Eurohealth Volume 14 Number 3, 2008 RESEARCH • DEBATE • POLICY • NEWS 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 Procurement of medical devices in England: application to wound care Reference pricing for medical devices in Germany Financing medical devices in Italy: cardiovascular technologies Medical devices: exploiting the potential in Europe
e-Health in Canada • Community pharmacy in the 21st Century • Development of a case mix system in JapanOTC pharmaceutical market – policy and practice • Cancer control in Europe • Health Insurance in Moldova
Procurement of medical devices inEngland: application to wound care
Reference pricing for medicaldevices in Germany
Financing medical devices in Italy:cardiovascular technologies
Medical devices:exploiting the potential in Europe
LSE Health, London School of Economics and PoliticalScience, Houghton Street, LondonWC2A 2AE, United Kingdomfax: +44 (0)20 7955 6090www.lse.ac.uk/LSEHealth
Anders Anell; Rita Baeten; Nick Boyd; Johan Calltorp;Antonio Correia de Campos; Mia Defever; Nick Fahy;Giovanni Fattore; Armin Fidler; Unto Häkkinen; MariaHöfmarcher; David Hunter; Egon Jonsson; Meri Koivusalo;Allan Krasnik; John Lavis; Kevin McCarthy; NataMenabde; Bernard Merkel; Stipe Oreskovic; Josef Probst;Tessa Richards; Richard Saltman; Igor Sheiman; ArisSissouras; Hans Stein; Jeffrey L Sturchio; Ken Thorpe;Miriam Wiley
Published by LSE Health and the European Observatoryon Health Systems and Policies, with the financial supportof Merck & Co and the European Observatory on HealthSystems and Policies.
Eurohealth is a quarterly publication that provides a forumfor researchers, experts and policymakers to express theirviews on health policy issues and so contribute to aconstructive debate on health policy in Europe.
The views expressed in Eurohealth are those of the authorsalone and not necessarily those of LSE Health, Merck & Coor the European Observatory on Health Systems andPolicies.
The European Observatory on Health Systems and Policiesis a partnership between the World Health OrganizationRegional Office for Europe, the Governments of Belgium,Finland, Greece, Norway, Slovenia, Spain and Sweden, theVeneto Region of Italy, the European Investment Bank, theOpen Society Institute, the World Bank, the London Schoolof Economics and Political Science, and the London Schoolof Hygiene & Tropical Medicine.
Medical devices, large and small, that are vital to thefunctioning of health care systems, are the focus ofmuch of this issue of Eurohealth. These devices are alsosignificant to the European economy: in 2005 alonethe European medical technology industry generatedsales of more than €63.6 billion, while investing morethan €3.5 billion in research and development andemploying 435,000 skilled workers. In their overviewarticle, Elio Borgonovi, Reinhard Busse and PanosKanavos argue that much more can be done tooptimise the value, effectiveness and efficiency ofmedical devices in Europe. They call for furtherevidence to demonstrate the numerous benefits arisingfrom investments in such technology, and, in parallel,to look at how the dynamics of coverage, procure-ment, reimbursement, and diffusion operate acrossdifferent health systems and regulatory environments.Contributions looking at different approaches andexperience in Italy, Germany and England also featurein this issue.
We are also delighted to publish an article by Delia-Marina Alexe and colleagues on the challenges posedby cancer in Europe today and the on measuresavailable to tackle this problem. They call for a muchmore integrated approach to cancer control, includingthe development of national coordinated cancer plans,as well as investment in effective cancer informationsystems including screening registries. At an EU levelthe authors note that the Data Protection Directivemay impede the effective operation of cancer registriesand requires reform, while further steps can be takento tackle health inequalities and promote strategies tocombat aspects of unhealthy lifestyles such as tobacco,alcohol and poor nutrition that are risk factors forcancer.
Among other contributions to the issue are twoperspectives on aspects of health reform from outsideEurope. One looks at the use of e-Health in Canadaand may be of significant interest to Europeancountries considering how best to expand their owne-Health systems. The second describes the challengeof introducing a case mix system to Japan, illustratingthe extent to which experience in Europe has helped toshape health policy in the country.
David McDaid EditorSherry Merkur Deputy EditorPhilipa MladovskyDeputy Editor
MENT
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Contents EurohealthVolume 14 Number 3
Tit Albrecht is Researcher in Health Services, Institute ofPublic Health, Ljubljana, Slovenia.
Delia-Marina Alexe is Clinical Research Fellow, HealthServices Research Unit, LSHTM, UK.
Michael Bäumler is Research Fellow, Berlin University ofTechnology, Germany.
Elio Borgonovi is Professor of Public Management,Bocconi University, Italy.
Christine Bond is Professor of Primary Care (Pharmacy),Centre of Academic Primary Care, Aberdeen, Scotland.
Reinhard Busse is Professor for Healthcare Manage-ment, Berlin University of Technology, Germany.
Giulia Cappellaro is Research Fellow, Centre forResearch on Health and Social Care Management,Bocconi University, Italy.
Michel Coleman is Professor of Epidemiology & VitalStatistics, Health Services Research Unit, LSHTM, UK.
Kenji Fujimori is based at the Division of MedicalManagement, Hokkaido University Hospital, Japan.
Kiyohide Fushimi is based at the Department of HealthPolicy and Informatics, Tokyo Medical and DentalUniversity Graduate School of Medicine, Japan.
Kohichi B Ishikawa is based at the Statistics and CancerControl Division, National Cancer Center, Japan.
Hideki Hashimoto is based at the Department of HealthEconomics and Epidemiology Research, TokyoUniversity, Japan.
Panos Kanavos is Senior Lecturer in International HealthPolicy, Department of Social Policy, LSE, UK.
Kazuaki Kuwabara is based at the Department ofHealth Care Administration and Management, KyushuUniversity, Japan.
Shinya Matsuda is based at the Department ofPreventive Medicine and Community Health, Universityof Occupational and Environmental Health, Japan.
Martin McKee is Professor of European Public Health,Health Services Research Unit, LSHTM, UK.
Sabine Meissner is Research Fellow, Berlin University ofTechnology, Germany.
Ricard Meneu is based at the Research Centre onHealth and Economics, Universitat Pompeu Fabra,Spain.
Denis Protti is Professor, School of Health InformationScience, University of Victoria, Canada.
Erica Richardson is Research Officer, European Obser-vatory on Health Systems and Policies, LSHTM, UK.
Jonas Schreyögg is Assistant Professor for Economicsand Management of Health Technologies, BerlinUniversity of Technology, Germany.
Ad Schuurman is Head of the Reimbursement Depart-ment, Dutch Health Care Insurance Board, Amsterdam.
Corinna Sorenson is Research Officer, LSE Health, LSE,UK.
Aleksandra Torbica is Assistant Professor in Public andHealth Care Management, Bocconi University, Italy.
Public Health Perspectives12 Cancer control in Europe today: challenges and policy options
Delia-Marina Alexe, Tit Albreht, Martin McKee, Michel Coleman
Medical Devices1 Financing medical devices in Europe: Current trends and
perspectives for researchElio Borgonovi, Reinhard Busse, Panos Kanavos
4 The procurement landscape for medical devices in England:Recent developments and applications to wound careCorinna Sorenson
7 Financing medical devices: The case of implantable cardioverterdefibrillators and coronary stents in ItalyGiulia Cappellaro, Aleksandra Torbica
9 Reference pricing for outpatient medical aids in GermanyMichael Bäumler, Jonas Schreyögg, Sabine Meissner,Reinhard Busse
Health Policy Developments16 Lampedusa and pharmaceutical distribution: community
pharmacy in the 21st centuryRicard Meneu
19 The over-the-counter pharmaceutical market – policy and practiceChristine Bond
25 Development and use of the Japanese case-mix systemShinya Matsuda, Kohichi B Ishikawa, Kazuaki Kuwabara,Kenji Fujimori, Kiyohide Fushimi, Hideki Hashimoto
30 e-Health in Canada: Lessons for European health systemsDenis Protti
European Snapshots33 Assessment for reimbursement: Collaboration at EU-level, the
MEDEV-experimentAd Schuurman
34 Moldova: Using social health insurance to reduce out-of-pocketpayments and improve equityErica Richardson
Evidence-informed Decision Making36 “Risk in Perspective” Ozone and mortality – an update
39 “Bandolier” Pharmacy care in older patients
Monitor41 Publications
42 Web Watch
43 News from around Europe
Identifying the optimal allocation ofavailable resources in order to maximisepopulation health gains has been andcontinues to be a key challenge for healthcare systems. One of the main perceiveddrivers of rising health care expenditureshas been the rapid pace of innovation inmedical technology.1 While medical tech-nology is not always cost increasing andthere are significant opportunities toreduce overall costs by adopting new tech-nologies, efficiency savings are frequentlyrealised with a significant time lag. Ascontinued advances in research areexpected to produce an ever-increasingnumber of alternatives for the detection,prevention and treatment of disease, newproducts will exert increasing pressure onhealth care policy makers to adoptmeasures to regulate the medical tech-nology market with regards to access,quality and public funding.
In order to be effective, such actionsshould take into consideration several‘biases’ historically applied to the medicaltechnology sector. The first bias concernsaccess to innovative technologies. Earlierstudies in health economics in the 1950sand 1960s showed that when new devicesbecame widely available there was ageneral overuse compared to initial calcu-lations or predictions based on approvedindications, suggesting potential inappro-priate use. These phenomena encouragednotably strict policies, signalling to policy-makers that they should be careful in theirdecisions regarding the financing of tech-nologies, especially the most expensive.
The second bias is related to the fact that,to date, policy measures applied to medicaltechnology have been in some wayconsidered similar to those pertaining topharmaceuticals. This is particularlyrelevant to cost containment policies
applied in the pharmaceutical sector, suchas reference pricing, price controls, andprice caps, among others.
Medical devices and pharmaceuticals:distant cousins, not twins!The second bias deserves particularattention. This is especially important in anera in which policy-makers have started toimplement measures to ensure the effec-tiveness and cost-effectiveness, often basedon health technology assessments (HTA),of medical devices. HTA and relatedstrategies are often founded on notions ofevidence-based medicine (EBM), wherebya range of evidence (for example, costs,efficacy, cost-effectiveness, equity)regarding a given technology is requiredby decision-makers to support adoption.However, EBM principles in general andHTA in particular, have principallyfocused on pharmaceuticals. Conse-quently, experiences with the pharmaceu-tical sector in this regard are oftenconsidered in the development of suchmethods and processes for medical devices.
However, is this ‘export’ of pharmaceuticalpolicies justified? The medical technologyindustry is largely, if not completely,different from drugs. There are severalreasons for this departure. First, in terms
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Financing medical devices inEurope:Current trends and perspectives for research
Elio Borgonovi, Reinhard Busse and Panos Kanavos
Summary: Medical technologies offer numerous benefits, in both health andeconomic terms. However, there is concern and a general lack of understandingabout how to best realise their ultimate value, effectiveness and efficiency inhealth care. The establishment of the European Health Technology Institutefor Socio-Economic Research (EHTI) aims to create a platform for researchand debate around these key issues, bringing together academia, industry, andpolicy-makers. This article discusses current trends and considerations in theregulation and financing of medical devices in Europe, outlines the principalobjectives of the Institute, and reflects upon the first year of research, whichfocused on the coverage, procurement, and reimbursement of selected medicaltechnologies in six EU countries.
Key Words: Medical Technology, Regulation, Financing, Health Care Systems
Elio Borgonovi is Full Professor of Public Management, Bocconi University, Milan, Italy.
Reinhard Busse is Professor and Department Head for Healthcare Management, andDean of the Faculty of Economics and Management, Technische UniversitätBerlin,Germany.
Panos Kanavos, is Senior Lecturer in International Health Policy, Department of SocialPolicy and Merck Fellow in Pharmaceutical Economics at LSE Health, London School ofEconomics and Political Science, United Kingdom. Email: [email protected]
of its structure, the medical technologyindustry is much more fragmented. Eventhough there are big multi-nationalcorporations, there are many moremedium and small companies in operationand it is true that the development of newmedical devices frequently takes place insmaller entrepreneurial companies. Thismay be a reflection of differences in thetwo industries in terms of risk perceptionand regulations, particularly in connectionwith the clinical development programme(extent, uncertainty and intensity offinancial resources) in the pharmaceuticalsector compared with medical devices.
Second, the significance of patents asincentives for innovation is influenced bythe different nature of Research andDevel-opment (R&D) in the pharmaceutical andmedical device industries.2 In pharmaceu-ticals, it is very difficult to design amolecule that simulates all the efficaciesand side effects of another drug; even if thiswere possible, patentability for twovirtually identical molecules would benearly impossible. However, this is not thecase with medical devices. A furtherdifference between drug and medicaldevice patents lies in which aspects of theinnovation lead to patentable claims. Inmedical devices, the basic principle can bepatentable, but specific devices usually arenot. In the pharmaceutical industry, it isoften just the opposite. Generallyspeaking, it is possible to design a newdevice for a specific application in anumber of different ways. The innovationoften lies in the underlying principle beingused in the particular application.
Third, the innovation process differssignificantly between pharmaceuticals andmedical devices. For the pharmaceuticalindustry, the key issue is to discover amolecule that, when demonstratedeffective for a certain illness, may immedi-ately become a blockbuster in terms of thereturn on investments made. The R&Dprocess is very long (approximately twelveyears), with the overall costs reachingseveral hundred million euros permarketed drug. The ‘me too’ phenomenon(i.e. the marketing of drugs with slightlymodified molecules, but similar effec-tiveness), is present but, in general, it haslimited effects on product development orwithin-product differentiation. Bycontrast, the innovation process formedical technology is incremental.Although there are some cases of break-through innovation, it is more typical toiteratively improve existing products in
their performance and safety. Moreover,medical devices often require ‘lead users’for their success (for example, operatingequipment needs to be accepted and usedby certain surgeons); the partnershipbetween technology producers/suppliersand health service delivery organisationsassumes an integral role in this process.
Fourth, and building upon the previouspoints, a further important differencebetween pharmaceuticals and devices liesin the ability and propensity to makechanges in the device product duringclinical evaluation and after it has beenmarketed.2 A pharmaceutical product isusually in its completed form prior tomarketing and is described by its chemicalformula; in most cases, dosage remainsstable during the life of the product. Incontrast, devices are constantly beingmodified to remove defects, improveperformance and add features throughoutthe product lifecycle. These changes occurfrequently and fuel competition amongmanufacturers, with a view to offeringbetter product performance and features.
As a result of the continuous productchanges that devices undergo, as well as thedifferences in the R&D process, it is hardlysurprising that the product life cycle in themedical device industry is much shorterthan that in the pharmaceutical industry,rendering individual medical devicesobsolete within a few years, comparedwith the statutory patent term (twentyyears) and marketing exclusivity periods(up to ten years) that apply to pharmaceu-ticals. For all of the above, there are goodreasons to believe that the ‘regulatoryapproach’ applied to the medical tech-nology sector should be different from thatemployed in the pharmaceutical sector.High-quality scientific research on theeffects of policy instruments transferredfrom the pharmaceutical sector willprovide the necessary evidence to policymakers to understand relevant differences.
The European Health Technology Institutefor Socio-Economic ResearchBased on this rationale, the EuropeanHealth Technology Institute for Socio-Economic Research (EHTI) was estab-lished in 2007.3 The idea of the EHTI wasbased on the aim of forming a collaborativenetwork of highly reputable academicinstitutions, Bocconi University (BU),Milan, Technical University (TU) ofBerlin, London School of Economics andPolitical Science (LSE), industry and thepolicy-making community. This is an
innovative model with several tangibleadvantages, including: (1) creation ofsynergistic effects between all partnersparticipating in the research process, (2)consideration of policy-makers’ needs and,(3) generation of evidence based on robustmethodology that may be useful tomultiple stakeholders and the researchcommunity. The Institute aims to becomeone of the principal actors in the Europeanhealth policy arena, leading the debatearound key issues affecting the viabilityand sustainability of the medical tech-nology sector and its link to societal healthand wealth.4 In this respect, it also aims tofill an important gap relating to the under-standing of medical technology, the impor-tance of R&D and the benefits accruing toboth patients and society.
Research objectivesFrom a research perspective, EHTI focuseson conducting and supporting high-quality empirical research on a range oftopics relevant to medical technology,including the value of innovation, qualityof life, quality of care, productivity,financing and reimbursement. In the firstyear of activity, the three universities havefocused their research on the financingmechanisms for, and access to, medicaltechnology in European countries.
Regulatory policies in general, andfinancing measures in particular, areconsidered important factors impacting onthe availability of, and access to, medicaldevices. It is therefore essential to addressthe issue of how medical devices arecurrently regulated and financed acrossdifferent health care settings in Europe, aswell as understanding who benefits frominvestments in medical technology. To thatend, the ultimate aim is to providesystematic, comparative evidence onregulatory policies across countries andtechnologies and to generate data on theimpact of adopted policies in terms oftechnology uptake and diffusion. Thisresearch fulfils an important role as theexisting literature has not yet sufficientlyaddressed these issues in a systematic way.
Since the early 1990s, market access formedical devices in Europe has been regu-lated through several EU directives. Thesedirectives must be transposed into nationallaw in each EU Member State. The EUdirectives specify the conditions that aproduct must meet in order to obtain theCE mark. With the CE mark a productmay be marketed in all EUMember States.The directives speed up the adoption
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process per se and, at the same time,provide a uniform definition for medicaldevices in the European Union. Againstthis background of European regulation,actual adoption and use in individualMember States depends mainly onwhether the medical devices are coveredby the (public) benefit baskets and howfinancial arrangements provide incentives(or otherwise) for their use.
Therefore, initial research by EHTIfocused on key issues relating to (a)coverage, (b) procurement and (c) reim-bursement of selected medical technologiesin six EU countries (Germany, Poland,Italy, Spain, the UK and France), repre-senting both the largest countries and amixture of North and South, tax-financedand insurance-based, decentralised andcentralised systems. The technologiesexamined were knee endoprostheses,implantable cardiac defibrillators (ICDs),coronary stents, laparoscopic colorectalsurgery, urinary incontinence pads and newwound care products (for example,negative pressure therapy).
The technologies were selected torepresent three sets of principle marketsfor medical devices:
1. Medical aids which are mainly given toand used by patients directly, (for example,incontinence products). These tech-nologies potentially constitute health carebenefits in their own right;
2. Medical devices which need to beimplanted into a patient (for example,stents, ICDs, or endoprostheses). Thesetechnologies entail only one component ofhealth care benefit (with hospital or ambu-latory services making up the othercomponents); and
3. Medical devices which are used toprovide services by physicians or otherhealth care providers (for example, laparo-scopic procedures). These are technologieswhere the service, not the device, repre-sents the health care benefit.
This distinction was developed in order toanalyse the key issues of coverage,procurement and reimbursement ofdevices beyond the peculiarities of the sixtechnologies. In terms of coverage, severalissues were investigated: whether the tech-nology was explicitly included in thenational/regional benefit basket orstatutory insurance schemes; the maindecision criteria for the inclusion/exclusion of the technology – separately oras part of a broader service; and, if and how
frequently the inclusion has been updatedfollowing progress with the technology.
Financing mechanisms were analysedalong two distinct dimensions: procure-ment and reimbursement. Procurement isconcerned with the ‘price’ of technologiesestablished between the producers andproviders of health care services (mainly inthe cases of 2 and 3 above) and the mainareas of investigation were: level of pricesetting and negotiation (centralised vs.decentralised procurement); existence of‘reference’ prices to be used in tendernegotiations; and criteria used in pricenegotiation. Finally, analysis of reim-bursement systems across countriesexamined different funding systems (tariff-based versus global budgets) and thedecision-making actors and level(s) atwhich funding is established (nationalversus regional level).
ResultsThe accompanying country case studyarticles present some of the results obtainedin this phase of research. One examines thefinancing of ICDs and coronary stents inItaly, while another explores recent devel-opments in the procurement landscape formedical devices in the UK, with a focus ontheir applications to wound care. Finally,the use of reference pricing – a typicalinstrument taken from pharmaceuticalpolicies – is assessed for outpatient medicalaids in Germany.
Conclusions and next stepsTechnological innovation is perceived tobe at the root of the recent cost escalationin health care. However, existing evidencesuggests that, on average, increases inmedical spending since 1960 and develop-ments in technology have provided value,leading to significant improvements inpatients’ quality of life, and reductions indisability levels and mortality rates.5,6 Yet,such benefits and the beneficiaries of tech-nological innovation, most notably inrelation to medical devices, have not beenadequately studied. As a result, evidence isneeded to demonstrate the numerousbenefits arising from investments inmedical technology and, in parallel, howthe dynamics of coverage, procurement,reimbursement, and diffusion of medicaltechnology operate across different healthsystems and regulatory environments.
With regards to the beneficiaries ofmedical technologies, it is important tobear in mind that a wider group, beyondpatients or health professionals, benefit
from medical technology and that thishealth gain is translated into economicsocietal gain.7 While it is clear thatinnovation, in general, contributes toeconomic development and welfareimprovements, the process wherebytechnological innovation in medicaltechnologies leads to growth and welfaregains is not well understood and wouldbenefit from empirical research. Indeed,the social and economic value of medicaltechnology is the current focus of a secondstream of research carried out by BU, theLSE and TU Berlin and which, in its initialphase, is aiming to produce a review basedon published and unpublished studies andreports made available within Europe andelsewhere in recent years.
It is hoped that EHTI’s research willexpand the existing knowledge baseregarding the effective uptake and use of, aswell as access to, medical technologies.Further, through its efforts, it is hoped thatstakeholders – academia, industry, andpolicy-makers – will collaboratively engagein debate and discussion on the key issueshighlighted throughout this article. Indeed,the unique contributions of medicaldevices, in both health and economic terms,need to be further understood, with theultimate aim of improving patient lives andsupporting continued medical innovation.
REFERENCES
1. Fuchs V, Sox H. Physicians’ views of therelative importance of thirty medical inno-vations. Health Affairs 2001;20(5):30–42.
2. Gelijns AC, Halm EA (eds). TheChanging Economics of MedicalTechnology. Washington DC: NationalAcademy Press, 1991.
3. The European Health TechnologyInstitute for Socio-Economic Research(EHTI) (2007). Available athttp://www.together4healthinnovation.eu
4. Suhrcke M, McKee M, Sauto Arce R,Tsolova S, Mortensen J. The Contributionof Health to the Economy in the EuropeanUnion. Brussels: Commission of theEuropean Communities, 2005.
5. Cutler DM, Rosen A, Vijan S. The valueof medical spending in the United States,1960–2000. New England Journal ofMedicine 2006:355;920-927.
6. Cutler DM. The lifetime costs andbenefits of medical technology. Journal ofHealth Economics 2007;26(6):1081–100.
7. Gandjour A. The economic value ofmedical technology. Health Affairs2002;21(1):275–76.
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Numerous programme and policy initia-tives have been introduced in Englandsince the late 1990s to support the effectiveuse of National Health Service (NHS)funding in providing accessible and inno-vative health care. As the 2002 WanlessReport1 highlighted, investments in inno-vative medical technology are an importantcomponent of NHS planning to maintainan efficient and high-quality health serviceand drive socioeconomic benefits. Conse-quently, the process by which the NHSpurchases and introduces innovation intoits system of hospitals and GP practices iscrucial to realising the numerous benefitsafforded by medical technologies.
In particular, several actions have beenrecently instituted into the procurementlandscape for medical devices in the NHS.Such change was arguably first initiated bythe development of the Supply ChainExcellence Programme (SCEP), whichsought to improve methods of bothnational and regional procurementthrough various mechanisms, such as
collaborative ‘procurement hubs’,National Contracts Procurement (NCP),and reorganisation of the role of the NHSPurchasing and Supply Agency (PaSA).The latter now has responsibility fordevice evaluation and outsourcing of NHSLogistics – a ‘joined-up’ effort deemed theNHS Supply Chain, which serves as theprimary purchasing agent for the NHS.Other changes to the governance structurewere realised, with the multi-nationalcompany, DHL, and US-based purchasingorganisation, Novation, overseeing oper-ation of the Supply Chain, in collaborationwith the NHS Business Services Authority(NHSBSA). The SCEP was recentlysucceeded by the NHS Sourcing andSupply Chain Improvement Programme(NSSCIP), which aims to continue manyof the SCEP’s key objectives (for example,use of purchasing hubs).2
The legacy of SCEP and associated devel-opments on NHS procurement isuncertain. With a greater commercialorientation, the Programme increased thefocus on bulk purchasing and a compet-itive tendering process. While such prac-tices can have positive implications forefficiency gains and reduced prices, thishas lead, in some cases, to the purchase of
cheaper and often older equipment fromlarge suppliers, who can more easilyaccommodate NHS demands for lowprices and high volume. This can providedisincentives for innovative products to bedeveloped and available to patients andproviders, in addition to disproportion-ately orienting objectives towards short-term cost-savings, rather than long-termbenefits and costs.3 While costcontainment is certainly a key objective ofany health care system, procurement deci-sions and practices should be grounded inproviding greatest benefits to patients andproviding the best value for money for the£15 billion spent each year by the NHS ongoods and services.
Evidence-based purchasingTo help meet this objective, recent changesencompassed the development of a newdevice evaluation service, the Centre forEvidence-Based Purchasing (CEP), withinNHS PaSA. The Centre was established toprovide evidence to underpin purchasingdecisions and, more broadly, to supportthe uptake of effective, safe and innovativeproducts and related procedures in healthcare. While evaluation of medical tech-nology has historically rested on evidence
The procurement landscape formedical 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 generalpractitioner practices is crucial to realising the numerous benefits afforded bymedical technologies. Several actions have recently been instituted into theprocurement landscape for medical devices in England, including developmentof collaborative ‘procurement hubs’, National Contracts Procurement and reor-ganisation of the roles of key purchasing bodies, all principally under the auspicesof the Supply Chain Excellence Programme. While most of these initiativesgenerally focus(ed) on short-term cost containment and efficacy gains, it hasbeen argued that procurement decisions and practices should be increasinglygrounded in providing greatest benefits to patients and providing the best valuefor 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
Corinna Sorenson is Research Officer,LSE Health, London School of Economicsand Political Science, UK.Email: [email protected]
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of performance and safety, the CEP and itsprogrammes, such as theMultidisciplinaryAssessment of Technology Centre forHealthcare (MATCH)* , aim to incor-porate considerations of costs, patientoutcomes and clinical opinion into aprocurement framework. As promulgatedby these initiatives, such evidence could beused to inform procurement contractagreements and determine appropriatepricing bands for applicable tariffs.
While the principal objectives of evidence-based purchasing (EBP) are laudable andincreasingly needed to support value formoney in the NHS, it is still in anembryonic stage of development.Moreover, similar to other procurementdevelopments, EBP presents challenges forhighly innovative or new technologies inthe early stages of commercialisation. Inparticular, the data or evidence required forthe evaluation of medical devices are oftenunavailable, as unlike pharmaceuticals,randomised controlled trials are notrequired for market approval. Even in caseswhere data are available for early evalu-ation, evidence is unlikely to appropriately
account for the incremental developmentof most medical technologies. Indeed,devices are typically developed through adynamic, iterative process, whereby theirfunctionality is constantly improved uponby user feedback and further research. Thisresults in the evolution of new generationsof the initial device, leading to differentcharacteristics, outcomes and costestimates with each progressive iteration.To this point, evaluation prior toprocurement, either at first generation orbefore user feedback can be assessed, maynot fully or accurately capture the truevalue of a given technology.
Application to wound careRecent innovations in wound care, partic-ularly Vacuum-Assisted Closure (VAC)therapy**, provide a helpful example toillustrate some of the opportunities andchallenges associated with application ofEBP in the NHS. VAC therapy is a rela-tively immature and highly innovativeintervention that applies negative pressureto accelerate wound healing. It employselectrically-powered vacuum pumps,
collection canisters, connection tubes andspecialised dressings to drain wounds ofexudate (i.e. excess fluid and cells) andinfluence growth of surface tissues. Todate, VAC therapy is primarily used foracute (e.g. skin grafts) and chronic (e.g. legulcers) wounds of variable size andcomplexity, and is employed in bothhospital and community care settings.While still an early product, the benefits ofVAC therapy for wound care patients areconsidered high, in terms of woundhealing, cost-effectiveness, and reducedlength of stay. Currently in the NHS,purchasing activity for VAC therapy ispredominated by NHS Trusts (devices)and the NHS Supply Chain (consum-ables). Procurement decisions areprimarily comprised of two main choices,purchase or rent, which is mainly deter-mined by specialist nurses and clinicians.Figure 1 maps the procurement landscaperelated to VAC therapy.
Increased demand and its innovativenature have placed VAC therapy on theprocurement agenda in the NHS.However, decision-makers are often
*TheMATCHprogramme 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 – allwith their own important perspectives regarding medical technologies.
** Included in general category of Negative Pressure Therapy for wound care.
Figure 1: Procurement mapping of Vacuum Assisted Closure (VAC) therapy
Acute Trust/Hospital
ABHI
PCT
Patient
DistrictNurse
Directorof Nursing
ConsultantsGeneral& ServiceManagers
Royal Collegeof Nursing
Head ofProcurement
NHS SupplyChain
Evaluation Centre
WoundHealingResearchUnit
Variousspecialistnurses
SHA
ManufacturerCollaborative
Procurement Hub
DOH
NICE
PaSA
CEP
grounding purchasing activity on mixed orlimited evidence. This is principally due toconsiderations regarding data availabilityfor new and notably innovative therapiesand, perhaps, as a result of insufficientresources allocated to adequately assess theexisting evidence on the costs and benefitsof VAC therapy. Wound care itself alsointroduces challenges that can impact ontheir evaluation and, subsequently, EBP.For instance, wound care is highly variableacross wound type and characteristics,frequency of dressing changes andduration of treatment. Moreover, there arefew ‘standard’ or ‘conventional’ productsin this therapeutic area, as evidenced by thevariety of innovative wound treatments onthe market and the presence of inconsistentlocal clinical guidelines on use in patientcare.
Outstanding issuesIn order to address some of the issuesrelated to VAC therapy and facilitate theeffective use of EBP, especially in highlyinnovative therapies, there are a number ofoutstanding issues that need to beaddressed. Firstly, systematic review ofavailable evidence and/or economicanalyses, including modelling, needs to bepursued. Given it is a fairly immaturetherapy, there may be limited data and,where evidence is available, methodologicalissues (for example, small sample sizes,variation in outcomemeasurement) may bepresent. This may be exacerbated by thelack of clarification as to what constitutesstandard wound care. Such challenges mustbe acknowledged and addressed throughadditional evidence and consideration ofnew data as it becomes available. MATCHis addressing some of these methodologicalissues by incorporating different analyticalapproaches, for example, Bayesian tech-niques, into value-assessment methods forthe purposes of procurement.
Secondly, as demonstrated by the exampleof VAC therapy, there are a vast range ofactors involved in the procurementprocess. To ensure national and local rele-vance and cross-stakeholder engagement,collaboration is needed amongst key stake-holders, including industry, the Associ-ation of British Healthcare Industries(ABHI), the Department of Health(including the National Institute forHealth and Clinical Excellence – NICE),procurement actors (for example, collabo-rative procurement hubs, Trust Managers,Directors of Nursing) and users of thetechnology. These key stakeholders shouldbe involved in lending valuable multiple
perspectives, in addition to pure cost-minimisation considerations, whichcurrently tend to dominate purchasingdecision-making. In particular, stake-holders both inside and outside the NHScould contribute input regarding how:(a) different elements of procurementinteract, (b) patient needs can be achieved,(c) innovation can be better integrated intothe NHS, and (d) industry can berewarded for high-value products. Interms of NICE in particular, it will proveimportant to carefully assess howevidence-based purchasing decisions (and,evaluative processes) may coincide withthe Institute’s decisions and guidance. Theinformation provided through interactiveand iterative communication routes facili-tates parallel benefits for improvedpurchasing decisions, continuous devicedevelopment and enhanced managementof wound care in the NHS.
Thirdly, as the concept and use of EBPdevelops in England, the unique consider-ations of innovative devices must be takeninto account, many of which have beenhighlighted throughout this article. Theseinclude, but are not limited to, the method-ological challenges associated with earlyevidence and technologies intended forsmall patient populations; the iterativedevelopment curve; and the high cost andresource needs of distribution and usertraining and education. To that end,devices, as compared to pharmaceuticals,require a significant level of userinvolvement, which ultimately has impli-cations for the performance (i.e. effec-tiveness, safety) of the product. Themedical technology industry is typified bysmall companies, who may lack thenecessary resources to amass the infor-mation required by CEP or other relevantEBP bodies. Fourthly, similar to any eval-uative process for determining the value ofnew health technologies, the transparencyof EBP-based procurement decisions must
be upheld. As NHS procurement assumesa commercial element and often involves avast array of transactions, an open processis necessitated.
The procurement landscape in England hasundergone notable transformations, intro-ducing various policies and mechanisms toenhance the value for money achieved inNHS purchasing. EBP, marked by theestablishment of the CEP, is one particularstrategy to meet this aim. While EBP mayhelp shift focus from short-term gains tosustainable cost and outcomes in NHSpurchasing, adequately accounting forinnovation and differences between tech-nologies (i.e. devices vs. pharmaceuticals)in its practices and methods is crucial.Furthermore, requisite resources should beinvested in the CEP to ensure an effectiveand robust process and, importantly, onewith an impact on procurement. Indeed,purchasing practices and policies shouldultimately support the founding principlesof the NHS – providing patients withhigh-quality, effective, and affordablehealth care.
REFERENCES
1. Wanless D. Securing Our Future Health:Taking A Long-Term View. London: TheStationery Office, 2002. Available athttp://www.hm-treasury.gov.uk/Consultations_and_Legislation/wanless/consult_wanless_final.cfm
2. NHS Purchasing and Supply Agency.Business Plan 2007/2008. Reading: NHSPaSa. Available athttp://www.pasa.nhs.uk/PASAWeb/NHSprocurement/AboutNHSPASA/Publications/Corporatepublications.htm
3. Department of Trade and Industry.Competing in the Global Economy: TheInnovation Challenge. DTI: InnovationReport. London: Department of Trade andIndustry. Available at:http://www.berr.gov.uk/files/file12093.pdf
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Conference: Bridging Knowledge in Long Term Care and Support
La Pedrera de Caixa Catalunya, Barcelona 5–7 March 2009
In Europe over 15 million people with disabilities will soon enter old age, while a similarnumber of older people will become disabled. This conference will explore methods andsystems for long-term care and support, in particular looking at how to integrate andtransfer knowledge and experience between the ageing and disability sectors.
Supported by the European Commission, it will feature a mix of keynote speeches byinternational experts and parallel symposia.
Early registration closes on 15 December 2008. Further information on the conferenceprogramme, abstract submission and registration at:http://obrasocial.caixacatalunya.es/osocial/main.html?idioma=3
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MEDICAL DEVICES
The financing of medical devices has onlybecome an important agenda item forItalian health policy makers in the last fewyears. In fact, with the exception of severallaws adopted to simply transpose EUdirectives on market access regulation, nosignificant policy measures were takenuntil 2002. The main reason for theincreased attention is undoubtedly linkedto the economic and financial sustain-ability of the system. Medical deviceexpenditure accounts for almost 6% ofoverall health care expenditure in Italy, oraround € 4 billion per annum.1 Further-more, the rapid pace of innovation in thisarea has raised the level of debate over thebest ways in which to guarantee equalaccess to new medical devices and at thesame time ensure the long-term financialsustainability of the Italian NationalHealth Service (NHS).
Among several policy measures adopted
between 2002 and 2008, three merit specialattention: the creation of the MedicalDevice Committee, development of anational database of medical devices andthe implementation of a system ofreference pricing. The 2003 Financing Lawestablished the Medical DevicesCommittee (Commissione Unica suiDispositivi Medici-CUD). Its main objec-tives were to create a national database ofmedical devices currently available on themarket (Repertorio Nazionale) and tosubsequently update this on a regular basistaking account of clinical and economiccriteria. This national database becamefunctional in May 2007 and, from January2009, only devices described therein maybe purchased, used or distributed withinthe Italian NHS. The 2007 Financing Lawalso introduced reference prices for a listof selected medical devices that should beused in procurement arrangementsbetween medical device producers andhealth service providers. A MinisterialDecree on 11 October 2007 defined thefirst medical devices to be affected byreference pricing and includes, forexample, coronary stents and hip endo-prostheses components.
Following this short overview of recentpolicy measures, we now investigatecurrent procedures for the procurement
and reimbursement of medical devices inItaly. To achieve this we focus on two tech-nologies: implantable-cardioverter defib-rillators (ICDs), used for the prevention ofsudden death due to arrhythmia in patientswith acute myocardial infarctions, andcoronary stents used in percutaneouscoronary interventions (PCI) for patientswith ischemic hearth disease. Theprevention and treatment of cardiovasculardiseases is the most important clinical areato consider, both in terms of impact onoverall health care expenditure and the rateof innovation in medical devices used fortreatment and diagnosis.
Diffusion of ICDs and coronary stentsEmpirical data suggest that the use of bothof these technologies has significantlyincreased in recent years. The recentlyestablished National Registry for ICDsrevealed that approximately 10,400 ICDSwere implanted in 2005, almost 60%morethan in 2004.2 This equates of a ratio of 179implants per million population; acrossEurope this ranges from 67 per million inPortugal to 262 per million population inGermany.3 The significant increase in Italyshould be interpreted with caution due todifferences in data. It can only partially beexplained by the larger use of ICDs inprimary prevention. Different types of
Financing medical devices:The case of implantable cardioverterdefibrillators and coronary stents in Italy
Giulia Cappellaro and Aleksandra Torbica
Summary: In the recent years, the financing of medical devices has gainedincreasing attention from health policy makers in Italy at both regional andnational level. The article investigates the current modalities of procurementand reimbursement of cardiovascular medical devices in Italy, as well astheir diffusion across the country. Both implantable cardioverter defibril-lators and coronary stents are purchased by health care providers throughopen public tenders and are prospectively reimbursed using DiagnosisRelated Group tariffs. Empirical data suggest that these technologies haveincreasingly been used in recent years in Italy.
Key words: Health Care Financing, Medical Devices, Reimbursement, Italy
Giulia Cappellaro is Research Fellow atthe Centre for Research on Health andSocial Care Management, BocconiUniversity, Milan, Italy. AleksandraTorbica, is Assistant Professor in Publicand Health Care Management, BocconiUniversity, Milan, Italy.Email: [email protected]
ICDs can be used, they can vary by thetype of pulse generators they use. Lookingat first implants and replacement interven-tions tri-chamber ICDs account for 37%of all implantations compared to 32%using dual chamber and 30% singlechamber ICDs.
Turning to coronary stents, data on activityin catheter laboratories in Italy4 highlightthe significant increase in the total numberof PCI procedures from approximately65,000 in 2001 to 125,000 in 2006 (Figure1). This increase can partially be explainedby improvements in both diagnostic andtherapeutic procedures that have expandedthe number of patients eligible for theprocedure. Technological innovation (i.e.the introduction of coronary stents) isundoubtedly one key factor. In fact, theincrease in PCI procedures with coronarystents has grown faster than the number oftotal PCIs (with and without stents) duringthe same period increasing from 81.6% ofall PCIs (53,411 procedures) in 2001 to92.5% in 2006 (114,799 procedures). There
are several types of stents, for example,drug eluting stents (DES) and bare metalstents (BMS). DES now account for 56%of all stent procedures compared with 18%in 2003 when they were first introducedonto the Italian market.
Procurement – financial arrangementsbetween producers and providersBoth ICDs and stents are purchased byhealth care providers through open publictenders. Negotiations take place atprovider level, even though centralisedprocurement strategies have been enactedat both regional and inter provincial level.Public tenders are usually assessed on thebasis of cost; with the price/quality criteriaratio varying from 40/60 to 50/50. Giventhe rapid pace of innovation in thiscategory of devices, quality criteria areusually based not only on the technicalevaluation of the device, but also on theresults of clinical studies, research anddevelopment programmes and, in case ofselected innovative products, the quality ofsamples provided by the manufacturer.
Before the recent introduction of referenceprices, aimed to put a cap on the cost ofbids in public tenders, price negotiationswere free. Even though both technologies,ICDS and stents, will eventually beaffected by this measure, only coronarystents were included in the initial list ofdevices with reference prices (Table 1).
Reimbursement measuresIn Italy, given that all medical devices areimplanted on an inpatient basis, ICDs andstents are prospectively reimbursedthroughDRG tariffs. From 1 January 2006a newDRG classification system (Grouper19) was adopted nationwide. This changehas influenced the reimbursement of bothICDs and coronary stents, since it definedthree new DRGs specific to these devices.ICDs are currently reimbursed throughDRGs 514 and 515 – cardiac defibrillatorimplant with/without cardiac catheteri-sation. Coronary stents are included inDRG 517 – percutaneous interventions forthe cardiovascular systemwith insertion ofstent in the coronary artery withoutinternal mammary artery.
The different Italian regions are entitled toadopt different policy measures to regulatereimbursement mechanisms for medicaldevices.5 The variability of regional reim-bursement systems plays a significant rolein the use of cardiovascular implantabletechnologies. Some regions reimburse apercentage of the cost of the device(Lombardy, for instance, recognises 30%of the average weighted regional costs ofICDs and 50% of DES) or on the basis ofthe specific list price such as in Puglia,whereas other regions, mainly Campaniaor Sardinia, provide a fixed top-up toDRG tariffs for devices.
Discussion and future perspectivesIn recent years, the financing of medicaldevices has gained increasing attentionfrom health policy makers in Italy at bothregional and national level. From themeasures adopted, it appears that nationalpolicy makers have focused their attentionon cost containment policies by estab-lishing the maximum prices for devicesthat can be used in tender negotiations. Itis still too early, however, to quantify theeffects of the introduction of nationalreference prices in Italy. Furthermore, thegovernment has recently recognised thetemporary nature of reference prices andthe need to identify complementary cost-containment alternatives; nevertheless noofficial policy measures have, to date, beenadopted.
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0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
2001 2002 2003 2004 2005 200680%
82%
84%
86%
88%
90%
92%
94%
96%
98%
100%
% PCI with stent / total PCI
Total PCI
PCI with stent
Figure 1: Diffusion of PCI procedures and coronary stents in Italy
Source: Calculations, based on data of GISE (www.gise.it)
The regional health authorities, on theother hand, have mainly concentrated ondefining different reimbursement policiesto control costs. Even though significantprogress has been made in the recent years,the current classification system does notallow for differentiation between differenttypes of ICD or coronary stent that couldpotentially hinder the diffusion of inno-vative devices. Data highlight regionalvariability in the diffusion of both tech-nologies, but the hypothesis that this is dueto different reimbursement schemes stillneeds to be tested empirically.
Given the increasing attention of Italianpolicy makers to the definition of policiesin the medical device sector, newmeasuresare likely to follow. The effectiveness ofthese policies will greatly depend on thesuccess of coordination between thenational government and the regions, sincethe major critical feature of the ItalianNHS remains the distribution of powersbetween the two levels.
REFERENCES
1. Directorate General for Drugs andMedical Devices. Dispositivi Medici. AspettiRegolatori e Operativi [Medical Devices:Regulatory and Operational Factors]. A curadella Direzione generale dei Farmaci eDispositivi Medici del Ministero dellaSalute. Rome: Ministry of Health, 2007.
2. Associazione Italiana di Aritmologia eCardiostimolazione. Registro Italiano Pace-maker e Defibrillatori. Bollettino Periodico2005. [Italian Registry of Pacemakers andDefibrillators. Bulletin 2005] GiornaleItaliano di Artimologia e Cardiostimo-lazione 2006;9(3).
3. Peinado R, Torrecilla E, Ormaetxe J,Alvarez M. Registro Espanol de desfibri-lador automatico implantable. III InformeOficial del Grupo de Trabajo de Desfibri-lador Automatico Implantable de laSociedad Espanola de Cardiologia. [SpanishICD Registry. Third official report of theSpanish Society of Cardiology WorkingGroup on ICDs]. Revista Espanola deCardiologia 2006;60(12):1290–301.
4. Societa Italiana di Cardiologia Invasiva.Attività dei Laboratori Italiani di Emodi-namica. I dati delle attività – 2003, 2004,2005, 2006. [Annual activity of Italian hemo-dynamic laboratories 2003–2006] Availableat http://www.gise.it/
5. Fattore G, Torbica, A. Inpatient reim-bursement system in Italy: how do tariffsrelate to costs? Health Care ManagementScience 2006;9:251–58.
Contributions to German Social HealthInsurance (SHI) are paid in equal part byemployers and employees as a proportionof salary. As the employers’ payments arethought to be one of the reasons for highunemployment rates in Germany,endeavours to lower these costs, or at leastto fix them at their current level, have beenmade. In the ambulatory and hospital caresectors, expenditures have generally beencontained by tying changes in reim-bursement to changes in contributoryincome. For the cost containment of phar-maceutical expenditure, a range of moreand less successful instruments, includingregional and physician-specific prescrip-tion caps as well as reference prices (since1989), have been used.
Thus, the temptation was great to also usethis reimbursement system in the marketfor medical aids (i.e. medical devicesprescribed in ambulatory care for use by
patients), as the ‘sector’ medical aids and‘services by non-physicians’ (for example,physiotherapy) was one of the fewremaining sectors with visible expenditureincreases – nota bene, in official statisticson SHI expenditure, the two groups arealways given together so that the overalldevelopment was extrapolated to both.
We aimed to analyse if there is evidencethat the introduction of nationwidereference prices for certain groups ofmedical devices led to decreasing SHIexpenditure, in comparison to whathappened in the pharmaceutical marketwhere we judged this to be quitesuccessful.1 To do this we examined asample of administrative data on spendingon medical aids.2–5 of the GmünderErsatzKasse (GEK). This is one ofGermany’s largest sickness funds whichinsures about 1.65 million people.
Definition of reference prices inGermanyThe German reference price system doesnot set fixed prices but instead limits whatmay be reimbursed by the sickness funds.For products with prices higher than thereference price, the insured individual hasto pay the difference between the referenceprice and the price set for manufacturer/distributor reimbursement. The reference
Reference pricing foroutpatient medical aids inGermany
Michael Bäumler, Jonas Schreyögg, Sabine Meissner andReinhard Busse
Summary: German reference prices define a limit for reimbursement by sicknessfunds for certain categories of products. In 2005 a nation-wide reference pricesystem for six of thirty-three categories of medical aids was introduced. Prior tothis, reference prices had only existed for these categories in some of the GermanLänder. A data sample provided by a large German sickness fund indicateddecreasing expenditure in five categories after the introduction of the new systemwhile expenditures for one category increased. However, a judgement on theefficacy of reference prices seems to be difficult as there were both different startingpoints for reference prices in the Länder and other factors influencing expenditure.
Keywords: Reference Prices; Medical Aids; Germany; Expenditure
Michael Bäumler and Sabine Meissner areResearch Fellows, Jonas Schreyögg isAssistant Professor for Economics andManagement of Health Technologies andReinhard Busse is Professor for HealthCare Management all based at BerlinUniversity of Technology, Germany.
prices include value added tax and all costsarising from the delivery of medical aids.
Reference prices for medical devicesdemand the same requirements as pharma-ceuticals. They have to guarantee a suffi-cient, appropriate and efficient, as well asquality-assured provision of medicaldevices. Reference prices aim in principleto mobilise efficiency reserves and stim-ulate effective price competition.Therefore, the price should preferably beorientated towards reasonably pricedgoods and services. Sickness funds arerequested to make use of public tenders inrespect of medical devices that are notsubject to reference-pricing.
Introduction of reference prices formedical devicesReference prices for medical devices werefirst established under the 1989 HealthCare ReformAct.6 Visual and hearing aidswere reference-priced in all federal states(Länder), whereas devices for decubitus,arch supports, incontinence aids andostomy procedures only received referenceprices in some of them. The prices itselfwere defined by the different regionalassociations of the sickness funds.7
When the SHI Modernisation Act (GMG)came into effect in 2004, the federal associ-ations of the sickness funds were requiredto set nationwide reference prices for thefirst time. The first came into effect on 1January 2005 for the following six (of atotal of thirty-three) categories of themedical aids catalogue: arch supports, tech-nical aids for compression therapy, visualand hearing aids, absorbing and drainingincontinence aids and ostomy procedures.
The setting of reference pricesIn a first step, reference price groups areformed by the federal associations ofsickness funds for products of homoge-neous and equivalent functionality on thebasis of the classification of the respectiveproduct groups within each category in thecatalogue of medical aids.6 This is clearlyan important precondition as groups withheterogeneous products of different func-tionality would have a clear potential forinappropriately steering the usage of oneproduct over the other. Forming groupswith the aim of calculating reference pricesis therefore confined to groups wherehomogeneity can be reasonably safelyevaluated or assumed.
In a second step, reference prices are set foreach group by the associations of sicknessfunds. Manufacturers and organisations
representing people with disabilities thenhave the opportunity to issue statementsthat have to be taken in consideration inthe process of grouping aids for referencepricing and in the process of setting pricelevels. These reference prices are thenassessed at least once a year and adjustedas appropriate to take account of marketconditions.8 It is important to note thatcategories may encompass a large numberof product groups, i.e. a reference price isnot set for a whole category but for eachindividual product group: for example,ostomy currently encompass thirty-oneproduct groups, with reference pricesranging from €111.47 to just €0.04.
ImpactFigure 1 illustrates relative expenditure perinsured person in the GEK between 2003and 2006 inclusive, i.e. before and afternation-wide reference prices were intro-duced in 2005, with 2004 as the index year.These expenditures decreased dramaticallyfrom €9.27 per insured individual in 2003and €3.81 in 2004 to only €0.91 and €0.81in 2005 and 2006 respectively.
The expenditures for all categories withreference prices (with the exception ofvisual aids which are not included in theanalysis as reference pricing already existedon a nationwide basis) increased in 2004 bybetween 10% (hearing aids) and 5% (archsupports). After the introduction ofreference prices, expenditure fell both in2005 and 2006, save for incontinence aids,a category for which reference prices wereinitially not set for all product groups
(Table 1). In contrast, while expenditure onother medical aids not falling under thereference price scheme decreased between2003 and 2004, it again increased in 2005.As Figure 1 illustrates while there was a fallin 2006, this group continued to havehigher levels of per capita expenditurecompared with medical aids in thereference pricing groups.
Conclusion and perspectivesIt is difficult to judge the success of theintroduction of nationwide referencepricing in Germany, since (1) results arenot unambiguous, (2) the number ofprescribed medical aids switches betweenproducts within a group, and actual pricesare currently impossible to disentangle andtherefore (3) it is not possible toadequately assess the impact on issues suchas patients’ equity of access, appropri-ateness and quality of care and the level ofinnovation of the industry. We thereforeconcentrate on expenditure per capita data.
With the exception of incontinenceproducts, expenditure per capita decreasedfor all categories of medical aid with areference price. The greatest fall in expen-diture was observed in those categories ofmedical aid that had rarely made prior useof reference pricing. In the case of hearingaids, where reference pricing had existedbefore 2005, only a small decrease inexpenditures could be observed.
Compared with all non reference-pricecategories, which increased after 2004, it isstriking that expenditures for categoriesgrouped using reference prices decreased
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Figure 1: Expenditures per insured per year (with expenditures of 2004 as the index year)
Source: Calculations, based on data of GEK Heil- und Hilfsmittelreport 2004–2007.2–5
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within two years to 91% of their 2004expenditure levels. Nevertheless, thesedecreases are much less pronounced thanthose seen after the introduction ofreference prices for pharmaceuticals.1,9
It should however be noted that thedemand for medical aids is influenced bymany other factors that are difficult tocontrol. Price elasticities for co-paymentsmay vary between categories and thus maycause expenditure change. Distribution ofmarket power may also influence the levelsat which reference prices are set. In cate-gories where manufacturers have strongmarket power, the reference price could beset rather high, whilst in other categoriesthe strong influence of the sickness fundsmay lead to markedly low prices and thusto lower expenditures. Moreover, we havenot been able to incorporate epidemio-logical factors, such as change in theincidence of disease associated with certainmedical aids, into this analysis.
Looking at our results from a macrosystem-perspective, one overall conclusionat this stage is that while the reference pricesystem has contained expenditure withinthe SHI system, it cannot automatically beequated to increased efficiency as thiswould require more detailed analysis of theprecise changes in product price and use.Even if such data were to become available,careful analysis of the impacts on popu-lation health, appropriateness and equityof care, as well as efficiency, would requiremore of the types of data that arecommonly used within the health techno-logical assessment of pharmaceuticals.
It may be that because of these difficulties,Germany is already experimenting in newways of organising both access to andfinancing of medical aids, such as through
public tenders. Under this policy, intro-duced in 2007, sickness funds are requiredto use public procurement procedures.They invite tenders from distributors (notmanufacturers unlike the situation forpharmaceuticals) for providing certainmedical aids to their insured populations ina specified area. Taking a closer look at theresults of this new instrument will be wellmerited as soon as they become available.
REFERENCES
1. Busse R, Schreyögg J, Henke KD. Regu-lation of pharmaceutical markets inGermany: improving efficiency andcontrolling expenditures? InternationalJournal of Health Planning andManagement 2005;20:329–49.
2. Scharnetzky E, Deitermann B, Michel C,Glaeske G. GEK-Heil- und Hilfsmittel-Report 2004: Auswertungsergebnisse derGEK-Heil- und Hilfsmitteldaten aus demJahre 2003 [GEK remedies and aids report2004: Outcomes of data evaluation from2003]. Sankt Augustin: Asgard-Verlag,2004. Available at http://media.gek.de/downloads/magazine/Edition31-Heilmittel_Report_ 04.pdf
3. Scharnetzky E, Deitermann B, HoffmanF, Glaeske G. GEK-Heil- und Hilfsmittel-Report 2005: Auswertungsergebnisse derGEK-Heil- und Hilfsmitteldaten aus demJahre 2003 und 2004 [GEK remedies andaids report 2005: Outcomes of dataevaluation from 2003 and 2004]. SanktAugustin: Asgard-Verlag, 2005. Availableat https://www.gek. de/x-medien/dateien/magazine/Heil_und_Hilfsmittel_Report_2005.pdf
4. Deitermann B, Kemper C, Hoffmann F,Glaeske G. GEK-Heil- und Hilfsmittel-Report 2005: Auswertungsergebnisse derGEK-Heil- und Hilfsmitteldaten aus dem
Jahre 2004 und 2005 [GEK remedies andaids report 2005: Outcomes of data evalu-ation from 2004 and 2005]. Sankt Augustin:Asgard-Verlag, 2005. Available athttp://media.gek.de/downloads/magazine/Heil-und-Hilfsmittel-Report-2006.pdf
5. Deitermann B, Kemper C, Glaeske G.GEK-Heil- und Hilfsmittel-Report 2007:Auswertungsergebnisse der GEK-Heil- undHilfsmitteldaten aus dem Jahre 2005 und2006. [GEK remedies and aids report 2007:Outcomes of data evaluation from 2005and 2006]. Sankt Augustin: Asgard-Verlag,2005. Available at http://media.gek.de/downloads/magazine/Heil-und-Hilfsmittel-Report-2007.pdf
6. Nahnhauer A, Kaesbach W. Reim-bursement of medical devices in Germany.Health Economics in Prevention and Care2000;1:140–45.
7. Brose B, Felder S. 2006. Stärkung desVertragswettbewerbs? Die gesetzlichenRegelungen bei den Hilfsmitteln auf demPrüfstand. [Strengthening the contract-competition? The statutory regulations formedical devices put to test]. Essen: BKKBundesverband, 2006. Available athttp://www.bkk.de/bkk/powerslave,id,1026,nodeid,.html
8. Deutsche Krankenhaus Gesellschaft.Gutachten 2005 des Sachverständigenrateszur Begutachtung der Entwicklung imGesundheitswesen [Report 2005,Coordination and Quality in the HealthCare System]. Berlin: 2005. Available athttp://www.dkgev.de/dkg.php/cat/35/aid/2711/title/Gutachten_2005_des_Sachverstaendigenrates_zur_Begutachtung_der_Entwicklung_im_Gesundheitswesen
9. IKK Bundesverband. Übersicht überFestbetragsgruppen für Hilfsmittel vor 2005[Summary of Reference Price Groups forMedical Devices before 2005].Unpublished document.
Table 1: Overview of changes in expenditure for different categories of medical aids
Category Expenditure per insuredindividual 2004 (€)
% of total expenditure formedical aids per insured
individual 2004
Reference pricesin X of 16 Länder
in 2004
Expendituredevelopment in 2005
(index year 2004)
Expendituredevelopment in 2006
(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.
Eurohealth Vol 14 No 3 12
PUBLIC HEALTH PERSPECTIVES
IntroductionCancer has been known and researchedsince antiquity, but substantial progress incancer control has only been made in thelast few decades. Greater understanding ofthe causes of cancer has had a major impacton both primary and secondary preventionof cancer, as well as on treatment andrehabilitation. In terms of reducing humanexposure to cancer risk factors, one of themost important discoveries of the twen-tieth century was the role of tobaccosmoking as a cause of cancers of the lungand various other organs.1 The outcome ofanti-smoking measures is now becomingvisible. Lung cancer incidence and deathrates among men are decreasing steadilywhere they have been effectively imple-mented, such as in western and northernEuropean countries.2
A more recent achievement in primaryprevention is the identification of theHuman Papilloma Virus (HPV) as thecause of cervical cancer, and the devel-opment of vaccines against carcinogenictypes of HPV; some vaccines were licensedin 2006 in the European Union.
Secondary prevention, and specificallyearly diagnosis of breast and cervicalcancers through organised mass-screeningprogrammes, has led to a reduction incancer mortality and an overallimprovement of the quality of life ofcancer patients. A more recent oppor-tunity for cancer control is faecal occultblood testing, which has been shown toreduce mortality from colorectal cancer.3
Although pharmacological treatment isresponsible for a small proportion of curesin patients with cancer overall, its contri-bution in tackling some types of cancer(testicular and breast cancer, leukaemia andHodgkin’s disease) has led to an impressiveincrease in survival from these cancers anda significant reduction in the number ofdeaths.4 All these developments, along withmajor innovations in imaging, surgery, andradiotherapy, have radically changed theperception and management of cancer.Some cancers can now be cured, whileothers are increasingly seen as a ‘chronic’condition rather than a fatal disease, whichmeans that a patient is more likely to diewith a cancer, rather than of it. Advances ingenetics and in genetic epidemiology and
the Human Genome Project(http://www.genome.gov) now offer newperspectives for diagnosis, treatment, andsoon maybe prevention, of many diseases,including cancer.
Life expectancy has increased dramatically.A century ago, life expectancy in Europewas less than forty-five years and the maincauses of death were infectious diseasesand diseases related to poor nutrition. Thecontrol of infant mortality in westerncountries produced the first significantgains in life expectancy; then, the intro-duction of penicillin, sulfa drugs and strep-tomycin yielded another significantreduction, this time in adult mortality.From the 1960s onwards, an increasingarray of drugs has made it possible tocontrol a growing number of chronicconditions, such as hypertension andasthma. The result has been a downwardtrend in morbidity and disability.5
However, these impressive gains havecoincided with, and indirectly contributedto, an increase in the burden of diseaseattributable to cancer. In the WHOEuropean Region, only 5% of cancerdeaths occur in people less than forty-fiveyears of age. The majority of deaths fromcancer occur after this age, three-quartersof which are in people aged sixty years andolder.6 The inevitable consequence ofageing and population growth in Europehas been a very large increase in the burdenof cancer.
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 ahuge problem in Europe, in terms of both morbidity and mortality. Thisarticle summarises the challenges posed by cancer in Europe today andthe measures available to tackle them. It is based on ‘Responding to theChallenge of Cancer in Europe’, a collaboration between internationallyrecognised public health institutes in the European Union, under theumbrella Fighting Against Cancer Today (FACT).
Keywords: Cancer, Cancer Control, Inequalities, Prevention, Policy
Delia-Marina Alexe is Clinical ResearchFellow,
Michel Coleman is Professor of Epidemi-ology and Vital Statistics, Non-Communi-cable Disease Epidemiology Unit, and
Martin McKee is Professor of EuropeanPublic Health, Health Services ResearchUnit, all at the London School of Hygieneand Tropical Medicine, London, UnitedKingdom.
Tit Albrecht is Researcher in HealthServices at the Institute of Public Health,Ljubljana, Slovenia.
For these reasons, in spite of the advancesin cancer control, cancer remains a hugeproblem in Europe, in terms of bothmorbidity and mortality. This articlesummarises the challenges posed by cancerin Europe today and the measures designedto tackle them. It is based on ‘Respondingto the Challenge of Cancer in Europe’, acollaboration between internationallyrecognised public health institutes in theEuropean Union, under the umbrellaFighting Against Cancer Today (FACT).*FACT is co-funded by the Government ofSlovenia and the European Commission’sHealth and Consumer Protection Direc-torate. Participating institutions include theNational Institute of Public Health ofSlovenia as the co-ordinators, the LondonSchool of Hygiene and Tropical Medicine,the Institute of Oncology in Ljubljana andthe European Observatory on HealthSystems and Policies.
Cancer: current challenges and cancercontrol
The burden of cancer
Worldwide, about ten million people arediagnosed with cancer each year. A sharpincrease of 50% in the incidence of cancerhas been predicted by 2020, mainly due toageing populations in both developing anddeveloped countries, but also as a result ofcurrent trends in smoking prevalence andthe growing adoption of unhealthylifestyles.7 One-third of the global burdenof cancer is recorded in Europe: in 2006,there were 3.2 million new cases of cancerand about 1.7 million cancer deaths. In the25 EU Member States (EU25 – pre-2007),one out of four deaths was attributed tocancer. Most cases and most cancer deathsare due to four common cancers, those ofbreast, prostate, lung and large bowel.8
The number of new cases and cancerdeaths in Europe has increased and is likelyto rise further. The accompanyingimprovement in survival has led to an evengreater increase in prevalence. Projectionsof future cancer incidence indicate thateven if the risk of getting cancer at each agedoes not change, the number of new cancerpatients diagnosed each year in the pre-2007 EU25 Member States will rise by20% in the eighteen years between 2002and 2020, simply due to populationgrowth and ageing. Incidence rates wouldhave to fall by more than 1% every yearover that period in order to counterbalance
the upward pressure of these demographicchanges on the numbers of new patientsthat health systems will have to manage.2
Cancer patients will be older than today,and many will have several co-existingillnesses, so the health needs of cancerpatients will become even more complex.This upward demographic pressure on thecancer burden is one of the biggestchallenges in cancer control.
Implementation of effective strategies forcancer control is essential to counteractthese trends. These measures must includeprimary, secondary and tertiaryprevention. In particular, measures areneeded to tackle tobacco smoking, themost preventable cause of cancer; topromote mass (population-based)screening programmes for cancers of thecervix, breast and large bowel (colon andrectum), and to extend the adoption andaccessibility of effective treatments to allpatients within an ‘integrated care’ system.Lastly, adequate provision for greaternumbers of cancers among older people isessential.
Inequalities in cancer in Europe
Europe has some of the richest countriesin the world, but also some of the poorest.In 2002, 168 million people were livingbelow the poverty line, about 46% of theEuropean population.9 These socio-economic differences are reflected insignificant health gaps not only betweenand within the countries of the Europeanregion, including the European Union.They are seen in both the burden of cancerand the range of survival. Differences inthe burden of cancer result mainly frominternational differences in exposure tocancer risk factors (for example, prevalenceof smoking, unhealthy diet, obesity) andsocioeconomic characteristics; however,they are also an indicator of the overalldelivery of services for the prevention andtreatment of cancer, including organisedscreening programmes, the existence andaccessibility of health care facilities andtechnological infrastructure, and the avail-ability of human, financial and materialresources for health and economic devel-opment. A survey by the EuropeanSociety of Clinical Oncology, designed toassess the status of medical oncology inEurope (MOSES, Medical OncologyStatus in Europe Survey, www.esmo.org/resources/surveys/mosesII_survey/?get_resource=241), has found significantdiscrepancies in the provision of cancercare throughout Europe, including accessto surgery, radiotherapy and cancer drugs.
Progress in cancer control can be seen inmost countries, but in some, cancer controlis still in its infancy. Efforts to tackle cancerin northern and western European coun-tries during recent decades have resulted indecreasing mortality and increasingsurvival from those cancers that areamenable to either primary or secondaryprevention (for example, lung cancer,breast and cervical cancers). By contrast, insome countries that have joined the EUsince 2004, the lack of financial and humanresources, along with uncoordinatedefforts in the organisation of cancercontrol, has been associated with anincrease in mortality and a poor prognosisfor cancers that could have been prevented,or detected in an early phase. Furthermore,at the population level, a lack of cancerawareness in central and eastern Europeancountries has been described, especially inregard to prevention as a means of cancercontrol.10
A dramatic contrast in mortality fromcervical cancer has been described betweenEUMember States in western Europe andthose in central and eastern Europe. Deathfrom cervical cancer is now relativelyuncommon in western European coun-tries, but in Latvia, Bulgaria, Lithuania andRomania there is a continuing increase incervical cancer mortality. In Romania,mortality from cervical cancer has reachedlevels that have never been seen before inEurope.10 In the late 1990s, there was agreater than tenfold difference between thehighest cervical cancer death rate, inRomania, with no organised mass-screening programme, and the lowestdeath rates in Finland and Sweden, wherepopulation coverage of cervical cancerscreening is almost 100%.11 The treatmentenvironment for cancer patients is alsoextremely difficult in Romania, as theconcept of integrated care is non-existent.Another dire example is that of Estonia,where population-based medical registriesand epidemiological research are still seri-ously hampered by data protection legis-lation that omits any of the exemptionsprovided under the EU Directive for theprocessing of personal data for historical,statistical or scientific purposes. This hascompletely disabled surveillance of trendsin cancer incidence and survival.12
Health inequalities between ‘old’ (pre2004) and the twelve ‘new’ EU MemberStates merit particular attention from boththe health authorities of the countriesconcerned and the EU as a whole. Cancercontrol must be a priority for the
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* website http://www.projectfact.eu
European Commission, both now and infuture action plans. There is a particularneed to support the most severely affectedMember States, and scope for this isoffered by the Commission’s StructuralFunds. Exchange of best practices incancer control across the EU, backed upby substantial funding in countries wherethe health care system is in ‘transition’ andcancer control measures are under devel-opment, could also substantially reducethese inequalities in cancer outcomes.
Within countries, adequate political andfinancial support is needed to enable thecreation and operation of population-based screening programmes and cancerregistries. This should include an appro-priate legislative framework and stablelong-term funding. National educationprogrammes should be implemented tochange attitudes towards cancer and cancerprevention, building upon initiatives suchas the European Code Against Cancer.
Key risk factors for cancer and preventionpolicies
Some lifestyle factors, such as tobaccosmoking, alcohol consumption, unhealthydiets and lack of physical exercise, orexcessive exposure to sun, play animportant role in the causation of cancer.The biggest challenge in primaryprevention remains tobacco smoking,linked to between 80–90% of lung cancersand between 40–60% of cancers of theoesophagus, larynx and oral cavity.13
Despite the significant impact of anti-smoking interventions implemented insome countries since the early 1980s, lungcancer is still the leading cause of cancerdeath in Europe. Importantly, althoughlung cancer rates in males have stabilisedor have been decreasing in northern andwestern European countries, lung cancermortality among women is still rising inmany European countries, in particular insouthern and eastern European countries.2
While some European countries havemade impressive progress in tobaccocontrol, others still have much to do. It isremarkable that many countries still allowsmoking in public places.
Another challenge in cancer prevention isthe excessive consumption of alcohol,twice as high in Europe as the worldaverage. Alcohol is a cause of severalcancers, such as those of the upperdigestive and respiratory tract, andprimary liver cancer.13.14 When alcoholconsumption is combined with tobaccosmoking, cancer risk increases exponen-
tially.14 Although the role of diet in cancercausation is still relatively under-explored,it has been estimated that about one-thirdof all cancer mortality may be related tounhealthy diets,15 while a diet low in freshfruit and vegetables seems to increase therisk of cancer in those exposed to othercarcinogens.16 There is also evidencesupporting the role of obesity as a cause ofsome cancers.13,14 Preventing skin cancerremains equally important, because theincidence of melanoma of the skin inEurope has doubled since the 1960s.
Viruses such as HPV and the hepatitis Band C viruses cause more than 20% ofcancers in developing countries but onlyabout 8% of all malignancies in developedcountries.7 This gap is also apparent inEurope, where cervical cancer is a majorproblem in central and eastern Europeancountries.10
A broad policy framework is needed forcancer control in Europe. Policy will needto harness some essential tools for theprevention of tobacco smoking andalcohol consumption, such as the WHOFramework Convention on TobaccoControl and the Framework for AlcoholPolicy in the WHO European Region.Effective strategies to reduce tobacco andalcohol consumption include pricingpolicies, policies to reduce the harm causedby exposure to environmental tobaccosmoke and harmful drinking of alcohol,policies to reduce demand and limit access(in particular the locations and times whenalcohol can be purchased), and by theavoidance of internal market policies thatpromote consumption.13,17 Unfortunately,both the tobacco and alcohol industrieshave been successful in preventing effectiveaction in many countries, often promotingcampaigns to undermine the evidenceabout effective health policies.
Another tool is the European CodeAgainst Cancer, an integrated instrumentfor cancer prevention. It focuses onpromoting the adoption by individuals ofhealthy lifestyles, including participationin screening programmes.14 It provides animportant basis for health promotion byhealth care professionals and non-govern-mental organisations.
Most countries in Europe have seen a rapidincrease in the prevalence of obesity inrecent years: tackling this epidemic shouldbecome a priority in the EU.13 The GlobalStrategy on Diet and Physical Activityprovides a solid basis for action.Promoting physical activity would help in
reducing average body weight, but it hasalso been linked to a reduction in the riskof cancers of the breast, body of the uterusand prostate, independently of weightcontrol.14
Interventions to tackle cervical cancershould be tailored to the particular situ-ation of each country. For example, HPVvaccination would provide a new approachto preventing cervical cancer, particularlyin countries with a high incidence of thedisease and inadequate screening.18 Toprevent infection with hepatitis B virus inEurope, systematic vaccination is neededas a part of national immunisationprogrammes. No vaccine is yet available toprevent infection with hepatitis C virus.
Costs of diagnostic and treatment services
Early diagnosis and optimal treatment ofcancer is complex. It requires education,prevention, diagnosis, treatment andpalliative care. One of the most importantchallenges in cancer control is to coor-dinate national plans and services to coverall aspects of the management of cancer.
During the last decade, the diagnosis andtreatment of cancer have become increas-ingly expensive, as a result of rapidadvances in technology and drug devel-opment. Pressure from the pharmaceuticalindustry has led to the prioritisation ofdrugs over other treatment modalities. Theoncology drug market is expected to growsteadily as a result of the ageing popu-lation, the development of new treatmentsand advances in cancer genetics. Develop-ments in molecular pathology, imaging,radiotherapy and surgery are at least asimportant in the management of cancer,and should also be strongly encouraged bythe EU, along with long-term investmentin the training of staff and the acquisitionand/or renewal of equipment.17
New and expensive drugs that offer nosubstantial advantage over existing treat-ments are being promoted. This places afurther burden on national health services,insurers and cancer patients. For example,one cycle of temozolomide, used intreating some brain tumours, is 350 timesmore expensive than the reference drugprocarbazine, although these two arelargely equivalent in terms of efficacy andsafety.4
The increase in the cost of cancer care, andin the cost of drugs in particular, is likely toprevent equal access to optimal care to allpatients in an economically limited system,with different countries choosing different
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thresholds to trigger the availability ofdrugs for defined groups of patients.19 Arecent example from England concerns theproposal by the National Institute forHealth and Clinical Excellence (NICE) forthe ‘rationalisation’ of chemotherapeutictreatment for kidney cancer with fourtypes of drugs, based on their lack of cost-effectiveness for treating patients withadvanced or metastatic renal cellcarcinoma.20
Health care policy-makers and fundersneed to examine the cost-effectiveness ofnew technologies as closely as the efficacyof the drugs themselves. National govern-ments have a responsibility to establishmechanisms to ensure that clinicallyproven interventions that maximise boththe duration and quality of life areavailable to all their constituents. Robusthealth technology assessment is essential,followed by equity in the distribution oftreatment resources.19
Cancer control: an integrated approachIt has been estimated that a quarter ofcancers could be prevented by applyingexisting knowledge, while a further thirdof cancers may be curable using currenttreatments and technologies.7 For fatalcancers, palliative care is an essentialcomponent of cancer care. It is aimed bothat improving the quality of care for cancerpatients and their families, and at helpingthem both to live well until they die, andto die well.21 An integrated strategy forcancer control must thus include allelements of prevention, as well astreatment, palliative care and research.
At a national level, a key requirement forsuccessful cancer control is the devel-opment of a coordinated cancer plan.WHOpublished six guides as a frameworkfor a comprehensive planned approach tocancer control. These can be used toidentify priorities for action and researchacross the entire spectrum of cancercontrol. Implementation of these activitiesneeds to be monitored constantly,alongside the overall efficacy of the healthsystem, one indicator of which is cancersurvival. Cancer information systems suchas screening registries and cancer registriesare essential tools; their operation requiresadequate investment and legal protection.
At the EU level, measures to complementnational policies in Member States areneeded. For example, the 1995 EU dataprotection directive has impeded theeffective operation of cancer registries. TheDirective must be revised to enable and
protect cancer registration.17 Reducinghealth inequalities across the EU shouldalso be a priority: more support andinvestment are needed in the most affectedMember States. Measures to control theeffects of unhealthy lifestyles have animportant potential to supplement healthcare provisions everywhere. These includestrategies to tackle tobacco smoking andalcohol consumption, and those whichpromote healthy nutrition and physicalactivity, safe occupational and environ-mental guidelines, as well as the preventionof infections that cause cancer.
REFERENCES
1. Doll R, Peto R. Mortality in relation tosmoking: 20 years’ observations on maleBritish doctors. British Medical Journal1976;2:1525–36.
2. Bray F. The burden of cancer in Europe.In: Coleman MP, Alexe DM, Albreht T,McKee M (eds). Responding to theChallenge of Cancer in Europe. Ljubljana:Institute of Public Health of the Republicof Slovenia, 2008:7–39.
3. Hakama M, Coleman MP, Alexe DM,Auvinen A. Cancer screening. In: ColemanMP, Alexe DM, Albreht T, McKee M (eds).Responding to the Challenge of Cancer inEurope. Ljubljana: Institute of PublicHealth of the Republic of Slovenia,2008:69–92.
4. Garattini S, Bertele V. Efficacy, safety,and cost of new anticancer drugs. BMJ2002;325:269–71.
5. Anonymous. The future of human lifeexpectancy: have we reached the ceiling oris the sky the limit? Research Highlights inthe Demography and Economics of Aging2006;8:1–4.
6. World Health Organization. RevisedGlobal Burden of Disease (GBD) 2002Estimates. Geneva: World HealthOrganization, 2004.
7. World Cancer Report. Lyon: WHOInternational Agency for Research onCancer, IARC Press; 2003.
8. Ferlay J, Autier P, Boniol M, Heanue M,Colombet M, Boyle P. Estimates of thecancer incidence and mortality in Europein 2006. Ann Oncol. 2007;18:581–92.
9. WHO Regional Office for Europe. TheEuropean Health Report. 2002. Copen-hagen: WHO Regional Publications,European Series, No. 97.
10. Zatonski W, Didkowska J. Closing thegap: cancer in central and eastern Europe.In: Coleman MP, Alexe DM, Albreht T,McKee M (eds). Responding to the
Challenge of Cancer in Europe. Ljubljana:Institute of Public Health of the Republicof Slovenia, 2008:253–78.
11. Levi F, Lucchini F, Negri E et al.Cervical cancer mortality in young womenin Europe: patterns and trends. Eur JCancer 2000;36:2266–71.
12. Rahu M, McKee M. Epidemiologicalresearch labelled as a violation of privacy:the case of Estonia. Int J Epidemiol.2008;37:678–82.
13. Martin-Moreno JMM, Magnusson G.The causes of cancer and policies forprevention. In: Coleman MP, Alexe DM,Albreht T, McKee M (eds). Responding tothe Challenge of Cancer in Europe.Ljubljana: Institute of Public Health of theRepublic of Slovenia, 2008:41–68.
14. Boyle P, Autier P, Bartelink H et al.European Code Against Cancer andscientific justification: third version (2003).Ann Oncol. 2003;14:973–1005.
15. Divisi D, Di TS, Salvemini S,Garramone M, Crisci R. Diet and cancer.Acta Biomed. 2006;77:118–23.
16. Lock K, Pomerleau J, Causer L, McKeeM. Low fruit and vegetable consumption.In: Ezzati M, Lopez AD, Rodgers A,Murray CJL (eds). ComparativeQuantification of Health Risks: Global andRegional Burden of Disease Due to SelectedMajor Risk Factors. Geneva: WHO;2004:597–728.
17. Albreht T, McKee M, Alexe DM,Coleman MP, Martin-Moreno JM. Makingprogress against cancer. In: Coleman MP,Alexe DM, Albreht T, McKee M (eds).Responding to the Challenge of Cancer inEurope. Ljubljana: Institute of PublicHealth of the Republic of Slovenia,2008:315–27.
19. Sikora K. Drugs for cancer. In:Coleman MP, Alexe DM, Albreht T,McKee M (eds). Responding to theChallenge of Cancer in Europe. Ljubljana:Institute of Public Health of the Republicof Slovenia, 2008:93–112.
20. O’Dowd A. Watchdog set to reject fourdrugs for kidney cancer on the NHS. BMJ2008;337:1262.
21. Higginson I, Costantini M. Dying withcancer, living well with advanced cancer.In: Coleman MP, Alexe DM, Albreht T,McKee M (eds). Responding to theChallenge of Cancer in Europe. Ljubljana:Institute of Public Health of the Republicof Slovenia; 2008:231–52.
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In 2008, the European Commissioninitiated infringement proceedings againstGermany over its restrictions on theownership of pharmacies. Similar actionshave been undertaken against the regu-lation of pharmacies in Spain, France,Austria and Italy. These infringementprocedures concern a series of restrictionsrelating to the opening and running ofpharmacies including: the incompatibilitybetween the distribution and retail sale ofpharmaceutical products; having theownership of pharmacies reserved exclu-sively for pharmacists; territorial anddemographic limits in the setting-up ofpharmacies; and a ban on owning morethan one pharmacy.
The distribution and dispensation of drugsis a highly regulated activity in most of the
EU15; however, the pace of these regula-tions has not kept up to speed with devel-opments in the sector. Since themid-twentieth century, the activities of thecommunity pharmacy have altered consid-erably. Pharmacists, who originallyoperated as drug producers, have nowmoved towards activities related to thedistribution of manufactured products thatare already scrupulously labelled by thepharmaceutical industry. These productsare delivered directly to the pharmacythrough the wide-reaching logistics ofwholesale distributors, who centralisepurchasing and deliver to individualpharmacies up to five times a day. It isthese intermediaries who provide themajority of the value associated with thedrug distribution system, since theyguarantee pharmaceutical supply andaccessibility. Because pharmacies no longerneed to hold substantial stocks, they can
save money that would otherwise be tiedup in inventory.
Wholesalers perform two broad functionsin the supply chain of the pharmaceuticalindustry: (i) they provide basic logisticfunctions for pharmaceutical distribution,bridging distances and time, while assuringquality and quantity, and (ii) they provideservices that may add value to both phar-maceutical manufacturers and retailers,including sales analyses, marketing assis-tance and product training, specialhandling services and product recalls.1
However, this major shift in the responsi-bilities and duties of the different playersin the sector has hardly been reflected inthe design of new governance regulations.Regulations, thus, have become outdatedand no longer correspond to the currentparameters of a sector which has changedsubstantially since the laws to regulate itwere originally put in place.
Lampedusa and pharmaceuticaldistribution: communitypharmacy in the 21st century
Ricard Meneu
Summary: Within the context of the countries belonging to the EU beforeMay 2004 (EU15), regulation of the pharmaceutical industry is currentlyunder close scrutiny. Attempts at reform often attract the attention of variousstakeholders and European institutions, who may flag up violations ofEuropean Community norms in Member State legislation. Although much ofthe debate revolves around business issues (i.e., property, planning, mergersand acquisitions) there is a real need to redefine the professional activities ofpharmacy personnel whose roles have changed radically over recent decades.
Key words: Community Pharmacy, Regulation, Profession, Incentives,Public Health
Ricard Meneu is based at the FundaciónInstituto de Investigación en Servicios deSalud, Valencia, Spain and the ResearchCentre on Health and Economics(CRES), Universitat Pompeu Fabra,Barcelona, Spain.Email: [email protected]
“If we want things to stay as they are, things will have to change”from The Leopard, Giuseppe Tomasi di Lampedusa (1958).
This study was supported by an unrestricted grant from the Merck Company Foundation,Whitehouse Station, New Jersey, USA, to CRES, Universitat Pompeu Fabra, Barcelona.
The views expressed are those of the author alone.
The regulation of drug distribution anddispensation has become a battle groundwith each player vying to draw the regu-lator to his own corner, and boost his shareof the pie. However, the whole process hasprogressively neglected to provide anyadded value to population healthimprovement.
One analysis of the major features ofpharmacy regulation reveals that, as aprofessional collective, the EuropeanCommunity’s pharmacists have managedto maintain a long-standing monopolyover the supply of drugs, both prescriptionand over-the-counter products, and tocontrol the number and location of phar-macies, while limiting the right toownership of these establishments.2 It ismore difficult to explain the frequentalignment of health care authorities withthe pharmacists’ interests. Some wouldargue that such regulatory capture is,overall, against the interests of society as awhole.
The laws governing pharmaceutical distri-bution have been reiteratively examined inEuropean countries to verify the ‘rentseeking’ hypothesis. Results coincide inshowing that, for the most part, legislationis oriented towards restricting the entry ofplayers, or limiting competition betweenexisting players, thus reinforcing the pre-eminence of private interests at the expenseof the public good.3
As a result of these tensions, in most of theEU15 countries, regulatory aspects ofdebatable efficiency are continuouslybeing challenged. Particular attention ispaid to the four ‘Big Ps’ – property(ownership), planning, payment andprofessional services. Regulationsgoverning property translate into theaccepted monopoly whereby only phar-macists can own pharmacies. They involvethe control mechanisms on access toownership and restrict its scope. Added tothis is the questionable congruence ofreserving for these establishments amonopoly on sales of all drugs, includingthose that do not require a medicalprescription.
There are limitations on the number ofpharmacies that may be opened in keepingwith planning criteria related to demo-graphic or geographic features that wouldguarantee accessibility. Reimbursement orpayment systems, with various fees,constant margins, capped margins andrebates may be questioned. Though theobject of less heated debate (although
central to the problem), are the professionalactivities conducted in pharmacies. It isprecisely these activities that justify arequirement for certain technical qualifica-tions to dispense what are none other thanmanufactured, pre-labelled products. Theseissues are now discussed in more depth.
PropertyAccess to ownership of pharmacies variesthroughout Europe, although in ten of theEU15 countries, it is limited to qualifiedpharmacists. This restriction, together withanother that limits the number of phar-macies that one proprietor can own, canmake it difficult to develop strategies thatwould have a favourable impact on effi-ciency, such as certain types of horizontalintegration to obtain economies of scale orscope or other (cost) advantages.2
Most Member States allow horizontalcooperation. Both partnerships with otherpharmacies and integration with druggistsare allowed in a majority of cases. Verticalintegration is restricted. Seven MemberStates allow pharmacists and wholesalersto integrate; while only six Member Statesallow integration between pharmacists andproducers. Countries with no chains ofpharmacies include Denmark, Spain,France, Germany and Austria.2,4
Prohibiting non-pharmacists or legalentities not consisting of pharmacists fromhaving holdings in pharmacies goesbeyond what is necessary to achieve theobjective of public health protection, sinceit would be sufficient to require thepresence of a pharmacist to dispense medi-cines to patients and to manage stocks.Since compliance with professional stan-dards is guaranteed independently of thepresence of the owner on the premises,requiring owners to be qualified pharma-cists is a redundant measure.
The champions of this model, i.e. currentowners and their professional ‘guilds’claim that “rules on the ownership areestablished by national legislation to guar-antee the independence of the profession,to ensure that decisions are not takensolely for commercial reasons and to guar-antee the provision of high qualitypharmacy services”.5 This, however itmight be argued, fools no one, as it isunlikely that a businessman’s professionalqualifications will lead him to act againsthis own interests. On the contrary, profes-sional qualifications can supply the ownerwith the knowledge and skills necessary toimplement practices just this side of whatis acceptable.
Furthermore, if “pharmacists must beindependent frommajor market entities orother parties that might influence profes-sional decisions”5 it does not seemreasonable that in some countries it ispharmacists who are the owners of mostdistribution companies, established underthe format of ‘cooperatives’. This type ofbottom-up vertical integration leaves themopen to the same risks of “commercialpressures” as the opposite, prohibited, top-down integration under which wholesalerscan, in turn, be owners of pharmacies.
Under scrutiny, limiting ownership ofpharmacies to qualified pharmacists is notjustified in operational terms. It clasheswith both the regulation of some nationalmarkets and rules governing other healthcare establishments. Even in the case ofcomplex organisations providing healthcare services (for example, specialisedhospitals) there are no similar ruleslimiting ownership to specific profes-sionals, as there are no limitations onshareholder composition.
PlanningIn order to ensure that pharmacy servicesand medicines are conveniently accessibleto all citizens and to avoid the situationwhere pharmacies are concentrated inhighly populated urban areas, severalMember States have criteria on the estab-lishment of new pharmacies.
Seven of the EU15 countries studied setrequirements on their location. The mostcommon restrictions are related to aminimum number of potential customersand a minimum distance between phar-macies. In general, these planningmeasures translate into relatively simplerules that may be based on arbitraryfigures which leave a wide berth for discre-tionary decisions.
A reasonable distrust of the efficiency ofthese mechanisms is reflected in some ofthe ‘infringement proceedings’, thatindicate that some of the measures adopteddo not in fact achieve their intended objec-tives. They can be counterproductive tothe goals of ensuring a good supply ofmedicines across a country.
Another concern is that these mechanismsmay lead to the creation of artificiallyprotected monopolies which then usecross subsidies to support activities that arenot profitable. Alternative solutions havebeen proposed, such as the establishmentof transparent subsidies to pharmacies,provided on the basis of sound public
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interest objectives, in situations whereactivities could not be performed on aprofitable commercial basis.4 Versatiledistribution systems are needed to helpensure access for both people living inremote rural areas and those whomay findit difficult to travel to a pharmacy. Oneoption, to date under-exploited because oflegal restrictions in many EU-15 countries,could involve dispensing drugs over theinternet.
“To define the objectivesessential to a 21st centurycommunity pharmaceuticalsector, it is necessary to promotethe interests of demand overthose of supply. This willrequire redesign of regulationand incentive systems”
PaymentPayment systems provide an efficient wayto orient any sector’s agents towards aspecific role, and pharmaceutical distri-bution is no exception. Depending on thesystem adopted, a pharmacy’s income islinked to a greater or lesser extent to theprice and number of products dispensed,or the professional services it provides.There are three basic financing categories:6
those that are product oriented, those thatare patient oriented, and those that are acombination of the two. While the lattertwo are similar to the payment schemesusually adopted to remunerate otherprofessional health care providers – fee forservice, capitation and salaries – ‘productoriented’ schemes are more similar to retailreimbursement models.
Pharmacists usually receive a fee related tothe number of transactions they conduct.More specifically, they receive a fixed feeand/or a percentage (fixed or variablemargin) of the drug price per dispensedprescription drug. The fixed fee issupposed to reimburse pharmacists fortheir provision of pharmaceutical services.However, the fact that this reimbursementis related to the number of prescriptionsrather than to the actual provision of phar-maceutical services has been criticised bysome authors.1
Systems based on the payment of marginsare undesirable in an environment wherethere is a wide variability in the pricing of
products that have similar costs in terms ofsupply, storage, conservation and dispen-sation. There is a clear need to redefine thecriteria for remuneration of pharmacies, asis stated in theResolution of the Council ofEurope ResAP (2001) 2 concerning thepharmacist’s role in the framework ofhealth security. This recommends that “thesystem under which (pharmacists) areremunerated must be reviewed to reflectthe professional service they provide ratherthan the profit margin or volume of theirsales, in accordance with Resolution AP(93) 1 on the role and training ofcommunity pharmacists”.7
Professional activitiesOther concerns less frequently addressed,although central to this discussion, relateto whether professional activities justifythe need for specific qualifications. Today,pharmacists largely dispense manufacturedproducts that are carefully labelled againsta prescription document, which generallyincludes specifications about the product,dosage, person for whom the product isintended, along with a justification of theindication.
Although “common medicinal products,such as paracetamol and aspirin, can bedangerous if they are not taken in appro-priate quantities and in the appropriateway”,5 this does not mean that everydispensing act requires professional adviceand counsel. When an individual patientbuys aspirin time and time again, it is notusually necessary for the pharmacist toremind him or her of the risk of stomachbleeding associated with its analgesic andcardio-protection properties. Currentlegislation obviously does not require theprovision of such services.
Any redefinition of the professional role ofpharmacists will necessarily incorporateclaims of the need to pay for ‘Pharmaceu-tical Care’ (PC), a concept that has notbeen clearly defined. So pending thedemonstration of the overall efficiency ofPC, the implementation of programmes toreview utilisation for the purpose of devel-oping schemes for professional devel-opment, while a difficult task, is one thatwill no doubt benefit all stakeholders. Theflashy promises of PC, a concept that hasnot even reached an embryonic stage, maybe making us forget the fact that the mereverification ex ante of therapeuticcompliance and avoiding certain interac-tions and counter indications wouldprovide substantial added value that iscurrently absent in the current situation.
ConclusionsThe discourse over the regulation of thepharmaceutical distribution sector invokespublic safety and consumer protection. Itgenerally masks the desire to preserve instatu quo and thus inhibit any devel-opment that may actually benefit the usersof distribution services over pharmacyowners.8 There is no doubt that publichealth must be guaranteed through thedistribution of drugs; however, in order todo this, clear objectives must be definedand mechanisms established to meet thegoals sought, followed by careful evalu-ation of their empirical efficiency. This isvery different from what is happeningtoday when out-dated strategies, designedfor a time when the activities of pharma-cists were very different, are beingpreserved.
The sector also invokes the nebulousnotion of ‘public health’, even though theeffects of the current system can includethe preservation of unfair monopolies thatonly enhance revenues for pharmacists, theevident capture of the regulator by theobjects of regulation and the maintenanceof unsuitable payment schemes. All of thiscan be set against the absence of a cleardefinition of both the desirable profes-sional services to be rendered and theircontribution to population healthimprovement.
Any analysis of current regulation mustclarify whether current laws promote orinhibit efficiency in the sector, and whetherthey translate into real benefits forconsumers instead of acting as a mech-anism to hike up prices unnecessarily. Anadequate evaluation of sector regulationwould require, on the one hand, a countryby country comparison, accompanied,above all, by an exhaustive analysis of thetensions that exist between the pharmacy,a venue that not only retails drugs, but thatshould also provide professional services,and all of the other stakeholders partici-pating in the drug-provision cycle.
To define the objectives essential to atwenty-first century community pharma-ceutical sector, it is necessary to promotethe interests of demand over those ofsupply. This will require redesign of regu-lation and incentive systems, in an effort toalign the interests of (i) professional phar-macists, as providers of valid specialisedservices and not only as mere drugretailers, (ii) the health care system inwhich this sector has been integrated untilnow in an anomalous position and iii) thepublic which it supposedly serves. Any
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In most of the world, access to and supplyof medicines is governed by a regulatoryframework which is based on perceptionsof the risks and benefits of the medicine tothe population. In the UK, for example,there are three broad categories of medi-cines: POM (prescription only medicines),P (pharmacy supervised sale), and GSL(general sales list).
POM medicines are primarily onlyavailable to the public when prescribed bya medical practitioner, although histori-cally dentists have long been able to supplyfrom a limited Dental Formulary. Morerecently in the UK, full prescribing rightshave also been accorded to other healthcare professionals such as nurses and phar-macists, as long as certain specified condi-tions are met. P medicines can only be soldunder the supervision of a pharmacist frompremises registered with the Royal Phar-maceutical Society of Great Britain(RPSGB), and GSLmedicines are availablefrom any retail outlet. When moving fromPOM through to P then GSL there is anincreasing ease of public access tomedication and an equivalent decrease inprofessional control and vice versa. Withinthis framework are ‘controlled drugs’
(CD) which are subject to additionalcontrols, and herbal medicines which areleast controlled (see Table 1).
Although this paper is about the OTCmarket, which is traditionally understoodto be P and GSLmedicines, it is importantto be aware of POMmedicines as the threecategories together contribute to the phar-maceutical market which is in dynamicequilibrium. When a new medicinalcompound is first licensed for use by thepublic in the UK, and depending on theevidence of safety and efficacy in the pre-marketed period, it is classified as POM.After two years this classification defaultsto P unless there is a specific application toretain the POM status, which is the morenormal practice. Subsequent moves toreclassify a medicine require a rigorousprocess of evidence submission to, andconsultation by, the MHRA (Medicinesand Health care products RegulatoryAgency). In Europe there is also clearguidance on the criteria to be applied whenretaining a medicine in the POM category(Directive 92/26/EEC). These aresummarised in Box 1.
In general, a large subset of POM medi-cines and a smaller proportion of P andGSL medicines are supplied within anational state health care system, throughsystems ranging from ‘no cost’ to thepatient (for example, Wales) to co-payment systems based on a range of
The over-the-counterpharmaceutical market –policy and practice
Christine Bond
Summary: The European non-prescription medicines and consumer over-the-counter (OTC) self-medication market is today worth some €29 billion atconsumer prices and represents 36% of world sales.1 In this personal reflectionfrom a UK perspective, I consider the background to and changing context ofOTC medicines, the implications for the pharmacy profession and patients, andthe benefits and challenges.
Keywords: Over-the-counter Pharmaceuticals; Pharmaceutical Policy, UK
Christine Bond is Professor of PrimaryCare: Pharmacy and Head of Centre ofAcademic Primary Care, Aberdeen,Scotland. Email: [email protected]
measures adopted should pursue the goalof improving the health of the populationby tapping into the professional qualifica-tions of pharmacists that are currentlywasted on task of lesser importance. Thisis not so much a question of improvingeconomic benefits, but of moving towardsa sector design that corresponds with thecurrent drug-provision cycle. Thisapproach would thus account for thechanges that have taken place in recentyears, rather then continuing to perpetuatewhat is now an outdated image of thesector.
REFERENCES
1. Indecon. Review of Pharmacy WholesaleMargins. Naas: Health Service Executive,2007. Available at http://www.hse.ie/en/Publications/HSEPublicationsNew/PCCCReports/IndeconReport/
2. Volkerink B, de Bas P, van Gorp N,Philipsen N. Study of Regulatory Restric-tions in the Field of Pharmacies. Rotterdam:ECORYS Nederland BV, 2007. Available athttp://ec.europa.eu/internal_market/services/docs/pharmacy/report_en.pdf
3. Philipsen NJ, Faure MG. The regulationof pharmacists in Belgium and the Nether-lands: in the public or private interest?Journal of Consumer Policy2002;25:155–201.
4. Organisation for Economic Cooperationand Development. Competition and regu-lation issues in the PharmaceuticalIndustry. Paris: OECD, 2001.
5. Matias L. Regulation of ProfessionalServices. Presentation of the Pharmaceu-tical Group of the European Union atConference on the Regulation of Profes-sional Services. Brussels: Commission ofthe European Communities, 2003.Available at http://ec.europa.eu/comm/competition/sectors/professional_services/conferences/20031028/
6. Huttin C. A critical review of theremuneration systems for pharmacists.Health Policy 1996;36:53–68.
7. Council of Europe. Resolution ResAP(2001) 2 concerning the pharmacist’s role inthe framework of health security. Availableat http://www.correofarmaceutico.com/adiccion/CEResolucionOFU21.pdf
8. Taylor D, Mrazek M, Mossialos E.Regulating pharmaceutical distribution andretail pharmacy in Europe. In Mossialos E,Mrazek M, Walley T (eds). RegulatingPharmaceuticals in Europe: Striving forEfficiency, Equity and Quality.Buckingham: Open University Press, 2004.
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different models (for example, France orEngland). Whilst most of the POM medi-cines would fall within a state healthsystem, OTC drugs, sold to the public,more generally become part of privatehealth care.
Since the late 1980s in Europe, and morerecently in other parts of the developedworld such as the USA and Australia, therehave been moves to increase the numbersof medicines available OTC, and the aboveEuropean criteria and re-regulationprocesses have been extensively appliedand adopted. The rationale for these moveshas been multifactorial. Firstly, as drug
budgets have continued to rise year onyear there has been a wish to transfer drugdistribution costs from the government tothe individual consumer. It is also said thatthis shift in responsibility for care from theprofessional to the individual consumerwill empower the public, widen access tomedicines2 and bring additional financialreturn to the pharmaceutical industry,particularly for drugs nearing the end oftheir protected, patent, period.
The trend to deregulation from POMstatus has also been supported by thepharmacy profession3 as a way ofextending the range of effective advice and
treatments they can provide to patientspresenting symptoms in community phar-macies. In general, the medical professionhave supported the deregulation in prin-ciple,4 although caveats have beenexpressed for certain specific medicines. Arecurring issue is whether or not, asprofessionals, pharmacists are qualified todiagnose, a skill which is clearly the firststep when considering the patient’ssymptoms and considering ‘prescribing’.This is despite the fact that in the early20th century, and in the UK specificallybefore the introduction of the NHS in1948, many people obtained the vastmajority of their advice and treatmentfrom their local pharmacist, depending onwhat were known as ‘Chemist’sNostrums’ to cure their various ills.
Bearing in mind these concerns therefore,the first medicines to be deregulatedtended to be for conditions that pharma-cists had historically diagnosed, such asdiarrhoea. Indeed loperamide was one ofthe first of the recent tranche of deregula-tions providing a safe and effective remedyin lieu of the traditional codeine or otheropiate-based remedies (1983). As timewent on, and as the confidence of thepublic and opinion leaders in health grew,medicines already available for an estab-lished diagnosis, for example, hydro-cortisone for contact dermatitis, wereproposed for deregulation for additionalindications such as eczema, and for longerterm use. The final and then logical movewas to deregulate new medicines for newdiagnostic areas, whilst operating withinthe European framework. Examples of
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Box 1: European criteria for retaining amedicine in the POM category
• There is direct or indirect danger to healthif the medicine is used without medicalsupervision (for example the ADR (adversedrug reaction) profile needs a doctor toassess risk–benefit,. or misdiagnosis mightlead to the patient being put at risk);
• The medicine is frequently used incorrectlyleading to direct or indirect danger tohealth (for example, products liable tomisuse);
• The activity of the drug or the side effectsrequire further investigation;
• The drug is parenterally administered.
Figure 1: Progress from POM to P and overall cultural change
A cultural leap (1983–2005)
Traditional area of careMedicine already OTC
(dyspepsia treated with antacids)
New area of careMedicine already OTC
(hydrocortisone for eczema)
Traditional area of careNewly deregulated medicine
(dyspepsia treated with H2 blocker orproton pump inhibitor)
New area of careNewly deregulated medicine
(simvastatin for hyperlipidaemia)
Based on Sue Kilby, Royal Pharmaceutical Society of Great Britain, personal communication.
Minor self-limiting conditions
Chronic conditions
Table 1: UK medicines classification and implications for supply, record keeping and professionalcontrol
Classification Supply controls Record keeping Level of control
CD Misuse of DrugAct schedules
Special supplyregulations apply
Records incontrolled drugsregister androutine records
Most professional control– least patient control.Hardest to access
POM Prescription onlymedicine
Prescribed by specifiedhealth care professional
Record kept
P Pharmacistsupervised sale
Sold by or under thesupervision of apharmacist
Record rarely kept
GSL General SalesList medicine
Available from anyretail outlet
Record never kept
Herbal New regulationsimminent
Available from anyretail outlet and some selfappointed specialist shops
Record never kept Most patient control –least professional control.Easiest to access
such a move in the UK are the deregu-lation of the Emergency HormonalContraceptive pill (levonorgestrel) and thelipid lowering drug simvastatin (Figure 1).
Implications for pharmacy practiceAs noted, whilst a large part of therationale for deregulation came from theindustry and health policy makers, thepharmacy profession supported the movebecause it provided an opportunity fortheir members to use their skills morefully. The professional pharmacy bodieshave played a key role in the deregulationprocess which has contributed to theparadigm shift of community pharmacistsfrom a technical supply orientated role toa more clinical cognitive role. Indeed,whilst some of the deregulation moveswere driven by the industry for specificproprietary products, other moves forderegulation of a general product havecome from the profession. This change inrole to utilise the profession more fully inan integrated health care service has beenincreasingly recognised in UKGovernment policy papers since its earlymention in the publication of the Nuffieldreport on pharmacy on 1986,5 culminatingin recent pharmacy strategies in the coun-tries of the UK. The better use of
community pharmacy also reflects theshifting balance of care from hospital tocommunity.
One of the other results of the changingparadigm of pharmacy has been the impacton the remuneration of pharmacists. In theUK, as in many other countries, pharma-ceutical remuneration has been tradi-tionally linked to the volume of itemsdispensed against prescriptions. This wasinitially an appropriate basis, given theskilled compounding required. However,as manufactured proprietary productsbecame the norm, the professional contri-bution to the dispensing process, whilststill a key component of a safe supplyprocess, in providing a final clinical checkon a medicine, became reduced. Otherroles, such as general health care andlifestyle advice, also were increasinglydelivered either out of goodwill for reasonsof professionalism, or formally paid for aspart of locally negotiated agreements.Until recently, these were not remuneratedon a national basis. New contracts in theUK, introduced in the early 21st centuryhave changed the basis for remuneration toone which recognises these other non-supply oriented services.
Deregulation has contributed to this more
general move for pharmacists to be seen asclinicians in their own right. In the UK, aswell as being able to sell a wider range ofpotent OTC medicines, they have alsoincreasingly acquired a right to supplymedicines under the NHS, including OTCproducts through mechanisms such as theMinor Ailments Schemes, Patient GroupDirectors and direct prescribing rights.Further discussions of these are outwiththe scope of this paper, but are mentionedas an important illustration of how it is notpossible to change one component of acomplex professional remit withoutaffecting other components.
European perspectiveWhilst the detail of this paper is drawnfrom experience in the UK it can beregarded as a proxy for the rest of Europe.However, there are variations acrossEurope despite initiatives to achieve ageneral harmonisation of pharmaceuticalregulations. In most, if not all, countriesthe concept of deregulation of medicinesfor OTC sale has been replicated althoughthere are interesting differences in detail ofwhat is, and is not, available across thedifferent countries as Table 2 illustrates.This is despite the fact that the principlesof retaining a drug with a POM status are,
as previously stated, guided by Europeanstandards. However, in general, policy onpharmacy and access to medicines isprobably more visionary in the UK thanin most, if not all, other European coun-tries.
Other European differences include theexact nature of the POM, P and GSL cate-gories. In the UK and France, medicines inthe P category can only be sold ‘under thesupervision’ of a pharmacist from a regis-tered pharmacy, but GSL products areavailable from any retail outlet, includingpharmacies. In Italy, the equivalent of P andGSL medicines exist as SOP (senza obligodi precizole) and PDB (prodotto di banco),but both are only available in pharmacies.The difference between the categories isthat the GSL equivalent category, the PDB,is available for customer self selection andcan be advertised directly to the public. Inthe Netherlands, as in USA, there are onlyPOM and OTC categories. Dutchpharmacies focus much more on POMmedicines and have a minority role in thesale of OTC products, 75% of which aresold from ‘drogisten’ (chemists). Theseintermediate outlets are neither registeredpharmacies nor general retail outlets.
Benefits and challenges of wideravailability of OTC medicinesAs noted earlier the rationale for deregu-lation of medicine is said to have beendriven by government, the profession andthe industry. The success of deregulationfrom these interlinked perspectives willnow be considered.
From the government’s perspective dereg-ulation is part of a philosophy to increasesafe and convenient access to medicines,empower the public and encourage themto take greater responsibility for their ownhealth. This is also part of a wider agendarecognising that most people actuallyunderstand their own needs and symptomsbetter than the professional and that thebest way to treat them is in partnershipwith the health care professionals. Thus,the ‘expert patient’ programme6 and medi-cines partnership initiatives (seehttp://www.npc.co.uk/med_partnership)have emerged. Whilst the focus of theformer is more on prescribed medicines,the latter encompasses both prescribed andOTC medicines, and for OTC medicinessold from pharmacies the health profes-sional who provides the advice andguidance is the pharmacist, or thepharmacy assistant. Increasingly in the UKthe previously untrained pharmacy
assistant is becoming professionalised.Mandatory training has been in place since1996, and more recently encouragement tobecome qualified as a pharmacy technicianand registered with the RPSGB.
The role of pharmacists and their staff withrespect to OTC medicines is therefore toensure, as far as possible, that medicinesare sold within the conditions of the OTClicence (which may be more restricted thanthe indication for prescribed use), that thepotential for drug interactions (with bothother OTC and prescribed medicines) isassessed and avoided, and that people withcontra-indications are not sold the prepa-rations.
Using one of the most frequently soldOTC drugs, ibuprofen, as an example, thisnon steroidal, anti-inflammatory analgesicshould not be used long-term (more thanseven days continually), should not beused together with other non steroidalanti-inflammatory drugs or some anti-hypertensive medications, and should notbe taken by people with a history of pepticulcer disease or asthma.Whilst this appearsdeceptively simple to deliver, in practicewe know that this guidance is not adheredto, as a long term follow up study ofpurchasers of ibuprofen7,8 and a generalpublic survey9 showed (see next section).
The challenge therefore is to empowerpharmacists and their staff to provide moredirective advice to people buying medi-cines, without compromising the prin-ciples of increased public access tomedicines and public empowerment. Untilthe recent rounds of deregulations, overthe past twenty years, most of the drugssold OTC did not have any body ofpublished information to support evidencebased use. Indeed, there is little evidence atall for many of the much hyped and adver-tised cough and cold remedies traditionallysold.10 This is not, however, the case for allOTC treatments, particularly the newlyderegulated products such as analgesics,products for gastrointestinal problems(antacids and antiulcer) and dermatologicalproducts.
As with prescribed medicines, knowledgeof all factors required for ‘safe’, clinicallyeffective supply does not necessarilytranslate into practice. For OTC sales thepharmacy staff (pharmacists and non-pharmacists) must have all the knowledge,they must be able to communicate it to thepurchaser and also obtain informationfrom the purchaser on relevant medicalhistory to ensure appropriate management
recommendations are made. This is notalways easy. Use of algorithmic guidelinessummarising the necessary knowledgehave been shown to be acceptable to andpopular with staff,11 but have not neces-sarily supported evidence based productsupply.12
For some years a mnemonic WWHAM(Who is the medicine for, What is themedicine for, How long have thesymptoms been present, Actions alreadytaken, Medicine taken for other reasonsprescribed or otherwise) has been used asan aide memoire to remind pharmacy staffof the generic questions to be asked, andinformation needed to support everyOTCsale. Whilst pharmacy staff state they usethe mnemonic and find it useful,13 inpractice not all the questions are routinelyasked.14 Where more questions are asked,the sale is more likely to be appropriate.Reasons often cited for not asking thequestions included lack of customer recep-tiveness and time.
There should therefore be a policy agendato raise public awareness of the need totreat OTC medicines with respect. Theymust be reminded that, despite beingadvertised to the public (in contrast toPOM medicines in many countriesincluding the UK), OTCmedicines are notjust an ordinary commodity, and thatchange in regulatory status from POM toP has not changed a drug or its potential tocause side effects. There is early researchevidence which suggests that the publicperceive OTC medicines to be safer andless effective than POM medicines(unpublished work by the author andcolleagues) which could explain thecurrent attitude of many of the public togiving information OTC. Mechanismscould build on the fact that when experi-encing symptoms of minor illness such ascolds and flu the pharmacist is their firstpreferred option15 for advice.
To what extent has deregulation increasedthe market for medicines no longerprotected by patent and to what extenthave costs shifted from the government tothe patient? Two of the early deregula-tions, loperamide and topical hydrocor-tisone, were said to have saved the UKNHS £4.2 million and £2 million perannum respectively in 1987.16 SimilarSwedish research estimated that the dereg-ulation of sixteen different products hadsaved $400 million per annum.17However,it is not possible to generalise across alldrugs from this data, as each product willbe different.
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For example, consider a product for anacute condition, such as topical acyclovirfor the treatment of cold sores (herpes andsimplex). This was deregulated in 1993,and routine data indicate that prescriptionsfor this product fell sharply and remainedlow.18 Thus supply was changed fromNHS supply to OTC supply. In contrast,this drop in prescribed volume was notobserved for the anti-ulcer H2 blockers,such as cimetidine, famotidine andrantidine. It is suggested that OTC avail-ability widened the target population, andthat people transferred from self-treatmentof dyspepsia with simple cheap antacids tothe more expensive newer products.However, once realising their effectiveness,long term use was translated back intoincreased prescription use. Thus, in thisinstance, the overall market increasedprobably in both the NHS and self carearena. This pattern has also seen observedwith antihistamines.19 Economicmodelling based on consumer surplus alsoprovides theoretical understanding of theabove observed effects. If the acquisitioncost of the drug is cheaper over the counterthere will be financial benefits for bothpatient and government.20,21
Disadvantages of deregulationWhilst the deregulation of medicines hasmany benefits, as already outlined, thereare also some disadvantages. It isimportant to be aware of and address theseissues, rather than allowing them to ulti-mately result in reversal of the policy.
Firstly, side effects and adverse events frommedicines are an important and well recog-nised consequence of the pharmacologicalactivity of a drug. Although the licensingprocedures include requirements forevidence of safety in the context of use, itis only once a medicine is used by peoplein that context that ‘real world’ circum-stances apply. Thus whilst newly launchedPOM medicines are deemed safe on thebasis of the pre-launch clinical trial data, itis often only after product launch, and useby larger numbers of people with a rangeof co-morbidities and taking concurrentmedication, that rare but potentially fatalside effects are identified.
This is likewise the case when a medicine isderegulated from POM to P and is used byan even wider range of people, without theindividualised, normal medical advice thatwould have supported prescription use.Examples of medicines subsequentlyneeding to be reclassified include the anti-histamine terfinadine and the anti head lice
treatment carbaryl. Moreover, as alreadynoted, once a medicine is badged P orGSL, there is emerging evidence that thepublic no longer respect its potency in thesame way that they would if it were aPOM medicine. It is therefore no wonderthat after purchase of a P or GSLmedicine,a significant number of purchasers use itoutwith the conditions of the OTC licenseas described below.
Drug safety depends on appropriate use(i.e. at the right dosage, for the right indi-cation, and in the absence of contraindica-tions), and knowledge of the adverse eventprofile of the drug and its interactions.Long term follow up studies ofpurchasers/users of ibuprofen (a proxy forother OTC drugs) shows that if thesecriteria are applied there maybe cause forconcern.7,8 The current OTC dosage is1–2g ibuprofen daily, in divided doses, fora maximum of seven days, yet this studyfound that 38% of purchasers/users (whoresponded to the study questionnaire)were taking it for chronic conditions(defined as having been experienced formore than thirteen weeks). Nearly aquarter had been using ibuprofen regularlyfor more than eight weeks, 8% hadexceeded the maximum OTC daily dose(and 1% the maximum prescribed dose).People were, in general, using it for appro-priate conditions but not in the absence ofcontraindications. 4% had a history ofstomach ulcer, 7% a history of asthma, 4%had sought advice about gastro-intestinalsymptoms during the week after purchase,7%were using concurrently with a gastro-intestinal medicine and 4%with an asthmamedicine. Finally 38%were using it with amedicine with a potential for interaction:27% with another analgesic, 11% with anantihypertensive and 8% with a diuretic.
Ways to avoid these drug interactions needto be considered, such as enhanced NHSrecord keeping, access for pharmacists toselected parts of the medical records, andincreased public and professionalawareness. So whilst most OTCs probablyare theoretically safe, we need to be surethat this is the case in practice, and havesystems in place to prove this. We alsoneed to consider whether the level of sideeffects experienced is commensurate withthe benefit. A side effect profile which isacceptable for a treatment which prolongslife in advanced cancer will be quitedifferent from one for a lifestyle medicine.
Pharmacovigilance systems, designed tomonitor and identify side effects also needto take these different criteria into account.
At present in the UK the main system ofpharmacovigilance, the Yellow CardSystem (http://yellowcard.mhra.gov.uk/the-yellow-card-scheme), only requires alladverse events to be reported for newlylaunched medicines; only life threateningevents are invited for established medi-cines. As more medicines are deregulatedit may be necessary to change these criteriaso that unacceptable prevalence levels ofunpleasant, but not severe, side effects aredetected. This requires public and profes-sional campaigns. Whilst there is a dangerof overwhelming the routine pharma-covigilance system, increased automationin reporting (for example on-line) andimproved analysis should mean this can beaccommodated. A problemwith the signalgeneration system which depends onspontaneous reporting is that the reporterhas to make the association between thedrug (the cause) and the effect, beforethinking of reporting it. Once again theperceived safety of OTC medicinesbecomes an issue and people, both profes-sional and the public need to be remindedthat today’s OTC drug was yesterday’sprescription speciality.
In prescription drug monitoring, dedicatedfollow up exercises are an alternativemethod of pharmacovigilance usingroutinely held records to identify peoplewho have taken a drug and then reviewingrecords for any evidence of side effect ordrug interactions. However as no recordsare routinely kept of medicines suppliedOTC this is not possible, other than as adedicated follow up exercise, such as theibuprofen and hayfever follow up studiesreported above, and similar.7,19,22
So, the lack of record keeping of OTCpurchases is a problem, and one which itmay be hard to resolve. Although in theUK, where community pharmacies areincreasingly being linked to NHS ITsystems, a future mechanism to link OTCpurchases to a single patient record is tech-nically possible, this is not the case for allcountries and/or for GSL medicines soldfrom non-pharmacy outlets. Again, as ITdevelops, it may ultimately be possible toautomate this, with individual purchaserconsent, for example, through bar codingand swipe cards.
Finally, making medicines available overthe counter is inextricably linked to privatepurchase and therefore is an inequitablepolicy. Whilst there are cheaper ‘value formoney’ equivalents of well establishedmedicines such as paracetamol available forOTC purchase this is not the case for the
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newer deregulated medicines. Thus, thosewho are less affluent are disadvan-taged.23–24
A national initiative to address this hasrecently been introduced in Scotland,based on earlier research in England25 aspart of a revised community pharmacycontractual framework. In this newframework a Minor Ailment Service(MAS) is one of the four core servicesdelivered by all community pharmacies.People, who would normally be exemptfrom prescription charges (on the groundsof income, age or morbidity) can access,free of charge on the NHS, a range ofOTC medicines from the pharmacy. Thistherefore removes the inequity of accessintroduced by private purchase but runscounter to any cost shifting from thepublic to the private purse. The MASscheme has been carefully developed andincludes computerised registration of thepatient at a particular pharmacy with NHSrecords maintained containing the patient’sunique NHS identification number (theCHI – Community Health Index). Acurrent shortcoming of the system is that itdoes not link to other health records, suchas the general practitioner (GP) heldmedical record, although there are longerterm plans to address this. Therefore, inthe short term GPs need to continue toremember to ask about, and patients needto report, use of OTC medicines. At themoment this does not always happen.26
ConclusionRecent moves have increased the range ofmedicines available without a prescription.This move has potential benefits for allstakeholders. However for these benefitsto be fully realised issues of recordkeeping, pharmacovigilance and public andprofessional attitudes all need to beresolved. Whilst many of the potentialrisks can be contained within a pharmacyenvironment, this is more complex in ageneral retail environment, and in coun-tries where the P and GSL categories aredistinct, the secondary stage of deregu-lation from P to GSL should be consideredextremely carefully.
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1. Dudley J. OTC Distribution in Europe.Kidderminster: James DudleyInternational, 2007.
2. Brass EP. Changing the status of drugsfrom prescription to over-the-counter
availability. New England Journal ofMedicine 2001;13;345:810–16.
3. Bond CM, Sinclair HK, Taylor RJ,Winfield AJ. Community pharmacists’attitudes to the deregulation of medicinesand to their extended role. InternationalJournal of Pharmacy Practice 1993;2:26–30.
4. Sihvo S, Hemminki E, Ahonen R.Physicians’ attitudes toward reclassifyingdrugs as over-the-counter. Medical Care1999;37(5):518–25.
5. Nuffield Foundation. NuffieldPharmacy: A Report to the NuffieldFoundation. London: Nuffield Foundation,1986.
6. Department of Health. The ExpertPatient: A New Approach to ChronicDisease Management for the 21st Century.London: Department of Health, 2001.
7. Sinclair HK, Bond CM, Hannaford PC.Long term follow up studies of users ofnon-prescription medicines purchasedfrom community pharmacies: somemethodological issues. Drug Safety2001;24(12):929–39.
8. Sinclair HK, Bond CM, Hannaford PC.Over the counter ibuprofen: how and whyis it used? International Journal ofPharmacy Practice 2000;8;121–7.
9. Porteous T, Bond CM, Hannaford P,Sinclair H. How and why are non-prescription analgesics used in Scotland?Family Practice 2005;22:78–85.
10. Schroeder K, Fahey T, Systematicreview of randomised controlled trials ofover the counter cough medicines for acutecough in adults. British Medical Journal2002; 324:329–32.
11. Bond CM, Grimshaw JM, Taylor RJ,Winfield AJ. An evaluation of clinicalguidelines for community pharmacy.Journal Social and AdministrativePharmacy 1998;15(1):33–39.
12. Watson MC, Bond CM, Grimshaw JM,Mollison J, Ludbrook A, Walker AE.Educational strategies to promote evidencebased community pharmacy practice: acluster randomised trial (RCT). FamilyPractice 2002;19:529–36.
13. Watson MC, Bond CM. The evidencebased supply of non-prescriptionmedicines: barriers and beliefs.International Journal of Pharmacy Practice2004;12:65–72.
14. Watson M, Bond C, Grimshaw J,Johnston M. Factors affecting the guidelinecompliant supply (or non supply) of non-prescription medicines in the communitypharmacy setting. Quality and Safety inHealth Care 2006;15:5307.
15. Porteous T, Ryan M, Bond C,Hannaford P. Preferences for self-care orconsulting a health professional in minorillness; a discrete choice experiment BritishJournal of General Practice 2006;911–17.
16. Ryan M, Yule B. Switching drugs fromprescription-only to over-the-counteravailability: economic benefits in theUnited Kingdom. Health Policy1990;16:233–39.
17. Carlsten A, Wennberg M, Bergendal LJ. The influence of Rx-to-OTC changes ondrug sales. Experiences from Sweden1980–1994. Clinical PharmaceuticalTherapy 1996;21(6):423–30.
18. Bond CM. Prescribing in CommunityPharmacy: Barriers and Opportunities.PhD thesis. Aberdeen: University ofAberdeen, 1995.
19. Sinclair H, Bond C, Largue G, Price D,Hannaford P. Community pharmacyprovision of allergic rhinitis treatments: alongitudinal study of patient reportedoutcomes. International Journal ofPharmacy Practice 2006;13:249–56.
20. Ryan M, Bond CM. Dispensing doctorsand prescribing pharmacists Pharmaco-economics 1994;5(1):8–17.
21. Shih YC, Prasad M, Luce BR. Theeffect on social welfare of a switch ofsecond-generation antihistamines fromprescription to over-the-counter status: amicroeconomic analysis. Clinical Therapy2002;24(4):701–16.
22. Stewart D, Helms P, McCaig D, BondC, McLay J. Monitoring adverse drugreactions in children using communitypharmacies: a pilot study. British Journal ofClinical Pharmacology 2005;59:677–83.
23. Schafheutle E, Cantrill J, Nicolson M,Noyce P. Insights into the choice betweenself medication and a doctor’s prescription:a study of hay fever sufferers. InternationalJournal of Pharmaceutical Practice1996;4:156–61.
24. Payne K, Ryan-Woolley B, Noyce P.Role of consumer attributes in predictingthe uptake of medicines deregulation andNational Health Service prescribing in theUnited Kingdom. International Journal ofPharmaceutical Practice 1998;6:150–58.
25. Whittington Z, Cantrill J, Hassell KJ,Batres F, Noyce P. Community pharmacymanagement of minor conditions – the‘Care at the Chemist’ scheme. ThePharmaceutical Journal 2001;266:425–28.
26. Urquhart G, Sinclair HK, HannafordPC. The use of non-prescription medicinesby general practitioner attendees.Pharmacoepidemiology and Drug Safety2004;13:773–79.
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Japan has a Bismarck-type compulsorysocial health insurance system.1 Theuniversal system, which covers 122 millionpeople, is divided up according to type ofemployment and place of residence.Although thousands of independentinsurance funds exist, they are all inte-grated within a government mandatedframework. For employees, the type of
company determines the insurance fund inwhich they are enrolled and the level ofcontributions that they must make. Theself employed and retired are covered by acommunity-based health insurancescheme.
The Japanese health financing system haslong been based upon fee-for-service (FFS)reimbursement using a national priceschedule. The health insurance funds, bothpublic and semi-public, gather premiumsfrom their members and reimburse thecosts of treatment according to type andvolume of services provided (Figure 1).
Health care expenditure in Japan hassteadily increased (Table 1), and there has
been continuing discussion over severaldecades on how to contain these costs.While payers argue that costs are exhor-bitant, service providers insist that thegovernment does not allocate enoughresources to services, pointing to the rela-tively low level of health care expenditure,8% of GDP in 2004, compared with 8.3%,10.6%, 10.9% and 15.3% in the UK,France, Germany and the USA respec-tively.2 One ongoing problem is the lack oftransparency in service provision,including a lack of appropriate data toevaluate medical services.
As the health system has been based on afine tuned FFS system, there are little
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Development and use of theJapanese 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 carehospitals in 2003. Covering more than 90% of acute in-patient care, ithas become one of the important sources of information for health policy.Using this dataset, the authors have analysed the impact onchemotherapy regimens.
Keywords: Case-mix, Diagnostic Resource Groups, Chemotherapy, Japan
Shinya Matsuda is based at theDepartment of Preventive Medicine andCommunity Health, University of Occu-pational and Environmental Health,Japan.
Kohichi B Ishikawa is based at theStatistics and Cancer Control Division,National Cancer Center.
Kazuaki Kuwabara is based at theDepartment of Health Care Adminis-tration and Management, GraduateSchool of Medical Sciences, KyushuUniversity.
Kenji Fujimori is based at the Division ofMedical Management, HokkaidoUniversity Hospital.
Kiyohide Fushimi is based at theDepartment of Health Policy and Infor-matics, Tokyo Medical and DentalUniversity Graduate School of Medicine.
Hideki Hashimoto is based at theDepartment of Health Economics andEpidemiology Research, School of PublicHealth, Tokyo University.
Figure 1: Structure of social health insurance scheme in Japan
Organisation forreview and payment
Insurer
Medical facilitiesInsured
Nationalgovernment
contribution
subsidy
payment
payment
demand with claim
demandwith
claim
medical services
co-payment (10–30%)
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HEALTH POLICY DEVELOPMENTS
detailed claim data, containing informationsuch as diagnosis, procedures conducted,drugs prescribed etc. Claims data have notbeen standardised or coded electronically,limiting their use in health policy making.One key objective of the new case-mixsystem (DPC – Diagnostic ProceduresCombination) is to implement a stan-dardised electronic claim system, withkeywords that provide transparency andaccountability. In future, it should bepossible to evaluate the cost and quality ofmedical services. This article, explores howthe new DPC can be a tool for greatertransparency in the provision of medicalservices.
Case-mix system developmentFrom the late 1990s, the Ministry ofHealth, Labour andWelfare (MHLW) andits affiliated research institute, the Instituteof Health Economics and Policy (IHEP)explored the feasibility of introducing acase-mix classification system as a tool ofstandardised medical profiling andpayment. A number of case mix systemswere tested for validity. While some USDiagnostic Related Group systems werethought to be applicable to Japanese acute-care hospitals, they were criticised as beingtoo rough to correctly reflect practice
patterns by the physicians association.They did however acknowledge thenecessity of case-mix profiling as a tool toimprove transparency. It was thereforedecided to develop an original classifi-cation system that fits with practicepatterns in Japan, while allowing compar-ative benchmarking nationwide and withsystems in other countries.
The use of DRGs in eight westernEuropean countries was also investigated.As a result it was decided to develop thenew case-mix system as a profiling tool formedical services in line with the principlesof the Dutch Diagnose BehandelingCombinatie (DBC). Also of greatinfluence were the French and Austrianapproaches to case-mix applications forregional health planning, and the Belgianand English approaches towards the incre-mental development process.
The structure of DPCThe DPC Project team made use of aDBC-like data gathering process and aPMC (Patient Management Category)-likeseverity setting.3 The first step in devel-opment was to construct a definition table(see Table 2). For the diagnostic category‘Malignancy, Respiratory System’ a
number of specific indications are listed,for example, ‘Malignant neoplasm ofTrachea (C33)’ or ‘Carcinoma in situ ofbronchus and lung (D022)’. After consul-tation with an expert panel on typicalprocedures for each diagnosis, as well aspotential co-morbidities and complica-tions, the research team constructed theDPC groups.
In the DPC algorithm, diagnosis,procedure, and co-morbidity/compli-cation are the three key variables for clas-sification. Additional information (forexample, birth weight in the case ofneonatal intensive care) is also referred toin some groups. Diagnosis and co-morbidity/complications were codedusing the International Classification ofDisease Version 10 (ICD10) scheme, withprocedures coded in the JapaneseProcedure Code, as defined in the feeschedule of the national health insurancesystem.
The structure of DPC version 3 has eightcomponents (Figure 2). This includes theMajor Diagnosis Category (MDC) andDPC serial number (DX) correspondingto ICD10 category, which indicates thetype of admission. It should be noted thesecomponents are for profiling, and not all
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
DPC Reimbursement SchemeThe DPC based reimbursement scheme isquite different to that in other countries.Payment to hospitals has both a DPCcomponent and a FFS component. TheDPC component relates to the hospital fee,comprising hotel fee and costs incurred inhospital wards for pharmaceuticals,supplies and diagnostic procedurescheaper than 10,000 Yen (US$10). The FFScomponent refers to tariffs for surgicalprocedures and anaesthesia, pharmaceu-ticals and expensive devices used in oper-ating rooms, and procedures of more than10,000 Yen. For the DPC component, aper diem payment schedule is set for eachDPC group.
Figure 3 provides an example of a DPCpayment. For each DPC grouping, thestandard per diem payment is defined, andthree periods are set for reimbursement:period I, period II and ‘upper limit’ for
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Table 2: Example of DPC definition table – Malignancy, respiratory system
BaseDPC
Principal diagnosis Principal surgery Additional surgery Adjuvant therapy Co-morbidity/complication
**: For chemotherapy, there is a special list in which a specific MHLW code is allocated to each drug.
Mal
igna
ncy,
resp
irato
rysy
stem
Figure 2: Structure of DPC code
04 0040 x x 01 x 4 x x04 MDC
0040 Code for Dx
x Type of admission
x Age, birth weight, Japan Coma Scale
01 Sub-code for principal surgicalprocedures
01 etc: code for surgical procedure in definition table99: no surgical procedure
x Sub-code for additional surgicalprocedures
0: none1: exist
4 Sub-code for adjuvant therapy 0: none1 etc: code for adjuvant procedures
x Sub-code for CC 0: none1: exist
x Sub-code for severity
x = not applicable
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DPC-based payment. These periods arelinked to average length of stay. In periodI, per diem payment is set for 50% morethan the standard per-diem payment.Furthermore, the hospital coefficient iscalculated for each facility according to itsfunction and characteristics. From periodII to the upper limit day, per diem paymentis set at 15% less than the standardpayment. Over the upper limit day areduced FFS payment scheme will beapplied. The system has been fullycomputerised given its complex nature,including special computerised softwarefor ICD coding to aid clinicianscompleting DPC information sheets fortheir patients.
Making use of the DPC database forhealth policyCancer has been a leading cause of death inJapan, with one person in three dying fromthe disease. More people are dying ofcancer as the population gets older.Combating cancer is an increasinglyserious issue for health policy makers.However, analysts have criticised the widevariations in the accessibility and qualityof cancer care among the different regionsand institutions. In order to furtherameliorate cancer, the MHLW establisheda ‘Comprehensive Ten-Year Strategy forCancer Control’ in 2006. One of the mostimportant objectives of the Strategy is toassure the equal access to quality cancertreatment for the entire population. This
requires analysis of the current use oftreatments – something that can now beachieved making use of DPC data. Thiscan help facilitate a movement towardsgreater use of evidence based medicine andquality assurance in cancer care.
Table 3 shows, ten of the thirty mostwidely regimens used for chemotherapy inlung cancer patients in 242 acute carehospitals in the DPC system between July
andOctober 2006.5 The data indicates that17,200 lung cancer patients receivedchemotherapy using 659 differentregimens, with the most frequently appliedregimen being carboplatin plus paclitaxel,which was used by 3,243 patients in 189hospitals. The same data set was also usedto identify frequency of drug use in lungcancer patients (Table 4). Carboplatin wasthe most frequently used drug: 6,754 cases
3129 points
Period I(16 days)
Period II(31 days)
180 days
Special fixed fee2SD
Upper limit forDPC-based payment
(62 days)
2320 points
1572 points
Poin
tspe
rdie
m
Figure 3: Example of DPC-based payment for hospital
Table 3: Top ten chemotherapy regimens for lung cancer in Japanese hospitals (2006)
Regimen Number of hospitalsShare of totalhospitals (%)
DPC 040040xx01x4xx (Malignacy, Respiratory system, lebectomy and/or tracheostomy(including endoscopic). Chemotherapy without radiation. No CC)
(39.3%), followed by paclitaxel (23.3%)and cisplatin (19.6%). Among the 659regimens, 216 regimens contain carbo-platin (32.8%), 199 regimens containcisplatin (30.2%) and 130 contain pacli-taxel (19.7%). This indicates that carbo-platin and cisplatin are the main elementsof chemotherapy for lung cancer in Japan.5
ConclusionToday the DPC programme covers morethan 90% of acute in-patient care,including cancer, cardio-vascular diseaseand injuries. In 2007, 1,426 hospitalsparticipated in the DPC programme,covering approximately 450,000 acute carebeds. It was expected that another 200hospitals would join the project in 2008.The same methodology, using the DPCframework, is now being applied to out-patient services.6 This implies that use ofthe DPC database, can allow one toanalyse the whole process of treatmentfrom a clinical and economic viewpoint.
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Table 4: Top fifteen chemotherapy drugs for lung cancer in Japanese hospitals (2006)
Outcome reearch for lung cancer, small cell• cisplatin - irinotecan• cisplatin + etoposide
Hospitaldatabase
Hospital B
Hospital C
Hospital A
Extraction ofpossible cases
Additionalinformation
Large scale multi-centrepost-marketing clinical study
Survival studyCost Effectiveness AnalysisCost Utility AnalysisCost Benefit Analysisother health reearch
National DPCdatabase
Extraction of posible cases
Figure 4: Example of DPC based clinical study Lung cancer, chemotherapy (040040xx01x4xx)
Perhaps the single most potent lesson forother countries to learn from Canada is itsunique, federally-funded, independent,not-for-profit organisation called CanadaHealth Infoway (Infoway) whosemembers are Canada’s fourteen federal,provincial and territorial DeputyMinistersof Health. Created in 2001, Infowayinvests in a common, pan-Canadianframework of electronic health recordsystems where best practices andsuccessful projects in one region can beshared or replicated in another. Infoway isCanada’s catalyst for collaborative changeto accelerate the use of electronic healthinformation systems and electronic healthrecords (EHRs) across the country. Itrecognises and has to function in an envi-ronment whereby health care is aprovincial responsibility.
As in many countries, though the healthcare sector depends upon accurate, up-to-date information, it has been slow toexploit information technology (IT) –mainly because of cost and resistance tochange. For years, IT was a low priority in
health care and it is only recently thatgovernments have begun to realise thattechnology can improve the quality of careand actually save money in the long run.
As a strategic investor, Infoway works incollaboration with health ministries,regional authorities, other health careorganisations and information systemvendors to best align Infoway’s invest-ments with jurisdictional plans and toleverage existing solutions. Onceinvestment decisions are made, publicsector partners lead the development andimplementation of EHR solutions.Infoway views an EHR as a secure andprivate lifetime record of an individual’shealth and care history. Available electron-ically, it provides authorised health careprofessionals with immediate access totheir patients’ accurate health histories,including laboratory and radiology testresults, past treatments, prescription drugprofiles and immunisations, whileprotecting privacy and confidentiality. TheEHR supports improved clinical decision-making leading to more effective diagnosisand treatment, greater patient safety,increased efficiency and improved accessto services.
It is worth noting that in Canada, adistinction is made between the above
e-Health in Canada:Lessons for European healthsystems
Denis Protti
Summary: This paper provides a status report of health informationtechnology and electronic health record (EHR) initiatives in Canada. Italso candidly discusses the difficulties Canada is facing in moving the EHRagenda forward. Particular emphasis is placed on describing the uniquerole of Canada Health Infoway, a unique, federally-funded, independent,not-for-profit organisation whose members are Canada’s fourteen federal,provincial and territorial Deputy Ministers of Health. The interestinglesson learned is about a national organisation being successful in anenvironment whereby health care is a provincial responsibility.
Key words: Electronic Health Records, Funding Health IT,National Oversight, Electronic Medical Records, Canada
Denis Protti is Professor, School of HealthInformation Science, University ofVictoria, British Columbia, Canada.Email: [email protected]
The DPC database can also be used forlarge-scale multi-central post-marketingclinical studies as shown in Figure 4. In2008, the DPC research programme hasclinical studies for several disorders,including chemotherapy for lung andbreast cancer.
With limited resources available in thehealth sector, not all medical innovationscan be covered by the public medicalinsurance scheme. In order to make theJapanese health system sustainable,evidence for the rational distribution ofresources is needed. This requires infor-mation about medical procedures andtheir outcomes.
As the English National Health Serviceexperience has shown, under-financing ofthe health sector can damage the healthsystem. On the other hand, over-financingthe health system can damage the generaleconomy, because the Japanese healthsystem depends on contributions from thegeneral economy. Thus, there needs to bea balance between the health spending andthe needs of the broader economy.
The new DPC system can help providedetailed situation analysis of the use ofhealth care interventions among regions,in-patient and out-patient services, as wellas between acute and chronic care. At itsheart are the concepts of transparency andaccountability. By using this framework,researchers will in future be able toevaluate the quality of the health systemfrom both micro and macro perspectives.
REFERENCES
1. Matsuda S. Health Insurance System inJapan. Journal of Economics and Medicine2004;22:15–25.
2. OECD. OECD Health Data 2006.Paris: OECD, 2006.
3. Young WW, Kohler S, Macioce DP.Patient Management Categories, Release5.0. Pittsburgh: The Pittsburgh ResearchInstitute, 1992.
4. Ministry of Health, Labour and Welfare.DPC Definition Table 2004. Tokyo:MHLW, 2004.
5. Ishikawa BK, Matsuda S. Report of the2004 Study on the Cost Estimation ofMedical Services by Case-mix (suppl. 5)DPC portfolio for chemotherapyregimens, 2005. (in Japanese).
6. Matsuda S, Ishikawa BK, Kuwabara Ket al. Report of the 2006 Study on the CostEstimation of Medical Services by Case-mix, 2007. (in Japanese).
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defined EHR and an electronic medicalrecord (EMR). An EMR generally refersto computer-based clinical data of an indi-vidual that is location specific and kept bya single physician office or practice,community health centre, or possibly anambulatory clinic. Ideally, the two worktogether, with doctors’ EMRs connectedto wider EHR systems. Infoway’s goal isthat by 2010, 50% of Canadians (and100% by 2016) will have their electronichealth record available to those authorisedprofessionals who provide their health careservices.
The good newsWorking with its federal, provincial andterritorial partners, Infoway is attemptingto hasten the pace of development andimplementation of electronic healthrecords. During 2007–08, Infowayapproved $311.5 million in new projects,bringing the total cumulative value of itsinvestments to $1.457 billion or 89% ofInfoway’s $1.6 billion in capitalisation bythe federal government. This capitalisationincludes an injection of $400 million thatInfoway was allocated by the Governmentof Canada in the March 2007 Budget forinvestment in electronic health infor-mation and communications technology.
The investments have brought the totalnumber of projects underway to 254,representing a four-fold increase from thefifty-three projects that were underway in2004.1 For instance, in terms of Infos-tructure, there are twenty-four pan-Canadian projects of which fourteen havebeen completed and ten are active while interms of provincial client and provider
registries, twelve have been completed andseventeen are active. It should be notedhowever that the information in Table 1 isnot an account of all the projects underwayin Canada but only those that havereceived Infoway funding.
As in most countries, Canada can point toits centres of excellence and its crownjewels so to speak. A few of manyexamples at the provincial level are BritishColumbia’s PharmaNet system whichsince 1995, have connected all the phar-macies in the province to a centralisedmedication profile database. As a result,any pharmacy and hospital emergencydepartment in the province has 24/7 accessto all the medications any patient hasreceived in the previous fourteen months.An Infoway sponsored project will soongive that same access to physicians whohave EMR systems in their offices.
At a regional level, the Capital HealthAuthority based in Edmonton, Albertahad ‘islands’ of patient information untilApril 2004. After only eleven months indevelopment, Capital Health launchednetCARE, Canada’s first region-wide inte-grated EHR. For the first time, authorisedclinicians had immediate computer accessto up-to-date patient records acrosssystems. The creation of the netCAREportal required managers to consider themost efficient use of resources, how tosafeguard patient confidentiality and, inparticular, how to engage with the clini-cians who would ultimately use it. Withthe success of the netCARE portal, theAlberta Government has selected it as theplatform for a province-wide EHR.
At a hospital level, the University HealthNetwork (UHN), a large teaching hospitalon three sites in Toronto has successfullyimplemented CPOE (computerisedphysician order entry) including over50,000 medication orders a month – anapplication most hospitals in NorthAmerica have been unable to address atthis point in time. As a result, UHN hasbeen able to demonstrate a reduction inmedication errors and adverse drug events.
At a local level, patients at the GroupHealth Centre’s in Sault Ste. Marie,Ontario have been invited to participate inEMRxtra, a project supported by a $2million investment by Infoway. With thepatients’ consent, EMRxtra extends thecentre’s electronic medical records to localpharmacists and members of the larger,multi-disciplinary team of care providers.Access to lab results, allergies and othervital information contained in the elec-tronic medical record helps pharmacistsavoid dangerous drug interactions andprovide sound advice to the patient withthe confidence that comes from being fullyinformed about the patient’s medicalhistory. Just as importantly, the phar-macist’s expertise becomes an importantelement in the circle of care provided to thepatient.
The less good newsThe absence of additional funding in theGovernment of Canada’s 2008 Budget putsthe 2010 goal of providing 50% ofCanadians with an EHR at risk. Infowaywill need significant additional capital toprovide the benefits of EHRs to all Cana-dians and across the continuum of care asrecommended in the 2006 Health Councilof Canada Annual Report to Canadians.Two studies estimated the ten year totalcost of ownership for the pan-Canadianinteroperable EHRs at approximately $10billion, with a return of $6 to $7 billion ayear in efficiencies when fully imple-mented.2,3 An estimated investment of$350 per person, spread over ten years, isneeded. This is consistent with what otherdeveloped countries have invested.
In addition to the funding issue, a 2006study by the Commonwealth Fund foundthat only 23% per cent of Canadiandoctors use electronic medical records,compared with 98% in the Netherlands,92% in New Zealand and 89% in theUnited Kingdom.4 The seven-countrysurvey revealed strikingly differentcountry rates of primary care practice useof IT and the range of functions supported
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Table 1: Projects that have received Infoway Funding
Area Completed projects Active projects
Infostructure 14 10
Provincial client and provider registries 12 17
Provincial drug information systems 8 11
Provincial laboratory information systems 3 4
Regional diagnostic imaging systems 12 17
Telehealth 30 41
Public health surveillance 2 12
Interoperable EHRs 7 19
Innovation and adoption 9 26
Source: Canada Health Infoway, 2007.1
by office systems. Primary care doctors inAustralia, the Netherlands, New Zealandand the United Kingdom have the mostwidespread and multifunctional systems;Canadian and US doctors lag well behind.Some progress has been made since the2006 study, particularly in the province ofAlberta due to the government’s earlydecision to provide financial support to itsphysicians.
It seems a key problem is that the cost ofEMRs in a Canadian doctor’s office fallsmostly on the physician, while the benefitgoes to the health care system as a whole;this is especially true for the many singlehanded practices and small clinics that donot have the IT expertise to help themimplement and maintain technology. AJune 2007 survey identified lack ofwillpower and cost as the two reasons thataccount for approximately 80% of thebarriers to EMR adoption in the provinceof Ontario.
A further complication has been theprovincial governments’ inconsistent anddifferential approaches to EMR fundingwhich has de facto created two tier primarycare systems. Physicians who agree towork under particular funding formulashave their EMR costs covered by theprovince, whereas those doctors attachedto other funding schemes must draw fromtheir own resources in order to have EMRin their practice.
Another common problem in mostprovinces is ‘data stewardship’, i.e., whoshall keep the records and who shall ownthem. Ownership brings with it an expec-tation of granting privileges to others tocontribute to or gain access to the infor-mation. Concern about privacy and access(by both physicians and patients) seem tobe among the major reasons why Canadahas not adopted electronic records to thesame extent as many other countries have.Nevertheless, the CanadianMedical Asso-ciation believes that the benefits of elec-tronic records clearly outweigh the risks.As Flegel so aptly put it, “it has becomeclinically counterproductive to allow therisks to continue to delay the necessarydevelopment and implementation of tech-nologies. If we can handle the myriadprivacy concerns involved in electronicbanking, what is holding up electronicmedical records? We have the e-tech-nology; all we need is the e-will.”5
ConclusionAs strategic investor, Infoway has success-fully worked collaboratively with jurisdic-
tional partners to develop and share thelong-term health infostructure vision forCanada. They have facilitated nationalcollaboration to ensure that public andprivate sector stakeholders jointly plan,share best practices and continuallyimprove the deployment of the pan-Canadian health infostructure. Effectivealliances with the private sector havehelped Infoway better leverage itsinvestment dollars, and better align theinformation technology industry’sbusiness directions with their goals.Infoway’s emphasis on interoperabilityand vendor-neutral architecture andstandards generates interest from manypotential IT partners, and has allowedCanada’s health care jurisdictions toreduce costs and obtain upfront financingfrom vendors and suppliers.
To protect future investments, Infowayand the jurisdictions have implemented acollaborative risk assessment approachwhere project and jurisdiction risks areclearly identified for risk mitigation andreporting purposes. In addition, a QualityAssurance Framework was developed andwill be applied to all Infoway investmentprojects.
In closing, a 2007 Conference Board ofCanada study estimated that electronichealth record spending will have created37,000 new jobs by 2010, translating to $2billion in new labour income for Cana-dians.6 And every dollar invested byInfoway and the provinces adds $1.34 (onaverage) to Canada’s gross domesticproduct. More investment, exports andemployment bring more tax revenues forfederal and provincial governments –about $0.36 for each dollar invested. In
short, beyond better health care, allprovinces and territories are reapingeconomic benefits from their EHRprojects.
REFERENCES
1. EHRnews@Infoway. Spring/Summer2008. Montreal: Canada Health Infoway,2008. Available at http://www.infoway-inforoute.ca/Admin/Upload/Dev/Document/EHRNews_SS2008_EN.pdf
2. Booz Allen Hamilton. A 10-year Costand Benefits Analysis for Deploying a Pan-Canadian Electronic Health Record.Commissioned by Canada Health Infoway.March 2005.
3. Canada Health Infoway. The Evolutionof Health Care: Making a Difference.Canada Health Infoway Annual Report2007–2008. Montreal: Canada HealthInfoway, 2008. Available athttp://www.infoway-inforoute.ca/Admin/Upload/Dev/Document/Infoway_Annual_Report_2007-2008_Eng.pdf
4. Schoen C, Osborn R, Huynh P T, DotyM, Peugh J, Zapert K. On the front lines ofcare: primary care doctors’ office systems,experiences, and views in seven countries.Health Affairs 2006;25(6):w555–w571.
5. Flegel K. Getting to the electronicmedical record. Canadian MedicalAssociation Journal 2008;178(5):531.Available at http://www.cmaj.ca/cgi/content/full/178/5/531
6. Prada G, Santaguidar P. ExploringTechnological Innovation in HealthSystems. Ottawa: Conference Board ofCanada, 2007. Available athttp://sso.conferenceboard.ca/e-Library/LayoutAbstract.asp?DID=2098
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HEALTH POLICY DEVELOPMENTS
Taking a whole systemsapproach, the book:
• Analyses the prerequisitesfor effective policies forchronic care
• Examines systems for financing chronic care
• Describes the burden of chronic disease in Europe
• Explores the economic case for investing inchronic disease management
• Examines key challenges posed by the growingcomplexity in health care including prevention,the role of self-management, the health careworkforce, and decision support
Edited by Ellen Nolte andMartin McKee
Open University Press,December 2008, 265 pages
This new book systematicallyexamines some of the keyissues involved in the care ofthose with chronic diseases.
Taking an internationalperspective, it synthesisesthe evidence on what weknow works (or does not) indifferent circumstances.
NEW PUBLICATION
Caring for People with Chronic Conditions
BackgroundThe regulation of medicines in Europe islargely determined by EU legislation. As aconsequence, close collaboration has beenforged over recent decades between themedicine regulatory authorities inMemberStates, the European Commission and theEuropean Medicines Agency (EMEA).
There has also been a growing interest inenhancing the degree to which thecompetent health authorities exchangeinformation and share experience on abroad range of pharmaceutical policymatters.
This was a reason why ten years ago,European national competent authoritiesset up the Medical Evaluation Committee(MEDEV). The experiences of MEDEV todate are discussed in this snapshot article.
MEDEV is an expert group that meets onan informal basis and explores thepotential for collaboration in the field ofpharmaceutical policies and, in particular,with respect to the evaluation of medi-cines. It should be clear however that finaldecisions and possible negotiations(regarding price, certain restrictions onindications, who can prescribe) remain theresponsibility of each national competentauthority.
ObjectivesMEDEV collaborates on exchanginginformation and sharing experiencesamong European countries on pharmaceu-tical policies. The key objectives are to:
– Enhance possibilities for further collab-
oration among participating countrieson the evaluation of clinical researchand the cost-effectiveness of medicinesas criteria for reimbursement purposes.
– Promote possibilities for further collab-oration on the exchange of informationon drug prices and concrete steps formaking price information available onwebsites.
ActivitiesAn expert working group has been formedon clinical- and cost-effectiveness evalua-tions. It is a collaboration of the nationalcompetent pharmaceutical authorities thatare responsible for assessing (new)medicines for reimbursement and/or fordefinitions, pricing and reimbursementconditions. It meets on a regular basis (sixtimes a year) to discuss the evaluation ofnew medicines being considered forreimbursement.
Information on national reimbursementdecisions is shared between direct contactsand via the password-protected website.
Timing is of the utmost importance whensharing information, as reimbursementdecisions need to be made in relativelyshort time frames. Several countries maybe working simultaneously on theassessment of new medicines, so duringthat short period they should know whichof their counterparts is/are working on thesame dossier. On the other hand, othercountries may find themselves in thesecond wave of launch, so that they wouldbenefit from knowing in which countriesassessment has already taken place.
The key functions of MEDEV are set outin Box 1. MEDEV reviews existing guide-lines for assessing medicines for reim-bursement and explores possibilities forharmonising these guidelines, at least in thearea of clinical effectiveness. The groupalso discusses criteria for the re-assessmentof medicines for reimbursement in thelight of new information on clinicaleffectiveness and indications, sharesinformation on reviews of nationalreimbursement decisions and discusses
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Assessment for reimbursement:Collaboration at EU-level, the MEDEV-experiment
Ad Schuurman
Ad Schuurman is President of MEDEVand Head of the ReimbursementDepartment at the Dutch Health CareInsurance Board, Amsterdam, TheNetherlands.
1. Monitoring (new) drug assessments in all seventeen participating countries and exchanginginformation on current assessments.
2. Exploring and developing the methodology and criteria for assessing drugs for reimbursement.
3. Reviewing existing guidelines for assessing medicines for reimbursement and exploringpossibilities for harmonising guidelines, starting in the field of clinical effectiveness.
4. Discussing criteria for the re-assessment of medicines for reimbursement in the light of newinformation on clinical effectiveness and indications, and sharing information on the review ofnational reimbursement decisions.
5. Discussing criteria for therapeutic equivalence and inter-changeability.
6. Collaborating on post-listing reviews (for example, Vioxx, Celebrex) and adjusting indications.
7. Discussing arrangements for reference pricing and (therapeutic) clustering.
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EUROPEAN SNAPSHOTS
Social health insurance (SHI) schemes havebeen introduced in many countries of theformer Soviet Union as a means ofopening up the health sector to non-stateactors and opening up another stream offunding for health systems which had beendealing with decades of underfunding andfalling budgetary allocations. However,the introduction of SHI in countries of theformer Soviet Union has not generallybeen successful in increasing revenues forhealth funding, or improving transparency,access to services, or overall equity in thesystem.1 Historically, the introduction ofSHI as a complementary source of fundingfor the health system has not had aprofound impact on the high levels of outof pocket payments (OOPs) experiencedin some countries of the former SovietUnion, and financial protection in thesecountries remains weak.1
Nevertheless, in order to ensuresustainable financing for the health systemand as an equitable means of ensuringbroad access to health services for thepopulation, the Government of Moldovaintroduced a SHI scheme on 1 January2004.2 The more recent introduction ofSHI in Moldova would appear to haveavoided some pitfalls, and evidence is nowindicating that the introduction of SHI hasbeen successful in increasing funding forthe health system, providing financial riskpooling, as well as reducing OOPs forpoorer households and, thereby, improvingaccess to services and equity.2 In this article
the successes of the Moldovan experienceare elaborated and areas where furtherdevelopments are needed are highlighted.
Out-of-pocket paymentsAccording to World Health Organization(WHO) data, OOPs as a proportion oftotal health expenditure in Moldovapeaked in 2000 at 50.5%.3 Such highOOPs were a significant barrier to servicesfor the poorest households and an indi-cator of serious inequities.4 Formal usercharges had been introduced in 1999 inorder to tackle chronic underfunding inthe system and to aid transparency. Priorto this informal payments for services hadbecome widespread and it was hoped thatby ‘formalising’ these payments, issuessuch as differential pricing according tostaff estimates of how much a specificpatient could afford, could be addressed.5
However, formalising payments did littleto reduce the overall cost to patients and itdid not address the inequity of the systemor provide a financial risk poolingmechanism to protect households fromcatastrophic health costs.2
Formal co-payments were included as apart of the SHI package for certainservices, and OOPs as a share of totalhealth expenditure did fall from 45.8% in2003 to 41.4% following the introductionof SHI in 2004, although creeping up to42.9% in 2005. However, the structure ofout-of-pocket payments has changedmuch more significantly, as costs for theuninsured are significantly higher than forthe insured. On average in 2005, forexample, the cost of hospitalisation forinsured patients was 83% lower than foruninsured patients.6 This means that manyof the poorest households now have betterprotection from catastrophic health costs
criteria for therapeutic equivalence andinter-changeability. Confidentiality ofinformation is a pertinent concern.
At the moment MEDEV is preparing twopilot studies and will start providinggeneral, informal advice to two smallcompanies producing new orphan drugs.This will include scientific advice, as wellas information on procedures andadequate assessment dossiers. If possible,MEDEVwill do an (informal) assessment.Small pharmaceutical companies inparticular have problems submitting theirnew drugs to the twenty-seven differentreimbursement authorities in the EU. Thismodel could also prove relevant for largerfirms.
All of the above represents a pragmatic,informal way for MEDEV to develop aperspective on general, adequate assess-ments. To date MEDEV has succeeded inperforming thirty such assessments;national authorities can then at theirdiscretion make use of these assessmentsin accordance with the subsidiarityprinciple.
ConclusionThe MEDEV experiment demonstratesthat it is possible to cooperate successfullyon the assessment on medicines forreimbursement at an EU-level. The resultsof the informal assessments can be used indecision making at the level of MemberStates in accordance with the subsidiarityprinciple.
Critical is the fact that participants are notforced to work together, but rather it iseffective because it facilitates collegialcooperation between individuals workingon the same job: the scientific assessmentand pricing of medicines. In such a way wecan learn from each other, exchange infor-mation, methods and develop a commonframework. Potentially the benefits ofthese activities may also accrue to otherstakeholders including both the pharma-ceutical industry and patients.
Moldova:Using social health insurance toreduce out-of-pocket paymentsand improve equity
Erica Richardson
Erica Richardson is Research Officer,European Observatory on Health Systemsand Policies and Research Fellow, LondonSchool of Hygiene and Tropical Medicine.
as the non-working population is coveredby government contributions to the SHIscheme.
SHI in MoldovaSHI was first introduced on paper in 1998,but was not possible to implement at thetime due to severe fiscal difficulties facedby the Moldovan government. However,this break between the introduction ofSHI and actual implementation allowedthe government time to learn from theproblems faced in other countries whichhad Semashko systems but had introducedSHI. The new system was eventuallyintroduced nationwide on 1 January 2004.
In Moldova, the introduction of SHIinvolved the recentralising of healthfinancing to the independent non-profitNational Health Insurance Company(NHIC) rather than the introduction ofcompeting funds. This helped to ‘re-inte-grate’ financial pooling. The NHICcontracts with public and private healthservice providers, where possible on acompetitive basis, to purchase healthservices covered under SHI. Generaltaxation revenues cover a limited numberof basic services as part of a universalpackage of benefits. All other services,including those for the uninsured, arepurchased out of pocket.
Payroll contributions from the workingpopulation were set at 2% of wages forboth employees and employers. Althougha 2% reduction in income tax helped tooffset the cost for employees, the overalltax burden in Moldova is high so thebenefits of this were not necessarily felt bythe working population. The self-employed are responsible for paying theirown contributions at a fixed rate.However, there is cause for concern asmost of those considered self-employedare engaged in subsistence farming, mostdo not pay their contributions and areconsequently not covered under SHI.2
Significantly, government contributionspaid on behalf of the non-working popu-lation are equivalent to contributions fromthe working population and both arelinked to real costs. This is important as ithas ensured that health care funding covershealth care costs. An inadequategovernment contribution on behalf of thenon-working population is one reasonwhy the introduction of SHI has not beenas successful in providing equitable coverand reducing OOPs in other countries.1
The more accurate reflection of real costsin the pricing of services paid for by the
NHIC reduces pressure on serviceproviders to ‘make up’ funding shortfallsby charging patients informally. It has alsomeant an increase in both health careexpenditure as a percentage of GrossDomestic Product (GDP) and as a share oftotal health expenditure from publicsources.
The balance of public and private expen-diture on health has shifted. According toWHO estimates, in 2003, 51% of totalhealth expenditure came from publicsources, but this jumped to 56.8% in 2004,falling to 55.5% in 2005. Overall, totalhealth expenditure as a proportion of GDPhas also risen significantly since theintroduction of SHI; according to WHOestimates, from 6.8% in 2003 to 7.4% in2004 and 7.5% in 2005.3 Total healthexpenditure in terms of purchasing powerparity reached its nadir in 1999 at $71 percapita and, although still low by regionalstandards, it grew to $170 per capita in2005.3
Future challengesCoverage of the rural ‘self-employed’ poorpopulation needs to be improved to allowthe working poor to benefit from SHI.This is currently the main challenge toequity in the Moldovan health system, aspaying full costs for health care out ofpocket is a significant barrier to accessinghealth services not covered by the limiteduniversal package. Estimates of coveragelevels also need to be more sensitive toensure the poorest rural regions are not leftwith the least funding for services.Currently, in providing funding forservices, the NHIC assumes that 20% ofthe population are uninsured. However, in2004, 24.3% of the population were unin-sured and there were significant regionalvariations – from 58% in the rural Cahulregion to 85% in Chisinau municipality.2
More generally, the main out-of-pocketcost to patients is pharmaceuticals, veryfew of which are covered either by thestate-funded universal package or SHIcontributions. Following the introductionof SHI in 2004, spending on pharmaceu-ticals from private, as opposed to publicsources, fell to 63.3%, however theproportion has since returned to a higherlevel, 79.9% in 2005 and 79.5% in 2006.3
Therefore it is necessary to graduallyincrease the number of products coveredby SHI and reduce the OOP burden forpharmaceutical spending; although thisneeds to be achieved without jeopardisingcurrent fiscal successes.
ConclusionsThe main lesson that could be learnt fromtheMoldovan experience is that SHI is nota cheap option for governments; in orderto reduce OOPs and improve financialprotection for the population, it isnecessary to increase pre-payment forservices. If the system is going to functionadequately, there needs to be equivalencebetween contributions from the centralbudget for the non-working populationand payroll contributions from theworking population.
The credibility of the system rests on itsability to actually fund the services itpurports to cover. Therefore, it isimportant that allocations from the third-party payer do indeed cover costs to theservice provider, so there is less need tomake up the difference by chargingpatients directly. However, it is alsoimportant to review the benefits packagecovered by SHI, in order to ensure thatimportant aspects of the health system thatare not covered do not act as a barrier toaccessing care and thus threaten equity inthe system.
REFERENCES
1. Preker AS, Jakab M, Schneider M.Health financing reforms in central andeastern Europe and the former SovietUnion. In: Mossialos E, Dixon A, FiguerasJ, Kutzin J (eds). Funding Health Care:Options for Europe. Buckingham: OpenUniversity Press, 2002.
2. Atun R, Richardson E, Shiskhin S,Kacevicius G, Ciocani M, Sava V. Healthsystems in transition: Moldova. HealthSystems in Transition 2008:10(5).
3. World Health Organization RegionalOffice for Europe. European Health forAll Database. Copenhagen: World HealthOrganization Regional Office for Europe,2008.
4. World Bank. Moldova Health PolicyNote: The Health Sector in Transition.Washington D.C: World Bank, 2003.
5. Allin S, Davaki K, Mossialos E. Payingfor ‘free’ health care: the conundrum ofinformal payments in post-communistEurope. In: Global Corruption Report2006: Corruption and Health. Berlin:Transparency International, 2006.
6. Shishkin S, Kacevicius G, Ciocanu M.Evaluation of Health Financing Reform inthe Republic of Moldova. Copenhagen:WHO Regional Office for Europe, 2006.
Eurohealth Vol 14 No 335
EUROPEAN SNAPSHOTS
Eurohealth Vol 14 No 3 36
Risk inPerspective
BackgroundWhile many studies have reported adverseresponses to ozone, a highly oxidising gas,reports that ozone exposure might hastendeaths have been more recent. The firstlarge-scale report came from Europe,where seven cities were studied using iden-tical methods and the results combined.1
Studies from Europe during that period(the 1990s) have the advantage that use ofair conditioning was quite low. Openwindows ensure that day-to-day changesin outdoor ozone concentrations are morehighly correlated with day-to-day changesin personal exposure, and hence reduceexposure error. This may limit generalis-ability to North America, however. Sincethen a number of studies have reportedsimilar results, including three large meta-analyses commissioned by the UnitedStates Environmental Protection Agency(EPA).2–4 Moreover, a large multi-citystudy has found no evidence of a thresholddown to very low levels.5
The implications of these findings forozone risk assessment are enormous. Incost-benefit analyses of air pollutants,mortality risks, whenmonetised, dominatethe benefit calculation. Because of this, aNational Academy of Sciences committeewas commissioned to review the evidence.Its report, recently issued, concluded thatthe evidence for a mortality association is
strong.6 Among the questions raised to thecommittee are those in the introduction.These address the potential forconfounding (i.e., that other exposuresmay actually be responsible for theobserved association), as well as questionsabout who is being affected that haveimportance for health impact assessmentsand benefit analyses. Because of the criticalrole these might play in estimating anappropriate level for the standard, we havebeen active in addressing these issues. Arecent Risk in Perspective article (RIP) hasfocused on the valuation issue, which ofcourse generalises to other exposures.7
This RIP will focus on results addressingthe other questions.
Are the ozone-associated deaths due toother exposures?The major concern of observationalepidemiology studies is that some otherexposure, correlated with the exposure ofinterest, may explain the observed associ-ation, which is not causal but due to thatcorrelation. To confound studies of shortterm changes in ozone and daily deaths,such confounders must co-vary withozone over the same timescale. There aretwo obvious candidates for such aconfounder – temperature and othersecondary pollutants.
Are the ozone-associated deaths due tothe association of ozone with hightemperature?
Ozone is not directly emitted by pollutingsources. It is produced by chemical reac-tions in the atmosphere between nitrogenoxides and volatile organic compounds(VOCs), and those reactions are driven bysunlight and temperature. Hence ozoneco-varies with temperature. All studies ofthe effect of ozone on daily deaths have
Joel Schwartz
This article is reproduced with permissionand was first published as Risk inPerspective Volume 16, Number 2 by theHarvard Center for Risk Analysis in July2008. Peer reviewer: Michelle Bell.
Harvard Center for Risk Analysis,Harvard School of Public Health,Landmark Center, 401 Park Drive,PO Box 15677, Boston,Massachusetts, 02215 USA.The full series is available atwww.hcra.harvard.edu
OZONE ANDMORTALITY – AN UPDATE
While it has long been accepted that ozone can produce morbidity, as clearlydemonstrated in chamber studies, the evidence that ozone kills people is rela-tively new, and more controversial. In particular, a number of questions havebeen raised that are central to translating that literature into risk assessment andbenefit analyses. Is the ozone-associated mortality just short-term mortalitydisplacement? Does risk vary by individual? If so, what characteristics define theat-risk individual? Are the associations confounded by temperature? By othersecondary air pollutants? How are any early deaths associated with ozoneexposure to be valued? Recent work by Harvard Center for Risk Analysis facultyand staff has addressed these questions, and is summarised below.
therefore controlled for temperature.However, the association of temperaturewith death is highly non-linear, with heatwave conditions associated with muchlarger increases in deaths than tempera-tures just a few degrees cooler. How canwe be sure that those studies correctlycaptured that relation, and that the ozoneassociation is not due to ozone capturingthe remaining effect of temperature?
I addressed this in an analysis of over onemillion deaths in fourteen cities.7 Ratherthan examine the correlation between dailyozone and daily deaths, I converted theanalysis into a case-control study. Using avariant called case-crossover analysis, Imatched each decedent with him orherself, on a control day in the samemonthof the same year that they died, which alsohad the same temperature (rounded to thesame degree). This matching controlled forseason and time trend, by choosing acontrol day in the same month and year asthe date of death, and since the temper-ature was the same on the control day asthe case day, it could not explain which daythe death occurred on. I then compared theozone levels on the two days to see if theypredicted which day was the date of death.I found the same association with ozonethat I found analysing the data using themore traditional time series analysis. Thisindicates that confounding by temperatureis unlikely to explain the observed ozonemortality association.
Are the ozone-associated deaths due toother secondary pollutants?
The same processes, chemical reactionsdriven by light and heat, that produceozone also produce other secondary pollu-tants (secondary because they are notdirectly emitted). Among these aresulphate particles, from the reaction ofsulphur oxides with ammonia, nitrateparticles, from the reaction of nitrogenoxides with ammonia, and organicparticles, which like ozone derive fromreactions of hydrocarbons. In addition,other gaseous pollutants, such as peroxy-acetylnitrate (PAN), are produced by thesame type of reactions that produce ozone.These pollutants are rarely measured, andhence previous studies have not controlledfor them. To the extent that the controlmeasures adopted to reduce ozone, such asreductions in emissions of nitrogen oxides
and hydrocarbons, also reduce these othersecondary pollutants, such as PAN, it maynot be critical for policy analysis to distin-guish among them. However, all strategiesdo not reduce these secondary pollutantsequally, and secondary sulphate particleswould be reduced by a completelydifferent strategy, the control of sulphuroxide emissions. Hence this is a keyremaining uncertainty.
To address this, Franklin and Schwartzturned to the EPA’s speciation* moni-toring network.8 Unfortunately, thisnetwork which has only been operatingsince 2000, usually monitors only one inthree or one in six days, and only measuresparticles and not other oxidant gases.Nevertheless, using data from eighteencities with speciated particle measure-ments, we showed that control for nitrateparticles or organic carbon particles didnot change the estimated effect of ozoneon mortality. In contrast, control forsulphate particles reduced the estimatedozone effect by about 25%, although theconfidence interval in that estimate waswide, and included the possibility of nochange in the ozone effect. Hence some ofthe effect attributed by past studies toozone may have been due to sulphateparticles, but organic and nitrate particlesdo not appear to be confounders.
Are the ozone-associated deathsadvanced by only a small amount?One possible explanation of the observedassociations is that they are causal, but thatonly extremely sensitive individuals, whoare on the brink of death, are affected bythis exposure. If ozone is merely bringingforward deaths among people who wouldhave died in the next week anyway, thepublic health impact of the observed ozonemortality association is much reduced.Recently, we addressed this question in alarge, multi-city study.
To understand this question, it is useful toconsider the schematic below. In it, weimagine that there is a pool of persons whoare highly susceptible to dying in the short
run. This could, for example, includepeople with severe pneumonia, or withacute inflammations that have decreasedthe stability of atherosclerotic plaques thatare temporarily at much higher thannormal risk of rupturing and producing aheart attack. Individuals in this high-riskpool can recover and return to a morenormal risk, or they can die. Each daysome die, some recover, and some newpeople enter the high-risk pool. Concep-tually, air pollution might affect all threetransition rates. If air pollution onlyincreased the rate of dying out of the pool,then we would expect the pool to bedepleted by an ozone episode, resulting infewer deaths in the next week. In this case,the deaths associated with ozone exposureare only being brought forward by a shortperiod. However, if ozone affects therecruitment rate, the size of the pool couldactually increase, and excess deaths couldcontinue well after the ozone episodeoccurred.
If ozone’s primary effect is on the deathrate from the risk pool and deaths wereonly being brought forward by, forexample, seven days, then, ceteris paribus,we would expect a negative correlationbetween ozone exposure today and deathsa week from now. Zanobetti and Schwartzused this insight to look at the correlationbetween ozone levels and death counts inforty-eight US cities for time periods up totwenty-one days after exposure.9
They found that there was no negativecorrelation between ozone and mortalityup to twenty-one days later, and that thepositive association persisted over severaldays but fell to zero within a few days. Theoverall effect of ozone over the period wasan increase of 0.5% in daily deaths(95%C.I.: 0.05–0.96) per 10 parts perbillion (ppb) increase in eight hour averageozone, compared with an increase of 0.3%(95%C.I.: 0.2–0.4) when deaths on onlyone day were considered. Hence the deathsassociated with ozone are not just beingbrought forward by a few weeks, andprevious studies may have underestimated
Eurohealth Vol 14 No 337
EVIDENCE-INFORMED DECISIONMAKING
Generalpopulation
Riskpool
DeathT1
T2
T3
* Speciation analysis is the identificationand/or measurement of the quantities ofone or more individual chemical ‘species’ ina sample.
the overall effect of ozone on mortality byjust considering the effect of the ozone ondeaths the same day.
Who is susceptible to the effects ofozone?The question of who is dying on high-ozone days affects many areas of riskassessment and health policy analysis. Thepresence of chronic conditions or the ageof the individuals at risk may affect thebenefit values associated with delaying theozone-associated deaths. In addition, sincethe age pyramid and prevalence of certainconditions are changing in the UnitedStates and elsewhere, understanding of therelative risks in different subpopulationswill be important. To address this, weconducted a case-only study. A case-onlystudy is focused on identifying factors thatmodify risk, and does not examine whatthe baseline risk is. It is based on thefollowing idea. Suppose some personalcharacteristic, for example diabetes,modifies the risk of dying on a high airpollution day. Then one would expect, onaverage, more of the deaths on high-ozonedays to be among diabetics than the deathson low-ozone days. Therefore, one can testthis hypothesis (greater susceptibility ofdiabetics to ozone) by doing a regressionon the people who died over a period ofyears, with the outcome whether or notthey were diabetic, and the predictor theozone concentrations on the day they died.This approach has the advantage thatthings that only predict whether or not aperson died are not confounders in thisanalysis, since they don’t predict theoutcome (diabetes, not deaths).10,11
Our analysis examined 2.7 million deathsin forty-eight cities between 1989 and2000.12 We found, as expected, increasedsusceptibility among people aged sixty-fiveand older (~2.7 fold higher percentageincrease in deaths per 10 ppb of ozone).More interestingly, the black populationhad roughly 1.8 times the percentageincrease in deaths as the non-black popu-lation, and women over the age of sixtyhad about 1.9 times the percentage increase in death as men. Below age sixty,however, there was no difference betweenthe risk in men and women, suggestingsome protection by hormonal status.Among chronic diseases, atrial fibrillationwas associated with 1.7 times thepercentage increase in deaths per 10ppb ofozone. Previous studies have suggestedthat atrial fibrillation also increased the riskof dying on very hot days,13 or as a resultof particle exposure.14
Analyses of mortality data are limited tolooking at modifying factors that areshown on the death certificate. Exami-nation of other potential markers ofsusceptibility requires other techniques.One approach is to look at a surrogateoutcome. Lung function is a continuousoutcome which is highly predictive ofmortality rate. We examined the short termassociation between ozone and decrementsin lung function (forced expiratory volumein 1 second, FEV1) in a cohort of elderlymen in the Boston area. We found thatozone was associated with reduced FEV1,but that the effect was larger in obesesubjects.15 Since obesity is a growingproblem all over the world, this suggeststhat in the absence of contravening changesin other risk modifiers, the susceptiblepool may grow over time.
ConclusionsWhile uncertainties still remain, a signif-icant fraction of the questions have beenresolved. The ozone-associated deaths donot appear to be short-term mortalitydisplacement and aggregate effects overseveral days may increase the risk esti-mates. There may be some confounding bysulphate particles, but not by othersecondary particles. This may reduce therisk estimates. Most of the ozone-associated deaths are in the elderly, but thedifferences by race and sex may beimportant. Major chronic diseases such aschronic obstructive pulmonary disease(COPD) and diabetes that provide signif-icant reductions in quality of life are notmodifiers of the ozone-association.However, while diabetes is not a modifier,obesity may be. Given trends in obesityover time, this will also be relevant for riskassessments.
REFERENCES
1. Touloumi G, Katsouyanni K, ZmirouD, et al. Short-term effects of ambientoxidant exposure on mortality: acombined analysis within the APHEAproject. Air pollution and health: aEuropean approach. Am J Epidemiol1997;146(2):177–85.
2. Bell ML, Dominici F, Samet JM. Ameta-analysis of time-series studies ofozone and mortality with comparison tothe national morbidity, mortality, and airpollution study. Epidemiology2005;16(4):436–45.
3. Levy JI, Chemerynski SM, Sarnat JA.Ozone exposure and mortality: anempiric bayesian metaregression analysis.
Epidemiology 2005;16(4):458–68.
4. Ito K, De Leon SF, Lippmann M.Associations between ozone and dailymortality: analysis and meta-analysis.Epidemiology 2005;16(4):446–57.
5. Bell ML, Peng RD, Dominici F. Theexposure-response curve for ozone andrisk of mortality and the adequacy ofcurrent ozone regulations. EnvironHealth Perspect 2006;114(4):532–36.
6. National Research Council. EstimatingMortality Risk Reduction and EconomicBenefits from Controlling Ozone AirPollution. Washington, DC: NationalAcademies Press, 2008.
7. Hammitt J. Valuing “lives saved” vs.“life-years saved.” Risk in Perspective2008;16 (1):1–5.
8. Schwartz J. How sensitive is theassociation between ozone and dailydeaths to control for temperature? Am JRespir Crit Care Med 2005;171(6):627–31.
9. Franklin M, Schwartz J. The impact ofsecondary particles on the associationbetween ambient ozone and mortality.Environ Health Perspect 2008;116(4):453–58.
10. Zanobetti A, Schwartz J. Mortalitydisplacement in the association of ozonewith mortality: an analysis of 48 cities inthe United States. Am J Respir Crit CareMed 2008;177(2):184–89.
11. Schwartz J. Who is sensitive toextremes of temperature? A case-onlyanalysis. Epidemiology 2005;16(1):67–72.
12. Armstrong B. Fixed factors thatmodify the effects of time-varying factors:applying the case-only approach.Epidemiology 2003;14(4):467–72.
13. Medina-Ramon M, Schwartz J. Whois more vulnerable to die from ozone airpollution? Epidemiology 2008;19(5):672–79.
14. Medina-Ramon M, Zanobetti A,Cavanagh DP, Schwartz J. Extremetemperatures and mortality: assessingeffect modification by personal character-istics and specific cause of death in amulti-city case-only analysis. EnvironHealth Perspect 2006;114(9):1331–36.
15. Zeka A, Zanobetti A, Schwartz J.Individual-level modifiers of the effects ofparticulate matter on daily mortality. AmJ Epidemiol 2006;163(9):849–59.
16. Alexeeff SE, Litonjua AA, Suh H,Sparrow D, Vokonas PS, Schwartz J.Ozone exposure and lung function: effectmodified by obesity and airways hyper-responsiveness in the VA normative agingstudy. Chest 2007;132(6):1890–97.
Eurohealth Vol 14 No 3 38
EVIDENCE-INFORMED DECISIONMAKING
We know that many people do not takemedicines prescribed for them, and thatadherence rates are often low.We also knowthat older people have problems with theirmedicines, often because they are prescribedmany medicines, to be taken at differenttimes of the day. Finally, we know thatmajor influences on admission to hospitalwith adverse drug reactions include olderage, being a woman and having lots oftablets to take.
It does not need a brain the size of the planetto see that there are some problems here
needing to be solved. A trial from the USA1
suggests that extremely good adherenceresults can be had from some simple inter-ventions from pharmacists that help olderpeople understand and manage their medi-cines.
TrialThis is an interesting example of arandomised withdrawal trial design outlinedin Figure 1.
1. All patients entered a two month run-inperiod used to ascertain baselineadherence and measure blood pressureand cholesterol.
2. After this, all patients entered an inter-vention phase, during which theyreceived their drugs individualised inblister packs with tablets labelled for timeof day. This was supplemented with indi-vidualised education visits, and follow upwith a pharmacist every two months.These visits taught patients about theirdrugs, their names and indication,strengths, adverse events and usageinstructions.
3. After six months, patients wererandomised to continuing the inter-vention or usual care.
Adherence, blood pressure, and cholesterolwere measured during the run-in period andat the end of each six-month period.
ResultsInitially, 200 patients entered the run-inperiod and 159 were eventually randomised.Their average age was 78 years (minimum 65years), 77% were men, 57% had four ormore health problems, with an average ofnine chronic medications. There were highlevels of use of statins and blood pressuremedicines.
Results for adherence are shown in Table 1.The pharmacy care programme resulted ina large increase in adherence, with theproportion of patients more than 80%adherent to all medicines increasing from
Eurohealth Vol 14 No 339
Pharmacy care in older patients
Evidence-basedhealth care
Bandolier is an online journal about evidence-based healthcare, written by Oxfordscientists. Articles can be accessed at www.jr2.ox.ac.uk/bandolier
Table 1: Median adherence (% of all tablets taken) and percentage of patients taking at least80% of all medicines
Run-in InterventionRandomised to
Usual care Intervention
Month 2 8 14 14
Median adherence (%) 62 99 68 96
>80% adherence to allmedicines
5 99 22 97
Figure 1: Randomised withdrawal design of study of pharmacy care in older patients withmultiple health problems
Eurohealth Vol 14 No 3 40
EVIDENCE-INFORMED DECISIONMAKING
just 5% in the run-in period to 99%. Afterrandomisation, the intervention groupmaintained these high levels of adherence,while return to usual care resulted in alarge decrease in adherence, approachingrates seen in the run-in period.
Increased adherence resulted in largereductions in systolic and diastolic bloodpressure during the intervention period;for LDL (low density lipoprotein) choles-terol useful reductions in both groupswere maintained after randomisation, withno significant difference between them.
CommentThis is a very important study, whichshows that to achieve high adherence inolder people with multiple healthproblems and medications continuingintervention is needed. The paper, andespecially the thoughtful discussion,should be read by anyone wanting to dobetter.
The benefits of high adherence are poten-tially large, given the generally lowadherence usually seen in these circum-stances, and given that low adherence isassociated with increased rates of hospitaladmission. This is not a simple answer to asimple problem, but an indication thatwith insightful pragmatic action muchbetter outcomes can result.
After all, the pills are better in the patientthan in a bottle. If the latter we pay twice,in unused medicine and more health carecosts. Given the acknowledged size of theproblem, the implication is that this is atopic area that requires some sensibleresearch and action.
REFERENCE
1. Lee JK, Grace KA, Taylor AJ. Effect ofa pharmacy care program on medicationadherence and persistence, blood pressure,and low-density lipoprotein cholesterol. Arandomized controlled trial. Journal of theAmerican Medical Association 2006 296:2563–71.
A new series of policy briefs on health systems and healthpolicy issues was launched at the WHO European MinisterialConference on Health System held in Tallinn, Estonia in June2008. A joint project between the Health Evidence Networkand the European Observatory on Health Systems andPolicies, this new series aims to meet policy-makers’requirements in two ways. First, it presents a rigorousreview of the available research evidence, and second, thebriefs are written in a language accessible to non-specialistpolicy-makers and follow a consistent format.
Appropriateness and implementation are key considerationsfor the series. Countries have different requirements anddemands and a given policy option is unlikely to be relevantor appropriate to all systems and approaches. As such, thebriefs do not aim to provide an ideal ‘model’ or recom-mended approach. Instead, they cover and synthesiseavailable research evidence and potential policy options forbest practice, such that policy makers can consider meansand strategies towards innovating in their respectivesystems.
The briefs bring together key evidence underlining thecentral themes of the Conference: health and wealth, publichealth, governance, coordinated care, human resources, andfinancing. Given the focus of the Conference, the underlyingconcern of all the briefs was to improve health systemperformance.
Nine joint policy briefs have been published:
� How can European health systems support investment inand the implementation of population health strategies?
� How can the impact of health technology assessments beenhanced?
� Where are the patients in decision making about theirown care?
� How can the settings used to provide care to olderpeople be balanced?
� When do vertical (stand-alone) programmes have a placein health systems?
� How can chronic disease management programmesoperate across care settings and providers?
� How can the migration of health service professionals bemanaged so as to reduce any negative effects on supply?
� How can optimal skill mix be effectively implementedand why?
� Do lifelong learning and revalidation ensure thatphysicians are fit to practice?
The briefs are available in English, French, German andRussian athttp://www.euro.who.int/HEN/policybriefs/20080814_2
New series of policy briefs launched atWHO European Ministerial Conference‘Health Systems, Health and Wealth’
Eurohealth Vol 14 No 341
NEW PUBLICATIONSEurohealth aims to provide information on new publications that may be ofinterest to readers. Contact Sherry Merkur at [email protected] if you wishto submit a publication for potential inclusion in a future issue.
Health for all? A critical analysis ofpublic health policies in eightEuropean countries
Edited by Christer Hogstedt, HenrikMoberg, Bernt Lundgren and MonaBackhans
ISBN 978-91-7257-572-1
358 pages
Freely available online at:http://www.fhi.se/shop/material_pdf/R200821_Health_for_all0808komp.pdf
This study compares the evolution ofnational public health policies in eightEuropean countries with attention to theircharacter and contents concerning socialand lifestyle determinants; the involvementof non-health sectors (for example,education, labour market, environment);and experiences with different strategies. Adetailed literature review is also presentedon comparative studies of policies on healthinequalities.
For each country, the public health situ-ation is examined by a local expert makinguse of a comprehensive template. Findingsinclude: development of society and thepresent policy environment; magnitude,trends and analysis regarding socialinequalities in health; public health
strategies focusing on specific health deter-minants; disease-specific strategies; group-specific strategies; arena approaches;implementation methods, resources andmain actors; as well as monitoring and eval-uation. Also considered are behavioural riskfactors and measures taken to tacklelifestyle factors, such as tobacco, alcoholand overweight.
The ultimate objective of this study was toidentify common experiences, notabledifferences and lessons. One of the mainfindings of the publication is that “the wayhealth inequalities are explained is closelyrelated to the way they are dealt with, i.e.to what extent governments try to makepeople behave differently or attempt tochange their living conditions.”
Closing the gap in a generation:Health equity through action on thesocial determinants of health
Commission on Social Determinants ofHealth
Geneva: World Health Organization,2008
ISBN 978 92 4 156370 3
247 pages
Freely available at:http://www.who.int/social_determinants/final_report/en/index.html
Many of the differences in health betweenand within countries result from the socialenvironment where people are born, live,grow, work and age. These so-called ‘socialdeterminants of health’ have been the focusof a WHO Commission established in2005, which aimed to marshal evidence andmake recommendations on reducing healthinequities. Their final report was publishedin August 2008.
The report goes beyond measuring healthinequities between countries, and docu-ments ‘health gradients’ within countries aswell, for example, by showing differencesin life expectancy and maternal mortalityfor different cultural groups within thesame country. On the topic of health andwealth, the report shows that wealth alonedoes not have to determine the health of anation’s population. Some low-incomecountries such as Cuba, Costa Rica, China,
the state of Kerala in India and Sri Lankahave achieved levels of good health despiterelatively low national incomes.
The Chair of the Commission, Sir MichaelMarmot, commented that an “effective wayof increasing life expectancy and improvinghealth would be for every governmentpolicy and programme to be assessed for itsimpact on health and health equity”. Thereport cites the Nordic countries asproviding outstanding policies that haveencouraged equality of benefits andservices, full employment, gender equityand low levels of social exclusion, thatshould be adopted everywhere.
The full report in English and the executivesummary in six UN languages, along withsupporting press release, country examples,figures, tables and graphs and podcast areavailable for download.
Contents:Foreword; Contributors; Comparative Studies of Policies on Health Inequalities –A Literature Review; Health Inequities – Concepts, Measures and Pathways;Denmark; England; Finland; Italy; The Netherlands; Norway; Spain; Sweden;Summary Chapter; Concluding Remarks and Recommendations.
Contents:Executive Summary; Setting the Scene for a Global Approach to Health Quality;Evidence, Action, Actors; Daily Living Conditions; Power, Money andResources; Knowledge, Monitoring and Skills; Building a Global Movement;List of Recommendations.
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Please contact Philipa Mladovsky [email protected] to suggest web sites
for potential inclusion in future issues.
Baltic Sea Network onOccupational Health andSafety (BSN)
http://www.balticseaosh.net
DETERMINE
http://www.health-inequalities.eu
Northern DimensionPartnership in Public Healthand Social Well-being(NDPHS)
http://www.ndphs.org
DETERMINE is an EU consortium for action on socioeconomic determinants of health. It hosts anEnglish-language European Portal for Action on Health Equity. This contains: country healthinequality profiles; a database of good practices; an EU Policy Section with case studies; a health inall 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; andpublications.
The aim of the Foresight Project on Mental Capital and Wellbeing has been to advise the UKgovernment on how to achieve the best possible mental development and mental wellbeing foreveryone in the future. The Project has collated high quality scientific evidence and involved thecollaboration of a large number of expert advisors. The recently launched final report, as well as alarge number of background documents, CD ROMs, and an article published in Nature, can befreely accessed at the English language web site. Topics include analysis of future challenges formental health, as well as the complex relationship between wellbeing and work.
European MonitoringCentre for Drugs andDrug Addiction(EMCDDA)
http://www.emcdda.europa.eu
EMCDDA is one of the European Union’s decentralised agencies. Established in 1993 and based inLisbon, it is the central source of comprehensive information on drugs and drug addiction inEurope. Most of the web site’s content is in English but some pages are available in twenty-fourEuropean languages. It provides drug related statistics, as well as country profiles, information onEU law on drugs, news and publications. Evidence for policy is available in a ‘best practice portal’.
The NDPHS brings together thirteen governments, the European Commission and eight interna-tional organisations, to focus on northern Europe. The English, Polish and Russian language web siteprovides information about events, an e-newsletter, and presentations. It also provides access to thework of expert groups on HIV/AIDS, prison health, primary health care, social inclusion, healthylifestyles and work ability. An online database contains information on projects, papers and contacts.It also contains a ‘project pipeline’, a multi-agency on-line project funding coordination tool.
The BSN brings together occupational health and safety institutions from all the countriesbordering the Baltic Sea, ranging from Norway to Russia. The site contains a modest amount ofinformation including the annual workplan, meeting reports, contact information for participants,links to other occupational health and safety organisations, as well as access to relevant reportsstored in the NDPHS database.
Eurosafe
http://www.ecosa.org
The English-language web site of the European Association for Injury Prevention and SafetyPromotion (Eurosafe) contains information on various activities including the consumer safetyprogramme, EU Injury database and European Child Safety Alliance. It also contains the archives ofEurosafe Alert, the organisation’s regular newsletter, including a special edition on the recent 2ndEuropean 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.
WEBwatch
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EUROPEAN MONITOR
WHO Commission: Inequitieskilling people on a “grandscale”The final report of the WHOCommission on the Social Deter-minants of Health Closing theGap in a Generation: HealthEquity through Action on theSocial Determinants of Healthwas published on 28 August inGeneva. The report is the resultof a three-year investigation byan eminent group of policymakers, academics, former headsof state and former ministers ofhealth.
Stark findings include the obser-vation that children born in aGlasgow suburb can expect a lifetwenty-eight years shorter thanthose living only thirteen kilo-metres away, while a girl inLesotho is likely to live forty-two years less than another inJapan. In Sweden, the risk of awoman dying during pregnancyand childbirth is one in 17,400; inAfghanistan, the odds are one ineight. Biology does not explainany of this. Instead, the differ-ences between – and within –countries result from the socialenvironment where people areborn, live, grow, work and age.“(The) toxic combination of badpolicies, economics, and politicsis, in large measure responsiblefor the fact that a majority ofpeople in the world do not enjoythe good health that is biologi-cally possible…Social injustice iskilling people on a grand scale.”
“Health inequity really is amatter of life and death,” saidWHO Director-General DrMargaret Chan while welcomingthe report and congratulating theCommission. “But healthsystems will not naturally grav-itate towards equity. Unprece-dented leadership is needed thatcompels all actors, includingthose beyond the health sector, toexamine their impact on health.Primary health care, whichintegrates health in all ofgovernment’s policies, is the bestframework for doing so.”
Commission Chair, Sir MichaelMarmot, said that “central to theCommission’s recommendationsis creating the conditions forpeople to be empowered, to havefreedom to lead flourishing lives.Nowhere is lack of empow-erment more obvious than in theplight of women in many parts ofthe world. Health suffers as aresult. Following our recommen-dations would dramaticallyimprove the health and lifechances of billions of people.”
The Commission found evidencethat demonstrates, in general,that the poor are worse off thanthose less deprived. They alsofound that the less deprived are inturn worse than those withaverage incomes, and so on. Thisslope linking income and healthis the social gradient, and is seeneverywhere – not just in devel-oping countries, but in all coun-tries, including the richest. Theslope may be more or less steepin different countries, but thephenomenon is universal.
Wealth is not necessarily adeterminant
Economic growth is raisingincomes in many countries butincreasing national wealth alonedoes not necessarily increasenational health. Without equi-table distribution of benefits,national growth can even exac-erbate inequities.
While there has been anenormous increase in globalwealth, technology and livingstandards in recent years, the keyquestion is how it is used for fairdistribution of services and insti-tution-building, especially inlow-income countries. In 1980,the richest countries with 10% ofthe world’s population had agross national income sixty timesthat of the poorest countries with10% of the population. Aftertwenty-five years of globali-sation, this difference hasincreased to 122.. Worse, in thelast fifteen years, the poorestquintile in many low-incomecountries have shown a decliningshare in national consumption.
Wealth alone does not have to
determine the health of a nation’spopulation. Some low-incomecountries such as Cuba, CostaRica, China, the state of Kerala inIndia and Sri Lanka haveachieved levels of good healthdespite relatively low nationalincomes. But, the Commissionpoints out, wealth can be wiselyused. Nordic countries, forexample, have followed policiesthat encouraged equality ofbenefits and services, fullemployment, gender equity andlow levels of social exclusion.This, said the Commission, is anoutstanding example of whatneeds to be done everywhere.
Solutions from beyond thehealth sector
Much of the work to redresshealth inequities lies beyond thehealth sector. According to theCommission’s report, “Water-borne diseases are not caused bya lack of antibiotics but by dirtywater, and by the political, social,and economic forces that fail tomake clean water available to all;heart disease is caused not by alack of coronary care units but bylives people lead, which areshaped by the environments inwhich they live; obesity is notcaused by moral failure on thepart of individuals but by theexcess availability of high-fat andhigh-sugar foods.” The healthsector – globally and nationally –needs to focus attention onaddressing the root causes ofinequities in health.
“We rely too much on medicalinterventions as a way ofincreasing life expectancy”explained Sir Michael. “A moreeffective way of increasing lifeexpectancy and improving healthwould be for every governmentpolicy and programme to beassessed for its impact on healthand health equity; to make healthand health equity a marker forgovernment performance.”
Recommendations
Based on this compellingevidence, the Commission makesthree overarching recommenda-tions to tackle the “corrosiveeffects of inequality of life
chances”. First, to improve daily livingconditions, including the circumstances inwhich people are born, grow, live, workand age. Measures recommended includeinvestment in early childhood servicesand fairer access to health care services.Second, measures to tackle the inequitabledistribution of power, money andresources globally, nationally and locally.Finally, they recognise the importance ofmonitoring the situation and assessing theimpact of intervention.
Acknowledging the challenge of imple-mentation, the Commission noted that,on the basis of a commitment to makeprogress on the social determinants ofhealth equity, there are now nine countrypartners, including Sweden and the UK.WHO will make the report available toMember States which will determine howthe health agency is to respond.
The report is available athttp://www.who.int/entity/social_determinants/final_report/en/index.html
World Health Report calls for a return toprimary health care approachOn 14 October 2008 in Almaty, Kaza-khstan, the World Health Report 2008Primary Health Care – Now More ThanEverwas launched. The launch commem-orates the 30th anniversary of the Alma-Ata International Conference on PrimaryHealth Care held in 1978. That event wasthe first to put health equity on the inter-national political agenda.
The report critically assesses the way thathealth care is organised, financed anddelivered in rich and poor countriesaround the world. It documents a numberof failures and shortcomings that have leftthe health status of different populations,both within and between countries,dangerously out of balance.
Speaking at the launch, WHO DirectorGeneral Dr Margaret Chan said that “theWorld Health Report sets out a way totackle inequities and inefficiencies inhealth care, and its recommendations needto be heeded,” adding that “a world that isgreatly out of balance in matters of healthis neither stable nor secure.”
In a wide-ranging review, the reportfound striking inequities in healthoutcomes, in access to care, and in whatpeople have to pay for care. Differences inlife expectancy between the richest andpoorest countries now exceed forty years.Of the estimated 136 million women whowill give birth this year, around fifty-eight
million will receive no medical assistancewhatsoever during childbirth and thepostpartum period, endangering theirlives and that of their infants.
Globally, annual government expenditureon health varies from as little as US$ 20per person to well over US$ 6,000. For 5.6billion people in low- and middle-incomecountries, more than half of all health careexpenditure is through out-of-pocketpayments. With the costs of health carerising and systems for financial protectionin disarray, personal expenditures onhealth now push more than 100 millionpeople below the poverty line each year.
Data in the report are also indicates a situ-ation in which many health systems havelost their focus on fair access to care, theirability to invest resources wisely, and theircapacity to meet the needs and expecta-tions of people, especially in impover-ished and marginalised groups. As thereport notes, conditions of “inequitableaccess, impoverishing costs, and erosionof trust in health care constitute a threatto social stability.”
To steer health systems towards betterperformance, the report calls for a returnto primary health care, a holistic approachto health care formally launched thirtyyears ago. When countries at the samelevel of economic development arecompared, those where health care isorganised around the tenets of primaryhealth care produce a higher level of heathfor the same investment.
It notes that in far too many cases, peoplewho are well-off and generally healthierhave the best access to the best care, whilethe poor are left to fend for themselves.Health care is often delivered accordingto a model that concentrates on diseases,high technology, and specialist care, withhealth viewed as a product of biomedicalinterventions and the power of preventionlargely ignored.
Specialists may perform tasks that arebetter managed by general practitioners,family doctors, or nurses. Thiscontributes to inefficiency, restricts access,and deprives patients of opportunities forcomprehensive care. When health isskewered towards specialist care, a broadmenu of protective and preventive inter-ventions tends to be lost.
The report is available athttp://www.who.int/entity/whr/2008/en/index.html
Commission acts on excessive workingtime in GreeceOn 16 October 2008, the EuropeanCommission sent a letter of formal noticeto Greece for failure to comply with EUrules on maximum working time asregards doctors in public health services.Vladimír Špidla, EU Commissioner forEmployment and Social Affairs, said thatthe “Working Time Directive protectsworkers from being forced to workexcessive hours, which can endanger theirhealth and could increase risks for others.The Commission must act when it isconcerned that minimum standards arenot being adhered to.”
The Directive (2003/88/EC) limitsworking time to 48 hours per week onaverage. The Commission has receivednumerous complaints that Greece hassuspended some of its working time lawsso doctors in public hospitals can belegally required to work excessive hours.The complaints state that specialistdoctors are being obliged to work anaverage of 60–72 hours per week, withdoctors in training obliged to work anaverage of 71–93 hours per week. Theyalso suggest that minimum rest periods arenot being respected, with doctors requiredto work up to 32 continuous hours. TheDirective stipulates that a worker isentitled to eleven hours a day of rest andone full day off a week. It should be notedthat Greece does not make use of theoption to derogate from the 48 hour week.
The Greek authorities now have twomonths to reply. If further compliancewith EU legislation is needed, theCommission can send a reasoned opinion,and again Greece would have a furthertwo months to reply. Ultimately, if thereis no satisfactory reply, the Commissioncan refer the matter to the EuropeanCourt of Justice in Luxembourg. It canalso request that the Court impose a fineon the country if it does not comply.
The Working Time Directive is itselfcurrently being revised under the co-decision procedure. The CommonPosition, adopted by the Council in June,is now before the European Parliament.Furthermore, the Commission iscurrently finalising a detailed report onthe implementation of the Working TimeDirective in all Member States. It isplanned for adoption in December 2008.
Further information athttp://ec.europa.eu/employment_social/labour_law/index_en.htm
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‘Europe for Patients’ campaignOn 30 September, Health CommissionerAndroulla Vassiliou launched the ‘Europefor Patients’ campaign in Brussels. Thecampaign highlights the different healthpolicy initiatives the Commission intendsto adopt in the coming six to nine months.All the initiatives are bound by a commongoal: better health care for all in Europe.They address patient safety, rare diseases,organ donation and transplantation,cancer screening, the health workforce,influenza and childhood vaccination andantibiotic use. The first initiative, on crossborder health care, was adopted by theCommission in July. In launching thecampaign the Commissioner stressed theneed to increase awareness across the EUof the many positive impacts of EU healthpolicies. She stated that “we need toprovide clear information, free of Euro-jargon with real examples that relate topeople’s lives.”
A webpage on the EU Health Portal intwenty-two languages will become aninformation hub where documents,articles and events will be posted.http://health.europa.eu/efp
Legal instruments underpinning EU’smedical device directives adoptedIn February 2007, the EuropeanCommission proposed a new package ofmeasures which were intended to boostintra-community trade in industrial goods(the ‘new approach system’). Thesemeasures were designed to ensure that theinternal market became a reality for allmanufacturers and producers, and tomake it easier for companies, especiallymedium sized enterprises, to trade theirproducts in the EU. On 23 June 2008, theEuropean Council finally adopted thisnew package of measures. At the sametime it adopted measures dealing with the‘mutual recognition principle’ thatcompliments the ‘new approach system’.
The principle of free movement of goodsis one of the cornerstones of the ECTreaty. Many industrial products arealready subject to Community legislationand so can be traded freely within the EU.However, free trade must go hand-in-hand with high safety standards. The ‘newapproach system’ strengthens theframework within which the goods aremanufactured and traded, building uponexisting mechanisms, to ensure that onlysafe products circulate. Market surveil-lance structures will be strengthened tocatch unsafe products, to remove them
from the whole Community market andto take action against manufacturers. Thetesting, certification and inspection bodiesthat are involved in product checking willbe subject to more stringent controls inthe form of accreditation, to ensure thatthere is a level playing field both formanufacturers and the inspection bodies.
Not all goods fall under Communitylegislation. Many companies have foundit difficult to sell their products in otherMember States, and are discouraged fromventuring outside their domestic marketdue to the burden of proving that theirproducts fulfilled the technical require-ments in the destination Member State.Recognising this problem, the aim behindthe ‘mutual recognition principle’ is thatMember States will be prevented fromstopping the sale of goods which havebeen lawfully marketed in anotherMember State.
EU Drugs Action Plan for 2009–2012On 18 September 2008, the Commissionadopted an ‘EU Drugs Action Plan’ forthe period 2009–2012. The plan comes ata time when the latest available data fromthe European Commission show thatwhereas the use of heroin, cannabis andsynthetic drugs has stabilised or isdeclining, cocaine use is rising in anumber of Member States. The totalnumber of people in the EU who usedrugs – or have at some time taken them– is estimated at seventy million forcannabis, at least twelve million forcocaine, more than nine million forecstasy and eleven million for ampheta-mines, while at least half a million peopleare known to be receiving substitutiontreatment for heroin. There are up to twomillion problem drug users in the EU andaround 7,500 people die of drug over-doses each year.
The new Action Plan builds on theexisting approach of the EU DrugsStrategy 2005–2012 which set out aEuropean model for drug policy based ona balanced approach to reduce bothsupply and demand for drugs. The fivemain priorities of the new Action Planare: reducing the demand for drugs andraising public awareness, mobilisingEuropean citizens, reducing the supply ofdrugs, improving international co-operation and facilitating a better under-standing of the drug phenomenon.
Actions proposed include measures toimprove the quality, availability andcoverage of treatment and harm reduction
programmes for drug users and the estab-lishment of intelligence-led police andcustoms operations to counter large-scaleorganised crime groups both in the EUand on the drug trafficking routes fromAfghanistan and Latin America.
The Action Plan 2009–2012 will bepresented to the Council and is expectedto be adopted before the end of the year.
More information athttp://ec.europa.eu/justice_home/fsj/drugs/fsj_drugs_intro_en.htm
COUNTRY NEWS
Swedish focus on suicide preventionOn 14 July it was reported that theSwedish government had decided to makesuicide prevention a priority in therecently updated public health bill. Theaim is that no one should find themselvesin a situation where they see taking theirown life as the only way out.
Each year, about 1,400 people take theirown life in Sweden, which is about twiceas many lives lost as a result of traffic acci-dents. Suicide is the most common causeof death among people aged 15–44, albeitmost suicides are committed by peoplethe aged over of 45. Preliminary estimatesfor 2007 indicate that 17.3 per 100,000men and 6.9 per 100,000 women diedfrom suicide.
Given that many suicides are avoidable,the government decided on three schemesto help reduce intentional deaths. The firsttargets young people. The SwedishNational Institute of Public Health(SNIPH), the Swedish National Agencyfor School Improvement and the NationalSuicide and Mental Ill-health PreventionUnit at the Karolinska Institute have beengiven the task of producing informationmaterial on suicide prevention and astrategy for disseminating the material toteachers and school employees.
The second scheme targets health carepersonnel and other professionals, such aspolice and criminal justice systempersonnel, whomay come in contact withpeople at risk of suicide. The SNIPH andthe National Board of Health andWelfarewill propose ways in which to furthereducate such professionals in suicideprevention strategies.
In the third scheme, the government aimsto improve public awareness of suicideprevention. The National Board of
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Health and Welfare will produce thisinformation, as well as a strategy fordissemination in cooperation with otherorganisations.
UNICEF boosts funding to help ensureproper nutrition for Kyrgyz childrenThe United Nations Children’s Fund(UNICEF) will provide $270,000 in addi-tional funds to help develop a nationalnutrition strategy in Kyrgyzstan, wheremore than half of babies and infants areanaemic and many young children sufferfrom stunted growth as a result ofnutrient deficiencies.
“Giving a child a solid nutritional start inlife is critical to physical, mental and socialdevelopment,” stressed UNICEF chiefAnn Veneman during her visit to theCentral Asian nation, the first-ever by anExecutive Director of the agency. Whilein the capital, Bishkek, Ms Veneman alsovisited the Rehabilitation Centre forStreet Children, which provides shelterfor some seventy children who have beenexposed to violence, exploitation orabuse. She held talks with Prime MinisterIgor Chudinov on a range of issues,including the implementation of legis-lation to protect the country’s children, aswell as the recent establishment of thenew government department to co-ordinate children’s issues.
More than half of the population inKyrgyzstan – the second poorest countryin Eastern Europe and Central Asia – livesin poverty and more than one quarter inextreme poverty, affecting more than 60%of children under the age of fourteen.Statistics show that at least 50% ofKyrgyz babies aged between 6–24 monthsare anaemic and nearly 14% of childrenunder five suffer from stunted growth.
UNICEF has been supporting activitiesin the country since 1994 in areas such ashealth and nutrition, clean water and sani-tation, quality basic education for all boysand girls, as well as the rights of margin-alised children, children in poverty andchildren facing discrimination.
More information athttp://www.un.org/apps/news/story.asp?NewsID=28608&Cr=KYRGYZ&Cr1=
Russia: TB poses security threat inRussia, official saysTuberculosis (TB) poses a threat toRussia’s security and labour force,Mikhail Grishankov, first deputy chair ofthe security committee of the State Duma,
said during a roundtable at the WorldBank office on 22 September in Moscow.Grishankov added that the Russiangovernment plans to allocate twenty-sixbillion Russian roubles, or about $1billion, from 2007 to 2011 for a TBprevention and treatment programme.
According to Grishankov, “social infec-tions” such as TB and HIV “pose a realthreat” to Russia’s security because theyoften affect people during their primeworking years, at a time when the countryis experiencing a labour shortage. Inaddition, drug resistant TB is increasingin Russia and requires more expensivetreatment than drug-sensitive strains ofthe disease. Treatment for drug-sensitiveTB costs 2,500 roubles, or about $99, forsix months, compared with 1.5 millionroubles, or about $60,000, for one year totreat drug-resistant TB.
Grishankov recommended thatgovernment branches work together tocontrol TB in Russia, noting that “poorawareness of authorities and people is themain obstacle to development of an up-to-date comprehensive inter-agencyprogramme”.
Most TB patients in Russia are classifiedas ‘socially vulnerable’, including peoplewho are alcoholics, homeless, migrants orunemployed. More than 300,000 TB caseshave been registered in Russia, which hasa TB incidence of more than 100 cases per100,000 people in twenty six regions.Nearby countries such as Finland,Norway and Sweden have a TB incidenceof five to six cases per 100,000 people.According to the WHO, Russia ranks11th out of the twenty two countries withthe highest TB burden worldwide andaccounts for 35% of all primary TB casesin WHO’s European region.
More information athttp://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=54604
France: experts discuss integration of TBservices within primary careTuberculosis experts discussed the inte-gration of TB services into primary healthcare and global progress in TB control atthe ‘Stop TB Partnership’ symposium atthe 39th Union World Conference onLungHealth on 16 October in Paris. NilsBillo, executive director of the Interna-tional Union Against Tuberculosis andLung Disease, said that despite the devel-opment of stronger health systems andbetter TB control in developing countries
over the last two decades, there still is a“long way” to go.
According to Billo, inadequate funding,insufficient management of DOTS, anincrease in multi-drug resistant (MDR)TB and extensively drug-resistant (XDR)TB, and a lack of infrastructure in devel-oping countries to address MDR- andXDR-TB are presenting challenges inmeeting the United Nations’ MillenniumDevelopment Goals and the Global PlanTo Stop TB: 2006–2015 targets. Billocalled on France, Germany, the UK andthe US to increase efforts to address TBworldwide, saying they should “launch amajor financial rescue plan for TB.”
Marcos Espinal, executive secretary of theStop TB Partnership, said that drug-resistant TB, HIV/TB co-infections and alack of infrastructure are hindering healthsystems’ efforts to control TB. MarioRaviglione, director of the Stop TBDepartment at the WHO, said that theglobal TB community needs to work“urgently” to improve health systems indeveloping countries, adding that globaltargets on TB control cannot be metwithout improvement in developingcountries’ health infrastructures.Raviglione called for increased funding,noting that although concerns about theglobal economy likely will affect TBfunding, the global health communitymust still increase efforts to link TBservices with health systems in developingcountries.
The conference also heard that whilemany of the twenty-two countries withthe highest TB burden worldwide havemade progress in detecting and treatingnew cases, continued progress will requirecoordination from entire health systems,including better integration into primaryhealth care.
More information at http://www.kaiser-network.org/daily_reports/rep_index.cfm?DR_ID=55041
UK: Government action to fund gaps inhealth researchA new £5 million research programmewhich is intended to lead to an increase inservice quality and patient safety throughbetter ways of planning and providinghealth services was announced on 15October by Public HealthMinister DawnPrimarolo, during a visit to Southampton.
The newHealth Services Research (HSR)programme will provide funding acrossthe country for a broader range of health
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services research than is already coveredby the National Institute for HealthResearch (NIHR) programmes: theEfficacy & Mechanism EvaluationProgramme, the Health TechnologyAssessment Programme, the ServiceDelivery & Organisation Programme,Programme Grants for Applied Researchand the Research for Patient BenefitProgramme. These are all specialist sub-sets in the field of health services research,which means that some projects may bedifficult to fund as they fall outside estab-lished NIHR funding streams, as well asthose covered by the Medical ResearchCouncil and the Department of Health.
The HSR programme will fund researchmainly through a researcher-led work-stream, whereby grants are provided forboth primary and evidence synthesis ontopics proposed directly by researchers,on an ongoing basis. The programmemayalso advertise calls for research proposalson specific topics. Dawn Primarolo said“health services research producesknowledge that can lead to theimprovement of health policy, healthsystems, and health care delivery, ulti-mately resulting in improvements inpopulation health. This area of researchhas already made a valuable contributionto the improvement of health and healthcare in the UK.With this new programmewe are taking action to fund importantresearch where there is currently no alter-native source of funding.”
The Government recognised the impor-tance of health services research in itsnational health research strategy ‘BestResearch for Best Health’, where one ofthe strategic goals is to commissionresearch focused on improving health andcare. The Cooksey review also high-lighted the need for increased funding forresearch into the implementation of newproducts and approaches into practice.
Commenting on the launch of theprogramme Professor Sally C Davies,Director General of Research & Devel-opment at the Department of Health saidthat “all types of study designs appro-priate to health services research will besupported, which include both primaryresearch and evidence syntheses. Ourearly work with stakeholders has high-lighted a number of key areas likely to beof interest to this new programme. Theseinclude cultural and organisational issuesaround patient safety, making better useof existing research knowledge throughmodelling, and the use of existing health
data to improve the planning and deliveryof health services and systems.”
The first call for expressions of interestwill be taking place in January 2009.
More information and details on how toregister at http://www.hsr.nihr.ac.uk
UK: Almost one fifth of MPs haveexperienced mental health problems.The All-Party Parliamentary Group onMental Health has found that 86%thought being an MP was stressful. Thereport criticises the law forcing MPs togive up their seats for life if they areplaced into institutional care for sixmonths under the Mental Health Act. Nosuch rules apply to MPs who are physi-cally incapable of working for the sametime period.
Joint chairman Sandra Gidley said workon ‘challenging stigma’ was needed. Someninety-four MPs took part in the survey.One in three said colleagues’ attitudes andthe possibility of a hostile media reactionprevented openness about mental healthissues. Ms Gidley, a Liberal DemocratMP, said that “greater openness at West-minster about mental health problemswould have a significant impact in chal-lenging stigma and discrimination”.
She pointed to the experiences of formerNorwegian Prime Minister’ Kjell MagneBondevik, who publicly disclosed that heneeded to take time off work because ofdepression. She noted that his popularitywas unaffected and indeed “he went on tobe re-elected and prove that people whohave experienced mental health problemscan recover and manage a challengingjob.”
Paul Farmer, chief executive of the charityMind, commenting on the survey saidthat “at a time when the government isappealing to employers to be more under-standing about mental health issues aspart of its aim to get people off benefitsand back into workplace, it seems theyshould be looking to take action closer tohome. Repealing antiquated rules that banMPs from returning to work after recov-ering from a mental health problemwould send out a clear message to allemployers that discrimination should notbe tolerated.”
Similarly the charity Rethink’s chief exec-utive, Paul Jenkins, said that the findingswere “an affront to democracy. MPs andpeers need to be free to bring theirpersonal experiences to their vital demo-
cratic role. Instead they are being gaggedby the prejudice, ignorance and fearsurrounding mental illness. We lookforward to the day when MPs from allpolitical parties with experience of mentalillness are able to participate fully in ourdemocracy.”
More information on the survey can beaccessed at http://www.lynnejones.org.uk/survey%20FINAL.pdf
Channel Islanders could lose somerights to free health care in the UKChannel Islanders who fall ill or haveaccidents in the UK could soon be leftwith huge medical bills if they do not havetravel insurance. The necessity to take outcomprehensive insurance is likely to beone consequence of the UK’s Departmentof Health intention to withdraw from thereciprocal health agreement with theChannel Islands of Jersey and Guernsey,as well as other off-shore jurisdictions,including the Isle of Man and Gibraltar.
At the moment, islanders travelling to theUK, and UK residents who visit theChannel Islands are entitled to emergencyhealth care that is free at the point ofdelivery. Jersey’s health minister BenShenton said that the matter was stillunder negotiation, and insisted that he didnot think that any change in the currentagreement was imminent.
Under Jersey’s reciprocal agreement,which was established more than fortyyears ago, the island pays the UK forservices it uses in England, and theDepartment of Health hands over cash tocover the cost of emergency treatment forUK residents visiting Jersey. Thetaxpayers of both places ultimately payfor the services used, but they are free atthe point of delivery for patients.
The Department of Health’s positionfurther strains relations between Jerseyand Westminster. In recent months theconstitutional status quo has come intosharp focus as a result of the historicalchild abuse inquiry, and calls for the UKto step in to ensure that the court processis fair to victims and those accused ofabuse. Whatever changes will be intro-duced, the UK has made it clear thatChannel Island residents currentlystudying in the UK will be treated as UKcitizens for the purposes of their healthcare needs.
More information at http://www.gov.je/Health/who_we_are/Channel+IslandsReciprocalHealthAgreement.htm
Eurohealth Vol 14 No 347
MONITOR
Summit promotes joint commitmentto improve inclusion for millions ofRomaOn 16 September in Brussels the Euro-pean Commission launched the firstEU-level summit devoted to improvingthe situation of Roma communitiesacross the Union. Discrimination againstRoma people persists and 77% ofEuropeans think that being Roma is adisadvantage in Europe. In the SocialAgenda of 2 July 2008, the Commissionset out a renewed commitment to non-discrimination in general and action toimprove the situation of Roma in partic-ular. It concluded that there is a power-ful framework of legislative, financialand policy coordination tools availableat EU level and that these are increas-ingly used, but that there is still animplementation gap in the MemberStates. The Summit forms the next stepin this process and aims to support andpromote a joint commitment by theMember States, the EU institutions andcivil society. The conclusions will feedinto discussions at the December 2008European Council.
More information athttp://ec.europa.eu/employment_social/fundamental_rights/roma/index_en.htm
Progress in preventing injuries in theWHO European RegionA new publication by D Sethi,F Racioppi, B Frerick and N Frempongfrom the WHO European Centre forEnvironment and Health in Rome,looks at the progress achieved by Mem-ber States on injury prevention. It re-ports on the development of web-basedtools comprising a database of countryprofiles compiled through a question-naire survey and an inventory of na-tional policies. Good progress is takingplace, with the development of nationalpolicies for individual types of injuryand violence varying from 86% for roadsafety to about 33% for the preventionof youth and self-inflicted violence. Thereport notes that the health sector needsto commit to more widespread imple-mentation of effective programmes bothin number and coverage and to engagewith other stakeholders in a multi-sectoral response to prevent injuries.
The report is available at http://www.euro.who.int/document/E91710.pdf
Updated Global Burden of DiseaseOn 27 October the World Health Or-ganization published a new assessmentof the global burden of disease, a studythat provides a comprehensive picture ofthe global and regional state of health.Drawing from extensive data, it featurescomparisons between deaths, diseasesand injuries by region, age, sex andcountry income for the year 2004. It alsoprovides projections of deaths and bur-den of disease by cause and region to theyear 2030. The study contains details ofthe top ten causes of death and estimatesfor over 130 disease and injury causes.
More information at http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/index.html
Improving cost-effectiveness in thehealth care sector in IcelandA new OECD working paper byHannes Suppanz argues that the highcosts of health care provision in Icelandmight be addressed by removing imped-iments to private provision and openingup the health sector to competition. Itsuggests that introduction of cost shar-ing where it does not exist (as in hospi-tals) might be considered, althoughconcerns about equity need to be takeninto account. This it is argued would re-lieve the burden on public finances, aswould the introduction of spending ceil-ings, cost-efficiency analysis and activ-ity-based funding arrangements. Thehigh cost of pharmaceuticals might alsobe reduced by promoting competitionand the use of inexpensive generic drugs.
The working paper is available athttp://www.olis.oecd.org/olis/2008doc.nsf/LinkTo/NT00005C72/$FILE/JT03253001.PDF
EU warns of permanent hearingdamage from iPods
Listening to personal music players at ahigh volume over a sustained period canlead to permanent hearing damage,according to an opinion of the EUScientific Committee on Emerging andNewly Identified Health Risks. Thescientific opinion shows 5–10% of thosewho listen to a personal music player formore than one hour per day each weekat high volume for at least five years riskpermanent hearing loss. In response, EUConsumer Affairs Commissioner
Meglena Kuneva said that “we need toraise consumer awareness and put thisinformation in the public domain. Weneed also to look again at the controls inplace, in the light of this scientific ad-vice, to make sure they are fully effectiveand keep pace with new technology.”The Commission will hold a conferencein early 2009 in Brussels to evaluate theScientific Committee’s findings withMember States, industry, consumers andother stakeholders and to discuss theway forward. The seminar will addressprecautions that users can take, as wellas technical solutions to minimisehearing damage and the need for furtherregulations or revisions of existing safetystandards to protect consumers.
More information is available athttp://ec.europa.eu/health/opinions/en/hearing-loss-personal-music-player-mp3
Report on inequalities in youngpeople’s healthA new report from the Health Behav-iour in School-aged Children: WHOCollaborative Cross-National Studypresents key findings on patterns ofhealth among young people in forty-onecountries and regions across Europe andNorth America. This report has a specialfocus on health inequalities and indicatesthat, while the health and well-being ofmany young people are cause for cele-bration, sizeable minorities are experi-encing real and worrying problemsrelated to overweight and obesity,self-esteem, life satisfaction, substancemisuse and bullying. It concludes thatpolicy makers and professionals shouldlisten closely to the voices of youngpeople and ensure that these drive ef-forts to put in place the circumstances –social, economic, health and educational– within which young people can thriveand prosper.
The report can be downloaded athttp://www.euro.who.int/InformationSources/Publications/Catalogue/20080616_1
eurohealth Vol 14 No 3 52
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