Vol 13 No 1 - World Health OrganizationHealth Policy Developments 7 Public-private partnerships in...

EurohealthHealth, Technological Development

and the Law

Volume 13 Number 2, 2007RESEARCH • DEBATE • POLICY • NEWS

Regulating nano-technology: new legal challenges?

E-health: but is it legal?

Zsuzsanna Jakab on developments at the EuropeanCentre for Disease Prevention and Control

Dutch health insurance reform: the role of collectives • Palliative care Health service quality in Bulgaria • Experience from public-private partnerships in Eastern Europe

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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 a constructive 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 and Poli-cies.

The European Observatory on Health Systems and Policiesis a partnership between the World Health OrganizationRegional Office for Europe, the Governments of Belgium,Finland, Greece, Norway, Slovenia, Spain and Sweden, theVeneto Region of Italy, the European Investment Bank, theOpen Society Institute, the World Bank, the London Schoolof Economics and Political Science, and the London Schoolof Hygiene & Tropical Medicine.

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Health, law and technologicalchange

The speed of technological advance can be trulybreathtaking; possibilities that a few years ago wereconfined to the realms of science fiction are rapidly becoming reality. Most obviously, the way in whichwe communicate has been transformed beyond allrecognition. We live in a world of instant access,through mobile phones, laptops and PDAs, to the information superhighway. Moreover, social networking platforms, such as Facebook, are beingused to a scale never envisaged by their creators; theirpotential for marketing and brand placement is thesubject of millions of euros of research.

The health sector is not immune from these changes.Not only do we have access to health information onthe internet, albeit sometimes spurious, but we maybook hospital appointments, download personal medical records, use remote diagnostic technologiesand perhaps purchase health care products. Thisgrowth of e-health in all its forms, according to CelineVan Doosselaere and colleagues, has therefore as manyserious implications for health care regulators andlawyers as it does for the medical professions. Theynote the uncertainty about the full legal implicationsof using many e-health applications; further clarification, they argue, at European level is merited.

Having a more flexible legal framework to respond totechnological change can also be applied to the potential use of nanotechnology. As well as ethicalconcerns, resultant legal issues concerning consent,privacy, and use in the context of research remain to befully debated. In this issue Jean McHale calls for an effective and pro-active, rather than reactive, EU response to these new challenges.

Preparedness is a theme also found elsewhere in thisissue of Eurohealth. We are delighted to include a contribution from Zsuzsanna Jakab, Director of theEuropean Centre for Disease Prevention and Control.The ECDC provides some excellent examples of howtechnology may be harnessed to collate and disseminate information on rapidly emerging and un-expected health threats in Europe and beyond.

David McDaid EditorSherry Merkur Deputy Editor

MENT

EurohealthCOM

Contents EurohealthVolume 13 Number 2

Olga Adeeva was until August 2007Research and Development Officer atthe European Observatory on HealthSystems and Policies, Berlin Hub,Germany

Lidia Georgieva is Head of Health RiskManagement, MARSH Bulgaria.

Peter Groenewegen is DepartmentHead, Netherlands Institute for HealthServices Research and Professor ofSocial and Geographical Aspects ofHealth and Health Care at UtrechtUniversity, the Netherlands.

Jean Herveg is Senior Researcher, Centre de Recherche Informatique etDroit, Faculty of Law, University ofNamur, Belgium.

Zsuzsanna Jakab is Director, EuropeanCentre for Disease Prevention andControl (ECDC), Stockholm.

Judith de Jong is a Researcher at theNetherlands Institute for Health ServicesResearch and Head of the Health CareConsumer Panel.

Katja Kerschbaumer is a Junior Professional Associate in the HumanDevelopment Department, Europe andCentral Asia Region at the World Bank,Washington, D.C.

Milton Lewis is Honorary SeniorResearch Fellow, Australian HealthPolicy Institute, University of Sydney,Sydney, New South Wales, Australia.

Jean V McHale is Professor, Faculty ofLaw, University of Leicester, UnitedKingdom.

Denise Silber is Director and Founder,Basil Strategies.

Celine Van Doosselaere is EU AffairsManager, European HealthManagement Association, Brussels.

Petra Wilson is Director Public SectorHealthcare, Cisco.

Health, Technology and the Law1 eHealth…… but is it legal?

Celine Van Doosselaere, Petra Wilson, Jean Herveg andDenise Silber

4 Regulating nanotechnology: new legal challenges?Jean V McHale

Health Policy Developments7 Public-private partnerships in Eastern Europe: Case studies

from Lithuania, Republika Srpska and AlbaniaKatja Kerschbaumer

10 Dutch health insurance reform: the new role of collectivesPeter P Groenewegen and Judith D de Jong

Public Health Perspectives14 Medicine, care of the dying, and care of the chronically ill

Milton Lewis

16 ECDC: Tackling the free movement of microbesZsuzsanna Jakab

European Snapshots19 Promoting the quality of health services in Bulgaria

Olga Avdeeva and Lidia Georgieva

Evidence-informed Decision Making 21 “Mythbusters” Early detection is good for everyone

23 “Bandolier” The case for chocolate

Monitor

24 Publications

25 Web Watch

26 News from around Europe

eHealth is a broad term with many defini-tions, including health informatics, healthtelematics, ICT (information and commu-nication technology) for health, connectedhealth, medical computing, or medicalinformatics, all of which are used todescribe the use of a wide range of infor-mation technology applications andservices in the healthcare setting. For the‘Legally eHealth’∗ study described in thisarticle we use the term eHealth as definedby the Action Plan for a European eHealthArea: “the application of information andcommunication technologies across thewhole range of functions that affect thehealth sector”.1

eHealth is premised on a fundamentallynew patient experience unconstrained byfamiliar points of entry and structures ortraditional channels for delivering infor-mation or care. Not surprisingly therefore,the eHealth revolution has as many seriousimplications for health care regulators andlawyers as for medical professionals,including questions about patient andprofessional identification, maintenance ofpatient confidentiality in an environmentof electronically shared care, as well asquestions of liability for care provided inthis new environment.

In response to the lack of legal certaintyabout the use of eHealth tools, theEuropean Commission, through itseHealth Action Plan, called for a study toestablish a base-line report on existing EUlevel legislation, its impact on the deliveryof eHealth and an analysis of the legal gapswhich may exist. The ‘Legally eHealth’study, which we present in this article, wascompleted in response to that call.

The ‘Legally eHealth’ FrameworkThe one year study, completed in May2007, looked in detail at three particularlegal aspects of using information societytechnologies (IST) in health care: privacy,liability and competition. Although otherlegal issues arise in the context ofproviding health care services usingeHealth tools, we focussed on these threeas the main legal issues with Europeanlevel implications.

We first looked at the key tools and appli-cations and then the main stakeholders andexisting regulations that have an impact onthe use of eHealth. These covered a widerange of information technologies found inhospitals and primary care settings,including administrative tools such ashospital information systems (HIS),summary records and discharge letters;clinical applications of a technical nature

such as picture archiving and communica-tions systems (PACS), as well as clinicalsupport systems such as operating theatresystems (OR), decision support systems(DSS); and systems linking key health careactors such as General PractitionersSystems, and electronic prescribingsystems linking general practitioners (GPs)with pharmacies (eRx).

Having established what concepts andtools were included in eHealth, we nextclassified the stakeholders in eHealth intofour groups of actors: citizens and patients;clinicians and care providers; payers,policy-makers and governments; and,vendors, suppliers and commercialpartners. All four groups of actors havehighly significant but not always equalroles to play in health care. We looked inparticular at the tensions that can arisebetween clinicians and patients withrespect to privacy and confidentiality, orbetween governments and vendors withrespect to competition in the health caremarket.

The study considered the impact ofEuropean data protection legislation,European consumer protection andliability legislation, and European compe-tition law. We analysed this legislation indetail, and followed the analysis by a series

Eurohealth Vol 13 No 21

HEALTH, TECHNOLOGY AND THE LAW

eHealth…… but is it legal?

Celine Van Doosselaere, Petra Wilson, Jean Herveg and Denise Silber

Summary: Unconstrained by familiar points of entry to health care or traditionalchannels for delivering information or care, the eHealth revolution has as manyserious implications for health care regulators and lawyers as for medical professionals. In the context of the Commission’s eEurope Action Plan, the “LegallyeHealth” study established a baseline report on existing EU level legislation, itsimpact on the delivery of eHealth and an analysis of the legal and regulatory barriersand gaps that may exist. This article gives an overview of some of the issues studiedand key recommendations made.

Keywords: eHealth, Security and Privacy, Liability; Data Protection and Ownership

Celine Van Doosselaere is EU AffairsManager, European Health ManagementAssociation, Brussels, Petra Wilson isDirector Public Sector Healthcare, Cisco,Jean Herveg is Senior Researcher, Centre de Recherche Informatique etDroit, Faculty of Law, University ofNamur, Belgium and Denise Silber isDirector and Founder, Basil Strategies. Email: [email protected]

* European Commission contract #30-CE-0041734/00-55. Study on Legal and Regu-latory Aspects of eHealth, ‘Legally eHealth’. Partners in the study include the EuropeanHealth Management Association, the Centre de Recherche Informatique & Droit(CRID) at the Facultés Universitaires Notre-Dame de la Paix (Namur, Belgium), andBasil Strategies. Special thanks are due also to Cisco Systems Internet Business SolutionsGroup who gave technical input and writing support. Further details on the Study canbe obtained from EHMA (www.ehma.org) or European Commission(http://ec.europa.eu/information_society/activities/health/studies/index_en.htm)

of small case study ‘vignettes’ whichdemonstrated the practical implications ofthe key legal concepts. Key legal aspectsstudied in the ‘vignettes’ included:

Electronic Medical Records– responsibility of the service provider to

the physician– responsibility of the physician to

his/her patients

Sale of medical products on line– responsibility of the manufacturer's

website– responsibility of the consumer

Distance monitoring products– responsibility of the manufacturer, – responsibility of the service provider

Using digital records pedagogically– protecting patient anonymity

eHealth industry– role of the state versus private sector– monopoly and competition

We concluded with recommendations tothe European Commission on furtherregulatory activities to support the imple-mentation of eHealth.

In this article we outline the three legalaspects we studied and the key recommen-dations made.

On data protectionThe study looked in detail at the require-ments of EU privacy and data protectionlegislation, providing a thorough exami-nation of the Data Protection Directive(95/46/EC) and the Directive on Privacy inElectronic Communications (2002/58/EC).

We looked carefully at the existing regula-tions and concluded that while the Direc-

tives are probably sufficient to meet theneeds of IST in health, further clarificationof specific legal duties would be helpful.Data protection legislation is now wellestablished in Europe: while health data isalways sensitive and requires specialprotection, such data may be processed onthe basis of patient consent; or in the vitalinterests of the patient; or for the purposeof medical diagnosis and care provision; or,in certain cases, if there is a substantialpublic interest in such data processing.

We believe that generally the existing dataprotection legislation at EU level and itstransposition at Member State level aresufficient to allow eHealth tools and appli-cations to be used efficiently in health care.However, we recommended that theEuropean Commission and Member Statescooperate, in particular through the DataProtection Working Party set up underArticle 29 of the Data ProtectionDirective, to address uncertainties in therole of consent to the processing ofmedical data; the necessity to state afinality of purpose for data collection; andtechnical aspects of data processing andstorage security.

There are particular difficulties connectedwith the concept of ‘consent’ in healthrelated data processing. A particularproblem with consent lies in the fact that,in order to be valid, consent must be freelygiven. Thus, if the creation of electronicmedical records is a necessary andunavoidable aspect of providing goodquality health care, then withholdingconsent may be to the patient’s detriment.We argue therefore that it would seemappropriate for the European Commissionto coordinate the adoption of specific rulesfor the processing of health information

that allows for proper balancing ofpatients’ and public health interests,without recourse to the concept of consent.

On eHealth and product liabilityTraditionally, medical liability is restrictedto the relationship between the patient andthe health practitioner (usually a doctor).When a patient is a victim of medical negli-gence or of a medical error, he or she willusually seek to introduce a civil or criminallawsuit against the doctor. However, theuse of eHealth tools, as well as the multi-plication of intermediaries in the field ofhealth services, is changing the legal rela-tionships between the various actors, andoften makes it more difficult for a patientto know where liability lies if somethinggoes wrong.

Although general legal rules have beenagreed to provide consumers with a legalguarantee of high quality products andservices, the legal texts do not specificallyaddress health or eHealth. The current EUlevel law is applied within the generalcontext of service provision and productdelivery, whether by traditional or elec-tronic means. As a result it is often difficultto ascertain which EU level legislationapplies to an eHealth product: is itconsidered a medical device, a softwarepackage, and does other legislation (forexample, on hazardous substances) alsoapply? In terms of health goods, whethereHealth or traditional, standard contractsfor sale of goods will apply. In generaltherefore in the eHealth arena, thepurchaser of an eHealth good will need tomake reference to the relevant nationallegislation based on Directive 1999/44/ECon the Sale of Consumer Goods.

The study concluded that while specificeHealth sale of goods legislation isprobably not needed, it might be appro-priate to consider the adoption of specificEU level guidelines on the sale of eHealthgoods in order to encourage the adoptionof EU wide markets in eHealth toolsrather than the fragmented national levelmarkets one sees currently.

Beyond the sale of the product, Directive2001/95/EC on General Product Safetyrequires that any product put on themarket for consumers, or likely to be usedby them, is safe. Further it requires thatproducers provide consumers with therelevant information enabling them toassess the risks inherent in the product,and take appropriate actions to avoid theserisks (withdrawal from the market,warning to the market consumers, recall

Eurohealth Vol 13 No 2 2


products already supplied etc).

National authorities have been establishedto monitor product safety and to takeappropriate measures to protectconsumers and an information system hasbeen put in place which imposes collabo-ration not only between distributors,producers and the national authorities butalso between Member States and theEuropean Commission (RAPEX).2 Thissystem has thus far not been used well (if atall) for eHealth products, which are stillrather new and for which little legalguidance currently exists. Accordingly, thestudy recommended that the EuropeanCommission should adopt policy tools toencourage the use of the RAPEX systemfor eHealth products.

We also noted also that some eHealthproducts are considered medical devices,in the terms of Directive 93/42/EC onMedical Devices. The Directive includes inits definition of medical devices electronicequipment and software manufactured orpromoted for medical purpose. Thus,monitoring devices, for example, could beconsidered as medical devices under theEuropean Medical Device legislation,while eHealth tools used for the adminis-tration of general patient data willgenerally not be considered medicaldevices unless such a product (for example,a laptop, printer, screen, etc.) has had aspecific medical purpose assigned to it.

It is clear that more clarity is needed on theextent to which eHealth products arecovered by Medical Devices Legislation.Many of the currently available moni-toring devices are covered only by generalproduct liability, not by a specific liabilityprovision. It is suggested that furtherconsultation on the application of medicaldevices legislation to eHealth tools takesplace to establish if special guidelinesshould be issued.

On competition lawHealth services, in most European coun-tries, are provided at least to some extentthough direct taxation and compulsoryhealth insurance. However, most eHealthservices are offered through private enter-prises and businesses and thus eHealth

poses difficult questions concerningcompetition within public and privatemarkets in situations where the distinctionbetween the two is often very hard toestablish.

The principles of free trade and freecompetition are among the most importanteconomic principles supported by theEuropean Community. It is therefore notsurprising that the European Communityhas adopted a wide range of legislation tosupport free competition through a legalsystem that prohibits any disloyal practicesthat restrict competition.

The core of European competition law isfound in the rules applying to private firmsor ‘undertakings’ in Articles 81 and 82.Article 81 prohibits agreements andconcerted practices with an anticompet-itive objective or effect on the market,while Article 82 prohibits abuse of adominant position. Article 86(2) states thatthe rules on competition also apply topublic undertakings, as long as the “appli-cation of such rules does not obstruct theperformance, in law or in fact, of theparticular tasks assigned to them.”

The rules of competition law on abuse ofdominant position and concerted practicesare defined by the Treaty to apply only tothose organisations classified as ‘under-takings’. The key question for purposes ofhealth care providers is therefore whetherany of the parties to an eHealth service aredeemed to be undertakings and thereforesubject to competition law.

Recent case law at national and EU level3

has established that publicly funded healthbodies may, in certain circumstances, besubject to competition law. However, thecase law is unclear and would seem toprovide that the same institution may, insome aspects of its conduct, be regarded asan undertaking (if it offers goods orservices on the market) but in other aspects(such as contracting out certain careservices) will not be considered an under-taking.

This ambiguity in law will be unsettling forboth public and private sector health careproviders. The study recommended,therefore, that the appropriate committees

of the European Commission should beencouraged to examine the recent decisionsof the European Court of Justice (ECJ) onthe application of Articles 81 and 82 tohealth care providers, in order to draw upclear guidelines establishing when a healthcare provider will be regarded as an under-taking and when not. Such guidelinesshould address the widest possible range ofhealth care providers and suppliers,covering traditional and eHealth care.

Further to Article 86(2), the Treatyprovides that an undertaking normallysubject to the rules of competition law maybe exempted from their application if it hasbeen entrusted by a public body to providea Service of General Economic Interest(SGEI)4 and if the application of the ruleson competition would obstruct theperformance of the particular tasksassigned to them. While it is left up toMember States to define the services theyconsider as SGEI, considerable lack ofclarity still exists at EU level on the desig-nation of health services.

Recognising that many European healthsystems are provided through publicfunds, the European Commission has, in anumber of communications, suggested thathealth services are not generally to beregarded as SGEI nor are they to beincluded in the wider definitions ofServices of General Interest (SGI) or SocialServices of General Interest (SSGI)*. TheCommission has instead proposed that,because health services have such a uniquecharacter, special targeted rules on healthservices of general interest should be estab-lished. However, despite first raising thisissue in 2001, the European Commissionhas yet to clarify the position of healthservices and their possible exemption fromcompetition law.

The study recommended that theCommission adopt a communication orguidelines setting out clearly the circum-stances under which a health serviceprovider may make use of the provisionson SGEI in the Treaty and thus beexempted from competition law. Suchguidelines should address the changingnature of health services, recognising that awide range of actors from both public and



* For the evolution of the definition on Services of General Interest, see Green and White Papers at http://europa.eu/eur-lex/en/com/gpr/2003/com2003_0270en01.pdf (COM(2003) 270 final, May 2003) and http://europa.eu/eur-lex/en/com/wpr/2004/com2004_0374en01.pdf (COM(2004) 374 final, May 2004), announcing a more systematicapproach in the field of social and health services of general interest. This systematic approach is proposed by a Communication fromthe Commission ‘Implementing the Community Lisbon programme: Social services of general interest in the European Union’(COM(2006)177, April 2006), available at http://ec.europa.eu/employment_social/social_protection/docs/com_2006_177_en.pdf. For more information, see http://ec.europa.eu/employment_social/social_protection/questionnaire_en.htm.)

private enterprises will be involved in theprovision of both traditional and eHealthservices. In order to encourage adequateinvestment in eHealth services, both publicand private enterprises must have legalcertainty on their position with respect tocompetition law.

ConclusioneHealth is important for Europe, it candrive up service quality, improve patientsafety, contain costs and facilitate access tohealth care. The ‘Legally eHealth’ studyhas examined aspects of European lawrelated to data protection, liability andconsumer protection, and competition law.It has identified that a significant body ofEuropean law already addresses a numberof the key legal issues in eHealth.However, there is still great uncertainty inthe eHealth actors, ranging across publicbodies, big industry and small enterprisesabout the full legal implication of usingand offering eHealth services.

It is notable that despite the large numbersof communications on Services of General

Interest, the Lisbon agenda and long-termcare, as well as heated debates on healthservices with the Services Directive, littleemphasis has been given to an impactassessment of the proposed legislativeresponses to health services in general.Moreover, none have considered in depththeir impact on eHealth services. Givenhowever, that the development of eHealthmarkets is considered to have majoreconomic potential for Europe,5 furtherlegal clarifications are necessary both toencourage the development of thesemarkets in optimal conditions, all thewhile respecting the unique nature ofhealth services. Therefore, in addition tothe specific recommendations made oneach of the three clusters of legal issues, thestudy calls for a mainstreaming of eHealthimpact assessment across all Europeanpolicy initiatives.

REFERENCES

1. Commission of the European Commu-nities. eHealth: Making Health CareBetter for European Citizens – An Action

Plan for a European eHealth Area.Brussels: Communication from theCommission to the Council, the EuropeanParliament, the European Economic andSocial Committee and the Committee ofthe Regions, COM(2004)356, 2004.

2. See http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm

3. Federación Nacional de Empresas deInstrumentación Científica, Médica,Técnica y Dental (FENIN) v Commissionof the European Communities. Court ofFirst Instance (EC), Case T-319/99, Courtof Justice of the European Communities,Case C-205/03.

4. Commission of the European Commu-nities. Services of General EconomicInterest, summaries of legislation. Availableat http://europa.eu/scadplus/leg/en/lvb/l26087.htm

5. Independent Expert Group on R&D andInnovation. (Esko Aho chair). Creating anInnovative Europe. Luxembourg: Officefor Official Publications of the EuropeanCommunities, 2006. Available athttp://ec.europa.eu/invest-in-research/pdf/download_en/aho_report.pdf



Regulating nanotechnology:new legal challenges?

Jean V McHale

Summary: The development of nanotechnology has huge potential for medical science. However atthe same time it gives rise to a range of legal and ethical regulatory challenges for the EU andMember States. This paper explores first what is meant by nanotechnology and its use in medicine.Secondly, it considers some of the ethical and regulatory challenges discussed by the EuropeanGroup on Ethics in Science and New Technologies in their recent Opinion on the ethical aspects ofnanomedicine. It suggests that there are many legal and ethical issues which will need to be furtherexplored at both EU and Member State level, including the diversity of current regulatory structures applicable in this area, issues of consent, privacy and the regulation of risk.

Key words: Nanotechnology, Medicine, Health, Law, European Union

The rise of nanotechnology in general andnanomedicine in particular has led toconsiderable debate and controversy.1

‘Nanotechnology’ can enable us to better

understand how the body functions atmolecular level. ‘Nano’ itself refers to ‘onebillionth’ and originates from the Greekword meaning ‘dwarf’. As the EuropeanTechnology Platform Report comments:

“It is an extremely large field ranging fromin vivo and in vitro diagnostics to therapyincluding targeted delivery and regener-

ative medicine. It has to interface nanoma-terials (surfaces, particles or analyticalinstruments) with ‘living’ human material(cells, tissues and body fluids). It createsnew tools and methods that impact signif-icantly on existing conservative prac-tices”.2

The development of this technology may

Jean V McHale is Professor, Faculty ofLaw, University of Leicester, UnitedKingdom. Email: [email protected]

result in more efficient interventions inrelation to illness.3 Nanotechniques caninvolve the use of technologies which aremore cost-effective and accurate, such asthe ability to enhance resolution to asingle-molecule analysis of any sample.Nanowire arrays enable testing of a singlepinprick of blood. This reduces theprospect of invasive procedures but stillenables efficient testing results and canenable such tests to be undertaken at homeeasily and with little pain.2

Use of nanotechnology in imaging, such asultrasound, may result in a much moreprecise diagnosis. The use of miniaturisedimaging systems makes it possible forimage-based diagnosis to be undertaken,not simply in research centres, but muchmore widely. This has the advantage ofpotentially enabling the earlier detection ofdisease, with a consequent need for lessinvasive and lower cost treatments.2

Nanotechnology also enables the devel-opment of miniature devices which may beused in treatment itself. This can reducethe invasiveness of procedures and lead tothe development of new forms oftreatment.

Nanopharmaceuticals may deliverparticular molecules through biologicalbarriers such as blood-brain barriers.Carriers on the shell of these molecules canbe targeted at molecules which are typicalfor cancer. Nanotechnology may also facil-itate regenerative medicine. It may enablethe improvement of the activation of geneswhich stimulate regeneration, throughstem cell therapy with nanotechnologybased upon magnetic cell sorting identi-fying/activating and guiding stem cells tothe particular part of the body which needsregenerating. There is also the prospect ofcontinuous medication through implantswith controlled administration of drugsover a period of time. In addition, accessto nanotechnology may also facilitatetissue engineering.2

But is nanotechnology really ‘somethingnew’? As has been commented:

“In many cases nanotechnology includestechnology which has been in use for along time and most of the concepts usedare not strictly speaking new. For instance,the mode of action of all pharmaceuticalproducts occurs at nano scale. Nanomed-icine essentially provides tools that may beuseful for well identified medicalproblems.”3

Nonetheless, although not totally new, it

is the scale of nanotechnological devel-opment and the wide range of issues withwhich nanotechnology is concerned,which may give rise to notable regulatorychallenges. Developing technologies giverise to issues of legitimacy and the need toensure public trust and confidence, as wehave seen in the context of the debates overembryo research and stem cell technology.

Nanotechnology and the EU The immense potential of nanotechnologyin general, and that in relation to health inparticular, has already been identified bythe European Union. The EU has beenresponding to the challenges of nanotech-nology. In 2004 the Commission issued theCommunication Towards a Europeanstrategy for nanotechnology.4 This iden-tified the potential of nanotechnology butalso recognised its risks and the need forthe early identification and resolution ofsafety concerns.

It noted the need for effective research anddevelopment support. It stressed the needfor effective coordination of nationalmeasures through mechanisms such as the‘Open Method of Co-ordination’. It wasrecognised that there was a need for a“world class infra structure” with “polesof excellence”. This document also high-lighted the need for recognition of ethicalprinciples in accordance with the EUCharter of Fundamental Rights andFreedoms and other European and inter-national documents.4

It also identified the need for effectivecommunication of such informationwithin the scientific community. Inaddition, the Communication noted theimportance of international cooperation. Itsuggested that there should be an interna-tional debate on those matters of globalconcern, including public health, safety,the environment, consumer protection,risk assessment, regulatory approaches,methodology, nomenclature and norms”.4

Ethical reviewThe European Technology Platform onNanomedicine, an industry-led con-sortium, brought together the key stake-holders in the area to examine the impactof nanotechnology.2 As part of theCommunication from the Commission tothe Council, the European Parliament andthe Economic and Social Committee,entitled Nanosciences and nanotech-nologies: an action plan for Europe 2005–2009, the European Group on Ethics inScience and New Technologies were asked

to undertake an ethical review ofnanomedicine which would enable thefuture appropriate ethical review ofproposed projects concerning nanoscienceand nanotechnology.5

Theis Expert Group highlighted oneuncertainty in this area, namely that therewas no clear legal definition of nanomed-icine.3 They also identified a major prac-tical problem in attempting to take aholistic approach to the regulation ofnanotechnology, namely that there is adiverse range of forms of legal regulationof such technologies. So, for example, atEU level regulation of nanotechnologymay arise in the context of the regulationof pharmaceuticals6 or medical devices7

where other health care law principles areapplicable, such as consent, confidentialityand data protection.8 It was not necessarilyalways obvious which precise regulatoryregime would apply.

One notable concern regarding the devel-opment of nanotechnology is that ofsafety. A United Nations Education Scien-tific and Cultural Organization report onthe ethics and politics of nanotechnologycommented that the question of safety ofnanotechnology and nanomedicine raised:

“two concerns: the hazards of nanopar-ticles and the exposure risk. The firstconcerns the biological and chemicaleffects of nanoparticles on humanbodies or natural ecosystems; thesecond concerns the issue of leakage,spillage, circulation, and concentrationof nanoparticles that would cause ahazard to bodies or ecosystems”.9

There are concerns that there may be a riskof toxic effects to patients. There is also thepossibility of side-effects to patients wherenanomedicines cross blood-brain barriers.It has also been suggested that there arehealth-related risks from the effects ofnano-pollution on the environment. TheEuropean Ethics Group recommendedthat there should be more research into thesafety of nanomedical products/devices.3

The Group was of the view that withoutstrategic risk research public confidence innanotechnologies could be reducedthrough real or perceived dangers. It wasimportant for the relevant authorities toassess the risks of nanomedicine and thatboth national and EU bodies concernedwith safety of patients and citizens shouldreview the safety of nanotech devices.

While the European Ethics Group recog-nised a range of regulatory issues, theyrejected the introduction of a new broad



regulatory structure for nanomedicine.Instead it was thought that changes shouldcome from within existing structures.3

However, they were concerned withensuring that the differences within therange of regulations already in existencewould be addressed by regulatory bodies.It was noted that while many of theproblems associated with new materialsare addressed through product liabilitylegislation, at the same time there are diffi-culties in ascertaining the risks and relatedliability from negligence. Further concernsrelate to the use of patenting in hinderingthe therapeutic availability of such technology.

The Group also expressed their concern atthe prospect of internet tests usingnanotechnology becoming available. Theysuggested that in the interest of consumerprotection, policies should be developed tomonitor the introduction of tests directlymarketed to customers.3 As with any newtechnology, there are also challenges inrelation to nanotechnology in terms of theprovision of information as part of an‘informed consent’ process.

The Expert Group emphasised the needfor transparency and public trust. Recog-nising the on-going nature of the chal-lenges faced by nanotechnology, theGroup suggested that there was a need forinter-disciplinary research on the ethical,legal and social implications of the tech-nology. They proposed that there shouldbe a dedicated European network onnanotechnology ethics, established andfinanced by the Commission under theSeventh Research and DevelopmentFramework Programme.

They also suggested that initiatives shouldbe developed to enhance informationexchange between research ethicscommittees in different Member States.Interestingly, the report also suggests thatmeasures should be taken at a Europeanlevel to create databases not only for scientific aspects of nanomedicine but alsofor their ethical, legal and social implica-tions.

One other concern raised by the ExpertGroup was the prospect of any overlapbetween medical and non-medical uses.3

They noted that there was a possibility that

“the distinction between therapeuticgoals and enhancement goals maybecome less clear, if for example, predis-position tests are available more easilyand cheaply. Especially in the repro-ductive context of pre-implantation

genetic diagnosis the line between‘negative’ and ‘positive’ selection maybe blurred.”

The Group noted that, in future, it may bethe case that neurological stimulation ofbrain activity goes beyond therapeutic anddiagnostic use. The Group suggested thatappropriate monitoring and guidelines asto the use of nanotechnology in thisparticular area should be introduced. Theywere also of the view that priority shouldnot be given to “enhancement tech-nologies”, rather health care concernsshould first be addressed.

ConclusionsWhere do we go from here? Nanotech-nology does have great potential, but is ittruly ‘special’ and different? The answer tothis question is surely both yes and no.10

Yes because it is a new technology withpotential new risks, but at the same time inother ways it can be seen as not being thatnew at all. It is derivative upon regulationacross a wide range of different areas andthis will, clearly in itself, give rise toparticular regulatory challenges.

The report of the European Group onEthics in Science and New Technologiesraises a series of important issues whichneed to be addressed. Nanotechnology isincluded in the Seventh Research andDevelopment Framework programmeunder the theme ‘Nanosciences,Nanotechnologies, Materials and NewProduction Technologies’.11

Both at EU and Member State level, thereis a need for prioritisation betweendifferent types of nanotechnology. Thelines between therapeutic and non-therapeutic uses will pose challenges.Ethical concerns over the implications ofnano-scale implants, such as brain implantsin relation, for example, to issues of impacton autonomy, integrity, self-identity andfreedom will need further exploration.

Equally, the resultant legal issuesconcerning consent, privacy, and use in thecontext of research remain to be fullydebated. The challenge, as with other newtechnologies such as embryo research andstem cell therapy, is to balance publicdemand for the development of newmedical therapies with public concernsregarding the risks that these new tech-nologies entail. An effective pro-active, asopposed to reactive EU response, is to bewelcomed in dealing with these challengesacross the Member States of the EU.

REFERENCES

1. Hunt G, Mehta M. Nanotechnology,Risk, Ethics and Law. London: Earthscan,2006.

2. European Technology Platform.Nanomedicine: Nanotechnology for HealthBrussels: European Technology Platform,2006. Available atftp://ftp.cordis.europa.eu/pub/nanotech-nology/docs/nanomedicine_bat_en.pdf

3. European Group on Ethics in Scienceand New Technologies to the EuropeanCommission. Opinion on the EthicalAspects of Nanomedicine. Brussels:Opinion No 21, January 17 2007. Availableathttp://ec.europa.eu/european_group_ethics/activities/docs/opinion_21_nano_en.pdf

4. Commission of the European Commu-nities. Towards a European Strategy forNanotechnology. Brussels: Commission ofthe European Communities, COM 338,May 2004. Available athttp://ec.europa.eu/nanotechnology/pdf/nano_com_en_new.pdf

5. Commission of the European Commu-nities. Nanosciences and Nanotechnologies:An Action Plan for Europe 2005–2009.Brussels: Commission of the EuropeanCommunities, COM 243, 2005. Availableat ftp://ftp.cordis.lu/pub/nanotech-nology/docs/nano_action_plan2005_en.pdf

6. See Regulation (EC) 726/2004

7. See Directives 93/42/EEC and90/385/EEC.

8. See Directive 95/46/EC

9. United Nations Educational, Scientificand Cultural Organization. The Ethics andPolitics of Nanotechnology. Paris:UNESCO, 2006. Available athttp://unesdoc.unesco.org/images/0014/001459/145951e.pdf

10. Royal Society and Royal Academy ofEngineering. Nanoscience and Nanotech-nologies: Opportunities and Uncertainties.London: Royal Society and the RoyalAcademy of Engineering, 2004. Availableat http://www.nanotec.org.uk/finalReport.htm

11. Commission of the European Commu-nities. Proposal for a Decision of theEuropean Parliament and of the CouncilConcerning the Seventh FrameworkProgramme of the European Communityfor Research, Technological Developmentand Demonstration Activities. Brussels:Commission of the European Communities, COM 119, April 2005.



Many countries are looking at variousforms of public-private collaboration(PPC) in order to support reforms andimprove efficiency and fiscal sustainabilityin the publicly financed health sector. Todate, there is limited information availableon the different options for PPC, inparticular on reasons for success, thenecessary institutional and financialrequirements and ways to manage therelated financial risk.

PPC in the health sector can take a varietyof forms, with differing degrees of publicand private sector responsibility and risk.They are characterised by the sharing ofcommon objectives, as well as risks andrewards, as might be defined in a contractor manifested through different arrange-ments, so as to effectively deliver a serviceor a facility to the public.

Health care public-private partnerships(PPP) typically involve the Ministry ofHealth or the national health insurersigning a contract with the private sectorfor a specific service. PPPs can be applied

to a wide range of clinical and ancillaryservices, such as design and construction,catering, laundry, clinical support services(for example, laboratory analysis) andspecialised clinical services (for example,haemodialysis). It may even be used tooutsource the management of an entirehospital.

Contracts may stipulate that the privatesector be responsible for all or someproject operations; financing might beundertaken jointly or by either the publicor private sector alone. In practice, themain types of PPP frequently encounteredin the health sector include: concessioncontracts (in which asset ownershipremains in public hands, but where theprivate partner is responsible for newinvestments, as well as operating and main-taining assets), management and servicecontracts, leases, the creation of brand newjoint venture projects or privatisation.

The following three case studies reportinitial experiences with public-privatearrangements in South-Eastern andEastern Europe.

Clinic concession contracts in Vilnius,LithuaniaA major problem in hospitals in themunicipality of Vilnius had been theshortage of funds for essential maintenanceand renovation, as well as for the purchaseof modern information technology andmedical equipment. Waiting times forappointments and surgery were alsodisproportionately long. Medicalpersonnel were not very motivated, due toa lack of direct responsibility or incentives.

There were however public concerns overany suggestion of reforming the system,because of the discovery of a corruptionscandal in 2004 related to the proposedestablishment of a PPP clinic in Kaunas.Doctors were also key opponents ofreform; they feared losing their privileges,including informal payments from theirpatients. These negative attitudes wereovercome through ongoing meetingsbetween representatives of the munici-pality, doctors and patients, as well asthrough a major information campaign inthe press and television. Most importantly,


HEALTH POLICY DEVELOPMENTS

Public-private partnerships inEastern Europe: Case studies from Lithuania, Republika Srpska and Albania

Katja Kerschbaumer

Summary: Public-private partnerships (PPP) in the health sector have become aviable tool for governments seeking to reduce financial pressure without loweringquality standards and unreasonably burdening patients. Lithuania, Bosnia andHerzegovina, and Albania have successfully established several partnerships with the private sector. Key factors for a PPP’s success include: the active involvement ofpatients and medical staff, an enabling legislative framework, the conduct of feasibility studies and the introduction of performance control mechanisms.

Keywords: Public-Private Partnership, Health Care, Concession Contracts,Outsourcing, Lithuania, Republika Srpska, Bosnia and Herzegovina, Albania

Katja Kerschbaumer is a Junior Professional Associate in the HumanDevelopment Department, Europe andCentral Asia Region at the World Bank,Washington, D.C. Email: [email protected]

* On 4–5 December 2006, The World Bank, together with the International FinanceCorporation advisory and investment team and the Slovenian Center of Excellence inFinance, organised a two-day workshop on public-private collaboration in health. Thisarticle is based on three case studies that were presented by country representatives at theworkshop. Background material as well as all presentations given at the workshop canbe found on the Bank’s website: www.worldbank.org.

meetings between private investors andmedical personnel allowed trust betweenthe two groups to develop. Given the factthat Lithuania is facing a major lack ofhealth care professionals because ofmigration to other European Union coun-tries where salaries are higher, it wascrucial to reach consensus with theseprofessionals.

Through a selection process, the munici-pality of Vilnius chose two of eightpotential clinics for the introduction ofPPP. There were no firm criteria for thisselection; the municipality simply wantedthe clinics to be ‘representative’ withregards to their size and economicperformance. Thus, one large and onesmall clinic, both of average performance,were chosen. In addition, in order toensure that the population would notavoid using those hospitals where reformswould be introduced, politicians choseclinics located in areas without easy accessto alternative health care providers.

The municipality of Vilnius also hiredconsultants to carry out a feasibility study,including a patient survey in 2005/06. Thestudy evaluated ten different options forcollaboration with the private sector: theseinvolved various combinations ofcontracting out maintenance and/ormedical services, privatisation andoutsourcing of management. According tothe study, only private sector participationthat included several different activitieswas financially viable.

The contract put out to tender thusincluded the renovation and maintenanceof clinic buildings as well as administrativeand health care services. A two yeartimetable was put in place to issue theconcession. This would run for 25 years,with each clinic needing to reach 30,000patients to break even. The investment intoone clinic from the successful conces-sionaire, a Lithuanian firm registered inCyprus, is €4 million. The firm is projectedto start making a profit in eight years.

It is expected that the new arrangementswill lead to an increase in the number ofpatients per doctor and the installation of apatient registration system by the privateinvestor. This registration system will beslowly extended by the Ministry of Healthto all clinics in Lithuania. It is also antici-pated that a decrease in waiting times fromtheir current level of 40 minutes to (even-tually) 15 minutes will also lead to anincrease in patient satisfaction.

These PPP contracts are expressly labelled

as ‘concession contracts’, with the wholeprocedure largely governed by theLithuanian Law on Concessions. In thecase of the above clinic, the contract was50 pages long and signed by four parties:the director of the municipality’s adminis-tration, the concessionaire, the firm estab-lished by the concessionaire and the clinicdirector. An administrative committee wascreated by Vilnius municipality tosupervise the process of drawing up thecontract.

A key challenge in this project was thatsome (very limited) property rights in theclinic building and equipment were held bythe Ministry of Health rather than themunicipality. This made it impossible forthe municipality to lease these assetsdirectly to the ‘Special Purpose Vehicle’(SPV – a limited company set up to fulfil anarrow objective and legally isolate a highrisk project from a parent company set upfor the contract). However, the Ministry ofHealth instead was able to enact legislationtransferring these limited property rightsto the municipality who in turn could leasethis to the SPV.

Some would have liked to have gone evenfurther than these arrangements to leasefacilities to the private sector. The advisorto the mayor of Vilnius called theconcession contract a ‘second-bestsolution’, suggesting that the clear desirableoption would have been privatisation. Sucha view however was not reconcilable withthe views held by the general public, and inparticular by health service users, thathealth care provision should be a coreresponsibility of the state alone.

Specialist dialysis services in Banja Lukaand Bijeljina, Republika Srpska, Bosniaand HerzegovinaThe dialysis centres of Banja Luka andBijeljina provide another example of howindividual clinic services can be out-sourced. The PPP process benefited fromno opposition from either the public orgovernment. Indeed, patients were verysupportive and even went to theconstruction sites to witness progress andenquire as to when the new centres wouldbe ready.

Thus a contract was signed by the PrimeMinister, the Minister of Health, the

Minister of Foreign Economic Affairs, theHealth Insurance Fund Director, thehospital director and successful bid winner– the Dutch firm International DialysisCenter (IDC).* The contract itself wasvery simple and only eight pages long.From a legal standpoint, the outsourcingof dialysis services could be undertakenwithout the need to pass new laws or useother legal instruments. This could beachieved simply through a contract withthe services provider, supported by lawsgoverning companies with limited liabilityand foreign companies.

Republika Srpska (RS) first began usingthe PPP contractual model in 2000. As theNational Health Insurance Fund did nothave a specific estimate of costs oftreatment provided in the statehaemodialysis centre an economic analysiswas conducted. This found that treatmentcould in fact be obtained at a lower pricein the private sector. Based on this finding,the Government of RS decided to collab-orate with private health care institutions,being mindful of three objectives:improvements in the quality of thenational health care system; increasedaccess to high quality medical services; andcost reduction within a self-sustaininghealth system.

The direct investment now made by IDCincludes the renovation of the existinghaemodialysis centre in Banja Luka andthe construction of a brand new buildingfor the Bijeljina Centre. The totalinvestment made by IDC for construction,reconstruction and all medical and non-medical equipment equated to €4 million.

The price for one treatment by IDC isfixed in the contract (in fact the only figurewritten in the contract) and includes awhole set of services. The contract alsobound IDC to a number of obligationsincluding the core functions of establishingand managing the dialysis centres for theperiod of the contract duration; purchasingand installing new equipment; providingpatients with one meal during everytreatment; having complete responsibilityfor training local medical personnel; andguaranteeing to increase their salaries.Fulfilment of the terms of the contract isoverseen by the Ministry of Health, theInsurance Fund and the two host hospitals.



* When the tender was issued, RS had not yet passed legislation on public procurement.The tenders were simply held on the basis of ‘general practice’: advertisements werepublished in daily newspapers and a minimum of three acceptable bids were required foropening the evaluation procedure.

IDC Banja Luka and IDC Bijeljina becameoperational in April 2001 and May 2002providing services to 84 and 100 chronicpatients respectively. Both have expandedtheir operations; currently, IDC BanjaLuka provides services to more than 180patients and performs more than 2,500haemodialysis treatments per month;comparable figures for IDC Bijeljina are200 patients and 2,700 treatments permonth. The two centres now account formore than 50% of all RS’s dialysis patients.The increase in the number of patientstreated is primarily due to the decreasedmortality rate of dialysis patients. Qualityassurance is carried out by annual patientsurveys conducted according to ISOstandard 9001:2000.

One unforeseen challenge that the centresmust face was the introduction of valueadded tax (VAT) from 2006. While healthcare service delivery is exempt from thistax, the dialysis centres must pay 17%VAT on all equipment purchased. This isproblematic as the centres now have todeal with an inevitable increase in expen-diture, without any possibility of beingable to pass this increase on to patients,since the activity price is already fixed inthe contract. A regulation that wouldwaive health care service providers fromVAT on all equipment is being discussed.

Initially, IDC Banja Luka and Bijeljinacontracts were awarded for seven and nineyears respectively. The Ministries ofHealth and Social Welfare and ForeignEconomic Affairs will now sign newcontracts with both centres for an addi-tional fifteen years. Based on these positiveexperiences, the National HealthInsurance Fund has issued PPP guidelines*as a foundation for future privatisations,with the ultimate goal of privatising 80%of all state dialysis centres.

The success of the pilot has also triggeredinterest in using this model in other areassuch as radiotherapy and radiology. Thegovernment is now looking at ways toattract other international investors and topromote more competition in the privatedelivery of health care services. Neigh-bouring countries have also requestedmore ‘how-to’ information, expressingtheir interest in learning from this type ofPPP, in an attempt to make their post-

conflict health care systems more costeffective and of higher quality.

Hospital catering in Tirana, AlbaniaIn 1996, a survey of the 1,450-bed MotherTheresa University hospital in Tirana indi-cated that patients were very dissatisfiedwith the food served, such that 80% wasrefused. All food was being prepared inone central kitchen and then distributed tothe six different hospital buildings. Thekitchen and its equipment were in a poorstate; moreover electricity and runningwater were not always available.Frequently food intended for patientsactually ended up in the hands of hospitalemployees and their families.

Considering these challenges, the hospitaladministration decided to outsourcecatering services to a specialist company.An assessment of needs was conducted, thecost of the service calculated and the docu-ments for the tender prepared.

The contract was subsequently awardedto an Italian firm for approximatelyUS$66,000. This value is adjusted twice ayear to take account of official inflationrates reported by the National StatisticalInstitute. Approved by the Minister ofHealth, the ten-page contract requires thedelivery of 1,125 meals a day, stipulatesdifferent diets for different illnesses and isnot a concession contract. The successfulbidder is also responsible for theconstruction of a new fully equippedcentral kitchen, as well as training for themuch reduced work force of 25 employees(compared with 69 under the old system).Under the terms of the contract, theprivate contractor directly employs thecatering staff. It is also responsible forpurchasing foodstuffs, general expensesand maintenance costs. The menu mustalso be approved by a doctor.

The Italian company has investedUS$700,000 in building and furnishing thenew kitchen, upgrading the electrical andheating systems, improving deliveryservices and staff training. In turn, thehospital provides space within its premisesand makes a fixed monthly payment. Theservice is controlled by a support serviceunit within the University HospitalCentre.

Both the quality of the food and patient

satisfaction levels have increased. Oneproblem that still remains however lieswith the distribution system. Although thefood is prepared by the Italian company’sstaff, it has continued to be distributed byhospital employees and unfortunatelyfood often still does not reach the patient.This situation will be taken into consider-ation when drafting new contracts, so as toguarantee that all companies have an obli-gation to directly deliver meals to patients.

Conclusion – the future of PPPThese case studies from three countries inthe World Bank’s Eastern Europe regionindicate that factors for successful public-private collaboration include support fromkey stakeholders including government,patients and health care professionals; thissupport can be built through informationand communication campaigns.

It is also important to have appropriateenabling institutional, legal and regulatoryframeworks in place; sufficient measureswere already in place in the three countrieshighlighted here. Almost every model ofPPP or PPC can be created through acontract, provided the country has a soundlegal framework (civil code that includessophisticated contract law) in place and aconstitution that does not forbid theprivatisation of health care services.

It is also important before embarking onany PPP venture to undertake feasibilitystudies to ensure risk management andrisk-sharing mechanisms between theprivate and public partners are put in place.Control mechanisms to evaluate theperformance of these newly createdentities are also required.

Given that all these preconditions are putin place, a PPP can be a success for allstakeholders and help ease the financialpressures on any state’s health budget,provide high quality services for patients,and increase employee satisfaction throughtraining and higher salaries which may alsodissuade staff from seeking employmentelsewhere.

The author wishes to thank those whowere directly involved in these PPPprojects and assisted in research for thisarticle: Ruta Vainiene, former Advisor tothe Mayor of Vilnius, Lithuania; AferditaTafaj, Economic Director of the MotherTheresa University Hospital, Tirana,Albania and Marijan Bilic, Director ofthe International Dialysis Centre BanjaLuka, Republika Srpska, Bosnia andHerzegovina.



* The definition of PPP in RS according to the Health Insurance Fund guidelines for PPPin the health sector is: a cooperation between public/state institutions and private oper-ators whose aim is to finance, construct/reconstruct, provide management, maintaininfrastructure or provide services.



In January 2006, after years of gradualpreparatory steps, a new health insurancelaw was introduced in the Netherlands.1

One of the new elements is the possibilityof collective insurance. In the old system,collective contracts only existed in privateinsurance where employers could nego-tiate collective contracts for their privatelyinsured employees. In the new system,collective insurance is open to everyonewho is, or becomes a member of, acollective (whatever the basis of thecollective) that has a contract with aninsurance company. Any group of indi-viduals, whether united throughemployment, sports, patient interests oreven any other organisation formed solelyfor the purpose of obtaining collectiveinsurance, can enter into a contract with aninsurance company.

One of the reasons to include this possi-bility in the new insurance law was to givethe insured more of a voice in their

dealings with insurance companies. Byuniting in collectives, individuals, it wasthought, might be able to exert moreinfluence on the policies of insurancecompanies compared to those individuallyinsured. Insurance companies have anincentive to keep collectives satisfiedbecause of the threat of losing a collectivecontract and thus a large number ofinsured individuals.

The Netherlands is quite unique withrespect to the possibility of collectiveinsurance. Social health insurance systemsare employment based, or at least startedas employment-based systems.2 InGermany, company funds (Betrieb-skrankenkassen) can still be limited toemployees (and their dependents) of onespecific company. In contrast to Dutchemployer-based collectives, these companyfunds are separate risk pools. Privatehealth insurance in the United States is alsopredominantly employment based. Over60% of non-elderly Americans hademployment-based health plans in 2002.Most employment-based health plans areself-insured, i.e. the employer is financiallyresponsible for paying the health careclaims of its employees.3 However, theseexamples are different from the Dutchcollectives, whether employer based ornot. The Dutch system has nationalprospective risk adjustment and the risk

pool is formed by all the insured of oneinsurance company, irrespective of thetype of contract.

A brief outline of the insurance reform isgiven in Box 1. One of its aims is toimprove quality of care and secure afford-ability and long-term access to care bymeans of a system of regulated compe-tition. In the insurance market, insurerscompete to attract as many insurees aspossible, presumably by offering a goodbalance between premium level and servicequality. In the purchasing market, insurerswill presumably contract health careproviders with the best balance of priceand quality. However, purchasing activitiesare supposed to be steered by the prefer-ences of those being insured.

Since the implementation of the new lawin 2006, the number of individuals thathave taken out collective insurance hasbeen much larger than expected. This newemphasis on collective contracts sat wellwith the strategies of insurance companiesas it was consistent with their objective ofsecuring as large a share of the insurancemarket as possible. Although collectiveshave now become a major phenomenon onthe Dutch health insurance landscape, itremains to be seen whether they will beable to exert much influence on theinsurers.

Dutch health insurance reform:the new role of collectives

Peter P Groenewegen and Judith D de Jong

Summary: In the new Dutch health insurance system individuals have theoption of joining a collective insurance contract. Insurers are allowed to offerpremium reductions of up to 10% to members of collectives, based on thenumber of insurees. Collectives might exert more influence on insurers thanindividuals because of the threat of moving large numbers of the insured fromone insurer to another. Collectives have become an important feature in the newhealth insurance system as two-thirds of the Dutch population aged eighteen andover are now insured as part of a collective. Most collectives are employmentbased and specifically put more emphasis on premium levels than on service orquality of care compared to other collectives, such as patient organisations.

Key words: Health insurance, Reform, Premiums, Collective contracts, theNetherlands

Peter Groenewegen is Department Head,Netherlands Institute for Health ServicesResearch (NIVEL) and Professor of Socialand Geographical Aspects of Health andHealth Care at Utrecht University, theNetherlands. Judith de Jong is aResearcher at NIVEL and Head of theHealth Care Consumer Panel. Email: [email protected]

This article therefore focuses on the newposition of collectives in the Dutch healthinsurance system and focuses on high-lighting who is taking out collectiveinsurance and their characteristics andmotivations. It also highlights the originsof collectives, i.e. whether they are linkedto employment or some other basis; and todiscuss whether collective contractsactually increase the power of the insuredand in what direction. The informationused here is derived from regular surveysof participants of two large panels: theHealth Care Consumer Panel and theNational Panel of People with ChronicHealth Problems and Disabilities (bothrun by the Netherlands Institute forHealth Services Research, NIVEL), as wellas through a survey among collectives.5,6

Collective or individual insuranceCollective insurance is attractive topotential insurees because the law allowsinsurance companies to offer a reductionof up to 10% on the nominal premium(around €1,100 annually) for members ofa collective. The insurance law states that

the percentage of premium reduction mayonly be based on the size of the collectiveand not on other characteristics of thecollective or its members. Thus, collectivesof similar size should receive a similarpremium reduction. For complementaryinsurance, the size of premium reductionis not limited by law. Premium reductionsto date are on average 7%.7 However, thecheapest insurance premiums without anyreduction are still cheaper than the mostexpensive, even with a maximumreduction of 10%, as monthly premiumsfor the basic package for 2007 before anydiscount are at their cheapest €85,compared with €100 for the mostexpensive insurance schemes.8

It is also important to note that individualscannot be forced to join a collectiveinsurance contract. Thus, if an employernegotiates a collective contract, itsemployees have the choice of joining thiscollective contract, joining some othercollective contract (for example, through avoluntary organisation they are a memberof) or having an individual contract.

To insurance companies, collectivecontracts are attractive, at least in the initialyears of the new system, as they can helpattract as big a share of the insurancemarket as possible, even at the risk oflosing money on collective contracts.Collective contracts may have economicadvantages as a result of lower adminis-trative costs, when the collective guar-antees payment of the nominal premium.

Certainly they appear to have beenpopular. An unexpectedly high number ofindividuals are now insured via collectivecontracts; 55% of all those insured during2006, increasing to 63% in 2007.5 The like-lihood of being collectively insured ishigher for those of working age, men,those with a higher educational attainmentlevel, as well as those who perceive theirhealth as good.9 These differences are, tosome extent, related to the fact that thebiggest category of collectives are thoseorganised via employment.

Organisational basis of collectivesA wide range of organisations providecollective insurance; however, almostthree-quarters of those with collectiveinsurance are insured through theiremployer (Figure 1).The principal reasonsfor employers to offer their employees theoption of collective health insurance are tomaintain their reputations as goodemployers, as well as the incentives thatcollective insurance has in attracting andretaining employees. The dependents ofemployees can also be collectively insuredvia their employer.

Municipal social service departmentsusually have a collective contract for thosedependent on social welfare benefits.Collective contracts for these groups arealso attractive to insurance companies asthe nominal premiums are directly paid bysocial service departments. A smallnumber of individuals are also collectivelyinsured via patient organisations.6 Anotable example is the Diabetes Patients’Organisation (DVN), which has formu-lated its own terms of reference and subse-quently invited insurance companies tomake offers to the organisation.

The DVN is however one of the biggestpatient organisations in the Netherlandsand the risk adjustment system is such thatinsurance companies receive highercompensation from the central fund fordiabetics. For many of the smaller patientorganisations it is much more difficult tohave a collective contract, both as a resultof their size and because the risk



Box 1: The Dutch health insurance law

Abolition of distinction between private and public insurance.

Insurance under private law with public limiting conditions.

Obligation for every citizen to take out health insurance.

Obligation for insurance companies to accept every citizen without premium differentiation, risk selection or risk adjustment.

Free choice for citizens between insurance organisations (switching is possibleonce a year).

Premium level: nominal (typically around €1,100 per year) plus income relatedcontribution initially paid by employees and then subsequently reimbursed byemployers; overall half of the total costs of premiums will be from nominalpremiums and the remainder from income related contributions.

Compensation for low income individuals.

Basic package is identical for everybody, with a choice between schemes wherehealth care providers are directly paid by insurance companies and schemeswhere individuals initially pay the bills and then are reimbursed by theirinsurance companies.

Complementary insurance (not obligatory and not necessarily with same insureras basic package).

Choice of deductible (minimum €100, maximum €500).

No-claim premium reimbursement if annual health care costs less than €255.

Sources: Bartholomée Y, Maarse H, 2006,1 Ministry of Health, Welfare and Sports,2006.4

adjustment may be less preferential. ANIVEL survey showed that patient organ-isations have to put more effort into nego-tiating collective contracts thanemployers.6 It is therefore possible thatsmaller patient organisations, which areless professionally organised, do notalways have the means to negotiate acollective contract.

A new phenomenon is the special purpose

collective. Examples might include acollective of individuals who buy theirinsurance through a specific internet siteand thus automatically become part of acollective, or those who buy theirinsurance through a chain of retailchemists. In the case of insurancecompanies with the legal status of cooper-atives, by which members are not individ-ually liable for any deficits of the fund, theinsured are nonetheless formally members

and therefore could be defined as acollective. Even insurance companies withother legal status can establish an associ-ation of their insurees, so as to be able togive them a discount on the grounds ofbeing part of a collective. However, if allthose insured are receiving such a discount,one could ask whether this in fact really isa discount? Nevertheless, insurancecompanies might still be able to attractadditional insurees as a result of suchdiscounts.

Possible influence on insurancecompaniesOne of the aims of the new insurancesystem is that the insured exert influenceon insurance companies through the threatof switching insurers. This influenceshould lead to an optimal balance betweenthe nominal premium, services of theinsurance company, and the quality of carepurchased by the insurer.

The main reasons why individuals switchinsurer are the premium level and theirwish to join a collective contract withanother insurer. Collectives could also bein a better position to influence insurersbecause of their size. The question then isto what extent collectives choose aninsurance company on the basis of thepremium or of service and purchasingquality?

In general, younger and healthier peoplechoose more on the basis of the insurancepremium, while older and less healthypeople tend also to take into accountquality aspects of the insurer and the carethat they purchase.9 The NIVEL survey ofcollectives indicates that this is the samefor employment-based collectives,compared with other collectives (Table 1).

Patients’ collectives, in particular,emphasise service and quality aspects ofcollective contracts. In this way theycould, in theory, contribute to the goals ofinsurance reform. However, as Figure 1illustrated, they are quantitatively of minorimportance compared to employers’collectives.

The NIVEL survey also shows that patientorganisations are in a different positionfrom employment-based collectives, inthat they more often drive the initialprocess of contacting an insurer. Negotia-tions also take longer and premium reduc-tions tend to be smaller. One reason for thesmaller premium reductions might be thatthe percentage of members of patientorganisations that join the collective



Figure 1: Collective insurance by organisational basis, 20075

Table 1: Percentage of collectives that judged an aspect as (very) important in theirchoice of insurance company (19 employers’ collectives and 23 other collectives)

Aspect Employers Othercollectives

Premium Premium reduction for additional insurance 95% 83%

Premium reduction for basic insurance 89% 87%

Premium for additional insurance 89% 78%

Premium for basic insurance 84% 70%

Deductible and related premium reduction 21% 35%

Content of theinsurance

Coverage of additional insurance 89% 100%

Quality of contracted providers 79% 96%

Coverage for specific aids or drugs 63% 78%

Special care programmes 37% 65%

Quality of the insurancecompany

Service 84% 100%

Reputation 79% 78%

contract is lower than the percentage ofemployees that join the collective contractsobtained by their employers. However, ifthe premium reduction is related to thetype of collective and its members, differ-ences might develop in the costs of healthinsurance between different populationsub-groups. One implication might be thatpopulation sub-groups that generatehigher health care costs have less access tocollective contracts. Another question iswhether or not individuals would use thecollective if they were dissatisfied withtheir insurer? In one survey of the HealthCare Consumer Panel, 16% of the collec-tively insured indicated that they wouldturn to their collective in the event ofcomplaints.

ConclusionsApproximately two-thirds of the Dutchpopulation is now collectively insured;however, it is unclear whether or not thepercentage covered by collective contractswill continue to increase. Individualsmight be lured into collective contracts bythe headline reduction in premiumswithout looking too closely at absolutedifferences in premium cost. Furthermore,if the number of collectively insuredcontinues to grow, it may be questioned asto the basis of any premium reduction. Ifeverybody receives a premium reductionthen the premium without reduction issolely a virtual option .

For the overall aims of the insurance

reform to be achieved, the willingness ofindividuals to switch between insurers isimportant, if they are dissatisfied witheither price or quality. In practice however,it is only the young and healthy who arelikely to switch on grounds of price alone.Switching for other population groupsmay be more difficult. The newly estab-lished Dutch Health Care Authority(NZa) which monitors the healthinsurance market does however have theauthority to intervene if it believes that theinterests of consumers are under threat.10

Nonetheless, for the time being, collectivesare not likely to have much impact on thepurchasing activities of insurancecompanies. They may however have moreimpact on their service orientation, partic-ularly if and when the collectively insuredcollectively voice their dissatisfaction overthe services of any insurance company.

REFERENCES

1. Bartholomée Y, Maarse H. Healthinsurance reform in the Netherlands. Eurohealth 2006;12(2):7–9.

2. Amelung V, Glied S, Topan A. Healthcare and the labor market: learning fromthe German experience. Journal of HealthPolitics, Policy and Law 2003;28:693–714.

3. Glied S, Borzi PC. The current state ofemployment-based health coverage. TheJournal of Law, Medicine and Ethics2004;32:404–9.

4. Ministry of Health, Welfare and Sports.

The New Care System in the Netherlands:Durability, Solidarity, Choice, Quality,Efficiency. The Hague: Ministry of Health,Welfare and Sports, 2006. Available at:http://www.minvws.nl/en/folders/z/2006/the-new-health-insurance-system-in-three-languages.asp.

5. NIVEL web site. Available atwww.nivel.nl/stelselwijziging

6. Van Ruth LM, De Jong JD, Groenewegen PP. De rol van collectiviteiten in het nieuwe zorgstelsel.[The Role of Collectives in the NewInsurance System]. Utrecht: NIVEL, 2007.

7. Vektis. Verzekerdenmobiliteit enkeuzegedrag. Hoe staat het ervoor in 2007?[The Mobility of the Insured and DecisionMaking. What is the Situation in 2007?]April 2007.

8. Kies Beter [Choose Better]. Available athttp://www.kiesbeter.nl/Zorgverzek-eringen

9. De Jong JD, Groenewegen PP. Wisselenvan zorgverzekeraar in het nieuwe stelsel:een vergelijking van het zoek- enwisselgedrag van chronisch zieken engehandicapten met dat van de algemenebevolking. [Switching Health Insurer in theNew Insurance System: A Comparison ofSearch and Switch Behaviour of the Chron-ically Ill and Disabled and the GeneralPopulation] Utrecht: NIVEL, 2006.

10. Dutch Health Care Authority. Monitorzorgverzekeringsmarkt: de balans 2007.[Monitoring of the Health InsuranceMarket: The Balance 2007] Utrecht: NZa,2007.



Advanced Health Leadership Forum

First session: 6–13 January 2008University of California,Berkeley, San Francisco

Subsequent session: late June 2008England

http://ahlf.berkeley.edu

Email: Meg A [email protected]

Sample issue include:

• Leadership and evidence-based management workshops

• Effective policy implementation and strategies forhealth systems change

• How to assure quality

• Public vs. private health insurance mix

• Innovations in payer and health delivery connections

• Lessons learned from managed caretechniques/innovative budgeting techniques

• The use of risk adjustments for a variety of purposes

• Pharmaceutical innovation and regulation

• Defining benefit packages including explicit prioritysetting/ rationing

• Making use of the new consumerism

• ‘Information therapy’ prescriptions for consumers

• Technology changes and future health care predictions to prepare for

• Workshops on infectious disease preparedness andhealth care ethics

• IT and care management systems including a fieldtrip to Kaiser Permanente

A 14-day earned certificate programme fromthe University of California, Berkeley Schoolof Public Health in which renowned seniorfaculty and policy leaders from key international and national organisationsinteract with high-level participants re:evidenced-based solutions to key policy andmanagement issues. Participants grapple in apractical manner with the issues and optionsthat have been converging internationally.

Speakers include: Richard Feachem, FirstExecutive Director, Global Fund to FightAIDS, Tuberculosis and Malaria; Ian Morrison,well-known futurist; Leonard Schaeffer,Chairman of Wellpoint; high level officialsfrom Kaiser Permanente such as CEO GeorgeHalvorson, and expert faculty from UCBerkeley and UC San Francisco.

An innovative programme for senior health executives


PUBLIC HEALTH PERSPECTIVES

Medicine, Death, and DyingA historian of medicine and public health,I recently published Medicine and Care ofthe Dying. A Modern History.1 The mainaim of this study was to explore the rela-tionship between modern medicine’sapproach to the care of the dying and thechanging social, cultural, demographic,economic and political context over thelast two centuries or so in five ‘Anglo-Saxon’ countries: the United Kingdom, theUnited States, Australia, Canada and NewZealand.

Although the study takes this specificgeographical focus, I believe it is of interestto those involved in palliative care, as wellas health services generally, across Europe.Given ongoing media concern in Europe(as in other parts of the western world)about access to means of euthanasia, thechapter on the history of the euthanasiadebate, as well as that on the developmentof palliative care services and policy, willperhaps be of greatest interest to readers ofEurohealth.

The rise of modern scientific medicine hasbeen marked by a growing conflictbetween a medical-reductionist view ofhuman functioning and a deep and wide-spread cultural need in late-modern,

western society to find meaning in dyingand death. Furthermore, Americanphilosopher of medicine, Daniel Callahansees a struggle within medicine between aresearch imperative, with its ultimate goalof overcoming death itself, and a long-standing clinical imperative to treat deathas part of life and to make the process ofdying as humane and comfortable aspossible.

StructureThe first two chapters of the book providea broad background, ranging over the rela-tionships between medicine and religionand the internal development of scientificmedicine in the west since the sixteenthcentury. Medicine was deeply influencedby a Cartesian body-mind dualism that inpractice favoured the material and deper-sonalised the patient, while at the sametime the Christian view of death as a tran-sition to a superior, supernatural realitywas losing its meaning for an increasingnumber of people. Material success,earthly happiness, and collective masteryof the natural world were attracting moreand more adherents as the goals of thegood life.

In the course of the nineteenth century,experimental physiology, cell biology andbacteriology also provided medicine with ahitherto unprecedented reliable knowledgebase. Thus the modern hospital and thelaboratory became critically linked in theprocess of producing and applying thisnew scientific knowledge.

The subsequent chapter is more narrowlyconcerned with the history of medicine’sapproach to cancer and is something of acase study of the tensions betweenadvancing scientific knowledge for thelong-term attainment of cures comparedwith caring compassionately here and nowfor the terminal patient. Promoting thehumane care of patients dying, mainly ofcancer was, of course, the prime concernof the pioneers of modern hospice andpalliative care like United Kingdom’sCicely Saunders.

The book also includes a detailed accountof the ways in which this movementspread from the United Kingdom to other‘Anglo-Saxon’ countries, showing how theoriginal hospice idea was adapted to localorganisational and financial conditions.Recently, selected letters of Dr Saunders,covering the first forty years of themovement in the United Kingdom, havebeen published.2 The correspondenceprovides a fascinating, blow-by-blowaccount of the pioneering phase of thehospice and palliative care project.

It also shows that from an early date that ithad international dimensions. CicelySaunders frequently exchanged infor-mation on palliative care and relatedsubjects like euthanasia and care of AIDSpatients with health professionals andhospice enthusiasts in countries across theworld; from North America to Europe (forexample, Poland, West Germany, Franceand Italy) to Africa, Asia and Australasia.

Medicine, care of the dying,and care of the chronically ill

Milton Lewis

Summary: The palliative care movement began in Great Britain and spread quickly,not only to the United States, Australia, Canada, and New Zealand, but also tocontinental Europe. This article provides an overview of material covered in a newbook entitled ‘Medicine and Care of the Dying. A Modern History’. Historically,concern about palliative care has developed separately from that about better care forthe chronically ill. But the same demographic and other forces are now shaping thecontext in which more patient-centred services are needed. Palliative care and carefor the chronically ill should be better integrated, as should health services generally.

Keywords : History, Care of Chronically Ill, Palliative Care, Dying

Milton Lewis is Honorary SeniorResearch Fellow, Australian Health PolicyInstitute, University of Sydney, Sydney,New South Wales, 2006, Australia. Email: [email protected]

Of the remaining three chapters in thebook, one relates the history of paincontrol. Clearly, effective painmanagement has been and remains the sinequa non of successful palliative care.Another chapter discusses the history ofeuthanasia from classical to contemporarytimes, although the emphasis is on theperiod from the late nineteenth centurywhen this discussion ceased to be confinedto philosophical circles and later becamethe subject of serious public policy debate.

The final chapter brings together observa-tions and conclusions, especially aboutmedicine’s heritage of materialism, reduc-tionism and the cultural roots of caring inlate-modern, ‘secular’ societies. From thelate 1980s, the spread of palliative careacross Europe was rapid. When theEuropean Association for Palliative Carewas set up at the close of 1988, there were42 members from nine European coun-tries. In less than a decade this had grownto 8,481 members from 29 European coun-tries (plus 141 individual members from 27countries outside Europe).3

Resonance in EuropeWhile this book is concerned to a largeextent with developments in NorthAmerica and Australasia, most if not all,the leading issues raised will have strongresonance in Europe. Certainly, this is thecase with philosophical issues concerningthe nature of modern medicine, the corevalues of palliative care, or debates aboutthe legalisation of euthanasia. Even, forexample, when considering the importantissue of the organisation of palliative careservices, the history of adaptation of theBritish hospice archetype is similar to thatin other European countries. So thematerial in the book, in this respect, willprovide European readers with more in-depth information about experiments inorganisational forms in different butrelevant health systems in comparableeconomically advanced countries.

Diversity of service form was, of course,the case in Europe itself virtually from theoutset. The United Kingdom pioneeredthe process with inpatient hospice carefrom 1967. Sweden introduced hospital-based home care in 1977, Italy a home careprogramme in 1980, Germany hospitalinpatient care in 1983, Spain a palliativecare unit within a hospital medicaloncology department in 1984, Belgium apalliative care unit and a home care servicein 1985 and the Netherlands inpatienthospice care in 1991. Interest in hospices

emerged as early as the 1970s in Poland,but only after the fall of communism wereservices systematically developed in centraland eastern Europe in the 1990s.4,5

Towards integration of palliative careand care of the chronically illHistorically, concern about palliative caredeveloped separately from that aboutserious, chronic illness management, butthey are both in fact quintessentiallypatient-centred responses to the samecontemporary epidemiological, demo-graphic, social and economic forces,requiring basic changes in health systemorganisation and medical practice. Acrossthe economically advanced world, healthservices managers, researchers, cliniciansand policymakers are now focussed on theneed for better quality, integrated care forchronic disease sufferers and on the more

general issue of restructuring health caresystems. This restructuring has theobjective of moving systems away fromtheir historical orientation to hospitalsdevoted to medical specialities and acutecare, towards more community and home-based care for people, especially olderpeople, with serious, chronic conditions.

The next logical step is to better coordinatepalliative care and chronic illness care. The‘Bridges to Health’ model recentlydeveloped for application in the UnitedStates health system in response to theInstitute of Medicine’s six goals for care ingeneral (safety, effectiveness, efficiency,patient-centeredness, timeliness, andequity), is one interesting conceptualapproach to this task, as well as the largertask of health care system restructuring .6*

Focussed on the interests of patients,



Table 1 The 'Bridges to Health' model

Population characteristics

Priority concerns Major health care components

Health care goals

Healthy Longevity by preventingaccidents, illness and earlystage illness progression

Doctors’ offices, healthclinics and publicly availablehealth information

Staying healthy

Maternal and infant health

Healthy babies, lowmaternal risk, fertilitycontrol

Perinatal services, deliveryand perinatal care; fertilitycontrol/ enhancement

Staying healthy

Acutely ill, withlikely return tohealth

Return to healthy state withminimal suffering

Emergency services,hospitals, doctors’ offices,medications or short termrehabilitation

Getting well

Chronic conditions,with generally‘normal function’

Longevity, limiting diseaseprogression, accommo-dating environment

Self-management, doctors’offices, hospitalisations,accident and emergencyvisits

Living with illnessor disability

Significant butstable disability(including mentaldisability)

Autonomy, rehabilitation,limiting progression,accommodating envi-ronment, caregiver support

Home-based services, environmental adaptation,rehabilitation and institutional services

Living with illnessor disability

“Dying” with shortdecline

Comfort, dignity, lifeclosure, caregiver support,planning ahead

At-home services, hospiceand personal care services

Coping with illnessat the end of life

Limited reserve and serious exacerbations

Avoiding exacerbations,maintaining function andspecific guidance planning

Self-care support, at-homeservices, 24/7 on-call access to medical guidanceand home-based care


Long course ofdecline fromdementia and/orfrailty

Support for caregivers,maintaining function, skinintegrity, mobility andspecific advance planning

Home-based services,mobility and care devices,family caregiver training andsupport and nursing facilities


rather than those of individual or institu-tional providers, the proponents of themodel divide the whole population intoeight groups: those in good health; in‘maternal/infant situations’; those withacute illness; living with stable chronicconditions; with serious but stabledisability; with failing health near death;with advanced organ system failure; andwith long-term frailty. Each group has itsown service priorities, as well as definitionsof optimal health, and the modelencourages us to think how programmesfor groups that meet the universal need forintegrated care might be promoted, asspecified in Table 1.6

Many health professionals, and indeed

citizens in general, have become used toconceiving of the health care system in theold fragmented way.7 The ‘bridges tohealth’ model offers new conceptual clarityand helps launch us on the journey to amore integrated system of health care. Thispromises to improve quality of care for thechronically ill and the dying as well asother population groups.

REFERENCES

1. Lewis MJ. Medicine and Care of theDying. A Modern History. OxfordUniversity Press: New York, 2007

2. Clark D (ed). Cicely Saunders. Founderof the Hospice Movement. Selected Letters

1959–1999. Oxford University Press:Oxford, 2005.

3. Speck P. Palliative care organisationswith a global perspective. PalliativeMedicine 1999;13:70.

4. Hardy A, Tansey EM. Medical enterprise and global response,1945–2000. In: Bynum WF, Hardy A,Jacyna S, Lawrence C, Tansey EM (eds).The Western Medical Tradition 1800 to2000. Cambridge University Press:Cambridge, 2006, p. 446.

5. Wright M, Clark D. The developmentof palliative care in Poznan, Poland.European Journal of Palliative Care2003;10(1):26.

6. Lynn J, Straube BM, Bell KM, Jencks SF, Kambic RT. Using population segmen-tation to provide better health care for all: the ‘Bridges to Health’ model. MilbankQuarterly 2007;85(2):185–208.

7. Schoenbaum SC, Gauthier AK, KorenMJ. Commentary on the ‘Bridges toHealth’ model. Milbank Quarterly2007:85(2):209–11.

A generation ago, when a WHO-ledglobal programme had just succeeded ineradicating smallpox, many public healthexperts believed we were at the dawn of a

new era. All the major scourges wouldsoon be eliminated, and epidemics wouldbe consigned to the history books. Unfor-tunately, the emergence of HIV/AIDS inthe 1980s and SARS (Severe Acute Respi-ratory Syndrome) in 2003 shattered thisillusion. We are now painfully aware thatnew communicable diseases can appear

without warning, and that ‘old’ diseasescan re-emerge, sometimes in new drugresistant strains. Furthermore, SARS high-lighted the speed with which a communi-cable disease can spread internationally inthe age of globalisation. This interconnect-edness of public health in Europe andinternationally, was one of the main



* Earlier, Joanne Lynn explored the implications for organisation of palliative care of thedifferent ‘illness trajectories’ of serious chronic conditions in the last phase of life: for ashort period of evident decline (mostly cancer); for chronic illness with intermittent exac-erbations and sudden dying (mostly organ system failure); and for slow dwindling (mostlyfrailty and dementia). See Lynn J. Sick to Death and Not Going to Take it Anymore!Reforming Health Care for the Last Years of Life. University of California Press: Berkeley,2004.

ECDC: Tackling the freemovement of microbes

Zsuzsanna Jakab

Summary: Now entering its third year, the European Centre for Disease Prevention and Control(ECDC) is showing the value of having an expert agency to support EU Institutions and MemberStates in meeting the challenge of managing communicable diseases in an interconnected world:strengthening EU preparedness and response to disease outbreaks and consolidating EU leveldisease surveillance. The Centre produces scientific advice and risk assessments on a wide range ofissues; communicating the results of its activities via Eurosurveillance (an independent scientificjournal), as well as using new technologies such as webcasting. ECDC’s first ever Annual Epidemi-ological Report, published in June 2007, analyses ten years of surveillance data from across the EUand identifies a number of key public health challenges posed by communicable diseases. ECDC’sMulti-Annual Strategy for 2007–2013 focuses on how the Centre can help address these challenges.

Key words: EU Health Policy, ECDC, Communicable Diseases, Surveillance, Epidemiology

Zsuzsanna Jakab is Director, EuropeanCentre for Disease Prevention andControl (ECDC), Stockholm.

reasons why the European Union estab-lished a European Centre for DiseasePrevention and Control (ECDC).

Why ECDC was createdIncreasing the interconnectedness of itsMember States’ economies and societies isa central objective of the European Union.The Union is built on four freedoms: thefree movement of goods, persons, servicesand capital. However, as people, farmanimals and food cross borders they willinevitably, on occasion, take unwantedmicrobes with them. This ‘free movementof microbes’ means that public healthdevelopments in one EU country can be ofimmediate concern to its Europeanpartners. For example, big hotels in majorEU cities typically have guests from acrossthe EU, so a disease outbreak centred onsuch a hotel can have implications fornumerous Member States. Food producersin the EU typically sell to clients across theEU, so investigating food borne outbreakscan also require cross border investigation.

EU cooperation on the surveillance ofcommunicable disease started in the 1980swith the EuroHIV network and expandedduring the 1990s. By 2004 there were somesixteen EU funded networks carrying outdisease surveillance and linking diseaseexperts. Since the late 1990s Member Stateshave also been exchanging information ondisease outbreaks with the potential tospread across borders, via the EU’s EarlyWarning and Response System (EWRS) onpublic health threats.

ECDC was created to consolidate andfurther develop this cooperation. Surveil-lance networks had been funded on aproject by project basis, often focusing onjust one or a small group of diseases.ECDC’s mission was to develop a longterm surveillance strategy and consolidateexisting activities. ECDC was to assist theEuropean Commission in running theEWRS and offer a pool of expertise andresources to help respond to incidents. TheCentre was also given the role of expertadvisor to the EU Institutions andMember States on communicable diseaseissues.

What has been achievedEnabling legislation to create ECDC waspassed by the European Parliament andCouncil1 in the spring of 2004. TheCentre’s first Director, Zsuzsanna Jakab,who was formerly the State Secretary atthe Ministry of Health in Hungary, wasappointed at the end of 2004 and took up

her post on 1 March 2005. By May 2005 acore staff was in place and ECDC becameoperational.

Although still a young organisation,ECDC has become a key partner for EUand EEA/EFTA countries in the fightagainst infectious diseases. The Centreplayed a significant role in the EU’sresponse to the arrival of H5N1 avianinfluenza in the EU neighbourhood in theautumn of 2005, providing an overallassessment of the public health risk asso-ciated with this development, scientificguidance on the protection of peopleexposed to infected birds and participatingin international missions to affected coun-tries. Working closely with the EuropeanCommission and WHO Europe, ECDCdeveloped a methodology to help coun-tries assess their preparedness against apossible influenza pandemic. By the end ofthis year ECDC officials will haveconducted preparedness assessment visitsto all of the EU and EEA/EFTA MemberStates.

ECDC is also developing input to theEuropean Commission on actions toaddress the continuing challenge of tuber-culosis in the EU and held a scientificseminar on tuberculosis in March 2007.2 Ithas also led an expert group to investigatethe emergence of drug resistant strains ofClostridium difficile in EU countries andestablished a network of national focalpoints on antimicrobial resistance issues.

ECDC’s disease-specific activities arecarried out within seven horizontalprojects which cover the range of 49communicable diseases that are notifiableat EU level.* The Centre has expandedfrom 40 staff at the end of 2005 to nearly200 staff by the end of 2007. Though muchsmaller than its US namesake, and consid-erably smaller than the public health institutes of France, Germany and the UK,it can still make a sizeable scientific contribution.

Improving EU level disease surveillanceAs already mentioned, a core task forECDC is the consolidation and devel-opment of a Europe wide surveillancesystem that provides high quality, compa-rable and easy to access information on allinfectious diseases of interest at EU level.By 2005, when the Centre became opera-tional, each of the sixteen Designated

Surveillance Networks had their own data-bases and systems of reporting. With agrowing number of networks, the need forcoordination and a standardised approachto data collection became urgent. Toaddress this need, ECDC has beenconducting an external evaluation andassessment of the existing EU wide surveil-lance networks.

Already in 2007, Member States will reporttheir data to a single EU level surveillancedatabase hosted by ECDC (TESSy – TheEuropean Surveillance System). This taskincludes managing the delicate transfer oftheir various existing surveillance data-bases to ECDC. A number of benefitsarise from this approach, in particular thestandardisation of procedures, databasesand outputs. This in turn allows for thetackling of infectious disease surveillancein a synergistic way, in order to betterunderstand and control the threat posedby infectious diseases. In addition, ECDC will also be responsible for themaintenance of networks of referencelaboratories.

Vigilant to the emergence of healththreatsECDC is tasked with reinforcing anddeveloping Europe’s rapid alert systemsagainst disease outbreaks. The Centre isconstantly monitoring health threatsacross the EU and, as intended, is takingover the responsibility of hosting theinformation technology system thatsupports the Early Warning and ResponseSystem.

ECDC’s early warning and response activities are based on three main sets offunctions: a ‘round the clock’ availabilityof specialists in communicable diseases, adaily briefing where all active threats arediscussed and decisions are made aboutepidemic intelligence processes and ECDCactions to be taken, as well as a database tostore, process and report potential healththreats (the Threat Tracking Tool – TTT).

Furthermore, a state of the art EmergencyOperations Centre (EOC) has been set upat ECDC’s premises, in order to ensureoptimal communication and coordinationmechanisms for risk assessment with allMember States. It is used on a daily basisfor standard epidemic intelligence activ-ities, but allows for rapid and efficientresponse and communication should a



* 46 diseases are specified in Commission Decision 2003/542/EC, plus West Nile Virus, SARSand human cases of H5N1 avian influenza which are also notifiable.



major international public health eventoccur. In addition, ECDC can assist coun-tries by mobilising Outbreak AssistanceTeams and contributing experts to interna-tional teams if needed.

Technical and scientific adviceAnother core task of ECDC is to providesound and independent technical andscientific advice. For this the Centre bringstogether technical expertise in specificfields through its various EU widenetworks and ad hoc scientific panels.These panels have been set up in order toanswer specific questions forwarded to theCentre by the European Commission andMember States. Two scientific panels havealready produced scientific advice, one onavian influenza and the other on seasonalinfluenza vaccine and pneumococcalvaccine. Their work has been published astechnical reports. Currently, scientificpanels are addressing questions regardingthe human papilloma virus (HPV) vaccineand influenza H5N1 human vaccine.

As already mentioned, ECDC has beenworking with the European Commissionand the WHO Regional Office in Europeto assess national pandemic preparednessplans through country visits and by organ-ising regional workshops. It has alreadyproduced a report with a first preparednessreview of 27 countries (25 EU memberstates plus Iceland and Norway),3 with asecond status report to be released aftercompleting the assessment of all EU coun-tries. This report is the first formal docu-mentation of the EU’s pandemicpreparedness status; it describes progressmade and highlights areas where furtherimprovements are needed.

Communicating on ECDC’s activitiesThe Centre has a mandate to communicateboth to stakeholders and the general publicabout its activities. Reports and guidelinesare made available on ECDC’s website andthe media is kept updated on the Centre’smajor activities through press releases,press conferences and webcasts.4

Currently the Centre has an interimwebsite which is being continuouslyimproved until a fully fledged webportal isin place in 2009. Information addressed tothe general public will be offered in all EUofficial languages, while informationtargeted at experts and public health officials will be published in English only.

The leading open access European scien-tific journal devoted to communicablediseases, Eurosurveillance, became the

independent scientific in-house journal ofECDC. Following ten years successfulcollaboration between the lnstitut de VeilleSanitaire in Paris, France and the HealthProtection Agency in London, UnitedKingdom and under the auspices of theEuropean Commission, the ECDC tookover the funding and publication of thisjournal in March 2007. Eurosurveillance isavailable in three separate formats: weeklyand monthly online releases and a quar-terly print compilation.5

The EU’s main challenges in infectiousdiseasesThe Centre launched, in June 2007, its firstever Annual Epidemiological Report, akey publication that for the first timeoffers an overview of the situation inrespect of communicable diseases in 25 EUcountries and Iceland and Norway. It alsoexamines the social and demographiccontexts over the last decade, in order tomake action proposals for decision makersto strengthen prevention, control andsurveillance in Europe.

The report shows that the incidence ofmost of the 49 diseases analysed by ECDChas either declined or remained stable overthe past ten years, which confirms thatpublic health systems in the EU aregenerally good at fighting infectiousdiseases. But this should not lead tocomplacency, as some negative trends wereidentified. The fact that new infectiousdiseases can emerge without warning, andexisting viruses and bacteria can adapt ormutate, should also not be underestimated.

This report also gives a clear picture of themajor health threats faced by Europe in thearea of infectious diseases, which alsorepresent the areas identified by ECDC aspriorities in its work plan. These includethe growing problem of antimicrobialresistance and healthcare associated infec-tions, as well as the rising rates ofHIV/AIDS; with an estimated 30% ofHIV positive individuals in the EU beingunaware of their infection. Another threatis tuberculosis, which is rising amongvulnerable groups such as migrants, andalso where cases of drug resistant tubercu-losis are being seen across the EU, partic-ularly in the Baltic States.

Not to be dismissed is the ongoing threatposed by seasonal influenza, which eachwinter causes hundreds of thousands ofpeople in the EU to become seriously ill.ECDC’s epidemiological report showstwo further diseases with very high incidence numbers, namely Chlamydia

infection and campylobacteriosis. Eventhough they do not cause such seriousdisease as the priority diseases mentionedabove, the high number of cases alreadyrepresents a huge challenge.

The future of ECDCIn June 2007 ECDC’s Management Boardendorsed the key principles of a long termstrategy to develop the Centre’s activitiesand help address the key challenges iden-tified in it’s Annual EpidemiologicalReport. There is a long term and ambitiousagenda for ECDC to work on in the areaof communicable diseases. Equallythough, it is possible that the Centre’smandate could be expanded to includesome other public health issues.

This autumn, following a public tender,ECDC will appoint an independentconsultant to conduct an evaluation of theCentre’s activities. The results of this eval-uation will be given to the Centre’sManagement Board, who in turn will makerecommendations to the EuropeanCommission. Based on the results of theevaluation and the recommendations ofthe Management Board, the EuropeanCommission will decide, probablytowards the end of 2008, whether theECDC’s Founding Regulation needs to beamended.

REFERENCES

1. Commission of the European Communities. Regulation (EC) No851/2004 of the European Parliament andof the Council of 21 April 2004 establishinga European Centre for Disease Preventionand Control. Brussels: Commission of theEuropean Communities, OJ L 142, 30April 2004.

2. ECDC. ECDC Scientific Seminar onTuberculosis. Brussels, EuropeanParliament, 22 March 2007. Available athttp://ecdc.europa.eu/tbseminar

3. ECDC. Pandemic InfluenzaPreparedness in the EU. Stockholm:ECDC, 2007. Available at:http://ecdc.europa.eu/pdf/Pandemie_preparedness.pdf.

4. ECDC webcasts can be viewed athttp://ecdc.europa.eu/webcast

5. For more information about Eurosur-veillance see: http://www.eurosurveil-lance.org

From the mid-1990s, Bulgaria has beenundergoing significant economic, politicaland social change arising from the chal-lenges of transition and the structuralmeasures needed to achieve EU accessionin January 2007. Health system reforms, asan integral part of economic and socialreforms, have aimed to make the Bulgarianhealth system more efficient andresponsive to patients’ needs by improvingboth the delivery and quality of services.

Specific mechanisms were expected topromote better quality health services andprovide solutions to a range of challenges,including: competition between providersfor contracts with the National HealthInsurance Fund (NHIF); inclusion ofquality control mechanisms in thesecontracts; and increased choice forBulgarians, in terms of both serviceproviders and voluntary health insuranceplans.

Legal and structural improvements tofacilitate better qualityThe quality of medical services in Bulgariais now monitored by the Ministry ofHealth, NHIF, the Bulgarian MedicalAssociation and the Union of Dentists.Standards for different medical specialitieswere laid out in the 2004 Health Act.1 Thisalso outlined the responsibilities of the 28regional health centres and the Ministry ofHealth in controlling the competencies ofmedical specialists and monitoring thequality of care.

In 2003, hospital accreditation, undertakenby an Accreditation Council at theMinistry of Health, was introduced; now

some hospitals have the InternationalOrganisation for Standardisation (ISO)certificate. However, these initiatives haveneither been very successful, nor wellreceived, due to a lack of incentives toreward such high quality care, as well asthe poor links between the accreditationprocess and any difference in paymentsreceived from the NHIF.

Amendments to the Act on ProfessionalOrganisations of Physicians and Dentistsin 19982 imposed an obligation on theseprofessional associations to establish rulesfor good medical practice for theirrespective members. As a result, theconcepts of life-long learning andcontinuing education have been acceptedand viewed as a component of any qualityassurance system.

Patient empowerment is a new andimportant approach to improving thequality of health services in the country.Different methods are used to give patientsa greater say over their medical care, suchas in choice of provider and improvedaccess to information. A process forpatient complaints and appeals is alsoenshrined in both the 2004 Health Act1

and the Act on the Professional Organisa-tions of Physicians and Dentists.2

The 1998 Health Insurance Act3 and theNational Framework Contract4 alsooutline the individual’s right to choosegeneral practitioner, without adminis-trative or geographical constraints. Indi-viduals can also choose in which hospitalto be treated, although most will still beassigned a specific consultant within thishospital. Since 2005, some patient groupshave been able to choose their ownspecialist without general practitioner(GP) referral, as in the case of mothers inrespect of paediatricians and gynaecolo-gists. Considerable progress has also beenmade through the transition from a pater-nalistic to a more autonomous approach todecision making. Now patients are

informed about the relative risks andbenefits of treatment alternatives and canparticipate in making final decisions oncourses of action to adopt.

Contracting to enhance the quality ofhealth servicesEnhancing the quality of health serviceswas one key reason for the introduction ofcontracting reforms. This shift tocontracting between the NHIF and healthproviders was accompanied by a moveaway from historical or norm-based budg-eting to performance related payments.

Quality control mechanisms in contractsbetween providers and the NHIF obligeproviders to participate in a comprehensivequality assurance system. Contracts nowspecify the process of service delivery, aswell as the medical standards and guide-lines to be followed by providers; all ofwhich are expected to lead to qualityimprovements.

Both public and private sector providerscan enter into contracts with the NHIF todeliver services. The NHIF specifies therequirements that providers must meet inorder to be eligible to participate in theprovider selection process; an initialquality assurance measure in theoryexcludes those providers that do not meetminimum structural quality requirements.However, these measures of selectivecontracting are not applied fully inpractice, thus the potential to facilitatequality improvements has not been fullyrealised.

Methods of provider payments andincentives to achieve better qualityNew methods of paying providers wereintended to increase efficiency and ensurethe high quality of services. Case-basedpayments (clinical pathways) for publicand private inpatient providers were intro-duced in 2001. Although there are discus-sions regarding the efficiency of NHIF


EUROPEAN SNAPSHOTS

Promoting the quality ofhealth services in Bulgaria

Olga Avdeeva and Lidia Georgieva

Olga Adeeva was until August 2007Research and Development Officer at theEuropean Observatory on Health Systemsand Policies, Berlin Hub, Germany. LidiaGeorgieva is Head of Health RiskManagement, MARSH Bulgaria.

payments, in particular these are thoughtto have improved the continuity and coor-dination of care across different disciplinesand sectors, as well supporting clinicaleffectiveness and clinical audit.

In Bulgaria, inpatient public sector healthpersonnel are, in the main, salaried;however, the incentives of additionalperformance-related bonuses have since2002 been included in provider contractswith the NHIF. These bonuses link thepromotion of quality to the reim-bursement process.

The question of how to provide incentivesto achieve high quality in primary careremains an open issue. The establishmentof independent (private) practices forprimary care physicians and the creation ofa system of general practitioners (GPs) wasone of the most successful steps in thereform process. This reform changed theenvironment in which GPs now operate,from a system of salaried physicians into asystem based on capitation, adjusted forage and gender, with the payment ofbonuses dependent on the evaluation ofactivity indicators and quality parameters.Higher levels of remuneration have alsobeen made available to those working insparsely populated and/or harsh remoteregions, as well as for the provision of so-called ‘socially important’ services, such aspreventative services and child immuni-sation. Introducing this capitationpayment mechanism into the reim-bursement system also has given GPs anincentive to invest in improvements in thequality of their services, in order to attractpatients who now are ‘shopping around’for the best primary care services.

Improving quality by generating competitionPrivatisation was seen as the mostpowerful tool in Bulgaria to increase bothquality and competitiveness. Competitionbetween GPs encouraged by this privati-sation process might, it was thought, forceless productive GPs out of business.However, this potential for productivityimprovement has been limited, due to thelack of competition between providers insome rural areas, as well as the continuedexistence of incentives for cream skimmingand supplier induced demand.

Private practice was legalised in 1991 andhas expanded significantly: private outpa-tient facilities now account for about 30%of all medical centres, 95% of allspecialised individual and group practicesand 16% of all hospitals.5 In 1992, themunicipalities were also given ownershipof most health care facilities. Following thelegal framework of the Health Establish-ments Act,6 state and municipality-ownedfacilities were transformed into privatestate and municipality-owned enterprises.By making use of the economic instru-ments of competition and private property,it was hoped to set in motion a process thatwould result in better quality services andmore successful management of health carefacilities’ resources. Despite this, theprivate market has remained limited, sinceproviders that do not have contracts withthe NHIF must rely on out-of-pocketpayments by patients.

Voluntary health insurance (VHI) inBulgaria now supplements coverage of thestate’s basic benefit package by offeringvariety in providers, waiting times, quality

and other amenities that are oftenotherwise paid for out-of-pocket. Yet, themarket for voluntary health insuranceremains limited due to financial barriers toaccess that most individuals must contendwith. So far it has not contributed signifi-cantly to quality improvements in healthservices for the general population, exceptfor those services provided by healthprofessionals reimbursed by both thepublic and private sectors who are thusable to treat public and private (includingVHI funded) patients differently.

The mixture of approaches implemented inBulgaria, with the goal of promoting thequality of health care services, has bothadvantages and limitations. Regardless, itcan be viewed as a substantial undertaking,that has been complemented by changes inthe organisation and financing of healthcare, coupled with a commitment to efficiency and the needs of patients.

REFERENCES

1. Health Act 2004. State Gazette 2004;88(06.11 with amendments).

2. Act on the Professional Organisations ofPhysicians and Dentists 1998. OfficialGazette 1998;83.

3. Health Insurance Act, 1998. StateGazette 1998;70.

4. National Framework Contract. StateGazette 2000; 42 (with amendments).

5. National Centre of Health Informatics.Public Health Statistics. Sofia: NCHI,2005.

6. Health Establishments Act, 1999. StateGazette 1999;88 (with amendments).


EUROPEAN SNAPSHOTS

International trends highlight the confluence ofeconomics, politics and legal considerations inthe health policy process. HEPL serves as aforum for scholarship on health policy issuesfrom these perspectives, and is of use toacademics, policy makers and health caremanagers and professionals.

HEPL is international in scope, and publishesboth theoretical and applied work. Considerable

emphasis is placed on rigorous conceptual development and analysis, and onthe presentation of empirical evidence that is relevant to the policy process.

The most important output of HEPL are original research articles, althoughreaders are also encouraged to propose subjects for editorials, reviewarticles and debate essays.

HEPL invites high quality contributions in healtheconomics, political science and/or law, withinits general aims and scope. Articles on socialcare issues are also considered. The recom-mended text-length of articles is 6–8,000 wordsfor original research articles, 2,000 words forguest editorials, 5,000 words for review articles,and 3,000 words for debate essays.

Instructions for contributors can be found atwww.cambridge.org/journals/hep/ifc

All contributions and correspondence shouldbe sent to: Anna Maresso, Managing Editor, LSE Health, London School of Economics andPolitical Science, Houghton Street, LondonWC2A 2AE, UK. Email [email protected]

Health Economics, Policy and Law

Sometimes patients schedule annual visitsto health professionals even if they donot have any symptoms, because clini-cians might discover something withtheir specialised knowledge and tech-nologies that enable ‘early detection’ ofillness. Doctors and advocacy organisa-tions often encourage this screening ofhealthy people, in the belief it is goodpractice.

Unfortunately, many widely used testsare not very accurate, or they find conditions for which there is no effectivetreatment. At their worst, they leavepatients worse off than they were before.

No clear answersEvidence-based guidelines suggest thatinstead of an annual health check-up, forwhich there is no evidence, doctorsshould tailor screening to individualpatient health profiles and move to‘opportunistic’ screening – taking thetime to talk about prevention andscreening when patients come see themfor an acute problem.1–4

According to some researchers, doctorsshould also focus screening on peoplewho can benefit the most, providefollow-up treatment, and monitor theirpatients’ compliance with medical recom-mendations. Finally, they should screenonly for conditions that cause seriousillness or functional difficulties, and onlywhen an accurate test and effective treatments are available.5

Of course, no test is 100% accurate. If acondition is very rare in the populationbeing screened, the false-positive rate will

be high. Even with common conditions,prevalence will still be low enough tolead to many false positives. These falseresults cause stress and anguish forpatients who do not actually have thecondition.6,7 A test that provides a falsenegative result is also problematic, as itcan lead to complacency and a false senseof security – for example, a commonurine dipstick test to detect diabetescould fail to do so in four of every fivepatients who have the disease.6

Another problem with many screeningtests is ‘leadtime bias’ – the test coulddiscover a disease before the patient feelsill, but it does not actually extend thepatient’s life. This early detection canartificially inflate survival time bymoving up the diagnosis date, making thetest appear to be useful even thoughmortality does not in fact change.8,9

Exhibit A: The PSA testEarly detection is often an importantstrategy in the fight against cancer, partic-ularly with cancers that are aggressiveand must be found early to improve thepatient’s odds of survival. However, oneof the more widely used tests – to detectprostate cancer, a relatively slow-growingform of cancer – is quite problematic.

The prostate-specific antigen (PSA) testdoes not detect cancer itself – only abiopsy can do that – but rather levels of aprotein produced by the prostate glandwhich is associated with prostate cancer.The test leads to treatment for manycases of cancer that, if left alone, wouldnever become life-threatening.

Advocates often claim that since the PSAtest was introduced, deaths from prostatecancer have dropped, but mortality ratesstarted falling well before the PSA testcould have had an effect.10–12 The test isnot recommended for widespreadscreening of men without symptoms,

Mythbusters


Myth: Early detection is good for everyone

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 2006. © CHSRF, 2006.


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

largely because of its high false-positiverate. Patients receiving a false-positiveresult can suffer anxiety, and they couldhave to undergo painful and unnecessaryfollow-up treatments that can have severeside effects, such as impotence and incontinence.10–11,13–14

More importantly, research to date showsthat patients with prostate cancer whotake the test have no better odds ofsurviving than patients who do not. Thisincludes a recent study of more than71,000 men, which found similarmortality among screened patientscompared to unscreened patients.15 ACanadian study also estimated only 16%of tested men with prostate cancer wouldhave their lives extended by treatment.The rest would have died of anothercause before the cancer had a chance tobecome lethal.16

Exhibit B: Prenatal diagnosis of geneticabnormalitiesNot all early detection strategies areabout prevention. In some cases, they caninstead provide advance knowledge abouta medical condition that already exists.However, sometimes this information canraise a series of difficult or uncomfortabledecisions for some patients.

One example is the practice of examiningfoetuses early in the pregnancy toprovide early knowledge about birthdefects and other problems. This can beaccomplished through many forms ofnon-invasive testing, including combina-tions of blood test and ultrasound.

In the case of genetic abnormalities suchas Down’s syndrome, women consideredby health professionals to be of advancedage for childbirth (usually over age 35)are often offered invasive tests such aschorionic villus sampling in the firsttrimester and amniocentesis in the secondtrimester.17

The accuracy of these diagnostic tests isnot in question. However, they mayoften raise a number of difficult decisionsfor mothers-to-be, including whether ornot to terminate the pregnancy. Althoughmany mothers may appreciate thisinformation, for others this early

detection may result in increased anxietyand even regret at having consented tothe test.18

ConclusionBefore any specific test is put into wide-spread use, patients and practitionersneed to consider whether it is worthwhileand accurate, and whether they would beempowered to do something with theresults.

REFERENCES

1. Prochazka AV, Lundahl K, Pearson W,Oboler SK, Anderson RJ. Support ofevidence-based guidelines for the annualphysical examination. Archives of InternalMedicine 2005;165(12):1347–52.

2. Oboler SK, Prochazka AV, Gonzales R,Xu S, Anderson RJ. Public expectationsand attitudes for annual physical examinations and testing. Annals ofInternal Medicine 2002;136(9):652–59.

3. Laine C. 2002. The annual physicalexamination: needless ritual or necessaryroutine? Annals of Internal Medicine2002;136(9):701–3.

4. Gordon PR, Senf J. Is the annualcomplete physical examination necessary?Archives of Internal Medicine1999;159(9):909–10.

5. Cadman D, Chambers L, Feldman W,Sackett D. Assessing the effectiveness ofcommunity screening programs. Journal ofthe American Medical Association1984;251(12):1580–85.

6. Greenhalgh T. How to read a paper:papers that report diagnostic or screeningtests. British Medical Journal1997;315:540–43.

7. Streiner D L. Diagnosing tests: using andmisusing diagnostic and screening tests.Journal of Personality Assessment2003;81(3):209–19.

8 Kramer B S. The science of earlydetection. Urologic Oncology2004;22(4):344–47.

9. British Columbia Cancer Agency.Screening for Cancer. Vancouver: BritishColumbia Cancer Agency, 2005. Available atwww.bccancer.bc.ca/HPI/CancerManage-mentGuidelines/ScreeningforCancer.htm#7

10. Gibbons L, Waters C. Prostate cancer –testing, incidence, surgery and mortality.Health Reports 2003;14(3):9–20.

11. Coldman AJ, Phillips N, Pickles TA.Trends in prostate cancer incidence andmortality: an analysis of mortality changeby screening intensity. Canadian MedicalAssociation Journal 2003;168(1):31–35.

12. Perron L, Moore L, Bairati I, BernardPM, Meyer F. PSA screening and prostatecancer mortality. Canadian Medical Association Journal 2002;166(5):586–91.

13. U.S. Preventive Services Task Force.Screening for prostate cancer: recommen-dation and rationale. Annals of InternalMedicine 2002;137(11):915–16.

14. U.S. Preventive Services Task Force.Screening for prostate cancer: an update ofthe evidence for the U.S. PreventiveServices Task Force. Annals of InternalMedicine 2002;137(11):917–29.

15. Concato J, Wells CK, Horwitz R et al.The effectiveness of screening for prostatecancer: a nested case-control study.Archives of Internal Medicine2006;166(1):38–43.

16. McGregor M, Hanley JA, Boivin JF,McLean RG. Screening for prostate cancer:estimating the magnitude of overdetection.Canadian Medical Association Journal1998;159(11):1368–72.

17. Alfirevic Z, Sundberg K, Brigham S.Amniocentesis and chorionic villussampling for prenatal diagnosis. TheCochrane Database of Systematic Reviews2003;3(CD003252).

18. Green JM, Hewison J, Bekker HL,Bryant LD, Cuckle HS. Psychosocialaspects of genetic screening of pregnantwomen and newborns: a systematic review.Health Technology Assessment2004;8(33):1 –109.

Stearic acid Observational studies of stearic acid (dietary, orserum levels) generally show that it is associatedwith higher levels of heart disease, either as incidence or mortality. Stearic acid comespredominantly from meat and dairy products, sothere is little surprise there. Stearic acid fromchocolate is a small contributor to stearic acidintake, of about 5% in the average western diet.

Flavenoids in chocolateChocolate, dark or milk, has higher levels offlavenoids or oxygen radical absorbance capacitythan almost any other food, based on weight(Figures 1 and 2) or on energy. Only apples come close.

Chocolate and mechanismsOver 20 small trials have studied the effects ofchocolate on physiological and biochemicalparameters over the short term. The quality ofthe studies and the magnitude of the effectscannot be seen from the review. Several reportedlower blood pressure, decreased low densitycholesterol oxidation, decreased platelet aggregation, improved endothelial function, andgreater antioxidant capacity.

Flavenoids and heart disease The review reports 11 prospective observationalstudies of the association between flavenoidconsumption and heart disease or stroke. Studieswere conducted in populations of 500 to 40,000(about 190,000 people in total), followed up for 5 to 28 years. Most reported some reduction incoronary heart disease mortality. A meta-analysisindicated a significant protective effect betweenflavenoid consumption and risk of coronary heartdisease mortality, with a relative risk of 0.81(95% confidence interval 0.71 to 0.92).

CommentMany different polyphenols contribute to antiox-idants in the diet. There is no absolute need to eatchocolate to get antioxidants. But chocolate has

lots of them, and different ones, and is pretty niceon the whole for most of us. Eating too muchchocolate is not a good idea, though, because ofthe sugar and stearic acid it contains. Like somany other things, a little chocolate taken regularly is likely to be a good thing; a little ofwhat you fancy.

REFERENCE

1. Ding EL, Hutfless SM, Ding X, Girotra S.Chocolate and prevention of cardiovascular disease:a systematic review. Nutrition & Metabolism2006;3:2.


The Case for Chocolate

Bandolier obviously has chocolate lovers among its readers, but chocolate lovers who want ahealthy lifestyle. Can it really be true, they ask, that chocolate can be good for you? Henry'smother's hairdresser's friend was always of the opinion that a little of what you fancy doesyou good, but here a systematic review1 promised some evidence to support any prejudices.

Evidence-based health care

Bandolier is an onlinejournal about evidence-based healthcare, written byOxford scientists. Articlescan be accessed atwww.jr2.ox.ac.uk/bandolier

This paper was firstpublished in 2006. © Bandolier, 2006.

Systematic review The search was limited toEnglish language studiesfound in MEDLINE tomid-2005, which examinedat least one of severalaspects of the relationshipbetween chocolate andcardiovascular health.

ResultsThe review covered about140 publications andlooked at several differentaspects.

Figure 1: Flavenol and procyanadin content ofchocolate compared with other foods high in antioxidants

Figure 2: Oxygen radical absorbance capacity ofchocolate compared with other foods high in antioxidants


NEW PUBLICATIONSEurohealth aims to provide information on new publications that may be ofinterest to readers. Contact Sherry Merkur at [email protected] if you wishto submit a publication for potential inclusion in a future issue.

National strategy to reduce socialinequalities in health

Norwegian Ministry of Health and CareServices

Report No. 20 (2006–2007) to theStorting, February 2007

99 pages

Freely available at:http://www.regjeringen.no/pages/1975150/PDFS/STM200620070020000EN_PDFS.pdf

Translated from Norwegian, this Reportto the Storting (Parliament) lays downguidelines for the government andministry’s efforts to reduce social inequal-ities in health over the next ten years.

It forms part of the government’s broaderpolicy for the reduction of social inequal-ities, promotion of social inclusion andcombating poverty. The strategy aims togovern the ministry’s work on: annualbudgets; management dialogues withsubordinate agencies and regional healthenterprises; legislation, regulations andother guidelines; inter-ministerial collabo-ration; organisational measures; and otheravailable policy instruments.

The report first describes social inequal-ities in health in Norway. Then, policyinstruments to reduce social inequalities inhealth-related behaviours and health careaccess, as well as economic inequalities insociety are discussed. Particular attentionis given to children and young people, thelabour market and workplace. The report

then goes on to argue that targeted, user-oriented and specially adapted publicservices are necessary to ensure that thewhole population has access to equitableservices.

Finally, steps towards reducing socialinequalities in health are highlighted, suchas: an inter-sectoral review; reportingsystem; awareness-raising among decision-makers in all sectors and on all adminis-trative levels; cross-sectoral tools (i.e.health impact assessments, social and landuse planning); stronger partnerships andlocal competencies for public health; andstrengthened research.

Contents: Introduction; Part 1: Reducesocial inequalities that contribute toinequalities in health; Part 2: Reduce socialinequalities in health behaviour and use ofhealth services; Part 3: Targeted initiativesto promote social inclusion; Part 4:Develop knowledge and cross-sectoraltools; Appendix: International experiences.

Hearts and Minds at Work in Europe:A European work-related publichealth report on cardiovasculardiseases and mental ill health

Wolfgang Boedeker and Heike Klindworth

Federal Association of Company HealthInsurance Funds, 2007

ISBN 978-3-9800600-0-4

137 pages

Freely available at:http://www.enwhp.org/fileadmin/rs-dokumente/dateien/Hearts_and_Minds_at_Work_in_Europe.pdf

This report was prepared as part of aEuropean Commission project entitledWorkhealth, that began in Germany in2002.

It begins by reviewing the European literature on disease and the workplace,arguing that although work is recognisedas a risk factor for two of the mostimportant disease groups in Europe –cardiovascular diseases (CVD) and mentalill health – data on the occurrence of thesediseases across occupations and economicsectors are rare. The report also drawsattention to the reverse of this relationship; the impact of disease onwork.

Adding to the complexity are the linksbetween CVD and mental ill health, asboth diseases are potentially causes andconsequences of each other.

The report concludes that because stress isknown to be the most important work-related risk factor for CVD and mental illhealth, sustainable stress prevention is themost effective way to tackle these

problems in the workplace. It argues thatthese interventions show a positive returnon investment. Furthermore, these inter-ventions are most effective when workhealth and public health aspects areaddressed together.

Finally, the report provides recommenda-tions to policy-makers and others,pointing out that effective and sustainablehealth promotion and prevention calls forcollaboration across different professionsand policy fields.

Contents: Introduction; The burden ofCVD and mental ill health on work; Relationship between CVD and mental illhealth; The impact of work on CVD andmental ill health; Strategies for healthyhearts and minds at work; Policy recommendations; Annex A – Structure ofthe workforce in the EU; Annex B –Further readings; Annex C – TheWORKHEALTH II Consortium.


Please contact Sherry Merkur [email protected] to suggest web sites

for potential inclusion in future issues.

Innovative Medicines Initiative(IMI)

http://www.imi-europe.org

Alliance for Health Policy andSystems Research (HPSR)

http://www.who.int/alliance-hpsr/en

WHO International ClinicalTrials Registry Platform

http://www.who.int/ictrp/en

The Alliance for HPSR is a WHO-led international collaboration that aims to promote thegeneration and use of health policy and systems research as a means to improve the healthsystems of developing countries. Its activities are conducted through a secretariat and over 300partners worldwide under priority themes including: health workforce, health financing and therole of the non-state sector in health. The Alliance supports the development of nationalprocesses for evidence-informed policy-making and capacity for the generation, synthesis,dissemination and use of health policy and systems research knowledge. They regularly publisha newsletter, working papers and reports, all of which are available on-line.

Canada Health Infoway

http://www.infoway-inforoute.ca

Launched in 2001, the Canada Health Infoway Incorporated is an independent, not-for-profitorganisation whose members are Canada’s fourteen federal, provincial and territorial DeputyMinisters of Health. Infoway and its public sector partners have over 100 projects aimed atdelivering electronic health record (EHR) solutions to Canadians. The goal is to have an interoperable EHR covering 50% of Canadians by 2010. Details and documents about projects,annual reports, news and events and a newsletter for subscription are available from the website in both English and French.

The objective of the WHO Registry Platform is to provide a complete view of research that isaccessible to those involved in health care decision-making. It also advocates for the public availability of a minimum amount of results information from clinical trials. The web siteprovides several resources including: The Clinical Trial Search Portal, which enables users tosearch a central database that contains trial registration data sets; The WHO Network of Collaborating Clinical Trial Registers that provides a forum for registers to exchange information and work together to establish best practice for clinical trial registration; and a list of primary registers that meet certain requirements and contribute data directly to the WHOSearch Portal. These web sites are available in English.

The IMI is a proposed public-private partnership between the European Federation of Pharma-ceutical Industry and Associations (EFPIA) and the European Commission with the overallgoal of making Europe the world leader in pharmaceutical research. A key feature of the IMIproject is the way different stakeholders work together across Europe, establishing a new typeof collaboration between industry, academia, regulators, health care professionals and patients.The IMI web site is available in English and provides details of the organisation, its objectives,news and events, publications for download and relevant links.

Healthcare Cost and UtilizationProject (HCUP)

http://www.hcup-us.ahrq.gov/home.jsp

Based in the United States, HCUP is a collection of health care databases and related softwaretools and products developed through a Federal-State-Industry partnership and sponsored bythe Agency for Healthcare Research and Quality (AHRQ). HCUP databases bring togetherthe data collection efforts of State and private data organisations, hospital associations and theUS government to create a national information resource of patient-level health care data since1988. These databases enable research on a broad range of health policy issues, including costand quality of health services, medical practice patterns, access to health care programmes, andoutcomes of treatments at the national, State, and local market levels. The English language website provides descriptions of and reports from the databases, related software, fact books andreports for download, news and events, as well as technical assistance.

WEBwatch


Press releases andother suggestedinformation forfuture inclusion can be e-mailed tothe editor David [email protected]

New

sEUROPEAN MONITOR

International Health Regulationsenter into forceIn the early twenty-first century,demographic, economic andenvironmental pressures havecreated a unique combination ofconditions that allow new andre-emerging infectious diseasesto spread as never before. Theexperience of recent decadesshows that no individualcountry can protect itself fromdiseases and other public healththreats. All countries arevulnerable to the spread ofpathogens and their economic,political and social impact.

The emergence and rapid spreadof SARS in 2003 was a clear indi-cation of how globalisation hasmade the world much smaller,creating a need for collectivedefences and for shared respon-sibility in making these defenceswork. This is the underlyingprinciple of the revised Interna-tional Health Regulations thatentered into force on 15 June.The Regulations consist of acomprehensive and tested set ofrules and procedures which areintended to help make the worldmore secure from threats toglobal health.

“SARS was a wake-up call for allof us. It spread faster than wehad predicted and was onlycontained through intensivecooperation between countrieswhich prevented this newdisease from gaining a foothold,”said Margaret Chan, Director-General of the World HealthOrganization. “Today, thegreatest threat to internationalpublic health security would bean influenza pandemic. Thethreat of a pandemic has notreceded, but implementation ofthe IHR will help the world tobe better prepared for the possi-bility of a pandemic.”

Agreed by the World HealthAssembly in 2005, the Regula-tions establish an agreedframework of commitments andresponsibilities for countries andfor WHO to invest in limiting

the international spread ofepidemics and other publichealth emergencies whileminimising disruption to travel,trade and economies. Under theIHR, countries will be requiredto report all events that couldresult in public health emer-gencies of international concern,including those caused bychemical agents, radioactivematerials and contaminated foodwithin 24 hours of assessment.

The regulations also require thatevery country designate aNational IHR Focal Point,charged with providing to andreceiving information fromWHO on a 24 hour basis, sevendays a week. Each country isalso committed to develop andmaintain core public healthcapacities for surveillance andresponse. These capacities alsoinclude outbreaks of chemical,radiological and food origin.Countries are required toestablish these capacities as soonas possible and within a deadlineof five years after entry intoforce of the revised IHR.

The IHR also recognises thatinternational travellers be treatedwith respect for their dignity,human rights and fundamentalfreedoms when health measuresare applied. However, they alsoallow for examinations and otherrequired health measures toprotect against the internationalspread of disease. Existing inter-national disease controlprogrammes, addressing infec-tious diseases, food safety andenvironmental safety will also bestrengthened. These programmesmake a vital contribution to theglobal alert and response systemas they allow the development ofgeneric and threat-specificcapacities.

The IHR also build on therecent experience of WHO andits partners in both respondingto and containing diseaseoutbreaks. Recent experienceshows that addressing publichealth threats at their source isthe most effective way to reducetheir potential to spread interna-tionally. The Regulations will

help to ensure that outbreaksand other public health emer-gencies of international concernare detected and investigatedmore rapidly and that collectiveinternational action is taken tosupport affected countries tocontain the emergency, save livesand prevent its spread.

WHO has already developedand built an improved eventsmanagement system to managepotential public health emer-gencies. It has also been workingwith its partners to strengthenthe Global Outbreak Alert andResponse Network (GOARN),which brings together expertsfrom around the world torespond to disease outbreaks.

David Heyman, WHO AssistantDirector-General for Communi-cable Diseases, noted that while“implementing the IHR is acollective responsibility anddepends on the capacity of allcountries to fulfil the newrequirements, WHO will helpcountries to strengthen thenecessary capacities to fullyimplement the Regulations. Thisis our responsibility and weexpect that the entire interna-tional community is committedto the same goal of improvinginternational public healthsecurity.”

More information on the revisedIHR can be viewed athttp://www.who.int/entity/csr/ihr/en/index.html

World Health Report 2007More than at any previous timein history, global public healthsecurity depends on interna-tional cooperation and the will-ingness of all countries to acteffectively in tackling new andemerging threats. That is theconclusion of this year’s WorldHealth Report published by theWHO in Geneva on 23 August.Entitled A Safer Future: GlobalPublic Health Security in the21st Century, it concludes withsix key recommendations tosecure the highest level of globalpublic health security: fullimplementation of the revisedInternational Health Regulations

MONITOR

26


MONITOR

27

by all countries; global cooperation insurveillance and outbreak alert andresponse; open sharing of knowledge,technologies and materials, includingviruses and other laboratory samples,necessary to optimise secure globalpublic health; global responsibility forcapacity building within the publichealth infrastructure of all countries;cross-sector collaboration withingovernments; and increased global andnational resources for training, surveil-lance, laboratory capacity, responsenetworks, and prevention campaigns.

According to WHO, new diseases areemerging at an unprecedented rate, oftenwith the ability to cross borders andspread rapidly. Since 1967, at least 39new pathogens have been identified,including HIV, Ebola haemorrhagicfever, Marburg fever and SARS. Othercenturies-old threats, such as pandemicinfluenza, malaria and tuberculosis,continue to pose a threat to healththrough a combination of mutation,rising resistance to anti-microbial medi-cines and weak health systems.

“Given today’s universal vulnerability tothese threats, better security calls forglobal solidarity,” said Margaret Chan,Director-General of WHO. “Interna-tional public health security is both acollective aspiration and a mutualresponsibility. The new watchwords arediplomacy, cooperation, transparencyand preparedness.”

World Health Report 2007 traces thehistory of efforts to contain infectiousdiseases (including plague, cholera andsmallpox). It describes the evolution ofoutbreak surveillance and responseactivities of international partnerships ofagencies and technical institutions. Theseinclude GOARN (Global OutbreakAlert and Response Network), thechemical and environmental healthincident alert and response system, andthe Global Polio Eradication Initiative,which is supporting surveillance ofmany other vaccine-preventable diseases.

It shows how and why diseases areincreasingly threatening global publichealth security. High and rapid mobilityof people is one factor. Airlines nowcarry more than two billion passengers ayear, enabling people and the diseasesthat travel with them to pass from onecountry to another in a matter of hours.The potential health and economicimpact was seen in 2003 with SARS,

which cost Asian countries an estimatedUS$ 60 billion in gross expenditure andbusiness losses.

Some of the human factors behindpublic health insecurity identified in thereport, include inadequate investment inpublic health resulting from a false senseof security in the absence of infectiousdisease outbreaks; unexpected policychanges such as a decision temporarilyto halt immunisation in Nigeria, whichled to the re-emergence of polio; conflictsituations when forced migration obligespeople to live in overcrowded, unhy-gienic and impoverished conditionsheightening the risk of epidemics;microbial evolution and antibioticresistance; and animal husbandry andfood processing threats such as thehuman form of bovine spongiformencephalopathy (BSE) and Nipah virus.

The report also sets out the WHOstrategic action plan to respond to aninfluenza pandemic, drawing attentionto the need for stronger health systemsand for continued vigilance in managingthe risks and consequences of the inter-national spread of polio and the newlyemerging strain of extensively drug-resistant tuberculosis (XDR-TB). Newhealth threats have also emerged, linkedto potential terrorist attacks, chemicalincidents and radionuclear accidents.

World Health Report 2007 is available inEnglish, French and Spanish athttp://www.who.int/entity/whr/2007/

New country specific data on impact ofenvironmental factors on healthOn 13 June the World Health Organi-zation released the first ever country-by-country analysis of the impactenvironmental factors have on health.The data show huge inequalities but alsodemonstrate that in every country,health could be improved by reducingenvironmental risks including pollution,hazards in the work environment, ultra-violet radiation, noise, agricultural risks,climate and ecosystem change.

The new data show that 13 milliondeaths worldwide could be preventedevery year by making environmentshealthier. In some countries, more thanone third of the disease burden could beprevented through environmentalimprovements. Measure might includeusing cleaner fuel such as gas or elec-tricity, using better cooking devices,improving the ventilation or modifying

population behaviour (such as keepingchildren away from smoke) could have amajor impact on respiratory infectionsand diseases among women andchildren. Reducing levels of airpollution, as set out in WHO’s AirQuality Guidelines, would save an esti-mated 865,000 lives per year.

Low income countries suffer the mostfrom environmental health factors,losing about twenty times more healthyyears of life per person per year thanhigh income countries. However, thedata show that no country is immunefrom the environmental impact onhealth. Even in countries with betterenvironmental conditions, almost onesixth of the disease burden could beprevented, and efficient environmentalinterventions could significantly reducecardiovascular disease and road trafficinjuries.

Commenting on the publication of thenew country estimates, Susanne Weber-Mosdorf, WHO Assistant Director-General for Sustainable Developmentand Healthy Environments said thatthey were “a first step towards assistingnational decision-makers in the sectorsof health and environment to set prior-ities for preventive action.”

Meantime, in a presentation at the Inter-governmental Midterm Review of ChildHealth and Environment Action Plansin Vienna on 13 June, Roberto Bertollinifrom the WHO Regional Office forEurope’s Special Programme on Healthand Environment, made use of this datato report that there are 5,000 preventabledeaths every day in the European region.Well tested environmental health inter-ventions, he argued, could reduce totaldeaths in Europe by almost 20%, some1.8 million lives every year. The range ofyears of life lost to environmental factorsvaried fourfold across the continent,with the lowest levels of risk reported innorthern and western European coun-tries. The highest rates are all in theeastern part of the region: in the RussianFederation 54 disability adjusted yearsof life are lost per 1,000 population everyyear with similarly high rates of 49,48,47and 46 years of life lost per 1,000 popu-lation in Kazakhstan, Turkmenistan,Tajikistan and Kyrgyzstan respectively.Within the EU the highest rate of yearsof life lost, 39 per 1,000 population is tobe found in Estonia, closely followed byits neighbours Latvia and Lithuania with38 and 34 years of life lost respectively.

Dr Bertollini emphasised that childrenwere particularly vulnerable to theseenvironmental factors. The importanceof taking more action to protect childrenwas also emphasised in a prior meetingin Vienna where Lisette Van Vliet,Toxics Policy Advisor, at the nongovernmental Health and EnvironmentAlliance, stated that development of thefoetal brain can be disrupted byexposure to hazardous chemicals atlevels that would be less damaging foradults.

Priorities for health under thePortuguese PresidencyThe centre piece of actions for healthunder the Portuguese Presidency will bethe issue of migration. A conferenceentitled Health and Migration in the EU– better health for all in an inclusivesociety will be held in Lisbon on 27–28September. It has the aim of mobilisingMember States, national and interna-tional organisations and non govern-mental organisations to discuss andwork on proposals of interventionstrategies and policies, in order topromote health, prevent disease andimprove access to health care formigrants.

Specifically, the Conference’s objectiveswill be: to assess the twenty-first centuryinternational migration moves and theirimpact on EU demography and theeconomy; to improve knowledge onmigrants’ health status and health deter-minants (accounting for the demo-graphic dynamics of the migratoryprocess and its impact; the specificpolitical and legal frameworks at bothnational and international levels; thesocioeconomic integration of migrantfamilies); to identify best practices aboutmigrants’ access to health services(health promotion, prevention andaccess to care), encompassing formal andinformal care, as well as social andcultural activities aimed at facilitatinginclusion; and to contribute to the defi-nition of health policies and strategiesaimed at improving migrants’ inte-gration, which could be implemented atboth EU and Member States levels.

Another priority is the European HealthStrategy. A round table on healthstrategies in Europe was held on 12–23July in Lisbon with the aim of furtheringthe debate. The programme includedparallel sessions on disease specificstrategies: cancer, cardiovascular,

diabetes, gender-sensitive strategies,obesity, oral health and tuberculosis.

At a global level, the Presidency haspledged to pay special attention to arange of global health issues, inparticular in what concerns the WorldHealth Organization, coordinatingcommunity positions in the field oftobacco control (at the 2nd Conferenceof the Parties of the WHO FrameworkConvention on Tobacco Control), at the2nd Meeting of WHO’s Intergovern-mental Working Group on PublicHealth, Innovation and IntellectualProperty, at the meeting of WHO’sIntergovernmental Working Group onsharing of influenza virus samples andon the implementation of the Interna-tional Health Regulations.

The Presidency themes are consistentwith the focus on health promotion,disease prevention, access to health careand innovation agreed as part of an 18month programme with the Slovenianand German presidencies. It has alsopledged to continue to develop the‘Health in All Policies’ initiative estab-lished under the Finnish presidency.

To this end a meeting of the workinggroup on Health and Health SystemsImpact Assessment (HIA/HSIA) willtake place in Lisbon on 5–6 November.This is one of the subgroups of the HighLevel Group on Health Services andMedical Care of the EuropeanCommission. It aims to develop meas-urement tools on the impact of EUpolicies on health and health systems.Following up the work of this group andthe Kuopio Conference on Health In AllPolicies during the EU Finnish Presi-dency, a network of experts, recentlyestablished, will be strengthened. Themain themes to be covered will includeHIA and HSIA methodologies of imple-mentation and procedures in MemberStates of the EU; as well as planned orongoing HIA and HSIA, includingCommission funded projects. It is hopedto further develop a European networkon HSIA and publication and dissemi-nation of the conference results.

Work begun under the German presi-dency on both HIV/AIDs and pharma-ceutical innovation will continue. On12–13 October, a meeting of EU nationalAIDS coordinators will take place inLisbon with a focus on consolidating thecollaboration between European coun-tries, with regards to the fight against

infection in both the WHO EuropeanRegion and the EU NeighbouringCountries. The meeting will also be opento all countries of WHO Europe Regionand other Neighbouring Countries.

Again this meeting is linked into theoverarching theme of migration andhealth in the Presidency programme.Key objectives include reporting on thepresent situation in the EU, WHOEuropean Region and neighbouringcountries, identifying incentives andbarriers to HIV prevention, treatmentand support to migrant and mobilepopulations, namely national legislation,policies and practices. Furthermore, it ishoped to reach a consensus on theexisting gaps and obstacles whenreporting HIV impact on migrant andmobile populations and to agree onpriorities and processes to address iden-tified shortcomings.

A conference on pharmaceutical inno-vation will take place in Lisbon from19–20 November. The Conferenceprogramme will focus on the discussionof the current pharmaceutical researchand innovation model at EU level,analysing innovation’s main currentchallenges related to its definition andquantification, financing and new R&Dtechnologies. How regulators will adaptregulatory environments to the newscientific changes, promote cooperationamong stakeholders, namely throughpartnerships, as well as the main reasonfor the loss of competitiveness of Europein comparison with the US, will also bediscussed. It is envisaged that this willresult in the release of a set of concreterecommendations and solutions for thefuture of the pharmaceutical innovationsector.

More on the health priorities of thePortuguese Presidency can be viewed athttp://www.eu2007.min-saude.pt/PUE/en/conteudos/programa+da+saude/presidencys.htm

European Commission, businesses andNGOs create forum to battle alcohol-related harmOn 7 June in Brussels, over forty busi-nesses and non-governmental organisa-tions signed the Charter establishing theAlcohol and Health Forum. The Forum,scheduled to meet twice a year, is tofocus in particular on actions to protectchildren and young people and toprevent irresponsible commercialalcohol communication and sales. EU


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Member States, European Institutions,the World Health Organization and theInternational Organisation of Vine andWine will participate as observers.

Previously in October 2006, theEuropean Commission adopted aCommunication setting out an EUAlcohol strategy to support MemberStates in reducing alcohol related harm.The priorities identified in the Commu-nication were: to protect young peopleand children; reduce injuries and deathsfrom alcohol-related road accidents;prevent harm among adults and reducethe negative impact on the economy;raise awareness of the impact on healthof harmful alcohol consumption; andhelp gather reliable statistics. Ways inwhich the EU could support MemberStates’ actions to reduce alcohol-relatedharm included exchange of good practiceon issues such as curbing under-agedrinking, exploring cooperation oninformation or tackling drink-driving.

The move to establish the new Forumcomes at a time when an estimated200,000 Europeans die every yearbecause of harmful alcohol use. Morethan one out of four deaths amongyoung men is attributed to alcohol.According to the recently publishedspecial Eurobarometer on Alcohol, onein ten Europeans usually drink five ormore drinks in one session, which is thewidely used definition of binge drinkingfor men. This figure was particularlyhigh among the youngest respondents.Almost one in five young people in the15–24 age group (19%) drink five ormore alcoholic beverages in one session.

The Forum will establish a ScienceGroup which, on request, will providescientific advice and guidance on mattersunder discussion. The Forum can alsoestablish Task Forces. The first two havealready been established and covermarketing communication and youth-specific aspects of alcohol.

In order to become a member of theForum, a business or NGO has tosubmit a written commitment to takeaction. In other words, all the membershave to present a concrete action planwith objectives and information on howthe results will be monitored and eval-uated. Participation for the sake ofparticipation will not be possible asmembers will need to report on whatthey have done and their achievements.

Furthermore, all action plans and

commitments will be made public and allwill be observed within one single moni-toring framework. The results will alsobe made public through DG Health andConsumer Protection’s website. Thiswill allow the evaluation of successfulinitiatives, which, in turn could beexamples for the other members of theForum to follow.

In a speech at the launch of the Forum,European Union Commissioner forHealth and Consumer Protection,Markos Kyprianou, welcomed theparticipation of such an impressivegroup of partners in the fight againstalcohol related harm. He did howevercaution that more would need to comeout of the Forum than the alreadyannounced actions to protect childrenand young people and promote respon-sible commercial communication andsales.

He noted that all stakeholders hadcritical roles to play saying that heexpected the forum “as representativesof the alcoholic beverages industry todevelop, distribute and market yourproducts in a responsible manner. WhileI know that much has been done already,there is much scope for further actionsregarding advertising, server training,product presentation, and so on. I expectyou as representatives of other economicoperators to take on your part of thework; we all know that media, adver-tisers, retailers, owners of pubs and barsplay an extremely important role inchanging attitudes and behaviours, espe-cially among young people. I also expecta broad involvement of NGOs and Iwould welcome active participationsfrom NGOs outside the public healthfield; representing social, youth, familiesand consumer interests; while of courserespecting each organisation’s scale ofresources.”

The Charter establishing the EuropeanAlcohol Health Forum can be found at:http://ec.europa.eu/health/ph_determi-nants/life_style/alcohol/alcohol_charter_en.htm

The special Eurobarometer on Alcohol isavailable at: http://ec.europa.eu/health/ph_publication/eurobarometers_en.htm

Commission consultation on the longterm future of pharmaceuticals.On 19 July Directorate General Enter-prise and Industry initiated a publicconsultation on how to improve the

long-term future of pharmaceuticals inEurope. The consultation is particularlytargeted at enhancing the regulatory,non-regulatory and research & devel-opment frameworks for the pharmaceu-tical industry.

The objective is to address the publichealth, scientific and economic chal-lenges that the Commission believes arebeing faced by the EU pharmaceuticalindustry. These include increased global-isation of the pharmaceutical sector andensuring the smooth functioning of theinternal pharmaceutical market in anenlarged EU. The Commission alsobelieves that the pharmaceutical industrywill have to adapt in response toadvances in science and technology.

According to the Commission, globali-sation in the pharmaceutical sector stim-ulates a need to improve thecompetitiveness of EU pharmaceuticalcompanies to take advantage of newopportunities and to access foreignmarkets. Globalisation also reinforcesthe need to maintain local EU researchand development capability; as theCommission document states “thecentre of gravity for worldwide R&Dinvestment in the field is graduallymoving to the United States and Asia.Europe should strive to regain territoryit covered for most of the 20th century,when it used to be the home for pharma-ceutical innovation.”

The Commission believes that the func-tioning of the EU internal pharmaceu-tical market could be improved by betterregulation in, for example, the areas ofclinical trials or variations to marketingauthorisations. It notes that someexisting regulations may be overbur-dening and affect competitivenesswithout always bringing public healthbenefits. It also suggests that improve-ments to the internal market could bemade by enhancing the transparency andharmonisation of national pricing andreimbursement schemes. The importanceof patient safety is also emphasised withthe paper stating that “recent analysishas demonstrated the existence ofmultiple and sometimes inefficientrequirements as regards pharmacovigi-lance in the EU. The challenge is thus tostrengthen and rationalise drug safetymonitoring, while avoiding unnecessaryrequirements that would impair patients’access to treatments.” Globalisation ofthe market can also contribute toincreases in counterfeit medicines that,

in turn, produce a greater need toprotect the health of EU citizens.

The consultation document includes alist of six key questions that respondentsshould use as guidance for their contri-butions. In addition to invitingcomments on the main challengesoutlined in the consultation document,other questions include a request forconcrete measures to ensure the safety ofmedicines supplied in the EU,addressing in particular counterfeitmedicines, and the provision of highquality and affordable medicines to thirdcountries.

The Commission would also likesuggestions on how to improve Europe’sinternational competitiveness and fosterconvergence and transparency as regardspricing and reimbursement in the EU.Views are also requested as to the appro-priateness of the current EU regulatoryframework for emerging technologieslike regenerative and personalisedmedicine, as well as nanotechnology.

Responses are due by 12 October.Following this public debate, theCommission intends to address aCommunication to the Council of theEuropean Union and to the EuropeanParliament on the future of the EUsingle market in pharmaceuticals forhuman use, outlining its vision andstrategy for the sector, as well asconcrete action items. The Communi-cation will build on this public consul-tation and will outline how its outcomewas taken into account.

The consultation can be viewed athttp://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_07/consultationpaper-2007-07-19_en.pdf

European Heart Health CharterlaunchedOn 12 June the European Heart HealthCharter was launched at the EuropeanParliament. It was signed on behalf offourteen European professional andpublic health organisations in thepresence of representatives of MemberStates, national cardiac societies andheart foundations. European UnionCommissioner for Health andConsumer Protection, MarkosKyprianou and WHO Deputy RegionalDirector for Europe, Dr Nata Menabde,were also present.

Cardiovascular disease (CVD) is respon-

sible for over half (52%) of deaths in theWHO European Region and almost aquarter (23%) of its disease burden(measured in Disability Adjusted LifeYears – DALYs).

Heart disease and stroke are leadingcauses of death in all WHO EuropeanMember States, but there are wideninggaps between the eastern and westernparts of the Region. While CVDmortality rates have been falling inwestern Europe in recent decades, a risecan be seen in the more easterly parts ofthe Region, with an almost ten-folddifference in premature CVD mortality(deaths in people under 65 years of age)emerging between countries. CVDmortality is a major contributor to thealmost 20-year difference in healthy lifeexpectancy between the countries of theWHO European Region. The economiccosts are also substantial: in 2003, CVDwas estimated to have cost the EUeconomy €169 billion.

The aim of the Charter is to substan-tially reduce the burden of cardiovas-cular disease in the European Union andthe WHO European Region and toreduce inequities and inequalities indisease burden within and betweencountries. The Charter highlights theimportance of governmental action, inpartnership with non-governmental andpublic health organisations, to createsupportive policies and environmentsthat help people adopt healthy types ofbehaviour. An estimated 80% of heartdisease, stroke and type 2 diabetes couldbe avoided if major risk factors wereeliminated, but concerted action isneeded to reduce the numbers ofsmokers and reverse obesity trends incountries, as well as to implement bestpractice in cardiovascular care.

Commenting on the Charter ProfessorGeorgs Andrejevs, a member of theEuropean Parliament’s Committee onthe Environment, Public Health andFood Safety, said that “it is not aiming ata unified stance on health care; butrather at achieving high standards intackling CVD throughout the EU. It is alever for better policies on, for example,the detection and management of peopleat high risk and on care for those whosuffer from CVD. To that extent itrepresents a real tool in the promotionof public health.”

More information on the Charter isavailable at http://www.heartcharter.eu/

European Commission adopts WhitePaper on Sport On 11 July the European Commissionadopted its first comprehensive initiativeon sport. The White Paper recognisesthe important social and economic rolesof sport, while respecting the require-ments of EU law. It is the result ofextensive consultations over the past twoyears with sport organisations, such asthe Olympic Committees and sportfederations, as well as with MemberStates and other stakeholders, includingan online consultation launched inFebruary this year to which theCommission received 777 replies.

Ján Figel, European Commissioner incharge of Education, Training, Cultureand Youth, said “this White Paper is theCommission’s contribution to theEuropean debate on the importance ofsport in our daily lives. It enhances thevisibility of sport in EU policy-making,raises awareness of the needs and speci-ficities of the sport sector, and identifiesappropriate further action at EU level.”

The White Paper proposes concreteactions in a detailed Action Plan namedafter the founder of the modernOlympic Games Baron Pierre deCoubertin. The Plan, in particular,addresses the social and economicaspects of sport, including public health,education and social inclusion. Specifi-cally it includes proposals to developnew physical activity guidelines and tocreate a EU Health-Enhancing PhysicalActivity network. There will also be theaward of a European label to schoolsactively supporting physical activities,while a range of EU programmes andfunds including Progress, LifelongLearning, Youth in Action, Europe forCitizens, the European Social Fund, theEuropean Regional Development Fundand the European Integration Fund willbe mobilised to improve opportunitiesfor supporting social inclusion and inte-gration through sport activities.

EU sports directors discussed the WhitePaper in a meeting that took place inLisbon on 12–14 July. In response to thehealth messages outlined in the WhitePaper, the directors highlighted theimportance of physical activity in“improving individual and public health,quality of life and life expectancy, withbenefits that range far beyond thestruggle against obesity and have a majorimpact on medical care costs”.


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The meeting conclusions urged govern-ments, sports federations, the educationsector, urban planning, transport and themedia to work more actively to promotephysical activity and “create a livingenvironment that encourages the largestnumber of people to become physicallyactive”.

The White Paper on Sport will now bediscussed by the European Parliament,the Council, the European Economicand Social Committee and theCommittee of the Regions. Its findingswill also be presented to EU sportministers.

In October, the Commission willorganise a conference to discuss theWhite Paper with sport stakeholders.

The White Paper is available athttp://ec.europa.eu/sport/index_en.html

Commission and UEFA launch TV advertto promote physical activityThe European Commission and theUnion of European Football Associa-tions (UEFA) will launch a joint TVadvertising campaign that aims toencourage European citizens to makephysical activity part of their daily lives.The thirty second advert encouragesviewers to get out of their armchairs andbe physically active, using the slogan“Go on, get out of your armchair”. It isexpected to reach between eighty andone hundred million viewers during eachmatch week of the Champions League,as it will be aired free of charge in morethan forty European countries at theinterval of each of this season’s 125 tele-vised Champions League football games.This has been possible through a part-nership with UEFA which has offeredup the thirty seconds of airtime that itretains for social initiatives. It is thelatest initiative from UEFA to promotehealth through football (see news articlefrom Georgia).

The advert is a product of co-operationbetween the Commission’s Health andConsumer Protection DirectorateGeneral, UEFA and the London-basedAbbott Mead Vickers.BBDO advertisingagency at a total production cost of€515,000. The Commission had askedthe European Association of Communi-cations Agencies to invite its membercompanies to make proposals to workon the project and AMV.BBDO’ssubmission was chosen. The agencyprovided all creative and management

services free of charge.

The initiative comes at a time when poordiets and low levels of physical activityin Europe account for six of the sevenleading risk factors for ill health. Thelack of physical exercise, coupled withunbalanced diets, has turned obesity intoa serious public health problem: obesityrelated illnesses are estimated to accountfor as much as 7% of total health carecosts in the EU. Studies show that one inthree Europeans do not exercise at all intheir free time, while the averageEuropean spends over five hours a daysitting down. In most EU MemberStates more than half of the adult popu-lation is overweight or obese. It is alsoestimated that almost 22 million childrenare overweight in the EU and each yearthis figure is growing by 400,000. Youngpeople tend to retain excess weightthroughout their adult lives and aremore likely to become obese.

COUNTRY NEWS

UK and Germany announce International Health PartnershipOn 22 August, UK Prime MinisterGordon Brown and German ChancellorAngela Merkel announced the formationof a new international initiative, theInternational Health Partnership, as partof a global campaign to address theHealth Millenium Development Goals(MDGs) and equivalent to the coordi-nation process of the Fast TrackInitiative on education, between devel-oping countries and, donors, interna-tional health agencies and foundations.The aim of the initiative is to accelerateprogress towards MDGs 4, 5 and 6,namely, reducing child and maternalmortality, and tackling specific diseasessuch as HIV/AIDS by increasing accessto and use of health services and deliv-ering improved outcomes. The newinitiative will be officially launched on 5September. It will bring together majordonor countries, including the UK,Germany and Norway, alongside inter-national agencies including the WorldBank and the World Health Organi-zation.

Referring to the G8’s commitmenttowards the improvement of health indeveloping countries outlined earlier inthe year, in a joint statement the PrimeMinister and the Chancellor affirmedthat they were “taking steps working

with others to convert our promises intoaction.”

While acknowledging the progress thathas already been made, including morethan doubling aid for health from $6billion in 2000 to $14 billion in 2005; a60% decline in measles-related deaths,and increased access of two millionpeople to HIV/AIDs treatment, the twoleaders stated that they recognise thechallenges ahead. Much of the increasedaid in recent years has targeted specificinterventions but has not built strongsustainable health systems that areessential to deal with all the major causesof ill health. And we know that weaksystems - the lack of health workers,clinics, supplies of essential medicinesand lack of sustainable health financingsystems - are the main barriers tomaking more rapid progress inimproving health outcomes.”

They noted that “of the MDGs, thosefocussing on health are the least likely tobe met…half a million women still dieunnecessarily every year in childbirth,ten million children do not reach theirfifth birthday, and only one in four ofthose in need of AIDS treatment inAfrica is able to receive it.”

They added that “global health assis-tance is over complex with manydifferent health partnerships and interna-tional organisations providing supportthrough separate aid channels, leading inmany cases to fragmented healthprovision on the ground. These competefor limited trained staff and can functionoutside the recipient countries’ prioritiesand structures. This fragmentation hasundoubtedly reduced the effectiveness ofmuch aid.”

The agreement, developed with bilateral,international health and fundingagencies, developing countries, andfoundations commits all partners to:working with country owned plans;creating a mechanism to agree donorsupport to national plans; coordinatingtheir efforts on the ground; andfocussing on the creation of sustainablehealth systems which deliver improvedoutcomes. It is expected that partnerswill coordinate their actions in order toensure that health plans are welldesigned, well supported and well imple-mented.

The importance of helping countriesdevelop strong health financing systemswas also reiterated by the leaders empha-

sising the G8’s commitment to the“Providing for Health” initiative aimedat helping countries develop strongnational health financing systems whichcan ensure universal coverage. Theystated that “this process will be closelyand systematically linked and provideinput to the Health Partnership in orderto enhance sustainable structures foraccessible and pro-poor health systems.”

One major international non-govern-mental organisation, Oxfam, immedi-ately welcomed this health initiative,recognising that it will help to target aidtowards the health needs of poor coun-tries. Alison Woodhead, head ofOxfam’s international campaign forhealth and education, said that it was “agreat initiative that deserves widespreadinternational support. Brown andMerkel should be congratulated forfollowing through on their G8 promisesto improve health care. The challenge forthem now is to make sure other coun-tries get on board to ensure maximumimpact. There are women, men andchildren in developing countries who aredying because they don’t have access tohealth care or any doctors or nurses toattend to them. This Partnership couldliterally save lives, by coordinatinginvestment in health care that is free,public and well staffed. “

The full joint statement of the PrimeMinister and the Chancellor can beviewed at http://www.number-10.gov.uk/output/Page12904.asp

UK: Inquiry claims mental healthservices are letting down older peopleA mental health pandemic and an inade-quate Government response mean thatover 3.5 million older people who expe-rience mental health problems do nothave satisfactory services and support,according to the final report from theUK Inquiry into Mental HealthandWellBeing in Later Life – a majorindependent inquiry supported by theUK-based NGO, Age Concern.

The Inquiry makes 35 recommendationsfor ways to improve mental healthservices for older people. It calls foraction to: eliminate age discrimination inmental health; challenge stigma, ageismand defeatism; work on preventingproblems; support older people and theircarers to help themselves and each other;and improve housing, health and socialcare services. It also calls for governmentaction to provide leadership and over

turn what it deemed as “years of underfunding” in older people’s mental health.

The Inquiry report reveals that mentalhealth problems affect many morepeople in later life than previouslybelieved and that the nature of theseproblems is wider than often recognised.It reveals that up to 2.6 million olderpeople, one in four people over 65 andtwo in five people over 85, are livingwith depression or serious symptoms ofdepression and one in five people over80 have dementia. It also highlights thatolder people with mental health servicesare often ignored and receive littlesupport services, and there exists a poorlevel of services for people growingolder with longstanding mental healthproblems such as schizophrenia. Womenover 75 the report claims, are more likelyto take their own lives compared to anyother age group, while men over 75 havethe second highest suicide rate of all menin the UK.

Chair of the Inquiry, June Crown, saidthat “Mental health problems in later lifeare not an inevitable part of ageing. Theyare often preventable and treatable, andaction to improve the lives of olderpeople who experience mental healthdifficulties is long overdue. Currentservices for older people with mentalhealth problems are inadequate in range,in quantity and in quality.”

The report also estimates that olderpeople make a valuable contribution tothe economy and this is growing inabsolute and relative terms. By 2021, theunmet mental health needs of olderpeople will cost £230 billion per year inlost workers, £15 billion from theabsence of older carers, £5 billion fromlost volunteers, £4bn from lost grand-parents and £245 billion from lostconsumers.

The full report can be accessed athttp://www.mhilli.org/

UK: Government committed to revisionof pharmaceutical pricing arrangements Drugs pricing arrangements between theNational Health Service and pharmaceu-tical companies should be updated,according to Competitiveness Minister,Stephen Timms, publishing theGovernment’s interim response on 2August to a recent report from theOffice of Fair Trading (OFT).

The OFT report questioned whether theexisting PPRS (Pharmaceutical Pricing

Reimbursement System), whichcombines restrictions on profits andprice controls, is achieving both value formoney and ensuring the contribution ofthe UK pharmaceutical industry toimproved health care quality andeconomic prosperity. It recommendedthe replacement of the current systemwith a new system of value based pricing.

Timms said, “we agree with the OFTthat it is time to develop a pricing systemwhich is fit for purpose for the twentyfirst century. We must ensure that anyfuture pricing scheme delivers value,rewards innovation and ensures a fairdeal. The OFT report contained anumber of detailed proposals as to howa future pricing regime would work. Weare undertaking a continuing programmeof detailed analysis of the OFT report’sproposals, and will discuss this analysiswith the industry, taking into accounttheir strong concerns about a number ofthe proposals. This is a highly complexarea and there are a number of differentmodels for taking work forward. We willtake this work forward over the comingmonths and will discuss proposals withindustry. We will then aim to makefurther proposals as part of the renegoti-ation of the PPRS.”

The government’s initial response recog-nises that since the PPRS was establishedfifty years ago, significant changes haveoccurred, both in the pharmaceuticalindustry and in the delivery of healthcare. It notes that blockbuster drugs arerare, with innovation now increasinglyfocused on ever-smaller patient popula-tions, creating major challenges inensuring affordable delivery of thesebenefits to patients. Although inagreement that changes need to be made,the government is mindful of the need toensure that any pricing system willencourage research and reward inno-vation which delivers valuable new treat-ments. Any future pricing scheme mustalso provide stability, sustainability andpredictability for industry.

The OFT report on the PharmaceuticalPrice Regulation Scheme can be foundat: http://www.oft.gov.uk/advice_and_resources/resource_base/market-studies/price-regulation.

Ireland: Review finds 13% of patientsadmitted to hospital unnecessarilyThe Health Service Executive (HSE) on1 June published its Acute Hospital BedUse Review. The review found that 13%


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of patients were unnecessarily admittedto hospital and that 39% of the patientsin hospitals surveyed could have beentreated in an alternative setting on theday of care, if appropriate alternativeshad been available. The review wasconducted across 37 hospitals and a totalof 3,035 patients were randomly sampledout of a patient population of 8,322.Acute medical and surgical inpatientswere the focus of the review.

The findings will be used by the HSE todrive hospital performance improvementand the re-configuration of services toachieve an increase in the levels ofappropriate placement of patientsoutside of hospital settings and reduceinappropriate admissions, as well as anover-dependence on the hospital system.

The work was carried out using theAppropriateness Evaluation Tool (AEP)– a method originally developed in theUS but widely used in Europe. The prin-cipal alternatives to acute admissionidentified for these patients were: accessto assessment/diagnostics withoutadmission to a hospital; access to a non-acute bed with therapy support, forexample, physiotherapy; and home-based patient care including generalpractitioner support, therapy, specialistnursing, community nursing and homecare packages.

The findings suggest that change acrossthree main areas would reduce thenumber of patients deemed ‘inappro-priate’ based on AEP criteria. First,better prevention and management ofchronic illness within the community toreduce demand on the acute hospitalsetting. Second, further developingcapacity in responsive community basedservices, to help avoid unnecessaryadmissions to acute care and to facilitateearlier discharge and a return to inde-pendence. Third, changing internalorganisational factors within hospitalsthat can influence length of stay, bedoccupancy and bed utilisation.

Dr Marie Laffoy, Assistant NationalDirector for Strategic Planning in theHSE’s Population Health Division,emphasised that “detailed analysis of thedata shows that the most importantfactor influencing appropriate placementof a patient is the system of care deliveryrather than factors concerning thepatients themselves. It is not thecomplex nature of the patient conditionor the fact that the patient is old or lives

alone, but the way local health systemsare configured to treat and care for thatpatient that results in inappropriateoccupancy of an acute bed. A broadrange of community and home-basedcare options are needed to ensurepatients are placed in the most appro-priate setting.”

John O’Brien, National Director and themanager who headed up the WinterInitiative, observed that the report indi-cates that “the solution for many of thelogjams within our hospitals mayactually lie outside those hospitals…there are many patients occupying bedswho would not be doing so if there werealternative community-based options.”

The Acute Hospital Beds Review isavailable at http://www.hse.ie/en/Publications/HSEPublicationsNew/AcuteHospitalReportsGuidelines/AcuteHospitalBedReview2007/reports/FiletoUpload,7020,en.pdf

Scotland: New measures to tacklehealth care associated infectionsA task force set up to tackle health careassociated infections (HAI) is to step upits work following the publication on 11July of the most comprehensive studyever undertaken into the extent of infec-tions in Scotland’s hospitals. Scotlandnow has a more comprehensive pictureof HAI than any other country inEurope and armed with this informationwill be able to target measures to tacklehospital infection where they are mostneeded.

The National HAI Point PrevalenceSurvey, carried out by Health ProtectionScotland between October 2005 andOctober 2006, included all 45 acutehospitals and a sample 22 communityhospitals, recording the presence of alltypes of infections on the day of thesurvey. It found that the prevalence ofHAI was 9.5% in acute hospitals and7.3% in community hospitals. Thesurvey also estimates for the first timethe total cost of HAI in acute hospitals –£183 million a year. The study alsofound that the highest numbers of HAIin acute hospitals were present in thecare of older people, medical andsurgical wards. Almost all (92%) of theClostridium difficile infections recordedwere found in the care of older peopleand medical specialties.

In response to the report, the HAI TaskForce will focus their efforts on a

number of target areas including exam-ining the case for introducing an MRSAscreening programme; targeting skin andsoft tissue infections; reducing bloodstream infections and ensuring addi-tional surveillance data are put to use inthe areas of general medicine and care ofthe elderly

The Scottish Minister for Health andWellbeing, Nicola Sturgeon, said that the“study is one of the most detailed of itskind in the world. For the first time, wehave a true picture of the extent of infec-tions in our hospitals. The compre-hensive nature of the survey means thatit may appear Scotland’s rates of HAIare worse than elsewhere. This is notnecessarily the case – like for likecomparisons with other countries,including England and Norway, showthat Scotland’s rates are similar. But HAIis a serious problem that must betackled.”

The Scottish Executive’s HAI task forceoversees an extensive, high qualityprogramme of action which so far hasincluded developing a HAI code ofpractice, developing a national cleaningservices specification, introducing anational hand hygiene campaign, intro-ducing targets for board chief executivesto meet and the introduction of educa-tional initiatives like the CleanlinessChampions programme.

The Scottish government have alsostated that new investment in tacklingHAI beyond 2007–08 will form part ofthe spending review announcement laterin 2007. The Point Prevalence Surveywill also be carried out at intervals infuture to evaluate trends in HAI.

More information on the survey athttp://www.hps.scot.nhs.uk/news/spdetail.aspx?id=105

Russia: New rules for children’s organtransplantsIn July the Ministry of Health and SocialDevelopment announced plans todevelop instructions regulating thetransplantation of organs to children. Atpresent, child donors are prohibited, butthe Ministry plans to legalise organtransplants from children. The rules arecurrently being studied by the RussianAcademy of Sciences’ Medical ResearchInstitutes. It is expected that the revisedinstructions will require that organs fortransplants are taken from patients afterbrain death, a diagnosis that must be

confirmed after twelve hours. Such deci-sions would be made by a team of expe-rienced medics led by the chief doctor ofthe hospital in question. The permissionof the donors’ families would also berequired.

The new legislation would bring Russianpolicy into line with most high incomecountries which allow children to beorgan donors after their deaths.Currently Russians are forced to taketheir children abroad for such opera-tions, although the associated high costsare prohibitive for most individuals. Thepotential demand for such operations issignificant. According to the MoscowOrgan Donation Coordinating Centre,30% of the 5,000 Russians who needorgans transplants each year arechildren. The plans have been welcomedby many health care professionals, butsome activists oppose the proposedlegislation, arguing that it is immoral andcould lead to the mass abuse of rules bydoctors.

More information at: http://en.rian.ru/russia/20070713/68920290.html

Head of Russian pharmaceuticalcompany Protek charged with briberyOn 17 August, prosecutors in Moscowsaid that they had charged VitalySmerdov, the head of the Protek pharma-ceutical company, with bribing healthinsurance officials in order to receivesales licenses. Smerdov was previously awitness in a high profile inquiry intopossible corruption in Russia’sMandatory Medical Insurance Fund(FOMS) which opened late last year.FOMS executives had been accused ofaccepting bribes from the heads ofregional branches of the fund, and phar-maceutical and other commercialcompanies involved in distributingmedication and medical equipmentunder a state-run programme to providefree or subsidised drugs to low-incomepopulation groups. Smerdov’s lawyershave appealed against his arrest and thecourt’s refusal to release him on bail oftwo million rubles ($78,000).

http://en.rian.ru/russia/20070817/72149302.html

Action in Belarus against tobaccoExperts from the Republican Centre forHygiene, Epidemiology and PublicHealth in Belarus have drafted aprogramme against tobacco for 2008 to2010. This is the first time such a

programme has been developed inBelarus.

The document has been distributed to allrelevant ministries and departments. Itsmain goal is to protect present andfuture generations from the health, envi-ronmental and economic consequencesof tobacco smoke. The programme alsoaims to reduce demand for tobaccogoods, and thus related morbidity andpremature mortality. The programmeincludes measures to increase awarenesswithin the population of the dangers ofsmoking, as well as ways to quitsmoking and treat tobacco addiction. Itis hoped that by 2010 that the number ofsmokers aged 15 or under will fall by20%, those aged 16–20 by 10% andthose aged 21–30 by 7%. Experts alsopredict a decrease in the rates of femaleand child passive smoking.

More information at http://www.belta.by/en/news/society?id=171445

Georgia: Street football used to promotechild healthWith the help of the Union of EuropeanFootball Association (UEFA), childrenfrom Georgia, Armenia and Azerbaijanhave been highlighting the role thatsport can play in maintaining a healthylifestyle. UEFA’s partner, Open FunFootball Schools (OFFS), teamed upwith the Georgian Heart Foundation toorganise street football events in theGeorgian capital Tbilisi in May. TheOFFS and the Georgian Heart Feder-ation came together as a result ofUEFA’s support for World Heart Day.

As part of events organised for HeartWeek in Tbilisi, more than one hundredchildren between the ages of eight andtwelve played street football andbasketball around the theme of ‘healthylife through physical activity’. Seven ofthe children who took part have heartconditions or diabetes. Children fromArmenia and Azerbaijan joined localyoungsters in street football matches onsix temporary football grounds. TheMinistry of Public Health and Georgiannon-governmental organisationsworking to combat tobacco and alcoholabuse were involved in other activitiesduring the week.

Open Fun Football Schools areorganised by the Danish Cross CulturesProjects Association (CCPA). Theybenefit more than 30,000 easternEuropean children of all skill levels each

year and are based on a concept of funfootball that downplays competition andis designed to develop confidence andteamwork. “Children and adults acrosseastern Europe love football,” saidAnders Levinsen, director of the CCPA.“We use this shared passion to helpbring together divided communities, andleave behind equipment and training thathelps local football clubs maintain ordevelop activities for children.”

Heart disease and strokes in Georgia,Armenia and Azerbaijan kill morepeople than all other causes combined.“We hope to motivate youngsters to eathealthy diets, remain physically activeand avoid smoking, so that they canavoid the early death and disability thatcauses much pain, suffering and povertyand which is a barrier to our economicgrowth,” said Dr Merab Mamatsashvili,president of the Georgian Heart Foun-dation.

More information athttp://www.uefa.com

Hungary: Investigation into possibleprice fixing in the pharmaceuticalindustryIn June, the Hungarian CompetitionOffice (HCO) began an investigationagainst the Hungarian Chamber of Phar-macists (HCP), the Association of Inno-vative Pharmaceutical Manufacturers,the Hungarian Pharmaceutical Manufac-turers Association, the Generic Medi-cines Manufacturers and DistributorsAssociation, the Vaccine Manufacturersand Distributors Association and thePharmaceutical Wholesalers Association,due to an alleged infringement of theCompetition Act.

A leading Hungarian newspaper,Világgazdaság, reported that HCObegan its investigation in response to acomplaint from the Hungarian TradeAssociation. Világgazdaság quoted PéterSzolnoki, head of the HCO’s cartel unit,who stated that the HCO had alreadyconducted a thorough preliminary inves-tigation regarding the complaint, whichalleged price fixing of non-reimbursedmedicinal products, as well as anunlawful concerted effort by pharmaciesand pharmaceutical companies toprevent the sale of certain over-the-counter medicines outside of pharmacies.

Mr Szolnoki said that preliminary inves-tigations had revealed that the HCP andthe other Associations had communi-


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cated regularly on the current prices ofpharmaceutical products, and that theHCO had therefore decided to launchformal competition supervisoryproceedings, in the form of a full investi-gation. Another Hungarian daily, NapiGazdaság, also reported that the HCOwill allege that this communication wasunnecessary to ensure the safe supply ofmedicinal products.

The Associations are claiming that theywere not in fact involved in the chain ofcommunication because the pharmaceu-tical manufacturers sent their manufac-turer prices to the HCP directly, and notvia the Associations. The HCO maytake up to a year to complete its investi-gation.

More Swedes going abroad for medicaltreatmentThe number of Swedish patients treatedin other EU countries at the expense ofthe Swedish state doubled between 2005and 2006, according to new statisticsfrom the Swedish Social InsuranceAdministration (Försäkringskassan).

The English language daily newspaperThe Local reported that 2,000 peoplehad planned treatment abroad in 2006,compared to only 900 in 2005 and just150 in 2004 when the scheme to fundnon-emergency treatment abroad wasintroduced. Dental treatment was mostpopular followed by treatment formuscle and joint problems. The majorityof individuals were treated in Finland,with Germany the principle destinationfor specialist care. Spain, Portugal andthe Baltic states were the most commondestinations for dentistry. The total costof overseas treatment in 2005 and 2006was 25 million kronor, which can becontrasted with a total health carebudget in excess of 340 billion kronor

The report from Försäkringskassan isavailable in Swedish at http://www.forsakringskassan.se/omfk/styrning/regeringsuppdrag/2007/halso_sjukvard_07

Controversy over new guidance on enti-tlement to sick leave in SwedenIn August new guidelines on the criteriafor sick leave were published by theSwedish National Board of Health andWelfare (Socialstyrelsen). The intentionof the new guidance is that people withmild or insignificant stress-relatedproblems should not be put on sick leavein the first instance. It was feared that

individuals with fatigue syndrome, morecommonly known as burnout, would nolonger be able to be signed off as sick bytheir doctors after the guidance comesinto effect from 1 October. In Swedensome 30,000 people a year are estimatedto have more than two weeks off workdue to exhaustion.

Jörgen Herlofson, who devised thecriteria by which burnout is defined bySweden’s National Board of Health andWelfare, writing in an article in thenewspaper Dagens Nyheter, claimed thatstress-related illnesses were not beingtaken seriously. He said that theNational Board of Health and Welfarehad chosen an ‘anti-humanist’ ideologyand that the main reason was clearly tosave money. “I and many others aredeeply disappointed, worried and suspi-cious,” Herlofson wrote.

However as reported by the Local, theman behind the scheme, Jan Larsson,said that this had been “a gross misinter-pretation. The ambition is to bringforward better and more targeted sickleave practice”. Those with fatiguesyndrome would still in fact qualify forsick leave benefits, but this would beaccompanied by more action from thehealth care system intended to help theseindividuals return to work as quickly aspossible. Social Insurance Minister,Cristina Husmark Pehrsson, also statedthat the new guidelines were one meansof helping more people back to work. “Iwould be sorry if they were misinter-preted. Nobody thinks that a politiciancan get involved in how long a doctorgives people sick leave. That is entirelyup to individual doctors”.

The guidelines have caused controversysince they were released. The SwedishMedical Association (Läkarförbundet)has backed the new rules, while manypatients’ groups have been critical.

Spain: Expert group to consider futureof nursing in the National HealthSystem On 10 July the Ministry of Health andConsumers ordered the establishment ofan expert working group to help begin aconsultation process over the role playedby nurses within the National HealthService (NHS).

This initiative continues a direction ofwork undertaken by the Ministry ofHealth and Consumers which has beenconscious of the importance of the

nursing profession as a fundamentalpillar in the sound functioning of theNHS. The government has alreadyintroduced measures to develop andmake improvements to the nursingprofession through the passing of RoyalDecree 450 in 2005. This focused onspecialities within nursing and approvedthe recognition of new degree standardqualifications as the basis on which toenter these specialities.

The government will thus publish a draftdocument on the role of nursing,intended to be the springboard forsubsequent consultation with all stake-holders. This initial document will bedeveloped by the proposed expertworking group, which itself will behosted within the National Council ofSpecialists in the Health Sciences, amulti-disciplinary body considered mostsuitable for this task.

The work of this expert group marks thebeginning of what is anticipated to be aprofound debate over the role thenursing profession currently occupieswithin the NHS, as well as how it canadapt to future demands. The report willassess the current situation, identify newhealth and social care demands, anddetermine their consequences for thefunctions and skill-mix of the nursingprofession, as well as the knock oneffects for other health care professions.The report is expected to be completedby 15 December, when consultationwith all relevant stakeholders will begin.

In addition to the chair, the expertworking group will have eight members.The Ministry have given assurances thatits composition will be broad in order tobe fully representative. It will includeone representative of the 17Autonomous Communities that makeup Spain, one each from the Ministriesof Health and Consumers andEducation and Science, three from thenursing professions and two from othermedical professions. The importance ofadequate representation, including allfacets of nursing on the working group,has been strongly emphasised by thedecision to appoint a member of theNational Commission on Nursing to thegroup, with a second nurse coming froma care and welfare background and thethird from the world of academia.

More information (in Spanish) athttp://www.msc.es/gabinetePrensa/

Climate change: Europe must adapt Climate change poses a double chal-lenge: Europe must not only make deepcuts in its greenhouse gas emissions butalso take measures to adapt to currentand future climate change, in order tolessen the adverse impacts of globalwarming on people, the economy andthe environment. This is the key message of a Green Paper published bythe European Commission which setsout options for EU action to help theprocess of adaptation to climate changeacross Europe. Adaptation implies taking action to cope with changing climatic conditions, for example byusing scarce water resources more efficiently or ensuring that vulnerablepeople are properly cared for duringheat waves. The Green Paper consulta-tion runs until November and will contribute to future EC proposals.

More information athttp://ec.europa.eu/environment/climat/eccp_impacts.htm

EurLife database of quality of life in-dicatorsThe EurLife database, maintained by theEuropean Foundation for the Improve-ment of Living and Working Condi-tions, and which deals with the objectiveliving conditions and subjective well-being of European citizens, has recentlybeen updated. New indicators have beenadded, as well as data for more recentyears. National coverage has been expanded to include the 27 EU MemberStates and Turkey. The database will beupdated again in 2008 with results fromthe second European Quality of LifeSurvey.

The database can be accessed athttp://www.eurofound.europa.eu/areas/qualityoflife/eurlife/index.php

WHO guide to the essentials inprison healthThis new publication from the WHORegional Office for Europe, edited byLars Møller, Heino Stöver, Ralf Jürgens,Alex Gatherer and Haik Nikogosianoutlines some of the steps prison systems should take to reduce the publichealth risks from compulsory detention

in often unhealthy situations, to care forprisoners in need and to promote thehealth of prisoners and prison staff. Thisrequires that everyone working inprison understand how imprisonmentaffects health, what prisoners' healthneeds are and how evidence-basedhealth services can be provided foreveryone needing treatment, care andprevention in prison. Other essential elements are being aware of and accept-ing internationally recommended standards for prison health; providingprofessional care with the same adherence to professional ethics as inother health services; and, while seeingindividual needs as the central feature ofthe care provided, promoting a whole-prison approach to care and promotingthe health and well-being of people incustody.

The guide is available athttp://www.euro.who.int/document/e90174.pdf

EU to study electronic chips foreHealthIn July the Commission launched a tender to examine the options for usingRadio Frequency Identification (RFID)technology in healthcare, with applica-tions ranging from the identification ofpatients in hospitals to tagging pharma-ceutical products. The main objective ofthe study will be to assess the expectedfeatures of RFID applications in thehealth care market and to build futurescenarios in the field. It is also set toidentify possible obstacles and needs for policy actions or specific research activities on the subject.

More information athttp://ted.europa.eu/udl?uri=TED:NO-TICE:163980-2007:TEXT:EN:HTML

Impact of video and computer gameson child healthThe Swedish National Institute of Public Health has undertaken a system-atic review looking at the effects of playing video and computer games onthe health of children and young people.The review found that there was onlylimited evidence to suggest that playingviolent video and computer games

caused children to choose aggressivetoys. It also did not provide any supportfor a link between video game playingand aggressive feelings, aggressivethoughts or aggressive behaviours, despite all these outcomes having beenwell studied. Furthermore, the availablelongitudinal studies of video game playing and excess weight in childrendid not support a link, while there was,in fact, strong support to suggest thatplaying video and computer games haspositive effects on cognitive abilities.

The report is available athttp://www.fhi.se/upload/ar2007/Rapporter%202007/R200518_video_computer_game.pdf

Windmill 2007: The future of healthcare reform in EnglandIn a new paper from the independenthealth think tank, the Kings Fund, SarahHarvey, Alasdair Liddell and LaurieMcMahon report on the findings of theWindmill 2007 initiative. This is namedafter the 'Rubber Windmill', a simula-tion modelling process developed in1990 to explore how the health servicewas responding to the internal marketbeing developed at the time. The newstudy included a two-day simulation ofa fictional but realistic health economyfrom 2008 to 2011 and extensive discus-sions of the emerging findings with arange of stakeholders. Among the keymessages of the paper is the need for aclear set of rules for competition withinthe NHS to ensure that all players, commissioners, providers, public sectorand private, can plan for the future andthat the emergent market works in theinterests of patients.

The report is available athttp://www.kingsfund.org.uk/publications/kings_fund_publications/windmill_2007.html

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