Commission staff working document - European research and knowledge for global health Accompanying document to the Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions - The EU Role in Global Health {COM(2010) 128} {SEC(2010) 380} {SEC(2010) 382}
Date: 2010-03-31
Institutions: European Commission
Subjects: EU policy, developing countries, development policy, equal treatment, health policy, international affairs, medical research, public health, right to health

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EUROPEAN COMMISSION 

Brussels, 31.3.2010 
SEC(2010) 381 final 

COMMISSION STAFF WORKING DOCUMENT 

European research and knowledge for global health 

Accompanying document to the 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE 
EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

The EU Role in Global Health 

{COM(2010) 128} 
{SEC(2010) 380} 
{SEC(2010) 382} 

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COMMISSION STAFF WORKING DOCUMENT 

European research and knowledge for global health 

Contents 

1. 

2. 

Introduction .................................................................................................................. 3 

Context ......................................................................................................................... 3 

2.1. 

Knowledge as a public good for health........................................................................ 4 

2.1.1.  Global public goods for health..................................................................................... 4 

2.2. 

Global Strategy and Plan of Action on Public Health, Innovation and Intellectual 
Property ........................................................................................................................ 5 

2.3. 

EU Framework Programme ......................................................................................... 5 

3. 

Action to make the impact of research more equitable................................................ 7 

3.1. 

Joint agenda and priority-setting for global health research ........................................ 7 

3.1.1.  EU level........................................................................................................................ 7 

3.1.2.  Global level .................................................................................................................. 8 

3.2. 

Better generation of knowledge relevant to global health ........................................... 9 

3.2.1.  Better regulation; building on the experience with orphan drugs .............................. 10 

3.2.2.  Direct subsidies for research to improve global health equity................................... 10 

Research supported under the EU Framework Programme ..................................................... 11 

Other innovative means of financing ....................................................................................... 17 

3.3. 

Equitable access to knowledge and implementation of results.................................. 17 

3.3.1.  Open access................................................................................................................ 18 

3.3.2.  Local capacity ............................................................................................................ 18 

3.3.3.  Translation of knowledge into clinical care provision (implementation research).... 19 

3.3.4.  Translation of knowledge into policies (health services research) ............................ 19 

4. 

Conclusions ................................................................................................................ 20 

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Introduction 
This paper, accompanying the Communication on the EU Role in Global Health,1 describes 
the  valuable  input  that  research  can  offer  for  improving  global  health.  The  factors  enabling 
and impeding innovation targeted on health for all are described along with the EU’s current 
role and position. Overall, the aim is to outline how the EU could contribute to strengthening 
the  knowledge  base  on  public  health  and  to  technological  improvements  to  support 
development of health services around the world that are based on the shared European values 
of universality, access to good-quality care, equity and solidarity. 

1.  Context 

Innovation  in  health  sciences  has  made  a  major  contribution  to  improving  longevity  and 
quality  of  life  in  Europe  and  beyond.  However,  innovation  can  only  make  a  meaningful 
contribution to public health if it can be put to the benefit of the entire population. It is not 
enough for new treatments or medical products to be effective and safe. They also have to be 
acceptable,  affordable  and  accessible.  Access  issues  therefore  need  to  be  built  into  the 
research process at an early stage. 

Knowledge  can  generally  be  considered  a  ‘public  good’  that  is  underprovided  in  perfect 
markets  as  there  is  no  direct  link  between  the  costs  of  production  and  the  benefits  of 
consumption. In order to benefit fully from medical research, public intervention is necessary. 
This can take the form either of public subsidies for research (e.g. grants) or of a regulatory 
framework that allows the private sector to reap the benefits of its research and development 
efforts with the aid of exclusive marketing rights (e.g. intellectual property rights — IPR). 

Under its Research Framework Programmes, the EU has been supporting research across the 
entire  innovation  cycle:  from  the  discovery  of  potential  healthcare  products  using  basic 
research, development of new products by means of pre-clinical and clinical research and the 
delivery  of  new  products  and  treatments  as  a  result  of  public  health  and  health  services 
research. 

The  European  Commission  views  IPR  as  a  key  element  in  promoting  innovation  and 
underlines  the  need  for  high-quality  patents  granted  by  efficient  and  affordable  procedures 
and  giving  all  stakeholders  the  legal  certainty  they  need.2  However,  gaps  in  the  innovation 
process  have  emerged.  First,  despite  increasing  investment  in  research  and  development 
(R&D),  pharmaceutical  companies  are  not  refilling  the  product  pipeline  effectively. 
Consequently, the number of novel medicines reaching the market is decreasing. Second, IPR 
provide big incentives to develop  new  medicines  and  medical  technologies. However, these 
incentives are much less effective when patients are either too few or too poor. Third, there is 
an enormous gap between what is available and known to maximise the quality of healthcare 
and what is being delivered in practice. 

It is therefore essential that:  

• 

research  priorities  are  geared  to  making  the  biggest  impact  on  public  health  (see 
section 2.1); 

1 
2 

COM(2010) xxx of xx.xx.2010. 
Commission Communication ‘Enhancing the patent system in Europe’, COM(2007) 165 final. 

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•  public  research  funding  and  regulation  of  medical  innovations  are  coherent  and  aligned 

with those priorities (see section 2.2); 

• 

the  needs  of  the  populations  currently  underserved  by  medical  innovation,  the  poor  and 
those with rare diseases or conditions are adequately addressed (see section 3). 

1.1. Knowledge as a public good for health 

Economic input in human well-being is classified as either a public or a private good. Most 
goods  are  private  in  nature.  They  cannot  be  consumed  again  (they  are  rival)  and  their 
consumption can be withheld until payment is made (they are excludable). Private goods are 
best provided by the market mechanisms of supply and demand. By contrast, public goods are 
not  diminished  by  use  (non-rival)  and  are  available  to  all  (non-excludable).  A  classical 
example is a lighthouse, whose benefits are available to all ships all the time. Public goods are 
underprovided in free markets, as there is no natural incentive to produce them. Therefore the 
state  has  a  role  to  play  in  order  to  secure  the  collectively  optimum  level  of  public  goods, 
either by providing them directly or by ensuring that they are produced by private companies. 
That  is  not  to  say  that  no  knowledge  would  be  produced  without  intervention  by  the  state. 
However, there would be much less. 

Knowledge is considered a public good, even if it is embodied in a tangible good (e.g. a drug). 
Public policy is therefore crucial to ensure that knowledge is acquired, either by subsidising 
research  directly  (see  section  2.2.2)  or  by  providing  effective  incentives  for  private 
engagement  in  research  (see  section  2.2.1).  The  forms  of  incentive  and  amount  of  direct 
subsidies differ widely from country to country, even within the European Union. However, 
increasing  attention  has  been  being  paid  to  intervention  at  European  and  global  level  to 
coordinate and optimise generation of knowledge relevant to health for all. 

1.1.1.  Global public goods for health 

The concept of ‘global public good’ (GPG) is an extension of the economic theory described 
above.  GPG  is  defined  as  ‘a  good  which  it  is  rational,  from  the  perspective  of  a  group  of 
nations  collectively,  to  produce  for  universal  consumption,  and  for  which  it  is  irrational  to 
exclude an individual nation from consuming, irrespective of whether that nation contributes 
to its financing’.3 The concept is limited to collective action at global level that is (also) in the 
donor countries’ self-interest. Even though the concept calls for ‘collective action’, this does 
not mean that all collective action that is worthwhile actually produces a GPG. The main issue 
raised  by  provision  of  public  goods  at  global  level  is  how  to  manage  collective  action 
effectively in the absence of a ‘government’ that could provide or finance the public goods.4 
Control  (possibly  eradication)  of  communicable  diseases  is  one  clear  example  of  a  GPG.  It 
would  benefit  everyone,  in  poorer  and  richer  countries  alike  and  in  present  and  future 
generations. Industrialised countries cannot provide the GPG ‘communicable disease control’ 
by policy measures of their own but depend on the cooperation of countries around the world. 
This became apparent in the recent H1N1 pandemic. Since successful cooperation depends on 

3 

4 

Woodward, D., Smith, R.D.: ‘Global Public Goods for Health: concepts and issues’. In ‘Global Public 
Goods for Health: a health economic and public health perspective’, Chapter 1, edited by Smith, R.D., 
Beaglehole, R., Woodward, D. and Drager, N., Oxford University Press, 2003. 
Sandler,  T:  ‘Global  and  Regional  Public  Goods:  A  Prognosis  for  Collective  Action’,  Fiscal  Studies 
1998, 19:221-247. 

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sharing  the  costs  and  net  benefits  fairly,  such  global  collaboration  could  improve  health 
equity.5 

Research  and  development  to  generate  medical  knowledge  is  another  example  of  a  public 
good  that  is  inherently  global  in  nature.  Medical  knowledge  includes  diagnosis,  prevention 
and  cure  of  diseases,  understanding  health  risks  and  the  effectiveness  of  health  delivery 
systems and traditional medicine. However, the end-use of knowledge, particularly when it is 
embodied  in  a  product  or  service,  is  predominantly  excludable  and  rival  and,  therefore,  a 
private good. The GPG aspects of R&D and the fact that they are lacking in fields that would 
benefit poor countries call for collective action at global level in this area.6 

1.2. Global  Strategy  and  Plan  of  Action  on  Public  Health,  Innovation  and 

Intellectual Property 

The debate on the contribution that innovation in public health can make to improving human 
health  in  developing  countries  led  to  establishment  of  the  Commission  on  Intellectual 
Property  Rights,  Innovation  and  Public  Health  by  the  World  Health  Assembly  (WHA)  in 
2003.7 This Commission concluded that IPR provide big incentives to develop new medicines 
and medical technologies. However, those rights are not an effective incentive when patients 
are either too few (e.g. sufferers of rare diseases) or too poor. New approaches to incentives, 
financial  mechanisms  and  coordination  of  stakeholders  are  necessary  to  address  the  very 
different issues when either no product exists to address specific health needs of the poor or 
existing medical products are not accessible and affordable for poor communities. The WHA 
adopted Resolution WHA 59.24 on Public Health, Innovation, Essential Health Research and 
IPR:  Towards  a  Global  Strategy  and  Plan  of  Action.  Among  other  proposals,  the  resolution 
requested the Director-General of the World Health Organisation (WHO) to establish an inter-
governmental  working  group  open  to  all  interested  Member  States  to  develop  a  global 
strategy and plan of action with the aim, inter alia, of securing an enhanced and sustainable 
basis  for  needs-driven,  essential  health  research  and  development  relevant  to  diseases  that 
disproportionately  affect  developing  countries,  proposing  clear  objectives  and  priorities  for 
research  and  development  and  estimating  funding  needs  in  this  area.  After  extensive  and 
lengthy discussions and negotiations in the Intergovernmental Group, the WHA adopted the 
Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property in 
2008.8  This  strategy  is  designed  to  promote  a  new  approach  to  innovation  and  access  to 
medicines which would encourage needs-driven rather than market-driven research to target 
diseases that disproportionately affect people in developing countries. 

1.3. EU Framework Programme 

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6 

7 

8 

Kaul,  I.  and  Faust,  M.:  ‘Global  public  goods  and  health:  taking  the  agenda  forward’,  Bulletin  of  the 
World Health Organisation, 2001, 79: 869–874. 
Smith, R.D. and MacKellar, L.: ‘Global public goods and the global health agenda: problems, priorities 
and potential’, Globalisation and Health, 2007, 3:9. 
Resolution WHA56.27: Increasing Access to Essential Medicines, fifty-sixth World Health Assembly, 
Geneva, 19–28 May 2003, World Health Organisation. 
Resolution  WHA61.21:  Global  Strategy  and  Plan  of  Action  on  Public  Health,  Innovation  and 
Intellectual  Property,  sixty-first  World  Health  Assembly,  Geneva,  19–24  May  2008,  World  Health 
Organisation. 

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The  main  instrument  for  implementing  the  EU’s  research  policy  is  the  Framework 
Programme  of  the  European  Community  for  research,  technological  development  and 
demonstration  activities.  The  EU  has  been  financing  research  on  the  basis  of  multiannual 
Framework Programmes since 1984. The current Seventh Framework Programme (FP7) runs 
from  2007  to  2013.9  Within  FP7  the  specific  programme  with  the  highest  budget  is 
 32.413 billion  for  2007-2013),  which  supports  health  research  (the  Health 
‘Cooperation’  (€
Theme  has  a  budget  of  €
 450 million, 
which  is  relatively  small  when  compared  with  the  actual  needs  and  the  level  of  funding 
provided by other public or private international funding agencies). 

 6.1 billion,  the  ICT  (eHealth)  Theme  an  additional  €

The  objective  of  FP7  is  to  strengthen  industrial  competitiveness  and  to  meet  the  research 
needs  of  other  Community  policies,  including  health,  thereby  contributing  to  creating  a 
knowledge-based  society,  building  on  a  European  Research  Area  and  complementing 
activities at national and regional levels. It promotes excellence in scientific and technological 
research, development and demonstration activities. 
The  specific  programme  on  ‘Cooperation’10  provides  support  for  transnational  cooperation 
across  the  European  Union  and  beyond  to  address  social,  economic,  public  health, 
environmental and industrial challenges. The overarching aim is to contribute to sustainable 
development in the context of promoting research, the primary purpose of which is to increase 
knowledge at the highest level of excellence. 

International  cooperation  offering  European  added-value  and  of  mutual  interest  supports  an 
international science and technology (S&T) policy that has two interdependent objectives: 

–  to  support  and  promote  European  competitiveness  by  means  of  strategic  research 
partnerships with non-EU countries, including highly industrialised and emerging economies, 
by engaging the best scientists to work in and with Europe; and  

– to address specific problems that non-EU countries face or of a global nature, on the basis of 
mutual interest and mutual benefit. 

International cooperation is implemented in each thematic area and across themes by means 
of: 

•  Greater  participation  by  researchers  and  research  institutions  from  all  countries,  with 
particular  emphasis  on  encouraging  non-EU  participation  in  identified  areas  of  mutual 
interest. 

• Specific cooperation targeted on non-EU countries in cases of mutual interest in cooperating 
on particular topics selected on the basis of their scientific and technological level and needs. 
Identification of specific needs and priorities is closely linked to relevant bilateral cooperation 
agreements  and  ongoing  multilateral  and  bi-regional  dialogues  between  the  EU  and  these 
countries  or  groups  of  countries.  Priorities  are  based  on  the  particular  needs,  potential  and 
level  of  economic  development  in  the  region  or  country.  To  this  end,  a  Strategic  European 
Framework for International Science and Technology Cooperation11 has been developed with 

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11 

Decision  No  1982/2006/EC  of  the  European  Parliament  and  of  the  Council  of  18  December  2006 
concerning the Seventh Framework Programme of the European Community for research, technological 
development and demonstration activities (2007-2013). 
Council Decision 2006/971/EC of 19 December 2006 concerning the specific programme ‘Cooperation’ 
implementing  the  Seventh  Framework  Programme  of  the  European  Community  for  research, 
technological development and demonstration activities (2007 to 2013). 
Communication  from  the  Commission  to  the  Council  and  the  European  Parliament,  COM(2008)  588 
final of 4 September 2008. 

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the main objective of contributing to global sustainable development and fostering Europe’s 
scientific and technological excellence.  

This  framework  aims  to  contribute  to  the  free  circulation  of  knowledge  —  ‘the  EU’s  fifth 
freedom’  —  at  global  level.  More  specifically,  it  is  designed  to:  strengthen  coordination  of 
Member States’ and EU-funded action with the aim of reinforcing strategic S&T cooperation 
and  information  society  dialogues  with  partners  worldwide;  generate  additional  synergies 
between public authorities, industry and civil society to make EU action in these policy fields 
more  efficient;  facilitate  access  to  knowledge,  resources  and  markets  worldwide;  have  a 
positive influence on the global science and technology agenda by pooling resources to build 
up  critical  mass  and  by  underlining  democratic  values  in  the  global  information  society,  in 
particular  freedom  of  expression  and  the  right  of  access  to  information;  improve  the 
conditions under which international research is conducted and promote the European model 
of  convergence  to  make  information  society  policies  more  effective;  make  it  easier  for 
Europe’s  researchers  and  universities  to  work  with  the  best  scientists  and  research 
infrastructure  in  the  world;  and  strengthen  the  global  position  of  European  industry  in 
electronic communications and other advanced technologies. 

2.  Action to make the impact of research more equitable 

2.1. Joint agenda and priority-setting for global health research 

In  the  last  two  decades,  resources  for  health  research  and  innovation  have  increased 
 160  billion  per  year 
considerably  —  more  than  five-fold  since  1986  to  more  than  €
worldwide12  —  coinciding  with  increasing  interest  shown  by  new  players  (philanthropists, 
public-private  partnerships  and  product  development  partnerships13).  The  private  for-profit 
sector  accounts  for  51 %  of  this  amount,  the  public  sector  for  41 %  and  the  private  not-for-
profit  sector  for  8 %.  These  positive  developments  have  led  to  diversification  but  also 
fragmentation of research funding, raising the issues of critical mass, thematic overlap and the 
accountability  and  transparency  of  the  individual  bodies  and  organisations  funding  research 
relevant to global health. 

2.1.1.  EU level 

The EU has adopted a common vision for the European Research Area in 2020.14 The aim is 
to  create  strong  added  value  by  fostering  healthy  Europe-wide  scientific  competition  while 
ensuring  the  appropriate  level  of  cooperation  and  coordination.  Research  priorities  are 
identified and agreed within the EU in the light of the Framework Programmes, the basis on 
which all research-related EU action is financed. Most of the research funding is managed by 
adopting annual work programmes (WP). Each WP is drafted by the Commission, based on 
the  research  priorities  of  all  its  departments  dealing  with  health  and  input  from  an  advisory 
board of about 20 outstanding scientists in the field. Each WP has to be discussed and agreed 
by  the  Programme  Committee  that  brings  together  representatives  from  every  EU  Member 

12 

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14 

Global Forum for Health Research: ‘Monitoring financial flows for health research 2008’, Washington 
DC, 2009. 
In May 2009, the Commission ‘Progress report on the implementation of the European Programme for 
Action  to  Confront  HIV/AIDS,  Malaria  and  Tuberculosis  through  External  Action  (2007-2011)’ 
reaffirmed the pivotal role played by product development partnerships (SEC(2009) 748 final). 
Council conclusions on a ‘2020 Vision for the European Research Area’, 2 December 2008. 

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State (and 10 non-EU countries), most of which are represented by the ministry responsible 
for research. This coordination is a formal and lengthy process but can take into account the 
views of various stakeholders (policy-makers, health professionals, scientists, patients, etc.) at 
both European and national levels.  

For international coordination of research beyond Europe, a range of different mechanisms for 
consultations  and  joint  priority-setting  have  evolved  under  the  Framework  Programmes.  In 
FP6,  regional  dialogue  mainly  took  the  form  of  joint  coordination  schemes,  such  as  the 
Common Area of Higher Education for countries in the European Union, Latin America and 
the Caribbean region (ALCUE). Specific action was initiated with countries that have bilateral 
science  and  technology  agreements  with  the  Commission.  In  FP7  these  arrangements  have 
developed into INCO-Nets15 at regional level and BILAT16 action at bilateral level wherever 
there is a science and technology agreement. These fora cover a broad range of themes and 
are  complemented  by  more  theme-specific  coordination  on  ‘Health’  topics,  for  example  on 
migrant health, poverty-related diseases and capacity-building for health research. 

The  ‘Health’  theme  of  the  specific  programme  on  ‘Cooperation’  under  FP7  provides  a 
mandate  for  international  cooperation  in  the  context  of  the  millennium  development  goals. 
Priority  areas,  formulated  by  bi-regional  dialogues  in  non-EU  countries,  regions  and 
international  fora  and  adapted  to  local  needs  or  with  the  aid  of  partnerships,  include  health 
policy  research,  health  systems  and  healthcare  service  research,  maternal  and  child  health, 
reproductive  health,  control  and  surveillance  of  neglected  communicable  diseases  and 
emerging unforeseen policy needs in the regions concerned. In a two-way process combining 
active participation in major conferences discussing the global agenda for research on health 
(such as the Global Forum and Ministerial Summits (Mexico 2004 and Bamako 2008)) with 
specific  scientific  conferences  (for  example,  the  biannual  Congresses  on  Tropical  Medicine 
and  International  Health  last  held  in  Verona,  Italy,  in  September  2009),  the  Commission  is 
contributing to further development of this agenda in the light of the FP, taking up new ideas 
and approaches in the work programmes for FP7. 

2.1.2.  Global level 

The  Commission  is  promoting  and  operating  within  international  frameworks  for  dialogue 
and agenda-setting based on its concepts of mutual benefit, equitable partnership and global 
agreements, such as the millennium development goals. Most prominently, the Commission is 
closely  engaged  with  the  WHO  and  its  aligned  programmes,  such  as  the  Tropical  Disease 
Research Programme, the World Alliance for Patient Safety and the annual conferences of the 
Global Forum for Health Research. 

World Health Organisation 

The Commission interacts with the WHO in several ways on health research. It sits in as an 
observer at meetings of the Advisory Committee for Health Research (ACHR) set up in 1959 
to support the WHO in its constitutional role of promoting and coordinating research relating 

15 

16 

The purpose of an INCO-NET is to bring policy-makers and stakeholders from a given region or group 
of countries together with the EU partners to establish a dialogue to identify S&T priorities of mutual 
benefit and interest, define the broad lines of cooperation policy and take specific action to promote and 
contribute to participation by the targeted regions or countries in the Framework Programme. 
BILAT projects support coordination to enhance and develop S&T partnerships. They are restricted to 
non-EU countries which have signed, or are in the process of signing, an S&T cooperation agreement 
with the EC. 

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to  international  health  work,  acting  in  close  cooperation  with  external  institutions  pursing 
common  goals  and  with  the  scientific  community  at  large.  The  WHO  Regional  Office  for 
Europe also has an Advisory Committee for Health Research, in which the Commission has 
likewise participated as an observer. The Commission is also represented on the WHO World 
Alliance for Patient Safety Research Council, whose aim is to facilitate research into patient 
safety and encourage the spread of research results throughout healthcare systems globally, by 
contributing  to  building  up  the  evidence  necessary  for  developing  new  solutions  and  for 
applying known solutions to patient safety more effectively. Furthermore, in a more strategic 
context,  the  Commission  participated  in  a  high-level  consultation  launched  by  Director-
General Chan in June 2008 on ‘scaling up research and learning for health’.   

  Global Strategy and Plan of Action 

In  its  capacity  as  a  regional  economic  integration  organisation,  the  Commission  has  also 
played a proactive and constructive role in the work of the Intergovernmental Working Group 
on  Public  Health,  Innovation  and  Intellectual  Property  Rights.  In  this  connection,  the 
European  Commission  and  the  WHO  have  signed  agreements  on  preparatory  action  with  a 
view to implementing elements 3 and 4 of the Global Strategy and Plan of Action.17,18 These 
agreements were made possible by preparatory action adopted by the European Parliament in 
2008 and 2009 in response to the concern in the domains of research and development about 
poverty-related,  tropical  and  neglected  diseases  and  improving  access  to  medicines  in 
developing countries by pharmaceutical-related technology transfers and local production. 

At the same time, the Commission coordinates with other major funders of health research at 
global  level,  such  as  the  Heads  of  International  Research  Organisations  (HIROs),  the  Gates 
Foundation,  the  National  Institutes  of  Health  (NIH)  and  the  Wellcome  Trust,  in  order  to 
increase  synergies  and  complementarity.  Building  on  its  rich  experience  on  agenda-  and 
priority-setting with international partner countries, the Commission supports moves by low- 
and middle-income countries to identify opportunities for research under FP7.  

2.2. Better generation of knowledge relevant to global health 

Research  and  development  needs  and  contexts  should  be  based  on  the  priorities  identified 
above.  It  is  therefore  necessary  to  align  the  incentives  and  public  subsidies  for  meaningful 
research on these priorities.  

It  is  beyond  the  scope  of  this  document  to  enter  into  a  detailed  discussion  of  how  the 
regulatory  framework  for  pharmaceutical  innovation  can  help  to  address  the  challenge  of 
pharmaceutical  companies  refilling  the  product  pipeline,  particularly  as,  despite  increasing 
investment  in  R&D,  the  number  of  novel  medicines  reaching  the  market  has  been 
decreasing.19 Instead, it will concentrate on how global health equity can be achieved, so that 
populations underserved by scientific progress can benefit in an equitable way.  

17 

18 

19 

Decision  C(2008)  8124  of  15  December  2008  approving  the  financing  of  a  pilot  project  and  two 
preparatory actions in the field of human and social development under budget items 21 05 01 05, 21 05 
01 06 and 21 05 01 07 of the general budget of the European Communities. 
Decision C(2009) 10024 of 18 December 2009 approving the financing of two preparatory actions in 
the  field  of  human  and  social  development  under  budget  items  21  05  01  06  and  21  05  01  07  of  the 
general budget of the European Union. 
Communication  from  the  Commission:  Executive  Summary  of  the  Pharmaceutical  Sector  Inquiry 
Report, COM(2009) 351 of 8 July 2009. 

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2.2.1.  Better regulation; building on the experience with orphan drugs  

Rare  diseases  are  diseases  with  particularly  low  prevalence.  The  European  Union  considers 
diseases rare when they affect not more than 5 per 10 000 persons. Between 5 000 and 8 000 
distinct  rare  diseases  have  been  identified  today,  affecting  between  6 %  and  8 %  of  the 
population  in  the  course  of  their  lives.  In  other  words,  although  the  prevalence  of  each 
individual  rare  disease  is  low,  the  total  number  of  people  affected  by  one  rare  disease  or 
another in the EU lies between 27 and 36 million. Most of them suffer from diseases affecting 
not more than one in 100 000 people. These patients are particularly isolated and vulnerable. 

Because of the low prevalence of rare diseases, their specific nature and the high total number 
of  people  affected,  the  EU  calls  for  a  global  approach  based  on  special  combined  efforts  to 
prevent significant morbidity or avoidable premature mortality and to improve the quality of 
life  and  socio-economic  potential  of  sufferers.20  The  EU  has  been  taking  a  coordinated 
approach  to  address  the  issues  regarding  innovation  targeted  on  rare  diseases.  First,  the  EU 
adopted  the  Orphan  Medicinal  Products  Regulation21  which  defines  the  criteria  for 
designation  as  ‘orphan’  in  the  EU  and  offers  a  range  of  incentives  for  R&D  (e.g.  10-year 
market exclusivity, protocol assistance and access to the centralised procedure for marketing 
authorisation)  to  encourage  research,  development  and  marketing  of  medicines  to  treat, 
prevent or diagnose rare diseases. The Regulation is part of a broader strategy22 for addressing 
rare diseases which is backed up, for example, by the particular attention paid to rare diseases 
within  the  Framework  Programme.  Similar  regulations  have  been  introduced  in  the  USA, 
Japan and Australia. 

Although the orphan drug legislation is particularly relevant to developed countries, it could 
be  redesigned  for  products  to  combat  neglected  diseases23  in  developing  countries  as  well. 
The ‘pull’ factor that such legislation could generate will, however, remain limited as long as 
the  markets  for  such  products  remain  small.  Global  coordination  of  similar  regulatory 
instruments would considerably add to their impact.  

2.2.2.  Direct subsidies for research to improve global health equity 

Twenty years ago, the Commission on Health Research for Development found that only 5 % 
of the total funds were spent on research addressing the problems facing developing countries, 
which  were  bearing  93 %  of  the  global  burden  of  disease.  It  called  for  an  increase  in 
international support for health research, setting targets of 2 % of national health expenditure 
and  5 %  of  international  official  development  assistance  (ODA)  for  more  effective 
coordination  and  compliance  with  the  principles  of  ‘essential  national  health  research’ 
(ENHR) addressing ownership, participation and the pertinence of health research (the ‘Alma-
Ata of health research’).24 

20 
21 

22 
23 

24 

Council Recommendation on action in the field of rare diseases, 5 June 2009, 2008/0218 (CNS). 
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on 
orphan medicinal products. 
Communication from the Commission on ‘Rare Diseases: Europe’s challenges’, COM(2008) 679 final. 
‘Neglected  diseases’  are  a  group  of  tropical  infections  which  are  especially  endemic  in  low-income 
populations in developing regions of Africa, Asia and the Americas. Different organisations define this 
group of diseases differently. 
Commission  on  Health  Research  for  Development:  ‘Health  research,  essential  link  to  equity  in 
development’, Oxford University Press, 1990. 

EN 

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As  regards  the  levels  of  health  research  in  developing  countries,  very  few  countries  have 
made  progress  towards  the  2 %  target.  The  ‘90/10’  gap  —  with  under  10 %  of  the  world’s 
biomedical  research  funds  allocated  to  addressing  problems  behind  90 %  of  the  world’s 
disease burden — remains a challenge, as concluded at the 2008 Global Ministerial Forum on 
Research  for  Health  in  Bamako.25  On  the  positive  side,  investment  in  research  and 
development targeted on poverty-related diseases has increased significantly in recent years, 
partly as a result of more active private-sector and catalyst initiatives such as public-private 
partnerships  (PPPs)  and  product  development  partnerships  (PDPs).  Overall,  there  is  still  a 
90/10 gap, while health  disparities between and within  countries are widening. North-South 
research partnerships must be designed in equitable fashion and funding needs to be sustained 
beyond the often short-term investment in a research project.  

Further  investment  in  research  remains  necessary,  but  the  results  must  reach  low-income 
countries as well. Local ownership, training and retention of human resources for research are 
crucial.  

Research supported under the EU Framework Programme 

Global  health  research  features  prominently  in  the  EU  Framework  Programmes  in  different 
ways,  whether  in  the  field of international public health  and  health  systems, poverty-related 
diseases,  or  neglected  infectious  diseases  research.  The  programme  is  focusing  strongly  on 
supporting the research necessary to achieve the health-related millennium development goals 
(MDG). 

Specific International Cooperation Actions: SICAs 

One of the objectives of EU international cooperation on health research in connection with 
the  MDGs  is  to  address  specific  problems  that  non-EU  countries  face  or  problems  with  a 
global  dimension.  In  this  area,  Specific  International  Cooperation  Actions  (SICAs)  can 
address  particular  needs  of  developing  and  emerging  economies,  by  means  of  dedicated 
cooperative activities. SICAs  are  restricted to  non-associated non-EU countries and respond 
to  their  mutual  interest  in  cooperating  on  particular  topics  selected  on  the  basis  of  their 
scientific and technological level and needs. Identification of specific needs and priorities is 
closely  linked  to  relevant  bilateral  cooperation  agreements  and  ongoing  multilateral  and  bi-
regional  dialogues  between  the  EU  and  these  countries  or  groups  of  countries  and 
international fora or in the context of the MDGs. Priorities are based on the particular needs, 
potential  and  level  of  economic  development  in  the  region  or  country  and  may  include 
domains  stated  in  the  specific  programme  on  ‘Cooperation’,  namely  health  policy  research, 
health systems and health services research including ICT for health (eHealth), maternal and 
child  health,  reproductive  health,  control  and  surveillance  of  neglected  communicable 
diseases and emerging unforeseen policy needs in the regions concerned.  

Furthermore,  the  ‘Health’  theme  in  general  is  particularly  important,  as  it  provides  for 
research  at  global  level  to  tackle  anti-microbial  resistance,  HIV/AIDS,  malaria,  tuberculosis 
and  emerging  epidemics,  including  support  for  the  European  and  Developing  Countries 
Clinical Trials Partnership (EDCTP) in response to its achievements and future needs. 

25 

Global  Ministerial  Forum  on  Research  for  Health:  ‘The  Bamako  Call  to  Action  on  Research  for 
Health’, Bamako, Mali, 17-19 November 2008. 

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International public health and health systems 

The  focus  of  research  relating  to  international  public  health  and  health  systems  has  direct 
relevance to the international dimension of the public health policy of the European Union by 
contributing to health protection, prevention and promotion, while at the same time generating 
new knowledge relevant to health, social, environmental and economic issues. Taking cross-
sectoral and multi-disciplinary approaches, this research contributes to initiatives such as the 
millennium  development  goals  (MDG),  the  Ministerial  declarations  on  global  health 
research26  and  the  European  policy  coherence  framework  for  development,  with  particular 
emphasis  on  attaining  the  health  MDGs,  including  child,  maternal  and  reproductive  health. 
Such research also contributes to building the evidence base on health workforce management 
and  international  migration.  The  plan  is  to  focus  a  new  strategic  health  research  agenda  on 
better health  systems  performance  and more effective  preventive public health interventions 
and providing input for future EU development cooperation. This is reflected in the fourth call 
for proposals which  included,  in  particular,  a  special call on Africa.  Under the international 
cooperation (INCO) in the Sixth Framework Programme (2002-2006), some €
 34 million was 
provided to support 20 projects on health financing, access to healthcare, quality management, 
health migration and reproductive health. A comprehensive review, covering 43 FP5 and FP6 
health  systems  research  projects,  confirmed  the  significant  impact  and  contribution  to 
building  solid  North-South  partnerships27.  Furthermore,  under  the  FP6  scientific  support  for 
policy activity, an additional €

 14 million went to research on SARS. 

ICT for health actions have supported FP7 collaboration between the EU and Latin America 
in the areas of patient safety, transfer of technology, and alert and decision support systems 
based  on  grid  capabilities.  The  focus  of  this  collaboration  is  on  optimising  the  use  of 
biomedical data and computing resources. 

HIV/AIDS 

In the Sixth Framework Programme (FP6), the European Commission funded 41 projects on 
 123 million. In particular, support was 
HIV/AIDS, with a total EU contribution of more than €
given  to  research  on  (a)  therapeutic  approaches  (drugs,  RNA  interference,  therapeutic 
 52  million; 
vaccines  based  on  apoptotic  T  cells  and  others)  with  an  EU  contribution  of  €
(b) vaccines  (mucosal  vaccines,  vaccines  targeting  dendritic  cells  and  DNA  vaccines,  new 
 49  million; 
antigen  design  and  delivery  systems)  with  an  EU  contribution  of 
(c) microbicides  (design  of  new  molecules  and  use  of  anti-retroviral  drugs  to  inhibit  HIV 
replication  in  vaginal  mucosa)  with  an  EU  contribution  of  €
 22  million;  and  (d)  studies  on 
cohorts  of  HIV-infected  adults  and  children  to  investigate  insurgence  of  resistance  to 
marketed  anti-HIV  drugs  and  mother-to-child  virus  transmission.  Many  of  the  translational 
research  projects  in  FP6  included  phase  I  clinical  trials.  In  the  Seventh  Framework 
Programme  (FP7),  14  projects  had  been  funded  by  December  2009  with  a  total  EU 

26 

27 

Call  to  Action  on  Research  for  Health  from  the  Global  Ministerial  Forum  on  Research  for  Health, 
Bamako,  Mali,  17-19  November  2008;  Conclusions  of  the  Council  and  the  Representatives  of  the 
Governments  of  the  Member  States  meeting  within  the  Council  on  ‘Policy  Coherence  for 
Development’,  20  November  2007;  Statement  from  the  Ministerial  Summit  on  Health  Research, 
Mexico, 16-20 November 2004. 
North  South  Partnership  for  Health  Systems  Research  –  20  years  of  experience  of  European 
Commission support. http://ec.europa.eu/research/iscp/pdf/n_s_partnership_health_report.pdf  

EN 

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€
                                                 
 70  million,  of  which  €

 32  million  went  to  vaccines,  €

 22.5 million to treatment and about €

contribution  of  about  €
 12  million  to 
 5 million to basic research and training. 
microbicides, €
These  14  projects  covered:  study  of  vaccines,  inducing  broadly-reactive  neutralising 
antibodies;  a  platform  to  support  harmonisation  of  vaccine  adjuvant  testing;  mucosal  and 
transcutaneous  vaccines  and  translational  vaccine  research  (allocating  funds  for  phase  I  and 
IIa clinical trials); drug discovery and pre-clinical development; and paediatric formulations 
of drugs.  

Malaria 

Under  FP6,  17  malaria  research  projects  were  granted  support  totalling  €
 64  million.  These 
include  three  large  structural  projects  that  have  become  cornerstones  of  the  European 
Research  Area  in  this  field:  (a)  a  strong  basic  research  network  (NoE)  on  malaria,  (b)  an 
integrated  project  to  develop  new  antimalarial  drugs  and  (c)  the  European  Malaria  Vaccine 
Development Association, an integrated project that builds on the European Malaria Vaccine 
Initiative  (EMVI)  initiated  under  FP4  and  part-funded  by  Member  States.  In  this  way,  a 
critical  mass  of  European  malaria  research  was  built  up.  As  a  result,  the  EU  is  now  in  a 
position  to  participate  in  the  relevant  global  coordination  of  malaria  research.  Under  FP7, 
construction of an ERA in the field of malaria research needs to be consolidated where major 
structural malaria projects are already under way and extended where gaps remain in certain 
subareas (e.g. vector research). Under FP7, malaria research is being supported across the four 
 76  million  granted  up  to  December  2009.  Seventeen 
specific  programmes  with  a  total  of  €
projects  on  this  subject  are  in  progress  under  the  ‘Health’  theme  of  the  ‘Cooperation’ 
programme, two more under the ‘Capacities’ programme, three under the ‘Ideas’ programme 
and ten applications under the ‘People’ programme. The main areas funded by the EU from 
 17  million), 
2007  to  2009  were  basic  research  (€
 2 million). 
vaccine development (€

 24  million),  vector  control  research  (€
 8 million) and diagnostics research (€

 11 million), drugs (€

Tuberculosis 

Many of the research projects supported by the EU on tuberculosis (TB) aim to address the 
mechanisms  of  pathogenesis  and  the  delicate  balance  between  humans  and  the  pathogen. 
However, only translational research can lead to real applications. The BCG vaccination is not 
as effective at controlling TB as hoped and the spread of antimicrobial resistance has rendered 
most current drugs ineffective against some TB strains. Large-scale translational projects have 
proved  useful  for  bridging  the  gap  between  discovery  and  application  and  even  larger 
initiatives can be expected in the future. 

Research  of  relevance  to  TB  has  been  supported  throughout  the  Framework  Programmes, 
albeit sporadically in the early FPs. Under  FP5  (1998-2002),  the  EU  took  a  more  dedicated 
 30 million. The projects funded covered a wide range 
approach to this area, with funding of €
of  activities,  from  basic  research,  e.g.  on  mucosal  immunology,  structural  and  functional 
genomics, host-parasite relationships and population studies, to applied research for vaccine 
development, drugs and diagnostics. In FP6 (2002-2006), TB research was stepped up with a 
budget  of  €
 68  million,  shifting  the  focus  to  translational  research,  particularly  in  three 
 11  to  17  million  each)  addressing  vaccine 
integrated  projects  (with  an  EU  contribution  of  €
development, drug development and mucosal vaccines. In the first three years of FP7, up to 
December  2009,  the  EU  provided  funding  of  €
 56  million  for  TB  research,  including  large-
scale projects on clinical management of TB drug resistance and on the development of new 

EN 

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vaccines against TB. Despite the scientific progress made in this area, it is still necessary to 
continue  funding  a  multitude  of  scientific  approaches  to  TB  control,  including  basic, 
translational  and  clinical  research  and  clinical  trials.  Further  coordination  and  alignment 
within  Europe,  with  global  organisations  and,  most  of  all,  with  the  countries  where  TB  is 
endemic is crucial.28 

Neglected infectious diseases 

In  the  area  of  neglected  infectious  diseases  (NIDs),  the  Seventh  Framework  Programme  is 
building  on  the  advances  made  in  previous  FPs  that  provided  €
 70  million  to  55  research 
projects  on  NIDs  from  1998  to  2006  —  the  majority  involving  African  research  groups. 
Scientific and technological cooperation between the EU and developing countries began in 
1982  with  three  successive  Science  and  Technology  for  Development  Programmes.  Then 
1984  saw  the  launch  of  international  scientific  cooperation  based  on  bilateral  agreements 
between the EU and non-EU countries. FP4 (1994-1998) introduced the INCO (INternational 
COoperation)  programme,  which  became  one  of  the  few  international  funding  instruments 
focusing on research to control neglected infectious diseases. Twenty-seven INCO projects on 
NIDs  received  total  funding  of  some  €
 45  million  under  FP6  for  2002-2006.  INCO  health 
projects  have  global  scope,  with  46  partner  countries  taking  part.  They  have  helped  link  up 
public  authorities,  NGOs  and  other interested  parties,  spreading  best  practice.  Such  projects 
have  covered  a  range  of  relatively 
leishmaniasis, 
schistosomiasis, 
trypanosomiasis,  dengue  and 
haemorrhagic  fever,  echinococcosis,  buruli  ulcer  and  other  childhood  infections.  Work 
included  vector  control,  vaccines  and  development  of  innovations  like  traps  for  tsetse  flies 
and solar-powered disinfection of drinking water.29 

filariasis,  onchocerciasis, 

little-known  diseases, 

lymphatic 

including 

FP7 is focusing more on applying new modern research methods and technologies to develop 
new medicines and prophylactics against these diseases. The aim is to establish an integrated 
approach to development of preventive, therapeutic and control tools based on collaboration 
between  European  and  international  partners,  including  researchers  from  countries  where 
these  diseases  are  endemic.  Activities  in  this  area  include,  to  give  just  a  few  examples, 
parasitic diseases caused by trypanosomatidae species (e.g. trypanosomiasis, Chagas disease 
and  leishmaniasis),  bacterial  diseases  such  as  Buruli  ulcer,  leprosy  and  trachoma,  helminth 
diseases  such  as  schistosomiasis,  filariasis  and  other  neglected  infectious  diseases  such  as 
infantile diarrhoea. Projects are addressing both preclinical and early clinical activities, along 
with  the  particular  health  conditions  and  health  needs  of  countries  where  these  diseases  are 
endemic.  An  integrated  multidisciplinary  approach,  including  significant  participation  by 
partners  from  areas  where  these  diseases  are  endemic  and,  where  relevant,  industry,  is 
strongly encouraged, including, where applicable, technology transfer, training activities and 
human capacity-building. 

European and Developing Countries Clinical Trials Partnership (EDCTP)  

28 

29 

Lang,  H.,  Quaglio,  G.L.  and  Olesen,  O.F.:  ‘Tuberculosis  research  in  the  European  Union:  Past 
achievements and future challenges’. Tuberculosis (2010) Vol. 90.1: 1-6. 
For  further  details  see:  ‘Final  Report  International  Conference  on  Neglected  Infectious  Diseases’, 
Brussels  8-9  November  2006:  http://ec.europa.eu/research/health/infectious-diseases/neglected-
diseases/pdf/nid-conference-final-report052007_en.pdf. 

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The European and Developing Countries Clinical Trials Partnership was set up in 2003 as a 
European  response  to  the  global  health  crisis  caused  by  the  three  main  poverty-related 
diseases — HIV/AIDS, malaria and tuberculosis.30 Fourteen EU Member States together with 
Norway  and  Switzerland  have  pledged  €
 200  million  for  this  partnership,  which  will  be 
 200 million from the EU Framework Programme. Essentially, EDCTP provides 
matched by €
a  platform  for  conducting  clinical  trials  with  a  particular  focus  on  phases  II  and  III  and 
developing the capacity required in sub-Saharan countries. Clinical trials are an essential step 
to assess the viability and suitability of drugs, vaccines and microbicides. Trials occur late in 
the development of products, when their safety and efficacy in human beings are tested. They 
are expensive and require high standards of regulations and ethics in the countries concerned. 
Clinical trials can be a bottleneck if there is not enough financial support or capacity. EDCTP 
aims to bridge these gaps. 

EDCTP  supports  multicentre  projects  which  combine  clinical  trials,  capacity-building  and 
networking.  The  aim  of  integrating  these  three  activities  is  to  ensure  that  the  capacity 
developed  is  used  to  conduct  the  clinical  trials  successfully  and  sustainably.  Besides 
successful outcomes, this also makes sure that the capacity developed is used optimally and 
retained,  thus  securing  sustainability.  The  networking  component  facilitates  north-south 
technology  transfer  and  south-south  mentorship,  allowing  dissemination  of  the  capacity 
developed  and  building  up  critical  mass.  In  addition,  the  partnership  supports  Africa’s 
capacity for ethical reviews, regulatory frameworks and  clinical trials registration  for  health 
research.  Such  support  includes  grants  to  establish  and  strengthen  institutional  and  national 
ethics  committees  and  enable  them  to  become  functional  and  independent.  Support  is  also 
provided  for  strengthening  and  harmonising  national  regulatory  authorities  and  to  improve 
registration  of  clinical  trials  in  Africa  by  means  of  the  recently  established  Pan-African 
Clinical  Trials  Registry.  EDCTP  also  supports  various  types  of  training  on  ethics  and 
regulatory frameworks and is mapping the ethics and regulatory capacity in Africa. 

There  is  generally  a  wide  disparity  between  research  capacity  and  regulatory  and  ethics 
oversight for conducting clinical trials in Africa. This divide is likely to widen considering the 
traditional ways of awarding grants in which excellence is rewarded at the expense of under-
developed  capacity  in  less-endowed  centres.  This  problem  is  compounded  by  channelling 
support through traditional ties between northern and southern institutions that usually favour 
advanced  centres.  To  mitigate  this,  EDCTP  has established  regional  networks  of  excellence 
for  conducting  clinical  trials.  They  are  divided  into  Central,  Eastern,  Southern  and  Western 
African  regions  and  bring  together  institutions  with  varying  but  complementary  capacity 
which work in synergy to conduct clinical trials and provide training, south-south mentorship 
and capacity-building in Africa. EDCTP unites the 14 participating EU  Member States plus 
Norway  and  Switzerland  with  sub-Saharan  African  countries.  The  partnership  helps  EU 
Member  States  to  integrate  and  coordinate  their  own  national  research  and  development 
programmes and form partnerships with their African counterparts.  

After a slow and cumbersome  start-up  phase,  when  EDCTP  had  to  set  up  its  own  guidelines, 
regulations and governance structure and to explore ways of working under new and untried 
conditions, EDCTP has now established a credible governance and administrative structure that 
includes robust and transparent peer review, a solid accounting and auditing system, an independent 

30 

Decision  No  1209/2003/EC  of  the  European  Parliament  and  of  the  Council  of  16  June  2003  on 
Community participation in a research and development programme aimed at developing new clinical 
interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between 
Europe and developing countries, undertaken by several Member States. 

EN 

15 

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advisory  structure  for  scientific  and  strategic  matters  and  an  efficient  secretariat.31  To  date, 
 300 million and involving 135 institutions 
EDCTP has funded 168 projects valued at over €
from  28  sub-Saharan  countries,  72  institutions  from  17  European  countries  and  51  other 
partners — non-profit organisations and private-sector partners. In all, EDCTP is funding 51 
clinical trials — 23 on HIV/AIDS, 17 on tuberculosis and 11 on malaria. African researchers 
make up 68 % of the coordinators of EDCTP projects. 

EDCTP is currently operating under a no-cost extension until September 2010. As required by 
the  Decision  setting  up  EDCTP,  in  June  2009  the  Commission  initiated  an  independent 
external evaluation of its activities over the period 2003-2008. Based on this external review 
and  a  thorough  internal  impact  assessment,  the  Commission  will  decide  if,  and  on  which 
basis, it will propose to renew EDCTP beyond 2010. This might involve broadening the scope 
either  geographically  (beyond  sub-Saharan  Africa  to  other  countries  where  diseases  are 
endemic)  or  in  terms  of  the  diseases  addressed  (to  neglected  diseases)  and  types  of  clinical 
trials supported (to phases I and IV).  

Innovative Medicines Initiative 

The EU and the European Federation of Pharmaceutical Industries and Associations (EFPIA) 
have  established  a  new,  non-profit  body,  the  Innovative  Medicines  Initiative  (IMI)  joint 
undertaking (JU).32 This pan-European collaboration brings together large biopharmaceutical 
companies,  small  and  medium-sized  enterprises  (SME),  patients’  organisations,  academics, 
hospitals and public authorities. The initiative aims to speed up discovery and development of 
better  medicines  by  clearing  bottlenecks  in  the  drug  development  process  by  taking  a 
coordinated  approach  and  supporting  pre-competitive  pharmaceutical 
research  and 
development.  It  also  aims  at  increasing  the  research  investment  in  the  biopharmaceutical 
sector  in  the  EU  by  pooling  resources  and  fostering  collaboration  between  the  public  and 
private  sectors.  It  focuses  on  creating  better  methods  and  tools  that  will  improve  the  drug 
development process, rather than on developing specific new medicines. 

The IMI JU has a mandate to award research grants to European public-private joint ventures 
conducting  innovative  research  projects  that  focus  on  implementing  the  recommendations 
made  in  the  IMI  research  agenda.  Funding  for  such  research  is  provided  in  equal  measure 
from the EU Framework Programme and members of the EFPIA. The total IMI budget for the 
 1 billion  in-kind 
period  2008-2017  is  €
contribution from industry). The first call for proposals was published in April 2008. A total 
 246 million. The first 
of 134 proposals were submitted, of which 15 were selected to receive €
call  focused  on  non-communicable  diseases  that  are  particularly  prevalent  in  Europe.  The 
second,  published  in  November  2009,  includes  diagnostics  for  tuberculosis  and  pneumonia, 
which place a particularly heavy disease burden on low-income countries. 

 1  billion  from  the  EU  in  cash  and  €

 2  billion  (€

The IMI research agenda was established under the leadership of industry following intensive 
consultations with a broad range of stakeholders from across Europe. It identifies the principal 
bottlenecks  in  biopharmaceutical  R&D  and  makes  recommendations  to  overcome  them 
focusing on four areas:  

31 

32 

Communication  from  the  Commission  on  the  Progress  Report  on  the  ‘European  and  Developing 
Countries Clinical Trials Partnership’ Programme, COM(2008) 688 final. 
Council  Regulation  (EC)  No  73/2008  of  20  December  2007  setting  up  the  Joint  Undertaking  for  the 
implementation of the Joint Technology Initiative on Innovative Medicines. 

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•  Predicting  safety:  this  addresses  bottlenecks  in  accurately  evaluating  the  safety  of  a 
compound  during  the  pre-clinical  phase  of  the  development  process,  but  also  has  an 
impact on the later phases of clinical development. 

•  Predicting efficacy: this addresses bottlenecks in the ability to predict how a drug will 

interact in humans and how it might produce a change in function. 

•  Knowledge  management:  this  underpinning  theme  addresses  more  effective  use  of 

information and data for predicting safety and efficacy. 

•  Education and training: this second underpinning theme closes existing training gaps 

in the drug development process. 

Precompetitive  research  platforms  like  IMI  are  expected  considerably  to  improve  the 
efficiency  of  research  and  development.  Public  co-funding  of  such  platforms  is  justified  by 
the  fact  that  the  findings  of  such  research  will  be  available  to  many  developers  rather  than 
being the property of just one company. Due to the public nature of such research findings, 
important  basic  research  would  otherwise  be  underprovided.  Advances  achieved  by 
precompetitive research platforms will be useful for developing a range of medical products 
in that particular medical area, but might not be for different diseases. If they are to have a 
great  impact  on  global  health,  such  platforms  would  therefore  have  to  focus  on  the  specific 
needs of developing countries, the diseases that are most prevalent, and where pharmaceutical 
innovation is particularly needed. 

Other innovative means of financing 

Identification  of  medical  knowledge  as  a  global  public  good  for  health  that  needs  effective 
public  policies  and  additional  funding  to  make  it  accessible  to  all  has  triggered  a 
comprehensive debate at global level on better ways to coordinate and finance research and 
development that is also relevant to developing countries. The discussions at global level are 
shaped  by  the  WHO  Global  Strategy  and  Plan  of  Action  on  Public  Health,  Innovation  and 
Intellectual  Property  (see  section  1.2)  which  stresses  that  further  sustainable  funding  is 
essential  to  support  the  long-term  efforts  required  to  meet  the  health  needs  of  developing 
countries.  The  WHO  subsequently  set  up  an  expert  working  group  that  examined  current 
financing  and  coordination  of  research  and  development  and  proposals  for  new  and 
innovative sources of financing to stimulate research and development relevant to developing 
countries. Its report will be discussed by the World Health Assembly in May 2010.33 In any 
event,  effective  mechanisms  to  fund  research  must  be  further  explored,  such  as  product 
development  partnerships  (PDP),  public-private  partnerships  (PPP)  or  funding  trials  in 
developing countries, such as EDCTP. The impact of regulation (e.g. patents, priority review 
vouchers or orphan drugs regulation) needs to be continuously evaluated. 

2.3. Equitable access to knowledge and implementation of results 

Whether  science  can  help  to  improve  health  at  global  level  depends  not  only  on  whether 
relevant  research  will  in  fact  be  undertaken,  but  also  on  whether  the  resultant  knowledge, 
once produced, can be translated into evidence-based services or products that improve public 
health in an equitable manner. Policy-makers and researchers must make continuous efforts to 
transmit research findings and translate them into evidence-based decisions. Evidence-based 

33 

Report  by  the  World  Health  Organisation  Expert  Working  Group  on  Research  and  Development 
Financing, World Health Organisation, Geneva. 

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policies can only be grounded in country-led research and learning that can be backed up by 
global support. This requires domestic leadership and sustained investment in local capacity-
building  for  analysis  and  learning,  robust  systems  for  monitoring  and  evaluation  and  better 
direct  access  for  country-based  researchers  to  funding  opportunities.  This  will  make  it 
possible to design and manage health systems that offer universal and equitable access with 
the  necessary  inputs  (financing,  human  resources,  supplies,  information  technology, 
governance, etc.) that are based on the best evidence available and respond to local needs and 
realities.  The  inadequate  access  to  medical  innovations  in  developing  countries  is  caused 
partly  by  a  sometimes  defunct  health  system,  a  key  ‘access  good’  as  a  functioning  health 
system is necessary to deliver the ‘public good’ of knowledge and the products and services 
produced from that knowledge. 

2.3.1.  Open access 

Science is a collaborative process and openness is fundamental to advance knowledge. Access 
to  health  research  publications  is  an  essential  requirement  for  securing  the  chain  of 
communication from the researcher to the front-line health worker. There is global inequity in 
access to published health literature by research communities in developing countries. Rising 
costs of subscriptions and permission barriers imposed by publishers have barred access to the 
extent  that  local  health  research  and  healthcare  have  been  weakened.34  If  research  requires 
public  subsidies  —  as  it  would  be  underprovided  otherwise  —  due  to  its  nature  as  a  public 
good,  then  the  results  of  the  research  should  become  a  public  good  as  well.  As  part  of  its 
Seventh  Framework  Programme  (FP7),  the  European  Commission  is  conducting  a  pilot 
project  to  provide  open  access  to  peer-reviewed  research  articles  within  a  specified  period. 
This initiative covers approximately 20 % of all the projects funded under the FP7 budget and 
includes health research.35 

2.3.2.  Local capacity 

Effective  and  evidenced-based  health  policy  making  requires  considerable  expertise  and 
multidisciplinary  research  capacity  at  national  level.  The  EU  instruments  described  above 
provide  strong  support  for  developing  local  scientific  capacity.  The  considerable  but  very 
different support offered by development assistance and the Framework Programme makes it 
difficult  for  national  research  policy  and  health  policy-makers  to  create  sustainable 
programmes. Official development assistance often gives priority to primary, secondary and 
vocational education, which is key to ensuring employability. In addition, the EU strategy for 
Africa of 200536 emphasises the importance of cooperation with Africa in higher education to 
build high quality tertiary capacity by means of networking, mobility of students and scholars, 
and  institutional  support  and  innovation.  There  are  now  opportunities  for  collaboration 
between  higher  education  institutions  under  the  education  programmes  Erasmus  Mundus 
Programme37, Edulink38, and the Mwalimu Julius Nyerere programme39. The FP7 special call 

34 

35 
36 
37 
38 
39 

Yamey,  G.:  ‘Excluding  the  poor  from  accessing  biomedical  literature:  a  rights  violation  that  impedes 
global health’, Health and Human Rights 2008:10. 
Commission Decision C(2008) 4408 final, 20.8.2008. 
COM (2005) 489 
Decision 1298/2008/EC, 16 December 2008. http://eacea.ec.europa.eu/erasmus_mundus/ 
http://www.acp-edulink.eu/  
http://ec.europa.eu/development/policies/9interventionareas/humandev/humandeveduc5_en.cfm  

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on  Africa40  paid  particular  attention  to  research  capacity  building  and  training.  Howver, 
competitive research calls are looking for scientific excellence, which can be difficult to build 
up and sustain without considerable external funding. Coherent EU action could provide more 
effective support for developing countries to create and retain scientific expertise by helping 
to  strengthen  institutions  that  build  capacity  in  health  and  health  sciences  and  supporting 
national  innovation  systems  to  develop  treatments  and  health  systems  that  are  suitable  and 
appropriate for the national setting.  

International  scientific  cooperation  is  possible  and  fruitful  only  if  sufficient  scientific 
expertise  is  available  in  the  partner  country  to  enable  bilateral  learning.  The  benefits  of 
regional  cooperation  on  research  have  been  realised  in  the  EU  and  supported  by  the 
Framework Programme. The EU would be best placed to provide assistance for establishing 
regional  or  south-south  partnerships  for  research.  One  promising  example  set  up  with  the 
support of the EU is the African Network for Drugs and Diagnostics Innovation (ANDI). Its 
task is to promote and sustain African-led innovation in health products that addresses African 
public  health  needs  by  putting  together  research  networks  and  building  capacity  to  support 
human and economic development.17 18 41 

2.3.3.  Translation of knowledge into clinical care provision (implementation 
research) 

To optimise healthcare delivery, it is necessary to understand not only how to design the most 
effective  intervention,  but  also  the  best  way  to  ensure  that  it  is  delivered  effectively  and 
applied in clinical practice. Building up this knowledge base with the aid of implementation 
research is imperative in order to get the best return on decades of investment in biomedical 
research. All relevant knowledge available, including indigenous and traditional knowledge, 
should be tapped to improve health and health systems. 

Most researchers who propose to develop and test disease control methods either explicitly or 
implicitly  intend  to  promote  efficacious  intervention  either  amongst  the  broader  population 
from  which  the  sample  for  the  efficacy  study  was  drawn  or  in  the  public  health  or  clinical 
practice  settings  in  which  the  method  was  originally  tested.  For  many  years,  health 
researchers tended to assume that a method found efficacious in clinical or community-based 
trials  would  be  easily  transmitted  to  the  field.  Evidence  suggests  that  this  has  not  been  the 
case. Moreover, little is known about effective approaches to overcome barriers to adoption of 
evidence-based intervention.  

Recent  literature  has  underscored  the  importance  of  understanding  the  multiple  factors  that 
influence whether public health or clinical practice communities will use a given method. The 
EU  Framework  Programme  is  funding research on implementation addressing the degree to 
which health intervention can fit into real-world public health and clinical service systems. 

2.3.4.  Translation of knowledge into policies (health services research) 

Health services research is a multidisciplinary field of scientific investigation that studies how 
social factors, financing systems, organisational structures and processes, health technologies 

40 

41 

Call  for  proposals  FP7-AFRICA-2010  published  on  30  July  2009  with  a  deadline  of  14.1.2010. 
Successful projects are expected to start beginning of 2011. 
 http://andi.tropika.net/  

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and  personal  behaviour  affect  access  to  healthcare,  the  quality  and  cost  of  healthcare  and, 
ultimately,  individuals’  health  and  well-being.  Although  the  Member  States  are  responsible 
for organising them, health systems in the European Union are all based on the shared values 
of  universality,  solidarity  and  equitable  access  to  quality  healthcare.  The  EU  Framework 
Programme  supports  cross-border  collaboration  to  establish  the  evidence-base  by  means  of 
comparative health systems research that can then be used by national decision-makers when 
they  reform  their  health  system.  This  knowledge  is  necessary  in  order  truly  to  learn  from 
successes and failures in healthcare delivery in other countries, be they in Europe or beyond. 
That  is  why  this  form  of  research  collaboration  may  include  partners  from  developing 
countries  and  regularly  target  issues  particularly  relevant  to  developing  countries’  health 
systems in specific international cooperation activities. 

3.  Conclusions 

The  European  Union  can  play  a  key  role  in  addressing  the  weaknesses  that  are  currently 
preventing  realisation  of  the  full  and  equitable  benefits  that  research  can  offer  for  global 
health. The EU institutions and the existing structures and instruments at European level offer 
great  potential  for  coordinating  the  European  response  to  the  challenges  of  knowledge  for 
global health. The instruments and policies described above could enhance the EU response 
proposed in the Communication in the following ways: 

In order to coordinate more effectively EU research for global health that benefits the health 
of all people, the existing strong institutional links in the EU could serve to define a common 
EU  position  on  the  research  priorities,  the  distribution  of  research  between  various  entities, 
sectors  and  geographical  areas,  and  the  financing  of  research  and  development.  Global 
coordination of these issues will not be realistic without a strong European voice and common 
position. The EU in general and the European Commission in particular are well represented 
in the many global initiatives aiming — so far unsuccessfully — to coordinate research and 
development at global level. 

The EU Research Framework Programmes should be based on joint priority setting processes, 
equitable  partnerships  and  safeguard  access  to  the  knowledge  generated.  The  focus  on 
collaborative  international  research  consortia  in  the  ‘Cooperation’  programme,  addressing 
research topics that are often beyond the remit of national research consortia alone, could be 
harnessed  to  foster  sustainable  global  collaboration  on  health  research.  Building  on  the 
existing  research  collaboration  on  poverty-related  diseases  and  expertise  in  comparative 
health  systems  research,  the  European  expertise  in  research  on  non-communicable  diseases 
could  be  an  additional  driver  for  international  scientific  cooperation  on  global  health.  The 
impact of the innovative partnership instruments that the EU has established with the private 
sector  (IMI  JU)  and  developing  countries  (EDCTP)  will  be  evaluated,  as  required  by  the 
decisions establishing them. Making these initiatives more effective will provide the EU with 
powerful  and  innovative  tools  to  support  generation  of  new  knowledge  relevant  to  global 
health and also to build in the need for equitable access to innovative products and treatments 
embedding that new knowledge. The IMI Joint Undertaking should continue to include pre-
competitive research that is relevant to diseases with an impact on global health. EDCTP has 
the potential not only to support the crucial but expensive clinical trials that are necessary to 
develop  drugs  or  medical  devices  relevant  to  health  in  Africa  but  also  to  extend  the 
partnership and joint learning to other diseases and other developing countries. 

The  EU  should  strengthen  and  balance  the  complete  health  research  process  of  innovation, 
implementation, access, monitoring and evaluation; and inform health policies, including the 

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development of national research capacities. Implementation of new knowledge and equitable 
access  to  innovative  products  and  treatments  needs  to  be  built  into  the  entire  innovation 
process in order to provide meaningful results for global health. This implies evaluating and 
addressing the impact of IPR on global health. The EU is one of the key actors in discussions 
on  the  Global  Strategy  and  Plan  of  Action  on  Public  Health,  Innovation  and  Intellectual 
Property. In the case of research on rare diseases, not only collaboration on pre-clinical and 
clinical research seems pertinent, but also closer international collaboration on regulating the 
market for rare or other neglected diseases, in order to create effective incentives that reward 
development  of  new  treatments  and  diagnostics  for  them  by  the  private  sector.  To  deliver 
innovative  medical  products  and  treatments  effectively  to  the  people  in  need,  even  more 
research  is  necessary  both  on  take-up  and  dissemination  of  new  knowledge  and  on  health 
services including the supporting IT tools to provide the evidence-base for national decision-
makers  when  they  build  or  reform  their  health  systems  so  that  they  can  provide  services 
effectively to the population that needs  them. As knowledge for health is a powerful global 
public good and the health system is an important access good, it is in the interest of the EU to 
build  capacity  in  both  health  and  health  research  in  developing  countries  and  to  invest  in 
sustainable  structures  to  support  this  capacity-building.  Coordination  between  the  various 
instruments  that  the  EU  has  at  its  disposal,  particularly  the  European  Development  Fund 
(EDF)  and  the  Framework  Programme  for  Research,  will  create  synergies  that  will 
considerably increase the impact of EU action in these fields. 

The EU should work with relevant national and international bodies such as the WHO, OECD 
and the Health Metrics network to improve health information systems and the collection of 
comparable  data  and  statistics  to  enable  benchmarking  and  inform  global  and  national 
policies.  The  EU  should  equally  promote  the  use  of  ICT  for  health  (eHealth).  Decisions  in 
managing  health  care  or  health  care  systems  should  be  based  on  the  best  information 
available.  EHealth  solutions  offer  great  potential  for  improving  health  service  provision.  A 
meaningful  analysis  of  health  systems  requires  data  that  is  comparable  with  other  health 
systems. Coordination of the national health information systems in the EU has improved the 
comparability  of  such  data  and  consequently  its  value  for  decision  makers  in  the  Member 
States. Closer global coordination of health information systems would reduce the burden of 
the different reporting requirements and enhance the opportunities for joint learning. Reliable 
and comparable health statistics at global level are an important cornerstone of effective and 
equitable global policies for health. 

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