Commission staff working document -Executive Summary of Impact Assessment - Accompanying document to the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - Combating HIV/AIDS in the European Union and neighbouring countries, 2009 -2013 {COM(2009) 569 final} {SEC(2009) 1403} {SEC(2009) 1404}
Date: 2009-10-26
Institutions: European Commission
Subjects: AIDS, action programme, anti-discriminatory measure, cooperation policy, disease prevention, health policy, impact study, right to health, third country

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.10.2009 
SEC(2009) 1405 final 

COMMISSION STAFF WORKING DOCUMENT 

Executive Summary of Impact Assessment 

Accompanying document to the 

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

Combating HIV/AIDS in the European Union and neighbouring countries, 2009 -2013 

{COM(2009) 569 final} 
{SEC(2009) 1403} 
{SEC(2009) 1404} 

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1. 

PROBLEM DEFINITION 

In view of the latest findings on HIV/AIDS, preliminary assessment of the 2006-2009 Action 
Plan, and stakeholder consultations, these are the issues for future action: 

1.1. 

Political commitments have not been achieved 

Despite  some  progress,  certain  agreed  political  commitments  have  not  yet  been  met.  The 
international community still supports agreed targets and realisable goals (universal access to 
prevention,  treatment,  care  and  support),  but  civil  society  is  not  systematically  involved  in 
policy development, implementation and monitoring in all Member States and neighbouring 
countries. 

1.2. 

Data gaps in the centralised EU monitoring and reporting system  

The ECDC has made progress in surveillance work on HIV/AIDS. But to obtain a complete 
picture  of  the  epidemic,  surveillance  requires  even  more  complete,  comparable  and 
compatible data.  

1.3. 

Imperfect  prevention  and  treatment  activities  and  potentially  diminishing 
health budgets 

Prevention strategies are still not sufficiently effective. There are still large numbers of people 
living  with  HIV/AIDS  (PLWHA)  in  Europe  who  have  not  yet  been  diagnosed.  Counselling 
and  voluntary  testing  are  important  instruments  of  HIV  prevention,  but  they  are  not  yet 
available  throughout  Europe.  The  same  applies  to  access  to  treatment,  care  and  support. 
Policies have to be targeted towards the particularly affected groups (e.g. injecting drug users 
(IDU), men having sex with men (MSM), and immigrants from high-prevalence regions). 

The disease has changed from a deadly threat to a chronic condition, and support still varies 
across Europe and neighbourhood, and is far from universal1. Persisting knowledge gaps 

Knowledge gaps persist in: 

Social science and especially the behavioural aspects of HIV transmission,  

(i) 
(ii)  Socio-economic analysis on the cost-effectiveness of prevention, 
(iii)  The development and use of novel prevention technologies, 
(iv)  The cross-border dimension in the EU and neighbouring countries, 
Intensified biomedical research on treatments and vaccines. 
(v) 

1.4.  Worrying trends in several Eastern European countries 

Eastern  Europe  (Baltic  Member  States,  Ukraine,  Republic  of  Moldova;  and  the  Russian 
Federation) is one of the regions of the world with an alarming spread of HIV, often with co-
infections such as (multi-drug resistant) tuberculosis or hepatitis.  

2. 

THE RATIONALE FOR EUROPEAN ACTION 

Addressing  the  HIV/AIDS  challenge  at  EU  level  is  part  of  overall  health  and  social  policy, 
focusing  on  prevention  and  new  strategies  aimed  at  PLWHA  and  populations  at  risk,  to 
reduce the spread of infections into the EU. 

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Costs for antiretroviral HIV treatment and treatment of AIDS-related symptoms can be significant, and ARV costs 
are only a fraction of total treatment and follow-up costs for people with progressive disease. 

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2.1. 

Subsidiarity 

EU  Member  States  and  neighbouring  countries  have  the  prime  responsibility  for  protecting 
and  improving  the  health  of  their  citizens.  Article  152  EC  requires  a  high  level  of  human 
health protection in the definition and implementation of all Community policy and activities.  

2.2. 

Necessity test 

HIV/AIDS is a communicable disease that needs to be addressed by coordinating the efforts 
of  national  governments.  Cross-border  movements  affect  the  spread  of  HIV,  but  free 
movement of persons is a key political pillar of the EU.  

An estimated 64 million migrants from non-EU countries currently live in the EU. Although 
they come from  a  large variety of countries, immigrants to  the  EU  have a  relevant  share of 
new heterosexually transmitted HIV infections. This group is also at risk of social exclusion, 
so may have limited access to testing, prevention, treatment, care and support.  

The  EU  needs  a  harmonised  surveillance  system  to  track  epidemiological  trends  and  assist 
Member  States  in  taking  adequate  public  health  measures.  It  needs  a  common  research 
agenda, to exploiting economies of scale. It is in the EU’s interest to involve the neighbouring 
countries given the high prevalence of HIV/AIDS in some of these countries.  

2.3. 

EU added value  

The  Commission  should  continue  to  play  an  important  role  in  coordinating  efforts  across 
Europe  to  address  HIV/AIDS.  HIV  infections  are  preventable.  The  Commission  provides  a 
solid  fund  of  knowledge,  a  forum  for  discussion  and  exchanges  between  Member  States  to 
promote the transfer of ideas and approaches. Single Member States can hardly maintain this 
kind of cross-border cooperation. 

The  EU  could  mainstream  HIV  as  a  public  health  challenge  across  relevant  EU  policies, 
especially free movement of people, human rights, research and non-discrimination. Countries 
may benefit if they attune their own policies to European good practice. 

3. 

POLICY OBJECTIVES 

The  general  objective  is  to  contribute  to  the  prevention  and  reduction  of  human  illness  and 
diseases stemming from HIV infections, to obviate sources of danger to human health, as laid 
down in Article 152 of the Treaty and to improve the quality of life of PLWHA and most at 
risk of infection.  

3.1. 

Specific objectives:  

(a) 

(b) 

(c) 

To  maintain  political 
involvement  

leadership  and  stakeholders  commitment  and 

To improve HIV/AIDS epidemiological data by monitoring  

To  support  EU  Member  States  and  neighbourhood  countries,  in  developing 
public health interventions to: 

– 

– 

– 

focus national strategies on populations most at risk, 

improve living conditions of vulnerable people at high risk of HIV, and 
ensure universal access to prevention, treatment, care and support  

adapt national strategies to address unmet challenges (under-diagnosis, 
new prevention methods, new treatment options etc.) 

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– 

despite  the  current  economic  crisis,  ensure  that  sufficient  funding  is 
allocated to HIV/AIDS 

(d) 

To  address  knowledge  gaps 
treatment,  vaccine  and  microbicide 
development,  public  health  research,  behavioural  science,  socio-economic 
analysis.  

in 

4. 

POLICY OPTIONS 

To attain the above objectives, three different options were compared. 

4.1. 

Option  1:  Baseline  —  continued  implementation  of  current  action  plan,  and 
evaluation 

The initial ‘baseline option’ would extend the lifespan of the current action plan and continue 
the  implementation  of  open  actions.  This  would  maintain  the  political  backing  of  the  EU, 
allowing  the  Commission  and  stakeholders  to  complete  activities  still  in  progress  and  to 
continue  with  successful  activities.  Indicators  could  be  introduced  to  monitor  results,  for  a 
comprehensive  evaluation  of  the  current  action  plan.  Surveillance  and  research  would 
continue, based on existing priorities and instruments. 

4.2. 

Option 2: No EU policy or action plan on HIV/AIDS  

The Commission would  not  opt  for  a new policy  initiative on HIV/AIDS. The Commission 
would  focus  on  existing  funding  activities/programmes,  such  as  the  Research  Programmes, 
the Health Programme, European Social Fund, European Neighbourhood Policy Instruments 
(ENPI), external HIV policies, and on technical support through specialised agencies such as 
ECDC or EMCDDA. But without a new EU action plan on HIV/AIDS, HIV-related spending 
could  be  re-allocated.  Surveillance  by  ECDC  would  continue  without  alignment  to  new, 
agreed policy needs. 

4.3. 

Option 3: Current plus — a new Commission policy and action plan  

The  Commission  would  provide  renewed  political  impetus  to  keep  HIV/AIDS  on  political 
agendas.  It  would  set  out  the  main  policy  priorities  for  the  fight  against  HIV/AIDS  across 
Europe. A new Commission policy could provide the broad action lines and the Commission 
services  and  stakeholders,  meeting  in  the  Think  Tank  and  the  Civil  Society  Forum,  could 
refine  an  operational  action  plan,  with  indicators  to  measure  progress.  This  option  would 
respond  to  the  new  trends  and  challenges  identified  (prevention,  priority  regions,  priority 
groups). EU and stakeholder activities would build on the first EU action plan 2006-2009 and 
adjust the emphasis to relevant areas such as prevention, treatment and research. 

4.4. 

Option 4: Discarded options 

Legislation:  HIV/AIDS  is  a  health  and  social  problem  with  a  considerable  political 
dimension,  but  there  is  no  basis  in  the  Treaty  for  a  HIV-specific  directive  or  regulation. 
Member States and neighbouring countries design their national plans and programmes; but 
national  approaches  benefit  greatly  from  sharing  best  practices,  experiences  and  evidence-
based solutions. 

Campaign:  A  European  campaign  on  HIV  could  not  take  account  of  all  situations  and 
cultural  sensitivities  throughout  Europe.  It  would  not  work  for  all  populations  at  risk,  and 
would therefore not be cost-effective or efficient. 

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5. 

ANALYSIS OF IMPACT 

5.1. 

Option 1: Baseline option — continued implementation of current action plan  

Economic impact 

The direct costs for the EU would probably be similar to the previous period (2006-2009). 
The evaluation included in this option would gauge the impact of EU and national efforts on 
the epidemic. 

This option would demonstrate continuity and would encourage continued high investment by 
multiple stakeholders. 

Spending  for  activities  financed  through  national  budgets  would  probably  remain  stable 
compared  to  2006-2009.  None  of  the  activities  in  the  action  plan  would  be  binding  on  any 
party.  

An  agreed  action  plan,  backed  up  by  strong  political  commitment,  effective  sharing  of  best 
practices,  and  a  solid  fund  of  knowledge,  would  reduce  inefficiencies  and  duplication  of 
efforts and could support planning at national level. 

However, in an economic downturn, national spending on health is expected to be cut back, 
especially in the short and medium term. There is a risk that HIV/AIDS-related expenditure 
could  follow  this  trend.  No  additional  MS  costs  are  expected  for  reporting,  as  the  ECDC 
surveillance is financed from the EU budget. 

Social impact 

This  option  should  improve  access  to  prevention,  treatment  and  care  and,  in  turn,  have  a 
positive  social  impact.  Indeed,  effective  prevention  programmes  help  to  reduce  further 
transmission  of  HIV.  Prevention,  earlier  diagnosis  and  treatment  can  halt  or  delay  the 
progression of the disease and keep sufferers in work, which may improve the quality of 
life of PLWHA. 

ECDC surveillance would not meet new challenges and data needs without a new EU policy.  

5.2. 

Option 2: No EU policy or action plan on HIV/AIDS  

Economic impact 

The  direct  costs  for  the  EU  would  probably  fall,  but  not  greatly.  Political  and  financial 
support  might  be  less  effective,  due  to  a  lack  of  political  guidance  in  setting  priorities. 
Absence  of  political  motivation  for  EU  cooperation  on  HIV/AIDS  could  affect  the 
programmes’ annual priorities and favour other non-HIV/AIDS priorities which are supported 
by an EU policy. With 2.7 million new HIV infections annually worldwide, and the need for a 
vaccination or cure, this appears difficult to justify. 

Reduced  emphasis  on  HIV/AIDS  as  a  priority  would  also  have  serious  repercussions  on 
multiple stakeholders engaged in research, service provision, training and support activities. 
In an economic crisis, the lack of political commitment at EU level would not necessarily be 
compensated by bilateral or multilateral cooperation without EU participation.  

The  key  drawback  is  the  political  message  that  this  would  send.  HIV/AIDS  prevention 
programmes  are  particularly  vulnerable  to  health  budget  cuts.  Less  prevention  could  make 
health  costs  increase,  with  more  infections  and  higher  treatment  costs,  as  well  as  social, 
economic  and  labour  market  effects.  No  additional  costs  for  MS  for  reporting  and 
surveillance are to be expected.  

Social impact 

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This  option  bears  the  risk  that  without  political  support  from  the  Commission,  HIV/AIDS 
might disappear from the radar screens of certain funding mechanisms. 

It  is  difficult  to  tell  what  additional  action would  be  taken  by  MS  and  stakeholders  without 
EU political guidance. It may be assumed that internationally agreed targets would not be 
reached in all European countries. That could lead to adverse social impacts and an increase 
in HIV/AIDS.  

There  would  be  less  potential  to  empower  NGOs  that  protect  vulnerable  groups  in  the  EU 
and neighbouring countries.  

This option may not be effective enough to sustain cooperation across Europe, specifically to 
steer  action  towards  the  new  challenges,  or  to  address  the  social  issues.  As  in  the  case  of 
Option 1, ECDC surveillance would not cover the new challenges and data needs. 

5.3. 

Option 3: Current plus — a new EU policy and action plan  

Economic impact 

Under this option, the tasks for implementing the new action plan would be distributed among 
all stakeholders involved.  

The direct costs for the EU would probably be similar to the previous period (2006-2009). 
With political support and an increased focus on new challenges and trends, the effects could 
improve  and  resources  could  be  reallocated  towards  more  efficient  action.  The  planned 
evaluation would help to gauge the impact of EU and national efforts on the epidemic. This 
option  maintains  HIV/AIDS  as  a  priority  at  the  EU  level,  emphasising  continuity  and 
providing an incentive for multiple stakeholders engaged in research, services, training etc. 

Under  this  option,  spending  for  activities  financed  through  national  budgets  would 
probably remain stable, as compared to 2006-2009. None of the activities would be binding 
on any party. However, the emphasis on new priorities could lead to reallocation of national 
resources to new preventive methods, more targeting at the most-at-risk groups and stronger 
eastern cross-border cooperation, resulting in more cost-effective action. 

The  economic  downturn  could  affect  HIV/AIDS-related  aid  and  threaten  prevention 
programmes with potential health budgets cuts. Option 3 would give an incentive for EU MSs 
and  neighbouring  countries  to  maintain  public  spending  targeted at  most-at-risk  populations 
and allocate resources to the most cost-effective health interventions.  

Improved reporting and surveillance may impose additional costs on the very few countries 
not already sending sufficient data to ECDC. For other countries, there would be no additional 
burden.  They  will  benefit  from  better  planning  based  on  better  data  —  this  is  usually  cost-
effective. 

Social impact 

A Commission communication and action plan would underline continuity and political will 
to achieve existing international commitments. It would lay down precise targets and could 
result in better resource allocation and more effective infrastructures at a national level. 

Option 3 should have a positive impact on civil society, people affected by HIV/AIDS and 
industry.  Through  stronger  political  leadership  and  civil  society  involvement,  it  should 
improve living conditions for all people affected by the disease.  

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This option would: 

–  support  efforts  to  address  the  social  issues  around  HIV/AIDS,  related  to  stigma, 

discrimination, and non-respect of human rights 

–  empower civil society, which is indispensable in fighting HIV/AIDS  

–  monitor  the  scale  of  the  epidemic  and  co-infections,  such  as  tuberculosis,  hepatitis  and 

sexually transmitted infections, at national and cross-border level 

–  improve the response to it  

–  bring together experts to plan responses to future challenges.  

Improved  surveillance  and  monitoring  at  European  level,  mostly  by  ECDC  and  other 
specialised and norm-setting bodies, would strengthen the basis for effective and sustainable 
public health measures. 

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The following table summarises the impact of the three options on the specific objectives. 

Specific objectives 

Option 1 

Option 2 

Option 3 

Political leadership and guidance towards agreed targets 

Strengthened surveillance and epidemiology to support policy  

Increase MS and neighbouring countries’ focus on most-at-risk

Encourage  MSs  and  neighbouring  countries  to  improve  living
conditions for people at high risk of HIV and ensure universal
access to high-quality care and treatment services 

Encourage MSs and neighbouring countries to adapt HIV/AIDS
strategies to non-resolved and/or new challenges  

Encourage  MSs  and  neighbouring  countries  to  protect public
and private anti-HIV/AIDS funding despite economic crisis 

Fill research gaps by integrating resources and activities 

+ 

+ 

+ 

+ 

+ 

+ 

+ 

- 

+ 

- 

- 

- 

- 

+ 

++ 

++ 

++ 

++ 

++ 

++ 

++ 

Costs of specific objectives 

Budgetary impact for the EU: 

Health Programme 

All figures are approximate estimates 

€20M  

€20M or less, 
reallocation of 
HIV funding to 
other HP policies 

€20M  
reallocation to new 
action plan 
priorities  

Research Framework Programme 

 €100M  

 €100M or less, 

reallocation of 
HIV funding  

ECDC (surveillance and monitoring) 

 €4.4M  

 €4.4M  

 €100M  
reallocation to new 
priorities  

 €4.4M  
reallocation to new 
priorities  

Budgetary impact for MSs:  

Costs for health and research budgets 

Costs of reporting (surveillance) 

n/a 
stable 

n/a 
risk of budget 
cuts, due to 
economic crisis 

n/a 
stable 
reallocation to new 
priorities  

no additional 
administrative
burden for 
EU MSs  

no additional 
administrative 
burden for EU 
MSs 

administrative 
costs due to new 
data reporting 
requirements  

Based on the impact assessment carried out, Option 3, a new Commission policy and action plan, 
would have the biggest impact, and thus is the preferred option. 

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6. 

MONITORING AND EVALUATION 

Achievements  could  be  tracked  and  monitoring  reports  could  be  published  by  the 
Commission  by  2012.  Regular  monitoring  encourages  all  stakeholders  to  share  their  results 
and achievements promptly. Best practices and opportunities for cooperation would be more 
accessible to all parties. 

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