Communication from the Commission to the Council and the European Parliament - A European Programme for Action to Confront HIV/AIDS, Malaria and Tuberculosis through External Action (2007-2011)
Date: 2005-04-27
Institutions: European Commission
Subjects: AIDS, action programme, aid policy, developing countries, health aid, infectious disease

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 27.04.2005 
COM(2005) 179 final 

.  

COMMUNICATION FROM THE COMMISSION 
TO THE COUNCIL AND THE EUROPEAN PARLIAMENT 

A European Programme for Action to Confront HIV/AIDS, Malaria and Tuberculosis 
through External Action (2007-2011) 

EN 

   EN 

 
 
 
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE 
EUROPEAN PARLIAMENT 

A European Programme for Action to Confront HIV/AIDS, Malaria and Tuberculosis 
through External Action (2007-2011) 

1. 

THE POLICY CONTEXT AND SCOPE OF THE PROGRAMME FOR ACTION 

In October 2004, the European Commission (EC) adopted a Communication entitled 
“A  Coherent  European  Policy  Framework  for  External  Action  to  Confront 
HIV/AIDS,  Malaria  and  Tuberculosis  (TB)”  –  COM(2004)  726  final1  This  was 
prepared  based  on  a  second  progress  report  on  the  “EC  Programme  for  Action: 
Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty 
reduction” that highlighted key results and areas where the EC needs to reinforce or 
take further action.2 

The  Council  welcomed  the  policy  framework,  urged  the  EC  and  the  EU  Member 
States (EU MSs) to enhance their cooperation and coordination to confront the three 
diseases and requested the Commission to present a Programme for Action (PfA).3 

This  PfA  responds  to  the  Council  Conclusions  on  harmonisation,4  by  proposing 
collective EU (EC and EU MSs) action to support country-lead programmes to 
confront the three diseases5 and action at global level in selected areas where the EU 
can add value. 

The  PfA  will  cover  developing  and  middle-income  countries.  It  is  based  on  the 
general  principle  of  benefiting  from  best  practices  and  experience  in  the  external 
actions and from the relevant Community policies. Later this year, the Commission 
will adopt a Communication on how to confront HIV/AIDS within the EU and in the 
neighbouring  countries.  Country  strategy  programmes  (CSPs)  and  European 
Neighbourhood  Policy  Action  Plans  will  define  an  appropriate  strategy  and  set  of 
actions.  

The  response  to  HIV/AIDS,  malaria  and  TB  is  still  underfunded.  Additional 
funds  will  mainly  have  to  come  from  external  sources  –  public  and  private.  The 
projected  annual  external  resource  gap  will  continue  to  grow  and  is  estimated  to 
reach US$14.9 billion by 2007 – US$11.5 billion for HIV/AIDS, US$2.6 billion for 
malaria, and US$0.8 billion for TB.6 These figures only partly include resources for 
strengthening  of  the  health  system  in  partner  countries,  which  is  a  prerequisite  for 

1 
2 
3 
4 
5 

6 

COM(2004) 726 final 
SEC(2004) 1326 
Council Conclusions of 23 November 2004 (doc. 15158/04) 
Council Conclusions of 24 November 2004 (doc. 15159/04) 
References to common action in countries are made under action points 1, 3, 5, 6, 9, 10, 13, 15, 16 and 
18 and to common action at global level under action points 19, 23, 26, 27, 28, 29 and 30. 
The Global Fund, Addressing HIV/AIDS, Malaria and Tuberculosis: The Resource Needs of the Global 
Fund 2005-2007, 2005 

EN 

2 

   EN 

 
                                                 
progress, and the need for further investment in the research and development of new 
tools and interventions. 

A major objective of this PfA is to increase efforts to scale up interventions that 
have  shown  results.  The  EU  should  aim  for  a  contribution  that  helps  to  fill  the 
financing  gap  for  the  three  diseases  and  meet  the  Millennium  Development  Goal 
(MDG)  6  and  that  reflects  Europe’s  weight  and  importance  as  an  international 
partner in development. 

2. 

EU ACTIONS AT COUNTRY LEVEL 

Country  leadership  is  the  key  to  confront  these  diseases  and  their  consequences 
through broad-based strategies. The participation of civil society – including people 
affected  by  the  diseases  –  and  partnership  with  public  and  private  stakeholders, 
donors  and  international  agencies  are  essential  for  scaling  up  efforts  that  lead  to 
success. (See Annex 1.) 

2.1. 

Political  and  policy  dialogue  to  support  country-led  strategies  to  confront  the 
three diseases 

(1) 

(2) 

(3) 

The  EU  will  reinforce  its  political  dialogue  with  countries  on  key  issues 
relating to leadership and governance. The dialogue will address the need for 
a  comprehensive  strategy  with  an  appropriate  balance  between  prevention, 
treatment and care, depending on the situation in each country. Other subjects 
for  dialogue  include  children’s  rights,  women’s  rights,  and  sexual  and 
reproductive health and rights. The dialogue should also address the needs of 
orphans and vulnerable children. The “Framework”  adopted in July 2004 
should  be  used  by  EC  staff  for  this  purpose.7  The  dialogue  should  address 
other vulnerable groups, such as injecting drug users, prisoners, elderly 
people,  people  with  disabilities,  refugees  and  internally  displaced 
populations,  as  well  as  issues  around  stigma  and  discrimination.  The 
application of the Greater Involvement of People Living with AIDS (GIPA) 
principle needs to be extended to the three diseases.8 

To help implement policy, the EC will prepare a toolkit for Delegations and 
services  which  will  include  guidelines  for  policy  dialogue,  programming 
guidelines  offering  advice  concerning  indicators  and  monitoring  of  country 
efforts,  and  reference  documents.  It  will  be  reviewed  and  updated 
periodically. Awareness raising and training will be provided for EC staff. 

The EU will share expertise to ensure that the EU collectively has a critical 
mass  of  expertise  to  play  a  constructive  role  in  the  policy  and  technical 
dialogue,  including  in  PRSP  reviews,  sector  policy  dialogue  and  in  the 
Country Coordinating Mechanisms (CCMs) of the Global Fund. In countries 
where the EC does not have specific expertise, Delegations will work actively 
with  EU  MS  experts  and  other  partners,  including  UN  agencies.  Such 

7 

8 

The Framework for the Protection, Care and Support of Orphans and Vulnerable Children Living in a 
World with HIV and AIDS, July 2004 
For further information on the GIPA principle, see UNAIDS, 2004 Report on the Global AIDS Epidemic 

EN 

3 

   EN 

 
                                                 
arrangements  may  include  shared  programming,  monitoring  and  reporting, 
and will make optimum use of EU regional expertise. 

(4) 

EC Delegations will promote health and disease prevention amongst staff, 
particularly  for  HIV/AIDS,  building  on  the  ILO  Code  of  Practice  on 
HIV/AIDS, while also addressing relevant issues concerning TB and malaria. 
In  staff  training,  Delegations  will  be  encouraged  to  use  the  training  manual 
developed  by  ILO.9  Delegations  will  assist  and  support  staff  and  their 
families through adequate social protection schemes. 

2.2. 

Capacity building to confront the three diseases 

(5) 

(6) 

(7) 

The  EU  will  map  TA  resources  available  to  countries  with  a  view  to 
developing  a  plan  for  shared  TA,  governed  by  a  code  of  conduct  for 
collective action. Such assistance should be provided, e.g. by UN agencies, at 
the request of broad-based national or regional bodies such as the CCMs and 
sector coordination platforms. 

The EU will support the case for health being treated as an exceptional case 
in public sector reform programmes, increasing public spending to allocate a 
sufficient  share  of  public  expenditure  to  health  (e.g.  the  15%  Abuja 
commitment  for  African  countries),  and  will  maintain  its  dialogue  with  the 
Bretton  Woods  institutions  on  the  appropriate  fiscal  space  for  action  on  the 
three diseases. 

through 

The  EC  will  strengthen  national  programmes  to  build  clinical  research 
capacity  through  the  European  and  Developing  Countries  Clinical  Trials 
Partnership  (EDCTP).  General  support  for  life  science  research  will  be 
the  7th  Framework  Programme  for  Research  and 
provided 
Technological Development (FP7). The EC will also support synergy in the 
approach  to  health  research  (EDCTP)  and  health  care  activities  at  country 
level, in a selected number of partner countries. Synergies between capacity 
building  for  research  and  training  of  staff  for  health  care  should  be  fully 
explored.  The  EDCTP  should  play  an  integrating  role  by  contributing  to 
national  and  regional  human  resource  plans  for  clinical  research.  Further 
efforts are needed to support complementary health care activities, including 
improving 
trials  sites, 
local  or  regional  health  services  at  clinical 
reinforcement  of  human  resources,  building  of  new  infrastructures  such  as 
hospital  wards,  and  ensuring  access  to  medical  care  coverage  for  the 
population during clinical trials. 

(8) 

The  EC  will  provide  further  technical  support  to  improve  countries’ 
capacities to develop pharmaceutical policy, including through its strategic 
partnership with WHO. The EC will encourage WHO to identify key issues 
that pharmaceutical policy needs to address. 

(9) 

The  EU  will  support  countries 
in  developing  sound  and  efficient 
procurement  policies  and  practices  for  pharmaceutical  products  and 

9 

http://www.ilo.org/public/english/protection/trav/aids/code/codemain.htm 

EN 

4 

   EN 

 
                                                 
commodities, such as condoms, long-lasting insecticide-treated bed nets (LL-
ITNs) and anti-retrovirals. 

(10)  The  EU  will  strive  to  exploit  mutual  synergies  between  programmes  and 
measures to implement the Convention on the Rights of the Child, the Beijing 
agenda  on  gender  equality,  the  Cairo  agenda  on  sexual  and  reproductive 
health  and  rights  (SRHR),  and  UNGASS  and  other  UN  strategies  and 
programmes to confront HIV/AIDS, malaria and TB. 

(11) 

(12) 

In countries where the EC supports the education sector, the EC will pursue 
through  sector  and  policy  dialogue  the  inclusion  of  lifeskill  education  and 
safe schools for children, especially girls, to increase protection against rape, 
pregnancy  or  infection  with  HIV/AIDS  and  other  sexually  transmitted 
diseases (STDs). The EC will help to establish and support codes of conduct, 
training of school staff, and community protection mechanisms. 

its 

implementing  partners.  This  will 

In emergency situations and protracted crises, the EC Humanitarian Office 
(ECHO)  will  help  to  reduce  the  transmission  of  the  three  diseases,  and  the 
human distress and mortality they cause by mainstreaming basic HIV/AIDS 
preventive and palliative measures, both in its humanitarian programmes and 
via 
include  awareness-raising, 
information,  training  and  the  provision  of  prevention  tools  for  humanitarian 
workers.  Preventive  and  curative  measures  against  malaria  and  TB  already 
form  an  integral  part  of  the  humanitarian  response  supported  by  ECHO. 
Consultations  on  the  three  diseases  with  other  donors  and  EC  departments 
will  become  an  essential  part  of  the  Linking  Relief,  Rehabilitation  and 
Development (LRRD) process. 

(13)  To  help  national  initiatives  to  counter  rape,  violence  against  women,  child-
trafficking  and  the  spread  of  the  three  diseases  in  conflict-resolution, 
peacekeeping, and post-conflict situations, the EU will ensure that guidelines 
are  developed  and  awareness-raising, 
training  and 
prevention tools are provided for participants in such operations, in line 
with the UN Security Council Resolution of July 2000. 

information, 

(14)  The EC will analyse the impact of HIV/AIDS, malaria and TB on human 
security, e.g. in terms of access to basic services and stability at state-level, 
including  the  impact  of  these  diseases  on  governance  and  institutional 
performance.  The  results  will  feed  into  a  response  strategy  to  support 
countries affected. 

(15)  The  EU  will  support  countries  in collecting  and  monitoring  sex-  and  age-
disaggregated data on HIV/AIDS, malaria and TB. The EC will promote 
the use of indicators that can be meaningfully monitored on an annual basis 
through  national  health  information  systems,  including  through  behavioural 
surveillance  surveys.  In  line  with  the  “3  Ones”,  as  extended  to  malaria  and 
TB,  and  ongoing  efforts  at  donor  harmonisation  around  country-led 
strategies,  the  EU  will  work  with  countries,  WHO  (building  further  on  the 
Second Generation Surveillance Project, the Health Metrics Network, and the 
Roll-Back  Malaria  (RBM)  and  StopTB  partnerships),  UNAIDS  and  the 

EN 

5 

   EN 

 
Global Fund towards joint monitoring and performance assessment based on 
common indicators and shared reporting. 

2.3. 

Financial resources to confront the three diseases 

(16)  The  EU  will  continue  to  provide  resources  to  countries  for  confronting 
through  appropriate 

identified 

to  be 

HIV/AIDS,  malaria  and  TB, 
mechanisms. 

(17)  The EC will use partnerships and specific support to help finance highly cost-

effective interventions likely to yield rapid results, including: 

– 

– 

– 

Targeted  distribution  of  free  LL-ITNs  and  complementing  social 
marketing strategies which encourage local production capacity 

Targeted  distribution  of  free  contraceptives  linked  to  increased 
investment  in  health  promotion,  and  building  capacity  for  social 
marketing 

Provision of universal free access to voluntary counselling and testing 
(VCT) and antiretroviral drugs for HIV positive pregnant women. 

To achieve maximum impact, these should be delivered as part of a comprehensive 
package of interventions. 

(18)  The EU will work with countries to address concerns identified in the High 
Level Forum on Health MDGs and the review of the MDG focus of PRSPs. 
Despite strong MDG commitments, there has not yet been a significant shift 
in  resources  to  actions  capable  of  accelerating  progress  towards  the  health 
MDGs. The EC will support further work and action linking national policy 
commitments  to  the  MDGs  more  closely  with  financing  decisions  to 
reward  investment  in  evidence-based  strategies  for  accelerating  progress 
towards the MDGs, in particular MDG 6. 

3. 

EU ACTIONS AT GLOBAL LEVEL 

The EC will also undertake action at regional and global level to confront the three 
diseases, in partnership with EU MSs and other key players. Selected areas for action 
include  affordable  pharmaceutical  products,  regulatory  capacity,  human 
resources  in  the  health  sector,  and  research  and  development  of  new  tools  and 
interventions.  Global  efforts  to  promote  prevention,  treatment  and  care  remain  a 
cornerstone for confronting the three diseases. 

(19)  The EC will further develop its regional capacity through the use of regional 
health advisors, with specific focus on the three diseases. Tasks will include 
setting  up  a  network  of  EU  and  partner  expertise  to  exchange  experience, 
share  best  practice,  and  promote  regional  cooperation  in  the  fields  of 
regulatory and procurement capacity. 

EN 

6 

   EN 

 
3.1. 

Affordable and safe pharmaceutical products 

(20)  The  EC  will  monitor  the  implementation  and  the  results  of  the  EC 
Regulation  to  avoid  trade  diversion  into  the  EU  of  certain  key 
medicines.10 Through its dialogue with industry, the EC will encourage more 
companies  to  register  a  wide  selection  of  their  products  under  the  rules 
established through the Regulation. 

(21)  The EC will promote price transparency on pharmaceutical products and 
commodities  used  to  confront  the  three  diseases  by  asking  countries  to 
publish prices on products purchased by country programmes funded by the 
EC and by the Global Fund. Prices will be made available on the EC web site 
facilitating price comparisons, as a way of monitoring the impact of untying 
of aid. 

(22)  The EC will uphold the principles reflected in the 2001 Doha Declaration on 
TRIPs  and  public  health  and  in  the  August  2003  Decision  by  the  WTO 
General  Council.  The  EC  has  proposed  the  legislation  needed  by  European 
companies  to  issue  a  compulsory  licence  in  response  to  the  procedure 
described  in  the  Decision.11  The  EC  will  monitor  the  implementation  of  the 
August decision by exporting and importing parties, identify bottlenecks and 
provide  assistance  to  solve  them.  The  EC  will  actively  participate  in 
negotiations  with  the  aim  of  incorporating  the  Decision  into  the  TRIPs 
Agreement through a formal amendment. 

3.2. 

Regulatory capacity and prequalification 

(23)  The EC will cooperate with WHO, the European Medicines Agency (EMEA) 
and  interested  national  regulatory  bodies  of  EU  MSs  in  support  of  the 
development  of  the  capacity  of  national  and  regional  bodies  to  perform 
scientific  and  regulatory  tasks  with  respect  to  the  evaluation  and 
marketing authorisation of pharmaceutical products. This will include, in 
particular,  scientific  assistance  in  the  framework  of  the  so-called  ‘Article 
58’,12 plus specific guidelines on key products. 

(24)  The  EC  will  help  to  establish  regional  cooperation  networks  of  regulatory 
consultants  and  regional  schemes  of  mutual  recognition  for  marketing 
authorisation.  EC  support  will  include  a  feasibility  study,  in  cooperation 
with  the  African  Union  (AU)  on  the  setting-up  of  an  African  mutual 
recognition scheme for marketing authorisation. Cooperation should also help 
to  establish  regional  centres  of  regulatory  expertise  in  countries  with 
potential in this field e.g. Brazil, South Africa and Thailand. The EC is ready 
to join forces with WHO to help set up an international advisory committee 

10 
11 

12 

Regulation (EC) 953/2003. OJ L 135, 3.6.2003, p.5 
Proposal for a Regulation of the European Parliament and of the Council on compulsory licensing of 
patents  relating  to  the  manufacture  of  pharmaceutical  products  for  exports  to  countries  with  public 
health problems. COM(2004) 737 
Article 58 enables the EMEA to give a scientific opinion, in the context of cooperation with WHO, for 
the evaluation of certain medicinal products for human use intended exclusively for markets outside the 
Community. Regulation (EC) No 726/2004 (31 March 2004), Article 58, OJ L 136, 30.4.2004, p. 1 

EN 

7 

   EN 

 
                                                 
of  impartial  experts  to  provide  technical,  scientific  and  policy  support  for 
partner country regulatory agencies. 

(25)  The  EC  will  support  the  WHO  prequalification  project  in  its  efforts  to 
expand  the  geographical  coverage  and  range  of  products.  In  addition  to 
funding,  EC  support  will  include  the  sharing  of  expertise  and  human 
resources, and targeted support for local production initiatives in developing 
countries  to  upgrade  Good  Manufacturing  Practices  and  submit  proposals 
(bioequivalence and stability studies). 

3.3. 

Addressing the human resource crisis for health providers 

(26)  The  lack  of  trained  health  providers  undermines  efforts  to  scale  up  the 
provision  of  prevention,  treatment  and  care  services.  The  EU  will  support  a 
set of innovative responses to the human resource crisis. At regional level, 
the EC will use its support for the AU and the New Partnership for Africa’s 
Development  (NEPAD)  to  help  ensure  strong  African  leadership  in  the 
formulation and coordination of a response to the human resource crisis. The 
aim should be to increase incentives for health workers to remain in or return 
to  developing  countries  or  regions  where  the  need  is  greatest  rather  than  to 
create  barriers  to  migration.  Actions  will  include  strengthening  AU  and 
NEPAD  capacity  to  map  the  scale  of  the  problem  and  facilitate  regional 
dialogue  on  country,  regional  and  global  action  needed  to  increase  training 
and  to  retain  and  sustain  increased  human  resource  capacity.  Improved 
opportunities for research may also help to prevent brain drain. Engaging the 
local communities in research activities, which could contribute to improving 
the overall level of health care, will also be encouraged. Strengthened synergy 
between  EC  supported  research  and  health  resources  at  local  and  regional 
level can further help improving health care. 

(27)  By  2006,  the  EC  will  present  a  policy  document  on  human  resources 
within  the  broader  health  context,  which  will  help  to  formulate  specific 
measures  and  thus  also  have  an  impact  on  the  implementation  of  this  PfA. 
This strategy will include a discussion of the following topics: 

– 

– 

– 

– 

a  European  Code  for  ethical  recruitment  practice,  drawing  upon  and 
learning from experience in EU MSs with voluntary codes; 

compensation  for  partner  countries  (e.g.  through  taxation  by  the  EU 
MSs on recruitment) to make up for the recruitment of trained nationals 
from countries with a human resource crisis; 

supporting  the  development  of  national  plans  for  human  resources 
through policy dialogue on sectors, CSPs and PRSPs; and 

a  Declaration  of  Global  Solidarity,  issued  by  the  Council  and  the  EU 
MSs,  stating  the  key  principles  and  objectives  for  supporting  action  on 
human resources in the health crisis. 

EN 

8 

   EN 

 
3.4. 

New tools and interventions 

(28)  The  EC  will  support  the  research  and  development  of  new  tools  and 
interventions  through  projects  designed  to  accelerate  the  development  of 
new  vaccines,  drugs,  microbicides  and  diagnostic  tools  for  resource-poor 
settings. The EC will encourage the participation of research organisations 
and institutions from disease-endemic countries in collaborative research 
projects  with  European  partners.  The  EC  will  provide  support  for  the 
EDCTP  while  urging  European  countries,  private  charities  and  industry  to 
provide  significant  funding  and  expertise  for  this  initiative.  In  its  dialogue 
with  participating  countries  and  companies,  the  EC  will  advocate  the 
inclusion  of  clauses  on  affordability,  intellectual  property  rights  (IPR), 
manufacturing  and  regulatory  approval.  The  EC  will  provide  support  for 
social-behavioural  research,  epidemiology  and  operational,  health-
systems  and  applied  research,  and  cost  projection  studies  –  including 
community  capacity  and  preparedness  to  participate  in  clinical  trials  and  to 
introduce new tools and interventions rapidly, once developed and approved. 

(29)  The  EU  will  undertake  studies  to  establish  a  priority  list  of  “pull 
incentives”  to  engage  private  industry  in  the  research  and  development  of 
new  tools  and  interventions,  based  on  a  cost-benefit  analysis  and  on  their 
feasibility.  The  studies  should,  in  particular,  analyse  advanced  markets 
mechanisms, cash premiums, an international financing facility for vaccines, 
and transferable privileges – such as IPR extensions or fast-track approvals. 

(30)  The  EC  will  support  a  selected  number  of  public-private  partnerships 
(PPPs),  and  global  initiatives.  The  aim  will  be  to  establish  the  coordination 
and synergy that are necessary and the appropriate level of resources required 
to  accelerate  R&D  efforts,  to  estimate  the  health,  social  and  economic 
benefits  that  could  be  derived  from  the  development  and  use  of  new 
to  prepare 
diagnostic,  preventive  and 
communities  for  the  introduction  of  HIV/AIDS  vaccines  and  microbicides. 
The  EC  will  enhance  cooperation  within  Europe  to  ensure  the  viability  and 
progress  of  innovative  research  initiatives  towards  the  development  of 
priority products. 

technologies,  and 

therapeutic 

3.5. 

Strengthened partnerships 

The  EC  will  consult  and  involve  a  wide  group  of  partners  in  ongoing  dialogue 
through  the  EC  Stakeholder  Forum  and  regional  consultations.  The  Stakeholder 
Forum will invite representatives of civil society, including people directly affected 
by the three diseases to enhance their role and voice in the policy dialogue at global 
level.  The  involvement  of  the  private  sector,  including  industry  (e.g.  Private 
Investors for Africa) and private foundations, remains crucial. 

The  EC  will  collaborate  with  and  further  support  key  organisations  and  global 
initiatives through effective global partnerships sharing efforts, risks and benefits to 
translate  a  common  vision  into  a  common  voice  and  common  action.  The  EC  will 
assess  the  relative  merits  of  working  in  global  partnerships  by  assessing  what  the 
partnership offers in terms of: 

EN 

9 

   EN 

 
•  unique  expertise,  wide  presence  in  countries,  key  resources  that  make  it  a 

particularly useful partner to make EU action more effective and efficient; 

•  whether the benefits for the EU outweigh the input in terms of resources, staff 

and time; and 

•  whether  the  EC  as  an  organisation  offers  the  partner  specific  comparative 
advantages and what the position of EU MSs is towards the potential partner. 

In addition to the stakeholders mentioned under 3.4, and based on an assessment of 
these  three  criteria,  the  EC  proposes  to  work  with  the  following  partners  at  global 
level.  WHO  (under  the  EC-WHO  strategic  partnership)  and  UNAIDS  –  are  key 
partners  for  the  EC.  These  organisations  offer  both  technical  expertise,  e.g.  on 
pharmaceutical policy, regulatory issues and health monitoring, and disease-specific 
expertise  through  RBM  and  Stop  TB.  The  EC  will  also  cooperate  closely  with 
UNFPA  to  ensure  that  synergies  are  explored  between  initiatives  in  this  field  and 
those  focusing  on  the  Cairo  agenda,  with  ILO,  under  the  EC-ILO  strategic 
partnership, and with UNICEF on mother-and-child health and education issues. 

3.6. 

A strong European voice 

The EC has a strong role and responsibility, together with the EU MSs, in terms of 
establishing,  representing  and  defending  the  European  vision  and  commitments 
internationally.  Political  dialogue  with  countries  is  crucial  to  addressing  and 
defending  basic  principles  and  to  raising  and  discussing  sensitive  issues  at  the 
highest political level. 

At global level, the EC voice may be due to a formal mandate, e.g. in trade policy, or 
to the EC taking the initiative or being asked by EU MSs to take on such a role. This 
is  sometimes  also  the  case  in  UN  processes,  where  it  is  the  EU  MSs  that  are  fully 
represented  and  have  a  formal  voice.  Examples  include  preparations  of  UNGASS, 
follow-up to the MDGs, and UN conferences on gender equality and SRHR – all of 
which  are  intimately  linked  to  the  policy  issues  discussed  in  this  PfA.  The  EC  can 
play  a  constructive  role  both  by  projecting  and  defending  an  EU  position 
internationally  and  by  offering  non-EU  members  a  credible  partner  for  dialogue. 
Close cooperation between the EC and EU MSs remains crucial in the UN as well as 
in the G8 context. The EC also needs to be able to co-fund international conferences 
and seminars where progress is assessed and new policy and practice discussed. 

4. 

NEXT STEPS 

Programming decisions and budget allocations with respect to actions proposed in 
this PfA will be made in accordance with the structure of instruments determined for 
the next financial perspectives. 

EU MSs are invited to work closer together  with the EC in  taking specific  actions 
forward at country level, e.g. sharing expertise, reflecting the EU common vision in 
policy  dialogue,  mapping  and  planning  technical  assistance  for  capacity  building, 
and  formulating  joint  measures  to  support  countries  in  addressing  human  resource 

EN 

10 

   EN 

 
constraints. The EC will take the decisions required to promote synergy and provide 
a coherent response to the three diseases across relevant policy areas. 

The  EC  will  monitor  and  report  on  the  implementation  through  annual  and  mid-
term  reviews  of  country  specific  instruments,  FP7,  and  monitoring  and  evaluation 
mechanisms of the Global Fund. The EC will work towards agreement with partners 
in  countries  on  the  use  of  one  monitoring  and  evaluation  framework  with  common 
indicators. In 2008 and 2010, the Commission will present comprehensive progress 
reports to Parliament and the Council on the implementation, outputs and impact of 
the PfA. 

EN 

11 

   EN 

 
Annex 1 – Principles for country strategies to confront the three diseases 

Civil society, in particular people infected and affected by the diseases, together with 
representatives of the social partners and the private sector should be active partners 
in policy dialogue, priority setting, and the design, implementation and monitoring of 
strategies. 

Strategies  should  be  evidence-based  and  represent  an  appropriate  policy-mix, 
including information, prevention (e.g. condoms and LL-ITNs), harm reduction (e.g. 
needle  exchange  for  injecting  drug  users),  vector  control  measures  against  malaria 
(e.g.  environmental  and  sanitation  measures  and  intra-door  residual  spraying  with 
DDT), treatment and care, and impact alleviation. Information and prevention remain 
crucial components of any strategy aiming to halt the spread of HIV/AIDS, malaria 
and  TB.  These  strategies  should  also  help  to  increase  human  security  and  the 
protection  of  human  rights  –  including  women’s  rights  and  the  rights  of  the  child. 
They should also help to overcome stigma and discrimination among those infected 
and affected, including groups at higher risk of HIV/AIDS infection e.g. commercial 
sex  workers,  men  having  sex  with  men,  injecting  drug  users  and  prisoners,  and 
protect the rights of such people while at the same time providing access to essential 
services based on equity. 

The translation of policies into strategies requires sufficient and predictable financing 
based  on  solid  costing  and  gap  analyses,  adequate  allocation  of  domestic  resources 
according to capacities and topping-up by external aid to support the strategy. 

Strategies should be cross-sectoral and be both an integrated part of, and reflected in 
comprehensive  actions  for  developing  health  and  other  social  services  to  improve 
health outcomes. Synergies should be explored with strategies to promote SRHR and 
gender equality. All sectors should consider the impact of the three diseases and how 
their sector can contribute through an appropriate response. 

Inclusion  of  strategies  into  MDG-based  poverty  reduction  programmes  should  be 
promoted in developing countries. 

Gender equality should be promoted through these strategies, and reflect the fact that 
girls and women carry a heavier burden and are affected more often and at an earlier 
age by HIV/AIDS than men. HIV/AIDS strategies must be designed to address the 
constraints that make it difficult for girls to use prevention tools, treatment and care 
services.  The  role  and  responsibilities  of  men  in  HIV/AIDS  prevention  should  also 
be highlighted, including in terms of norms and responsible sexual behaviour. 

Strategies should reflect the fact that family-based and community-based care often 
plays  a  crucial  role  in  alleviating  the  burden  of  the  disease,  including  as  an 
alternative  to  institutional  care  for  orphans  and  vulnerable  children.  The  age 
dimension  also  needs  to  be  taken  into  account,  with  a  particular  focus  on  children 
affected  by  malaria,  orphans  and  vulnerable  children  affected  by  HIV/AIDS  and 
elderly people who have higher rates of TB infection (often undiagnosed) and who 
are also often left to take care of such children and may need support to this end in 
terms of social protection or allowances. Inheritance and social rights for widows and 
orphans need to be protected through legislation and put into effective practice. 

EN 

12 

   EN 

 
Strategies should address other specific vulnerable groups, e.g. workers in unhealthy 
environments, refugees, migrants, internally displaced people, minority communities, 
and people with disabilities, who are often placed in vulnerable situations. 

EN 

13 

   EN 

 
Annex 2 – Indicative monitoring framework for actions 2007-2011 

PARTNERS 

MONITORING AND OUTCOMES 

ACTION/ 
INITIATIVE 
COUNTRY ACTION 
Political dialogue 

1. 

2.  Develop  a 

toolkit 

programming 
for 

for  policy 
dialogue, 
and 
EC/EU 
monitoring 
delegations;  and  for  awareness 
raising 
at 
headquarters (HQ) 
Sharing  health  expertise  between 
EU MSs 

training 

and 

EC 
EU MSs 
EC 
EU MSs 
WHO (+UNAIDS, RBM, 
StopTB) 

EC Delegations, EU MSs 

Social  responsibility  for  EC  staff 
and their families 

EU MSs 
ILO 

Sharing  resources  for  technical 
assistance 

EC 
EU MSs 
WHO (+UNAIDS, RBM, 
StopTB) 

3. 

4. 

5. 

- Political dialogue on key issues relating to leadership, governance, human rights, vulnerable groups, 
and stigma and discrimination. 
- Toolkit prepared and distributed to Delegations. 
- Training at HQs organised. 
- HIV/AIDS, malaria and TB, including the critical issues, raised in the dialogue in more countries; 
reports by social sector experts. 
- HIV/Malaria/TB analysis, where relevant, included in CSP programming and review exercises. 

- Mapping of EC/EU health experts. 
- Arrangements for joint working or sharing of EU health expertise. 
- EU health experts present in policy and political dialogue in PRSP, health sector, and disease-specific 
reviews, as reported annually by EC Delegations. 
- Shared situation analysis, programming, monitoring and reporting increasingly used. 
- Development of a joint framework for analysis and reporting. 

- Education and prevention programmes in EC delegations. 
- Adequate social protection schemes for EC Delegations and RELEX services, which support staff and 
their families affected by the diseases, in line with good practice developed by EU Member State 
development agencies. 
- Plan for shared TA and code of conduct agreed in countries with high presence of EU donors, based 
on mapping of resource persons. 

EN 

14 
EN 

 
 
 
 
 
 
 
 
PARTNERS 

MONITORING AND OUTCOMES 

6. 

ACTION/ 
INITIATIVE 
Supporting 
human 
resources  for  health  policy  and 
strategies  which 
build  HR 
capacity 

national 

7.  Building  capacity 

for  clinical 

research 

EC Delegations (in particular 
in countries with EC sector 
or macroeconomic budget 
support) 
EU MSs and their health 
professions councils 
Dialogue with IMF, AU, 
NEPAD 
EC 
EU MSs 
EDCTP 

8.  Building 

capacity 

for 

pharmaceutical policy 

WHO (+UNAIDS, RBM, 
StopTB) 

WHO (+UNAIDS, RBM, 
StopTB) 

10. 

9.  Building 

capacity 

for 
procurement  of  pharmaceutical 
products and commodities 
Increase 
between 
synergy 
programmes  and  services  on  the 
three  diseases  and  for  children’s 
rights and health, and sexual and 
reproductive health 

- Incentives and strategies developed and supported by the EU to retain health providers and to 
strengthen research capacities through training of professionals and the creation of more attractive 
career conditions and perspectives. 
- Bretton Woods institutions acknowledging the exceptional situation in terms of human resources in 
the health sector and contributing to an enabling environment to address this. 

- Capacity increased for research (social, clinical, operational), including training of human resources, 
in several African countries with heavy burden for the three diseases and accompanied by adequate 
institutional capacity strengthening. 
- Support by EC, EU MSs, EDCTP and other global stakeholders for further scientific and technical 
cooperation between health care and health research, complementing EC supported clinical trials 
activities. 
- Support provided through WHO, including on the following key issues on pharmaceutical policy: , 
including Multi-Drug Resistant TB; substitution therapy for injecting drug users; affordable, rational 
and supervised use of relevant malaria treatment, including Artemisinin-based combination therapy; 
provision of second-line treatment for HIV/AIDS; treatment guidelines for women of reproductive age 
and children; and guidance on drug quality. 
- Improved and more rational use of pharmaceutical products in developing countries. 
- Prices on pharmaceutical products and SRH commodities published. 
- Lowest prices paid by least developed countries by end of 2011, as seen from prices published. 

EC 
EU MSs 

- Child health programmes and SRH services increasingly providing information and preventive 
commodities for the three diseases. 

11.  Making  schools  safe  for  children 
and  including  prevention  of  the 
three diseases in curricula 

International organisations, 
e.g. UNICEF and UNFPA, 
and teachers and parent 
organisations 

- School safety raised in policy and political dialogue, reports by EC delegations with education as 
focal sector, taking into account the work done by e.g. UNICEF and UNFPA on rights-based, child-
friendly schools and involve children, parents and teachers in their design and implementation. 
- Codes of conduct established and respected by teachers. 

EN 

15 
EN 

 
 
 
 
 
PARTNERS 

MONITORING AND OUTCOMES 

ACTION/ 
INITIATIVE 

12.  Assessing  the  impact  of  the  three 
diseases  on  human  security  and 
stability at state level 

13.  Mainstreaming 

to 
confront  the  three  diseases  in 
emergency operations 

efforts 

EC 

EC 

14.  Training  of  peacekeeping  forces 
to confront the three diseases 

15.  Collecting  of  relevant  data  for 
annual  monitoring  of  progress 
indicators13 

EC 
AU 
EU MSs 
EU MSs 
WHO (+UNAIDS, RBM, 
StopTB) 
Health Metrics Network 

16.  Financial  resources  to  confront 

the three diseases 

EU MS 
GLOBAL FUND 

17.  Highly cost-effective 

interventions likely to yield rapid 
results 

18.  Promoting  MDG-6 

focused 

PRSPs 

UNICEF 
UNFPA 
WHO/UNAIDS 
Other agencies 
EC 
EC Delegations 
EU MSs 

- Study on human security and stability. 
- EU response proposed for critical countries. 

- ECHO guidelines for HIV/AIDS and malaria finalised. 
- Training and tools provided for humanitarian workers. 
- The three diseases addressed in the situation of CSPs subject to LRRD. 
-Accompanying measures of EC support for the AU Peace facility. 

- Sex- and age-disaggregated data collected and analysed to monitor meaningful indicators on the three 
diseases. 
- Capacity of national monitoring and reporting systems strengthened, including to monitor essential 
services. 

- Adequate and predictable funding of the Global Fund, including a significant EU contribution. 

- EC support and funding provided for these interventions through relevant organisations in partnership 
with heavy-burden countries. 

- MDG rating analysis for PRSPs developed. 
- PRSPs increasingly focused on achieving the MDGs with increased resources allocated to MDG6. 

13 

Examples  include:  Voluntary  Counselling  and  Testing  (VCT)  coverage,  Prevention  of  Mother-To-Child  Transmission  (PMTCT)  coverage,  and  Highly  Active  Anti-
Retroviral  Therapy  (HAART)  coverage  (for  HIV/AIDS);  use  of  LL-ITNs  for  under-fives  and  pregnant  women,  and  Intermittent  Preventive  Treatment  (IPT)  during 
pregnancy and possibly childhood (for malaria); and DOTS detection and cure rate (for TB). 

EN 

16 
EN 

 
 
 
 
 
 
                                                 
PARTNERS 

MONITORING AND OUTCOMES 

EC 

- EC regional health advisors appointed. 
- Annual regional reports on country actions. 
- Regional cooperation established on key issues and examples of good practice shared. 

ACTION/ 
INITIATIVE 
GLOBAL ACTION 

19.  Strengthening 

regional 
cooperation  to  confront  the  three 
diseases  in  Southern  Africa  and 
South-East  Asia,  expanding  to 
other regions 

20.  Monitoring and promoting of the 

anti-trade diversion Regulation 

21.  Promoting price transparency 

22. 

Implementing  the  August  2003 
decision of the WTO 

23.  Developing 

and 
regulatory  capacity  of  partner 
countries 

scientific 

EC 
Dialogue with industry 
WHO (including RBM and 
StopTB) and UNAIDS 
MSF 
GLOBAL FUND 
(see action point 9) 
EC 
EU MSs, 
Dialogue with WTO 
EC 
WHO, EMEA, EU MSs 
Regulatory bodies 

24.  Establishing  regional  schemes  of 
mutual recognition for marketing 
authorisation 
Setting  up 
international 
an 
advisory committee on regulatory 
matters 

EC 
AU, WHO 

EN 

- Monitoring reports published with meaningful and transparent price data. 

- Prices of pharmaceutical products and commodities purchased through EC support published. 

- EC legislation to implement the August Decision adopted by Council and Parliament. 
- August Decision fully incorporated into the TRIPs Agreement through a formal amendment. 
- Biannual report of implementation of the August agreement in third countries. 
- Use of Article 58 of Regulation (EC) No 726/2004 for the evaluation of medicines for developing 
countries. 
- Specific guidelines developed on key products, e.g. microbicides and vaccines – consistent with the 
risk-benefit profile of products in the country context, and age and gender aspects when assessing 
safety and efficacy. Support will be given through TA, training and exchange schemes. 
- Training on regulatory capacity provided by experts under EC Framework contract and/or WHO. 
- International conference organised by EMEA and WHO focusing on regulatory issues relating to 
microbicides. 
- Regional capacity developed in terms of centres of regulatory expertise. 
- Regional scheme of mutual recognition for marketing authorisation established. 

- Needs and opportunities for setting up an international advisory committee fully explored. 

17 
EN 

 
 
 
 
 
 
 
 
 
 
ACTION/ 
INITIATIVE 

25.  Support 

for 

WHO 

prequalification project 

26. 

responses 

the 
Innovative 
human  resource  crisis  among 
health providers 

to 

27.  Preparing  new  EC  policy  on  a 
European  response  to the human 
resource  crisis  among  health 
providers 

PARTNERS 

MONITORING AND OUTCOMES 

EC 
EIB 
WHO 
EU MSs, 
AU, NEPAD, HL Forum on 
the Health MDGs 
EC 

- Continued and expanded EC funding for the WHO prequalification project. 
- Annual report on prequalification progress in relation to production map in developing countries. 

- EC support for AU-NEPAD in tackling the human resource crisis, ultimately leading to increased 
training, improved working conditions and better availability of health providers in Africa. 

- EC Communication on “HR-diversion” adopted and ways forward explored with EU MSs. 

28.  Supporting 

research 

and 
development of priority tools and 
interventions,  including  clinical 
trials and non-medical research 

EC 
EU MSs 
Private sector 

29.  Evaluating  the  effectiveness  and 
potential  cost  of  implementing 
pull 
incentives  within  EC 
competence 

EC 

- EC funding leading to results in terms of new tools and interventions (e.g. EDCTP). 
- Research collaboration with and participation of disease-endemic countries further strengthened, 
through excellence centres in disease-endemic countries. 
- Key areas of research (basic, preclinical and clinical) funded under FP7 and results effectively used in 
EC policy development and implementation in the fight against the three diseases. 
- Studies finalised and EC policy proposal in terms of new incentives presented. 

for 

priority 

tools 
30.  Support 
public-private 
through 
partnerships  (PPPs)  and  global 
initiatives 

EC 
EU MSs 
PPPs and global initiatives 

- EC and EU support for PPPs and global initiatives working on priority tools and interventions, e.g. 
HIV/AIDS vaccines and microbicides. 

EN 

18 
EN