Communication from the Commission to the Council and the European Parliament - A Coherent European Policy Framework for External Action to Confront HIV/AIDS, Malaria and Tuberculosis {SEC (2004) 1326 }
Date: 2004-10-26
Institutions: European Commission
Subjects: AIDS, aid policy, health aid, infectious disease

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.10.2004 
COM(2004) 726 final 

.   

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND 
THE EUROPEAN PARLIAMENT 

A Coherent European Policy Framework for External Action to Confront HIV/AIDS, 
Malaria and Tuberculosis 

{SEC (2004) 1326 } 

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TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

3. 

3.1. 

3.2. 

4. 

4.1. 

4.2. 

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

Challenges .................................................................................................................... 3 

Epidemiological, geographical and demographical challenges ................................... 3 

Challenges to maintain a comprehensive policy mix of prevention, treatment 
and care ........................................................................................................................ 4 

Challenges in financing................................................................................................ 4 

Challenges in governance at country and global levels ............................................... 5 

EU vision...................................................................................................................... 6 

Vision for 2015 ............................................................................................................ 6 

Principles...................................................................................................................... 7 

EC added value and EC actions ................................................................................... 7 

EC added value ............................................................................................................ 7 

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 ..................................................................................................... 10 

4.3.3.  New tools and interventions....................................................................................... 11 

4.3.4.  Strengthened partnerships and a strong European voice............................................ 11 

5. 

6. 

EC tools...................................................................................................................... 12 

Conclusion.................................................................................................................. 12 

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1. 

INTRODUCTION 

In  2000,  Europe  made  a  commitment  to  achieving  the  Millennium  Development 
Goals (MDGs) and the European Union (EU) adopted its new development policy, 
based  on  poverty  reduction.  At  the  same  time,  the  European  Commission  (EC) 
developed  a  comprehensive  frameworki  to  accelerate  action  targeted  at  the  three 
major poverty diseases – HIV/AIDS, malaria 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 areas of development, trade 
and research. 

The EU needs to accelerate action and address 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 arena and rise to new challenges. There is 
a growing  awareness of the effect that HIV/AIDS can have  on human security  and 
human rights. The changing nature and rapid spread of HIV/AIDS and TB globally 
also  warrant  consideration.  Sustaining  policy  coherence  regarding  HIV/AIDS, 
malaria and TB remains a major challenge. 

This  Communication  provides  the  policy  framework  for  all  EC  external  action  on 
confronting  the  three  diseases.  The  Communication  has  been  prepared  following 
stakeholder  consultations  with  third  countries,  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  concrete  actions  for  the  next  eighteen 
months.v  These  actions  and  recommendations  to  partners  were  endorsed  in  the 
“Vilnius Declaration” adopted by participants in the Ministerial Conference “Europe 
and HIV/AIDS: New Challenges, New Opportunities” (Vilnius, 17 September 2004). 

2. 

CHALLENGES 

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 continues to rise. More than 6 million people 
in the world die each year from the three diseases, and the effectiveness of treatment 
is  threatened  by  the  emergence  of  multi-drug  resistant  malaria  and  TB.  HIV/AIDS 
and  TB  are  spreading  rapidly,  including  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  India)  is  increasing.  Malaria  poses  a  large 
burden particularly on African countries. Sub-Saharan Africa continues 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 

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Particularly with regard to developing countries, poverty reduction remains the main 
framework  in  which  to  confront  the  three  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  wider  Cairo  agenda  (including  HIV/AIDS, 
and  gender-based  violence)  is  becoming  increasingly  obvious.  This  demands 
consideration of human security and human rights. The spread of the three diseases 
among  refugees  and  people  living  in  conflict  situations  remains  a  challenge.  The 
HIV/AIDS  pandemic  continues  to  affect  women  disproportionately  in  terms  of 
infection  rate,  impact  and  lack  of  access  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  comprehensive  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  comprehensive  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  promoted  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 prevention 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 increased globally, primarily because of an 
increase from domestic budgets and the private contribution (see Annex 1, Table 2). 
There are scant global funding figures available on malaria and TB. 

Despite  the  increase,  a  considerable  gap  remains  in  terms  of  external  resources  to 
confront the three diseases (see Table 1). The international community will need to 
secure  appropriate  funding  to  match  demand.UN  estimates  of  the  resources  needed 
by region to confront HIV/AIDS over the next few years are given in Annex 1, Table 
3. However, this Communication does not have financial implications for the EC. 

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Table 1 – Estimated annual ODA and external resource gapvii 

In US$ billion 

4,5 
4 
3,5 
3 
2,5 
2 
1,5 
1 
0,5 
0 

Resource gap in 
external financing 
Resource availability of 
ODA

HIV/AIDS

Tuberculosis

Malaria

2.4. 

Challenges in governance at country and global levels 

Reaching  the  affected  countries,  the  poorest  people,  and  the  disenfranchised  of 
all  societies  remains  a  challenge.  Populations  already  facing  barriers  to  care  (in 
particular  women  and  the  poor)  have  become  increasingly  marginalised.  Many 
behaviours  associated  with  increased  risk  of  HIV/AIDS  (e.g.  men  having  sex  with 
men, injecting drug use, commercial sex work) 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 planning, policy and implementation is crucial to 
address needs. 

Strong  leadership  within  countries  is  essential,  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  institutional  or  national  boundaries  is 
another challenge. Confronting them requires strong cooperation between all partners 
in society. Some countries have managed to establish cross-sectoral cooperation with 
concrete  results.  The  Country  Coordinating  Mechanisms  (CCMs)  set  up  to  access 
Global  Fund  support  can  play  a  strong  role  in  catalysing  cooperation  between 
implementation. 
different  partners,  promoting  harmonisation  and  facilitating 
Confronting  the  three  diseases  often  requires  a  cross-border  response,  which  is 
difficult where regional institutions 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 initiatives (e.g. the European 
and  Developing  Countries  Clinical  Trials  Partnership  (EDCTP)  and  the  Global 
Fund), remains a challenge. 

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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,  negotiation  capacity  or  voting  rights  to  design  and  implement 
global  rules  to  their  advantage  (e.g.  regarding  research  priorities  and  regulatory 
frameworks).  The  increase  in  the  number  and  diversity  of  global  initiatives  and 
players  in  the  HIV/AIDS,  malaria  and  TB  arena  has  further  altered  the  global 
institutional  structure,  and  poses  opportunities  and  challenges 
terms  of 
harmonisation  and  coherence.  The  recent  enlargement  of  the  EU  has  brought  the 
impact of HIV/AIDS and TB in ENP partner countries in Eastern Europe higher on 
the European agenda. 

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3. 

EU VISION 

3.1. 

Vision for 2015 

The EC will continue to respond 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 international commitments and share a long-term 
vision  towards  confronting  the  three  diseases  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 endorsed the Programme of Action adopted in Cairo in 1994 
at the International Conference on Population and Development (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 Action 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 mainstreaming as a main strategy.viii All EU 
Member  States  have  ratified  the  UN  Convention  on  the  Rights  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 confronting the three diseases. 

Increasing  resources  and  coordinating  efforts  are  also  part  of  the  EU  vision.  The 
0.7%  of  gross  national  income  (GNI)  remains  a  recognised  target  for  EU  Member 
States’ allocations to ODA. The EU is well 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 and the EU Member States are bound by the 
Treaty to operate in coordination and complementarity in the field of development 
cooperation, a commitment reaffirmed at the High-Level Forum on Harmonisation in 
Rome  (2003).  The  principles  of  harmonisation  across  strategy,  agency  and 
monitoring plan are also reflected in the 3 Ones approach to HIV/AIDS.xii 

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3.2. 

Principles 

Several  shared  principles  guide  Europe’s  cooperation  with  third  countries.  The  EU 
closely adheres to the overall development 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  the  key  decision-makers  responsible  for 
formulating  their  strategic  priorities  and  national  frameworks.  Governments  are 
accountable  to  their  electorates  for  their  choices  and  for  implementation.  Good 
governance, with the ability to ensure transparent 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.  Working  with  third  countries  also  requires  the 
scaling-up  of  actions,  and  increasing  sustainable  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 consultations, the EC has several attributes of 
comparative advantage for action on the three diseases. The majority of EC financial 
support instruments are, and will 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  across  policy  areas  of  development, 
humanitarian aid, trade, and research towards coherent external action. Activities in 
different policy areas can reinforce each other 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 and 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  countries  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 commodity purchasing – a major component of 
health expenditure. 

A  final  aspect  of  added  value  is  the  flexibility  in  the  current  EC  thematic  budget 
lines,  which  allow  for  the  financing  of  innovative  actions  both  at  country  and  at 
global  level.  This  has  allowed  for  support  to  the  Global  Fund,  to  the  International 
AIDS  Vaccine  Initiative  (IAVI),  to  the  International  Partnership  for  Microbicides 
(IPM), and to the EDCTP sites for clinical trials in disease-endemic countries. Such 
flexibility should be retained in the new financial instruments for EC external action 
(2007-2013). 

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4.2. 

EC action at country level 

The geographic spread of the diseases requires a focus beyond developing countries. 
In  particular,  multi-drug  resistant  TB  and  HIV/AIDS  are  spreading  fast  in  ENP 
partner countries. The EC is able to provide a policy mix of country 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  related  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,  political  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  Reduction  Strategy  Papers.  This  will 
strengthen  social  services,  including  health  and  education.  Improving  human 
resource  capacity  includes  accelerated  action  on  staff  training,  career  development, 
appropriate remuneration and retention of staff, and responsive management. These 
actions will address some of the key motivational problems faced by health staff, and 
might therefore dent the drastic brain drain of staff from rural to urban, from public 
to  private,  and  from  developing  to  developed  countries.  The  EC  recommends 
countries and donors to agree on a financing model where disease-specific initiatives 
contribute  a  defined  proportion  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  countries;  or  for  organisations  employing 
national  staff  to  train  counterpart  staff  within  the  government  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  diseases  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 with 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  prevention,  treatment  and  care,  is  necessary.  An  appropriate 
mix depends on the nature of the disease, capacities and resources available, and best 
practice.  For  HIV/AIDS,  evidence  shows  that  condom  use  and  open  discussion  of 
sexual activity – rather than abstinence – are the most effective tools for preventing 
sexual transmission. A recent study on India illustratedxv 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. 

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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 address 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 contraceptives – needs to be an integral part 
of the analysis of conflicts, their causes, effects and resolution. 

The  EC  will  support  local  production  capacity,  e.g.  for  raw  materials  and 
formulations  of  artemisinin-based  combination  therapies  (ACT)  and  other  new 
antimalarials,  insecticide-treated  bednets,  condoms,  and  generic  production  of 
essential drugs – including fixed-dose combinations (FDCs) for TB and HIV/AIDS. 
Local production can promote competition and make pharmaceutical products more 
affordable.  It  is  important  to  encourage  technology  transfer  to  ensure  that  locally 
produced  pharmaceutical  products  meet  internationally  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  healthcare  services  should  be  explored,  with  the 
active involvement of partner countries. The EDCTP should play an integrating role 
by  contributing  to  both  national  and  regional  human  resource  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  three  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  Macroeconomics  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 €120 billion. Private investment in third 
countries and official development assistance (ODA) are needed.xvii The EU should 
continue  to  adhere  to  commitments  made  in  Monterrey  on  raising  ODA.  The 
capacity  of  countries  to  absorb  increased  resources  should  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  confronting  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 

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The need for a substantial EU contribution, 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 increased 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  reduction  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  producers  and  public  tendering  based  on  fair  and  transparent 
procurement rules to reduce prices. 

The EC will also encourage countries to publish in a transparent 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 purchasing 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 formal amendments of the TRIPs Agreement, 
through  bilateral  negotiations,  or  through  national  legislation.  The  EC  encourages 
developing  countries  to  make  use  of  TRIPs  flexibility  and  exemptions,  including 
compulsory  licensing  while  stressing  the  importance  of  an  adequate  intellectual 
property regime. 

The  EC  will  provide  technical  assistance  to  improve  countries’  capacities  in 
pharmaceutical policies, including through continued and strengthened partnership 
with WHO on prequalification. The EC will continue to emphasise the need for safe 
pharmaceutical products. The EC Enforcement Strategy Paper (June 2004) contains 
guidelines  for  EC  action  on  the  enforcement  of  intellectual  property  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 challenges for new vaccines, microbicides and diagnostics 
need  to  be  addressed.xxi  The  European  Medicines  Agency  (EMEA)  and  national 
regulatory  authorities  in  the  EU,  could  support  –  in  coordination  with  WHO  – 
capacity  building  for  regulatory  bodies  through  partnerships,  scientific/technical 
assistance or financial support. This should focus on establishing regional centres of 
regulatory expertise in, for example, Brazil, South Africa and Thailand. Regulatory 

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procedures should not be used as trade obstacles, which could make pharmaceutical 
products more expensive. 

Assistance  provided  by  the  EMEA  will  build  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  generic  manufacturers,  should  enable  the 
Community to provide scientific support to developing countries, thereby facilitating 
rapid access to medicinal products which 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  cost-efficient  tool  to  confront  the  three 
diseases,  but  a  comprehensive  research  approach  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.  Special  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 products entering clinical trials. The EC will encourage 
Member  States  and  industry  to  invest  in  and  make  use  of  the  EDCTP  programme. 
The EDCTP will ensure coherence and synergy between clinical trials carried out by 
itself and by other organisations. 

The  results  of  extensive  monitoring  in  the  relevant  social  and  economic  context 
should be used to improve the impact of existing interventions and diagnostic tools. 
Epidemiology  and  applied  research  will  therefore  be  an  integrated  part  of  the 
research agenda. 

Following stakeholder consultations, the EC will establish incentives to harness the 
capacity  of  private  industry,  including  small  and  medium-sized  biotech  enterprises, 
in  the  development  of  new  tools  targeting  the  three  diseases.  Incentives  could 
include:  the  extension  of  patent  rights  and/or  market  exclusivity,  including  through 
the  relationship  which  might  be  established  between  different  products,  simplified 
and  faster  regulatory  procedures,  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 dialogue and funding to multilateral 
UN  organisations:  the  strategic  partnership  with  WHO  (on  pharmaceutical  policy, 
regulatory issues, and health monitoring), and the strong partnership with UNAIDS 

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(regarding the 3 Ones) and UNFPA (for the Cairo agenda). This should be seen as 
part  of  an  EC  response  to  the  challenges  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 support a needs-driven global research agenda by supporting 
the  EDCTP  and  by  partnering  with  other  international  research  initiatives,  such  as 
IAVI, IPM, GAVI, and the Global HIV Vaccine Enterprise (endorsed by G8). 

The  EC  will  continue  to  present  a  strong  voice  advocating  common  European 
values  at  fora  following  Cairo  and  Doha,  with  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  between  EC  services,  including  delegations, 
responsible  for  various  parts  of  the  programming  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 challenges, including the three diseases. The 
new financial instruments benefit the poorest countries, while also supporting the EU 
neighbourhood. Six instruments are proposed, three supporting EU external policies 
(pre-accession, neighbourhood and development), and three thematic instruments to 
respond to political, humanitarian and financial 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 established a momentum for action between 
different  stakeholders.  The  EC  will  continue  to  amplify  this  momentum,  and 
establish  a  Stakeholder  Forum  to  ensure  continued  consultation,  including  people 
living with HIV/AIDS, malaria or TB, on how to confront the three diseases and on 
instruments and financing needed. 

6. 

CONCLUSION 

The  Policy  framework  (2000)  and  the  Programme  for  Action  adopted  in  2001 
achieved  significant  results  in  confronting  the  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 the 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. 

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Based  on  this  comprehensive  policy  framework,  new  strategies  and  action 
programmes  will  be  developed.  These  will  refer  to  the  use  of  specific  instruments 
and  resources,  and  will  propose  further  coordination  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 Cairo 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. 

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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*

Global resources*
ODA**

ODA**

5000

4500

4000

3500

3000

2500

2000

1500

1000

500

0

n
o

i
l
l
i

M
$
S
U

1996

1997

1998

1999

2000

Years

2001

2002

2003

Table  3:  Projected  Annual  HIV/AIDS  financing  needs  (in  US$  million)  by 
region (2004-2007)xxviii 

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Annex 2: The Global Fund to Fight AIDS, 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  departs  from  traditional  forms  of  multilateral 
governance  because  non-state  actors  share  decision-making  powers  and  financing 
responsibilities  with  national  governments.  This  reflects  the  political  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 purchasing 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  disbursements  of  US$3  billion  from  2008  onwards. 
This forecast predicts a considerable increase 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  contributions  to  the  Global  Fund  would  have  to 
triple from its current US$1 billion to respond to the increase in resource demands. 
The 2005 high-level replenishment conference of the Global Fund is an opportunity 
for  all  donors  to  increase  their  contributions  to  the  Fund.  As  tens  of  thousands  of 
people  begin  receiving  anti-retroviral  treatment  financed  by  the  Global  Fund,  the 
issue  of  sustainable  and  predictable  funding  is  even  more  important.  Countries 
should  gradually  move  towards  self-sustaining  financial  systems.  However,  faced 
with severe resource constraints in the poorest countries, the global community will 
need to continue its support 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  effectively  use  large 
sums  of  money,  especially  with  the  significant  brain  drain  in  developing  countries, 
which depletes human resources, particularly in the health services most needed. It 
has  also  been  discussed  whether  the  disease-specific  approach  committing  global 
finance  primarily  to  the  three  diseases,  instead  of  health  services,  is,  in  general, 
beneficial.  The  Global  Fund  programmes  have  so  far  been  successful  in  delivering 
the  demand  at  country  level.  Some  countries  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 expected disbursements 
had  been  made,  and  the  disbursement  rate  was  climbing.  Some  of  the  programmes 
had achieved spectacular results. For instance, in the Global Fund TB programmes in 
China,  Ghana,  Indonesia,  Mongolia,  Panama  and  Sri  Lanka,  performance  targets 
were exceeded by 32%.xxx 

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Developing  countries  have  expressed  positive  views  on  the  Global  Fund’s 
performance  and  have,  in  particular,  underlined  ownership  based  on  the  national 
development  of  programmes  and  global  representation  at  Board  level;  the 
flexibilities  offered  by  Global  Fund  financing,  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  transparency  in  transactions 
(e.g. the Global Fund’s activities are accessible 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 differentiated approach based on a risk analysis, 
taking  into  account  contextual  considerations  and  past  performance  of  grant 
receivers. 

•  The  Global  Fund  could  establish  a  public  and  a  private  funding  channel  in  a 
country with an approved proposal. The principal recipient for the public channel 
would be likely to be the Ministry of Health or the Ministry of Finance, while the 
private channel could be NGOs and take on a country-appropriate form. 

•  Existing mechanisms such as the country-specific accreditation scheme (planned 
by the Health Metrics Network) for monitoring 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 more 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 model must be based on the ability to serve 
the Global Fund recipients, both those who will directly receive and use funding and 
the people and communities living with, affected by and at risk from HIV/AIDS, TB 
and malaria. The performance of the Global Fund programmes is measured by their 
ability to reach the poorest and most vulnerable. 

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Annex 3: New EC financial instruments (as proposed by the EC, September 2004) 

Table 4 should be used for initial reflection on the potential use 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 financial instruments and their potential to be used in confronting HIV/AIDS, malaria and TB 

Instruments 
amounts) 

2007-13 

(total 

Beneficiary countries 

What  policy  mix  in  regard  to 
confronting three diseases? 

Channels of cooperation/financing 

Development  Cooperation  and 
Economic 
Cooperation 
Instrument (DCECI) 

All  non-Member  States  (incl. 
their  overseas 
territories)  not 
covered by IPA and ENPI 

(€41 088 million) 

European  Neighbourhood  and 
Partnership Instrument (ENPI) 

(€13 856 million) 

Algeria,  Armenia,  Azerbaijan, 
Belarus,  Egypt,  Georgia,  Israel, 
Jordan, 
Libya, 
Lebanon, 
Moldova,  Morocco,  Palestinian 
Auth.,  Russian  Federation,  Syria, 
Tunisia, Ukraine 

Instrument 
Assistance (IPA) 

for  Pre-Accession 

Croatia, Turkey, Western Balkans 

third 

All 
overseas territories of EU) 

countries 

(except 

(€13 271 million) 

Stability instrument 

(€4 258 million) 

EN 

Long-term 
development 
assistance.  Focus  on  Treaty 
(mainly  Art.  177), 
objectives 
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  fundamental  freedoms.  Geographical  as 
well  as  thematic  and  horizontal  multi-annual  programming 
and subsequent annual action programmes. 

political 
building, 
Institution 
cooperation  “Supporting  policies 
to  fight  poverty  and  promote 
health, 
development, 
social 
training, 
education 
and 
social 
employment 
protection”. 

and 

building, 

Institution 
human 
resources  development,  cross-
border  cooperation,  No  specific 
provision for health systems. 

Rapid  response  to  crises;  most 
activities  DAC  eligible;  “major 
unexpected 
to  public 
threats 
health” 

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. 

Financing through instruments similar to the structural funds 
structure.  Association 
and 
agreements. 

PHARE/ISPA/SAPARD 

Complementary to the other instruments. 

17 
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Annex 4: References 

Accelerated  action  targeted  at  major  communicable  diseases  within  the  context  of  poverty  reduction 

i 
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  tuberculosis  in  the  context  of  poverty 
reduction. Outstanding policy issues and future challenges COM(2003) 93 

Second  Progress  report  on  the  EC  Programme  for  Action:  Accelerated  action  on 

iii 
HIV/AIDS, malaria and tuberculosis 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 outlines the regional epidemic, synthesises best 
practice  in  prevention,  reducing  the  impact  of  the  epidemic,  and  resources  mobilisation  and 
building partnerships. 

vi 

vii 

viii 

ix 

x 

xi 

xii

xiii 

UNAIDS, Report on the Global AIDS Epidemic, 2004 

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/events/health_for_poor/en/1michaud.pdf 
Estimated resource gap (2003): The Global Fund, Annual Report 2003 

Regulation  (EC)  No  806/2004  of  the  European  Parliament  and  of  the  Council  of  21 
April 2004 on promoting gender equality in development cooperation 

EC’s  Development  Policy,  Statement  by  the  Council  and  the  Commission,  10 
November 2000 

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 

Translating the Monterrey Consensus into practice: the contribution by the European 
Union COM(2004)150 

  http://www.unaids.org/en/about+unaids/what+is+unaids/unaids+at+country+level/the
+three+ones.asp 

The  EC  ensures  its  presence  throughout  the  world  through  its  128  delegations  and 
offices. 

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xiv 

OECD,  DAC,  Development 
Cooperation 
http://www.oecd.org/dataoecd/26/53/21682588.pdf 

in  Difficult 

Partnerships, 

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 the 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 

xxi 

TRIPs  stands  for  the  Agreement  on  Trade-Related  Aspects  of  Intellectual  Property 
Rights. The August 2003 Decision refers to the World Trade Organisation ‘Decision on 
the  Implementation  of  Paragraph  6  of  the  Declaration  on  the  TRIPs  Agreement  and 
Public Health’ 

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  Administration  has  recently  implemented  a  fast-track 
approval  process  allowing  originator  manufacturers  to  submit  FDCs.  Originator 
manufacturers have been pressured into action to produce FDCs. 

xxiv  Although  more  than  30  HIV/AIDS  vaccine  candidates  are  currently  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 annually to develop an HIV/AIDS vaccine. 

xxv  MSF, AIDS Treatment Experience, Rapid 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 Multilateral (sources UNAIDS, 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 the Global Fund Secretariat, at the 8th Board 

Meeting of the Global Fund, June 2004 

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xxx 

The Global Fund to Fight AIDS, Tuberculosis and Malaria, A Force for Change. The 
Global Fund at 30 Months, June 2004 

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