Eurohealth RESEARCH•DEBATE•POLICY•NEWS Volume 15 Number 1, 2009

Chronic disease management and remote patient monitoring

Chronic disease management in Europe and the US

Clinical and economic perspectives on remote patient monitoring

Adopting mainstream telecom services: lessons from the UK

Cross-border health care: implications for NHS • Norway: improving child and adolescent mental health services Promoting a sustainable workforce • Pharmaceutical sector in Srpska • South Korea: long term care insurance Chronic disease management and the Eurohealth

use of remote patient monitoring LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK Chronic diseases, such as heart disease and diabetes, have fax: +44 (0)20 7955 6090 C http://www.lse.ac.uk/collections/LSEHealth substantial health and economic impacts. Routine con- sultations to monitor these conditions place a consider- Editorial Team able strain on health service resources. Consequently, EDITOR: there has been an increased interest in utilising informa- David McDaid: +44 (0)20 7955 6381 email: [email protected] tion technology to help manage patients. One such inno- vation – the use of remote monitoring – allows for the FOUNDING EDITOR: O Elias Mossialos: +44 (0)20 7955 7564 collection of routine information on the health status of email: [email protected] individuals outside the doctor’s office and is the focus of DEPUTY EDITORS: much of this issue of Eurohealth. Sherry Merkur: +44 (0)20 7955 6194 Philipa Mladovsky: +44 (0)20 7955 7298

Chronic disease management (CDM) encompasses the ASSISTANT EDITORS: M ongoing management of chronic conditions over a period Azusa Sato +44 (0)20 7955 6476 of time using evidence-based care. In an article on CDM email: [email protected] Lucia Kossarova +44 (0)20 7107 5306 in the US, Kenneth Thorpe highlights the huge burden of email: [email protected] chronic disease in terms of mortality and health care EDITORIAL BOARD: spending. He calls for prevention efforts directed at Reinhard Busse, Josep Figueras, Walter Holland, patient education, improved coordination among practi- Julian Le Grand, Martin McKee, Elias Mossialos M tioners and better patient-doctor collaboration. In their SENIOR EDITORIAL ADVISER: article on CDM in Europe, David Scheller-Kreinsen and Paul Belcher: +44 (0)7970 098 940 colleagues, present key strategies used to manage chronic email: [email protected] diseases, summarising existing evidence on their effec- DESIGN EDITOR: Sarah Moncrieff: +44 (0)20 7834 3444 tiveness and describing common obstacles to effective email: [email protected] CDM. SUBSCRIPTIONS MANAGER E Champa Heidbrink: +44 (0)20 7955 6840 Four articles specifically address remote monitoring. In email: [email protected] their article on the clinical perspective, Jillian Riley and Advisory Board Martin Cowie contrast traditional models of CDM with Tit Albreht; Anders Anell; Rita Baeten; Johan Calltorp; Antonio the inclusion of remote monitoring in a heart failure Correia de Campos; Mia Defever; Isabelle Durand-Zaleski; population, presenting both the clinical benefits and Nick Fahy; Giovanni Fattore; Armin Fidler; Unto Häkkinen; patient perspective. Paul Trueman tackles the economic Maria Höfmarcher; David Hunter; Egon Jonsson; Meri N Koivusalo; Allan Krasnik; John Lavis; Kevin McCarthy; Nata perspective, describing the potential benefits of remote Menabde; Bernard Merkel; Willy Palm; Govin Permanand; Josef monitoring and commenting on the growing body of Probst; Richard Saltman; Jonas Schreyögg; Igor Sheiman; Aris Sissouras; Hans Stein; Ken Thorpe; Miriam Wiley evidence on the clinical and cost effectiveness of such interventions. Michael Palmer and colleagues look at the Article Submission Guidelines European Commission’s adoption of a Communication see: www.lse.ac.uk/collections/LSEHealth/documents/ to support the deployment of telemedicine for the bene- eurohealth.htm

T fit of patients, health care systems and society. Finally, Published by LSE Health and the European Observatory on James Barlow and Jane Hendy use the case of the UK to Health Systems and Policies, with the financial support of present the challenges of adopting integrated mainstream Merck & Co and the European Observatory on Health Systems and Policies. This issue has been supported by an unrestricted telecare services. A common thread running through educational grant by Medtronic International Trading SARL. these Eurohealth is a quarterly publication that provides a forum for contributions are the challenges in providing appropriate researchers, experts and policymakers to express their views on incentives for health care professionals to implement health policy issues and so contribute to a constructive debate on health policy in Europe. changes to improve chronic care, including the use of The views expressed in Eurohealth are those of the authors telemedicine. alone and not necessarily those of LSE Health, Merck & Co., the European Observatory on Health Systems and Policies or Other features in this issue include two perspectives Medtronic International Trading SARL. from the European Commission. One discusses the EU The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Directive on patients’ rights in cross-border health care Office for Europe, the Governments of Belgium, Finland, Nor- and its implications for the National Health Service in way, Slovenia, Spain and Sweden, the Veneto Region of Italy, the the UK. The second focuses on the EU Green Paper on European Investment Bank, the World Bank, the London School of Economics and Political Science, and the London the health care workforce, which is intended to support School of Hygiene & Tropical Medicine. Member States as they confront an ageing but © LSE Health 2009. No part of this publication may be copied, re- increasingly mobile population. produced, stored in a retrieval system or transmitted in any form without prior permission from LSE Health.

Sherry Merkur Deputy Editor Design and Production: Westminster European David McDaid Editor Printing: Optichrome Ltd Philipa Mladovsky Deputy Editor ISSN 1356-1030 Contents Eurohealth Volume 15 Number 1

Chronic disease management Marian Ådnanes is Senior Research Scientist, SINTEF Health Research, Trondheim, Norway. 1 Chronic disease management in Europe David Scheller-Kreinsen, Miriam Blümel and Reinhard Busse James Barlow is a Professor of Technology and Inno- vation Management at Imperial College Business 5 Chronic disease management and prevention in the US: School, London, UK The missing links in health care reform Miriam Blümel is Research Fellow at the Department Kenneth E Thorpe for Health Care Management, Berlin University of Technology, Germany. 8 Adopting integrated mainstream telecare services Helena Bowden is European Policy Manager, NHS Lessons from the UK European Office, Brussels, Belgium. James Barlow and Jane Hendy Reinhard Busse is Professor and Department Head at 10 Economic considerations of remote monitoring in chronic conditions the Department for Health Care Management, Berlin Paul Trueman University of Technology, Germany. Martin Cowie is Professor of Cardiology at Imperial 13 European Commission perspective: Telemedicine for the benefit of College, London, UK. patients, health care systems and society Flora Giorgio is based at the ICT for Health Unit, DG Michael Palmer, Christoph Steffen, Ilias Iakovidis and Flora Giorgio Information Society and Media, European 15 A clinical perspective on remote monitoring of chronic disease Commission, Brussels, Belgium. Jillian P Riley and Martin R Cowie Nataša Grubiša is a pharmacist at the Drug Regu- latory Agency of Republic of Srpska, Banja Luka, Bosnia and Herzegovina. Health Policy Developments Jane Hendy is a Research Fellow at Imperial College Business School and a member of HaCIRIC. 18 EU cross-border health care proposals: implications for the NHS Ilias Iakovidis is based at the ICT for Health Unit, DG Helena Bowden Information Society and Media, European Commission, Brussels, Belgium. 20 Promoting a sustainable workforce for health in Europe Elizabeth Kidd Elizabeth Kidd is based at the Health Strategy Unit, European Commission, Brussels, Belgium. She is on 23 The pharmaceutical sector in the Republic of Srpska, Bosnia and secondment from the Department of Health. Herzegovina Soonman Kwon is Professor of Health Economics and Vanda Markovic Pekovi´c, Ranko Skrbi´cand Nataša Grubiša Policy, School of Public Health, Seoul National University, South Korea. Michael Palmer is based at the ICT for Health Unit, DG Snapshots Information Society and Media, European Commission, Brussels, Belgium. 26 Improving child and adolescent mental health services in Norway: Vanda Markovic Pekovi´c is a pharmacist based at the Policy and results 1999–2008 Ministry of Health and Social Welfare, Republic of Marian Ådnanes and Vidar Halsteinli Srpska, Banja Luka, Bosnia and Herzegovina. Jillian Riley is Head of Postgraduate Education (Nurses 28 The introduction of long-term care insurance in South Korea and Allied Professionals) at the Royal Brompton & Soonman Kwon Harefield NHS Trust, London, UK. David Scheller-Kreinsen is Research Fellow at the Department for Health Care Management, Berlin Evidence-informed Decision Making University of Technology, Germany. 30 “Bandolier” Value of vision Ranko Skrbi´c is Minister of Health and Social Welfare, Republic of Srpska, Bosnia and Herzegovina. 32 “Risk in Perspective” An overview of “Science and decisions: advancing risk assessment” Christoph Steffen is based at the ICT for Health Unit, DG Information Society and Media, European Commission, Brussels, Belgium. Kenneth E Thorpe is Robert W. Woodruff Professor and Chair, Department of Health Policy and Monitor Management, Rollins School of Public Health, Emory 37 Publications University, Atlanta, USA. Paul Trueman is Director of the York Health Economics Web Watch 38 Consortium, University of York, UK. 39 News from around Europe Vidar Halsteinli is Research Scientist, SINTEF Health Research, Trondheim, Norway. CHRONIC DISEASE MANAGEMENT Chronic disease management in Europe

David Scheller-Kreinsen, Miriam Blümel and Reinhard Busse

Summary: Chronic conditions and diseases are the leading cause of mortality and morbidity in Europe. Managing chronic diseases has therefore become a health policy priority in many European countries. However, current approaches face substantial problems. This article briefly presents the main strategies to manage chronic diseases and summarises existing evidence on their effectiveness. Moreover, we describe common obstacles to effective chronic disease management. Finally, we conclude by outlining some of the actions policy makers need to take to improve the conditions for chronic disease management in Europe.

Key Words: Chronic Disease Management, Health Systems, Europe

Policy makers across Europe increasingly diabetes and asthma, but also many types and private budgets. Suhrcke and Urban2 recognise that chronic disease management of cancer and HIV/AIDS (as survival rates demonstrated that the cost of chronic (CDM), the ongoing management of and times have visibly improved), mental diseases and their risk factors, as measured conditions over a period of years or disorders (for example, depression, schiz- by cost-of-illness studies, is sizeable, decades, is one of the most important chal- ophrenia and dementia) as well as certain ranging up to 6.77% of a country’s GDP. lenges that European health systems face. disabilities (for example, visual Policy makers across Europe have Chronic conditions and diseases are the impairment). CDM is a complex response developed heterogeneous CDM strategies, leading cause of mortality and morbidity over an extended period with coordinated such as disease management programmes in Europe and research suggests that input from a wide range of health profes- (DMPs) or prevention and early detection complex conditions, such as diabetes and sionals, as well as access to drugs and interventions. However, research suggests depression, will impose an even larger equipment and patient empowerment that many of these current approaches to health burden on societies across Europe going beyond medical care into the social CDM face substantial structural problems in the future. The World Health Organi- care setting. This is in contrast with most and hence have failed to fulfil hopes and zation ‘Global Burden of Disease’ study health care today, which is structured promises.3 This article briefly outlines the estimated that, as of 2002, chronic or non- round acute, episodic models of care. principal CDM strategies and summarises communicable conditions accounted for It has been shown that the economic existing evidence on their effectiveness. We 87% of deaths in high income countries. implications of chronic diseases and condi- also highlight common obstacles impeding By comparison, 7% of deaths were tions are severe from both the macro- and successful CDM and outline a series of attributed to communicable conditions microeconomic perspectives. Chronic steps that policy makers need to take to and nutritional deficiencies, and 6% to diseases impact on wages, workforce improve the conditions for effectively injuries. Worldwide, the proportion of participation, labour productivity and managing chronic diseases in Europe.* deaths due to non-communicable or hours worked. Often, chronic conditions chronic diseases is projected to rise from contribute to early retirement, high job CDM strategies 59% in 2002 to 69% in 2030.1 turnover and disability. Overall, disease- Disease prevention and early detection CDM embraces not only the ‘classical’ related impairment of households’ interventions aim to reduce the burden of conditions such as cardiovascular disease, consumption and educational performance chronic disease through activities that affects the gross domestic product (GDP) avoid impairment to health or reduce the negatively. In addition, expenditure on likelihood of chronic conditions devel- David Scheller-Kreinsen and Miriam chronic care is rising across Europe and oping. Prevention includes primary, Blümel are Research Fellows and consumes increasing portions of public Reinhard Busse is Professor and Department Head at the Department for Health Care Management, Berlin For further in-depth information see University of Technology, Germany. http://www.mig.tu-berlin.de/sysordner_sammlung/publikationen/2009_publikationen/ Email: [email protected] veroeffentlichungen/busse_2009_managing_chronic_disease_in_europe/

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secondary, or tertiary approaches that Figure 1: Disease Management Programmes - Key Elements differ in aims and target groups. Primary prevention targets the prevention of illness • comprehensive care: multidisciplinary care for entire disease cycle by removing the causes, especially in periods of increased risk. Secondary • integrated care, care continuum, coordination of the different components prevention aims to treat disease at an early • population orientation (defined by a specific condition) stage, when first observable and perceivable pathophysiological changes • active client-patient management tools (health education, empowerment, self-care) occur, so that people can be cured early or • evidence-based guidelines, protocols, care pathways be prevented from further deterioration. Tertiary prevention activities intend to • information technology, system solutions cure, alleviate or compensate for the • continuous quality improvement impacts of a disease up the point where it can no longer be influenced.4 Source: Velasco et al, 2003.8 The specific prevention approaches adopted in a country vary according to the care and efficiency is limited so far. Pilot Most small-scale studies suggest that health care system and dominant political studies indicate that new ways to organise DMPs are hampered by a lack of coordi- opinions. European countries place provision at the structural, organisational nation between professional groups, the different emphasis on the responsibility of or individual health professional level can absence of well-targeted financial incen- the community and the individual, help to meet the challenge of effective tives, as well as fragmentation in the health depending on culturally anchored views CDM. However, these approaches often care sector. about the role of the state and the suffer from fragmentation and a lack of 5 Finally, integrated care models respond to autonomy of the individual. Overall, the coordination between different actors in the fact that chronic diseases can rarely be effectiveness of prevention and early the health system. treated in isolation. Often patients suffer detection interventions is relatively well from several chronic diseases or condi- documented for risk factors such as hyper- Disease management programmes have tions. Hence, while DMPs focus on one tension, obesity or alcohol and tobacco been implemented in many European single disease, integrated care models are consumption. In particular, research indi- countries. While no universal definition of organised to achieve better integration of cates that comprehensive approaches, DMPs exists, most definitions share three services across the whole continuum of combining several interventions are most main features: a knowledge base, a delivery care for various diseases. Integrated care effective. Compared to curative and acute system with coordinated care components, models developed in the US have been treatment, a high proportion of prevention and a continuous improvement process for influential in informing chronic care interventions have proven to be cost- a specific disease among a defined popu- 7 policies in Europe and elsewhere.3 effective. Even though prevention is a lation. Further key elements of DMPs are European countries such as England, promising strategy for managing chronic presented in Figure 1. Germany and Spain have invested consid- diseases, it still plays only a secondary role In summary, DMPs can be regarded as a erably to develop integrated care models in European health systems. Most coun- means to coordinate care, focusing on the inspired by experience in the US. Other tries have not yet reacted to the need for whole clinical course of a disease. Care is countries, such as the Netherlands or prevention of chronic diseases at a organised and delivered according to France, have established provider programmatic level. scientific evidence and patients are actively networks which bridge the gap between New professions, qualifications and settings involved in order to achieve better health ambulatory and inpatient sectors to were designed to meet the challenge of outcomes. Structured DMPs for selected achieve better integration of services across CDM in Europe. For instance, nurse prac- conditions were originally developed in the whole continuum of care. The effec- titioners, liaison nurses and community the United States and subsequently tiveness of integrated care models is nurses have been introduced in several adopted by a number of European coun- controversial. Large-scale population- countries. In addition, the tasks and tries, including Germany and the UK. The based studies are lacking. Preliminary responsibilities of existing professional effectiveness of European DMPs has not results from pilot studies suggest that some groups have shifted and expanded. For been sufficiently evaluated. Large-scale positive results may be generated, but example, the UK and Scandinavian coun- population-based evaluations with given the complexity of integrated care tries have implemented a ‘collaborative rigorous research design are lacking. In models, again implementation, coordi- methodology’ as an instrument for part, this is due to the relatively short time nation and fragmentation are key chal- managing chronic diseases by training period that has elapsed since DMPs have lenges. Moreover, studies fail to indicate physicians to have a guiding role through been established across Europe.3 Small- which components of integrated care are the health system.6 Finally, new settings scale studies suggest that DMPs may have responsible for positive and negative were established over the last decade a positive impact on the process of care for results. including nurse-led clinics, group practices congestive heart failure, coronary heart and medical polyclinics in which general disease, diabetes and depression, while the Key challenges to successful CDM practitioners, specialists and other health evidence for asthma and chronic The broad set of policy instruments to professionals cooperate. Empirical obstructive pulmonary disease is incon- meet the challenge of CDM in Europe evidence on the impact of new providers, clusive. With regard to medical outcomes, indicates that policy makers have invested qualifications and settings on the quality of the existing evidence is also inconclusive. considerable energy and resources. Never-

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Table 1: Financial incentives in European health systems

Financial incentives targeting the Financial incentives Financial incentives targeting Financial Incentives targeting individual targeting structures of care processes of care outcomes of care

Piloting ‘year of care’ payments for Per patient bonus for physicians both Points for reaching process targets Points for reaching outcome the complete package of CDM acting as gatekeepers for chronic (UK: GP contract) targets (UK: GP contract) required by individuals with chronic patients and setting care protocols (FR) conditions, For example, based on Bonus for DMP recruitment and validated ‘care pathways’ for documentation (GER) diabetes (DK; UK) 1% of overall health budget available for integrated care (GER)

Points for reaching structural targets (UK: GP contract)

Additional services (for example, patient self-management education) only reimbursable if physicians and patients participate in DMP (GER)

Note: DK = Denmark; FR = France; GER = Germany; UK = United Kingdom Source: Authors’ own table based on Busse and Mays, 2008.10

theless, research suggests that various focus on incentivised versus other tasks or While some controversy exists about the problems have yet to be tackled. This areas of quality, as well as more gaming or impact of the programme, positive section outlines some of these common better reporting, but without any improve- outcomes with regard to quality of care, issues drawing on experience from across ments in quality. especially chronic care, have been iden- the EU. tified.13 In particular, patients seem to Moreover, financial incentives influence benefit from the provision of more Financial flows and incentives various subgroups of providers or health systematic care. In addition, structures are professionals differently. Those with high, Common problems in the effective important since improvements in the average or poor performance prior to the management of chronic diseases are quality of care tend to generate intervention react differently to financial financial flows and incentives, which do (measurable) benefits only in the long- incentives. Thirdly, mixed approaches, not motivate health professionals to engage term. Hence, health professionals and combining different payment schemes in CDM. The importance of financial providers can only be effectively incen- such as fee-for-service (covering all expen- incentives is intuitive: however motivated tivised to improve chronic care, if a certain ditures after a medical intervention retro- some health care stakeholders may be to ‘continuity of care’ is ensured. spectively irrespective of the total amount implement changes to improve chronic and the quality of the service) and case fees Coordination care, few will operate counter to their (covering only a predefined fixed sum for economic interest.9 Table 1 summarises Enhancing coordination is another critical a specific intervention) may mitigate examples of the use of financial incentives dimension that must be achieved to fully negative effects of either approach applied in CDM across Europe. unveil the potential of CDM in Europe. alone. Research suggests that one of the central Different types of financial incentives are Finally, Peterson et al.12 find that the size obstacles to improved care for patients used in CDM to motivate providers and of the incentive clearly matters: a signif- with chronic diseases is the lack of coordi- health professionals: they tend to focus icant percentage of income has to be nation in health care provision. As noted either on the structure or processes of variable before providers or health profes- earlier, structured CDM approaches such care.10 Only the UK general practitioner sionals can be expected to change their as DMPs and integrated, multi-disease care (GP) contract specifically includes a range behaviours. Overly large incentives on the models suffer from fragmentation between of incentive payments focused on the other hand may motivate health profes- the different tiers of increasingly differen- delivery of particular outcomes. In general, sionals to concentrate excessively on tiated health systems. Often in chronic there has been a gradual shift of focus from incentivised goals at the expense of other care multiple actors are involved in service approaches that simply take into account implicit targets. provision over an extended period of time. the presence of patients with chronic Common reasons for coordination disease for funding towards incentives Some evidence has also been generated problems include: designed to encourage specific kinds of about the Quality and Outcomes structural and process responses at the Framework (QOF) for GPs in the UK. – Different modes of operation across provider level.11 This established pay-for-performance at sectors (primary vs. secondary; public the GP practice level by monitoring vs. private). The impacts of these incentives are rarely outcomes and quality variables. Typically scrutinised. However, the US experience – Providers incentivised to compete about 25% of practice income is offers some insights: designs that set a few rather than to cooperate. dependent on quality rewards. narrow goals may lead to an excessive

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– Individuals or professional groups and cost-effectiveness of various departure from the given structure is compensated for separate activities preventive and treatment interventions are needed for more effective coordination, or rather than for cooperation. not well established. Policy makers are whether reform can build on established therefore not optimally equipped to make norms, institutions and practice. Struc- – Rivalry over resources and power informed decisions to shape the future of turally, policy makers need to map out between professional groups. CDM. both clearly shared and clearly separated – Overlapping responsibilities and non- responsibilities of the actors involved in Pharmaceutical and medical innovation transparent accountability between the delivery of chronic care. Moreover, the divisions within providers and between It is essential that the important role of balance between local autonomy and different providers.3 pharmaceutical and medical innovation central authority during reform and continues to be recognised. A new type of routine operation needs to be defined. In addition, high levels of professional pharmaceutical, for example, personalised Operationally, there is a need to provide concern among physicians with regard to medicine, may lead to better medical sufficient funding to enable reform, while shifting competencies to other professional outcomes, adherence and improvement in at the same time compensation schemes groups, such as nurses or general practice, patients’ quality of life. At the same time, conducive to cooperation rather than can pose considerable challenges to the the development of innovative pharma- emphasising professional separation need coordination of chronic care.14 Finally, the ceuticals, especially pharmaceuticals and to be established. Finally, the workforce absence of training for staff meant to therapies targeting rather small population needs to be prepared to fulfil their new perform these new roles is a serious groups effectively at high costs, poses huge roles: hence adequate training and mutual problem. challenges with regard to authorisation and learning and communication need to be Information and communication reimbursement. initiated. technology Conclusion In the face of globalisation and the Another obstacle to the effective Given these structural and organisational European common market for goods and management of chronic diseases in Europe problems with CDM, policy makers in services, which increasingly penetrates is the lack of efficient use of information Europe can clearly contribute to health care markets, policy-makers need to and communication technology (ICT). improving the conditions for effective ensure that standards and methods of Expectations with regard to the former CDM. evidence-based evaluation are interna- were high. Abstract models and a number tionally accepted and possibly harmonised. of small-scale pilot studies suggested that With regard to financial incentives, making There is also a need to increase the trans- multiple benefits could be generated the payment schemes of different profes- parency of procedures and policy deci- through the employment of computerised sional groups compatible is a prerequisite sions. Moreover, to overcome ICT data collection and decision support to the facilitation of cooperation in multi- problems connected to functional interop- systems and data collection. In particular, disciplinary teams. Different financial erability within health systems and to the use of evidence-based medicine, incentives for members of the same address public concerns on data supported by electronic protocols and medical team may frustrate common protection, policy makers need to take the clinical pathways, was considered efforts, as economic interests may motivate lead in introducing adequate technical attractive since improvements in the demands for different approaches to standards and regulatory frameworks. quality of medical outcomes and efficiency treatment. Moreover, continuity of care Finally, policy makers need to develop a gains seemed to be achievable. needs to be one of the key preconditions for payer or provider investment in CDM clear position on the market authorisation However, experience to date does not programmes, since any net returns from and reimbursement of highly effective but suggest that ICT has generated large up-front investments tend to be made five costly personalised medicines. benefits. In many European countries, years after installation while the benefits of Furthermore, new criteria may be needed ICT initiatives suffer from unexpected avoiding severe complications tend to be to assess interventions and treatments in difficulties, budget-overruns and high collected only five to ten years after CDM, since cure is rarely the medical goal. costs. In addition, no well-grounded prevention. Hence incorporating concepts such as empirical evidence of the benefits of ICT ‘quality of life’ more explicitly into As a consequence, health systems with a has been generated. Pilot studies have marketing authorisation and reimburse- traditional focus on ‘patient choice’ of however identified a number of common ment decisions should be considered. providers, little enrolment with particular problems: functional interoperability providers and/or payment using fee-for- within health systems is not given; no service as the key approach for reim- practical tools are offered on how the vast REFERENCES bursement, all of which lead to relatively amounts of data which modern infor- 1. Mathers CD, Loncar D. Updated Projec- low continuity of care, face the greatest mation technology is able to store, can be tions of Global Mortality and Burden of difficulties in aligning financial incentives translated into meaningful information for Disease, 2002–2030: Data Sources, Methods with the goal of promoting better CDM. health professionals; and public concerns and Results. Geneva: World Health Organ- Given the former, policy makers should about data protection are not adequately ization (Evidence and Information for consider strengthening or introducing addressed. Policy Working Paper), 2005. Available at financial incentives conducive to ‘conti- http://www.who.int/healthinfo/statistics/ Evaluation nuity of care’. bodprojections2030/en/index.html Furthermore, many aspects of CDM are To enhance coordination, policy makers 2. Suhrcke M, Urban D. Is Cardiovascular not properly evaluated. The effectiveness need to decide early on whether a radical Disease Bad for Growth? Mimeo. Venice:

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Maid- five chronic diseases: heart disease, cancer, $628 billion per year; fully $211 billion of enhead: Open University Press, 2008: stroke, chronic obstructive pulmonary that increase was attributable to the 195-221. disease and diabetes.2 Many chronic increase in treated disease.3 11. Glasgow N, Zwar N, Harris M, Hasan diseases are lifelong conditions, and their Those figures represent just the direct I, Jowsey T. Australia. In: Knai C, Nolte impact lessens the quality of life, not only costs. By some measures, indirect costs E, McKee M (eds). Caring for People With of those suffering from the diseases, but actually dwarf money spent on treatment. Chronic Conditions– Experience in Eight also of their family members, caregivers A groundbreaking study in late 2007 by Countries. Copenhagen: European Obser- and others. 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But indirect costs were with the introduction of pay for Professor and Chair, Department of nearly four times as high: totalling more performance. New England Journal of Health Policy and Management, Rollins than $1 trillion.4 The same analysis esti- Medicine 2007;357:181–90. School of Public Health, Emory mates that modest reductions in unhealthy 14. Rosemann T, Joest K, Koerner T. How University, Atlanta, USA. He is the Exec- behaviours could prevent or delay forty utive Director of Emory’s Institute for can the practice nurse be more involved in million cases of chronic illness per year. the care of the chronically ill? The perspec- Advanced Policy Solutions and the tives of GPs, patients and practice nurses. Partnership to Fight Chronic Disease. Despite these significant and growing BMC Family Practice 2006;7:14. Email: [email protected] expenditures, research shows that chroni-

5 Eurohealth Vol 15 No 1 CHRONIC DISEASE MANAGEMENT cally ill patients receive only 56% of clini- require a renewed focus on preventing can also have a positive effect. Chronically cally recommended health care.5 While the disease when possible, identifying it early ill populations, particularly those suffering US is spending a staggering amount on when it occurs, and implementing from multiple diseases and conditions, or chronic disease care, objective measures evidence-based secondary and tertiary receiving services from multiple health care indicate it may not be spending wisely or prevention strategies that slow disease providers, might require appropriate and well to treat chronically ill patients. This progression and the onset of activity limi- ongoing management and intervention to discrepancy results chiefly from systemic tations, as well as save money for the ensure adherence to high-quality care and, inadequacies: the American health care patient and the health care system. ultimately, to improve health outcomes. system was built to deliver health care services to acutely ill patients requiring Evidence in support of prevention and Implementing community health episodic care, not to patients who are chronic disease management improvement programmes chronically and persistently in need of Over three-quarters of American adults Effective population health improvement medical care. Additionally, the US spends are candidates for at least one health strategies consider the range of physical, more on health care than any other indus- prevention activity which, if fully adhered environmental, and socioeconomic factors trialised nation, but by many measures, its to, would decrease heart attacks by 63% that contribute to health. Recognising both spending is not achieving the results and strokes by 31%.9 The US medical the significant problems of chronic disease wanted or needed.6 community has developed consensus and the opportunities for population health improvement, groups across the US A study comparing the trends in deaths recommendations on the clinical treatment are developing sustainable, adaptable considered amenable to health care before and appropriate preventive measures for programmes that work to improve health age 75 between 1997/98 and 2002/03 in the patients with diabetes, hypertension and and lower costs. US and 18 other industrialised countries other chronic conditions. 7 should give the US pause. On average, Aggressive secondary and tertiary Well-designed, community-based lifestyle preventable deaths account for 32% of prevention in the present system have the interventions can produce dramatic reduc- total mortality among women and 23% appearance of insurmountable time and tions in the incidence of chronic diseases 12 among men under age 75. The majority of cost requirements. Education in profes- like hypertension and diabetes. A recent the conditions responsible for preventable sional medical programmes nationwide analysis found significant reduction in deaths are chronic conditions: cancers, should frame the discussion on preventive total health care spending linked to these diabetes, ischemic heart disease, and other medicine as one of needed and lasting programmes: savings ranged from a short- circulatory disorders. The average decline benefit to patients and populations. If such term return on investment of $1 for every in amenable mortality in developed coun- actions were to be adopted nationally, the $1 invested, rising to more than $6 over the 13 tries was 16%. But the US was an outlier, aggregate results have the potential to longer term. Though limited in scope, with a decline of only 4%. If the US could decrease demand for treatment, freeing community-based programmes provide have reduced amenable mortality to the both time and resources for targeted care instructive models for design of federal average in the three top-performing coun- provision. These savings will not only be health care policy that could capture tries – France, Japan, and Australia – there enjoyed by the individual, but by the substantial health care savings through would have been 101,000 fewer deaths per entire US health care system. disease prevention and care coordination year. In addition, a recent study indicates on a national scale. that life expectancy in the US has dropped Evidence-based research suggests that well American businesses are also investing in for the first time in a hundred years, which designed prevention and primary care prevention and wellness initiatives as they may be attributed to chronic disease focused chronic disease management see costs associated with obesity and resulting from smoking and obesity.8 programmes can both improve health and provide financial value, including cost smoking-related illness increase. The rates of amenable mortality and life savings. Investments in high-impact, cost- According to the National Business Group expectancy are indicators of overall health effective population prevention and health on Health, employers are paying 100% system performance. America’s significant improvement programmes can increase the more for health care since 2000. Recog- performance gap is a worrisome signal that affordability of health care, while helping nising the negative impact on their compet- the health care system is not performing Americans live longer, healthier lives, thus itiveness and profit margin, employers are well against a set of relative health increasingly embracing workplace health contributing to higher productivity and measures. On its current trajectory, cases promotion (WHP) programmes. increased economic performance.10 of chronic disease will significantly Several scientific reviews report that WHP increase, along with their associated direct Prevention programmes must be appro- programmes reduce medical costs and and indirect costs. The truth is though, the priately tailored to specific populations; absenteeism and produce a positive return vast majority of chronic disease could be targeting people who are at higher risk is on investment. For example, at Citibank, a prevented or better managed. more effective than programmes that comprehensive health management screen large segments of the population for Discussions regarding health care reform programme showed a return on a particular illness or condition without in the US are incomplete if they do not investment of $4.70 for every $1 in regard to risk.11 When directly tied to consider the role that chronic disease plays cost.14,15 A similar comprehensive particular interventions or population in driving preventable ill-health, increasing programme at Johnson & Johnson reduced groups, prevention can be cost-effective, costs for care, and decreasing American health risks including high cholesterol even in the short term. competitiveness. Transforming the US levels, cigarette smoking and high blood health care system to better meet the needs Following the diagnosis of a chronic pressure, saving the company up to $8.8 of people with chronic conditions will disease, disease management interventions million annually.16,17

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Reforming care delivery Conclusion 8. Ezzati M et al. The reversal of fortunes: An estimated 90% of the care chronically Chronic disease management and trends in county mortality and cross- ill patients require must be self-managed, prevention, as well as health improvement county mortality disparities in the United outside the health system.18 But the US initiatives, can contribute to changing States. PLoS Medicine 2008;5(4):e66. health care system is hospital and unhealthy behaviours, improving health doi:10.1371/journal.pmed.0050066 physician-centric, which means chroni- and mitigating costs in the US. Health 9. Khan R et al. Special report: the impact cally ill patients are rarely educated to improvement initiatives reach people of prevention on reducing the burden of manage their conditions effectively outside through a variety of settings, where they cardiovascular disease. Circulation physicians’ direct care. Few have work, where they live, where they study, 2008;118:576–85. community-based support systems that and within the health care system itself. 10. Nussbaum S. Prevention: the corner- can reinforce active disease management stone of quality health care. American Care delivery clinically must include and help them stay out of the hospital. Journal of Preventive Medicine prevention, and prevention must include Reorienting the US health care system 2006;31(1):107–8. action outside the physician’s office. toward effective chronic disease care will Patients need to be educated about health 11. Russell L. Prevention’s Potential for require reform of many aspects, including conditions, empowered to maintain health Slowing the Growth of Medical Spending. payment structures to encourage coordi- and assisted in managing chronic disease. Washington, D.C: National Coalition on nation of care, patient incentives for Providers must work within a coordinated Health Care, October 2007. healthy behaviours, broader use and system of practitioners, collaborating with 12. Powell LH, Calvin JE, III, Calvin JE, adoption of health information technology the patient to deliver the care that is needed. Jr. Effective obesity treatments. American and development of the primary health Those in the US medical community must Psychologist 2007;62:234–46. care workforce. In the meantime, state and learn from past attempts, advocate for 13. Levi J, Segal L M, Juliano C. local initiatives have been able to achieve responsible change, focus on preventing Prevention for a Healthier America: remarkable changes within the existing what can be prevented and, in the end, have Investments in Disease Prevention Yield system. Exemplary among them is an enough resources to meet the most basic Significant Savings, Strong Communities. effort by the state of Vermont. health care needs of Americans nationwide. Washington D.C: Trust for America’s Vermont has been first in launching a state- Health, 2008. Available at wide collaborative system of care for http://healthyamericans.org/reports/ chronically ill patients. The Vermont Blue- REFERENCES prevention08/Prevention08.pdf. print for Health creates ‘medical homes’ 1. Centers for Disease Control and 14. Ozminkowski RJ et al. The impact of for patients with chronic diseases, bringing Prevention. Chronic Disease Overview. the Citibank, N.A, health management together: Atlanta: CDC, 2009. Available at program on changes in employee health http://www.cdc.gov/nccdphp/overview.htm risks over time. Journal of Occupational – patients, who learn how to manage their and Environmental Medicine health conditions; 2. Hoffman D. An Urgent Reality: The 2000;42(5):502–11. Need to Prevent and Control Chronic – primary care physicians, who oversee Disease. Atlanta: National Association of 15. Ozminkowski RJ et al. A Return on patients’ care; Chronic Disease Directors, 2008. Available investment evaluation of the Citibank, N.A., health management program. – health care teams, to provide individu- at http://www.chronicdisease.org/files/ public/Chronic_Disease_Prevention_ American Journal of Health Promotion alised support to the patient, including 1999;44(1):31–43. one or two health providers (typically White_Paper.pdf. nurses), a public health specialist, and 3. Partnership to Fight Chronic Disease. 16. Goetzel RZ et al. The long-term impact of Johnson & Johnson’s health & wellness community health workers; and Almanac of Chronic Disease 2008 Edition. Available at http://www.fightchronicdisease. program on employee health risks. Journal – patients’ local communities. org/pdfs/PFCD_FINAL_PRINT.pdf. of Occupational and Environmental Medicine 2002;44(5):417–24. To support the medical home model, the 4. DeVol R, Bedroussian A. An Unhealthy legislature changed how providers are paid America: The Economic Burden of Chronic 17. Ozminkowski RJ et al. Long-term for care. Participating providers receive Disease. Santa Monica, California: The impact of Johnson & Johnson’s health & normal fee-for-service reimbursements Milken Institute, 2007. Available at wellness program on health care utilization and expenditures. Journal of Occupational plus a care management fee. This fee is tied http://www.milkeninstitute.org/pdf/ and Environmental Medicine to the competencies measured in the chronic_disease_report.pdf 2002;44(1):21–29. National Committee for Quality 5. McGlynn E et al. The quality of health Assurance’s (NCQA) patient-centred care delivered to adults in the United 18. California HealthCare Foundation. medical home model. Under the NCQA States. New England Journal of Medicine Chronic Disease Care Reports and Initia- criteria, specific points are assigned for 2003;348:2634–45. tives: Patient Self-Management. Oakland: different capabilities, such as the adoption California HealthCare Foundation, 2008. 6. OECD. Health at a Glance 2007: Available at http://www.chcf.org/topics/ of evidence-based guidelines for care, OECD Indicators. Paris: OECD, 2008. chronicdisease/index.cfm?subtopic=CL613 active patient self-management support Available at http://www.oecd.org/ and systematic tracking of test results and document/14/0,3343,en_2649_34631_1650 19. Wolke A. Vermont Pilots Medical identification of abnormal results. As a 2667_1_1_1_1,00.html. Homes for the Chronically Ill. Washington practice’s skills and competencies increase, D.C: National Conference of State 7. Nolte E, McKee CM. Measuring the payments increase along a sliding scale.19 Legislatures, July 2008. Available at health of nations: updating an earlier http://www.ncsl.org/programs/health/shn/ analysis. Health Affairs 2008;27(1):58–71. 2008/sn519c.htm.

7 Eurohealth Vol 15 No 1 CHRONIC DISEASE MANAGEMENT Adopting integrated mainstream telecare services Lessons from the UK

James Barlow and Jane Hendy

Summary: ‘Telecare’, the use of Information and Communication Technology (ICT) to support health and social care remotely, has been around for many years. Its potential has been recognised in health policy in many countries and there have been numerous pilot projects and technology trials. However, implementation is generally characterised by a failure of pilot projects to develop into sustainable services. This paper argues that this is due to the quality of the evidence base for its benefits, problems in integration with existing care services and responsibilities for payment and reimbursement.

Keywords: Telecare, Telemedicine, Innovation, Implementation, UK

‘Telecare’, the use of Information and recognised in health policy in the UK,1 in terms of individual patient outcomes Communication Technology (ICT) to US2 and Europe.3 Around the world there (i.e., clinical or quality of life improve- support health and social care remotely, have been numerous pilot projects and ment). However, the evidence for benefits often in a patient’s own home, has been technology trials. in terms of economic impact or impact on around for many years. Its development care delivery processes is limited, although The UK government’s position certainly has been driven partly by technological there is some simulation modelling based supports this. Since 1998, over twenty advances in sensing equipment and data on limited data.5 government reports have called for processing, as well as a policy concern with telecare. These have now resulted in Building an evidence base for the indi- the costs of an ageing population and a rise around £175m of finance over the period vidual and system-wide impacts of telecare in the number of people with chronic 2006–2011 via a number of initiatives to is now felt to be critical for convincing long-term conditions. There are also support uptake.* This support is needed. those making telecare investment decisions growing public expectations: increasingly While an increasing number of people have and those who have to use it. With this in we expect to receive a more personalised received telecare as part of a pilot project, mind the English Department of Health is package of care at a convenient time and it still cannot be described as a mainstream funding the largest randomised control place of our choosing. These factors have part of care delivery: implementation is trial (RCT) of telecare so far undertaken, made the introduction of mainstream characterised by a failure of pilot projects based on its Whole System Demonstrators telecare attractive to governments and care to develop into sustainable services. programme. This was launched on 1 June providers. Its potential is increasingly 2008 and is designed to test the benefit of Using evidence to stimulate uptake whole-system redesign of services for James Barlow is a Professor of Technology Part of the problem is the quality of the those with long-term health conditions and Innovation Management at Imperial evidence base for the benefits of telecare. and social care needs. Three contrasting College Business School, London, UK, Almost 9,000 studies reporting on telecare sites in England have been chosen, with a and Co-Director of the Health and Care trials and pilot projects have been variety of demographic and geographical Infrastructure Research and Innovation published in scientific journals, yet within contexts. Each site is putting in place inte- Centre (HaCIRIC). Jane Hendy is a this wealth of information very little grated packages of personalised health and Research Fellow at Imperial College strong conclusive evidence has emerged.4 social care, including systematic chronic Business School and a member of For some specific applications, for example disease management programmes. It is HaCIRIC. telecare aimed at patients with diabetes or anticipated that the demonstrator sites will Email: [email protected] heart disease, there is evidence of benefits involve approximately 7,500 telecare users. Acknowledgments This paper is based on research supported * Comprising £80 million for the Preventative Technologies Grant and £31m for the Whole by the Department of Health and the System Demonstrators programme in England, £9m for the Telecare Capital Grant Engineering and Physical Sciences programme in Wales, £8m for the Telecare Development Fund in Scotland, and Northern Research Council funded HaCIRIC. Ireland’s £46m telecare investment programme.

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The government views the Whole System redesign of care service models to accom- involved. Identifying all these stake- Demonstrators as a way of meeting the modate telecare, and to payment and reim- holders, engaging everyone, aligning their challenge of providing credible evidence bursement for services. respective agendas towards telecare and that integrated care, combined with the use maintaining momentum takes time and of telecare, benefits individuals and Integration with existing services effort. Similarly, training operational staff delivers improvements. It will also test Telecare requires different levels of inte- and raising awareness amongst other staff whether telecare is a cost-effective means gration between health and social care is time consuming. of future care delivery. depending on the type of services being A key challenge for achieving integration is offered. The introduction of mainstream The availability of evidence certainly plays data sharing and the use of statutory stan- telecare must recognise this complexity, a part in influencing the uptake of health dards. The availability of a shared health with the development of responsive, care innovations. However, in many areas and social care record keeping service and flexible service structures that can work of health and social care, the credibility of an electronic single assessment process equally well across different agencies. evidence is subject to interpretation and would make telecare much easier to Achieving this will not be easy. A review negotiation.6 A number of commentators implement and operate. This was promised of public sector management by Ferlie and have argued that RCTs are an inappro- in the introduction of the UK National colleagues illustrates the difficulties of priate model for gathering evidence for the Programme for IT,9 yet shared patient achieving fundamental change and benefits of complex service delivery inter- records remain elusive five years after cautions against over-optimistic hopes of ventions such as telecare.7 Evidence inception of the programme. With data reform associated with new ways of gathered through an RCT approach may sharing amongst NHS staff proving this working in the public sector.8 The joint help to convince sceptical physicians, but difficult, it is hard to envisage that the activities resulting from increased imple- such evidence alone is unlikely to be added involvement of social and com- mentation of telecare are more likely to equally valued and applied across all the munity care services will be any easier, and produce a series of incremental changes relevant stakeholders involved in the main- currently very little progress is being made. stream implementation of telecare. than complete system change. Arguably, the main beneficiaries of telecare The most important parts of a new telecare Payment and reimbursement are patients and family carers, through the service are the models for assessment, Another challenge in the UK, and in many provision of independence, security, confi- installation, monitoring and response. other countries, is the way health and social dence, quality of life, and the ability to stay Identification of appropriate clients and care services are currently funded. Telecare in one’s own home. These benefits are hard assessment of their needs in relation to demands true partnership working because to quantify, but RCT measures such as available telecare technology and services costs and benefits lie with different stake- admissions avoidance are unlikely to has proved hard due to a lack of awareness holders. ‘Silo thinking’ about budgets and convince telecare users and their families. by different groups of health and social future investment slows down the process The context into which telecare is imple- care professionals and the slowness in of implementation. In the UK most health mented will also be different from area to introducing a national ‘single assessment care services are free to the users, whilst area. Future telecare services may involve process’. Installation is particularly many social care services are means tested. unique sets of interventions and users that important as it moves telecare from being This is particularly problematic for the will not be comparable. The evidence a purely technical service to becoming part introduction of telecare, where the bound- gathered has to fit with these demands. So of the care service with installers helping aries between the ‘health’ and ‘social’ part of the challenge is not to just produce users to understand the system. However, aspects of monitoring may be blurred. developing suitable supply chain arrange- more evidence, but to produce evidence This complexity is combined with the ments, involving equipment manufacturers that convinces different stakeholders across uncertain impact of implementing telecare and local authority social or housing professional boundaries and different on costs and benefits. For example, the services, has not always proved easy. familial and organisational contexts. current policy initiative in England made Finally, while there is already an infra- local authority social services departments The professional autonomy of care profes- structure for monitoring and response in primarily responsible for telecare invest- sionals, especially within the NHS, has the form of several hundred local proved problematic, especially in relation ment costs, having directly received part of community alarm centres, these are not to general practitioners’ hegemony and the Preventative Technologies Grant. necessarily equipped or have the expertise difficulties in engaging this group. Physi- However, exactly how the different organ- to take on health, as opposed to social, cians need to be persuaded that telecare is isational elements of the health and social monitoring of clients. useful to both their practice and the health care system benefit from this expenditure, of their patients. In the UK this issue is To move away from the small pilot and in what ways, is currently very unclear. partly being addressed by the growing role projects of the past to mainstream inte- This, is turn, makes it hard for commercial of specialist community nursing, which is grated services, health and social care suppliers of telecare equipment to develop being used to underpin some telecare organisations will need to think carefully suitable business or charging models.10 services for patients with long term about the way they plan, commission, chronic conditions and help demonstrate procure, deliver and install telecare. The Conclusions that this approach can help physicians technologies and processes on which Despite limited evidence on its benefits, in manage their case loads more effectively. telecare are based need to be a catalyst for the UK a combination of central But even without the problem of an new levels of collaborative working government policy and funding, a belief in adequate evidence base, there are still because of the many stakeholders from its potential by certain ‘champions’ in local enormous challenges which relate to the health and social care that need to be social services and health authorities is

9 Eurohealth Vol 15 No 1 CHRONIC DISEASE MANAGEMENT slowly pushing telecare forward. System Dynamics Review 2007;23:61–80. REFERENCES Sustaining the current momentum, 6. Fitzgerald L, Ferlie E, Wood M, however, will require constant attention 1. Department of Health. Our Care, Our Hawkins C. Interlocking interactions. The and reinforcement of existing initiatives – Say: A New Direction for Community diffusion of innovations in health care. it is essential that the current wave of trials Services. London: Department of Health, Human Relations 2002;55:1429–49. and pilot projects do not slip back once 2006. Available at 7. Williams T, May C, Mair F, Mort M, government funding ends. www.dh.gov.uk/en/Healthcare/Ourhealth ourcareoursay/index.htm Gask L. Normative models of health tech- Scaling-up from existing schemes will nology assessment and the social 2. Stachura M, Khasanshina E. Tele- require care providers to understand how production of evidence about telehealth homecare and Remote Monitoring: An telecare can be integrated into existing and care. Health Policy 2003;64:39–54. Outcomes Overview. Augusta, Georgia: new care pathways. This means that the Center for Telehealth, Medical College of 8. Ferlie E, Hartley J, Martin S. Changing cultural differences between different care Georgia, 2007. Public Service Organisations: Current organisations need to be addressed, and the perspectives and future prospects. British right incentives for innovation are put in 3. Whitehouse D, Virtuoso S. TeleHealth Journal of Management 2003;14:S1–S14. 2007: Telemedicine and Innovative Tech- place. nologies for Chronic Disease Management. 9. Burns F. Information for Health. An While there are examples of telecare Colloquium Report. Brussels: European Information Strategy for the Modern NHS schemes in some other countries, the major Commission (Information, Society and 1998–2005. Wetherby: Department of Health Publications, 1998. Available at initiatives in the four countries of the UK, Media programme), 2008. http://www.dh.gov.uk/en/Publicationsand- including the Preventative Technologies 4. Barlow J, Singh D, Bayer S, Curry R. A statistics/Publications/Publications Grant and the Whole System Demon- systematic review of the benefits of home PolicyAndGuidance/DH_4007832 strators, represent the most important telecare for frail elderly people and those concerted effort by government to stim- with long-term conditions. Journal of 10. Bowers S. Accenture to quit NHS tech- ulate innovation in this field. The next few Telemedicine and Telecare 2007;13:172–79. nology overhaul. The Guardian 28 years should provide many useful oppor- September 2006. Available at 5. Bayer S, Barlow J, Curry R. Assessing http://www.guardian.co.uk/technology/ tunities for learning about the potential the impact of a care innovation: telecare. 2006/sep/28/news.business and pitfalls of telecare.

Economic considerations of remote monitoring in chronic conditions

Paul Trueman

Summary: Remote monitoring systems allow for the capture of routine information on the health status of individuals with chronic conditions. The potential benefits of remote monitoring include reduced demand on scarce health care resources and more intensive monitoring of an individual’s health, which may ultimately result in improved long-term outcomes. Evidence on the economic benefits of remote monitoring remains equivocal. Further research of the cost effectiveness of remote monitoring in practice is warranted.

Key words: Remote Monitoring, Telemedicine, Economics, Chronic Conditions

The increasing prevalence of chronic health service resources. Routine consulta- nology to help manage these patients. conditions, such as diabetes and heart tions to check the health status of patients Technological solutions have developed disease, places an enormous burden on with such conditions consume significant rapidly and there has been a significant resources in both primary and acute care. growth in the application of information The demand on the health service for technologies to health care over the last Paul Trueman is Director of the York routine consultations to monitor chronic two decades.1 Health Economics Consortium, conditions is one of the reasons that there University of York, UK. Terms such as telemedicine, telehealth and is increased interest in harnessing tech- Email: [email protected] telecare have been used, often synony-

Eurohealth Vol 15 No 1 10 CHRONIC DISEASE MANAGEMENT mously, to describe the application of of blood glucose levels or blood pressure economic evidence to support the routine modern information and communication and ultimately reductions in serious adoption of telemedicine. technologies to health and social care.2 adverse outcomes, such as hypoglycaemic A further review paper published by Paré These broad definitions capture a range of events or heart attacks. The potential and colleagues in 2007 examined the technologies, from patient operated alarm benefits have both clinical and economic evidence specifically related to home tele- systems often used in residential care,3 to implications for patients and the health monitoring for four chronic conditions, technologies designed to allow for a virtual service. The challenge is to generate namely diabetes, cardiovascular disease, consultation with a health care profes- evidence to show that these theoretical pulmonary disease and hypertension.11 sional, particularly in remote geographical benefits can be realised in practice. The review included a total of sixty-five areas,4 to technologies designed to allow empirical studies across the four disease health care professionals to monitor the The economic evidence on remote areas. The authors reported that the health status and vital signs of individuals monitoring research indicated that home telemoni- in real time.5 There is a growing body of evidence on the toring was largely safe, efficacious and clinical and cost effectiveness of telemed- Remote monitoring (sometimes referred to acceptable to patients. However, as per the icine interventions, including remote as telemonitoring) of chronic conditions is earlier reviews, the authors noted the monitoring technologies, in the one of the most widely used applications absence of an unequivocal economic case. management of chronic conditions.8 of technology in health care. Remote Of the studies included, 26% included However, empirical analysis of the monitoring involves capturing information some form of cost analysis. The authors evidence on the cost effectiveness of on vital signs or clinical indicators to were unable to make any recommenda- telemedicine interventions has raised monitor a patient’s condition. Remote tions based on the findings of these studies, concerns about the quality of evidence monitoring can take many forms. In some mainly due to limitations in the method- available to support these technologies. cases, patients may be required to ologies used and heterogeneity across the manually input data into a device and then Roine and colleagues conducted a studies. The authors did though make a transfer the data, through a telephone or systematic review of the evidence on strong case for future studies of home computer interface (often referred to as telemedicine interventions in 2001.9 The monitoring to focus on examining issues ‘store and forward’ systems). Data can review included several studies of remote associated with patient outcomes, quality then be stored on a secure server and monitoring interventions, the majority of of life and the economic implications for accessed by a health care professional able which were intended to contribute to the health services. This evidence is seen as to interpret the findings. More advanced management of diabetes and heart disease being important to securing more wide- technologies include automated data by monitoring vital signs. Whilst the spread adoption and coverage by payer capture, often in real-time, and communi- majority of these studies produced bodies. cation through the use of advanced infor- improvements in clinical indicators (for mation systems comprising wireless example, HbA1c levels, blood pressure), Discussion communication. evidence to support an economic benefit of These reviews highlight the equivocal remote monitoring was limited. Where nature of the economic evidence on remote Such technologies have been widely used economic analyses were included in monitoring in chronic conditions. in investigative studies in common chronic studies these tended to focus only on costs. However, these findings need to be inter- conditions, including diabetes6 and heart Only one study was identified which preted in context. Home monitoring disease.7 The rationale for adoption in reported cost effectiveness ratios for an remains a relatively novel health care inter- chronic conditions appears to be based on intervention designed to assist in managing vention, having only been introduced into several hypotheses: blood pressure. mainstream practice over the last two – Firstly, remote monitoring can reduce decades. As such, the evidence base Whitten and colleagues conducted a the need for routine consultations with remains in development and largely systematic review of cost effectiveness a health care professional by providing derived from small-scale pilot studies. The studies of telemedicine interventions, regular information on an individual’s reviews considered above suggest that the published in 2002.10 The review identified health status; volume of economic evidence on these fifty-five studies of telemedicine that technologies is increasing over time, – Secondly, by providing more regular or captured cost data. Over 50% concluded although there is still some concern over continuous information on vital signs, that telemedicine saves money/time and the quality of studies, particularly with remote monitoring can allow for more money whilst only 7% concluded that regard to their short-term nature and the intensive management of an individual’s telemedicine does not save money. widespread use of partial economic condition which has the potential to However, these positive findings need to analysis. reduce acute exacerbations and improve be considered with some caution and the long-term outcomes; authors noted that the economic evidence It should be acknowledged that the evalu- tended to be derived from small-scale, ation of such technologies is challenging – Thirdly, patients are expected to find short-term studies that were often charac- for a number of reasons. First, remote remote monitoring more convenient terised by poor design and inadequate monitoring is a disruptive technology that and accessible than direct consultations technical quality. The majority of studies requires changes to treatment pathways with a health care professional. included only partial analysis of costs and and the attitudes of health care profes- In chronic conditions such as diabetes and no examples of full cost utility analysis sionals, all of which take time. For heart disease, these benefits might manifest were identified. The authors concluded example, despite the more intensive nature themselves in the form of tighter control that there was only limited persuasive of remote monitoring, health care profes-

11 Eurohealth Vol 15 No 1 CHRONIC DISEASE MANAGEMENT sionals may continue to adhere to their payment remain barriers to adoption in Three generations of telecare in the elderly. usual referral patterns for some time many countries. Whilst remote monitoring Journal of Telemedicine and Telecare following its introduction. Care needs to systems may offer potential efficiencies in 1996;2(2):71–80. be taken in designing studies of remote the use of health care resources, it has long 4. Scuffham PA, Steed M. An economic monitoring technology to ensure that the been acknowledged that reimbursement evaluation of the Highlands and Islands benefits are fully realised in trial settings. systems need to change to incorporate teledentistry project. Journal of Telemed innovation.14 Indeed, many reim- and Telecare 2002;8(3):165–77. Second, the evaluation of remote moni- bursement systems, particularly those toring technologies is highly context 5. Farmer AJ, Gibson OJ, Dudley C, et al. based on fee-for-service, actually disincen- specific. That is, the effectiveness of the A randomised controlled trial of the effect tivise to the use of telemedicine by technology is also heavily dependent on of real time telemedicine support on providing coverage for direct consultations local treatment pathways, health care glycaemic control in your adults with Type but not for remote monitoring. The result professional’s attitudes and patient popu- I diabetes. Diabetes Care 2005; 28(11): is an incentive to rely on unnecessary 2697–702. lations. As a result, much of the research consultations, many of which could be published to date has been characterised by 6. Jaana M, Pare G. Home telemonitoring managed more efficiently using tech- poor external validity, meaning that more of patients with diabetes: a systematic nologies that permit remote monitoring. widespread adoption may be restricted due assessment of observed effects. Journal of to the limited generalisability of study There are signs of expanding reim- Evaluation in Clinical Practice settings. bursement and coverage for remote 2007;13(2):242–53. consultations and monitoring, particularly 7. Clark RA, Inglis SC, McAlistar FA, These factors suggest that more pragmatic, in the United States.15 However, many Cleland JG, Stewart S. Telemonitoring or observational, in-use research on remote routine monitoring technologies find structured telephone support programmes monitoring technologies is required. Such themselves in something of a vicious circle. for patients with chronic heart failure: a studies should take care to ensure that they Payer bodies are reluctant to provide wide- systematic review and meta-analysis. are designed to allow for an assessment of spread access, as the evidence that is British Medical Journal 2007; 334:942–45. the effectiveness of remote monitoring available for the technologies is derived 8. Wootton R. An editor’s view of telemed- relative to current practice, and also from small scale studies which are criti- icine. Journal of Telemedicine and Telecare capture the impacts of novel technologies cised on the grounds of their limited appli- 2004; 10(6):311–17. on organisational and financial outcomes. cability to a larger population. However, Ideally, studies should incorporate full 9. Roine R, Ohinmaa A, Hailey D. generating evidence in a larger population economic evaluations as opposed to the Assessing telemedicine: a systematic review demands that such technologies are more partial analyses that characterise the of the literature. Canadian Medical Associ- widely available which requires some form majority of evidence published to date. ation Journal 2001;18:765–71. of coverage and reimbursement to be in Frameworks for the evaluation of telemed- 10. Whitten PS, Mair FS, Haycox A, May place. icine have been made available.12 CR, Williams TL, Hellmich S. Systematic Appropriate financial incentives for review of cost effectiveness studies of The absence of robust economic evidence remote monitoring need to be put in place. telemedicine interventions. British Medical on remote monitoring systems, and These should ensure that the efficient use Journal 2002; 324:1434–37. telemedicine interventions more generally, of remote monitoring, instead of direct 11. Pare G, Jaana M, Sicotte C. Systematic is a concern. However, it is worthwhile consultations, is incentivised where this is review of home telemonitoring for chronic considering the primary intention of many clinically justified. Systems also need to be diseases. Journal of the American Infor- remote monitoring systems. Such systems put in place to ensure that patient care is matics Association 2007;14(3):269–77. are often developed with non-financial not compromised through any reduction objectives, including improving access to 12. Sisk JE, Sanders JH. A proposed in direct contacts with health care profes- care, patient satisfaction and health framework for economic evaluation of sionals. Finally, it is vital that information telemedicine. Telemedicine Journal outcomes. Whilst these systems have the is captured prospectively on the use of 1998;4(1):31–37. potential to lead to more efficient use of these systems to determine whether they health service resources, they will not 13. New Zealand Medical Association. offer improvements in patient outcomes, necessarily lead to reductions in health care Telemedicine – Position Statement. access to care and health service efficiency. expenditure. Indeed, it has been suggested Wellington: NZMA, 2008. Available at Only by generating further evidence can that whilst technology offers the potential http://www.nzma.org.nz/news/policies/tel payer bodies make a rational decision to reduce the demand for less complex emedicine.pdf about the appropriate use of remote moni- consultations it should be considered as an 14. Wootton R. Telemedicine: a cautious toring technologies. adjunct to direct consultations with a welcome. British Medical Journal health care professional, rather than as a 1996;313:1375–77. substitute.13 If this is the case then tech- REFERENCES 15. Brown NA. State Medicaid and private nologies such as remote monitoring may payer reimbursement for telemedicine: An require increased investment in return for 1. Debnath D. Activity Analysis of overview. Journal of Telemedicine and improvements in patient outcomes and telemedicine in the UK. Postgraduate Telecare 2006;12(Supp 2):S32–39. access. Medical Journal 2004;80:335–38. 2. Norris AC. Essentials of Telemedicine The absence of an unequivocal argument and Telecare. Chichester: Wiley, 2001. to support the cost effectiveness of remote technologies means that coverage and 3. Doughty K, Cameron K, Garner P.

Eurohealth Vol 15 No 1 12 CHRONIC DISEASE MANAGEMENT European Commission perspective: Telemedicine for the benefit of patients, health care systems and society

Michael Palmer, Christoph Steffen, Ilias Iakovidis and Flora Giorgio

Summary: In November 2008, the European Commission adopted a Communication to support the deployment of telemedicine for the benefit of patients, health care systems and society. Telemedicine can support better quality, safer and more efficient health systems that empower patients throughout the EU. Actions proposed aim to improve confidence and acceptance of telemedicine services amongst users (professionals and patients), clarify legal aspects, solve technical issues and support market deployment.

Keywords: Telemedicine, Chronic Disease Management, Telemonitoring, Teleradiology, European Policy

For twenty years the European Commission Communication on Box 1: Illustration of benefits to patients and Commission has funded research on Telemedicine for the Benefit of Patients, professionals from greater use of eHealth systems and tools, including Healthcare Systems and Society was telemedicine telemedicine. Since the adoption of the published in November 2008.2 eHealth Action Plan in 2004,1 the Patients with chronic heart conditions being Commission’s role has broadened to Supporting patients and health profes- monitored at home for early symptoms of aggravation and timely treatment adaptation. include policy support to the deployment sionals alike of eHealth, supporting better quality, safer Telemedicine comprises ICT (Information Diabetes patients in remote areas of the EU and more efficient health systems that and Communication Technology) having regular eye checks carried out by empower patients throughout the EU. -enabled health care services that are experienced ophthalmologists in major provided to patients in situations where Telemedicine is the latest focus of this diabetes centres without the need to travel. one or more health care professionals and support to deployment. While research in the patient are not in the same location. It telemedicine-related areas (for example, Hospital radiology departments being better involves secure transmission of medical Personal Health Systems) continues able to cope with peaks in activity and data and information, through text, sound, through the Research and Development reducing delays by sending radiographs out images or other forms needed for the for remote interpretation. Framework programmes, support to prevention, diagnosis, treatment and deployment is co-funded by the follow-up of patients. Supporting telemed- Commission through the Competitiveness through Information and Communication icine deployment, as advocated in the new and Innovation programme as well as Technologies can optimise the use of scarce Communication, could lead to concrete through cohesion and structural funds. human and financial resources in the benefits for patients and health profes- medical field.” EU Health Commissioner Following extensive consultation in 2007 sionals (Box 1). Androula Vassiliou, also at the launch, and 2008 with Member States, health At the launch of the initiative, Viviane added that “the key to success is the full professionals, patients associations and Reding, EU Commissioner for Infor- involvement of citizens, patients and industry representatives, where it received mation Society and Media commented that health professionals”.3 strong support from all parties, a “telemedicine can radically improve chronically ill patients' quality of life and An ageing Europe with chronic illnesses The authors are based at the ICT for give people access to top medical expertise. needs new solutions Health Unit, DG Information Society It is our duty to make sure patients and In an ageing Europe, where more and and Media, European Commission, health professionals can benefit from it.” more citizens live with chronic diseases, Brussels, Belgium. At the same time she noted that “the telemedicine is an important tool. For Email: [email protected] provision of remote health care services instance, it allows the monitoring of

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identified. Here we focus on three key Box 2: Actions to support Members States achieving large-scale and beneficial deployment of issues: telemedicine services 1. Increasing confidence and acceptance of telemedicine services The Commission will support the development by 2011 of guidelines for consistent assessment of telemedicine services’ impact, including effec- Awareness of the benefits of telemedicine tiveness and cost-effectiveness. This will be based on the work of experts in by users (patients, health professionals and the field, Commission supported studies, large scale pilot schemes and payers) and acceptance of the technology relevant research projects. by health professionals are crucial elements In 2010, the Commission, via its Competitiveness and Innovation for the success of telemedicine. Only the Programme, will support a large-scale telemonitoring pilot project. This buy-in of users will allow a seamless inte- will include a network of procurers and payers of health care services. gration of these technologies into the normal health care delivery processes and Building confidence The Commission will continue to contribute to European collaboration in and acceptance of between health professionals and patients in key areas with potential for allow the progressive changes in medical telemedicine services greater application of telemedicine in order to make concrete recommen- practices to take place. dations on how to improve confidence and acceptance of telemedicine, 2. Gaining legal clarity also taking into account ethical and privacy related aspects The right of establishment for health Member States are urged to assess their needs and priorities in telemed- professionals exercising telemedicine, icine by the end of 2009. These priorities should form part of the national accreditation and authorisation schemes to health strategies to be presented and discussed at the 2010 eHealth provide telemedicine services, as well as ministerial conference. issues on liability, the recognition of The Commission will support the collection of good practice on deployment professional qualifications or protection of of telemedicine services in the different Member States. personal data related to health, are among the areas which require legal clarity, both In 2009, the Commission will establish a European platform to support at EU and national level. Member States in sharing information on current national legislative frame- 3. Overcoming technical issues and works relevant to telemedicine and proposals for new national regulations. supporting market development In 2009, the Commission, in cooperation with Member States, will publish Tackling legal and an analysis of the European legal framework applicable to telemedicine Issues linked to infrastructure, such as regulatory obstacles services. access to broadband and the ability of the provider to enable full connectivity By the end of 2011, Member States should have assessed and adapted ranging from urban, densely populated national regulations enabling wider access to telemedicine services. Issues communities to remote, rural, sparsely like accreditation, liability, reimbursement and data protection should be populated areas still represent a major addressed. challenge. Evidence on large scale benefits needs to be presented to political leaders By the end of 2010, industry and international standardisation bodies, with and payers to enable further investment in the support of the Commission, shall issue a proposal on interoperability of telemedicine processes that not only Solving technical telemonitoring systems, including existing and new standards. improve access to quality care but also issues and facilitating By the end of 2011, the Commission, in cooperation with Member States, promise to achieve more for less in a sector market development will issue a policy strategy paper on pan-European conformance testing of traditionally constrained by resources and interoperability, functionality and security of telemonitoring systems based unequal geographical coverage of skills. on existing, newly adopted or emerging standards at European level. Proposed actions to accelerate important health parameters, such as blood It can also contribute substantially to the deployment and use sugar levels or blood pressure within the growth of the European economy. Small The Commission proposes three sets of patient’s home, avoiding troublesome and, and medium-sized enterprises (companies strategic actions to be carried out either particularly in the case of older people and with no more than fifty employees), in jointly or at Community or Member State those with severe health problems, poten- particular, can tap into the financial and level alone which appear to be most urgent tially exhausting trips to a doctor or clinical benefits from this expanding and could provide maximum added value hospital. It can improve the availability of market, provided that some of the barriers (see Box 2). The first group focus on specialised care in remote areas where to development can be addressed. increasing confidence and acceptance of access to health care is difficult. telemedicine services among users, mainly Furthermore, it can contribute to a Key challenges to deployment through the provision and dissemination reduction in waiting times, for example in Despite the potential benefits that telemed- of scientific evidence of effectiveness and radiology, when reading and interpreting icine can provide, its use is still limited in cost-effectiveness, particularly if imple- medical images, such as radiographs (X- most parts of the EU. During the extensive mented on a large scale. rays) or if Computed Tomography (CT) consultation exercise that took place in In the case of the telemonitoring pilot scans are performed at a distance. preparation for the Communication, many project, the aim is to validate, in real-life barriers that need to be overcome to facil- Telemedicine not only can benefit patients. settings on a large scale, the use of existing itate greater deployment and use were Personal Health Systems for innovative

Eurohealth Vol 15 No 1 14 CHRONIC DISEASE MANAGEMENT types of telemedicine services and to prepare for their wider deployment. It will A clinical perspective on focus on Cardiovascular Disease (CVD); Chronic Obstructive Pulmonary Disease (COPD) and diabetes. Its final objective is remote monitoring of to ensure that providers of telemedicine services across Europe monitor and evaluate the provision of such services chronic disease according to similar methodologies on a large scale. A second group of actions focus on tackling legal and regulatory obstacles that prevent a wider use of telemedicine. They Jillian P Riley and Martin R Cowie recognise that only a few Member States have clear legal frameworks for enabling telemedicine. The final two actions aim at solving technical issues, including intraop- Summary: Chronic disease management programmes have developed rapidly in erability and standardisation, in order to an attempt to provide high quality evidence-based care to an increasing number allow better market development. Beyond of people living with chronic medical conditions. Such programmes are frequently these actions, the Commission will soon based on regular home or clinic visits that limit their ability to match demand. release a document outlining additional Innovative methods to extend the reach of such programmes are urgently issues raised during the consultation required. This article discusses the use of remote monitoring as part of chronic exercise that need to be addressed in order disease management and draws upon the authors’ experience in a heart failure to enable further deployment of telemed- population. icine. Key words: Technology, Remote Monitoring, Chronic Disease Management, Delivery of Care REFERENCES 1. Commission of the European Communities. Communication from the The number of people living with chronic because of the change in working practice Commission to the European Parliament, disease, particularly cardiovascular disease, for health care practitioners, but the the Council, the European Economic and is increasing rapidly across the world, evidence is accumulating that such an Social Committee and the Committee of the Regions on ‘e-Health – Making largely due to the unprecedented ageing of approach can be an effective component of Healthcare Better for European Citizens: the world’s population. This provides a high-quality care. There is a large degree an Action Plan for a European e-Health major challenge to health care systems, of heterogeneity in the structure of tele- Area’. Brussels: Commission of the particularly where access to optimal monitoring programmes, and it remains European Communities, 2004, COM 356. evidence-based care is poor. There is a unclear as how best to employ both tech- Available at http://ec.europa.eu/ need for innovative strategies to provide nology and staff, and how to integrate new information_society/doc/qualif/health/ support for high quality chronic disease programmes into existing health care COM_2004_0356_F_EN_ACTE.pdf management. Telehealth has been practice. The most robust evidence applies 2. Commission of the European proposed as one such strategy. to diabetes, chronic lung disease and heart failure. In many health care communities, Communities. Communication from the In theory, such technology should enable telemonitoring has been introduced Commission to the European Parliament, the limited number of health care profes- without much consideration of how it the Council, the European Economic and sionals to interact with a larger number of should best be employed or how it fits into Social Committee and the Committee of individuals with chronic health problems. the Regions on ‘Telemedicine for the the usual information flow about patients. This facilitates the early identification of Benefit of Patients, Healthcare Systems and An early review of the technology problems requiring health care inter- Society’. Brussels: Commission of the concluded that although feasible, such vention (such as hospital admissions, European Communities, 2008, COM 689. technology had yet to prove its clinical doctor office reviews, or change in Available at http://ec.europa.eu/ benefit.1 Professional disease guidelines medication), whilst empowering indi- information_society/activities/health/ remain largely silent on how best to use viduals to continue living in their own policy/telemedicine/index_en.htm this technology. This article reflects on the environment, with higher levels of self- 3. Commission of the European authors’ own experience in using telemon- care. Communities. Telemedicine: Commission itoring for patients whose predominant Adopts Plans to Help Doctors and Patients The remote monitoring of patients (tele- medical problem is heart failure. Access Healthcare from a Distance. monitoring) is challenging, not least Brussels: Information Society, Commission of the European Communities, 2008. Available at http://ec.europa.eu/ Jillian Riley is Head of Postgraduate Education (Nurses and Allied Professionals) at the information_society/newsroom/cf/ Royal Brompton & Harefield NHS Trust, London, UK. Martin Cowie is Professor of itemlongdetail.cfm?item_id=4465 Cardiology at Imperial College, London, UK. Email: [email protected]

15 Eurohealth Vol 15 No 1 CHRONIC DISEASE MANAGEMENT

Traditional models of chronic disease Figure 1. management External monitoring device Chronic diseases are, almost without exception, characterised by acute exacer- bations. It is during one of these acute events that the patient is likely to present either to their primary care physician feeling generally unwell or to the emer- gency department of the local hospital. The trajectory of chronic illness then becomes marked by increasingly shorter periods of stability between acute exacer- bations. To assist in the early recognition of the often subtle signs and symptoms of deterioration regular follow-up with a information is transmitted from the patient Most studies report more than 80% health professional is encouraged. In (usually in their home) to the health compliance of patients with telemoni- primary care based health services (such as professional. The transmission can be toring, regardless of duration of moni- in the United Kingdom) this regular relayed in real time (synchronous), or toring or age. In our own experience in an follow-up is provided by the general prac- asynchronously where the information is elderly, multiethnic, metropolitan area, titioner, with secondary care clinic visits stored and forwarded for review later. In poor compliance with monitoring is rarely only at six to twelve month intervals. The most cases, data are transmitted using the an issue, particularly with good family effectiveness of this model relies upon domestic telephone line, although within support.5 good communication between the patient, the home, data may be transmitted wire- More recently more rigorously designed primary and secondary care, and the many lessly from the monitoring device to a unit randomised studies have been undertaken. other professionals involved (primary care plugged into the telephone line. These are likely to be much more influ- physician and practice nurse, community The monitoring technology can vary in ential on the clinical community than the pharmacist, and the hospital specialist complexity from simple monitoring of earlier observational studies. Paré and medical consultant and nurse). such physiological data such as blood colleagues undertook a review of all high Multidisciplinary disease management pressure, pulse, blood oxygen level, blood quality randomised trials of home tele- programmes, frequently led by a specialist sugar or body weight, to implantable monitoring in chronic illness undertaken nurse in secondary care, have developed to devices (such as heart pacemakers or defib- before 2006.6 Identifying a total of sixty- optimise management of chronic condi- rillators) whose functions can be moni- five studies in a variety of chronic condi- tions such as diabetes, chronic airways tored remotely, and in some cases also tions (diabetes, hypertension, heart and disease, or heart failure. Such programmes reprogrammed remotely. Very sophisti- lung disease) they were able to conclude provide education to facilitate self-care cated implantable monitors that can that telemonitoring consistently provided (including monitoring), ensure appropriate measure the pressure within heart the health professional with accurate data uptitration (dosage raising) of drug chambers or large blood vessels, or the on which to plan care, but there were therapy, and facilitate collaboration within amount of water in the lungs, can also be inconsistencies in its effect upon health the multidisciplinary team. This approach monitored remotely. This adds to the care utilisation and overall patient is recommended in current international physiological data that can be provided to outcome. clinical guidelines.2–4 a health care practitioner to facilitate better Turning to the literature specifically related management of the underlying heart Many patients are elderly and their to heart failure management, Clark and condition. decreased mobility and lack of social colleagues undertook a review where they support is likely to impact upon clinic Figure 1 shows an example of a commer- combined the results of five randomised attendance. Home-based models of care cially available external monitoring device trials of telemonitoring using equipment can circumvent this problem but are costly that measures weight, blood pressure, external to the patient.7 The combined in terms of travelling time for the health oxygen saturation and also transmits the results suggested an impressive reduction care professional. This reduces the number patient’s responses to a series of questions in the risk of death of around 40% with of patients that can receive care. Telemon- about changes in their symptoms. telemonitoring compared with usual care, itoring offers the promise of enabling such with the absolute risk of death being of the professionals to extend the reach of disease Clinical benefits order of 20% in patients in the control management programmes, ensure more Much of the early support for telemoni- arms of the studies, which followed up appropriate use of health care resources, toring comes from observational studies, patients for three to fifteen months. In and provide care at a time and place more without appropriate comparator groups. addition, they reported a trend towards a convenient to the patient. Such studies are likely to overestimate the reduction in hospitalisation (for any cause) clinical effect of the technology, but do at in patients who were telemonitored, What is telemonitoring? least provide firm evidence that the although this result could have arisen by Telemonitoring (‘remote monitoring’) commercially-available platforms are chance (P value >0.05). An important refers to patient monitoring where the physically robust, relatively easy to install caveat to this overview is that the studies patient and health care professional are and operate, and largely acceptable to both included tended to recruit relatively young separated by geographical distance. The patients and health care professionals. and highly motivated patients with

Eurohealth Vol 15 No 1 16 CHRONIC DISEASE MANAGEMENT advanced disease and, importantly, with develop out of relationships with new 3. European Respiratory Society. Guide- fewer coexisting illnesses (comorbidities). service providers such as “call centres”. lines For The Management of Chronic This makes it difficult to extrapolate the Working across a plurality of providers is Obstructive Pulmonary Disease. Lausanne: findings to the general population. new within many health care systems, ERS, 2009. Available at including those in the UK. To be effective, http://www.ersnet.org/lrPresentations/cop More recently, we reported on the Home- an integrated and coordinated strategy is d/files/main/index.html HF (Heart Failure) study in a general heart required that works across these different 4. Scottish Intercollegiate Guidelines failure population of elderly patients (with agencies and has clearly identified lines of Network. Management of Diabetes. A a mean age of 71, 45% >75 years) where communication and responsibility. National Clinical Guideline. Edinburgh: we compared six months of daily telemon- SIGN, 2001. Available at 5 itoring with specialist heart failure care. These changes bring perceived threats to http://www.sign.ac.uk/pdf/sign55.pdf Whilst demonstrating no difference in traditional professional roles. The hospitalisation (for any cause) we found potential for a non-professional, protocol 5. Dar O, Riley J, Chapman C, et al. A randomised trial of home telemonitoring in strong evidence that emergency room driven approach to the initial patient a typical elderly heart failure population in visits, clinic reviews and unplanned hospi- assessment and triage may restrict the North West London: results of the Home- talisations for heart failure were reduced. identification of relevant nuances in the HF study. European Journal of Heart This confirms the feasibility of detecting patient history. Telemonitoring also has the Failure 2009; 11(3):319–25. decompensation of chronic heart failure potential to increase patient contact with syndrome early and making health care the specialist, possibly at the expense of 6. Paré G, Jaana M, Sicotte C. Systematic interventions in a planned manner as a contact with the primary care physician. In review of home telemonitoring for chronic disease: the evidence base. Journal of the result of daily physiological data trans- health care services such as those in the American Medical Informatics Association mission to a specialist heart failure nurse. UK, where primary care acts as the first 2007;14:269–77. The outcome was similar to that provided point of contact and is responsible for by traditional specialist heart failure care, deciding when and whom to refer for 7. Clark R, Inglis S, McAlister F. Telemoni- but the specialist nurse was able to monitor specialist advice, this raises reimbursement toring or structured telephone support considerably more patients than was usual. issues that have yet to be resolved. Where programmes for patients with chronic telemonitoring centres operate outside of heart failure: systematic review and meta- analysis. British Medical Journal The patient perspective traditional professional health care services 2007;334:942–51. Qualitative research provides interesting then commissioners need robust arrange- insights into patients’ perceptions of health ments to ensure patient safety and the 8. Boyd KJ, Murray SA, Kendall M, Worth care. Patients with chronic medical condi- continued delivery of high quality care. A, Benton TF, Clausen H. Living with tions (and their families) often feel over- advanced heart failure: a prospective, burdened with the responsibility of care Conclusion community based study of patients and and frustrated by the difficulty of navi- Telemonitoring offers much promise. It their carers. European Journal of Heart Failure 2004;6:585–91. gating the health care system. Whilst they has been shown to be technically feasible know the signs and symptoms to observe, and user friendly and is acceptable to 9. Rogers AE, Addington-Hall JM, Abery they find it difficult to identify relatively patients with chronic disease. It signifi- AJ, et al. Knowledge and communication subtle changes which may warn of an cantly increases the number of patients difficulties for patients with chronic heart impending acute exacerbation. Conse- that can be cared for and facilitates timely failure: a qualitative study. British Medical quently they delay seeking professional intervention to resolve health issues. When Journal 2000;321:605–7. help.8,9 Telemonitoring may have an problems cannot be resolved remotely, it important role in supporting people to enables good use of health care resources gain confidence in living with and through appropriate scheduling of outpa- managing chronic disease. tient clinic review, a home visit or even a hospital admission. However, it changes Our experience with patients using tele- traditional working practices and requires monitoring suggests the direct link the flexible organisation of health care. between them and the health professional These challenges must be overcome if tele- provides reassurance that any important monitoring is to fit seamlessly into the change will be rapidly identified and landscape of health care. management commenced promptly. Tele- monitoring also increases patients’ under- standing of how to manage their REFERENCES symptoms and results in many feeling more in control of their heart failure 1. Currell R, Urquhart C, Wainwright P, management. Patient satisfaction with this Lewis R. Telemedicine versus face to face approach to care is high. patient care: effects on professional practice and health care outcomes. Cochrane Database of Systematic Reviews 2000;2. The changing geography of health care Telemonitoring challenges traditional 2. Dickstein K, Cohen-Solal A, Filippatos health care practice. Whilst it can be inte- G, et al. ESC Guidelines for the diagnosis grated into established primary or and treatment of chronic heart failure 2008. secondary care services, it may also European Heart Journal 2008;29:2388–442.

17 Eurohealth Vol 15 No 1 HEALTH POLICY DEVELOPMENTS EU cross-border health care proposals: implications for the NHS

Helena Bowden

Summary: In July 2008, the European Commission brought forward proposals for an EU Directive on patients’ rights in cross-border health care. The NHS European Office carried out a consultation exercise to assess potential implications of the proposed legislation for the UK National Health Service (NHS). This article discusses the outcomes from the consultation and considers how proposed provisions on cross-border health care could have consequences in two areas of domestic health policy.

Key words: Cross-Border Health Care, NHS, Patient Mobility, Entitlements, UK

The European Commission published certain rights in relation to cross-border proposals would have no impact on the proposals on patients’ rights to cross- health care. NHS. The draft directive is intended to border health care in July 20081 with a fully respect national governments’ However, there are a number of uncer- view to “help patients in getting the health responsibilities for the organisation, tainties around case law that make it care they need, and help Member States management and funding of health care. difficult to implement in practice. For ensure the accessibility, quality and However, the consultation identified a example, it is not clear when reim- financial sustainability of their health number of areas where there is the bursement of health costs abroad can be systems and the well-being of their potential for confusion and/or conflict made subject to the patient having first citizens.”2 between the current proposals and present sought ‘prior authorisation’ from their NHS policy. This article discusses two However, a mechanism for patients to home health system. The draft directive areas where the draft directive’s proposed obtain planned treatment in another EU seeks to clarify the present situation, for approach does not reconcile easily with country at the expense of their home the benefit of both patients and those existing NHS arrangements. health care system already exists under managing health services. longstanding EU regulations on the coor- Entitlements 3 dination of social security schemes (the Will it make any difference to the NHS? The draft directive aims to ensure that ‘E112 referral’). Department of Health The NHS European Office undertook a patients can access the same health care figures show that very few patients from major consultation process with the aim of entitlements in other EU countries as at England, Scotland and Wales have been assessing the potential implications for the home. The principle is simple but the 4 treated under these arrangements. Data NHS of the proposals set out in the draft reality is more complex, in particular in 6 on patient flows between Northern directive. Whilst it is impossible to predict systems like the NHS that do not have Ireland and the Republic of Ireland also how patterns of cross-border health care defined lists of care to which patients are indicates low levels of cross-border will change in the future, overall, most automatically entitled. activity.5 So why is a new directive on NHS organisations did not anticipate a cross-border health care needed, and will large expansion in the volume of cross- Access to specialist care in the NHS is by it really make any difference to the NHS? border health care, either to or from the referral from primary care and decisions UK, within the framework of the draft about an individual’s care are usually taken Why is it needed? directive. by their NHS clinician, where relevant taking into account, or with reference to, The draft directive follows a succession of In general, the NHS view was that cross- local commissioners’ (the NHS equivalent cases in the European Courts of Justice border patient flows arising from a future to an ‘insurer’ in the context of cross- (ECJ), where individuals have sought directive would not have a significant border health care) guidance on low reimbursement for health care received in impact on the NHS’ ability to manage and priority treatments. another EU country. Taken together these deliver health services for the UK popu- cases have established that patients have In light of this, NHS organisations noted lation, particularly in comparison to the that if a patient sought treatment abroad impacts of wider phenomena such as demo- Helena Bowden is European Policy without a needs assessment from their graphic change and migration patterns. Manager, NHS European Office, Brussels, local NHS, it may be extremely difficult to Belgium. The absence of large cross-border patient determine retrospectively whether Email: [email protected] flows does not, however, mean that these treatment would have been available under

Eurohealth Vol 15 No 1 18 HEALTH POLICY DEVELOPMENTS the NHS, and therefore, whether the for specialist care are able to choose to be eligible for and what costs they will have patient is eligible for a reimbursement. seen by any NHS provider that provides to meet themselves, arrangements for any appropriate treatment. Many English after-care needed and what will happen if A further complexity arises because of the NHS organisations viewed the proposals anything goes wrong, such systems would difficulty in determining what constitutes on cross-border health care to some degree enable patients to make an informed the same treatment in another health care as an extension of ‘patient choice’. The choice about the best health care option for system, for example because differences in NHS view was, therefore, that where it has them. clinical practice may exist. The draft been established that a patient is eligible to directive attempts to overcome this by The NHS view was that the draft directive receive a particular treatment, the fact that defining the right to reimbursement with was short-sighted as it did not recognise health care could be provided locally reference to the costs which would have the potential benefits to patients of prior should not, alone, be a reason to prevent been paid had the “same or similar” health authorisation systems, and in proposing the patient from seeking treatment abroad. care been provided within the patient’s that prior authorisation systems could home system. However, one key difference between only be used in exceptional circumstances. patient choice in England and cross-border NHS organisations felt that the simplest The NHS view was that such an approach health care is that patient choice is limited and clearest approach to prior authori- could be interpreted as contradicting the to providers contracted to the NHS. This sation systems would be for each country principle that entitlement is limited to that includes a range of independent and third to develop its own list of health care for which patients can receive at home. A sector providers (for example, charitable or which prior authorisation is required, patient might seek a treatment in another voluntary sector organisations), but whilst ensuring that prior authorisation country that their home system does not crucially, all are required to provide health systems are clear, user-friendly and fund and argue that they should be reim- care according to NHS standards and responsive. bursed because it is ‘similar’ to a treatment conditions, including, for example, taking they were receiving at home. Such a system As levels of cross-border health care to and into account relevant clinical guidelines. could lead to numerous disputes between from the UK have, to date, generally been ‘cross-border’ patients and their home By contrast, in a cross-border situation, a relatively low, few local NHS organisa- health care systems. It could also result in patient can access treatment from any tions currently have the knowledge and patients who cannot, or do not wish to, health care provider, private or state/public expertise to be able to advise patients inter- access cross-border health care, being sector and without reference to issues such ested in cross-border health care. The unfairly disadvantaged. as compliance with quality and safety stan- development of systems to support and dards and clinical guidelines. NHS organ- facilitate cross-border health care will These problems could be avoided by clar- isations were concerned that this implied a therefore have resource implications. ifying the draft proposals, with regard to greater degree of risk in cross-border the limit on entitlements and also by The NHS view was that prior authori- health care, of which patients may not even recognising different mechanisms for sation and information systems would be a be aware. determining eligibility in the text. Even necessary investment. However, it is with such clarifications, NHS organisa- NHS organisations considered that, in essential that information and data tions will need to ensure that patients can order to reduce such risks, it would be collection requirements remain propor- easily access information about processes essential to ensure that patients consid- tionate, and the NHS view has been that used to determine eligibility, and that deci- ering cross-border health care obtain clear the focus should be on enabling patients to sions about entitlements are reached and information on the conditions that apply make informed choices, for example by communicated to them clearly and before they seek treatment abroad. As this highlighting what questions they might promptly. This is likely to pose a particular will need to include personalised infor- ask of a potential health care provider. It is challenge in relation to cases where mation on a patient’s individual needs and important to avoid a situation where patients apply for a treatment not usually entitlements, the NHS view was that there potential cross-border patients are entitled funded or challenge a decision not to fund should be a process for patients to consult to more information and support than a treatment, when a longer timescale may their local NHS before obtaining cross- domestic patients seeking care at home. be needed for a decision to be made. border health care. Conclusions There is currently significant variation in NHS organisations felt the logical way of The NHS European Office’s consultation the way local NHS organisations reach achieving this was to put in place prior on the European Commission’s proposals and review decisions about entitlements. authorisation systems. Such systems were on patients’ rights in cross-border health In the context of work to define an NHS not viewed as a barrier to cross-border care found that NHS organisations did not Constitution,7 a statement of the NHS’ health care, as it was expected that autho- fear a large amount of cross-border health core values and patients’ rights and respon- risation would generally be granted, with care as a result of potential new legislation sibilities, there are moves towards refusals only in exceptional circumstances in this area. However, there were concerns improved standards and greater trans- (for example, if there was a risk to wider about potential clashes between the parency in local decision-making, which public health associated with the patient proposals and domestic policies, and these will be important in the context of cross- travelling for treatment). These systems issues should receive full consideration. border health care. were also seen as an important way of protecting patients’ interests. By providing Ultimately, the extent to which the cross- Patient choice clarity on matters, such as what specific border proposals will impact on the NHS Under the policy known as ‘patient treatment their clinician recommends for and its patients will depend on the final choice’, NHS patients in England referred them, what reimbursements they will be shape of the directive if and when it is

19 Eurohealth Vol 15 No 1 HEALTH POLICY DEVELOPMENTS adopted, and how it is then implemented at national level. The NHS European Promoting a sustainable Office will continue to work with NHS organisations to further assess the draft directive as the legislative process workforce for health in continues, and to inform EU policy- makers of potential implications for domestic health care systems. Europe

REFERENCES 1. Commission of the European Commu- nities. Proposal for a Directive on the Application of Patients' Rights in Cross- Elizabeth Kidd border Health Care. Brussels: Commission of the European Commu- nities, 2008. Available at http://ec.europa. eu/health/ph_overview/co_operation/healt Summary: The European Union's health care workforce is both ageing and h care/docs/COM_en.pdf increasingly mobile, so Member States need to plan human resources for health 2. Directorate-General Public Health. with this in mind. On 10 December 2008, the European Commission published a New Commission Initiative on Patients’ Green Paper on this topic and launched a public consultation. This has sought Rights in Cross-border Health Care. stakeholders' views are on a wide range of issues connected with the health care Brussels: Commission of the European workforce and preparing for the care of an ageing population. The results of the Communities, 2008. Available at consultation will advise what the EU can do to support Member States. http://ec.europa.eu/health/ph_overview/ co_operation/healthcare/proposal_ directive_en.htm Keywords: workforce, sustainable, consultation, mobility, strategies 3. Consolidated version of Council Regu- lation (EC) No. 1408/71 on the application of social security schemes to employed persons, to self-employed persons and to On 10 December 2008, the European an ageing Europe by promoting good members of their families moving within Commission published a Green Paper on health throughout the lifespan, by the Community. Official Journal of the the EU Workforce for Health.1 This publi- protecting citizens from health threats, by European Union 2006. Available at: cation launched a consultation period, improving patient safety and by http://eur-lex.europa.eu/LexUriServ/site/ running until the end of March 2009, supporting dynamic health systems and en/consleg/1971/R/01971R1408- which aims to identify common responses new technologies. 20060428-en.pdf to the many challenges facing health and However, making progress on these objec- social care systems in Europe, as well as 4. Winterton R. Answer to question on tives cannot be made without a workforce the workforce solutions required to tackle health services: reciprocal arrangements. of sufficiently well-trained and highly Hansard 2007, 20 June (pt 0029), Column them. motivated health professionals and care 1913W. Available at: http://www.publica workers, equipped with the right skills and tions.parliament.uk/pa/cm200607/cmhansr Why a Green Paper? located in the right places. While each EU d/cm070620/text/70620w0029.htm The health systems of the European Union Member State is in charge of its medical are the building blocks of Europe's high 5. Jamison J, Legido-Quigley H, McKee infrastructure there have been growing levels of social protection. Health systems M. Cross border health care in Ireland. In: concerns throughout the EU about health are an intrinsic component of social Rosenmoeller M, McKee M, Baeten R workforce numbers and the sustainability (eds) Patient Mobility in the European welfare and they contribute to social of dynamic health systems. Union. Learning from experience. Copen- cohesion and social justice, as well as to hagen: World Health Organization, 2006. sustainable development. The European Responding to the challenges Commission's health strategy adopted in 6. NHS European Office. A European EU health systems have to perform a October 2007 and published in the White Health Service? The European difficult balancing act, firstly between the Paper Together for Health2 put forward a Commission’s Proposals on Cross-border increasing demands on their health services new approach to ensure the EU could do Health Care. Brussels: NHS Confeder- and constraints on supply and secondly ation, 2008. Available at as much as possible to tackle challenges between the need to respond to population http://www.nhsconfed.org/NationalAnd such as health threats, pandemics, the health needs locally alongside the need to International/NHSEuropeanOffice/KeyIs burden of lifestyle-related diseases, be ready for major public health crises. sues/Pages/CrossBorderHealthcare.aspx inequalities, EU enlargement and climate 7. Department of Health. The National change. It aimed to foster good health in There are a number of challenges facing Health Service Constitution, 2008. London: Department of Health, 2008. Available at http://www.dh.gov.uk/en/ Elizabeth Kidd is based at the Health Strategy Unit, European Commission, Brussels, Publicationsandstatistics/Publications/Pub Belgium. She is a UK National Expert on secondment from the Department of Health. licationsPolicyAndGuidance/DH_085814 Email [email protected]

Eurohealth Vol 15 No 1 20 HEALTH POLICY DEVELOPMENTS health systems in Europe. Policy makers cope with training for new treatments and 20034 indicated that an estimated 15,000 and health authorities first of all have to technologies? qualified nurses and midwives were living adapt their health care systems to cater for in Ireland but opting not to work in the By describing as precisely as possible the an ageing population. Between 2008 and profession. When asked why they left the common challenges faced by the EU 2060 the population of the EU-27 aged nursing profession, almost 40% said that health workforce: demographic change, sixty-five and over is projected to increase their decision to leave was affected by diversity in the health workforce, the by sixty-seven million, while those over conditions in their working environment, limited appeal of many diverse health care eighty will be the fastest growing segment such as understaffing, working hours, and public health related jobs to new of the population.3 The introduction of management problems and poor resources. generations, the migration of health new technology is also making it possible When asked if they would consider professionals in and out of the EU, to increase the range and quality of health unequal mobility within the EU, as well as returning to nursing if more attention was care in terms of diagnosis, prevention and the health brain drain from other coun- paid to working flexibly, 53% said they treatment, but this has to be paid for and tries, the Green Paper aims to increase the would. staff need to be trained to use it. political visibility of these issues. The key to maintaining a sufficient work- Furthermore, there are also new and re- force, in the face of the impending emerging threats to health, for example It signified the launch of a debate and, by retirement of the ‘baby boom’ generation, from communicable diseases. Finally, engaging stakeholders, the consultation is not only to retain and recruit both citizens have ever-rising expectations on process has aimed to identify where the young and mature workers but also to access to the best possible health care. All Commission believes further action can be embrace flexible working arrangements. of these factors inevitably lead to contin- undertaken to stimulate coordinated Recruitment campaigns can take advantage ually rising spending on health and indeed approaches. In light of the fact that of the growth in the proportion of those pose major long-term challenges to the Member States are facing a number of over fifty-five. ‘Return to work’ campaigns sustainability of health systems in some common problems with their health work- can be aimed at those who may have with- countries. forces, there is much to be gained by promoting cooperation and common drawn from the health care sector for some Health services are extremely labour approaches between Member States. time due, perhaps, to family commitments. intensive and health workers in the widest Special training courses will be needed to sense constitute one of the most significant Next steps – building the workforce help these applicants back into the work- sectors of the EU economy, providing The Green Paper intends to highlight the place. employment for one in ten of the EU need for forward thinking, collaboration Attracting students to health-related workforce. However, there are serious and imaginative use of robust human studies, coupled with attracting workers to issues facing the health workforce in the resource strategies to build capacity in the participate in this sector will be a major EU. Many of these problems are common health workforce. challenge, especially as there is compe- to all Member States. The ageing popu- tition in the labour market from jobs often lation means that the health workforce is Good human resource planning and offering better wages and working condi- itself an ageing one and there are insuffi- management have a vital role to play in the tions. Strategies need to be geared towards cient recruits coming through to replace recruitment and retention of staff. Staff are the diversity of the modern European those people leaving. This and the growing not motivated to stay in employment population, both in terms of the flexibility pressures on health systems mean that solely by their rates of pay, although of conditions of service, but also culturally there are already shortages in many health clearly it is an important factor. Staff need sensitive to the needs of ethnicity and reli- professions. Migration of health profes- to feel valued and will feel valued if they gious customs. sionals in and out of the EU, as well as work in a culture which promotes partici- mobility within and outside the EU, also pation in decision making, team working The challenge of increased mobility has the effect of increasing shortages in and opportunities for career development. Many of the countries which have joined some regions. Employees are increasingly aware of potential benefits, educational opportu- the EU since 2004, have witnessed an So, how can high standards be ensured nities and employment options. exodus in their health professionals. They when health professionals move between have voiced concerns about the implica- All staff need to be supported in the countries with very different health tions of the internal market and EU work/life balance; attention to these systems? How can the growing demands Directive 2005/36, which provides for the factors plays an important part in both for health care be met in the light of free movement of professionals and the recruiting and retaining staff. It can even shortages resulting from the ageing and mutual recognition of professional qualifi- help in attracting them back to work if increased mobility of the health work- cations. they have left the profession. Strategies can force? How do countries with less include job-sharing, holiday play schemes However, freedom of movement of people economic resource in the EU retain the for children of working parents, maternity, between Member States is a key part of the health professionals they train when their paternity and special leave arrangements, construction of the EU. Mobility of health health systems cannot compete with as well as potential alternatives to early- professionals is useful. It means that health higher salaries in other parts of the EU? late-early shift patterns. workers can go where they are most What ethical issues arise when the EU needed and can move to obtain more seeks to solve these problems by attracting Here is an example, by no means isolated, professional experience. There is also, of health workers from low and middle- of how the quality of working life plays an course, migration outside the EU. income countries? How do we ensure important role in influencing decisions to sufficient capacity in all specialties and leave jobs in nursing. In Ireland a study in As is widely acknowledged, a serious

21 Eurohealth Vol 15 No 1 HEALTH POLICY DEVELOPMENTS impediment in analysing the workforce their pay and working conditions. The present opportunities. With many jobs situation across the EU is the lack of up- creation of an EU-wide forum or platform being lost in all sectors of the wider to-date data and information. We do not where managers could exchange experi- economy and unemployment levels rising have comparable qualitative or quantitative ences might merit value in this context. across the EU, health and care sector EU-wide data on the number of health employers will have a rare opportunity to workers in training or employment, their Training offer retraining to some being made specialisations, geographical spread, age, Graduates and school leavers need to be redundant from commerce and manufac- gender and country of provenance. aware of the rich diversity of career oppor- turing and so draw on a new pool of Instead, we work with proxy data tunities available in the health and caring potential talent. The question is, will this collected from applications to register with professions. More mature workers, those opportunity be seized? competent authorities in the Member returning to work after home responsibil- States. These requests are indicators only ities or those who want to change career, of intention and cannot provide details on can be encouraged to join if specially REFERENCES whether the health professional actually adapted training courses are available. In 1. Commission of the European Commu- left for the new country or if, having left, some parts of Europe training programmes nities. Green Paper on the European Work- they returned. It is also virtually impos- may need to be designed to attract people force for Health. Brussels: Commission of sible to track out-flow and in-flow when from ethnic minority backgrounds into the the European Communities, 2008, COM the health worker does not take up a workforce for health so that it more accu- 725. Available at http://ec.europa.eu/health similar position as a regulated professional rately reflects the makeup of the popu- /ph_systems/docs/workforce_gp_en.pdf in the destination country. While there are lation served. This will help to ensure that 2. Commission of the European Commu- some exciting and promising research services can be designed to be culturally nities. White Paper. Together for Health: A projects now underway, funded in part by sensitive and help to increase equity of Strategic Approach for the EU 2008–2013. the EU, it will be some time before we access to health service for migrant and Brussels: Commission of the European have access to robust data and information. ethnic communities. Communities, 2007, COM 630. Available at http://ec.europa.eu/health/ph_overview/ The response to tackling the effects of As well as initial training, the issue of Documents/strategy_wp_en.pdf increased mobility must surely be to health professionals' continuing profes- address these issues through appropriate sional development (CPD) is also 3. Eurostat. Population Projections for EU policies, such as measures to increase important. It is through the record of CPD Member States 2008. Luxembourg: general labour market participation, in that a prospective employer can tell how Eurostat, 2008. particular in respect of women, older up-to-date a professional's skills and 4. Egan M, McAreavey D, Moynihan M. workers and young people; improved knowledge are. CPD helps to demonstrate An Examination Of Non-Practising Qual- workforce retention; further improve- the value of a health worker to the organ- ified Nurses and Midwives in the Republic ments to education and vocational isation being served. It is also useful to the of Ireland and an Assessment of their training; adequate conditions of employing organisation as part of its Intentions and Willingness to Return to employment for public sector workers; performance management system because Practice. Dublin: Irish Nurses Organi- incentives for return mobility; and the updating of professional skills has a sation and the Michael Smurfit Graduate measures to facilitate internal labour part to play in both improving the quality School of Business, 2003. Available at http://hse.openrepository.com/hse/ mobility. This response also will include of health outcomes and ensuring patient bitstream/10147/44920/1/6640.pdf managed immigration from outside the safety. One dividend is improved morale EU. and staff retention. Further related information on EU health workforce issues can be found at Member States will gain from collabo- Finally, it may be useful to reflect on the http://ec.europa.eu/health/ph_systems/ rating with other Member States rather implications of the current economic crisis, workforce_en.htm than being in competition with each other. which, while bringing pain, may also Cross-border agreements on training and staff exchanges may help to manage the outward flow of health workers. Incen- Financial Crisis and Health Policy tives to promote the ‘circular’ movement of staff could be introduced, by which the 12th European Health Forum Gastein benefits of working in another health 30th September to 3rd October 2009 system would be recognised, while encouraging eventual return to the home The global financial downturn poses clear challenges for health and health systems. country. Incentives could take the form of Yet this is a time to reinforce not retreat from investments in health. This year's an agreed career pathway, so that the indi- conference will address challenges and opportunities for health systems, population vidual returning may come back to a post health and the health of individuals and aims to develop appropriate policy responses and receive a salary which recognises the to be considered at national and EU levels. experience gained. I Impact of the financial crisis on health International Forum Gastein Tauernplatz 1, The increased mobility of the workforce I Health inequalities in Europe 5630 Bad Hofgastein may require workforce managers at local I Sustainable health care Austria Tel: +43 (6432) 3393 270 and/or national level to review the I Health Technology Assessment Email: [email protected] adequacy of their recruitment and profes- I Transferring good practice into action Web: www.ehfg.org sional development measures, as well as

Eurohealth Vol 15 No 1 22 HEALTH POLICY DEVELOPMENTS The pharmaceutical sector in the Republic of Srpska, Bosnia and Herzegovina

Vanda Markovic Pekovi´c,Ranko Skrbi´cand Nataša Grubiša

Summary: Medicines are one key component in the maintenance and restoration of the health of communities and individuals, which is why they are placed amongst the top priorities in the health system of the Republic of Srpska, one of the two entities that make up Bosnia and Herzegovina.. This is being achieved through the development of a national medicines policy. A central objective in the area of pharmaceutical activity to ensure that citizens have access to safe, good quality and effective medications that are made available at reasonable price and used in a rational manner.

Keywords: pharmaceutical policy, drug regulatory agency, Republika Srpska, Bosnia and Herzegovina

Republika Srpska, or the Republic of line with countries in the region in terms The Pharmaceutical Chamber and the Srpska (RS), is one of two entities in of the consumption of resources for health Pharmaceutical Association. Bosnia and Herzegovina, (the other being care.3,4 While the use of medications has the Federation of Bosnia and Herzegovina increased across all of Bosnia and Herze- Developments in the pharmaceutical – FBH) accounting for 49% of the land govina, it is noticeable that the share of sector mass of the country and home to about total consumption in RS compared to Pharmaceutical supply during the war and 34% (1.5 million) of the population. It has FBH has increased considerably (Table 2). postwar period was mostly channelled its own executive and legislative functions Per capita pharmaceutical expenditure in through humanitarian aid programmes, and responsibilities, including those RS increased from €28 in 2005 to €50 in which thus heavily influenced pharma- covering health care policy.1,2 As indicated 2007. cotherapy, with medicines delivery based in Table 1, the declining birth rate coupled upon humanitarian donors own estimation Authority over the health system in RS is with the increase in life expectancy and and stocks.7 Since the 1990s the pharma- centralised, with planning, regulation and proportion of the population aged sixty- ceutical sector has undergone much management functions held by the five and older indicates a need, common to reform, both through EU CARDS Ministry of Health and Social Welfare. The that seen in many other parts of Europe, programme (Community Assistance for Health Insurance Fund (HIF) provides for the health care system to shift towards Reconstruction, Development and Stabili- universal health insurance coverage for the better prevention and management of sation) and various World Health Organi- population and operates on the basis of chronic disease, as well as increased zation (WHO) projects which have solidarity and mutuality. It is the only provision of geriatric and long-term care supported health care reforms in Bosnia body legally responsible for the collection services. and Herzegovina. and allocation of financial contributions to Spending approximately 6% of its GDP health care providers. Two independent Marketing authorisation, quality control on health care in 2006, RS is coming into professional pharmacy organisations exist: and inspection improved considerably in 1997 when the List of Essential Medicines was introduced, based on the WHO’s Vanda Markovic Pekovi´cis a pharmacist based at the Ministry of Health and Social Essential List Model. Further improve- Welfare, Republic of Srpska, Banja Luka, Bosnia and Herzegovina. ments came with the creation of a pharma- Ranko Skrbi´cis Minister of Health and Social Welfare, Republic of Srpska, Bosnia and ceutical department within the Ministry of Herzegovina. Health and Social Welfare and the Nataša Grubiša is a pharmacist at the Drug Regulatory Agency of Republic of Srpska, appointment of a junior minister with Banja Luka, Bosnia and Herzegovina. responsibility for pharmaceutical issues. Email: [email protected] There has been a strong orientation

23 Eurohealth Vol 15 No 1 HEALTH POLICY DEVELOPMENTS towards the EU, aligning pharmaceutical Table 1: Overview of demographic indicators, Republic of Srpska legislation with EU directives. Legislation harmonised according to European stan- Indicators 1998 1999 2006 dards provides the basis for maintaining standards for the quality assurance of Population (millions) 1.43 1.45 1.49 medicines. The current applicable Law on Medicines, approved by the Parliament in % population 65+ 11.0 16.0 17.6 2001, was developed by local experts through the EU CARDS Programme, and Birth rate (per 1,000 population) 9.4 10.0 7.7 was fully compliant at that time with European pharmaceutical legislation. This Death rate (per 1,000 population) 8.7 8.5 9.3 law was subsequently revised and updated in March 2008. Other specific aspects of Life expectancy at birth (female) 74 74 82 pharmaceutical policy are covered through a number of bylaws. Life expectancy at birth (male) 71 71 75 An official national medicines policy document, linked to overall health policy, Infant mortality (per 1,000 live births) 8.3 8.2 4.3 was adopted by the government in 2006. Its overall objective is to ensure access to Sources: Republika Srpska Institute of Statistics, 20071; Cain J et al, 20025; US Central Intelligence Agency6 effective, safe and quality medicines, made available in a rational and cost-effective manner to the whole population. This Table 2: Medicines consumption in Bosnia and Herzegovina, and relative share of consumption by objective will be fulfilled through strategic the two entities action plans. Total medicine consumption in Republic of Srpska Federation of Bosnia and Year The Drugs Regulatory Agency Bosnia & Herzegovina (million €) (%) Herzegovina (%) One of the main outcomes of the WHO 75 and EU CARD projects was the adoption 2003 115 25 of the Law on Medicines and the estab- 73 lishment of the Drug Regulatory Agency 2004 123 27 (DRA) of the Republic of Srpska. The role 70 of the DRA is clearly reflected in the Law 2005 132 30 on Medicines, by which it was established 65 in 2002 as an independent professional 2006 148 35 body responsible to the minister of health. All core pharmaceutical quality assurance 2007 174 40 60 functions fall under the auspices of the DRA, i.e. marketing authorisation, classi- fication of medicines, licensing, quality them (both spontaneous reporting and Distribution, supply and quality control control, medicines information, pharma- within clinical trials). A brochure entitled The majority of medicines are imported, covigilance and clinical trials. It has a staff Guidelines for Detecting and Reporting the with the majority coming from manufac- of forty employees, the majority of whom Adverse Effects of Medicines has also been turers elsewhere in the former Yugoslavia, are pharmacists. Since the DRA was estab- published and reports can be submitted as well as from multinational pharmaceu- lished, an upward trend in the number of online or by post. The DRA is also respon- tical companies. There is only one local medicines that receive marketing authori- sible for monitoring clinical trials pharmaceutical manufacturer, Hemofarm, sation, in accordance with the system of according to related bylaws and guidelines now a subsidiary of the German pharma- international non-proprietary names on good clinical practice. The case for each ceutical company Stada. (INN), has been observed. This increased proposed clinical trial, including harmon- Pharmaceuticals are supplied by whole- from 104 INNs in 2005 to 260 in 2007. isation with clinical practice guidelines, is salers to pharmacies. There are twenty-five evaluated by the RS Ethical Committee. The increased number of medicines on the licensed wholesalers, all privately owned. market can be directly linked with Pharmaceutical inspection is regulated by Four wholesalers dominate, having improved access to medicines by the popu- the Law on Inspection, with an Inspec- around 80% of the market. Prescription lation. A department of pharmacovigilance torate established as the competent and over the counter medicines can only is responsible for collecting data on authority. Inspectors have the authority be obtained through the 274 pharmacies in adverse drug reactions (ADR) and for and obligation to take appropriate meas- RS, the majority of which are privately promotion of the importance of moni- ures where non-compliance with legis- owned. Pharmacies may be owned by toring and reporting of ADR. Through lation is identified. One problem however non-pharmacists, but can only be operated organised workshops the DRA provides is a shortage of pharmaceutical inspectors, by one or more of the 523 licensed phar- pharmacists and physicians with the most with only two currently in operation. macists in RS, usually working in part- relevant data on ADR, as well as demon- Moreover, neither has a Good Manufac- nership with a team of pharmaceutical strating practical skills on how to report turing Practice (GMP) qualification. technicians. One recent change has been

Eurohealth Vol 15 No 1 24 HEALTH POLICY DEVELOPMENTS the creation of specialist stores operated by Reimbursement and drug price customs tariff for pharmaceuticals ranges pharmaceutical technicians in which herbal regulation between 0% and 10%. medicines, foodstuffs, other comple- Outpatient medicines reimbursed under mentary medical products, cosmetics, the Positive List are dispensed through a Better use of medications and hygiene products and specified medical network of pharmacies contracted by HIF. strengthening human resources devices may be sold. Criteria for reimbursement are defined by A number of efforts have been undertaken the HIF. The evidence on the therapeutic to encourage the more efficient and There are 35 pharmacists per 100,000 benefits and economic impacts of medi- rational use of medications. Detailed infor- inhabitants compared with 72 per 100,000 cines are assessed by the Medicines mation on medicines are available on the in the EU.8 There is one pharmacy per Committee. Marketing authorisations are DRA website. Information tailored to 5,430 inhabitants. Density in urban areas is mandatory for all medicines but excep- health care professionals can also be found much higher than in rural areas; these tions can be made in the case of medica- in the annual Medicines Formulary. Since largely remain underserved, with pharma- tions of great clinical significance. 2006, the DRA has also begun to collect cists having little incentive to work in such data on medicine consumption, using the areas. Hospital pharmacies serve only Since May 2008 the list has comprised two ATC/DDD (Defined Daily Dosage) inpatients, again being run by licensed categories of medicine. Those on the A methodology. Eighteen standard thera- pharmacists. There remains a persistent List are fully reimbursed up to a reference peutic guidelines relating to the most shortage of hospital pharmacists while self- price level, while those on the B List are common health problems seen in primary dispensing by doctors is not allowed. reimbursed at a 50% rate. A medicine can health care have been published; others are appear on either list depending on clinical As noted earlier the Essential Medicines in preparation. Hospital Medicine indication. The A List covers medications List (EML) is based upon the WHO EML Committees can also play an important for major chronic diseases including model. The EML provides a base from role in encouraging more rational use of diabetes, epilepsy, cardiovascular disease which other outpatient and inpatient medicines. All hospitals have now estab- and chronic psychiatric problems. Medica- medicine lists reimbursed by the HIF have lished such bodies. tions for a number of severe and/or been developed. These include the chronic diseases including cancers, One key challenge is the limited capacity Hospital List of Medicines (for inpatients), HIV/AIDS, multiple sclerosis, haemo- in pharmacy. The Department of the List of Medicines used in Dom philia and hepatitis C and B are fully reim- Pharmacy within the medical faculty at the zdravljas (similar to polyclinics) by general bursed and dispensed separately through University of Banja Luka, is the only practitioners (for ambulatory acute situa- the hospital pharmacy system. teaching centre for pharmacy students. tions) and the Positive List of Medicines This is funded by the government. With (for prescription only medicines). These The reference price is set up to be equiv- undergraduate training lasting five years, lists are broader than those of the EML, alent to the cheapest generic medicine in a 120 qualified pharmacists have been reflecting therapeutic needs, but adjusted cluster, with medicines clustered on the trained in the past decade. However the to take account of the financial considera- fifth ATC level; thus medicines with the lack of teaching staff for both under- tions faced by the HIF. The WHO ATC same active ingredient (INN), dosage form graduate and postgraduate pharmacy (Anatomical Therapeutic Chemical) clas- and administration route have the same education has meant that there has been a sification system is fully applied to all price. A flat fee-for-service of €0.56 per reliance on attracting teaching staff from medication on these lists, while the prescription is paid by HIF to contracted outside RS. In future, much effort needs to Hospital and Dom zdravlja lists are also pharmacies to supply and deliver reim- be invested in expanding and training used for the central tender on the bursable medicines to patients. indigenous university staff in order to help procurement of medicines, according to Pharmacists are allowed to substitute any address the challenges created by the insuf- the Law on Public Procurement in Bosnia prescribed medicine with another that has ficient number of pharmacists having and Herzegovina. the same INN, but pharmacists are obliged professional specialisation and academic Measures to ensure the quality control of to provide the lowest priced equivalent titles, as well as the lack of hospital-based medicines are clearly set out in the Law on without any requirement for an out of pharmacists. Medicines and related bylaws. Pre- pocket payment. If there remains a marketing control testing comprises evalu- demand for a specific brand, either by the Conclusions ation of the quality element of the dossier patient or physician then the patient must Health systems should be designed so as to (sample control only if necessary) and pay out-of-pocket any difference in price. provide equitable access. The main chal- control of the first batch of medication lenge is to continue to make progress Free pricing applies to non-reimbursable prior to import. Post-marketing surveil- towards achieving key health system and OTC medicines with patients having lance involves the regular quality control objectives, namely improving the health of to pay the full retail price. A wholesale of medicines, vaccines and serums the population and providing protection mark-up of 8% is applied to the ex-factory conducted normally by the pharmaceutical against the financial costs of illness, while medicine price plus a further CIF (Cost, inspection body. There is however no ensuring financial sustainability in the Insurance and Freight) levy of approxi- government run quality control laboratory health sector. The pharmaceutical sector, mately 2%. Since 2006, Bosnia and Herze- in RS, although one is in the process of despite all its complexity, is well aware of govina has levied value added tax at a flat being established. Quality control activ- the role and the impact that it can have in rate of 17% on all imported goods, ities have thus been authorised in several meeting these objectives. including medicines. The retail mark-up is neighbouring control laboratories. 20% of the wholesale price. According to Considerable efforts have already made in Bosnia and Herzegovina legislation the RS to both improve access to medicines

25 Eurohealth Vol 15 No 1 SNAPSHOTS and make them more affordable. We have noted that access to medications has Improving child and recently been significantly improved through the development of extended hospital and outpatient positive adolescent mental health medication reimbursement lists. In the field of legislation considerable progress has been achieved in moving towards a services in Norway: regulatory framework compliant with EU standards. Effective and transparent func- tions within the DRA have made a notable contribution to the implementation of this Policy and results 1999–2008 legislation. Much more, however, remains to be done to strengthen capacity within the pharmaceutical sector. Marian Ådnanes and Vidar Halsteinli REFERENCES 1. Republika Srpska Institute of Statistics. Demographic statistics. Statistical Bulletin No 10. Banja Luka: Republika Srpska Institute of Statistics,2007. Available at In Norway, a ten year period of govern- increase in the provision of beds. Overall http://www.rzs.rs.ba/PublikDemENG.ht mental escalation in mental health services however, the emphasis of the reforms was m for children and adolescents is coming to very much on new treatment modalities: 2. Federation of Bosnia and Herzegovina an end. This snapshot gives a brief more outpatient care, ambulatory services, Federal Office of Statistics. Federation of overview of national policy and achieve- local low-threshold services and closer Bosnia and Herzegovina in Figures. ments in this period, before reflecting on collaboration between primary and Sarajevo: FBH Federal Office of Statistics, future challenges. specialist care. 2008. Available at http://www.fzs.ba/Eng/ The municipalities are considered the most index.htm The ten-year national mental health important arena for promotion and escalation plan 3. Republic of Srpska. Government. prevention. At the end of the 1990s, A Norwegian white paper issued in 1997 Economic Politics 2006. Banja Luka, 2006 municipal services were found wanting in expressed great concern about mental 4. Republic of Srpska. Government. several respects: a lack of funding, a lack of health problems among children and Economic Politics 2008. Banja Luka, 2008 skilled personnel and a lack of competence adolescents and concluded that access to regarding the planning, organisation and 5. Cain J, Duran A, Fortis A, Jakubowski mental health services of good quality was integration of services.3 The government’s E. Health Care Systems in Transition: far too low.1 The paper gave rise to a goal for the municipalities has thus been to Bosnia and Herzegovina. Copenhagen: national mental health escalation plan expand and improve the quality of European Observatory on Health Care enacted over the period 1999–2008. This Systems, 2002;4(7). Available at services. This has focused on the devel- set out a number of strategies and targets at http://www.euro.who.int/document/E786 opment of psycho-social services, cultural national, regional and local levels.2 The 73.pdf and leisure activities including ‘support- overall goal was to create adequate, contacts’ in relation to leisure-activities, 6. US Central Intelligence Agency. The coherent, well-functioning and user- more psychologists – a profession previ- World Factbook. Washington D.C: CIA, friendly services at all levels for children ously almost non-existent in the munici- 2009.Available at https://www.cia.gov/ with mental health problems. library/publications/the-world- palities, and an increase of approximately factbook/geos/bk.html. Specialist services provide diagnostic eight hundred professionals for maternal and child health centres – first and 7. Skrbic R, Babic-Djuric D, Stoisavljevic- assessment and treatment. Specific aims of Satara S, Stojakovic N, Nezic L. The role reform directed at these services included foremost public health nurses, ideally of drug donations on hospital use of an additional four hundred therapists for having undertaken postgraduate studies in antibiotics during the war and postwar outpatient clinics and a 50% increase in mental health. period. International Journal of Risk & outpatient clinic productivity, specified as Safety in Medicine 2001;14:31–40 consultations per therapist. Treatment What has been achieved? capacity was to be sufficient to cater for In specialist services a substantial increase 8. Imasheva A, Seiter A. The Pharmaceu- in treatment capacity has successfully been tical Sector of the Western Balkan Coun- 5% of the population below eighteen years tries. Health, Nutrition, and Population of age, while there was also to be a minor implemented. In respect of outpatient Discussion Paper. Washington D.C: Inter- clinics the number of therapists has more national Bank for Reconstruction and than doubled in nine years. There are now Development/World Bank, 2008. Available Marian Ådnanes is Senior Research 429 more therapists than originally at http://siteresources.worldbank.org/ Scientist and Vidar Halsteinli is Research planned. This illustrates, of course, a huge HEALTHNUTRITIONANDPOPULAT Scientist, SINTEF Health Research, increase in public spending in this sector.4 ION/Resources/281627-1095698140167/ Trondheim, Norway. The number of consultations per therapist PharmaceuticalsinWesternBalkansDP.pdf Email: [email protected] has also increased by 80%. However, one

Eurohealth Vol 15 No 1 26 SNAPSHOTS should take into account that the patient further strategic plan for the period case-mix has changed and that the policy 2003–20088 sets out how the government REFERENCES of introducing performance indicators plans to strengthen and develop actions for 1. Åpenhet og helhet. Om psykiske lidelser might have had some unwanted effects, for improved mental health among children og tjenestetilbudene. [Openness and example, in terms of inflated coding. and adolescents through one hundred Wholeness. About Mental Health Analysis indicates a 20–30 % productivity different measures. These have been imple- Disorders and the Services Offered]. Oslo: increase as being more realistic; this corre- mented within the different levels of Sosial- og helsedepartementet, White Paper sponds to the increase in the number of service, at school, in volunteer organisa- 25 1996/1997. patients per therapist.5 tions and through initiatives directed at 2. Opptrappingsplanen for psykisk helse parents. This strategic plan is an expression 1999–2006. St.prp. nr. 63 (1997/98). The increase in inpatient treatment has of intent to create a holistic approach to [Proposal to the Storting no. 63 (1997/98) been modest (forty-one more beds), enhancing child and adolescent mental Escalation Plan for Mental Health however, the development of ambulatory health. 1999–2006.] Oslo: Sosial- og helsedeparte- services in outpatient clinics has taken mentet, 1997. place and, in many cases, such services It has a clear health promotion and 3. Ministry of Health and Care Services. now represent an alternative to hospitali- prevention profile, and emphasises the Mental Health Services in Norway: sation. Capacity and productivity increases strengthening of children and adolescents’ Prevention, Treatment, Care. Oslo: imply a significant increase in access to own resources and abilities to cope with Norwegian Ministry of Health and Care services. In 2007, 4.5% of children and challenges in life. It flags up the central role Services, 1999. Available at adolescents below eighteen years made use of the local community. The plan also http://www.regjeringen.no/upload/kilde/h of specialist services. Nonetheless, points to particular challenges facing od/red/2005/0011/ddd/pdfv/233840- substantial regional differences remain part services for children and adolescents who mentalhealthweb.pdf of the picture.4 In other words, one year already have mental health problems. A 4. Bjoerngaard JH (ed). SAMDATA Sektor- before the end of the plan period, access to new strategic plan in now in development. rapprt for det psykiske helsevernet 2007. mental health services is close to, but still [SAMDATA Sector Report for the below, the original target. Challenges and future policy Specialised Mental Health Services 2007]. There is no doubt that both services and Within the municipalities as well, there has Trondheim: SINTEF Health, A7840, 2008. attitudes related to child and adolescent been a substantial increase in personnel. mental health problems have improved 5. Halsteinli V. Produktivitetsutviklingen i There are still, however, too few psychol- BUP poliklinikker 1998–2006: Betyrd- over the last ten years in Norway. The ogists, although measures to boost ningen av endret pasientsammensetning. national escalation plan has successfully recruitment are now in place. Moreover, [Productivity Growth in Child and increased capacity across the different the targeted increase in the number of Adolescent Mental Health Outpatient levels of mental health care, but barriers public health nurses has not yet been Clinics: The Impact of Case-mix and issues still exist. attained, although it is now within reach.6 Adjustment]. Trondheim: SINTEF Health, While improving the accessibility, quality Report A6587, 2008. Increased spending as a result of the esca- and the organisation of mental health 6. Kaspersen S, Ose SO, Hatlinig T. lation plan has been used, both for preven- services and treatment at all levels has been Psykisk helsearbeid i kommunene: tative measures and for treatment/ the focus of reform, it remains a major Disponering av statlig øremerkede midler follow-up, within the municipalities.7 The challenge, not only to develop smoother 1999–2007. [Mental Health Work in the objective has been to uncover non-optimal collaboration and cooperation between Municipalities: Disposition of Earmarked child development as early as possible, in primary health, social care (at the Funding]. Trondheim: SINTEF Health, order to implement curative and preven- municipal level) and specialised health Report A8811, 2008. tative measures at an early stage. services, but also to improve coordination 7. Norwegian Directorate of Health. Pilot programmes initiated at family assis- within existing primary health services. Status of Treatment Programmes, 2006. tance centres have been evaluated, Available at http://www.shdir.no/vp/multi- The government’s policy9 continues to providing examples of suitable tools for media/archive/00013/Mental_Health_in_ place a strong emphasis on preventative the coordination of municipal services Nor_13094a.pdf psycho-social work for children and directed at children, adolescents and their adolescents, in order to strengthen mental 8. Norwegian Directorate of Health. The families. Child health clinics, as well as health and identify needs as early as governmental strategy plan for children school health services, provide low possible. Access to specialist services and adolescents mental health (2003–2008). threshold services for pregnant women, should improve further through reduced Available at: http://www.regjeringen.no/ children, and adolescents as a core element upload/kilde/hod/red/2005/0011/ddd/pdfv waiting times for treatment. The of their services. An evaluation of these /233840-mentalhealthweb.pdf government also sees the necessity of low threshold services indicates that they increasing competence in the field of 9. Report to the Storting. The National represent an important supplement to mental health to address its broad multi- Budget. Oslo: Storting Paper 1 2008–2009. specialist mental health care. They do not sectoral impacts. An emphasis is thus put however, and are not intended to, replace on the provision of information and other assessment and treatment performed by measures, to both those of school and specialists. working age, in order to help improve atti- tudes towards people making use of Governmental strategic plan mental health services. In parallel with the escalation plan, a

27 Eurohealth Vol 15 No 1 SNAPSHOTS The introduction of long-term care insurance in South Korea

Soonman Kwon

Background passed in April 2007, but its implemen- being able to the ‘de-medicalise’ LTC. It is In July 2008, Korea introduced a new tation was delayed by a year, with the also easier for the government to persuade social insurance scheme for long-term care scheme finally coming into operation in the public to pay contributions which are (LTC). Several important demographic July 2008. LTC insurance had been exclusively for LTC. However, the sepa- and social changes have contributed to the proposed, and indeed was ultimately ration of LTC financing from health introduction of LTC insurance, including implemented, by a series of progressive insurance may be a barrier to coordination the rapid ageing of the population as a governments that strongly supported the between health and LTC if the two result of the increase in life expectancy and expansion of the welfare state.2 The different financing schemes try to offload the sharp decline in fertility which fell government’s reluctance to expand the their financial burdens on each other. below 1.1 in 2005.1 The proportion of public assistance programme for long-term older people (those over sixty-five) in care of (poor) older people has also Population coverage Korea was 9% in 2005, but is forecast to contributed to the rather early adoption of The new LTC insurance scheme provides increase at an unprecedented rate. Older a universal financing scheme based on coverage for all those over the age of sixty- people are expected to account for 16% of premium contributions. five, as well as age-related LTC needs for the population by 2020 and 38% by 2050, younger people. As a result, the Korean resulting in an old-age dependency ratio of Social Insurance for long-term care LTC insurance scheme does not provide 70%.1 Tax-based financing was never given coverage for disability-related care needs. serious consideration from the beginning The government has prioritised population With population ageing the demand for of discussions on a possible LTC financing ageing and related problems, rather than LTC has increased. Family structures have system. Contribution-based social aiming to solve problems related to LTC. also contributed; the proportion of older insurance financing was adopted because Thus the new LTC insurance, targeted to people living with adult children had the Korean welfare state is based on cover only aged-related care needs, will decreased to 38% by 2004. The availability various social insurance schemes such as have a limited effect on social solidarity. of informal or family caregivers is dimin- health insurance, pensions, unemployment ishing, given that female labour partici- In contrast to health insurance, individuals insurance, and workplace injury compen- pation is increasing and thus they are less need to obtain prior approval for services sation. By making use of the existing willing to provide care. Only 36% of those through an assessment of functional limi- administrative structure of the health who receive LTC also receive care from tations. In order to determine eligibility, a insurer, the National Health Insurance their spouse. However there are difficulties visit team from the local branch office of Corporation (NHIC), LTC insurance can in obtaining residential care because the the NHIC assesses the functional status of minimise administrative costs. supply of LTC facilities is limited and, individuals using a fifty-six item evalu- unlike health care which is covered by the Path dependency also affects the financing ation. There are three levels of functional health insurance programme, there had mix: LTC insurance in Korea is not a pure status/limitations, each with different been no similar system for LTC. social insurance, but financing from benefit levels. Local assessment contributions has a greater role than tax committees comprise no more than fifteen In response to these challenges, the subsidies. As in the case of health members, including a social worker and government established a Planning insurance, the Ministry of Health Welfare medical doctor (or traditional medical Committee for Long-Term Care for Older and the Family (MHWF) will play a key doctor). All decisions of the committee are People in 2000, and President Kim DJ role in the policy for LTC insurance and based on the assessment of ability to formally suggested the need to introduce tightly monitor the insurer. The NHIC, perform activities of daily living (ADL) LTC insurance in 2001. In 2003, President the single payer of health insurance, also undertaken by the visit team, alongside a Rho MH decided to launch a LTC strongly supports LTC insurance as an doctor’s report. insurance scheme in 2007. Legislation was opportunity to extend its own operation The difference in entitlements compared to and mitigate against the pressure of down- health care may not immediately be under- sizing/employment adjustment within its stood by older people. Initially there may Soonman Kwon is Professor of Health own organisation. Economics and Policy, School of Public be many appeals for reassessment of eligi- Health, Seoul National University, South LTC insurance, separate from health bility (functional status) as the LTC Korea. Email: [email protected] insurance, also has the potential benefit of scheme is rolled out. The current

Eurohealth Vol 15 No 1 28 SNAPSHOTS assessment scheme will reach about 3-4% lower than that for services. Cash benefits amounts to more than 30% of total health of the older population. This, however, can also mitigate some of the problems expenditure.5 The relative generosity appears to fall short of the demand for associated with the insufficient supply of between payments to long-term care long-term care, leading to criticisms that LTC service providers in Korea. hospitals (paid by health insurance) and the limited coverage threatens the univer- those to long-term care institutions (paid Delivery of long-term care salism of LTC insurance. The government by LTC insurance) will also affect provider does though have plans to increase popu- While the number of (private) providers in incentives. lation coverage incrementally, but progress the LTC sector has increased rapidly, lack LTC should also be closely coordinated in achieving this will depend on the of access to care providers still remains a with welfare services. At present however, financial sustainability of the LTC concern, with variation across localities a the role of local government is very limited insurance system. persistent problem. As of 2008, there were in the provision of LTC. It is only active in 1,530 LTC institutions with 64,671 beds, the area of financing for the long-term Level and type of benefits covering 1.28% of those aged 65 and over.4 needs of the poor (through the public Contributions to the LTC insurance are There are 8,011 home care providers, assistance programme) and the regulation determined as a fixed percentage (currently which are estimated to cover 2.2% of the and certification of LTC institutions. 4.05%) of the health insurance contri- older population. Entry of new providers Going forward LTC policy needs to bution, with the two contributions will depend on the generosity of compen- empower local governments, so as to help collected together. Overall, financing sation and fees set by the government. facilitate effective coordination between consists of a government subsidy of 20%, Quality of care is a critical issue. There is a LTC and welfare services. co-payment of 20% (institutional care) or broad spectrum in quality of care across 15% (home-based care), and an insurance LTC institutions. The government needs contribution of 60–65%. The poor are to monitor and disseminate information REFERENCES exempted from co-payments. Meals and on the quality of these providers. 1. Korean National Statistics Office. Popu- private rooms are not covered by LTC Payments to providers need to be differ- insurance. As LTC delivery in Korea is lation Statistics 2007. Daejeon: National entiated along structural lines (facility, Statistics Office, 2007 (in Korean). pre-dominantly private, one potential personnel) or service evaluation. The challenge is that private providers might training and working conditions of long- 2. Kwon S, Holliday I. The Korean welfare have perverse financial incentives to induce term care workers will also affect the state: A paradox of expansion in an era of globalization and economic crisis? Interna- demand for these additional areas of quality of LTC. service, resulting in an increased financial tional Journal of Social Welfare 2007; 16(3):242–48. burden on older people. Concluding remarks LTC insurance provides largely service The introduction of LTC insurance repre- 3. Kwon S. Future of long-term care benefits. Cash benefits are provided only sents a major change for social care in financing for the elderly in Korea. Journal of Aging and Social Policy in exceptional cases (for example, when no Korea. It will also have a significant impact 2008;20(1):19–136 providers are available in the region). on the health care system because older Benefits depend on the level of functional people account for a large share of health 4. Seok J-E. Choices and issues of long-term limitation determined in the assessment expenditure and admissions for social care care policy in Korea. Paper presented at process. There are ceilings on the benefits needs have been increasing. Coordination Annual Meeting of the Korean Geronto- for non-institutional care, ranging from between health insurance and LTC logical Society, Seoul, 20 November 2008. 1,097,000 Korean Won (about US$1,000) insurance will be a key to the continuum 5. Kwon S. Thirty years of national health per month for level one to just 760,000 of care and the prevention of unmet need. insurance in Korea: lessons for universal Korean Won per month for level three. Benefits provided through LTC insurance health care coverage. Health Policy and The type of payment to providers varies should be coordinated with those of health Planning (online prior to print publication) from pay per hour for home care, pay per insurance, where out-of-pocket payment 2008. visit for home nursing and baths, and pay per day for institutional care and International Conference on ‘Markets in European Health day/evening care. Systems: Opportunities, Challenges, and Limitations’ The limited role of cash benefits needs to be re-considered in Korea.3 A cash benefit system was not adopted because of the The European Observatory on Health Systems and Policies and the Ljubljana based potential for abuse and the low quality of Centre of Excellence in Finance (CEF) are organising an International Conference on care provided by informal care givers. The ‘Markets in European Health Systems: Opportunities, Challenges, and Limitations’. feminist movement, worried about the potential pressure on women to provide This conference, which will take place in Kranjska Gora, Slovenia from 16 to 17 June care in the case of cash benefits, did not 2009, will focus on how health systems’ financing can be reformed to ensure the most efficient resource allocation. It will address a number of questions concerning the influence the development of the system. extent to which the use of market mechanisms and competition are effective for better Nonetheless, cash benefits can have containing cost and improving health systems performance and how it relates to the positive effects on consumer choice and reality of health systems in the Central and Eastern European region. competition among formal and informal caregivers. Cost savings may also be More information on the event at http://www.cef-see.org/health/ possible when the level of cash benefits is

29 Eurohealth Vol 15 No 1 Evidence-based health care

Value of vision

These days it's all about cost. That's what many discover which patients would benefit from which people think about modern medicine. Others, and medicine we might do rather better for all of them. most health economists and purchasers would say, au While the argument rages, or mumbles on, we are contraire, it's all about value. The most expensive stuck with a definition of good value that works out, medicine, they would say, is the one that doesn't for a quality-adjusted year of life (QALY) of about work. Yet others, perhaps those giving this a little bit £30,000 or $50,000 or less. These are not easily calcu- more deep thought, would point out that no medicine lated, and lead into some very convoluted paths, as works in every patient, and perhaps if we could the example of age-related macular degeneration 1 Figure 1: Time-trade utility values for different levels of visual acuity (ARMD) demonstrates.

Visual value We measure vision most commonly by visual acuity, Visual acuity in better seeing eye a quantitative measure of the ability to identify black 20/20 symbols on a white background at a standardized 20/30 distance as the size of the symbols changes. Visual acuity is the smallest size that can be reliably iden- 20/40 tified. The well-known phrase '20-20 vision' refers to 20/50 the distance in feet that objects separated by an angle 20/100 of 1 arc minute (one sixtieth of one degree) can be 20/400 distinguished as separate objects. The metric equiv- 20/800 alent is 6-6 vision. Hand motions 20/20 means one can see small letters, 20/40 moderate No light perceptions letters only but not small ones, while 20/100 means 0.0 0.2 0.4 0.6 0.8 1.0 that only the very largest letters can be distinguished at 20 feet (6.096 metres), but that someone with Utility value normal vision would be able to distinguish these letters at a distance of 100 feet (30.48 metres). As the Table 1: Time-trade utility values given by patients and others for different levels of second number increases, then, visual acuity gets age-related macular degeneration severity worse. A review1 brings together some aspects of the way we Utility values value vision. For instance, Figure 1 shows the time ARMD severity Patients with Community Clinicians Ophthalmologists trade-off utility values for different levels of visual ARMD (n=82) (n=142) (n=62) (n=46) acuity, where a value of one is normal health and zero death. Here people are asked how many years of Mild remaining life they would trade for permanent (20/20 to 0.83 0.96 0.93 0.98 normal health. People with a moderate reduction in 20/40) acuity to 20/40 say they would be willing to trade Moderate four of 20 remaining years of life for a return to (20/50 to 0.68 0.92 0.88 0.89 normal visual acuity (1.0 minus {4/20}). 20/100) Severe Clearly, impaired vision impacts significantly on (20/200 or 0.47 0.86 0.82 0.73 health utility, but the degree by which vision is valued worse) is under appreciated by the public, clinicians in general, and ophthalmologists in particular (Table 1). Very severe 0.39 not available not available 0.67 Ophthalmologists, for instance, considered that (<20/800) patients would be prepared to lose 2% of available life years to return to 20/20 vision from 20/40, which Bandolier is an online journal about evidence-based healthcare, written by is what a utility value of 0.98 says in Table 1. By Oxford scientists. Articles can be accessed at www.jr2.ox.ac.uk/bandolier contrast, patients were prepared to lose 17% of their This paper was first published in 2007. © Bandolier, 2007. remaining time of life (utility = 0.83).

Eurohealth Vol 15 No 1 30 EVIDENCE-INFORMED DECISION MAKING

Table 2: Value gain in quality or length of life for interventions in age-related Comparison with other conditions macular degeneration and other conditions Visual acuity of <20/200 in the better eye (severe ARMD) has utility values similar to severe stroke, or advanced Intervention Value gain (%) prostate cancer with uncontrollable pain. Moderate ARMD (20/50 to 20/100) has similar utility values to moderate Interventions for macular degeneration stroke or a hip fracture. Mild ARMD has similar utility values to vertebral fractures or symptomatic HIV. Laser photocoagulation; subfoveal classic 4.4 When value gains are compared between some interventions for macular degeneration and interventions for other condi- Laser photocoagulation; extrafoveal classic 8.1 tions (Table 2), it is clear that they compare well in terms of quality or length of life. Photodynamic therapy 8.1 Comment Intravitreal pegaptanib 5.9 This particular paper1 is not one that Bandolier would normally consider for its pages. It is not a systematic review, Intravitreal ranibizumab > 15 and though it does look at quality of evidence, there are some deficiencies in the amount of evidence available. But it Interventions for other conditions does make one think, and for that reason alone is worth a quick read. For those engaged in the difficult decisions Bisphosphonates for osteoporosis 1.1 around value and cost for different interventions, it is probably worth a more detailed read, especially with some Alpha-blockers for BPH 1–2 effective but perhaps costly therapies coming our way.

Statins for hyperlipidaemia 3.9

REFERENCE Beta-blockers for hypertension 6–9 1. Brown MM, Brown GC, Brown H. Value-based medicine PPI for reflux 11 and interventions for macular degeneration. Current Opinion in Ophthalmology 2007;18(3):194–200.

Investing in hospitals of the future

Edited by: Bernd Rechel, Stephen Wright, Nigel Edwards, Barrie Dowdeswell and Martin McKee

Despite considerable investments in health facilities worldwide, little systematic evidence is available on how to plan, design and build new facilities that maximise health gain and ensure that services are responsive to the legitimate expectations of users. This book brings together current knowledge about key dimensions of capital investment in the health sector. A number of issues are examined, including new models of long-term care, capacity planning, the impact of capital investment on the health care workforce, markets and competition, systems used for procurement and financing, the whole lifecycle of health facilities, facility management, the wider impact of capital investment on the local community and economy, how care models can be translated into capital asset solutions, and issues of therapeutic and World Health Organization sustainable design. 2009, on behalf of the European Observatory on This book is of value to those interested in the planning, financing, construction, and Health Systems and Policies management of new health facilities. It identifies critical lessons that increase the chances that capital projects will be successful. Observatory Studies Series No. 16, 284 pages ISBN 978 92 890 4304 5 Available for download at: http://www.euro.who.int/Document/E92354.pdf

31 Eurohealth Vol 15 No 1 Risk in Perspective

AN OVERVIEW OF “SCIENCE AND DECISIONS: ADVANCING RISK ASSESSMENT”

Jonathan Levy Introduction for improving the risk analysis approaches While risk assessment has existed in various used by the EPA. The “Committee on forms for many years, the process used by Improving Risk Analysis Approaches Used the United States Environmental Protection by the US EPA,” on which I served, was Agency (EPA) and others was formalised in charged to focus on human health risk the pivotal 1983 National Research Council analysis and to consider all environmental (NRC) report known as the Red Book.1 media (water, air, food, and soil) and all “Risk assessment should The Red Book codified the well-known routes of exposure (ingestion, inhalation, four steps of risk assessment (hazard iden- and dermal absorption). The committee was be viewed as a method for tification, exposure assessment, dose- asked to consider practical improvements evaluating the relative response assessment, and risk that could be made in the near term (the merits of various options characterisation) and emphasised the next two to five years) and over a longer necessity of a conceptual distinction term (ten to twenty years). The committee 2 for managing risk, not as between risk assessment and risk released its final report in December 2008. an end in itself” management. Over the intervening quarter- This issue of Risk in Perspective provides a century, risk assessment has evolved brief overview of the key conclusions of the substantially, driven in part by additional report. The text and figures below are NRC reports, EPA and other agency guide- largely based on the report. lines, and publications in the peer-reviewed literature. Framework of the Committee’s evaluation The committee determined that risk However, concerns about the value and assessment could be improved either by relevance of risk assessment for making improving the technical analyses (by incor- policy decisions have grown over time, porating improvements in scientific especially as risk-management issues that knowledge and techniques) or by appear difficult to address with standard improving the utility of risk assessment for risk assessment methods (such as global decision-making. The latter can be achieved climate change, endocrine disruption, in several ways, including improving the nanotechnology, and environmental justice) ways in which risks are characterised and have come to the fore. Risk assessments for uncertainties expressed and ensuring that This article is reproduced with some chemicals have taken decades to risk assessments are constructed in a permission and was first published as complete, in part because the presence of manner that is maximally informative for Risk in Perspective Volume 17, Number 1 uncertainty has contributed to decision- decision-makers. by the Harvard Center for Risk Analysis making gridlock. At the same time, the As a general principle, the committee in February 2009. underlying science has changed substan- recommended that risk assessment should tially in recent years, with advancements in be viewed as a method for evaluating the Peer reviewer: Greg Paoli, Risk Sciences genomics, analytical methods to measure relative merits of various options for International, Ottawa and member of the biomarkers, and computational capacity for managing risk, not as an end in itself. This NRC Committee on Improving Risk exposure models. In addition, there have has a number of implications for the Analysis Approaches Used by the U.S. been major changes in the expectations of practice of risk assessment. It implies a EPA. the public and interest groups with respect greater need for upfront planning of the to consultation and public participation, risk assessment, in which considerable Harvard Center for Risk Analysis, and risk assessments are increasingly inte- discussion among risk managers, risk Harvard School of Public Health, grated with other decision-making inputs assessors, and other stakeholders helps to Landmark Center, 401 Park Drive, such as regulatory cost assessments. PO Box 15677, Boston, determine the risk-management questions Massachusetts, 02215 USA. Against this backdrop, the EPA asked the that risk assessment should address. It also The full series is available at NRC to form a committee to develop implies that the technical analyses within www.hcra.harvard.edu scientific and technical recommendations the risk assessment should be more closely

Eurohealth Vol 15 No 1 32 EVIDENCE-INFORMED DECISION MAKING aligned with the questions to be answered. assessment design options (for example, determines that the alternative is ‘clearly For example, the level of detail of uncer- consultative processes, peer engagement superior’ (that its plausibility clearly tainty and variability analyses should align and review processes, means to improve exceeds the plausibility of the default), with what is needed to inform risk- transparency, methods for analysing while EPA should report additional risk management decisions, rather than being uncertainty) considered from the estimates corresponding to alternative defined as a task limited only by computa- perspective of their ultimate impact on the assumptions within the risk characteri- tional capacity. The committee’s conclu- overall quality of the agency’s decision- sation whenever the alternative assump- sions were therefore organised around making processes. tions are of ‘comparable plausibility’. measures to improve either the utility or Applying these criteria allows EPA to the technical content of risk assessment, Uncertainty and variability balance the need for comprehensive uncer- within a decision-oriented framework. Characterisation of uncertainty and vari- tainty characterisation with the need for ability cuts across all elements of a risk timely and consistent decision-making. Design of risk assessment assessment and many of the topics in the The committee also emphasised that there The committee encouraged EPA to focus committee’s statement of task. As a general are many implicit or missing defaults greater attention on design in the formative principle, the committee concluded that within current risk assessment practice, stages of risk assessment, including EPA needs to characterise and commu- such as the assumption that an untested planning, scoping and problem formu- nicate uncertainty and variability in all key chemical has no risk and the assumption lation, similar to the approaches articulated computational steps of a risk assessment that all humans (at the same life-stage) are in EPA guidance for ecological risk and noted that many risk assessments equally susceptible to carcinogens. The assessment and cumulative risk assessment. implicitly or explicitly omit multiple areas committee concluded that EPA should With risk assessment considered as a of uncertainty or variability. For example, develop explicitly-stated defaults to take decision-support product, it should be emissions estimates are often treated as the place of the implicit defaults. designed as the best solution to achieving known and variability in cancer suscepti- multiple simultaneous and competing bility is often ignored or isolated to A unified approach to dose-response objectives while satisfying constraints on defined subpopulations. That being said, assessment the process or the end product. For the committee also emphasised that the Historically, dose-response assessments example, while use of the best scientific level of detail with which uncertainty and have been conducted differently for cancer evidence and methods is a clear design variability are characterised should depend and non-cancer effects. For cancer, it has objective, this may compete with objec- on the extent to which detail is needed to generally been assumed that there is no tives to be more expansive in scope, to inform specific risk-management decisions dose threshold of effect and dose-response provide timely outputs, and to have trans- and recommended that EPA adopt a assessments have focused on quantifying parency in process. “tiered” strategy for selecting the level of risk at low doses (although consideration One dimension of interest to the detail within the planning stage of the risk of mode of action has led to some recent committee and EPA was the application of assessment. exceptions). For most non-cancer effects a value-of-information (VOI) principles, dose threshold has been assumed, below which can be key components of the iter- Selection and use of defaults which effects are not expected to occur or ative design of risk assessments. When risk One of the more vexing challenges are extremely unlikely. This dose is assessments are used within a decision- involves the use of defaults within assess- referred to as a reference dose (RfD), with making environment, there is a need to ments and the decision to apply substance- an analogous definition for a reference determine whether information is specific data or default values. In the Red concentration (RfC). adequate to make a decision or if more Book, it was recognised that there was a There are both scientific and operational research is required. VOI analysis can help need for uniform inference guidelines (or limitations with these current approaches. determine when investments in further defaults) that would specify the assump- Non-cancer effects do not necessarily have information gathering are worthwhile. tions to be used generally within risk a threshold or low-dose nonlinearity. However, the committee concluded that assessments in order to ensure consistency Background exposures and underlying formal quantitative VOI analysis may only and avoid manipulation of assessment disease processes contribute to population be possible or desirable for a small number outcomes. While such guidelines are background risk and can lead to a non- of decisions, in which decision rules are necessary for decision-making, the appro- threshold response when considered at the clear, estimates of uncertainty are compre- priateness of the use of a default in the face population level. In addition, because the hensive, and the stakes of the decision are of data and theory that may support an RfD does not quantify risk at different high enough to warrant the effort. The alternative plausible assumption has been levels of exposure but rather provides a committee offered two alternatives to debated extensively, often leading to bright line between possible harm and formal quantitative VOI methods. The protracted delays. The committee possible safety, its use in risk-management first alternative is to maintain the logic of concluded that established defaults need to decision-making is both limited and prone the formal method by describing and eval- be maintained for the steps in risk assess- to misinterpretation. For cancer risk, the uating, though in a qualitative manner, the ments that require such inferences, and mode of action of carcinogens varies and impact of specific potential reductions in that clear criteria should be made available assessments usually do not account for uncertainty on the choices facing the for judging whether, in specific cases, data differences among humans in cancer decision-maker. The second alternative is are adequate to support an inference in susceptibility other than possible differ- to apply an analogous ‘value-of-methods’ place of a default. The committee proposed ences in early-life susceptibility. approach to characterise the potential that EPA should adopt an alternative benefits of the many choices among risk assumption in place of a default when it The committee concluded that both scien-

33 Eurohealth Vol 15 No 1 EVIDENCE-INFORMED DECISION MAKING tific and risk-management considerations Figure 1. New unified process for selecting approach and methods for dose-response assessment support unification of cancer and non- for cancer and non-cancer endpoints involves evaluation of background exposure and population cancer dose-response approaches. This vulnerability to ascertain potential for linearity in dose-response relationship at low doses and to unification can occur within a framework ascertain vulnerable populations for possible assessment that includes formal systematic assessment of background disease patterns and expo- sures, possible vulnerable populations, and Assemble health effects data modes of action (MOA) that may affect a chemical’s dose-response relationship in humans (Figure 1). This approach rede- fines the RfD as a risk-specific dose that provides information on the percentage of the population that can be expected to be Endpoint assessment above or below a defined acceptable risk • Identify adverse effects, focusing on those of concern for exposed populations with a specific degree of confidence. The • Identify precursors and other upstream indicators of toxicity redefined RfD can still be used as the conventional RfD has been to aid risk- • Identify gaps – for example, endpoints or lifestages under assessed or not assessed management decisions, but it provides additional information that allows for the inclusion of non-cancer endpoints in risk- risk and risk-benefit comparisons. The new definition also decreases the potential MOA assessment Vulnerable populations Background exposure for misinterpretation when the value is (for each endpoint of assessment assessment understood as an absolute indicator of a concern) level of safety. Identify potentially • Identify possible back- • Research MOAs for vulnerable groups and ground exogenous Other characteristics of the committee’s endpoints observed in individuals, considering and endogenous recommended unified dose-response animals and humans endpoints, the potential exposures approach include use of a spectrum of data MOA, background rate • Evaluate the suffi- • Conduct screening from human, animal, mechanistic, and of health effect, and ciency of the MOA level exposures and other relevant studies; a probabilistic char- other risk factors evidence analysis focusing on acterisation of risk; explicit consideration high end exposure of human heterogeneity (including age, • Evaluate endogenous processes contributing groups sex, and health status) for both cancer and to MOA non-cancer endpoints; characterisation

(through distributions to the extent } possible) of the most important uncer- tainties for both cancer and non-cancer endpoints; use of probabilistic distribu- tions instead of uncertainty factors when Conceptual model selection possible; and characterisation of sensitive Develop or select conceptual model: populations. • From linear conceptual models unless data sufficient to reject low dose linearity Cumulative risk assessment • From non-linear conceptual models otherwise EPA is increasingly asked to address broader public health questions that extend beyond individual chemicals to consider multiple exposures, complex mixtures, and vulnerable populations in a community setting. In response, EPA has Dose response method selection developed cumulative risk assessment, defined as an evaluation of the combined Select dose response model and method based on: risks posed by all routes, pathways, and • Conceptual model sources of exposure to multiple agents or Dose-response modeling stressors. The committee applauded EPA’s • Data availability and results reporting move toward this broader definition to • Risk management needs for form of risk make risk assessment more informative characterisation and relevant to decisions and stakeholders, but felt that EPA cumulative risk assess- ments fall short of what is possible and supported by agency guidelines. In Reprinted with permission from Science and Decisions: Advancing Risk Assessment ©2008 particular, there has been little consider- by the National Academy of Sciences, Courtesy of the National Academies Press, ation of non-chemical stressors, vulnera- Washington, D.C.

Eurohealth Vol 15 No 1 34 EVIDENCE-INFORMED DECISION MAKING

Figure 2. A framework for risk-based decision-making that maximises the utility of risk assessment

PHASE I: PHASE II: PHASE III:

PROBLEM PLANNING AND CONDUCT OF RISK ASSESSMENT RISK MANAGEMENT FORMULATION AND SCOPING Stage 1: Planning For the given decision-context, what are the attributes of assessments necessary to characterise risks of existing conditions and the effects on risk of proposed options? What level of uncertainty and variability analysis is appropriate? What are the relative health or environmental Stage 2: Risk assessment What problem(s) are benefits of the proposed associated with • Hazard identification options? existing environ- What adverse health or environmental effects are How are other decision- mental conditions? • Risk characterisation associated with the agents of concern? making factors (tech- If existing conditions What is the nature and nologies, costs) affected • Dose-response assessment appear to pose a magnitude of risk by the proposed threat to human or For each determining adverse effect, what is the associated with options? environmental health, relationship between dose and the probability of existing conditions? what options exist for the occurrence of the adverse effects in the range What is the decision, What risk decreases altering those condi- of doses identified in the exposure assessment? and its justification, in tions? (benefits) are light of benefits, costs, associated with each and uncertainties in Under the given of the options? each? decision context, • Exposure assessment what risk and other Are any risks How should the decision What exposures/doses are incurred by each technical assessments increased? What are be communicated? population of interest under existing conditions? the significant are necessary to Is it necessary to How does each option affect existing conditions uncertainties? evaluate the possible evaluate the effec- and resulting exposures/doses? risk management tiveness of the decision? options? If so, how should this be Stage 3: Confirmation of utility done? Does the assessment have the attributes called for in planning? NO YES Does the assessment provide sufficient information to discriminate among risk management options?

Has the assessment been satisfactorily peer reviewed?

FORMAL PROVISIONS FOR INTERNAL AND EXTERNAL STAKEHOLDER INVOLVEMENT AT ALL STAGES

The involvement of decision-makers, technical specialists, and other stakeholders in all phases of the processes leading to decisions should in no way compromise the technical assessment of risk, which is carried out under its own standards and guidelines.

Reprinted with permission from Science and Decisions: Advancing Risk Assessment © 2008 by the National Academy of Sciences, Courtesy of the National Academies Press, Washington, D.C. bility, and background risk factors. The The committee also concluded that there risks are considered, the committee committee concluded that conducting was a need for simpler analytical tools that proposed a framework for risk-based cumulative risk assessments within a risk- could allow for screening-level cumulative decision-making (Figure 2). The management context would allow for a risk assessments and that databases and framework consists of three phases: I) more streamlined assessment, focusing on default approaches should be developed enhanced problem formulation and only those stressors that contribute to for non-chemical stressors in the absence scoping, in which the available risk- endpoints of interest for risk-management of population-specific data. management options are identified; II) options and that are either differentially planning and assessment, in which risk- affected by different control strategies or Improving the utility of risk assessment assessment tools are used to determine influence the effects of stressors that are Given the desire for risk assessments that risks under existing conditions and under differentially affected. Insights from fields are relevant to the problems and decisions potential risk-management options; and such as ecological risk assessment and at hand, and the corresponding need for III) risk management, in which risk and social epidemiology, that have confronted assessments to be designed to ensure that non-risk information is integrated to similar complexities, should be leveraged. the best available options for managing inform choices among options.

35 Eurohealth Vol 15 No 1 EVIDENCE-INFORMED DECISION MAKING

The framework has at its core the risk Administration and new Congress are in context. This framework may be particu- assessment paradigm established in the place, early senior-level leadership larly helpful in settings where analytical Red Book, but differs from the Red Book attention to several issues will be critical, and computational resources are limited, paradigm primarily in its initial and final including developing explicit policies that as it emphasises that the most computa- steps. The framework begins with a ‘signal’ commit EPA to the revised framework, tionally complex model is not always the of potential harm (for example, a positive addressing funding levels, and adopting a most appropriate. Turning to the technical bioassay or epidemiologic study, a suspi- set of evaluation factors for assessing the content, the proposed unification of cancer cious disease cluster, findings of industrial outcomes of policy decisions and the and non-cancer dose-response approaches contamination). It focuses upfront on the efficacy of the framework. would be expected to have far reaching options that are available to reduce the impacts, potentially elevating the impor- Because of the high financial and political hazards or exposures that have been iden- tance of non-cancer endpoints in risk- stakes of risk-management decisions, there tified and on the structure of the risk management decisions in many settings. is unprecedented pressure on risk assessors assessments needed to evaluate the merits Coupled with the revised approach toward and decision-makers at EPA. However, the of the options being considered (that will defaults and cumulative risk assessment, committee felt that risk assessment remains generally include ‘no intervention’ as an the committee’s technical recommenda- essential to the agency’s mission. The goal option). The framework also calls for tions should also stimulate new primary of the committee’s recommendations was formal stakeholder involvement research that will enhance the scientific to provide a template for the future of risk throughout the process, with time limits to basis for risk assessment. assessment at EPA, strengthening the ensure that decision-making schedules are scientific basis, credibility, and effec- met and with incentives to allow for tiveness of future risk-management deci- balanced participation of stakeholders, REFERENCES sions. including impacted communities and less 1. National Research Council. Risk advantaged stakeholders. Although the committee’s statement of Assessment in the Federal Government: task and report focused on practices at Managing the Process. Washington, D.C: Additional dimensions and conclusions EPA, many aspects of the committee’s National Academy Press, 1983. The committee’s recommendations call for recommendations should be relevant to 2. National Research Council. Science and considerable modification of EPA’s risk other agencies and applications. While Decisions: Advancing Risk Assessment. assessment efforts. Improving risk NRC committees have previously Washington, D.C: National Academy assessment practice and implementing the cautioned that risk assessment differs Press, 2008. Available at www.nap.edu/ framework for risk-based decision-making greatly across federal agencies and should catalog.php?record_id=12209 will require a long-term plan and not be approached identically,4 the general 3. Hegstad M. EPA prepares to implement commitment to build the requisite capacity concept of designing a risk assessment to NAS advice to improve risk studies. Inside within EPA. EPA’s current institutional be aligned with risk-management needs EPA 2008;29(51), 19 December. structure and resources may pose a chal- should be broadly applicable. The lenge to implementation of the recommen- framework for risk-based decision-making 4. National Research Council. Scientific dations and moving forward with them would also apply in many settings, espe- Review of the Proposed Risk Assessment Bulletin from the Office of Management will require a commitment to leadership, cially given its emphasis on conducting and Budget. Washington, D.C: National cross-program coordination and commu- assessments with appropriate scope and Academy Press, 2007. nication, and training. That will be possible level of complexity for the decision only if leaders are determined to reverse the downward trends in budgeting, staffing, and training and to making high- quality risk-based decision-making an Health Economics, Policy and Law agency-wide goal. The committee International trends high HEPL invites high quality contributions therefore recommended that EPA should light the confluence of in health economics, political science initiate a senior-level strategic re-exami- economics, politics and legal and/or law, within its general aims and nation of its risk-related structures and considerations in the health scope. Articles on social care issues processes to ensure that it has the institu- policy process. HEPL serves are also considered.The recom tional capacity to implement the as a forum for scholarship mended text length of articles is committee’s recommendations. The on health policy issues from these perspectives, 6 8,000 words for original research committee further recommended that EPA and is of use to academics, policy makers and articles, 2,000 words for guest edito should develop a capacity-building plan health care managers and professionals. rials, 5,000 words for review articles, and 3,000 words for debate essays. that includes budget estimates required for HEPL is international in scope, and publishes implementing the committee’s recommen- both theoretical and applied work. Considerable Instructions for contributors can be http://assets.cambridge.org/ dations. emphasis is placed on rigorous conceptual found at HEP/HEP_ifc.pdf development and analysis, and on the presen EPA is already taking steps to implement tation of empirical evidence that is relevant to All contributions and correspondence some of the key recommendations from the policy process.The most important output this report,3 with staff preparing to meet should be sent to: Azusa Sato, of HEPL are original research articles, although Assistant Editor, LSE Health, London and consider recommendations such as readers are also encouraged to propose School of Economics and Political ways to harmonise cancer and non-cancer subjects for editorials, review articles and Science, Houghton Street, London risk approaches and to increase the utility debate essays. WC2A 2AE, UK. Email [email protected] of assessments. Now that the Obama

Eurohealth Vol 15 No 1 36 NEW PUBLICATIONS

Eurohealth aims to provide information on new publications that may be of interest to readers. Contact Azusa Sato at [email protected] if you wish to submit a publication for potential inclusion in a future issue.

Across the Pond – Lessons from the This report investigates integrated care in this approach calls for stronger US on Integrated Healthcare the United States and suggests lessons for management. Finally, integration between the English health system. It is argued that services, care and structures will support although the English National Health more fluid information flows between key Richard Gleave Service’s (NHS) single-payer system seems actors. to be the ultimate integrated health care Gleaves takes a holistic approach, using system, at a local level, NHS organisations evidence from medium-sized and smaller have often struggled to deliver integrated integrated models. Four integrated system care. Three cross-cutting themes are iden- case studies are used: Kaiser Permanente tified: integrated governance; risk Colorado; Geisinger System Pennsylvania; management and use of incentives; and inte- Kaiser Permanente North West; and Health grated health information technology. Partners Minnesota. The report concludes On integrated governance, Gleave argues that the spirit of innovation is lacking in the that American systems are founded upon English NHS, compared to the US where London: Nuffield Trust, 2009 strong leadership and management which integrated care systems are built upon dedi- ISBN-13: 978-1-905030-35-4 deliver locally sensitive and practical gover- cated and well managed physician and nance structures. Additionally, structures administrative leaders. 39 pages must be juxtaposed with a culture that Contents: Foreword; Executive Summary; Freely available online at: prompts integrated care delivery as well as Introduction; Divided by a Common http://www.nuffieldtrust.org.uk/ accountability. With regards to risk Language – integration in the UK and US; publications/detail.aspx?id=0&PRid=554 management, integrated payer systems Integrated Governance; Risks and Incen- should harness sophisticated risk tives; IT and Integration; Policy Implica- adjustment methodologies in order to align tions for the NHS; Conclusion; Glossary; incentives within a single organisation or Appendix and References between health plans and providers. Again,

The Swiss and Dutch Health This report from the Commonwealth Fund patient cost-sharing to influence care- Insurance Systems: Universal evaluates systems that combine universal seeking behaviour. For example, Dutch Coverage and Regulated Competitive coverage with private insurance and regu- health insurance companies are allowed to Insurance Markets lated market competition. The authors make a profit whilst Swiss insurers must be contrast the systems of Switzerland and the non-profit; similarly, collective insurance Netherlands in light of the health reforms contracts are outlawed in Switzerland Robert Leu, Frans Rutten, Werner undertaken by the State of Massachusetts whilst up to 57% of enrolees are insured Brouwer, Pius Matter and Christian and considered by other federal states. through this mechanism in the Netherlands. Rütschi It is found that the two systems have many The Swiss and Dutch health models provide features in common: an individual mandate, blueprints for feasible co-existing private- standardised basic benefits, a tightly regu- public systems in the US, and the working lated insurance market, and funding paper urges policymakers to take this into schemes that make coverage affordable for account especially in light of increasing low- and middle-income families. For demand for universal coverage for example, in both countries uninsured rates American citizens. are under 1.5% with a wide range of Contents: Foreword; Introduction; System benefits offered. Furthermore, insurers are Overview; Enforcement of Mandatory regulated to guarantee acceptance of all Health Insurance; Basic Benefit Package; applicants, a scheme encouraged through Cost-sharing by Patients; Market for Basic the use of risk equalisation which redis- 40 pages Health Insurance; Premium Differences; tributes funds on the basis of measures of Mobility of Consumers; Risk Equalisation; Freely available at: http://www.common population need. wealthfund.org/Content/Publications/Fu Managed Care Plans, Gatekeeping and nd-Reports/2009/Jan/The-Swiss-and- Differences between the Netherlands and Selective Contracting; Conclusion; Dutch-Health-Insurance-Systems-- Switzerland include the degree of centrali- Appendix; References Universal-Coverage-and-Regulated-Com sation, basis of competition among insurers, petitive-Insurance.aspx availability of managed care and reliance on

37 Eurohealth Vol 15 No 1 Please contact Azusa Sato at [email protected] to suggest web sites for WEBwatch potential inclusion in future issues.

DG Information Society and This European Commission website looks at the role of Information and Communication Technologies Media, ICT for Health (ICT) in the field of health. It provides information on current and previous research projects, research opportunities, news, events and links to conferences related to eHealth. A library provides further http://ec.europa.eu/information resources with newsletters and videos available for free download under the ‘information centre’ tab. _society/activities/health/index_ The web site is hosted in German, English, Spanish, French, Italian and Polish. en.htm

European Health Telematics EHTEL was founded in 1999 to provide a pan European multi-stakeholder forum for European insti- Association tutions, policymakers and corporations for the betterment of health care delivery through eHealth. The homepage hosts a variety of resources for upcoming events and conferences, links to other sites, policy http://www.ehtel.org/ papers freely available for download and press releases. A forum provides users with further infor- mation to stakeholder groups and announcements.

European Patients’ Smart EPSOS is a thirty-six month European eHealth project which aims to enable secure access to patient Open Services (EPSOS) health information between European health care systems. The web site provides details of the initiative, including a work plan and information examples include patient summaries for cross-border http://www.epsos.eu/ communication and ePrescriptions. Past and future events are advertised and a press area provides major news articles and progress reports on the project. In a download area, users are able to browse and print a variety of policy papers.

The International Council The ICMCC is an international foundation, making information on medicine and care available to on Medical and Care patients and professionals using compunetics. Compunetics is shorthand for COMPUting and Compunetics Networking, EThICs and Social/societal implications. The main homepage lists events, conferences and news headlines. A patient record access link deals with aspects of accessibility and portability of http://www.icmcc.org/ electronic health records for patients, carers and service providers. It outlines the rationale, benefits, current research and overviews on six countries using the system (UK, USA, The Netherlands, Estonia, Canada, Australia). An online poll and contact form encourages user feedback, and the community section, including a blog, welcomes interaction and further exchange.

Telecare LIN Telecare LIN is an English national network supporting local service redesign through the application of telecare and telehealth to aid the delivery of housing, health, social care and support services for http://networks.csip.org.uk/ older and vulnerable people. Advice on telecare use, services and outcomes are contained in free IndependentLivingChoices/ monthly newsletters, reports and factsheets. Telecare/

Telecare Services The TSA is a representative body for the telecare industry within the UK, its mission being ‘to unlock Association (TSA) the potential of telecare and telehealth’. The homepage distinguishes between professional users/suppliers and service users/carers, providing a separate portal for each. For both users, the web http://www.telecare.org.uk/ site explains what telecare is, how it works and who can benefit from it, with examples of available products and case studies presented. For professional users, a section on current affairs and policy gives further links to articles which have appeared in the news, government guidance on telecare, publi- cations and speeches, all of which are available for download. Additional links detail past and forth- coming events related to telecare, as well as a ‘find a service’ facility whereby consumers and service providers alike can search for services around Great Britain.

Eurohealth Vol 15 No 1 38 MONITOR

NEWS FROM THE ities, as well as their preparedness 400,000 more children will die INSTITUTIONS and response to emergencies. For every year – between 1.4 and 2.8 instance, in earthquake-prone million children before 2015. countries such as Japan, Pakistan Any reduction in investment in World Health Day: making and Peru, hospitals have been health care will have devastating hospitals safe in emergencies built using efficient building consequences for the sick and The World Health Organization standards that require little addi- untreated, and has the potential (WHO) celebrated World Health tional costs but can withstand to plunge new groups and Day 2009 on 7 April by focusing earthquakes. nations into poverty. attention on the large number of WHO is urging all ministries of Moreover, greater numbers of lives that could be saved during health to review the safety of mothers and children will die of earthquakes, floods, conflicts and existing health facilities and to preventable diseases this year other emergencies through better ensure that any new facilities are than in 2008. as the financial crisis design and construction of health built with safety in mind. Prac- derails improvements that poorer facilities and by preparing and tical and effective low-cost countries are making in their training health staff. It was measures such as protecting health care systems. Unless launched in Beijing, less than a equipment, developing emer- donors and developing countries year after the major earthquake gency preparedness plans and meet international targets for near Chengdu City killed over training staff can help make increasing support to health, the 87,000 people and destroyed health facilities safer, better funding gap will be an estimated more than 11,000 health care prepared and more functional in $30 billion a year by 2015. This facilities. emergencies money is needed to make rapid progress towards strengthening WHO is recommending six core More information on World health systems in the world’s actions that governments, public Health Day 2009 is available at poorest countries and ensuring health authorities and hospital http://www.who.int/world- basic health care services are managers can undertake to make health-day/2009/en/index.html their health facilities safe during made available to all – the poor as well as the better off. Unless emergencies. These include High Level Task Force on more resources are found, the adopting national policies and Innovative Financing for Health health-related Millennium programmes for safe hospitals, meets in London Development Goals (MDGs) to training health workers, On 13 March 2009 world leaders cut child mortality rates, improve designing and building safe convened in London for the maternal care and combat HIV hospitals, retrofitting existing second meeting of the Taskforce AIDS and malaria, will not be health facilities to make them on Innovative International met. more resilient and ensuring staff Financing, co-chaired by UK

News and supplies are secure. Prime Minister Gordon Brown This warning came in an Inde- “With our world threatened by and World Bank President, pendent Working Group report the harmful effects of climate Robert Zoellick. Launched in to the Taskforce. It also stresses change, more frequent extreme New York in September 2008, that even if poorer countries weather events and armed the Taskforce is focused on themselves and aid donors meet conflicts, it is crucial that we all strengthening health systems in existing commitments, including do more to ensure that health the poorest countries in the all donors achieving 0.7% of care is available at all times to our world. Brown and Zoellick are gross national income for citizens, before, during, or after a joined on the Taskforce by world overseas development aid and developing country governments disaster,” said WHO Director- leaders from Australia, Ethiopia, France, Germany, Italy, Liberia, investing 15% expenditure in General Dr Margaret Chan. Mozambique and Norway, as health care, there will still be a Too often, health facilities are the well as WHO and the UN. The funding gap of $7 billion a year. first casualties of emergencies. group is reviewing a number of At the moment, low-income This means that health workers options to raise and use addi- countries spend $24 per capita on are killed and wounded, that tional money for health care. health care. This compares to the services are not available to treat Two independent Working $4,000 per capita that rich coun- survivors and that large invest- Groups have been established to tries typically spend on health ments of valuable health funding advise the Taskforce on the Press releases and care. While better health care in health facility construction and constraints and costs of the other suggested systems have led to a fall in equipment are squandered. Yet funding gap and the mechanisms information for HIV/AIDS infections and wider relatively inexpensive invest- for raising and channelling the future inclusion availability of malaria bed nets ments in infrastructure can save funds. can be emailed to and tuberculosis (TB) treatment, lives during disasters. the editor The World Bank estimates that, if there is an urgent need to invest David McDaid Some countries have taken action the current economic crisis more in the fabric of developing [email protected] to improve safety of health facil- persists, between 200,000 and country health systems; espe-

39 Eurohealth Vol 15 No 1 MONITOR cially training and employing more health expenditure and greater mobility. Patients same access as residents to necessary workers. will be able to obtain information about health care when visiting another EU their health or drug dosage while their country. Spain is the one of the top tourist The Taskforce also discussed a companion personal data will be fully protected”, said destinations in Europe, but the current report containing initial proposals for Czech Minister of Health Daniela Fili- Spanish rules impose additional red tape new ways of financing health care to meet piová. on EU pensioners who might need access the gap. The report reviews a number of to medication during a temporary stay. innovative options to raise and use addi- At the end of the conference the Prague We’re taking action today to make sure tional money more effectively. It high- Declaration was adopted. Its main holidaymakers from other EU countries lights the case for frontloading objective was to sum up the current state enjoy the same rights as residents.” expenditure, solidarity levies on airline of the Europe-wide effort to use infor- tickets, using market mechanisms to stim- mation and communication technologies Under Article 31 of Regulation (EEC) No ulate health investments, and encouraging in health care for the benefit of patients, 1408/71 of the Council of 14 June 1971 on greater contributions from the public and as well as for improved economic effi- the application of social security schemes the private sector. Further, it sets out that ciency in the health sector. It also aims to to employed persons and their families international external and domestic determine further steps to be taken at moving within the Community, financing must increase simultaneously member state level, as well as by pensioners are entitled to receive and be managed cohesively. The Working European institutions. At the same time, a necessary health care during a temporary Group will report its findings to the Task- common European eHealth area should stay in another member state. force in May and the Taskforce will be built, where individual national The European Health Insurance Card publish its recommendations before the systems will be able to communicate with (EHIC) facilitates access to necessary care G8 Summit in Italy. one another. Integrating eHealth solu- when the holder falls ill or has an accident tions into the national health strategies of More information including speeches in in one of the participating countries. It the EU member states will also be of great London and reports from the two inde- can be used on any temporary stay importance. pendent working groups are available at abroad, be it for holidays, work or http://www.internationalhealthpartner Delegates also agreed that actions of studies. Over 170 million Europeans now ship.net/taskforce_working_groups.html member states directed towards eHealth hold an EHIC, which is valid in 31 implementation and their mutual high- European countries (EU + Switzerland, European Conference of Health level coordination should become a Norway, Iceland and Liechtenstein). Ministers and Prague Declaration regular part of the agenda of each Presi- Spanish legislation allows pensioners A ministerial conference entitled dency. Chair of the meeting, Marek insured in Spain to get medication for “eHealth for Individuals, Society and Šnajdr, Czech First Deputy Minister of free. But EU pensioners are required to Economy” organised by the Ministry of Health said that he was very pleased that show an additional document issued by Health as one of its priority events during the Czech Presidency had brought their national social security services, in the Czech Presidency of the Council of together high level ministers to discuss Spanish, to certify that they are in receipt the EU, took place in Prague on the 19- this issue for the first time. He noted that of a state pension. The Commission 20th of February. This is already the their agreement on the importance of the believes this is contrary to European seventh conference in a series of eHealth issue “is a breakthrough as it aims at provisions and discriminates against EU conferences and, traditionally, is attended establishing a high-level coordination pensioners on holiday in Spain. Moreover, not only by representatives of the EU structure which should deal with issues the requirement to present a supple- member states, but also the candidate such as data compatibility of the indi- mentary document is not consistent with countries, the European Free Trade Asso- vidual systems and the protection of the principles of the EHIC, which aims to ciation states and countries of the Western patient data. This is a key step towards simplify procedures and reduce red tape Balkans. accelerating eHealth implementation in for people when travelling in Europe. the EU”. The conference officially opened with a The ‘reasoned opinion’ is the second stage ministerial panel discussion, the aim of More information at www.mzcr.sk in the infringement procedure, following which was to address two overarching the first ‘letter of formal notice’. If there is questions: what are the benefits of Commission warns Spain on EU no satisfactory reply within two months, eHealth to patients and health care pensioners access to health care the Commission can refer the matter to workers, society and the economy, and On 19 February the European the European Court of Justice in Luxem- what are the main obstacles to the devel- Commission sent a reasoned opinion to bourg. opment of eHealth services among the Spain for failing to comply with EU legis- member states? The conference ran in lation on social security rights for people Report on cross border health care parallel sessions and during the two-day travelling in Europe. The Commission adopted by Parliamentary committee programme, more than fifty experts from takes the view that Spain discriminates Proposals for a directive for cross border across Europe presented their views and against EU pensioners by refusing them health care were adopted by the European opinions. access to free medication when they stay Parliament’s environment, public health temporarily in Spain. “Primarily, eHealth brings benefits to and food safety committee (ENVI) on 31 patients and health care workers. It gives EU Social Affairs Commissioner March. It aims to ensure that there are no doctors easier access to information on Vladimír Špidla said, “European legis- obstacles to patients seeking care in a patient health, the possibility to control lation guarantees everyone in the EU the member state other than their home one.

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It also clarifies the right to be reimbursed their home country. They added that or delayed service. The current system has after a treatment in another member state. member states may decide to cover other too often caused people unnecessary These rights have been confirmed by the related costs, such as therapeutic confusion at a particularly vulnerable time European Court of Justice, but are not yet treatment and accommodation and travel in their lives and it is essential that we included in EU legislation. At the same costs. provide greater clarity and legal time, the directive aims to ensure high- certainty.” He added that the “directive Since the proposed rules would in practice quality, safe and efficient health care and will enable patients to seek treatment mean that patients need to pay to establish health care cooperation mech- across the EU with a greater sense of beforehand and get reimbursed only later, anisms among member states. confidence and certainty. It is particularly MEPs added a provision that member important that this system is not exclusive The ENVI’s report, drafted by MEP John states may offer their patients a system of and bases a patient’s right to treatment on Bowis (EPP-ED, UK), was adopted with voluntary prior notification. In return, their needs and not their means.” thirty-one votes for, three against and reimbursement would be made directly twenty abstentions. Members of the by the member state to the hospital of The ENVI report can be accessed at Socialist (PES) group abstained during the treatment. MEPs said member states must http://www.europarl.europa.eu/sides/get final vote, since the Committee did not ensure that patients having received prior Doc.do?pubRef=-//EP//NONSGML+ follow their request to add Article 152 authorisation, will only be required to REPORT+A6-2009-0233+0+DOC+ concerning action in the field of public make direct payments, to the extent that PDF+V0//EN&language=EN health as a second legal basis for the this would be required at home. The proposal, which is based on Article 95 Commission is to examine whether a 112: Commission says EU single emer- (internal market) and since they wanted clearing house should be established to gency number must get multilingual clearer the rules regarding the prior facilitate the reimbursement of costs. The European emergency number 112 authorisation. Further amendments have was introduced in 1991 to provide, in been tabled ahead of the debate and first Exceptions for patients with rare diseases addition to national emergency numbers, reading vote of the whole Parliament on or disabilities a single emergency call number in all EU 23 April. The committee added special rules for member states to make emergency services more accessible, especially for Directive for patients – national compe- patients with rare diseases and disabilities travellers. Since 1998, EU rules have tences and existing rights are respected that might need special treatment. Patients affected by rare diseases should have the required member states to ensure that all In the committee vote, MEPs underlined right to reimbursement even if the fixed and mobile phone users can call 112 that the proposal is about patients and treatment in question is not provided for free of charge. Since 2003, telecoms oper- their mobility within the EU, not about by the legislation of their member state. ators must provide caller location infor- the free movement of service providers. Special costs for people with disabilities mation to emergency services so that they They also stressed that the directive fully must also be reimbursed under certain can find accident victims quickly. EU respects the national competences in conditions. Furthermore, all information member states must also raise citizens’ organising and delivering health care and must be published in formats accessible to awareness of 112. that it does not oblige health care people with disabilities. While 112 complements existing national providers in a member state to provide emergency numbers, Denmark, Finland, health care to a person from another Information to patients and the Netherlands, Portugal, Sweden and member state. The Committee pointed establishment of a European Patients most recently Romania have decided to out that the new directive will not affect Ombudsman make 112 their main national emergency current patient rights, which are already MEPs agreed with the proposal that number. In other countries, 112 is the codified under another EU regulation, or national contact points shall be estab- only emergency number for certain emer- the regulations on the coordination of lished, to increase access to information gency services (such as Estonia and social security systems. for patients. They also proposed estab- Luxembourg for ambulances or fire Prior authorisation for hospital treatments lishing a European Patients Ombudsman, brigades). Moreover, since December to deal with patients’ complaints with 2008, EU citizens have been able to The committee agreed with the possibility regard to prior authorisation, reim- contact emergency services from of introducing a system of a prior autho- bursement of costs or harm once all anywhere in the European Union by risation for the reimbursement of the complaint options within the relevant dialling 112, the EU-wide emergency costs of hospital care, but wanted member member state have been explored. number, free of charge from both fixed states to define what hospital care is and and mobile phones. not the Commission, as originally Long term care and organ transplantation proposed. It also underlined that the prior excluded from the directive Despite this, only one in four Europeans authorisation requirement must not create knows that this life-saving number exists According to the committee, the directive an obstacle to the freedom of movement in other member states and almost three should not apply to long-term care and to of patients. in ten 112 callers in other countries have organ transplantation. encountered language problems. The Reimbursement of costs to be made easier Speaking after the vote on the report, Commission, along with the European On the reimbursement of medical costs John Bowis commented that “patients Parliament and the Council, declared 11 incurred, MEPs agreed with the general have a right to seek treatment across the February ‘European 112 Day’ to spread rule that patients are to be reimbursed up European Union if their national health the word about 112 and push national to the level they would have received in provider has let them down with a poor authorities to make the EU’s single emer-

41 Eurohealth Vol 15 No 1 MONITOR gency number more multilingual. The countries, from 3% in Italy to 58% in By signing the memorandum of under- Commission and member states are then the Czech Republic. Many member states standing, Dr Nata Menabde, WHO expected to step up their efforts to are informing their citizens and visitors Deputy Regional Director for Europe, publicise 112, especially before the about 112, for example, in Finland 112 and Dick Tromp, EuroPharm Forum summer holiday period. day is celebrated annually on 11 February President, have agreed to continue the while visitors to Bulgaria receive a collaboration between their organisations. “The European emergency number welcome text message informing them They have also agreed that further discus- should no longer be Europe’s best kept about 112. 112 is publicised on sions will take place as a matter of course secret. We have a single emergency motorways and toll gates in Austria, to define and develop additional areas of number, 112, that works for every Greece and Spain and at train stations and collaboration for the future. emergency and every member state and airports in Belgium, the Czech Republic, every citizen that needs it. But it is “Pharmacists are an integral part of the Estonia, Ireland, Greece and the Nether- unacceptable that less than a quarter of health system. They assume varied func- lands, among others. At least a 10% citizens are aware of 112, or that language tions ranging from procuring and increase in awareness of 112 was seen in barriers prevent travellers calling 112 supplying medicines to pharmaceutical Bulgaria, Sweden, Romania, Lithuania, care services, helping to ensure the best from communicating with the emergency and Portugal in the past year. operator,” said EU Telecoms Commis- treatment for patients”, said Dr Menabde. sioner Viviane Reding. “The EU must The Eurobarometer survey also showed “Sharing the best practice models will work to guarantee the safety of our 500 that a quarter of EU citizens have called allow us to make better use of resources million citizens with the same intensity as an emergency number in the last five and have a greater impact on pharmacies’ we have worked to guarantee their ability years. The majority of calls were made role in public health.” from fixed lines: while 53% of calls were to travel freely across the borders of Dick Tromp expressed satisfaction that made from a fixed line, there was an twenty-seven countries. Europe’s first 112 the memorandum of understanding could increase in emergency calls made from day should act as a wake up call to be established saying that "we have a mobile phones (45% compared to 42% in national authorities who need to improve long-standing tradition of working very 2008). the number of languages available in their closely with WHO Regional Office for 112 emergency centres and boost More information available at Europe for the benefit of our members. awareness about this life-saving number.” www.ec.europa.eu/112 With the signing of this memorandum, we An EU-wide survey conducted for the affirm the value of this partnership and set European Commission shows that 94% New guidelines for pharmacists to be the stage for future joint activities. The of EU citizens think it is useful to have a developed close collaboration with WHO is single emergency number available in the The WHO Regional Office for Europe important, since it emphasises the phar- EU. The Eurobarometer survey also and EuroPharm Forum, a joint network macist’s role in health care.” of professional associations of pharma- highlighted areas where there is still room The memorandum of understanding is cists from countries in the WHO for improvement. available at http://www.euro.who.int/ European Region, will join efforts to pharmaceuticals/20090330_1 Language problems support organisations of European phar- 28% of callers have language problems macists in developing the best practice when they call 112 while abroad, despite models. The models to be developed will the fact that information provided by 21 provide practical and cost-effective COUNTRY NEWS member states indicates that their 112 examples that can be used in chronic emergency centres should be able to diseases, mental disorders, obesity, Nordic council to debate increase in TB handle calls in English (12 member states palliative care and other sectors. Together in German, 11 member states in French, 4 with WHO, the EuroPharm Forum will and HIV/AIDS in north-west Russia member states in Italian). A number of develop and make these models available The Nordic Council, a body established member states have also indicated the to all countries through its Observatory in 1952 between the parliaments of ability of their emergency call centres to on Pharmacy Practice. Denmark, Finland, Iceland, Norway and Sweden, is looking at ways to tackle the answer calls in the languages of their A memorandum of understanding recent dramatic increase in multi-resistant neighbouring EU countries, while in between the two organisations was signed tuberculosis and HIV/AIDS that has been some others, such as the UK and Sweden on 30 March in Copenhagen. The overall observed in north-west Russia. The emergency call centres can use an inter- objective is to help them in developing Council’s Welfare Committee has brought pretation service covering all major services and skills to increasingly meet together different experts from within languages (170 languages in the case of the patients’ needs. Both WHO and the authorities, institutions and organisations UK). EuroPharm Forum recognise that phar- to participate in a conference in Kalin- macists have been faced with increasing Awareness of 112 ingrad on 29 and 30 April. The objective is health demands that extend beyond to find partners and projects for a more Overall, only 24% of surveyed Europeans selling medicine. Pharmacists have a vital effective cooperation against these life- could spontaneously identify 112 as the role to play in efforts to provide safe and threatening diseases. number on which they can call emergency effective medicines, helping to ensure the services anywhere in the EU. This is a best treatment for patients and save lives. Meeting in Copenhagen on 16 and 17 2% improvement since February 2008 The memorandum of understanding aims April, the members of the Committee but knowledge varies greatly between at strengthening this role. issued a joint communiqué stating that

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“the increase of the life-threatening associated TB are fast growing challenges. then benefit from the transitional period. diseases tuberculosis and HIV/AIDS is a The Russian Ministry of Health did However, many companies did not serious threat to the population in north though give an assurance of its manage to submit all the documents west Russia. As neighbours we must give commitment to continued support for TB required for the authorisation of their the necessary support to turn this negative control, including the centralised products, or when they submitted such trend and in this way contribute to a procurement of key TB drugs at the documentation, the Minister did not have positive development of the quality of life national level, despite the financial hard- enough time or resources to review the in the area” ships and new challenges. The Federal documentation. This led to the Minister Correctional Service also highlighted of Health taking action that did not At the conference parliamentarians in the improved TB control in the penitentiary comply with EU law, and led to multiple Nordic Council’s Welfare Committee will legal problems and disputes and a number endeavour to develop best practice sector. of so-called ‘ghost drugs’. models. They have also proposed that this The press conference included an award work will be carried out by the Expert ceremony for the winners of the In order to allow products to ‘squeeze’ Group on HIV/AIDS, TB and multi- children’s poster contest “I am helping into the transitional period, the Minister drug resistant TB that already exists fight TB!” The contest included submis- of Health issued marketing authorisations within the Northern Dimension Part- sions from around twenty regions, without reviewing the submitted dossiers, nership in Public Health and Social Well- ranging from the Khakasiya Republic to with conditions obliging the marketing being. The MPs’ proposal will be the Vladimir region. The contest, which authorisation holders to submit the regis- discussed by the Nordic Council has been part of World TB Day events for tration documentation after the authori- Presidium, following which it is expected eight years, has the aim of raising sation had been approved. Those to be forwarded as a recommendation to awareness among school students about conditional marketing authorisations, the Nordic Council of Ministers for TB and equipping them with knowledge granted without prior review, were chal- consideration. about early symptoms and basics of TB lenged in Polish courts and were there- after ruled unlawful. The conclusion as to Further information at prevention, as well as the need to live a their unlawfulness was also widely shared http://www.norden.org/nr/utskott/valfa healthy life. by academics and the highest institutions rd/uk/index.asp More information at of public control, such as the Supreme http://www.unrussia.ru/en Chamber of Audit. Russia: Press conference marks World TB Day 2009 Poland: End of transitional period for The European Commission found that by On 24 March, World Tuberculosis Day, pharmaceuticals issuing conditional authorisations on the over thirty Russian and international 31 December 2008 marked the end of a eve of accession, Polish authorities partners and around twenty mass media transitional period for pharmaceutical breached the Accession Treaty and representatives as well representatives of products awarded to Poland in the submitted a complaint against Poland to government, academic, non-govern- Accession Treaty, which came into force the European Court of Justice on 2 mental and international technical, on 1 May 2004. The transitional period September 2008 (case C-385/08). A humanitarian and donor organisations was meant to ‘protect’ products marketed similar case has been taken by the attended a press conference. The in Poland against the need to become Commission against Lithuania (case C- conference included representatives of the compliant with EU pharmaceutical law 350/08). Russian Federal Ministry of Health, (including much stricter legal require- The termination of the transitional period Russian Federal Ministry of Justice, ments than Polish pre-accession pharma- on 31 December 2008 brought about WHO, UNAIDS and the Global Fund ceutical law) immediately upon Poland’s additional problems, particularly as Tuberculosis project in Russia. accession to the EU. regards the fate of products that were The keynote speaker, Professor Mikhail I. According to Annex XII to the Accession denied an upgrade. (According to the data Perelman, Chief TB Specialist of Russia, Treaty, all products which: (i) were published by the Minister of Health, Director of the Institute of Phthisiology included in the list provided in Appendix 6,771 pharmaceutical products were and Pulmonology of the Moscow Medical A to Annex XII to the Accession Treaty, successfully upgraded during the transi- Academy and a Member of the Russian tional period, while 177 products were and (ii) for which marketing authorisa- Academy of Medical Sciences, charac- denied an upgrade.) Typically, the denial tions were issued under Polish law prior terised the TB situation in the country as of extension of validity of the marketing to the date of accession (before 1 May ‘tense’, but acknowledged good political authorisation means that a product may 2004) could benefit from the over four support for TB control at the national still be manufactured and put on the and a half year-long transitional period for level and called for more support at market for six months following the upgrading to the requirements of quality, regional level. He stressed that Russia had denial. In the case of non-upgraded safety, and efficacy laid down in Directive achieved noticeable improvement in TB products, the Minister of Health adopted 2001/83. Such products could not, incidence and mortality in the past few the interpretation issued by the Office of however, be subject to the mutual recog- years but that much more needed to be the Committee for European Integration, nition procedure in other member states. done. The risk of TB may increase due to which indicated that this six month period social stress, rising unemployment, falling There was a great incentive for companies may not go beyond 31 December 2008; personal earnings, and poorer nutrition to obtain marketing authorisations for thus, the non-upgraded products could caused by the financial and economic their products prior to Poland’s accession only be put onto the market until 31 crisis. Multi-drug resistant TB and HIV- to the EU, because their products would December 2008.

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When marketed, such products may stay use. There is no need to submit medical / medicine in a cost effective way. A on the market until their expiry date. At scientific literature if the NIP had already shortlife working group involving key the same time, however, the General approved the off-label use of the medicine stakeholders has been considering the Pharmaceutical Inspector, in cooperation for the indication concerned. basis on which patient access schemes with the Minister of Health, issued a very could operate in Scotland through a The NIP must assess the applications for lenient interpretation of the notion of national framework. off-label use within twenty days from the “putting on the market”, equating it with request being filed but in urgent cases the There are also plans for the SMC to the date of batch release. The companies NIP must proceed immediately and make publish the ‘modifiers’ which it uses when that are denied upgrade are also asked to a decision within two days. The NIP considering new medicines so that special provide the General Pharmaceutical publishes statements on its homepage circumstances can be taken into account. Inspector with detail of the batches of regarding the assessment of individual New guidance for NHS Boards on the products that were released before 31 requests for off-label use of medicines. end-to-end process for the introduction December 2008 and that will be in trade The physician prescribing the medicine of new medicines and a new framework circulation until their expiry date. off-label must provide the patient with to enable a consistent approach to the information about the proposed principles applied for ‘exceptional Hungary: Off-label use of medicines to treatment and must seek the patient’s prescribing’ will be developed. Health be allowed approval to the off-label use of the Rights Information Scotland has also been The laws in Hungary, for many years, medicine. He or she must keep proper commissioned to produce new infor- have strictly prohibited physicians from records on any off-label prescribing. mation for the public on the revised prescribing registered medicinal products arrangements and guidance which will for other than their approved indications. Despite this recent decision, it should be come into place. As a general rule, off-label use was noted that Hungarian laws still strictly considered to be a clinical trial, which if prohibit marketing, advertising or Since 2008, the Scottish Parliament’s carried out without a proper licence may otherwise promoting of the off-label use Public Petitions Committee has been have even resulted in criminal sanctions. of drugs. The new Hungarian regulation undertaking an inquiry into the avail- represents a delicate balance between the ability on the NHS of cancer treatment Act XCV of 2005 on Medicines Intended regulatory objective of protecting patients drugs. The Scottish Government for Human Use (the “Medicines Act”) from, on the one hand, unsafe or inef- responded formally to the Committee in and Decree 44/2004 (IV. 28.) of the fective drugs and, on the other hand, the September 2008. Exceptional prescribing’ Minister of Health on the Prescription prerogative of physicians to use their arrangements are in place in each NHS and Supply of Medicines Intended for professional judgment in treating patients. Board in order to consider the circum- Human Use (the ‘Decree’) have recently stances of individual patients where their been amended to allow off-label Scotland: Focus on access to new clinician wishes to prescribe a drug not prescribing and the use of medicines, medicines recommended by the SMC or NHS QIS provided compliance with the following The NHS in Scotland will offer staff, following a National Institute for Health detailed conditions is ensured. patients and the public a better under- and Clinical Excellence Multiple Tech- A physician may prescribe a medicine for standing of the processes and decisions nology Appraisal. use other than its approved indication if: involved concerning new medicines, it has been announced. Making a statement to The Health Secretary’s statement can be (i) the treatment of the patient with other the Scottish Parliament, on March 25 accessed at http://www.scotland.gov.uk/ approved medicines is not possible or is Health Secretary Nicola Sturgeon News/This-Week/Speeches/Healthier/ shown to be unsuccessful, and based on described the ‘substantive progress’ made medsprvtecare available evidence, there is a chance to over recent months to improve arrange- improve or stabilise the health status of ments for introducing new medicines into Germany: Drug use to improve work- the patient with the off-label application the NHS in Scotland and the guidance in place performance on the increase of the medicine; place to support this. While Germany tries to combat doping in sports, drug abuse amongst office (ii) the medicine is registered either in The announcement builds on Scotland’s workers in the country is on the rise, Hungary or in another country; and long standing arrangement for the intro- according to a study published by duction of new medicines through the (iii) an approval has been received from German health insurer Deutsche Scottish Medicines Consortium (SMC) the National Institute of Pharmacy (NIP) Angestellten-Krankenkasse (DAK). As and NHS Quality Improvement Scotland in response to a request for the off-label long-distance drivers on amphetamines or (QIS). The new measures include the use of the medicine for the relevant indi- classical musicians on beta-blockers introduction of patient access schemes in cation. become less surprising in today’s society, Scotland, a proposal that has been put more people in varied industries are The request for approval from the NIP forward by manufacturers to improve the resorting to prescription drugs to improve must contain certain information, cost effectiveness of a new drug. Such workplace efficiency or simply lift their including the medical history of the schemes can operate when a product has mood, the study said. patient, detailed data on the medicinal been launched on the market but is being product and indication for which it will assessed for introduction into the NHS. DAK questioned some 3,000 employees be prescribed and the professional reasons An arrangement can be considered between the ages of twenty and fifty years for the off-label prescription, as well as between the manufacturer and the NHS and researched some 2.5 million insurance medical literature to support the off-label to help the NHS secure access to the records to find out more about doping in

Eurohealth Vol 15 No 1 44 MONITOR the workplace. Almost two million were between 1981 and 2005 while the Food the information. Gathering this data will found to have already used certain Standards Agency’s National Diet and inform the next steps for a wider rollout remedies to cope with increasing stress Nutrition Survey shows men get 25% of of calorie labelling on menus. levels at work, while 800,000 people regu- total food energy intake and women get Research published by the Food Stan- larly and intentionally used antidepres- 21% of energy from eating out of the dards Agency published in 2008 indicated sants or prescriptions meant to treat home. that consumers would welcome simple, dementia or attention deficit hyperactivity The new list of companies includes work- clear and visible nutrition information disorder. They often named colleagues, place caterers, sit down and quick-service when eating out. This research followed a friends, family and the internet as the restaurants, theme parks and leisure survey carried out by the Agency in June sources of supply, the study revealed. attractions, pub restaurants, cafes and 2008, which suggested that 85% of The survey looked at those engaged in sandwich chains. Companies involved consumers agreed that restaurants, pubs jobs involving greater stress, less security include a number of well-known high and cafes have a responsibility to make and the pressure to achieve results. street names and several major contract clear what is in the food they serve. More Academics in particular were prone to use caterers including Burger King, Kentucky than 80% of respondents said that medication to enhance their ability to Fried Chicken, Pizza Hut, Pret A Manger, nutrition information would be most combat fatigue and increase performance. Sainsbury’s Cafes, Subway, Waitrose useful if provided at the point they choose Four in ten people said they knew Cafes and Wimpy. to order food, such as on menus or menu prescriptions meant to fight illness-related This it is hoped will benefit individuals boards. memory loss or mood swings can also and families who are trying to choose a The names of the eighteen companies have an effect for healthy people. Mean- healthier diet and follows experience in introducing calorie information on their while, two in ten people questioned said New York where in April 2008 the City menus are also published in the first they considered the benefits of taking Board of Health passed a law which annual report of the Government’s performance-enhancing prescription obliged some restaurants to list calories on obesity strategy in England, ‘Healthy drugs to outweigh the risks and side their menus. By June, more than 450 food Weight, Healthy Lives – One Year On’. effects. The study also showed the differ- outlets across the country will have intro- The report sets out the Government’s ences in doping between men and women. duced calorie information - some of these efforts to tackle obesity over the last year While men preferred efficiency-increasing will be on a pilot basis. Each company has and plans going forward. The strategy supplements, their female co-workers agreed to display calorie information for included the challenge to industry as a often resorted to sedatives. most food and drink they serve; print whole to provide information on the Speaking to the Berliner Zeitung DAK calorie information on menu boards, nutritional content of food in a wide head Herbert Rebscher called the study paper menus or on the edge of shelves; range of settings in a manner which is results an “alarm signal,” although work- and ensure the information is clear and clear, effective and simple to understand. place doping is not yet a widespread trend easily visible at the point where people For a full list of the companies involved due to fears of side effects while the choose their food. and more information on healthy food employers’ trade association the BDA Commenting on the announcement Ms commitments by the industry see said that the abuse of prescription drugs Primarolo said that “we know that people http://www.food.gov.uk/ needs to be seen as a serious problem. want to be able to see how many calories healthiereating/healthycatering/ Ministry of Health spokesman Klaus are in the food and drink they order when cateringbusiness/commitments Vater also told the paper that the study is they eat out. I want to see more catering being taken seriously by the German companies join this ground breaking first Channel Islands: End of reciprocal Health Ministry. In 2008 the number of group to help their customers make health care agreement with UK sick days employees took off from work healthier choices.” The Channel Islands, located just off the increased by almost 8%. Tim Smith, chief executive of the Food coast of Normandy, are British Crown Dependencies that are internally self- England: Restaurants and catering Standards Agency said that “we are governing and have their own health companies bring in calories on menus pleased that such a diverse range of companies has agreed to work with us by services separate from the UK NHS. On 6 April it was announced that introducing calorie labelling at the crucial Since 1 April UK residents visiting the eighteen major catering companies, point where their customers make a Channel Islands must ensure they have including many high street brands, will decision about what to eat. Our aim is to adequate travel insurance. The recom- introduce calorie information on their ensure that consumers have better infor- mendation comes from the UK menus for the first time. The list of trail- mation so they can make informed Department of Health given the end of blazers, announced by Public Health choices to improve their diet when eating the reciprocal agreement on health care Minister, Dawn Primarolo and the Food out, whether that is a snack on the go, a arrangements for UK visitors on 31 Standards Agency will start displaying meal in a staff restaurant or at a table March 2009. Travellers cannot rely on calorie information from the end of April. being served by a waiter.” cover from the European Health A number of restaurant chains already Insurance Card scheme as the islands are provide information in their outlets or on Independent research will assess how not part of the EU. company websites, regarding salt, fat and easily customers understand and use the sugar in their products. According to system and gather feedback from the The previous agreement which had been British Hospitality Association, the restaurants themselves to look at practical in place since 1976, allowed UK travellers catering sector has seen sales triple issues and the costs involved in providing to get a limited number of medical treat-

45 Eurohealth Vol 15 No 1 MONITOR ments in the Channel Islands free of of common diagnostic and treatment group reflecting the progress and devel- charge. Even with this agreement in place, procedures, transport services, pharma- opments made in the implementation of UK tourists had always been charged for ceutical and medical device expenditures the recommendations of the National a number of health care services including and patterns of service use. The move has Taskforce on Obesity since its publication prescribed medicines, accident and emer- been welcomed by the Health Policy in 2005. The Group, established by the gency hospital treatment, emergency Institute which believes that they can Minister in December, 2008, comprises dental treatment, GP and other medical contribute to a more objective view of the representatives of all stakeholders, care, ambulance travel (in Guernsey/ Slovak health care system. including experts from government Alderney) and for GP treatment, dental departments and agencies, the food The law on health insurance mandates care and prescribed medicines (in Jersey) HICs to establish and make public their industry and relevant non government and all medical treatment in Sark. criteria for provider contracting at least organisations. Since 1 April anyone travelling to the once every nine months. These criteria Speaking at the launch, the Minister Islands, which include Guernsey, Jersey, include staff mix, access to specialist pointed to the fact that the most recent Alderney, Sark and Herm, has been equipment, certification of quality and use Survey of Lifestyles, Attitude and required to pay for all medical treatment of quality indicators. Each HIC ranks Nutrition or SLAN 2007 Report, indi- should they become ill or injured. Poten- providers based on these criteria and cates that 38% of the population is over- tially many tourists from the UK will be should take this into consideration when weight and a further 23% are obese. caught unawares, expecting to be entitled entering into contractual agreements. Therefore, 61% of the population are to the same care received in the UK. Last There are however differences in the either overweight or obese. Of particular year there were 53,200 visitors from weights given to different criteria by concern, was the increasing levels of London to Jersey and 40,000 to Guernsey different HICs. While many private HICs obesity in children. Recent research alone. Because their currency is tied to the have attached a weight of 50% to quality reveals that 26% of seven-year old girls UK pound, they are expected to be indicators, public HICs have only allo- and 18% of seven-year old boys are over- popular holiday destinations in 2009 due cated 10% to existing indicators. weight or obese. to the weakness of the pound. “We adjusted some indicators, added It is estimated that obesity is responsible Although no official reason for the change economic indicators and, in particular, for around 2,000 premature deaths in in policy has been given, the agreement included indicators based on data Ireland each year. The indirect cost of had been a significant revenue generator collected by HICs from service obesity in Ireland is estimated at €0.4 for the Channel Islands. The end of the providers” said Minister of Health billion, per annum. “The importance of agreement will for instance mean a Richard Raši. The Health Ministry in halting the rise in obesity is therefore reduction of £3.9 million in revenue for compiling the new set of indicators has critical”, said the Minister. While the the health system in Jersey. Jersey thus tried to eliminate subjective influence report pointed to significant progress in Health’s finance director, Russell Pearson, when data is submitted. “The HICs will the implementation of the Taskforce’s has already warned that that could mean be able to retrospectively evaluate recommendations, Minister Wallace said Jersey patients suffer. Speaking to the whether providers submitted the correct “we must re-double our efforts to row Jersey Evening Post he said that ‘Health data,” the Minister further explained. The back the rising tide of overweight and and Social Services cannot afford to take a Ministry also plans to centrally evaluate obesity. It is not going to be an easy task, reduction of £3.9 million,’ adding that ‘we HICs by also analysing data from service involving as it does, changing our own would have to prioritise and reduce providers. and especially our children’s attitudes and services.’ Channel Islanders will also be The indicators cover inpatient, general behaviour in relation to eating patterns liable for charges for non-emergency and specialised ambulatory care. For and levels of physical activity. We must medical treatment when visiting the UK. hospitals, indicators include measures of continue to work to make it easier for More information at http://www.thisis surgery, repeat surgery, readmission rates people to make the healthy choices jersey.com/2009/03/03/health- and overall mortality. For general practi- required for them to take better care of agreement-with-uk-to-end-next-month/ tioners, for example, indicators include themselves and to lead healthy lives, to rates of utilisation and use of preventive literally invest in themselves and their Slovakia: Government approves new measures. According to Raši, differences futures.” quality indicators in rates of mortality for the same Chief executive of the all-island Institute As reported by the independent Bratislava condition between facilities may poten- of Public Health in Ireland (IPH), Dr. based thinktank, the Health Policy tially lead to an investigation to determine Jane Wilde, welcomed the Minister’s Institute (www.hpi.sk), health insurance whether this is due to differences in statement on the need to re-double efforts companies (HICs) will assess health care patient case mix or mistakes made during in tackling obesity and her commitment providers making use of a new set of service provision. to taking a cross-government approach, quality indicators, following the approval noting that “most of the actions needed to of a new regulation by the Slovakian Ireland: Obesity Taskforce report prevent obesity fall outside the health government. Although the government launched sector and a much wider societal response came to power in 2006 this is the first time On 17 April Mary Wallace, Minister of is required.” that the quality indicators have been State at the Department of Health and updated. According to the regulation the Children with special responsibility for Dr Wilde added that “it is essential that purpose of the indicators is to obtain Health Promotion and Food Safety the food industry acts responsibly on relevant information on the effective use launched a report of an intersectoral issues such as the composition of food

Eurohealth Vol 15 No 1 46 MONITOR products, sourcing and pricing of food lead, the pesticide DDT (dichloro- All these factors – rather than melatonin – products, simpler, consistent food diphenyl-trichloroethane), and engine could be the real reasons behind any labelling across the island and controls on exhaust. apparent cancer links. For instance, marketing in the media and in-store explains Arney, “we know that breast The next step is for the Board to review promotions – particularly those aimed at cancer is more common in inactive the work of the International Agency for children – as well as the location and women, so if shift workers get less Research on Cancer (IARC) in this field content of retail food outlets.” exercise than the general population, this and to decide if breast cancer after night- could explain their higher risk.” A repre- The IPH is establishing an Obesity shift work should be included on the list sentative from the UK’s Health and Safety Knowledge Centre to support implemen- of occupational diseases. Executive told the BBC that they had tation of obesity strategies, North and Ulla Mahnkopf, who developed bilateral commissioned their own report on the South. The Centre will widen access to breast cancer after working for thirty link between shift work and breast cancer data, evidence and good practice; help years as a flight attendant for SAS, told and were expecting it to be finished in develop evidence about what works and BBC Scotland she had “no idea” her work 2011. what doesn’t, and help implement good patterns could have caused a health risk. policy and practice. More information at http://news.bbc.co. But when you think back now I can see uk/1/hi/scotland/7945145.stm The report of the intersectoral group is that when I stopped flying it was like available at http://www.dohc.ie/ coming out of a shell,” she said. “I had Czech Republic: user fees reduced but publications/report_ntfo.html been living in there because of jet lag and not abolished I can see now I had a totally different In February the Czech coalition Denmark pays compensation to night life.” government narrowly forced through shift women with cancer Dr Vincent Cogliano of the IARC said parliament a proposal to abolish some BBC Radio Scotland reported on 16 that it believed that alterations in sleep user fees for patients below the age of March that the Danish government has patterns caused by working nights could eighteen. 99 of 196 MPs voted in favour begun paying compensation to women lower the body’s production of mela- of the proposal. Fees for emergency who developed breast cancer after tonin. This multitasking hormone keeps services, as well as for hospital stays will working night shifts. The Danish your biological clock ticking over, making continue to be enforced. For people over National Board of Industrial Injuries sure that you are alert during the day and the age of sixty-five the maximum limit reports that in 2008, breast cancer after sleepy at night. It also seems to play an for user fees and co-payments will be night-shift work was recognised as an important role in cancer protection. reduced from 5000 to 2,500 Crowns. For industrial injury in thirty-eight of prescriptions, a fee should only be seventy-five cases that were submitted to Melatonin lowers levels of the female charged if the co-payment is less than 30 the Occupational Disease Committee. hormone oestrogen in the blood - crowns. This bill does not go as far as the Compensation was granted in all but one oestrogen is known to encourage the parliamentary opposition would like: they of these cases, and was paid by the growth of certain cancers, notably breast have called for the complete abolition of employer’s industrial-injuries insurance. and ovarian cancer. It could also block the all user fees, a platform which was signif- The cases that won compensation growth of cancer cells and boost the icant in their electoral gains in regional involved women who typically worked at body’s immune system by killing cell- elections in November 2008. least one night a week for at least twenty damaging ‘free radicals’ (killing free to thirty years, and where there were “no radicals also happens to be why antioxi- The system of user fees had been intro- other significant factors that might explain dants are so prized) and block cells from duced by former Health Minister Tomáš the development of breast cancer,” the dividing. Since the brain produces the Julínek early in 2008 and was intended to Board said. most melotonin in the middle of the night reduce excessive utilisation of services and when it is dark, night- shift workers – generate additional revenue for the health The move comes after a UN health body whose bodies are saturated by artificial care system. However administration of said that working nights probably light – have abnormally low levels. the system has proved problematic; and increases the risk of cancer. The Interna- there have been conflicts between the tional Agency for Research on Cancer However according to Cancer Research regional and national administrations. (IARC) placed shift work in the same UK, any night-shift panic would be category as anabolic steroids, ultraviolet premature. “The breast cancer risk has not Although the newly elected Central radiation and diesel engine exhaust in been conclusively shown,” says Dr Kat Bohemian Governor David Rath abol- terms of cancer risk. In a statement Arney, senior science information officer ished fees in all hospitals in his region in released in December 2007, the IARC at Cancer Research UK. This is because November 2008, insurance companies said that its expert working group had there are so many complicating factors announced in February 2009 that they concluded that shift work that involves when you try to study the effects of planned to fine five Central Bohemian circadian disruption is “probably carcino- lifestyle on cancer risk. “At the moment hospitals that had not collected manda- genic to humans,” and it was ranked in we just don’t know how other lifestyle tory health fees from patients. Other group 2A, along with ultraviolet light factors, such as taking HRT, obesity, opposition Social Democrat governed radiation. This is below the group 1 having fewer children or drinking alcohol, regions have also agreed to abolish the category, which is “carcinogenic to interact with shift work to increase a fees in regional hospitals, with the costs humans,” and includes asbestos, but woman’s risk of breast cancer,” says being met entirely by these regions. above group 2A, which is “possibly Arney. carcinogenic to humans,” and includes

47 Eurohealth Vol 15 No 1 News in Brief

NICE issues guidelines on promoting EU health prize for journalists Joint conference on well-being in the physical activity for children In 2009, an EU Health Prize for Journal- workplace The National Institute for Health and ists will be awarded. The Prize is part of A joint conference on well-being in the Clinical Excellence (NICE) in England the ‘Europe for patients’ campaign, workplace took place in Berlin on 17 has issued guidance on promoting phys- launched by EU Health Commissioner and 18 March, organised by the WHO ical activity and sport for all children Androulla Vassiliou in September 2008, Regional Office for Europe and the Ger- and young people, both at school and highlighting ten health policy initiatives man Alliance for Mental Health, in with the family. The guidelines have the Commission will adopt in cooperation with the European Com- been issued following studies which 2008–2009. The Prize rewards journal- mission’s Directorate General Health show that the national recommended ists who have contributed in a significant and Consumers and supported by the levels of physical exercise for young way to help citizens understand health German Federal Ministry of Health. people are not being met, causing con- issues under the campaign, and through The conference focused on maintaining cern about the rising levels of obesity in their work reflect patients’ and health good mental health at the workplace the country. workers’ expectations and thoughts. Ar- through the social integration and em- ticles must have been published (press or powerment of vulnerable people, as well More information at on-line) between 2 July 2008 and 15 as looking at how to tackle the stigma http://www.nice.org.uk/media/185/55/2 June 2009 in one of the official languages and prejudices relating to mental health 009002PromotingPhysicalActivity of the European Union. All participants problems. ForChildren.pdf must be nationals or residents of an EU More information at Member State and registered journalists. Experts meet to discuss health impli- http://www.mental-wellbeing.net/ Articles must be submitted through on- cations of global economic crisis line entry form. The Prize will be The global economic downturn occurs EU Health Policy Forum awarded in autumn 2009. as the world is confronted with the con- The EU Health Policy Forum (EUHPF) sequences of major demographic More info at http://ec.europa.eu/health- aims to bring together umbrella organi- changes and global environmental/en- eu/europe_for_patients/prize/index_en. sations representing stakeholders in the ergy problems. With the economy slow- htm health sector to ensure that the EU`s ing down and unemployment rising, the health strategy is open, transparent and living conditions of millions of individu- New OCED working paper analysing responds to the public concerns. The in- als in Europe are seriously threatened or trends in obesity tention is to provide an opportunity to already affected, as is the revenue base of A new working paper authored by organise consultations, to exchange health and social protection schemes. Franco Sassi, Marion Devaux, Michele views and experience and assist in imple- Cecchini and Elena Rusticelli provides mentation and follow-up of specific Overcoming the crisis will require an overview of past and projected future initiatives. timely, well targeted, fully coordinated trends in adult overweight and obesity efforts. Experts met in Oslo on 1–2 A meeting of the forum was held on 21 in OECD countries. Projected future April at a meeting organised by Norwe- January in Brussels. The significant im- trends show a tendency towards a pro- gian Ministry of Health and Care Serv- pact of the financial crisis on health was gressive stabilisation or slight shrinkage ices, in partnership with the WHO the most pressing issue, and the need to of pre-obesity rates, with a projected Regional Office for Europe, to discuss act quickly led to the drafting of an continued increase in obesity rates. As- how the health sector can help reduce Open Letter calling for action. Concern- pects of physical, social and economic negative health and social impacts and ing the implementation of the Health environments that favour obesity have counter the economic downturn. It also Strategy, the European Commission felt been consolidating in the last thirty considered the advice given by it was important for the EUHPF to con- years. But the long term influences of WHO/Europe to its Member States. tribute to the implementation of the changing education and socioeconomic strategy and will be collecting inputs on The Oslo meeting is one of a series of conditions have also made successive the specific priorities. meetings looking at health and the ongo- generations increasingly aware of the ing global crisis. A high-level consulta- health risks associated with lifestyle More information at tion on financial crisis and global health choices, and sometimes more able to http://ec.europa.eu/health/ph_overview/ was held in Geneva in January 2009. The handle environmental pressures. Varia- health_forum/policy_forum_en.htm 62nd World Health Assembly in May tions in obesity status by education and and 59th session of the WHO Regional socio-economic condition, and the influ- Committee for Europe in September ence of health-related behaviours, partic- will also allow for further comprehen- ularly those concerning diet and Additional materials supplied by sive discussions physical activity, are also highlighted. EuroHealthNet Further information and materials from The working paper can be downloaded 6 Philippe Le Bon, Brussels. the meeting are available at at http://www.olis.oecd.org/olis/2009 Tel: + 32 2 235 03 20 http://www.euro.who.int/healthsys doc.nsf/LinkTo/NT00000EFE/$FILE/J Fax: + 32 2 235 03 39 tems/econcrisis/20090316_1 T03261624.PDF Email: [email protected]

eurohealth Vol 15 No 1 48 Eurohealth is a quarterly publication that provides a forum for researchers, experts and policy makers to express their views on health policy issues and so contribute to a constructive debate on health policy in Europe

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