Eurohealth, Vol 15, No.4, (2009) - World Health Organization · Maria Lluchis reading for a PhD, LSE Health, London School of Economics and Political Science, UK. Angela Mehtais Finances

EurohealthVolume 15 Number 4, 2009RESEARCH • DEBATE • POLICY • NEWS

Wales: policy development for older people • Child and adolescent mental health in EuropePoland: hospital privatisation • Community pharmacy regulation • England: evidence for social care

Zsuzsanna Jakab: building a healthier, safer, fairer and greener Europe

Comparative clinical effectiveness, drug development and regulatory policy

The EU School Fruit scheme: integrating public health into mainstream policy

Periodic health examination:history and critical assessment

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Published by LSE Health and the European Observatory onHealth Systems and Policies, with the financial support ofMerck & Co and the European Observatory on Health Systemsand Policies.

Eurohealth is a quarterly publication that provides a forum forresearchers, experts and policymakers to express their views onhealth policy issues and so contribute to a constructive debateon health policy in Europe.

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Periodic health checks: handle with care

“Periodic health checks and screening are now very popular procedures. A priori they should be effective inreducing the burden of disease and improving wellbeing.Unfortunately the reality seems to be less attractive.” Sowrites Walter Holland in his brief history and critical assessment of periodic health examinations that featuresin this issue of Eurohealth. Such tests may appear attractive to the public and politicians alike; in recentyears there has been an increase in the marketing of whatcan often be quite expensive diagnostic tests. While someperiodic health checks undoubtedly benefit individualswhen used appropriately, Holland cautions us not to forget that they are only of use when accepted treatmentsfor the disease in question are available. Moreover, theycarry well documented risks of side effects, including increasing anxiety, overtreatment and overdiagnosis. Investment in more upstream measures to tackle thecauses of poor health and health inequalities, he suggests,may often be a more prudent course of action.

We are also particularly delighted to feature in Eurohealth an article from the new World Health Organization Regional Director for Europe, ZsuzsannaJakab, who sets out her vision of the way forward for theWHO Regional Office. A number of different measureshighlighted include a Strategic Action Review on addressing the social determinants of health and related inequities, in order to inform the European Health Strategy and build on the work of Commission on theSocial Determinants of Health. Specific challenges to bemet include strengthening the role of the Regional Committee, as well as the need to further develop strong partnerships and joint actions with stakeholders in Europe and beyond who have health mandates or are engaged in actions that have health consequences.

In a packed issue other contributions include our occasional debate series, this time focusing on issuesaround regulation to help minimise bias in respect of theevaluation of new drugs. We also feature two articleslooking at policy implementation: one on mainstreamingpublic health policy at a European level, the other on the development of policy for older people in Wales.

David McDaid EditorSherry Merkur Deputy Editor Philipa Mladovsky Deputy EditorLucia Kossarova Assistant EditorAzusa Sato Assistant Editor

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Contents EurohealthVolume 15 Number 4

Vittorio Bertele’ is Head, RegulatoryPolicies Lab, Mario Negri Institute forPharmacological Research, Milan, Italy.

Frank DeFelice is Director, Health Technology Assessment Policy, Europeand Canada, Merck Sharp and DohmeEurope, Inc, Brussels, Belgium.

Silvio Garattini is Director, RegulatoryPolicies Lab, Mario Negri Institute forPharmacological Research, Milan, Italy.

Walter Holland is Emeritus Professor ofPublic Health Medicine and VisitingProfessor, LSE Health, London Schoolof Economics and Political Science, UK.

Zsuzsanna Jakab is World Health Organization Regional Director for Europe, Copenhagen, Denmark.

Martin Knapp is Professor of SocialPolicy and Director of the NIHR Schoolfor Social Care Research, LondonSchool of Economics and Political Sci-ence, UK.

Maria Lluch is reading for a PhD, LSEHealth, London School of Economicsand Political Science, UK.

Angela Mehta is Finances and Communications Administrator, NIHRSchool of Social Care Research, London School of Economics and Political Science, UK.

Felix Mittermayer is Policy Analyst, DGSANCO/02, European Commission.

Gareth Morgan is Project Manager,National Service Framework for OlderPeople, Llanelli, Wales.

Robert Pederson manages the European Agriculture and Health Consortium, Brussels, Belgium.

Lukas Pfister is Executive Director Public Policy, Europe and Canada,Merck Sharp and Dohme Europe, Inc,Brussels, Belgium.

Dainius Puras is Associate Professor,Institute of Institutional Relations andPolitical Sciences, Vilnius University,Lithuania.

Egle Sumskiene is based at the SocialWork Department, Vilnius University,Lithuania.

Peggy Watson is at the Homerton College, Department of Sociology PPSIS, University of Cambridge, UK.

Snapshots12 Social Care: a new initiative in England to fill evidence gaps

Martin Knapp and Angela Mehta

14 Child and adolescent mental health in Europe. Research on best practiceDainius Puras and Egle Sumskiene

Building a healthier Europe1 Building a healthier, safer, fairer and greener Europe: my vision for the WHO

Regional Office for EuropeZsuzsanna Jakab

Debate: comparative clinical effectiveness4 Comparative clinical effectiveness

Silvio Garattini and Vittorio Bertele’

7 Drug development: a complex and risky but potentially rewarding collaborative processLukas Pfister

10 Reponse to PfisterSilvio Garattini and Vittorio Bertele’

10 Patient health improvement: moving to what is adequate and feasible in assessment of innovative medicines Lukas Pfister and Frank DeFelice

Health policy developments26 Are regulations of community pharmacies in Europe questioning our

pro-competitive policies?Maria Lluch

28 Hospital privatisation in PolandPeggy Watson

Evidence-informed decision making32 “Bandolier” Investigating over-the-counter oral analgesics

37 “Mythbuster” Whole-body screening is an effective way to detect hidden cancers

Public health perspectives16 Periodic Health Examination – A brief history and critical assessment

Walter Holland

21 The EU School Fruit Scheme: integrating public health into mainstream policyFelix Mittermayer and Robert Pederson

23 Policy development and implementation: The National Service Framework forOlder People in WalesGareth Morgan

Monitor39 Publications

40 Web Watch

41 News from around Europe

Eurohealth Vol 15 No 41

BUILDING A HEALTHIER EUROPE

Europe’s public health environment israpidly changing. The avoidable and reme-diable but persistent health divide in theEuropean Region, growing and unfairinequities in health both within andbetween countries in the Region, in con-junction with our changing demographicand social landscape are of greatestconcern. These challenges combined withpandemic (H1N1) 2009 influenza, thegrowing epidemic of non-communicablediseases (NCD), continuing financial crisesand the health impact of climate changedemand new ways of advocating, man-aging and responding for public health atall levels in our globalised world.

I believe that the WHO Regional Officefor Europe has a key role to play inaddressing these challenges, as both aproactive leader and a solid partner whenjoint actions are needed. Importantly, weneed to strengthen our ability to adapteffectively and efficiently to these rapidlychanging environments and take fulladvantage of the collective wisdom, expe-rience and know-how of our vast anddiverse Region – not only for theimproved health of Europe but also forEurope’s contribution to global health.

To this end, shortly after being nominatedby the WHO Regional Committee forEurope in September 2009, I launched aninformal consultation process withEurope’s health community, including a

transition website. The aim of this processhas been to stimulate much needed publichealth discussion, debate and exchange onkey challenges and, most importantly, toinitiate a broadly inclusive process thatprovides an opportunity for Europe’spublic health community to activelyengage in and shape plans and efforts toadapt the Regional Office to our changingEuropean environment.

Through this informal consultationprocess, I elaborated a vision for theRegional Office and posed a series of ques-tions related to leadership, governance,partnership, the Regional Office as a net-worked organisation and priority actionsthat could be taken to make this vision areality. As I now formally assume my roleas Regional Director for Europe, I willcontinue this dialogue as part of WHO’sformal consultation process which willinform and shape a ‘Way Forward’strategy that will be presented and dis-cussed in the Standing Committee of theRegional Committee and then in theRegional Committee in Moscow in Sep-tember 2010. I am pleased to now sharethis vision and some early thoughts onways to get there with the readers of Eurohealth.

Vision statementI see the WHO Regional Office forEurope as a strong, evidence-based centreof public health excellence that earns therespect and support of Member States andother players for our leadership in healthpolicy and public health. I see the RegionalOffice as an organisation whose high–calibre, motivated staff take coordinatedaction with partners to ensure attainmentof the highest possible level of health by all

peoples in our Region and beyond, under-standing and drawing inspiration fromWHO’s Constitution and its definition ofhealth as “a state of complete physical,mental and social well-being and notmerely the absence of disease or infirmity.”I see the WHO Regional Office forEurope as an organisation that:

– is an effective champion of public healthissues and opportunities;

– seriously addresses inequalities andsocial determinants of health, appealingto and engaging with a wide range ofsectors and stakeholders at all levels;

– continuously strengthens the depth andquality of work in and with MemberStates through effective policy dialogueand cooperative action programmes;

– ensures its relevance to all MemberStates and their current and changinghealth needs;

– unites and integrates the Region, actingas a bridge between the different partsof the Region and promoting the prin-ciple of solidarity;

– is there for its Member States wheneverand wherever it is needed, especially intimes of outbreaks or disaster;

– effectively communicates informationand engages its wide and extended net-works to advocate for necessary action;

– anticipates and analyses changes,opportunities and developments with apotential impact on health and helpsMember States to respond accordingly;

– serves as effective secretariat to theRegional Committee and in collabo-ration with Member States turns policy

Building a healthier, safer,fairer and greener Europe: My vision for the WHO Regional Officefor Europe

Zsuzsanna Jakab

Zsuzsanna Jakab is World Health Organ-ization Regional Director for Europe,Copenhagen, Denmark.

decisions and recommendations intoaction;

– innovates and inspires through its tech-nical and policy work and links withresearch communities;

– works in close partnership with others,including: Member States and theirinstitutions, WHO Head Quarters andother regions, United Nations andother international agencies, EuropeanUnion institutions, the European publichealth advocacy and research com-munity, non governmental organis-ations (NGOs), and the private sector;

– is part of, and actively supports, globaldevelopments within WHO, under theleadership of the DG, and also collabo-rates closely with the other WHORegions; and

– promotes a healthy, green and sup-portive working environment for itsstaff.

LeadershipWHO’s constitution provides the moral,inspirational and technical fundamentalsfor leadership in health policy and publichealth. However, to ensure relevance andcontinue to earn and deserve this lead-ership, there is a need for the Office toactively and meticulously address all theactivities listed in the vision above. I seeour leadership as facilitative rather thanprescriptive. Based upon consultativeinputs to date, there appears to be strongsupport for the Office to catalyse andcoordinate the renewal of a common,coherent and comprehensive value-basedEuropean Health Policy which specificallyaddresses current health challenges. Such apolicy would be at the core of our ‘WayForward’ strategy and would provide aframework and roadmap for MemberStates and other partners for:

– addressing health inequities and thesocial determinants of health in theEuropean Region;

– dealing in a systematic and targeted waywith present and emerging publichealth challenges and priorities;

– addressing the impact of major devel-opments that drive societies on health,as well as the contribution of health tothese developments: for example, eco-nomic and fiscal policies, sustainableenergy, environment and climatechange, changes in the demographic andsocial landscape of the EuropeanRegion, science and technology, etc;

– putting health at the centre of devel-opment as a key consideration in allsectoral policies at all levels of Gov-ernment; and

– engaging a wider (or broad) range ofstakeholders.

One of my first decisions after takingOffice in the beginning of February hasbeen to commission, under the chair-manship of Professor Sir Michael Marmot,a Strategic Action Review for addressingsocial determinants of health and relatedinequities in the WHO European Region.The Review will inform the EuropeanHealth Strategy and will build on thefindings and recommendations of theglobal Commission on the Social Determi-nants of Health, the Review of Inequalitiesin England (the Marmot Review), andgather new evidence which reflects the spe-cific realities of all parts of our EuropeanRegion. Importantly, this review willtranslate its findings into policy proposalsand practical guidance for capacitybuilding and implementation.

GovernanceThe WHO Regional Committee (RC)includes Ministers of Health from all 53countries in the Region, as well as repre-sentatives of other UN agencies, the EUand NGOs having official relations withWHO. The RC formulates policies gov-erning matters of an exclusively regionalcharacter, and suggests and approves thecalling of Ministerial conferences and suchadditional work or investigation in healthmatters as in the opinion of the RegionalCommittee would promote the objectiveof the Organization within the Region.The RC is a unique and importantplatform for policy dialogue and decisionsthat shape the work of WHO and publichealth more broadly in the Region. Ibelieve there is a need to strengthen the RCand its Executive Board, the StandingCommittee of the Regional Committee(SCRC), and I am seeking input on waysto make the RC and SCRC more attractiveand effective for our Member States, aswell as other partners and relevant sectors.

Governance – international healthAs shown in the recent Climate Changenegotiations in Copenhagen (COP-15),Europe has an important role to play inglobal health governance and global healthdiplomacy to support global develop-ments. At the same time, the impact ofglobalisation on Europe needs to beexplored further.

PartnershipsOver the past decade, Europe has becomean increasingly complex health envi-ronment, with many new players andchallenges. This changing environment hassignificant implications for the role of theRegional Office. It is critical for publichealth in Europe and beyond that WHOdevelop strong partnerships and jointactions with partners who have healthmandates or are engaged in actions thathave health consequences. These partner-ships must find ways to ensure that theadded value of each partner is maximallyexpressed. By clarifying roles and respon-sibilities, it should be possible to ensure amore coordinated approach and avoidduplication and parallel actions.

The health mandate of the EU has grownand will continue to grow. The mem-bership and geographical basis of the EUhas also grown and is likely to continue togrow. This provides a unique opportunityfor new strategic partnerships betweenWHO and the EU. Other importantpartners include NGOs, the Organisationfor Economic Cooperation and Devel-opment (OECD), UN Agencies, theGlobal Fund and others.

The Regional Office as a networked organisationMy vision is of ‘One WHO’ in Europe,with all its 35 country offices and centresfully integrated as part of one strongnetwork. I see the Regional Office inCopenhagen as providing all strategic corefunctions related to policy, strategy andprogramme development and building onthe work of the centres that produce evi-dence and support implementation andcountry offices which promote these evi-dence–based approaches and adapt them totheir national contexts.

The European Region is diverse, with its53 countries in different stages of devel-opment. This is its beauty, strength andchallenge. WHO should build on Europe’sstrengths and actively engage with the vastwealth of institutional and expertknowledge and experience in MemberStates. At the same time, the RegionalOffice can play an important bridging roleand act to ensure international collabo-ration, as well as encourage and promotebi-lateral collaboration and cooperationwithin the Region.

I believe that evidence-based technical pro-grammes have been and should be thebackbone of the Organization. Theysupport development work at European

Eurohealth Vol 15 No 4 2


level, reflecting the priorities, specificityand diversity of the European Region, aswell as at country level, adapting interven-tions to match the specific needs andresources of each Member State.

We will be looking at whether technicalprogrammes should be focused on selectedpriority topics or ensure coverage of awide range of health expertise. We willlook at how EURO can best catalyse dia-logue and cooperation between MemberStates and link to, engage and utilise thevast health knowledge and experience ofMember States.

Our Country offices are crucial in theWHO architecture. While the offices incountries with substantial need forcountry-specific technical cooperationprogrammes have a clear cut and straight-forward role, the role of the countryoffices in other Member States (forexample, those that joined the EU in 2004and beyond) may need to be re-examinedto find new ways of working. Countryoffices must be useful in delivering theWHO agenda to the Member States theyserve. Their structures and functionsshould be adapted to context-specificneeds, expectations and opportunities.Moreover, WHO has to increase its rele-vance to the EU countries. This requiresbetter understanding of needs, resourcesand priorities and identifying issues forwhich WHO support can add value.

We will review whether EURO shouldhave a country presence in all countries,whether sub-regional arrangements shouldbe considered and if WHO country officescould be joint offices with other partnersand/or international agencies.

Topic-focused, policy, settings-based,NGO/civil society, public health andhealth professional association networkshave been critical in advocating publichealth messages, promoting partnerships,change and innovation. We will be lookingat ways to renew, support and strengthenour networks.

Action prioritiesWhile programme prioritisation hasalways been a balancing act betweenplanning and the need to respond toemergent public health crises and otherexternalities, I believe that the Regionalpriorities of the Office, under the guidanceof the RC, should reflect the main diseaseburden of the Region and its determinants,with the aim of improving the health statusof the European population.

Action priorities for the Office mustinclude:

Non-communicable diseases (NCDs),which now represent 80 % of the diseaseburden in the Region. We need an inte-grated action plan which addresses allrelevant social and health determinants, aswell as the health promotion and diseaseprevention issues, and strong politicalcommitment on alcohol, obesity, physicalactivity, smoking and environment fromthe Regional Committee.

Communicable diseases (CDs), wheredetection of and response to new threats,prevention and control of the old ones(such as HIV, Tuberculosis, Vaccine Pre-ventable Diseases (VPDs), malaria); specialemphasis on Anti-microbial Resistance(AMR) and Health Care Acquired Infec-tions (HCAIs); and assisting MemberStates in International Health Regulation(IHR) implementation and capacitybuilding will be crucial.

Environment and health, where we needto ensure implementation of the commit-ments of past ministerial conferences andidentify new strategic priorities for theyears to come.

Strengthening health systems, where webring added value to the Member Statesand support the prevention aspects ofhealth care systems, as well as the strength-ening of public health functions. Thefurther development of primary healthcare with appropriate emphasis on pre-vention and health promotion is a must.Continued help to Member States torespond to the financial crisis and sup-porting ministries of health to argueeffectively for the macroeconomic impor-tance of health systems is also important.

Training and capacity buildingThe Regional Office, supported by collab-orating centres and network experts, isinvolved in a lot of training and capacitydevelopment across the Region. We arelooking to better define the RegionalOffice’s role in training and capacitybuilding and how it can best takeadvantage of the vast expertise and expe-rience in this domain available in theRegion.

Communications and information systemdevelopment EURO should be a strong and clear voicefor public health, supporting MemberStates in their actions, and should be heardconsistently in the global arena on major

public health issues. Governments must besupported in their handling of complexpublic health issues by providing data, evi-dence, policy options and transfer of goodpractice. Innovative communication andinformation tools should be explored andused more systematically to reach WHO’sdiverse clients such as decision makers,professionals and the public, including vul-nerable populations and young people.EURO must make the best use of availableinformation and communication tech-nology.

In this article I have shared with you myvision for the WHO Regional Office forEurope and some of the issues we are grap-pling with to make it better positioned andcapable of supporting the 53 countries ofthe European Region. These are indeedlandmark times for health, but I know thattogether with Member States, WHO cancraft a strategy and take collective actionthat can affect and improve Europe’shealth. Together we can help build ahealthier, safer, fairer and greener realityacross the WHO European Region andbeyond.



New project on healthservices research prioritysetting

The European Observatory onHealth Systems and Policies is participating in Health Services Research (HSR) Europe, a SupportAction project in the 7th FrameworkProgramme of DG Research.

This project is aimed to identify,evaluate and improve the contribution of HSR to the healthpolicy process both at the nationaland the EU level.

One of the major activities is the organisation of a working confer-ence, on 8–9 April 2010, where theHSR community and decision-makers are meeting to set anagenda for European HSR and tohelp strengthen the research-policy infrastructure Europe wide.

For more information see:www.healthservicesresearch.eu

http://www.healthservicesresearch.eu


DEBATE: COMPARATIVE CLINICAL EFFECTIVENESS

Clinical effectiveness includes the conceptof the benefit-to-risk ratio of a given inter-vention, considered in its real contextwhere, besides its actual effect, subjectiveand environmental factors such as tolera-bility, compliance and cost are all influential.

Clinical effectiveness is always assessed bycomparison. Sometimes it may appear self-evident by historical comparisons: theintroduction of antibiotics, vaccinations,coronary care units, histamine2 receptorsand proton pomp inhibitors clearlyreduced mortality or disability, or the needfor radical surgery.

Other interventions, more often pharma-cological treatments, involve uncertaintyand their effectiveness must be carefullyassessed – this is usually done in ran-domised controlled trials. With time theseclinical research tools have acquiredvarious means aimed at avoiding bias inplanning and conducting the studies and ininterpreting the results. These include theadoption of a parallel control group takingplacebo or, whenever possible, an activecomparator; randomisation, which meansthat chance distributes subjective charac-teristics into comparable groups thus

resolving individual heterogeneity intopopulation homogeneity; and statistics, toadequately power the study and interpretits results as to avoid overlooking anyeffect due to the test treatment (false neg-ative) or unduly attributing it to the effectof chance (false positive).

Even so, there are several biases that maymake comparative studies unreliable oreven impracticable. These come under atleast three headings which will beaddressed here in increasing order ofimportance in terms of responsibility forlimiting knowledge about drugs, theiroptimal use, and their place in therapy inrelation to other treatments.

Methodological biases: the choice ofcomparatorsThe first area of bias lies in the method-ological approach: choice of thepopulation on the basis of inclusion andexclusion criteria, which all too oftenoverlook the needs and interests ofchildren, women and older people; choiceand dosage of the comparator; choice ofthe data analysis strategy – intention-to-treat or drug efficacy criteria. There aremany other methodological options thatcan affect the internal and external validityof comparison. In this article the choice ofcomparator and its dose are important.

The cardiotoxic effect of a cycloxygenase-2 inhibitor, rofecoxib, appeared similar to

that of non-steroidal anti-inflammatorydrugs when compared with diclofenac, butgreater when naproxen was the com-parator.1 The asserted superiority ofmycophenolate mofetil over azathioprine2

was not confirmed when concomitanttreatment with cyclosporin microemulsionachieved better therapeutic levels than theold formulation.3

The claimed superiority of atypical orsecond-generation antipsychotic drugsover older drugs in this class no longerholds true in the light of a meta-analysis of150 randomised trials.4 This analysis foundthat as a group the second-generationantipsychotics were no more effective, didnot improve specific symptoms, and hadno clearly different side-effect profilesfrom the first-generation drugs. They werealso less cost-effective. Therefore the‘atypical’ antipsychotics are now regardedas an ‘invention only’, manipulated by thedrug industry for marketing purposes.5

The clinical development of atypicalantipsychotics is affected by several biases,all favouring second-generation drugs.These include comparing the second-gen-eration antipsychotic with a high-potencyfirst-generation one, likely to involve ahigh rate of extrapyramidal side effects: ofthe 150 trials in the meta-analysis, 95 com-pared the second-generation antipsychoticwith haloperidol. Comparison with amedium-potency first-generation anti-

Debate Comparative clinical effectiveness

Silvio Garattini is Director and VittorioBertele’ Head of the Regulatory PoliciesLab, Mario Negri Institute for Pharmacological Research, Milan. Email: [email protected]


Summary: Comparative studies can be done but bias may make them unreliable or even impracticable. This paper discusses three possible areas of bias. The first regards the methodologicalapproach: many methodological options may affect the internal and external validity of a compari-son. The second regards the study hypothesis, which sometimes is not relevant for patients and over-looks their needs. The third area is the public domain of drug policy. Often products whose absoluteand relative clinical value is uncertain are allowed onto the market on the basis of data producedby the manufacturers themselves. Political and regulatory authorities should stimulate industrialresearch to comply with patients’ and national health services’ needs and could contemplate fund-ing independent research addressing important questions that do not attract private investment.

Key words: Drug regulation, independent clinical research, controlled clinical trials, active control,non-inferiority trials.


psychotic was avoided, because these arelikely to be just as effective as the second-generation drug, and less likely thanhaloperidol to induce Parkinsonism.

Sometimes industry-sponsored studiesselect comparators that are not the bestavailable treatments and endpoints thatmagnify their deficiencies, thus facilitatingthe better outcome of the experimentaldrug. The ALLHAT study,6 which com-pared chlorthalidone, doxazosin, lisinopril,and amlodipine for first-line anti-hypertensive therapy, showed that low-dose diuretics were superior in preventingcardiovascular events. Subsequentindustry- sponsored trials neverthelessadopted atenolol as the comparator eventhough beta-blockers are known toprovide a mortality benefit in patients withcoronary heart disease (atenolol being theleast effective7) but not to preventcoronary heart disease in patients withhigh blood pressure.8 Moreover, as Psatyand colleagues noted,8 since calciumchannel blockers are associated with anincreased risk of heart failure,6 curiouslyenough, heart failure was excluded fromthe composite outcome measure in trialswhere these were the test drugs,9,10 butwas included when a calcium channelblocker, amlodipine, was the comparator.11

Strategic biases: irrelevant questions forpatientsThe second area of bias is the studyhypothesis, which should address clinicalquestions relevant for patients, meaninglooking for answers to unmet needs.Testing the superiority of a new productover placebo when active comparators areavailable, or its non-inferiority to activedrugs, aims at satisfying marketing pur-poses, not patients’ needs.

The MATCH study randomised patientswith a recent transient ischemic attack(TIA) or ischemic stroke to clopidogrelplus aspirin compared with clopidogrelplus placebo. The study showed that anybenefit of the combination over clopi-dogrel alone in reducing the risk ofischemic events after a TIA or stroke wassmall. Testing aspirin as an add-on toclopidogrel took it for granted that thelatter was the first-choice treatment inthese patients. This assumption was poorlyevidence-based. It relied on the results ofthe CAPRIE study12 which had shownmarginal statistical superiority of clopi-dogrel over aspirin: five cardiovascularevents avoided yearly every 1,000 patientstreated. Besides being small, the benefit

was not evenly distributed among groupsat risk: patients with peripheral vasculardisease benefited, those with coronary orcerebrovascular disease did not. Thealleged advantage also reflected theselected primary outcome measure: statis-tical significance disappeared in secondarycombined endpoints, particularlyincluding major amputation, the mostobvious outcome measure for peripheralartery disease. The CURE trial addressedthe main question for patients and nationalhealth services.13 It showed that addingclopidogrel to aspirin had an acceptablesafety profile in patients with acutecoronary syndromes and was moreeffective than aspirin alone.

The questions that are important forpatients and public health services arethose that also consider the feasibility andaffordability of experimental interventionsand test their comparative cost-effectiveness where possible. The trialswith clopidrogrel should have taken intoconsideration the fact that that aspirin wasthe best known, most widely used andleast expensive anti-platelet drug.

Sometimes the hypothesis, though inspiredby marketing aims, is of public healthinterest too. However, the methodologicalapproach mostly addresses industrialinterests. For instance, non-inferioritytrials are only designed to prove that a newdrug is no worse than a comparatoralready on the market. From the industry’spoint of view these studies are preferablesince it is easier to show non-inferioritythan superiority and less risky too: failureto prove superiority may damage aproduct and a company’s image whereasproof of non-inferiority ensures a place onthe market. However, these studies onlyproduce ‘me-too’ drugs with no identi-fiable added value and no real place intherapy.

It is also worth recalling that non-inferi-ority is defined as a kind of similaritywithin a limit which includes a degree ofinferiority that is believed to be tolerable.A test drug that has been proved non-inferior may actually be less effective orless safe than the comparator, but not somuch as to be recognised as such. Non-inferiority trials allow an excess of adverseevents associated with the test treatmentand do not consider them enough to signala difference from the comparator.

The non-inferiority approach can produceparadoxical situations like the PRoFESSStudy.14 Assuming that clopidogrel

avoided about thirty (at least ten) strokesevery 1,000 patients treated, the non-infe-riority hypothesis of this study consideredit acceptable if aspirin plus extended-release dipyridamole (ASA–ERDP)preserved at least half the effect of clopi-dogrel. This allows at least five morestrokes (actually 94–95 instead of the 88per 1,000 patients reported with clopi-dogrel, according to the non-inferioritymargin set at the odds ratio of 1.075),meaning 50 more strokes in the 10,000patients randomised to ASA–ERDP. Thisconfirms that a non-inferiority hypothesisdoes not address the interests of patientswho would hardly have agreed to partic-ipate if they had been aware of thisprospect.15 Moreover, though the clinicaloutcomes in the two treatment groupswere super imposable, the trial could notprove the non-inferiority of the testtreatment. Failure to prove non-inferiorityof a treatment basically as effective as thestandard shows that non-inferiority trialsmay not even meet their obvious com-mercial aims of reviving an old drug,providing an extended indication and anupdated price, while the newer clopidogrelwas losing its patent protection.

Another approach that does not fully meetpatients’ and National Health Service(NHS) interests is known as the ‘add-on’.Sometimes a new drug is added to thecurrent treatment in the experimental armand compared with placebo given on topof the current treatment in the controlgroup. Comparing one treatment with twoseems an uneven match, since it may wellbe easier for the new drug combined withthe standard treatment to perform betterthan the latter alone. Moreover, thisapproach does not provide adequate infor-mation on how the test drug added on topof ongoing therapies fares in comparisonwith other treatments. This would only bepossible if two active treatments wereused, as either an alternative or an add-onto current unsatisfactory therapies. In add-on studies placebo should only be allowedif no combinations of effective drugs canbe proposed for comparison.16

The alleged reason for selecting the add-onapproach is the need to test remedies forpoor responders to current treatments.However, if the current treatment is defi-nitely not effective, it should not becontinued in either group, as it would beuseless and therefore unethical. If it is partially effective, adding placebo in onearm but an active drug in the other wouldbe unethical too.



Regulatory biases: no added value requiredThe third area is the public domain of drugpolicy. Pharmaceutical legislation requirescompanies seeking marketing authori-sation for new products only to providedata demonstrating their good manufac-turing quality, lack of toxicity, and clinicalefficacy.17 These product features aremeant to stand on their own, with no needfor comparison with drugs already on themarket. These rules allow products ontothe market whose absolute and respectiveclinical value is uncertain.18,19 They alsofoster overuse of trials against placebo.

Even when new drugs are compared withexisting treatments, trials often seek toshow non-inferiority rather than superi-ority. This implies that newly approveddrugs might be less active or safe thanthose in current clinical use.15 In addition,efficacy is often measured on the basis ofsoft clinical endpoints or surrogatemarkers of efficacy.19 Finally, the docu-mentation on which the marketingauthorisation application is judged ismainly produced by the manufacturers,which not only select the clinical area ofintervention, choosing the least risky andmost profitable, but also the kind of trial,aims and approach, the most suitableinvestigators, and whether and how toanalyse and publish the results.

Health authorities need to stimulateindustry research to comply with patients’and NHS services, besides their marketinggoals, however legitimate these may be.EU legislation should require the docu-mentation accompanying marketingauthorisation applications to includeclinical trials designed and conducted byindependent institutions and cooperativegroups. In addition public institutionscould fund independent researchaddressing clinical questions that are not ofinterest to the pharmaceutical industrywhich do not attract investment.

In Europe there are no real incentives forindependent clinical research, albeit with afew exceptions, as in Italy. In 2004 theItalian Parliament passed a law requiringpharmaceutical companies to pay a feeequivalent to 5% of all their promotionalexpenses, except salaries. This money is tobe utilised by the Italian Agency for Drugs(AIFA) to support independent clinicalresearch in three main areas: orphan drugsfor rare diseases, head-to-head compar-isons of drugs with similar indications andoutcome studies with particular reference

to pharmacovigilance. The results shouldhelp improve NHS pharmaceutical policyand reinforce decisions on drug reim-bursement.

A call for proposals indicates the topics ofinterest each year. Letters of intent arescreened by AIFA to identify a list ofprojects then evaluated by internationalstudy sections. The third call was con-cluded in 2008. Thus far 151 projects havebeen approved with a budget of €78million. This is a significant amount ofmoney because under this law pharmaceu-tical products, insurance and fees for theethical committees are all paid by theNHS. The Italian initiative may offer amodel that can be extended to other coun-tries or the European Union as a whole. Ifthis happens the number of independentclinical trials may build up to become a sig-nificant counterpart to industriallysupported studies.

ACKNOWLEDGMENTS: We are grateful toJudith Baggott for editorial revision.

REFERENCES

1. Psaty BM, Weiss NS. NSAID trials andthe choice of comparators–questions ofpublic health importance. New EnglandJournal of Medicine 2007;356:328–30.

2. Fulton B, Markham A. Mycophenolatemofetil. A review of its pharmacodynamicand pharmacokinetic properties and clinical efficacy in renal transplantation.Drugs 1996;51:278–98.

3. Remuzzi G et al. Mycophenolate mofetilversus azathioprine for prevention of acuterejection in renal transplantation (MYSS): arandomised trial. Lancet 2004;364:503–12.

4. Leucht S et al. Second-generation versusfirst-generation antipsychotic drugs forschizophrenia: a meta-analysis. Lancet2009;373:31–41.

5. Tyrer P, Kendall T. The spurious advanceof antipsychotic drug therapy. Lancet2009;373:4–5.

6. ALLHAT Group. Major outcomes inhigh-risk hypertensive patients randomisedto angiotensin converting enzyme inhibitoror calcium-channel blocker vs. diuretic: theAntihypertensive and Lipid-LoweringTreatment to Prevent Heart Attack Trial(ALLHAT). Journal of the American Medical Association 2002;288:2981–97.

7. Freemantle N et al. Beta-blockade aftermyocardial infarction: systematic reviewand meta-regression analysis. British Medical Journal 1999;318:1730–37.

8. Psaty BM, Weiss NS, Furberg CD.

Recent Trials in Hypertension. CompellingScience or Commercial Speech? Journal ofthe American Medical Association2006;295:1704–6.

9. Pepine CJ et al. A calcium antagonist vs.a non-calcium antagonist hypertensiontreatment strategy for patients with coro-nary artery disease: INVEST: a randomisedcontrolled trial. Journal of the AmericanMedical Association 2003;290:2805–16.

10. Dahlof B et al. Prevention of cardiovas-cular events with an antihypertensive regi-men of amlodipine adding perindopril asrequired vs. atenolol adding bendroflume-thiazide as required in the ASCOT-BPLA:a multicentre randomised controlled trial.Lancet 2005;366:895–906.

11. Julius S et al. Outcomes in hypertensivepatients at high cardiovascular risk treatedwith regimens based on valsartan or amlodipine: the VALUE randomised trial.Lancet 2004;363:2022–31.

12. CAPRIE Steering Committee. A randomised, blinded trial of Clopidogrelversus Aspirin in Patients at Risk of Ischemic Events (CAPRIE). Lancet1996;348:1329–39.

13. Yusuf S et al. Effects of clopidogrel inaddition to aspirin in patients with acutecoronary syndromes without ST-segmentelevation. New England Journal of Medicine 2001;345:494–502.

14. Sacco RL et al. 1. Aspirin and ex-tended-release dipyridamole versus clopi-dogrel for recurrent stroke. New EnglandJournal of Medicine 2008;359:1238–51.

15. Garattini S, Bertele’ V. Non-inferioritytrials are unethical because they disregardpatients’ interests. Lancet2007;370:1875–77.

16. Ottolenghi L, Bertele’ V, Garattini S.Limits of add-on trials: antirheumaticdrugs. European Journal of Clinical Pharmacology 2009;65:33–41.

17. Regulation (EC) No. 726/2004, European Parliament and Council of 31March 2004. Community procedures forthe authorisation and supervision of me-dicinal products for human and veterinaryuse and establishing a European MedicinesAgency. Official Journal of the EuropeanUnion 2004;L136/(30 April):1–33).

18. Joppi R, Bertele’ V, Garattini S. Disappointing biotech. British MedicalJournal 2005;331:895–97.

19. Apolone G et al. Ten years of marketing approvals of anticancer drugs inEurope: regulatory policy and guidancedocuments need to find a balance betweendifferent pressures. British Journal of Cancer 2005;93:504–9.





In this issue of Eurohealth1 in their paperon comparative clinical effectiveness,Garattini and Bertele’ question the validityand aptness of clinical studies performedor sponsored by pharmaceutical com-panies. This view is based ongeneralisations and selective citing of theliterature, while failing to appreciate someof the immense challenges facing devel-opment of new medicines.

Throughout the twentieth century, scien-tific advances provided for thedevelopment of new medicines both totreat conditions which were previouslyuntreatable and to improve disease man-agement. This progress was accompaniedby increasingly rigorous standards ofproduct efficacy, safety and quality. Theinnovative pharmaceutical industry wasactively involved in the development,implementation, and promotion of thesestandards. Similarly, industry has been astrong supporter of evidence-based med-icine (EBM) and has structuredpromotional activities in the context oftreatment outcomes. Numerous protocols

and guidelines for patient management,developed by independent professionalconsensus teams, provide essential supportto physicians in navigating availabletreatment options for their patients.

More recently, payers have focused on therelative effectiveness of medicines in termsof their comparative value for money. TheEuropean High Level PharmaceuticalForum provided a working definition ofrelative effectiveness as the extent to whichan intervention does more good than harmcompared to one or more interventionalternatives for achieving the desiredresults, when provided under the usual cir-cumstances of health care practice.2 Thelast two decades have seen the estab-lishment of national health technologyassessment (HTA) agencies, whose task isthe appraisal of medical therapies andinterventions for public funding (and insome cases pricing) purposes.

Research and developmentThe process of developing drugs from thefirst idea through to regulatory approval islong, complex, resource-intensive and isfull of risk with return on investmentuncertain and often delayed. Uncertaintycontinues post-approval since pharma-covigilance concerns may result inwithdrawal of a new medicine at any stage

of its life cycle. It is only the commerciallaboratories with their capacity andresource to undertake such high-riskinvestment that can take forward theapplied research and development from apromising idea to a successful medicine.

The drug development process is generallyincremental. The choice of therapeutic areais often driven by a company’s prior expe-rience in that area, but industry researchactivity also focuses on those areas whichare of major interest to health authorities,the medical community and patients alike.Neurodegenerative disorders and cancerare clear leaders in the pipeline of thelargest pharmaceutical manufacturers.3

The sharing of knowledge within thewider scientific community concerningbasic scientific research and new tech-nology means that pharmaceutical researchlaboratories may be working in parallel onnew chemical entities with similar mecha-nisms of action. In the seventies, theaverage time between the approval of thefirst-in-class product and the next wasabout eight years. This gap decreased toless than two years in the late nineties.4 Itis not unusual for first market entrantsfrom a new class of drug to undergo regu-latory approval concurrently. Such robustdevelopment activities are good forpatients since identical substances may

Debate: Drug development: a complex and risky butpotentially rewarding collaborative process

Lukas Pfister

Lukas Pfister is Executive Director PublicPolicy, Europe and Canada, MSD(Merck Sharp and Dohme) Europe, Inc,Brussels, Belgium.

Summary: Clinical research standards evolve in line with new knowledge and experience. Research and development is focused on current health challenges and is increasingly outcome and health gain oriented. New regulations ensure transparency, elimination of bias and that under-served yet complex populations are included in clinical studies while industry is commensurately rewarded. Clinical studies performed for regulatory approval purposes should remain the responsibility of the pharmaceutical industry and continue to be grounded in collabora-tion with clinical investigators and the public authorities. There is no basis for introduction of a relative effectiveness barrier at the regulatory approval stage. There is no evidence that a tax on innovator companies will provide an efficient system of funding productive independent studies.

Key Words: Drug regulatory policy; clinical trial standards, approval and monitoring; clinical trials in complex populations; relative effectiveness.

affect patient subgroups differently due togenetics, age, co-morbidities, multipledrug treatment, and even subjective per-sonal preferences. Within one class(defined by the mechanism of action), anddepending on the end-points, certain dif-ferences in adverse events and efficacy maybe expected.

In some cases, later entrants in a class wereultimately preferred to the first-in-class.Indeed, as long as twenty years ago, half ofthe drugs on the WHO Essential DrugsList were compounds introduced subse-quent to the first in a therapeutic class.5

While clinical studies in the drug devel-opment period are sufficient for regulatorypurposes, it is the information arising fromtheir everyday use which provides for thebuild-up of their reputation and this can beseen in the generic companies’ choice ofproducts for manufacture when the drugpatent expires. Application of the term‘me-too’ to medicines which are the resultof simultaneous research often greatlyunderestimates the enormous challengesand complexity of the underlying researchconducted and fails to recognise the inten-sified competition between innovators.The appearance of more than one productin the same class provides for choice basedupon the individual patient’s circum-stances. Choice between innovativeproducts also ensures competitionbetween research-based companies and hasa role in modifying product launch price.Moreover, the fundamental principles of amarket-driven economy underscore theinevitability of such simultaneousappearance of multiple products.

Clinical studiesClinical studies are highly regulated andincreasingly so. The provisions of the EUClinical Trials Directive6 ensure thatsponsors and others involved in clinicalresearch apply the standards of goodclinical practice (GCP) rigorously whendesigning, conducting, recording andreporting clinical trials. Compliance withthese standards provides for credibility ofstudy results. Clinical study protocolswhich describe the objectives, design,methodology, inclusion and exclusion cri-teria, statistical considerations andorganisation of a trial, must be submittedfor approval to independent ethics com-mittees and competent national authorities(usually the Regulatory Agency or Min-istry of Health). This also takes intoaccount the relevance of the trialhypothesis, its design, the suitability of theinvestigative team, the investigators

brochure (a compilation of relevant dataon the product under study), and subjectrecruitment arrangements. Trials may onlycommence once ethics and regulatoryapprovals have been secured. Indeed,ethical committees have the power to rejecta clinical trial. A clinical trial may only beundertaken if risks and inconvenienceshave been weighed against the anticipatedbenefits for the individual trial subjects andfuture patients. Regulatory agenciesunderstand the complexities and chal-lenges associated with comparative studies,and take these into consideration whenapproving treatments.

Since many trials have a multi-nationalscope, applications for approval must besubmitted in every Member State con-cerned. Relevant information about thetrial must be entered into the Europeandatabase accessible to the Commission andto the competent authorities of MemberStates. Appropriately qualified and trainedinspectors are appointed by competentauthorities to verify compliance with GCPaccording to set procedures.

The competent authorities also have thepower to require a comparison to becarried out and to suggest a placebo or aspecific comparator. In Europe, it is morecommon to use a standard existingtreatment, although the multi-nationalcharacter of clinical trials means that thecomparator may not always be the mostcommonly used treatment in all partici-pating countries. A review of productsauthorised in the EU between 1999 and2005 showed that 71% of studies usedactive standard treatment as comparatorand 81% of new medicinal products hadbeen tested against active standardtreatment in at least one trial.7

Non-inferiority trials have a role to play asthey satisfy the regulatory requirementsfor safety, efficacy and quality. Moreover,they leverage upon the long term expe-rience and clinical trial data of comparatorproducts. Real life use of the medicine overthe longer term and phase IV studies thenallow for the evaluation of its place indisease management. Trials to evaluatesuperiority are sometimes not practical –they may require sample sizes that areimpractical – and superiority in one aspect(such as one measure of efficacy) may notbe the goal; sometimes the goal is toimprove the safety profile while main-taining efficacy, for example.

Different strategies may be adoptedranging from studying the target popu-

lation as a whole, the largest group ofpotential beneficiaries, or a special sub-population first. Studies in populationswith significant co-morbidities and mul-tiple drug treatment are more complex,may take longer, have recruitment chal-lenges and require greater resources. Initialtrials in simple populations may allowfaster completion of studies and regulatoryapproval and earlier availability as atreatment option. Later studies may thenlook at special sub-populations to ensurethat the benefits of treatment may beaccessible to patients who would oth-erwise be disadvantaged.

Until recently, medicines used in childrenlacked adequate information on efficacyand safety. That unfavourable situation hasalready changed dramatically. Theenactment of the Paediatric Regulation inthe EU8 has meant that since July 2008 allnew applications for marketing authori-sation have had to include results of studiesin a paediatric population conductedaccording to an approved Paediatric Inves-tigation Plan unless a waiver or deferral hasbeen obtained. Similarly, since January2009, applications for additional indica-tions, formulations or routes ofadministration for medicines which arealready approved must also conform tothis requirement.

Standards for inclusion for older patientsare provided by the International Con-ference on Harmonisation of TechnicalRequirements for Registration of Pharma-ceutical for Human Use (ICH)Guidelines.9 In 2006 a report for theEuropean Commission on the adequacy ofthe guidance of the European MedicinesAgency10 found overall reasonable com-pliance with the ICH guidelines and withdisease related efficacy guidelines. Theneed for some revision of the guidelinesresulted in an ICH concept paper inOctober 2008 which set out those elementswhich were essential to ensure that clinicaltrials were relevant to the elderly popu-lation. Additional issues for discussionprior to trial approval would include thenumber and age distribution of expectedold, particularly very old participants,appropriate characterisation of safety inthis population which could be obtainedpost-marketing, specific elements for eval-uation of risks and benefits, includingconcomitant co-morbidities and therapies,discussion and justification of specific agerelated end-points (elderly-relevant out-comes), and defining the usefulness ofspecific pharmacokinetic studies.11



Public policy and medicinesExtensive regulation of the manufactureand licensing of medicinal products is jus-tified by the harm that could arise fromunregulated access of medicines. The legis-lators of the European Union haveadopted the policy position that marketingauthorisations based upon safety, efficacy,and quality are sufficient to ensure patientbenefit and safety, without the need for theintroduction of additional barriers tomarket entry, which would delay patientaccess to new medicines significantly.

Since access to medicines in the publichealth systems in Europe is largely basedupon reimbursement from public funds,the payer interest is safeguarded becauseadequate prescribing occurs only whenreimbursement authorities decide uponcoverage. Increasingly, the effective valueof a new medicine to the payer is deter-mined by HTA. The innovative industrysupports the concept of HTA, providing itis performed correctly, used for the rightpurposes and not limited to drug versusdrug comparisons. Furthermore, treatmentguidelines and recommendationsdeveloped by professional societies play aleading role in disease management.However, there is a significant lag beforenew medicines appear in the guidelines,during which their usefulness comparedwith products available earlier is oftenestablished from results of phase IVstudies.

The generation of efficacy, safety andquality data is a necessary part of thedevelopment of a proprietary new med-icine and should be performed by theinnovator company as the prospectiveholder of the marketing authorisation.Repetition of such studies by anotherparty would not be justified for economicand ethical reasons. Nonetheless, gener-ation of regulatory data is a collaborativeprocess between research laboratory sci-entists and the clinical investigators andtheir institutions. This is a transparentprocess that is open to ethics committeeand competent authority review andsubject to “live” inspection throughout thetrial. Casting doubt on the credibility ofthese data is to cast doubt on the credi-bility of all parties. Additionaltransparency arises from clinical study reg-istries with online public access(www.clinicaltrials.gov and www.clinicalstudyresults.org) which provideinformation on ongoing studies as well ason study results.

Hopes in significant drug development ini-

tiatives by the state instead of the privatesector have continuously been disap-pointed, be it in market economies (wherethe governments created the conditions forprivate sector innovation to flourish), or inthe former state controlled economies ofCentral and Eastern Europe (where vir-tually no innovative products weredeveloped). Instead, competitive researchwithin the private sector has been a keydriver for innovators to make enormousinvestments, shouldering the tremendousrisk associated therewith and bearing thehigh development costs, particularly thoseof phase III clinical studies, the mostexpensive part of research and devel-opment.

Public authorities did not themselvesundertake development of drugs in under-served populations such as those withorphan disease, but what they have done isto encourage commercial entities todevelop orphan drugs by providing incen-tives including a two year extension ofregulatory data protection (i.e. genericmanufacturers may generate their owndata but the original innovator company’sdata cannot be referred to for regulatorypurposes).12 Incentives were also providedto encourage paediatric studies throughextension of regulatory data protectionand Supplementary Protection Certificateterm.

Disincentives against innovative researchactivities such as putting a levy on inno-vator companies (e.g. asking a payment ofa portion of profits into a research fund)must be strongly cautioned against, as theymay force companies to fund research oftheir competitors. Apart from the risk ofnot producing the intended effect, theconcern of regulating in a discriminatorymanner against one particular sector of theeconomy should not be taken lightly.

ConclusionEvaluation of current practices is welcomesince this can draw attention to the need toamend future practices. With hindsight, itis easy to say that former trials should havebeen designed differently. However,whenever unrecognised forms of bias areidentified, they are successively eliminatedfrom new study designs. The currentmodel of the regulatory approval processis collaborative rather than adversarial withimprovement in clinical trial design arrivedat by discussion with the authorities. Iden-tification or emergence of new needs isaccompanied by the enactment of new reg-ulations in a process that allows

stakeholder involvement. The new provi-sions are reflected in training programmesfor those in the research community.

The suggestion that industry sponsors andinvestigators manipulate data constitutes asimplistic generalisation and is grosslyunfair to the thousands of scientists whodevote their lives to the development ofnew medicines. Indeed, companies andindustry associations have developed andimplemented strict ethical codes ofconduct which are sometimes morestringent than state regulations.

Efficient use of public funds is essential toensure the maximisation of health gains.Stakeholders have a common goal inensuring progress so that disease can beeliminated or limited.

REFERENCES

1. Garattini S, Bertele V. Comparative clini-cal effectiveness. Eurohealth2009;15(4):4–6.

2. Core principles on relative effectiveness.High Level Pharmaceutical Forum. Avail-able at www.ec.europa.eu/pharmaforum/docs/rea_principles_en.pdf

3. DiMasi JA. The Economics of New DrugDevelopment: Costs, Risks, and Returns.Tufts Center for the Study of Drug Devel-opment Tufts University. The New Eng-land Drug Metabolism Group SpringMeeting Cambridge, MA, 12 March 2008.Available at www.nedmdg.org/docs/2008/joseph-dimasi-spring-2008.ppt

4. DiMasi JA, Paquette C. The economicsof follow-on drug development. Trends inentry rate and the timing of development.Pharmacoeconomics 2004;22(suppl 2):1–14.

5. Wastila L, Elcickas M, Lasagna L. TheWHO essential drugs list. The significanceof me-too and follow-on research. Journalof Clinical Research and Drug Development 1989;3:105–15.

6. Directive 2001/20/EC, European Parliament and Council of 4 April 2001.Approximation of laws, regulations andadministrative provisions of the MemberStates relating to the implementation ofgood clinical practice in the conduct ofclinical trials on medicinal products for human use. Official Journal of the European Union 2001; 1 May:L121/34–44.

7. van Luijn JCF, van Loenen AC, Gribnau FWJ, Leufkens HGM. Choice ofcomparator in active control trials of newdrugs. Annals of Pharmacotherapy2008;42(11):1605–12.

8. Regulation (EC) No 1901/2006, Euro-



http://www.clinicaltrials.gov

www.clinicalstudyresults.org

http://www.ec.europa.eu/pharmaforum/docs/rea_principles_en.pdf

http://www.nedmdg.org/docs/2008/joseph-dimasi-spring-2008.ppt

www.clinicalstudyresults.org

pean Parliament and Council of 12 Decem-ber 2006. Medicinal products for paediatricuse and amending Regulation (EEC) No1768/92, Directive 2001/20/EC, Directive2001/83/EC and Regulation (EC) No726/2004. Official Journal of the EuropeanUnion 2006; 27 December: L378/1–19.

9. ICH Tripartite Guideline. Studies inSupport of Special Populations: Geriatrics.Geneva: International Conference on Harmonisation of Technical Requirementsfor Registration of Pharmaceuticals forHuman Use, 1993. Available atwww.ich.org/LOB/media/MEDIA483.pdf

10. European Medicines Agency. Adequacyof Guidance on the Elderly Regarding Medicinal Products for Human Use. London: EMA, 14 December 2006. Avail-able at www.emea.europa.eu/pdf/human/opiniongen/49892006eu.pdf

11. Final Concept Paper E7(R1): Studies inSupport of Special Populations: Geriatrics(Revision of the ICH E7 Guideline)Geneva: International Conference on Harmonisation of Technical Requirementsfor Registration of Pharmaceuticals forHuman Use, 2008. Available atwww.ich.org/LOB/media/MEDIA4930.pdf

12. Regulation (EC) No 141/2000, European Parliament and Council of 16 December 1999. Orphan medicinalproducts. Official Journal of the EuropeanUnion 2000; 22 January: L18/1–5.



Debatereponse to Pfister


Debate patient health improvement: moving to what is adequateand feasible in assessment of innovative medicines

Lukas Pfister and Frank DeFelice

It is impossible to tackle all the argumentsraised in this limited space. We shall onlymake a few points. There is no need forindustry to manipulate data: it is enough toselect targets and approaches suited to itslegitimate commercial aims according tothe current rules. The criteria of intrinsicquality, safety and efficacy on which mar-keting authorisations are based may ensurepatients’ benefit and safety, but not neces-sarily their best possible benefit and safety.This is because it is legitimate to compare anew product with placebo or with the mostsuitable comparator(s) to highlight itsclinical merits, or to look for non-inferi-ority compared to the appropriatecomparator, and so on. The risk-benefitprofiles of newer and available productsare deliberately not compared since thedefinition of later entrants’ place-in-therapy might limit their place in themarket. Evaluation of a drug’s clinicalvalue cannot be left to post-marketingeveryday use; experience outside a con-trolled setting cannot replace evidence as abasis for a new drug’s reputation. Later

entrants are usually preferred to olderproducts not because of their proven betterefficacy or safety but thanks to moreintense advertising.1 Moreover, off-labeluse of drugs is repeatedly promoted toboost sales.2 If not even inappropriate indi-cations are available, bizarre diseases are‘invented’ just to find a market forproducts with no real place-in-therapy.3

All this makes commercial interests prevailover those of public health.

REFERENCES

1. Day RO, Williams KM. Open-label ex-tension studies: do they provide meaning-ful information on the safety of new drugs?Drug Safety 2007;30:93–105.

2. Hopkins Tanne J. Pfizer pays record finefor off-label promotion of four drugs.British Medical Journal 2009;339:3657.

3. Moynihan R, Heath I, Henry D. Sellingsickness: The pharmaceutical industry anddisease-mongering. British Medical Journal2002;324:886–91.

Pharmaceutical innovation, in the form ofeither a ‘breakthrough medication’ or anincremental enhancement, has broughtimprovements to patient health and qualityof life.

The goal of health care delivery should bevalue for patients, not containing costs.1,2

Examined in the context of overall health

system spending, pharmaceutical expendi-tures are among the most measured forvalue by public payers. The processes formarketing authorisation approval, thereview of clinical and cost-effectiveness,and the consideration of budget impact forpublic plan reimbursement, are among themost rigorous and evidence-based acrosspublic health care expenditures. In additionto thorough pre-authorisation and pre-reimbursement reviews, ongoing patientimpact of medication use is measured viaindicators, including surrogate markerssuch as HbA1c for long-term bloodglucose control for patients with dia-betes.1,2

Surely, on the road to the ‘best possiblebenefit’, which Garratini and Bertele’ andall of us in society aspire to, we can makeimprovements to patient health and qualityof life, be it via enhanced clinical impact,improved side-effect profiles, and bettertolerance and dosing?

Instead of an ideological simplification ofinterests as conveyed by the authors, thedebate should be focused on how to ensurepatients have timely access to needed,appropriate innovative medications. HadHIV/AIDS patients been forced to awaittreatment at the time of introduction of thepromising early AIDS medication pending

Lukas Pfister is Executive Director PublicPolicy and Frank DeFelice Director,Health Technology Assessment Policy,Europe and Canada, MSD (Merck Sharpand Dohme) Europe, Inc, Brussels, Bel-gium. Email: [email protected]

http://www.ich.org/LOB/media/MEDIA483.pdf

http://www.emea.europa.eu/pdf/human/opiniongen/49892006eu.pdf

http://www.ich.org/LOB/media/MEDIA4930.pdf



SNAPSHOTS

real outcome versus surrogate outcomedata, morbidity and mortality rates wouldhave been adversely affected. In otherwords, millions of lives were saved as aresult of reimbursement decisions basedon a reasonable review of available data,with the understanding that as further databecame available that amendments couldbe made to how products would be reim-bursed. This exemplifies a ‘patients-first’approach.

Public payers themselves have charac-terised the debate in this manner and arealready posing the reasonable question –what is ‘adequate’ in terms of data andinformation requirements to ensure duediligence in the review of medications yetis also ‘feasible’ to request of manufac-turers at the front end of the approvalprocess? Posed in this way, one needs to bemindful of the patient impact of delays orrestrictions on novel medicines.

In the past twenty years alone, innovativemedications have helped to reduce hospi-talisation rates dramatically for ulcers,HIV/AIDS, diabetes, respiratory diseasesand liver diseases among others. In thatsame time frame, death rates have also beenreduced dramatically for cardiovascularand HIV/AIDS patients to cite twoexamples.4

Instead of establishing new regulatory andreimbursement hurdles, we should be pro-viding incentives for innovation thatexpedite access for patients and will allowcertain innovative drugs to be fast-trackedby, for example, bypassing customarycost-effectiveness review.5

Leading clinical practice is guided byhealth professionals that are swayed mostby persuasive scientific evidence and whatis in the best interests of their patients.Marketing has a role and can be effectivebut if it is not based on strong scientificevidence and on advancing patient health,it will not resonate convincingly withleading clinical practitioners.

We have previously pointed out thecomplex and high risk nature of discov-ering new medicines. The research anddevelopment costs for one drug have beenestimated to be over $800 million.6 Clearlyfunding by both public institutions andprivate firms has a critical role to play inadvancing pharmaceutical research anddevelopment and finding the next cure,treatment, or vaccine. In an era of difficulteconomic circumstances, providing greaterincentive for innovation by the privatesector is a particularly productive way to

improve patient health. It is puzzling thatone would advocate the reduction ofexceptional scientific minds that areapplying themselves fully to the discoveryof treatments and that are being financedby means other than by taxpayers. Thevalue of pharmaceutical innovation restsultimately in providing better health care,better quality of life, and the ability to livelonger for patients.4 Pharmaceutical com-panies and publicly funded bodies have arole in fully capturing this value.

REFERENCES

1. Porter, Michael. Value-based HealthCare Delivery. Presentation, University ofToronto, 11 June 2009.

2. Porter M. Redefining Health Care: Creating Value-based Competition on

Results. Cambridge, MA: Harvard Business School Press, 2006.

3. Best Brain Consultation: The Data Divide – Determining the Adequacy andFeasibility of Data for Funding Decisions.Forum held by the Canadian Institute ofHealth Services and Policy Research andthe Ontario Ministry of Health and Long-Term Care. The University of Toronto,June 2009.

4. Griller D. Pharmaceutical Research andits Value to Canadians. Montreal: SECOR,2007

5. Reuters Health. UK Plans to Let SomeDrugs Bypass Value Watchdog. 14 July2009.

6. DiMasi JA, Hansen RW, GrabowskiHG. The price of innovation: new esti-mates of drug development costs. Journalof Health Economics 2003;22(2):151–85.

EU integration and health systems

San Servolo, Venice, 25–31 July 2010

The European Observatory on Health Systems and Policies ishappy to announce the Observatory Venice Summer School2010. Jointly organised with the Veneto Region – one of theObservatory’s partners – the Summer School will look at thegrowing influence of European integration and regulation onhealth systems, and the practical opportunities and chal-lenges that this creates for patients, professionals and pol-icy-makers. It will explore different EU policy fields to identifylinks with health and assess their impact on health systems.

The main aim is to identify key issues where the EU creates challenges for national and regional health systems; share participants’ insights (whether they arehealth professionals, policy makers or analysts); andbuild contacts and networks to help respond.

The course will be organised into three modules:

� The institutional and regulatory framework

� Economic integration and health systems’ governance

� Supportive EU policies and instruments for health systems governance

In addition to the lectures, an important part of the programme is dedicated to exchange between participantsand group work. A policy round table will be organised, involving various policy-makers and representatives of institutions, such as the WHO Regional Office for Europe and the European Commission.

Observatory Venice Summer School 2010

For more information and an application, see www.observatorysummerschool.org

The Summer School is intended for senior tomid-level policy-makersand more junior professionals who aremaking careers in policyand management at a regional, national or European level.

on Health Systems and Policies

European

http://www.observatorysummerschool.org


SNAPSHOTS

Many millions of adults in Europe arereceiving social care, which can be definedas support for individuals with the activ-ities of their daily lives, which can rangeacross personal needs, domestic tasks,social activities and friendship. Most of thissupport is unpaid care from family andfriends, but there are also large numbers ofcommunity organisations, charities, for-profit (private) companies and state bodiesdelivering ‘organised’ care services.

With the ageing of populations inEuropean countries, and indeed with thelonger survival into old age of increasingnumbers of people with disabilities andenduring illnesses (people who, in previousgenerations, would generally not havelived for as long), the future social carechallenge facing Europe is clearlyenormous.

The largest groups of users are olderpeople, children and adolescents, peoplewith long-term disabilities or conditions,and those with sensory impairments.Depending on the country, other groupsmight be using social care services. Indeed,the term ‘social care’ is not universallyapplied: other common terms are ‘welfareservices’, ‘personal social services’, and‘social services’. Unlike health care, thereis less international consensus not onlyabout terminology, but about what isincluded in the sector, and certainly there isless awareness among the general popu-lation of the social care needs of

individuals or what services can do to meetthem.

Again, in contrast to health and healthcare, the evidence base upon whichpractice and policy decisions are taken insocial care is rather less well developed.Although hard to substantiate with figures,it would generally be recognised that therehas not been the same level of investmentin robust research. Consequently, govern-ments, state agencies, communityorganisations and others do not have muchof a platform of evidence about how tomeet needs, improve quality of life, orpursue cost-effectiveness.

ChallengesIt is an enormous task to ensure thatsupport and care are available for peoplewho need them, and that the arrangementsare what those individuals want. So too isthe task of generating and organisingresources so as to achieve the best out-comes in an efficient, equitable manner.Another challenge is to dovetail responsesand activities across different sectors –making sure that central, regional and localgovernment agencies work effectively withthe voluntary and community sector, aswell as with for-profit entities.

Most importantly, responses must beplanned sensitively and appropriately withfamilies and other unpaid carers. There isalso an obvious need to make sure thataction across different service systems –particularly social care, health, housing,education, social security and transport –

is coordinated with the best interests andthe preferences of the individual in mind,while cognisant of resource constraints.

Research needsClearly social care touches the lives ofmany people. It contributes a huge amountto the nation’s well being and health. Tosupport the development of social carepractice in Europe, there is a need forresearch evidence on what people want,how it can be provided, what works andwhat it costs. All of this is needed toprovide policy makers with the tools todevelop innovative, cost-effective services.

Evidence generated by research has thepotential to contribute substantially tomeeting these challenges. But that researchneeds to be carefully planned, competentlyexecuted and skilfully communicated totarget audiences.

New investment in adult social care research in EnglandThe National Institute of Health Research(NIHR)*, located within the Departmentof Health, spends considerable amounts onhealth and social care research in England.Established in April 2006 to carry forwardthe vision, mission and goals outlined inthe Government’s health research strategyfor England, Best Research for BestHealth, the NIHR had a £790 millionrevenue budget with £31 million capitalfunding in 2008/09.1,2 Its vision is toimprove the health and wealth of thenation through research.

Social Care: a new initiative inEngland to fill evidence gaps

Martin Knapp and Angela Mehta

Martin Knapp is Professor of Social Policy,Director of the Personal Social ServicesResearch Unit and Director of the NIHRSchool for Social Care Research, LondonSchool of Economics and Political Science.Angela Mehta is Finances and Communi-cations Administrator, NIHR School ofSocial Care Research, London School ofEconomics and Political Science. Email: [email protected]

* The National Institute for Health Research (www.nihr.ac.uk) provides the frameworkthrough which the research staff and research infrastructure of the National Health Service(NHS) in England is positioned, maintained and managed as a national research facility. TheNIHR provides the NHS with the support and infrastructure it needs to conduct first-classresearch funded by the Government and its partners alongside high-quality patient care, ed-ucation and training. Its aim is to support outstanding individuals (both leaders and collab-orators), working in world class facilities (both NHS and university), conducting leadingedge research focused on the needs of patients.


http://www.nihr.ac.uk

The impacts of social care services both tothe public purse and to individuals inEngland are substantial (Box 1). In 2008,the Department of Health in Englandannounced plans to set up a nationalSchool for Social Care Research (SSCR),to be established within the NIHR. Thenew School formally began work in May2009 with a budget of £15 million over fiveyears, almost all of which was to be spenton new research.

The School is a partnership between sixleading centres of social care research inEngland. It is directed by Martin Knapp(London School of Economics andPolitical Science) and there are five Asso-ciate Directors: David Challis (Universityof Manchester), Caroline Glendinning(University of York), Jill Manthorpe(King’s College London), Jim Mansell(University of Kent) and Ann Netten(University of Kent). Its primary aim is todevelop the evidence base for adult socialcare practice in England and so help toimprove the quality of care and supportexperienced by individuals and families. Itwill conduct and commission high-quality(‘world class’) research to produce newknowledge (including, where appropriate,reviews and syntheses of existing evidence)to inform the development of adult socialcare practice in England.

Consultation and commissioningThe School is consulting with a wide rangeof people interested in social care –whether as users, unpaid carers, paid prac-titioners, providers, managers, strategicdecision-makers, and researchers. Morethan a hundred research suggestions havebeen received thus far. One reason is toidentify areas where new research evidencecould help to improve practice and soimprove people’s lives. The School is alsoworking with an Advisory Board of highlyexperienced, motivated individuals; andwith a User, Carer, Practitioner ReferenceGroup to develop research ideas and toensure wider involvement in the projectsthat are funded.

The SSCR is now commissioning researchprojects with a clear element of originality,and which have relevance and potential toimprove adult social care practice inEngland. Research can be commissionedfrom anywhere – not just from researchersin England – but the findings must be rel-evant to English adult social care. Furthercalls for proposals are expected in 2010 anddetails will be provided on the School’swebsite (www.sscr.nihr.ac.uk), which also

has summaries of commissioned studies.

The School is also currently commis-sioning expert reviews on researchmethods in the field, with a numberrecently agreed (for completion bysummer 2010). They focus on:

– Randomised controlled trials

– User-led research

– Modelling

– Research methods and visualimpairment

– Observational methods with a focuson learning disabilities

– Sexualities in social care research

– Outcome measurement overview

– Cost-effectiveness

– Large-scale datasets

– End-of-life care research methods

– Social care research and black andminority ethnic groups

– Research in care homes

– Qualitative methods

– Systematic reviewing

It takes longer to commission researchprojects, but again some progress has beenmade. Among those projects commis-sioned are: a scoping study focusing onindividualisation of services; an investi-gation of practice models for social carepractice with carers; a scoping study oncare and support for people with complexand severe needs, looking at innovationsand practice; and a study of the costs andoutcomes of skilled support for adults withcomplex needs in supported accommo-dation. Another five projects are soon tobe commissioned.

Path-breaking initiativeThe NIHR School for Social CareResearch is the first of its kind. It was theinitiative of Professor Dame Sally Davies,Director General of Research and Devel-opment at the Department of Health, whoannounced the establishment of the Schoolwith the aspiration that “the new NIHRSSCR … will give researchers the time and

funding to ask the important questions andimprove our understanding of whatworks, what doesn’t work and why. Thisnew School will provide considerablebenefit to the health and well-being of thepopulation through the new knowledgegained.”

Social care aims to reduce, lessen the con-sequences of, or compensate for disabilityor disadvantage by supporting families andcommunities as well as empowering indi-viduals by lessening their dependence, andto improve quality of life. A key objectiveis often to support people so that they canenjoy the ordinary, everyday aspects of lifeexperienced by the rest of the population.In this context of a multitude of unan-swered questions about social care, £15million is modest, but it represents a veryimportant step in the development of thisresearch area.


SNAPSHOTS

Social care practice in England

In England, social care services are utilisedby many people and much of the populationwill use such services in their lifetime – thelifetime risk of entering residential or nursinghome care is around one in six for a manand one in three for a woman in England. In2007–08, 1.75 million adults in Englandused social care services, with a spend of£16.5 billion by local municipalities on socialcare for adults, while another £3.5 billionwas spent by older people on their own carebecause they were ineligible for public financial support.

Social care provision in England is providedthrough services and support offered by localauthority adult services departments, the in-dependent sector, third sector organisations,unpaid family and other carers. In 2007–08there were approximately 18,000 carehomes with 450,000 places for adults and42,000 home care agencies in England, withan additional one million people supported intheir own homes.3 About 1.5 million peopleworked in adult social care, and 5.2 millionpeople provided unpaid care (and a third ofthem did so for twenty or more hours perweek).

For further information visit the School’s website at www.sscr.nihr.ac.uk or contact theSSCR ([email protected]).

ACKNOWLEDGEMENTSThis paper was prepared as part of the work of the Department of Health’s NIHR Schoolfor Social Care Research. The views expressed in this publication are those of the authorand not necessarily those of the NIHR School for Social Care Research or the Departmentof Health, NIHR or NHS.

http://www.sscr.nihr.ac.uk

http://www.sscr.nihr.ac.uk



SNAPSHOTS

This snapshot looks at the Child and Ado-lescent Mental Health in an EnlargedEuropean Union: Development ofEffective Policies and Practices(CAMHEE) project. This European Com-mission (EC) funded project aimed toprovide a set of guidelines for effectivemental health policies and practices. Oneelement of the work was to map researchon best practice with the specific objectiveof analysing community based child andadolescent mental health (CAMH) activ-ities, specifically focusing on successfulexamples of deinstitutionalisation. Theresearch uncovered predominant serviceareas, the most frequently targeted clientgroups, philosophies and ways in whichservices are structured, budgets, financingand other aspects of service provision. Themost problematic issues identified by theresearch were political passiveness and alack of transparency in some settings.

Moving up the European policy agenda It is stated that European citizens have aright to a good mental health. This espe-cially should be true for our youngestgeneration, upon whom rest our futurehopes for strong social cohesion, produc-tivity and better health. Through theenlargement of the European Union (EU)in 2004, as well as in preparations for aWorld Health Organization (WHO)European Region Ministerial conferenceon Mental Health in 2005, the importanceof CAMH began to be addressed throughthe concerted efforts of the EC, WHO andnational authorities of EU member states.Recommendations of a pre-conference onChild and Adolescent Mental Health inLuxembourg in September 2004, as well asthe final Declaration and Action Planapproved in the Ministerial Conference onMental Health in Helsinki in January 2005,put a clear emphasis on the urgent need forthe development of effective CAMHpolicies and practices in an enlargedEurope. Most countries that joined EU in2004 and 2007 have had to contend withmajor problems in the field of CAMH,revealed by strikingly high rates of poormental health among children and youngpeople.

There remains a concern that in manycountries in central and eastern Europefinancial and human resources are still

largely invested in services that contributeto traditional patterns of social exclusion,institutionalisation and stigmatisation ofchildren, youth and parents at risk. Thiscreates and reinforces the vicious circles ofa culture of dependence, learned help-lessness, exclusion and a lack of tolerance.Many new EU member statesacknowledge that they need to undergo acomplicated transition to a system basedon principles of participation, theinvolvement of families and communitiesand strong primary care involvement.Moreover, there needs to be an emphasisplaced on mental health promotion and theconcept of citizenship as basic prerequi-sites for the good mental health of childrenand their parents.

The CAMHEE initiative: mapping bestpracticeIn January 2007 a new EU-wide initiativein CAMH emerged in Lithuania, throughthe creation of the CAMHEE project sup-ported by the EC’s Public Healthprogramme. As noted above, CAMHEEhad the objective of providing a set of rec-ommendations and guidelines for effectiveCAMH policy and practice in EU, with aspecial emphasis on new EU memberstates. It was conducted in light of theDeclaration and Action Plan endorsed byWHO European Ministerial Conferenceon Mental Health in 2005.

REFERENCES

1. Department of Health. Best Research for Best Health: A New National Health Research Strategy. London: Department of Health, 2006. Available at:http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/Researchanddevelopmentstrategy/DH_4127109

2. Commission for Social Care Inspection.State of Social Care in England 2007–08.London: CSCI, 2009. Available at:http://www.cqc.org.uk/_db/_documents/SOSC08%20Report%2008_Web.pdf

3. Department of Health, Research & De-velopment Directorate. Delivering HealthResearch: National Institute for Health

Research Progress Report 2008/09, London:Department of Health, 2009. Available at:http://www.nihr.ac.uk/files/Publications/296542_DeliveringHealthResearchReport_acc3.pdf

Child and adolescent mentalhealth in Europe

Research on best practice

Dainius Puras and Egle Sumskiene

Dainius Puras is Associate Professor, Institute of Institutional Relations andPolitical Sciences and Egle Sumskiene isbased in the Social Work Department,Vilnius University, Lithuania. Email: [email protected]

Further information on the CAMHEEproject is available athttp://www.camhee.eu/

http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/Researchanddevelopmentstrategy/DH_4127109

http://www.cqc.org.uk/_db/_documents/SOSC08%20Report%2008_Web.pdf

http://www.nihr.ac.uk/files/Publications/296542_DeliveringHealthResearchReport_acc3.pdf


http://www.camhee.eu/

The general approach was based on theunderstanding that new EU member stateshave to make proactive concerted effortsto develop effective approaches to CAMHpromotion. They need to evaluate the newsituation, and identify opportunities foraction, as well as gaps to be plugged, bydrawing on the rich experience of EU 15countries. One element of the work was tomap research on best practice, with theobjective of analysing community basedCAMH activities, specifically focusing onsuccessful examples of deinstitutionali-sation of children with disabilities andother risk factors.

A bespoke questionnaire was developedand disseminated to health, social care andeducational organisations that had someresponsibility for CAMH. This researchwas conducted between May and July,2008. Sixty-four questionnaires were com-pleted by experts in Lithuania, Bulgaria,Norway, Germany, Belgium, Latvia andGreece. Forty-seven organisations werefrom new member states. Data wereanalysed using the Statistical Package forSocial Sciences (SPSS) and MicrosoftExcel. Descriptive statistics were appliedto the data analysis.

Survey resultsApproximately two-thirds of participantorganisations indicated that their mainservice domain comprised of primary andsecondary prevention (66%), psychosocialcare (64%) and the provision of educa-tional services (61%). Families were mostfrequently targeted, with 92% of organi-sations providing services to families.Emotional and conduct disorders were themost frequently targeted problems (70%and 69% respectively) reported by respon-dents. Providing services to victims ofabuse and individuals with poor parentingskills was also noted as an importantactivity (62%).

79% of respondents emphasised thatteamwork was the overarching serviceprovision philosophy. Community-basedservice provision was the second mostessential issue, with two-thirds of organi-sations surveyed mentioning itssignificance. More than half indicatedusing client involvement (58%), a riskmanagement approach (53%) or individualengagement-based care (53%). The mostpopular way (81%) of service structuringwas to offer training to non-medicalclientele to implement interventions, aswell as increasing the competence of pro-fessional staff, including psychologists. A

considerable number of organisations(71%) had an agreed procedure forarriving at case-formulation through con-tributions from their staff members andother sources. Only one third of organisa-tions used data such as the average numberof sessions, duration of care episodes orcosts to indicate their involvement withspecific cases.

The majority of organisations (65%) sur-veyed offered their services for free; almostone-third (31%) stated that they had amixed system of charging; less than 5%fully charged for services. When pricingtheir services, only 16% applied marketprices, while one third used their ownprice lists. The remainder employed avariety of strategies for setting prices.

Projects, rather than maintenance grants,are the main source of financing (58%),which raises questions about the sustain-ability of some services. The respondentsidentified two key sources of funding:local government (26%) and central gov-ernment (20%). 22% supplemented publicfunds with their own income, largely gen-erated through fees paid by service users,as well as membership subscriptions,donations and the time of volunteers.

The majority of the organisations areautonomous (60%), while one-third areintegrated into other services (33%). Whenintegrated, organisations usually notedthat they held a special position, havingbeen founded by an institution (forexample, a municipality or hospital) butenjoying extensive autonomy. One of theorganisations described its functioning asseparate and autonomous but dependenton specialist care units for service pro-vision.

Despite the fact that research participantswere identified as ‘best practice’ examples(and respondents also stressed theirachievements instead of problems), thequestionnaires revealed several challenges.First of all, participants remain inactive inthe sphere of policy development; less thanone-third (31%) stated they had taken aproactive stance. This fact may signal a dis-crepancy between services provided andpriorities in national mental health policy.Gaps in legislation, coupled with unclearmandates for different actors in the field,have created uncertainty, with overlappingservices on the one hand and serious gapsin service provision on the other.

Though human rights violations for indi-viduals in residential mental healthinstitutions represent significant challenges

for new EU member states, approximatelyone fifth also indicated deinstitutionali-sation as an essential element of theirfuture activities. A similar trend was iden-tified when analysing targeted problems:institutional stigma turned out to be theleast interesting issue for respondents, withonly 23% being active in this area.

Secondly, we encountered a significant lackof evaluation culture, evidence basedservice evaluation and monitoring. 85% oforganisations chose to carry out an internalevaluation of services provided, whereasonly 51% were subject to any externalevaluation. External evaluation is likely tobe more objective, critical and show thereal state of the affairs. Organisations in‘old’ member States more oftenacknowledge the importance of such eval-uation, unlike the situation in eastern andcentral Europe where they remain com-mitted to internal evaluation. Thissituation reflects different democratic tra-ditions, attitudes towards clients, qualityof services and a lack of constant verifi-cation of compliance with national mentalhealth policy.

Interestingly, several organisations fromnew member states claim to use informalconversations instead of any official com-plaints mechanism, implying thatunregistered complaints do not appear inthe records. This may hide dissatisfactionwith services provided. Sharing experienceof best practices and moving towards abetter culture of evaluation and evidencebased decision making process would helpto identify strengths, weaknesses and chal-lenges for the development of evidencebased and sector wide national CAMHpolicies in both the current enlarged EUand candidate countries.

It is hoped that the outputs of theCAMHEE project, allowing for theexchange of positive experiences and facil-itating cooperation across countries, willprovide a new impetus and support forbetter mental health promotion, mentaldisorder prevention and treatment forchildren and adolescents. However, neg-ative factors, like the apparent lack ofexternal evaluation and political pas-siveness of some research participants innew EU member states, allow us topresume that this is only the tip of theiceberg and that there is much more to do.Child and adolescent mental healthrequires much more academic, politicaland social awareness, as well as supportand incentives for further development.


PUBLIC HEALTH PERSPECTIVES



The startD’Souza,1 stated that the origins of thePeriodic Health Examination (PHE) orscreening occurred in a brothel in the papalstate of Avignon in 1347, “when an abbessand a local surgeon, every Saturday, singlyexamined women ‘in the home’ and if anyof them had contracted any illness by theirwhoring, they were separated from the restand not allowed to prostitute themselvesfor fear the youth who had to do withthem should catch their distempers.” Thisaccount is an early record of screeningapplied in the cause of community med-icine and antedates by at least fivecenturies, the use of medical examinationfor the apparently healthy to prevent thespread of disease.

The precise origin of PHE is difficult totrace but it has been suggested that theintellectual beginnings were due to aBritish physician, Horace Dobell,2 arenowned clinician, author and expert ontuberculosis and diseases of the chest.Dobell proposed the periodic health exam-ination as a way to identify “these earliestinvasive periods of defect in the physio-logical state and to adopt measures fortheir remedy”.

In the United States (US), the public healthuse of screening probably first becameestablished in the mid 19th century when,in conjunction with quarantine regula-tions, it was applied to immigrants. Itsvalue in checking the flow of epidemicswas taken for granted and at no time wasits effectiveness tested. At the beginning ofthe 20th century, medical examinationswere recognised as being of use toinsurance companies for the purpose ofrejecting or loading the policies of poorrisk clients. The terms PHE and screeninghave similar meanings and are used inter-changeably.

PHE in the USIn the US, the first universal PHE pro-posals began to appear at the turn of the20th century. Possibly the first to suggestthis was George Gould, a national figurein the medical community.3 In 1915, theNational Tuberculosis Association desig-nated a week for general physicalexaminations. This helped popularise theseexaminations as a tool for the early diag-nosis of disease in general, and tuberculosisin particular.4

Organised medicine also played a majorrole in the development of the PHE. In1922 the American Medical Association(AMA) officially endorsed PHE and begana campaign to spread its practice in 1923.5

A manual for physicians was published.6

George Rosen4 argued that organised

medicine saw the examination as servingthe instrumental purpose of enhancing theposition of the practitioner in the com-munity, particularly in the wake of itsopposition to compulsory healthinsurance. However, it has to be noted,that in the early 20th century, there was agreat deal of neglect of periodic healthexaminations and apathy from the public.

The benefits of screening were firstdemonstrated by the use of mass miniatureradiography (MMR) for the identificationof individuals with tuberculosis. The useof MMR became common in many coun-tries with the introduction of effectivetreatment for tuberculosis after 1946. Withthe reduction in the burden of tubercu-losis, the application of screening for otherchronic conditions began to be considered.This was particularly marked in the US,where a law on the control of chronicdisease and the availability of screeningwas passed in the late 1950s. A Com-mission on Chronic Illness7 was foundedin 1957, and a major review published inthe Journal of Chronic Disease.8

There was also the development of whatbecame known as “multi-phasicscreening”; the performance of multipletests aimed at detecting unrecogniseddisease or defects. The objective was thatscreening should involve physicians onlyminimally, and be done by using tech-nology that could be applied economicallyand efficiently. First conducted in

Periodic Health Examination – A brief history and critical assessment

Walter Holland

Summary: The development of the periodic health examination (PHE) is outlinedwith a critical analysis of the evidence for its benefits to health improvement. Thepolicies of governments in supporting the use of PHE are questioned. Evidence is presented that population policies are more effective in health improvement and reducing social-health inequalities. PHE is more an attractive populist measure andsupported by commercial interests. The lack of effectiveness in improving health, increasing health inequalities and its unfortunate side-effects are ignored.

Keywords: periodic health examination, multiphasic screening, screening, history,public health policy

Walter Holland is Emeritus Professor ofPublic Health Medicine and Visiting Pro-fessor, LSE Health, London School ofEconomics and Political Science, UK.Email: [email protected]


California and Massachusetts, this spreadthroughout the US. Prepaid group practicehealth care was a final important influenceon the periodic health examinationthroughout the mid 20th century.

The most influential experience was that ofthe Kaiser Permanente Health Plan in theSan Francisco area, due to the financialincentive structure of prepayment. Anobjective was the satisfaction of over-whelming patient demand for healthcheck-ups. This led Kaiser to seek ways tomaximise the efficiency of the examina-tions.9 An automated multi-phasicscreening procedure that incorporatedcomputerised test equipment and dataanalysis was developed. Opinion pollsindicated a growing popular belief in thevalue of these examinations. However, itbegan to be accepted that the effectivenessshould be examined.

PHE in the UKThe situation in the UK was somewhatdifferent. In 1926, an experiment wasestablished in London at the PeckhamPioneer Health Centre.10 This providednot only general practice and medical care,but also family planning advice and routinefamily health screening. This screeningconsisted both of formal medical examina-tions with laboratory tests and informalsurveillance. While the purpose of thisscreening was not simply to act as a diseasesieve, it was a natural, though incidental,part of the general aim of promoting healthand attending the health centre. Nothingshort of a periodic health overhaul on anational scale, the health centre thoughtcould lead to the rational application ofmedical science and the elimination ofsickness! When the National HealthService was established in 1948, the lessonslearned from the Peckham experimentwere ignored. Unlike the US there was nocomparable demand for PHE.

PHE in other countries and WHO guidanceExperiments and practice in PHE werealso undertaken in Australia, Canada,France, Germany, Ireland, Israel, Italy,Japan, New Zealand, Norway, Scotlandand South Africa. Despite the enthusiasm,or perhaps because of it, in the late 1960s,the value of screening (periodic healthexaminations) began to be tested andexamined more critically. WHO commis-sioned a comprehensive review ofscreening worldwide which enunciated tencommon sense criteria to be applied before

consideration of screening for a particulardisease.11 These were:

1. The condition sought should be animportant health problem.

2. There should be an accepted treatmentfor patients with recognised disease.

3. Facilities for diagnosis and treatmentshould be available.

4. There should be a recognisable latentand early symptomatic stage.

5. There should be a suitable test or exam-ination.

6. The test should be acceptable to thepopulation.

7. The natural history of the conditionincluding development from latent todeclared disease, should be adequatelyunderstood.

8. There should be an agreed policy onwhom to treat as patients.

9. The cost of case-finding (including diag-nosis and treatment of patientsdiagnosed) should be economicallybalanced in relation to possible expen-diture on medical care as a whole.

10. Case-finding should be a continuingprocess and not a ‘once and for all’project.

Definitions and objectivesIn 1968, the Nuffield Provincial HospitalsTrust produced a book12 which dealt withthe current state of the art of screening fora number of conditions. The general toneof this book was less enthusiastic than theliterature of the preceding century. A seriesof articles in the Lancet13 was also morecritical of screening and it emerged thatmost of the good evidence in favour ofscreening centred around pregnancy andearly childhood. Following this series ofarticles, letters to the Lancet revealed ele-ments both of confusion and dissent in thedebate on whether public health servicesshould increase their involvement withscreening. Sackett and Holland,14 in char-acterising the opposing teams as ‘snails’and ‘evangelists’, produced a cogent expla-nation of the main elements in the debate.They observed that the key to much of theargument lay in confusion over the use ofterms, particularly what was meant byscreening or PHE. There is still no univer-sally accepted definition, and most doctorssimply look upon screening (or PHE) asthe use of any sort of test to identify pos-sible disease.

Sackett15 discussed motives for screening,suggesting that there were four reasons.Firstly, to influence the gamble of lifeinsurance; secondly, to protect peopleother than the patient, as in industrial andpublic health screening; thirdly, to obtainclinical baselines and fourthly, to do thepatient some good, so called, prescriptivescreening. Obviously there are also othermotives, such as financial reward and bio-logical research, satisfying public andmedical demand and gaining informationfor administrative purposes. Many timesthese are all combined in one.

Effectiveness of screening and PHEOne of the earliest attempts to demon-strate the effects of screening originatedwith the use of screening by insurers.Knight16 produced evidence that suchscreening might be effective in saving lives.He reported that over a five year period,only 217 deaths occurred, where 303would have been expected in an uninsuredpopulation of 6,000. A similar study17 on apopulation of 20,648 men having employersponsored PHEs reported a favourableratio of actual to expected deaths, but wasmore cautious in interpretation and rec-ommended that prospective studies shouldexamine the question.

There are at least three ways in which falseconclusions can be reached in this field.Firstly, regression towards the mean, anatural tendency for high or low readingson one occasion subsequently to be nearertheir mean level, may easily, and erro-neously, be interpreted as clinicalimprovement in longitudinal screeningfollow-up studies. Secondly, the increasedsurvival, of say, a cancer patient afterdetection by screening might be inter-preted as a benefit of early diagnosis but infact, be a reflection of the so-called ‘lead’time, that is that the total duration of thedisease process has itself remainedunchanged, but since the diagnosis wasmade earlier, the patient appears to survivelonger. Finally, there is the danger that thenet of any screening process will tend toselect out the more chronic and least severediseases which by definition, will have amore favourable, clinical cause - again,tending to suggest that screening was ben-eficial.

Rodney Beard in 1959, an influential voicein the US, suggested that periodic medicalexaminations should be examined morecritically. He pointed out that there weretwo factors in PHE: disease detection andhealth counselling. The randomised con-



trolled trial undertaken at the Kaiser Per-manente was one of the first to examine theproblems of periodic medical examina-tions.18 About 10,000 people were chosenat random from the 46,000 who were Planmembers in1964, and they were then ran-domly divided into equal control andtreatment groups. The first seven years ofthe study were evaluated and comparisonsmade. Overall death rates were not signif-icantly improved in the screening group.19

However, two specific causes of mortality,in particular age groups, did appear to besignificantly improved in the screeninggroup. But as sixty significance tests wereperformed on these mortality data, this isapproximately the same outcome that onewould expect purely by chance. Theauthors failed to make this point clearly inthe discussion of their results. Morbiditymeasures, such as physician consultationrates and hospital admission rates did notsignificantly differ between the groups.There was little change in these findings atsixteen years.

A further controlled study was undertakenby Olsen, Kane and Procter, on smallernumbers and over only three years.20 Thisfailed to show any measurable morbiditybenefit in favour of screening.

A well designed controlled trial ofscreening was carried out in Malmö,Sweden, in 1970.21 Men born in 1914 andresiding in the town were randomly allo-cated to screening and control groups.Following screening, intervention concen-trated upon treating blood pressure greaterthan 165/110 and smoking. After fouryears the death rate in the two groups wasnot statistically significantly different,however, there was a significant shift in thecauses of death. Twice as many men diedof cardiovascular disease in the controlgroup. This was offset by nearly twice asmany deaths from cancer and other causesin the screening group. As the authors didnot provide any evidence that they hadlowered blood pressure and smoking levelsin their screening population over the fouryear period, it might well be that theobserved difference in their screening pop-ulation over the four year period was dueto random fluctuation rather than thescreening programme.

A further randomised controlled trial wasundertaken in England by the Departmentof Clinical Epidemiology and Social Med-icine at St. Thomas’ Hospital and groupgeneral practices in St Paul’s Cray inKent.22 Within two large group practices,all persons aged 40-64 in 1967 were iden-

tified and then randomly allocated, byfamily and within a general practitionerlist, into two equal groups, designated‘control’ and ‘screening’. The screeninggroup, numbering 3,297, was invited bypersonal letter from their general practi-tioner to be screened.

The overall response rate of thoseattending for screening was 73.4%. Subse-quent to screening, all information waspassed to the general practitioner who thendid a physical examination on each subjectand decided on further tests, diagnosis andtreatment. The same group of patientswere invited to re-attend the screeningclinic in 1969, the response this time wassomewhat lower being 65.6%. Both thecontrol and screening groups wereexamined after seven years and their levelsof function were assessed. Overall, themortality in the screening and control pop-ulation was not significantly different. Nosignificant difference appeared between thestudy and control groups for any of thevarious causes of death. There were no sig-nificant differences in certified sicknessabsence, use of home help or hospitali-sation between the control and screeningpopulations. There appeared to be a higheroverall consultation rate observed in thescreening population compared to thecontrol, but that could perhaps be becauseof the need to investigate the findings atthe initial screen. The economics ofscreening showed that, if introduced in thetotal population, it could increase costs tothe National Health Service by about 10%,largely because of the examinations whichhad to be done following screening. Thus,the value of periodic health examinations(or screening), in this population in theUK was doubtful.

In Japan, comprehensive periodic healthexaminations have been undertaken formany years. There is little evidence of any,other than belief, that it is of any value.Analysis of the procedure showed that itincreased health care utilisation and costs.The only possible benefit was that therewas an increase in health care utilisation.23

A more recent systematic review of thevalue of periodic health evaluation in2007,24 was unable to show anyimprovement in outcomes in any of thestudies examined. The authors concludedthat PHE improves delivery of some rec-ommended preventive services and maylessen patient worry, although additionalresearch is needed to clarify the long termbenefits, harms and costs of receiving thePHE. This was not a very comprehensive

review as two controlled trials wereomitted20, 21 and the assessment of themethods and results of others, was notvery critical (for example, 18, 22).

Changes in attitude in recent yearsOpinion has changed in the UnitedKingdom over the past twenty years.Whereas in the 1960s, PHE’s were pro-moted by the medical profession anddisregarded by the population , now themedical profession considers them to be ofdubious value and view them with scep-ticism .

A recent article in the consumer magazineWhich,25 cautions the population on theuse of these check-ups which cost, onaverage, £423, particularly the use of scanson people without symptoms. It empha-sises the need to link the check-up withappropriate interventions through theNHS. A commentary in the BMJ by ageneral practitioner26 also notes a sound ofcaution – “in the public psyche there is anunshakeable belief that screening is a goodthing. But many doctors, myself included,are sceptical of the absolute benefit ofscreening; the simplicity of the claim that‘early diagnosis’ saves lives is too seductiveand open to confounding to be whollytrue” and continues “tear stained reasoningshould not blind us to the fact thatscreening for skin, breast, cervical andprostate cancer (not to mention screeningfor high cholesterol, hypertension orosteoporosis) generates overdiagnosis,overtreatment and health anxiety. Doctorsare complicit in the theft of society’s mostprecious possession of all; a sense of well-being. So let’s repeat: screening, whateverits benefits, also causes widespread, real,and lasting harm.”

The aims of health policy – improvementsin health – recent developmentHealth measures are intended to improvehealth. The aim of screening and PHE isintended to identify symptoms and signsin individuals at a stage when the conditionis treatable and reversible. An alternativefor health improvement and reduction inthe burden of common diseases whichhave their roots in life-style, social factorsand the environment depends upon a pop-ulation-based strategy of prevention ratherthan an approach to identifying andtreating ‘high-risk’ individuals. Thesealternatives have been analysed by Rose27

who concludes that a population-basedapproach is better and more cost-effectivefor common diseases. For relatively



uncommon conditions screening may bebetter if an effective form of treatment isavailable. There have been many publica-tions reviewing individual screening tests(for example Holland and Stewart 28).Some health administrations have estab-lished national bodies responsible forreviewing individual tests and procedures(for example, UK National ScreeningCommittee, US Preventative Services TaskForce).

In spite of all these reservations identifiedby research, the UK government isplanning to implement ‘Health Checks’ inEngland for all individuals aged forty andover. These proposals have not beenincluded in the procedures approved bythe UK National Screening Committeesince they do not meet its stringent criteria.The term ‘health check’ is also a misnomer,what is intended is a structured riskassessment in general practice for coronaryheart disease, cerebrovascular disease andtype II diabetes. Economic assessment hasbeen done on the basis of a number ofcomplex models. The modelling showsthat the impact of the programme wouldbe significantly beneficial. The total costper ‘Quality Adjusted Life Year’ is esti-mated at about £3,500, which is consideredto be a very good use of NHS funds by thegovernment.

Periodic health checks and screening arenow very popular procedures. A priorithey should be effective in reducing theburden of disease and improving well-being. Unfortunately the reality seems tobe less attractive. Most of the proponentsneglect the unfortunate side-effects ofincreasing anxiety, overtreatment andoverdiagnosis which have been well-documented.26,28 The results of ran-domised controlled trials which assessedoutcomes such as mortality, morbidity anddisability have not confirmed the hopes ofthe well-intentioned proponents, in spiteof changes in some of the risk behavioursand increase of health service utilisation,particularly in countries with a competentprimary care system. It is unfortunate thathealth authorities, worldwide, have neg-lected the need to conduct rigorous,long-term, pragmatic controlled trials withappropriate outcome measures and rely onsuperficially attractive policies based onmodelling and ‘expert opinions’ or processmeasures. This short-termism is an unfor-tunate manifestation of all current policies– whether it be economic or health. Thedivide between snails and evangelists per-sists. It is unfortunate that the lesson

propounded by Rose27 is neglected in theUK. Cardiovascular disease (CVD) (andrisk factors) is extremely common in theUK population and part of health policy isto reduce inequalities. Common diseaseshave their roots in life style, social factorsand the environment. Successful improve-ments in health must be based onpopulation strategies. It is far moreeffective to change the population meanlevels of risk (such as smoking habits orcholesterol level) rather than to tackle indi-viduals with high risk levels, as is envisagedin the concept of ‘vascular checks’. Popu-lation strategies are a far less attractivepublic relations option and are more dif-ficult politically, but would have a moreprofound effect in improving the levels ofhealth of the UK population.

In the most recent document for the pre-vention of CVD at population level issuedby the National Institute for Health andClinical Excellence (NICE) the draftguidance states “interventions focused onindividuals have tended to dominate CVDprevention activities. However, the largestoverall benefit could be achieved bymaking changes (albeit small ones) withinthe population as whole. As indicated bythe Rose hypothesis,27 a small reduction inrisk among a large number of people mayprevent many more cases, rather thantreating a small number at higher risk. Awhole-population approach explicitlyfocuses on changing everyone’s exposureto risk. This may be best achieved through‘upstream’ interventions: fiscal measures(including taxation), national or regionalpolicy and legislation (including, forexample, legislation on smokefree publicplaces or the way food is produced).

Social and economic action can also resultin a change in CVD risk (in such cases, thehealth outcomes are side effects – albeitdesirable). Voluntary action may beeffective. Sometimes, however, it may needto be supported by mandatory measures,for instance, when the pace of change isinsufficient. Data from ‘natural experi-ments’ in a whole population (where therewere no randomised controlled trials toassess the results) provide compelling evi-dence. One example is the reduction in theconsumption of animal fats in EasternEurope, following the break-up of theSoviet Union (29). Another example is theintroduction of legislation in Mauritius tomake it mandatory to use polyunsaturatedoils as a substitute for highly saturatedcooking oils. In such cases, there has beena remarkably rapid reduction in CVD

mortality among the populations.30 Con-versely, rapid rises in CVD mortality havebeen seen in China and elsewhere, princi-pally due to the adoption of a Western dietrich in saturated fats.31

Interventions which rely on peopledeciding to change their behaviour arelikely to vary in effectiveness. For example,people who are disadvantaged might findit more difficult to change than affluentpeople. As a result, some interventions thatfocus on changing behaviour may inadver-tently increase health inequalities. Toovercome this, the recommendations donot, in the main, rely on individual choicebut, rather, aim to make the healthy choicethe easy choice. Hence, the emphasis is onchanging policies, systems, regulations andother similar ‘upstream’ factors. Thisapproach is likely to reduce, rather thanincrease, health inequalities and is con-gruent with NICE’s guidance onbehaviour change.

The use of preventive health examinationsor multi-phasic screening may be justifiedfor populations that have few medical facil-ities, or organised health systems, toidentify those individuals who require careor treatment. In most developed countriesindividuals have easy access to health facil-ities so that benefits to improve thepopulation’s health through thesemeasures are difficult to identify. The occa-sional individual may benefit – but at thecost of harm to others. It is for this reasonthat WHO, US, Canada, the UK and otherhealth authorities have introduced clearprinciples by which screening measuresshould be assessed before introduction tomedical practice. PHE is an attractive com-mercial undertaking leading to theconsumption of drugs and the use of diag-nostic equipment. The stake that industryand advertising have is exemplified by theunscrupulous behaviour toward those whoare more questioning.28 It is also, superfi-cially, very attractive to the layman, afterall our cars have to be tested and examinedregularly to ensure that the engine andbrakes work. Thus health policy and politi-cians reacts favourably to such populistprocedures – but completely neglects thatall such examinations are fallible, leading tounnecessary further tests, the induction ofanxiety and to being ‘labelled’ ill.

REFERENCES

1. D’Souza MF. Early diagnosis and multi-phasic screening. In: Bennett, AE (ed). Recent Advances in Community Medicine.



London: Churchill, 1978.

2. Dobell H. Lectures on the Germs andVestiges of Disease, and on the Preventionof the Invasion and Fatality of Disease byPeriodical Examinations. London:Churchill, 1861.

3. Gould GM. A system of personal biologic examinations; the condition of adequate medical and scientific conduct oflife. Journal of the American Medical Association 1900;35:134–38.

4. Rosen G. Preventive medicine in theUnited States, 1900-1975. Trends and Interpretations. New York: Science History Publications, 1975.

5. Emerson H. Periodic medical examinations of apparently healthy persons. Journal of the American MedicalAssociation 1923;80:1376–81.

6. Council on Scientific Affairs. Medicalevaluation of healthy persons. Journal ofthe American Medical Association1983;249:626–1632.

7. Commission on Chronic Illness.Chronic Illness in the USA. Vol.1. Prevention of Chronic illness. Cambridge,MA: Harvard University Press, 1957

8. Breslow L, Roberts DW (eds). Screeningfor asymptomatic disease. Journal ofChronic Disease 1955;2:363–490.

9. Collen MF. The multi-test laboratory inhealth care of the future. Hospitals1967;41:119–25.

10. Pearse I, Crocker L. The Peckham Experiment. London: George Allen andUnwin, 1943.

11. Wilson JMG, Jungner G. Principles andPractice of Screening for Disease. Geneva:World Health Organization, 1968.

12. McKeown T (ed). Screening in MedicalCare: Reviewing the Evidence. Oxford:Oxford University Press for the NuffieldProvincial Hospitals Trust, 1968.

13. Various papers in a series on ‘Screeningfor disease’. The Lancet 1974;2.

14. Sackett D, Holland WW. Controversiesin the detection of disease. The Lancet1975;2:357–59.

15. Sackett DL. Screening for early detection of disease. To what purpose?Bulletin of the New York Academy ofMedicine 1975;51:39–52.

16. Knight AS. Value of periodic medicalexamination. Statistical Bulletin of Metro-politan Life Insurance Company 1921;2:1.

17. Roberts NJ, Ipsen J, Elsom KO, ClarkTW, Yanagawa H. Mortality among malesin a periodic health examination program.New England Journal of Medicine1969;281:20.

18. Cutler J, Ramcharan S, Feldman R, etal. Multiphasic checkup evaluation study.I – Methods and population. PreventiveMedicine 1973;2:197–206.

19. Ramcharan S, Cutler JL, Feldman R, et al. Multiphasic evaluation study. 2. Disability and chronic disease after sevenyears of multiphasic health check-ups. Preventive Medicine 1973;2:207–20.

20. Olsen DM, Kane RL, Procter PH. Acontrolled trial of multiphasic screening.New England Journal of Medicine1976;294:925–30.

21. Lannerstad O, Sternby NH, IsacssonSO, Lindgren G, Lindell SE. Effect of ahealth screening mortality and causes ofdeath in middle-aged men. ScandinavianJournal of Social Medicine 1977; 5:137–40.

22. South East London Screening StudyGroup. A controlled trial of multiphasicscreening in middle-age: results of theSouth-East London Screening Study. International Journal of Epidemiology1977;6:357–63.

23. Ren A, Okubo T, Takahashi K. Com-prehensive periodic health examination:impact on health care utilisation and costsin a working population in Japan. Journalof Epidemiology and Community Health1994;48:476–81.

24. Boulware EL, Marinopoulos S, PhillipsKA et al. Systematic review: the value ofthe periodic health evaluation. Annals ofInternal Medicine 2007;146:289–300.

25. Which? check-ups on private healthMOTs. Which 2009;August:20–23.

26. Spence D. When it’s worth repeating.British Medical Journal 2009;339:244.

27. Rose G. The Strategy of PreventiveMedicine. Oxford: Oxford Medical Publications, 1992.

28. Holland WW, Stewart S. Screening inDisease Prevention, What Works?Abingdon: Radcliffe Publishing, 2005.

29. Zatonski WA, Willett W. Changes in dietary fat and declining coronary heartdisease in Poland: population based study.British Medical Journal 2005;331:187–89.

30. Dowse GK, Gareeboo H, Alberti KGet al. Changes in population cholesterolconcentrations and other cardiovascularrisk factor levels after five years of the non-communicable disease interventionprogramme in Mauritius. British MedicalJournal 1995;311:1255–59.

31. Critchley J, Liu J, Zhao D, Wei W,Capewell S. Explaining the increase incoronary heart disease mortality in Beijingbetween 1984 and 1999. Circulation2004;110:1236–44.



Nordic Health Care SystemsRecent reforms and current policychallenges

Jon Magnussen, Karsten Vrangbaek and Richard B. Saltman

Published by Open University Press

339 pages

The Nordic model of health care systems is assumed to contain consistentfeatures across all five Nordic countries: tax-based funding, publicly ownedand operated hospitals, universal access based on residency and comprehensive coverage. The reality is considerably more complex, with greatvariation at the structural level in the way that institutions are designed andat the policy level in the way strategies are conceived and implemented.

This book examines recent patterns of health reform in Nordic health care systems, including the balance between stability and change in how thesesystems have developed. Detailed comparisons are undertaken along a variety of policy-driven parameters.

Freely available at: www.euro.who.int/observatory/Studies/20091021_2

http://www.euro.who.int/observatory/Studies/20091021_2



On 22 July 2009, the European Com-mission announced the allocation of EUfunds to the twenty-two Member Statesparticipating in the ‘School Fruit Scheme’(SFS).1 This is a landmark decision forpublic health because for the first time, akey EU policy has integrated public healthinterests as an implicit policy objective.

The SFS aims to improve children’s dietsby sustainably increasing the consumptionof fruit and vegetables through the creationof healthy eating habits. Increasing fruitand vegetable consumption is a publichealth priority as defined by the WorldHealth Organization (WHO)2 and by theEU.3,4 Specifically, the EU SFS targetschildren early in life by increasing accessi-bility to fruit and vegetables in schoolenvironments.

As of September 2009, there will be anannual budget of €157M (of which €90M(57%) are Community funds) available toMember States to provide fruit and veg-etables as part of a newly established orexpanded SFS. The EU funds will comefrom within the Common Agriculture

Policy (CAP), one of the core competenceareas of the EU with a long history andsubstantial funds.5

Public health objectivesFor the first time, the rather general Article152(1) of the Treaty requiring “a high levelof human health protection in all Com-munity policies” is implicitly used toestablish a concrete and well-funded policymeasure within an EU mainstream policy,the CAP. The sustainable increase ofdemand for fruit and vegetables by cre-ating healthy eating habits in children doesnot merely aim at increasing quantity (i.e.,calories from agricultural produce) butalso at improving the quality of children’sdiet with the long term goal of improvingpublic health. In contrast, other EU agri-culture policy measures, such as SchoolMilk and Food Aid to Most DeprivedPersons (MDP), were originally created todispose of surplus products in order torelieve the respective markets, and havefailed to address public health goals.

The SFS, on the contrary, is driven by

demand: Member States’ competentauthorities are given funding to purchaseproducts of their choice on the market.Eligible products are defined as all freshand processed fruit and vegetables,including tropical fruit and bananas fromthird countries. Products that containadded sugar, salt or fat are not eligible, andproducts incorporated in national schemesmust be approved by a competent MemberState health authority. This clearly givespriority to health objectives, compared toother schemes that give priority to marketimpact objectives.

Furthermore, accompanying measuresmust be defined by Member States in orderto receive funding. Accompanyingmeasures aim to proactively integrateparents and teachers and link the schemeto public health, education and agriculturein a comprehensive effort to create envi-ronments that support healthy eatinghabits in children. Although thesemeasures receive no direct EU support,they are to be defined in the strategyclearly demonstrating their contribution tothe scheme’s overall objectives.

A key element of the policy management isthe ‘Strategy’, which must be developedfor each geographical level, i.e. national,regional or municipal, for which therespective Member State chooses to createa SFS. Only a limited number of criteriaare obligatory, such as the budget,

The EU School Fruit Scheme: Integrating public health into mainstream policy

Felix Mittermayer and Robert Pederson

Summary: Public Health is often considered as a European Union (EU) policy, which lacks immediate tools and funds to deliver concrete results to Europe citizens.One way forward to broaden the approach of public health within the framework of EU policies is to integrate its objectives into mainstream policies. A prime exampleof placing public health interests into other policy areas is the recently launched‘School Fruit Scheme’ which, although small as a programme, offers the opportunityto establish public health objectives within one of the longest running and bestfunded EU policies – the Common Agriculture Policy.

Key Words: Common Agriculture Policy, Europe, European Commission, diet, publichealth

Felix Mittermayer is Policy Analyst at DG SANCO/02, European Commission and previously worked in DG AGRI on the EU School Fruit Scheme from its inception.

Robert Pederson manages the European Agriculture and Health Consortium (EAHC), a Brussels-based alliance of health organisations whose main aim is to advocate for healthpromoting agriculture policy.

Email: [email protected]


duration, and target group, a list of eligibleproduce, stakeholders and accompanyingmeasures of a SFS.

Strategies have a dual purpose: to ensurethat programmes meet the objectives setforth by the Commission and to provide aframework for evaluation and comparingMember State schemes. Strategies aremulti-annual, providing a sustainableframework and avoiding short termpolitical and budget constraints to ade-quately combat the long term problemsassociated with poor nutrition and obesity.

The ‘Strategy’ itself is not formallyapproved by the Commission but sub-mitted for information and publication.The main objective of this document istherefore not to fulfil a legal obligation butrather to initiate an internal discussionprocess in the respective Member States,bringing together the relevant stakeholdersand sectors to agree on a sustainableframework for a long term approach.

Public health in implementationPublic health experts and stakeholdershave played an important role in the designof the SFS. They will continue to do so asthe programme is implemented. First, thedesign process offered the opportunity toopen up existing Commission platformsfor interaction with the agriculture sector(producers, trade and industry) to includepublic health stakeholders and experts.This increased cooperation was high-lighted during a major conference, drivenlargely by pubic health expertise, inDecember 2008 in Brussels, entitled:School Fruit: a healthy start for ourchildren – Promoting School Fruit Schemesin the European Union.

Currently, this cooperation is being insti-tutionalised with the creation of apermanent expert group to shadow themanagement and implementation of theEU-wide SFS. This tool will provide tech-nical expertise, i.e., methodology forevaluation and monitoring of the SFS. Atthe same time, it will ensure that the effec-tiveness of Member States’ schemes withrespect to the overall objective ofimproving public health is maintained.

Compared to other voluntary schemes, theSFS has a high uptake, twenty-two oftwenty-seven Member States are imple-menting the scheme. Throughout thepolicy development process transparentcommunication was used, both as an endand as a means. On the one hand, to raiseawareness for the proposal and the under-

lying problem, as well as on-going initia-tives in the Member States, andconsequently to create public support forthe proposal. On the other hand, it aims tocreate positive peer pressure on MemberStates by publishing all relevant docu-ments, notably the Strategies as well asmonitoring and evaluation reports. Theinterested public will thus be able to judgefor themselves about the effectiveness ofthe scheme in their respective MemberStates. In addition, this transparency willfacilitate the comparison of schemesbetween Member States and foster thedevelopment of best-practice examples.

Unfortunately, recently publishedstrategies illustrate several problems at EUand Member State levels. The strategies aredifficult to understand and comparebecause a standardised format is not usedand strategies are only published in theMember State’s language. Publishedstrategies also indicate problems with eli-gible products, and may require a strongerdefinition of eligible or non-eligibleproducts by the Commission. Ironically,Greece has only includes processed fruitand juice in its programme, which contra-dicts the original goal of the programme,to increase the consumption of fruit andvegetables.

Establishing both expert and stakeholdergroups to address these issues should be apriority to ensure the programme is suc-cessful and effective in meeting its goals.Even more so, transparency and accounta-bility of the SFS should remain as anunderlying principle and be ensured by anoverall evaluation to be undertaken byindependent contractors. The results ofthis exercise will be reflected in theassessment report from the Commission tothe European Parliament and the Council,which is due in August 2012.

Perspectives The discussion on the future allocation ofEuropean funds will take place withinbudget negotiations for the next seven-year financial framework 2013–2021.These are expected to start in earnest in2011, corresponding to when the SFSassessment report is to be published.

Within the EU budget negotiations, theCAP funds will play an important role:similar to the process in the 1980s, whenthe CAP started to reflect the environ-mental impact of agriculture production,the focus today is increasingly on theimpact of agriculture production onhuman health. However, quality is still

mainly defined in terms of quality of pro-duction. Human health is not a criterion inestablishing EU funding in investmentsupport or direct payments.

However, public health could be a crucialpartner in delivering legitimacy to con-tinued CAP funding for European farmersthrough the creation of a full-fledged EUfood quality policy6 with the objective ofreconciling quality of production withquality of consumption for food. Thiswould require creating a horizontalapproach within the EU’s agriculturepolicy to enhance quality and diversitythroughout the whole food chain, ensuringa positive health impact and the highestpossible food safety standards for all agri-culture products deemed fit for humanconsumption.

Consequently, the EU SFS, although smallin budgetary terms and limited in objec-tives, is a first attempt at integrating publichealth objectives within a programmedirectly linked to the market managementmeasures within CAP. The programmeshould not be seen as a small, one off pro-gramme, but rather as a catalyst that has setin motion long term changes within theCAP, introducing public health, with itsstakeholders, their perspectives and newapproaches, as an integral part of the main-stream (agriculture) policy.

REFERENCES

1. European Commission decision 5514 final of 22 July 2009.

2. World Health Organization. Diet, Nutrition and the Prevention of ChronicDiseases. Report of a Joint WHO/FAO Expert Consultation. Geneva: WorldHealth Organization, 2003.

3. Commission of the European Communities. EURODIET Core Report.Brussels: EC Directorate General Healthand Consumer Protection, 1998.

4. Commission of the European Communities. White Paper on a Strategyfor Europe on Nutrition, Overweight andObesity related health issues. COM(2007)279 final. Brussels: European Commission,2007.

5. Mittermayer F. Increasing the consump-tion of fruit & vegetables by school chil-dren: which role for the European Union?ISHS Scripta Horticulturae 2008; 8:79–94

6. Commission of the European Commu-nities. Communication on AgriculturalProduct Quality Policy. COM(2009) 234 fi-nal. Brussels: European Commission, 2009.





In Wales, the National Service Framework(NSF) for Older People (Box 1) sets outevidence-based standards for the healthand social care of individuals aged overfifty years. This article provides anoverview of progress made on the NSF asan exemplar of the challenges of policydevelopment and implementation within aWelsh context, including the devolution ofhealth system responsibilities. As aframework for analysis it considers factors,which if not addressed, may lead toresistance to policy implementation.

Policy development and implementationThe development of evidence-based healthpolicy is challenging1 and balances anumber of factors which have the potentialto be in tension with each other. One ofthese factors is the hierarchy of evidence,2

ranging in strength from meta-analysis ofrandomised controlled trials (RCTs)through to the opinion of respectedauthorities. Balanced against this hierarchy,however, is the practical consideration that

some situations do not readily lend them-selves to RCTs being conducted.3 Inaddition, a strong case for policy devel-opment may sometimes be made usingevidence from sources other than RCTs,4

such as observational studies. The ethics ofdelaying policy implementation in thesesituations has been questioned with thestatement that “waiting for the results ofrandomised trials of public health inter-ventions can cost hundreds of lives….if thescience is good, we should act before trialsare done”.4

A further issue to be considered in thedevelopment and implementation ofpolicy is the need to take account of localrealities5 and resistance factors to policychange.6 Specific resistance factors havebeen described in a case study from theUkraine about the control of tuberculosis.Health service financing and paymentsystems, coupled to opposition frompolicy makers and clinicians, appear tohave combined to create a set of circum-stances which has underminedtuberculosis control programmes beingproperly implemented in this country.6

More generally, it has been suggested thatthe failure to fulfil six factors may lead toresistance to policy change.7 These are: (i)the importance and value of having multi-disciplinary teams; (ii) the need to have abroad evidence base to draw upon; (iii) the

circular relationship between research andpolicy; (iv) the need for policy implemen-tation to be locally sensitive; (v) the benefitof stakeholder involvement; and (vi)support by the national government.

Taking the last of these factors, gov-ernment administrations differ in the waythey are constituted and their powers. InWales, which is one of the constituentcountries of the United Kingdom with apopulation of nearly three million resi-dents, devolution in 1999 transferred arange of policy responsibilities, such as theNational Health Service (NHS), to anAssembly of democratically electedmembers.8 Greater political powers to allof the nations of the United Kingdom inthe last ten years have led to divergence inhealth policies .9 In Wales, there has been adrive to improve the cohesion betweenhealth and social care organisations.10 Inparticular Wales has been particularlyactive in the provision of services to olderpeople. In addition to implementing theten year NSF for Older People, otherexamples include introducing a Com-mission for Older People.

The importance and value of multi-disci-plinary teamsThe NSF for Older People in Wales isdelivered by twenty-three partnerships,constituted on twenty-two local authority

Policy development and implementation: The National Service Framework for Older People in Wales

Gareth Morgan

Summary: In Wales, the National Service Framework (NSF) for Older People setsout evidence-based standards for the health and social care of individuals age overfifty years. Launched in 2006, this ten year programme has made progress in the firstthree years but further work is needed. This paper offers an overview of the NSF todate using a framework of six policy factors. This overview is discussed within a context of the challenges of policy development and the situation in Wales, includingdevolvement.

Key words: implementation, National Service Framework, older people, evidence-based health policy, Wales

Gareth Morgan is Project Manager, National Service Framework for OlderPeople. The post is supported by Welsh Assembly Government and hosted byHywel Dda Health Board, Llanelli,Wales. Email: [email protected]


areas and one all-Wales service whichdelivers national programmes, such ascancer screening. The twenty-two localpartnerships include health and social careservices, both statutory and non-statutory.

The partnerships vary in their size, consti-tution, frequency of meetings, reportingarrangements and internal cohesion. All ofthese factors may influence the NSFimplementation and a small number ofpartnerships have been compromised byinter-organisational and inter-personal ten-sions.

Establishing multi-disciplinary teams perse therefore appears insufficient for properpolicy implementation and robust profes-sional relationships are also required. Suchrelationships take time to develop andappear to be compromised by factors suchas staff turnover and organisational

re-structuring. In Wales, the NHS is cur-rently undergoing a major reform leadingto greater regional working and an abol-ishing of the internal market.

The need to have a broad evidence baseto draw uponThe evidence underpinning each of thediverse NSF standards is broad and wasinitially compiled through systematicsearches of the literature. The importanceof this broad evidence base is that it offersa robust approach to policy development.Furthermore, the implementing partner-ships across Wales can also haveconfidence in the NSF as a quality andcontemporary framework for servicedelivery.

Of course, the underpinning evidence basecontinues to progress and evidence-based

digests are disseminated across Wales,through a monthly Current AwarenessBulletin and a quarterly Newsletter. Theinterest shown in these digests by the part-nerships varies and a more systematicapproach to converting new evidence intopractice across Wales could be considered.Such evidence is derived from a range ofsources including the literature and alsoprofessional experience. On the latterpoint, the SAAT is an open reportingsystem allowing partnerships across Walesto review the NSF implementation inother areas.

The circular relationship between re-search and policyResearch can take many forms and fromthe outset of the NSF there has alwaysbeen an intention for an independentreview to be conducted on progress beingmade. This review is currently underwayby Health Inspectorate Wales (HIW) andCare & Social Services Inspectorate Wales(CSSIW). The review, the first one under-taken jointly by the inspectorate agencies,will report later in 2010 and will inform thepolicy direction of the NSF between 2011and 2016.

The review is being driven by the question:What impact has the NSF for OlderPeople had in Wales? Three cross cuttingthemes will be evaluated, namely dignityin care, nutrition and integrated services.The inspection agencies have consultedwith key groups, such Age Alliance Wales(which consists of voluntary organisations)and Care Forum Wales (who represent theindependent care home sector), about howbest to engage with key stakeholders, suchas service users and their carers, as part ofthis review.

The need for policy implementation to belocally sensitive In Wales, there is variation in the popu-lation sizes of local authority areas, fromabout 50,000 to 250,000. Variation alsoexists in terms of population demography,health profiles and service availability. Forexample, the valley communities in SouthWales, former sites of heavy industry suchas coal mining, are characterised by a highprevalence of long term chronic conditionsand a life expectancy less than the Welshaverage. The implementation of the NSFin these areas will differ from a large localauthority in mid Wales, which borders theEnglish midlands, in which there are chal-lenges of a mainly rural population.Language issues are also a factor, for



Box 1 : Summary of the NSF for Older People

The NSF for Older People was launched in March 2006. It sets out evidence-based standards forthe delivery of high quality health and social care services in Wales. It was developed with the advice and support of a wide range of stakeholders, including older people. Phase one of the NSFcovered the first three years to April 2009 and has primarily set down the structures and foundations underpinning the long term implementation of this programme until 2016.

The NSF is based on eleven standards which address specific service areas, such as stroke, as wellas challenging cross cutting themes, such as rooting out age discrimination:

Standard 1 Rooting out age discrimination

Standard 2 Person centred care

Standard 3 Promotion of health and wellbeing

Standard 4 Challenging dependency

Standard 5 Intermediate care

Standard 6 Hospital care

Standard 7 Stroke

Standard 8 Falls and fractures

Standard 9 Mental health

Standard 10 Medicines in older people

Standard 11 Workforce development

The Self Assessment Audit Tool (SAAT) is an internet based reporting system which is used as oneof the systems to monitor the NSF implementation. The SAAT, which has strengths and weaknesses,offers evidence that implementation against the phase one targets and milestones for the standardshave been largely achieved across Wales. There is, however, variation across Wales within thisoverall picture and there is further work to do in a number of areas.

For example, the implementation of the mental health standard appears wide ranging acrossWales. The developing Dementia Action Plan in Wales will be helpful to progress this standard further forward. There are also issues of information sharing that have challenged the NSF implementation. Different organisational boundaries and information technology systems betweenhealth and social care services have resulted in difficulties in capturing all pertinent evidence. Thisexperience perhaps illustrates a wider issue of collaborative working in the provision of integratedservices; although in Wales this is mitigated to some extent by an increasing drive toward jointcommissioning of services.

example areas in the mainland and the twoislands of North West Wales have a highnumber of speakers for whom Welsh is thefirst language of choice.

The benefit of stakeholder involvementAs well as the independent review, there isa close working relationship between theWelsh Assembly Government and thetwenty-three partnerships across Wales.This includes quarterly meetings held on aregional basis, namely Mid and SouthWest, South East and North Wales. Thesemeetings provide a forum for all aspects ofthe NSF to be discussed and debated by agroup of professional stakeholders whoare implementing the standards.

In addition, an Implementation AdvisoryBoard convened by the Welsh AssemblyGovernment oversees the implementationof the NSF. This Board consist of Gov-ernment civil servants, representatives ofolder people from groups such as theNational Partnership Forum for OlderPeople in Wales, academic institutions,local authority umbrella groups, healthorganisations and other partners such asvoluntary sector providers. Whilstacknowledging the debates and differencesof opinion that occur, the engagement withall pertinent stakeholders offers a platformfor the progression of the NSF.

Support by the national governmentIn Wales, the Deputy Minister for Healthand Social Service, Mrs Gwenda Thomas,AM (Assembly Member), takes the leadfor issues relating to older people. MrsThomas receives briefings on all aspects ofthe NSF and regularly answers correspon-dence. In addition, the National Dignity inCare programme in Wales, which ismanaged as part of the NSF, was initiatedby Mrs Thomas in October 2007. Mostrecently, £100,000 has been set aside by theWelsh Assembly Government toimplement a programme of dignity in caretraining across Wales. This training may beconsidered to be an integral part of work-force development in Wales. The supportby the Welsh Assembly Government istherefore crucial in allowing the NSF toprogress in Wales.

ConclusionsIn the first three years of the NSF forOlder People in Wales, progress has beenmade but challenges remain. These includespecific service areas and also the need toimprove data collection across organisa-tional boundaries. Interestingly, no specificadditional money was introduced with the

NSF, contrasting with the situation on theNSF for children, yet this per se has notbeen a barrier to implementation since theNSF is about an integrated and holisticapproach to health and social care pro-vision. Given that the population is ageingand the financial challenges facing society,a holistic approach offers advantages ofefficient and effective services.

References

1. Kemm J. The limitations of ‘evidence-based’ public health. Journal of Evaluationin Clinical Practice 2006;12(3):319–24.

2. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy ofresearch designs. New England Journal ofMedicine 2000;22(25):1887–92.

3. Smith G, Pell JP. Parachute use to prevent death and major trauma related togravitational challenge. British MedicalJournal 2003;327:1459–61.

4. Potts M, Prata N, Walsh J, Grossman A.Parachute approach to evidenced based

medicine. British Medical Journal2006;333:701–3.

5. Potter C, Harries J. The determinants ofpolicy effectiveness. Bulletin of the WorldHealth Organization 2006;84(11):843.

6. Morgan G. Evidence based health policy: A preliminary systematic review.Health Education Journal (in press).

7. Atun R, Olynik I. Resistance to implementing policy change: the case ofthe Ukraine. Bulletin of the World HealthOrganization 2008;86(2):147–54.

8. Drakeford M. Health policy in Wales:Making a difference in conditions of difficulty. Critical Social Policy2006;26(543):543–61.

9. Greer S. Devolution and divergence inUK health policies. British Medical Journal2009;338:78–80.

10. Jewell T, Wilkinson J. Health and socialcare regulation in Wales; an integrated system of political, corporate and professional governance for improvingpublic health. Journal of the Royal Societyfor the Promotion of Health2008;128(6):306–12.



Health in the European Union:Trends and analysis

Philipa Mladovsky, Sara Allin, Cristina Masseria,Cristina Hernández-Quevedo, David McDaid andElias Mossialos

Copenhagen: World Health Organization on behalfof the European Observatory on Health Systems andPolicies, 2009. 164 pages.

This new report investigates differences in health status within and betweenEuropean countries. The relationship between living conditions, socio-economic factors and health is discussed and analysed with the objective of stimulating a debate and policy action for creating a healthier and more equitable society.

The range of living conditions in the European Union has widened tremendously in recent years and will continue to do so. This diversity hastranslated into varied patterns of health across the region. Public health hasbeen affected by inequalities in income, education, housing and employment.

The picture that emerges from this review is one of significant improvementsin most countries; however considerable challenges remain in the context ofan increasingly diverse and ageing population in Europe.

Freely available at: www.euro.who.int/observatory/Studies/20100201_1

http://www.euro.who.int/observatory/Studies/20100201_1



On 19 May 2009, the European Court ofJustice (ECJ) ruled against the freedom ofestablishment of community pharmacies inGermany.1 The court case, which lasted forthree long years, was questioning the 800-year old German Pharmacies Act2 underwhich only registered pharmacists mayoperate a pharmacy – with a maximum ofthree branches; hence, pharmacy chainscontinue to be banned while pharmacistscontinue to enjoy their monopoly.Germany is not the only country in Europewith regulations limiting pharmacy own-ership: Austria, Spain or Hungary3 havebeen cited by the German government andprofessional associations alike. At the otherend of the spectrum, countries includingthe Netherlands, Ireland and the UK3

hardly restrict ownership although it ismandatory that a pharmacist, as anemployee, is always present and supervisesthe dispensing of prescriptions.

Why regulate community pharmacies?Pharmacists play a key role in the deliveryof health care. They are responsible for

checking and filling prescriptions and tra-ditionally have been involved in theproduction of patient-specific preparations.With the growing importance of the over-the-counter (OTC) segment of the marketand of self-medication, they are increas-ingly acting as health advisers providingcounselling to patients. Thus, their range ofservices covers not only pharmaceuticalspecialities but also a number of pharma-ceutical services to patients including, forexample, health promotion activities. As aresult of the relevant role that pharmacistsplay in the delivery of health care, com-munity pharmacies in the majority of thecases are highly regulated in most MemberStates of the European Union (EU). Keyareas of regulation relate not only to own-ership issues (for example, limitation ofownership to pharmacists, and limits to theownership of multiple pharmacies pro-hibiting pharmacy chains) but also to theestablishment of pharmacies (for example,a needs assessment, or demographic/geo-graphic regulations); registration andlicensing issues; distribution of pharma-ceutical products outside a pharmacy;opening hours; and pricing, remunerationand incentives issues, given that gov-ernment backed health insurance or generaltaxation is the key payer of these services.

Member States and stakeholders justifythese restrictions claiming that they ensurethe independence of the service providerand facilitate access to pharmaceuticals,whilst guaranteeing equity, quality and safeprovision of pharmacy services. Theserestrictions can result in a monopoly forpharmacists. Governments claim to usereimbursement and incentive mechanismsas a mechanism to counter the ineffi-ciencies of such monopolies.

The OECD in its 2001 report on Regu-latory Reform in Ireland contested thelogic of these regulations.4 It argued thatthe creation of a protected monopoly tocross-subsidise unprofitable activities wasnot the right solution. In fact, keeping upwith competitors is what usually stimu-lates quality-improving services. This cameabout at a time when the debate on thederegulation of public services was takingplace in several EU Member States.3 Oneof the sectors receiving attention washealth care, including community phar-macies. The rationale behind deregulationin the pharmacy sector is the expectationthat liberalisation will increase competitionand thus succeed in lowering, or at leastcontaining (public) expenditure, whileaccess to quality pharmacy services will

Are regulations of communitypharmacies in Europe questioningour pro-competitive policies?

Maria Lluch

Summary: Drawing on a recent European Court of Justice ruling against the freedomof establishment of community pharmacies in Germany, this article addresses the tensions in European health care systems that arise between regulating communitypharmacies and striving for competition in order to stimulate better quality services.It spans the different types of policies that are currently applied to community pharmacies – restrictions on ownership; restrictions on establishment; registration and licensing; restricting distribution to pharmacy outlets; limiting opening hours;and incentives (pricing and reimbursement) – and provides experiences on the impactof (de)regulation in different Member States. The author concludes by raising someof the trade-offs when (de)regulating community pharmacies in general and advocates for liberalising ownership, in particular.

Keywords: pharmacies, Europe, regulation, competition

Maria Lluch is reading for a PhD, LSEHealth, London School of Economics andPolitical Science. Email: [email protected]


remain stable, if not improved, by theopening of new outlets. In sum, deregu-lation claims to make the market moreefficient whilst key areas like equity andaccess are not compromised.

Together with deregulation in a number ofareas of the public sector, the regulation ofcommunity pharmacies in Europe wasquestioned at European Commission3 andMember State levels.5 Advocates of dereg-ulation, such as the Office of Fair Tradingin the UK or the Internal Market andServices Directorate General at EU level,argued that it would stimulate competitionand improve efficiency. Opponents ofderegulation, such as the Consejo Generalde Colegios Oficiales de Farmaceuticos(CGCOF)6,7 in Spain, or PharmaceuticalGroup of the European Union8 at EUlevel, claimed that liberalising communitypharmacies would potentially be detri-mental to the delivery of quality services.

The recent ECJ ruling1 recognising thatthe rules on ownership and operation ofpharmacies can be restricted to pharma-cists has only spiced up the debate.

Implications of ownership restrictionsA common set of values for Europeanhealth care systems – universality, access togood quality care, equity and solidarity9 –are the pillars resulting from the healthacquis communautaire, hence, MemberStates and any institution within the EUwould strive to ensure that those are pre-served before implementing any policy,act, ruling or recommendation.

Some of the restrictions imposed on com-munity pharmacies may be justified to acertain extent. For example, Spain regulatesthe location for the establishment of phar-macies, guaranteeing access andgeographical equity, to 99% of the popu-lation,10 whilst in England more relaxedregulations it is claimed offer access to (anarguably inflated) 96% of the population.11

One may therefore contend that regulationin Spain does more good than harm byensuring a very high level of coverage.

In contrast, some restrictions are not nec-essary for guaranteeing the right to healthcare. Restrictions on pharmacy ownershipmay be one example. Advocates forrestricting ownership claim that it has anpositive impact on the quality of healthcare delivery. Clearly, the presence of apharmacist is required to ensure quality ofcare12 but this is a completely differentissue from ownership. There is no evidenceproving the association between own-

ership and quality of care; in a communitypharmacy, quality of care is guaranteedsimply by the presence of a pharmacist.

Liberalising the system by divorcing own-ership from pharmaceutical activity, thuseliminating restrictions on ownership,therefore may have different implications.The immediate implication is the greaternumbers of pharmacy chains, not neces-sarily being owned by pharmacists. Theseare often associated with operational effi-ciencies. Moreover, evidence from the UK5

and Iceland13 indicates that liberalising themarket can stimulate competition,including price competition on OTC drugswith consequent benefits for society. At alater stage, market consolidation and ver-tical integration may take place, as hasoccurred in Norway13 or in the UK in thecase of the takeover of Boots by AllianceUnichem. In the long-run this may run therisk of oligopoly, given that a small numberof chains would be the principal players inthe field. This would mean that pharmacistsas professionals would lose their monopolybut another type of monopoly wouldappear. Although it seems reasonable toeliminate restrictions in ownership, othertypes of mechanism should be designed tocounter too high a degree of market domi-nance by pharmacy chains.

Liberalisation also has implications forother stakeholders, such as pharmacist pro-fessional associations. In countries whereownership is regulated, these associationsplay a key role. Governments may delegatethem the power to ensure that the rules areimplemented appropriately. Spain offers amarvellous example in this case. TheCGCOF represents the interests of allpharmacists holding a license, as well as theinterests of community pharmacy ownersand ensures that regulations are respected.Thus professional, commercial and tradeinterests, health care priorities and legalissues all fall within the ambit of one insti-tution. In liberalised markets, as in the UK,there are two institutions in the field eachwith a different role. The Royal Pharma-ceutical Society of Great Britain is theprofessional and regulatory body for phar-macists and pharmacy technicians inEngland, Scotland and Wales; the primaryobjectives of the Society are to lead, reg-ulate, develop and represent the professionof pharmacy. The National PharmacyAssociation is the trade association forcommunity pharmacy owners and has vir-tually all community pharmacies enrolledwithin its membership. The Associationprovides its members with professional and

commercial support, as well as representingthe interests of community pharmacy indialogue with Government, both at anational and European level. In the light ofthese two realities, it is not difficult tounderstand why entities such as CGCOFdo not support liberalising ownership.

The impact of liberalising the ownership ofcommunity pharmacies on other stake-holders beyond pharmacy owners orchains and professional pharmacy associa-tions is unlikely to be negative.Pharmacists would still be required behindthe counter, and as far as this happens, thequality of care is unlikely to suffer: patientswill receive at least the same quality ofcare. If price competition on OTCs is alsoevident then there may be additional ben-efits for society.

ConclusionsEuropean health care systems need to finda balance between the values they are com-mitted to – solidarity, equity, availabilityand access to health care – while strivingfor efficiency and competition, providingoptions that benefit the society and helpcontain health care expenditure, in par-ticular to meet the challenge of anincreasingly ageing population. Restrictingownership has not proven to be a threatthose European values, whilst they seem toimprove efficiency and competitiveness.

This piece of research, although aimed atthe European level, has provided anoverview of experiences from severalMember States. More research includinganalysis of in-depth experiences of the dif-ferent models in operation in all MemberStates, looking at each type of restrictionand reform in the field of community phar-macies, is needed to take the case further.

The ECJ ruling1 stated that “Articles 43EC and 48 EC do not preclude nationallegislation, such as that at issue in the mainactions, which prevents persons not havingthe status of pharmacist from owning andoperating pharmacies”. It should not beconcluded that the ECJ wants to preservea regulation that makes our health caresystems less competitive or that the ECJ isagainst pro-competitive policies as far asthe health acquis communautaire is notthreatened; it only means that often theECJ tends to avoid ruling against MemberState legislation, in particular when thereare further implications to be addressedbefore liberalisation is achieved. Despitethis, steps in the form of recommendationsand later on European directives should be encouraged to ensure the efficiency


HEALTH POLICY DEVELOPMENTS



The 1999 health care reformsIn 1999 Poland went through a series ofsocial sector changes, which constituted a‘second wave’ of reforms in the transitionto capitalism. These changes includedhealth, pensions, education and territorialadministration.

The health care reforms introducedchanges in the mechanism of financing laiddown in the 1997 Law on UniversalHealth Insurance which came into force inJanuary 1999. This introduced a system offinancing based on the Bismarckian socialinsurance model, whereby insurance fundsare raised from a compulsory deductionfrom taxable income, originally set at7.5%. The rate was raised followingdebates, increasing by 0.25% annuallybetween 2003 and 2007 until it reached itscurrent level of 9%.

The insurance funds were designed tofinance the direct costs of health servicesto patients through contracts betweenservice providers and purchasers. Thelatter originally took the form of sixteenRegional Sickness Funds (kasy chorych),one in each of the new voivodeships(regions), together with one Sickness Fund

for uniformed services. Following criti-cisms, the sickness funds were replaced in2003 by a recentralised National HealthFund (NFZ – Narodowy FunduszZdrowotny). This performed largely thesame functions and had a branch in eachvoivodeship.

The original decision to set the premiumat 7.5% of taxable income had a criticaleffect on the subsequent provision ofhealth care. The figure represented a sub-stantial reduction on the level of 10%advocated by health care professionals andthe 10%–11% that had also been men-tioned in earlier bills.1 The issue had beenvigorously contested during the first halfof 1998, with the action committeeKOROZ (The Committee for the Defenceof Health Care Reform – Komitet ObronyReformy Ochrony Zdrowia) being formedat this time.

Given that the income base from whichpremiums were deducted was low, withmany of those in employment on modestlevels of pay and about one-fifth of theworking population officially unemployedat the time, the decision resulted in a sharpdrop in the public funding available forclinical care.2 Health care funding waspushed below 4% of Gross DomesticProduct (GDP). Coupled to the fact thatPoland had one of the lowest GDP percapita rates in Europe, this represented avery modest level of funding indeed.3 The

Summary: Hospital privatisation has been highly contentious and has progressed slowly in Poland. Shortly after winning the 2007 elections, the Civic Platform Party proposed legislation for compulsory, universal and totalhospital privatisation. The law was passed by Parliament but later annulled by presidential veto and a fall-back plan for optional hospital privatisation put in its place. This came into force in April 2009. However, the economic crisis hasplaced a question mark against the new programme. This article outlines the social processes involved in the privatisation of hospitals since the introduction in 1999 of major health care reform.

Keywords: debt, social dialogue, economic crisis, protest, Poland

Peggy Watson is at the Homerton College, Department of Sociology PPSIS,University of Cambridge. Email: [email protected]

and competitiveness of our health caresystems. However, when formulating pro-competitive policies, risks associated withover-monopoly should also be addressed,preferably avoiding ad-hoc interventions,as has been learnt from experiences inNorway and Iceland.

REFERENCES

1. Joined Cases C-171/07 and C-172/07.Reference OJ C 140 of 23.06.2007, p.11:ECJ, 19/09/2009.

2. Förster A. Germany’s Pharmacy SceneRemains a Patchwork. Munich: Goethe Institut, 2009.

3. Volkerink B, de Bas P, van Gorp N,Philipsen N. Study of regulatory restrictions in the field of pharmacies.ECORYS Nederland BV in cooperationwith METRO – University of Maastricht. Rotterdam: ECORYS, 2007.

4. OECD. Regulatory Reform in Ireland:The Role of Competition Policy in Regulatory Reform. Paris: OECD, 2001.

5. OFT. The Control of Entry Regulationsand Retail Pharmacy Services in the UK.London: Office of Fair Trading, 2003.

6. CGCOF. Argumentario modelo españolde farmacia. [The case for the Spanishpharmacy model] Madrid: Consejo General de Colegios Oficiales de Farmacéuticos, 2006.

7. CGCOF. Los Modelos de Farmacia en laUnión Europea [Models for pharmacy inthe European Union]. Madrid: ConsejoGeneral de Colegios Oficiales de Farmacéuticos, 2007.

8. PGEU-Secretariat. PGEU contributionto the internal market consultation. Brussels: Pharmaceutical Group of the European Union, 2006.

9. Rys A. The contribution of ICT to themodernisation of European health systems.The European files: eHealth in Europe.Brussels: European Commission, 2009.

10. Portalfarma. La farmacia en España.[Pharmacy in Spain] Madrid: Consejo Gen-eral de Colegios Oficiales de Farmaceuticos, 2008.

11. Galbraith A. Review of NHS Pharmaceutical Contractual Arrangements. London: Department of Health, 2007.

12. PGEU-Secretariat. Why PharmaciesNeed Fully Qualified Pharmacists?Brussels: Pharmaceutical Group of the European Union, 2009.

13. Anell A. Deregulating the pharmacymarket: the case of Iceland and Norway.Health Policy 2005;75:9–17.

Hospital privatisation inPoland

Peggy Watson


situation was exacerbated by the risingcosts of pharmaceuticals. In 2007, the pro-portion of total health care spendingaccounted for by pharmaceuticals wasabout 32%, more than the proportion ofspending accounted for by either ambu-latory or hospital care. The proportionspent on hospital care meanwhile was rel-atively low and roughly the same as theproportion of spending accounted for byambulatory care – about 28%.4

Perhaps unsurprisingly, the reforms werenot popular with the general public.2,5 Anopinion poll carried out in 2001 found that74% of respondents thought that healthcare provision had been better before thereform.6 Data from the biennial PolishDiagnosis Survey suggest this negativeopinion has not improved over time (seeTable 1).

Restructuring the hospital systemStarting with the 1991 Health Care Insti-tutions Act, the Polish hospital systembecame increasingly decentralised duringthe 1990s. The law allowed for the exis-tence of diverse health care unit ownersbeyond the Ministry of Health, includingregional and local government, other min-istries, non-governmental organisationsand private bodies. It provided the legal

basis for publicly owned hospitals inPoland to become substantially autono-mous and responsible for managing theirown budgets. After 1993. ownership ofmost public sector health facilities passedto the regions and to local government(gminas);8 when a three-tier territorialdivision was introduced in 1999, manyhospitals passed from gminas to largeradministrative areas known as powiats.Table 2 shows the number of public hos-pitals in Poland according to ownership in2007.

According to central statistical agencyfigures from 2002, the most recentavailable, among public hospitals, 38.37 %of beds were in hospitals owned by thevoivodeships and 45.71% in hospitalsowned by the powiats.4 Although privati-sation has been legally possible since 1999,for political and economic reasons, thisprocess has been slow. By 2007, there were170 private hospitals representing approx-imately 23% of non-psychiatric hospitalsin Poland. Most were relatively small andin 2007 accounted for only 5.8 % of hos-pital beds.9

Health workers’ protestsIn the two years following the healthreforms (1999–2000), the country was

swept by unrest among health care per-sonnel, including doctors, radiographers,medical technicians and ambulance staff.However, it was the industrial action ofnurses which seized the headlines. Nursesrepresented the largest occupationalgrouping in Poland, one of the lowest paid,and one most consistently opposed to hos-pital privatisation. The All-Polish Unionof Nurses and Midwives (OgólnopolskiZwiązek Zawodowy Pielęgniarek iPołożnych – OZZPiP) became a visiblepolitical actor at this time. The nationalunion grew out of a local union originallyformed in the town of Włocławek in 1991.By 1995, when it gained its nationalstatute, 86,000 nurses, about one out ofevery two employed in hospitals, hadjoined.

Not only had nurses seen no pay improve-ments with the 1999 reform, benefits suchas the inflation-link to their salaries haddisappeared. Unrealistic budgets and theincreasing proportion of budget expen-diture being accounted for by drugs meantextreme downward pressure on staffingcosts. While spending on personnel wasslightly higher than pharmaceutical costsin 1999, by 2003 total spending on drugswas 29% higher than the combined wagebill for all categories of health care personnel.4

The Union’s high profile protest actionincluded hunger strikes, the occupation ofstate buildings and the blockade ofnational borders and roads. The gov-ernment eventually conceded to thenurses’ demands and signed an agreementawarding all health workers a 203 złoty(PLN) salary increase. The resulting ‘Law203’ came into force on 1 January, 2001.However, since no extra funds were madeavailable for this purpose and responsi-bility for payment remained with thedirectors of health care institutions, the lawserved to exacerbate the financial diffi-culties experienced within the system.

Hospital debtDebts, in accordance with the Polish Min-istry of Health definition refer to accruedliabilities due, that is, all liabilities whosepayment date has passed and which havenot been cancelled or become time-barred,where the creditor is entitled to impose asurcharge on the amount due – butexcludes the value of loans, share issues,and similar.4 During the 1990s, many hos-pitals had accumulated such debts andthese were successively cleared in 1994,1996 and 1997. Hospital debts were also



Table 1: Perception of change in extent to which health needs have been met 2000–09.

In the last two years the extent towhich health needs are met has (%):

2000 2003 2005 2007 2009

Deteriorated 41 39 38 27 25

Improved 3 4 3 4 3

No change 56 58 59 69 72

Source: Polish Social Diagnosis 2009.7

Table 2: Public Hospitals in Poland by Type (December 31st 2007)

Local Government 517

Ministry or central government (except Ministry of Defence andMinistry of Internal Affairs)

19

University/Research Institute 42

Total non-psychiatric public hospitals 578

Psychiatric hospitals 52

Source: Polish Ministry of Health Statistical Bulletin 20089

cleared with the introduction of the 1999reforms. At the same time, hospitalrestructuring, at a cost of PLN295 millionto the state budget, resulted in a decreasebetween 1999 and 2002 of more than92,000 health care staff and 35,900 hospitalbeds. Unions expressed concerns that per-sonnel reductions had at times taken placein contravention of official staffingnorms.10

However, contractual rates of payment tohospitals after 1999 were significantly lessthan the cost of services in practice, andthis was largely responsible for the factthat levels of hospital indebtedness roseagain after the reforms.11 Interest rates onearlier debts, as well as court costs, alsocontributed to debts spiraling out ofcontrol. Between 2002 and June 2004, theaccumulation of debts doubled.1

The most recent legislation to relieve hos-pital indebtedness was introduced in 2005(Ustawa z dn. 15 kwietnia o Pomocy Pub-licznej i Restrukturyzacji PublicznychZakładów Opieki Zdrowotnej). After thisintervention, the level of hospital debtdecreased. This was due to the roll-over ofmany outstanding liabilities, the cancel-lation of others, as well as the fact thathospital revenue increased.

Social health insurance contribution rateswent up year on year between 2003 and2007, while at the same time the base towhich the rates applied improved withrising incomes and falling rates of unem-ployment. The combination of thesefactors meant that health sector incomefrom social insurance contributions wentup from PLN31.5 to 42.2 billion between2004 and 2007.4

Nevertheless, the question of hospitalunderfunding was far from resolved. Forexample, a 2008 monitoring survey of psy-chiatric in-patient care found thatcontracts with the NFZ in general coveredbetween 60% and 80% of costs. Forexample, in 2006–2007 the daily rate paidby the NFZ for a person/day in a psychi-atric ward stood at PLN78 and 84,respectively, while in the Lubiąż hospitalthe average cost of a person/day wasPLN125.11 and 145.5. This resulted inlosses of PLN1.55 million in 2005,PLN2.41 million in 2006, and PLN973,700in the first half of 2007.12

After 2005, the structure of hospitalindebtedness significantly changed.Unpaid wages to employees which repre-sented about 16% of debt at the end of2005, were reduced to a residual 3% by the

end of 2007. Between the end of 2005 andthe end of 2007, the percentage of debtaccounted for by unpaid local taxes, landtaxes, and social insurance contributionson behalf of employees fell from just over43% to about 28% of all debt, largelybecause much of this debt was cleared. Onthe other hand, the proportion of all debtaccounted for by amounts owed to thesuppliers of pharmaceuticals and medicalsupplies/equipment rose from 20% to30%.4

The politics of privatisationHealth care has become a highly politicisedissue in Poland, and health care issuesplayed a prominent role in the electionwhich took place at the end of 2007. Theyear had seen strikes and other high profileindustrial action by health workers, culmi-nating in mass protests, most visibly by theOZZPiP nurses’ union. The hub of the‘white protest’ as it came to be known, wasan encampment (the białe miasteczko or‘white village’) along the grass vergesopposite the Prime Minister’s Chancellery,where a request for pay negotiations hadbeen handed in.

The białe miasteczko dominated theWarsaw horizon for a short but significanttime. During the twenty-seven days of itsexistence (from 19 June to 15 July) hun-dreds of nurses arrived from all overPoland to take part in the protests. Theprotests received overwhelming publicsupport. In a poll carried out by the publicopinion research centre CBOS in 2007,88% of respondents were in support of thenurses, including their hunger strikes. Theencampment was visited by Warsaw resi-dents, politicians, as well as figures fromacademia and the arts who also voiced theirsupport. The protest ended without nego-tiations when Parliament dissolved.

During the election campaign, the CentralAnti-Corruption Agency (CentralneBiuro Anti-Korupcyjne – CBA) releasedtapes of a conversation it had secretlyrecorded earlier in the year, between aCivic Platform parliamentarian, BeataSawicka, and a CBA official posing as abusinessman. The tapes, apparently indi-cating corruption at the heart of hospitalprivatisation, caused a furore. Prime Min-ister Jarosław Kaczyński described theaffair as ‘a gigantic plan to rob Poland, andto rob Polish patients’, the former Pres-ident Aleksander Kwaśniewski criticisedthe use of the CBA during the electioncampaign, and Sawicka was expelled fromher Party on the spot. Nevertheless, the

tapes did not prevent the Civic Platformfrom coming to power.

Among its early actions were high profileconsultations – the ‘White Summit’ (białyszczyt), with stakeholders in health carechange. The health care workers’ unions,professional bodies and other social organ-isations were all present at meetings heldbetween January and March 2008. Anumber of points were eventually agreed.These included the right to buy treatmentto avoid queues, the introduction ofmodest fees for clinic visits and hospitalmeals, and the right to buy private healthinsurance in addition to, or instead of,social insurance. The introduction of abasket of guaranteed services was deferred,while agreement to hospital privatisationthat was optional and partial was secured.

Several weeks later proposed legislationwas revealed which departed radicallyfrom the White Summit agreement. Thenew law was to make it compulsory for allhospitals – most of which were still inde-pendently functioning units under localauthority management – to become busi-nesses, thus opening the way for their sale.A simultaneous newspaper poll indicatedthat over half of respondents were againstprivatisation, as compared with about onethird in favour (Rzeczpospolita, 8 May2008).

It is unclear what took place between theMarch and May policy announcements,however, a former Health Minister,Mariusz Łapiński, gave his view in a recentinterview stating that ‘there are firms inPoland which are ready to take overindebted hospitals, firms which boughthospital debts earlier on. The lobby actingon behalf of these firms has been forcingthrough changes in the law which to allowthis kind of operation’.3

The new proposals were eventually put toParliament in the form of a members’ bill.This meant that the statutory requirementfor consultation with social organisationsin the field of health care did not apply.Most of these organisations were againstthe compulsory commercialisation – andhence privatisation – of hospitals, and hadindicated this at a meeting with the Pres-ident.13 A presidential bid to hold areferendum on hospital privatisation wasoverruled. This idea had had widespreadsupport – a survey commissioned byRzeczpospolita had found 71% of respon-dents to be in favour of one.14

In October 2008, the bill was accepted bythe Polish Senate. The health workers’



unions continued to argue that commer-cialisation meant an open door toprivatisation, saying that it would bring adeterioration of living conditions both forworkers and for patients, leading to furthersocial divisions and worse access to healthcare for the poor.15 Approximately onemonth later, President Lech Kaczyński ofthe opposing PiS Party used his powers toveto the bill. The consequence was theintroduction by the government of whathas come to be known as ‘Plan B’ for hos-pital privatisation, which took anextra-legislative route.

The economic crisisHealth policy in Poland entered a newphase with the financial crisis of 2008.Increasing unemployment and fallinglevels of pay has meant that in 2009, NFZrevenue fell below the level assumed in itsbudget for the first time in five years.16 Atthe same time, a fall in the value of the cur-rency has translated into higher costs tothe NFZ for the health care of Polishpatients elsewhere in Europe.

Hospitals will receive less from the NFZthan in 2008, since there are no excessfunds from which payment can be madefor patients treated over and above thelimit defined in contracts – and in somecases the limits for 2009 have already beenreached.17 Banks are even less willing tolend to hospitals than before the crisis,opening the way for debt purchasing firmsto extend their services to the provision ofloans, often at high rates of interest (figuresof 15%–20% have been quoted in thepress).

Plan B for hospital privatisation was intro-duced in April 2009, and is scheduled torun until 2011. It offers to cover from gov-ernment funds part of the outstandingdebts of hospitals where local authoritieshave agreed to privatise hospitals and haveput forward an acceptable business plan.However, the sum earmarked for thepurpose has changed from an initial sum ofPLN2.7 billion (the total debt of Polishhealth care institutions), to PLN1.38billion. As of writing no agreement hasbeen signed between a local authority andthe Ministry of Health within theframework of this programme, and wherelocal authority preparations are underway,they have provoked health workers’protests.18

Although the government has not with-drawn Plan B, some hold the view that itwould now suit the government to deferthe implementation of the programme

until 2011, when the state budget may bein better health.19 What will happenbetween now and then is, however,uncertain to say the least.

REFERENCES

1. Kuszewski K, Gericke C. Poland.Health Systems in Transition. Copenhagen:World Health Organization RegionalOffice for Europe, 2005.

2. Watson P. Unequalizing citizenship: Thepolitics of health care change in Poland.Sociology 2006;40(6):1079–96.

3. Piński J. Skok na Szpitale: Rozmowa zMariuszem Lapińskim, Byłym MinistremZdrowia [Hospital raid: interview withMariusz Lapinski, former Minister ofHealth]. Wprost 30 November 2008:38–39.

4. Ministerstwo Zdrowia. Raport:Finansowanie Ochrony Zdrowia w Polsce –Zielona Ksiega II [Report: FinancingHealth Care in Poland – The Green BookII]. Warszawa: Ministerstwo Zdrowia,2008.

5. Watson P. Stress and social change inPoland. Health and Place 2006;12:372–82.

6. CBOS. Opinie o Opiece Zdrowotnej PodKoniec Drugiego Roku Reformy [OpinionsRegarding Health Care at the end of theSecond Year of the Reform]. Warszawa:CBOS, 2001.

7. Polish Social Diagnosis 2009, Table 4.7.4,p.114. Available at:http://www.diagnoza.com/pliki/raporty/Diagnoza_raport_2009.pdf

8. Karski J, Koronkiewicz A, Healy J.Health care systems in transition – Poland.Copenhagen: World Health OrganizationRegional Office for Europe, 1999.

9. Polish Ministry of Health Statistical Bulletin 2008, Table 4.3, p.45. Available at:http://www.csioz.gov.pl/pliki/file.php?s=cD80

10. Banachowicz B. Chair of OZZPiP,Statement to the Tripartite Commission forSocial and Economic Affairs, 2004.

11. Chmielewski D. Sekurytyzacja –Lekarstwo na Szpitalne Długi? [Securiti-sation: medicine for hospital debt?]. SłużbaZdrowiaMarch 7–18 2002:19–22.

12. Najwyższa Izba Kontroli InformacjaoWynikach Kontroli FunkcjonowaniaOpieki Psychiatrycznej, Ze SzczególnymUwzględnieniem Opieki Stacjonarnej

[Findings from the Monitoring of Psychiatric Care, with an Emphasis on In-patient Care]. Wrocław: NIK, Delegatura We Wrocławiu, 2008.

13. Cichocka E. Bez Referendum wSprawie Prywatyzacji Szpitali [Without areferendum on hospital privatisation]Gazeta Wyborcza 29 October 2008.

14. Dziennik Polski. O PrywatyzacjęSzpitali Zapytajmy Lud [Let’s ask thepeople about hospital privatisation]. Dziennik Polski 10 October 2008.Available at: http://www.dziennik.pl/wydarzenia/article249642/O_prywatyzacje_szpitali_zapytajmy_lud.html

15. Polskie Radio. Związkowscy Apelujądo Prezydenta o Zawetowanie UstawZdrowotnych [Unions call on President toveto health laws]. Polskie Radio 24November 2008. Available at:http://www.polskieradio.pl/iar/wiadomosci/artykul76723.html

16. Szparkowska S. Kryzys Dotarł do NFZ[The crisis has reached the NFZ]. Rzeczpospolita 4 September 2009. Availableat: http://www.rp.pl/artykul/288705.html?

17. Sroka, J. Doctors protest againstreduced financing of hospital services,European Industrial Relations ObservatoryOnline 13 February 2009. Available at:http://www.eurofound.europa.eu/eiro/2009/01/articles/pl0901049i.htm

18. Kasperska M. Szpitalni ZwiązkowscyProtestują, Nie Strajkują. [Hospital unionsare protesting, not striking] GazetaWyborcza 14 September 2009. Available at:http://miasta.gazeta.pl/wroclaw/1,79448,7037993,Szpitalni_zwiazkowcy_protestuja__nie_strajkuja.html

19. Sikora D. Przekształcenie Szpitali w Spółki WciążNiepewne [The transformation of hospitals into firms stilluncertain]. Gazeta Prawna 15 September2009. Available at http://praca.gazetaprawna.pl/artykuly/351902,przeksztalcenia_szpitali_w_spolki_wciaz_niepewne.html



Acknowledgement: This article draws on work funded by the British Academy.

http://www.diagnoza.com/pliki/raporty/Diagnoza_raport_2009.pdf

http://www.csioz.gov.pl/file.php?s=cD80

http://www.dziennik.pl/wydarzenia/article249642/O_prywatyzacje_szpitali_zapytajmy_lud.html

http://www.polskieradio.pl/iar/wiadomosci/artykul76723.html

http://www.rp.pl/artykul/288705.html?

http://www.eurofound.europa.eu/eiro/2009/01/articles/pl0901049i.htm

http://miasta.gazeta.pl/wroclaw/1,79448,7037993,Szpitalni_zwiazkowcy_protestuja__nie_strajkuja.html

http://praca.gazetaprawna.pl/artykuly/351902,przeksztalcenia_szpitali_w_spolki_wciaz_niepewne.html

BackgroundA wide variety of OTC analgesics are available tobuy, but the amount of high quality informationabout these treatments is limited. We set out tofind evidence for the efficacy of a range of OTCanalgesics, available in various parts of the world,in standard acute pain trials. Specifically we werelooking for single dose data from four to six hourtrials in post-operative pain models, and reportingstandard outcomes.

Clinical trials measuring the efficacy of analgesicsin acute pain have been standardised over manyyears. Trials have to be randomised and doubleblind. Typically, in the first few hours or days afteran operation, patients develop pain that is mod-erate to severe in intensity, and will then be giventhe test analgesic or placebo. Pain is measuredusing standard pain intensity scales immediatelybefore the intervention, and then using painintensity and pain relief scales over the followingfour to six hours for shorter acting drugs. Painrelief of half the maximum possible pain relief orbetter (at least 50% pain relief) is typicallyregarded as a clinically useful outcome. Forpatients given rescue medication it is usual for noadditional pain measurements to be made, and forall subsequent measures to be recorded as initialpain intensity or baseline (zero) pain relief(baseline observation carried forward). Thisprocess ensures that analgesia from the rescuemedication is not wrongly ascribed to the testintervention. In some trials the last observation iscarried forward, which gives an inflated responsefor the test intervention compared to placebo, butthe effect has been shown to be negligible overfour to six hours.

Single dose trials in acute pain are commonlyshort in duration, rarely lasting longer than twelvehours, allowing no reliable conclusions to bedrawn about safety. To show that the analgesic isworking it is necessary to use placebo. There are

clear ethical considerations in doing this. Theseethical considerations are answered by using acutepain situations where the pain is expected to goaway, and by providing additional analgesia, com-monly called rescue analgesia, if the pain has notdiminished after about an hour. This is reasonable,because not all participants given an analgesic willhave significant pain relief. Approximately 18%of participants given placebo will have significantpain relief, and up to 50% may have inadequateanalgesia with active medicines.

Systematic review and methodsFor references to methods used, refer to Moore Aet al, 2003.1

We searched PubMed, Cochrane Central Library,and our own in-house databases in pain researchfor any double-blind, randomised controlled trials(RCTs) reporting pain relief, pain intensity, orpatient global evaluation of efficacy as outcomesover 4–6 hours for single dose analgesic versusplacebo. The search terms used included bothtrade names and generic names of the individualanalgesic constituents, including combinationswhere appropriate. It is not likely that all OTCanalgesics have been included, since sources forOTC analgesic names and availability are not easyto come by, and may change from time to time.OTC analgesic combinations, in particular, maychange. The approach, therefore, was to workwith combinations of drugs and doses of the com-binations that appeared to be current in 2009.

From these trials we extracted outcome data,including pain relief measured as a TOTPAR(total pain relief) at four or six hours, and painintensity measured as a SPID (summed painintensity difference) at four or six hours. MeanTOTPAR or SPID values, for both the activeanalgesic and placebo, were then converted to%maxTOTPAR or %maxSPID by division intothe calculated maximum value. The proportion ofparticipants in each treatment group who achievedat least 50%maxTOTPAR was calculated usingverified equations, and these proportions con-verted into the number of participants achieving


Investigating over-the-counter oral analgesics

There is good evidence supporting the efficacy of standard doses of aspirin, paracetamol, ibuprofen, naproxen, and diclofenac, all of which are available asover-the-counter (OTC) medicines in some part of the world. There is no good evidence for most branded combination products, though it is likely that additional analgesic effect is produced by codeine.

Evidence-based health care

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

This paper was first published in 2009. © Bandolier, 2009.

http://www.medicine.ox.ac.uk/bandolier

at least 50%maxTOTPAR by multiplyingby the total number of participants in thetreatment group. Information on thenumber of participants with at least50%maxTOTPAR for active treatmentand placebo was then used to calculate rel-ative benefit (RB) and number-needed-to-treat-to-benefit (NNT).

ResultsOne hundred and twenty five RCTs wereretrieved that matched the search criteria.After closer scrutiny, six head-to-headcomparative trials were excluded due tolack of a placebo control, and two trialswere excluded due to lack of analysabledata. The remaining 117 trials were ran-domised, double blind and placebocontrolled and were included in theefficacy analysis. The studies involved amixture of dental pain and episiotomypain.

The overall standard and quantity of dataavailable was poor, particularly for studiesspecifically using the trade name OTCanalgesics. To compensate for this we haveincluded data on the equivalent dosegeneric named analgesics and their combi-nations. For some of the test analgesics(Anadin Extra, Askit, Codis, Dispirin,Dispirin Extra, Panadeine 15, Paracodol,Paramol, Pentalgin H, Sedalgin-neo, Sol-padeine Max) no useable data could befound. In many cases, particularly thosecombination analgesics including codeine,this was due to differences in the doses ofthe constituent analgesics used in theavailable trials as compared with the OTCversions. In general, OTC containingcodeine tended to use significantly lowerdoses of codeine and higher doses of otherconstituents; presumably to minimisecodeine-related side effects. Informationon combinations of paracetamol andibuprofen is included since these newercombinations are likely to appear as OTCanalgesics in several parts of the world.

Table 1 gives information about theincluded studies. Table 2 summarises dataavailable for each of the analgesics alongwith its calculated relative benefit andnumber-needed-to-treat-to-benefit. Table3 shows a sub-analysis of only those trialsinvolving dental pain.

To summarise the findings of our investi-gation we produced comparative figures(Figures 1 and 2 for all data and just dentalstudies, respectively) showing the NNTsand their 95% confidence intervals foreach analgesic where calculable.

CommentThere are two main issues when looking atthe evidence of acute pain efficacy of OTCanalgesics. The first is the dearth of evi-dence in the public domain for some ofthese products. The second is what we areable to make of what evidence we have.

Dearth of evidenceMost of the OTC analgesics, includingcombination analgesics, were developeddecades ago, as long ago as the 1950s, intimes when trials were performed for reg-istration purposes. Publication wasinfrequent. A good example is a review of30 trials involving about 10,000 patientsexamining the analgesic efficacy of caffeinein combination with analgesics publishedin JAMA in 1984.2 Most of the data wasunpublished then, and has remainedunpublished subsequently. We know moreabout OTC drugs like paracetamol and

ibuprofen from trials in which they havebeen used as active comparators than trialsin which they themselves have beentested.3

The dearth of evidence is not, therefore,surprising. It is, however, frustrating. Forseveral OTC analgesics we have no reliabledata, and for others the data available areinadequate – leading to very wide confi-dence intervals in Figures 1 and 2. This is ashame, because OTC analgesics, properlyused, are effective for many people.

It is also the case that the case for analgesiccombinations can be developed using evi-dence from closely related studies. A casein point is the combination of paracetamoland codeine, where relatively smallamounts of information for some dosecombinations are bolstered with evidencefrom other dose combinations.4


EVIDENCE-INFORMED DECISION MAKING

0 2 4 6 8 10 12 14 16 18

Aspirine (141)

Aspro Clear (345)

Feminax Ultra (402)

Nurofen (5428)

Panadol (2171)

Panadol Extra (81)

Saridon (301)

Solpadeine Plus (61)

Voltarol (398)

NNT for at least 50% pain relief (4–6 hours)

0 2 4 6 8 10 12 14 16 18

Aspirine (371)

Aspro Clear (679)

Cuprofen Plus (167)

Feminax Ultra (784)

Nurofen (6475)

Panadol (3232)

Panadol Extra (81)

Saridon (301)

Solpadeine Plus (61)

Voltarol (502)

NNT for at least 50% pain relief (4–6 hours)

Figure 1: NNTs (number-needed-to-treat-to-benefit) for all available data

Figure 2: NNTs (number-needed-to-treat-to-benefit) for dental studies only



Table 1: Details of available data

Drug Details of available data References of included studies

Anadin Extra We found no trials comparing Anadin Extra (or a generic combination analgesic containing paracetamol, aspirin and caffeine in similar doses) to placebo

N/A

Askit We found no trials comparing Askit (or a generic combination analgesic containing aspirin, caffeine and aloxiprin in similar doses) to placebo

N/A

Aspirine We found two trials comparing a generic combination of aspirin and caffeine (ASA 650mg/caffeine 65mg in Forbes et al. and ASA 800mg/caffeine 65mg in Rubin et al.) against placebo.Both trials were relatively small and used different pain types: Forbes et al. (n=141) in dental andRubin et al. (n=230) in episiotomy. The results reflect this with Forbes et al. reporting the % of patients achieving 50% pain relief on the active treatment as 27% and on the placebo as 1%; while Rubin et al. report 86% on the active treatment and 48% on the placebo

Forbes JA. Pharmacotherapy1990;10(6):387–93

Rubin A. J Int Med Res.1984;12(6):338–45

Aspro Clear We found seven trials in a Cochrane review of single dose oral aspirin for acute pain (currently undergoing in-house update) comparing aspirin in any formulation (ASA 1000mg) against placebo

Edwards JE. Cochrane DatabaseSyst Rev. 2000;(2):CD002067

Codis We found no trials comparing Codis (or a generic combination analgesic containing aspirin andcodeine in similar doses) to placebo

N/A

Cuprofen Plus We found two trials comparing a generic combination of ibuprofen and caffeine (IBU 400mg/COD 30mg) against placebo. Both trials reported pain following episiotomy with similar results

Cater M. Clin Ther.1985;7(4):442–47

Norman SL. Clin Ther. 1985;7(5):549–54

Disprin We found no trials comparing Dispirin (or a generic formulation of aspirin in a similar dose) toplacebo

N/A

Disprin Extra We found no trials comparing Dispirin Extra (or a generic combination of aspirin and paracetamolin similar doses) to placebo

N/A

Feminax Ultra We found five trials in an up-to-date Cochrane review of single dose oral naproxen for acute pain comparing naproxen or naproxen sodium (NAPROX 500mg or NAPROX SODIUM 550mg)against placebo

Derry C. Cochrane Database SystRev. 2009 Jan 21;(1);CD004234

Mersyndol We found one trial comparing Mersyndol against placebo. The trial reported pain following dental surgery

Margarone JE. Clin PharmacolTher. 1995;58(4):453–58

Nurofen We found 61 trials in an up-to-date Cochrane review of single dose oral ibuprofen for acute pain comparing a generic formulation of ibuprofen (IBU 400mg) against placebo

Derry C. Cochrane Database SystRev. 2009 Jul 8;(3):CD001548

Panadeine 15 We found no trials comparing Panadeine 15 (or a generic combination of paracetamol and codeine in similar doses) to placebo

N/A

Panadol We found 28 trials in an up-to-date Cochrane review of single dose oral paracetamol for acute pain comparing a generic formulation of paracetamol (PARA 1000mg) against placebo

Toms L. Cochrane Database SystRev. 2008 Oct 8;(4):CD004602

Panadol Extra We found one trial comparing a generic combination of paracetamol and caffeine (PARA 1000mg/CAF 130mg) against placebo. The trial reported pain following dental surgery

Winter L Jr. Current TherapeuticResearch 1983;33(1):115–22

Paracodol We found no trials comparing Paracodol (or a generic combination of paracetamol and codeine in similar doses) to placebo

N/A

Paramol We found no trials comparing Paramol (or a generic combination of paracetamol and dihydrocodeine tartrate in similar doses) to placebo

N/A

Pentalgin H We found no trials comparing Pentalgin H (or a generic combination of naproxen, codeine, caffeine, dipyrone and phenobarbitol in similar doses) to placebo

N/A

Saridon We found one trial comparing Saridon against placebo. The trial reported pain following dental surgery

Kiersch TA. Curr Med Res Opin.2002;18(1):18–25

Sedalgin-neo We found no trials comparing Sedalgin-neo (or a generic combination of paracetamol, caffeine,codeine, dipyrone and phenobarbitol in similar doses) to placebo

N/A

Solpadeine Max We found no trials comparing Solpadeine Max (or a generic combination of paracetamol andcodeine in similar doses) to placebo

N/A

Solpadeine Plus We found one trial comparing a generic combination of paracetamol, codeine and caffeine (PARA1000mg/COD 16mg/CAF 30mg) against placebo. The trial reported pain following dental surgery

Cooper SA. Anesth Prog.1986;33(3):139–42

Voltarol We found four trials in an up-to-date Cochrane review of single dose oral diclofenac for acute pain comparing all generic formulations of diclofenac (DICLO 25mg) against placebo

Derry P. Cochrane Database SystRev. 2009 Apr 15;(2):CD004768



Table 2: Summary of data available for each analgesic showing calculated relative benefits (RB) and number-needed-to-treat-to-benefits (NNT)

Drug Constituents Number of trials Number ofpatients

Percentagewith active

Percentagewith control

RB (95% CI)

NNT (95% CI)

Anadin Extra Para400 + Asa600 + Caf90 0

Askit Asa530 + Caf110 + Aloxiprin140 0

Aspirine Asa650 + Caf65

2 371 65 28 2.3 (1.8–3.0) 2.7 (2.2–3.7)

Forbes 1990 141 17 0 39.8 (2.4–648) 3.9 (2.7–6.7)

Rubin 1984 230 86 48 1.8 (1.5–2.2) 2.6 (2.0–3.7)

Aspro Clear Asa1000 7 679 43 16 2.6 (2.0–3.5) 3.7 (3.0–5.0)

Codis Asa1000 + Cod base 16 0

Cuprofen Plus Ibu400 + Cod base 20 2 167 55 31 1.8 (1.2–2.6) 4.1 (2.6–10.3)

Disprin Asa900 0

Disprin Extra Asa600 + Para4000

Margarone 1995 76 21 8 2.7 (0.8–9.3) 7.6

Feminax Ultra Naprox5009 784 52 15 3.4 (2.7–4.4) 2.7 (2.3–3.2)

Winter 1983 81 48 22 2.2 (1.1–4.2) 3.9 (2.2–18.0)

MersyndolPara1000 + Cod base15 + Doxylamine succinate10

1 76 21 8 2.7 (0.8–9.3) Not calculated

Nurofen Ibu400 61 6475 54 14 4.0 (3.6–4.4) 2.5 (2.4–2.6)

Panadeine 15 Para1000 + Cod base23 0

Panadol Para100028 3232 46 18 2.5 (2.2–2.9) 3.6 (3.2–4.0)

Cooper 1986 61 29 4 6.2 (0.9–45.0) 4.2 (2.5–14.2)

Panadol Extra Para1000 + Caf130 1 81 48 22 2.2 (1.1–4.2) 3.9 (2.2–18.0)

Paracodol Para1000 + Cod base13 0

ParamolPara1000 + Dihydrocodeine tartarate15

0

Pentalgin HNaprox100 + Cod base8 + Caf50 +Dipyrone300 + Phenobarbitol15

0

SaridonPara500 + Caf100 + Propifenazone300

1 301 23 2 9.2 (1.3–64.5) 4.9 (3.6–7.4)

Sedalgin-neoPara600 + Caf100 + Cod base20 +Dipyrone300 + Phenobarbitol30

0

Norman 1985 74 53 29 1.8 (1.0–3.3) 4.2 (2.2–48.5)

Cater 1985 93 57 32 1.8 (1.1–2.9) 4.1 (2.3–19.8)

Solpadeine Max Para1000 + Cod base20 0

Solpadeine Plus Para1000 + Caf60 + Cod base13 1 61 29 4 6.2 (0.9–45.0) 4.2 (2.5–14.2)

Voltarol Diclo25 4 502 53 15 3.6 (2.6–5.0) 2.6 (2.2–3.3)

Para = paracetamol, Asa = aspirin, Caf = caffeine, Cod = codeine, Naprox = naproxen, Diclo = diclofenac, Ibu = ibuprofen.



What can we make of the evidence wehaveThe best evidence we have is fromibuprofen 400mg (Nurofen), paracetamol10,000mg (Panadol), naproxen 500mg(Feminax Ultra), diclofenac 25mg(Voltarol), and aspirin 1,000mg (Aspro),though the evidence is likely not to havecome from testing of any particularproduct. All of these analgesics have use-fully low NNTs in the range of about 2–4.

The evidence for combination analgesics isless clear, with predominantly no trials, ortoo few trials and patients available tomake any judgement. This is a shame,

because there is evidence elsewhere (Smithet al, 20014, for example) that combina-tions of analgesics can produce very goodresults.

Consumers can make up their own mindswhether the expense of branded analgesicsis worth it compared to the often muchlower cost of unbranded – though that is aUK view, and certainly analgesics likeparacetamol and ibuprofen are available inquantity and at low cost in the USA.

REFERENCES

1. Moore A, Edwards J, Barden J, McQuay

H. Bandolier’s Little Book of Pain. Oxford:Oxford University Press, 2003.

2. Laska EM, Sunshine A, Mueller F, ElversWB, Siegel C, Rubin A. Caffeine as ananalgesic adjuvant. Journal of the AmericanMedical Association 1984;251(13):1711–18.

3. Barden J, Derry S, McQuay HJ, MooreRA. Bias from industry trial funding? Aframework, a suggested approach, and anegative result. Pain 2006;121(3):207–18.

4. Smith LA, Moore RA, McQuay HJ,Gavaghan D. Using evidence from differ-ent sources: an example using paracetamol1000 mg plus codeine 60 mg. BMC MedicalResearch Methodology 2001;1:1.

Table 3: Sub-analysis of only those trials involving dental pain

Drug ConstituentsNumber of

trials Number ofpatients

Percentagewith active

Percentagewith control

RB (95% CI) NNT (95% CI)

Anadin Extra Para400 + Asa600 + Caf90 0

Askit Asa530 + Caf110 + Aloxiprin140 0

Aspirine Asa650 + Caf65 1 141 17 0 39.8 (2.4–648) 3.9 (2.7–6.7)

Aspro Clear Asa1000 3 345 32 11 2.9 (1.8–4.8) 4.7 (3.4–7.6)

Codis Asa1000 + Cod base 16 0

Cuprofen Plus Ibu400 + Cod base 20 0

Disprin Asa900 0

Disprin Extra Asa600 + Para400 0

Feminax Ultra Naprox500 5 402 62 7 8.9 (5.3–14.9) 1.8 (1.6–2.1)

MersyndolPara1000 + Cod base15 + Doxylamine succinate10

1 76 21 8 2.7 (0.8–9.3) Not Calculated

Nurofen Ibu400 49 5428 55 12 4.7 (4.2–5.2) 2.3 (2.2–2.4)

Panadeine 15 Para1000 + Cod base23 0

Panadol Para1000 18 2171 40 9 4.4 (3.5–5.5) 3.3 (3.0–3.7)

Panadol Extra Para1000 + Caf130 1 81 48 22 2.2 (1.1–4.2) 3.9 (2.2–18.0)

Paracodol Para1000 + Cod base13 0

ParamolPara1000 + Dihydrocodeine tartarate15

0

Pentalgin HNaprox100 + Cod base8 + Caf50 +Dipyrone300 + Phenobarbitol15

0

SaridonPara500 + Caf100 + Propife-nazone300

1 301 23 2 9.2 (1.3–64.5) 4.9 (3.6–7.4)

Sedalgin-neoPara600 + Caf100 + Cod base20 +Dipyrone300 + Phenobarbitol30

0

Solpadeine Max Para1000 + Cod base20 0

Solpadeine Plus Para1000 + Caf60 + Cod base13 1 61 29 4 6.2 (0.9–45.0) 4.2 (2.5–14.2)

Voltarol Diclo25 3 398 51 11 4.6 (3.1–7.1) 2.5 (2.1–3.2)

Para = paracetamol, Asa = aspirin, Caf = caffeine, Cod = codeine, Naprox = naproxen, Diclo = diclofenac, Ibu = ibuprofen.

Whole-body screening is promoted as a one-stop shop for painlessly detecting hiddencancer and preventing cancer-related deaths. Itis big business in the United States.1 InCanada, private clinics have begun offeringfull-body diagnostic procedures for a fee.2,3

The tests and procedures are often marketedto healthy people as a way to scan for hiddenabnormalities or cancers, affording people thepeace of mind that they are in good health.2,3

When used in this manner, the evidence showsthat whole-body cancer screening offers noproven health benefits and that it, in fact,exposes people to a number of unnecessaryhealth risks.

Sound screening is sensitive and specificUsing Computerised Tomography (CT), Mag-netic Resonance Imaging (MRI) technologyor, at times, Positron Emission Tomography(PET), whole-body screening involvesscanning the body from different depths andangles to compile an image that can beexamined for abnormalities. When these testsare used to make, confirm or refine a diagnosisin patients with cancer symptoms, or tomonitor patients undergoing cancer treat-ments, the benefits outweigh the risks.4

Screening to detect abnormalities or possiblecancers can lead to one of four outcomes:

– normal test result and no cancer (true negative)

– normal test result, but an undetected cancer(false negative)

– abnormal test result, but no cancer (falsepositive)

– abnormal test result and actual cancer (truepositive).5

False positives in particular often lead to acascade of additional testing and biopsies,which can bring additional costs to the healthcare system as well as further risks to thepatient, not the least of which are anxiety,

worry and medical complications.6 A goodscreening test is sensitive and specific, pro-ducing a low rate of false negatives and falsepositives. It should also reduce the number ofdeaths from the disease tested for, while notsubjecting people to unacceptable harm.7

Generally, recommended cancer screeningtests – for example, a mammogram – meetthese criteria. A mammography for women 50to 69 years of age may decrease breast cancerdeaths by up to 30%,8 while a fecal occultblood test for individuals 50 to 74 years of agecan decrease colon cancer deaths by 15%.9 Aswell, since the introduction of Pap tests morethan 25 years ago, cervical cancer mortalityhas declined by 60%.10

In contrast, there is no evidence that whole-body screening of healthy people preventscancer-related deaths. In fact, evidence showsthat whole-body screening – which is neithersensitive nor specific – poses a number ofserious risks to patients, including unnec-essary examinations, overexposure toradiation, and high false positive and false neg-ative rates.11–13 Whole-body screening alsoincreases the rate of over-diagnosis – the diag-nosis of diseases or ailments that would nothave caused any problems in a person’slifetime or for which therapy is not known tobe effective.14

Risky businessNo screening test is free of risks, but somescreening procedures are more harmful thanothers. It is estimated that whole-body CTscreening, for example, uses 500 to 1,000 timesthe radiation levels of a routine chest x-ray.12

Radiologists have expressed concerns aboutexposing patients to this level of radiation,given the unproven benefits of whole-bodyscreening and the potentially life-threateningrisk in causing radiation-induced cancer.15

Concerns about exposing patients to unnec-essary radiation have been raised related toPET scanning, too.5 Although MRI scanningdoesn’t use ionising radiation, it poses its ownrisks: its magnetic field can pull on or heat upmetallic implants such as pacemakers or pins,causing soft-tissue tears or burning.12

Given the potential risks, assessments of theeffectiveness of whole-body screening should

Mythbusters


Myth: Whole-body screening is an effective way to detect hidden cancers

Mythbusters are prepared by Knowledge Transfer and Exchange staff at the Canadian Health Services Research Foundation and published only after review bya researcher expert on the topic.

The full series is available at www.chsrf.ca/mythbusters/index_e.php. This paper was first published in 2009. © CHSRF, 2009.

This issue of Mythbusters is basedon an article written by KathleenDecker, recipient of the 2009Mythbusters Award. Kathleen is aPhD candidate at the Universityof Manitoba and a research coor-dinator for the Manitoba BreastScreening Program at CancerCareManitoba in Winnipeg.

http://www.chsrf.ca/mythbusters/index_e.php


A series of essays by the Canadian Health ServicesResearch Foundation on the evidence behindhealthcare debates

be based on robust evidence. However,there are no randomised controlled trialsof whole-body screening and only ahandful of retrospective reviews.16–17

These report that the percentage ofpeople who had an abnormal test resultfrom a full-body scan ranged from 33%to 52%.16–17 This is compared to anabnormal rate of 6% for a mammogram18

and 2% for a fecal occult blood test.19

The evidence suggests that whole-bodyscreening is neither sensitive nor specific,and that it can lead to a high rate of falsepositives and negatives. A study thatexamined the abnormalities arising fromwhole-body screening, for example,found that the overwhelming majority –up to 97% – were benign and not clini-cally significant.15 A 2006 study alsoshowed that whole-body PET screeningalone failed to spot 29% of cancersdetected in a population of over 3,400healthy individuals who were subjectedto multiple screening procedures; in otherwords, it also had a significant rate offalse negatives, indicating that those whohave received a whole-body scan shouldnot forego recommended screeningtests.19 The same study found that moreconventional screening tests, likeendoscopy, were successful in leading tocorrect cancer diagnoses.19 A number offalse positives were also reported in asmall, pilot, randomised controlled trialon whole-body screening of healthy sub-jects conducted in the US: 64% of theexperimental (screened) group partici-pants had an abnormal test result, butthere were no confirmed cases of cancer.20

In addition, the medical costs were morethan twice as high for participants in theexperimental group than for those in thecontrol (non-screened) group.

The cost-effectiveness of whole-bodyscreening has been further called intoquestion by a 2006 analysis of thepotential effect of whole-body screeningon health and health care costs, whichestimated that providing full-bodyscreening to a group of 500,000 healthypeople at age 50, at a cost of $2,513 perperson, would lead to an average gain inlife expectancy of only six days in 26.3years.21 False-positive results accounted

for more than 30% of the total costs.21

ConclusionWhole-body screening for healthy peopleoffers the promise of early cancerdetection and reduced cancer-relateddeaths. Despite the claims, such screeninghas not demonstrated any positive effectson life expectancy. Instead, it is tied tosignificant risks, costs and anxiety forclients, as well as to substantial costs andunnecessary service use on the healthcaresystem. Cancer screening recommenda-tions and decisions should be based onreliable data and careful weighing of all ofthe potential benefits and harms.

REFERENCES

1. Scandirectory.com. Updated 12 July2007; Accessed 8 July 2009.

2. EcuMedical. What you need to knowabout full body scans.

3. Canada Diagnostic Centres. How canpreventative health scans help me?http://www.canadadiagnostics.ca/private/preventative-health-scans.php

4. Schmidt GP et al. Whole-body magneticresonance imaging and positron emissiontomography-computed tomography in oncology. Magnetic Resonance Imaging2007;18(3):193–202.

5. Schoder H, Gonen M. Screening for cancer with PET and PET/CT: Potentialand limitations. Journal of Nuclear Medicine 2007;48(1):4–18s.

6. Rosenfeld EL, Duggan AE. Colorectalcancer screening; ensuring benefits outweigh the risks. Medical Journal of Australia 2008; 188(4):196–97.

7. Wilson JM, Jungner YG. Principles andpractice of mass screening for disease.Boletín de la Oficina Sanitaria Panamericana 1968; 65:281–393.

8. Gotzsche PC, Nielsen M. Screening forbreast cancer with mammography.Cochrane Database of Systematic Reviews2006;4:1–61.

9. Hewitson P et al. Screening for colorectal cancer using the faecal occultblood test, Hemoccult. Cochrane Databaseof Systematic Reviews 2007;1(Art. No.:CD001216):1–25.

10. Canadian Cancer Statistics 2006.Toronto: Canadian Cancer Society, 2007.

11 Cassels A, van Wiltenburg J, ArmstrongW. What’s in a scan? How well are con-sumers informed about the benefits andharms related to screening technology (CTand PET scans) in Canada?Ottawa: Cana-dian Centre for Policy Alternatives, 2009.

12. Health Canada, Public Health Agencyof Canada. Whole-body screening usingMRI or CT Technology. It’s Your Health.Ottawa: Health Canada, 2003. Available athttp://tinyurl.com/y9h9cz3

13. Salman RAS, Whiteley WN, Warlow C.Screening using whole-body magnetic resonance imaging scanning: who wants an incidentaloma? Journal of MedicalScreening 2007;14(1):2–4.

14. Modic MT, Obuchowski N. Whole-body CT screening for cancer andcoronary disease: does it pass the test?Cleveland Clinic Journal of Medicine2004;71(1):47–56.

15. Ghotbi N at al. Cancer screening withwhole-body PET/CT for healthyasymptomatic people in Japan: re-evaluation of its test validity and radiation exposure. Asian Pacific Journal of Cancer Prevention 2007;8:93–97.

16. Furtado CD et al. Whole-body CTscreening: spectrum of findings and recommendations in 1192 patients. Radiology 2005;237:385–94.

17. Obuchowski N, Modic MT. Total bodyscreening: predicting actionable findings.Academic Radiology 2006;13:480–85.

18. Decker K, Harrison M, Watters K.Manitoba Breast Screening Program Biennial Report 2004–2006. Winnipeg,Manitoba: Cancer Care Manitoba, 2007.

19. Ono K et al. The detection rates and tu-mor clinical/pathological stages of whole-body FDG-PET cancer screening. Annalsof Nuclear Medicine 2006;21(1):65–72.

20. Obuchowski NA et al. Total-bodyscreening: preliminary results of a pilotrandomised controlled trial. Journal of theAmerican College of Radiology2007;4:604–11.

21. Beinfeld MT, Wittenberg E, GazelleGS. Cost-effectiveness of whole-body CTscreening. Radiology 2005; 234:415–22.

http://tinyurl.com/y9h9cz3

http://www.canadadiagnostics.ca/private/preventative-health-scans.php


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

Sixty years of WHO in Europe

World Health Organization

Copenhagen: World Health Organization, Regional Office for Europe, 2010

ISBN 978 92 890 1417 5

70 pages

Freely available online at:www.euro.who.int/Document/E93312.pdf

This publication provides an overview of WHO’s activities in the Regional Office for Europe over thelast sixty years. The report begins with a look at howCopenhagen was chosen as the base for operations, andthen provides a historical analysis of the attributes ofeach of the five former directors, their major achieve-ments and projects. This information is placed within thecontext of changing socioeconomic and health chal-lenges, particularly in the 1960s. A substantial propor-tion of the report is dedicated to outlining major eventsof the past ten years. For example, the Health and Sta-bility Pact of 1999 and WHO’s increased efforts to con-tain the impact of humanitarian disasters upon health.Cases discussed include: avian influenza in Turkey; ab-normally cold weather in Tajikistan; lead poisoning inKosovo; mass immunisation in Ukraine; and polio erad-ication.

The report also serves to summarise milestones createdby WHO European conferences. In addition to the 2008WHO Ministerial Conference on Health Systems, sixothers are discussed in terms of goals set and achieved.Important international partnerships and internalchanges are presented. Additional information pages,references and web links are chronologically provided.

The socioeconomic impact of interoperable electronic healthrecords (EHR) and ePrescribing systems in Europe and beyond

Alexander Dobrev, Tom Jones, Karl Stroetmann, Yvonne Vatter, Kai Peng

Brussels: European Commission, DG Information Society & Media, 2009

54 pages

Freely available online at: www.ehr-impact.eu/

EHR IMPACT is the last element of an EU commis-sioned study that comprised nine quantitative and twoqualitative independent evaluations of good practicecases on interoperable electronic health record and ePrescribing systems in Europe. The study aimed toimprove awareness and provide evidence on the socio-economic and financial impact of EHRs. To this end thereport presents a conceptual framework within whichpractice can be analysed. Study sites include systemsimplemented over the last twelve years from all over Eu-rope (UK, Switzerland, Bulgaria, Spain, Czech Repub-lic, France, Italy), in addition to the USA and Israel.

Cost benefit analysis and sensitivity analysis are used asthe methodological foundation for the report, whichindicates that EHRs are beneficial but need net cash injections to be effective. In all cases it is shown that socioeconomic gains outweigh costs and typically takebetween four and nine years to produce net returns.Health care providers shoulder the majority of costsbut are also the main winners. Crucially, the impor-tance of information sharing – ‘interoperability’ – formsa vital backbone of EHR and ePrescribing systems, withcontinuous engagement a necessary precursor to suc-cessful implementation. The report provides advice forpolicymakers, with strategic recommendations of note.

Contents:

Introduction

The road to Copenhagen

1949–1956: Dr Norman Begg:the First Regional Director

1956–1966: Dr Paul van deCalseyde: the Second RegionalDirector

1966–1985: Dr Leo A. Kaprio:the Third Regional Director

1985–2000: Dr Jo E Asvali: the Fourth Regional Director

2000–2010: Dr Marc Danzon:the Fifth Regional Director

Epilogue

Information sources

Contents:

Executive summary

Introduction

Definitions

Approach and methodology

Synthesis of outcomes

Acknowledgements

References


http://www.euro.who.int/Document/E93312.pdf

http://www.ehr-impact.eu/


Please contact Azusa Sato [email protected] to suggest web sites for

potential inclusion in future issues.

Health Services Research –Europe

www.healthservicesresearch.eu

Health and Environment Alliance (HEAL)

www.env-health.org/a/2837

Spanish EU Presidency

http://eu2010.es/en/unioneuropea/politicas/empleo/

The Brussels based HEAL aims to raise awareness of how environmental protection improves health.It represents sixty-five social and professional organisations across Europe. Issues of particular con-cern include the environment and health policy; mercury and health; chemicals; pesticides; climatechange; air quality; public participation and environmental diseases. The website has a dedicatedmembers’ only area, and resources which include media coverage, book reviews, publications and pho-tos. Users can sign up for environmental health news and news feeds. Contact details and external linkscan be found online.

CALL for InterOPErability,(CALLIOPE)

www.calliope-network.eu

CALLIOPE is a network of collaborating organisations mandated with the planning and implemen-tation of eHealth. It has representatives from national governments, eHealth competence centres andeleven EU-level stakeholder organisations of health professionals, patients, health insurers and indus-try. The web site identifies and outlines key priority areas and encourages knowledge sharing and collaborations amongst stakeholders. Those interested can join Calliope online and consequentlysubscribe to newsletters and remain informed of future events. Event reports, newsletters and other ma-terial are downloadable. There is also a frequently asked question section.

European Policy Centre(EPC)

www.epc.eu

The EPC is an independent think tank comprising over four hundred international members whichaims to provide policy makers with high quality information on a range of issues including health andlong term care. It organises a series of events, reports of which are subsequently made available on thewebsite. Key publications and some keynote speeches are also available. A calendar allows users tosearch for future events.

January 1, 2010 marked the beginning of Spain’s presidency of the European Union. The Employment,Social Policy, Health and Consumer Affairs (EPSCO) council site brings together objectives, policiesand external resources. A calendar directs users to search for upcoming events. Links to the main EUsite and the Spanish presidency in focus are also accessible, including a detailed list of specific health pri-orities. A search facility for downloads is available for documents, news and key agenda items. The siteis available in Spanish, Catalan, Galician, Basque, English and French.

Health Services Research-Europe is an European Commission funded consortium, coordinated by theNetherlands Institute for Health Services Research (NIVEL) and involving four other major health services research institutes, which aims to identify, evaluate and improve the contribution of health serv-ices research (HSR) to the health policy process both at the national and EU levels. This focuses on fiveareas: health (care delivery) systems; health care organisations and professional practices; health tech-nology assessment; benchmarking & performance indicators; and relationships between research & pol-icy. One major activity is a forthcoming conference in the Hague on 8–9 April 2010, where the HSRcommunity and decision makers will meet to set an agenda for European HSR and strengthen the re-search-policy infrastructure. The website also has a dedicated members-only area and search box. Usersare able to subscribe to a newsletter.

Social Dialogue

www.socialdialogue.net/en/index.jsp

Social Dialogue offers information on European employment and disability issues. The site is spon-sored by the European Commission and aims to raise awareness of innovative policies and practicesacross Europe to support people with disabilities. Information on policies, legislation and affiliated organisations are listed on the site under five main sections – IT & social dialogue; corporate social responsibility; lifelong learning; social inclusion and disability, and economic & social change. Recentnews items are outlined on the homepage, whilst a library and project databases allow users to searchfor relevant documents. A members’ only area is available. The site is accessible in Greek, English,French and German.

WEBwatch


http://eu2010.es/en/unioneuropea/politicas/empleo/

http://www.healthservicesresearch.eu

http://www.env-health.org/a/2837

http://www.calliope-network.eu

http://www.epc.eu

http://www.socialdialogue.net/en/index.jsp

NEWS FROM THE INSTITUTIONS

European governments adoptplan to reduce environmentalrisks to health by 2020The Fifth Ministerial Conferenceon Environment and Health:“Protecting children’s health in achanging environment”, organ-ised by the World Health Organ-ization (WHO) Regional Officefor Europe and co-hosted byItaly’s Ministry of Health andMinistry for the Environment,Land and Sea took place inParma, Italy on 10–12 March2010. Focused on protecting chil-dren’s health, the Conferenceaimed to drive Europe’s agendaon emerging environmentalhealth challenges over the nextten years.

More than ever, children’s healthis at risk from a changing envi-ronment. The health impacts ofenvironmental risk factors – in-adequate water and sanitation,unsafe home and recreational en-vironments, lack of spatial plan-ning for physical activity, indoorand outdoor air pollution, andhazardous chemicals – are ampli-fied by recent developments suchas financial constraints, broadersocioeconomic and gender in-equalities and more frequent ex-treme climate events. They posenew challenges for health systemsto reduce deaths and diseasesthrough effective environmentalhealth interventions.

Evidence is growing that climatechange is contributing to an in-crease in the frequency of naturaldisasters, such as heat-waves,floods and droughts. Since 1990,the International Disaster Data-base (EM-DAT) has recordedmore than 1200 natural events inthe WHO European Region, af-fecting over 48 million people andcausing more than 112,000deaths, at an estimated loss ofmore than US$ 241 billion.

Pledge to reduce health impactof environmental threatsAll 53 Member States of theWHO European Region adopteda declaration pledging to reduce

the adverse health impact of en-vironmental threats in the nextdecade. Future work will bebased on a new European re-gional framework for action, en-titled “Protecting health in an en-vironment challenged by climatechange”. The document providesa comprehensive roadmap layingout steps and priorities for coor-dinated international and nationalaction.

Through the Declaration andCommitment to Act, participat-ing governments agreed to imple-ment national programmes toprovide equal opportunities toeach child by 2020 by ensuringaccess to safe water and sanita-tion, opportunities for physicalactivity and a healthy diet, im-proved air quality and an envi-ronment free of toxic chemicals.Governments also pledged toplace health at the centre of socio-economic development throughincreased investment in new tech-nologies and green jobs. StefaniaPrestigiacomo, Italian Ministerfor the Environment, Land andSea, noted that “environment andhealth objectives can also serve asan engine to boost innovation andcompetitiveness”.

Delegates also underlined that thehealth sector, one of the most en-ergy-intensive sectors in all coun-tries, should lead moves to reducegreenhouse gas emissions in thepublic sector by rationalising en-ergy use. They also agreed tostrengthen early-warning surveil-lance and preparedness systemsfor extreme weather events anddisease outbreaks.

“We need a radically new visionfor European health policy to ad-dress the biggest health challengesof our Region. This Conferencehas opened an exciting new chap-ter in the way European govern-ments work on environment andhealth, helping to push theseclosely inter-related issues higherup the political agenda,” statedZsuzsanna Jakab, WHO Re-gional Director for Europe. In themeantime, John Dalli, EuropeanCommissioner for Health andConsumer Policy promised thatthe European Commission will

“play its part by continuing tofocus attention across EuropeanUnion policies on environmentalimpacts on health.”

In September 2010, MemberStates will gather in Moscow forthe sixtieth session of the WHORegional Committee for Europeto endorse the outcomes of theconference through a resolution.Governments gathered in Parmaalso agreed to strengthen politicalcoordination between regularministerial conferences, and willnow involve ministers directly insteering the process to ensure thatcross-sectoral issues are given thehighest possible political profile.

More information on the conference is available atwww.euro.who.int/parma2010

EU ministers outline 2020 visionfor eHealthThe eighth Ministerial eHealthConference, co-organised by theSpanish Presidency of the Euro-pean Union and the EuropeanCommission, in cooperation withthe Regional Government of Cat-alonia and the Foundation Tic-Salut, was held in Barcelona on15–18 March 2010. EU ministersoutlined a joint vision and policypriorities on how to makeeHealth more accessible, interac-tive and customised to patientsover the next ten years.

Their Declaration called for pol-icy coordination amongst the var-ious areas where eHealth canhave an impact on citizens’health, in order to enhance bene-fits for patients, health care sys-tems and society. It also recog-nised the need for strongersynergies with policy areas likecompetitiveness, research and re-gional development, both at Eu-ropean and national levels.

The importance of eHealth, theynoted, should be underlined inthe framework of the future EU2020 Strategy and the EuropeanDigital Agenda. They noted thatinformation and communicationtechnology (ICT) tools for healthshould be used to scale up bene-fits to patients, health care sys-tems and society. Large scale ac-

Press releases andother suggested in-formation for futureinclusion can be emailed tothe editor David McDaid [email protected]


MONITOR

New

s

http://www.euro.who.int/parma2010


tions at European level to link research, in-novation and deployment were thereforewelcomed. The Commission should re-port on progress in this area. The signato-ries also underlined the importance of in-volving all stakeholders in the strategicplanning, validation and implementationof eHealth.

The Ministerial Conference is the lateststep in more than two decades of supportfrom the European Commission duringwhich time more than 450 projects, at acost of €1 billion, have been funded. Since2007 the European Commission has beensupporting eHealth deployment via theCompetitiveness and Innovation Pro-gramme and over the last year throughthe Public Health Programme.

More information on the High-Levelconference and World of Health IT conference can be accessed atwww.ehealthweek2010.org/

New legislation to reduce injuries forhealth care workers in EuropeEU Employment and Social Affairs Min-isters on 8 March 2010 adopted a Directiveto prevent injuries and infections to healthcare workers from sharp objects such asneedle sticks. This is one of the most seri-ous health and safety threats in Europeanworkplaces, estimated to cause one millioninjuries each year. The legislation specifi-cally addresses one of the priority objec-tives of the EU’s current strategy forhealth and safety at work, which aims tocut workplace accidents by 25% by 2012.

The Directive translates into Communitylaw an agreement negotiated by the Euro-pean social partner organisations in thesector, which employs around 3.5 millionpeople. Speaking at the Council of Minis-ters meeting, László Andor, EU Commis-sioner for Employment, Social Affairs andInclusion said that “the health care sectoris one of the biggest employers in Europeand needles represent a real risk to work-ers, both in terms of injuries and increasedrates of life-threatening infections likeHIV or hepatitis”. He added that the“new Directive will better protect work-ers and their families while reducing theburden of injuries on European healthservices.”

The new Directive implements in law aframework agreement on prevention fromsharp injuries in the hospital and healthcare sector signed in July 2009 by the Eu-ropean Public Services Union (EPSU) andthe European Hospital and Healthcare

Employers’ Association (HOSPEEM) –European Social partner organisations. Itaims to achieve the safest possible workingenvironment for employees in the sectorand protect workers at risk, as well as pa-tients; prevent injuries to workers causedby all types of sharp medical objects (in-cluding needle sticks); and set up an inte-grated approach to assessing and prevent-ing risks as well as for training andinforming workers.

More information at www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/113210.pdf

One in seven sunbeds in breach of UVradiation safety limitsConsumers need to be more aware of thepotential risks associated with usingsunbeds according to the results of a mar-ket surveillance check of sunbeds andsunbed services, published on 12 February2010 by the European Commission.

In a project led by the Dutch Food andConsumer Product Safety Authority, mar-ket surveillance authorities in ten MemberStates (Belgium, Cyprus, Czech Republic,Denmark, Finland, Germany, Hungary,Latvia, the Netherlands and Poland) ex-amined safety information and advice pro-vided to consumers, the labelling ofsunbeds, and the availability of eye pro-tection and ultra-violet (UV) radiationemitted by sunbeds.

They inspected more than 500 sunbeds atover 300 locations (mostly tanning salonsand wellness centres) between September2008 and September 2009. Three mainproblems were found: UV radiation lim-its for sunbeds were violated in one inseven sunbeds made available at tanningservices; consumer guidance, including onthe hazards of UV radiation or prohibitingtheir use by under 18s was not provided;and there were insufficient warnings onthe sunbeds themselves (for example, thatUV radiation may cause injury).

As a result of their findings the projectparticipants recommended that: thereshould be more enforcement at the sourceof entry onto the market; further align-ment of the interpretation of the legal re-quirements; making consumers better in-formed about the hazards of tanning andhow to avoid them; and to increase thenumber of UV radiation checks for a morerepresentative measure of non-compliance(expected to be higher with more testing).

Member State authorities are now inten-sifying their work to ensure compliance

with all relevant safety legislation and theresults of the 2008/2009 check will feedinto a follow up project launched by au-thorities in twelve Member States to trainmore inspectors and improve informationfor consumers. The outcome of this proj-ect should be available at the end of 2011.The authorities are also working with thesunbed industry, which is itself developingtraining material for service providers suchas tanning studios.

More information athttp://ec.europa.eu/consumers/citizen/my_safety/sunbeds/index_en.htm

NEWS FROM THE EUROPEAN COURTOF JUSTICE

ECJ Opinion states UK prescribing incentives schemes are illegalOn 11 February, the European Court ofJustice (ECJ) provided an Opinion (C-62/09) to the High Court of Justice inEngland and Wales stating that prescribingincentive schemes operated by PrimaryCare Trusts (PCTs) in England were ille-gal under EU law. In his Opinion, Advo-cate General Nilo Jääskinen stated thatthe schemes have the deliberate and di-rect intention of promoting certain me-dicinal products within the NationalHealth Service (NHS) at the expense ofothers, and that the schemes thereforeamount to promotion. This relates specif-ically to Article 94(1) of European Direc-tive 2001/83, which covers the provisionof human-use medicines, including theiradvertising and promotion.

The ECJ Opinion was in response to ac-tion by the Association of the BritishPharmaceutical Industry (ABPI) againstthe Medicines and Healthcare ProductsRegulatory Agency (MHRA) in the Eng-lish High Court challenging the practice ofrewarding doctors financially for pre-scribing specific medicines. On 3 July2006, after the ABPI wrote to the MHRAexpressing concern about the incentiveschemes being implemented by PCTs, theMHRA had replied that, in its opinion,Article 94 covered incentive schemes “of acommercial nature” only. The ABPI dis-puted this interpretation and sought a re-view of the legality of the MHRA’s posi-tion in the High Court, which in turnasked the ECJ for an interpretation of Ar-ticle 94 before it could give judgement.

Furthermore, the UK had claimed that


MONITOR

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http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/113210.pdf

http://ec.europa.eu/consumers/citizen/my_safety/sunbeds/index_en.htm

the industry group was “not con-cerned…with preserving the independ-ence of doctors or with patient safety, butwishes instead to maximise the prescrip-tion, and therefore the sale, of brandedmedicinal products manufactured andmarketed by its members.” However, theAdvocate General responded that, in hisview, “the self-regarding nature of ABPI’smotives is legally irrelevant.” Moreover,he stated that the UK appears to be theonly Member State with prescribing in-centive schemes involving the substitu-tion of specific medicines, compared withother countries that provide other formsof financial incentive schemes to reducepharmaceutical costs.

Jääskinen emphasised that his proposedinterpretation of the law does not meanthat the NHS is precluded from control-ling expenditure on medicines. He didthough suggest that it may need to thinkabout other measures, such as governmentprice freezes, price reductions and the pro-motion of generics. This is not a full judg-ment, although the Opinion of the Advo-cate General will be considered as part ofa final decision on the issue, which is ex-pected later this year.

The full text of the Opinion can be accessed via www.curia.europa.eu

Legislation in France, Austria and Ireland fixing minimum retail prices forcigarettes infringes EU lawOn 4 March the ECJ ruled that legislationin France, Austria and Ireland fixing min-imum retail prices for cigarettes infringesEuropean Union law. The Commissionhad brought infringement actions beforethe Court of Justice against France (C-197/08), Austria (C-198/08) and Ireland(C-221/08), because it considered that thelegislation of these Member States con-cerning the fixing of minimum prices forsome manufactured tobacco products,namely cigarettes and other tobacco prod-ucts in the case of France, cigarettes andfine-cut tobacco for the rolling of ciga-rettes in the case of Austria and cigarettesin the case of Ireland, were contrary to Di-rective 95/59 which lays down rules on ex-cise duty affecting the consumption ofthose products.

The directive obliges Member States toimpose excise duty on cigarettes consistingof a proportional element calculated onthe maximum retail selling price, and aspecific element, the amount of which isfixed by reference to cigarettes in the mostpopular price category but which may not

be less than 5 % or more than 55 % of theamount of the total tax burden. The rate ofthe proportional excise duty and theamount of the specific excise duty must bethe same for all cigarettes. The directivealso provides that the manufacturers andimporters of manufactured tobacco are tobe free to determine the maximum retailselling price for each of their products(Article 9(1)).

According to the Commission, the legis-lation of those three Member States, whichimposes minimum prices correspondingto a certain percentage of the averageprices of the manufactured tobacco con-cerned (95 % in the case of France, 92.75% for cigarettes and 90 % for fine-cut to-bacco in the case of Austria and 97 % inthe case of Ireland) undermines the free-dom of manufacturers and importers todetermine the maximum retail sellingprices of their products and, correspond-ingly, free competition. That legislation istherefore contrary to the Directive.

In its judgement the Court recalled, first,that the directive seeks to ensure that thedetermination of the tax base of the pro-portional excise duty on tobacco prod-ucts is subject to the same rules in all theMember States but also to maintain thefreedom of manufacturers and importersto make effective use of the competitiveadvantage resulting from any lower costprices.

It considered that the imposition of a min-imum retail selling price means that themaximum retail selling price determinedby manufacturers and importers cannot, inany event, be lower than that obligatoryminimum price, and is therefore capable ofundermining competition by preventingsome of those manufacturers or importersfrom taking advantage of lower cost pricesso as to offer more attractive retail sellingprices.

The Court therefore held that a system ofminimum retail selling prices for tobaccoproducts cannot be regarded as compatiblewith Article 9(1) of Directive 95/59 unlessit was structured in such a way as to en-sure, in any event, that the competitive ad-vantage which could result for some man-ufacturers and importers of those productsfrom lower cost prices is not impaired.

It concluded that national legislation didnot make it possible to ensure, in anyevent, that the minimum prices imposeddo not impair the competitive advantagewhich could result for some manufactur-ers and importers of tobacco products

from lower cost prices.

The Court rejected the arguments ad-vanced by each Member State in order tojustify its legislation. Its conclusion had nobearing on the Framework Conventionon Tobacco Control of the World HealthOrganisation (WHO), since it did not im-pose any actual obligation on the Con-tracting Parties with regard to the price oftobacco products which would allowthem to act contrary to the provisions ofthe directive. Moreover, the health pro-tection objective laid down in Article 30EC can be relied upon only to justify thequantitative restrictions on imports andexports and the measures having equiva-lent effect envisaged by Articles 28 ECand 29 EC. However, the Commissiondid not base its action on those provisionsof the EC Treaty.

Finally, the Court considered that Direc-tive 95/59 ensures health protection anddoes not prevent the Member States fromcombating smoking. It pointed out thatfiscal legislation is an important and ef-fective instrument for discouraging con-sumption of tobacco products and, there-fore, for the protection of public health,since the objective of ensuring that a highprice level is fixed for those products mayadequately be attained by increased taxa-tion of those products, the excise duty in-creases sooner or later being reflected in anincrease in the retail selling price, withoutundermining the freedom to determineprices.

The Court added that the prohibition onfixing minimum prices does not preventMember States from prohibiting the saleof manufactured tobacco at a loss, so longas the freedom of manufacturers or im-porters to determine the maximum retailselling prices for their products is not un-dermined. Those economic actors wouldnot be able, in that case, to absorb the im-pact of the taxes on those prices by sellingtheir products at a price below the sum ofthe cost price and all taxes.

The full text of the judgements can be accessed via www.curia.europa.eu

COUNTRY NEWS

Swedish regulator proposes environmental restrictions on pharmaceutical manufacturing In December 2008, the Swedish govern-ment commissioned the Swedish Medical


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Products Agency (MPA) to identify dif-ferent possibilities for strengthening theenvironmental requirements involved inthe manufacture of pharmaceutical prod-ucts. The MPA was instructed to under-take this project in consultation with theSwedish Environmental ProtectionAgency and the Swedish National Chem-icals Agency, and to focus on both na-tional and international perspectives.

In its final report published at the end of2009, the MPA makes proposals for en-vironmental measures designed to limitthe adverse environmental effects ofpharmaceuticals manufacturing. The Re-port of the Government Commission onstrengthening environmental require-ments in the manufacture of pharmaceu-tical products and active substances pro-poses that environmental protectionmeasures be encompassed into market-ing authorisation legislation at an EUlevel and into the pharmaceutical reim-bursement system at a national level.

It also proposes that an environmentalrisk assessment be included in the EU leg-islation on the authorisation of pharma-ceutical products. The MPA also proposedthat an environmental certification be in-troduced to the EU legislation on GoodManufacturing Practice (GMP) and that ata national level the review of the pharma-ceutical reimbursement system should in-clude environmental dimensions

In the 21st century, results from thisSwedish research indicate that emissionsfrom the manufacture of medicinal prod-ucts in India might seriously affect hu-man and animal health, as well as theirenvironment. Pharmaceuticals are foundin both ground- and drinking water. Cur-rent studies show that levels of pharma-ceuticals in ‘purified’ waste water areabove the level of a normal dose of a drugin a human being. With this background,the discharge of substances from the phar-maceutical production in the third worldis of serious concern.

A significant part of the current manufac-ture and production of raw materials orintermediate products takes place in lowincome countries and many large compa-nies are planning to place even more oftheir production there. National legisla-tion is insufficient and these measures arebetter met with harmonised EU legisla-tion, since the level of requirements alsomay affect conditions outside the EU.

The MPA therefore proposes, as a firstpriority, that a requirement for an envi-

ronmental certification of production fa-cilities, with respect to the production ofmedicines and active pharmaceutical in-gredients, be introduced to the legislationon GMP. This will ensure an environ-mental perspective in the legislation forimproved cleaning technology at produc-tion facilities.

In order to better reflect sustainable de-velopment in accordance with the ECTreaty, the MPA proposes that the currentEU legislation for the authorisation of me-dicinal products for humans should bechanged so that an environmental risk as-sessment is also included in the approval.

Today, authorities may not include envi-ronmental risk assessment in the risk/ben-efit analysis when assessing whether adrug will be approved for marketing au-thorisation. This means that current legis-lation does not allow a denial of authori-sation of medicinal products for humansdue to any risk of negative environmentaleffects. The Swedish government is nowconsidering the MPA’s proposals and po-tential actions.

The report is available in Swedish, withan English summary, athttp://tinyurl.com/y8unnwm

Czech Republic: New cardiovascularcare system introducedThe Ministry of Health, together with ex-perts from professional associations andhealth insurance companies, recently in-troduced a new cardiovascular care systemin the Czech Republic. As a result, a newcomplete network of Complex Cardio-vascular Centres will be established. Theywill become the guarantors of care for es-pecially costly or complex cases, includingcardio-surgery, invasive cardiology andheart transplants. The list of individualcentres and the level of care being pro-vided at each will be part of the Ministryof Health Bulletin to be published in 2010.

Cardiovascular diseases are the numberone cause of death in the Czech Republic.Every year over 50,000 people die of heartand circulatory system diseases, whichrepresent over half of overall mortality.Minister of Health, Dana Jurásková, saidthat “the concentration of personal andtechnical capacities for these diseases is arational step also recommended by theEuropean Union”. The First Deputy Min-ister of Health,, Marek Šnajdr, added that“concentrating care into a number of cen-tres is a key systematic step towards se-curing top cardiovascular care for all pa-

tients in the Czech Republic. It does notmean that centres will be closed down –instead, some will be selected to play therole of a guarantor of services for espe-cially costly and complex cases. In addi-tion, the centres in the network will playthe role of regional coordinators, whichhave to actively carry out research andapply new knowledge in day to day prac-tice.”

All the cardiovascular centres were care-fully evaluated by the Ministry of Health,experts from relevant specialisations (i.e.cardiology, cardio surgery, angelology,vascular surgery and interventional radi-ology) in August and September of 2009,focusing especially on human resources,technical and material equipment, effi-ciency, accreditation of doctors in differ-ent specialisations, participation in re-search and publications. The decisionabout which centres will be included in thenetwork was made in November 2009.

The Ministry of Health will support theessential modernisation of the new centresby helping to secure financial resourcesfor standard equipment from the struc-tural funds of the European Union as apart of the Integrated Operational Pro-gramme. The call for proposals was an-nounced on 16 February 2010.

Source: http://www.mzcr.cz

Slovakia: Reference pricing for pharmaceuticals The reference pricing of pharmaceuticals isconsidered to be the most importantachievement of the Slovak health care sys-tem in 2009, according to both the Minis-ter of Health, Richard Rasi, and theHealth Policy Institute, an independenthealth care think tank in Slovakia. Theeconomic crisis has significantly affectedthe health care sector and deprived healthinsurance companies of important rev-enues. Therefore, a 1.2% decline in phar-maceutical expenditures in the first halfof 2009 (a figure which is likely to remainconstant by the end of the year and is thesame as in 2008) was considered to be amajor achievement. This is particularlythe case given that drug expenditures inSlovakia represent approximately 30% oftotal health care expenditure. Accordingto the Ministry of Finance, savings in 2009totalled €71 million and are projected tobe €86 million in 2010. The former figurerepresents approximately 7% of total drugexpenditure in 2008.

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tributed to the Ministry of Finance whichproposed and implemented three roundsof reference pricing for pharmaceuticals.Slovakia is one of the first countries tohave implemented this reference pricingsystem. The system compares the six low-est prices in the European Union, takesthe average, and sets prices in Slovakia ac-cordingly. “This approach should bringabout important savings which can beredirected towards new drugs with proveneffectiveness”, said a spokesman from theMinistry of Health. The first three refer-encing rounds have indicated that brandeddrugs, the top 100 drugs according to con-sumption, and drugs for cancer and au-toimmune disorders, were the most over-priced. Referencing will continue to takeplace twice a year, in April and October.

Sources: www.hpi.sk and www.tasr.sk

Ireland: HSE National Service Plan2010 approvedThe Minister for Health and Children,Mary Harney, on 8 February announcedher approval of the Health Service Execu-tive (HSE) National Service Plan 2010.The Plan outlines how the HSE plans todeliver health and personal social serviceswithin its 2010 current budget of €14.069billion. It projects service activity levelsfor 2010 which are broadly in line with2009 levels. The Minister said “I welcomethe fact that the Plan commits to treatingpeople in a more effective way with no re-duction in access to appropriate services.By reducing costs, and reforming the wayservices are provided, I am confident theHSE will deliver the services people expectand continue to improve health outcomesfor the population.”

The Chairman of the HSE, Liam Downey,has welcomed the Minister’s approval.Despite current resource pressures, otherthan the changes to the delivery of hospi-tal based care, the same level of service as2009 will be maintained in 2010 withinthe context of health service reform, a rap-idly changing economic environment anda climate of reducing resources. TheHSE’s budget allocation for 2010 includesa reduction of over €500 million in respectof pay, this is in line with government paypolicy outlined in the national budget.

Acute hospital activity in 2010 will reflectthe continuing shift from inpatient to daycase activity, with an increase in day casesof 6.5% and a targeted reduction in thelevel of inpatient care provided of 5.6%over the 2009 targets. This will be achievedthrough a combination of continued re-

form in how health services are deliveredthrough measures such as minimisinglength of stay in hospital and more daycase procedures. Alternatives for people,who at present have to be admitted to hos-pital though emergency departments (ED)for very short hospital stays, will be metthrough the provision of more serviceswithin communities. The emphasis is on acontinued move towards treatment on aday case basis where this is clinically safeand in line with international best practice.

While the number of people who visit anED in 2010 is expected to remain con-stant, the HSE intends to reduce the num-bers who are admitted through EDs by33,313. This will be achieved by increasingaccess to the specialist skills and seniorclinical decision making available in EDsand in current and planned Medical As-sessment Units, which will mean that peo-ple do not need to be admitted to hospitalunnecessarily. In addition, by increasingaccess to diagnostics for the 10,000 peoplewho are admitted to hospital annuallysolely for this purpose, the reduction inadmissions can be achieved in 2010.

Speaking about the Service Plan, ProfessorBrendan Drumm, Chief Executive Officeof the HSE, said “our challenge this yearis to keep on enhancing the quality of theservices we provide, which can only beachieved by improving our effectivenessand in so doing, reducing costs”.

The National Service Plan 2010 can beaccessed at www.hse.ie/eng/services/Publications/corporate/NSP2010.html

England: Better NHS access to drugsand treatment for very rare conditionsPatients with very rare conditions will begiven access to drugs and services not pre-viously available on the national healthservice (NHS) in England, Junior HealthMinister Mike O’Brien announced on 19March 2010.

The proposals follow two consultationsand mean that a small number of drugsand treatments for very rare conditions,that are not yet appropriate for the Na-tional Institute for Health and ClinicalExcellence (NICE) appraisal process, cannow be considered for use in the NHS.

Access to these drugs and services will beincreased through two initiatives that aresupported by patient groups, NICE, theNHS and industry. The first is the creationof a three-year £25 million (€27.8 mil-lion) Innovation Pass pilot, as outlined inthe Office for Life Sciences (OLS) Blue-

print, to help patients with rarer diseasesaccess highly innovative new drugs whichare not yet appraised by NICE. The OLSBlueprint, published in July 2009, put for-ward a package of measures to help main-tain a competitive life science sector in theUK.

A Government notice of procurement willbe published in the Official Journal of theEuropean Union formally inviting ex-pressions of interest for the pilot. Drugsincluded on the Innovation Pass pilotscheme will be licensed and NICE willplay a key role in developing and applyingthe drug eligibility criteria for the Inno-vation Pass. All drugs included on the pi-lot will be submitted for NICE appraisalat the end of the three years.

A new expert advisory group will be setup to strengthen existing arrangements forcommissioning services nationally for ex-tremely rare conditions and to ensure thatthe system is more transparent and ro-bust. The group will have a wide range ofexpertise to take into account both clinicaland commissioning issues when assessingall treatments to be funded nationally. Itwill replace the National CommissioningGroup in its current form, incorporatingthe strengthened system.

Minister O’Brien said that he was ex-tremely pleased to see support for pro-posals that will make a real difference topatients with very rare and extremely rareconditions by helping improve access todrugs and services not previously availableto them. “Exciting, innovative new drugswhich will be included in the InnovationPass pilot scheme will mean that, with thehelp of NICE, the small number of pa-tients suffering from rarer diseases will beable to get access to a wider range of drugsand contribute to the collection of impor-tant data on their impact.”

More information available atwww.dh.gov.uk/en/MediaCentre/Pressreleasesarchive/DH_114325

England: NHS to provide more servicesat homeMeasures to shape NHS services in Eng-land around individual patients were setout on 18 February by Health MinisterAndy Burnham. Transforming how theNHS treats patients with long-term con-ditions, by providing more support inpeople’s homes and local community set-tings, means that people are able to bettermanage their health and avoid unnecessaryhospital visits. The Department of Health


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have estimated that improvements in themanagement of long-term conditions havealready led to efficiencies and savings of£2.1 billion.

Focussing on providing care at home canalso have a significant impact for socialcare. A report published on 18 Februaryby the Audit Commission indicated thatolder people who have the opportunityto be looked after in their own homes ifthey want, are happier and there are lesscosts to the taxpayer. There are already ex-amples of how being innovative can havesignificant outcomes and save money –for instance, for the cost of just onemonth’s care package a home can beequipped with sensors and pagers to helpa family look after a relative with demen-tia. Other measures include providingmore services at home for children andyoung people who have acute or long-term conditions or disability or palliativecare needs, and giving more people theoption to die at home if they wish to.

More dialysis at home and chemotherapyin the community would mean patientscan benefit from more convenient servicesthat help produce better outcomes andcan be more efficient. Around 7,000 pa-tients across England could benefit fromhome dialysis. Providing haemodialysis athome means that patients can tailor theirdialysis sessions around their lifestyle,which can lead to benefits such as betterblood pressure control, fewer admissionsto hospital and less reliance on medication.As well as benefits to patients, the annualcosts of home haemodialysis could be upto 25% less than providing dialysis in ahospital or renal centre, and can lead tolong-term savings once initial set-up costsare recovered.

Health Minister Andy Burnham said that“the time has come for the NHS to makea decisive shift in providing more care outof hospitals and in the patient’s commu-nity and home. For too long, services havebeen organised to fit the convenience ofthe system. A great NHS will put the con-venience of the patient first, and moveservices towards them where it is safe todo so. But care in the home can alsoachieve better results and save money.”

Jane Macdonald, President of the BritishRenal Society and Lead Nurse for RenalServices at Salford Royal FoundationNHS Trust said that the need for longterm dialysis undertaken either thriceweekly or in some cases daily has a signif-icant impact on the lives of dialysis pa-

tients, their families and carers. To be of-fered the choice, if clinically appropriate,to undertake dialysis at home is a majorfactor in eliminating frequent travel, max-imises time spent with family, and plays animportant role in remaining in employ-ment.”

The Department of Health has also pub-lished a guide for the NHS on developingchemotherapy services closer to home.Giving cancer patients the option of hav-ing chemotherapy at or closer to homewhere clinically appropriate, can benefitpatient experience and contribute to bet-ter outcomes. This follows the recent an-nouncement that all cancer patients willhave one to one support within five years.

Children and young people who haveacute or long-term conditions, or disabil-ity or palliative care needs, should be ableto spend less time in hospital and receivecare at home or in the community instead.Providing services for children and youngpeople at home can mean fewer unplannedvisits and shorter stays in hospital, reduc-ing distress for children, young peopleand their families.

As a next step, the Department of Healthwill be publishing the final version of theNational Framework for Children andYoung People’s Continuing Care veryshortly. This will help in assessing the con-tinuing health care needs of children andyoung people, and in considering the be-spoke packages of care that will be re-quired to meet those needs. The HealthMinister also confirmed plans to reviewprogress on End of Life Care by 2013,with the intention of setting out proposalsfor a right to choose to die at home in thefuture. The non-governmental organisa-tion, Marie Curie Cancer Care, is alreadypiloting a range of models through their‘Delivering Choice’ programme.

More information at www.dh.gov.uk

Spain: New law permits abortion without restriction up to 14 weeksOn 24 February the upper house of theSpanish Parliament voted in favour of leg-islation permitting abortion without re-striction up to 14 weeks into pregnancy.The Senate approved the law tabled byPrime Minister Jose Luis Rodriguez Zap-atero’s Socialist government with 132votes in favour, 126 against and one ab-stention.

The law had already been approved by thelower house of Parliament in December2009. The expansion of legal access to

abortion – which takes effect in June2010 – is part of a comprehensive lawaimed at improving universal access to sex-ual and reproductive health services andinformation, especially for young people.The new law grants 16- and 17-year-oldsabortion access, provided that they notifyat least one parent or legal guardian. No-tification is not required if they believe itwould result in “domestic violence,threats, coercion, abuse, or a situation ofuprooting or helplessness.” It also allowsabortion up to 22 weeks if there is a seri-ous risk to the health of the mother or ifthe foetus has serious abnormalities.

Spain’s new law also requires that publicpolicies related to health, education andsocial issues promote universal access tosexual and reproductive health servicesand programmes – including family plan-ning services – and makes comprehensivesexuality education mandatory in schools.Additionally, it requires public health fa-cilities to provide pregnancy-related careand effective family planning methods toall women and their partners.

Since 1985 abortion has been decrimi-nalised in Spain, but only in matters ofrape, or when the health of the child ormother is at risk. Abortions have doubledin the past decade in the traditionally Ro-man Catholic country, from nearly 54,000in 1998 to 115,000 in 2009. The law facesstrong opposition from Catholic and pro-life groups and from the conservative Pop-ular Party, the main political party in theopposition. Popular Party leaders haveannounced that they will repeal the newlaw if they win the next election.

Scotland: Free prescriptions a yearawayFurther progress towards abolishing pre-scription charges in Scotland will benefit600,000 people in low-income households.Regulations introduced to Parliament re-cently will see prescription charges fall to£3 (€3.34) from April 2010, if approved,on the road to full abolition in 2011.

Around 600,000 adults in households withan income of less than £16,000 (€17,800)are benefiting from the reductions, withhundreds of thousands more on modestincomes also finding prescriptions moreaffordable. Since the first reduction incharges in 2008, sales of Prescription Pre-Payment Certificates bought by peoplewith long-term conditions who need med-icines over a period of months have soaredby more than 150%. In the first sixmonths of the 2009/10 financial year


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alone, 236,000 were dispensed, comparedto just 93,000 in the same period of2007/08.

The regulations to further reduce pre-scription charges from £4 to £3 (€4.45 to€3.34), which will also see four-monthand twelve-month Prescription Pre-Pay-ment Certificates fall from £13 (€14.47)and £38 (€42.31) to £10 (€11.13) and £28(€31.17) respectively, were introduced toParliament on 6 January 2010. The HealthCommittee were expected to vote on theregulations in February. Under Parlia-mentary rules, the regulations must re-main in Parliament for 40 days, duringwhich time any Member of the ScottishParliament can lodge a motion suggestingthe proposals are rejected by Parliament.

Speaking ahead of her appearance at theHealth and Sport Committee on 3 Febru-ary 2010, Public Health Minister ShonaRobison said “we’re committed to scrap-ping prescription charges and removingthis tax on ill-health, which hits those onlow incomes hardest. We want our na-tional health service to be restored to itsfounding principles – free at the point ofdelivery and based on clinical need, notability to pay.” She added that “with Scot-land’s record of ill-health and our ap-palling health inequalities, it’s vital thatwe do all we can to help people get thehealth help they need – not put further fi-nancial hurdles in their way.”

Germany: Tension over health care reforms in coalition governmentOn 17 March, under the auspices of theFederal Health Ministry, the first meetingtook place of the new Government Com-mission on the Sustainable Financing ofHealth and Social Care. The Commission,which consists of eight government minis-ters, must put forward proposals on re-forms to the insurance system at a timewhen the country must contend with everincreasing costs and, according to the Ger-man Federal Insurance Office, an esti-mated €15 billion deficit in funding by2011. Overall German health care costsare estimated to be some €250 billion perannum.

Germany’s health care system instituted anew universal premium in January 2009.Set at 15.5% of an individual’s gross pay,it has turned out to be insufficient tomaintain the budgets of the country’sstatutory insurers. Many have begun put-ting extra fees on subscribers.

Major proposals for reform have now

been set out by Minister of Health, PhilipRoesler of the junior coalition govern-ment partner in 2011, the Free DemocraticParty (FDP). Controversially he has pro-posed a flat rate contribution to health in-surance irrespective of income. The sys-tem would break the link between healthcosts and labour costs. Keeping control ofGermany’s high labour costs has formed akey part of recent government efforts tobolster the nation’s international eco-nomic competitiveness.

Under the plan, the state would also sub-sidise the contributions made by the lesswell off, and anyone wanting more thanthe basic coverage could then top up withprivate health insurers. But critics havewarned that the reforms would mean atwo-class health system with patients cov-ered by basic insurance forced to pay forextra treatment out of their own resources.

Combined with tensions over tax cuts,Roesler’s proposals have led to cracksemerging in Chancellor Angela Merkel’sconservative-led coalition. Horst Seehofer,who heads up Merkel’s Christian De-mocrats’ (CDU) associate party, theBavarian-based Christian Social Union(CSU), has threatened to veto the move toreplace the existing wages-linked contri-butions scheme with a flat contribution.Despite support for the Roesler reformsemerging from the ranks of Merkel’sCDU, Bavarian CSU Health MinisterMarkus Soeder dismissed the proposal fora flat-rate contribution as “unfair and un-affordable”.

Defending the proposal however, VolkerKauder, parliamentary leader of the CDUparty, emphasised the need to implementa health care premium, explaining that thiswas agreed as part of the coalition agree-ment. German Chancellor Angela Merkelhas also provided her support for theHealth Minister, and has urged the coali-tion to put an end to the futile bickeringand feuding, and to allow the govern-ment’s commission time to carry out itsrole.

Other mooted reforms include a plan thatpharmaceutical companies should negoti-ate prices for pharmaceuticals with thehealth insurance funds. This the Ministercontends could reduce the costs of phar-maceutical expenditure by €2 billion perannum. The German daily newspaperSüddeutsche Zeitung also ran a story on20 March, suggesting that the governmentmay impose a three year freeze on theprice of pharmaceuticals. The price freeze

on drugs would be put in force quickly,according to the Süddeutsche Zeitung re-port. Mandatory discounts and a broadcomparison of German medication priceswith the international standard would be-gin next year.

The government’s commission is due topresent its proposals in the summer, in or-der that the anticipated reform can take ef-fect from 2011.

More information on the work of theCommission is available in German atwww.bmg.bund.de/cln_178/nn_1168682/DE/Gesundheit/Kommission/kommisssion__node.html?__nnn=true

Poland: plans for electronic health cardsannouncedIn an effort to radically reform andimprove the national health system thePolish government is planning tointroduce an electronic health man-agement system, which it is claimed willfacilitate easier access to health careservices.

The main directions for the developmentof e-Health have been set out in the e-Health Strategy for Poland 2009–2015.The e-Health Strategy includes four mainobjectives: facilitation of the access of cit-izens to information on health care;improvement in the effectiveness of elec-tronic documentation flow; modernis-ation of the health services demandanalysis system; and the establishment ofan ‘interoperational’ electronic healthrecord.

Starting in 2013, Poland will embark onissuing every citizen with an electronichealth card that will contain informationabout their health condition, medicaldiagnosis and any prescription given. Themedication data will be capable of beingread at a pharmacy, thus reducing risksarising from the difficulty of reading adoctor’s handwriting. A draft law oninformation systems in health care isbeing prepared. It will constitute the basisof a stable information system and helpclarify issues related to collecting, pro-cessing and using information.

The new system is expected by the gov-ernment to yield savings of about 4 billionzloty (approx. €1 billion) on an annualbasis. They claim it will eliminate phe-nomena of identity fraud. The reforms areexpected to cost 800 million zloty(approx. €197 million), 85% of whichwill be financed with EU support.


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Former WHO Regional Director for Europe Dr Jo E. Asvall dies It was announced with great sadnessthat Dr Jo Eirik Asvall, the WHORegional Director for Europe from 1985to 2000, died on 10 February 2010. Bornin Norway in 1931, his time as RegionalDirector was spent promoting andimplementing the Health for Allstrategy in the Region. This called for afundamental change in countries’ healthdevelopment and outlined four mainareas of concern: lifestyles, risk factorsaffecting health and the environment,the reorientation of health care systemsand the political, management, techno-logical, human resources, research andother support necessary to bring aboutthe desired changes in the first threeareas.

Remaining active during his retirement,his last public engagement was at theWHO Regional Office for Europe inJanuary 2010. “WHO was his life, hisworld, his passion. He was a true leaderin European health policy and publichealth. We owe him so much,” saidWHO Regional Director for Europe,Zsuzsanna Jakab. Dr Asvall is survivedby his wife, Kirsten Staehr Johansen.

Tributes can be sent by email to [email protected]

Up to 40% of cancer cases could beprevented, says WHOMarking World Cancer Day on 4 Feb-ruary 2010, the WHO Regional Officefor Europe highlighted the importancethat changes in lifestyle and improvedprevention and screening policies canhave in preventing up to 40% of allcancer cases.

It was noted that people can signifi-cantly reduce their cancer risk byavoiding risk factors (such as tobaccouse, heavy alcohol consumption, exces-sive sun exposure and obesity) andadopting healthier lifestyles. Moreover,as cancer incidence rates continue torise, governments have a crucial role inraising awareness and putting in placecomprehensive early detection measures.

“Well-conceived, effective nationalcancer control programmes are essentialto fight cancer and to improve the livesof cancer patients,” said ZsuzsannaJakab, WHO Regional Director for

Europe. She urged governments to “rig-orously implement the four basic com-ponents of cancer control – prevention,early detection, diagnosis and treatment,and palliative care.”

More information on World Cancer Dayat www.worldcancercampaign.org/

European Quality of Life Survey: Subjective well-being in EuropeDrawing on findings from the secondEuropean Quality of Life Survey carriedout by the European Foundation for theImprovement of Living and WorkingConditions in 2007, a new reportexplores factors that give rise to a feelingof satisfaction with one’s life and howthese vary from country to country.

Written by Dorothy Watson, FlorianPichler and Claire Wallace, the reportlooks at different aspects of an indi-vidual’s life – such as income, age,employment, marital status and health –and their impact on quality of life. Indoing so it gives a wide-ranging pictureof the diverse social realities in Europetoday.

The report is available athttp://www.eurofound.europa.eu/pubdocs/2009/108/en/1/EF09108EN.pdf

Scotland: Alcohol abuse costs everytaxpayer £900 a yearA new report, commissioned by theScottish Government and authored by ateam from the University of York, hasrevealed that alcohol misuse could becosting Scottish taxpayers up to £4.6 bil-lion a year in costs to health and socialwelfare services. The report indicatesthat crime-related costs resulting fromalcohol misuse can be as much as £727.1million, while the human costs causedby suffering through premature deathwere estimated to be £1.46 billion.

The report is available at www.scotland.gov.uk/Resource/Doc/297819/0092744.pdf

European Medicines Agency consultation The European Medicines Agency isengaged in a public consultation on itsfuture strategic vision, set out in thedocument The European MedicinesAgency Road Map to 2015: The Agency'scontribution to Science, Medicines,

Health. Building on the achievementsmade by the previous Road Map initia-tive between 2005 to 2010, the focus ofthe new Map is on continuous high-quality delivery of the Agency’s corebusiness in an increasingly complex reg-ulatory and scientific environment. Inaddition, the document proposes threepriority areas – addressing public health,facilitating access to medicines, and opti-mising the safe use of medicine – forfuture actions to strengthen theAgency’s role in protecting and pro-moting human and animal health in theEuropean Union. Comments on RoadMap should be sent to the Agency by 30April 2010.

More information on the Road Map andconsultation at www.ema.europa.eu/htms/general/direct/roadmap/roadmapintro.htm

Snapshot on the health of womenA new report prepared for the EuropeanCommission by the Faculty of MedicineCarl Gustav Carus, the Research Asso-ciation Public Health Saxony andSaxony-Anhalt, the Technische Univer-sität Dresden, Germany, provides asnapshot of the health of women acrossthe EU and some additional countries inthe European Economic Area.

Key findings include the recognitionthat breast cancer remains the mostcommon form of cancer and cancer-related death amongst women. Depres-sion, Alzheimer’s Disease, arthritis,osteoporosis and diabetes are also ofconcern. The report concluded that,despite much work in recent years, notenough reliable and relevant data isavailable by gender. It recommendedmore investment in the implementationof standardised gender-specific data col-lection across the EU.

The report is available athttp://ec.europa.eu/health/population_groups/docs/women_report_en.pdf

eurohealth Vol 15 No 4 48

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6 Philippe Le Bon, Brussels.Tel: + 32 2 235 03 20Fax: + 32 2 235 03 39Email: [email protected]


http://www.worldcancercampaign.org/

http://www.eurofound.europa.eu/pubdocs/2009/108/en/1/EF09108EN.pdf

http://www.scotland.gov.uk/Resource/Doc/297819/0092744.pdf

http://www.ema.europa.eu/htms/general/direct/roadmap/roadmapintro.htm

http://ec.europa.eu/health/population_groups/docs/women_report_en.pdf


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Eurohealth, Vol 15, No.4, (2009) - World Health Organization · Maria Lluchis reading for a PhD, LSE Health, London School of Economics and Political Science, UK. Angela Mehtais Finances