Quarterly of the European Observatory on Health Systems and Policies EUROHEALTH European incorporating Euro Observer

on Health Systems and Policies RESEARCH • DEBATE • POLICY • NEWS

❚ Parliamentary scrutiny • NHS view: Clinical Trials Directive

› Intersectoral 2012

❚ Interdepartmental units • Medicines innovation |

Governance ❚ Joint budgeting • European reference networks and Health in ❚ Industry engagement • Kazakhstan: health system reform Number 4

| All Policies Volume 18 EUROHEALTH

Quarterly of the European Observatory on Health Systems and Policies 4 rue de l’Autonomie B – 1070 Brussels, Belgium T: +32 2 525 09 35 F: +32 2 525 09 36 http://www.healthobservatory.eu

SENIOR EDITORIAL TEAM David McDaid: +44 20 7955 6381 [email protected] Sherry Merkur: +44 20 7955 6194 [email protected] Anna Maresso: [email protected]

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EDITORIAL ADVISORY BOARD Paul Belcher, Reinhard Busse, Josep Figueras, Walter Holland, Julian Le Grand, Suszy Lessof, Martin McKee, Elias Mossialos, Richard B. Saltman, Willy Palm

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Published by the European Observatory on Health Systems and Policies

Eurohealth is a quarterly publication that provides a forum for researchers, experts and policymakers to express their views on health policy issues and so contribute to a constructive debate in Europe and beyond.

The views expressed in Eurohealth are those of the authors alone and not necessarily those of the European Observatory on Health Systems and Policies or any of its partners.

The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Regional Office for Europe, the Governments of Belgium, Finland, 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), London School of Economics and Political Science and the London School of Hygiene & Tropical Medicine.

© WHO on behalf of European Observatory on Health Systems and Policies 2012. No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior permission.

Design and Production: Steve Still

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List of Contributors Jim Attridge w Visiting Research Fellow at The Business School, Imperial College, EDITORS’ COMMENT London, United Kingdom. Maggie Davies w Executive Director 2 at the Health Action Partnership International, London, United Kingdom. Ray Earwicker w Senior Policy Manager at the Health Inequalities Unit, Eurohealth Observer Department of Health, United Kingdom. Scott Greer w Associate Professor at the School of Public Health, University INTERSECTORAL GOVERNANCE FOR HEALTH IN ALL of Michigan, Ann Arbor, USA. 3 POLICIES – Matthias Wismar, David McQueen, Vivian Lin, Catherine M Jones w Programme Director at the International Union Catherine M Jones and Maggie Davies for Health Promotion and Education, Paris, France. THE ROLE OF PARLIAMENTARY SCRUTINY IN PROMOTING Marina Karanikolos w Researcher at the 8 HIAP – Ray Earwicker European Observatory of Health Systems and Policies, London, United Kingdom. INTERSECTORAL PROBLEM SOLVING BY Alexandr Katsaga w Freelance international consultant. INTERDEPARTMENTAL UNITS AND COMMITTEES – 11 Monika Kosi´nska w Secretary General Scott Greer and Anna Maresso of the European Public Health Alliance, Brussels, Belgium. CAN JOINT BUDGETING FACILITATE INTERSECTORAL Maksut Kulzhanov w Director General of the Republican Centre for Health 14 ACTION? – David McDaid Development and President of the National Health Chamber, Kazakstan. ENGAGING INDUSTRY IN INTERSECTORAL STRUCTURES – Vivian Lin w Professor and Chair of 17 Monika Kosińska and Leonardo Palumbo Public Health at the School of Public Health and Human Biosciences, La Trobe University, Melbourne, Australia. Anna Maresso w Research Officer, European Observatory on Health Systems Eurohealth International and Policies and LSE Health, London School of Economics and Political Science, United Kingdom. REVISING THE CLINICAL TRIALS DIRECTIVE: A VIEW FROM David McDaid w Senior Research Fellow CONTENTS 21 THE ENGLISH NATIONAL HEALTH SERVICE – Elisabetta Zanon at LSE Health and Social Care and at the European Observatory on Health Systems and Policies, London School MEDICINES INNOVATION IN SEVERE MENTAL ILLNESS – of Economics and Political Science, 24 THE NEXT INVESTMENT DESERT? – David J. Nutt and United Kingdom. Jim Attridge David McQueen w Consultant in Global Health Promotion and Adjunct Professor at Rollins School of Public Health, DEVELOPING REFERENCE NETWORKS FOR EUROPE: Atlanta, USA. 29 MOVING PATIENTS OR KNOWLEDGE? – Willy Palm, David J. Nutt w Professor of Neuropsychopharmacology, Imperial Irene A. Glinos and Bernd Rechel College, London, United Kingdom and Vice-President of the European Brain Council. Willy Palm w Dissemination Development Eurohealth Systems and Policies Officer at the European Observatory on Heath Systems and Policies, Brussels, Belgium. FINALLY ON TRACK? HEALTH REFORMS Leonardo Palumbo w Policy Coordinator IN KAZAKHSTAN – Alexandr Katsaga, Maksut Kulzhanov, for EU Affairs, European Public Health 33 Alliance, Brussels, Belgium. Marina Karanikolos and Bernd Rechel Bernd Rechel w Researcher at the European Observatory on Health Systems and Policies, London, United Kingdom. Matthias Wismar w Senior Health Policy Eurohealth Monitor Analyst at the European Observatory on Health Systems and Policies, Brussels, Belgium. Quarterly of the European Observatory on Health Systems and Policies NEW PUBLICATIONS Elisabetta Zanon w Director of the EUROHEALTH NHS European Office, Brussels, Belgium. European incorporating Euro Observer on Health Systems and Policies RESEARCH • DEBATE • POLICY • NEWS 36 38 NEWS

❚ Parliamentary scrutiny • NHS view: Clinical Trials Directive

› Intersectoral 2012

❚ Interdepartmental units • Medicines innovation |

Governance ❚ Joint budgeting • European reference networks and Health in ❚ Industry engagement • Kazakhstan: Health system reform Number 4

| All Policies Volume 18 © Iqoncept – Dreamstime.com

Eurohealth incorporating Euro Observer — Vol.18 | No.4 | 2012 2

Since the health of a population is affected by policies and programmes originating beyond the health sector, governments need to employ a strategy that fosters intersectoral action. Health in All Policies (HiAP) is a dual process – it consists of fostering health considerations in other policy areas and taking into account the potential impact of other sectoral policies on the health of the population (the wider social determinants of health) – thus leading to several policy coordination challenges and the need for targeted intersectoral governance mechanisms.

When successfully implemented, HiAP can contribute proposals for new EU legislation and argues that an positively to key aims in promoting public health, improved and streamlined EU regulation on clinical such as ameliorating population health status and trials is essential. Next, Jim Attridge and David Nutt it can also help to diminish health inequalities both approach the topic of innovation in medicines for within countries and throughout the wider region. It severe mental illness. They argue that unless the tide is not surprising therefore, that recently intersectoral of declining investment for these types of medicines governance and HiAP have gained high level attention turns, this area may be the next innovation desert. as a priority of WHO’s Health2020 strategy, while the EU is also promoting it as a strategic policy tool. In this issue’s Eurohealth Systems and Policies section, Alexandr Katsaga and colleagues discuss The first article in the Eurohealth Observer health system reforms in Kazakhstan. Since 2005, section explores key intersectoral structures used two comprehensive national reform programmes by governments, parliaments and the civil service have endeavoured to change health care financing to promote HiAP. The authors also identify which and provision, while improving prevention and quality structures can trigger different governance actions of care. The article then identifies areas of the Kazak or outcomes and summarise some key conditions health system still in need of further development. for their successful implementation. We then present four case study articles which focus on specific Finally, the Eurohealth Monitor section draws intersectoral governance structures – parliamentary attention to three new HiT (Health Systems in committees, inter-departmental units and committees, Transition) profiles for Northern Ireland, Scotland joint budgeting and industry engagement. These and Wales and a new book called Intersectoral articles explore in greater detail how such intersectoral Governance for Health in All Policies, while the mechanisms operate in practice and their strengths news section keeps you up to date on health policy and weaknesses in achieving HiAP objectives. developments across Europe and beyond.

In the Eurohealth International section, Willy Palm We hope that you enjoy this issue and we welcome and colleagues discuss the concept of European your comments and feedback to the editors. reference networks to connect health centres to share knowledge and expertise in diagnosing and treating Sherry Merkur, Editor specific health problems. They contend that under the Anna Maresso, Editor Cross-border Care Directive, such networks can work David McDaid, Editor to improve patient care, but should build on existing practices in Member States to be successful. In her Cite this as: Eurohealth 2012; 18(4). article, Elizabeth Zanon identifies the deficiencies with the current Clinical Trials Directive, analyses the EDITORS’ COMMENTEDITORS’

Eurohealth incorporating Euro Observer — Vol.18 | No.4 | 2012 Eurohealth OBSERVER 3

INTERSECTORAL GOVERNANCE FOR HEALTH IN ALL POLICIES

By: Matthias Wismar, David McQueen, Vivian Lin, Catherine M Jones and Maggie Davies

Summary: Many policies with important consequences for the health of the population are outside the health sector and the remit of ministries of health. If we want to address the health consequences of these policies we need to reach out. To this end, intersectoral governance can help to build bridges and facilitate dialogue and collaboration between other ministries, sectors and stakeholders. This article presents key intersectoral structures used by governments, parliaments and the civil service. It also presents intersectoral structures for managing funding arrangements and engagement beyond government. In addition, we summarise some key conditions for the successful implementation of intersectoral governance.

Keywords: Intersectoral Governance, Health in All Policies, Intersectoral Structures, Governance Actions, Health2020

Introduction A current example of the importance of intersectoral governance in the Intersectoral governance for health in implementation of public health strategies all policies (HiAP) is a policy practice comes from England. The Department in many European countries that aims of Health announced in November 2012 to tackle major health issues by aligning that the cabinet sub-committee on public health and non-health objectives and health (known as the Public Health sub- policies. These may include housing, Committee) will be abolished after only Matthias Wismar is Senior Health consumer protection, environment, land two years in existence. According to Policy Analyst at the European use, transport, taxes, waste management Observatory on Health Systems Whitehall sources, it had proven difficult and working conditions. 1 A great deal and Policies, Brussels, Belgium. to get ministers from departments other David McQueen is Consultant of scientific progress has been made than health to attend the sub-committee in Global Health Promotion and to understand the social causes of ill Adjunct Professor at Rollins meetings and it had met only a few times. 3 health and health inequities and the School of Public Health, Atlanta, The aim of the cabinet sub-committee relationships between policies in these USA. Vivian Lin is Professor was to have an important and leading and Chair of Public Health at areas and population health, and also with role in the implementation of the public the School of Public Health and regard to effective interventions. 2 But Human Biosciences, La Trobe health strategy in England. The central without a particular focus on intersectoral University, Melbourne, Australia. government was aiming to establish a Catherine M Jones is Programme governance structures, actions and framework so that local action in public Director at the International Union contexts, implementation will remain for Health Promotion and Education, health and on the social determinants of sluggish and HiAP will fall short of its Paris, France. Maggie Davies is health could be most effective, and to Executive Director at the Health potential. This is not a marginal issue, it do nationally only the things that need Action Partnership International, is central to the implementation of public London, United Kingdom. to be done at that level. To this end, the health strategies. Email: [email protected] cabinet sub-committee was meant to work

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Table 1: Overview of how intersectoral governance structures may address governance action to support Health in All Policies

Governance actions Evidence support Setting goals & targets Coordination Advocacy Monitoring & evaluation Policy guidance Financial support Providing legal mandate Implementation & management

Government level Cabinet committees and √ √ √ secretariats Parliament level Parliamentary committees √ √ √ √ √ Bureaucratic level /(civil service) Interdepartmental committees √ √ √ √ √ √ and units Mega-ministries and mergers √ √ Managing funding arrangements Joint budgeting √ √ √ Delegated financing √ √ √ √ √ Engagement beyond government Public engagement √ √ √ √ Stakeholder engagement Intersectoral governance structures √ √ √ √ Industry engagement √ √

Source: 4

across multiple departments to address The governance challenges of HiAP European Region adopted a new European the wider determinants of health. The health policy, Health2020 *. The policy The centrality of dialogue and cooperation issues to be tackled were laid out in the posits public health as a major societal across departments to the success of public health strategy and included mental asset and pursues two strategic objectives: HiAP can be illustrated by the example health, tobacco control, obesity, sexual stronger equity and better governance. of alcohol control policy. There are health, pandemic flu preparedness, health At the heart of these intertwined objectives many policies, other than health sector protection and emergency preparedness. 5 is a firm commitment to intersectoral ones, linked to the social determinants In order to fulfil its role, the membership governance using a variety of structures. 6 of alcohol consumption, and as such of the cabinet sub-committee was they provide multiple entry points for an composed in a truly intersectoral manner. What are those intersectoral structures? alcohol control policy. However, most It was chaired by the then Secretary of What intersectoral action can they of the entry points are within the remit State for Health and composed of nineteen facilitate and under what circumstances of the ministries responsible for taxes, cabinet ministers and junior ministers, and for what issues do they work best? retail, transport, education, economic including those for Employment, These questions are raised in the four development, criminal justice and social Energy and Climate Change, Families, case studies included in this issue of welfare. These ministries may pursue Decentralisation, Agriculture and Food, Eurohealth. They deal with parliamentary different objectives: they want to stimulate the Treasury, Home Office, Equalities, committees, inter-departmental units economic activity; enhance mobility; or Transport, Sport and the Olympics. and committees, joint budgeting and provide security. Some of these objectives The chief medical officer could also be industry engagement. These case studies may be conducive to the aim of curbing invited as required. are abridged versions of longer chapters alcohol consumption, whereas others developed for a recently published study, are indifferent or even detrimental. Public health doctors, practitioners and which has dealt with nine intersectoral Without a strong intersectoral governance activists have expressed their dismay at the governance structures. 4 As in the study, structure ensuring common orientation scrapping of the cabinet sub-committee. here we use a matrix as a conceptual and implementation across departments, Concerns have been voiced that this could framework to understand which public health strategies will make be a U-turn in the government’s pledge limited progress. to make public health a priority. Unless the sub-committee is replaced by another Despite occasional political fluctuations, well or better functioning intersectoral * Moreover, the 8th Global Conference on Health Promotion, there is a high level of sustained interest in governance structure, a devoted high- to be held in Helsinki in 2013, and co-organised by WHO and tackling the social determinants of health. the Finnish Ministry of Social Affairs and Health, will focus on level mechanism for cross-departmental In September 2012, the Member States of HiAP. In support of this event and under the leadership of the dialogue and collaboration will be absent. the World Health Organization (WHO) Finnish Ministry, a new study on implementing HiAP will be published. See: http://www.hiap2013.com/ for details.

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governance structures can trigger different of literature on how these committees foundation in Germany were scrapped, governance actions (see Table 1). We may be run, including appropriate after it failed twice to secure support discuss each structure in turn. terms of reference, the adequate level of in parliament. Some of the active seniority and the suitable frequency for foundations are co-financed from tax meetings. While this technical view is revenues, sin taxes or health insurance indispensable when running intersectoral contributions, and they can operate as Without committees, it only tells part of the matching-fund financing projects to a story. Intersectoral committees are often certain percentage. Often criticised as strong derided and unpopular among their institutional duplications that undermine members, and they can be ineffective the established health promotion agencies, intersectoral or even used as a mechanism for delay these foundations have in fact been shown or sabotage. They are only operative to raise the amount of health promotion governance, under very specific circumstances; while spending. 9 useful on bureaucratic issues, they cannot public health resolve political ones. They work best for Public consultation is utilised to reach important issues with wide consensus, and out and engage with wider civil society. strategies will worst when this consensus is absent or There are different ways of doing this. when the issue is not considered a priority For instance, Austria used a public make limited (see case study article in this issues). consultation process to communicate and ‘‘ discuss its new intersectoral public health progress Mega-ministries and ministerial mergers policy. With inputs from almost 4500 are often introduced to enhance the citizens, NGOs and stakeholders, 10 it was Cabinet sub-committees, such as the efficiency and coherence of political considered a relatively well-populated aforementioned cabinet sub-committee on and administrative work in government consultation. In addition, the European public health, either standing or ad hoc, are and administration. One example is Commission, as part of its general decision an intersectoral structure that facilitates the Hungarian Ministry for National making process, submits all legislative and dialogue and collaboration at government Resources which comprises six ministries major proposals to a public consultation level. Health or certain aspects of that may be found in other countries as process. 11 health may be pursued by cabinet sub- individual ministries. Theoretically, the committees that do not bear health in argument seems to be striking, but putting The analysis of stakeholder engagement their name – for instance ‘sustainability theory into practice is more problematic, in the study 4 focuses on health sub-committees’. While it is difficult to and the evidence on increasing conferences organised by national, trace the work of these cabinet committees intersectoral coherence is somewhat federal or regional governments. due to confidentiality issues, emerging unclear. Positive effects, if they take place, Health conferences help to reach out evidence underscores their importance in seem to be very modest and temporary, to a range of stakeholders. Examples setting the context for policy change by making it difficult to assure returns on the can be found in Austria, Germany and developing a common understanding of investment that these mergers represent. 8 France. The best analysed system is issues and solutions. 7 in North Rhine Westphalia, where the Joint budgets are an intersectoral state health conference is mirrored by The role of parliamentary committees structure that can facilitate the funding of health conferences in the municipalities. is analysed in this issue of Eurohealth health-related activities. The pooling takes Evaluation has been favourable, through a case study on the United place within the government and the funds confirming its relevance in agenda setting, Kingdom’s House of Commons Health come from different sources for joint coordination and joint implementation. 12 Select Committee inquiry into health projects. England has utilised this tool, inequalities. It shows that parliament can and Sweden is piloting several projects The last form of intersectoral structure be an important advocate for intersectoral as well. A particularly difficult hurdle is industry engagement. In the case governance and HiAP. As the example is assigning accountability, which can study included in this issue, the authors illustrates, a clear assessment of policy prevent ministries developing joint budgets have analysed the EU Platform on Diet, development and the results of policy- (see case article in this issue). Physical Activity and Health that was set making can inform better governance. up to facilitate joint action between the This parliamentary committee’s work Delegated finance is an intersectoral European Commission, industry and a also went beyond partisan boundaries governance structure that pools monies large number of NGOs. Some countries and prepared the ground for cross-party outside the ministry and therefore allows have mirrored the EU-based activities consensus and policy. for input sources outside of government. by similar national Private-Public Examples include the health promotion Partnerships. The structure is a relatively Intersectoral committees are one of foundations operating in Switzerland, new one and while evaluations are rather the most commonly used intersectoral Austria, Australia and Thailand. However, limited, current experiences highlight governance structures. There is plenty plans for a similar health promotion the challenges of this type of governance

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structure, particularly with regard to made with regard to the conditions under dealing with asymmetries in the resource which these intersectoral governance Box 1: Questions that can help capacities of the participating stakeholders, structures work best. Apart from the policy-makers to choose or managing potential conflicts of interest considerations outlined below, policy- improve the use of intersectoral and reputational risks and engendering makers can ask themselves a series of governance structures mutual trust and real cooperation across questions to help them assess which the sectors represented (see case study intersectoral structure suits their needs in this issue). and has the best chance of working well • What is the general political context (see Box 1). for policy change? What has been tried previously? What other • Political will plays an important external factors are at play HiAP role in the effectiveness of many (i.e. growing public interest, intersectoral structures. Cabinet landmark report released, policy needs to be committees, intersectoral committees disaster /event)? and many other structures do not work • Who is driving the desire for HiAP? firmly embedded or work only with serious limitations if the bureaucracy is left alone without • Is there political will? Or, who else is within general political backing. “on board”? • Most intersectoral governance • Is there strong leadership? policy structures rely on the consideration By whom? and integration of partnerships’ • Which stakeholders are engaged? imperatives and constituents’ interests. If the chemistry between stakeholders does • What are the resourcing This list of intersectoral governance not work, or if stakeholders cannot requirements? How much money, structures is not exhaustive. Some ‘‘ manage to mutually align their interest, if any, is there to contribute? countries, for example, have employed the chances of achieving effective public health ministers to improve • What is the timeframe? Is this a intersectoral governance are slim. The dialogue and collaboration at the cabinet long-term solution, or a one-off? quality of partnerships is essential for table and between different departments. effective governance; this is equally • Is the timing appropriate – for Other countries have introduced strong true with regard to partnerships beyond the political climate, phase of the ministerial linkages that lead to more government where the composition of political cycle and constituency policy consistency and alignment of the partners plays an important role. interest? policy objectives. There are examples For example, industry engagement where health ministries post some staff works better if there is also community in other ministries to ensure that the engagement and participation from health perspective is always taken into in cabinet committees. Similarly, civil society. Functioning partnerships account and that policy developments mergers and mega-ministries require need to deal with power asymmetries, are monitored early. In addition, there the strong leadership of a minister who conflicts of interest and the hidden is health impact assessment, a decision can facilitate change. For stakeholder agendas that come with it. If these support tool that helps to assess the health engagement strong leadership is the asymmetries prevent some partners consequences of pending decisions and single most important condition to from making a vital contribution feeds this information back into the successfully manage tensions and and having their specific interests decision-making process. mediate conflict; the leadership may acknowledged the partnership will come from sources other than the not function. Successful implementation government. • The political importance of the policy • Intersectoral governance structures It is important to note that the governance issue is a key consideration in selecting need to not only respect but also structures discussed above are context- the most appropriate governance actively use the given context to dependent and that institutional settings mechanism. create or benefit from windows of between countries in Europe differ widely. • The immediacy of the problem needs opportunities. In the example of the Interpreting the results of the study also to be taken into account: some of the UK’s parliamentary Health Select requires some caution since the evidence governance structures are more suitable Committee, context assisted its scrutiny base varies widely. For some of the for addressing short to mid-term issues process as it took place at the same intersectoral governance structures there is while others work well with long-term time as the media picked up on several plenty of literature available, while others developments. other influential reports into health were covered for the first time in the form inequalities, helping to promote health of a collection of case studies. Despite • Strong leadership, and if possible from inequalities as a mainstream political these variations, a few observations can be the head of government, is required

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issue. Another example is the creation levels and strong leadership (political, 6 WHO Regional Committee for Europe. Health2020: of mega-ministries that take advantage bureaucratic or both), particularly within a European policy framework supporting action across of perceived policy failures. the broader policy environment where the government and society for health and well-being. Available at: http://www.euro.who.int/__data/ concept of HiAP is less familiar. Fourth, • Resources constitute a critical condition assets/pdf_file/0009/169803/RC62wd09-Eng.pdf HiAP needs to be firmly embedded for effective intersectoral governance 7 within general policy imperatives. Well- Metcalf O, Lavin T. Cabinet committees and because recognising the direct and cabinet secretariats. In: McQueen D, Wismar M, functioning intersectoral governance indirect costs of supporting structures is Lin V, Jones CM, Davies M (Eds). Intersectoral structures must pursue their goals in a way an important commitment to be made to governance for Health in All Policies. Structures, that is tangible and understandable to all actions and experience. (See Reference 4). ensure their effectiveness. partners and that feed into overarching 8 Greer S. Mergers and mega-ministries. In: • There is a range of implementation societal goals. McQueen D, Wismar M, Lin V, Jones CM, Davies M practicalities that need to be taken into (Eds). Intersectoral governance for Health in All Policies. Structures, actions and experience. account when implementing and using References intersectoral governance structures. (See Reference 4). 1 Dahlgren G, Whitehead M. Policies and strategies 9 Schang L, Lin V. Delegated financing. In: to promote social equity in health. Stockholm: McQueen D, Wismar M, Lin V, Jones CM, Davies M Conclusion Institute for Future Studies, 1991. (Eds). Intersectoral governance for Health in All Policies. Structures, actions and experience. 2 Marmot M, Allen J, Bell R, Bloomer E, Goldblatt P. Based on the analyses of these structures (See Reference 4). and the critical conditions identified, WHO European review of social determinants of health and the health divide. The Lancet 10 four issues need to be raised. First, while Bundesministerium für Gesundheit [Federal 2012;380:9846. Health Ministry] Rahmengesundheitsziele we often speak indiscriminately of für Österreich. [Framework health targets 3 “Doctors dismayed as public health committee is intersectoral governance, the evidence for Austria]. Available at: http://www. scrapped”. The Guardian, 8 November 2012. Available gesundheitsziele-oesterreich.at/ideen-sammlung/ and the case studies presented in this issue at: http://www.guardian.co.uk/politics/2012/nov/08/ ergebnisse-der-ideensuche-mai-bis-august-2011 show that each governance structure has doctors-dismay-public-health-committee its own profile in terms of the intersectoral 11 Gauvin FP. Involving the public to facilitate or 4 McQueen D, Wismar M, Lin V, Jones CM, see Table 1 trigger governance actions contributing to HiAP. actions ( ). Therefore, the choice Davies M (Eds). Intersectoral governance for Health In: McQueen D, Wismar M, Lin V, Jones CM, of intersectoral governance structures in All Policies. Structures, actions and experience. Davies M (Eds). Intersectoral governance for Health must follow the desired intersectoral Copenhagen: WHO Regional Office for Europe in All Policies. Structures, actions and experience. on behalf of the European Observatory on Health action. Second, the evidence we have (See Reference 4). collected shows that intersectoral Systems and Policies, 2012. 12 Brand H, Michelsen K. Collaborative governance: governance structures rarely work in 5 Department of Health. Healthy Lives, Healthy the example of health conferences. In: McQueen D, People: Our strategy for public health in England. isolation. There are other intersectoral Wismar M, Lin V, Jones CM, Davies M (Eds). London: The Stationery Office, 2010. governance structures working in parallel. Intersectoral governance for Health in All Policies. Third, there is a need for action at various Structures, actions and experience. (See Reference 4).

New HiT for Cyprus between the public and private sectors. The public system suffers from long waiting lists for many services, while the private sector has an overcapacity of expensive medical By: M Theodorou, C Charalambous, C Petrou and J Cylus technology that is underutilized. To try to address these and Copenhagen: World Health Organization 2012 other inefficiencies, a new national health insurance scheme, (acting as the host organization for, and secretariat of, the funded by taxes and social insurance European Observatory on Health Systems and Policies) contributions, has been designed to Health Systems in Transition Vol. 14 No. 6 2012 offer universal coverage and Number of pages: 128, ISSN 1817-6127 Vol. 14 No. 6 introduce competition between the Available online at: http://www.euro.who.int/__data/assets/ Cyprus public and private sectors through Health system review pdf_file/0017/174041/Health-Systems-in-Transition_Cyprus_ changes in provider payment Health-system-review.pdf methods. However, implementation of the scheme has been repeatedly

Mamas Theodorou Cyprus has a dual health care system, with separate public and Chrystala Charalambous postponed mainly due to cost Christos Petrou private systems of similar size. The public system, which is Jonathan Cylus concerns. Despite the low share of financed by the state budget, is highly centralized and tightly economic resources dedicated to controlled by the Ministry of Health and entitlement to receive health care and access issues for free health services is based on residency and income level. some vulnerable population The private system is almost completely separate from the groups, overall Cypriots enjoy good public system and for the most part is unregulated and largely health comparable to other high-income countries. financed out of pocket. In many ways there is an imbalance

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THE ROLE OF PARLIAMENTARY SCRUTINY IN PROMOTING HiAP

By: Ray Earwicker

Summary: This article explores the contribution of parliaments to an intersectoral governance framework that promotes Health in All Policies (HiAP) by drawing on the system of parliamentary scrutiny in England, using as a case study the House of Commons Health (Select) Committee inquiry into health inequalities in 2009. The Committee’s report contained practical suggestions and recommendations which are now part of the wider discussion about promoting effective governance in HiAP to tackle health inequalities and to reduce the health gap. It also encouraged a more consensual approach between the political parties by drawing on the evidence, helped win wider support for an approach recognising the wider causes of health inequalities, and demonstrated the scope for action across a range of policies needed to address them.

Keywords: Health Inequalities, Health Select Committee, Parliamentary Scrutiny, Health in All Policies, England

Introduction (HSC) inquiry into health inequalities in 2009. It will also look at the links While intersectoral governance usually is between this inquiry and the wider health seen as the realm of government ministers, inequalities perspective provided by the policy-makers and other stakeholders, review published by Sir Michael Marmot including regional and local government, in 2010 (the Marmot Review). 1 and voluntary and private sector agencies, parliaments also have a role to play through agenda setting, promoting a The role of the HSC cross-government approach and wider In the Westminster Parliament, each political ownership, and providing department of state is ‘shadowed’ by an practical suggestions that can improve the all-party parliamentary select committee, quality of policy-making and the focus of with a minimum of eleven members, implementation and action. and whose membership usually reflects the relative strength of each party in This article explores the contribution of parliament. All select committees are parliaments to an intersectoral governance formal parliamentary institutions that framework that promotes Health in Ray Earwicker is Senior Policy can influence and shape policy-making All Policies (HiAP) by drawing on the Manager, Health Inequalities Unit, through reports and recommendations. Department of Health, United system of parliamentary scrutiny in Select committees decide on lines of Kingdom. Email: ray.earwicker@ England, using as a case study the House dh.gsi.gov.uk inquiry and gather written and oral of Commons Health (Select) Committee

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government departments, 2 and the annual Report highlighted the need for effective monitoring of a number of performance coordinated action across government Box 1: Topics included in the HSC targets on the wider determinants of through a HiAP approach as many of enquiry written evidence health through a series of reports and the direct causes of health inequalities other updates. 3 The rising profile of health lay outside the health sector and beyond • Extent to which the National Health inequalities attracted the attention of the health policy. It called for the DH to lead Service (NHS) can contribute to HSC at the end of 2007 and, in particular, action on health inequalities across all reducing health inequalities; whether the health inequalities target sectors and government departments, and • Distribution and quality of general would be met. The HSC was concerned to promote joined-up working. In addition, practitioner services; that the target was unlikely to be met the report noted that the findings of the under the current framework of policies forthcoming Marmot Review on health • Effectiveness of public health and indeed, was worried that the gap was inequalities 1 would provide a unique services; actually widening. opportunity for the government to show • Effectiveness of specific its commitment to introducing rigorous interventions; While the link between policy action and methods for evaluating policy initiatives. its impact was complicated by time lags in • Success of the NHS in coordinating the data, it was clear that effective action The impact of the HSC report its activities; required a balance between the wider • Effectiveness of the DH; social determinants of health, for example In its formal response to the HSC report, housing, child poverty and education, as published in May 2009, 6 the government • Whether the government was likely well as health service and lifestyle factors. emphasised its determination to reduce to meet its health inequalities The Committee began receiving written health inequalities and outlined a series targets. evidence and invited views on a broad of direct actions across government range of related factors (see Box 1). One departments, and at regional and 5 Source: hundred and fifty-four pieces of written local level. The government response evidence were submitted by stakeholders emphasised that it had learned from the during the enquiry, ranging from growing volume of evidence, noting that evidence, including expert witnesses. pharmaceutical and food manufacturers a decade ago there was little evidence All evidence is published and an inquiry to the medical Royal Colleges, academic about what to do and how to do it. The report requires an official response and experts and the DH. The Committee response also focused on the national is followed by a parliamentary debate proceeded to clarify the issues raised in target to identify priorities for action, to which the relevant government the written evidence and other material understand what works, and develop minister responds. by taking a number of expert or interested evidence-based resources for local use. witness statements (oral evidence) in The HSC is the relevant select committee eleven sessions over eighteen months. A more general impact of the Report for the Department of Health (DH) in These witnesses were drawn from a may be seen from its role in keeping England. Its role is to apply effective wide range of interest groups, including health inequalities on the policy and scrutiny of the department’s expenditure, scientific and other experts, groups public agenda. This was evident from administration and policy, and by representing a wide range of health and the parliamentary debate that followed extension that of the government. The related issues, officials and ministers. its publication and through media HSC’s inquiry into health inequalities took coverage. It also helped to shape policy in place from 2007 to 2009 and demonstrates The Committee’s report, published conjunction with other reports that were how this process can enable parliament to on 15 March 2009, found that the causes published either around the same time play a part in tackling health inequalities of health inequalities were complex. These or shortly afterwards, particularly the and promoting a HiAP approach. causes included lifestyle factors, as well Marmot Review. as the wider social determinants of health, The HSC inquiry and report but access to health care seemed to play a It is clear that the HSC report helped to less significant role. 4 While support was set the policy agenda, notably through Tackling health inequalities has been a given to government efforts in tackling its recognition of the high importance of priority area in England since 1997. It now health inequalities nationally, these action on health inequalities, the value has bi-partisan support since its status as positive aspects had to be offset against of a cross-government approach, the use a priority was reaffirmed by the coalition the continued scarcity of good evidence of a target as a catalyst for action and government that took office in May 2010. and lack of proper evaluation of current the underlying need for a scientific and Over the past ten years, there have been a policy that had hindered the design and evaluative approach. Public interest in series of initiatives, including a national introduction of new policies. In particular, the Committee’s work is perhaps best target, a national strategy that promoted apart from calling on the government illustrated by the decision of the BBC to intersectoral collaboration and encouraged to reaffirm the health inequalities devote virtually the whole of its half-hour an HiAP approach across twelve targets for the next ten years, the HSC lunch-time news programme (The World

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at One) to health inequalities to coincide The scrutiny exercise provided by the References

with the opening of the inquiry’s oral HSC report contributed to the wider 1 Marmot M. Fair society, healthy lives (The Marmot evidence sessions on 13 March 2008. debate that informed the Marmot Review Review). London: University College London, 2010. and also directly shaped the Review’s 2 Department of Health. Tackling health inequalities: The systematic debating of select thinking on several key points, including programme for action. London: Department of Health, committee reports in the House of the use of evaluation. Other shared focal 2003. Commons has increased their influence points included concern over the scale and 3 Department of Health. Tackling health inequalities: and their ability to set the wider agenda timing of policies, the need to reconcile status report on the programme for action. London: by engaging government directly and long-term goals with short-term gains, Department of Health, 2005. requiring relevant ministers to respond to and the need to pay better attention to the 4 House of Commons. Health committee: their findings. The HSC inquiry debate planning process as a way of integrating health inequalities – third report of the session on 12 November 2009 was no exception. action on the social determinants of health, 2008–09, volume 1 (HC286-I). London: The The role of the social determinants including through linking planning, Stationery Office, 2009. Available at: http://www. of health and a HiAP approach were transport, housing, environment and publications.parliament.uk/pa/cm200809/cmselect/ a prominent aspect of the debate, health systems. cmhealth/286/286.pdf particularly in light of one of the HSC’s 5 Earwicker R. The role of parliaments: the case of a parliamentary scrutiny. In McQueen DV, Wismar key findings – that lack of access to good Conclusion health services did not appear to be the M, Lin V, Jones CM, Davies M (Eds). Intersectoral governance for Health in All Policies. Structures, major cause of health inequalities. This The impact of the parliamentary scrutiny actions and experience. Copenhagen: WHO Regional highlighted that greater focus on local process on raising the key issues around Office for Europe on behalf of the European programmes and local actions, such as the health inequalities agenda is shown Observatory on Health Systems and Policies, 2012.

Sure Start children’s centres, was required. by the work of the HSC. The Committee’s 6 HM Government. The Government’s response The role of adequate housing, cutting report contained practical suggestions and to the Health Select Committee report on health crime and improving access to jobs, recommendations which are now part of inequalities (Cm 7621). London: The Stationery education, as well as health services, were the wider discussion about what happens Office, 2009. also raised by Members of Parliament. The next in promoting effective governance 7 HM Government. Healthy Lives, Healthy People: complexity of factors that contributed to in HiAP to tackle health inequalities and Our strategy for public health in England. London: health inequalities was emphasised in the to reduce the health gap. The HSC also The Stationery Office, 2010. Available at: http:// public health minister’s reply to the debate. encouraged a more consensual approach www.official-documents.gov.uk/document/ cm79/7985/7985.pdf between the political parties by drawing on the evidence and the data, helped win 8 Department of Health. Health and Social Care wider support for an approach recognising Act explained. London: Department of Health, 2012. Available at: http://www.dh.gov.uk/health/2012/06/ the the wider causes of health inequalities, and act-explained demonstrated the scope for action across a HSC report range of policies needed to address them.

helped to set the The HSC report’s findings also remain relevant in the context of the new coalition policy agenda government’s explicit commitment to fairness and social justice, mirrored by At a broader level, the appointment of the establishment of new social justice the independent Marmot Review on and public health cabinet committees. In health inequalities in November 2008 conjunction with the Marmot Review’s and the publication of its influential findings and recommendations, the HSC’s report in 2010, 1 gave new impetus to the work has helped health inequalities remain debate and offered‘‘ a way of embedding a priority. This was reflected, among other health inequalities in mainstream policy things, in the government’s decision to and political agendas, including the create a new duty on the Secretary of State government’s white paper on public for health and the NHS to have regard for health. 7 Health inequalities were the need to reduce health inequalities in increasingly recognised as a major their decisions from 1 April 2013. 8 concern and addressing them was part of the way that business was done in the NHS and other public services, including through planning, delivery and performance processes, and in fostering better governance and the promotion of a HiAP approach.

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INTERSECTORAL PROBLEM SOLVING BY INTERDEPARTMENTAL UNITS AND COMMITTEES

By: Scott Greer and Anna Maresso

Summary: Interdepartmental committees and units can expect to have different degrees of success in providing potential solutions to coordinating government policies and operating intersectorally. There is variable scope for them to contribute to a range of governance outcomes, including evidence, coordination, advocacy, monitoring, guidance development and implementation. The appeal of interdepartmental committees and units is that they work within the government bureaucracy, do not require significant costs or reorganisation, can work with departments over time, and can apply sustained pressure. They can work in multiple situations but are less useful in resolving political conflict.

Keywords: Interdepartmental Committees, Interdepartmental Units, Intersectoral Governance, Health in All Policies

Introduction (or possibly political appointee) level of departments. They might shadow a Both interdepartmental committees and ministerial committee or be serviced by an interdepartmental units are intersectoral interdepartmental unit. Such committees governance structures that try to reorient appear throughout the history of modern existing government ministries around public health. Today, there are many a shared, intersectoral priority. Both examples of interdepartmental committees of these mechanisms operate within within European administrations, such as the bureaucracy and their fundamental the Public Health National Committee in justification is that they can move France (designed to improve coordination the bureaucracy to engage in such and information among the main intersectoral priorities. Their vigour, ministries whose policies may have a though, depends on their ability to health impact, particularly prevention persuade other bureaucrats to engage with Scott Greer is Associate Professor, and health security); the Traffic Safety them, which is much more likely if they School of Public Health, University Committee in Slovakia (whose narrower of Michigan, Ann Arbor, USA. have strong political backing. Anna Maresso is Research Officer, remit and detailed tools have contributed European Observatory on Health to a dramatic decrease in road fatalities); Systems and Policies and LSE The role of interdepartmental the Interdepartmental Public Health Health, the London School of Economics and Political Science, committees and units Committee in Hungary (which assisted the implementation of the National Public London, UK. Interdepartmental committees are made Email: [email protected] Health Programme) and several permanent up of representatives from the civil service

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Table 1: Conflict, salience and coordination challenges can continue to carry out the political mission of intersectoral governance when High Political Importance Low Political Importance the politicians have been called away High conflict Situation 1. Interdepartmental Situation 2. An interdepartmental to other tasks, acting as a delegate for a committees and units might clarify committee or unit with strong minister who can be distracted by politics issues but resolution depends on political support could impose a or sucked into administration. political will. solution. Risk of departmental sabotage. The potential weakness of Low conflict Situation 4. Optimal for Situation 3. Interdepartmental interdepartmental units is that they may interdepartmental committees and committees and units very useful be side-lined as being too intellectual, units – strong political backing and – committees can clarify problems few political conflicts. and solutions while units can add too impractical or too distant from the missing energy to the issue. preoccupations of the bureaucracy. Three broad kinds of responses can meet this challenge. One is that political will Source: 5 . Note: A high conflict situation is one in which there is little or no basic agreement. Political importance is the extent ultimately does matter and that a unit has a to which an issue matters to the government, especially its senior politicians. chance of being effective if it is known that it ‘belongs’ to a senior minister who will inter-ministerial committees coordinated Interdepartmental units are groups of advocate and defend it if necessary. The by the Finnish Ministry of Social Affairs civil servants, deployed and organised second is that personnel matters, making and Health that focus on aspects of health specifically to pursue a particular policy it imperative that the unit be staffed to promotion such as occupational health, issue or agenda. They are typically combine technical competence, energy rehabilitation, gender equality and child delegates of somebody (ministerial and a sense of the relevant bureaucratic and adolescent health. 1 Moreover, nearly committee or a central government and political issues. The third is strategy, every European Union (EU) Member State minister) and they differ from agencies in whereby the unit makes itself a credible has some kind of committee structure that they are not responsible for delivering ally for at least some of the interests within responsible for coordinating EU policy. any services. Rather, they are creatures of affected sectors, rather than being solely the need to coordinate policy rather than an in-house critic alienating departments The virtue of interdepartmental autonomously deliver a service as agencies and their ministers. committees is that representatives are generally created to do. 2 Such units of the different relevant units use also often attract scholars, consultants and them as a forum for problem solving. policy entrepreneurs as outsiders who can Committees lower the costs of a decision provide new ways of thinking. a forum by maximising the relevant information made available, and lower the costs of In the UK, most attention recently has for problem implementation by involving the affected gone to units such as the Prime Minister’s interests (departments) in the decision. Delivery Unit (charged with monitoring solving Regular committee meeting schedules can delivery on a broad range of key goals such 3 also be a stimulus to action: they allow as shorter elective surgery waiting times) Problem solving participants to review new information, and the Performance and Innovation actions and progress, which thereby Unit (responsible for identifying ways Intersectoral governance often must face creates deadlines capable of forcing in which the government could organise coordination problems that have a political some information provision, action, itself to deliver better services. 4 Another rather than simply a bureaucratic source; and progress. experiment was a unit to deal with the that is, the government does not agree homeless living on the streets that focused within itself. There are four quite common The weakness of interdepartmental on the joining up of relevant aspects of situations‘‘ which highlight the nature and committees is that they may fall prey local government, housing, social work extent of this problem, both in terms of the to a number of pitfalls. One is depleted and health services, 5 as well as drug harm level of conflict between ministries and energy: the committee ceases to meet or reduction programmes. the political importance of the issue that high-ranking members send low-ranking needs coordinated action. Consequently, deputies and thus its mission is forgotten. The virtue of interdepartmental units, interdepartmental committees and units A second is irrelevance: departments above all else, is that they have staff which can expect to have different degrees might send representatives but do not can dedicate their time and energies to of success as the potential solution to actually feel committed to the agenda or intersectoral work, a task that often takes the coordination problem. The four its implementation. A third is sabotage: place outside the rhythms of established situations are: departments may use the committee solely bureaucracies and the frenzies of daily as a way to spy on people who might ask politics, which can redirect government them to do things that they dislike. activity and the focus of ministers. A unit

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1. Two ministries refuse to agree because interdepartmental committees and units functioning committee could co-opt their ministers refuse to agree. A to contribute to a variety of governance member departments’ resources. The common example would be conflict outcomes: UK Prime Minister’s Delivery Unit between the ministries of health and was a success in this regard because finance over tobacco control. Evidence: An interdepartmental monitoring requires energy and it was able committee is a forum for aggregating to deal with the conflict that monitoring 2. Two ministries refuse to agree about information; this could include engenders. It is more likely to work in some minor problem and no senior information from around government but low-conflict situations but can work in official or minister thinks the issue is as a structure for this purpose, it might high-conflict ones. a priority. An example here would be be inefficient. A unit is more commonly disputes over the role and cost of health found in this role, with tasks ranging Guidance development: Done by a care in schools or prisons. from collecting existing information to committee it can be reduce conflict 3. Two ministries do not have particular commissioning or performing research, but paradoxically this is more likely in disagreements but need to iron out engaging in public debates or simply situations where there are already low the details and do not necessarily get informing ministers. In principle, levels of conflict. Done by a unit, guidance around to fixing the problem. An evidence is a function that a unit or development can reduce transaction costs example here might be implementing a committee could fulfil in any of the four in formulation but requires diplomacy and policy that allows home care visitors to situations, although higher conflict makes political support to be implemented. This older people to carry out multiple tasks information harder to gather and creates means that it works best in situations 3 such as health visiting, checking smoke more risk that evidence will be ignored and 4 where the problem is technical rather detectors, and helping with official or incur retribution. than political. paperwork, which in practice is difficult to coordinate. Coordination: This administrative Implementation and management: While ‘holy grail’ means having the processes departments and agencies implement 4. Two ministries basically agree on necessary to promote intersectoral policies, the monitoring and evidence the need to cooperate because it is working, including allocating activities of interdepartmental committees an important government agenda responsibilities and making sure that and units may feed into implementation. item, they do not disagree much, and bureaucracies carry out their tasks. Also, senior ministers want cooperation. coordination can resolve differences and While interdepartmental committees For example, this was the case with even build trust, and ideally should be and units can achieve these goals, they the English task force on helping carried out by experts in bureaucracy. should not distract from the fact that the homeless sleeping on the streets, Therefore, a committee is the logical existing units and committees frequently mentioned above. choice and it can carry out the task in low- are low-cost established mechanisms as conflict situations. An interdepartmental well. Interdepartmental committees, in Based on a framework by Page, 5 committee is only likely to coordinate particular, do not capture all bureaucratic Table 1 presents these four situations in in high-conflict situations, for example, interdepartmental coordination within a grid, along with the potential role of if there is a very clear political demand government; nor should we think that only interdepartmental committees and units. to resolve the issue or if it is backing a those committees and units led by health In general, the worst situation for a unit ministerial committee or other political specialists are of special interest to health or committee is Situation 1 when they process designed to resolve the issue. policy. Service on committees and units are as likely to be damaged in a conflict led by other departments, and participation between top politicians as to be effective Advocacy: The virtue of a unit is that in their consultation mechanism, is in mediating high-level political conflicts. it can add energy. Advocacy requires ubiquitous and, if used well, a vital This was basically the situation of the New energy and a unit should be well suited to technique for intersectoral governance. Zealand Public Health Commission, which this role as long as it is either working on managed to offend so many high-level relatively non-contentious issues or has politicians and affected interests that it Conclusion strong political support (or both). A unit in was abolished only three years after it was a high-conflict, politically salient situation The appeal of interdepartmental created. Situation 4 is the best scenario for probably needs the backing of the most committees and units is that they work units and committees as they can bring senior politicians to survive, let alone win. within the government bureaucracy, do not their respective advantages to bear on an A unit in low-salience situations can be require significant costs or reorganisation, intersectoral task that the government particularly useful, particularly if energy can work with departments over time, and supports and that does not involve too is lacking from other quarters. Finally, can apply sustained pressure. They can many interdepartmental conflicts. a unit in a high-salience, low-conflict work in multiple situations but are less situation is likely to be very successful. useful in resolving political conflict. There Governance outcomes are two summary lessons. First, political Monitoring: Monitoring is best done support is helpful for committees and Using the map of situations outlined by a unit, though in theory, a high- units to work best. Second, a combination in Table 1 one can see the scope for

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is a good idea – a unit to provide energy CAN JOINT and a committee to resolve technical issues, as well as political leadership such as a ministerial committee to BUDGETING FACILITATE channel and contain political disputes. Such a combination should be powerful and effective. INTERSECTORAL References ACTION? 1 Greer S. Interdepartmental units and committees. In McQueen DV, Wismar M, Lin V, Jones CM, Davies M (Eds) Intersectoral governance for Health in All Policies. Structures, actions and experience. Copenhagen: WHO Regional Office for Europe on behalf of the European Observatory on Health By: David McDaid Systems and Policies, 2012.

2 Talbot C. The agency idea: sometimes old, sometimes new, sometimes borrowed, sometimes untrue. In Pollitt C, Talbot C (Eds) Unbundled government: a critical analysis of the global trend to Summary: The importance of looking beyond the health sector when agencies, quangos and contractualisation. Abingdon: Routledge, 2004. promoting health is a core mantra of public health, but too often there 3 Barber M. Instruction to deliver: Tony Blair, are organisational and financial factors which hamper the achievement the public services, and the challenge of delivery. London: Politico’s, 2007. of this goal. Potentially the use of some form of joint budgeting 4 Performance and Innovation Unit. Wiring it up: mechanism may help overcome some of these barriers and promote Whitehall’s management of cross-cutting policies and services. London: Cabinet Office, 2000. collaboration on health-related actions within and across the work of 5 Page EC. Joined-up government and the civil different sectors and agencies. This article provides an overview of service. In Bogdanor V (Ed) Joined-up government. Oxford: Oxford University Press /Cabinet Office, different approaches to joint budgeting and experience to date. Factors 2005. that have influenced the success or failure of schemes are highlighted, including the crucial need to identify non-health benefits arising from health promotion interventions implemented and/or funded outside the health care sector.

Keywords: Joint Budgeting, Intersectoral Action, Public Health, Health Promotion, Health In All Policies

Introduction holders. 1 Thus, opportunities to realise substantial health, non-health and other Good horizontal relationships between economic benefits may be missed. 2 health and other sectors are critical to the implementation of actions for better In practice, mechanisms by which Health in All Policies (HiAP). While this services are funded act as catalysts or is by no means a new idea, nonetheless it barriers to action. The long-term nature is an issue that often is either neglected of many health promotion and public or has been challenging to implement, health initiatives, requiring actions with a focus therefore on actions that and funding across different sectors, take place within different departmental has long been vulnerable to resource David McDaid is Senior Research fiefdoms and budgetary silos. Moreover, constraints and uncertainties. Multiple Fellow at LSE Health and Social Care health promotion is unlikely to feature and at the European Observatory short-term funding streams, often with prominently as a key goal for most on Health Systems and Policies, tight restrictions on how funding can be London School of Economics and departments and non-health sector budget Political Science, United Kingdom. used and subject to different financial Email: [email protected] incentives and cost containment concerns,

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can act as major impediments to the efficient use of resources for Health in Box 1: Different approaches to joint budgeting All Policies (HiAP). For example, despite a growing evidence base supporting the effectiveness of interventions in the first Budget alignment: Budgets may be aligned rather than actually joined together. For years of school to tackle bullying and instance, a commissioner of health services can manage both a health budget and a conduct problems, the education sector separate local government budget to meet an agreed set of aims. may be reluctant to invest its limited Dedicated joint funds: Departments may contribute a set level of resources to a single resources in school-based mental health joint fund to be spent on agreed projects or delivery of specific services. This may often promotion programmes rather than on be a time-limited activity. There is usually some flexibility in how funds can be spent. core education-related activities. However, changing funding arrangements could Joint-post funding: There may be agreement to jointly fund a post where an individual actually help to overcome some of is responsible for services and/or attaining objectives relevant to both departments. these narrow sector-specific interests. Theoretically, this can help to ensure cooperation and avoid duplication of effort. Cross-sectoral collaboration could be Fully integrated budgets: Budgets across sectors might become fully integrated, with fostered through establishing one single resources and the workforce fully coming together. One partner typically acts as the budget for the provision of school-based ‘host’ to undertake the other’s functions and to manage all staff. To date, this largely has health promotion. been restricted to partnerships between health and social care organisations or for the provision of services for people with mental health needs. Creating a dedicated budget for a non- health sector health-promoting activity, Policy-orientated funding: Central or local government may set objectives that cut across bringing together resources from the ministerial and budget boundaries and the budget system. Money may be allocated to health sector and beyond, provides health specific policy areas, rather than to specific departments, as has been seen in Sweden policy-makers with a direct means of and England. influencing policy in other sectors. For Source: 5 instance, the approach might be used to ensure that adequate funding and priority is given to road safety measures by ministries of transport, or to address from fully integrated budgets for the Experience in joint budgeting health concerns in new urban housing provision of a service or policy objective Examples of joint budgeting and developments. It has also been argued to loose agreements between sectors to discussion in policy documents in the that funding across sectors could help align resources for common goals while health sphere can be identified in a to eliminate unnecessary gaps and maintaining separate accountability for number of countries, including Australia, duplications in services. 3 Pooling funds the use of funds (see Box 1). Agreements Canada, England, Italy, the Netherlands may help to reduce administrative and on joint budgeting can be mandatory or and Sweden. 6 A feature of many of these transaction costs, generating economies of voluntary and may operate at a national, initiatives is that they focus on easily scale through sharing of staff, resources regional and/or local level. This may be identifiable population groups that have and purchasing power, while also accompanied by legislation and regulatory a clear need not only for health care facilitating rapid decision-making. 4 instruments. There may be very detailed services but also support from services agreements between sectors on how such as social care, education, housing budgeting mechanisms will work; for and employment. Continuity of care instance, they may include identification and support for these population groups of any host partner, clarity on functions, joint requires a coordinated approach across agreed aims and outcomes and the levels sectors and schemes. Initiatives often of contributions, as well as the relevant budgeting have been set up with the explicit aim of accountability issues. Such agreements overcoming the fragmentation of funding may also deal with the ownership of covers different and service provision that has hindered the common premises and equipment, as well development of seamless care pathways. mechanisms as how any surpluses or liabilities are dealt with. The temporal nature of joint The four countries that make up the United budgeting arrangements also varies – they Implementing joint budgeting Kingdom, as well as Sweden, have been can be time-limited, short-term initiatives, particularly prominent in the joint funding The term ‘joint budgeting’ can itself particularly when receiving grant funding of services and programmes to support cover a number of quite different from central government, or envisaged older people who may be frail, as well mechanisms, involving two or more as a longer-term, more permanent as those who have physical disabilities government departments and /or tiers of organisational change. ‘‘ or chronic health problems, including government, in order to help achieve one mental health needs. 4 Pooled budgets or more shared goals. They can range also have been used to help develop joint

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Effectiveness of joint budgeting Conclusions

Box 2: Factors that can aid The evidence on the effectiveness of Experience from several high income implementation of joint budgets joint budgeting arrangements is limited countries of intersectoral work with and at times rather equivocal. Despite some form of shared or aligned budgets • Identify rationale, potential health the formal advantages of overcoming indicates that when it comes to joint and non-health benefits and added narrow sectoral interests and promoting budgeting arrangements, no one approach value to sectors pooling resources flexible funding, as yet there is no strong is ideal in all circumstances. While the evidence that joint budgets have made legal frameworks under which joint • Establish clear outcomes to be a difference to final outcomes and little budgeting operates may be established achieved is known about their cost-effectiveness at national level, there appears to be a • Speak the languages of all sectors, compared to previous arrangements. 10 greater likelihood that schemes will be not just that of the health sector Exceptions can be noted, as with some more successfully implemented at a very experiences in transport safety in the local level. The implication is that the need • Determine how current funding and United Kingdom where the impact of to tailor joint budgeting arrangements to legislative frameworks are operating jointly funded actions on casualty rates meet different contexts and institutional across sectors can be identified as a key indicator of arrangements may mean that above a • Move towards flexibility in legislative success. 11 In Sweden, cross-sectoral certain geographical or budgetary size, and regulatory frameworks initiatives have been the subject of much schemes become too difficult to manage. governing joint budgeting evaluation. One example is the SOCSAM scheme which allowed social insurance Careful consideration must also be given • Engage in sustained efforts to build and social services to voluntarily move to the design of any joint budgeting cross-sectoral trust, and training in up to 5% of their budgets, along with a initiative, taking account of context common skills and competencies matched contribution from health services, and resource, and whether schemes are • Consider use of performance-related to a pooled budget to jointly manage mandatory or voluntary. In the short-term, incentives rehabilitation services to help individuals the mandatory pooling of budgets and on long-term sick leave to return to work. de facto requirements that different sectors • Identify economic costs and It was evaluated in eight localities and collaborate may help to facilitate HiAP benefits of joint budgets compared with experiences elsewhere and will provide opportunities for mutual • Consider using financial instruments in the country where schemes were not learning across sectors. However, the to ensure that where budgets introduced. The evaluation found that imposition of these schemes from above are aligned rather than shared all interdisciplinary collaboration between may mean that there is resistance from sectors can benefit equally from any health and social care professionals different sectors, which may not augur efficiency gains made. improved compared to control areas. 12 This well for their long-term sustainability. Swedish experience also suggests that joint On the other hand, approaches that are Source: 5 funding arrangements and collaboration at voluntary will take more time to establish. local or regional level, where institutional They rely more heavily on securing structures are closer to stakeholders the buy-in of different stakeholders by and have a better understanding of local demonstrating the potential added value of approaches to rehabilitation and return problems, can be effective. collaboration, both in terms of health and to work for individuals with chronic objectives of importance to other sectors. health problems, as is the case for those A number of factors that can aid the with musculoskeletal health problems in implementation and effectiveness of joint Where they are well implemented, Sweden, where the health, social insurance budgets have been identified (see Box 2), measures to bring budgets together can and social work sectors have worked a fuller discussion of which may be found help embed health impacts in all policies. together to address this issue. 7 In England, in the chapter on joint budgeting in the In the longer-term, if such initiatives Scotland and Wales, road safety initiatives recently published book on intersectoral and partnerships are sustained, then also have brought together partners from governance. 5 It is clear that the process a common working culture can be the health, transport, child and safety must begin by carefully defining health established, reducing potential distrust sectors. 2 In the Netherlands, joint budgets and other policy issues that may benefit and misunderstanding between partners. have been used for research and policy from joint budgeting, considering what It should be stressed though, that joint activities in connection with the national actors and stakeholders need to be budgeting arrangements are more likely action programme on environment involved and understanding their priorities to be successful when complemented by and health, funded by the ministries of and goals. Crucially, partners need to other actions to facilitate intersectoral environment and health, 8 while in New perceive any pooling of resources and actions and improved partnership working. Zealand, ‘clustering projects’ bring structures as being in their own interests, together relevant government agencies to adding value to what they can achieve pool budgets and resources. 9 in isolation.

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References ENGAGING INDUSTRY 1 Timpka T, Nordqvist C, Lindqvist K. Infrastructural requirements for local implementation of safety policies: the discordance between top-down and IN INTERSECTORAL bottom-up systems of action. BMC Health Services Research 2009;9:45. 2 Audit Commission. Changing lanes. Evolving roles STRUCTURES in road safety. London: Audit Commission, 2007.

3 Audit Commission. Clarifying joint financing arrangements. A briefing paper for health bodies and local authorities. London: Audit Commission, 2008.

4 Weatherly H, Mason A, Goddard M. Financial By: Monika Kosińska and Leonardo Palumbo integration across health and social care: evidence review. Edinburgh: Scottish Government, 2010.

5 McDaid D. Joint budgeting: can it facilitate intersectoral action? In: McQueen D, Wismar M, Lin V, Jones CM, Davies M (Eds). Intersectoral Summary: The EU Platform for Action on Diet, Physical Activity governance for Health in All Policies. Structures, actions and experience. Copenhagen: WHO Regional and Nutrition is an intersectoral structure that aims to reach out to Office for Europe on behalf of the European Observatory on Health Systems and Policies, 2012. industry as well as other non-governmental stakeholders to achieve

6 McDaid D, Oliveira M, Jurczak K, Knapp M, common actions on obesity. Members of the Platform are required MHEEN Group. Moving beyond the mental health care system: an exploration of the interfaces between to submit ‘commitments’ to the European Commission which are health and non-health sectors. Journal of Mental monitored through the submission of annual reports. Overall, since Health 2007;16(2):181–94.

7 Hultberg E, Allebeck P, Lönnroth K. Effects of 2005, about 300 commitments have been submitted, with 56% in a co-financed interdisciplinary collaboration model the traditional ‘health promotion’ area, tackling lifestyle modifications in primary health care on service utilisation among patients with musculoskeletal disorders. Work and educational activities and the remainder focussing on marketing 2007;28(3):239–47. or advertising, reformulation and labelling. The increase in formal 8 Stead D. Institutional aspects of integrating transport, environment and health policies. relationships between industry and the public sector in health Transport Policy 2008;15:139–48. promotion clearly raises challenges for health governance, requiring 9 Public Health Advisory Committee. The health of people and communities. A way forward: public policy that such partnerships be well managed, with clearly defined roles, and the economic determinants of health. Wellington: Ministry of Health, 2004. responsibilities and expectations. 10 Audit Commission. Means to an end. Joint financing across health and social care. London: Audit Commission, 2009. Keywords: Industry Engagement, Private-Public Partnerships, Public Health, EU Platform for Action on Diet, Physical Activity and Nutrition 11 Department for Transport. Review of the road safety partnership grant scheme. London: Department for Transport, 2009. Introduction as has the impact of PPPs on our 12 Hultberg E, Lönnroth K, Allebeck P. Co-financing understanding and framing of traditional as a means to improve collaboration between primary The EU Platform for Action on Diet, public health questions. Despite this, the health care, social insurance and social service Physical Activity and Nutrition is a relatively recent nature of joint ventures in Sweden. A qualitative study of collaboration flagship example of a private-public experiences among rehabilitation partners. Health by public and private actors in health partnership (PPP) aimed at tackling Policy 2003; 64(2):143–52. means that their impact, relationships and rising rates of obesity. As such, it is an governance questions are still new, and to intersectoral structure that aims to reach some extent uncertain. Furthermore, some out to industry as well as other non- PPPs in health have been received with governmental stakeholders to establish controversy and high expectations, as well and achieve common actions on a complex as scepticism. and important public health issue. With Monika Kosi´nska is Secretary General and Leonardo Palumbo is governments and public sector actors Policy Coordinator for EU Affairs, looking for innovative ways to face Role and aims European Public Health Alliance, modern challenges, the involvement of Brussels, Belgium. The Platform was established in 2005 industry, through the development of Email: [email protected] and gathers together food and health PPPs, has become increasingly common,

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stakeholders from across Europe. Its Pros and cons for stakeholders of the commitments, on either their creation was spearheaded by concern appropriateness or effectiveness according For economic actors (i.e., industry), their over one of the biggest modern public to public health evidence. However, the participation in what is in effect a self- health challenges – the obesity epidemic. Platform could be considered successful regulatory process provides two ‘wins’: The Platform is not a traditional PPP in terms of its engagement of economic firstly, in the continued absence of direct because there is involvement from non- actors, both in terms of attribution of regulation in this area; and secondly governmental organisations (NGOs), responsibility as contributors to the obesity as their actions can be used to promote there is no direct partnership with the crisis, as well as driving responsibility and their image via public relations activities food industry, and it is a forum to discuss action in tackling obesity. or branded as examples of corporate practices and commitments to activities social responsibility. The benefit for the on healthy nutrition, physical activity and Commission can also be seen as twofold: tackling obesity. 1 achieving action, arguably quicker than through direct regulation, in an area with The Platform became an implementation little political will within Member States; tool for the European Commission’s and enabling a setting where the issues The Platform Strategy for Europe on Nutrition, and arguments can be debated directly Overweight and Obesity-related Health between economic actors and public health has facilitated a Issues, launched in 2007, and remains a NGOs; whereas previously, this had taken high-profile element of the Commission’s place bilaterally between the stakeholders structured public stable of policies targeting overweight and and the Commission, with antagonistic obesity. There is no formal leadership or behaviour between the two sets of discourse management mechanism, and membership stakeholders. The benefit for participating is voluntary. The initiatives are set by the Participation in the Platform also raises a NGOs is less immediately obvious as public sector and currently five formal number of wider governance issues, not the process is time-consuming, resource fields of action have been identified: only in terms of what are considered as intensive and some have argued, also consumer information (including food the ‘proper’ responsibilities of the state distracting from other political discussions ‘‘ labelling); education (including lifestyle or the public sector in health protection or advocacy activities. However, some modification); physical activity promotion; and public health promotion, but also in have remarked that it does benefit their marketing and advertising; composition terms of ensuring ‘well-governed’ PPPs work by maintaining political attention on of foods (reformulation), availability of and their legitimacy, representativeness, the issue of obesity, which is complex from health food options and portion sizes. accountability, transparency and a policy perspective, particularly during An additional area of advocacy and efficiency. These are discussed in periods of low levels of political will. 2 3 information exchange is also included. greater detail in our chapter in the recently published book on intersectoral The distribution of resources within the The Platform was a unique concept as it governance. 4 However, here we briefly work of the Platform has been a topic facilitated a structured public discourse mention two key issues – reputational risk of debate amongst participants and bringing together the public sector, and conflict of interest – and how they highlights the difference in resources industry and NGOs. The theory behind potentially impact on participants of the and abilities of the actors. While both its creation is that it allows for action Platform. NGOs and economic actors are obliged to to be taken within the private sector / provide commitments on action to tackle industry voluntarily and faster than Particularly for NGOs, there are obesity, and to participate in meetings and through legislation. If the results are not reputational issues that need to be discussions, the resource burden on NGOs satisfactory there is still the alternative managed carefully. For many participating is much heavier given the difference in of regulation. Members of the Platform NGOs there are strict guidelines on resourcing between the two. Many feel are required to submit ‘commitments’ the nature of partnerships that can be that industry is better able to commission to the Commission which are monitored undertaken with economic actors. Even expertise in legal, academic, scientific and through the submission of annual so, for NGOs working on population public relations fields whereas non-profit reports. Examples of commitments health, simply participating in a process making organisations depend mainly on include McDonald’s providing nutritional that can be construed as delaying action the goodwill and volunteering of experts. information on packaging throughout to tackle obesity, acting as a distraction Europe and the Union of European Soft from regulatory approaches or ‘approving’ Lastly, the Platform has also been Drinks Association’s pledging not to commitments that may be seen as criticised because commitments and market directly to children under twelve marketing exercises masked as corporate actions of the industry tend to favour across the EU. action to tackle obesity, can be damaging investing in information and education in other contexts, especially where their rather than making healthier food choices primary role as ‘watchdogs’ are central to available or regulating advertising, their constituency and, at times, financial labelling and health claims. In this supporters. In terms of conflict of interest, regard, there is no ‘quality monitoring’

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Figure 1: Number of Platform commitments by geographical coverage and type spirit of the Platform’s objectives. In of action, 2011 addition to this, the economic actors may not be the most competent of actors to put forward evidence-based health Education/lifestyle modification 24 3 15 promotion activities. Finally, there may be conflicts of interest when the producers, Information exchange/advocacy 4 1 17 manufacturers or retailers of products that are high in fat, salt or sugar (HFSS) are Marketing and advertising 1 2 13 also involved in providing educational campaigns on healthy eating.

Physical activity 7 1 7 Regarding marketing and advertising to children, there is already a regulatory Reformulation 6 9 framework with the EU Audiovisual Media Services Directive 9 which provides Consumer information/labelling 5 8 guidance on the protection of minors.

0 10 20 30 40 50 However, the economic actors largely attribute the Platform in their adoption ■ National ■ Regional ■ European of commitments for self-regulatory approaches in this area. Although it is Source: 6 . Note: N=123. difficult to prove or disprove to what extent the extension or continuation of at times commercial actors could use involved are themselves the producers of existing activities have been strengthened their PPP interaction to gain political products leading to poor health outcomes. due to their participation in the Platform, and market intelligence in an attempt to However, this presumes a willingness the evaluation of the Platform found that gain political influence or a competitive of industry to take responsibility for in the context of these commitments, edge over companies who are not seen the outcomes of the consumption of its the exposure of children to marketing of as government partners. 5 Moreover, as products and that it does not use PPP HFSS foods has decreased. However, due relatively new entities, little is known in involvement for cynical purposes – for to factors such as the limited number of the literature on how PPPs operate and example, using it merely as a delaying products chosen for the commitment and what they achieve. 7 This potential conflict tactic to prevent robust regulation. the definition and threshold age of the of interest is raised frequently during the target audience, this decrease was over- Platform, particularly in discussions on Overall, since 2005, about 300 reported by economic actors. 8 the role of economic actors in providing commitments have been submitted under promotional or educational campaigns the Platform, with 56% in the traditional In contrast, reformulation does not have on healthy living. Thus, the balance ‘health promotion’ area, tackling lifestyle any corresponding ‘hard’ EU regulatory between corporate support for public modifications and educational activities framework. Reformulation makes up health messages and the need for robust, and the remainder of the commitments about one quarter of the total Platform evidence-based public health promotion focussing on marketing or advertising, commitments and can be considered to be strategies is a fine one that needs to be reformulation and labelling, the latter largely successful. These commitments navigated carefully in practice. being what NGOs would consider the were taken up by multinationals on a ‘real’ action to tackle obesity. 8 In 2011 wide range of products, or a significant PPPs as a lever for health change? there were 123 commitments whose share of HFSS products, affecting both application according to geographical area existing new products and affecting a The traditional model of public sector and topic was quite varied. The majority significant number of products in general, responsibility for the health and wellbeing of actions promised in 2011 are education with 25–50% (but up to 80%) reduction in of populations could be considered to and lifestyle modification commitments, fat, salt or sugar. 8 have led to a fragmented approach to followed by initiatives in information tackling health issues; that is, activities are exchange and advocacy, and those tackling The multi-stakeholder model has also health sector-led in isolation from other marketing and advertising (see Figure 1). been exported to national levels, forming sectors and organisations. In this sense, part of initiatives in a number of countries the increased engagement of the private In particular, NGOs have been concerned including Germany (to combat obesity), sector in health promotion can be seen about the large number of health Poland (to promote good diet and physical as an extension of the realisation of the promotion actions that are put forward by activity), Portugal (salt reduction and Health in all Policies (HiAP) approach, the economic actors on the basis that many school fruit programme), and Hungary in using the drivers and resources outside of the commitments target the employees (educational programmes on salt). the health sector. It could also be seen as of the economic actors themselves and risk-sharing, where the industry actors thus are not sufficiently within the

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Conclusion importance or the potential for public 4 Kosi´nska M, Palumbo L. Industry engagement. controversy surrounding a topic can affect In: McQueen DV, Wismar M, Lin V, Jones CM, Given the complexity of the political the drive for, and implementation of, a PPP Davies M. Intersectoral governance for Health in context and regulatory framework, as well All Policies. Structures, actions and experience. on an issue. as the multiplicity of challenges raised Copenhagen: WHO Regional Office for Europe by the prevalence of obesity in Europe, on behalf of the European Observatory on Health However, despite the questions that remain Systems and Policies, 2012. it is hard to draw a simple conclusion on and the clear need for more research, it is 5 the Platform’s success overall. Certainly, Richter J. Public-private partnerships for important not to lose sight of the fact that it has acted as an innovative process to health: a trend with no alternatives? Development often PPPs, such as the Platform, are put 47(2);2004:43–48. bring together actors with very different forward where regulation, the traditional 6 interests. Dialogue within the Platform Vladu C, Christensen R, Pan˘a A. Monitoring the government tool, is not achievable for has become more constructive and less European Platform for action on Diet, Physical Activity political or financial reasons. In addition, and Health activities. Annual Report 2012. Brussels: confrontational over the years, although throughout its existence as a discipline, European Commission, 2012. Available at: http:// it still retains a clear divide between the public health has always trod the line ec.europa.eu/health/nutrition_physical_activity/ economic and non-economic participants. docs/eu_platform_2012frep_en.pdf of trade-off and working across sectors Moreover, joint actions between the two 7 and groups. Goel NK, Galhotra A, Swami HM. Public private sets of actors are rare. partnerships in the health sector. The Internet Journal of Health 2007;6(2).

The increase in formal relationships References 8 The Evaluation Partnership. Evaluation of the between industry and the public sector in 1 Hawkes C. Working Paper on public-private European Platform for action on diet, physical activity health promotion clearly raises challenges partnerships for health. Brussels: European and health. Brussels: European Commission DG for health governance, requiring that Commission, 2008. Available at: http://ec.europa. Health and Consumers, 2010. Available at: http:// such partnerships are well managed, with eu/health/ph_determinants/life_style/nutrition/ ec.europa.eu/health/nutrition_physical_activity/ docs/frep_en.pdf clearly defined roles and responsibilities documents/ev20081028_wp_en.pdf 9 as well as expectations, something that 2 Alemanno A, Carreño I. ‘Fat taxes’ in Europe: Directive 2010/13/EU of the European Parliament is, by and large, achieved successfully in A Legal and Policy Analysis under EU and WTO Law. and of the Council of 10 March 2010 on the coordination of certain provisions laid down by the context of the Platform. It is clear that HEC Policy Paper, September 2012. Available at: http://www.gastronomiaycia.com/wp-content/ law, regulation or administrative action in Member more research is needed on the use of PPPs uploads/2012/09/Impuesto_Grasa_Europa.pdf States concerning the provision of audiovisual media to increase the accountability of industry services. Available at: http://eur-lex.europa.eu/ 3 for poor health outcomes. Currently, the WHO European Region Ministerial Conference. LexUriServ/LexUriServ.do?uri=OJ:L:2010:095:0001 European Charter on Counteracting Obesity. :0024:EN:PDF literature does not reflect on whether Copenhagen: WHO Regional Office for Europe, PPPs are more or less effective in different 2006. Available at: http://www.euro.who.int/__data/ industries – pharmaceuticals over food, assets/pdf_file/0009/87462/E89567.pdf for example – nor on how the political

New HiT for Republic of Moldova system with excessive infrastructure, but there is still room for efficiency gains, particularly through the consolidation of specialist services in the capital city. By: G Turcanu, S Domente, M Buga and E Richardson The rationalisation of duplicated specialised services, therefore, Copenhagen: World Health Organization 2012 remains a key challenge facing the Moldovan health system. (acting as the host organization for, and secretariat of, the Other challenges include health workforce shortages European Observatory on Health Systems and Policies) (particularly in rural areas) and improving equity in financing Number of pages: 151 pages, ISSN 1817-6127, Vol. 14 No. 7 and access to care by reducing out-of-pocket (OOP) payments. OOP spending on health is dominated by the cost of Available online at: http://www.euro.who.int/__data/assets/ pharmaceuticals and this is currently pdf_file/0006/178053/HiT-Moldova.pdf Health Systems in Transition Vol. 14 No. 7 2012 a core focus of reform efforts.

The reform of health financing in the Republic of Moldova The publication was launched Republic of Moldova began in earnest in 2004 with the introduction of a mandatory Health system review on 22–23 November 2012 in health insurance (MHI) system. Since then, MHI has become Chisinau at the National Health a sustainable financing mechanism that has improved the Forum: “Healthy Moldova: Policies, technical and allocative efficiency of the system as well as Achievements and Opportunities”. • Silviu Domente Ghenadie Turcanu Erica Richardson overall transparency. This has helped to further consolidate Mircea Buga • The aim is for the Forum to the prioritisation of primary care in the system, which has become an annual event to been based on a family medicine model since the 1990s. support intersectoral working to Hospital stock in the country has been reduced since bring health into all policies. independence as the country inherited a Semashko health

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REVISING THE CLINICAL TRIALS DIRECTIVE: A VIEW FROM THE ENGLISH NATIONAL HEALTH SERVICE

By: Elisabetta Zanon

Summary: The Clinical Trials Directive has been highly criticised for contributing to a significant drop in the number of clinical trials conducted in the European Union (EU), with associated costs and the time taken to launch a trial almost doubling. To remedy these unintended consequences, the European Commission recently released proposals to amend the existing regulatory framework. The proposal for a new EU Regulation on clinical trials promises significant improvements to the current legal framework and is a clear attempt to streamline the rules in order to reduce the administrative burden and speed up time for the authorisation of new clinical trials.

Keywords: Clinical Trials, Research, Medicines, European Commission, NHS

Introduction participants, the ethical soundness of the trials, as well as the reliability and Clinical trials are studies on humans robustness of data generated. aimed at testing the safety and efficacy of medicines. They are essential to the While the Directive has significantly development of new medicines, and also improved the safety and ethical soundness have a role in the improvement of medical of clinical trials in the European Union care more generally, for example, through (EU), the harmonisation objective has trials comparing treatments or aiming to only been achieved to a limited extent, improve the use of medicines already on as Member States have interpreted the the market. Directive differently and have taken varied approaches to implementation. Many clinical trials involve multiple This has contributed to a considerable sites, including in several countries but increase in the administrative burden and historically, different Member States costs associated with clinical trials and, have developed diverse approaches to ultimately, has resulted in a significant regulating clinical trials. The Clinical drop in the number of clinical trials Trials Directive 1 aimed to address this applications in the EU. This has, in turn, by simplifying and harmonising the restricted innovation and reduced the administrative requirements for clinical competitiveness of clinical research in the Elisabetta Zanon is Director of the trials, while ensuring the protection of EU, with knock-on effects for patients’ NHS European Office, Brussels, the health and safety of clinical trials’ Belgium. Email: elisabetta.zanon@ access to new medicines and treatments. nhsconfed.org

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Table 1: Number of clinical trials applied for in the EU, 2007–2011 the need to be transposed into national law, and thereby ensuring that the 2007 2008 2009 2010 2011 rules for conducting clinical trials will 5028 4627 4619 4400 3490 be consistent across Europe.

The proposed Regulation represents a 3 Source: . Note: The data for 2011 is forecast on the basis of data available on 18 October 2011. significant improvement to the current regulatory framework and is one that should be widely welcomed. It is a clear Table 2: Number of planned subjects in clinical trials in the EU, 2007–2010 attempt to streamline the existing rules to reduce the administrative burden and 2007 2008 2009 2010 speed up time for the authorisation of new 544,287 410,568 367,036 408,294 clinical trials.

The NHS has been pressing for a revision 3 Source: of the existing Directive for a number of years and is pleased to see that the To address these shortcomings, One of the main criticisms has been that proposed Regulation reflects a number of following extensive consultation with the costs of conducting clinical trials have changes it has recommended. stakeholders on how to improve the EU increased significantly. The European law, the European Commission published Commission itself has recognised that Below we look in more detail at some of legislative proposals to amend the existing the number of staff needed for industry the proposed changes: Directive in July 2012. 2 sponsors (i.e., the organisation responsible for the trial) to handle the clinical trial Simplifying the authorisation process authorisation process has doubled, while The first significant amendment concerns for non-commercial sponsors the increase the application and authorisation most in administrative requirements has led to process before a clinical trial can start. a 98% increase in administrative costs. In Current rules require the submission of heavily criticised addition, the average delay in launching a separate application dossiers for each clinical trial has increased by 90% to 152 of the countries involved in a trial, piece of EU days, while insurance fees have increased often resulting in a disproportionate by 800% for industry sponsors. 2 administrative burden and delays in pharmaceutical the launch of clinical trials. The new These difficulties have contributed to Regulation proposes that a single legislation making the EU a less attractive location application dossier would be submitted to conduct clinical trials, which, in turn, via an EU portal. While all countries in As clinical studies become increasingly has resulted in a fall in clinical trial which the sponsor intends to conduct the important to the National Health Service activity in the EU. According to figures trial will be involved in the assessment of (NHS) in England, and to other health quoted by the European Commission in the application, they will have to cooperate care systems‘‘ around Europe, this article its own impact assessment on the revision in several areas of the process with one looks at the impact of the Clinical Trials of the Directive, and shown in Table 1, Member State leading and coordinating on Directive and at how some of the proposed the number of clinical trials applications their behalf. These changes are important changes could help to boost life sciences fell by around 25% from 2007 to 2011. and should reduce the bureaucratic research and improve patient care. In terms of the number of participants in burden, speed up the authorisation process clinical trials, as Table 2 shows, 2010 saw and reduce the lengthy delays that have Trials and tribulations over 135,000 fewer subjects planned to be hindered many clinical trials applications. enrolled in a trial compared to 2007, a fall As the European Commission has of around 25%. 3 A lighter regime for ‘low risk’ trials recognised, the Clinical Trials Directive Another positive proposal is the is arguably the most heavily criticised Regulating for change recognition that trials which pose no or piece of EU pharmaceutical legislation. very limited additional risk to participants Criticisms have been articulated by As mentioned previously, to respond compared to normal clinical practice a broad range of stakeholders and to these difficulties, the European should be subject to a lighter regulatory political actors such as patients, industry, Commission has released a proposal regime. The proposed Regulation academics, Member States and EU for new EU legislation. The proposal identifies a new category of clinical institutions for several years. takes the form of a Regulation, meaning trials, called ‘low interventional’, which that once agreed, the EU law will apply would be subject to more proportionate directly in each Member State, without rules for different aspects of the clinical

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trial process, including timelines for SUSARs are reported to the European the opportunity offered by this revision authorisation, monitoring, reporting, database. The proposed Regulation aims and to ensure that the new EU law is fit and insurance requirements. This is a to streamline and simplify these reporting for purpose by maintaining patient safety positive step forward especially for non- procedures by enabling direct reporting of while promoting high quality research and commercial bodies, such as universities SUSARs by the sponsor to the European improved patient care. and hospitals, which often sponsor non- database and the possibility to exclude commercial trials that aim to compare investigator-level reporting to sponsors if References the efficacy of medicines which are the protocol allows. Again, this proposal already authorised and for which there is certainly a welcome one, though more 1 European Commission. Directive 2001/20/EC exists extensive knowledge of their safety could be done to further streamline of the European Parliament and of the Council on the approximation of the laws, regulations and and tolerability. reporting requirements. administrative provisions of the Member States relating to the implementation of good clinical Enabling co-sponsorship practice in the conduct of clinical trials on medicinal The explicit introduction of the concept products for human use. Brussels, 4 April 2001. of co-sponsorship is also a very positive clinical Available at: http://ec.europa.eu/health/human-use/ clinical-trials/index_en.htm#rlctd development, particularly for non- commercial sponsors like universities trial applications 2 European Commission. Proposal for a Regulation and hospitals. These bodies often are of the European Parliament and of the Council on clinical trials on medicinal products for human use, unable to lead clinical trials on their own fell by around and repealing Directive 2001/20/EC. Brussels, 17 July due to different regulatory and practical 2012. Available at: http://ec.europa.eu/health/ difficulties and, therefore, decide to share 25% from 2007 human-use/clinical-trials/index_en.htm#rlctd the sponsor’s responsibilities with partner 3 European Commission. Staff working document, organisations to overcome these obstacles. to 2011 impact assessment report on the revision of the “Clinical Trials Directive” 2001/20/EC, Volume II. Compensation for damages The proposed Regulation will now pass Brussels, 17 July 2012. The proposed Regulation seeks to simplify through the EU legislative procedure, with the insurance compliance requirements negotiations between EU decision-makers for clinical trials. Current requirements expected‘‘ to last for several months before have created difficulties especially for the Regulation can be agreed. organisations sponsoring multinational trials in terms of their ability to obtain Conclusions insurance cover for clinical trials sites outside of their Member State. The The reform of the Clinical Trials new proposal attempts to tackle this by Directive was long overdue and after exempting from these requirements those extensive efforts by many health and trials that pose only negligible additional research bodies, including the NHS, it risk compared to treatment in normal is encouraging to see that the European clinical practice. More controversially, it Commission has listened to many of our proposes that each Member State sets up concerns and proposed a way forward. An a national indemnification mechanism, improved and streamlined EU regulatory working on a not-for-profit basis, to framework for clinical trials is essential help sponsors comply with insurance not only to boost Europe’s competitiveness requirements. This proposal is particularly but, most importantly, to improve the welcome by non-commercial sponsors. quality of health care which is provided to patients. Simpler safety reporting Researchers and ethics committees Research and innovation are becoming have long complained that the existing increasingly important for health care reporting arrangements for clinical trials systems. Looking at the English NHS are both onerous and inconsistent across specifically, NHS hospitals currently Europe. Presently, all reports of suspected sponsor around 500 clinical trials and unexpected serious adverse reactions virtually all our hospitals are involved in (SUSARs) related to a substance under some clinical research and recruit patients investigation have to be reported to the for clinical trials. national authorities and ethics committees in all the countries where a trial looking This Directive itself has been on trial at that substance is running. Each for much of the last decade. The English country is also responsible for ensuring NHS is committed to making the most of

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MEDICINES INNOVATION IN SEVERE MENTAL ILLNESS – THE NEXT INVESTMENT DESERT?

By: David J. Nutt and Jim Attridge

Summary: The societal burden of mental illness in Europe exceeds that of either cancers or cardiovascular diseases. Depression, anxiety and schizophrenia seriously impact upon the working age population and labour productivity. Despite past progress in developing effective medicines, many patients still do not respond and there are high levels of unmet need. Emerging basic science and product development technologies suggest that much scope exists for further incremental innovations. However in Europe, the ‘new economics’ of biopharmaceutical innovation and intense pressure on health budgets are driving a substantial decline in rewards for innovators. Unless more is done to protect funding of purchases of innovative medicines in this disease sector, the decline in investment will continue, creating another innovation desert analogous to that already seen for antibiotics.

Keywords: Medicines, Severe Mental Illness, Innovation Incentives

Gustavsson et al. estimated in 2010 that in research and development (R&D) the cost of mental illness in Europe was in better drugs for these conditions in €798 billion, consisting of 37% direct Europe is weakening. 2 This article reviews health care costs, 23% direct non- past progress and offers a prognosis of medical costs and 40% indirect costs and exciting scientific advances confronted productivity losses. 1 The EU per capita with growing short-termism in rewarding cost of brain disorders on average was innovation, driven by economic austerity. €1,550. This paper is limited primarily to depression, anxiety and schizophrenia, Innovation models for medicines in which constitute a substantial part of severe mental illnesses this cost and there is a growing literature showing the high negative impact of these The balance between static and dynamic David J. Nutt is Professor of illnesses upon labour productivity. competition determines the incentives to Neuropsychopharmacology, invest in R&D; government regulation Imperial College, London, UK and Vice-President of the European Enormous progress has been made in of markets sets this balance by providing Brain Council. Jim Attridge is a clinical models of severe mental illnesses ‘economic shelters’, such as patents. Visiting Research Fellow in The and biochemical brain mechanisms, Biopharmaceutical innovation involves Business School, Imperial College, London, UK. leading to the development of effective three competitive races: Email: [email protected] new drug treatments. However, investment

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The Research Race to discover new Figure 1: Classes of psychotropic medicines and their modes of action disease mechanisms and novel patentable Barbiturates agents for modifying them. GABA A Z-Drugs Selective BD1 Benzodiazepines Agonists 5-HT + NA Antagonists Antagonists The Development Race to convert the ANXIETY Tricyclic reuptake inhibitors patent knowledge into safe and effective products. Selective Serotonin reuptake inhibitors DEPRESSION 5-HT Antagonists The Market Diffusion Race to bring Classical MAOI’s Reversible MAOI’s these products into general use to benefit Chlorpromazine both patients and reward the innovators. PSYCHOSES Atypical Clozapine analogues Reserpine Dopamine, D2 Dual Dopamine, D2/5-HT2 Dopamine, D2 Antagonists Antagonists Stabiliser? Innovation theories distinguish between Halperidol Aripiprazole radical innovations and incremental ones. The first to market of a new class 1950 1960 1970 1980 1990 2000 2010 of treatment appears to be a radical innovation and follow-on products are Source: the authors. ‘incremental’ followers, but it may be one of these later entrants that offers the best treatment. This analysis reaffirms the established as the first line treatments for antipsychotics are the dopamine receptor reality that in practice innovation is an depression. Given they are exceptionally partial agonists, the first of which, incremental process and that classification safe in overdose, SSRIs are preferred to aripiprazole, does not cause Parkinsonism. of medicines as either ‘breakthrough’ the TCAs in the treatment of patients with or ‘me-too’ is a gross and unhelpful suicidal tendencies. Later clinical studies distortion. of manic and depressive episodes led to the definition of the new diagnostic sub-class 3 Progress in medicines for serious of ‘bipolar disorders’. mental illnesses dominant Anxiety is a normal emotion, but when Up until the 1970s, concepts of disease excessive, inappropriate or prolonged it paradigm is one states were vague, the numbers of can cause profound distress and functional people living with them greatly impairment. The benzodiazepines, of incremental underestimated, and there were few discovered in the 1960s, were the first treatments. Furthermore, those whose effective anti-anxiety agents and research improvements in condition deteriorated, or experienced on them continues even today. Not all psychotic conditions, were incarcerated, novel structural types blossom into treatments sometimes for life. Innovative progress successful drug families. The novel partial in three domains – clinical research, agonist buspirone has value in treating In summary, common patterns of progress laboratory studies and development of patients with general anxiety disorders, across the basic ‘‘research, clinical research new classes of medicines, in conjunction but substantial investment failed to find and product development domains with more widespread availability of more selective analogues. provides a choice of effective therapies psychotherapeutic interventions, has along with psychological interventions, transformed outcomes. The phenothiazine class of medicines were from which one, or more can be selected the first effective antipsychotic agents, but to suit individual patients, as shown in Effective therapy for depression began they cause ‘Parkinsonian-like’ side effects. Figure 1. with the monoamine oxidase inhibitors, Clozapine was patented in 1963, but it was which have serious side effects. Later twenty years later, when its exceptional The dominant paradigm is one of the tricyclic class of antidepressants efficacy in schizophrenia was recognised. incremental improvements in benefit (TCAs) were developed which had much It works exceptionally well, but has a very to risk ratios for new disease states and improved activity to side effect profiles. poor side effect profile. Despite many patient sub groups. Clinically, there However, individual patient responses years of study, we still have little idea as to remain significant cohorts of patients that varied greatly and many did not respond how it works; identifying this mechanism are resistant to all current treatments, or at all. Better definitions of disease states remains a major research goal. However, which, once stabilised, relapse, or become led to more accurate diagnoses and the improved analogues, such as risperidone, resistant to them. Figure 2 summarises selective deployment of this new choice of olanzapine and quetiapine, have become the complex relationships between therapies. The selective serotonin reuptake widely used. The latest developments in clinical conditions, modes of action and inhibitors (SSRIs) which followed were therapeutic agents. both highly effective and safe and became

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Innovation incentives Figure 2: Relationships between, neurotransmitters, classes of medicines and disease states Future investment will depend upon ‘technology push’ factors, technical regulatory standards and ‘market pull’ Neuro- transmitters Medicines Patient conditions factors. Benzodiazepines GABA A GAD Valium Librium GABA B OCD

Technology push factors ANXIETY SSRI’s Citalopram Panic 5-HT1 Fluoxetine There are new small molecule treatments Paroxetine SAD for anxiety and depression, for psychoses 5-HT2 PTSD and for bipolar disorders in phase II and Tricyclics III clinical development. However, if, due Noradrena-line receptors Imipramine Amitriptyline to poor prices most of these fail in EU

markets, it appears likely that there will be α1-Adreno receptors MAIO’s an even sharper downturn in longer-term SNRI’s BIPOLAR DISORDERS investment. Scope for further innovation Dopamine D1 Venlafaxine Dopamine D2 exists in the following three areas: Halperidols

Atypicals DEPRESSION Histamine H1/H2 Clozapine Variants of dopamine receptor partial Quietapine agonists in schizophrenia and mania Olanzapine Risperidone and modified reuptake blockers in PSYCHOSES depression could offer improved efficacy Chlorpromazine Lithium or tolerability, which are likely to Valproate improve patient outcomes through greater population uptake and sustained adherence Source: the authors. to treatment. Such developments could reduce the adverse effects of nausea and action may involve switching off memory Technical regulatory standards sexual dysfunction. In anxiety, improving circuits for bad memories in depression. understanding of the role of the GABA-A We have known for many years that Future innovations in mood disorder receptor should lead to drugs with less glutamate systems are dysregulated in the medicines will depend critically upon sedating and amnestic effects. schizophrenic brain, but only recently have whether less costly and time consuming glutamate-acting drugs for schizophrenia approval pathways are feasible. Concerns become safe enough to use. regarding the wide variation in Member States’ approaches to valuing innovations prices The search for genetic or physiological has led to suggestions that the European biomarkers for psychiatric disorders has Medicines Agency (EMA) should play are being levelled been on-going for many years. Brain a more prominent role at the outset by imaging, particularly magnetic resonance issuing with the product licence an EU down to those of imaging (MRI), has contributed much to assessment of the ‘relative efficacy’ of a our understanding of the brain regions new product, to improve the consistency of the cheapest involved in depression. Currently, national cost-effectiveness assessments. there is great excitement that the brain generics changes responsible for the action of Market pull factors antidepressants can be observed in The discovery of neurotransmitters, which normal volunteers, providing a way of Self evidently, there is a strong market pull regulate ‘sleep-wake’ cycles by promoting screening compounds at phase I clinical effect from patients with mood disorders arousal/awakefulness – the orexins – is trials, allowing pruning out of candidates for better treatments, but the EU economic leading to the invention of novel orexin ‘‘ earlier, with major cost savings. 4 Several crisis has led to multiple cost saving antagonists as sleep-promoting agents. molecular and structural abnormalities interventions by health systems, through High levels of stress hormones, especially have been reported for schizophrenia, price cuts, sweeping away the hoped cortisol receptor (crf), corticotrophin but no diagnostic test or other clinical for transition to a more orderly, Health and cortisol are found in many depressed application has yet emerged. 5 European Technology Assessment (HTA) – based people and new crf receptor antagonists biomarker research may yield ‘diagnostic- approach to pricing and reimbursement. targets are emerging for these disorders. therapeutic’ combinations for mood Prices are being levelled down within A remarkable discovery has been that disorders. 6 countries close to those of the cheapest the anaesthetic ketamine produces a generics, upon which are superimposed rapid elevation in mood in ‘treatment- cross-market price comparisons, which refractory’ patients. Its mechanism of

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now exploit the falling prices in poorer Across Europe, cheap generics have will continue to make, an immense social countries. In effect it is becoming a ‘race saved health care systems billions of and economic contribution, which dwarfs to the bottom’ for EU medicines prices euros, dramatically reducing revenues for the cost of these drugs. across the EU Member States. innovative companies. Projections suggest globally a further decline in revenues Future European policies and of circa €23 – 31bn, which will only be regulation partially offset by new products amounting more to circa €15 – 23bn. Revenues may decline Across EU health systems there is a by as much as 27%, while only 13% of severe cost convergence of thinking on rewarding new product revenues may be generated innovation around three precepts: from central nervous systems medicines. 7 saving measures Three factors are reducing investment in • Does it address an area of high unmet innovation; allowing generic competition medical need? will seriously from imported Indian and Chinese copy • To what degree is it a therapeutic products, supporting EU Member State damage innovation? cost containment and lowering R&D productivity. • Is it cost-effective today relative to incentives for current therapy at the price on offer? For health care systems more cost innovation savings will accrue from generics, but For severe mental illness drugs, 8 ‘‘ with greater risks of supply shortages. The exciting new ‘push’ factors have the exceptionally high uncertainties in Loss of some product development potential to drive a renaissance in mental predicting outcomes resulting from capabilities may increase exposure to disorder medicine innovation, but, if difficulties in making accurate diagnoses, resistant organisms, pandemics and the advances now in late development patient relapses, non-adherence and new disease states. In mood disorders, are not reimbursed at reasonable prices, non-responders makes it difficult to valuable inventions will not be translated investment in further product development determine what are the areas of unmet into useful products. The implications could dry up altogether by 2015, in a need, but health systems are signalling for EU competitiveness are likely to be manner similar to that observed for to innovators, that only if they achieve an export of more manufacturing and antibiotics in the 1990s. step-change advances in therapy in areas services jobs to Asia due to the upsurge of high unmet need will they be well in generic sales. Competition from Asia There are three domains in which policy rewarded. This is incompatible with an and the USA for inward investment in interventions might be made: incremental innovation process. innovative activities will intensify and 1. Invest more money in research to EU biopharma sector employment could However it is the third consideration, strengthen the ‘technology push’ fall by 50 –100,000 jobs. cost-effectiveness, that heralds the most 2. Lighten the regulatory burden in significant driver of change. Innovation development by streamlining processes. is a continuous process and real world Conclusions and recommendations experience in clinical practice plus 3. Protect innovators from yet more Public health systems and industry further product developments commonly arbitrary price cutting initiatives business models are at a point of transforms the potential value during discontinuity. the early years of a product’s market life. A holistic view of all three of these is Comparative HTA methods can seriously needed in formulating future policies. Health policies implicitly assume that disadvantage new medicines for mental It is not enough to frame EU policies if there are established treatments illnesses, because building quantitative solely upon supply side factors. The for diseases, such as anxiety and models, with high levels of indirect EU Innovative Medicines Initiative depression, this is synonymous with costs and uncertain patient responses, (IMI) and collaborative ‘government- them having relatively low levels of is exceptionally challenging. Innovators industry’ schemes are making a unmet need. Popular rhetoric persists in bringing forward incremental advances valuable contribution. The Orphan naive distortions that new products are for anxiety, depression and schizophrenia Drug programme has strengthened either true innovations of great value, must either concede that the product is investment in drugs for rare diseases but or worthless me-too’s. When a broader derivative of an existing class and then the future burden of ‘relative efficacy’ view is taken of the economic, as well as justify a massive price uplift over the cost assessments at the EU level and national clinical consequences of unmet need in of existing generic therapies, or they have cost-effectiveness assessments militate mental illness in the working population, to persuade purchasers that it should be against faster, less costly pathways to this is a faulty judgement. The full added exempt from such clustering methods and market. Further ‘push’ incentives and value of innovative medicines can only be negotiate a ‘managed entry’ contract. streamlining of EMA processes alone will understood in retrospect. For example, the not reverse the decline in investment for SSRI’s antidepressants have made, and

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mood disorders, in particular, without a the question, ‘Can Europe afford not to 7 Charles River Associates. Innovation in the more concerted pan-European initiative to invest in, and reward well, innovation to Pharmaceutical Sector: A study undertaken for the address damaging demand side policies. improve the mental health of its citizens’? European Commission. London: Charles River Associates, 2004. Available at: http://ec.europa. eu/health/files/pharmacos/docs/doc2004/nov/ Successful innovative industries are the References eu_pharma_innovation_25-11-04_en.pdf key to restoring competitiveness and 8 Kotseki A. Pharmacies face seemingly endless 1 Gustavsson A, Svensson M, Jacobi F, et al. Cost growth for Europe, but more severe cost medicines shortages, Greek Reporter, 7 June 2012. of disorders of the brain in Europe 2010. European saving measures will seriously damage Available at: http://greece.greekreporter.com Neuropsychopharmacology, 2011;21(10):718–779. the incentive for innovation investment 9 Geoghegan-Quinn M. Promoting Innovation in 2 Nutt D, Goodwin G. ECNP Summit on the and drive investment out of Europe to an Age of Austerity: the European Dimension. In: future of CNS drug research in Europe. European the USA and Asia. Máire Geoghegan- Tilford S, Whyte P (eds.) Innovation – How Europe Neuropsychopharmacology 2011;21:495–499. Quinn, EU Commissioner for Research, Can Take off. London: Centre for European Reform, Innovation and Science recently 3 Cuthbert B, Insel T. The data of diagnosis: new 2011:43–48. 9 approaches to psychiatric classification. Psychiatry emphasised :- 10 Cueni T. Can Europe afford innovation? Eurohealth 2010;73:311–314. 2008;14:8–10. ‘All Member States are currently 4 Harmer CJ, Shelley NC, Cowen PJ, Goodwin GM. working to reduce their budget Increased positive versus negative affective perception and memory in healthy volunteers deficits and to keep public debt levels following selective serotonin and norepinephrine under control. While this process is reuptake inhibition. American Journal of Psychiatry necessary, it is critical that budget cuts 2004;161(7);1256–1263.

be implemented in a way that supports 5 Perlis RH. Betting on Biomarkers. American sources of future growth’. Journal of Psychiatry 2011;168(3):234–236.

The question has been posed, ‘Can 6 Schmidt HD, Shelton RC, Duman RS, Functional Europe Afford Innovation’? 10 In the face biomarkers of depression: diagnosis, treatment of the escalating social and economic and pathophysiology. Neuropsychopharmacology 2011;36:151–154. costs of mental disorders in Europe and the promising technological advances described here, we would conclude with

New HiT for Kazakhstan financing system was set up that included pooling of funds at the oblast level, establishing the oblast health department as the single-payer of health services. Since 2010, resources for By: A Katsaga, M Kulzhanov, M Karanikolos and B Rechel hospital services under the State Guaranteed Benefits Package Copenhagen: World Health Organization 2012 have been pooled at the national level within the framework (acting as the host organization for, and secretariat of, the of implementing the Concept on the Unified National Health European Observatory on Health Systems and Policies) Care System.

Number of pages: 154, ISSN 1817-6127 Vol. 4 No. 4 Kazakhstan has also embarked on promoting evidence-based medicine and developing and introducing new clinical practice Available online at: http://www.euro.who.int/__data/assets/ guidelines as well as facility-level quality improvements. pdf_file/0007/161557/e96451.pdf However, key aspects of health system performance are still in dire need of improvement. One of the key challenges is regional Since becoming independent, Kazakhstan has undertaken inequities in health financing, health care utilisation and health major efforts in reforming its post-Soviet health system. outcomes, although some Two comprehensive reform programmes were developed Health Systems in Transition Vol. 14 No. 4 2012 improvements have been achieved in the 2000s: the National Programme for Health Care in recent years. Despite recent Reform and Development 2005–2010 and the State Health Kazakhstan investments and reforms, however, Care Development Programme for 2011–2015 “Salamatty Health system review population health has not yet Kazakhstan”. Changes in health service provision included improved substantially. a reduction of the hospital sector and an increased emphasis on primary health care. However, inpatient facilities continue • Maksut Kulzhanov Alexandr Katsaga • Bernd Rechel to consume the bulk of health financing. Partly resulting from Marina Karanikolos changing perspectives on decentralisation, levels of pooling kept changing. After a spell of devolving health financing to the rayon level in 2000–2003, beginning in 2004 a new health

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DEVELOPING REFERENCE NETWORKS FOR EUROPE: MOVING PATIENTS OR KNOWLEDGE?

By: Willy Palm, Irene A. Glinos and Bernd Rechel

Summary: After more than ten years of heated debate a European directive was finally adopted in March 2011 that established a legal framework for cross-border health care within the European Union. In addition to setting out rules for providing and reimbursing cross- border health care, the Directive also aims to promote cooperation between Member States, including through the development of European reference networks. With less than one year until the entry into force of the Directive in October 2013, the European Commission is preparing criteria and conditions for such reference networks.

Keywords: Cross-border Health Care, Cooperation, Reference Centres and Networks, EU Law, Specialised Care, Rare Diseases

An old idea, a broad concept initiatives be mapped and their scope further explored, along with the use The idea of creating – or rather identifying of cohesion and structural funds. Not – centres of clinical excellence in Europe surprisingly, the first policy initiatives was already raised many years ago when were taken in the field of rare diseases. It the phenomenon of patient mobility was the Task Force on Rare Diseases that started to make its way onto the EU produced the first overview in 2005 and health agenda. It was not only seen as defined a range of criteria that centres of an interesting avenue for developing a reference should comply with to obtain conscious, proactive policy towards cross- European recognition. This was followed border care but also as a way of saving by various pilot projects on specific rare costs and improving quality for complex diseases, which received financial support medical interventions or indications under the EU’s public health or research by sharing resources between Member framework programmes. 2 States. 1 In an era of increasing clinical Willy Palm is Dissemination specialisation, hospitals were also self- To some extent, the initial focus on rare Development Officer and Irene proclaiming their excellence in specific A. Glinos is Researcher at the diseases contributed to another significant areas to extend their catchment areas, European Observatory on Heath development: the gradual shift from Systems and Policies, Brussels, even beyond national borders. Belgium. Bernd Rechel is Senior identifying individual European centres Researcher at the European of reference (ECRs), which, based on In 2003, the High Level Reflection Observatory on Heath Systems their specific equipment and/or expertise Process (HLRP) on patient mobility and and Policies, London School of could treat patients from all over Europe, Hygiene and Tropical Medicine, UK. health care developments in the European towards the creation of European reference Email: [email protected] Union (EU) recommended that existing

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networks (ERNs) which would connect objectives or motivations by specifying support and knowledge transfer between different centres to share knowledge a range of eight different objectives of Member States and centres in the same and expertise in diagnosing and treating which ERNs need to embody at least three clinical field. complex cases. This accommodated the (Article 12.2). Whereas initially the idea idea that the EU, rather than organising of ERNs seemed to be inspired by the Building on national practices the mobility of patients through labelling objective of improving cost-effectiveness expert centres, should instead promote through concentrating resources across In order to be successful, ERNs need to mobility of knowledge and information. borders, it increasingly became motivated reflect and build on existing practices in by the desire to improve safety and Member States. Although the concept of quality through concentrating cases, reference centres and networks is known raising standards and even integrating in most European health care systems, a Improve care. Equity also plays a role, since review of experiences in 20 EU Member reference networks might give Member States and Norway found substantial access to highly States, whose limited patient numbers or variation, not only in the scope and resources make investing in the necessary motivations for developing them, but also specialised care equipment and infrastructure difficult, in their state of progress and political access to highly-specialised services for importance. 4 Despite these developments, the concept of their populations outside of the national European reference networks (or centres) territories. Based on the review five key dimensions was never meant to be restricted to the can be distinguished in the establishment particular area of rare diseases nor was In setting the framework within which the and functioning of reference centres and it focused entirely on moving knowledge Commission is now requested to define a networks (see Figure 1): instead of patients. The HLRP noted that more detailed list of criteria and conditions • The way they are organised and any system of ECRs should be flexible, for ERNs and providers wishing to join governed; objective,‘‘ transparent and leave choices them (Article 12.4), the Directive also as to its use open to the responsible applies an open and integrative approach. • The purpose or motivation for their authorities. Even if the EU promoted the Rather than exclusively focusing on development; idea that expertise rather than patients the clinical excellence that is naturally • Their function (what they do); should travel, it was recognised that both expected from ERNs in the actual aspects could not – and should not – be diagnosis and treatment of patients, • Their material scope (what type of dissociated from each other. Partners the Directive recognises that expertise patients/conditions/care they focus on); within the networks, by disseminating should also be reflected in a broader • Their geographical scope. information and developing guidelines range of aspects: a multidisciplinary and on state-of-the-art treatment for specific coordinated approach; special attention While several European countries have conditions, would particularly attract to evaluating outcomes and controlling not yet officially embraced the concept of patients from countries where this quality; strong links with medical reference centres or networks, a growing expertise is lacking. training and research, and an active number of countries have in recent role in developing standards and best- years initiated specific regulation and practice guidelines. In addition, good European reference networks under frameworks for establishing reference communication skills and the involvement the Directive centres or networks, sometimes under the of patients and patient groups are regarded direct influence of the Cross-border Care The concept of ERNs as specified under as key features for recognising reference Directive. Most often, this was motivated the Cross-border Care Directive 3 follows networks, as well as their willingness by the need to concentrate the provision this broad approach. In its preamble, the to collaborate closely with other centres of highly specialised services in a limited Directive suggests that “all patients who and networks. number of medical institutions. Some have conditions requiring a particular countries also have “de facto” systems, in concentration of resources or expertise” In fact, by focusing on networks rather which certain hospitals or departments – could benefit from providers networking than centres and by emphasising the mostly teaching hospitals – have become to improve access to high-quality and cost- multifaceted approach and openness the leading centres to which the most effective care (Recital 54). Cooperation to sharing and collaborating, the complex and severe cases are referred in the field of ERNs and rare diseases is Directive avoids the trap of being because of their traditional position developed in Articles 12 and 13. dragged into a spiral of competition or recognition among professionals. between clinical institutions to become However, proper referral rules, designation Article 12 rather than providing a real the top reference centre in Europe. criteria and systematic quality assessment definition for the concept of ERNs, lists On the contrary, networking supports are often lacking. their objectives and the criteria they the goals of benchmarking, mutual should fulfil. It leaves room for different Gradually, in many countries more formal types of networks pursuing different systems are being set up. Partly due to the

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Figure 1: Dimensions to define reference centres and networks community governments. Following a qualification process in which each centre is audited by the SNS’s Quality Agency, Governance Objectives Function Condition Area the designation committee proposes the centres for nomination to the Ministry • Formal • Efficiency • Referral of • Prevalence • EU-wide of Health. The designation is awarded patients • Informal • Quality • Cost • Trans-national for a maximum period of five years. • Safety • Complexity • National The RCDUs are monitored annually. An • Peer structure • (Equity) • Inter-regional information system gathers data on the • Hub & spokes • Rare • Regional procedure and the outcome indicators • Organic • Market • Critical included in the designation criteria. position • Transferring • Chronic knowledge • Common To date, 46 priority diseases and procedures have been identified and the

Source: Palm W, Glinos I A, Rechel B, Garel P, Busse R, Figueras J (Eds.) Building European Reference Networks. Exploring designation criteria for thirteen areas concepts and national practices in the EU. Observatory Studies Series 28; (forthcoming 2013). of specialisation have been defined. Up to 2011, 132 reference centres, departments and units of the SNS had been designated effects of the financial crisis, countries and prices of provided services, giving rise for 35 diseases and procedures. have stepped up efforts to rationalise and to provider-induced demand. Therefore it Nearly 90 of them are monitored through reconfigure hospital care, categorising is important to establish objective, detailed the information system. The care provided their hospitals into distinct levels that and transparent procedures, with the by the RCDUs is mainly funded through a specify their remit both in geographical involvement of all relevant actors. national cohesion fund. terms and in the types of care to be provided. Although the need for a more Some European countries have developed However, not all approaches to reference centralised and structured provision of well-established systems and procedures networks require a general planning specialised hospital services is generally for defining and designating reference process. Concentration of specialised justified in view of benefits for efficiency, centres and networks, as well as for services and referral of patients can also cost-effectiveness, quality and equity, monitoring their activities and outcomes. be achieved through minimum activity it sometimes also faces criticism and A good example is Spain. Since 2006 the thresholds, as for instance applied in distrust. country has elaborated a joint planning Germany, or through special agreements system for concentrating specific or contracts between statutory health In Central and Eastern European specialised services in reference centres, insurance bodies and a range of reference countries, centralisation efforts may departments and units (RCDUs) of the centres that specialise in the treatment evoke memories of the old Shemasko National Health Service (SNS). Under the of specific rare or chronic diseases, as in model, which provided only limited supervision of the SNS’s Interterritorial the case of Belgium. In addition, quality choice for patients. In decentralised Council, a special designation standards and certification processes can systems, centralisation may be perceived committee, in which the Autonomous be used as tools to define and impose the as an attempt by the central level to gain Communities and the Ministry of level of expertise and multidisciplinary more control over the health system. Health are represented,* identifies the approach that is expected from reference In some cases, it is even argued that priority diseases and procedures for centres and networks for the treatment of the designation may actually impede which concentration is desirable. This rare and complex cases. collaboration between hospitals. Whereas can be either motivated by the use of such negative perceptions most often come very advanced technologies (e.g., total For what conditions? from providers who are questioning or skin electron radiation), the involvement challenging the designation, providers are of a high level of specialisation or the One of the important challenges that EU sometimes also the biggest proponents. low prevalence of cases (rare diseases, and national regulators are facing is how Obviously, their interest in the concept transplants). Reference services can only to define the scope for reference centres may not always be in accordance with be established for treatments that are part and networks. Similar to the EU policy health system objectives, but based on of the publicly funded basket of health processes described above, rare diseases more business-oriented motivations and care services. With the help of a group of are clearly a prime focus for developing the need to seek a return on investment experts the designation criteria are defined the concept of reference centres and for highly specialised equipment through for each area of specialisation. The actual networks also at Member State level. consolidating their market positions or selection of RCDUs is made on the basis Several countries recognise centres for even extending their catchment areas. of centres proposed by the autonomous specific rare diseases and have established The danger here is that without any clear national networks, often built around a framework the concept is used to increase * In Spain, the regions, known as Autonomous Communities, central coordination centre. The Italian patient expectations, as well as the scope are responsible for managing the regional health system and National Network for Rare Diseases, delivering health care.

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established in 2001, is coordinated by disorders, aimed at improving care of centres as part of ERNs may have, 5 the National Centre for Rare Diseases through information, research and it could be important to constrain their (part of the National Health Institute) and patient participation. scope and expectations and develop a links certified care providers who were gradual approach in designating European mandated by regional authorities. France reference networks. adopted a National Plan for Rare Diseases in 2004, which included a designation goals of To enable the development of ERNs, the procedure for reference centres for European Commission is required to adopt specific or groups of rare diseases. The benchmarking, a Delegated Act that defines the criteria Czech Republic, Belgium and Malta are that ERNs and health care providers developing similar strategies. mutual support wishing to join them have to fulfil. To support and advise the Commission, a Furthermore, in areas of critical and and knowledge Cross-border Health Care Expert Group complex conditions similar plans for was established with representatives centralising and networking are being transfer from Member States. In addition, in late implemented. Examples can be found in November 2012 the Commission launched the fields of transplants, burns, trauma This wide variety of national practices a public consultation, inviting stakeholders and stroke care. The concept also has illustrates that prevalence of conditions to give their views on the criteria for considerable appeal in the field of cancer. is just one, and not necessarily the most selecting diseases or conditions suited for Countries are setting up reference centres relevant, indicator that justifies the setting creating ERNs, and for determining which ‘‘ 6 in oncology, not only to address some rare up of ERNs. The question of whether there centres can join them. In a next phase the cancers but also to improve the quality of is sufficient critical mass within a country Commission will adopt an Implementing care and to ensure speedy uptake of new or a region to address rare diseases Act for establishing and evaluating the therapies. In some cases, these networks depends not only on the size of the country ERNs as well as facilitating the exchange are less focused on the actual provision (after all, the European definition of rare of information and expertise. of care but rather on the idea of sharing diseases still results in about 30,000 cases knowledge and best practice, as well as the in the UK alone): available expertise and To come up with a system of criteria that coordination of training and research. treatment capacity are also highly relevant. is clear, pertinent and perceived as fair Prevalence alone fails to indicate the type and that can work in 27 different national This further extends the scope to chronic of disease; how well established treatment settings is not an easy task. After all, the conditions (e.g., diabetes) as they can also options are; what is required in terms of difference in Member States’ approaches benefit from this kind of networking. In interventions and support; or whether it to reference networks and centres is just a Germany, the Competence Networks in involves a short period of treatment or reflection of the diversity between health Medicine, initiated at the end of the 1990s, ongoing care. systems in Europe. promote horizontal collaboration between research institutions to stimulate Next steps References innovative medical therapies in specific areas of disease (e.g., mental health, From the national experience, it is clear 1 Communication from the Commission. Follow-up Parkinson’s disease, dementia, specific that also at EU level there are important to the high level reflection process on patient mobility and healthcare developments in the European Union, cancers, rare diseases), as well as vertical challenges to ensuring that the various COM/2004/0301 final, 20 April 2004. integration with medical specialists to (potentially competing) regional, national 2 accelerate transfer into practice. Another and international concerns are reconciled, See: Report of the EU Committee of Experts on Rare Diseases (EUCERD), February 2011. good example are the five Hospital- not least when it comes to selecting the University Institutes (IHU) in France, potential centres to be part of the ERNs. 3 Directive 2011/24/EU of 9 March 2011 on the a collaboration mechanism between In addition to involving national and application of patients’ rights in cross-border healthcare, Official Journal, 4 April 2011, L88/45 – 65. tertiary care hospitals and universities, regional health authorities in reviewing involving teams of renowned biomedical and assessing candidate centres, it is 4 Palm W, Glinos I A, Rechel B, Garel P, Busse R, researchers involved in education and equally important to use detailed and, Figueras J (Eds.) Building European Reference Networks. Exploring concepts and national practices in translational research. Smaller interesting objective criteria, as well as having good the EU. Observatory Studies Series 28, forthcoming examples include the Dutch ParkinsonNet, monitoring and information systems 2013. coordinating regional networks of closely in place. Since on some occasions the 5 See: Baeten R, Jelfs E. Simulation on the cooperating specialised professionals, expertise and willingness to share EU cross-border care Directive. Eurohealth and the Alliance for Heredity Issues knowledge can be specifically linked 2012;18(3)18 – 20. (VSOP), also in the Netherlands, which to the presence of certain individual 6 Public consultation on the implementation of is run by organisations of parents and specialists, it is important to perform European Reference Networks (ERN) web page. patients with rare, genetic and congenital periodical re-assessments of designated European Commission. Available at: http://ec.europa. centres and networks. Moreover, given the eu/health/cross_border_care/consultations/ financial implications that the labelling cons_implementation_ern_en.htm

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FINALLY ON TRACK? HEALTH REFORMS IN KAZAKHSTAN

By: Alexandr Katsaga, Maksut Kulzhanov, Marina Karanikolos and Bernd Rechel

Summary: Since 2005 Kazakhstan has embarked on two comprehensive national reform programmes. These have aimed to change the provision and financing of care, place more weight on prevention, and improve the quality of care. Key changes to health care provision included the standardisation of health services and the development and implementation of clinical practice guidelines. Health financing reforms have seen the introduction of pooling at the national level (for hospital services under the State Guaranteed Benefits Package) and the oblast level (for primary health care services). However, there are still challenges in the implementation of reforms and population health indicators lag behind those of most other former Soviet countries.

Keywords: Health System Reforms, Health Care Financing, Health Care Delivery, Kazakhstan

Introduction already highlight the enormous challenges faced by Kazakhstan’s health system. Our Due to its booming energy sector, article, based on the recently published Kazakhstan is by far the richest of health system review, 2 aims to provide an the Central Asian states that became overview of recent health reforms in the independent with the dissolution of the country and of the challenges that remain Soviet Union in 1991. Despite a reduction for the future. in Gross Domestic Product (GDP) between 2008 and 2009 resulting from the global economic crisis, Kazakhstan’s Recent reforms economy has rebounded and its GDP Similar to other countries in the region, per capita in 2011 was at least four times Kazakhstan inherited an oversized and Alexandr Katsaga is a freelance higher than that of the poorest Central inefficient health system from the Soviet international consultant, Maksut Asian countries – Kyrgyzstan, Tajikistan Kulzhanov is Director General of period, with too much emphasis on bed and Uzbekistan – and 50% higher than in the Republican Centre for Health and staff numbers. 3 Initial health reforms Development and President of Turkmenistan. 1 the National Health Chamber, in the country after independence were Kazakstan, Marina Karanikolos and chaotic and volatile. Factors that impeded Yet, paradoxically, many of Kazakhstan’s Bernd Rechel are Researchers at progress in health reforms included a health indicators lag behind those of the European Observatory on Health general lack of trained administrative Systems and Policies, London other countries in the former Soviet and health management personnel School of Hygiene and Tropical Union. Life expectancy at birth in 2010, Medicine, London, UK. and frequent organisational changes. at 68.6 years, was one of the lowest in the Email: [email protected] Beginning in 1996, the Ministry of WHO European Region. 1 These numbers

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Health changed its internal structure performance-based payment mechanisms, to 18 years old and women of reproductive several times, with Ministers of Health and a strengthening of continuous quality age to free outpatient pharmaceuticals. and their teams changing on average improvement processes. 6 Insufficient financial protection is an issue every two years. In 1999 the Ministry of for part of the population, with 7.4 % not Health was abolished as an independent Health financing reforms using health services in 2008 because of administrative body and subsumed under Initial health financing reforms in high costs. 2 larger ministries, only to be restored the 1990s and early 2000s were erratic. in 2002. In 1996, the national Mandatory Health Health service provision reforms Insurance Fund was set up, operating as a Similar to other countries of the former parallel structure along with the previous Soviet Union, the provision of health system of funding health organisations services in Kazakhstan has evolved out-of- through the state budget, which resulted on the basis of the legacy of the Soviet in the vertical fragmentation of pooling. health system, with its overemphasis on pocket Due to revenue shortfalls, corruption, hospital services and its neglect of primary and the impact of the Russian financial health care, disease prevention and health payments crisis in 1998, the national health promotion. This delivery system is still in insurance system was discontinued the the process of being reorganised. constitute 40.1% same year and Kazakhstan returned to budgetary financing. However, problems Health care provision and financing of health of horizontal fragmentation emerged have been largely devolved to the in 2000–2003, when, in line with broader oblast administrations and their health expenditure administrative decentralisation, health departments. The 14 oblast and Almaty financing and administration were and Astana city health departments are the Major changes in the structure and decentralised to the rayon level. These key bodies administering health services regulation‘‘ of the health system were changes resulted in the creation of in Kazakhstan and run most hospitals and initiated in the mid-1990s, ranging inefficient and poorly manageable micro- polyclinics. In addition, parallel health from attempts to devolve power to the health systems, negatively impacting systems run by some ministries and rayon (local) level to the introduction on the overall efficiency of the health government agencies have been inherited of mandatory health insurance and the system and the population’s access to from the Soviet period and are still largely restructuring of primary health care. health services. in place. However, not all of these envisaged changes were implemented and some, such Beginning in 2004, a new health financing Although Kazakhstan was the setting as the experiment with mandatory health system was set up that, following similar of the Alma-Ata Declaration of 1978, insurance, were reversed. More consistent reforms in neighbouring Kyrgyzstan, 7 which emphasised the centrality of and coherent reforms only came about allowed pooling of funds at the oblast primary care to the operation of effective, in the second half of the 2000s, when (regional) level, establishing the oblast efficient and equitable health services, 8 two comprehensive reform programmes health department as the single-payer this principle was neglected for a long were adopted: the National Programme for health services. Health purchasing time, with a higher priority allocated of Health Care Reform and Development mechanisms were also reformed, to inpatient facilities. In the 1990s a for 2005–2010 and the State Health Care establishing capitation payment for dramatic reduction of outpatient services Development Programme for 2011–2015. primary health care, a case-based payment occurred, following the introduction of These programmes greatly stabilised system for hospital care, and a partial user fees for most diagnostic services the previously fluid health policy fund-holding system for outpatient and the necessity to purchase outpatient environment. specialty care. Since 2010, resources pharmaceuticals. This situation changed for hospital services under the State significantly in the 2000s, when primary In 2009 two key health policy documents Guaranteed Benefits Package have been health care facilities were legally and were adopted that aimed to underpin pooled at the national level. financially split from hospitals, providing further reforms: the Code on People’s them with greater autonomy to manage Health and the Health Care System 4 However, as in other countries of the their resources and increase efficiency. and the Concept on the Unified Health region, out-of-pocket payments (coming Furthermore, the infrastructure of primary Care System. 5 Both documents envisage from official user fees and informal under- health care was upgraded, particularly country-wide measures for improving the the-table payments) are another important in rural areas. However, the shortage of health of the population, with a particular source of revenue, constituting 40.1% qualified personnel remains one of the emphasis on prevention and the shared of total health expenditure in 2010. 1 major problems in this sector. Rural and responsibility of the state and individuals Recognising that this presents a major remote areas continue to experience a for health. The Concept on the Unified barrier to accessing services, an outpatient shortage in primary care personnel, while Health Care System envisages the free drug benefit has been introduced larger cities are much better staffed. There choice of providers, the introduction of that entitles children, adolescents up

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is also an imbalance towards specialist Main challenges for the future Finally, quality of care has been services, to the detriment of primary recognised as another area in need of As this brief overview has highlighted, health care facilities. major improvement and Kazakhstan has there are still many elements of embarked on promoting evidence-based Kazakhstan’s health system that need to be In the hospital sector, Kazakhstan has medicine and developing and introducing developed further. Crucially, the ultimate significantly reduced the number of new clinical practice guidelines based on objective of the health system – improving hospitals and hospital beds and also started WHO standards, as well as facility-level the population’s health – has not yet been to renew its health infrastructure, but the quality improvement. Preliminary results sufficiently achieved. While information ratio of hospital beds per capita is still high of the State Health Care Development on mortality amenable to health care and also differs greatly across oblasts. Programme 2005 – 2010 indicate progress interventions is not readily available, Furthermore, inpatient facilities continue in quality improvement, in particular with five-year survival rates for patients with to consume the bulk of health financing. regard to maternal and child health and a primary diagnosis of cancer are low, In 2008 public expenditure on hospital tuberculosis, but also a strong need for amounting to 50.2% in 2009. 2 care was 2.6 times higher than expenditure further efforts. on outpatient services and only 0.17% of One of the main areas of future efforts oblast health expenditure was devoted to will have to be stepping up public health References health promotion. 2 and primary health care. The allocative 1 European Health for All Database, August 2012 efficiency of Kazakhstan’s health system Quality of care was another focus of version. Copenhagen: World Health Organization is undermined by a continued reliance on Regional Office for Europe, 2012. reform efforts. After 2005 the principles inpatient care, which consumed 53.4% 2 of evidence-based medicine were Katsaga A, Kulzhanov M, Karanikolos M, Rechel B. of total public expenditure on health increasingly introduced to policy-makers, Kazakhstan: Health system review. Health Systems in in 2008, whereas primary health care only Transition, 14(4);2012: 1–154. academics and health care providers, 2 received 16%. There is also much scope 3 leading to a gradual recognition of Rechel B, McKee M. Health reform in central and for improving technical efficiency, in evidence-based medicine as a core eastern Europe and the former Soviet Union. The view of a high ratio of hospital beds per Lancet 374;2009: 1186–95. prerequisite of clinical practice, education population, poor performance indicators 4 and research, and of the importance of its President of Kazakhstan. Code on People’s Health for inpatient care, and many narrowly institutionalisation and implementation. and the Health Care System, Presidential Degree specialist health facilities. No. 193-IV, 18 September 2009. Almaty. The Health Care Development Programme 2011–2015 envisages a 5 Ministry of Health. Concept on the Unified Health Financial protection of the population is comprehensive set of measures to improve Care System. Astana: Ministry of Health, 2009. another area that requires more attention, the efficiency and quality of hospital care. 6 President of Kazakhstan. State Health Care as widespread out-of-pocket payments Key areas include improving hospital Development Programme for 2011–2015. Salamatty undermine access to services. There are performance, development of general Kazakhstan, Decree of the President of the Republic also pronounced regional inequities in of Kazakhstan No. 1113, 29 November 2010. Almaty. hospitals with specialty departments, and health financing, health care utilisation 7 expansion of diagnostic and treatment Rechel B, Ahmedov M, Akkazieva B, Katsaga A, and health outcomes, although some technologies. Khodjamurodov G, McKee M. Lessons from two improvements have been achieved in decades of health reform in Central Asia. Health recent years. Residents of Almaty and Policy and Planning 27(4);2012: 281–87. Another challenge is that linkages between Astana cities still have advantages in 8 primary and secondary care are poor, and World Health Organization. Declaration of accessing health services, as these two Alma-Ata, International Conference on Primary many services are organised in parallel cities host the most advanced national Health Care: Alma-Ata, 6 –12 September, 1978. vertical structures, such as tuberculosis clinical centres, whereas the geographical Available at: http://www.who.int/hpr/NPH/docs/ services, sanitary-epidemiological declaration_almaata.pdf accessibility of health services in remote services, or the health systems operated 9 areas is much more challenging, due to Ministry of Health. Ministry of Health Order by other ministries and government the country’s vast and sparsely populated No. 796 of 26 November 2009 on Approving Types agencies. The resulting poor horizontal and Volumes of Health Services. Astana, Ministry of territory. In 2010 life expectancy at birth integration of services leads to duplication Health, 2009. varied between 66.3 in North-Kazakhstan and inefficiencies. In light of this, the oblast and 73.2 in Astana city. There were standardisation of health services across also strong regional variations in infant the country is one of the key objectives and maternal mortality. 2 pursued by current health reforms. In 2009 the Ministry of Health approved standardised types and volumes of health services at five levels of care. 9

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NEW PUBLICATIONS

New HiTs for the United Kingdom (Northern Ireland, New HiT for Scotland Scotland and Wales)

The new HiTs (Health Systems in Transition) reviews for the By: D Steel and J Cylus United Kingdom (Northern Ireland, Scotland and Wales) Copenhagen: World Health Organization 2012 (acting as the host have just been released and were officially presented at organization for, and secretariat of, the European Observatory on the King’s Fund Annual Conference in London Health Systems and Policies). on 28 November 2012. Number of pages: 150

ISSN: 1817-6127 Vol. 14 No. 9 New HiT for Northern Ireland Available online at: http://www.euro.who.int/__data/assets/ pdf_file/0008/177137/E96722.pdf By: C O’Neill, P McGregor and S Merkur Since devolution in 1999, the Scottish Parliament and Government Copenhagen: World Health Organization 2012 (acting as the host have been responsible for most areas of domestic policy, including organization for, and secretariat of, the European Observatory on the health system. Health Health Systems and Policies). services in Scotland are financed Health Systems in Transition Number of pages: 91 Vol. 14 No. 9 2012 almost entirely out of general taxation, are largely free at the ISSN: 1817-6127 Vol. 14 No. 10 point of need and available to all United Kingdom Available online at: http://www.euro.who.int/__data/assets/pdf_ (Scotland) inhabitants. There is a very file/0007/177136/Northern-Ireland-HiT.pdf Health system review small independent health care sector, both private and Northern Ireland has an integrated health and social care system non-profit-making. and since the establishment of a devolved administration a locally The Scottish health system elected Health Minister now • Jonathan Cylus David Steel has increasingly diverged leads the publicly financed Health Systems in Transition from the health system Vol. 14 No. 10 2012 system. The Minister has in England over the past considerable power to set policy decade. Scotland has and, in principle, to determine United Kingdom pursued an approach (Northern Ireland) the operation of other health stressing integration and Health system review and social care bodies. The partnership among all parts of its national health service organisation of the National (NHS) as opposed to an English approach which, in part, is Health Service (NHS) in driven by market forces. Comparatively fewer organisational and Northern Ireland is radically structural changes, in addition to consistent policy objectives, Ciaran O’Neill Pat McGregor different to that in England, Sherry Merkur have provided a strong launching pad for achieving improvement despite superficial similarities. in health services, as well as in the health status of the population. A crucial difference is the In addition, substantial increases in funding have led to significant commissioning of hospital growth in the clinical workforce and numerous performance services. Unlike in England, targets have been set to improve population health, the quality and there is no competition outcomes of health care, and the efficiency of the health system. between trusts, and this has two implications. Firstly, funds to hospitals are distributed As a result, Scotland has made well-documented progress in geographically, based on a formula designed to ensure horizontal terms of population health and the quality and effectiveness of equity, with no market pressure on individual hospitals. Secondly, care. However, a number of challenges remain. More progress is control is bureaucratic, with the emphasis being on consultation needed to close the gap in health status between Scotland and and cooperation among health and social care bodies. Without other developed countries, and to address persistent inequalities competition, effective control over the system requires information in health, particularly in the most deprived areas where risk factors and transparency to ensure provider accountability, and a body such as smoking, alcohol consumption and poor diet are more outside the system to hold it to account. The restoration of the prevalent. As in many other countries, increased fiscal pressures locally elected Assembly in 2007 has created such a body, but it may make it difficult to maintain both the quantity and quality of is too early to judge how effectively it exercises accountability. health care service provision in future.

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New HiT for Wales Intersectoral Governance for Health in All Policies. Structures, actions and experiences By: M Longley, N Riley, P Davies and C Hernández-Quevedo

Copenhagen: World Health Organization 2012 (acting as the host Edited By: DV McQueen, M Wismar, V Lin, CM Jones organization for, and secretariat of, the European Observatory on and M Davies Health Systems and Policies). Copenhagen: WHO Regional Office for Europe on behalf of the Number of pages: 84 European Observatory on Health Systems and Policies. Observatory Studies Series No. 26, 2012 ISSN: 1817-6127 Vol. 14 No. 11 Number of pages: xix + 206 Available online at: http://www.euro.who.int/__data/assets/ pdf_file/0006/177135/E96723.pdf ISBN: 978 92 890 0281 3

Available online at: http://www.euro.who.int/en/who-we-are/ With approximately three million citizens, Wales contains about 5% partners/observatory/studies/intersectoral-governance-for-health- of the United Kingdom’s total population. For several decades, in-all-policies.-structures,-actions-and-experiences the country had a health system largely administered through the United Kingdom Government’s Welsh Office, but responsibility for Many of the policies and programmes that affect health originate most aspects of health policy was devolved to Wales in a process outside the health sector. Governments therefore need to address beginning in 1999. The overall budget Wales receives from the population health using a United Kingdom Government is based on its share of the total Cover_WHO_nr26_Mise en page 1 22/08/12 13:35 Page1 26 26 strategy or policy principle that

INTERSECTORALGOVERNANCE FOR HEALTH INALL POLICIES United Kingdom population and the National Assembly determines STRUCTURES, ACTIONS AND EXPERIENCES Intersectoral ct health originate outside the health sector. using a strategy or policy principle fosters intersectoral action.

Many of the policies and programmes that affe Observatory

Governments need, therefore, to address population health Governance for Series Studies how that ‘block grant’ is used. uraging intersectoral approaches to that fosters intersectoral action. lume captures the research on how inter sectoral Health in All Policies (HiAP) does just that, enco offers a framework for assessing: Health in all policies (HiAP) management, coordination and action. This vo Health in All Policies governance structures operate to help deliver HiAP.action, It and ccessfully established, used and sustained. • how governments and ministries can initiate Structures, actions and experiences • how intersectoral governance structures can bee su and relevant examples that can inform Since 1999, differences between the policy approach trumentsand available and equip them for does just that, encouraging This volume is intended to provide accessibl Edited by policy-makers of the governance tools and ins d Policies and the International Union for intersectoral action. David V. McQueen h more than 40 contributors to explore the The European Observatory on Health Systems an Matthias Wismar framework in England and Wales have widened. The internalral governance. This volume contains over intersectoral approaches to Health Promotion and Education have worked wit as, Asia and Australia on how countries currently Vivian Lin rationale, theory and evidence for intersecto different contexts. It also highlights nine key 20 mini case studies from Europe, the Americ Catherine M. Jones use intersectoral governance for HiAP in theirthey facilitate intersectoral action. They include: Maggie Davies Edited by David V. McQueen, Matthias market intersectoralintroduced structures and sets out how in the National management, coordination • cabinet committees and secretariats • parliamentary committees Health Service• interdepartmental committees (NHS) and units in England and action. This publication • mega-ministries and mergers Health Systems in Transition • joint budgeting Vol. 14 No. 11 2012 • delegated financing has been• public engagementabandoned in Wales, captures research on how • stakeholder engagement udy will also contribute to reducing the • industry engagement.

Wismar, Vivian Lin, Catherine M. Jones an It is hoped that in addition to being policy relevant this st and sevencurrent knowledge local gap in this field.health boards intersectoral governance

The editors ontrol and David V. McQueen, Consultant Global Health Promotion, IUHPE Immediate Past President & now plan formerly andAssociate Director provide for Global Health Promotion, all Centers health for Disease C structures operate, showing Prevention, Atlanta, United States of America. United Kingdom , Senior Health Policy Analyst, European Observatory on Health Systems and Matthias Wismar ciences, La Trobe University, Policies, Brussels, Belgium. (Wales) servicesVivian for Lin , Professor their of Public Health, resident Faculty of Health S Promotion and how governments and Melbourne, Australia. , Programme Director, International Union for Health Health system review Catherine M. Jones International, London, d Maggie Davies Education, Paris, France. populations., Executive Health Director, Health Actionservices Partnership in ministries can initiate action, Maggie Davies United Kingdom. Wales are financed almost and how intersectoral Observatory Studies Series No. 26 entirely out of general taxation governance structures can and are therefore, largely free be successfully established,

• Neil Riley Marcus Longley Cristina Hernández-Quevedo at point of use. There is used and sustained. Paul Davies • relatively limited private Contents: financing of health care, and Forewords; Acknowledgements; List of case studies; List of tables, the NHS makes very little use figures and boxes; Abbreviations; List of Contributors; Part I: Policy of the private sector. Issues and Research Results; 1) Introduction: Health in All Policies, The health system in Wales the social determinants of health and governance; 2) Synthesising continues to face some structural weaknesses that have the evidence: how governance structures can trigger governance proved resistant to reform for some time. However, there has been actions to support Health in All Policies; Part II: Analysing substantial improvement in service quality and outcomes since the Intersectoral Governance for HiAP; 3) Cabinet committees and end of the 1990s, in large part facilitated by substantial real growth cabinet secretariats; 4) The role of parliaments: the case of a in health care spending. However, with the change in the financial parliamentary scrutiny; 5) Interdepartmental units and committees; climate, Wales is now facing a severe reduction in expenditure, 6) Mergers and mega-ministries; 7) Joint budgeting: can it facilitate and there is some concern that the health system is not financially intersectoral action? 8) Delegated financing; 9) Involving the public sustainable in the longer term unless additional funds can be to facilitate or trigger governance actions contributing to HiAP; found to meet rising demand. Although life expectancy has 10) Collaborative governance: the example of health conferences; continued to increase, health inequalities have proved stubbornly 11) Industry engagement. resistant to improvement.

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NEWS

International addressed by the current action plan: together with the Member States promote increasing organ availability; enhancing the strategies for combating risk factors, such Conclusions of Employment, efficiency and accessibility of transplant as tobacco use, alcohol related harm, illicit Social Policy, Health and Consumer systems; and improving quality and safety. drugs, unhealthy diet and a lack of physical Affairs Council Measures to increase organ availability activity as well as environmental factors. were welcomed and the importance Access the Council conclusions at: http:// At a meeting of the Employment, Social of encouraging people to commit to www.consilium.europa.eu/uedocs/cms_ Policy, Health and Consumer Affairs becoming organ donors after death noted. Data/docs/pressdata/en/lsa/134090.pdf Council on 6 and 7 December in Brussels Mechanisms to increase the availability there was a discussion on progress made of organs could include transparent on a draft decision aimed at strengthening mechanisms for reimbursing living donors Tonio Borg appointed EU Commissioner EU capacities and structures for effectively for the costs incurred and, if applicable, for for Health and Consumer Affairs responding to serious cross-border health compensating the loss of income in direct threats and providing the incoming Irish relation to the living donation procedure. On 28 November the Deputy Prime presidency with guidance for further work. The conclusions also welcomed the Minister and Foreign Minister of Malta, establishment of bilateral and multilateral Serious cross-border health threats can be Tonio Borg, was approved as the agreements between Member States to events caused by communicable diseases, new EU Commissioner for Health and exchange organs. It was noted that there biological agents responsible for non- Consumer Affairs for the remainder of is a need to improve knowledge on health communicable diseases, as well as threats the Commission’s current term of office outcomes in transplanted patients across of chemical, environmental, or unknown (31 October 2014). EU ministers approved countries, including increased knowledge origin, including threats of malicious Tonio Borg’s nomination one week after on the transplantation of organs from intentional origin. Threats can also derive a majority of MEPs backed him in a vote “expanded criteria donors” such as older from the effects of climate change. The in the European Parliament. A statement donors in order to increase the number of objective of the draft decision will be to from the European Parliament also available organs. strengthen epidemiological surveillance in confirmed that he provided MEPs with the EU and the early warning and response The Council also adopted conclusions written assurances that he will respect the system; allow the joint procurement of on healthy ageing across the lifecycle. European Charter of Fundamental Rights, medical countermeasures (e.g. vaccines) They build on a conference organised as well as the rights of women and gay by several EU Member States; and give a by the presidency in September, and rights, issues which had been of concern to legal basis to the functioning of the health call for efforts to foster health promotion, some MEPs. In his European Parliamentary security committee. disease prevention and early diagnosis Hearing Mr Borg promised, without further to be stepped up. More specifically, the delay, to release an ambitious Tobacco During the Cyprus presidency it was noted conclusions acknowledge that innovative Products directive by January 2013, stating that good progress had been achieved approaches in health promotion and that the timetable had been “encouraged and the draft decision amended in line disease prevention could help older people and endorsed by Commission President with Member States’ comments. Changes to remain independent longer and improve Barroso”. Subsequently on 2nd December proposed by the Cyprus presidency notably their quality of life. They underline that the new Commissioner forwarded the draft ensure Member States’ autonomy in good health among working age people Directive to the Commissioner College preparedness and response planning, the contributes to higher productivity and for approval. non-mandatory character of preparedness other benefits for citizens and society to planning at European level and attributes to His appointment follows the resignation meet the goals of the EU2020 strategy for the Health Security Committee a key role of previous Commissioner John Dalli smart, sustainable and inclusive growth. in the consultations among the Member on 16 October. A statement released by The conclusions call upon Member States States and the Commission. However, the European Commission stated that to make the issue of healthy ageing further discussions are needed in order “Mr Dalli informed the President of the across the lifecycle one of their priorities to reach agreement in the Council on the European Commission Jose Manuel for the coming years and to adopt an whole proposal. This would enable the Barroso of his decision [to resign] following approach that shifts the focus towards incoming Irish presidency to engage in an investigation by OLAF, the EU’s health promotion, disease prevention and negotiations with the European Parliament antifraud office, into a complaint made early diagnosis. with a view to a first reading agreement. in May 2012 by the tobacco producer, The Commission was also invited to Swedish Match. The company alleged The Council also adopted conclusions contribute to the development of policies that a Maltese entrepreneur had used his on organ donation and transplantation, towards health promoting activities, and contacts with Mr Dalli to try to gain financial focusing on the three main challenges

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advantages from the company in return learnt from the case of an anti-diabetic drug by France and Germany (11.6%). The for seeking to influence a possible future suspected of having caused the deaths of share of GDP allocated to health was 9.0% legislative proposal on tobacco products, several hundreds of patients in France at a on average across EU countries, down in particular on the EU export ban on snus. time when it was already withdrawn from from 9.2% in 2009. As soon as the Commission received the the market in other Member States. In Ireland, health spending fell 7.9% in 2010, complaint it immediately requested OLAF An important aim for the Council was to compared with an average annual growth to investigate.” ensure that the new provisions lead to the rate of 6.5% between 2000 and 2009. In The statement added that “the OLAF early discovery of potentially dangerous Estonia, health expenditure per person final report was sent to the Commission medicinal products and do not lead to dropped by 7.3% in 2010, following growth on 15 October. It found that the Maltese adverse reactions not being noticed due of over 7% per year from 2000 to 2009, entrepreneur had approached the company to “information overflow”. An example of with reductions in both public and private using his contacts with Mr Dalli and sought the strengthened rules is that marketing spending. In Greece, estimates suggest to gain financial advantages in exchange for authorisation holders that withdraw a that health spending per person fell 6.7% influence over a possible future legislative medicine from the market will have to in 2010, reversing annual growth of 5.7% proposal on snus. No transaction was notify the competent authority and explain between 2000 and 2009. While the report concluded between the company and the reasons for their decision even if the does not show any worsening health the entrepreneur and no payment was withdrawal is voluntary. This also applies outcome due to the crisis, it also underlines made. The OLAF report did not find if the marketing authorisation holder that efficient health spending is necessary any conclusive evidence of the direct withdraws a medicine from a third country to ensure the fundamental goal of health participation of Mr Dalli but did consider market. This provision aims to avoid that systems in EU countries. that he was aware of these events. The the withdrawal of a medicine for safety Amongst other information in the report OLAF report showed clearly that the reasons goes unnoticed by or is hidden it is estimated that spending on disease European Commission’s decision making from competent authorities. prevention accounts for only 3% of total process and the position of the services In order to better inform patients and health spending, a reduction of 3.2% concerned has not been affected at all by medical professionals, additional groups of compared with the previous year. More the matters under investigation. The final pharmaceutical products will be included than half of adults in the European Union OLAF report and its recommendations on the publicly available list maintained are now overweight, and 17% are obese. are being sent by OLAF to the Attorney by the European Medicines Agency Obesity rates have doubled since 1990 in General of Malta. It will now be for the (EMA) of medicinal products, subject to many European countries, and now range Maltese judiciary to decide how to follow additional monitoring (for instance for from 8% in Romania and Switzerland up. After the President informed Mr Dalli safety reasons). The amendments to the to over 25% in Hungary and the United about the report received from OLAF, existing pharmaceutical legislation also Kingdom. Obesity and smoking are the Mr Dalli decided to resign in order to be contain a further strengthening of the major risk factors for heart disease and able to defend his reputation and that of rules concerning wholesale distribution of stroke which accounted for over one-third the Commission. Mr Dalli categorically medicinal products to third countries. (36%) of all deaths across EU countries rejects these findings.” in 2010. In terms of the workforce the The provisions of the directive have to be report notes that the number of doctors applied twelve months after the directive per capita has increased in almost all EU New actions against adverse effects enters into force. Member States over the past decade of medicines from an average 2.9 per 1 000 population in 2000 to 3.4 in 2010. Growth was On 4 October the Employment, Social Health spending in Europe in 2010 fell particularly rapid in Greece and the United Policy, Health and Consumer Affairs for the first time in decades, says a joint Kingdom. There are now many more Council of the European Union adopted Commission /OECD Report specialists than general practitioner in new rules aimed at strengthening the nearly all countries due to lack of interest post-authorisation monitoring of medicines Health spending per person and as a in traditional “family medicine” practice for human use (“pharmacovigilance”). This percentage of Gross Domestic Product fell and a growing remuneration gap. The slow followed a first-reading agreement with the across the European Union in 2010. This is growth or reduction in generalists raises European Parliament. The new legislation one of the many findings in the “Health at a concerns about access to primary care for focuses in particular on obligations on Glance: Europe 2012”, a new joint report by certain population groups. marketing authorisation holders in relation the OECD and the European Commission. to adverse reactions to medicinal products From an annual average growth rate The report is available at: http:// and further clarifying the procedures when of 4.6% between 2000 and 2009, health ec.europa.eu/health/reports/european/ competent authorities follow up such spending per person fell to -0.6% in 2010. and http://www.oecd.org/health/ reporting. It entails a further strengthening This is the first time that health spending healthataglanceeurope.htm of the pharmacovigilance rules adopted has fallen in Europe since 1975. Health by the Council on 29 November 2010 spending as a share of GDP was highest (17054/10) and responds to the lessons in the Netherlands (12%) in 2010, followed

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European Quality of Life Survey 2012 The report is available at: http://www. a series of options on how to implement published eurofound.europa.eu/publications/htmlfiles/ the judgment, taking into account the ef1264.htm constitutional, legal, medical and ethical The European Foundation for the considerations involved in the formulation Improvement of Living and Working of public policy in this area and the over- Conditions has published its third riding need for speedy action. quality of life survey, covering the 27 EU Country news The expert report, favours legislation, Member States. along with regulation, as the safest way to Ireland: government looks to clarify law The survey reports declines of over 20% in provide legal clarity. The Government will on abortion levels of optimism and happiness in some decide in December 2012 which option put countries across the EU and over a third forward by the expert group on abortion The Irish government published the Report of people indicated a deterioration in their to implement. of the Expert Group on the judgment in A, financial situation over the past five years. B and C v Ireland on November 27. This The publication of the report sadly These results largely reflect – with some report provides background information coincides with public debate in interesting exceptions – the economic on the termination of pregnancy in Ireland Ireland concerning the death of Savita reality, with highest optimism levels and sets out options for the implementation Halappanavar, who was 17 weeks reported in Denmark and Sweden and of the European Court of Human Rights pregnant when she died at University lowest levels in Greece, Italy, and Portugal. judgment in the A, B and C v Ireland case. Hospital Galway following a miscarriage. The social situation in the European She had asked for a medical termination Union today represents a complex and The Court accepted that Article 40.3.3 before she died on 28 October but was complicated story. Since the last survey of the Irish Constitution provides that it is reportedly refused. The Health Information in 2007, more people who had good lawful to terminate a pregnancy in Ireland and Quality Authority is to investigate the incomes and were in good quality housing if it is established as a matter of probability circumstances surrounding the care and are now struggling with unemployment, that there is a real and substantial risk to treatment provided to Mrs Halappanavar. debts, housing insecurity and access the life, as distinct from the health, of the to services. mother, which can only be avoided by a The report of the expert group is available termination of the pregnancy. While the at: http://www.dohc.ie/publications/ The survey also highlights that it is harder Court dismissed the applications of Ms A Judgement_ABC.html for many people to make ends meet: 7% and Ms B, for Ms C the Court found that report ‘great difficulty’ making ends meet, Ireland had failed to respect the applicant’s with large differences between Member private life contrary to Article 8 of the Russia: Parliament takes first step States, ranging from 22% in Greece to 1% Convention, as there was no accessible towards ban on smoking in public places in Finland. When asked to whom they and effective procedure to enable her to would turn to urgently borrow money, most establish whether she qualified for a lawful On 14 December, the Russian Parliament Europeans (70%) would ask a member termination of pregnancy in accordance (Duma) voted overwhelmingly to approve of their family or a relative for a loan. with Irish law. Ms C had been treated for the first reading of a bill to ban smoking Another 12% would ask a friend, neighbour cancer for three years. When she became in public spaces and to restrict tobacco or someone else, while 8% would turn unintentionally pregnant she was in sales. Under the draft legislation tobacco to a service provider or institution. One remission, and being unaware of this fact, advertising will be outlawed and smoking in out of ten report they would not be able went for a series of follow-up tests related public places such as restaurants, bars and to ask anybody; this was particularly true to her illness which were contraindicated hotels will be phased out. It will also ban among people in the lowest income quartile during early pregnancy. She was unable to kiosks and outlets in stations from selling (15%). Overall, 8% of people in the EU have obtain clear medical advice as to the effect cigarettes. been unable to pay back informal loans of the pregnancy on her health/life or as to according to schedule. The second reading of the bill is expected the effect of the medical treatment on the in spring 2013. If passed, the restrictions The overview report examines a range foetus, and feared the possibility that the will be fully implemented by 2016. The new of issues such as employment, income, pregnancy might lead to a recurrence of the move follows plans for an increase in excise housing and living conditions, family, cancer. She decided to have an abortion duty on tobacco by 40% in 2013 and 2014 health, work-life balance, life satisfaction and travelled to the UK for the procedure. and 10% per annum thereafter. and perceived quality of society. Further The Court ruled that “no criteria or reports on subjective well-being, social procedures have been... laid down in Irish inequalities, quality of society and public law … by which that risk is to be measured Additional materials supplied by: services, and trends in quality of life over or determined, leading to uncertainty …” EuroHealthNet the three survey waves will follow in 2013. and held that further legal clarity was 6 Philippe Le Bon, Brussels. It is also expected that the dataset will be required. In response to the judgement the Tel: + 32 2 235 03 20 made available to the public through the Government established an expert group to Fax: + 32 2 235 03 39 UK Data Archive in spring 2013. make recommendations on how this matter Email: [email protected] should be addressed and recommend

Eurohealth incorporating Euro Observer — Vol.18 | No.4 | 2012 flyer_milano2013_PRINT.pdf 6/6/12 8:01:09 AM

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