EurohealthVolume 16 Number 4, 2010RESEARCH • DEBATE • POLICY • NEWS
HTA and implantable medical devices in Greece, Poland and Serbia • Croatia: pharmaceutical reformNetherlands: managed competition • Spain: pharmaceutical consumption
NHS engagement with European affairs
Institutional overviewon EU law and thehealth care sector
European Union lawand health
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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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EU law and health
Recently, the European Court of Justice has providedOpinions on a range of disputes related to health, from orphan drug designation to reimbursement of health careabroad. Despite European Union Member States havingthe authority to make their own health service decisions,they must still implement European Directives into national law or risk being held to task.
In the first section of this issue, Rachel Irwin reports froma 2010 meeting organised by LSE Health and the NationalHealth Service (NHS) Confederation on European UnionLaw and Health. She notes interestingly that non health-specific aspects of EU law are inclined to have the largestimpact on health and health care. Later, she poses twochallenges for health care providers and policy-makers: to understand how EU law affects the health system andto understand how to fully engage with it.
Following on, the institutional context of EU law andhealth is examined by Tamara Hervey. Among otherthings, she discusses the supremacy of EU law (how ittrumps national law) and the direct effect (how individualscan uphold the rights conferred from it in national courts).Also, Elisabetta Zanon points to the NHS European Office, established in 2007, to represent the various NHSstakeholders in European debates and also to monitor relevant developments. She explores the many challengesthat the NHS will face in implementing the provisions of the new European Directive on patients’ rights in cross-border health care.
Moving on to the assessment and uptake of interventionswithin the health sector, Miro Palat, President of theCzech medical device industry association (CzechMed),argues for broadening the scope of health technology assessment (HTA) to include all interventions used in prevention and treatment. Next, snapshots are providedfor three countries – Greece, Poland and Serbia – whichspecifically address HTA for implantable medical devices.For all countries, the authors present an overview of thehealth care system, pathways for the reimbursement ofmedical devices and offer prospects for the future.
In our Health Policy Developments section, we provide acouple of articles on pharmaceuticals including recent pol-icy reforms in Croatia and an analysis of pharmaceuticalconsumption in Spain. On health systems, the challengespresented by the introduction of managed competition in the Netherlands are discussed by van Ginneken and colleagues, while van den Berg and colleagues identify the tradeoffs that come to light when assessing the performance of the system.
Sherry Merkur Editor David McDaid EditorPhilipa Mladovsky Deputy EditorLucia Kossarova Assistant EditorAzusa Sato Assistant Editor
MENT
EurohealthCOM
Contents EurohealthVolume 16 Number 4
Predrag Djukic is Consultant, Project CoordinationUnit, Ministry of Health, Belgrade, Serbia.
Richard Heijink is Researcher, University of Tilburgand the National Institute for Public Health and the Environment (RIVM), the Netherlands.
Cristina Hernández-Quevedo is Research Officer, European Observatory on Health Systems and Policies, LSE Health, London School of Economics andPolitical Science, UK.
Tamara Hervey is Jean Monnet Professor of EuropeanUnion Law, School of Law, University of Sheffield, UK.
Rachel Irwin is Research Assistant, LSE Health, LondonSchool of Economics and Political Science, UK.
Dolores Jiménez Rubio is Associate Professor, Department of Applied Economics, University ofGranada, Spain.
Madelon Kroneman is Senior Researcher, NetherlandsInstitute for Health Services Research, the Netherlands.
Nikos Maniadakis is Professor and Department Director, Health Services Organisation and Manage-ment, National School of Public Health, Greece.
Maciej Nowicki is President, HTA Audit NowickiLanda Partners, Poland.
Miro Palat is President of CzechMed, Prague, CzechRepublic.
John Relakis is Doctoral Researcher – Research Fellow,Health Services Organisation and Management, National School of Public Health, Greece.
Willemijn Schäfer is Researcher, Netherlands Institutefor Health Services Research, the Netherlands.
Tihomir Strizrep is Managing Director, Croatian Institute for Health Insurance, Zagreb, Croatia.
Michael van den Berg is Researcher, RIVM, theNetherlands.
Ewout van Ginneken is Senior Researcher, Departmentof Health Care Management, Berlin University of Technology, Germany.
Harry Verkleij is Researcher, RIVM, the Netherlands.
Luka Voncina is Head of Department for Drugs andMedical Products, Croatian Institute for Health Insurance, Zagreb, Croatia.
Gert Westert is Head of IQ-healthcare and Professorat Radboud University, Nijmegen, the Netherlands.
Elisabetta Zanon is Director of the NHS European Office, Brussels, Belgium.
Laurens Zwakhals is Researcher, RIVM, the Netherlands.
EU law and health1 EU law and health: an introduction
Rachel Irwin
3 The NHS’ engagement with European affairsElisabetta Zanon
5 The impacts of European Union law on the health care sector:Institutional overviewTamara Hervey
Health Technology Assessment8 Debate: Is HTA going to save health care budgets or are its
premises inherently flawed?Miro Palat
11 Developing HTA frameworks in emerging markets: the roadahead. The case of GreeceJohn Relakis and Nikos Maniadakis
14 Developing HTA frameworks in emerging markets: the roadahead. The case of SerbiaPredrag Djukic
16 Developing HTA frameworks in emerging markets: the roadahead. The case of PolandMaciej Nowicki
Health policy developments18 Spain: the effect of country of birth on patterns of
pharmaceutical useDolores Jiménez Rubio and Cristina Hernández Quevedo
20 Croatia: 2009/2010 pharmaceutical pricing and reimbursement reformLuka Voncina and Tihomir Strizrep
23 Managed competition in the Netherlands: an example for others?Ewout van Ginneken, Willemijn Schäfer and Madelon Kroneman
27 Health care performance in the Netherlands: Easy access, varying quality, rising costsMichael van den Berg, Richard Heijink, Laurens Zwakhals, Harry Verkleij and Gert Westert
Monitor30 Web Watch
31 Publications
32 News from around Europe
Eurohealth Vol 16 No 41
EU LAW AND HEALTH
Health is never just about healthHealth is never about just about health.Addressing nutrition-related chronicdisease involves transport policy, foodlabelling and advertising, agriculture andeducation policies and always the financeministry to look at the financial implica-tions of these other policies. Similarly, inon-going debates on access to medications,policy-makers are constantly balancingtrade and health policies.
The role of the European Union in healthprovides another clear example of theintersectorality of health policy. Recog-nising the need for intersectoral action andthe impact of non-health policies on health,the Finnish government started the Healthin All Policies initiative during their presi-dency in 2006. After all Article 152 of theTreaty of Amsterdam states that “a highlevel of human health protection shall beensured in the definition and implemen-tation of all Community policies andactivities.” Good health and well-being inthe population contributes to prosperity,solidarity, safety and social cohesion. Goodhealth also helps in the continuation ofwhat many deem to be core Europeansocial values.
Direct and indirect impactsHowever, despite these provisions, theaspects of EU law which have had thegreatest impact on health and health careare not health-specific. Under the principleof subsidiarity individual Member Statesare responsible for the delivery of healthcare and the design of health care systems.The EU only becomes involved wherecooperative action can be more effective,or in the case of specific cross-borderissues, including international healththreats, such as pandemics or bioterrorism.Specific areas in which there are relevantEU directives include food safety andquality standards for blood, organs and
tissue. However, in many ways both theWorld Health Organization’s InternationalHealth Regulations and the FrameworkConvention on Tobacco Control thatsupersede European law, have removedsome, albeit not all, of the need forEuropean law in some areas.
The internal market ensures the freemovement of goods, services and people,with consumer protection. The EU’simpact on health comes primarily underlegislation to ensure these freedoms:mobility of workers (including health careworkers) and mobility of people (and dis-agreements over cross-border health care).Labour directives on the length of workingtime and worker safety and procurementlegislation apply to many health careproviders in the same way they apply toother sectors.
That European law about health is notreally about health is partly by design. The‘European Experiment’ began as an eco-nomic and trade union – not a union forsocial protection. This history has conse-quences to this very day. For instance, therole of the Directorate-General for Healthand Consumers is relatively weak in com-parison to the other Directorate-Generals.Although it oversees the work of theEuropean Food Safety Agency, most of theday-to-day work on food safety lies withinthe Agency. Similarly, the EuropeanCentre for Disease Control is in no waycomparable to its US counterpart. One ofthe more influential European healthbodies is the European Medicines Agency,but impetus here lies in upholding the freemovement of goods.
Arguably the biggest impact the EU has onhealth directly is in its funding. From2008–2013, the 7th Framework Pro-gramme for Research is giving out €53 billion to projects on basic research, aswell as for health and some public healthresearch. The current Community HealthProgramme (2008–2013) is funding €321 million of health activities and programmes, while other health-relatedwork is funded by the Consumer Programme and the Fundamental Rights
and Justice Programmes.
Although not hard law, the EU also runsstrategies that can have influence, bothwithin member states, as well as interna-tionally. For example, the EuropeanCommunity Health Indicators (ECHI)project aimed to standardise health datacollected across member states. TheEuropean Platform on Diet, PhysicalActivity and Health brought togetherpolicy-makers, consumer groups andprivate industry to address obesity andother nutrition-related non-communicabledisease. Regardless of one’s views on theusefulness or legitimacy of public-private-government partnerships, this approach isviewed globally by many as a model foraction. Similarly, out of the Strategy onNutrition, Overweight and Obesityemerged directives on food labelling,nutrition claims and limits on the adver-tising of sugary food to children. What wethink of as health issues tend to be handledthrough ‘soft’ law and initiatives, while‘hard’ law impacts upon health and healthcare in more unexpected ways. Both havetheir place.
Two articles in this issue of Eurohealthexamine some aspects of the impact of EUlaw upon health and health care. Both arebased on presentations at a seminar jointlyorganised by LSE Health and the NationalHealth Service (NHS) Confederation andfunded by the Higher Education Inno-vation Fund of the UK’s Department forBusiness, Skills and Innovation. Theseminar took place at the Confederation’sAnnual Conference in Liverpool in June2010. Its overall theme was to examinehow EU directives, regulations and otheractivities impact on the range of NHSactivities and also to understand how NHSorganisations – and by extension healthcare organisations in other member states– can engage more fully with Europeanpolicy-makers.
Tamara Hervey from the University ofSheffield provides a general overview ofEU law and competencies and how theseare integrated and enforced within nationalpolicies. She focuses on laws upholding the
EU law and health: an introduction
Rachel Irwin
Rachel Irwin is Research Assistant, LSEHealth, London School of Economics andPolitical Science, UK. Email: [email protected]
free movement of people, goods andservices and competition law, looking athow these can affect health care practice inmember states. Meantime, the NHSEuropean Office's Elisabetta Zanon dis-cusses what national health organisationsneed to know about EU law and also howthey can engage with policy-makers andother actors on the European level. Thelatter is needed not only to ensure one’sorganisation is following the rules, but alsoto facilitate the exchange of knowledge andbest practice and to influence the policyprocess through formal and informalchannels.
Free movement, competition and procurementIn addition to these articles, anotherimportant perspective at the seminar wasprovided by Leigh Hancher from theinternational law firm Allen and Overy’sAmsterdam office. She examined rulesgoverning free movement, competition andprocurement and how these affect indi-vidual health systems. Free movementrules apply to national governments and toassociations that are given policy tasks,such as professional associations for phar-macists or physicians. These includepatient mobility and patient rights. TheEuropean Court of Justice interprets theserules very widely; in general, states are freeto regulate themselves, but must take freemovement as the starting point and thenjustify any limitations on this. Forexample, states may argue that too manyproviders will create excess demand. In herpresentation Hancher cited the Perez casein which the licensing law in Andalucia onestablishing a pharmacy limited thenumber of pharmacies per person.However it was ruled by the EuropeanCourt that if a national from another statewas able to set up a pharmacy, so couldsomeone from within Spain. That is, theEU law necessitates freedom of mobilityboth across and within member states.
Competition and state aid rules apply tofirms/undertakings. In general, an under-taking is an entity which provideseconomic services; typically it does notcover health bodies but this is not alwaysthe case. Similarly, competition rules canapply to member states in certain circum-stances, even though they are notundertakings. These are ‘fuzzy’ categoriesand an entity – such as a health provider –can be an undertaking in some of its activ-ities and not in others. Competition rulesexist to combat cartels and abuses of dom-inant positions, for example pharma-
ceutical companies which register theirproducts strategically in different marketsto extend the lifetime of their patents. Stateaid rules only apply to undertakings and insituations when public and privateproviders are competing, the private sectormay complain on how the public sector isoperating, as the public sector is generallyimmune from fines and other types of regulation.
With regard to procurement Hancher alsonoted that the distinction between under-takings and non-undertakings isparticularly important because these direc-tives only apply to not-for-profitorganisations because competition law inaddressing the same issues covers under-takings. However, the logic behindprocurement law is to promote freemovement. Thus, not-for-profit entitiesmust also advertise properly and allowundertakings from abroad to tender. Otherspecific policies that will affect nationalhealth care providers include new climatechange legislation on energy savings,which also affect procurement strategies.
ConclusionsAs all presentations at the seminar, andboth detailed articles here explain, overallEU law is a piecemeal amalgamation ofdirectives, regulations and European Courtof Justice rulings. It involves input fromthe European Parliament, European Com-mission and Council of the EuropeanUnion, as well as external pressure fromthe Council of Europe and interest groups.The challenge for national health careproviders and policy-makers is two-fold:firstly, to understand how this system oflaw and policy-making affects the workthey do and secondly, to understand howto fully engage with it, as increased EUengagement also provides ample opportu-nities for funding and cross-borderknowledge exchange.
A podcast and presentations from thesession at the NHS Confederation con-ference in Liverpool are available athttp://www2.lse.ac.uk/LSEHealthAndSo-cialCare/LSEHealth/eventsAndSeminars/EU%20Law.aspx
Eurohealth Vol 16 No 4 2
EU LAW AND HEALTH
This new report from the World Health Organizationaims to present current knowledge on how eco-nomic downturns affect population mental healthand outlines some of the benefits of action thatcould be implemented to reduce the harmful effectson mental health of the current economic crisis.
The economic crisis is expected to produce secondary mental health effects that may increasesuicide and alcohol-related death rates. However,the mental health effects of the economic crisis canbe offset by social welfare and other policymeasures, for example:
• Active labour market programmes aimed athelping people retain or regain jobs counteractthe mental health effects of the economic crisis.
• Family support programmes contribute to coun-teracting the mental health effects of the crisis.
• Increasing alcohol prices and restricting alcoholavailability reduce the harmful effects on mentalhealth and save lives.
• Debt relief programmes will help to reduce themental health effects of the economic crisis.
• Accessible and responsive primary care servicessupport people at risk and prevent adversemental health effects.
Kristian Wahlbeck, Peter Anderson,Sanjay Basu, David McDaid, David Stuckler
Impact of economic crises on mental health
Copenhagen: World HealthOrganization Regional Office forEurope, 2011
http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/mental-health/publications/2012/impact-of-economic-crises-on-mental-health
Eurohealth Vol 16 No 43
EU LAW AND HEALTH
EU policy and legislation are having anincreasing impact on NHS organisations,not only as providers and commissionersof health care, but also as employers and asbusinesses. EU laws carry legal force in theUK and in recent years the NHS has hadto implement and comply with legislationcoming from Brussels in areas as diverse asthe mobility of health professionals andpatients, working time, public pro-curement, waste management, energyefficiency and many more. By and largethese have been new challenges for theNHS; for managers, clinicians and policy-makers alike.
This is why the NHS European Office wasestablished in 2007 as a nationwideresource to monitor EU developments thatimpact on the NHS and to contributeNHS views and frontline expertise to EUdecision- makers. Its aim was to act as onefocal point through which EU institutionscould easily access views, advice andexpertise from the NHS.
A European Health Service? When the Office was established wasimportant. Recent European Court rulingshad shown that the debate had moved onfrom whether EU Internal Market rulesapplied to the NHS as to how they apply.For the first time the European Com-mission was planning legislation
specifically in the area of health careservices. This led to a proposal for an EUDirective on patients’ rights in cross-border health care in summer 2008, withpotentially far reaching implications forNHS organisations.
Some provisions in the original proposalgave rise to the potential for both con-fusion and conflict between the scope ofthe legislation and the national government’s responsibilities for theorganisation, management and funding ofhealth care. On entitlements, for example,whilst the principle of patients having theright to access in other EU Member Statesthe same health care that they are entitledto receive under the NHS sounded simple,the NHS does not have a defined list ofcare to which patients are automaticallyentitled. Likewise, a key differencebetween patient choice in England andcross-border health care is that domesti-cally patient choice is limited to providerscontracted to the NHS, rather than anyhealth care provider.1 The Directive oncross-border health care was finally agreedby both the European Parliament and theCouncil of Ministers in early 2011 aftermore than two years of difficult negotia-tions. Member States will now have untilmid 2013 to transpose it into national law.2
Whilst the Directive on the mobility ofpatients has only just been agreed, legis-lation on the mobility of professionals waspassed in 2005. The Directive on theMutual Recognition of Professional Qual-ifications was seen as a key tool in helping
to abolish obstacles to the free movementof workers across and within the EU, ofwhich health care professionals formed akey group.
Five years on, this issue has become highlycontroversial for our health service; withregulators and the UK Parliament’s HealthSelect Committee calling for enhanced lan-guage and competence checks forprofessionals coming from other EUMember States, as well as for a more sys-tematic exchange of information betweenregulators in EU countries on disciplinaryactions against professionals.
Beside internal market rules, the EU’slabour law has also had important implica-tions for the NHS. This includes, inparticular, the European Working TimeDirective, which has applied to the vastmajority of NHS employees since 1998,but whose provisions were phased-in grad-ually for doctors in training, with theirmaximum weekly average working hoursreduced eventually to 48 hours fromAugust 2009. Whilst the NHS had to adaptand adjust to these rules, this has not beenthe end of the matter. Subsequent casesbrought before the European Court ofJustice by a Spanish medical union and aGerman doctor led to rulings that on-calltime, when a doctor is obliged to be res-ident in a hospital or health centre, countsas working time and that compensatoryrest for missed rest must be taken immedi-ately after the end of the working period,rather than aggregated and taken at a latertime.
The NHS’ engagement with European affairs
Elisabetta Zanon
Summary: EU policy and legislation are having an increasing impact on NHS organ-isations, not only as providers and commissioners of health care, but also as employersand as businesses. The NHS European Office was established in 2007 to engage withEU developments that impact on the NHS by contributing NHS views and frontlineexpertise to EU decision-makers. The article highlights some of the impacts of EUpolicy and legislation on the NHS, and sets out the role now being played by theNHS European Office.
Key words: NHS, European legislation, health policy
Elisabetta Zanon is Director of theNHS European Office, Brussels. Email: [email protected]
EU developments in many other policyareas such as environment and energy per-formance, innovation and research,commercial transactions or state subsidiesalso permeate to the heart of the NHS.
The role of the NHS European OfficeThe policy areas may differ but the role ofthe NHS European Office in respondingto EU developments is the same: to rep-resent the interest of the NHS. Whether aproposal is in the early planning stages,being voted on in the European Parliamentor about to be implemented into nationallaw, the Office has a role. By contributingviews and expertise at the earliest possibleopportunity, we can shape the direction ofa new or revised piece of legislation andensure that EU decision-makers are awareof the potential impact of EU proposals onfrontline services. Once legislation isagreed at European level, our role then isto assist NHS organisations to prepare forimplementation.
Of course, the applicability of EU law tothe NHS is not solely dependent on thepassing of new legislation in Brussels. TheNHS should be aware of the boundariesand reach of European law when it itself isorganising how it provides services to itspatients. This is particularly relevant inrelation to the EU’s powerful and complexset of competition rules, which governtrading market structures and behaviour inorder to uphold 'fair play' within the EU'sinternal market.
NHS activity has traditionally been con-sidered as fulfilling a social function, andtherefore not subject to the EU compe-tition rules. However, as the NHS furtherdevelops the way it delivers health care toincorporate patient choice and a wider rolefor independent health care providers, theextent to which it could be challengedunder these rules becomes less clear.
The NHS European Office reviewed pastEuropean Court rulings to understand thelegal framework and the range of potentialimplications for the NHS and providedbriefings and advice to NHS organisationsin this area.3 In light of the proposed pro-gramme of NHS reforms in England putforward by the UK Government recently,there is uncertainty about how EU compe-tition law will affect relationships withinand across the NHS in future years. Whatis certain, however, is that it is importantthat there is an informed NHS, aware ofwhat EU competition rules may mean forits many parts as they develop the waythey provide and structure their services.
Challenges, but also opportunitiesIn parallel to this work, we also provideinformation and advice to NHS managersand clinicians on opportunities emergingfrom different EU programmes and initia-tives. Particularly in the current economicclimate, NHS organisations should beaware of funding opportunities available atEU level but also be looking at opportu-nities to cooperate with our counterpartsacross Europe and learn from their experi-ences and good practice.
The benefits of participating in European-funded projects are wide ranging.4 Theycan complement local NHS initiatives withEuropean Commission matched funding;improve service delivery through infor-mation-sharing and the exchange of goodpractice with European partners;benchmark and compare NHS organisa-tional data with partners from other EUMember States; and showcase an organi-sation’s achievements in a specific field ortopic to international colleagues.
The NHS European Office is activelyinvolved in a number of European partnerorganisations, which facilitate collabo-ration between NHS representatives andtheir counterparts across the EU in dif-ferent areas. For example, the annualExchange Programme run by theEuropean Hospital and Healthcare Feder-ation, has allowed dozens of NHSmanagers to ‘experience’ and learn fromother health care systems in Europe.
Looking ahead, the NHS European Officewill continue to feed NHS expertise to EUdecision-makers, notably in view of theforthcoming revisions of EU Directives onworking time, professional qualifications,5
public procurement,6 clinical trials andmedical devices. We will also build on oursuccessful European partnerships and con-tinue to facilitate NHS participation in EUprojects and joint initiatives for the devel-
opment of responses to the common chal-lenges lying ahead of Europe’s health caresystems and organisations.
REFERENCES
1. NHS European Office. Healthcare inEurope. NHS Views on the European Commission's Proposals on Cross-BorderHealthcare. Brussels: NHS Confederation,2009. Available at www.nhsconfed.org/europe
2. European Parliament. Patients' Rights inCross-Border Healthcare. Strasbourg 19January 2011. Available at http://www.eu-roparl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2011-0007&language=EN&ring=A7-2010-0307#BKMD-2
3. NHS European Office. What Do EUCompetition Rules Mean for the NHS?Brussels: NHS Confederation, 2009. Available at www.nhsconfed.org/europe
4. NHS European Office. CollaborationBeyond Borders. European Funding Opportunities for the NHS. Brussels: NHS Confederation, 2010. Available atwww.nhsconfed.org/europe
5. NHS European Office. Mobility ofHealth Professionals. Your Views on theRecognition of Professional QualificationsDirective. Brussels: NHS Confederation,2011. Available at www.nhsemployers.org
6. NHS European Office. How to Buy,What to Buy. Revising the EU Public Procurement Rules. Brussels: NHS Confederation, 2011. Available atwww.nhsconfed.org/europe
The NHS European Office is part of theNHS Confederation and is funded by theStrategic Health Authorities in England.For more detailed information on thework of the Office, visitwww.nhsconfed.org/europe
Eurohealth Vol 16 No 4 4
EU LAW AND HEALTH
New HiT on United Kingdom/England
The Health System in Transition report on England is the most comprehensiveoverview of the health and social care system in England produced this century.It provides a wealth of detail about all aspects of the health care system, as wellas developments in the health of the population.
Drawing on a detailed analysis of the changes to health care introduced by a se-ries of Labour governments between 1997 and 2010, the report’s author SeánBoyle gives his assessment of the impact that these changes have had in termsof access, equity, efficiency, quality and health outcomes. This definitive reporton one of Europe’s largest and complex health care systems will be a valuableresource for policy analysts and health system researchers for years to come.
Available online in March 2011 at www.healthobservatory.eu
Eurohealth Vol 16 No 45
EU LAW AND HEALTH
There is an increasing interest in theimpacts of European Union (EU) law onthe health care sector. Focusing on institu-tional matters in this respect, this articlewill consider three questions: What isspecial about EU law? What challengesand opportunities for those in the healthcare sector therefore arise? What kinds ofquestions should those involved in man-aging the health care sector therefore beasking themselves?
To understand the answers to these ques-tions, we need to understand the limitedcompetence of the EU in the field of healthcare; EU law making processes (both leg-islative and judicial); the structure of EUlaw, and in particular the centrality of‘internal market’ law; and the concepts ofsupremacy and ‘direct effect’ or individualenforceability of EU law. We also need toconsider the policy responses that the EUhas adopted, and may adopt, to ‘add value’to health care systems using EU institu-tions and processes.
EU law making and the competence ofthe EUThe EU is not a state. Its institutions maynot make any law or adopt any policy they
wish. They may only act within the powersgiven to the EU by its Member States.1
This is the idea of limited competences. Itis an important feature of EU law andpolicy-making, for it both constrains theEU and also means that the EU sometimesuses its powers for unexpected purposes.For instance, who would have thought thatthe power to create a single market withinthe EU (an area where goods and servicesmove freely) would give the power toadopt a Directive (an EU law) that forbidsthe advertising of tobacco on television;2
or EU law that covers the social securityentitlements of people who work inanother EU country;3 or a Directive thatforbids direct to consumer advertising ofprescription-only pharmaceuticals?4
If the EU has a law-making power, the waythat it can exercise that power is through alaw-making process that involves three keyinstitutions. The European Commissionmakes the original proposal. The EuropeanParliament and the Council must thenagree to it. But the European Commissiondoes not have a specific ‘health care min-istry’, and often the national ministers inCouncil that are present or involved inadopting a piece of EU law with effects forthe health care sector are not ministers ofhealth. The EU law-making process cantherefore inadvertently fail to considerimportant ramifications for health caresystems.
The structure of EU lawThe way that EU law has developed is aproduct of the history of the EU. Histori-cally, the raison d’etre of the EU was tobring together the economies of theMember States (the countries that are partof the EU) – especially their coal and steelindustries, which were the engines ofwarfare – in such a way as to prevent futurewars in Europe. Integrated economieswould mean that war was a practicalimpossibility. Also, the idea was to capi-talise on the economies of scale that areassociated with having large markets forgoods and services.
Because of its history, EU law is structuredaround the key ideas of free movement andfair competition within a single Europeanmarket. The law plays a crucial role in theprocess of integrating Europe’s economies.EU free movement law and EU compe-tition law form the bedrock of EU law.
EU free movement law applies essentiallyto the acts of ‘states’ or public authorities.It prohibits ‘restrictions’ on the freemovement of goods and services within theEU’s internal market. It also includespublic procurement law, to make sure thatpublic contracts can be won by providersfrom anywhere in the EU, not simplygiven to local firms. Most EU public pro-curement law does not apply to the healthcare sector, but some of it does. EU freemovement law does not simply contain
The impacts of European Unionlaw on the health care sector: Institutional overview
Tamara Hervey
Summary: The logic and structures of European Union (EU) law are not the logicand structures of health care. The institutional structures that support law and policy-making at EU level are often unsupportive of (or even unaware of) health care concerns. The special nature of EU law means it has much more significance in practice for national actors than ‘ordinary’ international law. Sometimes, that significance can have – or threaten to have – challenging effects for national healthcare systems. Nevertheless, the EU also offers potential benefits to health care actorsacross the Member States.
Keywords: health care, law, European Union
Tamara Hervey is Jean Monnet Professorof European Union Law, School of Law,University of Sheffield, UK. Email: [email protected]
unfettered rights to free movement – somerestrictions are justified, for ‘objectivepublic interests’, such as protecting con-sumers; or ensuring sufficient andpermanent access to a balanced range ofhigh quality hospital services in theMember State; or maintaining the financialviability of a health care system.5,6
So those within the health care sector needto ask questions about whether theirpolicies or practices restrict free movementin the internal market, and if so, whetherthey comply with EU law.
EU competition law applies essentially toprivate actors – to ‘undertakings’ or firmsoperating within the EU. Most EU com-petition law therefore does not apply to thepublic health care sector. But there areexceptional cases where it does – if a partof the health care sector is acting as an‘undertaking’, i.e., if it is engaged in an eco-nomic activity.7 Again, exceptions to EUcompetition law apply to public bodies, ifthey need to have a special monopolistposition in the market, in order to providea public service of special interest, such ashealth care.
So those within the health care sector needto ask questions about whether they areacting as an undertaking, and if so, if theyare complying with EU law.
In addition to free movement and fair com-petition, even from the beginning, the EUhad the power to adopt law and policy tosoften or make fairer the impacts of cre-ating a single market. For instance, to makesure that workers did not lose out in theprocess, EU law covers health and safetyin the workplace. To make sure that con-sumers are not harmed by products orservices circulating in the internal market,EU law sets safety and consumer pro-tection standards. To make the internalmarket run smoothly, EU law governscommercial contracts. For instance, thesystem of medicines authorisation inEurope is a product of EU law. To makesure that the single market does notadversely affect the environment, a largebody of EU environmental law coversmatters such as air and water quality andthe disposal of waste. To protect patients,EU law covers blood safety and regulatesthe use of human tissue and organs.8
Those within the health care sectortherefore need to be aware of a wide rangeof substantive rules of EU law that applyto them as employers, as contractors, asproducers of waste, as providers of servicesand so on. Specific details vary, so of course
specific advice should always be sought.
The supremacy of EU lawUnlike ordinary international law, EU lawhas a special legal status in the legal systemsof its Member States. This legal status wasnot explicitly agreed by the Member States,but has been ‘created’ by the EuropeanCourt of Justice (ECJ). However, it hasbeen accepted by national courts. This isthe idea of supremacy of EU law – it meansthat EU law applies over any contradictorynational law, and national law that contra-dicts EU law must be ‘disapplied’.9 Theconsequence of supremacy of EU law isthat national parliaments cannot legislatetheir way out of EU law that they do notsupport. Nor can, for instance, self-regu-lating professional associations do so. Theymust comply with EU law.
The consequence of non-compliance for astate is first political censure and (even-tually) being brought before the ECJ. Butfor public bodies within states, a muchmore important dynamic is at work. Thisis known as the ‘direct effect’, or enforce-ability of EU law.
The enforceability of EU lawNot only is EU law supreme, but it alsohas another very important feature – it isenforceable by individuals before theirnational courts. Not all of EU law isenforceable in this way, and not all of it isenforceable in this way against privateindividuals. But it is enforceable againststate bodies, which would include a widerange of public health care institutionswithin the Member States.10
The consequence of the ‘direct effect’ ofEU law is that a private individual mayenforce a right in EU law against their ownstate, or any part of it, or public bodywithin it, such as national health carebodies. This enforcement happens withinnational courts.
This is the basis on which the by nowinfamous patient mobility cases werebrought to court.5,6,11 Various patients,unhappy with the level of provision intheir national health care systems forvarious reasons – too long a wait; not thetreatment that they hoped to get; cheapertreatment available abroad – brought casesin their own national courts, challengingtheir health authorities’ refusal to authorisethem to receive treatment abroad. In someof these cases, the ECJ (which is asked bynational courts for its interpretation of EUlaw in such cases) found that there was anunjustified restriction on free movement,
and so a breach of EU law. The best-known of these cases in the UK is theWatts case.12 The UK has now changed itspractice, to comply with EU law on thispoint, and guidelines for local health com-missioners are available. Other casesinclude a recent decision involvingrestricted access to university medicaltraining, which was challenged on the basisthat it breached EU law allowing citizensof EU states to move freely, including forthe purposes of education.13
What may turn out to be more significantthan individual human beings (patients)relying on EU law in the health care sectoris the use of EU law by firms, particularlylarger firms, operating in the health caresector, that seek to challenge nationalpolicies that impede their marketing oroperational strategies. So, for instance,Spanish law on the licensing of pharmacies,which limited the number of pharmaciesby population density, has recently beenchallenged (with partial success) asbreaching EU law on freedom of estab-lishment.14
All of this means that people working in asector such as the health care sector, whichis not structured according to market logic,have to be vigilant in terms of where EUlaw – which nevertheless has binding forcewithin the Member States of the EU –might interface with their activities.
Policy responsesThe EU not only adopts laws to achieve itsaims. It also makes use of a wide range ofpolicy instruments. These include EUfunding for research. EU research fundingis organised into ‘Framework Pro-grammes’ and gives opportunities toconduct collaborative research acrossborders. Many research projects – forinstance, on rare diseases – have been sup-ported by the EU. ‘European ReferenceNetworks’ – groups of health care expertsin a particular field – work together, sup-ported by the EU, to share knowledge andexpertise in state of the art medicalpractice. The idea is that the EU can ‘addvalue’ to activities that would not be soeffective if carried out at national levelalone. The EU’s public health programmesalso provide opportunities for funding forcollaborative work in the health field.
There is also the opportunity to feed intothe development of ‘best practice’ at EUlevel. The EU gathers and compares a widerange of health data that can be used toinform decision-making processes at alllevels. From this, we can begin to discern
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best practice. So, for example, the Councilhas adopted a recommendation on patientsafety, including health care associatedinfections. For example, the EU has beeninstrumental in developing the ‘EuropeanCode Against Cancer’, a collection of rec-ommended protocols on cancer screening,as well as best practices for the preventionand treatment of all cancers .15,16
ConclusionsIn one sense, there is no EU health care lawor policy – there is a patchwork of dif-ferent laws and policies that apply in thehealth care sector. It is very difficult tomake sense of the patchwork through thelens of health care.17
European public health care systems arebased on the sharing of resources withthose in need through taxation and redis-tribution organised by the state for thosewithin that state – a model of solidarity.Health systems are organised on a nationalbasis, and the benefits for those within eachsystem are achieved, in part, by exclusionof those outside the nation state concerned.By contrast, the EU’s internal market lawis concerned with abolishing national bar-riers to the movement of the factors ofproduction. The benefits of internalmarket law include access to a widermarket, with consequent efficiencies andeconomies of scale, that are implied inremoving national laws, administrativepractices and other barriers to cross-bordertrade. In other words, the logic of publichealth systems is based on protectionthrough exclusion and closure; the logic ofinternal market law is based on the benefitsof inclusion and openness.
This ‘clash of logic’ explains why the appli-cation of EU law within the health caresector is so problematic and challenging.However, harnessing the benefits of collab-orating and cooperating at EU level alsopresents an opportunity for those involvedin the health care sector.
REFERENCES
1. Article 5 Treaty on European Union.
2. Directive 89/552/EEC of 3 October 1989of the European Parliament and of theCouncil on the coordination of certain provisions laid down by law, regulation oradministrative action in Member Statesconcerning the provision of audiovisualmedia services (Audiovisual Media ServicesDirective), as amended in December 2007,OJ 2007 L 332/27.
3. Regulation 883/2004/EC of the
European Parliament and of the Council of29 April 2004 on the coordination of socialsecurity systems OJ 2004 L 166/1.
4. Directive 2001/83/EC of the EuropeanParliament and of the Council of 6 Novem-ber 2001 on the Community code relatingto medicinal products for human use OJ2001 L 311/67, Article 88, as amended. SeeCase C-316/09 MSD Sharpe and Dohme,pending case.
5. Mossialos E, Permanand G, Baeten R,Hervey T (eds). Health Systems Gover-nance in Europe: The Role of EU Law andPolicy. Cambridge: Cambridge UniversityPress, 2010.
6. Hervey T. If only it were so simple: public health services and EU law. In: Cremona M (ed). Public Services and EULaw. Oxford: Oxford University Press,2011.
7. Bettercare Ltd v Director of Fair Trading[2002] CAT 7; Case C-205/03-P FENIN[2006] ECR I-6295.
8. Farrell A-M. Adding value? EU governance of organ donation and trans-plantation. European Journal of HealthPolicy 2010;17:51–79.
9. Case 26/62 Van Gend en Loos [1963]ECR 1; Case 6/64 Costa v ENEL [1964]ECR 585.
10. Case 152/84 Marshall v Southampton
and South West Hampshire Area HealthAuthority [1986] ECR 723.
11. Beginning with Case C-158/96 Kohll[1998] ECR I-1931.
12. Case C-372/04 Watts [2006] ECR I-4325.
13. Case C-73/08 Bressol judgment of 13April 2010, nyr in ECR.
14. Cases C-570 & 571/07 Pérez andGomez judgment of 1 June 2010, nyr inECR.
15. Trubek L, Nance M, Hervey T. TheConstruction of a Healthier Europe: Lessons from the Fight Against Cancer.Wisconsin International Law Journal2008;26:804–43.
16. Trubek L, Oliver T, Liang C-M,Mokrohisky M, Campbell T. How regulatory frameworks fight cancer: twoexamples from the United States and theEuropean Union. Journal of Health CareLaw and Policy 2010;14. At:http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1665187.
17. Hervey T, Vanhercke B. Health careand the EU: the law and policy patchwork.In: Mossialos E, Permanand G, Baeten R,Hervey T. (eds.) Health Systems Gover-nance in Europe: The Role of EU Law andPolicy. Cambridge: Cambridge UniversityPress, 2010:84–133.
Eurohealth Vol 16 No 47
EU LAW AND HEALTH
There is a fundamental contradiction at the core of healthpolicy in the EU that makes it difficult to draw a line betweenEU and Member State responsibilities. This raises a number of difficult questions for policy makers and practitioners asthey struggle to interpret both 'hard' and 'soft' laws at EU andMember State level and to reconcile tensions between economic and social imperatives in health care.
The book addresses these complex questions by combininganalysis of the underlying issues with carefully chosen casestudies that illustrate how broader principles are played outin practice. Each chapter addresses a topical area in whichthere is considerable debate and potential uncertainty. Thebook thus offers a comprehensive discussion of a number ofcurrent and emerging governance issues in EU health policy,including regulatory, legal, 'new governance' and policy-making dynamics, and the application of the legal frameworkin these areas.
Health systems governance in Europe: the role of European law and policy
Edited by Elias Mossialos, Govin Permanand,Rita Baeten, Tamara Hervey
http://www.cambridge.org/gb/knowledge/isbn/item2713652/?site_locale=en_GB
Cambridge: CambridgeUniversity Press, 2010
Paperback 784 pages
ISBN: 9780521747561
£29.99
Medical devices and health technology perse are often quoted – along with pharma-ceuticals – as the key drivers of growinghealth care budgets. Health technologyassessment (HTA) seems a natural tool forharnessing medical technology in this role.The medtech industry, almost by default,accepts its role for keeping rising healthcare costs at bay by playing along withnational and international schemes,projects and institutions, which are pro-moting the concept of HTA. But does allof this really make sense in pinpointingwhere money is being spent effectively totreat patients efficiently? Or are there basicflaws in our ability to measure real value?
In reality, once health care is viewed as thebroad, complex and adaptive system that itis, a great many reasons can be identified –some completely unrelated to health tech-nology – to explain why health carebudgets are rising. So why should industryhave to continue accepting its role in theHTA schemes, ultimately playingscapegoat for an ever growing global healthexpenditure? Surely, it is time to challengethe effectiveness and logic behind thewhole HTA concept as it generallyoperates in countries across Europe, andindeed the world?
A glimpse of history and the questions ofpurpose The phenomenon of HTA, in its essentialsense of evaluating one intervention againstanother, can be traced as far back in historyas the mid-18th century. Literature datingfrom that time reported that a James Lind,from an Edinburgh medical school, con-ducted a controlled trial of six differenttreatments of scurvy. One example ofHTA from the following century comesfrom Pierre Louis in Paris, who, in 1830, proved that patients suffering from pneumonia received no benefit from phlebotomy.
For a more contemporary view, namely the1980s and 1990s, the ‘call for HTA’ can beattributed to the following:
– concerns about the adoption – and sus-tained use – of unproven technologies;
– rising costs; and
– the rise in consumer expectations.
After a few decades of HTA, there seemsbut little evidence of the practice helpingto stagnate - let alone decrease – overallcosts of health care. On the contrary,health care expenditure continues to rise ata pace roughly two percentage points overthe respective GDP growth of a country.
So what is going wrong? Are we using HTA like a panacea, ratherthan digging deeper into the issue thatreally needs addressing – namely making
health care truly efficient? And why are wefailing in this respect? It is because in eachand every country, there is a politicalagenda attached to health care and a fear ofmaking unpopular cuts. So the funda-mental question remains: can HTA reallybring about what it promises – moreeffective allocation of money in healthcare?
To answer this, it is worth broadening theargument to look at health technology inthe context of health care interventionsoverall.
A question of scope HTA in the general sense of the wordcovers much more than just technology.When we talk of HTA the first reason formisunderstanding lies in the discrepancybetween the term and its scope. Contraryto common practice, to ascertain a realpicture of where the most effective or leasteffective procedures lie, the word ‘inter-vention’ should be used instead of‘technology’.
The scope of what is called HTA shouldinclude all pharmaceuticals, vaccines,medical devices and diagnostics, medicaland surgical procedures, decisions andinterventions used to prevent disease andmaintain and restore health. If the tech-nology has to prove its case, why not everyother intervention?
If we are to consider evidence-baseddecision making in health care, we should
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Debate: Is HTA going to save health care budgetsor are its premises inherently flawed?
Miro Palat
Summary: Does the very nature of health technology assessment point the finger ofblame for soaring medical costs at the health care industry? Is it time to challenge thescope of HTA and call for comparative studies of all health care interventions so thatthe real value of medical technology is more accurately understood in the overallhealth care framework? These questions are the basis of this open debate article.
Key words: health technology assessment, medical devices, value, Czech Republic
Miro Palat is President of CzechMed, the Czech medical device industry association, Prague, Czech Republic. Email: [email protected]
be looking at evaluating all practices, anyintervention, not only those related totechnology. More often than not, the termHealth ‘Technology’ Assessment implies,that it is health technology in particularthat causes health care costs to rise andtherefore requires particular attention andevaluation. In other words, is the messagebeing delivered saying that HTA ulti-mately aims to curb health care costs byputting a finger on the perceived driver ofall the financial misery – health tech-nology?
Based on data from the EUCOMED, abody representing 4,500 designers, manu-facturers and suppliers of medicaltechnology used in the diagnosis, pre-vention, treatment and amelioration ofdisease and disability, the average pro-portion of health technology over totalhealth care spending in the ‘EU15 +Switzerland’ countries has risen between2004 and 2008 from 4.98% to 5.84%. Thatrepresents a growth of less than one per-centage point. At the same time the averageper capita health care spending in the samegroup of countries has risen by 39.25%.
With all respect to market spread and pen-
etration of health technology, it is morethan doubtful that health technology doesplay a significant role in this overallincrease in health care spending. So whatare the more likely drivers of the highincreases in health care costs? Is there pos-sibly a role for health technology tocontain costs that may not be seen clearlyfrom the outset? Here are some sugges-tions.
The first is that there is the ever broadeningscope of conditions that are treated or fol-lowed-up nowadays. Long ago theseconditions had passed the boundaries ofactual, perceptible disease and expanded inthe realm of abnormality. Let’s not get intoa misunderstanding here. There is a naturaland commendable tendency to researchand to understand the cause of diseases,their natural course and factors leading tothem and to adopt a preventative approach.Yet, such an approach leaves scores ofpeople, who appear otherwise healthy, toundergo numerous check-ups, interven-tions etc, often for the rest of their lives andat times doing more harm than good. Evenfor certain cancer screening programmes,when looking for hard evidence of out-
comes, like reducing mortality rates, theydo not hold as much as they promise.
In such cases, the absence of market mech-anisms leads to a situation where there is arisk of spending with unproven benefitover a long term. In other words, once ahealth care facility is "under contract", thatmeans its services are covered by healthinsurance or sickness fund schemes and itis rarely seen that such facility is closeddown due to low quality or reduced need.Indeed, more services are being openedthan closed.
Another approach which carries of risks ofineffective spending is the concept of enti-tlement to service. The original idea of auniversal health insurance system was tosecure access to care for all; but morerecently, during the 20th century – at leastin Europe – the population’s perceptionhas moved to a notion of entitlement tohealth service – almost like a state pensionor other types of benefits. We all perceivewe have a right to care and treatment whenwe want and need it. And to challenge suchan attitude in the political arena is not ameans for gaining popularity, and thereforegiven a wide berth.
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Figure 1: Regaining perspective – technology and the other health care expenses, 2008
0
1,000
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any
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ay
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Expenditure on medical technology Total health expenditure per capita
Expenditure on medical technology (as percentage of total health expenditure)
Total health expenditure per capita (Euro 000s)
Italy
* Source: Eucomed
Budgets creating demand, not technology driving budgets? Another cause of soaring health care costsis the fragmentation of health services, theabsence of coordination of care, and theduplication of procedures. In some aspects,waste is also generated when services failto provide minimum quality requirements.If medical technology plays a role in anyof the above factors that push up healthcare costs, it may do so in the everincreasing spread of supply of diagnosticand therapeutic procedures. However, howmuch influence the medtech industry andthe medical profession (or health careproviders in the broader sense) have oninflating the volume of procedures carriedout remains largely a chicken-or-eggquestion.
Is it the industry luring health care profes-sionals into an ever larger supply ofprocedures, for all of which eventuallythere will be patients recruited and thecosts paid? Or is it the medical professiontrying to dig ever deeper into the roots ofdisease, inventing newer and finer methodsthat the industry can deliver in a profitableway?
In any case both – industry and medicalprofessionals – are driven by the funda-mental incentive of doing business andmaking acceptable profit from monies thatare just sitting there waiting to be spent onhealth care. But contrary to the widespreadbelief that health technology is one of thefew key drivers of health care expenditure,there are deeper reasons behind soaringhealth care budgets.
The underlying question of health carefinancing is not whether this or that tech-nology is marginally/significantly more(cost-) effective. The underlying questionis: do we need this much care as providedtoday?
If we delve further into this question, wewould go beyond the scope of this article.But briefly considering this fundamentalquestion, surely, there is no linear corre-lation between ‘more medicine’ and ‘betteroutcomes’ - neither from the point of thepatient, who is largely kept in ignoranceover this, nor from the point of the healthcare payers – who in contrast to patientsare already very vocal.
Medtech wish-list for HTA The industry wants to avoid being drawninto the HTA game of apologetics, wheremedtech needs to prove its ‘right for life’over and over again. However, HTA
cannot be stopped and the medtechindustry can hardly bypass the hurdles setout in the various forms of HTA. But giventhe perceived shortfalls in HTA, as estab-lished in this article, how would industrypropose that HTA policies be modified inorder to truly evaluate the comparativecosts of health care technology againstother health care practices and decisions?
What should be evaluated? For the sake of fairness, the terminologyshould be changed. Instead of Health‘Technology’ Assessment, we should betalking of Health ‘Intervention’Assessment (HIA). The point being thatplentiful interventions remain in placewithout having ever been proven to work.Indeed, a quick search on the internet ofthe phrase "no proven benefits", showsscores of threads to follow. If medical tech-nology is put under the scrutiny, is it notpertinent for other interventions to followsuit?
What should be measured? There are basically two dimensions thatshould be evaluated: whether "it" works;and how much "it" should cost? Let usstick to efficacy for now. For the individualperson, the case seems to be very straight-forward in favour of a novel technology.For example, a circular CT is more sen-sitive and therefore superior in detectingearly stage lung cancer than the commonchest X-ray. However, opening thisargument out to the population can resultin a different efficacy ration. For instance,from the point of a population, routinelyscreening smokers and former smokerswith circular CT for early stage lung cancerto prevent death is equivocal. Researchsuggests that by routinely applying thistechnique with consequent surgicalremoval of the tumours, long term survivalrates have not improved. One explanationis that there are certain tumours that wouldnot have killed the carriers if left alone,whilst the truly dangerous cancers mightstill get missed. So the setting – the indi-vidual versus the population – can be ofdecisive difference in respect to thequestion: does ‘it’ work or not?
The same consideration then flows into the
financial aspect. If ‘it’ works, how muchdoes it cost to achieve the effect? Here theindustry calls for a level playing field. If aninnovative technology is evaluated, soshould the long established alternatives. Ifa technological procedure ‘candidate’ ischecked for cost per QALY (quality-adjusted life year) or cost per life saved etc,so should be the other treatment options aswell. Many of these are widely accepted,and perhaps were never evaluated in sucha manner, having mostly have entered thearena long before health care costs wassuch a pressing issue.
Once the evaluation is done, whatshould the outcome be? There should be clear a consequence ofHTA (or to use a better term, HIA) evalu-ation. A decision: to use or not to use; tofund or not to fund; under what condi-tions? The last thing the industry islooking for is yet another hurdle in theform of a HTA evaluation without theprospect of obtaining reimbursement foran innovative technology. Better still, HTAshould be used to weed out well estab-lished procedures of doubtful efficacy andvalue.
Even though the will for the latter has beenexpressed in personal communication bystakeholders and academics working onHTA, putting this into reality is still a bitfurther down the road.
In conclusion, the medtech industry isright to watch the whole notion of HTAwith a degree of suspicion. There may begood reasons for industry to fear it is beingdrawn into the position of the sole (alongwith pharma) agent responsible for ever-rising health care costs. By accepting theHTA game without challenge, the industry– by default – accepts this role and can donothing but remain apologetic: "yes, weare expensive, but at least we can prove ourproducts work and are worth the money".
Now, however, with all the medicalprogress that has come with innovativemedtech products, the industry can bebolder about the value its products anddemand a level playing field with otherinterventions in health care. It is time forindustry to be vocal too.
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This article was originally published on 2 November 2010 in Clinica Medtech Intelligenceand is available online at www.clinica.co.uk
Do you have a view on this article? If you are interested in writing a response for afuture article in Eurohealth please contact Sherry Merkur [email protected] todiscuss further
Eurohealth Vol 16 No 411
HEALTH TECHNOLOGY ASSESSMENT
Health care system organisation Historically, social insurance has playedthe predominant role in the organisationand financing of health care services inGreece. However, the system has beencharacterised by a lack of infrastructure,inadequate funding and great inequalitiesin access to and provision of services.1,2 Inthe early 1980s a National Health Service(NHS) was introduced to provide free,universal, equitable and comprehensivehealth coverage. Ever since, much efforthas been devoted towards makingimprovements in the human, technologicaland capital infrastructure of the system.
Recently there have been significant effortsto improve management and organisation,in order to increase efficiency, effectivenessand service quality. The reforms have notbeen that successful. Complexity, disor-ganisation, deficiencies and publicdissatisfaction have led to significantgrowth in private health care, particularlyin secondary and primary care settings.
Today, the Greek health care system is inessence characterised by the coexistence ofthree sub-systems, all of which are in tran-sition, especially after the recent financialcrisis and rapid reforms initiated as part ofthe obligations agreed in a memorandumsigned with the Troika (European Union,European Central Bank and InternationalMonetary Fund) within the context of therescue package agreed in May 2010.
Health care provision structures Secondary care encompasses 132 hospitalsin the NHS with 36,621 beds. There are
also fourteen military hospitals, two uni-versity hospitals, two prison, five SocialSecurity and six special status hospitalswith a total of 4,000 beds. The publicsector accounts for three quarters ofcapacity. The private sector includes 218hospitals with a capacity of 15,082 beds.
The NHS provides primary care through202 primary care health centres, 1,458 ruralmedical surgeries and 114 outpatient hos-pital departments. There are also aroundthirty Social Security Funds covering dif-ferent occupational groups, supervised bythe Ministry of Labour and Social Affairs.The most significant funds, which coverthe majority of the population, include theSocial Insurance Fund (IKA), the SocialInsurance Fund for Farmers (OGA), theFund for Merchants, Manufacturers andRelated Occupations (OAEE) and theFund for Civil Servants (OPAD). Theseentities provide primary care servicesthrough their own facilities and contractedphysicians. IKA, in particular, is a decen-tralised network of more than 300 healthcentres, polyclinics and large laboratories.It employs 8,320 general and specialistphysicians, as well as 3,934 nurses andother employees.
Apart from access to the NHS, the OGA,OAEE, OPAD and the remaining SicknessFunds offer primary care access to theirmembers through contracts with privatephysicians, laboratories and diagnosticcentres. There also some primary careservices within local authority structures.Primary care services are also provided by25,000 private physicians, practices and lab-
oratories and in 400 private diagnosticcentres and the outpatient departments ofprivate hospitals. This sector has seen sig-nificant growth in recent decades, mainlydue to public dissatisfaction with access andquality of care in the public system, as wellas an oversupply of medical doctors.3,4
Emergency care is provided both withinNHS and the private hospital sector. It issupported by a public national ambulanceservice network. Finally it should be noted,that despite continued efforts and invest-ment, shortages remain in the areas ofrehabilitation, long term, palliative andmental health care.
Health care expenditure and financing Total health care expenditure reached 9.6%of GDP in 2007, slightly above the averagefor Organisation for Economic Co-oper-ation and Development (OECD) countries.Private expenditure accounts for 39.7% oftotal expenditure. Public expenditure fromtaxation and social security paymentsaccount for 29.1% and 31.2% of totalexpenditure respectively. This reliance onprivate care is a characteristic which differ-entiates the Greek from many otherEuropean health care systems.2 Publicexpenditure for primary care is 22.9%, forhospital care 55.9%, for dental care 1.2%and for pharmaceutical care 15.8%, whilstthe corresponding figures for privateexpenditure are 31.4%, 12.4%, 34% and15.4% respectively.
NHS staff salaries are financed directlythrough the state budget. Other operatingexpenses are financed through servicecharges to Social Security Funds andpatient charges. Charges are defined eitheron a per diem, per case or per service basisand are made retrospectively. It is notablethat they have not been updated for a longtime. This contributes to the generation of
Developing HTA frameworks inemerging markets: the road ahead
The case of Greece
John Relakis and Nikos Maniadakis
John Relakis is Doctoral Researcher – Research Fellow and Nikos Maniadakis is Professorand Department Director, Health Services Organisation and Management, NationalSchool of Public Health, Greece. Email: [email protected]
significant hospital deficits which have tobe covered by the state budget. In addition,public sickness funds finance the healthcare services they provide directly to theircovered population. Doctors employeddirectly or via contract are paid either on acapitation or fee-for-service basis and thefunds also cover drug and examination pre-scriptions. The private sector is financedthrough charges to sickness funds, privateinsurers and patients.
Comparisons with other OECD countriesOverall, the number of acute care hospitalbeds is 3.9 per 1,000 inhabitants, similar tothe OECD average. However, there aremore physicians per capita than in anyother OECD country. In recent decades,the number of practising doctors hasincreased rapidly to 5.4 per 1,000 popu-lation, with the corresponding figures forspecialists being 3.4, dentists 1.3 and phar-macists 0.9. Thus the country is at the topof the OECD list for the employment ofthese professionals.2 Yet, there are only 3.2practising nurses per 1,000 population and0.31 practising general practitioners (GPs),much lower than the OECD average.These peculiarities create distortions in theefficient organisation and delivery ofhealth care.
During the past decade, there has also beenrapid growth in the availability and use ofdiagnostic and interventional technologies,especially in the private sector. The numberof CT scanners reached 25.8 per millioninhabitants in 2007, above the OECDaverage of 22.8. The number of magneticresonance imagers (MRI) is also relativelyhigh: 13.2 MRIs per million inhabitantscompared to an OECD average of 11.8.There were 36.5 and 19.9 mammographymachines per million inhabitants in Greeceand across the OECD respectively. It isnotable that due to strong supplier-induceddemand, in combination with an absenceof control and guidelines, Greece has thehighest per capita number of examinationswith these technologies in the OECD.Pharmaceuticals account for more than 2%of GDP, ranking Greece at the top ofOECD countries, as a result of highvolume and expensive drug mix con-sumption.1,2
Current health care reforms There is an enormous effort at present toreform the health care system under thesurveillance and guidance of the Troika.Hundreds of measures aim to contain costand increase service efficiency and quality.
An emphasis is given to the introductionof information technology and modernfinancial management mechanisms, e-pre-scription, the introduction of guidelineimplementation, the rationalisation of drugand medical device procurement and use,reduction in the costs of personnel, reor-ganisation of social security and health careservices, and to the re-definition of therelationship with the private sector. In thiscontext major social security and healthservice reform is unfolding. Most notablythe provision of health services is beingtaken away from the Sickness Funds andincorporated in the NHS. Additionally, theSickness Funds are being merged to asingle monopsonistic body vis a vis thepublic and private producers.
Impact on Implantable Medical Devices The past year has been a turning point forthe medical devices sector. Specifically, thissector had been growing fast in recentyears, with sales of €1.9 billion in 2009, a15% increase on 2008.5 It has been charac-terised by the presence of many localdistributors working on behalf of interna-tional manufacturers, who wish to avoidthe bureaucracy and late payments in thehealth care system. There was a highdependency on the public hospital sector,which generated 65% of the business.
In 2010 the sector experienced significantchanges. After many years of delays andunfulfilled promises, the public sector debtwas addressed partly through cash injec-tions but mainly through zero couponbonds, which imposed a further burden oncompanies. Moreover, because of thefinancial status of the country and itsbanking system, access to financingbecame expensive and difficult. Hencefirms had to cope with a challengingfinancial situation. Furthermore, hospitaladministrators negotiated prices down andthis, together with Sickness Fund mandatesand the introduction of a Price Obser-vatory, led to significant prices reductions,which in some cases amounted to 50%within the year.
The procurement of medical devices inpublic hospitals had mainly been throughcompetitive tenders. Successful biddershad to sign annual contracts obliging themto maintain normal delivery of services tohospitals. Devices and all other medicalmaterials used for interventions wereinvoiced in most cases on an individualpatient basis, at the time of actual use,raising administration costs for all parties.In respect of implantable pacemakers and
implantable cardiac defibrillators, for muchof the past decade special legislation settingmaximum procurement prices was in place.This system was criticised at a Europeanlevel because it distorted competition andhas now been abandoned.
In this context national tenders for servicesand technologies were issued by the newlyestablished National Procurement Com-mittee, for two-year framework agree-ments for public hospitals across the entirecountry. Initial tenders focussed oncoronary stents and cardiac rhythmdevices. Tender competition and conse-quently price erosion has been significant.These developments inevitably will lead togreater concentration of market share andto significant changes in its organisationand structure. Some traditional medicaldevice distributors have been replaced bythe device manufacturers. It is notable thatsome multinational manufacturing com-panies were successful in winning tenders,implying distributors will be out of themarket for some time.
Constant reforms to the public pro-curement processes mean that the systemremains very uncertain and complicated.These constant changes mean hospitals arestill procuring devices through direct nego-tiations with providers; these are notstrictly legal when the amount concernedexceeds €20,000. At the same time hos-pitals are trying to complete more than10,000 hospital level tenders initiated in2010. Simultaneously, the National Pro-curement Committee has published adozen significant tenders for the entirecountry. All these imply that there aremany systems running in parallel raisingcomplexity and costs.
Moreover, the Government passed legis-lation in March 2011 that will transformthe National Procurement Committee intoa Technical Specifications Committee.Tenders will be shifted to Regional HealthAuthorities to be implemented on aregional or national basis. A SupremeNational Council has been created at theMinistry of Health, comprising the Secre-taries of Health and the Heads of theRegional Health Authorities, to overseeand coordinate the operation of the NHSprocurement system and to delegatetenders to various authorities, includinghospitals. There is also a provision that theMinistry of Health has the right to out-source the entire tendering process,logistics and the provision of medicaldevices to a single entity that can be aprivate enterprise or a joint venture
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HEALTH TECHNOLOGY ASSESSMENT
between the public and the private sector.
In any case, regardless of which party willcomplete the tender (hospital, nationalcommittee, regional health authority,private entity), when the process is con-cluded public hospitals will still signagreements to buy devices on the basis ofneed. In some cases the costs of devices willbe covered by the treatment tariff chargedto the Sickness Funds. In other cases hos-pitals will still be charging the Funds atariff covering daily hospitalisation cost inaddition to the costs of devices used. Thisis, for instance, the case for pacemakers anddefibrillators. There can also be combina-tions of approaches. For instance, there isa prefixed tariff for coronary angioplastywhich covers all consumables, hospitalstay, the first stent and the first balloon.Additional stents or balloons will incuradditional charges.
The Ministry of Health is now consideringthe introduction of a Diagnosis RelatedGroup (DRG) type prospective reim-bursement system. In the meantimeSickness Funds and hospitals have recentlystarted to reimburse only those deviceswhose prices are in parity with those pub-lished by the National Medical DevicePrice Observatory of the ProcurementCommittee. The classification systems ofthe European Diagnostic ManufacturersAssociation (EDMA) and the GlobalMedical Device Nomenclature (GMDN)will be used to classify products in thedatabase of the Observatory.
It is notable that, depending on the type ofprocedure undertaken (implantation ofstent, pacemaker, percutaneous valve), it isoften not possible for hospitals to chargesickness funds for many of the servicesprovided, or they may be charged at levelswell below cost. This explains why publichospitals can still generate significantdeficits and why providers often get paidtwo or three years after invoice. Paymentcan only be made once a special subsidyfrom the Government and legal clearanceare received which delays matters further.As a result there is fragmentation, bureau-cracy, legal costs and discounts imposedupon debt settlement. To counter thisproviders charge public hospitals, who inturn charge social security funds, muchhigher prices than to other European coun-tries. Given recent price decreases,company margins will be squeezed iforganisational weaknesses in the NHSpersist in the short to medium term.
Looking at medical device use in the
private sector, the procurement sub-sidiaries of private hospitals often enterinto direct negotiations with manufac-turers or their local distributors. Theydemand, and usually obtain, prospective orretrospective price discounts and thusmake a profit on the device procured. Theycharge sickness funds the (undiscounted)cost of the device and they also get a fee forthe service either from the sickness fund,private insurer or the patient, depending onthe type of procedure. In some cases, thecost of the device is charged directly topatients, even if this is being covered ret-rospectively by their sickness funds. Thisraises administration costs and risks tomedical device providers. Moreover, asprivate hospitals are concentrated in a fewlarge firms, they also often exercise theirnegotiating power by delaying payingmedical device providers. Hence, there arealso significant hidden transaction costs inthe private hospital sector.
Finally, it is notable that due to the highprices of the past, some private and publichospitals have started to import products(e.g. stents) outside of the official distri-bution channel; this raises issues aroundeffective vigilance, quality and patientsafety. However, recent price reductionswill probably end this practice.
Health Technology Assessment and devices Health Technology Assessment (HTA) hasbeen termed ‘the bridge between evidenceand policy making’. HTA has for a longtime been extensively applied in manycountries for assessing pharmaceuticals,but devices are somewhat different andpose many challenges that stem from theirspecific nature and short life cycle.Nonetheless, despite these difficulties,HTA is increasingly used to improvedecision making regarding the utilisationand funding of medical devices acrossmany European countries. However, cur-rently Greece does not have any structureor formal process in place for assessingdevices, while there has been much dis-cussion about the need for assessingpharmaceuticals. Recent legislation ensuresthat pharmaceuticals will be assessed in thenew reimbursement system on the basis ofeffectiveness and cost effectiveness. Specif-ically, there will be a reference reimburse-ment price for drugs, based on the averageprice of the drugs in a specific cluster.Anyone seeking a premium on this pricewill have to provide solid evidence of economic and clinical benefits.
Devices, in contrast, are used as long theyhave a CE Mark; procurement and reim-bursement is currently based solely onlyon their price. Only in extremely rare casesmay other HTA criteria such as quality,innovation, safety, effectiveness and budgetimpact have been considered. In each hos-pital, or in other regional and nationalsettings, various committees comprised ofmembers from different backgrounds, setarbitrary procurement criteria and devicetechnical specifications. Various com-mittees also evaluate offers based solely ontechnical specifications and price. Thisprocess has generated a lot of inefficiency,bureaucracy, corruption and legal battlesand it distorts hospital operation.
The landscape for IMDs over the nextfive yearsGreece has now entered a new era wherefor many years there will be efforts toaddress inefficiencies and to reduce the sizeand the costs of the entire public sector.2010 was a tough year following the reve-lation that the country had a budget deficitin 2009 equivalent to about 15% of GDP.In May 2010 the country agreed a longterm rescue programme which includesmany austerity measures. The governmenthas looked to trim a few billion euros offthe budget deficit through tax increasesand cuts in many areas, including healthcare. This effort inevitably had a negativeimpact on expenditure for medical devicesin 2010; and it will certainly continue to doso for years to come.
There was a need not only for reform andmodernisation in the procurement,assessment and use of medical devices, butalso in the health care system as a whole.This need has been exacerbated by therecent financial crisis, which offers an envi-ronment and opportunities for tough, butnecessary changes and health care reform.Reimbursement prices for medical devicesare being forced down dramatically in aneffort to reduce expenditure. In the nextfew years, the prices of most devices willreduce further coming closer to theEuropean average. It remains to be seenwhether the prevailing conditions in thehealth care system will also converge toEuropean norms. At the same time thegovernment will make efforts to evaluateand monitor the volume of devices used,through the use of modern informationtechnology and guidelines. These trendswill in the short term shrink but also ratio-nalise the device market. They will lead toconsolidation and company closures. Inthe future most manufacturers may operate
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HEALTH TECHNOLOGY ASSESSMENT
Developing HTA frameworks inemerging markets: the roadahead
The case of Serbia
Predrag Djukic
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HEALTH TECHNOLOGY ASSESSMENT
An overview of the health care systemSerbia has a tradition of a publicly pro-vided health care system financed throughsocial health insurance. Public expenditureon health was approximately 6.3% ofGross Domestic Product (GDP) in 2008.1
Life expectancy at birth in the country in2008 was 73.65; 71.06 for men and 76.23years for women.2 There has been a longterm decline in rates of infant mortality,with the rate decreasing from 8.1 per 1,000live births in 2004 to 6.7 in 2008.
The Ministry of Health (MoH) and localmunicipalities provide finance for capitalinvestment in health service provision,while the Health Insurance Fund (HIF)covers recurrent expenditure throughinput-based provider payments. The HIFis financed through social insurance con-tributions, equivalent to 12.3% of grosssalary, equally shared by employers andemployees. About half of all HIF funds areused to support care in secondary and ter-tiary Health Care Institutions (HCIs).
The current national policy is to transferaccountability for the management of theprimary health care sector to local gov-ernment. Primary care is delivered through anetwork of primary health centres (Domzdravlja, DZ), whose structures vary slightlydepending on the size of the municipalitycovered. A DZ may incorporate a network ofhealth stations (ambulanta) in the munici-pality. They provide primary health care,limited specialist consultation services, publichealth services, tuberculosis control and some
other services. Public pharmacies associatedwith each DZ dispense prescriptions.
Hospital infrastructure is extensive andcomplex comprising a wide range of hos-pital types. In 2008 there were 107 inpatienthealth institutions in the country, (notincluding the 21 DZs that have inpatientbeds).2 Basic acute hospital care is providedthrough 40 general hospitals. There are also37 specialised hospitals, sixteen institutes,six clinics, four clinical-hospital centres andfour clinical centres. These institutionscomprise specialist inpatient facilities pro-viding tertiary care, institutions targetingspecial population groups (children,women), or institutions targeting patientssuffering from a particular type of disease,including tuberculosis, cerebral palsy andaddiction disorders.
In terms of bed numbers, the 107 facilitiesincluded 40,908 hospital beds, of which24,659 were in surgical, general medicineor paediatric wards and 8,775 in gynaeco-logical and psychiatric wards. Another6,222 beds were used for rehabilitation. Inaddition there were a further 346 beds inDZs providing primary health care.Overall this is equivalent to 5.6 beds per1,000 population.
In terms of the utilisation of hospitalservices, in 2007 the rate of hospitalisationwas 139.76 patients per 1,000 people, withan overall average length of stay (ALOS)of 9.2 days (including psychiatric care) andan overall average bed occupancy rate of74.7%, based on approximately 1,027,000
directly in the market rather than use dis-tributors, as margins will be much lower.
Nonetheless, in the medium and long termthe landscape may improve. There aremany initiatives underway to improveorganisation and financing of the healthcare system so as to make its dealings withproviders more efficient and less cum-bersome, risky and costly. Despite rapidgrowth over the past few years, implan-tation rates for most devices are still muchlower than in other European countries,leaving great opportunities to addressunmet need. Implantations of pacemakers,have reached 700 per million inhabitants(versus 1,200 in Germany), whileimplantable cardiac defibrillators reached90 per million (versus 260 in Germany).There were 1,800 percutaneous coronaryinterventions per million inhabitants com-pared to 3,660 per million in Germany.6
Despite a determination to introduce HTAin the assessment of drugs, it is veryunlikely that this will be the case formedical devices anytime soon, due to tech-nical limitations. However, as changes indemographics and technology put morepressure on health care and medical deviceexpenditure, there will be an everincreasing need to improve the system forevaluating, purchasing, using and reim-bursing devices. This will increase pressurefor the introduction of HTA in this area.The experience of other European coun-tries will be valuable in this respect, even ifthis takes some time to come.
REFERENCES
1. Economou C, Claude G. Improving thePerformance of the Public Health Care Sys-tem in Greece. Paris: OECD EconomicsDepartment, Working Paper No. 722, 2009.
2. Economou C. Greece: Health system re-view. Health Systems in Transition2010;12(7)1–180.
3. Siskou O, Kaitelidou D, Papakonstanti-nou V, Liaropoulos L. Private health ex-penditure in the Greek health care system:where truth ends and the myth begins.Health Policy 2008;88:282–93.
4. Tountas Y, Karnaki P, Pavi E, SouliotisK. The unexpected growth of the privatehealth sector in Greece. Health Policy2005;74(2):167–80.
5. ICAP Management Consultants. MarketAnalysis: Medical Products in Greece, 2009.
6. Eucomed web site. Available athttp://www.eucomed.org/
Predrag Djuki c is Consultant, Project Coordination Unit, Ministry of Health, Belgrade,Serbia. Email: [email protected]
This article reflects the views of the author and not the official opinion of the Ministry ofHealth in Serbia
total admissions. This level of hospital pro-vision is broadly comparable with that inother countries in central Europe.However, comparisons in ALOS per-formance with countries in westernEurope, for instance the UK (5 –6 days), areunfavourable. Bed levels in most countriesare now reducing significantly due todemographic change and the impact ofmodern forms of treatment that reducedependency on inpatient care. Thesefactors have not yet significantly influ-enced the hospital sector in Serbia.
Payment and performanceThe HIF is the single financing agentresponsible for paying health careproviders for the expenses incurred indelivering health care to the insured. His-torically HIF payments to providers hadbeen based on a fee-for-service approach,where a long list of services increased thecomplexity of reporting. During the lasttwo decades, while fee-for-service servedas a reporting and validation mechanism,line budget payments to institutionsbecame the de facto payment system. TheHIF pays providers according to line items(i.e., salaries for a set number of employees,costs of fuel, heat and lighting, medicinesand other medical supplies). It is thereforean input-based provider payment mech-anism, which controls overall public healthexpenditure, but does not provide anyincentives to contain costs at the level ofindividual HCI, improve efficiency andquality of care. Performance results inHCIs point to low productivity levels andidle resources. In addition, diagnosticinformation suggests that a significant pro-portion of hospital contacts could be dealtwith at the primary health care level. Whilecontracts between the HIF and HCIs dorequire HCIs to report performance, thereare no actions or penalties associated withpoor performance.
Serbia, like other countries, is moving fromretrospective to prospective paymentmethods to manage health care expen-diture. This will also help provideincentives for providers to contributetowards the overall health policy objectivesof improving efficiency and quality of care,financial sustainability for the health caresector, as well as equity in access to careand in population health status. It has beendetermined that the provider paymentsystem for primary care will be based oncapitation payments, while payments foracute secondary and tertiary care will bebased on a system of Diagnosis RelatedGroups.
It is also important to bear in mind that inSerbia there is a burgeoning but largelyunregulated private sector, focused mainlyon outpatient and ambulatory care andincluding private pharmacies. Privatehealth care still does not offer an effectivealternative to the public sector. In thefuture, the MoH envisages increasing theinvolvement of the private sector in thedelivery of publicly financed health careservices, underpinned by contracting,quality assurance and performance man-agement mechanisms.
Medical devicesThe Medicines and Medical DevicesAgency of Serbia is a governmental bodyresponsible for market authorisation ofmedical devices, while decisions on reim-bursement are made by the HIF in its roleas public payer. The process of obtainingmarket authorisation is clear with everystep described by the Agency.3
The HIF makes its reimbursement deci-sions taking into account a number offactors including its annual financial plan,the number of expected patients, efficiencyand effectiveness of the intervention/deviceand unit price, where this has a substantialbudgetary impact. Until recently, in anattempt to get lower unit prices and thuscontrol costs, the HIF organisednationwide tenders for high-priced medicaldevices (specifically in cardiology, cardio-vascular surgery and orthopaedics). Thismanaged to reduce prices considerably.Nowadays tendering responsibility is beingreturned to individual hospitals. This shiftin responsibility should remain in futuregiven changes in the provider paymentsystem, coupled with an increase in theautonomy and responsibility of hospitals.
Health Technology Assessment (HTA) isslowly gaining momentum in Serbia. Thereis a growing HTA department in the HIFwhose work supports reimbursement deci-sions. There is also an HTA Committee atthe MoH with very wide responsibilities,although probably not with enough tech-nical support. The reality is that althoughthe significance of HTA is increasing inSerbia, there remains a lot of room forfurther development and use in decision-making.
In recent years, the medical devices marketin Serbia has grown considerably. Oneillustration of this can be seen in thenumber of heart valve implantationsfinanced by the HIF. This grew from 973in 2005 to 1,350 in 2009.4 An even morestriking example can be seen with the use
of devices for invasive cardiology. Thenumber of implanted pacemakers grewfrom 350 in 2004 to 4,200 in 2009, whilethe number of implanted stents grew from1,900 in 2004 to 13,500 in 2009. The situ-ation is similar to that for other medicaldevices; growth can also be seen in thepharmaceutical sector.
What is the future for implantable medical devices?This rosy picture could be darkened by theimpact of the current economic crisis.Over the past decade, Serbia has begunrecuperating from the very difficult timeexperienced in the 1990s; however theglobal financial crisis may lead to aslowdown in economic growth that maywell be much greater than anticipated. Theprovision of health care services in Serbiais dependent on the size of the HIF budget,which is itself dependent on the rate ofemployment and level of salaries in thepopulation. This in turn will have animpact on funds available for medicaldevices. With growing unemployment,fewer people will be able to make contri-butions to the HIF, reducing the overallavailable budget. Another threat isinflation: a decline in the value of theSerbian Dinar would also impact adverselyof the HIF budget. A key questiontherefore, will be the way in which the eco-nomic crisis is handled. If Serbia managesto absorb the impact of the recent globalfinancial crisis and return to a path ofstrong economic growth, then the medicaldevices market will continue to follow thegrowth path seen in recent years.
REFERENCES
1. World Bank. Serbia: Doing More WithLess. Addressing the Fiscal Crisis by In-creasing Public Sector Productivity. Washington: World Bank, 2009. Availableat http://siteresources.worldbank.org/SERBIAEXTN/Resources/Serbia_PER_web.pdf
2. Institute of Public Health of Serbia.Zdravstveno-statisticki godišnjak RepublikeSrbije 2008 [Health Statistical Yearbook ofRepublic of Serbia 2008]. Belgrade: Insti-tute of Public Health of Serbia, 2009.
3. Medicines and Medical Devices Agencyof Serbia website (in Serbian) athttp://www.alims.gov.rs/index_eng.php
4. Ministry of Health and Health InsuranceFund of Serbia. Belgrade: Ministry ofHealth, 2010 website (in Serbian) athttp://www.rzzo.rs/index.php/ostavari-vanje-prava-stat-menu/kardio-stat-menu
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Eurohealth Vol 16 No 4 16
Poland has a mixed system of public andprivate financing of health care. The 1997Law on Universal Health Insurance estab-lished the framework for mandatory healthinsurance, including the universal healthinsurance contribution and budgetary con-tributions to expenditure by the statevoivodship*, county and communeauthorities. Mandatory health insurancecontributions are the major public sourceof health care financing; it is not possibleto opt out of the system. The NationalHealth Fund (NHF) has the responsibilityfor overall planning and the allocation ofresources in the Polish health care system.
The state budget plays a limited role in thepublicly funded health care system. Itcovers the costs of some public healthactivities, the health insurance contributionfor specific population groups, investmentsin public health care institutions, and reim-bursement of health services provided fora number of listed life-threatening situa-tions (called highly-qualified provisions).Private financing includes both formal andinformal sources of payments, as well asprepaid plans. There are public discussionsunderway on the development of a systemof alternative (private) or complementaryhealth insurance which could be offered tothe public.
This insurance-budgetary model of healthcare funding is regulated by the Law on theBasic Benefit Package (BBP). BBP regula-tions were set out by an Act of Parliamentin 2004 and respective GovernmentOrders. Important changes to these regu-lations were introduced in the second half
of 2009; because these changes are sorecent, the law contains a lot of imperfec-tions, divergence and ambiguity thatrequires constant improvement.
The BBP covers a number of areasincluding: basic health care, ambulatoryspecialist care, hospital treatment, psychi-atric care, long-term nursing care, dentalcare, medical devices (orthopaedic andmedical equipment) and prescription drugs.Each of the BBP provisions is welldescribed in the relevant GovernmentOrders, and these descriptions include thenames of procedures, as well as Interna-tional Classification of Disease codesVersion 9 (ICD-9) for procedures andICD-10 for disease indications. In somecases, there are detailed requirements forhealth care providers (for example, hos-pital/department conditions/equipment tobe used, number of doctors and their expe-rience, diagnostic tool availability etc).Government Orders are announced by theMinistry of Health on an annual basis, withthe first of these issued in September 2009.
These Government Orders are also thebasis for the NHF to set tariffs and enterinto contracts with health care providers.Only procedures listed in GovernmentOrders may be performed by health careproviders and reimbursed by the publicbudget. Indications (according to ICD-10)are also guidelines for NHF reim-bursement. The most recent GovernmentOrders were issued in October 2010/January 2011.
Pathway for reimbursementThe BBP Act also describes the reim-bursement pathway for procedures andtechnologies to be included in the BBP cat-alogue and also how the conditions or level
of reimbursement can be changed. In thisarticle, the focus is on procedures relatedto medical devices. In order to be includedin the BBP catalogue, a technology isassessed in terms of impact on: healthimprovement of the population; conse-quences of illness; clinical efficacy andsafety; risk of use; cost-effectiveness; andimpact on the health care system.
New medical technologies
The process for the introduction of a newmedical technology into the BBP catalogueis initiated by the Ministry of Health,which orders the President of the PolishHealth Technology Assessment Agency(AHTAPol), a body comparable to NICEin England, to make recommendations.AHTAPol has published guidelines onconducting a health technology assessment(HTA), which are strictly respected by theauthorities1.
Following a request from the Ministry ofHealth, the President of AHTAPol invitesopinions about the new technology from(i) National Consultant bodies in theappropriate medical specialisation and (ii)the NHF for financial concerns. These twogroups have thirty days to issue theiropinions, which are then passed on to aConsulting Committee (CC) workingunder AHTAPol umbrella. This CCanalyses the opinions and presents aposition to the President of AHTAPol assoon as possible. Finally the President ofAHTAPol will make recommendations tothe Ministry of Health based on the CC’sposition and the results of the assessment.
There are, however, several limitations inthis process including the lack of clear indi-cations on how the Ministry of Healthdecides when to initiate this process. There
HEALTH TECHNOLOGY ASSESSMENT
Developing HTA frameworks inemerging markets: the road ahead
The case of Poland
Maciej Nowicki
Maciej Nowicki is President of HTAAudit Nowicki Landa Partners, Poland.Until October 2010, he was Reimburse-ment Manager, Medtronic Poland, War-saw. Email: [email protected] * There are currently sixteen voivodship or provinces in Poland.
is also a lack of a clearly defined timeframefor the entire process and no clear defi-nition on how and by whom theassessment is performed. Moreover delaysare also due to the need for anannouncement of new technologiesthrough Government Orders. Theseannouncements are needed before theNHF starts negotiations with health careproviders.
Changes in the conditions for reimbursement
Changes in the conditions for proceduresor technologies in the BBP catalogue (suchas changes in ICD-9 or ICD-10 relatedcodes or hospital/department require-ments) must be initiated and approved bythe Ministry of Health. Applicants may beone of the following: the National Con-sultant body for the relevant medicalspecialisation; professional medical soci-eties via the National Consultants; thePresident of the NHF; societies and/orfoundations protecting patient rights(according to their statutory objectives) viathe National Consultants. The assessmentcriteria are the same as those for inclusionin the BBP catalogue. The limitationsdescribed previously in reimbursing newmedical technologies, also present barriersto any change in the catalogue. There arealso additional requirements to presentbasic information about epidemiology,determination of any societal healthimprovement and the financial implica-tions for the publicly funded health caresector.
Changes in the level of reimbursement
The Ministry of Health is also responsiblefor any change in the level of reim-bursement for a medical technology. Anapplication for change may be made byany of the bodies already identified. ThePresident of AHTAPol then produces aHTA report in respect of changes in thelevel of reimbursement; this is then con-sidered by the CC. The position of the CCis then submitted to the President ofAHTAPol who in turn makes a final rec-ommendation to the Ministry of Health onthe need for any change in the level ofreimbursement.
In additional to the barriers discussed pre-viously, one further key challenge is thelimited level of resources available withinAHTAPol to produce these HTA reports.Moreover new reimbursement rates haveto be announced in advance by the NHFto establish for contracts with health careproviders. There is also no direct and clear
relation between the AHTAPol’s recom-mendations, the Ministry of Healthdecision and NHF responsibility for theimplementation of any changes in rates ofreimbursement.
Reimbursement of Implantable MedicalDevices The idea of a BBP is still very fresh inPoland. In fact the Diagnosis RelatedGroup (DRG) system that was put in placein hospitals in 2009 drew on historical data.This means that today many of the proce-dures with implantable medical devices(IMDs) are reimbursed.
The DRG tariff includes the costs of hos-pital stay, medical service (surgery, nurseand medical care etc.), medical devices anddrugs, as well as other direct and indirectcosts. DRG tariffs are updated by theNHF on an annual basis with some correc-tions on a quarterly basis. However, theinitial use of historical data has meant thatthe level of the tariff used for reim-bursement is, in the majority of the cases,too low for health care providers. This hadled to long patient waiting lists for inno-vative procedures, as well as growing debtswithin hospitals.
Some examples of major procedures in thePolish DRG system with usage of IMDsinclude:
− Deep brain stimulation
− Spinal cord stimulation
− Implantation of ophthalmic lenses
− IMDs for hearing-impaired patients
− Angioplasty with bar stents/drugeluting stents
− ICD, pacemakers, CRT
− Orthopaedic surgery with implants(total knee replacement, total hipreplacement, spinal surgeries withdynamic stabilisation of vertebrae)
− Meshes in abdominal/uro-gynaecologysurgeries
For new innovative procedures that are notalready listed in the BBP catalogue, thereis an application pathway (see above),where HTA guidelines must be respectedby the applicant.
Future for Implantable Medical DevicesIn the future, one can expect growingdemand for IMDs in Poland. Firstly, this isdue to the constant increase in medicalknowledge and skills of the professionals.Secondly, there is a tendency for total andpublic health care expenditures to grow asnew innovative technologies replace oldand less effective surgeries. Thirdly, thereis growing awareness among patientsabout new technologies. Finally, theexpected development of private/alter-native health insurance will additionallyhave a positive impact on the developmentof implantable procedures in Poland.
REFERENCES
1. AHTAPol. Guidelines for ConductingHealth Technology Assessment (HTA), Version 2.1. Warsaw: Polish Agency forHealth Technology Assessment, 2009. At: http://www.aotm.gov.pl/assets/files/wytyczne_hta/2009/09.06.29_wytyczne_HTA_eng_MS.pdf
ACKNOWLEDGMENT
The papers on health technology assess-ment follow on from an expert meeting on“The development of HTA for im-plantable medical devices in emergingmarkets”, held in Prague in March 2010and funded by Medtronic Trading NLBV. The views expressed in these articlesare those of the authors alone and notnecessarily those of Medtronic TradingNL BV.
Eurohealth Vol 16 No 417
HEALTH TECHNOLOGY ASSESSMENT
San Servolo, Venice, Italy24–30 July 2011
The Ageing Crisis: A Health Systems Response
More information is available at:www.healthobservatory.eu
The Summer School provides a chance to spend a week workingintensely with other senior to mid-level health policy makers,planners and professionals with expert support to marshal theevidence on ageing, to review what it means for health systemsand to share experiences of responding through policy and inpractice.
The Summer School addresses a fundamental change that affectsthe entire health system in its widest sense and sectors beyond. Itcreates a chance for you to focus on state-of- the-art knowledgewith your peers and to build lasting networks across Europe.
Early applications are encouraged as places are limited.
Observatory Venice Summer School
Eurohealth Vol 16 No 4 18
Ensuring equal access to effective treat-ments for individuals in equal need ofhealth care, regardless of their country oforigin, is a fundamental goal for any healthcare system. The Spanish case is relevantfrom a policy perspective, given that therapid increase in immigration has placedimportant pressures on health expenditurein a health system where virtually all thepopulation are legally entitled to freeaccess to health care. While a growingbody of literature in Spain has exploredwhether, despite the universality of healthbenefits, differences in health status and inthe utilisation of health services existbetween immigrants and the Spanish pop-ulation, differences in the consumption ofmedications or self-medicated drug usehave received less attention. The commonpractice in many countries of consumingdrugs without a medical prescription couldnot only have important direct conse-quences for the health of the individual butalso considerable unintended conse-quences for the health of the population atthe community level, namely that an inad-
equate consumption of medications mightreduce drug resistance. In Spain both thedemand for and sale of drugs without theneed for a medical prescription is a rela-tively frequent phenomenon. As a con-sequence, the Spanish Ministry of Healthhas now launched specific campaignsaimed at improving the rational use ofmedicines.
The international contextThe international literature, mainly fromthe United States, provides evidence of sig-nificant differences in the consumption ofpharmaceuticals by immigrant popula-tions. For example, one study found thatBlack or Hispanic users of Medicareconsume fewer pharmaceuticals thanWhite users with the same chronic illnessand pharmaceutical coverage. Anotherimportant conclusion of this study is thatthe type of pharmaceutical consumed byethnic minorities is also cheaper.1 Morerecently, another US study confirmed theseresults, showing that a large proportion ofthe disparities in out-of-pocket expen-diture and in the consumption andexpenditure in pharmaceuticals of White,Black and Hispanic ethnic minorities arenot completely due to differences in pop-ulation characteristics, such as the lowersocioeconomic status of minority groups,but to factors related to the race or eth-nicity of the individual.2 The authorsattribute ethnic inequalities in the con-sumption of pharmaceuticals to the
scepticism of these patients with respect tomedicine and health care in general, lowercompliance with medical advice, commu-nication problems with doctors andpossibly differences in physician pre-scribing habits.
The Spanish caseWhile there is a growing number of studiesin Spain that explore differences in healthand health care use between immigrantsand Spaniards, the literature on differencesin pharmaceutical consumption is limited.One recent report shows that the (age–sexadjusted) pharmaceutical spending ofimmigrants is much lower than that oftheir Spanish counterparts.3 The findingsof another study in the city of Lleida inCatalonia suggest that both pharmaceuticaldrug spending and drug consumption arelower for non-Spanish-born individualsrelative to Spanish-born individuals of thesame age and sex4. Finally, one study usingdata from the 2003 Spanish NationalHealth Survey also reaches similar conclu-sions.5 However this study found nosignificant difference between the Spanishnational and non-national populations inself-medication patterns.
Another study has made use of the 2006Spanish National Health Survey. Thissurvey includes a sufficiently large sampleof the foreign-born population.6 The useof this survey allowed the authors to makea detailed comparison of drug con-sumption between Spaniards and several
HEALTH POLICY DEVELOPMENTS
Spain: the effect of country of birthon patterns of pharmaceutical use
Dolores Jiménez Rubio and Cristina Hernández Quevedo
Summary: Despite the universality of health care in Spain for virtually all of the population, irrespective of nationality or country of origin, there is substantial evidence that the level of health and especially the use of health services differs in important ways between immigrants and the Spanish-born population. Differences inpharmaceutical use on the basis of immigrant status have, however, received muchless attention. This study reviews the limited evidence in Spain on this issue, finding a lower consumption of medicines by some immigrant groups relative to Spaniards.
Key words: immigrants, Spain, access, drug consumption, self-medication
Dolores Jiménez Rubio is Associate Professor, Department of Applied Economics, University of Granada, Spain.
Cristina Hernández-Quevedo is ResearchOfficer, European Observatory on HealthSystems and Policies, LSE Health, London School of Economics and PoliticalScience, UK. Email: [email protected]
Eurohealth Vol 16 No 419
categories of immigrants, thus taking intoaccount the heterogeneity inherent to theimmigrant population living in Spain. Theanalysis is based on a multilevel multin-omial probit model that compares threeconsumption options (no consumption ofdrugs, consumption of prescribed drugsand self-medicated consumption) for thefive most consumed drugs in Spain. Evi-dence from this study suggests that thereare some important differences in pharma-ceutical consumption linked to country ofbirth. In particular, Africans, Europeans(from non European Union countries) andEuropean Union individuals show a lowerprobability of consuming prescriptionmedicines than Spaniards, while citizensfrom the European Union and Africa alsoshow a higher probability of using no drugtreatment at all for the same level of need.Interestingly, the results obtained by thisstudy reveal that for Romanian born cit-izens the probability of consumingmedicines without a medical prescriptionis higher than for Spanish born citizens,while individuals born in the EuropeanUnion have a lower probability of self-medication.
While there are many factors that couldexplain differences in prescribed con-sumption and no consumption ofmedicines,2 the observed disparities in pat-terns of self-medication could be attributedto cultural differences. This is becauseaccording to one recent survey of nineteenEuropean countries, Romania has one ofthe highest self-medication rates forantimicrobial drugs, while other Europeancountries show lower self-medication ratesthan Spain.7
Another important result from this studyis that there are factors, in addition to thoseaccounting for the effect of cost sharing,such as health limitations and retirementstatus, that are relevant in explaining drugconsumption in Spain. In particular, beingin receipt of private insurance is found tobe associated with a higher probability ofdrug consumption, implying that theactual cost sharing structure in Spain,which is not means tested, may generateinequalities in access to drugs, particularlyfor poorer individuals who do not meet ageand disability criteria to be exempt fromco-payments.
Key conclusionsThe rapid increase in the immigration phe-nomenon in Spain has placed importantpressures on health care expenditure in ahealth system where virtually all the pop-
ulation is legally entitled to free access tohealth care. While there is a growing bodyof research in Spain that analyses whether,despite the universality of health benefits,differences in health status and health careaccess exist on the basis of the country oforigin of an individual, to date there islimited evidence on the existence of differ-ences in the consumption of prescriptionmedicines or self-medication.
According to the most recent empirical lit-erature reviewed in this article, in Spain, asin other countries with a longer traditionas immigrant recipient countries such asthe United States, consumption of medi-cines varies by country of birth. Overall,immigrants tend to consume fewer phar-maceuticals and are more likely not to haveany treatment at all compared to Spaniardswith the same illness and socioeconomiccharacteristics. A small group of immi-grants, however, tend to have higher selfmedication rates than the Spanish popu-lation, which all else being equal isprobably due to cultural factors.
The differences in the use of health servicesand in the consumption of medicines inSpain suggest that the Spanish NationalHealth System has an important role toplay in the design of more effective healthservices for immigrants. Policy proposalshave been put forward and discussed else-where.8 Given the decentralisation of thehealth system, it is expected that only thoseregions with a higher proportion of immi-grants in their total population will bringforward measures to better integrate immi-grant groups.
However, the reduction in the foreign-born population now being observed as aconsequence of the current economicrecession in Spain might reduce incentivesto adopt new measures to improve theaccess of ethnic minorities to healthservices. At the same time, if the arrival ofnew immigrants decreases, it is likely thatthe differences in pharmaceutical usebetween established immigrants and thenative population will narrow significantly,since most of the international evidencesuggests that disparities in the use of healthservices tend to decrease with the numberof years in the recipient country.
There is a wide scope for future research inthis area. Most of the limitations of studiesin this area are related to data availability.If data become available, it would be veryinteresting to explore whether divergencesin drug consumption really tend to reducewith the number of years living in Spain.
Also, future studies may considerexploring the links between disparities indrug consumption related to country ofbirth and inequalities in health, or in accessto medications, respectively.
REFERENCES
1. Briesacher BA, Limcangco R, GaskinDJ. Racial and ethnic disparities in prescription coverage and medication use.Health Care Financing Review2003;25(2):63–76.
2. Gaskin DJ, Briesacher BA, LimcangcoR, Brigantti LB. Exploring racial and ethnicdisparities in prescription drug spendingand use among Medicare beneficiaries.American Journal of Geriatric Pharmacotherapy 2006;4(2):96–111.
3. Casado Marín D, Puig Junoy J, PuigPeiró R. El impacto de la demografía sobreel gasto sanitario futuro de las Comunidades Autónomas. [The impact ofdemography on future health spending inthe Autonomous Communities] Madrid:Fundación Pfizer, 2009. Available athttp://www.fundacionpfizer.org/docs/pdf/publicaciones/documentos_trabajo/Impacto_demografia_gasto_sanitario.pdf
4. Rue M, Serna MC, Soler-González J,Bosch A, Ruiz-Magaz MC, Galvan L. Differences in pharmaceutical consumptionand expenses between immigrant and Spanish-born populations in Lleida,(Spain): A 6-months prospective observa-tional study. BMC Health Services Research 2008;8(35)
5. Carrasco R, Jimeno JF, Ortega AC. Losefectos de la inmigración sobre las condi-ciones de los trabajadores nativos en elmercado de trabajo: evidencia para España.[The effect of immigration on the conditionof native workers in the labour market: evidence from Spain. In: Aja E, Arango J,Oliver J (eds). La inmigración en la encrucijada. Anuario de la inmigración en España. [Immigration at the crossroads.Yearbook of Immigration in Spain]Barcelona: Cidob edicions, 2008
6. Jiménez-Rubio D, Hernández-QuevedoC. Explaining the demand for pharmaceuti-cals in Spain: are there differences in drugconsumption between foreigners and theSpanish population? Health Policy2010;97:217–24.
7. Grigoryan L et al. Self-medication withantimicrobial drugs in Europe. EmergingInfectious Disease 2006;12(3):452–59.
8. Hernández-Quevedo C, Jiménez-RubioD. New citizens, new challenges for theSpanish National Health System, Eurohealth 2010;16(1):24 –25.
HEALTH POLICY DEVELOPMENTS
Eurohealth Vol 16 No 4 20
HEALTH POLICY DEVELOPMENTS
As part of Minister of Health and SocialWelfare Darko Milinovic’s overall healthcare reform, in 2009 and 2010 Croatia sub-stantially reformed its pricing andreimbursement regulation for medicines.The main goals of the reform were to (a) maximise value for tax payers’ money,(b) improve efficiency and transparency inhigh level decision making, and (c) ensureethical medicines promotion practices. Theresults of the reform enabled the Croatiannational health insurance fund (CroatianInstitute for Health Insurance – HZZO) togenerate extensive savings, while at thesame time improving access to innovativemedicines.
In 2009, HZZO expenditure on pre-scription medicines amounted to 2.9billion Kune (kn) (€393 million)*, with anadditional 2 billion kn (€271 million) spenton hospital medicines, of which HRK480million (€65 million) went on expensiveproducts funded from a budget separate tothat for regular hospital expenditure. Dueto the introduction of modest co-payments
(15kn or €2 per prescription) and ref-erence pricing, HZZO expenditure onprescription medicines decreased by 2.9%in comparison with 2008.1
In the twelve month period from July 2009to July 2010 as many as 47 innovative mol-ecules were added to the different HZZOlists of reimbursed medicines and thirteeninnovative molecules to its list of expensivehospital medicines. For comparison, a totalof 45 products were listed in the periodfrom 2002 to 2009. Comparing expen-diture in the first six months of 2009 and2010, HZZO expenditure on prescriptionmedicines decreased by an additional 13%from 1.7 to 1.5 billion kn (€230.5 to€203.4 million), while its expenditure onexpensive hospital medicines decreased by28.5% from 219 to 157 million kn (€30 to€21 million). Total savings generated bythe reform across the two periods amountsto 295 million kn ( €40 million). HZZOdue arrears have also substantiallydecreased, from 1.3 to 1 billion kn (€176to €135.6 million), a 22% reduction.2
So what did the reforms involve? We nowsummarise the pricing and reimbursementsystem in Croatia along with the majorchanges introduced by the reform.
The pharmaceutical pricing and reimbursement systemThe HZZO holds a virtual monopsony onpricing and reimbursement in the marketsfor prescription and hospital medicines.Only HZZO contracted hospitals andprimary care physicians can prescribe med-icines that are paid by mandatory healthinsurance. The HZZO implements twolists: the ‘basic’ list with all essential medi-cines covered by mandatory insurance, andthe ‘complementary’ list with medicinescovered partially through mandatoryinsurance and partially by out-of-pocketpayments. Applications for reimbursementare submitted to the HZZO Committeefor Medicines for consideration. The com-mittee delivers a non-binding opinion onall applications to the HZZO managementboard, which makes the final decision.
In Croatia, international price comparisonsare used for setting maximum wholesaleprices (Table 1). The system takes intoaccount drug prices in Italy, France andSlovenia. Prices in Spain and the CzechRepublic are consulted if data from Italy,France and Slovenia are not available.
The HZZO also sets reimbursement limitsfor most prescription medicines throughannual internal reference pricing. Forty-one clusters are formed at AnatomicalTherapeutic Chemical Classification
Croatia: 2009/2010 pharmaceuticalpricing and reimbursement reform
Luka Voncina and Tihomir Strizrep
Summary: In 2009/2010, Croatia substantially reformed its pricing and reimbursement regulation of medicines with the aims of maximising value for invested funds, increasing efficiency and transparency in high level decision making,as well as ensuring ethical pharmaceutical marketing practices. Most notably, the reform measures included: clearly defined judgment criteria and full public disclosureof the reimbursement decision-making process; pricing reforms; strengthening of evidence-based medicine and health economic requirements for submissions; payback, rebate and cross-product agreements; and mandatory reporting of promotionalexpenses and all financial transactions between pharmaceutical companies and doctors employed by the public health care system.
Key words: Pricing, reimbursement, medicines, transparency, value for money
Luka Voncina is Head of Department forDrugs and Medical Products and TihomirStrizrep is Managing Director, CroatianInstitute for Health Insurance, Zagreb,Croatia. Email: [email protected] * One Croatian kuna equals €0.135
Eurohealth Vol 16 No 421
(ATC) levels 3, 4 and 5* using the DefinedDaily Dose (DDD) approach. Payment isonly granted up to the level of the ref-erence price, while the difference with theactual market price has to be paid by thepatient if the company does not accept thereference price (the B list). Companies mayopt to negotiate a higher price than the onedetermined through the reference pricingmechanism, but are obliged to generateequivalent savings to the HZZO throughprice decreases on other products orthrough rebate agreements.
The reform: improved decision makingand transparencyTwo ordinances that regulate the marketintroduced most of the reform measures:one ordinance established the criteria forwholesale pricing and reporting of thewholesale prices of medicines and a secondordinance established the criteria forinclusion of medicines in the basic and sup-plementary reimbursement lists of theHZZO.3
As a result of the reform, applications forthe inclusion of productions on any of theHZZO lists are now published on theHZZO web page (http://www.hzzo-net.hr) within five working days of receipt.The information includes the identity ofthe applicant, the date of applicationreceipt and the subject of the application.The list of HZZO Committee forMedicinal Products members with shortCVs, as well as the dates and agendas ofcommittee sessions, are also publishedonline.
Improvements have been made in the com-mittee’s methodology for makingrecommendations and transparency hasbeen increased. The committee now
operates in two semi-annual cycles. Thecycles consist of four regular sessionswhere the committee discusses submittedapplications and a fifth regular sessionwhere it ranks the applications in terms ofthose that may increase HZZO drugexpenditure. Ranking is undertaken usinga Delphi process – a consensus buildingmethod ensuring that all members of thecommittee carry equal weight in thedecision-making process.
In addition, the new ordinances introduceddetailed criteria on which the committeemust base their recommendations. Theseinclude: (a) the product’s importance fromthe public health perspective; (b) its thera-peutic importance; (c) its relativetherapeutic value; (d) an assessment ofethical aspects; and (e) the quality and reli-ability of data and assessments fromreference sources. For example, withregard to relative therapeutic value, aproduct may be classified in one of threegroups:
1. A product with new therapeutic value,when it concerns a medicinal product fortreatment or prevention of diseases, condi-tions or disorders with no currentlyavailable effective treatment.
2. A product with added therapeutic valuewhen, compared to a standard or typicalmedicinal product or treatment, it refers to:
– more favourable effect on finaltreatment results,
– more favourable effect on substitutetreatment results,
– more favourable effect on quality of life,
– efficient treatment of disease symptoms,
– improved safety profile of a medicinalproduct,
– a more patient-friendly use of amedicinal product,
3. A product without proof of new oradded therapeutic value.
Furthermore, there are increased require-ments in the application which thecommittee assesses. Most importantly,these include having a tabular presentationof the status of the product in respect ofhealth insurance or health care systems ofall Member States of the European Unionand, if available, a decision or opinionabout financing of the product issued bythe competent authority engaged in healthtechnology assessment. Informationshould also be presented on indicationsand instructions for use, the amountcovered by compulsory health insurance,any surcharges and other information rel-evant to the financing of the medicinalproduct in individual Member States. Sci-entific evidence must also be presenteddemonstrating the advantages of themedicinal product for suggested indi-cation(s) over comparator treatments,primarily over medicinal products alreadyincluded in the basic or supplementaryreimbursement lists of the Institute. Metaanalyses and systematic appraisals shouldbe presented where available.
The therapeutic guidelines of bothCroatian and European expert associationsfor indications for which an application hasbeen submitted will be taken into account.A description of current clinical practice inCroatia by indication for which the appli-cation has been submitted and for whichthe medicinal products already included inthe Institute's lists are used, must be pro-vided along with comments on efficacy andsafety, and a table comparing the relativeprice of treatment. There is also arequirement for a description and analysisof the effect of the use of the new pharma-cological therapy on patient health careresulting from the inclusion of themedicinal product on the list (including theuse of complementary products andservices). An estimate of the number ofpatients likely to receive the product overa three-year period is also required, as wellas an estimate of the proportion of patientswho could only be satisfactorily treatedwith the new medicinal product, comparedto those satisfactorily treated withproducts already on the Institute'sapproved lists.
Criteria for the inclusion of products in theHZZO list of expensive products have alsobeen defined. These include a need to show
HEALTH POLICY DEVELOPMENTS
Table 1: HZZO international price comparison mechanism for setting maximum wholesale prices
Listed drugs determined through annual price recalculations
New drugs introduced to lists
Drugs protected under patent in Croatia orany EU member state: up to 90% of the average price in Italy, France and Slovenia.
Original breakthrough products: up to 100% of theaverage price in Italy, France and Slovenia.
Drugs not under patent in Croatia or any EU member state: up to 65% of the averageprice in Italy, France and Slovenia.
Original ‘me-too’ products: up to 90% of the averageprice of equivalent drugs in Croatia
Generic products: up to 70% of the average price inItaly, France and Slovenia and up to 90% of the priceof the last bioequivalent generic introduced to the list.
* Level 3 corresponds to the therapeutic/pharmacological subgroup; level 4 to the chemical/therapeutic/pharmacological subgroup; and level 5 to the chemical substance.
Eurohealth Vol 16 No 4 22
that use of the product represents a break-through in the risk-benefit ratio oftreatment for a given indication, in com-parison with medicinal products alreadyincluded in the basic reimbursement list ofthe Institute. The product must beintended for hospital use and not subjectto medical prescription. Both guidelinesfor prescription, as well as the clinicalpathway for the condition for which themedicinal product is to used, must bestrictly defined by the Croatian MedicalAssociation. There must be no genericequivalent or the product must be on theEuropean Commission Register of Desig-nated Orphan Medicinal Products. Interms of cost, a budget impact analysismust demonstrate that use of the productcould not be financed through routine hos-pital budgets because of the very hightreatment costs. It should also be noted ifproducts with similar therapeutic andpharmacological properties, but highertherapy costs, are already included in thelist of expensive medicinal products.
One additional change introduced as partof the reforms means that when a companynow wishes to appeal against a decisionmade by the HZZO management board onthe listing of a medicinal product, the casemust proceed to court, unlike the situationpreviously where arbitration procedureswere used.
Ensuring value for tax payers’ money All applications for reimbursement have tobe accompanied by budget impactanalyses. These are undertaken accordingto strict criteria that largely adhere toISPOR (International Society for Pharma-coeconomics and Outcomes Research)principles of good practice for budgetimpact analysis.
The financing of ‘expensive products’ isnow regulated by payback agreementsconcluded between the marketing authori-sation holder and the HZZO. The HZZOfinances the treatment of a preciselydefined number of insurants (based on theresults of the budget impact analysis),while the marketing authorisation holderensures the supply of its medicinal productto additional insurants (if needed) at itsown cost through donations or pays backthe overspend to the HZZO. Prices canalso be determined using a cascadingapproach with regard to the number ofinsurants receiving the medicinal product.
When concluding the agreement, theHZZO takes into account the total con-sumption of all medicinal products for the
given therapeutic indication. This cantranslate to disease-wide agreements for allmarket authorisation holders withmedicinal products for a particular con-dition. The new byelaws also introducecross product agreements. Applicants areallowed to submit binding offers where theapplication, which refers to the productconsidered by the Committee forMedicinal Products, is connected with aparallel proposal for the reduction in theprice of the medicinal product alreadyincluded in the Institute’s basic reim-bursement list. In this way new drugs areadded to HZZO lists without additionalcosts, as the costs borne by the intro-duction of new products are offset throughsavings achieved by price reductions inproducts that are already reimbursed.
Furthermore, internal reference pricing isnow better regulated. Groups are formedat the third or higher ATC levels. Ref-erence prices are determined (to a largeextent by taking account of the price byDDD) by unit dosage form for the same orsimilar pharmaceutical forms for eachstrength level of the active substance andeach pack size separately. Reference pricesare determined on the basis of the lowestprice of a product which recorded at least5% of sales within a therapeutic groupover a twelve month period preceding thereference pricing process. This principlewas adopted to avoid the possibility ofmarket shortages.
EthicsAll applicants to the lists are obliged toenter into a uniform agreement on theethical promotion of medicines. Thisentails substantial financial penalties forunethical promotion. The main features ofthe agreement are shown in the panelabove.
All features of the agreement apply to thirdpersons working on behalf of the mar-keting authorisation holder. A financialrevolving deposit mechanism has nowbeen put in place to guarantee implemen-tation. Companies are obliged to deposittheir promotional budgets (estimated inthe first year of agreement implementationat a minimum of 3% of annual revenuefrom the HZZO) to the HZZO in quar-terly instalments and present all promotionbased expenses, including all payments toindividuals employed in the public system,quarterly. Payback of the funds in questionis also delivered quarterly.
Penalties for unethical promotion includedelisting, informing the general population
of unethical behaviour and withdrawal (inpart or total) of the quarterly deposit. TheHZZO Committee for Medicinal Productsthen functions as the arbiter ensuring theimplementation of the agreement, whilethe management board takes any finaldecision on any punishments and penaltiesto be incurred.
REFERENCES
1. HZZO. Izvješce o poslovanju hrvatskogzavoda za zdravstveno osiguranje za 2009[Report of the Croatian Institute forHealth Insurance 2009]. Zagreb: HZZO,2010. Available at http://www.hzzo-net.hr/dload/publikacije/Izvjesce_o_financijskom_poslovanju.pdf
2. HZZO. Izvješce o poslovanju hrvatskogzavoda za zdravstveno osiguranje za i.–vi.2010 [Report of Croatian Institute forHealth Insurance, January to June 2010].Zagreb: HZZO, 2010. Available athttp://www.hzzo-net.hr/dload/publikacije/Izvjesce_o_poslovanju_od_01_do_06_2010.pdf
3. National Gazette 2009. No 155.
HEALTH POLICY DEVELOPMENTS
Key features of uniform agreement on theethical promotion of medicines
Mandatory reporting of all promotional expenses and financial transactions betweencompanies and doctors employed by the public health care system.
Ban on advertising and distribution of prescription drugs to the general population.
Ban on informing the general population of ongoing applications to avoid unethical pressure on the HZZO Committee for Medicinal Products.
Ban on promotion targeted at doctors based on information that has not been scientificallyproven.
Ban on financial remuneration or remuner-ation of any kind to doctors for prescribing.
All promotional events have to be educationaland professional. They may not include morethan 25% of time for unprofessional activities.
Companies must provide detailed informationto the HZZO of any organised promotionalevents 15 days in advance.
The HZZO has to be notified of all clinical studies, including post marketing surveys.
Representation costs are limited to 1,000 kn(€135) per doctor (does not include education).
Individual sales representatives are allowed 15 minutes contact time per doctor per month.
Eurohealth Vol 16 No 423
HEALTH POLICY DEVELOPMENTS
Recently, we published the 2010 HealthSystems in Transition review for theNetherlands.1 It is the first attempt to givea full blown description of the Dutchhealth system after major health reform in2006. This reform, introduced after almosttwo decades of preparation, has broughtimportant new regulatory mechanisms andstructures to the Dutch health system. Thereform can be seen as the realisation of along-standing political wish to unite theold sickness fund scheme, which coveredabout two-thirds of the population, andthe voluntary private health insurancescheme, for individuals with an incomeabove a certain threshold. As a regulatorymechanism the reform introducedmanaged competition among actors inhealth care. Early attempts to unite allhealth insurance schemes into a singlemandatory scheme failed at the beginningof the 1990s, mainly because of strongopposition from health insurers,
employers and physicians. During the1990s, however, smaller reforms origi-nating from early plans were graduallyimplemented. This helped pave the way forthe final and successful attempt at reformin 2006.
The reform’s rationale is threefold:
1. The new system aims to contain risinghealth expenditures by increasing healthsystem efficiency, i.e. higher quality atlower costs, through the introduction ofmanaged competition.
2. The reform aimed to reduce inequity inthe system. Age, income and health statusall had a potential influence on insuranceform, contribution level and access tohealth services. Most notably, high-riskindividuals with incomes above thethreshold and whose only option was topurchase private health insurance werenegatively affected by risk selection and
high premiums. Under the new systemeverybody is insured under the same con-ditions and all health insurers are obligedto accept all individuals.
3. It was hoped the new system wouldincrease transparency. The old system wascharacterised by a high level of governmentintervention, resulting in a fragmentedinsurance market with complex rules andregulations, especially from the perspectiveof the individual.
Although the major political parties agreedon the goal of uniting the health insurancescheme, some key aspects of the systemwere heavily debated political decisions.Basically two models were discussed: (i) amodel with community-rated premiumsand (ii) a model with income-related con-tributions, as preferred by the opposition.Furthermore, discussions involved thedecision to choose either a system underprivate law with strong government guar-antees or a system under public law withsome market mechanisms. In the end thethen ruling coalition of ChristianDemocrats and Liberals adopted the modelof community-rated premiums underprivate law.
Managed competition in the Netherlands: an example for others?
Ewout van Ginneken, Willemijn Schäfer and Madelon Kroneman
Summary: The introduction of managed competition in the Netherlands in 2006 fundamentally changed the roles of patients, insurers, providers and the government.Health insurers are expected to negotiate with providers and purchase efficient careof good quality. Patients are expected to critically assess and select the health insurerand provider of their choice. In this ongoing transition process all players should re-ceive the appropriate tools to fulfil these roles. Important challenges remain: patientinformation on price and quality should be continuously improved; the risk adjust-ment system needs continuous refining; quality has to be made visible and measura-ble; the DBC (Diagnose Behandeling Combinatie) system, comparable to a DRGsystem, must be reformed; and the negotiation and purchasing process should be optimised and shortened. Other countries planning to introduce a similar system canlearn from the Dutch experience. The introduction of managed competition is notmerely a simple exercise but a process that requires continuous efforts from all marketplayers.
Key words: Health reform, managed competition, health financing, the Netherlands
Ewout van Ginneken is Senior Researcher in the Department of Health Care Management at the Berlin University of Technology. Willemijn Schäfer is Researcher andMadelon Kroneman Senior Researcher at the Netherlands Institute for Health ServicesResearch (NIVEL), the Netherlands. Email: [email protected]
In this review, we examine managed com-petition in the Netherlands almost fiveyears after its introduction. After adescription of the system, some importantchallenges will be discussed. We concludewith a discussion of the system and itslessons for countries contemplating theintroduction of a similar system.
Main elements of managed competitionin the NetherlandsThe 2006 Health Insurance Act(Zorgverzekeringswet, Zvw) and theHealth Care Market Regulation Act (Wetmarktordening gezondheidszorg, Wmg)were introduced as a legislative frameworkfor managed competition. This fundamen-tally changed the role of the players in theDutch health system. The role of the gov-ernment was envisaged to change fromdirect control of volumes, prices and pro-ductive capacity to safeguarding theprocess from a distance. Responsibilitieshave been transferred to insurers,providers and the insured individuals. Thegovernment supervises the quality, accessi-bility and affordability of health care. Thehealth insurers, health care providers andthe insured or patients are the market
players. Interactions between these playerstake place in three markets: the markets forhealth insurance, health care provision andhealth care purchasing (see Figure 1). Theestablishment of new ‘watchdog’ agenciesin the health sector aims to avoid undesiredmarket effects in the new system.
Health insurance market
In the health insurance market, individualsare obliged to purchase their basic healthinsurance from health insurers. Healthinsurers must compete on price and qualityand have to accept all individuals. Healthinsurers are not allowed to differentiatetheir premiums according to the riskprofile of the applicants (communityrating). Tax subsidies, called health careallowances, partly compensate those onlower incomes for their health insurancecosts. Basic health insurance coversessential curative care tested against the cri-teria of demonstrable efficacy,cost-effectiveness and the need for col-lective financing. The basic healthinsurance benefit package is determined bythe Ministry of Health Welfare and Sportbased on the advice of the HealthInsurance Board (CVZ). Individuals are
free to choose their health insurer, level oftheir voluntary deductible (€0 –€500),reimbursement or an in-kind policy andswitch insurers every year.
If an individual opts for an in-kind policy,choices between providers can be restrictedto contracted providers, but financial riskwill be absent. If the insured individualnevertheless wants to visit a non-con-tracted provider, additional out-of-pocket(OOP) payments may apply. When anindividual opts for a reimbursement policy,a free choice of provider exists, but alsohere there is a reimbursement limit that insome cases could lead to additional OOPpayments. In addition, a compulsorydeductible (currently €170) is applied.However, both the voluntary and the com-pulsory deductible do not apply to generalpractitioner care (GP), maternity care anddental care for those under the age of 18.The government committed itself toprovide information on health plans interms of price, quality, and benefits. Thisshould help individuals in makinginformed choices, which is essential for theproper functioning of the competitiveinsurance market.
An interesting feature of the Dutch systemis the collective contract. Collective con-tracts are established between groups ofinsured and the health insurer. Healthinsurers may offer a maximum 10%reduction on the individual premium. Col-lective arrangements can be made byseveral legal bodies such as employers andpatient organisations. This system shouldgive the insured more influence (‘voice’)with the health insurers.2
Besides basic health insurance, patientsmay purchase complementary voluntaryhealth insurance (VHI) from any healthinsurer. Complementary VHI may onlycover health services that are not coveredunder basic health insurance or the long-term care insurance scheme, regulated bythe Exceptional Medical Expenses Act(Algemene Wet Bijzondere Ziektekosten,AWBZ). Health insurers may use risk-rating and are not obliged to acceptindividuals for VHI. Consequently, choiceon complementary VHI can be limited forpatients.
Health care purchasing market
In the health care purchasing market healthinsurers can negotiate with providers onprice, volume and quality of care. In thisprocess, insurers are free to use selectivecontracting. The use of these tools shouldresult in the purchasing of efficient care.
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HEALTH POLICY DEVELOPMENTS
Figure 1. Netherlands health care market interactions
Source: authors’ own compilation
INSURED/PATIENTS
health insurancemarket
health care purchasing market
health care provision market
price,quality,
VHI
quality, waiting times, price
selectivecontracting based onquality and costs
Government(regulation and supervision)
Dutch Health Care Authority (Nederlandse Zorgautoriteit, NZa)
HEALTH INSURERS
PROVIDERS
The payment mechanisms of the healthcare providers have also changed to accom-modate negotiations and competition. Acase-mix related financing system becamenecessary in which money would followthe patient.
GPs are now paid via a combination ofcapitation fees and fee-for-service. So far,these fees are negotiated centrally betweenthe National Association of General Prac-titioners (LHV), Health InsurersNetherlands (Zorgverzekeraars Ned-erland) and the Ministry of Health,Welfare and Sport. However, direct nego-tiation between insurers and GPs for lowerfees is allowed.
For hospital care an elaborate diagnosis-related groups (DRG)-type system calledDiagnosis and Treatment Combinations(Diagnose Behandeling Combinaties,DBCs) has been in place since 2005. Freelynegotiable DBCs can be negotiatedbetween insurers and providers, on price,volume and quality. They are introducedgradually, amongst other reasons to givethe health insurers time to build up thenecessary expertise and experience toassume their purchasing role. For example,in 2005, freely negotiable DBCs accountedfor 7% of annual hospital turnover. In2010, this percentage stood at 34%. For theremaining DBCs the Dutch Health CareAuthority (NZa) establishes the prices;insurers and providers can only negotiatevolume and quality.
Health care provision market
In the health care provision market,providers should compete for patients onthe basis of quality of care. The gov-ernment provides information on qualityand waiting times of providers so that indi-viduals can make informed choices. Thisassumes, however, that individuals arewilling or able to make these choices andhave a free choice of provider. Yet the lattermay be restricted if the individual chose anin-kind basic health insurance plan withselectively contracted providers and if theindividual faces access barriers, such aswaiting lists or travel distance for certainproviders.
Financing of the scheme
All Dutch residents contribute to thisscheme in two ways. First, they pay pre-miums, directly to the health insurer oftheir choice. Second, an income-dependentemployer contribution is deductedthrough their payroll and transferred to theHealth Insurance Fund (HIF). Children up
to the age of eighteen are covered throughone of their parent’s health plans. The gov-ernment makes a payment on their behalfdirectly into the HIF. The resources fromthis fund are then allocated among thehealth insurers according to a sophisticatedrisk-adjustment scheme, which wasinherited from the former sickness fundscheme. A well functioning riskadjustment scheme should make bothgood and bad risks equally attractive toinsurers through adjusted financial com-pensation. This should guarantee access toaffordable care for all citizens and takeaway the incentive for risk-selection. Riskadjustment is an essential precondition forreaping the benefits of a competitive healthinsurance market.3
Supervision of the scheme
Competition in health care may lead toundesired market effects. The Health CareNZa, an independent administrative bodyestablished in 2006 and funded by the Min-istry of Health, Welfare and Sport, isresponsible for the supervision of the threehealth care markets in the Netherlands andthe lawful implementation of the HealthInsurance Act. The NZa may impose tariffand performance regulation and imposespecific sanctions on players that haveobtained significant market power.
Four bottlenecks in the Dutch version ofmanaged competitionAlmost five years after its implementation,it has been a steep learning curve for allmarket players. Many short-termproblems needed immediate attention. Toname but a few, competition on premiumsled to financial problems for manyinsurers; a wave of mergers resulted in justfour insurers having 88% of the market;excessive DBC tariffs led to overfunding ofhospitals, which then had to be paid back;GP payments were delayed; GPs receivedmore funding than anticipated; and thereremained a pervasive problem with unin-sured individuals and defaulters. All ofthese problems had (and still have) to bedealt with on an ad hoc basis. On a positivenote, although the demands on all actorshave been high the situation has neverbecome chaotic.
Below, we will not focus on these issues,but rather on some structural problemsthat still need to be solved for managedcompetition to work. Particular attentionwill be paid to those aspects which arecrucial for the different market players tofulfil their roles.
Patient information
Patients are assumed to make informedchoices while selecting their health careproviders. This requires sufficient andreliable information being readily availablefor patients. Improvements in this area areneeded. Many initiatives have been madeto make quality of care more transparent.For example, the government providesinformation on waiting lists, quality andprices of care through the Internet(www.kiesbeter.nl). However, this infor-mation is far from complete and theinformation needs differ strongly betweenpatients. Information on performance ofthe various health care institutions onlymeets the demands of a limited group ofpatients with a limited set of healthproblems.4 In addition, the NZa concludedthat more time would be needed to achievean efficient provision of information thatmatches the needs of patients.5 In addition,patients may have to visit a preferredprovider of their insurer or risk making anadditional payment OOP. Insured indi-viduals will have to rely on their insurer tocontract care of good quality on theirbehalf. A future issue for debate for theDutch government will be whether freechoice of provider will remain an integralpart of the system or that insurers willbecome agents for the insured.
The health insurance market on the wholeseems to function better than the healthprovision market. Individuals mostlychoose their health plan based on easy-to-compare price information. However, theservice level of the insurer, largely similarwith only four major insurers left, or thequality of purchased care, which is difficultto assess for individuals, play a smaller role.6 Furthermore 64% of individuals arecovered by collective contracts.7 Sincemost group contracts are negotiated onpremium level, not on the basis of thequality of the contracted care, qualitychoices in this market do not yet influencethe quality of purchased care.6 As of 2010,the insurance market seems to have sta-bilised. It was only in 2006, the first yearof the new system, that a considerablenumber of people switched insurer (21%),8
many of them members of a renegotiatedcollective contract. In the period 2007–2009, the percentage of people switchinghealth insurers stabilised below 5%,9
which is the same percentage as under theold (pre-2006) sickness fund scheme.1
The negotiation process
At present, there are several problems that
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HEALTH POLICY DEVELOPMENTS
Eurohealth Vol 16 No 4 26
complicate the active purchasing role ofinsurers. First, contracting mainly focuseson price and volume, not on quality. Soundperformance indicators that health insurerscan use to evaluate the quality of providersare lacking. Second, an insufficient supplyof health care providers (in numbers andvariety) limits the possibilities for healthinsurers to selectively contract providers.In addition, health insurers fear damage totheir public image if a given hospital is notcontracted.10 Not surprisingly, selectivecontracting of providers is not yet verycommon.1,11 Third, the negotiationprocess between insurers and providersoften takes until the summer of a givenyear, whereas nominal premiums must beset on the 1st January.1 The former ismostly due to the late publicannouncement of any legal changes in theinsurer’s operating environment and thelarge number of DBCs that have to benegotiated. This complicates the con-tracting process and the setting of realisticpremiums. Moreover, new applicants donot know which care will be contractedand have to make choices on the basis ofincomplete information. This may seri-ously hamper patient mobility.10
The payment method for hospitals
The DBC system for hospital financing isnot yet stable and has led to the over-funding of hospitals and increasedbureaucracy. For each DBC a price iseither negotiated between a hospital andinsurer or settled by the NZa. There areproblems with the large number of DBCs(about 30,000). This complicates negotia-tions and the finalisation of contracts.Currently all actors in the field areworking on a major revision which shouldreduce the number of DBCs to 3,000. Thisshould simplify the contracting process.The new system should be implemented in2012. Furthermore, the DBC systemhinders an effective purchasing process.Because DBCs are reimbursed after com-pletion of treatment, the true financialresults in a given accounting year will onlybecome clear after a three-year delay.10
Finally, another important problem withthe DBC system is the remuneration of thephysician in each DBC. Since this sharedoes not always reflect reality, the incomesof some physicians have increased signifi-cantly.
Risk adjustment
The risk adjustment scheme needs constantrefining to eliminate perverse incentives forinsurers and to ensure fair competition.1 At
present, the scheme is not working opti-mally, in particular, for certain high riskgroups there are still failures within thescheme. This may lead to predictable lossesamong insurers which may in turn increasethe incentives for risk selection. Riskselection by health insurers for basic healthinsurance is difficult, since insurers areobliged to accept all applicants and theycannot raise the premium for individuals.However, there are several other opportu-nities for cream skimming. For example,complementary VHI can in theory be usedas a tool for risk selection. VHI can be soldat a low premium in combination withbasic health insurance to attract thoseinsured individuals with expected higherprofitability levels. So far, however, this hasnot led to cream skimming.10
ConclusionThe introduction of managed competitionin the Netherlands has attracted a greatdeal of international attention. Countriescontemplating the introduction of a similarsystem are well advised to follow thesedevelopments closely. Introducingmanaged competition, or more marketmechanisms, should not be underesti-mated. Shifting responsibilities to marketplayers does not mean that there is nothingleft for the government to do. The Dutchexperience demonstrates that even thoughcomplete chaos has not arisen, not every-thing has turned out in the way that wasanticipated. Many problems have had to besolved by ad hoc measures. Furthermore,managed competition is demanding on allplayers in the system, including the gov-ernment and its agencies. It clearly showsthe need to have a strong institutionalstructure in place, with enough techno-logical capacity and sufficient regulatorypower to manage such an innovativesystem.
The reform has changed the roles ofpatients, insurers, providers and the gov-ernment. Health insurers are expected tonegotiate with providers and purchase effi-cient care of good quality. Patients areexpected to critically assess and select thehealth insurer and provider of their choice.The government presumes that this willincrease efficiency and quality in the healthcare system, as well as make care moredemand-driven. However, this reform isstill in progress. In this transition processit seems critical that all players receive the appropriate tools to assume these roles. Important challenges remain: patientinformation on price and quality should be continuously improved; the risk
adjustment system needs continuousrefining; quality has to be made visible andmeasurable; the DBC system must bereformed; and the negotiation and pur-chasing process should be optimised andshortened. Not until the system is fullyimplemented, will we be able to evaluate ifmanaged competition has had the intendedeffects in terms of efficiency and quality.
REFERENCES
1. Schäfer W, Kroneman M, Boerma W etal. The Netherlands: health system review.Health Systems in Transition2010;12(1):1229
2. Groenewegen P, de Jong J. Dutch healthinsurance reform: the new role of collectives. Eurohealth 2007;13(2):10–13.
3. Van de Ven W, Beck K, Van de VoordeC, Wasem J, Zmora I. Risk adjustment andrisk selection in Europe: six year later.Health Policy 2007;83(2–3):162–79.
4. Berendsen A, de Jong G, Schuling J et al.De informatiebehoefte van de verwezen pa-tient [The information need of the referredpatient] Nederlands Tijdschrift voor Geneeskunde 2010;154:A1603.
5. Dutch Health Care Authority (NZa).Monitor ziekenhuiszorg 2009 [Hospitalcare monitor 2009] Utrecht, Dutch HealthCare Authority, 2009.
6. Friele R. Evaluatie Wet MarktordeningGezondheidszorg [Evaluation Health CareMarket Regulation Act]. Den Haag:ZonMw, 2009.
7. Vektis. Zorgthermometer 2010: Verzek-erden in beweging [Care thermometer2010: insured mobility]. Zeist: Vektis, 2010.
8. de Jong J, van den Brink-Muinen A,Groenewegen. The Dutch health insurancereform: switching between insurers, a com-parison between the general population andthe chronically ill and disabled. BMCHealth Services Research 2008;8:58.
9. Vos L, de Jong J. Percentage overstappersvan zorgverzekeraar 3%. Ouderen wisselen nauwelijks van zorgverzekeraar[Percentage of switchers of health insurerscompany 3%. Elderly hardly change between health insurers]. Utrecht, Netherlands Institute for Health ServicesResearch (NIVEL), 2009.
10. Van de Ven W, Schut F, Hermans H, etal. Evaluatie Zorgverzekeringswet en Wetop de zorgtoeslag [Evaluation Health Insurance Act and Health Care AllowanceAct]. Den Haag: ZonMw, 2009.
11. Verbrugh H. De zorginkoper bij uitstek[The pre-eminent health care purchaser]Medisch Contact 2008;63(18):772–75.
HEALTH POLICY DEVELOPMENTS
Eurohealth Vol 16 No 427
HEALTH POLICY DEVELOPMENTS
The Dutch health care system tends to dovery well in international comparisons;patient organisations have a strongposition, and health services are justaround the corner and easily accessible forall. The Netherlands is, without doubt, arelatively wealthy and healthy nation, butis it really a patients’ paradise? The DutchHealth Care Performance Report 20101
confirms many of the Dutch achievements,but it also reveals some urgent challengesfor Dutch health care.
To monitor trends in health care per-formance, the Dutch Ministry of Healthhas commissioned RIVM to produce theDutch Health Care Performance Report(DHCPR) every two years. Using a set of125 indicators, the DHCPR 2010, pub-lished in English in November 2010,assessed the quality, accessibility and costsof the Dutch health care system by com-paring performance with standards, with
previous years and with other countries.
The conceptual framework used for theDHCPR is based on an extensive interna-tional literature review.2,3 In the appliedframework, health care is divided into fourspecific health care needs: staying healthy(prevention), getting better (cure), livingindependently with a chronic illness or dis-ability (long-term care), and end-of-lifecare. The indicator framework used is wellaccepted internationally. The Organisationfor Economic Co-operation and Devel-opment (OECD) has adopted thisframework for the further development ofinternational comparisons of health caresystem performance.4 Results of the pre-vious DHCPRs were also used in therecently published Health System Reviewof the Netherlands.5 To fill the indicators,RIVM used 68 different national and inter-national data sources from 30 differentorganisations.
How is the Dutch health care system per-forming?What does the DHCPR 2010 teach usabout the Dutch health care system? Wewill discuss some of the major challengesand the successes of Dutch health care thatstand out in the report.
Easy access; health care for all
Overall, we concluded that the Nether-lands provides excellent access to healthservices. Following the definition of Smitsand colleagues,6 accessible care implies that‘people, who need care, can access care ina timely manner and without great bar-riers’. The Netherlands has a very intricatenetwork of health services. Geographicalanalyses show that the average driving timefrom home to the nearest general practi-tioner (GP), physiotherapist or pharmacyis 1.3 minutes. For hospitals this is 7.7minutes. Hardly anyone has to drive morethan fifteen minutes to reach any of theseservices.
Costs of care seldom pose a problem.Under a mandatory health insurancescheme practically all residents are insuredfor curative health care costs. Most long-term care services are paid for by a socialinsurance scheme that covers all Dutch res-idents. Co-payments are amongst the
Health care performance in theNetherlands: Easy access, varying quality, rising costs
Michael van den Berg, Richard Heijink, Laurens Zwakhals, Harry Verkleijand Gert Westert
Summary: To monitor trends in health care performance, the Dutch Ministry ofHealth has commissioned the Dutch National Institute for Public Health and theEnvironment (RIVM) to produce the Dutch Health Care Performance Report(DHCPR) every two years. Using a set of 125 indicators, the DHCPR 2010 assessedthe quality, accessibility and costs of the Dutch health care system by comparing per-formance with standards, with previous years and with other countries. The reportconfirms many of the Dutch achievements reported in international comparisons, butalso reveals some urgent challenges for Dutch health care.
Keywords: performance assessment, the Netherlands
Michael van den Berg, Laurens Zwakhals and Harry Verkleij are researchers at the Na-tional Institute for Public Health and the Environment (RIVM), Bilthoven.
Richard Heijink is a researcher at the University of Tilburg and RIVM.
Gert Westert was project leader of the Dutch Health Care Performance Report 2010, re-searcher at RIVM and professor at the University of Tilburg, since January 2011 he hasbeen Head of IQ-healthcare and professor at Radboud University, Nijmegen.
Email: [email protected]
lowest in the OECD countries. In com-parison with six other affluent countries,the Netherlands reported the smallest per-centage of residents (1%) and people withchronic illnesses (3%) who forego visits tothe doctor for financial reasons.
Still, it appears that this easy access mightbe under threat in some areas. Waitingtimes for certain health services have beena persistent problem in the Netherlands.For 25% to 33% of clients receivingmental health care, waiting times fortreatment were longer than the agreedstandard. Likewise, waiting times in out-patient clinics and long-term care oftenexceeded the standard. Poor telephoneaccess to GP practices during office hourswas reported as a problem by many peopleand one third of emergency calls to GPpractices were not answered within thethirty-second standard.
Quality of care stands out in many ways,but varies between providers
Nine out of ten citizens evaluated healthcare positively. More than 90% were sat-isfied with the interaction betweenthemselves and their health care providers.Moreover, outcome indicators show pos-itive figures and trends: hospital mortalityrates have been decreasing for five years ina row, while infant mortality has decreasedby some 20% since 2005. Survival rates forcancer are high by international com-parison and there are only a few avoidablehospital admissions compared with othercountries. The latter is due to a strongdeveloped primary care system and out-patient clinical care.
A typical characteristic of Dutch healthcare is a somewhat reserved approachtowards medical interventions. Thisresults, for example, in low referral andadmission rates, low prescription of antibi-otics, and low numbers of revascular-isations and caesarean sections comparedto most other countries.
Although the overall level of curative careis acceptable for many treatments, it makesquite a difference where the treatmenttakes place. A number of indicators showwide variations between health careproviders:
– the percentage of prescriptions by GPsin accordance with guidelines variedfrom 49% to 77%;
– the percentage of hip fracture patientsoperated on within 24 hours rangedfrom 67.5% to 100% across hospitals;
– the percentage of caesarean sections inlow risk pregnant women varied widelybetween hospitals, ranging from 7% to30%;
– for a number of conditions treated inmental health care, drop-out ratesranged from less than 5% to 28%.
These findings appear to confirm theimportance of a best practice approach andof the use of benchmark or reflective infor-mation for health care providers.Moreover, patients and health insurersneed such information to make informedchoices on the health care market.However, suitable information aboutquality of care, and patient outcomes inparticular, is still lacking.
Long-term care is under pressure. Thedemand for care is growing and intensi-fying and becoming increasingly complex.Meanwhile, qualified staff are hard to find.There is also criticism about the quality ofcare, from both the consumers andproviders of long-term care. Just one thirdof the representatives of psychogeriatricpatients state that physical care is always ofgood quality. Nurses and carers in nursinghomes are not always positive about thequality of care; a significant number con-sider that it is below standard.
The problems in long-term care are takenseriously in the field, as well as in politics.In recent years health care professionals,patient organisations and the governmenthave worked hard to improve the measur-ability of the quality of long-term care. AnEvaluation Framework for ResponsibleCare has been developed. Institutions usethis framework as a tool to account for thequality of care they provide. Thisframework was described previously inEurohealth by Frijters.7 The new Dutchgovernment has now announced that theywill invest an extra billion euro in long-term care, particularly in care for olderpeople. Such an investment at a time ofhuge cutbacks in public spending indicatesthat there really is a sense of urgency toimprove this sector.
Costs: do we get value for money?In the period 2007–2009, health careexpenditures grew at an annual rate of 6%to 7%, which is slightly more than in pre-ceding years. The most recent OECDtime-series data (2000–2007) show that thegrowth in Dutch real health expenditurewas about average compared to otherOECD countries. Health spending growthresulted largely from an increase in the
volume of care – that is, more services weredelivered. Since 2002, the volume of careprovided by Dutch hospitals has grown by4.2% per annum compared to an averageprice rise of 1.6%. Inpatient admissionsgrew by 3% yearly and day-patient admis-sions by 10%. At the same time, thevolume of Dutch hospital care hasremained relatively low by internationalstandards. Interestingly, the price of medi-cines has fallen dramatically in recentyears, but the volume of medication pre-scribed (the number of prescriptions filled)increased in 2008 by almost 15%. Thevolume of outpatient care grew substan-tially in different areas: by yearly averagesof 5.5% in care for older people, by 8% peryear in mental health care and by anaverage of 9% per year since 2004 in carefor the disabled.
These growth figures may turn out to becritical from the perspective of publicfinances. Since 1990 the share of health carein total public expenditure has doubled(now being 20%) and health care has con-sumed a considerable part of nationalincome growth. The question is whetherthis seemingly autonomous growth in thehealth care sector can be maintained incomparison with growth in other sectors,and whether it will affect the purchasingpower of Dutch residents. The recent eco-nomic crisis and deterioration of publicfinances have rekindled the debate onhealth care spending.
High and rising health care costs may beless of a problem as long as investmentspay off. Moreover, the removal of anywaste or inefficiency in the health caresystem would alter health spending levelswithout adverse effects on quality andaccessibility of care. Efficiency analyses ofthe relationship between costs and qualityshow that despite rising costs, overall mor-tality and avoidable mortality havedropped significantly since 2003. The sameis true for most other western Europeancountries. In international macro levelcost-benefit comparisons, the Netherlandsperforms about average. Meso level indi-cators demonstrate signs of inefficiency,for example, the substantial variation infreely negotiable hospital prices, in theaverage length of hospital stays, in GPtariffs and in GPs prescribing cheapergeneric drugs.
Final remarksThe Netherlands is facing the same healthcare challenges as many other Europeancountries. How to control rising costs?
Eurohealth Vol 16 No 4 28
HEALTH POLICY DEVELOPMENTS
How can the system cope with an ageingof the population? How can it rise to thechallenges of scarcity in human andfinancial resources, as well as to the risingnumbers of the chronically ill? TheNetherlands has chosen to adopt a systemof managed competition with a range ofmeasures that aim to protect citizensagainst undesired side effects of marketforces (see the article of Van Ginneken etal in this issue) [8]. Health insurers andhealth care suppliers are primarilyaccountable for good quality care. Minis-terial accountability concerns thefunctioning of the health care system at amacro level and ‘the rules of the game’. TheDHCPR helps the minister to carry outthis role, by providing a monitoringinstrument on all aspects of care.
It is still too early to draw firm conclusionsregarding the successes or failures ofreforms in the system. Nevertheless, it goeswithout saying that in a system of managedcompetition in which market forces playan increasingly important role, policymakers are facing new challenges regardingquality, costs and access.
We end by highlighting three issues.
It is assumed that health insurers do notsimply purchase any health care service,but instead act as critical purchasers. In theDHCPR we concluded, however, thatinsurance companies mainly competed onthe price of health insurance policies andthe cost of health care services. In contrast,the quality of care is still of limitedinfluence in the purchasing process. Oneof the underlying problems is that qualityof care lacks transparency. Choice requiresclear and valid information aboutproviders. Several projects have started tocollect and publish such information, butthere is still a long way to go.
Easy access to health services is animportant achievement. However, theremight be a trade-off between access andquality. There is evidence that concen-tration of especially highly complexsurgery improves quality and reduces mor-tality rates. Critical purchasers of care arelooking for high quality providers and mayselectively contract with those providers.This means that many patients may not beable to visit their nearest hospital. Thesystem may have to make trade offsbetween access and quality. An interestingquestion is what differences in quality out-comes justify additional travelling time orwaiting lists.
The same is true for the trade off between
prices and access. Health insurers can offercheap policies that restrict freedom ofchoice. By contracting only a limitednumber of health care providers, healthinsurers are able to negotiate for cheapercare for many services. In this case patientssacrifice some access for cheaper insurance.Interesting questions will concern whetherinsurees will accept such restrictions andwhat impact this will have on equity andquality in the long term, given that pre-miums are rising. Another question will bewhether contracting changes the structurein health care markets (market power).
The DHCPR will continue to monitortrends in quality, accessibility and costs ofDutch health care. This information will beregularly updated at www.healthcareperformance.nl
REFERENCES
1. Westert GP, Van den Berg MJ, ZwakhalsSLN, De Jong JD, Verkleij H. DutchHealth Care Performance Report 2010.Bilthoven: National Institute for PublicHealth and the Environment (RIVM),2010. Available at: http://www.gezondheidszorgbalans.nl/object_binary/o10298_dhCPR2010.pdf
2. Arah OA. Performance reexamined.Concepts, Content and Practice of Measur-ing Health System Performance. Amster-dam: Universiteit van Amsterdam, 2005.Dissertation.
3. Arah OA, Westert GP, Hurst J, KlazingaNS. A conceptual framework for theOECD Health Care Quality IndicatorsProject. International Journal for Qualityin Health Care 2006;18:Suppl:5–13.
4. Organisation for Economic Co-opera-tion and Development. Health at a Glance2009. Paris: OECD, 2009.
5. Schäfer W, Kroneman M, Boerma W etal. The Netherlands: Health system review.Health Systems in Transition, 2010;12(1):1–229.
6. Smits JPJM, Droomers M, Westert GP.Sociaal-economische status en toeganke-lijkheid van zorg in Nederland [Socioeco-nomic status and the accessibility of care inthe Netherlands]. Bilthoven: RIVM, 2002.
7. Frijters DHM. Quality of care assurancein long-term care in the Netherlands. Euro-health 2010;2:11–13.
8. Van Ginneken E, Schäfer W, KronemanM. Managed competition in the Nether-lands: still work in progress. Eurohealth2010; 16(4):23–16.
Eurohealth Vol 16 No 429
HEALTH POLICY DEVELOPMENTS
New HiTs on Greece and Spain
GREECE
Charalambos Economou180 pages
Despite success in improving the health of the population, the Greek health caresystem faces serious structural problems concerning the organisation, financingand delivery of services. It suffers from the absence of cost-containment meas-ures and the high percentage of private expenditure goes against the principlesof fair financing and equity. Efficiency is also in question due to the lack of in-centives to improve performance in the public sector. In addition, the oversup-ply of physicians, the absence of a referral system and irrational pricing andreimbursement policies are the factors encouraging under-the-table paymentsand the black economy. These shortcomings result in low satisfaction with thehealth care system expressed by citizens.
SPAIN
Sandra García-Armesto, María Begoña Abadía-Taira, Antonio Durán, Cristina Hernández-Quevedo and Enrique Bernal-Delgado295 pages
The new Spain HiT focuses on the consequences of the totally devolved statusof the health system, consolidated in 2002, and the implementation of the roadmap established by the 2003 Spanish National Health System (SNS) Cohesionand Quality Act. The reforms have paved the way for a brand new consensus-based policy-making process grounded in knowledge management, the effectsof which are progressively starting to be evident.
Available online at www.healthobservatory.eu
Please contact Azusa Sato [email protected] to suggest web sites for
potential inclusion in future issues.
Eurohealth Vol 16 No 4 30
The European Public HealthLaw Network (EPHLN)
http://www.ephln.org/
Patient rights in the EU
http://europatientrights.eu/
Hungarian Presidency of theCouncil of the EuropeanUnion
http://www.eu2011.hu/
Founded in 2008 as a collaboration between the Centre for Biomedical Ethics and Law (Catholic Uni-versity of Leuven, Belgium) and EuroGentest (an EU funded initiative that deals with all aspects ofgenetic testing), this website provides a general overview of national patients rights legislation in allEuropean member states. Users are able to browse topics by country, whereupon more detailed infor-mation and further links are given. There is a section dedicated to the European Convention on HumanRights and Biomedicine. European ethical-legal papers linked to the university faculty are availablefor perusal, with direct web access to the University and EuroGentest provided. The site is availablein English only.
Medicines and Healthcareproducts Regulatory Agency(MHRA)
http://www.mhra.gov.uk/
The MHRA is an executive agency of the UK Department of Health. It is responsible for ensuringthat medicines and medical devices work and are acceptably safe. The website details the backgroundof MHRA and the site is divided between the ‘Pharmaceutical Industry’ and ‘Patients and public’,each with further links and perspectives. Individual sections are dedicated to regulation, safety, com-mittees, conferences and learning centre, online services and extra sources of information, includingpublications, a news centre and a portal for feedback. Many reports and publications are freely availableto download and users can sign up to an email alert. A search box, contact information, glossary andother user friendly tools allow for ease of access.
Eucomed
http://eucomed.org/
The Brussels based Eucomed represents 4500 designers, manufacturers and suppliers of medical tech-nology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Itsmission is to improve patient and clinician access to modern, innovative and reliable medical tech-nology. The website contains industry information, press releases, Eucomed’s code of ethics, patientstories and downloadable newsletters. Users can follow twitter feeds and subscribe to the newsletter,press releases and participate in Eucomed’s blog. Vacancies and contact details are also found online.A search box allows for easy navigation. The site is available in English only.
News and information on the Hungarian Presidency of the EU.
The EPHLN is a European Commission funded website which aims to disseminate resources relatedto public health law. In particular, EPHLN was set up as part of a Pandemic Influenza project,PHLawFlu, which looks at the use of law as a tool in promoting and protecting public health. Visitorsto the site are able to download publications, listings of past events and legislation. On the homepagenews and twitter feeds highlight relevant postings. In addition useful links, a search tool and a glossaryare accessible. Users may sign up to the EPHLN newsletter. The website is available in English andpartly in French.
The European Association of Health Law (EAHL)
http://www.eahl.eu
The European Association of Health Law was established in 2007 by a group of health lawyers in aca-demic institutions from around Europe to provide a forum for health lawyers from countries in theCouncil of Europe and beyond to discuss and collaborate on issues of importance in the developmentof health law and related policies. The website contains newsletters (published bi-annually), infor-mation on upcoming events, conferences, seminar series and other related events. The progress of threeworking groups – ‘Research and Networks’, ‘Institutions’, and ‘Teaching and training’ – can be trackedonline. Users may sign up for membership, whereupon a forum provides opportunities to interact indiscussions and the European Journal of Health Law becomes fully accessible. Contact informationis provided online. The site is available in English only.
WEBwatch
Eurohealth Vol 16 No 431
NEW PUBLICATIONSNEW PUBLICATIONSNEW PUBLICATIONS
Physical Activity in the Prevention andTreatment of Disease
Sweden: Professional Associations for Physical Activity, 2010
ISBN 978-91-7257-715-2
623 pages
Freely available online at:http://www.fhi.se/PageFiles/10682/Physical-Activity-Prevention-Treatment-Disease-webb.pdf
This extensive report outlines the roleof physical activity in the prevention andtreatment of disease. The authors of thiscompilation advocate regular exercise asa proven way to combat different dis-eases including diabetes, cardiovasculardisease, colon cancer and depression.Furthermore, the European Union Pub-lic Health Information System (EUPhix)estimates that physical inactivity costsbetween €150 and €300 per citizen peryear, while the medical costs of physicalinactivity in the United States alone wereestimated at $75 billion in 2000. The re-port also supports exercise to encouragethe active involvement of patients in theirown treatment and taking personal responsibility for their own health.
The document is split into two parts,with a total of 47 chapters written by 95experts. The first part provides a back-ground and scientific rationale for theargument, whilst the second lists the ben-efits by specific disease. Each chapter
outlines a summary, definition of the dis-ease, effects of physical activity, indica-tions, existing prescriptions, functioningmechanisms and tests, interaction effectsand contraindications, as well as risks associated with physical exercise.
The authors argue that the report can be used as a handbook by health careprofessionals when prescribing physicalactivity, in addition to serving as a text-book for health care workers.
Contents:
Preface
Background
Part 1: benefits and scientific rationaleof physical activity
Part 2: benefits by disease (33 types)
World Health Report – Health systems financing: the path to universal coverage
Geneva: World Health Organization, 2010
ISBN 978 92 4 156402
ISBN 978 92 4 068480 5 (electronic version)
106 pages
Freely available online at:http://www.who.int/whr/2010/en/index.html
As demand for universal coverage hasmoved higher up the political agenda,the member states of the World HealthOrganization have committed them-selves to achieving this goal by develop-ing their health financing systems. Inthis edition of the World Health Report,countries are advised on how to bestmove forward and sustain gains.
The report begins by outlining the current situation (that of generally lowuniversal coverage and high direct pay-ments by individuals) and continues tosummarise the role of government anddonor assistance in covering the costs.It is argued that prepayment and/orpooling are the best mechanisms, butgovernments must also support additional barriers to obtaining access tohealth care, such as transport and accom-modation costs. Furthermore, the incentives of all actors must be alignedto achieve optimal efficiency and equity.
In the final chapter, the report recom-mends seven key actions and emphasisesthe importance of the international community in aiding lower incomecountries to achieve universal coverageand improve health outcomes.
Contents:
Message from the Director General
Executive summary
Where are we now?
More money for health
Strength in numbers
More health for the money
An agenda for action
Index
Eurohealth aims to provide information on new publications that may be of interest to readers. Contact Azusa Sato at [email protected] if you wish to submit a publication for potential inclusion in a future issue.
NEWS FROM THE INSTITUTIONS
Health priorities under the Hungarian PresidencyHungary took over the six-monthrotating presidency of the EUCouncil of Ministers on 1 January.An Informal Health MinisterMeeting will take place inBudapest on the theme of sustain-ability and efficiency of healthsystems on 4 –5 April. Councilconclusions on the subject will beprepared on the basis of discus-sions in the ministerial meeting.
Other topics during the Hun-garian Presidency will include thethird action programme in thefield of health, as well as on healthprofessionals. A ministerial con-ference will be held as part of thee-Health Week on 10 –13 May inBudapest in order to show the keyrole of e-Health in modernisinghealth services.
The future of the EU PublicHealth programme will be dis-cussed and attention will also befocused on mental health andhealthier lifestyles for children andyoung people, as well as on injuryprevention and safety promotion.Mental health is a priority forHungary. The last of five confer-ences under the EU MentalHealth Pact has been held duringthe Hungarian Presidency andemphasises the role reconciliationof work and family life plays indemographic change. It will alsobe a topic for the Informal Minis-terial Meeting taking placebetween 31 March and 1 April2011. The debates during theinformal ministerial meeting willbe included in the conclusions onthe issue.
Further information athttp://www.eu2011.hu/
Directive on cross-border healthcare adoptedOn 28 February 2011, the Councilof the European Union approvedthe European Parliament’s amend-ments on a draft directive facilita-ting access to safe and high-qualitycross-border health care and promoting cooperation on healthcare between member states.
The European Parliament’samendments reflect a second-reading-compromise reachedbetween the Belgian Presidencyand representatives of theEuropean Parliament in aninformal trialogue on 15December 2010. In line withArticle 294 of the Lisbon Treatythe cross border health caredirective has now been adopted.Member states will have thirtymonths to transpose the directive’sprovision into national legislation.According to the European Com-mission, the current scale ofcross-border mobility amounts to1% (€10 billion) of overall EU-27public health spending (€1,000billion). The Commission esti-mates the cost increase under thenew rules will be just €30 milliona year.
The new directive provides clarityabout the rights of patients whoseek health care in anothermember state and supplements therights that patients already have atEU level through the legislationon the coordination of socialsecurity schemes (Regulation 883/04). It meets the Council’s wish tofully respect the case law of theEuropean Court of Justice onpatients’ rights in cross-borderhealth care while preservingmember states’ rights to organisetheir own health care systems.
More specifically, the newdirective as a general rule willallow patients to receive healthcare in another member state andbe reimbursed up to the level ofcosts that would have beenassumed by the member state ofaffiliation, if this health care hadbeen provided on its territory.Instead of reimbursing the patient,member states of affiliation mayalso decide to pay the health careprovider directly. However ifthere are overriding reasons ofgeneral interest (such as planningrequirements for ensuring per-manent access to a balanced rangeof high-quality treatment or thewish to control costs and to avoidany waste of resources) a memberstate of affiliation may limit theapplication of the rules on reim-bursement for cross-border health
care. Member states may alsointroduce a system of prior autho-risation to manage the possibleoutflow of patients, but this islimited to health care that issubject to planning requirements,such as hospital care (defined ascare involving overnight hospitalaccommodation) and health carethat involves highly specialisedand cost-intensive medical infra-structure or equipment, healthcare that involves treatments pre-senting a particular risk for thepatient or the population, orhealth care which would be pro-vided by a health care providerwhich could raise serious concernswith regard to the quality orsafety of the care.
Equally member states may alsoadopt measures concerning accessto treatment where this is justifiedby overriding reasons of generalinterest. Member states will alsohave to establish national contactpoints that must provide patientswith information about theirrights and entitlements and prac-tical aspects of receiving crossborder health care, for exampleinformation about health careproviders, quality and safety,accessibility of hospitals forpersons with disabilities, to enablepatients to make an informedchoice.
Cooperation between memberstates in the field of health care hasbeen strengthened, for example, inthe field of e-health and throughthe development of a Europeannetwork which will bringtogether, on a voluntary basis, thenational authorities responsiblefor e-health; another example israre diseases, where the Com-mission will have to supportmember states in cooperating inthe field of diagnosis andtreatment capacity.
The recognition of prescriptionsissued in another member state hasbeen improved; as a general rule, ifa product is authorised to be mar-keted on its territory, a memberstate must ensure that prescrip-tions issued for such a product inanother member state can be dis-pensed in its territory in compli-ance with its national legislation.
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The directive does not cover sales ofmedicinal products and medical devices viainternet, long-term care services providedin residential homes and the access andallocation of organs for the purpose oftransplantation.
More information at http://ec.europa.eu/health/cross_border_care/policy/index_en.htm
WHO European Member States plan forhealth in 2020Governments are facing new and difficultchallenges that affect the health of theirpopulations. It is time not only to coor-dinate a coherent response to the currentsituation but also to plan for the next tenyears, using the evidence on whichapproaches and solutions work best. Thisis the background to the development byWHO Europe of a new health policyframework for Europe called Health 2020.The first consultation on the process beganin Andorra from 9–11 March 2011.
Senior government officials representingthe 53 Member States came together todiscuss the vision, strategic goals, scope andcontent of Health 2020, and to share expe-riences and strategies in implementing theTallinn Charter, Health Systems for Healthand Wealth. This first meeting of theEuropean Health Policy Forum for High-Level Government Officials was hosted bythe Ministry of Health, Well-being andLabour of Andorra and opened byAndorran Prime Minister Jaume Bartumeu.
The Health 2020 framework will be builton the Health for All strategy and otherkey European health policy frameworksincluding the Tallinn Charter. An interimreport on the follow-up of the TallinnCharter commitments was discussed at themeeting. It highlights innovative examplesof actions by countries and WHO that areconsistent with the commitments of theTallinn Charter, especially in light of thefinancial crisis. It also emphasises the needfor a rejuvenated effort in public health,and explains how Health 2020 will furthermany of the key concepts put forward inthe Charter.
Health 2020 puts special emphasis on thekey role of ministers of health as advocatesand catalysts of action for health, bothwithin and beyond the boundaries of thehealth sector. Another positive devel-opment is the increasing involvement indecision-making of patients and citizens,who are no longer passive but, thanks to information technology, are more
empowered than ever before to take moreresponsibility for their health in a differentrelationship with the health system.
Member States have agreed that new andinnovative policies are needed to deal withthe pressing health issues in the EuropeanRegion in a comprehensive, cost-effectiveand coordinated way. These issues includethe epidemics of obesity, cancer and heartdisease; large differences in health statusand life expectancy; increasing mental dis-orders; re-emerging communicablediseases; and the need to plan for emer-gencies and pandemics. Action to addressthese issues has to take account of theimpact of factors such as globalisation,urbanisation, climate change, a largerageing population and the economic crisis.
“We want Health 2020 to mobilisedecision-makers everywhere,” said MsZsuzsanna Jakab, WHO Regional Directorfor Europe. “Governments’ engagementand early feedback are absolutely crucial,as we want this to be a fully participatorypolicy development process. It is the startof a determined effort to work together forthe health and well-being of the people ofEurope, both now and in the future, basedon the evidence on the causes of ill healthand good solutions that make economicsense. At the same time, we also continueour efforts to strengthen health systemsand invest more in health protection,disease prevention and health promotion.Europe is truly committed to strengtheninghealth systems and thus the follow-up tothe Tallinn Charter is a flagship project forWHO/Europe and the Division of HealthSystems and Public Health.”
WHO/Europe has also recently commis-sioned a number of studies that will informHealth 2020, including a European reviewof the social determinants of health and thehealth divide, led by Sir Michael Marmot,of University College London, UnitedKingdom; and a study on governance forhealth in the 21st century, led by ProfessorIlona Kickbusch, of the Graduate Instituteof International and Development Studies,Geneva, Switzerland. Other studies willaddress other key aspects of the Health2020 policy framework such as the eco-nomics of prevention and an anticipatoryanalysis of drivers of and trends affectinghealth.
More information on the first meeting ofthe European Health Policy Forum athttp://www.euro.who.int/en/home/conferences/first-meeting-of-the-european-health-policy-forum
EU Mental Health Pact Conference: Promotion of mental health and well-being in workplacesImproving mental health and well-being inthe workplace can have many benefits toemployers and employees, as well as to public health. This includes economicadvantages for businesses and socialsecurity systems. Healthy, productiveemployees make a vital contribution to acompany’s success and competitiveness,but psychological strain is increasing atworkplaces. For those who have experi-enced poor mental health, getting andkeeping a job can be vital to the recoveryprocess, boosting self esteem, confidenceand social inclusion. A high level of mentalhealth at work is essential for the imple-mentation of the Europe 2020 strategy,including the objective of higher rates ofemployment.
The conference Promotion of MentalHealth and Well-being in Workplaces,which opened in Berlin on 3 March, aimedto raise awareness of the relevance ofmental health and well-being for work-places. Organised by the EuropeanCommission and the German FederalMinistry of Health, in cooperation withthe German Federal Ministry of Labourand Social Affairs and with the support ofthe Hungarian EU Presidency, it broughttogether around 350 experts to discuss therole of workplaces in improving the mentalhealth and well-being of the population.
The case for action from a public healthperspective was the focus of the con-ference. The workplace constitutes a keyarea for health promotion and the pre-vention of mental disorders. Conferencesessions included the case for investing inmental well-being and practical steps forsocial security actors to build mentallyhealthy workplaces – in both corporateand public sector spheres.
Opening the conference, Stefan Kapferer,Secretary of State, German Federal Min-istry of Health stated that addressingmental health in the workplace is one ofthe key priorities of the German federalgovernment for preventative action.Having a healthy environment in theworkplace offers the opportunity to elim-inate risk factors for poor mental healthand promote the health of employees. Thechanging nature of work increases thedemands on many employees. He high-lighted the economic impact of poormental health, pointing out that it was oneof the major causes of absenteeism fromwork in Germany and other countries.
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In addition to an economic argument fortaking action, he also stated that there isalso a strong public health case for takingaction in the workplace. The costs of poormental health impact not just on indi-viduals themselves but also insurers andemployers The workplace is a settingwhere a large proportion of the adult population can be reached, given thatmany go to work on a regular basis. Politi-cians, he argued, must respond to theseissues and develop strategies to prevent theemergence of mental disorders.
Among the many conclusions of the con-ference it was acknowledged that mentalhealth is an important indicator of thequality of social cohesion and the qualityof work. It is also a core element ofEurope’s social model. Only a high degreeof mental health will allow Europe to meetits economic and social challenges, whilefurther advancing its aims of competi-tiveness and social cohesion. Moreover, theprotection and promotion of mental healthcan make a vital contribution to the imple-mentation of the European Union’s‘Europe 2020’ agenda with its objective ofsmart, sustainable and inclusive growth.This is especially necessary to achieve oneof the specific objectives of the agenda:raising the employment rate of the popu-lation, between the ages of 20 and 64 years,from the current level of 69% to at least75%.
The need for action is particularly pro-nounced in the case of small and mediumsized enterprises that are least likely toinvest in the promotion of mental healthand wellbeing at work. Actions by healthand social security agencies discussed at theconference included measures to providefinancial and non-financial incentives andsupport to companies to promote work-place mental health. Cooperation betweencompanies and social security organisa-tions is already being supported inGermany. €40 million per annum areinvested by health insurers in relevantoccupational health promotion tasks.
This was the fifth and final conferenceunder the European Pact for Health andWell-being, launched in 2008. This Pactprovides an EU framework enablingexchange and cooperation between stake-holders in different sectors, includinghealth, employment and education, on thechallenges and opportunities in promotingbetter mental health. Conferences on theother themes under the Pact – MentalHealth in Youth and Education, Prevention of Depression and Suicide,
Mental Health and Well-being in OlderPeople and Promoting Social Inclusion andCombating Stigma – were held in 2009 and2010.
Conference conclusions, a detailed background document, presentations andother information are available athttp://ec.europa.eu/health/mental_health/events/ev_20110303_en.htm
Workers’ and employers’ agreementhelping to deal with stress at workThe European Commission has publishedan evaluation of the 2004 social partnersagreement on work-related stress, con-cluding that it has had positive effectswhere implemented. Although theagreement has not been implementedevenly, nineteen countries now have legis-lation or binding collective agreements thataddress stress or other psychological risksat work.
Over the last ten years, work-related stresshas increased in nine EU countries and hasonly fallen in Sweden. Studies suggest thatbetween 50% and 60% of all lost workingdays are related to stress. In France forexample, the cost of stress has beenreported to reach at least €2 to €3 billioneach year. In the UK it is estimated that tenmillion working days are lost due toanxiety, stress and depression linked towork. The direct costs related to stress atwork are now estimated to be as high as4% of EU GDP.
In response to these developments, the2004 social partner agreement – concludedby all cross-industry European socialpartners (Business Europe, the EuropeanAssociation of Craft, Small and MediumSized Enterprises, the European Centre ofEmployers and Enterprises and theEuropean Trade Union Confederation) –aims to raise awareness of work-relatedstress and provide a framework for action.The role of employers is to identify riskfactors for stress and to try to matchresponsibility better with skills; consultworkers on restructuring and new tech-nologies; and to provide support toindividuals and teams.
The Commission’s evaluation of theagreement concludes that it has successfullytriggered social dialogue and policy devel-opments in the field of occupational stressin most EU countries. At the same time, theagreement has not been implementedevenly throughout Europe. Social partnersin Malta, Cyprus, Poland and Slovenia havenot reported on the follow-up to their
commitments, while results in Bulgaria, theCzech Republic, Germany and Estoniahave fallen short of expectations.
The report can be viewed at http://ec.europa.eu/social/BlobServlet?docId=6560&langId=en
MEPs approve laws to curb counterfeitdrugsA new law to prevent fake medicines fromentering the legal supply chain wasapproved by Parliament on 16 February.Internet sales will be covered by the law,which also introduces new safety andtraceability measures, as well as sanctionsagainst counterfeiters. This law still needsto be formally approved by the Council ofMinisters.
“Falsified medicines are silent killers, eitherbecause they are devoid of effect orbecause they contain toxic substances thatmay harm, or even kill, those who takethem. The absence of a legal frameworkencourages counterfeiting, an organisedcrime. We have been witnessing a hugegrowth of this criminal activity, with anincrease of 400% in seizures of fake drugssince 2005. Protecting patient safety is thecore aim of this directive”, said PortugueseMEP Marisa Matias, who led discussionsin Parliament. The resolution was adoptedwith 569 votes in favour, 12 against and 7abstentions.
It is estimated that 1% of medicinalproducts currently sold to the Europeanpublic through the legal supply chain arecounterfeit and the share is growing. Therewere more than eleven million counterfeitmedicines seized at EU borders in 2009, afourfold increase in just three years,according to a report on EU customsenforcement. In other parts of the world,up to 30% of the medicines on sale may befake. In particular, more and more inno-vative and life-saving drugs are counterfeit.
MEPs also deemed it necessary to regulateinternet sales of medicines because this is akey route by which fake products enter theEU market. The Commission’s originalproposal did not cover internet sales.Under the new law, in those EU MemberStates where internet pharmacies areallowed to operate, they will need to beauthorised to supply pharmaceuticals tothe public.
Currently, six EU members allow patientsto buy prescriptions online: Denmark,Germany, the Netherlands, Portugal,Sweden and the United Kingdom. Underthe new laws, pharmacies that comply with
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the rules will have an EU logo on theirwebsites. Under the rules, the chief phar-macist must be identified on the websitesfor all mail-order pharmacies, and thedoctor’s original prescription must beobtained before mailing out the medicine.
Internet pharmacy sites will be required todisplay a common logo, which should berecognisable throughout the EU, so as tohelp the public to ascertain that they arelinked to an authorised pharmacy. Allauthorised internet pharmacies will belinked to a central web site in each memberstate and will be listed on that web site. Thevarious national web sites will in turn belinked to an EU web site. Citizens will alsohave to been informed about the risksinvolved in buying medicines via theinternet.
The legislation updates current rules andprovides for new safety features to beplaced on individual packs in order toidentify them, guarantee their authenticity,and enable pharmacists to check whetherthe outer packaging has been tamperedwith. These safety features – which stillneed to be developed by the EuropeanCommission – could, for example, includea serialisation number which can be ‘read’by the pharmacy to ascertain that the packis authentic.
As a general rule these features wouldapply to all prescription medicines, unlessthere is clearly no risk. They would applyto non-prescription medicines only inexceptional cases, where there is a risk offalsification. Where medicines arerepackaged, these safety features must bereplaced by equivalent ones.
The text approved by MEPs results from anagreement reached with Council, whichmust also give its formal approval. TheCommission have estimated the cost of thislegislation would be between €6 billionand €11 billion, the bulk of which wouldfall on the industry. Consumer advocatesare also concerned about data privacy. Withserial tracking numbers, a lot of sensitivehealth information will be stored inpharmacy databases and shared acrossnational borders. Once it is signed into law,Member States have eighteen months tomake any necessary changes to theirnational legislation.
More information under texts publishedon 16 February at http://www.europarl.europa.eu/activities/plenary/ta/calendar.do?language=EN#
World Cancer Day – WHO stresses importance of physical activity for cancerpreventionOn World Cancer Day (4 February 2011),the world’s cancer control community pro-moted preventive measures that can reducethe burden of cancer and potentially savemillions of lives. This year’s event was alsoan important milestone in the preparationsfor the United Nations high-level meetingon the prevention and control of Noncom-municable Diseases (NCDs), to be held inNew York on 19–20 September 2011. The high-level meeting will be a historic opportunity to secure renewed global com-mitment to tackling cancer, cardiovasculardiseases, chronic respiratory diseases anddiabetes, and to push for the implementa-tion of the WHO Global Strategy for thePrevention and Control of NCDs and itsAction Plan for 2008–2013. In addition,health ministers and other stakeholders willgather in Moscow, Russian Federation, on28–29 April 2011 for the first global min-isterial conference on healthy lifestyles andNCD control.
Meantime, on 2 February 2011, in a newset of global recommendations on physicalactivity for health, the WHO has set outguidance to governments on the dose–re-sponse relationship between the frequency,duration, intensity, type and total amountof physical activity needed to preventNCDs in various age groups.
Levels of physical inactivity are rising inmany countries in the world, with majorimplications for people’s general health andthe prevalence of NCDs (such as cardio-vascular disease, diabetes and cancer) andtheir risk factors (such as high blood pres-sure and blood sugar, and overweight).Physical inactivity is estimated to be theprimary cause of about 21–25% of breastand colon cancer cases, 27% of diabetes and30% of ischaemic heart disease in the world.In the 53 countries in the WHO EuropeanRegion, NCDs cause 86% of deaths.
“These diseases are largely preventablethrough effective interventions that tacklefour common risk factors: tobacco use, un-healthy diet, physical inactivity and theharmful use of alcohol,” commented DrGauden Galea, Director of the Division ofNoncommunicable Diseases and HealthPromotion at the WHO Regional Officefor Europe.
The global recommendations are avail-able at http://www.who.int/dietphysicalactivity/factsheet_recommendations/en/index.html
COUNTRY NEWS
England: major reforms proposed forNational Health ServiceOn 19 January 2011, extensive legislationto reform the National Health Service(NHS) in England was laid before the UKparliament. The 367 page draft Bill pro-poses to introduce some of the mostsweeping reforms of the NHS in its 63 yearhistory. Key proposals include the abo-lition of Primary Care Trusts (PCTs) andStrategic Health Authorities (SHAs), to bereplaced by regional general practitioner(GP) commissioning consortia to controlapproximately 80% of the NHS budget forEngland (around £80 billion) by 2013. Thebill indicated that these commissioningconsortia could enter into commercial con-tracts with ‘any willing provider’ for allhealth services and will set terms and con-ditions of staff.
English Minister of Health, AndrewLansley, introducing the bill to Parliament,said it would create “dramatic opportu-nities” to improve the delivery of care,whilst reducing the “£5.3 billion of admin-istration costs”, and that the government’sintention “is to produce health outcomesthat are at least as good as anything foundelsewhere in the world”.
A new patients’ organisation calledHealthWatch and Health and WellbeingBoards will be established, to scrutiniselocal plans and implementation of thereforms. The previously independent NHSbody Monitor will be turned into an eco-nomic regulator with responsibilities fortariff price setting and for licensing trustswith the Care Quality Commission. It willbe able to challenge NHS staff pensionarrangements on the basis of an ‘unlevel’playing field between the NHS and privateprovider. In turn, Monitor may be‘directed’ by the Health Secretary where itis deemed to have committed a ‘seriousfailure’ to carry out its functions. WhereMonitor fails to follow the ‘direction’, theSecretary could override it. The Secretaryalready has similar powers over the CareQuality Commission but has said thatthese reforms will limit his power moregenerally and, according to Department ofHealth notes accompanying the Bill, thereforms will actually end health secretaries’“general power of direction” over theNHS.
An NHS Commissioning Board, to beheaded up by current NHS chief executiveSir David Nicholson, will take over the
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day-to-day running of the NHS by April2011, with wide-ranging powers todetermine the structure and shape of GPconsortia, including the power to removeor reduce GP consortia’s functions, bailthem out, or abolish a consortium alto-gether if it is perceived to be under-performing.
In such an event and, more commonly,where consortia are unable or unwilling toprovide commissioning services, the Billallows private health care firms to step into fulfil those services. This aspect of thedraft legislation, which represents a hugeopportunity for both UK and overseasprivate health care providers, is one of themost controversial aspects of the entireBill, and has led to claims that the coalitiongovernment is seeking to privatise theNHS without being fully open about itsaims. In particular, the proposed legislationwould have allowed competition to beforced on commissioners, even when theybelieve the best and most appropriateservices can be provided by local hos-pitals.”
The bill has faced opposition from someLiberal Democrat and Conservative back-benchers within the Coalition, as well ascriticism from health professional bodiesand independent think tanks. The BritishMedical Association has called the reformsa “massive gamble” likely to “damage localservices” and warned that although it sup-ports the greater involvement of cliniciansin planning NHS services, it believes these“benefits... are threatened by other parts ofthe Bill. Meantime, writing in the BritishMedical Journal on 22 March, academicsAllyson Pollock and David Price called fora large number of amendments to be tabledto legislation to “ensure continuation ofNHS comprehensive care”. They arguethat the original legislation removes theHealth Minister’s duty of care to provideor secure comprehensive health careservices, with no transfer of this duty to thelocal commissioning boards. They also callfor a removal of a clause in legislationwhich would allow local commissioningboards more scope for charging for healthcare services.
The government has made some conces-sions, ruling out price competition and the‘cherry-picking’ of services by privateproviders, and is open to the possibility offurther concessions to get the Bill passedinto law. The draft Bill also introduces newrequirements for the National Institute forHealth and Clinical Excellence (NICE) toconsider social care costs and the “desir-
ability of promoting innovation” whenassessing a drug’s cost effectiveness. Theseconsiderations have not previously beenpart of NICE’s criteria for analysing newproducts, but were recently used in itsOctober 2010 recommendations onincreasing the use of drugs in the NHS forthe treatment of Alzheimer’s disease, andare in accordance with the government’scurrent consideration of introducing a newvalue-based approach to the pricing ofbranded medicines.
An impact assessment for the Bill has alsobeen published. This predicts the reformswill cost up to £1.5 billion, mainly due toredundancy costs at PCTs and SHAs (theaverage redundancy cost per manager isexpected to be £48,000), but that byreducing the cost of commissioning acrossthe health service, the reforms could bringsavings of up to £8.8 billion. However, theanticipated cost savings for managementmay fail to materialise if the GP consortiaare too small to achieve the requiredeconomies of scale.
Progress on the Health and Social CareBill 2011 can be viewed at http://services.parliament.uk/bills/2010-11/healthandsocialcare.html
The commentary by Allyson Pollock andDavid Price is available athttp://www.bmj.com/content/342/bmj.d1695
Commission asks Italy to end discrimina-tion against doctors with experience andqualifications from other Member StatesThe European Commission has requestedItaly to take professional experience andseniority acquired by doctors in anotherMember State into account when deter-mining their rank or working conditions(like salary, grade career development) inthe Italian public sector. The Commissionconsiders that the current rules are dis-criminatory since they affect primarilyworkers of other Member States. TheCommission’s request (along with a similarrequest in respect of teachers) takes theform of a ‘reasoned opinion’ under EUinfringement procedures. Italy has twomonths to bring its legislation in both areasinto line with EU law. Otherwise, theCommission may decide to refer Italy tothe EU’s Court of Justice.
According to EU law, free movement ofworkers does not apply to employment inthe public sector so access to the publicservice can be restricted to nationals of thehost Member State. However, this dero-
gation has been interpreted in a veryrestrictive way by the Court of Justice ofthe EU and only posts that involve publicauthority and the responsibility for safe-guarding the general interest of the Statecan be restricted to their own nationals.The restriction therefore neither applies todoctors working in the public health insti-tutions, nor teachers working in the publiceducation institutions.
In line with the case law of the Court, pre-vious periods of comparable employmentacquired in the health sector of otherMember States must be taken into accountby the Italian health services when deter-mining professional benefits (for example,salary, career development), just as expe-rience acquired in the Italian system isconsidered. This specific Italian conditionthat requires continuity in work experiencein establishing a doctor’s rank constitutesan indirect discrimination of migrantworkers in determining their working con-ditions for posts in the Italian public sector.Migrant workers usually put an end toemployment in the Member States oforigin to move to another Member Statewith their move typically resulting in acareer break.
For more information on the infringementprocedures: http://ec.europa.eu/eu_law/infringements/infringements_en.htm
For more information on EU infringe-ment procedures, see MEMO/11/86
Early assessment of the deregulation inthe Swedish pharmacy market On 1 July 2009, the Swedish pharmacymarket was opened up for parties otherthan the Swedish state-owned ApoteketAB to conduct retail operations for bothprescription and non-prescription pharma-ceuticals. The purpose of this deregulationwas to provide consumers with increasedaccessibility, improved services andreduced costs for pharmaceuticals. In asecond phase of the deregulation of theSwedish pharmacy market, the marketingand sale of non-prescription pharmaceu-ticals in sale outlets other than pharmacies,such as supermarkets and petrol stationswas permitted from November 2009. Theprices for prescription pharmaceuticals arestill regulated but non-prescription phar-maceuticals are subject to market prices.
The Swedish National Audit Office (Rik-srevisionen, SNAO), which is responsiblefor auditing the activities of the entireSwedish state, has now reviewed thepreparatory work for the deregulation. It
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has identified several problems in thederegulation process, which have made itdifficult for operators (particularly smallindependent operators) to enter thepharmacy market and thus may restrictcompetition.
One such example is the requirement forpharmacy operators to obtain priorapproval of their IT system from ApoteketService AB in order to be permitted toestablish a pharmacy in Sweden. TheSNAO is critical of the fact that it is notpossible to appeal against ApoteketService’s decisions in this regard and thatApoteket Service has no obligation tocomply with general Swedish adminis-trative law principles, although it exercisesofficial authority in this way. It has recom-mended that the government restricts andclarifies the extent of Apoteket Service’ssupervisory role. It has also been critical ofthe pricing model for the process of ITsystem approval, stating that it may dis-criminate against small independentpharmacy operators due to the high costsof such IT systems.
Despite these limitations many newentrants to the pharmacy market canhowever be seen, with more than 200 newpharmacies having opened. There are nowfour dominant market operators (ApoteketHjärtat, the state-owned Apoteket,Medstop and Kronans Droghandel). TheBritish company Alliance Boots also plansto open at least 100 Boots-branded phar-macies in a joint venture withFarmacevtföretagarna AB, a companyowned by the Swedish PharmaceuticalAssociation. Many pharmacies have beenestablished in locations where previouslynone existed and opening hours haveincreased (before the deregulation, therewas only one 24-hour pharmacy inSweden).
A large number of retail stores have alsobegun to sell non-prescription pharmaceu-ticals.
England: changes to the regulation of unlicensed herbal medicines Under the European Directive on theCommunity Code Relating to MedicinalProducts for Human Use (2001/83/EC),from 30 April 2011 it will be illegal forpractitioners to supply unlicensed herbalmedicines. On 16 February 2011, the UKhealth minister Andrew Lansley stated thatpractitioners may continue to supply unli-censed herbal medicines if they registerwith the Health Professions Council(HPC).
In announcing the creation of the HPCregister process, the government isintending to make use of the derogation inArticle 5(1) of the Directive, which allowsnational arrangements to permit ‘autho-rised health care professionals’ tocommission unlicensed medicines to meetthe special needs of their patients. The ideais to create a scheme enabling practitionerswho are listed on the Register (‘RegisteredPractitioners’) to order unlicensed herbalmedicines to meet the special needs of theirpatients.
The creation of the Register will also affectSection 12(1) of the Medicines Act 1968.Under this provision, practitioners mayprepare unlicensed herbal medicines ontheir own premises for use following con-sultation with individual patients. Once theRegister is created, only Registered Practi-tioners will be able to rely on Section 12(1)of the Medicines Act 1968.
A formal consultation exercise run by theMedicines and Health Care products Reg-ulatory Agency (MHRA) is to take placeon specific legislative proposals for estab-lishing the Register and proposed reformsof medicines legislation by 2012.
The Health Secretary’s announcement hasreceived a mixed reception. As reported inThe Telegraph, Desiree Shelley, presidentof the National Institute of MedicalHerbalists, has congratulated the gov-ernment on “making the right decision”. Incontrast, Professor David Colquhoun, apharmacologist at University CollegeLondon, said the plans ran contrary tomainstream scientific thinking, by allowingherbalists to sell treatments that had notbeen rigorously tested, in contrast to theclinical trials procedure faced by pharma-ceutical companies. He also felt that herbalpractitioners “should not have been giventhe badge of governmental approval thatstate regulation confers on them.” Simi-larly, Sir Richard Thompson, president ofthe Royal College of Physicians hasexpressed his disappointment to hear of theplans, stating that “the proposed registerwill imply herbal therapies have the samelegitimacy as medicine, nursing and den-tistry, despite offering patients no provenbenefit.”
Ireland: new government committed touniversal health insurance by 2016Incoming Minister for Health in the newFine Gael and Labour Party Coalitiongovernment in Ireland, Dr James Reilly,has reaffirmed the government’s com-mitment to introducing a universal health
insurance system within the lifetime of thefirst term of the government (by 2016).The government has also promised tostrengthen the primary care system andintroduce free primary care for all, in con-trast to the current situation where morethan two-thirds of the population have topay a fee to consult with a general practi-tioner (GP). Speaking to irishhealth.comthe Minister, who is a former President ofthe Irish Medical Organisation, stated thatfree GP care would be funded from savingsfrom the Health Service Executive (HSE),which the new Programme for Gov-ernment states will “cease to exist overtime, with its functions returning to theMinister for Health and the Department ofHealth and Children; or be taken over bythe Universal Health Insurance system”.The system will be introduced in phases sothat additional doctors, nurses and otherstaff can be recruited. GPs will be paid pri-marily by capitation for the care of theirpatients and will work in primary careteams with other primary care profes-sionals.
The Programme for Government statesthat the Universal Health Insurance system“will be designed according to theEuropean principle of social solidarity:access will be according to need andpayment will be according to ability to pay.The principle of social solidarity willunderpin all relevant legislation.” Fur-thermore “as a statutory system of healthinsurance, guaranteed by the State, theUniversal Health Insurance system willnot be subject to European or nationalcompetition law.” The coalition agreementalso states that, “insurance with a public orprivate insurer will be compulsory withinsurance payments related to ability topay. The State will pay insurance premiafor people on low incomes and subsidisepremia for people on middle incomes.Everyone will have a choice between com-peting insurers.” The largest insurer theVHI will be kept “within public own-ership to retain a public option in theUniversal Health Insurance system.”
The Minister refused however to be drawnon how the proposed universal healthinsurance system would be funded, sayingthat it was far too early to comment withthe new system still at the planning stage.
The new government are also committedto introducing a system of risk equalisationfor the current health insurance market.Among other objectives, the embedding ofmental health services within primary carewas highlighted as one priority. Ring-
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fenced funding will be provided to recruitadditional psychologists and counsellors tocommunity mental health teams, workingclosely with primary care teams to ensureearly intervention, reduce the stigma asso-ciated with mental illness and detect andtreat people who are at risk of suicide.Another pledge is to change the organdonation to an opt-out system for organtransplantation, rather than an opt insystem so as to improve the availability oforgans for patients in desperate need.
The programme for government, includ-ing full plans on health, can be accessed athttp://www.taoiseach.gov.ie/eng/Publications/Publications_2011/Programme_for_Government_2011.pdf
Similar shortcomings in Nordic countriesfollowing mental health care reformsIn Denmark, Norway, Finland and Swedenreforms within psychiatry have trans-formed inpatient care to the point where ithas increasingly been replaced by outpa-tient care. The different countries haveapplied different solutions when reformingtheir mental health care systems, yetcertain shortcomings such as complexservice systems in which patients end up ina state of limbo and where cooperationamong staff becomes difficult, can befound in all four countries. It is thus notpossible to speak of a common Nordicwelfare model within this area.
The first evaluation of the mental healthcare reforms in the Nordic countries gen-erally shows that inpatient admission rateshave greatly decreased and that the use ofantipsychotic drugs has increased. It is acomplex and slightly ambivalent picturethat is being painted; as the Nordic mentalhealth care reforms proceed they face thedilemma of optimising the selection oftreatments and social services, as well asproviding users with greater influencewhen it comes to the contents of care.
Professor Rafael Lindqvist and his researchcolleagues are responsible for a compar-ative analysis where results of the mentalhealth care reforms in Denmark, Finland,Norway and Sweden are presented. Theresults show that the transition from amental health care system where mostservice users are given treatment at oneinstitution to outpatient care practicesresults in a number of deficiencies.
In spite of similar intentions, variations inservice structure and work modes are sig-nificant in the four countries. This is truealso when it comes to the service users. The
number of inpatient beds has been greatlyreduced in all countries but in otheraspects, the results differ. For instance,when it comes to antipsychotic drug con-sumption, Finland is at the top whileNorway is at the bottom. In Sweden acces-sibility to both inpatient and outpatientcare is lacking. Furthermore, the most vul-nerable sections of the population varybetween the different countries.
The report highlights the commonproblem of how to make the role ofprimary care clear and effective in the care-and support system; both in relation toinpatient psychiatric care services andsocial services. There has been no realdevelopment in user influence followingthe mental health care reforms. It is alsoobvious that equality in care is difficult torealise, especially in sparsely populatedareas. The current challenge is to promotea change in attitudes and counteract stig-matisation and discrimination.
The report will be presented during a sym-posium at the Nordic School of PublicHealth (NHV) on 12 April 2011. The sym-posium will conclude with a paneldiscussion among decision-makers fromthe Nordic countries.
The report can be ordered (in Swedish) bycontacting the Nordic School of PublicHealth from [email protected]
Belgium: new code of ethics regardingthe medical device industry’s interactionswith health care professionalsThe Belgian Association for producers anddistributors of medical devices (Unamec)has established a new Code of Ethics,which came into force on 1 January 2011.Unamec members recognise thatadherence to ethical standards and com-pliance with applicable laws is critical tothe medical devices industry's ability tocontinue its collaboration with health careprofessionals. The Code of Ethics sets thestandards appropriate to various types ofrelationships between the medical deviceindustry and health care professionals,based upon the principles of separation,transparency, equivalence and documen-tation.
The Code has two main parts. First, thebasic rules are set, including rules gov-erning verbal and written communications,the provision of sample products, the pro-vision of equipment, arrangements aroundscientific events, sponsorship arrange-ments, consultancy agreements, gifts,charitable donations and educational
grants. The second part relates to scientificstudies.
The new Code is based upon the EucomedCode of Ethical Business Practice – Guide-lines on Interactions with HealthcareProfessionals, and now complies with therequirements of article 10 of the BelgianMedicines Act of 25 March 1964 regarding,notably, the Mdeon visa requirement.
Unamec's Code of Ethics is available (inDutch and French) at:http://www.unamec.be
France: reform promised after diabetesdrug scandalFrench Health Minister Xavier Bertrandhas promised a complete overhaul of thecountry’s medical regulatory system. Hewas speaking after an official independent260-page report by the InspectionGénérale des Affaires Sociales (IGAS) saida diabetes drug which caused up to 2,000deaths should have been banned ten yearsearlier. The drug, benfluorex, but morecommonly known as Mediator, shouldhave been banned as early as 1999, when itbegan to emerge that it could cause heartdisease, the report said. Several otherEuropean countries and the US thenwithdrew it. Mediator remained on sale inFrance for another ten years. The FrenchHealth Products Safety Agency has esti-mated that between 500 and 2,000 peoplein France died because of its side effects.The drug was developed to treat diabeticsbut millions of people took it simply tolose weight.
The IGAS said it was incomprehensiblethat the authorities had failed to act sooner.Speaking to The Lancet, Irène Frachon, achest physician at CHU de Brest, said thatshe was surprised by the report’s findings“because it showed the scandal was worsethan I had expected”, adding that “perhapsI am naive, but I thought at first that therehad just been a mistake. I hadn’t realisedthat there were so many alarm bells andwarnings during all those years.”
Mr Bertrand said it was now his duty torebuild the regulatory system to protectthe public, saying that France needed tomove to a more transparent system wheredrug safety approval deliberations wererecorded, debates published and publichearings held when needed. On Europe 1radio on 16 January he also said that he andall French health ministers since 1976,when benfluorex first hit the market,should speak at the parliamentary hearingson the issue that are now getting underway.
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He also stated that the regulatory agencyshould have sufficient state funds so as notto have to rely on the industry it is sup-posed to oversee and that all medicalexperts would be obliged as a matter ofcourse to declare any links to drug firms.In June, the IGAS will present the gov-ernment with a second report proposingways to reform the pharmocovigilancesystem and the French Health ProductsSafety Agency (AFSSAPS).
The Lancet article on the report is available at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960334-6/fulltext
The IGAS report in French can be downloaded at http://www.igas.gouv.fr/spip.php?article162
Spain: report on implantation cards andsecurityThe Spanish Data Protection Authority(SDPA) has issued a report on the level ofsecurity that the data controller or, whereappropriate, the data processor, mustprovide for a file containing copies ofdevice implantation cards completed inaccordance with Article 33 of RoyalDecree 1591/2009 of 16 October, whichregulates medical devices. This was pre-pared in response to a request filed by amanufacturer of implantable medicaldevices.
The report states that “in this case wherethe file will contain a set of data relating tothe medical act of the implant in relation toa particular person, identified by her/hisID or passport, health related data areprocessed and therefore are subject tomeasures of high-level security, in accor-dance with Article 81.3 of the SpanishRegulations implementing Law 15/1999.”
According to Royal Decree 1591/2009, theimplantation card is completed in trip-licate: a copy is stored with the patient'smedical notes, another is provided to thepatient and the third is sent to the supplier(manufacturer or distributor of theproduct), which, where appropriate, sendsa copy to the relevant national registry ofimplants.
The following implants being distributedin Spain are required to be accompanied byan implantation card: cardiac implants andvascular implants of the central circulatorysystem; central nervous system implants;spinal implants; hip implants; kneeimplants; breast implants; and lensintraocular implants. The implantationcards, which must be completed by the
health centre immediately after the deviceimplantation has been undertaken mustcontain the following information: nameand model of the product; batch code orserial number; name and address of themanufacturer; name of the health centrethat carried out the implantation and thedate; and patient identification (identitycard or passport number).
More information is available (in Spanish)at: http://www.agpd.es/portalwebAGPD/index-ides-idphp.php
Sweden: new legislation on the collection and storage of human biological materialA new Biobanks Act regarding the col-lection and storage of tissue samples andother human biological material has beenproposed in Sweden. It aims to clarify therequirements for the release of tissuesamples from biobanks. The previous Actof 2003 was viewed as overly complicatedand unclear, thus a report was produced tofind an appropriate balance between theimportance of making tissue samplesavailable for care, treatment and researchon the one hand, and ensuring the privacyand right to self-determination of thedonor on the other.
The scope will be extended as the currentAct applies to tissue samples from themedical care system only, whilst the pro-posed new Act also covers samples fromother activities such as from within thepharmaceuticals industry. Also, under thecurrent Act, it is always necessary to obtainthe consent of the donor to collect andstore tissue samples. Under the proposednew Act, it will be possible to collect andstore tissue samples for certain limited pur-poses, provided the donor does not objectto this. The donor must, however, beinformed. In other cases, express consentis required.
Regulations on traceability are proposed inthe new Act; tissue samples from themedical care system would have to be reg-istered in the Swedish Biobank Registryand other samples must be registered at thebiobank itself. It is proposed that pro-cessing of personal data by biobanks shallbe subject to regulation, which is not thecase in the current Act. Such regulatoryprovisions would clarify where responsi-bility for personal data lies, the purposesfor which personal data may be processedand what personal data may be processed.
In order for the proposed legislation to beimplemented, the abovementioned report
will be reviewed and subjected to commentby various government authorities andcompanies affected. Next, the Ministry ofSocial Affairs will draw up a finalised billthat will be referred to the Council on Leg-islation before it is finally submitted forapproval to the Swedish Parliament. If allgoes to plan, the new Act will likely enterinto force on 1 January 2012.
The report is available (in Swedish) and asummary (in English) at:http://www.regeringen.se
Germany: uniform standards for a European-wide harmonised risk assessment The Federal Institute for Risk Assessment(BfR) has published a guidance documentfor health assessments in the field of con-sumer protection. This GuidanceDocument shall serve as a basis for theassessment of possible health risks offoods, chemicals, and consumer productsand will pave the way for a harmonisationof risk assessment.
BfR is a scientific institution responsiblefor preparing expert reports and opinionson food and feed safety, as well as on thesafety of substances and products. Itcomes under the portfolio of the FederalMinistry of Food, Agriculture and Con-sumer Protection (BMELV). The mainareas of BfR’s work encompass the healthassessment of biological and material-chemical safety of food, health assessmentof the safety of substances (chemicals, pes-ticides and biocides) and selected products(consumer products, cosmetics, tobaccoproducts, textiles and food packaging).Additionally, BfR assesses risks of geneti-cally modified organisms in food, feed,plants and animals and is responsible forrisk communication.
The Guidance Document implementsinternational principles of risk assessment.Specifications for the scientific content andthe appropriate structuring of healthassessments as they result from science andlegislation as well as practical experienceare compiled. The Guidance explains thefundamentals of BfR health assessments;particularises the content and structure ofBfR Opinions; explains typical risk termi-nology; and lists important documents forthe risk assessment.
The Guidance Document is available at:http://www.bfr.bund.de/cm/364/guidance_document_for_health_assessments.pdf
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New report: How health systems makeavailable information on serviceproviders: experience in seven countriesThis new report produced by RANDEurope and the London School of Hygiene and Tropical reviews informa-tion systems that report on the quality orperformance of providers of health carein seven countries (Denmark, England,Germany, Italy, the Netherlands, Swedenand the United States). This is to help inform the use and further developmentof quality information systems in theEnglish NHS. The review highlights thatas the policy context for quality reportingin countries varies, so also does the nature and scope of quality informationsystems within and between countries.
The report is available athttp://www.rand.org/content/dam/rand/pubs/technical_reports/2011/RAND_TR887.pdf
Scotland: Free prescriptions for all fromApril 2011On 2 March, the Scottish Parliament'sHealth Committee passed legislation thatwill result in prescriptions for all patientsin Scotland being free from 1 April. Prescription charges have been fallingsteadily since 2007. In 2007 a single itemprescription cost £6.85, this was reducedto £5.00 in 2008–09, £4.00 in 2009–10 and£3.00 in 2010–11.
eHealth moves ahead in EuropeA report produced for the EuropeanCommission by a consortium led by theGerman consultancy Empirica, reportson eHealth strategies and implementationin thirty countries.
The report notes that EU countries aremaking substantial progress towardsmodern eHealth infrastructures and implementation. Virtually all have already started with, or will undertake,the implementation of national systemsto make basic patient data available to allhealth-care professionals whenever andwherever needed.
While electronic health record (EHR)systems are a consistent element in almost all strategies and roadmaps, theyare not well and/or consistently defined,often referring only to a patient summaryor similar basic electronic patient record.Clinicians enthusiasm for comprehensive
EHR relates to perceived benefits in theirimmediate surroundings (their day-to-day work processes) rather than to a geographically widespread sharing of detailed patient data.
The report can be accessed athttp://www.ehealth-strategies.eu/report/eHStrategies_Final_Report.pdf
Nuffield Trust report on US experience ofGP commissioningSubstantial investment in leadership,management and informational technol-ogy, combined with a focus on helpinggeneral practitioners (GP), work in newways and collaborate more closely withtheir specialist colleagues is vital if theEnglish Government’s plan to hand control of NHS budgets over to groupsof GPs is to succeed.
This is the verdict of a new NuffieldTrust report, GP commissioning: insightsfrom medical groups in the United States,by Ruth Thorlby, Rebecca Rosen and Judith Smith. It examines the Americanexperience of handing the equivalent ofcommissioning budgets to doctors overthe past twenty years. The researchersvisited a number of medical groups ledby doctors in California and argue thatthe experiences of these organisations reveal important lessons for the NHS inEngland as the Government prepares totransfer control of £80 billion of theNHS budget to GP consortia.
The report is available athttp://www.nuffieldtrust.org.uk/publications/detail.aspx?id=145&PRid=756
Workplace violence and harassment onthe increase in EuropeViolence, bullying and harassment are becoming increasingly common featuresof European workplaces, according to anew report by the European Agency forSafety and Health at Work (EU-OSHA).Yet the response from organisations andnational governments is widely felt to beinadequate. Third-party violence and ha-rassment affect from 5% to 20% of Eu-ropean workers, depending on the coun-try, sector, and methodology employed.
The report Workplace Violence and Harassment: a European Picture includesinternational statistics collected by theEuropean Risk Observatory, part of
EU-OSHA. Its recent pan-Europeanworkplace survey of enterprises on newand emerging risks (ESENER) alsoshows that 40% of European managersare concerned by workplace violence andharassment, but only around 25% haveimplemented procedures to deal with it –in many EU countries not more than10%. The problem is even more acute inhealth and social work and in educationwith more than 50% of managers identi-fying it as a health and safety problem.
The full report is available athttp://osha.europa.eu/en/publications/reports/violence-harassment-TERO09010ENC/view
Launch of consultation on health securityin the EUOn 3 March, the European Commissionlaunched a consultation to gather viewson possible actions that can protect EUcitizens more effectively against seriouscross-border health threats.
Current EU legislation does not covercross-border health threats other than in-fectious diseases. The aim of this initiativeis to consider the possibility and need toensure that all types of public healththreats are addressed in a similar way toinfectious diseases. The overarchingquestion is: How can the response to infectious diseases and other seriouscross-border health threats, such aschemical, biological, radiological, nuclearand environmental events, be strength-ened at EU level?
The consultation includes questions onpreparedness planning, risk assessment,management of health threats and onhow to better communicate with citizensand professional groups.
The consultation paper and online questionnaire can be viewed at:http://ec.europa.eu/health/preparedness_response/consultations/preparedness_cons_02_en.htm. Comments should besubmitted by 29 April 2011.
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