Cross-border care and healthcare quality improvement in Europe: the MARQuIS research project

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1 1 Avedis Donabedian Institute, Autonomous University of Barelona, and CIBER Epidemiology and Publi Health (CIBERESP), Spain; 2 European Hospital and Healthare Federation (HOPE), Brussels, Belgium; 3 Patient Safety and Risk Management in Health Care Systems, Department of Health Eonomy, Shool of Publi Health, University of Brussels, Brussels, Belgium Correspondene to: R Suñol, Avedis Donabedian Institute, Provenza 293 Pral, Barelona 08037, Spain; fad@ fadq.org Aepted 12 November 2008 This paper is freely available online under the BMJ Journals unloked sheme, see qsh.bmj.om/info/unloked.dtl Cross-border are and healthare quality improvement in Europe: the MARQuIS researh projet R Suñol, 1 P Garel, 2 A Jaquerye 3 ABSTRACT Citizens are inreasingly rossing borders within the European Union (EU). Europeans have always been free to travel to reeive are abroad, but if they wished to benefit from their statutory soial protetion sheme, they were subjet to their loal or national legislation on soial protetion. This hanged in 1991 with the European Court of Justie defining healthare as a servie, starting a debate on the right balane between different priniples in European treaties: movement of persons, goods and servies, versus the responsibility of member states to organise their healthare systems. Simultaneously, rossborder ooperation has developed between member states. In this ontext, patient mobility has beome a relevant issue on the EU s agenda. The EU funded a number of Sientifi Support to Poliies (SSP) ativities within the Sixth Framework Programme, to provide the evidene needed by EU poliy makers to deal with issues that European itizens fae due to enhaned mobility in Europe. One SSP projet Methods of Assessing Response to Quality Improvement Strategies (MARQuIS), foused on ross-border are. It aimed to assess the value of different quality strategies, and to provide information needed when: (1) ountries ontrat are for patients moving aross borders; and (2) individual hospitals review the design of their quality strategies. This artile desribes the European ontext related to healthare, and its impliations for ross-border healthare in Europe. The bakground information demonstrates a need for further researh and development in this area. The aim of this paper is to desribe the European ontext related to healthare, and its impliations for ross-border healthare in Europe. The bakground information demonstrates the need for further researh and development in this area. As a response to this need, the European Commission funded the Methods of Assessing Response to Quality Improvement Strategies (MARQuIS) researh projet. This artile omprises two main setions: a desription of the European ontext, and a desription of the MARQuIS projet itself. THE EUROPEAN CONTEXT Citizens are inreasingly rossing borders within the European Union (EU). The vast majority travel for reasons unrelated to healthare. In some ases, these movements give rise indiretly to demands on health servies, and in others patients may diretly seek speifi are servies in other member states. Qual Saf Health Care 2009;18(Suppl I):i3 i7. doi: /qsh Europeans have always been free to travel to reeive are in other member states, but if they wished to benefit from their statutory soial protetion sheme, they were subjet to their loal or national legislation on soial protetion. Aording to artile 22 of Regulation no. 1408/71, they ould benefit from health servies in another European Eonomi Area ountry, with aess to emergeny are during short-term stays. They needed, however, prior authorisation for eletive are in another member state sine the range of available benefits was limited to those overed in the ountry of insurane. 1 This was hallenged in 1991, when the European Court of Justie defined healthare as a servie. 2 Consequently, in the wellknown Kohll and Deker rulings of 1998, and subsequent ases, the European Court of Justie established a new type of ross-border aess to health servies in the EU. Aording to treaty priniples of free movement of persons, goods and servies, itizens should be able to go abroad for non-hospital are treatment at the expense of their statutory soial protetion sheme. 3 Built on artiles 28 and 30 (free movement of goods) and artiles 49 and 50 (free movement of servies) of the treaty, this jurisprudene urges member states to suppress barriers to fundamental freedoms. Those new rules apply to soial insurane systems as well as to national health servies, aording to the Watts rulings of 16 May The above jurisprudene started a debate on the right balane between different priniples in European treaties: on the one hand, free movement of people, goods and servies, and on the other hand the responsibility of member states to organise their healthare systems. The healthare field is essentially guided in the treaties by the rules of national sovereignty, onto whih is grafted the ommunity priniple of subsidiarity: the Community only intervenes in those fields whih are not part of its exlusive ompetene suh as publi health, if and to the extent that, beause of their dimension or their effet, the objetives of the envisaged ation would be better ahieved at Community level. Exept for partiular instanes, the level of suitable administration for a funtion remains the most deentralised level. The member states have thus deided that the state or regional level is the most appropriate for deisions regarding health. Consequently, Community ations with regard to soial or health matters are only legitimate if they add to or strengthen those arried out at the i3 Qual Saf Health Care: first published as /qsh on 2 February Downloaded from on 17 August 2018 by guest. Proteted by opyright.

2 national level. Based on this and up to now, the majority of Community legislation enated in the field of health has not fundamentally transformed the way health systems operate in the ountries of Europe, as the treaties have only given the EU very tenuous powers over health systems. This reflets the diversity that is at the very origin of European soial systems, themselves refleted in the differenes in the onstitutional and administrative organisation of member states. And this diversity also holds within ountries: the number of states in Europe whih authorise regions to intervene appreiably in the field of health has markedly inreased in the past 30 years. The ontent of regional health powers is itself variable. It may be minimal, as in the implementation of national health legislation and the management of part of the health system, or maximal, as in deision-making powers for regulation, health planning, finaning and the supply of hospital are. With partiular referene to hospitals, major differenes in systems may be measured with a few key elements. First, the means of aess to hospitals an be very different from one member state to another. National hospital strutures are also highly varied, espeially in terms of the division between publi and private, and within the private setor, between for-profit and non-for-profit organisations. As this onerns the burden of publi hospital osts within the national total health budget, suh differenes in the organisation of systems ause signifiant budgetary differenes. On further analysis, it is also lear that the models of medial organisation, internal management and deision-making powers in hospitals are very different from one member state to another. Convergene is, however, growing for various reasons: ost ontainment, innovation, onsumerism, ageing, et. This is visible in poliies for aess, quality and finaning of hospitals. The onstrution of the EU has itself been the basis of a number of ations, leading to a ertain degree of onvergene. Legislation is in plae onerning drugs and medial devies, based on free movement of goods. The mutual reognition of professional qualifiations is also partiularly important in the healthare setor, as a driving fore of onvergene. Artile 152 of the Treaty of Amsterdam (1997) widened the powers of the Union with regard to publi health by onferring on it genuine deision-making powers in ertain fields. This is partiularly true with regard to the quality and seurity of organs and substanes of human origin and blood and its derivatives. Regardless of inreased reimbursement of are made possible under EU jurisprudene, ross-border ooperation has also developed between several member states for example, Belgium and Frane, Germany and Luxembourg, and the Netherlands and the UK. 1 With the finanial help of INTERREG (Innovation & Environment Regions of Europe Sharing Solutions) programmes, initiatives to improve the soial and eonomi situation were developed in border regions to failitate the administrative proedures, and to extend ontrats for providing benefits-in-kind aross borders. Cross-border are also means mobility of health professionals, and the way this should be monitored to ensure quality of are. 4 5 In this ontext, patient mobility has beome a relevant issue on the EU s agenda. The need to respond to the jurisprudene of the European Court of Justie led to the reation of a high-level proess of refletion on patient mobility in 2002 to disuss issues related to a growing number of patients in speifi situations, inluding border regions, highly speialised are, tourists and people residing in another ountry. A high-level group on health servies and medial are was set up in 2004 to follow developments. Various working groups prepared i4 onrete proposals for the ministers of health about possible ways to improve ooperation and exhange of information between member states at the European level. In this high-level group, member states have been asked to debate issues of growing patient mobility, and to fous greater attention on ross-border healthare. Some areas for attention thus far have been the provision of better information systems on spare apaity aross the EU to redue waiting lists for operations, onduting joint health tehnology assessment, reating European entres of referene for therapies involving advaned tehnologies and treatments for rare diseases, and the development of a ommon definition of rights, entitlements, and duties of patients at the European level. In June 2006, the ministers of EU member states approved the following values and priniples for all member state health servies: universality (aess to healthare must be ensured for every person living in the European Union); aess to good quality are; equity (equal aess to healthare regardless of ethniity, gender, age, soial status and ability to pay) solidarity (linked to the finanial shemes under whih the health systems are funded). The priniples also state that reduing health inequalities must be one of the aims of health systems, as well as a shift towards preventive measures. Following the exlusion of healthare servies from the Servies Diretive adopted in 2006, the European Commission was asked to work on a strategy for patient mobility that failitated progress while respeting national responsibility for health systems. Again, the issue of the right balane between free movement and the responsibility of member states to protet their itizens and organise their healthare systems was debated in the onsultation proess whih should lead to a diretive in this field. On a global level, trade in health servies aross borders have brought mixed benefits. 6 The main onerns are that unontrolled patient hoie will damage some national health systems, treatments abroad will ost more and national authorities will be unable to regulate rates of treatment and spending, national health systems will be left with half-empty institutions, the system overall will beome ineffiient, medial staff will migrate aross borders, and ategories of are and entitlements will be defined differently internationally. 4 Therefore, if trade in health servies is to ontinue, poliy makers must at to mitigate any adverse onsequenes and failitate the gains. 4 At the same time, healthare systems in member states fae inreasing pressures and demands in terms of universal aess to servies, ost ontainment and sustainability of finaning. 7 This has led to the rapid growth of global interest in the evaluation of healthare, due to the inreasing need within individual ountries to monitor the use of sare resoures to deliver healthare, and the quality of those servies. 8 Inreasing the value of health systems requires experimentation and performane measurement using ationable and speifi indiators, benhmarking within and aross borders, and the sharing of information, making further work at the international level imperative. 9 Through international ollaboration, experienes an be exhanged, providing evidene of what works and what does not, providing the knowledge for evidene-based pratie. 10 On the researh side, the EU has funded a number of Sientifi Support to Poliies (SSP) ativities within the Sixth Framework Programme, with the aim of providing the evidene Qual Saf Health Care 2009;18(Suppl I):i3 i7. doi: /qsh Qual Saf Health Care: first published as /qsh on 2 February Downloaded from on 17 August 2018 by guest. 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3 needed by EU poliy makers to deal with issues that European itizens fae as a result of enhaned mobility in Europe. The Europe4Patients projet (e4p, ) explored the impat of an integrated Europe on patients, in terms of the potential benefits through developments suh as greater aess to entres of exellene, and ations that overome transfrontier imbalanes between demand and supply. The Health Basket projet (2004 7) intended to provide information to national and EU poliy makers on reliable omparisons about available health servies in European member states, how these are defined, what their osts are and the pries. The MARQuIS researh projet we present in this supplement is one of the SSP projets that foused on ross-border are. THE MARQUIS PROJECT Aim and oneptual framework MARQuIS intends to assess the value of different quality strategies, and to provide the information needed when ountries ontrat are for patients moving aross borders, and when individual hospitals review the design of their quality strategies. The results are intended to provide evidene-based advie for the further development of formal quality proedures at the EU level either for healthare institutions or for developing existing approahes. The MARQuIS projet has adopted a definition of rossborder are that inludes five ategories of mobile patients. 11 Due to the diffiulties in identifying the different ategories in urrent healthare databases, these five ategories have been defined in desriptive terms for the projet as follows: itizens who, while on holiday, need to use healthare servies in the ountry they are visiting. In these ases, there are arrangements throughout the European Eonomi Area (EEA) to failitate the proess, onferring the right to treatment during a temporary visit; itizens who retire to a different ountry and wish to use the healthare system of the ountry where they are urrently living; people sharing lose ultural or linguisti links with the region where are is provided. This patient group also inludes migrants returning to their ountry of origin to reeive are; patients who ross a border to reeive healthare or to buy health goods. This is often beause of pereived advantages Figure 1 Dimensions of quality from the PATH theoretial model for hospital performane. 14 Qual Saf Health Care 2009;18(Suppl I):i3 i7. doi: /qsh related to quality, aessibility or pries, speifially out-ofpoket payments borne by patients; patients who are sent abroad by their own health system to overome apaity restritions at home. Some patients ross borders within the framework of ooperative agreements in order to share failities, espeially in relation to apitalintensive or highly speialised servies. To study quality of are in the MARQuIS projet we hose the dimensions of quality of the PATH (Performane Assessment Tool for Quality Improvement in Hospitals) oneptual framework, developed by the World Health Organization (WHO) Regional Offie for Europe, 12 sine it provides an up-to-date, omprehensive framework for hospitals, based on previous existing knowledge. The PATH oneptual framework advoates a multidimensional approah with six interrelated dimensions that should be assessed simultaneously. Two of these dimensions (safety and patient-entredness) ut aross the other four dimensions (linial effetiveness, effiieny, staff orientation and responsive governane), sine they are inter-related. Figure 1 is a graphial representation of this framework. The MARQuIS projet fouses mainly on the two entral dimensions (safety and patient-entredness) due to their relevane and inter-relation with the other dimensions, and also explores linial effetiveness. Methods A multimethod approah involving qualitative and quantitative methods was hosen, and inluded literature review, qualitative studies, questionnaires and visits to entres to verify questionnaire data and obtain omplementary information. To fulfil its objetives, the MARQuIS projet was designed in four stages, to last for 3 years (2004 7, extended to June 2008). The information from eah stage was to be used as the basis for the following stage. Figure 2 shows a basi sheme of the stages of the MARQuIS projet. First stage The first stage of the projet foused on the review and desriptive analysis of the urrent situation in Europe regarding, on the one hand, quality improvement and, on the other hand, ross-border are. To explore quality improvement, a survey was onduted of key experts in quality improvement from the 25 EU member states making up the EU in 2005 to gather information about views and aounts of quality improvement poliies and strategies in different healthare systems. To analyse ross-border are, diretives of the EU with respet to patient safety, empowerment and aess aross borders were reviewed. Data on foreign admissions were olleted to identify quantity and type of ross-border are ourrene in Europe. Additional information about this stage is desribed by Spener and Walshe. 13 Seond stage The seond stage foused on the identifiation of key requirements for seuring patient empowerment and safety in hospital are. To this end we reviewed some EU diretives pertaining to patient safety, empowerment and aess aross borders. Furthermore, a qualitative study with semi-strutured interviews of patients, professionals and finaners was arried out to explore their views regarding quality requisites mainly related to safety and patient-entredness when reeiving or providing ross-border are. 14 Finally, an exploratory study was done to i5 Qual Saf Health Care: first published as /qsh on 2 February Downloaded from on 17 August 2018 by guest. Proteted by opyright.

4 Figure 2 Sheme of the stages of MARQuIS projet. AMI, aute myoardial infartion. estimate volume and determine the most ommon onditions that led to hospitalisation of European ross-border patients. 15 Third stage The third stage of the projet built on the information olleted in the two previous stages of the projet, and aimed to desribe in a sample of states how hospitals have applied national quality strategies, how far they meet the defined requirements of rossborder patients, and what variables of organisation and methodology are assoiated with meeting these requirements. The information was olleted during the MARQuIS field test, whih onsisted of two main phases. In the first phase a rosssetional survey of hospitals was done with a self-administered i6 Key messages Citizens are inreasingly rossing borders within the EU In the EU, health planning, organisation and delivery are the responsibility of member states. Intervention by the EU is based on the priniple of subsidiarity, and overs areas suh as publi health or legislation on general interest topis suh as drug approval In 1991 the European Court of Justie defined healthare as a servie, and started a debate on the balane between the free movement of persons, goods and servies (established in EU treaties) versus the responsibility of member states to organise their healthare systems The EU funded a number of Sientifi Support to Poliies (SSP) researh projets within the Sixth Framework Programme, with the aim of providing the evidene needed by EU poliy makers to deal with deisions faed as a result of enhaned mobility in Europe MARQuIS is one suh projet, whih aimed to assess the value of different quality strategies, and to provide the information needed when ountries ontrat are for patients moving aross borders, and when individual hospitals review the design of their quality strategies The projet involved 389 hospitals in eight ountries and inluded an audit via on-site visits to 89 of them questionnaire. In the seond phase an on-site audit was done of a sample of the hospitals that partiipated in the questionnaire survey. Both the questionnaire and the audit examined quality improvement at two levels: hospital management and ward. Three wards were seleted based on the most frequent diagnoses identified in ross-border are in previous stages of the projet: aute myoardial infartion, deliveries and appendiitis. Eight European ountries partiipated in the field test: Belgium, Czeh Republi, Frane, Ireland, Poland, Spain, the Netherlands, and the UK. These ountries were seleted mainly based on feasibility harateristis: a national ageny with healthare assessment experiene and a solid reputation in the ountry was needed to be able to promote hospital partiipation in the study, and to perform assessments of hospitals. The methods for the field test are desribed elsewhere. Fourth stage The fourth stage onsisted of the aggregation and analyses of findings from all previous stages in order to draw onlusions and develop reommendations to poliy makers at the EU as well as the national level. Reommendations for healthare organisations and professional organisations were also drawn from the information and distributed for onsultation to member states and key stakeholders. 18 Results The MARQuIS projet olleted self-reported data from 389 hospitals in eight European ountries, and inluded an external assessment of 89 of these hospitals. In all, the study involved 16 European organisations (universities, areditation bodies, sientifi soieties and federations) related to healthare quality, and more than 30 professionals. In addition to the professionals diretly involved in the projet, an advisory ounil of more than 15 international experts provided reommendations to the researh team. The sientifi results and reommendations of this projet are presented here. CONCLUSION The suessful ompletion of this projet an be onsidered an aomplishment in itself. The multinational and multiultural Qual Saf Health Care 2009;18(Suppl I):i3 i7. doi: /qsh Qual Saf Health Care: first published as /qsh on 2 February Downloaded from on 17 August 2018 by guest. Proteted by opyright.

5 approah favoured international information exhange, whih in itself an ontribute to self-learning and homogenisation of the work in different ountries. This self-learning and homogenisation proess seems ruial in the evolving European ontext. For this reason the authors advoate the promotion of further international researh foused on the quality of European healthare. Funding: This researh was funded by the European Commission through its Sientifi Support to Poliies ation under the Sixth Framework Programme for Researh, through the Methods of Assessing Response to Quality Improvement Strategies (MARQuIS) researh projet (SP21-CT ). Competing interests: None. REFERENCES 1. Busse R. Border-rossing patients in the EU. Eurohealth 2002;8: Eur-Lex. Case C-159/90, Soiety for the Protetion of Unborn Children Ireland Ltd v Stephen Grogan and others, 4 Otober Searh via (aessed 9 De 2008). 3. Davies G. Health and effiieny: ommunity law and national health systems in the light of Müller-Fauré. Modern Law Rev 2004;67: Tjadens F. Registration and supervision of health professionals in EEA ountries. Maastriht: Netherlands Institute for Care and Welfare, (aessed 9 De 2008). 5. Legido-Quigley H, MKee M, Walshe K, et al. How an quality of health are be safeguarded aross the European Union? BMJ 2008;336: Chanda R. Trade in health servies. Bull World Health Organ 2002;80: Qual Saf Health Care 2009;18(Suppl I):i3 i7. doi: /qsh Koivusalo M. European health poliies moving towards markets in health? Eurohealth 2004;9: Heidemann EG. Moving to global standards for areditation proesses : the ExPeRT Projet in a larger ontext. Int J Qual Health Care 2000;12: Organisation for Eonomi Co-operation and Development. Towards highperforming health systems. Summary Report. Paris: The OECD Health Projet, Rolfe MK, Bryar RM, Hjelm K, et al. International ollaboration to address ommon problems in health are: proesses, pratialities and power. Int Nurs Rev 2004;51: Rosenmöller M, MKee M, Baeten R. Patient mobility in the European Union. Learning from experiene. Geneva: World Health Organization, 2006, on behalf of the Europe 4 Patients projet and the European Observatory on Health Systems and Poliies. 12. World Health Organization. Performane assessment tool for quality improvement in hospitals. Copenhagen: WHO, pdf (aessed 28 Nov 2008). 13. Spener E, Walshe K. National quality improvement poliies and strategies in European healthare systems. Qual Saf Health Care 2009;18(Suppl I):i Groene O, Poletti P, Vallejo P, et al. Quality requirements for ross-border are in Europe: a qualitative study of patients, professionals and healthare finaniers views. Qual Saf Health Care 2009;18(Suppl I):i Vallejo P, Suñol R, Van Beek B, et al. Volume and diagnosis: an approah to rossborder are in eight European ountries. Qual Saf Health Care 2009;18(Suppl I):i Lombarts MJMH, Rupp I, Vallejo P, et al. Appliation of quality improvement strategies in 389 European hospitals: results of the MARQuIS projet. Qual Saf Health Care 2009;18(Suppl I):i Shaw C, Kutryba B, Crisp H, et al. Do European hospitals have quality and safety governane systems and strutures in plae? Qual Saf Health Care 2009;18(Suppl I):i Groene O, Klazinga N, Walshe K, et al. Learning from MARQuIS: the future diretion of quality and safety in hospital are in the European Union. Qual Saf Health Care 2009;18(Suppl I):i i7 Qual Saf Health Care: first published as /qsh on 2 February Downloaded from on 17 August 2018 by guest. Proteted by opyright.