Health technology assessment and health policy-making in Europe: current status, challenges and potential

Marcial Velasco Garrido Finn Børlum Kristensen Camilla Palmhøj Nielsen

Reinhard Busse

Observatory Studies Series No 14

on Health Systems and Policies

European

HEALTH TECHNOLOGY ASSESSMENT AND HEALTH POLICY-MAKING IN EUROPE

Current status, challenges and potential

Health Technology Assessment and Health Policy-Making in Europe

The European Observatory on Health Systems and Policies supports and promotes evidence- based health policy-making through comprehensive and rigorous analysis of health systems in Europe. It brings together a wide range of policy-makers, academics and practitioners to analyse trends in health reform, drawing on experience from across Europe to illuminate policy issues.

The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the Open Society Institute, the World Bank, the London School of Economics and Political Science and the London School of Hygiene & Tropical Medicine.

Health Technology Assessment and Health Policy-Making in Europe Current status, challenges and potential

Marcial Velasco Garrido, Finn Børlum Kristensen, Camilla Palmhøj Nielsen, Reinhard Busse

The European Observatory on Health Systems and Policies supports and promotes evidence- based health policy-making through comprehensive and rigorous analysis of health systems in Europe. It brings together a wide range of policy-makers, academics and practitioners to analyse trends in health reform, drawing on experience from across Europe to illuminate policy issues.

The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the Open Society Institute, the World Bank, the London School of Economics and Political Science and the London School of Hygiene & Tropical Medicine.

Keywords: TECHNOLOGY ASSESSMENT, BIOMEDICAL OUTCOME ASSESSMENT (HEALTH CARE) POLICY MAKING HEALTH POLICY DELIVERY OF HEALTH CARE EUROPE

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List of tables, figures and boxes vii

Acknowledgements xi

About the authors xiii

Introduction 1 Marcial Velasco Garrido, Finn Børlum Kristensen, Camilla Palmhøj Nielsen, Reinhard Busse

Chapter 1. Transnational collaboration on health technology 5 assessment – a political priority in Europe Finn Børlum Kristensen for the EUnetHTA partners

Chapter 2. Policy processes and health technology assessment 19 Camilla Palmhøj Nielsen, Antonio Sarriá Santamera, Hindrik Vondeling

Chapter 3. What is health technology assessment? 31 Finn Børlum Kristensen, Camilla Palmhøj Nielsen, Debbie Chase, Kristian Lampe, Sun Hae Lee-Robin, Marjukka Mäkelä

Chapter 4. Health systems, health policy and health technology assessment 53 Marcial Velasco Garrido, Annette Zentner, Reinhard Busse

Chapter 5. Health technology assessment in Europe – overview 79 of the producers Marcial Velasco Garrido, Juan Antonio Blasco Amaro, Americo Cichietti, Davide Integlia, Inger Natvig Norderhaug, Beatriz Valentin, Annette Zentner

Contents

vi Health Technology Assessment and Health Policy-Making in Europe

Chapter 6. What are the effects of HTA reports on the health system? 109 Evidence from the research literature Ansgar Gerhardus, Evelyn Dorendorf, John-Arne Røttingen, Antonio Sarriá Santamera

Chapter 7. Needs and demands of policy-makers 137 Gerardo Atienza Merino, Leonor Varela Lema

Chapter 8. Future challenges for HTA in Europe 161 John-Arne Røttingen, Ansgar Gerhardus, Marcial Velasco Garrido

Tables

Table 2.1 Policy and research communities: different notions 25 of knowledge

Table 3.1 How issues defined in the model may be translated into 44 research questions

Table 4.1 Decisions related to health technologies 66

Table 4.2 Appraisal committees and corresponding assessment 70 units (selected examples)

Table 4.3 Assessment, appraisal and decision-making institutions 72 in Switzerland

Table 4.4 Criteria guiding coverage (funding + reimbursement + investing 74 + planning) decisions in selected European countries

Table 5.1 HTA agencies and units in Europe 90

Table 5.2 Overview of institutions performing HTA and their activities in 94 selected European countries

Table 6.1 Included studies – impact 126

Table 7.1 Included studies – needs and demands 156

Table 8.1 A quality framework for HTA 169

Table 8.2 Qualities of the HTA community and the Cochrane 177 Collaboration: a comparison

List of tables, figures and boxes

Figures

Fig. 2.1 Simple ideal model of a policy process 21

Fig. 2.2 Factors that influence policy-making 24

Fig. 3.1 From policy questions to HTA reports that inform policy 33

Fig. 3.2 HTA process 39

Fig. 4.1 Relationship between types of decisions and the definition 67 of benefit basket

Fig. 4.2 General model of coverage decisions 69

Fig. 6.1 Hierarchical steps of the impact of HTA reports 111

Fig. 7.1 Decision-making process 139

Fig. 7.2 Selection of studies for systematic review 143

Fig. 8.1 Knowledge value chain in the health sector 162

Fig. 8.2 Different levels of health-care technologies/interventions 164

Fig. 8.3 Not too early, not too late: effective implementation 173 of innovations

Fig. 8.4 Staircase of collaboration 174

Fig. 8.5 Role of HTA in the health system: a Norwegian example 179

Boxes

Box 1.1 Cox Report: key statements on HTA 8

Box 1.2 Key messages in the WHO Health Evidence Network (HEN) 9 policy brief

Box 1.3 Tallinn Charter: paragraph on innovations and HTA 10

Box 1.4 Article 17 of the Proposal for a Directive of the European 10 Parliament and of the Council on the application of patients’ rights in cross-border healthcare (presented by the Commission)

Box 1.5 Explanatory memorandum of the Proposal for a Directive 11 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare

Box 1.6 Excerpt from: A Community framework on the application 12 of patients’ rights in cross-border healthcare which accompanied the Directive proposal

Box 4.1 Areas of health technologies 56

Health Technology Assessment and Health Policy-Making in Europeviii

ixList of tables, figures and boxes

Box 4.2 Technologies in the health system: the example of 57 cardiovascular disease

Box 4.3 Types of evidence in health-care system decisions 62

Box 4.4 Assessment and appraisal in Germany 71

Box 4.5 Coverage and pricing in France 71

Box 5.1 Establishment of the SBU 82

Box 5.2 HTA without an HTA agency: the Italian network 84

Box 5.3 Elucidating target audience’s perspective to determine 86 fields of work for an HTA agency

Box 5.4 NCCHTA – research to inform NHS decision-making 91

Box 5.5 Belgian Health Care Knowledge Centre: HTA and 93 health services research

Box 5.6 Expanding mandate of HTA institutions: the NOKC 96

Box 5.7 Hospital-based HTA: technology assessment unit in 100 the Agostino Gemelli University Hospital

Box 5.8 Assessments for pharmaceutical reimbursement 102 policies – examples from Europe

Box 6.1 Systematic review: method 113

Box 6.2 Impact of HTA reports on policy and practice: results 116 from a nine-country project

Box 7.1 Knowledge-transfer strategy 140

Box 7.2 Methodology of systematic review 142

Box 7.3 Facilitators of the use of research evidence in policy-making 148

Box 7.4 Barriers to the use of research evidence in policy-making 149

Acknowledgements

This book was made possible by cooperation between the European Network for Health Technology Assessment (EUnetHTA) Project and the European Observatory on Health Systems and Policies. The EUnetHTA Project ran from 2006 to 2008 and was supported by a grant from the European Commission. Sole responsibility for the content of this publication lies with the authors and the European Commission is not responsible for any use that may be made of the information contained therein.

The Technische Universität Berlin hosted a workshop in March 2007. This brought together the chapter authors and a group of selected European decision-makers and HTA experts to discuss preliminary drafts of the book. We thank all participants for the valuable discussions and insights obtained during the workshop: Robert van den Oever, Ri de Ridder (Belgium); Henrik Hauschildt Juhl (Denmark); Triin Habicht, Margus Lember (Estonia); Liisa- Maria Voipio-Pulkki (Finland); Bernhard Gibis, Rainer Hess (Germany); Mairin Ryan (Ireland); Roberto Grilli, Guiseppe Murolo, Lucia Turco (Italy); Audun Haga (Norway); Eva Turk (Slovenia); Peter Indra, Maya Züllig (Switzerland); Ken Stein (UK); Jan Bultmann (World Bank). We also especially thank Patricia Meirelles, Monika Knaden, Julia Weller and Miriam Blümel from the Technische Universtität Berlin for their technical support in the organization of the workshop as well as the European Observatory for co-funding this meeting.

Many other people from institutions participating in the EUnetHTA Project contributed valuable information for writing some parts of this book, especially Chapters 5 and 6. For their helpful information we would like to thank: Neil Adams, Cecile Camberlin, Irina Cleemput, Anne-Florence Fay, Marjukka Mäkelä, Kersti Meiesaar, Mário Miguel Rosa, Berit Mørland, Mairin Ryan, Pedro Serrano, Eva Turk and Ulla Væggemose.

We would also like to express our gratitude to those who reviewed earlier drafts of some chapters and provided valuable comments to the authors: Karen Facey, Bernhard Gibis, Egon Jonsson, Devidas Menon and Ken Stein.

xii Health Technology Assessment and Health Policy-Making in Europe

We are especially grateful to the publishing team at the European Observatory for their support, patience and excellent work: Cecile Knai, Jonathan North, Caroline White and Jo Woodhead (copy-editing).

About the authors

Gerardo Atienza Merino is Researcher at the Galician Agency for Health Technology Assessment (AVALIA-T), Santiago de Compostela, Spain.

Juan Antonio Blasco Amaro is Director of the Health Technology Assessment Unit of the Autonomous Community of Madrid (UETS), Madrid, Spain.

Reinhard Busse is Professor of Health Care Management at the University of Technology Berlin and Associate Head for Research Policy of the European Observatory on Health Systems and Policies, Berlin, Germany.

Debbie Chase is Researcher in the National Coordinating Centre for Health Technology Assessment (NCCHTA), Southampton, United Kingdom.

Americo Cicchetti is Professor of Health Economics and Health Care Management in the Catholic University of Sacred Heart, Rome, Italy.

Evelyn Dorendorf is Researcher at the Department of Epidemiology and International Public Health of the University of Bielefeld, Germany.

Ansgar Gerhardus is Lecturer of Health Technology Assessment and Evidence Based Public Health at the Department of Epidemiology and International Public Health of the University of Bielefeld, Germany.

Davide Integlia is Researcher at the Catholic University of Sacred Heart, Rome, Italy.

Finn Børlum Kristensen is Director of the Danish Centre for Health Technology Assessment (DACEHTA) and Project Leader of the EUnetHTA Project.

Kristian Lampe is Senior Medical Officer in the Finnish Office for Health Technology Assessment (FinOHTA), Helsinki, Finland.

Marjukka Mäkelä is Director of the Finnish Office for Health Technology Assessment (FinOHTA), Helsinki, Finland.

Camilla Palmhøj Nielsen is Specialised Advisor at the Danish Centre for Health Technology Assessment (DACEHTA), Copenhagen, Denmark.

Inger Natvig Norderhaug is Researcher in the Norwegian Knowledge Centre for Health Services (NOKC), Oslo, Norway.

Sun Hae Lee-Robin is Head of the Medical and Surgical Procedures Assessment Department at the French National Authority for Health (HAS), Saint-Denis La Plaine, France.

John-Arne Røttingen is Chief Executive of the Norwegian Knowledge Centre for Health Services (NOKC), Oslo, Norway.

Antonio Sarriá Santamera is Director of the Agency of Health Technology Assessment (AETS) at the Institute of Health Carlos III, Madrid, Spain.

Beatriz Valentin is Associate Researcher in the Health Technology Assessment Unit of the Autonomous Community of Madrid (UETS), Madrid, Spain.

Leonor Varela Lema is Associate Researcher at the Galician Agency for Health Technology Assessment (AVALIA-T), Santiago de Compostela, Spain.

Marcial Velasco Garrido is Researcher at the Department for Health Care Management at the University of Technology, Berlin, Germany.

Hindrik Vondeling is Associate Professor at the Center for Applied Health Services Research and Technology Assessment (CAST), and at the Research Unit for Health Economics, University of Southern Denmark, Odense, Denmark.

Annette Zentner is Researcher at the Department for Health Care Management at the University of Technology, Berlin, Germany.

Health Technology Assessment and Health Policy-Making in Europexiv

Introduction Marcial Velasco Garrido, Finn Børlum Kristensen, Camilla Palmhøj Nielsen,

Reinhard Busse

Thanks to research and innovation, new technologies with the potential to improve the health of populations through more effective care are continuously being introduced. Indeed, health care stands to benefit from the constant developments and technological innovations in the life and health sciences in general, and in medical science in particular. However, not every technological development results in net health gains. The history of medicine and health counts many examples of technologies which did not produce the expected benefits or even proved to be harmful. However, technologies of proven effectiveness – i.e. those associated with relevant health improvements – create a continuous challenge for health systems since their application may require additional (and not only financial) resources or existing (finite) resources to be redistributed within the health system. Health technologies pose similar challenges to health-care systems throughout the world. Thus, it is necessary to ensure that health technologies are evaluated properly and applied to health care efficaciously. In order to optimize care using the available resources, the most effective technologies should be promoted while taking consideration of organizational, societal and ethical issues.

Health technology assessment (HTA) aims to inform health policy and decision- making processes concerning health technologies precisely on these issues. HTA has a strong foundation in research on the health effects and broader implications of the use of technology in health care. Its potential for contributing to safer and more effective health care is widely acknowledged in Europe and interest in this field has been growing steadily. Since the establishment of the first national HTA agency in Sweden in the 1980s, the number of institutions involved in the assessment of health technologies has multiplied in Europe. Most European Member States have established a formal HTA programme or are considering the feasibility of establishing HTA intelligence to inform health policy-making.

Since its inception, the HTA community has acknowledged the need for international collaboration and networking. Interest in collaboration among

2 Health Technology Assessment and Health Policy-Making in Europe

European HTA actors has been the impetus for a series of projects supported by the European Union. The EUR-ASSESS Project (1994-1997) contributed to the establishment of a common and consistent understanding of HTA and also identified the need for information sharing among European countries (Banta et al. 1997). The European Collaboration for Health Technology Assessment/ European Collaboration for Health Interventions (ECHTA/ECAHI) Project (2000-2002) built upon EUR-ASSESS’s groundwork. It concluded that there was a need to create a sustainable network for HTA within the European Union involving those working actively on assessments in health care in Europe, focusing on those in the public sector but welcoming those working in other settings (Jonsson et al. 2002). The European Network for HTA (EUnetHTA) Project builds on these previous projects and connects public HTA agencies and academic institutions as well as ministries of health and international organizations.

This book has been produced as a collaboration between the EUnetHTA Project and the European Observatory on Health Systems and Policies with the aim of reviewing the relationship between HTA and policy-making from different perspectives, with a special focus on Europe. The purpose of this cooperation is to transmit the value of HTA to a wide public in decision-making and health- care management in order to increase their awareness of HTA activities and evidence-based decision-making.

In Chapter 1 the authors describe how transnational HTA collaboration has moved up the European health policy agenda to become a political priority and how EUnetHTA is facing the challenge of establishing a permanent collaboration that is useful for policy-making.

Chapter 2 provides an outline of the generalities of policy processes and includes a discussion of the potential role of HTA from a political science perspective.

In Chapter 3, HTA is defined as a process with an emphasis on its role in providing evidence-based information to policy processes. The chapter provides a common understanding of the field and an overview of the methodological developments since the 1990s, emphasizing the contributions of the EUnetHTA Project. Starting from a broad understanding of the concept of health technologies and HTA, Chapter 4 contains an overview of the types of decisions in which HTA can provide inputs to policy-making in the health system.

Chapter 5 gives an overview on the institutions performing HTA in Europe. The aim is not to present a collection of country by country studies but to depict the variety of institutional arrangements and the tendencies shared in the European context. In Chapter 6 the authors address the question of

3Introduction

whether HTA has an impact on decision-making and provide a framework to analyse the effects of HTA in the health system and a summary of the empirical evidence.

Decision-makers’ perspective of HTA is introduced in Chapter 7 in which the barriers and facilitators for transferring research knowledge into policy-making are identified. Above and beyond the information provided by their contents, good illustrations of the power of systematic reviews (a methodological tool commonly used in HTA) to organize knowledge in a particular field and uncover areas that require further research are presented in Chapters 6 and 7.

Finally, the authors of Chapter 8 draw on previous chapters and on the discussions held at a workshop in Berlin in March 2007 which gathered HTA actors and potential users (i.e. policy-makers) from several European countries to present a discussion of the future challenges for HTA.

References Banta HD et al. eds. (1997). Introduction to the EUR-ASSESS Project. International Journal of Technology Assessment in Health Care, 13:133–143.

Jonsson E et al. eds. (2002). European collaboration for health technology assessment in Europe. International Journal of Technology Assessment in Health Care, 18:218–237.

Chapter 1

Transnational collaboration on health technology assessment

– a political priority in Europe

Finn Børlum Kristensen for the EUnetHTA partners

Introduction

Health-care provision is increasingly subject to policy decisions and is managed more than ever before. Health care is also becoming more international and collaboration is increasing as the health professions, research and industry all work across borders. Differing health-care systems across the countries of Europe result from national and regional history and policy developments and priorities. Despite these differences, common interests and policies (e.g. in professional training, health information and health systems) that impact on national health-care practice are being explored and developed at the European Union (EU) and wider European level (e.g. by WHO).

As described later in this chapter, health technology assessment (HTA) is a significant example of a field of common interest. All interventions and procedures in health care are basically technologies – including surgery and pharmaceuticals. HTA is a systematic, broad-ranging evaluation of the implications of using technologies within a particular health-care system (see Chapter 3). It aims to provide structured, evidence-based input to policy- making in order to inform the formulation of safe and effective health policies that are patient-focused and seek to achieve best value. Despite its policy

6 Health Technology Assessment and Health Policy-Making in Europe

goals, HTA must always be rooted firmly in research and the scientific method (Kristensen, 2006).

In order to be most relevant, HTA in Europe must be undertaken within the policy context of a particular country (rather than at European level) taking account of national priorities and systems, including regionalization. The principle of subsidiarity is paramount, and must be observed, but collaboration among European countries can support and improve national HTA processes (EUnetHTA, 2008).

This chapter briefly introduces HTA and the EUnetHTA Project; illustrates some important challenges in the relationship between HTA and current international and European policy developments; and describes how a permanent collaboration on HTA in Europe is intended to meet these challenges.

Policy background for increased collaboration in HTA in Europe

European health initiatives and HTA

Where EUnetHTA has been active, decision-makers and policy-makers have shown significantly more interest in the widespread use of HTA to inform policy over the last few years. The prospect of increased transnational collaboration has emerged following more widespread experience with the use of HTA in health-care planning and management in several countries. This process has been promoted by international HTA organizations and by the European Commission (see Chapter 3).

HTA’s potential as a tool for decision-making in policy decisions on health interventions and technologies has attracted interest in many parts of the world and in international governmental organizations such as WHO, the Organisation for Economic Co-operation and Development (OECD) and the World Bank. At the global level, in its 120th session (22–29 January 2007), the WHO Executive Board forwarded a suggestion to the World Health Assembly to urge Member States to collect, verify, update and exchange information on health technologies as an aid to their prioritization of needs and allocation of resources (WHO, 2007).

The European Commission and EU Member States express support for the development of a sustainable collaboration and organizations for HTA at Member State level. Within the EU, HTA is now recognized as an essential element for improving the quality of health care in the different health systems. This is in line with the common values and principles that underpin all health- care systems in Europe (Official Journal of the European Union, 2006).

7Transnational collaboration on health technology assessment – a political priority in Europe

The overarching values of universality, access to good quality care, equity and solidarity have been widely accepted in the work of the different institutions and constitute a set of values that are shared across Europe. Universality means that no one is barred access to health care; solidarity is closely linked to the financial arrangement of national health systems and the need to ensure accessibility for all; equity relates to equal access according to need, regardless of ethnicity, gender, age, social status or ability to pay. EU health systems also aim to reduce the gap in health inequalities – a concern of EU Member States. This is closely linked to work on promoting healthy lifestyles in order to prevent illness and disease.

At the Informal Health Council in Aachen, Germany (19–20 April 2007) the Trio Presidency of the EU (German, Portuguese and Slovenian Presidencies, January 2007–June 2008) provided a document called Health care across Europe: striving for added value. This referred to values and policies by noting:

In line with the value of access to good quality care and the principle of patient safety, we can improve the health-care quality standards across the different health systems in the EU through the following: evidence-based medicine, health technology assessments, cost-benefit-analyses (Notes of the Trio Presidency, 2007).

The efforts for establishing a permanent network are also in line with the Programme of Community action in the field of health and consumer protection (2008-13) which states:

In order to ensure a high level of coordination between action and initiatives taken by the Community and Member States in the implementation of the Programme, it is necessary to promote cooperation between Member States and to enhance the effectiveness of existing and future networks in the field of public health. The participation of national, regional and local authorities at the appropriate level in accordance with the national systems should be taken into account in regards to the implementation of the Programme (European Commission, 2007).

Policy documents to improve stakeholder knowledge on the potential of HTA

Recently, several publications have addressed the potential of HTA as an independent, analytical approach for informing health-care policy. Financing sustainable healthcare in Europe: new approaches for new outcomes (known as the Cox Report) is an international study that was endorsed and presented to the

8 Health Technology Assessment and Health Policy-Making in Europe

European Commission in February 2007 (Sorenson, Kanavos & Drummond, 2007). Its key statements on HTA are presented in Box 1.1.14

The WHO Regional Office for Europe published a policy brief on HTA in June 2008 (Sorenson C et al. 2008). The key messages are presented in Box 1.2.

Articulate political commitment to implement HTA in health-care policy in Europe

At the WHO European Ministerial Conference on Health Systems in June 2008, health ministers of 53 countries adopted The Tallinn Charter: Health Systems for Health and Wealth (WHO, 2008). This identifies HTA as an important means of creating resources for health-care systems (see Box 1.3).

In July 2008 the European Commission adopted a draft Directive to facilitate the application of European patients’ rights in relation to cross-border health care (European Commission, 2008a). HTA (see Box 1.4) is indicated to be one of the Directive’s major provisions and identified as a: “clear area of European added-value. This initiative will help to reduce overlap and duplication of efforts in this field and hence promote the effective and efficient use of resources.” The explanatory memorandum which opens the Directive proposal explains the intentions for a European HTA network (see Box 1.5).

The draft Directive was accompanied by a Communication on improving cooperation between Member States. A Community framework on the application of patients’ rights in cross-border healthcare also underscores that HTA is a field in which collaboration between Member States can yield relevant added value. 1 Based on an initiative launched at a conference in 2005 at the European Investment Bank in Luxembourg and the endorsement of Luxembourg’s Ministry of Health and the Finnish Innovation Fund (Sitra). Four reports were written and delivered as one policy document in 2007 – the Cox Report (http://www.sustainhealthcare.org/cox.php). The initiative has received continuing support from the project’s founding partner and sponsor since 2005 – Pfizer Inc.

Box 1.1 Cox Report: key statements on HTA

HTA can play a valuable role in health-care decision-making but the process •

must be transparent, timely, relevant, in-depth and usable.

Assessments need to use robust methods and be supplemented by other •

important criteria.

By maximizing the potential of HTA, decision-makers will be better able to •

implement decisions that capture the benefits of new technologies, overcome

uncertainties and recognize the value of innovation, all within the constraints of

overall health system resources.

Source: Sorenson, Kanavos & Drummond, 2007

9Transnational collaboration on health technology assessment – a political priority in Europe

Policy issues

HTA is an important tool for informing effective regulation of the diffusion and use of • health technologies.

Key policy issues surrounding the use of HTA fall into three areas: (i) bodies, • decision-makers and other stakeholders involved; (ii) methods and processes

employed; and (iii) how HTA findings are implemented.

The impact of HTA can be enhanced if key stakeholders (e.g. patients, providers, • industry) are adequately involved; decision-makers give advance commitments to

use assessment reports (and assessments meet their needs); necessary resources

are available for implementing decisions; there is transparency in the assessment

and decision-making processes; and collaboration, knowledge and skills are

transferred across jurisdictions.

Policy measures

Increased stakeholder involvement throughout the process can help to capture and • improve the real-world value and applicability of HTAs. Nevertheless stakeholder

involvement needs to be transparent and well-managed in order to ensure that the

objectivity of assessments is not compromised.

HTAs must be timely in relation to the decisions they seek to inform. Simpler • studies, early-warning systems and conditional approvals are increasingly being

used as mechanisms for managing the uncertainty surrounding new and emerging

technologies while facilitating the timeliness and relevancy of HTA.

International collaboration amongst HTA bodies can facilitate the development of • methods and more efficient assessment processes; and facilitate knowledge transfer

and capacity-building of less established HTA systems and programmes.

To facilitate the use and implementation of HTA reports in decision-making, • incentives within a given health-care system are appropriately aligned with decisions

based on (or informed by) HTA.

Implementation considerations

Problems with applying technical information and national recommendations to • local decision-making can be reduced if there are formal linkages between the

producers and users of HTA.

Learning through collaboration and exchange of experience can help to overcome • those institutional and capacity barriers that often hinder implementation.

Box 1.2 Key messages in the WHO Health Evidence Network (HEN) policy brief

Source: Sorenson C et al. 2008

10 Health Technology Assessment and Health Policy-Making in Europe

It explicitly refers to the EUnetHTA Project as a basis for a clear framework that can be established under the Directive to take forward these activities on the basis of the results of this pilot (see Box 1.6) (European Commission, 2008b).

The proposed Directive will now undergo a legislative process with the Council of Ministers and the Parliament. It will be implemented through comitology, defined on the Europa web site as:

… forums for discussion consist of representatives from Member States and are chaired by the Commission. They enable the Commission to establish dialogue with national administrations before adopting implementing measures. The Commission ensures that measures reflect as far as possible the situation in each of the countries concerned.

Fostering health policy and systems research and making ethical and effective use of

innovations in medical technology and pharmaceuticals are relevant for all countries;

health technology assessment should be used to support more informed decision-

making.

Box 1.3 Tallinn Charter: paragraph on innovations and HTA

Source: WHO, 2008

Box 1.4 Article 17 of the Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (presented by the Commission)

Cooperation on management of new health technologies

1. Member States shall facilitate development and functioning of a network connecting

the national authorities or bodies responsible for health technology assessment.

2. The objective of the health technology assessment network shall be:

(a) to support cooperation between national authorities or bodies;

(b) to support provision of objective, reliable, timely, transparent and transferable

information on the short- and long-term effectiveness of health technologies and

enable an effective exchange of this information between national authorities or

bodies.

3. Member States shall designate the authorities or bodies participating in the network

as referred to in paragraph 1 and communicate to the Commission names and

contact details of those authorities or bodies.

4. The Commission shall, in accordance with the procedure referred to in Article 19(2),

adopt the necessary measures for the establishment and the management of this

network and specify the nature and type of the information to be exchanged.

11Transnational collaboration on health technology assessment – a political priority in Europe

EUnetHTA Project and EUnetHTA Collaboration

EUnetHTA Project

In 2004, EU Member States in the High Level Group on health services and medical care requested the establishment of a sustainable network for HTA in Europe. This was endorsed by the Council of Health Ministers and the European Commission. Following a call for proposals, the EUnetHTA Project was established in 2006 and co-funded for three years by the European Commission. It established an effective European network to connect public HTA agencies, research institutions and health ministries; enable effective exchange of information; and support policy decisions on the use of health technologies in Member States at national or regional levels. A total of 63 HTA institutions and organizations joined the EUnetHTA Project, organized as an open network with extensive communication facilities.

The EUnetHTA Project was built on previous European collaborative projects supported by the EU (Banta et al. 1997; Banta and Oortwijn, 2000; Jonsson et al. 2002) and on the OECD Project on Health Technologies (OECD, 2005).

Box 1.5 Explanatory memorandum of the Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross- border healthcare

… this Directive provides for establishment of the Community network on health

technology assessment (Article 17), which should support cooperation between

responsible national authorities, support provision of objective, reliable, timely,

transparent and transferable information on the short- and long-term effectiveness of

health technologies, enable an effective exchange of this information within the network

and provide support to policy decisions by Member States.

Currently there are wide variations and frequent duplication in such assessments

between and within Member States in terms of the methodologies used and the

consequent uptake of innovations, which act as a barrier to the free movement of

the technologies concerned and (through the consequent variations in health care)

undermine confidence in standards of safety and quality across the Union.

Collaborating on providing common criteria with a view to establish such an evidence

base at Community level will help to spread best practice, avoid duplication of

resources and develop common core information packages and techniques that can

then be used by Member States, to help them make best use of new technologies,

therapies and techniques and … will also help realise the potential of the internal market

in this area by maximising the speed and scale of diffusion of innovations in medical

science and health technologies.

12 Health Technology Assessment and Health Policy-Making in Europe

The EUnetHTA partners developed practical tools to share methodological frameworks and scientific evidence for HTA (see e.g. Chapter 3). These tools facilitate information sharing across national or regional systems when health technologies are assessed for new or continued use in health-care systems. This cross-border collaboration on HTA can be used to reduce duplication of effort and save time and resources within individual countries.

Box 1.6 Excerpt from: A Community framework on the application of patients’ rights in cross-border healthcare which accompanied the Directive proposal

– European cooperation on health care: the directive establishes a framework for

European cooperation in areas such as: European reference networks, health

technology assessment, data collection and quality and safety, in order to enable the

potential contribution of such cooperation to be put effectively in practice and on a

sustained basis.

2.3 Future practical European cooperation on health care

There are situations where European cooperation can add value to the actions of the

Member States because of the scale or nature of the health care concerned. The

framework established by the Directive will help to realise the potential of this European

added-value. It makes provision for developing future practical cooperation at European

level in three areas in particular.

2.3.2 Health Technology Assessment

Constant innovations in medical science and health technologies bring benefits

in better health care. However, they also create a continuing challenge for health

systems to ensure that they are properly evaluated and used in the most cost-effective

manner possible. Health technology assessment (HTA) is a multidisciplinary process

that summarises information about the medical, social, economic and ethical issues

related to the use of a health technology, in order to ensure this. This is a clear area

of European added-value, where cooperation at Community level can help to reduce

overlap and duplication of efforts and hence promote the effective and efficient use of

resources.

The Commission is supporting a pilot European network on health technology

assessment called “EUnetHTA”. The overall aim of EUnetHTA is to establish an effective

and sustainable European network for health technology assessment that informs

policy decisions. EUnetHTA connects public HTA agencies, research institutions and

health ministries to enable effective exchange of information and support to policy

decisions by the Member States. The EUnetHTA Project is being co-financed by the

European Commission and contributions from network members. As with European

reference networks, a clear framework for taking forward these activities can be

established under the Directive on the basis of the results of this pilot.

13Transnational collaboration on health technology assessment – a political priority in Europe

The EUnetHTA Project worked as a network on specific tasks focused on creating practical tools to produce HTAs and for local adaptation of existing HTAs. It also generated information and models to monitor new technologies and inform decision-makers on emerging technologies. This practically driven collaborative work raised interest among the institutions, professionals and researchers involved in producing HTAs and among stakeholders at the policy level because of its innovative tools and high level of communication and collaboration.

International HTA organizations have shown interest in EUnetHTA. Its partners have already developed new methods and produced information that can be shared among those involved in producing HTA information and reports. Thus the project has been at the forefront of methodological developments.

From project to permanent collaboration

The European Commission co-funded the EUnetHTA Project from 2006 to 2008. Building on their positive interaction the EUnetHTA partners decided to create a sustainable, permanent European HTA collaboration in order to ensure continuation of communication, collaboration networks and activities (EUnetHTA, 2008). This will involve HTA agencies and others involved in the production of HTA information, with support from European governments, the European Commission and international health organizations.

One key challenge for the EUnetHTA Project was to convince governments and the EU that investing in EUnetHTA is cost effective and provides important benefits through better health-care decisions. As described in this chapter, the European Commission is now taking concrete steps to ensure the sustainability of EUnetHTA.

By focusing on collaboration on HTA in Europe, the EUnetHTA Collaboration sets out to:

help reduce unnecessary duplication of HTA activities•

develop and promote good practice in HTA methods and processes•

share what can be shared•

facilitate local adaptation of HTA information.•

The EUnetHTA Collaboration intends not only to coordinate work more effectively but also, when feasible, to divide the work on specific technology assessments in a methodologically sound and transparent way. The volume of

14 Health Technology Assessment and Health Policy-Making in Europe

high quality HTA input to policy and decision-making must be multiplied from this tight network.

The collaboration aims to fulfil the following main functions:

act as a contact point to provide a gateway to the HTA community in Europe;•

be the European HTA information and communication system;•

develop and improve common processes for performing and reporting HTA;•

provide information on emerging/new technologies and facilitate generation • of new evidence;

facilitate the establishment and continuous development of HTA institutions; •

pilot processes for the production of HTA core information.•

The organization will establish standing committees to oversee its functions and working groups to take forward specific projects or tasks. A plenary assembly of member organizations will take a strategic overview of the work of the EUnetHTA Collaboration. An elected subgroup will serve as a management board for a fixed term and a forum will be established. This will have broad and balanced stakeholder representation from European umbrella interest organizations among the identified stakeholders.

The functions will be serviced and facilitated by a EUnetHTA Collaboration secretariat. It is paramount that an adequately resourced secretariat is in place to coordinate and manage the basic communication and tools of the EUnetHTA Project that can be utilized in the long-term EUnetHTA Collaboration.

It should be emphasized that the EUnetHTA Collaboration will not be a “European Agency” (EUnetHTA, 2008).

Focus on HTA collaboration in Europe

The EUnetHTA Collaboration aims to support HTA in Europe. At the outset, work will focus on HTA agencies and institutional producers of HTA in the 27 EU Member States and the countries in the European Economic Area (EEA) and European Free Trade Association (EFTA). The EUnetHTA Collaboration will also continue the collaboration established between HTA agencies and producers in other European countries by the EUnetHTA Project and develop links with new organizations and countries. The EUnetHTA Collaboration will explore ways of coordinating and collaborating with WHO in Europe. However, EUnetHTA’s focus on collaborating with institutions in European countries should not be seen as lack of interest in HTA activities elsewhere or at global level. The focus on Europe allows EUnetHTA to engage in spheres of

15Transnational collaboration on health technology assessment – a political priority in Europe

interest that can be influenced and that influence the implementation of HTA in health policy. This provides a unique added value compared with other HTA networks.

Relations with global HTA community and international organizations

Within the international HTA community, a number of global organizations are natural collaborators for the EUnetHTA Collaboration. For example, the International Network of Agencies for HTA (INAHTA), HTA International (HTAi), International Information Network on New and Changing Health Technologies (EuroScan), Guidelines International Network (G-I-N) and the Cochrane Collaboration. It is an explicit goal to avoid duplication of activities between the organizations and to seek synergies through coordination. The EUnetHTA Collaboration’s focus on European added value and on decision- making in Europe sets it apart from other organizations in the international HTA community. However, the activities of the organizations are linked in different ways and coordination and division of work is necessary to obtain the best possible synergies of interaction. This will be accomplished through ongoing dialogue with the relevant organizations.

The EUnetHTA Collaboration is particularly interested in working with international organizations related to health, including:

European Commission•

Council of Europe•

WHO Regional Office for Europe.•

In addition, consideration will be given to links with international organizations such as the OECD.

The longstanding interest and support from the Directorate-General for Health and Consumer Protection (DG SANCO) will be stimulated to enable the EU to support the EUnetHTA Collaboration, which will facilitate HTA to inform health policy in Member States and other countries across Europe.

Stakeholders in HTA

Patients, health management, the health professions, industry, third-party payers and government are some key stakeholders in health-care policy and decision-making. Each has legitimate interests in the search for, and handling of, information on the best use of health technologies that inform policy processes.

16 Health Technology Assessment and Health Policy-Making in Europe

EUnetHTA plans to establish an advisory council to ensure transparency and early involvement of HTA-relevant stakeholder groups in the development process, depending on the needs of the stakeholders and the project.

The EUnetHTA Collaboration acknowledges the interests of stakeholders in general issues related to HTA processes, specific HTAs at the national level and in the general work of the EUnetHTA Collaboration. The by-laws/ statutes of the EUnetHTA Collaboration will ensure that its obligations relate to its partners, funders and the work they undertake, and are independent of stakeholder interest. However, the views of stakeholders will be sought in a systematic way to inform EUnetHTA’s work and its development.

Within the HTA process, the EUnetHTA Collaboration focuses on methodological development, information collection and analysis of specific health technologies with the aim of presenting information that may be used at national or regional level for context specific HTA. The EUnetHTA Collaboration has an interest in communicating with stakeholders about general HTA processes and issues. As such it will engage with stakeholders that are partnership- or interest-based umbrella organizations working at the European level. It will have no role in stakeholder involvement at national or regional level.

The points of contact for engagement with stakeholders include:

national and regional policy-makers;•

policy-makers at hospital level, in statutory health insurance or health • maintenance organizations;

patients’ organizations; •

health-care professionals and their organizations; •

industry; •

health-related media.•

Clear and transparent stakeholder involvement processes will be developed (e.g. rules of engagement and disclosure of competing interests) to ensure that balanced stakeholder views are obtained to advise on the work of the EUnetHTA Collaboration.

Conclusions

Articulate political commitment to, and European collaboration on, HTA has made it possible to obtain extensive political support from national and regional governments and the European Commission for the EUnetHTA Collaboration.

17Transnational collaboration on health technology assessment – a political priority in Europe

A group of founding partner organizations will develop this on the basis of the proposal endorsed by the EUnetHTA Project Steering Committee in 2008 (EUnetHTA).

Further reporting on the EUnetHTA Project’s results in the Autumn 2009 Journal of Technology Assessment in Health Care.

References Banta HD et al. eds. (1997). Report from the EUR-ASSESS Project. International Journal of Technology Assessment in Health Care, 13:133–340. Banta HD, Oortwijn W, eds. (2000). Health technology assessment in the European Union. International Journal of Technology Assessment in Health Care; 16:299–635. EUnetHTA [website] www.eunethta.net. Europa [web site]. Europa Glossary. (http://europa.eu/scadplus/glossary/comitology_en.htm, accessed 30 July 2008). European Commission (2007). Programme of Community action in the field of health and consumer protection 2008–2013. Brussels (http://europa.eu/scadplus/leg/en/cha/c11503c.htm, accessed 19 September 2008) European Commission (2008a). Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (presented by the Commission). Brussels, 2 July 2008, COM(2008) 414 final (http://ec.europa.eu/health-eu/doc/ com2008414_en.pdf, accessed 19 September 2008). European Commission (2008b). Communication from the Commission: a Community framework on the application of patients’ rights in cross-border healthcare. Brussels, 2 July 2008, COM(2008) 415 final (http://ec.europa.eu/health-eu/doc/com2008415_en.pdf, accessed 19 September 2008). Jonsson E et al. eds. (2002). European collaboration for health technology assessment in Europe. International Journal of Technology Assessment in Health Care, 18:213–455. Kristensen FB (2006). EUnetHTA and health policy-making in Europe. Eurohealth, 12(1):36–38. Notes of the Trio Presidency (2007). Health care across Europe: striving for added value. Aachen, 20 April 2007 (http://www.eu2007.de/en/News/download_docs/April/0419-BSGV/090Triopapier. pdf, accessed 19 September 2008). OECD (2005). Health technologies and decision-making. The OECD Health Project. Paris (http:// www.sourceoecd.org/scienceIT/9264016201, accessed 16 September 2008). Official Journal of the European Union (2006). Council conclusions on common values and principles in European Union health systems. C 146/01, Volume 49, 22 June 2006 (http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:146:0001:0003:EN:PDF, accessed 19 September 2008). Sorenson C, Kanavos P, Drummond M (2007). Ensuring value for money in healthcare – the role of HTA in the European Union. In: Financing sustainable healthcare in Europe: new approaches for new outcomes (Cox Report), Ministry of Health, Luxembourg and Sitra, the Finnish Innovation Fund. (http://www.sustainhealthcare.org, accessed 16 September 2007). Sorenson C et al. (2008). How can the impact of health technology assessment be enhanced? Copenhagen, WHO Regional Office for Europe (Policy Brief ). WHO (2007). WHO resolutions and decisions, EB120.R21, Health technologies, 29 January 2007. WHO (2008). The Tallinn Charter: health systems for health and wealth. (http://www.euro.who. int/document/e91438.pdf, accessed 16 September 2008).

Chapter 2

Policy processes and health technology

assessment Camilla Palmhøj Nielsen, Antonio Sarriá Santamera, Hindrik Vondeling

Introduction

Decision-makers throughout Europe have a common goal of raising health standards in order to improve the health status of the European population. Health service delivery is carried out under conditions of growing political and economic complexity – rapid technological change puts pressure on health- care systems to add new preventive, diagnostic, treatment and rehabilitative interventions to their existing arsenal of technologies. This pressure is ongoing and it is difficult for providers of health services to live up to the expectations of all users. Limited resources require decisions on the introduction of new technologies and the use of those already available.

Health technology assessment (HTA) provides evidence-based input to the policy-making processes concerning the use of technology in health services and thereby seeks to promote evidence informed policy-making. It has the potential to function as a mediating mechanism between policy and research domains by providing a problem oriented systematic overview of research. However, this is dependent upon HTA producers having a thorough and detailed knowledge about policy-making and its conditions, and its users being aware (and having positive experiences) of the use of HTA. This need to share knowledge and experiences between producers and users sets the standard for future success in ensuring evidence informed policy-making. Therefore, the utilization of HTA in policy-making depends very much on mutual understanding and responsiveness to user needs.

20 Health Technology Assessment and Health Policy-Making in Europe

In this chapter we aim to describe the role of HTA in policy processes from the perspective of political science. We begin with a brief introduction to HTA, presenting its role and function in both policy processes and democratic processes in general. This is followed by a discussion of the barriers to utilizing HTA in policy-making with a focus on the disconnect between research and policy.24 We argue that this presents challenges that require improved connections between research and policy in order for HTA to provide successful input to policy-making. As a starting point, a number of research utilization models are presented and discussed in terms of their potential contribution to solve this problem. Finally, we present some recent global developments to illustrate how societal changes can potentially act as facilitating factors to increase the demand and use of HTA in health-care policy-making.

HTA

It is necessary to know what HTA is in order to get an impression of how it can function as an input to policy-making. Described and discussed in detail in Chapter 3, in short – HTA is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased robust manner. It aims to inform the formulation of safe, effective, health policies that are patient-focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method (www. eunethta.net).

HTA primarily aims to support policy-makers in making evidence-informed decisions on the application of health technologies. It can be regarded as a flexible, ongoing process, guiding technology from its future status to the phase of obsolescence (Banta & Luce, 1993).

Health technology (see Chapter 3 for more detail) is defined as the application of scientific knowledge in health care and prevention. It covers a broad range comprising diagnostic and treatment methods; medical equipment; pharmaceuticals; rehabilitation and prevention methods; and the organizational and supportive systems within which health care is provided.

The role and function of HTA

Policy processes

Policy processes are typically understood as connected stages during which 2 The empirical evidence on the barriers and facilitators from the perspective of HTA users is summarized and discussed in Chapter 7.

21Policy processes and health technology assessment

policies are formulated, decided and implemented in particular social, political and historical contexts. These contexts matter – they have distinct influences on what is put on the agenda; how policies are formulated, resources allocated and policies implemented; and on the outcomes of the policies (Mackintosh, 1992). The policy process has been described in different ways by different policy researchers and therefore the models generally include different terminology and/or stages. A very simple ideal model of a policy process is illustrated in Fig. 2.1.

This model implies that policy-making is a technical, linear and rational process. This is rarely the case. Policy analysts are preoccupied with explaining and conceptualizing policy processes and have proposed several different models that represent both (partly) rational and less rational models. A few of the models which have impacted on the theoretical discussions and empirical studies of policy processes are outlined below.

Muddling through model • (Lindblom, 1959). A reaction to the rational understanding of policy processes. It emphasizes incrementalism as a predominant characteristic of policy processes. Lindblom claims that policy develops through evolution rather than revolution therefore the wise policy-maker makes incremental changes to reduce uncertainty and avoid mistakes.

Fig. 2.1 Simple ideal model of a policy process

22 Health Technology Assessment and Health Policy-Making in Europe

Garbage can• model (Cohen et al. 1972; March & Olsen, 1976). Reflects the understanding that uncertainty in organizations triggers behaviour which (at least from a distance) appears irrational. In contrast to earlier models it separates problems, solutions and decision-makers. Policy processes comprise different streams: problems, solutions, choice opportunities and participants. These enter a “garbage can” which functions as a reservoir for policy-making when problems arise that demand the formulation of policies. Specific policy decisions do not follow an orderly process from problem to solution but rather are outcomes of several relatively independent streams of events.

Easton’s model of a political system • (Easton, 1953). Represents a system approach to policy-making. A dynamic and open model which assumes that decisions are made in response to pressure/input from voters. This input leads through decision-making to the formulation of policies. The model treats the decision-making process as a “black box” and does not describe how this part of the process takes place. Policies change continually in response to voters’ input.

Advocacy coalition framework • (Sabatier & Jenkins-Smith, 1993 & 1999). Also takes a system approach, focusing on the analysis of long-term changes in a policy field explained by coalitions formed between policy-makers, influential actors and pressure groups. The model settles with the stage heuristics (an integral part of most policy process models) by focusing on long-term developments rather than specific policy processes.

All the models have contributed to the understanding of how policy processes function in reality under everyday conditions and have been formulated as different reactions to linear, rational understanding of the processes. Empirical studies of policy processes are typically concerned with questions regarding why, how, who and by whom. They also focus on the context parameters of specific policy processes in order to understand the actual course of action. When policy is conceptualized as a process affected by context there is an immediate implication that the processes are likely to vary between them (e.g. across political systems, countries, regions, lower administrative levels and organizations). Nevertheless, some of the more general theories are relevant across different settings and can therefore structure broader discussions across contexts.

The role and function of HTA are often discussed in general terms using a simple linear model of the policy process as a starting point (see Fig. 2.1). Typical questions are: How can HTA contribute as an input to decision-making? How do HTA producers ensure that policy-makers are aware of HTA reports

23Policy processes and health technology assessment

that can support policy-making? HTA’s role is to create links between the policy and the research domains. It is an activity that can be understood only by analysing its context as this determines the best timing and the best possible way in which influence can be exerted on policy processes. At a project level – i.e. for a particular assessment – the link between HTA and policy-making is ensured when an HTA takes a specific policy question as a starting point. This is transformed into a number of HTA questions which can be answered through systematic reviews and analysis of research results. The answers and results are synthesized in an HTA report which is used as a basis for evidence informed decision-making within the policy process (Busse et al. 2002; Kristensen & Sigmund, 2007).

The actual utilization of HTA in policy processes takes very different shapes and depends on a number of factors such as the remit and responsibility of the HTA agency; timing of a specific project; or the way that HTA enters into the process. However, it is characteristic that HTA aims to bring more rationality as it can help to solve policy problems that lack the information or understanding to either generate a solution or select among alternative solutions (Weiss, 1977). The goal is to provide policy-makers with information on policy alternatives such as the allocation of research and development funds; formulation of regulations; or the development of legislation (Banta & Luce, 1993). Generally, this implies that HTA is most suited for (and most successful in relation to) approximated rational policy processes. Policy-makers are involved in formulating the policy problems and demand HTA as the basis for decision-making, with the HTA process timed in accordance with their needs.

It is recognized that HTA provides only one input for decision-making. It is usually not the only source, nor is it always the most important input (see also Box 4.3 in Chapter 4). For this reason an HTA (or its recommendations) should not be confused with the actual decision taken. Fig. 2.2 illustrates this point.

Nevertheless, HTA can provide important evidence-based input and thereby inform policy-makers even though public opinion cannot perceive the process (and perhaps also the decisions) as rational. Though research findings are not directly employed in a specific policy they can still influence the process of agenda-setting, the terms used and the way in which policy problems are framed and understood.

If policy processes are not always rational this also suggests that policy- makers may use HTA results in a manner other than that originally intended. Weiss (1977) and Vedung (2000) suggest that HTA can be used as ammunition in political debates. From time to time constellations of interests around a

24 Health Technology Assessment and Health Policy-Making in Europe

policy issue predetermine the position that policy-makers take and ensure that they are not receptive to new evidence. A stand adopted for reasons of ideology, interest or political pressure is not likely to be changed by HTA. However, the results of a particular HTA report can still be used by those that find its results most congenial and supportive. This can also be considered utilization of HTA in policy processes, even if it does not qualify as “intended use by intended users” (Patton, 1990).

In addition, HTA may be used to avoid taking responsibility for a decision, to postpone action or take credit for successful interventions. But even in instances where reports are not used rationally (but rather for strategic or tactical purposes) HTA can still have a valid and instrumental function. The analysis can form the basis of efficient implementation if it is decided that the technology should be introduced.

Democratic processes

Although not always utilized as intended in policy processes, HTA can still play an important role in democratic processes. Democracies in Europe are typically organized as representative democracies in which politicians are elected to act on behalf of voters. Voters elect the politicians that best represent their preferences and opinions. When dissatisfied, they have the opportunity to vote

Fig. 2.2 Factors that influence policy-making

Source: adapted from Davies, 2005

25Policy processes and health technology assessment

differently in the next election. However, politics is very complex and difficult to assess so voters need as much insight and transparency as possible to allow them to evaluate the performance of their elected politicians. HTA provides transparency and thereby offers a foundation for ensuring accountability for government decisions and performance (Chelimsky, 2006). In particular, citizens can gain more insight into arguments for and against the decisions made and can use this information to evaluate the legitimacy of the policy- makers (De Peuter, 2007).

Barriers – disconnect between research and policy

The idea of linking policy and research through HTA seems obvious but some basic barriers have to be addressed. A main issue is that researchers and policy-makers comprise two very different communities with different values, ideologies, languages, backgrounds, institutional settings and reward systems etc. As discussed in Chapter 7, these two communities have very different interests which influence the traditionally expected output from research and the demands for input to policy. The characteristics of the two communities are summarized in Table 2.1.

Table 2.1 Policy and research communities: different notions of knowledge

Policy Research

Understanding of knowledge Colloquial Scientific

Time frame for production of knowledge

On time, timely Systematic, as long as it takes

Relevance of knowledge Policy relevant Research relevant, theoretically

driven

Criteria for validity of knowledge

Anything that seems reasonable Proven empirically

Format of knowledge

Short and to the point, clear messages

Thorough; discuss caveats, strengths and weaknesses

Source: adapted from Davies, 2005

Policy-makers need context-specific input to fit the particular purpose. This input should be timely; reliable (therefore useful in policy negotiations); concise (so policy-makers waste no time) and address specific policy problems (thereby ensuring relevance). By contrast, researchers often provide more context-free knowledge using systematic and cogent approaches which do not

26 Health Technology Assessment and Health Policy-Making in Europe

always allow timely inputs to policy-making. The general demand that output should be research relevant means that often it does not capture current policy problems on the political agenda. Validity and thoroughness are good qualities from the research perspective but they may collide with the need of policy- makers. Basically, researchers are occupied with science while policy-makers are action-oriented and concerned with obvious and immediate issues.

These generalized descriptions emphasize the differences between the two communities but do not reflect that these barriers have already been lowered by collaboration between policy-makers and researchers. There are many good examples of research driven by interest in providing policy relevant knowledge for health-care problems that require political action (e.g. research on the social determinants of health). However, despite the limitations and simplicity of the model, the differences between the two communities can largely explain why research is underutilized in the relationship between the researcher/research system and the policy-maker/policy-making system. Given that the values and ideologies of the two communities constitute patterns of behaviour, a great deal of effort is required to break down the barriers. More and better contact between the groups may improve understanding but will not necessarily increase the use of research in policy-making. More structured attempts will be necessary to overcome these barriers.

The different research utilization models are categorized below in order to enable more detailed discussion of this subject.

Technological• – science push model. Supply of research findings is the major determinant of knowledge utilization and uptake.

Economic • – demand pull model. Use of knowledge is increased when researchers focus their projects on the needs of users rather than the advancement of scholarly knowledge alone.

Institutional• – dissemination model. Two factors influence the level of knowledge utilization: (i) disseminated research products adapted to meet policy-makers’ needs, and (ii) dissemination effort.

Social interaction• – the more sustained and intense the interaction between researcher and users at all stages of knowledge production, dissemination and utilization, the more likely it is that the research will be utilized.

The first model corresponds with the described disconnected relationship between researchers and policy-makers. The three other models present alternatives where the links and interaction between the two become increasingly intense. The social interaction model is compatible with the notion that a particular new kind of knowledge production (Mode 2) has come into being (Gibbons

27Policy processes and health technology assessment

et al. 2002). In this context, traditional academic research is called Mode 1 knowledge production. Mode 2 knowledge production has, for example, the following characteristics.

Produced in a context of application – knowledge production is organized • around a particular application or policy problem. It is intended to be useful for someone, and this imperative is present from the beginning of the knowledge production. Mode 2 must include the interests of the users.

Socially accountable – sensitivity to the impact of the research is built in • from the outset. Social accountability permeates the whole knowledge production and is reflected not only in the interpretation and diffusion of results but also in the definition of the problem and the setting of research priorities.

Incorporates a range of interest within the specific context of application – • in addition to traditional scientific quality control (peer review), the ability to incorporate stakeholder interests and produce socially acceptable inputs to policy-making are part of the quality criteria.

HTA may be considered to be Mode 2 knowledge production, and linked with the social interaction research utilization model, as it is often recommended to maintain ongoing dialogue with stakeholders for specific projects and for the performance of HTA organizations (Kristensen & Sigmund, 2007; Kristensen, 2006; OECD, 2005; Sorensen et al. 2008). Thus, HTA offers a bridge between the research and policy communities. Barriers and challenges remain (and HTA producers can clearly become better at overcoming these) but HTA is now considered to be an important tool for informing the effective regulation of the diffusion and use of health technologies (Sorensen et al. 2008).

Factors that facilitate the role of HTA in policy-making

In order to improve HTA’s input to policy-making it is necessary to understand potential facilitating factors. In the wider political and societal context, these may positively influence the uptake of HTA in decision-making at different levels of the health-care system and are discussed in more detail below.

Evidence-informed policy has been promoted by general trends towards a knowledge society (Bhatti et al. 2006; De Peuter, 2007). Governance and policy-making have generally become more knowledge intensive and there has been a growth of related institutions (e.g. HTA organizations, Cochrane Collaboration, Campbell Collaboration). Growing complexity and the rapidly increasing pace of change have made knowledge production and management within government increasingly important points of interest. At the same time

28 Health Technology Assessment and Health Policy-Making in Europe

views of quality standards of information and of what constitutes knowledge/ evidence are heavily debated (Wothern et al. 2003). HTA is part of this debate and also one of the driving forces in promoting evidence-informed policy- making.

Fiscal distress is a potential driver for the use of HTA within the public sector as it often promotes a focus on value-for-money and effective use of resources during attempts to decrease budget deficits (De Peuter, 2007). Economies under pressure require politicians to pay extra attention to how they spend money; HTA can provide valuable information to assist politicians to prioritize and allocate budgets to the most cost-effective activities.

Intergovernmental policy-making also facilitates the utilization of HTA. This takes place between national and subnational (regional/ local) government levels and between national government and European levels. National and subnational government levels are handling more and more policy issues in concerted action within network models (Rhodes, 1999). This shift has an impact on the information flow within governments as successful coordination and control depends on the way that the supply and demand of policy information is matched within and between public sector organizations. Intergovernmental collaboration is also visible between the European institutions and Member States, regional actors and interest groups. Even as these relationships change, some policy issues are difficult to solve at Member State level (e.g. globalization and innovations) and therefore there are external pressures for cross-border and supranational collaboration on a number of policy problems (De Peuter, 2007). This also applies to HTA – the EUnetHTA Project clearly addresses the needs for Member State and European intergovernmental collaboration.

Finally, the increasing complexity of policy-making in general can act as a facilitating factor. As policy issues become more and more interdependent they involve a large variety of actors/stakeholders in collaborations to solve complex problems across administrative boundaries. Such horizontal interdependence between policy fields requires a broad view on the policy context as well as multidisciplinary inputs to policy-making (De Peuter, 2007).

These trends describe only a small number of possible factors that either promote or hinder the use of HTA. Other factors emerge in relation to HTA programmes (organizational set-up) and projects (project set-up). These are addressed in later chapters.

29Policy processes and health technology assessment

Conclusions

HTA has a unique potential to contribute to policy-making, strategic planning, management and the implementation of technologies in health care. It can be used as a strategic tool to overcome the disconnect between policy and research but it cannot be guaranteed that fulfilling a number of preconditions ensures that HTA is used as intended. Nevertheless, it may still have the potential to be useful in strategic planning, management and the implementation of technologies.

Also, HTA has a general function in democratic processes since it creates transparency and can help to ensure accountability for government decisions and performance. This function is evidently linked to policy-making within the health-care field, but developments towards a more general knowledge society cause other sectors to use research as an input to decision-making and thereby promote transparency and accountability in government performance. Finally it is shown that global trends and societal developments potentially facilitate the demand for HTA. All in all HTA has a great potential to contribute to policy-making if it is performed wisely; in line with user needs and demands; and if the producers work to overcome the barriers between research and policy.

References Banta HD, Luce BR (1993). Health care technology and its assessment. An international perspective. Oxford & New York, Oxford University Press. Bhatti Y, Hansen HF, Rieber O (2006). Evidensbevægelsens udvikling, organisering og arbejdsform. En kortlægningsrapport [The evidence movement’s development, organisation and mode of work: an analysis]. Copenhagen, AKF Forlaget. Busse R et al. (2002). Best practice in undertaking and reporting health technology assessments. International Journal of Technology Assessment in Health Care, 18(2):361–422. Chelimsky E (2006). The purpose of evaluation in a democratic society. In: Shaw IF, Greene JC, Mark MM eds. The Sage handbook of evaluation. London, Sage Publications. Cohen MD, March JG, Olsen JP (1972). A garbage can model of organizational choice. Administrative Science Quarterly, 17(1):1–25. Davies P (2005). Evidence-based policy at the cabinet office. Presentation at the Impact and Insight Seminar, London, 17 October 2005. London, Overseas Development Institute (http://www.odi. org.uk/rapid/Events/Impact_Insight/docs/Phil_Davies.ppt., accessed 29 September 2008). De Peuter B (2007). Evidence-based policy: an exploration of drivers and challenges in Belgium. Paper for the Symposium on Evaluation in the Knowledge Society, Odense, Denmark, 18-19 October 2007. Leuven, Belgium (http://soc.kuleuven.be/sbov/rapport/s2A0406001_2007_ DePeuter-EBP_in_Belgium.pdf, accessed 29 September 2008). Easton D (1953). The political system: an inquiry into the state of political science. New York, Alfred A Knopf. EUnetHTA (2008) [web site]. Copenhagen (www.eunethta.net, accessed 29 September 2008).

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Gibbons M et al. (2002). The new production of knowledge. The dynamics of science and research in contemporary societies. London, Sage Publications. Kristensen FB (2006). EUnetHTA and health policy-making in Europe. Eurohealth, 12(1):36– 38. Kristensen FB, Sigmund H (2007). Health technology assessment handbook. Copenhagen, Danish Centre for Health Technology Assessment, National Board of Health. Lindblom CE (1959). The science of “muddling through”. Public Administration Review, 19(2)79–88. Mackintosh M (1992). Introduction. In: Wuyts M, Mackintosh M, Hewitt T eds. Development and public action. Oxford, Oxford University Press. March JG, Olsen JP (1976). Ambiguity and choice in organizations. Oslo, Universitetsforlaget. OECD (2005). OECD Health Project – health technologies and decision making. Paris, OECD Publishing. Patton MQ (1990). The evaluator’s responsibility for utilization. In: Alkin MC. Debates on evaluation. Newbury Park, Sage Publications. Rhodes RAW (1999). Control and power in central-local relations. Aldershot, Ashgate Publishing. Sabatier PA, Jenkins-Smith HC eds. (1993). Policy change and learning – an advocacy coalition approach. Boulder, Westview Press. Sabatier PA, Jenkins-Smith HC (1999). The advocacy coalition framework: an assessment. In: Sabatier PA ed. Theories of the policy process. Boulder, Westview Press. Sorensen C et al. (2008). How can the impact of health technology assessment be enhanced? Copenhagen, WHO Regional Office for Europe (Policy Brief ). Vedung E (2000). Public policy and program evaluation. New Brunswick, Transaction Publishers. Weiss C (1977). Using social research in public policy making. Lexington, Lexington Books. Wothern BR, Sanders JR, Fitzpatrick JL (2003). Program evaluation: alternative approaches and practical guidelines. Reading, Addison-Wesley.

Chapter 3

What is health technology

assessment? Finn Børlum Kristensen , Camilla Palmhøj Nielsen, Debbie Chase,

Kristian Lampe, Sun Hae Lee-Robin, Marjukka Mäkelä

Introduction

In this chapter we provide a general introduction to the meaning of health technology assessment (HTA) and how it can contribute to informing health- care policy-making. We describe the methodological streams that contributed to forming HTA as a multidisciplinary field of policy analysis and briefly describe the process of moving from assessments through recommendations to policy-making.

The description of the process of performing HTA is based on the methodological developments which have taken place in both European and joint international HTA projects since the 1990s. This is followed by a description of the development of joint international HTA reports. We conclude by presenting the vision of the EUnetHTA Project in relation to improving European collaboration on the production of HTA.

Definition of HTA

The International Network of Agencies for Health Technology Assessment (INAHTA) defines health-care technology as: “…prevention and rehabilitation, vaccines, pharmaceuticals and devices, medical and surgical procedures, and the systems within which health is protected and maintained.” Technology assessment in health care is defined as: “…a multidisciplinary field of policy analysis. It studies the medical, social, ethical and economic implications of

32 Health Technology Assessment and Health Policy-Making in Europe

development, diffusion, and use of health technology” (http://www.inahta.org/ HTA/).

The EUnetHTA Project has added the following explanatory clarification that emphasizes the process and aims of an assessment:

Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method (Kristensen, 2006).

The practice of HTA within this definition varies considerably across national settings. It informs policy- and decision-making in specific political, economic and institutional contexts. In order to be useful HTA has to be designed with processes and outputs that fit the relevant context.

From assessment to recommendations and policy-making

The role of HTA has been described as a bridge between research and decision- making (Battista & Hodge, 1995). Fig. 3.1 illustrates the close relation between HTA and policy-making and depicts the interdependence and separation between research-based assessment and decision-making. A successful process from a policy question to an HTA report that informs policy will span paradigms in a conscious and transparent way.

A majority of EU Member States have public sector HTA agencies that provide information for decision- and policy-making at regional or national levels. Their primary aim is to produce and disseminate HTA reports. In order to optimize the usefulness of HTA, the concrete format of the reporting has to fit into the policy setting for which it provides information. As a consequence some HTA reports may include specific recommendations for policy; others provide only synthesis and conclusions. The credibility of HTA information and clarity on roles in the policy processes depend on producers and users having clear knowledge of the formal status of HTA reports and the practice that reflects this, as reflected in the following example.

The HTA programme in England was established in 1993 as part of the National Institute for Health Research (the research arm of the English National Health Service) (Walley, 2007). The National Institute for Health and Clinical Excellence (NICE) was established in 1999 to appraise technologies at a national level, thereby avoiding local variations in approval and practice that

33What is health technology assessment?

are considered unacceptable in a national health service. The Secretary of State for Health decides on NICE’s topics based on advice from expert review panels and filtered through a policy review board. The process is managed by NICE itself.

There is a clear distinction between assessment (a scientific process and the role of the HTA programme) and appraisal (the role of policy-makers like NICE). The HTA programme supports all NICE technology appraisals by commissioning independent assessments of the evidence, accompanied by economic evaluations and reviews of manufacturers’ submissions. These inform the decisions of NICE’s appraisal committees and are made publicly available once a preliminary decision has been made. The assessments do not provide recommendations to the committee.

It is necessary to recognize that practice varies considerably across national settings, and it is extremely important to have a clear understanding of the formal status of HTA reports in a specific context (see also Chapter 4).

Development of HTA

The advance of scientific knowledge has been accompanied by opportunities and problems. In 1967, recognition of the growing importance of accurate, timely and independent information to enhance understanding led to the

Fig. 3.1 From policy questions to HTA reports that inform policy

Source: Kristensen, 2002.

-

34 Health Technology Assessment and Health Policy-Making in Europe

first legislative proposal for an agency to evaluate the impact of technological developments in the United States of America. In 1972, the proposal was enacted into law with the creation of the congressional Office of Technology Assessment (OTA). Although this closed in 1995 (OTA, 1996), remarkably the director’s statement in the first annual report still reflects the ethos of international HTA:

Technology assessment is a process designed to ask the right questions, and to seek answers based – as much as is possible – on hard, factual information which can be obtained through disciplined analysis. Where important data are unavailable, the need for additional research can be spotlighted. Technology assessment is an aid to, not a substitute for, the judgments which must be reached by elected officials in policy-making positions (OTA, 1975).

The rapid increase in new diagnostic and therapeutic interventions in health (such as scanners and pharmaceuticals) quickly led to OTA initiatives to address health technologies (Banta, 2003).

After its introduction in the 1970s, technology assessment developed into two main streams.

International development of technology assessment which over time has 1. maintained focus on informing parliamentary committees. Uses consensus conferences and other means to combine scientific input with citizens’ views. European Parliamentary Technology Assessment (EPTA) partners advise parliaments on the possible social, economic and environmental impact of new sciences and technologies. Common aim is to provide impartial and high-quality accounts and reports of developments in issues such as bioethics and biotechnology; public health; environment; and energy (http://www. eptanetwork.org/EPTA).

International development of HTA with the establishment of more than 50 2. agencies serving national or regional governments; a scientific society; an international journal; an international association of agencies; and several EU funded projects (see Chapter 1).

Methodological streams

Four main streams of applied research methodology have contributed to the development of HTA: (i) policy analysis; (ii) evidence-based medicine; (iii) health economic evaluation; and (iv) social and humanistic sciences. Policy analysis sets a general framework for HTA as an input to policy-making. Evidence- based medicine (i.e. clinical epidemiology) and health economic evaluation

35What is health technology assessment?

set the methodological frames for the analyses carried out as part of an HTA. In addition, HTA includes the application of methodologies from social sciences and humanistic research. This is especially true when meeting the requirements of a full HTA in accordance with INAHTA’s general definition.

Policy analysis

Traditionally, policy analysis includes analysis of policy content, outputs and processes (Hill, 2005). HTA has particularly been inspired by the part of the policy process that focuses on how policy decisions are made and how policies are shaped in action with the involvement of stakeholders. This is particularly important since HTA needs to enter into the policy processes in order to be able to fulfil its aim of functioning as an input to decision-making.

Chapter 2 describes policy processes in more detail and presents a simple ideal model of a policy process (Fig. 2.1) that includes the following stages:

agenda setting•

policy formulation•

decision•

implementation•

evaluation.•

HTA can potentially enter the policy process at different stages (e.g. agenda setting, policy formulation or evaluation) but always with the aim of informing the decision.

Systematic policy analysis typically includes the following inputs: goals to be achieved; alternatives available to achieve them; and relations between goals and alternatives. Typical outputs are tentative conclusions on the best alternative, combination or allocation as well as “what-if ’” analysis to show how these may be affected by changing inputs (Nagel, 1994). In this framework HTA provides a policy analysis which aims to include both the input (e.g. the goals, alternatives and relations surrounding the specific policy) and the output elements. Effective HTAs require close communication and dialogue between policy-makers (having most involvement in setting inputs) and HTA producers (those producing the outputs).

HTA differs from traditional policy analysis in one important respect. Policy analysis is predominantly retrospective – contrasting the outcomes of existing policies with their original goals and using this analysis to propose further policy development. In contrast, HTA is primarily prospective – aiming to inform policy processes before the formulation of policies or a formal decision.

36 Health Technology Assessment and Health Policy-Making in Europe

However, analysis of the context of existing policies and their implementation may also be a relevant element of an HTA report.

Within policy analysis, a growing literature on “information for policy-making” is currently contributing to the development of HTA. This is mostly concerned with analysing the potential barriers to, and consequences of, using evidence in policy-making (Hill, 2005; Davies et al. 2000). This literature has the potential to influence HTA to clarify its relation to policy processes.

Evidence-based medicine

The roots of evidence-based medicine (EBM) stem from the introduction of the scientific method in clinical medicine during the nineteenth century (e.g. the contributions of Bernard, Koch, Pasteur and Fibiger in France, Germany and Denmark) and the development of clinical epidemiology and systematic reviews of research literature. However, the concept of EBM was first introduced in a number of seminal journal articles from a group led from McMaster University in Canada (Evidence-Based Medicine Working Group, 1992).

During the 1980s, work on systematic reviews in perinatal medicine led to the publication of Effective care in pregnancy and childbirth by a large international group led from Oxford (Chalmers et al. 1989). This helped to build a solid foundation for determining the degree and application of evidence for diagnosis and intervention in one field of health care and encouraged a number of initiatives. For example, BMJ Clinical Evidence covers an increasing range of health-care interventions. The establishment of the Cochrane Collaboration in 1993 has made a key contribution and EBM is now well-established as a vision (and increasingly as a practice) in European health care (Cochrane, 1989).

Health economic evaluation

Health economics aims at a societal perspective and emerged as a separate field in the 1970s (Maynard, 2005). Cost-benefit analyses had been applied to other public sectors, such as transport, but increasing pressure on health-care budgets led to the development of academic and practical health economics (Williams, 1974). Reflecting the diverse needs for economic analysis from institutional to societal level the scope and tools of health economics now range from simple cost analyses to cost-effectiveness analyses – in which the effects are measured in clinically relevant parameters e.g. cost per saved life or cost per avoided stroke. Cost-benefit analyses – in which effects are also valued in monetary units – are undergoing new developments (Poulsen et al. 2007). The methods of health economic analyses are not standardized across Europe. However, best practice is increasingly identifiable while methodology is still being developed and debated

37What is health technology assessment?

in areas such as the incremental cost-effectiveness ratio with modelling based on quality-adjusted life years (QALYs) (Poulsen et al. 2007).

Health economic analysis in HTA assesses the socioeconomic consequences of the influence of health technologies on patients’ return to the labour market; the need for disability compensation and other macroeconomic factors. However, HTA does not assess all macroeconomic aspects of health technologies. It is beyond its scope to assess the influence of the degree of application of certain technologies (such as devices or pharmaceuticals) on the gross domestic product, or to provide supporting evidence to increase the competitiveness of certain industries. These issues can be addressed by stakeholders.

The Lisbon Strategy for Growth and Jobs was the basis for the establishment of the Pharmaceutical Forum by the Directorate-General for Health and Consumer Protection (DG SANCO) and the Directorate-General for Enterprise and Industry. This aims to balance a high level of public health with support for a competitive pharmaceutical industry to ensure that Europe continues to benefit from new medicines. In 2007, the European Medical Technology Industry Association (Eucomed) and three universities34founded the European Health Technology Institute for Socio-Economic Research (2007). This is intended to address the lack of evidence on the macroeconomic value of medical technology, including influence on gross domestic products.

Social and humanistic sciences

The social and ethical aspects of health technologies include issues that are not addressed by the assessment of clinical effectiveness and health economic analysis. These include legal matters; the organization of health care; wider societal consequences of health technologies; patient perceptions; and ethics.

As with assessments of effectiveness and cost effectiveness, the assessment of social and ethical issues follows a systematic approach. However, the standards and best practice for this are (by far) most developed for addressing the issues of clinical efficacy and effectiveness in HTA. The review methods of anthropology, sociology and other social sciences are increasingly mobilized for systematic assessments of qualitative research into (say) patients’, citizens’ or organizational aspects (Paterson et al. 2001; Hansen, 2007). This is reflected in the EUnetHTA HTA Core Model, a tool that provides a framework for comprehensive analysis of the elements required in a robust HTA.

3 Technische Universität Berlin, Università Bocconi and London School of Economics.

38 Health Technology Assessment and Health Policy-Making in Europe

Process of HTA – best practice

The process of defining best practice in HTA has been ongoing for several years at a national level and within academia. In 1997 a methodology subgroup of the EUR-ASSESS Project proposed a framework for conducting and reporting HTA (Liberati et al. 1997). Based on this work, and on existing guidelines from HTA agencies and other institutions, a subgroup in the European Collaboration for HTA (ECHTA) Project provided an updated methodological framework in 2002. This proposes a common understanding on HTA reports made by European agencies (Busse et al. 2002).

The ECHTA subgroup concluded that all European HTA producers appear to use a similar process (Fig. 3.2).

It was emphasized that each step of the process might be handled very differently by individual agencies and institutions but analysis of these differences was not included in the ECHTA Project. Instead, attention was directed at providing a general u