1. HTA Benefits and Risks Dr Bernard Merkel European Commission

2. Common Challenges Demographic trends Demographic trends Ageing populations, changing family structures Ageing populations, changing family structures New health technologies New health technologies New products and techniques New products and techniques Higher expectations from citizens Higher expectations from citizens Information explosion Information explosion Health systems under pressure Health systems under pressure Financial sustainability Financial sustainability Quality assurance Quality assurance Developing mechanisms and maintaining them Developing mechanisms and maintaining them

3. What EU can do to help to meet these challenges? Health systems in general Health systems in general EU can provide help to ensure health systems work as well as possible Information Information Benchmarking Benchmarking Sharing best practices Sharing best practices Investment Investment

4. What EU can do to help to meet these challenges? HTA HTA Tool to improve quality and sustainability of health systems Assessing new and emerging technologies help in cost containment Assessing new and emerging technologies help in cost containment Rational priority setting Rational priority setting

5. HTA in the Member States National HTA agencies in the EU National HTA agencies in the EU Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Latvia, Netherlands, Spain, Sweden, and the United Kingdom. Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Latvia, Netherlands, Spain, Sweden, and the United Kingdom. Slovenia planning to establish an agency, action in other MS as well Slovenia planning to establish an agency, action in other MS as well HTA agencies collect, evaluate and produce information and provide it then for policy making HTA agencies collect, evaluate and produce information and provide it then for policy making INAHTA, the international network of HTA agencies is an active network INAHTA, the international network of HTA agencies is an active network

6. What are the possibilities at the EU level? EMEA good example of how EU level assessments can be done. EMEA good example of how EU level assessments can be done. Commission funded various projects to develop methodology and foster networking of HTA bodies Commission funded various projects to develop methodology and foster networking of HTA bodies Sustainable EU network on HTA?

7. What are the benefits and risks of HTA at the EU level? Benefits Avoid duplication Avoid duplication Joint assessments Joint assessments More financial resources More financial resources Guidance for MS in developing HTAs Guidance for MS in developing HTAs Pooling of expertise Pooling of expertise Cross border issues i.e quality Cross border issues i.e quality Link international researchers and policy makers- one contact point Link international researchers and policy makers- one contact point Risks Definition of HTA and methodologies different National settings different i. e social, ethical situations National priorities different i. e who chooses and on what grounds Concerns on reimbursement and pricing issues Issues of involving industry

8. Keeping the balance How to address the risks? How to address the risks? Common definition and framework Common definition and framework Tailor HTA to national settings Tailor HTA to national settings Link between HTA and policy making/guidelines Link between HTA and policy making/guidelines Common methods for creating reports on HTA Common methods for creating reports on HTA Identify needs and prioritising topics for European HTAs or primary research Identify needs and prioritising topics for European HTAs or primary research Define what is HTA and what is not? Pharmaceuticals? Define what is HTA and what is not? Pharmaceuticals? Transparency and quality assurance Transparency and quality assurance

9. What has been done on HTA at the EU level? Several projects since 1994 Several projects since 1994 Communication 2000 Communication 2000 The Decision adopting the public health programme The Decision adopting the public health programme Work Programme 2003 Work Programme 2003 To develop mechanisms for bringing together competent authorities in the EU and applicant countries To develop mechanisms for bringing together competent authorities in the EU and applicant countries Work Programme 2004 Work Programme 2004 Quality assurance in Europe Quality assurance in Europe Work Programme 2005 Work Programme 2005 Quality assurance in Europe Quality assurance in Europe

10. What is currently done on HTA at the EU level? Patient Mobility Process Patient Mobility Process Brought together health ministers and other stakeholders Brought together health ministers and other stakeholders December 2003: Report and nineteen recommendations – including health technology assessment as a key theme December 2003: Report and nineteen recommendations – including health technology assessment as a key theme April 2004: Commission issued response and established High Level Group of Health Services and Medical Care April 2004: Commission issued response and established High Level Group of Health Services and Medical Care

11. HTA in the Patient Mobility Process Commission was invited to consider how a sustainable network and co-ordination function for HTA could be organised and funded Commission was invited to consider how a sustainable network and co-ordination function for HTA could be organised and funded HTA Working Group HTA Working Group The Group to draw conclusions for the Health Council in December The Group to draw conclusions for the Health Council in December Practical work to be taken forward to establish a mechanism to link different projects, organisations and agencies to pool results Practical work to be taken forward to establish a mechanism to link different projects, organisations and agencies to pool results

12. EU Mechanism on Health Technology Assessment The mechanism could have the following functions: Information Information Collaboration Collaboration Knowledge and skills Knowledge and skills Best practices in assessment Best practices in assessment EU level joint assessments EU level joint assessments Disseminating results of HTA Disseminating results of HTA HTA as part of evidence based decision-making HTA as part of evidence based decision-making Assessment of health interventions on health promotion and disease prevention Assessment of health interventions on health promotion and disease prevention

13. Conclusions Member States are facing common challenges to their health systems; HTA is one tool to help them. Member States are facing common challenges to their health systems; HTA is one tool to help them. Benefits from greater cooperation whilst respecting national responsibility for health systems Benefits from greater cooperation whilst respecting national responsibility for health systems A closer and more task-oriented collaboration and systematic exchange of information on HTA to provide reliable, transparent and timely information for policy decisions in the Member States A closer and more task-oriented collaboration and systematic exchange of information on HTA to provide reliable, transparent and timely information for policy decisions in the Member States

14. Further information on Public Health Policy at http://www.europa.eu.int/comm/health/index_en.htm