Quarterly of the European Observatory on Health Systems and Policies EUROHEALTH European incorporating Euro Observer

on Health Systems and Policies RESEARCH • DEBATE • POLICY • NEWS

❚ Nursing in the European Union ❚ Health priorities of the

› 2016 The changing Dutch Presidency ❚ Nurse migration: a moving target? |

❚ Implementation of Patients’ role of nursing ❚ EU accession: a policy Rights Directive window for nursing?

❚ Making sense of EU law Number 1

❚ Is there an EU framework | for nurse education? ❚ Managed Entry Agreements in the Baltic States

Volume 22 1356 ISSN Still Steve Production: and Design permission. prior without form any in transmitted or system aretrieval in stored reproduced, copied, be may publication this of part No 2016. Policies and Systems Health on Observatory European of behalf on © WHO Medicine. &Tropical Hygiene of School London the and Science Political and Economics of School London Funds), Insurance Health of Union National (French UNCAM Bank, World the Commission, European the Italy, of Region Veneto the and Kingdom United the Sweden, Slovenia, Norway, Ireland, Finland, Belgium, Austria, of Governments the Europe, for Office Regional Organization Health World the between apartnership is Policies and Systems Health on Observatory European The consideration. for authors by submitted or editors the by commissioned independently are Articles sponsors. or partners its of any or Policies and Systems Health on Observatory European the of those necessarily not and alone authors in expressed views The beyond. and Europe in debate aconstructive to contribute so and issues policy health on views their express to policymakers and experts researchers, for Eurohealth at: Available Guidelines Submission Article White: Caroline MANAGER SUBSCRIPTIONS North: Jonathan MANAGER PRODUCTION Still: Steve EDITOR DESIGN B. Richard Mossialos, Elias McKee, Martin Lessof, Suszy Palm, Willy Grand, Le Julian Holland, Walter Figueras, Josep Busse, Reinhard Belcher, Paul BOARD ADVISORY EDITORIAL aboutUs/LSEHealth/home.aspx http://www2.lse.ac.uk/LSEHealthAndSocialCare/ 6803 7955 20 +44 F: 6840 7955 20 T: +44 Kingdom United 2AE, WC2A London Street, Houghton Science Political and Economics of School London Health, LSE Mossialos: Elias EDITOR FOUNDING Palm: Willy ADVISOR EDITORIAL 6381 7955 20 +44 McDaid: David Maresso: Anna 6194 7955 20 +44 Merkur: Sherry TEAM EDITORIAL SENIOR http://www.healthobservatory.eu Email: 0936 2525 +32 F: 9240 2524 T: +32 Belgium Brussels, 1060 Horta Victor Place 07C020) (Office Eurostation Policies and Systems Health on Observatory European the of Quarterly EUROHEALTH [email protected] is a quarterly publication that provides a forum aforum provides that publication aquarterly is Saltman, Sarah Thomson Thomson Sarah Saltman, – [email protected] [email protected] 1030 http://tinyurl.com/eurohealth [email protected] [email protected] [email protected] [email protected] / 40 Hortaplein, Victor Eurohealth

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CONTENTS 1

EDITORS’ COMMENT List of Contributors 2 Linda H. Aiken w Center for Health Outcomes and Policy Research, University of Pennsylvania, USA Janet E. Anderson w Florence Nightingale Eurohealth Observer Faculty of Nursing and Midwifery, King’s College, London, United Kingdom THE STATE OF NURSING IN THE EUROPEAN UNION – Dia¯na Ara¯ja w Department of 3 Britta Zander, Linda H. Aiken, Reinhard Busse, Anne Marie Pharmacy, Ministry of Health, Latvia Louise Barriball w Florence Nightingale Rafferty, Walter Sermeus and Luk Bruyneel Faculty of Nursing and Midwifery, King’s College, London, United Kingdom NURSE MIGRATION IN THE EU: A MOVING TARGET? – Luk Bruyneel w Leuven Institute for Healthcare Policy, University 7 Claudia Leone, Ruth Young, Diana Ognyanova, Anne Marie of Leuven, Belgium Rafferty, Janet E. Anderson and Gilles Dussault Reinhard Busse w Department of Health Care Management, Berlin University of Technology, Germany EU ACCESSION: A POLICY WINDOW FOR NURSING? – Jonathan Cylus w European Observatory 10 Paul De Raeve, Anne Marie Rafferty and Louise Barriball on Health Systems and Policies, UK Paul De Raeve w King’s College London and European Federation of IS THERE AN EU FRAMEWORK FOR NURSE Nurses Associations (EFN), Belgium 14 EDUCATION? – Tom Keighley Gilles Dussault w Institute of Hygiene and Tropical Medicine, Nova University of Lisbon, Portugal Josep Figueras w European Observatory Eurohealth International on Health Systems and Policies, Belgium Tamara Hervey w School of Law, University of Sheffield, England THE NETHERLANDS EU PRESIDENCY ON HEALTH – Tom Keighley w independent health 17 Edith Schippers care consultant, United Kingdom Keili Kõlves w Medicines and THE CROSS-BORDER CARE DIRECTIVE: Medical Devices Division, Estonian Health Insurance Fund, Estonia 20 IMPLEMENTATION STATUS – Willy Palm Claudia Leone w Florence Nightingale CONTENTS Faculty of Nursing and Midwifery, MAKING SENSE OF EUROPEAN UNION HEALTH LAW – King’s College, London, United Kingdom Diana Ognyanova w Department 24 Tamara Hervey of Health Care Management, Berlin University of Technology, Germany Willy Palm w European Observatory on Health Systems and Policies, Belgium Eurohealth Systems and Policies Martin McKee w European Observatory on Health Systems and Policies, UK MANAGED ENTRY AGREEMENTS FOR NEW MEDICINES Ellen Nolte w European Observatory on Health Systems and Policies, UK IN THE BALTIC COUNTRIES – Dia¯ na Ara¯ ja and Keili Kõlves 27 Anne Marie Rafferty w Florence Nightingale Faculty of Nursing and Midwifery, King’s College, London, United Kingdom Edith Schippers w Minister for Health, Opinion Welfare and Sport, The Netherlands WHAT, IF ANYTHING, DOES THE EURO HEALTH Walter Sermeus w Leuven Institute for Healthcare Policy, 31 CONSUMER INDEX ACTUALLY TELL US? – Jonathan University of Leuven, Belgium Cylus, Ellen Nolte, Josep Figueras and Martin McKee Ruth Young w Florence Nightingale Faculty of Nursing and Midwifery, King’s College, London, United Kingdom Britta Zander w Department of Health Care Management, Berlin University of Technology, Germany Quarterly of the European Observatory on Health Systems and Policies Eurohealth Monitor EUROHEALTH European incorporating Euro Observer on Health Systems and Policies RESEARCH • DEBATE • POLICY • NEWS 33 NEW PUBLICATIONS 34 NEWS

❚ Nursing in the European Union ❚ Health priorities of the

› 2016 The changing Dutch Presidency ❚ Nurse migration: a moving target? |

❚ Implementation of Patients’ role of nursing ❚ EU accession: a policy Rights Directive window for nursing?

❚ Making sense of EU law Number 1

❚ Is there an EU framework | for nurse education? ❚ Managed Entry Agreements in the Baltic States

Volume 22 © Ambientideas | Dreamstime.com

Eurohealth incorporating Euro Observer — Vol.22 | No.1 | 2016 2

There is no doubt that the role of nurses has been changing over the past few decades, not only in terms of their evolving clinical and managerial responsibilities but also in terms of their education and training. These processes have been affected in many ways by developments at the European level, not least through directives on the free movement of professionals, as well as the mutual recognition of professional qualifications.

In this Spring issue, Zander et al. kick off the have a strong cross-border dimension. In his article Observer section by outlining the main findings on the implementation of the Directive on patients’ of a wide-ranging and multi-country study on the rights in cross-border health care, Palm discusses current European nurse workforce and how the the reasons why patient mobility remains quite low work environment and qualifications impact on and highlights how national variations in transposition, retention rates, job satisfaction and patient care. interpretation and transparency have created Delving more deeply into the theme of nurse persistent hurdles. Completing this section is an article workforce migration, Leone et al. cast light on the by Hervey assessing the claims made by the health complex combination of factors that shape the policy community on the impact of European Union debate on the current imbalance of nurse supply health law. Her detailed assessment is presented and demand across European Union Member through the lens of four themes: consumerism; States. The authors use the United Kingdom and rights; equality, solidarity, and competition; and risk. Portugal as illustrative case studies on the impact of increased mobility caused by some countries Finally, in the Systems and Policies section Ara¯ja targeting others to fill their nursing vacancies. and Kõlves explain how Managed Entry Agreements (MEAs) have been employed in Estonia, Latvia and Next, De Raeve and colleagues analyse whether Lithuania as one of a number of tools designed European enlargement provides an opportunity for to make new medicines available to patients, the nursing profession to gain traction on policy while at the same time safeguarding the financial change. They report on findings related to the sustainability of the health system. This is followed robustness of EU compliance mechanisms and the by an article critiquing the health system rankings of degree to which the nursing leadership is engaged the Health Consumer Powerhouse by Cylus et al. in agenda setting and policy-making. This section rounds off with an article by Keighley, who explores Our Monitor section features two new studies on how policy-making at the European level focused strengthening health system governance and on primarily on the free movement of professionals, making sense of European Union health law, while harmonisation of training, and mutual recognition of the normal round up of news brings you the latest education and training standards has resulted in a on health policy developments around Europe. largely unplanned new European framework for nurse education and training. The author notes that this We hope you enjoy the Spring issue! process has not always taken stock of the specific policy priorities of nurse representative groups. Sherry Merkur, Editor Anna Maresso, Editor In our International section, Edith Schippers, David McDaid, Editor Minister for Health, Welfare and Sport in the Netherlands, discusses the three health priorities for the 2016 Dutch presidency of the EU, all of which Cite this as: Eurohealth 2016; 22(1). EDITORS’ COMMENTEDITORS’

Eurohealth incorporating Euro Observer — Vol.22 | No.1 | 2016 Eurohealth OBSERVER 3

THE STATE OF NURSING IN THE EUROPEAN UNION

By: Britta Zander, Linda H. Aiken, Reinhard Busse, Anne Marie Rafferty, Walter Sermeus and Luk Bruyneel

Summary: The current European nursing workforce crisis is exacerbated by nursing shortages in most countries. Measures will need to be adopted to maintain a healthy and satisfied nurse workforce, to attract new nurses and to guarantee high quality care. The Registered Nurse Forecasting (RN4CAST) project aimed to study how features of work environments and nurse workforce qualifications impact on nurse and patient outcomes by confirming, in a large European setting, the core logic of previous US research. The results confirmed previous findings and highlighted the important role of nurses in providing safe patient care and pave the way for a renewed discussion on the direction of nursing’s future in Europe.

Keywords: Nurse Workforce Strategies, Nurse Work Environments, Nurse Education, Patient Safety, RN4CAST

Introduction and satisfied nurse workforce, to attract Acknowledgment: This research new nurses and to guarantee high Organisational features of nursing care, received funding from the European quality care. Union’s Seventh Framework from better patient-to-nurse staffing Programme (FP7/2007 – 2013, ratios to supportive work environments Grant Agreement No 223468). Until recently, the limited policy impact and better educated nurses, are associated of the existing evidence on the important with improved nurse wellbeing and better role of nurses in providing safe patient patient outcomes. In the United States, care was attributed to the evidence base Britta Zander is Research Fellow this evidence has emerged over the past being mainly from North America. and Reinhard Busse is Professor three decades through numerous research and Head of the Department of The first European study published programmes and has fuelled debates Health Care Management, Berlin in 2007 1 confirmed the US findings University of Technology, Germany; about the direction of nursing’s future. and was followed by a Belgian study Linda H. Aiken is Professor and Several high-profile policy and advocacy Director at the Center for Health in 2009. 2 Additionally, the Registered initiatives have been launched to achieve Outcomes and Policy Research, Nurse Forecasting (RN4CAST) study safe nurse staffing and improved work University of Pennsylvania, USA; was able to scale up evidence to a multi- Anne Marie Rafferty is Professor environments, such as mandated safe country context, confirming in a large at the Florence Nightingale nurse staffing ratios and the Magnet School of Nursing and Midwifery, European setting the core logic of previous Hospital Accreditation Programmes for King’s College, London, United US research. As a result, good nursing Kingdom; Walter Sermeus is excellence in nurse work environments. workforce strategies are now associated in Professor and Program Director In Europe, there is limited evidence of and Luk Bruyneel is a post-doctoral Europe with improved patient outcomes. a similar large-scale uptake of these researcher at the Leuven Institute Moreover, the RN4CAST findings have for Healthcare Policy, University of findings. Since nursing shortages threaten Leuven, Belgium. almost all European countries, measures Email: [email protected] need to be adopted to maintain a healthy

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paved the way for a renewed discussion Ireland, Poland, Spain and Switzerland). such intentions, about 9% (varied from 5% on the professional profile of nursing The patient survey included questions to 17% between countries) indicated that in Europe. about communication with nurses and the job they would seek would be outside doctors, responsiveness of hospital of nursing due to features of the work Research on nursing workforce staff, pain management, communication environment such as poor nurse-physician strategies in Europe about medicines, discharge information, relationships, leadership, participation in cleanliness and quietness of the hospital hospital affairs and burnout. 5 The RN4CAST study (2009 – 2011) environment, overall rating of the hospital aimed to study how features of work and willingness to recommend the hospital The number of patients per nurse during environments and nurse workforce to friends and family. Additionally, day-shifts estimated in the different qualifications impact on nurse retention, hospital discharge abstract datasets countries ranged from roughly four or job satisfaction and burnout among nurses were collected to calculate the impact five patients per nurse in Norway, the and on patient outcomes. Related to this of nursing care on patient outcomes. All Netherlands, Switzerland and Sweden to last measure, the study looked at how countries except Germany, Greece and nine or ten per nurse in Belgium, Greece, nurses could enhance the performance Poland had the required data available Poland, Germany and Spain. In fact, each of health care organisations and health in a format that allowed cross-country additional patient per nurse increased the itself. The consortium brought together comparisons. For the nine countries and likelihood of nurses reporting burnout, researchers from sixteen countries: the selected hospitals 3,987,469 patient job dissatisfaction and intention to leave twelve participating European countries records were collected using ICD-10 data within the next year. Supporting these (Belgium, England, Finland, Germany, in five countries and ICD-9-CM data in staffing ratios, the majority of nurses in Greece, Ireland, the Netherlands, Norway, four countries. most countries also reported that there Poland, Spain, Sweden and Switzerland), were not enough nurses or adequate three from outside Europe (China, support services to provide good patient Botswana and South Africa) while leading care. The effect of the work environment researchers from the US co-directed the was generally stronger than the specific consortium, providing guidance from staffing effect which emphasises the need study design to analysis. Drawing on 20 – 50% of to strengthen the work environments of previous experience of the ‘International nurses. In contrast, an important finding Hospital Outcome Study’, wherever nurses intended of the study was that almost every country possible, a pool of well-known and under study had one or more hospitals extensively-validated tools, supplemented to leave their that nurses ranked as having good work with recent measures that are important environments. However, hospital quality, to evaluate nurses’ roles in patient care current job safety and staff retention problems were were used. Details are described in depth common in all countries. 3 elsewhere but it is appropriate to provide Findings a short overview of the design to convey The role of nurses in providing safe the scale and scope of RN4CAST. The study results showed large differences patient care throughout Europe.‘‘* More than 25% ‘Nurses’ were defined in each country of nurses were dissatisfied with their The percentages of patients who gave high as those meeting the EU definition of job; however, dissatisfaction varied overall ratings to their hospital ranged trained and licensed nurses according to dramatically across the twelve European from 35% in Spain to close to 60% in Directive 2005/36/EC. The nurse survey countries and sources of dissatisfaction Switzerland, Finland and Ireland. Patients consisted of 118 questions, containing varied as well. No country was immune were less satisfied with their hospital stay the Practice Environment Scale of the from nurses’ negative work perceptions in those hospitals with worse nurse work Nursing Work Index (PES-NWI) and and 30% of nurses reported burnout. environments whereas patients in hospitals the Maslach Burnout Inventory (MBI) In spite of these seemingly high levels with better work environments were and included information on the quality of dissatisfaction and burnout, fewer more likely to rate their hospital highly of their work environment, burnout, than 1 in 4 nurses in all countries, and to recommend it. The same applied job satisfaction, quality of care, nurse except Greece (40%) and Ireland (28%), for patients in hospitals that had higher staffing levels and demographics. It was reported being dissatisfied with their percentages of burnt out or dissatisfied completed by 33,659 medical-surgical choice of nursing as a career. Nonetheless, nurses and more patients per nurse (that is, nurses working in 488 hospitals across the between 20 – 50% of nurses in every increased nurse workload). 6 twelve European countries. To measure country intended to leave their current job patient satisfaction and nursing related in the next year and of those that expressed Using data from 422,730 patients aged 50 experience with their hospital stay, patient or older who underwent common surgery experience data were obtained for 11,549 (orthopaedic surgery, vascular surgery, * An RN4CAST special issue published by the International patients in 217 hospitals in eight countries Journal of Nursing Studies in 2013 provided a descriptive report general surgery), it was demonstrated (Belgium, Finland, Germany, Greece, about the RN4CAST results and the state of hospital nursing that increasing a nurses’ workloads by practice in Europe (see Ref 4).

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one patient increased the likelihood of Summary and policy implications Two take home messages for policy- mortality by 7%. Furthermore, the results makers include: 1) significant The RN4CAST study generated a large suggested that having a better educated improvements in work environments can evidence base of nurse workforce issues nurse workforce (that is, every 10% be a relatively low cost lever and effective across European health systems, which increase in nurses with Bachelor degrees) approach to achieving the greatest value was unique regarding data on the number reduced the likelihood of mortality by 7%. for investments in nurse staffing because and qualifications of nursing staff, the These associations imply that patients it strengthens the nurse workforce through quality of working environments, burnout in hospitals in which 60% of nurses had better working conditions, which will rates, job satisfaction rates and intention- Bachelors degrees and nurses caring for attract new nurses and avoid high turnover to-leave rates. High variability in nurse an average of six patients would have rates; and 2) comprehensive planning and workforce issues was found across Europe. almost 30% lower mortality than patients forecasting methodologies are needed that In summary, RN4CAST strengthened the in hospitals in which only 30% of nurses account for increases in the dependency of belief that improvements can be made at had Bachelors degrees and nurses cared the population on the health system due to an incremental rate if policy-makers and for an average of eight patients. 7 demographic change. human resources managers acknowledge that nursing workforce strategies are EU policy makers can also look to Methodological progress modifiable properties of a health care findings from other recent European organisation in its mission to provide The RN4CAST study not only confirmed projects where RN4CAST has contributed, excellent patient care. The study followed- US findings, but also provided significant i.e. the Joint Action of Health Workforce up with a wide range of capacity building methodological progress. Several Planning and Forecasting (2013 – 2016)† and knowledge dissemination activities, RN4CAST studies analysed in detail the and a study on effective recruitment and providing resources to bolster future concept of missed nursing care, which retention for health workers (2014 – 2015).‡ health workforce strategies. pertains to omission of necessary nursing care. 8 9 The thinking was that missed In addition, the study conclusions nursing care reflects the process of care that nurse qualifications are related to and was defined as necessary nursing patient mortality can influence further activities that were missed due to lack decision making on the European nursing of time. Thirteen nursing care activities qualification structure which is positioning related to direct physical care and increasing a nurse education at the Bachelor degree monitoring, planning and documenting level (see also the article by Keighley on care and psychosocial care were defined. nurse’s workload nursing education in this issue). While Nurses were asked to indicate whether countries have made progress, there is still activities that were necessary were left by one patient great diversity and differences in the pace undone due to a lack of time during with which they have sought to transform their most recent shift. Across European increased the their nurse training systems from being hospitals, the most frequent nursing care vocationally-based to academically-based. activities left undone included ‘Comfort/ likelihood of Moreover, some countries lack clinical talk with patients’ (53%), ‘Developing career paths that are necessary to motivate or updating nursing care plans/care mortality by 7% advanced education (e.g. Sweden) while pathways’ (42%) and ‘Educating patients ‘‘ others do not differentiate between the The current European nursing workforce and families’ (41%). It was also shown roles of higher educated and intermediate crisis is exacerbated by nursing shortages that those tasks which were more likely to educated nurses in practice (e.g. the in most countries and by the increasing have negative consequences for patients Netherlands, Belgium). numbers of patients admitted to hospital. (e.g. pain management or medication on Measures will need to be adopted to time) were missed less frequently than Lastly, evidence on the variability of maintain a healthy and satisfied nurse those tasks with less immediate or direct patient-to-nurse ratios in European workforce, to attract new generations of effects (e.g. psycho-social). Furthermore, hospitals has created momentum in several nurses, to sustain the workforce of nurses the results showed that less care was national policies not to lower their nurse wishing to retire early or remain longer omitted in hospitals with more favourable staffing ratios in times of austerity. In in the job and to have nurses working work environments, lower patient to nurse England, safe nurse staffing ratios in part-time due to dissatisfaction return ratios and lower proportions of nurses adult patient wards in acute hospitals to full-time status. These measures go carrying out non nursing tasks frequently. have been recommended by the National beyond only increasing staffing levels. In addition, it was shown that the effect Levers for improving the quality of of poorer nurse staffing on more care left patient care include investing in a better undone diminishes with an increasing educated nurse workforce and improving proportion of university-educated nurses. 10 work environments. † http://healthworkforce.eu/

‡ http://ec.europa.eu/health/workforce/policy/recruitment/ index_en.htm

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Institute for Health and Care Excellence workforce strategies as well as to allow 4 Aiken LH, Sloane DM, Bruyneel L, Van den (NICE) since July 2014, partly based on the building of a business case, because Heede K, Sermeus W, RN4CAST Consortium. Nurses’ RN4CAST evidence. European evidence on the economic value reports of working conditions and hospital quality of care in 12 countries in Europe. International Journal of nursing remains scarce. of Nursing Studies 2013;50(2):143 – 53.

5 Heinen MM, van Achterberg T, Schwendimann R, Further reading et al. Nurses’ intention to leave their profession: a cross sectional observational study in 10 European A comprehensive overview of nurses’ countries. International Journal of Nursing Studies European situations in fourteen European countries 2013;50(2):174 – 84. (the original twelve RN4CAST countries 6 Aiken LH, Sermeus W, Van den Heede K, et al. evidence on the plus Lithuania and Slovenia) is due to be Patient safety, satisfaction and quality of hospital published in autumn 2016. 11 The book care: cross sectional surveys of nurses and patients economic value will place the RN4CAST findings into in 12 countries in Europe and the United States. context by elaborating for each country the British Medical Journal 2012;344:e1717. of nursing organisation of the health system, nurse 7 Aiken LH, Sloane DM, Bruyneel L, et al. Nurse education and regulation, the structure staffing and education and hospital mortality in nine remains scarce of nurses‘ work and the composition, European countries: a retrospective observational study. The Lancet 2014;383(9931):1824 – 30. deployment, career structure, planning 8 Ball J, Murrells T, Rafferty AM, Morrow E, Strengthening health systems mechanisms, as well as mobility of nurses. Further, thematic chapters will focus Griffiths P. “Care left undone” during nursing shifts: through nursing‘‘ associations with workload and perceived quality of on the contribution of nursing to health care. BMJ Quality and Safety 2014;23(2):116 – 25. The work of the consortium continues care systems, nurse education, workforce 9 to gather momentum. Some other planning, migration, and regulation. Ausserhofer D, Zander B, Busse R, et al. Prevalence, patterns and predictors of nursing care countries are replicating the RN4CAST left undone in European hospitals: results from the study (Portugal in 2013; Cyprus and References multicountry cross-sectional RN4CAST study. BMJ Italy, currently underway). The US, Quality and Safety 2013 Nov 10. 1 Rafferty AM, Clarke SP, Coles J, et al. Outcomes Germany and Belgium are collecting data 10 Bruyneel L, Li B, Ausserhofer D, et al. Organization of variation in hospital nurse staffing in English in 2015/2016 to provide a longitudinal of hospital nursing, provision of nursing care and hospitals: cross-sectional analysis of survey data and patient experiences with care in Europe. Medical Care perspective. Thus, the work of RN4CAST discharge records. International Journal of Nursing Research Review 2015; 72(6):643 – 64. continues with the common objectives of Studies 2007;44(2):175 – 82. 11 highlighting the importance of nursing in 2 Rafferty AM, Busse R, Zander B, Bruyneel L, Van den Heede K, Lesaffre E, Diya L, et al. Sermeus W. The contribution of nursing to heath improving patient outcomes and promoting The relationship between inpatient cardiac surgery system performance: A European perspective. and improving the situations for nurses mortality and nurse numbers and educational level: Copenhagen: European Observatory on Health in their countries. Future initiatives will analysis of administrative data. International Journal Systems and Policies, 2016 Forthcoming. aim to model the complexity of nursing of Nursing Studies 2009;46(6):796 – 803. workforce strategies in an intervention 3 Sermeus W, Aiken LH, Van den Heede K, et al. in order to assess the optimum level of Nurse forecasting in Europe (RN4CAST): Rationale, production. Such initiatives are expected design and methodology. BMC Nursing 2011;10:6. to provide more steering in developing

United Kingdom: services function remarkably well overall. Many health outcome measures, such as amenable mortality, have improved in Health system review recent years due in part to public health initiatives and a general emphasis on improving the quality of care. However, By: J Cylus, E Richardson, L Findley, M Longley, C O’Neill the marked reductions to health and D Steel and social care budgets since the financial crisis call into question Copenhagen: World Health Organization 2015 (acting as whether the United Kingdom the host organization for, and secretariat of, the European can continue this progress. As it Observatory on Health Systems and Policies). stands, health inequalities remain Number of pages: xxvii + 125 pages; ISSN: 1817-6127 and the gap between the most deprived and the most privileged Freely available for download at: http://www.euro.who. continues to widen, rather than int/__data/assets/pdf_file/0006/302001/UK-HiT.pdf?ua=1 close, despite universal access that is mostly free at the point The United Kingdom spends less on health compared to many of use. other Western European countries, yet the national health

Eurohealth incorporating Euro Observer — Vol.22 | No.1 | 2016 Eurohealth OBSERVER 7

NURSE MIGRATION IN THE EU: A MOVING TARGET?

By: Claudia Leone, Ruth Young, Diana Ognyanova, Anne Marie Rafferty, Janet E. Anderson and Gilles Dussault

Summary: The nursing profession is the most numerous and increasingly mobile element of the health workforce. Imbalances of nurse supply and demand across the EU/EEA are generating challenges for policy-makers and managers. Increasing mobility within the EU/EEA has been caused by countries targeting others within the region to fill nursing vacancy posts, although the number of nurses is finite. Data from two studies on migration to the English National Health Service are analysed to provoke a more informed debate on the increasing complexity of migration in the current EU/EEA agenda and the possible consequences for the supply of the nursing workforce.

Keywords: Nurses, Nurse Shortages, EU/EEA mobility, Portugal, England

Introduction workforce planners. In contrast to non-EU flows, which can be controlled A message consistently emerging from through immigration regulations, there the literature on health systems is their are no formal monitoring mechanisms Acknowledgement: The study increasing vulnerability to workforce between EU/EEA countries and very upon which this article is based fluctuations. 1 Mobility is one factor with draws from a study funded by few certainties regarding the pattern, the potential not only to determine how The Foundation for Science and destination and length of stay for Technology, UK PhD Grant SFRH / health services are organised, planned EU nationals. BD /94301 / 2013. and delivered within a health system, but also to generate imbalances in supply and In England, recent reports confirm that demand from region to region. 2 3 This the nursing shortage persists across is particularly the case in the European Claudia Leone is a PhD candidate, the whole country, across all types of Union and European Economic Area Ruth Young is Reader in Health health care organisations and all areas of Policy Evaluation, Anne Marie (EU/EEA), where mobility is facilitated by practice, 6 leading most National Health Rafferty is Professor and Janet E. the principle of freedom of movement. Anderson is Senior Lecturer at Service (NHS) organisations to become the Florence Nightingale Faculty increasingly active in recruiting nurses of Nursing and Midwifery, King’s The nursing profession is the most College, London, United Kingdom; in other EU countries, such as Portugal, numerous, and increasingly mobile, 6 Diana Ognyanova was Research to fill vacancies. In what follows, we element of the health workforce. 4 Fellow at the Department of Health attempt to provoke a more informed debate Recognition of this for the quality and Care Management, Berlin University on the need to recognise the increasing of Technology, Germany at the effectiveness of care is gaining increasing complexity of factors affecting migration time of writing this article; and traction with policy-makers and managers. Gilles Dussault is Professor of in the current EU/EEA agenda and the Cross-border migration within the EU/ International Public Health and possible consequences, intended and Biostatistics at the Institute of EEA is seen as having a significant unintended, for the supply of the nursing Hygiene and Tropical Medicine, but largely unmeasured effect. 5 The Nova University of Lisbon, Portugal. workforce. We use material from two real challenge posed by increasing Email: [email protected] European studies: data from Portugal mobility is the implications it has for

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newly added to the RN4CAST dataset 2 address current vacancies and projected focused recruitment flows, there is little and the PROMeTHEUS series, 5 7 8 from severe shortages. However, all these empirical research on the impact of these which data are being gathered in a book responses either promise results in the flows on health care organisation, and on nursing from the EU Observatory on long term (e.g. the results of increasing more importantly, on their duration, to Health Systems and Policies. 9 training places will be visible from 2020 inform workforce planners. According to onwards 6 ) or rely on strategies that have many organisations, throughout 2014 – 15 Firstly, we map the current nursing no assurance of being more than just a the pool of available nurses (potential shortage and the most common policy temporary stop-gap to manage shortages. new recruits) from within the EU/EEA responses in England. Second, we As NHS organisations are in urgent need was found to be smaller than in previous present data that show the changing of a larger pool of nurses, many have years. 6 As vacancy rates spread, more and complex nature of mobility trends. become more active in recruiting nurses in organisations (and countries) are led Third, we emphasise the impact on EU/EEA countries. 6 to join the search for nurses through Portuguese nurses. Finally, we consider European recruitment drives. However, the the implications for sending and Changing patterns of mobility stock of nurses from EU/EEA countries is receiving countries. finite, 6 and the number of recruiters has International practices in England have been growing. National shortages included specially-arranged recruitment fairs in several countries. Until a few Many factors may account for the England, as a traditional destination for years ago, the most common destinations changing patterns of migration trends. 5 7 health professionals from inside and were the Philippines and India. 5 7 But in First, EU nurses are exercising their rights outside the EU, 5 can showcase the ongoing recent years, large pools of low-paid and of free movement underpinned by shifts in mobility patterns within the EU/ unemployed nurses in EU/EEA countries Directive 2005/36/EC and its updated EEA. Like many other industrialised which were most severely affected by the version in 2013 (2013/55/EU 11 ) on the countries in the region, England has economic crisis, such as Portugal, Spain recognition of professional qualifications. remained an attractive option for nurses and Italy, have been serving as the target Second, changes in policies regarding looking for work opportunities abroad. for many trusts in need of skilled nurses. immigration and professional registration PROMeTHEUS and earlier studies 5 7 Registration data showed that in 2014 – 15, have a clear impact on the number of suggest that the most attractive “pull” a total of 8,183 internationally recruited professionals from non-EU countries. factors are: the greater opportunities nurses joined the Nursing & Midwifery Such changes include monthly limits for professional development through Council (NMC) register to work in the on secured restricted certificates of postgraduate education available in UK; 7,518 (92%) from within the EU/EEA sponsorships (RCoS) and the decision to the UK; the English language; and and 665 (8%) from outside the EU/EEA. 10 exclude or include nursing in the Shortage geographical proximity to the rest Recent policy reports also found that 93 Occupation List (SOL). Following the of Europe. NHS Trusts (63% of all respondents in decision to first exclude nursing from the a survey) have actively recruited from SOL in early 2015, many organisations However, despite the increasing flows of outside of the UK in the last 12 months: were unable to secure RCoS for nurses foreign nurses, there is evidence that poor 62% of these have targeted recruitment from out of the EU/EEA, slowing down staffing levels and vacancy rates in the activity only in EU/EEA countries their recruitment. 6 Since December 2015 NHS are a persistent problem. There are during the same period, mainly in Italy, (and at least until planned a review in no official figures on how many nurses the Spain and Portugal. 6 Data specifically spring 2016), nursing is back in the SOL, system is currently short of, but according about Portugal, 2 showed that the number which seems likely to impact on the to recent data from an NHS Trusts survey, of Portuguese nurses registered with directional flow of recruits from non EU/ national vacancy rates run at 10%. Ninety the NMC increased from 250 to 1,211 EEA countries once again. Finally, recent three percent of Trusts are reporting from 2010 to 2013, which represents amendments to the 2005/36/EC Directive shortages, of which 72% are hard-to-fill an estimated five-fold increase. Early on professional qualifications, such as vacancies (i.e. vacant for more than three findings of ongoing research* suggest that the agreement to introduce language months). 6 Overall, the current situation is Portugal became the second biggest source competency controls for professions, has one of a national nursing shortage. of recently recruited foreign nurses after consequences for patient safety and needs Spain in the same time period. to be considered as well. 11 The impact Concerns about the consequences of of these language checks remains to be these vacancy rates have been mounting, But the mobility of health professionals seen but it is likely to further reduce the particularly since the effects on quality of has always had a dynamic and changing pool of EU/EEA nurses, as has been the services and on mortality rates have been nature, particularly evident in periods of case for the medical profession when the highlighted. 2 Organisational and policy major economic or geopolitical change. 5 General Medical Council introduced this responses, such as using agency/temporary Despite the reliance on these EU/EEA requirement in 2014. 6 nurses, return-to-practice campaigns and

increased adult nurse training numbers, * This article outlines part of the background of an ongoing have been put in place in an attempt to PhD study on the implication of EU-nurse (Portuguese) Recruitment for NHS organisations in England.

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Tension between national interests but unable to find employment, as their be possible only through closer policy and EU policy national health systems are unable to articulation between organisations, and absorb them. 5 This is not due to lack of national and European authorities. According to EU regulations, it is the need but due to lack of funds and/or sector responsibility of individual countries to reform restrictions. In other countries such decide how their services are delivered, Conclusions as England and Germany, organisations how treatment or care is paid for, and, have unfilled posts and are willing to pay Nurses will not stop moving to, from, most importantly for us here, how or which high rates for temporary nurses, assuming and within Europe. However, in the health staff are trained and deployed, also recruitment and travel costs to attract current context, the scale and impact where and in what numbers. This is professionals from abroad. on the workforce and on health systems defined by the principle of subsidiarity of are raising concerns. Policy-makers and the EU. 11 However, since free movement One way of starting to tackle these labour managers need to respond both within is a reality, it has become obvious that market deficiencies is to recognise and particular countries and at the EU/EEA health services and the development of document the complexity of factors level. Countries receiving health workers the health care workforce within Member influencing migration. Those which, from abroad need to work towards States cannot be understood without on balance, are losing their nurses to achieving greater self-sufficiency while also considering the broader EU-level other countries need to understand what also helping professional and employer legislative changes that are being driven by measures they can implement to keep more organisations to provide migrants with economic and geopolitical factors. 7 health workers at home and/or encourage support to integrate them effectively into and benefit from return migration. Data the workforce. Those losing their nurses Drivers of health workforce shortages, from PROMeTHEUS, RN4CAST, 2 8 and to other countries need to understand such as demographic changes in the more recently from an EU commissioned what measures they can take to avoid population and in the health professions, Recruitment and Retention study, 7 help to uncontrolled and undesired outflows and and increasing demand for care have been address that information gap by exploring how to benefit from return migration. 6 abundantly reported. 3 5 Yet, shortages are the importance of workforce management also generated by policies and austerity and working environments for nurse The focus of most of this will have to measures at the national 6 and European retention. PROMeTHEUS studies 5 showed be on the interaction between policy levels. Both have influences that may that relying on the expectation that nurses and organisational levels and on the limit recruitment, replacement and gain additional skills, competencies and workplace itself. It is important not only to retention to meet savings and to address experiences abroad to be applied back maximise the contribution of these highly particular concerns around mobility when they return is short sighted. In qualified professionals to either sending (e.g. language competency). practice, experience in another European or receiving health systems, but also to country may not always be seen as reinforce one of the founding principle From this, what is clear is that EU/EEA compatible or even relevant to a nurse’s of the EU/EEA, which is for individuals recruitment is not a strategy that can be home country. 5 This might explain why to deploy their skills and qualifications considered reliable or sufficient on its own these studies found that nurses stay in where they choose. Data from recent to address workforce problems. Even if it their new country much longer than they studies are already sufficient to provoke serves the national interests of receiving expected, and some permanently. a more informed debate about the need to countries, such as England, it is unlikely recognise the increasing complexity and to solve skill shortages as it does not For those on the receiving end, the logical tension between national interests and EU focus on the issues that led to the present solution would be to move to a position of policies in the current EU/EEA agenda situation. It also fails to foster the principle greater self-sufficiency. They could also and the possible intended and unintended of solidarity and cooperation between EU/ do more to engage with sender countries consequences on workforce planning and EEA countries, as the pulling power of to encourage and facilitate re-integration management of the nursing workforce some countries may weaken the possibility for returners. Bilateral agreements, across Europe. of others to retain their remaining institutional collaborations and exchange workforce. 5 7 programmes are some examples of options References proposed in the literature. 5 Towards more helpful debates 1 Glinos IA. Health professional mobility in the Overall, the primary aim has to be European Union: Exploring the equity and efficiency Mobility patterns between Portugal of free movement. Health Policy 2015;119:1529 – 36. to ensure that the individual patient and England are relevant to the 2 experience is safe and of high quality. But Leone C, Bruyneel L, Anderson JE, et al. broader EU situation on account of the health providers also need to be assisted Work environment issues and intention-to-leave characteristics they share with other in Portuguese nurses: A cross-sectional study. to obtain maximum value from employing sending and receiving countries in the Health Policy 2015;119:1584 – 92. EU/EEA nurses and nurses themselves region. Countries such as Portugal, but 3 need to be empowered and assisted to Kreutzen M, Dussault G, Craveiro I, et al. also Spain and Italy, have well-educated, Recruitment and retention of health professionals gain the maximum benefits from moving newly-qualified and experienced nurses across Europe: A literature review and multiple case to another EU/EEA country. 7 This will motivated to work within their profession study research. Health Policy 2015;119: 1517 – 28.

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4 Kingma M. Nurses on the move: migration and the EU ACCESSION: global health care economy. NY: Cornell University Press: Ithaca, 2006. 5 Buchan J, Wismar M, Glinos IA, Bremner J (eds). A POLICY WINDOW Health professional mobility in a changing Europe New dynamics, mobile individuals and diverse responses. Copenhagen: WHO Regional Office for Europe on behalf of the European Observatory on Health FOR NURSING? Systems and Policies, 2014. Available at: http://www. euro.who.int/__data/assets/pdf_file/0006/248343/ Health-Professional-Mobility-in-a-Changing-Europe. pdf

6 NHS Employers. NHS registered nurse supply By: Paul De Raeve, Anne Marie Rafferty and Louise Barriball and demand survey – findings, 2015. Available at: http://www.nhsemployers.org/ case-studies-and-resources/2016/01/2015-nhs- registered-nurse-supply-and-demand-survey- findings Summary: European enlargement provides an opportunity for the 7 Young R, Weir H, Buchan J. Health professional mobility in Europe and the UK: a scoping study of nursing profession to gain traction on policy change but our research issues and evidence. Research Report produced for the National Institute for Health Research Service demonstrates that the European Commission mechanisms to process Delivery and Organisation Programme, 2010. compliance need to be robust and designed to deliver such change. 8 Zander B, Blumel M, Busse R. Nurse migration in Europe – Can expectations really be met? These opportunities also increase when the nursing leadership Combining qualitative and quantitative data from Germany and eight of its destination and source operates across a united front and articulates its agenda with a clear countries. International Journal of Nursing Studies political voice. In addition to a united leadership, we argue that nursing 2013;50(2):210 – 8.

9 Rafferty AM, Busse R, Zander B, Bruyneel L, needs support from civil servants and EU officials so that it can Sermeus W. The contribution of nursing to heath influence the EU accession policy agenda relating to nursing and system performance: A European perspective. Copenhagen: European Observatory on Health shape successful policy outcomes. Systems and Policies, 2016. Forthcoming.

10 The Royal College of Nursing (RCN) 2015 International Recruitment 2015. The Royal College Keywords: Acquis Communautaire, EU Accession, Nursing Leadership, Stakeholder of Nursing, London. Available at: https://www2. Engagement, Taiex, Health Policy rcn.org.uk/__data/assets/pdf_file/0007/629530/ International-Recruitment-2015.pdf

11 European Commission. Modernisation of the Introduction practice. 2 In addition to these political Professional Qualifications Directive – frequently requirements, membership of the Union European enlargement has been the asked questions. Brussels: Commission for the requires a functioning market economy European Communities, 2013. subject of extensive investigation in a and the capacity to cope with competitive Available at: http://europa.eu/rapid/press-release_ wide range of policy areas. 1 However pressures and market forces within MEMO-13-867_en.htm the impact of European Union (EU) the Union. 3 enlargement upon one of the largest health professions, nurses, has been largely neglected in health policy research. Acquis Communautaire European institutions are currently The EU accession process consists halting EU enlargement although there of negotiations between national are Commission negotiations and governments and the European preparations with five candidate countries: Commission with the aim of aligning Albania, the former Yugoslav Republic national legislation with the European Paul De Raeve is King’s College of Macedonia, Montenegro, Serbia Directives set out in the Acquis London PhD and Secretary General and Turkey, Bosnia and Herzegovina, of the European Federation of Communautaire. The Acquis comprises Kosovo, Georgia and Ukraine are Nurses Associations (EFN); Anne several chapters reflecting the broad Marie Rafferty is Professor of potential candidates. Becoming an EU sectors of EU responsibility, including Nursing Policy, Louise Barriball is Member State entails working towards Professor of Healthcare Education, Chapter 3, incorporating the free movement a well-functioning democracy with Florence Nightingale Faculty of of “nurses responsible for general stable institutions and the rule of law Nursing and Midwifery, King’s care” (Directive 2005/36/EC, recently College London, United Kingdom. being guaranteed, with human rights modernised by Directive 2013/55/EU). Email: [email protected] and the protection of minorities being This Directive includes the recognition of legally guaranteed and respected in

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professional nursing qualifications, and at the time of the study – and the different an ethnographic, multi-method design transposing the minimum requirements levels of development of nursing as involving qualitative interview and of the Directive relating to the minimum a profession. documentary analysis, exploring the entry level of general education; the full mechanisms used by the Commission educational programme of 4600 hours; Nursing after Ceausescu and Tito to process compliance and the degree to a minimum one third of the educational which the nursing leadership was able programme being theoretical and at The starting point at which the Romanian to capitalise upon the opportunity to least 50% being spent on clinical training and Croatian nurse leaders entered EU formulate and implement a professional on a full-time basis. Most importantly, accession differed from economic and agenda and achieve policy goals in new Article 31, sets out eight competencies political perspectives. While Croatian both cases. 7 and makes it clear who is a general care nurse leaders lived through a well- nurse according to EU Legislation. As functioning free market economy but the nursing profession is one of the most had to endure a terrible Balkan War, mobile professions in the EU, compliance the Romanian nursing leadership found one of with the European Directive on Mutual itself in a collapsed economy, inefficient Recognition of Professional Qualifications state institutions, a highly politicised the most mobile (MRPQ) is key for patient safety and and unaccountable judiciary and public quality of care 4 5 and protecting the administration, corruption, political professions in individual nurse willing to move within apathy and mistrust. Although Romania the EU. and Croatia differed on the political the EU and economic EU membership criteria, TAIEX the status of nursing education post- Findings communism was quite similar: nursing The compliance policy process for EU education at the secondary level was The findings relate to the robustness of membership is supported by the European located within vocational and technical the EU compliance mechanisms and the Commission’s Technical Assistance and schools and as such, ‘nurses’ were called degree to which the nursing leadership Information Exchange (TAIEX) peer medical assistants. engaged‘‘ in agenda setting and policy- reviews and capacity building seminars. making. Three policy mechanisms Taiex is the instrument responsible for all Romania and Croatia both share the were identified which were used to technical assistance elements in relation legacy of a Soviet-influenced health care reach compliance with the Acquis: the to preparations for the application of system, based on the hospital-focused Commission’s comprehensive monitoring the Acquis. Peer reviews are the main Soviet Semashko model, including reports, the Taiex peer review reports, mechanism for determining whether informal payments. 6 Moreover, the and the Taiex capacity-building seminars. adequate administrative infrastructure nursing profession in both cases shared Findings suggest that these three policy and capacity are in place to ensure full similar conditions and mind-sets from mechanisms were not robust enough to implementation of the Acquis and they the post-communist conservative regime deliver successful legislative outcomes, also pinpoint areas that require further ensuring that nursing education continues although the comparison of Romania and strengthening. The Taiex capacity- to be medically dominated. This position Croatia showed that the Taiex capacity- building seminars are therefore largely was exacerbated by the perception of building seminars enabled the nurse demand driven, facilitating the delivery policy-makers that it was not necessary leadership to influence the process to of appropriate tailor-made expertise. to develop the nursing profession and gain capacity building funds in the The peer review reports tend to be an health care system by transitioning to case of Croatia to put a plan in place to important source of information for the higher education. The contextualisation of upgrade nursing education. Nevertheless, Commission’s comprehensive monitoring Romanian and Croatian nursing education findings indicate that the Taiex peer reports upon which political leaders from history within the wider political review and capacity building mechanisms the European Commission, the European and policy context indicates that the were too weak for the recommendations Council and the European Parliament minimum requirements, as set out in the to be picked up by the Commission’s make informed decisions on progress Directive 2005/36/EC, were not met prior comprehensive monitoring reports, signed towards compliance with the Acquis. to EU accession. off by politicians in the three European Institutions: European Commission, Lessons can be learned from the Case studies European Parliament and Council Romanian and Croatian EU accession of Ministers. process. The main criteria for selecting We explored two case studies, Romania Romania and Croatia relate to their and Croatia, of nurse leadership Commission Comprehensive historical and political contexts, their engagement in the EU accession policy- Monitoring Reports different positions within the EU accession making process and the extent to Based on the study findings, it transpired process – especially timing and the stage which EU accession provided a policy that compliance with Directive 2005/36/ reached in the overall accession process window to advance a professional EC was not a major priority for agenda. A comparative two – stage case governments, further weakening the study approach was adopted within Eurohealth incorporating Euro Observer — Vol.22 | No.1 | 2016 12 Eurohealth OBSERVER

capacity of the Commission’s Although the Taiex recommendations recommendations up the political agenda comprehensive monitoring reports in could have a political impact on the itself was reliant on the goodwill of EU accession negotiations to upgrade negotiations, government reluctance to civil servants negotiating EU accession nursing education. The case study acknowledge non-compliance with the itself. Therefore, the imperative to drive findings show that the comprehensive EU Directive 36/55 criteria impacted the process through may have militated monitoring reports failed to ensure that negatively on the development of the against the nascent nurse leadership being recommendations for compliance were nursing profession in both cases. able to influence the uptake of the Taiex carried through to align with legislative peer review recommendations and the change. Non-implementation was not an Consequently, nurses in Romania and capacity building seminars. Furthermore, impediment to closing chapters of the Croatia are still called medical assistants ministries did not seize the opportunity Acquis and therefore no sanctions were (not nurses) and therefore face problems to upgrade the nursing workforce. Indeed, applied. As such, it can be argued that the accessing free movement in the EU there are signs of a residual intention to Commission’s comprehensive monitoring based on MRPQ. 8 These challenges have block free movement by some ministries reports were not well designed for multi- remained unresolved as the Romanian in order to retain the nursing workforce level governance and, consequently, are and Croatian national governments see which otherwise would migrate as a not sufficiently robust to respond to the the Acquis as a potential exit route for consequence of Directive 2005/36/EC nursing education challenges prior to nurses lured by better working conditions (DIR 2013/55/EU). EU accession. in other EU Member States. Both governments agreed with the Commission Unified voice in agenda-setting that they would install a new nursing It can therefore be argued that EU education curriculum at university level compliance mechanisms were unable in compliance with Directive 2005/36/ EU to provide the necessary traction to EC, from the date of entering the EU, move from legislative endorsement leaving the existing secondary school level compliance to legislative implementation through nursing workforce in non-compliance. lack of governmental commitment and It can be argued that this represents a mechanisms stakeholder engagement. 9 However, missed opportunity for a predominantly although these mechanisms acted as female profession to develop their skills were unable a barrier to effective compliance, the and competencies and hence promote leadership of the nursing community (e.g. their ability to move within the EU provide traction professional association, nursing regulator, on the basis of MRPQ. Romanian and nursing union, chief nursing officer) Government’s lack of preparation Croatian nurses will move in the EU, but were not mobilised to work together or not as nurses benefiting from the mutual Similarly, although the Taiex peer provide a united voice in agenda-setting recognition regime, potentially impacting review reports pinpoint areas requiring or framing professional and legislative negatively on the national and European further attention,‘‘ the recommendations outcomes. With respect to the leadership workforce composition. do not tend to be an important source needed to engage in the EU accession of information for the Commission’s policy process, the evidence suggests that Capacity building comprehensive monitoring reports. the nursing leadership was imbued with These reports are important since they Finally, the third mechanism, the Taiex the culture of the Communist regime form the basis upon which EU political capacity building seminars, addressing in which nurse leaders’ interests, their leaders make informed decisions. As the weaknesses set out in the peer review patterns of interactions and subordinate both cases show, Chapter 3 of the Acquis reports, can be extremely helpful in roles in policy design set the level of was provisionally closed, although bringing stakeholders together, facilitating compliance with Directive 2005/36/ there was no evidence of the Taiex a better understanding of how to transpose EC (DIR 2013/55/EU). Consequently, recommendations having been addressed Directive 55 into national legislation and a persisting cultural legacy maintains adequately. Rather, the Taiex peer review how to address the challenges set out in nursing education at the secondary level. reports were treated as a negotiation the Taiex peer review reports. However, Nevertheless, a strong strand of opinion tool between the government and the requesting funds from the EU for nursing supporting the development of nursing as Commission, with minor engagement implied admitting there was a problem a profession at university level is emerging of stakeholders and specifically, no to be fixed. This failure to demand EU and growing, with the potential to consign engagement with the nursing leadership financial support seems to have missed vocational training to the past. in formulating solutions to address the a major policy window opportunity to Taiex recommendations. The weaknesses bring together relevant stakeholders to Medical-dominated Soviet Semashko in nursing education identified in the design new national nursing legislation model Taiex peer review reports were not in compliance with the European Findings suggest that the nursing addressed due to the government’s lack of Directive. The nursing leadership was profession’s overall capacity to influence readiness and attitude towards upgrading severely constrained in raising agreed the policy process was weakened by nursing workforce competencies challenges to their ministry officials challenges in harnessing a unified towards EU standards (Directive 55). since they recognised that moving Taiex

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and coordinated position in relation professional outcomes at national level in 5 Keighley T. European Union standards for nursing to influencing the political agenda. compliance with EU nursing education and midwifery: Information for accession countries. Conflicting agendas between nursing standards relates to inherited policy; Copenhagen: WHO Regional Office for Europe, 2009. leaders left leverage for politicians the political context of the Communist 6 Gaal P, McKee M. Informal Payment for pursuing their own agendas and regime; the weakness of the Commission’s Health Care and the Theory of INXIT. International responsibility for acceptance of the mechanism to achieve compliance; and Journal of Health Planning and Management 2004;19(2):163 – 78. legislative and professional outcomes the lack of unity within the nursing in the hands of civil servants, mainly leadership community in setting a joint 7 Baillie L. Ethnography and nursing research: a physicians and lawyers. It is equally professional agenda. It is clear that the critical appraisal. Nurse Researcher 1995;3(2), 5 – 21. possible that nurse leaders were process itself, in its initial phase, militated 8 Maciejewski M. Freedom of Establishment, marginalised from the process since they against engagement for a complex mix of Freedom to Provide Services, and Mutual Recognition had little track record of operating within reasons. Therefore, it can be argued that of Diplomas, European Parliament, 2012. the complex politico-legal environment of EU accession was an important starting 9 Fagan A, Sircar I. Compliance without governance: the EU. The nursing leadership’s divided point for stimulating nursing leadership the role of NGOs in environmental impact assessment positions seemed to undermine nursing advocacy work in Eastern European processes in Bosnia-Herzegovina. Environmental Politics 2010;19(2). leaders in seizing EU accession as an countries, such as Romania and Croatia, opportunity to move nursing towards a and for providing some exposure to the 10 Weston MJ. Strategies for Enhancing Autonomy position of being part of the European mechanisms of process compliance. and Control Over Nursing Practice. OJIN: The Online Journal of Issues in Nursing 2010;15 (1):2. Single Market, benefiting from free However, the Comprehensive Monitoring movement. Nursing is the most mobile and Taiex peer review were weak levers to 11 Aiken LH, Clark SP, Sloane DM, et al. Effects of profession and each nurse in principle hold back EU membership when targets hospital care environment on patient mortality and nurse outcomes. Journal of Nursing Administration should be able to benefit from the unique were not met. The Taiex capacity building 2008;38:223 – 29. mutual recognition regime in the EU. seminars, if properly used, could be a 12 tool to build the capacity of the nursing Underdal A. Strategies in international regime negotiations: reflecting background conditions or Credentialing rivalry leadership to design an advocacy strategy shaping outcomes? International Environmental to address critical gaps in the future. Finally, evidence suggests there was Agreements 2012;12(2):129 – 44. rivalry between the respective ministries Finally, the findings form part of the wider of education and of health in which argument that nurses need to increase their International Summer School newly created agencies, governmental engagement in multi-level governance and on Integrated Care – “Integrated Care departments and committees fragmented political decision-making processes at all in Theory and Practice”, 26 June – 1 July the mutual recognition credentialing levels of the policy system. 10 11 The study 2016 at Wolfson College, University of process. Rivalry over responsibility for findings provide evidence that the lack of Oxford, United Kingdom the recognition of credentials between the multi-level and lateral governance 12 – as ministries reflected the tensions within Organised by the International Foundation a system involving different institutions the nursing community, each trying to for Integrated Care (IFIC) this week- and stakeholders with diverging views maintain their own influence and control long course of intensive training on and perceptions – impacts negatively both over the recognition of professional the theory and practice of integrated on the policy process and the outcomes qualifications, thereby constraining the care is aimed at health and social care achieved. Leadership becomes the key future professional development of the professionals, clinicians, researchers and driver for successful policy outcomes largest occupation in the health sector. It managers who want to strengthen their but needs to be harnessed according to a can be argued that the power differentials understanding of integrated care and be coherent strategy designed to modernise and rivalries between ministries as well part of the development of an international EU accession mechanisms and align that as the structure of the nursing leadership community of practice on integration leadership to achieving policy consensus weakened the nursing advocacy efforts sharing knowledge and experiences from between the key state and non-state actors. and helped to explain why the nursing around the world. The course will provide leadership was unable to capitalise upon a comprehensive overview of the principles, the EU accession policy window. References models and building blocks of integrated

1 care – and illustrate pitfalls, lessons learned Börzel TA. Policy Change in the EU’s Immediate Conclusions Neighbourhood. A Comparison in Practice, co-edited and success stories of integrated care with Katrin Böttger. Baden-Baden: Nomos, 2012. initiatives by discussing and contextualising

2 cases from many countries. Based on the above findings, it can Morlino L, Sadurski W. Democratisation and the be concluded that EU accession was European Union. Comparing Central and Eastern Deadline for applications: 18 March not a destination but rather a starting European post-communist countries. London: point for nursing education to comply Routledge, 2010. If you are interested or know colleagues who are, please visit: with European standards as set out in 3 Hillion C. EU Enlargement. In Evolution of EU Directive 2005/36/EC (DIR 2013/55/ Enlargement Policy. Academia, 2011: 188. http://integratedcarefoundation.org/events/ international-summer-school-integrated- EU). The failure of the nursing leadership 4 De Raeve P. Nurses’ Voice in the EU Policy care-issic to achieve successful legislative and Process. Kluwer, 2011.

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IS THERE AN EU FRAMEWORK FOR NURSE EDUCATION?

By: Tom Keighley

Summary: This article explores the unplanned way in which a framework for nurse education has emerged within the European Union. Using the reform of Directive 2005/36/EU and its subsequent amendment (2013/55/EU) as the lens for this exercise, certain issues worthy of further examination emerge. Among them are the likely impact of the Professional Card, a competency-based EU-wide nurse education programme, and what the mechanisms will be for exercising the delegated acts. The article concludes with observations about current policy making and its implications both for Member States and accession countries.

Keywords: Nurse Education, Nurse Qualifications, Mutual Recognition, Free Movement, EU Policy

Introduction care delivery. The picture, therefore, is of a complex matrix of influences The immediate answer to the question all impacting on nurse education and in the title is no, as there is no European practice while focusing on other EU policy Union (EU) competency to create such a concerns. Inverting the image, and seeing framework for nurse education; but this nurse education as a major component is an oversimplification. The nursing of policy delivery within the EU opens a profession, the single largest workforce different perspective on the relationship in the EU, is subject to numerous EU between the ways that the workings of the policy structures and processes, not least EU both impacts on nurse education and is those designed to ensure workforce free- dependent on it for the successful delivery movement, harmonisation of training, of many of the health and consumer and mutual recognition of education Acknowledgement: This article related initiatives. is based on a chapter in the and training standards. Other policy forthcoming study: Rafferty AM, developments, especially in public This article will briefly describe Busse R, Zander B, Bruyneel L, health, education and consumerism, Sermeus W. The contribution developments in nursing education also influence nurse education, with the of nursing to heath system and mutual recognition of professional performance: A European current initiative on Active and Healthy qualifications, as well as identify the perspective. Copenhagen: European Ageing being an example. This requires key legislative and non-mandatory Observatory on Health Systems nurses to participate more actively in and Policies. influences, determined both within the patient adherence to medical prescriptions, EU and external to it, but applied within initiating falls prevention programmes, its policy framework. Finally, the adoption improving assessment skills in levels of a competency-based approach to nurse Tom Keighley is an independent of frailty and functional decline, and education within the EU context will health care consultant. developing more integrated health Email: [email protected] be addressed.

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A legal-base for nurse education EU policy making can move in step have the faculty to teach such competency- with non-EU bodies, and so influence based programmes or the clinical arenas to The enactment of the sectoral directives the framework for nurse education as provide the associated training and permit in 1977 brought closure to a nursing well. The Bologna Process to increase subsequent practice. Of greatest concern initiative pursued for over twenty years. 1 2 compatibility between European higher must be questions about quality of care It instituted a mechanism for both mutual education systems is one example, while and patient safety, issues not of concern recognition of qualifications in general the World Health Organization (Europe), 5 in a directive focusing on free-movement nurse training and the regulation of the International Labour Organisation of the workforce but which could be nursing practice. Over the next twenty on health and safety at work, 6 and the affected by the over-rapid development of years, there were several amendments, International Council of Nurses 7 have all the competencies. especially the agreement on the balance issued reports and advisories which have between theory and practice in the training influenced the content and shape of nurse Delegated acts are a new phenomenon. programmes. Further, there were advisory education in recent years. They are a mechanism to enable the documents on cancer, palliative care, revision of course content and approval of public health and care of older people to education developments without requiring act as a backdrop to the development of The current situation a revision of a complete directive. This is a training programmes, leading to a separate The revision timetable for mechanism that will apply primarily to the form of recognition which permitted the Directive 2005/36/EU slipped Annexes of the directive and circumvent free-movement of specialist nurses. 3 An considerably and in doing so illuminated the delays that reforms have experienced attempt in the late 1990s to move over the tensions between first order intentions in the past. While this is a positive to a competence-based approach to (improving the flexibility of the workforce development, it is still unclear quite how training failed but further revisions of the and associated free-movement at a they will operate. directives resulting in Directive 2013/55 time of financial crisis) and the wish finally achieved that goal. 4 of the nursing profession to see major The policy debate on nurse education improvements in the nature of nurse has been invigorated by the discussions training. Some decisions have been about the revision of the directive. In pushed through despite great concerns many countries in Western Europe, this moving about their deliverability. These include is the first time in over a decade that the Professional Card, the development governments have had to address the to competency- of competency-based education, and the framework of nurse education actively and creation of delegated acts. to encounter how this is seen both by the based education professions in their own countries as well The Professional Card, issued to all as the responses of other countries. The Non-mandatory, and not specific to nurse nurses in the EU since 18th January 2016, challenge, however, remains the same, education, but deeply influential on how contains details of their education and and that is how to have a policy debate nurse education has developed across registration. While a worthy idea, it about nurse education in the EU when the the EU, are the European Qualification does not address the complexity of the decisions about it are made secondary and Framework (EQF) and the European mutual recognition process, with several some cases tertiary to higher-level policy Credit Transfer and Accumulation System hundred regulatory organisations in which decisions. There is increased awareness in (ECTS). These have determined the recognition can be checked and the lack the Commission and amongst MEPs about academic level of nurse training that is ‘‘ of resources (both human and IT) in many issues like gender challenges implicit professionally desirable (EQF level 6) countries to ensure such a card is kept in decisions about nurse education and and the duration of training (180 credits). up-to-date. concerns about patient safety and quality This structuring has enabled a shift of of care. However, the focus now needs nurse education from mono-technical Article 31 of Directive 2013/55/EU lays to turn to whatever mechanisms can be schools and colleges into higher education out in broad detail the nature of the agreed to draft and implement specific university settings. The move has been competencies to be adopted in nurse competencies in line with the Directive, as contended by numerous governments education. These competencies have well agreeing the revision mechanisms to and remains a controversial development, been developed in great haste to meet the keep the Directive up-to-date while being especially in German speaking countries deadlines for the issuing of the Directive applied in a harmonised fashion across and some of the EU accession and recently and have not been tested. Further, they the EU. acceded countries in Central Europe. In have not been examined to determine how these countries, the combination of state- a person emerging from a programme level decisions about the status of different Challenges for accession countries designed around such competencies occupations and the appropriate level will integrate into the multi-disciplinary The stream of countries still preparing of associated education has previously arena that constitutes modern health to accede to the EU presents particular precluded nursing from integration into care delivery. More importantly, the challenges for nurse education. Turkey, higher education. competencies have been developed in the Montenegro, the Former Yugoslav knowledge that many countries do not Republic of Macedonia, and Albania

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are all working to achieve conformity exists for the Commission to work with be fair to state that examination of this with the EU directives. In nursing, this Member States on matters concerning implicit policy framework is rich territory requires not only the reform of nurse the training of nurses, unless this relates for those who wish to look in detail at education, but also fundamental changes to free movement of nurses. It has been the stimuli for change in nurse education to education at high school level and the a source of great frustration to the nurse and training and the drivers behind the re-classification of professions with all that associations and their representatives at aspirations and outcomes expressed in that entails in terms of remuneration and a European level that this cannot happen, nursing forums and publications cross social recognition. It is the area of reform even when consensus exists that such the EU. that has caused a focus to develop on discussion would aid all concerned. opportunities for women and their right to Despite creating a common platform References education. In particular, adopting the EU mechanism in Directive 2005/36/EC, directives that apply to nursing has shone which could have been used for the 1 European Economic Community. Council a lens on the historic communist types of reform of nurse education, no attempt Directive 77/452/EEC of 27 June 1977 concerning the mutual recognition of diplomas, certificates and education which even now have not been was made between 2007 (when the other evidence of the formal qualifications of nurses fully reformed. Directive became active) to 2012 to use it. responsible for general care, including measures Therefore, from the perspective of nurse to facilitate the effective exercise of this right of The major policy challenge for much associations, it seems fair to conclude establishment and freedom to provide services. of the EU and the accession countries that seeking specific policy direction Luxembourg. when developing nurse education is how for nurse education within European 2 European Economic Community. Council to generate the professional space to Commission procedures is currently not Directive 77/453/EEC of 27 June 1977 concerning permit comprehensive and autonomous a fruitful exercise. the coordination of provisions laid down by Law, Regulation or Administrative Action in respect of nurse practice to be delivered. The lack the activities of nurses responsible for general care. of integrated policy for nurse education However, decisions both within the EU Luxembourg. highlights the problem. The lack of and in organisations that relate to it have 3 European Economic Community. Council Directive negotiation with key stakeholders, created a de facto policy framework 89/48/EEC of 21 December 1989 on a general system like doctors and national law makers, which has demonstrated an evolutionary for the recognition of higher-education diplomas jeopardises the development of a capacity over time. What has emerged awarded on completion of professional education and competence-based education system. is a process of validation, some of which training of at least three years’ duration. Luxembourg. The resistance to such developments is embedded in law and some within 4 European Parliament and Council. Amending limits the opportunities for women voluntary ‘good practice’ frameworks Directive 2005/36/EC on the recognition of accessing higher education when it was which have reformed the nature of nurse professional qualifications and Regulation (EU) No not open to them in their nation’s previous education and training in the last two 1024/2012 on administrative cooperation through the Internal Market Information System (‘the IMI educational systems. In positive terms, decades and looks set to continue to do so. Regulation’) (Text with EEA relevance). Official the development of the EU directives on While the stimuli for this have emerged Journal of the European Communities, L354, 132 professional qualifications has resulted from a concern about creating a skilled – 170.

in the creation of regulatory structures and sophisticated workforce equipped for 5 World Health Organization Regional Office which, as a by-product, have not only the coming decades, and to ensure ease for Europe. European strategic directions for improved patient safety and quality of of movement between national borders, strengthening nursing and midwifery towards care, but also enabled nurses to engage nurse educationalists in particular have Health 2020 goals. Copenhagen, WHO Regional Office more fully with the decision-making reshaped delivery mechanisms and for Europe, 2015. concerning their career paths. In so doing, course structures to a profound degree. 6 International Labour Organisation. Occupational this process has assisted in addressing the So effective has it been that accession Safety and Health, 2016. Available at: http://www.ilo. internal democratic deficits in countries. countries aspire to imitate this in their org/safework/lang-en/index.htm reform proposals to the European 7 International Council of Nurses. The Code of Ethics for Nurses – Revised. Geneva, ICN, 2012. Conclusions Commission, even when the requirements exceed the legal requirements for No single policy or strategy has been accession to the EU. determined and pursued within the EU on nurse education and training. Indeed, Further, because nursing is considered to given the diversity of decisions and be one of the liberal professions, nurses influences it may come as a surprise have rights of individual establishment to some that such a framework has meaning that irrespective of what national emerged. The consequences of this governments, trade unions or nurse are multiple. It means that there is no associations may wish in attempting to particular focus within the European ensure conformity amongst practitioners, Commission structures whereby nurse individual nurses have the right to practice education matters can be discussed or based on their training and the recognition facilitated. Moreover, no mechanism of their qualifications. Thus, it would

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THE NETHERLANDS EU PRESIDENCY ON HEALTH

By: Edith Schippers

Summary: With several other pressing policy areas dominating the agenda of the Netherlands Presidency of the European Union, health issues still feature as valuable areas of focus. Building on the work of previous presidencies, the three main priorities of the current presidency are antimicrobial resistance, timely access to innovative medicines for patients at sustainable prices, and food product improvement, all of which have a clear cross-border dimension and require European cooperation. Through various targeted initiatives, such as conferences, roadmaps and facilitating mechanisms for improved coordination and cooperation among Member States, the Netherlands Presidency aims to bring action on these health priorities to the next level.

Keywords: The Netherlands EU Presidency, Health, AMR, Access to Medicines, Food Product Improvement

Introduction Legislative agenda In times when the European Union (EU) At the request of many Member States and is experiencing serious turmoil, the the European Parliament, the Netherlands Netherlands has taken over the Presidency Presidency, first and foremost, wants to of the Council of the European Union for bring the legislative agenda in Brussels the first half of 2016. The priorities for a step forward. High on this agenda are this presidency are innovation, growth the regulations on medical devices and and jobs, asylum and migration, robust in vitro diagnostics. These regulations financial policies and a common European aim to improve the system for market approach to climate and environmental access of medical devices and in vitro issues. A brief glance through the diagnostics, while respecting the balance newspapers gives an idea of what other between innovation and safety. Because issues – e.g. terrorism and the referendum these proposals contain stringent rules in the United Kingdom – might require of a highly technical nature, it has our attention as well. In this scheme of taken the Council a long time to find things, health and health policy might a solid basis for starting negotiations almost seem like a minor issue, and in the with the European Parliament. It is the recently published working programme of ambition of the Netherlands to reach an the European Commission, health plays a agreement between the Council and the Edith Schippers is Minister for modest role as well. However, many health European Parliament before the end of Health, Welfare and Sport, The challenges require European cooperation its presidency term. Challenging issues Netherlands. Email: [email protected] to find the best solutions. Therefore, the are questions regarding the regulation Netherlands has put together an ambitious of high-risk devices and how to balance but realistic agenda for health. innovation and safety aspects. Other

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issues are the reprocessing of single-use with measurable targets for the reduction 2) facilitating voluntary cooperation devices, liability of economic operators of AMR. In addition, all Member States in the field of pricing, and 3) analysis and requirements with regard to the use of should work on national plans with and discussion about unintentional and genetic tests. measurable targets. The Netherlands undesired incentives in the EU market suggested at the conference that a peer- access legislation. Three Presidency priorities review mechanism should be set up in the EU to monitor progress on implementation 1) Flexible market authorisation Besides the legislative agenda, the of AMR action plans and to identify mechanisms Netherlands Presidency aims to follow ways to better support each other with Obviously it takes time before medicines up on important issues on the European this implementation. receive a marketing authorisation, often agenda as addressed by previous up to ten years. Patients are calling for presidencies. The three health issues it has When it comes to the development of new faster access, also for products that cater chosen as priorities under its programme antibiotics, alternatives and diagnostics, for smaller patient groups and therefore are: antimicrobial resistance, timely access many good instruments and initiatives cannot follow the current phases of to affordable medicines for patients, are already in place. However, the results clinical trials. Therefore, in our view, it and food product improvement. These of these are often inadequate. At the is necessary to explore ways for better three issues all have a clear cross-border conference it was acknowledged that we use of flexible marketing authorisation dimension, in which European cooperation need a more focused European research mechanisms. This involves focusing on the is essential. agenda and commitment of all partners right (essential) products, better alignment to further support the implementation of of market access and reimbursement Antimicrobial resistance these initiatives. criteria in order to speed up the time- First, when it comes to the pressing topic to-patient, and also early interaction of antimicrobial resistance (AMR), the Finally, there is a common understanding with payers. numbers are telling. Every year 25,000 that it is important to present one clear and Europeans die due to untreatable common EU position regarding AMR in 2) Voluntary cooperation regarding bacterial infections. 1 Although we see a different international forums, such as the pricing growing awareness both at a European UN General Assembly. Together with the and global level, it often turns out to be other measures, this will hopefully bring The second focus is on how to counter difficult to put this awareness into action. European cooperation on AMR to the the ever increasing prices of medicines. Furthermore, it is essential to understand next level. The fragmented position of individual that the solution to this problem should not Member States reduces their leverage only be sought in the health sector. Other Timely access to affordable medicines when it comes to countervailing the sectors are important as well, in particular for the benefit of patients power of pharmaceutical companies in the veterinary sector. Secondly, following up on the Italian and the European market. This power comes Luxemburg presidencies, the Netherlands with the lack of competition for many The only effective approach is the would like to put the topic of timely access new innovative products because there One Health approach because without to affordable and innovative medicines are no or hardly any alternatives for the commitment of both the human health for patients on the European agenda. these medicines. and the veterinary world, the problem Medicines play a crucial role in the lives of AMR cannot be solved. To facilitate of millions of people in the EU: they It may be clear that exorbitantly high this approach, the Netherlands proposes cure people, give chronically ill people medicine prices put a lot of pressure on close cooperation between the health and a chance to lead an active and productive health care systems. The affordability veterinarian sectors, for a One Health life, and patients with severe illnesses of health care systems is at stake. approach at the EU-level. In line with this have gradually obtained a better quality of One of the key ingredients in this approach, the Netherlands aims at securing life and an increasing chance of survival. respect is improving the checks and firm political commitment to binding Recently, remarkable advances have balances between governments and the agreements for prudent use of antibiotics been made in this field. However, these pharmaceutical industry. The Netherlands in veterinary medicines, including a developments come at a cost: prices of EU presidency would like to address how ban on the use of antibiotics which are new innovative pharmaceutical products countries can voluntarily work together critically important for human health. To have dramatically increased, while on at a strategic level – but also in practical establish this political commitment, a joint the other hand, more and more medicinal terms – on the issue of pricing, to restore ministerial meeting for both ministers of products come to the market for smaller the balance between the public interest Health and ministers of Agriculture was groups of patients. It should be our overall and the interest of the private sector in organised in February, and the issue will goal to make innovative medicines the pharmaceutical market. Joint ‘horizon be discussed further in relation to draft available to severly ill people, while scanning’, sharing information on prices Council Conclusions. ensuring the sustainability of our health and price setting between countries, or care systems. Our focus is threefold: even shared price negotiations could be a During the conference there was broad 1) optimising flexible market authorisation good start to ensure sustainable health care political support for a new EU action plan mechanisms under the right conditions; systems, now and in the future.

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3) Undesired and unwanted incentives important instrument for countering the tackle all aspects of the challenge that in EU market access legislation rise of non-communicable diseases and dementia poses. Member States should making the healthy choice the easy choice. work together in research into the cause, Thirdly, existing and ‘built in’ incentives The call for improved food products also cure and prevention of dementia, and in the EU market access legislation are offers opportunities for innovation. share best practices on how to include meant to promote innovation. The question people in the early stages of dementia is, however, whether instead they disturb Fortunately, many Member States are in society for as long as possible. Other the balance between innovation and already taking action at a national level topics that will be touched upon during the availability on the one hand, and costs on and several food business operators Netherlands presidency are ehealth and the the other. To stimulate industry and other have started to improve their products. safeguarding of qualifications of medical parties to develop medicines, including These trends are encouraging. However, professionals in cross-border settings. for specific rare diseases or small patient the food business is in essence a cross- groups, additional incentives, such as border business. The lack of a harmonised data protection, supplementary protection The next level approach undermines the level playing certificates and market exclusivity for field and hampers product innovation. To conclude, as noted, health may not be orphan drugs, were created. These As a first step towards more concerted in the top three of all the challenges the incentives have proven to be successful action, the Netherlands organised a EU currently faces, but there are enough in terms of new products coming onto the Conference on Food Product Improvement important health issues that require and market. However, there is a downside, on 22 February 2016. At this conference, deserve our collective European attention. as these incentives lead to high-price a joint Roadmap for Action, 2 was The Netherlands believes that with its products that affect countries’ health supported by Member States, trade and presidency’s health agenda pressing issues budgets. In the Netherlands’ opinion, it industry organisations and NGOs. The will be brought to the next level, which is is therefore urgent to discuss whether Roadmap should lead the way towards necessary to improve and safeguard the the current incentives are still in balance stronger concerted action. The results of health of all European citizens. or lead to too many unintended and the conference will be shared with the unwanted effects. informal Health Council in April 2016. References

Food product improvement 1 European Commission. AMR: a major European Additional health policy concerns The third priority under the Netherlands and global challenge. Fact Sheet. Available at: http:// ec.europa.eu/dgs/health_food-safety/docs/amr_ presidency is food product improvement. Apart from these three main priorities, factsheet.pdf As is well-known, health is interconnected there are a few other health concerns 2 with eating habits. An unhealthy diet that will be addressed during the EU Ministry of Health, Sport and Welfare. Roadmap for Action on Food Product Improvement. Available increases the risk of non-communicable presidency. One of these is dementia. Since at: https://www.rijksoverheid.nl/documenten/ diseases like diabetes, cardiovascular the French presidency in 2008, successive formulieren/2016/02/22/roadmap-for-action-on- diseases and obesity. However, even if presidencies have made dementia a food-product-improvement people try to eat healthily, they often risk priority. The Netherlands would like to consuming too much salt, sugars and continue the European collaboration in saturated fats, as processed food products this field. The time is right to combine contain too much of these ingredients. the numerous activities in every Member Food product improvement can be/is an State into an integrated approach to

France: Health system review inequalities across socioeconomic and geographical groups are much larger in France than in most other European countries. The rising cost of health care also remains a By: K Chevreul, KG Brigham, I Durand-Zaleski and challenge for the health system, C Hernández-Quevedo with public financing of health care Copenhagen: World Health Organization 2015 (acting as expenditure among the highest the host organization for, and secretariat of, the European in Europe. While the latest health Observatory on Health Systems and Policies). reforms aim to address these challenges, long-term care reform Number of pages: xxvii + 218 pages, ISSN: 1817-6127 efforts have thus far failed to Freely available for download at: www.euro.who.int/__data/ identify a sustainable financing assets/pdf_file/0011/297938/France-HiT.pdf?ua=1 mechanism to meet this large and growing need. While the French population is largely satisfied with the health system, the overall state of health in France is mixed. Health

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THE CROSS-BORDER CARE DIRECTIVE: IMPLEMENTATION STATUS

By: Willy Palm

Summary: The first report on the operation of the Directive on patients’ rights in cross-border health care shows mixed results. So far, patient mobility remains quite low in general, which may partly reflect limited motivation among European Union (EU) citizens to travel for care. However, it also relates to two other factors. First, despite several measures to improve information, many patients remain unaware of their rights. Second, Member States seem to limit the reimbursement of cross-border health care through imposing administrative requirements, applying unjustified low reimbursement rates or maintaining elaborate systems of prior authorisation. The European Commission is committed to enforce full compliance of the Directive.

Keywords: Cross-border Care, Patients’ Rights, Directive 2011/24/EU, European Commission

Transposition status Member States had until 25 October 2013 to transpose the Directive into national The Directive on the application of law. Up to this date the European patients’ rights in cross-border health Commission assisted Member States – care came into force on 24 April 2011. 1 through country visits and workshops – It was the result of a long process, initiated in finding the best ways of transposition, by a series of consecutive rulings of the taking into account the specific context Court of Justice since 1998 about how the of each health system. After the deadline fundamental principle of free movement of it launched infringement proceedings services would directly apply to the case of against 26 Member States for late or reimbursing medical treatment purchased incomplete transposition of the Directive. in another Member State. 2 This Directive Since then all Member States seem to was meant to clarify the conditions have complied with the obligation of under which cross-border health care is transposition, the clearest sign being the covered by the statutory health system of creation of National Contact Points (NCP) affiliation, but also what rules would apply Willy Palm is Dissemination which are meant to inform patients’ about to ensure patient safety and good quality Development Officer, European the conditions under which they can Observatory on Health Systems health care (see Figure 1). and Policies, Brussels, Belgium. receive health care in another Member Email: [email protected] State. However, this does not mean that

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Member States have transposed the Figure 1: Directive 2011/24/EU on the application of patients’ rights in cross-border Directive correctly. The Commission is healthcare (objectives and constitutive elements) now pursuing a compliance check, which could lead to a new series of infringement procedures against certain Member States.

A recent report on the operation of the Directive, released by the European Commission in September 2015 (and which must be issued every three years from now on), already gives an indication of the variation in which Member States have translated and implemented the different elements of the Directive. 3 Despite clear anomalies in some cases, in its report, the Commission carefully refrains from naming and shaming the Member States who are overstepping their discretionary power, so as not to jeopardise the legal force of the possible infringement proceedings for non- Source: W Palm compliance that may be launched against some of these countries. local consular official (Greece). Although States are expected to specify these Member States are in principle allowed to categories and to publicly state for which Obstacles to reimbursement uphold a gatekeeping system for accessing health care services prior authorisation specialised care (if it can be objectively is still needed. However, most Member The first and primary objective of this justified), the Commission seems to States have essentially copy-pasted the Directive was to facilitate access to cross- question the practice in several Member criteria of “overnight stay” and “highly border health care by clarifying patients’ States that the referral should be provided specialised care” into their national rights to statutory coverage in line with the by the general practitioner with whom legislation without really specifying what jurisprudence of the Court of Justice. The patients are registered in their country. categories of treatments are covered under general principle set by the Directive is Furthermore, at least four Member States one or the other. Those countries that that any treatment provided by a registered seem to apply a lower reimbursement rate actually provide more detailed lists of health provider in another Member State for cross-border care, the same as the one treatments, vary considerably in scope. should be reimbursed according to the they apply for private or non-contracted Some specify the services (out-patient and same tariffs and conditions as the one providers in their country. Already in-patient) for which prior authorisation applying in the state of affiliation. Clearly, in 2013, the former Health Commissioner is still needed, whilst others apply broad the margins for Member States to limit Tonio Borg stated in a response to a categories and basically exclude all cross- reimbursement for cross-border health question from a Dutch MEP, Ria Oomen- border in-patient care from unconditional care or to impose additional conditions Ruijten, that such practices would reimbursement under this Directive. In were narrowed significantly. In essence, constitute a disincentive for patients to use this context, another element of confusion any restriction would need to be justified their rights to cross-border health care and occurs when certain medical interventions by so-called “overriding reasons of would need to be justified. could be treated as day-cases in one general interest” and should prove to be Member State but not in another. As this proportionate and necessary with regard to The report also demonstrates that several criterion of “overnight stay” is part of the this objective. In addition, such measures Member States are still maintaining reimbursement rules, prior authorisation should be notified to the Commission. comprehensive prior authorisation could only be justified if the treatment systems, whereas the Directive curtailed would require it in the home state. In practice, several Member States Member States’ power to make the However, according to the Commission, seem to stretch their discretionary reimbursement of cross-border care some Member States instead refer to power (see Table 1). The Commission subject to prior authorisation. Such a what is the standard in the Member State provides several examples of additional condition can essentially only apply for of treatment. administrative requirements that patients more complex forms of treatments, i.e. need to fulfil: document the medical health care that is subject to planning As was also confirmed by an evaluative necessity of a particular treatment abroad requirements and involves either study undertaken on behalf of the (UK), provide a sworn translation of overnight hospital stay or the use of highly Commission, 4 it is often not clear for foreign invoices (Bulgaria) or even a specialised and cost-intensive medical patients when they actually need to ask certification of all documents by the infrastructure or equipment. Member for prior authorisation, and even when

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Table 1: Conditions for reimbursement of cross-border health care under Directive 2011/24/EU

Scope of prior authorisation Member States applying Member States requiring In all No or unclearly Clearly defined a lower reimbursement a ‘domestic’ referral for circumstances defined list (1) list (2) Never (3) rate reimbursing claims AT, BE, BG, DE, DK, HR, HU, LV, MT, PT, CZ, EE, FI, LT, AT, DE (4), IE, MT, IT, EE, LT, LV, RO, CY EL, ES, FR, IE, IT, LU, RO, SK, UK NL, SE FI, NL SK, SI, PL PL, SI

Source: Author’s own analysis based on information drawn from the National Contact Points (February 2016).

Notes: (1) This means that the scope as defined in the Directive is not further detailed, or only partially (in several instances the criterion of “overnight stay” remains unspecified); (2) This does not necessarily mean that the scope as defined is in conformity with the principles of necessity and proportionality; (3) Some countries still preserve the legal possibility of introducing prior authorisation and defining its scope at a later stage; (4) Germany applies a 5% reduction as an administrative fee to process claims.

there are lists interpreting them usually Low awareness among patients and kind of health care they can expect requires some degree of medical expertise. to find abroad, as well as the quality The complexity of the legal situation, This is why patients may still have to and safety standards that apply there. with two distinct reimbursement regimes contact their NCP or their health insurer Indeed, even more than the financial for cross-border care (the Directive and to get additional clarification. Apart uncertainty, people are put off by the the Regulation), as well as the national from the persistent lack of transparency, lack of information about the availability, variations in transposition, interpretation most Member States seem to forget that quality and safety of treatment abroad and transparency, make it extremely extensive systems of prior authorisation and the insecurity about what might difficult for patients to understand their can only be justified if they prove happen when something goes wrong rights and make use of them. Despite the to be necessary and proportional for (see Figure 2). While quality is also one efforts and provisions in the Directive achieving objectives of general interest, of the main motivations for patients to to ensure good information about such as maintaining financial balance seek care abroad, reliable, comparative patients’ rights and entitlements as well and universal access to quality health and systematic information on provider as procedures for accessing them, a services within their health system as performance seems to be the most wanted Eurobarometer study published in 2015 well as ensuring patient safety and public but also least available. The NCPs mainly revealed that only 17% of respondents felt health. Given the extremely low number provide generic information, often just they were well-informed about their rights of requests for prior authorisation (see links to legal or policy documents on to treatment in another Member State ‘Low patient flows’ section) this seems quality and patient safety, and only a (compared to 49% in their own country). 5 to be hardly the case. One country few provide more practical and detailed In fact, only 57% seemed to know that (Cyprus) even continues to request prior information on individual providers. they had a right to reimbursement for care authorisation in all circumstances (except received in another Member State. Less for one specialist consultation per patient The European Patients’ Forum, which than one in three knew that they could use once a year). Only six countries no longer between 2013 and 2015 organised a a medical prescription in another Member require any prior authorisation for the series of regional consultations with State. A key instrument for filling this reimbursement of any type of medical national patients’ organisations on the knowledge gap was the establishment of treatment under this Directive. But even implementation of the Directive, has NCPs in each Member State to enable both in those countries, prior authorisation is also named the variable quantity and outgoing and incoming patients to make still needed when patients seek planned quality of information made available to use of their rights. However, only one in health care under the traditional – and patients as one of the main challenges for ten seems to be aware of their existence. often more advantageous – route of its success. To this end, it also calls for a This also correlates with the low activity the Social Security Coordination closer and more systematic involvement level of the NCPs so far, as was shown by Regulation 883/2004, which guarantees of patients’ organisations to ensure that the evaluative study and other sources. reimbursement according to tariffs of the the information provided meets patients’ Most information is drawn from NCP state of treatment.* needs. 6 Another study requested by the website visits, less from telephone, email European Commission, which looked at or face-to-face contacts. the NCP websites, suggested that next to more detailed information on providers, a * The EU social security coordination framework, which Furthermore, questions have been raised review system should be created similar is enshrined in this Regulation that was revised in 2004, has about the quality of information provided to those used on travel and hotel websites, for decades ensured access to health care outside the state and its usefulness for patients to make of affiliation for migrant workers, their family members and where patients could post reviews informed decisions around seeking finally all statutorily insured citizens. It applies in parallel to about their experiences with health care treatment in another Member State. The the Directive and in general it offers better financial protection providers in different countries. 7 since patients are covered as if they were insured in the Member uncertainty surrounding cross-border care State of treatment, whereas under the Directive they are only not only relates to patients’ entitlements to reimbursed afterwards according to the applicable tariffs of reimbursement but also to the availability their home state.

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Figure 2: Eurobarometer survey results on patients’ reasons for not using cross- only be measured in numbers. In fact, border health care, 2007 and 2015 the legal framework was never meant to encourage patients to seek health care abroad, but rather to facilitate it in case there was a real need or a true desire for it. Meanwhile, under the Directive’s chapter that stimulates cross-border cooperation in the field of health care, important things are happening that will produce practical and useful outcomes for patients, such as the creation of European Reference Networks to better treat patients with complex or rare conditions. This, together with the pressure on Member States to improve transparency and information, to attach importance to patient safety and quality as well as to patients’ rights in

Source: Source: Eurobarometer Eurobarometer 2015 2015 and 2007 and 2007 general, will also turn out to be beneficial for domestic patients. Low atient p flows The Commission report also tries to give an indication of the actual patient flows D resulting from the operation of this irective. The data provided cover the year of 2014, the first year after the transposition of the Directive. Considering the late iance compl of most Member States, the remaining obstacles with reimbursement and the low level of awareness it is not surprising that Low the patient observed numbers flows are quite low. Of those countries that were in able 2014 to the provide Commission data on the described operation of the Directive in 2014, six (Austria, the Bulgaria, Cyprus, Estonia, Greece and Portugal) made no reimbursement at all. Most reimbursements were recorded in Denmark (over 31,000). In 17 Member States References still using prior authorisation under the Directive only 560 current situation as “a dearth of statistical The Commission report also tries to 1 data on cross-border healthcare”, which For a more detailed overview see: Peeters M. give an indication of the actual patient Free Movement of Patients: Directive 2011/24 does not allow policy makers to properly 5 flows resulting from the operation on the Application of Patients’ Rights in monitor and assess the financial impact of this Directive. The data provided Cross-Border Healthcare. European Journal of of the application of the Directive on the cover the year of 2014, the first year Health Law 2012;19:29 – 60. DOI: http://dx.doi. Regulation. 8 However, the report also org/10.1163/157180912X615158 after the transposition of the Directive. suggested that if Member States wanted 2 Considering the late compliance of most Palm W, Wismar M, van Ginneken E, et al. to maintain a prior authorisation system Member States, the remaining obstacles Towards a renewed Community framework for safe, under the Directive they would need high-quality and efficient cross-border health care with reimbursement and the low level considerably improved data to demonstrate within the European Union. In Wismar M, et al. of awareness it is not surprising that that such systems meet the overall (eds.) Cross-border health care in the European the observed numbers are quite low. Union Mapping and analysing practices and policies. requirements of proportionality. Of those countries that were able to World Health Organization on behalf of the European provide data on the operation of the Observatory on Health Systems and Policies, 2011: So far, nothing seems to suggest that the 23 – 46. Available at: http://www.euro.who.int/__ Directive in 2014, six (Austria, Bulgaria, Directive may have increased or further data/assets/pdf_file/0004/135994/e94875.pdf Cyprus, Estonia, Greece and Portugal) stimulated patient mobility in the EU. 3 made no reimbursement at all. Most Commission report on the operation of Directive The 2015 Eurobarometer survey even 2011/24/EU on the application of patients’ rights reimbursements were recorded in showed a slight decrease in the general in cross-border healthcare, 4 September 2015, Denmark (over 31,000). In 17 Member willingness to travel for care compared COM(2015) 421 final. Available at: http://ec.europa. States still using prior authorisation eu/health/cross_border_care/docs/2015_ to the initial survey conducted in 2007: under the Directive only 560 requests operation_report_dir201124eu_en.pdf on average 46% of respondents were were received, of which 360 were 4 averse to the option of cross-border Evaluative study on the cross-border healthcare authorised. This is rather insignificant Directive (2011/24/EU), Final report, 21 March care, with the highest share in France compared to patient flow data under 2015. Available at: http://ec.europa.eu/health/ (78%) and the lowest in Malta (10%). In the Social Security Regulations: cross_border_care/docs/2015_evaluative_study_ addition, Eurostat’s European Core Health frep_en.pdf over 30,000 prior authorisation requests Indicators (ECHI) database confirms the 5 and 1.6 billion claims processed in 2013 Patients’ rights in cross-border healthcare in picture of low patient mobility showing (incl. unplanned care). the European Union, Special Eurobarometer 425, that only an average of 2.9% of people May 2015. Available at: http://ec.europa.eu/public_ discharged from hospital were non- opinion/archives/ebs/ebs_425_en.pdf Perhaps most puzzling is that after all residents, with only Luxembourg (10.3%) 6 these years the Commission is still not in European Patients Forum. Cross-border and Malta (5.8%) above that level. healthcare: is it working for patients across the EU?, a position to provide an accurate picture Conference Report, 13 July 2015. Available at: http:// of patient flows, mainly because in several www.eu-patient.eu/globalassets/events/2015-ceu- cases the data that should be provided by Conclusion cbhc/20150917-cbhc_report_final_external.pdf Member States are either not available or Despite the obvious benefits for patients, not sufficiently aggregated. The Directive only few patients seem to use the rights did not really include a clear obligation under the Directive. Nevertheless, the for Member States to systematically keep real impact of the Directive should not and share this kind of data. In a report

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7 Impact of information on patients’ choice MAKING SENSE OF within the context of the Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare, August 2014. Available at: http:// EUROPEAN UNION ec.europa.eu/health/cross_border_care/docs/ cbhc_information_patientschoice_en.pdf

8 Report from the Commission to the Council HEALTH LAW and the European Parliament compliant with the obligations foreseen under Article 20(3) of 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, By: Tamara Hervey, University of Sheffield 3 February 2014, COM(2014) 44 final. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/ ?uri=CELEX:52014DC0044&from=EN

Summary: Health policy communities make many claims about the EU’s health law, often from a position that EU law is ‘bad for health’. In an extended analysis, Hervey and McHale have assessed these claims. This article summarises some of their key findings. Overall, while the strong version of each claim is not borne out, once we immerse ourselves in the details of law in its policy contexts, a weaker version may well be defensible.

Keywords: European Union Health Law, Consumerism, Rights, Equality, Solidarity, Competition, Risk

Introduction because EU health law understands the relationships between doctors and their For nearly 20 years, Jean McHale and patients through the lens of consumerism. I have been researching the European Union’s (EU) health law. During that Second, it is claimed that, if patients’ time, we have heard many claims rights become essentially consumer rights, about EU health law from health policy the recognition of health rights as human communities. In our latest publication rights is diminished in EU health law. European Union Health Law: Themes and EU health law involves consumerisation Implications, 1 one of the things we do is to of health care, so it enhances individual assess those claims. We do so through four patient autonomy and patient choice. But themes: consumerism; (human) rights; that means that the collective ‘right to equality, solidarity, and competition; health care’ (despite appearing in the EU’s and risk. own Charter of Fundamental Rights) is not sufficiently protected in EU health One claim is that EU law treats health law which works to strengthen individual products and health services as essentially claims to health care resources as claims the same as any consumer product of right. available in the European market. Patients essentially become consumers, subject to EU health law involves more patient rules such as caveat emptor, even if they choice. But that increased choice weakens are protected by law from at least some the position of national health care products and services that would harm systems. They seek to provide care for all Tamara Hervey is Jean Monnet their health. Notions of a professional ethic equally, on the basis of need, with limited Professor of EU Law, University of care, or provision of public service, are of Sheffield, England. resources, predominantly funded either consequently fundamentally undermined, Email: [email protected] by taxation or through social insurance.

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The fundamental basis of health care in products available in the European over time (Chapter 8). EU law also European contexts is solidarity. National market (see Chapters 5, 11, 12, 13, 14, 17 understands patients’ rights in at least arrangements for health care provision in of European Union Health Law). Prior three other ways: patients’ rights as a EU countries involve monopoly, or near marketing authorisation applies, involving distinct legal category; the social security monopoly, of providers of health care oversight of research, development, and entitlements of migrant workers; and rights services. Looking at health systems as manufacturing, as well as post-market of patients to consume services in the EU’s markets, EU health law scrutinises such surveillance. The ways in which EU health internal market. In particular, the latter is behaviour and the concentration of market law treats health products or services more related to consumer rights than to power through mergers of health care as requiring special legal regimes are fundamental human rights. providers. EU health law is moving health incomplete: some products that are, or may care systems towards market-based models be, especially harmful to health (such as Where it opens access to health care across of regulation. Therefore, it is claimed that pharmaceuticals, products derived from borders in the EU, EU health law enhances EU health law challenges, disrupts, or human blood, tissue, or cells, and tobacco) patient choice, and patient autonomy. even destroys, those fundamental bases are the subject of EU-level legislation These concepts are related to the human on which national health systems are which aims, at least in part, to mitigate rights to privacy and dignity. But specific organised, as well as their underlying those potential dangers (Chapters 12, 13, legal entitlements are very difficult to ethos. EU health law is ill-equipped to 14, 17, 18). But the regulation of others enforce as human rights in EU law, not balance equality and solidarity with fair (such as food or alcohol) is left more to the least because of the significant national and effective competition. discretion of Member States (Chapters 15 discretion accorded to the interpretation and 18). and implementation of relevant human Finally, we hear both the claim that the rights provisions. Thus, national EU is too strict in its regulatory approach EU law treats health services quite health care systems are unlikely to be to risk (i.e. is significantly more risk- distinctly from the way it treats general significantly affected by EU health law on averse than, say, the USA) and that it is consumer services (Chapters 4, 6, 7, 8, 9, human rights (Chapters 4, 7, 9 – 11). not strict enough. Firms operating in the 10, 17). Overall, there is little EU-level EU are said to be saddled with competitive regulation of health services per se – the The impact of competition and choice disadvantage when seeking to compete organisation and delivery of such services globally. Innovation in European health within national health systems is a matter Monopolistic or near-monopolistic industries is hampered, stifling economic for national law. EU health law does not national arrangements for providing health growth. Patients waiting for a treatment for conceptualise patients entirely within a care may be subject to EU law which their currently incurable conditions have to consumerist perspective (Chapters 4, 5, 7 controls abuse of such concentrations of wait longer than they should. Alternatively, and 8) and particularly, where treatments market power. But important exceptions it is claimed that pre- and post-market are ethically controversial, EU health law apply to the application of EU competition controls of health care products, such as leaves significant discretion to national law to health institutions. EU health pharmaceuticals, bio- or nano-technology regulatory settlements (Chapter 4). law recognises health as a special type products, and especially medical devices of service: although it falls within the are insufficiently stringent to protect EU law touches upon regulation of health ordinary rules of competition, state vulnerable patients. On the other hand, professions, and where it does so, it aids and public procurement law, many it is also claimed that when it comes to understands the relationships between important exceptions to those rules apply other products that are or may be harmful health professionals, the national health in health contexts (Chapters 9, 10, 11). to health, such as tobacco, food, alcohol, (insurance) systems within which they EU health law is too permissive. operate, and the patients for whom they It is important to point out that nothing care, through a service-provider/receiver in EU health law moves health care Our overall findings are that, while the model, which is grounded in consumerism. systems towards market-based models of strong version of each claim is not borne But again, the scope of EU law is regulation, although if national systems do out, once we immerse ourselves in the limited, and national approaches based so through political choice, EU law may details of law in its policy contexts, a on a professional ethic of care, patient have the effect of de facto preventing or weaker version may well be defensible. protection and safety, or provision of impeding a return to a less market-based Here is some of the detail. Readers are public service, remain in place (Chapters 6 system (Chapters 9, 10, 11). welcome to consult the indicated book and 10). chapters for a more in depth discussion of Where individual patients enforce rights individual points. Rights to consume health services within the EU’s internal market, EU health law Consumerism EU law on patients’ rights incorporates supports patient mobility and the right the human right to health. At present, to individual freedom of choice. The Most health products (and medical the implications are more symbolic than arrangements of national health systems devices now coming into line) are not real, but emergent interpretations of EU are subject to scrutiny where they treated in the same way as other consumer citizenship rights may alter this position constrain such freedom. As a minimum,

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their rules concerning access to medical At a systemic level, EU health law’s (Chapters 12 – 14). On the contrary, EU law treatment must comply with principles increased patient choice has much less requires significant and detailed pre- and of individual assessment of patient of an effect than is often supposed on post-market control of these things. needs, non-discrimination on grounds the delivery of health care through of nationality, and judicial reviewability systems that are organised on the basis of Some other products which are or may (Chapters 4, 5). These aspects of EU solidarity. Solidarity-based systems are be harmful to public health are also health law have the potential to affect the predominantly funded either by taxation subject to detailed EU legislation, for solidarity-based provision of health care or through social insurance. They seek to instance on labelling, restrictions on within EU countries – increased choice secure equality of access to health care advertising, and composition rules. EU for some patients implies reduced choice according to need. Any effects of EU law law on tobacco is the example of most for others, because health systems have are indirect only, because countervailing complete health-focused legislation; limited resources. In addition, consumer aspects of EU law prevent patient choice, food is subject to some detailed EU law autonomy in patients implies a reframing or other actions of market participants, aimed at health protection; EU alcohol of doctor-patient relationships, suggesting from ‘unravelling’ national health systems law leaves significant national discretion changes to the way health professionals (Chapters 4 – 6; 9 – 11). (Chapters 15, 18). Nonetheless, EU law relate to the health systems within which has secured at least some significant they offer services (Chapter 6). The Regulation and risk improvements in public health. reconfiguring of health care relationships has positive implications for patient choice It is unclear whether EU law results in Conclusion and autonomy, and potentially negative competitive disadvantage for European implications for equality and access to health industries which seek to compete There is more to EU health law than free health care according to professionally globally, and consequent impediments competition and under-regulated market assessed patient need. Where an individual to innovation in such industries, and to choice. Furthermore, EU internal market patient enforces an entitlement under EU economic growth. From the point of view and competition law are used to support law to access medical treatment in another of patients who hope for novel medical a range of objectives other than economic EU country, in circumstances where their treatments to become available, it may efficiency and free trade in a narrow sense. home country has not authorised that be good news that EU law on clinical EU health law also promotes social and treatment, the professional assessment of trials and pharmaceuticals is centrally ethical goals. Over-generalised statements their medical need which underpins that concerned with ensuring that products about the effects of EU law on health access looks more like gatekeeping to reach the market (Chapters 12 – 14). systems, patients, health professionals, and access a personal choice, than gatekeeping public health should be seen for what they within a system that seeks to deploy Many have associated EU law with a are: too simplistic. A deeper understanding limited resources fairly. precautionary approach to risk regulation, of EU health law recognises both the favouring on balance the risks of harm to potential threats to health implicit in the But where legal persons (companies) seek patients against freedom to run a business. dynamics of EU law, but also the potential to rely on the rules of the EU internal But others take the view that EU law is benefits and advantages. market to trade across borders in ways no more restrictive of industry or capital which disrupt national health systems, than any other legal system. This is References we see a different pattern emerging. In especially so of the restrictions EU health areas most integrated within the operation law imposes (or, rather, it is argued does 1 Hervey T, McHale J. European Union health law. of national health systems, including not impose) on the global pharmaceutical Themes and implications. Cambridge: Cambridge University Press, 2015. social insurance provision, hospitals, industry (Chapters 12, 13, 17, 18). Available at: http://www.cambridge.org/ laboratories and blood centres, EU law us/academic/subjects/law/european-law/ operates under a ‘light touch’ approach, When it comes to assessment of risk in european-union-health-law-themes-and- which allows countries to justify national EU health law, medical devices regulation implications?format=HB institutional arrangements, provisions is an outlier, but will almost certainly not and practices which on their face breach remain so (Chapter 14). Comparatively EU free movement or competition law speaking, EU health law does not have (Chapters 9, 10). Furthermore, matters a light touch approach to regulation of such as the pricing of pharmaceuticals pharmaceuticals, bio- or nano-technology within health systems, which operates products, products involving human through nationally negotiated settlements, blood, tissue or cells, or of whole human have, by and large, not been disrupted by blood or plasma, or human organs EU law (Chapter 11).

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MANAGED ENTRY AGREEMENTS FOR NEW MEDICINES IN THE BALTIC COUNTRIES

By: Dia¯ na Ara¯ ja and Keili Kõlves

Summary: Managed entry agreements (MEAs) have become a topical issue due to the increasing cost of new medicines and the presence of significant uncertainty at the time of making reimbursement decisions. There are uncertainties about clinical and economic evidence, fair prices and budget impact, as well as about the eligible patient population. Innovative solutions are needed to make new medicines available to patients and to ensure the long-term financial sustainability of health care systems. This article outlines the use of MEAs in Estonia, Latvia and Lithuania as part of their pharmaceutical policy arsenal to improve access to new medicines.

Keywords: Managed Entry Agreements, Reimbursement, Pharmaceutical Policy, Estonia, Latvia, Lithuania

Introduction The most common features of MEAs across European countries are Price- A Managed Entry Agreement (MEA) is Volume Agreements (PVAs) (39.2% of an arrangement between a manufacturer total MEAs), followed by requirements and a payer/provider that enables access for data collection (29.2%), limited access to coverage/reimbursement of a health to eligible patients (13.0%), conditional technology subject to specified conditions. continuation (5.6%), payment by result These conditions can be either financial (5.4%), discounts (4.6%), dose price time or health outcome-based, and different cap (2.2%) and price match (0.8%). 2 MEAs types of MEAs exist for each of these are often used for high-cost patented two groups. These arrangements can drugs for which there is limited evidence use a variety of mechanisms to address of effectiveness in a non-controlled uncertainty about the performance of environment and of long-term effects. 2 technologies, to reduce uncertainty around the clinical effectiveness and/or Effective pricing, reimbursement and cost-effectiveness of a technology in real rational use of medicines are goals of all Dia¯na Ara¯ja is Acting Director life, to limit the budget impact of a new three Baltic States, along with facilitating of the Department of Pharmacy technology, or more generally, to manage at the Ministry of Health, Latvia access to new medicines. Within this the adoption of technologies in order to and Keili Kõlves is Head of the context Estonia, Latvia and Lithuania Medicines and Medical Devices maximise their effective use. 1 Division at the Estonian Health share similar reimbursement systems, Insurance Fund, Estonia. namely: Email: [email protected]

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• Medicinal products are reimbursed on Figure 1: State budget resources allocated for the reimbursement of expenditures for the basis of the diagnosis. the acquisition of medicinal products and medical devices intended for out-patient medical treatment in Estonia, Latvia and Lithuania (€ per capita), 2008 – 2014 • Reimbursement rates are divided according to the character and severity € per capital 100 of the disease. 94 Estonia

• There are positive lists of the Lithuania 80 medicines and medical devices that 80 77 are reimbursed. 72 73 72 74 Latvia 69 64 64 • Medicinal products are reimbursed in 59 60 58 58 60 60 57 accordance with reference prices and 55 57 48 individual agreements, if these exist. 45 45 • Since 2002, the Baltic Guidelines 40 for Economic Evaluation of Pharmaceuticals have been used 20 to perform pharmacoeconomic evaluation. 3 However, the state budget resources 0 2008 2009 2010 2011 2012 2013 2014 allocated for the reimbursement system are different in the Baltic countries (see Figure 1). In Latvia, this Source: Ref. 4 amount is significantly lower than in was launched in January 2003 and pricing decisions for in-patient medicines neighbouring countries. involves grouping pharmaceuticals on the are made by the Estonian Government basis of active ingredients (Anatomical after receiving a proposal from Estonian In the following sections, we provide an Therapeutic Chemical (ATC) classification Health Insurance Fund. outline of the reimbursement systems ATC-5 level), pharmaceutical form and in Estonia, Latvia and Lithuania and route of administration. Acceptable cost-effectiveness of medicines the use of MEAs to help meet their is a priority to ensure equal access among pharmaceutical policy goals. At the manufacturing level, there is patients. In Estonia, there are several statutory pricing (after negotiations) options to help achieve an acceptable price Estonia for reimbursable pharmaceuticals. The level, including: procedures for setting a manufacturer’s The health insurance system in Estonia • Confidential discounted wholesale prices differ depending on whether the covers the costs of health services prices agreed between the Ministry pharmaceutical is an innovative or a provided to the insured population to of Social Affairs (MoSA) and the generic product. There are specific criteria prevent and cure diseases, finances the Marketing Authorisation Holder for the reimbursement of generics: the purchase of medicinal products and (MAH). price of the first generic has to be 30% medical devices, and provides temporary lower than the price of the primary • Cost sharing agreements (since 2014). sick leave benefits for the employed. 5 authorised product on the market, the Only medicines included in the Estonian • Risk sharing agreements (since 2014), prices of the generics that follow have to Health Insurance Fund’s (EHIF) Positive including performance-based MEAs, be 10% lower and starting from the fifth List of medicines or in the List of Health which have been introduced in recent generic the price should not be higher than Services are reimbursed. However, there years for a number of indications the fourth. The statutory price levels are are special reimbursement mechanisms (see Table 1). set according to the prices of the product (reimbursement on a named patient basis) in three reference countries (Latvia, The MoSA website contains summaries available for medicinal products without Lithuania and Slovakia). If applicable, of the reference prices and price a marketing authorisation in Estonia. and if similarity is proven, the prices of agreements, including all the prices of pharmaceuticals with similar effects are reimbursed out-patient medicines. The Medicinal products are reimbursed based also compared. reference prices of in-patient medicines on reference prices and price agreements are available in the List of Health (where these exist); in other cases, If the price of a pharmaceutical is too high, Services. However, confidential risk or reimbursement is based on the product’s price negotiations with the manufacturer cost-sharing information is not publicly retail price. Price setting is incorporated are started. Pricing decisions for out- available. Moreover, discounts/rebates into the decision-making procedure for patient medicines are made by the Minister are not defined in legislation but within reimbursement. The country’s internal of Health and Labour, who receives advice price agreements. reference pricing system to determine the from a Pharmaceutical Committee and reference price for out-patient medicines

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Table 1: Performance-based and cost-sharing MEAs in Estonia, based on indication • Clinical and cost-effectiveness pricing: data comparison of Incremental Cost- International Non-Proprietary Effectiveness Ratio (ICER) per life Name (INN) Indication Managed entry agreement year/quality adjusted life year (QALY) Brentuximab Lymphoma Performance-based with corresponding data for medicines already included in the positive list. Mifamurtide Osteosarcoma Performance-based Telaprevir Hepatitis C Performance-based • MEAs: individual agreements between Goserelin Prostate cancer Cost-sharing the NHS and MAHs, such as price- volume agreements, were introduced in Triptorelin Prostate cancer Cost-sharing October 2012 as well as the possibility Bevacizumab Lung cancer Cost-sharing to cover patients’ co-payments (who Bevacizumab Ovarian cancer Cost-sharing receive reimbursement through Dabrafenib Melanoma Cost-sharing individual compensation). Although the reimbursement system Source: Ref 6 in Latvia operates under more limited financial resources than its neighbours Figure 2: Existing and potential MEAs in Latvia (see Figure 1), a wide spectrum of financial tools has been implemented in Managed entry agreements (MEAs) the reimbursement system and further measures are being investigated. MEAs, which are just one of these tools, limit Managing uncertainties Managing uncertainties Managing uncertainties the uncertainties that exist with the relating to budget impact relating to clinical relating to cost- introduction of new medicines with regard and prices evidence and eligible effectiveness patient population to clinical and economic evidence, fair price and budget impact as well as eligible patient population (see Figure 2). Financial based MEAs and E-Health Outcome based MEAs.: cost sharing arrangements: Patient registries: - Risk sharing Currently, Latvia uses financial-based - Budget capping - Neoplasms - Payment by results MEAs most frequently. For example, - Utilisation capping - Hepatitis C - Performance linked - Price/volume - Diabetes reimbursement taking into account the fixed annual - Discounts - Neurology - Coverage with evidence budget allocation for the reimbursement - Payback - Rare diseases etc. development system, a claw-back scheme was implemented for the period 2011 – 12, Source: Authors’ own. whereby MAHs, depending on their market share, had to partly compensate Latvia • External reference pricing: the the NHS if the annual medicines budget price of a medicine cannot be was exceeded. The claw-back system has Reimbursement procedures in Latvia higher than the third-lowest price been re-introduced in 2016 under certain allow patients to acquire medicines and (manufacturer/wholesaler) found conditions e.g. if the sales of specific medical devices, with the state completely in the Czech Republic, Denmark, medicines or medical devices – included or partially covering acquisitions through Romania, Slovakia and Hungary and in List B (non-interchangeable items), that national budget funds. Reimbursement cannot exceed the prices in Estonia have been reimbursed for at least three is determined by the type of disease and Lithuania. years – increase more than 10% from the and the degree of severity. 7 In order previous period (except where an MEA to include a medicinal product on the • Internal reference pricing (for medicines is signed). 7 positive list, the MAH submits a written with the same International Non- application to the National Health Service Proprietary Name (INN) or the same The number of MEAs has grown over (NHS) containing clinical information (a pharmacotherapeutic group) was the years and in 2015 there were 29 summary of the clinical trial evidence, introduced in 2005: the price must be price-volume agreements, four payback indications, patient target groups, etc.) at least 30% lower for the first generic/ agreements and one pay-for-performance and pharmacoeconomic information (in biosimilar medicinal product, 10% agreement in force. From 2016, outcome- accordance with the Baltic Guidelines for for the second and third, and 5% for based MEAs will increase in prominence, Economic Evaluation of Pharmaceuticals). further applications. The reference price including in treatment monitoring of Decisions are based on medical assessment for medicines with the same (equal) Hepatitis C with innovative medicines and economic evaluation. therapeutic efficacy is determined based and applying payment by results, based on on the price of the cheapest medicine patient registry data. The main elements in the pricing system in the reference group (originator or are as follows 7 : generic).

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Figure 3: Types of MEAs between the NHIF and the pharmaceutical industry • MEAs: individual agreements between in Lithuania, 2015 the National Health Insurance Fund (NHIF) and MAHs were introduced Managed entry agreements (MEAs) in 2007 and their numbers have increased in recent years from 20 MEAs in 2010 to 60 in 2013 to 108 in 2015. Price volume agreements (59) Payback Clinical outcome based MEAs take the form of price-volume agreements (47) agreements (2) agreements, payback agreements and clinical-outcome based agreements (see Figure 3). Pharmaceutical companies are The largest number of MEAs are signed The payback is Pharmaceutical companies required to pay the NHIF if for Antineoplastic and immunomodulating expenditure for the medicines calculated at the are required to pay the end of each quarter NHIF if treatment is covered by the Agreements agents (group L of the ATC) (47.6% of ineffective total MEAs), followed by the Nervous exceed the amount that was estimated in the price volume system (N) (9.5%), Alimentory tract and agreement metabolism (A) (8.6%), Blood and blood forming organs (B) (8.6%), Antiinfectives for systemic use (J) (7.6%), Cardiovascular Source: Ref 4 system (C) (4.8%), Respiratory system (R) (4.8%), Systemic hormonal preparations The policy goal of MEAs is to encourage for inclusion to the positive list are the OPINION (excluding sex hormones and analogues the entry of new medicines onto the product’s budgetary impact, therapeutic (H) (3.8%), Musculo-sceletal system (M) market. At same time, there are some value and pharmacoeconomic value. (2.9%), Sensory organs (S) (0.9%) and risks for countries, like Latvia, with low Various (V) (0.9%). 4 purchasing power: The main pricing mechanisms used for reimbursed medicines in Lithuania are 4 : • New innovative medicines initially References: are launched in countries with high • External reference pricing: prices levels purchasing power and their prices are are compared with eight reference 1 WHO Regional Office for Europe. Access to set according to the purchasing power countries (Bulgaria, Czech Republic, new medicines in Europe: technical review of policy initiatives and opportunities for collaboration and of the wealthiest European Union (EU) Estonia, Hungary, Latvia, Poland, research. Copenhagen: World Health Organization, countries. Slovakia and Romania) and 95% 2015. Available at: http://apps.who.int/ of the average price in reference medicinedocs/documents/s21793en/s21793en.pdf • Confidential agreements can countries is used to calculate the base 2 decrease competition on the prices of Ferrario A, Kanavos P. Managed entry agreements (reimbursed) price. innovative medicines. for pharmaceuticals: the European experience. Brussels: European Medicines Information Network • Internal reference pricing and • Agreements for confidential discounts (EMINET), 2013. Available at: http://eprints.lse. clustering: on the basis of INN, are mostly influenced by the external ac.uk/50513/ pharmaceutical form (e.g. soft, solid, price reference systems, which exist 3 Baltic Guidelines for Economic Evaluation of injectable), method of use, purpose and in almost all EU countries, and Pharmaceuticals (Pharmacoeconomic Analysis). method of release of active substance. significantly decrease the transparency Available at: http://www.ispor.org/peguidelines/ Interchangeable pharmaceuticals with source/Baltic-PE-guideline.pdf of pricing as they hide real prices. a different INN (since 2010) can be 4 Materials for the twelfth Baltic Policy Dialogue. Lithuania clustered according to therapeutic Organised by the World Health Organization in effect, indication of reimbursement, collaboration with the Ministry of Health of the Lithuania’s health care system serves presentation form and age groups Republic of Latvia in partnership with the European the entire population, and all permanent of patients. Observatory on Health Systems and Policies. Riga, 2015. residents are required to participate in • Generic pricing: the first generic has 5 the compulsory health insurance scheme. Estonian State Medicines Agency, Latvian State to be priced 50% below the originator, Compulsory health insurance provides Medicines Agency, Lithuanian State Medicines while the second and third generics Control Agency. Baltic Medicines Statistics 2010 – a standard benefits package for all must be priced at least 15% below 2012. Tartu: ESAM, 2013. Available at: https://www. beneficiaries. Medicines prescribed by the first generic to be reimbursed zva.gov.lv/doc_upl/BS_2013.pdf a physician are reimbursed according to (until 2014, the pricing levels were 30%, 6 Estonian Health Insurance Fund. Managed entry a positive list. 5 10% and 10% below, respectively). If agreements applied in Estonia. Riga, 2016. the INN is produced by four or more 7 Outpatient pharmaceuticals are reimbursed Regulation No. 899 of the Cabinet of Ministers producers, the most expensive medicinal of the Republic of Latvia. Procedures for the according to a list of defined diseases, with product cannot exceed the price of the Reimbursement of Expenditures for the Acquisition of the reimbursement category depending cheapest one by more than 30%. Medicinal Products and Medicinal Devices Intended on the severity of the disease. Criteria for Out-patient Medical Treatment. 31 October 2006, with amendments. Available at: http://www.likumi.lv/ doc.php?id=147522

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WHAT, IF ANYTHING, DOES THE EURO HEALTH CONSUMER INDEX ACTUALLY TELL US?

By: Jonathan Cylus, Ellen Nolte, Josep Figueras and Martin McKee

Since 2005, the Health Consumer Powerhouse has produced its annual Euro Health Consumer Index,[1] ranking European health systems according to their performance [2] on a host of indicators

OPINION around (i) patient rights and information, (ii) accessibility, (iii) outcomes, (iv) range and reach of services, (v) prevention and (vi) pharmaceuticals. In its most recent iteration, the United Kingdom ranked only 14th of 35 countries studied. This is in stark contrast to the assessment by the Commonwealth Fund just a year before, in which the UK was rated as the best performing health system among a set of high-income countries in 2014.[3]

While we understand the excitement this measure, despite its high levels of surrounding health system rankings, deductibles and out-of-pocket spending we caution against over-interpreting as a share of total expenditure that is them and, especially, the Euro Health twice the EU-15 average, along with high Consumer Index which, as we will show, levels of unmet need compared to other is especially problematic. countries and many peer-reviewed studies concluding that the Swiss financing 4 Arbitrary scores are given to system is regressive. indicators The point system does not reflect The index is constructed by scoring what matters to citizens performance in the five areas listed above as good (3), intermediary (2) There is no obvious logic in how many or not-so-good (1), based on arbitrary points are allocated to each indicator. For cut-off points. Consequently, countries example, all health outcomes indicators Acknowledgement: with similar performance will receive are worth a total of 250 points, while Reprinted by permission of very different scores if they are just accessibility is worth 225 points. Yet there The BMJ. Originally published online on 9 February 2016. on either side of the cut-off point. For are more outcome indicators (8) than example, Poland scores not-so-good accessibility indicators (6), so that the on “equity of health care systems” maximum score on any given accessibility because only 69.6% of health care is metric (e.g. waiting time) will be higher Jonathan Cylus, Ellen Nolte, Josep Figueras and Martin McKee, publicly funded. Yet Slovakia receives an than on an outcome metric (37.5 compared European Observatory on Health intermediate score as it achieves 70.0% to 31.25 points). Thus, not only do abortion Systems and Policies, Brussels and (a whopping 0.4 percentage points more). rates and cancer survival carry the same London. Email: [email protected] Switzerland earns a “good” score on weight (since both are considered health

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outcomes) but an outcome indicator seen this figure increase by 2.8 percentage There is great potential for countries to like cancer survival counts less than an points in the same period (from an learn from each other through careful accessibility indicator like direct access to admittedly low level, at just 3.5% in 2013) comparison but the Euro Health Consumer a specialist. but still receive the maximum points. Index’s use of poorly constructed composite indices of uncertain origin is This seemingly indiscriminate approach Conclusion: We should just ignore the unlikely to inform any evidence-based to allocating points also means that findings of the Euro Health Consumer policy development. countries can accumulate similar points Index by prioritising different issues, even if References these are unlikely to be seen as equivalent While many other health systems rankings by citizens, had they been asked. For that have been widely criticised, such as 1 Euro Health Consumer Index 2015. example, a hypothetical country coming the 2000 World Health Report, these are Available at: http://www.healthpowerhouse.com/ files/EHCI_2015/EHCI_2015_report.pdf last on cancer survival and infant deaths far more transparent, methodologically, earns approximately 10.4 points for each than the Euro Health Consumer Index. 2 Watson R. Netherlands tops European healthcare indicator (out of a possible 62.5 total Yet, there is no “right” way to rank health index. BMJ 2016;352:i538. Available at: http://www. bmj.com/content/352/bmj.i538 points) leaving around a 41.6 point deficit. systems, or any other complex system Rather than investing in improving these for that matter. Choices must be made 3 Davis K, Stremikis K, Squires D, Schoen C. outcomes, it could just compensate for this regarding the indicators to be assessed and Mirror, mirror on the wall: How the performance of the US health care system compares internationally. simply by abolishing gatekeeping, since the values to attribute to them. However, New York: Commonwealth Fund, 2014. Available at: allowing direct access to a specialist can the notion that we can (or should!) rank http://www.commonwealthfund.org/~/media/files/ gain 37.5 points), which may 6 or may not 7 health systems based on a single measure publications/fund-report/2014/jun/1755_davis_ improve outcomes on these measures. that seemingly haphazardly combines mirror_mirror_2014.pdf indicators that have been “scored” what 4 De Pietro C, Camenzind P, Sturny I, et al. seems to be at random is debatable. Switzerland: Health system review. Health Systems There is no apparent basis for in Transition 2015;17(4):1–288. Available at: selecting the indicators Composite indices conceal what is actually going on in health systems, and offer little http://www.euro.who.int/en/about-us/partners/ observatory/publications/health-system-reviews- Lastly, the indicators are a strange mix guidance for policymakers who want to hits/full-list-of-country-hits/switzerland-hit-2015 of trends over time and cross-sectional improve the performance of their system. 5 rankings. For example, heart disease and The world health report 2000 – Health systems: improving performance. Geneva: World Health stroke deaths are measured as changes Although the report accepts that its Organization, 2000. Available at: http://www.who.int/ over time, whereas hospital-acquired results are not “dissertation quality” whr/2000/en/ infections use the most recent data point, and must be treated “with caution” it 6 Hawkes N. The role of NHS gatekeeping in delayed penalising countries showing substantial draws inappropriate conclusions about diagnosis. BMJ 2014;348:g2633. Available at: http:// improvements, such as the United the superiority of one system versus www.bmj.com/content/348/bmj.g2633 Kingdom where the percent of hospital- another one, leading to uninformed 7 Olesen F. Re: The role of NHS gatekeeping in acquired infections being resistant has recommendations and assertions that delayed diagnosis. 27 April 2014, Available at: http:// fallen from 21.6% in 2010 to 13.8% display limited understanding of health www.bmj.com/content/348/bmj.g2633/rr/695920 in 2013. Others, such as Estonia, have systems. This is patently irresponsible.

Luxembourg: Health system countries and lacks capacity to train health personnel, with shortages in some specialty care, which also necessitates review in brief a generous policy towards receiving care abroad. Reforms in 2008 and 2010 have targeted these challenges By: F Berthet, A Calteux, M Wolter, L Weber, E van Ginneken, by establishing a single health insurance fund envisioned A Spranger to play a stronger role in cost-containment and introducing Copenhagen: World Health Organization 2015 (acting as the e-health. There is also room for host organization for, and secretariat of, the European efficiency gains, especially in Observatory on Health Systems and Policies). hospital care. Current reforms aim to implement a national structured Number of pages: 18 health information system for Freely available for download at: www.euro.who.int/__data/ hospital services, which is a assets/pdf_file/0006/287943/Mini-HiT_Luxembourg-rev1. prerequisite to further announced pdf?ua=1 reforms such as the introduction of a diagnosis-related groups based The Luxembourgish health system has the highest per capita payment system. health spending in purchasing power parity amongst European

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NEW PUBLICATIONS

Strengthening health system governance: Ensuring innovation in diagnostics for bacterial better policies, stronger performance infection: implications for policy

Edited by: SL Greer, M Wismar and J Figueras Authors: C Morel, L McClure, S Edwards, V Goodfellow, D Sandberg, J Thomas and E Mossialos Maidenhead: Open University Press, 2015 Copenhagen: Observatory Studies Series No. 44, 2016 Number of pages: xiv + 272; ISBN: 978 0 3352 6134 5 Number of pages: xvi + 317; ISBN: 978 92 890 5036 4 Available for purchase at: http://www.mheducation.co. uk/9780335261345-emea-strengthening-health-system- Freely available for download at: http://www.euro.who. governance-better-policies-stronger-performance int/__data/assets/pdf_file/0008/302489/Ensuring-innovation- diagnostics-bacterial-infection-en.pdf?ua=1 This book provides a robust framework that identifies five key aspects of governance, distilled from a large body of literature, The inappropriate use of antibiotics is a primary cause of the that are important in explaining the ability of health systems to ongoing increase in drug resistance amongst pathogenic bacteria. provide accessible, high-quality, sustainable health: transparency, The resulting decrease in the accountability, participation, organisational integrity and policy efficacy of antibiotics threatens capacity. Part 1 of this book explains the significance of this the ability to combat infectious framework, drawing out strategies for health policy success diseases. Rapid, point-of-care and lessons for more effective governance: tests to identify pathogens and better target the appropriate • transparency, accountability, participation, integrity and treatment could greatly improve capacity are key aspects of health governance and shape the use of antibiotics, yet few decision making and implementation; such tests are available or • there is no simply good governance that can work everywhere: being developed, despite the every aspect of governance involves costs and benefits, and rapid pace of medical context is crucial; innovation. Clearly, something • governance can explain policy success and failure, so it should is inhibiting the much-needed be analysed and in some cases changed as part of policy development of new and formation and preparation; and more convenient diagnostic • some policies simply exceed the governance capacity of their tools. systems and should be avoided. This study delineates priorities for developing diagnostics to Part 2 explores eight case studies, applying the framework to improve antibiotic prescription and use, in order to manage and a range of themes. curb the expansion of drug resistance. It calls for new approaches, particularly in the provision of diagnostic devices, and, in doing so, This book is designed for health outlines some of the inadequacies in health, science and policy policy-makers and all those initiatives that have led to the dearth of such devices. The authors working or studying in the areas make the case that innovation is clearly and urgently needed, of public health, health research not only in the technology of diagnosis but also in public policy or health economics. and medical practice to support the availability and use of better diagnostic tools.

This book explores the complexities of the diagnostics market from the perspective of both supply and demand, unearthing interesting bottlenecks: some obvious, some more subtle. It calls for a broad, multifaceted policy response, and an overhaul of current practice, so that the growth of bacterial resistance can be stemmed.

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NEWS

International Framework for Action on Mental Health and ECOFIN ministers agree to consider Wellbeing, the most important outcome of health and care issues, particularly EU launches new European Medical this initiative. in the Euro area Corps to respond faster to emergencies According to situational analyses In Brussels on 11th February Economic made by the Joint Action, significant On 15th February the EU launched the and Finance Ministers agreed that it would advances have taken place in Europe European Medical Corps to help mobilise be important to make public spending in public mental health in recent years. medical and public health teams and more efficient to enhance the Euro area’s Yet, important challenges remain to equipment for emergencies inside and potential for economic growth. They agreed be effectively addressed and in most outside the EU. Through the Corps, to further discuss specific areas of public countries mental health policies have EU Member States and other European spending. The Eurogroup will pay particular not been fully implemented. Enhanced countries participating in the system can attention to investment, health care and efforts and new strategies are, therefore, make medical teams and assets available ageing-related expenditure at upcoming needed to improve the implementation of for rapid deployment before an emergency Eurogroup meetings. The discussion policies aiming at the provision of essential strikes – thus ensuring a faster and more was based on a study conducted by the mental health care for the most prevalent predictable response. The medical corps European Commission to assess the mental disorders and the development of could include emergency medical teams, composition, efficiency and effectiveness of preventive and promotion interventions. public health and medical coordination the euro area’s government expenditure in Thus, the European Framework for Action experts, mobile biosafety laboratories, fields such as education, health care, and on Mental Health and Wellbeing has five medical evacuation planes and logistical research and development. main objectives: support teams. More information at: http://www. 1. Ensure the setup of sustainable and The framework for the European Medical consilium.europa.eu/en/meetings/ effective implementation of policies Corps is part of the EU Civil Protection eurogroup/2016/02/11/ contributing to promotion of mental Mechanism’s new European Emergency health, prevention and treatment of Response Capacity (otherwise known as mental disorders. the ‘voluntary pool’). So far Belgium, Czech Superbugs: curb use of today’s Republic, Finland, France, Luxembourg, 2. Develop mental health promotion antibiotics, and develop new ones, urge Germany, Spain, Sweden and the and prevention programmes through MEPs Netherlands have already committed teams integration of mental health in all policies and equipment to the voluntary pool. and multi-sectoral cooperation. The European Centre for Disease Control (ECDC) recently warned that bacteria Humanitarian Aid and Crisis Management 3. Ensure transition to comprehensive in humans, food and animals continue Commissioner Christos Stylianides said mental health care in the community, to show resistance to the most widely- that “the aim is to create a much faster emphasising the availability of mental used antimicrobials. Scientists say that and more efficient EU response to health health care for people with common resistance to Ciprofloxacin, an antimicrobial crises when they occur. We need to learn mental disorders, coordination of health that is critically important for the treatment the lessons from the Ebola response; a key and social care for people with severe of human infections, is very high in difficulty was mobilising medical teams”. mental disorders, as well as integrated Campylobacter, thus reducing the options care for mental and physical disorders. More information on the European Medical for effective treatment of severe foodborne Corp at: http://europa.eu/rapid/press- 4. Strengthen knowledge, the evidence infections. Multi-drug resistant Salmonella release_MEMO-16-276_en.htm base and good practice sharing in bacteria continue to spread across Europe. mental health To fight the growing resistance of bacteria 5. Partnering for progress. to today’s antibiotics, the use of existing European Framework for Action on antimicrobial drugs should be restricted, Mental Health and Wellbeing and new ones should be developed, More information on the conference at: http:// said Environment and Public Health The Final Conference of the Joint Action on www.jamhwbfinalconference.admeus.net/ Committee MEPs on 17th February. In a Mental Health and Wellbeing (JA MH-WB), The Framework document and other vote on draft plans to update an EU law held in Brussels on 21 – 22nd January 2016, publications for the joint action are available on veterinary medicines, they advocated presented the opportunity to discuss at: http://www.mentalhealthandwellbeing. banning collective and preventive antibiotic progress made over the past three years eu/publications treatment of animals, and backed and to hold a debate on the European measures to stimulate research into new medicines.

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The objectives of the legislative proposal In a separate vote, the committee Informing policy for young people’s on antimicrobials are interlinked. It aims approved by 53 votes to three a report health to increase availability of veterinary by Claudiu Ciprian Ta˘ na˘ sescu (S&D, RO), medicinal products; reduce administrative amending another law to reflect the fact On 15th March the 2016 edition of the burdens; stimulate competitiveness and that centralised marketing authorisation WHO Health Behaviour in School-aged innovation; improve functioning of the for veterinary medicinal products is being Children (HBSC) study was published. internal market; and address the public decoupled from that for medicines for The report ‘Growing up unequal: gender health risk of antimicrobial resistance humans. Both reports are being debated and socioeconomic differences in (AMR). The revised law would empower and will be put to a vote during the March/ young people’s health and well-being’, the European Commission to designate April plenary sessions in Strasbourg. covers the 2013/2014 survey on the antimicrobials which are to be reserved for demographic and social influences on the More information on the report and proposed human treatment. health of almost 220,000 young people amendments at: http://tinyurl.com/zbwuago in 42 countries and regions in the WHO “The vote is a big step forward for animal European Region and North America. health and the fight against antibiotic resistance. With these new rules, we can EPFPSU: European and national policies The report is the latest addition to a series better circumscribe and control the use must strengthen public health care of reports on the HBSC study: a WHO of antibiotics in farm animals and thus systems collaborative cross-national study that has reduce the risk that potential resistances provided information about the health, will emerge. The text will also help to How can Europe ensure good quality well-being, social environment and health improve the availability of medicines and health care for all and counter increasing behaviour of 11-, 13- and 15-year-old boys drive innovation forward, so as to expand pressures brought about by under- and girls for over 30 years. Young people the therapeutic arsenal available to vets. investment and lack of cooperation described their social context (relations with I welcome the broad consensus on this amongst different health care systems? family, peers and school), health outcomes report, which should promote public health This question was a central theme of the (subjective health, injuries, obesity and and consumer protection”, said lead MEP European Federation of Public Service mental health), health behaviour (patterns Françoise Grossetête (EPP, FR). Her report Union’s (EPSU) standing committee for of eating, tooth brushing and physical was approved by 60 votes to two. health care and social services (HSS) activity) and risk behaviours (use of that met on 16 February. Some 60 tobacco, alcohol and cannabis, sexual Veterinary medicines must not under representatives from 25 countries took behaviour, fighting and bullying). For the any circumstances serve to improve part in the meeting. first time, the report also includes items performance or compensate for poor on family and peer support, migration, animal husbandry, say MEPs, who A special focus was given to challenges cyberbullying and serious injuries. advocate limiting the prophylactic use of facing health care unions in Romania antimicrobials (i.e. as a preventive measure, and Bulgaria. Against a backdrop of a The report and further information are in the absence of clinical signs of infection) continuing exodus of trained health care available at: http://tinyurl.com/zh77dmp to single animals and only when fully workers to wealthier parts of Europe, the justified by a veterinarian. Metaphylactic meeting noted that unions struggle to use (i.e. treating a group of animals when build up a stable trade union membership Warning on TB elimination in Europe one shows signs of infection) must be base that could more effectively address restricted to clinically-ill animals and to these challenges. Many participants The eighth report launched jointly by ECDC single animals that are identified as being mentioned difficulties with ensuring safe and the WHO Regional Office for Europe at a high risk of contamination, in order to and adequate staffing levels in health indicates that, despite notable progress prevent bacteria from spreading further in care. The EPSU consider that trends in the past decade, tuberculosis (TB) the group, they say. regarding the privatisation, marketisation is still a public health concern in many and commercialisation of health (and European countries. An estimated 340,000 MEPs urge farm animal owners and social) care run counter to the need to Europeans had tuberculosis (TB) in 2014, keepers to use stocks with suitable increase funding in public systems and to corresponding to a rate of 37 cases genetic diversity, in densities that do not step up coordination and cooperation of per 100,000 population. increase the risk of disease transmission, polices across Europe to ensure universal and to isolate sick animals. To encourage The organisations warn that although access to high quality healthcare. They research into new antimicrobials, MEPs new TB cases decreased by 4.3% on affirmed their belief that well-funded and also advocate incentives, including average between 2010 and 2014, high democratically controlled health care longer periods of protection for technical rates of multidrug-resistant (MDR) TB and systems are extremely efficient when documentation on new medicines, TB in vulnerable populations, such as the compared to these where market forces commercial protection of innovative active homeless, drug and alcohol abusers and are allowed to play too big a role. substances, and protection for significant migrants from countries with high numbers investments in data generated to improve More information at: of cases of TB continue to challenge an existing antimicrobial product or to keep http://www.epsu.org/a/12042 TB elimination. it on the market.

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“One quarter of all 480,000 patients sick provided that there is no tension with the “This measure is supported by a majority with MDR-TB globally were in the European public; of the 75% of workers who were of the public and sends a clear signal Region in 2014. This alarmingly high reportedly in contact with the public by to industry that the public’s health is a number is a major challenge for TB control,” phone or in person, 10% reported such key part of the economic recovery. FPH stated Dr Zsuzsanna Jakab, WHO Regional tensions. Exposure to psychosocial risks congratulates the government for accepting Director for Europe. “The most vulnerable was also found to increase the risk of the strong, evidence-based argument that groups, including poor and marginalised occupational accidents and absenteeism, this will have a positive effect on the lives populations and migrants and refugees, are especially for men who report a lack of the population.” at greater risk of MDR-TB. Because of their of recognition. Mr Osborne said that the tax would raise living conditions, TB is often diagnosed The SUMER survey is a unique survey an estimated £520m a year to spent on late, and it is harder for them to complete based on interviews of occupational sport in primary schools. The devolved a treatment course. If we really want to physicians with workers who undergo administrations in Northern Ireland, eliminate TB from Europe, no one must health surveillance and has been Scotland and Wales will have to decide be left behind.” carried out in three waves (1994, 2003 how to spend their share of the proceeds. “Some social circumstances or lifestyles and 2010). It covers a broad range of risks, may make it more difficult for people to including chemical, biological, physical recognise the symptoms of TB, access and organisational risk factors. The next UK: Healthier in the EU group established health care services, follow treatment or survey is currently in preparation. attend regular health care appointments. The United Kingdom government’s The report is available in French at: We need to find tailored interventions for decision to hold a referendum on European http://tinyurl.com/jox65sr such vulnerable people, which can include Union (EU) membership has generated outreach teams or directly observed much, largely uniformed, debate. One treatment,” commented ECDC Acting important issue is the impact of the EU UK: New sugar tax on soft drinks Director Dr Andrea Ammon. on health and health policy in the UK. A announced new grassroots movement, Healthier in Tuberculosis surveillance and monitoring the EU, has been launched, with the goal in Europe 2016 is available at: The UK Minister of Finance, George of correcting misconceptions that are http://tinyurl.com/zuq9ewc Osborne, has announced in his annual circulating. Its advisory board has some budget statement to Parliament that a new of the UK’s leading health professionals, sugar tax on soft drinks that will come into including a former Scottish Chief Medical effect from 2018. A levy will have to be Officer, President of the Royal College paid by the drinks industry. It will provide National of Physicians, and Chief Executive of the an incentive to cut the amount of sugar in NHS in England, as well as experts in EU France: Work organisation challenged by drinks. The industry may decide instead to law and health policy, nursing, and the psychosocial risks raise the prices of their products. editor of the Lancet. The organisation’s Drinks with 5 grams (g) of sugar per 100 website includes statements by health The most recent publication of the SUMER millilitre (ml) will incur an £0.18 (€0.21) professionals on the importance of the EU survey focuses on psychosocial and per litre levy and drinks with 8g or more for the NHS and public health, ranging from organisational risks, investigated using per 100ml will incur a £0.24 (€0.27) the obvious, such as sharing of expertise workplaces stress models developed by per litre levy. Given that soft drink cans on rare diseases, biomedical research, Robert Karasek and Johannes Siegrist. contain 330ml of liquid, drinks in the upper and the ability of British patients to obtain The initial results indicate that job strain band could be 8p (€0.09) more expensive access to care throughout Europe, to impacts more on women because of their per can, a small bottle could be 12p (€0.14) the less obvious, such as how UK health lower job autonomy and opportunity to more and a 1.75-litre bottle could cost professionals were able to achieve shape the work they do, for example the around 40p (€0.45) more. Natural fruit concerted European action to restrict the pace of work. juices with no added sugar, as well as milk- use of medicines in executions in the USA. Administrative staff, unskilled, trade and based drinks, will be exempt from the tax. More information at: http://healthierin.eu/ service workers are more often reporting to Gavin Partington, Director General of be “tense”, due to a combination of strong the British Soft Drinks Association said psychological demands with low decision that they were “extremely disappointed Additional materials supplied by: latitude. Men who exercise functions by the Government’s decision to hit the EuroHealthNet Office predominantly occupied by women are only category in the food and drink sector 67 rue de la Loi, B-1040 Brussels most affected by the lack of recognition which has consistently reduced sugar Tel: + 32 2 235 03 20 of their work. intake in recent years – down 13.6% Fax: + 32 2 235 03 39 The health care sector is particularly since 2012. In contrast Professor John Email: [email protected] exposed to psychosocial risks. In contrast, Ashton, President of the UK Faculty of working in direct contact with the public Public Health (FPH) warmly welcomed was found to be a protective factor, the announcement.

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10th ANNIVERSARY OBSERVATORY VENICE SUMMER SCHOOL 2016

Primary care: innovating for integrated, more effective care

24 – 30 July 2016 Isola di San Servolo, Venice, Italy.

Theme and objectives A one-week intensive course aimed at senior and mid-level policy makers, civil servants and professionals steering primary care services and those looking at strengthening care, its continuity and Approach How to apply integrative functions within and beyond The School will equip participants to: Submit your CV and application form the health system. before 31 May 2016. • Investigate different organisational Building on participants’ own knowledge models for delivering primary Summer School’s fee: €2,200 (including and expertise, the School will: care (including public and private teaching material, accommodation, provision); meals, social programme, and transfers • Systematise and interpret primary between the airport and the island upon care reform innovations and their Coordinate different professionals with • arrival/departure). implementation; an appropriate skill mix to best meet patients’ needs; More information and on-line • Provide tools to assess the application on our website: performance of primary care systems; Apply tools, frameworks and different • www.theobservatorysummerschool.org approaches to better support and • Explore a series of innovations that can integrate different population groups, help to strengthen effectiveness; including persons in vulnerable • Address how integrative and integrated situations; primary health care systems can WE AWAIT YOU IN VENICE! Use technological innovations and serve whole populations, including • information system developments to Organised by the European Observatory vulnerable groups; support more effective primary care on Health Systems and Policies, the • Address the integration between and better integration; Veneto Region of Italy, the European health care, public health and social Commission and the World Health Empower patients and make primary services; • Organization. care the guide which advises patients • Provide evidence-based country in their path through the health system, experiences of different systems and and supports them in exercising choice innovative models of primary care; and accessing the right services in the right settings at the right time; • Review how provider payments and incentives can ensure primary • Integrate public health services into care fulfills its potential and works primary care. effectively with other sectors.