Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several Member States
Date: 2013-07-10
Institutions: European Commission
Subjects: code of conduct, developing countries, experiment on humans, medicinal product

EUROPEAN 
COMMISSION 

Brussels, 10.7.2013  
COM(2013) 498 final 

2013/0243 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the participation of the Union in a second European and Developing Countries 
Clinical Trials Partnership Programme jointly undertaken by several Member States 

(Text with EEA relevance) 

{SWD(2013) 253 final} 
{SWD(2013) 254 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The European and Developing Countries Clinical Trials Partnership (EDCTP) was established 
in  2003  in  response  to  the  global  health  crisis  caused  by  the  three  main  poverty-related 
diseases — HIV/AIDS, malaria and tuberculosis — and to the EU’s commitment to achieving 
the United Nation’s Millennium Development Goals by 2015. The first EDCTP programme 
(EDCTP1, 2003-2012) is now beyond its active funding period. 

Despite  the  results  and  impact  of  EDCTP  so  far,  the  health  and  socio-economic  burden  of 
poverty-related  diseases  persists  and  hinders  the  sustainable  development  of  developing 
countries,  in  particular  in  sub-Saharan  Africa.  More  than  one  billion  people,  including  400 
million children, are suffering from one or more poverty-related diseases, including neglected 
infectious diseases such as sleeping sickness and worm infections. HIV/AIDS alone kills an 
estimated  2  million  people,  while  malaria  and  tuberculosis  together  kill  an  estimated  2.2 
million  people  annually.  In  addition  to  creating  unnecessary  suffering  and  premature  deaths 
these diseases undermine productivity and increase insecurity and infirmity, thus perpetuating 
the cycle of poverty. Sub-Saharan Africa is disproportionately affected by such diseases, with 
approximately  90 %  of  all  malaria-related  deaths  occurring  in  Africa.  This  region  also 
accounts  for  over  two  thirds  of  all  people  living  with  HIV  and  for  nearly  three  quarters  of 
AIDS-related deaths. 

While  general  improvements  in  nutrition,  sanitation  and  health  infrastructure  are  important, 
the  effective  long-term  control  of  poverty-related  diseases  also  requires  the  development  of 
new or improved medical interventions (products, treatments and vaccines). While there is a 
general lack of such medical products, many of the existing drugs and vaccines currently used 
date  back  to  the  early  20th  century  and,  moreover,  are  no  longer  effective  due  to  the 
emergence  of  drug  resistance  in  these  diseases.  Most  of  the  new  drugs  and  vaccines  under 
development, however, are stuck at the stage of early clinical development. This is mainly due 
to the significant costs involved in the clinical development and testing needed in humans to 
prove the effectiveness and safety of new or improved medical interventions. These costs are 
linked to three key problem drivers: (i) insufficient investment by the private sector due to a 
lack  of  return  on  investment  (market  failures),  (ii)  weak  clinical  research  capacity  in  sub-
Saharan African countries, and (iii) fragmented public support. 

Following the recommendations from the independent interim evaluation of EDCTP1 and the 
conclusions  from  the  Member  States’  meeting  in  September  2010,  the  Belgian  EU  Council 
Presidency proposed to the Competitiveness Council on 26 November 2010 the launch of a 
second EDCTP joint programme (EDCTP2) with at least ten years duration. To that end, the 
EDCTP1 participating states published a Strategic Business Plan 2014-2024 for EDCTP2. 

On these grounds, the Commission puts forward a proposal for a Decision on the participation 
of  the  EU  in  a  second  European  and  Developing  Countries  Clinical  Trials  Partnership 
Programme  (EDCTP2)  based  on  Article  185  of  the  Treaty  on  the  Functioning  of  the  EU, 
which  makes  provision  for  the  EU  to  participate  in  research  and  development  programmes 
undertaken by several Member States. 

Aim of EDCTP2 

The general objective of EDCTP2 is to improve the EU'’s capacity to invest more efficiently 
in the research and development of new or improved medical interventions against poverty-
related diseases for the benefit of and in partnership with developing countries, in particular 
sub-Saharan African countries. 

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More specifically, EDCTP2 aims to achieve the following specific objectives: 

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An  increased  number  of  new  or  improved  medical  interventions  for  HIV/AIDS, 
tuberculosis,  malaria  and  other  poverty-related  diseases,  and  by  the  end  of  the 
programme  to  have  delivered  at  least  one  new  medical  intervention,  such  as  a  new 
drug or a new vaccine against TB or any other poverty-related disease; to have issued 
at least 30 guidelines for improved or extended use of existing medical interventions; 
and  to  have  progressed  the  clinical  development  of  at  least  20  candidate  medical 
interventions. 

Strengthened  cooperation  with  sub-Saharan  African  countries,  in  particular  on 
building  their  capacity  for  conducting  clinical  trials  in  full  compliance  with 
fundamental  ethical  principles  and  relevant  national,  Union  and  international 
legislation,  including  the  EU’s  Charter  of  Fundamental  Rights,  the  European 
Convention on Human Rights and its Supplementary Protocols, the 2008 version of 
the World Medical Association’s Declaration of Helsinki and the standards on good 
clinical practice of the International Conference on Harmonisation. 

Better  coordination,  alignment  and  integration  of  relevant  national  programmes  to 
increase the cost-effectiveness of European public investments. 

Extended international cooperation with other public and private funders. 

An  increased  impact  due  to  effective  cooperation  with  relevant  EU  initiatives, 
including EU development assistance. 

EDCTP2  has  been  conceived  to  complement  the  actions  implemented  under  the  European 
Development  Funds  and  the  Development  Cooperation  Instruments,  and  to  respond  to  the 
Union’s  commitment  to  the  2012  Rio+20  conference  conclusions  on  developing  and 
achieving internationally agreed Sustainable Development Goals, following and including the 
Millennium Development Goals. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

The  preparation  of  the  proposal  has  taken  full  account  of  the  responses  received  to  an 
extensive stakeholder consultation, including a public consultation. Views were expressed by 
European  and  African  policy  makers  as  well  as  stakeholders  from  industry,  academia  and 
civil  society.  The  proposal  also  relies  on  the  external  interim  evaluations  of  the  EDCTP1 
programme  and  the  in-depth  impact  assessment  of  the  prospective  EDCTP2  programme. 
These consultations, evaluations and assessments of the EDCTP consistently call for it to be 
continued but with the next programme lasting 10 years and covering a scope that extends to 
other poverty-related diseases (beyond HIV/AIDS, tuberculosis and malaria) and to all phases 
of clinical development. The geographical focus should continue to be on sub-Saharan Africa, 
which is disproportionally affected by poverty-related diseases and with which the Union has 
established a strategic partnership. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1 Legal basis 

The  proposal  for  the  EDCTP2  Programme  is  based  on  Article  185  of  the  Treaty  on  the 
Functioning of the EU, which allows the Union, in implementing the multiannual framework 
programme,  to  make  provision,  for  participation  in  research  and  development  programmes 

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undertaken  by  several  Member  States,  in  agreement  with  the  Member  States  concerned, 
including participation in the structures created for the execution of those programmes. 

3.2 Subsidiarity principle 

The  fundamental  basis  of  the  EDCTP  initiative  is  the  joint  programme  being  based  on  and 
composed  of  national  programmes  and  activities  of  the  participating  Member  States  and 
Associated Countries, with the support and participation of the Union. 

It  improves  cost-effectiveness  of  Europe’s  investment  in  clinical  research  programmes  by 
providing a common platform that can better exploit research results for the development of 
new  or  improved  medical  interventions  against  HIV/AIDS,  malaria,  tuberculosis  and  other 
poverty-related  diseases  for  the  benefit  of  the  developing  countries,  in  particular  in  sub-
Saharan Africa. The expected impact at the European level will be greater than the sum of the 
impacts of national programmes and activities. It will allow the required critical mass to be 
achieved, both in human and financial terms, by bringing together available complementary 
expertise  and  resources  to  accelerate  the  development  of  new  or  improved  medical 
interventions  that  are  urgently  needed  to  reduce  the  devastating  impact  of  poverty-related 
diseases  in  developing  countries.  Furthermore,  at  the  global  level  it  contributes  to  a  unified 
voice to represent European research efforts in the fight against these diseases in developing 
countries.  Finally,  it  promotes  a  long-term  structuring  effect  on  European  and  developing 
countries’  research  policies  and  systems  alike,  and  helps  to  integrate  the  EU’s  research  and 
development policies and systems in a coherent context. 

The  Commission’s  proposal  for  Horizon  2020  makes  provision  for  the  Union’s  continued 
participation  in  a  second  EDCTP  programme  under  Article  185  of  the  Treaty,  which  is  the 
appropriate  instrument  for  the  Union  to  support  the  EDCTP  since  it  allows  for  both  the 
coordination of national research programmes and the participation of the Union in the joint 
programme. 

3.3 Proportionality principle 

The  proposal  does  not  go  beyond  what  is  necessary  to  achieve  its  objectives.  Union 
participation in the EDCTP2 Programme will take place within the limits of the competence 
provided  by  the  Treaty  and  will  only  facilitate  and  support,  including  financially,  the 
fulfilment of the EDCTP2 objectives by the participating states. They will have to collaborate 
and work towards reaching better coordination, alignment and integration of relevant national 
programmes  or  activities  and  ultimately  developing  more  and  better  medical  interventions 
against HIV/AIDS, tuberculosis, malaria, as well as other poverty related diseases. 

4. 

BUDGETARY IMPLICATION 

The  Legislative  Financial  Statement  presented  with  this  decision  sets  out  the  indicative 
budgetary  implications.  The  Union  contribution  shall  be  up  to  EUR  683  million1  including 
EFTA contribution. The envelope is in current prices. The Union contribution shall be made 
from the ‘Health, demographic change and wellbeing’ challenge, DG Research & Innovation 
envelope,  as  part  of  the  implementation  of  Horizon  2020  –  The  Framework  Programme  for 
Research  and  Innovation.  The  maximum  amount  of  Union  contribution  for  administrative 
costs is up to EUR 41 million. 

1 

The amount is indicative and will depend on the final amount for the DG Research & Innovation under 
the above-mentioned challenge.  

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During  the  course  of  the  action,  the  Union  may  consider  matching  additional  commitments 
from  Participating  Member  States  or  countries  associated  to  Horizon  2020  Framework 
Programme.  

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2013/0243 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the participation of the Union in a second European and Developing Countries 
Clinical Trials Partnership Programme jointly undertaken by several Member States 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Articles 185 and the second paragraph of Article 188 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 
Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

In  its  Communication  Europe  2020  A  Strategy  for  smart,  sustainable  and  inclusive 
growth3, the Commission underscores the need to develop favourable conditions for 
investment  in  knowledge  and  innovation  so  as  to  achieve  smart,  sustainable  and 
inclusive growth in the Union. The European Parliament and Council have endorsed 
this strategy. 

Horizon  2020  —  The  Framework  Programme  for  Research  and  Innovation  (2014-
2020) established by Regulation (EU) No …/2013 of the European Parliament and of 
the Council of … 20134 (hereinafter “Horizon 2020 Framework Programme”) aims 
at  achieving  a  greater  impact  on  research  and  innovation  by  contributing  to  the 
strengthening of public-public partnerships, including through Union participation in 
programmes undertaken by several Member States in accordance with Article 185 of 
the Treaty. 

By 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 States5, the Community decided to make a 
financial  contribution  to  the  European  and  Developing  Countries  Clinical  Trials 
Partnership (hereinafter ''EDCTP1'') matching that of the participating states but not 
exceeding EUR 200 million, for the duration of the Sixth Framework Programme of 
technological  development  and 
research, 
the  European  Community 

for 

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OJ C …[ESC opinion]. 
COM(2010)2020 final of 3.3.2010. 
OJ... [Horizon 2020 Framework Programme]. 
OJ L 169 of 8.7.2003, p. 1-5. 

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demonstration activities, contributing to the creation of the European Research Area 
and  to innovation (2002 to 2006) established by Decision No 1513/2002/EC of the 
European  Parliament  and  of  the  Council  of  27  June  20026.  EDCTP1  was  also 
supported  under  the  Seventh  Framework  Programme  of  the  European  Community 
for research, technological development and demonstration activities (2007 – 2013) 
established  by  Decision  No  1982/2006/EC  of  the  European  Parliament  and  of  the 
Council of 18 December 20067. 

In  2009,  independent  experts  adopted  the  report  of  the  interim  evaluation  of 
EDCTP18.  The  opinion  of  the  expert  panel  was  that  EDCTP1  provided  a  unique 
platform for a genuine dialogue with African scientists and it has started to bridge the 
gap  between  North  and  South  in  building  research  capacities  and  in  providing 
learning  and  working  opportunities  for  young  African  researchers.  Following  this 
report,  there  are  fundamental  issues  to  be  taken  into  consideration  for  a  second 
European  and  Developing  Countries  Clinical  Trials  Partnership  Programme 
(hereinafter  ''EDCTP2  Programme''):  the  current  scope  of  EDCTP1  needs  to  be 
changed  and  extended;  the  integration  of  European  national  programmes  should  be 
further  improved;  collaboration  with  other  major  public  and  private  funders, 
including  the  pharmaceutical  industry,  needs  to  be  strengthened  and  extended; 
synergies  with  European  external  policy  actions  should  be  developed,  in  particular 
with  Union  development  assistance;  co-funding  rules  should  be  clarified  and 
simplified; monitoring tools need to be strengthened.  

According  to  Council  Decision  …  /2013/EU  of  …  2013  establishing  the  Specific 
Programme implementing Horizon 2020 - The Framework Programme for Research 
and  Innovation  (2014-2020)9  further  support  may  be  provided  to  the  EDCTP2 
Programme. 

EDCTP1 had major achievements and has so far developed eight improved medical 
treatments,  in  particular  for  new-borns,  children  or  pregnant/lactating  women 
suffering  from  HIV/AIDS  or  malaria.  It  has  resulted  in  the  launch  of  the  first  four 
African  Regional  Networks  of  Excellence  promoting  South-South  cooperation  on 
clinical research and more than 400 African researchers have been trained. It has also 
contributed to establishing the Pan-African Clinical Trials Registry and the African 
Vaccine Regulators Forum. 

Despite  the  considerable  results  and  achievements  of  EDCTP1,  poverty-related 
diseases still represent a major obstacle to the sustainable development of developing 
countries due to their social and economic burden, especially in sub-Saharan Africa. 
Effective, safe and affordable medical treatments still do not exist for most poverty-
related diseases and investment in clinical research remains inadequate as conducting 
clinical trials is costly and the return on investment is limited due to market failure. 
Moreover,  European  research  activities  and  programmes  are  still  often  fragmented 
and  thus  either  subcritical  in  scale  or  overlapping,  whereas  research  capacity  and 
investment in developing countries are inadequate. 

The European Parliament adopted a resolution on 15 June 2010 on progress towards 
achieving the Millennium Development Goals (hereinafter ''MDG'') ahead of the UN 
high-level  meeting  in  September  2010  in  which  it  ‘asks  the  Commission,  the 

OJ L 232 of 29.8.2002, p. 1-33. 
OJ L 412 of 30.12.2006, p. 1-43. 
Van Velzen et al., Independent External Evaluation Report, December 2009. 
OJ L … [Horizon 2020 Specific Programme]. 

(4) 

(5) 

(6) 

(7) 

(8) 

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(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

(16) 

(17) 

(18) 

Member States and developing countries to address MDG 5 (on improving maternal 
health),  MDG  4  (on  child  mortality)  and  MDG  6  (on  HIV/AIDS,  malaria  and 
tuberculosis) in a coherent and holistic way’. 

The Union is committed to the 2012 Rio+20 conference conclusions on developing 
and  achieving  internationally  agreed  Sustainable  Development  Goals  (hereinafter 
‘‘SDG’), following and including the MDG. 

In 2000 the Union launched a high-level policy dialogue with Africa leading to the 
establishment of an Africa-EU Strategic Partnership, following which a Joint Africa-
EU  Strategy  was  adopted  in  2007  and  a  high-level  policy  dialogue  on  Science, 
Technology and Innovation was established in 2011. 

The Commission presented a communication on 31 March 2010 on the Union’s role 
in global health10 which calls for a more coordinated approach among Member States 
and across relevant policies to identify and jointly address shared global priorities for 
health research. 

The Commission presented a communication on 21 September 2011 on partnering in 
research  and  innovation11  which  puts  partnerships  across  institutional,  national  and 
continental borders at the centre of the Union’s research policy. 

In  line  with  the  objectives  of  Horizon  2020  Framework  Programme,  any  Member 
State and any country associated to the Horizon 2020 Framework Programme should 
be entitled to participate in the EDCTP2 Programme.  

The  participating  states  intend  to  contribute  to  the  implementation  of  EDCTP2 
Programme during the period covered by the EDCTP2 Programme (2014 – 2024). 

A  ceiling  should  be  established  for  the  Union's  participation  in  EDCTP2  for  the 
duration  of  Horizon  2020  Framework  Programme.  Within  that  ceiling,  the  Union 
contribution  should  be  equal  to  the  initial  contributions  committed  by  the 
participating  states  in  order  to  achieve  a high  leverage  effect  and  ensure  a  stronger 
integration of participating states' programmes. That ceiling should also provide for 
matching  the  contributions  from  any  other  Member  State  or  country  associated  to 
Horizon  2020  Framework  Programme  joining  the  EDCTP2  Programme  during  the 
Horizon 2020 Framework Programme.  

The  Union’s  financial  contribution  should  be  subject  to  formal  commitments  from 
the participating states to contribute to implement the EDCTP2 Programme and their 
fulfilment.  

The  joint  implementation  of  the  EDCTP2  Programme  requires  an  implementation 
structure.  The  participating  states  have  agreed  on  the  implementation  structure  for 
EDCTP2 and set up the EDCTP2-Implementation Structure (hereinafter ‘‘EDCTP2-
IS’’). The EDCTP2-IS should be the recipient of the Union’s financial contribution 
and should ensure efficient implementation of the EDCTP2 Programme. 

The  Union’s  financial  contribution  should  be  managed  in  compliance  with  the 
principle  of  sound  financial  management  and  in  accordance  with  the  relevant  rules 
on  indirect  management  set  out  in  Regulation  (EU,  Euratom)  No  966/2012  of  the 
European  Parliament  and  the  Council  of  25  October  2012  on  the  financial  rules 
applicable  to  the  general  budget  of  the  Union12  and  Commission  Delegated 

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COM(2010)128 final. 
COM(2011) 572 final. 
OJ L 298 of 26.10.2012, p. 1-96. 

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(19) 

(20) 

(21) 

(22) 

(23) 

(24) 

(25) 

(26) 

(27) 

Regulation  (EU)  No  1268/2012  of  29  October  2012  on  the  rules  of  application  of 
Regulation (EU, Euratom) No 966/201213. 

In order to protect the Union’s financial interests,  the Commission should have the 
right  to  reduce,  suspend  or  terminate  the  Union’s  financial  contribution  if  the 
EDCTP2  Programme  is  implemented  inadequately,  partially  or  late,  or  if  the 
participating states do not contribute, or contribute partially or late, to the financing 
of  the  EDCTP2  Programme.  Those  rights  should  be  provided  for  in  the  delegation 
agreement to be concluded between the Union and the EDCTP2-IS. 

In order to efficiently implement the EDCTP2 Programme, financial support should 
be provided by the EDCTP2-IS mainly in the form of grants to participants in actions 
selected  at  the  level  of  the  EDCTP2-IS.  The  selection  of  these  actions  should  be 
made following open and competitive calls for proposals under the responsibility of 
the EDCTP2-IS. 

Participation  in  indirect  actions  under  the  EDCTP2  Programme  is  subject  to 
Regulation  (EU)  No  …/2013  of  the  European  Parliament  and  of  the  Council  of  … 
2013 laying down the rules for the participation and dissemination in Horizon 2020 
Framework Programme for Research and Innovation (2014-2020)14. However, due to 
specific  operating  needs  of  the  EDCTP2  Programme  it  is  necessary  to  provide  for 
derogations from that Regulation in accordance with Article 1(3) of that Regulation.  

Derogations from Articles 8(1)(b), 9(1)(c) and 11 of Regulation (EU) No …/2013 are 
necessary in order to require participation and allow funding of African entities, and 
allow  cooperation  through  joint  calls  between  the  EDCTP2  Programme  and  any 
other legal entity. 

Audits of recipients of Union funds provided in accordance with this Decision should 
ensure  a  reduction  of  administrative  burden,  in  compliance  with  the  Horizon  2020 
Framework Programme. 

The Union’s financial interests should be protected through proportionate measures 
throughout  the  expenditure  life-cycle,  including  the  prevention,  detection  and 
investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly 
used  and,  where  appropriate,  administrative  and  financial  penalties  in  accordance 
with Regulation (EU, Euratom) No 966/2012. 

The  Commission  should  conduct  interim  evaluations,  assessing  in  particular  the 
quality  and  efficiency  of  EDCTP2,  progress  towards  the  objectives  set  and  a  final 
evaluation and prepare reports on those evaluations. 

Upon request from the Commission, EDCTP2-IS and the participating states should 
submit  any  information  the  Commission  needs  to  include  in  the  reports  on  the 
evaluation of the EDCTP2 Programme. 

It is essential that the research activities carried out under the EDCTP2 Programme 
are  in  full  compliance  with  the  Charter  of  Fundamental  Rights  of  the  European 
Union, the European Convention on Human Rights and its Supplementary Protocols, 
ethical  principles  included  in  the  World  Medical  Association's  Declaration  of 
Helsinki of 2008, the standards of good clinical practice adopted by the International 
Conference  on  Harmonisation  of  Technical  Requirements  for  Registration  of 

13 
14 

OJ L 362 of 31.12.2012, p. 1-111. 
OJ [H2020 RfP]. 

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Pharmaceuticals  for  Human  Use,  relevant  EU 
requirements of the countries where the research activities are to be conducted. 

legislation  and 

local  ethics 

(28) 

Since  the  objectives  of  this  Decision,  namely  to  contribute  to  the  reduction  of  the 
social and economic burden of poverty-related diseases in developing countries and 
in  particular  in  sub-Saharan  Africa  by  accelerating  the  clinical  development  of 
effective,  safe  and  affordable  medical  interventions  for  poverty-related  diseases, 
cannot  be  sufficiently  achieved  by  the  Member  States  due  to  the  lack  of  necessary 
critical mass to be achieved, both in human and financial terms, and can therefore, by 
reason of the scale of the action, be better achieved at Union  level, the Union may 
adopt measures, in accordance with the principle of subsidiarity as set out in Article 
5  of  the  Treaty  on  the  European  Union.  In  accordance  with  the  principle  of 
proportionality, as set out in that Article, this Decision does not go beyond what is 
necessary for that purpose. 

HAVE ADOPTED THIS DECISION: 

Article 1 

Participation in the second European and Developing Countries Clinical Trials Partnership 
Programme 

1. 

2. 

The  Union  shall  participate  in  the  second  European  and  Developing  Countries 
Clinical  Trials  Partnership  Programme  (hereinafter  ‘the  EDCTP2  Programme’), 
jointly undertaken by Belgium, Denmark, Germany, Ireland, Greece, Spain, France, 
Italy,  Luxembourg,  the  Netherlands,  Austria,  Portugal,  Sweden,  and  the  United 
Kingdom  as  well  as  Switzerland  and  Norway  (hereinafter  ''participating  states'')  in 
accordance with the conditions set out in this Decision. 

(EU)  No  …/2013… 

Any other Member State and any other country associated to the Horizon 2020 – The 
Framework  Programme  for  Research  and  Innovation  (2014  –  2020)  established  by 
Regulation 
(hereinafter  “Horizon  2020  Framework 
Programme“)  may  participate  in  the  EDCTP2  Programme  provided  it  fulfils  the 
criterion  set  out  in  Article  3(1)(e)  of  this  Decision.  Those  Member  States  and 
countries  associated  to  the  Horizon  2020  Framework  Programme  that  fulfil  the 
condition set out in Article 3(1)(e) shall be regarded as ‘participating states’ for the 
purposes of this Decision. 

Article 2 

Union's financial contribution 

1. 

The  maximum  Union  financial  contribution,  including  EFTA  appropriations,  to  the 
EDCTP2 Programme shall be EUR 683 million, as follows: 

(a)  EUR  594  million  to  equal  the  contributions  of  participating  states  listed  in 

article 1.1; 

(b)  EUR  89  million  to  equal  the  contributions of any other Member State or any 
other country associated to Horizon 2020 Framework Programme participating 
in the EDCTP2 Programme in accordance with Article 1.2. 

2. 

The  contribution  shall  be  paid  from  the  appropriations in the  general  budget  of  the 
Union  allocated  to  the  relevant  parts  of  the  Specific  Programme  implementing 
Horizon  2020  Framework  Programme,  established  by  Decision  …  /2013/EU  in 

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accordance  with  Article  58(1)(c)(vi)  and  Articles  60  and  61  of  Regulation  (EU, 
Euratom) No 966/2012. 

3. 

Up  to  6%  of  the  Union’s  financial  contribution  may  be  used  by  the  implementing 
structure of EDCTP2 (hereinafter ''EDCTP2-IS'') to cover its administrative costs. 

Article 3 

Conditions for the Union’s financial contribution 

1. 

The Union’s financial contribution shall be conditional upon the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  demonstration  by  the  participating  states  that  the  EDCTP2  Programme  is 
set up in accordance with Annexes I, II and III to this Decision; 

the  designation  by  the  participating  states  or  organisations  designated  by  the 
participating  states  of  the  EDCTP2-IS,  an  entity  with  legal  personality  as  the 
structure  responsible  for  implementing  the  EDCTP2  Programme  and  for 
receiving,  allocating  and  monitoring  the  participating  states'  contribution,  as 
well as the Union’s financial contribution; 

the demonstration by the EDCTP2-IS of its capacity to implement the EDCTP2 
Programme  including  receiving,  allocating  and  monitoring  the  Union’s 
contribution in the framework of indirect management of the Union budget in 
accordance  with  Articles  58,  60  and  61  of  Regulation  (EU,  Euratom)  No 
966/2012; 

the  establishment  of  a  governance  model  for  the  EDCTP2  Programme  in 
accordance with Annex III;  

the commitment by each participating state to contribute to the financing of the 
EDCTP2 Programme.  

2. 

During  the  implementation  of  the  EDCTP2  Programme,  the  Union  financial 
contribution shall be conditional upon the following: 

(a) 

(b) 

(c) 

the implementation by the EDCTP2-IS of the objectives set out in Annex I and 
activities  set  out  in  Annex  II  to  this  Decision,  in  particular  the  activities  and 
indirect  actions  that  it  funds,  in  compliance  with  Regulation  (EU)  No  … 
referred to in Article 6; 

the  maintenance  of  an  appropriate  and  efficient  governance  model  for  the 
EDCTP2 Programme in accordance with Annex III to this Decision; 

the  compliance  by  the  EDCTP2-IS  with  the  reporting  requirements  set  out  in 
Article 60(5) of Regulation (EU, Euratom) No 966/2012; 

(d) 

the fulfilment of the commitments referred to in point (e) paragraph 1.  

Article 4 

Activities of the EDCTP2 Programme 

1. 

The  activities  of  the  EDCTP2  Programme  shall  meet  the  objectives  described  in 
Annex I to this Decision and comply with Annex II. 

Activities may include national programme activities of participating states and new 
activities, including calls for proposals managed by the EDCTP2-IS. 

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Activities  shall  be  included  in  the  work  plan  of  the  EDCTP2  Programme  adopted 
annually  by  the  EDCTP2-IS  following  the  positive  outcome  of  their  external 
evaluation  by  international  peer  review  based  on  Article  14(1)  of  Regulation  (EU) 
No  …  [Rules  for  the  participation  and  dissemination  in  Horizon  2020],  and  with 
regard to their contribution to the objectives of the EDCTP2 Programme. 

2. 

The  work  plan  shall  detail  the  budgeted  value  of  each  activity  and  provide  for  the 
allocation  of  the  funding  managed  by  the  EDCTP2-IS,  including  the  Union 
contribution. 

The work plan shall differentiate between the activities funded or co-funded by the 
Union and those funded by participating states or other revenues. 

3. 

The EDCTP2-IS shall implement the annual work plan referred to in paragraph 1. 

4. 

The EDCTP2-IS shall monitor and report to the Commission on the implementation 
of  all  the  activities  included  therein  or  selected  following  calls  for  proposals 
managed by the EDCTP2-IS. 

Activities included in the work plan that are not funded by the EDCTP2-IS shall be 
implemented in compliance with common principles to be agreed by the participating 
states and the Commission, taking into account the principles set out in this Decision, 
in Title VI of Regulation (EU, Euratom) No 966/2012 and in Regulation (EU) No … 
[Rules for the participation and dissemination in Horizon 2020], in particular equal 
treatment,  transparency,  independent  peer  review  evaluation  and  selection.  The 
participating  states  and  the  Commission  shall  also  agree  on  the  reporting 
requirements  to  the  EDCTP2-IS,  including  with  regard  to  indicators  inserted  into 
each of these activities. 

Any activity funded by EDCTP2-IS in accordance with the work plan or following 
calls  for  proposals  managed  by  the  EDCTP2-IS,  shall  be  considered  as  an  indirect 
action under the meaning of Regulation (EU) No … [Rules for the participation and 
dissemination in Horizon 2020] and be implemented in accordance with Article 6. 

5. 

Any communication or publication related to activities of the EDCTP2 Programme, 
whether  undertaken  by  the  EDCTP2-IS,  a  participating  state,  or  participants  to  an 
activity,  shall  be  labelled  or  co-labelled  as  "[name  of  the  activity]  is  part  of  the 
EDCTP2 programme supported by the European Union". 

Article 5 

Contributions from participating states  

1. 

Contributions from the participating states shall consist of the following: 

(a) 

(b) 

financial contributions to the EDCTP2-IS;  

in kind contributions consisting of the costs incurred by the participating states 
in implementing activities included in the work plan referred to in Article 4(1) 
or in relation to the administrative budget of the EDCTP2-IS. 

2. 

For the purpose of evaluating the contributions referred to in point (b) of paragraph 
1,  the  costs  shall  be  determined  according  to  the  usual  accounting  practices  and 
accounting  standards  of  the  participating  state  concerned  and  to  the  applicable 
International Accounting Standards /International Financial Reporting Standards. 

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1. 

2. 

3. 

4. 

1. 

2. 

Article 6 

Rules for participation and dissemination 

Regulation  (EU)  No  …  [Rules  for  the  participation  and  dissemination  in  Horizon 
2020] shall apply to indirect actions selected and funded by EDCTP-IS in accordance 
with  the  work  plan  referred  to  in  Article  4(1)  or  following  calls  for  proposals 
managed by EDCTP2-IS. In accordance with that Regulation, the EDCTP2-IS shall 
be considered a funding body and shall provide financial support to indirect actions 
in accordance with Annex II to this Decision. 

By  derogation  from  Article  8(1)(b)  of  Regulation  (EU)  No  …  [Rules  for  the 
participation  and  dissemination  in  Horizon  2020],  the  minimum  number  of 
participants shall be two legal entities established in two different participating states 
and a third legal entity in a sub-Saharan African country listed in the EDCTP2 work 
plan referred to in Article 4(1) of this Decision. 

By  derogation  from  Article  9(1)(c)  of  Regulation  (EU)  No  …  [Rules  for  the 
participation  and  dissemination  in  Horizon  2020],  any  legal  entity  established  in  a 
sub-Saharan  country  listed  in  the  EDCTP2  work  plan  referred  to  in  Article  4(1)  of 
this Decision shall be eligible for funding. 

Where  such  an  activity  is  included  in  the  workplan,  EDCTP2-IS  may  launch  joint 
calls  with  third  countries  or  their  scientific  and  technological  organisations  and 
agencies,  with  international  organisations  or  with  other  third  parties,  in  particular 
non-governmental  organisations,  in  accordance  with  the  rules  developed  based  on 
Article 11 of Regulation (EU) No … [Rules for the participation and dissemination 
in Horizon 2020]. 

Article 7 

Agreements between the Union and the EDCTP2-IS 

Subject  to  a  positive  ex-ante  assessment  of  the  EDCTP2-IS  in  accordance  with 
Article  61(1)  of  Regulation  (EU,  EURATOM)  No  966/2012,  the  Commission,  on 
behalf  of  the  Union,  shall  conclude  a  delegation  agreement  and  annual  transfer  of 
funds agreements with the EDCTP2-IS. 

The  delegation  agreement  referred  to  in  paragraph  1  shall  be  concluded  in 
accordance with Articles 58(3), 60 and 61 of Regulation (EU, Euratom) No 966/2012 
and  Article  40  of  Delegated  Regulation  (EU)  No  1268/2012.  It  shall  also  set  out, 
inter alia, the following: 

(a) 

(b) 

(c) 

(d) 

the  requirements  for  the  EDCTP2-IS  contribution  regarding  the  performance 
indicators set out in Annex II to Decision (EU) No … [the Specific Programme 
implementing the Horizon 2020 Framework Programme]; 

the requirements for the EDCTP2-IS contribution in relation to the monitoring 
referred  to  in  Annex  III  to  Decision  (EU)  No  …  [the  Specific  Programme 
implementing the Horizon 2020 Framework Programme]; 

the specific performance indicators related to the functioning of the EDCTP2-
IS; 

the requirements for the EDCTP2-IS regarding the provision of information on 
administrative costs and on detailed figures concerning the implementation of 
the EDCTP2 Programme;  

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(e) 

(f) 

the  arrangements  regarding  the  provision  of  data  necessary  to  ensure  that  the 
Commission is able to meet its dissemination and reporting obligations; 

the modalities for approval or rejection by the Commission of the draft annual 
work plan of the EDCTP2 Programme  referred to in Article 4(1), before it is 
adopted by the EDCTP2-IS. 

Article 8 

Termination, reduction or suspension of the Union’s financial contribution 

If the EDCTP2 Programme is not implemented or is implemented inadequately, partially or 
late, the Commission may terminate, proportionally reduce or suspend the Union’s financial 
contribution in line with the actual implementation of the EDCTP2 Programme. 

If the participating states do not contribute, contribute partially or late to the financing of the 
EDCTP2  Programme,  the  Commission  may  terminate,  proportionally  reduce  or  suspend  the 
Union’s  financial  contribution,  taking  into  account  the  amount  of  funding  allocated  by  the 
participating states to implement the EDCTP2 Programme. 

Article 9 

Ex-post audits 

1. 

Ex-post audits of expenditure on indirect actions shall be carried out by EDCTP2-IS 
in  accordance  with  Article  23  of  Regulation  (EU)  No  …  [the  Horizon  2020 
Framework Programme] . 

2. 

The Commission may decide to carry out the audits referred to in paragraph 1 itself. 

Article 10 

Protection of the financial interests of the Union 

1. 

2. 

3. 

The  Commission  shall  take  appropriate  measures  ensuring  that,  when  actions 
financed under this Decision are implemented, the financial interests of the Union are 
protected by the application of preventive measures against fraud, corruption and any 
other illegal activities, by effective checks and, if irregularities are detected, by the 
recovery  of  the  amounts  wrongly  paid  and,  where  appropriate,  by  effective, 
proportionate and dissuasive administrative and financial penalties. 

The EDCTP2-IS shall grant Commission staff and other persons authorised by it, as 
well  as  the  Court  of  Auditors,  access  to  its  sites  and  premises  and  to  all  the 
information, including information  in electronic format, needed  in  order to  conduct 
their audits. 

The European Anti-fraud Office (OLAF) may carry out investigations, including on-
the-spot  checks  and  inspections,  in  accordance  with  Council  Regulation  (Euratom, 
EC) No 2185/96  15 and Regulation (EC) No 1073/1999 of the European Parliament 
and  of  the  Council16  with  a  view  to  establishing  whether  there  has  been  fraud, 
corruption or any other illegal activity affecting the financial interests of the Union in 
connection  with  an  agreement  or  decision  or  a  contract  funded  in  accordance  with 
this Decision. 

15 
16 

OJ L 292, 15.11.1996, p. 2-5. 
OJ L 136, 31.5.1999, p. 1–7. 

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4. 

5. 

1. 

2. 

3. 

1. 

2. 

3. 

Contracts, grant agreements and grant decisions resulting from the implementation of 
this  Decision  shall  contain  provisions  expressly  empowering  the  Commission,  the 
EDCTP2-IS,  the  Court  of  Auditors  and  OLAF  to  conduct  such  audits  and 
investigations, according to their competences. 

In  implementing  the  EDCTP2  Programme,  the  participating  states  shall  take  the 
legislative, regulatory, administrative and other measures necessary for protecting the 
Union’s financial interests, in particular, to ensure full recovery of any amounts due 
to  the  Union  in  accordance  with  Regulation  (EU,  Euratom)  No  966/2012  and 
Delegated Regulation (EU) No 1268/2012. 

Article 11 

Communication of information 

On request, the EDCTP2-IS shall send any information necessary for preparation of 
the reports referred to in Article 12 to the Commission. 

The  participating  states  shall  submit  to  the  Commission,  through  the  EDCTP2-IS, 
any  information  that  is  requested  by  the  European  Parliament,  the  Council  or  the 
Court of Auditors concerning the financial management of the EDCTP2 Programme. 

The  Commission  shall  include  the  information  referred  to  in  paragraph  2  in  the 
reports referred to in Article 12. 

Article 12 

Evaluation  

By  31  December  2017  the  Commission  shall  conduct  an  interim  evaluation  of  the 
EDCTP2  Programme.  The  Commission  shall  prepare  a  report  on  that  evaluation 
which includes  conclusions of the  evaluation and observations  by  the  Commission. 
The Commission shall send that report to the European Parliament and to the Council 
by 30 June 2018. 

At  the  end  of  the  Union  participation  in  EDCTP2  but  not  later  than  31  December 
2023,  the  Commission  shall  conduct  another  interim  evaluation  of  the  EDCTP2 
Programme.  The  Commission  shall  prepare  a  report  on  that  evaluation  which 
includes the results of that evaluation. The Commission shall send that report to the 
European Parliament and the Council. 

The Commission shall conduct a final evaluation of the EDCTP2 Programme by 31 
December  2026.  The  Commission  shall  send  the  results  of  that  evaluation  to  the 
European Parliament and the Council. 

Article 13 

Entry into force 

This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

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Article 14 

Addressees 

This Decision is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I 
OBJECTIVES OF THE EDCTP2 PROGRAMME 

EDCTP2 shall contribute to the following objectives: 

(1) 

General Objective 

EDCTP2  shall  contribute  to  the  reduction  of  the  social  and  economic  burden  of 
poverty-related diseases in developing countries, in particular in sub-Saharan Africa, 
by  accelerating  the  clinical  development  of  effective,  safe  and  affordable  medical 
interventions for poverty-related diseases, in partnership with sub-Saharan Africa. 

(2) 

Specific Objectives 

In order to contribute to the general objective, EDCTP2 shall achieve the following 
specific objectives: 

(a) 

(b) 

an increased number of new or improved medical interventions for HIV/AIDS, 
tuberculosis, malaria and other poverty-related diseases, and by the end of the 
programme  to  have  delivered  at  least  one  new  medical  intervention;  to  have 
issued at least 30 guidelines for improved or extended use of existing medical 
interventions;  and  to  have  progressed  the  clinical  development  of  at  least  20 
candidate medical interventions; 

strengthened cooperation with sub-Saharan African countries, in particular on 
building  their  capacity  for  conducting  clinical  trials  in  compliance  with 
fundamental  ethical  principles  and  relevant  national,  Union  and  international 
legislation,  including  the  Charter  of  Fundamental  Rights  of  the  European 
Union,  the  European  Convention  on  Human  Rights  and  its  Supplementary 
Protocols,  the  World  Medical  Association’s  Declaration  of  Helsinki  of  2008 
and  the  standards  on  good  clinical  practice  adopted  by  the  International 
Conference  on  Harmonisation  of  Technical  Requirements  for  Registration  of 
Pharmaceuticals for Human Use (ICH); 

(c)  better coordination, alignment and integration of relevant national programmes 

to increase the cost-effectiveness of European public investments; 

(d) 

(e) 

extended international cooperation with other public and private funders; 

an increased impact due to effective cooperation with relevant European Union 
initiatives, including its development assistance. 

(3) 

Operational Objectives 

In order to reach the specific objectives set out in point 2, the following operational 
objectives,  including  indicative  targets,  shall  be  met  by  the  end  of  the  EDCTP2 
programme in 2024: 

(a)  Support clinical trials on new or improved  medical  interventions  for poverty-
related  diseases  through  partnerships  between  European  and  developing 
countries, in particular sub-Saharan Africa: 

Target:  increase  the  number  of  supported  clinical  trials  to  at  least  150 
compared to 88 under EDCTP1. 

Target:  sustain  or  increase  the  proportion  of  clinical  trials  funded  by  the 
EDCTP2-IS with African leadership to at least 50 %. 

Target: Increase the number of peer-reviewed scientific articles published to at 
least 1000. 

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(b)  Support  research  capacity-building  activities  in  sub-Saharan  Africa  enabling 

clinical trials to be conducted and helping to reduce the brain drain: 

Target:  sustain  or  increase  the  number  of  sub-Saharan  African  countries 
supported by the EDCTP2 to at least 30. 

Target: increase the number of fellowships to sub-Saharan African researchers 
and MSc/PhD students to at least 600 compared to 400 under EDCTP1, with at 
least 90 % of them continuing their research career in sub-Sahara Africa for at 
least one year after their fellowship. 

Target:  increase  the  number  of  capacity-building  activities  supported  for 
conducting clinical trials in sub-Saharan Africa to at least 150 compared to 74 
under EDCTP1. 

(c)  Develop  a  common  research  agenda,  criteria  for  priority  setting  and  common 

evaluation: 

Target: at least 50 % of the public investment by participating European states 
are integrated, aligned or coordinated through the EDCTP2 Programme. 

(d)  Ensure efficiency of the implementation of the EDCTP2 Programme: 

Target: administrative costs are below 5 % of the EDCTP2-IS budget. 

(e)  Establish  cooperation  and  launch  joint  actions  with  other  public  and  private 

funders. 

Target:  increase  the  contributions  received  from  developing  countries  to  at 
least EUR 30 million compared to EUR 14 million under EDCTP1. 

Target:  obtain  additional  contributions,  either  public  or  private,  of  at  least 
EUR 500 million compared to EUR 71 million under EDCTP1. 

(f)  Establish  cooperation  and  launch  joint  actions  with  Union,  national  and 
international  development  assistance 
to  ensure 
complementarity  and  increase  the  impact  of  the  results  of  EDCTP-funded 
activities. 

in  order 

initiatives 

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ANNEX II 
ACTIVITIES AND IMPLEMENTATION OF THE EDCTP2 PROGRAMME 

(1) 

Activities 

The EDCTP2 Programme shall include the following activities: 

(a)  promoting networking, coordination, alignment, cooperation and integration of 
national  research  programmes  and  activities  on  poverty-related  infectious 
diseases at scientific, management and financial level; 

(b) 

(c) 

(d) 

(e) 

supporting  clinical  trial  research  and  related  activities  on  poverty-related 
diseases, 
tuberculosis  and  neglected 
infectious diseases; 

in  particular  HIV/AIDS,  malaria, 

fostering  capacity  development  for  clinical  trials  and  related  research  in 
developing  countries  through  grants  for:  career  development  of  junior/senior 
fellows, promoting mobility, staff exchange grants, research training networks, 
strengthening  ethics  and  regulatory  bodies,  mentoring  and  partnerships  at 
individual or institutional level; 

establishing  cooperation  and  launching  joint  actions  with  other  public  and 
private funders; 

assuring  awareness,  endorsement  and  acknowledgment  of  the  EDCTP2 
Programme and its activities through advocacy and communication. 

(2) 

Programme definition and implementation 

The EDCTP2 Programme shall be implemented by the EDCTP2-IS on the basis of 
an annual work plan and a multiannual strategic work plan prepared by the EDCTP2-
IS and adopted by the General Assembly of the EDCTP2-IS following international 
peer-review and subject to the prior approval by the Commission. 

The  annual  work  plan  shall  identify  topics  and  activities  to  be  implemented, 
including calls for proposals to be launched by EDCTP-IS to select and fund indirect 
actions, as well as the budgets and EDCTP2 funding for those topics and activities. 

The annual work plan shall differentiate between the activities funded or co-funded 
by the Union and those funded by participating states or other revenues. 

The  multiannual  strategic  work  plan  shall  set  a  common  strategic  research  agenda 
which shall be prepared and updated on an annual basis. 

EDCTP2-IS  shall  monitor  the  implementation  of  the  activities  included  in  the 
workplan, including indirect actions selected through calls for proposals it manages. 
It  shall  allocate  and  manage  funding  to  these  in  accordance  with  this  Decision  and 
the  effective  implementation  of  activities  selected  and  identified  in  the  previous 
workplans. 

(3) 

Deliverables expected from the implementation of the EDCTP2 Programme 

An  annual  report  shall  be  provided  by  EDCTP2-IS,  which  shall  give  a  detailed 
overview  of  the  implementation  of  the  EDCTP2  Programme.  That  overview  shall 
provide  information  on  each  activity  selected  in  accordance  with  the  work  plan, 
including indirect actions selected through calls for proposals managed by EDCTP-
IS.  Such  information  shall  include  a  description  of  each  activity,  including  indirect 
action, its budget, the value of the funding allocated to it if any, and its status. 

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With  regards  to  calls  managed  by  EDCTP-IS,  the  annual  report  shall  moreover 
include  information  on  the  number  of  projects  submitted  and  selected  for  funding, 
the detailed use of the Union financial contribution, the distribution of national and 
other contributions, the types of participants, country statistics, brokerage events and 
dissemination activities.  

The annual report shall also include information on the progress towards achieving 
the EDCTP2 Programme objectives set out in Annex I. 

In addition, the EDCTP2-IS shall provide any report and information foreseen by this 
Decision and the agreement concluded with the Union. 

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ANNEX III 
GOVERNANCE OF THE EDCTP2 PROGRAMME 

The organisational structure of the EDCTP2 Programme shall comprise the following: 

(1) 

The  EDCTP2-IS  shall  be  governed  by  a  general  assembly  (hereinafter  ''GA''),  in 
which all participating states are represented. 

The GA’s principal responsibility shall be to ensure that all necessary activities are 
undertaken  to  achieve  the  objectives  of  the  EDCTP2  Programme,  and  that  its 
resources are properly and efficiently managed. It shall adopt the annual work plan. 

The GA shall decide by consensus. Failing consensus, the GA shall take its decisions 
by a majority of at least 75 % of the votes. 

The Union, represented by the Commission, shall be invited to all GA meetings as an 
observer, and shall receive all necessary documents. It may take part in discussions.  

(2) 

The GA shall appoint a management board that shall supervise the secretariat of the 
EDCTP2-IS (hereinafter ''SEC'') established by the GA as the executive body of the 
EDCTP2 Programme. 

SEC shall have the following tasks: 

(a) 

represent the EDCTP2-IS; 

(b)  provide support to the GA; 

(c) 

implement  the  EDCTP2  Programme  and  manage  those  of  its  activities 
entrusted to EDCTP2-IS by the annual work plan 

(d)  monitor and report on the implementation of the EDCTP2 Programme; 

(e)  manage the financial contributions from the participating states, the Union and 

any third party, and report on their use to the GA and the Union; 

(f) 

(g) 

increase  the  visibility  of  the  EDCTP2  Programme  through  advocacy  and 
communication; 

liaise  with  the  Commission  in  accordance  with  the  delegation  agreement 
referred to in Article 7. 

(3) 

A  Scientific  Advisory  Committee  (hereinafter  ‘SAC’)  shall  advise  the  GA  on  the 
strategic priorities of the EDCTP2 Programme. 

The  SAC  shall  be  appointed  by  the  GA  and  consist  of  European  and  African 
independent experts competent in areas relevant to the EDCTP2 Programme. 

The SAC shall have the following tasks: 

(a) 

(b) 

advise  the  GA  on  priorities  and  strategic  needs  regarding  clinical  trials  in 
Africa 

review and advise the GA on the content, scope and dimension of the EDCTP2 
draft  annual  work  plan,  including  diseases  covered  and  approaches  to  be 
adopted, from a scientific and technical standpoint 

(c) 

review  the  scientific  and  technical  aspects  of  the  implementation  of  the 
EDCTP2 Programme and deliver an opinion on its annual report 

In exercising its tasks, the SAC shall monitor and promote high standards of ethical 
conduct of clinical trials and engage with vaccine regulatory authorities. 

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The SAC may recommend to the GA the setting up of scientific subcommittees, task 
forces and working groups. 

The  GA  shall  establish  the  number  of  SAC  members,  their  voting  rights  and  the 
modalities of their appointment in accordance with Article 37 of Regulation (EU) No 
… [Rules for the participation and dissemination in Horizon 2020]. The GA may set 
up  specialised  working  groups  under  the  SAC  with  additional  independent  experts 
for specific tasks. 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE 

1.1.  Title of the proposal/initiative 

1.2.  Policy area(s) concerned in the ABM/ABB structure 

1.3.  Nature of the proposal/initiative 

1.4.  Objectives 

1.5.  Grounds for the proposal/initiative 

1.6.  Duration and financial impact 

1.7.  Management mode(s) envisaged 

2. 

MANAGEMENT MEASURES 

2.1.  Monitoring and reporting rules 

2.2.  Management and control system 

2.3.  Measures to prevent fraud and irregularities 

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE 

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected 

3.2.  Estimated impact on expenditure 

3.2.1. Summary of estimated impact on expenditure 

3.2.2. Estimated impact on operational appropriations 

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party contributions 

3.3.  Estimated impact on revenue

EN 

23 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE 

1.1. 

Title of the proposal/initiative 

Decision of the European Parliament and of the Council on the participation of the 
European  Union  in  a  second  European  and  Developing  Countries  Clinical  Trials 
Partnership Programme (EDCTP2) jointly undertaken by several Member States 
Policy area(s) concerned in the ABM/ABB structure17 

1.2. 

Title 08 Research and Innovation, Horizon 2020 Framework Programme 

1.3. 

Nature of the proposal/initiative 

(cid:133) The proposal/initiative relates to a new action 

(cid:133)  The  proposal/initiative  relates  to  a  new  action  following  a  pilot  project/preparatory 
action18 

(cid:133) The proposal/initiative relates to the extension of an existing action 

(cid:58) The proposal/initiative relates to an action redirected towards a new action 

1.4. 

Objectives 

1.4.1.  The  Commission’s  multiannual 

strategic  objective(s) 

targeted  by 

the 

proposal/initiative 

EDCTP2  will  contribute  to  the  Europe  2020  strategy  and  the  completion  of  the 
European Research Area, including the target of 3 % of the EU’s GDP to be invested 
in R&D, by developing a real partnership with developing countries to help eradicate 
poverty, promote growth and contribute to the Millennium Development Goals. 

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned 

EDCTP2  implementation:  EDCTP2  will  contribute  to  reducing  the  social  and 
economic  burden  of  poverty-related  diseases  (PRDs)  in  developing  countries,  in 
particular  in  sub-Saharan  Africa,  by  accelerating  the  clinical  development  of 
effective,  safe  and  affordable  medical  interventions  for  PRDs  in  partnership  with 
sub-Saharan Africa. 

ABM/ABB activity concerned: 08.02 Cooperation — Health 

17 
18 

ABM: Activity-Based Management — ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

EN 

24 

   EN 

                                                 
1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

1)  More  of  new  or  improved  medical  interventions  for  HIV/AIDS,  tuberculosis, 
malaria  and  other  poverty-related  diseases  for  the  benefit  of  developing  countries, 
and  by  the  end  of  the  programme  to  have  delivered  at  least  1  new  medical 
intervention;  to  have  issued  at  least  20  guidelines  for  improved  or  extended  use  of 
existing medical interventions; and to have progressed the clinical development of at 
least 10 candidate medical intervention. 
2)  Strengthened  cooperation  with  sub-Saharan  African  countries,  in  particular  on 
building their capacity for conducting clinical trials. 
3) Better coordination, alignment and integration of relevant national programmes to 
increase the cost-effectiveness of European public investment. 
4) Extended international cooperation with other public and private funders. 
5)  An  increased  impact  due  to  effective  cooperation  with  other  Union  initiatives, 
including EU development assistance. 

1.4.4. 

Indicators of results and impact 

Specify the indicators for monitoring implementation of the proposal/initiative. 

-  Number  of  clinical  trial  results  integrated  in  guidelines  or  recommendations  for 
improved clinical practice or submitted to regulators. 
-  Proportion  of  public  investments  of  participating  European  states  that  are 
integrated, aligned or coordinated through the EDCTP joint programme. 
- Number of African countries involved in EDCTP-funded projects. 
- Share of EDCTP-funded clinical trials with African leadership. 
-  Number  of  medical  interventions  proceeding  to  further  development  (through 
additional trials or next phase). 
- Number of joint peer-reviewed scientific articles. 
-  Number  of  African  researchers  supported  by  EDCTP  fellowships  staying  on  in 
Africa at least one year after the end of their training. 
- Number of clinical trials supported. 
-  Number  of  capacity-building  activities  supported  for  conducting  clinical  trials  in 
sub-Saharan Africa. 
- Number of fellowships to African researchers and MSc/PhD students. 
- Time-to-grant and Time-to-pay. 
- Volume and proportion of co-funding from the Union and the PSs, including funds 
raised by the PSs and the EDCTP from other public and private third parties. 
- Administrative costs. 

EN 

25 

   EN 

1.5. 

Grounds for the proposal/initiative 

1.5.1.  Requirement(s) to be met in the short or long term 

Despite the promising results of EDCTP1 and other international initiatives, there is 
still a lack of effective medical interventions for PRDs. The socio-economic burden 
of  these  diseases  remains  a  limiting  factor  for  the  sustainable  development  of 
developing  countries,  in  particular  in  sub-Saharan  Africa.  While  a  general 
improvement  in  factors  such  as  nutrition,  sanitation  and  infrastructure  is  certainly 
important,  the development  of new and better medical interventions is essential for 
an effective containment and long-term control of PRDs.  

intervention 

through  EDCTP2: 

that  require  Union 

The  persistent  lack  of  effective  medical  interventions  for  PRDs  is  affected  by  five 
key  drivers 
insufficient 
investment;  weak  clinical  research  capacity  in  sub-Saharan  African  countries; 
fragmented  public  support;  the  limited  scope  of  the  EDCTP1  programme;  and 
insufficient  links  to  other  EU  initiatives.  First  and  foremost,  the  medical 
interventions  needed  for  PRDs  will  not  be  developed  by  the  private  sector  alone 
owing  to  limited  financial  incentives  (market  failure).  Second,  clinical  trials  are  of 
such  scale  and  complexity  that  no  single  country  can  provide  the  necessary 
resources.  The  EU-level  approach  on  which  EDCTP  is  built  makes  it  possible  to 
achieve the necessary critical mass of resources, with Union funding complementing 
participating states’ contributions to EDCTP2.  

For  more  information,  please  read  the  impact  assessment  report  of  EDCTP2 
accompanying this legislative proposal. 

1.5.2.  Added value of EU involvement 

Public  intervention  at  EU  level  is  necessary  to  bring  together  compartmentalised 
national research programmes, help design common research and funding strategies 
across national borders and achieve the critical mass of actors and investment needed 
for  undertaking  resource-intensive  clinical  trials  of  new  medical  interventions  for 
poverty-related diseases in developing countries. In doing so, the impact of European 
activities and effectiveness of public investment in this field is maximised. In light of 
budgetary restrictions and from a purely economic perspective, it makes more sense 
than  ever  to  invest  collectively  in  order  to  maximise  the  cost-effectiveness  and 
impact.  Public  intervention  is  in  line  with  the  overall  provisions  of  the  EU  Treaty, 
related  EU  policies  and,  in  particular,  contributes  to  delivering  on  the  Union’s 
commitments  to  promote  aid  effectiveness,  inclusive  growth  and  progress  towards 
achieving the Millennium Development Goals. 

1.5.3.  Lessons learned from similar experiences in the past 

Up  until  now,  EDCTP  has  funded  241  projects  involving  185  African  and  70 
European research institutions. This includes 88 clinical trials which were all subject 
to  ethical  clearance  from  the  competent  national  ethics  board(s)  in  the  country  or 
countries in which the trial(s) were due to take place before any funding was granted 
by EDCTP. Most of the clinical trials supported by EDCTP were launched after 2007 
and  are  still  on-going.  Nevertheless,  they  have  already  generated  more  than  350 
scientific  publications  in  peer-reviewed  journals,  while  the  results  of  eight  clinical 
trials so far have been integrated in guidelines for improved clinical practice.  

EN 

26 

   EN 

Despite  these  achievements,  a  number  of  issues  were  raised  in  the  2009  interim 
evaluation report and the public consultation. These following issues are fundamental 
to the design and subsequent implementation of EDCTP2: 
- the current scope of EDCTP needs to be changed and extended; 
- the integration of European national programmes should be further improved; 
-  collaboration  with  other  major  public  and  private  funders,  including  the 
pharmaceutical industry, needs to be strengthened and extended; 
- synergies with European external policy actions should be developed, in particular 
with EU development assistance; 
- co-funding rules should be clarified and simplified; 
- monitoring tools need to be strengthened. 
For  more  information,  please  read  the  impact  assessment  report  of  EDCTP2 
accompanying this legislative proposal. 

1.5.4.  Compatibility and possible synergy with other appropriate instruments 

EDCTP was conceived to complement the actions implemented under the European 
Development  Fund  (EDF)  and  the  Development  Cooperation  Instrument  (DCI)  to 
ensure  the  development  and  delivery  of  medical  interventions  to  those  in  need.  So 
far,  interaction  with  these  European  programmes  for  development  assistance  has 
been  limited,  but  the  opportunity  remains  to  better  exploit  synergies  and  achieve 
greater impact of Union actions in research and development assistance. The remit of 
EDCTP  is  restricted  to  support  clinical  trials  and  corresponding  capacity-building. 
However,  in  resource-poor  settings  like  sub-Saharan  Africa,  such  activities  do  not 
exist in isolation, and would achieve a far greater impact if they were integrated in 
and coordinated with national healthcare systems and programmes. 

For  more  information,  please  read  the  impact  assessment  report  of  EDCTP2 
accompanying this legislative proposal. 

1.6. 

Duration and financial impact 

(cid:58) Proposal/initiative of limited duration 

–  (cid:58)  Proposal/initiative in effect from 1/1/2014 to 31/12/2024 

–  (cid:58)  Financial impact from 2014 to 2020 for commitment appropriations and from 

2014 to 2024 for payment appropriations 

(cid:133) Proposal/initiative of unlimited duration 

–  Implementation with a start-up period from YYYY to YYYY, 

–  followed by full-scale operation. 
1.7.  Management mode(s) envisaged19 

(cid:133) Centralised direct management by the Commission 

(cid:58)  Centralised  indirect  management  with  the  delegation  of  implementation  tasks 
to: 

–  (cid:133)  executive agencies 

19 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the 
BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html. 

EN 

27 

   EN 

                                                 
–  (cid:133)  bodies set up by the Communities20 

–  (cid:58)  national public-sector bodies/bodies with public-service mission 

–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title 
V of the Treaty on European Union and identified in the relevant basic act within 
the meaning of Article 49 of the Financial Regulation 

(cid:133) Shared management with the Member States 

(cid:133) Decentralised management with third countries 

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the ‘Comments’ section. 

Comments 

EDCTP2  shall  be  implemented  through  the  EDCTP  legal  entity  as  the  implementation 
structure (EDCTP2-IS). The current EDCTP legal entity was established by the 15 European 
founding countries as a European Economic Interest Group (EEIG) in the Netherlands. A new 
EDCTP legal entity will be established before the launch of the EDCTP2 Programme, based 
on organisational principles detailed in Annex III. 

2. 

MANAGEMENT MEASURES 

2.1.  Monitoring and reporting rules 

Specify frequency and conditions. 

Implementation  of  EDCTP2  will  be  monitored  through  annual  reports  covering  a 
single year N, which will be provided by the EDCTP-IS in year N+1. These annual 
reports will give a detailed overview of EDCTP2 activities in year N in comparison 
to the multiannual strategic work plan (covering year N to year N+2) and the annual 
work plan of year N. They will also provide detailed information on the performance 
and progress towards meeting EDCTP2 objectives and targets. These annual reports 
will also include updated figures on the indicators listed in section 1.4.4. 

An interim evaluation will be carried out with the assistance of independent external 
experts after three years of operation but not later than 31 December 2017. 

Before  the  end  of  EDCTP2  but  not  later  than  31  December  2023,  the  Commission 
will  conduct  another  interim  evaluation  with the  assistance  of  independent  external 
experts. 

A final independent ex-post evaluation after EDCTP2 has ended but not later than 31 
December  2026  will  be  conducted  by  an  independent  expert  panel  set  up  by  the 
Commission  and  tasked  with  reviewing  the  performance  and  quality  of  EDCTP2 
implementation and funded activities. 

2.2.  Management and control system 

2.2.1.  Risk(s) identified 

1) The main risk concerns the capacity of participating states to effectively integrate 
their  national  programmes  and  activities,  and  thus  deliver  their  contribution  to  the 
programme. 

20 

As referred to in Article 185 of the Financial Regulation. 

EN 

28 

   EN 

                                                 
2)  A  second  risk  concerns  effective  protection  against  fraud  and  possible  financial 
losses,  especially  due  to  weak  governance  and  financial  capacity  in  some  of  the 
developing countries and the corresponding beneficiaries of EDCTP2 grants. 

3) A third risk concerns the capacity of the implementation structure to manage the 
Unions  budget  contribution  and  monitor  the  national  activities  contributing  to  the 
programme. 

4)  A  fourth  risk  relates  to  the  high  costs,  long  duration,  ethical  clearance  and 
regulatory control required for clinical trials in humans, which can result in clinical 
trials  lasting  longer  than  initially  planned  and/or  being  more  costly.  This  is  often 
linked  to  delays  in  ethical  clearance  and/or  to  clinical  findings  that  require 
modification of clinical trials design. 

2.2.2.  Control method(s) envisaged 

The  Union’s  financial  interests  will  be  protected  through  proportionate  measures 
throughout  the  expenditure  life-cycle,  including  the  prevention,  detection  and 
investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly 
used and, where appropriate, penalties. 

Article 8 states that if EDCTP2 is not implemented or is implemented inadequately, 
partially or late, or if the Participating States do not contribute, contribute partially or 
late to the financing of EDCTP2, the Commission may reduce, withhold or terminate 
the European Union financial contribution. 

Articles 9 and 10 set out the EDCTP-IS' duty to guarantee a level of protection of the 
financial  interests  of  the  Union  and  makes  provision  for  access  to  information  and 
premises to control, evaluate and carry out audits on EDCTP2 implementation.  

2.2.3.  Costs and benefits of controls and probable non-compliance rate 

Article 9 provides for ex-post audits of expenditure on indirect actions to be carried 
out  in  accordance  with  the  Horizon  2020  Framework  Programme.  To  ensure 
consistency, the Commission may decide to carry out the audits referred to in herein. 

2.3.  Measures to prevent fraud and irregularities 

Specify existing or envisaged prevention and protection measures. 

Article  10  sets  out  that  the  EDCTP-IS  has  to  grant  access  to  information  and 
premises necessary for the Commission to control, evaluate and carry out audits on 
EDCTP2 implementation or for OLAF to carry out investigations. 

EN 

29 

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3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected 

•  Existing budget lines 

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework  Heading  la  -  Competitiveness  for  growth  and 

Budget line 

jobs 

Type of  
expenditure

Diff./non-
diff. 
(21) 

Contribution  

from 
EFTA 
countries
22 

from 
candidate 
countries23 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

Administrative Expenditures 

NDA 

YES 

YES 

YES 

YES 

08.01.05.03 Other management 
expenditure for Research 

Operational Expenditures 

DA 

YES 

YES 

YES 

YES 

Societal challenges 

08.02.03.01 Improving lifelong health and 
wellbeing 

•  New budget lines requested 

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework  Heading  la  -  Competitiveness  for  growth  and 

Budget line 

jobs 

Type of 
expenditure

Diff./non-
diff. 

Contribution  

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

Administrative Expenditures 

NDA 

YES 

YES 

YES 

YES 

08.01.05.03 Other management 
expenditure for Research 

Operational Expenditures 

DA 

YES 

YES 

YES 

YES 

Societal challenges 

08.02.03.01 Improving lifelong health and 
wellbeing 

21 
22 
23 

Diff. = Differentiated appropriations / Non-Diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association. . 
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

30 

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3.2. 

Estimated impact on expenditure 

3.2.1. 

Summary of estimated impact on expenditure 

Heading of multiannual financial framework: 

1A 

Heading la - Competitiveness for growth and jobs 

EUR million (to three decimal places) 

DG: RTD 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

Years 
2021-
2024 

(cid:121) Operational appropriations  

08.02.03.01 

Commitments
Payments 

(1) 

(2) 

25,000 
4,000 

55,000 
20,000 

80,000 
50,000 

110,000 
110,000 

110,000 
110,000 

110,000 
130,000 

193,000 
130,000 

0,000 
129,000 

683,000 
683,000 

(cid:121) Appropriations of an administrative nature financed from the 
envelope of specific programmes24  
08.01.05.03 

(3) 

0,297 

0,303 

0,309 

0,315 

0,321 

0,328 

0,334 

0,000 

2,207 

TOTAL appropriations  
under HEADING 1A 
of the multiannual financial framework 

Commitments

=4+6 

25,297 

55,303 

80,309 

110,315 

110,321 

110,328 

193,334 

0,000 

685,207 

Payments 

=5+6 

4,297 

20,303 

50,309 

110,315 

110,321 

130,328 

130,334 

129,000 

685,207 

24

EN 

Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research. 

31 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
Heading of multiannual financial  
framework  

1A 

Heading la - Competitiveness for growth and jobs ‘Administrative expenditure’ 

DG: RTD 

(cid:121) Human resources 
(cid:121) Other administrative expenditure  

TOTAL DG RTD 

TOTAL appropriations 
for HEADING 1A 
of the multiannual financial framework  

(Total 
commitments  = 
Total payments) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial 
framework  

Commitments 

Payments 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Years 
2021-
2024 

TOTAL 

EUR million (to three decimal places) 

0,297 

0,000 

0,303 

0,000 

0,309 

0,000 

0,315 

0,321 

0,000 

0,000 

0,328 

0,000 

0,334 

0,000 

0,000 

0,000 

2,207 

0,000 

0,297 

0,303 

0,309 

0,315 

0,321 

0,328 

0,334 

0,000 

2,207 

0,297 

0,303 

0,309 

0,315 

0,321 

0,328 

0,334 

0,000 

2,207 

EUR million (to three decimal places) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

Years 
2021-
2024 

TOTAL 

25,297 

55,303 

80,309 

110,315 

110,321 

110,328 

193,334 

0,000 

685,207 

4,297 

20,303 

50,309 

110,315 

110,321 

130,328 

130,334 

129,000 

685,207 

EN 

32 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations 

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations 

–  (cid:58)  The proposal/initiative requires the use of operational appropriations, as explained below: 

Commitment appropriations in EUR million (to three decimal places) 

Indicate 
objective
s and 
outputs * 

(cid:216) 

Type25 

Aver
r
e
age 
b
m
cost 
u
**  N

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

OUTPUTS 

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

r
e
b
m
u
N

Cost 

l
a
t
o
T

r
e
b
m
u
N

Total Cost 

SPECIFIC OBJECTIVE No 1  

EDCTP2 implementation 

- Output 

R&D activity 

1,442 

87  126,060

104

149,826

116

166,798

135

194,999 

131

188,759

129

186,695

198

284,923

900

1.298,060 

- Output 

Subtotal for specific objective No 1 

TOTAL COST 

87  126,060

104

149,826

116

166,798

135

194,999 

131

188,759

129

186,695

198

284,923

900

1.298,060 

* Provided that the PS contribution is increased by at least 15% through new Participating Countries joining EDCTP2 as provided in Article 2.1, such that the total value of 
the EDCTP2 programme is at least EUR1.366,379 million, including up to 5% (EUR 68,319 million) for administrative costs, with an EU contribution of EUR 683,000 
million (out of which 6% equal to EUR 41 million for administrative costs). 

** An average cost per R&D activity was calculated on the basis of the operational targets for the minimum number of specific R&D activities to be supported by the 
EDCTP2 programme and estimated average costs per specific R&D activity: 150 clinical trials (€7,254 million); 600 fellowships ( €0,200 million); 150 capacity strengthening 
activities (€0,600 million) 

25 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 

EN 

33 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary 

–  (cid:133)  The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature 

–  (cid:58)  The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below: 

EUR million (to three decimal places) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

TOTAL 

HEADING 5A 
of the multiannual 
financial framework 

Outside 
HEADING 5A of the 
multiannual financial 
framework  

Human resources  

0,297 

0,303 

0,309 

0,315 

0,321 

0,328 

0,334 

2,207 

expenditure  
Other 
of  an  administrative 
nature 

Subtotal  
outside HEADING 
5A 
of the multiannual 
financial framework  

0,297 

0,303 

0,309 

0,315 

0,321 

0,328 

0,334 

2,207 

TOTAL 

0,297 

0,303 

0,309 

0,315 

0,321 

0,328 

0,334 

2,207 

The  administrative  appropriations  required  will  be  met  by  the  appropriations  of  the  DG  which  are  already  assigned  to 
management  of  the  action  and/or  which  have  been  redeployed  within  the  DG,  together  if  necessary  with  any  additional 
allocation  which  may  be  granted  to  the  managing  DG  under  the  annual  allocation  procedure  and  in  the  light  of budgetary 
constraints.

EN 

34 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.2.  Estimated requirements of human resources 

–  (cid:133)  The proposal/initiative does not require the use of human resources. 

–  (cid:58)  The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below:26 

Estimate to be expressed in full time equivalent units 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
2020 

(cid:121) Establishment plan posts (officials and temporary agents) 

08 01 01 01 (Headquarters and Commission’s 
Representation Offices) 
08 01 01 02 (Delegations) 
08 01 05 01 (Indirect research) 
10 01 05 01 (Direct research) 

2 

2 

2 

2 

2 

2 

2 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)27 

XX 01 02 01 (CA, INT, SNE from the ‘global 
envelope’) 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 
XX 01 04 yy28 

- at headquarters 

- in delegations  

08 01 05 02 (CA, SNE, INT — Indirect 
research) 

10 01 05 02 (CA, SNE, INT — Direct 
research) 
Other budget lines (specify) 
TOTAL 

0.5 

0.5 

0.5 

0.5 

0.5 

0.5 

0.5 

2.5 

2.5 

2.5 

2.5 

2.5 

2.5 

2.5 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to management of the 
action  and/or  have  been  redeployed  within  the  DG,  together  if  necessary  with  any  additional  allocation  which 
may  be  granted  to  the  managing  DG  under  the  annual  allocation  procedure  and  in  the  light  of  budgetary 
constraints. 

Description of tasks to be carried out: 

Officials 
temporary staff 

and 

External staff 

Participation in EDCTP General Assembly: 2 two-day meetings/year (Director, Head of 
Unit). 
Participation in EDCTP Scientific Advisory Committee: 2 two-day meetings/year (Head 
of Unit, project officer). 
Participation  in  stakeholder  consultation  and  information  events:  8  events  per  year 
(Head of Unit, project officer). 
Negotiation,  preparation  and  payment  of  delegation  agreement  with  the  EDCTP-IS 
(project officer, financial officer, administrative assistant). 
Monitoring of EDCTP2, assistance to interim/final evaluations (project officer). 
Financial and legal auditing of EDCTP2 (financial officer). 
Monitoring of EDCTP2, assistance to interim/final evaluations (contract agent) 

26 
27 

28 

Staff needed after 2020 for follow-up of EDCTP2 implementation will be determined at a later stage. 
CA=  Contract  Agent;  LA  =  Local  Agent;  SNE  =  Seconded  National  Expert;  INT  =  agency  staff 
(‘Intérimaire’); JED= ‘Jeune Expert en Délégation’ (Young Experts in Delegations). 
Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 

EN 

35 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.4.  Compatibility with the current multiannual financial framework 

–  (cid:58)  Proposal/initiative  is  compatible  with  the  current  multiannual  financial 

framework. 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision 

of the multiannual financial framework29. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 

3.2.5.  Third-party contributions 

–  The proposal/initiative does not provide for co-financing by third parties. 

–  (cid:58)The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to three decimal places) 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

Total 

of 

Commitments 
EDCTP2 
Participating  States* 
as listed in Article 1  

Commitments  of  any 
other  Member  State 
or  any  other  country 
associated to Horizon 
2020 
the 
joining 
EDCTP2 Programme 
in  accordance  with 
Article 2 

TOTAL 
appropriations  co-
financed  

106,833 

102,216 

77,616 

77,616 

71,116 

68.966 

90,016 

594,379 

0,000 

0,000 

17,800 

17,800 

17,800 

17,800 

17,800 

89,000 

106,833 

102,216 

95,416 

95,416 

88,916 

86,766 

107,816 

683,379 

*  EDCTP2  Participating  States'  (PS)  commitments  as  endorsed  by  the  EDCTP  General  Assembly  of  PS 
2013. 
representatives 
Accordingly, 
an  updated  EDCTP2  Strategic  Business  Plan  will  be  published  by  EDCTP: 
http://www.edctp.org/Towards_EDCTP2.799.0.html 

communicated 

Commission 

June 

and 

the 

to 

in 

Co-Financing details: 
The Participating States' contributions shall be at least equal to the EU contribution. The EU 
contribution shall in any case not exceed EUR 683,000 million. 
Up to 5% of the total value of the EDCTP2 programme will be for administrative costs of the 
EDCTP2-IS,  up  to  a  maximum  of  EUR  68,319  million.  The  maximum  EU  contribution  to 
these  administrative  costs  will  be  up  to  6%  of  the  EU  contribution  to  EDCTP2,  thus  not 
exceeding EUR 41,000 million. 

29 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

36 

   EN