EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 26.10.2004 
COM(2004) 726 final 
.   
COMMUNICATION FROM THE COMMI SSION TO THE COUNCIL AND 
THE EUROPEAN PARLIAMENT 
A Coherent European Policy Framework for Ex ternal Action to Confront HIV/AIDS, 
Malaria and Tuberculosis 
 
   
{SEC (2004) 1326 } 
 
EN 2   EN TABLE OF CONTENTS 
1. Introduction................................................................................................................ .. 3 
2. Challenges.................................................................................................................. .. 3 
2.1. Epidemiological, geographical a nd demographical challenges ................................... 3  
2.2. Challenges to maintain a comprehensive policy mix of prevention, treatment 
and care ....................................................................................................................... .4 
2.3. Challenges in financing................................................................................................ 4  
2.4. Challenges in governance at country and global levels ............................................... 5  
3. EU vision................................................................................................................... ... 6 
3.1. Vision for 2015 ........................................................................................................... .6 
3.2. Principles................................................................................................................ ...... 7  
4. EC added value and EC actions ................................................................................... 7  
4.1. EC added value ............................................................................................................ 7 
4.2. EC action at country level............................................................................................ 8  
4.2.1. Increase capacities..................................................................................................... ... 8 
4.2.2. Increased and sustainable resources............................................................................. 9  
4.3. EC action at global level ............................................................................................ 10  
4.3.1. Affordable and safe pharmaceutical products............................................................ 10  
4.3.2. Regulatory aspects ..................................................................................................... 1 0 
4.3.3. New tools and interventions....................................................................................... 11  
4.3.4. Strengthened partnerships a nd a strong European voice............................................ 11  
5. EC tools.................................................................................................................... .. 12 
6. Conclusion.................................................................................................................. 12 
 
EN 3   EN 1. I NTRODUCTION  
In 2000, Europe made a commitment to achieving the Millennium Development 
Goals (MDGs) and the European Union (E U) adopted its new development policy, 
based on poverty reduction. At the same time, the Eu ropean Commission (EC) 
developed a comprehensive frameworki to accelerate action ta rgeted at the three 
major poverty diseases – HIV/AIDS, malari a and tuberculosis (TB). The Programme 
for Action (PfA),ii developed as a framework for implementation, remains just as 
valid today. The status of the PfA is illustrated in the progress report 2004.iii 
Significant achievements have been made on impact, affordability and research and 
development through coherent  action between the policy ar eas of development, trade 
and research. 
The EU needs to accelerate action and addr ess issues where progress has been slow. 
While maintaining the overall goal of poverty reduction, the EU also needs to 
respond to an increasingly changing global aren a and rise to new ch allenges. There is 
a growing awareness of the effect that HIV/AIDS can have on human security and 
human rights. The changing nature and rapi d spread of HIV/AIDS and TB globally 
also warrant consideration. Sustaining policy coherence re garding HIV/AIDS, 
malaria and TB remains a major challenge. 
This Communication provides the policy fram ework for all EC external action on 
confronting the three diseases. The Co mmunication has been prepared following 
stakeholder consultations with third count ries, EU Member States, civil society, 
industry, the Global Fund to Fight AIDS , TB and Malaria (the Global Fund), UN 
agencies, the World Bank and others. A stakeholder consultation meeting was 
organised in Brussels on 14 September 2004.iv Due to the re-emerging epidemic in 
Europe and its neighbouring countries, the Commission has highlighted the need for 
immediate action through a separate Working Paper adopted by the Commission on 
8 September 2004. This proposes a set of c oncrete actions for the next eighteen 
months.v These actions and recommendations to  partners were endorsed in the 
“Vilnius Declaration” adopted by participan ts in the Ministeria l Conference “Europe 
and HIV/AIDS: New Challenges, New Oppor tunities” (Vilnius, 17 September 2004). 
2. C HALLENGES  
2.1. Epidemiological, geographical and demographical challenges 
Despite increased efforts and resources, the number of people affected, infected and 
dying from HIV/AIDS, malaria and TB conti nues to rise. More than 6 million people 
in the world die each year from the three di seases, and the effectiveness of treatment 
is threatened by the emergence of multi- drug resistant malaria and TB. HIV/AIDS 
and TB are spreading rapidly, includi ng in (European Neighbourhood Policy) ENP 
partner countries (e.g. Russia); the number of people with the diseases in countries 
with large populations (e.g. China and Indi a) is increasing. Ma laria poses a large 
burden particularly on African countries. Sub-Saharan Africa con tinues to carry the 
largest burden of HIV/AIDS and is home to two-thirds (an estimated 25 million people) of HIV-infected people globally.
vi 
 
EN 4   EN Particularly with regard to developing countries, poverty reduction remains the main 
framework in which to confront the thr ee diseases, as the diseases are often a 
consequence and a cause of poverty. HIV/ AIDS, malaria and TB have a negative 
impact on the social and economic fabric of communities. The critical interaction between human security issues and the wi der Cairo agenda (including HIV/AIDS, 
and gender-based violence) is becomi ng increasingly obvious. This demands 
consideration of human securi ty and human rights. The spread of the three diseases 
among refugees and people living in conflic t situations remains a challenge. The 
HIV/AIDS pandemic continues to affect women disproportionately in terms of 
infection rate, impact and lack of acce ss to prevention, treatment and care. 
Consideration of vulnerable children, including the 12 million AIDS orphans in Africa, remains a challenge. 
2.2. Challenges to maintain a comprehensiv e policy mix of prevention, treatment 
and care 
HIV/AIDS, malaria and TB can be prevented and treated, but more countries need to 
develop appropriate strategies with a co mprehensive policy mix integrating proven 
prevention, care and treatment. Successful programmes contain a balanced response. 
Condom use, and harm reduction programmes including needle-exchange for injecting drug users, have to be promot ed as methods of HIV/AIDS prevention. 
Many health systems are showing signs of weak infrastructures and overstretched 
human resources; given the growing care  and treatment needs for HIV/AIDS, 
maintaining an adequate focus on preventi on and care poses a challenge. Provision of 
treatment requires more predictable and long-term resources. Research into new interventions is needed to deal with changing forms of the diseases. Capacity building for research and health services is  also an integral part of the strategy. 
2.3. Challenges in financing 
Resources allocated to HIV/AIDS have in creased globally, primarily because of an 
increase from domestic budgets and the pr ivate contribution (s ee Annex 1, Table 2). 
There are scant global funding figures  available on malaria and TB. 
Despite the increase, a considerable gap re mains in terms of external resources to 
confront the three diseases (see Table 1). The international community will need to secure appropriate funding to match dema nd.UN estimates of the resources needed 
by region to confront HIV/AIDS over the ne xt few years are give n in Annex 1, Table 
3. However, this Communication does not ha ve financial implications for the EC. 
 
EN 5   EN Table 1 – Estimated annual ODA and external resource gapvii 
  
 
0 0,5 1 1,5 2 2,5 3 3,5 4 4,5 
HIV/AIDS Tuberculosis MalariaIn US$ billion  
Resource gap in  
external financing  
Resource availability of  
ODA
 
2.4. Challenges in governance at country and global levels 
Reaching the affected countries, the poorest pe ople, and the disenfranchised of 
all societies  remains a challenge. Populations al ready facing barriers to care (in 
particular women and the poor) have b ecome increasingly marginalised. Many 
behaviours associated with increased risk  of HIV/AIDS (e.g. men having sex with 
men, injecting drug use, commercial sex wo rk) are often socially  unaccepted; people 
living with HIV/AIDS and TB  are often met with stigma  and discrimination. This 
prevents open dialogue, and can lead to poor access and uptake of prevention 
methods, testing and treatment. Enabling youth, women and people affected by the 
diseases to have a stronger voice in planni ng, policy and implementation is crucial to 
address needs. 
Strong leadership within count ries is esse ntial, with political commitment  behind 
effective policies and consequent mobilisation of resources. Particularly in many of the poorest countries with weak  government structures and in ENP partner countries, 
the acknowledgement among political leaders of the need to address HIV/AIDS and TB is a challenge. 
The fact that the three diseases know no inst itutional or national boundaries  is 
another challenge. Confronting them require s strong cooperation be tween all partners 
in society. Some countries have managed to  establish cross-sector al cooperation with 
concrete results. The Country Coordina ting Mechanisms (CCMs) set up to access 
Global Fund support can play a strong ro le in catalysing cooperation between 
different partners, promoting harmonisa tion and facilitating implementation. 
Confronting the three diseases often requi res a cross-border response, which is 
difficult where regional in stitutions are weak. 
Increasing the efforts of the private sector  to supply resources and skills is a major 
challenge. The private sector  has significant untapped potential to invest in 
developing countries. Increasing private sector efforts in the area of tiered prices on 
their products, and in their contribution to multilateral initiative s (e.g. the European 
and Developing Countries Clinical Tria ls Partnership (EDCTP) and the Global 
Fund), remains a challenge. 
 
EN 6   EN The lack of vocal representation and the imbalance of power on global issues also 
represent a challenge in terms of global governance on health . Many countries do 
not have the voice, negotiati on capacity or voting right s to design and implement 
global rules to their advantage (e.g. rega rding research priorities and regulatory 
frameworks). The increase in the number  and diversity of global initiatives and 
players in the HIV/AIDS, ma laria and TB arena has further altered the global 
institutional structure, and poses oppor tunities and challenges in terms of 
harmonisation and coherence. The recent enlargement of the EU has brought the 
impact of HIV/AIDS and TB in ENP partne r countries in Easter n Europe higher on 
the European agenda. 
3. EU  VISION  
3.1. Vision for 2015 
The EC will continue to res pond to the evolving nature of the three diseases and their 
geographic spread in developing countries and in ENP partner countries. The EC and 
the EU Member States have made intern ational commitments and share a long-term 
vision towards confronting the three diseas es and reaching the MDG target date of 
2015. Through its humanitarian aid, development,  trade, health and external relations 
policies, the EU contributes to achieving the MDGs , including MDG 6 on 
“combating HIV/AIDS, malaria and other diseases”. 
All EU Member States endor sed the Programme of Action adopted in Cairo in 1994 
at the International Conf erence on Population and Deve lopment (ICPD). The Cairo 
agenda on sexual and reproductive health and rights  (emphasising a voluntary, 
people-centred approach based on informed  choice) is clearly reflected in EU 
policies and advocacy positions. The EC and the EU Member States were signatories 
to the Declaration and Platform for Ac tion of the 1995 World Conference on Women 
in Beijing. The Platform stressed the need for action against world-wide obstacles to 
gender equality , and established gender mainst reaming as a main strategy.viii All EU 
Member States have ratified the UN Convention on the Right s of the Child. The 
commitment to human rights  is also clear in the EC Development Policy 
Statement.ix The commitments to MDGs, Cairo, Beijing, human rights and human 
security are core pillars of the EU vision for confr onting the three diseases. 
Increasing resources and coordinating effort s are also part of the EU vision. The 
0.7% of gross national income (GNI) rema ins a recognised target for EU Member 
States’ allocations to ODA. The EU is we ll on track to achieving commitments made 
in Monterrey (March 2002);x based on current trends, the EU will provide 0.42% of 
its collective GNI in ODA by 2006 (€38.5 billion).xi This means an increase of €10 
billion per year of EU ODA. The EC a nd the EU Member States are bound by the 
Treaty to operate in coordination and complementarity  in the field of development 
cooperation, a commitment r eaffirmed at the High-Level Forum on Harmonisation in 
Rome (2003). The principles of harmoni sation across strategy, agency and 
monitoring plan are also reflected in  the 3 Ones approach to HIV/AIDS.xii 
 
EN 7   EN 3.2. Principles 
Several shared principles guide Europe’s cooperation with thir d countries. The EU 
closely adheres to the ov erall developm ent goal of reducing poverty , achieving the 
MDGs and respecting rights. The principle of  equity means that services need to 
reach those who are most in need. Ensuring countrywide ownership remains a 
guiding principle. Countries remain th e key decision-makers responsible for 
formulating their strategic priorities a nd national frameworks. Governments are 
accountable  to their electorates for their choices and for implementation. Good 
governance , with the ability to ensure transparen t processes and maintain the rule of 
law, is an integral part of  country action. Governance beyond  state institutions is also 
important to ensure demand-driven responses with broad participation , including 
civil society and the private sector. Worki ng with third countries also requires the 
scaling-up  of actions, and increasing sustaina ble resources, with complementary 
investment in enhanced capacity. 
4. EC  ADDED VALUE AND EC ACTIONS  
4.1. EC added value 
As seen from the progress report and consu ltations, the EC has several attributes of 
comparative advantage for action on the three diseases. The majority of EC financial 
support instruments are, and w ill remain, at country level. The EC, together with the 
EU Member States, will also continue to  address key issues at global level. 
The EC has successfully cooperated ac ross policy areas of development, 
humanitarian aid, trade, and research towards coherent external action . Activities in 
different policy areas can reinforce each ot her and produce greater synergy. This is 
the added value of the EC, and goes beyond what EU Member States can do individually (as has been evident from implementation of the PfA, and advocacy for 
ICPD and the Doha Declaration on TRIPs a nd public health). The EC also has added 
value in its ability to convene, represent and defend a common European position 
globally , thus improving coherence in global governance. Coherence between EU 
Member States and the EC will become increasingly important. Human security, including the links with HIV/AIDS, is an important consideration in the evolving 
field of a Common Foreign and Security Policy. 
At country level, EC added value includes its working presence in many 
countries,
xiii including several neighbouring co untries and those where some EU 
Member States are absent, as well as  the ability to provide support for recurrent 
costs , e.g. salaries of health staff and co mmodity purchasing – a major component of 
health expenditure. 
A final aspect of added value is the flex ibility in the current EC thematic budget 
lines, which allow for the financing of innovative actions  both at country and at 
global level. This has allo wed for support to the Global Fund, to the International 
AIDS Vaccine Initiative (IAV I), to the International Partnership for Microbicides 
(IPM), and to the EDCTP sites for clinical trials in dis ease-endemic countries. Such 
flexibility should be retained in the new fi nancial instruments for EC external action 
(2007-2013). 
 
EN 8   EN 4.2. EC action at country level 
The geographic spread of the diseases re quires a focus beyond developing countries. 
In particular, multi-drug resistant TB a nd HIV/AIDS are spr eading fast in ENP 
partner countries. The EC is able to provi de a policy mix of c ountry support through 
various financial instruments and for different  social services; a country can ask for a 
different range of inputs depending on its needs. The poorest countries  need the 
most financial resources, resources rela ted to political commitment, technical 
capacity building, and policy dialogue, and close partnership. Middle-income 
countries , including the new neighbouring countries in Eastern Europe  mostly 
need support in their policy dialogue and political commitment, and in technical 
capacity building. In areas of difficult partnershipsxiv (commonly characterised by 
human rights violations, politic al repression, high levels of corruption, or violent 
conflict), the EC will remain engaged and adopt specific strategies such as LRRD and working pragmatically with committed organisations inside and outside of government. 
4.2.1. Increase capacities 
The EC will actively focus on enhancing human resource capacity in national 
development plans, such as the Country Strategy Papers (CSPs), Partnership and 
Cooperation Agreements, and Poverty Re duction Strategy Papers. This will 
strengthen social services, including health and education. Improving human 
resource capacity includes accelerated ac tion on staff training, career development, 
appropriate remuneration and retention of staff, and responsive management. These 
actions will address some of the key motiva tional problems faced by health staff, and 
might therefore dent the drasti c brain drain of staff from rural to urban, from public 
to private, and from developing to de veloped countries. The EC recommends 
countries and donors to agree on a financing model where disease-specific initiatives 
contribute a defined pr oportion of their funds to health  care delivery, including the 
development of human resources. The EC could also explore a European code of 
conduct for recruiting staff from third c ountries; or for organisations employing 
national staff to train count erpart staff within the gove rnment structure. These 
proposals should be further developed in the High-Level Forum on Health. 
The EC encourages capacity enhancement of broad-based national and regional 
(e.g. NEPAD) bodies  focusing on the three diseas es with participation of 
government and non-government stakeholders  at country level (e.g. CCMs where 
they are present). EC delegations will be more actively involved in capacity building and establish complementary partnerships wi th EU Member State representatives to 
provide technical assistance. 
In its policy dialogue, the EC  will encourage countries to  develop strategies which 
recognise the value of investing in people and in social services . A comprehensive 
policy mix, including preven tion, treatment and care, is necessary. An appropriate 
mix depends on the nature of the disease, cap acities and resources available, and best 
practice. For HIV/AIDS, evidence shows that condom use and open discussion of 
sexual activity – rather than abstinence – ar e the most effective tools for preventing 
sexual transmission. A recen t study on India illustrated
xv that increasing the current 
rate of condom use during high-risk contacts from 50%  to 70% would be enough to 
change the direction of the epidemic in India. 
 
EN 9   EN The EC will strengthen surveillance and monitoring capacity of  health outcomes  
through continued support of the Health Metrics Networkxvi and UNAIDS. The EC 
will emphasise the tracking of health data  beyond the currently used ten MDG-linked 
core indicators. It will become increasingly important to demonstrate that macroeconomic support allows countries to a ddress priorities in social services. The 
EC will work with EU Member States to assess whether macroeconomic support 
allows for increased resource flows to social services, and whether this translates into 
improved health outcomes. 
The EC will focus on the critical interaction between human security and the Cairo 
agenda  in discussions with personnel participating in conflict-resolution, peace-
keeping and post-conflict operations. The full Cairo agenda – including HIV/AIDS, 
gender-based violence and provision of contr aceptives – needs to be an integral part 
of the analysis of conflicts, thei r causes, effects and resolution. 
The EC will support local production capacity , e.g. for raw materials and 
formulations of artemisinin-based comb ination therapies (ACT) and other new 
antimalarials, insecticide-treated bedne ts, condoms, and generic production of 
essential drugs – including fixed-dose comb inations (FDCs) for TB and HIV/AIDS. 
Local production can promote competition and make pharmaceutical products more affordable. It is important to encourage te chnology transfer to ensure that locally 
produced pharmaceutical products meet inte rnationally agreed standards. The EC 
will pursue this through cooperation with  the European Investment Bank. 
The EC will continue to strengthen developing countries’ capacities to conduct 
research, particularly in clinical trials. Synergies between capacity building for 
research and training of staff for healthcar e services should be explored, with the 
active involvement of partner countries. The EDCTP s hould play an integrating role 
by contributing to both natio nal and regional human re source plans for clinical 
research. 
4.2.2. Increased and sustainable resources 
Countries need increased long-term, sustainable resources , from a variety of 
sources, to confront the thr ee diseases. Countries need to invest an appropriate 
portion of their budget in social services to achieve improved health outcomes. The 
WHO-World Bank Commission on Macroecono mics and Health recommends an 
annual budget allocation to health of at  least US$40 per capita. The current annual 
gap in reaching this recommendation is over €12 0 billion. Private investment in third 
countries and official development assistance (ODA) are needed.xvii The EU should 
continue to adhere to commitments ma de in Monterrey on raising ODA. The 
capacity of countries to ab sorb increased resources sh ould be addressed, and 
medium-term expenditure frameworks developed that encourage flexibility in investment ceilings. 
The EC will increase funding support to confronting the three diseases through 
innovative action . The Global Fund has proven to be  a comparatively fast way of 
channelling EC funds into c onfronting the three diseases at country level and has 
already shown key results. According to Global Fund projections based on demand 
from the countries concerned a tripling of the annual average level of donor contributions is needed, from the current US$1 billion to US$3 billion by 2008.
xviii 
 
EN 10   EN The need for a substantial EU contributi on, in the region of US$ 1 billion annually, 
has already been discussed at the EU Thessaloniki summit. The 2005 high-level 
replenishment conference of the Global Fund is an opportunity for all donors to 
increase their contributions. If this conference re-confirms the projections made, the 
EU will be expected to contribute to incr eased funding needs. Contributions will be 
expected from both the EC and from EU Member States, based on a model for fair 
European burden sharing. 
4.3. EC action at global level 
4.3.1. Affordable and safe pharmaceutical products 
The EC will continue to advocate a re duction in the price of pharmaceutical 
products. The EC will continue to encourage tiered pricing  through, inter alia , the 
use of the anti-trade diversion Regulation on a broader range of products (including 
anti-retroviral second-line  treatments, FDCs, paediatric formulationsxix and other 
products such as ACTs). The EC encourages competition  between the R&D based 
industry and generic producer s and public tendering base d on fair and transparent 
procurement rules to reduce prices. 
The EC will also en courage countries to publish in a transp arent manner prices  of 
commodities purchased, whether through the Global Fund (where prices paid are 
already made public), or through other mechanisms. This will become standard 
practice for EC-funded programmes pur chasing pharmaceutical products. 
The EC emphasises adherence to the Doha Declaration on TRIPs and public 
health (2001), and to the August 2003 Decision,xx including assurance that the 
Declaration is not undermined either in fo rmal amendments of the TRIPs Agreement, 
through bilateral negotiations , or through national legisl ation. The EC encourages 
developing countries to make use of TRIP s flexibility and exemptions, including 
compulsory licensing while stressing the importance of an adequate intellectual 
property regime. 
The EC will provide techni cal assistance to improve countries’ capacities in 
pharmaceutical policies , including through continued a nd strengthened partnership 
with WHO on prequalification. The EC will c ontinue to emphasise the need for safe 
pharmaceutical products. The EC Enforcemen t Strategy Paper (June 2004) contains 
guidelines for EC action on the enforcement of intellectual prope rty rights in third 
countries, which will be considered  along with public health needs. 
4.3.2. Regulatory aspects 
The EC will support the enhanced capacity of third countries to perform regulatory 
tasks, including the approval of clinical trials and the granting of market 
authorisation. Regulatory ch allenges for new vaccines, microbicides and diagnostics 
need to be addressed.xxi The European Medicines Agency (EMEA) and national 
regulatory authorities in the EU, coul d support – in coordination with WHO – 
capacity building for regulatory bodies th rough partnerships, scientific/technical 
assistance or financial support. This shoul d focus on establishing regional centres of 
regulatory expertise in, for example, Brazi l, South Africa and Thailand. Regulatory 
 
EN 11   EN procedures should not be used as trade obstacles, which could make pharmaceutical 
products more expensive. 
Assistance provided by the EMEA will bu ild on the recent revision of the EU 
pharmaceutical legislation, enabling the EMEA to give a scientific opinion for the 
evaluation of medicines  to be marketed exclusively outside the Communityxxii. This 
procedure, open to both R&D and gene ric manufacturers, should enable the 
Community to provide scientif ic support to developing count ries, thereby facilitating 
rapid access to medicinal products whic h meet their own public health needs.xxiii 
4.3.3. New tools and interventions 
The EC will continue to focus on developing new, effective, safe and affordable 
tools and interventions , by investing in research and development. New effective 
vaccines would be the most powerful and co st-efficient tool to confront the three 
diseases, but a comprehensive research a pproach will remain important, in the 
foreseeable future.xxiv Research in new interventions should focus on vaccines for the 
three diseases, microbicides to prevent HIV/AIDS transmission,xxv new diagnostics 
and treatments for TB in the context of resistance and low compliance, and improved 
prevention and treatment for malaria. Spec ial attention should be given to FDCs, 
paediatric formulations, and treatment regimens for multiple concurrent infections. 
The EC will continue to support EDCTP  in order to increase the number of new 
candidate vaccines and other pr oducts entering clinical tria ls. The EC will encourage 
Member States and industry to invest in and make use of the EDCTP programme. 
The EDCTP will ensure coherence and syner gy between clinical trials carried out by 
itself and by other organisations. 
The results of extensive monitoring in th e relevant social and economic context 
should be used to improve the impact of existing interventions and diagnostic tools. 
Epidemiology and applied research will ther efore be an integrated part of the 
research agenda.  
Following stakeholder consultati ons, the EC will establish incentives  to harness the 
capacity of private industry, including sma ll and medium-sized bi otech enterprises, 
in the development of new tools targeti ng the three diseases. Incentives could 
include: the extension of patent rights a nd/or market exclusiv ity, including through 
the relationship which might be established between di fferent products, simplified 
and faster regulatory procedur es, venture capital, low cost loans, tax credits and 
guaranteed markets. 
4.3.4. Strengthened partnerships and a strong European voice 
The EC will continue to cooperate closely with EU Member States  – on technical 
assistance, strengthening regulatory capacity  in developing countries, and promoting 
and coordinating research. The EC will also continue to seek common European positions in multilateral institutions and mechanisms, including the Global Fund. 
The EC will continue and strengthen policy dial ogue and funding to multilateral 
UN organisations : the strategic partnership with WHO (on pharmaceutical policy, 
regulatory issues, and health monitoring), and the strong partne rship with UNAIDS 
 
EN 12   EN (regarding the 3 Ones) and UNFPA (for the Cairo agenda). This should be seen as 
part of an EC response to the challenge s posed in terms of global governance for 
health. 
The EC will continue to support demand- driven country programmes  through 
the Global Fund (see Annex 2 for more details). 
The EC will continue to s upport a needs-driven global re search agenda by supporting 
the EDCTP and by partnering with  other international research initiatives, such as 
IAVI, IPM, GAVI, and the Global HIV V accine Enterprise (endorsed by G8). 
The EC will continue to present a strong voice advocating common European 
values  at fora following Cairo and Doha, w ith the ultimate goal of achieving the 
MDGs by 2015. 
5. EC  TOOLS  
Coherence remains an integral component of the EC policy framework. Coherence 
and coordination  need to be reflected in the EC institutional set-up, perhaps with a 
clearly defined lead service, to ensure EC -wide accountability. Measures will also be 
put in place to ensure coordination betw een EC services, in cluding delegations, 
responsible for various parts of the pr ogramming cycle. These proposals will be 
developed in more detail in  the Programme for Action. 
The new EC financial perspectives (2007-2013) offer increased opportunities and 
scope for leadership to confront global ch allenges, including the three diseases. The 
new financial instruments benefit the poores t countries, while also  supporting the EU 
neighbourhood. Six instrument s are proposed, three suppor ting EU external policies 
(pre-accession, neighbourhood and development), and three thematic instruments to respond to political, humanitarian and financia l crisis situations (See Annex 3, Table 
4).
xxvi While this Communication does not have  financial implications, a Programme 
for Action will be presented at a later stage specifying actions in various regions and 
proposing resource allocations. 
The EC Round-table discussion in 2000 es tablished a momentum for action between 
different stakeholders. The EC will con tinue to amplify this momentum, and 
establish a Stakeholder Forum  to ensure continued c onsultation, including people 
living with HIV/AIDS, malaria or TB, on how to confront the three diseases and on 
instruments and financing needed. 
6. C ONCLUSION  
The Policy framework (2000) and the Programme for Action adopted in 2001 
achieved significant results in confronting th e three diseases within the context of 
poverty reduction. Much of this was due to  synergy between EC research, trade and 
development policies. Based on these experiences and following consultation with stakeholders, including developing countries and ENP partner countries in Vilnius, a 
coherent policy framework for all EC external  action to confront th e three diseases is 
presented in this Communication. The Communication will be brought before the 
Council under the Dutch Presidency, and submitted to the European Parliament. 
 
EN 13   EN Based on this comprehensive policy framework, new strategies and action 
programmes will be developed. These will re fer to the use of specific instruments 
and resources, and will propose further c oordination with EU Member States. The 
Commission Working Document  prepared for Vilnius already outlines specific 
actions for ENP partner countries in Eastern Europe. 
Europe has a leadership role to play in confronting HIV/AIDS, malaria and TB 
globally. The current EU Presidency (the  Netherlands), and future Presidencies 
(Luxembourg, the UK, Austria and Finland) have given priority to confronting the 
three diseases and adhering to the full Ca iro agenda. Communicable diseases remain 
prominent on the global agenda – in UN fora  and the G8. Europe’s contribution to 
turning the tide of the HIV/AIDS pandemic,  and confronting malaria and TB, will 
help to achieve the ultimate aim of the MDGs – reducing poverty for millions of people worldwide. 
 
EN 14   EN Annex 1: Resources spent, and resources needed, for HIV/AIDS  
Table 2: Resources invested in HIV/AIDS, 1996-2003xxvii 
Resources for HIV/AIDS
Global resources*
ODA**
0500100015002000250030003500400045005000
1996 1997 1998 1999 2000 2001 2002 2003
YearsUS$ MillionGlobal resources*
ODA**
 
Table 3: Projected Annual HIV/AIDS fi nancing needs (in US$ million) by 
region (2004-2007)xxviii 
 
  
 
EN 15   EN Annex 2: The Global Fund to Fight AI DS, TB and Malaria and the EU’s role 
The Global Fund was established to generate additional public and private resources 
to confront the three diseases. It de parts from traditional forms of multilateral 
governance because non-state actors shar e decision-making powers and financing 
responsibilities with national governments. This reflects the polit ical implausibility 
of raising much-needed funds through the UN, while still remaining reliant on the 
infrastructure and support of UN agencies , funds and programmes. For example, 
WHO and UNAIDS are providing technical  aid and administrative support and 
building capacities. The Global Fund was also established to be a model of 
performance-based funding. While not a pur chasing institution, the funding provided 
to support demand-based proposals made by countries, and the transparency in 
purchasing, can help to reduce prices of  pharmaceutical products and commodities. 
The demand generated could also have a medium-term leverage effect on research 
into new tools to confront the three diseases. 
A forecast of the Global Fund operations and the business modelxxix illustrates that, if 
the current business model is pursued, the Global Fund will reach an  annual value of 
approvals, commitments and disburseme nts of US$3 billion from 2008 onwards. 
This forecast predicts a considerable incr ease in both the demand for resources and 
the workload compared to the current levels. Although disbursements have been slow initially, they would speed up over the next three years to meet the level of 
approvals. 
The annual average level of donor contributio ns to the Global Fund would have to 
triple from its current US$1 billion to re spond to the increase in resource demands. 
The 2005 high-level replenishment conference of the Global Fund is an opportunity 
for all donors to increase th eir contributions to the Fund.  As tens of thousands of 
people begin receiving anti-retroviral treat ment financed by the Global Fund, the 
issue of sustainable and pr edictable funding is even more important. Countries 
should gradually move towards self-sustain ing financial systems. However, faced 
with severe resource constraints in the poorest countries, the gl obal community will 
need to continue its suppor t for many years to come. 
Other future challenges to the Global Fund for the EC/EU to take  a position on in the 
Board meetings are the difficulty of some  poor countries to e ffectively use large 
sums of money, especially with the signi ficant brain drain in developing countries, 
which depletes human resources, particularly in the health services most needed. It has also been discussed wh ether the disease-specific approach committing global 
finance primarily to the three diseases, instead of health services, is, in general, beneficial. The Global Fund pr ogrammes have so far been  successful in delivering 
the demand at country level. Some c ountries have even exceeded performance 
targets and disbursements have been made  faster than expected. In a recent 
performance review made by the Global Fund,  the 25 grants that had passed one year 
of operations were performing above the targets set and in comparison with other donors. On average for all grants reviewed, 70 percent of the expe cted disbursements 
had been made, and the disbursement rate  was climbing. Some of the programmes 
had achieved spectacular results. For instan ce, in the Global Fund TB programmes in 
China, Ghana, Indonesia, Mongolia, Panama and Sri Lanka, performance targets were exceeded by 32%.
xxx 
 
EN 16   EN Developing countries have expresse d positive views on the Global Fund’s 
performance and have, in particular, unde rlined ownership ba sed on the national 
development of programmes and global representation at Board level; the flexibilities offered by Global Fund financi ng, especially with regard to recurrent 
costs, which are rarely permitted under the guidelines of most other aid agencies 
(with the exception of the EC ); and the openness and transp arency in transactions 
(e.g. the Global Fund’s activities are accessi ble on its website, including the results 
of negotiations of pharmaceutical product pricing). 
If sufficient resources are provided to meet  the increase in demand, then the current 
business model must be adapted to make the operations more effective and reduce 
transaction costs. Key suggestions to streamline Global Fund procedures include: 
• The Global Fund could adopt a differentiat ed approach based on a risk analysis, 
taking into account contextual considera tions and past performance of grant 
receivers. 
• The Global Fund could establish a public  and a private f unding channel in a 
country with an approved proposal. The pr incipal recipient fo r the public channel 
would be likely to be the Ministry of Hea lth or the Ministry of Finance, while the 
private channel could be NGOs and ta ke on a country-appropriate form. 
• Existing mechanisms such as the country -specific accreditation scheme (planned 
by the Health Metrics Network) for mon itoring and evaluation systems could also 
be used as a standard for assessments, rather than using a parallel Global Fund 
assessment system. 
• The Global Fund Secretariat could play a mo re active role in identifying needs for 
technical assistance,  and garner support from donor agencies and other partners 
present in the country to improve the provision of such assistance. 
Any changes in the Global Fund business mode l must be based on the ability to serve 
the Global Fund recipients, both those who w ill directly receive and use funding and 
the people and communities living with, affect ed by and at risk from HIV/AIDS, TB 
and malaria. The performance of the Gl obal Fund programmes is measured by their 
ability to reach the poorest and most vulnerable. 
 
EN 17  
 EN Annex 3: New EC financial instruments (a s proposed by the EC, September 2004) 
Table 4 should be used for initial reflec tion on the potential us e of EC financial instruments for external action to confront the three diseases. Specific 
proposals will be presented in  a Programme for Action. 
Table 4: Overview of the proposed new EC fi nancial instruments and their potential to be used in confronting HIV/AIDS, malaria and TB 
Instruments 2007-13 (total 
amounts) Beneficiary countries What policy mix in regard to 
confronting three diseases? Channels of cooperation/financing 
Development Cooperation and 
Economic Cooperation Instrument (DCECI) 
(€41 088 million) All non-Member States (incl. 
their overseas territories) not covered by IPA and ENPI Long-term development 
assistance. Focus on Treaty objectives (mainly Art. 177), 
international engagements of the 
EC incl. MDG Coherence of policies; coordination with MS; coordination 
with international donors; sectoral and budget support; respect for HR and fundamenta l freedoms. Geographical as 
well as thematic and horizont al multi-annual programming 
and subsequent annual action programmes. 
European Neighbourhood and Partnership Instrument (ENPI) 
(€13 856 million) Algeria, Armenia, Azerbaijan, 
Belarus, Egypt, Georgia, Israel, 
Jordan, Lebanon, Libya, 
Moldova, Morocco, Palestinian Auth., Russian Federation, Syria, 
Tunisia, Ukraine Institution building, political 
cooperation “Supporting policies 
to fight poverty and promote 
social development, health, education and training, 
employment and social 
protection”. CSPs give margin for inclusion of disease-related financing. 
Thematic programmes “to address in a visible and 
recognisable way global challenges of particular importance” 
for all partner countries. MS can be associated for joint 
projects. 
Instrument for Pre-Accession Assistance (IPA) 
(€13 271 million) Croatia, Turkey, Western Balkans Institution building, human 
resources development, cross-
border cooperation, No specific 
provision for health systems. Financing through instruments similar to the structural funds 
and PHARE/ISPA/SAPARD structure. Association 
agreements. 
Stability instrument 
(€4 258 million) All third countries (except 
overseas territories of EU) Rapid response to crises; most 
activities DAC eligible; “major unexpected threats to public 
health” Complementary to the other instruments. 
 
EN 18   EN  
                                                 
Annex 4: References 
i Accelerated action targeted at ma jor communicable diseases within  the context of poverty reduction  
COM(2000) 585  
ii Programme for Action: Accelerated action on HIV/AIDS, malaria and tuberculosis in 
the context of poverty reduction  COM(2001) 96. Update on the EC Programme for Action: 
Accelerated action on HIV/AIDS, malaria and t uberculosis in the context of poverty 
reduction. Outstanding policy i ssues and future challenges  COM(2003) 93 
iii Second Progress report on the EC Program me for Action: Accelerated action on 
HIV/AIDS, malaria and tube rculosis in the context of poverty reduction (2004) 
iv http://europa.eu.int/comm/development/ body/theme/human_social/pol_health3_en.htm  
v “Coordinated and integrated approach to  combat HIV/AIDS within the European 
Union and its neighbourhood” This document outlin es the regional epidemic, synthesises best 
practice in prevention, reducing the impact of  the epidemic, and resources mobilisation and 
building partnerships. 
vi UNAIDS, Report on the Global AIDS Epidemic , 2004 
vii Estimated availability (2002): WHO, Consultation on Increasing Investments in Health 
Outcomes for the Poor , October 2003. Figure for HIV/AIDS from UNAIDS, Report on 
the Global AIDS Epidemic , 2004 
http://www.who.int/macrohealth/ev ents/health_for_poor/ en/1michaud.pdf  
Estimated resource gap (2003): The Global Fund, Annual Report 2003  
viii Regulation (EC) No 806/2004 of the Europe an Parliament and of the Council of 21 
April 2004 on promoting gender equality in development cooperation 
ix EC’s Development Policy, Statement by the Council and the Commission, 10 
November 2000 
x A collective EU average of 0.39% of GNI to ODA by 2006, and at least 0.33% of GNI 
for each individual EU Member State to ODA by 2006 
xi Translating the Monterrey Consensus into pr actice: the contribution by the European 
Union  COM(2004)150 
xii
 http://www.unaids.org/en/about+unaids/what +is+unaids/unaids+at+country+level/the
+three+ones.asp  
xiii The EC ensures its presence throughout the world through its 128 delegations and 
offices. 
 
EN 19   EN                                                                                                                                                          
xiv OECD, DAC, Development Coopera tion in Difficult Partnerships, 
http://www.oecd.org/dataoecd/26/53/21682588.pdf  
xv World Bank, HIV/AIDS Treatment and Prevention in India , 2004 
xvi http://www.who.int/healthmetrics/about/en/  
xvii The current annual ODA to health is approximately €6. 
xviii Richard Feachem, Executive Director of th e Global Fund Secretariat, at the 8th Board 
Meeting of the Global Fund, June 2004  
xix MSF, Untangling the web of price reductions , 2004 http://www.accessmed-
msf.org/documents/untanglingtheweb6.pdf  
xx TRIPs stands for the Agreement on Trade- Related Aspects of In tellectual Property 
Rights. The August 2003 Decision refers to the World Trade Organisation ‘Decision on 
the Implementation of Paragraph 6 of th e Declaration on the TRIPs Agreement and 
Public Health’ 
xxi Coplan, Mitchnik & Rosenburg, ‘Regulatory Challenges in Microbicide Development’ 
in Science , Vol. 304, 25 June 2004 http://www.ipm-
microbicides.org/pdfs/Reg_Chal_Dev.pdf  
MSF, Running out of Breath? TB Care in the 21st Century , 2004 
http://www.doctorswithoutborders.org/ publications/reports /2004/tbreport_2004.pdf  
xxii Regulation (EC) No 726/2004 (31 March 2004) , Article 58, OJ L 136, 30.4.2004, p.1 
xxiii In the US, the Food and Drug Administratio n has recently implemented a fast-track 
approval process allowing originator manufacturers to submit FDCs. Originator manufacturers have been pressu red into action to produce FDCs. 
xxiv Although more than 30 HIV/AIDS vaccine candidates are currentl y being tested in 
clinical trials no breakthrough is expected  in the short term. (www.aidsvaccine04.org ) It is 
estimated that US$1.1 billion is needed a nnually to develop an  HIV/AIDS vaccine. 
xxv MSF, AIDS Treatment Experience, Rapi d Expansion Emerging Challenges , 2004 
xxvi Communication COM(2004) 626, 29 September 2004 
xxvii * Domestic, Private, Multilateral and Bilateral (source UNAIDS, 2004; UN General 
Assembly, 2004). ** Bilateral and Multi lateral (sources UNAI DS, 2004; OECD/DAC, 
2004) 
xxviii UNAIDS, Report on the Global AIDS Epidemic , 2004 
http://www.unaids.org/bangkok2004/GAR2004_pdf/Chapter6_finance_en.pdf  
xxix Richard Feachem, Executive Director of th e Global Fund Secretariat, at the 8th Board 
Meeting of the Global Fund, June 2004  
 
EN 20   EN                                                                                                                                                          
xxx The Global Fund to Fight AIDS , Tuberculosis and Malaria, A Force for Change. The 
Global Fund at 30 Months , June 2004