This article has Open Peer Review reports available.
Europeanisation of health systems: a qualitative study of domestic actors in a small state
© Azzopardi-Muscat et al. 2016
Received: 11 September 2015
Accepted: 24 February 2016
Published: 14 April 2016
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.
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.
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.
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.
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) . 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 . 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 . The effects of austerity policies with the concomitant reduction in health budgets , 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 . 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 . 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 .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’ . This definition was selected because it includes policy instruments other than legislation and, therefore, is suitable for an assessment of health system Europeanisation considering that EU action in this policy area is often pursued through instruments other than legislation . 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 , 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 , although discredited as being too mechanistic and lacking empirical evidence in certain respects [25, 30], can still be usefully applied to an analysis of the Europeanisation of the Maltese health system. 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 [31–33] in determining the overall effects of the EU on individual Member States. 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.
Key facts about the Maltese health care system
Malta acceded to the EU in 2004. It is the smallest Member State 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 particularly 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 %. Sustainability of the health system has become identified as a key challenge and the Maltese health system has come under the scrutiny during 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.
Studies on the Europeanisation of health care were identified for cross-border mobility [36–38], health care coverage , alcohol policy , communicable disease policy [41, 42] and cancer . 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 .
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 .
Study participants and setting
Professional roles of participants interviewed
Number of participants
European affairs public officer
Ministry of Health (MoH) public officer
A 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.
An 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 . 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 .
General reflections on a decade of EU membership
‘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.
‘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).
‘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).
‘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
‘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).
‘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).
‘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 membership.4 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 funding.5 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 h 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.
‘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).
Health system transformation and adaptation (Malta 2004–2014)
Health system change
Public health policies and strategies
Non-binding EU communications, strategies, reportsParticipation in EU working groups
Domestic health policy-making process underwent significant change and a number of important health strategies were developed
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
EU funds for capacity building
Transposition of legislation and establishment of medical specialist registers as well as structured post graduate training programmes
Regulation of quality, safety and efficacy of medicines
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
Directives Participation in networks and working groups
Transposition of legislation and setting up of competent authorities for licensing providers and regulating public health standards
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
Inertia and resistance to health system reform (Malta 2004–2014)
Health system continuity
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
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
Transposition of minimal requirements of the directive
Pricing and reimbursement
Minimum requirements of the transparency directive on medicines were transposed but no major changes to the system of pricing or reimbursement were implemented
Extensive use of the ‘opt-out’ clause for doctors agreeing to work more than 48 h weekly so as to avoid major changes to the system
Funding of public health care
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
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.
Domestic health system stakeholder attitudes towards EU integration
‘Thank God that there is an obligation, so thank God for the EU!’ (#21 EU affairs public officer).
‘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).
‘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 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.
‘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).
‘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 Europeanisation
‘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).
‘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).
‘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).
‘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 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.
‘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).
‘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.
Summary of key findings
Figure 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 practice
Tables 3 and 4 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 . 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 [51–53] and both areas were highlighted as being impacted in pre-accession assessments of candidate countries , including Malta [55, 56]. The impact on the pharmaceutical sector in Malta was also previously described . 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. 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 materialise , and stakeholders appear to believe that an EU obligation would most likely have provided the necessary impetus for reforms to be implemented.
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.
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 [27, 60]–our findings indicate has mixed effects. 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 [62, 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 Europeanisation
A survey of European health stakeholders found mixed perceptions of whether or not role expansion should occur for the EU in health policy . 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’ . 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 . 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 [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 . 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.
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 [62, 71], our study found that this portrayal is not always the case. 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. The lack of public health research in small states has been described elsewhere [73–76] and the findings from this study serve to confirm that this lack of research remains a particular challenge for small states.
Critique of Europeanisation theory
The typical dilemma of establishing causality in Europeanisation research emerges in this study . 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 . 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 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 limitations
This study is innovative and attempts to cover a broad scope. Efforts were undertaken to ensure reflexivity through the research process . 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 . 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.
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?
The European Semester is an EU-level policy co-ordination tool that contributes towards the broader EU aims of strengthening economic governance and greater policy co-ordination. This tool provides a more integrated surveillance framework for the implementation of fiscal policies under the Stability and Growth Pact, and the implementation of structural reforms through national reform programmes. The Commission publishes Country-Specific Recommendations for each Member State on the basis of a thorough assessment of every Member State’s plans for sound public finances and policy measures to increase 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]
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.
English is an official language in the Republic of Malta.
The main health strategies published during 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 09/10/15].
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].
The research work disclosed in this publication is partly funded by the Malta Government Scholarship Scheme grant.
The authors would like to thank Enago (www.enago.com) for the English language review.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Consolidated Version of the Treaty on European Union. 2010; OJ C 83/01, art 168.Google Scholar
- Hervey T. The European Union and the Governance of health care. In: Búrca G, Scott J, editors. New Governance and Constitutionalism in the EU and the US. Oxford: Hart; 2006. p. 179–210.Google Scholar
- Lamping W, Steffen M. European Union and Health Policy: the “Chaordic” dynamics of integration. Soc Sci Q. 2009;90(5):1361–79.View ArticleGoogle Scholar
- Clemens T, Michelsen K, Brand H. Supporting health systems in Europe: added value of EU actions? Health Econ Policy Law. 2014;9(1):49–69.View ArticlePubMedGoogle Scholar
- Hervey T. Reflecting on ‘supporting health systems in Europe: added value of EU actions?’. Health Econ Policy Law. 2015;10(4):485–9.View ArticlePubMedGoogle Scholar
- Rosenkotter N, Clemens T, Sorensen K, Brand H. Twentieth anniversary of the European Union health mandate: taking stock of perceived achievements, failures and missed opportunities - a qualitative study. BMC Public Health. 2013;13:1074. 2458-13-1074.View ArticlePubMedPubMed CentralGoogle Scholar
- Greer SL. The European Centre for Disease Prevention and Control: hub or hollow core? J Health Polit Policy Law. 2012;37(6):1001–30.View ArticlePubMedGoogle Scholar
- Sorensen K, Clemens T, Rosenkotter N. The EU’s heath mandate after 20 years: the glass is half full. Eur J Public Health. 2013;23(6):906–7.View ArticlePubMedGoogle Scholar
- Greer SL. Glass half empty: the Eurozone and internal market overshadow the health effects of Maastricht. Eur J Public Health. 2013;23(6):907–8.View ArticlePubMedGoogle Scholar
- Greer SL. The three faces of European Union health policy: policy, markets, and austerity. Policy Soc. 2014;33(1):13–24.View ArticleGoogle Scholar
- Greer SL, Fahy N, Elliott HA, Wismar M, Jarman H, Palm W. Everything you always wanted to know about European Union Health Policies but were afraid to ask. Copenhagen: World Health Organisation; 2014.Google Scholar
- Greer SL. Uninvited Europeanization: neofunctionalism and the EU in health policy. J Eur Public Policy. 2006;13(1):134–52.View ArticleGoogle Scholar
- Fahy N. Who is shaping the future of European health systems? BMJ. 2012;344:e1712.View ArticlePubMedGoogle Scholar
- Kentikelenis A, Papanicolas I. Economic crisis, austerity and the Greek public health system. Eur J Public Health. 2012;22(1):4–5.View ArticlePubMedGoogle Scholar
- McKee M, Karanikolos M, Belcher P, Stuckler D. Austerity: a failed experiment on the people of Europe. Clin Med. 2012;12(4):346–50.View ArticleGoogle Scholar
- Cervero-Liceras F, McKee M, Legido-Quigley H. The effects of the financial crisis and austerity measures on the Spanish health care system: A qualitative analysis of health professionals’ perceptions in the region of Valencia. Health Policy. 2015;119(1):100–6.View ArticlePubMedGoogle Scholar
- 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;119(3):375–83.View ArticlePubMedGoogle Scholar
- 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;21(1):1–14.View ArticlePubMedGoogle Scholar
- Olsena S. Implementation of the Patients’ Rights in Cross-border Healthcare directive in Latvia. Eur J Health Law. 2014;21(1):46–55.View ArticlePubMedGoogle Scholar
- Bongers LM, Townend DM. The implementation of the Directive on the Application of Patients’ Rights in Cross-border Healthcare in the Netherlands. Eur J Health Law. 2014;21(1):65–78.View ArticlePubMedGoogle Scholar
- Kattelus M. Implementation of the Directive on the Application on Patient’s Rights in Cross-border Healthcare (2011/24/EU) in Finland. Eur J Health Law. 2014;21(1):23–32.View ArticlePubMedGoogle Scholar
- Requejo MT. Cross-border healthcare in Spain and the implementation of the Directive 2011/24/EU on the Application of Patient’s Rights in Cross-border Healthcare. Eur J Health Law. 2014;21(1):79–96.View ArticlePubMedGoogle Scholar
- 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;119(10):1285–92. October 2015 http://dx.doi.org/10.1016/j.healthpol.2015.08.015.View ArticlePubMedGoogle Scholar
- Juncker J. Mission Letter to Vytenis P. Andriukaitis Commissioner for Health and Food Safety. 2014; Available at: [http://ec.europa.eu/about/juncker-commission/docs/andriukaitis_en.pdf.] Accessed 2 December 2014.
- Radaelli CM, Pasquier R. Conceptual issues. In: Graziano P, Vink MP, editors. Europeanization: new research agendas. New York: Palgrave Macmillan; 2007. p. 35–45.Google Scholar
- Radaelli CM. The Europeanisation of Public Policy. In: Featherstone K, Radaelli CM, editors. The politics of Europeanization. Oxford: Oxford University Press; 2003. p.27–56.Google Scholar
- Greer SL, Vanhercke B. The hard politics of soft law: the case of health. In: Mossialos E, Permanand G, Baeten R, Hervey TK, editors. Health systems governance in Europe: the role of European Union law and policy. Cambridge: Cambridge University Press; 2010. p. 186–230.Google Scholar
- Radaelli CM. Whither Europeanization? Concept stretching and substantive change European Integration online Papers (EIoP) 2000; 4(8) Available at: [http://eiop.or.at/eiop/pdf/2000-008.pdf.] Accessed 26 August 2015.
- Börzel TA, Risse T. Conceptualizing the domestic impact of Europe. In: Featherstone K, Radaelli CM, editors. The politics of Europeanization. Oxford: Oxford University Press; 2003. p. 57–80.Google Scholar
- Harwood M. Europeanisation Chapter 3. In: Malta in the European Union. London: Ashgate Publishing, Ltd.; 2014. p. 15–28.Google Scholar
- Featherstone K. Cyprus and the onset of Europeanization: strategic usage, structural transformation and institutional adaptation. South Eur Soc Polit. 2000;5(2):141–64.View ArticleGoogle Scholar
- Ladrech R. Europeanization and national politics: Palgrave Macmillan. 2010.Google Scholar
- 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. London: Palgrave Macmillan; 2012. p. 141–59.Google Scholar
- Harwood M. An assessment of Malta’s Europeanisation experience. Chapter 8. In: Malta in the European Union. London: Ashgate Publishing, Ltd.; 2014. p. 195–228.Google Scholar
- Tabone P. Malta’s EU Story How Ten Years of EU Membership have changed the country. Malta: The Today Public Policy Institute; 2014.Google Scholar
- Kostera T. Europeanizing Healthcare: Cross-border Patient Mobility and Its Consequences for the German and Danish Healthcare Systems. Bruges Political Research Paper No. 7, May 2008.Google Scholar
- Baeten R, Vanhecke B, Coucheir M. The Europeanisation of national health care systems: creative adaptation in the shadow of patient mobility case law. OSE Paper Series; Research Paper No 3. 2010.Google Scholar
- Baeten R. Europeanization of national health systems, National impact and EU codification of the patient mobility case law. OSE Paper Series. July 2012.Google Scholar
- Böhm K, Landwehr C. The Europeanization of health care coverage decisions: EU-regulation, policy learning and cooperation in decision-making. J Eur Integration. 2014;36(1):17–35.View ArticleGoogle Scholar
- Cisneros Örnberg J. The Europeanization of Swedish alcohol policy. 2009. [dissertation on the Internet]. Stockholm (Sweden)]: Stockholm University; 2009 Available at: [http://www.diva-portal.org/smash/get/diva2:200235/FULLTEXT01.pdf&sa=U&ei=xvdMU6DaIoHlswblzIGYCA&ved=0CBsQFjAA&usg=AFQjCNF9TdZBxS5LTcFXkAjEDcc983iZ1Q.] Accessed 12 August 2015.
- Martin R, Conseil A. Public health policy and law for pandemic influenza: a case for European harmonization? J Health Polit Policy Law. 2012;37(6):1091–110.View ArticlePubMedGoogle Scholar
- Steffen M. The Europeanization of public health: how does it work? The seminal role of the AIDS case. J Health Polit Policy Law. 2012;37(6):1057–89.View ArticlePubMedGoogle Scholar
- Trubek L, Nance M, Hervey T. Construction of Healthier Europe: Lessons from the Fight against Cancer. Wis Int’l Law J. 2008;26:804.Google Scholar
- Exadaktylos T, Radaelli CM. Europeanisation. In: Lynggaard K, Manners I, Lofgren K, editors. Research Methods in European Studies. London: Palgrave Macmillan; 2015. p. 206–18.Google Scholar
- Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–57.View ArticlePubMedGoogle Scholar
- Rubin HJ, Rubin IS. Qualitative interviewing: The art of hearing data. California: Sage; 2011.Google Scholar
- Meyrick J. What is good qualitative research? A first step towards a comprehensive approach to judging rigour/quality. J Health Psychol. 2006;11(5):799–808.View ArticlePubMedGoogle Scholar
- Sedelmeier U. Europeanisation in new member and candidate states. In: Living Reviews in European Governance. 2006;1(3). Available at: [http://www.europeangovernance-livingreviews.org/] Accessed 12 August 2015.
- Scimmelfennig F, Sedelmeier U. Candidate Countries and Conditionality. In: Graziano P, Vink MP, editors. Europeanization: New research Agendas. London: Palgrave Macmillan; 2007. p. 88–101.Google Scholar
- Pace R. A small state and the European Union: Malta’s EU accession experience. South Eur Soc Polit. 2002;7(1):24–42.View ArticleGoogle Scholar
- Mossialos E, Permanand G, Baeten R, Hervey T. Health systems governance in Europe: the role of European Union law and policy. Cambridge: Cambridge University Press; 2010.Google Scholar
- McKee M, Mossialos E, Baeten R. The impact of EU law on health care systems. Brussels: P.I.E.-Peter Lang; 2002.Google Scholar
- Mossialos E, McKee M. EU Law and the Social Character of Health Care. Brussels: P.I.E -Peter Lang; 2002.Google Scholar
- McKee M, Maclehose L, Nolte E. Health policy and European Union enlargement. England: Open University Press; 2004.Google Scholar
- Deguara L, Azzopardi Muscat N. Malta, the European Union and the Medical Profession: II The EU accession process How EU membership will influence the Maltese Medical Profession. Malta Med J. 2002;14(1):9–11.Google Scholar
- Abela AM, Cordina G, Azzopardi Muscat N. Social protection in the candidate countries: Country studies Cyprus, Malta, Turkey: Country Report Malta. Amsterdam: IOS Press; 2003. p. 100–24.Google Scholar
- Bugeja V. The impact of EU legislation on medicines in Malta. J Malta Coll Pharm Pract. 2008;14(Summer Issue):34.Google Scholar
- Albreht T, Klazinga NS. Restructuring public health in Slovenia between 1985 and 2006. Int J Public Health. 2008;53(3):150–9.View ArticlePubMedGoogle Scholar
- Azzopardi Muscat N, Calleja N, Calleja A, Cylus J. Health system review Malta health systems in transition. Health. 2014;16:1.Google Scholar
- Greer SL. The weakness of strong policies and the strength of weak policies: Law, experimentalist governance, and supporting coalitions in European Union health care policy. Regul Gov. 2011;5(2):187–203.View ArticleGoogle Scholar
- Falkner G, Treib O, Holzleithner E. Introduction: The Challenge of Implementation Research in the New Member States. In: Falkner G, Treib O, Holzleithner E, editors. Compliance in the enlarged European Union: living rights or dead letters? London: Ashgate Publishing, Ltd.; 2008. p. 1–26.Google Scholar
- Thorhallsson B. The Role of Small States in the European Union. England: Ashgate; 2000.Google Scholar
- Panke D. Small states in the European Union: structural disadvantages in EU policy-making and counter-strategies. J Eur Public Policy. 2010;17(6):799–817.View ArticleGoogle Scholar
- HM Government. Review of the Balance of Competences between the United Kingdom and the European Union Health. HM Government Crown Copyright United Kingdom; July 2013. [Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/224715/2901083_EU-Health_acc.pdf] 29 January 2015.
- Pace R. Malta and EU membership: overcoming ‘vulnerabilities’, strengthening ‘resilience’. Eur Integration. 2006;28(1):33–49.View ArticleGoogle Scholar
- Bailes AJ, Thorhallsson B. Instrumentalizing the European Union in small state strategies. J Eur Integration. 2013;35(2):99–115.View ArticleGoogle Scholar
- Jacobson PD. The role of networks in the European union public health experience. J Health Polit Policy Law. 2012;37(6):1049–55.View ArticlePubMedGoogle Scholar
- Frenk J, Gómez-Dantés O, Moon S. From sovereignty to solidarity: a renewed concept of global health for an era of complex interdependence. Lancet. 2014;383(9911):94–7.View ArticlePubMedGoogle Scholar
- European Commission and signatory Member States. Joint Procurement Agreement to procure Medical Countermeasures. 2014. [Available at: http://ec.europa.eu/health/preparedness_response/joint_procurement/index_en.htm] Accessed 29 January 2015.
- European Commission Expert Group on Safe and Timely Access to Medicines for Patients (“STAMP”). 2015; [http://ec.europa.eu/health/documents/pharmaceutical-committee/stamp/index_en.htm] Accessed 20 August 2015.
- Grøn CH, Wivel A. Maximizing influence in the European Union after the Lisbon treaty: from small state policy to smart state strategy. J Eur Integration. 2011;33(5):523–39.View ArticleGoogle Scholar
- Pace A, Azzopardi LM, Serracino-Inglott A, Wismayer L, Adami MZ. Development in the European Union and access to medicines. Pharm Glob (IJCP). 2013;4(6):1–7.Google Scholar
- Clarke A, Gatineau M, Grimaud O, Royer-Devaux S, Wyn-Roberts N, Le Bis I, et al. A bibliometric overview of public health research in Europe. Eur J Public Health. 2007;17 Suppl 1:43–9.View ArticlePubMedGoogle Scholar
- Conceicao C, Leandro A, McCarthy M. National support to public health research: a survey of European ministries. BMC Public Health. 2009;9:203.View ArticlePubMedPubMed CentralGoogle Scholar
- Conceição C, McCarthy M. Public health research systems in the European Union. Health Res Policy Syst. 2011;9:38.View ArticlePubMedPubMed CentralGoogle Scholar
- McCarthy M. Public health research support through the European structural funds in central and eastern Europe and the Mediterranean. Health Res Policy Syst. 2012;10:12.View ArticlePubMedPubMed CentralGoogle Scholar
- Exadaktylos T, Radaelli CM. Looking for causality in the Literature on Europeanisaiton. In: Exadaktylos T, Radaelli CM editors. Research design in European studies: Establishing causality in Europeanization. London: Palgrave Macmillan; 2012. p. 17–43.Google Scholar
- Radaelli CM. Europeanization: The Challenge of Establishing Causality. In: Exadaktylos T, Radaelli CM, editors. Research Design in European Studies: Establishing Causality in Europeanization. England: Palgrave Macmillan; 2012. p. 1–16.Google Scholar
- Dwyer SC, Buckle JL. The space between: on being an insider-outsider in qualitative research. Int J Qual Methods. 2009;8(1):54–63.Google Scholar