Eurohealth RESEARCH•DEBATE•POLICY•NEWS Volume 14 Number 3, 2008

Medical devices: exploiting the potential in Europe

Procurement of medical devices in England: application to wound care

Reference pricing for medical devices in Germany

Financing medical devices in Italy: cardiovascular technologies

e-Health in Canada • Community pharmacy in the 21st Century • Development of a case mix system in Japan OTC pharmaceutical market – policy and practice • Cancer control in Europe • Health Insurance in Moldova Medical devices: exploiting the Eurohealth potential LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom C Medical devices, large and small, that are vital to the fax: +44 (0)20 7955 6090 www.lse.ac.uk/LSEHealth functioning of health care systems, are the focus of much of this issue of Eurohealth. These devices are also Editorial Team significant to the European economy: in 2005 alone EDITOR: the European medical technology industry generated David McDaid: +44 (0)20 7955 6381 email: [email protected] sales of more than €63.6 billion, while investing more O FOUNDING EDITOR: than €3.5 billion in research and development and Elias Mossialos: +44 (0)20 7955 7564 employing 435,000 skilled workers. In their overview email: [email protected] article, Elio Borgonovi, Reinhard Busse and Panos DEPUTY EDITORS: Kanavos argue that much more can be done to Sherry Merkur: +44 (0)20 7955 6194 email: [email protected] optimise the value, effectiveness and efficiency of Philipa Mladovsky: +44 (0)20 7955 7298 M email: [email protected] medical devices in Europe. They call for further evidence to demonstrate the numerous benefits arising EDITORIAL BOARD: Reinhard Busse, Josep Figueras, Walter Holland, from investments in such technology, and, in parallel, Julian Le Grand, Martin McKee, Elias Mossialos

to look at how the dynamics of coverage, procure- SENIOR EDITORIAL ADVISER: ment, reimbursement, and diffusion operate across Paul Belcher: +44 (0)7970 098 940 M different health systems and regulatory environments. email: [email protected] Contributions looking at different approaches and DESIGN EDITOR: Sarah Moncrieff: +44 (0)20 7834 3444 experience in Italy, Germany and England also feature email: [email protected]

in this issue. SUBSCRIPTIONS MANAGER Champa Heidbrink: +44 (0)20 7955 6840 We are also delighted to publish an article by Delia- email: [email protected] E Marina Alexe and colleagues on the challenges posed Advisory Board by cancer in Europe today and measures available to Anders Anell; Rita Baeten; Nick Boyd; Johan Calltorp; tackle this problem. They call for a much more Antonio Correia de Campos; Mia Defever; Nick Fahy; Giovanni Fattore; Armin Fidler; Unto Häkkinen; Maria integrated approach to cancer control, including the Höfmarcher; David Hunter; Egon Jonsson; Meri Koivusalo; development of national coordinated cancer plans, as Allan Krasnik; John Lavis; Kevin McCarthy; Nata Menabde; Bernard Merkel; Stipe Oreskovic; Josef Probst; N well as investment in effective cancer information Tessa Richards; Richard Saltman; Igor Sheiman; Aris systems including screening registries. At an EU level Sissouras; Hans Stein; Jeffrey L Sturchio; Ken Thorpe; Miriam Wiley the authors note that the Data Protection Directive may impede the effective operation of cancer registries Article Submission Guidelines and requires reform, while further steps can be taken see: www.lse.ac.uk/collections/LSEHealth/documents/ to tackle health inequalities and promote strategies to eurohealth.htm combat aspects of unhealthy lifestyles such as tobacco, Published by LSE Health and the European Observatory T on Health Systems and Policies, with the financial support alcohol and poor nutrition that are risk factors for of Merck & Co and the European Observatory on Health cancer. Systems and Policies. Eurohealth is a quarterly publication that provides a forum for researchers, experts and policymakers to express their Among other contributions to the issue are two views on health policy issues and so contribute to a perspectives on aspects of health reform from outside constructive debate on health policy in Europe. Europe. One looks at the use of e-Health in Canada The views expressed in Eurohealth are those of the authors alone and not necessarily those of LSE Health, Merck & Co and may be of significant interest to European or the European Observatory on Health Systems and countries considering how best to expand their own Policies. e-Health systems. The second describes the challenge The European Observatory on Health Systems and Policies is a partnership between the World Health Organization of introducing a case mix system to Japan, illustrating Regional Office for Europe, the Governments of Belgium, the extent to which experience in Europe has helped to Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the shape health policy in the country. Open Society Institute, the World Bank, the London School of Economics and Political Science, and the London School David McDaid Editor of Hygiene & Tropical Medicine. Sherry Merkur Deputy Editor © LSE Health 2008. No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted Philipa Mladovsky Deputy Editor in any form without prior permission from LSE Health.

Design and Production: Westminster European email: [email protected]

Printing: Optichrome Ltd

ISSN 1356-1030 Contents Eurohealth Volume 14 Number 3

Medical Devices Tit Albrecht is Researcher in Health Services, Institute of Public Health, Ljubljana, Slovenia. 1 Financing medical devices in Europe: current trends and perspectives for research Delia-Marina Alexe is Clinical Research Fellow, Health Services Research Unit, LSHTM, UK. Elio Borgonovi, Reinhard Busse, Panos Kanavos Michael Bäumler is Research Fellow, Berlin University of 4 The procurement landscape for medical devices in England: Technology, Germany. Recent developments and applications to wound care Elio Borgonovi is Professor of Public Management, Corinna Sorenson Bocconi University, Italy. 7 Financing medical devices: the case of implantable cardioverter Christine Bond is Professor of Primary Care (Pharmacy), defibrillators and coronary stents in Italy Centre of Academic Primary Care, Aberdeen, Scotland. Giulia Cappellaro, Aleksandra Torbica Reinhard Busse is Professor for Healthcare Manage- ment, Berlin University of Technology, Germany. 9 Reference pricing for outpatient medical aids in Germany Giulia Cappellaro is Research Fellow, Centre for Michael Bäumler, Jonas Schreyögg, Sabine Meissner, Research on Health and Social Care Management, Reinhard Busse Bocconi University, Italy. Michel Coleman is Professor of Epidemiology & Vital Public Health Perspectives Statistics, Health Services Research Unit, LSHTM, UK. 12 Cancer control in Europe today: challenges and policy options Kenji Fujimori is based at the Division of Medical Delia-Marina Alexe, Tit Albreht, Martin McKee, Michel Coleman Management, Hokkaido University Hospital, Japan. Kiyohide Fushimi is based at the Department of Health Health Policy Developments Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine, Japan. 16 Lampedusa and pharmaceutical distribution: community Kohichi B Ishikawa is based at the Statistics and Cancer pharmacy in the 21st century Control Division, National Cancer Center, Japan. Ricard Meneu Hideki Hashimoto is based at the Department of Health 19 The over-the-counter pharmaceutical market – policy and practice Economics and Epidemiology Research, Tokyo Christine Bond University, Japan. Panos Kanavos is Senior Lecturer in International Health 25 Development and use of the Japanese case-mix system Policy, Department of Social Policy, LSE, UK. Shinya Matsuda, Kohichi B Ishikawa, Kazuaki Kuwabara, Kazuaki Kuwabara is based at the Department of Kenji Fujimori, Kiyohide Fushimi, Hideki Hashimoto Health Care Administration and Management, Kyushu University, Japan. 30 e-Health in Canada: lessons for European health systems Denis Protti Shinya Matsuda is based at the Department of Preventive Medicine and Community Health, University of Occupational and Environmental Health, Japan. European Snapshots Martin McKee is Professor of European Public Health, 33 Assessment for reimbursement: collaboration at EU-level, the Health Services Research Unit, LSHTM, UK. MEDEV-experiment Sabine Meissner is Research Fellow, Berlin University of Ad Schuurman Technology, Germany.

34 Moldova: using social health insurance to reduce out-of-pocket Ricard Meneu is based at the Research Centre on Health and Economics, Universitat Pompeu Fabra, payments and improve equity Spain. Erica Richardson Denis Protti is Professor, School of Health Information Science, University of Victoria, Canada. Evidence-informed Decision Making Erica Richardson is Research Officer, European Obser- 36 “Risk in Perspective” Ozone and mortality – an update vatory on Health Systems and Policies, LSHTM, UK. 39 “Bandolier” Pharmacy care in older patients Jonas Schreyögg is Assistant Professor for Economics and Management of Health Technologies, Berlin University of Technology, Germany. Monitor Ad Schuurman is Head of the Reimbursement Depart- ment, Dutch Health Care Insurance Board, Amsterdam. 41 Publications Corinna Sorenson is Research Officer, LSE Health, LSE, 42 Web Watch UK. 43 News from around Europe Aleksandra Torbica is Assistant Professor in Public and Health Care Management, Bocconi University, Italy. MEDICAL DEVICES Financing medical devices in Europe: Current trends and perspectives for research

Elio Borgonovi, Reinhard Busse and Panos Kanavos

Summary: Medical technologies offer numerous benefits, in both health and economic terms. However, there is concern and a general lack of understanding about how to best realise their ultimate value, effectiveness and efficiency in health care. The establishment of the European Health Technology Institute for Socio-Economic Research (EHTI) aims to create a platform for research and debate around these key issues, bringing together academia, industry, and policy-makers. This article discusses current trends and considerations in the regulation and financing of medical devices in Europe, outlines the principal objectives of the Institute, and reflects upon the first year of research, which focused on the coverage, procurement, and reimbursement of selected medical technologies in six EU countries.

Key Words: Medical Technology, Regulation, Financing, Health Care Systems

Identifying the optimal allocation of In order to be effective, such actions applied in the pharmaceutical sector, such available resources in order to maximise should take into consideration several as reference pricing, price controls, and population health gains has been and ‘biases’ historically applied to the medical price caps, among others. continues to be a key challenge for health technology sector. The first bias concerns care systems. One of the main perceived access to innovative technologies. Earlier Medical devices and pharmaceuticals: drivers of rising health care expenditures studies in health economics in the 1950s distant cousins, not twins! has been the rapid pace of innovation in and 1960s showed that when new devices The second bias deserves particular medical technology.1 While medical tech- became widely available there was a attention. This is especially important in an nology is not always cost increasing and general overuse compared to initial calcu- era in which policy-makers have started to there are significant opportunities to lations or predictions based on approved implement measures to ensure the effec- reduce overall costs by adopting new tech- indications, suggesting potential inappro- tiveness and cost-effectiveness, often based nologies, efficiency savings are frequently priate use. These phenomena encouraged on health technology assessments (HTA), realised with a significant time lag. As notably strict policies, signalling to policy- of medical devices. HTA and related continued advances in research are makers that they should be careful in their strategies are often founded on notions of expected to produce an ever-increasing decisions regarding the financing of tech- evidence-based medicine (EBM), whereby number of alternatives for the detection, nologies, especially the most expensive. a range of evidence (for example, costs, prevention and treatment of disease, new efficacy, cost-effectiveness, equity) The second bias is related to the fact that, products will exert increasing pressure on regarding a given technology is required to date, policy measures applied to medical health care policy makers to adopt by decision-makers to support adoption. technology have been in some way measures to regulate the medical tech- However, EBM principles in general and considered similar to those pertaining to nology market with regards to access, HTA in particular, have principally pharmaceuticals. This is particularly quality and public funding. focused on pharmaceuticals. Conse- relevant to cost containment policies quently, experiences with the pharmaceu- tical sector in this regard are often Elio Borgonovi is Full Professor of Public Management, Bocconi University, Milan, Italy. considered in the development of such methods and processes for medical devices. Reinhard Busse is Professor and Department Head for Healthcare Management, and Dean of the Faculty of Economics and Management, Technische UniversitätBerlin, However, is this ‘export’ of pharmaceutical Germany. policies justified? The medical technology Panos Kanavos, is Senior Lecturer in International Health Policy, Department of Social industry is largely, if not completely, Policy and Merck Fellow in Pharmaceutical Economics at LSE Health, London School of different from drugs. There are several Economics and Political Science, United Kingdom. Email: [email protected] reasons for this departure. First, in terms

1 Eurohealth Vol 14 No 3 MEDICAL DEVICES of its structure, the medical technology their performance and safety. Moreover, innovative model with several tangible industry is much more fragmented. Even medical devices often require ‘lead users’ advantages, including: (1) creation of though there are big multi-national for their success (for example, operating synergistic effects between all partners corporations, there are many more equipment needs to be accepted and used participating in the research process, (2) medium and small companies in operation by certain surgeons); the partnership consideration of policy-makers’ needs and, and it is true that the development of new between technology producers/suppliers (3) generation of evidence based on robust medical devices frequently takes place in and health service delivery organisations methodology that may be useful to smaller entrepreneurial companies. This assumes an integral role in this process. multiple stakeholders and the research may be a reflection of differences in the community. The Institute aims to become Fourth, and building upon the previous two industries in terms of risk perception one of the principal actors in the European points, a further important difference and regulations, particularly in connection health policy arena, leading the debate between pharmaceuticals and devices lies with the clinical development programme around key issues affecting the viability in the ability and propensity to make (extent, uncertainty and intensity of and sustainability of the medical tech- changes in the device product during financial resources) in the pharmaceutical nology sector and its link to societal health clinical evaluation and after it has been sector compared with medical devices. and wealth.4 In this respect, it also aims to marketed.2 A pharmaceutical product is fill an important gap relating to the under- Second, the significance of patents as usually in its completed form prior to standing of medical technology, the impor- incentives for innovation is influenced by marketing and is described by its chemical tance of R&D and the benefits accruing to the different nature of Research and Devel- formula; in most cases, dosage remains both patients and society. opment (R&D) in the pharmaceutical and stable during the life of the product. In medical device industries.2 In pharmaceu- contrast, devices are constantly being Research objectives ticals, it is very difficult to design a modified to remove defects, improve From a research perspective, EHTI focuses molecule that simulates all the efficacies performance and add features throughout on conducting and supporting high- and side effects of another drug; even if this the product lifecycle. These changes occur quality empirical research on a range of were possible, patentability for two frequently and fuel competition among topics relevant to medical technology, virtually identical molecules would be manufacturers, with a view to offering including the value of innovation, quality nearly impossible. However, this is not the better product performance and features. of life, quality of care, productivity, case with medical devices. A further As a result of the continuous product financing and reimbursement. In the first difference between drug and medical changes that devices undergo, as well as the year of activity, the three universities have device patents lies in which aspects of the differences in the R&D process, it is hardly focused their research on the financing innovation lead to patentable claims. In surprising that the product life cycle in the mechanisms for, and access to, medical medical devices, the basic principle can be medical device industry is much shorter technology in European countries. patentable, but specific devices usually are than that in the pharmaceutical industry, not. In the pharmaceutical industry, it is Regulatory policies in general, and rendering individual medical devices often just the opposite. Generally financing measures in particular, are obsolete within a few years, compared speaking, it is possible to design a new considered important factors impacting on with the statutory patent term (twenty device for a specific application in a the availability of, and access to, medical years) and marketing exclusivity periods number of different ways. The innovation devices. It is therefore essential to address (up to ten years) that apply to pharmaceu- often lies in the underlying principle being the issue of how medical devices are ticals. For all of the above, there are good used in the particular application. currently regulated and financed across reasons to believe that the ‘regulatory different health care settings in Europe, as Third, the innovation process differs approach’ applied to the medical tech- well as understanding who benefits from significantly between pharmaceuticals and nology sector should be different from that investments in medical technology. To that medical devices. For the pharmaceutical employed in the pharmaceutical sector. end, the ultimate aim is to provide industry, the key issue is to discover a High-quality scientific research on the systematic, comparative evidence on molecule that, when demonstrated effects of policy instruments transferred regulatory policies across countries and effective for a certain illness, may immedi- from the pharmaceutical sector will technologies and to generate data on the ately become a blockbuster in terms of the provide the necessary evidence to policy impact of adopted policies in terms of return on investments made. The R&D makers to understand relevant differences. technology uptake and diffusion. This process is very long (approximately twelve research fulfils an important role as the years), with the overall costs reaching The European Health Technology Institute existing literature has not yet sufficiently several hundred million euros per for Socio-Economic Research addressed these issues in a systematic way. marketed drug. The ‘me too’ phenomenon Based on this rationale, the European (i.e. the marketing of drugs with slightly Health Technology Institute for Socio- Since the early 1990s, market access for modified molecules, but similar effec- Economic Research (EHTI) was estab- medical devices in Europe has been regu- tiveness), is present but, in general, it has lished in 2007.3 The idea of the EHTI was lated through several EU directives. These limited effects on product development or based on the aim of forming a collaborative directives must be transposed into national within-product differentiation. By network of highly reputable academic law in each EU Member State. The EU contrast, the innovation process for institutions, Bocconi University (BU), directives specify the conditions that a medical technology is incremental. Milan, Technical University (TU) of product must meet in order to obtain the Although there are some cases of break- Berlin, London School of Economics and CE mark. With the CE mark a product through innovation, it is more typical to Political Science (LSE), industry and the may be marketed in all EU Member States. iteratively improve existing products in policy-making community. This is an The directives speed up the adoption

Eurohealth Vol 14 No 3 2 MEDICAL DEVICES process per se and, at the same time, frequently the inclusion has been updated from medical technology and that this provide a uniform definition for medical following progress with the technology. health gain is translated into economic devices in the European Union. Against societal gain.7 While it is clear that Financing mechanisms were analysed this background of European regulation, innovation, in general, contributes to along two distinct dimensions: procure- actual adoption and use in individual economic development and welfare ment and reimbursement. Procurement is Member States depends mainly on improvements, the process whereby concerned with the ‘price’ of technologies whether the medical devices are covered technological innovation in medical established between the producers and by the (public) benefit baskets and how technologies leads to growth and welfare providers of health care services (mainly in financial arrangements provide incentives gains is not well understood and would the cases of 2 and 3 above) and the main (or otherwise) for their use. benefit from empirical research. Indeed, areas of investigation were: level of price the social and economic value of medical Therefore, initial research by EHTI setting and negotiation (centralised vs. technology is the current focus of a second focused on key issues relating to (a) decentralised procurement); existence of stream of research carried out by BU, the coverage, (b) procurement and (c) reim- ‘reference’ prices to be used in tender LSE and TU Berlin and which, in its initial negotiations; and criteria used in price bursement of selected medical technologies phase, is aiming to produce a review based in six EU countries (Germany, Poland, negotiation. Finally, analysis of reim- on published and unpublished studies and Italy, Spain, the UK and France), repre- bursement systems across countries reports made available within Europe and senting both the largest countries and a examined different funding systems (tariff- elsewhere in recent years. mixture of North and South, tax-financed based versus global budgets) and the and insurance-based, decentralised and decision-making actors and level(s) at It is hoped that EHTI’s research will centralised systems. The technologies which funding is established (national expand the existing knowledge base examined were knee endoprostheses, versus regional level). regarding the effective uptake and use of, as implantable cardiac defibrillators (ICDs), well as access to, medical technologies. coronary stents, laparoscopic colorectal Results Further, through its efforts, it is hoped that surgery, urinary incontinence pads and new The accompanying country case study stakeholders – academia, industry, and wound care products (for example, articles present some of the results obtained policy-makers – will collaboratively engage negative pressure therapy). in this phase of research. One examines the in debate and discussion on the key issues financing of ICDs and coronary stents in highlighted throughout this article. Indeed, The technologies were selected to Italy, while another explores recent devel- the unique contributions of medical represent three sets of principle markets opments in the procurement landscape for devices, in both health and economic terms, for medical devices: medical devices in the UK, with a focus on need to be further understood, with the 1. Medical aids which are mainly given to their applications to wound care. Finally, ultimate aim of improving patient lives and and used by patients directly, (for example, the use of reference pricing – a typical supporting continued medical innovation. incontinence products). These tech- instrument taken from pharmaceutical nologies potentially constitute health care policies – is assessed for outpatient medical benefits in their own right; aids in Germany. REFERENCES 1. Fuchs V, Sox H. Physicians’ views of the 2. Medical devices which need to be Conclusions and next steps relative importance of thirty medical inno- implanted into a patient (for example, Technological innovation is perceived to vations. Health Affairs 2001;20(5):30–42. stents, ICDs, or endoprostheses). These be at the root of the recent cost escalation 2. Gelijns AC, Halm EA (eds). The technologies entail only one component of in health care. However, existing evidence Changing Economics of Medical health care benefit (with hospital or ambu- suggests that, on average, increases in Technology. Washington DC: National latory services making up the other medical spending since 1960 and develop- Academy Press, 1991. components); and ments in technology have provided value, 3. The European Health Technology 3. Medical devices which are used to leading to significant improvements in Institute for Socio-Economic Research provide services by physicians or other patients’ quality of life, and reductions in (EHTI) (2007). Available at health care providers (for example, laparo- disability levels and mortality rates.5,6 Yet, http://www.together4healthinnovation.eu scopic procedures). These are technologies such benefits and the beneficiaries of tech- 4. Suhrcke M, McKee M, Sauto Arce R, where the service, not the device, repre- nological innovation, most notably in Tsolova S, Mortensen J. The Contribution sents the health care benefit. relation to medical devices, have not been of Health to the Economy in the European adequately studied. As a result, evidence is This distinction was developed in order to Union. Brussels: Commission of the needed to demonstrate the numerous European Communities, 2005. analyse the key issues of coverage, benefits arising from investments in procurement and reimbursement of 5. Cutler DM, Rosen A, Vijan S. The value medical technology and, in parallel, how devices beyond the peculiarities of the six of medical spending in the United States, the dynamics of coverage, procurement, technologies. In terms of coverage, several 1960–2000. New England Journal of reimbursement, and diffusion of medical issues were investigated: whether the tech- Medicine 2006:355;920-927. technology operate across different health nology was explicitly included in the 6. Cutler DM. The lifetime costs and systems and regulatory environments. national/regional benefit basket or benefits of medical technology. Journal of statutory insurance schemes; the main With regards to the beneficiaries of Health Economics 2007;26(6):1081–100. decision criteria for the inclusion/ medical technologies, it is important to 7. Gandjour A. The economic value of exclusion of the technology – separately or bear in mind that a wider group, beyond medical technology. Health Affairs as part of a broader service; and, if and how patients or health professionals, benefit 2002;21(1):275–76.

3 Eurohealth Vol 14 No 3 MEDICAL DEVICES The procurement landscape for medical devices in England:

Recent developments and applications to wound care

Corinna Sorenson

Summary: The process by which the English National Health Service (NHS) purchases and introduces innovation into its system of hospitals and general practitioner practices is crucial to realising the numerous benefits afforded by medical technologies. Several actions have recently been instituted into the procurement landscape for medical devices in England, including development of collaborative ‘procurement hubs’, National Contracts Procurement and reor- ganisation of the roles of key purchasing bodies, all principally under the auspices of the Supply Chain Excellence Programme. While most of these initiatives generally focus(ed) on short-term cost containment and efficacy gains, it has been argued that procurement decisions and practices should be increasingly grounded in providing greatest benefits to patients and providing the best value for money for the £15 billion spent each year by the NHS on goods and services.

Key words: Health Care Financing, Medical Devices, England, Wound Care

Numerous programme and policy initia- collaborative ‘procurement hubs’, cheaper and often older equipment from tives have been introduced in England National Contracts Procurement (NCP), large suppliers, who can more easily since the late 1990s to support the effective and reorganisation of the role of the NHS accommodate NHS demands for low use of National Health Service (NHS) Purchasing and Supply Agency (PaSA). prices and high volume. This can provide funding in providing accessible and inno- The latter now has responsibility for disincentives for innovative products to be vative health care. As the 2002 Wanless device evaluation and outsourcing of NHS developed and available to patients and Report1 highlighted, investments in inno- Logistics – a ‘joined-up’ effort deemed the providers, in addition to disproportion- vative medical technology are an important NHS Supply Chain, which serves as the ately orienting objectives towards short- component of NHS planning to maintain primary purchasing agent for the NHS. term cost-savings, rather than long-term an efficient and high-quality health service Other changes to the governance structure benefits and costs.3 While cost and drive socioeconomic benefits. Conse- were realised, with the multi-national containment is certainly a key objective of quently, the process by which the NHS company, DHL, and US-based purchasing any health care system, procurement deci- purchases and introduces innovation into organisation, Novation, overseeing oper- sions and practices should be grounded in its system of hospitals and GP practices is ation of the Supply Chain, in collaboration providing greatest benefits to patients and crucial to realising the numerous benefits with the NHS Business Services Authority providing the best value for money for the afforded by medical technologies. (NHSBSA). The SCEP was recently £15 billion spent each year by the NHS on In particular, several actions have been succeeded by the NHS Sourcing and goods and services. recently instituted into the procurement Supply Chain Improvement Programme landscape for medical devices in the NHS. (NSSCIP), which aims to continue many Evidence-based purchasing Such change was arguably first initiated by of the SCEP’s key objectives (for example, To help meet this objective, recent changes 2 the development of the Supply Chain use of purchasing hubs). encompassed the development of a new Excellence Programme (SCEP), which The legacy of SCEP and associated devel- device evaluation service, the Centre for sought to improve methods of both opments on NHS procurement is Evidence-Based Purchasing (CEP), within national and regional procurement uncertain. With a greater commercial NHS PaSA. The Centre was established to through various mechanisms, such as orientation, the Programme increased the provide evidence to underpin purchasing focus on bulk purchasing and a compet- decisions and, more broadly, to support Corinna Sorenson is Research Officer, itive tendering process. While such prac- the uptake of effective, safe and innovative LSE Health, London School of Economics tices can have positive implications for products and related procedures in health and Political Science, UK. efficiency gains and reduced prices, this care. While evaluation of medical tech- Email: [email protected] has lead, in some cases, to the purchase of nology has historically rested on evidence

Eurohealth Vol 14 No 3 4 MEDICAL DEVICES

Figure 1: Procurement mapping of Vacuum Assisted Closure (VAC) therapy

Collaborative ABHI Manufacturer Procurement Hub

Evaluation Centre NHS Supply Chain

Acute Trust/Hospital Wound Healing General Various & Service Consultants Head of Director Research specialist Managers Procurement of Nursing Unit nurses

Patient DOH

PaSA SHA PCT Royal College of Nursing CEP NICE District Nurse

of performance and safety, the CEP and its account for the incremental development collection canisters, connection tubes and programmes, such as the Multidisciplinary of most medical technologies. Indeed, specialised dressings to drain wounds of Assessment of Technology Centre for devices are typically developed through a exudate (i.e. excess fluid and cells) and Healthcare (MATCH)* , aim to incor- dynamic, iterative process, whereby their influence growth of surface tissues. To porate considerations of costs, patient functionality is constantly improved upon date, VAC therapy is primarily used for outcomes and clinical opinion into a by user feedback and further research. This acute (e.g. skin grafts) and chronic (e.g. leg procurement framework. As promulgated results in the evolution of new generations ulcers) wounds of variable size and by these initiatives, such evidence could be of the initial device, leading to different complexity, and is employed in both used to inform procurement contract characteristics, outcomes and cost hospital and community care settings. agreements and determine appropriate estimates with each progressive iteration. While still an early product, the benefits of pricing bands for applicable tariffs. To this point, evaluation prior to VAC therapy for wound care patients are considered high, in terms of wound While the principal objectives of evidence- procurement, either at first generation or healing, cost-effectiveness, and reduced based purchasing (EBP) are laudable and before user feedback can be assessed, may length of stay. Currently in the NHS, increasingly needed to support value for not fully or accurately capture the true purchasing activity for VAC therapy is money in the NHS, it is still in an value of a given technology. predominated by NHS Trusts (devices) embryonic stage of development. and the NHS Supply Chain (consum- Moreover, similar to other procurement Application to wound care ables). Procurement decisions are developments, EBP presents challenges for Recent innovations in wound care, partic- primarily comprised of two main choices, highly innovative or new technologies in ularly Vacuum-Assisted Closure (VAC) purchase or rent, which is mainly deter- the early stages of commercialisation. In therapy**, provide a helpful example to mined by specialist nurses and clinicians. particular, the data or evidence required for illustrate some of the opportunities and Figure 1 maps the procurement landscape the evaluation of medical devices are often challenges associated with application of related to VAC therapy. unavailable, as unlike pharmaceuticals, EBP in the NHS. VAC therapy is a rela- randomised controlled trials are not tively immature and highly innovative Increased demand and its innovative required for market approval. Even in cases intervention that applies negative pressure nature have placed VAC therapy on the where data are available for early evalu- to accelerate wound healing. It employs procurement agenda in the NHS. ation, evidence is unlikely to appropriately electrically-powered vacuum pumps, However, decision-makers are often

*The MATCH programme constitutes a research collaboration between various UK academic institutions and a group of industry partners. Beyond its scientific aims, MATCH seeks to strengthen key networks and engagement between regulators, industry, and patients – all with their own important perspectives regarding medical technologies. ** Included in general category of Negative Pressure Therapy for wound care.

5 Eurohealth Vol 14 No 3 MEDICAL DEVICES grounding purchasing activity on mixed or perspectives, in addition to pure cost- be upheld. As NHS procurement assumes limited evidence. This is principally due to minimisation considerations, which a commercial element and often involves a considerations regarding data availability currently tend to dominate purchasing vast array of transactions, an open process for new and notably innovative therapies decision-making. In particular, stake- is necessitated. and, perhaps, as a result of insufficient holders both inside and outside the NHS The procurement landscape in England has resources allocated to adequately assess the could contribute input regarding how: undergone notable transformations, intro- existing evidence on the costs and benefits (a) different elements of procurement ducing various policies and mechanisms to of VAC therapy. Wound care itself also interact, (b) patient needs can be achieved, enhance the value for money achieved in introduces challenges that can impact on (c) innovation can be better integrated into NHS purchasing. EBP, marked by the their evaluation and, subsequently, EBP. the NHS, and (d) industry can be establishment of the CEP, is one particular For instance, wound care is highly variable rewarded for high-value products. In strategy to meet this aim. While EBP may across wound type and characteristics, terms of NICE in particular, it will prove help shift focus from short-term gains to frequency of dressing changes and important to carefully assess how sustainable cost and outcomes in NHS duration of treatment. Moreover, there are evidence-based purchasing decisions (and, purchasing, adequately accounting for few ‘standard’ or ‘conventional’ products evaluative processes) may coincide with innovation and differences between tech- in this therapeutic area, as evidenced by the the Institute’s decisions and guidance. The nologies (i.e. devices vs. pharmaceuticals) variety of innovative wound treatments on information provided through interactive in its practices and methods is crucial. the market and the presence of inconsistent and iterative communication routes facili- Furthermore, requisite resources should be local clinical guidelines on use in patient tates parallel benefits for improved invested in the CEP to ensure an effective care. purchasing decisions, continuous device and robust process and, importantly, one development and enhanced management with an impact on procurement. Indeed, Outstanding issues of wound care in the NHS. purchasing practices and policies should In order to address some of the issues Thirdly, as the concept and use of EBP ultimately support the founding principles related to VAC therapy and facilitate the develops in England, the unique consider- of the NHS – providing patients with effective use of EBP, especially in highly ations of innovative devices must be taken high-quality, effective, and affordable innovative therapies, there are a number of into account, many of which have been health care. outstanding issues that need to be highlighted throughout this article. These addressed. Firstly, systematic review of include, but are not limited to, the method- available evidence and/or economic ological challenges associated with early REFERENCES analyses, including modelling, needs to be evidence and technologies intended for pursued. Given it is a fairly immature 1. Wanless D. Securing Our Future Health: small patient populations; the iterative therapy, there may be limited data and, Taking A Long-Term View. London: The development curve; and the high cost and Stationery Office, 2002. Available at where evidence is available, methodological resource needs of distribution and user http://www.hm-treasury.gov.uk/ issues (for example, small sample sizes, training and education. To that end, Consultations_and_Legislation/wanless/ variation in outcome measurement) may be devices, as compared to pharmaceuticals, consult_wanless_final.cfm present. This may be exacerbated by the require a significant level of user lack of clarification as to what constitutes 2. NHS Purchasing and Supply Agency. involvement, which ultimately has impli- standard wound care. Such challenges must Business Plan 2007/2008. Reading: NHS cations for the performance (i.e. effec- be acknowledged and addressed through PaSa. Available at tiveness, safety) of the product. The http://www.pasa.nhs.uk/PASAWeb/ additional evidence and consideration of medical technology industry is typified by NHSprocurement/AboutNHSPASA/ new data as it becomes available. MATCH small companies, who may lack the Publications/Corporatepublications.htm is addressing some of these methodological necessary resources to amass the infor- issues by incorporating different analytical 3. Department of Trade and Industry. mation required by CEP or other relevant approaches, for example, Bayesian tech- Competing in the Global Economy: The EBP bodies. Fourthly, similar to any eval- niques, into value-assessment methods for Innovation Challenge. DTI: Innovation uative process for determining the value of Report. London: Department of Trade and the purposes of procurement. new health technologies, the transparency Industry. Available at: Secondly, as demonstrated by the example of EBP-based procurement decisions must http://www.berr.gov.uk/files/file12093.pdf of VAC therapy, there are a vast range of actors involved in the procurement Conference: Bridging Knowledge in Long Term Care and Support process. To ensure national and local rele- vance and cross-stakeholder engagement, La Pedrera de Caixa Catalunya, Barcelona 5–7 March 2009 collaboration is needed amongst key stake- In Europe over 15 million people with disabilities will soon enter old age, while a similar holders, including industry, the Associ- number of older people will become disabled. This conference will explore methods and ation of British Healthcare Industries systems for long-term care and support, in particular looking at how to integrate and (ABHI), the Department of Health transfer knowledge and experience between the ageing and disability sectors. (including the National Institute for Health and Clinical Excellence – NICE), Supported by the European Commission, it will feature a mix of keynote speeches by procurement actors (for example, collabo- international experts and parallel symposia. rative procurement hubs, Trust Managers, Early registration closes on 15 December 2008. Further information on the conference Directors of Nursing) and users of the programme, abstract submission and registration at: technology. These key stakeholders should http://obrasocial.caixacatalunya.es/osocial/main.html?idioma=3 be involved in lending valuable multiple

Eurohealth Vol 14 No 3 6 MEDICAL DEVICES Financing medical devices: The case of implantable cardioverter defibrillators and coronary stents in Italy

Giulia Cappellaro and Aleksandra Torbica

Summary: In the recent years, the financing of medical devices has gained increasing attention from health policy makers in Italy at both regional and national level. The article investigates the current modalities of procurement and reimbursement of cardiovascular medical devices in Italy, as well as their diffusion across the country. Both implantable cardioverter defibril- lators and coronary stents are purchased by health care providers through open public tenders and are prospectively reimbursed using Diagnosis Related Group tariffs. Empirical data suggest that these technologies have increasingly been used in recent years in Italy.

Key words: Health Care Financing, Medical Devices, Reimbursement, Italy

The financing of medical devices has only between 2002 and 2008, three merit special and reimbursement of medical devices in become an important agenda item for attention: the creation of the Medical Italy. To achieve this we focus on two tech- Italian health policy makers in the last few Devices Committee, the development of a nologies: implantable-cardioverter defib- years. In fact, with the exception of several national database of medical devices and rillators (ICDs), used for the prevention of laws adopted to simply transpose EU the implementation of a system of sudden death due to arrhythmia in patients directives on market access regulation, no reference pricing. The 2003 Financing Law with acute myocardial infarctions, and significant policy measures were taken established the Medical Devices coronary stents used in percutaneous until 2002. The main reason for the Committee (Commissione Unica sui coronary interventions (PCI) for patients increased attention is undoubtedly linked Dispositivi Medici-CUD). Its main objec- with ischemic hearth disease. The to the economic and financial sustain- tives were to create a national database of prevention and treatment of cardiovascular ability of the system. Medical device medical devices currently available on the diseases is the most important clinical area expenditure accounts for almost 6% of market (Repertorio Nazionale) and to to consider, both in terms of impact on overall health care expenditure in Italy, or subsequently update this on a regular basis overall health care expenditure and the rate around € 4 billion per annum.1 Further- taking account of clinical and economic of innovation in medical devices used for more, the rapid pace of innovation in this criteria. This national database became treatment and diagnosis. area has raised the level of debate over the functional in May 2007 and, from January best ways in which to guarantee equal 2009, only devices described therein may Diffusion of ICDs and coronary stents access to new medical devices and at the be purchased, used or distributed within Empirical data suggest that the use of both same time ensure the long-term financial the Italian NHS. The 2007 Financing Law of these technologies has significantly sustainability of the Italian National also introduced reference prices for a list increased in recent years. The recently Health Service (NHS). of selected medical devices that should be established National Registry for ICDs used in procurement arrangements revealed that approximately 10,400 ICDS Among several policy measures adopted between medical device producers and were implanted in 2005, almost 60% more health service providers. A Ministerial than in 2004.2 This equates of a ratio of 179 Decree on 11 October 2007 defined the implants per million population; across Giulia Cappellaro is Research Fellow at first medical devices to be affected by Europe this ranges from 67 per million in the Centre for Research on Health and reference pricing and includes, for Portugal to 262 per million population in Social Care Management, Bocconi example, coronary stents and hip endo- University, Milan, Italy. Aleksandra Germany.3 The significant increase in Italy prostheses components. Torbica, is Assistant Professor in Public should be interpreted with caution due to and Health Care Management, Bocconi Following this short overview of recent differences in data. It can only partially be University, Milan, Italy. policy measures, we now investigate explained by the larger use of ICDs in Email: [email protected] current procedures for the procurement primary prevention. Different types of

7 Eurohealth Vol 14 No 3 MEDICAL DEVICES

Figure 1: Diffusion of PCI procedures and coronary stents in Italy Before the recent introduction of reference prices, aimed to put a cap on the cost of bids in public tenders, price negotiations 140,000 100% were free. Even though both technologies, 98% ICDS and stents, will eventually be 120,000 affected by this measure, only coronary 96% stents were included in the initial list of 100,000 94% devices with reference prices (Table 1). 92% 80,000 Total PCI Reimbursement measures 90% In Italy, given that all medical devices are 60,000 88% implanted on an inpatient basis, ICDs and PCI with stent stents are prospectively reimbursed 40,000 86% through DRG tariffs. From 1 January 2006 84% 20,000 a new DRG classification system (Grouper % PCI with stent / total PCI 82% 19) was adopted nationwide. This change 0 80% has influenced the reimbursement of both 2001 2002 2003 2004 2005 2006 ICDs and coronary stents, since it defined three new DRGs specific to these devices. ICDs are currently reimbursed through Source: Calculations, based on data of GISE (www.gise.it) DRGs 514 and 515 – cardiac defibrillator implant with/without cardiac catheteri- Table 1: Reference prices for coronary stents sation. Coronary stents are included in DRG 517 – percutaneous interventions for Description Technical specification Reference price (€) the cardiovascular system with insertion of stent in the coronary artery without acute Bare metal stents Stainless steel 505 myocardial infarction. The different Italian regions are entitled to Bare metal stents Chrome or cobalt-chrome 572 adopt different policy measures to regulate reimbursement mechanisms for medical Covered coronary stents Carbon 557 devices.5 The variability of regional reim- bursement systems plays a significant role Drug eluting coronary stents – 1,486 in the use of cardiovascular implantable technologies. Some regions reimburse a Source: Ministerial Decree 11 October 2007 percentage of the cost of the device ICDs can be used, they can vary by the are several types of stents, for example, (Lombardy, for instance, recognises 30% type of pulse generators they use. Looking drug eluting stents (DES) and bare metal of the average weighted regional costs of at first implants and replacement interven- stents (BMS). DES now account for 56% BMS and 50% of DES), whereas other tions triple chamber ICDs account for of all stent procedures compared with 18% regions, mainly Campania or Sardinia, 37% of all implantations compared to 32% in 2003 when they were first introduced provide a fixed top-up to DRG tariffs for using double chamber and 30% single onto the Italian market. devices. chamber ICDs. Procurement – financial arrangements Discussion and future perspectives Turning to coronary stents, data on activity between producers and providers In recent years, the financing of medical in catheter laboratories in Italy4 highlight Both ICDs and stents are purchased by devices has gained increasing attention the significant increase in the total number health care providers through open public from health policy makers in Italy at both of PCI procedures from approximately tenders. Negotiations take place at regional and national level. From the 65,000 in 2001 to 125,000 in 2006 (Figure provider level, even though centralised measures adopted, it appears that national 1). This increase can partially be explained procurement strategies have been enacted policy makers have focused their attention by improvements in both diagnostic and at both regional and inter provincial level. on cost containment policies by estab- therapeutic procedures that have expanded Public tenders are usually assessed on the lishing the maximum prices for devices the number of patients eligible for the basis of cost, with the price/quality criteria that can be used in tender negotiations. It procedure. Technological innovation (i.e. ratio varying from 40/60 to 50/50. Given is still too early, however, to quantify the the introduction of coronary stents) is the rapid pace of innovation in this effects of the introduction of national undoubtedly one key factor. In fact, the category of devices, quality criteria are reference prices in Italy. Furthermore, the increase in PCI procedures with coronary usually based not only on the technical government has recently recognised the stents has grown faster than the number of evaluation of the device, but also on the temporary nature of reference prices and total PCIs (with and without stents) during results of clinical studies, research and the need to identify complementary cost- the same period increasing from 81.6% of development programmes and, in case of containment alternatives; nevertheless no all PCIs (53,411 procedures) in 2001 to selected innovative products, the quality of official policy measures have, to date, been 92.5% in 2006 (114,799 procedures). There samples provided by the manufacturer. adopted.

Eurohealth Vol 14 No 3 8 MEDICAL DEVICES

The regional health authorities, on the other hand, have mainly concentrated on Reference pricing for defining different reimbursement policies to control costs. Even though significant progress has been made, the current clas- outpatient medical aids in sification system does not allow for differ- entiation between types of ICD or coronary stent. This could potentially Germany hinder the diffusion of innovative devices. Data highlight regional variability in the diffusion of both technologies, but the hypothesis that this is due to different reimbursement schemes still needs to be Michael Bäumler, Jonas Schreyögg, Sabine Meissner and tested empirically. Reinhard Busse Given the increasing attention of Italian policy makers to the definition of policies in the medical device sector, new measures Summary: German reference prices define a limit for reimbursement by sickness are likely to follow. The effectiveness of funds for certain categories of products. In 2005 a nationwide reference price these policies will greatly depend on the system for six of thirty-three categories of medical aids was introduced. Prior to success of coordination between the this, reference prices had only existed for these categories in some of the German national government and the regions, since Länder. A data sample provided by a large German sickness fund indicated the major critical feature of the Italian decreasing expenditure in five categories after the introduction of the new system NHS remains the distribution of powers while expenditures for one category increased. However, a judgement on the between the two levels. efficacy of reference prices seems to be difficult as there were both different starting points for reference prices in the Länder and other factors influencing expenditure.

REFERENCES Keywords: Reference Prices; Medical Aids; Germany; Expenditure 1. Directorate General for Drugs and Medical Devices. Dispositivi Medici. Aspetti Regolatori e Operativi [Medical Devices: Contributions to German Social Health patients), as the ‘sector’ medical aids and Regulatory and Operational Factors].A Insurance (SHI) are paid in equal part by ‘services by non-physicians’ (for example, cura della Direzione generale dei Farmaci e employers and employees as a proportion physiotherapy) was one of the few Dispositivi Medici del Ministero della of salary. As the employers’ payments are remaining sectors with visible expenditure Salute. Rome: Ministry of Health, 2007. thought to be one of the reasons for high increases – nota bene, in official statistics 2. Associazione Italiana di Aritmologia e unemployment rates in Germany, on SHI expenditure, the two groups are Cardiostimolazione. Registro Italiano Pace- endeavours to lower these costs, or at least always given together so that the overall maker e Defibrillatori. Bollettino Periodico to fix them at their current level, have been development was extrapolated to both. made. In the ambulatory and hospital care 2005. [Italian Registry of Pacemakers and We aimed to analyse if there is evidence sectors, expenditures have generally been Defibrillators. Bulletin 2005] Giornale that the introduction of nationwide Italiano di Artimologia e Cardiostimo- contained by tying changes in reim- reference prices for certain groups of lazione 2006;9(3). bursement to changes in contributory medical devices led to decreasing SHI income. For the cost containment of phar- 3. Peinado R, Torrecilla E, Ormaetxe J, expenditure, in comparison to what maceutical expenditure, a range of more Alvarez M. Registro Espanol de desfibri- happened in the pharmaceutical market and less successful instruments, including lador automatico implantable. III Informe where we judged this to be quite regional and physician-specific prescrip- Oficial del Grupo de Trabajo de Desfibri- successful.1 To do this we examined a tion caps as well as reference prices (since lador Automatico Implantable de la sample of administrative data on spending 1989), have been used. Sociedad Espanola de Cardiologia. [Spanish on medical aids.2–5 of the Gmünder ICD Registry. Third official report of the Thus, the temptation was great to also use ErsatzKasse (GEK). This is one of Spanish Society of Cardiology Working this reimbursement system in the market Germany’s largest sickness funds which Group on ICDs]. Revista Espanola de for medical aids (i.e. medical devices insures about 1.65 million people. Cardiologia 2006;60(12):1290–301. prescribed in ambulatory care for use by 4. Societa Italiana di Cardiologia Invasiva. Definition of reference prices in Attività dei Laboratori Italiani di Emodi- Germany namica. I dati delle attività – 2003, 2004, Michael Bäumler and Sabine Meissner are The German reference price system does 2005, 2006. [Annual activity of Italian Research Fellows, Jonas Schreyögg is not set fixed prices but instead limits what hemodynamic laboratories 2003–2006] Assistant Professor for Economics and may be reimbursed by the sickness funds. Available at http://www.gise.it/ Management of Health Technologies and For products with prices higher than the Reinhard Busse is Professor for Health 5. Fattore G, Torbica, A. Inpatient reim- reference price, the insured individual has Care Management all based at Berlin bursement system in Italy: how do tariffs to pay the difference between the reference University of Technology, Germany. relate to costs? Health Care Management price and the price set for manufacturer/ Science 2006;9:251–58. Email: [email protected] distributor reimbursement. The reference

9 Eurohealth Vol 14 No 3 MEDICAL DEVICES prices include value added tax and all costs representing people with disabilities then (Table 1). In contrast, while expenditure on arising from the delivery of medical aids. have the opportunity to issue statements other medical aids not falling under the that have to be taken in consideration in reference price scheme decreased between Reference prices for medical devices the process of grouping aids for reference 2003 and 2004, it again increased in 2005. demand the same requirements as pharma- pricing and in the process of setting price As Figure 1 illustrates while there was a fall ceuticals. They have to guarantee a suffi- levels. These reference prices are then in 2006, this group continued to have cient, appropriate and efficient, as well as assessed at least once a year and adjusted higher levels of per capita expenditure quality-assured provision of medical as appropriate to take account of market compared with medical aids in the devices. Reference prices aim in principle conditions.8 It is important to note that reference pricing groups. to mobilise efficiency reserves and stim- categories may encompass a large number ulate effective price competition. of product groups, i.e. a reference price is Conclusion and perspectives Therefore, the price should preferably be not set for a whole category but for each It is difficult to judge the success of the orientated towards reasonably priced individual product group: for example, introduction of nationwide reference goods and services. Sickness funds are ostomy currently encompass thirty-one pricing in Germany, since (1) results are requested to make use of public tenders in product groups, with reference prices not unambiguous, (2) the number of respect of medical devices that are not ranging from €111.47 to just €0.04. prescribed medical aids switches between subject to reference-pricing. products within a group, and actual prices Impact are currently impossible to disentangle and Introduction of reference prices for Figure 1 illustrates relative expenditure per therefore (3) it is not possible to medical devices insured person in the GEK between 2003 adequately assess the impact on issues such Reference prices for medical devices were and 2006 inclusive, i.e. before and after as patients’ equity of access, appropri- first established under the 1989 Health nation-wide reference prices were intro- ateness and quality of care and the level of Care Reform Act.6 Visual and hearing aids duced in 2005, with 2004 as the index year. innovation of the industry. We therefore were reference-priced in all federal states These expenditures decreased dramatically concentrate on expenditure per capita data. (Länder), whereas devices for decubitus, from €9.27 per insured individual in 2003 arch supports, incontinence aids and With the exception of incontinence and €3.81 in 2004 to only €0.91 and €0.81 ostomy procedures only received reference products, expenditure per capita decreased in 2005 and 2006 respectively. prices in some of them. The prices itself for all categories of medical aid with a were defined by the different regional The expenditures for all categories with reference price. The greatest fall in expen- associations of the sickness funds.7 reference prices (with the exception of diture was observed in those categories of visual aids which are not included in the medical aid that had rarely made prior use When the SHI Modernisation Act (GMG) analysis as reference pricing already existed of reference pricing. In the case of hearing came into effect in 2004, the federal associ- on a nationwide basis) increased in 2004 by aids, where reference pricing had existed ations of the sickness funds were required between 10% (hearing aids) and 5% (arch before 2005, only a small decrease in to set nationwide reference prices for the supports). After the introduction of expenditures could be observed. first time. The first came into effect on 1 reference prices, expenditure fell both in January 2005 for the following six (of a Compared with all non reference-price 2005 and 2006, save for incontinence aids, total of thirty-three) categories of the categories, which increased after 2004, it is a category for which reference prices were medical aids catalogue: arch supports, tech- striking that expenditures for categories initially not set for all product groups nical aids for compression therapy, visual grouped using reference prices decreased and hearing aids, absorbing and draining incontinence aids and ostomy procedures. Figure 1: Expenditures per insured per year (with expenditures for 2004 as the index year)

The setting of reference prices In a first step, reference price groups are formed by the federal associations of sickness funds for products of homoge- neous and equivalent functionality on the basis of the classification of the respective product groups within each category in the catalogue of medical aids.6 This is clearly an important precondition as groups with heterogeneous products of different func- tionality would have a clear potential for inappropriately steering the usage of one product over the other. Forming groups with the aim of calculating reference prices is therefore confined to groups where homogeneity can be reasonably safely evaluated or assumed. In a second step, reference prices are set for each group by the associations of sickness funds. Manufacturers and organisations Source: Calculations, based on data of GEK Heil- und Hilfsmittelreport 2004–2007.2–5

Eurohealth Vol 14 No 3 10 MEDICAL DEVICES

Table 1: Overview of changes in expenditure for different categories of medical aids

Category Expenditure per insured % of total expenditure for Reference prices Expenditure Expenditure individual 2004 (€) medical aids per insured in X of 16 Länder development in 2005 development in 2006 individual 2004 in 2004 (index year 2004) (index year 2004)

Hearing aids 3.71 8.32% 16 99% 95%

Incontinence aids 2.16 4.85% 10 109% 115%

Arch supports 3.89 8.73% 7 88% 86%

Ostomy products 1.79 4.02% 2 97% 91%

Compression therapy aids 2.66 5.97% 2 91% 74%

Source: Calculations, based on data of GEK Heil- und Hilfsmittelreport 2004–2007.

within two years to 91% of their 2004 public tenders. Under this policy, intro- Jahre 2004 und 2005 [GEK remedies and expenditure levels. Nevertheless, these duced in 2007, sickness funds are required aids report 2005: Outcomes of data evalu- decreases are much less pronounced than to use public procurement procedures. ation from 2004 and 2005]. Sankt Augustin: those seen after the introduction of They invite tenders from distributors (not Asgard-Verlag, 2005. Available at reference prices for pharmaceuticals.1,9 manufacturers unlike the situation for http://media.gek.de/downloads/magazine/ pharmaceuticals) for providing certain Heil-und-Hilfsmittel-Report-2006.pdf It should however be noted that the medical aids to their insured populations in 5. Deitermann B, Kemper C, Glaeske G. demand for medical aids is influenced by a specified area. Taking a closer look at the GEK-Heil- und Hilfsmittel-Report 2007: many other factors that are difficult to results of this new instrument will be well Auswertungsergebnisse der GEK-Heil- und control. Price elasticities for co-payments merited as soon as they become available. Hilfsmitteldaten aus dem Jahre 2005 und may vary between categories and thus may 2006. [GEK remedies and aids report 2007: cause expenditure change. Distribution of Outcomes of data evaluation from 2005 market power may also influence the levels REFERENCES and 2006]. Sankt Augustin: Asgard-Verlag, at which reference prices are set. In cate- 2005. Available at http://media.gek.de/ 1. Busse R, Schreyögg J, Henke KD. gories where manufacturers have strong downloads/magazine/Heil-und- Regulation of pharmaceutical markets in market power, the reference price could be Hilfsmittel-Report-2007.pdf Germany: improving efficiency and set rather high, whilst in other categories controlling expenditures? International 6. Nahnhauer A, Kaesbach W. Reimburse- the strong influence of the sickness funds Journal of Health Planning and ment of medical devices in Germany. may lead to markedly low prices and thus Management 2005;20:329–49. Health Economics in Prevention and Care to lower expenditures. Moreover, we have 2000;1:140–45. not been able to incorporate epidemio- 2. Scharnetzky E, Deitermann B, Michel C, 7. Brose B, Felder S. 2006. Stärkung des logical factors, such as change in the Glaeske G. GEK-Heil- und Hilfsmittel- Report 2004: Auswertungsergebnisse der Vertragswettbewerbs? Die gesetzlichen incidence of disease associated with certain GEK-Heil- und Hilfsmitteldaten aus dem Regelungen bei den Hilfsmitteln auf dem medical aids, into this analysis. Jahre 2003 [GEK remedies and aids report Prüfstand. [Strengthening the contract- Looking at our results from a macro 2004: Outcomes of data evaluation from competition? The statutory regulations for system-perspective, one overall conclusion 2003]. Sankt Augustin: Asgard-Verlag, medical devices put to test]. Essen: BKK at this stage is that while the reference price 2004. Available at http://media.gek.de/ Bundesverband, 2006. Available at system has contained expenditure within downloads/magazine/Edition31- http://www.bkk.de/bkk/powerslave,id,102 6,nodeid,.html the SHI system, it cannot automatically be Heilmittel_Report_ 04.pdf equated to increased efficiency as this 3. Scharnetzky E, Deitermann B, Hoffman 8. Deutsche Krankenhaus Gesellschaft. would require more detailed analysis of the F, Glaeske G. GEK-Heil- und Hilfsmittel- Gutachten 2005 des Sachverständigenrates precise changes in product price and use. Report 2005: Auswertungsergebnisse der zur Begutachtung der Entwicklung im Even if such data were to become available, GEK-Heil- und Hilfsmitteldaten aus dem Gesundheitswesen [Report 2005, careful analysis of the impacts on popu- Jahre 2003 und 2004 [GEK remedies and Coordination and Quality in the Health lation health, appropriateness and equity aids report 2005: Outcomes of data Care System]. Berlin: 2005. Available at evaluation from 2003 and 2004]. Sankt http://www.dkgev.de/dkg.php/cat/35/aid/ of care, as well as efficiency, would require Augustin: Asgard-Verlag, 2005. Available 2711/title/Gutachten_2005_des_ more of the types of data that are at https://www.gek. de/x-medien/dateien/ Sachverstaendigenrates_zur_Begutachtung commonly used within the health techno- magazine/Heil_und_Hilfsmittel_Report_ _der_Entwicklung_im_Gesundheitswesen logical assessment of pharmaceuticals. 2005.pdf 9. IKK Bundesverband. Übersicht über It may be that because of these difficulties, 4. Deitermann B, Kemper C, Hoffmann F, Festbetragsgruppen für Hilfsmittel vor 2005 Germany is already experimenting in new Glaeske G. GEK-Heil- und Hilfsmittel- [Summary of Reference Price Groups for ways of organising both access to and Report 2005: Auswertungsergebnisse der Medical Devices before 2005]. financing of medical aids, such as through GEK-Heil- und Hilfsmitteldaten aus dem Unpublished document.

11 Eurohealth Vol 14 No 3 PUBLIC HEALTH PERSPECTIVES Cancer control in Europe today: challenges and policy options

Delia-Marina Alexe, Tit Albreht, Martin McKee and Michel P Coleman

Summary: In spite of the advances in cancer control, cancer remains a huge problem in Europe, in terms of both morbidity and mortality. This article summarises the challenges posed by cancer in Europe today and the measures available to tackle them. It is based on ‘Responding to the Challenge of Cancer in Europe’, a collaboration between internationally recognised public health institutes in the European Union, under the umbrella Fighting Against Cancer Today (FACT).

Keywords: Cancer, Cancer Control, Inequalities, Prevention, Policy

Introduction A more recent achievement in primary the Human Genome Project Cancer has been known and researched prevention is the identification of the (http://www.genome.gov) now offer new since antiquity, but substantial progress in Human Papilloma Virus (HPV) as the perspectives for diagnosis, treatment, and cancer control has only been made in the cause of cervical cancer, and the devel- soon maybe prevention, of many diseases, last few decades. Greater understanding of opment of vaccines against carcinogenic including cancer. the causes of cancer has had a major impact types of HPV; some vaccines were licensed Life expectancy has increased dramatically. on both primary and secondary prevention in 2006 in the European Union. of cancer, as well as on treatment and A century ago, life expectancy in Europe rehabilitation. In terms of reducing human Secondary prevention, and specifically was less than forty-five years and the main exposure to cancer risk factors, one of the early diagnosis of breast and cervical causes of death were infectious diseases most important discoveries of the twen- cancers through organised mass-screening and diseases related to poor nutrition. The tieth century was the role of tobacco programmes, has led to a reduction in control of infant mortality in western smoking as a cause of cancers of the lung cancer mortality and an overall countries produced the first significant and various other organs.1 The outcome of improvement of the quality of life of gains in life expectancy; then, the intro- anti-smoking measures is now becoming cancer patients. A more recent oppor- duction of penicillin, sulfa drugs and strep- visible. Lung cancer incidence and death tunity for cancer control is faecal occult tomycin yielded another significant rates among men are decreasing steadily blood testing, which has been shown to reduction, this time in adult mortality. where they have been effectively imple- reduce mortality from colorectal cancer.3 From the 1960s onwards, an increasing mented, such as in western and northern array of drugs has made it possible to European countries.2 Although pharmacological treatment is control a growing number of chronic responsible for a small proportion of cures conditions, such as hypertension and in patients with cancer overall, its contri- asthma. The result has been a downward Delia-Marina Alexe is Clinical Research bution in tackling some types of cancer trend in morbidity and disability.5 Fellow, (testicular and breast cancer, leukaemia and Michel Coleman is Professor of Epidemi- Hodgkin’s disease) has led to an impressive However, these impressive gains have ology and Vital Statistics, Non-Communi- increase in survival from these cancers and coincided with, and indirectly contributed cable Disease Epidemiology Unit, and a significant reduction in the number of to, an increase in the burden of disease deaths.4 All these developments, along with attributable to cancer. In the WHO Martin McKee is Professor of European major innovations in imaging, surgery, and European Region, only 5% of cancer Public Health, Health Services Research radiotherapy, have radically changed the deaths occur in people less than forty-five Unit, all at the London School of Hygiene perception and management of cancer. years of age. The majority of deaths from and Tropical Medicine, London, United Some cancers can now be cured, while cancer occur after this age, three-quarters Kingdom. others are increasingly seen as a ‘chronic’ of which are in people aged sixty years and Tit Albrecht is Researcher in Health condition rather than a fatal disease, which older.6 The inevitable consequence of Services at the Institute of Public Health, means that a patient is more likely to die ageing and population growth in Europe Ljubljana, Slovenia. with a cancer, rather than of it. Advances in has been a very large increase in the burden Email: [email protected] genetics and in genetic epidemiology and of cancer.

Eurohealth Vol 14 No 3 12 PUBLIC HEALTH PERSPECTIVES

For these reasons, in spite of the advances the upward pressure of these demographic Progress in cancer control can be seen in in cancer control, cancer remains a huge changes on the numbers of new patients most countries, but in some, cancer control problem in Europe, in terms of both that health systems will have to manage.2 is still in its infancy. Efforts to tackle cancer morbidity and mortality. This article Cancer patients will be older than today, in northern and western European coun- summarises the challenges posed by cancer and many will have several co-existing tries during recent decades have resulted in in Europe today and the measures designed illnesses, so the health needs of cancer decreasing mortality and increasing to tackle them. It is based on ‘Responding patients will become even more complex. survival from those cancers that are to the Challenge of Cancer in Europe’, a This upward demographic pressure on the amenable to either primary or secondary collaboration between internationally cancer burden is one of the biggest prevention (for example, lung cancer, recognised public health institutes in the challenges in cancer control. breast and cervical cancers). By contrast, in European Union, under the umbrella some countries that have joined the EU Implementation of effective strategies for Fighting Against Cancer Today (FACT).* since 2004, the lack of financial and human cancer control is essential to counteract FACT is co-funded by the Government of resources, along with uncoordinated these trends. These measures must include Slovenia and the European Commission’s primary, secondary and tertiary efforts in the organisation of cancer Health and Consumer Protection Direc- prevention. In particular, measures are control, has been associated with an torate. Participating institutions include the needed to tackle tobacco smoking, the increase in mortality and a poor prognosis National Institute of Public Health of most preventable cause of cancer; to for cancers that could have been prevented, Slovenia as the co-ordinators, the London promote mass (population-based) or detected in an early phase. Furthermore, School of Hygiene and Tropical Medicine, screening programmes for cancers of the at the population level, a lack of cancer the Institute of Oncology in Ljubljana and cervix, breast and large bowel (colon and awareness in central and eastern European the European Observatory on Health rectum), and to extend the adoption and countries has been described, especially in Systems and Policies. accessibility of effective treatments to all regard to prevention as a means of cancer 10 patients within an ‘integrated care’ system. control. Cancer: current challenges and cancer Lastly, adequate provision for greater control A dramatic contrast in mortality from numbers of cancers among older people is cervical cancer has been described between The burden of cancer essential. EU Member States in western Europe and Worldwide, about ten million people are Inequalities in cancer in Europe those in central and eastern Europe. Death diagnosed with cancer each year. A sharp from cervical cancer is now relatively Europe has some of the richest countries increase of 50% in the incidence of cancer uncommon in western European coun- in the world, but also some of the poorest. has been predicted by 2020, mainly due to tries, but in Latvia, Bulgaria, Lithuania and In 2002, 168 million people were living ageing populations in both developing and Romania there is a continuing increase in below the poverty line, about 46% of the developed countries, but also as a result of cervical cancer mortality. In Romania, European population.9 These socio- current trends in smoking prevalence and mortality from cervical cancer has reached economic differences are reflected in the growing adoption of unhealthy levels that have never been seen before in significant health gaps not only between 10 lifestyles.7 One-third of the global burden Europe. In the late 1990s, there was a and within the countries of the European of cancer is recorded in Europe: in 2006, greater than tenfold difference between the region, including the European Union. there were 3.2 million new cases of cancer highest cervical cancer death rate, in They are seen in both the burden of cancer and about 1.7 million cancer deaths. In the Romania, with no organised mass- and the range of survival. Differences in 25 EU Member States (EU25 – pre-2007), screening programme, and the lowest the burden of cancer result mainly from one out of four deaths was attributed to death rates in Finland and Sweden, where international differences in exposure to cancer. Most cases and most cancer deaths population coverage of cervical cancer cancer risk factors (for example, prevalence are due to four common cancers, those of screening is almost 100%.11 The treatment of smoking, unhealthy diet, obesity) and breast, prostate, lung and large bowel.8 environment for cancer patients is also socioeconomic characteristics; however, extremely difficult in Romania, as the The number of new cases and cancer they are also an indicator of the overall concept of integrated care is non-existent. deaths in Europe has increased and is likely delivery of services for the prevention and Another dire example is that of Estonia, to rise further. The accompanying treatment of cancer, including organised where population-based medical registries improvement in survival has led to an even screening programmes, the existence and and epidemiological research are still seri- greater increase in prevalence. Projections accessibility of health care facilities and ously hampered by data protection legis- of future cancer incidence indicate that technological infrastructure, and the avail- lation that omits any of the exemptions even if the risk of getting cancer at each age ability of human, financial and material provided under the EU Directive for the does not change, the number of new cancer resources for health and economic devel- processing of personal data for historical, patients diagnosed each year in the pre- opment. A survey by the European statistical or scientific purposes. This has 2007 EU25 Member States will rise by Society of Clinical Oncology, designed to completely disabled surveillance of trends 20% in the eighteen years between 2002 assess the status of medical oncology in in cancer incidence and survival.12 and 2020, simply due to population Europe (MOSES, Medical Oncology growth and ageing. Incidence rates would Status in Europe Survey, www.esmo.org/ Health inequalities between ‘old’ (pre have to fall by more than 1% every year resources/surveys/mosesII_survey/?get_ 2004) and the twelve ‘new’ EU Member over that period in order to counterbalance resource=241), has found significant States merit particular attention from both discrepancies in the provision of cancer the health authorities of the countries care throughout Europe, including access concerned and the EU as a whole. Cancer * website http://www.projectfact.eu to surgery, radiotherapy and cancer drugs. control must be a priority for the

13 Eurohealth Vol 14 No 3 PUBLIC HEALTH PERSPECTIVES

European Commission, both now and in tially.14 Although the role of diet in cancer reducing average body weight, but it has future action plans. There is a particular causation is still relatively under-explored, also been linked to a reduction in the risk need to support the most severely affected it has been estimated that about one-third of cancers of the breast, body of the uterus Member States, and scope for this is of all cancer mortality may be related to and prostate, independently of weight offered by the Commission’s Structural unhealthy diets,15 while a diet low in fresh control.14 Funds. Exchange of best practices in fruit and vegetables seems to increase the Interventions to tackle cervical cancer cancer control across the EU, backed up risk of cancer in those exposed to other should be tailored to the particular situ- by substantial funding in countries where carcinogens.16 There is also evidence ation of each country. For example, HPV the health care system is in ‘transition’ and supporting the role of obesity as a cause of vaccination would provide a new approach cancer control measures are under devel- some cancers.13,14 Preventing skin cancer to preventing cervical cancer, particularly opment, could also substantially reduce remains equally important, because the in countries with a high incidence of the these inequalities in cancer outcomes. incidence of melanoma of the skin in disease and inadequate screening.18 To Europe has doubled since the 1960s. Within countries, adequate political and prevent infection with hepatitis B virus in financial support is needed to enable the Viruses such as HPV and the hepatitis B Europe, systematic vaccination is needed creation and operation of population- and C viruses cause more than 20% of as a part of national immunisation based screening programmes and cancer cancers in developing countries but only programmes. No vaccine is yet available to registries. This should include an appro- about 8% of all malignancies in developed prevent infection with hepatitis C virus. priate legislative framework and stable countries.7 This gap is also apparent in Costs of diagnostic and treatment services long-term funding. National education Europe, where cervical cancer is a major programmes should be implemented to problem in central and eastern European Early diagnosis and optimal treatment of change attitudes towards cancer and cancer countries.10 cancer is complex. It requires education, prevention, building upon initiatives such prevention, diagnosis, treatment and A broad policy framework is needed for as the European Code Against Cancer. palliative care. One of the most important cancer control in Europe. Policy will need challenges in cancer control is to coor- Key risk factors for cancer and prevention to harness some essential tools for the dinate national plans and services to cover policies prevention of tobacco smoking and all aspects of the management of cancer. alcohol consumption, such as the WHO Some lifestyle factors, such as tobacco Framework Convention on Tobacco During the last decade, the diagnosis and smoking, alcohol consumption, unhealthy Control and the Framework for Alcohol treatment of cancer have become increas- diets and lack of physical exercise, or Policy in the WHO European Region. ingly expensive, as a result of rapid excessive exposure to sun, play an Effective strategies to reduce tobacco and advances in technology and drug devel- important role in the causation of cancer. alcohol consumption include pricing opment. Pressure from the pharmaceutical The biggest challenge in primary policies, policies to reduce the harm caused industry has led to the prioritisation of prevention remains tobacco smoking, by exposure to environmental tobacco drugs over other treatment modalities. The linked to between 80–90% of lung cancers smoke and harmful drinking of alcohol, oncology drug market is expected to grow and between 40–60% of cancers of the policies to reduce demand and limit access steadily as a result of the ageing popu- oesophagus, larynx and oral cavity.13 (in particular the locations and times when lation, the development of new treatments Despite the significant impact of anti- alcohol can be purchased), and by the and advances in cancer genetics. Develop- smoking interventions implemented in avoidance of internal market policies that ments in molecular pathology, imaging, some countries since the early 1980s, lung promote consumption.13,17 Unfortunately, radiotherapy and surgery are at least as cancer is still the leading cause of cancer both the tobacco and alcohol industries important in the management of cancer, death in Europe. Importantly, although have been successful in preventing effective and should also be strongly encouraged by lung cancer rates in males have stabilised action in many countries, often promoting the EU, along with long-term investment or have been decreasing in northern and campaigns to undermine the evidence in the training of staff and the acquisition western European countries, lung cancer about effective health policies. and/or renewal of equipment.17 mortality among women is still rising in many European countries, in particular in Another tool is the European Code New and expensive drugs that offer no southern and eastern European countries.2 Against Cancer, an integrated instrument substantial advantage over existing treat- While some European countries have for cancer prevention. It focuses on ments are being promoted. This places a made impressive progress in tobacco promoting the adoption by individuals of further burden on national health services, control, others still have much to do. It is healthy lifestyles, including participation insurers and cancer patients. For example, remarkable that many countries still allow in screening programmes.14 It provides an one cycle of temozolomide, used in smoking in public places. important basis for health promotion by treating some brain tumours, is 350 times health care professionals and non-govern- more expensive than the reference drug Another challenge in cancer prevention is mental organisations. procarbazine, although these two are the excessive consumption of alcohol, largely equivalent in terms of efficacy and twice as high in Europe as the world Most countries in Europe have seen a rapid safety.4 average. Alcohol is a cause of several increase in the prevalence of obesity in cancers, such as those of the upper recent years: tackling this epidemic should The increase in the cost of cancer care, and digestive and respiratory tract, and become a priority in the EU.13 The Global in the cost of drugs in particular, is likely to primary liver cancer.13.14 When alcohol Strategy on Diet and Physical Activity prevent equal access to optimal care to all consumption is combined with tobacco provides a solid basis for action. patients in an economically limited system, smoking, cancer risk increases exponen- Promoting physical activity would help in with different countries choosing different

Eurohealth Vol 14 No 3 14 PUBLIC HEALTH PERSPECTIVES thresholds to trigger the availability of protect cancer registration.17 Reducing Challenge of Cancer in Europe. Ljubljana: drugs for defined groups of patients.19 A health inequalities across the EU should Institute of Public Health of the Republic recent example from England concerns the also be a priority: more support and of Slovenia, 2008:253–78. proposal by the National Institute for investment are needed in the most affected 11. Levi F, Lucchini F, Negri E et al. Health and Clinical Excellence (NICE) for Member States. Measures to control the Cervical cancer mortality in young women the ‘rationalisation’ of chemotherapeutic effects of unhealthy lifestyles have an in Europe: patterns and trends. Eur J treatment for kidney cancer with four important potential to supplement health Cancer 2000;36:2266–71. types of drugs, based on their lack of cost- care provisions everywhere. These include 12. Rahu M, McKee M. Epidemiological effectiveness for treating patients with strategies to tackle tobacco smoking and research labelled as a violation of privacy: advanced or metastatic renal cell alcohol consumption, and those which the case of Estonia. Int J Epidemiol. 20 carcinoma. promote healthy nutrition and physical 2008;37:678–82. activity, safe occupational and environ- Health care policy-makers and funders 13. Martin-Moreno JMM, Magnusson G. mental guidelines, as well as the prevention need to examine the cost-effectiveness of The causes of cancer and policies for of infections that cause cancer. new technologies as closely as the efficacy prevention. In: Coleman MP, Alexe DM, of the drugs themselves. National govern- Albreht T, McKee M (eds). Responding to ments have a responsibility to establish the Challenge of Cancer in Europe. REFERENCES mechanisms to ensure that clinically Ljubljana: Institute of Public Health of the proven interventions that maximise both 1. Doll R, Peto R. Mortality in relation to Republic of Slovenia, 2008:41–68. the duration and quality of life are smoking: 20 years’ observations on male 14. Boyle P, Autier P, Bartelink H et al. available to all their constituents. Robust British doctors. British Medical Journal European Code Against Cancer and health technology assessment is essential, 1976;2:1525–36. scientific justification: third version (2003). followed by equity in the distribution of 2. Bray F. The burden of cancer in Europe. Ann Oncol. 2003;14:973–1005. treatment resources.19 In: Coleman MP, Alexe DM, Albreht T, 15. Divisi D, Di TS, Salvemini S, McKee M (eds). Responding to the Garramone M, Crisci R. Diet and cancer. Cancer control: an integrated approach Challenge of Cancer in Europe. Ljubljana: Acta Biomed. 2006;77:118–23. It has been estimated that a quarter of Institute of Public Health of the Republic of Slovenia, 2008:7–39. 16. Lock K, Pomerleau J, Causer L, McKee cancers could be prevented by applying M. Low fruit and vegetable consumption. existing knowledge, while a further third 3. Hakama M, Coleman MP, Alexe DM, In: Ezzati M, Lopez AD, Rodgers A, of cancers may be curable using current Auvinen A. Cancer screening. In: Coleman Murray CJL (eds). Comparative treatments and technologies.7 For fatal MP, Alexe DM, Albreht T, McKee M (eds). Quantification of Health Risks: Global and cancers, palliative care is an essential Responding to the Challenge of Cancer in Regional Burden of Disease Due to Selected component of cancer care. It is aimed both Europe. Ljubljana: Institute of Public Major Risk Factors. Geneva: WHO; at improving the quality of care for cancer Health of the Republic of Slovenia, 2004:597–728. 2008:69–92. patients and their families, and at helping 17. Albreht T, McKee M, Alexe DM, them both to live well until they die, and 4. Garattini S, Bertele V. Efficacy, safety, Coleman MP, Martin-Moreno JM. Making 21 to die well. An integrated strategy for and cost of new anticancer drugs. BMJ progress against cancer. In: Coleman MP, cancer control must thus include all 2002;325:269–71. Alexe DM, Albreht T, McKee M (eds). elements of prevention, as well as 5. Anonymous. The future of human life Responding to the Challenge of Cancer in treatment, palliative care and research. expectancy: have we reached the ceiling or Europe. Ljubljana: Institute of Public is the sky the limit? Research Highlights in Health of the Republic of Slovenia, At a national level, a key requirement for the Demography and Economics of Aging 2008:315–27. successful cancer control is the devel- 2006;8:1–4. opment of a coordinated cancer plan. 18. Raffle AE. Challenges of implementing WHO published six guides as a framework 6. World Health Organization. Revised human papillomavirus (HPV) vaccination for a comprehensive planned approach to Global Burden of Disease (GBD) 2002 policy. BMJ 2007;335:375–77. cancer control. These can be used to Estimates. Geneva: World Health 19. Sikora K. Drugs for cancer. In: identify priorities for action and research Organization, 2004. Coleman MP, Alexe DM, Albreht T, across the entire spectrum of cancer 7. World Cancer Report. Lyon: WHO McKee M (eds). Responding to the control. Implementation of these activities International Agency for Research on Challenge of Cancer in Europe. Ljubljana: needs to be monitored constantly, Cancer, IARC Press; 2003. Institute of Public Health of the Republic of Slovenia, 2008:93–112. alongside the overall efficacy of the health 8. Ferlay J, Autier P, Boniol M, Heanue M, system, one indicator of which is cancer Colombet M, Boyle P. Estimates of the 20. O’Dowd A. Watchdog set to reject four survival. Cancer information systems such cancer incidence and mortality in Europe drugs for kidney cancer on the NHS. BMJ as screening registries and cancer registries in 2006. Ann Oncol. 2007;18:581–92. 2008;337:1262. are essential tools; their operation requires 9. WHO Regional Office for Europe. The 21. Higginson I, Costantini M. Dying with adequate investment and legal protection. European Health Report. 2002. Copen- cancer, living well with advanced cancer. At the EU level, measures to complement hagen: WHO Regional Publications, In: Coleman MP, Alexe DM, Albreht T, McKee M (eds). Responding to the national policies in Member States are European Series, No. 97. Challenge of Cancer in Europe. Ljubljana: needed. For example, the 1995 EU data 10. Zatonski W, Didkowska J. Closing the Institute of Public Health of the Republic protection directive has impeded the gap: cancer in central and eastern Europe. of Slovenia; 2008:231–52. effective operation of cancer registries. The In: Coleman MP, Alexe DM, Albreht T, Directive must be revised to enable and McKee M (eds). Responding to the

15 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS Lampedusa and pharmaceutical distribution: community pharmacy in the 21st century

Ricard Meneu

Summary: Within the context of the countries belonging to the EU before May 2004 (EU15), regulation of the pharmaceutical industry is currently under close scrutiny. Attempts at reform often attract the attention of various stakeholders and European institutions, who may flag up violations of European Community norms in Member State legislation. Although much of the debate revolves around business issues (i.e., property, planning, mergers and acquisitions) there is a real need to redefine the professional activities of pharmacy personnel whose roles have changed radically over recent decades.

Key words: Community Pharmacy, Regulation, Profession, Incentives, Public Health

“If we want things to stay as they are, things will have to change” from The Leopard, Giuseppe Tomasi di Lampedusa (1958).

In 2008, the European Commission EU15; however, the pace of these regula- save money that would otherwise be tied initiated infringement proceedings against tions has not kept up to speed with devel- up in inventory. Germany over its restrictions on the opments in the sector. Since the Wholesalers perform two broad functions ownership of pharmacies. Similar actions mid-twentieth century, the activities of the in the supply chain of the pharmaceutical have been undertaken against the regu- community pharmacy have altered consid- industry: (i) they provide basic logistic lation of pharmacies in Spain, France, erably. Pharmacists, who originally functions for pharmaceutical distribution, Austria and Italy. These infringement operated as drug producers, have now bridging distances and time, while assuring procedures concern a series of restrictions moved towards activities related to the quality and quantity, and (ii) they provide relating to the opening and running of distribution of manufactured products that services that may add value to both phar- pharmacies including: the incompatibility are already scrupulously labelled by the maceutical manufacturers and retailers, between the distribution and retail sale of pharmaceutical industry. These products including sales analyses, marketing assis- pharmaceutical products; having the are delivered directly to the pharmacy tance and product training, special ownership of pharmacies reserved exclu- through the wide-reaching logistics of handling services and product recalls.1 sively for pharmacists; territorial and wholesale distributors, who centralise However, this major shift in the responsi- demographic limits in the setting-up of purchasing and deliver to individual bilities and duties of the different players pharmacies; and a ban on owning more pharmacies up to five times a day. It is in the sector has hardly been reflected in than one pharmacy. these intermediaries who provide the the design of new governance regulations. majority of the value associated with the The distribution and dispensation of drugs Regulations, thus, have become outdated drug distribution system, since they is a highly regulated activity in most of the and no longer correspond to the current guarantee pharmaceutical supply and parameters of a sector which has changed accessibility. Because pharmacies no longer substantially since the laws to regulate it Ricard Meneu is based at the Fundación need to hold substantial stocks, they can were originally put in place. Instituto de Investigación en Servicios de Salud, Valencia, Spain and the Research Centre on Health and Economics (CRES), Universitat Pompeu Fabra, This study was supported by an unrestricted grant from the Merck Company Foundation, Barcelona, Spain. Whitehouse Station, New Jersey, USA, to CRES, Universitat Pompeu Fabra, Barcelona. Email: [email protected] The views expressed are those of the author alone.

Eurohealth Vol 14 No 3 16 HEALTH POLICY DEVELOPMENTS

The regulation of drug distribution and central to the problem), are the professional Furthermore, if “pharmacists must be dispensation has become a battle ground activities conducted in pharmacies. It is independent from major market entities or with each player vying to draw the regu- precisely these activities that justify a other parties that might influence profes- lator to his own corner, and boost his share requirement for certain technical qualifica- sional decisions”5 it does not seem of the pie. However, the whole process has tions to dispense what are none other than reasonable that in some countries it is progressively neglected to provide any manufactured, pre-labelled products. These pharmacists who are the owners of most added value to population health issues are now discussed in more depth. distribution companies, established under improvement. the format of ‘cooperatives’. This type of Property bottom-up vertical integration leaves them One analysis of the major features of Access to ownership of pharmacies varies open to the same risks of “commercial pharmacy regulation reveals that, as a throughout Europe, although in ten of the pressures” as the opposite, prohibited, top- professional collective, the European EU15 countries, it is limited to qualified down integration under which wholesalers Community’s pharmacists have managed pharmacists. This restriction, together with can, in turn, be owners of pharmacies. to maintain a long-standing monopoly another that limits the number of phar- over the supply of drugs, both prescription Under scrutiny, limiting ownership of macies that one proprietor can own, can and over-the-counter products, and to pharmacies to qualified pharmacists is not make it difficult to develop strategies that control the number and location of phar- justified in operational terms. It clashes would have a favourable impact on effi- macies, while limiting the right to ciency, such as certain types of horizontal with both the regulation of some national 2 ownership of these establishments. It is integration to obtain economies of scale or markets and rules governing other health more difficult to explain the frequent scope or other (cost) advantages.2 care establishments. Even in the case of alignment of health care authorities with complex organisations providing health the pharmacists’ interests. Some would Most Member States allow horizontal care services (for example, specialised argue that such regulatory capture is, cooperation. Both partnerships with other hospitals) there are no similar rules overall, against the interests of society as a pharmacies and integration with druggists limiting ownership to specific profes- whole. are allowed in a majority of cases. Vertical sionals, as there are no limitations on integration is restricted. Seven Member shareholder composition. The laws governing pharmaceutical distri- States allow pharmacists and wholesalers bution have been reiteratively examined in to integrate; while only six Member States Planning European countries to verify the ‘rent allow integration between pharmacists and In order to ensure that pharmacy services seeking’ hypothesis. Results coincide in producers. Countries with no chains of and medicines are conveniently accessible showing that, for the most part, legislation pharmacies include Denmark, Spain, to all citizens and to avoid the situation is oriented towards restricting the entry of 2,4 France, Germany and Austria. where pharmacies are concentrated in players, or limiting competition between highly populated urban areas, several existing players, thus reinforcing the pre- Prohibiting non-pharmacists or legal Member States have criteria on the estab- eminence of private interests at the expense entities not consisting of pharmacists from lishment of new pharmacies. of the public good.3 having holdings in pharmacies goes beyond what is necessary to achieve the Seven of the EU15 countries studied set As a result of these tensions, in most of the objective of public health protection, since requirements on their location. The most EU15 countries, regulatory aspects of it would be sufficient to require the common restrictions are related to a debatable efficiency are continuously presence of a pharmacist to dispense medi- minimum number of potential customers being challenged. Particular attention is cines to patients and to manage stocks. and a minimum distance between phar- paid to the four ‘Big Ps’ – property Since compliance with professional stan- macies. In general, these planning (ownership), planning, payment and dards is guaranteed independently of the measures translate into relatively simple professional services. Regulations presence of the owner on the premises, rules that may be based on arbitrary governing property translate into the requiring owners to be qualified pharma- figures which leave a wide berth for discre- accepted monopoly whereby only phar- cists is a redundant measure. tionary decisions. macists can own pharmacies. They involve the control mechanisms on access to The champions of this model, i.e. current A reasonable distrust of the efficiency of ownership and restrict its scope. Added to owners and their professional ‘guilds’ these mechanisms is reflected in some of claim that “rules on the ownership are this is the questionable congruence of the ‘infringement proceedings’, that established by national legislation to guar- reserving for these establishments a indicate that some of the measures adopted antee the independence of the profession, monopoly on sales of all drugs, including do not in fact achieve their intended objec- to ensure that decisions are not taken those that do not require a medical tives. They can be counterproductive to solely for commercial reasons and to guar- prescription. the goals of ensuring a good supply of antee the provision of high quality medicines across a country. There are limitations on the number of pharmacy services”.5 This, however it pharmacies that may be opened in keeping might be argued, fools no one, as it is Another concern is that these mechanisms with planning criteria related to demo- unlikely that a businessman’s professional may lead to the creation of artificially graphic or geographic features that would qualifications will lead him to act against protected monopolies which then use guarantee accessibility. Reimbursement or his own interests. On the contrary, profes- cross subsidies to support activities that are payment systems, with various fees, sional qualifications can supply the owner not profitable. Alternative solutions have constant margins, capped margins and with the knowledge and skills necessary to been proposed, such as the establishment rebates may be questioned. Though the implement practices just this side of what of transparent subsidies to pharmacies, object of less heated debate (although is acceptable. provided on the basis of sound public

17 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS interest objectives, in situations where products that have similar costs in terms of Conclusions activities could not be performed on a supply, storage, conservation and dispen- The discourse over the regulation of the profitable commercial basis.4 Versatile sation. There is a clear need to redefine the pharmaceutical distribution sector invokes distribution systems are needed to help criteria for remuneration of pharmacies, as public safety and consumer protection. It ensure access for both people living in is stated in the Resolution of the Council of generally masks the desire to preserve in remote rural areas and those who may find Europe ResAP (2001) 2 concerning the statu quo and thus inhibit any devel- it difficult to travel to a pharmacy. One pharmacist’s role in the framework of opment that may actually benefit the users option, to date under-exploited because of health security. This recommends that “the of distribution services over pharmacy legal restrictions in many EU-15 countries, system under which (pharmacists) are owners.8 There is no doubt that public could involve dispensing drugs over the remunerated must be reviewed to reflect health must be guaranteed through the internet. the professional service they provide rather distribution of drugs; however, in order to than the profit margin or volume of their do this, clear objectives must be defined sales, in accordance with Resolution AP and mechanisms established to meet the “To define the objectives (93)1 on the role and training of goals sought, followed by careful evalu- community pharmacists”.7 ation of their empirical efficiency. This is essential to a 21st century very different from what is happening community pharmaceutical Professional activities today when out-dated strategies, designed sector, it is necessary to promote Other concerns less frequently addressed, for a time when the activities of pharma- although central to this discussion, relate cists were very different, are being the interests of demand over to whether professional activities justify preserved. those of supply. This will the need for specific qualifications. Today, The sector also invokes the nebulous require redesign of regulation pharmacists largely dispense manufactured notion of ‘public health’, even though the products that are carefully labelled against and incentive systems” effects of the current system can include a prescription document, which generally the preservation of unfair monopolies that includes specifications about the product, only enhance revenues for pharmacists, the dosage, person for whom the product is evident capture of the regulator by the Payment intended, along with a justification of the objects of regulation and the maintenance Payment systems provide an efficient way indication. of unsuitable payment schemes. All of this to orient any sector’s agents towards a Although “common medicinal products, can be set against the absence of a clear specific role, and pharmaceutical distri- such as paracetamol and aspirin, can be definition of both the desirable profes- bution is no exception. Depending on the dangerous if they are not taken in appro- sional services to be rendered and their system adopted, a pharmacy’s income is priate quantities and in the appropriate contribution to population health linked to a greater or lesser extent to the way”,5 this does not mean that every improvement. price and number of products dispensed, dispensing act requires professional advice Any analysis of current regulation must or the professional services it provides. and counsel. When an individual patient clarify whether current laws promote or There are three basic financing categories:6 buys aspirin time and time again, it is not inhibit efficiency in the sector, and whether those that are product oriented, those that usually necessary for the pharmacist to they translate into real benefits for are patient oriented, and those that are a remind him or her of the risk of stomach consumers instead of acting as a mech- combination of the two. While the latter bleeding associated with its analgesic and anism to hike up prices unnecessarily. An two are similar to the payment schemes cardio-protection properties. Current adequate evaluation of sector regulation usually adopted to remunerate other legislation obviously does not require the would require, on the one hand, a country professional health care providers – fee for provision of such services. by country comparison, accompanied, service, capitation and salaries – ‘product above all, by an exhaustive analysis of the oriented’ schemes are more similar to retail Any redefinition of the professional role of tensions that exist between the pharmacy, reimbursement models. pharmacists will necessarily incorporate claims of the need to pay for ‘Pharmaceu- a venue that not only retails drugs, but that Pharmacists usually receive a fee related to tical Care’ (PC), a concept that has not should also provide professional services, the number of transactions they conduct. been clearly defined. So pending the and all of the other stakeholders partici- More specifically, they receive a fixed fee demonstration of the overall efficiency of pating in the drug-provision cycle. and/or a percentage (fixed or variable PC, the implementation of programmes to To define the objectives essential to a margin) of the drug price per dispensed review utilisation for the purpose of devel- twenty-first century community pharma- prescription drug. The fixed fee is oping schemes for professional devel- ceutical sector, it is necessary to promote supposed to reimburse pharmacists for opment, while a difficult task, is one that the interests of demand over those of their provision of pharmaceutical services. will no doubt benefit all stakeholders. The supply. This will require redesign of regu- However, the fact that this reimbursement flashy promises of PC, a concept that has lation and incentive systems, in an effort to is related to the number of prescriptions not even reached an embryonic stage, may align the interests of (i) professional phar- rather than to the actual provision of phar- be making us forget the fact that the mere macists, as providers of valid specialised maceutical services has been criticised by verification ex ante of therapeutic services and not only as mere drug some authors.1 compliance and avoiding certain interac- retailers, (ii) the health care system in Systems based on the payment of margins tions and counter indications would which this sector has been integrated until are undesirable in an environment where provide substantial added value that is now in an anomalous position and iii) the there is a wide variability in the pricing of currently absent in the current situation. public which it supposedly serves. Any

Eurohealth Vol 14 No 3 18 HEALTH POLICY DEVELOPMENTS measures adopted should pursue the goal of improving the health of the population The over-the-counter by tapping into the professional qualifica- tions of pharmacists that are currently wasted on task of lesser importance. This pharmaceutical market – is not so much a question of improving economic benefits, but of moving towards a sector design that corresponds with the policy and practice current drug-provision cycle. This approach would thus account for the changes that have taken place in recent years, rather then continuing to perpetuate what is now an outdated image of the sector. Christine Bond

REFERENCES Summary: The European non-prescription medicines and consumer over-the- 1. Indecon. Review of Pharmacy Wholesale counter (OTC) self-medication market is today worth some €29 billion at Margins. Naas: Health Service Executive, consumer prices and represents 36% of world sales.1 In this personal reflection 2007. Available at http://www.hse.ie/en/ from a UK perspective, I consider the background to and changing context of Publications/HSEPublicationsNew/PCCC OTC medicines, the implications for the pharmacy profession and patients, and Reports/IndeconReport/ the benefits and challenges. 2. Volkerink B, de Bas P, van Gorp N, Philipsen N. Study of Regulatory Restric- Keywords: Over-the-counter Pharmaceuticals; Pharmaceutical Policy, UK tions in the Field of Pharmacies. Rotterdam: ECORYS Nederland BV, 2007. Available at http://ec.europa.eu/internal_ market/services/docs/pharmacy/report_en. In most of the world, access to and supply (CD) which are subject to additional pdf of medicines is governed by a regulatory controls, and herbal medicines which are 3. Philipsen NJ, Faure MG. The regulation framework which is based on perceptions least controlled (see Table 1). of pharmacists in Belgium and the Nether- of the risks and benefits of the medicine to Although this paper is about the OTC lands: in the public or private interest? the population. In the UK, for example, market, which is traditionally understood Journal of Consumer Policy there are three broad categories of medi- to be P and GSL medicines, it is important 2002;25:155–201. cines: POM (prescription only medicines), to be aware of POM medicines as the three P (pharmacy supervised sale), and GSL 4. Organisation for Economic Cooperation categories together contribute to the phar- and Development. Competition and regu- (general sales list). maceutical market which is in dynamic lation issues in the Pharmaceutical POM medicines are primarily only equilibrium. When a new medicinal Industry. Paris: OECD, 2001. available to the public when prescribed by compound is first licensed for use by the 5. Matias L. Regulation of Professional a medical practitioner, although histori- public in the UK, and depending on the Services. Presentation of the Pharmaceu- cally dentists have long been able to supply evidence of safety and efficacy in the pre- tical Group of the European Union at from a limited Dental Formulary. More marketed period, it is classified as POM. Conference on the Regulation of Profes- recently in the UK, full prescribing rights After two years this classification defaults sional Services. Brussels: Commission of have also been accorded to other health to P unless there is a specific application to the European Communities, 2003. care professionals such as nurses and phar- Available at http://ec.europa.eu/comm/ retain the POM status, which is the more macists, as long as certain specified condi- competition/sectors/professional_services/ normal practice. Subsequent moves to conferences/20031028/ tions are met. P medicines can only be sold reclassify a medicine require a rigorous under the supervision of a pharmacist from process of evidence submission to, and 6. Huttin C. A critical review of the premises registered with the Royal Phar- consultation by, the MHRA (Medicines remuneration systems for pharmacists. maceutical Society of Great Britain and Health care products Regulatory Health Policy 1996;36:53–68. (RPSGB), and GSL medicines are available Agency). In Europe there is also clear 7. Council of Europe. Resolution ResAP from any retail outlet. When moving from guidance on the criteria to be applied when (2001) 2 concerning the pharmacist’s role in POM through to P then GSL there is an retaining a medicine in the POM category the framework of health security. Available increasing ease of public access to (Directive 92/26/EEC). These are at http://www.correofarmaceutico.com/ medication and an equivalent decrease in summarised in Box 1. adiccion/CEResolucionOFU21.pdf professional control and vice versa. Within 8. Taylor D, Mrazek M, Mossialos E. this framework are ‘controlled drugs’ In general, a large subset of POM medi- Regulating pharmaceutical distribution and cines and a smaller proportion of P and retail pharmacy in Europe. In Mossialos E, GSL medicines are supplied within a Mrazek M, Walley T (eds). Regulating Christine Bond is Professor of Primary national state health care system, through Pharmaceuticals in Europe: Striving for Care: Pharmacy and Head of Centre of systems ranging from ‘no cost’ to the Efficiency, Equity and Quality. Academic Primary Care, Aberdeen, patient (for example, Wales) to co- Buckingham: Open University Press, 2004. Scotland. Email: [email protected] payment systems based on a range of

19 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS

Table 1: UK medicines classification and implications for supply, record keeping and professional treatments they can provide to patients control presenting symptoms in community phar- macies. In general, the medical profession Classification Supply controls Record keeping Level of control have supported the deregulation in prin- ciple,4 although caveats have been CD Misuse of Drug Special supply Records in Most professional control expressed for certain specific medicines. A Act schedules regulations apply controlled drugs – least patient control. recurring issue is whether or not, as register and Hardest to access professionals, pharmacists are qualified to routine records diagnose, a skill which is clearly the first POM Prescription only Prescribed by specified Record kept step when considering the patient’s medicine health care professional symptoms and considering ‘prescribing’. This is despite the fact that in the early 20th century, and in the UK specifically P Pharmacist Sold by or under the Record rarely kept before the introduction of the NHS in supervised sale supervision of a pharmacist 1948, many people obtained the vast majority of their advice and treatment GSL General Sales Available from any Record never kept from their local pharmacist, depending on List medicine retail outlet what were known as ‘Chemist’s Nostrums’ to cure their various ills. Herbal New regulations Available from any Record never kept Most patient control – Bearing in mind these concerns therefore, imminent retail outlet and some self least professional control. the first medicines to be deregulated appointed specialist shops Easiest to access tended to be for conditions that pharma- cists had historically diagnosed, such as diarrhoea. Indeed loperamide was one of different models (for example, France or budgets have continued to rise year on the first of the recent tranche of deregula- England). Whilst most of the POM medi- year there has been a wish to transfer drug tions providing a safe and effective remedy cines would fall within a state health distribution costs from the government to in lieu of the traditional codeine or other system, OTC drugs, sold to the public, the individual consumer. It is also said that opiate-based remedies (1983). As time more generally become part of private this shift in responsibility for care from the went on, and as the confidence of the health care. professional to the individual consumer public and opinion leaders in health grew, will empower the public, widen access to Since the late 1980s in Europe, and more medicines already available for an estab- medicines2 and bring additional financial recently in other parts of the developed lished diagnosis, for example, hydro- return to the pharmaceutical industry, world such as the USA and Australia, there cortisone for contact dermatitis, were particularly for drugs nearing the end of have been moves to increase the numbers proposed for deregulation for additional their protected, patent, period. of medicines available OTC, and the above indications such as eczema, and for longer European criteria and re-regulation The trend to deregulation from POM term use. The final and then logical move processes have been extensively applied status has also been supported by the was to deregulate new medicines for new and adopted. The rationale for these moves pharmacy profession3 as a way of diagnostic areas, whilst operating within has been multifactorial. Firstly, as drug extending the range of effective advice and the European framework. Examples of

Box 1: European criteria for retaining a Figure 1: Progress from POM to P and overall cultural change medicine in the POM category A cultural leap (1983–2005)

• There is direct or indirect danger to health Minor self-limiting conditions if the medicine is used without medical supervision (for example the ADR (adverse drug reaction) profile needs a doctor to Traditional area of care New area of care assess risk–benefit,. or misdiagnosis might Medicine already OTC Medicine already OTC lead to the patient being put at risk); (dyspepsia treated with antacids) (hydrocortisone for eczema)

• The medicine is frequently used incorrectly leading to direct or indirect danger to health (for example, products liable to Traditional area of care New area of care misuse); Newly deregulated medicine Newly deregulated medicine (dyspepsia treated with H2 blocker or (simvastatin for hyperlipidaemia) • The activity of the drug or the side effects proton pump inhibitor) require further investigation; Chronic conditions

• The drug is parenterally administered. Based on Sue Kilby, Royal Pharmaceutical Society of Great Britain, personal communication.

Eurohealth Vol 14 No 3 20 HEALTH POLICY DEVELOPMENTS

Table 2: OTC availability in selected countries

Cimetidine Omeprazole Domperidone Metoclopramide Simvastatin

Austria OTC Rx Rx Rx Rx

Belgium Rx Rx OTC OTC Rx

Denmark OTC Rx Rx NR Rx

Finland Rx Rx NR Rx Rx

France OTC Rx Rx Rx Rx

Germany Rx Rx Rx Rx Rx

Greece Rx Rx Rx Rx Rx

Ireland Rx Rx OTC Rx Rx

Italy OTC Rx OTC OTC Rx

Netherlands OTC Rx OTC Rx Rx

Portugal Rx Rx Rx Rx Rx

Spain OTC Rx Rx Rx Rx

Sweden Rx OTC NR Rx Rx

UK OTC OTC OTC Rx OTC

Rx – Prescription only; OTC – available without a prescription; NR – not registered in that country.

Source: http://www.aesgp.be/Ingredients/EU-15Table.pdf

such a move in the UK are the deregu- community pharmacy also reflects the general move for pharmacists to be seen as lation of the Emergency Hormonal shifting balance of care from hospital to clinicians in their own right. In the UK, as Contraceptive pill (levonorgestrel) and the community. well as being able to sell a wider range of lipid lowering drug simvastatin (Figure 1). potent OTC medicines, they have also One of the other results of the changing increasingly acquired a right to supply paradigm of pharmacy has been the impact Implications for pharmacy practice medicines under the NHS, including OTC on the remuneration of pharmacists. In the As noted, whilst a large part of the products through mechanisms such as the UK, as in many other countries, pharma- rationale for deregulation came from the Minor Ailments Schemes, Patient Group ceutical remuneration has been tradi- industry and health policy makers, the Directors and direct prescribing rights. tionally linked to the volume of items pharmacy profession supported the move Further discussions of these are outwith dispensed against prescriptions. This was because it provided an opportunity for the scope of this paper, but are mentioned initially an appropriate basis, given the their members to use their skills more as an important illustration of how it is not skilled compounding required. However, fully. The professional pharmacy bodies possible to change one component of a as manufactured proprietary products have played a key role in the deregulation complex professional remit without became the norm, the professional contri- process which has contributed to the affecting other components. bution to the dispensing process, whilst paradigm shift of community pharmacists still a key component of a safe supply from a technical supply orientated role to European perspective process, in providing a final clinical check a more clinical cognitive role. Indeed, Whilst the detail of this paper is drawn on a medicine, became reduced. Other whilst some of the deregulation moves from experience in the UK it can be roles, such as general health care and were driven by the industry for specific regarded as a proxy for the rest of Europe. lifestyle advice, also were increasingly proprietary products, other moves for However, there are variations across delivered either out of goodwill for reasons deregulation of a general product have Europe despite initiatives to achieve a of professionalism, or formally paid for as come from the profession. This change in general harmonisation of pharmaceutical part of locally negotiated agreements. role to utilise the profession more fully in regulations. In most, if not all, countries Until recently, these were not remunerated an integrated health care service has been the concept of deregulation of medicines on a national basis. New contracts in the increasingly recognised in UK for OTC sale has been replicated although UK, introduced in the early 21st century Government policy papers since its early there are interesting differences in detail of have changed the basis for remuneration to mention in the publication of the Nuffield what is, and is not, available across the one which recognises these other non- report on pharmacy on 1986,5 culminating different countries as Table 2 illustrates. supply oriented services. in recent pharmacy strategies in the coun- This is despite the fact that the principles tries of the UK. The better use of Deregulation has contributed to this more of retaining a drug with a POM status are,

21 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS as previously stated, guided by European assistant is becoming professionalised. recommendations are made. This is not standards. However, in general, policy on Mandatory training has been in place since always easy. Use of algorithmic guidelines pharmacy and access to medicines is 1996, and more recently encouragement to summarising the necessary knowledge probably more visionary in the UK than become qualified as a pharmacy technician have been shown to be acceptable to and in most, if not all, other European coun- and registered with the RPSGB. popular with staff,11 but have not neces- tries. sarily supported evidence based product The role of pharmacists and their staff with supply.12 Other European differences include the respect to OTC medicines is therefore to exact nature of the POM, P and GSL cate- ensure, as far as possible, that medicines For some years a mnemonic WWHAM gories. In the UK and France, medicines in are sold within the conditions of the OTC (Who is the medicine for, What is the the P category can only be sold ‘under the licence (which may be more restricted than medicine for, How long have the supervision’ of a pharmacist from a regis- the indication for prescribed use), that the symptoms been present, Actions already tered pharmacy, but GSL products are potential for drug interactions (with both taken, Medicine taken for other reasons available from any retail outlet, including other OTC and prescribed medicines) is prescribed or otherwise) has been used as pharmacies. In Italy, the equivalent of P and assessed and avoided, and that people with an aide memoire to remind pharmacy staff GSL medicines exist as SOP (senza obligo contra-indications are not sold the prepa- of the generic questions to be asked, and di precizole) and PDB (prodotto di banco), rations. information needed to support every OTC but both are only available in pharmacies. sale. Whilst pharmacy staff state they use Using one of the most frequently sold The difference between the categories is the mnemonic and find it useful,13 in OTC drugs, ibuprofen, as an example, this that the GSL equivalent category, the PDB, practice not all the questions are routinely non steroidal, anti-inflammatory analgesic is available for customer self selection and asked.14 Where more questions are asked, should not be used long-term (more than can be advertised directly to the public. In the sale is more likely to be appropriate. seven days continually), should not be the Netherlands, as in USA, there are only Reasons often cited for not asking the used together with other non steroidal POM and OTC categories. Dutch questions included lack of customer recep- anti-inflammatory drugs or some anti- pharmacies focus much more on POM tiveness and time. hypertensive medications, and should not medicines and have a minority role in the be taken by people with a history of peptic There should therefore be a policy agenda sale of OTC products, 75% of which are ulcer disease or asthma. Whilst this appears to raise public awareness of the need to sold from ‘drogisten’ (chemists). These deceptively simple to deliver, in practice treat OTC medicines with respect. They intermediate outlets are neither registered we know that this guidance is not adhered must be reminded that, despite being pharmacies nor general retail outlets. to, as a long term follow up study of advertised to the public (in contrast to purchasers of ibuprofen7,8 and a general POM medicines in many countries Benefits and challenges of wider public survey9 showed (see next section). including the UK), OTC medicines are not availability of OTC medicines just an ordinary commodity, and that As noted earlier the rationale for deregu- The challenge therefore is to empower change in regulatory status from POM to lation of medicine is said to have been pharmacists and their staff to provide more P has not changed a drug or its potential to driven by government, the profession and directive advice to people buying medi- cause side effects. There is early research the industry. The success of deregulation cines, without compromising the prin- evidence which suggests that the public from these interlinked perspectives will ciples of increased public access to perceive OTC medicines to be safer and now be considered. medicines and public empowerment. Until less effective than POM medicines the recent rounds of deregulations, over From the government’s perspective dereg- (unpublished work by the author and the past twenty years, most of the drugs ulation is part of a philosophy to increase colleagues) which could explain the sold OTC did not have any body of safe and convenient access to medicines, current attitude of many of the public to published information to support evidence empower the public and encourage them giving information OTC. Mechanisms based use. Indeed, there is little evidence at to take greater responsibility for their own could build on the fact that when experi- all for many of the much hyped and adver- health. This is also part of a wider agenda encing symptoms of minor illness such as tised cough and cold remedies traditionally recognising that most people actually colds and flu the pharmacist is their first sold.10 This is not, however, the case for all 15 understand their own needs and symptoms preferred option for advice. OTC treatments, particularly the newly better than the professional and that the To what extent has deregulation increased deregulated products such as analgesics, best way to treat them is in partnership the market for medicines no longer products for gastrointestinal problems with the health care professionals. Thus, protected by patent and to what extent (antacids and antiulcer) and dermatological the ‘expert patient’ programme6 and medi- have costs shifted from the government to products. cines partnership initiatives (see the patient? Two of the early deregula- http://www.npc.co.uk/med_partnership) As with prescribed medicines, knowledge tions, loperamide and topical hydrocor- have emerged. Whilst the focus of the of all factors required for ‘safe’, clinically tisone, were said to have saved the UK former is more on prescribed medicines, effective supply does not necessarily NHS £4.2 million and £2 million per the latter encompasses both prescribed and translate into practice. For OTC sales the annum respectively in 1987.16 Similar OTC medicines, and for OTC medicines pharmacy staff (pharmacists and non- Swedish research estimated that the dereg- sold from pharmacies the health profes- pharmacists) must have all the knowledge, ulation of sixteen different products had sional who provides the advice and they must be able to communicate it to the saved $400 million per annum.17 However, guidance is the pharmacist, or the purchaser and also obtain information it is not possible to generalise across all pharmacy assistant. Increasingly in the UK from the purchaser on relevant medical drugs from this data, as each product will the previously untrained pharmacy history to ensure appropriate management be different.

Eurohealth Vol 14 No 3 22 HEALTH POLICY DEVELOPMENTS

For example, consider a product for an treatment carbaryl. Moreover, as already At present in the UK the main system of acute condition, such as topical acyclovir noted, once a medicine is badged P or pharmacovigilance, the Yellow Card for the treatment of cold sores (herpes and GSL, there is emerging evidence that the System (http://yellowcard.mhra.gov.uk/ simplex). This was deregulated in 1993, public no longer respect its potency in the the-yellow-card-scheme), only requires all and routine data indicate that prescriptions same way that they would if it were a adverse events to be reported for newly for this product fell sharply and remained POM medicine. It is therefore no wonder launched medicines; only life threatening low.18 Thus supply was changed from that after purchase of a P or GSL medicine, events are invited for established medi- NHS supply to OTC supply. In contrast, a significant number of purchasers use it cines. As more medicines are deregulated this drop in prescribed volume was not outwith the conditions of the OTC license it may be necessary to change these criteria observed for the anti-ulcer H2 blockers, as described below. so that unacceptable prevalence levels of such as cimetidine, famotidine and unpleasant, but not severe, side effects are Drug safety depends on appropriate use rantidine. It is suggested that OTC avail- detected. This requires public and profes- (i.e. at the right dosage, for the right indi- sional campaigns. Whilst there is a danger ability widened the target population, and cation, and in the absence of contraindica- of overwhelming the routine pharma- that people transferred from self-treatment tions), and knowledge of the adverse event covigilance system, increased automation of dyspepsia with simple cheap antacids to profile of the drug and its interactions. in reporting (for example on-line) and the more expensive newer products. Long term follow up studies of improved analysis should mean this can be However, once realising their effectiveness, purchasers/users of ibuprofen (a proxy for accommodated. A problem with the signal long term use was translated back into other OTC drugs) shows that if these generation system which depends on increased prescription use. Thus, in this criteria are applied there maybe cause for spontaneous reporting is that the reporter instance, the overall market increased concern.7,8 The current OTC dosage is has to make the association between the probably in both the NHS and self care 1–2g ibuprofen daily, in divided doses, for drug (the cause) and the effect, before arena. This pattern has also seen observed a maximum of seven days, yet this study 19 thinking of reporting it. Once again the with antihistamines. Economic found that 38% of purchasers/users (who perceived safety of OTC medicines modelling based on consumer surplus also responded to the study questionnaire) becomes an issue and people, both profes- provides theoretical understanding of the were taking it for chronic conditions sional and the public need to be reminded above observed effects. If the acquisition (defined as having been experienced for that today’s OTC drug was yesterday’s cost of the drug is cheaper over the counter more than thirteen weeks). Nearly a prescription speciality. there will be financial benefits for both quarter had been using ibuprofen regularly 20,21 patient and government. for more than eight weeks, 8% had In prescription drug monitoring, dedicated exceeded the maximum OTC daily dose follow up exercises are an alternative Disadvantages of deregulation (and 1% the maximum prescribed dose). method of pharmacovigilance using Whilst the deregulation of medicines has People were, in general, using it for appro- routinely held records to identify people many benefits, as already outlined, there priate conditions but not in the absence of who have taken a drug and then reviewing are also some disadvantages. It is contraindications. 4% had a history of records for any evidence of side effect or important to be aware of and address these stomach ulcer, 7% a history of asthma, 4% drug interactions. However as no records issues, rather than allowing them to ulti- had sought advice about gastro-intestinal are routinely kept of medicines supplied mately result in reversal of the policy. symptoms during the week after purchase, OTC this is not possible, other than as a Firstly, side effects and adverse events from 7% were using concurrently with a gastro- dedicated follow up exercise, such as the medicines are an important and well recog- intestinal medicine and 4% with an asthma ibuprofen and hayfever follow up studies 7,19,22 nised consequence of the pharmacological medicine. Finally 38% were using it with a reported above, and similar. medicine with a potential for interaction: activity of a drug. Although the licensing So, the lack of record keeping of OTC 27% with another analgesic, 11% with an procedures include requirements for purchases is a problem, and one which it antihypertensive and 8% with a diuretic. evidence of safety in the context of use, it may be hard to resolve. Although in the is only once a medicine is used by people Ways to avoid these drug interactions need UK, where community pharmacies are in that context that ‘real world’ circum- to be considered, such as enhanced NHS increasingly being linked to NHS IT stances apply. Thus whilst newly launched record keeping, access for pharmacists to systems, a future mechanism to link OTC POM medicines are deemed safe on the selected parts of the medical records, and purchases to a single patient record is tech- basis of the pre-launch clinical trial data, it increased public and professional nically possible, this is not the case for all is often only after product launch, and use awareness. So whilst most OTCs probably countries and/or for GSL medicines sold by larger numbers of people with a range are theoretically safe, we need to be sure from non-pharmacy outlets. Again, as IT of co-morbidities and taking concurrent that this is the case in practice, and have develops, it may ultimately be possible to medication, that rare but potentially fatal systems in place to prove this. We also automate this, with individual purchaser side effects are identified. need to consider whether the level of side consent, for example, through bar coding effects experienced is commensurate with and swipe cards. This is likewise the case when a medicine is the benefit. A side effect profile which is deregulated from POM to P and is used by Finally, making medicines available over acceptable for a treatment which prolongs an even wider range of people, without the the counter is inextricably linked to private life in advanced cancer will be quite individualised, normal medical advice that purchase and therefore is an inequitable different from one for a lifestyle medicine. would have supported prescription use. policy. Whilst there are cheaper ‘value for Examples of medicines subsequently Pharmacovigilance systems, designed to money’ equivalents of well established needing to be reclassified include the anti- monitor and identify side effects also need medicines such as paracetamol available for histamine terfinadine and the anti head lice to take these different criteria into account. OTC purchase this is not the case for the

23 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS newer deregulated medicines. Thus, those availability. New England Journal of 15. Porteous T, Ryan M, Bond C, who are less affluent are disadvan- Medicine 2001;13;345:810–16. Hannaford P. Preferences for self-care or 23–24 consulting a health professional in minor taged. 3. Bond CM, Sinclair HK, Taylor RJ, illness; a discrete choice experiment British Winfield AJ. Community pharmacists’ A national initiative to address this has Journal of General Practice 2006;911–17. recently been introduced in Scotland, attitudes to the deregulation of medicines 16. Ryan M, Yule B. Switching drugs from based on earlier research in England25 as and to their extended role. International Journal of Pharmacy Practice 1993;2:26–30. prescription-only to over-the-counter part of a revised community pharmacy availability: economic benefits in the contractual framework. In this new 4. Sihvo S, Hemminki E, Ahonen R. United Kingdom. Health Policy Physicians’ attitudes toward reclassifying framework a Minor Ailment Service 1990;16:233–39. (MAS) is one of the four core services drugs as over-the-counter. Medical Care delivered by all community pharmacies. 1999;37(5):518–25. 17. Carlsten A, Wennberg M, Bergendal L J. The influence of Rx-to-OTC changes on People, who would normally be exempt 5. Nuffield Foundation. Nuffield drug sales. Experiences from Sweden from prescription charges (on the grounds Pharmacy: A Report to the Nuffield 1980–1994. Clinical Pharmaceutical of income, age or morbidity) can access, Foundation. London: Nuffield Foundation, Therapy 1996;21(6):423–30. free of charge on the NHS, a range of 1986. 18. Bond CM. Prescribing in Community OTC medicines from the pharmacy. This 6. Department of Health. The Expert Pharmacy: Barriers and Opportunities. therefore removes the inequity of access Patient: A New Approach to Chronic introduced by private purchase but runs PhD thesis. Aberdeen: University of Disease Management for the 21st Century. Aberdeen, 1995. counter to any cost shifting from the London: Department of Health, 2001. public to the private purse. The MAS 19. Sinclair H, Bond C, Largue G, Price D, 7. Sinclair HK, Bond CM, Hannaford PC. scheme has been carefully developed and Hannaford P. Community pharmacy Long term follow up studies of users of includes computerised registration of the provision of allergic rhinitis treatments: a non-prescription medicines purchased longitudinal study of patient reported patient at a particular pharmacy with NHS from community pharmacies: some records maintained containing the patient’s outcomes. International Journal of methodological issues. Drug Safety Pharmacy Practice 2006;13:249–56. unique NHS identification number (the 2001;24(12):929–39. CHI – Community Health Index). A 20. Ryan M, Bond CM. Dispensing doctors 8. Sinclair HK, Bond CM, Hannaford PC. current shortcoming of the system is that it and prescribing pharmacists Pharmaco- Over the counter ibuprofen: how and why does not link to other health records, such economics 1994;5(1):8–17. is it used? International Journal of as the general practitioner (GP) held Pharmacy Practice 2000;8;121–7. 21. Shih YC, Prasad M, Luce BR. The medical record, although there are longer effect on social welfare of a switch of term plans to address this. Therefore, in 9. Porteous T, Bond CM, Hannaford P, second-generation antihistamines from the short term GPs need to continue to Sinclair H. How and why are non- prescription to over-the-counter status: a remember to ask about, and patients need prescription analgesics used in Scotland? microeconomic analysis. Clinical Therapy Family Practice 2005;22:78–85. to report, use of OTC medicines. At the 2002;24(4):701–16. 26 moment this does not always happen. 10. Schroeder K, Fahey T, Systematic 22. Stewart D, Helms P, McCaig D, Bond review of randomised controlled trials of C, McLay J. Monitoring adverse drug Conclusion over the counter cough medicines for acute reactions in children using community Recent moves have increased the range of cough in adults. British Medical Journal pharmacies: a pilot study. British Journal of medicines available without a prescription. 2002; 324:329–32. Clinical Pharmacology 2005;59:677–83. This move has potential benefits for all 11. Bond CM, Grimshaw JM, Taylor RJ, 23. Schafheutle E, Cantrill J, Nicolson M, stakeholders. However for these benefits Winfield AJ. An evaluation of clinical Noyce P. Insights into the choice between to be fully realised issues of record guidelines for community pharmacy. self medication and a doctor’s prescription: keeping, pharmacovigilance and public and Journal Social and Administrative a study of hay fever sufferers. International professional attitudes all need to be Pharmacy 1998;15(1):33–39. Journal of Pharmaceutical Practice resolved. Whilst many of the potential 12. Watson MC, Bond CM, Grimshaw JM, 1996;4:156–61. risks can be contained within a pharmacy Mollison J, Ludbrook A, Walker AE. 24. Payne K, Ryan-Woolley B, Noyce P. environment, this is more complex in a Educational strategies to promote evidence Role of consumer attributes in predicting general retail environment, and in coun- based community pharmacy practice: a the uptake of medicines deregulation and tries where the P and GSL categories are cluster randomised trial (RCT). Family National Health Service prescribing in the distinct, the secondary stage of deregu- Practice 2002;19:529–36. United Kingdom. International Journal of lation from P to GSL should be considered 13. Watson MC, Bond CM. The evidence Pharmaceutical Practice 1998;6:150–58. extremely carefully. based supply of non-prescription 25. Whittington Z, Cantrill J, Hassell KJ, medicines: barriers and beliefs. Batres F, Noyce P. Community pharmacy International Journal of Pharmacy Practice management of minor conditions – the 2004;12:65–72. ‘Care at the Chemist’ scheme. The REFERENCES Pharmaceutical Journal 2001;266:425–28. 14. Watson M, Bond C, Grimshaw J, 1. Dudley J. OTC Distribution in Europe. Johnston M. Factors affecting the guideline 26. Urquhart G, Sinclair HK, Hannaford Kidderminster: James Dudley compliant supply (or non supply) of non- PC. The use of non-prescription medicines International, 2007. prescription medicines in the community by general practitioner attendees. 2. Brass EP. Changing the status of drugs pharmacy setting. Quality and Safety in Pharmacoepidemiology and Drug Safety from prescription to over-the-counter Health Care 2006;15:5307. 2004;13:773–79.

Eurohealth Vol 14 No 3 24 HEALTH POLICY DEVELOPMENTS Development and use of the Japanese case-mix system

Shinya Matsuda, Kohichi B Ishikawa, Kazuaki Kuwabara, Kenji Fujimori, Kiyohide Fushimi and Hideki Hashimoto

Summary: The Japanese government introduced a case-mix system, known as the Diagnostic Procedures Combination (DPC), for acute care hospitals in 2003. Covering more than 90% of acute in-patient care, it has become one of the important sources of information for health policy. Using this dataset, the authors have analysed the impact on chemotherapy regimens.

Keywords: Case-mix, Diagnostic Resource Groups, Chemotherapy, Japan

Japan has a Bismarck-type compulsory company determines the insurance fund in been continuing discussion over several social health insurance system.1 The which they are enrolled and the level of decades on how to contain these costs. universal system, which covers 122 million contributions that they must make. The While payers argue that costs are exhor- people, is divided up according to type of self employed and retired are covered by a bitant, service providers insist that the employment and place of residence. community-based health insurance government does not allocate enough Although thousands of independent scheme. resources to services, pointing to the rela- insurance funds exist, they are all inte- tively low level of health care expenditure, The Japanese health financing system has grated within a government mandated 8% of GDP in 2004, compared with 8.3%, long been based upon fee-for-service (FFS) framework. For employees, the type of 10.6%, 10.9% and 15.3% in the UK, reimbursement using a national price France, Germany and the USA respec- schedule. The health insurance funds, both tively.2 One ongoing problem is the lack of Shinya Matsuda is based at the public and semi-public, gather premiums transparency in service provision, Department of Preventive Medicine and from their members and reimburse the including a lack of appropriate data to Community Health, University of costs of treatment according to type and evaluate medical services. Occupational and Environmental Health, volume of services provided (Figure 1). Japan. As the health system has been based on a Health care expenditure in Japan has fine tuned FFS system, there are little Kohichi B Ishikawa is based at the steadily increased (Table 1), and there has Statistics and Cancer Control Division, National Cancer Center. Figure 1: Structure of social health insurance scheme in Japan Kazuaki Kuwabara is based at the Department of Health Care Adminis- tration and Management, Graduate payment School of Medical Sciences, Kyushu National Organisation for University. government Insurer review and payment Kenji Fujimori is based at the Division of demand with claim Medical Management, Hokkaido subsidy University Hospital. Kiyohide Fushimi is based at the demand payment Department of Health Policy and contribution with Informatics, Tokyo Medical and Dental claim University Graduate School of Medicine. medical services Hideki Hashimoto is based at the Department of Health Economics and Insured Medical facilities Epidemiology Research, School of Public Health, Tokyo University. co-payment (10–30%) Email: [email protected]

25 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS

Table 1: Trends in total health care expenditure in Japan

Total health care expenditure (THE) National income (NI) TME/NI Total health care expenditure for older people

Total Rate of Per capita Total Rate of (%) Total Rate of Per capita TME for older (billion yen) increase (000s yen) (billion yen) increase (billion yen) increase (000s yen) people/TME (%) (%) (%) (%)

1955 238.8 2.7 6,973.3 3.4

1965 1,122.4 19.5 11.4 26,827.0 11.5 4.2

1975 6,477.9 20.4 57.9 123,990.7 10.2 5.2 866.6 30.3 184 13.4

1985 16,015.9 6.1 132.3 261,089.0 7.4 6.1 4,067.3 12.7 499 25.4

1995 26,957.7 4.5 214.7 374,277.5 0.1 7.2 8,915.2 9.3 752 33.1

1996 28,454.2 5.6 226.1 386,793.7 3.3 7.4 9,723.2 9.1 782 34.2

1997 28,914.9 1.6 229.2 391,341.1 1.2 7.4 10,278.6 5.7 790 35.5

1998 29,582.3 2.3 233.9 379,264.4 3.1 7.8 10,893.2 6.0 801 36.8

1999 30,701.9 3.8 242.3 373,340.3 1.6 8.2 11,804.0 8.4 832 38.4

2000 30,141.8 1.8 237.5 379,065.9 1.5 8.0 11,199.7 5.1 758 37.2

2001 31,099.8 3.2 244.3 368,374.2 2.8 8.4 11,656.0 4.1 757 37.5

2002 30,950.7 0.5 242.9 362,118.3 1.7 8.5 11,730.0 0.6 737 37.9

2003 31,537.5 1.9 247.1 368,659.1 1.8 8.6 11,652.3 0.7 753 36.9 detailed claim data, containing information patterns by the physicians association. number of specific indications are listed, such as diagnosis, procedures conducted, They did however acknowledge the for example, ‘Malignant neoplasm of drugs prescribed etc. Claims data have not necessity of case-mix profiling as a tool to Trachea (C33)’ or ‘Carcinoma in situ of been standardised or coded electronically, improve transparency. It was therefore bronchus and lung (D022)’. After consul- limiting their use in health policy making. decided to develop an original classifi- tation with an expert panel on typical One key objective of the new case-mix cation system that fits with practice procedures for each diagnosis, as well as system (DPC – Diagnostic Procedures patterns in Japan, while allowing compar- potential co-morbidities and complica- Combination) is to implement a stan- ative benchmarking nationwide and with tions, the research team constructed the dardised electronic claim system, with systems in other countries. DPC groups. keywords that provide transparency and In the DPC algorithm, diagnosis, accountability. In future, it should be The use of DRGs in eight western procedure, and co-morbidity/compli- possible to evaluate the cost and quality of European countries was also investigated. cation are the three key variables for clas- medical services. This article, explores how As a result it was decided to develop the sification. Additional information (for the new DPC can be a tool for greater new case-mix system as a profiling tool for example, birth weight in the case of transparency in the provision of medical medical services in line with the principles neonatal intensive care) is also referred to services. of the Dutch Diagnose Behandeling Combinatie (DBC). Also of great in some groups. Diagnosis and co- morbidity/complications were coded Case-mix system development influence were the French and Austrian using the International Classification of From the late 1990s, the Ministry of approaches to case-mix applications for Disease Version 10 (ICD10) scheme, with Health, Labour and Welfare (MHLW) and regional health planning, and the Belgian procedures coded in the Japanese its affiliated research institute, the Institute and English approaches towards the incre- Procedure Code, as defined in the fee of Health Economics and Policy (IHEP) mental development process. schedule of the national health insurance explored the feasibility of introducing a system. case-mix classification system as a tool of The structure of DPC standardised medical profiling and The DPC Project team made use of a The structure of DPC version 3 has eight payment. A number of case mix systems DBC-like data gathering process and a components (Figure 2). This includes the were tested for validity. While some US PMC (Patient Management Category)-like Major Diagnosis Category (MDC) and Diagnostic Related Group systems were severity setting.3 The first step in devel- DPC serial number (DX) corresponding thought to be applicable to Japanese acute- opment was to construct a definition table to ICD10 category, which indicates the care hospitals, they were criticised as being (see Table 2). For the diagnostic category type of admission. It should be noted these too rough to correctly reflect practice ‘Malignancy, Respiratory System’ a components are for profiling, and not all

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Table 2: Example of DPC definition table – Malignancy, respiratory system

Base Principal diagnosis Principal surgery Additional surgery Adjuvant therapy Co-morbidity/ DPC complication

Diagnosis ICD Procedure JPC * Code Procedure JPC Code Procedure JPC Code Diagnosis DPC6/ ICD10

Malignant C33 No 99 Bronchoscopy, D301 01 Chemotherapy 04 Brain tumor 010010 neoplasm of procedure rigid without trachea radiation *

Malignant C34$ Other 97 Bronchoscopy, D302 01 Chemotherapy 03 Respiratory 040130 neoplasm of procedure flexible with radiation failure bronchus and lung

Secondary C780 Lobectomy K511$ 01 Needle D412 01 Radiation 02 Malignancy 070040

Malignancy, respiratory system malignant biopsy without neoplasm chemotherapy of lung

Carcinoma D021 Lobectomy, K513 01 Thoracotomy D415 01 Hemodialysis J0382 01 Disorder, 130070 in situ of trachea endoscopic leucocyte

Carcinoma D022 Tracheostomy K5182 01 CVI G005 01 Chronic R522 in situ of bronchus pain and lung

Carcinoma in situ D024 Lung cancer K514$ 01 Respirator J045$ 01 of respiratory procedure system, unknown Lung cancer K514- 01 procedure, 2$ endoscopic

*: JPC = Japan Procedure Code **: For chemotherapy, there is a special list in which a specific MHLW code is allocated to each drug.

Figure 2: Structure of DPC code are necessarily for the reimbursement schedule.

04 0040 x x 01 x 4 x x DPC Reimbursement Scheme The DPC based reimbursement scheme is 04 MDC quite different to that in other countries. Payment to hospitals has both a DPC 0040 Code for Dx component and a FFS component. The x Type of admission DPC component relates to the hospital fee, comprising hotel fee and costs incurred in x Age, birth weight, Japan Coma Scale hospital wards for pharmaceuticals, supplies and diagnostic procedures 01 Sub-code for principal surgical 01 etc: code for surgical procedure in definition table cheaper than 10,000 Yen (US$10). The FFS procedures 99: no surgical procedure component refers to tariffs for surgical procedures and anaesthesia, pharmaceu- x Sub-code for additional surgical 0: none ticals and expensive devices used in oper- procedures 1: exist ating rooms, and procedures of more than 4 Sub-code for adjuvant therapy 0: none 10,000 Yen. For the DPC component, a 1 etc: code for adjuvant procedures per diem payment schedule is set for each DPC group. x Sub-code for CC 0: none 1: exist Figure 3 provides an example of a DPC payment. For each DPC grouping, the x Sub-code for severity standard per diem payment is defined, and three periods are set for reimbursement: x = not applicable period I, period II and ‘upper limit’ for

27 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS

Table 3: Top ten chemotherapy regimens for lung cancer in Japanese hospitals (2006)

Share of total Share of total cases Cumulative share of Regimen Number of hospitals Cases hospitals (%) (%) cases %

1 carboplatin + paclitaxel 189 78.1% 3243 18.9% 18.9%

2 Gefitinib 186 76.9% 1164 6.8% 25.6%

3 etoposide + carboplatin 166 68.6% 1069 6.2% 31.8%

4 docetaxel hydrate 148 61.2% 906 5.3% 37.1%

5 cisplatin + irinotecan 123 50.8% 652 3.8% 40.9%

6 carboplatin + gemcitabine 114 47.1% 585 3.4% 44.3%

7 etoposide + cisplatin 105 43.4% 560 3.3% 47.6%

8 cisplatin + vinorelbine 85 35.1% 544 3.2% 50.7%

9 Amrubicin 117 48.3% 540 3.1% 53.9%

10 carboplatin + docetaxel hydrate 79 32.6% 510 3.0% 56.8%

DPC-based payment. These periods are Figure 3: Example of DPC-based payment for hospital linked to average length of stay. In period I, per diem payment is set for 50% more DPC 040040xx01x4xx (Malignacy, Respiratory system, lebectomy and/or tracheostomy than the standard per-diem payment. (including endoscopic). Chemotherapy without radiation. No CC) Furthermore, the hospital coefficient is calculated for each facility according to its function and characteristics. From period II to the upper limit day, per diem payment 3129 points is set at 15% less than the standard payment. Over the upper limit day a reduced FFS payment scheme will be applied. The system has been fully 2320 points computerised given its complex nature, including special computerised software 1572 points for ICD coding to aid clinicians completing DPC information sheets for Points per diem their patients. Special fixed fee 2SD Making use of the DPC database for health policy Cancer has been a leading cause of death in Japan, with one person in three dying from Period I Period II Upper limit for 180 days the disease. More people are dying of (16 days) (31 days) DPC-based payment cancer as the population gets older. (62 days) Combating cancer is an increasingly serious issue for health policy makers. requires analysis of the current use of and October 2006.5 The data indicates that However, analysts have criticised the wide treatments – something that can now be 17,200 lung cancer patients received variations in the accessibility and quality achieved making use of DPC data. This chemotherapy using 659 different of cancer care among the different regions can help facilitate a movement towards regimens, with the most frequently applied and institutions. In order to further greater use of evidence based medicine and regimen being carboplatin plus paclitaxel, ameliorate cancer, the MHLW established quality assurance in cancer care. which was used by 3,243 patients in 189 a ‘Comprehensive Ten-Year Strategy for hospitals. The same data set was also used Cancer Control’ in 2006. One of the most Table 3 shows, ten of the thirty most to identify frequency of drug use in lung important objectives of the Strategy is to widely regimens used for chemotherapy in cancer patients (Table 4). Carboplatin was assure the equal access to quality cancer lung cancer patients in 242 acute care the most frequently used drug: 6,754 cases treatment for the entire population. This hospitals in the DPC system between July

Eurohealth Vol 14 No 3 28 HEALTH POLICY DEVELOPMENTS

Table 4: Top fifteen chemotherapy drugs for lung cancer in Japanese hospitals (2006)

Drug Number of Percentage by Number of cases Percentage by Number of used Percentage by hospitals hospital case regimens used regimens

1 carboplatin 219 90.5% 6,754 39.3% 216 32.8%

2 paclitaxel 195 80.6% 4,014 23.3% 130 19.7%

3 cisplatin 189 78.1% 3,369 19.6% 199 30.2%

4 gemcitabine 190 78.5% 2,333 13.6% 124 18.8%

5 docetaxel hydrate 187 77.3% 2,227 12.9% 117 17.8%

6 vinorelbine 181 74.8% 2,098 12.2% 103 15.6%

7 irinotecan 192 79.3% 1,807 10.5% 95 14.4%

8 etoposide 185 76.4% 1,801 10.5% 57 8.6%

9 gefitinib 194 80.2% 1,548 9.0% 95 14.4%

10 OK-432 183 75.6% 788 4.6% 119 18.1%

11 vinorelbine 150 62.0% 722 4.2% 77 11.7%

12 5-fluorouracil 135 55.8% 709 4.1% 41 6.2%

13 amrubicin 130 53.7% 677 3.9% 34 5.2%

14 levofolinate 98 40.5% 590 3.4% 11 1.7%

15 nedaplatin 30 12.4% 465 2.7% 28 4.2%

Total 242 100.0% 17,200 100.0% 659 100.0%

(39.3%), followed by paclitaxel (23.3%) Figure 4: Example of DPC based clinical study Lung cancer, chemotherapy (040040xx01x4xx) and cisplatin (19.6%). Among the 659 regimens, 216 regimens contain carbo- Outcome reearch for lung cancer, small cell platin (32.8%), 199 regimens contain • cisplatin - irinotecan cisplatin (30.2%) and 130 contain pacli- • cisplatin + etoposide taxel (19.7%). This indicates that carbo- National DPC platin and cisplatin are the main elements database of chemotherapy for lung cancer in Japan.5

Conclusion Extraction of posible cases Today the DPC programme covers more than 90% of acute in-patient care, including cancer, cardio-vascular disease Large scale multi-centre and injuries. In 2007, 1,426 hospitals Hospital C post-marketing clinical study participated in the DPC programme, Hospital B covering approximately 450,000 acute care Survival study beds. It was expected that another 200 Hospital A Cost Effectiveness Analysis Cost Utility Analysis hospitals would join the project in 2008. Hospital Cost Benefit Analysis The same methodology, using the DPC database other health reearch framework, is now being applied to out- Additional patient services.6 This implies that use of information Extraction of the DPC database, can allow one to possible cases analyse the whole process of treatment from a clinical and economic viewpoint.

29 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS

The DPC database can also be used for large-scale multi-central post-marketing e-Health in Canada: clinical studies as shown in Figure 4. In 2008, the DPC research programme has clinical studies for several disorders, Lessons for European health including chemotherapy for lung and breast cancer. systems With limited resources available in the health sector, not all medical innovations can be covered by the public medical insurance scheme. In order to make the Japanese health system sustainable, evidence for the rational distribution of Denis Protti resources is needed. This requires infor- mation about medical procedures and Summary: This paper provides a status report of health information their outcomes. technology and electronic health record (EHR) initiatives in Canada. It As the English National Health Service also candidly discusses the difficulties Canada is facing in moving the EHR experience has shown, under-financing of agenda forward. Particular emphasis is placed on describing the unique the health sector can damage the health role of Canada Health Infoway, a unique, federally-funded, independent, system. On the other hand, over-financing not-for-profit organisation whose members are Canada’s fourteen federal, the health system can damage the general provincial and territorial Deputy Ministers of Health. The interesting economy, because the Japanese health system depends on contributions from the lesson learned is about a national organisation being successful in an general economy. Thus, there needs to be environment whereby health care is a provincial responsibility. a balance between the health spending and the needs of the broader economy. Key words: Electronic Health Records, Funding Health IT, National Oversight, Electronic Medical Records, Canada The new DPC system can help provide detailed situation analysis of the use of health care interventions among regions, in-patient and out-patient services, as well Perhaps the single most potent lesson for health care and it is only recently that as between acute and chronic care. At its other countries to learn from Canada is its governments have begun to realise that heart are the concepts of transparency and unique, federally-funded, independent, technology can improve the quality of care accountability. By using this framework, not-for-profit organisation called Canada and actually save money in the long run. researchers will in future be able to Health Infoway (Infoway) whose As a strategic investor, Infoway works in evaluate the quality of the health system members are Canada’s fourteen federal, collaboration with health ministries, from both micro and macro perspectives. provincial and territorial Deputy Ministers regional authorities, other health care of Health. Created in 2001, Infoway organisations and information system invests in a common, pan-Canadian vendors to best align Infoway’s invest- REFERENCES framework of electronic health record ments with jurisdictional plans and to systems where best practices and 1. Matsuda S. Health Insurance System in leverage existing solutions. Once successful projects in one region can be Japan. Journal of Economics and Medicine investment decisions are made, public 2004;22:15–25. shared or replicated in another. Infoway is sector partners lead the development and Canada’s catalyst for collaborative change 2. OECD. OECD Health Data 2006. implementation of EHR solutions. to accelerate the use of electronic health Paris: OECD, 2006. Infoway views an EHR as a secure and information systems and electronic health private lifetime record of an individual’s 3. Young WW, Kohler S, Macioce DP. records (EHRs) across the country. It Patient Management Categories, Release health and care history. Available electron- recognises and has to function in an envi- 5.0. Pittsburgh: The Pittsburgh Research ically, it provides authorised health care ronment whereby health care is a Institute, 1992. professionals with immediate access to provincial responsibility. 4. Ministry of Health, Labour and Welfare. their patients’ accurate health histories, DPC Definition Table 2004. Tokyo: As in many countries, though the health including laboratory and radiology test MHLW, 2004. care sector depends upon accurate, up-to- results, past treatments, prescription drug date information, it has been slow to profiles and immunisations, while 5. Ishikawa BK, Matsuda S. Report of the exploit information technology (IT) – protecting privacy and confidentiality. The 2004 Study on the Cost Estimation of mainly because of cost and resistance to EHR supports improved clinical decision- Medical Services by Case-mix (suppl. 5) DPC portfolio for chemotherapy change. For years, IT was a low priority in making leading to more effective diagnosis regimens, 2005. (in Japanese). and treatment, greater patient safety, increased efficiency and improved access Denis Protti is Professor, School of Health 6. Matsuda S, Ishikawa BK, Kuwabara K to services. et al. Report of the 2006 Study on the Cost Information Science, University of Estimation of Medical Services by Case- Victoria, British Columbia, Canada. It is worth noting that in Canada, a mix, 2007. (in Japanese). Email: [email protected] distinction is made between the above

Eurohealth Vol 14 No 3 30 HEALTH POLICY DEVELOPMENTS

Table 1: Projects that have received Infoway funding At a hospital level, the University Health Network (UHN), a large teaching hospital Area Completed projects Active projects on three sites in Toronto has successfully implemented CPOE (computerised Infostructure 14 10 physician order entry) including over 50,000 medication orders a month – an Provincial client and provider registries 12 17 application most hospitals in North Provincial drug information systems 8 11 America have been unable to address at this point in time. As a result, UHN has Provincial laboratory information systems 3 4 been able to demonstrate a reduction in medication errors and adverse drug events. Regional diagnostic imaging systems 12 17 At a local level, patients at the Group Telehealth 30 41 Health Centre’s in Sault Ste. Marie, Ontario have been invited to participate in Public health surveillance 2 12 EMRxtra, a project supported by a $2 Interoperable EHRs 7 19 million investment by Infoway. With the patients’ consent, EMRxtra extends the Innovation and adoption 9 26 centre’s electronic medical records to local pharmacists and members of the larger, 1 Source: Canada Health Infoway, 2007. multi-disciplinary team of care providers. Access to lab results, allergies and other defined EHR and an electronic medical registries, twelve have been completed and vital information contained in the elec- record (EMR). An EMR generally refers seventeen are active. It should be noted tronic medical record helps pharmacists to computer-based clinical data of an indi- however that the information in Table 1 is avoid dangerous drug interactions and vidual that is location specific and kept by not an account of all the projects underway provide sound advice to the patient with a single physician office or practice, in Canada but only those that have the confidence that comes from being fully community health centre, or possibly an received Infoway funding. informed about the patient’s medical ambulatory clinic. Ideally, the two work As in most countries, Canada can point to history. Just as importantly, the phar- together, with doctors’ EMRs connected its centres of excellence and its crown macist’s expertise becomes an important to wider EHR systems. Infoway’s goal is jewels so to speak. A few of many element in the circle of care provided to the that by 2010, 50% of Canadians (and examples at the provincial level are British patient. 100% by 2016) will have their electronic Columbia’s PharmaNet system which health record available to those authorised since 1995, have connected all the phar- The less good news professionals who provide their health care macies in the province to a centralised The absence of additional funding in the services. medication profile database. As a result, Government of Canada’s 2008 Budget puts any pharmacy and hospital emergency the 2010 goal of providing 50% of The good news department in the province has 24/7 access Canadians with an EHR at risk. Infoway Working with its federal, provincial and to all the medications any patient has will need significant additional capital to territorial partners, Infoway is attempting received in the previous fourteen months. provide the benefits of EHRs to all Cana- to hasten the pace of development and An Infoway sponsored project will soon dians and across the continuum of care as implementation of electronic health give that same access to physicians who recommended in the 2006 Health Council records. During 2007–08, Infoway have EMR systems in their offices. of Canada Annual Report to Canadians. approved $311.5 million in new projects, Two studies estimated the ten year total bringing the total cumulative value of its At a regional level, the Capital Health cost of ownership for the pan-Canadian investments to $1.457 billion or 89% of Authority based in Edmonton, Alberta interoperable EHRs at approximately $10 Infoway’s $1.6 billion in capitalisation by had ‘islands’ of patient information until billion, with a return of $6 to $7 billion a the federal government. This capitalisation April 2004. After only eleven months in year in efficiencies when fully imple- includes an injection of $400 million that development, Capital Health launched mented.2,3 An estimated investment of Infoway was allocated by the Government netCARE, Canada’s first region-wide inte- $350 per person, spread over ten years, is of Canada in the March 2007 Budget for grated EHR. For the first time, authorised needed. This is consistent with what other investment in electronic health infor- clinicians had immediate computer access developed countries have invested. mation and communications technology. to up-to-date patient records across systems. The creation of the netCARE In addition to the funding issue, a 2006 The investments have brought the total portal required managers to consider the study by the Commonwealth Fund found number of projects underway to 254, most efficient use of resources, how to that only 23% per cent of Canadian representing a four-fold increase from the safeguard patient confidentiality and, in doctors use electronic medical records, fifty-three projects that were underway in particular, how to engage with the clini- compared with 98% in the Netherlands, 2004.1 For instance, in terms of Infos- cians who would ultimately use it. With 92% in New Zealand and 89% in the tructure, there are twenty-four pan- 4 the success of the netCARE portal, the United Kingdom. The seven-country Canadian projects of which fourteen have Alberta Government has selected it as the survey revealed strikingly different been completed and ten are active while in platform for a province-wide EHR. country rates of primary care practice use terms of provincial client and provider of IT and the range of functions supported

31 Eurohealth Vol 14 No 3 HEALTH POLICY DEVELOPMENTS by office systems. Primary care doctors in tional partners to develop and share the short, beyond better health care, all Australia, the Netherlands, New Zealand long-term health infostructure vision for provinces and territories are reaping and the United Kingdom have the most Canada. They have facilitated national economic benefits from their EHR widespread and multifunctional systems; collaboration to ensure that public and projects. Canadian and US doctors lag well behind. private sector stakeholders jointly plan, Some progress has been made since the share best practices and continually 2006 study, particularly in the province of improve the deployment of the pan- REFERENCES Alberta due to the government’s early Canadian health infostructure. Effective 1. EHRnews@Infoway. Spring/Summer decision to provide financial support to its alliances with the private sector have 2008. Montreal: Canada Health Infoway, physicians. helped Infoway better leverage its 2008. Available at http://www.infoway- investment dollars, and better align the It seems a key problem is that the cost of inforoute.ca/Admin/Upload/Dev/ information technology industry’s Document/EHRNews_SS2008_EN.pdf EMRs in a Canadian doctor’s office falls business directions with their goals. mostly on the physician, while the benefit 2. Booz Allen Hamilton. A 10-year Cost Infoway’s emphasis on interoperability goes to the health care system as a whole; and Benefits Analysis for Deploying a Pan- and vendor-neutral architecture and this is especially true for the many single Canadian Electronic Health Record. standards generates interest from many handed practices and small clinics that do Commissioned by Canada Health Infoway. potential IT partners, and has allowed not have the IT expertise to help them March 2005. Canada’s health care jurisdictions to implement and maintain technology. A 3. Canada Health Infoway. The Evolution reduce costs and obtain upfront financing June 2007 survey identified lack of of Health Care: Making a Difference. from vendors and suppliers. willpower and cost as the two reasons that Canada Health Infoway Annual Report account for approximately 80% of the To protect future investments, Infoway 2007–2008. Montreal: Canada Health barriers to EMR adoption in the province and the jurisdictions have implemented a Infoway, 2008. Available at of Ontario. collaborative risk assessment approach http://www.infoway-inforoute.ca/Admin/ where project and jurisdiction risks are Upload/Dev/Document/Infoway_Annual_ A further complication has been the Report_2007-2008_Eng.pdf clearly identified for risk mitigation and provincial governments’ inconsistent and reporting purposes. In addition, a Quality 4. Schoen C, Osborn R, Huynh P T, Doty differential approaches to EMR funding Assurance Framework was developed and M, Peugh J, Zapert K. On the front lines of which has de facto created two tier primary will be applied to all Infoway investment care: primary care doctors’ office systems, care systems. Physicians who agree to projects. experiences, and views in seven countries. work under particular funding formulas Health Affairs 2006;25(6):w555–w571. have their EMR costs covered by the In closing, a 2007 Conference Board of 5. Flegel K. Getting to the electronic province, whereas those doctors attached Canada study estimated that electronic medical record. Canadian Medical to other funding schemes must draw from health record spending will have created Association Journal 2008;178(5):531. their own resources in order to have EMR 37,000 new jobs by 2010, translating to $2 Available at http://www.cmaj.ca/cgi/ in their practice. billion in new labour income for Cana- content/full/178/5/531 dians.6 And every dollar invested by Another common problem in most Infoway and the provinces adds $1.34 (on 6. Prada G, Santaguidar P. Exploring provinces is ‘data stewardship’, i.e., who Technological Innovation in Health average) to Canada’s gross domestic shall keep the records and who shall own Systems. Ottawa: Conference Board of product. More investment, exports and them. Ownership brings with it an expec- Canada, 2007. Available at employment bring more tax revenues for tation of granting privileges to others to http://sso.conferenceboard.ca/e-Library/ federal and provincial governments – contribute to or gain access to the infor- LayoutAbstract.asp?DID=2098 about $0.36 for each dollar invested. In mation. Concern about privacy and access (by both physicians and patients) seem to NEW PUBLICATION be among the major reasons why Canada has not adopted electronic records to the Caring for People with Chronic Conditions same extent as many other countries have. Nevertheless, the Canadian Medical Asso- Edited by Ellen Nolte and Taking a whole systems ciation believes that the benefits of elec- Martin McKee approach, the book: tronic records clearly outweigh the risks. Open University Press, • Analyses the prerequisites As Flegel so aptly put it, “it has become December 2008, 265 pages for effective policies for clinically counterproductive to allow the chronic care risks to continue to delay the necessary This new book systematically development and implementation of tech- • Examines systems for financing chronic care examines some of the key nologies. If we can handle the myriad issues involved in the care of • Describes the burden of chronic disease in Europe privacy concerns involved in electronic those with chronic diseases. banking, what is holding up electronic • Explores the economic case for investing in medical records? We have the e-tech- Taking an international chronic disease management nology; all we need is the e-will.”5 perspective, it synthesises • Examines key challenges posed by the growing the evidence on what we complexity in health care including prevention, Conclusion know works (or does not) in the role of self-management, the health care As strategic investor, Infoway has success- different circumstances. workforce, and decision support fully worked collaboratively with jurisdic-

Eurohealth Vol 14 No 3 32 EUROPEAN SNAPSHOTS Assessment for reimbursement: Collaboration at EU-level, the MEDEV-experiment

Ad Schuurman

Background oration among participating countries Timing is of the utmost importance when The regulation of medicines in Europe is on the evaluation of clinical research sharing information, as reimbursement largely determined by EU legislation. As a and the cost-effectiveness of medicines decisions need to be made in relatively consequence, close collaboration has been as criteria for reimbursement purposes. short time frames. Several countries may forged over recent decades between the be working simultaneously on the – Promote possibilities for further collab- medicine regulatory authorities in Member assessment of new medicines, so during oration on the exchange of information States, the European Commission and the that short period they should know which on drug prices and concrete steps for European Medicines Agency (EMEA). of their counterparts is/are working on the making price information available on same dossier. On the other hand, other There has also been a growing interest in websites. countries may find themselves in the enhancing the degree to which the second wave of launch, so that they would competent health authorities exchange Activities benefit from knowing in which countries information and share experience on a An expert working group has been formed assessment has already taken place. broad range of pharmaceutical policy on clinical- and cost-effectiveness evalua- matters. tions. It is a collaboration of the national The key functions of MEDEV are set out competent pharmaceutical authorities that in Box 1. MEDEV reviews existing guide- This was a reason why ten years ago, are responsible for assessing (new) lines for assessing medicines for reim- European national competent authorities medicines for reimbursement and/or for bursement and explores possibilities for set up the Medical Evaluation Committee definitions, pricing and reimbursement harmonising these guidelines, at least in the (MEDEV). The experiences of MEDEV to conditions. It meets on a regular basis (six area of clinical effectiveness. The group date are discussed in this snapshot article. times a year) to discuss the evaluation of also discusses criteria for the re-assessment MEDEV is an expert group that meets on new medicines being considered for of medicines for reimbursement in the an informal basis and explores the reimbursement. light of new information on clinical potential for collaboration in the field of effectiveness and indications, shares Information on national reimbursement pharmaceutical policies and, in particular, information on reviews of national decisions is shared between direct contacts with respect to the evaluation of medi- reimbursement decisions and discusses and via the password-protected website. cines. It should be clear however that final decisions and possible negotiations (regarding price, certain restrictions on indications, who can prescribe) remain the Box 1: Principal elements of assessment responsibility of each national competent authority. 1. Monitoring (new) drug assessments in all seventeen participating countries and exchanging Objectives information on current assessments. MEDEV collaborates on exchanging 2. Exploring and developing the methodology and criteria for assessing drugs for reimbursement. information and sharing experiences among European countries on pharmaceu- 3. Reviewing existing guidelines for assessing medicines for reimbursement and exploring tical policies. The key objectives are to: possibilities for harmonising guidelines, starting in the field of clinical effectiveness. – Enhance possibilities for further collab- 4. Discussing criteria for the re-assessment of medicines for reimbursement in the light of new information on clinical effectiveness and indications, and sharing information on the review of national reimbursement decisions. Ad Schuurman is President of MEDEV and Head of the Reimbursement 5. Discussing criteria for therapeutic equivalence and inter-changeability. Department at the Dutch Health Care 6. Collaborating on post-listing reviews (for example, Vioxx, Celebrex) and adjusting indications. Insurance Board, Amsterdam, The Netherlands. 7. Discussing arrangements for reference pricing and (therapeutic) clustering. Email: [email protected]

33 Eurohealth Vol 14 No 3 EUROPEAN SNAPSHOTS criteria for therapeutic equivalence and inter-changeability. Confidentiality of Moldova: information is a pertinent concern. At the moment MEDEV is preparing two pilot studies and will start providing Using social health insurance to general, informal advice to two small companies producing new orphan drugs. reduce out-of-pocket payments This will include scientific advice, as well as information on procedures and adequate assessment dossiers. If possible, and improve equity MEDEV will do an (informal) assessment. Small pharmaceutical companies in particular have problems submitting their new drugs to the twenty-seven different reimbursement authorities in the EU. This Erica Richardson model could also prove relevant for larger firms. All of the above represents a pragmatic, informal way for MEDEV to develop a Social health insurance (SHI) schemes have the successes of the Moldovan experience perspective on general, adequate assess- been introduced in many countries of the are elaborated and areas where further ments. To date MEDEV has succeeded in former Soviet Union as a means of developments are needed are highlighted. performing thirty such assessments; opening up the health sector to non-state national authorities can then at their actors and opening up another stream of Out-of-pocket payments discretion make use of these assessments funding for health systems which had been According to World Health Organization in accordance with the subsidiarity dealing with decades of underfunding and (WHO) data, OOPs as a proportion of principle. falling budgetary allocations. However, total health expenditure in Moldova the introduction of SHI in countries of the peaked in 2000 at 50.5%.3 Such high Conclusion former Soviet Union has not generally OOPs were a significant barrier to services The MEDEV experiment demonstrates been successful in increasing revenues for for the poorest households and an indi- that it is possible to cooperate successfully health funding, or improving transparency, cator of serious inequities.4 Formal user on the assessment on medicines for access to services, or overall equity in the charges had been introduced in 1999 in reimbursement at an EU-level. The results system.1 Historically, the introduction of order to tackle chronic underfunding in of the informal assessments can be used in SHI as a complementary source of funding the system and to aid transparency. Prior decision making at the level of Member for the health system has not had a to this informal payments for services had States in accordance with the subsidiarity profound impact on the high levels of out become widespread and it was hoped that principle. of pocket payments (OOPs) experienced by ‘formalising’ these payments, issues in some countries of the former Soviet such as differential pricing according to Critical is the fact that participants are not Union, and financial protection in these staff estimates of how much a specific forced to work together, but rather it is countries remains weak.1 patient could afford, could be addressed.5 effective because it facilitates collegial However, formalising payments did little cooperation between individuals working Nevertheless, in order to ensure to reduce the overall cost to patients and it on the same job: the scientific assessment sustainable financing for the health system did not address the inequity of the system and pricing of medicines. In such a way we and as an equitable means of ensuring or provide a financial risk pooling can learn from each other, exchange infor- broad access to health services for the mechanism to protect households from mation, methods and develop a common population, the Government of Moldova catastrophic health costs.2 framework. Potentially the benefits of introduced a SHI scheme on 1 January these activities may also accrue to other 2004.2 The more recent introduction of Formal co-payments were included as a stakeholders including both the pharma- SHI in Moldova would appear to have part of the SHI package for certain ceutical industry and patients. avoided some pitfalls, and evidence is now services, and OOPs as a share of total indicating that the introduction of SHI has health expenditure did fall from 45.8% in been successful in increasing funding for 2003 to 41.4% following the introduction the health system, providing financial risk of SHI in 2004, although creeping up to pooling, as well as reducing OOPs for 42.9% in 2005. However, the structure of poorer households and, thereby, improving out-of-pocket payments has changed access to services and equity.2 In this article much more significantly, as costs for the uninsured are significantly higher than for the insured. On average in 2005, for Erica Richardson is Research Officer, example, the cost of hospitalisation for European Observatory on Health Systems insured patients was 83% lower than for and Policies and Research Fellow, London uninsured patients.6 This means that many School of Hygiene and Tropical Medicine. of the poorest households now have better Email: [email protected] protection from catastrophic health costs

Eurohealth Vol 14 No 3 34 EUROPEAN SNAPSHOTS as the non-working population is covered NHIC reduces pressure on service Conclusions by government contributions to the SHI providers to ‘make up’ funding shortfalls The main lesson that could be learnt from scheme. by charging patients informally. It has also the Moldovan experience is that SHI is not meant an increase in both health care a cheap option for governments; in order SHI in Moldova expenditure as a percentage of Gross to reduce OOPs and improve financial SHI was first introduced on paper in 1998, Domestic Product (GDP) and as a share of protection for the population, it is but was not possible to implement at the total health expenditure from public necessary to increase pre-payment for time due to severe fiscal difficulties faced sources. services. If the system is going to function by the Moldovan government. However, adequately, there needs to be equivalence The balance of public and private expen- this break between the introduction of between contributions from the central diture on health has shifted. According to SHI and actual implementation allowed budget for the non-working population WHO estimates, in 2003, 51% of total the government time to learn from the and payroll contributions from the health expenditure came from public problems faced in other countries which working population. sources, but this jumped to 56.8% in 2004, had Semashko systems but had introduced falling to 55.5% in 2005. Overall, total The credibility of the system rests on its SHI. The new system was eventually health expenditure as a proportion of GDP introduced nationwide on 1 January 2004. ability to actually fund the services it has also risen significantly since the purports to cover. Therefore, it is In Moldova, the introduction of SHI introduction of SHI; according to WHO important that allocations from the third- involved the recentralising of health estimates, from 6.8% in 2003 to 7.4% in party payer do indeed cover costs to the financing to the independent non-profit 2004 and 7.5% in 2005.3 Total health service provider, so there is less need to National Health Insurance Company expenditure in terms of purchasing power make up the difference by charging (NHIC) rather than the introduction of parity reached its nadir in 1999 at $71 per patients directly. However, it is also competing funds. This helped to ‘re-inte- capita and, although still low by regional important to review the benefits package grate’ financial pooling. The NHIC standards, it grew to $170 per capita in covered by SHI, in order to ensure that contracts with public and private health 2005.3 important aspects of the health system that service providers, where possible on a are not covered do not act as a barrier to competitive basis, to purchase health Future challenges accessing care and thus threaten equity in services covered under SHI. General Coverage of the rural ‘self-employed’ poor the system. taxation revenues cover a limited number population needs to be improved to allow of basic services as part of a universal the working poor to benefit from SHI. package of benefits. All other services, This is currently the main challenge to REFERENCES including those for the uninsured, are equity in the Moldovan health system, as 1. Preker AS, Jakab M, Schneider M. purchased out of pocket. paying full costs for health care out of Health financing reforms in central and Payroll contributions from the working pocket is a significant barrier to accessing eastern Europe and the former Soviet population were set at 2% of wages for health services not covered by the limited Union. In: Mossialos E, Dixon A, Figueras both employees and employers. Although universal package. Estimates of coverage J, Kutzin J (eds). Funding Health Care: a 2% reduction in income tax helped to levels also need to be more sensitive to Options for Europe. Buckingham: Open offset the cost for employees, the overall ensure the poorest rural regions are not left University Press, 2002. tax burden in Moldova is high so the with the least funding for services. 2. Atun R, Richardson E, Shiskhin S, benefits of this were not necessarily felt by Currently, in providing funding for Kacevicius G, Ciocani M, Sava V. Health the working population. The self- services, the NHIC assumes that 20% of systems in transition: Moldova. Health employed are responsible for paying their the population are uninsured. However, in Systems in Transition 2008:10(5). 2004, 24.3% of the population were unin- own contributions at a fixed rate. 3. World Health Organization Regional However, there is cause for concern as sured and there were significant regional Office for Europe. European Health for most of those considered self-employed variations – from 58% in the rural Cahul All Database. Copenhagen: World Health 2 are engaged in subsistence farming, most region to 85% in Chisinau municipality. Organization Regional Office for Europe, do not pay their contributions and are More generally, the main out-of-pocket 2008. 2 consequently not covered under SHI. cost to patients is pharmaceuticals, very 4. World Bank. Moldova Health Policy Significantly, government contributions few of which are covered either by the Note: The Health Sector in Transition. paid on behalf of the non-working popu- state-funded universal package or SHI Washington D.C: World Bank, 2003. lation are equivalent to contributions from contributions. Following the introduction 5. Allin S, Davaki K, Mossialos E. Paying the working population and both are of SHI in 2004, spending on pharmaceu- for ‘free’ health care: the conundrum of linked to real costs. This is important as it ticals from private, as opposed to public informal payments in post-communist has ensured that health care funding covers sources, fell to 63.3%, however the Europe. In: Global Corruption Report health care costs. An inadequate proportion has since returned to a higher 2006: Corruption and Health. Berlin: government contribution on behalf of the level, 79.9% in 2005 and 79.5% in 2006.3 Transparency International, 2006. non-working population is one reason Therefore it is necessary to gradually 6. Shishkin S, Kacevicius G, Ciocanu M. why the introduction of SHI has not been increase the number of products covered Evaluation of Health Financing Reform in as successful in providing equitable cover by SHI and reduce the OOP burden for the Republic of Moldova. Copenhagen: and reducing OOPs in other countries.1 pharmaceutical spending; although this WHO Regional Office for Europe, 2006. The more accurate reflection of real costs needs to be achieved without jeopardising in the pricing of services paid for by the current fiscal successes.

35 Eurohealth Vol 14 No 3 Risk in Perspective

OZONE AND MORTALITY – AN UPDATE

Joel Schwartz

While it has long been accepted that ozone can produce morbidity, as clearly demonstrated in chamber studies, the evidence that ozone kills people is rela- tively new, and more controversial. In particular, a number of questions have strong.6 Among the questions raised to the been raised that are central to translating that literature into risk assessment and committee are those in the introduction. benefit analyses. Is the ozone-associated mortality just short-term mortality These address the potential for displacement? Does risk vary by individual? If so, what characteristics define the confounding (i.e., that other exposures at-risk individual? Are the associations confounded by temperature? By other may actually be responsible for the secondary air pollutants? How are any early deaths associated with ozone observed association), as well as questions about who is being affected that have exposure to be valued? Recent work by Harvard Center for Risk Analysis faculty importance for health impact assessments and staff has addressed these questions, and is summarised below. and benefit analyses. Because of the critical role these might play in estimating an Background appropriate level for the standard, we have While many studies have reported adverse been active in addressing these issues. A responses to ozone, a highly oxidising gas, recent Risk in Perspective article (RIP) has reports that ozone exposure might hasten focused on the valuation issue, which of 7 deaths have been more recent. The first course generalises to other exposures. large-scale report came from Europe, This RIP will focus on results addressing where seven cities were studied using iden- the other questions. tical methods and the results combined.1 Studies from Europe during that period Are the ozone-associated deaths due to (the 1990s) have the advantage that use of other exposures? air conditioning was quite low. Open The major concern of observational windows ensure that day-to-day changes epidemiology studies is that some other in outdoor ozone concentrations are more exposure, correlated with the exposure of highly correlated with day-to-day changes interest, may explain the observed associ- in personal exposure, and hence reduce ation, which is not causal but due to that exposure error. This may limit generalis- correlation. To confound studies of short ability to North America, however. Since term changes in ozone and daily deaths, then a number of studies have reported such confounders must co-vary with similar results, including three large meta- ozone over the same timescale. There are analyses commissioned by the United two obvious candidates for such a States Environmental Protection Agency confounder – temperature and other This article is reproduced with permission (EPA).2–4 Moreover, a large multi-city secondary pollutants. and was first published as Risk in study has found no evidence of a threshold Are the ozone-associated deaths due to Perspective Volume 16, Number 2 by the down to very low levels.5 the association of ozone with high Harvard Center for Risk Analysis in July The implications of these findings for temperature? 2008. Peer reviewer: Michelle Bell. ozone risk assessment are enormous. In Ozone is not directly emitted by polluting Harvard Center for Risk Analysis, cost-benefit analyses of air pollutants, sources. It is produced by chemical reac- Harvard School of Public Health, mortality risks, when monetised, dominate tions in the atmosphere between nitrogen Landmark Center, 401 Park Drive, the benefit calculation. Because of this, a oxides and volatile organic compounds PO Box 15677, Boston, National Academy of Sciences committee (VOCs), and those reactions are driven by Massachusetts, 02215 USA. was commissioned to review the evidence. sunlight and temperature. Hence ozone The full series is available at Its report, recently issued, concluded that co-varies with temperature. All studies of www.hcra.harvard.edu the evidence for a mortality association is the effect of ozone on daily deaths have

Eurohealth Vol 14 No 3 36 EVIDENCE-INFORMED DECISION MAKING therefore controlled for temperature. and hydrocarbons, also reduce these other run. This could, for example, include However, the association of temperature secondary pollutants, such as PAN, it may people with severe pneumonia, or with with death is highly non-linear, with heat not be critical for policy analysis to distin- acute inflammations that have decreased wave conditions associated with much guish among them. However, all strategies the stability of atherosclerotic plaques that larger increases in deaths than tempera- do not reduce these secondary pollutants are temporarily at much higher than tures just a few degrees cooler. How can equally, and secondary sulphate particles normal risk of rupturing and producing a we be sure that those studies correctly would be reduced by a completely heart attack. Individuals in this high-risk captured that relation, and that the ozone different strategy, the control of sulphur pool can recover and return to a more association is not due to ozone capturing oxide emissions. Hence this is a key normal risk, or they can die. Each day the remaining effect of temperature? remaining uncertainty. some die, some recover, and some new people enter the high-risk pool. Concep- I addressed this in an analysis of over one To address this, Franklin and Schwartz tually, air pollution might affect all three million deaths in fourteen cities.7 Rather turned to the EPA’s speciation* moni- transition rates. If air pollution only than examine the correlation between daily toring network.8 Unfortunately, this increased the rate of dying out of the pool, ozone and daily deaths, I converted the network which has only been operating then we would expect the pool to be analysis into a case-control study. Using a since 2000, usually monitors only one in depleted by an ozone episode, resulting in variant called case-crossover analysis, I three or one in six days, and only measures fewer deaths in the next week. In this case, matched each decedent with him or particles and not other oxidant gases. the deaths associated with ozone exposure herself, on a control day in the same month Nevertheless, using data from eighteen are only being brought forward by a short of the same year that they died, which also cities with speciated particle measure- period. However, if ozone affects the had the same temperature (rounded to the ments, we showed that control for nitrate recruitment rate, the size of the pool could same degree). This matching controlled for particles or organic carbon particles did actually increase, and excess deaths could season and time trend, by choosing a not change the estimated effect of ozone continue well after the ozone episode control day in the same month and year as on mortality. In contrast, control for occurred. the date of death, and since the temper- sulphate particles reduced the estimated ature was the same on the control day as ozone effect by about 25%, although the If ozone’s primary effect is on the death the case day, it could not explain which day confidence interval in that estimate was rate from the risk pool and deaths were the death occurred on. I then compared the wide, and included the possibility of no only being brought forward by, for ozone levels on the two days to see if they change in the ozone effect. Hence some of example, seven days, then, ceteris paribus, predicted which day was the date of death. the effect attributed by past studies to we would expect a negative correlation I found the same association with ozone ozone may have been due to sulphate between ozone exposure today and deaths that I found analysing the data using the particles, but organic and nitrate particles a week from now. Zanobetti and Schwartz more traditional time series analysis. This do not appear to be confounders. used this insight to look at the correlation indicates that confounding by temperature between ozone levels and death counts in is unlikely to explain the observed ozone Are the ozone-associated deaths forty-eight US cities for time periods up to mortality association. advanced by only a small amount? twenty-one days after exposure.9 One possible explanation of the observed Are the ozone-associated deaths due to They found that there was no negative associations is that they are causal, but that other secondary pollutants? correlation between ozone and mortality only extremely sensitive individuals, who up to twenty-one days later, and that the The same processes, chemical reactions are on the brink of death, are affected by positive association persisted over several driven by light and heat, that produce this exposure. If ozone is merely bringing days but fell to zero within a few days. The ozone also produce other secondary pollu- forward deaths among people who would overall effect of ozone over the period was tants (secondary because they are not have died in the next week anyway, the an increase of 0.5% in daily deaths directly emitted). Among these are public health impact of the observed ozone (95%C.I.: 0.05–0.96) per 10 parts per sulphate particles, from the reaction of mortality association is much reduced. billion (ppb) increase in eight hour average sulphur oxides with ammonia, nitrate Recently, we addressed this question in a ozone, compared with an increase of 0.3% particles, from the reaction of nitrogen large, multi-city study. (95%C.I.: 0.2–0.4) when deaths on only oxides with ammonia, and organic To understand this question, it is useful to one day were considered. Hence the deaths particles, which like ozone derive from consider the schematic below. In it, we associated with ozone are not just being reactions of hydrocarbons. In addition, imagine that there is a pool of persons who brought forward by a few weeks, and other gaseous pollutants, such as peroxy- are highly susceptible to dying in the short previous studies may have underestimated acetylnitrate (PAN), are produced by the same type of reactions that produce ozone. These pollutants are rarely measured, and hence previous studies have not controlled for them. To the extent that the control measures adopted to reduce ozone, such as T1 reductions in emissions of nitrogen oxides General Risk T3 Death population pool * Speciation analysis is the identification and/or measurement of the quantities of T2 one or more individual chemical ‘species’ in a sample.

37 Eurohealth Vol 14 No 3 EVIDENCE-INFORMED DECISION MAKING the overall effect of ozone on mortality by Analyses of mortality data are limited to Epidemiology 2005;16(4):458–68. just considering the effect of the ozone on looking at modifying factors that are 4. Ito K, De Leon SF, Lippmann M. deaths the same day. shown on the death certificate. Exami- Associations between ozone and daily nation of other potential markers of mortality: analysis and meta-analysis. Who is susceptible to the effects of susceptibility requires other techniques. Epidemiology 2005;16(4):446–57. ozone? One approach is to look at a surrogate 5. Bell ML, Peng RD, Dominici F. The The question of who is dying on high- outcome. Lung function is a continuous exposure-response curve for ozone and ozone days affects many areas of risk outcome which is highly predictive of risk of mortality and the adequacy of assessment and health policy analysis. The mortality rate. We examined the short term current ozone regulations. Environ presence of chronic conditions or the age association between ozone and decrements Health Perspect 2006;114(4):532–36. of the individuals at risk may affect the in lung function (forced expiratory volume 6. National Research Council. Estimating benefit values associated with delaying the in 1 second, FEV1) in a cohort of elderly Mortality Risk Reduction and Economic men in the Boston area. We found that ozone-associated deaths. In addition, since Benefits from Controlling Ozone Air the age pyramid and prevalence of certain ozone was associated with reduced FEV1, Pollution. Washington, DC: National conditions are changing in the United but that the effect was larger in obese Academies Press, 2008. States and elsewhere, understanding of the subjects.15 Since obesity is a growing 7. Hammitt J. Valuing “lives saved” vs. relative risks in different subpopulations problem all over the world, this suggests “life-years saved.” Risk in Perspective will be important. To address this, we that in the absence of contravening changes 2008;16 (1):1–5. conducted a case-only study. A case-only in other risk modifiers, the susceptible study is focused on identifying factors that pool may grow over time. 8. Schwartz J. How sensitive is the modify risk, and does not examine what association between ozone and daily the baseline risk is. It is based on the Conclusions deaths to control for temperature? Am J Respir Crit Care Med 2005;171(6):627–31. following idea. Suppose some personal While uncertainties still remain, a signif- characteristic, for example diabetes, icant fraction of the questions have been 9. Franklin M, Schwartz J. The impact of modifies the risk of dying on a high air resolved. The ozone-associated deaths do secondary particles on the association pollution day. Then one would expect, on not appear to be short-term mortality between ambient ozone and mortality. average, more of the deaths on high-ozone displacement and aggregate effects over Environ Health Perspect 2008; days to be among diabetics than the deaths several days may increase the risk esti- 116(4):453–58. on low-ozone days. Therefore, one can test mates. There may be some confounding by 10. Zanobetti A, Schwartz J. Mortality this hypothesis (greater susceptibility of sulphate particles, but not by other displacement in the association of ozone diabetics to ozone) by doing a regression secondary particles. This may reduce the with mortality: an analysis of 48 cities in on the people who died over a period of risk estimates. Most of the ozone- the United States. Am J Respir Crit Care years, with the outcome whether or not associated deaths are in the elderly, but the Med 2008;177(2):184–89. they were diabetic, and the predictor the differences by race and sex may be 11. Schwartz J. Who is sensitive to ozone concentrations on the day they died. important. Major chronic diseases such as extremes of temperature? A case-only This approach has the advantage that chronic obstructive pulmonary disease analysis. Epidemiology 2005;16(1):67–72. things that only predict whether or not a (COPD) and diabetes that provide signif- 12. Armstrong B. Fixed factors that person died are not confounders in this icant reductions in quality of life are not modify the effects of time-varying factors: analysis, since they don’t predict the modifiers of the ozone-association. applying the case-only approach. outcome (diabetes, not deaths).10,11 However, while diabetes is not a modifier, Epidemiology 2003;14(4):467–72. obesity may be. Given trends in obesity Our analysis examined 2.7 million deaths 13. Medina-Ramon M, Schwartz J. Who over time, this will also be relevant for risk in forty-eight cities between 1989 and is more vulnerable to die from ozone air assessments. 2000.12 We found, as expected, increased pollution? Epidemiology 2008; susceptibility among people aged sixty-five 19(5):672–79. and older (~2.7 fold higher percentage 14. Medina-Ramon M, Zanobetti A, REFERENCES increase in deaths per 10 ppb of ozone). Cavanagh DP, Schwartz J. Extreme More interestingly, the black population 1. Touloumi G, Katsouyanni K, Zmirou temperatures and mortality: assessing had roughly 1.8 times the percentage D, et al. Short-term effects of ambient effect modification by personal character- increase in deaths as the non-black popu- oxidant exposure on mortality: a istics and specific cause of death in a lation, and women over the age of sixty combined analysis within the APHEA multi-city case-only analysis. Environ had about 1.9 times the percentage in project. Air pollution and health: a Health Perspect 2006;114(9):1331–36. European approach. Am J Epidemiol crease in death as men. Below age sixty, 15. Zeka A, Zanobetti A, Schwartz J. 1997;146(2):177–85. however, there was no difference between Individual-level modifiers of the effects of the risk in men and women, suggesting 2. Bell ML, Dominici F, Samet JM. A particulate matter on daily mortality. Am some protection by hormonal status. meta-analysis of time-series studies of J Epidemiol 2006;163(9):849–59. ozone and mortality with comparison to Among chronic diseases, atrial fibrillation 16. Alexeeff SE, Litonjua AA, Suh H, the national morbidity, mortality, and air was associated with 1.7 times the Sparrow D, Vokonas PS, Schwartz J. pollution study. Epidemiology percentage increase in deaths per 10ppb of Ozone exposure and lung function: effect 2005;16(4):436–45. ozone. Previous studies have suggested modified by obesity and airways hyper- that atrial fibrillation also increased the risk 3. Levy JI, Chemerynski SM, Sarnat JA. responsiveness in the VA normative aging of dying on very hot days,13 or as a result Ozone exposure and mortality: an study. Chest 2007;132(6):1890–97. of particle exposure.14 empiric bayesian metaregression analysis.

Eurohealth Vol 14 No 3 38 Evidence-based health care

Pharmacy care in older patients

We know that many people do not take needing to be solved. A trial from the USA1 medicines prescribed for them, and that suggests that extremely good adherence adherence rates are often low. We also know results can be had from some simple inter- that older people have problems with their ventions from pharmacists that help older medicines, often because they are prescribed people understand and manage their medi- many medicines, to be taken at different cines. times of the day. Finally, we know that major influences on admission to hospital Trial with adverse drug reactions include older This is an interesting example of a age, being a woman and having lots of randomised withdrawal trial design outlined tablets to take. in Figure 1. It does not need a brain the size of the planet 1. All patients entered a two month run-in to see that there are some problems here period used to ascertain baseline adherence and measure blood pressure and cholesterol. Figure 1: Randomised withdrawal design of study of pharmacy care in older patients with multiple health problems 2. After this, all patients entered an inter- vention phase, during which they received their drugs individualised in blister packs with tablets labelled for time Usual care (6 months) of day. This was supplemented with indi- vidualised education visits, and follow up with a pharmacist every two months. Run in (2 months) Intervention (6 months) These visits taught patients about their drugs, their names and indication, strengths, adverse events and usage Continued intervention RANDOMISATION instructions. (6 months) 3. After six months, patients were randomised to continuing the inter- vention or usual care. Table 1: Median adherence (% of all tablets taken) and percentage of patients taking at least 80% of all medicines Adherence, blood pressure, and cholesterol were measured during the run-in period and Randomised to at the end of each six-month period. Run-in Intervention Usual care Intervention Results Initially, 200 patients entered the run-in period and 159 were eventually randomised. Month 2 8 14 14 Their average age was 78 years (minimum 65 years), 77% were men, 57% had four or Median adherence (%) 62 99 68 96 more health problems, with an average of nine chronic medications. There were high >80% adherence to all levels of use of statins and blood pressure 5 99 22 97 medicines medicines. Results for adherence are shown in Table 1. The pharmacy care programme resulted in Bandolier is an online journal about evidence-based healthcare, written by Oxford a large increase in adherence, with the scientists. Articles can be accessed at www.jr2.ox.ac.uk/bandolier proportion of patients more than 80% This paper was first published in 2007. © Bandolier, 2007. adherent to all medicines increasing from

39 Eurohealth Vol 14 No 3 EVIDENCE-INFORMED DECISION MAKING just 5% in the run-in period to 99%. After randomisation, the intervention group New series of policy briefs launched at maintained these high levels of adherence, while return to usual care resulted in a WHO European Ministerial Conference large decrease in adherence, approaching rates seen in the run-in period. ‘Health Systems, Health and Wealth’ Increased adherence resulted in large reductions in systolic and diastolic blood A new series of policy briefs on health systems and health pressure during the intervention period; policy issues was launched at the WHO European Ministerial for LDL (low density lipoprotein) choles- Conference on Health System held in Tallinn, Estonia in June terol useful reductions in both groups 2008. A joint project between the Health Evidence Network were maintained after randomisation, with and the European Observatory on Health Systems and no significant difference between them. Policies, this new series aims to meet policy-makers’ requirements in two ways. First, it presents a rigorous Comment review of the available research evidence, and second, the This is a very important study, which briefs are written in a language accessible to non-specialist shows that to achieve high adherence in policy-makers and follow a consistent format. older people with multiple health Appropriateness and implementation are key considerations problems and medications continuing for the series. Countries have different requirements and intervention is needed. The paper, and demands and a given policy option is unlikely to be relevant especially the thoughtful discussion, or appropriate to all systems and approaches. As such, the should be read by anyone wanting to do briefs do not aim to provide an ideal ‘model’ or recom- better. mended approach. Instead, they cover and synthesise The benefits of high adherence are poten- available research evidence and potential policy options for tially large, given the generally low best practice, such that policy makers can consider means adherence usually seen in these circum- and strategies towards innovating in their respective stances, and given that low adherence is systems. associated with increased rates of hospital The briefs bring together key evidence underlining the admission. This is not a simple answer to a central themes of the Conference: health and wealth, public simple problem, but an indication that health, governance, coordinated care, human resources, and with insightful pragmatic action much financing. Given the focus of the Conference, the underlying better outcomes can result. concern of all the briefs was to improve health system After all, the pills are better in the patient performance. than in a bottle. If the latter we pay twice, Nine joint policy briefs have been published: in unused medicine and more health care costs. Given the acknowledged size of the
How can European health systems support investment in problem, the implication is that this is a and the implementation of population health strategies? topic area that requires some sensible
How can the impact of health technology assessments be research and action. enhanced?

Where are the patients in decision making about their own care? REFERENCE 1. Lee JK, Grace KA, Taylor AJ. Effect of
How can the settings used to provide care to older a pharmacy care program on medication people be balanced? adherence and persistence, blood pressure, When do vertical (stand-alone) programmes have a place and low-density lipoprotein cholesterol. A
in health systems? randomized controlled trial. Journal of the American Medical Association 2006 296:
How can chronic disease management programmes 2563–71. operate across care settings and providers?

How can the migration of health service professionals be managed so as to reduce any negative effects on supply?

How can optimal skill mix be effectively implemented and why?

Do lifelong learning and revalidation ensure that physicians are fit to practice? The briefs are available in English, French, German and Russian at http://www.euro.who.int/HEN/policybriefs/20080814_2

Eurohealth Vol 14 No 3 40 NEW PUBLICATIONS

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

Health for all? A critical analysis of This study compares the evolution of strategies focusing on specific health deter- public health policies in eight national public health policies in eight minants; disease-specific strategies; group- European countries European countries with attention to their specific strategies; arena approaches; character and contents concerning social implementation methods, resources and and lifestyle determinants; the involvement main actors; as well as monitoring and eval- Edited by Christer Hogstedt, Henrik of non-health sectors (for example, uation. Also considered are behavioural risk Moberg, Bernt Lundgren and Mona education, labour market, environment); factors and measures taken to tackle Backhans and experiences with different strategies. A lifestyle factors, such as tobacco, alcohol detailed literature review is also presented and overweight. on comparative studies of policies on health The ultimate objective of this study was to inequalities. identify common experiences, notable For each country, the public health situ- differences and lessons. One of the main ation is examined by a local expert making findings of the publication is that “the way use of a comprehensive template. Findings health inequalities are explained is closely include: development of society and the related to the way they are dealt with, i.e. present policy environment; magnitude, to what extent governments try to make trends and analysis regarding social people behave differently or attempt to inequalities in health; public health change their living conditions.” ISBN 978-91-7257-572-1 Contents: 358 pages Foreword; Contributors; Comparative Studies of Policies on Health Inequalities – Freely available online at: A Literature Review; Health Inequities – Concepts, Measures and Pathways; http://www.fhi.se/shop/material_pdf/ Denmark; England; Finland; Italy; The Netherlands; Norway; Spain; Sweden; R200821_Health_for_all0808komp.pdf Summary Chapter; Concluding Remarks and Recommendations.

Closing the gap in a generation: Many of the differences in health between the state of Kerala in India and Sri Lanka Health equity through action on the and within countries result from the social have achieved levels of good health despite social determinants of health environment where people are born, live, relatively low national incomes. grow, work and age. These so-called ‘social The Chair of the Commission, Sir Michael determinants of health’ have been the focus Marmot, commented that an “effective way Commission on Social Determinants of of a WHO Commission established in of increasing life expectancy and improving Health 2005, which aimed to marshal evidence and health would be for every government make recommendations on reducing health policy and programme to be assessed for its inequities. Their final report was published impact on health and health equity”. The in August 2008. report cites the Nordic countries as The report goes beyond measuring health providing outstanding policies that have inequities between countries, and docu- encouraged equality of benefits and ments ‘health gradients’ within countries as services, full employment, gender equity well, for example, by showing differences and low levels of social exclusion, that in life expectancy and maternal mortality should be adopted everywhere. for different cultural groups within the The full report in English and the executive same country. On the topic of health and summary in six UN languages, along with Geneva: World Health Organization, wealth, the report shows that wealth alone supporting press release, country examples, 2008 does not have to determine the health of a figures, tables and graphs and podcast are nation’s population. Some low-income ISBN 978 92 4 156370 3 available for download. countries such as Cuba, Costa Rica, China, 247 pages Freely available at: Contents: http://www.who.int/social_ Executive Summary; Setting the Scene for a Global Approach to Health Quality; determinants/final_report/en/index.html Evidence, Action, Actors; Daily Living Conditions; Power, Money and Resources; Knowledge, Monitoring and Skills; Building a Global Movement; List of Recommendations.

41 Eurohealth Vol 14 No 3 Please contact Philipa Mladovsky at [email protected] to suggest web sites WEBwatch for potential inclusion in future issues.

Northern Dimension The NDPHS brings together thirteen governments, the European Commission and eight interna- Partnership in Public Health tional organisations, to focus on northern Europe. The English, Polish and Russian language web site and Social Well-being provides information about events, an e-newsletter, and presentations. It also provides access to the (NDPHS) work of expert groups on HIV/AIDS, prison health, primary health care, social inclusion, healthy lifestyles and work ability. An online database contains information on projects, papers and contacts. http://www.ndphs.org It also contains a ‘project pipeline’, a multi-agency on-line project funding coordination tool.

Baltic Sea Network on The BSN brings together occupational health and safety institutions from all the countries Occupational Health and bordering the Baltic Sea, ranging from Norway to Russia. The site contains a modest amount of Safety (BSN) information including the annual workplan, meeting reports, contact information for participants, links to other occupational health and safety organisations, as well as access to relevant reports http://www.balticseaosh.net stored in the NDPHS database.

Eurosafe The English-language web site of the European Association for Injury Prevention and Safety Promotion (Eurosafe) contains information on various activities including the consumer safety http://www.ecosa.org programme, EU Injury database and European Child Safety Alliance. It also contains the archives of Eurosafe Alert, the organisation’s regular newsletter, including a special edition on the recent 2nd European Conference on Injury Prevention held in Paris in October 2008. A ‘knowledge base’ section is a plethora of information on topics such as measurement and risk assessment.

DETERMINE DETERMINE is an EU consortium for action on socioeconomic determinants of health. It hosts an English-language European Portal for Action on Health Equity. This contains: country health http://www.health- inequality profiles; a database of good practices; an EU Policy Section with case studies; a health in inequalities.eu all policies section with examples of how other policy areas can contribute to greater health equity; relevant links to other health inequalities related resources on the web; events information; and publications.

European Monitoring EMCDDA is one of the European Union’s decentralised agencies. Established in 1993 and based in Centre for Drugs and Lisbon, it is the central source of comprehensive information on drugs and drug addiction in Drug Addiction Europe. Most of the web site’s content is in English but some pages are available in twenty-four (EMCDDA) European languages. It provides drug related statistics, as well as country profiles, information on EU law on drugs, news and publications. Evidence for policy is available in a ‘best practice portal’. http://www.emcdda.europa.eu

Foresight Project on Mental The aim of the Foresight Project on Mental Capital and Wellbeing has been to advise the UK Capital and Wellbeing government on how to achieve the best possible mental development and mental wellbeing for everyone in the future. The Project has collated high quality scientific evidence and involved the http://www.foresight.gov.uk/ collaboration of a large number of expert advisors. The recently launched final report, as well as a OurWork/ActiveProjects/ large number of background documents, CD ROMs, and an article published in Nature, can be Mental%20Capital/Welcome.asp freely accessed at the English language web site. Topics include analysis of future challenges for mental health, as well as the complex relationship between wellbeing and work.

Eurohealth Vol 14 No 3 42 MONITOR

EUROPEAN MONITOR Commission Chair, Sir Michael determine the health of a nation’s Marmot, said that “central to the population. Some low-income Commission’s recommendations countries such as Cuba, Costa WHO Commission: Inequities is creating the conditions for Rica, China, the state of Kerala in killing people on a “grand people to be empowered, to have India and Sri Lanka have scale” freedom to lead flourishing lives. achieved levels of good health The final report of the WHO Nowhere is lack of empow- despite relatively low national Commission on the Social Deter- erment more obvious than in the incomes. But, the Commission minants of Health Closing the plight of women in many parts of points out, wealth can be wisely Gap in a Generation: Health the world. Health suffers as a used. Nordic countries, for Equity through Action on the result. Following our recommen- example, have followed policies Social Determinants of Health dations would dramatically that encouraged equality of was published on 28 August in improve the health and life benefits and services, full Geneva. The report is the result chances of billions of people.” employment, gender equity and low levels of social exclusion. of a three-year investigation by The Commission found evidence This, said the Commission, is an an eminent group of policy that demonstrates, in general, outstanding example of what makers, academics, former heads that the poor are worse off than needs to be done everywhere. of state and former ministers of those less deprived. They also health. found that the less deprived are in Solutions from beyond the Stark findings include the obser- turn worse than those with health sector average incomes, and so on. This vation that children born in a Much of the work to redress slope linking income and health Glasgow suburb can expect a life health inequities lies beyond the is the social gradient, and is seen twenty-eight years shorter than health sector. According to the everywhere – not just in devel- those living only thirteen kilo- Commission’s report, “Water- oping countries, but in all coun- metres away, while a girl in borne diseases are not caused by tries, including the richest. The Lesotho is likely to live forty- a lack of antibiotics but by dirty slope may be more or less steep two years less than another in water, and by the political, social, in different countries, but the Japan. In Sweden, the risk of a and economic forces that fail to phenomenon is universal. woman dying during pregnancy make clean water available to all; and childbirth is one in 17,400; in Wealth is not necessarily a heart disease is caused not by a Afghanistan, the odds are one in determinant lack of coronary care units but by eight. Biology does not explain lives people lead, which are Economic growth is raising any of this. Instead, the differ- shaped by the environments in incomes in many countries but ences between – and within – which they live; obesity is not increasing national wealth alone countries result from the social caused by moral failure on the does not necessarily increase

News environment where people are part of individuals but by the national health. Without equi- born, live, grow, work and age. excess availability of high-fat and table distribution of benefits, “(The) toxic combination of bad high-sugar foods.” The health national growth can even exac- policies, economics, and politics sector – globally and nationally – erbate inequities. is, in large measure responsible needs to focus attention on for the fact that a majority of While there has been an addressing the root causes of people in the world do not enjoy enormous increase in global inequities in health. the good health that is biologi- wealth, technology and living “We rely too much on medical cally possible…Social injustice is standards in recent years, the key interventions as a way of killing people on a grand scale.” question is how it is used for fair increasing life expectancy” distribution of services and insti- “Health inequity really is a explained Sir Michael. “A more tution-building, especially in matter of life and death,” said effective way of increasing life low-income countries. In 1980, WHO Director-General Dr expectancy and improving health the richest countries with 10% of Margaret Chan while welcoming would be for every government the world’s population had a the report and congratulating the policy and programme to be gross national income sixty times Commission. “But health assessed for its impact on health that of the poorest countries with systems will not naturally grav- and health equity; to make health 10% of the population. After itate towards equity. Unprece- and health equity a marker for twenty-five years of globali- Press releases and dented leadership is needed that government performance.” sation, this difference has other suggested compels all actors, including increased to 122.. Worse, in the Recommendations information for those beyond the health sector, to last fifteen years, the poorest future inclusion examine their impact on health. Based on this compelling quintile in many low-income can be e-mailed to Primary health care, which evidence, the Commission makes countries have shown a declining the editor integrates health in all of three overarching recommenda- share in national consumption. David McDaid government’s policies, is the best tions to tackle the “corrosive [email protected] framework for doing so.” Wealth alone does not have to effects of inequality of life

43 Eurohealth Vol 14 No 3 MONITOR chances”. First, to improve daily living million will receive no medical assistance Commission acts on excessive working conditions, including the circumstances in whatsoever during childbirth and the time in Greece which people are born, grow, live, work postpartum period, endangering their On 16 October 2008, the European and age. Measures recommended include lives and that of their infants. Commission sent a letter of formal notice investment in early childhood services to Greece for failure to comply with EU Globally, annual government expenditure and fairer access to health care services. rules on maximum working time as on health varies from as little as US$ 20 Second, measures to tackle the inequitable regards doctors in public health services. per person to well over US$ 6,000. For 5.6 distribution of power, money and Vladimír Špidla, EU Commissioner for billion people in low- and middle-income resources globally, nationally and locally. Employment and Social Affairs, said that countries, more than half of all health care Finally, they recognise the importance of the “Working Time Directive protects expenditure is through out-of-pocket monitoring the situation and assessing the workers from being forced to work payments. With the costs of health care impact of intervention. excessive hours, which can endanger their rising and systems for financial protection health and could increase risks for others. Acknowledging the challenge of imple- in disarray, personal expenditures on The Commission must act when it is mentation, the Commission noted that, health now push more than 100 million concerned that minimum standards are on the basis of a commitment to make people below the poverty line each year. not being adhered to.” progress on the social determinants of Data in the report are also indicates a situ- health equity, there are now nine country The Directive (2003/88/EC) limits ation in which many health systems have partners, including Sweden and the UK. working time to 48 hours per week on lost their focus on fair access to care, their WHO will make the report available to average. The Commission has received ability to invest resources wisely, and their Member States which will determine how numerous complaints that Greece has capacity to meet the needs and expecta- the health agency is to respond. suspended some of its working time laws tions of people, especially in impover- so doctors in public hospitals can be The report is available at ished and marginalised groups. As the legally required to work excessive hours. http://www.who.int/entity/social_ report notes, conditions of “inequitable The complaints state that specialist determinants/final_report/en/index.html access, impoverishing costs, and erosion doctors are being obliged to work an of trust in health care constitute a threat average of 60–72 hours per week, with World Health Report calls for a return to to social stability.” doctors in training obliged to work an primary health care approach To steer health systems towards better average of 71–93 hours per week. They On 14 October 2008 in Almaty, Kaza- performance, the report calls for a return also suggest that minimum rest periods are khstan, the World Health Report 2008 to primary health care, a holistic approach not being respected, with doctors required Primary Health Care – Now More Than to health care formally launched thirty to work up to 32 continuous hours. The Ever was launched. The launch commem- years ago. When countries at the same Directive stipulates that a worker is orates the 30th anniversary of the Alma- level of economic development are entitled to eleven hours a day of rest and Ata International Conference on Primary compared, those where health care is one full day off a week. It should be noted Health Care held in 1978. That event was organised around the tenets of primary that Greece does not make use of the the first to put health equity on the inter- health care produce a higher level of heath option to derogate from the 48 hour week. national political agenda. for the same investment. The Greek authorities now have two The report critically assesses the way that It notes that in far too many cases, people months to reply. If further compliance health care is organised, financed and who are well-off and generally healthier with EU legislation is needed, the delivered in rich and poor countries have the best access to the best care, while Commission can send a reasoned opinion, around the world. It documents a number the poor are left to fend for themselves. and again Greece would have a further of failures and shortcomings that have left Health care is often delivered according two months to reply. Ultimately, if there the health status of different populations, to a model that concentrates on diseases, is no satisfactory reply, the Commission both within and between countries, high technology, and specialist care, with can refer the matter to the European dangerously out of balance. health viewed as a product of biomedical Court of Justice in Luxembourg. It can Speaking at the launch, WHO Director interventions and the power of prevention also request that the Court impose a fine General Dr Margaret Chan said that “the largely ignored. on the country if it does not comply. World Health Report sets out a way to Specialists may perform tasks that are The Working Time Directive is itself tackle inequities and inefficiencies in better managed by general practitioners, currently being revised under the co- health care, and its recommendations need family doctors, or nurses. This decision procedure. The Common to be heeded,” adding that “a world that is contributes to inefficiency, restricts access, Position, adopted by the Council in June, greatly out of balance in matters of health and deprives patients of opportunities for is now before the European Parliament. is neither stable nor secure.” comprehensive care. When health is Furthermore, the Commission is In a wide-ranging review, the report skewered towards specialist care, a broad currently finalising a detailed report on found striking inequities in health menu of protective and preventive inter- the implementation of the Working Time outcomes, in access to care, and in what ventions tends to be lost. Directive in all Member States. It is people have to pay for care. Differences in The report is available at planned for adoption in December 2008. life expectancy between the richest and http://www.who.int/entity/whr/2008/en Further information at poorest countries now exceed forty years. /index.html http://ec.europa.eu/employment_social/ Of the estimated 136 million women who labour_law/index_en.htm will give birth this year, around fifty-eight

Eurohealth Vol 14 No 3 44 MONITOR

‘Europe for Patients’ campaign from the whole Community market and programmes for drug users and the estab- On 30 September, Health Commissioner to take action against manufacturers. The lishment of intelligence-led police and Androulla Vassiliou launched the ‘Europe testing, certification and inspection bodies customs operations to counter large-scale for Patients’ campaign in Brussels. The that are involved in product checking will organised crime groups both in the EU campaign highlights the different health be subject to more stringent controls in and on the drug trafficking routes from policy initiatives the Commission intends the form of accreditation, to ensure that Afghanistan and Latin America. to adopt in the coming six to nine months. there is a level playing field both for The Action Plan 2009–2012 will be All the initiatives are bound by a common manufacturers and the inspection bodies. presented to the Council and is expected goal: better health care for all in Europe. Not all goods fall under Community to be adopted before the end of the year. They address patient safety, rare diseases, legislation. Many companies have found More information at organ donation and transplantation, it difficult to sell their products in other http://ec.europa.eu/justice_home/fsj/ cancer screening, the health workforce, Member States, and are discouraged from drugs/fsj_drugs_intro_en.htm influenza and childhood vaccination and venturing outside their domestic market antibiotic use. The first initiative, on cross due to the burden of proving that their COUNTRYNEWS border health care, was adopted by the products fulfilled the technical require- Commission in July. In launching the ments in the destination Member State. campaign the Commissioner stressed the Recognising this problem, the aim behind need to increase awareness across the EU the ‘mutual recognition principle’ is that Swedish focus on suicide prevention of the many positive impacts of EU health Member States will be prevented from On 14 July it was reported that the policies. She stated that “we need to stopping the sale of goods which have Swedish government had decided to make provide clear information, free of Euro- been lawfully marketed in another suicide prevention a priority in the jargon with real examples that relate to Member State. recently updated public health bill. The people’s lives.” aim is that no one should find themselves in a situation where they see taking their A webpage on the EU Health Portal in EU Drugs Action Plan for 2009–2012 own life as the only way out. twenty-two languages will become an On 18 September 2008, the Commission information hub where documents, adopted an ‘EU Drugs Action Plan’ for Each year, about 1,400 people take their articles and events will be posted. the period 2009–2012. The plan comes at own life in Sweden, which is about twice http://health.europa.eu/efp a time when the latest available data from as many lives lost as a result of traffic acci- the European Commission show that dents. Suicide is the most common cause Legal instruments underpinning EU’s whereas the use of heroin, cannabis and of death among people aged 15–44, albeit medical device directives adopted synthetic drugs has stabilised or is most suicides are committed by people In February 2007, the European declining, cocaine use is rising in a the aged over of 45. Preliminary estimates Commission proposed a new package of number of Member States. The total for 2007 indicate that 17.3 per 100,000 measures which were intended to boost number of people in the EU who use men and 6.9 per 100,000 women died intra-community trade in industrial goods drugs – or have at some time taken them from suicide. (the ‘new approach system’). These – is estimated at seventy million for Given that many suicides are avoidable, measures were designed to ensure that the cannabis, at least twelve million for the government decided on three schemes internal market became a reality for all cocaine, more than nine million for to help reduce intentional deaths. The first manufacturers and producers, and to ecstasy and eleven million for ampheta- targets young people. The Swedish make it easier for companies, especially mines, while at least half a million people National Institute of Public Health medium sized enterprises, to trade their are known to be receiving substitution (SNIPH), the Swedish National Agency products in the EU. On 23 June 2008, the treatment for heroin. There are up to two for School Improvement and the National European Council finally adopted this million problem drug users in the EU and Suicide and Mental Ill-health Prevention new package of measures. At the same around 7,500 people die of drug over- doses each year. Unit at the Karolinska Institute have been time it adopted measures dealing with the given the task of producing information ‘mutual recognition principle’ that The new Action Plan builds on the material on suicide prevention and a compliments the ‘new approach system’. existing approach of the EU Drugs strategy for disseminating the material to Strategy 2005–2012 which set out a The principle of free movement of goods teachers and school employees. European model for drug policy based on is one of the cornerstones of the EC a balanced approach to reduce both The second scheme targets health care Treaty. Many industrial products are supply and demand for drugs. The five personnel and other professionals, such as already subject to Community legislation main priorities of the new Action Plan police and criminal justice system and so can be traded freely within the EU. are: reducing the demand for drugs and personnel, who may come in contact with However, free trade must go hand-in- raising public awareness, mobilising people at risk of suicide. The SNIPH and hand with high safety standards. The ‘new European citizens, reducing the supply of the National Board of Health and Welfare approach system’ strengthens the drugs, improving international co- will propose ways in which to further framework within which the goods are operation and facilitating a better under- educate such professionals in suicide manufactured and traded, building upon standing of the drug phenomenon. prevention strategies. existing mechanisms, to ensure that only safe products circulate. Market surveil- Actions proposed include measures to In the third scheme, the government aims lance structures will be strengthened to improve the quality, availability and to improve public awareness of suicide catch unsafe products, to remove them coverage of treatment and harm reduction prevention. The National Board of

45 Eurohealth Vol 14 No 3 MONITOR

Health and Welfare will produce this said during a roundtable at the World over the last two decades, there still is a information, as well as a strategy for Bank office on 22 September in Moscow. “long way” to go. dissemination in cooperation with other Grishankov added that the Russian According to Billo, inadequate funding, organisations. government plans to allocate twenty-six insufficient management of DOTS, an billion Russian roubles, or about $1 increase in multi-drug resistant (MDR) UNICEF boosts funding to help ensure billion, from 2007 to 2011 for a TB TB and extensively drug-resistant (XDR) proper nutrition for Kyrgyz children prevention and treatment programme. TB, and a lack of infrastructure in devel- The United Nations Children’s Fund According to Grishankov, “social infec- oping countries to address MDR- and (UNICEF) will provide $270,000 in addi- tions” such as TB and HIV “pose a real XDR-TB are presenting challenges in tional funds to help develop a national threat” to Russia’s security because they meeting the United Nations’ Millennium nutrition strategy in Kyrgyzstan, where often affect people during their prime Development Goals and the Global Plan more than half of babies and infants are working years, at a time when the country To Stop TB: 2006–2015 targets. Billo anaemic and many young children suffer is experiencing a labour shortage. In called on France, Germany, the UK and from stunted growth as a result of addition, drug resistant TB is increasing the US to increase efforts to address TB nutrient deficiencies. in Russia and requires more expensive worldwide, saying they should “launch a “Giving a child a solid nutritional start in treatment than drug-sensitive strains of major financial rescue plan for TB.” life is critical to physical, mental and social the disease. Treatment for drug-sensitive Marcos Espinal, executive secretary of the development,” stressed UNICEF chief TB costs 2,500 roubles, or about $99, for Stop TB Partnership, said that drug- Ann Veneman during her visit to the six months, compared with 1.5 million resistant TB, HIV/TB co-infections and a Central Asian nation, the first-ever by an roubles, or about $60,000, for one year to lack of infrastructure are hindering health Executive Director of the agency. While treat drug-resistant TB. systems’ efforts to control TB. Mario in the capital, Bishkek, Ms Veneman also Grishankov recommended that Raviglione, director of the Stop TB visited the Rehabilitation Centre for government branches work together to Department at the WHO, said that the Street Children, which provides shelter control TB in Russia, noting that “poor global TB community needs to work for some seventy children who have been awareness of authorities and people is the “urgently” to improve health systems in exposed to violence, exploitation or main obstacle to development of an up- developing countries, adding that global abuse. She held talks with Prime Minister to-date comprehensive inter-agency targets on TB control cannot be met Igor Chudinov on a range of issues, programme”. without improvement in developing including the implementation of legis- countries’ health infrastructures. lation to protect the country’s children, as Most TB patients in Russia are classified Raviglione called for increased funding, well as the recent establishment of the as ‘socially vulnerable’, including people noting that although concerns about the new government department to co- who are alcoholics, homeless, migrants or global economy likely will affect TB ordinate children’s issues. unemployed. More than 300,000 TB cases funding, the global health community have been registered in Russia, which has More than half of the population in must still increase efforts to link TB a TB incidence of more than 100 cases per Kyrgyzstan – the second poorest country services with health systems in developing 100,000 people in twenty six regions. in Eastern Europe and Central Asia – lives countries. Nearby countries such as Finland, in poverty and more than one quarter in Norway and Sweden have a TB incidence The conference also heard that while extreme poverty, affecting more than 60% of five to six cases per 100,000 people. many of the twenty-two countries with of children under the age of fourteen. According to the WHO, Russia ranks the highest TB burden worldwide have Statistics show that at least 50% of 11th out of the twenty two countries with made progress in detecting and treating Kyrgyz babies aged between 6–24 months the highest TB burden worldwide and new cases, continued progress will require are anaemic and nearly 14% of children accounts for 35% of all primary TB cases coordination from entire health systems, under five suffer from stunted growth. in WHO’s European region. including better integration into primary UNICEF has been supporting activities health care. More information at in the country since 1994 in areas such as http://www.kaisernetwork.org/daily_ More information at http://www.kaiser- health and nutrition, clean water and sani- reports/rep_index.cfm?DR_ID=54604 network.org/daily_reports/rep_index.cfm tation, quality basic education for all boys ?DR_ID=55041 and girls, as well as the rights of margin- France: experts discuss integration of TB alised children, children in poverty and UK: Government action to fund gaps in services within primary care children facing discrimination. health research Tuberculosis experts discussed the inte- A new £5 million research programme More information at gration of TB services into primary health which is intended to lead to an increase in http://www.un.org/apps/news/story.asp? care and global progress in TB control at service quality and patient safety through NewsID=28608&Cr=KYRGYZ&Cr1= the ‘Stop TB Partnership’ symposium at better ways of planning and providing the 39th Union World Conference on health services was announced on 15 Russia: TB poses security threat in Lung Health on 16 October in Paris. Nils October by Public Health Minister Dawn Russia, official says Billo, executive director of the Interna- Primarolo, during a visit to Southampton. Tuberculosis (TB) poses a threat to tional Union Against Tuberculosis and Russia’s security and labour force, Lung Disease, said that despite the devel- The new Health Services Research (HSR) Mikhail Grishankov, first deputy chair of opment of stronger health systems and programme will provide funding across the security committee of the State Duma, better TB control in developing countries the country for a broader range of health

Eurohealth Vol 14 No 3 46 MONITOR services research than is already covered data to improve the planning and delivery cratic role. Instead they are being gagged by the National Institute for Health of health services and systems.” by the prejudice, ignorance and fear Research (NIHR) programmes: the surrounding mental illness. We look The first call for expressions of interest Efficacy & Mechanism Evaluation forward to the day when MPs from all will be taking place in January 2009. Programme, the Health Technology political parties with experience of mental Assessment Programme, the Service More information and details on how to illness are able to participate fully in our Delivery & Organisation Programme, register at http://www.hsr.nihr.ac.uk democracy.” Programme Grants for Applied Research More information on the survey can be and the Research for Patient Benefit UK: Almost one fifth of MPs have accessed at http://www.lynnejones.org. Programme. These are all specialist sub- experienced mental health problems. uk/survey%20FINAL.pdf sets in the field of health services research, The All-Party Parliamentary Group on which means that some projects may be Mental Health has found that 86% Channel Islanders could lose some difficult to fund as they fall outside estab- thought being an MP was stressful. The rights to free health care in the UK lished NIHR funding streams, as well as report criticises the law forcing MPs to Channel Islanders who fall ill or have those covered by the Medical Research give up their seats for life if they are accidents in the UK could soon be left Council and the Department of Health. placed into institutional care for six with huge medical bills if they do not have months under the Mental Health Act. No The HSR programme will fund research travel insurance. The necessity to take out mainly through a researcher-led work- such rules apply to MPs who are physi- comprehensive insurance is likely to be stream, whereby grants are provided for cally incapable of working for the same one consequence of the UK’s Department both primary and evidence synthesis on time period. of Health intention to withdraw from the topics proposed directly by researchers, Joint chairman Sandra Gidley said work reciprocal health agreement with the on an ongoing basis. The programme may on ‘challenging stigma’ was needed. Some Channel Islands of Jersey and Guernsey, also advertise calls for research proposals ninety-four MPs took part in the survey. as well as other off-shore jurisdictions, on specific topics. Dawn Primarolo said One in three said colleagues’ attitudes and including the Isle of Man and Gibraltar. “health services research produces the possibility of a hostile media reaction At the moment, islanders travelling to the knowledge that can lead to the prevented openness about mental health UK, and UK residents who visit the improvement of health policy, health issues. Ms Gidley, a Liberal Democrat Channel Islands are entitled to emergency systems, and health care delivery, ulti- MP, said that “greater openness at West- health care that is free at the point of mately resulting in improvements in minster about mental health problems delivery. Jersey’s health minister Ben population health. This area of research would have a significant impact in chal- Shenton said that the matter was still has already made a valuable contribution lenging stigma and discrimination”. under negotiation, and insisted that he did to the improvement of health and health not think that any change in the current care in the UK. With this new programme She pointed to the experiences of former agreement was imminent. we are taking action to fund important Norwegian Prime Minister’ Kjell Magne research where there is currently no alter- Bondevik, who publicly disclosed that he Under Jersey’s reciprocal agreement, native source of funding.” needed to take time off work because of which was established more than forty depression. She noted that his popularity years ago, the island pays the UK for The Government recognised the impor- was unaffected and indeed “he went on to services it uses in England, and the tance of health services research in its be re-elected and prove that people who Department of Health hands over cash to national health research strategy ‘Best have experienced mental health problems cover the cost of emergency treatment for Research for Best Health’, where one of can recover and manage a challenging UK residents visiting Jersey. The the strategic goals is to commission job.” taxpayers of both places ultimately pay research focused on improving health and for the services used, but they are free at care. The Cooksey review also high- Paul Farmer, chief executive of the charity the point of delivery for patients. lighted the need for increased funding for Mind, commenting on the survey said research into the implementation of new that “at a time when the government is The Department of Health’s position products and approaches into practice. appealing to employers to be more under- further strains relations between Jersey standing about mental health issues as and Westminster. In recent months the Commenting on the launch of the part of its aim to get people off benefits constitutional status quo has come into programme Professor Sally C Davies, and back into workplace, it seems they sharp focus as a result of the historical Director General of Research & Devel- should be looking to take action closer to child abuse inquiry, and calls for the UK opment at the Department of Health said home. Repealing antiquated rules that ban to step in to ensure that the court process that “all types of study designs appro- MPs from returning to work after recov- is fair to victims and those accused of priate to health services research will be ering from a mental health problem abuse. Whatever changes will be intro- supported, which include both primary would send out a clear message to all duced, the UK has made it clear that research and evidence syntheses. Our employers that discrimination should not Channel Island residents currently early work with stakeholders has high- be tolerated.” studying in the UK will be treated as UK lighted a number of key areas likely to be citizens for the purposes of their health of interest to this new programme. These Similarly the charity Rethink’s chief exec- care needs. include cultural and organisational issues utive, Paul Jenkins, said that the findings around patient safety, making better use were “an affront to democracy. MPs and More information at http://www.gov. of existing research knowledge through peers need to be free to bring their je/Health/who_we_are/Channel+Island modelling, and the use of existing health personal experiences to their vital demo- sReciprocalHealthAgreement.htm

47 Eurohealth Vol 14 No 3 News in Brief

Summit promotes joint commitment Updated Global Burden of Disease Meglena Kuneva said that “we need to to improve inclusion for millions of On 27 October the World Health Or- raise consumer awareness and put this Roma ganization published a new assessment information in the public domain. We On 16 September in Brussels the Euro- of the global burden of disease, a study need also to look again at the controls in pean Commission launched the first that provides a comprehensive picture of place, in the light of this scientific ad- EU-level summit devoted to improving the global and regional state of health. vice, to make sure they are fully effective the situation of Roma communities Drawing from extensive data, it features and keep pace with new technology.” across the Union. Discrimination against comparisons between deaths, diseases The Commission will hold a conference Roma people persists and 77% of and injuries by region, age, sex and in early 2009 in Brussels to evaluate the Europeans think that being Roma is a country income for the year 2004. It also Scientific Committee’s findings with disadvantage in Europe. In the Social provides projections of deaths and bur- Member States, industry, consumers and Agenda of 2 July 2008, the Commission den of disease by cause and region to the other stakeholders and to discuss the set out a renewed commitment to non- year 2030. The study contains details of way forward. The seminar will address discrimination in general and action to the top ten causes of death and estimates precautions that users can take, as well improve the situation of Roma in partic- for over 130 disease and injury causes. as technical solutions to minimise ular. It concluded that there is a power- hearing damage and the need for further More information at http://www.who. ful framework of legislative, financial regulations or revisions of existing safety int/healthinfo/global_burden_disease/ and policy coordination tools available standards to protect consumers. 2004_report_update/en/index.html at EU level and that these are increas- More information is available at ingly used, but that there is still an Improving cost-effectiveness in the http://ec.europa.eu/health/opinions/en/ implementation gap in the Member health care sector in Iceland hearing-loss-personal-music-player-mp3 States. The Summit forms the next step A new OECD working paper by in this process and aims to support and Hannes Suppanz argues that the high Report on inequalities in young promote a joint commitment by the costs of health care provision in Iceland people’s health Member States, the EU institutions and might be addressed by removing imped- A new report from the Health Behav- civil society. The conclusions will feed iments to private provision and opening iour in School-aged Children: WHO into discussions at the December 2008 up the health sector to competition. It Collaborative Cross-National Study European Council. suggests that introduction of cost shar- presents key findings on patterns of More information at ing where it does not exist (as in hospi- health among young people in forty-one http://ec.europa.eu/employment_social/ tals) might be considered, although countries and regions across Europe and fundamental_rights/roma/index_en.htm concerns about equity need to be taken North America. This report has a special into account. This it is argued would re- focus on health inequalities and indicates Progress in preventing injuries in the lieve the burden on public finances, as that, while the health and well-being of WHO European Region would the introduction of spending ceil- many young people are cause for cele- A new publication by D Sethi, ings, cost-efficiency analysis and activ- bration, sizeable minorities are experi- F Racioppi, B Frerick and N Frempong ity-based funding arrangements. The encing real and worrying problems from the WHO European Centre for high cost of pharmaceuticals might also related to overweight and obesity, self-esteem, life satisfaction, substance Environment and Health in Rome, be reduced by promoting competition misuse and bullying. It concludes that looks at the progress achieved by Mem- and the use of inexpensive generic drugs. policy makers and professionals should ber States on injury prevention. It re- The working paper is available at listen closely to the voices of young ports on the development of web-based http://www.olis.oecd.org/olis/2008doc. people and ensure that these drive ef- tools comprising a database of country nsf/LinkTo/NT00005C72/$FILE/JT032 forts to put in place the circumstances – profiles compiled through a question- 53001.PDF social, economic, health and educational naire survey and an inventory of na- – within which young people can thrive tional policies. Good progress is taking EU warns of permanent hearing and prosper. place, with the development of national damage from iPods policies for individual types of injury The report can be downloaded at Listening to personal music players at a and violence varying from 86% for road http://www.euro.who.int/Information high volume over a sustained period can safety to about 33% for the prevention Sources/Publications/Catalogue/ lead to permanent hearing damage, of youth and self-inflicted violence. The 20080616_1 according to an opinion of the EU report notes that the health sector needs Scientific Committee on Emerging and to commit to more widespread imple- Newly Identified Health Risks. The Additional materials supplied by mentation of effective programmes both scientific opinion shows 5–10% of those in number and coverage and to engage EuroHealthNet who listen to a personal music player for with other stakeholders in a multi- 6 Philippe Le Bon, Brussels. more than one hour per day each week sectoral response to prevent injuries. Tel: + 32 2 235 03 20 at high volume for at least five years risk Fax: + 32 2 235 03 39 The report is available at http://www. permanent hearing loss. In response, EU Email: [email protected] euro.who.int/document/E91710.pdf Consumer Affairs Commissioner

eurohealth Vol 14 No 3 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

European

on Health Systems and Policies

ISSN 1356-1030