networking  and  co-operation  between  the  participating  national
programmes  aimed  at  increasing  their  efficiency  and  impact,  thus  overcoming  the
fragmentation  of  European  research  in  this  field  and  contributing  to  structuring  the
European Research Area.

14

– 

– 

Acceleration  of  the  development  of  new  interventions  by  supporting  and/or  funding
clinical  trials,  thus  promoting  technology  transfer  from  research  results  into  clinical
application, thereby strengthening Europe’s competitiveness on the global market.

Strengthening  the  clinical  research  capacities  in  the  developing  countries  for
establishing  a  sustainable  long  term  and  genuine  partnership  between  Europe  and  the
developing  countries  in  the  fight  against  the  three  poverty-related  diseases.  This  will
contribute to European development and co-operation policies.

The participating States have agreed to pool the activities of their relevant national programmes
that directly contribute to the EDCTP’s objectives by subscribing to the EDCTP’s Programme of
activities.

4.4.

Actions envisaged and means of financing

In cooperation with the developing countries, the participating States have drawn up a research
and  development  programme:  "the  European  and  Developing  countries  Clinical  Trials
Partnership  (EDCTP)  with  a  budget  of  €600  million  over  the  initial  period  of  five  years.
€200  million will come from the participating States and €200  million from the Community, the
sum  of  these  budgets  being  sufficient  and  necessary  to  launch  and  develop  the  EDCTP
Programme. Moreover €200  million will have to come from other donors, including industry.

The breakdown of the budget according to type of activity is as follows:

– 

Basic  activities  for  the  EDCTP  Programme  such  as  secretariat  services  (budget  of
€15  million,  foreseen  to  cover  personnel  costs  of  staff  members  of  a  modest-sized
central  office,  for  office  rent  and  the  acquisition  of  essential  office  facilities  and
services,  and  for  the  obligatory  statutory  meetings  of  the  organisation’s  legal  bodies)
and  management  of  information  on  clinical  research  into  new  products  to  combat  the
three  diseases  in  particular  for  developing  countries  (budget  of  €5  million  for
informatics infrastructures, set-up and continuous conduct of information surveys).

Activities linked to networking and coordination:

– 

– 

European  national  programmes  (budget  of  €15  million  to  support  co-ordination
activities  such  as  joint  programme  meetings  and  measures  for  information  exchange,
and  to  provide  incentives  for  the  joint  implementation  of  clinical  research  activities
including clinical trials as well as to open national programmes for participating groups
from other countries);

activities carried out in the developing countries (budget of €5  million, to establish and
maintain  an  appropriately  staffed  EDCTP  branch  office  in  Africa,  for  office  rent  and
infrastructure including the essential set-up of satellite telecommunication systems, and
to  foster  South-South  networking,  in  particular  the  formation  of  an  operational  DC
Coordinating Committee).

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

Activities  linked  directly  to  the  development  of  new  products  to  combat  the  three  diseases
(HIV/AIDS, malaria and tuberculosis):

– 

Support for clinical trials. Whereas in the EDCTP programme, the budget allocated for
clinical  trials  is €400  million,  it  is  estimated  that  €250  million  is  sufficient  and

15

necessary to launch and develop this activity (initially, €250 million can support 10-20
extended efficacy trials to be conducted in Africa, including trials sites maintenance for
3 years); the remaining €150  million  have  to  be  generated  by  other  sources,  including
industry.

– 

Strengthening  of  capacities  in  the  developing  countries.  Whereas  in  the  EDCTP
programme,  the  budget  allocated  for  this  purpose  is €150  million,  it  is  estimated  that
€100  million  is  sufficient  and  necessary  to  launch  and  develop  this  activity,  covering
costs  for  research  support  to  build  up/strengthen  an  initial  number  of  about  10-20
centralised  clinical  testing  facilities,  and  to  finance  a  number  of  training  schemes  for
African clinicians, scientists, and technical personnel both in Europe and in Africa. The
remaining €50 million will have to be generated from other sources.

Activities  planned  to  ensure  the  development,  visibility  and  sustainability  of  the  EDCTP
programme (€10 million):

– 

– 

Activities to promote the EDCTP programme to ensure a high profile and to develop the
following activities: costs for professional internet presence, production of information
material, conduct of press conferences and representation of the EDCTP at meetings of
other global initiatives and relevant international scientific meetings);

Activities  linked  to  seeking  the  necessary  funds  (which  may  come  from  industry  or
other  donors)  to  enable  the  EDCTP  programme  to  develop  as  planned  (costs  of  a
number  of  professionally  conducted  fund-raising  campaigns  which  require  contracting
consultant and media services);

The  participating  States  will  create  a  European  Economic  Interest  Grouping,  the  «EDCTP–
EEIG» as a dynamic and flexible legal entity to execute the EDCTP’s Programme.

Community funding as well as contributions from other donors and industry will be directed to
this  EDCTP–EEIG  as  the  legal  structure  responsible  for  the  execution  of  the  EDCTP
Programme’s activities.

5.

5.1

FINANCIAL IMPACT

Total financial impact on Part B (over the entire programming period)

5.1.1

Financial intervention - Commitments in €  million

Breakdown by objective

Integrating and strengthening Community research

Life sciences, genomics and biotechnology for health

Life sciences, genomics and biotechnology for health 2003

Budget allocated under the EDCTP programme

Total

12 585

2 255

477.9

200

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6.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

Administrative  follow-up  of  the  EDCTP  programme  during  the  initial  five-year  phase
comes under total administrative costs for research.

7.

7.1

7.2

– 

– 

FOLLOW-UP E AND EVALUATION

Follow-up arrangements

The  EDCTP  programme  will  be  followed  up  in  accordance  with  the  arrangements  set
out in the agreement between the Commission and the EDCTP-EEIG.

Arrangements and schedule for evaluation

Evaluation of the EDCTP programme: The Commission, where appropriate with the
aid  of  suitable  experts,  constantly  monitors  the  progress  of  the  EDCTP  programme  in
relation to the objectives set. In particular it assesses whether the objectives, priorities,
activities,  financial  means  and  management  are  always  in  line  with  the  reality  of  the
situation.

Annual  report:  The  situation  with  regard  to  implementation  of  Article  169  of  the
Treaty is published in the annual report on the Framework Programme presented to the
European  Parliament  and  Council  pursuant  to  Article  173  of  the  Treaty.  This  will
include  among  other  things  the  results  of  the  evaluation  of  the  EDCTP  programme,  a
description  of  the  activities  carried  out  in  connection  with  research  and  technological
development,  creation  of  the  European  Research  Area  and  dissemination  of  results
during the previous year and the work programme for the current year.

8.

ANTI-FRAUD MEASURES

In submitting the reports which could lead to the consolidation of revenue in the accounts of the
EDCTP-EEIG, the participating States and the EDCTP-EEIG will have to make the whole of the
financial documentation available to the Commission to enable it to carry out its financial audits,
indicating the timetable and consolidation of accounts for the EDCTP-EEIG.

The  Commission  will  where  necessary  carry  out  such  financial  audits,  in  particular  if  it  has
reasons to doubt the accuracy of the accounts in relation to the progress of the work described in
the activity reports.

The  financial  audits  of  the  Community  will  be  carried  out  either  by  its  own  employees  or  by
qualified  accountants  approved  under  the  legislation  governing  the  EDCTP-EEIG.  The
Community  will  be  free  to  choose  the  latter  while  however  avoiding  the  risks  of  conflicts  of
interests which could be pointed out by the participant who is the subject of the audit.

Moreover, in carrying out the research activities, the Commission will ensure that the financial
interests  of  the  European  Communities  are  protected  by  effective  checks  and,  where
irregularities are detected, by proportionate and dissuasive measures and penalties.

To  this  end,  rules  concerning  checks,  measures  and  penalties,  with  references  to  Regulations
Nos 2988/95,  2185/96,  1073/1999  and  1074/1999,  will  be  set  out  in  the  agreement  signed
between the Commission and the EDCTP-EEIG.

In particular, the following points will have to be covered in the agreement:

17

– 

– 

– 

– 

inclusion  of  specific  clauses  to  protect  the  financial  interests  of  the  European
Communities by carrying out checks and inspections of the funds granted;

carrying out of administrative checks as part of anti-fraud measures, in accordance with
Regulations Nos 2185/96, 1073/1999 and 1074/1999;

application  of  administrative  penalties  to  all  irregularities,  whether  deliberate  or
negligent,  in  the  implementation  of  the  agreement,  in  accordance  with  general
Regulation No 2988/95;

the  fact  that  any  recovery  orders  issued  in  the  event  of  irregularities  and  fraud  are
enforceable instruments under Article 256 of the EC Treaty.

18