EN    EN EN 
 
EN    EN  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 COMMISSI ON TO THE COUNCIL, THE 
EUROPEAN PARLIAMENT, THE EU ROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMI TTEE OF THE REGIONS 
 
The EU Role in Global Health 
{COM(2010) 128} 
{SEC(2010) 380} {SEC(2010) 382} 
 
 
EN 2   EN COMMISSION STAFF WORKING DOCUMENT 
European research and knowledge for global health 
Contents  
 
1. Introduction................................................................................................................ .. 3 
2. 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 P ublic Health, Innova tion 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 pr iority-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 pr ovision (implementation research).... 19 
3.3.4. Translation of knowledge into polic ies (health services research) ............................ 19 
4. Conclusions................................................................................................................ 2 0 
 
EN 3   EN Introduction 
This paper, accompanying the Communicati on on the EU Role in Global Health,1 describes 
the valuable input that resear ch can offer for improving global  health. The factors enabling 
and impeding innovation targeted on health for all are describe d 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 ma jor contribution to improving longevity and 
quality of life in Europe and beyond. Howe ver, innovation can only make a meaningful 
contribution to public health if it can be put to  the benefit of the entir e 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 i ssues therefore need to be built into the 
research process at an early stage. 
Knowledge can generally be considered a ‘ public good’ that is unde rprovided in perfect 
markets as there is no direct  link between the costs of pr oduction and the benefits of 
consumption. In order to benefit fully from me dical research, public in tervention is necessary. 
This can take the form either of public subsidie s for research (e.g. grants ) or of a regulatory 
framework that allows the privat e 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, th e EU has been supporting research across the 
entire innovation cycle: from  the discovery of potential h ealthcare 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 re sult 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 gran ted 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 increasi ng investment in research and development 
(R&D), pharmaceutical companies are not re filling the product pipeline effectively. 
Consequently, the number of novel medicines re aching the market is decreasing. Second, IPR 
provide big incentives to deve lop 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 an d known to maximise the quality of healthcare 
and what is being delivered in practice. 
 
It is therefore essential that:  • research priorities are geared to maki ng the biggest impact on public health (see 
section 2.1); 
                                                
 
1 COM(2010) xxx of xx.xx.2010. 
2 Commission Communication ‘Enhancing the patent system in Europe’, COM(2007) 165 final. 
 
EN 4   EN • public research funding and regulation of me dical innovations are coherent and aligned 
with those priorities (see section 2.2); 
• the needs of the populations currently unde rserved 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 classifi ed 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 excluda ble). 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 av ailable to all (non-ex cludable). A classical 
example is a lighthouse, whose benefits are availa ble to all ships all th e time. Public goods are 
underprovided in free markets, as there is no na tural 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 wit hout 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 theref ore 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). Th e forms of incentive and amount of direct 
subsidies differ widely from country to count ry, 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 know ledge 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 c onsumption, and for which it is irrational to 
exclude an individual nation from consuming, ir respective 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-inter est. Even though the con cept calls for ‘c ollective action’, this does 
not mean that all collective action that is wort hwhile 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 count ries 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 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. 
4 Sandler, T: ‘Global and Regional Public Goods: A Prognosis for Collective Action’, Fiscal Studies 
1998, 19:221-247. 
 
EN 5   EN sharing the costs and net benefits fairly, su ch global collaboration could improve health 
equity.5 
Research and development to generate medi cal knowledge is anothe r example of a public 
good that is inherently global in nature. Me dical knowledge includes diagnosis, prevention 
and cure of diseases, understa nding health risks and the effectiveness of health delivery 
systems and traditional medicine. However, the end-use of knowle dge, particularly when it is 
embodied in a product or service, is predomin antly 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 collectiv e 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 th at 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 dise ases) or too poor. New approaches to incentives, 
financial mechanisms and coordination of stak eholders 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 an d affordable for poor communities. The WHA 
adopted Resolution WHA 59.24 on Public Health, Innovation, Essential H ealth Research and 
IPR: Towards a Global Strategy and Plan of Ac tion. Among other prop osals, the resolution 
requested the Director-General of the World H ealth Organisation (WHO) to establish an inter-
governmental working group open to all intere sted Member States to develop a global 
strategy and plan of action with the aim, inter alia , of securing an enha nced 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 fundi ng needs in this area. After extensive and 
lengthy discussions and negotia tions in the Intergovernment al Group, the WHA adopted the 
Global Strategy and Plan of Ac tion on Public Health, Innova tion 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 ra ther than market-driven research to target 
diseases that disproportionately a ffect people in developing countries. 
 
1.3. EU Framework Programme 
                                                 
5 Kaul, I. and Faust, M.: ‘Global public goods and h ealth: taking the agenda forward’, Bulletin of the 
World Health Organisation, 2001, 79: 869–874. 
6 Smith, R.D. and MacKellar, L.: ‘Global public goods and the global health agenda: problems, priorities 
and potential’, Globalisation and Health, 2007, 3:9. 
7 Resolution WHA56.27: Increasing Access to Essential Medicines, fifty-sixth World Health Assembly, 
Geneva, 19–28 May 2003, World Health Organisation. 
8 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. 
 
EN 6   EN The main instrument for implementi ng the EU’s research policy is the Framework 
Programme of the European Community for research, technologi cal 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 program me with the highest budget is 
‘Cooperation’ (€  32.413  billion for 2007-2013), which supports health research (the Health 
Theme has a budget of €  6.1 billion, the ICT (eHealth) Theme an additional €  450  million, 
which is relatively small when compared with  the actual needs a nd the level of funding 
provided by other public or private international f unding agencies). 
The objective of FP7 is to strengthen industria l competitiveness and to meet the research 
needs of other Community policies, including  health, thereby cont ributing to creating a 
knowledge-based society, building on a Europ ean 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 over arching aim is to contribute to sustainable 
development in the context of pr omoting research, the primary pur pose of which is to increase 
knowledge at the highest level of excellence. 
International cooperation offering European adde d-value and of mutual interest supports an 
international science and tec hnology (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 an d emerging economies, 
by engaging the best scientists to  work in and with Europe; and  
– to address specific problems that non-EU countri es 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 resear ch institutions from all countries, with 
particular emphasis on encouraging non-EU part icipation in identified areas of mutual 
interest. 
• Specific cooperation targeted on non-EU countries in cases of mu tual interest in cooperating 
on particular topics selected on the basis of their scie ntific and technologi cal level and needs. 
Identification of specific needs and priorities is closely linked to relevant  bilateral cooperation 
agreements and ongoing multilateral and bi-regi onal 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 th e region or country. To this end, a Strategic European 
Framework for International Science and Technology Cooperation11 has been developed with 
                                                 
9 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). 
10 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). 
11 Communication from the Commission to the Council and the European Parliament, COM(2008) 588 
final of 4 September 2008. 
 
EN 7   EN the main objective of contribu ting to global sustainable devel opment and fostering Europe’s 
scientific and technol ogical excellence.  
This framework aims to contribute to the fr ee circulation of knowle dge — ‘the EU’s fifth 
freedom’ — at global level. More specifically, it is designed to: strengthen coordination of 
Member States’ and EU-funded act ion with the aim of reinforc ing strategic S&T cooperation 
and information society dialogues  with partners worldwide; generate additional synergies 
between public authorities,  industry and civil soci ety to make EU action in these policy fields 
more efficient; facilitate acce ss to knowledge, resources and markets worldwide; have a 
positive influence on the global science and te chnology 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 ri ght of access to information; improve the 
conditions under which international research is conducted and promote the European model 
of convergence to make information society po licies more effective; make it easier for 
Europe’s researchers and unive rsities 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 hea lth research and innovation have increased 
considerably — more than five-f old since 1986 to more than €
 160 billion per year 
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 indivi dual 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 hea lthy Europe-wide scientific competition while 
ensuring the appropriate level of cooperation and coordinati on. Research priorities are 
identified and agreed within the EU in the light of the Framework Programmes, the basis on 
which all research-related EU ac tion 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 d ealing with health and in put from an advisory 
board of about 20 outstanding scientists in the fi eld. Each WP has to be  discussed and agreed 
by the Programme Committee that brings togeth er representatives from every EU Member 
                                                 
12 Global Forum for Health Research: ‘Monitoring financial flows for health research 2008’, Washington 
DC, 2009. 
13 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). 
14 Council conclusions on a ‘202 0 Vision for the European Re search Area’, 2 December 2008. 
 
EN 8   EN State (and 10 non-EU countries), most of whic h are represented by the ministry responsible 
for research. This coordination is a formal a nd lengthy process but can take into account the 
views of various stakeholders (policy-makers, hea lth professionals, scientis ts, patients, etc.) at 
both European and national levels.  
For international coordination of research beyond  Europe, a range of different mechanisms for 
consultations and joint prior ity-setting have evolved under th e 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 Europ ean 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 coor dination on ‘Health’ topics, for example on 
migrant health, poverty-related diseases a nd capacity-building fo r health research. 
The ‘Health’ theme of the specific program me 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 partne rships, include health 
policy research, health systems and healthcare service research, maternal and child health, 
reproductive health, control and surveillance of neglected communi cable diseases and 
emerging unforeseen policy needs in the regions concerned. In  a two-way process combining 
active participation in major conf erences discussing the global agenda for research on health 
(such as the Global Forum a nd Ministerial Summits (Mexico 2004 and Bamako 2008)) with 
specific scientific conferences (for example, the biannual C ongresses on Tropical Medicine 
and International Health last held in Verona, Italy, in September 2009), the Commission is 
contributing to further development of this age nda 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 a nd operating within internati onal frameworks for dialogue 
and agenda-setting based on its concepts of mutu al benefit, equitable partnership and global 
agreements, such as the millennium developmen t goals. Most prominently, the Commission is 
closely engaged with the WHO and its aligne d programmes, such as the Tropical Disease 
Research Programme, the World A lliance 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 Committ ee for Health Research (ACHR) set up in 1959 
to support the WHO in its const itutional role of prom oting and coordinating research relating 
                                                 
15 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 esta blish 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 re gions or countries in the Framework Programme. 
16 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. 
 
EN 9   EN to international health work, acting in close coopera tion with external in stitutions pursing 
common goals and with the scientific commun ity at large. The WHO Regional Office for 
Europe also has an Advisory Committee for He alth Research, in which the Commission has 
likewise participated as an observer. The Co mmission is also repres ented on the WHO World 
Alliance for Patient Safety Research Council, whos e 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 orga nisation, the Commission has also 
played a proactive and construc tive 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 dise ases and improving access to medicines in 
developing countries by pharmaceutical-relate d 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 Internati onal Research Organisations (HIROs), the Gates 
Foundation, the National Institutes of Health (NIH) and the Wellcome Trust, in order to 
increase synergies and complementarity. Buil ding on its rich experience on agenda- and 
priority-setting with in ternational partner coun tries, 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 pr iorities 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 innovati on can help to addre ss the challenge of 
pharmaceutical companies refilling the product pi peline, 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 h ealth equity can be achieved, so that 
populations underserved by scie ntific progress can benefit in an equitable way.  
 
                                                 
17 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. 
18 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. 
19 Communication from the Commissi on: Executive Summary of the Ph armaceutical Sector Inquiry 
Report, COM(2009) 351 of 8 July 2009. 
 
EN 10   EN 2.2.1.  Better regulation; building on th e 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 num ber of people affected by one rare disease or 
another in the EU lies between 27 and 36 million. Mo st of them suffer from diseases affecting 
not more than one in 100  000 people. These patients are partic ularly 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 ap proach based on special combined efforts to 
prevent significant morbidity or avoidable prem ature mortality and to improve the quality of 
life and socio-economic pot ential of sufferers.20 The EU has been taking a coordinated 
approach to address the issues regarding innova tion targeted on rare diseases. First, the EU 
adopted the Orphan Medici nal 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 acce ss to the centralised procedure for marketing 
authorisation) to encourage re search, development and marke ting of medicines to treat, 
prevent or diagnose rare diseases. The Re gulation 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 regula tions 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 ge nerate 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 developmen t assistance (ODA) for more effective 
coordination and compliance with the principl es of ‘essential national health research’ 
(ENHR) addressing ownership, participation and the pertinence of health  research (the ‘Alma-
Ata of health research’).24 
                                                 
20 Council Recommendation on action in the field of rare diseases, 5 June 2009, 2008/0218 (CNS). 
21 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on 
orphan medicinal products. 
22 Communication from the Commission on ‘Rare Diseases: Europe’s challenges’, COM(2008) 679 final. 
23 ‘Neglected diseases’ are a group of tropical infections which are especially endemic in low-income 
populations in developing regions of Africa, Asia a nd the Americas. Different organisations define this 
group of diseases differently. 
24 Commission on Health Research for Development: ‘Health research, essential link to equity in 
development’, Oxford University Press, 1990. 
 
EN 11   EN As regards the levels of health  research in devel oping 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 alloca ted to addressing problems behind 90  % of the world’s 
disease burden — remains a challenge, as c oncluded 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-re lated diseases has increased si gnificantly in recent years, 
partly as a result of more activ e private-sector and catalyst init iatives such as public-private 
partnerships (PPPs) and product development part nerships (PDPs). Overall, there is still a 
90/10 gap, while health dispari ties between and within countri es are widening. North-South 
research partnerships must be designed in equitable fashion a nd funding needs to be sustained 
beyond the often short-term investme nt in a research project.  
Further investment in research remains nece ssary, but the results must reach low-income 
countries as well. Local owners hip, training and reten tion 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 publ ic health and health systems, poverty-related 
diseases, or neglected infectious diseases research. The programme is focusing strongly on 
supporting the research necessary to achieve th e health-related millennium development goals 
(MDG). 
 
Specific International Co operation Actions: SICAs  
One of the objectives of EU in ternational 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 a nd emerging economies, by means of dedicated 
cooperative activities. SI CAs are restricted to non-associ ated non-EU countries and respond 
to their mutual interest in cooperating on partic ular topics selected on the basis of their 
scientific and technological leve l and needs. Identification of sp ecific needs and priorities is 
closely linked to relevant bilateral coopera tion 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 in cluding ICT for health (eHealth), maternal and 
child health, reproducti ve health, control and surveill ance 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 fo r the European and De veloping Countries 
Clinical Trials Partnership (EDCTP) in res ponse to its achievements and future needs. 
                                                
 
25 Global Ministerial Forum on Research for Hea lth: ‘The Bamako Call to Action on Research for 
Health’, Bamako, Mali, 17-19 November 2008. 
 
EN 12   EN  
International public heal th and health systems  
The focus of research relating to internationa l public health and health systems has direct 
relevance to the international dimension of th e public health policy of the European Union by 
contributing to health protection, prevention a nd promotion, while at the same time generating 
new knowledge relevant to hea lth, social, environmental and economic issues. Taking cross-
sectoral and multi-disciplinary approaches, this re search contributes to initiatives such as the 
millennium development goals (MDG), the Ministerial declarations on global health research
26 and the European policy coherence framew ork for development, with particular 
emphasis on attaining the health  MDGs, including child, mate rnal and reproductive health. 
Such research also contributes  to building the evidence base on health workforce management 
and international migration. The plan is to fo cus a new strategic heal th research agenda on 
better health systems performance and more ef fective preventive public health interventions 
and providing input for future EU development c ooperation. This is reflected in the fourth call 
for proposals which included, in particular, a sp ecial call on Africa. Under the international 
cooperation (INCO) in the Sixth Fram ework Programme (2002-2006), some €  34 million was 
provided to support 20 projects on health financ ing, access to healthcare, quality management, 
health migration and reproductive health. A comprehensive review, covering 43 FP5 and FP6 
health systems research projects, confirme d 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 coll aboration between the EU and Latin America 
in the areas of patient safet y, transfer of technology, and al ert and decision support systems 
based on grid capabilities. The focus of th is collaboration is on optimising the use of 
biomedical data and computing resources. 
   HIV/AIDS
 
In the Sixth Framework Progr amme (FP6), the European Commission funded 41 projects on 
HIV/AIDS, with a total EU c ontribution of more than €  123 million. In particular, support was 
given to research on (a) therapeutic appro aches (drugs, RNA interference, therapeutic 
vaccines based on apoptotic T cells and ot hers) with an EU contribution of €  52 million; 
(b) vaccines (mucosal vaccine s, vaccines targeting dendri tic cells and DNA vaccines, new 
antigen design and delivery systems)  with an EU contribution of €  49 million; 
(c) microbicides (design of new molecules and use of anti-retr oviral drugs to inhibit HIV 
replication in vaginal mucosa) with an EU contribution of €  22 million; and (d) studies on 
cohorts of HIV-infected adu lts and children to investigate insurgen ce of resistance to 
marketed anti-HIV drugs and mother-to-child virus transmission. Many of the translational 
research projects in FP6 included phase I c linical trials. In th e Seventh Framework 
Programme (FP7), 14 projects had been funded by December 2009 with a total EU 
                                                 
26 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. 
27 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 13   EN contribution of about €  70 million, of which €  32 million went to vaccines, €  12 million to 
microbicides, €  22.5 million to treatment and about €  5 million to basic research and training. 
These 14 projects covered: study of vacci nes, inducing broadly- reactive neutralising 
antibodies; a platform to support harmonisation of vaccine adjuvant testing; mucosal and 
transcutaneous vaccines and translational vacci ne research (allocating funds for phase I and 
IIa clinical trials); drug disc overy and pre-clinical developmen t; and paediatric formulations 
of drugs.  
   M a l a r i a
 
Under FP6, 17 malaria research project s 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 basi c research network (NoE ) on malaria, (b) an 
integrated project to develop new antimalaria l drugs and (c) the Euro pean Malaria Vaccine 
Development Association, an integrated project that builds on the European Malaria Vaccine 
Initiative (EMVI) initi ated under FP4 and part-funded by Me mber States. In this way, a 
critical mass of European malaria research wa s 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 fi eld of malaria research needs to  be consolidated where major 
structural malaria projects ar e 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 
specific programmes with a total of €  76 million granted up to December 2009. Seventeen 
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 th e ‘People’ programme. The main  areas funded by the EU from 
2007 to 2009 were basic research (€  24 million), vector control research (€  17 million), 
vaccine development (€  11 million), drugs (€  8 million) and dia gnostics research (€  2 million). 
 
Tuberculosis  
Many of the research projects s upported by the EU on tuberculos is (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 th e spread of antimicrobial  resistance has rendered 
most current drugs ineffective against some TB st rains. Large-scale translational projects have 
proved useful for bridging the gap between di scovery and application and even larger 
initiatives can be expected in the future. 
Research of relevance to TB has been s upported throughout the Framework Programmes, 
albeit sporadically in the early FPs. Unde r FP5 (1998-2002), the EU took a more dedicated 
approach to this area, with funding of €  30 million. The projects funded covered a wide range 
of activities, from basic research, e.g. on mucosal immunology, structural and functional 
genomics, host-parasite relations hips 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 translati onal research, particularly in three 
integrated projects (with an EU contribution of €  11 to 17 million each) addressing vaccine 
development, drug development and mucosal vacci nes. 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 14   EN vaccines against TB. Despite the sc ientific 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 clini cal 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 inf ectious diseases (NIDs), the Se venth 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 invol ving African research groups. 
Scientific and technological cooperation betwee n the EU and developing countries began in 
1982 with three successive Science and Technology for Development Programmes. Then 
1984 saw the launch of internatio nal scientific cooperation ba sed on bilateral agreements 
between the EU and non-EU countries. FP4 (1 994-1998) introduced the INCO (INternational 
COoperation) programme, which became one of the few international funding instruments 
focusing on research to control neglected infec tious diseases. Twenty-s even 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 co untries 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 little -known diseases, including leishmaniasis, 
schistosomiasis, lymphatic filariasis, onchocerciasis, trypanosomiasis, dengue and 
haemorrhagic fever, echinococcosis, buruli ulcer and other childho od infections. Work 
included vector control, vaccines and developmen t of innovations like traps for tsetse flies 
and solar-powered disinfection of drinking water.29 
FP7 is focusing more on applying new modern research methods and technologies to develop 
new medicines and prophylactics ag ainst these diseases. The aim is  to establish an integrated 
approach to development of preventive, therap eutic and control tools based on collaboration 
between European and interna tional partners, including resear chers from countries where 
these diseases are endemic. Activities in this area include, to give just a few examples, parasitic diseases caused by trypanosomatidae sp ecies (e.g. trypanosomiasis, Chagas disease 
and leishmaniasis), bacterial diseases such as  Buruli ulcer, leprosy and trachoma, helminth 
diseases such as schistosomiasis, filariasis a nd other neglected infectio us 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 th ese diseases are endemic and, where relevant, industry, is 
strongly encouraged, including, wh ere applicable, technology tr ansfer, training activities and 
human capacity-building. 
 
European and Developing Countries C linical Trials Partnership (EDCTP)
  
                                                 
28 Lang, H., Quaglio, G.L. and Olesen, O.F.: ‘Tuber culosis research in the European Union: Past 
achievements and future challenges’. Tuberculosis (2010) Vol. 90.1: 1-6. 
29 For further details see: ‘Final Report Internatio nal 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 . 
 
EN 15   EN The European and Developing Countries Clinical  Trials Partnership was set up in 2003 as a 
European response to the global health cris is caused by the three main poverty-related 
diseases — HIV/AIDS, ma laria and tuberculosis.30 Fourteen EU Member States together with 
Norway and Switzerland have pledged €  200 million for this part nership, which will be 
matched by €  200 million from the EU Framework Programme. Essentially, EDCTP provides 
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 suita bility 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 stan dards of regulations and ethics in the c ountries concerned. 
Clinical trials can be a bottleneck if there is not enough financial s upport or capacity. EDCTP 
aims to bridge these gaps. 
EDCTP supports multicentre projects which combine clinical trials, capacity-building and 
networking. The aim of integrat ing 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 f acilitates north-south 
technology transfer and south- south mentorship, allowing dissemination of the capacity 
developed and building up criti cal mass. In addition, the pa rtnership supports Africa’s 
capacity for ethical reviews, regul atory frameworks and clinical trials registration for health 
research. Such support includes grants to esta blish and strengthen institutional and national 
ethics committees and enable them to become  functional and independe nt. Support is also 
provided for strengthening and ha rmonising national regulatory authorities and to improve 
registration of clinical  trials in Africa by means of th e recently established Pan-African 
Clinical Trials Registry. EDCTP also suppor ts various types of training on ethics and 
regulatory frameworks and is mapping the et hics 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 ex cellence 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 institutio ns with varying but complementary capacity 
which work in synergy to conduct clinical tria ls and provide training, south-south mentorship 
and capacity-building in Africa. EDCTP unites th e 14 participating EU Member States plus 
Norway and Switzerland with su b-Saharan African countries.  The partnership helps EU 
Member States to integrate and coordinate their own nati onal research and development 
programmes and form partnerships with their African counterparts.  
After a slow and cumbersome start-up phase, wh en EDCTP had to set up  its own guidelines, 
regulations and governance struct ure 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 developm ent 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 16   EN advisory structure for scientific and strategic matters and an efficient secretariat.31 To date, 
EDCTP has funded 168 projects valued at over €  300 million and involving 135 institutions 
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 extens ion until September 2010. As required by 
the Decision setting up EDCTP, in June 200 9 the Commission initiated an independent 
external evaluation of its activ ities over the period 2003-2008. Base d 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 Afri ca to other countries where diseases are 
endemic) or in terms of the diseases addresse d (to neglected diseases) and types of clinical 
trials supported (to phases I and IV).  
 
Innovative Medicines Initiative  
The EU and the European Federation of Pharma ceutical Industries and Associations (EFPIA) 
have established a new, non-profit body, the Innovative Medicines Initiative (IMI) joint 
undertaking (JU).32 This pan-European collaboration br ings together large biopharmaceutical 
companies, small and medium-sized enterprise s (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 devel opment process by taking a 
coordinated approach and supporting pre-competitive pharmaceutical research and development. It also aims at increasing th e research investment in the biopharmaceutical 
sector in the EU by pooling resources and fo stering 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 gran ts to European public-p rivate 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 
period 2008-2017 is €
 2 billion (€  1 billion from the EU in cash and €  1 billion in-kind 
contribution from industry). The first call fo r proposals was published in April 2008. A total 
of 134 proposals were submitted, of which 15 were selected to receive €  246 million. The first 
call focused on non-communicable diseases that are particularly prevalent in Europe. The 
second, published in November 2009, includes dia gnostics for tuberculosis and pneumonia, 
which place a particularly heavy dise ase burden on low-income countries. 
The IMI research agenda was established under the leadership of industry following intensive 
consultations with a broad range of stakeholders from across Eur ope. It identifies the principal 
bottlenecks in biopharmaceutical R&D and ma kes recommendations to overcome them 
focusing on four areas:  
                                                 
31 Communication from the Commission on the Progress Report on the ‘European and Developing 
Countries Clinical Trials Partnership’ Programme, COM(2008) 688 final. 
32 Council Regulation (EC) No 73/2008 of 20 Decembe r 2007 setting up the Jo int Undertaking for the 
implementation of the Joint Technology Initiative on Innovative Medicines. 
 
EN 17   EN • 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 mi ght produce a change in function. 
• Knowledge management: this underpinning th eme addresses more effective use of 
information and data for predicting safety and efficacy. 
• Education and training: this second underpin ning 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 su ch research will be available to many developers rather than 
being the property of ju st one company. Due to the public nature of su ch research findings, 
important basic research would otherwise be underprovided. Advances achieved by 
precompetitive research platforms will be usef ul for developing a range of medical products 
in that particular medical area, but might not be for different di seases. 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 knowle dge 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 developi ng countries. The discussi ons at global level are 
shaped by the WHO Global Strategy and Plan  of Action on Public Health, Innovation and 
Intellectual Property (see secti on 1.2) which stresses that fu rther sustainable funding is 
essential to support the long-term efforts requi red to meet the health needs of developing 
countries. The WHO subsequently set up an e xpert working group that examined current 
financing and coordination of research an d development and proposals for new and 
innovative sources of financing to stimulate re search and development relevant to developing 
countries. Its report will be discussed by the World He alth Assembly in May 2010.33 In any 
event, effective mechanisms to fund research  must be further expl ored, 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) n eeds to be continuously evaluated. 
 
2.3. Equitable access to knowledge a nd implementation of results 
Whether science can help to improve health at global level depends not only on whether 
relevant research will in fact be undertak en, 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 a nd 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. 
 
EN 18   EN policies can only be grounded in country-led research and learning that can be backed up by 
global support. This requires domestic leadersh ip and sustained invest ment in local capacity-
building for analysis and learning, robust syst ems 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 th at offer universal and equitable access with 
the necessary inputs (financi ng, human resources, supplie s, information technology, 
governance, etc.) that are based on the best evid ence available and respond to local needs and 
realities. The inadequate access to medical in novations 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 lite rature by research communities in developing countries. Rising 
costs of subscriptions and perm ission barriers imposed by publishe rs 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 underprovide d otherwise — due to its  nature as a public 
good, then the results of the research should b ecome 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 re search 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 devel oping local scientific capacit y. The considerable but very 
different support offered by development assist ance and the Framework Programme makes it 
difficult for national research policy and hea lth policy-makers to create sustainable 
programmes. Official development assistance of ten gives priority to primary, secondary and 
vocational education, which is key to ensuring employability. In additi on, the EU strategy for 
Africa of 2005
36 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. Th ere are now opportunities for collaboration 
between higher education institutions under the education programmes Erasmus Mundus Programme
37, Edulink38, and the Mwalimu Julius Nyerere programme39. The FP7 special call 
                                                 
34 Yamey, G.: ‘Excluding the poor from accessing biomedical literature: a rights violation that impedes 
global health’, Health and Human Rights 2008:10. 
35 Commission Decision C(2008) 4408 final, 20.8.2008. 
36 COM (2005) 489 
37 Decision 1298/2008/EC, 16 December 2008. http://eacea.ec.europa.eu/erasmus_mundus/  
38 http://www.acp-edulink.eu/   
39 http://ec.europa.eu/development/policies/9interventionareas/humandev/humandeveduc5_en.cfm   
 
EN 19   EN on Africa40 paid particular attention to research capacity building and training. Howver, 
competitive research calls are looking for scientif ic excellence, which can be difficult to build 
up and sustain without considerab le 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 coopera tion is possible and fruitful only if sufficient scientific 
expertise is available in the partner country to enable bila teral learning. The benefits of 
regional cooperation on resear ch have been realised in  the EU and supported by the 
Framework Programme. The EU would be best pl aced to provide assistance for establishing 
regional or south-south partnerships for res earch. 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 innov ation in health products that addresses African 
public health needs by putting together resear ch 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 de livered effectively and 
applied in clinical practice. Building up this knowledge base with th e 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 h ealth and health systems. 
Most researchers who propose to develop and test  disease control methods either explicitly or 
implicitly intend to promote efficacious interv ention 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 or iginally tested. For many years, health 
researchers tended to assume th at 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 fu nding research on implementation addressing the degree to 
which health intervention can fit into real-wor ld public health and clinical service systems. 
 
2.3.4.  Translation of knowledge into po licies (health services research) 
Health services research is a multidisciplinary fi eld of scientific investigation that studies how 
social factors, financing system s, organisational structures and processes, health technologies 
                                                 
40 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. 
41  http://andi.tropika.net/   
 
EN 20   EN and personal behaviour affect access to healthca re, 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 Euro pean 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 th e evidence-base by means of 
comparative health systems research that can th en be used by national decision-makers when 
they reform their health system. This knowledge  is necessary in orde r truly to learn from 
successes and failures in healthcar e delivery in other countries, be they in Europe or beyond. 
That is why this form of research collabo ration may include partners from developing 
countries and regularly target i ssues particularly relevant to  developing countries’ health 
systems in specific internati onal cooperation activities. 
 
3. Conclusions 
The European Union can play a key role in addressing the weaknesses that are currently 
preventing realisation of the fu ll and equitable benef its that research can offer for global 
health. The EU institutions and the existing struct ures 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 de scribed above could enhance the EU response 
proposed in the Communicati on in the following ways: 
In order to coordinate more effectively EU rese arch for global health that benefits the health 
of all people, the existing str ong institutional links in the EU could serve to define a common 
EU position on the research priorities, the distri bution of research between various entities, 
sectors and geographical areas, and the financ ing of research and development. Global 
coordination of these issues w ill not be realistic without a st rong European voice and common 
position. The EU in general and the European Commission in part icular 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 re search consortia in the ‘Coope ration’ programme, addressing 
research topics that are often beyond the remit of  national research cons ortia alone, could be 
harnessed to foster sustainable global coll aboration on health research. Building on the 
existing research collaboration on poverty-rela ted diseases and expertise in comparative 
health systems research, the European exper tise in research on non- communicable diseases 
could be an additional driver for international scientif ic cooperation on global health. The 
impact of the innovative partners hip instruments that the EU ha s established with the private 
sector (IMI JU) and developing countries (E DCTP) will be evaluated, as required by the 
decisions establishing them. Maki ng these initiatives more effec tive will provide the EU with 
powerful and innovative tools to support gene ration of new knowledge relevant to global 
health and also to build in the need for e quitable access to innovative products and treatments 
embedding that new knowledge. The IMI Joint U ndertaking should continue to include pre-
competitive research that is relevant to diseas es with an impact on global health. EDCTP has 
the potential not only to support th e crucial but expensive clinical trials that ar e necessary to 
develop drugs or medical devi ces relevant to health in Africa but also to extend the 
partnership and joint learning to other di seases and other developing countries. 
The EU should strengthen and balance the comp lete health research process of innovation, 
implementation, access, monitoring and evaluation;  and inform health policies, including the 
 
EN 21   EN development of national research capacities. Implementation of new knowledge and equitable 
access to innovative products and treatments need s to be built into the entire innovation 
process in order to provide meaningful result s for global health. This implies evaluating and 
addressing the impact of IPR on global health. Th e 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 dis eases, not only collaborati on on pre-clinical and 
clinical research seems pertinent, but also cl oser international colla boration on regulating the 
market for rare or other neglecte d 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 evid ence-base for national decision-
makers when they build or refo rm their health systems so that they can provide services 
effectively to the population th at 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 a nd health research in developi ng countries and to invest in 
sustainable structures to s upport this capacity-building. Coor dination between the various 
instruments that the EU has at its disposal , particularly the European Development Fund 
(EDF) and the Framework Programme for Res earch, will create s ynergies 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 (eH ealth). Decisions in 
managing health care or health care system s should be based on the best information 
available. EHealth solutions offer great poten tial 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 in formation systems in the EU has improved the 
comparability of such data and consequently its value for decision makers in the Member 
States. Closer global coordinati on of health information system s would reduce the burden of 
the different reporting requireme nts and enhance the opportunities  for joint lear ning. Reliable 
and comparable health statistics at global leve l are an important cornerstone of effective and 
equitable global policies for health.