Eurohealth RESEARCH•DEBATE•POLICY•NEWS Volume 14 Number 1, 2008
Health system snapshots: perspectives from six countries
Prospects for a new golden era in vaccines?
Access to research data
Supporting and using publicly orientated health research
Irish private health insurance market • Pharmaceutical policy in Central and Eastern Europe Diabetes risk • Lives saved vs life years saved • Pharmaceutical sector governance Knowledge: our most precious Eurohealth commodity LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom C We hear a lot about the soaring price of commodities fax: +44 (0)20 7955 6090 www.lse.ac.uk/LSEHealth such as oil and gas. The global energy crisis will not be resolved through further exploration for fossil fuels. Editorial Team Instead, that most precious of commodities, EDITOR: knowledge, can help find innovative ways of David McDaid: +44 (0)20 7955 6381 email: [email protected] harnessing new sources of energy. O FOUNDING EDITOR: Elias Mossialos: +44 (0)20 7955 7564 Knowledge is also priceless for health policy. email: [email protected] Intelligence on the state of health systems is vital, yet DEPUTY EDITORS: it can be difficult to keep up with the rapid pace of Sherry Merkur: +44 (0)20 7955 6194 email: [email protected] change. In this issue of Eurohealth we include Philipa Mladovsky: +44 (0)20 7955 7298 M email: [email protected] snapshots on six countries. Originally commissioned and funded by the New York based Commonwealth EDITORIAL BOARD: Reinhard Busse, Josep Figueras, Walter Holland, Fund, and prepared in a common format, they provide Julian Le Grand, Martin McKee, Elias Mossialos
an opportunity to reflect on approaches to efficiency SENIOR EDITORIAL ADVISER: and quality improvement. Paul Belcher: +44 (0)7970 098 940 M email: [email protected] We are also delighted to include a contribution from DESIGN EDITOR: Sarah Moncrieff: +44 (0)20 7834 3444 historian Louis Galambos, who highlights challenges email: [email protected]
for the global vaccine industry and how these parallel SUBSCRIPTIONS MANAGER past events. In an economic downturn, cost pressures Champa Heidbrink: +44 (0)20 7955 6840 may first be felt in areas viewed as low priorities. All email: [email protected] E too often public health research can suffer. As well as Advisory Board the potential lost health benefits, the economic Anders Anell; Rita Baeten; Nick Boyd; Johan Calltorp; consequences of reduced investment into vaccine Antonio Correia de Campos; Mia Defever; Nick Fahy; Giovanni Fattore; Armin Fidler; Unto Häkkinen; Maria research and development may be substantial: Europe Höfmarcher; David Hunter; Egon Jonsson; Meri Koivusalo; currently produces around 90% of the world’s Allan Krasnik; John Lavis; Kevin McCarthy; Nata Menabde; Bernard Merkel; Stipe Oreskovic; Josef Probst; N vaccines. Professor Galambos argues that we should Tessa Richards; Richard Saltman; Igor Sheiman; Aris focus on the long-term benefits of vaccines to society, Sissouras; Hans Stein; Jeffrey L Sturchio; Ken Thorpe; Miriam Wiley rather than just being mindful of short-term budgetary requirements. Article Submission Guidelines see: www.lse.ac.uk/collections/LSEHealth/documents/ We also feature two articles looking at how knowledge eurohealth.htm can better inform policy making. Hans Stein looks at Published by LSE Health and the European Observatory T on Health Systems and Policies, with the financial support the role of international organisations in public health of Merck & Co and the European Observatory on Health research across the EU. He calls for more emphasis on Systems and Policies. ensuring that research is feasible, policy relevant and Eurohealth is a quarterly publication that provides a forum for researchers, experts and policymakers to express their linked to the policy making process. Philipa views on health policy issues and so contribute to a Mladovsky and colleagues, meantime, argue that we constructive debate on health policy in Europe. are losing an opportunity to make use of much The views expressed in Eurohealth are those of the authors alone and not necessarily those of LSE Health, Merck & Co existing knowledge. The European Commission, they or the European Observatory on Health Systems and contend, should adopt measures to promote much Policies. more open access to data collected within Research The European Observatory on Health Systems and Policies is a partnership between the World Health Organization Framework projects. Again, secondary analyses of Regional Office for Europe, the Governments of Belgium, such data could prove invaluable in generating new Finland, Greece, Norway, Slovenia, Spain and Sweden, the Veneto Region of Italy, the European Investment Bank, the knowledge that might be used in countering the global Open Society Institute, the World Bank, the London School health crisis. of Economics and Political Science, and the London School of Hygiene & Tropical Medicine.
David McDaid Editor © LSE Health 2008. No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted Sherry Merkur Deputy Editor in any form without prior permission from LSE Health.
Philipa Mladovsky Deputy Editor Design and Production: Westminster European email: [email protected]
Printing: Optichrome Ltd
ISSN 1356-1030 Contents Eurohealth Volume 14 Number 1
European Snapshots Anders Anell is Professor, Institute of Economic Research, School of Economics 1 The health system in England and Management, Lund University, Sweden. Seán Boyle Seán Boyle is Senior Research Fellow, LSE 3 The health system in France Health, London School of Economics and Isabelle Durand-Zaleski Political Science, UK. 5 The health system in Germany Reinhard Busse is Professor of Health Care Reinhard Busse Management, Technical University Berlin, Germany. 7 The health system in Denmark Karsten Vrangbæk Isabelle Durand-Zaleski is Professor of Medicine, University de Paris XII, France.
8 The health system in the Netherlands Armin Fidler is Health Sector Manager, Niek Klazinga Europe and Central Asia Region, The World Bank, Washington DC, USA. 10 The health system in Sweden Anders Anell Louis Galambos is Professor of History, Department of History and the Institute for Applied Economics and the Study of Public Health Perspectives Business Enterprise, Johns Hopkins University, USA. 12 What are the prospects for a new golden era in vaccines? Louis Galambos Niek Klazinga is Professor of Social Medicine, Academic Medical Centre, 15 Access to research data in Europe University of Amsterdam, the Netherlands. Philipa Mladovsky, Elias Mossialos and Martin McKee Martin McKee is Professor of European 18 Supporting and using policy-oriented public health research at Public Health, London School of Hygiene & the European level Tropical Medicine, UK. Hans Stein Philipa Mladovsky is Research Officer, LSE Health and European Observatory on Health Systems and Policies, London School Health Policy Developments of Economics and Political Science, UK 23 Celtic Tiger, Health Care Dragon: Fiery debates in the Irish Elias Mossialos is Director and Professor of private health insurance market Health Policy, LSE Health and European Brian Turner Observatory on Health Systems and Policies, London School of Economics and 25 Governance in the pharmaceutical sector Political Science, UK. Armin Fidler and Wezi Msisha Wezi Msisha is Health Specialist, Europe 30 Pharmaceutical policy challenges in Central and Eastern Europe and Central Asia Region, The World Bank, Andreas Seiter Washington DC, USA.
Andreas Seiter is Senior Health Specialist, Evidence-informed Decision Making The World Bank, Washington DC, USA. 33 “Bandolier” Moderate activity reduces diabetes risk Hans Stein is based at the European Public Health Centre North Rhine-Westfalia, 34 “Risk in Perspective” Valuing "lives saved" vs. "life-years saved" Germany. Brian Turner was formerly Head of Research/Technical Services at the Health Monitor Insurance Authority and is currently a part- time lecturer and full-time PhD student at the 38 Publications Department of Economics, University College Cork, Ireland. 39 Web Watch Karsten Vrangbæk is Associate Professor, 40 News from around Europe Department of Political Science, University of Copenhagen, Denmark. EUROPEAN SNAPSHOTS The health system in England
Seán Boyle
Who is covered? amount of prescription drugs. Transport different local contracting possibilities, as Coverage is universal. All those ‘ordinarily costs to and from provider sites are also well as providing substantial financial resident’ anywhere in the United covered for people on low incomes. incentives tied to achievement of clinical Kingdom* are entitled to health care that is and other performance targets. Private largely free at the point of use. How are revenues generated? providers of GP services set their own fee- National Health Service (NHS): the NHS for-service rates but are not generally reim- What is covered? accounts for 86% of total health expen- bursed by the public system. Services: the publicly-funded National diture. It is mainly funded by general Hospitals: these are organised as NHS Health Service (NHS) covers preventative taxation (76%), but also by national trusts directly responsible to the services; inpatient and outpatient (ambu- insurance contributions (19%) and user Department of Health. More recently, latory) hospital (specialist) care; physician charges (5%).3 Apart from the income the foundation trusts have been established as (general practitioner) services; inpatient NHS receives for the provision of semi-autonomous, self-governing public and outpatient drugs; dental care; mental prescription drugs and dentistry services trusts. Both contract with PCTs for the health care; learning disabilities and reha- to the general population, there is some provision of services to local populations. bilitation. income from other fees and charges, Public funds have always been used to particularly to private patients who use Cost sharing: there are relatively few cost purchase some care from the private sector, NHS services. sharing arrangements for publicly-covered but since 2003 some routine elective services. Drugs prescribed by general prac- Private health insurance: a mix of for- surgery has been procured for NHS titioners are subject to a co-payment (£7.10 profit and not-for-profit insurers provide patients from purpose-built treatment (€8.85) per prescription), but about 88% of supplementary private health insurance. centres owned and staffed by private sector prescriptions are exempt from charges.1 Private insurance offers choice of providers. Consultants (specialists) work Dentistry services are subject to co- specialists, avoidance of queues for elective mainly in NHS hospitals but may payments of up to about £200 (€250) per surgery and higher standards of comfort supplement their salary by treating private year; in some areas there is difficulty in and privacy than the NHS. United patients. obtaining NHS dental services. Out-of- Kingdom-wide it covered 12% of the Government: responsibility for health pocket payments accounted for 11.9% of population and accounted for 1% of total legislation and general policy matters rests total expenditure on health in the UK in health expenditure in 2005. with Parliament at Westminster. The NHS 2005.2 Other: individuals also pay directly out of is administered by the NHS Executive and Safety nets: most costs are met from the pocket for some services – for example, the Department of Health, and locally is public purse. There are measures in place care in the private sector. Direct out-of- provided through a series of contracts to alleviate costs where these may have an pocket payments account for over 90% of between commissioners of health care undue impact on certain patient groups. total private expenditure on health. services (PCTs) and providers (hospital The following are exempt from trusts, GPs, independent providers). PCTs prescription drug co-payments: children How is the delivery system organised? control around 85% of the NHS budget under the age of sixteen years and those in Physicians: general practitioners (GPs) are (allocated to them based on a risk-adjusted full-time education up to age eighteen; usually the first point of contact for capitation formula) and are responsible for people aged sixty years or over; people on patients and act as gatekeepers for access ensuring the provision of primary and low incomes; pregnant women and those to secondary care services. Most GPs are community services for their local popula- having had a baby in the last twelve paid directly by primary care trusts (PCTs) tions. Recent policy developments include months; and people with certain medical through a combination of methods: salary, the introduction of patient choice of conditions and disabilities. There are capitation and fee-for-service. The 2004 hospital and a move to the reimbursement discounts through pre-payment certifi- GP contract introduced a range of of hospitals using a Diagnosis Related cates for those individuals who use a large
* Although coverage is applicable across the whole of the United Kingdom, the structure Seán Boyle is Senior Research Fellow, LSE of health systems in Northern Ireland, Scotland and Wales are a matter for local devolved Health and Social Care, London School of administrations and differ significantly from the system in England. The situation in these Economics and Political Science, London, countries is not discussed in this paper. However it should though be noted that data on UK. expenditure obtained from the World Health Organization refer to the entire United Email: [email protected] Kingdom.
1 Eurohealth Vol 14 No 1 EUROPEAN SNAPSHOTS
Group (DRG) like activity-based funding the practice is organised, how patients ways of providing health care through the system known as Payment by Results view their experience at the surgery, use of semi-autonomous bodies such as the (PbR). PbR relates payment to the quantity whether extra services are offered, such as Institute for Innovation and Improvement. and casemix of activity undertaken. child health and maternity, and how well The Institute helps the NHS to develop common chronic diseases such as asthma new ways of dealing with the introduction Private insurance funds: private insurers and diabetes are managed. of new technology and changes to working provide their subscribers with health care practices, and helps to spread these at a range of private and NHS hospitals. What is being done to improve throughout the NHS. Patients generally can choose from a efficiency? number of health care providers. Efficiency has always been a key focus of How are costs controlled? the NHS. The NHS seeks to improve effi- The government sets the budget for the What is being done to ensure quality of ciency in a range of ways including: NHS on a three-year cycle. To control care? utilisation and costs, the government sets Quality of care is a key focus of the NHS. High-level efficiency targets: the a capped overall budget for PCTs. NHS A Department of Health objective in 2007 government is committed to a programme trusts and PCTs are expected to achieve was to enhance the quality and safety of to achieve efficiency gains of £6.5 (€8.1) financial balance each year. The centralised health and social care services. Quality billion by March 2008 through a range of administrative system tends to result in issues are addressed in a range of ways policies known as the Gershon Efficiency lower overhead costs. Other mechanisms outlined below. Programme. These include increasing that contribute to improved value for front-line productivity, centralising Regulatory bodies: a number of bodies money include arrangements for the procurement to obtain more cost-effective monitor and assess the quality of health systematic appraisal of both new and deals, reductions in the costs of both NHS services provided by public and private existing technologies through the National provider and central administration and providers. This involves regular assessment Institute for Health and Clinical Excel- increasing the efficiency of social care of all providers, investigation of individual lence (NICE). provision. Local NHS organisations are providers where an issue has been drawn also set targets for efficiency savings. to the attention of a regulatory body and consideration of key areas of provision in Benchmarking: NHS organisations are REFERENCES order to recommend best practice. The benchmarked against the performance of 1. Department of Health. Departmental three bodies primarily responsible for their peers on a number of activity Report 2007. London: Department of regulation in England (the Healthcare measures including day case rates and Health, 2007. Commission, the Commission for Social lengths of stay for common operative 2 World Health Organization. World Care Inspection and the Mental Health procedures, readmission rates and NHS Health Statistics 2007. Geneva: World Act Commission) are due to be merged reference costs (costs of standard proce- Health Organization, 2007. later in 2008. dures known as Healthcare Resource Groups). The Healthcare Commission 3. Department of Health. Departmental Targets: targets have been set by the Report 2006. London: Department of reviews the performance of NHS trusts government for a range of variables that Health, 2006. against these measures in providing an reflect the quality of care delivered. Some overall assessment of NHS performance of these targets are monitored by the regu- through the Annual NHS Health Check. latory bodies mentioned above; others are ACKNOWLEDGEMENT: This article was monitored on a regular basis either by the Institute for Innovation and Improvement: originally commissioned and funded by the Commonwealth Fund, New York, Department of Health or its regional the Department of Health supports the USA organisations (ten strategic health author- development of better and more efficient ities). National Service Frameworks (NSFs): since WHO European Ministerial Conference 1998 the Department of Health has developed a set of NSFs intended to “Health Systems, Health and Wealth” improve particular areas of care (for example, coronary disease, cancer, mental Tallinn, Estonia, 25–27 June 2008 health, diabetes). These set national stan- Organized by WHO/Europe and hosted by the Government of dards and identify key interventions for the Republic of Estonia, the Conference aims to place health defined services or care groups. They are systems high on the political agenda. Specifically it will: one of a range of measures used to raise quality and decrease variations in service. • lead to better understanding of the impact of health systems on people's health and therefore on economic Quality and Outcome Framework: this is a growth in the WHO European Region; new framework for measuring the quality of care delivered by GPs. It was intro- • take stock of recent evidence on effective strategies to duced as part of the new GP contract in improve the performance of health systems, given the 2004, which provided incentives for increasing pressure on them to ensure sustainability and solidarity. improving quality, and has been operating since 2005. GP practices are awarded www.euro.who.int/healthsystems2008 points related to payments for how well
Eurohealth Vol 14 No 1 2 EUROPEAN SNAPSHOTS The health system in France
Isabelle Durand-Zaleski
Who is covered? between the two rates cannot be reim- health expenditure respectively.1 Coverage is universal. All residents are bursed by complementary private entitled to publicly financed health care. health insurance (see below). How are revenues generated? Following the introduction of Couverture In addition to cost sharing through co- Publicly financed health care: the public Maladie Universelle (CMU) in 2000, the insurance, which can be fully reimbursed health insurance scheme is financed by state finances coverage for residents not by complementary private health employer and employee payroll taxes eligible for coverage by the public health insurance, the following non-reimbursable (43%); a national income tax (contribution insurance scheme (0.4% of the popu- co-payments apply from 2008, up to an sociale generalisée; 33%) created in 1990 to lation). The state also finances health annual ceiling of €50: €1 per doctor visit, broaden the revenue base for social services for illegal residents (L’Aide €0.50 per prescription drug, €2 per ambu- security; revenue from taxes levied on Médicale d’Etat; AME). lance journey and €18 for expensive treat- tobacco and alcohol (8%); state subsidies ments. (2%); and transfers from other branches of What is covered? social security (8%). CMU is mainly Reimbursement by the publicly financed Services: the public health insurance financed by the state through an health insurance scheme is based on a scheme covers hospital care, ambulatory earmarked tax on tobacco and a 2.5% tax reference price. Doctors and dentists may care and prescription drugs. It provides on the revenue of complementary private charge above this reference price (extra minimal cover for outpatient eye and health insurers. There is no ceiling on billing) based on their level of professional dental care. employer (12.8%) and employee (0.75%) experience. The difference between the contributions, which are collected by a Cost sharing: cost sharing is widely applied reference price and the extra billed amount national social security agency. Public to publicly financed health services and must be paid by the patient and may or expenditure accounted for 79.1% of total drugs and takes three forms. may not be covered by complementary expenditure on health in 2005.1 private health insurance. Co-insurance rates are applied to all health Government: the public health insurance services and drugs listed in the publicly Safety nets: exemptions from co-insurance funds are managed by a board of represen- financed benefits package. Rates vary apply to people receiving disability and tatives, with equal representation from depending on: work injury benefits, people with specific employers and employees (trades unions). chronic illnesses and those on low – the type of care: hospital care (20% plus Every year parliament sets a (soft) ceiling incomes. Hospital co-insurance only a daily co-payment of €16), doctor for the rate of expenditure growth in the applies to the first thirty-one days in visits (30%), dental care (30%); public health insurance scheme for the hospital and some surgical interventions following year (Objectif National de – the type of patient: patients with are exempt. Children and people on low Dépenses d’Assurance Maladie, ONDAM). chronic conditions and poorer patients incomes are exempt from making non- In 2004, a new law created two new associ- are exempt from cost sharing; reimbursable co-payments. ations, the National Union of Health – the effectiveness of prescription drugs: Complementary private health insurance Insurance Funds (Union Nationale des 0% for highly effective drugs, 35%, covers statutory cost sharing (the share of Caisses d’Assurance Maladie, UNCAM) 65% and 100% for drugs of limited health care costs not reimbursed by the and the National Union of voluntary therapeutic value; and health insurance scheme). It only applies to health insurers (Union Nationale des health services and prescription drugs listed Organismes Complémentaires d’Assurance – whether or not patients comply with in the publicly financed benefits package. Maladie, UNOCAM), incorporating all the recently-implemented gatekeeping Most people obtain complementary private public health insurance funds and private system (médecin referent). Visits to the cover through their employment. Since health insurers respectively. The law also gatekeeping general practitioner (GP) 2000, individuals on low incomes are gave the public health insurance funds are subject to a 30% co-insurance rate, entitled to free complementary private responsibility for defining the benefits while visits to other GPs are subject to cover (CMU-C) and free eye and dental package and setting price and cost sharing a 50% co-insurance rate; the difference care; in addition, they cannot be extra levels. billed by doctors. Complementary private Private health insurance: complementary health insurance now covers over 92% of Isabelle Durand-Zaleski is Professor of private health insurance reimburses Medicine, University de Paris XII, Paris, the population. In 2005, out-of-pocket statutory cost sharing. It is mainly France. Email: payments and private health insurance provided by not-for-profit employment- [email protected] accounted for 7.4% and 12.8% of total
3 Eurohealth Vol 14 No 1 EUROPEAN SNAPSHOTS based mutual associations (mutuelles), hospitals. The remainder are in private for- 2008. which cover 87% to 90% of the popu- profit clinics. All university hospitals are Procedural changes on the supply side lation. It only covers those services that are public. Hospital physicians in public or mainly focus on two issues: the reorgani- already covered by the public health not-for-profit facilities are salaried. Since sation of inputs (for example, by trans- insurance scheme. There is some evidence 1968, hospital physicians have been ferring some physician tasks to nurses or to show that the quality of coverage permitted to see private patients in public other professionals) and improved co- purchased (in other words, the extent of hospitals, an anachronism originally ordination of care (particularly for patients reimbursement) varies by income group. intended to attract the most prestigious with chronic illnesses). On the demand Since 2000, people on low incomes doctors to public hospitals and one that side, the main health insurance scheme is (including the unemployed and those has survived countless attempts to abolish experimenting with patient education and receiving single parent subsidies) and their it. From 2008, all hospitals and clinics will hotlines. As of 2008 it will also transfer dependants have been entitled to obtain be reimbursed via a DRG (Diagnosis some drugs to over-the- counter status. complementary private cover at no or very Related Group)-like prospective payment low cost (CMU-C). CMU-C covers about system (the original DRG scheme was How are costs controlled? two million people via a voucher which only to be fully implemented by 2012). Cost control is a key issue in the French can be used to obtain cover from a variety Public and not-for-profit hospitals benefit health system as the health insurance of insurers, although most choose to from additional non activity-based grants scheme has faced large deficits for the last obtain cover from the public health to compensate them for research and twenty years. More recently the deficit has insurance scheme. More recently, for- teaching (up to an additional 13% of the fallen, from €10-12 billion per year in 2003 profit commercial insurers have started to budget) and for providing emergency to an expected €6 billion in 2007. This may offer cover for services not included in the services and organ harvesting and trans- be attributed to the following changes, public benefits package. For example, the plantation (on average an additional 10- which have taken place in the last two company AXA offered a plan offering 11% of a hospital’s budget). years: faster access to renowned specialists, but this was outlawed by the physicians’ asso- What is being done to ensure quality of – a reduction in the number of acute ciation and parliament. care? hospital beds; An accreditation system is used to monitor – limits on the number of drugs reim- How is the delivery system organised? the quality of care in hospitals and clinics. bursed; around six hundred drugs have The quality of ambulatory care rests on a Health insurance funds: public health been removed from public reim- system of professional practice appraisal. insurance funds are statutory entities and bursement in the last few years; Both systems are mandatory, under the membership is based on occupation so responsibility of the national health – an increase in generic prescribing and there is no competition between them. authority (Haute Authorité de Santé, the use of over-the-counter drugs; There is limited competition among HAS) created in 2004. Hospitals must be mutual associations providing comple- – the introduction of a voluntary gate- accredited every four years by a team of mentary private health insurance, but as keeping system in primary care; experts. The accreditation criteria and they are employment-based, most reports are publicly available via the HAS – protocols for the management of employees usually only have a choice of website (www.has-sante.fr). Every fifth chronic conditions; and one or two mutuelles. There is no system year physicians are required by law to of risk adjustment among mutuelles, even – from 2008, new co-payments for undergo an external assessment of their though there is inadvertent risk selection prescription drugs, doctor visits and practice in the form of an audit. For based on occupation. ambulance transport are not reim- hospital physicians, the practice audit can bursable by complementary private Physicians (non-hospital based physicians): be performed as part of the accreditation health insurance the 2004 health financing reform law intro- process. For physicians in ambulatory duced a voluntary gatekeeping system for practice, the audit is organised by an inde- At the same time, there has been an adults (aged 16 years and over) known as pendent body approved by HAS (usually a increase in the number of medical students médecin traitant. There are strong financial medical society representing a particular admitted to university due to an expected incentives to encourage gatekeeping. specialty). Dentists and midwives will shortage of doctors in the coming decade. Physicians are self-employed and paid on a soon have to undergo a similar process. Public funding has also had to increase to fee for service basis. The cost per visit is accommodate a rise in the fee schedule, slightly higher for specialists (€23) than for What is being done to improve since GPs are now considered as specialists GPs (€22) and is based on negotiation efficiency? and their cost per visit has risen from €20 between the government, the public Improving efficiency is the major challenge to €22. insurance scheme and the medical unions. facing the public health insurance funds, Depending on the total duration of their which are currently working on structural medical studies, physicians may charge and procedural changes. Structural changes REFERENCES above this level. There is no limit to what involve the creation of a national comput- 1. World Health Organization. World physicians may charge, but medical asso- erised system of medical records to limit Health Statistics 2007. Geneva, World ciations recommend tact in determining duplication of tests, over prescribing and Health Organization, 2007. Available at: fee levels. adverse drug side effects, and to facilitate http://www.who.int/whosis/whostat2007/ en/index.html Hospitals: two-thirds of hospital beds are the implementation of prospective in government-owned or not-for-profit payment for all hospitals and clinics from
Eurohealth Vol 14 No 1 4 EUROPEAN SNAPSHOTS The health system in Germany
Reinhard Busse
Who is covered? co-payments were introduced for adult However, from 2009, a uniform contri- Publicly-financed (‘social’) health insur- visits to physicians and dentists (€10 each bution rate will be set by the government ance is compulsory for employees earning for the first visit per quarter or subsequent and, although SFs will continue to collect up to €48,000 per year and their depen- visits without referral), while other co- contributions, all contributions will be dants. Employees with earnings above this payments were made more uniform: €5 to centrally pooled by a new national fund, amount are currently not obliged to be €10 per pack of outpatient prescription which will allocate resources to each SF covered. If they wish, they can remain in drugs (except if the price is at least 30% based on an improved risk-adjusted capi- the publicly-financed scheme on a below the reference price , which is the tation formula. In addition to this, SFs will voluntary basis, they can purchase private case for more than 12,000* drugs), €10 per be allowed to charge their members a flat- health insurance or they can be uninsured. inpatient day (up to twenty-eight days per rate premium. In 2005 public sources of The publicly-financed scheme covers year) and €5 to €10 for prescribed medical finance accounted for 77.2% of total health 1 about 88% of the population. Around aids. For dental prostheses, patients receive expenditure. three quarters of those who are able to a lump sum which covers, on average, 50% Private health insurance: private health choose between public or private health of costs. In total, out-of-pocket payments insurance playing a substitutive role** insurance (less than 20% of the popu- accounted for 13.8% of total health expen- covers groups excluded from publicly- 1 lation) opt to remain in the publicly- diture in 2005. financed health insurance (civil servants financed scheme, which offers free cover Safety nets: children up to the age of and self-employed people; the former have of dependants. Most of the remainder eighteen are exempt from cost sharing. part of their health care costs directly reim- purchase private health insurance. In total, Cost sharing is generally limited to an bursed by their employers) and high 10% of the population are covered by annual maximum of 2% of household earners who choose to opt out of the private health insurance, mainly civil income (or 1% for chronically ill people). publicly-financed scheme. All pay a risk- servants and self-employed people who For additional family members, a rated premium, although contracts are generally do not fall under social health proportion of household income is based on life-time underwriting, so risk is insurance. Less than 1% of the population excluded from this calculation. assessed upon entry only. Substitutive has no insurance coverage at all. From private health insurance is regulated by the 2009, health insurance will be compulsory How are revenues generated? government to ensure that the insured do for the whole population, depending on not face increasing premiums as they age previous insurance and/or job status. The publicly-financed scheme: this is (the old age reserves requirement) and that operated by over two hundred competing they are not overburdened by premiums if What is covered? health insurance funds (known as sickness their income falls (access to a ‘standard funds - SFs): autonomous, non-profit, tariff’ with benefits and premiums that Services: the publicly-financed benefits non-governmental bodies regulated by the match those of the publicly-financed package covers preventive services; inpa- government. The scheme is funded by scheme). From 2009, private insurers tient and outpatient hospital care; compulsory contributions on the first offering substitutive cover will be required physician services; mental health care; €43,000 earned in a year. On average, the to take part in a risk adjustment scheme to dental care; prescription drugs; rehabili- employee contributes almost 8% of gross finance the costs of cover for people in ill tation; and sick leave compensation. Long- earnings, while the employer contributes a health, who would otherwise not be able term care is covered by a separate further 7%. Dependants are covered to afford a risk-rated premium. Private insurance scheme, which has been through the primary SF member. Unem- health insurance also plays a mixed compulsory for the whole population ployed people contribute in proportion to complementary and supplementary role, since 1995. their unemployment entitlements, but providing SF members with cover for since 2004 the government employment Cost sharing: traditionally the publicly- some health care costs and access to better agency has paid a flat rate per capita contri- financed scheme has imposed few cost amenities. In 2005, private health insurance bution for long-term unemployed people. sharing provisions (mainly for pharmaceu- accounted for 9.1% of total health expen- ticals and dental care). However, in 2004 Currently, SFs are free to set their own contribution rates for all other members. diture.
Reinhard Busse is Professor of Health Care Management, Technical University * The reference price is the maximum price reimbursed for a group of equal or similar drugs. Berlin, Berlin, Germany. ** Substitutive private health insurance covers people excluded from or allowed to opt out Email: [email protected] of the publicly-financed health insurance scheme.
5 Eurohealth Vol 14 No 1 EUROPEAN SNAPSHOTS
How is the delivery system organised? Government: the German government address efficiency more directly. Since delegates regulation to the self-governing 2004, all drugs (patented as well as generic) Physicians: individuals have free choice of corporatist bodies of the sickness funds have been subject to reference prices unless ambulatory physician. General practi- and the providers’ associations. The most they can clearly demonstrate added value. tioners have no formal gatekeeper important body is the Federal Joint Beginning in 2008, IQWiG will explicitly function. However, in 2004 SFs were Committee (G-BA) created in 2004 to evaluate the cost-effectiveness of drugs, required to offer their members the option increase efficacy and compliance. Greater putting pressure on pharmaceutical prices. of enrolling in a ‘family physician care purchasing power has also been given to The DRG system for paying hospitals is model’ which may provide a bonus for individual SFs, for example, to contract based on average costs. complying with gatekeeping rules. Ambu- providers directly, to negotiate rebates latory specialist care is mainly delivered by with pharmaceutical companies or to How are costs controlled? private for-profit providers working in procure medical aids. In line with a greater emphasis on quality single practice, although policlinic-type and efficiency, the cruder cost containment ambulatory care centres with employed What is being done to ensure quality of measures used in the past have been physicians have been permitted since 2004. care? revised (notably, the use of sector-wide Physicians in the ambulatory sector are A range of measures have been introduced budgets for ambulatory physicians, paid a mixture of fees per time period and to ensure quality of care. Structural quality hospital budgets and the collective regional per medical procedure. These are agreed is addressed by the requirement for all drug prescription cap for physicians). The following annual negotiations between SFs providers to establish a quality drug prescription cap, which comple- and regional physician associations to management system; the obligation for mented reference pricing for pharmaceu- determine aggregate payments. continuous medical education for all ticals, was lifted in 2001, initially leading to Hospitals: individuals have free choice of physicians; health technology assessment an unprecedented increase in spending on hospital (following referral). Hospitals are for drugs and procedures, for which the pharmaceuticals by SFs. Following this, mainly non-profit, both public (about half Institute for Quality and Efficiency drug prescription caps with individual of beds) and private (about a third of beds). (IQWiG) was founded in 2004; voluntary physician liabilities were introduced. More The private, for-profit hospital sector has hospital accreditation; and minimum recently, contracts involving rebates and grown in recent years (about a sixth of volume requirements for a number of incentives to lower prices below the beds), mainly through takeovers of public complex inpatient procedures (such as reference price are being used to control hospitals. Independent of ownership, transplants). Process and (in part) outcome pharmaceutical spending. In 2009 hospital hospitals are principally staffed by salaried quality is addressed through the budgets will be fully replaced by the DRG doctors. Senior doctors may also treat mandatory quality reporting system for all system (using state-wide base rates). From privately-insured patients on a fee-for- acute hospitals. Under this system, over 2009, budgets for ambulatory care will be service basis. Doctors in hospitals are typi- one hundred and fifty indicators are replaced by a more sophisticated resource cally not allowed to treat outpatients, measured for thirty medical conditions allocation mechanism that accounts for although exceptions have been made when covering about a sixth of all inpatients. population morbidity. necessary care cannot be provided on an Hospitals receive individual feedback. outpatient basis by specialists in private Since 2007, around thirty indicators are practice. Since 2004, hospitals may also required to be made public in the annual REFERENCES provide certain highly specialised services quality reports that all hospitals must 1. World Health Organization. World on an outpatient basis. Inpatient care is publish. Health Statistics 2007. Geneva: World reimbursed through a system of diagnosis- Health Organization, 2007. related groups (DRG) per admission, What is being done to improve currently based on around 1,100 DRG efficiency? categories. The DRG system was intro- In addition to the quality measures noted ACKNOWLEDGEMENT: This article was duced in 2004 and is revised annually to above, a further set of measures aims to originally commissioned and funded by the take into account new technologies, Commonwealth Fund, New York, USA. changes in treatment patterns and asso- ciated costs into account.. New policy brief on capacity Disease Management Programmes (DMPs): legislation in 2002 created DMPs for planning chronic illnesses in order to give SFs an This policy brief published by the European incentive to care for chronically ill patients. Observatory on Health Systems and Policies DMPs exist for diabetes type I and II, reviews approaches to capacity planning in breast cancer, coronary heart disease, Canada, Denmark, England, Finland, France, asthma and chronic obstructive pulmonary Germany, Italy, the Netherlands and New disease. DMP participants are accounted Zealand. It aims to show a range of approaches for separately in the risk-adjustment mech- to health care financing and organisation, as anism for SFs, resulting in higher per they impact capacity planning. capita allocations. At the end of 2007 there The book is available for free download at: were 14,000 regional DMPs with 3.8 http://www.euro.who.int/Document/E91193.pdf million enrolled patients.
Eurohealth Vol 14 No 1 6 EUROPEAN SNAPSHOTS The health system in Denmark
Karsten Vrangbæk
Who is covered? How are revenues generated? tioners act as gatekeepers to secondary care Coverage is universal. All those registered and are paid via a combination of capi- Publicly-financed health care: a major as resident in Denmark are entitled to tation (30%) and fee for service. Hospital administrative reform in 2007 gave the health care that is largely free at the point physicians are employed by the regions central government responsibility for of use. and paid a salary. Non-hospital based financing health care. Health care is now specialists are paid on a fee for service basis. mainly financed through a centrally- What is covered? collected 'health-contribution' tax set at Hospitals: Almost all hospitals are publicly Services: the publicly-financed health 8% of taxable income. The new propor- owned (99% of hospital beds are public). system covers all primary and specialist tionate earmarked tax replaces a mixture of They are paid partly via fixed budgets (hospital) services based on medical progressive central income taxes and determined through soft contracts with the assessment of need. proportionate regional income and regions and partly on a fee for service basis. property taxes. The central government Cost sharing: there are relatively few cost allocates this revenue to five regions (80%) What is being done to ensure quality of sharing arrangements for publicly-covered and ninety-eight municipalities (20%) care? services. Cost sharing applies to dental care using a risk-adjusted capitation formula A comprehensive standards-based pro- for those aged eighteen and over (co- and some activity-based payment. Public gramme for assessing quality is currently insurance of 35% to 60% of the cost of expenditure accounted for around 82% of being implemented. The programme is treatment), outpatient drugs and corrective total health expenditure in 2005.2 systemic in scope, aiming to incorporate all lenses. health care delivery organisations and Private health insurance: around 36% of An individual’s annual outpatient drug including both organisational and clinical the population purchase complementary expenditure is reimbursed at the following standards. Organisations are assessed on private health insurance covering statutory levels: below DKK520 (no reimbursement, their ability to improve performance cost sharing from the not-for-profit organ- 50% reimbursement for children); measured against standards for standards isation ‘Danmark’. Supplementary private DKK520-1,260 (50% reimbursement); processes and outcomes. health insurance provided by for-profit DKK1,260 - 2,950 (75% reimbursement); companies offers access to care in private The core of the assessment programme is a above DKK2,950 (85% reimbursement).1 hospitals in Denmark and abroad. It covers system of regular accreditation based on In 2005, out-of-pocket payments, around 13.5% of the population and is annual self assessment and external evalu- including cost sharing, accounted for mainly purchased by employers as a fringe ation (every third year) by a professional about 14% of total health expenditure.2 benefit for employees. Some individuals accreditation body. The self assessment Safety nets: chronically ill patients with a have both types of cover. In 2005, private involves reporting of performance against permanently high use of drugs can apply health insurance accounted for 1.6% of national input, process and outcome stan- for full reimbursement of drug expen- total health expenditure.2 dards, which allows comparison over time diture above an annual ceiling of and between organisations. The external DKK3,805. People with very low income How is the delivery system organised? evaluation begins with self assessment and and those who are dying can also apply for goes on to assess status for quality devel- Government: The five regions are respon- financial assistance, and the reimbursement opment. Some quality data is already being sible for providing hospital care. They own rate may be increased for some very published on the internet (www.sundhed- and run hospitals. The regions also finance expensive drugs. Complementary private skvalitet.dk) to facilitate patient choice of general practitioners, specialists, physio- health insurance provided by a not-for- hospital and encourage hospitals to raise therapists, dentists and pharmaceuticals. profit organisation reimburses cost sharing standards. The ninety-eight municipalities are for pharmaceuticals, dental care, physio- responsible for nursing homes, home therapy and corrective lenses. In 1999 it What is being done to improve nurses, health visitors, municipal dentists covered about 36% of the population. efficiency? (children’s dentists and home dental Coverage is relatively evenly distributed In the last few years, many national and services for physically and/or intellectually across social classes. regional initiatives have aimed to improve disabled people), school health services, efficiency, with a particular focus on home help and the treatment of alcoholics hospitals. For example, Denmark has been and drug addicts. Professionals involved in Karsten Vrangbæk is Associate Professor, at the forefront of efforts to reduce average Department of Political Science, delivering these services are paid a salary. lengths of stay and to shift care from inpa- University of Copenhagen, Denmark. Physicians: self-employed general practi- tient to outpatient settings. The adminis- Email: [email protected]
7 Eurohealth Vol 14 No 1 EUROPEAN SNAPSHOTS trative reforms of 2007 aimed to enhance How are costs controlled? assessment is now an integral part of the the coordination of service delivery and to Annual negotiations between the central health system, with assessments carried out benefit from economies of scale by central- government and the regions and munici- at central, regional and local levels. ising some functions and enabling the palities result in agreement on the closure of small hospitals. The reforms economic framework for the health sector, REFERENCES lowered the number of regions from including levels of taxation and expen- fourteen to five, and the number of munic- diture. The negotiations contribute to 1. Danish Medicines Agency. New rules on ipalities from two hundred and seventy control of public spending on health by Reimbursement for Medicinal Products as of 1 April 2005. Copenhagen: Lægemiddel- five to ninety-eight. instituting a national budget cap for the styrelsen, 2005. Available at health sector. They also form the basis for The introduction of a Danish DRG (diag- http://www.laegemiddelstyrelsen.dk/publi resource allocation from central nosis-related groups) system in the late kationer/netpub/UK/reports/medicintil government. At the regional and municipal 1990s has facilitated various partially- skudsfolder_UK1/html/chapter01.htm. level, various management tools are used activity-based payment schemes (for to control expenditure, in particular 2. World Health Organization. World example, for patients crossing county contracts and agreements between Health Statistics 2007. Geneva: World borders) and benchmarking exercises. The Health Organization, 2007. hospitals and the regions, and ongoing national Ministry of Health also publishes monitoring of expenditure development. 3. Ministry of Health and Prevention. regular hospital productivity rankings. Policies to control pharmaceutical expen- Løbende offentliggørelse af produktivitet i These show that productivity in public diture include generic substitution by sygehussektoren, Tredje delrapport hospitals increased by 1.9% in 2005–06 doctors and/or pharmacists, prescribing [Continuous Public Reporting of the and by 2.4% in 2003–04.3 The total guidelines and systematic assessment of Productivity of the Hospital Sector, Third number of treatments increased by 5.5% in Sub -report]. Copenhagen: Ministry of prescribing behaviour. Health technology 2007–08.4 Health and Prevention, 2007. Available at http://www.sum.dk ACKNOWLEDGEMENT 4. Berlingske Tidende. Sygehuse effektive This article was originally commissioned and funded by the Commonwealth Fund, New som aldrig før [Hospitals More Effective York, USA. Than Ever]. 10 April 2008.
The health system in the Netherlands
Niek Klazinga
Who is covered? for care. New legislation regarding the access to health care and to compensate the Since the beginning of 2006, everyone health care costs of illegal immigrants is publicly-financed health insurance scheme resident or paying income tax in the being debated in parliament. for covering a disproportionate amount of Netherlands is required to purchase health high risk individuals. Over time, growing Prior to 2006, people with earnings above insurance coverage.* Coverage is statutory dissatisfaction with the dual system of €30,000 per year and their dependants under the Health Insurance Act public and private coverage led to the (around 35% of the population) were (Zorgverzekeringswet; ZVW), but reforms of 2006. excluded from statutory coverage provided by private health insurers and provided by public sickness funds. If they regulated under private law. The uninsured What is covered? required health insurance they could proportion of the population is estimated Services: insurers are legally required to purchase cover from private health to be 1.5%, a figure that is likely to rise provide a standard benefits package insurers. This form of substitutive private further.1 Asylum seekers are covered by covering the following: medical care, health insurance** was regulated by the the government and several mechanisms including care by general practitioners government to ensure that older people are in place to reimburse the health care (GPs), hospitals and midwives; hospitali- and people in poor health had adequate costs of illegal immigrants unable to pay sation; dental care (up to the age of eighteen; from eighteen cover is confined to specialist dental care and dentures); * The exceptions are those with conscientious objections and members of the armed forces on active service. medical aids; medicines; maternity care; ambulance and patient transport services; ** Substitutive private health insurance covers people excluded from the publicly-financed and paramedical care (limited physio- health insurance scheme.
Eurohealth Vol 14 No 1 8 EUROPEAN SNAPSHOTS therapy/remedial therapy, speech therapy, risk-adjusted capitation formula. In 2006, number of licensed specialists, in addition occupational therapy and dietary advice). the average annual premium was €1,050. to other factors. Additional funds are The government pays for the premiums of provided for capital investment, although Insurers may decide by whom and how children up to the age of eighteen. In 2005, hospitals are increasingly encouraged to this care is delivered, which gives the public sources of finance accounted for obtain capital via the private market. From insured a choice of policies based on 65.7% of total health expenditure.2 In 2000, payments to hospitals were rated quality and cost. In addition to the 2006, this proportion had risen to around according to performance on a number of standard benefits package, all citizens are 78%.3 accessibility indicators. Hospitals that covered by the statutory AWBZ (Excep- produced fewer inpatient days than agreed tional Medical Expenses Act) scheme for a Private health insurance: substitutive with health insurers were paid less, a wide range of chronic and mental health private health insurance was abolished in measure designed to reduce waiting lists. care services such as home care and care in 2006. Most of the population purchase a A new system of payment for specific nursing homes. Most people also purchase mixture of complementary and supple- treatments (DTCs) is currently being complementary private health insurance mentary private health insurance from the implemented. 10% of all hospital services for services not covered by the standard same health insurers who provide are now reimbursed on the basis of DTCs benefits package. Insurers are not required statutory cover. This has given rise to (up to 100% of all services in some to accept applications for private health concerns about the potential for risk hospitals). In future, it is expected that insurance. selection, as the premiums and products of most care will be reimbursed using DTCs, voluntary cover are not regulated. In 2005, Cost sharing: the insured pay a flat-rate although there is still considerable debate private health insurance accounted for premium (set by insurers) to their private about the desired speed of further liberali- 20.1% of total health expenditure.2 In 2006 health insurer. Everyone with the same sation of the hospital market (for example, this proportion had fallen to about 7%.3 policy pays the same premium. In 2006, an through giving hospitals greater freedom insured person was eligible for a refund of in negotiating the price and quality of How is the delivery system organised? €255 if they incurred no health care costs. DTCs). Health insurance funds: insurers are If they incurred costs of less than €255, private and governed by private law. They they would receive the difference at the What is being done to ensure quality of are permitted to have for-profit status. end of the year. This ‘no claims bonus’ care? They must be registered with the Super- system was abolished in 2007, following a At the health system level, quality of care visory Board for Health Insurance (CTZ) change of government, and has been is ensured through legislation regarding to enable supervision of the services they replaced by a system of deductibles. Every professional performance, quality in health provide under the Health Insurance Act insured person aged eighteen and over care institutions, patient rights and health and to qualify for payments from the risk must now pay the first €150 of any health technologies. A national inspectorate for equalisation fund. The insured have free care costs in a given year (with some health is responsible for monitoring and choice of insurer and insurers must accept services excluded from this general rule). other activities. Most quality assurance is every resident in their coverage area Out of pocket payments as a proportion of carried out by health care providers in (although most already operate total health expenditure have not changed close cooperation with patient and nationally). A system of risk equali- following the 2006 reforms (around consumer organisations and insurers. sation/adjustment is used to prevent direct 8%).2,3 or indirect risk selection by insurers. Mechanisms to ensure quality in the care Safety nets: children are exempt from cost provided by individual professionals Physicians: physicians practise directly or sharing. The government provides ‘health involve re-registration/re-validation for indirectly under contracts negotiated with care allowances’ for low income citizens if specialists based on compulsory private health insurers. GPs receive a capi- the average flat-rate premium exceeds 5% continuous medical education; regular tation payment for each patient on their of their household income. onsite peer assessments organised by practice list and a fee per consultation. professional bodies; as well as profession- Additional budgets can be negotiated for How are revenues generated? owned clinical guidelines, indicators and extra services, practice nurses, complex Statutory health insurance: the statutory peer review. The main methods used to location, etc. Experiments with pay-for- health insurance system (ZVW) is financed ensure quality in institutions include performance for quality in primary and by a mixture of income-related contribu- accreditation and certification; compulsory hospital care are underway. Most tions and premiums paid by the insured. and voluntary performance assessment specialists are hospital based. Two-thirds The income-related contribution is set at based on indicators; and national quality of hospital-based specialists are self- 6.5% of the first €30,000 of annual taxable improvement programmes based on the employed, organised in partnerships and income. Employers must reimburse their breakthrough method (Sneller Beter). paid on a capped fee-for-service basis. The employees for this contribution and Patient experiences are systematically remainder are salaried. In future, payment employees must pay tax on this reim- assessed and, since 2007, a national centre will increasingly be related to activity bursement. For those who do not have an has been working with validated meas- through the Dutch version of Diagnosis employer and do not receive unem- urement instruments comparable to the Related Groups (DRGs) known as Diag- ployment benefits, the income-related Consumer Assessment of Health Plans nosis Treatment Combinations (DTCs). contribution is 4.4%. The contribution of Survey (CAHPS) approach in the United self-employed people is individually Hospitals: most hospitals are private non- States. The centre also generates publicly assessed by the Tax Department. Contri- profit organisations. Hospital budgets are available information for consumer choice. butions are collected centrally and developed using a formula that pays a fixed distributed among insurers based on a amount per bed, patient volume and
9 Eurohealth Vol 14 No 1 EUROPEAN SNAPSHOTS
What is being done to improve efficiency? The health system in The main approach to improving effi- ciency in the Dutch health system rests on regulated competition between insurers, Sweden combined with central steering on performance and transparency about outcomes via the use of performance indi- cators. This is complemented by provider payment reforms involving a general shift Anders Anell from a budget-oriented reimbursement system to a performance-related approach (for example, the introduction of DTCs). In addition, various local and national programmes aim to improve health care Who is covered? How are revenues generated? logistics and/or initiate ‘business process Coverage is universal. All residents are The publicly-financed system: public re-engineering’. At a national level, health entitled to publicly-financed health care. funding for health care mainly comes from technology assessment is used to enhance central and local taxation. County councils value for money by informing decision- What is covered? and municipalities have the right to levy making about reimbursement and encour- Services: the publicly-financed health proportional income taxes on their resi- aging appropriate use of health system covers public health and preventive dents. The central government provides technologies. At the local level, several services; inpatient and outpatient hospital funding for prescription drug subsidies. It mechanisms are used, including those to care; primary health care; inpatient and also provides financial support to county ensure appropriate prescribing. outpatient prescription drugs; mental councils and municipalities through grants health care; dental care for children and allocated using a risk-adjusted capitation How are costs controlled? young people; rehabilitation services; formula. The new Health Insurance Act aims to disability support services; patient increase competition between private One-off central government grants focus transport support services; home care; and health insurers and to encourage providers on specific problem areas such as nursing home care. Possibilities for resi- to control costs and increase quality, but it geographical inequalities in access to dents to choose primary care provider and is still too early to say whether these aims health care. County councils provide hospital vary by county council. have been achieved. Increasingly, costs are funding for mental health care, primary expected to be controlled by the new DTC Cost-sharing: cost sharing arrangements care and specialist services in hospitals. system in which hospitals must compete exist for most publicly-financed services. Municipalities provide funding for home on price for specific treatments. Patients pay SEK 100–150 per visit to a care, home services and nursing home care. primary care doctor, SEK 200–300 for a Local income taxes account for 70% of visit to a specialist or to access emergency county council and municipality budgets; REFERENCES care and up to SEK 80 per day in hospital.1 the remainder comes from central 1. Maarse H. Health reform – one year For outpatient pharmaceuticals, patients government grants and user charges. after implementation. Health Policy pay the whole cost up to SEK 900 per year, Overall, public funding accounted for Monitor, May 2007. Available at: while costs above this are subsidised at 85% of total health expenditure in 2005.2 http://www.hpm.org/survey/nl/a9/1 different rates (50%, 75%, 90% and Private health insurance: about 2.5% of 100%) depending on the level of out-of- 2. World Health Organization. World the population is covered by supple- pocket expenditure. Out-of-pocket Health Statistics 2007. Geneva: World mentary private health insurance, which payments accounted for 13.9% of total Health Organization, 2007. Available at: provides faster access to care and access to health expenditure in 2005.2 http://www.who.int/whosis/whostat2007/ care in the private sector. In 2005 private en/index.html Safety nets: the maximum amount to be health insurance accounted for less than 3. Statistics Netherlands. Health and paid out-of-pocket for publicly-financed 1% of total expenditure on health.2 Welfare Statistics. Accessed 2007. Available care in a twelve month period is SEK 900 at http://www.cbs.nl/en-GB/menu/ for health services and SEK 1,800 for How is the delivery system organised? themas/gezondheid-welzijn/nieuws/ outpatient pharmaceuticals. Children are Government: the three levels of default.htm. exempt from cost sharing for health government (central government, county services. An annual maximum of SEK councils and municipalities) are all 1,800 for pharmaceuticals applies to ACKNOWLEDGEMENT: This article was involved in health care. The central children belonging to the same family. originally commissioned and funded by the government determines the health system’s Limited subsidies are available for adult Commonwealth Fund, New York, USA. overall objectives and regulation, while dental care.
Anders Anell is Professor, Institute of Economic Research, School of Economics and Management, Lund University, Lund, Sweden. Email: [email protected]
Eurohealth Vol 14 No 1 10 EUROPEAN SNAPSHOTS local governments determine how services priority setting respectively. How are costs controlled? are to be delivered based on local condi- County councils and municipalities are At the local and clinical level, medical tions and priorities. As a result, the organ- required by law to set annual budgets for quality registers managed by specialist isation of the delivery system varies at the their activities and to balance these organisations play an increasingly local level. budgets. In the past the central important role in assessing new treatment government has introduced temporary Primary care: organisation of primary care options and providing a basis for financial penalties (by lowering its grant) varies across county councils. Most health comparison across providers. Trans- for local governments that raised their centres are owned and operated by county parency has increased and some registers local income tax rate above a specified councils and general practitioners and are now at least partly available to the level. For prescription drugs, the county other staff are salaried employees. Tradi- public. Since 2006, performance indicators councils and the central government agree tionally, health centres have been respon- applied to county councils and, to some on subsidies to the county councils for a sible for providing primary care to extent, providers are systematically applied period of five years. The national Pharma- residents within a geographical area. This by the county councils in collaboration ceutical Benefits Board (Läkemedelsför- model is being replaced, with increased with the National Board of Health and månsnämnden) engages in value-based possibilities for residents to choose their Welfare. Further improvements in the pricing of prescription drugs, determining provider and physician. Primary care has transparency of national quality reimbursement based on an assessment of no formal gate-keeping function. Resi- assessment include setting up a register of health needs and cost-effectiveness. dents may choose to go directly to drug use. hospitals or to private specialists At the local level, costs are controlled by Concern for patient safety has been contracted by county councils. Increas- the fact that most health care providers are growing. The five most important areas ingly, residents are encouraged to visit owned and operated by the county with potential for improvement are: unsafe their primary care provider first. Higher councils and municipalities. Most private drug use, particularly among older people; co-payments for specialist visits are used providers work under contract with hospital hygiene; falls; routines to control to support such behaviour. Payment of county councils. Financing of health for fully avoidable patient risks; and public primary care providers is largely services through global budgets and communication between health care staff based on capitation, topped up with fee- contracts and paying staff a salary also and patients. for service and/or target payments. The contributes to cost control. Although number of private primary care providers several hospitals are paid on a DRG basis, What is being done to improve and ambulatory specialists working under payments usually fall once a specified efficiency? a public contract is increasing; in some volume of activity has been reached, which Several initiatives are being implemented county councils about half of primary care limits hospitals’ incentives to increase to improve general access to health services physicians are private. Fee-for-service activity. Primary care services are mainly and to treatment. According to an arrangements with cost and volume paid for via capitation or global budgets, agreement between the county councils contracts are more common for payment with minimal use of fee for service arrange- and the central government, all non-acute of private providers, in particular for ments. In several county councils, primary patients should be able to see a primary ambulatory specialists. care providers are financially responsible care physician within seven days, visit a for prescribing costs, which creates incen- Hospitals: almost all hospitals are owned specialist within ninety days of referral by tives to control pharmaceutical expen- and operated by the county councils. a GP and obtain treatment within ninety diture. There are no private wings in public days of the prescription of treatment by a hospitals. Hospitals have traditionally had specialist. Most county councils struggle large outpatient departments, reflecting with longer waiting times for some REFERENCES low levels of investment in primary care. patients and services (particularly for For tertiary care the county councils elective surgery). If patients are required to 1. Mutual Information System on Social collaborate in the six regions with at least wait more than ninety days they can Protection (MISSOC). Social protection in one university hospital. Private hospitals choose an alternative provider with assis- the Member States of the European Union, European Economic Area and Switzerland mainly specialise in elective surgery and tance from their county council. on 1 January 2007. Brussels: European work under contract with county councils. In primary care, residents in several Commission, Directorate General Physicians and other hospital staff are counties are encouraged to choose a Employment, Social Affairs and Equal salaried employees. Payment of hospitals provider based on their own assessment of Opportunities, 2007. Available at is usually based on DRGs (diagnosis- access and quality, with money following http://ec.europa.eu/employment_social/ related groups) combined with global the patient. A parallel policy is to increase spsi/missoc_tables_en.htm#table2007 budgets. the number of private primary care Accessed on 18 December 2007. providers and encourage general compe- 2. World Health Organization. World What is being done to ensure quality of tition for registration by residents. At the Health Statistics 2007. Geneva: World care? same time, however, there is a call for Health Organization, 2007. At the national level, the Swedish Council closer collaboration between primary care on Technology Assessment in Health Care ACKNOWLEDGEMENT providers, hospitals and nursing home (SBU) and the National Board of Health This article was originally commissioned care, particularly where care of older and Social Welfare support local and funded by the Commonwealth Fund, people is concerned. There are similar calls government by preparing systematic New York, USA. for increased integration of health and reviews of evidence and guidance for social services for mental health patients.
11 Eurohealth Vol 14 No 1 PUBLIC HEALTH PERSPECTIVES What are the prospects for a new golden era in vaccines?*
Louis Galambos
Summary: From 1945 through the 1970s, vaccines experienced a golden era in innovation, production and distribution. Paradoxically, this era was followed in the United States by a sharp contraction of the industry – the first crisis of the vaccine commons. A second crisis followed in the 1990s, and efforts to revive the industry failed. While Europe was shielded from the first crisis, globalisation and a wave of industry mergers removed that protection. Currently the UK industry is expanding and Europe now leads the world in vaccine innovation and production. The author concludes, however, that the global vaccine industry, vital to public health, is still vulnerable to another crisis created by the tendency of vaccines to become narrow-margin, high-risk commodities.
Key words: vaccines, innovation, globalisation, commodification, crises
The prospects for a new era of vaccine and high risk in the US began to squeeze reducing the risks of litigation, (principally innovation will be shaped not only by vaccine producers out of the industry. A via the US National Childhood Vaccine science and technology but also by the number of major firms left vaccine inno- Injury Act), but the cost-price squeeze political and economic environments in vation and supply. Governments were the persisted and prevented re-entry by major developed nations like the United largest purchasers of vaccines, and public pharmaceutical firms. Neither government Kingdom and the United States. The first agencies exerted downward pressure on studies nor an investigation by the golden era from 1945 through the 1970s prices. Costs increased faster than prices, National Academy of Sciences brought saw the introduction of nineteen new adding to the problems being created by relief to the industry or to a public that vaccines against a wide range of infectious liability cases. Vaccines became low-margin periodically had reason to be concerned diseases. As a result, decisive improve- commodities. Soon, only five major firms about vaccine innovation and supply. ments were achieved in life expectancy and were left in the US industry, with a study morbidity throughout the world. So bene- by Merck concluding that “No company Globalisation and the second crisis ficial were the vaccines developed in the currently not in the vaccines business In subsequent years, globalisation and a post-war years that the World Health would (logically) choose to get in.”3 wave of mergers changed the vaccine Organization (WHO) mounted two industry. The age of national champions At first, the European vaccine industry global immunisation campaigns. By the gave way to a drive to lower barriers to was protected from the changes taking end of the 1970s, smallpox was eradicated, trade. As a result of mergers, the number place in America. The major innovators and the second campaign, the Children’s of major vaccine producers in the world were developing and producing vaccines Vaccine Initiative, significantly increased actually declined further. During these for their respective national markets, and the vaccination rate among children in years, competitors in the industry also had this insulated Europe from the American developing nations1,2 (although vacci- greater freedom to develop alliances, such ‘problem of the commons’. nation rates are falling in the developing as the joint venture in the EU between countries). Efforts in the US to solve the problem Sanofi Pasteur and Merck Sharp & failed. Some progress was made in Dohme. The first crisis – the ‘vaccine commons’** Paradoxically, the golden era was followed by the first vaccine crisis. Narrow margins * The title of this article is adapted from a quote by Gregory A Poland who stated that “we are entering a new golden era of vaccinology” in an article by G Paschal Zachary, Vaccines and Their Promise Are Roaring Back, published in the New York Times on 26 Louis Galambos is Professor of History, August 2007 [http://www.nytimes.com/2007/08/26/business/yourmoney/26ping.html] Department of History and the Institute ** The ‘Tragedy of the Commons’ is a type of social trap, often economic, that involves a for Applied Economics and the Study of conflict between individual interests and the common good. It states that free access and Business Enterprise, Johns Hopkins unrestricted demand for a finite resource ultimately structurally dooms the resource University, Baltimore, MD, USA. through over-exploitation. Here, while low prices and successful liability cases benefit Email: [email protected] individuals, these ultimately lead to the decline of an industry vital to public health.
Eurohealth Vol 14 No 1 12 PUBLIC HEALTH PERSPECTIVES
It was in this setting that the second tioners, and the National Health Service on diseases that have been devastating to vaccine crisis began with a political attack (NHS) trusts all purchase vaccines.* For a the populations of developing nations. on the industry from an entirely new substantial number of their products, they Sanofi Pasteur MSD Limited combines in angle. In 1993, the Clinton Administration use restricted bidding: only those invited a joint EU-oriented venture the vaccine accused US vaccine producers of to participate are allowed to present capacity and research facilities of two preventing immunisation by charging high tenders (that is, make bids). Other vaccines leading vaccine companies. Sanofi Pasteur prices for paediatric products. There was are tendered under open procedures. Both has roots that reach back into the begin- no reliable evidence that this was true, the Department and NHS receive technical nings of modern medicine and the era of indeed there was substantial evidence to guidance on the need for vaccines, on the world’s first successful vaccines and the contrary. But legislators could not immunisation practices, the quality of serums. Sanofi Pasteur, which is the appear to be opposed to preventive vaccines, and other specific matters from vaccines division of Sanofi-Aventis Group, medicine for children, and Congress the Joint Committee on Vaccination and provided global markets in 2006 with over passed legislation to promote immuni- Immunisation, and sub-groups of experts a billion doses of vaccine directed against sation of certain selected groups of within the Committee. twenty diseases. children.4,5 Predictably, the Department and MHRA There are a number of other important After the smoke had cleared from this attempt to encourage the development of vaccine producers in the UK market. political mess, the public concern about more than one source of supply. Increased Wyeth Vaccines has introduced the world’s vaccines shifted back to the two issues that competition on the supply side increases first billion dollar vaccine: Prevenar had been of great concern in the 1980s: the market power of the monopsonist. prevents serious diseases caused by Strep- innovation and supply. The supply issue This creates a paradox because “the main tococcus pneumoniae. Wyeth also produces surfaced in 2004, when the UK’s regu- reasons for the narrow market relate to the a meningococcal C vaccine and distributes latory authority, the Medicines and high and increasing cost of vaccine devel- an influenza vaccine for the UK market. In Healthcare products Regulatory Agency opment and production, merger of manu- October 2006, Pfizer came back into (MHRA) suspended the manufacturer’s facturers and the relatively low profit vaccines by acquiring PowderMed, and licence of the Chiron influenza vaccine margins compared with other pharmaceu- AstraZeneca has acquired MedImmune plant in Liverpool, which was scheduled to tical products”.6 In that regard, the UK and with it the FluMist vaccine. The supply forty-six to forty-eight million and the US demand-side situations have suppliers of pandemic influenza vaccine doses to the US. produced similar results: in the short-term, include Baxter International Inc., and narrow profit margins; in the long-term, The Chiron problem had one prominent Solvay Pharmaceuticals is producing concentration on both sides of the market. silver lining because it was followed by a seasonal influenza vaccine. While UK decision on the part of Novartis to buy the Despite the problems of confronting biotech firms have been less aggressive share of Chiron that it did not yet own. monopsony in the UK, the major UK about vaccine research than their US coun- The Swiss firm was the type of research- firms have remained innovative – in part, terparts, several of these small organisa- oriented company with significant because globalisation leaves them less tions have entered the field in recent years. production and distribution capabilities dependent upon any single national This brief overview of the UK vaccines that the vaccine business had lost in the market. GlaxoSmithKline (GSK) is a prime industry suggests that it is on the threshold years since the mid-1970s. Novartis was global competitor and innovator in of a new era of expansion and innovation, the world’s fourth largest pharmaceutical vaccines. The company, headquartered in an era that might see the global vaccine company (based on sales in 2006) and by London, now produces a number of the commons restored. The sources of this purchasing Chiron, it became immediately important vaccines used in the UK, and its revival are not public or professional the world’s fifth largest vaccine firm. global vaccine business had sales in 2007 of reform efforts; instead, the primary factors £2 billion – an increase of 20% over the Meanwhile, a number of small research are the lower levels of innovation in phar- previous year.7 The firm’s leading products firms also entered what had become a truly maceuticals and the new science and tech- include hepatitis A and B vaccines, combi- global industry. The biotechs focused on nologies flowing from the molecular nation A/B vaccine, a new vaccine against vaccine research and development. By genetic revolution and biotech. This push human papillomavirus (HPV), and the themselves however, the biotechs were no and pull have edged some of the world’s influenza vaccine. GSK Bio currently has more able than governments or profes- large pharmaceutical firms back into the twenty-four vaccines in clinical trials – sional organisations had been to solve the business. many of them the combined vaccines that problems of supply and innovation – the facilitate immunisation.8 Both GSK and This recent transition in the industry has problem of the vaccine commons. For Novartis have, as well, tackled the thorny swung the balance in supply and to a lesser insight into what might be the solution to problems of discovering and producing extent in innovation of vaccines back that problem, we need to look into recent vaccines for the developing world. GSK toward Europe and away from the US. developments in the UK vaccine industry. Bio is working on vaccines that could be While North America is still the largest effective against malaria and Dengue fever. single market for vaccines, almost 90% of Monopsony and oligopoly in the United The Novartis Vaccines Institute for Global the world’s production now takes place in Kingdom Health is also focusing its research efforts Europe. Two-thirds of vaccine research The vaccine sector in the UK is similar to that of the US, but the demand side of the UK market is very close to being a * This section concentrates on practice in England. Health care is a devolved responsibility monopsony (with a single buyer). The in the UK and different organisational structures operate in Northern Ireland, Scotland Department of Health, General Practi- and Wales.
13 Eurohealth Vol 14 No 1 PUBLIC HEALTH PERSPECTIVES and development (R&D) is now being the long-term needs of society – the for Children: Reexamination of Program conducted by European firms. Almost all commons – as well as the short-term needs Goals and Implementation Needed to of the European investment in R&D of the governments’ budgets. Ensure Vaccination. Washington: General (22.5% of sales) comes from the private Accounting Office, 1995. Available at What are the chances that we can be sector, and almost all of it is focused on http://www.eric.ed.gov/ERICDocs/data/ successful on all three counts? The first new vaccines.9,10 If these developments ericdocs2sql/content_storage_01/0000019b proposal seems achievable in both the US continue, we may indeed have a second /80/14/72/98.pdf and the UK without radical change in golden age of vaccines. 6.Bourn J. Report by the Comptroller and either the public or private sectors. The Auditor General. Procurement of Vaccines second calls for statesmanship, a long term What are the current threats to by the Department of Health, HC 625 vision, and greater political collaboration, innovation and supply in vaccines? Session 2002–2003. London: National all of which are likely to be in greater While the vaccine industry has thus expe- Audit Office, 2003. Available at supply in the UK than in America. The rienced some encouraging changes, this has http://www.nao.org.uk/pn/02-03/ third will be the most difficult to achieve 0203625.htm not removed the threat to the global in the foreseeable future. The problem has vaccine commons. Margins will remain 7. GlaxoSmithKline. Answering the Ques- been well-defined for over two decades tight and may become tighter. Pressure to tions That Matter: Annual Review 2007. now. But the solution may require more reduce health care costs is likely to Brentford: GlaxoSmithKline, 2007. transparency, industry-government collab- continue for many years. In the UK, the Available at http://www.gsk.com/ oration and compromise than either nation medicines bill is currently under scrutiny, investors/reps07/cautionary-review.htm is capable of mustering. That being the with likely reform to the Pharmaceutical 8. The GlaxoSmithKline Clinical Trial case, we may be facing more tragedies of Price Regulation Scheme, while in the US Register. Available at: the vaccine commons. health insurance protection is declining. http://ctr.gsk.co.uk/welcome.asp There is no mechanism in either country 9. European Vaccine Manufacturers. for ensuring that each individual REFERENCES Vaccines: a Strategic Industry for Europe. purchasing organisation will not drive the Brussels, European Vaccine Manufacturers, best bargain possible for its clients. Indeed, 1. Hopkins JW. The Eradication of 2007. Available at http://www.evm- all are under significant pressure to Smallpox: Organisational Learning and vaccines.org/pdfs/brochure_April_2007_ Innovation in International Health. continue doing just that. Where they have strategic_industry.pdf Boulder: Westview Press, 1989. market power, they are likely to exercise it 10. European Vaccine Manufacturers. and once again threaten the commons. 2. Muraskin W. The Politics of Interna- Worldwide Major Vaccine Manufacturers tional Health: The Children’s Vaccine in Figures. Brussels, European Vaccine Any general economic decline that reduces Initiative and the Struggle to Develop Manufacturers, 2004. Available at public health budgets for preventive Vaccines for the Third World. Albany: State http://www.evm-vaccines.org/pdfs/mfrs_ medicine will negatively impact on University of New York Press, 1998. in_figures.pdf investment in vaccine R&D and 3. Lipmanowicz H. Vaccine Study – 1979. investment in increased capacity. As the Merck Archives; August 1979. American situation of the 1970s and 1980s This article is based on a report by Louis clearly indicated, governments are slow to 4. Galambos L. Networks of Innovation: Galambos that will be published in part- respond to structural changes in vaccines. Vaccine Development at Merck, Sharp & nership with The Association of the Dohme, and Mulford, 1895–1995. New There is often substantial political capital British Pharmaceutical Industry and the York: Cambridge University Press, 1995: to be acquired by attacking big pharma- UK Vaccines Industry Group. Financial 222–29. ceutical companies on almost any issue, support for this research was provided by including vaccines. If such attacks and 5. US General Accounting Office. Vaccines Merck Sharp & Dohme Ltd. narrower margins start another decline, the public sectors in both nations will Values in Health – From visions to reality probably be as poorly equipped as they were in the past to restore or sustain the health of this vital industry. 11th European Health Forum Gastein Does that mean we can do nothing to 1st to 4th October 2008 improve the prospects for a new golden era in vaccines? No, I think there are three measures that will help ensure a golden Inspirational goals such as 'Health for all' and 'Health in all policies' are based on seemingly shared values, but how are such values translated into policy and future in this wing of preventive medicine. practice? This will be the guiding question for the following topics at the EHFG 2008: First, we should continue to support the basic science that has been the necessary I Innovations in Coordinated Care foundation for success in vaccine R&D. I Quality & Safety Second, we should do everything possible I Equity in Health International Forum Gastein Tauernplatz 1, to counteract poorly conceived and short I Prevention & Health Professionals 5630 Bad Hofgastein sighted political and media attacks on the I Rare Diseases Austria industry. Third, we should attempt to Tel: +43 (6432) 3393 270 I Health Ethics promote in all of our public health agencies Email: [email protected] attitudes toward negotiating that recognise I New EU Health Strategy Web: www.ehfg.org
Eurohealth Vol 14 No 1 14 PUBLIC HEALTH PERSPECTIVES Access to research data in Europe
Philipa Mladovsky, Elias Mossialos and Martin McKee
Summary: The European Commission’s Seventh Framework Programme (FP7) is much more ambitious than its predecessor and health research has been boosted, taking €6 billion of the overall budget of €50.5 billion. Yet, in contrast to other leading research funders, FP7 is largely silent on the issue of access to research data. Sharing health research data is in many ways more complex than other types of research data because of the ethical and regulatory issues. However, these and other technical, legal, cultural and institutional barriers to increasing access to research data should not discourage policy development in this area, since there are many potential benefits.
Keywords: Data, Data Sharing, Research Funding, European Commission
2007 marked the beginning of the Access to research data and regulatory aspects of using infor- European Commission’s (EC) Seventh FP7 is largely silent on the issue of access mation that could, in some circumstances, Framework Programme (FP7) for research to research data. In the 1990s, European be linked to individuals. However, it is and technological development, its main legislation actually increased barriers to important that this does not create an instrument for funding research in Europe data sharing by means of the European insurmountable barrier to data exchange, over the subsequent seven years. It is much Database Directive1 which gave significant for several reasons. more ambitious than its predecessor, the copyright protection to databases. The Firstly, as a matter of principle, publicly Sixth Framework Programme (FP6), with directive benefited commercial providers funded research is a public good and a large funding increase (63% compared to with a modest, one-time growth spurt, but ensuring that research data are easily acces- FP6) and includes the creation of a it has been accused of eroding data sharing sible is primarily a matter of sound stew- European Research Council, which aims in the public domain, with particularly ardship of public resources.6 Secondly, the to fund more high-risk research at the harmful consequences for academic (and responsible sharing of data through open frontiers of science. commercial) science.2 However, a debate is access has a plethora of benefits to society. now underway within the EC, with the Health research has been boosted, taking Thus, access to survey data facilitates the Commission’s Directorate General for €6 billion of the overall budget of €50.5 development of alternative conceptual Research having organised some billion. Yet, in contrast to other leading frameworks and the ability to test new exploratory workshops on this subject and research funders, the EC has done rela- hypotheses. earmarking funding to develop and link tively little to promote access to data digital repositories and create data preser- Access to clinical trial data is important for whose collection it has financed. This vation mechanisms.3 undertaking meta-analyses, the application paper reviews the current international of enhanced econometric models and situation regarding access to research data, The lack of concrete policies on data access validity checking. It fosters a more critical focusing mainly on the field of health, and within FP7 is in stark contrast to the approach to the interpretation of results, provides a contribution to discussions on proliferation of international initiatives something which is currently perceived to future European research policies. over recent years. Initiatives to increase be lacking, particularly in relation to trials access to data have been particularly funded by the pharmaceutical industry.7–11 successful in the fields of genomics and Access to clinical trial data also confronts proteomics (the large scale study of the selective reporting of favourable Philipa Mladovsky is Research Officer proteins, particularly their structures and results, although this issue is addressed to and Elias Mossialos is Director and functions)4 and more recently in the field some extent by increasing requirements Professor of Health Policy, LSE Health of chemistry,5 but they have also been used for advance registration of protocols of and European Observatory on Health with effect in health (Box 1). Systems and Policies, London School of clinical trials, such as those by Clinical- Economics and Political Science, London, Trials.gov in the USA and the International Benefits of open access to data UK. Martin McKee is Professor of Committee of Medical Journal Editors. In Sharing data in health research is, in many European Public Health, London School Europe, as a result of the European ways, more complex than in genomics and of Hygiene & Tropical Medicine, UK. Clinical Trials Directive (Directive proteomics research, because of the ethical Email: [email protected] 2001/20/EC), since May 2004 all clinical
15 Eurohealth Vol 14 No 1 PUBLIC HEALTH PERSPECTIVES trials conducted in member states of the Box 1: Selected initiatives to promote access to research data relevant to health policy research European Union have to be registered in the EudraCT database, which is supervised United Kingdom by the European Medicines Agency. • The Economic and Social Research Council has a mandatory Datasets Policy linked to the UKDA However, this registry is confidential and (the UK Data Archive). cannot be publicly accessed. • The Medical Research Council and Wellcome Trust both require grantees to share data.
Challenges associated with open access • The National Cancer Research Institute (NCRI) aims to ensure that data generated across different to data organisations can be integrated and linked, nationally and internationally. There are, however, a number of issues that • The ‘National Strategy for Data Resources for Research in the Social Sciences’ includes plans for arise when considering data sharing at a linking different government administrative data sources with census and survey records, a European level. First, for data to be mean- methodology which is already established in other countries, such as in Canada under the Institute ingful to researchers, they will ideally have for Health Information. to be made available as individual records. It will be necessary to ensure that data are Rest of Europe anonymised before being made available; Despite the lack of explicit policy, several initiatives to improve data sharing at the European level including provisions to prevent reverse are already underway, with some receiving Framework Programme funding: processing that could allow individuals to • CESSDA (Council of European Social Science Data Archives); be identified. Complicating this issue, in some circumstances, it will be necessary • The Madiera project (Multilingual Access to Data Infrastructures of the European Research Area); for individual records to be linked to other • MetaDater (Metadata Management and Production System for surveys in Empirical Socio- data sets. This will require a mechanism to Economic Research); make this possible, while safeguarding the privacy of the individuals involved. Where • The East European Data Archive Network (EDAN); eContentplus; and European Research Obser- this is the case, it will be necessary to nego- vatory for the Humanities and Social Sciences (EROHS). tiate access and linkage on a case by case Several European datasets that are used for health research have developed provisions for shared basis since release will depend on a variety access: of factors, including the nature of consent • The European Social Survey (ESS); for data use and governance arrangements in the setting where the data were • The Survey of Health, Ageing and Retirement in Europe (SHARE); collected. This will require a complex • The European Community Household Panel (ECHP), now replaced by EU-SILC, the Survey on approval system and it remains unclear Income and Living Conditions; whether the benefits of creating a Europe- wide system to facilitate this, as opposed • Eurobarometer; to ad hoc arrangements, would be • The European Core Health Information Survey (ECHIS). outweighed by costs incurred. North America Another strategy to protect confidentiality is providing access only in a ‘safe setting’, • The American Medical Informatics Association (AMIA) initiatives to develop a national framework such as on the premises of the custodian of on the acquisition and use of health data and the Global Trial Bank; 12 the data, although this hardly seems • The Clinical Data Interchange Standards Consortium Laboratory Model (CDISC); adequate if the benefits of Europe-wide collaboration are to be achieved. Digital • The Inter-University Consortium for Political and Social Research (ICPSR); tools that provide security and control • Healthcare Cost and Utilisation Project (HCUP); access are another alternative, but these • The Canadian Association of Public Data Users (CAPDU); may be difficult to manage on a large scale. They also need to be open-source • National Institutes of Health Data Sharing Initiative. licensed.4 Furthermore, maintaining good relations with survey participants is International important, particularly in longitudinal • The International Association of Social Science Information Service and Technology (IASSIST); studies, and researchers may be wary of jeopardising this by risking a breach of • The OECD ‘Draft Recommendation Concerning Access to Research Data from Public Funding’; consent.12 Other legal considerations • The WHO International Clinical Trials Registry Platform is working on defining a minimum set of include concerns about privacy, national trial results to be reported about every trial worldwide. security, patents, royalties, time-proof rights, ownership or intellectual property icant improvement over the status quo and operability of systems at computing and rights.4, 13–16 would also mitigate the problem of semantic levels and the use of a variety of In some contexts the challenges of sharing outcomes reporting bias.7–11 storage formats. Technical and software of individual level data may be too great to standards and protocols, such as standard- A second challenge in data sharing relates overcome. However, in the case of clinical isation of methods, syntax and semantics to the significant technical barriers that trials, full disclosure and availability of all (within fields and in labelling), are needed may need to be overcome, relating to inter- summary level data would still be a signif- to ensure the access and usability of data.4,6
Eurohealth Vol 14 No 1 16 PUBLIC HEALTH PERSPECTIVES
Third, there may be cultural and institu- tutions should have to pay to access this and preservation. Brussels: Commission of tional issues, such as linguistic barriers or data. Two important academically led the European Communities, 2007, COM managerial impediments. These hurdles health related initiatives funded by FP6, (2007) 56. may include: the European Social Survey (ESS) and the 4. Lord P, MacDonald A, Sinnott R, Survey of Health, Ageing and Retirement − negotiating degrees of collaboration Ecklund D, Westhead M, Jones A. Large- in Europe (SHARE), on the other hand, scale data sharing in the life sciences: data between researchers sharing data; have taken it upon themselves to provide standards, incentives, barriers and funding − co-authorship issues; open access to data, free of charge. models (The ‘Joint Data Standards Study’). UK e-Science Technical Report Series − lack of incentives to supply data; Conclusion 2006; No 2. Available at http://www.nesc. − anticipating data sharing needs at the There are many unresolved issues in ac.uk/technical_papers/UKeS-2006-02.pdf beginning of the data lifecycle; improving access to research data. In terms 5. Baker M. Open-access chemistry data- of health research, as well as the clear − the burden of managing data sharing, bases evolving slowly but surely. Nature benefits for improving access to survey and 2006;5:707–78. for example making secondary users of clinical trial data, there are also a multitude data aware of each others’ research to 6. Arzberger P, Schroeder P, Beaulieu A, et of costs and barriers. The research avoid duplication;12 al. Promoting access to public research data community has started to address some of for scientific, economic, and social devel- − providing/explaining meta-data or logs these issues, but there remains much to be opment. Data Science Journal 2004;3(29). of research protocol to secondary users; done. As major public funders of research, 7. Sackett DL, Oxman AD. HARLOT plc: the Framework Programmes should − the lack of international standards for an amalgamation of the world's two oldest develop policies to facilitate access to data infrastructures including network professions. British Medical Journal generated by grant recipients. Since it has capacity and security of access; 2003;327:1442–45. already been launched, it may be too late 8. Smith R. Medical journals are an − the lack of international or even for FP7 to take these forward. If it is not extension of the marketing arm of pharma- national standards for data formats; possible to amend FP7, frustratingly, the ceutical companies. PLoS Medicine next opportunity is probably FP8, not due − cost of time spent negotiating data 2005;2(5 e138). to begin until 2014. sharing standards across different 9. Chopra SS. MSJAMA: Industry funding organisations; and In the meantime, steps that the EC could of clinical trials: benefit or bias? Journal of − the burden of archiving responsibil- take include: developing a framework the American Medical Association ities.4 within which clear policies on access to 2003;290(1):113–14. research data can be agreed; funding and 10. Lexchin J, Bero LA, Djulbegovic B, There may also be financial barriers, such developing European data repositories; Clark O. Pharmaceutical industry spon- as the arrangements for costs of data encouraging national and international sorship and research outcome and quality: management between disparate agencies; public funders to develop data access systematic review. British Medical Journal securing resources for data sharing activ- policies; and supporting initiatives aimed 2003;31(326):1167–70. ities from funders; and the need to antic- at understanding and overcoming tech- 11. Chan AW, Hrobjartsson A, Haahr MT, ipate the costs of data sharing costs when nical, legal, cultural and institutional Gotzsche PC, Altman DG. Empirical setting budgets. barriers to increasing access to research evidence for selective reporting of Fourth, there is the issue of quality. data. Future data sharing policy within the outcomes in randomized trials: comparison Secondary researchers will not be willing Framework Programmes can also be of protocols to published articles. Journal to make use of data unless its quality can informed by good practice manifest in of the American Medical Association be assured.4 From the perspective of the existing FP funded initiatives such as ESS 2004;291(20):2457–65. and SHARE. custodians of data and the funders of the 12. Lowrance WW. Access to Collections of research, sharing data raises questions Data and Materials for Health Research. about responsibility for ensuring the A Report to the Medical Research Council REFERENCES quality of secondary research. However, and the Wellcome Trust. London; 2006. there is no consensus on appropriate stan- 1. Commission of the European Commu- nities. Directive 96/9/EC of the European 13. Singleton P, Wadsworth M. Consent for dards, let alone how they might be Parliament and of the Council of 11 March the use of personal medical data in ensured.12 1996 on the legal protection of databases. research. British Medical Journal 2006; 333:255–58. Despite these challenges, there has been Official Journal of the European some progress in sharing health related Communities 1996:L 077, 27 March. 14. Hewison J, Haines A. Overcoming data at the European level (Box 1). The 2. Maurer SM, Hugenholtz PB, Onsrud barriers to recruitment in health research. Survey on Income and Living Conditions HJ. Intellectual property. Europe's British Medical Journal 2006; 333:300–2. (EU-SILC), the European Core Health database experiment. Science 15. Davies C, Collins R. Balancing Information Survey (ECHIS), both 2001;294:789–90. potential risks and benefits of using confi- administered by Eurostat, and Euro- 3. Commission of the European Commu- dential data. British Medical Journal 2006; barometer are coordinated by the EC and nities. Communication from the 333:349–51. provide access to data, but in some cases Commission to the Council, the European 16. Kalra D, Gertz R, Singleton P, Inskip users are charged for access. Since this Parliament, the European Economic and HM. Confidentiality of personal health research is funded by European taxpayers, Social committee on scientific information information used for research. British it is not clear why European public insti- in the digital age: access, dissemination Medical Journal 2006; 333:196–68.
17 Eurohealth Vol 14 No 1 PUBLIC HEALTH PERSPECTIVES Supporting and using policy- oriented public health research at the European level
Hans Stein
Summary: Interest in public health research in Europe, so as to provide ‘evidence-based’ policy, is growing, at both the international and national levels. Yet the links between the scientific research community and policy makers are not as close as they could be: the scientific community remains reluctant to meet policy needs; pragmatic policy-makers do not readily accept advice coming from research. Strengthening of public health research in Europe can only be achieved if a strategy is developed and implemented to bridge the gap. As part of work undertaken within SPHERE (Strengthening Public Health in Europe), this article examines how the European Union (EU) and the World Health Organization (WHO), have contributed to supported research in Europe and then makes recommendations on how links and cooper- ation could be improved.
Keywords: health policy, public health, research, Europe
Health policy activities and obligations at on request), give advice, encourage and This article reports on work to analyse the the national level are similar across promote co-operation, propose solutions, role of the EU and the WHO in public Europe. Each country has to have a health foster activities, provide information, health research conducted as part of system. There need to be laws and regula- counsel and assistance and develop inter- SPHERE (Strengthening Public Health in tions for the establishment, organisation, national standards. But while the scope of Europe, http://www.ucl.ac.uk/ public- development and funding of the system. international action is wide, the instru- health/sphere/spherehome.htm) project. Health remains a national competence: ments to achieve these aims are not well The overall aim of SPHERE was to international organisations, governments documented. There is relatively little describe European public health research and even citizens, are very much health legislation at the international level, activities, including support from interna- concerned that international institutions in although notable exceptions include EU tional institutions and national govern- their activities “fully respect the responsi- directives on tobacco and several WHO ments and to advise how policy related bilities of the Member States for the organ- international health regulations, all of research might better be integrated with isation and delivery of health service and which have to be transposed into national European health policy and practice. medical care” as indicated in Article 152 of law. the EU Treaty. Two communities: research and policy Research is the only instrument mentioned In 2006, the European Public Health Asso- This may be considered to limit the as a policy tool in both EU treaties and the ciation published ten statements on the content and character of actions by inter- WHO Constitution. Yet, perhaps surpris- future of public health in Europe.1 Three national institutions. Yet EU Treaties and ingly, while Member States look suspi- were concerned with research, empha- WHO documents confirm that these insti- ciously at all international actions in health sising that it should meet the needs of tutions can complement national health policy, until now they have shown very policy and practice, with researchers better policies, monitor and evaluate processes, little interest in health research, even interacting with politicians and practi- assist governments (though, as a rule, only though this can often go far beyond policy tioners. Although several EU Health actions. The freedom research enjoys, Council resolutions since 1999 have stated coupled with its international character that research must have an essential role in Hans Stein is based at the European and the need to make use of research in underpinning the Community’s public Public Health Centre North Rhine- health system development, suggest that health actions, little has been done to Westfalia, Germany. support for research by international insti- bridge the gap between research and Email: [email protected] tutions could strengthen public health.
Eurohealth Vol 14 No 1 18 PUBLIC HEALTH PERSPECTIVES policy. In Council conclusions (June 2006) contribute to towards overcoming these previous Council resolutions were hardly on ‘Common Values and Principles in EU obstacles and perhaps might even play a visible. There was no specific statement on Health Systems’, there was no specific leading role. the issue of cooperation and coordination reference to the EU’s 7th Research between policy and research, nor common Framework programme (FP7).2 Research Research and health as EU policies action or strategy, nor structured mecha- funded by the European Commission nisms or a permanent link and interface Research (EC) contains only a small (albeit growing) between the two areas. Consequently, number of policy related projects, inter- Fifty years ago, with the Treaty of Rome research had no formal role in under- action between researchers and politicians in 1957, neither science and technology, pinning the Community’s public health is limited, while the dissemination of nor health, were on the EU policy agenda. actions; health research and health policy research results is fragmented, project- The first steps were undertaken in both remained two independent, perhaps even related and not strategically directed at areas without a specific Community rival, areas. priority policy needs. competence. The decisive breakthrough of Public health is still not a European top a comprehensive Community strategy on Institutional and organisational differences priority. Member States remain reluctant research was made by the Single European to give the Commission a strong position Much has been written about the two Act in 1987, which brought science and in health policy affairs, particularly when communities of research and policy technology within the formal competence matters of organisation and funding of making.3 Health research and health policy of the EC. Since then, research has steadily health care are involved. The entire making have distinct organisational struc- developed into an undisputed EU key Community action programme for public tures and programmes and place a very priority on the same level as agriculture health is just €360 million over the period different emphasis on dissemination and and regional policy. The annual budgets of 2008–2013. Moreover, a decisive short- implementation. Research is often driven the research programmes have risen coming is that the programme lacks legally by scientific priorities with little regard for continuously from €3.75 million for the binding measures, or harmonisation, that policy relevance, unlike health policy FP1 programme to €50 billion for FP7 can be used to influence Member States which is usually led by legal arrangements where health (including public health) is health policies directly (laws, regulations) and often requires the the number one priority. consensus of a range of stakeholders. Yet the political context is changing; health Within FP7 one key strand is the including public health is today more Moreover, the impact of health systems programme ‘Cooperation – Collaborative accepted as a relatively important EU research, in contrast to clinical research, Research’, which includes core research policy area. This change is influenced by may have little impact on policy makers. funding of €2.45 billion for health-related growing health threats such as communi- As a consequence, many suppliers and research. Health also features in other cable diseases, including HIV/AIDS, users of social research are dissatisfied: the thematic areas: Food, Agriculture and SARS, and bio-terrorism, as well as by former because they are not listened to, the Biotechnology, and Information and health care related developments (cross- latter because they do not hear much that Communication Technologies have allo- border care, patient and professional they want to listen to. In a characterisation cated 50% and 10% of their respective mobility) triggered by European Court of of opposing perspectives the research budget to health topics. The focus of the Justice rulings. The Commission’s Public community “asks questions we already EU health research programme continues Health Strategy leaves room for links with know the answers to”, while the policy to be biomedical research including the research, if there is political will and, more community “wants simple answers to “strengthening of the competitiveness” of importantly, power for action. The difficult questions delivered yesterday, industry. However, public health research programme contains the possibility of proposing answers that will lead to results is considered in a one programme strand joint strategies and actions in other tomorrow, costing as little as possible”. “Optimising the Delivery of Health Care unnamed sectors. to European Citizens”, which has three Similarly, the former editor of the British components: translating clinical research Medical Journal, Richard Smith in Links between public health research into clinical practice (medicines, behav- describing the “disconnect between and public health policy ioural and organisational interventions, practice and research” observed that The need for close links between research and health technologies); quality, efficiency researchers value basic science, discovery and policy at EU level, as well as mecha- and solidarity of health care systems and originality, while practical questions nisms to set research priorities, have long (health systems); and enhanced health are seen as dull, unoriginal and “unim- been expressed in conferences, workshops promotion and disease prevention. There portant in scientific terms”.4 He noted that and official EU documents. For instance, is also support for ‘horizontal’ research, there is often no mechanism to transmit in 1994 in Celle, Germany, a meeting including a section on policy implemen- the questions of practitioners to discussed the development of a European tation. researchers, while scientists are wary of public health research strategy that would directed research and health policy may Public health both respect the need for high quality boast that they do not make use of research research and fit public health policy objec- The development of public health as an results. At both a national and interna- tives and needs in relation to FP4 and EU policy area has followed a similar path tional level the differing interests of the BIOMED II. While a meeting was to research. It took more than three years principle stakeholders in the research and proposed between Commission DG for the EU to agree a budget for the first policy making communities have been Research, DG Health (Sanco) and Celle, it Public Health Programme in 2002. The strong enough to block real changes in the was not forthcoming. Similarly, a recom- links between research and policy that had past. Cooperation across Europe could mendation that the Commission should been considered necessary by experts and
19 Eurohealth Vol 14 No 1 PUBLIC HEALTH PERSPECTIVES develop mechanisms for establishing fields”. Activities to be pursued included This was grouped with other targets, appropriate working partnerships with an exchange of information, setting up of including the creation of health and health- public health authorities at European and databases, as well as joint analysis, related information bases to support moni- national levels was not implemented. financing and participation in committees toring and evaluation of health policies; and working groups. and the use of the media and communi- Another conference at Potsdam in 1999, cation sector to “inform, educate and under the German presidency, entitled The At a European level the WHO Regional persuade all people”. new public health policy of the European Office for Europe developed a Health for Union, contained a working group on the All Strategy in 1984. This contained a very Acknowledging that “only a few” Member contribution of research to EU public ambitious target that “before 1990, all States had followed the advice given by health policy. It acknowledged that better Member States should have formulated WHO on health research policies and coordination of research and health actions research strategies to stimulate investiga- programmes, and that “hardly any country would greatly improve the quality of tions which improve the application and has a systematic mechanism for ensuring research and dissemination of results, but expansion of knowledge needed to support that new evidence from research is actually again there was no follow up. their Health for All developments”.5 introduced into daily practice”, it encouraged international research collab- In Granada, in 2002 under the Spanish The target called for Member States to oration at the European level to be presidency, a conference entitled Research develop mechanisms for: strengthened. An emphasis was placed on in the health systems of the European – effective application of new knowledge needs-based research, an increase in the Union: needs and priorities recommended in the development of health policies number of inter-country research that research should be based on health and programmes; programmes and better exchange of needs, while health policies should be research information. based on research results. It called for – identification of knowledge gaps; multi-institutional and multidisciplinary The Health for All strategy was last – setting research priorities; co-operation networks, with their own updated in September 2005 in Bucharest. agendas for research priorities, focussing – involving health policy makers in the This revision makes little reference to on the context for application, on health planning and coordinating of research; research.7 Indeed both revisions of the problem solving, and promoting a Health for All Strategy since 1984 suggest – stimulation multidisciplinary research; permanent exchange of knowledge and that the extent of the problems in fostering technologies, with evaluation criteria – allocation of sufficient resources to research may have been underestimated taking a predominant role, and where conduct the research needed. and the potential to overcome them over- social relevance was considered alongside estimated. Whereas all countries, even the The WHO strategy paper also recom- scientific quality. smallest, now have health systems and mended clear (national) strategies for policies that provide for health promotion Later that year, the Commission (three Health for All, as well as (national) and care for the whole population, many directorates -- Research, Employment and research strategies, both drawn up by countries still do not have the capacity for Social Affairs, and Health and Consumer government bodies. It stated that scientists health research. Even in those countries Protection) organised a joint workshop to and health policy makers should regularly where capacity exists, research priorities “bring together a broad range of experts, review new knowledge emerging from are often determined independently and in researchers and administrators to discuss research that could be of use for health a rather rigid fashion, rather than being set how European research collaboration can policies and health care programmes. This by specific policy sectors or international be developed and what types of health and ambitious, but somewhat unrealistic target institutions. social policies can best be addressed using was not achieved, perhaps illustrating cross-national research”. There was perfectly what does not work! While targets related to research have not consensus that many policy issues been accomplished, this does not mean In 1998, the WHO policy framework was provided a large agenda for research and that research should be dropped. Targets updated in accordance with the ten targets that research programmes should provide may be modified in a realistic way, taking adopted by the World Health Assembly in relevant, well-focused inputs into the into account the limited capacities in many 1998. The new document, Health21 – the policy cycle, to ensure that the results have countries, as well as the growing interna- Health for All Policy Framework for the an impact on policy decision- making. tional cooperation on policy-related health WHO European Region, reduced the research, including financial and personal original thirty-eight health targets to The role of WHO in health research resources. Indeed today the research aims twenty-one.6 It stated that the EU was “an The WHO has long played an important of WHO are much more pragmatic: to international organisation with a strong role in health research and has co-operated influence the research agenda, especially at mandate for multi-sectoral action for on this issue with the European a national level, identifying research needs health that has a large potential for Commission since the early 1970s. More and gaps; making use of research evidence contributing to this development”. A new recently, a Memorandum on the for its own decisions and in providing target focused on Research and Knowledge framework and arrangements for cooper- advice and recommendations to its for Health. It stated that “by the year 2005, ation between the two organisations was Member States. These aims could represent all Member States should have health published in 2001. It noted the importance a WHO contribution to greater interna- research, information and communication of “promoting health-related research and tional cooperation, acting as a ‘neutral systems that better support the acquisition, technological development, taking stock of broker’. effective utilisation, and dissemination of its results and developing advice on appli- knowledge to support Health for All.” cations in the health and health-related
Eurohealth Vol 14 No 1 20 PUBLIC HEALTH PERSPECTIVES
Strengthening public health and public nation and implementation of results. At all function. Action can be led by the Council health research of these stages there needs to be co-oper- of Ministers who, together with the There are no clearly defined criteria on ation between researchers and policy European Parliament, exercises legislative how the strengthening of public health makers. The present situation, where and budget functions. policy makers highlight relevant research research could be measured. Several There should be agreement between the issues and then wait patiently for many criteria might be considered as signs of different European institutions on long- years before receiving (perhaps outdated) improvement, including greater priority, term strategic goals and targets for health, results, is satisfactory neither for policy, resources, funding and outputs for public as well as short-term priorities for both nor for research. Pragmatically this might health research, as well as increased appli- health and research. These objectives could be improved through better use of existing cation in policy making. be achieved by a strategy or white or green research mechanisms and structures. Using these criteria there can be little paper submitted by the Commission to the doubt that in the past twenty years the Subsidiarity Council of Ministers and European Parliament for endorsement or activities of the EU and WHO have made The decisive criterion for justifying such amendment. This process is already used a positive contribution. There has been a EU activities is that they can only be better for other policy areas that receive research substantial upgrading of public health achieved at an international rather than at support. Once a strategy was agreed, research at a political level – internationally national level. Subsidiarity is one of the implementation would be facilitated as well as nationally. A great variety of fundamental principles of the EU and the through appropriate legal and adminis- international projects have increased basis for all international activities. The trative instruments. In respect of research, knowledge and broadened the evidence extent to which public health activities are this would be within the Framework base in a way that national projects alone consistent with this principle continues to Research Programme through its thematic could never achieve. EU-funded research be the subject of debate, but there can be programmes, whilst in respect of public programmes have contributed to an no doubt that public health research as a health policy there would be the action increased investment of financial, profes- whole meets this requirement. Some programme or binding legal measures such sional and structural resources, not only at European countries, especially the smaller as regulations or directives. The new international, but also at a national level; ones, may not be able to establish and Health Strategy as proposed by the while international cooperation has led to implement full public health research Commission in its White Paper "Together new structures and institutions. strategies, or at best only develop indi- for health" and presently being discussed The Health in All Policies movement of the vidual projects. The failure of Member at the Council is a step in this direction, EU, in combination with the WHO States to implement the (albeit over-ambi- but by itself does not solve the problem. Health for All Strategy, with its approach tious) WHO research targets shows this for integrating health into relevant clearly. The work programme, as well as the call for proposals, should contain more European policies and with its analytical There is a growing consensus that some detailed information about the policy and scientific roots, cannot however be future efforts should be made at an inter- context, especially research needs and implemented without strong support from national level, enabling research otherwise expected research impact. The present the public health sciences. Shortcomings not possible on a national scale to be practice of referring to the policy context remain. There is little integration of policy conducted, and in turn permitting all by just naming policy documents is insuf- needs into priorities setting for research Member States to benefit from the ensuing ficient. In the same way, health policy programmes, reflecting a lack of cooper- research results. The principle of documents should describe research more ation and common strategic approach. The subsidiarity thus not only provides a legal specifically and not just refer to the use of research evidence in policy making justification for EU public health research, Framework Programme. In some cases, has been limited. While FP7 names “rein- but also a political mandate and obligation. calls for proposals describe a project in forcing health-policy driven research” as The progression of EU public health great detail, while in others the description one of its aims, and has also significantly research over the last two decades, which is quite general. Unless the research increased the topics and projects aimed at has culminated in health as a priority area requirements of a policy are very specific, “underpinning informed policy decisions”, of FP7, illustrates how this can be this should leave sufficient room for inno- this is neither the “clear strategy” nor achieved. “joint action” proposed by experts and vative ideas and solutions. Structures supported by the EU Health Council for Dissemination many years. Furthermore no common Full or partial integration of public health High quality research is not enough: mechanisms have been established. It is research with health policy structures at effective dissemination of results and obvious that national research administra- European level is not recommended. establishment of trusted policy links and tions are willing and able to fund policy- Instead, cooperation and consultation contacts are essential to the success of a related projects, but they are not willing to should be strengthened between research policy-related research project. Quite change their structures and integrate the and policy, making use of existing struc- often, especially at the European level, policy process. tures and mechanisms. In the case of the researchers lack the knowledge and expe- EU, the highest policy-making institution The application of research results to policy rience on how this could best be achieved. would be the European Council (Summit). needs is done through a continuous, long Past experience could be used to establish This body provides the EU with the term and interrelated process with many standard criteria and procedures. different stages from initial development of necessary impetus for its development and a research programme through to dissemi- defines general political directions and Conferences or workshops might be used priorities, but does not have a legislative to promote an exchange of experience with
21 Eurohealth Vol 14 No 1 PUBLIC HEALTH PERSPECTIVES the results published as a handbook to 2. Council of the European Union. and Priorities. Granada, Spain: 2002. guide future projects. This would be espe- Council conclusions on common values 5. World Health Organization. Health For cially helpful for inexperienced first time and principles in European Union health All Targets. Copenhagen: World Health applicants unfamiliar with the policy systems. Official Journal of the European Organization Regional Office for Europe, context at the EU level. Better links with Union 2006; C 146/01. Available at 1984. policy could be established through the http://eur-lex.europa.eu/LexUriServ/ 6. World Health Organization. Health 21 – participation of policy experts/ represen- LexUriServ.do?uri=OJ:C:2006:146:0001:00 03:EN:PDF Health for All in the 21st Century. tatives as full partners in projects. They Copenhagen: World Health Organization might be responsible for the policy context 3. Innvaer S, Gunn V, Trommald M, Regional Office for Europe, 1999. and provide information about changing Oxman A. Health policy-makers’ percep- 7. World Health Organization. The Health political developments and needs. Apart tions of their use of evidence: a systematic for All Policy Framework for the WHO from the (usually very lengthy) official review. Journal of Health Services Research European Region. Copenhagen: World report of a project, targeted publication of and Policy 2002;7:239–44 Health Organization Regional Office for key findings is an essential element of any 4. Smith R. Reflections of an editor on Europe, 2005. Available at dissemination strategy. This should be research and policy. Presentation at http://www.euro.who.int/document/ specified along with key target audiences conference on Research in the Health e87861.pdf to be reached in the project proposal itself. Systems of the European Union – Needs Additional efforts may have to be made to create a new kind of link between research ACKNOWLEDGEMENTS and policy at the project level. Activities for This article is an abridged version of the contribution of one work package within SPHERE this purpose might include regular health (Strengthening Public Health Research in Europe, Coordinator, Professor Mark McCarthy) policy conferences aimed at exploring and and supported by the European Community’s Sixth Framework Programme for Research identifying future challenges for health (contract FP6-513657). More information at http://www.ucl.ac.uk/public-health/sphere/ systems, including health services; and spherehome.htm projects aimed at “brokering research into policy” intended to transfer new as well existing knowledge into policy initiatives. Health sector experts address the Conclusions Tremendous progress in policy-related importance of strategic purchasing public health research has been made in In May 2008, the World Bank in collabo- Typically, these policies have to answer: Europe in the past three decades. It has ration with the WHO, the European firmly established itself as an area whose − what areas of performance are Observatory on Health Systems and objectives cannot be achieved by indi- important; Policies, and the Center of Excellence in vidual countries alone, it needs interna- Finance organised a two-day workshop on − who will make the purchases of what tional cooperation. This is demonstrated ‘Strategic Purchasing’ in Bled, Slovenia. and for what groups of people. through the high priority given to health within FP7, while research has contributed The workshop focused on: There are several governance tools for to public health activity, the development strategic purchasing, including quality − Strategic purchasing: analysing the rela- of EU health policy and international councils; report cards or scorecards; and tionship between providers and cooperation. performance-management instruments, discussing the contextual factors as well such as accountability agreements and Despite this progress, this is not a total as the tools influencing its performance; provider profiling. The workshop focused success story. The ambitious objective that − Governance of strategic purchasing: on how strategic purchasing works in the every country should have a formulated focusing on the relationship between context of single or multiple and public or public health research strategy has not been the Ministry of Health and health private insurance systems; as well as how achieved. The integration of policy needs insurers, highlighting the regulatory strategic purchasing is influenced by into research programmes and the use of environment required for ensuring that contextual factors such as growing research results in policy decision-making, strategic purchasing aligns with health shortages of providers, increased consumer can be improved. In particular, the mecha- priorities and targets. choice and competition regulation. nisms for interaction between research and policy remain a challenge. The way Strategic purchasing refers to a coherent set Presenters included: Josep Figueras forward is greater collaboration between of incentives for providers through (European Observatory), Maureen Lewis the EU, Member States and the WHO. contracting and the provider payment (World Bank), Tamás Evetovits (WHO) mechanisms to encourage them to provide and Pia Schneider (World Bank), along the best available treatment in a cost- with prominent presenters from Estonia, REFERENCES effective manner. It also requires incentives Hungary, Iceland, Ireland, Macedonia, the 1. European Public Health Association. 10 and managerial capacity on the purchasers’ Netherlands, Portugal, Slovenia and the Statements on the Future of Public Health side to engage in effective strategic Slovak Republic. in Europe. Brussels: EPHA, 2006. purchasing policies. Available at http://www.eupha.org/doc/ EUPHA_10_Statements.pdf The presentations are available for download at http://www.cef-see.org/index.php?location=634&sublocation=860&nId=68
Eurohealth Vol 14 No 1 22 HEALTH POLICY DEVELOPMENTS Celtic Tiger, Health Care Dragon: Fiery debates in the Irish private health insurance market
Brian Turner
Summary: The Irish private health insurance market covers over 50% of the Irish population, despite universal access entitlements to the public health care system. Having had a monopoly for forty years, the statutory insurer, VHI, faced compe- tition following deregulation in the mid-1990s. Currently there are three insurers competing in the market, and a number of regulatory measures have generated much debate. In particular, the introduction of risk equalisation and VHI’s differential prudential regulatory regime are being challenged.
Keywords: Private health insurance, Ireland, risk equalisation, prudential regulation
The Irish private health insurance (PHI) the main reasons underlying the high insurers must charge the same premium. market was formally established by the penetration rate include a belief that PHI Therefore age, gender, current or Voluntary Health Insurance Act, 1957. gives consumers faster access and better prospective state of health, or any other This Act established the Voluntary Health services, and a widespread lack of confi- factor which may reflect the risk a Insurance Board (VHI), which was dence in the public health care system. consumer represents to an insurer, may not intended to provide voluntary health PHI is seen by most people as a necessity be taken into account when setting insurance to the top 15% of earners who, rather than a luxury and as providing peace premiums or determining benefits. at that time, were not entitled to free access of mind. Open enrolment means insurers cannot to the public hospital system. Since then, refuse cover to anyone, although they may access entitlements have been broadened, Legislative foundation impose three types of waiting periods, for and currently all Irish residents are entitled The Irish PHI market is based on the three initial applicants, pre-existing conditions to free, or almost free, access to public ‘pillars’ of community rating, open and upgrades in cover. The maximum hospital accommodation and treatment by enrolment and lifetime cover. Under permitted waiting periods are age-related, public hospital consultants. Despite this, community rating, insurers are prohibited which gives insurers some protection the take-up of PHI has far exceeded the from varying premiums or benefits against hit-and-run or hit-and-stay originally anticipated 15%, and currently between consumers subscribing to the behaviour by consumers. Lifetime cover over two million people, or more than same plan, subject to certain exceptions, mandates that once a consumer has PHI an 50% of the population, are covered by such as permitted discounts for children, insurer cannot refuse to renew cover, PHI, paying almost €1.25bn in premiums students and members of group schemes, except in very limited circumstances. The in 20061 (see Table 1). although within each of these categories According to two surveys2,3 carried out on behalf of the Health Insurance Authority Table 1: Membership and premium trends, 2001–2006 (HIA) – the independent statutory regu- latory body for the industry in Ireland – Year 2001 2002 2003 2004 2005 2006
Brian Turner was formerly Head of Membership Research/Technical Services at The 1,871 1,941 1,999 2,054 2,115 2,174 Health Insurance Authority and is (000s at end-of-year) currently a part-time lecturer and full- Premiums time PhD student at the Department of N/A 821.9 978.2 1,061.1 1,152.7 1,236.2 Economics, University College Cork, (€m full-year) Ireland. Email: [email protected] Source: Health Insurance Authority, 20071
23 Eurohealth Vol 14 No 1 HEALTH POLICY DEVELOPMENTS combination of open enrolment and owing to the triggering of risk equalisation to the Irish Supreme Court, which heard lifetime cover means that consumers may payments. In early 2007, the Quinn the case in November 2007, although switch between insurers without penalty, Group, which already operated in other judgment has been reserved. In the in particular without having to serve addi- non-life insurance markets in Ireland, took meantime, a stay remains on payments tional waiting periods other than any they on BUPA Ireland’s business, which is now under the scheme. BUPA Ireland currently might already be serving with their trading as Quinn Healthcare. Although a has two cases pending in the Irish courts, previous insurer. number of relatively small restricted including the Supreme Court appeal, while membership undertakings (for example, Quinn Healthcare also has two cases In addition to these ‘pillars’, there are regu- for the police and Electricity Supply Board pending, one challenging the risk equali- lations specifying a set of minimum workers) are in operation, Quinn sation scheme, the other challenging emer- benefits that any eligible health insurance Healthcare, VHI and VIVAS Health are gency legislation that was passed in early plan must cover. This is primarily designed the only three insurers operating in the 2007 to close a loophole that could have to ensure that consumers do not under- open market for PHI in Ireland. Approx- allowed Quinn Healthcare to benefit from insure due to a lack of information or imate market shares are 73% for VHI, a three-year exemption for new entrants understanding. In order to safeguard 20% for Quinn Healthcare and 7% for from risk equalisation payments. community rating, a risk equalisation VIVAS Health. scheme was also brought forward. This Prudential regulation aims to equitably neutralise differences in Having had a monopoly for forty years, The other main source of tension is the insurers’ claims costs resulting from VHI had built up a substantial customer prudential regulation of competing differing risk profiles, by obliging insurers base prior to deregulation. Since then, insurers. When VHI was established, it with lower-risk membership profiles to many of these customers have stayed with was exempted from the application of the pay into a risk equalisation fund, adminis- VHI, with relatively few switching Insurance Acts in Ireland. In amending tered by the HIA, from which payments provider. The HIA’s second consumer legislation to the 1957 Act, it was also are made to insurers with higher-risk survey showed that, by 2005 – eight years given the opportunity to engage in other membership profiles. after the introduction of competition – activities besides its core health insurance only 10% of consumers had ever switched This scheme was first introduced in 1996, business, subject to approval from the their health insurer, mostly from VHI to but transfers were never made and the Minister for Health and Children. In BUPA Ireland. It also showed that regulations governing the scheme were recent years, VHI has begun selling travel switchers tended to be younger than revoked in 1999. A new scheme was estab- insurance and dental insurance, operating average consumers when they switched. lished pursuant to the Health Insurance an online health shop and establishing (Amendment) Act, 2001, and came into minor injury clinics. Risk equalisation force on 1 July 2003. In October 2005, the The first market feature that has caused In practice, this means that VHI is not HIA recommended the commencement of considerable controversy was the intro- currently subject to the prudential require- payments under the scheme and the duction of risk equalisation. In practice, ments applying to other non-life insurers Minister sanctioned the commencement of BUPA Ireland/Quinn Healthcare and in the Irish market. Prior to BUPA payments, beginning on 1 January 2006. VIVAS Health were/are net contributors Ireland’s withdrawal from the market, each There is broad cross-party parliamentary to the risk equalisation fund, while VHI of the three insurers in the market was support for the legislative ‘pillars’ on and one of the restricted membership subject to a different supervisory regime, which the market is based, and also for risk undertakings are net recipients. with BUPA Ireland regulated by the equalisation, though perhaps not quite as Financial Services Authority in the UK, Although the original scheme was in place broadly-based for the latter. VHI overseen by the Minister for Health when it entered the market, BUPA Ireland and Children and VIVAS Health regulated was strongly opposed to risk equalisation Development of competition by the Financial Regulator in Ireland. on the basis that it would be required to In 1992, the European Third Non-Life Since Quinn Healthcare’s entry to the make payments to VHI, which it saw as Insurance Directive obliged EU Member market, it too is regulated by the Financial having a dominant market position. States to open their non-life insurance Regulator. From a health insurance stand- Following a complaint from BUPA markets to competition from insurers point however, all health insurers are regu- Ireland, the European Commission based in other Member States. This lated by the HIA. examined whether risk equalisation in the directive was transposed into Irish legis- Irish market constituted illegal state aid What the differential prudential regulatory lation by the Health Insurance Act, 1994. and decided in 2003 that it did not, thus requirements mean in particular is that This Act, and associated regulations, paving the way for the introduction of the VHI is not required to hold the level of formalised the principles of community 2003 scheme. BUPA Ireland challenged solvency reserves that its competitors must rating, open enrolment and lifetime cover, the Commission’s decision in the hold (equating to 40% of premium which VHI had previously been operating European Court of First Instance, but in a income), although it has built up its on a de facto basis. judgment delivered in February 2008 the reserves in recent years in anticipation of Subsequent to the opening of the market Court dismissed this challenge. the removal of this derogation. It is also to competition, BUPA Ireland began claimed that VHI’s ability to engage in BUPA Ireland also challenged the legality selling health insurance in 1997. VIVAS other activities gives it an advantage, as its of the scheme in the Irish courts, and in a Health entered the market in 2004. In late competitors would have to set up judgment delivered in November 2006, the 2006, BUPA Ireland announced its subsidiary companies if they wished to do High Court dismissed BUPA Ireland’s decision to withdraw from the market so. case. BUPA Ireland appealed this decision
Eurohealth Vol 14 No 1 24 HEALTH POLICY DEVELOPMENTS
Following a complaint from VIVAS Health, the European Commission has Governance in the insisted that VHI’s derogation be removed. Such a change was mooted some time ago, as outlined in a White Paper produced by pharmaceutical sector the then government in 1999,4 but not acted upon. Legislation to put this into effect is currently being debated in parliament.
Where do we go from here? Armin Fidler and Wezi Msisha While risk equalisation has been given legal backing by the Irish High Court and the European Court of First Instance, the Summary: Pharmaceutical products are an important element of health Supreme Court judgment is still awaited, systems that often make a difference in health outcomes, particularly for and it remains to be seen whether the the poorest people. Despite this, global inequalities in access to pharma- Court of First Instance judgment will be appealed to the European Court of Justice. ceuticals persist, due to a number of factors including poor governance Further legal challenges are also pending in and corruption. This article provides a general overview of the pharma- the Irish courts, and Sean Quinn, ceutical sector’s vulnerability to corruption, reviews initiatives to Chairman of the Quinn Group, has vowed improve governance in this sector within the Eastern Europe and to continue fighting risk equalisation. Central Asia region and concludes by making recommendations for further addressing this issue. The legislation being debated in the Irish parliament aims to oblige VHI to meet the same prudential regulatory standards as its Key words: Governance, Corruption, Pharmaceuticals competitors by the end of 2008. It is not yet clear whether this will satisfy the European Commission, which gave the Irish government two months from Pharmaceuticals are an indispensable governance.3 Indeed, corruption has been November 2007 to comply. ingredient of modern health technology identified by development practitioners as and as such also constitute an important one of the most important obstacles to It would appear therefore, that whatever and increasing share of health expenditures economic and social development, as it the short-term outcomes, it could be some globally. In many transition economies in distorts the rule of law and weakens the time before these issues, and in particular Europe the allocation for pharmaceuticals institutional foundations which are risk equalisation, are fully resolved. routinely exceeds a quarter of the annual necessary for economic growth. Impor- health budget. For economic and health tantly, the poor are the ones most affected impact reasons, sound pharmaceutical by bad governance and corrupt practices REFERENCES policies and regulations, minimum quality as they often depend on the provision of 1. Health Insurance Authority. Annual standards for drugs, transparent licensing, public services and are least able to afford Report and Accounts 2006. Dublin: The registration and procurement and the costs associated with bribery and Health Insurance Authority, 2007. evidence-based prescription practices are a fraud.4 2. Amárach Consulting. The Private concern for both consumers and policy For these reasons the World Bank has Health Insurance Market in Ireland. makers. Good governance and absence of come up with a new strategy and plan for Dublin: The Health Insurance Authority, corrupt practices is important for the strengthening its engagement with and 2003. performance of health systems in general, support for client countries on these issues. and international evidence shows that 3. Insight Statistical Consulting. The Since the mid-nineties, the World Bank’s governance break-downs and corruption Private Health Insurance Market in world-wide “Governance Indicators Ireland: A Market Review. Dublin: The in the pharmaceutical sector has serious Project”5 has periodically reported on Health Insurance Authority, 2005. negative repercussions for the effectiveness individual and aggregated governance indi- of the health system in general.1,2 4. Department of Health and Children. cators covering six aspects: (i) voice and White Paper: Private Health Insurance. accountability; (ii) political stability and The importance of governance in public Dublin: Government Stationery Office, the absence of violence; (iii) government policy and development 1999. effectiveness; (iv) regulatory quality; (v) The World Bank renewed its commitment rule of law; and (vi) control of corruption. to focus on governance and anti- This exercise covering 212 countries allows corruption as a key development challenge assessment of their progress on these and has developed a new strategy on good governance aspects.5 Good governance in
Armin Fidler is Health Sector Manager, Europe and Central Asia Region and Wezi Msisha, Health Specialist, Europe and Central Asia Region, The World Bank, Washington DC, USA. Email: [email protected]
25 Eurohealth Vol 14 No 1 HEALTH POLICY DEVELOPMENTS all sectors has therefore emerged as a The value of the global pharmaceutical they are with other products due to infor- crucial aspect of the global development market is estimated at over US$500 billion, mation asymmetry between consumers agenda, as it has been shown empirically to making the pharmaceutical sector highly and prescribers. There is a significant level affect income levels, economic growth and lucrative but also increasingly vulnerable of governmental involvement required in macroeconomic policies. One of the key to corruption and unethical practices. regulating this sector, therefore creating areas in the fight against poverty is to Because of their therapeutic and curative increased opportunities for corruption and invest in human capital, which entails qualities, access to quality pharmaceuticals mismanagement due to the breakdown of improvements in the social sectors, partic- oftentimes means the difference between ethical business practices after the tran- ularly education, social protection and life and death. Despite this, poor access to sition. All too often it has been shown that health. drugs remains a major global health in many transition economies, checks and problem with close to two billion people balances and governance and business Governance is a critical element in the or one third of the global population processes are not transparent and only a management of health systems lacking regular access to essential medi- few individuals exercise a high level of Global research has shown that wide cines. discretion in decision-making, allocation discretion, lack of transparency in decision of resources and staffing of key posts. According to World Health Organization making and lack of accountability for deci- (WHO) estimates, approximately ten Other growing challenges are market sions made are some of the conditions that million lives could be saved every year distortions and counterfeit drugs. In many create opportunities for corrupt practices through the improvement in access to transition countries with emerging phar- and increase the likelihood of governance essential medicines and vaccines.9 Several maceutical markets and weak government breakdowns.6 Good governance within factors contribute to the problem of regulatory capacity (and virtually no self health systems and accountability of unequal access to pharmaceutical products regulation by professional associations, service providers are therefore essential for and these include market failures, such as doctors, pharmacists, or whole- functioning health systems to deliver government inefficiencies, costly drug salers of drugs), aggressive marketing tech- preventive and curative services to their constituency and hence contribute to improved health outcomes. According to Transparency International, “ten million lives could be saved every year through the more than US $3 trillion is spent on health services globally each year.2 But on improvement in access to essential medicines and vaccines” average, 10–25% of public procurement spending in the health sector is lost to corruption. Despite increasing awareness of the consequences of poor governance in prices, poverty, poor health infrastructure niques by physicians for specific drugs, general, the specific issue of governance in and corruption. Transparency Interna- lead to a high rate of prescriptions that are health care has somehow received less tional estimates that globally two thirds of not based on medical evidence, best global attention thus far. Recent work on medicine supplies in hospitals are lost practice or the patients need. corruption in the pharmaceutical system7,8 through corruption and fraud.2 Unscrupulous importers, wholesalers and has highlighted the particular importance distributors tend to maximise their profits A governance breakdown in the pharma- of governance in the pharmaceutical area and exploit unregulated or under-regulated ceutical sector not only generates a as an important element within the health markets. Similarly, corruption and taking negative economic impact but also puts at sector and its important contributions to advantage of weak regulatory and risk the health gains of patients. A more health care and health status in general. As enforcement capacity underpins the intangible side effect of inefficiency and a result, this has become a priority concern lucrative counterfeit drugs trade. lack of transparency and corrupt practices of international agencies and foundations. is that it undermines the credibility of Payoffs at every step of the supply chain public institutions and erodes public and allow the flow of counterfeit drugs from Governance and the pharmaceutical donor confidence in government capacity. their source to consumers in many tran- system Not surprisingly, in the opinion of sition economies, with a particular Pharmaceuticals are a critical, high value European citizens in transition economies, problem arising in Central Asian coun- input for health delivery systems that often the public health system was perceived as tries. With pharmaceuticals often being the make a difference in health outcomes for the public service institution where largest household health expenditure in individuals and an entire population. corruption occurred most frequently developing countries, (often more than Access to high quality medicines is a non according to results from the recent Life in 50% of total individual out of pocket trivial issue, especially for disadvantaged, Transition Survey conducted in Eastern health expenses) corruption in the phar- poor and vulnerable populations. Despite Europe and Central Asia.10 maceutical industry has a direct impact on international aid, the advent of specialised low income patients.11 agencies and funds (such as the Global The procurement and sale of pharmaceu- Fund to Fight AIDS, Tuberculosis and tical products (together with other high Finally, the complex processes and the Malaria) and many government sponsored technology investments in health) is a many steps involved in the pharmaceutical or donor programmes devoted to lucrative business in most countries, supply chain in order for drugs to get from improving global pharmaceutical access, because of the high value of the goods production to market to the final there is still a concerning drug supply gap. involved and because final consumers are consumer also increase the chance that more susceptible to opportunism than fraudulent activity will thrive, as the
Eurohealth Vol 14 No 1 26 HEALTH POLICY DEVELOPMENTS example of the sale of counterfeit or low Box 1. Decision points and selected strategies quality drugs to patients in many countries demonstrates. WHO estimates that up to Manufacturing Establish and secure legal framework for Good Manufacturing Practice (GMP) for 25% of drugs consumed in developing local manufacturers in respective country and introduce appropriate fines for countries are counterfeit or sub-standard. industry for non-compliance with legal stipulations and quality standards and post Furthermore, corruption in this sector can publicly a list of compliant manufacturers. eventually have a negative effect on Retain a sufficient number of trained and well-paid inspectors and on a rotating national health budgets.12,13 Poor gover- schedule carry out regular random inspections to assure GMP compliance. nance in the pharmaceutical sector results Registration Establish transparent, effective and uniform laws and standards for drug regis- in the waste of scarce public resources tration to assure adequate drug quality control capacity. which reduces the ability of governments to provide access to high quality essential Publish drug registration information on the Internet and educate the public and medicines and this in turn increases the professionals to identify unregistered drugs. potential for unsafe medical products to Implement market surveillance and random batch testing. enter the market. Selection Define and publish clear criteria for selection and pricing based on international For example, an assessment of governance standards as established by the WHO. in Bulgaria’s pharmaceutical system found that the selection and procurement of Publish drug selection committee membership and meetings schedule and results pharmaceuticals was insufficiently trans- obtained/decisions made. parent and too vulnerable to conflicts of Procurement Assure transparent procurement procedures, written procedures and explicit criteria interest. There was little effective oversight for contract awards with strict adherence to announced closing dates. in the drug selection process and very limited public input. The study also found Monitor supplier selection and keep written records for all bids received; make evidence of attempts by some international adjudication available to all participating bidders and the public. and local drug producers to exert influence Report regularly on key procurement performance indicators. at almost every level of the system.8 Distribution Develop information systems to ensure drugs are allocated, transported, and stored In many transition economies, in appropriately. particular in South Eastern Europe, the rapid deregulation and decentralisation in Assure regular communication between every level of the system to control the pharmaceutical sector, combined with inventory and deliveries. unstable economic and political environ- Secure appropriate storage facilities and transport. ments created governance vulnerabilities in Establish electronic monitoring of stock in distribution and check delivery orders the health sector. In particular the against inventories of products delivered to identify theft. procurement practices were vulnerable to undue influence during drug selection, Develop and engage professional associations to improve adherence to profes- kickbacks or bribes that enabled bidders’ sional codes of conduct. to access confidential information and use Pharmaceutical Use information systems to monitor physician prescription patterns. of direct procurement instead of compet- prescribing 14 Impose penalties for breaches of legal and ethical standards. itive bidding. and dispensing Albania and Macedonia are among the Regulate industry interaction with prescribers through explicit criteria that limit countries in the region that have made industry gifts and payments and require physicians to post industry gifts. significant strides to introduce a more License and inspect pharmacies. transparent public procurement and inter- national tendering system. Azerbaijan Source: Adapted from17. Framework originally developed by USAID. advanced in modernising the central drug laboratory and retrained critical technical mental responsibility in the pharmaceutical Assessments and other means of sharing staff. Furthermore the country succeeded sector is two-fold; first, it involves regu- international evidence and best practice are in implementing regular batch testing of lation of the manufacturing, distribution, helpful in attaining this goal.16 Govern- drugs, introducing tamper proof packaging sale and use of pharmaceutical products. mental regulation of the pharmaceutical and establishing a hotline for consumers Second, it relates to selecting, purchasing, industry must balance the concern for the and drastically increased the seizure of and logistically managing drugs for use in health of the population on one hand with unregistered drugs on the market.15 public health care systems in those situa- the promotion of industrial and trade Good governance is key to ensuring a tions where governments are the primary policies to strengthen competitiveness, sound and well functioning pharmaceu- providers of drugs to the public. foster innovation and promote cost-effec- tiveness on the other hand.17 tical system that provides good access to Government involvement, especially essential medicines for the population of through regulation of pharmaceutical Soft spots in the pharmaceutical supply any country. Governments are obliged to policies on procurement, quality control, chain establish and maintain sound institutional pricing and prescribing, is crucial in order The pharmaceutical supply chain is structures and policies in order to ensure to maintain an efficient pharmaceutical different from other commodities in the the wellbeing of their citizens. Govern- sector. Tools such as Health Technology
27 Eurohealth Vol 14 No 1 HEALTH POLICY DEVELOPMENTS market as it is highly complex, technically challenging and fraught with market Box 2. Application of the WHO Pharmaceutical System Assessment Tool failures due to information asymmetry and hence more vulnerable to governance Assessment of Albania’s pharmaceutical system breakdowns and corruptions at every link The WHO Assessment Tool was recently used to conduct an assessment of Albania’s Pharmaceutical in the chain. Based on a framework origi- System. Most of the drugs in Albania are imported, with a smaller number produced locally. Drugs nally established by USAID, and further are procured by the public sector for use in hospitals and the private sector supplies drugs for adapted by Cohen et al18 the drug supply outpatient use. Payment for these pharmaceutical products is through the national health insurance chain can be broken down into manufac- fund as well as private out of pocket payments. turing, registration, selection for reim- The procurement, selection, registration, inspection and promotion activities of the system were bursement, procurement, warehousing and assessed through a series of quantitative and qualitative interviews and assigned points on a ten distribution and prescription/service delivery. Box 1 demonstrates key decision point rating scale ranging from zero (extremely vulnerable to corruption) to ten (minimally points and required minimum policies at vulnerable to corruption). The assessment produced the following results; procurement, registration, every link in the chain. inspection and promotion components of the system were rated as marginally vulnerable, inspection was rated moderately vulnerable, while the selection process was rated as very vulnerable to The potential for mismanagement and corruption. corruption exists at all these decision As a follow up to this, Albania is drafting a Health System Strategy (2007–2013), which highlights points unless there are strong institutional investments and capacity building for governance as a key priority area. Additionally, health, drug checks and balances maintained and over- and health financing laws are currently being revised sight mechanisms in place to prevent 21 abuse. In many transition economies Source: Forzley M, 2008. government officials often have a (near) monopoly on a number of these decision light areas where interventions can be pharmaceutical systems “through the points, which increase the system’s suscep- made. application of transparent, accountable tibility to mismanagement, fraud and administrative procedures and the corruption. For instance, government offi- Useful policy tools have been developed to promotion of ethical practices among cials are involved in determining the attempt to assess weak links within phar- health professionals”.12 selection of drugs for inclusion in national maceutical systems. One of these is the formularies, a process which can be marred Pharmaceutical Assessment Tool, first A three step approach has been identified by corrupt practices, since it is in the developed by Cohen et al19 and further in implementing this initiative and it interest of manufacturers (and often a enhanced and adapted by the WHO12 includes: significant economic windfall) to have which builds on early work done by Klit- (i) a national assessment of transparency their products included on essential drug gaard.* According to Klitgaard’s schematic and vulnerability to corruption, which lists. Weak institutional processes therefore equation, corruption [C] equals monopoly involves the use of a standardised can result in national formularies including [M] plus discretion [D] minus accounta- assessment instrument that builds on drugs that are not necessary or the most bility [A], resulting in: the tool described above; cost-effective.8 C = M + D – A (ii) the development of a national Governance initiatives and assessment This equation identifies key conditions programme on good governance for tools in the pharmaceutical sector that facilitate corruption in a system, medicines; and Given the negative consequences that including in a country’s pharmaceutical (iii) implementation of the programme corruption in the health sector, and in the system.20 The WHO assessment tool (see Box 2). pharmaceutical area in particular, can have utilises standardised questionnaires to on the lives of people, there is a strong case assess vulnerability at key decision points The programme is currently operational in for government regulation of this market. in the pharmaceutical system. A ten point ten countries and is expected to further Based on international evidence it is rating system which ranges from expand to other countries based on essential for governments to exercise ‘extremely vulnerable’ to ‘minimally requests from concerned governments.12 strong leadership and establish a vulnerable’ is used to assess a system’s Related to this, the WHO has also framework for the rule of law and good degree of vulnerability to corruption. This developed The Manual for Measuring governance practices as a key element to was first tested successfully in Costa Rica Transparency to Improve Good Gover- regulate the health and pharmaceutical and has since been used in a number of nance in the Public Pharmaceutical Sector, sector. An important first step is the iden- countries, including in some transition which details fifty-one indicators that can tification of market failures and the causes countries in Europe, such as in Albania be collected to monitor transparency and motivation underlying corrupt prac- (Box 2). under the areas of registration, promotion, tices, the people involved, as well as the inspection, selection, and procure- Since 2004, the World Health Organi- areas most susceptible to corruption.12,13,17 ment.12,13 In addition to this, the World zation (WHO) has undertaken the Good Measuring, documenting and communi- Bank has through projects and technical Governance for Medicines Program the cating instances of abuse, corruption and assistance worked with countries to goal of which is to reduce corruption in mismanagement is critical, as this can high- identify and address policy issues in their pharmaceutical sectors as well as improve their pharmaceutical procurement systems 22,23 * Robert Klitgaard did seminal work that defined corruption and its characteristics among other things.
Eurohealth Vol 14 No 1 28 HEALTH POLICY DEVELOPMENTS
Conclusion Available at: http://www.who.int/ Pharmaceuticals are a key input into health REFERENCES medicinedocs/fr/d/Jwhozip27e? care and cover a large, and for many coun- 1. Lewis M. Governance and Corruption in 12. World Health Organization. Good tries a growing share of the health budget. Public Health Care Systems. Washington Governance for Medicines. Geneva: World They are a high tech, high value input to DC: Centre for Global Development, Health Organization, 2007. Available at: achieve and maintain health outcomes for 2006, Working Paper 78. Available at: http://www.who.int/medicines/areas/ a population. In its extreme, access to http://www.cgdev.org/content/ policy/goodgovernance/GGM.pdf publications/detail/5967%20 drugs can mean the difference between life 13. U4 Anti-Corruption Resource Centre. and death in many circumstances, espe- 2. Transparency International. Global Corruption in the Health Sector. Bergen: cially for the poor and vulnerable popula- Corruption Report: Special Focus on U4, 2006. Available at: tions. As in the health sector in general, Corruption and Health. London: Pluto http://www.u4.no/themes/health/main.cfm pharmaceuticals are no exception to the Press, 2006. Available at: http://www.transparency.org/ 14. Neveleff DJ. Case Study: Challenges in issue of market failures due to information the Pharmaceutical Value Chain in asymmetry. As such, this sector requires publications/gcr/download_gcr/download _gcr_2006#download Bastania. Washington DC: World Bank, strong and effective regulation and gover- 2007. nance practices in order to avoid misman- 3. World Bank. Strengthening World Bank 15. World Bank. Azerbaijan Health Sector agement and opportunities for corruption Group Engagement on Governance and Review Note. Washington DC: World and to ultimately minimise the occurrence Anticorruption. Washington DC: World Bank, 2007. Available at: Bank, 2005. Available at: of adverse outcomes for the consumers of http://go.worldbank.org/BZ6XNMSFP0 drug products. http://www.worldbank.org/html/extdr/ comments/governancefeedback/ 16. Mrazek M, Fidler A. Access to Europe’s transition countries and devel- gacpaper-03212007.pdf pharmaceuticals and regulation in the oping countries in general often lack a 4. World Bank. Overview of Anticor- Commonwealth of Independent States. In: sufficient legal and regulatory framework ruption. Washington DC: World Bank, Mossialos E, Mrazek M, Walley T (eds) in the health sector and are oftentimes just 2007. Available at: Regulating Pharmaceuticals in Europe: in the process of establishing the rule of http://go.worldbank.org/K6AEEPROC0 Striving for Efficiency, Equity and Quality. law in public policy. Similarly, professional Buckingham: Open University Press, 2005. 5. Kaufmann D, Kraay A, Mastruzzi M. associations have only begun to establish Governance Matters VI: Governance 17. Cohen JC, Mrazek M, Hawkins L. codes of conduct and standards for their Indicators for 1996–2006. Washington DC: Tackling corruption in the pharmaceutical members and are only starting to attempt World Bank, 2007. Available at: systems worldwide with courage and to enforce self regulation for transgressors http://info.worldbank.org/governance/ conviction. Clinical Pharmacology and among their membership. wgi2007/home.htm Therapeutics 2007;81(3):445–49. In order to achieve a coherent evidence 6. Campos J E, Bhargava V. Tackling a 18. Cohen JC, Mrazek MF, Hawkins L. and rules based system for pharmaceutical social pandemic. In: Campos J E, Pradhan Corruption and pharmaceuticals: Strength- governance, it has been shown to be S (eds) The Many Faces of Corruption: ening good governance to improve access. important to ensure intergovernmental Tracking Vulnerabilities at the Sector In: Campos J E, Pradhan S (eds) The Many Faces of Corruption: Tracking Vulnerabil- collaboration, (health, law enforcement, Level. Washington DC: World Bank, 2007. ities at the Sector Level. Washington DC: customs, judiciary, etc). Additionally, the 7. Cohen JC. Pharmaceuticals and World Bank, 2007. consumer increasingly also has an corruption: a risk assessment. In: Kotalik J, important role to play. As consumers are Rodriguez D (eds) Transparency 19. Cohen JC, Cercone J, Macaya R. getting better informed, they will demand International’s Global Corruption Report. Improving Transparency in the Pharmaceu- greater transparency in pharmaceutical London: Pluto Press; 2006. tical System: The Case of Costa Rica. Washington DC: World Bank, 2002 systems and from their service providers. 8. Meagher P, Azfar O, Rutherford D. Evidence has shown that increasing Governance in Bulgaria’s Pharmaceutical 21. Forzley M. Governance and the consumer awareness can result in System: A Synthesis of Research Findings. Combat of Corruption in the Pharmaceu- achieving support for particular challenges College Park: IRIS Centre, 2005. Available tical Sector. Presentation to World Bank, such as the control of counterfeit drugs etc. at: http://pdf.usaid.gov/pdf_docs/ March 12 2008. Available at http://michel PNADF523.pdf forzley.com/pdf/WorldBankHealth- Governments, in addition to establishing Sector3_12_08handout.pdf the legal and regulatory framework 9. World Health Organization. WHO 20. Johnston M. Unpredictable Rules, described above should also get involved Medicines Strategy: Countries at the Core. Geneva: World Health Organization, 2004. Dishonest Competition and Corruption: in monitoring their pharmaceutical Costs for Development and Good Gover- systems performance through interna- Available at: http://whqlibdoc.who.int/hq/ 2004/WHO_EDM_2004.5.pdf nance. Washington DC: World Bank, 1999. tional benchmarking and promote Available at: http://info.worldbank.org/ accountability of the respective stake- 10. European Bank for Reconstruction and etools/docs/library/108380/session4f.pdf holders involved. Finally, professional Development. Life in Transition: A Survey 22. Govindaraj R, Reich MR, Cohen JC. organisations, particularly in transition of People’s Experiences and Attitudes. London: EBRD, 2007. Available at: World Bank Pharmaceuticals. Washington countries, should be supported but also be DC: World Bank, 2000. held accountable for implementation of http://www.ebrd.com/pubs/econo/lits.pdf policies and professional guidelines that 11. World Health Organization. Public- 23. Imasheva A, Seiter A. The Pharmaceu- promote ethical behaviour of their Private Roles in the Pharmaceutical Sector: tical Sector of the Western Balkan Countries. Washington DC: World Bank, members. Implications for Equitable Access and Rational Drug Use. Geneva: WHO; 1997. 2008.
29 Eurohealth Vol 14 No 1 HEALTH POLICY DEVELOPMENTS Pharmaceutical policy challenges in Central and Eastern Europe
Andreas Seiter
Summary: Most of the transition countries in Central and Eastern Europe are under cost pressure from run-away pharmaceutical expenditure. Some of the factors leading to increased drug consumption are inevitable, while others could be contained with appropriate policy measures. Commercial interests of well resourced market participants give them an advantage in blocking or defusing attempts to control drug expenditure. Implementing cost containment measures successfully will require political backing from the most senior political level, a significant effort to increase human and technical capacity and partnerships between countries to address more complex scientific questions.
Keywords: transition countries; pharmaceutical expenditure; cost containment
Economic transition creates pressure to make ends meet with budgets that pharmacists and indirectly (as direct-to- from consumers and providers represent, on a per capita basis, only a consumer advertising is illegal in Europe) During the last two decades, the former fraction of the funds available to Western also to patients. As Figure 1 illustrates, the socialist countries in Central and Eastern European countries. resources at the disposal for industry are Europe have gone through a partially enormous. The worldwide sales of just two turbulent political and economic tran- Several factors contribute to run-away multinational pharmaceutical companies sition. In most of these countries, a pharmaceutical expenditure alone are greater than the entire economy ‘Western’ model of a free market society Patient demand for more sophisticated of Bulgaria and combined they are nearly with democratic rule has been more or less (and expensive) medicines is triggered by as big as the Hungarian economy.1 solidly established. In parallel, rapid self-education via the internet and through While it is easy to blame manufacturers economic growth has created a significant peer-to-peer networks. On the supply and providers for stimulating over- middle class of citizens who feel side, there is a sophisticated industry that prescribing and unnecessary use of ‘European’ and adopt a lifestyle similar to markets products to regulators, clinical expensive drugs despite cheaper alterna- their peers in Western Europe. At least in experts, specialists, family physicians, urban areas, one can see the same brands of cars, fashion, cosmetics and other Figure 1 : Comparison of incomes of two European countries and two multi-national lifestyle products as for example in pharmaceutical companies German, Dutch, French and Italian cities. When it comes to health care, it is easy to Gross National Income or Sales understand that citizens of transition US$ Billions countries also look towards their wealthier 100 brothers and sisters in the West to determine the aspired standard. They 80 demand access to the same level of diag- nosis and care and, in particular, the same 60 quality of medicines as available in the ‘old’ EU countries – drugs are ‘tangible’ 40 and therefore become a proxy for health care quality. This ‘sense of entitlement’ poses a challenge for politicians, who have 20
0 Bulgaria Company Company Hungary Andreas Seiter is Senior Health Specialist, A B The World Bank, Washington DC, USA. Email: [email protected] Source: World Bank, 20081 and Annual Reports 2006 for pharmaceutical companies A and B
Eurohealth Vol 14 No 1 30 HEALTH POLICY DEVELOPMENTS tives being available, it is hard to argue – Collusion between doctors and phar- measures have only temporary effects. against some other factors that contribute macists to charge insurance funds for This is due to provider adaptation (for to growing drug bills: drugs that are not dispensed – the example doctors prescribing more antibi- proceeds being split between the otics when simple cough and cold medi- – Some innovative medicines are in fact partners in the collusion. cines were removed from the life-saving, creating an ethical pressure reimbursement list) and a multi-factori- on health insurance systems to include By definition, the impacts of such practices ality of effects – making it difficult to them into their reimbursement lists are very hard to assess, as they go measure the impact of single interventions. unrecorded and the actors are rarely iden- – In the generic drug market (dominant This means that pharmaceutical cost tified or brought to justice in countries in most of the Central and Eastern containment is an ongoing effort. with limited law enforcement capacity. But European countries and served mostly on some occasions there is anecdotal While regulatory agencies, insurance funds by domestic manufacturers) upgrades evidence that the financial losses can be and ministries in developed countries to quality standards to comply with significant. One example is Montenegro, employ dozens or hundreds of well- Good Manufacturing Practices lead to where the introduction of a system for trained specialists equipped with modern higher manufacturing costs, which can tracking the prescribing and dispensing of equipment, many of the smaller young have an impact on retail prices medicines paid for itself within very short states in Eastern Europe have much more – Improved primary health care services time - prescribers changed their behaviour limited resources. Government officials are lead to higher utilisation of facilities and when they became aware that their actions not trained in modern management the discovery of more chronic pre- would become transparent, leading to cost methods; they frequently operate without existing conditions such as diabetes, savings of about 20% from baseline. standard operating protocols (SOPs) or high blood pressure or chronic- clearly defined decision making rules. obstructive lung disease. Practically Coping strategies Salaries in the public sector do not keep up each newly discovered case leads to Different countries in the region employ with free market salaries, leading to skills incremental drug spending – even if the different strategies to cope with the chal- erosion in the public sector workforce. most rational form of treatment is used lenge of run-away expenditure. Some stick Parliaments, under the influence of well to rigid budgets and force providers to funded lobbying groups and external – Ageing societies and the prevalence of apply rationing tactics – in the end this advisors, create complicated laws that unhealthy lifestyle habits create an means that patients may not get the medi- frequently are not assessed for their prac- increasing pool of chronically ill people cines they need from public sources and ticality, leaving the administration alone to have to pay out of pocket (if they can work out how to apply the law. This Corruption and mismanagement afford it).One example of strict budget creates a backlog in decision making. As a consequence of these factors, the enforcement is Poland, which has tried to Overall, what has been ongoing for a while overall drug bill is likely to grow faster mitigate the impact by providing certain in several countries is a painful trial-and- than national income can even under expensive but clinically important drugs error strategy that has the potential to optimal management. In reality, through special treatment programmes further undermine the standing of public management systems are under-developed outside the health insurance system. health insurance funds and weaken the and governance in public sector institu- perception of their managers in the eyes of tions is weak. In addition to the imbalance Other governments are more permissive private sector counterparts. of resources between private sector and give in to pressure from patients and providers and the public sector that is in providers, covering drug budget deficits at Leadership, simplicity, and technology as charge of controlling costs, there is signif- the end of every year from the general key ingredients for reform icant potential for leakage and inefficiency budget. One of example of this is Given the significant profits at stake, if due to corruption.2 This might take Romania, which shows several high priced private sector providers are unlikely to various forms, such as: drugs for rare indications on the top ten support proposals from administrators to list of drugs paid for by health insurance. – Inappropriate inducements to decision limit their entrepreneurial freedom for the Nevertheless, all countries try to makers and prescribers in form of cash, benefit of public health budgets and implement some cost containment travel, gift cards, free use of cars, schol- outcomes. Organised provider resistance measures, targeting parameters such as arships, consulting contracts for can only be overcome by strong and drug prices, reimbursement lists, reim- spouses and relatives. fearless political leadership. Unfortunately bursement levels, patient co-payments and such leadership is difficult to mobilise; – Free goods for wholesalers and retailers prescription volumes. sometimes it materialises after an obvious to crowd out competitors in the distri- The problem with these measures is that and massive failure in the system that bution chain. they require a range of skills and capacities creates near-bankruptcy of the public – Manipulation of invoices at customs to in order to be successful, such as a sound payer or public outrage over performance increase margins or reduce taxes and legal basis, political will, enforcement problems such as drug shortages. These tariffs. capacity, management skills and systems to windows of opportunity need to be used collect data for measuring both the – Collusion between bidders in public to make sensible adjustments in the distri- baseline and impact of a given measure. It procurement. bution of power and clean up decision has been shown repeatedly in rich coun- making processes. – Manipulation of data submitted for tries (generally facing the same issues of Simplicity should be the guiding principle price regulation. run-away drug expenditure although on a for all laws and by-laws. If laws contain higher level) that many cost containment
31 Eurohealth Vol 14 No 1 HEALTH POLICY DEVELOPMENTS too many technical specifications, the 1. Protecting the decision makers against regional partnerships. This could lead to a administration may get stuck with outside pressures, which are easier to single institution funded by several coun- outdated ways of doing things while the resist if decision criteria are clear. tries, or a network of specialised institu- market has moved on and adjusted, as any tions of smaller scale, which share 2. Protecting those who depend on the change in the law requires a parliamentary methodology and results and recognise decisions from reviewer bias and incon- hearing and vote. This is relevant for each others work. In the longer term, there sistent application of vague rules. example for pricing regulations, which may even be a European solution that may need to be modified in regular could benefit smaller countries by Cross-country partnerships for more intervals in response to counter-moves providing an authoritative opinion on the complex tasks deployed by providers. cost-effectiveness of new drugs similar to Some aspects of decision making on phar- the regulatory opinion provided by the By-laws that are written under the maceuticals are highly complicated from European Medicines Agency (EMEA). influence of external consultants, using the scientific, technical and process models from more developed countries, perspective. A key example is the decision Cost-effectiveness data cannot be easily sometimes turn out to be very challenging on the inclusion of new drugs into a reim- transferred from country to country, if the to implement by small, relatively bursement list, based on evaluation of underlying costs in the system are powerless administrations with limited costs and benefits versus available alterna- different. Some national capacity to technical capacity. Less is more in this case tives and against the reality of finite interpret and potentially recalculate results – for example a simple formula to limit the budgets. This decision is critical for the from another country is therefore price of generic drugs based on the last manufacturer of a new drug as it provides required. Again, a simple rules-based price of the original version minus a certain access to financing; manufacturers usually approach like a scoring system that quan- percentage is easy to calculate and trans- spend big money to present a convincing tifies expert perceptions in the absence of parent. A sophisticated external reference dossier and win over members of expert exact data is preferable over an academic price system, as it is currently employed in committees, who routinely are consulted approach that tries to achieve exact some countries, may lead to data overload in these decisions. outcomes but is vulnerable due to lack of and interpretation problems that slow data or fights over the methodology. In developed countries, specialised institu- down decisions or open the door for costly tions set up as independent scientific and time consuming appeals procedures bodies play the role of providing neutral and lawsuits. REFERENCES assessment (the best known example is the The available technical and managerial National Institute for Health and Clinical 1. World Bank. World Bank Country expertise should be focused on drafting Excellence, NICE, in England and Wales). Database. Washington DC: World Bank, 2008. specific implementation rules and proce- For many countries, setting up such an dures (SOPs) at the administrative level, institution is beyond their financial and 2. Based on interviews with stakeholders which have two main functions: human resources. A potential solution to conducted by the author in various address this problem would be to develop countries.
Health Economics, Policy and Law
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Eurohealth Vol 14 No 1 32 Evidence-based health care
Moderate activity reduces diabetes risk
Hands up everyone who knows what a MET is? Systematic review Answer is a Metabolic Equivalent Task, which is the The review sought observational studies up to amount of energy expended in performing various March 2006 associating moderate exercise with inci- activities compared with sitting down doing dence and prevalence of type 2 diabetes. Moderate nothing. It is commonly used in medicine to express intensity exercise was that with a MET score of 3–6. metabolic rates measured during a treadmill test. Two definitions of the MET are used, essentially Results equivalent: Ten cohorts were found with just over 300,000 persons of both sexes aged mostly between their One MET is equivalent to a metabolic rate late-30s to early-60s. Follow up in these studies consuming 3.5 millilitres of oxygen per kilo- tended to be long with seven of the studies longer gramme of body weight per minute. than seven years, and the shortest four years. The One MET is equivalent to a metabolic rate mean follow up period, weighted by study consuming 1 kilocalorie per kilogramme of body numbers, was 8.2 years. weight per hour. In most of the studies exercise included walking, In more common parlance, a slow walk or prom- but cycling and light gardening were also included. enade is equivalent to about two METs, a brisk walk The definition of diabetes varied, including glucose about four METs, and gym work more like six tolerance test results, the use of primary care or METs and above. A new systematic review of national registers, and, mostly, by self-report of a observational studies links moderate periods of diagnosis by a physician, usually validated. moderate intensity exercise with reduced risk of There were 9,400 cases of diabetes, a prevalence of developing type 2 diabetes in adults.1 3.1%. This meant that type 2 diabetes occurred in 0.4% of these older adults every year, a risk of 1 in 263 per year. Compared with sedentary persons, the Table 1: Evidence associating physical activity and walking with reduction in risk of developing type-2 diabetes risk was substantially lower in people who took moderate exercise (by about 30%), whether all Percent risk activity or only brisk walking was used in the tests Observation Studies People Relative risk reduction of association (Table 1). Because people who take no exercise tend to be fatter, there was adjustment of Total physical activity risk for BMI, and here the reduction of risk was about 17%. Development of type 2 diabetes, 9 213,314 0.69 (0.58 to 0.83) 31 no BMI adjustment Comment The amount of exercise examined in this paper was Development of type 2 diabetes, 9 295,231 0.83 (0.76 to 0.90) 17 with BMI adjustment not heroic, amounting to no more than about 2.5 hours of brisk walking every week. The message is Walking that to help avoid developing diabetes, you don't necessarily have to go into the gym, just walk down Development of type 2 diabetes, there and then walk back again. Given that walking 4 152,698 0.70 (0.58 to 0.84) 30 no BMI adjustment does other good things positively affecting the heart, circulation, bone, balance and weight, this is Development of type 2 diabetes, something of a no-brainer. Diabetes is worth 4 234,615 0.83 (0.75 to 0.91) 17 with BMI adjustment avoiding.
REFERENCES Bandolier is an online journal about evidence-based healthcare, written by 1. Jeon CY, Lokken RP, Hu FB, van Dam RM. Oxford scientists. Articles can be accessed at www.jr2.ox.ac.uk/bandolier Physical activity of moderate intensity and risk of type 2 diabetes. Diabetes Care 2007;30:744–52. This paper was first published in 2007. © Bandolier, 2007.
33 Eurohealth Vol 14 No 1 Risk in Perspective
VALUING “LIVES SAVED” VS. “LIFE-YEARS SAVED”
James K Hammitt
Introduction viduals. The extent to which VSL and There is long-standing debate whether to VSLY vary with life expectancy, age, health, count ‘lives saved’ or ‘life-years saved’ and other factors is not clear; better when evaluating policies to reduce empirical evidence is required. mortality risk. Historically, the two approaches have been applied in different Key concepts “Theory and empirical domains. Environmental and trans- Describing environmental, health, and portation policies have often been eval- safety interventions as ‘saving lives’ or evidence suggest that uated using lives saved, while life-years ‘saving life-years’ can be misleading. saved has been the preferred metric in other Reduction in exposure to a hazard typically neither VSL nor VSLY areas of public health including medicine, reduces some people’s chances of dying is constant over an vaccination, and disease screening. For from that hazard by a small amount, benefit-cost analysis, the monetary value of thereby ‘saving lives’ (at least from that individual’s life. Accurate risk reductions can be calculated either by hazard). Reducing the risk of dying now valuation requires using multiplying expected lives saved by the increases the risk of dying later, so these ‘value per statistical life’ (VSL) or by multi- lives are not saved forever but life-years are values that depend on plying expected life-years saved by the gained. It is usually impossible to know ‘value per statistical life-year’ (VSLY). either beforehand or afterward whose characteristics of the death will be or was averted, so the lives or The choice between metrics can affect the life-years that are saved are anonymous. affected individuals.” apparent merits of regulatory programmes that affect people with different life Value per Statistical Life (VSL) expectancies. For example, the air pollution An individual’s value per statistical life measures that dominate the US regulatory (VSL) is defined as her rate of trade-off agenda may disproportionately benefit between wealth and small changes in people who are older or in poor health and mortality risk in a defined time period. For have shorter-than-average life expectancies. example, if a typical individual is willing to The benefits of these rules may appear pay at most $5 to reduce her chance of larger when counting lives rather than life- dying this year by 1 in a million, her VSL is years saved. Conversely, policies to protect $5 ÷ (1 in a million) or $5 million. The term children such as car-seat requirements may ‘value per statistical life’ can be understood appear to be larger when counting life- by recognising that if each of 1 million years saved. The US Office of Management people were willing to pay $5 to reduce his and Budget has encouraged federal agencies or her chance of dying this year by 1 in a This article is reproduced with to analyse regulations using both the lives- million, a total of $5 million dollars would permission and was first published as saved and life-years-saved approaches. be pledged and one fewer death would be Risk in Perspective Volume 16, Number 1 expected. by the Harvard Center for Risk Analysis This Risk in Perspective article describes how the value of any intervention that in March 2008. VSL is defined for very small changes in alters mortality risk can be expressed using risk. Theoretically, an individual’s VSL is either lives saved or life-years saved and the Harvard Center for Risk Analysis, the slope of an indifference curve repre- appropriate VSL or VSLY. However, Harvard School of Public Health, senting her preferences for wealth and because theory and empirical evidence Landmark Center, 401 Park Drive, survival probability. As illustrated in Figure suggest that neither VSL nor VSLY is PO Box 15677, Boston, 1, an individual’s rate of trade-off between constant over an individual’s life, accurate Massachusetts, 02215 USA. wealth and risk will depend on the size of valuation requires using values that depend The full series is available at the risk change. A typical person who www.hcra.harvard.edu on characteristics of the affected indi-
Eurohealth Vol 14 No 1 34 EVIDENCE-INFORMED DECISION MAKING
Figure 1: Value per statistical life (VSL) is equal to the slope of the individual’s indifference curve at Survival curves her wealth and survival probability, i.e., WTP/dp for a small increase in survival probability and WTA/dp for a small decrease in survival probability. As the risk change dp increases, willingness Changes in mortality risk are most accu- to pay (WTP) increases less than proportionately to dp and willingness to accept (WTA) increases rately described using survival curves. more than proportionately to dp. Survival curves can be constructed for an individual or a population. An individual survival curve plots the probability that an individual will remain alive as a function of age (or calendar date). A population Indifference curve survival curve plots the fraction of a popu- lation that remains living as a function of
lth age or date. A survival curve can be constructed beginning at any age or date. Wea The height of the curve begins at one and declines as age and time increase. The slope of the curve depends on the mortality risk, with steeper decreases in periods of higher mortality risk. VSL WTA dp WTP dp The survival curve for the US population beginning at age 60 is illustrated by the solid line in Figure 2. Life expectancy at any age is the area under the survival curve 0 Survival (= 1 - risk) 1 that begins at that age. For the solid curve, life expectancy at age 60 is 22 years. Any pattern of change in mortality risk Figure 2: Survival curves from age 60. Solid line is for the US population. Dashed line corresponds over time can be described by the corre- to decreasing mortality risk at each age from 71 to 80 by one third. sponding shift in the survival curve. Moreover, any change in a survival curve implies a unique expected number of life- 1.00 years saved (the change in the area under the curve) and a unique expected number of lives saved at each point in time (the 0.75 vertical shift in the curve at that time). The total number of lives saved during a time period (which may include saving the same 0.50 life multiple times) depends on the period examined; for periods much longer than a century or so, the number of lives saved Surviva l p robability 0.25 (among a cohort) must be zero. Note that there is no unique change in the survival curve corresponding to a specified number of life-years saved or to a specified number 0 60 70 80 90 100 of lives saved in a time period. The survival Age curve and how it shifts are the fundamental concepts; the numbers of life-years saved and lives saved in a specified time period would pay $5 to reduce her chance of it by only days (even if those days are are alternative and partial summary dying this year by 1 in a million could not precious). The VSLY approach values a measures of the shift. afford to pay $1 million to reduce her reduction in mortality risk in proportion chance of dying this year by one in five to the gain in life expectancy. Under this To illustrate, consider an intervention that (for example, from 21% to 1%). Similarly, approach, reducing an individual’s risk of decreases annual mortality probability by she would not accept certain death this dying in the current year produces a gain one-third, persists for ten years, and begins year in exchange for $5 million. (As illus- equal to the increase in the chance of after a ten year lag. The dashed line in trated in Figure 1, she might not accept surviving the year multiplied by her life Figure 2 illustrates the effect of this inter- certain death in exchange for any amount expectancy conditional on survival. The vention for the average 60 year old. There of wealth.) value of this gain is equal to the expected is no change in survival probability during number of life-years saved multiplied by the lag period (ages 60 to 69). The survival Value per Statistical Life-Year (VSLY) the VSLY. (Future life-years are usually curve is flatter over the period during It seems intuitive that the value to an indi- discounted and the value of reducing the which risk is reduced (ages 70 to 79) and vidual of delaying her death depends on risk of dying this year is proportional to remains higher than the baseline survival the duration of the delay. Postponing death the expected present value of future life- curve for later years (ages 80 and above). by years is usually preferred to postponing years.) For each 60 year old affected, this inter-
35 Eurohealth Vol 14 No 1 EVIDENCE-INFORMED DECISION MAKING vention saves one life-year and 0.08 lives Empirical estimates are derived using the number of deaths each day provide (between ages 70 and 79). either ‘revealed-preference’ or ‘stated-pref- estimates of the number of lives that may erence’ methods. Revealed-preference be saved by reducing pollution, but not the Valuing reductions in mortality risk studies are based on observation of behav- number of life-years. The problem is the Each person’s willingness to pay (WTP) iours that affect mortality risk and wealth. difficulty in knowing whether the people for a specified shift in her survival curve The most common are wage-differential who succumb to these hazards have the can be estimated by dividing the shift into studies that estimate the extra pay workers same life expectancy as others of their age a series of instantaneous changes in risk receive for more hazardous jobs. In and sex or are more susceptible to these (or and summing her WTP for each of these contrast, stated-preference studies ask other) risks. ‘blips’.1 WTP for each blip depends on the survey respondents about hypothetical In contrast, cohort studies that monitor size of the risk reduction, time of payment, choices. Many of these ask about choices populations exposed to different levels of conditions under which the individual can between safer but more expensive food or pollution (for example, those living in save and borrow against future income, transportation or about hypothetical medi- different cities) provide estimates of the and other factors. cines or disease-screening programmes. survival curve and how it depends on WTP for a shift in the survival curve can Recent wage-differential studies that pollution. These studies can be used to be described using either VSLY or VSL. examine how VSL varies with age support estimate the number of life-years saved but The individual’s average VSLY for a shift the inverted-U hypothesis.2 These studies not the number of lives saved. The same is her WTP for the shift divided by the are limited in that they necessarily include shift in the population survival curve can expected number of life-years saved. Her only employed workers and thereby be the result of extending the lives of many average VSL for a shift is her WTP divided exclude the elderly and those in poor people for a short time or the lives of fewer by the expected number of lives saved in a health. Stated-preference studies, which people for a longer time.4 To illustrate, specified time period. If an individual is can include a broader population, yield consider a stylised example: In a ‘polluted’ willing to pay at most $80,000 for the (very mixed results. Some suggest little or no city, half the population dies at age 60 and large) shift in the survival curve illustrated effect of age on VSL and others suggest a the other half at age 70. In a ‘clean’ city, in Figure 2, her average VSLY for this shift modest decrease at older ages.3 half the population dies at 70 and the other is $80,000 (= $80,000 ÷ 1 life-year saved) half at 80. Living in the clean city is asso- It is not possible for both VSL and VSLY and her average VSL is $1 million (= ciated with an increase of ten statistical life- to remain constant over the lifecycle since $80,000 ÷ 0.08 lives saved). years per capita. However, it is impossible life expectancy changes with age. The to determine from the survival curves Estimating WTP to reduce mortality risk empirical evidence suggests that neither alone whether the difference arises because VSLY nor VSL is constant over the Average VSL and average VSLY for a shift everyone in the clean city lives ten years lifespan. If VSL follows an inverted U, in a survival curve may depend on the longer than they would in the dirty city, or then VSLY must increase at young ages initial survival curve, the details of the because the people who die at 60 in the when VSL is increasing and life expectancy shift, and other factors. Economic theory dirty city would have lived to 80 in the is decreasing. VSLY could be roughly does not predict that either VSL or VSLY clean city. In the first case, the number of constant at older ages if the rate at which will be constant across interventions or lives saved (at ages 60 and 70) is equal to VSL decreases coincides with the rate at individuals. In theory, both VSL and VSLY the population; in the second, it is equal to which life expectancy decreases. Some may change with age, life expectancy, half the population. wage-differential studies suggest VSL anticipated future health, income, and declines more rapidly than life expectancy, For risks associated with exposure to other factors. which implies that VSLY decreases with chemicals that may cause cancer or other Most studies of WTP to reduce mortality age.2 If VSL is roughly constant with age disease, epidemiological data may not exist risk estimate the value of a reduction in or decreases only modestly at older ages, and risk estimates are often based on current risk, i.e., VSL. These studies do not as the stated-preference studies seem to studies of laboratory animals. In these provide information on how VSL varies suggest,3 then VSLY increases over the cases, estimation of either lives saved or with life expectancy per se, but some lifespan. life-years saved requires strong assump- provide information on how it varies with tions about how to extrapolate from effects age. Although it seems intuitive that WTP Estimating lives saved and life-years observed in highly exposed laboratory to reduce current risk decreases with age, saved animals to effects in less highly exposed as the number of future life-years at stake In practice, it may be more difficult to humans, including the type of cancer or declines, VSL may remain constant or even estimate the effect of an intervention on other disease, the probability of lethality, increase with age. One reason is that either lives or life-years saved. For the latency of the disease, and the life income and wealth usually rise with age, at mortality risks where victims are identi- expectancy of the affected population. least over part of the lifecycle. Higher fiable ex post, such as motor-vehicle income and wealth increase ability to pay crashes and deaths from a signature disease Conclusion and hence increase VSL. In addition, as life (for example, mesothelioma from asbestos The effects of environmental, health, and expectancy declines an individual may exposure), the number of lives saved can safety interventions on mortality risk are have less reason to conserve her wealth for be estimated but the number of life-years most accurately characterised as shifts of future needs. Some economic models saved cannot without information about individuals’ survival curves. The monetary suggest that VSL follows an inverted U, the life expectancy of the affected popu- value to an individual of a change in her rising through middle age and falling at lation. Similarly, time-series studies that survival curve depends on the magnitude older ages. analyse how daily air pollution levels affect and timing of changes in her mortality risk.
Eurohealth Vol 14 No 1 36 EVIDENCE-INFORMED DECISION MAKING
Any shift in a survival curve implies expected numbers of both life-years gained New publications from and lives saved in a specified time period. the European Observatory on Health Hence the value of the shift can be described by the corresponding average Systems and Policies value per life-year saved (VSLY) or value per life saved (VSL); the choice between these measures is arbitrary. Pharmaceutical policies in Finland. Challenges and opportunities Note that an individual may assign different monetary values to alternative Health systems are under continuous pressure to meet the changes in her survival curve, even if they demands of their populations. In Finland, one area currently produce the same number of life-years under review is that of pharmaceutical policy. Following a saved or the same number of lives saved in request made by the Health Department, Ministry of Health and a specified time period, resulting in Social Affairs, this new report, by the Observatory, provides a different average VSL and VSLY. policy review of the regulatory system of pharmaceutical policies in Finland. Accurately valuing changes in mortality risk requires using values that are appro- The assessment by authors Elias Mossialos and Divya Srivastava priate to the risk change, which may suggests that despite the challenges within a very developed system of pharmaceutical depend on the age, health, life expectancy, regulation, there are practical options: and other characteristics of the affected − to improve transparency and pricing policies population. The existing empirical liter- ature offers conflicting evidence about − to strengthen the institutional environment how VSL and VSLY change with age; − to improve the development of pharmacotherapy practices. better empirical evidence is needed. The purpose of the report is not to provide prescriptive solutions but to suggest a range Note: This essay is adapted from Hammitt, of options for policy-makers to reflect on so as to assist them in the process of policy 5 2007 ; Peer reviewer: Henrik Andersson. review. The report offers a range of views from an international perspective and it is intended that this study might stimulate further debate on the continuing development of pharmaceutical policies. REFERENCES Available for free download at http://www.euro.who.int/Document/E91239.pdf 1. Johannesson M, Johansson P-O, Lofgren KG. On the value of changes in life expectancy: blips versus parametric changes. Journal of Risk and Uncertainty Ensuring value for money in health care. The role of health 1997;15:221–39. technology assessment in the European Union 2. Aldy JE, Viscusi WK. Age differences in This new book from the Observatory provides a detailed review the value of statistical life: revealed pref- of the role of health technology assessment (HTA) in the erence evidence. Review of Environmental European Union. It examines related methodological and process Economics and Policy 2007;1:241–60. issues in the prioritisation and financing of modern health care, 3. Krupnick A. The senior death discount and presents extensive case studies on the situation in Sweden, the and stated preference evidence. Review of Netherlands, Finland, France, Germany and the United Environmental Economics and Policy Kingdom. 2007;1:261–82. Written by Corinna Sorenson, Michael Drummond and Panos 4. Rabl A. Interpretation of air pollution Kanavos, the book aims to highlight ways in which the HTA process in Europe could mortality: number of deaths or years of life be improved by examining key challenges and identifying potential opportunities to lost? Journal of the Air and Waste support value and innovation in health care. A number of issues are examined and there Management Association 2003;53:41–50. is a particular emphasis on the responsibility and membership of HTA bodies, 5. Hammitt JK. Valuing changes in assessment procedures and methods, the application of HTA evidence to decision- mortality risk: lives saved versus life years making, and the dissemination and implementation of findings. saved. Review of Environmental Economics and Policy 2007;1:228–40. The authors observe that overall, “HTA can play a valuable role in health care decision- making, but the process must be transparent, timely, relevant, in-depth and usable. Assessments need to use robust methods and be supplemented by other important FURTHER READING criteria. Maximisation of HTA will enhance potential decision-makers’ ability to Hammitt JK. Valuing mortality risk: implement decisions that capture the benefits of new technologies, overcome uncer- theory and practice. Environmental Science tainties and recognise the value of innovation, all within the constraints of overall health and Technology 2000;34:1396–1400. system resources.” Robinson LA. How US government Available for free download at http://www.euro.who.int/document/E91271.pdf agencies value mortality risk reductions. Review of Environmental Economics and Policy 2007;1:283–99. Also, visit the Observatory web site at http://www.euro.who.int/observatory
37 Eurohealth Vol 14 No 1 NEW PUBLICATIONS
Eurohealth aims to provide information on new publications that may be of interest to readers. Contact Sherry Merkur at [email protected] if you wish to submit a publication for potential inclusion in a future issue.
Dame Carol Black's Review of the health Based on the fact that improving the managed, multidisciplinary approach, of Britain's working age population health of the working age population is called Fit for Work, which would aim to crucial to securing both higher economic provide treatment, advice and guidance growth and increasing social justice, this for people in the early stages of sickness review seeks to establish the foundations absence. Furthermore, she calls for for a new vision for health and work in specialist mental health provision to be Britain. The vision has three principal fully integrated in government objectives: prevention of illness and employment support programmes. promotion of health and well-being; In summary, Dame Black recommends early intervention for health conditions; an expanded role for occupational health, and an improvement in the health of placing it within a broader collaborative those out of work. and multidisciplinary service. This The review sets a baseline by detailing service should be available to all, and assessing the health of the working including those entering work, seeking to London: The Stationery Office, age population. It was found that stay in work, or trying to return to work March 2008 common mental health problems and following illness or injury. ISBN 978 0 11 702513 4 musculoskeletal disorders are the major Contents: Foreword; Executive causes of sickness absence and 125 pages summary; Key Challenges and Recom- worklessness due to ill-health. mendations; Introduction; The Health of Freely available on line at: Furthermore, the annual economic costs the Working Age Population; The Role http://www.workingforhealth.gov.uk/Carol- of sickness absence and worklessness of the Workplace in Health and Well- Blacks-Review associated with ill-health are estimated being; Changing Perceptions of Fitness to be over £100 billion. for Work; Developing a New Model for Thus, Dame Black calls for a shift in atti- Early Intervention; Helping Workless tudes to ensure that employers and People; Developing Professional employees recognise the key role that the Expertise for Working Age Health; The workplace can play in promoting health Next Generation; Taking the Agenda and well-being. She proposes a case- Forward; Appendix – Glossary.
Health Technology Assessment on the Net The purpose of Health Technology research sources. Assessment (HTA) is to provide health This guide provides resources available in care decision-makers with the evidence Prepared by: L Chan, S Collins, English, with an emphasis on those from they need to help make informed deci- L Dennett, and J Varney Canadian, UK and American sources. sions concerning the introduction, allo- Additionally, there is a ‘bookmarks’ file cation and cost effective use of medical to accompany the guide which can be technologies. The ninth edition of this downloaded to provide easy access to the guide focuses on websites that are likely to sources [http://www.ahfmr.ab.ca/publi- be of interest to those involved in HTA. cations/?search=Internet+sources+of+inf The sites listed in the guide tend to be ormation&type=1 ]. developed by non-profit agencies (such Contents: Introduction; Bibliographic as government-funded organisations and Databases; Fee-based Bibliographic universities), are updated regularly and Databases; Government & Research contain valuable information for HTA. Information; Clinical Trials; Practice The bibliographic databases identified Edmonton: Institute of Health Economics, Guidelines; Complementary & Alter- generally contain peer-reviewed studies, June 2007 native Medicine; Health Economics; while the HTA and evidence-based Quality of Life; Further Information; ISBN 978-0-9780024-7-3 health sources usually follow accepted Distance Learning in HTA; Evidence- methods for ensuring the comprehen- 26 pages Based Medicine; Critical Appraisal; siveness, transparency and reliability of Knowledge Transfer and Research Utili- Freely available online at: http://www.ihe.ca/ the methods used in their systematic sation; Listservs; Literature Searching documents/ihe/publications/reports/IHE_ reviews. The sites included are fairly Guides; Open Access (Free) Electronic Report_Health_Technology_Assessment_on_ easy to navigate and search. An effort Journals. the_Net_Jun_2007.pdf has been made to also include qualitative
Eurohealth Vol 14 No 1 38 Please contact Philipa Mladovsky at [email protected] to suggest web sites WEBwatch for potential inclusion in future issues.
Health Programme of the This section of the Slovenian Ministry of Health web site, available in Slovenian and English, contains Slovenian Presidency of information on conferences, ministerial meetings, and EU and WHO meetings taking place in the the EU framework of the Slovenian Presidency. http://www.mz.gov.si/en/predse dovanje_eu_in_evropske_zadeve
DIPex The DIPex English-language web site is aimed at patients, their carers, family and friends as well as health professionals as a teaching resource. The web site contains an open-access database of personal http://www.dipex.org experiences of around 40 conditions or health issues, built from systematic collections of hundreds of qualitative research interviews of people in the UK. The interviews are collected (maximum variation sampling) and analysed by experienced and trained social scientists. The site also provides information about each illness, answers to frequently asked questions, video clips, an online forum, press releases and academic papers.
European Agency for The Agency is a tripartite organisation, working with governments, employers and workers repre- Safety and Health at Work sentatives. Their web site provides a single reference point for occupational safety and health (OSH) information and is available in over 20 European languages. Information, guidelines for good practice http://osha.europa.eu and publications are available to download, searchable by topic, sector, country, priority group and other categories. Information on European legislation is made available, as well as sources of statistics. There is also information on the Agency’s campaigns, press releases and news and events. Linked to the main site is the site of the European Risk Observatory which provides information on OSH risks, emerging risks and OSH monitoring systems and surveys, by country.
German Reference Centre The English and German language web site of the DRZE comprehensively provides scientific infor- for Ethics in the Life Sciences mation which is required for a qualified formation of opinion and judgment in the area of ethics in the (DRZE) life sciences and medicine. A series of publications are available (mostly in German with English summaries) and a German and English language newsletter. BELIT, the Bioethics Literature Database, http://www.drze.de provides access to about 320,000 records from integrated German, American and French databases and a thesaurus of terms related to the field. A second database, BEKIS, lists academic institutions, projects, working groups, individual researchers and funding bodies working in the field of ethics in the life sciences throughout Europe. A diary of ethics-related events is also available.
Medical Women’s The MWIA is an international non-governmental organisation (NGO) representing women doctors International Association from five continents. The English-language web site provides publications on issues for women (MWIA) doctors, focusing on gender mainstreaming and health, adolescent sexuality, and domestic violence. Publications include articles, manuals, congress reports, annual reports and a newsletter. There is http://www.mwia.net information on events and links to related web sites.
The Netherlands Institute for NIVEL contributes to the body of scientific knowledge about the provision and use of health care Health Services Research services by carrying out research activities at the national and international level. Research focuses on (NIVEL) need for health care, supply of health care, the care process and health care policy. The Dutch and English language web site makes available hundreds of research papers (in both languages) to download http://www.nivel.eu through the searchable database as well as providing a news section.
39 Eurohealth Vol 14 No 1 MONITOR
EUROPEAN MONITOR we are not talking about the legislature. Mrs Vassiliou replied freedom of movement of that “like her predecessor, she New Health Commissioner services but about the right of was interested in continuing the approved by European citizens to get health care all efforts to fight tobacco” and Parliament over Europe”. Reacting to that it “is important not to The European Parliament has concerns raised by UK MEP impose rules but to make people voted in favour of approving the Linda McAvan she said that her understand”, adding that she new Commissioner for Public intention was “not to damage would make appropriate Health, Food Safety, Animal the existing health systems, but proposals in the forthcoming Health and Welfare, Androula to improve them by cooperation third report on the tobacco Vassiliou. and the exchange of the best products directive. practices available”. Mrs Vassiliou’s appointment Responses to written questions: follows the resignation of fellow Answering Adamos Adamou http://www.europarl.europa.eu/ Cypriot, Markos Kyprianou, from Cyprus on the planned hearings/commission/2008/ who left to take up the post of directive on organ safety, Mrs questionnaires/specific_en.pdf Vassiliou said that she intended foreign minister in the new Information on the Hearing: to introduce standards applying Cypriot government in http://www.europarl.europa.eu/ to organ donation, but that February. hearings/commission/2008/ these measures should not lead default_en.htm Prior to joining the Commission to excessive bureaucracy or Mrs Vassiliou practiced law in intervention if the system is €2 billion boost for Cyprus for twenty years before working, as for example, in pharmaceutical research becoming First Lady when her Spain. Replying to fellow On 30 April work began on husband, George Vassiliou, was Cypriot Marios Matsakis on implementing the Innovative elected President of the cancer screening, she added that Medicines Initiative (IMI), a Republic of Cyprus in 1988. In the Commission would examine unique public-private part- 1996 she was elected Member of whether the targets had been nership between the European the Cyprus House of Represen- reached in the Member States Commission and the European tatives representing the and, if appropriate, would Federation of Pharmaceutical Movement of United review the relevant EU Industries and Associations Democrats. During this period directive, to include other types (EFPIA). It aims to remove she was also a member of the of cancer that require early bottlenecks in the drug devel- Joint Parliamentary Committee screening. of Cyprus and the EU. opment process and cut devel- Asked by French MEP opment costs through During her three-hour confir- Françoise Grossetête about innovative research projects, and mation hearing before the what she intended to do in the News so accelerate the discovery and European Parliament Ms field of Alzheimer’s disease, she development of new medicines. Vassilou began by stating that responded by affirming her The initiative arises out of the “health is wealth and I am deter- commitment to the “primary EU’s Seventh Framework mined to work hard towards importance to mental health”. Programme for Research ensuring high standards for our Reacting to Greek MEP Evan- scheme on Joint Technology citizens, be they in Romania, gelia Tsambazi on guarantees for Initiatives (JTIs).These are Sweden, the UK or Cyprus”. the health and safety of the most meant to establish long-term, She also said she was vulnerable groups, like women, public-private partnerships on “committed to ensuring a firm young people and people with specific research areas, enforcement of EU law relating disabilities, she said that where combining private-sector to health by all Member States”. there was proof that these issues investment with national and Concerning the ongoing debates have an impact on public health European public funding. The on patients’ rights in cross- she would work with her novelty of these initiatives is border healthcare she said that colleagues to deal with them. that the research topics would she was “already working on Concerning people with disabil- be defined by industry. They the proposal and [is] determined ities, she would cooperate with also represent a move away to submit it for adoption by the Social Affairs Commissioner from the traditional approach of Commission in June.” She Špidla. Press releases and case-by-case public funding of agreed with UK MEP John other suggested Another subject that arose projects to concentrate Bowis who said that the information for during the Parliamentary resources on a few strategic proposal was needed soon to future inclusion hearing was the subject of issues, defined by industry in avoid policy being decided by can be e-mailed to tobacco. Dutch MEP Jules specific fields. One of six areas the Court of Justice and lawyers the editor Maaten questioned whether new earmarked for JTIs is innovative rather than politicians. She said David McDaid legislation on tobacco could be medicines. she would persuade critics “that [email protected] expected before the end of the
Eurohealth Vol 14 No 1 40 MONITOR
IMI has a total budget of €2 billion until synthesised in laboratories, only one or drink-driving, not wearing a seat belt and 2013. A first call for proposals for two will successfully pass all the stages failing to stop at a red light. These four research projects in the areas of brain to become marketable medicines. offences are the leading causes of acci- disorders, metabolic and inflammatory dents and road deaths: they are involved Until 1998 seven out of ten new medi- diseases was launched, with submissions in almost 75% of all road deaths. cines originated from Europe. Today due by 15 July. Some €123 million will this has fallen to about three out of ten. Since 2001, the EU’s goal in the field of be granted to the most promising It is hoped that IMI will boost Europe’s road safety has been to halve the number research projects in these areas later this competitiveness in biopharmaceutical of victims of fatal accidents in ten years. year. This will be augmented by funding innovation and foster Europe as the In that year (2001) 54, 000 people were from industry of €175 million. In future most attractive place for pharmaceutical killed on the roads of the twenty-seven calls IMI will also cover cancer and research and development. The pharma- Member States. In 2007, for the first infectious diseases. These areas have ceutical industry is a knowledge based time since 2001, there was no annual been chosen because they are, primarily, sector that has a huge impact on progress in cutting the number of deaths important areas of unmet medical need, employment for highly trained people. It on the roads: it was still 43,000. affecting the lives of millions of provided Europe with 612,000 high European citizens. As well as improve- In October 2003 the Commission skilled jobs in 2004, of which 103,000 ments in safety measurement and adopted a Recommendation dealing with were in research. Europe produces more prediction of efficacy, other bottlenecks best practice on enforcement in the field than 35 % of the world’s pharmaceutical that the IMI seeks to overcome include of road safety (2004/345/EC). The trend output, worth some €161 billion, knowledge management: supporting in accidents shows that this non-coercive making it the second most important safety and efficacy of projects, as well as instrument is not enough to achieve manufacturing location after the US. information sharing, modelling and results. simulation tasks, and gaps in education “IMI brings together experts from the More information at http://ec.europa.eu/ and training: supporting the medicine laboratory and the clinic working on transport/roadsafety/index_en.htm development process. new approaches to better predict as early as possible whether a drug works in a European Science and Research Health inequalities highlighted for patient and whether it is safe. Earlier Commissioner, Janez Poto nik, under- heads of states access by patients in need to new lined the ambitious goals ofč the initiative Social protection reforms and active effective treatments is the ultimate goal saying that “IMI is about pooling public inclusion policies have visibly of this joint initiative,” stated Jonathan and private efforts so that Europe can be contributed to higher growth and more Knowles, the chairman of the IMI a big player. We want to be the best in jobs in Europe over the past year. But governing board. the world and become a champion’s more needs to be done to ensure that league for biopharmaceutical research by The initiative also foresees the estab- these benefits reach those at the margins moving from individual project-funding, lishment by 2013 of a European Medi- of society and improve social cohesion, to joint programme funding involving cines Research Academy (EMRA), a says a Commission report discussed by industry and public stakeholders.” pan-European platform for educating Employment and Social Affairs and training current and future profes- Ministers. The 2008 Joint Report on Arthur Higgins, President of EFPIA and sionals involved in biomedical R&D, Social Protection and Inclusion focuses Chief Executive Office of Bayer Health including regulatory officers. on priorities and progress made in the Care, emphasised the need to join forces areas of child poverty, working longer, with partners to address the main cause More information on IMI, including the private pension provision, health of delays in drug innovation, noting that call for proposals is available at inequalities and long-term care. The “the challenges behind innovation are http://imi.europa.eu report was sent for discussion by heads complex, and the decline in the number of governments at the Spring European of new drugs is due to a combination of New Directive on road safety Council to highlight the social dimension scientific, regulatory and economic The Commission has adopted a proposal of the jobs and growth package. factors. We as an industry are ready to for a Directive aimed at facilitating the play our part in bringing forward cross-border prosecution of traffic 16% of EU citizens remain at risk of medical innovation but cannot solve all offences which imperil road safety. Tech- poverty while some 8% are at risk of these issues by ourselves”. He added nical measures and legal instruments are poverty despite being employed. Out of that the IMI is “a tremendous illus- to be put in place which will enable EU the seventy-eight million Europeans tration of how the European industry drivers to be identified and thus prose- living at risk of poverty, nineteen million can join forces with the EU and all the cuted for offences committed in a are children. Social policies have a major stakeholders like small and medium size Member State other than the one where impact on health and health is an enterprises, academia, patient groups, his or her vehicle is registered. It is important determinant of life chances. regulators and unlock the full innovation hoped that this will make an appreciable There are currently wide disparities in potential of Europe.” difference to road safety in Europe by health outcomes across the EU, with bringing about a positive change of men’s life expectancies ranging from 65.3 Drug development for a new chemical or behaviour in both non-resident and years (Lithuania) to 78.8 (Cyprus and biological candidate is estimated to cost resident drivers. Sweden) and those for women from 76.2 over €1 billion and takes on average 12.5 (Romania) to 84.4 (France). Health years to bring a new medicine to the The proposed Directive will cover four concerns could be adopted in all policies, market. Out of every 10,000 substances types of road traffic offence: speeding,
41 Eurohealth Vol 14 No 1 MONITOR including promoting healthy life styles, Demands for quality and quantity of involved in the provision of long-term while social protection could ensure long-term care services bound to rise, care services; access for all to quality healthcare and says EU report – Promoting home or community-based long-term care and promote prevention, The demands for and costs of long-term care rather than institutional care to including for those most difficult to care provision in the EU will rise signifi- help dependent people remain in their reach. cantly by 2050, according to a new own homes for as long as possible; The report is available at report presented by the European – Improving the recruitment and http://ec.europa.eu/employment_social/ Commission at a conference on inter- working conditions of formal carers spsi/joint_reports_en.htm#2008 generational solidarity organised by the Slovenian EU Presidency on 28 April in and supporting informal carers. European Commission consultation on Brdo. Meanwhile, the vast majority of Europe’s 80+ population is projected to Europeans (almost nine out of ten) providing information to patients rise from eighteen million in 2004 to favour home or community-based care The European Commission has nearly fifty million by 2050. If the addi- over care in an institutional setting. The launched a public consultation on a new tional life years are spent in ill health or projected growth in demand for long- proposal to ensure that information in need of assistance, the number of term care services presents a major chal- given to patients on prescription-only dependent persons would more than lenge for national governments. But the medicines reaches the highest standards. double by 2050. Under the more opti- report also shows that Member States A Commission report published on 20 mistic scenario which assumes that the are striving to guarantee access for all to December 2007 (under Directive increase of a disability-free life quality care by providing adequate 2004/27/EC), studied current practices expectancy will be in line with the gains resources to meet this demand. across Member States and concluded in life expectancy as such, there would that rules and practices on information The report reveals the challenges of long still be a 31% increase in the number of provision vary widely. It expressed term care in the future. It also shows dependent people. concerns that patients and the public that Member States are already This will lead to an increase in formal were not always able to find sufficiently preparing a wide variety of solutions and and informal care, so jobs will be created, detailed and reliable information on that there is also strong commitment at but expenditure is also likely to increase. prescription medicines. European level to provide access to According to projections in the report, quality care for all. “I am convinced that Following this, the regulations on infor- average public spending on long-term working together at European level gives mation provision will be harmonised so expenditure across the EU-25 countries Member States a unique added value and that a clear distinction is made between is expected to almost double from 0.9% helps them to improve care for our material which advertises a product and of GDP in 2004 to 1.6% in 2050. The vulnerable citizens by coordinating that which informs the consumer. It will most pessimistic scenario could see an strategies and setting common objec- be designed to ensure that patients even bigger rise to 2.3% of GDP. tives”, said Social Affairs Commissioner across the EU have access to clear, Vladimír Špidla. He added that “we According to a Eurobarometer report objective and reliable information. They should not close our eyes to reality but carried out in 2007, most Europeans will also establish quality criteria for all act now to ensure high-quality long- expect to need long-term care at some relevant information, ensuring patient term care now and for the future.” point in their lives (with an EU average access to unbiased objectivity, reliability of 13% seeing this as inevitable, 32% and clarity in the information they The Commission’s report, Long-term likely and 29% unlikely but possible). receive. Care in the European Union, analyses However, 86% of Europeans would the main challenges Member States face While maintaining the ban on direct to prefer to be cared for in their own in the field of long-term care, their consumer advertising of prescription homes or that of a relative should they strategies for tackling them and presents products, dissemination via the media of become dependent, as opposed to only possible solutions. It draws on the information on such products will 8% preferring an institution. national reports submitted as part of the continue, monitored by national regu- EU’s system of common objectives, The report can be downloaded at latory bodies established for this assessment and reporting for social http://ec.europa.eu/employment_social/ purpose and overseen by an EU-wide protection and inclusion – the ‘Open news/2008/apr/long_term_care_en.pdf Advisory Committee. This includes Method of Coordination’. It identifies Internet sites containing product infor- the main challenges for national govern- NEWSFROMTHEECJ mation, which could also be used to ments as: monitor any consumer complaints to Tougher stance on management of pharmaceutical companies. It will not be – Ensuring access for all to long-term pharmaceuticals by the ECJ? permitted to draw comparisons between care services; A case involving GlaxoSmithKline’s products and all statements must be – Securing financing for long-term care stock management policy of certain evidence-based, protecting consumers through an adequate mix of public and drugs in Greece was referred to the from any misleading claims. private sources of finance and European Court of Justice. The potential changes in the financing company’s policy in question involved More information at the limiting of quantities of products http://ec.europa.eu/enterprise/pharma mechanisms; sold to wholesalers to levels adequate to ceuticals/pharmacos/docs/doc2008/2008_ – Improving coordination between meet the needs of the Greek market. 02/info_to_patients_consult_200802.pdf social and medical services, often
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GSK stated that this policy was intended People who are unable to return home The Department of Health in England is to limit the levels of parallel trade from because of travel restrictions or because appealing the ruling. Greece. However, wholesalers claimed they are too ill have until now been that this policy was an abuse of a banned from free NHS treatment. These Wales: Failed asylum seekers to be dominant position. The case was people are deemed to be ‘ordinarily allowed NHS care prompted by a reference from the resident’, which means their return While legal proceedings are ongoing in Athens Court of Appeal of certain ques- home has been delayed for over a England, failed asylum seekers in Wales tions based on those raised in the earlier guideline period of more than six will now be given access to free NHS Syfait case. months. The judge said the existing care. Welsh Health Minister Edwina guidance was unlawful because the defi- Hart said her decision was the right one On 1 April 2008, the ECJ released nition of ‘ordinarily resident’ was not and that the mark of a civilised society Advocate General Ruiz-Jarabo’s restricted in time and authorities had was how it treated the sick and dying. opinion. He considers that a restriction discretion as to who qualified for ‘ordi- The opposition Conservative party said, of supply by a dominant pharmaceutical narily resident’ status. however, that while the NHS should be company in order to limit parallel trade open to emergency cases, they opposed can in principle be a breach of Article 82 The man whose case brought the issue to ‘health tourism’. of the EC Treaty. This is a much tougher the High Court is unable to return to the stance than the opinion of AG Jacobs West Bank owing to travel restrictions Previously, the Welsh Assembly had related to the Syfait case. AG Jacobs and problems over documentation. In his passed regulations to introduce charging took the view that given the particular 30s and known only as A, he applied for for secondary health care for refused characteristics of the pharmaceutical asylum when he arrived in England three asylum seekers. The regulations, which sector, such a restriction could be years ago. His case was rejected and he meant charges for all forms of secondary justified as a reasonable and propor- agreed to return to the West Bank. care, except treatment provided in tionate measure in defence of that accident and emergency departments, The Home Office provides him with company’s commercial interests. were passed in April 2004. accommodation and gives him £35 (€44) AG Ruiz-Jarabo does not agree that the per week to live on. But his local Speaking to BBC Radio Wales, Minister restriction is justified due to the negative hospital has refused to treat him as offi- Hart said that offering failed asylum impact of parallel trade on GSK’s incen- cially he is a failed asylum seeker, seekers free NHS treatment and putting tives to innovate. Overall, this opinion although he has been cared for while the it on a legitimate footing was the “right creates unwelcome uncertainties about case is heard. Adam Hundt, of human thing to do”. She referred to the parable the legality of stock management rights specialists Pierce Glynn and who of the Good Samaritan saying that “no- systems operated by pharmaceutical represented the man, said the rules were one would want to see a pregnant companies for dominant products. The leading to “grotesque human suffering”. woman turned away from hospital if ECJ’s judgment in the case is now “My client is effectively stuck in the UK, they were having difficulty with the awaited and the opinion of AG Ruiz- even though he is doing all that he can to pregnancy and people are fundamentally Jarabo is not binding. return home. He has never broken the decent and they will understand this law, and the Home Office recognises argument.” I’m simply looking at the The full opinion is available at that it has to provide him with accom- human being at the end of the chain and http://curia.europa.eu/jurisp/ modation so as not to breach his human saying if they’ve got severe health cgi-bin/form.pl?lang=EN&Submit= rights.” problems and they require help and rechercher&numaff=C-468/06 assistance, as a civilised country we He added that “it seems perverse that should give it.” COUNTRYNEWS housing is considered a basic human right and that health care is not.” The The Archbishop of Wales, Barry England: NHS ban on asylum seekers Terrence Higgins Trust (THT) said the Morgan, said he wholeheartedly ruled unlawful ruling would benefit those failed asylum supported the minister’s view that Wales In London on 11 April regulations seekers with HIV. Lisa Power, head of has a moral obligation to care for banning failed asylum seekers from policy for THT said: “the outcome of vulnerable people, regardless of their receiving free NHS treatment were this ruling is a sensible, humane decision asylum status. declared unlawful in England and Wales for many people we work with. If by a High Court judge. someone is living in the UK, they should Sweden tightens health care rules for be treated the same as any other illegal immigrants In Scotland, those who have applied for resident.” On 21 May Sweden’s parliament asylum or still within the asylum process approved the centre-right government’s are already entitled to free NHS Deborah Jack, chief executive of the proposal to deny subsidised public treatment until they leave the country. National Aids Trust, which helped bring health care services to illegal immigrants the case to court, said “for years failed Potentially the decision could have as of 1 July 2008. The law, which is asylum seekers have been denied free implications for 11,000 people currently largely a formalisation of current treatment for long term conditions awaiting removal from the UK. The practice, stipulates that illegal immi- including HIV. Many have faced ruling was made in the case of a Pales- grants and rejected asylum seekers can enforced ill-health as government policy tinian man who claimed that the denial only receive emergency medical care if has left them destitute and without of care for his chronic liver disease they pay for it themselves. health care.” breached his human rights.
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The parliament voted 265 to 33 in favour one might even say, granted the the Attendance Allowance resources of the proposal, with the left-wing constrained timetable, surprisingly previously paid to residents in care Green Party and Left Party voting well.” This was aided by strong resolve homes – providing savings … that against it on humanitarian grounds. The from the Scottish Parliament, the rapid should have been made available to vote was postponed by a day to allow actions of local authorities to implement benefit elderly people across Scotland.” for an extended debate. The government the policy, and support from the private The report can be accessed at plans to create a commission later this and voluntary sectors. http://www.scotland.gov.uk/ year to examine whether some illegal The review noted that “one response Publications/2008/04/25105036/0 immigrant groups should still receive which was less than supportive was that care. All parties in parliament are, for of the UK Department for Work and Russia joins global anti-smoking instance, in favour of giving illegal immi- Pensions (DWP) which ruled that convention grant children the right to subsidised Attendance Allowance should be with- On 25 April, the Russian Daily Novosti medical care. drawn from Scots receiving free personal reported that outgoing Russian Pres- Earlier Migration Minister, Tobias Bill- care in a residential setting and that the ident Vladimir Putin signed a law which ström, hinted that he is open to offering expenditure savings resulting should fall will see the country join the World some health care coverage to immigrants to DWP, rather than be transferred to Health Organization’s anti-smoking who find themselves in Sweden without the Scottish budget to offset the costs of convention. Under the convention, proper residence permits. As reported the policy. The sum in question is now which was ratified by Russia’s lower by the English language daily The Local, estimated to amount to around £30 house of parliament earlier in the month, he told a television channel (TV4) that million a year.” a tobacco advertising ban should be pregnant women and children lacking implemented within five years, and at The review concluded the policy had residence permits would be offered free least 30% of tobacco packets should proved popular and had few complaints health care. contain a health warning. in contrast to the situation in England. The suggestion entails providing free Twelve recommendations on the future The WHO Framework Convention on maternity care, care during childbirth, of free personal care were made, which Tobacco Control (FCTC), which was and health services to children. “You fall into three groups. The first group call adopted in 2003 and signed by more can’t punish children – born or unborn – for action in the short term and among than 150 countries, aims to help national for their parents’ decision to live here in other issues, are intended to address the governments curb smoking that kills five hiding,” he said. Refugees in hiding and immediate funding and variability of million people across the world undocumented immigrants without provision problems. In particular, it was annually. The signatories to the documentation are currently unable to noted that uncertainty associated with Convention are also encouraged to raise receive care without paying tens of thou- projecting future costs of long-term care taxes for tobacco producers, eliminate sands of kronor in healthcare costs. means demand and costs must be the illicit trade in tobacco products, ban reviewed and re-modelled regularly. tobacco sales to and by children, and Scotland: Review of free personal care promote agricultural diversification and In the medium term, because of the On 28 April, an independent review of alternative livelihoods for tobacco projected growth in the numbers of Free Personal and Nursing Care in producers. The death toll from smoking- older people, it was recommended that Scotland was published. The review was related diseases could increase up to ten there should be a further review of the commissioned by the Scottish million people a year by 2020, according scheme within five years. This should Government to look at the total levels to World Health Organization forecasts. look at better coordination of all sources and distribution of funding for the of funding from a holistic perspective, In recent years, tobacco producers have policy, and how to secure its long-term including UK government benefits such shifted their focus to the developing sustainability. Chaired by Lord as Attendance Allowance and Disability world, where about 70% of all tobacco Sutherland of Houndswood, previously Living Allowance. In the longer term, products are now sold. Russia is a major Chair of the Royal Commission on the they recommended that government at exporter of cheap cigarettes, with its Funding of Long-Term Care for Older all levels should seek to establish a new domestic production from multi-national People, the six strong panel comprised vision for dealing with the challenge of tobacco giants outstripping even Russia’s experts from nursing, social work, demographic change, not just looking at heavy consumer demand by some one dementia care and local government. long-term care, but also pensions, hundred billion cigarettes a year. The policy to provide personal and housing, transport, etc. Tobacco use has contributed greatly to nursing care in Scotland, which is free at Welcoming the report, Cabinet Secretary Russia’s demographic crisis. Although the point of delivery and assessed for Health and Wellbeing, Nicola Russia’s population of 143 million is according to need, was modelled on the Sturgeon, said that “Lord Sutherland roughly half that of the United States, Royal Commission Report With Respect confirms that the policy of Free Personal Russian tobacco use kills almost as many to Old Age published in 1999. The and Nursing Care (FPNC) has both people, some 400,000 per year. More relevant Act was passed by the Scottish widespread support, and is delivering than 60% of Russian men and up to Parliament in 2002. real benefits for tens of thousands of our 30% of Russian women smoke. The review found that the new policy most vulnerable older people. However According to Euromonitor Interna- “was implemented with expedition, and the report clearly states that the UK tional, Russia ranks fifth worldwide in on the whole the process has gone well; Government should not have withdrawn annual per-capita consumption, with
Eurohealth Vol 14 No 1 44 MONITOR some 2,665 cigarettes smoked, behind attempting to create more customer- even though the birth rate rose 8.3 % only Serbia, Montenegro, Greece and oriented but also cost-effective public and the mortality rate decreased by 4% Bulgaria. services. The proposed new system was in 2007, this favourable trend is unlikely based on the Dutch health insurance to continue beyond another five or six The head of the State Duma health system, which allowed private insurance years. Then population decline will set committee, Olga Borzova, earlier said companies to compete within a strictly in again. Russia could pass a national anti- regulated framework. Hungary even smoking strategy this year which would Outgoing President Vladimir Putin had employed former Dutch health minister comply with the WHO Convention made fighting the falling population a Hans Hoogervorst as an advisor on the requirements. In a report on global priority. The new report, while praising project. tobacco control efforts in February, the recent government efforts to increase the WHO urged greater commitment from The reforms attracted widespread birth rate and extend lives, argues that countries in implementing key tobacco resistance across many sections of not enough is being done to counter control measures, saying among other society. The opposition parties, led by stark demographic forces: an impending things that national governments collect the Alliance of Young Democrats– decrease in the number of women of five hundred times more money in Hungarian Civic Party (Fiatal child-bearing age, poor health care, tobacco taxes each year than they spend Demokraták Szövetsége–Magyar Polgári rampant road vehicle and industrial acci- on anti-tobacco advertising. Szövetség, FIDESZ-MPSZ), were also dents, widespread alcoholism and social heavily critical. The opposition high- conditions that discourage family With the addition of Russia, 154 nations lighted the widespread fear that the formation. have now ratified the tobacco control reform would eventually lead to the treaty. The United States and Indonesia, The UN Report suggests that by 2025 break-up of the universal social both of which are large manufacturers the population will already have shrunk insurance system and the introduction of and consumers of tobacco products, to 125 million. While children consti- a health insurance system based on remain the two most populous nations tuted 24.5 % of the Russian population competing insurance funds, similar to that have not ratified the treaty. in 1989, this had decreased to 16% by those found in the United States. 2007. By year 2023 the number of More information at http://en.rian.ru/ A large number of doctors also protested children born per year is expected to russia/20080425/105915892.html against the planned reform. As a result, drop to less than one million from its the government received virtually no current level of one and a half million. Hungary: Parliament repeals support for the proposed reform, with With the shrinking population it is esti- controversial health insurance law the exception of the support of the mated that the Russian labour market On 27 May, the Hungarian parliament employer organisations. A day of will then be in need of twenty-two repealed the Health Insurance Act, with national protest against the reforms had million more workers. only Free Democrat MPs voting against been held in November 2007. Despite the motion. 347 MPs voted in favour of Valeri Elizarov, principal author and this action, the Hungarian parliament repeal with only nineteen against and no Head of the Centre for Population passed the health insurance bill with abstentions. The for-profit twenty-two Studies at Moscow State University minor changes on 11 February 2008. regional health insurance funds estab- Economics Department, offered a set of lished under the Act, which can have However, in a referendum on 16 March concrete recommendations, which, in his minority (up to 49%) private share- voters rejected fees for medical opinion, could have an immediate holdings, will also be phased out. Several treatment and higher education. positive effect to counter the declining parts of the Act will remain in force, Inevitably this led to a reduction in the trend. He listed among low-cost including hospital waiting list regula- levels of investor confidence that would measures the necessity to restore the tions and measures designed to make be necessary to raise the private capital distorted information collection system pharmacies more profitable. needed for the new health insurance and to improve the knowledge of demo- system. Moreover, investor confidence graphic issues among civil servants and Health spokesman for the main oppo- was further dented by the knowledge parliamentarians. Other measures could sition party, Alliance of Young that the main opposition party, Fidesz, include tax benefits for those who have Democrats–Hungarian Civic Party which has promised to scrap the system more children, development of family (Fiatal Demokraták Szövetsége–Magyar if it comes to power in 2010, is well and child care infrastructure, and an Polgári Szövetség, or Fidesz), István ahead in the opinion polls. increase of family allowances to the level Mikola, said the government should of developed countries (2–3% of Gross account for the ‘dark era’ of eighteen UN in Russia warns of demographic Domestic Product). months of health care reform, the crisis Hungarian daily Népszabadság reported. More encouragingly, at the launch of the In Moscow on 28 April, Karl Kulessa, The planned health care reforms led to a report, Olga Sharapova, Director of the UN Population Fund chief in Russia, in crisis in the governing coalition and in Department for Medical and Social launching the new UN in Russia joint part caused the split between the ruling Issues of Families, Maternity and publication Demographic Policy in Socialists (MSZP) and their Liberal Childhood of the Ministry of Health Russia: From Reflection to Action said coalition partners (SZDSZ). and Social Development of the Russian that the population could fall from 142 Federation, cited preliminary results of The health care reform act had been part million to 100 million by 2050. The recent measures undertaken by the of a series of government measures that report, prepared by a group of inde- government. Several programmes have aim to reduce the budget deficit by pendent national experts, suggests that,
45 Eurohealth Vol 14 No 1 MONITOR been adopted, including those targeted at coalition partners have also put pressure involve any higher safety risks when decreasing mortality from cardiovascular on his governing Civic Democrats to compared to a classical mail order diseases and traffic accidents. The state exempt children and older people. The business where the products are has allocated ten billion roubles (€269 payments are very unpopular in the delivered directly to the consumer. million) for these programmes, which region: similar fees were overturned by a Therefore, the AMG and the ApoG did will be transferred to Russia’s regions. court in Slovakia and in Hungary by not prohibit this form of distribution. Maternity allowances are also to be popular referendum. However the However, the court also stated that, in an increased and measures are being taken Ministry of Health says the measure has ‘order-and-collect’ form of mail order, to improve the health services for been effective, noting that the number of the role of the pharmacy should be pregnant women and children. The prescriptions fell 40% in the first quarter limited to a logistical service only. construction of twenty-three specialised of 2008 compared to the same period last Consequently the pharmacy should not prenatal centres has also started. year. The Ministry estimate that it has give the impression that it is dispensing However, as Sharapova put it, “the avoided 1.75 billion koruny (€70 the relevant medicinal products or that discussion of the report will give a million) on medicine costs in the first the consumer is entering into a contract strong impetus in identifying, which three months of this year. with the relevant pharmacy. aspects we should still work on.” Furthermore, any advertisements Germany: Federal Administrative Court conveying these impressions should not The report can be freely downloaded at permits mail order businesses to be used. http://www.undp.ru/index.phtml?iso= RU&lid=1&cmd=publications1&id=73 cooperate with pharmacies The Federal Administrative Court in Spain: New court ruling on the pharmaceutical patent system Czech Republic: court rules in favour of Leipzig (Bundesverwaltungsgericht – BVerwG) ruled on 13 March 2008 that A ruling of the Provincial Court of patient charges cooperation between mail order busi- Barcelona has confirmed that pharma- On 28 May in Brno, the Czech Consti- nesses and pharmacies for the purpose of ceutical companies in Spain are not tutional Court ruled that the ordering and supplying medicinal permitted to manufacture generic government has the right to charge fees products to consumers is permitted versions of pharmaceutical products for patients using the health care system. under the provisions of the German Act manufactured by other pharmaceutical The government began charging 30 on Medicinal Products (Arzneimit- companies. Whilst this ruling does not koruny (€1.19) per doctor’s visit or telgesetz – AMG) and the German create new legal rights, it does widen the prescribed drug and 60 koruny (€2.28) Pharmacy Act (Apothekengesetz – scope of the existing law. for a day in hospital in January 2008. ApoG). When Spain joined the EU it enacted The upfront payments, for which local The AMG has permitted medicinal legislation creating a patent system. This opinion polls show a high level of public products to be supplied by mail order did not, however, offer patent protection opposition, were intended to reduce businesses since 1 January 2004. Based for pharmaceutical products. As a result, unnecessary visits to the doctor and use on this, the Dutch mail order pharmacy, European patents for pharmaceutical of medications. The Organisation for Europa Apotheek Venlo, concluded an products were also unenforceable in Economic Cooperation and Devel- agreement to cooperate with the Spain. Subsequently, Spain became part opment (OECD) says Czechs see a German pharmacy chain, dm-drogerie. of the World Trade Organisation and doctor more than anyone else in Europe Under this cooperation, orders from ratified the TRIPS/ADPIC Agreement at 13.2 visits per year, compared to the consumers for medicinal products can be which provided minimum standards of OECD average of 6.8 visits a year. deposited at a pharmacy operated by industrial protection between the rati- The Czech Constitution states that dm-drogerie and then collected after fying states. The TRIPS/ADPIC Czechs have the right “to free medical three days. However, the municipal Agreement entered into force in Spain care,” but “under the conditions defined government in Düsseldorf prohibited on 1 January 1996. by law.” The court’s decision was a this practice in 2004. dm-drogerie The pharmaceutical industry in Spain victory for Prime Minister Mirek successfully appealed against this prohi- had argued that the TRIPS/ADPIC Topolanek’s government, which insti- bition at the Administrative Court of Agreement altered the Spanish patent tuted the payments at the start of the Appeal in Münster in 2006. This appeal system and, thus, revoked the restriction year as part of a broader reform of has now been upheld by the Federal on patentability of pharmaceutical public finances. The court said that it did Administrative Court in Leipzig. products. This argument was supported not want to play a political role. If the The Federal Administrative Court by the Barcelona court which ruled that court intervened, it could “close the justified its decision on the basis that the product patents will be enforceable in door on any reform efforts,” said Judge distribution of medicinal products by Spain even if they had been requested Stanislav Balik, reading an explanation of collection from a designated pick-up prior to October 1992 (i.e. prior to the the court’s decision. Health Minister point is a common business method for end of the restriction on patentability of Tomas Julinek said the decision was mail order companies. Thus, this form of pharmaceutical products). Furthermore, ‘good news for patients’ distribution comes within the term ‘mail the court established that patents that The court said that the fees could still be order business’ under section 43(1) of had been granted before the TRIPS/ rolled back in Parliament. The leading the AMG and section 11a no. 1 of the ADPIC Agreement entered into force opposition party has promised to ApoG. The court held that the ‘order- will also be enforceable. The court stated abolish them. Topolanek’s junior and-collect’ form of mail order did not that, “we consider that the TRIPS/
Eurohealth Vol 14 No 1 46 MONITOR
ADPIC Agreement cannot be ignored in Anton Tishchenko died in intensive care clubs of bottles of strong alcohol, Spain”. The ruling also established a in a hospital in the city of Kramatorsk in including spirits, and raising tax levels “supervened patentability” for those Donetsk Region after he had been given on strong beer. ‘Le open bar’ – where patents that fall under the protection of the vaccine. Although a special patrons pay a fixed fee to drink all night the TRIPS/ADPIC Agreement. commission of the Ministry of Health is – would also be banned. The legal age at still investigating the case, the Minister which people can buy alcoholic drinks Greece: Government to ban smoking in of Health stated that preliminary results might also be raised: currently teenagers public places by 2010 provide no evidence of vaccination aged between 16 and 18 are allowed to The Health Ministry has announced that causing this tragic death. buy beer and wine. it will gradually ban smoking in public The WHO, the United Nations The tougher measures were necessary, places, such as cafes and restaurants, by Children’s Fund (UNICEF) and the the report said, after preventative and 2010. Although 46% of men and 31% of Centers for Disease Control and educational action had not been “suffi- women are regular smokers, the stricter Prevention (CDC) in a statement said cient in altering trends” in binge measures, aimed at protecting smokers that they regret the suspension of the drinking in France. Research indicates and non-smokers, have the backing of national measles and rubella vaccination that the number of French people most Greeks. According to a recent campaign. They argued that the decision indulging in frequent bouts of heavy survey, eight in ten Greeks believe that will have long-term implications not drinking has risen steadily in recent banning the habit from all public places only for the campaign but for other years. Half of all seventeen year olds is not an infringement on personal routine immunisation coverage, resulting admitted getting excessively drunk at rights. Additionally, 73% agreed that the in the potential for outbreaks of other least once in the last month, while a reduction of smoking should be a target infectious diseases. They also regretted small minority confessed to binge in national government policy. The the decision to suspend vaccination prior drinking more than twice a week. The authorities are also planning to launch a to the outcome of the investigation into university town of Nantes banned marketing campaign aimed at preventing Mr Tischenko’s death. They called on happy hours in October, following the young people from taking up smoking. the government to complete its full drowning of two students in the Loire Those who flout the new laws can investigation into this death in order to River after leaving a night club drunk. expect to incur sizable fines and other restore public trust in immunisation. Many bar owners object to the bans, penalties. The three organisations reiterated that however, especially in the wake of a new Offending smokers may earn proprietors the measles and rubella vaccine used in law prohibiting smoking in bars and fines as high as €3,000. The non- Ukraine is pre-qualified by WHO and restaurants. Speaking to French daily, Le smoking act will further prohibit produced in accordance with the highest Parisien, Patrick Malvaës, President of tobacco sales to minors. Tobacco international standards by the Serum the Union of Discos and Places of products will be on sale in specialist Institute of India, the largest producer of Leisure said “I don’t see how these shops, while the sales of cigarettes by the measles and rubella vaccine globally. measures will resolve the problem of piece will be banned, as well as that of Two out of three children in the world alcoholism. To get rid of happy hours is packets containing less than 20 cigarettes. are immunised against measles with ridiculous.” vaccine from this manufacturer. They While the health ministry said that the Ukraine: National measles and rubella stated that this measles–rubella vaccine measures were “proposals at this stage”, has an excellent track record and has vaccination campaign suspended the government is reportedly keen to the been successfully used in countries Measles and rubella are highly conta- see them through. “Alcoholism is a across Europe and the Commonwealth gious infections and can lead to severe scourge and all available means are of Independent States (CIS), immunising complications, birth defects and death. welcome to fight it,” said one doctor over thirty-four million young people. In 2005–2006, Ukraine experienced large consulted in drawing up the planned The rubella vaccine from the same outbreaks of measles, infecting over rules. According to Etienne Apaire, head manufacturer has been used in Ukraine 50,000 young people that accounted for of a government body in charge of the since 2002, successfully vaccinating over 80% of measles cases in Europe. Over fight against addiction to drugs or 1.3 million people. 20,000 young Ukrainians contract alcohol, the proposed measures are being rubella annually and a large outbreak of More information at discussed with producers and distrib- over 100,000 cases occurred in 2002, http://www.euro.who.int/mediacentre/ utors of alcoholic drinks and some deci- resulting in serious birth defects. PR/2008/20080521_1 sions are expected within weeks. The However, following the death on 13 May move is the latest action against excess of a 17-year-old boy after use of a France: Happy hour ban to curb youth drinking: in February Prime Minister measles vaccination in the Donetsk drinking considered Francois Fillon indicated that new laws Region, and the subsequent hospitali- On 19 May it was reported that France would be introduced to confiscate the sation of over sixty people in eastern is planning to ban ‘happy hours’ in bars vehicles of drunk drivers. He also Ukraine, the Ministry of Health has in a bid to stem the rise of binge promised the prohibition of the alcohol called a moratorium on mandatory vacci- drinking. The leaked government sales in service stations and the auto- nation against measles and rubella. The proposals follow calls from doctors and matic confiscation of the license in the President of Ukraine, Viktor politicians to tackle excessive alcohol event of vehicular homicide. Yushchenko, has insisted that vaccination consumption. The cross-ministry report is carried out on a voluntary basis only. also calls for a ban on the sale in night-
47 Eurohealth Vol 14 No 1 News in Brief
WHO European Ministerial Launch of Trencín Statement on Injury statistics in the EU Conference on Health Systems prisons and mental health The report, Injuries in the European Organised by WHO Regional Office for Union – Statistics Summary 2003–2005, On 24 June 2008, at the London-based Europe and hosted by the Government launched on 3 April 2008, clearly shows Sainsbury Centre for Mental Health, the of the Republic of Estonia, Health Sys- that injury remains one of the biggest Trencin Statement on Prisons and Men- tems, Health and Wealth will take place health threats facing Europe today. Pub- tal Health will be launched. It aims to in Tallinn on 25–27 June 2008. Ministers lished by Eurosafe, the European Asso- draw the attention of all countries in Eu- of health from the 53 Member States in ciation for Injury Prevention and Safety rope to the essential need for a greater the WHO European Region and up to Promotion, it indicates that there are ap- focus on mental health problems among 500 participants are expected to attend proximately 250,000 fatalities each year people in custodial settings. Of the nine the event. High-level delegations will be in the EU, the fourth major cause of million prisoners world-wide, at least invited, as well as health systems part- death. Only cardiovascular diseases, one million suffer from a significant ners, experts, observers and representa- cancer and diseases of the respiratory mental disorder, and even more suffer tives of international and civil society system claim more lives. Sixty million from common mental health problems organisations and the media. The confer- people in the EU receive medical treat- such as depression and anxiety. There is ence aims to improve understanding of ment each year as a result of an accident often co-morbidity with conditions such how health systems not only impact on or injury. Making use of current injury as personality disorder, alcoholism and health but also on economic growth. It data at EU27 level, the new report pro- drug dependence. also takes stock of recent evidence on ef- vides a statistical overview on different fective strategies to improve the per- The statement highlights that without sectors of injury prevention such as traf- formance of health systems, given the urgent and comprehensive action, pris- fic, work place, and home and leisure. increasing pressure on them to ensure ons will move closer to becoming For the report and other injury statistics sustainability and solidarity. twenty-first century asylums for the see https://webgate.ec.europa.eu/idb mentally ill, full of those who most re- More information at quire treatment and care but who are http://www.euro.who.int/ Better outcomes through health held in unsuitable places with limited healthsystems2008 reforms in the Russian Federation help and treatment available. The event A new discussion paper Better Outcomes is organised by the WHO Health in Physical activity affected by social through Health Reforms in the Russian Prisons Project, in collaboration with its status Federation: The Challenge in 2008 and Collaborating Centre, the UK Depart- Beyond has been published by the World Move for Health Day 2008 on 10 May ment of Health and the Sainsbury Cen- Bank. Written by Patricio Marquez it put an emphasis on physical activity is tre for Mental Health. Previously the looks at selected health challenges in the for all. Its primary aims were to increase statement was adopted by twenty-eight Russian Federation, focusing on out- public awareness of the benefits of phys- European Member States present at a comes, expenditures and options for pol- ical activity in the prevention of non- mental health conference held in icy and institutional reforms in the communicable diseases and to draw Trencín, Slovakia in October 2007. attention to good practice. One in five health care system. The areas covered in people in the WHO European Region is More information at http://www.euro. the paper draw on recent studies and re- now inactive and socioeconomic status who.int/prisons/20080428_4 ports, and take into account lessons de- influences our level of physical activity. rived from the World Bank-funded People with lower incomes have dispro- Netherlands: Government to publish Health Reform Implementation Project portionately higher rates of the chronic vision on drug policy (HRIP) at the federal level and in the diseases and obesity associated with less On 19 March, during a parliamentary Chuvash Republic and the Voronezh physical activity and unhealthy eating debate, Health Minister Ab Klink an- Oblast – the pilot regions of the project, patterns. Although poorer people are nounced the development of an inte- over the 2005–2007 period. more likely to walk or cycle to shops or grated policy document on the future of The paper is freely available at work than those with higher incomes, drug policy. The document will include http://siteresources.worldbank.org/ they are less likely to be active in their an evaluation of the results of the Dutch HEALTHNUTRITIONANDPOP leisure time. The mechanisation of government’s policy of tolerance ULATION/Resources/281627-10956981 labour has brought about a general ho- (gedoogbeleid), as well as making a com- 40167/MarquezRussianHealth mogenisation of levels of work-related parison between Dutch drug policy and Reforms.pdf physical activity among social groups. that of other countries. The Minister Thus, socioeconomic differences in also plans to commission research into overall physical activity are more likely the damaging impact of various types of Additional materials supplied by drugs, including alcohol and tobacco. to result from variations in leisure-time EuroHealthNet pursuits than in activities related to There will also be a risk analysis of the 6 Philippe Le Bon, Brussels. other areas of life. damaging effect of cannabis. The new drugs policy document, including details Tel: + 32 2 235 03 20 More information available at of research, is expected to be published Fax: + 32 2 235 03 39 http://www.euro.who.int/moveforhealth in spring 2009. Email: [email protected]
eurohealth Vol 14 No 1 48 Eurohealth is a quarterly publication that provides a forum for researchers, experts and policy makers to express their views on health policy issues and so contribute to a constructive debate on health policy in Europe
ISSN 1356-1030