EurohealthVolume 14 Number 4, 2008RESEARCH • DEBATE • POLICY • NEWS

Spain: mental health reform • Turkey: health care and pharmaceutical policy • Health governance in FranceFinland: welfare state meets consumer society • Czech Republic: First steps on path to reform

Liberalisation of mentalhealth care in the

Netherlands

Engagement with Russiain the health sector

Devolution and healthpolicy in the UK

Another piece of the puzzle:Commission perspectives onpharmaceutical innovation

LSE Health, London School of Economics and PoliticalScience, Houghton Street, LondonWC2A 2AE, United Kingdomfax: +44 (0)20 7955 6090http://www.lse.ac.uk/collections/LSEHealth

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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, Norway, Slovenia, Spain and Sweden, the VenetoRegion of Italy, the European Investment Bank, the WorldBank, the London School of Economics and PoliticalScience, and the London School of Hygiene & TropicalMedicine.

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Putting the pieces of the puzzlein place

Implementing health policy can sometimes feel liketrying to complete a highly intricate jigsaw. Manyjigsaw pieces look similar, but each one can only fit inone unique place in the puzzle. One constant challengeis how to square the need for investment inpharmaceutical innovation and research with the acuteneed to contain costs during a time of severe financialconstraints. Yet at the same time facilitating a positiveenvironment for research can enhance Europe’scompetitiveness, potentially protecting jobs, byhelping the pharmaceutical sector remain dynamic.

We are thus especially delighted to feature twoEuropean Commission perspectives on these issues.European Commissioner for Health, AndroullaVassiliou, sets out an encouraging overview ofachievements to date, albeit acknowledging that manychallenges lie ahead. Georgette Lalis, Director, DGEnterprise and Industry, reflects on three parts of thepuzzle posed by pharmaceutical innovation: patientsafety; availability, access and affordability ofmedicines; and transparency in the disclosure ofinformation. Meeting these challenges will now formmuch of the focus of the so-called ‘Pharma Package’,adopted by the Commission in December.

Among other contributions we feature an USperspective from Edward Burger and E. Wayne Merryon opportunities for better engagement andcollaboration with Russia in the health sector. Theyfirmly put an emphasis on the need not to rush intoaction but instead to spend more time listening andlearning from Russian practitioners and policymakers.

Reforms continue apace across Europe. Yetremarkably, there has been all too little discussion ofthe natural experiment arising from a decade of healthsystem devolution in the UK. Here Scott Greer givesus an insight into the resultant divergences in policythat have emerged; many have resonance elsewhere.Other articles include one on general health systemreform in Turkey, as well as two on recent reforms tothe mental health sectors in Spain and the Netherlands.It is to be hoped that all the contributions to this issueof Eurohealth can help us to put a few more pieces ofthe puzzle in place.

David McDaid EditorSherry Merkur Deputy EditorPhilipa MladovskyDeputy Editor

MENT

EurohealthCOM

Contents EurohealthVolume 14 Number 4

Jordi Alonso is based at the Health Services ResearchUnit, Institut Municipal d’Investigació Mèdica (IMIM-Hospital del Mar), Barcelona, Spain.

Edward J Burger is Director, Eurasian MedicalEducation Programme of the American College ofPhysicians, Washington D.C., USA.

Juan Cabases Hita is Professor of Applied Economics,Universidad Pública de Navarra, Spain.

Joan Costa-Font is Senior Research Fellow andLecturer, LSE Health, London School of Economics andPolitical Science, UK.

Scott Greer is Assistant Professor of HealthManagement and Policy, University of MichiganSchool of Public Health, Ann Arbor, Michigan, USA.

Ineke Kok is Head of the Department of Mental HealthCare Policy and Management at the Trimbos Institute,Utrecht, the Netherlands.

Lucia Kossarova is reading for a PhD, LSE Health,London School of Economics and Political Science, UK.

Georgette Lalis is Director, DG Enterprise and Industry,European Commission, Brussels, Belgium.

Henrieta Mad’arová is an advisor on health insurancereform to Czech Minister of Health and a member ofReforma zdravotnictvi-forum, Czech Republic.

Gregory P Marchildon is Canada Research Chair inPublic Policy and Economic History, Johnson-ShoyamaGraduate School of Public Policy, University of Regina,Saskatchewan, Canada.

David McDaid is Senior Research Fellow, LSE Healthand Social Care and European Observatory on HealthSystems and Policies, London School of Economics andPolitical Science, UK.

E Wayne Merry is Senior Associate, American ForeignPolicy Council, Washington D.C., USA.

Zeynep Or is Senior Research Fellow at the Institute forResearch and Information in Health Economics(IRDES), Paris, France.

Omer Saka is Health Economist, Division of Healthand Social Care Research, King’s College, London.

Luis Salvador-Carulla is Professor in the Department ofPsychiatry, University of Cadiz, Spain.

Hannu Valtonen is Professor of Health Economics,Department of Health Policy and Management,University of Kuopio, Kuopio, Finland.

Frank van Hoof is Senior Research Associate,Department of Mental Health Care Policy andManagement at the Trimbos Institute, Utrecht, theNetherlands.

Nebibe Varol is reading for a PhD, LSE Health,London School of Economics and Political Science, UK.

Androulla Vassiliou is European Commissioner forHealth, European Commission, Brussels, Belgium.

Joost Vijselaar is Senior Research Associate at theTrimbos Institute and Professor of the History ofPsychiatry at the University of Utrecht,the Netherlands.

Perspectives from the Commission1 Research and innovation in pharmaceuticals: covering unmet needs

Androulla Vassiliou

3 Does fostering pharmaceutical innovation and competitivenessbenefit the European patient?Georgette Lalis

Mental Health Reform14 New and old challenges in the reform of mental health systems

in SpainJoan Costa-Font, Juan Cabases Hita, Jordi Alonso,Luis Salvador-Carulla and David McDaid

18 Liberalisation of health care in the Netherlands: the case ofmental health careFrank van Hoof, Ineke Kok and Joost Vijselaar

Health Policy Developments22 Devolution and health policy in the UK

Scott L Greer

25 Engagement with Russia – not isolation – in the health sectorEdward J Burger and E Wayne Merry

29 Health care and pharmaceutical policies in Turkey after 2003Nebibe Varol and Omer Saka

European Snapshots7 Changing regional health governance in France

Zeynep Or

8 Regionalisation reversal in CanadaGregory P Marchildon

10 Czech Republic: first steps on the path to health care reformLucia Kossarova and Henrieta Mad’arová

12 The Finnish welfare state meets the consumer societyHannu Valtonen

Evidence-informed Decision Making33 “Mythbuster” Generic drugs are lower quality and less safe than

brand name drugs

35 “Bandolier” Gout and drinking

Monitor37 Publications

38 Web Watch

39 News from around Europe

Eurohealth Vol 14 No 41

PERSPECTIVES FROM THE COMMISSION

The provision of the highest quality healthcare is an issue that requires coordinationand dialogue between us all, and I wouldlike to provide an overview of the achieve-ments made so far at a European Union(EU) level in the area of research and inno-vation from a public health perspective.

As you will know, we have to conduct avery delicate balancing act between highquality public health care, maintainingindustry competitiveness, and theprovision of cost containment policies.The EU believes in some basic commonvalues and principles for health care. Socialprotection should ensure that all citizenshave access to high quality care inde-pendent of their ability to pay. Hence, soli-darity and the fair distribution of resourcesare two key principles inherent to healthcare systems. Yet these principles do notalways today translate into universal accessto health care. There remain significantunmet health care needs, not only withinthe EU, but even more dramatically,worldwide.

New technologies could be part of thesolution. But if we are not careful, theycould also become part of the problem.Yes, they can help improve quality of life,but at the same time they can create anincreasingly difficult challenge for healthcare policy makers, as the issue of afford-ability inevitably arises when a new inno-vative product becomes available.

Threats to public healthExactly three years ago the World HealthOrganization (WHO) held a conference toreview implementation of the recommen-dations outlined in its report on PriorityMedicines for Europe and the World, aninitiative of the Dutch Presidency of theEU in 2004. The report identified a list ofpriority areas in threats to public health,such as HIV/AIDS, pandemic influenzaand antimicrobial resistance, which couldbe the focus of research and developmentin the field of pharmaceuticals, vaccinesand biologicals for Europe and the rest ofthe world.

I would like to expand on how the reporthas influenced the actions of the EuropeanCommission. One such example is theInnovativeMedicines Initiative (IMI). Thiswas launched in early 2008 with the objec-tives of supporting the faster discovery anddevelopment of better medicines forpatients, while enhancing Europe’scompetitiveness by ensuring that itsbiopharmaceutical sector remains adynamic high-technology sector.

It is a unique partnership between theEuropean Community, represented by theEuropean Commission, and the EuropeanFederation of Pharmaceutical Industriesand Associations. It has benefited fromtremendous financial input and willmanage €2 billion of funds from bothindustry and the EU’s Seventh ResearchFramework Programme.

One priority area for the EU is pandemicinfluenza. The threat of an outbreak ofpandemic influenza remains a very realconcern. In light of the enormous scale and

impact of such an event our responses andpreparedness planning needs to becomprehensive and involve all sectorsconcerned in a coordinated way. This isnot an easy task. The EuropeanCommission has responded by playing animportant role in helping Member Statesto improve EU-wide coordination ofprevention and control measures forinfluenza and other communicablediseases.

We are also closely working together withthe WHO, for example through a numberof workshops, to help Member Statesprepare for an influenza pandemic.Medical interventions will be a key pillarof defence. In respect of the developmentof new interventions I, of course, call onthe industry to be more active. After all, inrecent years many developed countrieshave increased their stockpiling, andconsiderable earnings have been realised.

The European Commission is also vigor-ously supporting research and action onpandemic influenza, both via the EUSeventh Framework Programme and theHealth Programme. The SeventhFramework Programme is the most signif-icant EU programme on research andinnovation. The current programme, witha budget in excess of €50 billion, runs from2007 to 2013.

In line with the priorities of the WHOreport, the EU is also aiming to implementspecific strategies to contain antimicrobialresistance. Through the EU Public HealthProgramme we have funded projects, toincrease and enlarge the quality of surveil-lance, to set up clear methodology for tests

Research and innovation inpharmaceuticals:

Covering unmet needs

Androulla Vassiliou

This text is an edited version of a speech given at the Sixth BiennialHealth and Pharmaceutical Summit. Innovation and Value in Healthand Pharmaceutical Care, held in Athens, Greece on 24 November 2008.

Androulla Vassiliou is European Commis-sioner for Health, European Commission,Brussels, Belgium.

assessing the resistance of microbes, and tofollow up the use of antibiotics among theEU population in each Member State.

One of the most recent projects developedis addressing the economic burden ofhuman diseases related to antibioticresistant strains of bacteria. A taskforce isbeing set up within my services to gatherhuman, animal and food aspects in orderto share best practices and find appropriatecontrol options. My services are alsosupporting cooperation between the prin-cipal concerned agencies: the EuropeanCentre for Disease Prevention andControl (ECDC), the EuropeanMedicinesAgency (EMEA) and the European FoodSafety Authority (EFSA). A joint ECDC-EMEA working group is currently devel-oping an analysis, looking at the extent ofantimicrobial resistance and the availabilityof efficient therapeutic agents during thecoming years.

Moving on to more global perspectives, inrecent years, the EU has significantlyincreased its funding for the fight againstHIV/AIDS, malaria and tuberculosis. Oneof the main initiatives in this area is theEuropean Developing Countries ClinicalTrial Partnership (EDCTP). The purposeof this initiative is to accelerate the devel-opment of new vaccines and drugs forHIV/AIDS, malaria and tuberculosis bysupporting clinical trials in Africa in part-nership with developing countries. Since2003, the EDCTP has committed tofunding seventy-four projects that includeclinical trials, capacity building andsupport of research networks. TheCommission has so far contributed around€200 million to the project, with partici-pating Member States contributing thesame amount in co-funding. It is one of thelargest programmes on clinical trials inAfrica and creates an unprecedented andgenuine North/South partnership, concen-trated on the real needs of developingcountries.

In the area of neglected infectious diseases,the Seventh Framework Programme willbuild on the significant progress madewithin previous Framework Programmesthat, since 1997, have provided €70 millionto fund fifty-five research projects. Suchprojects so far have covered a range of rela-tively little-known diseases including,dengue and haemorrhagic fever, buruliulcer and other infections that predomi-nantly affect children. Under theFramework Programme there will be anincreased focus on applying new modernresearch methods and technologies in

order to develop new medicines againstthese diseases.

Another vital element is the focus andeffort in relation to health systemsresearch. In addition to the researchprogramme, the EU also helps to fundglobal initiatives and international partner-ships such as: the Global Fund to FightAids, Tuberculosis andMalaria, the GlobalAlliance for Vaccine Initiative, the Interna-tional AIDS Vaccine Initiative and theInternational Partnership forMicrobicides.

Sound regulatory measuresBut investment in research and innovationis not sufficient. We also need to ensurethat sound regulatory measures are in placeto deal with unmet health care needs. Thepharmaceutical industry clearly needs tomake a return on its investments, not leastto finance and secure its long term work ininnovation. On the other hand, it isimportant that public investment leads toclear gains in terms of a decrease in diseaseburden, health care costs and lost workingdays.

To address these challenges health careregulators have a responsibility, not onlyto encourage research and innovation, butalso to provide guidance and the toolsnecessary to help make the best decisionson where to spend public funds. Theymust also, of course, ensure that new inno-vative pharmaceuticals and other tech-nologies are integrated effectively intoefficient and high quality health systems.

Significant progress in the regulatoryframework has been made at EU level tofacilitate research and innovation and toaddress the multiple objectives of publichealth promotion, rewarding innovationand cost containment. One such exampleis the regulatory framework on orphandrugs, which has provided solid incentivesfor the research, development andmarketing of medicines for rare diseases.These diseases require specialist expertisefor diagnosis and treatment, and by defi-nition it is difficult to provide suchexpertise everywhere in the EU.

The Commission is therefore nowworking on an initiative on rare diseaseswhich aims to improve the availability ofinformation about them and to pulltogether expertise from across the EU sothat all patients can access this. Anotherexample is our recent regulation onchildren’s medicine which covers thedevelopment and authorisation of medi-cines for paediatric use. Studies show that

over 50% of children’s medicines may nothave been tested specifically for children,leaving health care professionals in adifficult position when prescribing suchmedicines. Therefore, it is important toensure the highest quality research, so thatmedicines used for children are specificallyauthorised for such use, and to ensure theavailability of high quality informationabout these medicines.

A third regulatory initiative relates topatent provisions. The EuropeanCommission has been an active member ofthe WHO Inter- Governmental WorkingGroup which produced a draft GlobalStrategy and Plan of Action on publichealth, innovation and intellectualproperty. The Global Strategy wasadopted by theWorld Health Assembly inMay of this year. It aims to give incentivesfor innovation and access to medicines, aswell as to put a focus on needs-drivenresearch and development. By workingtogether with stakeholders, such as repre-sentatives of industry and civil society, toimplement this Global Strategy, we shouldhelp deliver tangible improvementsrelating to the availability, affordability andaccess to medicines worldwide. At thesame time we can encourage an optimalenvironment for pharmaceutical inno-vation.

Measures have also been taken to helphealth care regulators with their dualobjectives of providing better access tohealth care while at the same time trying tocontain public expenditure. Health careregulators and policy makers need to shapenew approaches to make the best use ofavailable public funds. Existing productsand new technologies should be subject tohealth technology assessments to makesure that interventions which bring realtherapeutic added value for patients aremade available.

The EU has therefore taken two initiativesto promote the development of healthtechnology assessments. The first, theEuropean network on Health TechnologyAssessment (EUnet HTA), has developedgeneric tools for adapting health tech-nology assessments made by one countryfor use in other countries. The second, thePharmaceutical Forum, was set up in 2005as a three year process to find solutions topublic health issues regarding pharmaceu-ticals, while ensuring industry competi-tiveness and the sustainability of nationalhealth care systems. Since its inception thePharmaceutical Forum has made a series ofrecommendations on the establishment of

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For thousands of years diagnosis andtreatment were based on what could beseen, tasted, felt, smelled or based on intu-ition. Over the course of the last hundredyears, diagnosis and treatment haveincreasingly been based on our growingknowledge of biochemistry and cellularprocesses. Today diagnosis and treatmentare ever more likely to be based on rapidlydeveloping insights into molecularprocesses and variations in our genes.

Progress in the life sciences, and particu-larly in biotechnology, has led to the devel-opment of new drugs and enabling toolsfor diagnosis. Additionally, the completionof the human genome project has made iteasier to associate specific genes (or genecombinations) with a disease, and thus toidentify novel drug targets.

We are facing revolutionary changes. Inpharmaceutics, the medicine of the future

might well be personalised. It will becomepossible to produce medicines which havefewer side-effects and/or are more effectivebecause they can be more closely attunedto the genetic disposition of the patient.Many developments might be expected asa result of these changes (see Box) but theyalso pose at least three challenges: patientsafety; the availability, access to and afford-ability of quality medicines; and trans-parency of information.

Improving safetySafety lies at the heart of EU drug legis-lation since its beginnings in 1965 when,following the Thalidomide disaster, weinitiated the first directive. We now have asolid set of legal provisions ranging fromclinical trials to manufacturing, marketauthorisation and post market surveillance,as well as covering orphan drugs, paedi-atrics, herbal medicines and last but notleast advanced therapies.

With regard to pre-marketing safety, theEU’s approach has received broad support

fair pricing and reimbursement decisionson pharmaceutical products by MemberStates.

With regard to affordability, I would liketo briefly mention the Bremen processlaunched in the Bremen conference onHIV/AIDS in March 2007. The EuropeanCommission is actively supportingGermany in its efforts in this area, as indi-

cated when in 2007 the Commissionadopted its EU Health Strategy. Oneobjective of the Bremen process is to helpnew EU Member States and our directneighbours to the East, for exampleUkraine andMoldova, to tackle their HIVand AIDS problems effectively by helpingthem to gain access to reduced-price anti-retroviral medicines.

This article provides a snapshot of themany different initiatives the EuropeanCommission is working on to deal withthe unmet health care needs of today andtomorrow. Naturally, we are keen to makefurther progress together with key stake-holders, all of whom share the same coreobjective: to provide the highest qualityhealth care for citizens.

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Does fostering pharmaceuticalinnovation and competitivenessbenefit the European patient?

Georgette Lalis

This text is an edited version of a speech given at the Sixth BiennialHealth and Pharmaceutical Summit: Innovation and Value in Healthand Pharmaceutical Care, held in Athens, Greece on 24 November 2008.

Georgette Lalis is Director,DG Enterprise and Industry,European Commission, Brussels, Belgium

Box: Potential future developments

• More convergence in technologies, i.e.more combination products (for example,combination medical device/medicinalsubstances)

• Advanced diagnostic tests for earlier andmore accurate diagnosis

• More emphasis on prevention and a moreholistic approach, to chronic disease inparticular

• More personalised treatment instead ofnon-targeted broad-based therapies

• More use of genomics to enable physiciansto deliver higher quality, cost-effective carefaster to more patients

• More ambulatory surgery to allow patientsto return home rapidly

• Less invasive treatment options, with betterclinical outcomes and shorter recoverytimes and a general reduction in the lengthof hospital stay

• Greater use of home based diagnostics bypeople with chronic conditions, includinghigh blood pressure, diabetes, asthma andheart problems

• Wider and improved data mining, i.e. inparticular, hospital data will become asource of valuable information andimprove the conclusions that may be drawnfrom clinical studies

and is held in high esteem internationallyfor the rigorous assessment of safetyquality and efficacy it provides. TheEuropean Medicines Agency has animpressive track record in delivering high-quality assessment and speedy access ofinnovation to the European market.

Recent events linked to adverse reactions,coupled with the upswing in detectedcounterfeit medicines, demonstrate that thesafety of medicines remains a major publichealth issue. There is an urgent need toaddress the potential dangers broughtabout by the globalisation of the valuechain. New markets (for example, China,India, Brazil, Russia, Indonesia, Mexicoand Turkey) have become centres forproduction of Active PharmaceuticalIngredients (APIs) and prime sources forEuropean imports of those substances. Agrowing number of medicines are nowdeveloped simultaneously in multi-centrestudies on different continents. Ingredientsand finished products are ever moresourced through international distributionchannels. This makes the task of authoritiescharged with evaluating trials andinspecting sites more difficult and resource-intensive.

The Commission’s Report on CommunityCustoms Activities on Counterfeit andPiracy for 2007 revealed that medicinesseized by customs authorities increased by628% in just two years (2005–2007). Thisnot only affects so-called ‘lifestyle’products, but also essential treatmentsagainst life-threatening diseases. It is avivid reminder that action against counter-feiting is urgently needed.

The Commission now intends to submitlegislative proposals within its forth-coming Pharmaceuticals Package, in orderto rationalise and strengthen the EUframework on safety monitoring (pharma-covigilance), and to address the topic ofcounterfeit drugs. Various measures areproposed, ranging from product-relatedmeasures (such as obligatory safetyfeatures and traceability) to strengthenedobligations and reporting mechanisms forthe whole supply chain including APImanufacturers and distributors.

But measures aimed only at the EUmarketare no longer sufficient. Global industryrequires the global cooperation of regu-lators and global monitoring. As scarceresources have to be used efficiently, inten-sifying regulatory cooperation with theUS, Japan and Canada, both within theInternational Conference on Harmoni-

sation of Technical Requirements forRegistration of Pharmaceuticals forHuman Use (ICH) and existing confiden-tiality arrangements, remain our priority.Our field of cooperation will extend tomutually agreed mechanisms for jointinspections in third countries.

At the same time, we are intensifyingbilateral cooperation with targeted thirdcountries that are important trade partners.New mechanisms for the exchange ofinformation on illegal distributionchannels and counterfeiting, as well as onclinical trials and the manufacturing ofAPIs, are being established with Russia,India and China.

Availability, access and affordabilityThese three issues are of extreme impor-tance if we want the innovative drugs thatour societies need to be available andaccessible to EU patients at an affordableprice. Turning first to the supply of drugs,there is an ongoing debate in the WorldHealth Organization (WHO) and otherinternational fora on what are the prioritydrugs for combating diseases across theworld. This gives rise to the question ofwhether the concept of priority drugs isrelevant and valid and, if so, whether deci-sions should be left to industry alone.

We see more and more private organisa-tions interfering in defining the needs ofless developed countries. Should we notalso engage in a wider discussion betweenpolicy makers, industry and patients onthe drugs that our ageing societies need?We know already, for example, that thepipeline is full for oncology, much less sofor neurological diseases and, most worry-ingly, almost empty for antimicrobialresistance. On a more general level, is thepresent business model, dominated by the‘one fits for all’ approach – the blockbustermodel, still valid?

But this is only one part of the question.The other part is whether Member States’public health budgets are capable of copingwith such innovative drugs? The sustain-ability in financing of an ever moremodern (and probably more costly) healthcare sector is a concern which requires ourundivided attention.

Socially less favourable ramificationsmight also materialise, namely signs of atwo-tiered polarised health care system.Health insurance systems might be forcedinto no longer paying for everything, andthose who can purchase their services inthe private for-profit market will do so,

thus creating socioeconomic inequalitiesand a health divide between the rich andpoor, young and old. The concept of soli-darity and the European social modelmight come under increased stress ifmeasures are not taken early enough.

Tomake future innovative drugs accessibleto the patients of Europe, we need toensure that:

(1)Development and marketing costs mustbe brought down by industry. Attritionrates are too high. Fewer substancesovercome the costly and time-consumingpre-market authorisation requirements.We hear more and more about the benefitsof personalised drugs and therapies. It isfair to say that such drugs will beextremely efficient, thus saving both thelives of patients and money to health carepayers. However, with the existing devel-opment models and rate of attrition, wealso know that they will necessarily bemore costly, as a smaller number ofindustry actors will bear their develop-ments costs. At the EU level, industry andthe Commission have created a part-nership, the Innovative MedicinesInitiative, in order to foster research intonew pathways for the development ofinnovative drugs. We place our hopes inbiomarkers to reduce both costs and therate of failure. When this researchproduces results, we will consequently beable to update the regulatory framework.

Equally, too much money is spent byindustry on marketing rather thanresearch. This is part of the business modelthat has to be reviewed because it hasreached the limits of its sustainability. Notonly are payers less and less ready to payfor such costs, but it also tarnishes theindustry’s image.

(2) Regulators, policy makers and payershave to review their pricing and reim-bursement systems to reward innovationand promote the use of generics and overthe counter products. The EU has a singlemarket, albeit not perfect, for marketauthorisation but a fragmented market asfar as pricing and reimbursement areconcerned. The combined effects ofdifferent national systems through paralleltrade is detrimental to both industry andpatients. Public health budgets should notoperate as silos where pharmaceuticalexpenditures are determined in isolation.The global benefits that a drug createsshould be taken into account whendeciding on reimbursement. The design ofintelligent cost-containment measures is of

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paramount importance to the future.

The promotion of generics is also of para-mount importance if we want to createheadroom to reward innovation, whilemaking expensive drugs broadly availableto patients. The European Commissionlaunched a sector enquiry to examine therelationship between originators andgenerics, and more specifically the waysintellectual property rights and agreementsbetween companies influence the entry ofgenerics into the market. Indeed, the EUCommissioner for competition presentedthe first results of this inquiry on 28November 2008.

(3) Finally, and I realise that this point isdebatable, we might have to engage in asocietal debate on the notion of risk-benefit. No drug is safe and the samples wehave from phase III clinical trials are notenough to ensure the best possible risk-benefit assessment. At the same time, oursociety seems to have become increasinglyrisk- averse, while at the same time patientsaffected by a disease expect new drugs tobe available on the market as soon aspossible. It is clear that increasing safetyvia regulatory requirements increasescosts. Should we make a wider use of riskmanagement plans and phase IV studiescombined with a robust pharmaco-vigilance system? The debate is open.

There are, however, two other importantaspects concerning the availability of inno-vative drugs.

One is the fact that some Member Statesthat represent small markets for pharma-ceuticals experience shortages in drugs,especially for products of low volume, lowprice or those intended to treat severeand/or rare diseases. Let us not hide thefacts: Cyprus and Malta are most severelyaffected but other Member Statesencounter the same problems.

This is an unacceptable situation that wecannot tolerate within the EU. Over thepast few years we have had intensivediscussions on the issue. We started by firsttrying to understand the contributingfactors and then subsequently developingsolutions within the relevant network ofthe Heads of Medicines’ Agencies, andfinally, within the Pharmaceutical Forum.

A series of recommendations were formu-lated, some of which have to be taken tothe regulatory level, for example by simpli-fying the Mutual Recognition Proceduresto allowMember States who wish to do soto rely completely on an agency in another

Member State, or by waiving the languagebarrier. Another idea discussed waswhether those drugs considered within thecentralised procedure should not be placedon the markets of all Member States, if themarket authorisation holder wants tobenefit from the advantages linked tocentralised market authorisation. Othersolutions, notably those linked toeconomic aspects of the supply of drugs inthese Member States, have yet to betackled. I refer here to the way the whole-saling of drugs is organised, the way publicprocurement is designed, and finallypricing and reimbursement regimes. Thisis certainly an issue that will stay on ouragenda, especially our regulatory agenda,for years to come.

The second issue is the impossibility ofsome Member States to reimburse criticalmedicines, in particular due to a lack ofadequate financial resources. This issue hasreached the highest political levels, asexemplified by the ‘Bremen Declaration’in the case of HIV/AIDS, where healthministers invited industry to commit tocooperating in order to ensure access toaffordable medication for patients inseveral new Member States. For instance,those Member States, and their patients,saw the price of HIV medication dramati-cally increase following their accession tothe EU (this is a collateral effect of paralleltrade that is seldom discussed).

For issues related to pricing and reim-bursement the Pharmaceutical Forum hasproven an interesting experience. Acommon set of guiding principles has beenadopted by that Forum to support futurenational pricing and reimbursementpolicies. The positive experience of infor-mation exchange and cooperation betweenMember States and with stakeholdersshould be strengthened at EU level. Moreefficient market mechanisms and, inparticular, price competition for non-reim-bursed medicines, would provide, in thissector, more patient choice at a moreaffordable cost. Recommendation six ofthe G10 group was again endorsed by theForum. It stipulates that Member Statesshould remove price controls on manufac-turers that prevent full competition inauthorised medicines that are neitherpurchased nor reimbursed by the State.

Further developments in health tech-nology assessment will also offer valuablesupport to national authorities in striking abalance between containing pharmaceu-tical expenditure and ensuring a fairreward for valuable innovation and access

to the best available medicines. Cooper-ation among authorities and dialogue withstakeholders will be a prerequisite toachieving such a balance.

The results of the Pharmaceutical Forumshow what can be achieved throughdialogue and cooperation among stake-holders. We will be able to progress onlythrough close co-operation, i.e. a genuinepartnership between the Commission, theMember States, industry and all otherplayers concerned.

Information and transparencyAs outlined in the Commission’s WhitePaper on Health Strategy, patients arebecoming more involved in decision-making regarding their health. They have aright to more quality information onavailable medicines, the grounds on whichthey have been authorised and how theyare monitored.

However, information provided by publicauthorities currently varies considerably,and media such as the internet may notalways provide reliable or comprehensibledata. This is to say nothing of the fact thatthe internet is not accessible to all. Thiswas also underlined in a report preparedby the Commission in response to arequest from the European Parliament andthe Council.

Public authorities and health care profes-sionals have a crucial role to play inproviding patients with relevant andimpartial information. The PharmaceuticalForum endorsed recommendations toenhance the generation, access and dissem-ination of good quality information ondiseases and treatments. The use of qualityprinciples and increased cooperationamong all partners for developing patientinformation should lead to tangibleimprovements for citizens.

On this basis, the Commission considersthat the role of industry in this contextshould be clarified. Advertising isprohibited in Europe for prescriptiondrugs. The provision of information byindustry on prescription drugs is notharmonised at EU level and industrytherefore has to contend with differentlegal systems in the twenty-seven memberstates. All might agree that this is hardly asituation that can accommodate web basedinitiatives that cannot be contained withinfrontiers. Possibly the only barrierremaining in the EU is language.

The European Parliament has thereforeasked the Commission to look into the

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PERSPECTIVES FROM THE COMMISSION

issue of rationalising the availability andimprove the quality of information topatients within the EU on prescription-only medicines, while maintaining theprohibition on advertising. ACommissionproposal is due to be adopted in thecoming weeks.

I come now to the last issue that is dear tomy heart and to patients and consumersequally. It is the question of transparency.For a long time this industry wasperceived as being keen not to discloseinformation that might harm thecommercial value of its drugs. I speak ofthe past because I think that a lot hashappened on this in recent years and, inparticular, attention has been brought tothe issue by the VIOXX crisis. It is fair tosay that if patients are to take risks ondrugs they need to know these risks inorder to make an informed decision. Theyneed to be confident that full light hasbeen shed on results arising not onlyduring the premarket phase but also in thepost market life of a drug. It is thereforeof paramount importance that, in parallelto what one or the other company maydecide to do to improve the situation, weas the European Commission placemandatory obligations on national regu-latory agencies, sponsors and marketauthorisation holders. We will do so onevery occasion we can.We started with thepaediatrics regulation; we continue withpharmacovigilance (publication of theopinion of the pharmacovigilancecommittee, patient reporting and patientparticipation in hearings); and will go onin a couple of years with the revision ofthe clinical trials directive. When doing so,we feel we can only help the industry inimproving its image.

Policy makers and industry together haveto make further progress towards a singleand sustainable market in pharmaceuticals.We have to take on the opportunities andchallenges of globalisation and we have tomake science deliver the best for Europeanpatients. Finally we have to restore theEU’s role as the natural home for pharma-ceutical innovation.

POSTSCRIPT

The Commission proposals concerningpharmacovigilance, counterfeiting andinformation to patients, the ‘PharmaPackage’ were adopted by the Commissionon December 10, 2008. More informationat http://ec.europa.eu/enterprise/pharma-ceuticals/pharmacos/pharmpack_en.htm

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PERSPECTIVES FROM THE COMMISSION

Health systems and the challengeof communicable diseasesExperiences from Europe and Latin America

Edited by: Richard Coker, Rifat Atun and Martin McKee

“This is an excellent book,well written and welldocumented.

“Public health actorswhether in research,teaching or practice as wellas professionals working indiagnostic and therapeutichealth services couldgreatly benefit from readingthe book. Politicians andlay administrators withresponsibility in the fieldwould be well advised to dothe same.”

Nils Rosdahl, Specialist inPublic Health, Past-President, Danish Societyof Public Health 1995–99,European Journal of PublicHealth 2008;18(6):122.

Health systems everywhere face constantchange as they seek to respond to evolvingpatterns of disease. This is especially true withcommunicable diseases where humanity isengaged in a constant evolutionary strugglewith microorganisms that are able to adaptrapidly to a changing world.

This fascinating book looks at two regionswhere the pace of change is especially rapid,Europe and Latin America – places wherehealth systems are themselves undergoingrapid organisational transition.

The book begins with an historical overview ofthe way in which humans and microorganismshave always competed, before examining thecurrent status of this evolutionary struggle. Itassesses the extent to which human societiesand their governments are prepared for thechallenges ahead and reviews the experiencesof countries in Europe and Latin America indeveloping effective responses.

Health systems and the challenge ofcommunicable diseases will be of interest topolicy-makers in high- and middle-incomecountries, and to students of the creation andimplementation of health policy.

Published by Open University Press, 2008

European Observatory on Health Systems andPolicies series, 266 pages

ISBN13 978 0 335 23365 6 (hardcover), £70.00

Also available for download at:http://www.euro.who.int/Document/E91946.pdf

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EUROPEAN SNAPSHOTS

TheMinister ofHealth, Roselyne Bachelot,is about to put her name to an ambitiousreform package which, if adopted, wouldtransform the organisation and provisionof hospital care in France. The contro-versial draft law, which will be subject to avote in the French Parliament in January2009, aims to improve the supply and coor-dination of health care at the regional level.To do this, the text suggests modifying notonly the organisation and governance ofhospitals but also medico-social servicesand ambulatory care.

The focus of health care policy in Francehas long been about controlling a publichealth insurance deficit that is estimated toreach €4.1 billion by the end of 2008. Afterdecades of successive reform plans whichmainly proposed short term remediesaimed mostly at restricting demand, thenecessity of more structural reforms hasbeen recognised by most parties/stake-holders. In particular, the split between themanagement of health care provision andthe supervision of health care expenditurehas been identified as a major structuralweakness in the French system. Thecompartmentalisation of ambulatory,hospital and social care and the lack ofarticulation between central, regional anddepartmental levels have also been seen asmajor drawbacks, both in terms of costcontrol and quality of care in France.1

Towards a unique regional healthauthority‘Regional Health Agencies’ (AgencesRégionales de Santé, ARS) are at the coreof the reform package put forward byMinister Bachelot. These agencies havebeen on the political agenda for more thana decade. If the reform package is approvedby Parliament in January, the ARS will be

rolled out in 2010. Currently, mosthospital activities are controlled byregional hospital agencies (AgencesRégional d’Hospitalisation, ARH), butseveral different state agencies are respon-sible for the provision and financing ofdifferent types of long term and social care.Although the idea of creating regionalhealth agencies, with an enlarged respon-sibility for controlling all types of inpatientas well as outpatient care, has been aroundfor a long time, it has proved difficult toimplement. The idea was however revivedby President Sarkozy. His presidentialprogramme includes a ‘modernisation’agenda for greater liberalisation within thehospital sector.

These new agencies will bring together,along the lines of a ‘one-stop-shop’, thevarious stakeholders that are responsiblefor health care policy at the regional anddepartmental level. These include repre-sentatives of public insurance funds andlocal state authorities responsible for socialand home care services. The objective is tosimplify regional health management whilestrengthening the coherence of territorialpolicies. The ARS will have a mission todefine ‘health care needs’ at the regionallevel and guarantee fair access to care,improving coordination between hospital,ambulatory and social care providers.They will oversee both public and privatehospitals, as well as nursing homes. Eachhospital will have to sign an annualcontract to secure funding. The ultimateobjective is to make the ARS act asresponsible purchasers, contracting withindividual hospitals rather than passivelypaying for services.

Primary care gets a nod in the reformpackageThe ARS will not have the responsibilityfor purchasing primary care or formanaging the budgets for ambulatory caredelivery, as these have been based onhistorical principles of private practice

(médicine libérale). The reform aims,however, to redefine the organisation ofambulatory care which, until now, has beentreated as a separate issue. For the first time,the term ‘primary care’ (which did not existin French) will appear in the public healthcode. The responsibilities of general practi-tioners will be defined in law, with the aimof enhancing their role and status.

The draft law also focuses on tacklinginequalities in the geographic distributionof physicians. This has been a chronicproblem in France due to the ‘sacrosanct’principle of ‘freedom of establishment’ forphysicians. The objective is to introducefinancial penalties to discourage physiciansfrom establishing practices in areas withhigh doctor density. But given the sensi-tivity of the subject, the proposed reformis rather timid, with responsibility forfuture regulation to be passed to the ARS.There are also proposals to improve after-hours care at the regional level to relievecongestion at hospital emergency servicedepartments. Despite these symbolicefforts, overall the proposal is judged asbeing insufficient for developing realprimary care practices that could improveboth the quality and coordination of care.

New hospital communitiesAnother significant structural change willbe the creation of new legal entities called‘local hospital communities’ (communitéshospitalières de territories, CHT). Theywill be formed by regrouping a range ofsmall and large scale hospitals on the basisof the complementarity of their compe-tencies. The idea is to concentrate complexsurgical interventions in high volumehospitals and transfer less complex medicaland medico-social care to small localhospitals. In principle, hospitals within aCHT will be able to share their patients aswell as their health care resources. Forexample, a small hospital could transfer itsmost severe patients to a larger facility,while such facilities could lend specialists

Changing regional healthgovernance in France

Zeynep Or

Zeynep Or is Senior Research Fellow atthe Institute for Research and Infor-mation in Health Economics (IRDES),Paris, France. Email: Or@irdes.fr

In Europe, health service regionalisation –that is, states decentralising the delivery ofpublic health care services from ministriesof health to delegated administrative bodies– has existed for a long time. In those coun-tries where regionalisation was adopted,such as the United Kingdom in the mid-1970s, higher-level policy and monitoringfunctions in the Ministry of Health wereseparated from management and deliveryfunctions on the ground. This was based on

a simple but powerful idea “that smallerorganisations, properly structured andsteered, are inherently more agile andaccountable than larger organisations”.1

Decentralising management and servicedelivery is an idea that has been adopted invarious forms in a number of WesternEuropean countries, from Sweden andDenmark in the north, to Spain and Italy inthe south. It is now at the centre of a majordebate in France, where a draft law on thecreation of ‘Regional Health Agencies’,vigorously contested by some of the mostpowerful stakeholders in the country, willbe debated in the French Parliament inJanuary 2009. This controversy provides anopportune time to review the Canadianexperience with decentralisation andregionalisation, including the most recent

debate that has been triggered by thedecision of one province, Alberta, to elim-inate its regional health authorities infavour of a more centralised managementand delivery system.

Decentralisation in CanadaEven before the introduction of regionalhealth authorities in Canada during the1990s, the public health care system wasrelatively decentralised. As provincialgovernments have the primary responsi-bility for health care and other socialpolicy under the constitution, they havebeen responsible for administering tax-based, single-payer administrative systemsfor universal public health care services fordecades. When the three northern terri-tories are considered in addition to the ten

Regionalisation reversal in Canada

Gregory P Marchildon

Gregory P Marchildon is CanadaResearch Chair in Public Policy andEconomic History, Johnson-ShoyamaGraduate School of Public Policy,University of Regina, Saskatchewan,Canada.Email: Greg.Marchildon@uregina.ca

to these smaller hospitals for a couple ofafternoons a week.

The problems of quality in low-volume,small hospitals for complex surgery havebeen a preoccupation in the past couple ofyears, particularly since the publication ofthe influential Vallancien report.2 Volumethresholds have been introduced bynational agencies for carrying out complexcardiovascular and cancer surgery. This haslead to the centralisation of these services,but to date there has not been any realreflexion at the regional level on how todeal with hospital closures and problemsof access.

This is one of the most controversialaspects of the reform as the hospital feder-ations perceive the proposal as the official‘end of the small hospitals’. Hospitalclosure is a very sensitive issue and therehave been several demonstrations againstthe reform project even before the consul-tation process started. Following adversereactions from both the hospital federa-tions and the trade unions, the Minister ofHealth has now given an assurance thatthere will be no hospital closures, only atransformation in their function.

Furthermore, the rules of management in

public hospitals will be simplified andhospital directors will gain real autonomyin management, with better defined objec-tives and results-based evaluation. Onenovelty is that they will have more flexi-bility in recruitment decisions, includingthe possibility of establishing part timecontracts with private practitioners. Modesof remuneration for physicians will also bemore flexible, allowing for the intro-duction of performance-based payment. Inturn, hospital directors will sign annualcontracts with the ARS setting out specificactivity and quality objectives.

Some scepticism remainsDespite the fact that most of the measuresproposed in the reform package do focuson long-awaited structural changes tostrengthen regional governance andemphasise the importance of coordinatedcare in the system, the initial reactions ofalmost all stakeholders have been highlycritical. This is partly due to a poorlyorganised process of consultation, inwhich most stakeholders were unhappywith the lack of dialogue and debate on thedraft law.

One major issue, still under negotiation, ishow power will be shared within the new

regional health agencies. National sicknessfunds are particularly worried about howmuch power they will have within thefuture ARS. They are also concerned aboutthe potential risk of increased state control,given that the directors of ARS will benominated by the government’s council ofministers (cabinet).

REFERENCES

1. Larcher G (chair). Etat des lieux réalisépar la commission de la concertationrelative aux missions de l’hôpital [The roleand place of the hospital: an inventoryprepared by the consultative commissionon hospital missions]. Paris: Ministry ofHealth, Youth, Sport and CommunityOrganisations, 2007. Available athttp://www.sante-jeunesse-sports.gouv.fr/IMG//pdf/Dossier_conference_de_presse_Gerard_Larcher_21_decembre_07.pdf

2. Vallancien G. L’évaluation de la sécurité,de la qualité et de la continuité des soinschirurgicaux dans les petits hôpitaux publicsen France [Evaluation of security, qualityand continuity of surgical care in smallpublic hospitals in France]. Paris: Ministryof Health and Solidarity, 2006. Available at:http://www.ladocumentationfrancaise.fr/rapports-publics/064000350/index.shtml

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provinces, this means that Canada hasthirteen separate public health care systemsthat vary dramatically in population andsize; for the provinces, these range fromOntario (1.1 million km2) with its thirteenmillion people – the population size of anumber of European states – to tiny PrinceEdward Island (5,660 km2) and its 140,000residents – less than one-half the popu-lation of Iceland.

The province of Saskatchewan’s innovativeintroduction of universal hospital andmedical care insurance combined with thefederal government’s agreement to costshare expenditures, led to the eventualestablishment of universal hospital andphysician care in Canada in the 1950s and1960s. In the 1970s, provincial govern-ments began to administer, subsidise orotherwise support other health careservices, including prescription drug plans,home and long-term care. Althoughnumerous commissions and studies of theday recommended that provincial govern-ments introduce regionalisation in order tobetter co-ordinate and integrate the organ-isation and management of these services,it would take at least another two decadesfor regionalisation to be implemented, inpart because of opposition from existingstakeholders, particularly physicians andprivate not-for-profit hospitals. In themidst of a fiscal crisis caused by decades ofaccumulated public debt, nine provincesand one territory established regionalhealth authorities (RHAs) between 1990and 1997.

While the number of RHAs, and thepopulations they encompassed, varieddramatically in each province, each RHAhad its own board of directors responsiblefor governance and a single executivemanagement team under the direction of achief executive officer. Each RHA acted asa provider, as well as a purchaser, ofservices.

As a structural reform intended to achievesubstantive health service reform, region-alisation everywhere in Canada sharedthree common characteristics: (1) throughRHAs, rationalise, coordinate and inte-grate what had been a fragmented set ofhealth care organisations – from hospitalsand long-term care institutions tohome/community care and public healthactivities – in order to improve the qualityand appropriateness of care; (2) decen-tralise health budgets from provincialministries to RHAs so that healthresources would be allocated on the basisof local needs as defined by those closer to

the population receiving services; and (3)reallocate scarce resources from down-stream hospital and institutional care, tomore upstream primary care and publichealth services, and determine the servicesand policy interventions appropriate to thepopulation being served within ageographically delimited area.

In the years following the reforms, somedifficulties and trends were discernable,including considerable tension betweenprovincial ministries of health and RHAsconcerning respective responsibilities andauthorities. Although there was noconsensus concerning the optimal numberof RHAs, most provinces eventuallyreduced the number of RHAs originallyestablished. There remain significant diffi-culties concerning the direction and speedof primary care reform; indeed, themajority of physician remuneration in allprovinces continues to be fee-for-servicesand the ministries of health, rather thanRHAs, remain responsible for physicianremuneration. Finally, there has been nomajor study concerning the impact – atleast in terms of improvements to servicedelivery – of regionalisation.

In 2005, Ontario belatedly joined themajority of provinces by establishingfourteen Local Health IntegrationNetworks (LHINs). The Ontario modelof regionalisation differed from the modelin the rest of the country. Unlike RHAs,LHINs are limited to purchasing and co-ordinating services within their geographicareas. At the same time, the province ofPrince Edward Island disbanded its RHAsand centralised all administration andmostdelivery in its health ministry. However,most commentators at the time concludedthat Ontario’s adoption of regionalisationmeant that this structural reform was hereto stay in Canada.

Regionalisation reversalThis remained the case until May 2008when the provincial government of Albertasuddenly announced the elimination of itsnine health regions. Immediately replacingthe RHA boards, and soon to replace theadministrative structures in the regions, theAlberta Health Services Board will admin-ister all health services in a province withalmost 3.5 million residents. By Canadianstandards, this is centralisation on a grandscale, and the decision shocked observersbecause no study or commission recom-mendations preceded the change. The argu-ments used by the Alberta government tojustify the shift are almost identical to those

used by the Irish government when it elim-inated its health boards in favour of a singleorganisation – theHealth Service Executive– responsible for service deliverythroughout Ireland. These include clari-fying roles and responsibilities by consoli-dating and amalgamating a complex ofboards and their executives into a singlegovernance and administrative unit;obtaining greater value for money throughstreamlining and consolidating serviceswithin the province; introducing morepatient-centred (‘21st century’) care; andensuring greater consistency and quality ofservice throughout the province.

What does the future hold for regionali-sation in Canada? The answer is far fromclear but the Alberta decision may stim-ulate major structural changes in otherprovinces. It also offers a natural exper-iment. If the new structure introduced bythe Alberta government can even beconsidered a type of regionalisation, wecan say there are now three models ofregionalisation operating side-by-side inCanada. There is the decentralised RHAmodel in eight of Canada’s ten provincesin which there is a purchaser-providerdivision between the ministries and healthregions. There is the even more decen-tralised LHIN model in Ontario model,with a further ‘pure’ purchaser-providersplit between the LHINs and individualhealth organisations. And there is now thecentralised model in Alberta in which oneorganisation, the Alberta Health ServicesBoard, is responsible for all servicedelivery in the province, and another, theprovincial ministry, responsible for broadpolicy direction. All three models ofregionalisation can be compared to acontrol – the one province and two terri-tories which continue to have healthministries responsible for all public healthcare delivery. If governments withinCanada can desist from further structuralchange for the next five years, and if goodcomparative research can be completed,this experience should prove useful toother countries considering some form ofregionalisation reform.

REFERENCE

1. Saltman RB, Bankauskaite V, VrangbækK. Introduction: the question of decentral-ization. In: Saltman RB, Bankauskaite V,Vrangbæk K (eds). Decentralization inHealth Care. Buckingham: OpenUniversity Press, 2007. Available athttp://www.euro.who.int/observatory/Publications/20070223_1

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After some quiet years, the pace of post-1989 health care reform in the CzechRepublic seems to have picked up. Inaddition to the common challenges facedby health systems across Europe (ageingpopulations, rising expectations of citizensand technological advances), the healthcare system in the Czech Republic is strug-gling with an inefficient use of health careresources, the implications of the globalfinancial crisis and overconsumption ofhealth care by the population. Togetherthese factors may threaten the system’sperformance and sustainability.

Proposed reforms to address these issuesare intended to increase efficiency andstabilise the system; while improving bothaccess to and the quality of health careservices; and strengthening the role andresponsibilities of the patient.1 A key firststep in achieving these goals is tomodernise health care legislation that datesback to 1966,2 so that it better reflects theneeds of the population. This snapshot willbriefly describe proposed legislativechange and the ensuing political debate.

Reforms will bolster patient rightsA number of health care reform bills havenow been prepared as part of a package ofinterrelated laws (See Table). The five newbills being considered by the legislaturewould reorganise the regulatoryframework into more logical groupings,i.e. the general rights of patients would beseparately stated, while the specific rightsof insurees would be placed within

proposed new laws for public healthinsurance (PHI).

Following an extensive and ratheremotional discussion on backgroundpolicy documents3 prepared for the newbills*, the Ministry of Health decided toproceed in two stages. First, to begin thediscussion and legislative process related tothe rights of patients, patient-providerrelationships and the obligations of serviceproviders set out in Bills 1, 2 and 3 andthen subsequently to move to Bills 4 and 5that propose changes to the regulation ofthe public health insurance system.

Currently, relevant legislation is not to befound in one place, but rather is frag-mented across numerous regulations,where the patient is still viewed as a passiveparticipant. The new Bill on HealthServices and Requirements for TheirProvision can thus be considered as anumbrella bill directly linked to the subse-quent bills on special health and emer-gency services. Primarily the emphasis ofthis umbrella Bill is on the safety and rightsof the patient, making him or her for thefirst time a ‘consumer’ of services across

the entire system. For example, it benefitspatients by giving them the right to refusehealth care services and obtain clear infor-mation about health services and theirprices. It also specifies how complaintsshould be dealt with and when providerscan be sanctioned. Interestingly, the Billalso sets out obligations and responsibil-ities for patients, in particular in respect ofactions which may positively impact ontheir health; for example, the obligation tomake preventive health care visits and/orto adhere to treatment. The Bill also clearlyspecifies the conditions under whichproviders can obtain or indeed lose apermit to deliver services, as well as thosesituations in which they can legitimatelydeny care to patients.

Other elements of the Bill include newdefinitions of the types and level of healthservices, thus delineating the frontiers ofthe health system. For example, generaltransportation services from or to a healthcare facility are no longer considered ashealth services and can be provided bynon-health care employees. These newdefinitions will be directly relevant whenspecifying services to be covered by PHI.Finally, the Bill should help improvequality and safety in the system. Forexample, ‘care standards’ for serviceproviders that reflect the most up to dateknowledge in clinical medicine are recom-mended. These standards will refer to clin-ically effective guidelines specified by theMinistry of Health, health insurancecompanies and service providers.

Special services which require morestringent regulation and ethical considera-tions are to be covered in a Bill on SpecificHealth Services. The proposed Bill focuseson safeguarding patient rights in respect ofsensitive services such as assisted fertili-sation, sterilisation, cloning, blood

Czech Republic: First steps onthe path to health care reform

Lucia Kossarova and Henrieta Mad’arová

Lucia Kossarova is reading for a PhD,LSE Health, London School of Economicsand Political Science and HenrietaMad’arová is an advisor on healthinsurance reform to Czech Minister ofHealth and a member of Reformazdravotnictvi-forum, Czech Republic.Emails: lkossarova@lse.ac.uk andmadarova.henrieta@gmail.com

Table. Overview of proposed health carelegislation4

1. Bill on Health Services and Requirementsfor their Provision

2. Bill on Special Health Services

3. Bill on Emergency Services

4. Bill on Public Health Insurance

5. Bill on Health Insurance Companies andthe Health Insurance CompaniesSurveillance Authority

* Before any new legislation is drafted the government must first approve policy documentssetting out the issue, current legislation and a description and arguments for proposed reform.

donation and pregnancy terminations.Attempting to harmonise this Bill with EUlegislation has led to vigorous debate. Forexample, allowing any EU female citizento obtain a termination in the countryunder the same conditions that apply toCzech women has raised a myriad ofethical and ideological issues whichcontinue to be discussed in Parliament.

A third Bill on Emergency Services aims toimprove access to emergency services (ES)for the entire population, adjusting theway these services are provided andfinanced, while improving coordinationbetween different health care entities. Forexample, while current legislation statesthat all individuals should have access toES within fifteen minutes, as much as 12%of the population have to wait up to thirtyminutes. The new bill would take intoaccount demographic, geographical andother risk factors and set a more realisticlimit of between fifteen and twentyminutes. By re-designing the ES networkand creating forty-four new ambulancestations, almost the entire populationcould be reached within fifteen minutes,with a mere 2% of the population havingto wait twenty minutes. Furthermore, theES network will be financed by healthinsurance companies and the state budgetrather than in the current system, where itis funded by regional governments, oftenleading to differences in per capitaspending and access to services.

The three proposed Bills, if enacted, wouldenshrine the role of patients as decisionmakers and the patient-provider rela-tionship within legislation, unlike theoutdated 1966 law. Repealing the 1966 Actwould also require the repeal andamendment of a number of other healthlaws and regulations, including, mostimportantly, amendment to Law 48/1997on Public Health Insurance.

The revised terminology in all threeproposed bills would enable much neededimprovements and clarifications in thedefinition of the basic benefits package(BBP) covered by PHI. In general, thescope of services covered by PHI wouldstay the same but the proposed definitionis more precise. It states that health servicescovered by PHI should be responsive tothe health needs of patients, based on thelatest medical knowledge and provided incompliance with the cost effective utili-sation of health system resources. The newdefinition of BBP will be supported bytwo lower level instruments: a bylaw onthe catalogue of health services, as well as

clinical guidelines that should ensure theprovision of the most clinically effectivecare, taking into account individualcircumstances.

At present, only standard treatment iscovered by PHI and all alternativetreatment options are usually paid in fullby the patient. The new definition wouldmean that patients would only have tocover the differences in cost between alter-native and standard PHI reimbursedoptions. These rules are similar to thosealready in use for drug reimbursementpolicies that have lead to improvements inefficiency. The proposed definition of BBP,coupled with new clinical guidelines, willhelp to standardise the quality of care,something which at present is left entirelyto the discretion of service providers. Notleast, patients will knowwhat services theyare entitled to under PHI and thus avoidunnecessary co-payments for theseservices. The amendment bill to Law48/1997 includes new exemptions fromuser fees for the most vulnerable groups(primarily children, dependent olderpeople and others living in long term carefacilities) and reductions in the limits onuser fees and out of pocket spending forselected co-payments for drugs.

The first three bills and the amendment toLaw 48/1997 have already been presentedto the Parliament and are expected to beapproved in the first quarter of 2009. Bothwithin the governing coalition and theopposition, the most controversial discus-sions at present gravitate around the newdefinition of the BBP and the list ofexemptions from user fees. Most of theconcerns with this new definition relate tothe provision that full reimbursementapplies only to the most cost effectivetreatments for the individual, dependingon their needs. On the one hand, it isgenerally accepted that resources in thehealth system are limited and should beused more efficiently. On the other, aminimum level of quality and standards ofhealth services, as well as access to infor-mation on alternative treatment options, isexpected to be guaranteed and definedthrough bylaws. This should avoidexcessive and fraudulent co-payments fortreatments that have been viewed as being‘above’ standard but which in fact arestandard treatments.

The discussion on user fees is focused onthe identification and exemption of thosegroups that are perceived as being mostvulnerable. The definition of this groupmay however change in light of the high

inflation in food and fuel prices during2008 and the impact of the global financialcrisis on the economy, employment andwages. However, due to the disputeswithin the coalition and loss of theirmajority, all user fees were repealed in thelower chamber of Parliament at the end ofDecember 2008. It is hoped that the upperchamber will be able to reach a consensuson the list of exemptions from user feesand revoke the lower chamber decision. Ameeting is planned for the end of January2009.

Reform of private health insuranceDespite the benefits of these threeproposed laws, current legislationgoverning PHI is still not deemed to besufficient and will require furtherimprovement. That will only be possiblewhen discussions on Bills 4 and 5 – the Billon Public Health Insurance and the Bill onHealth Insurance Companies and HealthInsurance Companies SurveillanceAuthority commence. These bills togetherwould provide for systematic changes inthe organisation and operation of the PHIscheme, with the primary goal of empow-ering insurees and increasing efficiency inPHI spending.

The Bill on Public Health Insurance wouldfurther improve the definition of the BBPby specifying a maximum travellingdistance to general practitioners, specialistsand inpatient facilities, as well as amaximum waiting time for diagnostic andelective health services. In order to makethe system more transparent, patientswould also be able to access a range ofinformation including data on the qualityof health care providers, the performanceof health insurance companies and pricesof alternative treatment options.

The new Bill on Health InsuranceCompanies and the Health InsuranceCompanies Surveillance Authority wouldrequire health insurance companies tooperate as specialised private companiesanswerable to their shareholders andadopting standardised accounting andregulation principles. The bill alsoproposes stricter financial regulation andcontrol of services provided to insurees,for example, monitoring waiting times andensuring access to a network of providerswithin a maximum travelling time.

In summary, there is general agreement inthe country that the health system needssystematic change after years of small adhoc adjustments. Given all the challengesthat the system is facing, beginning this

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The long tradition of local government inFinland seems to be reaching a turningpoint: the government is implementingreforms intended to strengthen themunicipal structure (i.e., increase the sizeof the municipalities), to alleviate equityproblems and to give clients more freedomof choice. The most frequently evincedreasons for these reforms are similar tothose set out in many other Europeancountries - the ageing population, securingsufficient supply and availability in thelabour force, securing the financing ofservices, improving the position ofclients/patients and meet the challenge ofglobalisation. The current reform policypresents itself as a rational reorganisationof service structures and financing. Itssuccess will depend on how well it meetsthe demands and expectations of healthcare consumers, health care personnel andprovider organisations.

In Finland, local health policy decision-making has been decentralised since thebeginning of the 1990s; indeed it is some-times claimed to be the ‘most decentralisedhealth system in the world’. The Finnish

municipalities (431 in 2006 for a popu-lation of 5.3 million; but only 348 munici-palities from 2009), are responsible for theprovision of both health and socialservices, and in this they use their ownlocal tax revenues and are supported bystate subsidies. Hospital services areprovided within twenty-one hospitaldistricts. The financial flows to primaryhealth care, hospital services and socialservices all go through the municipalities.In principle, if maybe not in practice, themunicipalities, with their long and strongtradition of local self government, havebeen important political and managerialdecision-makers in health and socialpolicy. Their position was strengthenedeven further at the beginning of the 1990swith the decentralisation of decision-making on the organisation, extent andcontent of services that they provide. Oneof the arguments for this decentralisationprocess was that of responsiveness: themunicipalities would be able to adjust theirservices to meet local needs and condi-tions. Compared with this, the presenttrend in reforms is just the opposite, backto a more centralised organisation.

Challenges to municipal health servicesSome observers contended that the munic-ipalities, have not in this period beencapable, innovative, willing, courageous orradical enough in their actions. Alterna-

tively, others have argued that they did nothave the necessary political power to fulfilthe expectations imposed on them – toorganise fairly distributed, responsive, effi-cient and financially sustainable health andsocial services. The ongoing reform waveincludes several health and social carestructural and functional programmes andreforms for the whole social securityincome transfer system. In health care thereforms concentrate on municipal localhealth and social services, and in particularon how to strengthen their financial basis.

The challenges faced by the municipalhealth services had culminated in politicaldiscussions concerning two key problems:doubts over the capacity of municipalitiesto finance and to control the rate of growthfor all services, and in particular forhospital services; and secondly, the opera-tional difficulties of local health centres(local primary care units), notably in accessto health centre doctors and in ensuring asufficient level of recruitment to the labourforce. Furthermore, as a whole, theirpublic image is weakening.

These problems have also been recognisedby external commentators: for example,one review by the OECD1 identified aneed to strengthen both the capacity ofhealth centres and improve their efficiency,not only because of financial sustainabilityrequirements, but also to address equity

The Finnish welfare statemeets the consumer society

Hannu Valtonen

Hannu Valtonen is Professor of HealthEconomics, Department of Health Policyand Management, University of Kuopio,Kuopio, Finland.Email: Hannu.Valtonen@uku.fi

process of reform through discussion ofthese proposed laws is important. Whilethe disagreements within both thegoverning coalition and oppositionthreaten the approval of this legislation inits current scope, discussions on these billsshould continue so that, in time, a proposalacceptable to all can be agreed upon. TheCzech health system requires moderni-sation and so does its legislation.

REFERENCES

1. Czech Ministry of Health website.Available at www.mzcr.cz

2. Act no. 20/1966 on care for the people’shealth

3. Czech Ministry of Health. Vecné zámerypripravovaných zákonu [Backgroundanalysis of proposed legislation]. Prague:Ministry of Health, 2008. Available at

http://www.mzcr.cz/Odbornik/Categories/270-vecne-zamery-pripravovanych-zakonu.html

4. Czech Ministry of Health. Vládnínávrhy zákonuk reforme zdravotnictví[Government proposals on health carereform bills]. Prague: Ministry of Health,2008. Available at http://www.mzcr.cz/Odbornik/Categories/848-vladni-navrhy-zakonu-k-reforme-zdravotnictvi.html

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EUROPEAN SNAPSHOTS

concerns. A number of the OECD recom-mendations were directed at developinghealth centres (for example, improvingaccess, expanding the role of nurses tomeet consumer expectations, centralisingthe financing of services, and mergingsmaller municipalities).

The PARAS reform programmeIn spring 2005, the government launched along term reform programme – PARAS(literally meaning ‘the best’). Unlike earlierreforms in Finland, the government hasnot aimed to regulate reform content atlocal level in detail, instead the municipal-ities have been asked to compile their ownplans for the reform of health and socialservices. What is, therefore, new in thisreform process is that central governmentprovides only general guidelines on whatthe municipalities are expected to do.

For example, in primary health careservices and some social services, a lowerlimit for the population catchment servedby one organiser (for example, a munici-pality) is determined (20,000 inhabitants).Central government has left it to thediscretion of the municipalities todetermine how best to meet thisrequirement. Options might includemerging municipalities; creating a neworganisation owned by small membermunicipalities (a federation of municipal-ities); allowing one municipality to provideservices for a number of neighbouringmunicipalities; allowing hospital districtsto organise services, etc.

This approach is unprecedented in thehistory of the Finnish welfare state, wherecentral government has always regulatedservices and structures have been veryuniform, regardless of whether or not thesystem has been centralised or, as from thebeginning of the 1990s, decentralised.After the whole reform process iscomplete, we shall have a welfare statewhich, in an organisational sense, is moreheterogeneous than before.

To a large extent, the PARAS Programmewould appear to be the government’sresponse to the problems of local healthcentres. However, we must ask whetherthese forthcoming changes can save thesepublic health centres? This is what thegovernment is aiming for. In Finland, morethan before, there are both functional andpolitical pressures on public health servicesthat consist of changes in individual needs,expectations and consumption habits. It isnot only that an ageing population can beexpected to increase the demand for health

and social services, but maybe even moreso that the demands on health care arechanging because the expectations ofyounger generations are different fromthose of their predecessors.

Reforms in a consumer societyThe governmental reforms are beingimplemented in a society that can be calleda ‘consumer society’ in health services.Mechanic2 describes this kind of society(his example is the United States) as havingseveral particularly important featureswhich “include belief in marketplacecompetition, choice, activism, techno-logical progress, and consumerism. ManyAmericans, informed by the dominanteconomic paradigm, see health care as nodifferent than other market products to beappropriately allocated through the sameeconomic processes”.

I do not presume to compare the Finnishand US health care systems – the publicfinancing and provision of services inFinland decidedly continues to prevail.But, we are increasingly seeing a consumersociety type phenomenon in our healthcare system. The problem is to reform thewelfare state model to accommodateconsumer society behaviour.

Phenomena indicating the rise of this kindof consumer society in Finland includeincreasing demand for private healthinsurance (especially for children), despite100% coverage by the public services. Inthe long run this can be expected toundermine political support for publicservices, maybe even the whole legitimacyof the welfare state model; after all whypay taxes to finance health services, if thewhole family can have private insurance?Another feature in the changing behaviourof patients is reported by Toiviainen.3 Inher sample “more than half of physiciansconducting patient work reported thatthey (very) often encountered patientswho stated upon arrival for a consultationthat they wanted specific treatments orexaminations, and that the number of suchsituations had increased.”

On the provider side, too, there are somechanges taking place that challenge theFinnish welfare model: the provision ofservices is diversifying. As one result of thePARAS reform in the 2010s, we shall seevarying organisational forms in theprovision of public primary health careservices. In addition, not only the numberof private health service providers, but alsothe number of various providers that arehybrid public/private organisations are

increasing. On the provider side, compe-tition in the health care labour force is alsointensifying. At the same time that somehealth centres are facing shortages in staff,some of these new types of firms havestarted to recruit staff, notably doctors,fromwithin the existing labour force. Oneimplication of this is that municipalitiesmay have to outsource some health centreservices. For doctors however, this offersgreater flexibility in working conditions,working hours and working days, andpotentially also in income, compared withthose traditionally offered by healthcentres.

The crucial question, therefore, that willdetermine the success of the wave ofreforms that have taken place during thepast decade will be whether or not theyhave been a culturally acceptable responseto the new and changing expectations inrespect of both the demand and supply ofhealth care services.

REFERENCES

1. Organisation for Economic Cooperationand Development.OECD Reviews ofHealth Systems – Finland. Paris: OECD,2005

2. Mechanic D. Socio-cultural implicationsof changing organisational technologies inthe provision of care. Social Science &Medicine 2002;54:459–67.

3. Toiviainen H. Konsumerismi, potilaidenja kuluttajien aktiivinen toiminta sekäerityisesti lääkäreiden kokemukset janäkemykset potilaista kuluttajina[Consumerism, patients’ and consumers’active behaviour and, in particular, physi-cians’ experiences and views of patients asconsumers]. STAKES Research Reports160. Helsinki: STAKES, 2007.

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Eurohealth Vol 14 No 4 14

MENTAL HEALTH REFORM

While mental health seldom occupies asignificant space within political debates,increasingly it has featured high on healthpolicy priorities across Europe.1However,mental health systems are very muchcountry-specific and influenced heavily byprevailing societal attitudes towards poormental health. Rapid economic, politicaland social changes in Spain have meant amove away from the conservative societythat existed in 1979 to a liberal democracyover the course of three decades. As aresult, the principles underpinning theorganisation of mental health systems haveshifted away from a reliance on long stayinstitutional care in asylums, where theoverarching concern had been to protectsociety from potential ‘harm’, to a systemwhere the bulk of care is being providedthrough the development of a network ofcommunity based centres to help supportpeople with mental health problems.

One continuing challenge in looking atmental health reform is obtaining data onthe structure of mental health systems.Such data is of highly variable quality

across Europe, making cross-countrycomparisons difficult. One comparativestudy (the ESEMED study) looked atservices in six European countries – Spain,Italy, Belgium, Germany, France and theNetherlands. This study indicated that theprovision of services for people withmental health needs was low in Spain (aswell as in Belgium and Italy).2 Expenditureon public mental health services in Spainremains modest at around 5% of totalhealth care expenditure,3 although there issome significant variation between theseventeen Autonomous Communities(ACs); expenditure in Catalonia, forinstance, has recently been estimated to becloser to 9%.4 No wonder mental healthcare is regarded as the Cinderella of theSpanish health system, namely a secondorder priority and generally among the lastto be reformed.

This article provides an overview of thestate of mental health reform in Spain. Itdescribes the motivation and the process ofdifferent reforms, briefly brings to the forethe most relevant evidence on their conse-

quences, and ends by identifying key areasof policy reform.

A chronology of mental health reformThe 1986 General Health Care Act,charged the National Health System withworking towards both the promotion ofgood health and the prevention of disease.The aim was to achieve equity of accessand help overcome social and geographicaldifferences across the country. Access tohealth care became free at the point of useto all residents of the country (includingundocumented immigrants) and user co-payments were restricted to pharmaceu-ticals. Benefits remain comprehensive,although coverage for some services suchas long-term care and dental services islimited and varies according to region-specific demands.

Today, mental health services, like the restof the health care system, are the responsi-bility of the seventeen ACs. There aretherefore at least seventeen differentmental health plans, each one tackling ACspecific problems, with cross-regionallearning taking place. However historicallymental health had been somewhatneglected; the system relied on the will-ingness of the non-governmental sector,typically religious organisations, to fill thegaps left by the limited, fragmented andpoorly coordinated public servicesmanaged by different administrativebodies.5

New and old challenges in thereform of mental healthsystems in Spain

Joan Costa-Font, Juan Cabases Hita, Jordi Alonso,Luis Salvador-Carulla and David McDaid

Summary: This article provides an overview of the state of mental healthreform in Spain. It describes the motivation and the process of differentreforms, briefly brings to the fore the most relevant evidence on theirconsequences, and ends by identifying key areas of policy reform.

Keywords: Mental Health, Reform, Spain

Joan Costa-Font is Senior Research Fellow and Lecturer, LSE, UK. Juan Cabases Hita isProfessor of Applied Economics, Universidad Pública de Navarra, Spain. Jordi Alonso isbased at the Health Services Research Unit, Institut Municipal d’Investigació Mèdica(IMIM-Hospital del Mar), Barcelona, Spain. Luis Salvador-Carulla is Professor in theDepartment of Psychiatry, University of Cadiz, Spain. David McDaid is Senior ResearchFellow, LSE Health and Social Care and European Observatory on Health Systems andPolicies, London School of Economics and Political Science, UK.Email: J.Costa-Font@lse.ac.uk

A 1983 Ministerial Commission onPsychiatric Reform, followed by thePsychiatric Reform Act of 1985, gave riseto what can be regarded as a modernmodel of mental health care. The Actaimed to guarantee access for people withmental health problems to services withinthe general network of health care, andspecifically within primary care. It alsoredefined the therapeutic meaning ofpsychiatric hospitalisation, which lost itscentral role in psychiatric care. This wascoupled with the objective of providingadequate community services and socialsupports for the rehabilitation and reinte-gration of people with mental healthproblems into the community. Actionswere also envisaged in the community totackle discrimination and protect humanand civil rights. The reforms however onlyfocused on people with psychoses whohad been living in institutions; in fact theyonly make up a fraction of the total popu-lation of people with mental healthproblems at risk of being social excluded.6

Meantime, broad health system reformsintroduced under the General Health Actof 1986 integrated mental health care intothe mainstream health network. Mentalhealth services, with the exceptions ofhypnosis and psychoanalysis, wereincluded within the package of generalhealth services. Moreover a set of specificDiagnostic Related Groups (DRG) weredefined so as to measure activity alongsideother information system improvements.

The reforms helped in the completion ofthe de-institutionalisation process initiatedin the late 1970s, which implied a shiftaway from a system based on old asylumsto one centred on community care, as insome other western countries. Figure 1illustrates the decline in the number ofbeds in psychiatric hospitals over the lastquarter century, being just 39.6 beds per100,000 population by 2006.7

This decline in beds implied the integrationof the mental health system to follow asimilar structure as the rest of the healthsystem, namely an organisation that wouldrely on outpatient, inpatient and resi-dential facilities, as well as multidisci-plinary teams of health and social careresources. Workforce regulation andaccreditation criteria were completelyreformed to include doctors, as well as anew cadre of new mental health profes-sionals, such as social workers and otherhealth professionals, that only recentlyhave been considered of equal value toother professionals within the health

system. Indeed these reforms led to thecreation of a national training programmefor psychiatrists, a network of mentalhealth units to assist outpatient provisionfollowing GP referral, and the addition ofpsychiatric beds to several generalhospitals. Psychiatrist activity ratesexpanded from 3.9 per 100,000 populationin 1982 to 5.12 in 1994. There have beenother newly emerging mental health careprofessionals in the last decade. As of 2005these included: psychiatric nurses (4.2 per100,000 population), neurologists (2.5 per100,000 population) and psychologists (1.9per 100,000 population).

A network of mental health centres eachcovering population catchments ofbetween 200,000 and 250,000 peopledeveloped rapidly. By 1994 there were 550such centres; however, given the devolvednature of the Spanish health care system,the implementation of the reform has beengeographically uneven and there appear tobe marked differences between thedifferent ACs in the availability of servicesdue to differences in regional priorities.

In 1994, a national essential drug therapycatalogue, including treatments for mentalhealth problems was established. A furtherreform under Royal Decree 63/1995defined mental health as a type of‘specialised care’ made of diagnosis andfollow up, drug treatment and individual(group or family) psychotherapy, andpossibly hospitalisation.

Unlike other areas of health care policy,the voluntary sector plays a crucial role inthe provision of community care, to saynothing of the informal contribution offamily carers. When the mental health

service package was updated in 2006(Royal Decree 1030/2006) it madeparticular reference to the role of primarycare in identifying mental health problems,thus further emphasising the communitycare-led model. One of the key challengesthat Spain faces, common to the situationin many other countries, is the lack ofcoordination between different levels ofprimary, secondary and specialist care, aswell as between health and other sectorsincluding social care, in assessing andmeeting the needs of people with mentalhealth problems.

However, it was not until 2007 that theMinistry of Health put forward a workingdocument, the so called ‘Strategy to TackleMental Health’ which contained newclinical guidelines for general practitionersand specialists on the identification andprevention of mental health problems.Similar strategic actions had long been setup for related problems such as theprevention of substance abuse.

The utilisation of services within primarycare remains low in comparison, atapproximately 17% of all those withmental health problems compared with 40-50% in most European countries.8 Thisdoes not simply reflect a lack of demandfor such services, but also is a consequenceof the restrictions in their availability.

Financing and coordinationMental health is financed in the same wayas other health care services in Spain,through taxation supplemented by out-of-pocket expenditure by service users andtheir families. Private insurance does notplay a prominent role. We have noted thatexpenditure on public mental health

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MENTAL HEALTH REFORM

0

20

40

60

80

100

120

140

1980198119821983198419851986198719881989199019911992199319941995199619971998200020022006

Figure 1: Psychiatric beds per 100,000 population, Spain

Source: Spanish Ministry of Health and Consumer Affairs, 2006

services in Spain remains modest at around5% of total health care expenditure3 butthat there can be significant variation inexpenditure rates between the ACs,reflecting the differing levels of prioritygiven to mental health.

Indeed, Salvador-Carulla et al,5 reporthigher mental health expenditure relativeto total expenditure in Catalonia and ahigher absolute expenditure in Navarracompared to Andalucía.

In terms of service mix, as we have alreadynoted, community care services are stilldeveloping, which may explain the greaterreliance on pharmacotherapy relative toother high income countries. While therehas been a significant volume growth in theuse of antidepressants in seven EuropeanUnion countries, growth in Spain is almostthree times that of France.9 Moreoversome non-pharmacological services are notwell covered within the public system, themost notable being psychotherapy which,unlike the situation in Germany and theNetherlands, may only be covered for veryshort periods of time.

We have noted challenges in administrativeco-ordination. Across Spain arrangementsfor managing mental health services canvary considerably, with different degreesof responsibility resting with the ACgovernments, provincial governments andmunicipal authorities. Coordinationwithin and across the health service is thuscomplex and rarely takes place.

Services provided within the health caresystem are also often not well coordinatedwith social care and other relevant sectorsin social policy. The transfer of socialservices to the ACs was completed in 1997but it was only with the completion of thehealth care decentralisation process in 2002that the need for functional coordinationcame to the fore. The shift away frominstitutional to community based care hasbeen markedly uncoordinated with asylumclosures before community services havebeen fully developed.6 Although roughlyhalf of the ACs have set up some mech-anism for coordination, the absence of wellrun coordination between social andprimary care remains the norm rather thanthe exception.

Empirical Evidence

Need for mental health services

Between 5–10% of Spaniards will expe-rience an episode of depression at somepoint during their lifetimes.10 Rates are

much higher in women than in men, withurban residence not seen as a significantrisk factor.11 Rates are lower for peopleaged between thirty and forty-four. Otherprotective factors include being single,employment and a good level of educa-tional attainment.12 Similarly, the results ofthe ESEMED project3 indicate that 19.5%of Spaniards (23% of women and 16% ofmen) experience some mental healthproblem during their lifetimes, with 8.5%experiencing such an event in any one year(11.4% women and 5.3% of men).

Utilisation of services

Spain lags behind Italy, France, Germany,Belgium and the Netherlands in psychia-trists per 100,000 population (only one-third that of Italy and 15% of that France).It has around 50% of the psychiatric bedsper capita available in France.13 About6.4% of adults make use of the health caresystem because of a mental health disorder,of which 21.2% do not receive any specifictreatment.2 Alonso and Haro3 reveal thatroughly one-third of the population havecontacted a mental health professional; thelifetime rate of consultation is about 15%higher than Italy, and similar to that seenin the Netherlands (30%) and France(28%).13 Estimates of service utilisationwere relatively high among those withmental health problems resulting fromalcohol disorders.

Data from a 2006 Eurobarometer surveyallow the comparison of mental healthservice utilisation in Spain with that of theEU average.14 Table 1 reveals thatSpaniards have lower contact rates withtheir general practitioners to discussmental health problems. However, ifcomparing just those who have diagnosedmental health problems, then rates arecomparable to the EU average. Whilst theyare on average less likely to use a phar-macist’s advice, they appear to be morelikely to visit a psychiatrist, especiallywhen experiencing a mental healthproblem. Rates of therapist and psychoan-alyst utilisation are similar to those in theEU as a whole, psychotherapy rates arelower, while contact rates for nursing forthose known to have mental healthproblems are above the EU average.

Appropriateness of care

Another major problem that mental healthsystems must contend with concerns theappropriateness of care, and more broadlyquality. In Spain about 13% of visits toformal care services are made by indi-viduals who do not meet any diagnosticcriteria for mental health problems.15

However, in practice, matching serviceutilisation with need can be complex as thepresence of a mental health disorder doesnot always imply the need for mentalhealth care. In fact, Spain has low service

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MENTAL HEALTH REFORM

Table 1. Percentage of mental health care use in Spain compared to EU average, 2006

Question: In the last twelve months did you seek help from a professional in respect to apsychological or emotional health problem?

EU Spain

AllMental healthproblems

AllMental healthproblems

GP 10.4 17.5 6.3 16.7

Pharmacist 2.0 3.2 0.7 2.1

Physiatrist 1.9 3.3 1.9 5.0

Therapist 1.6 2.7 3.4 2.4

Psychoanalyst 0.1 0.2 0 0.3

Nurse 0.6 1.0 0.1 1.6

Social worker 0.5 1.0 0.1 1.8

Psychotherapist 0.4 0.75 0.2 0.5

Any other professional 2.3 3.83 1.4 3.1

Source: Commission of the European Communities, 2006.14

consultation rates by those without mentalhealth disorders, which on one hand mightbe taken as a measure of appropriatenessof care, but on the other might wellindicate little investment in prevention.15

Key policy challengesOne of the main problems in regulatingmental health services is the greater level ofinformation asymmetries between serviceproviders and those with mental healthneeds. This is in part due to the high levelof prejudice and stigmatisation thatcontinues to surround mental health,particularly in a country like Spain whichhas only begun to modernise relativelyrecently. Furthermore, the important roleof partners and family members inproviding support for people with mentalhealth problems is widely acknowledged.The need to tackle stigma, as well asprevent mental health problems occurring,are key priorities, particularly for thosewho already may be at greater risk ofmarginalisation, including immigrants andthe unemployed. In Spain one surveysuggests that poor physical and mentalhealth can impact on the social activities ofjust over 30% of the population, a ratemuch lower than that observed across theEU as a whole. However, it is complex todisentangle the extent to which thisevidence responds to a lower prevalence ofmental health disorders or, a higher under-reporting of mental health disorders due tostigma.

Of particular importance are populationsub-groups such as children and olderpeople. Children who have parents withenduring mental health problems mayexperience lower quality parenting whichis likely to affect their future life andworking opportunities. Equally, mentalhealth problems observed at school mighthave adverse impacts for crime andincrease the risk of social exclusion. Youngpeople, who may find it difficult to breakinto the employment market due to a lackof experience and qualifications, areanother key group. Young people iden-tified as having psychosis require bothearly health and social care interventionsto prevent and treat potential conditionsthat can result in more severe symptomsand disorders. Another important groupare older people; this is especially relevantin Spain given rapid population ageing. Forolder people poor mental health maycompound existing physical healthproblems and disabilities; it may often gountreated, increasing the risk ofdependency.

Another source of increasing demand formental health services is work-relatedstress. Spain has all of a sudden become‘Europeanised’, leading to a significantchange in lifestyles, especially in workingconditions, some of which might havetransitional costs in terms of stress andadaptation. Another source of increasingdemand for mental health services isunemployment, and Spain has traditionallybeen a country with high unemploymentrates. Finally, another important conse-quence of the westernisation of Spanishhabits lies in the adoption of westernlifestyles and identities, which can beresponsible in some circumstances and insome social groups for increased illegaldrug consumption, as well as an increasingrisk of eating disorders.

As with physical health, there is an incomegradient that explains the influence ofsocial hierarchy in explaining the preva-lence of mental health disorders. This espe-cially is the case for depression.16 Indeed,depression in Spain appears to be moreprevalent among the poorest, even whenincome related inequalities are decom-posed into education and a set of otherrelevant determinants. Among potentialexplanations for this feature is the fact thatthe quality of child care is found not to beindependent of income, and the absence ofan efficient health care network forprevention, diagnosis and appropriatetreatment of mental health problemsamong the less affluent.

Concluding remarksThis article provides a brief overview ofthe organisation and reform of mentalhealth care in Spain, focusing on recentreforms and current challenges. Given thatmental health care does not come cheapand it is far from obvious how mentalhealth programmes are prioritised vis-à-visother health related programmes, reformsshould veer more towards increasing theintegration and coordination of mentalhealth care within health and social careservices. From the existing evidence,further coordination between specialisedand primary care is required and targets forprevention might be set inter-sectorallygiven the existing spillover effects ofmental health problems on other sectors,as well as their impact on physical health.

Ignorance, along with the irrational fearand stigmatisation of mental healthproblems that is common across the globe,goes some way to explaining limited publicsector actions. Mental health services have

paid a high price for not being adequatelyfunded, as the authorities (albeit to a lesserextent after decentralisation), rather thanorganising strong mental health policiesthemselves, have opted instead to shift careto the social arena where it is the subject ofmeans testing.5 Arguably this can be seenas an implicit means of privatisation. Giventhat the priorities for social care differacross the ACs, there is a need for morerobust coordination of health and socialcare. After all, better support for peoplewith mental health problems, it isacknowledged, can in turn reduce the like-lihood of common co-morbid chronicphysical health problems.

REFERENCES

1. McDaid D. Mental health reform:Europe at the crossroads.HealthEconomics, Policy and Law 2008;3:212–28.

2. Alonso J, Angermeyer MC, Bernert S.Use of mental health services in Europe:results from the European Study of theEpidemiology of Mental Disorders(ESEMeD) project. Acta Psychiatrica Scan-dinavica 2004;109(Suppl. 420):47–54.

3. Alonso J, Haro JM. La epidemiología delos trastornos mentales en España: estudioESEMED [The epidemiology of mentaldisorders in Spain: the ESEMED study].Barcelona: ESEMED Project, 2000.

4. Gisbert R, Brosa M, Bohigas L.Distribución del presupuesto sanitariopúblico de Cataluña del año 2005 entre las17 categorías CIE-9-MC [Distribution ofthe public healthcare budget of Catalonia(Spain) for 2005 among the 17 ICD-9-CMcategories]. Gaceta Sanitaria2007;21(2):124–31.

5. Salvador-Carulla L, Garrido M, McDaidD, Haro JM. Financing mental health carein Spain: context and critical issues.European Journal of Psychiatry2006;20(1):29–44.

6. Salvador-Carulla L, Tibaldi G, JohnsonS, Scala E, Romero C, Munizza C. Patternsof mental health service utilisation in Italyand Spain. An investigation using theEuropean Service Mapping Schedule. SocialPsychiatry and Psychiatric Epidemiology2005;40(2):149–59.

7. World Health Organization.MentalHealth Atlas 2005. Geneva: WHO, 2005.

8. Siras Mainar A, Rejas Gitierrez J,Navarro Artieda R, Serrat Tarrés J, BlancaTamayo B, Días Crespo S. Costes y Patrónde uso de Servicios en pacientes quedemandan Atención por problemasmentales en Asistencia Primaria [Costs andpatterns of use of primary care services by

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patients seeking help for mental healthproblems]. Gaceta Sanitaria2007;21(4):306–13.

9. IMS. Antidepressants in the EuropeanUnion. London: IMS, 2002

10. Ayuso Mateos JL. Depresión: unaprioridad en salud pública [Depression: apriority in public health].Medicina Clinica2004;123:181–86.

11. Kovess-Masfety V, Alonso J, de GraffR, Demyttenaere K. A European approachto rural-urban differences in mental health:The ESMED 2000 Comparative Study.

Canadian Journal of Psychiatry2005;50(14):926–36.

12. ESEMeD/MHEDEA2000 Investi-gators. Prevalence of mental disorders inEurope: results from the European Studyof the Epidemiology of Mental Disorders(ESEMeD) project. Acta Psychiatrica.Scandinavica 2004;109(Suppl. 1):21–27.

13. Kovess-Masfety V, Alonson J, BrughaTS, Angermeyer M C, Haro J M, Sevilla-Dedieu. Differences in lifetime use ofservices for mental health problems in sixeuropean countries. Psychiatric Services2007;58(2):1–7.

14. Commission of the European Commu-nities.Mental Well-being. SpecialEurobarometer 248. Wave 64.4. Brussels:Commission of the European Commu-nities, 2006.

15. Alonso J, Codony M, Kovess V, et al.Population level of unmet need for mentalhealth care in Europe. British Journal ofPsychiatry 2007;190:299–306

16. Costa-Font J, Gil J. Would Socio-Economic Inequalities in Depression fadeaway with Income Transfers? Journal ofHappiness Studies 2008 9(4):539–58.

Recent studies, including those of theMental Health Economics EuropeanNetwork, have shown that there are twodominant trends in mental health carefinancing in Europe. The first is a partialshift of funding to the social care andhousing sectors. The second is a liberali-sation of the health care sector and ofhealth care financing as a whole.1,2,3

Specific to the current changes in Dutchmental health care is that the first trend –the transfer of mental health care funds tonon-health care domains – only takes placeat a very limited level. To a much greaterextent, Dutch mental health has becomesubject to a broader liberalisation processtaking place within the health care sector.

Health and social care financingSince 2007 health and social care in theNetherlands have been funded throughthree financing systems (Box 1). The first,the Health Insurance Act (ZVW orZorgverzekeringswet) covers basic,essential health care. The ZVW was intro-duced in 2006 and replaced severalprevious health care insurance systems.The ZVW is the main vehicle for the liber-alisation of health care in the Netherlands.It places a strong emphasis on marketcompetition between insurers, andbetween health care providers. Under thenew legislation all citizens are obliged to

Liberalisation of health care inthe Netherlands:

The case of mental health care

Frank van Hoof, Ineke Kok and Joost Vijselaar

Summary: A process of liberalisation is taking place in health care in the Netherlands. The impact of this process variesover the various health care domains. Mental health care is a domain for which the impact seems to be relatively large.Dutch mental health care is in the process of being transformed from a homogeneous, regionally organised, integratedmental health care system, financed by a single social insurance, to a more heterogeneous working field, financedthrough several sources and subject to market forces. Stakeholders in Dutch mental health care welcome new possibilitiesthis presents for providers, but concerns are expressed about the consequences of these changes for the quality andcomprehensiveness of long term (community) care and for the sustainability of the mental health care system as a whole.

Keywords: Mental Health Care; Financing; Health Insurance System; Deinstitutionalisation Policy; the Netherlands

Frank van Hoof is Senior Research Associate, and Ineke Kok is Head of the Departmentof Mental Health Care Policy and Management at the Trimbos Institute, the NetherlandsInstitute of Mental Health and Addiction. Joost Vijselaar is Senior Research Associate atthe Trimbos Institute and Professor of the History of Psychiatry at the University ofUtrecht, the Netherlands. Email: fhoof@trimbos.nl.

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purchase health insurance for basic healthservices. Consumers are free to choose anyhealth insurer. Health insurers in their turnare expected to compete for clients on thebasis of their premium rates and thequality of contracted providers. Healthcare providers are expected to compete forcontracts with insurers on the basis of theprice and quality of their services.4

The second financing system is the SocialSupport Act (WMO or Wet Maatschap-pelijke Ondersteuning) covering a broadrange of social care domains, such ashousehold support, youth centres, shel-tered accommodation and special trans-portation facilities for people with physicaldisabilities. The WMO was introduced in2007, one year after the implementation ofthe new health insurance legislation. In thisnewWMO system, several previous socialcare laws have been brought together.Under the WMO, local governments arethe administrators of budgets and haveconsiderable autonomy in deciding how tospend these. Budgets in the WMO are notearmarked and there are no individualentitlements. The responsibilities of thenational government are mainly restrictedto decisions concerning the total, nationalbudget for the WMO.

The third financing system for health careand social care in the Netherlands is theSpecial Medical Expenses Act (AWBZ orAlgemene Wet Bijzondere Ziektekosten)covering care for older people, people withdisabilities and, until recently, most of thecare for people with mental healthproblems. The AWBZ is the oldest of thethree financing systems. It was introducedin 1968. The AWBZ is a relatively solidsocial insurance, which places an emphasison strong and precise entitlements to carefor people with more severe or chronic

health problems or disabilities. RegionalAWBZ offices are the administrators of theAWBZ. Unlike the WMO, these adminis-trators perform their role within strict,nationally regulated procedures.

Costs, sustainability and marketcompetitionThe recent reforms in health care financingin the Netherlands are motivated by oneprincipal objective: preserving the sustain-ability of the health care system, or to bemore precise the wish to gain control overthe rising costs of health care. The ZVW is,in fact, the result of a policy process thatstarted around 1990. As a result of thatprocess subsequent government advisoryboards have placed considerable confi-dence in liberalisation as a means ofreaching a more sustainable health caresystem. In line with these views, thecurrent Dutch government places greatconfidence in the ZVW to achieve costreduction and quality gains. The WMO isalso viewed as an important means ofenhancing the sustainability of the healthcare system, albeit in a different way to theZVW. The WMO offers the nationalgovernment the opportunity to controltotal budgets (whereas open-end financingwould lack that opportunity), leaving it toindependent local governments to makeends meet.

In short, at a national government levelthere is much confidence in the ZVW andthe WMO. The concerns of the currentgovernment concentrate on the AWBZ. Itis argued that the costs of the AWBZ arerising too rapidly. In addition, the AWBZ,with its solid entitlements, open-endfinancing and lack of market incentives, isseen as one of the principal threats to thesustainability of the health care system.

Some advisory boards have already arguedfor the abolition of the AWBZ, and thetransfer of its most important elements tothe ZVW and the WMO respectively. Infact, for some AWBZ-financed health careand social care services, these transfershave already taken place. These include thetransfer of the majority of mental healthcare responsibilities in early 2008.

The financing of mental health careOver a period of thirty years, the AWBZhad become the principal source offinancing for almost the entire mentalhealth care system in the Netherlands.During its early years, the AWBZ wasmainly used to fund long term clinical careand long-stay facilities. In trying to reach amore uniform financing system, and tostimulate cooperation between inpatientand outpatient care, outpatient serviceswere incorporated step by step into theAWBZ-system. Since the mid 1980s, inpa-tient and outpatient mental health facilities,including short term mental healthservices, have been fully financed by theAWBZ.

The AWBZ has played an important rolein the development of the current mentalhealth care system in the Netherlands.From a rather patchy network of local,regional and nationally financed facilities,each with its own historical background,methods, and client population, Dutchmental health care has grown over the pastthree decades into a relatively homoge-neous, regionally organised, integratedhealth care system that is clearly delimitedfrom other health care domains.

The fact that all mental health care serviceswere grouped under one financing-systemhas facilitated this development. So did thefact that mental health care was covered bya separate and specific set of entitlementswithin the AWBZ. A national policyemphasising regional cooperation andintegration of mental health care services,alongside the organisation of the adminis-trative management of the AWBZ throughthe regional AWBZ offices, furtherenhanced the regional integration ofmental health care. Ultimately, this inte-gration process culminated in mergersbetween mental health care providers on aregional level. As a result, Dutch mentalhealth care in 2006 was dominated by fortyregionally operating mental health careproviders, each providing the full scale ofmental health interventions (clinical andnon-clinical) for their respective regionalclient populations.

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Box 1: Mechanisms for financing health and social care in the Netherlands from 2007

A new Health InsuranceAct (ZVW)

Covering basic, essential health care; characterised by a central rolefor private insurers, and a competitive market.

A new Social Support Act(WMO)

Covering a broad range of social care domains; characterised by acentral, autonomous role for local government, and the absence ofindividual entitlements or earmarked budgets.

The longstanding SpecialMedical Expenses Act(AWBZ)

Covering care for older people and those with physical disabilities,and until recently most care for people with mental health problems;characterised by well-defined entitlements, little competitiveness, andan administrative role for regional AWBZ offices.

It may thus be concluded that the currentconstellation of mental health care in theNetherlands has largely been the result ofa long lasting and deliberate nationalpolicy. The main objective of that policycould be described as the implementationof a solid, comprehensive, recognisableand accessible mental health care system.The AWBZ was used as an importantvehicle to reach this objective.

Turning pointIt is important to note that the gradualintegration of the mental health caresystem over recent decades has not beenwithout criticism, for example from clientorganisations and mental health careresearchers. Some argued that the devel-opment of a homogeneous mental healthcare sector, clearly delineated from otherdomains, could hamper cooperation withother health and social sectors and the inte-gration of mental health care services inother domains. It was asserted that mentalhealth care might be at risk of becoming aninwardly oriented sector on its own, insuf-ficiently responsive to developments anddemands from the outside. It was alsocontended that the vested interests in thesolidly organised mental health care sectorhampered the deinstitutionalisationprocess and the reintegration of peoplewith long term mental health problemsinto society.5

Until the beginning of this century,however, the positive elements of thesystem were considered by the nationalgovernment to outweigh these concerns.Not only had mental health care growninto a recognisable and accessible healthcare sector, the integration of mental healthcare services also enhanced the compre-hensiveness, continuity and coherence ofmental health care, especially for peoplewith long term mental health problems.While it was also acknowledged that de-institutionalisation was not a speedyprocess, it was also argued that somesubstantial progress was made, be it at acautious pace, in the development ofcommunity based services, housing facil-ities, and rehabilitation and vocationalservices for persons with long termmentalhealth problems. All in all, none of thesubsequent national governments felt aneed for a substantial policy shift.

In 2003, that perspective drasticallychanged. Specifically, the installation of anew government proved to be a turningpoint for Dutch mental health care policy.In the process of preparing the ZVW and

the WMO laws, new policy papers werepublished on mental health care. Thesepolicy papers emphasised the disadvan-tages of a homogeneous mental health caresector, clearly delineated from otherdomains. Concerns were expressed aboutmental health care being run by providersthat operated as regional monopolies,leaving no room for consumer choice. Itwas also stated, that the relatively risk-freefinancing position of mental health careproviders in the AWBZ offered insufficientincentives for innovation. It was concludedthat mental health care would be better offif it could benefit from both the new,competition-oriented ZVW and locallyembedded WMO.6

New incentives and disincentives in theprovision of mental health carePreparations for the transfer of mentalhealth financing were not complete until2007. In early 2007 a relatively smallpercentage (about 3 %) was transferred tothe WMO (subsidies on consumer runprojects, mental disorder preventionactions and outreach programmes forpeople with mental health problems, suchas the homeless). Subsequently in 2008, amuch larger proportion of financing wastransferred to the ZVW. As a consequence,the ZVW has become the main financingsource for mental health care, coveringabout two thirds of expected total mentalhealth care expenses. In particular, theZVW covers all short-term inpatient andoutpatient mental health care, and all long-term community mental health care. Ulti-mately, only long-term inpatient mentalhealth care and institutional housing facil-ities remain within the AWBZ.

The impacts of these reforms in mentalhealth care financing on the structure ofmental health care in the Netherlands aretwofold. First there is the transformationfrom one to (at least) three financingsources. This means that, from thefinancial perspective, mental health carecan no longer be viewed as a single healthcare sector. As a matter of fact, mentalhealth care as such is no longer a delimiteddomain for national policy. No singlegovernment agency any longer holdsresponsibility for the whole of mentalhealth care. Responsibilities are spreadover several departments, with eachdefining and implementing policies on theZVW, the AWBZ and the WMO respec-tively.

Second, market competition is beingrapidly introduced into a field that used to

be determined by relatively secure annualincomes and by efforts to enhance cooper-ation. Specifically, conditions are beingcreated where mental health care providerscan no longer depend on their dominanceon a regional level, and where opportu-nities are rapidly growing for competitionfor market share in other regions.7,8

In short, the incentives contained withinthe new financing structures seem to beleading Dutch mental health care into atransformation process from a relativelyhomogeneous, regionally organised, inte-grated mental health care system (with allits pros and cons) to a more heterogeneousworking field, financed through severalsources, and subject to market forces.

First signs of a new mental health caresystemThe changes in mental health carefinancing are still very fresh and the exactconsequences have yet to be fully grasped.Still, the first signs of these consequencescan be gleaned from the way mental healthcare providers have so far anticipated thenew financing system and from thegrowing discussion on the future of mentalhealth care in the Netherlands.

The first signs from the mental health carefield itself indicate that providers havealready begun competing with each otherfor market share in the provision of short-term mental health care for people withmild mental health problems.

Some providers have begun developingfacilities in the territory of their formercolleague providers – now competitors.Marketing is a rapidly emerging activity inmental health care; new ‘brands’ for short-term care are emerging; and someproviders are actively beginning to explorenew niches in the market. In efforts tofurther ensure a solid market position,mergers are now taking place on an almostmonthly basis.

Meanwhile, the regional organisation ofthe mental health care system is losing itsdominance. Large, nationally operatingproviders are emerging alongside small,specialised, partially commercial mentalhealth care providers. Initial findings alsosuggest that local governments are notalways aware of their new (WMO) respon-sibilities for people with mental healthproblems.9

The new financing system has alsogenerated debate about the future ofmental health care in the Netherlands. Inthese discussions many welcome the new

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opportunities in terms of the diversifi-cation of care products, the emergence ofnew providers and the supposedlygrowing possibilities for consumer choice.

But there are also discussions on the risksof the new system, in particular thoseconcerning the quality of care for peoplewith more severe and/or chronic mentalhealth problems. Although there are as yetno solid empirical data to support theseviews, there are concerns that people withsevere mental health problems maybecome unattractive (costly) clients forinsurers. The new financing system mightthen encourage insurers to disinvest ingood long-term community care.

There is also concern about the dispersionof responsibilities. Some fear that the newsystem carries incentives for local govern-ments and insurers to shift the responsi-bility between each other for the financingof community support and rehabilitationand vocational services. There is alsoconcern that local governments andinsurers will try to shift patients fromWMO and ZVW financed services back tolong term inpatient facilities, financed bythe AWBZ.9 In particular, many mentalhealth prevention programmes andconsumer run projects have been forced toend their activities, as they are not viewedas priorities by local governments.

In short, the first signs of the consequencesof the new financing system for mentalhealth care indicate a growing dynamic inthe provision of short term mental healthcare services and in the market positioningof providers. Clearly at the same time,there are increasing concerns about thepotential consequences for the sustain-ability of long-term, community mentalhealth care services.

ConclusionThe changes in mental health carefinancing in the Netherlands are still verynew. The real impact will become clearover the coming years. For the time beingit seems safe to conclude that, in the slip-stream of a broader liberalisation processof health care in the Netherlands, Dutchmental health care has entered animportant transformation process. Firstimpressions indicate that the new systemhas generated incentives for diversificationand growth of short term mental healthcare, and for strategic manoeuvring ofmental health care providers to strengthentheir market position. Early indicationsalso raise questions as to how thesechanges could facilitate the attainment of

national and international long termmental health care policy goals that havebeen set out in recent decades: deinstitu-tionalisation coupled with the devel-opment of community care and theenhancement of social inclusion of peoplewith severe mental health problems. Infact, it is unclear what value is still attachedto these goals by the current Dutchgovernment.

These impressions lead back to the mainobjective of the current health carereforms: the sustainability of the healthcare system. The supposed cost-reducingmechanisms of the new financing systemmight require time to show and provethemselves. In addition, it is important tobe alert to two possible risks. The first maybe accelerating growth of (mental) healthcare, as a result of incentives within thecompetitive market system for providersto attract (new) clients. Referring topsychiatric epidemiological data, mentalhealth care providers suggest that there isstill a huge reservoir of untreated psychi-atric disorders. Some have now started tosearch more actively for these potentialnew clients. The second risk might be in astagnation of the development of rehabili-tation and vocational services for peoplewith long term mental health problems,resulting in less participation and greatercosts both in terms of social welfarebenefits and impacts on other social caredomains. If these risks are borne out, whathas been intended to be a means topreserve sustainability by reducing costsper product, might then threaten thatsustainability by resulting in growingmental health care consumption and inadditional costs to other publicly financeddomains.

At this moment, however, the speed andthe magnitude of change in mental healthcare financing, and the dispersion ofresponsibilities, mainly seem to lead tofeelings of uncertainty about the futureand to a sense of lack of direction formental health care in the Netherlands. Forthese and the above reasons it would bedesirable for these changes in mental healthcare financing to be accompanied by a newcoordinated national mental health carepolicy, emphasising social inclusion andthe full participation of people with mentalhealth problems.

REFERENCES

1. Knapp M, McDaid D, Amaddeo F et al.Financing mental health care in Europe.

Journal of Mental Health 2007;16:167–80.

2. McDaid D, Oliveira MD, Jurczak K,Knapp M, The MHEEN Group. Movingbeyond the mental health care system: anexploration of the interfaces between thehealth and non-health sectors. Journal ofMental Health 2007;16:181–94.

3. Van Kemenade YW.Health Care inEurope 2007: The Finance and Reim-bursement Systems of 11 European Coun-tries. Maarssen: Elsevier Gezondheidszorg,2007.

4. Bartholomée Y, Maarse H. Healthinsurance reform in the Netherlands.Eurohealth 2007;12(2):7–9.

5. Ravelli DP. Deinstitutionalisation ofmental health care in the Netherlands:towards an integrative approach. Interna-tional Journal of Integrated Care2006;6:1–11.

6. Ministerie van Volksgezondheid Welzijnen Sport. Stappen naar een toegankelijke,betaalbare, solidaire en doelmatige AWBZ[Steps towards an accessible, affordable,solidarity-based and effective AWBZ]. DenHaag: Ministerie van VolksgezondheidWelzijn en Sport, 2003.

7. Van de Pol F. Gereguleerde mark-twerking in de GGZ [Regulated compe-tition in mental health care].MaandbladGeestelijke Volksgezondheid2005;60:1095–107.

8. Hutschemaekers GJM, Tiemens BG. Heteinde van een sectorale GeestelijkeGezondheidszorg: ontwikkelingen, trendsen controverses in Nederland [The end ofsector-based mental health care: develop-ments, trends and controversies in theNetherlands]. Tijdschrift voor Psychiatrie2006;48:27–37.

9. Van Hoof F, Vijselaar J, Fotiadis L,Hasker J. Trendrapportage GeestelijkeGezondheidszorg. Deel 1. Organisatie,structuur en financiering [Trend report onmental health care. Part 1. Organisation,structure and financing]. Utrecht:Trimbos-instituut, 2008.

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It was at a private seminar in Edinburgh in2005, and only after a long day of worthyUK-German comparisons, that a Scottishjournalist saw the point that had eluded thespeakers. Addressing the Germans justbefore dinner he said, “I get it. You thinkthat decentralisation is all about doing thesame thing, but with slight local modifica-tions. We British think it’s about doingdifferent things!”

That journalist was right. The UnitedKingdom has had four politicallyautonomous health systems since 1998,with substantial autonomy and developingpolicy differences. It built them on a legacyof territorial divergence that existed beforedevolution – Northern Ireland, Scotland,and Wales had slightly different policiesadministered by their own health depart-ments despite the overall unity of the UKgovernment. The pressure to match such‘administrative devolution’ with ‘politicaldevolution’, i.e. elected governments, cameabout because of a will to do things differ-ently: a will among Northern Ireland,Scottish, and Welsh political elites to havedistinctive health and other policies; ashared will of their leading parties not to

experience the kinds of policies that UKgovernments elected with English votesimposed on them under the administra-tions of Margaret Thatcher and JohnMajor; and a shared will among elites inBritain to quarantine themselves from thesectarianism of Northern Ireland’s politics.

So eager were the framers of decentrali-sation – ‘devolution’ – to safeguardScottish andWelsh political autonomy, andto quarantine Northern Ireland, that theycreated an extraordinarily loose settlementfor devolution and one that even they nowadmit was not thought through.1 The UK,unlike other decentralised and federalcountries in Europe, does not have ashared statement of values or qualityrequirements. England, Scotland or Walescould abolish their National HealthService tomorrow- in fact, the onlyconstraints on doing so would come fromEU and European human rights law. TheUK does not have shared data require-ments or a shared basket of services or anymechanism to produce them. Financing isnot just decoupled from any specificservices; it is also allocated by the UKgovernment through a formula with nosolid legal basis.

At the same time, there are powerful forcescreating policy divergence in the UK. Firstand foremost, each part of the UK has adifferent political party system. InScotland and Wales, the Conservatives area marginal force. The Labour party does

not just contend with the Conservatives inEngland, who get most of the press; it alsomust struggle for power and votes with thenationalists of Scotland and Wales. And atthe moment those nationalist parties aredoing very well; Plaid Cymru the Welshnationalists are in coalition with Labour,and the Scottish National Party governsScotland. The English Conservatives are tothe right of Labour and never seem quiteable to convince the electorate that theyreally value the NHS model; the SNP andPlaid Cymru are to the left of Labour andaccuse it of faithlessness to the NHS.

As a result of these different party politics,health ministers – who are creatures ofparty politics – make systematicallydifferent decisions. They are aided by thefact that the health policy communities ofthe four systems are very different, withdifferent actors, taboos, social networksand educational backgrounds. Contrast theomnipresent Scottish doctors, Welsh localgovernment, and the English affection forprofessional (and evenNorth American orAustralian) management ideas.

Politicians in the four systems needdistinctive ideas, and their policy commu-nities are ready to supply them. There issome highly visible divergence: Scotlandprovides universal free long-term personalcare for older people, Wales does notcharge for prescriptions, and England hashighly autonomous ‘foundation hospitals’.Some are more nebulous – Wales tried

Devolution and health policy inthe UK

Scott L Greer

Summary: The United Kingdom has not one, but four health systems, and theycorrespond to its four different political systems. Northern Ireland, Scotland,and Wales each have an autonomous legislature that makes health policy whilethe UK government, somewhat oddly, directly runs England’s National HealthService. Each political system has its own party politics and influential policycommunities, and they therefore adopt divergent policies in spite of similarbaselines and public preferences. Many of their future problems, in fact, mightcome from the UK’s poorly defined rules for organising their interactions.

Keywords: England, Scotland, Wales, Northern Ireland, UK, Health Policy

Scott Greer is Assistant Professor ofHealth Management and Policy,University of Michigan School of PublicHealth, Ann Arbor, Michigan, USA.Email: slgreer@umich.edu

hard to improve public health outcomes.

There are indirect distinctions as well; withfour different ministers, four differentbudgets, and four different organisationalstructures, the four health systems producedifferent outcomes measured in hospitalstays or patient outcomes (sadly, usingfour different kinds of data, so comparisonis hard).2,3 Very broadly, the Englishsystem relies on introducing ‘contesta-bility’, to force former monopoly healthcare providers to compete;4 Scotland hasopted for reliance on professionals, lessmanagement, and partnership;5,6 andWales experimented with local work onthe wider determinants of health and onlocal accountability,7 although its newgovernment is advancing reorganisationthat would eliminate much of theconnection of health services with localgovernment. Northern Ireland, wheredemocratic politics fails to provide muchaccountability for public services, is verystable because politicians are not typicallyelected on platforms remotely connectedwith health policy.8,9

The loose, but fragile, institutionalstructure permits this devolution and thedifferent politics provide the energydriving health policy in four differentdirections. The result is a fragile divergencemachine, both capable of creating aremarkable amount of difference in tenyears of devolution, but also easy to breakbecause of its weak institutional base.10 Itproduces divergence despite the great diffi-culty analysts have in finding publicappetite for divergence: the citizens of allfour parts of the UK, when asked, thinkthat social benefits should be the sameacross the whole state, and support thesame (high) levels.11 But politics, of course,often delivers something different fromwhat citizens want.

Fragility of the divergence machineNothing was likely to break the fragiledivergence machine in its first nine yearsbecause Labour was in office, solely or incoalition, across most of the UK, and itspoliticians had both the incentives, theinternal hierarchies, and the back channelsto sort out disputes without thembecoming public. The exception was theNorthern Ireland Executive, where thelocal parties intermittently held power butwere too immersed in their peace processand too underinvested in health policyexpertise to have many opinions. That isdifferent now. The Labour Party is introuble in the UK government (where

English voters are dominant), is out ofoffice in Scotland, and is in coalition withnationalists in Wales who are unimpressedby both English market experiments andthe performance of the existing – Labour-oriented – Welsh health policy estab-lishment.

These changes in party politics revealedweak points of the UK settlement thatacademics had spelled out before.12 The setof issues set out below should not surprisethose familiar with German, Swiss, orItalian health policy, let alone the situationin fractious Belgium and Spain.

Finance

Northern Ireland, Scotland and Walesreceive block grants from the UKgovernment that they can use to spend asthey like and have minimal taxing powers.Not only does this reduce their accounta-bility to their citizens (since they do notraise what they spend); it also givestremendous power to the UK government.This is exacerbated by the peculiar natureof the ‘Barnett formula’ which allocatesnew spending on a strict per-capita basiswithout sensitivity to need. This leavesEnglish per-capita spending lower thanthat of devolved adminstrations.13

Quality standards and coverage

The UK devolution settlement has noshared values, standards, or goals built in.It would be a constitutional challenge tocreate them. This is unfortunate for PrimeMinister Gordon Brown, whose speechesabout “Britishness” incessantly invoke“the” NHS (which has never existed inlaw), along with the BBC, as institutionsthat justify the continued existence of theUK.

Weakly institutionalisedintergovernmental relations

Intergovernmental relations are a blindspot in health policy debates, despite animportance that no sensible analyst ofhealth policy in Spain, Canada, Australia,Germany, or many other countries, woulddeny. Demographics, diseases, or popu-lation characteristics do not matter if thegovernments cannot arrange the laws,financing, and technical skills to makepolicy. In the UK, the problem is that thedevolution settlement scarcely recognisesshared interests, whether in communicabledisease control14 or most other policyareas.15 Governments are flying blind,relying on weak law and personal connec-tions that are becoming rarer and rarer.

EU health policy

The UK devolution law is clear: the UKgovernment is the member state, notNorthern Ireland, Scotland, or Wales, andwhile it should take their views intoaccount, it need not adopt them.16

Scotland and Wales have become influ-ential regional governments in the EUpartly because they worked so well withthe UK, something that depends on a levelof friendship that is already eroding.17 Ifthe UK loses a case against them in theEuropean Court of Justice, the UK pays,but can subsequently claw back thedamages from their budgets (and becauseof that it can intervene to threaten themwhen they pursue policies it thinks mightviolate EU law).

Public acceptance of divergent policy

Do the public, as patients or citizens, acceptdivergence? What parts of the UK’s publicaccept what level of divergence? And willpoliticians make a political point of it? Thepress in each polity tends to present theissue in terms of unfairness measured inspending or services, but there is also a levelof unfairness, often inherited from beforedevolution, in outcomes. Some newspapers(theDaily Mail, the Sun) have already beenusing the inflammatory headline ‘MedicalApartheid’ to discuss cases in whichdevolved health services offer betterservices than the English NHS becausethey claim better per-capita funding.

All of these issues could create a politicalcrisis or, more likely, impinge on thedevolved governments’ ability to pursuedivergent policies. They create incentivesfor politicians to create crises and blameeach other, and leave the UK with fewclear mechanisms to resolve disputes.

Divergent trajectories?Very little public opinion in the UKsuggests support for divergent healthpolicies or outcomes (though, as manyanalysts have pointed out, there has alwaysbeen a high degree of local variation in theactual performance and even services of theNHS in any part of the UK despite publicsupport for unanimity).18 So if publicopinion polls generally show desire for thesame (high) levels of provision, and littlesupport for the idea of divergence in prin-ciple, should we expect learning andconvergence rather than the divergencepredicted by political analysis?

Convergence seems most likely inoutcomes that matter greatly to the public,such as waiting or ambulance response

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times (where England has hit its low targeton elective waits, while targets are easierand less met elsewhere).19 Welsh votersmight be alarmed by their health system,with statistics such as the remarkable 2004survey finding that only 31% of theWelshhealth service leadership said they wouldwant themselves or a loved one to betreated in Wales.20 It is possible to arguethat we have already seen convergence,with limited ‘patient choice’ schemesacross the UK and an emphasis on cuttingpatient waiting times in Scotland andWales. In this reading, devolution wouldmean that Northern Irish, Welsh, andpossibly Scottish voters would be able touse the new democratic accountability oftheir politicians to force standards up. Itmight even mean that the four govern-ments would adopt each others’ successfulpolicy innovations (an argument mademost often, in my interviews and expe-rience, by English policymakers).

But the pressures for convergence, or eventhe pressures for convergence on topicsthat matter to the public such as waitingtimes, are often surprisingly weak. Publicopinion might suggest a focus onproviding the kind of (local, respectful,quality) care that most polls suggest voterswant, but many other things shapepolitical agendas, and they generally havemore to do with party politics and policycommunities than difficult-to-measure anddifficult-to-mobilise public preferences.

The reasons to expect a continued level ofdivergence, on the current coherent trajec-tories, lie mostly in the strategic situationsof political parties. Even if Scotland is nowgoverned by the (minority) government ofthe nationalist Scottish National Party, theswing voters who decide elections remainmuch the same in Scotland, and Scottishpolitics reasonably caters to them. Even ifEngland is currently governed by Labour,the presence of a large Conservative oppo-sition means that the government mustcater to Conservative-leaning voters. Sothose who expected radical change withthe devolved elections of 2007 were disap-pointed; there is a limit to how much evennew parties will change policies.

Health system challenges also limit theradicalism of governments. Health servicesare both easy and hard to change: it is easyfor governments to create a blizzard ofpolicies, but it is also very hard to changetheir underlying nature. English policy-makers have had trouble harnessingmarket dynamics, let alone creating some-thing resembling a market. And that is

despite unprecedented injections of moneyand political effort.

Welsh efforts to turn the focus of healthpolicy from health care to health have alsorun into setbacks since most of the policiesthat improve population health and reduceinequalities are in the hands of otherministers (as with education or transport)or are in the hands of the UK government(as with taxes and benefits). Both Englishand Welsh health policy has drawn backfrom the heights of innovation, while theless novel Scottish system, which harkensback to the NHS systems of 1974–1983, ismuch more politically stable – and that isprobably because it is less of a challenge toprofessional and traditional ways ofworking in the NHS systems.

So if Scottish, or Welsh, or UK govern-ments of any colour and their oppositionspursue much the same voters and the samedistinctive Scottish, Welsh, or Englishpolitical agendas, we can expect furtherdivergence as day to day policies go indifferent directions. But as they, togetherwith the parties in the Northern IrelandExecutive, are constrained by the fragilesystem of intergovernmental relations andtheir various historic legacies, we can alsoexpect that all four of them will continueto find that divergent incremental changeis far easier than systemic reform.

REFERENCES

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2. Greer SL. Territorial Politics and HealthPolicy: UK Health Policy in ComparativePerspective. Manchester: ManchesterUniversity Press, 2004.

3. Greer SL (ed). The Values of theNational Health Services. London: TheNuffield Trust, 2007.

4. Stevens S. Reform Strategies for theEnglish NHS.Health Affairs2004;23(3):37–44.

5. Woods KJ, Carter D (eds). Scotland’sHealth and Health Services. London: TheStationary Office, 2003.

6. Kerr D, Feeley D. Values in NHSScotland: a tale of two C-words. In: GreerSL (ed). Devolving Policy, DivergingValues? The Values of the National HealthServices. London: The Nuffield Trust, 2007

7. Drakeford M. Health policy in Wales:Making a difference in conditions of diffi-

culty. Critical Social Policy 2006;26:543–61.

8. Birrell D. The final outcomes of thereview of public administration inNorthern Ireland. Tensions and compati-bility with devolution, parity and moderni-sation. Public Administration 2008;86(3):779–93.

9. Wilson R, Wilford R. Northern Ireland:polarisation or normalisation? In: Hazell R(ed). Constitutional Futures Revisited.Basingstoke: Palgrave Macmillan, 2008.

10. Greer SL. The fragile divergencemachine: citizenship, policy divergence,and intergovernmental relations. In: TrenchA (ed). Devolution and Power in theUnited Kingdom. Manchester: ManchesterUniversity Press, 2007.

11. Jeffery C. Devolution, public attitudesand social citizenship. In: Greer SL (ed).Devolution and Social Citizenship in theUnited Kingdom. Bristol: Policy, 2009.

12. Trench A (ed). Devolution and Powerin the United Kingdom. Manchester:Manchester University Press, 2007.

13. Heald D, McLeod A. Beyond Barnett?Financing devolution. In: Adams J,Robinson P (eds). Devolution in Practice:Public Policy Differences Within the UK.London: Institute for Public PolicyResearch, 2002.

14. Rowland D.Mapping CommunicableDisease Control Administration in the UK.London: Nuffield Trust, 2006.

15.Greer SL, Trench A.Health and Inter-governmental Relations in the DevolvedUnited Kingdom. London: The NuffieldTrust, 2008.

16. Greer SL.Making European UnionHealth Policy: France, Germany, Spain andthe UK. Buckingham: Open UniversityPress, 2009.

17. Jeffery C, Palmer R. The EuropeanUnion, devolution, and power. In: TrenchA (ed). Devolution and Power in theUnited Kingdom. Manchester: ManchesterUniversity Press, 2007.

18. Powell M. How uniform are uniformservices? Towards a geography of citi-zenship. In: Greer SL (ed). Devolution andSocial Citizenship in the United Kingdom.Bristol: Policy, 2009.

19. Bevan G, Hamblin R. Hitting andmissing targets by ambulance services foremergency calls: impacts of differentsystems of performance measurementwithin the UK. Journal of the RoyalStatistical Society 2009;172(1):1–30.

20. Longley M, Beddow T. NHS WalesBarometer 2004. Pontypridd: WelshInstitute of Health and Social Care,University of Glamorgan, 2005.

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Health is in bad shape in RussiaA decade and a half after the breakup ofthe Soviet Union, the Russian Federationcontinues to exhibit critical healthproblems. Excess or premature mortalityand decreased fertility have produced apopulation decline of 600,000 to 800,000per year net of any in-migration. Theimpact of excess mortality is visited partic-ularly on men and, importantly, on men intheir most productive years. Male lifeexpectancy from birth, which began todecline in the late 1960s, reached a low of57 years in 1995 and generally held steadyat 58 years over the next decade.1,2 Thetwo years, 2006–2007, saw a modestincrease in life expectancy for men andwomen but this did not match themagnitude of the declines of the 1990s.Further, it is not clear that these reversalsof prior trends will be sustained.3

Russia’s population in January 1992 was ofthe order of 148.7 million. On 1 December2005, the population was reported as 142.8million citizens, reflecting an annual loss

rate of 0.3%.1 The underlying causes arestraightforward enough – a disproportionof deaths over births. Reduced fertility andpopulation decline are not unknown inWestern Europe or Japan. However, inItaly, there are 103 deaths for every 100births, while in Russia the correspondingfigures are 170 deaths for every 100 births.The Russian experience has been describedas being without precedent outside ofperiods of war and famine.4

The difference in life expectancy frombirth for males and females is fourteenyears. The principal contributor to excessmortality is acute, life-threatening compli-cations of underlying cardiovascular andcerebrovascular disease – heart attacks andstroke. Cardiovascular mortality for malesin Russia aged 25–64 is four times that inIreland, Western Europe’s highest level.5

The second-ranked contributor is violence– accidents, poisoning and suicide. Formen under 65, Russia’s death rate frominjury and poisoning is four times that ofFinland, the worst record among EUnations, and over twelve times that of theUK.4 A recent United Nations Devel-opment Programme report noted a trendof increasing incidence of ‘external’ orviolence-related causes of mortalityreflecting poverty and marginalisedyounger members of the population.3

The pattern of high, age-standardised male

mortality is relatively uniform among the84 components of the Russian Federation,with the exception of two regions of theCaucasus – Dagestan and Ingushetia. Inaddition, these two regions plus fourteenothers along the southern tier of thecountry are the only components of theFederation exhibiting a positive naturalincrease in population.

The epidemiological basis for the record ofexcess mortality, and acute complicationsof chronic, non-communicable disease, hasimportant implications for appropriateaction. Most important, this record ofcardiovascular mortality is amenable tomedical and public health intervention.Cardiovascular mortality is commonthroughout the world and is an increas-ingly prominent cause of death in tran-sition economies. The twomost importantrisk factors are cigarette smoking andundetected and, therefore, untreatedvascular hypertension. Recognition andappropriate treatment of hypertension inthe US, beginning in the 1960s, and util-ising very simple medications (diuretics),succeeded in reducing cardiovascularmortality by over 60% in three decades.The untreated prevalence of hypertensionin Russia affects approximately 27% of theadult population, similar to that in the US.However, unlike the US where it is esti-mated that 60% of cases of hypertension

Engagement with Russia – notisolation – in the health sector

Edward J Burger and E Wayne Merry

Summary: The health crisis in Russia is of major importance to that countryand to the West. The crisis is real and will not abate without action. The outside world has focusedon infectious diseases in Russia, especially tuberculosis and HIV/AIDS. However, the biggest killerin Russia, by far, is cardiovascular and cerebrovascular disease, especially among men in their mostproductive years. There exist proven solutions for these killers and some successful experience incooperation in the health sector. This is a very good place for the new Russian and Americanadministrations to start in repairing the relationship, in both our interests. There is a tangiblecontribution that can be made to Russian health and, ultimately, to the devastating demographicdecline in Russia. We need to reverse the current trend toward re-isolation of Russia. Medical andscientific cooperation has an exceptional opportunity to contribute to re-engagement.

Key words: Russia, demography, cardiovascular disease, foreign policy

Edward J Burger is Director, EurasianMedical Education Programme of theAmerican College of Physicians, Wash-ington D.C., USA. E Wayne Merry isSenior Associate, American Foreign PolicyCouncil, Washington D.C., USA.Email: ejburger@worldnet.att.net

are recognised and placed under treatment,only 8% are in Russia.5

There has been significant foreignattention in recent years to infectiousdisease in Russia, especially tuberculosis(TB) and HIV/AIDS. The burden of thesediseases is certainly very important. TBhistorically has been considered a diseaseof older people, but in Russia, the meanage of patients began to drop in the 1990s.By 1994, 40% of TB deaths occurredamong patients younger than 39.6 Thedisease now disproportionately affectsyoung adults, particularly men.7 All threedisease entities, myocardial infarctions andstroke, TB and HIV/AIDS, have theirgreatest impact on men in their mostproductive years. However, cardiovascularmortality in Russia overwhelms that fromthe other two diseases combined8,9 – anyserious effort to arrest the demographicdecline in Russia demands a concentratedattack on this disease.

The Russian health and mortality record isparadoxical in that it is generally believedan improving economy brings with itcommensurate improvement in the socialand health status of its citizenry.10 The levelof economic activity has risen at annualrates of 6% to 8% over the past four yearsdespite the continued drop in population.Despite these indices of economic progress,they have not caused ‘all boats to rise’.Russia has shown a slight gain in fertilityand a modest decrease in infant mortality.11

However, the record of markedlydepressed early adult mortality, whilemodulated slightly, remains exceptionallyhigh, notably for working-age men.3,4

Consequences of continuation of thepresent courseIf Russia is unable to alter the presentdemographic decline, the consequences aredire. The US Census Bureau’s ‘optimistic’projection is for a reduction of ten millionin the Russian population between 2000and 2025. The United Nations PopulationDivision ‘medium variant’ projection,suggested a drop of more than twenty-onemillion over the same period.4 A recentUNDP review of demographic trends inRussia predicted a need for 22million addi-tional workers by 2023.4 In-migration ofRussians to the Russian Federation fromother parts of the Former Soviet Union,the hoped-for safety valve to counter thelarge negative natural increase at home, hasslowed to a trickle. At the same time, out-migration of Russians continues. Internalmigrations are also altering the country’s

demographics, most dramatically in theRussian Far East with a loss of populationat a rate much higher than that experiencedby the nation as a whole.

By 2015, the cohort of eighteen year oldmen will number 600,000 to 650,000 andbe insufficient both to serve in the militaryranks and to enter university at presentlevels.12 Indeed, today’s conscription rateswould exceed the total cohort of eighteenyear old men at that time. Theseconscription rates will increasingly conflictwith the imperative that many young menpursue higher education.

A reduction in the flow of students intohigher education will threaten the abilityof the nation to reach its full economicpotential. The current economic base isheavily dependent on a single sector –extractable resources, most notably oil andgas. For 2003, the US Central IntelligenceAgency estimated that over 80% ofRussian exports were derived from sales ofenergy resources, timber and metals. Thus,the overwhelming majority of the Russianwork force contributes only 20% to thenation’s export earnings. In Ireland, thecomparable value of non-resource exportswas about 150 times as much on a percapita basis. Global competition increas-ingly requires higher value-added contri-butions which necessitate an educatedwork force. Thus, Russia’s economycannot diversify beyond the limitations ofits current commodity export structureunder the projected demographicconstraints.

Continued improvement of the economywill depend on both the number ofworkers available and the quality andhealth of that work force, both of whichare currently compromised. The WorldBank estimates that the combined cost toRussia of deaths from heart disease, strokeand diabetes on labour supplies andsavings at $11.1 billion and suggests thatthis figure could rise to $66.4 billion in2015, ten times the corresponding estimatefor the UK.9 Translating these losses into apercentage reduction of gross domesticproduct (GDP) would mean a reduction of1% in 2005 rising to over 5% by 2015.9

A significant level of immigration of non-Russians is required to compensate fordeclining population numbers and to meeteconomic and security challenges. In fact,that trend is already underway. Russian oiland gas companies employ large numbersof non-citizen workers, especially fromCentral Asia. In addition, even without

immigration, the Russian population willbecome decreasingly Russian, Slavic andOrthodox due to a combination ofcontinuing out-migration of highlyeducated Russians and inward migrationof low wage personnel from elsewhere inthe Commonwealth of Independent Statesand beyond.12

A federal programme was announced tobegin in 2007 to encourage immigration ofup to one million individuals to helpcompensate for Russia’s demographicloss.13 The programme will cover the costof resettling immigrants, provide loans andoffer unemployment benefits for up to sixmonths. The programme spokesmanannounced that he expected most immi-grants to come from countries with a“...large workforce but unstableeconomies.” In a similar vein, inNovember 2003, the Federationgovernment issued rules that made itpossible for foreigners to serve in the RedArmy and ultimately earn citizenship fortheir duty14 (although, reportedly, only300 foreign workers are currently servingin the Russian military).

Immigration, to a great extent, impliesimmigration by individuals from MuslimCentral Asia and China in the Far East.The number of Chinese who have actuallymigrated to Russia appears to be relativelysmall, although fear of that migratorytrend is very high. Immigration ofMuslims is more complicated. EthnicMuslims already constitute just over 10%of the total population and 9.5% of themale population. The percentage ofMuslims of conscription age is slightlyhigher (10.07%) and promises to risefurther at a time when the absolutenumbers of 18-year old males will beunusually low.

Importantly, Muslims in Russia tend tohave a higher fertility rate and greaterlongevity than Slavic Russians. Thoseliving in the predominately Muslimregions of the Southern Federal Districtare more likely to have been in highereducation compared with Russian males ingeneral but they are more likely to beunemployed.15 By some estimates, 14 to 23million Muslims live in Russia16 andMoscow already contains two and a half tothree million Muslims. In 2004, 45% oflive births in Moscow were to parents ofethnic Muslim origin.17 In the long run,diversity is desirable. In the immediatefuture, and in the face of economic slowdown, the implications for social insta-bility within the multi-ethnic and multi-

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confessional Russian Federation are fearedto be adverse and serious.

The trend toward re-isolation. The casefor engagementAlexei Arbatov, Scholar-in-Residence,Carnegie Moscow Center, in a thoughtfuldisquisition on US-Russian relations,warns of the possibility of Russia’s movingtoward a “...neo-isolationist foreign policyfocusing only on ensuing transient andacceptable prices for oil and gas exports,and selling weapons, nuclear materials andnuclear technology to any prospectivebuyer.”18 There is no argument that US-Russian relations have deteriorated overthe past few years. A recent report of aCommission on Smart Power by theCenter for Strategic and InternationalStudies labelled US-Russian relations“chillier than they have been at any timesince the end of the Cold War.19 DmitriTrenin of theMoscowCarnegie Center hasdescribed the current atmosphere as“toxic.”20

Isolation, of course, was a feature of mostof Tsarist Russia’s history. Seventy years ofCommunism furthered the trend. Yet, it isprecisely this aspect of isolation which isin the interest of neither Russia nor theWest. Former US Senator Gary Hart,wrote that “an isolated, anti-democraticRussia increases our insecurity. Russia’sdevelopment as a market democracy willbest be achieved by engagement, notrejection.”21

The health sector, as singled out by theCommission on Smart Power, presentsparticular opportunities for cooperation.This focus on health properly comple-ments other key elements of foreign policy,such as economic development andsecurity, and merits a similar level ofattention. As a report from the Council onForeign Relations noted, the rationale forthis position includes a combination ofboth humanitarian and good leadershipqualities, on the one hand, and self-interests on the other.22

We are inevitably anxious about thespectre of infectious disease such asHIV/AIDS and TB, including drug-resistant TB, intruding on our shores. Thefear has justification in the face ofepidemics abroad, the mobility of peoplesand the use of rapid and dense mass trans-portation. For example, the transitoryepidemic of TB in New York City fifteenyears ago, and its lower but still evidentprevalence there now, are in part attrib-utable to travel and immigration from high

TB areas of the former Soviet republics.

However, our broader self-interest derivesfrom the recognised relationship betweensocial well being and health, on the onehand, and political stability and economicdevelopment on the other. Health bothinfluences and is affected by economicdevelopment. Health is both an economicinput and an output. A high prevalence ofdisease and disability, coupled withreduced longevity, compromises economicproductivity and the contribution of theworkforce to the economy through labourshortages and absenteeism.

What is the interest of the West?In the views of these authors, we in theWest have a self-evident interest in thepreservation of a stable Russia and in thepromotion of a healthy and prosperousRussian nation. Unfortunately, thelegacy ofWestern assistance to post-SovietRussia is very mixed. Far too manyprogrammes and Western participantsapproached Russia as a laboratory for theirsocial and economic theories, knew littleabout the country or were unwilling tolearn, and dealt with Russian counterpartson a basis of condescension and sermon-ising. Many of those programmes werefocused inappropriately on economics oron societal transformation.

In contrast, an early (1992) well-conceivedand successful programme was theHospital Partnership Programme whichlinked twenty-six US institutions and acorresponding number of medical centresin the Former Soviet republics. Unfortu-nately, the programme was later substan-tially altered from its original conception.What followed was a very weak, discon-tinuous effort characterised by short-term,ever-changing goals. For the past fifteenyears, there has been a lack of any coherentstrategy for health cooperation and assis-tance with Russia. That lack of coherentdirection has led to a large universe ofprivately supported and initiated projects,led by a variety of non-governmental andfaith based groups. All of these have beenwell intended but have varied in quality andbeen episodic in character.

Precedents from the past – the exampleof Latin AmericaThere are some highly successful examplesof past initiatives in which health has beenused explicitly as an instrument of foreignpolicy. In 1942, Nelson Rockefeller,impressed with the importance of health asa vital element in Latin American social

and economic development, and with thestrong support of President Roosevelt,established a quasi-governmental corpo-ration, the Institute for Inter-AmericanAffairs, devoted to health and medicineassistance for eighteen Latin Americannations. The extra-governmental formwaschosen explicitly to allow for flexibility, toencourage contributions by professionalsfrom the academic and foundationcommunities (especially the RockefellerFoundation) and to avoid the burdensomerestrictions of normal US governmentalregulations. The US committed itself to along-term project with a set level offunding. The understanding in all caseswas that the host Latin American countrywould eventually assume 100% of the cost.

The programme was extremely successful.From the beginning, it worked closely withhost governments. It enjoyed a substantialcontinuity and longevity, coming to an endonly in 1958. The programme, in collabo-ration with the Rockefeller Foundation,built hospitals, nursing schools, healthclinics, supported training programmes forvisiting nurses and health educationprogrammes for the general public. Amongits most important characteristics werecoherence of effort, the continuity of long-term dedication, a strong element ofprofessionalism and a sense of partnershipand cooperation rather than a donor-recipient relationship.23

The scale and creativity and the resultantquality of professional contributionsinvolved contrasts sharply with the presentportfolio of foreign assistance programmesfor health in Russia. Fortunately, there is alegacy to build on. Some of the mostconsequential interactions to date havebeen in the fields of science and medicine.Borrowing from past experience, weshould emphasise the key role of profes-sional exchanges. These not onlycontribute to social and healthimprovement but represent highlyeffective vehicles for public diplomacy andsoft power. However, the key is part-nership, not assistance. During the courseof the earliest exploratory mission ofAmerican medical professionals to theformer Soviet republics following thebreakup of the Soviet Union, a visitingdelegation was offered the advice,“…diminish foreign assistance but help ushelp ourselves.”24

Some principles for effective cooperationA successful cooperative health programmeshould focus on projects which promise

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real benefits to health. In practice, thismeans a focus on those diseases which arethe most prominent contributors toRussian premature mortality – heartattacks and stroke. The death rate fromcardiovascular disease is more than tentimes greater that from AIDS, TB andmalaria combined.25 As noted above,premature deaths from these causes arepreventable and trends can be reversed. Asecond important principle is continuity ofeffort. To be effective medically and to earnthe collaboration of the professionalmedical community in Russia requiresinvestment sustained over an appropriatelylong period of time without abrupt changesin direction and priority.

A third important principle is insistence onprofessionalism in the design andperformance of cooperative efforts. For anumber of reasons, USAID in recent yearshas turned to large private contractors toundertake development and assistanceprojects. While this has, perhaps, addedadministrative and economic efficiency toassistance efforts, those projects designedto improve health have often lacked theknowledge and talent of professionalmedical institutions and individuals whoare recognised for their scientific prowessand know the territory. Susan Raymond,currently Executive Vice President to thecompany Change Our World Inc., whichprovides advice to global non-govern-mental organisations and foundations, inan advisory report to the Administrator ofUSAID a few years back, emphasised thispoint in a strongly worded report. Sherecommended “…a strategy that drivesaway from reliance on third partycontractors for portfolio development, andtoward institutions that share the problemsand potential gains from addressingproblems/opportunities (for example,professional associations)”.26

The vast majority of the Russian medicalprofession was isolated from Westernmedicine and medical science for seventyyears. The legacy of this professionalisolation itself presents an opportunity toshare knowledge, skills and experiencewith colleagues throughout the world.Programmes such as the ten-year EurasianMedical Education Programme of theAmerican College of Physicians haveproven the effectiveness of professionalmedical education exchanges to increasethe capacity of the Russian medicalprofession to prevent and manage seriousdisease. The investment is small but highlytargeted and the leverage is large.

The opportunity may be nowFormer President Putin highlightedRussia’s demographic decline in successivespeeches to the nation and Duma duringhis term in office.27 In each instance, Putinused the weight of his office to emphasisethe importance of the issue. He usedphrases such as “…the most serious threatto the country…” and “…one of the mostacute problems.” From time to time, otherRussian spokesmen have taken visiblenotice of demographic loss.28 InSeptember 2005, Sergei Mironov,Chairman of the upper house of theparliament, told a meeting of Russia’s LifeParty that “…from a demographic point ofview, there is no great difference betweenthe Civil War including collectivisation,the Great Fatherland War (World War II),and the end of the 20th century.”

However, only recently has the ‘warningfrom the top’ been followed by tangiblegovernmental actions and the allocation ofnew funds. In his 20 June 2006 address,President Putin announced a pro-natalistprogramme of subsidies to encourage childbearing.27 Perhaps the most tangibleproposal was the Kremlin’s announcementin 2006 of a series of four ‘nationalprojects’ devoted to improvements inhealth care, education, housing policy andagriculture.29 The President announced thecommitment of 195 billion roubles ($6.9billion) per year to the ‘demographicproject.’30 Cardiovascular disease was thesubject of prominent concern and, for thefirst time, the Russian FederationMinistryof Health and Social Developmentconsidered the issue of tobaccoconsumption in Russia.31 Perhaps mostimportant was the appointment of DmitriMedvedev, then Deputy Prime Ministerand now President, as the overseer of thesenational projects.

The new opportunity for cooperationcomes from these indications that Russiahas begun to take the health and popu-lation problem seriously and from theapproaching political changes in Wash-ington and recent changes inMoscow. The‘honeymoon’ period for the two new pres-idents will present opportunities to re-engage the troubled relationship. There isno better field for productive cooperationthan health care. The American side shouldtake the initiative, but we should seekprojects and programmes marked byprofessionalism and collegial partnership,and move away from traditional foreignassistance whose hallmarks are ‘donors’and ‘recipients’.

REFERENCES

1. Eberstadt N. The Russian Federation atthe dawn of the twenty-first century:trapped in a demographic straightjacket.NBR Analysis, National Bureau of AsianResearch 2004;15(2):September.

2. Field MG. The health crisis in theFormer Soviet Union: a report from the‘post war’ zone. Social Science andMedicine 1995;41(11):1469–78.

3. Yelizarov V, Arkhangelsky V, Ivanova A,Chudinovskikh O, Misikhina S. Demo-graphic Policy in Russia: From Reflection toAction. Moscow: United NationalDevelopment Programme – Russia, 2008.Available at http://europeandcis.undp.org/home/show/9EB5B2A6-F203-1EE9-B5423E1B114A6425

4. Eberstadt N. The Demographic Factor asa Constraint on Russian Development:Prospects at the Dawn of the Twenty-FirstCentury. Chapter prepared for a volumeedited by Eugene Rumer and CelesteWellander (unpublished). Washington,D.C., 2004.

5. Arbidze GG, Arabidze GrG. Antihyper-tensive therapy. Kardiologiya 1997;3:88–95(in Russian).

6. Migliori GB, Khomenko AG, Punga VV,et al. Cost-effectiveness analysis of tuber-culosis control policies in Ivanovo Oblast,Russian Federation. Bulletin of the WorldHealth Organization 1998;76(5):475–83.

7. The Global Impact of Drug-ResistantTuberculosis. Boston, Massachusetts:Harvard Medical School/Open SocietyInstitute, 1999.

8. Leeder S, Raymond S, Greenberg H. ARace Against Time. New York: TheUniversity of Sidney, The Earth Institute atColumbia University and the MailmanSchool of Public Health, 2004.

9. The World Bank. Dying Too Young.Addressing Premature Mortality and IllHealth Due to Non-communicable Diseaseand Injuries in the Russian Federation,Europe and Central Asia. Washington,D.C.: World Bank, Human DevelopmentDepartment, 2005.

10. Kuhn CJ. Commentary: mortalityincreases during economic upturns.International Journal of Epidemiology2005;34(6):1206–11.

11. RAI Novosti. Russia’s Infant Mortalityon the Decrease. Moscow, 14 November2006.

12. Balzer H. The Implications of Demo-graphic Change for Russian Politics andSecurity. Paper presented to a Conferenceon Health and Demographic Decline in theStates of the Former Soviet Union.

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The health care system in Turkey has beengoing through a series of crucial reforms inrecent years. The most tangible steps inthis reform process were launched after theJustice and Development Party (AKP)emerged as the ruling party in the electionsof 2002. The EU accession and harmoni-

sation process has also provided additionalmomentum for implementation of changein the health care system. Thus one of thefirst political decisions the AKP took wasto launch the Health TransformationProgramme* (HTP) in 2003.

The overarching objectives of the trans-formation programme were firstly toreduce inequalities in access to health carewithin the country and secondly to narrowthe gap in the utilisation and quality ofhealth services observed in Turkeycompared with other middle-income, aswell as EU, countries.1 The specific objec-

Health care and pharmaceutical policiesin Turkey after 2003

Nebibe Varol and Omer Saka

Summary: The health care system in Turkey has been going through a series of crucial reforms in recent years.The most tangible steps in this reform process were launched after the Justice and Development Party (AKP)emerged as the ruling party in the elections of 2002. The EU accession and harmonisation process has alsoprovided additional momentum for implementation of change in the health care system. This article assesses theextent to which actions to date are consistent with the objectives of the reform programme launched in 2003.

Keywords: Health System Reform, Pharmaceutical Policy, Turkey

Nebibe Varol is reading for a PhD, LSE Health, London School of Economics andPolitical Science and Omer Saka is Health Economist, Division of Health and Social CareResearch, King’s College, London. Email: n.varol@lse.ac.uk * Also known as Health Transition Project

Cambridge, Massachusetts: Davis Centerfor Russian and Eurasian Studies, HarvardUniversity, 29–30 April 2005.

13. Yublakova O. Kremlin seeks 1 millionmigrants.Moscow Times 3 July 2006.

14. Russia opens up armed services toforeigners: the pros, cons of volunteersoutlined. Isvestiya 14 November 2003 (inRussian).

15. Twigg J. Differential Demographics.Russia’s Muslim and Slavic Populations.PONARS Policy Memo #388, Center forStrategic and International Studies, Wash-ington, D.C., 9 December 2005.

16. Schwartz M. With an assist fromMoscow, Islam flourishes. InternationalHerald Tribune 17 December 2007.

17. Goble P. A Mosque in Red Square.Presented to a meeting of Radio FreeEurope, Washington, D.C., 28 February2006.

18. Arbatov A.Moscow and Munich: ANew Framework for Russian Domestic andForeign Policies.Working Papers No. 3.Washington, D.C.: Carnegie Moscow

Centre, Carnegie Endowment for Interna-tional Peace, 2007.

19. Center for Strategic and InternationalStudies. CSIS Commission on SmartPower. Washington, D.C.: CSIS, 2007.

20. Trenin D. Russia’s Strategic Choice.Policy Brief 50. Washington, D.C.:Carnegie Endowment for InternationalPeace, 2007.

21. Hart G. Don’t lose Russia. TheNational InterestMarch–April 2007.

22. Kassalow JS.Why Health is Importantto US Foreign Policy. New York: Councilon Foreign Relations, 2001.

23. Rowland D.History of the Coordinatorof Inter-American Affairs, HistoricalReports on War Administration. Wash-ington D.C.: US Government PrintingOffice, 1947.

24. Medical Working Group, Experts Dele-gation to the New Independent States.Report presented to the CoordinatingConference on Assistance to the New Inde-pendent States, Lisbon, 23–24 May 1992.

25. World Health Organization.

Preventing Chronic Diseases: A VitalInvestment, Geneva: WHO, 2005.

26. Raymond S.Health Assessment/Natsios Report (unpublished), 29 January2002.

27. Putin VV.Opening Address by the Pres-ident to the Federation Security Council.Moscow, 20 June 2006.

28. Goble P. Window on Eurasia: Russia’sdemographic problems need compre-hensive approach. Johnson’s List 27September 2005.

29. Korchagina V. Putin spells out purposeof social plan.Moscow Times 30 November2005.

30. Summary Report. A Meeting of theSecurity Council Devoted to Measures toImplement the President’s Address to theFederal Assembly. Moscow: The Kremlin,20 June 2006 (unpublished).

31. Announcement of a Working Group onthe Problems of Tobacco Consumption forthe Ministry of Health and Social Devel-opment. Moscow: Ministry of Health andSocial Development, 20 September 2006.

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tives of the HTP are outlined in Box 1.2

The article assesses the extent to whichactions to date are consistent with thesestated objectives.

Restructuring of the MoH for effectivestewardshipThe main components of the reformagenda include restructuring of theMinistry of Health (MoH) to encouragedecentralisation, establish monitoring andevaluation capacity and ensure the qualityof health care services. The MoH hastransferred responsibility to the provincialauthorities on the opening and closure ofpharmacies, as well as for the monitoringof marketing and consumption of pharma-ceuticals. In addition, decisions regardingextra working hours and transfer of healthpersonnel between provinces, and thecareer progression of health personnelaccording to performance criteria are alsonow to be taken at the provincial level. Asyet however, the necessary legislativechanges have not been completed.

In a related aspect of reform, the Directiveon Institutional Performance and QualityDevelopment has been issued and aQuality Coordination Unit establishedunder the MoH as the responsibleauthority for quality management inhospitals and other institutions thatprovide health care. The performance ofhospitals is now evaluated through inspec-tions undertaken in accordance with thisdirective.3

Establishment of a Universal HealthInsurance FundAnother element of reform has been tosupport the establishment of a universalhealth insurance fund through the consol-idation of different health insuranceschemes* under one umbrella to ensureequity of access to services. The mostimportant recent developments in Turkishsocial policy have been the enactment,despite much heated debate, of both aSocial Security and General HealthInsurance Law and Social Security Insti-tution Law in 2006.4 The new systemembraces all social groups, including indi-viduals not formally employed, and aimsto facilitate universal access to health careservices. Different reimbursement mecha-nisms employed by different socialsecurity institutions have been replaced byone model following enactment of theGeneral Health Insurance Scheme (GHIS)by the Turkish Parliament in 2006.

Since January 2007, no payment isrequired for primary health care services,even if an individual is not covered by asocial security scheme. Rejections, due todifferent insurance or payment processes,have been eradicated for emergency admis-sions in all health care institutions.4 Indi-viduals below the age of eighteen are

covered by the health insurance schemefree of charge. Considering the extent ofchild poverty in Turkey (according to theTurkish Statistical Institute approximately5.7 million children under the age of fifteenwere living in poverty in 2004), thisprovision is extremely significant in thecontext of the Turkish health care system.5

The Green Card Scheme, which helpscover health care costs for those livingbelow a state determined poverty line, wasextended in 2005 to cover all health careexpenditure (previously outpatient careand prescriptions had been excluded)which facilitated the access of the poorestsegments of the society to health care.Currently Green Card holders are fullycovered, with the exception of a 20% co-payment for prescriptions. Access to medi-cines for SSK andGreen Card beneficiarieshas been improved by granting them theright to obtain medicines from all privatepharmacies instead of the limited numberof specified pharmacies that had providedthis service in the past. Similarly, privatehospitals can now be reimbursed for healthcare services provided to individualscovered by the public insurance scheme.

Reorganisation of health care servicedeliveryReform measures have included theadoption of family medicine for theprovision of outpatient or primary healthcare services, the integration and harmon-isation of MoH and SSK hospitals, as wellas the further development of services forthe prevention and control of non-communicable diseases and the intro-duction of more effective maternal andchild health interventions.

In November 2004, Parliament approvedlegislation to pilot a new family practi-tioner scheme. Implementation initiallybegan in Düzce province, with the aim ofextending the scheme to the whole countryby 2008. Currently nine million people canavail themselves of the family practitionerscheme, which has been rolled out to theprovinces of Eskişehir, Gümüşhane,Edirne, Bolu, Adıyaman, Elazığ, Denizli,Isparta, Samsun and İzmir. The intro-duction of the scheme has also beenaccompanied by a decrease in the numberof patients presenting to secondary andtertiary care facilities. While the number of

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Box 1: Stated objectives of the 2003 Health Transformation Programme

Restructure the Ministry of Health to facilitate more effective stewardship and policy making

Establish a universal health insurance fund to ensure equity and access to health services

Reorganise health care provision so as to separate service delivery from financing in order toachieve a more efficient resource allocation

Introduce family medicine to integrate and streamline the delivery of primary care with inpatientcare

Ensure financial and administrative autonomy for all hospitals to improve technical efficiency andstrengthen management

Set up a fully computerised health and social care information system

Encourage the private sector to invest in the health care sector

Improve maternal and child health

Eliminate shortages of health personnel in areas earmarked as being priorities fordevelopment

* Social Insurance Organisation (SSK), the Government Employees Retirement Fund(GERF), the Social Insurance Agency of Merchants, Craftsmen and the Self-Employed(Bag-Kur) and Green Card Scheme.

contacts with primary care have increasedby 37% from 1.7 to 2.3 million, referrals tohospital from primary care have alsodecreased.6 In addition, community healthcentres have also been established tofurther increase access to effective primarycare services and monitor family practi-tioners. They also provide logistical freesupport for vaccination campaigns, as wellas mother and child care and familyplanning services.

We have noted that all SSK and otherpublic hospitals, previously not under thecontrol of the MoH have now been trans-ferred to the MoH. Thus the MoH is nowthe principal actor in health care provisionfollowed by the university teachinghospitals. Another welcome improvementin legislation governing health careprovision now permits state hospitals touse their own revenues to purchaseselected services from private providers.This has resulted in a better use of alreadyestablished but underutilised privatehospital capacity. The relative workloadsof the public and private health care facil-ities have also improved since privatehealth care facilities now provide service toindividuals covered by public insurance.More responsive management structureshave also evolved as a result of theincreased autonomy of public hospitals.One example of such managerial inno-vation that we can point to is the estab-lishment of data processing infrastructuresin most hospitals in recent years.

Performance-based additional payment topersonnel from revolving funds

As part of the HTP objectives,performance indicators were developedand performance-based payment systemswere established. Performance-basedrevolving fund payments which link therevenue of hospitals to the hospitalpersonnel payment schemes have resultedin the voluntary extension of workinghours by hospital personnel. Financialincentives have driven most specialists toclose their private offices and start workingonly in hospitals, which in turn hasrelieved patient overload in hospitals. Suchpolicies have increased the proportion ofpractitioners working full time in thehospital system from 11% in 2003 to 60%in 2007. The effectiveness of patient regis-tration systems have also increased due tothe introduction of the performance-basedsystem. Currently all hospitals have estab-lished electronic database systems: beforethe reform process only 20% of hospitalshad this capability.

Building a health information systemThe Health Transformation Programmeemphasised the need for better qualityinformation to make sound health systempolicies and administrative decisions. Thecreation of health information systemsrequires both the integration of dataobtained from different institutions and itspackaging in a format amenable to use indecision making processes.

Institutions involved in providing healthservices, as well as data banks of physi-cians, international disease classifications,medicine and medical product codes haveall been identified and/or harmonised. Asystem for the surveillance of personnel,material and financial sources (The CoreSources Management System) has beencompleted. A Family Medicine Infor-mation System has been implemented tostore electronic patient record data in theprovinces where the new primary healthcare system has already been rolled out.Moreover, in October 2007 all publichospitals adopted the Medula System,which will enable the creation of a healthdatabase to be used for health care dataanalysis.7 This is an integrated informationsystem for the electronic collection ofbilling information from health careproviders and payments to health careservices by the Social Security Institution.*Efforts to determine further infrastructuralneeds related to the inclusion of all relevantactors in the health system are ongoing.

National pharmaceutical policy andefforts to establish evidence-basedpoliciesTurkey has been criticised not only for itslack of transparency in pricing and reim-bursement decisions, but also a lack ofcommunication with the pharmaceuticalindustry.8 The price of pharmaceuticalsused to be determined based on a cost-plusapproach until 2004. Concerns regardingthe rising share of pharmaceutical expen-ditures in total health care expendituresand pressure to contain public expenditurehave resulted in revisions of pricing policy.The MoH Decree on Pricing of MedicinalProducts for Human Use issued on 6February 2004 introduced externalreference pricing as the main price settingcriterion. The price of new drugs will beset to the lowest price in a basket ofreference countries (currently France,Italy, Greece, Spain and Portugal). Thereference price system has also improved

transparency: reference groups are formedbased on similar dosage, same active ingre-dient and same indication. Reimbursementlevels are set at the lowest price in areference group plus 22%.9

Pharmaceutical prices have been pusheddown due to a combination of discountseffectively applied to approximately onethousand products, a reduction in valueadded tax from 18% to 8% for pharma-ceuticals, and the increase in the negoti-ating power of the public insurancescheme as the sole buyer in the market.Turkey has had a unified reimbursementsystem since 2003 with a common positivelist for all social security funds. Reim-bursement is based on rules set out in theBudget Implementation Guidelines (BIG).The Reimbursement Commission, estab-lished in 2004, is the key body in thepreparation of BIG reimbursementdecisions and the inclusion of products onthe positive list. The inclusion/exclusioncriteria for the list are still not clear; budgetimpact has so far been the most influentialcriteria. A significant number of over thecounter (OTC) products were excludedfrom the list after 2004; however, there arestill a significant number of reimbursedOTC products which implies that,coupled with a better use of generics, theycan generate additional savings.8

Legislation enacted by the Social SecurityInstitution in 2007 stipulates thesubmission of an economic evaluation forall new pharmaceuticals requesting reim-bursement. The main challenge of thisdevelopment is the inadequacy of epidemi-ological and health care data in Turkey, aswell as a limited capacity in skills neededto build and evaluate pharmacroeconomicmodels. Health economics ‘know-how’ inTurkey needs to be developed both in theprivate and the public sector. A databasealso needs to be created to provide accessto information on the epidemiology ofdiseases, current treatment practices, theefficacy of treatment options and healthcare costs.10

Data exclusivity

New data exclusivity principles wereintroduced in 2005 as one of the steps onthe path to eventual membership of theEuropean Union. Data exclusivity appliesfor a period of six years following the firstregistration date within the EU CustomsUnion area and is valid provided that it islimited to the patent term. As part of EU

* The authority responsible for the social security provisions in Turkey.

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HEALTH POLICY DEVELOPMENTS

accession, this data exclusivity periodmight be extended to the 8+2+1 principlefor alignment with the EU.11

Tackling counterfeit drugs and a Track andTrace System

Counterfeit drugs have remained a prob-lematic issue in Turkey.7 A new DrugTrack and Trace System (ITS-Ilac TakipSistemi) has been implemented in Turkeyto reduce the amount of counterfeit drugsin circulation. Tracking of individual drugpackages has been mandatory sinceFebruary 2008. According to the newregulations a Datamatrix barcodeincluding information about the productcode, serial number, order number,production date and expiry date must nowbe printed on drug packages, in addition tothe already existing barcode require-ments.12

Future outlookThe Health Transformation Programmeand the EU accession process have beenthe major driving forces of health carereform since the beginning of the newmillennium. Efforts have been focused oncreating a purchaser-provider split,extending coverage to the whole popu-lation based on social insurance principlesand organising primary care throughfamily practitioners and autonomoushospitals.1 There have been considerablechanges in pricing and reimbursementpolicies to improve the objectivity andtransparency of decisions. Pharmaco-economic evaluations have been intro-duced as a new criterion in thereimbursement process. The need forsound information, robust data collectionand the development of human capacityfor health economic evaluation stand outas major hurdles to be overcome in thequest for sound evidence-based policymaking.

What are the next steps in the reformprocess? A number of key developmentscan be identified in the latest programmefor government published in September2007.13 These include the transformationof the Refik SaydamHygiene Centre (TheSchool of Public Health) which carries outresearch on health care systems, healtheconomics and health management intothe Turkish National Institute of Health.

An independent ‘National Pharmaceuticaland Medical Equipment Agency’ will alsobe established. This agency will developand audit the necessary guidelines for theproduction (including ingredients), import

and export of pharmaceutical products,cosmetics and medical devices. It will becharged with ensuring safety, effectiveness,quality and compliance with standards inproviding access to these products.

The family practitioner scheme will beextended to the whole country in cooper-ation with Ministry of Finance, SocialSecurity Institution, and local administra-tions. In this context, valuable experiencewith the current family practitioner prac-tices will be drawn upon to enact thenecessary legislation for the implemen-tation of a nationwide scheme.14 Thegovernmental health programme alsoaffirms a commitment to strengthen effortsto promote maternal and child health andbuild national programmes to combatnon-communicable diseases.

Finally, public hospital unions/associationswill be formed to increase the quality andefficiency of hospital services. Hospitalunions will be empowered through thedecentralisation of authority. Private sectorinvestments in health will be encouragedand all hospitals will be privatised grad-ually following pilot studies. HealthAccreditation Systems will also be devisedto increase the quality of care by settinginternational standards for health servicesand personnel.

REFERENCES

1. World Bank.Health Transition Project:Project Information Document. Wash-ington: Worldbank, 2003. Available at:http://www-wds.worldbank.org/external/default/WDSContentServer/WDSP/IB/2004/03/10/000104615_20040312101156/Rendered/PDF/Project0Inform1nt010Appraisal0Stage.pdf

2. Akdag R. The Progress so Far: TurkeyHealth Transformation Programme.Ankara: Ministry of Health, 2007.Available at http://www.hm.saglik.gov.tr/pdf/kitaplar/200709241502590.NeredeNereyeEn20070924.pdf

3. World Bank.Health Transition Project,Turkey, Integrated Safeguards Datasheet.Washington: Worldbank, 2004. Availableat: http://www-wds.worldbank.org/servlet/WDSContentServer/WDSP/IB/2004/04/23/000012009_20040423143124/Rendered/PDF/AC634.pdf

4. Adar S. Turkey: reform in social security.Journal of European Social Policy2007;17(2):167–68.

5. UNICEF. Say Yes, Winter 2007: Pre-venting Child Poverty in Turkey. Ankara:UNICEF, 2007. http://www.unicef.org/

turkey/sy19/cp39.html

6. Akdogan C.Hastaneye Giden Hastaları% 41Azalttı [Reduction of 41% in PatientReferrals to Hospitals]. Family Practi-tioners’ Portal, 4 December 2008. Availableat http://ailehekimleri.net/index.php?option=com_content&task=view&id=612&Itemid=2

7. Social Security Institution. Genel SağlıkSigortası. MEDULA [General HealthInsurance, MEDULA], July 2007.Available atwww.saglik.gov.tr/ESAGLIK/dosyagoster.aspx?DIL=1&BELGEANAH=22247&DOSYAISIM=MEDULA_GENELSami_Kiracli.pdf

8. Datamonitor. Emerging markets series:Benchmarking key countries Brazil, Russia,India, China and Turkey. London:Datamonitor, 2007.

9. Tatar M. Turkey Pharma Profile 2007.Vienna: Pharmaceutical Pricing andReimbursement Information Project, 2007.Available at http://ppri.oebig.at/Downloads/Results/Turkey_PPRI_2007.pdf

10. Buharali C. Turkiye’de ve Dunya’daSaglik Ekonomisi [Health Economics inTurkey and the World]. Istanbul: DeloitteTurkiye, 2008.

11. Sukkar E. Turkey’s reforms put pharmaon a better footing. SCRIP2007;3277:20–21.

12. SEDNA Distribution. DatamatrixUsage in Drug Tracking System. Istanbul:SEDNA Distribution, 2008. Available athttp://www.sedna.com.tr/content/view/61/1/lang,en

13. T.C. 60. Hukumet Eylem Plani, 10Ocak 2008. [Action Plan of the 60thGovernment of the Republic of Turkey, 10January 2008.] Available athttp://ekutup.dpt.gov.tr/plan/ep2008.pdf.

14. Senyurt D. Hükümetin Eylem Plani:Saglik sosyal güvenlik, Ar-Ge.MakroBakisSaglik Politikasi Gundemi. Available athttp://www.makrobakis.com/pdf/icerik/turkiye.pdf

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HEALTH POLICY DEVELOPMENTS

To Shakespeare’s Juliet, a rose by anyother name would smell as sweet.However, when it comes to prescriptiondrugs and Canadians, there is a lot in aname after all. Although generic drugsare widely used in hospitals, andprovincial drug programmes try topersuade people to take generic versionsof prescription drugs, research evidencesuggests some feel uneasy about makingthe switch.1,2 In addition to concernsgenerics are less safe and less effectivethan brand-name drugs,1,2 some patientsworry generics cause too many side-effects and are not favoured by theirphysicians.1

The problem is worsened by the fact fewhealth care professionals initiate conver-

sations with their patients about genericdrugs.1 In addition, factors such aspatient pressure, a lack of informationabout generic drugs, and loyalties to drugmanufacturers may make physiciansmore apt to prescribe brand-namedrugs,6,7 which may further instil doubtsabout generic medicines.

It all can leave Canadians wondering whyprovincial drug plans have adopted‘generics-first’ policies, where less costlybut equivalent generic drugs are substi-tuted for brand-name medicines.8 Inaddition, they may worry that qualityand safety are being compromised for thesake of the bottom line.

Different look, same qualityGeneric drugs have the same medicinalingredients as their brand-name counter-parts.9 The principal difference betweenthem is that only after the patents onbrand-name products have expired maygeneric companies produce theirproducts.10,11 Generic drugs are usuallyless expensive12–14 – costing on average45% less than the brand-names10 – butmay have a different shape or colour thanbrand-name counterparts.10 These drugsare often made by large, generic manufac-turers. Interestingly, a 2004 estimate finds27% of generic medicines – so called‘pseudogenerics’ – on the Canadianmarket are made by brand-namecompanies.15

Whoever makes them, all prescriptiondrugs in Canada undergo a review byHealth Canada, where drug ingredientsare checked and manufacturing processesand facilities are verified against the samefederal guidelines.8–10

Ingredients are the most importantelement in the review process. Medicinalor active ingredients must meet the sameHealth Canada standards whether thedrug is a generic or brand-name.9,10

Manufacturers are required to test eachdrug batch, both during and after

Mythbusters

Eurohealth Vol 14 No 433

Myth: Generic drugs are lower quality andless safe than brand name drugs

Mythbusters are prepared by Knowledge Transfer and Exchange staff at the CanadianHealth Services Research Foundation and published only after review by a researcherexpert on the topic.

The full series is available at www.chsrf.ca/mythbusters/index_e.php.This paper was first published in 2007. © CHSRF, 2007.

Comparison of prices of four brand-name and generic drugs approved for sale in Canadaa,b

Use (form)Brand-name(strength)

Brand-name price($) per single dosec

GenericGeneric price ($)per single dosec

Antibiotic (tablet) Zithromax (250 mg) 4.63 azithromycin 3.11

Cholesterol-lowering (tablet)

Zocor (80 mg) 2.24 simvastatin 1.39

Heartburn (tablet) Zantac (150 mg) 1.08 ranitidine 0.40

Ulcers (tablet) Losec (20 mg) 2.20 omeprazole 1.25

a. Each of the drugs in this table has been approved for sale in Canada.3

b. These drugs were selected from the 200 most frequently prescribed drugs in Canada in 2005 and2006.4

c. Although prices come from the Quebec formulary as of 18 April 2007,5 there is little price vari-ation across provinces. These prices are the wholesale prices and do not include pharmacist mark-ups or dispensing fees. Prices have also been rounded up to the nearest hundredth.

Eurohealth Vol 14 No 4 34

A series of essays by the Canadian HealthServices Research Foundation on the evidencebehind healthcare debates

production, to demonstrate they areequally safe and effective.8–10 In caseswhere the generic’s non-medicinal ingre-dients, which give it its colour and shape,are different from the brand-name’s,manufacturers must provide research toshow the drug meets the standard.9

Generic drug companies ultimately havetwo options to prove their products aresafe and effective. They may run theirown clinical drug trials, repeating most ofthe testing the brand-name manufacturershave carried out.9 Or they may showhow their drug compares with theoriginal brand-name drug in tests of‘bioequivalence.’9 Most generic drugcompanies opt for the latter option sincethe original brand-name drug has alreadybeen proven safe and effective.9 If eithertest proves successful, Health Canadawill give its approval, allowing thegeneric to be substituted for the brand-name

Smart substitutionDespite evidence some Canadians may bereluctant to embrace generic drugs,chances are most have taken thesemedications before. Generic drugsaccounted for 43% of all prescriptionsfilled for Canadians in 2005.16 Genericequivalents are not always available onthe market. And some literature indicatesthere are a minority of cases wherechanging the drug that is administeredmay be inappropriate, particularly fordrugs that are safe only when a precisedosage is administered.14

The example commonly cited in theresearch literature has shown patientswith epilepsy may be sensitive to changesin the brand of their anti-seizure medica-tions.14,17 However, it also appears thereare generics from this class that are safe tosubstitute.18 Moreover, there are thou-sands of generics on the market, all ofwhich appear to be well-tolerated bythose who can use them (knowingly orotherwise, as the case may be). Whilethere are always individual differences tohow people react to any drug, prescribinggeneric drugs, where appropriate, can beeffective and save money.

ConclusionGeneric drugs must pass the same level ofscrutiny from Health Canada as theirbrand-name counterparts. In the end,consumers and possibly some prescribersmay need to rethink some of theirassumptions about whether reserving aplace for brand-name drugs on theirmedicine shelf is always best.

REFERENCES

1. Gaither CA, Kirking DM, Ascione F,Welage LS. Consumers’ views on genericmedications. Journal of the American Phar-maceutical Association 2001;41(5):729–36.

2. Pereira JA, Holbrook AM, Dolovich Let al. Are brand-name and generic warfarininterchangeable? A survey of Ontariopatients and physicians. Canadian Journalof Clinical Pharmacology2005;12(3):e229–e239.

3. Health Canada. Drug Product Database.Ottawa: Health Canada, 2007. Available atwww.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index_e.html

4. Cavallucci S. The top 200: What’smaking waves in prescription sales.Pharmacy practice 2006;22(12). Available athttp://www.pharmacygateway.ca/pdfs/2006/12/ppractice_top200_dec06.pdf

5. Regie de l’assurance maladie. List ofMedications. Quebec: Regie de l’assurancemaladie, 2007. Available athttp://www.ramq.gouv.qc.ca/en/regie/lois/liste_med.shtml

6. Mott DA, Cline RR. Exploring genericdrug use behaviour: the role of prescribersand pharmacists in the opportunity forgeneric drug use and generic substitution.Medical Care 2002;40(8):662–74.

7. Kirking DM, Gaither CA, Ascione F,Welage LS. Physicians’ individual andorganizational views on generic medica-tions. Journal of the American Pharma-ceutical Association 2001;41(5):718–22.

8. Health Canada, Health Products andFood Branch. Access to TherapeuticProducts: The Regulatory Process inCanada. Ottawa: Health Canada, 2006.Available at www.hc-sc.gc.ca/ahc-asc/alt_formats/hpfb-dgpsa/pdf/pubs/access-therapeutic_acces-therapeutique_e.pdf

9. Health Canada. The Safety and

Effectiveness of Generic Drugs. Ottawa:Health Canada, 2006. Available atwww.hc-sc.gc.ca/iyh-vsv/alt_formats/cmcd-dcmc/pdf/ genericdrug_e.pdf

10. Canadian Pharmacists Association.Drugs: FromResearch Lab to PharmacyShelf. Ottawa: CPA, 2007. Available atwww.pharmacists.ca/content/hcp/resource_centre/drug_therapeutic_info/pdf/DrugApprovalProcess.pdf

11. Government of Canada, Department ofJustice. (Act current to February 28, 2007).Patent Act (R.S., 1985, c. P-4 ). Available athttp://laws.justice.gc.ca/en/ShowFullDoc/cs/P-4///en

12. Morgan S, Kozyrskyi A, Metge C,Roos N, Dahl M. Pharmaceuticals:Therapeutic Interchange and PricingPolicies.Winnipeg: Manitoba Centre forHealth Policy, 2003. Available athttp://mchp-appserv.cpe. umanitoba.ca/reference/generic.pdf

13. Haas JS, Phillips KA, GerstenbergerMS, Seger A. Potential savings fromsubstituting generic drugs for brand-namedrugs: Medical expenditure panel survey,1997–2000. Annals of Internal Medicine2005;142(11):891–97.

14. Sprague D. Generics make sense forpatients and prescribers. Practice Nurse2005;29(1):30–32.

15. Grootendorst P. Effects of “Authorized-Generics” on Canadian Drug Prices. Paperpresented at the Competition Bureau Intel-lectual Property Symposium, Ottawa, 2007.

16. IMS Health. Prescription DrugPurchases by Canadian Hospitals andPharmacies Reach $16.57 billion in 2005.Montreal: IMS, 2006. Available atwww.imshealth.com/web/content/0,3148,77303623_63872702_77770096_77808854,00.html

17. Andermann F, Duh MS, Gosselin A,Paradis PE. Compulsory generic switchingof antiepileptic drugs: high switchbackrates to branded compounds comparedwith other drugs. Epilepsia2007;48(3):464–69.

18. Ontario Ministry of Health andLong-Term Care. Drugs Funded byOntario Drug Benefit (ODB) Program:Edition 39. Ottawa: Ministry of Healthand Long Term Care, 2007. Available athttp://www.health.gov.on.ca/english/providers/program/drugs/edition_39.html

A large US survey has reported on coffee, tea, andvarious forms of alcohol.1,2 The results will warm thecockles of some hearts.

StudiesA representative sample of the US population wasselected and studied between 1988 and 1994. Subjectswere interviewed at home, and attended an examination,with blood and urine sample collection. During the inter-views, a food frequency questionnaire was used whichascertained the frequency of consumption of coffee, tea,and alcoholic beverages, as well as soft drinks that mightcontain caffeine. Serum uric acid was also measured.

ResultsThe survey used data from over 14,000 people aged overtwenty years of age. Those with gout, or taking allop-urinol or uricosuric agents were excluded.

Coffee, tea, and caffeineUsing a quintile of consumption approach, uric acidlevels were identical across quintiles of intake of totalcaffeine and tea. For coffee (including decaffeinated),drinking more than four cups of coffee a day significantlylowered serum uric acid levels, by about 8% at maximum(Figure 1). The reduction of uric acid by coffee remainedafter adjusting for a whole range of variables and dietaryfactors.

AlcoholUsing the quintile of consumption approach drinkingwine did not affect serum uric acid levels at any level ofconsumption up to one serving per day or more. Theconsumption of spirits, and especially beer, did increaseserum uric acid levels (Figure 2), even after adjusting for awhole range of factors. Beer and spirits drunk dailyincreased serum uric acid by about 10%; wine did not.The results were similar in men and women, and at lowerand higher levels of body mass index.

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Gout and drinking

People with gout, and their carers, tend to the obsessive when it comes to food, andespecially drinking; alcohol and coffee are often banned completely. All of whichmakes for a bland existence, which is why a frequently asked question is what goutsufferers can drink without exacerbating their condition.

Evidence-basedhealth care

Bandolier is an online journal about evidence-based healthcare, written by Oxford scientists.Articles can be accessed at www.jr2.ox.ac.uk/bandolier

This paper was first published in 2007. © Bandolier, 2007.

-5

0

5

10

15

20

25

0 0.01–0.09 0.1–0.49 0.5–0.99 ≥1.0

Frequency (servings per day)

Difference in serum uric acidfrom no comsumption (µmol/L)

Beer Spirit Wine

280

290

300

310

320

0 <1 1–3 4–5 ≥6

Cups of coffee per day

Serum uric acid (µmol/L)

Figure 1: Reduction in mean serum uric acid levels according to quintiles of dailyintake of coffee

Figure 2: Effect of different daily consumption (quintiles) of different alcoholicbeverages on mean serum uric acid levels

Eurohealth Vol 14 No 4 36

EVIDENCE-INFORMED DECISIONMAKING

CommentThis constitutes useful additionalknowledge about what gout suffers mightdo to avoid increasing their serum uricacid, and perhaps precipitating an attack,or making the pain worse. Drinking beerand spirits are out, but tea and wine haveno effect, while coffee actually seems toreduce uric acid levels. We have had somestraws in the wind about coffee before,but this adds weight.

More weight comes from a large study ofcoffee consumption and incident gout inmen,3 following 46,000 men with nohistory of gout at baseline for twelveyears. There were 750 cases of incident

gout, and the risk was lower with highercoffee consumption, before and afteradjustment for a whole host of differentpossible confounding factors (Figure 3).So increased coffee drinking is linkedwith both reduced serum uric acid levelsand reduced incidence of clinical gout.

We also have information about what weeat and the risk of incident gout.4 Thishas been examined in detail on theBandolier Internet site, but the mainresults are worth reiterating. Increasedconsumption of meat was associated withincreased risk of gout, but only with beef,pork, and lamb. There was less associ-ation with seafood, and none with purine

rich vegetables. Increased consumptionof dairy food reduced the risk of gout.We find the same now for uric acid5

where high meat and to a small extentseafood consumption is associated withhigher uric acid levels, but dairy foodwith lower uric acid levels. Much foodfor thought for those with gout and forhealthy eating.

REFERENCES

1. Choi HK, Curhan G. Coffee, tea, andcaffeine consumption and serum uric acidlevel: third National Health and NutritionExamination Survey. Arthritis &Rheumatism 2007;57:816–21.

2. Choi HK, Curhan G. Beer, liquor, andwine consumption and serum uric acidlevel: third National Health and NutritionExamination Survey. Arthritis &Rheumatism 2004;51:1023–29.

3. Choi HK, Willett W, Curhan G. Coffeeconsumption and risk of incident gout inmen. Arthritis & Rheumatism2007;56:2049–55.

4. Choi HK, Atkinson K, Karlson EW,Willett W, Curhan G. Purine-rich foods,dairy and protein intake, and the risk ofgout in men. New England Journal ofMedicine 2004;350:1093–103.

5. Choi HK, Liu S, Curhan G. Intake ofpurine-rich foods, protein, and dairyproducts and relationship to serum levelsof uric acid. Arthritis & Rheumatism2005;52:283–89.

0

0.2

0.4

0.6

0.8

1.0

0 <1 <1 1–3 4–5 ≥6

Cops of coffee per day

Relative risk of incidence of gout

Figure 3: Relative risk of incident gout in 12-year follow up of 46,000 men, according to quintilesof daily coffee consumption

Pre-announcement: Observatory Venice Summer School 2009

‘Innovation and Health Technology Assessment: Improving Health System Quality’

The European Observatory onHealth Systems and Policies andthe Region of Veneto announcethe next annual ObservatoryVenice Summer School which willtake place on the island of SanServolo, 26–31 July 2009

The target audience is senior tomid-level policy-makers and morejunior professionals who aremaking careers in policy andmanagement at a regional,national or European level. Allparticipants should be working ininstitutions with decision-makingpowers, relevant provider or payerassociations or public HTAagencies or professional bodies.Applications are welcome from allcountries in the European Region.

The Summer School is accreditedby the European AccreditationCouncil for Continuing MedicalEducation.

Topic: The 2009 school will look at the role of innovation and Health Technology Assessment (HTA) as tools forimproving quality and outcomes of health care. The course will have an emphasis on HTA, its implications and theassociated demands as regards information, including identifying when innovation or new research is needed. Itwill bridge the gaps between generalist system planning; specialist HTA expertise; and the impact on practitionersof HTA led developments.

Objectives: The aim is to raise key issues; share participants’ insights (whether they are practitioners or analysts),and build networks. Specifically, the Summer School aims to develop a greater understanding of (1) the challengesof innovation in health technologies and health care delivery – and how to ensure that services are safe, effective,appropriate and cost-effective, (2) how evidence and context interact and (3) how evidence impacts on clinicalpractice and on policy processes.

Outline: This 5-day course consists of lectures, short presentations from participants, discussions and group work.The approach will be participative, but there will be a core of formal teaching (in English). It will address systemsfor developing and assessing health care products (drugs, diagnostics and devices) as well as clinical and policyinterventions, such as regulatory approval, reimbursement systems and national guidance. It will also look at howevidence is used and how HTA and innovation contribute to quality improvement programmes and strategies.

Faculty: The course will be led by Professor Reinhard Busse, the Observatory and Berlin University of Technology,and John-Arne Røttingen of the Norwegian Knowledge Centre for Health Services and the Observatory, withinternational experts and practitioners serving as lecturers and facilitators.

Organization: Applications with CVs will be invited in a formal announcement shortly. A selection process willfollow and a limited number of bursaries will be available.

For more details, visit www.observatorysummerschool.org or email summerschool2009@obs.euro.who.int

Eurohealth Vol 14 No 437

NEW PUBLICATIONSEurohealth aims to provide information on new publications that may be ofinterest to readers. Contact Sherry Merkur at s.m.merkur@lse.ac.uk if you wishto submit a publication for potential inclusion in a future issue.

Good practices in health financing: lessons fromreforms in low- and middle-income countries

Edited by: P Gottret, GJ Schieber andHRWaters

Washington: The International Bank forReconstruction and Development / The WorldBank, 2008

ISBN-13: 978 0 8213 7511 2

504 pages

Freely available online at:http://siteresources.worldbank.org/INTHSD/Resources/376278-1202320704235/GoodPracticesHealthFinancing.pdf

This book systematically assesses healthfinancing reforms in nine low andmiddle-income countries that havedemonstrated “good performance” inexpanding their populations’ healthinsurance coverage – to both improvehealth status and protect against cata-strophic medical expenses. Goodperformance also includes average orbetter-than-average population healthoutcomes relative to resources devotedto health, national income and educa-tional levels.

Among the countries that are in theprocess of achieving high levels ofpopulation coverage and financialprotection, nine were selected asexamples of good performance by anexpert steering committee, theseinclude: Chile, Colombia, Costa Rica,Estonia, the Kyrgyz Republic, SriLanka, Thailand, Tunisia and Vietnam.Each country case is analysed using astandardised taxonomy that capturesthe key health and non health sector-specific factors affecting the

performance of its health financing.

The study seeks to identify commonenabling factors of their goodperformance. While the findings foreach country are important, the volumesends a clear message to the globalcommunity that more attention isneeded to define “good practice” andthen to evaluate and disseminate theglobal evidence base.

Contents: Foreword; Acknowledg-ments; Executive summary; Acronymsand abbreviations;

Part 1 – Assessing good practice inhealth financing reform:1. Introduction;2.Health financing functions;3. Criteria for defining ‘good practice’and choosing country cases;

4. Summaries of country cases;5. Enabling factors for expandingcoverage;

Part 2 – Nine case studies of goodpractice in health financing reform;Appendix A; Index.

Health technology assessment and healthpolicy-making in Europe. Current status,challenges and potential

Edited by: MV Garrido, FB Kristensen,CP Nielsen and R Busse

Copenhagen: World Health Organization onbehalf of the European Observatory on HealthSystems and Policies, 2008

ISBN: 978 92 890 4293 2

181 pages

Freely available online at:http://www.euro.who.int/Document/E91922.pdf

Health technology assessment (HTA)aims to inform health policy anddecision-making processes concerninghealth technologies on organisational,societal and ethical issues. HTA has astrong foundation in research on thehealth effects and broader implicationsof the use of technology in health care.Its potential for contributing to saferand more effective health care is widelyacknowledged in Europe and interest inthis field has been growing steadily.

Since the establishment of the firstnational HTA agency in Sweden in the1980s, the number of institutionsinvolved in the assessment of healthtechnologies has multiplied in Europe.Most European Union Member Stateshave established a formal HTAprogramme or are considering the feasi-bility of establishing HTA intelligenceto inform health policy-making. Sinceits inception, the HTA community hasacknowledged the need for interna-tional collaboration and networking.

As a result of these developments, thisbook has been produced as a collabo-

ration between the EUnetHTA Projectand the European Observatory onHealth Systems and Policies with theaim of reviewing the relationshipbetween HTA and policy-making fromdifferent perspectives, with a specialfocus on Europe. The aim is to transmitthe value of HTA more broadly todecision makers and health caremanagers in order to increase theirawareness of HTA activities andevidence-based decision making.

Contents:Introduction;

1. Transnational collaboration on HTA– a political priority in Europe;

2. Policy processes and HTA;3.What is HTA?4.Health systems, health policy andHTA;

5.HTA in Europe – an overview of theproducers;

6.What are the effects of HTA reportson the health system? Evidence fromthe research literature;

7. Needs and demands of policy-makers;8. Future challenges for HTA in Europe.

Eurohealth Vol 14 No 4 38

Please contact Philipa Mladovsky atp.mladovsky@lse.ac.uk to suggest web sites

for potential inclusion in future issues.

eHealth ERA

http://www.ehealth-era.org

Gapminder

http://www.gapminder.org

Czech EU Presidency 2009

http://www.eu2009.cz/en/

Gapminder is a non-profit venture aiming to promote sustainable global development throughincreased use and understanding of statistics at local, national and global levels. The English-language web site makes time series data freely available in the form of ready-made videos, Flashpresentations and PDF charts showing major global development trends with animated statisticsand colourful graphics. In addition to various economic, demographic, social and environmentalindicators, various basic mortality and morbidity indicators are available. Data is available both atthe country level and additionally at the sub-national level for China, India and the USA.

European Society for Qualityin Healthcare (ESQH)

http://www.esqh.net

The Limerick-based ESQH is a not-for-profit organisation dedicated to the improvement of qualityin European health care. It consists of nineteen member national societies. The English languageweb site provides news, contact information for the national members, details and documentationfrom various workgroups, information about European funded projects and conferences, includingdownloadable presentations and links to related web sites.

NHS Confederation

http://www.nhsconfed.org

The NHS Confederation is an independent membership body of NHS organisations across theUK. The web site hosts theHealth Services Research (HSR) Network, a network of over onehundred organisations, including sixty groups of health services researchers in universities, otherinstitutes and forty NHS bodies, and also the SDO Network, a network of NHS Trusts. Theweb site provides emailed daily press summaries and a weekly Interchange Alert. It also containsbriefing and consultation papers, reports and detailed discussion documents. Policy networksgive electronic updates on specific policy issues. There are also details of the Confederation’sannual conference, exhibition and one-day conferences , as well as meetings on specific policyareas.

News and information from the Czech presidency of the European Union

The objective of the eHealth ERA project is to contribute to the coordination of Member States’eHealth strategy formulation and implementation, as well as eHealth-related research and tech-nological development, by establishing an European Research Area (ERA) in the subject. TheEnglish language web site provides a database containing documents on national eHealth priorities,strategies, roadmaps, programmes, as well as the contact details of experts for EU and other coun-tries. The site also contains news on eHealth related events, downloadable publications, a newsletterand links to other relevant organisations.

European Union of MedicalSpecialists (UEMS)

http://www.uems.net

The UEMS represents national associations of medical specialists in thirty-five EU and associatedcountries. The English and French language web site provides links to the national associations, aswell as details of meetings, UEMS charters and declarations, annual reports, position papers and anewsletter. Documentation of working groups covering the following topics is made available:eHealth, postgraduate training, quality in patient care and specialist practice in current healthsystems. In addition, the site hosts the web pages of the European Accreditation Council forContinuing Medical Education and makes available reports from all member countries on thestructure and development of Continuing Medical Education and Professional Development(CME-CPD).

WEBwatch

Eurohealth Vol 14 No 4 39

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PRIORITIES OF THE CZECHRESIDENCY

The overarching priorities of theCzech Presidency are the three‘E’s’: Economy, Energy andEurope in the world. Unsurpris-ingly, much attention is focusedon ways of addressing the globalcredit crunch and strengtheningenergy security through furtherdiversification of energy suppliesfrom external sources.

Priorities for healthFinancial Sustainability

One key area to be addressedwithin the health programmeconcerns the implications of theglobal economic credit crunch.Already questions are beginningto be asked about the financialsustainability of different healthcare systems. The Presidency willfocus primarily on the definitionof financial sustainability and itsobjectives, and on the analysis ofthe resources available for healthcare funding. In terms of long-term care funding, attention willbe drawn to the pressure it facesas a result of the growing demandfor services, in relation both tonegative demographic trends andthe lack of providers of this typeof care. A May 2009 high-levelconference is to provide a forumfor Member States to share expe-rience and exchange informationand best practice concerninghealth care systems and theirfinancial sustainability.

Patient safety

The main objective of theinitiative addressing patientsafety and health care quality isto provide support to MemberStates in their efforts to ensuresafety and quality standards,namely the continuous qualityimprovement (CQI) of healthcare and patient safety withinnational and regional systems.The Presidency will also partic-ipate in the adoption of appro-priate measures for infectioncontrol and the definition ofrelevant standards and preventivemeasures. The prevention andcontrol of antimicrobial resist-

ance and health care-associatedinfections, with an emphasis onEuropean hospitals, will be apriority. An April 2009 minis-terial conference is expected toprovide recommendations forspecific measures concerningantibiotic programmes inEuropean hospitals and suitablemodels for the support andfinancing of these programmesby national governments andhealth care payers, especiallyhealth insurance companies.

Pharmaceuticals and otherpriorities

The pharmaceutical packagecontains proposals on three keyissues: to improve the func-tioning of the pharmacovigilancesystem at European level, tostrengthen the legal distributionchain for pharmaceuticals againstillegal or counterfeit productsand to provide the general publicwith information on prescriptionpharmaceuticals (see articlebelow).

Other elements in the healthprogramme include further workto set out an overall frameworkfor the provision of cross-borderhealth care. The Presidency willalso seek to address the growingmobility of health care workers.In respect of the quality andsafety of organ donation andtransplantation, a new legislativeinitiative will include principlesproviding a general frameworkfor quality and safety in relationto the medical use of humanorgans; the creation of a commonset of quality and safety stan-dards for organ transport andstorage; and reporting seriousadverse events.

The Presidency is also lookinginto the issue of improving coop-eration between Member States,increasing the quality of healthcare provision with the help oftelemedicine, and strengtheningthe interoperability of infor-mation systems in the health caresector. In February 2009, thetopic of e-Health will bediscussed at a ministerialconference.

Health in all policiesHealth issues are also coveredthrough a number of actions andinitiatives to be found in differentpolicy areas.

Road safety

One health-related theme withintransport policy is road safety.The high number of people killedon European roads requires anenhancement of Europe-wideefforts to improve road safety.One objective is to begindiscussion on the future orien-tation of EU policies concerningroad safety. The outcome shouldbe the adoption of a newEuropean Road Safety ActionProgramme for 2011–2020 in thesecond half of 2009 or in the firsthalf of 2010.

e-Accessibility

Within telecommunications thePresidency will focus on over-coming barriers via informationand communication technologies.This includes work on inclusioninto the information society (e-Inclusion), including the issue ofthe accessibility of informationand communication technologiesto older people and those withdisabilities (e-Accessibility).

Health and the environment

Health is a major aspect of theenvironmental programme. Itfocuses on a number of specificissues including: progress in theproposal for a directive on indus-trial emissions; finalising thediscussions on the review of theproposal for the regulation onozone-depleting substances;initiating discussions on aproposed review of the directiveon national emission ceilings forcertain atmospheric pollutants, ifsubmitted by the Commission;and discussions on proposals fordirectives reviewing themanagement of waste electricaland electronic equipment.

The Presidency will also discussthe management of biowaste, inconnection with the EuropeanCommission’s published GreenPaper. It will also coordinate anumber of international meetingsand activities on the protection of

New

s

Press releases andother suggestedinformation forfuture inclusioncan be e-mailed tothe editorDavid McDaidd.mcdaid@lse.ac.uk

the environment and health, for example,negotiations on long-term internationallegally-binding measures to reduce risksfrom releases of mercury to preventfurther environmental contamination at aglobal level. These negotiations will takeplace during the 25th session of theGoverning Council of the UnitedNationsEnvironment Programme, in February2009 in Nairobi.

Active inclusion

Within the field of employment and socialpolicy, the programme will focus onservices as a tool for preventing socialexclusion and for active inclusion ofvulnerable groups. The Presidency willorganise a conference to discuss socialinclusion issues and will propose theadoption of the Council conclusions.Attention will also be paid to theimprovement of quality, the availabilityand financing of long-term care,protection of the dignity and rights ofpeople dependent on care, and support foran active, healthy ageing and ageing well.

More information on Presidency prior-ities at http://www.eu2009.cz/en/czech-presidency/programme-and-priorities/programme-and-priorities-479/

EUROPEAN MONITOR

Europe needs to intensify and doublecancer screeningCancer is the second most common causeof death in the EU. Breast, cervical andcolorectal cancer accounts for 32% ofcancer deaths in women and 11% in men.With an ageing population, the figures aredue to increase unless preventivemeasures are taken. The EU shares acommon commitment to ensuring properscreening for breast, cervical andcolorectal cancer, as set out in CouncilRecommendation of 2 December 2003 oncancer screening (2003/878/EC). In thefirst implementation report, theCommission highlights that, althoughmuch progress has been made in the fieldof cancer screening, Member States havenot fully put screening in place.

Findings

The report notes that while the currentannual volume of screening examinationsin the EU is considerable, this is less thanhalf the minimum number that would beexpected if the tests specified in theCouncil Recommendation on cancerscreening were available to all EU citizens

of appropriate age (approximately 125million examinations per year). Less thanhalf of these examinations (41%) areperformed in population-basedprogrammes which provide the organisa-tional framework for implementingcomprehensive quality assurance asrequired by the Council Recommen-dation. Only twenty-two Member Statesare running or establishing population-based screening programmes. For cervicaland colorectal cancer screeningprogrammes this falls to fifteen andtwelve Member States respectively.

The way ahead

By providing a clear description of thesituation and the gaps, the report helps torenew the commitment to put in placebreast, cervical and colorectal cancerscreening as a crucial and cost-effectivemeasure to reduce the burden of cancer inthe EU.

The report indicates that Member Statesneed to continue to improve orimplement population-based cancerscreening programmes. Additional effortsshould be made to improve and maintainscreening measures to assure the quality,effectiveness and cost-effectiveness on aMember State as well as EU level.

At an EU level, the Commission intendsto form a European partnership for actionagainst cancer in 2009 by bringingtogether relevant stakeholders across theEU. Key areas for future cancer activitieswill include: health information,collection and analysis of comparabledata; primary prevention; identificationand promotion of good practice in cancer-related health care; priorities for cancerresearch.

The European Commissioner for Health,Androulla Vassiliou, said that “in thesetimes of financial uncertainty, we need torecognise, more than ever, the importanceof planning for a healthy future. Investingin cancer screening programmes will paylong term dividends, as prevention is themost efficient and cost-effective way tominimise the European burden of cancer.”

The Report on the Implementation of theCouncil Recommendation of 2 December2003 on cancer screening is available athttp://ec.europa.eu/health/ph_determi-nants/genetics/keydo_genetics_en.htm

The Council Recommendation of 2December 2003 on cancer screening isavailable at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:

2003:327:0034:0038:EN:PDF

Commission takes steps to promotepatient safety in EuropeEach year in the EU between 8% and12% of patients admitted to hospitalssuffer harm from the health care theyreceive, including from health care asso-ciated infections (HCAI). Much of thatharm is preventable. On 15 December, theCommission adopted a Communicationand proposal for a Council Recommen-dation with specific actions that MemberStates can take, either individually, collec-tively or with the Commission, toimprove the safety of patients.

The Communication follows a recentpublic consultation on patient safety andan earlier consultation on the specificthreat to safety posed byHCAI.Workinggroups representing Member States andkey stakeholder groups, including healthprofessionals and patients, contributed todiscussions on both the issue of generalpatient safety aspects and health care asso-ciated infections in particular.

Speaking of the Communication,Commissioner for Health, AndroullaVassiliou, stated that “patient safety is thecornerstone of good quality health care. Iwould like to see a Europe for patientswhere safety is paramount and citizens areconfident and knowledgeable about thecare they receive.”

According to the European Centre forDisease Prevention and Control (ECDC),each year 4.1 million patients in the EUhave a hospital acquired infection, equiv-alent to one in twenty hospitalisedpatients. The additional costs to Europeanhealth systems have been estimatedconservatively to be €5.48 billion per year.

Well-known examples of such infectionsinclude those caused by the bacteriumMRSA (meticillin-resistant Staphylo-coccus aureus). However, recent studieshave shown that HCAI can be reduced byup to a third when certain infectionprevention and control measures andstructures are put in place.

The most common types of adverseevents in health care are: HCAI; incorrector delayed diagnoses; surgical errors; andmedication related errors. Most efforts toimprove patient safety at Member Stateand EU levels have so far focussed onspecific causes, for example, minimisingthe risk frommedicinal products, medicaldevices or antimicrobial resistance.However, most adverse events are caused

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by a combination of factors whichtogether result in harm to patients.

The Commission Communication thusrecommends a comprehensive approachto improving patient safety. The primaryfocus is on addressing systemic andorganisational failures responsible formost harm to patients. In respect of infec-tions, key recommendations for MemberStates include: putting in place specificmeasures to prevent and control infec-tions; ensuring that infection preventionand control is enhanced in hospitals; andhaving effective systems in place to detectand report infections. Other patient safetyrecommendations include: establishing orstrengthening reporting and learningsystems; embedding patient safety in theeducation and training of health careworkers; involving patients in the devel-opment of safety measures; and providingpatients with relevant information onhealth risks and safety issues. MemberStates are also encouraged to share bestpractice and expertise in this field. TheCommission will work with MemberStates to develop common definitions andindicators for patient safety.

More information at http://ec.europa.eu/health/ph_systems/patient_safety_en.htm

Antitrust: preliminary report onpharmaceutical sector inquiryOn 28 November the EuropeanCommission published its preliminaryreport on the competition inquiry into thepharmaceutical sector. A sector inquiry isan information gathering exercise thatprovides the Commission with in-depthknowledge about markets, with a view tobetter identifying obstacles to compe-tition. Essentially, the Commission opensa sector inquiry when it has concerns thatcompetition may not be working as itshould, but the reason for this is not clear.This inquiry began in January 2008 toexamine why fewer new medicines werebrought to market and why generic entryseemed to be delayed in some cases.

Publication of the controversial reportfollowed two separate raids on the officesof major pharmaceutical firms last year.The manner of the investigation wasstrongly criticised by industry represen-tatives, but the Commission justified itsactions by saying it believed somecompanies may be engaged in “restrictivebusiness practices and/or the abuse of adominant market position”.

The preliminary report concludes that

competition in this industry does notwork as well as it should. It states thatoriginator companies (that develop andsell new medicines) used a variety ofmethods to maintain high income streamsby delaying or blocking market entry ofgeneric companies and other originatorcompanies.

Practices vis-à-vis generic companiesinclude multiple patent applications (inone case 1,300) for the same medicine (so-called patent clusters), as well as the initi-ation of disputes and litigation, withnearly 700 cases of reported patent liti-gation with generic companies, on averagelasting almost three years. Originatorcompanies also concluded more than 200settlement agreements with genericcompanies in the EU, in which theyagreed on the terms for ending an ongoinglitigation or dispute. More than 10% ofthe settlements were so-called ‘reversepayment settlements’ which limited theentry to the market of the generic medi-cines and provided for payments from theoriginator to the generic companies.These payments amounted in total tomore than €200 million. Originatorcompanies also intervened in nationalprocedures for the approval of genericmedicines in a significant number of cases,which on average led to four months ofdelay for the generic medicine.

Where successful, these practices result insignificant additional costs for publichealth budgets – and ultimately taxpayersand patients – and reduce incentives toinnovate. Based on a sample of medicinesthat faced generic entry in the period2000–2007, average price levels for medi-cines decrease by almost 20% after thefirst year following generic entry. In rarecases, the decrease in price levels can be ashigh as 90%. For the sample underanalysis, total savings gained by genericentry amounted to at least€14 billion overthe period. Without these savings, totalexpenditure for the medicines analysedwould have been over 25% higher.

The inquiry confirmed that generic entryoften occurs later than expected. Onaverage it took about seven months forgeneric products to enter the market on aweighted average basis and even the top-selling medicines faced an average delayof four months. Given the strong impactof generic entry, this amounted to lostsavings of about €3 billion to healthsystems during 2000–2007 for the chosensample of medicines facing patent expiryin seventeen Member States. In relative

terms it could have reduced the bill forthese medicines by over 5%. The prelim-inary findings suggest that the practicesunder investigation contributed to theseshortcomings.

Stakeholders also made a significantnumber of comments on the regulatoryframework. In particular, both generic andoriginator companies called for a singleCommunity Patent and the creation of aunified and specialised patent judiciary inEurope. These calls are also supported bythe preliminary findings of the inquiry. Itdiscovered 11% of contradictory finaljudgments in litigation cases and totaldirect costs associated with the patent liti-gation of €420 million. Such contradic-tions and the costs related to the litigationcould be avoided, or as a strict minimumreduced, with a Community Patent and anunified specialised patent judiciary.

Competition Commissioner Neelie Kroessaid that “competition in the pharmaceu-ticals market is vital for people to getaffordable and innovative medicines, andto make sure that taxpayers get the bestvalue for money out of their health caresystem. These preliminary results showthat market entry of generic companiesand the development of new and moreaffordable medicines is sometimesblocked or delayed, at significant cost tohealth care systems, consumers andtaxpayers. We now have a solid view ofwhat is happening and why: the next stepis to discuss our findings with the stake-holders and to draw the necessary conclu-sions. It is still early days, but theCommission will not hesitate to openantitrust cases against companies wherethere are indications that the antitrustrules may have been breached.”

Following the publication of the prelim-inary report, a public consultation ranuntil 31 January 2009. More than fortysubmissions to the consultation processwere received. These will be posted onlinewithin weeks, the EU executive has nowconfirmed. A final report is due later inthe year.

The preliminary report and moreinformation on the inquiry are availableat http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html

New pharmaceutical legislationunveiledOn 10 December the EuropeanCommission unveiled new pharmaceu-

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tical legislation designed to improvemedicinal information available topatients and combat the growing prolifer-ation of counterfeit medicines in the EU.Commission Vice-President GünterVerheugen said the priority of the‘pharma package’ was patients’ health andsafety, although he stressed that having a“healthy European pharmaceuticalsector” was very important too.Verheugen expressed his hope that thepackage would help Europe to achieve itsgoal of being “the chemist of the world”and the global “standard bearer for highquality bio-tech work”.

A key aspect of the package proposesstricter rules on the availability of infor-mation about prescription-only medi-cines. The Commission wants to givepatients access to centralised EU infor-mation on their side effects. Moreover, toensure clarity of information, the EUexecutive calls for advertising ofprescription medicines to be scrapped. Italso wants to introduce stricter rulesregarding the content of pharmaceuticaladverts, including those on the internet, inthe form of an EU code of conduct.

A further important element of thepackage concerns the fight against coun-terfeit medicines, imports of which haverisen steadily for the past three years.Some 2.5 million packages of counterfeitmedicine were seized at EU borders in2007. To tackle the growing problem,Commissioner Verheugen said thepackage outlined “various steps to makesure the supply chain is secure”.

The Commission is proposing tointroduce three safety features to ensurethe ‘total traceability’ of all medicinesbought in pharmacies or online. These area (still to be finalised) standardisedbarcode, an authenticity feature guaran-teeing that a medicine’s contents are whatthey should be and a standard seal toprovide protection from tampering.

The proposed legislation has met with amixed response. Monique Goyens,Director General of The EuropeanConsumers’ Organisation (BEUC),dismissed the guidelines as being just “adisguised way of giving pharmaceuticalcompanies greater flexibility to providethe information they want on prescriptionmedicines directly to the public, namelydirect-to-consumer communicationstrategies – the goal of which in our viewis to boost sales.” The European GenericsMedicine Association EGA) also raised

concerns over the “possible misuse ofinformation as a marketing tool,” addingthat it is “crucial that the proposal ensuresbetter – rather than simply more - infor-mation to patients in order to avoid anyform of direct marketing and exertingundue commercial influence overconsumers.”

In contrast, Arthur J Higgins, Chief Exec-utive Officer of Bayer HealthCare andpresident of the European Federation ofPharmaceutical Industries and Associa-tions (EFPIA), welcomed the publicationof the pharma package saying that we“recognise the benefit to EU citizens andpatients of the new provisions for phar-macovigilance and improved access tohealth and medicines information.”However industry stakeholders claimedthat the EU executive failed to adequatelyaddress the problem of counterfeit drugssold on the internet. The EuropeanGeneric Medicines Association (EGA)also said “solutions should focus onwhere the problems are. The EGAtherefore is concerned that the mainsource of counterfeiting, the internet, isnot addressed by the package”.

The Commission’s proposals will now besubmitted to the European Parliamentand European Council, where they willbe discussed and voted upon under theco-decision procedure. The measurescould become law within eighteenmonths.

More information on the proposedlegislation available athttp://ec.europa.eu/enterprise/pharma-ceuticals/pharmacos/pharmpack_en.htm

European Court of Auditors criticises ECdevelopment health financingThe European Court of Auditors haspublished a report looking at theEuropean Commission’s (EC) financingfor health in sub-Saharan Africa. Thereport was a response to a 2007 mid-termreview by the United Nations of progresson all theMillenniumDevelopment Goals(MDGs). This report, while acknowl-edging the failure to meet MDG goalsacross the world, observed that leastprogress had been made in Sub-SaharanAfrica.

The objective of the audit was to assesshow effective EC assistance has been incontributing to improving health servicesin sub-Saharan Africa in the context of theEC’s commitments to poverty reductionand the Millennium Development Goals

(MDGs). The audit examined whether thefinancial and human resources allocatedto the health sector reflected the EC’spolicy commitments and whether theCommission had accelerated the imple-mentation of this aid. The audit alsoassessed how effectively the Commissionhad used various instruments to assist thehealth sector, notably budget support,projects and the Global Fund to fightAIDS, tuberculosis and malaria.

Overall, the report noted that EC fundingto the health sector has not increased since2000 as a proportion of its total devel-opment assistance, despite theCommission’s MDG commitments andthe health crisis in sub-Saharan Africa.While the Commission contributedsignificant funding to help launch theGlobal Fund, it has not given the sameattention to strengthening health systems,although this was intended to be itspriority. The Commission was also criti-cised for having insufficient healthexpertise to ensure the most effective useof health funding.

Although the Commission was found tohave accelerated the health assistance itmanages itself, its rate of disbursement hasbeen slower than for the European Devel-opment Funds (EDF). The report arguesthat there is scope for improving thepredictability of the flow of funding fromall instruments to enable countries tobetter budget the resources available fortheir health sectors.

It also noted that the Commission hasmade little use of Sector Budget Supportin the health sector, although thisinstrument could make an importantcontribution to improving health services.It has used General Budget Support muchmore widely but its links to the healthsector are less direct and the Commissionhas not used it very effectively. Overall,projects have proved reasonably effectivealthough sustainability is often prob-lematic. The Commission played a keyrole in setting up the Global Fund, whichhas already produced significant outputs,but greater involvement by theCommission in Global Fund activities inthe beneficiary countries could have madeit more effective.

The Commission also did not pay suffi-cient attention to ensuring the differentinstruments are used together coherently.When choosing which instruments to use,it could also take more account of thesituation in individual countries, in

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particular whether they had a well definedhealth sector policy.

The report’s main recommendations arethat the Commission should: considerincreasing its aid to the health sectorduring the tenth EDF midterm review tosupport its commitment to the healthMDGs; review how its assistance to thehealth sector is distributed to ensure it isprimarily directed to its policy priority ofhealth systems support; ensure each Dele-gation has adequate health expertise eitherin the Delegation or through drawing onthe resources of other partners; makemore use of Sector Budget Support in thehealth sector and focus its General BudgetSupport more on improving healthservices; continue to use projects, espe-cially for support to policy developmentand capacity building, pilot interventionsand assistance to poorer regions; - workmore closely with the Global Fund inbeneficiary countries; establish clearerguidance on when each instrument shouldbe utilised and how they can best be usedin combination; and make greater effortsto contribute to the development of welldefined health sector policies in benefi-ciary countries.

The report can be accessed athttp://eca.europa.eu/portal/pls/portal/docs/1/2020216.PDF

Injuries killing more than 2,000 childreneverydayIn Geneva on 10 December a joint reportby theWHO andUNICEFwas launchedon child injury prevention. Worldwide,more than 2,000 children die every day asa result of unintentional or accidentalinjuries. Every year tens of millions moreare taken to hospitals with injuries thatoften leave themwith lifelong disabilities.

The World Report on Child InjuryPrevention provides the first compre-hensive global assessment of uninten-tional childhood injuries and prescribesmeasures to prevent them. It concludesthat if proven prevention measures wereadopted everywhere at least one thousandchildren’s lives could be saved every day.

“Child injuries are an important publichealth and development issue. In additionto the 830,000 deaths every year, millionsof children suffer non-fatal injuries thatoften require long-term hospitalisationand rehabilitation,” said WHODirector-General DrMargaret Chan. “The costs ofsuch treatment can throw an entire familyinto poverty. Children in poorer families

and communities are at increased risk ofinjury because they are less likely tobenefit from prevention programmes andhigh quality health services.”

“This report is the result of a collabo-ration of more than 180 experts from allregions of the world,” said UNICEFExecutive Director Ann M. Veneman. “Itshows that unintentional injuries are theleading cause of childhood death after theage of nine years and that 95% of thesechild injuries occur in developing coun-tries. More must be done to prevent suchharm to children.”

Africa has the highest rate overall forunintentional injury deaths. The reportfinds the rate is ten times higher than inhigh-income countries in Europe and theWestern Pacific such as Australia, theNetherlands, New Zealand, Sweden andthe United Kingdom, which have thelowest rates of child injury.

However, the report finds that althoughmany high-income countries have beenable to reduce their child injury deaths byup to 50% over the past 30 years, the issueremains a problem for them, with unin-tentional injuries accounting for 40% ofall child deaths in such countries.

Road traffic related injuries kill 260,000children a year and injure about tenmillion. They are the leading cause ofdeath among 10–19 year olds and aleading cause of child disability.Drowning kills more than 175,000children a year; moreover the profoundlong term consequences (includingpermanent brain damage) of non-fataldrowning mean that it has the highestaverage lifetime health and economicimpact of any injury type. Other majorcauses of injuries include fire-relatedburns which kill nearly 96,000 children ayear, 47,000 deaths due to falls andanother 45,000 children die each yearfrom unintended poisoning.

“Improvements can be made in all coun-tries,” said Dr Etienne Krug, Director ofWHO’s Department of Violence andInjury Prevention and Disability. “Whena child is left disfigured by a burn,paralysed by a fall, brain damaged by anear drowning or emotionally trauma-tized by any such serious incident, theeffects can reverberate through the child’slife. Each such tragedy is unnecessary. Wehave enough evidence about what works.A known set of prevention programmesshould be implemented in all countries.”

The report outlines the impact thatproven prevention measures can have.These measures include: laws on child-appropriate seatbelts and helmets; hot tapwater temperature regulations; child-resistant closures on medicine bottles,lighters and household productcontainers; separate traffic lanes formotorcycles or bicycles; draining unnec-essary water from baths and buckets;redesigning nursery furniture, toys andplayground equipment; strengtheningemergency medical care and rehabilitationservices.

It also identifies approaches that eithershould be avoided or are not backed bysufficient evidence to recommend them.For example, it concludes that blisterpackaging for tablets may not be childresistant; that airbags in the front seat of acar could be harmful to children underthirteen years; that butter, sugar, oil andother traditional remedies should not beused on burns; and that public educationcampaigns on their own don’t reducerates of drowning.

The report is available athttp://www.who.int/entity/violence_injury_prevention/child/injury/world_report/en/index.html

EUROPEAN COURT OF HUMANRIGHTS NEWS

ECHR rules Portugal violated right toprovide abortion services on shipOn 4 February in Strasbourg theEuropean Court of Human Rights(ECHR) passed judgment in the case ofWomen on Waves and Others v. Portugal(application no. 31276/05), concerning thePortuguese authorities’ decision in 2004to prohibit the ship Borndiep, which hadbeen chartered with a view to stagingactivities promoting the decriminalisationof abortion, from entering Portugueseterritorial waters. At that time, abortionwas legal in Portugal only in a few veryrestricted circumstances, including whenthe woman’s life was in danger. Thecountry subsequently eased restrictionson abortion in 2007, allowing theprocedure within the first ten weeks ofpregnancy.

The Court held unanimously that therehad been a violation of Article 10(freedom of expression) of the EuropeanConvention on Human Rights. UnderArticle 41 (just satisfaction) of theConvention, the Court awarded each

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applicant €2,000 in respect of non-pecu-niary damage and€3,309.40 for costs andexpenses.

Women on Waves had chartered the shipBorndiep and sailed towards Portugalafter being invited by two Portuguesenon-governmental organisations, ClubeSafo and Não te Prives, to campaign infavour of the decriminalisation ofabortion. Meetings on the prevention ofsexually transmitted diseases, familyplanning and the decriminalisation ofabortion were scheduled to take place onboard from 30 August to 12 September2004.

On 27 August 2004 the ship was bannedfrom entering Portuguese territorialwaters by a ministerial order, on the basisof maritime law and Portuguese healthlaws, and its entry was blocked by aPortuguese warship. On 6 September2004 the Administrative Court rejected arequest by the applicant associations foran order allowing the ship’s immediateentry.

The court took the view that the non-governmental associations appeared to beintending to give Portuguese womenaccess to abortion procedures and medi-cines that were illegal in Portugal. Theapplicant associations appealed againstthat decision but without success. Theysubsequently applied to the PortugueseSupreme Administrative Court, whichfound that the matter in dispute was notof sufficient legal or social significance tojustify its intervention.

While the ECHR acknowledged the legit-imate aims pursued by the Portugueseauthorities, namely the prevention ofdisorder and the protection of health, itreiterated that pluralism, tolerance andbroadmindedness towards ideas thatoffended, shocked or disturbed wereprerequisites for a ‘democratic society’. Itpointed out that the right to freedom ofexpression included the choice of theform in which ideas were conveyed,without unreasonable interference by theauthorities, particularly in the case ofsymbolic protest activities. The Courtconsidered that in this case, the restric-tions imposed by the authorities hadaffected the substance of the ideas andinformation imparted. It noted that thechoice of the Borndiep for the eventsplanned by the applicant associations hadbeen crucially important to them and inline with the activities which Women onWaves had carried out for some time in

other European States.

The Court observed that the applicantassociations had not trespassed on privateland or publicly owned property, andnoted the lack of sufficiently strongevidence of any intention on their part todeliberately breach Portuguese abortionlegislation. It reiterated that freedom toexpress opinions in the course of apeaceful assembly could not be restrictedin any way, so long as the personconcerned did not commit any reprehen-sible acts.

The Court considered that in seeking toprevent disorder and protect health, thePortuguese authorities could haveresorted to other means that were lessrestrictive of the applicant associations’rights, such as seizing the medicines onboard. It highlighted the deterrent effectfor freedom of expression in general ofsuch a radical act as dispatching a warship.

The Court therefore concluded that therehad been a violation of Article 10, as theinterference by the authorities had beendisproportionate to the aims pursued.

The full judgement is available (inFrench only) athttp://cmiskp.echr.coe.int/tkp197/view.asp?action=html&documentId=846488&portal=hbkm&source=externalbydocnumber&table=F69A27FD8FB86142BF01C1166DEA398649%0D%0A

COUNTRY NEWS

Italy: constitutional and legal fight overright to die moveItaly’s government issued an emergencydecree on 6 February to prevent EluanaEnglaro, who had been in a coma forseventeen years following a car crash,from having her feeding tubes discon-nected.

The case has provoked fierce debate in thecountry. Her father has been battling withthe courts to let her die since 1999,insisting that this was her wish. InNovember, Italy’s highest court ruled thatshe had expressed a preference for dyingover being kept alive artificially, and thatdoctors could stop feeding her.

She was recently moved to a private geri-atric clinic in the city of Udine, wheredoctors had agreed to disconnect herfeeding tubes. But the new decree statesthat feeding “can in no circumstances berefused”. PrimeMinister Silvio Berlusconi

had said that “urgent government inter-vention is needed because this morningthey began the non-provision of food andwater to the person.”

The case puts Mr Berlusconi in directconflict with the courts and PresidentGeorgio Napolitano, who has stated thatthe decree is unconstitutional and hasrefused to sign it into law. Two doctorsquoted in the leading daily Corriere dellaSera said that this “process shouldbecome irreversible” within “three to fivedays”. Eluana eventually died on 9February, the date scheduled for an emer-gency State session, three days afterdoctors began withdrawing life support.

Opinion polls in Italy show the public issplit over this case, although the Vaticanhas been active in campaigning againstattempts to stop feeding Ms Englaro,calling it euthanasia. Euthanasia is illegalin predominantly Roman Catholic Italy,but patients have the right to refuse care.Englaro however has become a symbolfor the Church, which retains a heavyinfluence in Italy, in its campaign againstany reform of the law. Cardinal JavierLozano Barragan, the Vatican’s healthminister, speaking to the La Repubblicadaily said that “to stop giving food andliquids to Eluana is equivalent to abom-inable murder and the Church will notcease to proclaim this loud and clear.” Hiscomments came days after Pope BenedictXVI spoke out against euthanasia arguingthat those in pain should instead behelped to confront it.

Sweden: survey states one in threedoctors in favour euthanasiaOne in every three doctors in Sweden isin favour of the legalisation of euthanasia,according to a new survey presented atthe Global Health in a New Worldconference in Gothenburg in December.35% were favourable to the prescriptionof lethal medicines to patients with anexpressed desire to kill themselves. 40%were against and 25% uncertain,according to a report in the newspaperSvenska Dagbladet.

“We had thought that opposition wasstronger within the medical profession,”said Anna Lindblad, based at theKarolinska Institute (KI) that carried outthe study and interviewed 1,200 practisingphysicians. Psychiatrists and olderdoctors were the groups most positive toallowing euthanasia. Niels Lynöe, aprofessor of ethics at KI, also expressedsurprise at the results of the survey. “It is

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an unexpectedly high proportion ofdoctors which would be prepared to helpby prescribing medicines to these seri-ously ill patients,” he said.

The Swedish state’s medical ethics council(Smer), has recently expressed its supportfor the idea of doctor-assisted suicide.Smer has called on the government toreview the issue but the Minister forHealth and Social Affairs, GöranHägglund, is sceptical.

However, as there are several parties infavour of the legalisation of euthanasia inprinciple, the issue has the potential tothreaten the unity of the coalitiongovernment. One recent poll also foundthat 47% of the general public are also infavour of allowing active euthanasia,according to the magazine Fokus.

England: launch of historic NHSconstitutionOn 26 January an historic signingceremony to mark the launch of the NHSConstitution for England took place atthe Prime Minister’s residence, 10Downing Street. The Constitution, thefirst of its kind in the world, was signedby Prime Minister Gordon Brown,Secretary of State for Health AlanJohnson andNHSChief Executive DavidNicholson.

The Constitution will give power topatients and the public by bringing theirexisting rights together in one place sothey know what they are legally entitledto - and how they can exercise their rightsas well as understanding their responsi-bilities. It also contains a range of pledgesto patients, public and staff, which theNHS is committed to achieving. ForNHS staff, the Constitution will mean anNHS-wide commitment to equippingthem with the tools, training and supportthey need to deliver high quality care forpatients.

Speaking at the launch Minister Johnsonsaid “this is a momentous point in thehistory of the NHS. The launch of theNHS Constitution shows how itsfounding principles still endure today andhave resonance for staff, patients andpublic alike. It will ensure that we protectthe NHS for generations to come.”

A review last summer of the NHS byHealth Minister Lord Darzi, himself adistinguished medic, concluded that therewas a case for an NHS Constitution toenshrine the principles and values of theNHS in England. It is designed to safe-

guard the future of the NHS and renewits core values, making sure it continuesto be relevant to the needs of patients, thepublic and staff in the 21st century.

The Constitution is the result of extensiveconsultation with staff and patients,which was led by strategic health author-ities and overseen by independent expertson the Constitutional Advisory Forum(CAF). In response to the consultationand report published by the CAF, thefinal Constitution includes:

– A right to makes choices about care andinformation to help individuals exercisethat choice

– A new legal right to receive the vaccina-tions that the Joint Committee on Vacci-nation and Immunisation recommendsthat should be received under an NHS-provided national immunisationprogramme

– A right making explicit an individual’sentitlement to drugs and treatments thathave been recommended by the NationalInstitute for Health and Clinical Excel-lence (NICE) for use in the NHS, if theyhave been deemed clinically appropriateby that individual’s doctor.

– A right to expect local decisions onfunding of other drugs and treatments tobe made rationally following a properconsideration of the evidence

– Clear and comprehensive rights tocomplaint and redress.

More information can be found athttp://www.dh.gov.uk/en/Healthcare/NHSConstitution/index.htm

Bill on Autism to be submitted to UKParliamentMP for Chesham and Amersham, CherylGillan, has announced that she will takeforward an Autism Bill in the UKParliament, with the backing of TheNational Autistic Society (NAS) andanother thirteen autism charities. As thefirst name out of the private membersballot, any bill that she puts forwardshould receive sufficient procedural timein Parliament to become law if approvedby her fellow MPs.

Her action is a response to what she seesas local authorities’ complete failure tomeet the needs of the half a millionchildren and adults with autism in theUK, stating that it is “wholly unfair howhard people affected by autism have tofight to get the help they so desperately

need. The continuing postcode lottery ofautism services across the UK is simplyunacceptable and incredibly damaging.Creating the first ever autism law iscrucial to helping local authorities take thenecessary action and recognise theirresponsibilities towards this severelyexcluded group. Many MPs, cross-party,have already offered their support and Ihope many more will back this vitallyimportant bill - it has the potential to radi-cally transform thousands of lives in everyconstituency and community.”

The announcement comes after the NAS‘I Exist’ campaign revealed many youngpeople with autism do not receive thekind of support that would help themachieve their potential in adulthood andat least one in three adults with thecondition are experiencing serious mentalhealth difficulties as a result. Localauthorities have been slow to react;around two thirds of local authorities inEngland do not know howmany childrenwith autism there are in their area and justtwo are aware of the number of adultswith the condition.

The Autism Bill could be the firstcondition-specific private members’ billto be enshrined in law. Mark Lever, ChiefExecutive of the NAS, said that the bill is“a huge step forward in ensuring abrighter future for people with thisserious, lifelong and disabling condition,but we urgently need support to makethis law.Without the right help autism canhave a profound and sometimes devas-tating effect and we will keepcampaigning until we see real change atground level.”

The Bill aims to place a duty on localauthorities and National Health Servicesbodies to recognise and fulfil their respon-sibilities towards people with autism.Measures proposed include: improvinglocal information on the number ofchildren and adults with autism,providing effective support from child toadult services, appropriate staff training,and the promotion of independent livingfor people with the disability.

More information on autism can befound at http://www.autism.org.uk

England: strategy to transform dementiaservicesDementia is one of the main causes ofdisability in later life, ahead of somecancers, cardiovascular disease and stroke.The first National Dementia Strategy in

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England, backed by £150 million over thefirst two years, is intended to increaseawareness of dementia, ensure early diag-nosis and intervention and radicallyimprove the quality of care that peoplewith the condition receive. The strategycalls for specialist memory services to beestablished throughout the country. Thesewill allow people with dementia to havetheir diagnosis made accurately and earlyin the course of the illness, as well as getaccess to treatment and intervention thatcan help them live well with thecondition.

Other initiatives recommended in thestrategy to help the estimated 570,000people with dementia in England, as wellas their carers and families, include bettertraining for GPs in the recognition of theearly symptoms of dementia and access tomemory services throughout the countrystaffed by specialists to provide earlydiagnosis and treatment. Dementiaadvisers will be appointed to help peoplewith dementia and their families navigatethe care and support system throughoutthe illness. Access to older people’scommunity mental health teams, whichhelp assess patients in care homes and tohelp minimise the use of anti-psychoticmedication, will be expanded; whileactions will be taken to increase access toinformation on dementia and to helpremove the stigma associated with it.

The strategy is recognition that thenumber of people with dementia willdouble to 1.4 million in the UK over thenext thirty years and the cost of care andtreatment is likely to triple to over £50billion per year. Direct costs of dementiato the NHS are approximately £3.3 billionper year, with overall costs to the UKeconomy estimated at some £17 billionper year. In launching the strategySecretary of State for Health, AlanJohnson, stated that “in an ageing society,caring for people with dementia is one ofthe most important challenges we face. Iknow that for many people, diagnosis canbe difficult, care can be patchy andwithout adequate support, families can beunder huge stress. All that must change.”

“The creation of a new role of dementiaadvisor will be crucial in making surepeople and families get the help they need.I also want to see GPs trained to recognisethe early symptoms of dementia and beable to refer people with dementia tospecialists who can give an effective diag-nosis. This will allow people withdementia to get the care and treatment

they need and remain as independent aspossible for as long as possible. We owethem, their carers and their familiesnothing less.”

Chief Executive of the Alzheimer’sSociety, Neil Hunt, welcomed theannouncement calling it a “momentousopportunity to avert a dementia crisis thatcould overwhelm the NHS and socialcare”. Also welcoming the launch of theStrategy, Maurice O’Connell, Chairmanof Alzheimer Europe, said, that he wasdelighted “that this long-awaited strategywill now be implemented and thatEngland joins Norway, France andScotland in giving dementia the priority itdeserves. I hope that other nationalEuropean policy-makers take heed andimplement their own national dementiastrategies.”

The Dementia Strategy can be found athttp://www.dh.gov.uk/dementia

Ireland: HSE progress in tackling MRSAin hospitalsThe rate ofMRSA in hospitals nationwidehas fallen according to a Heath ProtectionSurveillance Centre (HPSC) reportpublished on the 29 January, suggestingthat the Health Service Executive is ontrack to meet a five-year target forreducing MRSA rates set in 2007.

The figures relate to Staphylococcusaureus (S. aureus) blood stream infectionsfor acute public hospitals in Ireland.While some patients come into hospitalwith S. aureus blood stream infections,many cases are health care associatedinfections (HCAI). Some of these infec-tions are antibiotic resistant, so calledMRSA (methicillin resistant Staphylo-coccus aureus), and can be more difficultto treat so patients need to be managed toprevent cross infection.

Key findings in the report indicate thatMRSA rates have fallen by 25% from2006 to the latter half of 2008. This is thesecond consecutive report from theHPSC showing a reduction in MRSArates. If this rate of progress is maintained,the HSE could achieve a 30% reductionin MRSA ahead of its five year target.Annually, trends have been downwardsfrom 575 MRSA cases in 2006 to 430again towards the final half of 2008. Thetotal number of S. aureus bloodstreaminfections has also decreased since 2006.

The reduction of HCAI is a key priorityfor theHSE.HCAI, includingMRSA, is achallenge for all health systems as health

care becomes more intensive, complex andinvasive.Welcoming the report HSEChiefExecutive BrendanDrumm said that whilethere is no room for complacency wherehospital infection is concerned, today’sreport showing a reduction in the rate ofMRSA in HSE hospitals confirms that weare making real progress in tackling thisimportant challenge.”

Ireland: HIQA report on hospitalhygieneThe Health Information and QualityAuthority in Ireland launched its secondNational Hygiene Services QualityReview on 22 December. The reviewassessed fifty acute care hospitals againstthe National Quality Hygiene Standardsand provides patients, the public and staffwith detailed information on the hygieneservices in each of these hospitals and theoverall national picture of the quality ofhygiene services across the country.

The review reflects a snapshot in time anddemonstrates that, overall, there has beenan improvement in the quality of hygieneservices as compared to the previous year,with a number of areas identified ashaving improved. These include a multi-disciplinary approach to hygiene services,the structure of hygiene services inhospitals, the management of linen, handhygiene and the management of waste.

However, a number of areas are identifiedthat require further improvement. Theseinclude the evaluation of data andinformation, the monitoring of staff satis-faction, health and wellbeing, reportingtimely and accurate data and information,the development and maintenance ofguidelines for staff and the evaluation ofthe performance of hygiene services staff.

In comparison with the hygieneperformance in last year’s review, the 2008results show that there were nearly twiceas many ‘A’ ratings, the highest level ofcompliance against the standards,awarded across the hospitals this year. Anincrease in ‘B’ ratings was also seentogether with an associated decrease in ‘C’ratings.

“The improvement in the ratings of somehospitals is acknowledged and welcomed.However, a number of hospitals main-tained the same level of performance and,in some, their performance has deterio-rated. Hospitals which scored poorly incore hygiene delivery criteria saw theiroverall rating drop. These hospitals mustwork more effectively to manage the

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necessary improvements in their hygieneservices and the safety of the care theyprovide to patients” said Dr TraceyCooper, Chief Executive of the HealthInformation and Quality Authority.

“The Authority believes that, where poorstandards of hygiene exist in ourhospitals, this should not be tolerated. Weneed to continue to move towards aculture of ‘zero tolerance’ in relation tohealth care associated infections. Strongleadership and management in this areaare vital in order to ensure that highquality standards in hygiene services areoptimum, effective and embedded twentyfour hours a day, seven days a week.”

The Minister for Health and Children,Mary Harney welcomed the report butnoted that not all hospitals had improvedand that there was still too wide a gapbetween those doing well and the underperformers stating that the departmentwas considering “further targeted initia-tives early in the new year to ensure thatthe measurable improvements achieved in2008 are further built upon in 2009. Theaim is that the high standards that havenow been achieved in some hospitals mustbe replicated right across the service.”

The HIQA report is available athttp://www.hiqa.ie/media/pdfs/hygiene/2008/National_hygiene_report_2008.pdf

Germany: Ulla Schmidt warns of healthinsurance cash crunchGermany’s public health care systemcould come up short of cash in 2009. If theeconomy declines, the new universalpremium set by the government mightnot be enough, Health Minister UllaSchmidt said in an interview with theGerman public broadcaster ZDF on 28December.

Minister Schmidt said that she could notsay for certain if the government’s newcommon health premium, currently set at15.5% of the insured’s gross pay, wouldstay at that rate next year. These doubtsover the financing of the Germanstatutory health care system were madepublic just days before reforms to thehealth system came into effect.

If the German economy shrinks by 2%in2009, as many economists are predicting,this would lead to a loss of €440 millionfor the government’s new so-called healthfund, the pool of money from which theinsurers in the future will receive a basicsum to cover their customers. If the15.5% premium rate leads to financing

shortfalls at health insurers, they wouldhave to ask their members to make up thedifference. The government will firstdecide next autumn if the common healthpremium should be raised, Schmidt said.

The universal health premium is part of abroader health care reform package by thegovernment. The amount of money eachinsurer receives from the health fund willnow depend on its members. Thoseinsurers with more chronically ill people,for example, will get more money. Thereform will take contributions from acurrent average of 14.9% of gross pay to15.5%. Health insurance contributionsare generally borne roughly equally bysalaried workers and their employers inGermany.

In the interview Schmidt pointed out thatone of the elements of a second economicstimulus plan under discussion was a taxsubsidy for the new heath fund. This plan,has subsequently been endorsed by theCabinet in January 2009. If approved byParliament this will reduce insurancepremiums from 15.5% back to 14.9% bythe middle of the year.

However Herbert Reichelt, the incominghead of Germany’s biggest public insurerAOK, said he does not believe that the15.5% rate will be high enough for all ofGermany’s public insurers. He predicts ashortfall of between €700 million and €1billion. While his company, AOK, willstay above water with the 15.5%premium rate, he believes others willlikely have to ask their members to makeadditional contributions.

Russia tightens disease control amidbird flu deaths in ChinaIn Moscow on 28 January Russia’s ChiefMedical Officer, Gennady Onishchenko,instructed regional authorities to tightendisease control measures amid a rise in thenumber of bird flu cases in China.According to the World Health Organi-zation, eight cases of human bird fluinfection have been registered worldwidein 2009 – two in Egypt and six in China,where five people have died. However,theWHO said they did not believe Chinawas facing a bird flu epidemic as all thecases were scattered around the countryand appear to be random.

A press statement from his office statesthat he has instructed that quarantinestations at crossings on the Chinese borderbe provided with disinfectants, individualprotective clothing and equipment to

identify people with increased bodytemperature arriving from China andother countries of bird flu concern.Onishchenko also urged improvedmeasures of bird flu vaccinations forpeople working at poultry farms. Diseasecontrol will also be tightened at marketsselling live poultry and pet birds, as wellas at airports receiving flights from Chinaand other bird flu-affected countries.

A total of 399 cases of human infectionwith the deadly H5N1 strain of bird fluhave been registered worldwide since2003. 252 have been fatal. No confirmedcases of human bird flu infection havebeen reported in Russia, although somecases have been seen in domestic poultryin recent years. In the past the Russianauthorities have been quick to act, cullingthousands of birds, placing affected areasunder quarantine, and imposing tightcontrols on battery farms that supplyMoscow with chicken and eggs.

Netherlands: Drugs advisory committeeestablishedThe Dutch Ministry of Health, Welfareand Sport announced on 23 January that acommittee of experts will advise thegovernment on whether Dutch drugpolicy should be modified and, if so, onthe best way of achieving this. Theiradvisory report will be incorporated intothe new memorandum on drugs.

The country’s present drug policy iscurrently the subject of an assessmentstudy. The advisory committee will takestock of the results of this study, and willpresent its report no later than 1 July,2009. The government will present thedrugs memorandum before the end of thesummer recess.

In addition to public health and safety, thegovernment has asked the advisorycommittee to address the social andcommunity aspects of this issue, such asschool drop-outs. The committee will alsolook into the question of whether thestatus of certain drugs on the two lists ofthe Opium Act should be re-examined.List I is for hard drugs, list II for softdrugs. Other areas of investigationinclude: ways of improving preventionand care in the case of addiction; futureoptions for coffee-shop (establishmentsthat are licensed to sell small quantities ofcannabis to adults aged over eighteen)policy; and what action is needed toreduce the Netherlands’ involvement inthe production, transit, and distributionof XTC, cannabis and cocaine.

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Long-term perspective needed to faceimpact of financial crisisThe health sector needs to take urgentsteps to counter the negative conse-quences of the financial crisis on globalhealth. But countries also need to take along-term perspective so their healthsystems are more resilient in the future,said participants in a high-level consulta-tion held at the World Health Organiza-tion, Geneva, on 19 January. Theysuggested five areas of action for WHOand policy-makers: leadership, monitor-ing and analysis, pro-poor and pro-health public spending, policies for thehealth sector based on primary healthcare, and new ways of doing business ininternational health.

More information at http://www.who.int/mediacentre/events/meetings/2009_financial_crisis_report_en_.pdf

Northern Ireland: Prescription chargesreduced from January 2009Prescriptions will cost only £3 per(rather than £7.10 per item) from 1 Janu-ary 2009. The reduction in charges willlast until April 2010, when free prescrip-tions for everyone will be introduced inNorthern Ireland. In Wales, prescriptioncharges were abolished in April 2007,while the Scottish Executive has decidedto introduce a phased abolition of pre-scription charges so that by 2011, therewill be no charges for prescriptions.

England: Prescription chargesabolished for cancer patientsThe English Department of Health hasalso announced that it will abolish pre-scription charges for cancer patients in2009. Up to 150,000 patients already di-agnosed with cancer are expected tobenefit, and may save £100 each year inprescription charges. The changes comeinto effect from 1 April. Prime MinisterGordon Brown has also announced thatin future other patients with long-termconditions will also receive free pre-scriptions. Professor Ian Gilmore, Presi-dent of the Royal College of Physiciansis undertaking a review of prescriptioncharges for people with long-term con-ditions that will report to Ministers insummer 2009.

More information athttp://www.dh.gov.uk/prescriptionchargesreview

eHealth High Level ConferenceAMinisterial Conference ‘eHealth forIndividuals, Society and Economy’ istaking place in Prague on 18–20 Febru-ary 2009 under the auspices of theCzech Presidency. It is focusing mainlyon the impacts of eHealth solutions andprocesses rather than on their techno-logical background, although advancedand accessible information and commu-nication technology is an essential ele-ment of all eHealth concepts.

The programme and otherdocumentation are available athttp://www.ehealth2009.cz

Finland: National Institute of Healthand Welfare LaunchedThe National Institute for Health andWelfare came into being on 1 January2009 following a merger of the NationalPublic Health Institute and the NationalResearch and Development Centre forWelfare and Health (STAKES). It willundertake a range of research and devel-opment, provide guidance and maintaina number of national services, includinginfectious diseases monitoring and act-ing as the statutory statistics authorityfor health and welfare. The new Institutewill maintain and promote close con-tacts with EU bodies, the WHO and anumber of scientific and public institu-tions and agencies, as well as affiliate or-ganisations around the world.

More information athttp://www.thl.fi/fi_FI/web/fi

Newly reported HIV cases on the risein EuropeA joint report from the European Cen-tre for Disease Prevention and Control(ECDC) and the WHO Regional Officefor Europe illustrates that the HIV epi-demic remains a major public healthissue, with evidence of increasing trans-mission of HIV in several countries.Case reporting data from 2007 showthat the number of newly reported casesin the WHO European Region contin-ues to rise. Between 2000 and 2007, theannual rate of HIV infection almostdoubled, from 39 to 75 per million pop-ulation. The highest reported HIV rateswere in Estonia, Ukraine, Portugal andthe Republic of Moldova. In the forty-four countries that have consistentlyprovided data since 2000, the annual

number of newly diagnosed casesincreased from 21,787 to 41,949.

In addition to the surveillance report,detailed data and an analysis of theHIV/AIDS situation in each MemberState are available on both the WHORegional Office websitewww.euro.who.int/aids and the ECDCwebsite www.ecdc.europa.eu

Commission launches consultation onthe future of Europe’s health workforceOn 15 December the European Com-mission adopted a Green Paper on theEUWorkforce for Health. It marks thebeginning of a consultation period thataims to identify common responses tothe many challenges facing a healthworkforce that accounts for about 10%of all jobs in the EU. Many of thesechallenges are common to all MemberStates. The ageing population is chang-ing the pattern of disease and placingnew and increasing demands on healthcare workers. It also means that thehealth workforce is itself ageing, whilethere are insufficient new recruits to re-place those that are retiring or leavingthe EU. Migration of health profession-als into and out of the EU and mobilitywithin the EU also has impacts on thesupply and distribution of healthworkers.

Important issues raised in the GreenPaper include investing in training anddeveloping robust human resourcestrategies to improve recruitment andretention. One such area is, for example,improving the status and participation ofwomen in the health workforce. TheGreen Paper also raises the importanceof balancing how we address shortageswithin the EU with broader globalhealthcare considerations.

Responses to the consultation should bereceived by 31 March 2009. The GreenPaper is available at http://ec.europa.eu/health/ph_systems/workforce_en.htm

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