Eurohealth, Vol.15, No.2, 2009 - World Health Organization · Our regular European snapshots...

EurohealthVolume 15 Number 2, 2009RESEARCH • DEBATE • POLICY • NEWS

Health information technology in the United State • Belarus: primary care developmentsPoland: hospital reform • Italy’s new fiscal federalism • Saudi Arabia: allocating funds to pharmaceuticals

Advancing palliative care in the EU

Increasing the use of health impact assessments

The growth of voluntary health insurance in Denmark

Parallel trade and affordable access tomedicines in the EU

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Parallel trade and affordable accessto medicines

In 2007 parallel trade of pharmaceuticals in the EU totalled €4.8bn, accounting for more than 10% of allspending on pharmaceuticals in the Netherlands, the UK,Sweden, Denmark, and Germany. Dermot Glynn writinghere in Eurohealth reports on work to examine the systemic effects of parallel trade. He finds that adverseeffects on safety through inaccurate packaging, counter-feit products and product recalls may have a cost of €0.5billion per annum; prohibiting both repackaging and re-labelling he suggests would greatly reduce the harm topatients and substantially improve access to safe and affordable medicines. In contrast, while differences inprices may lead to delays in access in some countries,Glynn concludes that any move to introduce a single EUprice for any drug would mean that it might become unaffordable in some of the poorer Member States thataccount for over 100 million of the EU’s 480 million citizens.

Elsewhere in this issue, while Health in All Policies hasbeen a mantra of policy statements now for some time,Rebecca Salay and Paul Lincoln contend that while theEuropean Commission has a rigorous system of integrated impact assessment, in practice public healthimplications are not fully considered outside of thehealth sector. They call for health impact assessments tobe made a mandatory core activity of the Commission –otherwise they suggest public health will continue to be a hit and miss, marginal consideration.

Meantime, Jose M Martin-Moreno and colleagues drawour attention to their report for the European Parliamenton the state of palliative care in Europe, setting out different options for policy change. They note that greatdifferences in approach and access to palliative care services remain across the EU, but as yet the topic hasnot commanded great visibility at an EU level. Thismight, in part, be about overcoming some of the taboosassociated with this sensitive subject. Clearly much moreneeds to be done to raise awareness, disseminate knowledge, and fight for lasting improvements in thisfield.

Our regular European snapshots feature includes articleson Poland, Belarus and Italy, while Karsten Vrangbæklooks at the growth in voluntary health insurance inDenmark. We also seek to learn from experience elsewhere, here looking at funding for pharmaceuticals in Saudi Arabia and the use of information technology inthe United States.

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Contents EurohealthVolume 15 Number 2

Ali S Al Akeel is Consultant Pharmacologist, TMPUniversity, Japan.

Khaled A Al Hussein is Consultant Paediatricianand Associate Professor, University of Oklahoma,USA.

Jim Attridge is Research Fellow in the Health Management Group, The Business School, Imperial College, London, UK.

Carlos Centeno is based at the University ofNavarra Clinic, Pamplona, Spain.

David Clark is Director of the International Observatory on End of Life Care, Lancaster University, UK.

Natasha Desai is Research Assistant, LSE Health,London School of Economics and Political Science,UK.

George France is based at the Institute for theStudy of Regionalism, Federalism and Self-govern-ment, Consiglio Nazionale delle Ricerche, Rome.

Marin-Gemmill-Toyama is Research Officer, LSEHealth, London School of Economics and PoliticalScience, UK.

Dermot Glynn is Chairman of Europe Economics,London, UK.

Lydia Gorgojo is Research Associate, the MedicalSchool and University Clinical Hospital, Universityof Valencia, Spain.

Meggan Harris is Research Assistant, the MedicalSchool and University Clinical Hospital, Universityof Valencia, Spain.

Adam Kozierkiewicz is an independent consultant.

Brendan Krause is Fulbright Scholar, LSE Health,London School of Economics and Political Science,UK.

Paul Lincoln is Chief Executive, National Heart Forum, London, UK.

Jose M Martin-Moreno is Professor of PublicHealth, the Medical School and University ClinicalHospital, University of Valencia, Spain.

Erica Richardson is Research Fellow, LondonSchool of Hygiene and Tropical Medicine, UK.

Charles Normand is Edward Kennedy Professor ofHealth Policy & Management, Trinity College,Dublin, Ireland.

Valentin Rusovich is National Professional OfficerCommunicable Diseases (Tuberculosis), WHOCountry Office, Belarus.

Rebecca Salay is Policy Researcher, NationalHeart Forum, London, UK.

Karsten Vrangbæk is Associate Professor, Department of Political Science, University ofCopenhagen, Denmark.

Health Policy Developments1 The effects of parallel trade on affordable access to medicines

Dermot Glynn

5 Going private? The growth of voluntary health insurance in DenmarkKarsten Vrangbæk

9 Improving efficiency of allocating public funds to pharmaceuticals: A pilot study in the Kingdom of Saudi ArabiaKhaled A Al Hussein, Ali S Al Akeel and Jim Attridge

Snapshots15 Belarus: developments in primary care

Valentin Rusovich and Erica Richardson

17 Poland: will legal restructuring affect the (real) economy of hospitals?Adam Kozierkiewicz

18 Italy’s new fiscal federalismGeorge France

Public Health Perspectives20 Increasing the use of health impact assessments: is the environment

a model?Rebecca Salay and Paul Lincoln

Palliative Care23 Transforming research into action: a European Parliament report

on palliative careJose M Martin-Moreno, Meggan Harris, Lydia Gorgojo, DavidClark, Charles Normand and Carlos Centeno

Perspectives from the US26 Health information technology in the United States:

can planning lead to reality? Natasha Desai, Brendan Krause and Marin Gemmill-Toyama

Evidence-informed Decision Making 29 “Mythbuster” In health care, more is always better

31 “Bandolier” Assessing relative efficacy of antidepressants

Monitor34 Publications

35 Web Watch

36 News from around Europe

Eurohealth Vol 15 No 21

HEALTH POLICY DEVELOPMENTS

This paper is based on research commis-sioned by the EC to help assess the impactof policy options1,2 to ensure safe medi-cines through parallel trade; and reduce therisks of counterfeit medicines in the EU. Tothe best of our knowledge this was the firstsuch work to have been commissionedfrom the perspective of patients rather thanmanufacturers or traders. The manufac-turers’ trade association, the EuropeanFederation of Pharmaceutical Industriesand Association (EFPIA) had assembled adossier of complaints which the Commis-sion took seriously.

Market size and natureParallel trade in 2007 was about €4.8bn, asignificant increase on the previous year,and accounted for more than 10% ofspending on pharmaceuticals in theNetherlands, the UK, Sweden, Denmark,and Germany. According to industry esti-mates about 140–150 million packages arehandled by parallel traders each year, mostof which are either repackaged or re-la-belled by the parallel trader or his agent.

The proportion of spending on particulardrugs represented by parallel imports isoften very much higher than 10%, and mayexceed 50%, since parallel traders generally

concentrate on the most importantpatented medicines. The products mostsubject to parallel trade include Lipitor andCozaar (cardio), Zyprexa, Risperdal, andEffexor (central nervous system), Casodex,Zoladex, and Arimidex (oncology), Nex-ium (gastro-metabolism), as well as Plavix(reduction of atherothrombotic events) andSeretide and Symbicort (asthma). These areimportant medicines for serious conditionsand long term prospects for the volumes ofparallel trade depend on the extent of priceconvergence in the Internal Market and onthe outcome of some current court cases.Currency fluctuations in the current eco-nomic crisis are also affecting the directionof trade.

The legal and policy framework Member States have primary responsibilityfor health care, while Article 95 of the ECTreaty is the basis for EU legislation re-garding the establishment and functioningof the Internal Market. The EC Treaty re-quires that the objective of removing un-justified constraints on the free movementof goods (Article 28) should be set aside

where necessary to protect patient safetyand health (Article 30) or intellectual prop-erty. Articles 81 (preventing agreementsthat restrict competition and trade) and 82(preventing the abuse of dominant posi-tion) are also not intended to prevent ac-tions beneficial to consumers. Thus it maybe argued that the Treaty makes free move-ment of goods subordinate to the objectiveof achieving a high level of patient safetyand access to medicines.

The pharmaceuticals directive and the di-rective frameworks for good manufactur-ing principles and good distribution prin-ciples include only limited detailspecifically relevant to parallel trade. Theapplication of the primary legislation toparallel trade has therefore been mainlythrough decisions by the European Courtof Justice (ECJ), decisions which have beenmade on cases relating to intellectual prop-erty and market access rather than the direct interests of patients.* This meansthat the ECJ has not so far been presentedwith detailed evidence about the systemic effects of parallel trade.**

The effects of parallel trade onaffordable access to medicines

Dermot Glynn

Summary: A stylised demand curve for patented medicines in the EU wasconstructed and the price and availability of medicines were predicted bycomparing the situation in which prices converge with differentiated prices.Parallel trade causes prices of patented medicines to converge. A single EU pricewould reduce both the numbers of patients with affordable access to patentedmedicines and profits by about 25% compared to optimally differentiated prices.The best option from the point of view of health care policy would be to prohibitthe repackaging of medicines and require traceability throughout the supply chain.

Keywords: Parallel trade, affordable access to medicines, internal market, repackaging

Dermot Glynn is Chairman of EuropeEconomics, London, United Kingdom. Email: [email protected]

* However, in a decision of 2006 (T-168/01) the Court of First Instance considered whethera pharmaceutical manufacturer may rely on Article 81 (3) to justify a dual pricing system.

** Analysis of systemic effects would explore the likely economic and social effects of theparallel trade system as a whole, in addition to the effects of specific transactions (so, forexample, a systemic analysis would consider the probability that widespread repackagingand re-labelling would lead to a percentage of error, whilst analysis of specific cases wouldfocus on the feasibility of repackaging and re-labelling taking place without adverse result).


Findings

Repackaging and re-labelling

A significant proportion of the 140–150million packs of medicine handled by par-allel traders each year include out of datepackage leaflets. No official estimates areavailable, because no regulatory authoritymakes systematic checks, but surveys bymanufacturers have found that up to 60%include a mistake of some sort. Some ofthese mistakes concern intellectual prop-erty issues rather than mistakes directlylinked to patient safety, but taking a con-servative view some 20% of parallel tradedpacks include out of date or otherwise inaccurate information.

Not all package leaflets are read by pa-tients, and not all the inaccuracies wouldmatter to the patients who do read them.Studies have been made of the numbersreading packs, and on the basis of these itis reasonable to assume that about half ofthe inaccurate leaflets are read. The averageharm experienced by patients receiving inaccurate information was taken to be halfa quality adjusted life year with some additional economic costs.

Apart from the question of package leaflets,repackaging and re-labelling mean thatconfusion may be caused by alternatepackaging or names for what should be thesame medicine; patients may not take med-ication as intended; and compliance withprescription regimes may be reduced.

Product recalls

There are a significant number of productrecalls (400 in 2006) so that reliability of thesystems involved is a significant patient in-terest.* Parallel traders sometimes use aseparate batch number in addition to themanufacturer’s number. The increasednumber of transactions involved in paralleltrade and the parallel traders’ wish for con-fidentiality about the supply chain meanthat product recalls initiated for any reasonare likely to be less effective.

Risk of counterfeits

The UK Medicines and Healthcare prod-ucts Regulatory Agency (MHRA) believesthat before 2007 fewer than 10,000 packs ofcounterfeit product reached patients, butincidents in 2007 allowed 30,000 packs toreach patients. There is a move from‘lifestyle’ product counterfeiting to inci-

dents involving life-saving products, andindications that parallel traders may havebeen targeted.

Overall effects on safety

It seems possible that inaccurate repackag-ing and the increased risks of other sorts re-duces the value of the products deliveredthrough parallel by 10% or more, equiva-lent to roughly €0.5 billion per annum.There are no benefits to patient safety tooffset against these losses.

Effects on affordable access to medicines

Continuous supply

There have been periodic shortages (‘stock-outs’) of medicines as available supply isshipped abroad from low-price countriesor interruptions to supply elsewhere meanthat the parallel traded product is not avail-able. EU legislation was introduced (2004amendment to Article 81 of Directive2001/83/EC) to require continuous sup-ply, with relevant legislation implementedin Austria, Denmark, Finland, Nether-lands, Romania, Sweden, Spain, and theUK. However there have been reports ofsupply shortages even after implementa-tion of new legislation. The most seriousshortages occurred in markets that are sig-nificant exporters or importers of paralleltraded products.

Introduction of new medicines to market

When a new medicine is approved thepatent holder receives a market authorisa-tion. This may be for individual MemberStates, or for the EU as a whole (centrallyauthorised products), but in either case reg-ulatory authorities throughout the EUmust accept the medicine.

Manufacturers naturally defer agreeingprices in lower-income Member States.This is because such prices would be belowaverage and result both in parallel exports,undermining profitability where incomesare higher, and in the low price being usedin reference price comparisons, equally tothe economic disadvantage of the patent-holder. Studies have confirmed that pa-tients in lower income Member States haveto wait for significant periods after newmedicines are marketed elsewhere beforethey are provided with access, for instancewith one study noting that “to the extentthat prices are correlated with incomes,permitting parallel trade in the EU wouldlead to reduced access to new drugs in thelow-income EU countries”.3

Price convergence and affordable access

Any form of arbitrage will lead to priceconvergence. Figure 1 illustrates how pricetrends converged between 1986 and 1999.In many markets economists would expectcompetition to cause prices to tend to converge around those offered by the mostefficient (low cost) suppliers. However, thisdoes not apply in the case of patented

Eurohealth Vol 15 No 2 2


* It was not possible to obtain representative estimates from regulators or companies of thenumber of packets that reach patients despite recalls or of the reduced effectiveness (if any)of recalls due to manufacturers’ error, regulatory intervention or involvement of paralleltrade. This is a weakness in present arrangements to monitor the market.

60

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1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

UK

Germany

Holland

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Figure 1: Price comparisons at the pharmacy purchase level for selected EU Member States,1986–1999 (Sweden = 100)

Source: Data are taken from the AIP index from Apoteket AB, providing price comparisonsfor pharmaceuticals in Sweden and a number of European countries. Comparisons made inJanuary 1999 are based on 150 brands with the highest value sales in Sweden in the previousyear

pharmaceuticals where each supplier hasan exclusive right to supply its uniqueproduct.

Patent holders launching new productsmust try to set prices at the most profitablelevels for the market as a whole. If paralleltrade is likely, prices will be about the samein each country, whereas in the absence ofparallel trade the profit maximising pricingstrategy would normally be to charge dif-ferent prices in high and low income Mem-ber States, reflecting what the health careservices or insurers are willing to pay. Itfollows inevitably that price convergencewill add to the prices of patented medi-cines in Member States with lower in-comes, from which parallel exports are

most likely to be made. This is a point ofgreat practical significance since there aresubstantial differences in income levels between Member States.

At the time of the study the most substan-tial importers of parallel traded medicineswere Germany, the Netherlands, the UKand Sweden (combined population about170 million and average income per headabout €31,000 in 2008). Nine MemberStates had a Gross Domestic Product(GDP) per head less than half the EU aver-age: Bulgaria, Romania, Lithuania, Latvia,Poland, Slovakia, Hungary, Estonia and theCzech Republic (combined populationover 100 million and average income perhead about €8,600 in 2008). Figure 2 shows

the proportion of average income thatwould be needed in each EU Member Stateto pay for a course of treatment costing€1,000. It clearly indicates that a single EUprice would imply that medicines may notbe affordable in lower income parts of theEU.

Quantification of effects The previous section reported an estimatethat repackaging and other effects of par-allel trade represent a disbenefit to patientsthat is equivalent to about 10% of the valueof parallel trade, i.e. about €5 billion in2007. However, the central issue for EUhealth care policy is in denying affordableaccess to patented medicines. If paralleltrade were constrained, for example, byprohibiting repackaging and by requiringtamper-proof sealing of packs, then patentholders would be expected to charge dif-ferent prices according to what each part ofthe market would bear.

Making use of 2008 population and incomelevel data for each Member State, if theGDP per capita of a country is roughlyproportional to the price that country’shealth service would wish to pay, and thatthe population of a country indicates thenumber of potential patients, then it is pos-sible construct a stylised demand curve forpatented medicines (Figure 3).

The solid line shows the demand curve for patented medicines and the dashed greyline represents a roughly constant cost ofmanufacturing and distribution assumedto be 5% of the EU average price. The area



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Figure 2: Percentage of average income needed to pay for a treatment costing €1,000,2008

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Cumulative population (millions)

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Figure 3: Demand curve for patented medicines in the EU, 2008



between the two lines therefore representsthe return of investment in research and de-velopment (gross profit) that would resultfrom differentiated prices. An index repre-senting gross profit can be estimated bymultiplying the price of medicines by thepopulation for each country, totalling for

all twenty-seven Member States, and sub-tracting the cost of manufacturing and dis-tribution.

If a uniform price across the EuropeanUnion were to be adopted, its most prof-itable level is the point at which gross rev-

enues (sales x price) are maximised (seeTable 1). Using these figures, sales revenuesand gross profits would be maximised at aprice of €97 with sales of €355,048,324.On these assumptions of an overall EUpopulation of 482 million, over 100 millionwould not be supplied if a single EU price

Table 1: Comparison of the effect of differentiated and single prices on potential sales and profits

Member State ranked by GDPper capita as % of EU average

(A)

Population (2008)

(B)

Potential sales per country (C = A x B)

Cumulative population(2008)

(D)

Cumulative potential sales

Differentiated prices Single prices

Luxembourg 273 429,200 1,171,716 429,200 1,171,716 1,171,716

Ireland 140 3,700,000 5,180,000 4,129,200 6,351,716 5,780,880

Netherlands 131 15,800,000 20,698,000 19,929,200 27,049,716 26,107,252

Austria 125 8,100,000 10,125,000 28,029,200 37,174,716 35,036,500

Denmark 123 5,300,000 6,519,000 33,329,200 43,693,716 40,994,916

Sweden 119 8,900,000 10,591,000 42,229,200 54,284,716 50,252,748

Belgium 118 10,200,000 12,036,000 52,429,200 66,320,716 61,866,456

Finland 115 5,100,000 5,865,000 57,529,200 72,185,716 66,158,580

United Kingdom 114 58,600,000 66,804,000 116,129,200 138,989,716 132,387,288

Germany 111 82,000,000 91,020,000 198,129,200 230,009,716 219,923,412

France 108 60,400,000 65,232,000 258,529,200 295,241,716 279,211,536

Spain 103 39,400,000 40,582,000 297,929,200 335,823,716 306,867,076

Italy 98 57,600,000 56,448,000 355,529,200 392,271,716 348,418,616

Greece 97 10,500,000 10,185,000 366,029,200 402,456,716 355,048,324

Cyprus 92 865,000 795,800 366,894,200 403,252,516 337,542,664

Slovenia 91 1,985,000 1,806,350 368,879,200 405,058,866 335,680,072

Czech Republic 82 10,285,000 8,433,700 379,164,200 413,492,566 310,914,644

Malta 77 390,000 300,300 379,554,200 413,792,866 292,256,734

Poland 73 38,655,000 28,218,150 418,209,200 442,011,016 305,292,716

Portugal 71 10,800,000 7,668,000 429,009,200 449,679,016 304,596,532

Slovakia 68 5,395,000 3,668,600 434,404,200 453,347,616 295,394,856

Estonia 63 1,440,000 907,200 435,844,200 454,254,816 274,581,846

Hungary 62 10,070,000 6,243,400 445,914,200 460,498,216 276,466,804

Lithuania 55 3,700,000 2,035,000 449,614,200 462,533,216 247,287,810

Latvia 52 2,400,000 1,248,000 452,014,200 463,781,216 235,047,384

Romania 45 21,700,000 9,765,000 473,714,200 473,546,216 213,171,390

Bulgaria 39 7,970,000 3,108,300 481,684,200 476,654,516 187,856,838

Gross profits (maximum total sales -5% of cost at average EU price) 452,821,790 336,746,864

Cumulative sales potential calculations: Differentiated prices = cumulative sum of C; Single prices = A x D

Over the past decade there has been sig-nificant growth in the market for supple-mentary health insurance in Denmark. Twotypes of voluntary health insurance (VHI)

are sold. The first provides access to privateproviders and is now held by around onemillion Danes (18% of the population).The second provides a lump sum in theevent of critical illness and covers almost2.2 million Danes.1 This rapid increase inVHI comes in addition to complementaryhealth insurance, which is held by aroundtwo million Danes. The growth in VHI

raises important questions on the drivingforces and potential consequences for thepublic health system. These questions willbe addressed following a brief presenta-tion of some facts on this phenomenon.

The development of the Danish VHImarketComplementary health insurance has been

were to be adopted. Gross profits wouldalso be substantially lower (see Table 2).

There is a wealthy minority in the low – in-come Member States who would obtainsupplies at the higher price and, for a vari-ety of practical reasons even with the in-fluence of parallel trade, prices would notbe identical throughout the EU. Thiswould not, however, change the overallconclusions as presented here. Prohibitingboth repackaging and re-labelling would

greatly reduce the harm to patients result-ing from present EU policy and substan-tially improve patients’ access to safe andaffordable medicines.

REFERENCES

1. Europe Economics. Safe MedicinesThrough Parallel Trade: Contribution to an Impact Assessment. London, EuropeEconomics, 2008. Available at

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_10/report13may_corr.pdf

2. Europe Economics. Policies to CombatCounterfeit Medicines: Contribution toImpact Assessment. London, Europe Economics, 2008. Available at http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/conterfeit_doc/11-11-2008/counterfeit-study-main-report.pdf

3. Danzon PM, Wang YR, Wang L. Theimpact of price regulation on the launchdelay of new drugs – evidence fromtwenty-five major markets in the 1990s.Health Economics 2004; 14(3):269–92.

This paper is based on recent work carriedout by Europe Economics on behalf of theEuropean Commission (DG Enterprise).We are required to mention the amountpaid by the Community (€187,500) andto state that the opinions expressed arethose of the Contractor only and do notrepresent the Commission’s official position.



Table 2: Comparison of single price with differentiated prices

Single EU price Differentiated prices

Patients supplied 366,029,200 100 481,684,200 132

Gross Profits €336,746,864 100 €452,821,790 134

The most recent series providing the data from which Figures 2 and 3 and Tables 1 and 2below are derived are in Eurostat annual national accounts-auxiliary indicatorsnama_aux_gph select NGDPH 2008 and demography – national data-populationdemo_pjan select 2008. The data have been revised very slightly from those from which theFigures and Tables were drawn.

Going private? The growth of voluntaryhealth insurance in Denmark

Karsten Vrangbæk

Summary: Over the past decade there has been significant growth in the market for supplementaryhealth insurance in Denmark. Two types of voluntary health insurance (VHI) are sold. The firsttype provides access to private providers. This type of insurance is now held by around one millionDanes (18% of the population). The second type provides a lump sum in the event of critical illnessfor almost 2.2 million Danes. This rapid increase in VHI comes in addition to complementaryhealth insurance, which is held by around two million Danes. The growth in VHI raises importantquestions on the driving forces and potential consequences for the public health system.

Keywords: voluntary health insurance, Denmark, health reform

Karsten Vrangbæk is Associate Professor,Department of Political Science,University of Copenhagen, Denmark.Email: [email protected]

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_10/report13may_corr.pdf

http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/conterfeit_doc/11-11-2008/counterfeit-study-main-report.pdf


a widespread practice in the Danish healthsystem since the 1970s. It has traditionallybeen used to cover co-payments in thestatutory system (mostly for pharmaceuti-cals and dental care), and for services notfully covered by the state (for example,physiotherapy). The not-for-profit organ-isation ‘Danmark’ used to be the soleprovider of such complementary insurance.It covered around two million Danes in2007 (36% of the population).

The widespread use of supplementary VHIis a relatively recent phenomenon. In 2002,there were around 130,000 people with thisinsurance, a figure that had grown to al-most one million by 2008. These insuranceplans provide access to private treatmentfacilities. In addition, there are now 2.2million Danes with insurance that providesa cash lump sum in the event of critical ill-ness. This type of insurance is typicallylinked to pension plans and is not the mainfocus of this article.

The actual utilisation of the VHI insurancepolicies remains limited so far. This is dueto the fact that the uptake of VHI has beenmostly by younger, healthier people. In-surance holders are mostly private em-ployees aged between 25 and 60. Peoplewith longer educations and higher incomeare relatively more likely to have insurancethan less educated people.1,2 Supplemen-tary insurance paid out around DKK 220million in 2002 rising to DKK 754 million(€101 million) by 2007 and an estimatedDKK 1 billion in 2008 (€134 million). Thisfigure can be compared with a total publichealth expenditure for hospitals of DKK57.7 billion (€7.7 billion) in 2006.

Thus, the general trend is a gradual increasein utilisation as more people become en-rolled, the age of insurees increases andprivate supply expands. Significant events,such as the nursing strike in the public sec-tor in 2008, have accelerated this utilisationtrend due to adverse effects on public serv-ices. From an industry perspective, VHIhas been a rather profitable business in itsearly years. The ratio of pay out/premiumincome has however increased from 58%in 2004 to 90% by 2007.2 This recent in-crease in pay out has led insurance compa-nies to raise their premium levels for 2009.

The exact composition of these expendi-tures is unknown, but information fromone of the larger insurance companies(Danica Pension) indicate that around 55%goes to surgical procedures, 21% to variousmedical consultations, 14% to physiother-apy and 6% to psychology visits. The re-

maining 5% goes to unspecified servicese.g. chiropractice. Surgical and medicaltreatments mostly concern more easilytreatable conditions and are dominated byorthopaedic surgery, sports medicine, treat-ments for slipped discs and interventions todeal with obesity. Private treatments typi-cally do not deal with acute conditions,cancer treatment, complex diseases andlong term conditions.

Explaining the growth in VHIWhy are so many VHI policies sold in asystem with universal coverage, compre-hensive services that are largely free at thepoint of use and where most users of thesystem indicate high satisfaction levels?

A change in tax rules providing tax deduc-tions for employers and tax exemptionsfor employees appears to be part of the ex-planation. This policy was introduced in2002 by the newly elected liberal-conserv-ative government with the stated intentionof encouraging employers to take a moreactive interest in the health of their em-ployees. A supplementary motive for theliberal/conservative government was tostrengthen private health supply and thusenable a more market based developmentof the health system in the future.

The change in tax rules came in a period ofhistorically high activity levels in the econ-omy with close to full employment. Com-petition for employees and the relativelyhigh marginal tax rates on regular incomecreated an environment where non taxableVHI became part of many private em-ployment benefit packages. The fact thatthe rules required companies to offer in-surance to all employees, not just the topechelons, further fuelled the growth. Thisalso meant that VHI changed status frommostly being for a small number of highstatus employees to cover all levels withinthe major private sector firms. Tightness inthe labour market has also given firms astronger interest in getting their injured orsick employees back to work as quickly aspossible. VHI has been sold as a way toachieve this.

The liberal/conservative political agendaprobably also reflects a more general shiftin the voting population towards demandsfor greater flexibility and individuality inpublic service delivery. There also appearsto be a greater acceptance of inequality aslong as basic coverage is in place. Suchtrends can be seen in other parts of theDanish welfare state. Examples include thedevelopment of a pension system, whichcombines public and supplementary pri-

vate coverage, and the long standing tradi-tion for private primary schools as a sup-plement to public schools. Yet importantly,there does not seem to have been a univer-sal loss of support for the welfare stateidea, although many small steps are gradu-ally changing the composition and func-tionality in different sectors.

The expansion of VHI can also be seen inlight of discussions about waiting timesand quality in the public sector. Recurringmedia attention indicates that at least someparts of the population have developed animage of relatively poor service and qualityin public hospitals. Interestingly this viewis not dominant among those individualsthat have actually used the health system.3

Different governments have attempted toaddress service and quality issues. Freechoice of public hospitals was introducedin 1993 and a general waiting time guaran-tee of two months providing ‘expandedfree choice’ among public and selected pri-vate providers in Denmark and abroad wasadded in 2002. The waiting time limit wasfurther reduced to one month in 2007, although this scheme was temporarily sus-pended until the summer of 2009.

The quality issue has been addressed by anumber of different initiatives including acomprehensive ‘Danish Programme forQuality Assessment’ combining accredi-tation and ongoing evaluations based onstandards and clinical databases, and thedevelopment of ‘cancer packages’ and pro-grammes for chronic care. A major struc-tural reform in 2007 created larger regionsand municipalities in order to reinforcetheir capacity to improve quality and effi-ciency through larger catchment areas andspecialisation.

Some of the stated results include an in-crease in activity and productivity levelsin Danish hospitals over the past decade.4,5

Waiting times have generally gone down,although not entirely to the target level ofone month for non life threatening dis-eases. Despite these positive developmentsthere have been ongoing media debatesabout service and quality. This has proba-bly been a contributing factor to the rise inVHI.

What are the potential consequences forthe public health system?As specified above, the utilisation of privateinsurance is still relatively low and focusedon particular types of services. Further-more, the private delivery capacity is stillvery limited compared to many other Eu-ropean countries. Table 1 for full time/part



time doctors and nurses in private hospitalsprovides an illustration, although it shouldbe noted that these figures are from 2006,and the increase in private employment,particularly part time, has since been sig-nificant.

In spite of its relatively low starting point,the growth in VHI may still lead to a num-ber of consequences in the coming years asthis type of insurance becomes morewidely used, and as private health care pro-vision expands to meet demand. The inter-pretation of possible consequences variessomewhat depending on the focus and po-litical position of the observer. The fol-lowing sections present a ‘positive’ and a‘sceptical’ perspective.

The positive perspectiveThe positive perspective emphasises thatVHI helps to develop a private providermarket, which increases total capacity inthe health system. This is useful in a systemwhere public supply is limited and waitinglists exist. VHI will thus allow a number ofpatients to be treated outside the publicsystem. These patients will not use publicresources, which may instead be used to reduce waiting times in the public sector.Shorter waiting times get people back towork sooner, and thus reduce public expenditure for social services and effi-ciency loss in the industry.2

A positive perspective also argues that VHIand the development of private healthproviders give Danish health professionalsmore opportunities and stronger incentivesto work extra hours (outside the publicsystem). This leads to a much needed in-crease in the total number of hours workedin the system. From a patient/citizen perspective, the strengthening of VHI provides more flexibility, and for both employers and patients, provide promise ofa more rapid return to work.

Additional arguments for VHI include thepossible learning effects between publicand private organisations. Private providersmay be more prone to experiment withservice and/or efficiency enhancing meas-ures in order to attract patients. This maylead to useful insights that may be takenback to public organisations. Another gen-eral argument relates to the potential foremployers to become more aware of healthissues and to devote resources to preventivemeasures. VHI is then seen as part of anoverall package agreement between em-ployers and employees, where employerstake an active interest in promoting goodhealth for their employees in order to reduce sick days and productivity loss.

The sceptical perspectiveThe sceptical perspective focuses on issuesof equity, efficiency and sustainability forthe public system. In considering equity, itis hard to deny that some inequity is in-troduced as VHI is mostly purchased byprivate sector employers whereas individ-uals outside the work force, or those em-ployed in the public sector, are largely ex-cluded.6 This has led some observers toargue that Denmark is developing a twotier system of people with and withoutVHI. Those with VHI have quicker accessto practicing specialists and private hospi-tals, at least for certain conditions. The ac-ceptance or otherwise of this situation is amatter of personal and idealogical attitudes.There are indications that the population ingeneral has become more willing to acceptinequities in health care, although it alsoappears that most Danes continue to sup-port a public system7 and continue to ex-pect a high standard within this system.An important question is whether this willcontinue to be the case in the future. Onecould imagine that growing familiaritywith VHI might lead to a situation whereVHI holders become less willing to pay

taxes to uphold a general system, whilealso paying extra for the right to accessprivate suppliers.

Moral hazard may lead to lowering of in-dication levels for treatment as providershave incentives to treat patients earlier andon more vague indications. There is also apotential risk of ordering more diagnostictests. It is difficult to document such developments, apart from the broad observation of a very high frequency ofback operations in the private sector, andvarious anecdotal evidence. Private insur-ance companies obviously have an interestin addressing the issue, but the question ishow well they are able to control the med-ical decisions. Also the risk of appearingtoo restrictive may not be positive for attracting new customers.

Furthermore, it can be argued that privateinsurance leads to growth in auxiliary serv-ices that are not strictly necessary from anarrow medical perspective (extra diag-nostic tests, ‘wellness’ services, etc.). Thismay be acceptable if there is a strong de-mand, but problematic from a more generalefficiency perspective.

Sceptics also point out, that the alternativecosts of tax exemptions are relatively high.It has been calculated that the state is ‘los-ing’ revenue at the level of DKK 470 mil-lion (€63 million) in 2007, increasing toDKK 684 million (€93 million) in 2008.2

The insurance industry argues that this ismore than outweighed by the savings ontreatment within the public system. This isbased on the assessment that all VHI spon-sored treatment is necessary, and wouldhave also been conducted in the public sec-tor.

The growth in VHI, along with the ‘wait-ing time guarantee’ providing publiclyfunded access to private providers if wait-ing times exceed one month, are the majorfactors for the expansion of privateproviders in Denmark. A major concernwith growing private provision is the factthat qualified personnel are drawn awayfrom the public sector (which paid for theirtraining). Some doctors and nurses workfull time in the private sector, while manymore work part time in the private sector inaddition to holding a regular job in thepublic sector (see Table 1). Working in bothsectors may increase total work output,but there are also risks of negative impacton motivation and performance in the pub-lic sector. It is likely that employees hold-ing more than one job will be less flexibleand less willing to take on extra duties in



Table 1. Number of doctors and nurses in public and private hospitals 2006

Doctors Nurses

Public hospitals

Full time

Part time

10,653

6,101

31,100

5,762

Private hospitals

Full time

Part time

35

142

284

457

Source: Forsikring and Pension 2008

the public sector. On the other hand, suchemployees might bring in valuable experi-ence from exposure to different organisa-tional forms.

More generally, there is a risk that the over-all level of research and educational activi-ties may suffer as private providers focustheir attention on production.

Cream skimming is also a potential riskfactor with the rise of private provision. Atthe systemic level, there has been a ten-dency for private providers to focus on rel-atively simple elective surgical treatments,while the public sector retains responsibil-ity for the more difficult and less profitabletasks of acute, long term and geriatric care,as well as psychiatry. At the individual patient level, there is a risk that privateproviders will attempt to select easier caseswithin a particularly category of patientswhile the public retains the more compli-cated cases. Finally the public system servesas a “back up” for complications devel-oped after treatment in private facilities.There is limited systematic information onthe importance of such issues.

ConclusionsAs the phenomenon of VHI is still evolv-ing, it is difficult to reach final conclusionson the validity of these various perspec-tives. To some extent it is possible that boththe sceptics and optimists are right and thatthe expansion of VHI has both positiveand negative consequences. Total capacityin the system may increase and the activitylevel may go up for the benefit of at leastsome patient groups. Yet, this is likely tocome at the expense of greater inequalitybetween those with private insurance andthose without, and between the VHI rele-vant conditions and the rest. Stronger com-petition for trained professionals and in-flationary pressure on wages may beanother consequence. Many of the issuescannot be resolved on purely objectivegrounds, although much more can be doneto illuminate the costs and benefits.

The future of VHIIt seems likely that VHI will continue toplay a role in the future, as there is clear de-mand, while resources will remain limitedin the public sector in the face of an ageingpopulation and the introduction of new,costly treatment options. Nonetheless, thedegree of growth in the VHI market willdepend on a number of factors.

First, the continued availability of tax deductions for those with VHI is probablyan important factor, particularly in light of

the fact that insurance prices are starting togo up as the insurers face growing expen-diture. Price increases have already been introduced for 2009, although not of amagnitude that is likely to halt demand forVHI unless tax rules are also changed. Thegovernment has so far been reluctant todiscuss such changes, but government sup-porters and voices inside the Conservativeparty have recently indicated an opennessto look into this issue as public funds arebecoming more constrained.

The second major factor influencing theVHI market will be developments in thepublic perception of quality and servicelevels in the public system. Much will depend on the success or failure of gov-ernment initiatives to both address waitingtimes and quality issues and subsequentlycommunicate the results. In this regard,the public health sector is facing a difficulttask as the media tend to focus on single is-sues and cases, rather than complex assess-ments of results.

A third factor for the continued develop-ment of the VHI market is the general eco-nomic climate. An economic decline with aless competitive labour market and com-panies under pressure to cut costs may leadto a reduction in the use of VHI as a fringebenefit, particularly if tax rules are changed.The global financial crisis in 2009 may havesuch a detrimental effect on the Danisheconomy. In any case, it appears that theDanish health system, and to some extentthe other Nordic health systems, are grad-ually adapting to a larger degree of private

financing and provision in their otherwiselargely public health systems.

REFERENCES

1. En million danskere har ret til privathos-pital [One million Danes have the right toprivate hospital care]. Ugebrevet A4No. 41, 1 December 2008.

2. Forsikring og Pension 2008. Available athttp://www.forsikringogpension.dk/

3. National Patient Satisfaction Survey2006. Copenhagen: Enheden for Brugerundersøgelser, 2007. Available athttp://tinyurl.com/kjv8ps

4. Danish Ministry for Health and Preven-tion. Det Danske sundhedsvæsen i nation-alt perspektiv. [The Danish health systemin a national perspective]. Copenhagen:Ministry for Health and Prevention, 2009.Available at http://tinyurl.com/ncmo2g

5. Danish Ministry for Health and Preven-tion. Det Danske sundhedsvæsen i interna-tionalt perspektiv. [The Danish health system in an international perspective].Copenhagen: Ministry for Health and Prevention, 2009. Available athttp://tinyurl.com/msmyl5

6. Kjellberg J, Søgaard J, Andreasen M.Privat/offentligt samspil i sundhedsvæsenet.[Public/private interaction in the healthsystem]. Copenhagen: Danish Institute forHealth Services Research, 2009. Availableat http://tinyurl.com/nmyrj7

7. Reports from ‘citizen meetings’ conducted by the Danish Regions in 2008.



Nordic Health Care Systems: Recent Reforms and Current Policy ChallengesThis book examines recent patterns of health reform inNordic health care systems, and the balance betweenstability and change in how these systems have developed.

The following themes are explored:

• Politicians, patients, and professions

• Financing, production, and distribution

• The role of the primary health sector

• The role of public health

• Internal management mechanisms

• Impact of the European Union

The book probes the impact of these topics and thencontrasts the development across all four countries. Theeditors also explore the extent to which a Nordic HealthCare Model exists, and the degree to which that model willhelp to explain the future direction of health policy-makingin these four countries. An additional chapter on recentdevelopments in Iceland completes the work.

FORTHCOMING PUBLICATION

Edited by John Magnussen,Karsten Vrangbæk andRichard B. Saltman

Open University Press

http://mcgraw-hill.co.uk/

html/0335238130.html

http://www.forsikringogpension.dk/

http://tinyurl.com/kjv8ps

http://tinyurl.com/ncmo2g

http://tinyurl.com/msmyl5

http://tinyurl.com/nmyrj7

http://mcgraw-hill.co.uk/html/0335238130.html



Management of national pharmaceuticalexpendituresThere is an extensive international litera-ture upon approaches to the effective andefficient management of health expendi-tures and more specifically effective costmanagement approaches to the pharma-ceutical sector. In developed countrieswithin the Organisation for Economic Cooperation and Development (OECD),in Europe and beyond, a wide range of de-mand and supply side forms of regulation

or interventions have been adopted.1–4

Table 1 provides a summary of regulatoryor negotiating policy instruments andmodels adopted across world markets withvarying degrees of success.

OECD and Middle Income Countries(MIC) face the same essential challenges

in allocating public health system funds tomedicines. Over many years a steadystream of new modern medicines have of-fered improved outcomes in many diseaseareas, which at times has driven up expen-diture on medicines faster than eitherhealth care expenditure generally or

Improving efficiency of allocatingpublic funds to pharmaceuticals:

A pilot study in the Kingdom of Saudi Arabia

Khaled A Al Hussein, Ali S Al Akeel and Jim Attridge

Summary: The optimal management of the allocation of limited public health fundsacross the growing diverse range of modern medicines is a challenge faced by both highand middle income countries. The context of this study is one in which reform strategiesaim to accelerate patient access to the best available medicines, within the context of awell-managed and efficient budgetary regime. Critical in this regard is a concern tobetter match the usage patterns of medicines with changing patterns of disease preva-lence in the local population. A second key aim is to manage the costs of establishedproducts more efficiently by the wider usage of less expensive generics in order to releasefunds to cover the cost of newer innovative products. In this article we report the resultsof a pilot study in the Kingdom of Saudi Arabia in which a model has been developedfor both recording and analysing past data on allocations across different classes of medi-cines and its use as a predictive tool to consider the potential consequences of choosingalternative priorities for future expenditure. We then explain how using the informationfrom it informed strategic decisions on policy reforms to achieve these objectives.

Keywords: Funding medicines, allocation model, Saudi Arabia, pilot study

Khaled A Al Hussein is Consultant Paediatrician and Associate Professor,University of Oklahoma, USA; Ali S AlAkeel is Consultant Pharmacologist, TMPUniversity, Japan and Jim Attridge isResearch Fellow in the HealthManagement Group, The Business School,Imperial College, London, UK. Correspondence to Dr Al Hussein, PO Box 59513, Riyadh 11535, KSA. Email: [email protected]

Table 1: Regulatory and negotiating policy instruments for medicines

Demand Side Supply Side

Physician budgets

Drug utilisation review

Prescription audits

Reimbursement

Co-payment:

Proportional/deductible

Flat rate

Generic substitution, prescribing and dispensing

Over-the-counter (OTC) switch

Government/industry agreements

Profit controls

Reference pricing (internal/external)

Price controls

Develop market for generic drugs

Volume controls

Parallel trade

Drug formularies

Pharmacoeconomic studies


growth in national Gross Domestic Prod-ucts (GDP). Although the most recent datasuggest this era may be coming to an end,two fundamental decision-making chal-lenges remain:5

– What proportion of total health careshould be spent on medicines in anygiven national context or timeframe?

– Within the expenditure on pharmaceu-ticals what criteria or principles shouldbe applied to decide how best to allocateit between different disease areas andclasses of medicines?

The first of these questions has been thesubject of international benchmarkingstudies which have identified two generaltrends. Firstly, as might be expected, aver-age levels of national expenditure increaseover the range US$ 50–400 per capita spendin proportion to increasing GDP per capita(at Purchasing Power Parity, PPP) over therange US$5,000– 40,000, reflecting afford-ability limits. Less obvious is a trend inwhich the proportion of total health careexpenditure attributable to medicines fallsfrom as high as 30% at the lower end of theGDP range to 10% at the upper end. Considerable variations in national pat-terns of expenditure make it less clear whythis is the case, although prima facie itwould appear to reflect not so much excessive expenditure on medicines in lessaffluent countries, but a substantial under-expenditure on other services, notably primary care and uptake of modern technologies in hospital settings.

We report here our experience of a pilotstudy in the public sector in Saudi Arabiato develop and explore the use of a rela-tively simple model into which historic an-nual volume and value data can be entered.This may be of interest to other health caresystems currently seeking to establish orupgrade their decision making processesin this area.

Health care and medicines in Saudi ArabiaThe Kingdom of Saudi Arabia is one ofthe largest countries in the Middle Eastwith a population of twenty-five million ofwhich approximately six million are for-eign nationals. It is a relatively ‘young’population with 40% under fifteen years ofage and only 3.5% over sixty-five. Healthcare is provided free for all Saudi citizensand expatriates working in the large publicsector.6–8 The Ministry of Health (MoH) isthe largest provider of services, covering62% of all in-patient care; other govern-

mental agencies and the private sector provide the remainder, at 20% and 17% respectively. The MoH is also responsiblefor administering a regional system of pre-ventative and primary care centre services;the latter acting as the ‘gate-keeper’ for access to the hospital sector. Since the 1970sa series of five year plans have greatly improved both the quality and nationalcoverage of services. Widening free accessto services to all social classes and geographical regions, whilst upgrading thetechnological basis of the medical infra-structure continue to be the core objec-tives. Currently there are ambitious plansto build up to two thousand new primarycare centres and to increase the hospitalbed stock with a network of fifty strategi-cally located five-bed hospitals to meet thedemand of a growing population.

Funding and provision of prescriptionmedicinesMedicines are funded by the MoH largelyon a ‘global budget’ basis for the hospitalsector. The balance of hospital expenditureon medicines, at 25–30% of total expendi-ture, is relatively high in the OECD/MICrange outlined above. It lies in a similarrange to the new EU member states ofEastern Europe. The cornerstone of policyis the principles outlined in the WHOGuidelines for Drug Policy. The prime criteria are to ensure:

– fair and equitable access to medicinesfor all sections of the community,

– efficient allocation of health care fundsand other resources, and

– that the pattern of expenditure on med-icines is constantly reviewed and up-dated to meet the changing patterns ofdiseases and health needs.

In a situation of growing demand for mod-ern medicines, good data and analysis toidentify potential areas for cost savings inrespect of older products, thus creating‘headroom’ for expenditure on new prod-ucts, is a key feature of the system.

An expenditure modelA model has been developed to analyse ac-tual expenditures on medicines using theinternationally accepted Anatomical Ther-apeutic Classification (ATC) system. Inthis pilot phase the model has been popu-lated with MoH statistics for the years 2004and 2005. Individual medical products areidentified by their registered trade names,pharmaceutical forms, dose levels and packsizes and data taken from the annual

national health statistics data base.9

The model covers 77 ATC classes, whichare subdivided into three sub-groups;

G1 Products for life threatening diseases,

G2 Products for essential medicines forimportant diseases,

G3 Products for less essential diseases.

The data base consists of a universe of 613products, for which the following metricshave been included:

– Pack sizes prescribed and dispensed

– Number of units purchased

– Price per unit

– The date at which the product wasfirst introduced into the market.

The use of the G1–G3 classification hasinternational precedents. For example, theFrench Haute Authorité de Santé (HAS)price and reimbursement system uses thisconceptual distinction, both in classifyingnew products according to their degree ofinnovative added value and as a basis fordetermining percentage patient co-payment levels.10 We recognise that thisway of classifying disease states and treat-ment classes involves value judgements anddifficult choices for border line cases andtherefore should be treated with some caution.

We have used the dates of product intro-duction into the market to classify prod-ucts according to ‘age’ into the followingfour categories:

Y1 Products introduced between1999–2004 (0–5 years old),

Y2 Products introduced between1993–1998 (5–10 years old),

Y3 Products introduced between1987–1992 (11–15 years),

Y4 Products introduced prior to 1987(15+ years).

This segmentation of expenditure basedupon product age groups, Y1–Y4, offers afairly crude way of distinguishing the mostrecent innovative products from those thatare long-established. In broad terms groupsY1 and Y2, products up to ten years oldwould, more or less equate to productswhich were patented, on the assumptionthat of the normal twenty year patent lifethe first ten years is consumed by the research and development (R&D) process,leaving only about ten further years forthe marketing phase. Beyond ten years in a



competitive market there will be increasinglevels of brand generic competition, whichwill both erode prices down to much lowerlevels and fragment the market for anygiven molecule, between the originatorsbrand and competing generics.

In Saudi Arabia, in line with many othermarkets, the generic industry sector is be-coming an established feature of supplyside competition, where there are a steadyflow of new product entrants, which areboth brand generics and minor productvariants, such as new formulations, dosageforms and combination products.

To summarise, this model provides a basecase analysis of expenditures which can beinterrogated using three key product char-acteristics; the ATC level 3 or 4 class towhich it belongs, the severity of the diseasefor which it is used (G1, G2, G3) and itsage (Y1, Y2, Y3, Y4) and at all levels of aggregation from individual product, toATC level 3 and 4 classes, to higher levelsof aggregation for specific disease statesand total expenditure levels.

The model has a facility to undertake simulations of the impact upon annual ex-penditure of the following alternativestrategies, using the following parameters:

– Selective reimbursement of ATC classesor product sub groups

– Variable levels of patient co-payment

– Price changes at the individual market,product class or ATC disease sectorlevel

– Unit/volume changes.

The base case analysisThe results of the base case analysis forMoH Hospital expenditure for the year2005 focus attention upon three dimen-sions:

(a) Expenditure by disease/therapeuticarea category

(b) Expenditure by therapeutic class andage of products

(c) Relative unit prices between thera-peutic classes and age categories.

Expenditure by therapeutic category

Figure 1 shows the spread of expenditureacross the three categories of disease, G1,G2, G3, used in the model. The Figureshows, as we would expect, that the majority of the expenditure (>70%) isspent on the more serious life threateningdiseases. However, it is notable that there

are substantial levels of expenditure on theless essential medicines. Also a more de-tailed analysis of this G3 category at theATC therapeutic class level shows that thetwo largest components are vitamins andcough/cold remedies. In category, G2,there are a wider range of therapeutic areasand product classes represented, of whichanti- infectives and analgesics are majorcomponents.

MoH expenditure by product age

The volume consumption as a function ofage is summarised in Figure 2, whichclearly shows that expenditure is domi-nated (70.2%) by products that have beenin the market for more than fifteen yearsand that products which entered the mar-ket in the most recent five years accountedfor only 3.6% of the total. Surprisinglythere is little evidence of incremental in-crease in the percentages on the intermedi-

ary 5–10 year and 10–15 year categories,which are also low.

Figure 3 shows the same analysis in valueterms with a total expenditure for the year2005 of $185m. On the basis that inevitablynewer products, particularly the newestmarket entrants, are likely to be substan-tially more expensive than the older categories this shows the expected, lesspronounced gradation in the increase inexpenditure as the product classes age i.e.15% for 0–5 years; 21% for 5–10 years;25% for 10–15 years; and 33% for prod-ucts 15+ years. A more detailed analysis ofthe products in the 0–5 year old categoryshowed that of the 15%, 9.4 % were orig-inator brands of innovative products and5.7 % were other brands or generics soldby local or international generic compa-nies.

This base case analysis suggests that even



$ millions

150

125

100

75

50

25

0Life-threatening

diseaseEssentialdiseases

Less essentialdiseases

136

30.618.4

Figure 1: Analysis of hospital expenditure in 2005 by severity of disease state (US$m)

$ millions

25

20

15

10

5

0

0–5 years 5–10 years 10–15 years 15+ years

1.09

3.88 3.61

21.7

Figure 2: MoH volume consumption (standard units) in 2005 by drug age

though for 2005 expenditure was well focussed upon serious life threatening dis-eases, most of the medicines being usedhad been in the market for at least ten years(84% by units; 64% by value).

We have also examined the ratio betweenexpenditure on chronic as opposed to acutedisease states and as a function of the dis-eases categories G1–G3, as shown in Figure4. Overall, as one might expect, the shareattributed to acute conditions falls from$75m (55%) for life threatening diseasesto $10.6m (35%) for essential diseases andto a negligible level for less essential dis-eases. However, the share held by chronic

conditions, at $61m (45%) of the lifethreatening diseases, appears to be high ina hospital setting and would perhaps meritfurther investigation at lower ATC classlevels

We have also analysed average unit prices,based upon the age segments, Y1–Y4. Theprices of medicines in the less than fiveyears old group, the newest products, at anaverage of US$25.7 were considerablymore expensive than those in the oldestcategory, at an average of US$3.26 (15year+). However the intermediate cate-gories 5–10 years old at US$9.99 were ac-tually lower than the 10–15 year category

at US$13.0. This result suggests that in thislatter category there are some anomaliesand a lack of competition in some classes.

Simulation AnalysesThis model has considerable potential forexamining a wide range of options to address questions as to what might be the impact of alternative new funding ap-proaches or provision policies for differentdisease states and product types. Thesecould include market price structures, selected price increases or decreases, limitson indications and patient categories andpatient co-payment schemes. In this initialphase we have focussed upon examining alternative reimbursement strategies. Wehave evaluated the possible cost saving potential of introducing some form ofgraduated patient co-payment scheme, inwhich medicines for life threatening diseases, G1, would continue to be 100%reimbursed, serious diseases, while G2would require a small co-payment and category G3 would have substantial co-payments. This analysis suggested theremight be some scope within the expendi-tures for G3 products to achieve savings ofaround 17–27% per annum.

DiscussionWe have reviewed Saudi Arabian policieson the reimbursement, purchasing and de-ployment of prescription medicines in thepublicly funded hospital sector. The aimhas been to ensure that investment in med-icines reflects changing patterns of diseaseincidence and prevalence in the relevantpopulation and to develop a strategy forimproving access to innovative medicinesat reasonable prices, whilst also making thebest use of less expensive older genericones.

Saudi Arabian policies have focused upona selected combination of these measures inthe past, most notably international pricecomparison (external reference pricingagainst a basket of thirty other countries.)and internal reference pricing on a productclass basis. In more recent times a policy ofselective price reductions has been adoptedon a class by class or individual product basis, with a particular concern for salesgrowth and budget impact criteria. An-other important principle has been to discriminate based upon pack value,whereby price reductions may be appliedto all packs which have a price above agiven fixed value. Pricing and admissionof products to reimbursement has recentlybegun to focus upon health technology as-sessments of relative added value within



$ millions

20

10

0

0–5 years 5–10 years 10–15 years 15+ years

3.88

80

70

60

50

40

3028.1

46.9

70.8

Figure 3: MoH value expenditure by drug age categories

$ millions

150

125

100

75

50

25

0

Life-threateningdisease

Essentialdiseases

Less essentialdiseases

Figure 4: Expenditure on acute and chronic therapies as a function of disease category

competitive existing products.

The following represent the main findingsfrom our analysis of Saudi Ministry ofHealth purchases for hospitals in 2005.

(1) Of the total hospital expenditure of$185m, the majority, $135m (73%), isallocated for treating serious life-threatening conditions which are nor-mally treated in a hospital setting.

(2) Of the total expenditure, $118m (64%)was spent on products that had been inthe market for more than ten years,which would be predominantly patentexpired products and brand genericcopies.

(3) Spending on the Less Essential Dis-eases category constituted only 10%of total expenditure, but notably thiscategory contained significant levelsof expenditure on products normallyassociated with the retail or ‘Over theCounter’ (OTC) sectors, such as vita-mins, topical creams and cough andcold remedies.

(4) Expenditure on chronic conditions,such as asthma, hypertension and hy-percholesterolemia, which can be pre-cursors to acute episodes that requirehospitalisation, do not appear to beconsistent with broader national epi-demiological data on the disease bur-den and treatment patterns for theseconditions.

(5) As only 9.4% of total expenditure iscurrently attributable to newer inno-vative products prima facie scope mayexist to improve outcomes through ahigher allocation of funds in this area.This is particularly critical for treatinglife threatening diseases which are stilltreated in large part with ‘older/offpatent’ drugs; the exception being forcytostatic and psychotropic products,where innovative products are morewidely used.

(6) Older off-patent drugs are priced rel-atively highly compared to recentlyintroduced versions of the same drugs,suggesting that lower purchase pricescould be achieved.

International ComparisonsIt is difficult to find comparable data toassess how the situation in Saudi Arabiacompares with other countries. In Table 2we show a limited set of comparative mar-ket shares of products up to five years old for selected European countries, whichfurther differentiates between innovative

originator products and brand generic,generic or copy products.

We recognise that national environmentsvary greatly in terms of the health carefunding and provision systems and the pri-ority given to different disease areas.1,4 Fur-thermore these countries are all undergoingdynamic change in regulation of access,prices and reimbursement and supply sidecompetitive structure. There is consider-able variation in uptake rates for innovativeproducts at one end of product life cyclesand the extent to which effective genericcompetition occurs at patent expiry at theother.

Thus, a country such as the UK has a longtradition of being slow to embrace newproducts and over recent years has devel-oped a highly competitive off patentgeneric market. Hence in Table 2 the 0–5year share of originator products is rela-tively low at 9.7%, whereas the share ofnew generic entrants over this period at9% is high compared to other countries. Incontrast, in France, Italy and Spain sharesheld by originator products in the first fiveyears are much higher, reflecting morerapid diffusion of innovative products, butunderdeveloped generic markets. This latter situation is now changing rapidly.11

Even within the newer EU middle incomestates of Central and Eastern Europe(CEE) there is considerable diversity in thesituation. Hungary having a liberally regu-lated market shows a relatively high uptakeof new products, contrasting sharply withPoland, where over this time frame therewere strong regulatory barriers to reim-bursing innovative new products and manydelays in the administrative procedures resulting in an abnormally low figure.

Similarly we need to be cautious in inter-preting the results for Saudi Arabia. Thedata cover the hospital market which is un-der the direction of the MoH, whereas theEU data cover both the retail and hospitalsectors. The analysis of expenditure onchronic versus acute therapies suggests thatmaybe in the Saudi Arabian context, hospitals play a more significant role indistributing chronic therapies on an ambu-latory basis that would normally be dis-tributed through primary care and retailpharmacies in EU countries. Despite theselimitations we would make the followingobservations on Table 2:

(i) By EU country standards the Saudi mar-ket appears to be less dynamic, in that forproducts less than five years old the shareof the market appears to be relatively low

both for innovative originator and otherbrand and generic entrant products.

(ii) The lower innovative product uptakemay be because the Saudi product sampleis skewed towards the acute hospital sectorand hence the impact of major new classesof primary care product categories, such asstatins or atypical antidepressants whichhave shown high growth during theseyears, will have been less prominent than inthe EU.

(iii) It may also be that formal price con-trols limit the incentive for new genericcompanies to enter the market and com-pete solely on the basis of price. An effectwidely observed in southern Europeanmarkets.4, 11

(iv) The low uptake of innovative newproducts, at a level very similar to that inthe UK, may reflect the same combinationof ‘therapeutic conservativism’ by clini-cians combined with budgetary con-straints.

Conclusions and further development ofthis type of model In the context of Saudi Arabia we see con-siderable potential to extend the use of thismodel by:

(i) Extending data collection in future yearsto build up a better understanding of ‘causeand effect’ relationships between policychanges and market outcomes.

(ii) Prospective studies of the likely impactof new technological advances in medi-cines, notably biologic products.

(iii) As part of the new primary care net-work development the model could aid de-cisions as to which products are suppliedvia ambulatory care services at hospitalsand which should be delivered and fundedthrough primary care services.

(iv) At a lower level of aggregation, ver-sions of the model could be developed forindividual general and specialist hospitals.Expert formulary committees could inputassessments of the clinical and cost-effec-tiveness of new products and examine thebudgetary consequences of alternativestrategies for patient access.

(v) Evaluate the benefits and costs care inselectively adopting patient co-paymentcontributions to medicines.

More generally many MICs are now up-grading their management systems forpharmaceuticals in response to the growingimportance of health care expenditure as aproportion of total public expenditure.





Historically decision-making has beendriven by medical need tempered by short-term perceptions of affordability. Fromboth of these perspectives the quality of decision-making has been severely limitedby a lack of epidemiological and cost datato understand trends in both need and costpatterns, as a basis for formulatingmedium-term strategies. In consequence,decision-making processes for medicinesoften rely heavily upon arbitrary annualbudget increases and ad hoc, short-termcost containment interventions on prices oraccess to reimbursement to deal with fre-quent over-expenditures. In order to moveforward toward systems based uponmedium-term strategic plans, rather than asuccession of short-term tactical responses,progress is needed on three fronts:

(a) A major increase in investment in epi-demiological data and cost data collection,taking advantage of modern informationtechnology and communication technolo-gies.

(b) The development of planning modelswhich can accommodate this data at vari-ous levels of aggregation.

(c) More sophisticated ‘trade-off ‘modelswhich improve the overall efficiency of al-locating limited funds.

This pilot study has achieved a substantialstep forward in Saudi Arabia in bringingtogether improved data collection systemsunder (a) in a decision-making model un-der (b). Clearly the further widespreadadoption of this model and population of itwith longer trend data sets will provide a

sound platform for initiatives under (c) in-volving appropriate forms of health tech-nology assessment (HTA).

Currently many MICs appear to be em-barking upon ambitious reforms adoptingthe more advanced concepts of HTA under(c), without paying adequate attention toputting in place the necessary systems andinfrastructures at levels (a) and (b). Wewould therefore commend the develop-ment of this type of model in Mic involvedin this transitional process, as part of theprogression to achieving a better servicefor patients by improving the balance be-tween the funds available for innovativenew products and the optimal use of thecheapest available generic versions of olderones.

Table 2: International comparison of value share (%) of total medicines market by product type and age category.

Country Share (%) of originator brands

0–5yr old

Share (%) of all other brand generics

0–5yr old

Share (%) of products

over 5 yr old

Comment

SAUDI ARABIA* 9.4 5.7 84.9

MAJOR EU**

Spain 18.5 7.5 74.0 High uptake of new products – weak generic competition

Italy 13.2 6.4 80.4 As above

France 13.5 7.8 78.7

Germany 10.6 12.6 76.8 High growth in generics

UK 9.70 9.00 81.3 Low innovation uptake -mature generics market

NORTH EU

Norway 19.1 8.4 72.5

Belgium 18.8 6.6 74.9

Denmark 18.1 10.8 71.1

Netherlands 14.5 1.5 84.0

Sweden 12.9 6.4 80.7

Finland 10.6 6.4 83.0

CENTRAL/EASTERN EUROPE

Hungary 13.1 9.0 77.9

Czech Republic 11.8 14.9 73.3

Poland 5.3 15.8 78.9 Very limited access to innovative products

Source: EU data from EFPIA

* Saudi Arabian data is the MoH (hospital sector) for 2005

** EU country data includes both hospital and primary care retail distribution data for 2003

References

1. Espin J, Rovira J. Analysis of Differencesand Commonalities in Pricing and Reimbursement Systems in Europe. Brussels: Commission of the EuropeanCommunities, 2007. Available athttp://tinyurl.com/kup6po

2. Freemantle N, Hill S (eds). EvaluatingPharmaceuticals for Health Policy and Reimbursement. Oxford: BMJ & BlackwellPublishing, 2004.

3. Walley T, Mossialos EA, Mrazek M, deJoncheere CP. Supply and regulation ofmedicines. British Medical Journal 2005;331:171–72.

4. Seeley E, Kanavos P. Generic medicinesfrom a societal perspective: savings forhealth care systems. Eurohealth 2008;14(2):18–22.

5. Docteur E. Pharmaceutical Pricing Policies in a Global Market. Paris: OECD,2008

6. World Health Organization. CountryCooperation Strategy for WHO and SaudiArabia 2006–2011. Geneva: World HealthOrganization, 2005. Available atwww.un.org.sa/newun/who/img

7. World Health Organization. Promotingrational use of medicines: core compo-nents. Geneva: World Health Organisation,Policy Perspectives on Medicines No 5,2002.

8. Walston S, Al-Harbi Y, Al-Omar B, Thechanging face of health care in Saudi Arabia, Annals of Saudi Medicine 2008;28(4): 243–50.

9. Saudi Arabian Ministry of Health.Health Statistics for 2005. Available atwww.moh.gov.sa/statistics/Stat_Bk1426

10. Meyer F. Presentation at the Essecmeeting on Decision Making in HealthCare, Paris, December 2008.

11. Wilsdon T, Attridge CJ, Chambers G.Competition in the EU Off-patent Market.Brussels: European Federation of Pharmaceutical Industries and Associations, 2008.


SNAPSHOTS

Belarus: developments inprimary care

Valentin Rusovich and Erica Richardson

In order to maintain the provision and ac-cess to health care services following inde-pendence, Belarus has pursued a policy ofincremental health care reform. Conse-quently the Belarusian health care systembears many of the same features as the So-viet Semashko system which the republicinherited in August 1991. However, theprimary care sector in Belarus is one area ofthe system which has seen more change inthe last decade. In common with healthsystems across Europe, primary care services have been expanded in response torising health care costs and the need to develop better ways of caring for peoplewith long term conditions.1 Evidence fromaround the world suggests that primarycare services are more technically efficientthan hospital in-patient services and healthsystems that have a greater primary careorientation have better aggregate healthoutcomes as well as better access and equity.2

Shifting the focus from secondary to pri-mary care involves a broad package ofmeasures, such as enhancing the prestige ofprimary health care, shifting resourcesaway from secondary to primary care andstrengthening the gatekeeper role of pri-mary health care practitioners.3 However,reforms designed to increase the primarycare orientation of established health caresystems can be very challenging to imple-ment in practice as their success is contex-tually dependent.2

Primary care reforms in BelarusPrimary care in Belarus has been in transi-tion since the late 1990s as the country has

experimented with different models of or-ganising services. The successful piloting ofper capita resource allocation in Vitebskoblast (region) led to the nationwide rollout of new financing mechanisms for primary health care from 2000 and the im-plementation of per capita financing forservices from 2004.1 Reforms in health carefinancing have aimed to improve efficiencyin the system by moving away from input-based financing mechanisms to reduce ex-cess capacity in the hospital sector therebyreleasing extra resources for primary careservices. The Concept on the Developmentof Health Care in the Republic of Belarus2003–2007 was envisaged as a documentwhich would guide the health care systemto a new model in which primary carewould become the main priority and resources would be allocated to it accord-ingly.1 The aim was to improve the techni-cal efficiency of the health system as awhole and reverse worrying demographictrends in the country related to the rapidageing of the population and the burden ofpremature mortality. As a result there hasbeen significant investment in order to im-prove both the quality and accessibility ofprimary care services in rural areas, namelya significant expansion in the number ofprimary care facilities and capital invest-ment to improve the state of repair of 113rural health care facilities.4 This capital investment has been accompanied by a significant investment in the retraining ofprimary care doctors working in rural areas as general practitioners.

Organisation of primary care servicesAs a result of these reforms, there is now adual primary health care system in Belarus:a system of general practitioners in rural areas and on the outskirts of some citiesand the maintenance of the traditional Semashko polyclinic system in urban areas.All primary care facilities are state ownedand financed and controlled by RegionalHealth Care Departments. In remote ruralareas primary care services are provided

Valentin Rusovich is National Professional Officer CommunicableDiseases (Tuberculosis), WHO CountryOffice, Belarus.

Erica Richardson is Research Officer,European Observatory on Health Systemsand Policies and Research Fellow, LondonSchool of Hygiene and Tropical Medicine.

http://tinyurl.com/kup6po

http://www.who.int/countryfocus/cooperation_strategy/ccs_sau_en.pdf

http://www.moh.gov.sa/statistics/Stat_Bk1426/index.html

through FAPs (feldsher-midwife [akusher]posts) staffed by mid-level medical profes-sionals. The FAPs are attached to the ruraloutpatient clinics located in the larger set-tlements and are staffed by primary caredoctors and a team of nurses. A proportionof the remote rural outpatient clinics havebetween ten and twenty beds that aremainly used for the care of older peopleand people with chronic illnesses. Of therural outpatient clinics, 70% are staffed bygeneral practitioners (retrained primarycare internists or paediatricians); the remainder still have separate doctors foradults and children.1 While the introduc-tion of general practice in rural areas hasbeen deemed a success, there are no plansto extend general practice into urban areas.

In the five regional cities and the capital,Minsk, primary care is provided throughtwo parallel networks of polyclinics (as inthe Semashko system): child polyclinicsand adult polyclinics with women’s consultation units. The main categories ofnarrow specialists for outpatient consulta-tions (surgeons, ear, nose and throat (ENT)specialists, ophthalmologists, neurologists,endocrinologists, cardiologists, and gynae-cologists in adult polyclinics) are availableat these polyclinics and patients can self-refer to the relevant specialist without areferral from a primary care internist orprimary care paediatrician. The urbanpolyclinics also have diagnostic facilities:laboratory, X-ray, ultrasound and endoscopy.1 There are separate parallel net-works of specialists and diagnostic facilitiesfor adults and children which leads to theduplication of diagnostic facilities at hospitals which also have both adult andpaediatric specialists.

Future reform challengesMany of the challenges faced in Belarusreflect similar difficulties faced in othercountries in trying to reorientate their sys-tems in favour of primary care. However,reformers are potentially in a muchstronger position to effect change in Belarus relative to other countries of theformer Soviet Union because populationhealth is a genuine political concern and thehealth care system receives significant pub-lic sector funding. According to WHOestimates, in 2005 total health expenditurewas 6.6% of Gross Domestic Product(GDP), of which 5% was public sector ex-penditure on health. By contrast, WHOestimated that total health expenditure inthe Russian Federation was 5.2% of GDPin 2005, of which 3.2% was public sectorexpenditure.5

Future primary care reform challenges centre on attracting and retaining the beststaff; raising prestige; and improving thegatekeeping function of doctors working inprimary care. There are ongoing problemsin rural areas in attracting and retaininghealth care personnel. The shortage of primary care doctors in Belarus, despiteextremely high rates of physicians percapita nationally, is one of the most acuteproblems in the health care system. Inmany respects, the introduction of generalpractice to rural regions was a response tothe realities of the situation – primaryhealth care doctors in understaffed prac-tices were working alone treating bothadults and children, irrespective of theirtraining as either paediatricians or interniststreating adults.

One measure to address this shortage hasbeen the reintroduction of compulsoryplacements in primary care settings for allnew graduate doctors from 2007. Salariesfor doctors working in primary care havealso been boosted by 40%, but workingconditions are still very challenging. Themain expansion in primary care in Belarushas been in the workload of primary caredoctors, particularly the need to fulfil alarge number of routine annual check-ups,that in many cases has to be conducted byfour to five narrow specialists (ENT, neu-rologist, surgeon, ophthalmologist). Thesecheck-ups involve extensive paper workand cover large segments of the popula-tion (e.g. all school children twice a year,chronically ill patients, women of repro-ductive age). Primary care doctors also areresponsible for carrying out annual fluorography screening for tuberculosis,opportunistic screening (particularly forcancers) and all sick leave authorisations.All these practices contribute to the extremely high number of out-patient contacts in Belarus, which increased to 13.6per person per year in 2007.5

There has been little success thus far inraising the prestige of primary health carein order to attract more young doctors. In-deed, compulsory placements in primarycare could serve to reinforce the idea thatworking in primary care is not somethingto be embraced as an active career choice.The low prestige of general practice andprimary care services is also one reasonwhy the traditional polyclinic system withcommunity specialists has been maintainedin the cities. However the polyclinics inthe big cities are also understaffed and facethe constant drain of primary care doctorsto the specialist and hospital sectors, and in

many cases out of the medical profession.

Patients prefer the traditional polyclinicsand would rather consult a specialist thanan internist or general practitioner [6]. Pa-tients prefer to self-refer to specialists whenthey are ill, as is their constitutional right,and the weak gate keeping role of primarycare doctors mean that there is a consider-able over-utilisation of inpatient care. Thefact that such rights are enshrined in theconstitution makes it especially challengingto change the status quo in urban areas; in rural areas, it is only the geographicaldistance from specialist services which reinforces the gate keeping role of primarycare doctors. Nevertheless, the ongoing development of a new two-year nationalhealth strategy provides the Belarusiangovernment with a good opportunity todefine a clear vision for the future of pri-mary care in Belarus.

REFERENCES

1. Richardson E, Boerma W, MalakhovaI, Rusovich V, Fomenko A. Belarus:Health system review. Health Systems inTransition 2009;10(6):1–118.

2. Atun RA. What are the advantagesand disadvantages of restructuring ahealth care system to be more focussed onprimary care services? Copenhagen:World Health Organization, Health Evidence Network, 2004.

3. Saltman RB. Drawing the strands to-gether: primary care in perspective. In:Saltman RB, Rico A, Boerma W (eds).Primary Care in the Driver’s Seat? Organisational Reform in European Primary Care. Maidenhead: Open University Press, 2006.

4. Zharko V. Ob itogakh raboty organov iuchrezhdenii zdravoohraneniya v 2006godu i osnovnyh napravleniyah deyatel-nosti na 2007 god [On the results ofhealth care system bodies and agencieswork in 2006 and main activity directionsfor 2007]. Voprosy Organizatsii i Informatizatsii Zdravookhraneniya 2007;1:4–14.

5. World Health Organization. Healthfor All Database. Copenhagen: WorldHealth Organization Regional Office forEurope, January 2009.

6. Egorov K, Boerma W, Rusovich V,Schellevis F, Abrahamse H. How do Belarusian citizens see primary care? Results from a national survey in 2005.Utrecht: NIVEL, 2006.


SNAPSHOTS


SNAPSHOTS

In Poland, major restructuring of healthcare facilities started in the early 1990s,when a law on health care units was intro-duced. By virtue of this law, health careinstitutions have been separated into twolegal structures: public but autonomous‘SPZOZs’ and non-public NZOZs.

Prior to the introduction of this legislationpublic health care units had been operatingas, ‘budgetary units’, fully owned and dependent on their public ‘mother admin-istration’. However, this form of operationhad been considered ineffective, with bur-geoning bureaucracy and debts, whilst delivering poor patient services, leading tothe decision to make all public health careunits autonomous units (SPZOZs).

Since 1995 the new public health care unitswere established at different public admin-istrative levels (municipal, county, regionalor central) and the non-public units byother private sector bodies, including foun-dations.

Instability and insolvency protectionStructures have been changing gradually.1

Formally, one key difference between theold budgetary units and the new SPZOZsis that the latter are registered in a dedicatedchapter of the national legal register andhave a similar legal status to companies andfoundations. However, unlike other legalentities on this register, SPZOZs are protected from bankruptcy. They are autonomous in management but should financial difficulties arise, liability rests

with the public authorities. This guaranteewas intentionally introduced in the 1990s,as Parliament wanted to prevent the suddencollapse of health care facilities consideredimportant for the maintenance of publichealth.

In subsequent years of operation, it became obvious that, while this mecha-nism protected these health care facilities, ithampered their business partners, such asmedical and fuel suppliers. Moreover, man-agers of the SPZOZs, aware of their specialposition, often spent more than their units’revenues permitted for, increasing the levelof debt. Despite governmental efforts toclear and restructure hospital debts, manySPZOZs have continued to build updeficits. In the period since 1998, the statespent more than €3 billion (12 billion Zlo-tys (PLN)) on debt bailouts. In 2008 alonecumulative debt amounted to €1.5 billion,compared to a total health budget of ap-proximately €14 billion (50 billion PLN).

Without appropriate incentives to controlcosts, the SPZOZs threaten to seriouslydestabilise the finances of local adminis-trations. In this respect, it appears to beabsolutely necessary to undertake furtheraction. It is worth noting, however, thatthe distribution of debt is uneven; 80% ofthe accounts payable by SPZOZs weregenerated by 10% of the units. Of 1,730units examined by the Ministry of Health,828 did not have any outstanding debts(47.9% of all SPZOZs surveyed).

Privatisation Since the 1990s privatisation has been undertaken, to a large extent, in the ambu-latory care sector, and today the majorityof ambulatory health care providers havebeen converted into NZOZs. It was com-monly perceived that private ownership ofambulatory care results in better care, moreflexibility and more dedication of providersto maintain good relationships with theirpatients. Privatisation has not limited ac-

cess to public services, as private providershave been fully integrated into the publichealth care system and largely operate onthe same principles. Moreover, privatisa-tion of ambulatory care has not been linkedwith any significant sale of property: localadministrations continue to own proper-ties, renting space to companies staffed byformer SPZOZ employees.

The beginning of the new millenniummarked the first attempt to ‘restructure’hospitals by changing their legal structure.Unlike ambulatory health care, the major-ity of the population has remained suspicious of the privatisation of hospitals.The process of privatisation in general, letalone hospital privatisation, has had littlesupport.

Nonetheless by the end of 2006, there wereapproximately 150 hospitals run asNZOZs, including fifty established bycompanies owned by local governments.These latter entities were established, inmost cases, as a result of ‘closing down’ thepublic facility (SPZOZ) and creatingNZOZs established by a company andowned partially or fully by local govern-ment.

From the legal perspective, these new entities were ‘non-public’, established bylimited liability companies. However, sincethe shares are mostly owned by local authorities, it is difficult to talk of privati-sation in this context and the term ‘non-public health care institution’ does not really apply.

All hospitals owned by companies run bylocal governments are contracted by theNational Health Fund and their scope ofservices is similar to the previous SPZOZs.This seemingly obvious statement is im-portant because, in the eyes of the public(and indeed that of some political forces), achange in the legal status to ‘non-public’ issynonymous with ‘payment for services’.This is, of course, untrue. Only a handful

Poland: will legal restructuring affectthe (real) economy of hospitals?

Adam Kozierkiewicz

Adam Kozierkiewicz is an independentconsultant and co-author of the recentreport Koło ratunkowe dla szpitali: Oddo�swiadcze�n do modelu restrukturyzacji[Lifebuoy for hospitals: for experience toa recipe for restructuring] commissionedby the European Investment Bank in2007. Email: [email protected]


of the fifty restructured hospitals encoun-tered difficulties after the change and mostexperienced an improvement in their fi-nancial and management situations.

Following the initial success of restructur-ing, the government was inspired to pushfor a universal change of status in hospitalsfrom SPZOZ to NZOZ. In 2008 the gov-ernment formulated a programme, initiallyproposed as a law, which required each SPZOZ to transform itself into a companyowned by the local community.

Governmental plans had scheduled this tobe completed by the end of 2010. However,the obligatory nature of the process andtight timeframes were major reasons forpolitical opposition to the proposal. Accompanied by populist rhetoric, callingfor “state responsibility for citizens’health”, this opposition was strong enoughto force the President to veto the law.

In these circumstances the government undertook steps to encourage hospitals tochange by using financial incentives, in-cluding debt bailouts and special creditlines for investments. According to veryconservative estimates, at least seventy hos-pitals (of 650), will respond positively tothis offer. Many more are however likely towait for even more generous offers fromfuture governments.

The reform of health care facilities inPoland has hardly begun. We face furtherchallenges and are likely to see more ex-tensive liberalisation of markets in healthcare. Opposition to this reform, coupledwith the traditional budgetary attitude ofhealth care decision makers, remainsstrong, and this will exclude and isolatemany units. Another round of changes isexpected in the next few years, when thegovernment will be even more pressed byfinancial crises within the sector.

REFERENCES

1. Kozierkiewicz A. Koło ratunkowe dlaszpitali. Od do�swiadcze�n do modelu restrukturyzacji. [Lifebuoy for hospitals.From experience to a recipe for restructuring]. Poznan: Termedia, 2008.


SNAPSHOTS

Italy’s new fiscal federalism

George France

In May 2009, Italy's Parliament approvedLaw 42 which sets down the broad elements of the new fiscal federalism whichthe national government intends to intro-duce over the medium term. “Fiscal feder-alism” is concerned with the working ofthe arrangements used to govern the financial relations of different levels of gov-ernment.1 Under the new fiscal federalism,sub-central governments will enjoy a sub-stantial increase in financial autonomy withthe aim of securing a closer match betweentheir spending powers and their tax rev-enues. This will consist, in the main, of thenational government ceding pre-specifiedguaranteed shares of the revenues raisedwithin the territory of a region from na-tional value added tax and national incometax. Law 42 also changes how the State’scontribution to each region’s spendingneeds in the health care sector is to be calculated.

Funding and expenditure mismatchAs devolution has proceeded over the yearsin Italy, a mismatch has emerged as sub-central governments acquired independ-ence in administration and organisation ata faster rate than they did the authority toraise the financial resources to finance these.For example, on average own-revenuesources have provided 38% of total regionalrevenues, ranging from 56% for the richernorthern regions to 26% for the poorersouthern regions.2 This ‘skewness’ betweenspending and revenue powers has contributed to the creation of a problem ofaccountability and a record of intergovern-mental strife. The process of devolution ismost advanced in the public health caresector; 70% of the total regional budgetgoes on health care and the regions manage90% of total public expenditure on healthcare. The sector has been characterised bychronic deficits, with the regions regularlyspending more than the annual funding

allocation they receive from the State.

This accountability problem was aggra-vated by a constitutional amendment in2001 whereby the regions were required toguarantee to all residents a health care en-titlement (specified in the form of positiveand negative lists of services). The aim hereis to protect the ‘national interest’ in health(defined in terms of universal, comprehen-sive and financially accessible care), whichit is feared is threatened by the centrifugalforces set in motion by devolution. Thisentitlement is defined centrally in consul-tation with the regions, but it is the Statewhich has to ensure that all the regionshave the financial means necessary to de-liver it.

The problem is that the regions, in theknowledge that the State is obliged to guar-antee them funding for the entitlement,have had an incentive to spend more thanmay be strictly necessary or at least to beless than fully zealous in trying to livewithin their annual funding allocations:spendthrifts may have been rewarded atthe expense of the more frugal.

All this has spurred the central government,faced with the constraint of meeting its ob-ligations in respect of European MonetaryUnion regarding aggregate levels of publicexpenditure and public debt, to apply meas-ures deliberately aimed at curtailing the autonomy of those regions revealed to beserial deficit spenders. For example, thecentral government has begun to requirethat regions with budgetary difficulties introduce new and/or increase patient co-payments and regional taxes. This is caus-ing anxiety about geographical equity.

Moreover, since such central interventionmeans in effect backtracking on the devo-lution design, at least for the regions involved, it could have political costs forthe national government. The intention ofParliament now is that, being granted ex-panded tax revenue sources, the regionswill be more inclined to live within theirmeans and be more accountable for theiractions to both their regional electorateand the national government.

George France is based at the Institute forthe Study of Regionalism, Federalism andSelf-Government, Consiglio Nazionaledelle Ricerche, Rome. Email: [email protected]


Standard cost approachThe way the cost of delivering the healthcare entitlement is calculated has also madeit difficult for the State to refuse tout courtto finance regional deficits. Up until now,the annual aggregate contribution by thecentral administration to aggregate publichealth care spending has been officially setas a percentage of Gross Domestic Product(GDP) and divided among the regions onthe basis of the weighted population.

Under the new fiscal federalism the Statescontribution to regional health care costswill be calculated principally using stan-dard costs. This could help to reduce thechronic regional deficits until now coveredin part by supplementary State fundinggranted ex post.

Data for 2007 give a difference of €6 billionbetween planned expenditure and the effective cost of financing the entitlement,an overshoot of 8%.3 There are large dif-ferences between individual regions in thisregard; it is calculated that seven regions accounted for over 80% of total overspendin the period 2000–2005.4 This overshoot,according to the Court of Accounts, thenational body responsible for auditing thepublic accounts, represents the sum of underestimated spending needs and thecosts of operating inefficiency.

One estimate of what might be called the‘inefficiency burden’ is €2.2 billion.3 Thismeasure is obtained by comparing what alltwenty-one regions actually spent in deliv-ering the health care entitlement with whatthey would have spent had their costs beensimilar to those of the four regions with thebest record of efficiency and quality ofcare, but with quite different organisationaland administrative arrangements. Anotherstudy, based on the costs of two regions,widely claimed in government circles tohave the ‘best performance’, calculates theaggregate ‘inefficiency burden’ to be €4.3billion.5 With the reform, the State’s con-tribution to the regions would be cappedusing the standard costs of delivering theentitlement.

The principal source of data for estimatingstandard financial needs is the Sistema Informativo Sanitario (SIS – Health CareInformation System), which collects dataon services and costs at facility level fromall the regions using a common methodol-ogy nation-wide. The SIS is being revisedon the basis of the results of the so-called‘Progetto Mattone’ (loosely translated asthe Brick-upon-Brick Project), a major col-laborative effort between the Ministry of

Health and the regions. The aim is to gen-erate for all the regions comparable datawhich emphasises efficiency, quality andappropriateness for all the regions. How-ever, the SIS still has a long way to go be-fore it will furnish reliable comprehensivedata, including that on services contained inthe national entitlement.

The standard cost approach required bythe new law will have to be used with cau-tion. Standard cost is not minimum cost –contrary to what seems to be assumed withthe inefficiency burden estimates citedabove; rather it is the cost of efficientlyproviding the entitlement.

While many studies report important in-terregional differences in efficiency, cur-rent variability between regions in the coststo deliver the entitlement to their citizenscannot be explained solely in terms of effi-ciency. For example, both the regions usedto calculate the inefficiency burden of €4.3billion cited above have younger popula-tions and are richer and so tend to makeless use of health services in absolute termsand, when they need care, to go more oftento the private health sector.6 The two re-gions also happen to be relatively efficient.In addition, a recent investigation of theperformance of regional health systemshighlights important differences among re-gions in their governance capability andthis seems to have a direct impact on thecost and quality of services provided.7

These are all reasons why the Ministry ofHealth will have to work long and hard atconvincing and assisting the regions to pro-vide reliable and methodologically uniformdata on the costs and activities of their staffand facilities and those of private contrac-tors which take maximum account of qual-ity and appropriateness. Perhaps one ofthe most serious obstacles to calculatingstandard costs is the fact that quite a num-ber of the regions furnish data which fail to

meet SIS criteria, a situation likely to per-sist for quite some time. However, Law 42on the new fiscal federalism does go in theright direction when it moves standardcosts to centre stage.

REFERENCES

1. Oates W. An essay on fiscal federalism.Journal of Economic Literature1999;37:1120–49.

2. Buglione E. La finanza [Finance]. In ISSIRFA-CNR (ed), Quarto Rapporto Annuale sullo Stato del Regionalismo inItalia [Fourth Annual Report on the Stateof Regionalism in Italy]. Milan: Giuffrè,2007.

3. Corte dei Conti. Elementi perl’Audizione sul Disegno di Legge in Mate-ria di Federalismo Fiscale in Attuazionedell’Articolo 119 della Costituzione. [Issuesfor the Hearing on the Bill for Fiscal Fed-eralism in Application of Article 119 of theConstitution]. Commissione Riunite AffariCostituzionale, Bilancio, Finanze e Tesoro:Riquadro 2., Senate, 17 November 2008.

4. Arcangeli L, De Vincenti C. La politicasanitaria [Health policy]. In: Guerra MC,Zanardi A (eds). La Finanza Pubblica Italiana – Rapporto 2008 [Italian Public Finances – 2008 Report]. Bologna: IlMulino, 2008.

5. Bartoloni M. Con il federalismo SSN adieta. [With federalism the SSN goes on adiet]. Il Sole- 24 Ore Sanità, 25 November – 1 December 2008.

6. Mapelli V. Equivoci da costi standard[The Pitfalls of Standard Costs]. La Voce,28 November 2008. Available athttp://www.lavoce.info/articoli/pagina1000785.html

7. Mapelli V (ed). I Sistemi di Governancedei Servizi Sanitari Regionali [The Systemof Governance of Regional Health Services]. Roma: Formez, Quaderni, n. 57,2007. Available at http://sanita.formez.it/


SNAPSHOTS

Health Systems in Transition (HiT) profiles are country-based reports thatprovide a detailed description of ahealth system and of policy initiativesin progress or under development.HiTs examine different approaches tothe organisation, financing and deliv-ery of health services and the role ofthe main actors in health systems; describe the institutional framework,process, content and implementationof health and health care policies; andhighlight challenges and areas that require more in-depth analysis.

Slovenia Health System ReviewJune 2009

Tit Albreht

Eva Turk

Martin Toth

Jakob Ceglar

Stane Marn

Radivoje Pribakovic

Brinovec Marco Schäfer

Available at http://www.euro.who.int/Document/E92607.pdf

http://www.lavoce.info/articoli/pagina1000785.html

http://sanita.formez.it/

http://www.euro.who.int/Document/E92607.pdf


PUBLIC HEALTH PERSPECTIVES

The increase in avoidable chronic diseasessuch as heart disease, stroke, diabetes, obe-sity and cancer is having a serious impacton quality of life across Europe. With fore-casts showing skyrocketing obesity levelsin the coming decades, along with increasesin linked avoidable chronic diseases amongyounger generations, the cost of treatingthese diseases is likely to overwhelm healthsystems and negatively impact on eco-nomic growth if current trends are not reversed.

The Foresight report on Tackling Obesities,published in October 2007 in the UnitedKingdom, mapped the complex drivers ofthe obesity epidemic and demonstrated thehealth and economic impact if the risingrates of obesity are not reversed.1 The re-port also highlighted similarities betweenthe challenges of obesity and climatechange: both require systemic culturalchange, across government sectors andthroughout society. In fact some of theproposed actions to address obesity, suchas increasing physical activity by encour-

aging active travel, may also help to ad-dress climate change by reducing carbonemissions.

Sustainable economic development andlong-term economic growth are only pos-sible if both environmental and health im-pacts are considered in all government poli-cies. Impact assessments are an importanttool to help make this goal a reality, but inpractice health impact assessments (HIA)tend to be under-utilised, particularly incomparison to environmental impact as-sessments, and their results often over-looked. This is in part due to the fact thatthe European Commission has establishedformal requirements for Member States tocarry out environmental impact assess-ments and strategic environmental assess-ments, while no similar requirement existsfor health impact assessments. Increasingthe usage of health impact assessments atthe European Commission and MemberState level is one important strategy to in-corporate health into all policies and reducethe growing rates of chronic disease.

Including health in all policies is a neces-sity to improve health and well-beingTackling Obesities illustrated what the pub-lic health community already knows,

namely that many of the factors impactingon health and well-being stem from sectorsexternal to health, such as planning andtransport, food, the environment and fiscalpolicy. In order to improve health andwell-being, and stem the rising tide ofchronic illnesses, health impacts must beconsidered in all policies, by all govern-ment departments.

HIA is a tool to determine the health ef-fects of a policy, programme or project,and the distribution of those effects withinthe population.2 It can help policy makersgauge the impact of decisions on health, en-sure coordinated cross-government action,and meet the goal of health in all policies.Council Conclusions on Health in AllPolicies issued at the close of the Finnishpresidency (June–December 2006) citedArticle 152 and called on the EuropeanCommission (EC), Member States and theEuropean Parliament “to ensure the visi-bility and value of health in the develop-ment of EU legislation and policiesby…health impact assessments”.3 The 2007EU Health Strategy also called for the useof HIA to strengthen the integration ofhealth in all policies, which is one of thestrategy’s four fundamental principles.4

The WHO Commission on the Social

Increasing the use of healthimpact assessments:

Is the environment a model?

Rebecca Salay and Paul Lincoln

Summary: Increased rates of chronic illnesses will overwhelm health systems andnegatively impact economic growth if current trends are not reversed. Healthimpact assessment (HIA) helps policymakers gauge the impact of decisions onhealth, ensure coordinated cross-government action and meet the goal of healthin all policies. HIAs are under-utilised at the European Commission and are nota mandatory requirement for Member States in the same way as environmentalimpact assessments. This paper, which is part of a longer report by the NationalHeart Forum, analyses the position of health and environmental impact assessments and sets out an agenda for policy development to ensure that healthimpacts are assessed as regularly and thoroughly as environmental impacts.

Keywords: health impact assessment, environmental policy, Europe

Rebecca Salay is Policy Researcher andPaul Lincoln, Chief Executive, NationalHeart Forum, London, United Kingdom.Email: [email protected]


Determinants of Health report, Closingthe Gap in a Generation, also recommendsthat regular health equity impact assess-ments be institutionalised in national andinternational policymaking.5

Health impacts not fully considered bythe EC The EC has a rigorous system of integratedimpact assessment, but in practice publichealth implications are not fully consid-ered outside the health sector. The result ismany EU policies have negative unin-tended impacts on health. Integrated im-pact assessments cover such a large numberof issues that health, considered as a part ofoverall “social impacts,” is often over-looked while other top-line issues, moreeasily expressed in economic terms, areemphasised. An internal review by theUK’s National Heart Forum (NHF) foundthat in 2005 and 2006 73 out of 137 impactassessments carried out by the Commis-sion did not mention the world ‘health,’ either in regard to health systems or pub-lic health.

While there is still a long way to go to fullyaddress the challenge of climate change,the environmental movement has success-fully mainstreamed environmental concerns into government decisions andenvironmental impact assessments are car-ried out on a more regular basis than HIA.This difference comes despite similar lan-guage in the EU Treaty regarding the EU’sobligations toward protecting humanhealth and the environment.

Although Member States have the ultimateresponsibility for health, Article 152 of theAmsterdam Treaty explicitly states “a highlevel of human health protection shall beensured in the definition and implementa-tion of all Community policies and activi-ties.” The Treaty also states that Commu-nity policy should “contribute to thepreservation, protection and improvementof the quality of the environment.” Thatobligation is strengthened by the Direc-tive on Environmental Impact Assess-ments6 (EIAs) and the Strategic Environ-mental Assessment (SEA) Directive,7

which establish a legal obligation for Mem-ber States to carry out environmental im-pact assessments. Currently there is no legal obligation to carry out an HIA ei-ther at Member State or EU level.

The NHF’s research found several otherimpediments to HIAs being regularly car-ried out at the European Commission.Each Directorate General (DG) has thediscretion to decide which of their

proposals requires an impact assessmentand how it will be designed and organised.These decisions are seldom challenged byother DGs. For example, if DG Agricul-ture decides there is no need for a healthimpact assessment on the Common Agri-cultural Policy (CAP), then that decision islikely to stand with no input from otherDGs or stakeholders.

It is also unclear how much core compe-tence the European Commission, Parlia-ment and Council have in this area, both interms of carrying out HIAs and knowingwhat questions to ask when reviewing im-pact assessments. Anecdotal evidence indi-cates that DG Health and Consumers maynot have the capacity to contribute whenasked to assist another DG in impact as-sessment. DG Health and Consumersneeds to have staff with the time and theexpertise to understand, for example, theimpact of agricultural or transport policyon health. Without it those issues may gounaddressed, despite the fact they directlyimpact on risk factors for chronic disease.

Agriculture and transport policies impacton healthAgriculture and transport are just two ex-amples of sectors which impact on thehealth of people throughout the EuropeanUnion, but where health impacts are notfully considered. Agricultural policy af-fects the type and price of food availablefor consumers, and the CAP provides anopportunity to target investment to im-prove nutrition. Currently, relatively smallamounts of CAP funding subsidise fruitand vegetable production, while dairy sub-sidies promote production and consump-tion of products high in saturated fats. TheSwedish Public Health Institute has lookedat the health implications of the CAP, butthe EC has never commissioned an HIA onthe CAP. If they did, one might find thatinvestment in fruit and vegetable produc-tion should be increased, with subsidiesused to make them more affordable, or thatincentives should encourage production oflow-fat rather than full-fat milk.

Transport policy is another area which di-rectly impacts on health. Shifting transportpriorities to favour walking and cyclingwould increase physical activity levels, re-duce congestion and air pollution, and helpaddress climate change. In September 2007the EC published a Green Paper on urbanmobility. Promotion of walking and cy-cling is discussed in the context of sustain-ability, but health benefits must be fullyassessed and weighed against other costs

and benefits before the final action plan isdrawn up.

Proposals to increase the use of HIAWhat are the steps policymakers need totake to improve the current process of im-pact assessment and include health in allpolicies? Firstly enabling legislation mustbe passed to create a legal obligation forHIA which mirrors that for SEA and EIA.The directives for EIA and SEA give legalforce to the treaty obligation to protect theenvironment, and could serve as a model tocreate a legal obligation to carry out anHIA either at the Member State or EClevel. Outside Europe, Thailand has set astrong example in enshrining HIA into lawin 2007. Citizens have the right to demandthat an HIA be conducted, and to partici-pate in the process, while the 2007 Thaiconstitution also includes strong provi-sions on HIA.

Secondly, Article 152 should be strength-ened to require HIAs on all major propos-als. Conducting an HIA on every Com-mission policy would be prohibitive interms of cost and staff resources, but sig-nificant policies should be required to fullyaddress health either in a separate HIA orwithin the integrated impact assessment.A potential model operates in England,where policy makers must answer threescreening questions relating to impacts onhealth services, health determinants, andlifestyle related risk factors, to establishwhether a full HIA is required.

Thirdly, the EU Health Strategy shouldrequire HIA on major proposals and spec-ify the need for public health-focused impact assessments. Finally, DGs should beprovided with sufficient resources, includ-ing staff training, to allow them to appro-priately carry out impact assessments andto contribute expertise to impact assess-ments in other DGs. The European Parlia-ment and Council should also develop staff expertise in HIA and ensure they are undertaken.

The World Health Organization and others have recognised that includinghealth in SEAs can be an effective strategyto address health impacts without a sepa-rate HIA. Protection of human health is included in the SEA directive but MemberStates have the flexibility to broaden thescope to include health promotion. In England the Department of Health is developing guidance to include a broad interpretation of human health in SEAsand ensure health impacts are addressedearly in the planning process. Again, this





could serve as a model for Member States.

Many Member States are acting on theirown to institutionalise HIAs, but develop-ment differs across Europe and leadershipis needed at the highest level. Public healthadvocates should work with future presi-dencies to continue the emphasis on healthin all policies. In the absence of politicalleadership, the National Heart Forum be-lieves that one strategy is to find the rightpartnership to take on a legal challenge toclarify the EU’s obligation about conduct-ing HIAs.

Health, sustainable development and eco-nomic growth are inextricably linked.Without a focus on health and sustainabil-ity that is integrated throughout all gov-ernment departments, increasing rates ofavoidable chronic illnesses will overwhelmhealth systems throughout the EU andlimit economic growth. In particular re-form of the CAP, which consumes nearlyhalf of the EU budget, should not moveforward without a comprehensive under-standing of its impact on health. The EU’scontribution to public health will only be

fully realised if HIAs are made a manda-tory core activity of the Commission –otherwise public health will continue to bea hit and miss, marginal consideration.

This article is based on a text which appeared in the Lancet (2008;372:860–61).For the full National Heart Forum reporton health impact assessment, please visithttp://www.heartforum.org.uk/Publications_NHFreports.aspx

REFERENCES

1. Butland B, Jebb S, Kopelman P et al.Foresight. Tackling Obesities: Futurechoices – project report. London: Government Office for Science, 2006.Available at http://www.foresight.gov.uk/Obesity/17.pdf

2. European Centre for Health Policy.Health Impact Assessment: Main conceptsand suggested approach. Gothenburg consensus paper. Brussels: European Centrefor Health Policy, 1999. Available athttp://www.euro.who.int/document/pae/gothenburgpaper.pdf

3. Council of the European Union. Council Conclusions on Health in AllPolicies. Brussels: Council of the EuropeanUnion, December 2006. Available athttp://tinyurl.com/kwhcsq

4. European Commission Staff WorkingDocument: Together for Health: A Strategic Approach for the EU 2008–2013,SEC(2007) 1376, 23 October 2007.

5. Commission on Social Determinants ofHealth. Closing the gap in a generation:health equity through action on the socialdeterminants of health. Final Report of theCommission on Social Determinants ofHealth. Geneva: World Health Organization, 2008. Available athttp://www.who.int/social_determinants/thecommission/finalreport/en/index.html

6. Council Directive 85/337/EEC of 27June 1985, Official Journal L 175,05/07/1985 P. 0040–0048.

7. Directive 2001/42/EC of the EuropeanParliament and of the Council of 27 June2001, Official Journal L 197, 21/07/2001 P.0030–0037.

Edited by Peter C. Smith, Elias Mossialos, Irene Papanicolas, Sheila Leatherman

In a world where there is increasing demand for theperformance of health providers to be measured,there is a need for a more strategic vision of therole that performance measurement can play insecuring health system improvement. PerformanceMeasurement for Health System Improvementarticulates such a vision and it marshals theevidence of how to go about this in practice.

Leading authorities in the field aim to present technical material in an accessible way and illustrate with examples from all over the world.Presenting opportunities and challenges associated with performance measurement itexamines the various levels at which health system performance is undertaken, the technicalinstruments and tools available, and the implications using these may have for thosecharged with the governance of the health system.Many chapters also highlight government’s crucialrole in guiding performance measurement policyand the numerous political considerations thatmust be examined alongside technical measurement issues.

Cambridge University Press,2009

ISBN 978-0-521-11676-3Hardback

ISBN 978-0-521-13348-7Paperback

Performance Measurement for Health System Improvement: Experiences, challenges and prospects

Contents: Introduction; Population Health;Patient-Reported Outcome Measuresand Performance Measurement;Measuring Clinical Quality and Appro-priateness; Measuring FinancialProtection in Health; Heath SystemResponsiveness; Measuring Equity ofAccess to Health Care; Health SystemProductivity and Efficiency; RiskAdjustment for Performance Measurement; Clinical Surveillanceand Patient Safety; Attribution andCausality in Health-Care PerformanceMeasurement; Using Composite Indicators to Measure Performance inHealth Care; Primary Care; ChronicCare; Mental Health Services; Long-term Care Quality Monitoringusing the inteRAI Common ClinicalAssessment Language; Targets andPerformance Measurement; PublicPerformance Reporting on QualityInformation; Developing InformationTechnology Capacity for PerformanceMeasurement; Incentives for Health-care Performance Improvement;Performance Measurement andProfessional Improvement; Interna-tional Health System Comparisons:from Measurement Challenge toManagement Tool; Conclusions.

http://www.heartforum.org.uk/Publications_NHFreports.aspx

http://www.foresight.gov.uk/Obesity/17.pdf

http://www.euro.who.int/document/pae/gothenburgpaper.pdf

http://tinyurl.com/kwhcsq

http://www.who.int/social_determinants/thecommission/finalreport/en/index.html


PALLIATIVE CARE

The European Parliament has recentlypublished an external report, PalliativeCare in the European Union.1 As the mainresearchers in this endeavour, we examinethe unique nature of the palliative carefield, including the important role of multi-disciplinary teams, psycho-social care, vol-unteers, palliative care training for generalpractitioners (GPs) and other specialists,and the challenges faced by patients withterminal illnesses. Delving into the indi-vidual palliative care structures among Eu-ropean countries, we found a pronouncedheterogeneity in the way in which nationalhealth systems care for their dying, as wellas the quality and access of the care pro-vided, not only between countries, but alsowithin them. The report concludes with awide variety of policy options which areintended to present ideas, stir debate andstimulate creative proposals among deci-sion-makers in their efforts to improve the

care offered to patients at the end of theirlives.

The study was, in part, conceived as a fol-low up to the Recommendation Rec (2003)24 of the Committee of Ministers to Mem-ber States on the organisation of palliativecare. That initiative, the most ambitious todate, made recommendations for palliativecare development in the fifteen countriesthen making up the European Union. Thenext four years brought the expansion ofthe EU to its current twenty-seven coun-tries, as well as advances in the palliativecare field across the continent. These dynamic changes spurred the EuropeanParliament Committee on Environment,Public Health and Food Safety to issue aclosed invitation to tender in October 2007for a new external study on palliative carein Europe, to be managed by the Economicand Scientific Policy Department.

The following December, one of us (Jose MMartin-Moreno, a medical doctor and pub-lic health specialist) was commissioned tolead the investigation. He assembled amulti-disciplinary team which includedspecialists in palliative medicine with ex-tensive experience in comparative pallia-tive care studies and an expert in healthsystem economics. We also had the supportand active participation of the EuropeanAssociation For Palliative Care (EAPC)through its president, Dr Lukas Radbruch,and other expert members. The EAPCproved to be a crucial partner in the initia-tive, as information was freely and colle-gially exchanged with the mutual objec-tive of contributing at a policy level to theimprovement of patient care.

Study objectivesThe proposal to the European Parliamentfitted closely to its stated wishes, with anincreased focus on the elements character-ising the palliative care field (see Box 1)and a brief description of the situation in the twenty-seven EU countries. A standard template was used in the countryprofiles to facilitate comparison, and anoriginal and complex ranking system was formulated with information from theEAPC in order to measure the relativeprogress and vitality of each country’s palliative care structures.

Transforming research into action:A European Parliament report on palliative care

Jose M Martin-Moreno, Meggan Harris, Lydia Gorgojo, David Clark,Charles Normand and Carlos Centeno

Summary: The authors of a European Parliament report on palliative caresummarise the process of the five-month investigation, as well as the real andpotential results of the study. Engaging a large number of national and international stakeholders, including ministries of health, national palliative careassociations and the European Association for Palliative Care (EAPC), we wereable to draw on a well of previous research and diverse experiences before formulating operative policy options for the EU and its Member States. While thereport itself fomented some self-examination in the countries studied, its fullexploitation by palliative care advocates is still pending.

Key words: palliative care, Europe, European Parliament, health systems, healthpolicy and management

Jose M Martin-Moreno is Professor of Public Health, Meggan Harris Research Assistantand Lydia Gorgojo Research Associate at the Medical School and University ClinicalHospital, University of Valencia, Spain. David Clark is Director of the InternationalObservatory on End of Life Care, Lancaster University, United Kingdom & VisitingProfessor of Hospice Studies, University College Dublin and Trinity College, Dublin,Ireland. Charles Normand is Edward Kennedy Professor of Health Policy &Management, Trinity College, Dublin, Ireland. Carlos Centeno is Chair, European Association of Palliative Care Task Force on the Development of Palliative Care inEurope, University of Navarra Clinic, Pamplona, Spain. Email: [email protected]


MethodologyDue to the short time frame for the study(five months), the limited space requestedby the European Parliament (fifty pages)and the broad scope and impact of thestudy, conciseness and efficiency were asimportant as up-to-date accuracy. With thisin mind, the research team took three stepsthat simultaneously maximised efficiencyand enriched the final text.

First, a comprehensive search of scientificand grey literature was surveyed. Synthe-sising and analysing this information, wewere able to depict a relatively accuratepicture of the situation in European coun-tries, as well as describing some of the keyareas of assessment. A few of the principalsources used in this endeavour, especiallyfor the country profiles, were the EAPCAtlas of Palliative Care in Europe,2 Help-ing People at the End of their Lives3 andTransitions in End of Life Care.4 This re-search also helped identify national policieswhich have already been proven successfulin improving quality of life for Europeanpatients; these positive national experiencesare the backbone of the policy options atthe end of the report.

In order to update the secondary data gath-ered, we directly contacted all ministries ofhealth and palliative care organisationsthroughout the EU to obtain primary dataon the organisation of palliative care in theircountries. After two rounds of contact let-ters and emails, nearly forty responses werereceived from twenty-six European coun-tries, allowing us to update our findingswith current figures and developments.These reflected the vitality of the palliativecare field and also highlighted the need forregular comparative studies to document

the achievements. Although the EAPC At-las was published with data from 2006, ourcontacts with national stakeholders showedthat much progress and many changes hadoccurred in the following two years.

Interestingly, the responses received fromhealth authorities in many countries withlittle palliative care development were quitecandid, acknowledging that palliative carehad received little attention in their healthsystem but also recognising its importance.This circumstance suggests the pro-activeeffect that this type of report can stir, stim-ulating national policy-makers to considerbringing a palliative care agenda to the table.The involvement also provided the oppor-tunity for health authorities to explain thestrengths and weaknesses of their nationalmodel, as well as allowing for palliative careassociations to express their ideas, frustra-tions and successes.

Finally, a number of European specialistswere invited to make special contributionsto the final text, detailing their area of expertise and the pending challenges totackle. They included Franca Benini (paediatric palliative care), Marilène Fil-bert (GP training), Phillip Larkin (nursetraining), Inmaculada Martín-Sierra (socialwork), Marina Martínez (psychologisttraining), David Oliviere (volunteers),Lukas Radbruch (quality assurance andbest practices), Stein Kaasa (research) andLuzia Travado (psychological support).Channeling these contributions into abroader public health-based approach, weaimed to synergise solid research evidencewith operational health system policies.

Findings The wide participation in the formulationof this document ensured that the conclu-sions truly reflected the diversity, but alsothe inequalities, of the European reality.Palliative care structures vary widely, asdifferent cultures deal with death in differ-ent ways. England is the cradle of the ‘hos-pice’, while France initially developed services in hospitals. Other countries, suchas Ireland and Hungary, concentrate theirresources on providing home-care teams,whereas Belgium and the Netherlands areincreasingly investing in day centres andnursing homes. Grassroots movementshave been responsible for palliative caredevelopment in Poland, while governmentintervention was the key in the Nether-lands. Inequalities within countries vary aswell; rural/urban divisions, regional socio-economic status and decentralised gover-nance seemed to be the most important

factors, although economic resourcesshould not be discounted.

The needs of patients with terminal ill-nesses, however, are strikingly similar: highquality multi-disciplinary care with clearpathways and lines of communication be-tween the care team, the patients, theirloved ones and other related professionals;treatment options which allow them to stayin their homes as much as possible, reduc-ing suffering and respecting their wishes;and a social network which actively in-cludes patients and their families in a supportive community.

Europe could play an important role insome of these key areas: currently, thereare neither accepted standards nor evi-dence-based solutions to measure the qual-ity of a programme. Official certificationfor professionals is not available in mostcountries. It would be ideal if palliative carewere recognised on the same terms as othersocial and health care structures, therebyensuring funding and investments in organisation. European support for theseobjectives would be welcome, both by pa-tients and professionals in the young pal-liative care field. Furthermore, it is our hopethat by directly engaging high-level stake-holders in the formulation of the report,we have opened a new door to the self-examination of palliative care serviceswithin the different national health systems.

Policy optionsWith this in mind, and knowing that theEuropean Parliament was not looking fora prescriptive solution, but for a range ofoperational alternatives, we presented threepolicy options based on solid data and experience collected and documented dur-ing our investigation. The first was a con-servative, horizontal approach, which intheory could be accomplished by simplyacknowledging palliative care as a medicalfield. A second strategy was a recommen-dation to Member States on further actionsto take; this has been an effective tool in thepast to promote development in targetedareas while respecting national sovereignty.A third course of action was to intervenedirectly with European legislation. Thesetactics were detailed fully in the report andare summarised in Table 1.

DiscussionThe proposals were presented to the Euro-pean Parliament; however, many of theideas are relevant for national policy-mak-ers as well. We believe that the report itselfconstitutes a potentially effective tool for


PALLIATIVE CARE

Box 1. Areas of assessment

• Availability and access, including place ofcare, paediatric palliative care and availability of opioids

• Integrated health care networks

• Human resources, including GPs, nurses,palliative care and paediatric palliativecare specialists, psychologists, socialworkers and volunteers

• Quality assurance

• Emotional and psychological support

• Legal and policy provisions

• Financial planning models

• Best practices

lobbying efforts, and we continue to sup-port its dissemination. In May 2008, the re-sults were presented at the 11th Congress ofthe European Association for PalliativeCare in Vienna, where the team leader reit-erated his encouragement for its use in thenational and European context. For gov-ernments with limited experience in pallia-tive care policy, section two of the report,detailing the basic elements of a successfulprogramme, is a useful summary and buildsthe foundations of knowledge to begin de-bating on what policies would work best intheir country context. Section three pro-vides a concise quantitative and qualitativecomparison on service provision in Mem-ber States. It provides an idea of what ispossible within limited resources. Sectionfour, covering best practices, has a bench-marking function and aims to both recog-nise merit and stimulate interest in success-ful initiatives. Finally, the conclusions andpolicy options set out a flexible and adapt-able plan of action to move forward.

Unlike other issues which have receivedmore rapid attention from the EuropeanParliament following the publication of anindependent report, palliative care has yetto be added to the agenda. Particularlynow, as the world financial economyteeters and the EU and Member Statesstruggle to find a coherent response, it willbe challenging to return palliative care pol-icy to the European and national stages.However, the ageing of the populationmeans that this issue will gain relevancerather than lose it in the coming years. Lo-cal activism has been the principal engine ofpalliative care development in most Euro-pean countries since its beginnings in thelate 1960s in England, and it must continueto be so for the sake of patients and theirloved ones. Real development in Europewill not be the fruit of this report, butrather the result of how it is utilised, incombination with other advocacy tools, toraise awareness, disseminate knowledge,and fight for lasting change.

REFERENCES

1. Martin-Moreno J, Harris M, Gorgojo Let al. Palliative Care in the EuropeanUnion. Brussels: European ParliamentEconomic and Scientific Policy Depart-ment, 2008. IP/A/ENVI/ST/2007-22. PE404.899 [Online] Available at:http://www.europarl.europa.eu/activities/committees/studies/download.do?file=21421

2. Centeno C, Clark D, Lynch T et al.EAPC Atlas of Palliative Care in Europe.Milan: IAHPC Press, 2007.

3. Gronemeyer R, Fink M, Globisch M,Schumann F. Helping People at the End ofTheir Lives: Hospice and Palliative Care inEurope. Berlin: Lit Verlag, 2005.

4. Clark D, Wright M. Transitions in Endof Life Care: Hospice and Related Developments in Eastern Europe and Central Asia. Buckingham: Open University Press, 2003.


PALLIATIVE CARE

Table 1. Policy options to advance palliative care in the European Union

Strategy Course of action Advantages Disadvantages

Conservative andhorizontalapproach

• Ensure that palliative care is recognised as a medical field

• Bolster general measures to improve health care delivery,such as reducing waiting times and declaring a Patient�s Bill of Rights

Minimise bureaucracy andincrease flexibility in innovationand treatment decisions

Given the lack of development inmany countries, this approachmay not be enough to guaranteequality or access.

Recommendationsto Member States

Some possible recommendations:

• Formulate national plan on palliative care

• Increase investments in training and research

• Improve accessibility and proper use of opioids

• Promote integrated health care networks

• Facilitate specialist accreditation

• Identify and promulgate best practices

• Forge partnerships within and between countries

This could be an excellent toolfor advocacy in many MemberStates while respecting somecountries� wishes for no newlegislation.

It could also pave the way forrecognised guidelines in Europe.

Because it is important to ensuresome degree of harmonisationin such an important field, thisplan may fall short.

New Europeanlegislation or directives

Possible areas of legislation:

• Guarantee equal rights for all patients

• Ensure availability of opioids

• EU action plan and monitoring system

• Declare palliative care to be a human right

• Create a dialogue with Member States to discuss prioritiesand identify challenges

• Establish a European platform to stimulate research

• Establish an interface between research and policy

• Create a European Reference Centre or European Institute of Palliative Care

• Promote cross-border cooperation and patient mobility

Direct European Parliamentaryinvolvement would work to makepalliative care a priority on theEuropean agenda and wouldbring about an enormousadvance where palliative care iscurrently not very developed.

Investments, especially inresearch and training, wouldprovide welcome stimulus to the field.

Harmonisation efforts could beproblematic for countries whosepalliative care programmes arealready developed.

Additionally, European compe-tence in national health systemshas yet to be solidly established,which would make some of theproposals very difficult toachieve.

http://www.europarl.europa.eu/activities/committees/studies/download.do?file=21421


PERSPECTIVES FROM THE US

The increasing burden of disease, particu-larly chronic diseases, along with more so-phisticated medical treatment has dramat-ically increased the complexity of healthcare delivery. Fragmented systems of caredelivery, teams and layers of clinicians andcomplex treatment protocols require ad-ministrative oversight and integration thathealth information technology (HIT) canprovide.

While many high-income countries likeDenmark, England, Norway and Swedenhave made great strides in implementingHIT systems, health care administrationin the United States remains predominatelypaper-based. If the utility gained from increased health technology is to benefit individuals and society, barriers to imple-mentation of HIT and health informationexchange must be overcome in ways thatallow health care organisations to moveforward with quality improvement agendasthat use HIT as a tool for work practice improvement.

A federal-state framework for HIT imple-mentation that addresses the commonlycited barriers of engagement, privacy, se-curity, and fiscal sustainability is widelyseen as essential for HIT diffusion in theUS. In recent years, significant attempts toadvance the HIT agenda have occurred atboth state and federal level. This articlehighlights some of the current efforts to develop this framework and discusses thelikely next steps.

Federal organisation of HITThe recent passage of the American Recovery and Reinvestment Act of 2009provides $19 billion in federal spending tomove the HIT implementation agenda for-ward. While the United States has a rela-tively decentralised governance system,with policies usually formulated at thestate-level, a national framework is neces-sary in order to preserve privacy and secu-rity and to ensure interoperability betweenlocal and regional systems.

As a step toward a national framework,the American Health Information Com-munity (AHIC) was formed in 2005 withthe goal of providing recommendations tothe Secretary of the Department of Healthand Human Services (HHS) on how to ac-celerate HIT.1 AHIC came up with a list ofpriorities and standards gaps for a nationalIT strategy. However, this federal body

work group failed to engage the privatesector (manufacturers of health technol-ogy software) and consumers of HIT suchas physician practices. Subsequently,AHIC was reinvented as a public privatepartnership, being succeeded by AHICSuccessor and eventually in 2008, the National eHealth Collaborative (NeHC).With funding of $13 million over a two-year period, NeHC coordinates with theCertification Commission for HealthcareInformation Technology (CCHIT), whichis formally recognised as the HIT accred-iting body by HHS and the Health Infor-mation Technology Standards Panel(HITSP), which is made up of voluntarystandards experts to develop interoper-ability standards.2

Without mandated interoperability stan-dards, physicians and other providers maybe hesitant to buy HIT software for fearthat they might need to replace it in thenear future to meet developing standards.Thus, the purpose of CCHIT is to certifyhealth IT products, including electronichealth records, so that providers can beaware that ‘CCHIT Certified’ productsmeet basic requirements for functionality,interoperability, security and privacy. Sofar, CCHIT has certified 160 health infor-mation programmes.3 However, it is possible that CCHIT’s fee for vendor ac-creditation is too high and deters smaller

Health information technologyin the United States: Can planning lead to reality?

Natasha Desai, Brendan Krause and Marin Gemmill-Toyama

Summary: The United States has started to implement electronic health technologies due to the increasingly complex nature of health care. This paperaims to review the organisation of health information technology in the USthrough the analysis of standards and privacy protocols at the federal leveland programme implementation at the regional level. Recommendations forpolicy planning are given in the conclusion, as well as insight into the need tomerge the health information technology agenda with quality improvementgoals so as to align incentives for providers, patients and payers.

Keywords: health information technology, quality, health systems, USA

Natasha Desai is Research Assistant,Brendan Krause Fulbright Scholar andMarin-Gemmill-Toyama ResearchOfficer, LSE Health, London School ofEconomics and Political Science.Email:[email protected]


companies from obtaining certification.Regardless, the fact that CCHIT productsguarantee a certain level of interoperabilityshould decrease barriers to implementa-tion of electronic health records.

In terms of privacy and security, the exist-ing privacy laws in the US have not beenamended to include provisions for elec-tronic transmission and storage of medicaldata. The US Privacy and Security Solu-tions for Interoperable Health Informa-tion Exchange project, which was launchedin 2005 by the Agency for Healthcare Research and Quality (AHRQ) and theNational Coordinator for Health Infor-mation Technology, aimed to determinethe necessary level of protection for healthinformation. The project concluded thatthere was a patchwork of practices, policiesand state laws that protected health dataand several conflicting laws regarding security existed.

The primary federal law covering privacyand security is the Health Insurance Porta-bility and Accountability Act (HIPAA) of1996. Importantly, Regional Health Infor-mation Organisations (RHIOs) haveemerged as local initiatives to facilitatehealth information exchanges (HIEs) butHIPAA laws do not extend to RHIOs,prompting concern about data security atthe local level.

The implementation of HIPAA laws alsovaries considerably from state to state be-cause there is a provision that permits stateswith more protective laws to continue withtheir existing laws.4 For example, somestates require consent for nondisclosure inall situations while other states only re-quire consent in some situations, creatingvariability that could result in difficulties incross border care, especially in emergen-cies.4 While some feel that more stringentfederal privacy rules are key in the nationalIT strategy, others strongly feel that addingmore stipulations would only provide barriers to health information exchange,slowing implementation.5

Why would there be a state role in HIT?Inter-state integration is a key HIT chal-lenge for US policymakers, not just interms of HIE, but for health system designand reform generally. It is important tonote that these state barriers are not just le-gal, but are historic and cultural, partiallybecause it was the states that originallyworked together to create the federal gov-ernance structure. This history plays out inmodern policy making by leaving stateswith substantial responsibilities for regu-

lating the health care marketplace.

Rather than viewing individual state regu-lation and policy as a barrier, there is astrong case to be made for a major staterole in the development of the US HIT in-frastructure. States regulate and licenseproviders, clinics, hospitals and healthplans. States protect important consumerrights, including privacy. States purchasehealth care for large numbers of public em-ployees and they also finance and managehealth care services through programs suchas Medicaid and the State Children’sHealth Insurance Programme. These roleshave given states strong competencies indelivery system management and design.However, for a national HIT infrastruc-ture that enables the electronic exchange ofimportant clinical and epidemiological datato succeed, state policies will have to bealigned.

What have states done so far?Recognising the important role for statesand the significant planning tasks beforeboth state and federal policymakers, severalfederal-state partnerships have emerged.Ranging from grants and technical assis-tance for individual projects to consensusbuilding bodies comprised of stakehold-ers from government, as well as the privatesector, these partnerships offer a potentialway forward from policy to practice.

AHRQ state and regional demonstrationgrants

In 2004 and 2005, the AHRQ gave demon-stration grants to six states: Colorado,Delaware, Indiana, Rhode Island, Ten-nessee and Utah. These ‘State and RegionalDemonstrations of Health InformationExchange’ provided five years of fundingfor projects that demonstrated state or re-gional interoperability and data sharing forquality improvement. Grantee states areusing different governance and businessmodels that will enable exchange of clinicaldata and that can demonstrate a sustain-ability model. Grantee states must also determine the role that the Medicaid pro-gramme (for state residents who are pooror living with disabilities) will play in theHIE model. AHRQ shares the states’ find-ings through a technical assistance centrecalled the National Resource Centre forHealth IT .6

Health Information Privacy and SecurityCollaboration

Concerned that state-level privacy and security laws for individual patient datacould in themselves provide a barrier to

HIE, yet must continue to protect con-sumer interests, the Office of the NationalCoordinator for Health Information Tech-nology and AHRQ created the Health Information Security and Privacy Collab-oration (HISPC). HISPC offered compet-itive federal funding to forty states and thetwo territories of Guam and Puerto Ricothat established multi-stakeholder com-missions to analyse state privacy and secu-rity laws and business practices that couldinterfere with HIE.

In particular, HISPC teams looked for statepolicies that went beyond the privacy stan-dard established by the federal HIPAA.The eighteen month contracts were man-aged by RTI International, a non-profitmanagement consultancy, working in part-nership with the National Governors Association Centre for Best Practices, thenon-profit technical assistance arm of theState Governors’ Membership Associa-tion.7

State Alliance for e-Health

In January 2007, the Office of the NationalCoordinator awarded a contract to the Na-tional Governors Association Centre forBest Practices to create a consensus-build-ing entity known as the State Alliance fore-Health (State Alliance). The purpose ofthe State Alliance is to provide a nationalplatform on which to discuss and analysestate health policies that could lead to HIE.Co-chaired by two governors, the StateAlliance is comprised of state legislators,attorneys general, insurance commission-ers, local government administrators andprivate sector representatives.8 The Alliance, also composed of task forces, is-sues recommendations for HIT adoptionand implementation.

Where to go next?

After years of investment in state planningand collaboration, it is reasonable to askwhat precisely has been learned and howthese findings can be taken forward. Whilenot yet a concrete plan of action, recom-mendations contained in the 2008 reportfrom the Public Programmes Implementa-tion Task Force of the State Alliance for e-Health provides some insight into theconsensus growing among policymakers.The taskforce recommendations focusedon five main points:

– Setting state e-Health goals;

– Educating providers and consumers;

– Encouraging group and collaborativepurchasing of HIT services;



– Providing incentives for adoption; and

– Requiring adoption and use of HIT.

Specific recommendations include creat-ing a state-level coordinating body for HITwith authority for individual state agen-cies; creating provider mentoring and con-tinuing education programmes to helppractices to change patterns; negotiatinggroup discounts to lower HIT start-upcosts; and altering reimbursement schemesto incentivise phased-in HIT adoption. Ingeneral, the specific recommendations foreach category present a roadmap in whichvoluntary standards and incentive struc-tures lead to uniform, and at times manda-tory, standards for HIT and HIE. Deter-mining precisely which responsibilities andstandards should be left with state policy-makers, as well as those which must liewith the federal government, will prove anessential component of the US frameworkfor HIT.9

ConclusionThe complexity of health care delivery inthe US presents not only the strongest casefor HIT deployment but also the biggestchallenge to achieving true health infor-mation exchange. Federal, state and localinitiatives demonstrate that there is muchenthusiasm for the promise of HIT, butthe existing patchwork of laws and prac-tices highlights the need for more centralguidance and coordination, particularly inclarifying privacy and security issues andensuring interoperability. The $19 billionstimulus bill may be an important factor inachieving these goals, particularly throughthe funding that it provides via Medicarepayments for physicians to adopt HIT.While the legislation provides yearly in-centive payments to physicians, including$15,000 for the first year of implementationand $12,000 for the second year; a studydone by Miller et al. in 2005 found that forsmall group practices the cost for HIT im-plementation would be upwards of $44,000per provider in upfront costs, not includingrevenue lost due to training or loss of productivity.10

While impressive in their commitment andforward in their thinking, to date most USplanning efforts for HIT implementationhave focused on the technological inter-ventions or the standards that define theirmakeup rather than the problem that thetechnologies are intended to solve. This isa path that many other nations have fol-lowed with varying degrees of success.While such planning is certainly necessary,it may not be sufficient to spur the desired

level of diffusion of HIT or to gain the po-tential benefits from its use.

Directly merging the HIT agenda with spe-cific quality improvement goals could rep-resent the ideal next generation of HITplanning. Linkage of HIT adoption initia-tives with initiatives that target chronic carecould be the first step in applying a moredynamic approach. Targeting the highest-cost and most prevalent diseases with theaim of improving care coordination andadherence to a clinical standard could pro-vide the structure of a national system thatis lacking, while leaving room for innova-tion and regulation.

While the US health care system is frag-mented, defining priority areas and adopt-ing consensus treatment protocols for pa-tients over the course of an episode of carewould create clear lines for intervention, byproviders, by payers, and patients alike.These links might then be reinforcedthrough Information CommunicationTechnology (ICT) which would facilitatethe coordination of that care. The ICTwould also make it easier for the providerto care for the patient according to the pro-tocols that are agreed upon to improvequality for a specific condition, rather thanaccording to new workflow processes de-termined by the software package. More-over, state and federal government couldcontinue to work together to lead and convene the stakeholders they have suc-cessfully gathered. In short, fixing a prob-lem that everyone acknowledges with a solution that provides value to all stake-holders seems the best way forward, notonly in the HIT world, but in the realworld as well.

REFERENCES

1. HealthIT.hhs.gov. American Health Information Community (AHIC). Washington D.C: Department of Healthand Human Services, 2009. Available athttp://tinyurl.com/qom33q

2. Halamka J, Leavitt M, Tooker J. Ashared roadmap and vision for health IT.EHR Decisions, 2009. Available athttp://ehrdecisions.com/papers/a-shared-roadmap-and-vision-for-health-it/

3. Certification Commission for Healthcare Information Technology.Choosing CCHIT Certified Products.Chicago: CCHIT, 2009. Available athttp://www.cchit.org/choose/index.asp

4. Dimitropoulos L, Rizk S. A state-basedapproach to privacy and security for interoperable Health Information

Exchange. Health Affairs2009;28(2):428–34.

5. McDonald C. Protecting patients inhealth information exchange: A defence ofthe HIPAA Privacy Rule. Health Affairs2009;28(2):447–49

6. Agency for Healthcare Quality and Research. Fact Sheet: Health InformationTechnology: State and Regional Demon-stration Projects. Rockville: AHQR, 2007.Available at http://www.ahrq.gov/research/hitdemoproj.pdf

7. RTI International. The Health Information Security and Privacy Collaboration (HIPSC) expanded to focuson multi-state privacy and security solutions for electronic health informationexchange. Research Triangle Park: RTI International, 2008. Available athttp://tinyurl.com/puhqgm

8. National Governors Association. NGA Centre announces State Alliance for e-Health. Washington, DC: National Governors Association, 2006. Available athttp://tinyurl.com/o7ldw7

9. University of Massachusetts MedicalSchool Center for Health Policy and Research. Report from the Public Programmes Implementation Taskforce tothe State Alliance for e-Health. Washington, DC: National Governors Association, 2008. Available athttp://www.nga.org/Files/pdf/0812EHEALTHPPIREPORT.PDF

10. Miller RH, West C, Martin Brown T,Sim I, Ganchoff C. The value of electronichealth records in solo or small group practices. Health Affairs2005;24(5):1127–37.



http://tinyurl.com/qom33q

http://ehrdecisions.com/papers/a-shared-roadmap-and-vision-for-health-it/

http://www.cchit.org/choose/index.asp

http://www.ahrq.gov/research/hitdemoproj.pdf

http://tinyurl.com/puhqgm

http://tinyurl.com/o7ldw7

http://www.nga.org/Files/pdf/0812EHEALTHPPIREPORT.PDF

Picture this: two fifty year-old men areexperiencing chest pain and abnormalheart rhythms. One of the men is admit-ted for care at a local community hospitalin a small town. The other is admitted ata teaching hospital in one of the nation’slargest cities. It’s natural to assume thatthe city-dweller will fare better, since hishospital spends more money and there-fore has greater resources and providesmore specialised care. In the same way,it’s instinctive to think that the small-town patient will suffer worse outcomes,since his hospital has less money withfewer resources and poorer access to specialised care.

According to the research, however,when it comes to invasive procedures,and even diagnostic testing, “less is more. . . and better”.1 In fact, compared to pa-tients in regions that spend less, patientsin high-spending regions are no more sat-isfied with their care, and actually experi-ence a greater risk of harm and possiblyeven death.2–4

Where you live begets the care youreceiveIn many cases, it’s difficult to determinewhether patients receive appropriate care.What is known is that there is great varia-tion in the amount of health care peoplereceive that depends largely on wherethey live.5–12 For more than fifteen yearsthe Dartmouth Atlas Project, led by JohnE Wennberg and Elliott S Fisher, hastracked “glaring variations” in the distri-bution and use of health care resources inthe United States.2 Based on US Medicaredata, the studies consistently show thatmore resources – specifically, frequent

specialist visits, diagnostics, and specialistand hospital care – don’t necessarily leadto better care (see Table).

In one study involving nearly one millionpatients dispersed over 306 regions in theUS (based on where people go for hospi-tal care), Fisher and colleagues found thatpatients in high-spending regions received 60% more care than those in the

lower-spending areas. However, they didnot experience lower mortality rates, better functional status or higher satisfac-tion.4 In fact, patients in the lower-spend-ing regions actually received certain pre-ventive services (influenza vaccination,Pap smear and mammography) more of-ten than patients in the highest-spendingareas.3

It’s not just an American phenomenon.In Ontario, the Institute for ClinicalEvaluative Sciences has documented largeregional variations in the provision ofhealth care for a range of services. Specifically, patients with conditions suchas cardiac disease,8 stroke,9 arthritis,10

asthma,11 and diabetes12 are getting vary-

Mythbusters


Myth: In health care, more is always better

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

The full series is available at www.chsrf.ca/mythbusters/index_e.phpThis paper was first published in July 2008. © CHSRF, 2008.

Table: Select Dartmouth Atlas studies comparing regional differences in spending and the content,quality and outcomes of care13

High-spending regions compared to low-spending regions*

Content and quality of care3,5,14 Less adherence to process-based measures of quality

Little difference in rates of major elective surgery

More hospital stays, physician visits, specialist referrals,imaging, and minor tests and procedures

Health outcomes4,15,16 Higher mortality over a five-year period following heartattack, hip fracture and colorectal cancer diagnosis

Higher survival in regions that practiced medical versusinvasive cardiac management of heart attack patients

No difference in functional status

Physician perceptions of quality17 More likely to report poor communication among physicians

More likely to report inadequate continuity of care

Greater difficulty obtaining inpatient admissions or high-quality specialist referrals

Patient reported quality of care18 Worse access to care and greater wait times

No difference in satisfaction

* High and low spending regions are defined as the US hospital referral regions in the highest andlowest quintiles of per capita Medicare spending.3

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


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

ing degrees of care, despite the availabil-ity of evidence-based clinical guidelinesin these areas.

Canadian research also highlights that insome cases, ready access to care can be abad thing for patients. A Vancouver-based study that assessed the effectivenessof a range of elective surgeries found thatcataract surgery was often ordered in theabsence of significant visual impairmentand that it left 27% of patients reportingno change or even deterioration in theirvisual function.19 A built hospital bed is afilled one

Other predictors can also drive the useand, more specifically, the overuse ofservices. These include patient demand, amedical culture in which physicians oftendo more tests and interventions than arereally necessary, and the fee-for-servicestructures that reward physicians for pro-viding more and more care.20 One partic-ularly strong predictor that factors intothe equation is the availability of healthcare resources such as hospital beds andspecialists.5 As the 1960s health servicesresearcher, Milton Roemer put it, “Abuilt hospital bed is a filled hospitalbed.”5 In practice, ‘Roemer’s Law’ canindicate inefficient systems that offer ineffective and inappropriate care for patients.

ConclusionAlthough Canadians may feel betterwhen they live in close proximity andhave quick access to health care re-sources, the research suggests they maybe experiencing a false sense of security.So is there such a thing as too much med-icine? Almost certainly there is, accord-ing to a 2002 issue of the British MedicalJournal.21 And as everyday life becomesincreasingly medicalised, with a new pillor procedure constantly in development,the problem is growing.21 At the sametime, some patients benefit from invasive,high-tech care, but better evaluation ofhealth care performance is needed toidentify these cases. Doing so would helpin matching resources to populationneed, with a view to clinical and financialefficiency and overall improvements inquality of care.

REFERENCES

1. Berwick DM. Invasive Procedures: LessIs More … and Better. Newsweek 2006,October 16. Available athttp://www.msnbc.msn.com/id/15176095/site/newsweek/print/1/displaymode/1098/

2. The Dartmouth Atlas Project. Availableat http://www.dartmouthatlas.org/

3. Fisher ES et al. The implications of regional variations in Medicare spending.Part 1: The content, quality, and accessibil-ity of care. Annals of Internal Medicine2003;138(4):273–87.

4. Fisher ES et al. The implications of regional variations in Medicare spending.Part 2: Health outcomes and satisfactionwith care. Annals of Internal Medicine2003;138(4):288–98.

5. Wennberg JE, Fisher ES, Skinner JS. Geography and the debate over Medicarereform. Health Affairs 2002; (Suppl. Webexclusive):96–114.

6. Gentleman JF, Vayda E, Parsons GF,Walsh MN. Surgical rates in sub-provincialareas across Canada: Rankings of 39 procedures in order of variation. CanadianJournal of Surgery 1996;39(5):361–67.

7. Roos NP, Roos LL. Surgical rate varia-tions: Do they reflect the health or socio-economic characteristics of the population?Medical Care 1982;20(9):945–58.

8. Tu J, Ghali W, Pilote L (eds). CCORTCanadian Cardiovascular Atlas. Toronto:Pulsus Group Inc and Institute for ClinicalEvaluative Sciences, 2006. Available athttp://www.ccort.ca/CanadianCariovascularAtlas/tabid/77/Default.aspx

9. Kapral MK et al. Registry of the Cana-dian stroke network: Report on the 2002/03Ontario Stroke Audit. Toronto: Institutefor Clinical Evaluative Sciences, 2003.Available at http://www.ices.on.ca/webpage.cfm?site_id=1&org_id=68&morg_id=0&gsec_id=0&item_id=4021&type=report

10. Badley EM, Glazier RH (eds). Arthritisand Related Conditions in Ontario: ICESResearch Atlas. Toronto: Institute for Clinical Evaluative Sciences, 2004.

11. To T et al. Burden of ChildhoodAsthma: ICES Investigative Report.Toronto: Institute for Clinical EvaluativeSciences, 2004. Available atwww.ices.on.ca/file/ACF77.pdf

12. Hux JE, Booth G, Slaughter P, LaupacisA (eds). Diabetes in Ontario: An ICESPractice Atlas. Toronto: Institute for Clinical Evaluative Sciences, 2003. Avail-able at http://www.ices.on.ca/webpage.cfm?site_id=1&org_id=31&morg_id=0&gsec_id=0&item_id=1312

13. Wennberg JE, Fisher ES, GoodmanDC, Skinner JS. Tracking the Care of Patients with Severe Chronic Illness: TheDartmouth Atlas of Health Care 2008.Lebanon, New Hampshire: Dartmouth Institute for Health Policy and ClinicalPractice, 2008. Available athttp://www.dartmouthatlas.org/atlases/2008_Chronic_Care_Atlas.pdf

14. Baicker K, Chandra A. Medicarespending, the physician workforce, andbeneficiaries’ quality of care. Health Affairs 2004;(Suppl. Web exclusive):184–97.

15. Stukel TA, Lucas FE, Wennberg DE.Long-term outcomes of regional variationsin intensity of invasive vs medical manage-ment of patients with acute myocardial infarction. Journal of the American MedicalAssociation 2005;293(11):1329–37.

16. Skinner JS, Staiger DO, Fisher ES. Istechnological change in medicine alwaysworth it? The case of acute myocardial infarction. Health Affairs 2006; (Suppl.web exclusive):34–37.

17. Sirovich BE. Regional variations inhealth care intensity and physician perceptions of quality of care. Annals ofInternal Medicine 2006;144(9):641–49.

18. Fisher ES, Wennberg DE, Stukel TA,Gottlieb DJ. Variations in the longitudinalefficiency of academic medical centers.Health Affairs 2004; (Suppl. Web exclusive):19–32.

19. Wright CJ, Chambers GK, Robens-Paradise Y. Evaluation of indications for and outcomes of electivesurgery. Canadian Medical AssociationJournal 2002;167(5):461–66.

20. Juahar S. Many doctors, many tests, norhyme or reason. New York Times 2008,March 11. Available at http://www.nytimes.com/2008/03/11/health/views/11essa.html

21. Moynihan R, Smith R. Too much medicine? British Medical Journal2002;324:859–911.

http://www.msnbc.msn.com/id/15176095/site/newsweek/print/1/displaymode/1098/

http://www.dartmouthatlas.org/

http://www.ccort.ca/CanadianCariovascularAtlas/tabid/77/Default.aspx

http://www.ices.on.ca/webpage.cfm?site_id=1&org_id=68&morg_id=0&gsec_id=0&item_id=4021&type=report

http://www.ices.on.ca/file/ACF77.pdf

http://www.ices.on.ca/webpage.cfm?site_id=1&org_id=31&morg_id=0&gsec_id=0&item_id=1312

http://www.dartmouthatlas.org/atlases/2008_Chronic_Care_Atlas.pdf

http://www.nytimes.com/2008/03/11/health/views/11essa.html

Let’s be honest. There are times when the eyesglaze over and the brain goes into a dreamliketrance when statistics and probabilities are thrownaround, especially when devoid of any apparentlink to reality. Statistics does that to most people,apart, that is, from some statisticians and a smallnumber of pointy-headed academics.

The rest of us feel a need to be grounded, to havesome grasp, however tenuous, of what the num-bers mean, and how they affect us or other people.It's why we get upset with media headlines abouta doubled risk of some incredibly rare event.

Even so, there are times when something comesalong that makes us stop and think, and to strug-gle with the arcane world of statistics and meta-analysis. A recent meta-analysis on antidepres-sants published in The Lancet1 is one such,perhaps because it might be something of a watershed, not because of the statistics, but thethinking behind it.

What is efficacy?Let's start with something comparatively easy.What does efficacy mean? Now there are lots ofdifferent definitions, but let's keep this simple. Tomost of us simple people, there are three questionswe want answered, and we don't really care whatthey are called. Bandolier thinks these three ques-tions worth asking about the ‘efficacy’ of any intervention are:

Does it work? In most, but not all, cases, this implies doing better with the intervention thanwith an inactive intervention like placebo. Statis-tics can be useful here, things like relative risk, andp values.

How well does it work? After all, it's not muchgood if something works a very, very, little bit.Ideally we want the intervention to work reallywell. Here we might want an NNT (numberneeded to treat).

How well does it work compared with other interventions we have for this condition?Here we

might compare NNTs for efficacy outcomes (inleague tables on some occasions), but realise quitequickly that there are other issues to consider,like adverse events, and whether patients will ac-cept it, and the cost, and so on. At various timesratios of NNT to NNH (number needed to harm)has been suggested, but in truth there hasn'tseemed to be any approach with general applica-bility. Here we begin to move from efficacy (doesit work) to effectiveness (how well does it work inpractice).

That is where the multiple-treatment meta-analy-sis comes in, and can be helpful. Bandolier thinksthere is a way of making the approach easier, anddo-able on the back of an envelope, but first, abrief description on what was going on.

BackgroundDrug treatment of depression involves frequentswitching to find a drug that works well for thatparticular patient, because of the usual problemsof lack of efficacy or adverse events. Bandoliercovered a terrific randomized controlled trial(RCT) that looked at just this issue (Bandolier95-4), in which only 44% of patients started on adrug were on it at the end. The trial showed thathaving three SSRIs (selective serotonin reuptakeinhibitors) was much better than one. An accom-panying editorial made the point that while thethree SSRIs were equal on average in clinical trials, they were not equal for every individualpatient.

Inevitably, we need more than one antidepres-sant. The question isn't whether they work orhow well they work, but which of them worksbest, and how might we choose to use them in asequential treatment cascade to get the best resultsfor patients, both individually, and for the wholepopulation with depression. The multiple treat-ments meta-analysis set out to ask whether any oftwelve new generation antidepressants were no-ticeably better than the others.

MethodsThe data set was 117 randomised trials comparingone antidepressant with another; placebo-onlycontrols were not used. Trials lasted six to twelveweeks. Doses of drugs were set as low, medium, or


Assessing relative efficacy of antidepressants

Evidence-based health care

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

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

“The questionisn't whether theywork or how wellthey work, butwhich of themworks best, andhow might wechoose to usethem”

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


EVIDENCE-INFORMED DECISION MAKING

high, depending on pre-set criteria.

Two outcomes were used. The first, and ef-ficacy outcome, was at least 50% reductionin a recognised depression score, or clinicalglobal impression of much or very muchimproved, at eight weeks. The second, ac-ceptability, outcome was all-cause with-

drawals at eight weeks. Some sophisticatedstatistics were then done, both on pairwiseanalyses and then on all the data comparingdirect and indirect comparisons, and didsensitivity analyses on doses within thetherapeutic range, and on methodologicalissues.

ResultsResults were expressed as the probabilityof any of the twelve drugs being among thetop four for both efficacy and acceptability.Figure 1 shows the cumulative probabilityfor both criteria as a percentage – withhigher percentages obviously better.

Some drugs (sertraline, escitalopram) dowell on both counts, while others (citalo-pram, mirtazapine, venlafaxine) do well inone but not the other. Some (paroxetine,reboxetine) have a low probability of beingin the top four on either criterion. Issues ofdose and method made no difference tothe overall results in sensitivity analyses,and direct and indirect analyses gave different results no more than may be expected by chance.

CommentThis is excellent. Knowing that several an-tidepressants perform generally better thanothers is useful, and we may conclude thatthose at the top of the ladder might comeearlier in any care pathway of treatmentstrategy, but that doesn't mean that theothers are without effect.

Bandolier has tried a slightly different ap-proach using the data from the paper. Fig-ure 2 shows the numbers of patients with

0 5 10 15 20 25 30

Acceptability

Efficacy

Milnacipran

Bupropion

Reboxetine

Duloxetine

Fluoxetine

Fluvoxamine

Venlafaxine

Paroxetine

Mirtazapine

Citalopram

Escitalopram

Sertraline

Cumulative probability (%) of being among top four

Figure 1: Probability of being among top four drugs for efficacy (at least 50% reduction indepression score) and acceptability (all cause withdrawal) at mean of eight weeks of treatment

Figure 2: Simplified assessment of efficacy and acceptability using simple percentages for efficacy (at least 50% reduction in depression score) andacceptability (all cause withdrawal) at mean of eight weeks of treatment, together with some information on cost

CIPRIANA DECONSTRUCTED

Substantial improvement ≥50% reduction from baseline(higher percentage better)

All cause withdrawal(lower percentage better)

Events Total % Events Total %

Consider using oneof these drugs first

Sertraline 1528 2453 62 515 2317 22

Escitalopram 1617 2736 59 542 2859 19

Citalopram 1096 1928 57 384 2088 18

Mirtazapine 862 1398 62 312 1251 25

Probably useful when first four shown not to behelpful

Paroxetine 1936 3427 56 973 3621 27

Venlafaxine 1696 2827 60 727 2855 25

Fluvoxamine 407 779 52 195 779 25

Fluoxetine 2857 5196 55 1427 5145 28

Probably not worthconsidering at all

*not licensed fordepression in the UK

Duloxetine 690 1368 50 326 1217 27

Reboxetine 326 683 48 211 683 31

* Bupropion 928 1623 57 474 1708 28

* Milnacipran 271 569 48 197 569 35

Costs key:

(shade of bax behind drug name)

<£5 per month Efficacy and acceptability key: Indicates most effective or acceptable

£5–10 per month Indicates intermediate efficacy or acceptability

£15–25 per month Indicates least effective or acceptable

>£25 per month

efficacy and acceptability criteria, the totalnumber, and the percentage with each out-come. These were then simply divided intothose with the best (white background)and worse (shaded light grey) performancefor each outcome, with the others shadedmid grey. There is broad agreement withthe statistical approach. Drugs doing bestwith efficacy generally also did well for ac-ceptability, while those doing worse for ef-ficacy generally did worse on acceptability.

In addition, simple cost information is pro-vided, based on approximate cost for amonth of treatment in the UK, usingBritish National Formulary costs formedium doses. Generally, those drugs do-ing better on efficacy and acceptability hadlower costs.

The implication is again that in creatingcare pathways it would be better to use thedrugs at the top of the table first. Note thattwo of the twelve drugs (bupropion, mil-nacipran) do not have a UK license for depression at the time of writing.

Objections Not everyone likes the meta-analysis, andMeReC2 took issue with it on a number ofpoints. It is useful to question them.

(1) Most studies were done by pharmaceu-tical companies. That of course is true, andlarge independent trials are perhaps to bedesired. But the fact is that, in the world inwhich we live, most trials have commercialinterests. The development of rigorous criteria for design, reporting, conduct, andmonitoring of trials has been instituted toprevent commercial and other biases affecting results. Ask the question fromanother angle: where is the convincing ev-idence that these trials are wrong? Theyhave been accepted by regulatory agencieslike the FDA (US Food and Drug Admin-istration) and EMEA as being adequate,on the basis of much greater detail than ispresented in published papers.

(2) Discrepancies existed between indirectand direct comparisons. This is directly an-swered in the paper, where six out of 133comparisons were different, exactly the ex-pected number by chance alone. Put theother way, 127 out of 133 direct and indi-rect comparisons gave the same result.

(3) Studies were poor quality. The descrip-tion of treatment allocation was unclear inmost trials (105/117 trials), as it is in 90%of trials. There are two Cochrane reviewsjust published on escitalopram and sertra-line.3,4 These show that all trials were de-scribed as both randomised and double

blind, the areas most likely associated withbias. As the meta-analysis itself discusses,this is usually an issue of reporting in jour-nals with tight word limits rather than anissue of conduct. The problem with usingtreatment allocation concealment as themain or only criterion means that unclearis the best you can get.

(4) Mean sample size was small. The meansample size was 110 participants per group(range 9–357). Bandolier is also concernedabout small studies, and prefers omittingtrials of small size. But one of the reasonswe do meta-analyses is to overcome theproblem of size. A quick look at Figure 2shows that for most of the drugs there wereimpressively large numbers, and in totalabout 26,000 patients were involved. Noneof the drugs favoured had fewer than 1,000patients treated.

(5) The mean duration was only six weeks,and trials were all six to twelve weeks induration. It is useful to question trial du-ration when the use of an intervention islonger. Firstly, any shorter trials have beenomitted. In the absence of substantial evi-dence from longer trials, this is the best wehave. In what amounted to a real worldprimary care experiment, only 44% of pa-tients were still taking the treatment towhich they had been randomised by ninemonths. Others either switched to anotherantidepressant or stopped treatment be-cause of adverse effects or lack of efficacy.There is an argument that six to twelveweeks is the window in which issues oflack of efficacy, adverse events, and switch-ing take place, making it the ideal periodtrial duration on which to base decisions.

(6) The clinical significance of the dichoto-mous measure of efficacy is unclear. This isa very old-fashioned argument. Usingmean data is hopeless for all sorts of rea-sons, some of which are rehearsed below.Similar dichotomous outcomes are nowbecoming widely used in other areas, andare proving very useful. This is no morethan a trivial objection; though that doesnot mean that better dichotomous out-comes won't be developed.

(7) No adjustments were made for multiplestatistical testing, another useful point. Onthe other hand, the simplistic approachoutlined in Figure 2 produces much thesame result.

Further commentThis approach has application way beyondjust depression. This has every prospect ofbeing a useful methodological simplifica-

tion and advance that could be used muchmore widely. The use of a dichotomousmeasure of benefit, set at a high level, is inaccord with developing thinking in a num-ber of fields. Combining this with a meas-ure of how many people can take the drughits directly at effectiveness – becausethere's no benefit at all when people can'ttake it.

Changes in average scores usually reflectthe experience of very few patients. More-over, it is common to use last observationcarried forward, meaning that people whodiscontinue can still contribute to efficacymeasures, even when there can be none be-cause they have stopped taking it.

There is one other comment. The authorssuggest that their results make sertralinethe base case – raising the base well aboveplacebo. They raise the question whethersertraline should be the new placebo, or atleast the common comparator for all futuredepression trials.

And finally, the main point in all of this isthat of getting “the best for the most withthe least”. What the meta-analysis providesis the raw material for the next step, namelycreating and testing a care pathway or path-ways for depression that provides good re-sults for the largest number of sufferers inthe shortest time and at the lowest cost.

REFERENCES

1. Cipriani A, Furukawa TA, Salanti G etal. Comparative efficacy and acceptabilityof 12 new-generation antidepressants: amultiple-treatments meta-analysis. Lancet2009;373:748–58.

2. New antidepressant meta-analysis haslimitations. MeReC 2009; Monthly No 13.,April. Available athttp://www.npc.co.uk/ebt/merec/pain/rheum/merec_monthly_no13.html

3. Cipriani A, Santilli C, Furukawa TA, etal. Escitalopram versus other antidepressive agents for depression.Cochrane Database of Systematic Reviews2009, Issue 2. Art. No: CD006532.

4. Cipriani A, La Ferla T, Furukawa TA, etal. Sertraline versus other antidepressiveagents for depression. Cochrane Databaseof Systematic Reviews 2009, Issue 2. Art.No: CD006117.


EVIDENCE-INFORMED DECISION MAKING

http://www.npc.co.uk/ebt/merec/pain/rheum/merec_monthly_no13.html


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

Theory versus practice: discussing thegovernance of health technologyassessment systems

Paul Healy and Meir Pugatch

London: Stockholm Network, 2009

63 pages

Freely available online at:

http://www.stockholm-network.org/downloads/publications/Theory_versus_Practice.pdf

This report gives an overview of governancein the field of Health Technology Assess-ment (HTA) systems. It takes the cases offour countries – Australia, Canada, Ger-many and the United Kingdom - to analysesome of the key elements within HTA sys-tems, and finds that whilst these systemshave much in common, there are still con-siderable differences among them, ulti-mately leading to different outcomes andoutputs.

Aside from describing and analysing eachagency and rationale for HTA, the report’smain aim is to categorise each system underfive separate ideas: their relationship withhealth care decision makers (‘policymak-ing’); the competence of HTA bodies toprovide recommendations of technologies

(‘competence’); the degree of openness andinclusion from various stakeholders (‘accessibility’); output and performance(‘functionality’); and public perception(‘perception’). Having done this, the reportthen recommends that HTA bodies needflexibility to appreciate local and individualconcerns. Further, the authors argue for amore transparent system whereby decisionmaking processes are there for all to see.Once HTA decisions have been made, theirintegration into national health systems arecrucial and must take into account policy actions and budgetary consequences in awider context. Finally, the report urges boththe public and policymakers to keep a critical eye on the system to realise its fullpotential.

Child day care centre or home carefor children aged 12–40 months ofage – what is best for the child?

Edited by Sara Holmgren

Ostersund: Swedish National Instituteof Public Health, 2009

ISBN: 978-91-7257-617-9

40 pages

Freely available online at:

http://www.fhi.se/PageFiles/6290/R2009-09-Child-day-care-center-or-home-care.pdf

In Sweden it is common that both parentswork, full- or part-time. Most childrenwhose parents work are enrolled in day carecentres. Statistics from the Swedish NationalAgency for Education show that in 2008,46% of all twelve to twenty-three monthold children, as well as 85.8 % and 88.8% ofthose aged twenty-four to thirty-five monthsand thirty-six to forty-eight months respec-tively were enrolled in day care centres. In2008, the Swedish government introduced achild-raising allowance to enable parents tostay at home with their children beyond thestandard period of paid parental leave.

With this as a background, the Swedish Na-tional Institute of Public Health conducteda literature review in order to examine whatis the best for the child in the preschool yearsbetween twelve and forty months of age.Child outcomes from day care centres versushome care experiences were captured usingmeasures of cognitive and socioemotionaldevelopment. International studies were included if quality of day care centres were

comparable to those found in Sweden.

The review found four studies that met qual-ity requirements. In two of these studies,day care children demonstrated higher cognitive and language skills at age thirty-sixmonths. Long-term effects of day care centres were demonstrated in both verbaland mathematical ability in eight-year oldchildren. In the other two studies, no sucheffects were detected. No firm conclusionscould be drawn on the effect of day carecentres on socio-emotional development.

Overall the review concludes that day carecentres enhance cognitive development.From a public health perspective, it arguesthat children at risk, and especially childrenfrom poor families, benefit from enrolmentin day care centres. It notes an associationbetween child poverty and poor develop-mental outcomes that can be reducedthrough investment in high quality day carecentres.

Contents: Glossary of acronyms; Executive summary; Introduction; HTA process; HTA systems; Australia; Canada; Germany; United Kingdom; Conclusions and policy considerations; Bibliography

Contents: Foreword; Summary; Introduction; Background; Objectives; Methods; Results;Discussion; Conclusions; Appendices


http://www.stockholm-network.org/downloads/publications/Theory_versus_Practice.pdf

http://www.fhi.se/PageFiles/6290/R2009-09-Child-day-care-center-or-home-care.pdf


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

potential inclusion in future issues.

National Institute for HealthResearch School for SocialCare Research (NIHRSSCR)

http://www.lse.ac.uk/collections/NIHRSSCR

Health and Environment Alliance (HEAL)

http://www.env-health.org

Swedish Presidency of the EU

http://www.se2009.eu

HEAL is an alliance of non-governmental organisations, professional bodies representative of doc-tors and nurses, academic institutions and other not-for-profit organisations. Its mission is to pro-tect the environment as a means of promoting the health of all people living in Europe, as well as toensure the participation of citizens in environmental and health-related policy making at the Euro-pean level. The website outlines challenges, policy implications and priorities, especially in light ofclimate change. A video link to You Tube is also provided, in addition to downloadable publications,newsletters, subscription services and posters of past campaigns. The site is hosted in English only.

European Social Network(ESN)

http://www.esn-eu.org/home/index.htm

ESN, a not-for-profit charitable company established in 1998, coordinates an independent networkof local public social services in Europe. It brings together directors of social work and social careservices working at the local level, in order to bridge the gap between European policy-making andlocal social care practice and management. The English language website contains publications, policy reports and e-newsletters that are available for download. There is also a special section dedicated to social care in central and eastern Europe.

Determine

http://www.health-inequalities.eu

Determine is an EU consortium for action on policies and interventions to promote health equitywithin and between European countries. The website provides an outline of EU and nationalpolicies, databases, a directory of ‘good practice’ and links to upcoming events. Although pages areavailable in English only, some documentation is also available in twelve European languages.

Sweden takes over the presidency of the EU in July 2009. In respect of the social policy, health andconsumer affairs’ web pages on the site, users can browse upcoming events and conferences, as wellas download policy documents related to labour market inclusion, non-discrimination, health and dig-nified ageing, alcohol-related harm and patient rights to health care in the EU. The site can be accessedin English, Swedish and French.

The NIHR School is a partnership between five leading academic centres for social care research inEngland, all of whom have a mission to improve care services and practice. The web site outlines objectives, research areas and visions, as well as activities and ongoing consultations. The news and‘in the media’ sections include links to recent press releases and interviews. Contact details of staffand listings of the advisory board can also be found online.

Alzheimer Europe

http://www.alzheimer-europe.org

Alzheimer Europe is a non profit organisation that aims to improve the care and treatment ofAlzheimer patients through collaborations with member associations in Europe. The web site pro-vides an overview of the disease and the role of national associations. This includes information onthe prevalence of dementia, tips for carers, as well as data on rare forms of dementia and legal rightsin different countries. Reports are also available for download and purchase. Past and futureAlzheimer Europe conference news is presented and an exclusive members’ only area exists. The siteis available in ten European languages.

WEBwatch

http://www.se2009.eu


http://www.lse.ac.uk/collections/NIHRSSCR

http://www.env-health.org

http://www.esn-eu.org/home/index.htm

http://www.health-inequalities.eu

http://www.alzheimer-europe.org


MONITOR

NEWS FROM THE INSTITUTIONS

World Health Assembly heldamid concerns about flupandemicThe 62nd World Health Assem-bly tool place in Geneva from 18to 22 May. In her address to theAssembly, WHO Director-Gen-eral, Dr Margaret Chan notedthat the world was facing multi-ple crises, including the currentfinancial crisis and global eco-nomic downturn. In addition tothis, it also faced the prospect ofthe first influenza pandemic ofthis century. In view of the in-fluenza situation WHO MemberStates earlier agreed to shortenthe Assembly from nine to fivedays.

Dr Chan said that the world to-day was more vulnerable to theadverse effects of an influenzapandemic than it was in 1968,when the last pandemic began.The increase in air travel meantthat any city with an internationalairport was at risk of an importedcase. Global economic interde-pendence amplified the potentialfor economic disruption. Underthese circumstances, it was vitalto see that no part of the worldsuffered disproportionately. “Wehave to care about equity. Wehave to care about fair play,” shesaid.

Dr Chan noted that 85% of theburden of chronic diseases wasconcentrated in low-income andmiddle-income countries, whichmeant that the developing worldhad by far the largest pool of peo-ple at risk for severe and fatalH1N1 infections. She urged theinternational community to lookat everything that could be doneto collectively protect developingcountries from bearing the bruntof an influenza pandemic.

The Director-General said shehad reached out to manufacturersof antiviral drugs and vaccines, toMember States, donor countriesand UN agencies, civil society or-ganisations, nongovernmental or-ganisations, and foundations tostress the need to extend prepara-

tion and mitigation measures tothe developing world. TheUnited Nations Secretary-Gen-eral had joined her in these ef-forts.

Dr Chan also said that concernsabout a pandemic should notovershadow, or interrupt othervital health programmes. She saidthat an effective public health re-sponse to threats depended onstrong health systems that wereinclusive, and offered universalcoverage down to the communitylevel. Adequate numbers oftrained, motivated and compen-sated staff, as well as fair access toaffordable medical products andother interventions were all re-quired for an effective publichealth response to the current sit-uation.

The Assembly closed with theadoption of resolutions. In addi-tion to measures in respect of in-fluenza these included endorsingstrict quality standards for theprovision of anti-tuberculosis(TB) drugs and efforts to limittheir misuse and agreement tostrengthen measures to make ac-cess universal to multi and exten-sively drug resistant (M/XDR)TB diagnosis and quality treat-ment. Research for new TB diag-nostics, medicines and vaccines isalso prioritised under the resolu-tion through support for extra fi-nancing. At the same time, WHOwill also work with MemberStates to develop national TB re-sponse plans that will preventmore people from getting drug-resistant tuberculosis, and diag-nose and treat those that do.

After intense debate, MemberStates also adopted a final plan ofaction on public health, innova-tion and intellectual propertywhich includes an agreed list ofstakeholders who will be in-volved in the process, as well as atime frame and progress indica-tors by which to monitorprogress. The plan of action aims,among other things, to foster in-novation and improve access tomedicines for diseases that dis-proportionately affect the poor.

In respect of the social determi-

nants of health a resolution urgedWHO Member States to showpolitical commitment, “as a na-tional concern”, towards themain principles as set out in theWHO report on the social deter-minants of health; to encouragedialogue among different sectorsof government with a view to “in-tegrating a consideration of healthinto relevant public policies andenhancing intersectoral action”;and to “consider developing andstrengthening universal compre-hensive social protection policies”to ensure that everyone has ac-cess to goods and services essen-tial to health and well-being.

The Assembly also adopted a res-olution on the renewed commit-ment to primary health care, witha particular emphasis on the needto ensure that health systems areadequately financed to ensurecomprehensive health services areavailable to everyone in the con-text of the current internationalfinancial crisis. It urged MemberStates to develop “national equi-table, efficient and sustainable fi-nancing mechanisms” which al-low for universal access toprimary health care; to “to pro-mote active participation by allpeople” through the empoweringof communities, especiallywomen, in the processes of de-veloping and implementing poli-cies; to develop and strengthenhealth information and surveil-lance systems in order to “facili-tate evidence-based policies andprogrammes and their evalua-tion” and to ensure an appropri-ate mix of skills among primaryhealth care staff, to ensure an ef-fective response to people healthcare needs.

Other resolutions include a workplan to scale up WHO’s technicalassistance to countries to assessand address the implications ofclimate change for health andhealth systems, and a call forMember States to formulate na-tional policies, regulations andstandards, as part of comprehen-sive national health systems topromote appropriate, safe and effective use of traditional medi-cine.

New

s

Press releases andother suggestedinformation forfuture inclusion can be emailed tothe editor David [email protected]


The Director General’s speech to the Assembly can be accessed athttp://www.who.int/dg/speeches/2009/62nd_assembly_address_20090518/en/index.html

Further information on proceedingsavailable athttp://apps.who.int/gb/e/e_wha62.html

Fighting Cancer: new European partnership On 24 June the European Commissioncreated the European Partnership for Ac-tion against Cancer. It will focus on ac-tions that can be taken at EU level to moreeffectively prevent and control canceracross Europe. In Europe, one in threepeople will develop cancer in their life-time. This translates to 3.2 million peoplebeing diagnosed with the disease everyyear. Cancer is not equally distributed inEurope and the chances of surviving can-cer differ greatly between countries. Bybringing together all relevant organisa-tions working on cancer, the intention is toidentify gaps, address needs and learnfrom each other.

This represents the latest in a series ofCommission actions related to cancer.Most recently the Commission publishedEuropean guidelines for quality assurancein breast and cervical cancer screening anddiagnosis adopted a Report on the Imple-mentation of the Council Recommenda-tion on cancer screening in December2008.

The new European Partnership will belaunched officially in Brussels in autumn2009. It aims to support countries in theirefforts to tackle cancer by providing aframework for identifying and sharing in-formation, capacity and expertise in can-cer prevention and control. It will engagea wide range of stakeholders, includingnon governmental organisations, re-searchers, patients groups, industry andnational authorities across the EU in acollective effort and with a common com-mitment to addressing cancer. This ap-proach will also help to avoid fragmentedand/or duplicate efforts.

Health promotion and early detection ofcancer

One third of all cancers are preventable,and prevention offers the most cost-ef-fective, long-term strategy for reducingthe burden of cancer. The Partnership alsoaims to put in place healthy lifestyle in-terventions and improved early detectionof cancer, by achieving 100% population

coverage for screening for breast, cervicaland colorectal cancer, which can dramati-cally reduce the impact of the disease andthe loss of lives.

Identification and dissemination of goodpractice in cancer-related health care

By focusing on best practice, the Partner-ship hopes to encourage a multi-discipli-nary and comprehensive approach to can-cer-related healthcare, which will ensure abetter quality of life for cancer patients.This will help to reduce inequalities incancer deaths related to health care be-tween different Member States; the Part-nership is aiming for a 70% reduction by2020.

Priorities for cancer research

The Partnership will work towards de-veloping a more coordinated approach tocancer-related research across the EU,with a particular focus on identifying andtackling discrepancies and obstacles incancer-related research. By doing so, atleast one third of all European research ef-forts should be coordinated by the end ofthe Partnership.

Health information and data

It is important to continuously collect andanalyse information and data on cancer inorder to ensure effective public health in-terventions. To this end, the Partnershipwill examine current obstacles in the col-lection of this necessary information andlook for solutions – by 2013, comprehen-sive data for all Member States should beavailable for the first time.

More information on the new EuropeanPartnership at http://tinyurl.com/mzk9sx

WHO report highlights health sector’scarbon footprintCutting carbon dioxide (CO2) emissionsin the health sector must form part of acomprehensive package of measures tomitigate the impact of climate change atthe December climate conference inCopenhagen according to the WorldHealth Organization (WHO).

A discussion draft report prepared by theWHO and the non-governmental organ-isation Health Care Without Harm, sayshospitals have a major role to play andcan reduce their environmental impact byusing alternative energy sources, designing‘greener’ buildings, and being more effi-cient in their use of water, transport andfood. By ‘shopping green’, the health sec-tor can make its own operations more ef-

ficient and can help leverage broaderchange throughout the economy, accord-ing to the report.

The authors also called on the United Na-tions Climate Change Conference tospecifically promote climate change miti-gation in the health sector. It is suggestedthat prioritising primary health care andpursuing disease prevention strategies, inorder to lower dependence on resource-intensive therapies, can simultaneously re-duce the burden of disease and the healthsector’s fossil fuel consumption.

Several examples of good practice arehighlighted. It notes that the NationalHealth Service in England has taken a leadin this area and proposed a range of meas-ures including offering fewer meat anddairy products on its menus. It calculatesthat it spends £20 billion a year on goodsand services, which translates into a car-bon footprint of 11 million tonnes, 60% ofthe NHS’s total carbon footprint.

Addenbrooke’s Hospital in Cambridge,England, has reduced the number of carson the campus by 16%, with staff car usedown 22%. The health authorities havecommissioned a bus to the hospital, of-fered discounted bus passes and intro-duced interest-free loans for bicycles aswell as a car share scheme. At the PilgrimHospital, Lincolnshire, England, a bio-mass boiler will come into operation nextyear as part of a plan to cut its CO2 emis-sions by 50%. The boiler will run on lo-cally harvested and renewable woodchipsand will be supplemented by a CombinedHeat and Power (CHP) plant which willgenerate electricity for hospital operations.

In Torun City Hospital in Poland im-proved insulation, room temperature con-trol and modern heaters have helped pro-duce energy savings of 30% in renovatedbuildings and 54% in new buildings. AtConstance Hospital in Baden-Württem-berg, Germany, CO2 emissions have beencut by over 25%. The hospital installedsolar panels and CHP technology that has75% efficiency (versus 35% efficiency forconventional generators). In addition,buildings and windows throughout thehospital have been equipped with thermalinsulation.

The report lists seven elements for a cli-mate-friendly hospital:

Energy efficiency: reduce hospital energyconsumption and costs through efficiencyand conservation measures;

Green building design: build hospitals that


MONITOR

http://www.who.int/dg/speeches/2009/62nd_assembly_address_20090518/en/index.html

http://apps.who.int/gb/e/e_wha62.html

http://tinyurl.com/mzk9sx

are responsive to local climate conditionsand optimised for reduced energy and re-source demands;

Alternative energy generation: produceand/or consume clean, renewable energyonsite to ensure reliable and resilient op-eration;

Transportation: use alternative fuels forhospital vehicle fleets; encourage walkingand cycling to the facility; promote staff,patient and community use of publictransport; site health care buildings tominimise the need for staff and patienttransportation;

Food: provide sustainably grown localfood for staff and patients;

Waste: reduce, re-use, recycle, compost;employ alternatives to waste incineration;

Water: conserve water; avoid bottled wa-ter when safe alternatives exist.

Dr Pendo Maro, joint senior climatechange and energy advisor at Health CareWithout Harm and the Health and Envi-ronment Alliance said Europe’s healthsectors have a key role to play in Copen-hagen, “With the world’s governments setto establish a new agreement for address-ing climate change in Copenhagen thisDecember, it is essential that Europe’shealth sector speaks out and puts pres-sure on the EU and our governments toadvocate for a strong stance that addressesthe most serious environmental health is-sue that the world faces today.”

The report can be accessed athttp://www.noharm.org/details.cfm?ID=2199&type=document

European Commission and Russia agreeto strengthen dialogue in public healthOn 28 May in Moscow, European HealthCommissioner Androulla Vassiliou andMinister of Health and Social Develop-ment of the Russian Federation MsTatyana Golikova signed Terms of Refer-ence for establishing a dialogue in publichealth.

This dialogue goes beyond the currenthealth provisions in the EU–Russia Part-nership and Cooperation Agreement. Forexample, it includes the monitoring andcontrol of the spread of HIV/AIDS, tu-berculosis, and other infectious diseases,the promotion of healthy lifestyles to re-duce avoidable premature mortality andstrengthening surveillance the coopera-tion on the development of common foodsafety standards.

Following the signature of these Terms ofReference, Commissioner Vassiliou saidthat “concerted health promotion effortsand an effective collaboration across bor-ders are essential to the future of ourhealth systems. Health challenges, com-mon to Member States and Russia, can bebetter addressed when tackled by joint ac-tions and international initiatives. This di-alogue on public health will contribute tothe current EU–Russia Partnership as wellas to future bilateral relations and to globalhealth initiatives.”

Commissioner Vassiliou and Minister Go-likova also discussed possibilities for im-mediate joint actions related to influenzaA H1N1, youth health, as well as diet andnutrition. The health dialogue is part of awider process of improving EU–Russiancontacts, which was agreed at theEC–Russia summit in 2005.

European Commission steps up actionon Alzheimer’s disease and otherneurodegenerative conditionsThere are currently over seven millionpeople with Alzheimer’s disease (70% ofall dementia cases) and related disorders,including vascular dementia, in Europeand it is predicted that this number willdouble in the next twenty years. In 2005,the total direct and informal care costs ofAlzheimer’s disease and other dementiaswere estimated at €130 billion in theEU27 (€21,000 per patient); 56% of thesecosts were for informal family care.

The European Commission’s 2007 EUhealth strategy ‘Together for Health’ iden-tified the need to better understand neu-rodegenerative diseases such asAlzheimer’s in the context of ageing. Inthe latest move on 22 July 2009, the Eu-ropean Commission adopted concreteproposals to tackle Alzheimer’s disease,dementias and other neurodegenerativeconditions.

EU Health Commissioner Androulla Vas-siliou said that “losing mental capacity todementia is not just a normal part of get-ting older. As the European populationages, we must work together to better un-derstand and prevent these conditions. Wemust show our solidarity to people withdementia by sharing best practice in caringfor them and respecting their rights anddignity.”

EU Science and Research CommissionerJanez Potocnik said that “we want to helpresearch play a bigger role in tackling suchsocietal challenges as Alzheimer’s and re-

lated disorders. The Commission alreadyhas a track record of supporting Euro-pean research projects with the best sci-entists in this area. But we will see a majorstep ahead if Member States now start co-ordinating their national programmesaround a common agenda”.

The Commission proposes four main ar-eas of action: acting early to diagnose de-mentia and to reduce the risk of dementiain the first place; improving research co-ordination between EU countries; sharingbest practice; and providing a forum toreflect on rights, autonomy and dignity ofpatients.

Alzheimer’s disease and related disordershave been identified by EU Member Statesas an area where the first Joint Program-ming of research activities should belaunched. Joint Programming addressesEU countries willing to engage in the de-velopment of a common Strategic Re-search Agenda which will allow their par-ticipation on a variable geometry basis.Twenty countries have already showntheir willingness to pool resources and toconduct research in an area where a com-mon initiative would offer major addedvalue compared with the current, frag-mented research efforts in Europe.

The Commission Communication on aEuropean Initiative on Alzheimer’s disease and other dementias is availableat http://ec.europa.eu/health/ph_information/dissemination/diseases/alzheimer_en.htm

Antitrust: shortcomings in pharma-ceutical sector require further actionMarket entry of generic drugs is delayedand there is a decline in the number ofnovel medicines reaching the market, ac-cording to the European Commission’sfinal report on competition in the phar-maceutical sector.

The inquiry began in January 2008 to ex-amine the reasons why fewer new medi-cines were brought to market and whygeneric entry seemed to be delayed insome cases. The goal was to find waysthat help the market work better. Tensionshave been high between the industry andthe Commission following a dramatic se-ries of unannounced raids on the offices oftop pharmaceutical companies in Januaryand November 2008. A preliminary re-port published in November 2008 allegedthat anti-competitive practices in the sec-tor were hampering innovation and block-ing the entry of cheap generics onto the


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European market.

More than seventy submissions were re-ceived from stakeholders. Consumer as-sociations, health insurers and the gener-ics industry welcomed the results, arguingthat they confirm their concerns. Theoriginator industry and their advisors sup-ported the call for the creation of a Com-munity Patent and a specialised litigationsystem, whilst arguing that generic delayand the decline in innovation had beencaused by regulatory shortcomings.

The final sector inquiry report representsa shift in tone. It suggests that companypractices are among the causes, but doesnot exclude other factors such as short-comings in the regulatory framework. Asa follow up, the Commission intends tointensify its scrutiny of the pharmaceuti-cal sector under EC antitrust law, includ-ing continued monitoring of settlementsbetween originator and generic drug com-panies. The first antitrust investigationsare already under way. The report alsocalls on Member States to introduce legis-lation to facilitate the uptake of genericdrugs and notes near universal supportamongst stakeholders for a CommunityPatent and specialised patent litigationsystem in Europe.

Main findings and policy conclusions

The inquiry has contributed significantlyto the debate on European policy forpharmaceuticals, in particular for genericmedicines. On the basis of a sample ofmedicines that faced loss of exclusivity inthe period 2000–2007 in seventeen Mem-ber States, the inquiry found that citizenswaited more than seven months afterpatent expiry for cheaper generic medi-cines, costing them 20% in extra spending.

Generic delays matter as generic productsare on average 40% cheaper two years af-ter market entry compared to the origina-tor drugs. Competition by generic prod-ucts thus results in substantially lowerprices for consumers. The inquiry showedthat originator companies use a variety ofinstruments to extend the commercial lifeof their products without generic entryfor as long as possible.

The inquiry also confirms a decline ofnovel medicines reaching the market andpoints to certain company practices thatmight contribute to this phenomenon.Further market monitoring is ongoing toidentify all the factors that contribute tothis decline in innovation.

Reacting to the findings, the Commission

will apply increased scrutiny under ECTreaty antitrust law to the sector and bringspecific cases where appropriate. The useof specific instruments by originator com-panies in order to delay generic entry willbe subject to competition scrutiny if usedin an anti-competitive way, which mayconstitute an infringement under Article81 or 82 of the EC Treaty. Defensivepatenting strategies that mainly focus onexcluding competitors without pursuinginnovative efforts will remain underscrutiny.

To reduce the risk that settlements be-tween originator and generic companiesare concluded at the expense of con-sumers, the Commission will carry outfurther focused monitoring of settlementsthat limit or delay the market entry ofgeneric drugs. In the case of clear indica-tions that a submission by a stakeholderintervening before a marketing authori-sation body was primarily made to delaythe market entry of a competitor, injuredparties and stakeholders are invited tobring relevant evidence of practices to theattention of the relevant competition au-thorities.

On regulatory issues the inquiry foundthat there is an urgent need for the estab-lishment of a Community patent and aunified specialised patent litigation sys-tem in Europe to reduce administrativeburdens and uncertainty for companies. Afull 30% of patent court cases are con-ducted in parallel in several MemberStates, and in 11% of cases in nationalcourts reach conflicting judgements.

Recent initiatives of the European PatentOffice (EPO) to ensure a high qualitystandard of patents granted and to accel-erate procedures are welcome. This in-cludes measures taken in March 2009 tolimit the possibilities and time periodsduring which voluntary divisional patentapplications can be filed.

As a result of the inquiry the Commissionis also urging Member States to ensurethat third party submissions do not occurand in any event do not lead to delays forgeneric approvals. It also urges them tosignificantly accelerate approval proce-dures for generic medicines, take action ifmisleading information campaigns ques-tioning the quality of generic medicinesare detected in their territory, and stream-line trials that test the added value of novelmedicines.

To assist Member States in deliveringspeedy generic uptake and improved price

competition, the report contains anoverview of national measures and theireffects on generic uptake (volume, prices,number of entrants) and encourages Mem-ber States that want to benefit fromgeneric savings to consider such measures.In this light the Commission will also ex-amine existing EU rules in the area of pric-ing and reimbursement (Transparency Di-rective 89/105/EEC).

Reaction

Speaking on the publication of the reportCompetition Commissioner Neelie Kroessaid that “we must have more competitionand less red tape in pharmaceuticals. Thesector is too important to the health andfinances of Europe’s citizens and govern-ments to accept anything less than thebest. The inquiry has told us what iswrong with the sector, and now it is timeto act. When it comes to generic entry,every week and month of delay costsmoney to patients and taxpayers. We willnot hesitate to apply the antitrust ruleswhere such delays result from anticom-petitive practices. The first antitrust in-vestigations are already under way, andregulatory adjustments are expected tofollow dealing with a range of problems inthe sector.”

Arthur J Higgins, Chief Executive OfficerBayer Healthcare and president of the Eu-ropean Federation of Pharmaceutical In-dustries and Associations, welcomed thereport and focused on streamlining intel-lectual property infrastructure saying that“we have stated consistently that complexand divergent regulatory barriers are theprimary cause of market entry delay forboth generic and innovative medicines.We are pleased that the final report recog-nises this reality.”

“We welcome many of the policy recom-mendations, such as a more streamlinedpatent system that reduces costs and in-creases legal and commercial certainty. Wecommit to working constructively withthe internal market commissioner, mem-ber states, and the European Patent Officeto push reforms forward under theSwedish Presidency. What is important isthat the Commission uses this report toaddress the issue of competition in theoff-patent market. This is an area that cangenerate savings which could be rein-vested to fund innovative medicines.”

Greg Perry, Director General of the European Generic Medicines Associationalso welcomed the “importance given bythe European Commission to the need of


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high quality patents and raising the barfor patent applications. The existence ofcertain dubious secondary patents has indeed created a block against competitionand undermined confidence in real inno-vation.” He reiterated the need for urgentreform in the pharmaceutical sector, call-ing for Europe’s legislative framework tobe tightened in the areas of patent law,pharmaceutical legislation, price and re-imbursement rules and competition law.

Monique Goyens, director-general of Eu-ropean consumer organisation BEUC,said the sector inquiry shows the phar-maceutical industry is not working prop-erly and that “vicious tactics” are used todelay or prevent the entry of more af-fordable and innovative medicines intothe market. “Millions of euros are spent inpromotional activities, in legal disputesand settlement agreements instead of inthe development of new medicines to meetpatients’ needs,” Goyens said. She calledfor concrete actions at EU and memberstate level to address unethical practices.

The final report and other documenta-tion are available at http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/index.html

Health Council conclusionsAt a meeting of the EU Health Ministersat the Council of the European Union inLuxembourg on 8 and 9 June EU healthministers have adopted a recommenda-tion on patient safety, including preven-tion and control of health-care related in-fections. The objective of the proposals isto support national-level implementationof prevention strategies and programmesand control of undesirable events and in-fections related to health-care providers.Member States have been asked to developcommon definitions and terminology onpatient safety which can be shared, andalso to establish a set of reliable and com-parable indicators, to identify safety prob-lems, to evaluate the effectiveness of in-terventions aimed at improving safety andto facilitate mutual learning in this area.

The Council also adopted a recommenda-tion on an action in the field of rare dis-eases which aims to provide a coordinatedEU approach to ensure effective recogni-tion, prevention, diagnosis, treatment, careand research in the field of rare diseases inEurope.

The Health Ministers also held a publicdebate on the issue of cross-border health-care in an attempt to provide a platform

for ministers from Member States to dis-cuss their existing concerns about the di-rective. Despite an overall consensusabout the need for cooperation in the fieldof health care, ministers still had worriesabout the need for prior authorisation, thelegal basis for the proposals and the issueof long-term care. The first round of ne-gotiations may have concluded but thereremains a lot of work to be done in orderto reach agreement on these proposals.

Pharmaceutical package

On the basis of three progress reportsfrom the Presidency, the Council held anexchange of views on the legislative pro-posals forming the ‘Pharmaceutical pack-age’. With regard to preventing falsifiedmedicinal products from entering the legalsupply chain, ministers broadly welcomedthe proposal, highlighting the importanceof the draft directive for the safety of me-dicinal products.

The discussions in the responsible Coun-cil working group have shown that dele-gations consider the Commission pro-posal to be a good basis for improving theexisting directive on medicinal productsfor human use as regards protectionagainst falsified medicinal products. How-ever, individual elements of the proposalneed further discussion. This concernsparticular definitions, for example, of ‘fal-sified medicinal products’, the scope ofthe proposal and the safety features.

Concerning ‘pharmacovigilance’, i.e. thestrengthening of the EU system for safetymonitoring of medicinal products, minis-ters warmly welcomed the Commissionproposals for a regulation and a directive,and highlighted their contribution to theprotection of patients. Initial discussionsin the responsible Council working groupshow however, that continued examina-tion of the proposals is necessary, in par-ticular with regard to the composition,role and mandate of the proposed Phar-macovigilance Committee and its interac-tion with other preparatory bodies of theEuropean Medicines Agency (EMEA).

As regards the proposed regulation anddirective concerning provision of infor-mation by marketing authorisation hold-ers, many ministers expressed concernsthat had already been raised in the work-ing group. While agreeing that there is aneed to improve the information to thegeneral public on prescription-only me-dicinal products, many delegations fearthat the suggested system will be overlyburdensome for competent authorities

without leading to significant improve-ments in the quality of the informationprovided to patients. In addition, manydelegations hold that the distinction be-tween ‘information’ and ‘advertising’ isnot sufficiently clear and therefore fearthat the proposals will not provide suffi-cient guarantees that the prohibition ofadvertising of prescription-only medicinalproducts to the general public will not becircumvented.

All five proposals are based on Article 95of the Treaty (internal market); qualifiedmajority required for a Council decision;co-decision procedure. The first-readingopinion of the European Parliament is ex-pected at the earliest in the autumn of2009.

More information athttp://tinyurl.com/mrgqfo

NEWS FROM THE EUROPEAN COURTOF JUSTICE

ECJ: Can a risk to health turn a foodsupplement into a medicinal product?On 30 April 2009, the ECJ issued a judg-ment relating to the classification of bor-derline products (C-27/08, BIOS Natur-produkte GmbH v Saarland) whichfurther clarifies and harmonises the clas-sification criteria for borderline productsin the EU.

The plaintiff, BIOS NaturprodukteGmbH, a company marketing severalfood supplements in Germany, placed theproduct in question on the German mar-ket as a food supplement. German au-thorities prohibited BIOS from continu-ing to offer the product on the groundthat it was a medicinal product which hadnot received prior marketing authorisa-tion. Scientific research had shown thatthe recommended daily dose of the prod-uct was unable to produce therapeutic ef-fects but on the other hand posed a certainrisk to health since it could have the effectof aiding inflammatory processes.

The company challenged the authorities’decision but their appeal was rejected.When the case came before the GermanFederal Administrative Court Bundesver-waltungsgericht), the court proceedingswere stayed and a ruling was requestedfrom the ECJ on whether Article 1 (2) ofDirective 2001/83 must be interpreted tothe effect that a product intended for hu-man consumption and described as a food


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supplement is a medicinal product byfunction if it contains substances whichpose a risk to health in a low dose, with-out being capable of producing therapeu-tic effects, but which have therapeutic ef-fects in high doses.

The ECJ stressed that national authori-ties must decide upon the classification ofsuch borderline products on a case-by-case basis, taking into account all the char-acteristics of the product, in particular itscomposition, its pharmacological, im-munological or metabolic properties. Themere fact that the use of a product presentsa ‘risk to health’ is not an indication thatthe product has pharmacological effectsand, thus, must be classified as a medicinalproduct. The ECJ concluded that a prod-uct which includes in its composition asubstance that has physiological effectswhen used in a particular dosage, is not amedicinal product by function where,having regard to its content in active sub-stances and under normal conditions ofuse, it constitutes a risk to health without,however, being capable of restoring, cor-recting or modifying physiological func-tions in human beings.

More information on the judgement athttp://tinyurl.com/kmyloj

COUNTRY NEWS

Russia: President surprised at level ofalcoholismAs reported by the Moscow Times on 2July, President Dmitry Medvedev has ex-pressed surprise at how much alcoholRussians drink and ordered the govern-ment to develop a programme to discour-age drinking. “The alcohol consumptionwe have is colossal.” According to a tran-script on the Kremlin’s website, Medvedevtold Health and Social Development Min-ister Tatyana Golikova at recent meeting,that he was “astonished to learn that wenow drink more than we did in the 1990s,although those were very tough times.”

He told Golikova to devise an anti-alcoholstrategy. “We need to prepare a corre-sponding programme and take appropri-ate measures.” His statement comes soonafter a report in The Lancet said alcohol-related diseases caused about half of alldeaths of Russians between the ages of 15and 54 in the 1990s.

Prime Minister Vladimir Putin also high-lighted the problem at a meeting with the

World Health Organization DirectorGeneral in June and promised to promotea healthier lifestyle. Also lending his sup-port for action, former Soviet leaderMikhail Gorbachev, who initiated a 1986anti-alcohol campaign that led to a boomin illegal production of low-quality alco-hol, said that “we are destroying ourselves,and then we will look for those who de-stroyed our country, for those who madeus drink.”

More at http://www.moscowtimes.ru/article/1010/42/379218.htm (subscribersonly)

Czech Republic: User fees generatesubstantial revenuesDuring its first year of implementation,user fees in the Czech Republic broughtten billion Czech Crowns worth of sav-ings and income to the health care system(five billion was collected in user fees andanother five billion represents accumu-lated savings within the system). Healthinsurance companies used these resourcesto finance modern and up-to-date treat-ments. In addition, these financial re-sources enabled access to previously inac-cessible and expensive treatment for theseriously ill, brought effective and moderntreatment into specialised centres, in-creased the number of surgeries, reducedwaiting times and increased resources foremergency services. User fees improvedgeneral access to health care facilities, freedup overfilled waiting rooms, and there-fore increased the comfort of patients.Emergency services were no longer mis-used, opening up care to those who trulyrequired their services.

The expectations of the Czech Minister ofHealth have been fulfilled: user fees servefor the better use of public health re-sources and redirect money towards thosewith highest need, and help to reduce unnecessary physician visits. The numberof emergency visits dropped by 36%, ambulatory specialist visits by 15% andambulatory specialist visits in inpatient facilities by 19%. In addition, the numberof prescriptions fell by 28% and expendi-tures on drugs costing up to 150 CzechCrowns decreased by 19%.

Minister of Health, Daniela Filipiová,spoke of the benefits of user fees for pa-tients stating that “user fees have made itpossible to limit wastage in the health caresystem, save resources for cheap drugsand use them for treating severely ill patients. In specialised centres (where patients with cancer, multiple sclerosis and

other serious diseases are treated), 40%more patients were treated than in 2007.Coverage of drug expenditures in the spe-cialised centres increase by 47%, and thenumber of hip and knee replacements paidfor by the General Health InsuranceCompany increased by 35%. At the sametime user fees serve as an effective anti-crisis measure.”

The impact of user fees on limiting excessemergency and ambulatory specialist vis-its, and inpatient days appears stable andpermanent. Moreover, in the area of drugconsumption, the effect of reduced ex-penditures on cheap drugs such as aspirinis on-going and has enabled health insur-ance companies to improve access to mod-ern and effective treatment in specialisedcentres. “Due to behavioural changes byall, the billion crown savings can be usedfor previously inaccessible or prohibi-tively expensive treatment for the seri-ously ill” said Marek Šnajdr, the firstdeputy of the ministry of health. He con-tinued, “user fees are closely connectedwith a protection limit which protectsmainly chronic patients and patients suf-fering from more than one disease. Treat-ment expenditures have been reduced for18,700 insurees. Whilst user fees are notpopular, they have increased the confi-dence of our citizens, ensuring that whenthey, or their relatives, become seriouslyill, they will have access to timely, modernand effective treatment.”

More information in Czech athttp://tinyurl.com/mfq5v8

Spain: Pharmacy associations fined bySpanish Competition Authority On 24 March 2009, in Decision 649/08,the Spanish Competition Authority imposed a €1 million fine on four phar-macy associations – Spanish Federationof Pharmacists (FEFE), Confederation ofPharmacies of Andalucía (CEOFA), Professional Association of Pharmacies ofMálaga (PROFARMA) and the Profes-sional Association of Pharmacies of Sevilla(APROFASE) – because they had inducedtheir members to refrain from acquiringcertain generic medicines from the pharmaceutical company LaboratoriosDavur.

Davur had published advertisements indifferent specialised magazines in 2007stating that the price of its generic medi-cines was lower than the price establishedin the Ministerial Order that sets the ref-erence price of generic medicines subjectto medical prescription. The four phar-


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macy associations had made certain announcements in specialised magazinesand had circulated certain communica-tions amongst their members regardingthe lowering of the prices by Davur. Ingeneral terms, the associations indicatedthat the voluntary lowering of the price ofDavur’s generic medicines would lowerthe reference prices for the coming year.

The publications and communications be-tween the associations and their membersalso reminded pharmacists that, pursuantto Spanish legislation, pharmacies are notobliged to sell the cheapest medicines onthe market. Instead, they are obliged tosell the lowest-price medicines accordingto Annex 5 of the Ministerial Order,which sets the reference price of genericmedicines subject to medical prescription,or in case it is the same price, they have tosell the generic medicine (which wouldexclude Davur’s medicines). It was notedthat different pharmacies had decided togive up buying generic medicines fromDavur and had informed them that theyceased commercial relationships, as phar-macists work with a percentage on the final sale price.

The Spanish Competition Authority con-cluded that the four pharmacy associa-tions had carried out a collective recom-mendation prohibited by Article 1 of theSpanish Competition Act (Law 15/2007).The collective recommendation was madeto coordinate the behaviour of all thepharmacies so that they would cease ac-quiring the generic medicines marketedby Davur.

Ireland: Health Minister seeks deliveryof cost effective colorectal cancerscreening programmeOn 17 June the Minister for Health andChildren, Mary Harney, announced thatshe has asked the Health Information andQuality Authority (HIQA) to identify in-novative ways of introducing a nationalprogramme of colorectal cancer screen-ing in Ireland. The introduction of thisscreening programme is now a priority.

Welcoming publication of two related re-ports – the National Cancer ScreeningService’s (NCSS) Expert Report on Col-orectal Screening and the Health Tech-nology Assessment (HTA) carried out byHIQA, the Minister said “I want to in-troduce a national programme of colorec-tal cancer screening as soon as possible.Colorectal cancer kills over 900 people inIreland every year. The expert reportsconfirm that a properly organised screen-

ing programme would have huge publichealth benefits and I want to find innova-tive ways of putting that in place”.

In Ireland colorectal cancer is the secondmost frequently diagnosed cancer in men,after prostate cancer and the second mostfrequently diagnosed cancer in women,after breast cancer. The new cases of col-orectal cancer in Ireland – around 2,000per year – rank among the highest in west-ern Europe for both men and women, andthe death rate is higher for men in Irelandthan elsewhere in Europe.

The purpose of the HTA was to evaluatethe cost-effectiveness of various optionsfor a population-based colorectal cancerscreening programme in Ireland and alsoto estimate the resource requirements andhealth outcomes that would result in thefirst decade following the implementationof such a programme.

Dr Patricia Harrington, Acting Directorof HTA with HIQA said “the results ofthe HTA clearly show that lives can besaved through the introduction of thisscreening programme and the associatedhigher detection rate of colorectal cancerat an early stage. The recommended pro-gramme would be highly cost-effective,when compared with a policy of noscreening. Specifically, a programme basedon faecal immunochemical testing (FIT)every two years for people aged 55 to 74years was found to be the optimal strategyand it would provide the greatest healthgain, while remaining highly cost-effective.” Dr Harrington also stated that“the Authority’s advice to the Minister inrecommending a screening programmebased on FIT every two years would re-sult in a 14.7% reduction in the incidenceand 36% reduction in mortality from colorectal cancer.”

The Minister has asked HIQA to report toher by the end of September. In the timelimited study, HIQA will explore differentways of delivering a high quality colorec-tal screening programme within existingresources, based on the range of advicecontained in the two expert reports.

Minister Harney said that she was“pleased that HIQA has agreed to use itsskills and expertise to set out how the Irishhealth care system can deliver this impor-tant programme within existing re-sources”. The Minister also welcomed thecommitment of the Irish Cancer Societyto play a very supportive role in the designof an appropriate, high-quality screeningprogramme.

The NCSS expert report is available athttp://www.rte.ie/news/2009/0617/NCSScancer.pdf

The HIQA report is available athttp://www.hiqa.ie/news_releases/090617_HTA_colorectal_cancer_screening_programme.asp

Scotland: Launch of mental healthimprovement programmeScotland’s mental health improvementplan was launched on 7 May indicatingthat an understanding of the importanceof protecting a person’s own mental healthcould be key to reducing the number ofpeople with mental health problems. Pub-lic Health Minister, Shona Robison, saidthat good mental health can bring a health-ier lifestyle, better physical health, betterrelationships with family and friends andgreater productivity in the workplace.

Plans for mental health improvement in-clude national marketing campaigns rais-ing awareness of how adults and youngpeople can promote their own wellbeing,aided by self-help resources and practicalsupport. There will also be awareness rais-ing and help for older people to spot theearly signs of dementia and get earlier di-agnosis and training for health and socialworkers on how best to promote mentalwellbeing in children and young people.

There is also a focus on the links betweenphysical and mental health – help to stopsmoking, be more active and eat healthier,as well as on promotion of wellbeing inthe workplace – focusing on the preven-tion of common mental health problems,retaining people in work when they expe-rience mental health problems and helpingthose out of work, due to mental illness,back into work

Additional objectives are for research tobuild a clear picture of all the key factorsthat lead to suicides, creation of a secure,confidential suicide register for Scotlandand to improve knowledge and under-standing of self-harm and guidance forservices to aid treatment and prevention

Ms Robison said “we want to create amore successful Scotland with a thrivingsociety that offers everyone the opportu-nity to reach their full potential. Promot-ing good mental wellbeing, reducing theoccurrence of mental health problems andimproving the quality of life of those ex-periencing mental health problems is vitalto doing just that. Our immediate aim is tohelp everyone to understand how theirown and other’s mental health can be


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improved and create a step-change in howwe, as a society, look after our mentalhealth.”

The report entitled ‘Towards a MentallyFlourishing Scotland: Policy and ActionPlan 2009–2011’ is available athttp://www.scotland.gov.uk/Publications/2009/05/06154655/5

England: publication of consultationdocument on reform of long-term careJuly saw the publication by the Depart-ment of Health in England of the longawaited consultation paper on the futurefunding of long-term care. Shaping theFuture of Care Together sets out a visionfor a new care and support system, it high-lights the challenges faced by the currentcare system and the need for radical re-form, to develop a national care servicethat is fair, simple and affordable foreveryone.

Under the current funding system thegovernment only provides social care tothose on low incomes, leaving others topay for care with no support from thestate until they have only £23,000 left. Theissue is of particular importance given pro-jections that by 2026 there will be 1.7 mil-lion more adults in England in need ofcare and support.

Three options have been proposed. Underthe first option, Partnership, which thegovernment recommends should be thefoundation of the new system, the gov-ernment would pay for around a quarterto a third of the cost of a person’s care andsupport (or more if they have a low in-come). This would leave an individualpaying an average £20,000–£22,500 undera basic partnership scheme, though somewould pay far more.

The second option, Insurance, wouldbuild on this model, with the governmentmaking it easier for people to take out in-surance to cover their remaining costs.The final option, Comprehensive, wouldmean that everyone received free care inreturn for paying into a state insurancescheme. The paper warns that its favouredpartnership option “does not fully protectpeople against the risk of having to payhigh costs towards their care and support”and that a small number of people couldstill be forced to sell their homes to pay forcare.

If the second option were implemented,the government has said that it could workwith the private insurance industry, or setup a state-backed insurance system. With

the government paying around a quarteror a third of costs, it is envisaged that thecurrently prohibitively high premiumscould be reduced. This option is presentedas that most likely to appeal to those keento protect their estate and pass it on to de-pendants. However, there is a risk thatfew people would join a voluntaryscheme. Andy Burnham estimated a take-up rate of around 20% and suggested thatcover would cost between £20,000 and£25,000.

Under the third option, everyone over theage of 65 would be required to make acontribution, either set at one level ormeans-tested. This could prove cheaperthan the voluntary insurance scheme givenits mandatory nature, but would meanthat some people who never required carestill had to contribute. The paper suggeststhat people could make a contribution asa lump sum from savings, defer their statepension and use that money to pay intothe scheme, pay in instalments throughouttheir retirement or defer the whole pay-ment until they died. The cover wouldcost between £17,000 and £20,000, according to Health Minister, Andy Burn-ham, reflecting the larger risk pool thanthat generated by option two. The paperrules out a tax-funded system, whichAndy Burnham said would put an unfairburden on the shrinking proportion ofworking age people, who would need topay high contributions to pay for those inneed of care.

All parties agree that the scale of the chal-lenge is considerable. A 65-year-old canexpect to need care costing on average£30,000 during their retirement. Howeverthis figure conceals great variation in needand cost. 20% of people will need carecosting less than £1,000 during retirementbut another 20% will need more than£50,000-worth of care. Some people couldface a bill of more than £100,000.

Introducing the paper to Parliament, MrBurnham said these were “radical and se-rious proposals” that required a broad,cross-party consensus. However, ShadowMinister for Health, Andrew Lansley, saidministers had “dithered for months”about the paper and said the long-awaitedpublication failed to clarify where thefunding for the state’s contribution to carewould come from. He said “we do notneed a nationalisation of social care serv-ice” and accused the government of takinglocal government out of the equation. Lib-eral Democrat health spokesman NormanLamb said the paper came “twelve years

too late”. He warned that, given the prox-imity of a general election that there was areal risk of any reform being postponed.

Other reactions to the Green Paper havebeen mixed, recognising that many toughdecisions lay ahead. Stephen Haddrill, theABI’s director general, said that “the cur-rent funding situation is not sustainable,and given that the government has madeclear that no extra money is available, theprivate sector has an essential part to playin meeting the growing need for care. Theinsurance industry stands ready to workalongside the Government to provide arealistic and sustainable solution.”

But Ian Owen, chairman of Partnership,the only private sector member of the De-partment of Health’s stakeholder panelwhich advised on the paper and one ofonly two providers of immediate needsannuities, described it as a “major disap-pointment.”

Owen said that “the fact that no newfunding is being offered means that the£6 billion care funding gap identified inthe Wanless report on funding long termcare is no closer to being bridged. Indeed,with our ageing population, the gap willonly grow over time.” He said that thepublic’s attitude required a “completeoverhaul” and that existing insurance-based products had a “crucial role” to playin encouraging people to make provisionfor their retirement.

A spokesman for the insurer Aviva saidthat “our experience is that it is a challengeto persuade people to think about the pos-sibility of needing care. As a result we feelit could be extremely difficult to encour-age people to pre-fund for long term careand would caution the Governmentagainst over reliance on this form of fund-ing.” Aviva is suggesting that changes aremade to the way in which pensions, savings and property are used to fundlong-term care.

The consultation runs until 13 Novem-ber. Respondents are invited to com-plete/participate in a variety of ways. Thisincludes a series of thirty-six stakeholderevents held between July and October,four in each NHS region. These will besupported by public consultation activitiesin town centres where events are beingheld.

The Green Paper is available athttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_102338


MONITOR

http://www.scotland.gov.uk/Publications/2009/05/06154655/5

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_102338

European Commission promotes cycling as healthy way to travelThe European Commission promotedcycling as a healthy and safe way totravel in cities at the 15th Velo-City conference, organised by the BrusselsRegion. Vice-President Kallas, Commis-sioner for Administrative Affairs helpedto sign the Brussels Charter committingvarious cities to promote the use ofbicycles. To promote safe cycling, theEU already helps to fund the develop-ment of cycle infrastructure, for examplethrough the EU's Structural and Cohe-sion Funds. For the period 2007–2013,an estimated budget of more than €600million will be used to invest in cycleinfrastructure in eligible regions acrossthe EU.

More information on Velo-City 2009 athttp://www.velo-city2009.com/index-en.html

INPES ‘Prevention Days’ 2009 a successAlmost 1300 people took part in the‘Prevention Days’ event, organised bythe French National Institute for Dis-ease Prevention and Health Education(INPES) in Paris. A total of 150 experts,including thirty-five representativesfrom other countries, took part in ninethemed workshops over two days. Theestablishment in June by the FrenchNational Assembly of Regional HealthAgencies (ARS) was also noted as a keystep in defining the importance of healtheducation. “It makes the therapeuticeducation of patients an integral part ofmanagement and care,” said FrenchMinister for Health and Sport RoselyneBachelot-Narquin, opening the event.

More information (French only) athttp://www.inpes.sante.fr/

Towards better information sharingon diabetesThe Best Information through RegionalOutcomes (BIRO) Project has pub-lished the outcomes of the initiative in anew report which looks at attempts tobuild a common European infra-structure for standardised informationexchange on diabetes care. The resultsfrom the project mean that the BIROsystem is ready to be rolled out to a network of clinical units, regions andMember States. Its development

furthers progress towards the creation ofa European Diabetes Register.

More information athttp://eubirod.eu/home.htm

Active and dignified ageingIn Luxembourg in June the EUEmployment, Social Policy, Health andConsumer Affairs Council adopted a series of recommendations which seekto establish the conditions “for theactive life and dignified ageing of womenand men”. Among the recommendationsfor measures to be implemented at thenational level are the creation of activeageing policies for older workers; effortsto support employers in their efforts torecruit and retain older workers inemployment; and measures to addressthe needs of older people, includingolder women living alone, in order toreduce their isolation and to promotetheir independence, equality, participa-tion and security.

More information at http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/108375.pdf

Sweden: Protecting the mental healthof young peopleThe Swedish Association of LocalAuthorities and Regions (SALAR) haspublished a position paper on mentalhealth, children and young people whichis now available in English. The paperconsists of sixteen standpoints andargues that joint efforts must be madeby all of the social stakeholders con-cerned to promote the health of childrenand young people, deal with mental illness and alleviate the consequences ofmental health problems.

The paper can be downloaded athttp://tinyurl.com/l5mn93

NICE guidance on managing long-term sickness absence and incapacityfor workThe National Institute for Health andClinical Excellence (NICE) in Englandhas published guidance on managinglong-term sickness absence and inca-pacity for work. Three of the recom-mendations aim to help employers andemployees work together to ensure theright support is available to helpsomeone on sickness absence return towork as soon as they are able. They

include a recommendation for identi-fying someone who is suitably trainedand impartial to undertake initialenquiries with an employee who is expe-riencing long-term sickness absence orrecurring short- or long-term sicknessabsence, and if necessary, to then arrangefor a more detailed assessment by rele-vant specialist/s. The guidance also rec-ommends that those who are unem-ployed and claiming incapacity benefitshould be offered an integrated pro-gramme of support to help them enteror return to work. This advice is aimedat the Department for Work and Pen-sions in England and other relevantcommissioning bodies and organisa-tions.

More information athttp://www.nice.org.uk/Guidance/PH19

More voluntary donations of bloodneeded in EuropeAlthough safe blood donations in theWorld Health Organization (WHO)European Region are rising, theinfluenza pandemic puts extra strain onthe pool of people who give blood. AsWorld Blood Donor Day 2009 wasbeing launched on 15 June in Mel-bourne, Australia, the WHO RegionalOffice for Europe noted that morepeople should be encouraged to donateregularly on a voluntary, non remuner-ated basis; 90% of those who could giveblood are not doing so. At least twentyto twenty-five donations per 1,000 pop-ulation are needed to maintain bloodsupplies, but donation rates per countryacross Europe region range from justfour to sixty-eight per 1,000 population.Indeed due to the shortage of blood andageing populations, the age limits forblood donation acceptability arebecoming increasingly flexible: in someEuropean countries they are now as lowas seventeen and as high as seventy.

More information athttp://www.wbdd.org/

eurohealth Vol 15 No 2 44

News in Brief

Additional materials supplied by

EuroHealthNet

6 Philippe Le Bon, Brussels.Tel: + 32 2 235 03 20Fax: + 32 2 235 03 39Email: [email protected]

http://www.velo-city2009.com/index-en.html

http://www.inpes.sante.fr/

http://eubirod.eu/home.htm

http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/108375.pdf

http://tinyurl.com/l5mn93

http://www.nice.org.uk/Guidance/PH19

http://www.wbdd.org/


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