HEALTH

Eurohealth
RESEARCH • DEBATE • POLICY • NEWS Volume 15 Number 4, 2009
Periodic health examination:

history and critical assessment
Zsuzsanna Jakab: building a healthier, safer, fairer and greener Europe
Comparative clinical effectiveness, drug development and regulatory policy
The EU School Fruit scheme: integrating public health into mainstream policy
Wales: policy development for older people • Child and adolescent mental health in Europe
Poland: hospital privatisation • Community pharmacy regulation • England: evidence for social care
Eurohealth
C
Periodic health checks:
handle with care LSE Health, London School of Economics and Political
Science, Houghton Street, London WC2A 2AE, UK
“Periodic health checks and screening are now very fax: +44 (0)20 7955 6090
http://www.lse.ac.uk/collections/LSEHealth
popular procedures. A priori they should be effective in
O
reducing the burden of disease and improving wellbeing. Editorial Team
Unfortunately the reality seems to be less attractive.” So EDITOR:
writes Walter Holland in his brief history and critical David McDaid: +44 (0)20 7955 6381
assessment of periodic health examinations that features email: d.mcdaid@lse.ac.uk
in this issue of Eurohealth. Such tests may appear FOUNDING EDITOR:
Elias Mossialos: +44 (0)20 7955 7564
attractive to the public and politicians alike; in recent
email: e.a.mossialos@lse.ac.uk
M
years there has been an increase in the marketing of what
DEPUTY EDITORS:
can often be quite expensive diagnostic tests. While some Sherry Merkur: +44 (0)20 7955 6194
periodic health checks undoubtedly benefit individuals email: s.m.merkur@lse.ac.uk
Philipa Mladovsky: +44 (0)20 7955 7298
when used appropriately, Holland cautions us not to
forget that they are only of use when accepted treatments ASSISTANT EDITORS:
Azusa Sato +44 (0)20 7955 6476
for the disease in question are available. Moreover, they email: a.Sato@lse.ac.uk
M
carry well documented risks of side effects, including Lucia Kossarova +44 (0)20 7107 5306
increasing anxiety, overtreatment and overdiagnosis. email: l.Kossarova@lse.ac.uk
Investment in more upstream measures to tackle the EDITORIAL BOARD:

Reinhard Busse, Josep Figueras, Walter Holland,
causes of poor health and health inequalities, he suggests, Julian Le Grand, Martin McKee, Elias Mossialos
may often be a more prudent course of action. SENIOR EDITORIAL ADVISER:
Paul Belcher: +44 (0)7970 098 940
E
We are also particularly delighted to feature in email: pbelcher@euhealth.org
Eurohealth an article from the new World Health DESIGN EDITOR:

Sarah Moncrieff: +44 (0)20 7834 3444
Organization Regional Director for Europe, Zsuzsanna email: westminster.european@btinternet.com
Jakab, who sets out her vision of the way forward for the SUBSCRIPTIONS MANAGER
WHO Regional Office. A number of different measures Champa Heidbrink: +44 (0)20 7955 6840
highlighted include a Strategic Action Review on email: eurohealth@lse.ac.uk
N
addressing the social determinants of health and related
Advisory Board
inequities, in order to inform the European Health
Tit Albreht; Anders Anell; Rita Baeten; Johan Calltorp; Antonio
Strategy and build on the work of Commission on the Correia de Campos; Mia Defever; Isabelle Durand-Zaleski;
Social Determinants of Health. Specific challenges to be Nick Fahy; Giovanni Fattore; Armin Fidler; Unto Häkkinen;
Maria Höfmarcher; David Hunter; Egon Jonsson; Meri
met include strengthening the role of the Regional Koivusalo; Allan Krasnik; John Lavis; Kevin McCarthy; Nata
Committee, as well as the need to further develop strong Menabde; Bernard Merkel; Willy Palm; Govin Permanand; Josef
T
partnerships and joint actions with stakeholders in Probst; Richard Saltman; Jonas Schreyögg; Igor Sheiman; Aris
Sissouras; Hans Stein; Ken Thorpe; Miriam Wiley
Europe and beyond who have health mandates or are
engaged in actions that have health consequences. Article Submission Guidelines
see: www2.lse.ac.uk/LSEHealthAndSocialCare/LSEHealth/
In a packed issue other contributions include our documents/Guidelinestowritinganarticleforeurohealth.aspx
occasional debate series, this time focusing on issues Published by LSE Health and the European Observatory on
around regulation to help minimise bias in respect of the Health Systems and Policies, with the financial support of
evaluation of new drugs. We also feature two articles Merck & Co and the European Observatory on Health Systems
and Policies.
looking at policy implementation: one on mainstreaming
Eurohealth is a quarterly publication that provides a forum for
public health policy at a European level, the other on the researchers, experts and policymakers to express their views on
development of policy for older people in Wales. health policy issues and so contribute to a constructive debate
on health policy in Europe.
The views expressed in Eurohealth are those of the authors
David McDaid Editor alone and not necessarily those of LSE Health, Merck & Co. or
Sherry Merkur Deputy Editor the European Observatory on Health Systems and Policies.
Philipa Mladovsky Deputy Editor The European Observatory on Health Systems and Policies is a
Lucia Kossarova Assistant Editor partnership between the World Health Organization Regional
Office for Europe, the Governments of Belgium, Finland,
Azusa Sato Assistant Editor Ireland, the Netherlands, Norway, Slovenia, Spain, Sweden and
the Veneto Region of Italy, the European Commission, the
European Investment Bank, the World Bank, UNCAM (French
National Union of Health Insurance Funds), the London
School of Economics and Political Science, and the London
School of Hygiene & Tropical Medicine.
© LSE Health 2010. No part of this publication may be copied,

reproduced, stored in a retrieval system or transmitted in any form
without prior permission from LSE Health.
Design and Production: Westminster European

Printing: Optichrome Ltd
ISSN 1356-1030
Contents Eurohealth
Volume 15 Number 4
Building a healthier Europe Vittorio Bertele’ is Head, Regulatory

Policies Lab, Mario Negri Institute for
1 Building a healthier, safer, fairer and greener Europe: my vision for the WHO Pharmacological Research, Milan, Italy.
Regional Office for Europe
Zsuzsanna Jakab Frank DeFelice is Director, Health
Technology Assessment Policy, Europe
and Canada, Merck Sharp and Dohme
Debate: comparative clinical effectiveness
Europe, Inc, Brussels, Belgium.
4 Comparative clinical effectiveness
Silvio Garattini is Director, Regulatory
Silvio Garattini and Vittorio Bertele’
Policies Lab, Mario Negri Institute for
7 Drug development: a complex and risky but potentially rewarding Pharmacological Research, Milan, Italy.
collaborative process
Walter Holland is Emeritus Professor of
Lukas Pfister
Public Health Medicine and Visiting
10 Reponse to Pfister Professor, LSE Health, London School
Silvio Garattini and Vittorio Bertele’ of Economics and Political Science, UK.
10 Patient health improvement: moving to what is adequate and feasible in Zsuzsanna Jakab is World Health
assessment of innovative medicines Organization Regional Director for
Lukas Pfister and Frank DeFelice Europe, Copenhagen, Denmark.
Martin Knapp is Professor of Social

Snapshots Policy and Director of the NIHR School
12 Social Care: a new initiative in England to fill evidence gaps for Social Care Research, London
Martin Knapp and Angela Mehta School of Economics and Political Sci-
ence, UK.
14 Child and adolescent mental health in Europe. Research on best practice
Dainius Puras and Egle Sumskiene Maria Lluch is reading for a PhD, LSE
Health, London School of Economics
and Political Science, UK.
Public health perspectives
Angela Mehta is Finances and
16 Periodic Health Examination – A brief history and critical assessment Communications Administrator, NIHR
Walter Holland School of Social Care Research,
21 The EU School Fruit Scheme: integrating public health into mainstream policy London School of Economics and
Felix Mittermayer and Robert Pederson Political Science, UK.
23 Policy development and implementation: The National Service Framework for Felix Mittermayer is Policy Analyst, DG
Older People in Wales SANCO/02, European Commission.
Gareth Morgan Gareth Morgan is Project Manager,
National Service Framework for Older
Health policy developments People, Llanelli, Wales.
26 Are regulations of community pharmacies in Europe questioning our Robert Pederson manages the
pro-competitive policies? European Agriculture and Health
Maria Lluch Consortium, Brussels, Belgium.
28 Hospital privatisation in Poland Lukas Pfister is Executive Director

Peggy Watson Public Policy, Europe and Canada,
Merck Sharp and Dohme Europe, Inc,
Brussels, Belgium.
Evidence-informed decision making
Dainius Puras is Associate Professor,
32 “Bandolier” Investigating over-the-counter oral analgesics
Institute of Institutional Relations and
37 “Mythbuster” Whole-body screening is an effective way to detect hidden cancers Political Sciences, Vilnius University,
Lithuania.
Egle Sumskiene is based at the Social

Monitor Work Department, Vilnius University,
39 Publications Lithuania.
40 Web Watch Peggy Watson is at the Homerton

College, Department of Sociology
41 News from around Europe
PPSIS, University of Cambridge, UK.
BUILDING A HEALTHIER EUROPE
Building a healthier, safer,

fairer and greener Europe:
My vision for the WHO Regional Office
for Europe
Zsuzsanna Jakab
transition website. The aim of this process peoples in our Region and beyond, under-
has been to stimulate much needed public standing and drawing inspiration from
health discussion, debate and exchange on WHO’s Constitution and its definition of
Europe’s public health environment is key challenges and, most importantly, to health as “a state of complete physical,
rapidly changing. The avoidable and reme- initiate a broadly inclusive process that mental and social well-being and not
diable but persistent health divide in the provides an opportunity for Europe’s merely the absence of disease or infirmity.”
European Region, growing and unfair public health community to actively I see the WHO Regional Office for
inequities in health both within and engage in and shape plans and efforts to Europe as an organisation that:
between countries in the Region, in con- adapt the Regional Office to our changing
– is an effective champion of public health
junction with our changing demographic European environment.
issues and opportunities;
and social landscape are of greatest
Through this informal consultation
concern. These challenges combined with – seriously addresses inequalities and
process, I elaborated a vision for the
pandemic (H1N1) 2009 influenza, the social determinants of health, appealing
Regional Office and posed a series of ques-
growing epidemic of non-communicable to and engaging with a wide range of
tions related to leadership, governance,
diseases (NCD), continuing financial crises sectors and stakeholders at all levels;
partnership, the Regional Office as a net-
and the health impact of climate change
worked organisation and priority actions – continuously strengthens the depth and
demand new ways of advocating, man-
that could be taken to make this vision a quality of work in and with Member
aging and responding for public health at
reality. As I now formally assume my role States through effective policy dialogue
all levels in our globalised world.
as Regional Director for Europe, I will and cooperative action programmes;
I believe that the WHO Regional Office continue this dialogue as part of WHO’s
– ensures its relevance to all Member
for Europe has a key role to play in formal consultation process which will
States and their current and changing
addressing these challenges, as both a inform and shape a ‘Way Forward’
health needs;
proactive leader and a solid partner when strategy that will be presented and dis-
joint actions are needed. Importantly, we cussed in the Standing Committee of the – unites and integrates the Region, acting
need to strengthen our ability to adapt Regional Committee and then in the as a bridge between the different parts
effectively and efficiently to these rapidly Regional Committee in Moscow in Sep- of the Region and promoting the prin-
changing environments and take full tember 2010. I am pleased to now share ciple of solidarity;
advantage of the collective wisdom, expe- this vision and some early thoughts on
– is there for its Member States whenever
rience and know-how of our vast and ways to get there with the readers of
and wherever it is needed, especially in
diverse Region – not only for the Eurohealth.
times of outbreaks or disaster;
improved health of Europe but also for
Europe’s contribution to global health. Vision statement – effectively communicates information
I see the WHO Regional Office for and engages its wide and extended net-
To this end, shortly after being nominated
Europe as a strong, evidence-based centre works to advocate for necessary action;
by the WHO Regional Committee for
of public health excellence that earns the
Europe in September 2009, I launched an – anticipates and analyses changes,
respect and support of Member States and
informal consultation process with opportunities and developments with a
other players for our leadership in health
Europe’s health community, including a potential impact on health and helps
policy and public health. I see the Regional
Member States to respond accordingly;
Office as an organisation whose high–
Zsuzsanna Jakab is World Health Organ- calibre, motivated staff take coordinated – serves as effective secretariat to the
ization Regional Director for Europe, action with partners to ensure attainment Regional Committee and in collabo-
Copenhagen, Denmark. of the highest possible level of health by all ration with Member States turns policy
1 Eurohealth Vol 15 No 4
decisions and recommendations into – putting health at the centre of devel- Partnerships
action; opment as a key consideration in all Over the past decade, Europe has become
sectoral policies at all levels of Gov- an increasingly complex health envi-
– innovates and inspires through its tech-
ernment; and ronment, with many new players and
nical and policy work and links with
challenges. This changing environment has
research communities; – engaging a wider (or broad) range of
significant implications for the role of the
stakeholders.
– works in close partnership with others, Regional Office. It is critical for public
including: Member States and their One of my first decisions after taking health in Europe and beyond that WHO
institutions, WHO Head Quarters and Office in the beginning of February has develop strong partnerships and joint
other regions, United Nations and been to commission, under the chair- actions with partners who have health
other international agencies, European manship of Professor Sir Michael Marmot, mandates or are engaged in actions that
Union institutions, the European public a Strategic Action Review for addressing have health consequences. These partner-
health advocacy and research com- social determinants of health and related ships must find ways to ensure that the
munity, non governmental organis- inequities in the WHO European Region. added value of each partner is maximally
ations (NGOs), and the private sector; The Review will inform the European expressed. By clarifying roles and respon-
Health Strategy and will build on the sibilities, it should be possible to ensure a
– is part of, and actively supports, global
findings and recommendations of the more coordinated approach and avoid
developments within WHO, under the
global Commission on the Social Determi- duplication and parallel actions.
leadership of the DG, and also collabo-
rates closely with the other WHO nants of Health, the Review of Inequalities
The health mandate of the EU has grown
Regions; and in England (the Marmot Review), and
and will continue to grow. The mem-
gather new evidence which reflects the spe- bership and geographical basis of the EU
– promotes a healthy, green and sup- cific realities of all parts of our European has also grown and is likely to continue to
portive working environment for its Region. Importantly, this review will grow. This provides a unique opportunity
staff. translate its findings into policy proposals for new strategic partnerships between
and practical guidance for capacity WHO and the EU. Other important
Leadership building and implementation. partners include NGOs, the Organisation
WHO’s constitution provides the moral,
for Economic Cooperation and Devel-
inspirational and technical fundamentals Governance opment (OECD), UN Agencies, the
for leadership in health policy and public The WHO Regional Committee (RC) Global Fund and others.
health. However, to ensure relevance and includes Ministers of Health from all 53
continue to earn and deserve this lead- countries in the Region, as well as repre- The Regional Office as a networked
ership, there is a need for the Office to sentatives of other UN agencies, the EU organisation
actively and meticulously address all the and NGOs having official relations with My vision is of ‘One WHO’ in Europe,
activities listed in the vision above. I see WHO. The RC formulates policies gov- with all its 35 country offices and centres
our leadership as facilitative rather than erning matters of an exclusively regional fully integrated as part of one strong
prescriptive. Based upon consultative character, and suggests and approves the network. I see the Regional Office in
inputs to date, there appears to be strong calling of Ministerial conferences and such Copenhagen as providing all strategic core
support for the Office to catalyse and additional work or investigation in health functions related to policy, strategy and
coordinate the renewal of a common, matters as in the opinion of the Regional programme development and building on
coherent and comprehensive value-based Committee would promote the objective the work of the centres that produce evi-
European Health Policy which specifically of the Organization within the Region. dence and support implementation and
addresses current health challenges. Such a The RC is a unique and important country offices which promote these evi-
policy would be at the core of our ‘Way platform for policy dialogue and decisions dence–based approaches and adapt them to
Forward’ strategy and would provide a that shape the work of WHO and public their national contexts.
framework and roadmap for Member health more broadly in the Region. I
States and other partners for: believe there is a need to strengthen the RC The European Region is diverse, with its
and its Executive Board, the Standing 53 countries in different stages of devel-
– addressing health inequities and the
Committee of the Regional Committee opment. This is its beauty, strength and
social determinants of health in the
(SCRC), and I am seeking input on ways challenge. WHO should build on Europe’s
European Region;
to make the RC and SCRC more attractive strengths and actively engage with the vast
– dealing in a systematic and targeted way wealth of institutional and expert
and effective for our Member States, as
with present and emerging public knowledge and experience in Member
well as other partners and relevant sectors.
health challenges and priorities; States. At the same time, the Regional
Governance – international health Office can play an important bridging role
– addressing the impact of major devel-
and act to ensure international collabo-
opments that drive societies on health, As shown in the recent Climate Change
ration, as well as encourage and promote
as well as the contribution of health to negotiations in Copenhagen (COP-15),
bi-lateral collaboration and cooperation
these developments: for example, eco- Europe has an important role to play in
within the Region.
nomic and fiscal policies, sustainable global health governance and global health
energy, environment and climate diplomacy to support global develop- I believe that evidence-based technical pro-
change, changes in the demographic and ments. At the same time, the impact of grammes have been and should be the
social landscape of the European globalisation on Europe needs to be backbone of the Organization. They
Region, science and technology, etc; explored further. support development work at European
Eurohealth Vol 15 No 4 2
level, reflecting the priorities, specificity Action priorities for the Office must public health issues. Governments must be
and diversity of the European Region, as include: supported in their handling of complex
well as at country level, adapting interven- public health issues by providing data, evi-
Non-communicable diseases (NCDs),
tions to match the specific needs and dence, policy options and transfer of good
which now represent 80 % of the disease
resources of each Member State. practice. Innovative communication and
burden in the Region. We need an inte-
information tools should be explored and
We will be looking at whether technical grated action plan which addresses all
used more systematically to reach WHO’s
programmes should be focused on selected relevant social and health determinants, as
diverse clients such as decision makers,
priority topics or ensure coverage of a well as the health promotion and disease
professionals and the public, including vul-
wide range of health expertise. We will prevention issues, and strong political
nerable populations and young people.
look at how EURO can best catalyse dia- commitment on alcohol, obesity, physical
EURO must make the best use of available
logue and cooperation between Member activity, smoking and environment from
information and communication tech-
States and link to, engage and utilise the the Regional Committee.
nology.
vast health knowledge and experience of
Communicable diseases (CDs), where
Member States. In this article I have shared with you my
detection of and response to new threats,
vision for the WHO Regional Office for
Our Country offices are crucial in the prevention and control of the old ones
Europe and some of the issues we are grap-
WHO architecture. While the offices in (such as HIV, Tuberculosis, Vaccine Pre-
pling with to make it better positioned and
countries with substantial need for ventable Diseases (VPDs), malaria); special
capable of supporting the 53 countries of
country-specific technical cooperation emphasis on Anti-microbial Resistance
the European Region. These are indeed
programmes have a clear cut and straight- (AMR) and Health Care Acquired Infec-
landmark times for health, but I know that
forward role, the role of the country tions (HCAIs); and assisting Member
together with Member States, WHO can
offices in other Member States (for States in International Health Regulation
craft a strategy and take collective action
example, those that joined the EU in 2004 (IHR) implementation and capacity
that can affect and improve Europe’s
and beyond) may need to be re-examined building will be crucial.
health. Together we can help build a
to find new ways of working. Country
Environment and health, where we need healthier, safer, fairer and greener reality
offices must be useful in delivering the
to ensure implementation of the commit- across the WHO European Region and
WHO agenda to the Member States they
ments of past ministerial conferences and beyond.
serve. Their structures and functions
identify new strategic priorities for the
should be adapted to context-specific
years to come.
needs, expectations and opportunities.
Moreover, WHO has to increase its rele- Strengthening health systems, where we
vance to the EU countries. This requires bring added value to the Member States
better understanding of needs, resources and support the prevention aspects of New project on health
and priorities and identifying issues for health care systems, as well as the strength- services research priority
which WHO support can add value. ening of public health functions. The
further development of primary health setting
We will review whether EURO should
care with appropriate emphasis on pre-
have a country presence in all countries, The European Observatory on
vention and health promotion is a must.
whether sub-regional arrangements should Health Systems and Policies is
Continued help to Member States to
be considered and if WHO country offices
respond to the financial crisis and sup- participating in Health Services
could be joint offices with other partners
porting ministries of health to argue Research (HSR) Europe, a Support
and/or international agencies.
effectively for the macroeconomic impor- Action project in the 7th Framework
Topic-focused, policy, settings-based, tance of health systems is also important. Programme of DG Research.
NGO/civil society, public health and
health professional association networks Training and capacity building This project is aimed to identify,
have been critical in advocating public The Regional Office, supported by collab- evaluate and improve the
health messages, promoting partnerships, orating centres and network experts, is contribution of HSR to the health
change and innovation. We will be looking involved in a lot of training and capacity policy process both at the national
at ways to renew, support and strengthen development across the Region. We are and the EU level.
our networks. looking to better define the Regional
Office’s role in training and capacity One of the major activities is the
Action priorities building and how it can best take organisation of a working confer-
While programme prioritisation has advantage of the vast expertise and expe- ence, on 8–9 April 2010, where the
always been a balancing act between rience in this domain available in the HSR community and decision-
planning and the need to respond to Region. makers are meeting to set an
emergent public health crises and other agenda for European HSR and to
externalities, I believe that the Regional Communications and information system
help strengthen the research-policy
priorities of the Office, under the guidance development
infrastructure Europe wide.
of the RC, should reflect the main disease EURO should be a strong and clear voice
burden of the Region and its determinants, for public health, supporting Member
For more information see:
with the aim of improving the health status States in their actions, and should be heard
www.healthservicesresearch.eu
of the European population. consistently in the global arena on major
DEBATE: COMPARATIVE CLINICAL EFFECTIVENESS
Debate
Comparative clinical effectiveness
Summary: Comparative studies can be done but bias may make them unreliable or even
impracticable. This paper discusses three possible areas of bias. The first regards the methodological
approach: many methodological options may affect the internal and external validity of a compari-
son. The second regards the study hypothesis, which sometimes is not relevant for patients and over-
looks their needs. The third area is the public domain of drug policy. Often products whose absolute
and relative clinical value is uncertain are allowed onto the market on the basis of data produced
by the manufacturers themselves. Political and regulatory authorities should stimulate industrial
research to comply with patients’ and national health services’ needs and could contemplate fund-
ing independent research addressing important questions that do not attract private investment.
Key words: Drug regulation, independent clinical research, controlled clinical trials, active control,
non-inferiority trials.
Clinical effectiveness includes the concept resolving individual heterogeneity into that of non-steroidal anti-inflammatory
of the benefit-to-risk ratio of a given inter- population homogeneity; and statistics, to drugs when compared with diclofenac, but
vention, considered in its real context adequately power the study and interpret greater when naproxen was the com-
where, besides its actual effect, subjective its results as to avoid overlooking any parator.1 The asserted superiority of
and environmental factors such as tolera- effect due to the test treatment (false neg- mycophenolate mofetil over azathioprine2
bility, compliance and cost are all influential. ative) or unduly attributing it to the effect was not confirmed when concomitant
of chance (false positive). treatment with cyclosporin microemulsion
Clinical effectiveness is always assessed by
achieved better therapeutic levels than the
comparison. Sometimes it may appear self- Even so, there are several biases that may
evident by historical comparisons: the old formulation.3
make comparative studies unreliable or
introduction of antibiotics, vaccinations, even impracticable. These come under at The claimed superiority of atypical or
coronary care units, histamine2 receptors least three headings which will be second-generation antipsychotic drugs
and proton pomp inhibitors clearly addressed here in increasing order of over older drugs in this class no longer
reduced mortality or disability, or the need importance in terms of responsibility for holds true in the light of a meta-analysis of
for radical surgery. limiting knowledge about drugs, their 150 randomised trials.4 This analysis found
Other interventions, more often pharma- optimal use, and their place in therapy in that as a group the second-generation
cological treatments, involve uncertainty relation to other treatments. antipsychotics were no more effective, did
and their effectiveness must be carefully not improve specific symptoms, and had
assessed – this is usually done in ran- Methodological biases: the choice of no clearly different side-effect profiles
domised controlled trials. With time these comparators from the first-generation drugs. They were
clinical research tools have acquired The first area of bias lies in the method- also less cost-effective. Therefore the
various means aimed at avoiding bias in ological approach: choice of the ‘atypical’ antipsychotics are now regarded
planning and conducting the studies and in population on the basis of inclusion and as an ‘invention only’, manipulated by the
interpreting the results. These include the exclusion criteria, which all too often drug industry for marketing purposes.5
adoption of a parallel control group taking overlook the needs and interests of
The clinical development of atypical
placebo or, whenever possible, an active children, women and older people; choice
antipsychotics is affected by several biases,
comparator; randomisation, which means and dosage of the comparator; choice of
all favouring second-generation drugs.
that chance distributes subjective charac- the data analysis strategy – intention-to-
These include comparing the second-gen-
teristics into comparable groups thus treat or drug efficacy criteria. There are
eration antipsychotic with a high-potency
many other methodological options that
first-generation one, likely to involve a
can affect the internal and external validity
Silvio Garattini is Director and Vittorio high rate of extrapyramidal side effects: of
of comparison. In this article the choice of
Bertele’ Head of the Regulatory Policies the 150 trials in the meta-analysis, 95 com-
comparator and its dose are important.
Lab, Mario Negri Institute for pared the second-generation antipsychotic
Pharmacological Research, Milan. The cardiotoxic effect of a cycloxygenase- with haloperidol. Comparison with a
Email: sgarattini@marionegri.it 2 inhibitor, rofecoxib, appeared similar to medium-potency first-generation anti-
psychotic was avoided, because these are was not evenly distributed among groups avoided about thirty (at least ten) strokes
likely to be just as effective as the second- at risk: patients with peripheral vascular every 1,000 patients treated, the non-infe-
generation drug, and less likely than disease benefited, those with coronary or riority hypothesis of this study considered
haloperidol to induce Parkinsonism. cerebrovascular disease did not. The it acceptable if aspirin plus extended-
alleged advantage also reflected the release dipyridamole (ASA–ERDP)
Sometimes industry-sponsored studies
selected primary outcome measure: statis- preserved at least half the effect of clopi-
select comparators that are not the best
tical significance disappeared in secondary dogrel. This allows at least five more
available treatments and endpoints that
combined endpoints, particularly strokes (actually 94–95 instead of the 88
magnify their deficiencies, thus facilitating
including major amputation, the most per 1,000 patients reported with clopi-
the better outcome of the experimental
obvious outcome measure for peripheral dogrel, according to the non-inferiority
drug. The ALLHAT study,6 which com-
artery disease. The CURE trial addressed margin set at the odds ratio of 1.075),
pared chlorthalidone, doxazosin, lisinopril,
the main question for patients and national meaning 50 more strokes in the 10,000
and amlodipine for first-line anti-
health services.13 It showed that adding patients randomised to ASA–ERDP. This
hypertensive therapy, showed that low-
clopidogrel to aspirin had an acceptable confirms that a non-inferiority hypothesis
dose diuretics were superior in preventing
safety profile in patients with acute does not address the interests of patients
cardiovascular events. Subsequent
coronary syndromes and was more who would hardly have agreed to partic-
industry- sponsored trials nevertheless
effective than aspirin alone. ipate if they had been aware of this
adopted atenolol as the comparator even
prospect.15 Moreover, though the clinical
though beta-blockers are known to The questions that are important for
outcomes in the two treatment groups
provide a mortality benefit in patients with patients and public health services are
were super imposable, the trial could not
coronary heart disease (atenolol being the those that also consider the feasibility and
prove the non-inferiority of the test
least effective7) but not to prevent affordability of experimental interventions
treatment. Failure to prove non-inferiority
coronary heart disease in patients with and test their comparative cost-
of a treatment basically as effective as the
high blood pressure.8 Moreover, as Psaty effectiveness where possible. The trials
standard shows that non-inferiority trials
and colleagues noted,8 since calcium with clopidrogrel should have taken into
may not even meet their obvious com-
channel blockers are associated with an consideration the fact that that aspirin was
mercial aims of reviving an old drug,
increased risk of heart failure,6 curiously the best known, most widely used and
providing an extended indication and an
enough, heart failure was excluded from least expensive anti-platelet drug.
updated price, while the newer clopidogrel
the composite outcome measure in trials
Sometimes the hypothesis, though inspired was losing its patent protection.
where these were the test drugs,9,10 but
by marketing aims, is of public health
was included when a calcium channel Another approach that does not fully meet
interest too. However, the methodological
blocker, amlodipine, was the comparator.11 patients’ and National Health Service
approach mostly addresses industrial
(NHS) interests is known as the ‘add-on’.
interests. For instance, non-inferiority
Strategic biases: irrelevant questions for Sometimes a new drug is added to the
trials are only designed to prove that a new
patients current treatment in the experimental arm
drug is no worse than a comparator
The second area of bias is the study and compared with placebo given on top
already on the market. From the industry’s
hypothesis, which should address clinical of the current treatment in the control
point of view these studies are preferable
questions relevant for patients, meaning group. Comparing one treatment with two
since it is easier to show non-inferiority
looking for answers to unmet needs. seems an uneven match, since it may well
than superiority and less risky too: failure
Testing the superiority of a new product be easier for the new drug combined with
to prove superiority may damage a
over placebo when active comparators are the standard treatment to perform better
product and a company’s image whereas
available, or its non-inferiority to active than the latter alone. Moreover, this
proof of non-inferiority ensures a place on
drugs, aims at satisfying marketing pur- approach does not provide adequate infor-
the market. However, these studies only
poses, not patients’ needs. mation on how the test drug added on top
produce ‘me-too’ drugs with no identi-
of ongoing therapies fares in comparison
The MATCH study randomised patients fiable added value and no real place in
with other treatments. This would only be
with a recent transient ischemic attack therapy.
possible if two active treatments were
(TIA) or ischemic stroke to clopidogrel
It is also worth recalling that non-inferi- used, as either an alternative or an add-on
plus aspirin compared with clopidogrel
ority is defined as a kind of similarity to current unsatisfactory therapies. In add-
plus placebo. The study showed that any
within a limit which includes a degree of on studies placebo should only be allowed
benefit of the combination over clopi-
inferiority that is believed to be tolerable. if no combinations of effective drugs can
dogrel alone in reducing the risk of
A test drug that has been proved non- be proposed for comparison.16
ischemic events after a TIA or stroke was
inferior may actually be less effective or
small. Testing aspirin as an add-on to The alleged reason for selecting the add-on
less safe than the comparator, but not so
clopidogrel took it for granted that the approach is the need to test remedies for
much as to be recognised as such. Non-
latter was the first-choice treatment in poor responders to current treatments.
inferiority trials allow an excess of adverse
these patients. This assumption was poorly However, if the current treatment is defi-
events associated with the test treatment
evidence-based. It relied on the results of nitely not effective, it should not be
and do not consider them enough to signal
the CAPRIE study12 which had shown continued in either group, as it would be
a difference from the comparator.
marginal statistical superiority of clopi- useless and therefore unethical. If it is
dogrel over aspirin: five cardiovascular The non-inferiority approach can produce partially effective, adding placebo in one
events avoided yearly every 1,000 patients paradoxical situations like the PRoFESS arm but an active drug in the other would
treated. Besides being small, the benefit Study.14 Assuming that clopidogrel be unethical too.
Regulatory biases: no added value to pharmacovigilance. The results should Recent Trials in Hypertension. Compelling
required help improve NHS pharmaceutical policy Science or Commercial Speech? Journal of
The third area is the public domain of drug and reinforce decisions on drug reim- the American Medical Association
policy. Pharmaceutical legislation requires bursement. 2006;295:1704–6.
companies seeking marketing authori- A call for proposals indicates the topics of 9. Pepine CJ et al. A calcium antagonist vs.
sation for new products only to provide a non-calcium antagonist hypertension
interest each year. Letters of intent are
data demonstrating their good manufac- treatment strategy for patients with coro-
screened by AIFA to identify a list of
turing quality, lack of toxicity, and clinical nary artery disease: INVEST: a randomised
projects then evaluated by international
efficacy.17 These product features are controlled trial. Journal of the American
study sections. The third call was con-
meant to stand on their own, with no need Medical Association 2003;290:2805–16.
cluded in 2008. Thus far 151 projects have
for comparison with drugs already on the been approved with a budget of €78 10. Dahlof B et al. Prevention of cardiovas-
market. These rules allow products onto million. This is a significant amount of cular events with an antihypertensive regi-
the market whose absolute and respective money because under this law pharmaceu- men of amlodipine adding perindopril as
clinical value is uncertain.18,19 They also tical products, insurance and fees for the
required vs. atenolol adding bendroflume-
foster overuse of trials against placebo. thiazide as required in the ASCOT-BPLA:
ethical committees are all paid by the
a multicentre randomised controlled trial.
Even when new drugs are compared with NHS. The Italian initiative may offer a
Lancet 2005;366:895–906.
existing treatments, trials often seek to model that can be extended to other coun-
tries or the European Union as a whole. If 11. Julius S et al. Outcomes in hypertensive
show non-inferiority rather than superi-
this happens the number of independent patients at high cardiovascular risk treated
ority. This implies that newly approved
clinical trials may build up to become a sig- with regimens based on valsartan or
drugs might be less active or safe than amlodipine: the VALUE randomised trial.
those in current clinical use.15 In addition, nificant counterpart to industrially
Lancet 2004;363:2022–31.
efficacy is often measured on the basis of supported studies.
12. CAPRIE Steering Committee. A
soft clinical endpoints or surrogate ACKNOWLEDGMENTS: We are grateful to randomised, blinded trial of Clopidogrel
markers of efficacy.19 Finally, the docu- Judith Baggott for editorial revision. versus Aspirin in Patients at Risk of
mentation on which the marketing
Ischemic Events (CAPRIE). Lancet
authorisation application is judged is 1996;348:1329–39.
mainly produced by the manufacturers, REFERENCES
which not only select the clinical area of 13. Yusuf S et al. Effects of clopidogrel in
1. Psaty BM, Weiss NS. NSAID trials and addition to aspirin in patients with acute
intervention, choosing the least risky and the choice of comparators–questions of coronary syndromes without ST-segment
most profitable, but also the kind of trial, public health importance. New England elevation. New England Journal of
aims and approach, the most suitable Journal of Medicine 2007;356:328–30. Medicine 2001;345:494–502.
investigators, and whether and how to
2. Fulton B, Markham A. Mycophenolate 14. Sacco RL et al. 1. Aspirin and ex-
analyse and publish the results.
mofetil. A review of its pharmacodynamic tended-release dipyridamole versus clopi-
Health authorities need to stimulate and pharmacokinetic properties and dogrel for recurrent stroke. New England
industry research to comply with patients’ clinical efficacy in renal transplantation. Journal of Medicine 2008;359:1238–51.
and NHS services, besides their marketing Drugs 1996;51:278–98.
15. Garattini S, Bertele’ V. Non-inferiority
goals, however legitimate these may be. 3. Remuzzi G et al. Mycophenolate mofetil trials are unethical because they disregard
EU legislation should require the docu- versus azathioprine for prevention of acute patients’ interests. Lancet
mentation accompanying marketing rejection in renal transplantation (MYSS): a 2007;370:1875–77.
authorisation applications to include randomised trial. Lancet 2004;364:503–12.
16. Ottolenghi L, Bertele’ V, Garattini S.
clinical trials designed and conducted by 4. Leucht S et al. Second-generation versus Limits of add-on trials: antirheumatic
independent institutions and cooperative first-generation antipsychotic drugs for drugs. European Journal of Clinical
groups. In addition public institutions schizophrenia: a meta-analysis. Lancet Pharmacology 2009;65:33–41.
could fund independent research 2009;373:31–41.
addressing clinical questions that are not of 17. Regulation (EC) No. 726/2004,
5. Tyrer P, Kendall T. The spurious advance European Parliament and Council of 31
interest to the pharmaceutical industry of antipsychotic drug therapy. Lancet March 2004. Community procedures for
which do not attract investment. 2009;373:4–5. the authorisation and supervision of me-
In Europe there are no real incentives for 6. ALLHAT Group. Major outcomes in dicinal products for human and veterinary
independent clinical research, albeit with a high-risk hypertensive patients randomised use and establishing a European Medicines
few exceptions, as in Italy. In 2004 the to angiotensin converting enzyme inhibitor Agency. Official Journal of the European
Italian Parliament passed a law requiring or calcium-channel blocker vs. diuretic: the Union 2004;L136/(30 April):1–33).
pharmaceutical companies to pay a fee Antihypertensive and Lipid-Lowering 18. Joppi R, Bertele’ V, Garattini S.
equivalent to 5% of all their promotional Treatment to Prevent Heart Attack Trial Disappointing biotech. British Medical
expenses, except salaries. This money is to (ALLHAT). Journal of the American Journal 2005;331:895–97.
Medical Association 2002;288:2981–97.
be utilised by the Italian Agency for Drugs 19. Apolone G et al. Ten years of
(AIFA) to support independent clinical 7. Freemantle N et al. Beta-blockade after marketing approvals of anticancer drugs in
research in three main areas: orphan drugs myocardial infarction: systematic review Europe: regulatory policy and guidance
for rare diseases, head-to-head compar- and meta-regression analysis. British documents need to find a balance between
isons of drugs with similar indications and Medical Journal 1999;318:1730–37. different pressures. British Journal of
outcome studies with particular reference 8. Psaty BM, Weiss NS, Furberg CD. Cancer 2005;93:504–9.
Debate:
Drug development: a complex and risky but
potentially rewarding collaborative process
Lukas Pfister
Summary: Clinical research standards evolve in line with new knowledge and experience.
Research and development is focused on current health challenges and is increasingly outcome
and health gain oriented. New regulations ensure transparency, elimination of bias and that
under-served yet complex populations are included in clinical studies while industry is
commensurately rewarded. Clinical studies performed for regulatory approval purposes should
remain the responsibility of the pharmaceutical industry and continue to be grounded in collabora-
tion with clinical investigators and the public authorities. There is no basis for introduction of a
relative effectiveness barrier at the regulatory approval stage. There is no evidence that a tax on
innovator companies will provide an efficient system of funding productive independent studies.
Key Words: Drug regulatory policy; clinical trial standards, approval and monitoring;
clinical trials in complex populations; relative effectiveness.
In this issue of Eurohealth1 in their paper and guidelines for patient management, of its life cycle. It is only the commercial
on comparative clinical effectiveness, developed by independent professional laboratories with their capacity and
Garattini and Bertele’ question the validity consensus teams, provide essential support resource to undertake such high-risk
and aptness of clinical studies performed to physicians in navigating available investment that can take forward the
or sponsored by pharmaceutical com- treatment options for their patients. applied research and development from a
panies. This view is based on promising idea to a successful medicine.
More recently, payers have focused on the
generalisations and selective citing of the
relative effectiveness of medicines in terms The drug development process is generally
literature, while failing to appreciate some
of their comparative value for money. The incremental. The choice of therapeutic area
of the immense challenges facing devel-
European High Level Pharmaceutical is often driven by a company’s prior expe-
opment of new medicines.
Forum provided a working definition of rience in that area, but industry research
Throughout the twentieth century, scien- relative effectiveness as the extent to which activity also focuses on those areas which
tific advances provided for the an intervention does more good than harm are of major interest to health authorities,
development of new medicines both to compared to one or more intervention the medical community and patients alike.
treat conditions which were previously alternatives for achieving the desired Neurodegenerative disorders and cancer
untreatable and to improve disease man- results, when provided under the usual cir- are clear leaders in the pipeline of the
agement. This progress was accompanied cumstances of health care practice.2 The largest pharmaceutical manufacturers.3
by increasingly rigorous standards of last two decades have seen the estab- The sharing of knowledge within the
product efficacy, safety and quality. The lishment of national health technology wider scientific community concerning
innovative pharmaceutical industry was assessment (HTA) agencies, whose task is basic scientific research and new tech-
actively involved in the development, the appraisal of medical therapies and nology means that pharmaceutical research
implementation, and promotion of these interventions for public funding (and in laboratories may be working in parallel on
standards. Similarly, industry has been a some cases pricing) purposes. new chemical entities with similar mecha-
strong supporter of evidence-based med- nisms of action. In the seventies, the
icine (EBM) and has structured Research and development average time between the approval of the
promotional activities in the context of The process of developing drugs from the first-in-class product and the next was
treatment outcomes. Numerous protocols first idea through to regulatory approval is about eight years. This gap decreased to
long, complex, resource-intensive and is less than two years in the late nineties.4 It
full of risk with return on investment is not unusual for first market entrants
Lukas Pfister is Executive Director Public uncertain and often delayed. Uncertainty from a new class of drug to undergo regu-
Policy, Europe and Canada, MSD continues post-approval since pharma- latory approval concurrently. Such robust
(Merck Sharp and Dohme) Europe, Inc, covigilance concerns may result in development activities are good for
Brussels, Belgium. withdrawal of a new medicine at any stage patients since identical substances may
affect patient subgroups differently due to brochure (a compilation of relevant data lation as a whole, the largest group of
genetics, age, co-morbidities, multiple on the product under study), and subject potential beneficiaries, or a special sub-
drug treatment, and even subjective per- recruitment arrangements. Trials may only population first. Studies in populations
sonal preferences. Within one class commence once ethics and regulatory with significant co-morbidities and mul-
(defined by the mechanism of action), and approvals have been secured. Indeed, tiple drug treatment are more complex,
depending on the end-points, certain dif- ethical committees have the power to reject may take longer, have recruitment chal-
ferences in adverse events and efficacy may a clinical trial. A clinical trial may only be lenges and require greater resources. Initial
be expected. undertaken if risks and inconveniences trials in simple populations may allow
have been weighed against the anticipated faster completion of studies and regulatory
In some cases, later entrants in a class were
benefits for the individual trial subjects and approval and earlier availability as a
ultimately preferred to the first-in-class.
future patients. Regulatory agencies treatment option. Later studies may then
Indeed, as long as twenty years ago, half of
understand the complexities and chal- look at special sub-populations to ensure
the drugs on the WHO Essential Drugs
List were compounds introduced subse- lenges associated with comparative studies, that the benefits of treatment may be
quent to the first in a therapeutic class.5 and take these into consideration when accessible to patients who would oth-
While clinical studies in the drug devel- approving treatments. erwise be disadvantaged.
opment period are sufficient for regulatory Since many trials have a multi-national Until recently, medicines used in children
purposes, it is the information arising from scope, applications for approval must be lacked adequate information on efficacy
their everyday use which provides for the submitted in every Member State con- and safety. That unfavourable situation has
build-up of their reputation and this can be cerned. Relevant information about the already changed dramatically. The
seen in the generic companies’ choice of trial must be entered into the European enactment of the Paediatric Regulation in
products for manufacture when the drug database accessible to the Commission and the EU8 has meant that since July 2008 all
patent expires. Application of the term to the competent authorities of Member new applications for marketing authori-
‘me-too’ to medicines which are the result States. Appropriately qualified and trained sation have had to include results of studies
of simultaneous research often greatly inspectors are appointed by competent in a paediatric population conducted
underestimates the enormous challenges authorities to verify compliance with GCP according to an approved Paediatric Inves-
and complexity of the underlying research according to set procedures. tigation Plan unless a waiver or deferral has
conducted and fails to recognise the inten- been obtained. Similarly, since January
sified competition between innovators. The competent authorities also have the
2009, applications for additional indica-
The appearance of more than one product power to require a comparison to be
tions, formulations or routes of
in the same class provides for choice based carried out and to suggest a placebo or a
administration for medicines which are
upon the individual patient’s circum- specific comparator. In Europe, it is more
already approved must also conform to
stances. Choice between innovative common to use a standard existing
this requirement.
products also ensures competition treatment, although the multi-national
between research-based companies and has character of clinical trials means that the Standards for inclusion for older patients
a role in modifying product launch price. comparator may not always be the most are provided by the International Con-
Moreover, the fundamental principles of a commonly used treatment in all partici- ference on Harmonisation of Technical
market-driven economy underscore the pating countries. A review of products Requirements for Registration of Pharma-
inevitability of such simultaneous authorised in the EU between 1999 and ceutical for Human Use (ICH)
appearance of multiple products. 2005 showed that 71% of studies used Guidelines.9 In 2006 a report for the
active standard treatment as comparator European Commission on the adequacy of
Clinical studies and 81% of new medicinal products had the guidance of the European Medicines
Clinical studies are highly regulated and been tested against active standard Agency10 found overall reasonable com-
increasingly so. The provisions of the EU treatment in at least one trial.7 pliance with the ICH guidelines and with
Clinical Trials Directive6 ensure that disease related efficacy guidelines. The
Non-inferiority trials have a role to play as
sponsors and others involved in clinical need for some revision of the guidelines
they satisfy the regulatory requirements
research apply the standards of good resulted in an ICH concept paper in
for safety, efficacy and quality. Moreover,
clinical practice (GCP) rigorously when October 2008 which set out those elements
they leverage upon the long term expe-
designing, conducting, recording and which were essential to ensure that clinical
rience and clinical trial data of comparator
reporting clinical trials. Compliance with trials were relevant to the elderly popu-
products. Real life use of the medicine over
these standards provides for credibility of lation. Additional issues for discussion
the longer term and phase IV studies then
study results. Clinical study protocols prior to trial approval would include the
allow for the evaluation of its place in
which describe the objectives, design, number and age distribution of expected
disease management. Trials to evaluate
methodology, inclusion and exclusion cri- old, particularly very old participants,
superiority are sometimes not practical –
teria, statistical considerations and appropriate characterisation of safety in
they may require sample sizes that are
organisation of a trial, must be submitted this population which could be obtained
impractical – and superiority in one aspect
for approval to independent ethics com- post-marketing, specific elements for eval-
(such as one measure of efficacy) may not
mittees and competent national authorities uation of risks and benefits, including
be the goal; sometimes the goal is to
(usually the Regulatory Agency or Min- concomitant co-morbidities and therapies,
improve the safety profile while main-
istry of Health). This also takes into discussion and justification of specific age
taining efficacy, for example.
account the relevance of the trial related end-points (elderly-relevant out-
hypothesis, its design, the suitability of the Different strategies may be adopted comes), and defining the usefulness of
investigative team, the investigators ranging from studying the target popu- specific pharmacokinetic studies.11
Public policy and medicines tiatives by the state instead of the private stakeholder involvement. The new provi-
Extensive regulation of the manufacture sector have continuously been disap- sions are reflected in training programmes
and licensing of medicinal products is jus- pointed, be it in market economies (where for those in the research community.
tified by the harm that could arise from the governments created the conditions for
The suggestion that industry sponsors and
unregulated access of medicines. The legis- private sector innovation to flourish), or in
investigators manipulate data constitutes a
lators of the European Union have the former state controlled economies of
simplistic generalisation and is grossly
adopted the policy position that marketing Central and Eastern Europe (where vir-
unfair to the thousands of scientists who
authorisations based upon safety, efficacy, tually no innovative products were
devote their lives to the development of
and quality are sufficient to ensure patient developed). Instead, competitive research
new medicines. Indeed, companies and
benefit and safety, without the need for the within the private sector has been a key
industry associations have developed and
introduction of additional barriers to driver for innovators to make enormous
implemented strict ethical codes of
market entry, which would delay patient investments, shouldering the tremendous
conduct which are sometimes more
access to new medicines significantly. risk associated therewith and bearing the
stringent than state regulations.
high development costs, particularly those
Since access to medicines in the public
of phase III clinical studies, the most Efficient use of public funds is essential to
health systems in Europe is largely based
expensive part of research and devel- ensure the maximisation of health gains.
upon reimbursement from public funds,
opment. Stakeholders have a common goal in
the payer interest is safeguarded because
adequate prescribing occurs only when ensuring progress so that disease can be
Public authorities did not themselves
reimbursement authorities decide upon eliminated or limited.
undertake development of drugs in under-
coverage. Increasingly, the effective value served populations such as those with
of a new medicine to the payer is deter- orphan disease, but what they have done is
REFERENCES
mined by HTA. The innovative industry to encourage commercial entities to
supports the concept of HTA, providing it develop orphan drugs by providing incen- 1. Garattini S, Bertele V. Comparative clini-
is performed correctly, used for the right tives including a two year extension of cal effectiveness. Eurohealth
purposes and not limited to drug versus regulatory data protection (i.e. generic 2009;15(4):4–6.
drug comparisons. Furthermore, treatment manufacturers may generate their own 2. Core principles on relative effectiveness.
guidelines and recommendations data but the original innovator company’s High Level Pharmaceutical Forum. Avail-
developed by professional societies play a data cannot be referred to for regulatory able at www.ec.europa.eu/pharmaforum/
leading role in disease management. purposes).12 Incentives were also provided docs/rea_principles_en.pdf
However, there is a significant lag before to encourage paediatric studies through 3. DiMasi JA. The Economics of New Drug
new medicines appear in the guidelines, extension of regulatory data protection Development: Costs, Risks, and Returns.
during which their usefulness compared and Supplementary Protection Certificate Tufts Center for the Study of Drug Devel-
with products available earlier is often term. opment Tufts University. The New Eng-
established from results of phase IV land Drug Metabolism Group Spring
studies. Disincentives against innovative research
Meeting Cambridge, MA, 12 March 2008.
activities such as putting a levy on inno-
The generation of efficacy, safety and Available at www.nedmdg.org/docs/2008/
vator companies (e.g. asking a payment of joseph-dimasi-spring-2008.ppt
quality data is a necessary part of the a portion of profits into a research fund)
development of a proprietary new med- must be strongly cautioned against, as they 4. DiMasi JA, Paquette C. The economics
icine and should be performed by the of follow-on drug development. Trends in
may force companies to fund research of
innovator company as the prospective entry rate and the timing of development.
their competitors. Apart from the risk of
holder of the marketing authorisation. Pharmacoeconomics 2004;22(suppl 2):1–14.
not producing the intended effect, the
Repetition of such studies by another concern of regulating in a discriminatory 5. Wastila L, Elcickas M, Lasagna L. The
party would not be justified for economic manner against one particular sector of the WHO essential drugs list. The significance
and ethical reasons. Nonetheless, gener- economy should not be taken lightly. of me-too and follow-on research. Journal
ation of regulatory data is a collaborative of Clinical Research and Drug
process between research laboratory sci- Conclusion Development 1989;3:105–15.
entists and the clinical investigators and Evaluation of current practices is welcome 6. Directive 2001/20/EC, European
their institutions. This is a transparent since this can draw attention to the need to Parliament and Council of 4 April 2001.
process that is open to ethics committee amend future practices. With hindsight, it Approximation of laws, regulations and
and competent authority review and is easy to say that former trials should have administrative provisions of the Member
subject to “live” inspection throughout the been designed differently. However, States relating to the implementation of
trial. Casting doubt on the credibility of good clinical practice in the conduct of
whenever unrecognised forms of bias are
these data is to cast doubt on the credi- clinical trials on medicinal products for
identified, they are successively eliminated
bility of all parties. Additional human use. Official Journal of the
from new study designs. The current
transparency arises from clinical study reg- European Union 2001; 1 May:L121/34–44.
model of the regulatory approval process
istries with online public access 7. van Luijn JCF, van Loenen AC,
is collaborative rather than adversarial with
(www.clinicaltrials.gov and www.clinical Gribnau FWJ, Leufkens HGM. Choice of
improvement in clinical trial design arrived
studyresults.org) which provide comparator in active control trials of new
at by discussion with the authorities. Iden-
information on ongoing studies as well as drugs. Annals of Pharmacotherapy
tification or emergence of new needs is
on study results. 2008;42(11):1605–12.
accompanied by the enactment of new reg-
Hopes in significant drug development ini- ulations in a process that allows 8. Regulation (EC) No 1901/2006, Euro-
pean Parliament and Council of 12 Decem-

ber 2006. Medicinal products for paediatric
use and amending Regulation (EEC) No
Debate
1768/92, Directive 2001/20/EC, Directive reponse to Pfister
2001/83/EC and Regulation (EC) No
726/2004. Official Journal of the European
Union 2006; 27 December: L378/1–19.
9. ICH Tripartite Guideline. Studies in
Support of Special Populations: Geriatrics. It is impossible to tackle all the arguments entrants are usually preferred to older
Geneva: International Conference on
raised in this limited space. We shall only products not because of their proven better
Harmonisation of Technical Requirements
make a few points. There is no need for efficacy or safety but thanks to more
for Registration of Pharmaceuticals for
industry to manipulate data: it is enough to intense advertising.1 Moreover, off-label
Human Use, 1993. Available at
www.ich.org/LOB/media/MEDIA483.pdf select targets and approaches suited to its use of drugs is repeatedly promoted to
legitimate commercial aims according to boost sales.2 If not even inappropriate indi-
10. European Medicines Agency. Adequacy the current rules. The criteria of intrinsic cations are available, bizarre diseases are
of Guidance on the Elderly Regarding quality, safety and efficacy on which mar- ‘invented’ just to find a market for
Medicinal Products for Human Use.
keting authorisations are based may ensure products with no real place-in-therapy.3
London: EMA, 14 December 2006. Avail-
patients’ benefit and safety, but not neces- All this makes commercial interests prevail
able at www.emea.europa.eu/pdf/human/
sarily their best possible benefit and safety. over those of public health.
opiniongen/49892006eu.pdf
This is because it is legitimate to compare a
11. Final Concept Paper E7(R1): Studies in new product with placebo or with the most
Support of Special Populations: Geriatrics suitable comparator(s) to highlight its REFERENCES
(Revision of the ICH E7 Guideline)
clinical merits, or to look for non-inferi- 1. Day RO, Williams KM. Open-label ex-
Geneva: International Conference on
ority compared to the appropriate tension studies: do they provide meaning-
Harmonisation of Technical Requirements
comparator, and so on. The risk-benefit ful information on the safety of new drugs?
for Registration of Pharmaceuticals for
profiles of newer and available products Drug Safety 2007;30:93–105.
Human Use, 2008. Available at
www.ich.org/LOB/media/MEDIA4930.pdf are deliberately not compared since the
2. Hopkins Tanne J. Pfizer pays record fine
definition of later entrants’ place-infor off-label promotion of four drugs.
12. Regulation (EC) No 141/2000, therapy might limit their place in the
European Parliament and Council of British Medical Journal 2009;339:3657.
market. Evaluation of a drug’s clinical
16 December 1999. Orphan medicinal 3. Moynihan R, Heath I, Henry D. Selling
value cannot be left to post-marketing
products. Official Journal of the European sickness: The pharmaceutical industry and
everyday use; experience outside a con-
Union 2000; 22 January: L18/1–5. disease-mongering. British Medical Journal
trolled setting cannot replace evidence as a
2002;324:886–91.
basis for a new drug’s reputation. Later
Debate
patient health improvement: moving to what is adequate
and feasible in assessment of innovative medicines
Lukas Pfister and Frank DeFelice
Pharmaceutical innovation, in the form of system spending, pharmaceutical expendi- Surely, on the road to the ‘best possible
either a ‘breakthrough medication’ or an tures are among the most measured for benefit’, which Garratini and Bertele’ and
incremental enhancement, has brought value by public payers. The processes for all of us in society aspire to, we can make
improvements to patient health and quality marketing authorisation approval, the improvements to patient health and quality
of life. review of clinical and cost-effectiveness, of life, be it via enhanced clinical impact,
and the consideration of budget impact for improved side-effect profiles, and better
The goal of health care delivery should be
public plan reimbursement, are among the tolerance and dosing?
value for patients, not containing costs.1,2
most rigorous and evidence-based across
Examined in the context of overall health Instead of an ideological simplification of
public health care expenditures. In addition
to thorough pre-authorisation and pre- interests as conveyed by the authors, the
Lukas Pfister is Executive Director Public reimbursement reviews, ongoing patient debate should be focused on how to ensure
Policy and Frank DeFelice Director, impact of medication use is measured via patients have timely access to needed,
Health Technology Assessment Policy, indicators, including surrogate markers appropriate innovative medications. Had
Europe and Canada, MSD (Merck Sharp such as HbA1c for long-term blood HIV/AIDS patients been forced to await
and Dohme) Europe, Inc, Brussels, Bel- glucose control for patients with dia- treatment at the time of introduction of the
gium. Email: frank_defelice@merck.com betes.1,2 promising early AIDS medication pending
SNAPSHOTS
real outcome versus surrogate outcome improve patient health. It is puzzling that Results. Cambridge, MA: Harvard
data, morbidity and mortality rates would one would advocate the reduction of Business School Press, 2006.
have been adversely affected. In other exceptional scientific minds that are 3. Best Brain Consultation: The Data
words, millions of lives were saved as a applying themselves fully to the discovery Divide – Determining the Adequacy and
result of reimbursement decisions based of treatments and that are being financed Feasibility of Data for Funding Decisions.
on a reasonable review of available data, by means other than by taxpayers. The Forum held by the Canadian Institute of
with the understanding that as further data value of pharmaceutical innovation rests Health Services and Policy Research and
became available that amendments could ultimately in providing better health care, the Ontario Ministry of Health and Long-
be made to how products would be reim- better quality of life, and the ability to live Term Care. The University of Toronto,
bursed. This exemplifies a ‘patients-first’ longer for patients.4 Pharmaceutical com- June 2009.
approach. panies and publicly funded bodies have a 4. Griller D. Pharmaceutical Research and
role in fully capturing this value. its Value to Canadians. Montreal: SECOR,
Public payers themselves have charac-
2007
terised the debate in this manner and are
already posing the reasonable question – 5. Reuters Health. UK Plans to Let Some
REFERENCES
what is ‘adequate’ in terms of data and Drugs Bypass Value Watchdog. 14 July
information requirements to ensure due 1. Porter, Michael. Value-based Health 2009.
Care Delivery. Presentation, University of
diligence in the review of medications yet 6. DiMasi JA, Hansen RW, Grabowski
Toronto, 11 June 2009.
is also ‘feasible’ to request of manufac- HG. The price of innovation: new esti-
turers at the front end of the approval 2. Porter M. Redefining Health Care: mates of drug development costs. Journal
process? Posed in this way, one needs to be Creating Value-based Competition on of Health Economics 2003;22(2):151–85.
mindful of the patient impact of delays or
restrictions on novel medicines.
In the past twenty years alone, innovative
medications have helped to reduce hospi- Observatory Venice Summer School 2010
talisation rates dramatically for ulcers,
HIV/AIDS, diabetes, respiratory diseases
and liver diseases among others. In that
same time frame, death rates have also been
EU integration and health systems
reduced dramatically for cardiovascular
San Servolo, Venice, 25–31 July 2010
and HIV/AIDS patients to cite two
examples.4
The European Observatory on Health Systems and Policies is The Summer School is
Instead of establishing new regulatory and happy to announce the Observatory Venice Summer School intended for senior to
reimbursement hurdles, we should be pro- 2010. Jointly organised with the Veneto Region – one of the mid-level policy-makers
viding incentives for innovation that Observatory’s partners – the Summer School will look at the and more junior
expedite access for patients and will allow growing influence of European integration and regulation on professionals who are
health systems, and the practical opportunities and chal- making careers in policy
certain innovative drugs to be fast-tracked
lenges that this creates for patients, professionals and pol- and management at a
by, for example, bypassing customary
icy-makers. It will explore different EU policy fields to identify regional, national or
cost-effectiveness review.5 links with health and assess their impact on health systems. European level.
Leading clinical practice is guided by
health professionals that are swayed most The main aim is to identify key issues where the EU
by persuasive scientific evidence and what creates challenges for national and regional health
systems; share participants’ insights (whether they are
is in the best interests of their patients.
health professionals, policy makers or analysts); and
Marketing has a role and can be effective
build contacts and networks to help respond.
but if it is not based on strong scientific
evidence and on advancing patient health, The course will be organised into three modules:
it will not resonate convincingly with
leading clinical practitioners. ■ The institutional and regulatory framework
We have previously pointed out the ■ Economic integration and health systems’ governance
complex and high risk nature of discov- ■ Supportive EU policies and instruments for health
ering new medicines. The research and systems governance
development costs for one drug have been
In addition to the lectures, an important part of the
estimated to be over $800 million.6 Clearly
programme is dedicated to exchange between participants
funding by both public institutions and and group work. A policy round table will be organised,
private firms has a critical role to play in involving various policy-makers and representatives of European
advancing pharmaceutical research and institutions, such as the WHO Regional Office for Europe
development and finding the next cure, and the European Commission. on Health Systems and Policies
treatment, or vaccine. In an era of difficult
economic circumstances, providing greater
incentive for innovation by the private For more information and an application, see www.observatorysummerschool.org
sector is a particularly productive way to
SNAPSHOTS
Social Care: a new initiative in

England to fill evidence gaps
Martin Knapp and Angela Mehta
Many millions of adults in Europe are individuals or what services can do to meet is coordinated with the best interests and
receiving social care, which can be defined them. the preferences of the individual in mind,
as support for individuals with the activ- while cognisant of resource constraints.
Again, in contrast to health and health
ities of their daily lives, which can range
care, the evidence base upon which
across personal needs, domestic tasks, Research needs
practice and policy decisions are taken in
social activities and friendship. Most of this Clearly social care touches the lives of
social care is rather less well developed.
support is unpaid care from family and many people. It contributes a huge amount
Although hard to substantiate with figures,
friends, but there are also large numbers of to the nation’s well being and health. To
it would generally be recognised that there
community organisations, charities, for- support the development of social care
has not been the same level of investment
profit (private) companies and state bodies practice in Europe, there is a need for
in robust research. Consequently, govern-
delivering ‘organised’ care services. research evidence on what people want,
ments, state agencies, community
how it can be provided, what works and
With the ageing of populations in organisations and others do not have much
what it costs. All of this is needed to
European countries, and indeed with the of a platform of evidence about how to
provide policy makers with the tools to
longer survival into old age of increasing meet needs, improve quality of life, or
develop innovative, cost-effective services.
numbers of people with disabilities and pursue cost-effectiveness.
enduring illnesses (people who, in previous Evidence generated by research has the
generations, would generally not have Challenges potential to contribute substantially to
lived for as long), the future social care It is an enormous task to ensure that meeting these challenges. But that research
challenge facing Europe is clearly support and care are available for people needs to be carefully planned, competently
enormous. who need them, and that the arrangements executed and skilfully communicated to
are what those individuals want. So too is target audiences.
The largest groups of users are older
the task of generating and organising
people, children and adolescents, people
resources so as to achieve the best out- New investment in adult social care
with long-term disabilities or conditions,
comes in an efficient, equitable manner. research in England
and those with sensory impairments.
Another challenge is to dovetail responses The National Institute of Health Research
Depending on the country, other groups
and activities across different sectors – (NIHR)*, located within the Department
might be using social care services. Indeed,
making sure that central, regional and local of Health, spends considerable amounts on
the term ‘social care’ is not universally
government agencies work effectively with health and social care research in England.
applied: other common terms are ‘welfare
the voluntary and community sector, as Established in April 2006 to carry forward
services’, ‘personal social services’, and
well as with for-profit entities. the vision, mission and goals outlined in
‘social services’. Unlike health care, there
the Government’s health research strategy
is less international consensus not only Most importantly, responses must be
for England, Best Research for Best
about terminology, but about what is planned sensitively and appropriately with
Health, the NIHR had a £790 million
included in the sector, and certainly there is families and other unpaid carers. There is
revenue budget with £31 million capital
less awareness among the general popu- also an obvious need to make sure that
funding in 2008/09.1,2 Its vision is to
lation of the social care needs of action across different service systems –
improve the health and wealth of the
particularly social care, health, housing,
nation through research.
education, social security and transport –
Martin Knapp is Professor of Social Policy,
Director of the Personal Social Services
Research Unit and Director of the NIHR * The National Institute for Health Research (www.nihr.ac.uk) provides the framework
School for Social Care Research, London through which the research staff and research infrastructure of the National Health Service
School of Economics and Political Science. (NHS) in England is positioned, maintained and managed as a national research facility. The
Angela Mehta is Finances and Communi- NIHR provides the NHS with the support and infrastructure it needs to conduct first-class
cations Administrator, NIHR School of research funded by the Government and its partners alongside high-quality patient care, ed-
Social Care Research, London School of ucation and training. Its aim is to support outstanding individuals (both leaders and collab-
Economics and Political Science. orators), working in world class facilities (both NHS and university), conducting leading
Email: sscr@lse.ac.uk edge research focused on the needs of patients.
SNAPSHOTS
The impacts of social care services both to has summaries of commissioned studies.
Social care practice in England
the public purse and to individuals in
The School is also currently commis-
England are substantial (Box 1). In 2008,
sioning expert reviews on research
the Department of Health in England In England, social care services are utilised
methods in the field, with a number
announced plans to set up a national by many people and much of the population
recently agreed (for completion by
School for Social Care Research (SSCR), will use such services in their lifetime – the
summer 2010). They focus on:
to be established within the NIHR. The lifetime risk of entering residential or nursing
new School formally began work in May – Randomised controlled trials home care is around one in six for a man
2009 with a budget of £15 million over five – User-led research and one in three for a woman in England. In
years, almost all of which was to be spent 2007–08, 1.75 million adults in England
– Modelling used social care services, with a spend of
on new research.
– Research methods and visual £16.5 billion by local municipalities on social
The School is a partnership between six care for adults, while another £3.5 billion
impairment
leading centres of social care research in was spent by older people on their own care
England. It is directed by Martin Knapp – Observational methods with a focus because they were ineligible for public
(London School of Economics and on learning disabilities financial support.
Political Science) and there are five Asso- – Sexualities in social care research Social care provision in England is provided
ciate Directors: David Challis (University through services and support offered by local
– Outcome measurement overview
of Manchester), Caroline Glendinning authority adult services departments, the in-
(University of York), Jill Manthorpe – Cost-effectiveness dependent sector, third sector organisations,
(King’s College London), Jim Mansell – Large-scale datasets unpaid family and other carers. In 2007–08
(University of Kent) and Ann Netten there were approximately 18,000 care
(University of Kent). Its primary aim is to – End-of-life care research methods homes with 450,000 places for adults and
develop the evidence base for adult social – Social care research and black and 42,000 home care agencies in England, with
care practice in England and so help to minority ethnic groups an additional one million people supported in
improve the quality of care and support their own homes.3 About 1.5 million people
– Research in care homes worked in adult social care, and 5.2 million
experienced by individuals and families. It
will conduct and commission high-quality – Qualitative methods people provided unpaid care (and a third of
them did so for twenty or more hours per
(‘world class’) research to produce new – Systematic reviewing
week).
knowledge (including, where appropriate,
It takes longer to commission research
reviews and syntheses of existing evidence)
projects, but again some progress has been
to inform the development of adult social funding to ask the important questions and
made. Among those projects commis-
care practice in England. improve our understanding of what
sioned are: a scoping study focusing on
works, what doesn’t work and why. This
individualisation of services; an investi-
Consultation and commissioning new School will provide considerable
gation of practice models for social care
The School is consulting with a wide range benefit to the health and well-being of the
practice with carers; a scoping study on
of people interested in social care – population through the new knowledge
care and support for people with complex
whether as users, unpaid carers, paid prac- gained.”
and severe needs, looking at innovations
titioners, providers, managers, strategic
and practice; and a study of the costs and Social care aims to reduce, lessen the con-
decision-makers, and researchers. More
outcomes of skilled support for adults with sequences of, or compensate for disability
than a hundred research suggestions have
complex needs in supported accommo- or disadvantage by supporting families and
been received thus far. One reason is to
dation. Another five projects are soon to communities as well as empowering indi-
identify areas where new research evidence
be commissioned. viduals by lessening their dependence, and
could help to improve practice and so
improve people’s lives. The School is also to improve quality of life. A key objective
Path-breaking initiative is often to support people so that they can
working with an Advisory Board of highly
The NIHR School for Social Care enjoy the ordinary, everyday aspects of life
experienced, motivated individuals; and
Research is the first of its kind. It was the experienced by the rest of the population.
with a User, Carer, Practitioner Reference
initiative of Professor Dame Sally Davies, In this context of a multitude of unan-
Group to develop research ideas and to
Director General of Research and Devel- swered questions about social care, £15
ensure wider involvement in the projects
opment at the Department of Health, who million is modest, but it represents a very
that are funded.
announced the establishment of the School important step in the development of this
The SSCR is now commissioning research with the aspiration that “the new NIHR research area.
projects with a clear element of originality, SSCR … will give researchers the time and
and which have relevance and potential to
improve adult social care practice in
England. Research can be commissioned
For further information visit the School’s website at www.sscr.nihr.ac.uk or contact the
from anywhere – not just from researchers
SSCR (sscr@lse.ac.uk).
in England – but the findings must be rel-
evant to English adult social care. Further ACKNOWLEDGEMENTS
calls for proposals are expected in 2010 and This paper was prepared as part of the work of the Department of Health’s NIHR School
details will be provided on the School’s for Social Care Research. The views expressed in this publication are those of the author
website (www.sscr.nihr.ac.uk), which also and not necessarily those of the NIHR School for Social Care Research or the Department
of Health, NIHR or NHS.
SNAPSHOTS
REFERENCES 2. Commission for Social Care Inspection. Research Progress Report 2008/09, London:
1. Department of Health. Best Research State of Social Care in England 2007–08. Department of Health, 2009. Available at:
for Best Health: A New National Health London: CSCI, 2009. Available at: http://www.nihr.ac.uk/files/Publications/
Research Strategy. London: Department http://www.cqc.org.uk/_db/_documents/S 296542_DeliveringHealthResearchReport_
of Health, 2006. Available at: OSC08%20Report%2008_Web.pdf acc3.pdf
http://www.dh.gov.uk/en/Aboutus/ 3. Department of Health, Research & De-
Researchanddevelopment/Researchand velopment Directorate. Delivering Health
developmentstrategy/DH_4127109 Research: National Institute for Health
Child and adolescent mental

health in Europe
Research on best practice
Dainius Puras and Egle Sumskiene
This snapshot looks at the Child and Ado- Moving up the European policy agenda largely invested in services that contribute
lescent Mental Health in an Enlarged It is stated that European citizens have a to traditional patterns of social exclusion,
European Union: Development of right to a good mental health. This espe- institutionalisation and stigmatisation of
Effective Policies and Practices cially should be true for our youngest children, youth and parents at risk. This
(CAMHEE) project. This European Com- generation, upon whom rest our future creates and reinforces the vicious circles of
mission (EC) funded project aimed to hopes for strong social cohesion, produc- a culture of dependence, learned help-
provide a set of guidelines for effective tivity and better health. Through the lessness, exclusion and a lack of tolerance.
mental health policies and practices. One enlargement of the European Union (EU) Many new EU member states
element of the work was to map research in 2004, as well as in preparations for a acknowledge that they need to undergo a
on best practice with the specific objective World Health Organization (WHO) complicated transition to a system based
of analysing community based child and European Region Ministerial conference on principles of participation, the
adolescent mental health (CAMH) activ- on Mental Health in 2005, the importance involvement of families and communities
ities, specifically focusing on successful of CAMH began to be addressed through and strong primary care involvement.
examples of deinstitutionalisation. The the concerted efforts of the EC, WHO and Moreover, there needs to be an emphasis
research uncovered predominant service national authorities of EU member states. placed on mental health promotion and the
areas, the most frequently targeted client Recommendations of a pre-conference on concept of citizenship as basic prerequi-
groups, philosophies and ways in which Child and Adolescent Mental Health in sites for the good mental health of children
services are structured, budgets, financing Luxembourg in September 2004, as well as and their parents.
and other aspects of service provision. The the final Declaration and Action Plan
most problematic issues identified by the approved in the Ministerial Conference on The CAMHEE initiative: mapping best
research were political passiveness and a Mental Health in Helsinki in January 2005, practice
lack of transparency in some settings. put a clear emphasis on the urgent need for In January 2007 a new EU-wide initiative
the development of effective CAMH in CAMH emerged in Lithuania, through
policies and practices in an enlarged the creation of the CAMHEE project sup-
Dainius Puras is Associate Professor, Europe. Most countries that joined EU in ported by the EC’s Public Health
Institute of Institutional Relations and programme. As noted above, CAMHEE
2004 and 2007 have had to contend with
Political Sciences and Egle Sumskiene is had the objective of providing a set of rec-
major problems in the field of CAMH,
based in the Social Work Department, ommendations and guidelines for effective
revealed by strikingly high rates of poor
Vilnius University, Lithuania. CAMH policy and practice in EU, with a
mental health among children and young
Email: dainius.puras@gmail.com special emphasis on new EU member
people.
states. It was conducted in light of the
Further information on the CAMHEE There remains a concern that in many Declaration and Action Plan endorsed by
project is available at countries in central and eastern Europe WHO European Ministerial Conference
http://www.camhee.eu/ financial and human resources are still on Mental Health in 2005.
PUBLIC HEALTH PERSPECTIVES
The general approach was based on the considerable number of organisations for new EU member states, approximately
understanding that new EU member states (71%) had an agreed procedure for one fifth also indicated deinstitutionali-
have to make proactive concerted efforts arriving at case-formulation through con- sation as an essential element of their
to develop effective approaches to CAMH tributions from their staff members and future activities. A similar trend was iden-
promotion. They need to evaluate the new other sources. Only one third of organisa- tified when analysing targeted problems:
situation, and identify opportunities for tions used data such as the average number institutional stigma turned out to be the
action, as well as gaps to be plugged, by of sessions, duration of care episodes or least interesting issue for respondents, with
drawing on the rich experience of EU15 costs to indicate their involvement with only 23% being active in this area.
countries. One element of the work was to specific cases.
Secondly, we encountered a significant lack
map research on best practice, with the
The majority of organisations (65%) sur- of evaluation culture, evidence based
objective of analysing community based
veyed offered their services for free; almost service evaluation and monitoring. 85% of
CAMH activities, specifically focusing on
one-third (31%) stated that they had a organisations chose to carry out an internal
successful examples of deinstitutionali- mixed system of charging; less than 5% evaluation of services provided, whereas
sation of children with disabilities and fully charged for services. When pricing only 51% were subject to any external
other risk factors. their services, only 16% applied market evaluation. External evaluation is likely to
A bespoke questionnaire was developed prices, while one third used their own be more objective, critical and show the
and disseminated to health, social care and price lists. The remainder employed a real state of the affairs. Organisations in
educational organisations that had some variety of strategies for setting prices. ‘old’ member States more often
responsibility for CAMH. This research Projects, rather than maintenance grants, acknowledge the importance of such eval-
was conducted between May and July, are the main source of financing (58%), uation, unlike the situation in eastern and
2008. Sixty-four questionnaires were com- which raises questions about the sustain- central Europe where they remain com-
pleted by experts in Lithuania, Bulgaria, ability of some services. The respondents mitted to internal evaluation. This
Norway, Germany, Belgium, Latvia and identified two key sources of funding: situation reflects different democratic tra-
Greece. Forty-seven organisations were local government (26%) and central gov- ditions, attitudes towards clients, quality
from new member states. Data were ernment (20%). 22% supplemented public of services and a lack of constant verifi-
analysed using the Statistical Package for funds with their own income, largely gen- cation of compliance with national mental
Social Sciences (SPSS) and Microsoft erated through fees paid by service users, health policy.
Excel. Descriptive statistics were applied as well as membership subscriptions,
to the data analysis. Interestingly, several organisations from
donations and the time of volunteers.
new member states claim to use informal
Survey results The majority of the organisations are conversations instead of any official com-
Approximately two-thirds of participant autonomous (60%), while one-third are plaints mechanism, implying that
organisations indicated that their main integrated into other services (33%). When unregistered complaints do not appear in
service domain comprised of primary and integrated, organisations usually noted the records. This may hide dissatisfaction
secondary prevention (66%), psychosocial that they held a special position, having with services provided. Sharing experience
care (64%) and the provision of educa- been founded by an institution (for of best practices and moving towards a
tional services (61%). Families were most example, a municipality or hospital) but better culture of evaluation and evidence
frequently targeted, with 92% of organi- enjoying extensive autonomy. One of the based decision making process would help
sations providing services to families. organisations described its functioning as to identify strengths, weaknesses and chal-
Emotional and conduct disorders were the separate and autonomous but dependent lenges for the development of evidence
most frequently targeted problems (70% on specialist care units for service pro- based and sector wide national CAMH
and 69% respectively) reported by respon- vision. policies in both the current enlarged EU
dents. Providing services to victims of Despite the fact that research participants and candidate countries.
abuse and individuals with poor parenting were identified as ‘best practice’ examples It is hoped that the outputs of the
skills was also noted as an important (and respondents also stressed their CAMHEE project, allowing for the
activity (62%). achievements instead of problems), the exchange of positive experiences and facil-
79% of respondents emphasised that questionnaires revealed several challenges. itating cooperation across countries, will
teamwork was the overarching service First of all, participants remain inactive in provide a new impetus and support for
provision philosophy. Community-based the sphere of policy development; less than better mental health promotion, mental
one-third (31%) stated they had taken a disorder prevention and treatment for
service provision was the second most
proactive stance. This fact may signal a dis- children and adolescents. However, neg-
essential issue, with two-thirds of organi-
crepancy between services provided and ative factors, like the apparent lack of
sations surveyed mentioning its
priorities in national mental health policy. external evaluation and political pas-
significance. More than half indicated
Gaps in legislation, coupled with unclear siveness of some research participants in
using client involvement (58%), a risk
mandates for different actors in the field,
management approach (53%) or individual new EU member states, allow us to
have created uncertainty, with overlapping
engagement-based care (53%). The most presume that this is only the tip of the
services on the one hand and serious gaps
popular way (81%) of service structuring iceberg and that there is much more to do.
in service provision on the other.
was to offer training to non-medical Child and adolescent mental health
clientele to implement interventions, as Though human rights violations for indi- requires much more academic, political
well as increasing the competence of pro- viduals in residential mental health and social awareness, as well as support
fessional staff, including psychologists. A institutions represent significant challenges and incentives for further development.
Periodic Health Examination –

A brief history and critical assessment
Walter Holland
Summary: The development of the periodic health examination (PHE) is outlined

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

public health policy
The start In the United States (US), the public health medicine saw the examination as serving
D’Souza,1 stated that the origins of the use of screening probably first became the instrumental purpose of enhancing the
Periodic Health Examination (PHE) or established in the mid 19th century when, position of the practitioner in the com-
screening occurred in a brothel in the papal in conjunction with quarantine regula- munity, particularly in the wake of its
state of Avignon in 1347, “when an abbess tions, it was applied to immigrants. Its opposition to compulsory health
and a local surgeon, every Saturday, singly value in checking the flow of epidemics insurance. However, it has to be noted,
examined women ‘in the home’ and if any was taken for granted and at no time was that in the early 20th century, there was a
of them had contracted any illness by their its effectiveness tested. At the beginning of great deal of neglect of periodic health
whoring, they were separated from the rest the 20th century, medical examinations examinations and apathy from the public.
and not allowed to prostitute themselves were recognised as being of use to The benefits of screening were first
for fear the youth who had to do with insurance companies for the purpose of demonstrated by the use of mass miniature
them should catch their distempers.” This rejecting or loading the policies of poor radiography (MMR) for the identification
account is an early record of screening risk clients. The terms PHE and screening of individuals with tuberculosis. The use
applied in the cause of community med- have similar meanings and are used inter- of MMR became common in many coun-
icine and antedates by at least five changeably. tries with the introduction of effective
centuries, the use of medical examination treatment for tuberculosis after 1946. With
for the apparently healthy to prevent the PHE in the US the reduction in the burden of tubercu-
spread of disease. In the US, the first universal PHE pro- losis, the application of screening for other
posals began to appear at the turn of the chronic conditions began to be considered.
The precise origin of PHE is difficult to
20th century. Possibly the first to suggest This was particularly marked in the US,
trace but it has been suggested that the
intellectual beginnings were due to a this was George Gould, a national figure where a law on the control of chronic
British physician, Horace Dobell,2 a in the medical community.3 In 1915, the disease and the availability of screening
renowned clinician, author and expert on National Tuberculosis Association desig- was passed in the late 1950s. A Com-
tuberculosis and diseases of the chest. nated a week for general physical mission on Chronic Illness7 was founded
Dobell proposed the periodic health exam- examinations. This helped popularise these in 1957, and a major review published in
ination as a way to identify “these earliest examinations as a tool for the early diag- the Journal of Chronic Disease.8
invasive periods of defect in the physio- nosis of disease in general, and tuberculosis
There was also the development of what
logical state and to adopt measures for in particular.4
became known as “multi-phasic
their remedy”. Organised medicine also played a major screening”; the performance of multiple
role in the development of the PHE. In tests aimed at detecting unrecognised
Walter Holland is Emeritus Professor of 1922 the American Medical Association disease or defects. The objective was that
Public Health Medicine and Visiting Pro- (AMA) officially endorsed PHE and began screening should involve physicians only
fessor, LSE Health, London School of a campaign to spread its practice in 1923.5 minimally, and be done by using tech-
Economics and Political Science, UK. A manual for physicians was published.6 nology that could be applied economically
Email: w.w.holland@lse.ac.uk George Rosen4 argued that organised and efficiently. First conducted in
California and Massachusetts, this spread consideration of screening for a particular Sackett15 discussed motives for screening,
throughout the US. Prepaid group practice disease.11 These were: suggesting that there were four reasons.
health care was a final important influence Firstly, to influence the gamble of life
1. The condition sought should be an
on the periodic health examination insurance; secondly, to protect people
important health problem.
throughout the mid 20th century. other than the patient, as in industrial and
2. There should be an accepted treatment public health screening; thirdly, to obtain
The most influential experience was that of
for patients with recognised disease. clinical baselines and fourthly, to do the
the Kaiser Permanente Health Plan in the
patient some good, so called, prescriptive
San Francisco area, due to the financial 3. Facilities for diagnosis and treatment
screening. Obviously there are also other
incentive structure of prepayment. An should be available.
motives, such as financial reward and bio-
objective was the satisfaction of over-
4. There should be a recognisable latent logical research, satisfying public and
whelming patient demand for health
and early symptomatic stage. medical demand and gaining information
check-ups. This led Kaiser to seek ways to
for administrative purposes. Many times
maximise the efficiency of the examina- 5. There should be a suitable test or exam-
these are all combined in one.
tions.9 An automated multi-phasic ination.
screening procedure that incorporated 6. The test should be acceptable to the Effectiveness of screening and PHE
computerised test equipment and data population. One of the earliest attempts to demon-
analysis was developed. Opinion polls
strate the effects of screening originated
indicated a growing popular belief in the 7. The natural history of the condition
with the use of screening by insurers.
value of these examinations. However, it including development from latent to
Knight16 produced evidence that such
began to be accepted that the effectiveness declared disease, should be adequately
screening might be effective in saving lives.
should be examined. understood.
He reported that over a five year period,
8. There should be an agreed policy on only 217 deaths occurred, where 303
PHE in the UK whom to treat as patients. would have been expected in an uninsured
The situation in the UK was somewhat population of 6,000. A similar study17 on a
different. In 1926, an experiment was 9. The cost of case-finding (including diag-
population of 20,648 men having employer
established in London at the Peckham nosis and treatment of patients
sponsored PHEs reported a favourable
Pioneer Health Centre.10 This provided diagnosed) should be economically
ratio of actual to expected deaths, but was
not only general practice and medical care, balanced in relation to possible expen-
more cautious in interpretation and rec-
but also family planning advice and routine diture on medical care as a whole.
ommended that prospective studies should
family health screening. This screening 10. Case-finding should be a continuing examine the question.
consisted both of formal medical examina- process and not a ‘once and for all’
tions with laboratory tests and informal There are at least three ways in which false
project.
surveillance. While the purpose of this conclusions can be reached in this field.
screening was not simply to act as a disease Firstly, regression towards the mean, a
Definitions and objectives
sieve, it was a natural, though incidental, natural tendency for high or low readings
In 1968, the Nuffield Provincial Hospitals
part of the general aim of promoting health on one occasion subsequently to be nearer
Trust produced a book12 which dealt with
and attending the health centre. Nothing their mean level, may easily, and erro-
the current state of the art of screening for
short of a periodic health overhaul on a neously, be interpreted as clinical
a number of conditions. The general tone
national scale, the health centre thought improvement in longitudinal screening
of this book was less enthusiastic than the
could lead to the rational application of follow-up studies. Secondly, the increased
literature of the preceding century. A series
medical science and the elimination of survival, of say, a cancer patient after
of articles in the Lancet13 was also more
sickness! When the National Health detection by screening might be inter-
critical of screening and it emerged that
Service was established in 1948, the lessons preted as a benefit of early diagnosis but in
most of the good evidence in favour of
learned from the Peckham experiment fact, be a reflection of the so-called ‘lead’
screening centred around pregnancy and
were ignored. Unlike the US there was no time, that is that the total duration of the
early childhood. Following this series of
comparable demand for PHE. disease process has itself remained
articles, letters to the Lancet revealed ele-
unchanged, but since the diagnosis was
ments both of confusion and dissent in the
PHE in other countries and WHO made earlier, the patient appears to survive
debate on whether public health services
longer. Finally, there is the danger that the
guidance should increase their involvement with
net of any screening process will tend to
Experiments and practice in PHE were screening. Sackett and Holland,14 in char-
select out the more chronic and least severe
also undertaken in Australia, Canada, acterising the opposing teams as ‘snails’
diseases which by definition, will have a
France, Germany, Ireland, Israel, Italy, and ‘evangelists’, produced a cogent expla-
more favourable, clinical cause - again,
Japan, New Zealand, Norway, Scotland nation of the main elements in the debate.
tending to suggest that screening was ben-
and South Africa. Despite the enthusiasm, They observed that the key to much of the
eficial.
or perhaps because of it, in the late 1960s, argument lay in confusion over the use of
the value of screening (periodic health terms, particularly what was meant by Rodney Beard in 1959, an influential voice
examinations) began to be tested and screening or PHE. There is still no univer- in the US, suggested that periodic medical
examined more critically. WHO commis- sally accepted definition, and most doctors examinations should be examined more
sioned a comprehensive review of simply look upon screening (or PHE) as critically. He pointed out that there were
screening worldwide which enunciated ten the use of any sort of test to identify pos- two factors in PHE: disease detection and
common sense criteria to be applied before sible disease. health counselling. The randomised con-
trolled trial undertaken at the Kaiser Per- tified and then randomly allocated, by review as two controlled trials were
manente was one of the first to examine the family and within a general practitioner omitted20, 21 and the assessment of the
problems of periodic medical examina- list, into two equal groups, designated methods and results of others, was not
tions.18 About 10,000 people were chosen ‘control’ and ‘screening’. The screening very critical (for example, 18, 22).
at random from the 46,000 who were Plan group, numbering 3,297, was invited by
members in1964, and they were then ran- personal letter from their general practi- Changes in attitude in recent years
domly divided into equal control and tioner to be screened. Opinion has changed in the United
treatment groups. The first seven years of Kingdom over the past twenty years.
The overall response rate of those
the study were evaluated and comparisons Whereas in the 1960s, PHE’s were pro-
attending for screening was 73.4%. Subse-
made. Overall death rates were not signif- moted by the medical profession and
quent to screening, all information was
icantly improved in the screening group.19 disregarded by the population , now the
passed to the general practitioner who then
However, two specific causes of mortality, medical profession considers them to be of
did a physical examination on each subject
in particular age groups, did appear to be dubious value and view them with scep-
and decided on further tests, diagnosis and
significantly improved in the screening ticism .
treatment. The same group of patients
group. But as sixty significance tests were
were invited to re-attend the screening A recent article in the consumer magazine
performed on these mortality data, this is
clinic in 1969, the response this time was Which,25 cautions the population on the
approximately the same outcome that one
somewhat lower being 65.6%. Both the use of these check-ups which cost, on
would expect purely by chance. The
control and screening groups were average, £423, particularly the use of scans
authors failed to make this point clearly in
examined after seven years and their levels on people without symptoms. It empha-
the discussion of their results. Morbidity
of function were assessed. Overall, the sises the need to link the check-up with
measures, such as physician consultation
mortality in the screening and control pop- appropriate interventions through the
rates and hospital admission rates did not
ulation was not significantly different. No NHS. A commentary in the BMJ by a
significantly differ between the groups.
significant difference appeared between the general practitioner26 also notes a sound of
There was little change in these findings at
study and control groups for any of the caution – “in the public psyche there is an
sixteen years.
various causes of death. There were no sig- unshakeable belief that screening is a good
A further controlled study was undertaken nificant differences in certified sickness thing. But many doctors, myself included,
by Olsen, Kane and Procter, on smaller absence, use of home help or hospitali-
are sceptical of the absolute benefit of
numbers and over only three years.20 This sation between the control and screening
screening; the simplicity of the claim that
failed to show any measurable morbidity populations. There appeared to be a higher
‘early diagnosis’ saves lives is too seductive
benefit in favour of screening. overall consultation rate observed in the
and open to confounding to be wholly
screening population compared to the
A well designed controlled trial of true” and continues “tear stained reasoning
control, but that could perhaps be because
screening was carried out in Malmö, should not blind us to the fact that
of the need to investigate the findings at
Sweden, in 1970.21 Men born in 1914 and screening for skin, breast, cervical and
the initial screen. The economics of
residing in the town were randomly allo- prostate cancer (not to mention screening
screening showed that, if introduced in the
cated to screening and control groups. for high cholesterol, hypertension or
total population, it could increase costs to
Following screening, intervention concen- osteoporosis) generates overdiagnosis,
the National Health Service by about 10%,
trated upon treating blood pressure greater overtreatment and health anxiety. Doctors
largely because of the examinations which
than 165/110 and smoking. After four are complicit in the theft of society’s most
had to be done following screening. Thus,
years the death rate in the two groups was precious possession of all; a sense of well-
the value of periodic health examinations
not statistically significantly different, being. So let’s repeat: screening, whatever
(or screening), in this population in the
however, there was a significant shift in the its benefits, also causes widespread, real,
UK was doubtful.
causes of death. Twice as many men died and lasting harm.”
of cardiovascular disease in the control In Japan, comprehensive periodic health
group. This was offset by nearly twice as examinations have been undertaken for The aims of health policy – improvements
many deaths from cancer and other causes many years. There is little evidence of any, in health – recent development
in the screening group. As the authors did other than belief, that it is of any value. Health measures are intended to improve
not provide any evidence that they had Analysis of the procedure showed that it health. The aim of screening and PHE is
lowered blood pressure and smoking levels increased health care utilisation and costs. intended to identify symptoms and signs
in their screening population over the four The only possible benefit was that there in individuals at a stage when the condition
year period, it might well be that the was an increase in health care utilisation.23 is treatable and reversible. An alternative
observed difference in their screening pop- for health improvement and reduction in
A more recent systematic review of the
ulation over the four year period was due the burden of common diseases which
value of periodic health evaluation in
to random fluctuation rather than the have their roots in life-style, social factors
2007,24 was unable to show any
screening programme. and the environment depends upon a pop-
improvement in outcomes in any of the
A further randomised controlled trial was studies examined. The authors concluded ulation-based strategy of prevention rather
undertaken in England by the Department that PHE improves delivery of some rec- than an approach to identifying and
of Clinical Epidemiology and Social Med- ommended preventive services and may treating ‘high-risk’ individuals. These
icine at St. Thomas’ Hospital and group lessen patient worry, although additional alternatives have been analysed by Rose27
general practices in St Paul’s Cray in research is needed to clarify the long term who concludes that a population-based
Kent.22 Within two large group practices, benefits, harms and costs of receiving the approach is better and more cost-effective
all persons aged 40-64 in 1967 were iden- PHE. This was not a very comprehensive for common diseases. For relatively
uncommon conditions screening may be propounded by Rose27 is neglected in the mortality among the populations.30 Con-
better if an effective form of treatment is UK. Cardiovascular disease (CVD) (and versely, rapid rises in CVD mortality have
available. There have been many publica- risk factors) is extremely common in the been seen in China and elsewhere, princi-
tions reviewing individual screening tests UK population and part of health policy is pally due to the adoption of a Western diet
(for example Holland and Stewart 28). to reduce inequalities. Common diseases rich in saturated fats.31
Some health administrations have estab- have their roots in life style, social factors
Interventions which rely on people
lished national bodies responsible for and the environment. Successful improve-
deciding to change their behaviour are
reviewing individual tests and procedures ments in health must be based on
likely to vary in effectiveness. For example,
(for example, UK National Screening population strategies. It is far more
people who are disadvantaged might find
Committee, US Preventative Services Task effective to change the population mean
it more difficult to change than affluent
Force). levels of risk (such as smoking habits or
people. As a result, some interventions that
cholesterol level) rather than to tackle indi-
In spite of all these reservations identified focus on changing behaviour may inadver-
viduals with high risk levels, as is envisaged
by research, the UK government is tently increase health inequalities. To
in the concept of ‘vascular checks’. Popu-
planning to implement ‘Health Checks’ in overcome this, the recommendations do
lation strategies are a far less attractive
England for all individuals aged forty and not, in the main, rely on individual choice
public relations option and are more dif-
over. These proposals have not been but, rather, aim to make the healthy choice
ficult politically, but would have a more
included in the procedures approved by the easy choice. Hence, the emphasis is on
profound effect in improving the levels of
the UK National Screening Committee changing policies, systems, regulations and
health of the UK population.
since they do not meet its stringent criteria. other similar ‘upstream’ factors. This
The term ‘health check’ is also a misnomer, In the most recent document for the pre- approach is likely to reduce, rather than
what is intended is a structured risk vention of CVD at population level issued increase, health inequalities and is con-
assessment in general practice for coronary by the National Institute for Health and gruent with NICE’s guidance on
heart disease, cerebrovascular disease and Clinical Excellence (NICE) the draft behaviour change.
type II diabetes. Economic assessment has guidance states “interventions focused on
The use of preventive health examinations
been done on the basis of a number of individuals have tended to dominate CVD
or multi-phasic screening may be justified
complex models. The modelling shows prevention activities. However, the largest
for populations that have few medical facil-
that the impact of the programme would overall benefit could be achieved by
ities, or organised health systems, to
be significantly beneficial. The total cost making changes (albeit small ones) within
identify those individuals who require care
per ‘Quality Adjusted Life Year’ is esti- the population as whole. As indicated by
or treatment. In most developed countries
mated at about £3,500, which is considered the Rose hypothesis,27 a small reduction in
individuals have easy access to health facil-
to be a very good use of NHS funds by the risk among a large number of people may
ities so that benefits to improve the
government. prevent many more cases, rather than
population’s health through these
treating a small number at higher risk. A
Periodic health checks and screening are measures are difficult to identify. The occa-
whole-population approach explicitly
now very popular procedures. A priori sional individual may benefit – but at the
focuses on changing everyone’s exposure
they should be effective in reducing the cost of harm to others. It is for this reason
to risk. This may be best achieved through
burden of disease and improving well- that WHO, US, Canada, the UK and other
‘upstream’ interventions: fiscal measures
being. Unfortunately the reality seems to health authorities have introduced clear
(including taxation), national or regional
be less attractive. Most of the proponents principles by which screening measures
policy and legislation (including, for
neglect the unfortunate side-effects of should be assessed before introduction to
example, legislation on smokefree public
increasing anxiety, overtreatment and medical practice. PHE is an attractive com-
places or the way food is produced).
overdiagnosis which have been well- mercial undertaking leading to the
documented.26,28 The results of ran- Social and economic action can also result consumption of drugs and the use of diag-
domised controlled trials which assessed in a change in CVD risk (in such cases, the nostic equipment. The stake that industry
outcomes such as mortality, morbidity and health outcomes are side effects – albeit and advertising have is exemplified by the
disability have not confirmed the hopes of desirable). Voluntary action may be unscrupulous behaviour toward those who
the well-intentioned proponents, in spite effective. Sometimes, however, it may need are more questioning.28 It is also, superfi-
of changes in some of the risk behaviours to be supported by mandatory measures, cially, very attractive to the layman, after
and increase of health service utilisation, for instance, when the pace of change is all our cars have to be tested and examined
particularly in countries with a competent insufficient. Data from ‘natural experi- regularly to ensure that the engine and
primary care system. It is unfortunate that ments’ in a whole population (where there brakes work. Thus health policy and politi-
health authorities, worldwide, have neg- were no randomised controlled trials to cians reacts favourably to such populist
lected the need to conduct rigorous, assess the results) provide compelling evi- procedures – but completely neglects that
long-term, pragmatic controlled trials with dence. One example is the reduction in the all such examinations are fallible, leading to
appropriate outcome measures and rely on consumption of animal fats in Eastern unnecessary further tests, the induction of
superficially attractive policies based on Europe, following the break-up of the anxiety and to being ‘labelled’ ill.
modelling and ‘expert opinions’ or process Soviet Union (29). Another example is the
measures. This short-termism is an unfor- introduction of legislation in Mauritius to
tunate manifestation of all current policies make it mandatory to use polyunsaturated REFERENCES
– whether it be economic or health. The oils as a substitute for highly saturated 1. D’Souza MF. Early diagnosis and multi-
divide between snails and evangelists per- cooking oils. In such cases, there has been phasic screening. In: Bennett, AE (ed).
sists. It is unfortunate that the lesson a remarkably rapid reduction in CVD Recent Advances in Community Medicine.
London: Churchill, 1978. 18. Cutler J, Ramcharan S, Feldman R, et 24. Boulware EL, Marinopoulos S, Phillips
2. Dobell H. Lectures on the Germs and al. Multiphasic checkup evaluation study. KA et al. Systematic review: the value of
Vestiges of Disease, and on the Prevention I – Methods and population. Preventive the periodic health evaluation. Annals of
of the Invasion and Fatality of Disease by Medicine 1973;2:197–206. Internal Medicine 2007;146:289–300.
Periodical Examinations. London: 19. Ramcharan S, Cutler JL, Feldman R, 25. Which? check-ups on private health
Churchill, 1861. et al. Multiphasic evaluation study. 2. MOTs. Which 2009;August:20–23.
3. Gould GM. A system of personal Disability and chronic disease after seven 26. Spence D. When it’s worth repeating.
biologic examinations; the condition of years of multiphasic health check-ups. British Medical Journal 2009;339:244.
adequate medical and scientific conduct of Preventive Medicine 1973;2:207–20.
27. Rose G. The Strategy of Preventive
life. Journal of the American Medical 20. Olsen DM, Kane RL, Procter PH. A Medicine. Oxford: Oxford Medical
Association 1900;35:134–38. controlled trial of multiphasic screening. Publications, 1992.
4. Rosen G. Preventive medicine in the New England Journal of Medicine
1976;294:925–30. 28. Holland WW, Stewart S. Screening in
United States, 1900-1975. Trends and
Disease Prevention, What Works?
Interpretations. New York: Science 21. Lannerstad O, Sternby NH, Isacsson Abingdon: Radcliffe Publishing, 2005.
History Publications, 1975. SO, Lindgren G, Lindell SE. Effect of a
health screening mortality and causes of 29. Zatonski WA, Willett W. Changes in
5. Emerson H. Periodic medical
death in middle-aged men. Scandinavian dietary fat and declining coronary heart
examinations of apparently healthy
Journal of Social Medicine 1977; 5:137–40. disease in Poland: population based study.
persons. Journal of the American Medical
British Medical Journal 2005;331:187–89.
Association 1923;80:1376–81. 22. South East London Screening Study
Group. A controlled trial of multiphasic 30. Dowse GK, Gareeboo H, Alberti KG
6. Council on Scientific Affairs. Medical
screening in middle-age: results of the et al. Changes in population cholesterol
evaluation of healthy persons. Journal of
South-East London Screening Study. concentrations and other cardiovascular
the American Medical Association
International Journal of Epidemiology risk factor levels after five years of the
1983;249:626–1632.
1977;6:357–63. non-communicable disease intervention
7. Commission on Chronic Illness. programme in Mauritius. British Medical
Chronic Illness in the USA. Vol.1. 23. Ren A, Okubo T, Takahashi K. Com- Journal 1995;311:1255–59.
Prevention of Chronic illness. Cambridge, prehensive periodic health examination:
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MA: Harvard University Press, 1957
in a working population in Japan. Journal Capewell S. Explaining the increase in
8. Breslow L, Roberts DW (eds). Screening of Epidemiology and Community Health coronary heart disease mortality in Beijing
for asymptomatic disease. Journal of 1994;48:476–81. between 1984 and 1999. Circulation
Chronic Disease 1955;2:363–490. 2004;110:1236–44.
9. Collen MF. The multi-test laboratory in
health care of the future. Hospitals
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Experiment. London: George Allen and Nordic Health Care Systems
Unwin, 1943. Recent reforms and current policy
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Practice of Screening for Disease. Geneva:
World Health Organization, 1968.
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Richard B. Saltman
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13. Various papers in a series on ‘Screening
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in the detection of disease. The Lancet features across all five Nordic countries: tax-based funding, publicly owned
1975;2:357–59. and operated hospitals, universal access based on residency and
15. Sackett DL. Screening for early comprehensive coverage. The reality is considerably more complex, with great
detection of disease. To what purpose? variation at the structural level in the way that institutions are designed and
Bulletin of the New York Academy of at the policy level in the way strategies are conceived and implemented.
Medicine 1975;51:39–52.
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examination. Statistical Bulletin of Metro- systems, including the balance between stability and change in how these
politan Life Insurance Company 1921;2:1. systems have developed. Detailed comparisons are undertaken along a
17. Roberts NJ, Ipsen J, Elsom KO, Clark variety of policy-driven parameters.
TW, Yanagawa H. Mortality among males
in a periodic health examination program. Freely available at: www.euro.who.int/observatory/Studies/20091021_2
New England Journal of Medicine
1969;281:20.
The EU School Fruit Scheme:

Integrating public health into mainstream policy
Felix Mittermayer and Robert Pederson
Summary: Public Health is often considered as a European Union (EU) policy,

which lacks immediate tools and funds to deliver concrete results to Europe citizens.
One way forward to broaden the approach of public health within the framework
of EU policies is to integrate its objectives into mainstream policies. A prime example
of placing public health interests into other policy areas is the recently launched
‘School Fruit Scheme’ which, although small as a programme, offers the opportunity
to establish public health objectives within one of the longest running and best
funded EU policies – the Common Agriculture Policy.
Key Words: Common Agriculture Policy, Europe, European Commission, diet, public
health
On 22 July 2009, the European Com- Policy (CAP), one of the core competence demand: Member States’ competent
mission announced the allocation of EU areas of the EU with a long history and authorities are given funding to purchase
funds to the twenty-two Member States substantial funds.5 products of their choice on the market.
participating in the ‘School Fruit Scheme’ Eligible products are defined as all fresh
(SFS).1 This is a landmark decision for Public health objectives and processed fruit and vegetables,
public health because for the first time, a For the first time, the rather general Article including tropical fruit and bananas from
key EU policy has integrated public health 152(1) of the Treaty requiring “a high level third countries. Products that contain
interests as an implicit policy objective. of human health protection in all Com- added sugar, salt or fat are not eligible, and
munity policies” is implicitly used to products incorporated in national schemes
The SFS aims to improve children’s diets
establish a concrete and well-funded policy must be approved by a competent Member
by sustainably increasing the consumption
measure within an EU mainstream policy, State health authority. This clearly gives
of fruit and vegetables through the creation
the CAP. The sustainable increase of priority to health objectives, compared to
of healthy eating habits. Increasing fruit
demand for fruit and vegetables by cre- other schemes that give priority to market
and vegetable consumption is a public
ating healthy eating habits in children does impact objectives.
health priority as defined by the World
not merely aim at increasing quantity (i.e.,
Health Organization (WHO)2 and by the Furthermore, accompanying measures
calories from agricultural produce) but
EU.3,4 Specifically, the EU SFS targets must be defined by Member States in order
also at improving the quality of children’s
children early in life by increasing accessi- to receive funding. Accompanying
diet with the long term goal of improving
bility to fruit and vegetables in school measures aim to proactively integrate
public health. In contrast, other EU agri-
environments. parents and teachers and link the scheme
culture policy measures, such as School
to public health, education and agriculture
As of September 2009, there will be an Milk and Food Aid to Most Deprived
in a comprehensive effort to create envi-
annual budget of €157M (of which €90M Persons (MDP), were originally created to
ronments that support healthy eating
(57%) are Community funds) available to dispose of surplus products in order to
habits in children. Although these
Member States to provide fruit and veg- relieve the respective markets, and have
measures receive no direct EU support,
etables as part of a newly established or failed to address public health goals.
they are to be defined in the strategy
expanded SFS. The EU funds will come
The SFS, on the contrary, is driven by clearly demonstrating their contribution to
from within the Common Agriculture
the scheme’s overall objectives.
A key element of the policy management is
Felix Mittermayer is Policy Analyst at DG SANCO/02, European Commission and the ‘Strategy’, which must be developed
previously worked in DG AGRI on the EU School Fruit Scheme from its inception. for each geographical level, i.e. national,
Robert Pederson manages the European Agriculture and Health Consortium (EAHC), regional or municipal, for which the
a Brussels-based alliance of health organisations whose main aim is to advocate for health respective Member State chooses to create
promoting agriculture policy. a SFS. Only a limited number of criteria
Email: robert.pederson@healthyagriculture.eu are obligatory, such as the budget,
duration, and target group, a list of eligible lying problem, as well as on-going initia- mainly defined in terms of quality of pro-
produce, stakeholders and accompanying tives in the Member States, and duction. Human health is not a criterion in
measures of a SFS. consequently to create public support for establishing EU funding in investment
the proposal. On the other hand, it aims to support or direct payments.
Strategies have a dual purpose: to ensure
create positive peer pressure on Member
that programmes meet the objectives set However, public health could be a crucial
States by publishing all relevant docu-
forth by the Commission and to provide a partner in delivering legitimacy to con-
ments, notably the Strategies as well as
framework for evaluation and comparing tinued CAP funding for European farmers
monitoring and evaluation reports. The
Member State schemes. Strategies are through the creation of a full-fledged EU
interested public will thus be able to judge
multi-annual, providing a sustainable food quality policy6 with the objective of
for themselves about the effectiveness of
framework and avoiding short term reconciling quality of production with
the scheme in their respective Member
political and budget constraints to ade- quality of consumption for food. This
States. In addition, this transparency will
quately combat the long term problems would require creating a horizontal
facilitate the comparison of schemes
associated with poor nutrition and obesity. approach within the EU’s agriculture
between Member States and foster the
development of best-practice examples. policy to enhance quality and diversity
The ‘Strategy’ itself is not formally
throughout the whole food chain, ensuring
approved by the Commission but sub- Unfortunately, recently published a positive health impact and the highest
mitted for information and publication. strategies illustrate several problems at EU possible food safety standards for all agri-
The main objective of this document is and Member State levels. The strategies are culture products deemed fit for human
therefore not to fulfil a legal obligation but difficult to understand and compare consumption.
rather to initiate an internal discussion because a standardised format is not used
process in the respective Member States, and strategies are only published in the Consequently, the EU SFS, although small
bringing together the relevant stakeholders Member State’s language. Published in budgetary terms and limited in objec-
and sectors to agree on a sustainable strategies also indicate problems with eli- tives, is a first attempt at integrating public
framework for a long term approach. gible products, and may require a stronger health objectives within a programme
definition of eligible or non-eligible directly linked to the market management
Public health in implementation products by the Commission. Ironically, measures within CAP. The programme
Public health experts and stakeholders Greece has only includes processed fruit should not be seen as a small, one off pro-
have played an important role in the design and juice in its programme, which contra- gramme, but rather as a catalyst that has set
of the SFS. They will continue to do so as dicts the original goal of the programme, in motion long term changes within the
the programme is implemented. First, the to increase the consumption of fruit and CAP, introducing public health, with its
design process offered the opportunity to vegetables. stakeholders, their perspectives and new
open up existing Commission platforms approaches, as an integral part of the main-
for interaction with the agriculture sector Establishing both expert and stakeholder stream (agriculture) policy.
(producers, trade and industry) to include groups to address these issues should be a
public health stakeholders and experts. priority to ensure the programme is suc-
This increased cooperation was high- cessful and effective in meeting its goals. REFERENCES
lighted during a major conference, driven Even more so, transparency and accounta-
bility of the SFS should remain as an 1. European Commission decision 5514
largely by pubic health expertise, in final of 22 July 2009.
December 2008 in Brussels, entitled: underlying principle and be ensured by an
overall evaluation to be undertaken by 2. World Health Organization. Diet,
School Fruit: a healthy start for our
independent contractors. The results of Nutrition and the Prevention of Chronic
children – Promoting School Fruit Schemes
this exercise will be reflected in the Diseases. Report of a Joint WHO/FAO
in the European Union.
assessment report from the Commission to Expert Consultation. Geneva: World
Currently, this cooperation is being insti- the European Parliament and the Council, Health Organization, 2003.
tutionalised with the creation of a which is due in August 2012. 3. Commission of the European
permanent expert group to shadow the Communities. EURODIET Core Report.
management and implementation of the Perspectives Brussels: EC Directorate General Health
EU-wide SFS. This tool will provide tech- The discussion on the future allocation of and Consumer Protection, 1998.
nical expertise, i.e., methodology for European funds will take place within 4. Commission of the European
evaluation and monitoring of the SFS. At budget negotiations for the next seven- Communities. White Paper on a Strategy
the same time, it will ensure that the effec- year financial framework 2013–2021. for Europe on Nutrition, Overweight and
tiveness of Member States’ schemes with These are expected to start in earnest in Obesity related health issues. COM(2007)
respect to the overall objective of 2011, corresponding to when the SFS 279 final. Brussels: European Commission,
improving public health is maintained. assessment report is to be published. 2007.
Compared to other voluntary schemes, the Within the EU budget negotiations, the 5. Mittermayer F. Increasing the consump-
SFS has a high uptake, twenty-two of CAP funds will play an important role: tion of fruit & vegetables by school chil-
twenty-seven Member States are imple- similar to the process in the 1980s, when dren: which role for the European Union?
menting the scheme. Throughout the the CAP started to reflect the environ- ISHS Scripta Horticulturae 2008; 8:79–94
policy development process transparent mental impact of agriculture production, 6. Commission of the European Commu-
communication was used, both as an end the focus today is increasingly on the nities. Communication on Agricultural
and as a means. On the one hand, to raise impact of agriculture production on Product Quality Policy. COM(2009) 234 fi-
awareness for the proposal and the under- human health. However, quality is still nal. Brussels: European Commission, 2009.
Policy development and

implementation:
The National Service Framework for Older People in Wales
Gareth Morgan
Summary: In Wales, the National Service Framework (NSF) for Older People sets
out evidence-based standards for the health and social care of individuals age over
fifty years. Launched in 2006, this ten year programme has made progress in the first
three years but further work is needed. This paper offers an overview of the NSF to
date using a framework of six policy factors. This overview is discussed within a
context of the challenges of policy development and the situation in Wales, including
devolvement.
Key words: implementation, National Service Framework, older people,

evidence-based health policy, Wales
In Wales, the National Service Framework some situations do not readily lend them- circular relationship between research and
(NSF) for Older People (Box 1) sets out selves to RCTs being conducted.3 In policy; (iv) the need for policy implemen-
evidence-based standards for the health addition, a strong case for policy devel- tation to be locally sensitive; (v) the benefit
and social care of individuals aged over opment may sometimes be made using of stakeholder involvement; and (vi)
fifty years. This article provides an evidence from sources other than RCTs,4 support by the national government.
overview of progress made on the NSF as such as observational studies. The ethics of
Taking the last of these factors, gov-
an exemplar of the challenges of policy delaying policy implementation in these
ernment administrations differ in the way
development and implementation within a situations has been questioned with the
they are constituted and their powers. In
Welsh context, including the devolution of statement that “waiting for the results of
Wales, which is one of the constituent
health system responsibilities. As a randomised trials of public health inter-
ventions can cost hundreds of lives….if the countries of the United Kingdom with a
framework for analysis it considers factors,
science is good, we should act before trials population of nearly three million resi-
which if not addressed, may lead to
are done”.4 dents, devolution in 1999 transferred a
resistance to policy implementation.
range of policy responsibilities, such as the
A further issue to be considered in the National Health Service (NHS), to an
Policy development and implementation
development and implementation of Assembly of democratically elected
The development of evidence-based health
policy is the need to take account of local members.8 Greater political powers to all
policy is challenging1 and balances a
realities5 and resistance factors to policy of the nations of the United Kingdom in
number of factors which have the potential
change.6 Specific resistance factors have the last ten years have led to divergence in
to be in tension with each other. One of
been described in a case study from the health policies .9 In Wales, there has been a
these factors is the hierarchy of evidence,2
Ukraine about the control of tuberculosis. drive to improve the cohesion between
ranging in strength from meta-analysis of Health service financing and payment
randomised controlled trials (RCTs) health and social care organisations.10 In
systems, coupled to opposition from particular Wales has been particularly
through to the opinion of respected policy makers and clinicians, appear to
authorities. Balanced against this hierarchy, active in the provision of services to older
have combined to create a set of circum- people. In addition to implementing the
however, is the practical consideration that stances which has undermined ten year NSF for Older People, other
tuberculosis control programmes being examples include introducing a Com-
properly implemented in this country.6 mission for Older People.
Gareth Morgan is Project Manager,
National Service Framework for Older More generally, it has been suggested that
People. The post is supported by Welsh the failure to fulfil six factors may lead to The importance and value of multi-disci-
Assembly Government and hosted by resistance to policy change.7 These are: (i) plinary teams
Hywel Dda Health Board, Llanelli, the importance and value of having multi- The NSF for Older People in Wales is
Wales. disciplinary teams; (ii) the need to have a delivered by twenty-three partnerships,
Email: Gareth.Morgan5@wales.nhs.uk broad evidence base to draw upon; (iii) the constituted on twenty-two local authority
digests are disseminated across Wales,

Box 1 : Summary of the NSF for Older People
through a monthly Current Awareness
Bulletin and a quarterly Newsletter. The
The NSF for Older People was launched in March 2006. It sets out evidence-based standards for interest shown in these digests by the part-
the delivery of high quality health and social care services in Wales. It was developed with the nerships varies and a more systematic
advice and support of a wide range of stakeholders, including older people. Phase one of the NSF approach to converting new evidence into
covered the first three years to April 2009 and has primarily set down the structures and practice across Wales could be considered.
foundations underpinning the long term implementation of this programme until 2016. Such evidence is derived from a range of
The NSF is based on eleven standards which address specific service areas, such as stroke, as well sources including the literature and also
as challenging cross cutting themes, such as rooting out age discrimination: professional experience. On the latter
point, the SAAT is an open reporting
Standard 1 Rooting out age discrimination
system allowing partnerships across Wales
Standard 2 Person centred care to review the NSF implementation in
Standard 3 Promotion of health and wellbeing other areas.
Standard 4 Challenging dependency The circular relationship between re-

Standard 5 Intermediate care search and policy
Research can take many forms and from
Standard 6 Hospital care
the outset of the NSF there has always
Standard 7 Stroke been an intention for an independent
Standard 8 Falls and fractures review to be conducted on progress being
made. This review is currently underway
Standard 9 Mental health by Health Inspectorate Wales (HIW) and
Standard 10 Medicines in older people Care & Social Services Inspectorate Wales
(CSSIW). The review, the first one under-
Standard 11 Workforce development
taken jointly by the inspectorate agencies,
The Self Assessment Audit Tool (SAAT) is an internet based reporting system which is used as one will report later in 2010 and will inform the
of the systems to monitor the NSF implementation. The SAAT, which has strengths and weaknesses, policy direction of the NSF between 2011
offers evidence that implementation against the phase one targets and milestones for the standards and 2016.
have been largely achieved across Wales. There is, however, variation across Wales within this
overall picture and there is further work to do in a number of areas. The review is being driven by the question:
What impact has the NSF for Older
For example, the implementation of the mental health standard appears wide ranging across
People had in Wales? Three cross cutting
Wales. The developing Dementia Action Plan in Wales will be helpful to progress this standard
further forward. There are also issues of information sharing that have challenged the NSF themes will be evaluated, namely dignity
implementation. Different organisational boundaries and information technology systems between in care, nutrition and integrated services.
health and social care services have resulted in difficulties in capturing all pertinent evidence. This The inspection agencies have consulted
experience perhaps illustrates a wider issue of collaborative working in the provision of integrated with key groups, such Age Alliance Wales
services; although in Wales this is mitigated to some extent by an increasing drive toward joint (which consists of voluntary organisations)
commissioning of services. and Care Forum Wales (who represent the
independent care home sector), about how
best to engage with key stakeholders, such
areas and one all-Wales service which re-structuring. In Wales, the NHS is cur- as service users and their carers, as part of
delivers national programmes, such as this review.
rently undergoing a major reform leading
cancer screening. The twenty-two local to greater regional working and an abol-
partnerships include health and social care The need for policy implementation to be
ishing of the internal market.
services, both statutory and non-statutory. locally sensitive
The need to have a broad evidence base In Wales, there is variation in the popu-
The partnerships vary in their size, consti- lation sizes of local authority areas, from
tution, frequency of meetings, reporting to draw upon
about 50,000 to 250,000. Variation also
arrangements and internal cohesion. All of The evidence underpinning each of the
exists in terms of population demography,
these factors may influence the NSF diverse NSF standards is broad and was
health profiles and service availability. For
implementation and a small number of initially compiled through systematic
example, the valley communities in South
partnerships have been compromised by searches of the literature. The importance
Wales, former sites of heavy industry such
inter-organisational and inter-personal ten- of this broad evidence base is that it offers
as coal mining, are characterised by a high
sions. a robust approach to policy development.
prevalence of long term chronic conditions
Furthermore, the implementing partner-
Establishing multi-disciplinary teams per and a life expectancy less than the Welsh
ships across Wales can also have
se therefore appears insufficient for proper average. The implementation of the NSF
confidence in the NSF as a quality and
policy implementation and robust profes- in these areas will differ from a large local
contemporary framework for service
sional relationships are also required. Such authority in mid Wales, which borders the
delivery.
relationships take time to develop and English midlands, in which there are chal-
appear to be compromised by factors such Of course, the underpinning evidence base lenges of a mainly rural population.
as staff turnover and organisational continues to progress and evidence-based Language issues are also a factor, for
example areas in the mainland and the two NSF, contrasting with the situation on the medicine. British Medical Journal
islands of North West Wales have a high NSF for children, yet this per se has not 2006;333:701–3.
number of speakers for whom Welsh is the been a barrier to implementation since the 5. Potter C, Harries J. The determinants of
first language of choice. NSF is about an integrated and holistic policy effectiveness. Bulletin of the World
approach to health and social care pro- Health Organization 2006;84(11):843.
The benefit of stakeholder involvement vision. Given that the population is ageing
6. Morgan G. Evidence based health
As well as the independent review, there is and the financial challenges facing society,
policy: A preliminary systematic review.
a close working relationship between the a holistic approach offers advantages of Health Education Journal (in press).
Welsh Assembly Government and the efficient and effective services.
twenty-three partnerships across Wales. 7. Atun R, Olynik I. Resistance to
implementing policy change: the case of
This includes quarterly meetings held on a
the Ukraine. Bulletin of the World Health
regional basis, namely Mid and South References
Organization 2008;86(2):147–54.
West, South East and North Wales. These 1. Kemm J. The limitations of ‘evidence-
meetings provide a forum for all aspects of 8. Drakeford M. Health policy in Wales:
based’ public health. Journal of Evaluation
the NSF to be discussed and debated by a Making a difference in conditions of
in Clinical Practice 2006;12(3):319–24.
group of professional stakeholders who difficulty. Critical Social Policy
2. Concato J, Shah N, Horwitz RI. 2006;26(543):543–61.
are implementing the standards.
Randomized, controlled trials,
9. Greer S. Devolution and divergence in
In addition, an Implementation Advisory observational studies, and the hierarchy of
UK health policies. British Medical Journal
Board convened by the Welsh Assembly research designs. New England Journal of
2009;338:78–80.
Government oversees the implementation Medicine 2000;22(25):1887–92.
of the NSF. This Board consist of Gov- 10. Jewell T, Wilkinson J. Health and social
3. Smith G, Pell JP. Parachute use to
care regulation in Wales; an integrated
ernment civil servants, representatives of prevent death and major trauma related to
system of political, corporate and
older people from groups such as the gravitational challenge. British Medical
professional governance for improving
National Partnership Forum for Older Journal 2003;327:1459–61.
public health. Journal of the Royal Society
People in Wales, academic institutions, 4. Potts M, Prata N, Walsh J, Grossman A. for the Promotion of Health
local authority umbrella groups, health Parachute approach to evidenced based 2008;128(6):306–12.
organisations and other partners such as
voluntary sector providers. Whilst
acknowledging the debates and differences
of opinion that occur, the engagement with
all pertinent stakeholders offers a platform Health in the European Union:
for the progression of the NSF. Trends and analysis
Support by the national government
In Wales, the Deputy Minister for Health Philipa Mladovsky, Sara Allin, Cristina Masseria,
and Social Service, Mrs Gwenda Thomas, Cristina Hernández-Quevedo, David McDaid and
AM (Assembly Member), takes the lead Elias Mossialos
for issues relating to older people. Mrs
Thomas receives briefings on all aspects of Copenhagen: World Health Organization on behalf
the NSF and regularly answers correspon- of the European Observatory on Health Systems and
dence. In addition, the National Dignity in Policies, 2009. 164 pages.
Care programme in Wales, which is
managed as part of the NSF, was initiated
by Mrs Thomas in October 2007. Most
This new report investigates differences in health status within and between
recently, £100,000 has been set aside by the
European countries. The relationship between living conditions, socio-
Welsh Assembly Government to
economic factors and health is discussed and analysed with the objective
implement a programme of dignity in care
of stimulating a debate and policy action for creating a healthier and more
training across Wales. This training may be
equitable society.
considered to be an integral part of work-
force development in Wales. The support
by the Welsh Assembly Government is The range of living conditions in the European Union has widened
therefore crucial in allowing the NSF to tremendously in recent years and will continue to do so. This diversity has
progress in Wales. translated into varied patterns of health across the region. Public health has
been affected by inequalities in income, education, housing and
Conclusions employment.
In the first three years of the NSF for
Older People in Wales, progress has been The picture that emerges from this review is one of significant improvements
made but challenges remain. These include in most countries; however considerable challenges remain in the context of
specific service areas and also the need to an increasingly diverse and ageing population in Europe.
improve data collection across organisa-
tional boundaries. Interestingly, no specific Freely available at: www.euro.who.int/observatory/Studies/20100201_1
additional money was introduced with the
Are regulations of community

pharmacies in Europe questioning
our pro-competitive policies?
Maria Lluch
Summary: Drawing on a recent European Court of Justice ruling against the freedom
of establishment of community pharmacies in Germany, this article addresses the
tensions in European health care systems that arise between regulating community
pharmacies and striving for competition in order to stimulate better quality services.
It spans the different types of policies that are currently applied to community
pharmacies – restrictions on ownership; restrictions on establishment; registration
and licensing; restricting distribution to pharmacy outlets; limiting opening hours;
and incentives (pricing and reimbursement) – and provides experiences on the impact
of (de)regulation in different Member States. The author concludes by raising some
of the trade-offs when (de)regulating community pharmacies in general and
advocates for liberalising ownership, in particular.
Keywords: pharmacies, Europe, regulation, competition
On 19 May 2009, the European Court of checking and filling prescriptions and tra- Member States and stakeholders justify
Justice (ECJ) ruled against the freedom of ditionally have been involved in the these restrictions claiming that they ensure
establishment of community pharmacies in production of patient-specific preparations. the independence of the service provider
Germany.1 The court case, which lasted for With the growing importance of the over- and facilitate access to pharmaceuticals,
three long years, was questioning the 800- the-counter (OTC) segment of the market whilst guaranteeing equity, quality and safe
year old German Pharmacies Act2 under and of self-medication, they are increas- provision of pharmacy services. These
which only registered pharmacists may ingly acting as health advisers providing restrictions can result in a monopoly for
operate a pharmacy – with a maximum of counselling to patients. Thus, their range of pharmacists. Governments claim to use
three branches; hence, pharmacy chains services covers not only pharmaceutical reimbursement and incentive mechanisms
continue to be banned while pharmacists specialities but also a number of pharma- as a mechanism to counter the ineffi-
continue to enjoy their monopoly. ceutical services to patients including, for ciencies of such monopolies.
Germany is not the only country in Europe example, health promotion activities. As a
with regulations limiting pharmacy own- result of the relevant role that pharmacists The OECD in its 2001 report on Regu-
ership: Austria, Spain or Hungary3 have play in the delivery of health care, com- latory Reform in Ireland contested the
been cited by the German government and munity pharmacies in the majority of the logic of these regulations.4 It argued that
professional associations alike. At the other cases are highly regulated in most Member the creation of a protected monopoly to
end of the spectrum, countries including States of the European Union (EU). Key cross-subsidise unprofitable activities was
the Netherlands, Ireland and the UK3 areas of regulation relate not only to own- not the right solution. In fact, keeping up
hardly restrict ownership although it is ership issues (for example, limitation of with competitors is what usually stimu-
mandatory that a pharmacist, as an ownership to pharmacists, and limits to the lates quality-improving services. This came
employee, is always present and supervises ownership of multiple pharmacies pro- about at a time when the debate on the
the dispensing of prescriptions. hibiting pharmacy chains) but also to the deregulation of public services was taking
establishment of pharmacies (for example, place in several EU Member States.3 One
Why regulate community pharmacies? a needs assessment, or demographic/geo- of the sectors receiving attention was
Pharmacists play a key role in the delivery graphic regulations); registration and health care, including community phar-
of health care. They are responsible for licensing issues; distribution of pharma- macies. The rationale behind deregulation
ceutical products outside a pharmacy; in the pharmacy sector is the expectation
opening hours; and pricing, remuneration that liberalisation will increase competition
Maria Lluch is reading for a PhD, LSE and incentives issues, given that gov- and thus succeed in lowering, or at least
Health, London School of Economics and ernment backed health insurance or general containing (public) expenditure, while
Political Science. Email: m.lluch@lse.ac.uk taxation is the key payer of these services. access to quality pharmacy services will
HEALTH POLICY DEVELOPMENTS
remain stable, if not improved, by the ership and quality of care; in a community commercial support, as well as representing
opening of new outlets. In sum, deregu- pharmacy, quality of care is guaranteed the interests of community pharmacy in
lation claims to make the market more simply by the presence of a pharmacist. dialogue with Government, both at a
efficient whilst key areas like equity and national and European level. In the light of
Liberalising the system by divorcing own-
access are not compromised. these two realities, it is not difficult to
ership from pharmaceutical activity, thus
understand why entities such as CGCOF
Together with deregulation in a number of eliminating restrictions on ownership,
do not support liberalising ownership.
areas of the public sector, the regulation of therefore may have different implications.
community pharmacies in Europe was The immediate implication is the greater The impact of liberalising the ownership of
questioned at European Commission3 and numbers of pharmacy chains, not neces- community pharmacies on other stake-
Member State levels.5 Advocates of dereg- sarily being owned by pharmacists. These holders beyond pharmacy owners or
ulation, such as the Office of Fair Trading are often associated with operational effi- chains and professional pharmacy associa-
in the UK or the Internal Market and ciencies. Moreover, evidence from the UK5 tions is unlikely to be negative.
Services Directorate General at EU level, and Iceland13 indicates that liberalising the Pharmacists would still be required behind
argued that it would stimulate competition market can stimulate competition, the counter, and as far as this happens, the
and improve efficiency. Opponents of including price competition on OTC drugs quality of care is unlikely to suffer: patients
deregulation, such as the Consejo General with consequent benefits for society. At a will receive at least the same quality of
de Colegios Oficiales de Farmaceuticos later stage, market consolidation and ver- care. If price competition on OTCs is also
(CGCOF)6,7 in Spain, or Pharmaceutical tical integration may take place, as has evident then there may be additional ben-
Group of the European Union8 at EU occurred in Norway13 or in the UK in the efits for society.
level, claimed that liberalising community case of the takeover of Boots by Alliance
pharmacies would potentially be detri- Unichem. In the long-run this may run the Conclusions
mental to the delivery of quality services. risk of oligopoly, given that a small number European health care systems need to find
of chains would be the principal players in a balance between the values they are com-
The recent ECJ ruling1 recognising that mitted to – solidarity, equity, availability
the field. This would mean that pharmacists
the rules on ownership and operation of and access to health care – while striving
as professionals would lose their monopoly
pharmacies can be restricted to pharma- for efficiency and competition, providing
but another type of monopoly would
cists has only spiced up the debate. options that benefit the society and help
appear. Although it seems reasonable to
eliminate restrictions in ownership, other contain health care expenditure, in par-
Implications of ownership restrictions ticular to meet the challenge of an
types of mechanism should be designed to
A common set of values for European increasingly ageing population. Restricting
counter too high a degree of market domi-
health care systems – universality, access to ownership has not proven to be a threat
nance by pharmacy chains.
good quality care, equity and solidarity9 – those European values, whilst they seem to
are the pillars resulting from the health Liberalisation also has implications for improve efficiency and competitiveness.
acquis communautaire, hence, Member other stakeholders, such as pharmacist pro-
States and any institution within the EU fessional associations. In countries where This piece of research, although aimed at
would strive to ensure that those are pre- ownership is regulated, these associations the European level, has provided an
served before implementing any policy, play a key role. Governments may delegate overview of experiences from several
act, ruling or recommendation. them the power to ensure that the rules are Member States. More research including
implemented appropriately. Spain offers a analysis of in-depth experiences of the dif-
Some of the restrictions imposed on com- ferent models in operation in all Member
marvellous example in this case. The
munity pharmacies may be justified to a States, looking at each type of restriction
CGCOF represents the interests of all
certain extent. For example, Spain regulates and reform in the field of community phar-
pharmacists holding a license, as well as the
the location for the establishment of pharmacies, is needed to take the case further.
interests of community pharmacy owners
macies, guaranteeing access and
and ensures that regulations are respected. The ECJ ruling1 stated that “Articles 43
geographical equity, to 99% of the popu-
Thus professional, commercial and trade EC and 48 EC do not preclude national
lation,10 whilst in England more relaxed
interests, health care priorities and legal legislation, such as that at issue in the main
regulations it is claimed offer access to (an
issues all fall within the ambit of one insti- actions, which prevents persons not having
arguably inflated) 96% of the population.11
tution. In liberalised markets, as in the UK, the status of pharmacist from owning and
One may therefore contend that regulation
there are two institutions in the field each operating pharmacies”. It should not be
in Spain does more good than harm by
with a different role. The Royal Pharma- concluded that the ECJ wants to preserve
ensuring a very high level of coverage.
ceutical Society of Great Britain is the a regulation that makes our health care
In contrast, some restrictions are not nec- professional and regulatory body for phar- systems less competitive or that the ECJ is
essary for guaranteeing the right to health macists and pharmacy technicians in against pro-competitive policies as far as
care. Restrictions on pharmacy ownership England, Scotland and Wales; the primary the health acquis communautaire is not
may be one example. Advocates for objectives of the Society are to lead, reg- threatened; it only means that often the
restricting ownership claim that it has an ulate, develop and represent the profession ECJ tends to avoid ruling against Member
positive impact on the quality of health of pharmacy. The National Pharmacy State legislation, in particular when there
care delivery. Clearly, the presence of a Association is the trade association for are further implications to be addressed
pharmacist is required to ensure quality of community pharmacy owners and has vir- before liberalisation is achieved. Despite
care12 but this is a completely different tually all community pharmacies enrolled this, steps in the form of recommendations
issue from ownership. There is no evidence within its membership. The Association and later on European directives should
proving the association between own- provides its members with professional and be encouraged to ensure the efficiency
and competitiveness of our health care

systems. However, when formulating pro-
competitive policies, risks associated with
Hospital privatisation in
over-monopoly should also be addressed,
preferably avoiding ad-hoc interventions,
as has been learnt from experiences in
Poland
Norway and Iceland.
REFERENCES Peggy Watson

1. Joined Cases C-171/07 and C-172/07.
Reference OJ C 140 of 23.06.2007, p.11:
ECJ, 19/09/2009. Summary: Hospital privatisation has been highly contentious and has
2. Förster A. Germany’s Pharmacy Scene progressed slowly in Poland. Shortly after winning the 2007 elections, the
Remains a Patchwork. Munich: Goethe Civic Platform Party proposed legislation for compulsory, universal and total
Institut, 2009. hospital privatisation. The law was passed by Parliament but later annulled by
3. Volkerink B, de Bas P, van Gorp N, presidential veto and a fall-back plan for optional hospital privatisation put in
Philipsen N. Study of regulatory its place. This came into force in April 2009. However, the economic crisis has
restrictions in the field of pharmacies. placed a question mark against the new programme. This article outlines the
ECORYS Nederland BV in cooperation social processes involved in the privatisation of hospitals since the introduction
with METRO – University of Maastricht. in 1999 of major health care reform.
Rotterdam: ECORYS, 2007.
4. OECD. Regulatory Reform in Ireland: Keywords: debt, social dialogue, economic crisis, protest, Poland
The Role of Competition Policy in
Regulatory Reform. Paris: OECD, 2001.
5. OFT. The Control of Entry Regulations
and Retail Pharmacy Services in the UK.
The 1999 health care reforms for uniformed services. Following criti-
London: Office of Fair Trading, 2003.
In 1999 Poland went through a series of cisms, the sickness funds were replaced in
6. CGCOF. Argumentario modelo español social sector changes, which constituted a 2003 by a recentralised National Health
de farmacia. [The case for the Spanish ‘second wave’ of reforms in the transition Fund (NFZ – Narodowy Fundusz
pharmacy model] Madrid: Consejo to capitalism. These changes included Zdrowotny). This performed largely the
General de Colegios Oficiales de health, pensions, education and territorial same functions and had a branch in each
Farmacéuticos, 2006. administration. voivodeship.
7. CGCOF. Los Modelos de Farmacia en la
The health care reforms introduced The original decision to set the premium
Unión Europea [Models for pharmacy in
changes in the mechanism of financing laid at 7.5% of taxable income had a critical
the European Union]. Madrid: Consejo
down in the 1997 Law on Universal effect on the subsequent provision of
General de Colegios Oficiales de
Farmacéuticos, 2007. Health Insurance which came into force in health care. The figure represented a sub-
January 1999. This introduced a system of stantial reduction on the level of 10%
8. PGEU-Secretariat. PGEU contribution financing based on the Bismarckian social advocated by health care professionals and
to the internal market consultation. the 10%–11% that had also been men-
insurance model, whereby insurance funds
Brussels: Pharmaceutical Group of the
are raised from a compulsory deduction tioned in earlier bills.1 The issue had been
European Union, 2006.
from taxable income, originally set at vigorously contested during the first half
9. Rys A. The contribution of ICT to the 7.5%. The rate was raised following of 1998, with the action committee
modernisation of European health systems. debates, increasing by 0.25% annually KOROZ (The Committee for the Defence
The European files: eHealth in Europe. between 2003 and 2007 until it reached its of Health Care Reform – Komitet Obrony
Brussels: European Commission, 2009. current level of 9%. Reformy Ochrony Zdrowia) being formed
10. Portalfarma. La farmacia en España. at this time.
The insurance funds were designed to
[Pharmacy in Spain] Madrid: Consejo Gen-
finance the direct costs of health services Given that the income base from which
eral de Colegios Oficiales de
to patients through contracts between premiums were deducted was low, with
Farmaceuticos, 2008.
service providers and purchasers. The many of those in employment on modest
11. Galbraith A. Review of NHS latter originally took the form of sixteen levels of pay and about one-fifth of the
Pharmaceutical Contractual Arrangements. Regional Sickness Funds (kasy chorych), working population officially unemployed
London: Department of Health, 2007. one in each of the new voivodeships at the time, the decision resulted in a sharp
12. PGEU-Secretariat. Why Pharmacies (regions), together with one Sickness Fund drop in the public funding available for
Need Fully Qualified Pharmacists? clinical care.2 Health care funding was
Brussels: Pharmaceutical Group of the pushed below 4% of Gross Domestic
European Union, 2009. Peggy Watson is at the Homerton Product (GDP). Coupled to the fact that
13. Anell A. Deregulating the pharmacy College, Department of Sociology PPSIS, Poland had one of the lowest GDP per
market: the case of Iceland and Norway. University of Cambridge. capita rates in Europe, this represented a
Health Policy 2005;75:9–17. Email: pw125@cam.ac.uk very modest level of funding indeed.3 The
Table 1: Perception of change in extent to which health needs have been met 2000–09. swept by unrest among health care per-
sonnel, including doctors, radiographers,
In the last two years the extent to 2000 2003 2005 2007 2009 medical technicians and ambulance staff.
which health needs are met has (%): However, it was the industrial action of
nurses which seized the headlines. Nurses
Deteriorated 41 39 38 27 25 represented the largest occupational
grouping in Poland, one of the lowest paid,
Improved 3 4 3 4 3 and one most consistently opposed to hos-
pital privatisation. The All-Polish Union
No change 56 58 59 69 72 of Nurses and Midwives (Ogólnopolski
Związek Zawodowy Pielęgniarek i
Source: Polish Social Diagnosis 2009.7
Położnych – OZZPiP) became a visible
political actor at this time. The national
Table 2: Public Hospitals in Poland by Type (December 31st 2007)
union grew out of a local union originally
formed in the town of Włocławek in 1991.
By 1995, when it gained its national
Local Government 517
statute, 86,000 nurses, about one out of
every two employed in hospitals, had
Ministry or central government (except Ministry of Defence and joined.
19
Ministry of Internal Affairs)
Not only had nurses seen no pay improve-
ments with the 1999 reform, benefits such
University/Research Institute 42
as the inflation-link to their salaries had
disappeared. Unrealistic budgets and the
Total non-psychiatric public hospitals 578 increasing proportion of budget expen-
diture being accounted for by drugs meant
Psychiatric hospitals 52 extreme downward pressure on staffing
costs. While spending on personnel was
Source: Polish Ministry of Health Statistical Bulletin 20089 slightly higher than pharmaceutical costs
in 1999, by 2003 total spending on drugs
was 29% higher than the combined wage
situation was exacerbated by the rising basis for publicly owned hospitals in bill for all categories of health care
costs of pharmaceuticals. In 2007, the pro- Poland to become substantially autono- personnel.4
portion of total health care spending mous and responsible for managing their The Union’s high profile protest action
accounted for by pharmaceuticals was own budgets. After 1993. ownership of included hunger strikes, the occupation of
about 32%, more than the proportion of most public sector health facilities passed state buildings and the blockade of
spending accounted for by either ambu- to the regions and to local government national borders and roads. The gov-
latory or hospital care. The proportion (gminas);8 when a three-tier territorial ernment eventually conceded to the
spent on hospital care meanwhile was rel- division was introduced in 1999, many nurses’ demands and signed an agreement
atively low and roughly the same as the hospitals passed from gminas to larger awarding all health workers a 203 złoty
proportion of spending accounted for by administrative areas known as powiats. (PLN) salary increase. The resulting ‘Law
ambulatory care – about 28%.4 Table 2 shows the number of public hos- 203’ came into force on 1 January, 2001.
pitals in Poland according to ownership in However, since no extra funds were made
Perhaps unsurprisingly, the reforms were
2007.
not popular with the general public.2,5 An available for this purpose and responsi-
opinion poll carried out in 2001 found that According to central statistical agency bility for payment remained with the
74% of respondents thought that health figures from 2002, the most recent directors of health care institutions, the law
care provision had been better before the available, among public hospitals, 38.37 % served to exacerbate the financial diffi-
reform.6 Data from the biennial Polish of beds were in hospitals owned by the culties experienced within the system.
Diagnosis Survey suggest this negative voivodeships and 45.71% in hospitals
opinion has not improved over time (see owned by the powiats.4 Although privati- Hospital debt
Table 1). sation has been legally possible since 1999, Debts, in accordance with the Polish Min-
for political and economic reasons, this istry of Health definition refer to accrued
Restructuring the hospital system process has been slow. By 2007, there were liabilities due, that is, all liabilities whose
Starting with the 1991 Health Care Insti- 170 private hospitals representing approx- payment date has passed and which have
tutions Act, the Polish hospital system imately 23% of non-psychiatric hospitals not been cancelled or become time-barred,
became increasingly decentralised during in Poland. Most were relatively small and where the creditor is entitled to impose a
the 1990s. The law allowed for the exis- in 2007 accounted for only 5.8 % of hos- surcharge on the amount due – but
tence of diverse health care unit owners pital beds.9 excludes the value of loans, share issues,
beyond the Ministry of Health, including and similar.4 During the 1990s, many hos-
regional and local government, other min- Health workers’ protests pitals had accumulated such debts and
istries, non-governmental organisations In the two years following the health these were successively cleared in 1994,
and private bodies. It provided the legal reforms (1999–2000), the country was 1996 and 1997. Hospital debts were also
cleared with the introduction of the 1999 end of 2007. Between the end of 2005 and tapes did not prevent the Civic Platform
reforms. At the same time, hospital the end of 2007, the percentage of debt from coming to power.
restructuring, at a cost of PLN295 million accounted for by unpaid local taxes, land
Among its early actions were high profile
to the state budget, resulted in a decrease taxes, and social insurance contributions
consultations – the ‘White Summit’ (biały
between 1999 and 2002 of more than on behalf of employees fell from just over
szczyt), with stakeholders in health care
92,000 health care staff and 35,900 hospital 43% to about 28% of all debt, largely
change. The health care workers’ unions,
beds. Unions expressed concerns that per- because much of this debt was cleared. On
professional bodies and other social organ-
sonnel reductions had at times taken place the other hand, the proportion of all debt
isations were all present at meetings held
in contravention of official staffing accounted for by amounts owed to the
between January and March 2008. A
norms.10 suppliers of pharmaceuticals and medical
number of points were eventually agreed.
supplies/equipment rose from 20% to
However, contractual rates of payment to These included the right to buy treatment
30%.4
hospitals after 1999 were significantly less to avoid queues, the introduction of
than the cost of services in practice, and modest fees for clinic visits and hospital
this was largely responsible for the fact The politics of privatisation meals, and the right to buy private health
that levels of hospital indebtedness rose Health care has become a highly politicised insurance in addition to, or instead of,
again after the reforms.11 Interest rates on issue in Poland, and health care issues social insurance. The introduction of a
earlier debts, as well as court costs, also played a prominent role in the election basket of guaranteed services was deferred,
contributed to debts spiraling out of which took place at the end of 2007. The while agreement to hospital privatisation
control. Between 2002 and June 2004, the year had seen strikes and other high profile that was optional and partial was secured.
accumulation of debts doubled.1 industrial action by health workers, culmi-
nating in mass protests, most visibly by the Several weeks later proposed legislation
The most recent legislation to relieve hos- OZZPiP nurses’ union. The hub of the was revealed which departed radically
pital indebtedness was introduced in 2005 ‘white protest’ as it came to be known, was from the White Summit agreement. The
(Ustawa z dn. 15 kwietnia o Pomocy Pub- an encampment (the białe miasteczko or new law was to make it compulsory for all
licznej i Restrukturyzacji Publicznych ‘white village’) along the grass verges hospitals – most of which were still inde-
Zakładów Opieki Zdrowotnej). After this opposite the Prime Minister’s Chancellery, pendently functioning units under local
intervention, the level of hospital debt where a request for pay negotiations had authority management – to become busi-
decreased. This was due to the roll-over of been handed in. nesses, thus opening the way for their sale.
many outstanding liabilities, the cancel- A simultaneous newspaper poll indicated
lation of others, as well as the fact that The białe miasteczko dominated the that over half of respondents were against
hospital revenue increased. Warsaw horizon for a short but significant privatisation, as compared with about one
time. During the twenty-seven days of its third in favour (Rzeczpospolita, 8 May
Social health insurance contribution rates existence (from 19 June to 15 July) hun- 2008).
went up year on year between 2003 and dreds of nurses arrived from all over
2007, while at the same time the base to Poland to take part in the protests. The It is unclear what took place between the
which the rates applied improved with protests received overwhelming public March and May policy announcements,
rising incomes and falling rates of unem- support. In a poll carried out by the public however, a former Health Minister,
ployment. The combination of these opinion research centre CBOS in 2007, Mariusz Łapiński, gave his view in a recent
factors meant that health sector income 88% of respondents were in support of the interview stating that ‘there are firms in
from social insurance contributions went nurses, including their hunger strikes. The Poland which are ready to take over
up from PLN31.5 to 42.2 billion between encampment was visited by Warsaw resi- indebted hospitals, firms which bought
2004 and 2007.4 dents, politicians, as well as figures from hospital debts earlier on. The lobby acting
academia and the arts who also voiced their on behalf of these firms has been forcing
Nevertheless, the question of hospital
support. The protest ended without nego- through changes in the law which to allow
underfunding was far from resolved. For
tiations when Parliament dissolved. this kind of operation’.3
example, a 2008 monitoring survey of psy-
chiatric in-patient care found that During the election campaign, the Central The new proposals were eventually put to
contracts with the NFZ in general covered Anti-Corruption Agency (Centralne Parliament in the form of a members’ bill.
between 60% and 80% of costs. For Biuro Anti-Korupcyjne – CBA) released This meant that the statutory requirement
example, in 2006–2007 the daily rate paid tapes of a conversation it had secretly for consultation with social organisations
by the NFZ for a person/day in a psychi- recorded earlier in the year, between a in the field of health care did not apply.
atric ward stood at PLN78 and 84, Most of these organisations were against
Civic Platform parliamentarian, Beata
respectively, while in the Lubiąż hospital the compulsory commercialisation – and
Sawicka, and a CBA official posing as a
the average cost of a person/day was hence privatisation – of hospitals, and had
businessman. The tapes, apparently indi-
PLN125.11 and 145.5. This resulted in indicated this at a meeting with the Pres-
cating corruption at the heart of hospital
losses of PLN1.55 million in 2005, ident.13 A presidential bid to hold a
privatisation, caused a furore. Prime Min-
PLN2.41 million in 2006, and PLN973,700 referendum on hospital privatisation was
ister Jarosław Kaczyński described the
in the first half of 2007.12 overruled. This idea had had widespread
affair as ‘a gigantic plan to rob Poland, and
support – a survey commissioned by
After 2005, the structure of hospital to rob Polish patients’, the former Pres-
Rzeczpospolita had found 71% of respon-
indebtedness significantly changed. ident Aleksander Kwaśniewski criticised
dents to be in favour of one.14
Unpaid wages to employees which repre- the use of the CBA during the election
sented about 16% of debt at the end of campaign, and Sawicka was expelled from In October 2008, the bill was accepted by
2005, were reduced to a residual 3% by the her Party on the spot. Nevertheless, the the Polish Senate. The health workers’
unions continued to argue that commer- until 2011, when the state budget may be [Findings from the Monitoring of
cialisation meant an open door to in better health.19 What will happen Psychiatric Care, with an Emphasis on
privatisation, saying that it would bring a between now and then is, however, In-patient Care]. Wrocław: NIK,
deterioration of living conditions both for uncertain to say the least. Delegatura We Wrocławiu, 2008.
workers and for patients, leading to further 13. Cichocka E. Bez Referendum w
social divisions and worse access to health Sprawie Prywatyzacji Szpitali [Without a
care for the poor.15 Approximately one REFERENCES
referendum on hospital privatisation]
month later, President Lech Kaczyński of 1. Kuszewski K, Gericke C. Poland. Gazeta Wyborcza 29 October 2008.
the opposing PiS Party used his powers to Health Systems in Transition. Copenhagen:
veto the bill. The consequence was the 14. Dziennik Polski. O Prywatyzację
World Health Organization Regional
introduction by the government of what Szpitali Zapytajmy Lud [Let’s ask the
Office for Europe, 2005.
has come to be known as ‘Plan B’ for hos- people about hospital privatisation].
pital privatisation, which took an 2. Watson P. Unequalizing citizenship: The Dziennik Polski 10 October 2008.
extra-legislative route. politics of health care change in Poland. Available at: http://www.dziennik.pl/
Sociology 2006;40(6):1079–96. wydarzenia/article249642/O_
The economic crisis 3. Piński J. Skok na Szpitale: Rozmowa z prywatyzacje_szpitali_zapytajmy_lud.html
Health policy in Poland entered a new Mariuszem Lapińskim, Byłym Ministrem 15. Polskie Radio. Związkowscy Apelują
phase with the financial crisis of 2008. Zdrowia [Hospital raid: interview with do Prezydenta o Zawetowanie Ustaw
Increasing unemployment and falling Mariusz Lapinski, former Minister of Zdrowotnych [Unions call on President to
levels of pay has meant that in 2009, NFZ Health]. Wprost 30 November 2008:38–39. veto health laws]. Polskie Radio 24
revenue fell below the level assumed in its 4. Ministerstwo Zdrowia. Raport: November 2008. Available at:
budget for the first time in five years.16 At Finansowanie Ochrony Zdrowia w Polsce – http://www.polskieradio.pl/iar/wiado
the same time, a fall in the value of the cur- Zielona Ksiega II [Report: Financing mosci/artykul76723.html
rency has translated into higher costs to Health Care in Poland – The Green Book 16. Szparkowska S. Kryzys Dotarł do NFZ
the NFZ for the health care of Polish II]. Warszawa: Ministerstwo Zdrowia, [The crisis has reached the NFZ].
patients elsewhere in Europe. 2008. Rzeczpospolita 4 September 2009. Available
Hospitals will receive less from the NFZ 5. Watson P. Stress and social change in at: http://www.rp.pl/artykul/288705.html?
than in 2008, since there are no excess Poland. Health and Place 2006;12:372–82. 17. Sroka, J. Doctors protest against
funds from which payment can be made reduced financing of hospital services,
6. CBOS. Opinie o Opiece Zdrowotnej Pod
for patients treated over and above the European Industrial Relations Observatory
Koniec Drugiego Roku Reformy [Opinions
limit defined in contracts – and in some Online 13 February 2009. Available at:
Regarding Health Care at the end of the
cases the limits for 2009 have already been http://www.eurofound.europa.eu/eiro/
Second Year of the Reform]. Warszawa:
reached.17 Banks are even less willing to 2009/01/articles/pl0901049i.htm
CBOS, 2001.
lend to hospitals than before the crisis,
opening the way for debt purchasing firms 7. Polish Social Diagnosis 2009, Table 4.7.4, 18. Kasperska M. Szpitalni Związkowscy
to extend their services to the provision of p.114. Available at: Protestują, Nie Strajkują. [Hospital unions
loans, often at high rates of interest (figures http://www.diagnoza.com/pliki/raporty/ are protesting, not striking] Gazeta
of 15%–20% have been quoted in the Diagnoza_raport_2009.pdf Wyborcza 14 September 2009. Available at:
press). http://miasta.gazeta.pl/wroclaw/1,79448,70
8. Karski J, Koronkiewicz A, Healy J. 37993,Szpitalni_zwiazkowcy_protestuja__
Plan B for hospital privatisation was intro- Health care systems in transition – Poland. nie_strajkuja.html
duced in April 2009, and is scheduled to Copenhagen: World Health Organization
Regional Office for Europe, 1999. 19. Sikora D. Przekształcenie Szpitali
run until 2011. It offers to cover from gov-
w Spółki Wciąż Niepewne [The
ernment funds part of the outstanding 9. Polish Ministry of Health Statistical transformation of hospitals into firms still
debts of hospitals where local authorities Bulletin 2008, Table 4.3, p.45. Available at: uncertain]. Gazeta Prawna 15 September
have agreed to privatise hospitals and have http://www.csioz.gov.pl/pliki/file.php?s= 2009. Available at
put forward an acceptable business plan. cD80 http://praca.gazetaprawna.pl/artykuly/351
However, the sum earmarked for the
10. Banachowicz B. Chair of OZZPiP, 902,przeksztalcenia_szpitali_w_spolki_
purpose has changed from an initial sum of
Statement to the Tripartite Commission for wciaz_niepewne.html
PLN2.7 billion (the total debt of Polish
Social and Economic Affairs, 2004.
health care institutions), to PLN1.38
billion. As of writing no agreement has 11. Chmielewski D. Sekurytyzacja –
been signed between a local authority and Lekarstwo na Szpitalne Długi? [Securiti-
the Ministry of Health within the sation: medicine for hospital debt?]. Służba
framework of this programme, and where Zdrowia March 7–18 2002:19–22.
local authority preparations are underway, 12. Najwyższa Izba Kontroli Informacja
they have provoked health workers’ oWynikach Kontroli Funkcjonowania
protests.18 Opieki Psychiatrycznej, Ze Szczególnym
Although the government has not with- Uwzględnieniem Opieki Stacjonarnej
drawn Plan B, some hold the view that it
would now suit the government to defer
the implementation of the programme Acknowledgement: This article draws on work funded by the British Academy.
Evidence-based
health care
Investigating over-the-counter oral analgesics
There is good evidence supporting the efficacy of standard doses of aspirin,
paracetamol, ibuprofen, naproxen, and diclofenac, all of which are available as
over-the-counter (OTC) medicines in some part of the world. There is no good
evidence for most branded combination products, though it is likely that
additional analgesic effect is produced by codeine.
Background clear ethical considerations in doing this. These

A wide variety of OTC analgesics are available to ethical considerations are answered by using acute
buy, but the amount of high quality information pain situations where the pain is expected to go
about these treatments is limited. We set out to away, and by providing additional analgesia, com-
find evidence for the efficacy of a range of OTC monly called rescue analgesia, if the pain has not
analgesics, available in various parts of the world, diminished after about an hour. This is reasonable,
in standard acute pain trials. Specifically we were because not all participants given an analgesic will
looking for single dose data from four to six hour have significant pain relief. Approximately 18%
trials in post-operative pain models, and reporting of participants given placebo will have significant
standard outcomes. pain relief, and up to 50% may have inadequate
analgesia with active medicines.
Clinical trials measuring the efficacy of analgesics
in acute pain have been standardised over many
years. Trials have to be randomised and double Systematic review and methods
blind. Typically, in the first few hours or days after For references to methods used, refer to Moore A
an operation, patients develop pain that is mod- et al, 2003.1
erate to severe in intensity, and will then be given We searched PubMed, Cochrane Central Library,
the test analgesic or placebo. Pain is measured and our own in-house databases in pain research
using standard pain intensity scales immediately for any double-blind, randomised controlled trials
before the intervention, and then using pain (RCTs) reporting pain relief, pain intensity, or
intensity and pain relief scales over the following patient global evaluation of efficacy as outcomes
four to six hours for shorter acting drugs. Pain over 4–6 hours for single dose analgesic versus
relief of half the maximum possible pain relief or placebo. The search terms used included both
better (at least 50% pain relief) is typically trade names and generic names of the individual
regarded as a clinically useful outcome. For analgesic constituents, including combinations
patients given rescue medication it is usual for no where appropriate. It is not likely that all OTC
additional pain measurements to be made, and for analgesics have been included, since sources for
all subsequent measures to be recorded as initial OTC analgesic names and availability are not easy
pain intensity or baseline (zero) pain relief to come by, and may change from time to time.
(baseline observation carried forward). This OTC analgesic combinations, in particular, may
process ensures that analgesia from the rescue change. The approach, therefore, was to work
medication is not wrongly ascribed to the test with combinations of drugs and doses of the com-
intervention. In some trials the last observation is
binations that appeared to be current in 2009.
carried forward, which gives an inflated response
for the test intervention compared to placebo, but From these trials we extracted outcome data,
the effect has been shown to be negligible over including pain relief measured as a TOTPAR
four to six hours. (total pain relief) at four or six hours, and pain
intensity measured as a SPID (summed pain
Single dose trials in acute pain are commonly
intensity difference) at four or six hours. Mean
short in duration, rarely lasting longer than twelve
TOTPAR or SPID values, for both the active
hours, allowing no reliable conclusions to be
analgesic and placebo, were then converted to
drawn about safety. To show that the analgesic is
%maxTOTPAR or %maxSPID by division into
working it is necessary to use placebo. There are
the calculated maximum value. The proportion of
participants in each treatment group who achieved
Bandolier is an online journal about evidence-based healthcare, written by Oxford at least 50%maxTOTPAR was calculated using
scientists. Articles can be accessed at www.medicine.ox.ac.uk/bandolier/ verified equations, and these proportions con-
This paper was first published in 2009. © Bandolier, 2009. verted into the number of participants achieving
EVIDENCE-INFORMED DECISION MAKING
at least 50%maxTOTPAR by multiplying Figure 1: NNTs (number-needed-to-treat-to-benefit) for all available data
by the total number of participants in the
treatment group. Information on the
Voltarol (502)
number of participants with at least
50%maxTOTPAR for active treatment Solpadeine Plus (61)
and placebo was then used to calculate rel-
Saridon (301)
ative benefit (RB) and number-needed-to-
treat-to-benefit (NNT). Panadol Extra (81)
Panadol (3232)
Results
Nurofen (6475)
One hundred and twenty five RCTs were
retrieved that matched the search criteria. Feminax Ultra (784)
After closer scrutiny, six head-to-head
Cuprofen Plus (167)
comparative trials were excluded due to
lack of a placebo control, and two trials Aspro Clear (679)
were excluded due to lack of analysable Aspirine (371)
data. The remaining 117 trials were ran-
0 2 4 6 8 10 12 14 16 18
domised, double blind and placebo
NNT for at least 50% pain relief (4–6 hours)
controlled and were included in the
efficacy analysis. The studies involved a
mixture of dental pain and episiotomy Figure 2: NNTs (number-needed-to-treat-to-benefit) for dental studies only
pain.
The overall standard and quantity of data
Voltarol (398)
available was poor, particularly for studies
specifically using the trade name OTC Solpadeine Plus (61)
analgesics. To compensate for this we have
Saridon (301)
included data on the equivalent dose
generic named analgesics and their combi- Panadol Extra (81)
nations. For some of the test analgesics
(Anadin Extra, Askit, Codis, Dispirin, Panadol (2171)
Dispirin Extra, Panadeine 15, Paracodol, Nurofen (5428)
Paramol, Pentalgin H, Sedalgin-neo, Sol-
padeine Max) no useable data could be Feminax Ultra (402)
found. In many cases, particularly those Aspro Clear (345)
combination analgesics including codeine,
this was due to differences in the doses of Aspirine (141)
the constituent analgesics used in the 0 2 4 6 8 10 12 14 16 18
available trials as compared with the OTC NNT for at least 50% pain relief (4–6 hours)
versions. In general, OTC containing
codeine tended to use significantly lower
doses of codeine and higher doses of other Comment
constituents; presumably to minimise There are two main issues when looking at ibuprofen from trials in which they have
codeine-related side effects. Information the evidence of acute pain efficacy of OTC been used as active comparators than trials
on combinations of paracetamol and analgesics. The first is the dearth of evi- in which they themselves have been
ibuprofen is included since these newer dence in the public domain for some of tested.3
combinations are likely to appear as OTC these products. The second is what we are
The dearth of evidence is not, therefore,
analgesics in several parts of the world. able to make of what evidence we have.
surprising. It is, however, frustrating. For
Table 1 gives information about the several OTC analgesics we have no reliable
Dearth of evidence
included studies. Table 2 summarises data data, and for others the data available are
Most of the OTC analgesics, including
available for each of the analgesics along inadequate – leading to very wide confi-
combination analgesics, were developed
with its calculated relative benefit and dence intervals in Figures 1 and 2. This is a
decades ago, as long ago as the 1950s, in
number-needed-to-treat-to-benefit. Table shame, because OTC analgesics, properly
times when trials were performed for reg-
3 shows a sub-analysis of only those trials used, are effective for many people.
istration purposes. Publication was
involving dental pain.
infrequent. A good example is a review of It is also the case that the case for analgesic
To summarise the findings of our investi- 30 trials involving about 10,000 patients combinations can be developed using evi-
gation we produced comparative figures examining the analgesic efficacy of caffeine dence from closely related studies. A case
(Figures 1 and 2 for all data and just dental in combination with analgesics published in point is the combination of paracetamol
studies, respectively) showing the NNTs in JAMA in 1984.2 Most of the data was and codeine, where relatively small
and their 95% confidence intervals for unpublished then, and has remained amounts of information for some dose
each analgesic where calculable. unpublished subsequently. We know more combinations are bolstered with evidence
about OTC drugs like paracetamol and from other dose combinations.4
Table 1: Details of available data
Drug Details of available data References of included studies

Anadin Extra We found no trials comparing Anadin Extra (or a generic combination analgesic containing N/A
paracetamol, aspirin and caffeine in similar doses) to placebo
Askit We found no trials comparing Askit (or a generic combination analgesic containing aspirin, N/A
caffeine and aloxiprin in similar doses) to placebo
Aspirine We found two trials comparing a generic combination of aspirin and caffeine (ASA 650mg/ Forbes JA. Pharmacotherapy
caffeine 65mg in Forbes et al. and ASA 800mg/caffeine 65mg in Rubin et al.) against placebo. 1990;10(6):387–93
Both trials were relatively small and used different pain types: Forbes et al. (n=141) in dental and
Rubin A. J Int Med Res.
Rubin et al. (n=230) in episiotomy. The results reflect this with Forbes et al. reporting the % of
1984;12(6):338–45
patients achieving 50% pain relief on the active treatment as 27% and on the placebo as 1%;
while Rubin et al. report 86% on the active treatment and 48% on the placebo
Aspro Clear We found seven trials in a Cochrane review of single dose oral aspirin for acute pain (currently Edwards JE. Cochrane Database
undergoing in-house update) comparing aspirin in any formulation (ASA 1000mg) against placebo Syst Rev. 2000;(2):CD002067
Codis We found no trials comparing Codis (or a generic combination analgesic containing aspirin and N/A
codeine in similar doses) to placebo
Cuprofen Plus We found two trials comparing a generic combination of ibuprofen and caffeine (IBU 400mg/ Cater M. Clin Ther.
COD 30mg) against placebo. Both trials reported pain following episiotomy with similar results 1985;7(4):442–47
Norman SL. Clin Ther. 1985;

7(5):549–54
Disprin We found no trials comparing Dispirin (or a generic formulation of aspirin in a similar dose) to N/A
placebo
Disprin Extra We found no trials comparing Dispirin Extra (or a generic combination of aspirin and paracetamol N/A
in similar doses) to placebo
Feminax Ultra We found five trials in an up-to-date Cochrane review of single dose oral naproxen for acute Derry C. Cochrane Database Syst
pain comparing naproxen or naproxen sodium (NAPROX 500mg or NAPROX SODIUM 550mg) Rev. 2009 Jan 21;(1);CD004234
against placebo
Mersyndol We found one trial comparing Mersyndol against placebo. The trial reported pain following Margarone JE. Clin Pharmacol
dental surgery Ther. 1995;58(4):453–58
Nurofen We found 61 trials in an up-to-date Cochrane review of single dose oral ibuprofen for acute pain Derry C. Cochrane Database Syst
comparing a generic formulation of ibuprofen (IBU 400mg) against placebo Rev. 2009 Jul 8;(3):CD001548
Panadeine 15 We found no trials comparing Panadeine 15 (or a generic combination of paracetamol and N/A
Panadol We found 28 trials in an up-to-date Cochrane review of single dose oral paracetamol for acute Toms L. Cochrane Database Syst
pain comparing a generic formulation of paracetamol (PARA 1000mg) against placebo Rev. 2008 Oct 8;(4):CD004602
Panadol Extra We found one trial comparing a generic combination of paracetamol and caffeine Winter L Jr. Current Therapeutic
(PARA 1000mg/CAF 130mg) against placebo. The trial reported pain following dental surgery Research 1983;33(1):115–22
Paracodol We found no trials comparing Paracodol (or a generic combination of paracetamol and codeine N/A
in similar doses) to placebo
Paramol We found no trials comparing Paramol (or a generic combination of paracetamol and N/A
dihydrocodeine tartrate in similar doses) to placebo
Pentalgin H We found no trials comparing Pentalgin H (or a generic combination of naproxen, codeine, N/A
caffeine, dipyrone and phenobarbitol in similar doses) to placebo
Saridon We found one trial comparing Saridon against placebo. The trial reported pain following dental Kiersch TA. Curr Med Res Opin.
surgery 2002;18(1):18–25
Sedalgin-neo We found no trials comparing Sedalgin-neo (or a generic combination of paracetamol, caffeine, N/A
codeine, dipyrone and phenobarbitol in similar doses) to placebo
Solpadeine Max We found no trials comparing Solpadeine Max (or a generic combination of paracetamol and N/A
Solpadeine Plus We found one trial comparing a generic combination of paracetamol, codeine and caffeine (PARA Cooper SA. Anesth Prog.
1000mg/COD 16mg/CAF 30mg) against placebo. The trial reported pain following dental surgery 1986;33(3):139–42
Voltarol We found four trials in an up-to-date Cochrane review of single dose oral diclofenac for acute Derry P. Cochrane Database Syst
pain comparing all generic formulations of diclofenac (DICLO 25mg) against placebo Rev. 2009 Apr 15;(2):CD004768
Table 2: Summary of data available for each analgesic showing calculated relative benefits (RB) and number-needed-to-treat-to-benefits (NNT)
Number of Percentage Percentage RB NNT

Drug Constituents Number of trials
patients with active with control (95% CI) (95% CI)
Anadin Extra Para400 + Asa600 + Caf90 0
Askit Asa530 + Caf110 + Aloxiprin140 0
2 371 65 28 2.3 (1.8–3.0) 2.7 (2.2–3.7)
Aspirine Asa650 + Caf65 Forbes 1990 141 17 0 39.8 (2.4–648) 3.9 (2.7–6.7)
Rubin 1984 230 86 48 1.8 (1.5–2.2) 2.6 (2.0–3.7)
Aspro Clear Asa1000 7 679 43 16 2.6 (2.0–3.5) 3.7 (3.0–5.0)
Codis Asa1000 + Cod base 16 0
Cuprofen Plus Ibu400 + Cod base 20 2 167 55 31 1.8 (1.2–2.6) 4.1 (2.6–10.3)
Disprin Asa900 0
0
Disprin Extra Asa600 + Para400
Margarone 1995 76 21 8 2.7 (0.8–9.3) 7.6
9 784 52 15 3.4 (2.7–4.4) 2.7 (2.3–3.2)

Feminax Ultra Naprox500
Winter 1983 81 48 22 2.2 (1.1–4.2) 3.9 (2.2–18.0)
Para1000 + Cod base15 +

Mersyndol 1 76 21 8 2.7 (0.8–9.3) Not calculated
Doxylamine succinate10
Nurofen Ibu400 61 6475 54 14 4.0 (3.6–4.4) 2.5 (2.4–2.6)
Panadeine 15 Para1000 + Cod base23 0
28 3232 46 18 2.5 (2.2–2.9) 3.6 (3.2–4.0)

Panadol Para1000
Cooper 1986 61 29 4 6.2 (0.9–45.0) 4.2 (2.5–14.2)
Panadol Extra Para1000 + Caf130 1 81 48 22 2.2 (1.1–4.2) 3.9 (2.2–18.0)
Paracodol Para1000 + Cod base13 0
Para1000 + Dihydrocodeine
Paramol 0
tartarate15
Naprox100 + Cod base8 + Caf50 +

Pentalgin H 0
Dipyrone300 + Phenobarbitol15
Para500 + Caf100 +
Saridon 1 301 23 2 9.2 (1.3–64.5) 4.9 (3.6–7.4)
Propifenazone300
0
Para600 + Caf100 + Cod base20 +
Sedalgin-neo Norman 1985 74 53 29 1.8 (1.0–3.3) 4.2 (2.2–48.5)
Cater 1985 93 57 32 1.8 (1.1–2.9) 4.1 (2.3–19.8)
Solpadeine Max Para1000 + Cod base20 0
Solpadeine Plus Para1000 + Caf60 + Cod base13 1 61 29 4 6.2 (0.9–45.0) 4.2 (2.5–14.2)
Voltarol Diclo25 4 502 53 15 3.6 (2.6–5.0) 2.6 (2.2–3.3)
Para = paracetamol, Asa = aspirin, Caf = caffeine, Cod = codeine, Naprox = naproxen, Diclo = diclofenac, Ibu = ibuprofen.
Table 3: Sub-analysis of only those trials involving dental pain
Number of Number of Percentage Percentage

Drug Constituents RB (95% CI) NNT (95% CI)
trials patients with active with control
Anadin Extra Para400 + Asa600 + Caf90 0
Askit Asa530 + Caf110 + Aloxiprin140 0
Aspirine Asa650 + Caf65 1 141 17 0 39.8 (2.4–648) 3.9 (2.7–6.7)
Aspro Clear Asa1000 3 345 32 11 2.9 (1.8–4.8) 4.7 (3.4–7.6)
Codis Asa1000 + Cod base 16 0
Cuprofen Plus Ibu400 + Cod base 20 0
Disprin Asa900 0
Disprin Extra Asa600 + Para400 0
Feminax Ultra Naprox500 5 402 62 7 8.9 (5.3–14.9) 1.8 (1.6–2.1)
Para1000 + Cod base15 +

Mersyndol 1 76 21 8 2.7 (0.8–9.3) Not Calculated
Doxylamine succinate10
Nurofen Ibu400 49 5428 55 12 4.7 (4.2–5.2) 2.3 (2.2–2.4)
Panadeine 15 Para1000 + Cod base23 0
Panadol Para1000 18 2171 40 9 4.4 (3.5–5.5) 3.3 (3.0–3.7)
Panadol Extra Para1000 + Caf130 1 81 48 22 2.2 (1.1–4.2) 3.9 (2.2–18.0)
Paracodol Para1000 + Cod base13 0
Para1000 + Dihydrocodeine
Paramol 0
tartarate15
Naprox100 + Cod base8 + Caf50 +

Pentalgin H 0
Para500 + Caf100 + Propife-

Saridon 1 301 23 2 9.2 (1.3–64.5) 4.9 (3.6–7.4)
nazone300
Para600 + Caf100 + Cod base20 +

Sedalgin-neo 0
Solpadeine Max Para1000 + Cod base20 0
Solpadeine Plus Para1000 + Caf60 + Cod base13 1 61 29 4 6.2 (0.9–45.0) 4.2 (2.5–14.2)
Voltarol Diclo25 3 398 51 11 4.6 (3.1–7.1) 2.5 (2.1–3.2)
Para = paracetamol, Asa = aspirin, Caf = caffeine, Cod = codeine, Naprox = naproxen, Diclo = diclofenac, Ibu = ibuprofen.
What can we make of the evidence we because there is evidence elsewhere (Smith H. Bandolier’s Little Book of Pain. Oxford:
have et al, 20014, for example) that combina- Oxford University Press, 2003.
The best evidence we have is from tions of analgesics can produce very good 2. Laska EM, Sunshine A, Mueller F, Elvers
ibuprofen 400mg (Nurofen), paracetamol results. WB, Siegel C, Rubin A. Caffeine as an
10,000mg (Panadol), naproxen 500mg analgesic adjuvant. Journal of the American
Consumers can make up their own minds
(Feminax Ultra), diclofenac 25mg Medical Association 1984;251(13):1711–18.
whether the expense of branded analgesics
(Voltarol), and aspirin 1,000mg (Aspro), 3. Barden J, Derry S, McQuay HJ, Moore
is worth it compared to the often much
though the evidence is likely not to have RA. Bias from industry trial funding? A
lower cost of unbranded – though that is a
come from testing of any particular framework, a suggested approach, and a
UK view, and certainly analgesics like
product. All of these analgesics have use- negative result. Pain 2006;121(3):207–18.
paracetamol and ibuprofen are available in
fully low NNTs in the range of about 2–4.
quantity and at low cost in the USA. 4. Smith LA, Moore RA, McQuay HJ,
The evidence for combination analgesics is Gavaghan D. Using evidence from differ-
less clear, with predominantly no trials, or ent sources: an example using paracetamol
too few trials and patients available to REFERENCES 1000 mg plus codeine 60 mg. BMC Medical
make any judgement. This is a shame, Research Methodology 2001;1:1.
1. Moore A, Edwards J, Barden J, McQuay
Mythbusters
Myth: Whole-body screening is an effective way to detect hidden cancers
Whole-body screening is promoted as a one- worry and medical complications.6 A good

stop shop for painlessly detecting hidden screening test is sensitive and specific, pro-
cancer and preventing cancer-related deaths. It ducing a low rate of false negatives and false
is big business in the United States.1 In positives. It should also reduce the number of
Canada, private clinics have begun offering deaths from the disease tested for, while not
full-body diagnostic procedures for a fee.2,3 subjecting people to unacceptable harm.7
The tests and procedures are often marketed Generally, recommended cancer screening
to healthy people as a way to scan for hidden tests – for example, a mammogram – meet
abnormalities or cancers, affording people the these criteria. A mammography for women 50
peace of mind that they are in good health.2,3 to 69 years of age may decrease breast cancer
When used in this manner, the evidence shows deaths by up to 30%,8 while a fecal occult
that whole-body cancer screening offers no blood test for individuals 50 to 74 years of age
proven health benefits and that it, in fact, can decrease colon cancer deaths by 15%.9 As
exposes people to a number of unnecessary well, since the introduction of Pap tests more
health risks. than 25 years ago, cervical cancer mortality
has declined by 60%.10
Sound screening is sensitive and specific
In contrast, there is no evidence that whole-
Using Computerised Tomography (CT), Mag-
body screening of healthy people prevents
netic Resonance Imaging (MRI) technology
cancer-related deaths. In fact, evidence shows
or, at times, Positron Emission Tomography
that whole-body screening – which is neither
(PET), whole-body screening involves
scanning the body from different depths and sensitive nor specific – poses a number of
angles to compile an image that can be serious risks to patients, including unnec-
examined for abnormalities. When these tests essary examinations, overexposure to
are used to make, confirm or refine a diagnosis radiation, and high false positive and false neg-
in patients with cancer symptoms, or to ative rates.11–13 Whole-body screening also
monitor patients undergoing cancer treat- increases the rate of over-diagnosis – the diag-
ments, the benefits outweigh the risks.4 nosis of diseases or ailments that would not
Screening to detect abnormalities or possible have caused any problems in a person’s
cancers can lead to one of four outcomes: lifetime or for which therapy is not known to
be effective.14
– normal test result and no cancer (true
negative) Risky business
– normal test result, but an undetected cancer No screening test is free of risks, but some
(false negative) screening procedures are more harmful than
others. It is estimated that whole-body CT
– abnormal test result, but no cancer (false screening, for example, uses 500 to 1,000 times
This issue of Mythbusters is based positive) the radiation levels of a routine chest x-ray.12
on an article written by Kathleen – abnormal test result and actual cancer (true Radiologists have expressed concerns about
Decker, recipient of the 2009 positive).5 exposing patients to this level of radiation,
Mythbusters Award. Kathleen is a given the unproven benefits of whole-body
PhD candidate at the University False positives in particular often lead to a screening and the potentially life-threatening
of Manitoba and a research coor- cascade of additional testing and biopsies, risk in causing radiation-induced cancer.15
dinator for the Manitoba Breast which can bring additional costs to the health Concerns about exposing patients to unnec-
Screening Program at CancerCare care system as well as further risks to the essary radiation have been raised related to
Manitoba in Winnipeg. patient, not the least of which are anxiety, PET scanning, too.5 Although MRI scanning
doesn’t use ionising radiation, it poses its own
Mythbusters are prepared by Knowledge Transfer and Exchange staff at the risks: its magnetic field can pull on or heat up
Canadian Health Services Research Foundation and published only after review by metallic implants such as pacemakers or pins,
a researcher expert on the topic. causing soft-tissue tears or burning.12
The full series is available at www.chsrf.ca/mythbusters/index_e.php. Given the potential risks, assessments of the
This paper was first published in 2009. © CHSRF, 2009. effectiveness of whole-body screening should
A series of essays by the Canadian Health Services
Research Foundation on the evidence behind
healthcare debates
be based on robust evidence. However, for more than 30% of the total costs.21 10. Canadian Cancer Statistics 2006.
there are no randomised controlled trials Toronto: Canadian Cancer Society, 2007.
of whole-body screening and only a Conclusion 11 Cassels A, van Wiltenburg J, Armstrong
handful of retrospective reviews.16–17 Whole-body screening for healthy people W. What’s in a scan? How well are con-
These report that the percentage of offers the promise of early cancer sumers informed about the benefits and
people who had an abnormal test result detection and reduced cancer-related harms related to screening technology (CT
from a full-body scan ranged from 33% deaths. Despite the claims, such screening and PET scans) in Canada? Ottawa: Cana-
to 52%.16–17 This is compared to an has not demonstrated any positive effects dian Centre for Policy Alternatives, 2009.
abnormal rate of 6% for a mammogram18 on life expectancy. Instead, it is tied to 12. Health Canada, Public Health Agency
and 2% for a fecal occult blood test.19 significant risks, costs and anxiety for of Canada. Whole-body screening using
The evidence suggests that whole-body clients, as well as to substantial costs and MRI or CT Technology. It’s Your Health.
screening is neither sensitive nor specific, unnecessary service use on the healthcare Ottawa: Health Canada, 2003. Available at
and that it can lead to a high rate of false system. Cancer screening recommenda- http://tinyurl.com/y9h9cz3
positives and negatives. A study that tions and decisions should be based on 13. Salman RAS, Whiteley WN, Warlow C.
examined the abnormalities arising from reliable data and careful weighing of all of Screening using whole-body magnetic
whole-body screening, for example, the potential benefits and harms. resonance imaging scanning: who wants
found that the overwhelming majority – an incidentaloma? Journal of Medical
up to 97% – were benign and not clini- Screening 2007;14(1):2–4.
cally significant.15 A 2006 study also REFERENCES
14. Modic MT, Obuchowski N.
showed that whole-body PET screening 1. Scandirectory.com. Updated 12 July Whole-body CT screening for cancer and
alone failed to spot 29% of cancers 2007; Accessed 8 July 2009. coronary disease: does it pass the test?
detected in a population of over 3,400 2. EcuMedical. What you need to know Cleveland Clinic Journal of Medicine
healthy individuals who were subjected about full body scans. 2004;71(1):47–56.
to multiple screening procedures; in other 15. Ghotbi N at al. Cancer screening with
3. Canada Diagnostic Centres. How can
words, it also had a significant rate of whole-body PET/CT for healthy
preventative health scans help me?
false negatives, indicating that those who asymptomatic people in Japan:
http://www.canadadiagnostics.ca/private/
have received a whole-body scan should preventative-health-scans.php re-evaluation of its test validity and
not forego recommended screening radiation exposure. Asian Pacific Journal
tests.19 The same study found that more 4. Schmidt GP et al. Whole-body magnetic of Cancer Prevention 2007;8:93–97.
conventional screening tests, like resonance imaging and positron emission
tomography-computed tomography in 16. Furtado CD et al. Whole-body CT
endoscopy, were successful in leading to screening: spectrum of findings and
oncology. Magnetic Resonance Imaging
correct cancer diagnoses.19 A number of recommendations in 1192 patients.
2007;18(3):193–202.
false positives were also reported in a Radiology 2005;237:385–94.
small, pilot, randomised controlled trial 5. Schoder H, Gonen M. Screening for
cancer with PET and PET/CT: Potential 17. Obuchowski N, Modic MT. Total body
on whole-body screening of healthy sub-
and limitations. Journal of Nuclear screening: predicting actionable findings.
jects conducted in the US: 64% of the
Medicine 2007;48(1):4–18s. Academic Radiology 2006;13:480–85.
experimental (screened) group partici-
pants had an abnormal test result, but 6. Rosenfeld EL, Duggan AE. Colorectal 18. Decker K, Harrison M, Watters K.
there were no confirmed cases of cancer.20 cancer screening; ensuring benefits Manitoba Breast Screening Program
In addition, the medical costs were more outweigh the risks. Medical Journal of Biennial Report 2004–2006. Winnipeg,
Australia 2008; 188(4):196–97. Manitoba: Cancer Care Manitoba, 2007.
than twice as high for participants in the
experimental group than for those in the 7. Wilson JM, Jungner YG. Principles and 19. Ono K et al. The detection rates and tu-
control (non-screened) group. practice of mass screening for disease. mor clinical/pathological stages of whole-
Boletín de la Oficina Sanitaria body FDG-PET cancer screening. Annals
The cost-effectiveness of whole-body of Nuclear Medicine 2006;21(1):65–72.
screening has been further called into Panamericana 1968; 65:281–393.
question by a 2006 analysis of the 8. Gotzsche PC, Nielsen M. Screening for 20. Obuchowski NA et al. Total-body
breast cancer with mammography. screening: preliminary results of a pilot
potential effect of whole-body screening
Cochrane Database of Systematic Reviews randomised controlled trial. Journal of the
on health and health care costs, which
2006;4:1–61. American College of Radiology
estimated that providing full-body
2007;4:604–11.
screening to a group of 500,000 healthy 9. Hewitson P et al. Screening for
people at age 50, at a cost of $2,513 per colorectal cancer using the faecal occult 21. Beinfeld MT, Wittenberg E, Gazelle
person, would lead to an average gain in blood test, Hemoccult. Cochrane Database GS. Cost-effectiveness of whole-body CT
life expectancy of only six days in 26.3 screening. Radiology 2005; 234:415–22.
of Systematic Reviews 2007;1(Art. No.:
years.21 False-positive results accounted CD001216):1–25.
NEW PUBLICATIONS
Eurohealth aims to provide information on new publications that may be of in-
terest to readers. Contact Azusa Sato at a.sato@lse.ac.uk if you wish to submit
a publication for potential inclusion in a future issue.
Sixty years of WHO in Europe This publication provides an overview of WHO’s Contents:
activities in the Regional Office for Europe over the
Introduction
last sixty years. The report begins with a look at how
World Health Organization
Copenhagen was chosen as the base for operations, and The road to Copenhagen
then provides a historical analysis of the attributes of
1949–1956: Dr Norman Begg:
each of the five former directors, their major achieve-
the First Regional Director
ments and projects. This information is placed within the
context of changing socioeconomic and health chal- 1956–1966: Dr Paul van de
lenges, particularly in the 1960s. A substantial propor- Calseyde: the Second Regional
tion of the report is dedicated to outlining major events Director
of the past ten years. For example, the Health and Sta-
1966–1985: Dr Leo A. Kaprio:
bility Pact of 1999 and WHO’s increased efforts to con-
the Third Regional Director
tain the impact of humanitarian disasters upon health.
Cases discussed include: avian influenza in Turkey; ab- 1985–2000: Dr Jo E Asvali:
normally cold weather in Tajikistan; lead poisoning in the Fourth Regional Director
Copenhagen: World Health
Kosovo; mass immunisation in Ukraine; and polio erad-
Organization, Regional Office for 2000–2010: Dr Marc Danzon:
ication.
Europe, 2010 the Fifth Regional Director
The report also serves to summarise milestones created
ISBN 978 92 890 1417 5 Epilogue
by WHO European conferences. In addition to the 2008
70 pages WHO Ministerial Conference on Health Systems, six Information sources
others are discussed in terms of goals set and achieved.
Freely available online at:
Important international partnerships and internal
www.euro.who.int/Document/
changes are presented. Additional information pages,
E93312.pdf
references and web links are chronologically provided.
The socioeconomic impact of EHR IMPACT is the last element of an EU commis- Contents:
interoperable electronic health sioned study that comprised nine quantitative and two
Executive summary
records (EHR) and ePrescribing qualitative independent evaluations of good practice
systems in Europe and beyond cases on interoperable electronic health record and Introduction
ePrescribing systems in Europe. The study aimed to
Definitions
improve awareness and provide evidence on the socio-
Alexander Dobrev, Tom Jones, Approach and methodology
economic and financial impact of EHRs. To this end the
Karl Stroetmann, Yvonne Vatter,
report presents a conceptual framework within which Synthesis of outcomes
Kai Peng
practice can be analysed. Study sites include systems
implemented over the last twelve years from all over Eu- Acknowledgements
rope (UK, Switzerland, Bulgaria, Spain, Czech Repub- References
lic, France, Italy), in addition to the USA and Israel.
Cost benefit analysis and sensitivity analysis are used as
the methodological foundation for the report, which
indicates that EHRs are beneficial but need net cash
injections to be effective. In all cases it is shown that
socioeconomic gains outweigh costs and typically take
between four and nine years to produce net returns.
Health care providers shoulder the majority of costs
Brussels: European Commission, but are also the main winners. Crucially, the impor-
DG Information Society & Media, 2009 tance of information sharing – ‘interoperability’ – forms
a vital backbone of EHR and ePrescribing systems, with
54 pages
continuous engagement a necessary precursor to suc-
Freely available online at: cessful implementation. The report provides advice for
www.ehr-impact.eu/ policymakers, with strategic recommendations of note.
WEBwatch Please contact Azusa Sato at
a.sato@lse.ac.uk to suggest web sites for
potential inclusion in future issues.
Spanish EU Presidency January 1, 2010 marked the beginning of Spain’s presidency of the European Union. The Employment,
Social Policy, Health and Consumer Affairs (EPSCO) council site brings together objectives, policies
http://eu2010.es/en/
and external resources. A calendar directs users to search for upcoming events. Links to the main EU
unioneuropea/politicas/empleo/
site and the Spanish presidency in focus are also accessible, including a detailed list of specific health pri-
orities. A search facility for downloads is available for documents, news and key agenda items. The site
is available in Spanish, Catalan, Galician, Basque, English and French.
Health Services Research – Health Services Research-Europe is an European Commission funded consortium, coordinated by the
Europe Netherlands Institute for Health Services Research (NIVEL) and involving four other major health
services research institutes, which aims to identify, evaluate and improve the contribution of health serv-
www.healthservicesresearch.eu
ices research (HSR) to the health policy process both at the national and EU levels. This focuses on five
areas: health (care delivery) systems; health care organisations and professional practices; health tech-
nology assessment; benchmarking & performance indicators; and relationships between research & pol-
icy. One major activity is a forthcoming conference in the Hague on 8–9 April 2010, where the HSR
community and decision makers will meet to set an agenda for European HSR and strengthen the re-
search-policy infrastructure. The website also has a dedicated members-only area and search box. Users
are able to subscribe to a newsletter.
Social Dialogue Social Dialogue offers information on European employment and disability issues. The site is spon-
sored by the European Commission and aims to raise awareness of innovative policies and practices
www.socialdialogue.net/en/
across Europe to support people with disabilities. Information on policies, legislation and affiliated
index.jsp
organisations are listed on the site under five main sections – IT & social dialogue; corporate social
responsibility; lifelong learning; social inclusion and disability, and economic & social change. Recent
news items are outlined on the homepage, whilst a library and project databases allow users to search
for relevant documents. A members’ only area is available. The site is accessible in Greek, English,
French and German.
Health and Environment The Brussels based HEAL aims to raise awareness of how environmental protection improves health.
Alliance (HEAL) It represents sixty-five social and professional organisations across Europe. Issues of particular con-
cern include the environment and health policy; mercury and health; chemicals; pesticides; climate
www.env-health.org/a/2837
change; air quality; public participation and environmental diseases. The website has a dedicated
members’ only area, and resources which include media coverage, book reviews, publications and pho-
tos. Users can sign up for environmental health news and news feeds. Contact details and external links
can be found online.
European Policy Centre The EPC is an independent think tank comprising over four hundred international members which
(EPC) aims to provide policy makers with high quality information on a range of issues including health and
long term care. It organises a series of events, reports of which are subsequently made available on the
www.epc.eu
website. Key publications and some keynote speeches are also available. A calendar allows users to
search for future events.
CALL for InterOPErability, CALLIOPE is a network of collaborating organisations mandated with the planning and implemen-
(CALLIOPE) tation of eHealth. It has representatives from national governments, eHealth competence centres and
eleven EU-level stakeholder organisations of health professionals, patients, health insurers and indus-
www.calliope-network.eu
try. The web site identifies and outlines key priority areas and encourages knowledge sharing and
collaborations amongst stakeholders. Those interested can join Calliope online and consequently
subscribe to newsletters and remain informed of future events. Event reports, newsletters and other ma-
terial are downloadable. There is also a frequently asked question section.
MONITOR
NEWS FROM THE INSTITUTIONS the adverse health impact of en- “play its part by continuing to
vironmental threats in the next focus attention across European
decade. Future work will be Union policies on environmental
European governments adopt based on a new European re- impacts on health.”
plan to reduce environmental gional framework for action, en-
In September 2010, Member
risks to health by 2020 titled “Protecting health in an en-
States will gather in Moscow for
The Fifth Ministerial Conference vironment challenged by climate
the sixtieth session of the WHO
on Environment and Health: change”. The document provides
Regional Committee for Europe
“Protecting children’s health in a a comprehensive roadmap laying
to endorse the outcomes of the
changing environment”, organ- out steps and priorities for coor-
conference through a resolution.
ised by the World Health Organ- dinated international and national
Governments gathered in Parma
ization (WHO) Regional Office action.
also agreed to strengthen political
for Europe and co-hosted by Through the Declaration and coordination between regular
Italy’s Ministry of Health and Commitment to Act, participat- ministerial conferences, and will
Ministry for the Environment, ing governments agreed to imple- now involve ministers directly in
News
Land and Sea took place in ment national programmes to steering the process to ensure that
Parma, Italy on 10–12 March provide equal opportunities to cross-sectoral issues are given the
2010. Focused on protecting chil- each child by 2020 by ensuring highest possible political profile.
dren’s health, the Conference access to safe water and sanita-
aimed to drive Europe’s agenda tion, opportunities for physical More information on the
on emerging environmental activity and a healthy diet, im- conference is available at
health challenges over the next proved air quality and an envi- www.euro.who.int/parma2010
ten years. ronment free of toxic chemicals.
Governments also pledged to EU ministers outline 2020 vision
More than ever, children’s health
place health at the centre of socio- for eHealth
is at risk from a changing envi-
economic development through The eighth Ministerial eHealth
ronment. The health impacts of
increased investment in new tech- Conference, co-organised by the
environmental risk factors – in-
nologies and green jobs. Stefania Spanish Presidency of the Euro-
adequate water and sanitation,
Prestigiacomo, Italian Minister pean Union and the European
unsafe home and recreational en-
for the Environment, Land and Commission, in cooperation with
vironments, lack of spatial plan-
Sea, noted that “environment and the Regional Government of Cat-
ning for physical activity, indoor
health objectives can also serve as alonia and the Foundation Tic-
and outdoor air pollution, and
an engine to boost innovation and Salut, was held in Barcelona on
hazardous chemicals – are ampli-
competitiveness”. 15–18 March 2010. EU ministers
fied by recent developments such
outlined a joint vision and policy
as financial constraints, broader Delegates also underlined that the priorities on how to make
socioeconomic and gender in- health sector, one of the most en- eHealth more accessible, interac-
equalities and more frequent ex- ergy-intensive sectors in all coun- tive and customised to patients
treme climate events. They pose tries, should lead moves to reduce over the next ten years.
new challenges for health systems greenhouse gas emissions in the
to reduce deaths and diseases public sector by rationalising en- Their Declaration called for pol-
through effective environmental ergy use. They also agreed to icy coordination amongst the var-
health interventions. strengthen early-warning surveil- ious areas where eHealth can
lance and preparedness systems have an impact on citizens’
Evidence is growing that climate
for extreme weather events and health, in order to enhance bene-
change is contributing to an in-
disease outbreaks. fits for patients, health care sys-
crease in the frequency of natural
tems and society. It also recog-
disasters, such as heat-waves, “We need a radically new vision
nised the need for stronger
floods and droughts. Since 1990, for European health policy to ad-
synergies with policy areas like
the International Disaster Data- dress the biggest health challenges
competitiveness, research and re-
base (EM-DAT) has recorded of our Region. This Conference
gional development, both at Eu-
more than 1200 natural events in has opened an exciting new chap-
ropean and national levels.
the WHO European Region, after in the way European govern-
fecting over 48 million people and ments work on environment and The importance of eHealth, they
causing more than 112,000 health, helping to push these noted, should be underlined in
Press releases and deaths, at an estimated loss of closely inter-related issues higher the framework of the future EU
other suggested in- more than US$ 241 billion. up the political agenda,” stated 2020 Strategy and the European
formation for future Zsuzsanna Jakab, WHO Re- Digital Agenda. They noted that
inclusion Pledge to reduce health impact gional Director for Europe. In the information and communication
can be emailed to of environmental threats meantime, John Dalli, European technology (ICT) tools for health
the editor All 53 Member States of the Commissioner for Health and should be used to scale up bene-
David McDaid WHO European Region adopted Consumer Policy promised that fits to patients, health care sys-
d.mcdaid@lse.ac.uk a declaration pledging to reduce the European Commission will tems and society. Large scale ac-
MONITOR
tions at European level to link research, in- Employers’ Association (HOSPEEM) – with all relevant safety legislation and the
novation and deployment were therefore European Social partner organisations. It results of the 2008/2009 check will feed
welcomed. The Commission should re- aims to achieve the safest possible working into a follow up project launched by au-
port on progress in this area. The signato- environment for employees in the sector thorities in twelve Member States to train
ries also underlined the importance of in- and protect workers at risk, as well as pa- more inspectors and improve information
volving all stakeholders in the strategic tients; prevent injuries to workers caused for consumers. The outcome of this proj-
planning, validation and implementation by all types of sharp medical objects (in- ect should be available at the end of 2011.
of eHealth. cluding needle sticks); and set up an inte- The authorities are also working with the
grated approach to assessing and prevent- sunbed industry, which is itself developing
The Ministerial Conference is the latest
ing risks as well as for training and training material for service providers such
step in more than two decades of support
informing workers. as tanning studios.
from the European Commission during
which time more than 450 projects, at a More information at www.consilium. More information at
cost of €1 billion, have been funded. Since europa.eu/uedocs/cms_data/docs/ http://ec.europa.eu/consumers/citizen/
2007 the European Commission has been pressdata/en/lsa/113210.pdf my_safety/sunbeds/index_en.htm
supporting eHealth deployment via the
Competitiveness and Innovation Pro- One in seven sunbeds in breach of UV
gramme and over the last year through radiation safety limits
NEWS FROM THE EUROPEAN COURT
the Public Health Programme. Consumers need to be more aware of the
OF JUSTICE
potential risks associated with using
More information on the High-Level
sunbeds according to the results of a mar-
conference and World of Health IT
ket surveillance check of sunbeds and
conference can be accessed at
sunbed services, published on 12 February ECJ Opinion states UK prescribing
www.ehealthweek2010.org/ 2010 by the European Commission. incentives schemes are illegal
On 11 February, the European Court of
New legislation to reduce injuries for In a project led by the Dutch Food and Justice (ECJ) provided an Opinion (C-
health care workers in Europe Consumer Product Safety Authority, mar- 62/09) to the High Court of Justice in
EU Employment and Social Affairs Min- ket surveillance authorities in ten Member England and Wales stating that prescribing
isters on 8 March 2010 adopted a Directive States (Belgium, Cyprus, Czech Republic, incentive schemes operated by Primary
to prevent injuries and infections to health Denmark, Finland, Germany, Hungary, Care Trusts (PCTs) in England were ille-
care workers from sharp objects such as Latvia, the Netherlands and Poland) ex- gal under EU law. In his Opinion, Advo-
needle sticks. This is one of the most seri- amined safety information and advice pro- cate General Nilo Jääskinen stated that
ous health and safety threats in European vided to consumers, the labelling of the schemes have the deliberate and di-
workplaces, estimated to cause one million sunbeds, and the availability of eye pro- rect intention of promoting certain me-
injuries each year. The legislation specifi- tection and ultra-violet (UV) radiation dicinal products within the National
cally addresses one of the priority objec- emitted by sunbeds. Health Service (NHS) at the expense of
tives of the EU’s current strategy for They inspected more than 500 sunbeds at others, and that the schemes therefore
health and safety at work, which aims to over 300 locations (mostly tanning salons amount to promotion. This relates specif-
cut workplace accidents by 25% by 2012. and wellness centres) between September ically to Article 94(1) of European Direc-
2008 and September 2009. Three main tive 2001/83, which covers the provision
The Directive translates into Community
problems were found: UV radiation lim- of human-use medicines, including their
law an agreement negotiated by the Euro-
its for sunbeds were violated in one in advertising and promotion.
pean social partner organisations in the
sector, which employs around 3.5 million seven sunbeds made available at tanning The ECJ Opinion was in response to ac-
people. Speaking at the Council of Minis- services; consumer guidance, including on tion by the Association of the British
ters meeting, László Andor, EU Commis- the hazards of UV radiation or prohibiting Pharmaceutical Industry (ABPI) against
sioner for Employment, Social Affairs and their use by under 18s was not provided; the Medicines and Healthcare Products
Inclusion said that “the health care sector and there were insufficient warnings on Regulatory Agency (MHRA) in the Eng-
is one of the biggest employers in Europe the sunbeds themselves (for example, that lish High Court challenging the practice of
and needles represent a real risk to work- UV radiation may cause injury).
rewarding doctors financially for pre-
ers, both in terms of injuries and increased As a result of their findings the project scribing specific medicines. On 3 July
rates of life-threatening infections like participants recommended that: there 2006, after the ABPI wrote to the MHRA
HIV or hepatitis”. He added that the should be more enforcement at the source expressing concern about the incentive
“new Directive will better protect work- of entry onto the market; further align- schemes being implemented by PCTs, the
ers and their families while reducing the ment of the interpretation of the legal re- MHRA had replied that, in its opinion,
burden of injuries on European health quirements; making consumers better in- Article 94 covered incentive schemes “of a
services.” formed about the hazards of tanning and commercial nature” only. The ABPI dis-
how to avoid them; and to increase the puted this interpretation and sought a re-
The new Directive implements in law a
number of UV radiation checks for a more view of the legality of the MHRA’s posi-
framework agreement on prevention from
representative measure of non-compliance tion in the High Court, which in turn
sharp injuries in the hospital and health
(expected to be higher with more testing). asked the ECJ for an interpretation of Ar-
care sector signed in July 2009 by the Eu-
ticle 94 before it could give judgement.
ropean Public Services Union (EPSU) and Member State authorities are now inten-
the European Hospital and Healthcare sifying their work to ensure compliance Furthermore, the UK had claimed that
MONITOR
the industry group was “not con- be less than 5 % or more than 55 % of the from lower cost prices.
cerned…with preserving the independ- amount of the total tax burden. The rate of
The Court rejected the arguments ad-
ence of doctors or with patient safety, but the proportional excise duty and the
vanced by each Member State in order to
wishes instead to maximise the prescrip- amount of the specific excise duty must be
justify its legislation. Its conclusion had no
tion, and therefore the sale, of branded the same for all cigarettes. The directive
bearing on the Framework Convention
medicinal products manufactured and also provides that the manufacturers and
on Tobacco Control of the World Health
marketed by its members.” However, the importers of manufactured tobacco are to
Organisation (WHO), since it did not im-
Advocate General responded that, in his be free to determine the maximum retail
pose any actual obligation on the Con-
view, “the self-regarding nature of ABPI’s selling price for each of their products
tracting Parties with regard to the price of
motives is legally irrelevant.” Moreover, (Article 9(1)).
tobacco products which would allow
he stated that the UK appears to be the
According to the Commission, the legis- them to act contrary to the provisions of
only Member State with prescribing in-
lation of those three Member States, which the directive. Moreover, the health pro-
centive schemes involving the substitu-
imposes minimum prices corresponding tection objective laid down in Article 30
tion of specific medicines, compared with
to a certain percentage of the average EC can be relied upon only to justify the
other countries that provide other forms
prices of the manufactured tobacco con- quantitative restrictions on imports and
of financial incentive schemes to reduce
cerned (95 % in the case of France, 92.75 exports and the measures having equiva-
pharmaceutical costs.
% for cigarettes and 90 % for fine-cut to- lent effect envisaged by Articles 28 EC
Jääskinen emphasised that his proposed bacco in the case of Austria and 97 % in and 29 EC. However, the Commission
interpretation of the law does not mean the case of Ireland) undermines the free- did not base its action on those provisions
that the NHS is precluded from control- dom of manufacturers and importers to of the EC Treaty.
ling expenditure on medicines. He did determine the maximum retail selling
Finally, the Court considered that Direc-
though suggest that it may need to think prices of their products and, correspond-
tive 95/59 ensures health protection and
about other measures, such as government ingly, free competition. That legislation is
does not prevent the Member States from
price freezes, price reductions and the pro- therefore contrary to the Directive.
combating smoking. It pointed out that
motion of generics. This is not a full judg-
In its judgement the Court recalled, first, fiscal legislation is an important and ef-
ment, although the Opinion of the Advo-
that the directive seeks to ensure that the fective instrument for discouraging con-
cate General will be considered as part of
determination of the tax base of the pro- sumption of tobacco products and, there-
a final decision on the issue, which is ex-
portional excise duty on tobacco prod- fore, for the protection of public health,
pected later this year.
ucts is subject to the same rules in all the since the objective of ensuring that a high
The full text of the Opinion can be Member States but also to maintain the price level is fixed for those products may
accessed via www.curia.europa.eu freedom of manufacturers and importers adequately be attained by increased taxa-
to make effective use of the competitive tion of those products, the excise duty in-
Legislation in France, Austria and advantage resulting from any lower cost creases sooner or later being reflected in an
Ireland fixing minimum retail prices for prices. increase in the retail selling price, without
cigarettes infringes EU law undermining the freedom to determine
It considered that the imposition of a min-
On 4 March the ECJ ruled that legislation prices.
imum retail selling price means that the
in France, Austria and Ireland fixing min-
maximum retail selling price determined The Court added that the prohibition on
imum retail prices for cigarettes infringes
by manufacturers and importers cannot, in fixing minimum prices does not prevent
European Union law. The Commission
any event, be lower than that obligatory Member States from prohibiting the sale
had brought infringement actions before
minimum price, and is therefore capable of of manufactured tobacco at a loss, so long
the Court of Justice against France (C-
undermining competition by preventing as the freedom of manufacturers or im-
197/08), Austria (C-198/08) and Ireland
some of those manufacturers or importers porters to determine the maximum retail
(C-221/08), because it considered that the
from taking advantage of lower cost prices selling prices for their products is not un-
legislation of these Member States con-
so as to offer more attractive retail selling dermined. Those economic actors would
cerning the fixing of minimum prices for
prices. not be able, in that case, to absorb the im-
some manufactured tobacco products,
pact of the taxes on those prices by selling
namely cigarettes and other tobacco prod- The Court therefore held that a system of
their products at a price below the sum of
ucts in the case of France, cigarettes and minimum retail selling prices for tobacco
the cost price and all taxes.
fine-cut tobacco for the rolling of ciga- products cannot be regarded as compatible
rettes in the case of Austria and cigarettes with Article 9(1) of Directive 95/59 unless The full text of the judgements can be
in the case of Ireland, were contrary to Di- it was structured in such a way as to en- accessed via www.curia.europa.eu
rective 95/59 which lays down rules on ex- sure, in any event, that the competitive ad-
cise duty affecting the consumption of vantage which could result for some man-
those products. ufacturers and importers of those products
COUNTRY NEWS
from lower cost prices is not impaired.
The directive obliges Member States to
impose excise duty on cigarettes consisting It concluded that national legislation did
of a proportional element calculated on not make it possible to ensure, in any Swedish regulator proposes
the maximum retail selling price, and a event, that the minimum prices imposed environmental restrictions on
specific element, the amount of which is do not impair the competitive advantage pharmaceutical manufacturing
fixed by reference to cigarettes in the most which could result for some manufactur- In December 2008, the Swedish govern-
popular price category but which may not ers and importers of tobacco products ment commissioned the Swedish Medical
MONITOR
Products Agency (MPA) to identify dif- ronmental certification of production fa- tients in the Czech Republic. It does not
ferent possibilities for strengthening the cilities, with respect to the production of mean that centres will be closed down –
environmental requirements involved in medicines and active pharmaceutical in- instead, some will be selected to play the
the manufacture of pharmaceutical prod- gredients, be introduced to the legislation role of a guarantor of services for espe-
ucts. The MPA was instructed to under- on GMP. This will ensure an environ- cially costly and complex cases. In addi-
take this project in consultation with the mental perspective in the legislation for tion, the centres in the network will play
Swedish Environmental Protection improved cleaning technology at produc- the role of regional coordinators, which
Agency and the Swedish National Chem- tion facilities. have to actively carry out research and
icals Agency, and to focus on both na- apply new knowledge in day to day prac-
In order to better reflect sustainable de-
tional and international perspectives. tice.”
velopment in accordance with the EC
In its final report published at the end of Treaty, the MPA proposes that the current All the cardiovascular centres were care-
2009, the MPA makes proposals for en- EU legislation for the authorisation of me- fully evaluated by the Ministry of Health,
vironmental measures designed to limit dicinal products for humans should be experts from relevant specialisations (i.e.
the adverse environmental effects of changed so that an environmental risk as- cardiology, cardio surgery, angelology,
pharmaceuticals manufacturing. The Re- sessment is also included in the approval. vascular surgery and interventional radi-
port of the Government Commission on ology) in August and September of 2009,
Today, authorities may not include envi-
strengthening environmental require- focusing especially on human resources,
ronmental risk assessment in the risk/ben-
ments in the manufacture of pharmaceu- technical and material equipment, effi-
efit analysis when assessing whether a
tical products and active substances pro- ciency, accreditation of doctors in differ-
poses that environmental protection drug will be approved for marketing au-
ent specialisations, participation in re-
measures be encompassed into market- thorisation. This means that current legis-
search and publications. The decision
ing authorisation legislation at an EU lation does not allow a denial of authori-
about which centres will be included in the
level and into the pharmaceutical reim- sation of medicinal products for humans
network was made in November 2009.
bursement system at a national level. due to any risk of negative environmental
effects. The Swedish government is now The Ministry of Health will support the
It also proposes that an environmental considering the MPA’s proposals and po- essential modernisation of the new centres
risk assessment be included in the EU leg- tential actions. by helping to secure financial resources
islation on the authorisation of pharma- for standard equipment from the struc-
ceutical products. The MPA also proposed The report is available in Swedish, with
tural funds of the European Union as a
that an environmental certification be in- an English summary, at
part of the Integrated Operational Pro-
troduced to the EU legislation on Good http://tinyurl.com/y8unnwm
gramme. The call for proposals was an-
Manufacturing Practice (GMP) and that at nounced on 16 February 2010.
a national level the review of the pharma- Czech Republic: New cardiovascular
ceutical reimbursement system should in- care system introduced Source: http://www.mzcr.cz
clude environmental dimensions The Ministry of Health, together with ex-
perts from professional associations and Slovakia: Reference pricing for
In the 21st century, results from this health insurance companies, recently in- pharmaceuticals
Swedish research indicate that emissions troduced a new cardiovascular care system The reference pricing of pharmaceuticals is
from the manufacture of medicinal prod- in the Czech Republic. As a result, a new considered to be the most important
ucts in India might seriously affect hu- complete network of Complex Cardio- achievement of the Slovak health care sys-
man and animal health, as well as their vascular Centres will be established. They tem in 2009, according to both the Minis-
environment. Pharmaceuticals are found will become the guarantors of care for es- ter of Health, Richard Rasi, and the
in both ground- and drinking water. Cur- pecially costly or complex cases, including Health Policy Institute, an independent
rent studies show that levels of pharma- cardio-surgery, invasive cardiology and health care think tank in Slovakia. The
ceuticals in ‘purified’ waste water are heart transplants. The list of individual economic crisis has significantly affected
above the level of a normal dose of a drug centres and the level of care being pro- the health care sector and deprived health
in a human being. With this background, vided at each will be part of the Ministry insurance companies of important rev-
the discharge of substances from the phar- of Health Bulletin to be published in 2010. enues. Therefore, a 1.2% decline in phar-
maceutical production in the third world maceutical expenditures in the first half
is of serious concern. Cardiovascular diseases are the number
of 2009 (a figure which is likely to remain
one cause of death in the Czech Republic.
A significant part of the current manufac- constant by the end of the year and is the
Every year over 50,000 people die of heart
ture and production of raw materials or same as in 2008) was considered to be a
and circulatory system diseases, which
intermediate products takes place in low major achievement. This is particularly
represent over half of overall mortality.
income countries and many large compa- the case given that drug expenditures in
Minister of Health, Dana Jurásková, said
nies are planning to place even more of Slovakia represent approximately 30% of
that “the concentration of personal and
their production there. National legisla- total health care expenditure. According
technical capacities for these diseases is a
tion is insufficient and these measures are to the Ministry of Finance, savings in 2009
rational step also recommended by the
better met with harmonised EU legisla- totalled €71 million and are projected to
European Union”. The First Deputy Min-
tion, since the level of requirements also be €86 million in 2010. The former figure
ister of Health,, Marek Šnajdr, added that
may affect conditions outside the EU. represents approximately 7% of total drug
“concentrating care into a number of cen-
expenditure in 2008.
The MPA therefore proposes, as a first tres is a key systematic step towards se-
priority, that a requirement for an envi- curing top cardiovascular care for all pa- This accomplishment can be mainly at-
MONITOR
tributed to the Ministry of Finance which form in how health services are delivered print, to help patients with rarer diseases
proposed and implemented three rounds through measures such as minimising access highly innovative new drugs which
of reference pricing for pharmaceuticals. length of stay in hospital and more day are not yet appraised by NICE. The OLS
Slovakia is one of the first countries to case procedures. Alternatives for people, Blueprint, published in July 2009, put for-
have implemented this reference pricing who at present have to be admitted to hos- ward a package of measures to help main-
system. The system compares the six low- pital though emergency departments (ED) tain a competitive life science sector in the
est prices in the European Union, takes for very short hospital stays, will be met UK.
the average, and sets prices in Slovakia ac- through the provision of more services
A Government notice of procurement will
cordingly. “This approach should bring within communities. The emphasis is on a
be published in the Official Journal of the
about important savings which can be continued move towards treatment on a
European Union formally inviting ex-
redirected towards new drugs with proven day case basis where this is clinically safe
pressions of interest for the pilot. Drugs
effectiveness”, said a spokesman from the and in line with international best practice.
included on the Innovation Pass pilot
Ministry of Health. The first three refer-
While the number of people who visit an scheme will be licensed and NICE will
encing rounds have indicated that branded
ED in 2010 is expected to remain con- play a key role in developing and applying
drugs, the top 100 drugs according to con-
stant, the HSE intends to reduce the num- the drug eligibility criteria for the Inno-
sumption, and drugs for cancer and au-
bers who are admitted through EDs by vation Pass. All drugs included on the pi-
toimmune disorders, were the most over-
33,313. This will be achieved by increasing lot will be submitted for NICE appraisal
priced. Referencing will continue to take
access to the specialist skills and senior at the end of the three years.
place twice a year, in April and October.
clinical decision making available in EDs
Sources: www.hpi.sk and www.tasr.sk and in current and planned Medical As- A new expert advisory group will be set
sessment Units, which will mean that peo- up to strengthen existing arrangements for
Ireland: HSE National Service Plan ple do not need to be admitted to hospital commissioning services nationally for ex-
2010 approved unnecessarily. In addition, by increasing tremely rare conditions and to ensure that
The Minister for Health and Children, access to diagnostics for the 10,000 people the system is more transparent and ro-
Mary Harney, on 8 February announced who are admitted to hospital annually bust. The group will have a wide range of
her approval of the Health Service Execu- solely for this purpose, the reduction in expertise to take into account both clinical
tive (HSE) National Service Plan 2010. admissions can be achieved in 2010. and commissioning issues when assessing
The Plan outlines how the HSE plans to all treatments to be funded nationally. It
Speaking about the Service Plan, Professor will replace the National Commissioning
deliver health and personal social services
Brendan Drumm, Chief Executive Office Group in its current form, incorporating
within its 2010 current budget of €14.069
of the HSE, said “our challenge this year the strengthened system.
billion. It projects service activity levels
is to keep on enhancing the quality of the
for 2010 which are broadly in line with Minister O’Brien said that he was ex-
services we provide, which can only be
2009 levels. The Minister said “I welcome tremely pleased to see support for pro-
achieved by improving our effectiveness
the fact that the Plan commits to treating posals that will make a real difference to
and in so doing, reducing costs”.
people in a more effective way with no re- patients with very rare and extremely rare
duction in access to appropriate services. The National Service Plan 2010 can be conditions by helping improve access to
By reducing costs, and reforming the way accessed at www.hse.ie/eng/services/ drugs and services not previously available
services are provided, I am confident the Publications/corporate/NSP2010.html to them. “Exciting, innovative new drugs
HSE will deliver the services people expect which will be included in the Innovation
and continue to improve health outcomes England: Better NHS access to drugs Pass pilot scheme will mean that, with the
for the population.” and treatment for very rare conditions help of NICE, the small number of pa-
Patients with very rare conditions will be tients suffering from rarer diseases will be
The Chairman of the HSE, Liam Downey,
given access to drugs and services not pre- able to get access to a wider range of drugs
has welcomed the Minister’s approval.
viously available on the national health and contribute to the collection of impor-
Despite current resource pressures, other
service (NHS) in England, Junior Health tant data on their impact.”
than the changes to the delivery of hospi-
Minister Mike O’Brien announced on 19
tal based care, the same level of service as More information available at
March 2010.
2009 will be maintained in 2010 within www.dh.gov.uk/en/MediaCentre/
the context of health service reform, a rap- The proposals follow two consultations Pressreleasesarchive/DH_114325
idly changing economic environment and and mean that a small number of drugs
a climate of reducing resources. The and treatments for very rare conditions, England: NHS to provide more services
HSE’s budget allocation for 2010 includes that are not yet appropriate for the Na-
at home
a reduction of over €500 million in respect tional Institute for Health and Clinical
Measures to shape NHS services in Eng-
of pay, this is in line with government pay Excellence (NICE) appraisal process, can
land around individual patients were set
policy outlined in the national budget. now be considered for use in the NHS.
out on 18 February by Health Minister
Acute hospital activity in 2010 will reflect Access to these drugs and services will be Andy Burnham. Transforming how the
the continuing shift from inpatient to day increased through two initiatives that are NHS treats patients with long-term con-
case activity, with an increase in day cases supported by patient groups, NICE, the ditions, by providing more support in
of 6.5% and a targeted reduction in the NHS and industry. The first is the creation people’s homes and local community set-
level of inpatient care provided of 5.6% of a three-year £25 million (€27.8 mil- tings, means that people are able to better
over the 2009 targets. This will be achieved lion) Innovation Pass pilot, as outlined in manage their health and avoid unnecessary
through a combination of continued re- the Office for Life Sciences (OLS) Blue- hospital visits. The Department of Health
MONITOR
have estimated that improvements in the tients, their families and carers. To be of- abortion – which takes effect in June
management of long-term conditions have fered the choice, if clinically appropriate, 2010 – is part of a comprehensive law
already led to efficiencies and savings of to undertake dialysis at home is a major aimed at improving universal access to sex-
£2.1 billion. factor in eliminating frequent travel, max- ual and reproductive health services and
imises time spent with family, and plays an information, especially for young people.
Focussing on providing care at home can
important role in remaining in employ- The new law grants 16- and 17-year-olds
also have a significant impact for social
ment.” abortion access, provided that they notify
care. A report published on 18 February
at least one parent or legal guardian. No-
by the Audit Commission indicated that The Department of Health has also pub-
tification is not required if they believe it
older people who have the opportunity lished a guide for the NHS on developing
would result in “domestic violence,
to be looked after in their own homes if chemotherapy services closer to home.
threats, coercion, abuse, or a situation of
they want, are happier and there are less Giving cancer patients the option of hav-
uprooting or helplessness.” It also allows
costs to the taxpayer. There are already ex- ing chemotherapy at or closer to home
abortion up to 22 weeks if there is a seri-
amples of how being innovative can have where clinically appropriate, can benefit
ous risk to the health of the mother or if
significant outcomes and save money – patient experience and contribute to bet-
the foetus has serious abnormalities.
for instance, for the cost of just one ter outcomes. This follows the recent an-
month’s care package a home can be nouncement that all cancer patients will Spain’s new law also requires that public
equipped with sensors and pagers to help have one to one support within five years. policies related to health, education and
a family look after a relative with demen- social issues promote universal access to
Children and young people who have
tia. Other measures include providing sexual and reproductive health services
acute or long-term conditions, or disabil-
more services at home for children and and programmes – including family plan-
ity or palliative care needs, should be able
young people who have acute or long- ning services – and makes comprehensive
to spend less time in hospital and receive
term conditions or disability or palliative sexuality education mandatory in schools.
care at home or in the community instead.
care needs, and giving more people the Additionally, it requires public health fa-
Providing services for children and young
option to die at home if they wish to. cilities to provide pregnancy-related care
people at home can mean fewer unplanned
and effective family planning methods to
More dialysis at home and chemotherapy visits and shorter stays in hospital, reduc-
all women and their partners.
in the community would mean patients ing distress for children, young people
can benefit from more convenient services and their families. Since 1985 abortion has been decrimi-
that help produce better outcomes and nalised in Spain, but only in matters of
As a next step, the Department of Health
can be more efficient. Around 7,000 pa- rape, or when the health of the child or
will be publishing the final version of the
tients across England could benefit from mother is at risk. Abortions have doubled
National Framework for Children and
home dialysis. Providing haemodialysis at in the past decade in the traditionally Ro-
Young People’s Continuing Care very
home means that patients can tailor their man Catholic country, from nearly 54,000
shortly. This will help in assessing the con-
dialysis sessions around their lifestyle, in 1998 to 115,000 in 2009. The law faces
tinuing health care needs of children and
which can lead to benefits such as better strong opposition from Catholic and pro-
young people, and in considering the be-
blood pressure control, fewer admissions life groups and from the conservative Pop-
spoke packages of care that will be re-
to hospital and less reliance on medication. ular Party, the main political party in the
quired to meet those needs. The Health
As well as benefits to patients, the annual opposition. Popular Party leaders have
Minister also confirmed plans to review
costs of home haemodialysis could be up announced that they will repeal the new
progress on End of Life Care by 2013,
to 25% less than providing dialysis in a law if they win the next election.
with the intention of setting out proposals
hospital or renal centre, and can lead to for a right to choose to die at home in the
long-term savings once initial set-up costs Scotland: Free prescriptions a year
future. The non-governmental organisa-
are recovered. away
tion, Marie Curie Cancer Care, is already
Further progress towards abolishing pre-
Health Minister Andy Burnham said that piloting a range of models through their
scription charges in Scotland will benefit
‘Delivering Choice’ programme.
“the time has come for the NHS to make 600,000 people in low-income households.
a decisive shift in providing more care out More information at www.dh.gov.uk Regulations introduced to Parliament re-
of hospitals and in the patient’s commu- cently will see prescription charges fall to
nity and home. For too long, services have Spain: New law permits abortion £3 (€3.34) from April 2010, if approved,
been organised to fit the convenience of without restriction up to 14 weeks on the road to full abolition in 2011.
the system. A great NHS will put the con- On 24 February the upper house of the
Around 600,000 adults in households with
venience of the patient first, and move Spanish Parliament voted in favour of leg-
an income of less than £16,000 (€17,800)
services towards them where it is safe to islation permitting abortion without re-
are benefiting from the reductions, with
do so. But care in the home can also striction up to 14 weeks into pregnancy.
hundreds of thousands more on modest
achieve better results and save money.” The Senate approved the law tabled by
incomes also finding prescriptions more
Prime Minister Jose Luis Rodriguez Zap-
Jane Macdonald, President of the British affordable. Since the first reduction in
atero’s Socialist government with 132
Renal Society and Lead Nurse for Renal charges in 2008, sales of Prescription Pre-
votes in favour, 126 against and one ab-
Services at Salford Royal Foundation Payment Certificates bought by people
stention.
NHS Trust said that the need for long with long-term conditions who need med-
term dialysis undertaken either thrice The law had already been approved by the icines over a period of months have soared
weekly or in some cases daily has a signif- lower house of Parliament in December by more than 150%. In the first six
icant impact on the lives of dialysis pa- 2009. The expansion of legal access to months of the 2009/10 financial year
MONITOR
alone, 236,000 were dispensed, compared been set out by Minister of Health, Philip on drugs would be put in force quickly,
to just 93,000 in the same period of Roesler of the junior coalition govern- according to the Süddeutsche Zeitung re-
2007/08. ment partner in 2011, the Free Democratic port. Mandatory discounts and a broad
Party (FDP). Controversially he has pro- comparison of German medication prices
The regulations to further reduce pre-
posed a flat rate contribution to health in- with the international standard would be-
scription charges from £4 to £3 (€4.45 to
surance irrespective of income. The sys- gin next year.
€3.34), which will also see four-month
tem would break the link between health
and twelve-month Prescription Pre-Pay- The government’s commission is due to
costs and labour costs. Keeping control of
ment Certificates fall from £13 (€14.47) present its proposals in the summer, in or-
Germany’s high labour costs has formed a
and £38 (€42.31) to £10 (€11.13) and £28 der that the anticipated reform can take ef-
key part of recent government efforts to
(€31.17) respectively, were introduced to fect from 2011.
bolster the nation’s international eco-
Parliament on 6 January 2010. The Health
nomic competitiveness. More information on the work of the
Committee were expected to vote on the
Commission is available in German at
regulations in February. Under Parlia- Under the plan, the state would also sub-
www.bmg.bund.de/cln_178/nn_1168682
mentary rules, the regulations must re- sidise the contributions made by the less
/DE/Gesundheit/Kommission/
main in Parliament for 40 days, during well off, and anyone wanting more than
kommisssion__node.html?__nnn=true
which time any Member of the Scottish the basic coverage could then top up with
Parliament can lodge a motion suggesting private health insurers. But critics have
Poland: plans for electronic health cards
the proposals are rejected by Parliament. warned that the reforms would mean a
announced
two-class health system with patients cov-
Speaking ahead of her appearance at the In an effort to radically reform and
ered by basic insurance forced to pay for
Health and Sport Committee on 3 Febru- improve the national health system the
extra treatment out of their own resources.
ary 2010, Public Health Minister Shona Polish government is planning to
Robison said “we’re committed to scrap- Combined with tensions over tax cuts, introduce an electronic health man-
ping prescription charges and removing Roesler’s proposals have led to cracks agement system, which it is claimed will
this tax on ill-health, which hits those on emerging in Chancellor Angela Merkel’s facilitate easier access to health care
low incomes hardest. We want our na- conservative-led coalition. Horst Seehofer, services.
tional health service to be restored to its who heads up Merkel’s Christian De-
The main directions for the development
founding principles – free at the point of mocrats’ (CDU) associate party, the
of e-Health have been set out in the
delivery and based on clinical need, not Bavarian-based Christian Social Union
e-Health Strategy for Poland 2009–2015.
ability to pay.” She added that “with Scot- (CSU), has threatened to veto the move to
The e-Health Strategy includes four main
land’s record of ill-health and our ap- replace the existing wages-linked contri-
objectives: facilitation of the access of cit-
palling health inequalities, it’s vital that butions scheme with a flat contribution.
izens to information on health care;
we do all we can to help people get the Despite support for the Roesler reforms
improvement in the effectiveness of elec-
health help they need – not put further fi- emerging from the ranks of Merkel’s
tronic documentation flow; modernis-
nancial hurdles in their way.” CDU, Bavarian CSU Health Minister
ation of the health services demand
Markus Soeder dismissed the proposal for
analysis system; and the establishment of
Germany: Tension over health care a flat-rate contribution as “unfair and un-
an ‘interoperational’ electronic health
reforms in coalition government affordable”.
record.
On 17 March, under the auspices of the
Defending the proposal however, Volker
Federal Health Ministry, the first meeting Starting in 2013, Poland will embark on
Kauder, parliamentary leader of the CDU
took place of the new Government Com- issuing every citizen with an electronic
party, emphasised the need to implement
mission on the Sustainable Financing of health card that will contain information
a health care premium, explaining that this
Health and Social Care. The Commission, about their health condition, medical
was agreed as part of the coalition agree-
which consists of eight government minis- diagnosis and any prescription given. The
ment. German Chancellor Angela Merkel
ters, must put forward proposals on re- medication data will be capable of being
has also provided her support for the
forms to the insurance system at a time read at a pharmacy, thus reducing risks
Health Minister, and has urged the coali-
when the country must contend with ever arising from the difficulty of reading a
tion to put an end to the futile bickering
increasing costs and, according to the Ger- doctor’s handwriting. A draft law on
and feuding, and to allow the govern-
man Federal Insurance Office, an esti- information systems in health care is
ment’s commission time to carry out its
mated €15 billion deficit in funding by being prepared. It will constitute the basis
role.
2011. Overall German health care costs of a stable information system and help
are estimated to be some €250 billion per Other mooted reforms include a plan that clarify issues related to collecting, pro-
annum. pharmaceutical companies should negoti- cessing and using information.
ate prices for pharmaceuticals with the
Germany’s health care system instituted a The new system is expected by the gov-
health insurance funds. This the Minister
new universal premium in January 2009. ernment to yield savings of about 4 billion
contends could reduce the costs of phar-
Set at 15.5% of an individual’s gross pay, zloty (approx. €1 billion) on an annual
maceutical expenditure by €2 billion per
it has turned out to be insufficient to basis. They claim it will eliminate phe-
annum. The German daily newspaper
maintain the budgets of the country’s nomena of identity fraud. The reforms are
Süddeutsche Zeitung also ran a story on
statutory insurers. Many have begun put- expected to cost 800 million zloty
20 March, suggesting that the government
ting extra fees on subscribers. (approx. €197 million), 85% of which
may impose a three year freeze on the
will be financed with EU support.
Major proposals for reform have now price of pharmaceuticals. The price freeze
News in Brief
Former WHO Regional Director for Europe. She urged governments to “rig- Health. Building on the achievements
Europe Dr Jo E. Asvall dies orously implement the four basic com- made by the previous Road Map initia-
It was announced with great sadness ponents of cancer control – prevention, tive between 2005 to 2010, the focus of
that Dr Jo Eirik Asvall, the WHO early detection, diagnosis and treatment, the new Map is on continuous high-
Regional Director for Europe from 1985 and palliative care.” quality delivery of the Agency’s core
to 2000, died on 10 February 2010. Born business in an increasingly complex reg-
More information on World Cancer Day
in Norway in 1931, his time as Regional ulatory and scientific environment. In
at www.worldcancercampaign.org/
Director was spent promoting and addition, the document proposes three
implementing the Health for All priority areas – addressing public health,
European Quality of Life Survey:
strategy in the Region. This called for a facilitating access to medicines, and opti-
Subjective well-being in Europe
fundamental change in countries’ health mising the safe use of medicine – for
Drawing on findings from the second
development and outlined four main future actions to strengthen the
European Quality of Life Survey carried
areas of concern: lifestyles, risk factors Agency’s role in protecting and pro-
out by the European Foundation for the
affecting health and the environment, moting human and animal health in the
Improvement of Living and Working
the reorientation of health care systems European Union. Comments on Road
Conditions in 2007, a new report
and the political, management, techno- Map should be sent to the Agency by 30
explores factors that give rise to a feeling
logical, human resources, research and April 2010.
of satisfaction with one’s life and how
other support necessary to bring about More information on the Road Map and
these vary from country to country.
the desired changes in the first three consultation at www.ema.europa.eu/
areas. Written by Dorothy Watson, Florian
htms/general/direct/roadmap/
Pichler and Claire Wallace, the report
Remaining active during his retirement, roadmapintro.htm
looks at different aspects of an indi-
his last public engagement was at the
vidual’s life – such as income, age,
WHO Regional Office for Europe in Snapshot on the health of women
employment, marital status and health –
January 2010. “WHO was his life, his A new report prepared for the European
and their impact on quality of life. In
world, his passion. He was a true leader Commission by the Faculty of Medicine
doing so it gives a wide-ranging picture
in European health policy and public Carl Gustav Carus, the Research Asso-
of the diverse social realities in Europe
health. We owe him so much,” said ciation Public Health Saxony and
today.
WHO Regional Director for Europe, Saxony-Anhalt, the Technische Univer-
Zsuzsanna Jakab. Dr Asvall is survived The report is available at sität Dresden, Germany, provides a
by his wife, Kirsten Staehr Johansen. http://www.eurofound.europa.eu/ snapshot of the health of women across
pubdocs/2009/108/en/1/EF09108EN.pdf the EU and some additional countries in
Tributes can be sent by email to
the European Economic Area.
condolences@euro.who.int
Scotland: Alcohol abuse costs every
Key findings include the recognition
taxpayer £900 a year
Up to 40% of cancer cases could be that breast cancer remains the most
A new report, commissioned by the
prevented, says WHO common form of cancer and cancer-
Scottish Government and authored by a
Marking World Cancer Day on 4 Feb- related death amongst women. Depres-
team from the University of York, has
ruary 2010, the WHO Regional Office sion, Alzheimer’s Disease, arthritis,
revealed that alcohol misuse could be
for Europe highlighted the importance osteoporosis and diabetes are also of
costing Scottish taxpayers up to £4.6 bil-
that changes in lifestyle and improved concern. The report concluded that,
lion a year in costs to health and social
prevention and screening policies can despite much work in recent years, not
welfare services. The report indicates
have in preventing up to 40% of all enough reliable and relevant data is
that crime-related costs resulting from
cancer cases. available by gender. It recommended
alcohol misuse can be as much as £727.1
more investment in the implementation
It was noted that people can signifi- million, while the human costs caused
of standardised gender-specific data col-
cantly reduce their cancer risk by by suffering through premature death
lection across the EU.
avoiding risk factors (such as tobacco were estimated to be £1.46 billion.
use, heavy alcohol consumption, exces- The report is available at
The report is available at
sive sun exposure and obesity) and http://ec.europa.eu/health/population_
www.scotland.gov.uk/Resource/Doc/297
adopting healthier lifestyles. Moreover, groups/docs/women_report_en.pdf
819/0092744.pdf
as cancer incidence rates continue to
rise, governments have a crucial role in
European Medicines Agency
raising awareness and putting in place
consultation
comprehensive early detection measures. Additional materials supplied by
The European Medicines Agency is
“Well-conceived, effective national engaged in a public consultation on its EuroHealthNet
cancer control programmes are essential future strategic vision, set out in the 6 Philippe Le Bon, Brussels.
to fight cancer and to improve the lives document The European Medicines Tel: + 32 2 235 03 20
of cancer patients,” said Zsuzsanna Agency Road Map to 2015: The Agency's Fax: + 32 2 235 03 39
Jakab, WHO Regional Director for contribution to Science, Medicines, Email: c.needle@eurohealthnet.eu
eurohealth Vol 15 No 4 48
Eurohealth is a quarterly
publication that provides
a forum for researchers,
experts and policy makers
to express their views on
health policy issues and so
contribute to a constructive
debate on health policy in
Europe
European
on Health Systems and Policies
ISSN 1356-1030

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Eurohealth

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

Periodic health examination:

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

Comparative clinical effectiveness, drug development and regulatory policy

Investment in more upstream measures to tackle the EDITORIAL BOARD:

Eurohealth an article from the new World Health DESIGN EDITOR:

© LSE Health 2010. No part of this publication may be copied,

Design and Production: Westminster European

Building a healthier Europe Vittorio Bertele’ is Head, Regulatory

Martin Knapp is Professor of Social

28 Hospital privatisation in Poland Lukas Pfister is Executive Director

Egle Sumskiene is based at the Social

40 Web Watch Peggy Watson is at the Homerton

Building a healthier, safer,

Silvio Garattini and Vittorio Bertele’

pean Parliament and Council of 12 Decem-

Lukas Pfister and Frank DeFelice

Social Care: a new initiative in

Martin Knapp and Angela Mehta

Child and adolescent mental

Dainius Puras and Egle Sumskiene

Periodic Health Examination –

Summary: The development of the periodic health examination (PHE) is outlined

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

The EU School Fruit Scheme:

Felix Mittermayer and Robert Pederson

Summary: Public Health is often considered as a European Union (EU) policy,

Policy development and

Key words: implementation, National Service Framework, older people,

digests are disseminated across Wales,

Standard 4 Challenging dependency The circular relationship between re-

Are regulations of community

Keywords: pharmacies, Europe, regulation, competition

and competitiveness of our health care

REFERENCES Peggy Watson

Background clear ethical considerations in doing this. These

Table 1: Details of available data

Drug Details of available data References of included studies

Norman SL. Clin Ther. 1985;

Number of Percentage Percentage RB NNT

Anadin Extra Para400 + Asa600 + Caf90 0

Askit Asa530 + Caf110 + Aloxiprin140 0

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

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

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

Codis Asa1000 + Cod base 16 0

9 784 52 15 3.4 (2.7–4.4) 2.7 (2.3–3.2)

Para1000 + Cod base15 +

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

Panadeine 15 Para1000 + Cod base23 0

28 3232 46 18 2.5 (2.2–2.9) 3.6 (3.2–4.0)

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

Paracodol Para1000 + Cod base13 0

Naprox100 + Cod base8 + Caf50 +

Solpadeine Max Para1000 + Cod base20 0

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

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

Number of Number of Percentage Percentage

Anadin Extra Para400 + Asa600 + Caf90 0