EN    EN EN 
 
EN 1   EN  COMMISSION OF THE E UROPEAN 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 CO MMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMI TTEE 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} 
 
EN 2   EN 1. P ROBLEM DEFINITION  
In view of the latest findings on HIV/AIDS , preliminary assessmen t of the 2006-2009 Action 
Plan, and stakeholder consultations, thes e are the issues for future action: 
1.1. Political commitments h ave not been achieved 
Despite some progress, certain agreed politic al commitments have not yet been met. The 
international community still supports agreed targ ets and realisable goals (universal access to 
prevention, treatment, care and su pport), but civil society is not  systematically involved in 
policy development, implementation and monito ring in all Member St ates 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 requi res even more complete, comparable and 
compatible data.  
1.3. Imperfect prevention and treatment ac tivities and potentially diminishing 
health budgets 
Prevention strategies are still not sufficiently e ffective. There are still large numbers of people 
living with HIV/AIDS (PLWHA) in Europe w ho have not yet been diagnosed. Counselling 
and voluntary testing are important instrument s 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 to wards 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 universal
1. Persisting knowledge gaps  
Knowledge gaps persist in: 
(i) Social science and especially the be havioural aspects of HIV transmission,  
(ii) Socio-economic analysis on th e cost-effectiveness of prevention, 
(iii) The development and use of novel prevention technologies, (iv) The cross-border dimension in the EU and neighbouring countries, (v) Intensified biomedical research on treatments and vaccines. 
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. T
HE 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 ai med at PLWHA and populations at risk, to 
reduce the spread of in fections into the EU. 
                                                 
1 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 follo w-up costs for people with progressive disease.  
 
EN 3   EN 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 implemen tation of all Community policy and activities.  
2.2. Necessity test 
HIV/AIDS is a communicable disease that needs to be addressed by co ordinating the efforts 
of national governments. Cross-border moveme nts 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 c ountries currently live in the EU. Although 
they come from a large variety of countries, immi grants 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, pr evention, treatment, care and support.  
The EU needs a harmonised surveillance system to track epidemiological trends and assist 
Member States in taking adequate public he alth 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 HI V/AIDS in some of these countries.  
2.3. EU added value  
The Commission should continue to play an im portant 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. Si ngle Member States can hardly maintain this 
kind of cross-border cooperation. 
The EU could mainstream HIV as a public hea lth challenge across relevant EU policies, 
especially free movement of people, human ri ghts, research and non-discrimination. Countries 
may benefit if they attune their ow n policies to European good practice. 
3. P OLICY OBJECTIVES  
The general objective is to contribute to th e prevention and reduction of human illness and 
diseases stemming from HIV infections, to obviat e sources of danger to human health, as laid 
down in Article 152 of the Treaty and to improv e the quality of life of PLWHA and most at 
risk of infection.  
3.1. Specific objectives:  
(a) To maintain political leadership and stakeholders commitment and 
involvement  
(b) To improve HIV/AIDS epidemio logical data by monitoring  
(c) To support EU Member States and ne ighbourhood countries, in developing 
public health interventions to: 
– focus national strategies on populations most at risk, 
– improve living conditions of vulnerabl e people at high risk of HIV, and 
ensure universal access to prevention, treatment, care and support  
– adapt national strategies to addre ss unmet challenges (under-diagnosis, 
new prevention methods, new treatment options etc.) 
 
EN 4   EN – despite the current econo mic crisis, ensure that  sufficient funding is 
allocated to HIV/AIDS 
(d) To address knowledge gaps in trea tment, vaccine and microbicide 
development, public health  research, behavioural science, socio-economic 
analysis.  
4. P OLICY OPTIONS  
To attain the above objectives, thre e different options were compared.  
4.1. Option 1: Baseline — continued implem entation of current action plan, and 
evaluation 
The initial ‘baseline option’ w ould extend the lifespan of the cu rrent action plan and continue 
the implementation of open actions. This would maintain the political backing of the EU, 
allowing the Commission and stak eholders to complete activities still in progress and to 
continue with successful activities. Indicators co uld be introduced to monitor results, for a 
comprehensive evaluation of the current ac tion plan. Surveillance and research would 
continue, based on existing pr iorities and instruments. 
4.2. Option 2: No EU policy or action plan on HIV/AIDS  
The Commission would not opt for a new pol icy initiative on HIV/AIDS. The Commission 
would focus on existing funding activities/progra mmes, such as the Research Programmes, 
the Health Programme, European Social F und, European Neighbourhood Policy Instruments 
(ENPI), external HIV policies, and on technica l support through specialised agencies such as 
ECDC or EMCDDA. But without a new EU acti on plan on HIV/AIDS, HI V-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 Co mmission 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 polic y could provide the broad act ion lines and the Commission 
services and stakeholders, meeting in the Th ink Tank and the Civil Society Forum, could 
refine an operational action plan, with indica tors to measure progress. This option would 
respond to the new trends and challenges identif ied (prevention, priority regions, priority 
groups). EU and stakeholder act ivities would build on the firs t EU action plan 2006-2009 and 
adjust the emphasis to relevant areas su ch as prevention, treatment and research.  
4.4. Option 4: Discarded options 
Legislation:  HIV/AIDS is a health and social pr oblem with a considerable political 
dimension, but there is no basis in the Treaty  for a HIV-specific dire ctive or regulation. 
Member States and neighbouring countries desi gn their national plans and programmes; but 
national approaches benefit greatly from shar ing 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. 
 
EN 5   EN 5. A NALYSIS 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 finan ced 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 politi cal commitment, effective sharing of best 
practices, and a solid fund of knowledge, woul d reduce inefficiencies and duplication of 
efforts and could support pl anning 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. Ther e is a risk that HIV/AIDS-related expenditure 
could follow this trend. No additional MS co sts are expected for reporting, as the ECDC 
surveillance is financed from the EU budget. 
Social impact  
This option should improve access to preventi on, 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 gr eatly. Political and financial 
support might be less effective, due to a lack of political guidance in  setting priorities. 
Absence of political motivation for EU c ooperation 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 infec tions annually worldwide, and the need for a 
vaccination or cure, this a ppears difficult to justify. 
Reduced emphasis on HIV/AIDS as a priority  would also have serious repercussions on 
multiple stakeholders  engaged in research, se rvice provision, traini ng and support activities. 
In an economic crisis, the lack of po litical commitment at EU level would not necessarily be 
compensated  by bilateral or multilateral coopera tion without EU participation.  
The key drawback is the political me ssage that this would send. HIV/AIDS prevention  
programmes are particularly vu lnerable to health budget cuts. Less prevention could make 
health costs  increase, with more infections and highe r 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  
 
EN 6   EN This option bears the risk that without po litical support from the Commission, HIV/AIDS 
might disappear from the radar scre ens of certain funding mechanisms. 
It is difficult to tell what additional action would be taken by MS a nd stakeholders without 
EU political guidance. It may be assumed that internationally agreed targets  would not be 
reached in all European countries. That could le ad 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 sustai n 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 fo r implementing the new action pl an 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 in creased 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 targeti ng at the most-at-risk  groups and stronger 
eastern cross-border cooperation, resu lting in more cost-effective action. 
The economic downturn could affect HIV/AIDS-re lated aid and threaten prevention  
programmes with potential health budgets cuts. Option 3 would give an incentive for EU MSs 
and neighbouring countries to ma intain 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 cost s on the very few countries 
not already sending sufficient data to ECDC. Fo r 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 le adership and civil society involvement, it should 
improve living conditions for all pe ople affected by the disease.  
 
EN 7   EN 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 indi spensable in fighting HIV/AIDS  
– monitor the scale of the epidemic and co-inf ections, such as tuberc ulosis, hepatitis and 
sexually transmitted infections, at national and cross-border level 
– improve the response to it  
– bring together experts to plan re sponses to future challenges.  
Improved surveillance and monitoring at Eur opean level, mostly by ECDC and other 
specialised and norm-setting bodies, would strength en the basis for effective and sustainable 
public health measures. 
 
EN 8   EN 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 livin g
conditions for people at high risk of HIV and ensure universa l
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 All figures are  approximate estimates 
Budgetary impact for the EU: 
Health Programme 
   
€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   €100M  
reallocation to new 
priorities  
ECDC (surveillance and monitoring)  €4.4M  
  €4.4M  
  €4.4M  
reallocation to new 
priorities  
Budgetary impact for MSs:  
Costs for health an d research budgets 
 
 
Costs of reporting (surveillance)  
n/a 
stable 
 
 
 
no additional 
administrative
burden for 
EU MSs   
n/a 
risk of budget 
cuts, due to 
economic crisis 
 
no additional 
administrative 
burden for EU 
MSs  
n/a 
stable 
reallocation to new 
priorities  
 
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. 
 
EN 9   EN 6. M ONITORING AND EVALUATION  
Achievements could be tracked and mon itoring reports could be published by the 
Commission by 2012. Regular monitori ng encourages all stakeholde rs to share their results 
and achievements promptly. Best practices an d opportunities for cooperation would be more 
accessible to all parties.