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Brussels, 26.10.2009 SEC(2009) 1404 final COMMISSION STAFF WORKING DOCUMENT Impact Assessment Accompanying document to the COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS {COM(2009) 569 final} {SEC(2009) 1403} {SEC(2009) 1405} EN
TABLE OF CONTENTS Organisation and Timing.........................................................................................11 Consultation and Expertise .....................................................................................12 HIV/AIDS - characteristics of the disease and epidemiology ............................13 Social and economic burden of HIV/AIDS............................................................19 The first EU action plan 2006-2009.......................................................................20 Funding resources....................................................................................................22 Fundamental Rights and equal treatment in employment and occupation ....23 External policy dimension .......................................................................................23 Political commitments have not been achieved ..................................................25 Data gaps in the centralised EU monitoring and reporting system..................28 Imperfect prevention and treatment activities and potentially diminishing health budgets..........................................................................................................28 Persisting knowledge gaps .....................................................................................30 Worrying trends in several Eastern European countries....................................30 Subsidiarity................................................................................................................32 Necessity Test...........................................................................................................33 Added-Value Test .....................................................................................................33 General objective .....................................................................................................35 EN 3
Option 1: baseline further implementation of current action plan, and evaluation ..................................................................................................................36 Option 2: no EU policy and action plan addressing HIV/AIDS as a single topic 37 Option 3: Current plus a new Commission policy and action plan on combating HIV/AIDS in Europe .............................................................................37 Option 4: discarded options ...................................................................................41 Option 1: Baseline option further implementation of the current action plan 41 Option 2: no EU policy and action plan on HIV/AIDS as a single topic...........43 Option 3: Current plus a new EU policy and action plan on combating HIV/AIDS in Europe .................................................................................................45 EN 4
acquired immunodeficiency syndrome antiretroviral therapy/treatment antiretroviral medicines European Centre for Disease Prevention and Control European Monitoring Centre for Drugs and Drug Addiction European Federation of Pharmaceutical Industries European neighbourhood policy European Union Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) Gilead Sciences, Pharmaceutical company highly active antiretroviral therapy human immunodeficiency virus Impact Assessment Steering Group injecting drug user International Organisation for Migration Millennium Development Goals Member State of the EU men who have sex with men mother-to-child transmission (of HIV) people living with HIV-AIDS Quality Adjusted Life Years The European Surveillance System Joint United Nations Programme on HIV/AIDS United Nations Children's Fund United Nations General Assembly Special Session United Nations Office on Drugs and Crime Voluntary Counselling and Testing for HIV World Health Organization EN 5
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a person's life by his or her potential labour of the way this method assigns value, it may not place as much value on the lost or children. No explicit value is placed on such as pain and suffering associated with illness or deterioration of quality of life. to how much an individual is willing to pay to reduce the probability of illness or death. place on improving their health or preventing further EN 8
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People living with HIV/AIDS (PLWHA) and adult HIV prevalence A view of HIV infection across the EU and neighbouring countries Rates of newly diagnosed cases of HIV per million inhabitants Rates of newly diagnosed cases of HIV per million inhabitants, 2006, with a distribution of transmission modes Poundstone's 3-level determinants of HIV model Examples of HIV/AIDS interventions at national level Dublin Declaration on Partnership to fight HIV/AIDS in Europe and Central Asia Vilnius Declaration on Measures to Strengthen Responses to HIV/AIDS in the European Union and in Neighbouring Countries Bremen Declaration on Responsibility and Partnership Together Against HIV/AIDS Example of Action Plan 2006-2009's unachieved action Estimated coverage of antiretroviral treatment in selected MSs and neighbouring countries. Example of HIV/AIDS problematic in one of the Eastern neighbouring countries Ukraine Action Plan 2006-2009 areas with open actions Comparison of priorities and objectives between Action Plan 2006-2009 and a new Action Plan (Option 3) Possible actions under Option 3 Comparison of options Impacts summary EN 10
P ROCEDURAL I SSUES AND C ONSULTATION OF I NTERESTED P ARTIES Organisation and Timing EN 11
Consultation and Expertise 1 (the Think Tank), the Civil Society Forum 2 (CSF) and the EU 3 (EUHPF). The Think Tank, the CSF and the EUHPF were consulted 4 in a 5 and the EU Health Strategy (2007) 6 also touched upon communicable EN 12
HIV/AIDS - characteristics of the disease and epidemiology A chronic disease without a cure 7 and are therefore at Trends and epidemiology 8 . 9 according to UNAIDS 10 , the number of people living with 11 , 2007 www.euro.who.int , www.ecdc.europa.eu . http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2008/2008_Global_report.asp EN 13
d l t a n u 2 1000 s d u , a 1,6 800 o c e ( t h n 1,2 600 A l e H v a W 0,8 400 L r e p 0,4 200 f P I V r o H 0 0 e b % m k ia d y e ry ly ia a g ta s l ia ia ia n K n ia n s t ia el n va a u st ria iu m lic ar an ce an ec nd Ita tv ni ur al nd nd ga ak ai en U io ria ija ru yp rg ra an no co si ne N lg ub m st on nl an m re ga la La ua bo M la rtu an en Sp ed at ge m en ba la Eg eo Is rd do oc ni kr ai Au Be ep en E Fi Fr er G H un Ire th m rla Po Po om Sl ov ov Sw er Al Ar er Be G Jo ba M ol M or Tu U R D G Li xe he R Sl ed Az Le ch Lu N et F C ze an si R us % HIV prevalence, adult (15-49) Number of PLWHA Figure 2: A view of HIV infection across the EU and neighbouring countries, 2007 Adult (15-49 aged) prevalence (%) Source: UNAIDS EN 14
12 ). Ukraine is 13 . The HIV epidemic 14 http://ecdc.europa.eu/en/Health_topics/Tuberculosis/facts.aspx EN 15
15 , but most of these cases could still be avoided and need to be Root causes driving the epidemic EN 16
risk factors that may influence the and disease progression. pathways by which community and network to society and constitute central structures to understanding the diffusion and EN 17
of HIV/AIDS. 17 . EN 18
Social and economic burden of HIV/AIDS 18 . 19 (a combination of antiretroviral drugs). 20 . EE, the country with the highest number of new infections 21 which shows the delayed cost implications 22 . WTP approach, based on the welfarist EN 19
23 . However, the most affected by The first EU action plan 2006-2009 th and 7 th ) and proposed about 50 different actions in the main EN 20
have been realised in terms of the establishment of networks for treatment, EN 21
Funding resources Health Programmes Research Framework Programmes th , 6 th EU Research Framework Programme (FP) th Research Framework Programme (2007-2013). This priority is closely th FP the Commission has re-structured the European HIV/AIDS research field with a th FP was about 126 million euro (of which 50% on prevention th FP the Commission is pursuing the research priorities started earlier aiming at improving EN 22
Fundamental Rights and equal treatment in employment and occupation 24 , the European Court of Justice (ECJ) held that "sickness cannot as such be External policy dimension EN 23
25 where the HIV/AIDS The ENP applies to the EU's immediate neighbours by land or sea Morocco, Algeria, Tunisia, Egypt, Jordan, Republic of Moldova , Armenia, Georgia, EN 24
P ROBLEM D EFINITION Political commitments have not been achieved 26 , Vilnius 27 (2004) and Bremen 28 ministerial declarations (2007), or the Health Council 29 as well as the UNAIDS 'Three 30 ., endorsed in 2004, for coordination of national responses to HIV/AIDS All EN 25
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31 ", published in 2008 by EN 27
Data gaps in the centralised EU monitoring and reporting system 32 , ES) and Imperfect prevention and treatment activities and potentially diminishing health budgets 33 . The provision of counselling and voluntary testing is, more 34 . But it requires functional infrastructures and access to in particular those from high prevalence regions. In EN 28
36 , many countries in Europe have already adopted different policies or 37 . As shown, among reporting selected MSs 38 in 2007 from 8% to 100% people with HIV 39 . The lowest coverage of ARV treatment, however, is observed in the Estimated ART coverage (% ), 2007 80 60 40 20 0 ia a d y a g s ia n K n iu m ni ce ry nd ni ur nd ia ai en U ne va io lg lg ar to nl an an m an ga la ua an en ed ai do at Es Fi Fr er un Ire th bo rla om ov Sp kr ol er Be Bu G H Li m he R Sl Sw U M xe et F ed Lu N si an R us EN 29
40 . In response to the fiscal and budget threats, governments are more 41 , risking Persisting knowledge gaps fields, such as: Worrying trends in several Eastern European countries EN 30
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T HE R ATIONALE FOR E UROPEAN A CTION 43 . The EU Health Programme 44 continues to provide Subsidiarity (COM(2007)630) , the general objective stipulated in article 152 of the EC EN 32
45 ). We do not yet have a total overview of the cross-border 46 as a Added-Value Test EN 33
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General objective Specific objectives (a) To maintain political leadership and all stakeholders' commitment and involvement and ensure regular monitoring of implementation of targets on HIV/AIDS, as agreed on the political and stakeholders' agenda and stipulated in international agreements (b) To complete HIV/AIDS epidemiological data including monitoring, primary and secondary surveillance and reporting in order to improve the basis for HIV/AIDS policy development and implementation. (c) To encourage and support EU Member States and neighbourhood countries, also in the framework of cross-border cooperation, in designing and implementing effective public health interventions aiming to: reinforce a focus of national HIV/AIDS strategies and activities on populations most at risk (i.e. MSM, IDU, immigrants), with focus on prevention and testing improve the quality of life and living conditions of the vulnerable people, at high risk of HIV infection and ensure universal access to high-quality care and treatment services adapt national HIV/AIDS strategies and activities to non-resolved and/or newly emerging challenges (under-diagnosis, new prevention methods, new treatment options, economic and social burden, etc) with regard to the current economic crisis, ensure that sufficient public and private funding is allocated to HIV/AIDS actions, (d) To address research and knowledge gaps in treatment development, vaccine and microbicide research and development, public health research, behavioural science, socio economic analysis. P OLICY OPTIONS EN 35
Option 1: baseline further implementation of current action plan, and evaluation 47 . This option would allow EN 36
Option 2: no EU policy and action plan addressing HIV/AIDS as a single topic th Research programme would continue as currently planned, but research priorities Option 3: Current plus a new Commission policy and action plan on combating HIV/AIDS in Europe 48 . If this set of indicators would not be and Central Asia. EN 37
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A new EU policy and action plan (Option 3) 2009 (A) Politics/Awareness Cross-border cooperation (Western-Eastern Europe) More focus on: - EU Eastern Europe cooperation and partnership projects /Civil Society Political leadership and stakeholders involvement -address stigma and discrimination more as principal barriers to effective prevention Overall budget reduction - mainstreaming of HIV in EU policies and bi-/ multi lateral agreements => (B) Surveillance Data collection and reporting More focus on: - close outstanding data gaps in the EU and in cross-border dimension Cross-border cooperation Overall budget kept on same level as in previous action plan - behavioural surveillance - timely translation of data into effective policy responses (C) Prevention, New preventive methods strengthen the focus on: treatment, care and support Prevention, treatment and care targeted at most at risk groups - reiterated comprehensive prevention as the approach towards controlling the spread of HIV Promotion of VCT in vulnerable groups - improving quality of life of all people affected by HIV/AIDS and in particular vulnerable groups Overall increased action and budget - UNIVERSAL access to prevention, treatment, care and support - refocus of activities to reach priority groups including undiagnosed (MSM, IDU, immigrants from high prevalence countries) as well as priority regions (D) Research and Funding for research and More focus on: EN 39
future EU Overall budget increase action) - more Public-Private Partnerships for innovations on medicines and vaccines development Weight given as compared to the previous action plan ( more; less; same) EN 40
A NALYSIS OF I MPACT 49 . HIV/AIDS-related actions can be funded under the following three Option 1: Baseline option further implementation of the current action plan EN 41
50 , health national EN 42
Option 2: no EU policy and action plan on HIV/AIDS as a single topic This could e.g. lead the pharmaceutical sector to decrease EN 43
51 , the negative implications of EN 44
Option 3: Current plus a new EU policy and action plan on combating HIV/AIDS in Europe 52 , this concern EN 45
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C OMPARING THE OPTIONS OPTION 1 OPTION 2 OPTION 3 - An action plan would offer a wide range of tools to strategically translate political Commission goals into action. - No additional continuous funding required - HP would continue to support measures to address HIV/AIDS, thus occasional funding would be possible. There may be a risk of money transfer to other health policies. - An action plan would offer a wide range of tools to strategically translate political Commission goals into action. - It provides guidance for EU level action (including research spending and HP activities) - It provides guidance for EU level action (including research spending and HP activities) -Research framework programme (FP7) would probably continue to support HIV/AIDS research. There may be a risk of money transfer to other research priorities. -It provides a political back-up for a partnership among all relevant stakeholders and facilitates the exchange of good practices - The Commission could facilitate a focus on activities around the specific objectives identified above.-It provides a political back-up for a strong partnership among all relevant stakeholders and facilitates the exchange of good practices -Transparency and specificity of the EU goals and targets leading to implementation of set actions for HIV/AIDS related problems. - No potential administrative costs caused in MSs. - A certain degree of continuity could be provided but only at technical level. -Transparency and specificity of the EU goals and targets leading to implementation of set actions for HIV/AIDS related problems, including new trends and challenges. - The evaluation of the activities implementing the current action plan would allow for assessing how far EU and national investments, both financial and political, have had an impact on the epidemic. - The evaluation of the activities implementing the new action plan would allow for assessing how far EU and national investments, both financial and political, have had an impact on the epidemic. -EU surveillance and monitoring system would be enhanced and improved however to a limited extent. - EU surveillance and monitoring system would be enhanced and improved - Research and knowledge gaps could be partially overcome - Research and knowledge gaps would be overcome. EN 48
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-No new incentive - The EU sends a negative political sign of complacency, lost political opportunity to recall importance of prevention policies for HIV in times of budgetary constraints - Potential budgetary implications for MSs (e.g. increased access to ARV would increase costs for national health budgets) - Loss of political momentum to present a future oriented action plan based on current evidence, data and needs, lost political opportunity to recall importance of prevention policies for HIV in times of budgetary constraints. - Potential additional reporting duties of MSs for surveillance and monitoring (e.g. cross-border movement and migration) resulting in additional administrative burden - Long term costs related to reduced push for prevention. Potential budgetary implications for MSs (e.g. increased access to ARV would increase costs for national health budgets) - Potential budgetary implications for MSs (e.g. increased access to ARV would increase costs for national health budgets) - No framework for action/guidance would be provided to correlate thematic priorities to available budget. - EU surveillance and monitoring system would continue in its present shape, and would remain incomplete. - No guidance for EU level action (including research spending and HP activities) - Expectations as expressed by MSs or the civil society would not be met, commitments would not be realised. - The EU would no longer contribute to a political coordination of activities in the field of HIV/AIDS, and could not defend the rights of PLWHA in a particular manner. - Civil society would lose much support across Europe, in particular in countries where civil society is traditionally not very strong. - EU surveillance and monitoring system would continue in its present shape, and would remain incomplete. EN 49
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Option 1 Option 2 Option 3 + - ++ + + ++ + - ++ + - ++ + - ++ + - ++ + + ++ estimation estimation estimation Health Programme approx. 20M approx. 20M euros or less, approx. 20M euros euros reallocation to reallocation of priorities defined HIV funding to in new action plan other policies covered by the HP Research Framework Programme approx. 100M approx. 100M approx. 100M euros euros or less euros reallocation of reallocation to HIV funding to priorities defined other policies in new action plan covered by the HP ECDC (surveillance and monitoring) approx. 4.4M approx. 4.4M approx. 4.4M euros euros euros reallocation to priorities defined in new action plan EN 51
Costs for health budgets (prevention, treatment...) and research n/a n/a n/a stable risk of budget stable cuts, due to reallocation to economic crisis priorities defined in new action plan no additional no additional administrative Costs of reporting (surveillance) administrative administrative burden for EU costs stemming burden for from new data EU MSs MSs reporting requirements M ONITORING AND E VALUATION EN 52
OF ANNEXES strategy in place or under preparation. implementation of the HIV/AIDS Action Plan 2006-2009. EN 53
