Christa Altenstetter

Health Care Reform in Germany: Patchwork Change within Established Governance Structures

Under the pressure of health care reform in the 1990s, interactions among the state, sickness funds, and providers in Germany are said to have entered a new era. We examine this new era by assessing both long-term developments connected to German statutory health insurance (SHI) and related short-term developments of the 1990s. Highly institutionalized rules and practices provide little opportunity for abandoning the historical path of two primary factors: the self-governance of SHI and a strong tradition of a semisovereign state. Some opportunities exist for introducing new ideas, rearranging priorities, softening rules, and adding new complex rules and procedures in a fairly fragmented policy-making system, perhaps even because of fragmentation. Yet reforms that depart from the status quo are severely limited by strong legal and administrative traditions and established rules of the game. These restrictions tend to reinforce state intervention, prevent the emergence of consistent and coherent visions of future health policy, and stifle policy innovation and implementation. In sum, reform measures tend to remain well within the priorities established within state and corporatist governance structures.

Health policy reform, national variations and globalization

List of Tables, Figures and Annexes - List of Acronyms - Globalized Concepts and Localized Practice: Convergence and Divergence in National Health Policy Reforms J.W. Bjorkman & C. Altenstetter - Canadian Health Care Reform and the Politics of Decentralization K. Fierlbeck - The Rise of Managed Care in the United States: Lessons for French Health Policy V.G. Rodwin - The French Health Care System: Inconsistent Regulation J. de Kervasdoue, C. Meyer-Meuret, C. Weill & A. Couffinhal-Colburn - Restructuring Health Care Systems in The Netherlands: The Institutional Heritage of Dutch Health Policy Reforms J.W. Bjorkman & K.G.H. Okma - The Reform of the Health Insurance Systems in the Netherlands and Germany: Dutch Gold and German Silver H. Lieverdink & J.H. van der Made - Health Policy-Making in Germany: Stability and Dynamics C. Altenstetter - Health Care Reform in the Federal Republic of Germany: The New and the Old Lander J. Wasem - Institutions and Ideas into Politics: Health Care Reform in Britain and Germany S. Giaimo & P. Manow - The Politics and Economics of Health Care Reform: Britain in Comparative Context C. Paton - Hiding in the Market Place: Technocracy and Politics in Israeli Health Policy D.P. Chinitz - Politics and Foreign Involvement in Reforming the Health Care Systems of Former Socialist Countries G. Zarkovic & W. Satzinger -State, Economy, and Civil Society Interdependency: Lessons from Polish Health Systems D.M. Duffy - Health Care Systems in Transition in Eastern Europe: The Czech Case M. Beckmann & J. Nemec - Implementation of a Single Health System: New Relationships between the Public and Private Sectors in Brazil A.L. Viana, M.S. Queiroz & N. Iba-ez - Global Health Policy Reform: Misleading Mythology or Learning Opportunity? T.R. Marmor - Consolidated References - Notes on Contributors - Name and Organization Index - Subject Index

EU AND MEMBER STATE MEDICAL DEVICES REGULATION

This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.

An End to a Consensus on Health Care in the Federal Republic of Germany

Over the past fifteen years the national government in the Federal Republic of Germany has animated the political debate about rising health care expenditures. However, it has only provided health policy leadership by shifting the burden of financing health and medical care to others. This paper presents three cases that illustrate the political and institutional constraints inherent in the German policy process that limit the proposal and implementation of appropriate policy solutions to rising health care costs. Cost controls have been inhibited because of the near-universal entitlement of national health insurance, the access all social groups have to advanced medical care, and policies targeted at providers rather than users of health services. The paper also underscores the past and future importance of regional policy coalitions in shaping national health policy.

Medical device regulation in the European Union, Japan and the United States. Commonalities, differences and challenges

The evolution and diversity of institutions across the United States, the EU and Japan, and the timing of the medical device framework splitting off from the drug regulatory framework, are striking. Regulatory agencies face a new landscape: the combination of industry-paid user fees and appropriations, and a general pro-business climate coupled with dramatic advances in medical technology, shortage in skilled experts trained in the latest state-of-the-art science, and necessary legal and administrative changes. This paper seeks explanations for the complex structure of medical device regulation by focusing on the meaning of the “life cycle” concept, opportunities for patient voices, and the scope of, and potential for conflicts of interest of, industry, physicians, scientific advisors and regulatory authorities. The paper concludes that the initial international differences between medical device frameworks tend to be mitigated by voluntary global harmonization, but that actual, effective integration into the national regulatory framework significantly depends on each nations and the EUs embedded norms, rules and procedures, and politics.

Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking

Balancing acceptable risks and early release of products for new treatments in patient care with the rights of patients and the rights of stakeholders—device makers and regulators—is a complex task. With the rapid technological innovations of the last two decades, providing a balanced voice to all participants is essential, but a sense of urgency depends on which side of the aisle one is sitting: on the side of patients, surgeons, regulators, and device makers; or that of providers and scientific advisors. A review of the medical device political economy suggests why patient safety concerns are or should be kept alive throughout the entire regulatory cycle from clinical evaluation and premarket checks to their final use in a huge variety of clinical settings around the globe. The key issue for nano-enhanced devices now is whether the uncertainties and perceived risks can be reduced through more stringent regulatory requirements and proactive measures without stifling innovation and development of new treatments for patients.

European union responses to AIDS/HIV and policy networks in the pre‐Maastricht era

Abstract The study of European public policy is attracting increasing attention. This article reviews the role which European Union‐wide networks have played in translating knowledge, experience and practices into a European Union Policy on AIDS/HIV in the pre‐Maastricht era. The article found three distinct types of network which have emerged in response to a variety of activities: macro‐policy development networks, research networks and community‐based networks. The weight of the evidence supports the argument that a distinctly ‘European policy style’ is emerging but it is not what one would expect from the literature on European integration, interest group politics or comparative politics or from some models of national policy‐making.

Health Policy Regimes and the Single European Market

I examine the potential effects of the creation of a single European market on the health policy regimes of the twelve member states of the European Community (EC), arguing that few changes can be expected in the basic nature of those regimes and that a Community-wide health policy regime is unlikely to emerge in the near future. Domestic health policy regimes and care systems will remain the dominant approach to health care delivery, and it is not likely that the American approach will be adopted. However, EC legislation designed to create favorable trade, economic, and fiscal conditions may affect key industries like pharmaceuticals and health insurance, with consequences for national health policy regimes. Patterns in Community-wide policy-making suggest that it will become increasingly difficult to define health issues in purely domestic or international terms.

Policy, Politics, and Child Health: Four Decades of Federal Initiative and State Response

This paper analyzes the continuity and change in the relationship between federal and state governments in the formation and implementation of child-health programs. After reviewing developments in federal child-health policy since the Sheppard-Towner Act of 1923, methods of implementation and changes in state laws and administrative organization in Vermont and Connecticut are compared with a focus on the major programs authorized by Title V of the Social Security Act. Four broad interactive areas of comparison--governmental relations, program delivery systems, expenditure patterns, and private interests--serve as vantage points for exploring, understanding and explaining the process of policy implementation. Specific conclusions are drawn regarding each area and the overall conclusion is that federal efforts under Title V have not lessened the general neglect of child health in state legislation; nor have they greatly expanded the volume of direct services for child care. They have been sufficiently ambiguous and diffuse to leave the providers dominant, treating diseases and existing conditions rather than focusing energy on preventive measures. Federal resources have been absorbed by expanding administrative overhead, state bureaucracies have been inflated rather than motivated.

Reviewing Health Care Systems@@@Comparative Health Policy and the New Right: From Rhetoric to Reality

Liberalism in the Dirigiste state - a changing public/private mix in French medical care, Paul Godt health policy and the Christian-liberal coalition in West Germany - the conflicts over the health insurance reform, 1987-1988, Douglas Webber privatization from within - the National Health Service under Thatcher, Wendy Renade and Stuart C.Haywood Nordic health policy in the 1980s, Richard B.Saltman health care policy in Eastern Europe - regulatory conservativism under socialism?, William A.Welsh heart disease in Israel - curative or preventive policy?, Yael Yishai two streams of conservativism under the Reagan administration, William P.Brendon health policy under conservative governments in Canada, Prenlal Manga and Geoffrey R.Weller health policies in the Conservative transition to democracy in Brazil, Sonia Maria Fleury Teixeira medical care security and the vitality of the private sector in Japan, William E.Steelicke grains among the Chaff-Rhetoric and reality in comparative health policy, James W.Bjorkman.