thesis muscat

Europeanisation of Health Systems

A Small State Perspective

Natasha Azzopardi Muscat

The research presented in this thesis was conducted at the Department of International Health within the School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine, and Life Sciences, Maastricht University, which participates in the Netherlands School of Primary Care Research (CaRe) and is acknowledged by the Royal Dutch Academy of Science (KNAW).

The work for this thesis was conducted with financial support from the Malta Government Scholarship Scheme.

Dissertation: Europeanisation of Health Systems: A Small State Perspective Author: Natasha Azzopardi MuscatCover design: Ben Borg DesignsLayout and printed by Gildeprint, EnschedeISBN: 978-94-6233-311-6

© Copyright: N. Azzopardi Muscat, Maastricht, the Netherlands, 2016. All rights reserved. No part of this publication may be reproduced without permission of the copyright owner.

Europeanisation of Health Systems

A Small State Perspective

Dissertation

to obtain the degree of Doctor at Maastricht University,

on the authority of the Rector Magnificus, Prof. dr. L. L. G. Soete,in accordance with the decision of the Board of Deans,

to be defended in publicon Tuesday 28 June 2016, at 10:00 hours

by

Natasha Azzopardi Muscat

SupervisorProf. Dr. H. Brand

Co-supervisorProf. Dr. R. Pace (University of Malta)

Assessment Committee:Prof. Dr. D. Ruwaard (chair)Prof. Dr. L. Briguglio (University of Malta)Dr. J. Figueras (European Observatory on Health Systems and Policies)Prof. Dr. E. Versluis

Acknowledgement of funding:The research work disclosed in this dissertation is partially funded by the Malta Government Scholarship Scheme (MGSS).

CONTENTS

Chapter 1 Introduction 7

Chapter 2 Policy Challenges and Reforms in Small EU Member State Health Systems: A Narrative Literature Review 29

Chapter 3 Malta: Health System Review 51

Chapter 4 Europeanisation of Health Systems: A Qualitative Study of Domestic Actors in a Small State 81

Chapter 5 The Impact of the EU Directive on Patients’ Rights and Cross-Border Health Care in Malta 109

Chapter 6 The EU Joint Procurement Agreement for Cross Border Health Threats: What is the Potential for this new Mechanism of Health System Collaboration? 127

Chapter 7 EU Country Specific Recommendations for Health Systems in the European Semester Process: Trends, Discourse and Predictors 145

Chapter 8 General Discussion 163

Valorisation 185Lists of Tables, Figures and Boxes 189List of Abbreviations 191Summary, Samenvatting 193Acknowledgements 201Curriculum Vitae 205List of Publications 207

CHAPTER 1General Introduction

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General Introduction | 9

BACKGROUND TO THE DISSERTATION

The way in which the European Union (EU) impacts upon health systems generates much debate.(1,2) The World Health Organisation (WHO) defines a ‘health system’ as “all organisations, people and actions whose primary intent is to promote, restore or maintain health”.(3) This is a wider definition than the term ‘health care system’ since the term ‘health system’ incorporates the public health and stewardship functions and this all-encompassing term is therefore used throughout this dissertation. At one end of the spectrum, health systems have been described as a “least likely case of Europeanisation”.(4) This observation derives from Article 168 of the Treaty on the Functioning of the European Union (TFEU) which specifies that “Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care”.(5) Furthermore, within the objectives of Europe 2020, the current overall strategy of the European Commission health is not an explicit consideration.(6)

On the other end, various authors have described the far-reaching consequences of developments in the internal market at EU level on health systems.(7-13) These developments are deemed to have culminated in the promulgation of the ‘Patients’ Rights and Cross Border Health Care Directive’.(14) The origins of this directive are traced back to the initial cases brought before the European Court of Justice (ECJ) in 1998.(15-16) Elaboration of the directive had a very tortuous and chequered history with the initial attempts to open health care markets under the services directive (the so-called Bolkestein directive), having been rejected by Member States.(17-19)

Although the legislative framework in the area of health apart from the internal market remains sparse, attention has been drawn to the importance of non-legislative measures and the impact that such measures may have on health systems.(20-23) A good example is the increasing scrutiny of the EU on Member States finances through the European Semester. The expenditure on health systems is also subject to review through this mechanism. The European Semester is an EU-level policy coordination tool contributing towards the broader EU aims of strengthening economic governance and greater policy coordination. It provides a more integrated surveillance framework for the implementation of fiscal policies under the Stability and Growth Pact, as well as the implementation of structural reforms through National Reform Programmes.(24) This mechanism has created yet another opportunity for the EU to exercise influence on its Member States(25-26) leading some to conclude that the EU exercises a more pervasive role on national public health policy and health systems today than has hitherto been the case.(27-28)

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This incursion of the EU in the area of health has not always been welcomed and the traditional narrative where health is concerned, is one in which Member States are considered to jealously guard their sovereignty.(29-30) There is however some evidence emerging that the situation may be changing with European level stakeholders viewing the lack of EU actions in the area of health as a “missed opportunity”(31) and some Member States beginning to respond to fledgling initiatives for health systems cooperation. The final chapter of the patients’ rights and cross border care directive makes reference to health technology assessment, European Reference Networks, e-health and e-prescription as examples of areas for health systems cooperation.(32) It is amidst these developments in European policy that this dissertation is introduced. An understanding of these unfolding processes however warrants an analysis of the developments taking place at European and global levels and the way in which these are impacting upon health systems.

DEVELOPMENTS AT EUROPEAN AND GLOBAL LEVELS

Much of the literature regarding the impact of EU policy on health systems focusses around the internal market rules, particularly patient mobility and cross-border care. Furthermore, this research is largely situated in border regions, mainly in Western Europe,(4,33-36) although a few Member States which acceded to the European Union after 2004 are included in some case studies.(37-39) Significant developments have occurred over the past fifteen to twenty years and these have important implications for the development of health policy at EU level. Three processes have been singled out as being relevant to the scope and focus of this dissertation. The enlargements of the EU since 2004 brought two new realities. Foremost is the reality that countries joining from Central and Eastern Europe had far lower levels of economic development as well as generally poorer health status. The challenges facing the new Member States themselves as well as the old EU Member States, to assimilate and integrate these countries and to overcome structural and health inequalities, had been highlighted around the time of the accession process.(40) An often overlooked dimension associated with the 2004 enlargement is the fact that the EU’s composition changed dramatically with six out of the ten acceding Member States in 2004 having a population under three million. Prior to 2004 the only EU Member State with a population under three million was that of Luxembourg, one of the six founding Member States. The aspirations of small states within the EU are known to be rather different to those of larger countries.(41-42) Secondly, the 2008 financial and economic crisis primarily left an impact on the health systems of those countries most affected, including Greece and Spain.(43-48) However, the austerity measures and new fiscal and economic governance regime adopted at EU level also had wider indirect effects on health systems in general including hospitals.(49)



The emergence of discourse around the need to build sustainable and resilient health systems is worth noting in this context. A third phenomenon is the relentless globalisation of industries which are of high relevance to health systems, such as the pharmaceutical and medical devices, industries which due to a series of mergers and acquisitions over the past two decades have transformed the market into a powerful oligopoly.(50) This development has critical implications both for the EU as well as for individual Member States.

The above three processes are examples of the fast-changing environment in which health systems already struggling to cope with the aging populations, chronic diseases, migration and advances in human genomics, find themselves. Health systems have become highly relevant in terms of their positive contribution to the European economy through the creation of health, wealth, employment and societal well-being.(51) Yet too often, their negative impact on the sustainability of public finances is the narrative that dominates the discourse.(52)

Circumstances for the 28 EU health systems in 2015 are profoundly different to those which prevailed when the principal areas for EU activity were determined by the ‘Founding Fathers’ in the Treaty of Rome. It is therefore deemed opportune to analyse the European integration of health systems. European integration, in a highly simplified description refers to the formation of new political systems at EU level out of existing separate political systems.(53) This analysis is well-timed since according to some observers, health policy is rapidly being marginalised and calls are being made for a renewed impetus to construct a fresh health vision for European public health. It is against this background, particularly considering the EU’s altered configuration in terms of the membership of a number of small Member States, that this dissertation is conceptualised.

SCOPE AND MOTIVATION OF THE DISSERTATION

This dissertation was originally motivated by a desire to understand how EU policies have impacted on the Maltese health system during the first decade of EU membership. The research aim was eventually broadened to include an exploratory analysis of ongoing EU policy developments and their implications for small MS health systems, using Malta as a case study. On 1st May 2004, following a period of pre-accession preparations, Malta became the country with the smallest population to join the EU. During this period, the health sector was not one of the key areas targeted for debate or scrutiny as part of the accession process.(54) Assessments on the experience of the first years of EU membership do not make reference to the health sector.(55-57) However, life expectancy in Malta improved markedly during the first decade of EU membership.(58) A number of legislative and administrative reforms were carried out and several important public

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health strategies were developed.(59) Whilst Malta’s EU membership has generally been evaluated in positive terms it is not known how EU membership actually impacted on the Maltese health system and whether the ongoing policy developments at EU level are of benefit to the domestic health system or to the contrary, whether they generate an unnecessary burden. (55,57)

The researcher’s work as senior civil servant in the Ministry of Health in Malta provided exposure to both the high-level policy processes in Brussels and operational health system issues of immediate relevance to patients and clinicians on a daily basis. This is a privilege and burden unique to those who work in a small state setting. The tension between the growing interdependence of health systems within the EU and the reluctance, if not outright resistance, for the EU institutions to assume a greater role in policy-making in the area of health systems further motivated the researcher to explore the role of the EU in shaping domestic health systems.

Initial familiarisation with the existent literature uncovered a gap around the role played by the EU in shaping policy developments in health systems of small states. Whilst the small states literature has delved into behaviour of small states within the EU and has examined issues around foreign policy, security and economic policy, no studies regarding small state health systems and the EU were traced.(60-64) The primary scope therefore became that of researching lessons learned from the Maltese experience which would be of interest to other small states within the EU. Furthermore, the current manner in which health policy within the EU is developing and the behaviour of European level stakeholders in shaping these developments create a need to explore the politics of European integration in the area of health. The ongoing struggles taking place at European level between the European Commission, which is sometimes portrayed viewed as an institution seeking to broaden the health mandate, the European Court of Justice appearing to uphold patients’ rights and MS representatives seeking to defend the sovereignty of their health care systems, often seemed distant and far removed from the daily issues crowding the health system agenda at national level. As a senior public officer in a small state, the researcher was in the unique position to concurrently experience local health system issues and European health policy development. It was therefore felt that an analysis of EU health policy development from a small MS perspective would contribute towards an understanding of the desired nature of future European health policy as perceived from the lens of a small state. This experience led to the formulation of the central research aim for this dissertation, namely:

“To explore the influence of EU policy on domestic health systems from a small MS perspective”

The implications from the findings of this dissertation are expected to be of wider relevance to the further development of health policy at EU level as well as being of interest to other small states in the EU.



CENTRAL RESEARCH AIM

Following the EU enlargements of 1995 and 2004, there has been a renewed interest in research on small states in Europe.(41,61) Given the lack of research identified in the area of health policy and small states, specifically European health policy, the overall purpose of this dissertation is therefore to analyse the mechanisms through which the EU exerts its influence on a small Member State as well as to explore the opportunities and challenges that arise for small states through the ongoing policy integration occurring at EU level. In this sense, the dissertation has the ambitious objective of going beyond a positivist perspective in that it seeks to explain “how” decisions at EU level affect the domestic health system, in order to shed light on the normative element of European developments in health policy. More simply, it explores whether the current initiatives characterising European integration of the health sector are “good” or “bad” for small state health systems.

Given the overall research aim, the following research questions are set out: 1. What are the key challenges facing health systems in small EU Member States and

which are the main characteristics of their health system reform processes?This research question is important to identify specificities regarding health systems in small states. The objective is to synthesise the literature on health systems in small EU Member States in order to elucidate common challenges and reform characteristics. It also serves to indicate the potential transferability of findings from the case study on the Maltese health care system to other small EU Member States.

2. What are the principal reforms undertaken in recent years by the Maltese health system and which are the key challenges it is currently facing?

This research question focuses on understanding the context within which the empirical evidence for this dissertation is gathered. Since this dissertation partly uses case-study methodology, a detailed description of the context is an inherent part of the research method for such an approach.(65) It also serves to ground the empirical findings into a real health system context.

3. HowistheEUperceivedtoaffectsmallhealthsystemsatthedomesticlevel?This research question is addressed through the perspective of domestic stakeholders in the Maltese health system. An exploratory analysis of the manner in which the EU affects small health systems is carried out using the Maltese health system as a case study. An important aspect of this research focus is to understand whether EU influence is welcomed or resisted by domestic stakeholders.

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4. How is EU legislation pertaining to health systems implemented in a small state?Through this research question, the dissertation focusses on the dynamics that occur between the European and domestic interface in the implementation of EU legislation. The approach taken is that of detailed analysis of the implementation of an EU directive.

5. How is health policy developing at EU level and what are the implications for health systems?

An analysis of selected important emerging policy initiatives at EU level is carried out in order to describe the way in which new health policies are being driven and constructed at EU level and to identify possible implications for domestic health systems.

6. How can future developments in EU health policy be of added value to small MS health systems?

This research question is normatively framed and seeks to bring together the evidence generated from the various sub-studies in this dissertation to provide appropriate recommendations for EU health policy development from a small health system perspective.

THEORETICAL FRAMEWORK

Health Policy and Systems ResearchThe title of this dissertation, “Europeanisation of health systems: A small state perspective”, places the health system as the primary research focus.(66) The research process is therefore framed within a health policy and health systems research perspective, where the object of interest is the health system and its constituent parts rather than the legal or political system. Health policy and systems research (HPSR) is defined by the Alliance for Health Policy and Systems Research as a field that seeks “to understand and improve how societies organize themselves in achieving collective health goals, and how different actors interact in the policy and implementation processes to contribute to policy outcomes”.(67) In this dissertation, the organisation of societies is explored at the interface between the EU and the national health system levels. The framework utilised for the constituent parts of the health system is that by the WHO. It is composed of six main building blocks for health systems: governance, information, financing, service delivery, human resources, medicines and technologies.(68) This framework has been further modified to place people as central actors driving the system and influencing the key building blocks themselves as illustrated in Figure 1.1. The emphasis on people is of particular relevance for this dissertation since the definition that is used for a ‘small state’ is that based on population size.



Figure 1.1 - Health System Framework (69)

Health policy and systems research is an inter-disciplinary field and the choice of disciplines being used depends on the nature of the research question being addressed.(67) For the scope and purpose of this dissertation, the “Europeanisation” approach from the field of European studies and the theme of vulnerability and resilience from the area of small states studies have been used to develop the conceptual framework for this dissertation.(70)

THE ‘EUROPEANISATION’ FRAMEWORK

An interest in examining the empirical effects of European institutions and values, or more specifically the domestic impact of European integration, led to the coining of the term “Europeanisation” to describe the effects of domestic change brought about as a result of policy change at the European level.(71) Europeanisation has been intimately associated with the EU although this notion has been challenged with some specifically preferring to use the term EU-ization when referring to the European Union.(72) In this dissertation the term “Europeanisation” will be used to refer to the European Union. Exadaktylos and Radaelli propose that Europeanisation – here with a focus on the EU, – may be construed using different approaches.(73) A first approach is that of broad strategies or projects such as Europe 2020, the Lisbon Agenda or the European Semester providing examples of policy integration at the European level. A second approach is one where the objective of research would normally be to assess the degree of Europeanisation

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by comparing for example, different health systems in different countries or different policy domains. Alternatively, Europeanisation can be conceived as an ongoing process of change in public policy, politics or polity. This dissertation selects the classic definition of Europeanisation by Radaelli as a starting point in which Europeanisation is described as “processes of construction, diffusion and institutionalisation of formal and informal rules, procedures, policy paradigms, styles, ‘ways of doing things’, and shared beliefs and norms which are first defined and consolidated in the EU policy process and then incorporated in the logic of domestic discourse, political structures and public policies”.(74)

This conceptualisation offers a convincing framework for this study. Firstly, it is deemed suitable for a study on health systems since it has the virtue of going beyond formal rules and legislation, which in terms of health systems at EU level, are as yet limited, to incorporate various other mechanisms that can exert an influence on health systems.(20) Secondly it combines two distinct processes of Europeanisation that are both within the scope of this dissertation;

a) Europeanisation of health policy through European integration at the level of the EU

b) Europeanisation as a process occurring at the interface between the EU and national health systems.

Europeanisation of health systems at EU level This refers to the process of elaboration of policy in the pursuit of European integration at EU level referred to in the definition of Europeanisation as “…defined and consolidated in the EU policy process….” The issues of interest are both descriptive (how this policy is evolving at present) as well as normative (how it should evolve in future). This aspect of Europeanisation is explored in the dissertation through the proposal put forward by Greer. EU health policy is considered to be developing through three parallel strands of activity nicknamed policy, markets and austerity.(75) Greer describes health policy as being driven through the core public health activities most of which are directed towards “spending small sums of money to promote European networks that connect people and organisations, put items on the agenda for the future and sometimes produce research”. Activities in the areas of communicable disease control, cancer, health information and health technology assessment amongst others fall into this category. The internal market is viewed as the oldest and most powerful driver for health policy with respect to legislation on free movement of goods and persons. Greer argues that the application of internal market law to health care services with the elaboration of the patients’ rights and cross-border care directive was practically inevitable but questions the real potential of this legislation to bring about liberalisation and improvements to patient care. The



face of austerity is attributed to the new regime of fiscal and economic governance, also known as the European Semester through which MS policies and budgets, including those pertaining to the health sector, are under continuous review.(23,76)

Europeanisation of health systems as a process of domestic change The second element of the definition refers to the manner in which the policy developments at EU level are incorporated within the national health system. Studies exploring how European integration, which is pursued through the development of institutions, rules and governance frameworks at EU level, impacts on domestic systems were initially characterised by the top-down approach where the EU is seen as the independent variable and domestic reform as the outcome.(73) The logic of degree of Europeanisation as a consequence of “goodness of fit” predicts that a low degree of misfit would result in limited changes to policies, processes and institutions resulting in absorption. A larger degree of misfit would create higher pressures for and would bring about accommodation through relatively large changes to domestic structures and processes but changes which do not alter their essential characteristics. On the other hand a substantial degree of misfit could act as a positive force for change resulting in transformation. However it could equally result in inertia with large resistance to change such that no change takes place or outright retrenchment where structures and processes actually regress creating a larger gap between the EU policy and domestic status.(71,77-78) Change may be brought about through a redistribution of political resources.(73) Financial incentives and sanctions are also types of stimuli used to affect domestic behaviour. This is facilitated in a situation where veto players are inexistent and institutions are supportive. It is therefore expected that the type of European stimulus being applied and the degree of domestic misfit will affect the nature of the domestic impact seen. This framework is attractive in understanding the domestic response where misfit is easily identifiable and measurable, such as in cases of transposition of legislation. In the health sector positive integration through the application of standards (food, blood tissues and cells) and negative integration through the removal of barriers (mutual recognition – medicines, professions, free movement of patients) can provide good examples for the application of this model.

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Criticisms of the top-down approach to EuropeanisationThe top-down adaptation pressure model centring upon ‘goodness of fit’ is however of little explanatory value where one cannot really speak of misfit as the condition for change and empirically has not been found to explain differential implementation of directives.(79). This is expected to be of relevance to health systems since facilitated coordination is an important approach to European level integration (Open Method of Coordination, learning, benchmarking) in health.(22) In these circumstances, the social constructivist variant of adaptation pressure which views change as emerging through the result of socialisation and social learning may be a more appropriate model to consider.(78,80) The top-down approaches have also been criticised for ignoring the usage of the EU by domestic actors at national level as well as for their unidirectional approach which fails to take into sufficient account the strategies of domestic actors to ‘upload’ their preferences to further shape the development of European policy at the EU level.(81) A further important criticism of the top-down models is that they tend to find Europeanisation even where it does not exist because of an a priori bias.(73) It has therefore been suggested that studies seeking to explore the impact of the EU at a domestic level achieve a better design when taking into consideration a bottom-up approach and researching the manner in which domestic actors encounter the EU, over a period of time.(82)

THE SMALL STATE PERSPECTIVE

According to Thorhallsson and Wivel, the value of the small state perspective in the study of European integration processes is that it provides an opportunity to “rethink the theoretical and practical implications of the integration processes” and thereby allows the debate of the future role of the EU in certain policy areas to move beyond the traditional categories.(61) The size of a country can be measured in terms of its population, land area or gross domestic product.(83-84) Population is a commonly used parameter but there is no general acceptance as to what in actual fact constitutes a small state. The World Health Organisation in the European region includes in its small countries network, countries with a population of less than one million while the Commonwealth Secretariat takes a cut-off point of 1.5 million population in its work on small states.(85-86) In this dissertation, the empirical setting for the research is Malta, an island with a population of 420,000 and the smallest Member State of the EU. There can therefore be no doubt that Malta exhibits the features, assets and limitations associated with small states.(55)

Studies from the discipline of economics have focussed on the concept that small states exhibit a series of inherent vulnerabilities and that their performance at the global level is a result of their success in building resilience through effective leadership, good



governance and the pursuit of appropriate policies. (87-88) In this dissertation, the concept of resilience-building to counteract the effects of a small domestic market is applied to health systems since these are increasingly defined as services subject to economic and market rules at EU level. The features associated with small state specificities found in markets include small population, inability to benefit from economies of scale, dominant market players and lack of regulatory capacity.(89) Some small states tend to seek shelter in regional organisations as a means of building resilience and overcoming vulnerability.(55,90). Studies on the behaviour of small states within the EU have shown that these tend to build alliances with larger states and hold the Commission as a key ally.(41) It has also been shown that new small Member States face greater challenges in adapting to EU requirements.(42)

There are however few generic studies on the Europeanisation experience of small states other than the specific experience of the Scandinavian countries (often considered as small states with the EU context) which may not necessarily be generalizable to other regions in Europe.(56) A recent study on the Europeanisation experience of the Maltese public sector concluded that Malta tends to defy the Mediterranean stereotype when it comes to implementation but that compliance is often superficial, raising doubts on the transformative nature of the Europeanisation experience. In addition, it was concluded that only those parts of the administration that are heavily affected by EU policy such as agriculture, customs and environment that really underwent significant change.(56) This study also showed how civil servants in small states are more likely to be drawn into EU Affairs because some element of their wide responsibilities will have a European dimension, a phenomenon also seen in the Nordic states.(91) This exposure may generate a class of norm entrepreneurs who may facilitate Europeanisation. Alternatively it may trigger resistance to Europeanisation associated with the added burden that accompanies EU membership. Norm entrepreneurs in the form of epistemic and advocacy communities are key intermediate actors in the Europeanisation process and therefore their stance with regards to the EU is of considerable importance in shaping outcomes.(92)

Drawing upon agency-based organisational theory, small states are more likely to lack capacity and highly developed institutions.(60) This leads to the hypothesis that a lower degree of resistance to European integration would be encountered in small states than would be expected in situations where national institutions feel threatened by the possible transfer of power to European levels. Small states have been reported to be more likely to respond by actively seeking shelter in new European institutions using the European Union to enlarge their capacity or adopting EU institutional solutions to increase their legitimacy.(55,64,93) On the other hand, the absence of established institutions at national level can be equated with a lack of policy and administrative capacity, which in itself may trigger resistance to further Europeanisation due to perceived inability to cope with

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additional administrative burden. Studies of Europeanisation outside the EU found that limited statehood could be linked to a lower likelihood of sustainable institutional change and transformation of domestic practices.(94) Thus, the institutional and administrative capacity of states plays an important role in mediating the transformative power of the EU.(95)

CONCEPTUAL FRAMEWORK

The sub-studies that are presented in Chapters 2-7 and the discussion in Chapter 8 have been conceptualised and developed by drawing upon the frameworks and literature from health systems, Europeanisation and small state studies. Figure 1.2 shows how the different disciplines have informed the creation of a conceptual framework that has been proposed to underpin the research process. Europeanisation of health systems is viewed as an ongoing process. While the formal effects of this ongoing Europeanisation process are seen in terms of tangible outcomes such as legislation, institutions, projects, policies and services, the informal effects of Europeanisation pertain to the way the policy making process and people who are at the heart of the health system are shaped and influenced by developments at EU level. Furthermore Europeanisation is conceptualised as a two-way process where domestic health system actors also strive to shape European policy to take into account small states’ needs and aspirations and to use the EU to further their own objectives. Europeanisation of health systems can thus be depicted as taking place at EU level through three strands of activity namely, policy, internal market and economic governance, in line with the three faces described by Greer.(75) European policy integration in these areas is influenced by events occurring in the general European and global context. The EU through these three strands of activity is believed to exert adaptation pressure, through a variety of mechanisms, on the different components of the domestic health system. The domestic health system, depicted according to the six key domains described earlier above, operates within the policy environment that characterises a small state. Domestic actors within the health systems respond to the pressure exerted by EU policy developments but they also cultivate usages of the EU to further their own domestic objectives as well as attempting to influence future EU policy developments. The diagrammatic representation of the relationship between the EU and domestic health systems elaborated as the framework underpinning the research in this dissertation depicted in Figure 1 2, builds upon the explanatory framework described by Radaelli.(74) This conceptual framework acts as a reference point for the empirical work undertaken in the sub-studies and for the overall analysis in the discussion chapter. This dissertation consequently pertains to different disciplines and has acquired an inter-disciplinary dimension as it travelled through public health, health systems, political



science, European studies and small states studies in order to assemble a coherent body of knowledge that addresses the central research aim.

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acquired an inter-disciplinary dimension as it travelled through public health, health systems,

political science, European studies and small states studies in order to assemble a coherent body of

knowledge that addresses the central research aim.

Study design

Since the research questions are intended to analyse complex policy processes and

interaction between actors and institutions, a qualitative approach was deemed the most appropriate

research approach to answer the questions posed in this dissertation.(96) The dissertation presents a

series of papers utilising several research methods including literature review, documentary

analysis, empirical data collection using semi-structured interviews and quantitative data analysis.

Measures were taken to ensure quality in all steps of the research process.(97) A reflexive stance

was taken at the outset with a constant search for counterfactual arguments to challenge the

emerging findings. Peer review through presentation of interim findings at conferences and journal

clubs at local and European level as well as through the publication process aided to enhance the

quality of the individual papers.

A narrative literature review was carried out to identify and synthesise existing literature on

health system reform in small states. This review highlights challenges of health systems in small

states, enabling a first-ever attempt being made to describe some small state health system

European Union Policy

Pressure

Usage

Public health policy

Internal Market

Economic governance

Domestic Health System

Governance Information Financing Service Delivery Human Resources Medicines & Technologies

Small state Context

Euro

pean

and

Glo

bal C

onte

xt

Figure 1.2 Conceptual Framework: Europeanisation of a small state health system Figure 1.2 - Conceptual Framework: Europeanisation of a small state health system

Study designSince the research questions are intended to analyse complex policy processes and interaction between actors and institutions, a qualitative approach was deemed the most appropriate research approach to answer the questions posed in this dissertation.(96) The dissertation presents a series of papers utilising several research methods including literature review, documentary analysis, empirical data collection using semi-structured interviews and quantitative data analysis. Measures were taken to ensure quality in all steps of the research process.(97) A reflexive stance was taken at the outset with a constant search for counterfactual arguments to challenge the emerging findings. Peer review through presentation of interim findings at conferences and journal clubs at local and European level as well as through the publication process aided to enhance the quality of the individual papers.

A narrative literature review was carried out to identify and synthesise existing literature on health system reform in small states. This review highlights challenges of health systems in small states, enabling a first-ever attempt being made to describe some small state health system specificities. It also demonstrated the scarcity of literature on health systems in small EU Member States, in particular the absence of studies investigating the impact of EU policy on small state health systems. This gap in the literature confirmed the importance of researching the impact of EU policies on a small state health system. Findings from this literature review which are presented in chapter 2 were useful to keep the small state perspective at the forefront of the ensuing sub-studies.

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Chapters 3, 4 and 5 taken together constitute a qualitative case-study of the Europeanisation experience of the Maltese health system.(65) When presenting a case study, an understanding of the context is extremely important.(98) This was implemented through the preparation of a technical policy report on the Maltese health system according to the HiT template of the European Observatory on Health Systems and Policies for Health Care System in Transition.(99) Three chapters from the policy report have been brought together and included as the background context to the Maltese health system for this dissertation. They are intended to provide an introduction to Malta and the key features of the health system for readers who may not be familiar with the country. A summary of the principal reforms implemented over the past decade and an overall assessment of the health system are also included. The case study of the Europeanisation of the Maltese health system is built upon a qualitative interview study of 33 domestic stakeholders. Stakeholder analysis is deemed an important research approach in the methods toolkit set out by the Alliance for Health Policy and Systems Research of the World Health Organisation.(100) The data collected has been used in two sub-studies. An inductive analysis of the data was performed to describe the Europeanisation experience of the domestic stakeholders and findings from this analysis are presented in chapter 4. The views of the domestic stakeholders and the facts described in the HiT report, provide a picture of the complex reality which the Maltese health system finds itself in as it seeks to navigate between the pressures and opportunities and presented by the EU and its contextual small state health system specificities. This tension is explored in chapter 5 through an in-depth analysis of the implementation of the patients’ rights and cross-border health care directive using relevant themes extracted from the interviews with domestic stakeholders. It is an example of current health system Europeanisation in a small state setting, triggered by the internal market strand of EU policy. A variety of methods were used to approach the policy analysis of selected current EU developments. The choice of policies for analysis was guided by findings from the interviews carried out for the Maltese case study. In chapter 6 a literature review and documentary analysis are used to explore the potential impact of the EU Joint Procurement Agreement for medical countermeasures.(101) This policy is selected since it is an example from the ‘public health policy’ strand of EU policy that is relevant to health systems. Furthermore it is favourably perceived by domestic stakeholders working in the areas of communicable diseases or medicines. In chapter 7, summative and qualitative content analysis of the Country Specific Recommendations (CSRs) from the European Semester is carried out together with correlational quantitative analysis to determine the association between key variables and the likelihood of obtaining a CSR.(102) This chapter provides an example of a policy initiative emanating from the ‘economic governance’ strand (face of austerity). The interviews conducted with domestic health system stakeholders in Malta



reveal that they attach significant importance to these CSRs and their potential influence on the Maltese health system and this motivated the selection of this policy initiative for analysis.

The six studies complement one another. Three studies are situated within the Maltese health system (chapters 3,4,5) whilst three other studies are situated at the European level (chapters 2,6,7). Taken altogether, the studies provide important evidence on the Europeanisation of health systems, above all as seen from a small state perspective.

OUTLINE OF THE DISSERTATION

This section outlines how the set of six research articles address each of the research questions described earlier in this chapter. Chapter 2 presents the results of a narrative literature review on health systems in small EU Member States. Through this literature review, common challenges and characteristics of health system reform in small states are identified thereby addressing the first research question. Chapter 3 presents the contextual background to the Malta case study and addresses the second research question by describing the principal health system reforms and key challenges. This chapter sets the scene for chapters 4 and 5 which are also based upon the Maltese health system. Chapter 4 presents empirical evidence obtained through inductive analysis from the qualitative case study on the Maltese health system. The perceptions of Maltese health system elite stakeholders regarding the influence of the EU in within the health system are explored to address the third research question. The case study on the implementation of the patients’ rights and cross border directive in the Maltese health care system, described in chapter 5, provides an example of legislative implementation in a small state health system and addresses the fourth research question. Chapters 6 and 7 present an analysis of two important policy initiatives developing at EU level with significant potential implications for health systems, namely; the Joint Procurement Agreement on medicines and medical counter measures to combat cross-border health threats and Country Specific Recommendations (CSR) on health care systems issued through the European Semester respectively. These two chapters address the fifth research question. In chapter 8, a general discussion combining findings from the sub-studies is presented. As a result of obtaining a better understanding of the process of European integration in the area of health and the implications of this process for a small EU Member State, as is Malta, the final research question is addressed and recommendations for further research and development of health policy at European level are provided.

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CHAPTER 2Policy Challenges and Reforms in Small

EU Member State Health Systems:

A Narrative Literature Review

Azzopardi-Muscat N., Funk T., Buttigieg S., Grech K, Brand H. Policy challenges and reforms in small EU Member States health systems: A narrative

literature review; European Journal of Public Health DOI:10.1093/eurpub/ckw091

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ABSTRACT

Background: The EU directive on patients’ rights and cross-border care is of particular interest to small states as it reinforces the concept of health system cooperation. An analysis of the challenges faced by small states, as well as a deep evaluation of their health system reform characteristics is therefore timely and justified. This paper identifies areas in which EU level cooperation may bring added value to these countries’ health systems.

Method: Literature search is based primarily on PUBMED and is limited to English-language papers published between January 2000 and September 2014. Results of 76 original research papers appearing in peer-reviewed journals are summarised in a literature map and narrative review.

Results: Primary care, health workforce and medicines emerge as the salient themes in the review. Lack of capacity and small market size are found to be the frequently encountered challenges in governance and delivery of services. These constraints appear to also impinge on the ability of small states to effectively implement health system reforms. The EU appears to play a marginal role in supporting small state health systems, albeit the stimulus for reform associated with EU accession.

Conclusions: Small states face common health system challenges which could potentially be addressed through enhanced health system cooperation at EU level. The lessons learned from research on small states may be of relevance to health systems organized at regional level in larger European states.

Key wordsHealth policy, health care reform, European Union, small states


Policy Challenges and Reforms in Small EU Member State | 31

INTRODUCTION

In the aftermath of the financial and economic crisis, there is renewed interest in small state studies.(1-4) To date literature on small states has largely focussed on international relations and economic concerns.(5-7) Whereas some authors contend that small states perform relatively well in terms of economic growth and that small size plays a less significant role than generally ascribed in determining outcomes,(8) others emphasise the inherent vulnerabilities that characterise small states. Vulnerabilities associated with small size and geographical isolation (5,9) (in the case of islands) include lack of economies of scale, limited capacity and significant exposure to external economic shocks.(1,10) Whilst there may be disagreement about the extent to which small size constitutes a disadvantage in the global economy, small state scholars generally agree that good governance and social capital are particularly important for building resilience in small states.(9, 11-12) The European Union (EU) has been described as an important source of shelter and support for small states through its ability to enlarge their capacity for action.(1,6,13-17)

Despite the growth of health systems as an economic sector, literature on small states has not yet addressed the specific challenges that health systems in small states encounter. Specifically, the role of the EU as a potential ‘shelter provider’ for health systems in small states does not appear to have received much attention.(1) This is possibly due to the fact that the Treaty emphasises Member State (MS) competence for health systems as well as evidence that small states seek support for their health systems through bilateral alliances with larger states.(18-21) However the EU directive on patients’ rights and cross-border care is highly relevant from a small state perspective. Patient mobility consistently emerges as being more important to citizens in small states.(22-24) Secondly, the directive provides an important legal basis for health systems cooperation through the development of European Reference Networks, networks for Health Technology Assessment and e health networks.(25-28) However, in order that appropriate health policy responses which provide clear added value from a small state perspective be made at EU level, it is necessary to have information on specific challenges facing health systems in small states. Mapping of literature on small state health systems can provide vital information for EU level health policy analysis. This paper therefore includes a narrative literature review, which explores the following questions: What are the challenges experienced by health systems in small EU Member States? What are the characteristic features of health system reforms in small EU MS and what role does the EU play in influencing small state health systems?

There is ongoing debate as to how one should define a small state,(2,29-32) but small state scholars generally agree that the ‘small state’ concept is relative and its utility lies

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mainly as a “comparative focussing device”.(30) In this study, we define a small EU state as having a population under three million and therefore include Cyprus, Estonia, Latvia, Lithuania, Luxembourg, Malta and Slovenia in our scope.1 Comparative data for these countries is presented in Table 2.1.

Table 2.1 - Characteristics of small states included in this literature reviewCyprus Estonia Latvia Lithuania Luxembourg Malta Slovenia

Population(2013)

1,141,166 1,324,612 2,013,385 2,956,121 543,202 423,282 2,060,484

GDP per capita in US$(2013)

25,249 18,478 15,375 15,538 111,162 22,780 22,729

Life Expectancy(2012)

80 years 76 years 74 years 74 years 81 years 81 years 80 years

Total Health Expenditure % GDP (2011)

7.3 % 5.9% 6.0% 6.7% 6.9 % 9.1 % 8.8%

METHODS

Combinations of the following MeSH terms: “health system”, “health facilities”, “health manpower”, “policy”, “health planning”, “delivery of health care”, “health care reform” with any one of the following terms: “Malta”, “Cyprus”, “Luxembourg”, “Lithuania”, “Latvia”, “Estonia”, “Slovenia”, were searched in PUBMED. The searches were carried out during September 2014. Articles were restricted to those published between 2000 and 2014 in order to incorporate the immediate EU pre-accession period for those MS that joined in 2004 while keeping the search feasible. Articles had to be published in the English language and have an abstract available for review in order to eliminate letters, commentaries and editorials. Searches carried out in Ministry of Health websites of the MS under study and other websites for example, the European Observatory on Health Systems and Policies, yielded two additional relevant articles. The publication abstracts were screened by two researchers. A third senior researcher screened dubious abstracts. If the relevance of the publication was uncertain, the full-text was reviewed. In considering the relevance of publications, the following criteria were applied: - the

1 The Forum of Small States (FOSS) within the United Nations comprises countries with a population under ten million. The World Bank and the Commonwealth define their cut off point at countries with a population under 1.5 million. The recently established WHO network for small countries takes a population under one million as its cut off point.



publication had to be based on the analysis of primary or secondary data including at least one of the countries of interest and address at least one of the research questions. We used the technique of interpretive synthesis, reading and re-reading the primary sources and using narrative to summarise the key findings.(33) The evidence was categorised in the form of tables and is reported in line with the research questions. Each article was independently analysed by at least two researchers from the team. The literature was mapped drawing upon two commonly used frameworks for health systems.(34-35) A consensus meeting was held to discuss and agree upon the key findings.

RESULTS

Five hundred and seventy-seven records were initially identified, of which 76 finally met the relevance criteria as indicated in Figure 2.1. The commonest reasons for exclusion were that the publications did not address at least one of the research questions or that none of the countries of interest were actually studied.

40

Figure 2.1 - Flow chart of the publication selection process

Characteristics of the publications

Twenty-three publications were multi-country publications featuring at least one of the

countries included in this review. There is considerable variation in research output between

countries; Lithuania nineteen publications, Cyprus ten, Estonia ten, Slovenia eight, Malta three,

Latvia two and Luxembourg one publication. More than half (52%) of the publications analysed

were published in the last five years of the fifteen-year period under review. This is indicative of

increased research output from these countries in recent years. The full list of articles included in

the review is available as supplementary material.(Annex A) Forty-one publications are policy

analyses based on existing data and secondary data analysis (with the exception of three studies that

also included primary data collection). Twenty-six publications collected their own data through

surveys. The remaining publications were four economic analyses, two case studies, one

bibliometric analysis, one observational study and one experimental intervention.

Figure 2.1 - Flow chart of the publication selection process

Characteristics of the publicationsTwenty-three publications were multi-country publications featuring at least one of the countries included in this review. There is considerable variation in research output

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between countries; Lithuania nineteen publications, Cyprus ten, Estonia ten, Slovenia eight, Malta three, Latvia two and Luxembourg one publication. More than half (52%) of the publications analysed were published in the last five years of the fifteen-year period under review. This is indicative of increased research output from these countries in recent years. The full list of articles included in the review is available as supplementary material.(Annex A) Forty-one publications are policy analyses based on existing data and secondary data analysis (with the exception of three studies that also included primary data collection). Twenty-six publications collected their own data through surveys. The remaining publications were four economic analyses, two case studies, one bibliometric analysis, one observational study and one experimental intervention.

Mapping of the literatureThe literature map shown in Figure 2.2 classifies the publications reviewed according to research topic and illustrates the number of publications on a particular topic. Nine publications are generic health system overviews. The most commonly researched topics are primary care with eleven publications, followed by health workforce eight and medicines seven publication. It is relevant to note that some publications are related to several aspects of the EU directive on patients’ rights and cross-border health care, namely cross-border health care organisation four publications, e health three publications and health technology assessment also three publications. Some topics appear uniquely for specific countries, for example dental health for Cyprus and reproductive health for the Baltics.



General Health System Overview Bankauskaite, V., & O'Connor, J. S. (2008); Albreht, T., et. al. (2009); Albreht, T., & Klazinga, N. (2009) Mitenbergs, U.,et. al. (2012); Theodorou, M., et. al. (2012)

Lai, T., et. al. (2013); Murauskiene, L., et. al. (2013); Azzopardi Muscat, N., et. al. (2014); Fi, N., et. al. (2014)

Health system inputs Service Delivery Governance

Health Financing Health Insurance Markota, M., & Albreht, T. (2001)

Cylus, J., et. al. (2013) Out of pocket payment Habicht, J.,et. al. (2006) Danyliv, A., et. al. (2014)

Health Workforce Albreht, T., & Klazinga, N. (2002) Lovkyte, L., et. al. (2003) Kairys, J., et. al. (2008) Filej, B., et. al. (2009) Buivydiene, J. et. al. (2010) Grech, V.,et. al. (2011) Starkiene, L., et. al. (2013) Hadjigeorgiou, E., & Coxon, K. (2014).

Medicines Merkur, S., & Mossialos, E. (2007) Volmer, D.,et. al. (2008) Theodorou, M., et. al. (2009) Garuoliene, K., et. al. (2011) Vogler, S., et. al. (2011)

Lionis, C., et. al. (2014)

Petrou, P. (2014)

Health technology assessment (HTA) Danguole, J. (2009)

Vanagas, G., & Padaiga, Z. (2012)

Jankauskiene, D., & Petronyte, G. (2013)

E health Duplaga, M. (2007) De Lusignan, S., et. a. (2013) Lluch, M., & Abadie, F. (2013)

Public health Albreht, T., & Klazinga, N. S. (2008) O'Connor, J. S., & Bankauskaite, V. (2008) Alcohol policy Paukste, E.,et. al. (2013)

Quality and Standards Bero, L. A., et.al. (2013) Potocnik, M. (2005) de Beaufort, C., et. al (2012) Jędrzejczak, J.,et. al. (2013)

Research Delnoij, D. M., & Groenewegen, P. P. (2007) Knabe, A., & McCarthy, M. (2012) McCarthy, M. (2012)

Ethics Virbalis, R. (2002) Bankauskaite, V., & Jakusovaite, I. (2006) Lazarus, J. V., et. al (2008)

Health System Performance Assessment (HSPA) Polluste, K.,et. al. (2006) Jeremic, V., et. al. (2012) Lunevicius, R., & Rahman, M. H. (2012) Luengo-Fernandez, R. et. al. (2013)

Primary health care Lember, M. (2002) Polluste, K., et. al. (2004) Albreht, T. et.al. (2006) Atun, R. et. al. (2006) Liseckiene, I., et. al. (2007) Liseckiene, I.et. al. (2012) Oleszczyk, M.,et. al. (2012) Groenewegen, P. P., et. al. (2013) Kringos, D., et. al. (2013) Polluste, K. et. al. (2013) Zachariadou, T.,et. al. (2013)

Cancer Nicula, F. A., et. al. (2009) Charalambous, A., et.al. (2014)

Mental health Polubinskaya, S. V. (2000)

Jaruseviciene, L., et. al. (2014)

Reproductive health Kalediene, R., & Nadisauskiene, R. (2002) Lazarus, J.,et. al (2004)

Dental health Charalambous, C., et. al. (2013) Charalambous, C., & Theodorou, M. (2013)

Tuberculosis Pehme, L., et. al (2007)

Cross-border health care Köhler, F., et. al. (2005), Olsena, S. (2014), Saliba, V.,et. al. (2014), Schwebag, M. (2014)

Geriatric care Lesauskaite, V. et. al. (2006)

Figure 2.2 - Literature Map – Health Systems in Small Research in European States

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Challenges Lack of capacity is an issue that gives rise to several common challenges. Health services research is comparatively weak in small countries with some small states additionally reporting a lack of national guidelines, quality assurance systems and accreditation programmes.(36-38) Other studies report inadequacies in national guidelines in areas of highly specialised care, for example paediatric diabetes or epilepsy.(39-40) Healthcare providers tend to follow standards and guidelines fixed at international levels, or by foreign bodies, frequently without adaptation at a national level.(41) This gap arises primarily from limited technical and human capacity.(42) An example of this lack of capacity is evidenced by the need to prioritise health technologies for assessment due to the inability to undertake several HTA’s simultaneously.(43) Furthermore, another emerging challenge is the limited capacity to provide highly specialised treatments for rare diseases. Small countries need to come to a decision as to whether such diseases are treated within the country (self-sufficient model) or if these patients should be treated abroad. The decision largely depends on the respective overall national plans for health care, the available funds and the number of patients. Successful bilateral cooperation programmes, for example the generic agreement between Malta and the UK,(21) or the programme between Germany and Estonia for congenital heart disease,(18) can lead to the development of a modified self-sufficiency model. Cyprus and Malta exhibit specific problems arising out of their split public and private service provision. This is especially true for primary care, which is classified as weak in both countries,(44) and other ambulatory services such as dental care in Cyprus.(45-46) Weak primary care systems are moreover associated with irrational prescription of medicines and a high level of out of pocket payments.(47-50) There is also some evidence that the medical profession is a strong veto player in small health systems where decision-making often lacks the active participation of patients and the public.(51-52) For example, in Slovenia, health care management is largely the domain of the medical profession,(53) whilst in Cyprus physician dominance is reportedly associated with medicalisation of childbirth and a high rate of Caesarean sections.(54) Outward mobility of health care professionals is another salient policy problem for certain small states. This was further exacerbated by EU membership.(49,55) Evidence regarding pharmaceutical pricing is mixed. Whilst a study in Cyprus showed high prices of medicines,(56) another study focussing on generic medicines in Lithuania showed the possibility to obtain relatively good prices despite the small market size.(57) Measures affecting the pharmaceutical industry during the financial crisis raise concerns about medicines availability, which has been an issue, especially for small national markets in European countries.(58) The power asymmetry faced by small states in dealing with multinational industries is not limited to the pharmaceutical industry but is also manifested in other public health



issues. In the case of Lithuania, a series of proposals to restrict alcohol in response to public health consequences of increased consumption were initially implemented but the proposed advertising ban was eventually overturned. This policy U-turn was partly due to pressure from the international alcohol industry.(59)

Health system reformsSuccessful reforms are exemplified by the implementation of primary care reforms and the setting up of an electronic health information system in Estonia. Publications about these reforms highlight the importance of a coordinated approach encompassing legislative change, organisational restructuring, modifications to financing and provider payment systems, creation of incentives to enhance service innovations, investment in human resources,(60) support by civil society,(61-62) efficiency and affordability.(63-64) A positive example of policy implementation comes from Lithuania and describes how the implementation of recommendations of research studies relating to physician emigration from Lithuania attracted the attention of policy-makers, health-care managers, and professional organizations. Appropriate and timely responses were taken including the establishment of human resource monitoring systems. This success is attributed to the proximity of researchers to the policy making community.(65)

Despite the sporadic success in health system reforms in small EU MS, several publications provide examples that indicate a general inertia and difficulty in health system reform implementation. Lack of financial and technical resources, weak inter-sectoral cooperation, strong industry pressure, insufficient separation between policy development and policy execution, lack of leadership and institutional capacity are described as key barriers.(66) For example, in Cyprus, implementation of the health insurance system has been delayed for more than ten years.(48) In Slovenia, although some public health reforms were introduced, these are not described as ‘far reaching’ as the Ministry of Health reportedly sought to avoid radical reform which would have led to open confrontation with powerful medical elite.(67) Another case study dealing with trauma services in Lithuania listed several barriers to health system reform such as lack of political, academic and public will, absence of a national injury policy, no specialized injury research institute, no system of trauma centres, no injury surveillance system as well as the lack of a specialty of Emergency Medicine.(68) Similarly, primary care reform implementation in Malta was resisted by key stakeholders.(49) All three Baltic countries decentralized their health financing systems in the mid-1990s as part of the political post-Soviet transition but later reverted back to a more centralized system of financial administration due to a lack of economies of scale.(69)

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Role played by the European Union (EU)Out of the seven small states considered in this review, six acceded to the EU in 2004. The EU accession process was characterised by a sense of positive expectation although it also brought about certain challenges. For example, EU accession is considered to have created an additional boost for the political transformation process in the Baltic States. Reforms made use of financial support from EU structural funds (2004–2006 and 2007–2013) in relation to implementation of e health strategies in Estonia,(70) while in Slovenia, the obligation to implement the directive on quality and safety of blood (2002/98/CE) provided an opportunity to accelerate implementation of standards to increase the safety of blood transfusion.(71) EU membership also triggered a desire to implement certain norms as exemplified by the development of the specialty of gerontology in Lithuania.(72) More recently in Latvia and Luxembourg, a positive development in patients’ rights legislation and implementation was expected due to obligations associated with the directive (2011/24) on patients’ rights and cross border care.(38,41) In Cyprus, the application for a financial bail-out acted as a stimulus for recommitment to implement health insurance and the Troika recommendation was viewed positively by domestic actors as an opportunity for reform.(48,50) On the other hand, EU membership is also reported to have created certain challenges. In Lithuania relative price reduction of alcohol due to cancellation of import tax, exacerbated public health problems associated with alcohol consumption.(59) In Malta, difficulties in coping with the requirements of the working time directive within the hospital sector led to the need to increase doctors in certain specialities, for example paediatrics, leading to a concern that the overall market would be oversupplied.(73)

Small states continue to entertain expectations from the EU. With regard to cancer screening, there is a perceived need to support coordination between screening centres at European level.(74) Cooperation at EU level on HTA is also perceived as a major factor influencing development of HTA at national level by increasing its overall visibility.(75) In primary care, although EU accession required the creation of family medicine as a specialty, the initial enthusiasm of implementing family medicine has declined with the lack of initiative from the EU to support and sustain primary care development being cited as a key reason.(76)

DISCUSSION

Lack of capacity and small market size emerge as the key challenges for small state health systems. These in turn impact on elements of health system governance, health services delivery and the ability to implement health system reforms effectively. EU accession has undoubtedly provided a much needed incentive for reform in small states. However,



apart from the stimulus for reform associated with EU accession, the EU to date appears to have played a marginal role in supporting small state health systems. Whilst the small states covered in this review have different health system policy reform objectives, stemming from their diverse historical, geographical and economic needs, common challenges and characteristics have been identified. Political ideology and financial crises emerge as the most common reasons for initiation of reforms. Powerful elites, including a patriarchal medical profession, appear to be more important in shaping the course of reform than popular support or civil society. A review of reform experiences in other small countries outside Europe showed that dominant values, institutions and interests also play an important role in shaping outcomes of national health policy.(77) Whilst in terms of effective implementation, small countries are often reported to be in a position to act faster than large nations, (particularly in countries with strong central governments and weak or absent civil society in other cases), it was shown that organized stakeholders with strong veto power thwarted reforms. Findings from our review concur with these observations.

Methodological considerationsWe present a narrative synthesis of health system specificities found in small EU Member States. As our review explores the claims that authors make concerning innovations in research methods, we searched publications from peer-reviewed journals so that authors’ claims were scrutinised by others in the field, indicating that the claims were deemed reasonable. We limited the search to relevant MeSH terms and key words and may have therefore missed articles that were not indexed using the terms we selected. We acknowledge that certain results are based on findings from one or two articles and may have inadvertently assumed that a particular issue is a characteristic of small states when further research is necessary to examine transferability across different small states. Whilst the significant variations between the country health systems that we included in this review detract from their comparability, we have sought to focus on themes that are relevant to the common factor, namely small population size.

ImplicationsOur review indicates that small states face certain common health system challenges, most notably linked to lack of capacity. This lack of capacity also manifests itself in the sparse research on health systems, although it is noted that in the past years the capacity for publication in the field of health systems research in small states appears to have increased. Lack of capacity generally leads small states to adopt modified models of self-sufficiency in areas such as guideline development and provision of highly specialized care. Small states determine what is feasible to be accomplished at national level versus

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relying on technical capacity and resources found in larger countries. We believe there is the potential to address some of these challenges through enhanced health system cooperation at EU level although further research is required. Such initiatives may strengthen health system resilience in small states. As decentralization of responsibility for financing and organization of health systems to the regional level becomes more widespread in Europe, lessons learnt from the social ecology of health systems in small states could also be relevant to health systems in larger states.

CONCLUSIONS

Our review has shown that small states do share some common health system challenges and reform characteristics. There is a notable gap in the literature on the influence of the EU on health system developments and reforms in small states. The high level of power asymmetry that is experienced between the European institutions and small states on the one hand and the benefits that can be reaped from enhanced collaboration on the other hand renders this topic an important priority for research on the future of European health policy.



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Annex A – List of Articles Included in Narrative Review and Literature Map

Albreht, T., Delnoij, D. M., & Klazinga, N. (2006). Changes in primary health care centres over the transition period in Slovenia. Eur J Public Health, 16(3), 238-243. doi: 10.1093/eurpub/cki224

Albreht, T., Turk, E., Toth, M., Celgar, J., Marn, S., Pribakovi´c Brinovec, R., Schäfer, M. Avdeeva O and van Ginneken E (2009). Slovenia: Health system review. Health Syst Transit. 11(3): 1-168.

Albreht, T., & Klazinga, N. (2002). Health manpower planning in Slovenia: a policy analysis of the changes in roles of stakeholders and methodologies. Journal of Health Politics, Policy and Law, 27(6), 1001-1022.

Albreht, T., & Klazinga, N. (2009). Privatisation of health care in Slovenia in the period 1992-2008. Health Policy, 90(2-3), 262-269. doi: 10.1016/j.healthpol.2008.10.007

Albreht, T., & Klazinga, N. S. (2008). Restructuring public health in Slovenia between 1985 and 2006. Int J Public Health, 53(3), 150-159.

Atun, R. A., Menabde, N., Saluvere, K., Jesse, M., & Habicht, J. (2006). Introducing a complex health innovation--primary health care reforms in Estonia (multimethods evaluation). Health Policy, 79(1), 79-91. doi: 10.1016/j.healthpol.2005.12.005

Azzopardi Muscat, N., Calleja, N., Calleja, A., & Cylus, J. (2014). Malta: Health system review. Health Syst Transit, 16(1), 1-97, xiii.

Bankauskaite, V., & Jakusovaite, I. (2006). Dealing with ethical problems in the healthcare system in Lithuania: achievements and challenges. J Med Ethics, 32(10), 584-587. doi: 10.1136/jme.2005.014761

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de Beaufort, C., Vazeou, A., Sumnik, Z., Cinek, O., Hanas, R., Danne, T., . . . Forsander, G. (2012). Harmonize care to optimize outcome in children and adolescents with diabetes mellitus:

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treatment recommendations in Europe. Pediatr Diabetes, 13 Suppl 16, 15-19. doi: 10.1111/j.1399-5448.2012.00908.x

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Kringos, D., Boerma, W., Bourgueil, Y., Cartier, T., Dedeu, T., Hasvold, T., . . . Groenewegen, P. (2013). The strength of primary care in Europe: an international comparative study. Br J Gen Pract, 63(616), e742-750. doi: 10.3399/bjgp13X674422

Lai, T., Habicht, T., Kahur, K., Reinap, M., Kiivet, R., & van Ginneken, E. (2013). Estonia: health system review. Health Syst Transit, 15(6), 1-196.

Lazarus, J., Nadisauskiene, R., & Liljestrand, J. (2004). Observations on reproductive health programs in the Baltic States. International Journal of Gynecology & Obstetrics, 87(3), 277-280.

Lazarus, J. V., Jaruseviciene, L., & Liljestrand, J. (2008). Lithuanian general practitioners’ knowledge of confidentiality laws in adolescent sexual and reproductive healthcare: a cross-sectional study. Scand J Public Health, 36(3), 303-309. doi: 10.1177/1403494808086984

Lember, M. (2002). A policy of introducing a new contract and funding system of general practice in Estonia. The International journal of health planning and management, 17(1), 41-53.

Lesauskaite, V., Macijauskiene, J., & Rader, E. (2006). Challenges and opportunities of health care for the aging community in Lithuania. Gerontology, 52(1), 40-44.

Lionis, C., Petelos, E., Shea, S., Bagiartaki, G., Tsiligianni, I. G., Kamekis, A., . . . Moschandreas, J. (2014). Irrational prescribing of over-the-counter (OTC) medicines in general practice: testing the feasibility of an educational intervention among physicians in five European countries. BMC Fam Pract, 15(1), 34.

Liseckiene, I., Boerma, W. G., Milasauskiene, Z., Valius, L., Miseviciene, I., & Groenewegen, P. P. (2007). Primary care in a post-communist country 10 years later Comparison of service profiles of Lithuanian primary care physicians in 1994 and GPs in 2004. Health Policy, 83(1), 105-113. doi: 10.1016/j.healthpol.2006.11.011

Liseckiene, I., Miseviciene, I., & Dudonis, M. (2012). Organizational changes in the course of the PHC reform in Lithuania from 1994 to 2010. Health Policy, 106(3), 276-283. doi: 10.1016/j.healthpol.2012.03.011

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Markota, M., & Albreht, T. (2001). Slovenian experience on health insurance (re)introduction. Croat Med J, 42(1), 18-23.

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CHAPTER 3Malta: Health System Review

Azzopardi-Muscat N., Calleja N., Calleja A., Cylus J. Malta: Health System Review; Chapters 1, 6 & 7. Health Systems in Transition, 2014, 16(1): Pages 1-7, 69-76, 79-88

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Malta Health System Review | 53

INTRODUCTION TO THE MALTESE HEALTH SYSTEM

The Republic of Malta consists of three main islands, Malta, Gozo and Comino, forming an archipelago in the Mediterranean Sea, and has the highest population density in Europe. Life expectancy has steadily increased over the past 20 years and compares well to the European Union (EU) average. In 2011, life expectancy at birth was 78.4 years for men and 82.6 years for women. Standardized mortality rates for circulatory diseases have decreased over time from 426 per 100 000 in 1990 to 232 per 100 000 in 2011, but are still higher than those of the EU15 (161 per 100 000).

While mortality rates for cancers are also showing a downward trend and compare well with the EU15, this trend is less pronounced than that of circulatory diseases. Survival rates for common types of cancer such as breast cancer are improving but frequently remain below the average found in the EUROCARE (EUROpean CAncer REgistry-based study on survival and CARE of cancer patients) study.

Non-communicable diseases are a major issue. One preventable contributing factor is obesity, which is increasingly prevalent among both adults and children. Strategic policy documents with a strong focus on health promotion and primary prevention, including the Non-communicable Disease Strategy 2010, the National Cancer Plan 2011, the Sexual Health Strategy 2011, the Healthy Weight for Life Strategy 2012, the Tuberculosis Prevention Strategy 2012 and a strategy that seeks to address the needs of people with dementia together with their families and carers as part of a holistic approach were compiled. These strategy documents are generally target-based, while impact assessments are in progress.

Geography and socio-demographyThe Republic of Malta (i.e. the Maltese Islands, unless otherwise stated) consists of three main islands, Malta, Gozo and Comino, forming an archipelago in the Mediterranean Sea with Sicily 93 km to the north, Libya 288 km to the south, Gibraltar 1826 km to the west and Alexandria 1510 km to the east (Fig. 3.1). The climate is warm year-round. The total land area is 316 km² and the population was 416 110 in 2011.(1) At 1300 persons per km² (Table 3.1), the population density is the highest in Europe.

Population growth has slowed from 1.0% per year in 1990 to 0.5% per year in 2010.(2) While the crude death rate has been relatively stable over the past 20 years (7.9 per 1000 persons in 2011) there has been a decline in the fertility rate from 2 births per woman in 1991 to 1.4 in 2010. The crude birth rate was 10.3 per 1000 in 2011.(1)

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Figure 3.1 - Map of Malta

Trends in population/demographic indicators, selected years

Table 3.1 - Trends in population/demographic indicators selected years1980 1990 1995 2000 2005 2010

Total population 325 721 361 908 378 404 391 415 405 006 417 617Population, female (% of total) 51.4 50.8 50.6 50.5 50.4 50.3

Population aged 0–14 (% of total) 24.2 23.5 21.8 20.1 17.4 15.4Population aged 65 and above (% of total) 8.3 10.4 11.0 12.2 13.4 15.2Population aged 80 and above (% of total) 0.9 2.0 2.2 2.4 3.0 3.4

Population growth (average annual growth rate) 1.0 1.0 0.7 0.5 0.6 0.5Population density (people per sq km) 993.8 1 106.6 1 158.8 1 205.7 1 261.0 1 300.0Fertility rate, total (births per woman) 2.0 2.0 1.8 1.7 1.4 1.4

Birth rate, crude (per 1000 people) 17.6 15.2 12.4 11.3 9.6 9.7Death rate, crude (per 1000 people) 10.4 7.7 7.3 7.7 7.8 7.2

Age dependency ratio (population 0–14 & 65+; population 15–64 years)

48.2 51.2 50.3 47.2 44.1 44.5

Percentage of urban population 89.8 90.4 91.0 92.4 93.7 94.7Proportion of single-person households N/A N/A 14.8 N/A 18.9 18.8

School enrolment tertiary (% gross) 2.8 10.5 21.6 20.6 30.7 35.3Sources: (2-4)



The Maltese population is ageing. According to the latest preliminary census report conducted during 2011, the average age has increased from 38.5 in 2005 to 40.5 in 2011. This is mainly attributed to a rise in the number of persons aged 55 and over accompanied by a concurrent decrease in the number of persons under 25 years.(5) Persons aged 65 and over represent 16.3% of the total population compared to 13.7% in 2005. In contrast persons aged 14 and under comprise 14.8% of the population compared to 17.2% in 2005.(5) The old age dependency ratio, which measures the number of older people as a share of those of working age, stood at 17.2% in 1995, 19.9% in 2005 and 23.7% in 2011.(5) Despite the notable increase in the older population, Malta’s population is still relatively young when compared to an average old age dependency ratio of 25.9% across the EU. However, projections depict a totally different scenario with the ratio increasing, and exceeding the EU average, to 31.8% (EU average 31.4%), 36.3% (EU average 34.6%) and 39.2% (EU average 38.3%) for years 2020, 2025 and 2030, respectively.(6)

As of 2005,(7) 93.9% of residents were born in Malta; most others were born in the United Kingdom, Australia or Canada. In 2010 there was an estimated net immigration of 2247 persons, mainly from other EU Member States as well as returning Maltese nationals. While there are few reliable data, from 2005 to 2009, authorities reported an average of 1911 irregular immigrants per year by boat, though only 47 were reported in 2010.(3) Most are from Africa, with a small proportion from Asia.

Both English and Maltese are official languages. The official religion is Roman Catholicism, which is taught in schools. Schooling is compulsory for children aged 5–16 years. Approximately 23.6% of children attend Church schools and 7% attend private schools. There have been significant improvements in post-compulsory school participation rates from around 40% in 2000 to over 70%.(8) Most marriages occur within the Church, however around 33% (in 2010) were civil marriages.(3) Legislation introducing divorce came into effect in October 2011 following the results of a national referendum.

Economic contextMalta’s economy, though small, is highly diversified and exposed to international market forces. Economic development relies heavily on the generation of local investment resources and foreign direct investment. The economy is dependent on manufacturing, tourism and key service sectors including financial, business, information technology and remote gaming. In 2012, real gross domestic product (GDP) grew by 0.8%, compared with a 0.6% contraction in the euro area and according to the Ministry for Finance forecast real GDP growth is accelerating to 1.4% in 2013 and 1.6% in 2014. Unemployment is projected to remain low and stable, decreasing from 6.5% in 2012 to 6.3% in 2013 and 6.3% in 2014.(9)

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In 2012, the deficit-to-GDP ratio stood at 3.3% exceeding the 2.2% target for that year and above the 3% of GDP maximum stipulated by the Excessive Deficit Procedure of the EU Stability and Growth Pact. The higher than planned deficit-to-GDP ratio was due to overly optimistic revenue budget estimates. In 2013 the deficit as a percentage of GDP is forecast to decline by 0.6 percentage points to 2.7% as revenue is expected to increase thus offsetting the projected increase in expenditure.(9)

In 2010 there were 179 712 in the labour force (Table 3.2) with unemployment in 2012 at 6.5%.(2) Skills gaps continue to pose an obstacle to the efficient utilization of human capital. While there was an increase in employment in all segments of the labour market, including among older workers and women, the female employment rate remains the lowest in the EU (46.9% in 2012).(10) Although measures have been introduced to encourage female participation in the labour market, the government is highly committed to introducing further incentives in this respect.

Table 3.2 - Macroeconomic indicators, selected years1995 2000 2005 2010 2012

GDP (ESA 95) (euro millions) 3 054.0 4 121.0 4 938.0 6 377.0 6 830.0GDP, PPP (current international US$ millions) 5 692.0 7 262.0 8 488.0 11 096.0 12 138.0

GDP per capita (current US$) 9 717.5 10 377.0 14 809.9 19 624.9 20 847.6GDP per capita, PPP (current international US$) 15 364.6 19 041.6 21 018.6 26 672.2 29 013.5

GDP growth (annual %) 6.3 6.8 3.7 2.7 1.0Total general government expenditure (% GDP) N/A N/A 43.6 41.6 43.4

General government deficit/surplus (% of GDP) N/A N/A -2.9 -3.6 -3.3Tax burden (% of GDP) 30.0 28.9 34.0 33.0 33.7a

General government gross debt (% of GDP) 34.2 53.9 68.0 67.4 72.1Value added in industry (% of GDP) 50.0 50.8 37.8 32.7 N/A

Value added in agriculture (% of GDP) 2.9 2.4 2.6 1.9 N/AValue added in services, etc. (% of GDP) 47.1 46.9 59.5 65.4 N/A

Labour force (total) 143 108 151 726 164 411 179 712 N/AUnemployment, total (% of labour force) N/A 6.3 7.3 6.9 6.5

At risk of poverty or social exclusion (% of total population)b

N/A N/A 20.2 20.3 22.2

Gini coefficient of equivalized disposable income 26.9 (b) 28.4 27.2Real interest rate 1.8 3.0 2.9 1.6 2.3

Notes: ESA: European System of Accounts; PPP: purchasing power parity. a 2011 figure latest available; b Individuals in one of the following three conditions: at risk of poverty, severely materially deprived, or living in households with very low work intensity.Eurostat defines people at risk of poverty as: “those living in a household with an equivalized disposable income below the risk-of-poverty threshold, which is set at 60% of the national median equivalized disposable income (after social transfers). The equivalized income is calculated by dividing the total household income by its size determined after applying the following weights: 1.0 to the first adult, 0.5 to each other household members aged 14 or over and 0.3 to each household member aged less than 14 years old.”Eurostat defines the severely materially deprived as having: “living conditions constrained by a lack of resources and experience at least 4 out of the 9 following deprivation items: cannot afford 1) to pay rent/mortgage or utility bills on time, 2) to keep home adequately warm, 3) to face unexpected expenses, 4) to eat meat, fish or a protein equivalent every second day, 5) a one week holiday away from home, 6) a car, 7) a washing machine, 8) a colour TV, or 9) a telephone (including mobile phone).” Eurostat defines people living in households with very low work intensity as: “those aged 0–59 who live in households where on average the adults (aged 18–59) worked less than 20% of their total work potential during the past year. Students are excluded.”



The share of the population at risk of poverty and social exclusion is lower than the average in the euro area and compares favourably with that of the new Member States. The at-risk-of-poverty rate (the number of persons earning below 60% of the median national equivalized income) was 15.4% in 2011.(11) Nevertheless, the number of people at risk has grown considerably in recent years, with the most vulnerable groups being those below the age of 18 and the elderly people aged 65 and over. Just over one-fifth of children (21.1%) under the age of 18 and 18.1% of elderly people were found to be at risk of poverty in 2011.(11).

Political contextIn 1964 Malta obtained independence from Britain; the island became a republic in 1974. A liberal parliamentary democracy, Malta holds regular elections based on universal suffrage. The President is the head of state, while executive powers rest with the Prime Minister and the Cabinet. A unicameral Parliament made up of 65 representatives is elected every five years. This chamber serves as the national legislative body and also appoints the President.

The head of government is the Prime Minister, who is the leader of the party with an electoral majority. The main political parties are the socialist party, Partit Laburista, and the nationalist Partit Nazzjonalista, along with the much smaller Green party, Alternattiva Demokratika. In 1993 a system of local government consisting of local town councils was set up. Currently in Malta there are 68 local councils with elections held every three years. Over the past decade an increasing number of functions have been delegated to local government, or councils, in keeping with the government’s policy of decentralization. Their functions are related to local activities, including traffic management and waste collection. To date the local councils have not been delegated responsibilities for health care although some local councils house the primary health-care centres or small local clinics. Local councils will be more involved in the provision of community health care in the future.

In March 2013, the socialist party (Partit Laburista) was elected. The nationalist party (Partit Nazzjonalista) had previously been in government since 1987, save for a 22-month stint when the Partit Laburista was in power, between 1996 and 1998. Maltese political parties have aligned themselves with European parties – the Party of European Socialists (PES) in the case of the Partit Laburista and the European People’s Party (EPP) for the nationalist party; Alternattiva Demokratika has joined the European Greens.

Accession to the EU in May 2004 has largely dominated the political agenda in recent years. Malta is also a member of international organizations including the United Nations, the World Trade Organization, and NATO’s Partnership for Peace.

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Health statusLife expectancy at birth in 2011 was 81.0, 78.8 years for men and 83.1 years for women (Table 3.3).(4) The probability of dying in the younger age groups (15–60) has been decreasing steadily with a wide gap between males and females,(2) partly attributable to ischaemic heart disease and external causes of death such as traffic accidents and suicides. The total crude death rate in 2011 stood at 7.86, 8.04 for men and 7.68 for women.(4)

Table 3.3 - Mortality and health indicators, selected years1980 1990 1995 2000 2005 2010 2011

Life expectancy at birth, in years (total) 70.4 76.2 77.3 78.2 79.4 81.5 81.0Life expectancy at birth, in years (male) 67.9 73.8 75.0 76.0 77.2 79.3 78.8

Life expectancy at birth, in years (female) 72.9 78.4 79.6 80.3 81.4 83.6 83.1Crude death rate per 1 000 population (total) 10.4 7.7 7.3 7.7 7.8 7.2 7.9Crude death rate per 1 000 population (male) 11.1 8.0 7.5 7.9 7.9 7.2 8.0

Crude death rate per 1 000 population (female) 9.7 7.4 7.2 7.5 7.6 7.3 7.7Source: WHO (2013).

Diseases of the circulatory system are the leading causes of death, accounting for 45% of all deaths in 2011 (Table 3.4).(12) Despite a generally downward trend, ischaemic heart disease mortality rates are higher than the EU15 average. Diabetes mellitus accounts for 3.4% of all deaths, also higher than the EU15 average. Neoplasms are the second major cause of deaths, accounting for 27% of all deaths, while the rest of deaths are largely attributed to other causes (18%), diseases of the respiratory system (7%), and external causes of morbidity and mortality (3%).(12)

Neoplasms are the next most common cause of death and accounted for 27% of all deaths in 2011.(12) While the overall number of deaths has been increasing over time, standardized mortality rates reveal a downward trend that compares well with the EU15 and is more favourable than for the EU12. The average age at death due to neoplasms is 70 years, approximately nine years younger than for circulatory diseases.

Lung cancer followed by colorectal cancer, prostate, stomach and pancreatic cancer are the leading causes of death from neoplasms in males.(12). Breast cancer followed by colorectal cancer, ovarian, pancreatic and lung cancer were among the leading causes of death in females.(12) For most cancers there have been improvements in survival rates; however, survival rates are generally lower than in countries in the EUROCARE study.(13)



Table 3.4 - Standardized mortality rates per 100 000, main causes of death, selected years1980 1990 1995 2000 2005 2010

Communicable diseasesAll infectious and parasitic diseases (A00–B99) 9.0 8.0 6.5 5.6 3.4 0.9

Tuberculosis (A15–A19) (absolute number) 0.0 0.6 0.8 0.7 0.1 0.2Sexually transmitted infections (A50–A64) N/A N/A N/A 0.0 0.0 0.0

HIV/AIDS (B20–B24) 0.0 0.5 0.2 0.6 0.3 0.3Non-communicable diseasesCirculatory diseases (I00–I99) N/A 426.7 318.6 326.1 272.0 189.3

Malignant neoplasms (C00–C97) 202.2 166.7 198.2 171.0 145.4 151.7Colon cancer (C18) N/A N/A 19.2 17.7 14.4 13.4

Cancer of larynx, trachea, bronchus and lung (C32–C34) 38.8 32.4 35.7 29.9 26.7 29.8Breast cancer (C50) 54.6 37.7 47.8 45.6 28.1 25.8

Cervical cancer (C53) 0.7 2.3 3.7 2.3 1.0 0.7Diabetes (E10–E14) 89.5 31.4 22.3 18.9 22.1 17.2

Mental and behavioural disorders (F00–F99) 1.7 5.4 3.6 4.3 12.9 19.3Ischaemic heart diseases (I20–I25) 413.1 230.8 177.2 171.8 149.7 106.4

Cerebrovascular diseases (I60–I69) 151.5 99.9 79.7 73.7 63.2 42.5Chronic respiratory diseases (J00–J99) 68.7 66.7 63.0 68.4 60.6 47.1

Digestive diseases (K00–K93) 46.0 33.0 27.2 22.5 24.3 16.0External causes

Transport accidents (V01–V99) 8.4 2.5 6.4 4.1 4.5 3.6Suicide (X60–X84) 0.0 2.5 4.6 5.8 4.2 7.4

Ill-defined and unknown causes of mortality (R96–R99) N/A N/A 0.3 0.8 0.5 3.6Source: WHO (2013), Eurostat (2013). Note: a Standardization is based on European Standard Population (ESP).

The increase over the last decade in the standardized death rate for mental and behavioural disorders is mainly due to deaths attributed to dementia, which have increased to some extent because of changes in coding practices. The number of individuals with dementia was estimated to be around 4388 in 2010, equivalent to approximately 1% of the general population, and expected to increase to 5585 persons in 2020.(14) Recently, Malta launched a strategy to address the needs of persons with dementia, their families and carers as part of a holistic approach to dementia care.

Low mortality rates from infectious diseases can be attributed to widespread availability of antibiotics. The free syringe distribution programme for intravenous drug abusers, which started in Malta in the late 1980s, has resulted in low rates of HIV infection. A free childhood immunization programme for all children has also resulted in lower morbidity and mortality from vaccine-preventable infectious diseases.

Despite health gains, many risk factors associated with non-communicable diseases in Malta are on the rise. According to body mass index (BMI) data, the percentage of

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the male population that is obese has increased from 22.1% in 1984 to 29.6% in 2010 (Table 3.5). Data comparing Malta to other EU Member States in 2008 found that the proportion of males who are obese in Malta is the highest in the EU, while the proportion of females who are obese is third highest.(8). The proportion of children who are obese or overweight is also one of the highest when compared to children in 41 other countries.(15) According to the pilot European Health Examination Survey (EHES), 10.1% of the population between 20 and 79 years had diabetes in 2010.(16) Data comparing Malta with other EU Member States ranks Malta as having the fourth highest self-reported diabetes mellitus prevalence during 2008.(8)

Even though males still smoke more than females, the gap is shrinking. Deaths commonly associated with smoking, such as lung cancer and chronic obstructive pulmonary disease, are still more common among males. According to the latest European School Survey Project on Alcohol and other Drugs (ESPAD) carried out in 2011, 22% of Maltese students aged between 15 and 16 years participating in the study had smoked during the 30 days before the survey.(17) The study also found that 68% of those surveyed had consumed alcohol during the previous 30 days compared to the ESPAD average.(57%) Unhealthy eating has also been found to be increasingly prevalent.(18)

The infant mortality rate was 6.3 per 1000 live births in 2011, higher than the EU27 average of 5.76 and much higher than the EU17 average of 3.55 per 1000 live births (Table 3.6).(4) Caution needs to be exercised when interpreting such figures in view of the fact that termination of pregnancy is illegal in Malta. However, this fact alone may not fully explain such high mortality rates. There remains much scope for the conduct of an in-depth analysis to explore the reasons for such relatively high rates. The crude birth rate in 2011 was 10.3 per 1000 mid-year population (4283 live births) (19); there were 4239 live births in 2012.(20) The caesarean section rate is rather high, 335 per 1000 live births, when compared to the EU27 figure of 268.(4) Indeed, there has been an overall increasing trend in caesarean section rates over the past 14 years.(20) In 2012, 56.3% (2352) of deliveries were reported as having a spontaneous onset of labour, 28.1% (1174) were induced by drugs or artificial rupture of membranes and 15.5% (649) were carried out as elective caesarean sections. According to the National Obstetrics Information System (NOIS) the highest number of deliveries by maternal age group during 2012 was in the 30–34 year group and the average maternal age was 30 years. The percentage of births to teenage mothers has increased since the 1990s. In 2012, 5% of deliveries were for teenage mothers within the 15–19 age group.



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Table 3.6 - Maternal, child and adolescent health indicators, selected years1980 1990 1995 2000 2005 2010

% of all live births to mothers under 20 years of age 3.11 (1984)

2.7 3.1 5.6 5.9 6.4

Termination of pregnancy (abortion) rate 0.0 0.0 0.0 0.0 0.0 0.0Perinatal mortality rate (per 1 000 births) 17.9

(1985)10.9 9.9 7.3 5.4 7.9

Neonatal mortality rate (neonatal deaths per 1 000 live births)

12.0 6.7 7.4 5.3 4.4 4.5

Postneonatal mortality rate (postneonatal deaths per 1 000 live births)

3.6 2.8 1.5 0.7 1.6 1.0

Infant mortality rate (infant deaths per 1 000 live births) 15.5 9.5 8.9 6.0 6.0 5.5Probability of dying before age 5 years per 1 000

live births 18.1 11.0 10.2 6.8 6.7 6.5

Maternal mortality rate (maternal death per 100 000 live births)

53.6 0.0 21.7 0.0 0.0 24.9

Syphilis incidence rate per 100 000 population 0.0 5.0 5.8Gonococcal infection incidence rate per 100 000 population 0.8 5.7 11.3

Source: WHO (2013).

The National Immunization Service is responsible for the administration of all vaccines given to the public; the scheduled vaccines for infants and children up to 16 years are free of charge. While vaccination coverage for children is quite good (Table 3.7), a degree of under-reporting exists because some children are vaccinated in the private sector.

Table 3.7 - Vaccine uptake in Malta (%), 2008–2011Vaccine 2008 2009 2010 2011

BCG 86.4 82.0 91.0 83.7DTP1 88.0 91.0 97.0 100.0DTP3 71.5 73.0 76.0 95.7DTP4 64.0 63.0 78.0 76.7

Polio 1 88.0 91.0 97.0 100.0Polio 3 71.5 73.0 76.0 95.7

Hep B 1 60.8 88.0 76.0 94.2Hep B 3 86.0 86.0 75.0 81.5

Hib 3 71.5 73.0 76.0 95.7MCV 1 78.0 82.0 73.0 83.6MCV 2 83.0 85.0 97.2 85.1

Source: WHO (2013).



Chronic conditions associated with obesity, unhealthy lifestyles and ageing (such as dementia) are major challenges facing the population as a whole. A number of health policy documents, which have a strong focus on health promotion, primary prevention and intersectoral collaboration have been launched in recent years. As mentioned earlier these include the Non-communicable Disease Strategy 2010, the National Cancer Plan 2011, the Sexual Health Strategy 2011, the Healthy Weight for Life Strategy 2012 and the Tuberculosis Prevention Strategy 2012. An important aspect of the National Cancer Plan is the gradual and successive implementation of screening programmes, initiated in 2009 with breast screening, colorectal screening in 2012, and with cervical screening planned for 2014. Vaccination of young girls against cervical cancer started in 2012. There is some evidence that targeted policies have been successful: for example, there has been improvement in the number of people with high serum cholesterol (Table3.5), which may be due to specific legislation and policies introduced around 20 years ago regarding entitlement to free cholesterol medication.

PRINCIPAL HEALTH REFORMS

The main events of the past decade that have been most influential in shaping health reform are Malta’s accession to the EU in 2004 and the construction of the new Mater Dei Hospital in 2007. The former was instrumental in driving policy on new legislation in the field of health, particularly public health and health protection, while the latter was significant in shaping the flow of capital resources. Major health reforms that have taken place in recent years include use of HTA to define the public benefits package, introduction of the POYC scheme to provide more equitable access to medicines, and development of a remuneration system for medical consultants (specialists) that is partially performance based. There have also been efforts to develop more community-based services for long-term and mental health care. A new Mental Health Act, which will promote the rights of mental health patients and support community treatment schemes, was approved and came into effect in 2013. A landmark Health Act has also been approved by the Maltese Parliament in 2013, repealing the old Department of Health Constitution Ordinance and creating a modern framework separating policy from regulation and operations. This Act also enshrined patient rights in a legal instrument for the first time.

The focus on prevention and community services has led to progress in areas such as the development of cancer screening programmes. Since 2009, a number of national plans and strategies have been launched to address major public health issues, mainly cancer, obesity, sexual health and non-communicable diseases. An overarching National Health Systems Strategy (NHSS) is also being drafted to provide the overall direction. Notwithstanding, much remains to be done in this area, and this will be defined in the new NHSS.

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Analysis of recent reformsA reform process started within the Ministry for Health in 2006. A number of reforms and national strategies have been launched since then (Box 3.1). The following section describes each of these reforms in detail.

2007 – Restructuring to separate regulatory and service provider functions

2007 – Collective agreements with health-care unions

2007 – Commissioning of a new acute tertiary referral centre

2007 – Implementation of new IT systems

2008 – Pharmacy of Your Choice scheme

2008 – Pharmaceutical policy reform

2008 – Commissioning institutional care for elderly people from private providers

2008 – Setting up of a foundation programme and postgraduate medical training centre

2009 – Launch of breast cancer screening programme

2009 – Primary care reform proposal

2010 – Non-communicable Disease Strategy

2011 – National Cancer Plan

2011 – Sexual Health Strategy

2011 – Outsourcing of clinical services

2011 – Setting up of commissioners for health, for mental health and for elderly people

2012 – Embryo Protection Act

2013 – Move of social care from Ministry for Health to the Ministry for Family and Social Solidarity

2013 – Mental Health Act

2013 – Health Act

Box 3.1 - Major reforms and strategies since 2007

2007 – Restructuring to separate regulatory and service provider functionsWith Malta’s accession to the EU, important legislation to regulate aspects of health-care provision was implemented, notably in the areas of food safety, medicines, environmental health, public health and blood, tissues and cells. It was deemed pertinent to bring all these functions together under a single department, the Superintendent of Public Health, which would have as its remit public health regulation. Through this reform, a split between the responsibilities for setting standards and licensing of health-care providers



and that for the provision of a public health-care service was implemented. Although this was an administrative reform, it also signified an important step because the regulatory part of the Ministry for Health could apply the same standards to both government and private health-care providers in terms of standards of service provision.

2007/2008 – Collective agreements with health-care unionsPrior to the general election of March 2008, a number of important collective agreements were signed with the trade unions representing health-care professionals. These agreements paved the way for recognition of clinical specialist roles among professionals other than doctors. The agreement for medical doctors for the first time devised a different remuneration package for doctors who opted out of part-time private practice. The next round of collective agreements, in 2012, further refined the session-based system and extended it to the second highest level of doctors. Unfortunately, too few doctors have chosen this option to date, thereby diluting the impact of this policy initiative. However the introduction of part remuneration for sessional activity is an important concept in moving towards structured performance reviews and payment for activity. Agreements with nurses were intended to address the chronic nursing shortage. Engagement of nurses has increased notably, but not enough to plug the deficit fuelled by the increase in demand for health care.

2007 – Commissioning of new acute tertiary referral centreIn November 2007, a new 850-bed tertiary referral centre was commissioned, with all acute health-care services migrating from the old hospital to the new Mater Dei Hospital. The new facility’s infrastructure and equipment allowed for the development of a number of new services for which patients were previously referred abroad or managed conservatively. Activity levels in ambulatory care, patient admissions and surgical procedures have increased year on year since 2007. However the hospital is still not providing a full day of outpatient activity to reduce waiting lists for outpatients, as originally planned. Changes in health-care professional working practices have been difficult to implement. The acute hospital is also hindered by the health system not keeping up with the demand for alternative provision for frail elderly people unable to cope independently in the community, who often remain in the acute hospital for prolonged periods.

2007 – Implementation of new IT systemsThe new hospital paved the way for new IT systems, particularly in the area of radiology and laboratory information systems, which have been implemented nationwide and have revolutionized patient services. Further expansion of these systems is planned, fully taking into account the role IT can play in continuity of care between primary and secondary care.

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2008 – Pharmacy of Your Choice schemeUntil 2008, eligible patients could access free medicines through the public system only from regional health centres or local government dispensaries. In 2008 an agreement was signed with the private retail pharmacies and the professional organization representing pharmacists to implement the POYC scheme. Government-procured stock is supplied through all the pharmacies through a central logistics and distribution centre. Pharmacies are remunerated on a yearly capitation basis. Consequently, eligible patients can collect their medicines from any pharmacy of their choice, greatly facilitating access and swelling the number of beneficiaries. National coverage was achieved in 2013. It is hoped that pharmacists can be further engaged in reviewing the utilization of medicines.

2008 – Pharmaceutical policy reformThe necessity to implement the EU Transparency Directive (89/105EC) triggered the setting up of a directorate specifically for pharmaceutical policy in 2008. Legislation was amended in 2009 to introduce the concept of a maximum reference price at the point of approval of a medicine for inclusion on the government positive list. Evaluations of requests for entry to the positive list are carried out by means of HTA, relying heavily on other centres in Europe, mostly the National Institute for Clinical Excellence (NICE) in the United Kingdom for the technical evaluation and applying local epidemiology and costs to carry out the budgetary impact analysis. With newer medicines generally being more expensive than their older counterparts and in the current financial and economic climate, the acceptance rate for introduction on the government formulary seems set to decline. Innovative mechanisms to target new medicines for the most deserving patients are being piloted through, for example, clinical peer review committees for approving very expensive new medicines.

2008 – Commissioning institutional care for elderly people from private providersThe Government has been investing in the construction and direct management of a number of residences and nursing homes for elderly people. In seeking the optimum model to develop and run these institutions, the government has established various contracts with the private sector. Most recently, the government began purchasing beds in private facilities and paying a flat rate per diem according to dependency level. While this has been a popular policy measure, it has indirectly decreased demand for private long-term care. Each person in institutional long-term care has to contribute 60% or 80% of their income, depending on the institution. This deduction helps to pay part of the costs payable by the government. This commissioning role is still developing the skills and set-up required to monitor level of care, because of differences from the traditional public



set-up. The increase in nursing home capacity over the past years has not been sufficient to keep up with the growing demand.

2008 – Setting up of a foundation programme and postgraduate medical training centreEU accession accelerated migration of newly qualified doctors to around 80%. In response, the Ministry for Health set up a United Kingdom Foundation School in Malta. This project served to reverse the outward migration trend for new doctors (attracting foreign graduates too) as well as setting a benchmark for postgraduate medical training programmes. A new postgraduate medical training centre will enable medical doctors to enrol in several recognized and externally reviewed specialist training programmes following successful completion of the foundation programme.

2009 – Cancer screening servicesThe publication of the European Union Council recommendation on cancer screening programmes, led the Ministry for Health to set up a national breast cancer screening programme, despite a commissioned report that had not recommended this. Local scepticism centred round the resources that were required to be channelled into the programme. After a slow start in 2009, the programme has established itself and developed important quality assurance service benchmarks. Colorectal cancer screening was initiated in 2013, and the human papilloma virus (HPV) vaccine against cervical cancer was introduced into the national free immunization schedule.

2009 – Primary care reform proposalIn 2007 an extensive consultation process on strengthening primary health and community services established the need for some type of registration system with a GP. A working group developed a consultative document centred around setting up a patient registration system, based on the present context, in which 70% of primary care activity occurs in the private sector, in 2009. This was fiercely criticized by political and medical stakeholders. Different solutions for patient registration were proposed by different stakeholders. Civil society provided little support and government decided to initiate reform in primary care starting with measures with a broad consensus, such as IT systems access for private GPs, modernization of regional health centres, and further GP empowerment for lab investigations and prescriptions. Although a patient registration system, like previous attempts at primary health-care reform, is regarded as being effectively stalled, there is no doubt that sustainability of the health system depends on a cultural shift from secondary to primary care. The main obstacle is the popular belief that quality of care in a hospital setting is superior. Yet unless an integrated primary care

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pathway with an increasing gatekeeping role is developed, the hospitals will not be able to cope and endless outpatient hospital appointments and a revolving door syndrome will result. Renewed efforts are being made to strengthen and reform primary care services.

2010 – Non-communicable Disease StrategyIn 2010 the Non-communicable Disease Strategy for Malta was launched in collaboration with the WHO, defining priorities for common ailments, particularly cardiovascular disease and diabetes, and guiding health promotion and disease prevention programmes for the coming years.

2011 – National Cancer Plan Malta adopted its first ever National Cancer Plan early in 2011, bringing together prevention, screening, care and support. The National Cancer Institute in France provided expert input. The plan sets out timed targets and deliverables, and its implementation to date has been satisfactory particularly in the areas of health promotion, expansion of access to medicines and the construction of a new cancer facility, funded through EU Structural Funds.

2011 – Sexual health policy and strategyA long-awaited sexual health policy was published in 2010, facilitating discussion with stakeholders presenting very different perspectives. The concept of individual empowerment in one’s relationships, and the accompanying rights and responsibilities were a main tenet. Maximal ownership by stakeholders and other policy sectors was thus achieved and a strategy document was published in 2011, which upholds the applicable public health principles. Implementation is under way.

2011 – Outsourcing of clinical services To further decentralize service provision and facilitate patient access, the Ministry for Health began outsourcing surgical services to the private sector in 2011, in a bid to reduce waiting times for elective interventions by boosting activity. Following some initial problems with acceptance of such an innovative approach, cataract surgery services were commissioned from the private sector. This project was also rolled out for MRI services, arthroscopy services and weekend cover for triage level 3 emergencies. These were considered as pilot projects, heralding an organized commissioning and outsourcing process through which private and public providers can equally provide public health-care services, challenging the traditional link between public health-care services and government-operated health-care facilities. It also sets the agenda for the development of activity and target-based part-funding rather than full funding through a global cash budget independent of throughput.



2011 – Setting up of commissioners for health, for mental health and for elderly peopleThe government has created three new posts designed to empower patients. The Commissioner for Health was established as part of the legislation regulating the Office of the Ombudsman, to investigate complaints received from citizens dissatisfied with the health services. The Commissioner for Health may also investigate aspects of the health service through “own initiative” measures. The Office of the Commissioner for Mental Health and that of Commissioner for Older People are separate. While the Commissioner for Mental Health already has a defined role laid out in the draft Mental Health Act legislation, the necessary legislation to protect older people still has to be drafted and this is the role currently being undertaken by the appointed Commissioner for Older People. These offices have been a first step towards addressing European criticism levelled at Malta regarding its patients’ rights framework.

2012 – Embryo Protection ActAn Embryo Protection Act has set up an authority to oversee artificial reproductive technologies and eligibility for such treatment. This has paved the way for these procedures to be offered within the public health service in a regulated manner. In order to allow multiple IVF cycles to occur without the woman being exposed to the harrowing oocyte harvesting process, storage technologies need to be in place. The main technology that is expected to be used is oocyte vitrification to circumvent the ethical implications of embryo freezing.

2013 Mental Health ActThe Mental Health Act, enacted in 2013, revolutionized the status of the mental patient in Maltese law. It replaces older legislation, where the mentally ill individual barely had any rights and in which care was effectively limited to institutionalized care. The new Act grants the appropriate dignity to the mentally ill patient and paves the way to better care within the community. It also grants legal status to the position of the Commissioner for Mental Health, particularly for protecting the rights of the patients and carers.

2013 Health ActThe Health Act, enacted late in 2013, is another landmark legislative instrument which replaces the somewhat archaic Department of Health Constitution Ordinance of 1937. The Health Act establishes the basic functions in the public health set-up, clearly delineating three separate roles: regulation, strategy and coordination of health-care services, together with a number of advisory entities that bring the three functions together. It also makes a declaration on patient rights and responsibilities. While the Health Act is not exhaustive

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in the delineation of the granular operation of the health ministry, nevertheless it provides an adequate framework for further implementing legislation.

FUTURE DEVELOPMENTS

While much progress has been made in recent years, some reforms have been less successful. A major challenge for the health system is ensuring financial sustainability. Financial projections depict unsustainable public finances in the medium to long term, in view of projected increases in age-related expenditure. Older people often require intensive care and support within the community or within institutions. Insufficient placements in long-term care and inadequate support for the dependency levels being encountered at community level results in a situation where beds are inappropriately taken up within the acute hospital. Generally speaking, when it comes to ageing, current policies are geared towards hospitalization and institutionalization. These are policies that send the wrong signals for they assume hospitalization and institutionalization at the first instance, that is, as soon as the first signs of sickness or disability appear.

The primary care reform has not achieved as much attention as intended. The provision of primary care services by the state is limited as the private sector accounts for two-thirds of the workload in this respect and functions independently from the public sector. The system of GPs acting as gatekeepers to further levels of care is very often bypassed. This points to a weakness in the system as a whole and possibly contributes to inefficient use of health-care resources and longer waiting times for hospital care. Further, the relatively limited number of nurses and GPs per capita also results in bottlenecks in the provision of primary care services and adds to longer waiting times for hospital care. Indeed, long waiting times for outpatient appointments and elective interventions pose a major problem. This issue is complex and what is required is that inappropriate referrals should be tackled effectively, a strong primary care led service should be developed, there should be greater efficiency, and the number of hours Mater Dei Hospital is open should be extended. Another supply constraint seems to lie within the availability of free drugs, as defined under Schedule V of the Social Security Act. A number of instances still occur each year when certain medications tend to be out of stock for a number of days. This is likely to be due to a combination of the ever-increasing number of beneficiaries and issues within the procurement and distribution process. Another issue that demands attention is the infant mortality and amenable mortality rates. Infant mortality in Malta in year 2011 stood at 5.5 per 1000 live births compared to 4.1 per 1000 in the EU; amenable or avoidable mortality rates, that is those that could be reduced if there were timely and effective care, are high in a series of important causes of death. Strategies recently put in place all aim to reduce premature deaths, address risk factors, decrease morbidity, promote healthy



lifestyles and improve quality of life. The above issues featured as significant elements in the Labour Party’s electoral manifesto in 2013 and today feature prominently in the programme of priority initiatives of the Labour government.

ASSESSMENT OF THE HEALTH SYSTEM

The Maltese health system provides a comprehensive basket of health services available universally for all its citizens. According to EU-SILC data,(8) self-reported unmet need due to financial constraints in 2010 was low in comparison to other European countries, reflecting Malta’s major focus on providing equal access to health services for all, particularly for disadvantaged groups. Indeed, socioeconomic inequalities are more evident among health determinants, such as obesity and health literacy, rather than health-care access.

Maltese citizens enjoy one of the highest life expectancies in Europe. The objectives set out in Health vision 2000 (the original strategic document written by the Ministry for Health in 1995) have been at the heart of all health policies and reforms that have occurred since then. Strategies that have recently put in place, all aim to reduce premature deaths, address risk factors, decrease morbidity, promote healthy lifestyles and improve quality of life. A major challenge for the health system is ensuring sustainability, as Malta faces increasing demands from its citizens, an ageing population, and the rising costs of medicines and technology. To address the sustainability of public finances, there is a focus on maximizing efficiency together with investment in primary and community-based health care and social care. Systematic monitoring of health system performance has also become imperative. The adoption of a comprehensive healthy active ageing strategy that seeks to help older people to stay within their own home setting is a crucial component that taps directly into the notion of sustainability.

Stated objectives of the health systemThe objectives of the Maltese health system are stated in the new Health Act. Accordingly the Act intends to “establish and ensure a health system based on the principles of equity, accessibility, quality and sustainability by regulating the entitlement to, and the quality of, health-care services in Malta, consolidating and reforming the Government structures and entities responsible for health and by providing for the rights of patients”.(21)

A new National Health System Strategy (NHSS) is currently under development; four primary objectives of the health system have emerged: 1. Respond to increasing demand and challenges posed by the demographic changes

and epidemiological trends focusing on course of life, children, elderly people and vulnerable groups;

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2. Increase equitable access, availability and timeliness of health and social services, medicines and health technologies;

3. Improve quality of care by ensuring consistency of care and having qualified health personnel supported by robust information systems;

4. Ensure the sustainability of the Maltese health system.Likewise, a number of policy documents with a strong focus on health promotion and primary prevention have been launched in the last few years, reflecting high-priority policy objectives. There is a political commitment to inter-sectoral approaches and health in all policies.

Financial protection and equity in financingThe government is committed to preserving the solidarity-based model of universal access to care. There are no user charges for public services. Out-of-pocket payments, however, are still the dominant financing mechanism for the private sector, accounting for around one-third of total health expenditure. Although it is estimated that around one-fifth of the population has private health insurance, most are basic plans that provide very limited hospital care. Despite the high frequency of spending by households, most of this spending is for relatively inexpensive ambulatory care services, dental care and medication, mostly for acute, self-limiting illness. Health-care expenditure is regressive since lower-income households spend a larger proportion of their income on health. According to the Household Budgetary Survey for 2008, 6.4% of total expenditure by households is on health-related expenditure.(22) Lower-income households spend a larger proportion of their income on health than their higher-income counterparts at 9% and 5%, respectively. The system as a whole could be seen as progressive, however, because higher earners pay more in taxes, which are used to finance the public system.

User experience and equity of access to health careAt Mater Dei Hospital, suggestion boxes have historically been used to allow patients to convey their comments and suggestions on a specific form and patient satisfaction surveys are increasingly being employed. An example of such a survey is the Mater Dei Hospital Patients’ Experience Survey.(23) Notwithstanding the overall positive experience of service users (with 80% rating the care received to be excellent or very good), there are gaps in service provision that need to be addressed, such as better communication between health-care professionals and patients. In this Patients’ Experience Survey, 97% of patients were satisfied with the general ambience of the new public hospital while 95% stated that they had full trust in the medical staff. Recently, this feedback process has been modernized through the introduction of an interactive online customer care survey available at patients’ bedside on the personal entertainment system. Patients are



strongly encouraged to fill it in and volunteer helpers also offer their assistance should the patient not be IT literate, in order to get as representative a picture as possible. A variety of dimensions are being continually assessed through this medium and fed back to both individual wards and to management.

All efforts are made to ensure confidentiality as personal data is processed, managed and stored in accordance with the Data Protection Act 2001. This extends to both medical records in digital format and those in paper format. Access for purposes of research is regulated by the Chief Executive Officer, who may delegate his authority to the Director for Information Management and Technology. In specific situations, ethical approval may be sought before such access is granted.

Waiting times are a long-standing challenge in both health and long-term care, which may have an adverse impact on the health and quality of life of patients, apart from reducing their overall satisfaction with the health and long-term care systems. Transferring responsibility for certain services from the institutional, secondary and tertiary sectors to the primary and community sectors will be an important component of this solution as well as an increase in the provision of those services where longer waiting times exist. In both settings, waiting times and lists are being monitored. In the health-care setting, a large number of surgical procedures and outpatient clinics are being monitored. As at the end of June 2013, there were 1926 individuals who had been waiting for cataract surgery for more than six months. Admittedly this number was much higher prior to cataract surgery being commissioned from the private sector. While the median waiting time is now around 12 months, it was closer to 36 months prior to this subcontracting. A similar problem exists with a select number of orthopaedic procedures, with typical waiting times being between 24 and 36 months.(24) A two-pronged approach is being taken to address these waiting lists, cutting back on the existing list, and addressing capacity to meet demand based on the observed throughput of new cases.

Inability to access health services for geographical reasons is not a major issue due to the small size of the country. Nevertheless, to ensure that residents of Gozo have better access to care closer to home, the government is investing EU Structural Funds to purchase new equipment for the operating theatres and a radiology department in Gozo General Hospital. Evidence from EU-SILC suggests very low levels of unmet need due to financial barriers. As shown in Fig.3.2, only 0.8% of the Maltese population reported not having had a medical examination in the previous year for financial reasons, as compared to an EU average of 2.3%.(8)

Efforts are also being made to focus on improving access to services for migrants. All health-care needs of migrants are catered to; appreciably, this has presented new challenges to the health system. As an example of an initiative effectively meeting the needs of migrants, a bill to ban female genital mutilation is currently being discussed in

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Parliament. There are dedicated clinics for migrants and a Migrant Health Unit, as well as cultural mediators to facilitate access and overcome language and cultural barriers.

86

Efforts are also being made to focus on improving access to services for migrants. All

health-care needs of migrants are catered to; appreciably, this has presented new challenges to the

health system. As an example of an initiative effectively meeting the needs of migrants, a bill to ban

female genital mutilation is currently being discussed in Parliament. There are dedicated clinics for

migrants and a Migrant Health Unit, as well as cultural mediators to facilitate access and overcome

language and cultural barriers.

Source: Eurostat 2013 (8)

Figure 3.2 - Percentage of unmet need for medical examination due to financial reasons -

Health outcomes, health service outcomes and quality of care

Maltese citizens enjoy one of the highest life expectancies in Europe. Nonetheless, there

remains scope for improvement, particularly through compressing morbidity in older age groups and

reducing amenable mortality rates. There remains scope for improvements in further reducing

prevalence as well as deaths due to ischaemic heart disease. This requires an aggressive approach

targeting risk factors, such as obesity, careful control of hypertension and diabetes, and more

effective and timely interventions in the hospital setting. For cancer, Malta compares favourably

with other EU countries; efforts are under way to strengthen cancer services by expanding the newly

introduced screening for breast and colorectal cancers.

While initiatives exist that capture some data on health service outcomes, there is no

comprehensive system to capture health service outcomes and quality of care. Therefore, a project is

Figure 3.2 - Percentage of unmet need for medical examination due to financial reasons Source: Eurostat 2013 (8)

Health outcomes, health service outcomes and quality of careMaltese citizens enjoy one of the highest life expectancies in Europe. Nonetheless, there remains scope for improvement, particularly through compressing morbidity in older age groups and reducing amenable mortality rates. There remains scope for improvements in further reducing prevalence as well as deaths due to ischaemic heart disease. This requires an aggressive approach targeting risk factors, such as obesity, careful control of hypertension and diabetes, and more effective and timely interventions in the hospital setting. For cancer, Malta compares favourably with other EU countries; efforts are under way to strengthen cancer services by expanding the newly introduced screening for breast and colorectal cancers.

While initiatives exist that capture some data on health service outcomes, there is no comprehensive system to capture health service outcomes and quality of care. Therefore, a project is under way in collaboration with the WHO to put in place a Health System Performance Assessment framework that will allow the regular and timely monitoring of a selected number of performance indicators. Data collected include a number of Organisation for Economic Co-operation and Development (OECD) Health-Care Quality



indicators, the Performance Assessment Tool for Quality Improvement in Hospitals (PATH) initiative measures and various others. Since 2009, Mater Dei Hospital has been collecting seven performance indicators for PATH. These were: caesarean section rate; patient-based stroke 30-day in-hospital mortality rate; patient-based acute myocardial infarction 30-day in-hospital mortality rate; use of blood components; exclusive breastfeeding; prophylactic antibiotic use; and operating theatre performance. One particular area of concern locally has been the caesarean section rate. In 2010, Malta had reportedly the fourth highest section rate in Europe, (25) and, like most other countries the rate has increased since 2004.

Malta participates in the European Health-Care Associated Infections Surveillance Network (HAI-NET) coordinated by the European Centre for Disease Prevention and Control (ECDC). In addition, Malta participates in the Antimicrobial Resistance Surveillance Network (EARSNet) which is a European wide network of national surveillance systems, providing European reference data on antimicrobial resistance for public health purposes. Methicillin-resistant Staphylococcus aureus is one main source of hospital infection in Malta. In 2006, the percentage of Staphylococcus aureus isolates resistant to methicillin was as high as 66.7%. Thanks to various campaigns and measures within hospital practices this has been driven down to 49% by 2011. (26)

With regard to maternal care, Malta participates in the EURO-PERISTAT network, which aims to contribute to better health for mothers and babies (25). In spite of the two indicators mentioned earlier, caesarean section rate and infant mortality rate, Malta performs fairly well in a number of other areas. The percentage of women starting antenatal care within the second trimester is, by far, the highest in Europe. Maternal mortality in Malta is among the lowest with only two deaths between 2002 and 2011. The percentage of babies born with low birth weight is also on a par with the European average. On the other hand, breastfeeding rates at 48 hours after birth are among the lowest in Europe.(4,25)

As described earlier, a number of vaccinations are made available to Maltese citizens as per the National Immunization Schedule. Vaccination coverage in children is around 96% for most vaccines, with the exception of the MMR vaccine whose uptake is still low, even compared to the EU average.(4) Influenza vaccination uptake among the elderly, while reported as the third highest in Europe, is still below public health recommendations.(27)

Malta is working towards a legal framework for patient safety through the preparation of subsidiary legislation to be published under the Health Act. To date, there is no system that collects data in a comprehensive manner.

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Equity of outcomesSocioeconomic inequalities, as evidenced by the Gini coefficient, are less pronounced in Malta (27%) then in the remainder of the EU (30%).(8) Health inequalities by level of income or by region in Malta are typically largely explained by differences in level of education achieved. Even when adjusted for age differences among the educational groups, certain inequalities persist, such as the presence of chronic illness, activity limitation or lower self-perceived health. All of these show evidence of marked differences by educational level. At a more specific level, certain diseases also show such inequality by level of education, such as lung cancer and chronic lower respiratory disease.(16) A number of lifestyle practices also show differences by level of education, typically smoking, obesity and alcohol consumption.(27)

In addition, the typical gender inequalities observed in Western nations are observed in Malta, such as activity limitation and self-perceived health. These are typically more pronounced in the elderly cohort, especially given the longer life expectancy in women. A number of adverse lifestyle characteristics are more pronounced among men, including as obesity, smoking and alcohol consumption, while lack of physical activity is more pronounced among women. Interestingly, obesity awareness was found to be markedly lower among women, on the other hand.(16)

Nevertheless, no formal framework exists to monitor equity in health care. Further work in this area is required, particularly on inequalities experienced by migrants. Sporadic reports have been produced by a number of entities on the barriers to health care for migrants in Malta, and a number of these concerns have been partially addressed or mitigated, as discussed earlier. Very little in the way of official health statistics are available for the migrant population to date. Following the lull in migrant arrivals experienced during the latter years of the Gaddafi regime in Libya, this became less of a priority. However, in view of the recent resurgence of illegal migration flows from North Africa, measuring and addressing the inequities migrants are experiencing as compared to the native population becomes imperative.

Health system efficiencyThe health system must compete with other public sectors like education and social security for allocation of scarce funds. Budgeting is traditionally based on historical expenditure. In recent years HTA has been increasingly used for deciding whether to introduce new medicines and technologies. However, there is no explicit threshold for inclusion in the package of services offered through the public health system. The Health Act has set up a formal structure, known as the Advisory Committee on Health Benefits, whose mandate will be to advise on allocation of resources. This Committee will continue to build on the experience attained through the Government Formularly List Advisory Committee,



which has been used to prioritize decisions regarding inclusion of new medicines. The formal setting up of HTA in accordance with the Directive on the application of patients’ rights in cross-border health care will facilitate the application of HTA in Malta which, as a small country, needs to rely heavily on empirical evidence obtained from other settings.

Within the public sector, there has historically been an emphasis on allocation of resources for hospitals to the detriment of the primary care and other community services. Even within secondary care there are allocative inefficiencies. In terms of current capacity, the current allocation of beds across acute, rehabilitative and long-term care does not adequately address demand for services. This is partly due to changes in demographics, as well as changes in capacity.

Improvement of technical efficiency is a key priority for the Maltese health system. The setting up of the Financial Monitoring and Control Unit with satellite units across all public health service providers was a step in the right direction. However efforts should be intensified to merge clinical performance and financial data in order to make appropriate decisions on achieving much-sought efficiency gains. Inefficiencies are apparent due to the recent rise in average length of stay in acute hospitals, a relatively low day surgery rate and considerable clinical variations in practice resulting in different thresholds for diagnostics, interventions and follow-up outpatient visits. The lack of price incentives in the system makes it harder as this means that technical efficiency gains need to be made solely through supply-driven reforms.

Better integration between hospital and community services, empowerment of GPs and community discharge planning and liaison services are critical factors for improving technical efficiency. Another source of inefficiency is the current mechanism in place to procure medicines and medical supplies. The systems are overly bureaucratic and do not guarantee timely supply at the right price. A thorough review and reform of the procurement processes is under way, with a view to avoiding problems over out-of-stock drugs, curbing waste and improving the value through lower pricing.

In terms of human resources, there has been an increasing trend to support health-care professionals with carers and paramedic aides, thereby expanding the range of skill mix available to the system. Pay for performance is generally not employed within the public health service, where human resources are salaried. However, senior medical specialists are subject to annual job planning built around flexible sessions which, if properly managed, could serve to create the correct incentives to improve system performance and output. Technical efficiency will begin to be monitored annually through a Health System Performance Assessment, the framework of which is presently under development.

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Transparency and accountabilityTransparency and accountability are considered to be key values for the health system but they are as yet insufficiently dispersed through the system. During health policy development and implementation there are consultations with all stakeholders and public participation in such processes is strongly encouraged. Patient participation has been traditionally low, with a strong asymmetrical influence by associations of health professionals in the health NGO field. The situation is changing, however, with some patient groups becoming more involved and more vocal. Since 2009, the public health service has made the register of health benefits publicly available for both services and medicines. Nonetheless, this is often challenging to navigate for the lay public. There is a thrust to continue to increase the information available in the public domain. A measure that has been considered in order to improve transparency is the publication of the maximum reference price. This measure has been heavily contested by the pharmaceutical stakeholder bodies and has not been implemented to date.

The Ministry for Health is determined to increase the accountability of the Maltese health system by creating capacity for performance monitoring and the creation of a framework wherein monitoring and evaluation must address performance in terms of both health system measures such as availability, access, quality and efficiency, and population health measures like health status, responsiveness, user satisfaction and financial risk protection. The Ministry for Health is committed to move towards the setting up of specialized business units within hospitals such that a culture of accountability for resource consumption is inculcated among clinical professionals whose activities ultimately determine expenditure in the health system.



REFERENCES

1. Malta in Figures 2012. National Statistics Office Malta; 2012.2. World Bank. World Development Indicators Database [online database]. [cited 2013 Oct]

Available at: http://publications.worklnk.org/WDI/indicators. 3. Demographic Review 2010. National Statistics Office Malta; 2011.4. World Health Organisation Regional Office for Europe. European Health for All Database

(HFA-DB) [online database]. Available at: http://www.euro.who.int/hfadb, 2013.5. Census of population and housing 2011- preliminary report. National Statistics Office

Malta; 2011.6. European Commission Directorate General for Economic and Financial Affairs. The

2012 ageing report - economic and budgetary projections for the 27 EU Member States (2010-2060). [cited 2013 Oct 15]; Available at: http://ec.europa.eu/economy_finance/publications/european_economy/2012/2012-ageing-report_en.htm.

7. Census 2005. National Statistics Office Malta; 2007.8. Your key to European statistics Eurostat [online database]; [cited 2013 Jun 30]. Available at:

http://epp/eurostat.ec.europa.eu/portal/page/portal/statistics/search_database. 9. Pre budget document 2014. Ministry for Finance Malta; 2013.10. Commission Staff working document: assessment of the 2013 national reform programme

and stability programme for Malta (SWD (368); [cited 2014 Jan 7]. Available at: http://ec.europa.eu/europe2020/pdf/nd/swd2013_malta_en.pdf.

11. Focus on children and the elderly. News release, SILC 2011: National Statistics Office Malta; 2013.

12. National Mortality Registry - annual mortality report 2011. Directorate for Health Information and Research; [cited 2013 June 30]. Available at: https://ehealth.gov.mt/download.aspx?id=9514.

13. Berrino F, De Angelis R, Sant M, Rosso S, Lasota MB, Coebergh JW, et al. Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995–99: results of the EUROCARE-4 study. Lancet Oncol 2007; 8(9):773-783.

14. Abela S, Mamo J, Aquilina C, Scerri C. Estimated prevalence of dementia in the Maltese islands. Malta Med J 2007; 19(2):23-26.

15. Currie C, Gabhainn S, Godeau E, Roberts C, Smith R, Currie D, et al. Inequalities in young people’s health: international report from the HBSC 2006/06 survey (Health Policy for Children and Adolescents, No. 5). WHO Regional Office for Europe; Copenhagen. 2008.

16. Directorate for Health Information and Research. European Health Examination Survey: pilot study 2010. [cited 2013 Jun 30] Available at: https://ehealth.gov.mt/HealthPortal/chief_medical_officer/healthinfor_research/surveys/european_health_examination_survey.aspx.

17. Hibell B, Guttormsson U, Ahlström S, Balakireva O, Bjarnason T, Kokkevi A, et al. The 2011 ESPAD report. Substance use among students in 2012; 36.

18. Food Consumption Survey 2010 Report. Malta Standards Authority; [cited 2013 Jun 30]. Available at: http://www.doi-archived.gov.mt/EN/press_releases/2011/01/pr0093.ppt.

19. Malta in Figures 2012. National Statistics Office Malta; 2012.20. National Obstetrics Information System (NOIS) annual report 2012. Directorate for Health

Information and Research; [cited 2013 Jun 30]. Available at: https://ehealth.gov.mt/download.aspx?id=9493.

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21. Chapter 528 (Laws of Malta), Health Act, Part I, Article 3.Government of Malta; [cited 2014 Jan 10]. Available at: http://www.justiceservices.gov.mt/DownloadDocument/.aspx?app=lom&itemd=12112&1=1.

22. Household Budgetary Survey. National Statistics Office Malta; 2008.23. Health Care Standards Directorate. Patients’ experience at Mater Dei Hospital - pilot study

June-July 2010. 24. Parliamentary Question No.2310, 29th session of the 12th Legislature 11 June House of

Representatives. 2013.25. EURO-PERISTAT. European perinatal health report. [cited 2013 Jun 30]. Available at:

http://www.europeristat.com/images/doc/EPHR/european-perinatal-report.pdf.26. European Centre for Disease Prevention and Control. TESSy The European Surveillance

System 2013 [online database]. [cited 2013 Jun 30]. Available at: http://www.ecdc.europa.eu/en/activities/surveillance/tessy/Pages/TESSy.aspx.

27. European Health Interview Survey 2008. Directorate for Health Information and Research.;[cited 2013 Jun 30]. Available at: https://ehealth.gov.mt/HealthPortal/chief_medical_officer/healthinfor_research/surveys/european_health_interview_survey_2008.aspx.

CHAPTER 4Europeanisation of Health Systems:

A qualitative study of domestic actors in a small state

Azzopardi-Muscat N., Sorensen K., Aluttis C., Pace R., Brand H. Europeanisation of Health Systems: A qualitative study of domestic actors in a small state:

BMC Public Health. 2016, 16:334 DOI:10.1186/s12889-016-2909-0 URL:http://www.biomedcentral.com/1471-2458/16/334

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ABSTRACT

Background: Health systems are not considered to be significantly influenced by European Union (EU) policies given the subsidiarity principle. Yet, recent developments including the patients’ rights and cross-border directive (2011/24 EU), as well as measures taken following the financial crisis, appear to be increasing the EU’s influence on health systems. The aim of this study is to explore how health system Europeanisation is perceived by domestic stakeholders within a small state.

Methods: A qualitative study was conducted in the Maltese health system using 33 semi-structured interviews. Inductive analysis was carried out with codes and themes being generated from the data.

Results: EU membership brought significant public health reforms, transformation in the regulation of medicines and development of specialised training for doctors. Health services financing and delivery were primarily unaffected. Stakeholders positively perceived improvements to the policy-making process, networking opportunities and capacity building as important benefits. However, the administrative burden and the EU’s tendency to adopt a ‘one size fits all’ approach posed considerable challenges. The lack of power and visibility for health policy at the EU level is a major disappointment. A strong desire exists for the EU to exercise a more effective role in ensuring access to affordable medicines and preventing non-communicable diseases. However, the EU’s interference with core health system values is strongly resisted.

Conclusions: Overall domestic stakeholders have a positive outlook regarding their health system Europeanisation experience. Whilst welcoming further policy developments at the EU level, they believe that improved consideration must be given to the specificities of small health systems.

KeywordsHealth policy, Health system reforms, European Union, Europeanisation, Qualitative study, Small states, Malta


Europeanisation of Health Systems: A qualitative study of domestic actors in a small state | 83

BACKGROUND

The European Union (EU) acquired a health mandate in 1992 through the Maastricht Treaty, which is enshrined in Article 168 of the Treaty on the Functioning of the European Union (TFEU).(1) This article must be read in conjunction with articles 3, 4 and 5 of the TFEU, which defines the competencies of the EU and the Member States as well as the so-called ‘mixed competences’. The essence of these Treaty provisions is that heath remains a Member State competence and Union action can only complement national policies but not supplant them. Therefore, in accordance with the principle of subsidiarity, the Union acts only insofar as the objectives of the proposed action cannot be sufficiently achieved by the Member States. Hence, the responsibility for organising and financing health systems remains a Member State responsibility in accordance with the principle of subsidiarity.(2-3) Of course, this position leads to some ambiguity, which is also reflected in the mixed outcomes of European health policy.(4-5) European level stakeholders perceive the results of the EU health policy as a mixture of achievements, failures and missed opportunities.(6) Whereas the EU has become a recognised player in the health sector, the extent to which it has actually made a difference to the health of European citizens is debated.(7-9) The EU has been described as exerting its influence on health systems through three main strands of activity: public health, market regulation and the European Semester.(10-11) This situation has led to primarily ‘uninvited’ Europeanisation of health systems often resisted by domestic stakeholders.(12) The effects of austerity policies with the concomitant reduction in health budgets,(13) particularly in Greece and Spain, have tended to generate a negative perception of EU action with regard to health systems.(14-16) An analysis of Country Specific Recommendations (CSRs) found that the European Semester1 system of fiscal and economic governance emphasises the financial sustainability of health systems over quality and accessibility.(17) Early analysis of the implementation of the patients’ rights and cross border care directive indicates the variable effects on Member State health systems.(18-23) These developments point to an increasingly important role for the EU in influencing health systems. In contrast, the Mission Letter issued by Juncker to the health commissioner in 2014 sends a clear message that the policy on health systems is best left to individual Member States.(24) Therefore, the future role of the EU regarding health systems appears unclear at this point, with either role expansion or retrenchment being possible outcomes.

The concept of Europeanisation has developed over time and has been largely defined as an outcome or a process.(25)2 This paper adopts Radaelli’s definition of Europeanisation as ‘a series of top-down and bottom-up processes affecting both formal and informal rules as well as procedures, policy paradigms, styles and shared beliefs and norms’.(26) This definition was selected because it includes policy instruments other than legislation and, therefore, is

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suitable for an assessment of health system Europeanisation considering that EU action in this policy area is often pursued through instruments other than legislation.(27) An examination of the domestic impact of the EU on the Maltese health system can be classified using the four types of outcomes that were described in the Europeanisation literature,(28) namely: inertia, or Europeanisation occurring involuntarily if at all; retrenchment, or the continual resistance of EU pressures; adaptation, or making certain changes that do not affect the fundamentals of the system; and engaging in transformations that change the foundations of the domestic system, leading to paradigm shifts. The ‘goodness of fit’ hypothesis,(29) although discredited as being too mechanistic and lacking empirical evidence in certain respects can still be usefully applied to an analysis of the Europeanisation of the Maltese health system.(25,30) One expects that a high degree of misfit leads to transformation if domestic actors see value in adopting the European policy and actively utilizing the EU requirements as leverage to bring about change. Retrenchment or inertia would result where a conflict in values exists or the price tag associated with change is perceived to be too high from a domestic perspective. Adaptation or accommodation is likely to occur in situations where the degree of misfit is not unbearably high. Additionally, the literature on Europeanisation emphasises the importance of networks of elite stakeholders as mediating factors in determining the overall effects of the EU on individual Member States. (31-33) An investigation of domestic stakeholders’ viewpoints regarding the impact of the EU on their health system can be important in furthering our understanding of the manner in which the Europeanisation of health systems occurs. In addition, obtaining an understanding of domestic stakeholder expectations regarding the role that should be played by the EU in health systems can inform the manner in which health system Europeanisation occurs in the future.

Malta, which joined the EU in 2004, was selected as the setting for this study. Malta exhibits a relatively high level of engagement with the EU, as exemplified by the country’s positive track record in implementing legislation.(34) Malta is the smallest EU Member State and has no internal regional structures. A review of the effects of EU membership after a decade carried out at the national level found that several sectors had been transformed, but also that the health sector does not receive any particular mention, which is consistent with the view that the health sector should be considered as a case of ‘least likely’ Europeanisation.(33,35) An examination of the impact of EU membership on the public service found that areas significantly affected by EU policy, such as customs and rural development, underwent significant policy change accompanied by structural and procedural reform. Areas less influenced by EU policy underwent little change. Following EU accession, two distinct types of public administration can be identified in Malta, namely that which is involved in EU policy and that which is unaffected by EU



policy. That EU membership was a strong driver of public service change was concluded.(34)

Studies on the Europeanisation of health care were identified for cross-border mobility, health care coverage, alcohol policy, communicable disease policy and cancer.(36-43) However, to date no empirical studies were found that investigated the attitudes of domestic stakeholders towards health system Europeanisation.

In this paper, we apply the theory from European studies to explore the effect of the EU on health systems as experienced by domestic actors in the small EU Member State of Malta. Specifically, we assess how EU membership affected the Maltese health system. We also explore the attitudes of domestic health system stakeholders to the EU and seek their views on the future role they envisage for the EU with respect to health systems. We seek to fill an identified gap in the literature by going beyond an analysis of the manner in which the EU has influenced the Maltese health system and attempt to shed light on the normative dimension of health system Europeanisation.(44)

METHODS

Design This qualitative study used information collected from face-to-face interviews to assess participants’ perceptions of the development of the Maltese health system within a European context. Permission to conduct this study was obtained from the University Research Ethics Committee at the University of Malta. The reporting of the study closely followed the COREQ criteria.(45)

Study Participants and SettingParticipants were recruited purposely with the principal inclusion criterion being the role they held in the health system or in European affairs over several years, such that they were already involved at the time of Malta’s accession to the European Union. Thereafter, they remained closely involved in decision making at the Malta–EU interface for a certain period. Therefore, the sample included senior public officers from the Ministries of Health and European Affairs, politicians, senior clinicians and leaders of civil society (Table 4.1). Thirty-five suitable participants were invited by the principal investigator and informed about the study. The voluntary nature of their participation was emphasised and precautions were taken to safeguard anonymity. Two persons declined to participate, citing lack of sufficient knowledge of the subject. Written informed consent was obtained from all participants before the start of every interview. All interviews were carried out only by the principal investigator and in English3. Interviews were face-to-face in a location selected by the interviewee. Participants were informed that, through each

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interviewee’s personal unique experience, the scope of the interview was to contribute towards the construction of knowledge of how the Maltese health system was affected by EU membership. The interviews were audio recorded and transcribed verbatim.

Table 4.1 - Professional roles of participants interviewedRole Number of participantsEuropean affairs public officer 4Ministry of Health (MoH) public officer 13Politician 5Academic 3Clinician 3Civil society 5Total 33

Interview guideA semi-structured interview guide was developed from the literature on Europeanisation and small states and was reviewed by experts in public health, European studies and small state studies. Using this semi-structured interview approach ensured a fixed core of themes and allowed sufficient flexibility to digress and explore themes that emerged during the interviews. The themes in the interview included the following: participants’ experiences and views on the health policy-making process in Malta, examples of areas that changed as a result of EU membership, consequences for the health system associated with EU membership, the balance of competence between European and national policy making in the health sector, institutions and mechanisms through which the EU influences the health system and reflections on Malta’s size and implications for the policy-making process at the national and European levels. Further probing was carried out using supplementary questions primarily tailored to the background of the individual interviewee.

Data analysisAn inductive approach was used to carry out the data analysis. Nvivo® 10 was used to support the coding process. To strengthen the validity of the data, the first five interviews were coded by three researchers to establish coherence and consistency. Subsequently, the remaining interviews were each coded by two researchers. The coding team consisted of the principal investigator and two researchers from Maastricht University distant to the Maltese health system. Additional codes were continuously added throughout the remainder of the analysis to preserve the richness of the data, bearing in mind that different stakeholders often emerged with unique perspectives. The list of codes that emerged was used to generate saturated clusters, categories and broader dimensions and themes.



Researchers compared their interpretation of the codes and divergences were discussed until consensus was achieved. The codes were grouped into categories from which key themes were identified. When determining the labelling of the codes and the categories, care was taken to preserve the original verbatim extracts of the study’s participants to ensure that their ‘voices’ remained visible throughout the research process.(46) Because the study aimed to highlight the normative dimension of the Europeanisation of the health system, this technique enhanced the authenticity of the data. Care was taken to emphasise the main points of consensus and convergence amongst the interviewees whilst also highlighting deviant views and unique contributions, where appropriate, to reflect the complexity that emerged from the stakeholder contributions.(47)

RESULTS

Thirty-three in-depth interviews were conducted with domestic actors during July and August 2014. The interviews were approximately 45 minutes and the total interviewing time was 23 hours. Four major themes are identified and presented as a process, with each stage influencing the subsequent one (Figure 4.1), in line with the research questions previously specified. The first theme represents the EU accession process and what EU membership signified in general terms. The second theme presents the specific effects of EU membership on the domestic health system. In the third theme, stakeholder attitudes towards the EU are depicted. The final theme presents stakeholder expectations regarding future health system Europeanisation. These four themes are analysed using supporting evidence from the data.

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101

General reflections on a decade of EU membership

The general consensus is that the net effect of EU membership has been ‘definitely’ (#25

politician) and ‘undoubtedly’ (#27 MoH public officer) beneficial, as illustrated through the

following quote.

‘Today’s citizen is more empowered; today’s citizen has more rights; today’s citizen in Malta

benefits from much higher standards than he did or she did ten years ago, and that also holds

in the area of health. So, whether it is the quality of the pharmaceuticals, the cross-border

directive or freedom of movement and the level of specialization of the professionals who take

care of the patients… I think there have been huge strides forward!’ (#18 politician)

For public officers, the following important positive developments in the policy-making

process are attributed to EU integration: a greater degree of transparency, a more structured

consultation process, enhanced inter-sectoral cooperation and the requirement to consider the

budgetary impact of the policies. Target setting is believed to have become more common, with an

enhanced degree of accountability and a ‘better sense of discipline’ (#27 MoH public officer) also

characterising the policy-making process.

Future health system Europeanisastion Greater role in public health Capacity Enhancement Flexibility Respect for subsidiarity

Stakeholder attitudes towards the EUGratitude Positive perceptions Disappointment Euroscepticism

Effect on domestic health systemTransformation InertiaAdaptation Retrenchment

EU membershipExternal force for reform Opportunities Challenges Burden

Figure 4.1 The process of Europeanisation in the Maltese health system Figure 4.1 - The process of Europeanisation in the Maltese health system

General reflections on a decade of EU membershipThe general consensus is that the net effect of EU membership has been ‘definitely’ (#25 politician) and ‘undoubtedly’ (#27 MoH public officer) beneficial, as illustrated through the following quote.

‘Today’s citizen is more empowered; today’s citizen has more rights; today’s citizen in Malta benefits from much higher standards than he did or she did ten years ago, and that also holds in the area of health. So, whether it is the quality of the pharmaceuticals, the cross-border directive or freedom of movement and the level of specialization of the professionals who take care of the patients… I think there have been huge strides forward!’ (#18 politician)

For public officers, the following important positive developments in the policy-making process are attributed to EU integration: a greater degree of transparency, a more structured consultation process, enhanced inter-sectoral cooperation and the requirement to consider the budgetary impact of the policies. Target setting is believed to have become more common, with an enhanced degree of accountability and a ‘better sense of discipline’ (#27 MoH public officer) also characterising the policy-making process.

The majority of interviewees believe that the obligation to comply with EU rules was important for certain sectors in Malta to ‘evolve’ (#7 MoH public officer). Stakeholders describe EU membership as ‘being part of a family’ (#3 politician) or ‘a community which has its eyes on us’ (#1 academic). This external scrutiny is deemed important to introduce norms



and appropriate behaviour for policy makers. This benefit of having ‘checks and balances’ (#3 politician) in the policy-making process is described as a significant impact of Malta’s EU membership.

‘Securing independence is one thing, but setting up the institutions, introducing checks and balances is most essential and I think, perhaps, this is the gift of the European Union to us’ (#4 clinician).

The external pressure brought to bear by the EU assisted politicians to overcome barriers and ‘face politically difficult decisions’ (#18 politician), often forcing them to do things they would not have done because of competing priorities. The accession process is described as a ‘golden period’ (#1 academic) and a ‘catalyst’ (#29 MoH public officer), bringing about rapid changes and the establishment of standards.

‘What the European Union has helped us to do is to actually achieve a lot in a very short period of time, and thankfully, it was that way because otherwise we would probably have not succeeded’ (#11 civil society).

However, the accession process also brought enormous challenges for the small administration, and a public officer described the situation as, ‘really swimming against the current’ (#13 MoH public officer). A lack of capacity to meet EU requirements (or norms) and the administrative burden associated with excessive bureaucracy are two main challenges that most interviewees identified. The administrative burden is the ‘price to pay’ (#18 politician) for becoming a member of the EU and a key challenge is the shock of having to adapt from being an organisation with an absent documentation culture to becoming part of a system in which documentation plays a key role. This increased workload and burden associated with answering questionnaires or attending meetings is negatively perceived as taking up valuable time that could be better spent working on the core public health business. This lack of capacity to keep up with EU demands also affects civil society.

‘It is hard to keep up with the changes because when you feel that you have come home with the transposition of one EU directive, there will be other directives in the making, opinions, positions, green papers, papers of all the colours under the rainbow’ (#15 civil society).

Effect of EU membership on the domestic health system The reform of the pharmaceutical sector and the development of regulations for specialist health care professional qualifications are believed to be the most important health

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system domains that were transformed as a result of EU membership. EU membership provided an opportunity to overhaul and modernise the legislative framework for public health regulation, including communicable disease control, food safety and environmental health, which were all significantly strengthened through institution building. These sectors are all subject to comprehensive legislation at the EU level that had to be transposed and implemented in the domestic health system.

‘There are three or four sectors which were completely revolutionised since we joined [the EU] medicines, healthcare professionals or rather how they are regulated, food safety, public health issues…’ (#10 MoH public officer).

Some stakeholders point out the important impact on specific services and mentioned ‘cancer screening services’ (#21 MoH public officer) and ‘major, major improvement in the blood transfusion services’ (#20 civil society). These areas were also the subject of an EU recommendation and directive, respectively. However, stakeholders have mixed feelings about the effectiveness of non-binding recommendations as effective mechanisms for implementing change because–in the area of patient safety–insufficient improvement is considered to have occurred. In line with this observation, whilst interviewees hold divergent views regarding the extent to which EU integration affected the actual organisation of health services, the overall perception is that health system financing and delivery has mostly been unaffected.

‘I don’t’ think it has made much of a difference really. Healthcare as such hasn’t changed-the actual provision of healthcare, the quality, the timing or the delivery of the service–I think all that hasn’t changed at all’ (#23 clinician).

The lack of a legislative EU obligation in certain health services is considered a missed opportunity for introducing a much-needed reform. In primary care, no significant reforms were implemented other than the specialist training programmes for general practitioners, which is a mandatory EU requirement. An ambitious reform proposal for primary care failed after encountering stiff stakeholder resistance. For some interviewees, this reform failure in primary care is partly attributed to the lack of an EU-driven obligation.

‘I think if there was some sort of directive, or recommendation, or opinion, or strong push from Europe, it would help us to push things forward in primary care’ (#2 MoH public officer).



However, public officers do not view the EU influence as being limited to areas in which a legislative obligation exists. They perceive a more indirect and ubiquitous influence on various aspects of the health policy-making process itself, with the formulation of public health strategies in areas such as sexual health and non- communicable diseases being attributed to indirect influence of the EU. The number of health strategies launched is reported to have increased markedly following EU membership4. Public officers feel that they were ‘pushed’ (#17 MoH public officer) by the EU to develop a national health strategy. They describe how the need for such a strategy has long been identified by the public health community but was only accepted as a priority by the political class when it became a conditionality to access European funding5. Other specific benefits for the health system resulted from the use of EU funds. Constructing and equipping an oncology hospital and the training and development of health professionals are important examples of health system development and service transformations that were made possible through EU funding.

Not all effects of the EU on the domestic health system are positively regarded. Compliance with the working time directive is a major health system challenge through which stakeholders believe that the EU demonstrates a lack of understanding of the specificities associated with running a small health system. Participants expressed their concern that removing the opt-out clause that allows workers to exceed 48 hours weekly would mean that ‘health services would collapse’ (#20 civil society).

A second major health system challenge identified refers to the reform of the pharmaceutical sector. Although interviewees acknowledge the benefits of increased consumer protection as a result of the implementation of EU law on the quality, safety and efficacy of medicines, they describe serious concerns about the decrease in the availability of medicines in the market and price increases following EU accession. Stakeholders question whether the regulatory regime adopted was ‘too draconian’ (#18 politician) for such a small health system and whether a more efficient system could have been considered.

Stakeholders expressed mixed views about the cross-border directive. Although it is too early to judge the overall effect, some believe that the directive has unrealistically raised patients’ expectations, thereby posing a potentially serious challenge for the health system. Others play down its significance.

A public officer knowledgeable about the EU fiscal governance regime registered her grave concern about the increased EU focus on the financial sustainability of health systems. She questioned whether domestic policy makers would be able to continue to resist pressures to implement changes to the health services system provided free of charge at the point of use.

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‘From the financial point of view, from the budgetary point of view, the EU is focusing more on the sustainability of our health system, and I think that will be the major challenge in the years to come’ (#33 EU Affairs public officer).

During the first decade of EU membership, the Maltese health system has undergone several changes through an array of EU mechanisms. Public health and those sectors for which the EU has legislative competence through its internal market legislation were particularly affected (Table 4.2). However, core health system elements, including the financing and organising of services, remained largely unchanged (Table 4.3).

A minority of stakeholders are of the opinion that the changes observed in the Maltese health system would have happened anyway, but that EU integration hastened the implementation of the reforms. A small number of stakeholders questioned whether the role of the EU in influencing health system development is overstated and suggested alternative explanations, such as national political priorities, globalisation, a neoliberal agenda, access to information from the Internet and the role of the World Health Organisation, as other important drivers for health system reform.



Table 4.2 - Health system transformation and adaptation (Malta 2004-2014)Health System Change

Description Europeanisation Mechanisms AnalysisPublic health policies and strategies

Transformation Non-binding EU communications, strategies, reports

Participation in EU working groups

Domestic health policy-making process underwent significant change and a number of important health strategies were developed

Cancer Transformation Non-binding EU Council Recommendation on Cancer Screening

EU Funds for hospital, equipment and capacity building

Participation in EU Joint Actions and networks

Submission of health information statistics

Services in the area of cancer have been transformed through the development of a national plan, cancer screening services, training of health professionals and the constructions of a new oncology hospital

Development of specialist training programmes for doctors

Transformation Directive

EU funds for capacity building

Legislative framework, establishment of medical specialist registers, structured post graduate training

Regulation of quality, safety and efficacy of medicines

Transformation Directives

EU funds for capacity building

Participation in networks and working groups

Transposition of legislation and setting up of the competent authority to regulate the placing of medicines on the market

Establishment of regulatory institutions with separation of regulatory and provider roles

Adaptation Directives

Participation in networks and working groups

Transposition of legislation and setting up of competent authorities for licensing providers and regulating public health standards

Health statistics Adaptation Participation in networks and working groups

Benchmarking

(EUROSTAT regulations recently entered into force)

A good health information system was already in place prior to accession but EU legislation, policy and networking helped to strengthen it

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Table 4.3 - Inertia and resistance to health system reform (Malta 2004-2014)Health System Continuity

Description Europeanisation Mechanism AnalysisPrimary care Inertia Directive (on

training of general practitioners)

The necessary changes were implemented to the specialist training for general practitioners but otherwise no significant changes were reported and the planned 2009 reform was not implemented

Patient safety Inertia Non-binding EU Council Recommendation on Patient Safety

Reports on the implementation of patient safety indicate that the Maltese health system has not made any significant advances on this aspect

Cross border care Inertia Directive Transposition of minimal requirements of the directive

Pricing and reimbursement

Inertia Directive Minimum requirements of the transparency directive on medicines were transposed but no major changes to the system of pricing or reimbursement were implemented

Working time Retrenchment Directive Extensive use of the ‘opt-out’ clause for doctors agreeing to work more than 48 hours weekly so as to avoid major changes to the system

Funding of public health care

Retrenchment Country specific recommendations emerging from EU fiscal and economic governance mechanisms

Despite health system sustainability being repeatedly mentioned in several annual reports the model of health financing has been strongly protected by successive Governments

Domestic health system stakeholder attitudes towards EU integration A range of domestic health system attitudes towards EU integration are identified with the overall perception being a positive one despite the burden connected with a disproportionate bureaucracy on the small administration.

‘Thank God that there is an obligation, so thank God for the EU!’ (#21 EU affairs public officer).

This extract captures the sense of gratitude that several stakeholders associate with EU integration. Positive attitudes towards EU integration stem from various perceived benefits. Access to knowledge and information obtained from other MSs, which avoids



the need to ‘reinvent the wheel’ (#1 academic) and the concept of ‘riding the EU bandwagon’ (#7 MoH health public officer) in carrying out joint assessment work in medicines are important examples of mechanisms that alleviate the administrative burden. Capacity building and European peer networking are viewed as instrumental to overcoming the loneliness and professional isolation associated with working in policy and regulation in a small island. EU membership has facilitated international networking at the clinical level, which indirectly serves to raise healthcare standards and improve morale and self-confidence amongst clinicians. Networking is also described by civil society representatives seeking to promote their members’ interests at the EU level as having increased in importance. In addition to networking, the importance of access to technical assistance and specialised expertise is highly valued. The European Centre for Disease Control (ECDC) is an important source of support for the domestic public health workforce.

‘ECDC has given us very important support. For example, it brings a group of experts together and they develop guidelines. So, for us, that is very good because we don’t have such a wide pool of expertise. We have 24-hour communication with ECDC and it is not the first time that they carried out assessments, even specifically for us. Last year we had Q fever. It was the first case that we actually came across in the last few years and we wanted guidance. ECDC actually carried out an assessment for us. We have reassurance that we have someone to turn to’ (#6 MoH public officer).

However, despite these positive examples, several stakeholders believe that ‘The approach of the EU to health …is disappointing’ (#6 MoH public officer). Disappointment is a result of the lack of priority accorded to health at the EU level. Health ministers are viewed as being weak in relation to their finance counterparts. Poor budgetary allocations and the limited power of the Commission Directorate General responsible for health are viewed as resulting in a weak stand when confronting multi-national lobbies. The tobacco and food industries raise a particular concern. Another key source of disappointment is the ‘one size fits all’ approach, which belies a lack of understanding of the specific challenges faced by MSs given their geo-demographic or socio-economic profiles.

‘Most of the people who are taking the decisions in Brussels come from large countries and they may not perceive what our problems are. For example, one maternal death is sufficient to screw up your data…’ (#26 clinician).

Specifically, public officers and academics expressed their disappointment and frustration at being unable to tap into EU funds to develop local research capacity, with EU funds invariably going to centres in larger countries in which cutting-edge research

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is taking place. A politician who expressed his belief that ‘there are funds provided you apply in a diligent way and abide by the rules’ (#19 politician) dissented starkly from the general consensus. The co-funding element, lack of capacity and administrative bureaucracy are all listed as key barriers to accessing EU research funds. Small states’ particular needs are also believed to be often overlooked in impact assessments. Whilst a couple of initiatives to lighten the burden exist in the pharmaceutical sector, they are deemed to fall far short of addressing small state specificities and are viewed as providing an exceptional ‘way out instead of having an infrastructure which is friendly to small member states’ (#31 EU affairs public officer).

An interviewee with extensive experience in technical meetings uniquely stated that his requests about small size issues ‘are typically then taken on board, although to varying extents’ (#17 MoH public officer), thereby illustrating the importance of intervening early in the initial technical stages to maximise influence.

Disappointment is also related to a series of unmet expectations, foremost amongst which is the lack of EU engagement and support related to the problems posed by immigration.

‘The biggest disappointment, not just in healthcare but for the whole Maltese population although it also is important for healthcare, is the failure of the EU to engage with immigration’ (#4 clinician).

The gap between rhetoric and documentation produced at the EU level and tangible change at the operational level, lack of continuity between EU Presidencies and inability to ensure effective enforcement are other examples of work being carried out at the EU level but that is not making the desired impact at the domestic level.

‘Decisions are taken at the very top by the ministers but the problem mainly is whether they seep down and are actually implemented at the operational level. There is a huge gap’ (#30 MoH public officer).

Amongst some public servants, disappointment associated with unmet expectations coupled with fatigue from the struggle to cope with daily EU pressures appears to be leading to Euroscepticism.

Expectations regarding future health system EuropeanisationThe role that the EU should play in public health policy and health systems is contentious. Some stakeholders state that ‘people want subsidiarity to stay, they want to run their own system’ (#20 civil society), whereas others express a desire for a greater degree of EU involvement.



Even those participants who agree with a greater role for the EU acknowledge the sensitivity that exists around the principle of subsidiarity and the problem of the existing diversity of European health systems that prevent the EU from assuming a larger role.

‘Let’s imagine that reforms in primary healthcare will be driven at the EU level across Europe, let’s dream about that! But then again you cannot really have the ‘one size fits all’ because that would result in chaos because really, you can’t standardize practices like that’ (#1 academic).

Growing Euroscepticism and the increasing fiscal and economic orientation being taken by EU institutions are believed to be contributing to heightened tension between Europeanists and pro-autonomy forces.

‘There are two schools of thought, those who think that the European Union should exercise greater control possibly from Brussels versus those who want more space for Member States to decide for themselves. Although these divisions have always existed in the European Union, I think that they will now become more prevalent’ (#24 MoH public officer).

The following phrase captures the general feeling amongst most interviewees: ‘it would be more beneficial that Member States are actually doing more together rather than the opposite’ (#8 EU Affairs public officer). Several policy areas in which a greater role for the EU is deemed both desirable and feasible are identified. Foremost amongst these areas is the issue of access to affordable medicines. Since the financial crisis, the issue of affordability of medicines and attention to pricing has been noted to be no longer only of concern to small or poor countries but also has affected MSs, which was hitherto unaffected by it. Action at the EU level can counteract the limitations associated with a small market size.

‘Most Member States are now facing sustainability and pricing issues, so I guess, the EU through better cooperation, could help them face these challenges jointly’ (#31 EU affairs public officer).

Several interviewees feel that the EU should play a more active role in the prevention and control of non-communicable disease, with obesity, diabetes and tobacco control considered as key priorities.

‘If I had to pinpoint one area where the EU could come together more effectively is in the major non-communicable diseases to make sure that what is being done at national level in twenty-eight different countries, is shared, brought together and supplemented at EU level

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to make sure that we get the best results faster and translated into more effective remedies that can be shared by all patients affected across the EU’ (#18 politician).

The introduction of a basic level of care and a standard health care package across the EU, as well as standards for primary care, are considered important future developments for EU health policy by domestic stakeholders. The adoption of minimum standards of training and qualifications for specialist nurses, for allied health care professionals and for carers is considered a priority. A few interviewees expressed their desire for the EU to play a larger role in quality and patient safety. Some interviewees see the need for the EU to take a more active role in developing health information systems. Voluntary mechanisms, such as using enhanced cooperation procedures, are proposed as methods to implement such measures to ensure flexibility and avoid the much maligned ‘one size fits all’ approach.

In keeping with the general desire for the EU to play a larger and more visible role, most interviewees do not believe that excessive involvement or undue influence of the EU exists on the Maltese health system. The notable exception is the perceived EU influence on curbing public health care expenditures, which is unequivocally deemed as a threat by all stakeholder groups. The EU’s pressure to curb health sector expenditures is believed to reflect an insufficient understanding of the domestic health system context and that negative consequences for the health system could result from such approaches. A public officer strongly expressed his view that it is very important to defend the principle of retention of a health service that is free of charge at the point of use.

‘My feeling was that the Commission was trying to exert a bit too much influence and the worst thing about it was that the people making those suggestions or making those statements were coming from economical background. So, if I may daresay, their recommendation does not only belie certain ignorance of the local context, but also of basic public healthcare principles’ (#17 MoH public officer).

Although some clinicians feel that the EU should play a role in setting down basic care standards, others hold that this role should remain within the remit of scientific bodies and that European Institutions should not attempt to replace scientific guidelines with bureaucratic ones. Regarding human resource planning and deployment, public officers and civil society representatives hold divergent views on the extent to which national control on decision making should be retained; however, one participant described mandatory staff patient ratios at the EU level as a ‘no-go situation’ (#13 MoH public officer).

Interviewees recognise the need for the EU to coordinate between the different MSs and acknowledge the support provided, particularly by ECDC in the area of



communicable disease control. However, a detailed approach should be elaborated on at the MS level and the EU should refrain from taking up roles that are already suitably catered for by other organisations, such as the World Health Organisation (WHO).

‘I think that the Commission is there to coordinate what happens across EU but then it is up to individual Member States to manage their response because each Member State has different capacities, different limitations and different cultures’ (#6 MoH official).

Finally, religiously inspired values, including issues concerning reproductive health and abortion in particular, are an important unique theme for Maltese stakeholders. Any attempt by the EU to set policy would be strongly resisted.

DISCUSSION

Summary of key findingsFigure 4.1 illustrates how the process of health system Europeanisation is perceived to have occurred in Malta. The accession process provided a unique opportunity for health system reform, particularly in the area of medicines and professional training. However, other aspects of the health system, including the mechanisms of financing and delivery, were unaffected. Stakeholders positively view the EU as offering important support through technical and financial assistance and capacity building as well as in overcoming local sources of resistance to change. Negative attitudes are associated with administrative burdens and conflicting values. Overall, domestic stakeholders in the Maltese health system are positive over the EU influence on their health system and desire greater EU involvement in health policy as long as the influence is flexible enough to take into account small state specificities.

Health system Europeanisation in practiceTables 4.2 and 4.3 show how the degree of Europeanisation within the Maltese health system has varied amongst the different health system domains. Where Europeanisation has occurred, it has been done through diverse mechanisms–confirming that both regulatory compliance and social learning play a role in the Europeanisation process.(44) The window of opportunity to implement reforms provided by the EU accession process and described in this study confirms the findings from the literature in other sectors.(48-50) The highest adaptation pressures were experienced in the pharmaceutical sector and mutual recognition of professional qualifications, including medical specialist training. This finding is not surprising given that the principle of free movement underpinning these sectors is a foundational EU policy and both areas were highlighted as being

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impacted in pre-accession assessments of candidate countries, including Malta.(51-56) The impact on the pharmaceutical sector in Malta was also previously described.(57) Malta did not experience public health reforms associated with accession on the same scale as that reported in other countries and the health services’ core elements appear to have remained mostly unaffected.(58) For some stakeholders, this phenomenon represented a missed opportunity to bring about change and is most evident in the area of primary care. In primary care, a series of proposals for reform failed to materialize and stakeholders appear to believe that an EU obligation would most likely have provided the necessary impetus for reforms to be implemented.(59)

Therefore, this study established that, to date, the dominant focus for health services organisation and delivery resides at the national level. However, Hervey’s observation that the influence of the EU permeates ‘virtually every aspect of such [health] policies’ also receives support from our findings because the EU appears to be exerting an indirect effect on health policy making by stimulating the production of several national health strategies.(5)

A manifest implementation gap between what is decided at the EU level and the effect within the health system emerged as an important critique of the effectiveness of Europeanisation in practice. This consideration is important because health policy is governed to a large extent through soft law, which, although considered to play an important role our findings indicate has mixed effects.(27),(60) For example, stakeholders describe the implementation of the recommendation on cancer screening as a success but the implementation of the recommendation on patient safety as poor. The effectiveness of implementation has been found to vary among countries and small states must often prioritise because of their limited capacity.(61-63) In these circumstances is it not surprising that non-mandatory initiatives assume a lower priority. Furthermore, the existence of strong veto players is likely to affect the ability of governments to implement non-binding recommendations.

A small state perspective on health system EuropeanisationA survey of European health stakeholders found mixed perceptions of whether or not role expansion should occur for the EU in health policy.(6) A study carried out in the United Kingdom on the balance of competence between the EU and MSs in the field of health policy concluded that the balance is ‘broadly right’.(64) Stakeholders from our study in the Maltese setting demonstrate support for further EU involvement in certain areas in which action at the level of a small state is deemed insufficient to achieve the desirable public health results. Therefore, the expansionist stakeholder attitudes towards future EU health policy observed in this study can partly be explained as being a result of the special characteristics of small states. Small states benefit disproportionately from the



existence of effective regional organisations and ‘soft’ security aspects, including public health, have been described amongst such benefits.(65-66) For example, the literature on the value of ECDC is mixed. Some hail this institution as a policy success whereas others question its ability to fulfil its mission because of its heavy reliance on country experts.(6-7),(67) Our study found that Maltese health system stakeholders are strongly positive about the role played by the ECDC. Therefore, discussions on the future role for ECDC should also consider the benefits that accrue to small MSs. Networking as a means of overcoming professional isolation emerged as a substantial benefit for domestic stakeholders. Furthermore, the emerging global interdependence of public health makes it even more pressing for small states to acquire the protection and shelter of a regional organisation to defend public health interests.(66,68) This study revealed a desire for the EU to play a larger role in ensuring access to affordable medicines, a key issue for the small domestic market. The Joint Procurement Agreement on medical countermeasures for cross border health threats and the setting up of an expert working group on safe and timely access to medicines are examples of policy initiatives that have been championed by small states.(69-70)

However, the desire for a larger EU role in health systems is offset by stakeholder disappointment with the lack of understanding of specificities related to the geo-demographic profile of Malta. Although the literature has traditionally portrayed the Commission as being an ally for small states, our study found that this portrayal is not always the case.(62),(71) A potential explanation is that many key decision makers in EU institutions hail from larger countries. The ‘one size fits all’ approach appears to have created problems in the implementation of the working time directive, aspects of the pharmaceutical Acquis and in access to research funding.(72) The lack of public health research in small states has been described elsewhere and the findings from this study serve to confirm that this lack of research remains a particular challenge for small states.(73-76)

Critique of Europeanisation theoryThe typical dilemma of establishing causality in Europeanisation research emerges in this study.(77) One may question whether the role of EU integration as a catalyst for reform is overstated and whether change could equally have resulted from other influences.(78) The broad consensus amongst stakeholders interviewed is that beyond the necessity of regulatory compliance–markedly associated with the accession process–the overall on-going change attributed to EU influence within the health system is brought about primarily through networking. This consensus concurs with the concept of socialisation and social learning as vehicles for Europeanisation as described in the social constructivist model.(29),(44) In these circumstances in which no EU regulation

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or directive exists as a point of reference, it becomes far more difficult to determine how much of the observed change is driven by the EU as opposed to other forces resulting from economic globalisation or neoliberalism.

Strengths and limitationsThis study is innovative and attempts to cover a broad scope. Efforts were undertaken to ensure reflexivity through the research process.(47) The core research team consisted of three individuals, two PhD students with previous public health research experience and one post-doc researcher with public health practice and experience in qualitative research methodologies. The principal investigator is based in the Maltese health system and the collaborating researchers are in The Netherlands. Their different locations allowed in-depth contextual knowledge to be complemented by external assessment and provided a forum for reflecting on the study design and analysis, and to critically question the process at all stages. The principal investigator previously occupied senior positions within the Ministry of Health in Malta, including responsibility for European and international affairs. The motivation for this research stemmed from an interest in investigating the impact of EU membership on the health system in Malta. All participants were recruited through the professional network of the principal investigator who did not share her own opinion until the interview was complete, even when this opinion was requested by the interviewee because the perception of the interviewee was the main focus of the interview.(79) Despite all of the steps taken to assure quality, this study has certain limitations. This study provides a picture of the situation through the lens of domestic stakeholders at a single point in time and focuses particularly on a number of issues related to Malta. Thus, the findings may not necessarily transfer to other contexts, and further research is necessary to determine whether other small countries face similar challenges. Additionally, complementary approaches using different techniques, such as process tracing, may be performed in the future to validate the findings and to strive to overcome the limitations previously described in establishing causality. Nevertheless, this study contributes important innovative perspectives on European health policy, and further research amongst domestic stakeholders in other Member States is recommended.

CONCLUSIONS

Establishing causality is a dilemma for researchers in the field of Europeanisation. Yet, the findings from this study appear sufficiently strong to indicate that domestic stakeholders believe that Malta’s integration into the EU provided an external drive for certain reforms to be implemented. Public health policies appear to be affected more by EU policy than health care services. A policy infrastructure that is ‘friendly’ to small Member States



is deemed preferable to the creation of specific exceptions. We found evidence of both ‘passive downloading’ of EU regulations and ‘active usage’ of EU rules to promote the desired norms and objectives. Although the health sector is a peripheral policy area for the EU, merit exists in using Europeanisation as a concept to better understand the evolution of this policy area in the EU. Obtaining a deeper understanding of the interaction between the EU institutions and MSs and the tension between, on the one hand, the desire for a larger EU mandate and, on the other hand, the safeguarding of subsidiarity is critical. This understanding is particularly relevant in view of the current context in which health systems are being increasingly framed in terms of financial and economic considerations with the potential marginalisation of public health from the policy objectives at the EU level.

We conclude that domestic health system actors in Malta generally share a positive assessment of the overall impact of EU membership on the health system and support a larger role for the EU in several policy areas. This support is generated from positive experiences, from a sense of disappointment that not enough is being done at the EU level to promote public health and from a desire that the EU provides support to overcome domestic health system problems linked to small market size. At the EU level, the financial crisis and ensuing effects on several health systems may provide an important opportunity to alter the propensity of at least some Member States to engage in more intensive health system cooperation. This study, by providing a small state perspective to health system Europeanisation, challenges the traditional narrative that Member States do not see a need for deeper integration in the field of health policy. What would be interesting to establish in this context is whether this need for deeper integration is felt by all states or whether it is felt more intensely by smaller states that lack sufficient resources, knowledge and policy initiatives but benefit from uploading their problems to the EU level or finding additional resources that they individually lack. Therefore, this study sets the scene for broadening the analysis to other small states to ascertain whether our findings are uniquely applicable to Malta or to small EU member states in general. However, other interesting possibilities exist that arise from our study, including the question: do larger states face similar challenges and dilemmas in their health systems at regional and local levels and would our findings and arguments apply equally to them?

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I The European Semester an EU-level policy co-ordination tool contributing towards the broader EU aims of strengthening economic governance and greater policy co-ordination. It provides a more integrated surveillance framework for the implementation of fiscal policies under the Stability and Growth Pact as well as the implementation of structural reforms through national reform programmes. The Commission publishes Country-Specific Recommendations for each Member State based on a thorough assessment of every Member State’s plans for sound public finances and policy measures to boost growth and jobs. For further information the reader is referred to http://ec.europa.eu/europe2020/making-it-happen/index_en.htm [accessed on 6 September 2015]

II For a comprehensive yet simple introduction to Europeanisation theories, the reader is referred to Harwood Mark, Chapter 3 Europeanisation in Malta in the European Union Ashgate Publishing 2014.

III English is an official language in the Republic of Malta

IV The main health strategies published in the period following accession are listed in Chapter 6 of the Health Care Systems in Transition Report for Malta which is available at http://www.euro.who.int/en/about-us/partners/observatory/publications/health-system-reviews-hits/full-list-of-country-hits/malta-hit-2014 [accessed on 10/09/15]

V The European Commission issued guidance on a number of conditionalities that need to be fulfilled for access to the European Structural and Investment Funds 2014-2020. In the area of health, the existence of a strategic plan for the health system is one such criterion. Further information is available at http://ec.europa.eu/regional_policy/index.cfm/en/information/legislation/guidance/ [accessed on 6 September 2015]



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CHAPTER 5The impact of the EU Directive on Patients’ Rights

and Cross-border Health Care in Malta

Azzopardi-Muscat N., Aluttis C., Sorensen K., Pace R., Brand H. The impact of the EU Directive on patients’ rights and cross border health care in Malta

Published in Health Policy 119(10) 1285-1292 October 2015 http://dx.doi.org/10.1016/j.healthpol.2015.08.015

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ABSTRACT

The patients’ rights and cross-border health care directive was implemented in Malta in 2013. Malta’s transposition of the directive used the discretionary elements allowable to retain national control on cross-border care to the fullest extent. This paper seeks to analyse the underlying dynamics of this directive on the Maltese health care system through the lens of key health system stakeholders. Thirty-three interviews were conducted. Qualitative content analysis of the interviews reveals six key themes: fear from the potential impact of increased patient mobility, strategies employed for damage control, opportunities exploited for health system reform, moderate enhancement of patients’ rights, negligible additional patient mobility and unforeseen health system reforms. The findings indicate that local stakeholders expected the directive to have significant negative effects and adopted measures to minimise these effects. In practice the directive has not affected patient mobility in Malta in the first months following its implementation. Government appears to have instrumentalised the implementation of the directive to implement certain reforms including legislation on patients’ rights, a health benefits package and compulsory indemnity insurance. Whilst the Maltese geo-demographic situation precludes automatic generalisation of the conclusions from this case study to other Member States, the findings serve to advance our understanding of the mechanisms through which European legislation on health services is influencing health systems, particularly in small EU Member States.

Key wordsCross-border health care, Patients’ rights, Europeanisation, Case study, Health policy, Malta,


The impact of the EU Directive on patients’ rights and Cross-border health care in Malta | 111

INTRODUCTION

The patients’ rights and cross-border health care directive is a landmark in European health care politics, yet its potential to lead to a widespread impact upon Member States’ (MS) health care systems is open to debate.(1-6) The directive deals with people seeking to go abroad for health care on their own initiative, as distinct from care that becomes necessary during a temporary visit, care sought by retirees in other countries, care sought across borders in border regions or people sent abroad for care organised by their home systems.(7)

Early non-exhaustive reviews of the implementation of the cross-border directive reveal mixed results.(8) Member States with systems that fit less well with EU legislation may be expected to experience larger adaptations.(9-10) Member States with National Health Service type systems would have to undergo more significant changes in order to align their health care systems with the requirements of the cross-border care directive.(11-13) The impact assessment of the Commission’s proposal for a directive had highlighted the fact that small MS are likely to face a greater financial impact as a result of cross-border care.(8,14)

In Malta cross-border patient care is mainly based on structured cooperation agreements with the United Kingdom and specific Italian regions.(15-16) In 2013, 423 patients received organised care overseas, approximately 0.1% of the population.(17) Studies of patient experiences in the national overseas highly specialised care programme have overall revealed a high level of satisfaction and the need for an additional type of patient mobility may therefore not feature highly in the Maltese population.(18-19)

This paper seeks to illustrate how Europeanisation of health care is taking place in a small island EU Member State using the example of the patients’ rights and cross border health care directive. Malta’s smallness, its ‘national health service’ type system and long-standing organised cross-border care provides an interesting case study on how the cross-border directive has impacted on its health system. Such case studies are useful for studying European policy processes and are applicable in the field of Europeanisation.(20-22) A brief description of the Maltese health system situates the empirical findings in the appropriate context (See Box 5.1).

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Malta acceded to the EU in 2004. It is the smallest MS in the EU with a population of 417,432 and a total land area of 315 km2. The publicly funded health care system is the key provider of health services. The private sector complements provision in particular in the area of primary care and ambulatory specialist care. The Ministry is responsible for setting policy and standards, for regulation of public and private health services as well as for funding and direct organisation and delivery of health care. The public health system is funded by general tax revenues. Total health expenditure was 8.7% of Malta’s GDP in 2012 of which public spending was only 5.6% of GDP. Sustainability of the health system has become identified as a key challenge and the Maltese health system has come under the scrutiny of the European Semester process. In 2013 and 2014 Malta has received Country Specific Recommendations (CSRs) calling for a comprehensive reform of the health system to improve the efficiency and sustainable use of available resources.

Box 5.1 - Key facts about the Maltese health care systemSource – Health Systems in Transition Vol. 16 No. 1 2014; Malta Health System Review available at https://www.ecoi.net/file_upload/1930_1421314107_hit-malta.pdf accessed on 08/03/2015

Prior to 2013, Government had not implemented the European Court of Justice Rulings on patient mobility and was found to be in breach of Law by the domestic judicial system.(23) The Health Act and the accompanying regulations on cross-border health care came into force on the 25th October 2013.(24-25) The directive presumes the existence of a clear benefits entitlement package as well as a system to determine exactly who is entitled to access cross-border care. The Health Act provides for a formal and transparent mechanism for the establishment of the benefits package as well as a publicly accessible register of treatments and services offered by the public health system. This can be considered as a response to a national Court Case regarding Government’s failure to approve public funding of overseas treatment for a joint kidney-pancreas transplant which Government lost case due to the lack of a publicly available health care benefits package.(23) The Health Act also introduces an explicit legal reference to patients’ rights for the first time in Malta. The detailed implementation of the directive occurs through the regulations on cross-border health care.(25) These regulations primarily establish the role and responsibility of the National Contact Point. Domestic private providers are categorically excluded from the scope of the regulations as is the reimbursement of travel and ancillary costs. Emphasis on the obligation to fulfil all clinical and administrative formalities that are used to establish access to services within the Maltese health care system is evident, such as the use of clinical protocols and the need to be referred through the general practitioner gatekeeping system. The regulations also stipulate the ability of the competent authority to limit access to cross-border care in circumstances where the continued provision of high quality domestic care without waste of resources could be threatened. All the provisions in the directive that are listed as possible justifications for a prior authorisation system appear in the Maltese cross-border regulations. The obligation for all health professionals to have appropriate indemnity insurance appears for the first time in Maltese legislation in the Indemnity Insurance Regulations.(26) The



implementation of obligatory indemnity insurance was considered to be an important and sensitive issue.(27-28) Previously, health care professionals were not required to have any form of indemnity insurance in the private sector and therefore this new provision introduced an additional cost for professionals which could be passed on to the patient. In a health care system where 35% of total expenditure takes place primarily through out-of-pocket payment in the private sector upward pressure on tariffs particularly in primary care may have an important impact.(29) Whilst Government employees were implicitly de facto covered, there was no official legal reference to such cover and the lack of legal certainty was an issue that had been previous raised by trade unions in the health sector.

METHODS

The theoretical framework adopted for this study is that of “Europeanisation” and the classic definition by Radaelli of Europeanisation as ‘a series of top-down and bottom-up processes affecting both formal and informal rules as well as procedures, policy paradigms, styles and shared beliefs and norms’ is applied.(30)

Content analysis of verbatim interview transcripts, obtained from thirty-three face-to-face interviews in July and August 2014, was undertaken. A maximal purposeful sampling approach was adopted in order to obtain the viewpoint of diverse health system stakeholders.(21) The sample consisted of senior leaders from public health, civil servants from the Ministries of Health and European Affairs, politicians, senior clinicians and leaders in civil society. The key inclusion criterion was that participants were either in a leadership position in the health care system or European affairs practitioners for several years. Participants were selected on the basis of the role they currently or previously held e.g. Minister, Director, Secretary of Trade Union. Table 5.1 provides a description of the interviewees’ professional background and primary role description. No gender and age disaggregation is given to reduce the risk of identification of the respondents given the small numbers of stakeholders who occupy key positions in the Maltese health care system.

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Table 5.1 - List of Interviewees by primary roleRole Number of interviewees

Academic 3Public health civil servant 13Politician 5Clinician 3European Affairs civil servant 4Industry 1Civil Society 4Total 33

Thirty-five participants were approached through an e-mail by the principal investigator. Two persons declined to participate stating that they did not feel they had the required expertise. Written informed consent for audio recording was obtained prior to the interviews. The questions were open-ended and asked about the interviewee’s beliefs, attitudes and experience regarding their experience of the impact of Malta’s EU membership upon the health care system. Further probing was used to gain additional insights on specific topics that respondents mentioned during the interview, including the implementation of the cross-border care directive. The interviews were audio recorded and transcribed in full. Each interview was coded in parallel by two persons following an inductive approach supported through QSR Nvivo 10. Codes were compared and discussed among the members of the research team while allowance was made for the continued creation of new codes. The stakeholders’ perceptions regarding the patients’ rights and cross-border directive and its impact on the domestic health system were explored through qualitative content analysis. Thick descriptions of the emerging themes including “cross-border” and “patients’ rights” were developed. Key word searches in the transcripts for “cross-border” and “patients’ rights” ensured that all relevant statements were identified. Discussion between the research team was carried out until consensus on the themes and their inter-relationships was reached. Permission to carry out this study was sought and obtained from the University Research Ethics Committee (UREC) at the University of Malta.

RESULTS

Seventy-nine “cross-border” and 103 “patients’ rights” references were identified in the transcripts. Figure 5.1 depicts the results of the study showing how the mechanism of Europeanisation in the form of implementing a directive led to three main impacts according to the interviewees: moderate enhancement of patients’ rights, negligible additional patient mobility and unforeseen reform in the domestic health care system.



Furthermore, it was possible to identify three main streams of perceptions of emotions and behaviours: fear of the potential impact of increased patient mobility, strategies employed for damage control and the exploitation of opportunities for domestic health system reform. These themes are presented in two main groups as the reported perceptions and behaviour triggered by the directive and the actual early impact of the directive as perceived by the interviewees.

133

Results

Seventy-nine “cross-border” and 103 “patients’ rights” references were identified in the

transcripts. Figure 5.1 depicts the results of the study showing how the mechanism of

Europeanisation in the form of implementing a directive led to three main impacts according to the

interviewees: moderate enhancement of patients’ rights, negligible additional patient mobility and

unforeseen reform in the domestic health care system. Furthermore, it was possible to identify three

main streams of perceptions of emotions and behaviours: fear of the potential impact of increased

patient mobility, strategies employed for damage control and the exploitation of opportunities for

domestic health system reform. These themes are presented in two main groups as the reported

perceptions and behaviour triggered by the directive and the actual early impact of the directive as

perceived by the interviewees.

Perceptions and behaviour triggered by the directive

Fear from the potential impact of increased patient mobility

All stakeholders groups, with the exception of civil society representatives, expressed fears

about the financial implications associated with the possibility of the directive leading many

patients to seek cross-border care. Lengthy waiting lists for cataracts and orthopaedic surgery were

the main factors cited for the expected patient exodus.

Europeanisation mechanism

Transposition and implementation of the

patients' rights and cross border care directive in Malta

Perceptions and behaviours

Fear from the potential impact of increased

patient mobility

Strategies employed for damage control

Opportunities exploited for health system reform

Early impact of the directive

Moderate enhancement of patients' rights

Negligible additional patient mobility

Unforseen health system reforms

Figure 5.1 - Impact of the patients’ rights and cross border care directive on the Maltese health system

Figure 5.1 - Impact of the patients’ rights and cross border care directive on the Maltese health system

Perceptions and behaviour triggered by the directive

Fear from the potential impact of increased patient mobilityAll stakeholders groups, with the exception of civil society representatives, expressed fears about the financial implications associated with the possibility of the directive leading many patients to seek cross-border care. Lengthy waiting lists for cataracts and orthopaedic surgery were the main factors cited for the expected patient exodus.

“The fear was that with our waiting lists- especially in things like cataracts and orthopaedic surgery, we might be facing an exodus of patients trying to make use of the Cross-Border Healthcare.” (P17 health civil servant)

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Other factors mentioned included the perceived better quality of care in larger Member States and the propensity of Maltese patients to seek care overseas. However several respondents readily equally acknowledged that this much-feared threat had actually not yet materialised and referred to it as a future challenge as exemplified below.

“I think we felt that this (the cross-border directive) could have been very challenging to us because we thought that it might lead to an increase in expenditure which would be difficult to cover given that the Maltese are very keen on going abroad, more than other EU citizens. This has not yet materialised but it was looked at with trepidation” (P4 clinician)

Fear regarding the outward mobility of health care professionals and the potential loss of patients manifesting specific diseases since the decrease in patient volume could have a subsequent negative impact on clinical expertise, was an important theme mentioned in the small country context.

“I think the big risk, in my opinion, is the outward mobility of expertise and loss of pathology” (P5 health civil servant)

On the other hand the potential influx of patients into the domestic health system was mentioned as a key concern by a minority of respondents.

“From a service provision side perspective, there is a possibility of seeing a surge of the patients who may use our healthcare system because it is reputed to be quite a good healthcare system.”(P24 health civil servant)

Strategies employed for damage control Civil servants dominantly contributed to the theme of “damage control” which appears to have prevailed as an established approach from the early days of lobbying efforts. Reportedly, attempts were made to modify the Commission’s proposal for the directive by, for example, ensuring that prior authorisation, not initially included in the proposal, was eventually inserted in the text.

“The way in which the cross border directive itself was starting to move, for example, first prior authorisation was not included and then eventually it did get into the text.” (P13 health civil servant)

This “damage control” behavioural approach to counteract the expected patient outflows is believed to have prevailed during the transposition and implementation process. Civil



servants attribute the application of such restrictions to the observation that no sudden patient outflows were actually experienced.

“I think the way it was transposed, the way it was applied locally – ensured that till now the expected exodus didn’t happen…..we have not been able to exploit cross-border health care but we have been more focussed on the damage control agenda at this point.” (P17 MoH civil servant)

Several civil society representatives report that Government carried out a minimalist, correct implementation without actively encouraging patients to make use of their rights as exemplified by the two excerpts below.

“The Government is trying to act according to the policy but actually not enforcing it, not encouraging them to seek cross border care and the public is not that fully aware to go search for these things” (P16 civil society)

“Hopefully we will soon have a full transposition in practice, because in theory, we have it, but in practice we have to see” (P19 politician)

Opportunities exploited for health system reformAll stakeholder groups generally perceive the directive as a turning point because Governments came under pressure from the EU to provide their citizens with good health care.

“The Cross Border Directive has basically got us to look into the way we provide health services.” (P21 European affairs practitioner)

Some civil servants and clinicians viewed the directive as an attempt by the European Commission to introduce a minimum level or standard of health care in all MS.

“Now, in the name of having the same standards everywhere, they (the European Commission) could introduce a minimum level or standard in all Member States.” (P7 health civil servant)

For several stakeholders the directive was perceived to be instrumental in introducing legislation which had been repeatedly postponed.

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“I think it is the Health Bill. We have just seen it happen. It had been, I don’t know how long for, but it was a Parliament point on their agenda, which had been postponed, but as soon as the Cross Border Healthcare Directive came into force, the bill was implemented.” (P28 civil society representative)

A public health civil servant also contended that the directive served as an impetus to enact legislation on the organisation and governance of the departments within the Ministry for Health.

“The healthcare act wouldn’t have been implemented if it were not for the cross-border directive. However not all the reforms in the Health Act were directly related to the Directive. I’d say that part of the content of the Health Act, is purely related to national matters for example, the organisational structure is not imposed by the EU. So the Health Act was pushed because of the EU Directive deadline but we managed to include strictly national issues” (P5 health civil servant)

Perceived impact of the implementation of the patients’ rights and cross border health directive

Unforeseen health system reformsGenerally civil society representatives felt that the cross-border directive raised awareness on the manner in which the EU can impact the health system.

“Civil society organisations think that the EU will never influence the way we think and give advice because of the famous myth that has been amplified and disseminated, that is, EU accession will not affect our national health system. But we know that due to the directive, policies, legislation, even guidelines – we will be affected. Now we have been feeling and living it especially after the implementation of the cross-border directive” (P28 civil society)

Amongst civil servants the reform of the entitlement system and the introduction of a health care package are mentioned as important indirect outcomes of the directive’s implementation. Entitlement became important for fear of having to refund someone for costly treatment overseas when that person was not even entitled to coverage under the Maltese health system.

“The entitlement issue became important because you have to determine who is entitled in Malta, and the health care package, where we started to determine what services we can offer clearly to our clients was introduced.” (P5 health civil servant)



The introduction of professional indemnity insurance where the directive is believed to have played a determining role in ensuring compulsory indemnity insurance for all health care professionals was mentioned as an important outcome by several stakeholders as captured in the excerpts below.

“The cross-border directive led us to the application of better standards, like the indemnity issue. We wouldn’t have introduced the Indemnity issue had there not been the EU directive for sure…” (P7 health civil servant)

“We had the success story of the professional indemnity coverage of professionals. We knew that it was a very small paragraph in the cross-border healthcare directive…as soon as we saw it we started working on it as an organisation.” (P28 civil society)

The directive reportedly created a greater awareness of medico-legal issues and according to a health civil servant acted as a powerful stimulus to provoke changes in practice such as in the prescription and dispensing of medicines where enforcement had been an outstanding problem.

For all stakeholder groups, the directive is considered as a force that will place pressure on the domestic health services and lead to tangible patient benefits, if properly applied, going farther than the original notion of laying down rules for patient mobility and having future effects on the Maltese health system as stated clearly by a politician. .

“My idea of the Cross-Border Directive is not so much the rights that it introduces in terms of people seeking treatment abroad but the inherent pressure on the local authorities to give a better service to Maltese citizens in order to prevent them arriving at the stage when they need to use the Cross-Border Directive. I always looked at EU legislation broadly, including the Cross-Border Directive, as a force that applies pressure on us to change (P18 politician).”

Moderate enhancement of patients’ rightsMost interviewees felt that the directive provided the impetus for patients’ rights legislation to be enacted and strongly doubted whether this legislation would have been implemented without the need to comply with the EU requirement.

“I don’t think this question of patients’ rights, for example, would have ever materialised had it not been because we needed to comply with EU legislation.” (P26 clinician)

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A civil society representative mentioned that Maltese patients are very passive when compared to their European counterparts. The externally-pushed obligation for legislation on patients’ rights to be adopted in a system that was not culturally ready seems to have led to a situation where although the legislative framework was adopted, most stakeholders were sceptical since patients still lack empowerment and very little has been done on issues of compensation and redress as strongly voiced by a senior health civil servant.

“We are failing on patients’ rights we are not sensitive enough to patients’ rights even though we may have them written on paper they are not at all respected in practice.” (P13 health civil servant)

Negligible additional patient mobilityFinally there was broad consensus around the fact that the directive to date has not had a real impact on patient mobility with free movement of patients still being ‘embryonic’ (P24 health civil servant). The lack of information and the gap between patients’ expectations and what is possible in practice were mentioned as two key barriers. A health civil servant remarked that patients may have been given the impression that they have a right to every treatment that exists in the European Union countries when in practice there are several restrictions on what is covered and reimbursed.

“I don’t think that people understand it very well yet. They think that they can go abroad, get their service and come back. In reality, there are restrictions, it is not so open” (P7 health civil servant)

Furthermore an EU affairs practitioner observed that the EU patient mobility framework could be reformed to make it more patient friendly. An academic raised the concern that patient mobility is for people who have money and described it as ‘somewhat of a dream’ (P1 academic).

The fact that patients only have a right to be reimbursed the local cost of the intervention is considered to be a major barrier by several stakeholders. This is well described by a politician.

“Maltese patients are at a very big disadvantage because they have to pay for their airfare and they only get refunded what the operation costs in Malta. This brings inequity between Maltese patients and patients in other European countries”. (P25 politician)



In conclusion some interviewees, mostly civil servants, believe that the impact will be minimal, particularly if issues such as waiting lists are addressed.

“Personally I do not think it will be a big impact if we take steps to sort out certain health system issues” (P13 health civil servant)

“I think that the Maltese people are very territorial and have a very high opinion of our healthcare services. So only very few would opt, in my opinion, to seek treatment abroad, in those cases where they can’t have it here in Malta (P24 health civil servant)

On the other hand other stakeholders believe that the directive will have a greater impact in future.

“I mean, it is a bit early but I think in the long run we will start seeing the impact in different areas of health provision (P21 EU affairs practitioner).

“I still believe that it is going to be a challenge but it will not be a challenge just for Malta, it will be a challenge for a lot of European countries. Pleasures yet to come…” (P3 politician)

DISCUSSION

This study has sought to analyse how the implementation of the cross-border directive has impacted upon the Maltese health care system. It has demonstrated how Europeanisation is occurring in health systems through a two-way relationship between EU level instruments and domestic actors embedded in their culture and context. Several key lessons emerge from this case study. Firstly, a high level of anticipated negative impact led to a restrictive approach which was taken to limit patient mobility. This in turn resulted in minimal utilisation of the rights bestowed by the directive with regards to cross-border care. The extensive use of prior authorisation and the decision to exclude private domestic providers from the local legislation are examples of such controls. Secondly, the directive was viewed as having potentially positive implications as a welcome external force for change on issues such as patients’ rights, standards of care, transparency and governance within the health system. Finally, in line with Legido-Quigley et. al.,(31) it was shown how contextual and cultural issues may greatly influence the legacy that specific directives have.

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Despite the fact that the Maltese reported the highest rate of willingness to seek cross-border healthcare services at 78% in 2015, this figure remained relatively stable since 2007 (82%),with the early impact of the patients’ rights and cross-border healthcare directive on the Maltese health system appearing to be limited in terms of patient mobility.(32-33) The relatively high degree of satisfaction with the local health care system (94%) and the existence of well-established alternative referral channels for care overseas, may have contributed to this minimal impact.(15,18,34) The lack of active information dissemination and the controlling manner in which the directive was implemented were also perceived as being of critical importance in preventing the much-feared patient exodus.

Whilst the implementation of systems and mechanisms to facilitate cross-border care as set out in the directive demonstrate the phenomenon of “downloading”,(10) where the Member State has to comply with the EU, this study has also illustrated how implementation of the directive could be having a broader effect on domestic health services policy in terms of compliance, opportunism and usage of Europe.(5,35-36) Policy makers appear to have acted as norm entrepreneurs in the case of the legislation on patients’ rights, clarification of entitlement and indemnity insurance with the directive giving them added strength to argue for implementation. The study provides an example of the ‘bounded rationality’ theory where policy makers may have not taken a holistic approach to the directive and chose to concentrate on instrumentalising the directive to bring about long-overdue structural reforms in the domestic health system whilst taking steps to mitigate against the anticipated negative financial and public health impact.(35,37) Similar developments could be observed in other small countries. In Latvia and Luxembourg for example, the directive also reportedly provided an opportunity to set up a legal framework for patients’ rights and appears to have provided the opportunity for obligatory professional indemnity insurance to be introduced for health care professionals other than doctors specifically in Luxembourg.(38-39)

The study has certain limitations. Whereas a careful selection took place to ensure a broad range of participants among decision-makers in health, patient representatives were not included. The results derived from the study are closely associated with the Maltese health care system’s unique features including the geo-demographic conditions and long tradition of organised cross-border referrals for highly specialised care. It is therefore acknowledged that the findings may not be easily transferable to other contexts.

Nonetheless, the dynamics discussed here are ones that could be reasonably expected to be visible in other countries. Hence, comparative analysis of stakeholder perspectives using a Europeanisation perspective from different Member States should be carried out to obtain a picture of the real impact of the directive on the various health systems. Such studies could be important to further elucidate prevailing gaps in service provision and



inequalities between the different regions in Europe which the current directive has so far failed to address. Observations obtained from the grassroots key actors within domestic health systems could lead to useful research that may inform future steps for a genuine European cross-border health policy. This would be grounded in public health needs assessment as opposed to political ideology and legal imperatives. Close monitoring of the unfolding impact of the directive across the EU is warranted.

CONCLUSION

This study has provided an insight into the implementation of the patients’ rights and cross border directive and its early outcomes, as observed through the lens of a small EU Member State with a long-standing tradition of organised cross-border health collaboration. It has illustrated how Europeanisation of health systems through this seminal legislation on health services has occurred through both passive downloading and active utilisation of the EU rules. The indication is that the impact of the Directive in terms of additional patient mobility will be minimal and the Directive is more important in terms of the domestic health system changes it has triggered.

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REFERENCES

1. European Union, Directive (2011/24/EU) of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare. OJ L 88:2011, April 4, 45.

2. Peeters M. Free movement of patients: Directive 2011/24 on the application of patients’ rights in cross-border healthcare. Eur J Health Law 2012 March; 19(1):29-60.

3. Delnoij D, Sauter W. Patient information under the EU patients’ rights directive. Eur J Public Health 2011 June; (3):271-272.

4. Greer SL, Hervey TK, Mackenbach JP, McKee M. Health law and policy in the European Union. Lancet 2013; 381(9872):1135-1144.

5. Greer SL. The three faces of European Union health policy: Policy, markets, and austerity, Policy and Society 2014; 33(1):13-24.

6. Baeten R. Cross-border patient mobility in the European Union: in search of benefits from the new legal framework. J Health Serv Res Policy 2014; 19(4):195-197.

7. Nys H. The transposition of the Directive on Patients’ Rights in Cross-care Healthcare in national law by the Member States: still a lot of effort to be made and questions to be answered. Eur J Health Law 2014 March; 21(1):1-14.

8. Kostera T. Europeanizing Healthcare: Cross-border Patient Mobility and Its Consequences for the German and Danish Healthcare Systems. Bruges Political Research Paper No. 7, Bruges Political Research Paper series 38; May 2008.

9. Baeten R, Vanhercke B, Coucheir M. The Europeanisation of national health care systems: creative adaptation in the shadow of patient mobility case law. OSE Paper Series; 2010.

10. Baeten R. Europeanization of national health systems, National impact and EU codification of the patient mobility case law. OSE Paper Series; 2012.

11. Commission of the European Communities. Commission Staff Working Document Accompanying document to the Proposal for a Directive of the European Parliament and of the Council on the Application of Patients’ Rights in Cross-border Healthcare Impact Assessment {COM(2008) 414 final} {SEC(2008) 2164}. 2008 02.07.2008;SEC(2008) 2163.

12. Azzopardi Muscat N, Grech K, Cachia JM, Xuereb D. Sharing capacities–Malta and the United Kingdom, In: Rosenmoller M, McKee M, Baeten R, editors. Patient Mobility in the European Union Learning from Experience Copenhagen: World Health Organization; 2006. on behalf of the Europe 4 Patients project and the European Observatory on Health Systems and Policies, 2006, 119.

13. Saliba V, Muscat NA, Vella M, Montalto SA, Fenech C, McKee M et al., Clinicians’, policy makers’ and patients’ views of pediatric cross-border care between Malta and the UK. J Health Serv Res Policy 2014 Jul 1; 19:(3):153-160.

14. Malta Independent, Health - Historic Agreement signed between Malta and Italy. TMI; 2012, September 6.

15. Government of Malta, Ministry for Health Annual Report 2013, 2014. 16. Martinsen DS. The Europeanization of Health Care: Processes and Factors. In: Exadaktylos

T, Radaelli CM, editors. Research design in European studies: Establishing causality in Europeanization, 2012, p.141.

17. Radaelli CM. The Europeanisation of Public Policy, In: Featherstone K, Radaelli CM, editors. The politics of Europeanization. Oxford University Press; 2003. pp. 27-56.

18. Creswell JW. Qualitative inquiry and research design: choosing among five approaches, Sage publications; 2012.



19. Versluis E, Van Keulen M, Stephenson P. Analyzing the European Union policy process. Palgrave Macmillan; 2010.

20. Exadaktylos T, Radaelli CM. Research design in European studies: establishing causality in Europeanization. Palgrave Macmillan; 2012.

21. Azzopardi Muscat N, Calleja N, Calleja A, Cylus J. Health systems in transition Malta. Health 16 (1), 2014.

22. Flick U. Chapter 22 Using documents as data. An introduction to qualitative research. 5th ed., Sage; 2014. pp. 352-362.

23. House of Representatives M. Health Act - XI of 2013, 2013.24. Government of Malta, Cross-Border Healthcare Regulations, 2013 L.N. 389 of 2013 HEALTH

ACT, 2013 (ACT XI of 2013). 2013.25. Government of Malta, Subsidiary Legislation 528.02 Indemnity Insurance for Healthcare

Professionals Regulations Legal Notice 84 of 2014, 2014.26. Camilleri JD, Filletti JA, Depasquale A. Cachia Katerina Vs Direttur Generali Tad-

Dipartiment Tas-Sahha Et. 2007.27. Camilleri S, Magri AJ, Mallia T. Cassar Daniel James Vs Direttur Tas-Sahha Istituzzjonali Et,

2011.28. Government of Malta, A better quality of life 2006-2010 Pre Budget Document, 2005,

Available at: http://mfin.gov.mt/en/The-Budget/Documents/The%20Budget%202006/2006-2010%20Pre-Budget%20Document%20(English).pdf. [accessed 13.10.14].

29. Strategy and Sustainability Division Ministry for Social Policy Malta. National Report on Strategies for Social Protection and Social Inclusion 2008-2010, 2009, February.

30. Malta Independent. Public Consultation Meeting on Health Act. TMI 2013, September 21.31. Times of Malta.com, People face higher fees for doctors’ insurance, 2013, Available at:

http://www.timesofmalta.com/articles/view/20131118/local/People-face-higher-fees-for-doctors-insurance.495186 [accessed 13.10.14].

32. The Malta Independent online, Pharmacists obliged to insure against negligence claims, 2013, Available at: http://www.independent.com.mt/articles/2013-12-14/news/pharmacists-obliged-to-insure-against-negligence-claims-3458170881/ [accessed 13.10.14].

33. Flash Eurobarometer 210 Cross-border health services in the EU, 2007, June, 210.34. Prudil L. Implementation of the Directive 2011/24/EU in the Czech Republic, Eur J Health

Law 2014 March 21(1):15-22.35. European Commission, Special Eurobarometer 411 Patient safety and quality of care, 2015,

Available at: http://ec.europa.eu/public_opinion/archives/ebs/ebs_411_en.pdf [accessed 22.03.15].

36. National Audit Office M, Performance Audit ‘The Management of Elective Surgery Waiting Lists’, Report by the Auditor General, 2013, June.

37. Vollaard H, Martinsen DS. Bounded Rationality in Transposition Processes: The Case of the European Patients’ Rights Directive, West Eur Polit 2014; 37 (4):711-731.

38. Olsena S. Implementation of the Patients’ Rights in Cross-border Healthcare directive in Latvia, Eur J Health Law 2014 March; 21(1): 46-55.

39. Schwebag M. Implementation of the Cross-border Care Directive in EU Member States: Luxembourg, Eur J Health Law 2014 March; 21(1):56-64.

CHAPTER 6The EU Joint Procurement Agreement

for Cross Border Health Threats:

What is the Potential for this new

Mechanism of Health System Collaboration?

Azzopardi-Muscat N., Schroder-Back P., Brand H. The EU Joint Procurement Agreement for Cross Border Health Threats:

What is the potential for this new mechanism of Health System collaboration? Accepted manuscript for publication Health Economics Policy &Law

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ABSTRACT

The Joint Procurement Agreement (JPA) is an innovative instrument for multi-country procurement of medical counter measures against cross border health threats. This paper aims to assess its potential performance. A literature review was conducted to identify key features of successful joint procurement programmes. Documentary analysis and a key informants’ interview were carried out to analyse the European Union (EU) JPA. Ownership, equity, transparency, stable central financing, standardisation, flexibility and gradual development were identified as important prerequisites for successful establishment of multi-country joint procurement programmes in the literature while security of supply, favourable prices, reduction of operational costs and administrative burden and creation of professional expert networks were identified as desirable outcomes. The EU JPA appears to fulfil the criteria of ownership, transparency, equity, flexibility and gradual development. Standardisation is only partly fulfilled and central EU level financing is not provided. Security of supply is an important outcome for all EU Member States (MS). Price savings, reduction in administrative burden and creation of professional networks may be particularly attractive for the smaller MS. The JPA has the potential to increase health system collaboration and efficiency at EU level provided that the incentives for sustained commitment of larger MS are sufficiently attractive.

KeywordsPooled procurement, Joint procurement, Medicines, Vaccines, Cross border health threats, European Union, Health system


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INTRODUCTION

The European Union (EU) has a mandate to protect the health of European Union citizens. This was initially defined in the Maastricht Treaty in 1992. A recent evaluation of key stakeholders’ perceptions regarding the way in which the public health mandate was implemented concluded that the EU has become an important player in the public health arena and has “begun to develop competencies in supporting, coordinating and supplementing Member State health actions”.(1-2) The adoption of the directive on patients’ rights and cross border care in 2011 is traditionally considered important for clarifying the rights of patients to reimbursement of cross-border care following a spate of judgements by the European Court of Justice.(3) However an often overlooked aspect of this directive is the establishment of a legal basis for cooperation between health systems in areas such as rare diseases, health technology assessment and e-health.(4-5) This is a rapidly developing area of health policy development at EU level through which Member States may benefit from seeking to cooperate in specific areas of EU added value as they are urged to respond to common challenges facing health systems throughout the EU.(6)

The implementation of the Joint Procurement Agreement (JPA) to procure medical countermeasures by the European Commission and EU Member States is an innovative instrument aimed at encouraging Member States to increase forms of health system cooperation on a voluntary basis to ensure better public health protection at European level.(7) This Agreement therefore also presents an example of the approach to developing health policy at EU level through health system cooperation. The development of the Joint Procurement Agreement was stimulated by experience of the 2010 H1N1 influenza pandemic in which Member States competed to obtain scarce supplies of medicines, being obliged to pay high prices for medicines that, in the end, were hardly needed. The publication of a Commission report on EU-wide pandemic vaccine strategies identified a number of weaknesses in the procurement of pandemic influenza vaccines and antivirals by Member States at that time.(8) Council Conclusions adopted under the Belgian Presidency in September 2010 invited the Commission to develop a mechanism for common acquisition or development of common approaches to contract negotiations with manufacturers of vaccines and antiviral medication.(9) Such a mechanism, in which Member States could opt to participate on a voluntary basis, was to address issues such as liability, availability and price of medicinal products and confidentiality.(10) The topic of multi-country joint procurement for health commodities is not new but has rather been a focus of interest for middle and low income countries including Caribbean islands, Sub-Saharan African countries and Gulf States. Group procurement is viewed as a potential means of increasing competition among suppliers and thus reducing prices

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which has as an effect increasing equity by offering all member countries the same prices, regardless of their market size or level of development.(11) Whilst larger countries would normally search for solutions that set up groups at regional or national level, for small countries these advantages can usually only be obtained through international cooperation.(12) Whilst it is acknowledged that EU Member States are at a different level of economic development to many of these countries, an understanding of experiences of engaging in multi-country procurement initiatives from other parts of the world can be informative, offering an opportunity to explore innovative solutions to challenging circumstances. This is especially important given that the potential for circumstances to arise in the future sharing some features of the H1N1 pandemic, a situation in which “politics as usual” may not apply and so that there is a need to look beyond conventional policy solutions. Thus, the financial and economic crisis has led to particular problems with access to medicines in certain EU Member States notably in Greece, although drug shortages are experienced routinely in several EU Member States.(13-14) Furthermore, shortages of vaccines have also been experienced by EU countries struggling to deal with the unexpected influx of refugees.(15) Finally the European pharmaceutical industry itself also appears to be interested in exploring new forms of managing entry of products on the European market.(16) Therefore, the rapidly changing context within which EU Member State health systems find themselves may necessitate the exploration of previously untapped policy solutions.

The EU’s Joint Procurement Agreement provides a vehicle for multi-country joint procurement of medicines. The European Commission and the 22 Member States that have signed the Agreement (Table 1), expect that this “… will strengthen the Contracting Parties’ purchasing power and ensure equitable access to medical countermeasures against serious cross border threats to health”.(17) Accordingly, vaccines to counter infectious diseases are of particular interest in this perspective since they are important for striving towards herd immunity at European level. Smaller MS may perceive certain advantages of participation in joint procurement such as obtaining vaccines or medicines at a lower price. Indeed all EU Member States with populations under five million signed the Joint Procurement Agreement as of November 2015 (Table 1). Of the Member States who have not yet signed, Austria, Bulgaria, Finland, Germany and Sweden are all progressing towards internal approval of the Joint Procurement Agreement within their national political structures. Poland is the only country which had explicitly not agreed with the formulation of the Agreement on a point of principle although other research has drawn attention to problems with pharmaceutical procurement in Poland that may also be a salient factor.(18-19) Larger countries may even perceive such a mechanism as a disadvantage by forfeiting their sovereign rights to negotiate directly with suppliers, including the benefits they obtain by avoiding pricing transparency. We deem the EU



JPA an important object for policy analysis since it marks a new approach to cooperation between health systems that can is of particular policy relevance at times of financial austerity.

Table 6.1 - List of countries having signed the Joint Procurement Agreement(Updated 08/11/2015)Member State Date of Signature of Joint Procurement AgreementBelgiumCroatiaCzech RepublicCyprusEstoniaGreeceLatviaMaltaNetherlandsPortugalSlovakiaSloveniaSpainUnited Kingdom

20 June 2014

Luxembourg 26 June 2014Romania 23 September 2014Italy 16 October 2014Hungary 12 November 2014DenmarkLithuania

1 December 2014

Ireland 19 June 2015France 22 September 2015

Framing the issueAn examination of the events, context and circumstances that led to the adoption of the Agreement is necessary given the traditional reluctance for health matters to be a matter for European level action coupled with the current wave of Euroscepticism.(20) An analysis of the Agreement content as well as the ideology, issues, influence, initiative, interests and institutional context that determined this content is all important to understand the extent to which the mechanism is a natural progression of the developments in health policy at EU level.(21) This in turn may reflect the depth and breadth of commitment to the initiative and hence the likelihood of successful implementation and durability. The Agreement can be analysed with reference to the literature on multi-country pooled procurement mechanisms since this can provide a framework for an ex-ante assessment of the potential in this new mechanism for health systems collaboration at EU level.

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This could be important to further our understanding of the way in which aspects of public health policy and practice are being ‘Europeanised’,2 and to what extent this Europeanisation is driven by or at least in line with values such as equity and solidarity versus exigencies of the market.(22) This latter consideration is relevant given the criticism that market ideology and economic considerations are dominating developments in EU health policy.(23-24) In the light of the foregoing considerations, this paper analyses the Agreement’s potential by seeking to answer the following research questions: What are the important prerequisites and successful outcomes associated with multi-country joint procurement programmes? How has the Agreement been developed and what are its main features? How is the Agreement expected to perform as an innovative mechanism for EU health system collaboration?

METHODS

In order to answer these research questions a qualitative approach was adopted as this is deemed to be a suitable approach for the analysis of a policy process.(25-26) A range of methods and data sources were used, with triangulation of data to strengthen the validity of the study. A literature review was conducted using PubMed. Publications were not truncated for year of publication and were limited to the English language. The key terms used were a combination of multi-country, pooled or joint procurement, vaccine, pharmaceutical, medicine, medical device and commodity. Searches based on these terms were also run in Web of Science, EBSCO and Google Scholar. The available literature was reviewed to identify benefits, critical success factors and barriers to effective and sustainable multi-country procurement programmes for health commodities. The literature available to inform this paper is limited since the topic is very new at a European level and most of the available literature comes from a low and middle income country context which, although informative, as noted above, is not always directly relevant. The scope of this policy analysis was therefore extended by including a documentary analysis of key material relating to the Agreement while a key informants’ interview was used for confirmatory validation. A detailed analysis of the JPA documentation was carried out. The source was official documents retrieved from the European Commission’s website and included media communications, proceedings of meetings, informational and decisional documents. According to Flick, documentary analysis can be a fruitful addition to other forms of data, provided that the context of their production is also taken into account.(27) An analysis of the prevailing context within which the JPA was developed was therefore also conducted. A single in-depth telephone interview with two European Commission officials from the Health Threats 2 (Europeanisation is taken to mean the impact of European level policy on domestic policies, actors and institutions)



Unit responsible for the implementation of the Agreement was carried out in December 2014. The interview proceeded according to a structured interview guide that was drawn up after the literature review and documentary analysis were conducted. The purpose of this interview was primarily to obtain confirmatory validation of the findings obtained through the documentary analysis and literature review. Notes taken during the interview were immediately recorded as an interview report. The report was sent back to the interviewees for them to check the factual accuracy. Their permission was sought and obtained to refer to the content of the interview in the context of the preparation and presentation of this research paper.

RESULTS

There is limited literature available evaluating multi-country joint procurement in the health care sector and the literature search only yielded seven relevant papers. Most information about evaluation of multi-country joint procurement comes from an analysis of the following middle-low income country multi-country procurement programmes: Organisation of Eastern Caribbean States (OECS) Pharmaceutical Procurement Service (PPS) report,(12) Proposal for a multi-country group procurement scheme in Eastern Europe,(28) PAHO revolving fund for vaccine procurement, Gulf Cooperation Council (GCC) group purchasing programme,(29) Global Fund Programme (TB, HIV, Malaria),(30-32) and the United Nations Fund for Procurement Activities (UNFPA).(11)

Eleven factors associated with multi-country procurement programmes were extracted from the literature review and classified thematically. Seven factors have been categorised as prerequisites for programmes to become established successfully and four factors have been classified as desired outcomes that need to be achieved to sustain such programmes successfully. We interpret the link among these factors in such a way that the strong presence of prerequisites leads to desired outcomes and the generation of desired outcomes in itself further contributes to sustainable programmes.

Prerequisites for successful multi-country joint procurement programmesStrong central leadership and management and a high level of political will from participating countries seems necessary to develop a joint procurement initiative. However it is equally important for all the partner members to be part of the decision making mechanism and to have a high level of involvement.(11) Equitable representation of partners in decision making and equitable criteria for the allocation of scarce supplies have been identified as key factors for building trust in the joint procurement programme.(11) The use of an independent agency and a transparent, competitive tender and bid process has been described as a key incentive for countries to join an international group

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procurement programme in the literature from developing countries since this prevents fraud and corruption and overcomes the problem of hidden costs for suppliers.(11, 29) Stability in the availability of funds, mechanisms to decrease financing risk and prompt payment were associated with successful joint procurement programmes. An element of regional or supra national central financing was also considered necessary to ensure sustainable funding of the central operations for the joint procurement mechanism.(12,29) Uniform procurement regulations and standard requirements and specifications are viewed as a prerequisite for joint procurement endeavours. A uniform formulary at regional level is also an asset.(12,28) Flexibility with regards to the participation in the mechanism has been shown to be an important factor that enables particularly some of the larger countries to stay in the joint procurement scheme. The GCC allows participating countries to vary the quantity of the initial order by 20% as well as providing some possibilities to cater for specific country needs. On the other hand the lack of an exclusivity clause may encourage some of the larger countries in particular to pursue individual and joint procurement in parallel. Whilst retaining these countries in the mechanism is important to maintain the volume of orders, this may also create conflicts of interest.(12) The literature indicates that schemes such as those operated by the Caribbean and Gulf countries, which started with a small group of highly committed countries and a small portfolio of goods, went on to develop further in a step wise fashion building on positive experiences.(11) Since countries and other observers will at least partly judge success of the pilot scheme on the price reductions and overall cost savings achieved, it may be preferable to include at least one larger country in the pilot phase in order to achieve more substantial price reductions.(28)

Successful outcomesThe GCC group procurement mechanism achieved security of supply by a combination of shortening the procurement process, increasing the predictability of timing and simplifying procedures. This also led to improvements in supply chain management.(29) Furthermore sharing of information about suppliers and use of pre-screening reduced the risk of engaging with suppliers with poor track records.(12) Reductions in unit purchase price seem to have garnered increased support for the mechanism.(11) Yet, the evidence on price savings is mixed – some report considerable cost savings to the individual countries including those with small populations.(12,29) Others did not confer financial advantages for all commonly purchased devices.(30,32) The savings made on operational costs and reduced administrative burden is a major factor encouraging participation in the scheme. If the joint procurement mechanism becomes expensive to administer then these savings are neutralised, potentially leading countries to opt out of the scheme.(29) Clearly defined procurement mechanisms, simple procurement design which minimises



contractual risk and a low level of administrative burden have been noted as key success factors.(11-12) One of the main benefits derived from multi-country pooled procurement has been the creation of networks of professional experts.(33) Informal peer relationships linking experts have been shown to influence positively the sustainability of pooled procurement agreements.(11)

Analysis of the development of the JPAThe Agreement was adopted in April 2014 and came into force in June 2014 when the first fourteen Member States signed. As of November 2015, 22 out of 28 Member States had signed the Agreement (Table 6.1).(34) The stated objectives for the mechanism are to ensure that pandemic vaccines and other medical countermeasures would be available in sufficient quantities with access being guaranteed for all participating Member States.(10) During the 2010 Influenza A H1N1 pandemic a number of Member States experienced difficulties with access to pandemic vaccine and anti-virals.(35) The key problems related to price, liability, confidentiality, and flexibility to adjust quantities ordered to actual needs in the procurement of vaccines and antivirals. These problems are seen as the main triggers for the Council and the European Parliament to request that the European Commission creates a mechanism for joint procurement of vaccines in view of the risk of a potential future pandemic.(10) Whilst in its final report published in 2008, the High Level Pharmaceutical Forum had drawn attention to the problems with access to certain medicines being faced by small national markets, during the 2010 influenza pandemic difficulties in access were experienced on a wider scale.(36) The proposal initially was not enthusiastically welcomed by all Member States, since those which already had agreements in place with the industry for pandemic vaccine supply were disinterested in pursuing such a venture.(37) The vaccine and pharmaceutical industry was initially also concerned about this development since it viewed the initiative as a potential vehicle to create a monopsony in Europe which would drive down prices.(37) The strong normative public health basis for action appears therefore to have been the main driver that led to a quasi-unanimous agreement to the principle of pursuing a mechanism for joint procurement for cross border threats.(28) Following the rapid agreement in principle, subsequent negotiations on the Agreement were relatively protracted although delays in the decision making process are reported to have been due more to the technicalities of legal and administrative ratification of this innovative mechanism by the various Member States rather than to issues of principle.(37)

On the basis of Article 168(5) TFEU, Decision 1082/2013/EU on cross border health threats was adopted.(38) Article 5 of that Decision regards joint procurement of medical countermeasures. Article 5(1) provides that “The institutions of the Union and any Member States which so desire may engage in a joint procurement procedure (…) with

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a view to the advance purchase of medical countermeasures for serious cross-border threats to health.” The adoption of the Decision on cross border health threats therefore provided the necessary legal basis for the Agreement to be negotiated. The scope was widened from the procurement of vaccines to include medical countermeasures. The focus however remained strictly that of serious cross-border threats to health. Analysis of the text of the Agreement showed that it determines the practical arrangements governing the procurement procedures, defines the decision-making process with regard to the choice of the procedure and organizes the assessment of the tenders and the award of the contract.(17) The text clearly underlines the voluntary nature of participation in this initiative and the freedom of MS to decide whether or not to participate in the Agreement itself or in any single procurement procedure launched through the Agreement. The decision to participate in a particular joint procurement procedure does not prevent a Member State from carrying out simultaneous independent procurement procedures at national level, even when they involve the same medical countermeasures or the same operators. A Member State may withdraw from Agreement at any time. The Agreement outlines the envisaged mechanisms of allocation. Participating Member States should receive the total quantity of the ordered or reserved measures, but the rate of delivery will depend on the production capacity of the manufacturers and the approved allocation criteria. The Agreement furthermore foresees a possibility of derogation from the generally applicable allocation criteria in problematic situations, such as delivery problems or urgent needs (e.g. in case of a pandemic striking more strongly in one or more Member State). This may mean that particular Member States would obtain more or less than the volume specified through the allocation criteria. The manner in which derogation from the set allocation criteria will apply is not yet entirely clear but will require sufficient flexibility. The administrative arrangements underpinning the Agreement are set out in detail in the policy instrument. The Commission plays a key role since it acts as the Permanent Secretariat and is responsible for ensuring the overall preparation and organisation of the joint procurement procedure. It has been granted a powerful role through providing the Secretariat and Chair of each Steering Committee. For each specific procurement procedure, a separate committee is established with responsibility for matters relating to the specific joint procurement procedure. For each specific procedure, the committee must determine the technical specifications and criteria for allocation of medical countermeasures, including temporary deviations from the allocation criteria in case of greater need. Decision making is by qualified majority, taking account of the financial commitment made by each Contracting Party. Overall the formulation of the Agreement allows a certain degree of flexibility for Member States but details the processes and procedures to be followed.



DISCUSSION

Having presented the key factors associated with sustainable multi-country joint procurement initiatives, we now examine the potential of the Agreement as an innovative mechanism for health system collaboration between EU Member States. The first part of the discussion assesses the Agreement’s likelihood of success in relation to the identified prerequisites for successful multi-country joint procurement programmes. In the second part we discuss the extent to which successful outcomes from multi-country joint procurement programmes reported in the literature from developing countries are relevant to the current EU context. We also consider whether the Agreement could serve as an impetus for further health policy development and health systems collaboration at EU level.

Although the Agreement is possibly more beneficial to small MS, 22 Member States including a few larger Member States had signed up by November 2015 indicating a high level of commitment to its principles. However, representation within the decision-making structure of the Agreement is not equal for all Member States and neither is it the traditional qualified majority voting used in the EU Council of Ministers. Instead it is proportionate to the level of investment in the scheme (as requested by the “equity” factor). Whilst this will still favour larger Member States, it also attempts to take into account the level of commitment such that smaller countries with a higher financial commitment than larger countries would have more votes in the mechanism. The Agreement will follow the EU procurement processes and the decision making structure provides for a high level of transparency in procedures. The possibility of launching a procedure even if there are only four countries and the European Commission is a positive feature since the literature indicates that such initiatives grow and develop gradually over time. This feature also provides room for small Member States to collaborate even if the matter at hand is not of interest to the larger Member States.

The lack of specific EU level funding for the Agreement could be deemed as a factor hindering the programme’s sustainability, as adequate and stable financing does not seem to be guaranteed for the coordination of the initiative. A small amount of European funding to cover the administrative and operational costs would provide continuity and contribute to the sustainability of this mechanism. When it comes to standardisation, whilst procurement policies are harmonised at EU level, the lack of uniform formularies could well be a weakness impeding joint procurement. However, if the European Commission is perceived by Member States to be using the Agreement as some sort of ‘Trojan horse’ to attempt to bring about harmonisation of the formularies, this could trigger a backlash from Member States intent on safeguarding the well-established national competence to determine formulary lists.(39) Member States may then react by not committing

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to participate in any procurement procedures thereby placing in question the future operation of the Agreement. It is possible that some degree of formulary harmonisation will emerge as a by-product, triggered by voluntary adoption of common standards by Member States seeking to build deeper cooperation in medicines procurement through the JPA as has happened in between the Gulf States.(11)

The concept of flexibility and exclusivity is a double edged sword for the enduring viability of the Agreement. It would not have seen the light of day without sufficient flexibility, which does not demand exclusivity from Member States, since most Member States accepted the agreement because of these characteristics. However, these could also be the weakest part of the Agreement since Member States may not commit themselves fully to the ideal of equity and solidarity fostered through participation in the Agreement. Although 22 Member States have signed up, it is important to recall that Member States can opt out at any stage.

Security of supply in the event of a pandemic was the key factor that drove Member States to work towards setting up a joint procurement mechanism. Health security has recently been considered as one of the soft security aspects for which the EU may provide shelter for small Member States.(40) The Agreement is viewed as a good example of this. Whilst favourable prices are often perceived to be the main motivation for pooled procurement, price reductions may not always materialise and national engagement will often be based on factors other than price. The lowering of price will be resisted by industry and it may be possible to imagine a scenario where individual larger Member States obtain better prices through bilateral negotiation. In such a scenario, steps would need to be taken to avoid the domino effect of countries dropping out. Dropping out is also likely to arise if the Agreement becomes overly bureaucratic so this must be avoided, as inefficiency and lack of timeliness in procurement would work against the potential reduction of operational costs. On the other hand the Agreement could potentially enhance health system performance, a key target for the new Commission by reducing the need for multiple procurement processes across the European Union health systems.(41) Pooled procurement functions may therefore be viewed as a pragmatic support service provided by regional supranational organisations for their MS. In this sense the Agreement may emerge as a mechanism that enhances efficiency and resilience echoing the principles for EU health systems outlined in the Commission Communication of 2014.(6) This is particularly likely to be the case for small health systems where such procurement processes may be expensive overheads.

Procurement has not typically been viewed as a complex activity requiring networking. However the procurement of counter measures for cross border threats is different from that for staple supplies. Thus, networking between health technology procurement experts for exchange of information and best practices could well be one of



the most unintended, yet important, outcomes from the Agreement particularly for the smaller MS where professional isolation often emerges as a significant issue. The creation of professional expert networks has been shown to be a driver for the development of European health policy in communicable disease control where technical rational argumentation served to drive political action.(42) The forerunners of the European Centre for Disease Control were actually networks of experts coordinating information, research and developing guidelines at European level. Such networking could be modelled on the existing professional networks for Health Technology Assessment, an area of activity which is now legally established in EU Directive 2011/24 and which offers plenty of scope for interaction with joint procurement activities at EU level.

Having discussed the Agreement in light of the critical success factors that help in creating and sustaining a programme, we turn now to other factors that appeared relevant in our analysis and are expected to play a role in developing the potential of the Agreement. Smaller Member States, poorer Member States and the Commission appear to have come together to provide the necessary impetus for a joint procurement initiative to be created. The issue of national pride and self- determination may preclude countries from deciding to participate in the Agreement. Yet smaller countries in search of pragmatic solutions are less likely to seek to develop their own capacity, expertise and resources for highly specialised procurement and are more likely to take up the possibilities offered through the Agreement. However the participation of medium sized or large countries is also important, not only because of the potential to achieve greater cost savings and lower unit prices but also because of the expertise that resides within larger countries. (28,43) It should, however, be noted that convening small countries could also be viewed as a measure of success when evaluating the impact of the Agreement. This could herald a new possibility for small Member States to engage in forms of cooperation not usually seen at EU level where interests of Member States often differ.(44) The Agreement, by enhancing health system collaboration, may become a source of further Europeanisation of health policy. A neo-functionalist approach can explain the further development and implementation of the Agreement at EU level whereby “the national state which no longer feels capable of realising welfare aims within its narrow borders, has made its peace with the fact of interdependence …. (Haas 1964)”.(45)

Whilst the scope for joint procurement may seem limited by its current legal basis, which requires that the scope of procurement be limited to cross-border health threats, interest in exploring joint procurement for rare communicable diseases such as Anthrax, Botulism, Rabies as well as for innovative treatment for relatively common conditions such as HIV/TB/Hepatitis C has been shown.(37) The Agreement can bring about the adoption of innovative procurement approaches at EU level which in turn may serve as a stimulus to research on novel antibiotics needed to tackle anti-microbial resistance by

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guaranteeing industry an adequate scale of purchases.(46) The possibility of using joint procurement for procurement of orphan drugs for rare diseases has also been raised.(47) The Netherlands and Belgium announced joint negotiations with pharmaceutical groups focusing on diseases which affect fewer than five in 100,000 people, for which treatments are often very expensive due to the limited market.(48)

This initiative, if successful, would pave the way for further joint procurement at EU level although a different legal basis would be necessary to take this forward. Establishing the practical feasibility through a first procurement initiative seems to be urgently necessary. The Agreement was mentioned as a potential avenue for procurement of counter measures against Ebola.(49) Unfortunately the slow response does not augur well for the mechanism to be used in rapidly escalating situation. However it could well be that once a practical small scale first initiative is implemented and lessons learned it could be foreseen that different groups of Member States may put in requests for joint procurement of different treatments depending on their epidemiological burden, economic situation and negotiation leverage with the multi-national industry.

CONCLUSION

In conclusion, the EU Joint Procurement Agreement justifies policy analysis as an innovative form of European public health action. Our assessment indicates that the Agreement appears to fulfil the prerequisites of ownership, transparency and gradual development. It also strongly achieves the prerequisite of flexibility but this may actually turn out to be one of its major weaknesses in securing ongoing commitment. Standardisation has been achieved in procurement regulations but not formulary development. Equity is partly achieved through the decision making structures but does not appear to be the underlying theme motivating the development of this policy instrument. The element of central funding is not achieved. Of the desired outcomes described in the literature, security of supply appears to have been the main outcome that drove the development of the Joint Procurement Agreement. Price savings, reduction in operational costs and administrative burden and development of professional networks appear to be outcomes that may be more attractive to the smaller Member States. Furthermore, we found that a “window of opportunity” characterised by the influenza pandemic of 2010 was important in creating the impetus for the Agreement to be established.

At this stage the Agreement demonstrates potential as an innovative mechanism for health system collaboration at EU level, particularly for the smaller Member States and has been designed in a manner that achieves most of the attributes associated with successful multi-country procurement programmes. However the incentives for sustained



commitment of larger MS to this initiative in practice may not be sufficiently attractive. Further research is needed during and following the practical implementation of joint procurement procedures launched within the framework to capture the perspective of multiple stakeholder regarding the European added value of this initiative.

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of the Problems Underlying Drug Shortages, as Viewed from Belgian, French and the European Union’s Perspectives. 2015.

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17. European Commission ANNEX to the COMMISSION DECISION of 10 April 2014 C(2014) 2258 final on approval of the Joint Procurement Agreement to procure medical countermeasures pursuant to Decision 1082/2013/EU.

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21. Walt G, Shiffman J, Schneider H, Murray SF, Brugha R, Gilson L. ‘Doing’ health policy analysis: methodological and conceptual reflections and challenges. Health Policy Plan 2008 Sep;23(5):308-317.

22. Radaelli CM, Pasquier R. Conceptual Issues. In: Graziano P, Vink MP, editors. Europeanization: new research Agendas: Palgrave Macmillan; 2007. p. 35-45.

23. Greer SL. The three faces of European Union health policy: Policy, markets, and austerity. Policy and Society 2014;33(1):13-24.

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2000. p. 57.46. World Health Organisation Regional Office for Europe. Access to new medicines in Europe:

technical review of policy initiatives and opportunities for collaboration and research. 2015 March 2015.

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CHAPTER 7EU Country Specific Recommendations for Health

Systems in the European Semester process:

Trends, Discourse and Predictors

Azzopardi-Muscat N., Clemens T. Stoner D., Brand H. EU Country Specific Recommendations in the European Semester: Trends, Discourse and

Predictors Published in Health Policy 119(3) 375-383 March 2015 http://dx.doi.org/10.1016/j.healthpol.2015.01.007

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ABSTRACT

In the framework of “Europe 2020”, European Union Member States are subject to a new system of economic monitoring and governance known as the European Semester. This paper seeks to analyse the way in which national health systems are being influenced by EU institutions through the European Semester. A content analysis of the Country Specific Recommendations (CSRs) for the years 2011, 2012, 2013 and 2014 was carried out. This confirmed an increasing trend for health systems to feature in CSRs which tend to be framed in the discourse on sustainability of public finances rather than that of social inclusion with a predominant focus on the policy objective of sustainability. The likelihood of obtaining a health CSRs was tested against a series of financial health system performance indicators and general government finance indicators. The odds ratio of obtaining a health CSR increased slightly with the increase in level of general Government debt, with an OR= 1.02 (CI: 1.01, 1.03 p=0.007) and decreased with an increased public health expenditure/total health expenditure ratio, with an OR 0.89 (CI: 0.84, 0.96 p=0.001). The European Semester process is a relatively new process that is influencing health systems in the European Union. The effect of this process on health systems merits further attention. Health stakeholders should seek to engage more closely with this process which if steered appropriately could also present opportunities for health system reform.

Key wordsMeSH headings: Health Policy, Health Care Reform, Health Expenditures, European Union

Other terms:European Semester, Country Specific Recommendations, Health Systems


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INTRODUCTION

The role of the European Union in relation to health systems and policies has been described in terms of three ‘faces’.(1) First Article 168 of the Treaty gives a basis for the EU to promote public health policies which is the longest established strand of health policy activity and can be traced back to the initial vertical programmes on AIDs and cancer as well as activity in the realm of health information.(2-6) The second face refers to the role of the internal market in European health care policy. Initially mainly driven by the European Courts of Justice,(7-8) national concerns about the effect of these rulings resulted in the High Level Reflection process on patient mobility.(9-11) Member States rejected the inclusion of health in the Services (Bolkenstein) Directive but the adoption of the Directive on the application of patients’ rights in cross border care in 2011 marked a new era in European Union competence for health systems.(12) Whilst the concept of health systems monitoring and assessment was introduced in 2004 as part of the open method of coordination,(13) Directive 2011/24 promotes coordination between Member States from a broader health system perspective.(14) The subject of this paper deals with the third face of EU policy that is impacting on health systems which is the new system of fiscal and economic governance.(15) The European Commission has advocated a stronger degree of ex ante policy coordination in important economic sectors.(16) The Economic Adjustment Programmes adopted in Ireland, Greece, Portugal and Cyprus have resulted in prescriptive guidance influencing policy developments in Member States’ health systems.(17,18-21).

In the framework of the “Europe 2020” strategy all Member States are subject to a new system of economic monitoring and governance known as the European Semester.(22-23) This process of preventive and corrective action has emerged in the wake of the financial crisis as an attempt to reform and strengthen the Stability and Growth Pact. It enables the Commission and Council to carry out surveillance of economic indicators as well as big budgetary programmes. In November of each year the Commission sets out its priorities in the Annual Growth Survey.(18-21) On the basis of these priorities the EU Heads of State issue policy guidance to Member States in March. This policy guidance is then meant to be reflected in the drawing up of National Reform Programmes and Stability /Convergence Programmes by each Member State. These programmes are assessed by the Commission which then draws up a number of Country Specific Recommendations (CSRs) which are considered and finally adopted by the European Council in June 3 (See Box 7.1). In the aftermath of the financial and economic crisis, the locus of decision making on health systems has perceptibly shifted in a way that decisions are being taken now along the interface between European institutions and Member States.(24-26)3 For a comprehensive user friendly introduction to the European Semester process, the reader is referred to Chapter 5 in ‘Everything you always wanted to know about European Union health policies but were afraid to ask’ Greer, S et al 2014

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Europe 2020 is the European Union’s ten-year growth and jobs strategy that was launched in 2010. It is intended to overcome the crisis and create the conditions for a smart, sustainable and inclusive growth. Five targets have been set for the EU to achieve by the end of 2020. These cover employment; research and development; climate/energy; education; social inclusion and poverty reduction. The Europe 2020 strategy is implemented and monitored in the context of the European Semester which is the yearly cycle of coordination of economic and budgetary policies. The European Semester is an EU-level policy co-ordination tool contributing towards the broader EU aims of strengthening economic governance and greater policy co-ordination. It provides a more integrated surveillance framework for the implementation of fiscal policies under the Stability and Growth Pact as well as the implementation of structural reforms through national reform programmes. The Annual Growth Survey launches the European Semester by setting out the broad EU economic priorities for the year to come. It is the first step in the annual cycle each November.The Council endorses the Country-Specific Recommendations for each Member State on the basis of Commission’s proposal. The recommendations are based on a thorough assessment of every Member State’s plans for sound public finances (Stability or Convergence Programmes, or SCPs) and policy measures to boost growth and jobs (National Reform Programmes, or NRPs).Countries that request financial aid from, the European Commission (EC), the European Central Bank (ECB) and the International Monetary Fund (IMF) also commonly referred to as the Troika, agree to an Economic Adjustment Programme (EAP) package. The economic adjustment programme seeks to address short- and medium-term financial, fiscal and structural challenges facing the specific country. Member States with an EAP are expected to adhere to the conditions set out in the programme as part of the conditional financial support. Countries in receipt of an economic adjustment programme do not receive additional Country Specific Recommendations for that particular year.Adapted from http://ec.europa.eu/europe2020/europe-2020-in-a-nutshell/eu-tools-for-growth-and-jobs/index_en.htm accessed on 25/11/14

Box 7.1 - Description of the ‘European Semester’

PURPOSE

The purpose of this study was to examine the manner in which health systems are being addressed in the European Semester process through an analysis of the CSRs. Specifically the following research questions were addressed.

1. What are the trends in CSRs addressing health systems? 2. How is the discourse on health systems being framed in the CSRs?3. Can any predictors for CSRs on health systems be identified?

The study therefore sought to assess the way in which health systems are being targeted for reform through documentary analysis of the CSRs and statistical analysis for potential predictor variables.

Analytical FrameworkA theoretical framework was formulated to develop a rationale for a scientific analysis of the CSRs. The framework draws upon key developments in health policy at European level as well as the contextual issues leading to the development of the European Semester process itself.



Trends in health CSRs in the European Semester Given the relative lack of visibility of health policy in the Europe 2020 strategy, it may be argued that health would not feature as a key consideration in the CSRs. There is also no legal or sanctioning power over health systems within the EU institutions. However the fact that health systems accounted on average for 9.0% of GDP in 2010 and that DGECFIN and the Economic Policy Committee have made projections for future sustainability of health and long term care in Europe, indicate a growing interest in this policy sector.(27-29) The document “Investing in Health”, the expert panel on Investing for Health and the Commission Communication on “Effective, accessible and resilient health systems”,(30-32) are instances of a more comprehensive interest in health systems at EU level. Council Conclusions adopted during the Hungarian (2011) and Lithuanian (2013) Presidencies (2011) have both called for senior health decision makers to engage with the European Semester process.

Framing of the policy discourseThe European Semester mechanism of monitoring and surveillance was developed, against the backdrop of ensuring that Member States essentially keep a healthy financial and economic profile.(26) Equally social exclusion has become an issue of concern particularly in countries mostly affected by the financial crisis.(33-34) Therefore sustainability of public finances and the need to strengthen social inclusion can both provide a rationale for the emergence of CSRs on health systems and act as plausible framing mechanisms.(35)

Potential predictors of CSRsGiven the motive for the establishment of the European Semester process, lack of sustainability in health systems should intuitively be a strong driver triggering the development of health related CSRs and recommendations on health system reforms. Therefore it is reasonable to assume that countries manifesting trends of a growth in the proportion of public health sector expenditure relative to economic growth should be associated with a higher chance of obtaining a health CSR. Rapid growth in public health expenditure relative to denominators such as Gross Domestic Product (GDP), Total Health Expenditure (THE) and General Government Health Expenditure (GGHE) may increase the chances of obtaining a health CSR due to their impact on sustainability of public finances. The state of the general public finances could also well be a driver for health related CSRs given the economic significance of the health sector. Future projections of the ratio of PHE growth may also theoretically drive the issuance of health CSRs in relation to future sustainability of public finances. The Ageing Report 2012 provides a useful starting point for this analysis as different scenarios (e.g. reference

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[constant] scenario, risk scenario)4 can be examined. In these scenarios projected increase in public health care expenditure until 2060 as a proportion of GDP can be considered as a predictor variable. Assuming that the process is driven practically entirely by the financial and economic stability agenda then health system performance in terms of health outcomes would not be expected to have any effect on the likelihood of receiving a health CSR and these domains are not examined in this study.

METHODS

The rationale explained above was used to elaborate a mixed-method approach to the analysis of the CSRs. The English versions of the final CSR texts (or Economic Adjusment Programmes (EAP), or Memoranda of Understanding (MOU)) were retrieved from the official website of the EU in in October 2014.(36) The analysis involved all 27 Member States excluding Croatia (which was not eligible during the entire period under examination). A total of 108 documents were analysed.

Trends AnalysisA descriptive content analysis with a search for the key words and phrases “health”, OR “health care”, OR “long term care” was performed. A summative content approach was adopted. A number of countries did not receive CSRs for certain years since they were already in receipt of specific guidance through their EAPs. For these countries the EAP itself or the Review of the EAP published nearest to the date of the Council Recommendations with CSRs for other Member States was taken as the documentary source of analysis.

Detailed Content analysis

Framing of the CSRsThe second step involved the analysis of the context in which the CSRs regarding health systems were embedded. The CSRs containing the identified key words were categorised according to whether the health system recommendation was a “stand alone” subject or whether it formed part of a recommendation addressing another policy sector. This method has been used elsewhere (37) and was deemed important in order to understand the context in which health systems are being framed in the CSR language. Proponents of discourse analysis as a technique for understanding Euopeanisation of policy, emphasise the need to complement a simple deductive approach with a broader analysis that seeks to attach meaning to the context and circumstances of the language being used in the policy documents.(38)

4 For a detailed explanation of the reference scenario and risk scenario see Ageing Report 2012



Classification of actual CSR contentFurther detailed content analysis of the extracted paragraphs was then carried out in order to examine the specific health system functions/ goals featuring in the health CSRs. Components addressing “health”, “health care” and “long term care” were classified using two distinct analytic processes. The thematic analyses were conducted separately by two of the authors. Differences in the classification were highlighted and the final classification was decided upon during a consensus meeting.

Framework 1 (Access, quality, sustainability)CSRs were classified according to whether they were targeting access, quality or sustainability in line with the framework used by the Social Protection Committee since 2001.39) Where an objective was aimed at addressing more than one of these themes, it was listed separately, repeatedly, under each of the themes being addressed.

Framework 2 (Hit report template)CSRs were reanalysed using a different framework to triangulate the findings and increase the validity of the results. For this analysis, the template elaborated for describing health care systems in the HiT reports by the European Observatory on Health Systems and Policies (40) was used namely; organisation and governance, financing, physical and human resources, and provision of services. Since EAPs were produced in a particular set of economic circumstances and since the text is not comparable in form, style or content to that of the CSRs, the EAPs were not included in this detailed qualitative analysis. In the case of Romania and Latvia, for specific years where CSRs were not published, reference was made to the Council Decisions and accompanying Memoranda of Understanding. The structure of these documents was deemed sufficiently similar to the CSRs in format to be included in the analysis.

Statistical analysis for variables associated with health CSRs

Potential predictor variablesThe objective of this analysis was to identify any variables associated with the likelihood of health CSRs being issued to a Member State. Predictor variables selected included typical health systems performance expenditure indicators as well as general economic and fiscal indicators. Each of the 27 MS was assigned a binary outcome for 2011, 2012, 2013 and 2014 respectively depending on whether they had a health CSR (1) or not (0). The data for the predictor variables was extracted from the WHO European Health for all Database and EUROSTAT database in October 2014. The following variables were tested using binary logistic regression;

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• GDP per capita in PPS• Public sector expenditure on health as a % of GDP (PHE % of GDP)• Public sector expenditure on health as a % of total health expenditure (PHE as a

% of THE)• Public sector expenditure on health as % of total government expenditure (PHE

as a % of TGE)• Total health expenditure as % of gross domestic product (GDP) (THE % of GDP)• Total health expenditure in PPP$ per capita (THE in PPP$ per capita)• Government deficit/surplus % of GDP• Total general government expenditure as a % of GDP• General government gross debt

Past trends in public health expenditurePast trends in public health care expenditure were analysed against the likelihood of obtaining a health CSR since it was thought that the rate of change of expenditure could be a potential predictor variable. As a result of the small sample size, the non-parametric test, Spearman’s Rho correlation, was performed to analyse the correlation between the total number of CSRs issued over three years for each MS (0,1,2,3 or 4) with the average annual percentage growth rate for the following three proportions (PHE/GDP, PHE/THE, PHE/GGHE, PHE growth rate and GDP per capita growth rate) for the period 2008-2012. Separate models were carried out to test each association.

Future forecasts in public health expenditureFor an analysis of the effect of future projections on the likelihood of getting a health CSR, use was made of the reference and risk scenarios for public health expenditure as a % of GDP in 2060 elaborated in the 2012 Ageing Report. Here associations were also tested using the non-parametric test Spearman’s Rho as outlined in the preceding section.

RESULTS

Prevalence of health CSRsThe results of the analysis for the presence of the terms “health”, OR “health care”, OR “long term care” within CSRs, EAPs or MoU are shown in Table 7.1. There is a clear trend for health recommendations increasingly to feature in CSRs. Six countries have not had a health related CSR to date.



Table 7.1 - Member States issued with health system recommendations through CSRs*Year 2014 2013 2012 2011Austria Y Y Y YBelgium Y Y Y NBulgaria Y Y Y NCyprus Y (EAP)a Y (EAP)a Y YCzech Republic Y Y N NDenmark N N N NEstonia N N N NFinland Y Y N NFrance Y Y N NGermany Y Y Y YGreece Y (EAP) Y (EAP) Y (EAP) Y (EAP)Hungary N N N NIreland Y Y (EAP) Y (EAP) N Italy N N N NLatvia Y N N Y (MOU)Lithuania Y N N NLuxembourg Y Y N NMalta Y Y N NThe Netherlands Y Y Y YPoland Y Y N NPortugal Y Y (EAP) Y (EAP) Y (EAP)Romania Y Y Y (MOU) Y (MOU)Slovakia Y Y N NSlovenia Y Y N NSpain Y Y N NSweden N N N NUnited Kingdom N N N NTotal 21 19 10 8

*This includes reference to the health or long-term care as part of a CSR addressing another policy sectorEAP – Economic Adjustment ProgrammeMOU – Memorandum of Understanding

Framing of CSRs on health and long-term careIn 2013, for the first time, four countries had a CSR which was specific to health or long-term care. The results are shown in Table 7.2. For this analysis, the EAP and MoU countries were excluded since the format of the recommendations is not comparable.

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Table 7.2 - Framing of Country Specific RecommendationsMain theme 2014 2013 2012 2011Health or Long-term care 3 4 1 0Pensions and social security 7 4 1 1Education 0 1 0 0Sustainability of public finances 6 6 4 3

Classification of CSRs by contentResults shown in Table 7.3 demonstrate that sustainability is the most frequent theme using the access, quality, sustainability classification whilst financing is the most frequent theme using the Hit report classification. A single CSR may have been assigned to more than one category depending on the language used and target of the health system reform. The actual language being used is depicted in the verbatim excerpts of the CSR text available in the online appendix. Increasing cost-effectiveness and curbing age related expenditure are two of the most prevalent themes encountered. A consistency in the CSR wording from one year to the next appears.

Table 7.3 - Classification of CSR content by policy objective and health system domain*Policy objective Health System Domain Number of CSRs

Access 12Quality 11

Sustainability 42Organisation and governance 18

Financing 40Physical and human resources 0

Provision of services 15

* A single CSR has sometimes been classified into multiple objectives or domains

Potential predictors of health CSRs General economic and fiscal indicators were tested against the association with CSRs. Although not health specific, it was deemed possible that these indicators may play a role in the issuance of health CSRs since these are mainly linked to sustainability of public finances. The odds ratio of obtaining a health related CSR increased slightly with the increase in level of general Government debt, with an OR 1.02 (CI: 1.01, 1.03 p=0.007) per 1% increase in General Government gross debt. The only association observed between variables of health system financial performance and health CSRs was for the share of public health expenditure as a proportion of total health expenditure where the Odds Ratio of obtaining a CSR decreased with an increased public health expenditure/total health expenditure ratio, with an OR 0.89 (CI: 0.84, 0.96 p=0.001) per 1% increase in Public Health Expenditure as a % of Total Health Expenditure. This relationship



remained present when both variables (General Government gross debt and Public health expenditure/total health expenditure) were put into one model. These results are presented in Table 7.4.

Table 7.4 - Results from binary logistic regression with presence of CSR as outcome variableParameter Odds Ratio CI P-valueGDP per capita in PPS 1.00 (0.99-1.01) 0.966Public sector expenditure on health as a % of GDP 0.97 (0.78-1.20) 0.752Public sector expenditure on health as a % of total health expenditure

0.89 (0.84-0.96) 0.001*

Public sector expenditure on health as a % of total government expenditure

1.00 (0.87-1.15) 0.983

Total health expenditure as a % of gross domestic product (GDP)

1.09 (0.88-1.34) 0.438

Total health expenditure in PPP$ per capita 1.00 (1.00-1.00) 0.340Government deficit/surplus as a % of GDP 0.98 (0.90-1.08) 0.738Total general government expenditure as a % of GDP

0.97 (0.92-1.03) 0.352

General government gross debt 1.02 (1.01-1.03) 0.007*Joint analysis of general government gross debt and public health expenditure as a % of total health expenditure

1.03

0.92

(1.01-1.04) (0.86-0.98)

0.004*

0.011*

As a result of this unexpected result, to further understand the relationship between Public Health Expenditure as a % of Total Health Expenditure and the issuance of a CSR, the ratio PHE as a % of THE was subdivided into four quartiles with the lowest ratio of PHE/THE being represented as Q1 and the highest ratio being represented as Q4. While no significant differences were observed between countries falling into the first three quartiles of public health expenditure as a % of THE in terms of obtaining a CSR, the likelihood of obtaining a CSR when a country’s PHE/THE ratio was within the 4th (highest) quartile decreased to 9.5%. Countries falling into this category were significantly less likely to obtain a CSR when compared to each of the other quartiles. It was further noted that out of the six countries that never received a CSR, four have their PHE/THE ratio in the highest quartile. Further material is provided in the online appendix to the paper.

There was no relationship between the past annual rate of growth of public health expenditure or that of GDP and obtaining a health CSR. Given the importance attributed to the impact of ageing, the association between projected future public health expenditure for the reference and risk ageing working group scenarios modelled until 2060 and the number of CSRs was tested. Here again no significant associations were observed. The results are reported in Table 7.5.

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Table 7.5 - Association between trends in public health expenditure growth and number of CSRs Parameter Spearman’s Rho p value% annual average growth rate GDP per capita 2008-2012 vs Total number of health CSRs (2011-2014)

-0.11 0.60

% annual average growth rate Public health expenditure 2008-2012 vs Total number of health CSRs (2011-2014)

0.03 0.88

% annual average growth rate Public health expenditure /GDP 2008-2012 vs Total number of health CSRs (2011-2014)

-0.04 0.86

% annual average growth rate of Public Health Expenditure as a % of Total Health Expenditure 2008-2012 vs Total number of health CSRs (2011-2014)

0.11 0.60

Projected increase in Public health expenditure /GDP 2010-2060 (AWG Reference Scenario) vs Total number of health CSRs (2011-2014)

0.02 0.93

Projected increase in Public health expenditure/GDP 2010-2060 (AWG Risk Scenario) vs Total number of health CSRs (2011-2014)

-0.11 0.58

DISCUSSION

Previous work has noted an increased involvement of the EU in the financial governance of health systems albeit without more specifically analysing the policy tools used.(41) Using CSRs as a data source we analysed the way health systems are being addressed through the European Semester process. An increasing ‘socialisation’ of the Semester has been noted although the ubiquitous emphasis appears to be on sustainability.(42)

Aside from the specific situations in countries relying on financial assistance and bail outs, this analysis has shown that health systems in general are coming under increasing scrutiny by the European institutions. Health and long-term care are gaining visibility as policy issues in the European semester as they are also attracting CSRs in their own right. A hierarchy of health policy objectives is emerging with sustainability becoming supreme to access and quality, departing from the balanced triad of policy objectives promulgated through the Open Method of Coordination or the focus on key values for European health systems.(39,43-44) Health system CSRs are framed as a means to the objective of ensuring sustainability of public finances and not as part of the pillar on combating poverty and social exclusion. The analysis also indicates a shift away from concentrating only on the financing of health systems as a lever for policy reform but shows how health care organisation and delivery is also recently being targeted as an area for policy reform. The study has confirmed that to date it was not possible to discern an association between health performance indicators related to public expenditure and sustainability of health systems and the issuance of health CSRs. However an association was observed between the level of general country debt and health CSRs indicating that



the performance of the health system is a secondary consideration to the overall country financial situation.

Financing and sustainability are dominating the discourse on health systems. This possibility had been alluded to in an analysis outlining how health systems will be influenced by the EU’s policy agenda post financial crisis.(14) The hierarchy and subordination of policies within the European institutions is not something new and has been reported elsewhere confirming the observed tendency of linking health goals more closely to the EU’s economic growth narrative rather than valuing the health policy objectives in their own right.(17,42,45) Despite the existence of official documents supporting the need to invest in healthinvestments in health infrastructure and human resources as a pre-requisite for economic growth do not feature as a priority.(30) While the narrative of the European Semester promotes investment in education and research, health and long term care systems are referred to in terms of a policy challenge.(36)

The CSRs recommending controls in health care spending are also likely to affect the prospects of job creation in the health sector running counter to the observation that the health sector is one of the important growth sectors for employment in Europe.(46) Zealous implementation of CSRs aimed to secure sustainability of public finances may well have spill over effects into fields such as employment. The process of CSR formulation does not appear to be one driven by traditional metrics of health system performance but seems to be influenced by several factors which may include lobbying and negotiation by the Member States themselves but equally between the different Commission DGs, each with its own specific mission, objectives and line of expertise.(47) Given the importance attributed to the Ageing Report projections, it was surprising that the health care spending projections were not associated with the odds ratio of obtaining a health CSR. The evolving situation where countries are increasingly under pressure to implement their CSRs to be viewed as coming in line with the advocated norms for financial and economic policy objectives makes it even more imperative that the CSRs are informed by appropriate evidence both in their genesis as well as for their potential health impacts. Increased transparency in the process leading up to the formulation of CSRs for health systems should be considered by the EU institutions involved in the process which has been acknowledged to be a relatively new process which is still being fine-tuned.5 Health experts and decision-makers would do well to engage more actively in shaping the processes of the European Semester. The explicit call for work on health systems performance to inform the European Semester appears to acknowledge the need to continue to refine and develop the process of CSR elaboration.(48) The expert group on Health Systems Performance Assessment has an important role to play such

5 Emphasis was made on the fact that the process should be viewed as a learning exercise still needing refinement during a round table discussion that took place during a workshop on the European Semester organised at the European Public Health Conference, Glasgow, 21/11/2014.

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that the input into metrics for CSRs does not remain the quasi exclusive domain of the Economic and Social Policy Committees.(43) The Commission Staff Working documents drawn up to inform the CSRs are important policy statements but do not in themselves lead directly and certainly into CSRs. Indeed it has become quite pertinent to question why certain countries not attracting health CSRs. Examination of the actual text of the CSRs shows a certain consistency from one year to the next. It has become increasingly difficult to disentangle the extent to which the EU is pushing national health systems reforms through the Semester or whether Member States are riding on the back of the Semester to gain the additional Brussels based support for unpopular policy reforms at national level.(49) The European Semester appears to have irreversibly shifted the locus of decision making for health system reform from a purely national competence to one which is shared with the European institutions. The effect of this top-down approach on the existing mechanisms of health systems stewardship at national and regional level remains to be seen. On the one hand the excessive focus on fiscal sustainability may have a negative impact whilst on the other hand the top down pressure for reform may result in an opportunity to tackle long-standing issues for which there was insufficient political will or technical resource in the past.(50)

Strengths and LimitationsThis study has the following strengths. The content analysis made use of two separate policy frameworks to triangulate the evidence and the complete set of CSRs was examined over a four year period. Earlier versions of this paper were presented at a meeting on The International Dimension of Collaborative Health Systems Research in May 2014 and at the European Public Health Conference in November 2014 where discussion between key stakeholders served to provide information on the evolving nature of the European Semester process and indications for future research. The study is only a preliminary attempt to describe a process that due to intrinsic complexity and the presence of several confounding factors can be only partially undergo objective analysis. It is possible that trends will emerge over the next couple of years as the power of the sample under investigation increases. On the other hand methods such as qualitative comparative analysis could form an alternative approach to the analysis and will be considered in future work. The assumption that the presence of a CSR is linked to recommendations on health system sustainability is also a limitation given that a few CSRs do focus on aspects of access and quality. This confounding factor may have also served to dilute the real effects. Health and long-term care recommendations were analysed together as health system reforms. A separate analysis of these two policy areas would be important as the number of CSRs available for analysis increases.



Further research

The production and subsequent evaluation of the National Reform Programmes and the Convergence and Stability Programmes are tangible products of the policy making interface between national and EU level decisions. The manner and direction in which European health systems are being steered and the extent to which the European Semester is shaping health system reform in practice is an important area for further research.

CONCLUSIONS

Health systems policy and reform no longer takes place entirely at national level. Whilst interdependence has become unavoidable for public health to progressit is important to ensure that the manner in which health systems are steered through the European Semester process focusses on improving health system performance as a means to improve the health of European citizens.(51) The setting up of an expert panel to provide advice on Investing in Health is a step in the right direction.(31) Getting this expertise into the heart of the decision making processes in the European Semester to bring about a better informed health-informed approach to evaluating health issues within the European Semester is the next challenge. There is a need to rebalance the discourse at European level so as to duly recognise that health systems are not merely a burden on public finances for Europe. The Annual Growth Survey 2014 mentions health together with pensions as being areas requiring attention to efficiency and sustainability whilst ensuring access to high quality services.(52) Whilst this statement augurs well for retaining the balance between the policy objectives of access, quality and sustainability, the fact that all the CSRs for pensions and health are captured under the heading of sustainability of public finances and not that of employment and social policies leads to the conclusion that the debate at European level remains skewed. More active engagement of health decision-makers is required. Further coordination by European Union institutions should be geared towards supporting Member States to take the best decisions possible, decisions which will lead to the maximisation of health gain and improvements in health status for Europe’s citizens. This spotlight on health systems may be turned into an opportunity for a new paradigm in the process of health policy development at European level since it appears unlikely that health systems scrutiny by the EU institutions will be reversed even with a return to economic growth.(3) The possible impact of this development on Europe’s health systems and their common values remains to be seen and a full impact assessment of the European Semester process on health systems reform in Europe may be a timely consideration.(44)

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42. Submitter BU, Zeitlin J. Socializing the European Semester? Economic Governance and Social Policy Coordination in Europe 2020. Economic Governance and Social Policy Coordination in Europe 2014; 2020.

43. Council of the European Union. Health Systems Performance Assessment - Terms of Reference for an Expert Group Outcome of Proceedings 12945/14. 2014; Available at: http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%2012945%202014%20INIT. [Accessed December 2, 2014.]

44. Council of the European Union. Council Conclusions on Common values and principles in European Union Health Systems (2006/C 146/01). 2006.

45. Borg A.M. Health Inequalities amidst the Economic Crises and Austerity: An issue for EU Policy-Making. 2012.

46. European Commission. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions -Towards a job rich recovery 2012.

47. Dobrovolny M. Health in Slovakia in the framework of the European Semester. 2014; Available at: http://ec.europa.eu/slovensko/documents/presentation_sk_health_care.pdf. [Accessed December 2, 2014.]

48. Juncker J. Mission Letter Vytenis P. Andriukaitis Commissioner for Health and Food Safety. 2014; Available at: http://ec.europa.eu/about/juncker-commission/docs/andriukaitis_en.pdf. [Accessed December 2, 2014.]

49. Azzopardi-Muscat N, Brand H. The ‘European Semester’–a growing force shaping Health Systems Policy and Reform in the European Union. The European Journal of Public Health 2014; 24(suppl 2):cku164. 089.

50. EUPHA O 5 Round table: Is the ‘European Semester’ becoming the major driver for health systems policy development in Europe? Eur J Public Health 2014; 24:2.


52. European Commission. Communication from the Commission Annual Growth Survey 2014 COM (2013) 800 final. 2013.

CHAPTER 8General Discussion

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General Discussion | 165

SUMMARY OF MAIN FINDINGS

This dissertation set out to explore how the EU (EU) influences health systems, from the perspective of a small Member State. During the period that work on this thesis was carried out, the EU was grappling with the financial crisis. In addition, the adoption of the cross border directive, the influenza pandemic, the Ebola outbreak, the ‘Arab Spring’, the conflict in the Middle East and the ensuing mass displacement and migration of persons are all critical occurrences that have altered the environment within which European health systems operate over the past five years.(1-3) Small states are known to be particularly vulnerable to the effects of these types of exogenous shocks resulting from political, economic or environmental crises.(4) Research on small state health systems and the manner in which they are impacted by EU policy is therefore timely as European policy-makers seek solutions to strengthen health system resilience in the face of extraordinary challenges.(5-7) In this chapter the main findings are summarised and discussed together with the methodological approach adopted and its limitations. Implications of the findings of this thesis for research, policy implementation and practice are presented.The following are the main findings that emerge from this thesis (Figure 8.1).

The synthesis of the available literature on health systems in small EU Member States showed that small states experience certain common challenges mainly as a result of their lack of human and resource capacity. This lack of capacity impinges on aspects of governance, self-sufficiency in the provision of specialised health services and effective implementation of health system reform. In this respect we cite examples of the EU acting as an important driver of health system reform in small states. Secondly, the Maltese case study provided evidence that EU accession is a powerful stimulus for health system reform driven primarily through the necessity for legislative compliance and institution building. Sectors over which the EU has a long-standing experience of competence and regulation, such as medicines and mutual recognition of professional qualifications, underwent significant transformation. Over a decade of EU membership, the public health workforce experienced the benefits of networking and capacity building. On the other hand, the organisation, financing and delivery of health services were mainly unaffected by EU membership. Contrary to the traditional narrative that stakeholders resist an active EU role in health systems, this thesis found that domestic stakeholders in Malta actively sought to use the EU to implement desired norms. Generally, they also want a more effective and visible role for the EU in health policy and health system stewardship. This desire for the EU to assume a greater role in health policy is viewed as being necessary to overcome local inertia and resistance to health system reform as well as to enlarge the capacity of a small state to tackle serious public health problems. The

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caveat here is that a one size fits all approach is problematic and a better understanding of the specificities of small states is deemed necessary. Finally through policy analysis of recent developments at EU level, this thesis found that the ‘Communitarisation’ (8) of health policy in the EU is an ongoing endeavour despite the fact that health is a Member State competence that is further safeguarded by the principle of subsidiarity. However the vigour and success of this policy development appears to be fashioned by chance and crisis rather than by intentional design. The research in this thesis shows that recent EU policy developments with implications for health systems seem to be more strongly driven by objectives linked to fiscal and economic governance or neoliberalism, than by reference to public health needs and supporting evidence. The EU has the potential to support small state health systems through the elaboration of appropriate policies and programmes, yet many of the initiatives taken to date have not had substantial impact on domestic health systems.

191

reform as well as to enlarge the capacity of a small state to tackle serious public health problems.

The caveat here is that a one size fits all approach is problematic and a better understanding of the

specificities of small states is deemed necessary. Finally through policy analysis of recent

developments at EU level, this thesis found that the ‘Communitarisation’ (8) of health policy in the

EU is an ongoing endeavour despite the fact that health is a Member State competence that is

further safeguarded by the principle of subsidiarity. However the vigour and success of this policy

development appears to be fashioned by chance and crisis rather than by intentional design. The

research in this thesis shows that recent EU policy developments with implications for health

systems seem to be more strongly driven by objectives linked to fiscal and economic governance or

neoliberalism, than by reference to public health needs and supporting evidence. The EU has the

potential to support small state health systems through the elaboration of appropriate policies and

programmes, yet many of the initiatives taken to date have not had substantial impact on domestic

health systems.

Figure 8.1 - Summary of main findings from dissertation Figure 8.1 - Summary of main findings from dissertation



DISCUSSION

The research questions set out in the introductory chapter have all been addressed in this dissertation.

In Chapter 2, a literature map on health systems in small EU MS was presented. The review found that despite their geographic and economic heterogeneity, small EU states experience certain challenges in line with evidence provided by several small state studies outside the health sector.(9-12) Lack of capacity and small market size, ultimately the absence of conditions for the exploitation of economies of scale, constrain health system governance and limit delivery of highly specialised health services thereby forcing small states into seeking modified forms of self-sufficiency. Furthermore, lack of capacity appears to detract from the ability to effectively implement and sustain health system reform. Health system reform in small states tends to be initiated by circumstances external to the health system. Political transition, the financial crisis and the EU accession process were identified in this study as examples of triggers for health system reform. The review found a gap in the literature on the influence of the EU, i.e. what can be called Europeanisation, of health system developments and reforms in small states.

Chapters 3, 4 and 5 together constitute the case study exploring Europeanisation of the Maltese health system. They mainly address the afore-mentioned research gap. It was observed that Europeanisation occurred to varying extents within the Maltese health system. This study showed that that public health elements and sectors that are regulated by internal market directives are far more affected than other aspects pertaining to service delivery. This aspect of the analysis confirms work carried out previously by other scholars.(13-15) Chapter 3 provided the necessary in-depth description of the context within which the empirical research presented in Chapters 4 and 5 was conducted. The main challenges identified in the Maltese health system include capacity constraints leading to problems such as long waiting times and hospital overcrowding as well as a weak primary care system and insufficient attention to reforms to address financial sustainability. Based on this health system review carried out using the standardized methodology of the Health Systems in Transition (HiT) series, it was possible to trace the principal reforms that occurred in the Maltese health system in the preceding decade.(16) Major reforms were implemented in the areas of human resources and medicines regulation during the EU accession process which entirely changed the regulatory landscape of these two sectors. Other reforms occurred in aspects pertaining to public health governance whilst the system of financing remained unchanged. Findings from the qualitative study of domestic stakeholders reported in Chapter 4 confirmed that the implementation of directives associated with the accession process was an important opportunity for reform in the structures and systems for post-graduate medical

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qualifications and training as well as the amelioration of legislation covering standards in the area of medicines’ regulation. This case study of domestic stakeholders also found that the EU exerted an important indirect influence on policy-making, as exemplified by the fact that a number of important public health strategies were adopted in the years following EU accession, which stakeholders attributed to indirect ‘pressure’ from the EU. It is important to emphasise that this pressure appears to be entirely different from the pre-accession pressure to comply with legislation and standards related to the internal market and appears to be driven largely by social learning and a desire to emulate what are perceived as European norms and good practice. This study also confirmed findings from the Hit review that the health services delivery component of the health system was deemed to be mostly unaffected by the EU. The sense of regret expressed by domestic stakeholders that EU membership did not lead to substantial reforms in service delivery, notably in the primary care sector, emerged as a particularly striking phenomenon. Domestic health system stakeholders thus appear to cultivate a ‘love/hate’ relationship with the EU. Whilst a desire for a greater involvement of the EU in health policy and health systems was highly visible, a sense of disappointment arising from the inability of the EU to implement certain public health initiatives, be it due to the lack of competence or the low priority accorded to health policy at EU level, was also evident. Stakeholders positively view the EU for providing support networks which are vital to counteract professional isolation in a small state setting. Somewhat ironically, the EU is also viewed positively as an external force capable of overcoming domestic sources of resistance to reform. On the other hand, domestic stakeholders in a small health system flounder under the administrative burden associated with implementing uniform EU obligations, and this is mainly attributed to a lack of understanding of specificities encountered in small state health systems and the ‘one size fits all’ approach. Stakeholders also feel the pressure to keep up with what they perceive as EU public health norms within a situation of highly limited capacity and resources. The ‘love/hate’ relationship is depicted through the in-depth case study of the implementation of the patients’ rights and cross border care directive in the Maltese health system described in Chapter 5.(17) This study showed how a high level of anticipated negative impact of the directive particularly on the longer-term health system sustainability, led domestic stakeholders to adopt a highly defensive approach in the transposition of EU law so as to limit patient mobility. However, public officials simultaneously also appear to have acted as norm entrepreneurs by seizing the opportunity to overcome certain domestic inertia to reform and implement legislation on patients’ rights, the clarification of entitlement and indemnity insurance. The obligation to fulfil the directive thus gave them added strength to argue for the implementation of certain norms and standards. The case-study illustrated how in the Maltese health system, Europeanisation occurs through both passive downloading and active utilisation of EU rules.(18)



Chapters 5, 6 and 7 provide an analysis of ongoing health system policy developments at the supranational level, i.e. Communitarisation initiatives, namely: the patients’ rights and cross-border care directive, the joint procurement agreement for medical countermeasures and the evolution of country-specific recommendations on health and long-term care within the European Semester. The de facto domestic impact of these initiatives to date appears to be negligible. However, stakeholders fear that the increasing importance of the European Semester may impact on the model of health system financing in future. The implementation of the patients’ rights and cross-border care directive in the Maltese health system is more noteworthy for the impetus it gave to the implementation of certain health system reforms (as explained above) than for any appreciable impact on patient mobility. The EU Joint Procurement Agreement has not actually been used to buy any medicines or vaccines to date and it is doubtful whether there is the sufficient level of support to enable the mechanism to have a meaningful impact on domestic health systems. Indeed analysis of this policy initiative established that while it exhibits some strong features such as country-ownership, transparency, equity and flexibility, it appears doubtful at this early stage, whether it gives the member states sufficient incentives to convince them to make a sustained commitment to it. This is particularly the case for larger Member States that have sufficient capacity and economies of scale to procure medicines and counter-measures on their own. This initiative is therefore considered to be rather weak. Since it is not centrally resourced, its success is highly dependent upon the zest and motivation of public health technocrats at domestic and EU level. Should it fail, smaller MS will lose more than larger ones. This policy initiative presents a typical example of how health policy initiatives at EU level may be initially driven by small MS but the power and effectiveness of these small states to actually sustain initiatives at EU level is doubtful in the absence of an appropriate legal and political framework. The third example which is presented in Chapter 7 deals with the strand of fiscal and economic governance. The analysis of the Country Specific Recommendations (CSRs) on health and long-term care, generated through the European Semester mechanism, showed that Europeanisation of health systems is gaining in importance on the policy agenda confirming evidence that health systems policy-making and reform no longer take place entirely at national level, but are increasingly steered also at EU level.(19) This study concluded that the process of developing and issuing a CSR is a politically complex one that cannot be explained in terms of health systems performance. It is demonstrated how there is an increasing trend for health systems to feature in CSRs which tend to be framed in the discourse on the sustainability of public finances rather than that of social inclusion, with a predominant focus on the policy objective of sustainability.

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WHITHER EUROPEANISATION OF THE HEALTH SYSTEM?

Referring back to the conceptual framework presented in the introductory chapter (Chapter 1 Figure 1.1) this section discusses the relevance of the findings of this thesis for health system Europeanisation. The examples of ongoing health policy development initiatives at EU level demonstrate the active development of this policy area in spite of the limited EU competence in health systems or the fact that the Juncker Commission considers health as one of the policy areas that had better be left to Member States to administer.(20) Two key issues that need to be addressed in any evaluation of health system Europeanisation are:

1. How EU policy developments are initiated 2. The degree of support for Europeanisation at the domestic level.

According to Greer, Europeanisation is “uninvited” and follows a neo-functionalist approach with evidence of the spill-over effect.(21) Vollard sees the future development of EU health policy through a federalist perspective.(22) In this dissertation, analysis of the development of the Joint Procurement Agreement for medical countermeasures fits neo-functionalist theory confirming the stance taken by Greer. On the other hand, the aspirations of several domestic stakeholders in the Maltese health system vis a vis the future of European health policy appear to be markedly federalist in nature supporting the vision developed by Vollaard. However, as a whole, the picture that emerges from this thesis with regard to the development of EU health policy is one of political opportunism whereby European health policy appears to be emergent rather than intentional. Indeed, the patients’ rights directive was the culmination of a series of disparate rulings by the European Court of Justice which saw their beginnings in the cases filed by Kohll and Decker, the Joint Procurement Agreement which was introduced in response to the 2010 influenza pandemic and the health system country-specific recommendations that emerge from the European Semester which owe their existence to the financial crisis more than anything else.(23-24) Therefore, overall findings from this thesis support the conclusions by Lamping and Steffen that health policy elaboration at EU level is an “issue-specific, fragmented and incremental process, still patchy rather than systematic and consistent”.(25)

The analysis of the domestic impact of the EU on the Maltese health system using the four types of outcomes which have been described in the Europeanisation literature found evidence of both continuity and change.(26) In general, several domains of the health system exhibited features of inertia or adaptation such that a minimal transposition and implementation is carried out without any radical effects on the health system. This incrementalism can be explained in terms of a relatively high “goodness of fit” existing prior to EU accession.(27) The major changes are observed in areas such as medicines regulation or cancer services where adaptation pressure was very high due to a high



degree of ‘misfit’.(28-29) At the same time, domestic stakeholders saw this as a window of opportunity to bring about desired change since the EU norms and values were aligned with those of the domestic policy makers. The pathway of regulatory compliance features most prominently in the implementation of directives and was particularly associated with the conditionality associated with the accession process in line with the process described by Scimmelfennig and Sedelmeier.(30) However, ongoing Europeanisation in the Maltese health system appears to be driven primarily through emulation of norms or policy diffusion as well as mechanisms including benchmarking, networking, projects and capacity building. This confirms the importance of new forms of governance described by Radaelli and policy diffusion portrayed by Borzel, both emerging as the dominant modes of ongoing Europeanisation in the Maltese health system.(31-32)

This thesis also found that domestic stakeholders intervene at a critical stage to shape the influence of the EU in line with the observations made by Woll.(33) For example, the drawing up of the National Health Systems Strategy in Malta was a condition which had to be fulfilled in order to enable Malta to use EU funds for the health sector in the period 2014-2020. Concurrently, domestic stakeholders used this opportunity to update the national health policy document published in 1995. The development of the Health Act, framework legislation that separates regulatory and service provision in the public health system, was also facilitated by the opportunism of civil servants riding on the back of the necessity of transposing the patients’ rights and cross border care directive. This political opportunism is also seen in the area of service delivery, which while remaining primarily a national level responsibility, may be influenced through the use of EU funds as illustrated by the development of the oncology facility in Malta.(34) When EU norms and values and the interests of domestic actors are aligned, non-binding instruments such as the Council recommendation on cancer screening are actively promoted often through an advocacy coalition framework involving experts and civil society.(35-36)

On the other hand, domestic stakeholders downplay the importance of recommendations that may not be aligned to the political objectives and discourse at national level. For example, the repeated focus on health system sustainability emerging from EU Commission assessments of the Maltese health system did not trigger any major health financing reforms and is viewed as being off-limits for the EU. While Malta and other MS which have not been forced to adopt an economic adjustment programme have not really witnessed any impact on their method of health care financing, this thesis found evidence that domestic stakeholders fear that this may change in the future thus leading them to take up a pre-emptory defensive stance to preserve the social welfare-based health system and carefully guard against transfer of competences to the EU level. A similar observation has been made by Vollaard who considered the EU’s economic and fiscal governance infrastructure as disenfranchising popular support for the EU and stunting further health system Europeanisation.(22) Nonetheless there is a need

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to highlight the fact that whilst the European Semester mechanism is driven by the Commission Directorate responsible for Economic and Financial affairs (DG ECFIN), it would be somewhat naïve to assume that the sustainability agenda is only being driven by European technocrats, for it is more than likely that it also reflects the input from officials in Member States. Circular and horizontal mechanisms of influence are likely at play rather than solely a vertical top down approach once again lending support to the theory that domestic stakeholders are not merely passive downloaders of EU rules but actively use the EU to meet their own policy agendas.(18)

Therefore both pressure from the EU on the domestic system and active usage of the EU by the domestic stakeholders are relevant to the analysis of Europeanisation of the Maltese health system. EU influence is evolving from regulatory compliance towards policy learning by nudging forward change through benchmarking. The most recent EU Commission initiatives in the area of Health System Performance Assessment and health system benchmarking using the Joint Assessment Framework under the auspices of the Open Method of Coordination within the Social Protection Committee confirm this trend.(37-38) Indeed this thesis found evidence that health system Europeanisation as well as Communitarisation, are ongoing, even though consistent with Vanhercke, these activities are taking place ‘under the radar’.(38)

Added value of the EU to small MS health systemsOne of the key limitations of small states is the lack of resources and therefore capacity building can help enhance their resilience. The role of the EU in assisting a small state to overcome its ‘vulnerabilities’ and strengthen its ‘resilience’ has been assessed by Pace who concludes that the EU has much to offer in providing support for a small island state like Malta.(39) Contrary to the notion that Europeanisation in health systems is ‘uninvited’, the results from the Maltese case study show a considerable level of support for EU intervention.(21) Overall, domestic stakeholders view the Europeanisation of the health system as a positive development and actually desire a greater EU influence than has hitherto been the case in certain policy areas. The expletive “Thank God for the EU!” or “Thank God there was an EU obligation!” commonly expressed by interviewees captures this sentiment of gratitude even for the obligation to implement certain reforms. This emotion was discernible among various stakeholders including politicians, public officials and members of civil society. The added value of the EU for small states therefore emanates from the enlargement of capacity, offering small European states an “escape from smallness.”(40)

The growing globalization and interdependence of the world’s health systems leaves no doubt that a small state finds it harder than larger states to confront certain issues in its quest to ensure an accessible, high quality and sustainable health system.(41) The



advances being made in medicine which often necessitate highly specialized care, or the quasi-monopolistic situations being created by large multi-national corporations, bring to the fore the formidable challenges in engaging with global health governance. The various sub-studies in this dissertation have shown that the EU has the potential to become an important player for health systems in small states not only in supporting Member States directly, but also by facilitating the process through which Member States can enhance mutual health system cooperation programmes. This dissertation has confirmed how institutions such as the European Centre for Disease Control, as well as networking and capacity building initiatives including Joint Actions, are welcomed since they assist policy makers in small Member States to overcome professional isolation and lack of capacity. Furthermore, benchmarking using European norms and standards appears to be valued by national public health experts. This supports previous findings that backing for an EU health information system appears to exist amongst technical experts working at EU level.(42)

The EU can also play an interesting role in supporting small states by providing them with the impetus to overcome inertia for reform. There is added value in having the external scrutiny or oversight from the EU in a context where internal debate and peer review is naturally limited as a result of small size. The Maltese health system case study illustrated how the most ambitious reform, namely that of the primary care sector launched in 2009 was not implemented due to the resistance encountered leading some domestic stakeholders to believe that an EU obligation to implement is a critical factor in driving health system reform.(43-44)

The EU however does more than just act as a stimulus to internal changes captured under the broader epithet ‘Europeanisation’. It can also provide small states with enhanced security perceived in the broader meaning of the term (i.e. includes human security). Health system reform and adaptation carried out pre-emptively at a national level can of course help to strengthen the buffers against externally originating shocks. But as Thorhallsson would argue, such a strategy alone might not be sufficient.(45) To ensure that small states do not have to face large challenges alone, as happened to Iceland during its financial crisis in 2008, they need bilateral alliances or multilateral ones. In the health sector, small states are continually exposed to challenges from the external domain which can easily dwarf their own capabilities. Drawing upon the concept of ‘shelter’ elaborated by Thorhallsson, (in the context of the financial crisis experienced by Iceland), as a system of underwriting a small state’s security, one can conceive that this model could be applied to health systems.(46)

But there is still much more that remains to be done for the EU to assume the role of shelter provider for small health systems and for the foreseeable future small states are still likely to depend upon bilateral alliances with larger states. Likewise, a stronger

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EU policy to address the global commercial determinants of health, for example the food industry, is perceived to be highly important to stakeholders in the Maltese health system because of the huge problem of childhood obesity. Similarly, stronger initiatives in the area of medicines policy, particularly by engaging with the industry directly at EU level to ensure that small states do not face access problems due to their small market size are also highly sought.

A model for health system Europeanisation in a small stateIn the light of the findings of this thesis, a model to describe the normative assessment of health system Europeanisation in a small state has been elaborated as shown in Figure 8.2. This model builds upon the concept of ‘goodness of fit’ and adds the element of degree of support offered by the EU towards small states versus the administrative burden. Health system Europeanisation is viewed most positively and receives the greatest degree of support where there is a high level of policy alignment between the EU and national level as well as a supporting effect from the EU that counteracts lack of capacity (Right upper quadrant). Conversely, Euroscepticism and resistance to Europeanisation is most likely to arise in those situations where there is a low level of alignment coupled with a burden on the limited small state resources (Left lower quadrant). Initiatives that strengthen small state capacity are therefore likely to lead to a propensity to welcome health system Europeanisation.

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Added value of small states to health policy development at EU level

In the current environment further integration of health policy at EU level is not a main

priority for the current European Commission and many Member States are wary of avoiding

intrusion into their health systems from what might be described as the neoliberal agenda, or a

stronger shift toward market forces. In this context, Communitarisation of health policy appears a

most unlikely development. In the EU social model, where health systems are part of the welfare

benefits provided to citizens, the majority of Member States want to continue to maintain a strong

grasp on their national health systems to ensure that they are able to continue to provide the same

type and level of health care coverage as they have done so far. In this context small states, which

depend more on the EU than larger Member States for enhancing their capacity to survive in a

global health care market, may well emerge as drivers of health system Communitarisation

initiatives. The leadership shown in the field of cancer policy by Slovenia which led two major

Joint Actions in recent years provides an interesting example in this regard.(47-48) The fourth part

of the cross-border directive which pertains to cooperation between health systems is also notable

for its potential from a small MS perspective. The development and success of European Reference

Support by EU to compensate for lack of

capacity of MS

Administrative burden on limited resources in MS

Support for health system

Europeanisation diminished by EU

administrative burden

High degree of support for

health system Europeanisation

High level of resistance to

health system Europeanisation

Resistance to health system

Europeanisation diminished by EU

level support

High level of alignment between EU and MS

Low level of alignment between EU and MS

Figure 8.2 - A normative model of health system Europeanisation in a small state Figure 8.2 - A normative model of health system Europeanisation in a small state



Added value of small states to health policy development at EU level In the current environment further integration of health policy at EU level is not a main priority for the current European Commission and many Member States are wary of avoiding intrusion into their health systems from what might be described as the neoliberal agenda, or a stronger shift toward market forces. In this context, Communitarisation of health policy appears a most unlikely development. In the EU social model, where health systems are part of the welfare benefits provided to citizens, the majority of Member States want to continue to maintain a strong grasp on their national health systems to ensure that they are able to continue to provide the same type and level of health care coverage as they have done so far. In this context small states, which depend more on the EU than larger Member States for enhancing their capacity to survive in a global health care market, may well emerge as drivers of health system Communitarisation initiatives. The leadership shown in the field of cancer policy by Slovenia which led two major Joint Actions in recent years provides an interesting example in this regard.(47-48) The fourth part of the cross-border directive which pertains to cooperation between health systems is also notable for its potential from a small MS perspective. The development and success of European Reference Networks for example, will partly depend on the extent to which small states, whose patients are likely to be amongst the greatest beneficiaries, will actively promote and support this initiative.(49) However support from small states alone will not be sufficient to bring about change. Support from the European Commission as well as from the larger Member States would also be necessary.

Whilst at a first glance further Communitarisation of health policy may seem unthinkable, initiatives to benefit small states often bring about an innovative dimension towards the approach of policy problems that eventually offer benefits to larger states too. For example the introduction of an abridged form of medicines registration, which was originally designed to safeguard availability of medicines in small states including Cyprus and Malta (Article 126a also known at the ‘Cyprus Clause’), was found to be useful by larger Member States in registering medicines used to treat rare diseases in small numbers of patients. Furthermore, increasingly registration of such medicines now takes place with the European Medicines Authority through the Centralised Procedure. The evolution of medicines registration is good example of the manner in which health system functions which originally were carried out at Member State level gravitate towards the supranational level.

Small states are often exposed to problems arising from a new policy environment more rapidly and more harshly than other states.(12) This was the case in both economic globalisation as well as the financial crisis. More recently this phenomenon was also experienced in the context of coping with large influxes of migrants. Early recognition

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and investment in policy solutions that provide support for small states during the progression of a novel, challenging situation for health systems will often prove useful for larger states too as the problem grows larger and more intractable. Furthermore since the organisation of health systems within many Member States in the EU occurs at regional level, lessons learned from research and policy implementation in small states may be valuable to address health system governance issues within regions. Equally, the experience from highly decentralized health systems in larger countries could be a useful starting point to examine how the EU can develop a role to help small Member States increase efficiency and resilience of their health systems. Health system functions which are best organised at the federal / national level are likely to be good examples of areas where the EU could take on similar roles at supranational level to aid small and medium sized Member States to improve health system efficiency. Institutional capability and economic sustainability are two key criteria that could be used to assess where locus of authority should best reside (50).

Methodological considerationsThe research process was conducted in a qualitative tradition using an iterative process with continuous assessment and reflection in an effort to ensure the highest possible level of trustworthiness according to the four criteria of credibility, transferability, dependability and confirmability elaborated by Lincoln and Guba as discussed by Shenton and Creswell.(51-52) Nevertheless, several limitations are acknowledged. This section highlights key limitations and steps that were taken to mitigate these limitations.

The dissertation is based upon policy analysis and a single case study. The two approaches have informed each other and flexibility to respond to issues emerging in the data analysis was retained. For example, the selection of policy initiatives for analysis was partly informed through the importance given to these three policy issues by interviewees from the case study. It is possible that selection of different policy issues may have given rise to different conclusions. Given that the policy initiatives analysed were all recently implemented, it is possible that insufficient time has elapsed for the outcomes associated with their implementation to be fully visible. This research, being cross-sectional in nature suffers from the limitations associated with cross-sectional studies, namely that fact that data collection has occurred at a single point in time. Additionally, the phenomena of recall bias or social desirability bias may have compromised some of the findings from the empirical interview study of domestic stakeholders.

Another important issue that merits consideration is the role of the embedded or insider researcher. The researcher considers herself as an embedded or insider researcher both in the domestic as well as the European level since through her practical work experience she has been exposed at both levels. The ethical aspect of being an embedded researcher



was given due importance throughout the research process.(53) Use of reflexivity was undertaken to acknowledge the researcher’s stance and perspective.(54) By bringing this personal experience to the fore it was possible to take additional steps to refrain from influencing the process unduly such as declining to give an own opinion on a matter to an interviewee until after the interview was complete. The sub-studies were co-authored and peer reviewed by persons outside the research setting and context in order to ensure that the insider view which was so necessary to understand the particularities of the case and to guarantee access to the research subjects, was balanced with the outsider view which was objective, impartial and distant. Safeguards were therefore taken to ensure rigour and quality in all of the sub-studies.(55-57)

A principal limitation is the perennial problem of establishing causality in Europeanisation studies.(58) The question which always arises in this type of research is whether Europeanisation is found because of the nature of the study design and whether the effects are due to the EU influence or other confounding factors at domestic and global levels. Two elements which are recommended to avoid the pitfall of overstating the effect of the Europeanisation process and which have been utilised in this research project, are a bottom-up approach and process-tracing.(58) Admittedly it is more difficult to deal with environmental confounding factors including globalisation and the financial crisis, particularly in a situation where European policy is driven by soft as well as hard policy instruments. The approach that was taken was to keep an open mind and to apply counterfactual reasoning in trying to challenge the emerging findings.

A final issue relates to the main limitation associated with single case studies namely, the transferability of the research findings. The unique small island context and historical development of the Maltese health system is no doubt an important factor that influences and permeates the case study. Nevertheless, although each case may be unique, it is also an example within a broader group.(51) An attempt to facilitate transferability has been made by providing detailed information on the context of the case study and the methods employed. It is hoped that these steps will facilitate judicious application of the findings as well as the pursuit of comparable research on health system Europeanisation in other settings.

Implications for research and policy Future research should seek to examine whether the favourable normative assessment of the EU influence on a domestic health system is something unique to the Maltese setting, a feature typical of small states or a feature which is common to several Member States. Factors associated with support for health system Europeanisation identified in this thesis could form a basis upon which to further develop EU health policy and to explore the concept of health policy Communitarisation.

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Small states may have a greater tendency to seek Communitarisation of health policy than larger states. Member States that have invested significantly in the development of their own national institutions to carry out health system functions may resist transfer of authority to supranational institutions. Policies with sufficient inherent flexibility to allow Member States to cooperate to different extents depending on their needs and preferences therefore appear to the best solution.

It is recommended that EU policy makers seek to understand which are the Communitarisation policies that MS appear to resist and why. Resistance arising from a clash of norms and values between what is being promoted at EU level and policy objectives within the MS can only be addressed through paradigm shifts. Though this may be a challenging undertaking, successful further development of health policy at European level necessitates value alignment amongst key actors at the EU institutional and MS levels. Conversely, resistance that arises because of disproportionate administrative burden can be more readily and easily addressed through the pursuit of appropriate policies that are sensitive to health system specificities including those related to small size. Furthermore initiatives targeting lack of capacity and small market size can actually convert resistance to EU intrusion into support for EU level action.

CONCLUSION

This thesis has shown that EU policy in the area of health remains weak and fragmented. There is the potential and necessity for the EU to take on a larger role on the global health policy stage. Small Member States may be active supporters for such a role to be developed.

For health systems in the EU to become more effective, efficient and resilient, the EU must do more than it is currently doing in the area of health. If the EU wishes to be relevant to European citizens, it cannot afford to push health policy and health systems aside when these are primary concerns for the vast majority of EU citizens. EU health policy appears to be evolving more by chance than by actual design. The financial and economic crisis has indirectly presented an opportunity for further integration of health policy and health systems at European level but this drive exhibits the features of the EU’s constitutional asymmetry with an overriding concern for fiscal and economic objectives. Such development is often incongruent with Member State values and is therefore resisted. However the traditional narrative that Member States resist any form of European action in the area of health services may not always be true. This may be due to changing environmental circumstances in the global health sector or specific experiences in particular Member States. This thesis has demonstrated how domestic stakeholders actually seek to instrumentalise the EU to achieve policy objectives within



their health systems. Beyond the impact associated with the adoption of the internal market Acquis during the accession process, there is little evidence to show that the EU impacts on health services on a day to day basis. From a small state perspective, although the EU can be a welcome external driver to overcome reform inertia, it still needs to do far more to fulfil the role of shelter provider and support mechanism for health systems. In this respect, small state stakeholders may play an important role in defining the scope for Communitarisation of health policy through support for initiatives that can enlarge small state health system capacity. Although the findings from this dissertation require confirmation through replication in other small states in order to provide a solid basis for action at EU level, this research, having been the first of its kind to focus attention on the influence of EU health policy development on health systems in small states, will hopefully serve to stimulate interest in this innovative area of research.

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Valorisation

Lists of Tables, Figures and Boxes

List of Abbreviations

Summary, Samenvatting

Acknowledgements

Curriculum Vitae

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Valorisation | 185

VALORISATION OF THE RESEARCH

This is the first study that has explored health systems through a small state perspective. Furthermore, it has evaluated the role played by the European Union in shaping a small state health system. The research results indicate that European Union health policy, when examined through the lens of a small health system, may be perceived in a different manner to that traditionally described in the literature where Member States resist European Union intrusion in their health systems. This study therefore challenges the dominant paradigm that European Union Member States are somewhat reluctant to pursue policies and initiatives in the area of health systems within the European Union framework. These findings come at an important moment. European health policy is at a cross roads and risks being marginalised in view of the dominance of economic and security concerns on the European agenda. This dissertation, by providing evidence of the value European initiatives can bestow for health systems in small states, proposes new visions through which the future for European action on health systems can be considered. It offers important insights into what small states perceive as being supportive or unduly burdensome, thereby providing European Union policy makers with valuable information for future legislative and policy proposals. As European governments seek solutions to improve the efficiency and sustainability of publicly financed health systems it is useful to challenge the hitherto accepted ‘peripheral’ role for the European Union in shaping and supporting health systems. This challenge may be considered as an example of ‘disruptive innovation’ at macro level required to inject new life into the policy process with respect to health systems at European level.

Whilst the results from this dissertation are primarily of interest to health policy makers in small states, they may also be of interest to health policy makers at regional level in larger states with highly decentralised health systems. The findings will also be of interest to the European Commission, particularly DG SANTE and DG ECFIN since both these DGs are presently involved in finding ways of supporting national health systems to achieve better efficiency whilst safeguarding access and ensuring sustainable models of health financing for future generations. The dissertation is also of interest to the WHO Regional Office for Europe as WHO has recently embarked on a series of initiative to support small countries in Europe.

Through the work carried out in this dissertation, the topic of health systems in small states has been positioned on the European public health agenda. The author of this dissertation has designed and coordinated the successful implementation of a series of workshops European Public Health conferences. The first workshop which was organised in 2007 discussed the implications of the cross-border care directive for small states and remote communities.(1) In 2012 following the adoption of the cross-border

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directive a workshop was organised to analyse the possible implications for small states.(2) In 2014 the scope of the discussion was widened and policy challenges more generally for health systems in small states were presented and discussed.(3-4) The 2014 workshop was the first activity in the area of health systems to be organised by the Islands and Small States Institute at the University of Malta in partnership with the WHO European Office for Investment for Health and Development. It followed the launch of the WHO ‘Small Countries Initiative’ and sought to build on the issues identified in the report from the First High Level Meeting of Small Countries held in San Marino in July 2014.(5) The Small Countries Initiative brings together Andorra, Cyprus, Iceland, Luxembourg, Malta, Monaco, Montenegro and San Marino. These are all counties with a population under one million. In 2015 a workshop was organised by the Islands and Small States Institute at the University of Malta. This workshop was also organised in partnership with the WHO European Office for Investment for Health and Development and focussed on the specificities of health information systems in small states.(6-7) It provided an important basis for the WHO Small Countries Health Information Network (SCHIN) which sprang from the Small Countries Initiative and which held its first meeting in Malta, under the chairmanship of the Maltese delegation in March 2016. This network is supported by the WHO Regional Office for European Division of Information, Evidence, Research and Innovation and a publication for Public Health Panorama is currently being prepared to report upon the health information specificities identified by small country focal points during the first network meeting.

As illustrated above, the WHO Regional Office for Europe has shown significant interest in the work that has been carried out through this dissertation since this is of relevance to the new initiatives to support small countries in the European region. As a direct consequence of the work on this dissertation, a multi-disciplinary Health Research Group has been established at the University of Malta under the auspices of the Islands and Small States Institute. A presentation on Leadership and Governance in Small State Health Systems was delivered during the Second High Level meeting of the Small Countries Network in Andorra in 2015 and this presentation was partly based on findings that emerged from the research carried out to prepare this dissertation. Furthermore the Islands and Small States Institute of the University of Malta has been designated a candidate WHO Collaborating Centre on Health Systems and Policies in Small States and is expected to apply and receive its full designation as a WHO Collaborating Centre in 2017.(8) This will provide a platform for the research on health systems in small states to be continued. It will also serve as an opportunity to consider small state issues outside Europe since the WHO Collaboration Centres form a global resource network.

The research findings from this dissertation are also influencing the policy agenda at national and EU levels. The author of this dissertation has been invited to form part of


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the Core Coordinating Team within the Ministry for Health tasked to advise upon and coordinate the health sector related work for the Maltese Presidency of the Council of the European Union due in the first half of 2017. In this context, the work in this dissertation has been instrumental in informing the approach towards the planned thematic priority of Structured Cooperation between health systems in the European Union. The underlying viewpoint is that as globalisation and emerging trends in medicine threaten to destabilise the current models for financing and organising care and delivery of health services in Europe, there is an urgent need for Europe’s Member States to seek innovative methods of structured and sustained cooperation. Such cooperation may be of added value particularly to ensure affordable access to high quality highly specialised and innovative technologies and services for all citizens throughout the European Union, irrespective where they reside in Europe. These topics are expected to be discussed in a thematic workshop on Structured Cooperation between EU health systems under the aegis of the Maltese Presidency of the Council of the European Union.

Last but not least important, the research carried out in this dissertation has informed the preparation for a European project funded under the ERASMUS + call for proposals for Jean Monnet Networks. The proposal was successful and this has resulted in funding for a Jean Monnet Network on European Integration Small States and Health (565538-EPP-1-2015-1-NL- EPPJMO-NETWORK) between 2015 and 2018. Through this network coordinated by the Department of International Health at Maastricht University, Malta, Estonia, Iceland and Slovenia shall be used to research the potential role of the European Union in addressing health system challenges in small states. The research seeks to test the transferability of the findings from this dissertation in the Maltese context in other small EU Member States. Human resources, cancer, rare diseases and procurement of innovative medicines will be discussed in a series of national workshops with researchers and health policy stakeholders. At the end of the project, a curriculum for health systems within the area of European studies will also be developed in order to continue to develop the research and policy capacity in this newly developing area of study. The findings will also be presented to key stakeholders through high profile events such as the European Public Health Conference, European Health Forum Gastein and the WHO High Level Meeting of Small Countries.

The above examples illustrate how the scholarly work from this dissertation is already finding useful applications in health policy development at national and international levels. It is anticipated that through the above-mentioned initiatives, further academic publications and policy publications will result. This dissertation has explored the influence of the European Union on health systems in small states. It is hoped that the research findings will in turn influence future policy developments at European level in such a way that health systems in small states may benefit from this research.

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REFERENCES

(1) The effects of European policy developments on health services for small Member States and remote communities. Eur J Public Health; 2007, 17(suppl 3).

(2) Can small countries keep up in the cross border game? Eur J Public Health; 2012, 22(suppl 2): p.65-66.

(3) Challenges and policy concerns for health systems in small European states. Eur J Public Health; 2014, Oct 1; 24(suppl 2): cku163.097.

(4) Malta and Cyprus: What can they learn from each other and what lessons emerge for health system reformers? Eur J Public Health; 2014, Oct 1; 24(suppl 2): cku163.098.

(5) World Health Organisation Regional Office for Europe. Meeting report of the First High-level Meeting of Small Countries: Implementing the Health 2020 vision in countries with small populations San Marino, 3–4 July 2014. 2014.

(6) Azzopardi-Muscat N., Thyssen S.G., Stoner D., Calleja N. Factors affecting data availability in the European region. Does population size matter? Eur J Public Health; 2015, October 1; (suppl 3): ckv173.029.

(7) Thyssen S.G., Gauci D., Azzopardi-Muscat N. A qualitative study of the experiences of health information practitioners in a small European country. Eur J Public Health; 2015, October 1; 25(suppl 3): ckv173.032.

(8) University of Malta. Health Research Group: Islands and Small States Institute. 2015; Available at: https://www.um.edu.mt/islands/health_research_group. Accessed 25 April 2016, 2016.


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LISTS OF TABLES, FIGURES AND BOXES

List of TablesTable 2.1 - Characteristics of small states included in this literature review 32Table 3.1 - Trends in population/demographic indicators, selected years 54Table 3.2 - Macroeconomic indictors, selected years 56Table 3.3 - Mortality and health indicators, selected years 58Table 3.4 - Standardised mortality rates/100,000 main causes of deat, selected years 59Table 3.5 - Health indicators during the period 1984-2010 61Table 3.6 - Maternal, child and adolescent health indicators, selected years 62Table 3.7 - Vaccine uptake in Malta 2008-2011 62Table 4.1 - Professional roles of participants interviewed 86Table 4.2 - Health system transformation and adaptation (Malta 2004-2014) 93Table 4.3 - Inertia and resistance to health system reform (Malta 2004-2014) 94Table 5.1 - List of Interviewees by primary role 114Table 6.1 - List of countries having signed the Joint Procurement Agreement 131Table 7.1 - Member States issued with health system recommendations through 153 CSRs Table 7.2 - Framing of CSRs 154Table 7.3 - Classification of CSR content by policy objective and health system 154 domain* Table 7.4 - Results from binary logistic regression with presence of CSR as 155 outcome variable Table 7.5 - Association between trends in public health expenditure growth 156

List of FiguresFigure 1.1 - Health System Conceptual Framework (69) 15Figure 1.2 - Conceptual Framework - Europeanisation of a small state health system 21Figure 2.1 - Flow chart of the selection process 33Figure 2.2 - Literature Map – Health Systems in Small Research in European States 35Figure 3.1 - Map of Malta 54Figure 3.2 - Percentage of unmet need for medical examination due to financial reasons 74Figure 4.1 - The process of Europeanisation in the Maltese health system 88Figure 5.1 - Impact of the patients’ rights and cross border care directive on the 115 Maltese health system Figure 8.1 - Summary of main findings from dissertation 166Figure 8.2 - A normative model of health system Europeanisation in a small state 174

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List of BoxesBox 3.1 - Major reforms and strategies since 2007 64Box 5.1 - Key facts about the Maltese health care system 112Box 7.1 - Description of the ‘European Semester’ 148


List of Abbreviations | 191

LIST OF ABBREVIATIONS

COREQ Consolidated Criteria for Reporting Qualitative ResearchCSR Country Specific RecommendationDG ECFIN Directorate General for Economy and FinanceEAP Economic Adjustment ProgrammeECDC European Centre for Disease ControlECJ European Court of JusticeESPAD European School Survey Project on Alcohol and other DrugsEU European UnionGCC Gulf Cooperation CouncilGDP Gross Domestic ProductHPSR Health Policy and Systems ResearchHTA Health Technology AssessmentIT Information TechnologyJPA Joint Procurement AgreementMMR Mumps Measles RubellaMoU Memorandum of UnderstandingMRI Magnetic Resonance ImagingMS Member StateNHSS National Health Systems StrategyNOIS National Obstetrics Information SystemOECD Organisation for Economic Cooperation and DevelopmentOECS Organisation of Eastern Caribbean StatesPAHO Pan American Health OrganisationPATH Performance Analysis Tool for quality improvement in HospitalsPOYC Pharmacy of Your ChoicePPS Pharmaceutical Procurement SystemSILC Survey on Income and Living ConditionsTFEU Treaty on the Functioning of the European UnionUNFPA United Nations Fund for Procurement ActivitesUREC University Research Ethics CommitteeWHO World Health Organisation

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Summary | 193

SUMMARY

Europe has come under pressure from a series of unprecedented challenges namely; the financial crisis, migration and security issues. These challenges are taking up significant space on the European policy agenda. As a result public health paradoxically risks being sidelined, in spite of the clear effect that these challenges are having on health systems. Descriptions of the impact of the European Union on health systems have varied from a ‘least likely’ case of Europeanisation to examples where internal market and fiscal and economic policies of the European Union have had far-reaching consequences. The future of European health policy is at a cross roads. Arguments for less Europeanisation of health systems currently dominate the discourse at national and European levels while at the same time the European Union is called to respond actively in crises situations such as the recent Ebola outbreak. In these circumstances, an evaluation of the health system Europeanisation experience within a Member State can provide important evidence to inform future considerations on a health strategy for the European Union.

The central aim of this dissertation was to explore the influence of the European Union on a Member State health system from a small state perspective. In order to address this aim, this research project travelled through the disciplines of health systems research, European studies and small state studies. The latter can provide a valuable perspective to the study of European health policy. Research on small states offers a possibility to reconsider the theoretical and practical implications of complex European integration processes by introducing fresh approaches and paradigms to tough policy dilemmas. The theory of Europeanisation was used to construct a conceptual framework for the dissertation. The relationship between the European Union and the Member State health system is viewed as a two-way process in which domestic systems come under pressure to adapt to policy emanating from the European Union whilst simultaneously seeking to influence the trajectory of future policy development. A qualitative approach underpins the methods utilised in this dissertation where the main research interest was the analysis of complex policy processes and interactions between actors and institutions, at multiple levels.

The dissertation is composed of three parts. A narrative literature review was carried out to synthesise the evidence on health system challenges and reforms in small EU Member States. From this review, a literature map was produced which established that there is a gap in the knowledge on the influence of the EU on small state health systems. The second component of the dissertation comprises the case study of the Europeanisation of the Maltese health system. This was conducted through a desk-top health system review and an empirical study of domestic stakeholders. Through this empirical study, the general stakeholder experience regarding health system Europeanisation and their

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attitudes towards the role of the EU were elicited. Additionally, an in-depth analysis of the implementation of the patients’ rights and cross-border care directive was carried out. This provided a specific recent example of the impact of EU legislation on a small state health system. The third component of the dissertation focussed on evaluation of ongoing policy developments at EU level. The Joint Procurement Agreement for cross-border health threats and the European Semester country specific recommendations for health systems were assessed for evidence of their impact on domestic health systems.

It was revealed that small state health systems experience certain common challenges as a result of their lack of human and resource capacity as well as their small market size. This lack of capacity impinges on aspects of health system governance and constrains their ability to achieve self-sufficiency in the provision of highly specialised health services. Lack of capacity also impacts negatively upon implementation of health system reform and the EU can often acts as an external trigger for health system reform.

The Maltese case study illustrated how the EU accession process is a powerful stimulus for health system reform, driven through the mechanism of regulatory compliance. Sectors over which the EU has a long-standing experience of competence and regulation, such as medicines and mutual recognition of professional qualifications, underwent significant transformation. Over a decade of EU membership, the public health workforce experienced the benefits of networking and capacity building. The organisation, financing and delivery of health services were however mainly unaffected.

This dissertation presented a normative model for health system Europeanisation in a small state. Contrary to the traditional narrative that stakeholders resist an active EU role in health systems, it was found that overall, domestic health system stakeholders had a positive experience of EU membership and actively sought to use the opportunity to implement desired norms. Health system Europeanisation was viewed most positively where there was a high level of policy alignment between the EU and national policy objectives, coupled with a supportive effect from the EU to counteract lack of capacity. Conversely, Euroscepticism was associated with situations where there was a great burden on the limited small state resources and a lack of alignment of values between domestic and EU objectives. In spite of their limited resources, stakeholders also vigorously intervened to shape the course of EU policy development in the case of the cross-border directive. It was confirmed that stakeholders in Malta generally exhibit a considerable level of support for EU intervention in health policy and health system stewardship. Their desire for the EU to assume a greater role in health policy stems primarily from the need to enlarge the capacity of a small state to tackle serious public health problems and also to assist domestic policy-makers to overcome local inertia and resistance to health system reform. The EU was perceived as having the potential to support small state health systems through the elaboration of appropriate policies and


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programmes. However disappointment arose from the fact that this role is not being fulfilled sufficiently effectively to date. The caveat here is that a one size fits all approach was found to be problematic and assurance of a better understanding of the specificities of small states by EU policy-makers was deemed necessary by stakeholders. Whilst due care must be taken when considering the transferability of these findings to other contexts, this dissertation has revealed important and innovative evidence on health system stakeholder attitudes towards the role of the EU in health systems.

Finally this dissertation established that the Communitarisation of health policy in the EU is an ongoing endeavour. The drive for health policy development appears to be fashioned by chance and crisis. The most visible ongoing EU policy developments are strongly linked to the objectives of improving efficiency or economic governance. In contrast, initiatives to address public health needs appear to be weaker, providing an example of the manner in which EU constitutional asymmetry is affecting health systems.

This dissertation concluded that in the current environment, further integration of health policy at EU level appears to be an unlikely development. Small states depend more on the EU than larger Member States for enhancing their capacity to survive in a global health care market. They are often exposed to problems arising from a new policy environment more rapidly and more harshly than other states. In this context, small states may well emerge as drivers of future health system Communitarisation. Early recognition and investment in EU policy solutions to benefit small states can introduce innovative concepts that can eventually offer benefits to larger states, particularly those with decentralised health systems. This concept has important implications as European policy-makers grapple to strengthen health system resilience in the face of extraordinary challenges.

This research project has conducted a comprehensive analysis of EU policy influence on health systems. By seeking to dispel myths about the role of the EU in health systems, it aims to open up new channels for research and policy initiatives at a time when health systems need a strong response from a European Union that is sensitive to their needs and aspirations.

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Samenvatting | 197

SAMENVATTING

Europa is onder druk gezet door een aantal ongekende uitdagingen, te weten: de financiële crisis, migratie en kwesties met betrekking tot veiligheid. Deze uitdagingen vergen enorm veel tijd van de Europese beleidsagenda. Resultaat daarvan is, paradoxaal genoeg en ondanks het duidelijk effect dat deze uitdagingen kennen op het gebied van gezondheidssystemen, dat volksgezondheid een ondergeschoven kindje is. Beschrijvingen van de impact van de Europese Unie op gezondheidssystemen, varieerden van ‘minst waarschijnlijk’ geval van europeanisatie tot voorbeelden waarin de euromarkt en fiscale alsook economische gedragslijnen van de Europese Unie verregaande consequenties hebben gehad. De toekomst van het Europese gezondheidsbeleid staat op een kruispunt. De dialoog op nationaal en Europees niveau wordt momenteel overheerst door de argumenten voor minder europeanisatie van de gezondheidssystemen terwijl tegelijkertijd een beroep op de Europese Unie wordt gedaan om actief te reageren in crisissituaties zoals de recente Ebola-uitbraak. Onder de gegeven omstandigheden kan een evaluatie van de europeanisatie-ervaringen inzake gezondheidssystemen binnen een lidstaat, belangrijke kennis leveren voor toekomstige overwegingen met betrekking tot een gezondheidsstrategie voor de Europese Unie.

Het centrale doel van deze dissertatie was om de invloed van de Europese Unie op gezondheidssystemen van lidstaten, vanuit het perspectief van een kleine staat, degelijk te onderzoeken. Om dit aan te pakken heeft dit onderzoeksproject de disciplines van gezondheidszorgonderzoek, Europese studies en kleine statenstudies doorlopen. Dit kan een waardevol perspectief toevoegen aan de studie over Europees gezondheidsbeleid. Het verrichten van wetenschappelijk onderzoek naar kleine staten biedt de mogelijkheid de theoretische en praktische implicaties van complexe Europese integratieprocessen te heroverwegen door een nieuwe benadering en paradigma’s van moeilijke beleidsdilemma’s.

De theorie van europeanisatie is gebruikt om een conceptueel raamwerk te maken voor deze dissertatie. De relatie tussen de Europese Unie en het Member state health system wordt gezien als een tweezijdig proces waarin systemen binnen het eigen land onder druk komen te staan om zich aan te passen aan het beleid dat uitgestraald wordt door de Europese Unie terwijl er tegelijkertijd naar wordt gezocht het traject van toekomstige beleidsontwikkelingen te beïnvloeden. Een kwalitatieve benadering ligt ten grondslag aan de methodes die gebruikt zijn in deze dissertatie waarin de analyse van complexe beleidsprocessen en interacties tussen deelnemers en instituten, op diverse niveaus, de hoofdzaak was.

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Deze dissertatie bestaat uit drie delen.Een narratieve literatuurstudie werd uitgevoerd om het bewijs van problemen op het vlak van hervormingen van gezondheidszorgsystemen in de kleine EU-lidstaten te synthetiseren. In dit onderzoek werd voorlichtingsmateriaal in kaart gebracht. Daarin werd vastgesteld dat er een kloof bestaat in de kennis over de invloed van de EU op de gezondheidszorg in kleine staten.

De tweede component van het proefschrift bestaat uit de casestudy van de Europeanisering van het Maltese stelsel van gezondheidszorg. Dit werd uitgevoerd door middel van een desk-top gezondheidszorgbeoordeling en een empirische studie van nationale stakeholders.

Door middel van deze empirische studie, werden de ervaringen van algemene belanghebbenden met betrekking tot gezondheidszorg-europeanisering en hun houding ten opzichte van de rol van de EU, aan het licht gebracht. Daarnaast is een diepgaande analyse van de implementatie van de patiëntenrechten en richtlijnen, inzake de grensoverschrijdende zorg, uitgevoerd. Dit leverde een specifiek recent voorbeeld op van het effect van de EU-wetgeving op het gezondheidssysteem van een kleine staat. De derde component van het proefschrift richt zich op de evaluatie van lopende beleidsontwikkelingen op EU-niveau. De Joint Procurement Agreement inzake grensoverschrijdende gezondheidsbedreigingen en de European Semester landenspecifieke aanbevelingen voor de gezondheidszorg werden beoordeeld op het bewijs van hun impact op de binnenlandse gezondheidszorg.

Gebleken is dat gezondheidssystemen van een kleine staat bepaalde gemeenschappelijke uitdagingen hebben als gevolg van hun gebrek aan personeel en middelen alsook van hun kleine omvang van de markt. Dit gebrek aan capaciteit doet afbreuk aan aspecten van gezondheidszorgbestuur en de beperking in hun vermogen om zelfvoorzienend te zijn in het verstrekken van zeer gespecialiseerde gezondheidszorg. Gebrek aan capaciteit heeft ook een negatieve invloed op de implementatie van de gezondheidszorghervormingen en de EU kan vaak fungeren als een externe trigger voor de veranderingen in de gezondheidszorg.

De Maltese casestudy illustreerde dat - gedreven door middel van het mechanisme van de naleving van de regelgeving - het EU-toetredingsproces een krachtige stimulans is voor hervorming van de gezondheidszorg. Sectoren van de EU waarin men beschikt over een jarenlange ervaring van competentie en regelgeving, zoals medicijnen en de wederzijdse erkenning van beroepskwalificaties, ondergingen een aanzienlijke transformatie. In meer dan een decennium EU-lidmaatschap, hebben de medewerkers in de publieke gezondheidszorg de voordelen ervaren van netwerken en capaciteitsversterking.


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De organisatie, de financiering en de levering van de gezondheidszorg bleven echter hetzelfde.

Dit proefschrift presenteerde een normatief model voor de Europeanisering van de gezondheidszorg in een kleine staat. In tegenstelling tot het traditionele gegeven dat betrokkenen een actieve rol van de EU in de gezondheidszorgsystemen tegenhouden, werd, over het algemeen, vastgesteld dat de binnenlandse stakeholders een positieve ervaring hadden met het EU-lidmaatschap en dat ze actief getracht hebben om van de gelegenheid gebruik te maken om de gewenste normen te implementeren. Europeanisering van het gezondheidssysteem werd het meest positief gezien daar waar er een hoog niveau was van beleidsafstemming tussen de EU en de nationale beleidsdoelstellingen, gekoppeld aan een ondersteunende werking van de EU om een gebrek aan capaciteit tegen te gaan.

Omgekeerd, werd euroscepticisme geassocieerd met situaties alwaar een grote last was van de beperkte middelen van een kleine staat en een gebrek aan afstemming van de waarden tussen nationale en EU-doelstellingen. Ondanks hun beperkte middelen, hebben belanghebbenden ook krachtig ingegrepen om de loop van de ontwikkeling van het EU-beleid vorm te geven met betrekking tot de grensoverschrijdende richtlijn. Bevestigd werd dat de belanghebbenden in Malta over het algemeen een aanzienlijke mate van steun voor EU-interventie in het gezondheidsbeleid en het rentmeesterschap van de gezondheidszorg laten zien. Hun verlangen om de EU een grotere rol in het gezondheidsbeleid te laten aannemen is voornamelijk het gevolg van de noodzaak om de capaciteit van een klein land te vergroten en daarmee ernstige problemen voor de volksgezondheid aan te kunnen pakken alsmede de binnenlandse beleidsmakers te helpen om de lokale inertie en weerstand tegen hervorming van het gezondheidszorgsysteem te overwinnen. De EU werd gezien als het hebben van de mogelijkheid gezondheidszorg in kleine staten te ondersteunen door middel van de uitwerking van een passend beleid en programma’s. Er is echter teleurstelling gezien het feit dat deze rol, tot nu toe, niet of niet voldoende effectief ten uitvoer is gebracht. Hierbij is het voorbehoud dat een one size fits all benadering problematisch bleek en de zekerheid om een beter begrip te hebben van de specifieke kenmerken van kleine staten door EU-beleidsmakers werd door de belanghebbenden noodzakelijk geacht.

Hoewel zorgvuldigheid in acht moet worden genomen bij het overwegen van de overdraagbaarheid van deze bevindingen naar andere contexten, heeft dit proefschrift belangrijk en vernieuwend bewijsmateriaal aangetoond voor wat betreft de houding van stakeholders in de gezondheidszorg ten opzichte van de rol van de EU in gezondheidszorg.

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Ten slotte heeft dit proefschrift vastgesteld dat de communautarisering van het gezondheidsbeleid in de EU een voortdurende inspanning is. De drijfkracht voor de ontwikkeling op het vlak van het gezondheidsbeleid lijkt te worden gevormd door toeval en crisis. De meest opmerkelijke ontwikkelingen in het EU-beleid zijn sterk gekoppeld aan de doelstellingen tot verbeteren van de efficiëntie of economische governance. In tegenstelling tot het vorengestelde, lijken initiatieven om volksgezondheidsbehoeften aan te pakken zwakker, hetgeen een voorbeeld levert van de wijze waarop de constitutionele asymmetrie van de EU van invloed is op gezondheidssystemen.

In dit proefschrift wordt geconcludeerd dat in het huidige klimaat, verdere integratie van het gezondheidsbeleid op EU-niveau een onwaarschijnlijke ontwikkeling lijkt. Kleine landen zijn meer afhankelijk van de EU dan de grotere lidstaten voor wat betreft het verbeteren van hun vermogen om te overleven in een mondiale markt voor gezondheidszorg. Zij worden vaak sneller en harder blootgesteld aan problemen, voortkomend uit een nieuwe beleidsomgeving, dan andere landen. In deze context kunnen kleine staten een stuwende kracht gaan vormen voor het toekomstig stelsel van gezondheidszorg- communautarisering. Vroegtijdige herkenning en investeringen in oplossingen voor het EU-beleid waar kleine staten van profiteren, kunnen innovatieve concepten introduceren die uiteindelijk voordelen kunnen bieden aan de grotere landen, met name die met gedecentraliseerde gezondheidszorg. Dit concept heeft belangrijke implicaties aangezien de Europese beleidsmakers worstelen om gezondheidssystemen veerkrachtiger te maken wanneer ze geconfronteerd worden met buitengewone uitdagingen.

Dit onderzoeksproject heeft een uitgebreide analyse van de invloed van het EU-beleid op gezondheidszorg uitgevoerd. Door het streven om mythen over de rol van de EU in de gezondheidszorg te ontkrachten, heeft het als doel om nieuwe kanalen toegankelijk te maken voor onderzoek en beleidsinitiatieven wanneer zorgstelsels een sterke reactie van een Europese Unie, die nauw luistert naar hun behoeften en ambities, nodig hebben.


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ACKNOWLEDGEMENTS

I believe that the acknowledgements section is always one of the hardest pieces to write. This is especially true when one is as privileged as I have been to have had the generous support and encouragement of scores of individuals who have all in some way or another inspired, shaped or practically supported my PhD trajectory. Whenever I read a book or a dissertation, the first page I turn to is the acknowledgements section since I am always eager to learn more about the person whose work I am reading. It is perhaps for this reason that I attribute so much importance to the acknowledgements. At the outset I must apologise to anyone I may have failed to include. When the list of persons to thank is a very long one, experience has taught me that somebody will always be overlooked. For those persons whose name does not appear here but who have somehow contributed to the success of this dissertation, this PhD is yours too!

I start by expressing my deepest gratitude to my promoter Prof Helmut Brand. Helmut has been extraordinarily patient and generous. He has pushed me to see the bigger picture, to look beyond obtaining the PhD. We have had many fruitful discussions which have shaped this work. Above all, Helmut is a wise gentleman and I am grateful for his guidance on the wider aspects of transiting from ‘civil servant’ to ‘academic’. Dear Helmut, from you I have learnt that being a supervisor is much more than discussing study design and reading drafts. It is about alternately challenging and supporting your students to achieve their goals. I hope to become a better supervisor myself through this experience.

I also sincerely thank my co-promoter Prof Roderick Pace. When Roderick accepted to be my co-promoter, he took on a medical doctor with no qualifications in international relations, other than my practical exposure in the field. In his gentle and unassuming manner, he guided and corrected, steering me towards a better understanding of the field of Europeanisation. He shared my enthusiasm for this research project and was a constant source of encouragement and inspiration.

I would like to thank the members of the assessment committee for taking the time to read through this dissertation and for their positive evaluation.

My gratitude is extended to the members of the International Health Department at Maastricht University. You always made time for me in your hectic schedules during my short visits to Maastricht. The conversations around different aspects of my PhD were extremely valuable. Your insights and practical experiences made my visits to Maastricht all the more worthwhile. A special word of thanks goes to Anita Creusen the departmental secretary who was my practical anchor for all aspects pertaining to logistics and organisation as well as for the summary in Dutch.

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202 | Acknowledgements

I would like to thank all my colleagues in the European Public Health Association Executive Council. Your esteemed advice and enthusiastic encouragement have been of immense value.

Turning now to friends and colleagues in Malta, I would like to warmly thank Sandra and Kenneth, colleagues from the Department of Health Services Management at the University of Malta. You were always available to critically discuss aspects of my PhD and you actively encouraged me to keep going, particularly in difficult moments when it seemed like it was all too much to handle. I would also like to thank Neville, the Director and all my colleagues at the Directorate for Health Information and Research. Thank you for listening patiently as I navigated through the highs and lows of the PhD process and optimistically cheering me on towards the finish line offering valuable advice on various topics including statistical methods. I thank Sascha the public health trainee who helped me to format and edit the manuscript in record time before submission to the Assessment Committee.

A special word of thanks goes to those colleagues who feature as co-authors of papers included in this dissertation. They enthusiastically carried out the respective tasks I assigned to them, in order to meet my self-imposed quality assurance criterion of having articles, documents and interviews that I reviewed, scored or coded, independently assessed by at least one other person. They made time to participate in consensus meetings. Most importantly, they were excellent at finding positive elements in comments I received from journal reviewers which often left me feeling rather distressed. I also thank the journal reviewers and editors since the quality of the papers undoubtedly improved as a result of the publication peer-review processes.

I am deeply obliged to the domestic stakeholders who agreed to be interviewed about Malta’s health system Europeanisation process, even though the absolute majority had never previously heard of the term ‘Europeanisation’. They shared their knowledge and experiences in a frank, forthright and passionate manner. I trust that through careful and painstaking analysis of the interview transcripts, I have portrayed their story and their aspirations in an accurate and meaningful manner remain true to their ‘voices’.

I am grateful for the financial support provided through the Malta Government Scholarship Scheme. I would also like to thank the Ministry for Health for the statutory 30 days annual paid study leave I have utilised for the past three years to enable me to work on my PhD, visit my supervisor at Maastricht University and participate in conferences.

Having a full time job with Government, a resident academic position and a voluntary role in a European association, whilst simultaneously carrying out a PhD, does require an inordinate amount of juggling, multitasking and an unlimited supply of energy. However it also means that I could draw upon the priceless support of a vast network


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of extremely talented individuals. I consider myself fortunate to have such a network. This PhD however would never have happened without the love and support of

my family. I am deeply indebted to my parents Marie and Godfrey. They believed in me and provided infinite emotional and practical support during this PhD journey. Of course, one could quip that it was the least they could do having been the persons to spur me to embark on this PhD. It had always been a dream of mine to eventually read for a PhD. This dream kept being relegated repeatedly to the back burner of my life. They pushed me to enrol at the time when I thought I had reached the pinnacle of my career in my position as Director General in the Ministry of Health. Being older, wiser and more experienced than myself, they foresaw what the future would bring. Little did I realise back in 2010 how important this PhD was going to be. Besides the opportunities it brought for my professional development, working on the PhD turned out to be my professional lifeline after the challenging career transition I experienced in 2013.

I cannot find the right words to thank my husband Conrad. For Conrad who is a physician, research takes on the form of head-to-head, double-blind, multi-centre, randomised clinical trials with the odd meta-analysis interspersed. To him, my research seemed somewhat esoteric and he constantly expressed his hope that I knew what I was doing. Conrad has stood steadfastly by my side for the past twenty years as I have taken on countless professional challenges. At times, this PhD seemed to be a bridge too far, a burden too heavy for our family to bear. Now that it’s accomplished, dear Conrad, you too can heave a sigh of relief……until I embark upon another adventure!

Finally, I must beg my three children Aidan, Sereena and Nathan for forgiveness. For all the weekends I spent indoors locked up in my study, for all the travel associated with my PhD, for the important events I missed, for all the times that this research project has taken me away from you both physically and emotionally, Sorry.

Aidan, I sincerely wish that should you ever decide to undertake a PhD you will be able to honour your pledge to “get it over and done with before having children”.

Sereena, you have taken a great interest in my research and you think you might like to become a researcher. What remains now is to identify the field of study that fires your passion.

Nathan, it has been hard for you to understand how mummy has been working on this PhD since even before you were born. I hope I haven’t put you off research. There are persons who finalise a PhD over a shorter time-frame.

My dear children, perhaps someday you too will experience the personal growth and emotional roller-coaster that comes with the process of undertaking a PhD. Aidan, Sereena and Nathan, this dissertation is dedicated to you.

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CURRICULUM VITAE

Natasha Azzopardi Muscat was born on 6th August 1973 in Attard, Malta where she lives with her husband and three children.

Educational experienceNatasha attended school at the Convent of the Sacred Heart. She also studied classical ballet and piano. She read medicine at the University of Malta and qualified as a medical doctor in 1995. She continued her studies in public health and obtained her Master degree from the University of Malta in 1997. Her dissertation, Trends in Cardiac Surgery in the Maltese Population, tackled the transition process from sending patients overseas for cardiac surgery to the implementation of cardiac services in Malta. She was awarded a Chevening Scholarship by the British Council and left Malta to study Health Services Management at the London School of Hygiene and Tropical Medicine and the London School of Economics and Political Science, from where she graduated with Distinction in 1998. In 2003, she sat for and successfully obtained the Membership of the Faculty of Public Health of the United Kingdom. She was elected as a Fellow of the Faculty of Public Health in 2006. In 2010 she commenced her PhD trajectory as an external PhD student with the Department of International Health at Maastricht University.

Professional experienceBetween 1995 and 1997 Natasha worked as a doctor at St Luke’s Hospital in Malta and in 1997 she obtained the warrant to practice medicine from the Medical Council of Malta. Upon her return from London she worked within the office of the Chief Government Medical Officer in Malta and obtained her specialist certification Public Health Medicine. Between 2001 and 2013 she held a successive series of public service Headship positions within the Ministry of Health in Malta. During this period she represented the Ministry of Health in numerous international meetings and conferences. In 2001 she was appointed Director (Office of Review) and in 2004, following Malta’s accession to the European Union, she was appointed the first Director for EU and International Affairs and a member on the EU High Level Committee for Health. In 2007 she was promoted to the position of Director General (Strategy and Sustainability) and in 2011 she took up the position of Chief Medical Officer for Malta. In 2014 she moved out of the Ministry for Health and now works as a Consultant in Public Health Medicine at the Directorate for Health Information and Research.

Since 1999 Natasha has also held a resident academic position at the University of Malta. She lectures on health policy and health systems and has supervised several Master dissertations. Throughout her career, Natasha has participated actively in many

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conferences and meetings, delivering presentations and organizing sessions. She has been involved in EU research projects and collaborations. She is an Associate Editor for the European Journal of Public Health and BMC Health Services Research. Natasha is also the focal point in Malta for the Health Systems and Policy Monitoring Network of the European Observatory on Health Systems and Policies. She has collaborated with the Observatory on several reports and publications including the Malta country profiles for the Hit series in 1999 and 2014.

AdvocacyNatasha has always been highly active in non-governmental organisations. During her student years she was Vice-President of the Malta Medical Students Association, International Secretary of the University Student Council and President of the National Youth Council. As a junior doctor, she was a member on the Council of the Medical Association of Malta. Between 1994 and 1998 she was a Council Member of the Youth and Women’s Movements of the Nationalist Party. She then served as Secretary on the local committee of her place of residence for three years until she assumed a public service Headship position in 2001 when she terminated her involvement in politics. In 1999 she was a Founding Member of the Malta Association of Public Health Medicine and served on its Executive Council for nine years. During this period she worked towards the development of the public health specialty in Malta and between 2006 and 2008 was President of the Malta Association of Public Health Medicine. She has also been highly involved in public health advocacy at a European level. Between 2006 and 2014 she was President of the Section on Public Health Practice and Policy within the European Public Health Association. She is currently President-Elect of the European Public Health Association and will take up the role of President in November 2016.


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LIST OF PUBLICATIONS

Journal Articles in Peer-Reviewed JournalsAzzopardi-Muscat N, Funk T, Buttigieg S, Grech K, Brand H. Policy challenges and reforms in small EU Member State health systems: A narrative literature review. European Journal of Public Health. DOI 10.1093/eurpub/ckw091.

Azzopardi-Muscat N, Sorensen K, Aluttis C, Pace R., Brand H. Europeanisation of Health Systems: A qualitative study of domestic actors in a small state: BMC Public Health 2016; 16:334.

Azzopardi-Muscat N, Schroder-Back P, Brand H. The EU Joint Procurement Agreement for Cross Border Health Threats: What is the potential for this new mechanism of Health System collaboration? Accepted for publication in Health Economics Policy & Law.

Azzopardi-Muscat N, Aluttis C, Sorensen K, Pace R, Brand H. The impact of the EU Directive on patients’ rights and cross border health care in Malta. Health Policy 2015 Oct; 119(10) 1285-1292.

Azzopardi Muscat N, Clemens T, Stoner D, Brand Helmut. EU Country Specific Recommendations for Health Systems in the European Semester process: Trends, Discourse and Predictors. Health Policy 2015 Mar; 119(3): 375-383.

Saliba V, Azzopardi-Muscat N, Vella M, Montalto SA, Fenech C, McKee M, et al. Clinicians’, policy makers’ and patients’ views of pediatric cross-border care between Malta and the UK. Journal of Health Services Research & Policy 2014 July 01; 19(3):153-160.

Deguara L, Azzopardi Muscat N. Malta, the European Union and the Medical Profession: The EU accession process How EU membership will influence the Maltese Medical Profession. Malta Medical Journal 2002; 14 (1):9-11.

Commentaries and EditorialsAzzopardi Muscat N, Brand H. Will European Reference Networks herald a new era of care for patients with rare and complex diseases? European Journal of Public Health 2015 Jun; 25(3): 362-363.

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Azzopardi Muscat N. European-added value for public health. European Journal of Public Health 2015 Feb; 25(1):1.

Azzopardi Muscat N, Brand H. Ten years on: time for a public health celebration or sober reflection? European Journal of Public Health 2014 Jun; 24(3):351-352.

Azzopardi Muscat N. EU cross-border health care and public health. European Journal of Public Health 2010 Apr; (2):128-129.

Book ChaptersLazzari A, de Waure C, Azzopardi-Muscat N. Health in All Policies. In: Boccia S, Villari P, Ricciardi W, editors. A Systematic Review of Key Issues in Public Health. Springer; 2015.

Azzopardi Muscat N, Grech K. Malta. In: Bernd R, Dubois CA, McKee M, editors. The Health Care Workforce in Europe: Learning from Experience; Copenhagen. World Health Organisation; 2006.

Azzopardi Muscat N, Grech K, Cachia JM, Xuereb D. Sharing capacities:Malta and the United Kingdom. In: Rosenmoller M, McKee M, Baeten R, editors. Patient Mobility in the European Union Learning from Experience. Copenhagen: World Health Organization; on behalf of the Europe 4 Patients project and the European Observatory on Health Systems and Policies; 2006.

Technical ReportsAzzopardi-Muscat N. Malta. In: Maresso A; Mladovsky P, Thomson S, Sagan A, Karanikolos M, Richardson E, Cylus J,Evetovits T,Jowett M,Figueras J, editors. Economic crisis, health systems and health in Europe. World Health Organization ; 2015.

Azzopardi Muscat N, Calleja N, Calleja A, Cylus J. Health Systems in Transition Malta. Health 2014; 16(1).

Abela AM, Cordina G, Azzopardi Muscat N. Country Study Malta. In: Gesellschaft fur Versicherungswissenschaft und –gestaltung e V. Social Protection in the Candidate Countries Cyprus, Malta, Turkey: Country Report 43Malta. Berlin. IOS Press; 2003.

Azzopardi Muscat N, Dixon A Health Care Systems in Transition: Malta. Copenhagen. World Health Organisation; 1999.



Published Peer Reviewed Conference ProceedingsAzzopardi-Muscat N, Grech K, Calleja N. The performance of the Maltese health system: An idiosyncratic story. Eur J Public Health 2015 Oct 1; 25(suppl 3) ckv174.078.

Thyssen SG, Gauci D, Azzopardi-Muscat N. A qualitative study of the experiences of health information practitioners in a small European country. Eur J Public Health 2015 Oct 1; 25(suppl 3) ckv173.032.

Azzopardi-Muscat N, Thyssen SG, Stoner D, Calleja N. Factors affecting data availability in the European region. Does population size matter? Eur J Public Health 2015 Oct 1; 25(suppl 3) ckv173.029.

Azzopardi-Muscat N, Brand H. The ‘European Semester’: A growing force shaping Health Systems Policy and Reform in the European Union. Eur J Public Health 2014 Oct 1; 24(suppl 2):cku164. 089.

Azzopardi-Muscat N, Funk T, Buttigieg S, Grech K, Brand H. Challenges and policy concerns for health systems in small European states: Eur J Public Health 2014 Oct 1; 24(suppl 2):cku163.097.

Cylus JD, Azzopardi-Muscat N, Malta and Cyprus: What can they learn from each other and what lessons emerge for health system reformers? Eur J Public Health 2014 Oct 1; 24(suppl 2) cku163.098.

Azzopardi-Muscat N. European Union Structural and Investment (ESI) Funds: A mechanism for Europeanisation of Health Systems? Eur J Public Health 2014 Oct 1; 24(suppl 2):cku165. 022.

Azzopardi-Muscat N. The Maltese health system: leader or laggard in Europe? MJHS 2014 April 23; 1(suppl 1).

Borg AM, Azzopardi-Muscat N. Re-thinking the European Added Value of the European Union Patients’ Rights Directive. Eur J Public Health 2013 Oct 1; 23(suppl 1): ckt124.074.

Borg AM, Azzopardi-Muscat N, Brand H. Opportunities and challenges of cross-border health care: voices of Maltese thyroid cancer patients: Eur J Public Health 2013 Oct 1; 23(suppl 1): ckt126.046.

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210 | List of Publications

Azzopardi-Muscat N, Dalmas M, Brand H. Can small countries keep up in the cross border game? Eur J Public Health 2012; 22(suppl 2) p. 65-66.

Zahra Pulis I, Azzopardi Muscat N. Ensuring affordability and access to medicines in small markets. Eur J Public Health 2012; 22(suppl 2)66.

Azzopardi Muscat N. The effects of European policy developments on health services for small Member States and remote communities. Eur J Public Health 2007 Jan; 17 (suppl 2).

Azzopardi Muscat N. Health and the Strategic objectives of the EU: Synergy, Coherence and Compatibility: Eur J Public Health 2007 Jan; 17(suppl 2).

Azzopardi Muscat N, Grech K, Bezzina M. Harmonisation of public health practices as part of the accession process to the European Union: a country case study- Malta. Eur J Public Health 2003 Dec; 13:(4)48.

Presentations relevant to the PhD DissertationAzzopardi Muscat N, Briguglio L, Pace R. Leadership and Participatory Government in Small States: Implications for the Multi Sectoral Implementation of Health 2020. Second High Level Meeting for Ministers of Small States, WHO EURO; Andorra. July 1, 2015.

Azzopardi Muscat N. Health Starts with a Vision. European Public Health Conference, Department of International Health Maastricht University; Maastricht. 18 June, 2015.

Azzopardi Muscat N. European Health Policy and Austria: Achievements and Intentions. Symposium on Rethinking Health Policy from Austria to Europe and Back, European Health Forum Gastein / FOPI; Vienna. 9 April, 2015.

Azzopardi Muscat N, Clemens T. Country Specific Recommendations in the European Union. The International Dimension in Health Services Research Meeting, Health Services Research Section EUPHA, NIVEL; Utrecht. 15 May, 2014

Azzopardi Muscat N. A small country perspective on the future prospects of EU Health Policy European Public Health Conference- 20 years after the Maastricht Treaty: Turning past experiences into visions, Department of International Health Maastricht University; Maastricht. 22 May, 2013.



Azzopardi Muscat N. Structures and processes for cross border care referral: Committee on European Reference Networks, Brussels. 6 February, 2013.

Azzopardi Muscat N. The development of the Maltese health system in the context of European Union membership. UEMS meeting; Malta. 1 April, 2012.