Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.

The Austrian healthcare system relies mainly on physicians in private practice and on various services provided by hospitals. The social health insurance scheme is compulsory, covering 99% of the population. The system is very decentralized. While the federal state provides the framework, the nine autonomous provinces are responsible for administering health and social services. There is ongoing public discussion about centralizing the healthcare system to make it more efficient and to enforce structural reforms. Because of concerns about healthcare expenditures, in 1997 the Performance-Related Hospital Financing System (LKF), a system similar to the diagnosis-related group system,was introduced for hospitals, including a plan for large medical devices. It is too early to evaluate the success of this new system, although some effects of the LKF system that could have been anticipated, such as shortened lengths of stay and more hospitalizations, have been seen. Previously, health technologies have been almost uncontrolled in Austria. The evaluation of health technologies as an instrument to support or to control their dissemination and use or to help define policies is not institutionalized or systematically used. It seems clear that structural reforms of the Austrian healthcare system are needed. Health technology assessment should be part of such reforms.

The Belgian healthcare system has a Bismarck-type compulsory health insurance, covering almost the entire population, combined with private provision of care. Providers arepublic health services, independent pharmacists, independent ambulatory care professionals, and hospitals and geriatric care facilities. Healthcare responsibilities are shared between the national Ministries of Public Health and Social Affairs, and the Dutch-, French-, and German-speaking Community Ministries of Health. The national ministries are responsible for sickness and disability insurance, financing, determination of accreditation criteria for hospitals and heavy medical care units,andconstruction of new hospitals. The six sickness and disability insurance funds are responsible for reimbursing health service benefits and paying disability benefits. The system's strength is that care is highly accessible and responsive to patients. However, the healthcare system's size remained relatively uncontrolled until recently, there is an excess supply of certain types of care, and there is a large number of small hospitals. The national government created a legal framework to modernize the insurance system to control budgetary deficits. Measures for reducing healthcare expenditures include regulating healthcare supply, healthcare evaluation, medical practice organization, and hospital budgets. The need to control healthcare facilities and quality of care in hospitals led to formal procedures for opening hospitals,acquiring expensive medical equipment, and developing highly specialized services. Reforms in payment and regulation are being considered. Health technology assessment (HTA) has played little part in the reforms so far. Belgium has no formal national program for HTA. The future of HTA in Belgium depends on a changing perception by providers and policy makers that health care needs a stronger scientific base.

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, co-ordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.

Finland has a long tradition of supporting social programsthat promote equality and the welfare state.The healthcare system is financed mainly by taxation. Everyoneis insured against illness. Each of Finland's five provincesis run by a provincial government that monitors the provision ofsocial welfare and health care. However, the municipalitiesactually provide the services and regulate medical equipmentand regionalization of services. During the early 1990s, gross domestic product(GDP) fell dramatically, and healthcare expenditure rose to 9.4% ofGDP. Due to the economy's rapid recovery, the share of healthcare expenditure has again decreased and now matchesthe average level of OECD countries of approximately 7.7 %. Theformer Finnish method ofcentral planning and norm setting has guaranteed a fairlyuniform development of necessary services throughout thecountry and free or low-cost access. Tight central planningdid not, however, create incentives to contain costs. Therefore, in the beginning of the 1990s, decision-making powerwas largely decentralized to the municipalities, and theprinciples of state subsidies were reformed. In 1995, theFinnish Office for Health Care Technology Assessment (FinOHTA)was set up as a new unit of the National Research andDevelopment Centre for Welfare and Health (STAKES). FinOHTA is intendedto function as a national central body for advancingHTA-related work in Finland, with the ultimate goal of promoting the effectiveness and efficiency of Finnish health care. Atpresent, the importance of HTA is widely recognized in Finland,especially in the face of rising healthcare costs.

The French healthcare system combines freedom of medical practice with nationwide social security. Itis compulsory for every legal resident. A range of public and private institutions provide care, and patients have free access to physicians. The health coverage system is characterized by solidarity and universal responsibility. Although the French system is highly regulated, funding of health-related expenses is a chronic social problem. Since the 1996 healthcare reform, the national objective for reimbursed healthcare expenditures is voted by the parliament, and the annual increase of hospital funding is controlled at the regional level. An agency for hospitals has been established in every region, and it quantifies needs indexes for future equipment and beds. However, establishing appropriate reference ratios based on objective assessment is difficult. The idea of basing policy and practice decisions on objective assessment grew for years, until the National Agency for the Development of MedicalEvaluation was established in 1989. The 1996 healthcare reform expanded this agency to encompass hospital accreditation and renamed it the National Agency for Accreditation and Evaluation in Health. In March 1999, the National Agency for Health Products was established. It controls the safety ofmedical products and evaluates products' medical benefits before reimbursement decisions. Health technology assessment is now related to virtually every health policy process in France, and its role increases continually.

The objectives of this paper are to describe the status anddevelopment of health technology regulation with regard to coveragedecisions and utilization, and to analyze the current situation ofhealth technology assessment (HTA) in Germany. The relevantliterature for controlling health technologies was identified bysearching the literature and databases and through personal contacts. Theliterature was analyzed with regard to the different sectors in thehealthcare system. For the analysis of the current state of HTA in Germany, a national survey was carried out. In addition, the names of topicsunder assessment were collected. The results show that coverage decisions in the ambulatory sector appear to be much more regulated than those in the inpatient sector. The same is true for diffusionand usage of technologies. The strict separation of the hospitaland the ambulatory care sector in Germany constitutes a barrier toregulation and to making HTA an effective instrument inGermany. Until recently, HTA in Germany focused onbiotechnology, such as gene technology. Recently the German ScientificWorking Group of Technology Assessment in Health Care has adopted asystematic methodology to undertake HTAs.It can be concluded that regulation of health technologies inGermany is characterized by inconsistencies ranging from strictregulation in the ambulatory sector to almost no regulation in therehabilitation sector. Increasing interest in HTA, in conjunctionwith a high priority assigned to evaluation of health technologiesby the newly elected government, is likely to improve this situationin the future.

In 1983 a health reform aimed to assure universal coverage and equity in the distribution of services in Greece. The reform implied state responsibility for the financing and delivery of services and a reduction of the private sector. The model was a Bismarckian scheme for social insurance. However, healthcare deliveryremains fragmented and uncoordinated and the private sector is getting stronger. The dominant payment system is fee-for-service for the private sector and administered prices and salaries for public hospitals and social insurance funds. The many insurers have their own eligibility requirements, validation procedures, etc. Coverage of services by social security funds, probably among the most comprehensive in Europe, is determined more on historical and political grounds than on efficiency or cost-effectiveness. The system is plagued by problems, including geographical inequalities, overcentralization, bureaucratic management, poor incentives in the public sector, open-ended financing, inefficient use of hospital beds, and lack of cost-effectiveness. There are no specific legal provisions for the control of health technology. Technologies are introduced without standards or formal consideration of needs. There are no current efforts to control health technology in Greece. However, health technology assessment (HTA) has gained increasing visibility. In 1997 a law provided for a new government agency responsible for quality control, economic evaluation of health services, and HTA. The hope is that the new law may introduce evaluation and assessment elements into health policy formulation and assure that cost effectiveness, quality, and appropriate use of health technology will receive more attention.

Ireland's health system is primarily funded from general taxation and is publicly provided, although private health care retains a considerable role. It is a unique structure, a mixture of universal health service free at the point of consumption and a fee-based private system where individuals subscribe to private health insurance that covers some of their medical expenses. The recent history of the Irish health services saw consolidation of existing services and an expansion into new areas to adapt to changing practices and needs. There has also been a drive to extract maximum efficiency so as to maintain the volume and quality of patient services at a time of very tight financial constraints. Introduction of new health technologies continued to accelerate. New technologies tended to spread rapidly before systematic appraisal of their costs and benefits. When the state is involved in funding the public hospital system, acceptance of new technology is a matter for discussion between agencies and the Department of Health and Children. Decisions about spending annual “development funding” have generally not been based on careful assessment of proposals for new technology. In 1995, a healthcare reform put new Public Health Departments in Health Boards in a prime position in Ireland's health services organization. These departments now emphasize evidence-based medicine. While Ireland does not have a national health technology assessment (HTA) program, there are plans to form an advisory groupon HTA in 1998. HTA is seen as a significant element of future health policy in Ireland.

Italy has a national health service (SSN) dating to 1978. Italy'ssystem of government is characterized by a rather high degree ofdecentralization of power, and the health system is likewisedecentralized. Most of the responsibilities for health care havebeen ceded to the regions. The state retains only limitedcoordinating and supervisory powers. The state has a financialresponsibility for the national health service, but statecontributions are limited and expenditures in excess of this made bythe region must be financed from other sources. Health reforms of1992–93 aimed at making the regions more sensitive to the need tocontrol aggregate expenditure and to monitor measures to promote efficiency,quality, and citizen-patient satisfaction. The diffusion of individualhealth technologies has been relatively uncontrolled in many regionsin Italy, although tight central constraints on capital spending havecontained diffusion of new technology. Regulation of placement ofservices is a planning function and is the responsibility of both theMinistry of Health and the regions. Health technology assessment(HTA) activities have been expanding since the early 1990s, but theseactivities tend to be untargeted, uncoordinated, and withoutpriorities. Nonetheless, the principal actors in the SSN at national,regional, and local levels are becoming more sensitive to the need toapply criteria of clinical and cost-effectiveness and to be morerigorous in deciding what services to guarantee. There are reasons tobe guardedly optimistic about the future of HTA in Italy.

Luxembourg's public health insurance is a compulsory insurancefor all employees, self-employed professionals, farmers, andpensioners. It is financed through contributions of the insuredpeople, as well as by state taxes. Providers of health care aremainly private nonprofit institutions and self-employedprofessionals. All healthcare procedures are defined in feeschedules determined by a common decision of the Ministers of SocialSecurity and Health according to proposals of a board of experts. Therelative value of a service is also determined by the correspondingfee schedule. Hospitals are financed by individual budgetsnegotiated between each hospital and the health insurance. Thesehospital budgets do not cover services provided in hospitals bymedical specialists, who are reimbursed on a fee-for-service basis. Alaw on hospital planning and organization allows the government torestrict the installation in hospitals of very expensive equipment orof equipment for which there is only a limited need in Luxembourghospitals. Until recently there has been limited interest in or useof health technology assessment (HTA). However, large hospitalinvestments have provoked some interest in the last few years. TheMinistry of Health has asked for some HTA studies when a concretedecision had to be taken. Luxembourg decision makers have becomemore aware that HTA may help them to become more informed about theshort- and long-term consequences of the application of healthtechnology.

The Dutch healthcare system is not a single overall plan, but has evolved from a constantly changing mix ofinstitutions, regulations, and responsibilities. Theresulting system provides high-quality care with reasonableefficiency and equal distribution over the population. EveryDutch citizen is entitled to health care. Health insuranceis provided by a mix of compulsory national insurance andpublic and private insurance schemes. Hospitals generallyhave a private legal basis but are heavily regulated.Supraregional planning of high-tech medical services is alsoregulated. Hospitals function under fixed, prospectivebudgets with regulation of capital investments. Independentgeneral practitioners serve a gatekeeper role for specialistand hospital services and are paid by capitation or fee forservice. Specialists are paid by fee for service. Allphysicians' fees are controlled by the Ministry ofEconomic Affairs. Coverage of benefits is an importantmethod of controlling the cost of services. There isincreasing concern about health care quality. Healthtechnology assessment (HTA) has become increasingly visibleduring the last 15 years. A special national fund for HTA,set up in 1988, has led to many formal and informal changes.HTA has evolved from a research activity into policyresearch for improving health care on the national level. In1993 the government stated formally that enhancingeffectiveness in health care was one of its prime targetsand that HTA would be a prime tool for this purpose. Themost important current issue is coordination of HTAactivities, which is now undertaken by a new platformrepresenting the important actors in health care andHTA.

The Portuguese healthcare system is often portrayed as a NationalHealth Service (NHS) model, characterized by universal coverage, comprehensive benefits, nearly free services, national tax financing, andpublic ownership or control of the factors of production. However, inreality the system fails to accomplish these features in a completeway. There coexist a number of occupation-related healthinsurance schemes that were originally intended to be integrated intothe NHS. In addition, in key areas the NHS does not provide the widerange of services it promises. The public sector has a predominantrole in the provision of hospital stays and general practitionerconsultations, but the private sector provides a major portion ofspecialist consultations, dental consultations, and diagnosticservices. Major problems in the system led to health reforms in the1990s. New reform proposals include some specific steps concerninghealth technology, including standards for medical equipment based onquality, geographic distribution, sustainability, andcost-effectiveness. A new National Plan of Health Equipment wascompleted in 1998, aimed at improving the distribution of equipment.Despite reforms, healthcare expenditures continue to rise. There is general agreement that gains in efficiency could be made. Thissituation is beginning to encourage interest in healthtechnology assessment (HTA) in Portugal, although these activitiesare not yet very developed. Recently, legislation requiring presentation of economic evaluations for new pharmaceutical productswas enacted. Present plans also call for the creation in the future of a national agency for HTA.

The Spanish Constitution of 1978 established a healthcare system available to everyone and free at thepoint of service. The General Health Law of 1986 also established the framework for a National Health System (NHS). The Constitution and the law form the regulatory framework for the devolution of healthcare services to the Autonomous Regions. All the 17 Autonomous Regions have complete power regardingpublic health and planning. However, responsibilities on healthcare financing, organization,provision, and management have devolved to only seven Autonomous Regions.Financial support for health servicescomes mostly from taxes. Global budgets are a mechanism used by hospitals to control the acquisition ofmedium and low health technology. Major capital investments for health technology are controlled by the central government in 10 Autonomous Regions (population coverage of 38%) and by the Regional Health Services in theseven remaining Autonomous Regions. In 1995 a regulation for basing the introduction of new procedures and medical equipmenton the assessment of safety, efficacy, and efficiency was issued. Health technology assessment(HTA) has a long history in Spain, beginning with the Advisory Board on High Technology in thegovernment of Catalonia in 1984. This board evolved into the Catalan Agency for HTA (CAHTA) in 1994. The Basque Country established a unit for HTA in 1992 (Osteba) and the Andalusian government created an agency in 1996 (AETSA). A national agency for HTA (AETS) was established in 1994. These different programs coordinate their work and together act as an Advisory Committee of the Interregional Council of the NHS.

Sweden has a welfare system that is based on the fundamental principle that all citizens are entitled to good health and medical care, regardless of where they live or what their economic circumstances are. Health and medical care are considered to be public sector responsibilities. However, there is growing interest in establishing more private alternatives to public care. An important characteristic of the Swedish healthcare system is its decentralization, with a major role for county councils. County councils are now merging into larger administrative units (region). The whole Swedish system is in the process of reform, mainly because of perceptions that it was too rigid and had insufficient patient orientation. An important factor in the reforms is that power in the system will be even more decentralized and will have greater public input. This change is seen as calling for increased central follow-up and evaluation of matters such as social, ethical, and economic aspects. Although the state has decentralized control, it still attempts to control the general direction of the system through regulation, subsidy, recommendations, and guidelines. An important actor in the system is the Swedish Council on Technology Assessment in Health Care (SBU). SBU began in 1987 with assessments of health technologies, but its success has recently led policy makers to extend its coverage to dental care. Health technology assessment is increasingly visible to policy makers, who find it useful in decision making.

Switzerland has a mixed public and private healthcare system. All citizens are enrolled in compulsory basic health insurance. A 1996 law allows people to choose among different sickness funds and managed care plans. The federal government is empowered to act on important health issues, but the 26 cantons have prime responsibility in health care and social welfare. They have their own laws on health care, hygiene, hospitals, and social welfare. These laws are not harmonized. The system is complex, with a mix of public (mainly hospitals) and private (mainly doctors' offices) providers. The health services are decentralized. Ambulatory care was traditionally provided in doctors' offices, but the last decade has seen the development of centers for day surgery, group practices, and managed care plans. Decisions on placement, location, and extension of services are decentralized. The payment system is very complex. Current trends include global budgets, cost analyses, and prices related to patient categories. However, coverage policy is developed centrally and includes both traditionally established services and new technologies. New technologies are added to the list only after evaluation by the Federal Coverage Committee. The coverage process integrates health technology assessment (HTA). Coverage can be granted in stages, including limited coverage and temporary coverage. Technologies and coverage can be reevaluated on the basis of registries or assessment information. The structure of the Swiss healthcare system does not lend itself to the establishment of a national HTA program. However, recent moves include the development of a coordinating mechanism for HTA in Switzerland.

The National Health Service (NHS) provides universal health coverage for all British citizens. Most services are free of charge, although modest copayments are sometimes applied. About 11% of the population also has private insurance. General practitioners, generally the first point of contact for accessing the system, are independent contractors who serve as gatekeepers for specialist and hospital services and enjoy substantial clinical autonomy. Hospitals are public and are regionalized, but the 1990 reforms made them self-governing trusts that contract with local purchasers (health authorities and general practitioner fundholders). Reforms beginning in 1990 moved the NHS away from a centralized administrative structure to more pluralistic arrangements in which competition, as well as management, influences how services develop. Health technology and health technology assessment (HTA) have gained increasing attention in the NHS during this period, as part of a wider NHS Research and Development (R&D) Strategy. Thestrategy promotes a knowledge-based health service with a strong research infrastructure and thecapacity to critically review its own needs. HTA is the largest and most developed of the programswithin the strategy. It has a formal system for setting assessment priorities involving widespreadconsultation within the NHS, and a National Co-ordinating Centre for Health Technology Assessment.The stategy supports related centers such as the U.K. Cochrane Centre and the NHS Centre for Reviewsand Dissemination. A hallmark of the HTA program is strong public participation. The United Kingdomhas made a major commitment to HTA and to seeking effective means of reviewing and disseminating evidence.

The papers on the 16 European countries presented in this issue show their great diversity of health systems. Health technology assessment (HTA) has been institutionalized in a number of members of the European Union and has a growing impact on health policy. A remaining challenge is to see HTA visible and useful at the European level, which requires more active coordination of national and regional activities. A network of HTA programs and researchers has been established. The HTA-Europe Steering Committee has suggested a number of actions by the European Commission to promote further coordination. The most important conclusion of the HTA-Europe report is that a permanent coordinating structure is needed at the European level.

This paper discusses the challenges facing health technologyassessment (HTA) in Europe, based on an explicit analysis of thecharacteristics of an “optimal” HTA system. It has threeobjectives: a) to elaborate an explicit system of policy goals andthe characteristics of an optimal HTA system thatfacilitates the achievement of these goals; b) to identify thegeneral institutional incentive barriers (government and marketfailures) that prevent the attainment of an optimal HTAsystem in Europe; and c) to argue that evaluation of theimplications of health technologies for equity and inequality inhealth is an essential part of this optimal system and aconsiderable challenge for HTA decision makers, especially asnational governments realign policy toward equity goals.

Objectives: To consider the impact of rapid health technologyassessments undertaken as part of a program in a provincial healthcare system in response to urgent requests for advice.

Methods: Review of the development and preparation of 20 rapid assessmentreports, communication with decision makers within the healthcaresystem, and appraisal of data subsequent to preparation of thereports.

Results: Fourteen of the assessments were judged to havehad an influence on policy and other decisions, as judged byresponses from those who had requested advice. Another four wereconsidered to have provided guidance, while having less immediateinfluence on decisions, and two others had no apparent impact.Quality of the assessments was considered acceptable, on the basis ofliterature that subsequently became available and from commentsreceived.

Conclusions: These brief reports are considered to be auseful component of a health technology assessment program. However,they should be regarded as provisional appraisals and followed upwith more detailed evaluation where possible.