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(1998). Israeli environmental policy in comparative perspective. Israel Affairs: Vol. 5, Israel: The Dyanamics of Change and Continuity, pp. 246-264.

Drugs have long been among the most extensively regulated of all consumer products. Not only do all governments closely supervise virtually every aspect of their development, testing, production and marketing, but many also regulate their pricing and distribution. The pharmaceutical industry is highly globalized, with over half the sales of the fifty largest drug companies made outside their home country (Tarabusi and Vivkery 1993). However, until recently, drug regulation was virtually synonymous with national sovereignty. Firms were required to conduct separate tests, submit separate applications, and meet distinctive criteria to enter each national market. Because drugs are so extensively regulated and have such significant health and safety impacts, drug policy coordination has proven extremely difficult. Nonetheless over the last decade, national regulatory agencies have begun to cooperate more closely with one another. The European Union has established a centralized drug approval system, the United States Food and Drug Administration has become more willing to cooperate with its foreign counterparts, and the United States, the EU and Japan have made substantial progress in harmonizing drug approval requirements under the auspices of a new international body, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products (ICH). This article describes and assesses the implications of the increase in international coordination of national drug approval policies. It argues that the undermining of national regulatory sovereignty has improved both the effectiveness and efficiency of government regulation.

This article explores the adequacy of international governance mechanisms to address environmental issues. It examines the impact of increased global economic integration on national and regional environmental standards, the role of market mechanisms in facilitating the dissemination of environmental standards from greener nations to less green ones and the impact of international agreements on trans-border environmental problems. It argues that current regional and international governance mechanisms are adequate to enable nations which have the resources and the commitment to improve environmental quality to do so, either on their own or in cooperation with other nations with similar values and resources. Fears about a 'Delaware effect' regulatory race to the bottom are unwarranted: competition from nations with weaker environmental regulations has not prevented richer, greener nations - where the majority of world production occurs - from strengthening their own regulatory standards. On the contrary, t...

Introduction This article explores ten environmentally related trade disputes that have arisen between the United States and Canada since the implementation of the Free Trade Agreement in 1989. They fall into three broad categories: conservation regulations, recycling policies, and industrial goods and processes. Six of the disputes involve complaints by the United States against Canada and four involve Canadian allegations. We are interested in finding out if the use of environmental regulations can become nontariff barriers to trade. These ten cases reveal the broad range of regional and national environmental regulations that have become the focus of trade conflicts between these two countries. Virtually every environmental regulation affects the relative costs and opportunities of producers. For such a regulation to have an impact on the rules governing trade, three additional factors are required. First, one or more of the producers adversely affected by the regulation must be located in another country. Second, those producers must turn to the political system to apply pressure to challenge the regulation which adversely affects them. Third, the aggrieved producers must claim that the foreign regulation which adversely affects them violates the terms of an international trade agreement or treaty. The existence of a foreign, politically mobilized stakeholder transforms a national or regional regulatory standard or policy into a trade issue. But while every regulation which is challenged as an alleged nontariff barrier clearly disadvantages foreign producers, this may or may not be the reason why it was adopted. In some cases, there may be little or no gain to domestic producers while, in others, pressures from domestic producers may be the primary reason why the regulation was approved. However, the fact that a regulation confers a competitive advantage on a domestic producer does not by itself demonstrate that this domestic regulation is illegitimate, as it may nonetheless serve a legitimate public purpose. In fact, many trade disputes may stem from differences in national regulatory priorities and policies. Distinguishing between legitimate and inappropriate regulations that disadvantage foreign producers, therefore, is an important and ongoing challenge for governments which have entered into agreements to liberalize trade. In this article we analyze each of the ten cases by looking for what has been called a "baptist-bootlegger" coalition. (1) During the U.S. prohibition era, Baptists were opposed to alcoholic consumption on moral grounds, while bootleggers actually benefitted from prohibition by the production and sale of illegal alcoholic beverages. Similarly, today there is often a coalition formed between domestic environmental groups in favor of environmental regulations on public good grounds and domestic producers who recognize an opportunity to erect entry barriers against rival foreign producers. The latter trade barriers occur only when the environmental regulations are administered in a discriminatory manner; that is, by an effective denial of the national treatment provisions which are available to most traders under the North American Free Trade Agreement. (2) National treatment can be denied directly by, for example, a regulation which expressly treats a foreign producer differently than a domestic producer. More subtle, however, are those regulations which appear to be nondiscriminatory but which, in effect, operate in a discriminatory manner against foreign producers. These are the focus of the case studies. In all but one of the following ten cases examined we find evidence of bootleggers. 1. Prohibition of Imports of Tuna and Tuna Products from Canada (GATT, 1982) In 1979, Canada seized nineteen U.S. tuna boats fishing inside Canada's 200-mile fisheries zone. (3) The United States, acting under the 1976 Fishery Conservation and Management Act, retaliated by prohibiting the entry of all tuna and tuna products from Canada. …

This article reviews the literature on business-government-society relations during the past three decades. It describes the growth of scholarship on business power, business political activity, the changing political agenda, interest group representation, and changing social expectations and explores in detail three approaches to the study of the political and social role of business: a comparative perspective, an emphasis on the contemporary political and social environment of business, and an exploration of the nature of business power. While we have clearly learned much about this important subject, the intellectual fragmentation of this field prevents it from realizing its full scholarly potential.

Corporate social responsibility (CSR) is increasingly being recognized by firms as central to core business activities, as opposed to a peripheral consideration largely associated with philanthropy. This trend has major ramifications for marketing strategy that were explored at an international conference on “Integrating Social Responsibility and Marketing Strategy” held at the Boston University School of Management in September 2003. The conference was co-chaired by C.B. Bhattacharya of Boston University and N. Craig Smith of London Business School and sponsored by the Aspen Institute’s Business and Society Program; Boston University School of Management; London Business School; the Marketing Science Institute; and the California Management Review and the Center for Responsible Business at the Haas School of Business at the University of California, Berkeley.This Special Issue of California Management Review on “Integrating SocialResponsibility and Marketing Strategy, edited by C.B. Bhattacharya, N. Craig Smith, and David Vogel, contains a subset of the papers presented at the conference following a process of peer review. In the first article, “Doing Better at Doing Good,” based on their ongoing consumer research in this domain, Bhattacharya and Sen propose a contingent, detailed model of when, why, and how consumers respond to CSR initiatives. A key insight from their model is that in addition to the sponsoring company, the participating consumers and the issue/cause also benefit from social initiatives. A broad perspective is also offered by Waddock and Bodwell in the second article, “Managing Responsibility.” The authors identify parallels with the total quality movement and propose total responsibility management as an appropriate response to pressures today for increased corporate attention to CSR.

En este artículo primero se presenta el análisis de la representación, para ofrecer una base para la definición de la narrativa como una forma de representación en la cual los hechos se organizan en secuencias significativas. Después de una explicación y comparación de las posiciones en el uso de la narrativa adoptadas por Efran y Niemeyer, se presenta una tercera orientación constructivista más radical de la narrativa en psicología. Esta orientación se basa en el concepto de perspectiva incongruente, un concepto crítico en el análisis del cambio conceptual en muchas áreas, incluyendo la psicoterapia. El desarrollo del concepto de la narrativa en la psicología constructivista se puede fomentar a través de una combinación del análisis de narrativas discretas y una perspectiva narrativa que dirige toda mente humana.

This book examines the politics of consumer and environmental risk regulation in the United States and Europe over the last five decades, explaining why America and Europe have often regulated a wide range of similar risks differently. It finds that between 1960 and 1990, American health, safety, and environmental regulations were more stringent, risk averse, comprehensive, and innovative than those adopted in Europe. But since around 1990 global regulatory leadership has shifted to Europe. What explains this striking reversal? This book takes an in-depth, comparative look at European and American policies toward a range of consumer and environmental risks, including vehicle air pollution, ozone depletion, climate change, beef and milk hormones, genetically modified agriculture, antibiotics in animal feed, pesticides, cosmetic safety, and hazardous substances in electronic products. The book traces how concerns over such risks—and pressure on political leaders to do something about them—have risen among the European public but declined among Americans. The book explores how policymakers in Europe have grown supportive of more stringent regulations while those in the United States have become sharply polarized along partisan lines. And as European policymakers have grown more willing to regulate risks on precautionary grounds, increasingly skeptical American policymakers have called for higher levels of scientific certainty before imposing additional regulatory controls on business.

This chapter explores some of the broader implications of studying the dynamics of policy convergence and divergence, the relationship between political institutions and policy styles, and the public perception of risks. The extensive literature on policy convergence addresses two issues: the extent of policy convergence and direction of policy convergence. A second body of literature addresses the impact of convergence on the direction of public policy. Much of this literature focuses on the impact of increased economic integration and global competition on the stringency of environmental regulation. The fact that both the United States and the EU have adopted a wide range of comprehensive consumer and environmental regulations suggests that powerful political and economic states enjoy substantial discretion in responding to domestic pressures for more stringent consumer and environmental regulations.

This chapter analyzes European and American policies toward a range of consumer safety risks; including drugs, children's products, and cosmetics. It shows how European and American risk regulations have converged, though the dynamics through which this occurred differed substantially. Pharmaceutical regulation constitutes the most important exception to the broader pattern of increased transatlantic regulatory policy divergence. What makes this area of regulatory policy distinctive is that its political salience increased in the United States but not in Europe. Pharmaceutical regulation also represents an important exception to the dominant pattern of transatlantic regulatory policy diffusion. In this case, European regulatory policies did affect those of the United States, first by highlighting the transatlantic drug lag, and more recently by American decisions to adopt some European practices to expedite drug approvals.

This chapter explores changes in public opinion regarding the transatlantic politics of risk regulation, as well as the preferences of influential policy makers. Both separately and by their interaction with one another, they have had a critical impact on shaping the divergence in transatlantic regulatory stringency. The chapter presents a broad historical overview of changes in public demands for more stringent risk regulations and the willingness of policy makers to address them. During the second half of the 1980s, the extent and intensity of public concerns about a wide range of health, safety, and environmental risks increased substantially on both sides of the Atlantic. These concerns played a role in a major expansion of consumer and environmental regulation in both the EU and the United States.

This chapter compares regulations that address the risks of air pollution—one of the most critical dimensions of environmental regulation. It specifically examines the policies in the United States and Europe and their decisions toward the health and environmental risks of mobile (vehicular) source pollutants, ozone-depleting chemicals, and global climate change. The politics of global climate change reveals a very divergent pattern. In this case, the preferences of American policy makers were more polarized than in Europe. American public policies toward the risks of global climate change have been significantly affected by partisan differences, which increased substantially during the 1990s. By contrast, European policies toward global climate change have been much less affected by differences in the political preferences of center-left and center-right policy makers.

This chapter explores several alternative explanations for the divergence in transatlantic risk regulation, and discusses the policy shifts that have taken place on both sides of the Atlantic since around 1990. The United States and the fifteen member states of the EU are affluent democracies with sophisticated public bureaucracies, substantial scientific capacities, and strong civic cultures. Their regulatory officials have access to much of the same scientific expertise and there is extensive communication among policy makers, scientists, business managers, nongovernment organizations, and citizens. The chapter shows how divergent risk regulations between the United States and the EU add to the costs of transatlantic commerce and also raise the costs of international trade as some countries adopt European standards and others adopt American ones.

This chapter looks at American and European policies toward the risks of chemicals and hazardous substances. The 1976 Toxic Substances Control Act (TSCA) significantly strengthened American chemical regulations and contributed to the 1979 decision of the EU to both harmonize and strengthen its chemical regulations, though they remained weaker than those of the United States. While there has been no major statutory change in American chemical regulation since then, in 2006 the EU approved REACH—the Registration, Evaluation, Authorization and Restriction of Chemicals, which made European chemical regulations significantly more stringent and comprehensive than those of the United States. Meanwhile, risk assessments by the U.S. federal government do not consider the hazardous substances in electronics deposited in landfills as a threat to public health.

This chapter focuses on European and American policies toward the risks of food safety and agricultural production methods. A number of food safety regulations were affected by a divergence in transatlantic public risk perceptions. During the 1960s, 1970s, and 1980s, public concerns about the risks of carcinogens in the food supply were greater in the United States than in Europe, while during the 1980s, the safety risks of beef hormones became highly salient in Europe, but not in the United States. In addition, the criteria used by policy makers in both the United States and Europe to assess and manage risks shifted: American regulatory officials placed increased reliance on scientific risk assessments, while European policy makers began to employ a more precautionary approach to food safety risks.

This chapter describes how and explains why American regulatory policies have moved away from and European policies moved toward a precautionary approach to assessing and managing risks. It begins by documenting the precautionary basis of many of the risk regulations adopted by the United States, primarily before 1990, providing further evidence that there is nothing distinctively “European” about a precautionary approach to risk regulation. It then turns to the increasingly important role of regulatory impact analyses in the United States, which include both scientific risk assessments and cost–benefit analyses. The United States also experienced an influential backlash that questioned the rationale behind many of the highly risk-averse regulations it had previously adopted, claiming that many were false positive policy errors.

This chapter describes how the United States (US) and the European Union (EU) are federal systems in which the responsibility for environmental policy-making is divided or shared between the central government and the (member) states. The attribution of decision-making power has important policy implications. This chapter compares the role of central and local authorities in the US and the EU in formulating environmental regulations in three areas: (1) automotive emissions; (2) packaging waste; and (3) global climate change. Automotive emissions are relatively centralized in both political systems. In the case of packaging waste and global climate change, regulatory policy-making is shared in the EU, but is primarily the responsibility of local governments in the US. Thus, in some important areas, regulatory policy-making is relatively centralized in the EU. The most important role local governments play in the regulatory process is to help diffuse stringent local standards through centralized regulations, a dynamic which has become more common in the EU than in the US.

A constructivist analysis of representation is first offered, to provide a basis for a definition of narrative as a form of representation in which events are organized in meaningful sequence. After an explication and comparison of the positions on the use of narrative taken by Efran and Neimeyer, a third, more radical constructivist orientation to narrative in psychology is presented. This orientation is based on the concept of perspective by incongruity, a concept critical to the analysis of conceptual change in many arenas, including psychotherapy. The development of the narrative concept in constructivist psychology can be furthered through a combination of the disciplined analysis of discrete narratives and a more sweeping narrative perspective that addresses all human mentation.

This well-documented book analyzes the possibilities and constraints of regulatory cooperation between the EU and the US (particularly California) with a specific focus on environmental protection, food safety and agriculture, biosafety and biodiversity.

This article describes and compares the politics of tobacco regulation in four industrial democracies: the US, Canada, France, and Japan. We argue that the degree and type of cigarette control has varied among these countries and that these contrasts reflect different political and cultural traditions concerning in dividual rights and the proper role of government, as well as differences in government structure. The US is widely regarded as having a highly individu alistic culture, suspicious of government control over civil society. In contrast, Japan is a hierarchical society, in which individual preferences are generally sub ordinated to group needs and state auth ority. France resembles Japan in its elitist decision-making and low level of group participation, but also differs in that it does not pursue social consensus or de value individualism. Canada, like the US, is characterised by more group particip ation than France or Japan, but is more willing than the US to let government define and pursue collective goals. These factors have played a major role in determining the scope and target of tobacco controls implemented in each country. We identify three types of tobacco regulation: informational, pat ernalistic, and protective. Because the four countries have such different con ceptions as to what constitutes the appropriate scope of governmental authority and responsibility, there is sig nificant variation in the types of tobacco control they have adopted. {Tobacco Control 1993; 2: 317-26)

What is unique about the development of business ethics in the USA, and how does it compare with various countries of Europe and with Japan? Institutional, legal, social and cultural factors are identified by the Professor of Business and Public Policy at the Haas School of Business, University of California at Berkeley. An earlier version of this article titled “The Globalization of Business Ethics: Why America Remains Distinctive” was published in the Fall 1992 issue of the California Management Review, Vol. 35, No. 1. Reprinted by Permission of The Regents of the University of California.

Corporate responsibility has gone global. Business leaders, as well as leaders from government and civil society, increasingly argue that business must play a constructive role in addressing massive global challenges. Business is not responsible for causing most of the problems associated with, for example, extreme poverty and hunger, child mortality and HIV/AIDS – and, arguably, it is only indirectly responsible for most of the problems of climate change. However, it is often claimed that business has a responsibility to help ameliorate many of these problems and, indeed, it may be the only institution capable of effectively addressing some of them. As a result, corporate responsibility has secured the attention of business leaders, governments and NGOs to an unprecedented extent. Thus this book, Global Challenges in Responsible Business – which originated in an international conference on corporate responsibility organized at London Business School – addresses the implications for business of corporate responsibility in the context of globalization and the social and environmental problems faced by global business today. The book offers a rich set of articles reflective of research on corporate responsibility, many of which are informed by empirical studies. It focuses on three key corporate responsibility issues for global business: embedding corporate responsibility within the organization, the relationship between corporate responsibility and marketing, and implementing corporate responsibility in developing countries.

This article explores the political dynamics of new forms of transnational non-state governance designed to make global firms more responsible and accountable. It begins by defining “civil regulation,” describing its growth and placing its development, structure, and purposes in a broader historical and institutional context. It then explains the development of civil regulation as a response to the shortcomings of the global and national governance of global firms and markets. The third section describes how various policy entrepreneurs, led by non-governmental organizations (NGOs) and often supported by some national governments and international organizations, have, through a complex process of conflict and cooperation, persuaded large numbers of global firms to accept non-state regulatory standards.

During the last decade, highly publicized incidents of business misconduct have occurred in virtually every major industrial economy. These scandals have played a critical role in increasing public, business, and academic awareness of issues of business ethics throughout the United States, Europe, and Asia. Yet the extent of both public and academic interest in business ethics remains substantially greater in the United States than in any other capitalist nation. Moreover, the way Americans approach ethical issues remains distinctive. This article shows how the distinctive institutional, legal, social, and cultural context of American society has affected the way Americans perceive the ethical dimensions of business.

This article examines the role of governments and civil society in shaping and encouraging corporate social responsibility (CSR). It begins by exploring the relationship between CSR and particular patterns of business–government–civil society relations. It then examines the patterns of business–government relations that are associated with CSR. It explores two basic models. One is the dichotomous view that posits that CSR and government are, by definition, mutually exclusive; accordingly, the scope of CSR is defined by the absence of regulation and public policy. The second posits that CSR is the relationship between market actors and governments. This article also investigates changes in business–government–civil society relations which explain the recent growth and development of CSR. Finally, it examines the ways in which governments have promoted CSR and the relationship between responsible public and private policies.

This article traces the historical roots of some of our current preoccupations with the ethics of business. It argues that many of the contemporary criteria that we use to evaluate the ethics of business are not new; rather, they date back several centuries. This argument is illustrated by comparing historical and contemporary discussions of three sets of issues: the relationship between ethics and profits, the relationship between private gain and the public good, and the tension between the results of capitalism and the intentions of businessmen. The fact that these tensions are inherent in the nature of capitalism, if not human nature itself, does not make our contemporary concerns or standards any less valid. On the contrary, it underlies their significance. Contemporary discussions of business ethics constitute part of an ongoing moral dialogue with both deep secular and religious roots.

This paper traces the historical roots of some of our current preoccupations with the ethics of business. Its central argument is that many of the contemporary criteria that we use to evaluate the ethics of business are not new; rather, they date back several centuries. This paper illustrates this thesis by comparing historical and contemporary discussions of three sets of issues: the relationship between ethics and profits, the relationship between private gain and the public good and the tension between the results of capitalism and the intentions of businessmen.The fact that these tensions are inherent in the nature of capitalism, if not in human nature itself, does not make our contemporary concerns or standards any less valid. On the contrary, it underlies their significance. Contemporary discussions of business ethics constitute part of an ongoing moral dialogue with both deep secular and religious roots.

This article examines a neglected phenomenon in the existing literature on social regulation, namely political opposition to regulation that comes not from business but from consumers. It examines four cases of successful grass-roots consumer opposition to government health and safety regulations in the United States. Two involve rules issued by the National Highway Traffic Safety Administration, a 1974 requirement that all new automobiles be equipped with an engine-interlock system, and a 1967 rule that denied federal highway funds to states that did not require motorcyclists to wear a helmet. In 1977, Congress overturned the Food and Drug Administration's ban on the artificial sweetener, saccharin. Beginning in 1987, the FDA began to yield to pressures from the gay community by agreeing to streamline its procedures for the testing and approval of new drugs designed to fight AIDS and other fatal diseases. The article identifies what these regulations have in common and examines their significance for our understanding the politics of social regulation in the United States and other industrial nations.

A therapeutic antibody candidate (AT-19) isolated using multivalent phage display binds native tomoregulin (TR) as a mul-timer not as a monomer. This report raises the importance of screening and selecting phage antibodies on native antigen and reemphasizes the possibility that potentially valuable antibodies are discarded when a monomeric phage display system is used for screening. A detailed live cell panning selection and screening method to isolate multivalently active antibodies is described. AT-19 is a fully human antibody recognizing the cell surface protein TR, a proposed prostate cancer target for therapeutic antibody internalization. AT-19 was isolated from a multivalent single-chain variable fragment (scFv) antibody library rescued with hyperphage. The required multivalency for isolation of AT-19 is supported by fluorescence activated cell sorting data demonstrating binding of the multivalent AT-19 phage particles at high phage concentrations and failure of monovalent particles to bind. Pure monomeric scFv AT-19 does not bind native receptor on cells, whereas dimeric scFv or immunoglobulin G binds with nanomolar affinity. The isolation of AT-19 antibody with obligate bivalent binding activity to native TR is attributed to the use of a multivalent display of scFv on phage and the method for selecting and screening by alternate use of 2 recombinant cell lines.

Hepsin is a type II transmembrane serine protease that is expressed in normal liver, and at lower levels in kidney, pancreas, and testis. Several studies have shown that hepsin mRNA is significantly elevated in most prostate tumors, as well as a significant fraction of ovarian and renal cell carcinomas and hepatomas. Although the overexpression of mRNA in these tumors has been extensively documented, there has been conflicting literature on whether hepsin plays a role in tumor cell growth and progression. Early literature implied a role for hepsin in human tumor cell proliferation, whereas recent studies with a transgenic mouse model for prostate cancer support a role for hepsin in tumor progression and metastases. To evaluate this issue further, we have expressed an activatable form of hepsin, and have generated a set of monoclonal antibodies that neutralize enzyme activity. The neutralizing antibodies inhibit hepsin enzymatic activity in biochemical and cell-based assays. Selected neutralizing and nonneutralizing antibodies were used in cell-based assays with tumor cells to evaluate the effect of antibodies on tumor cell growth and invasion. Neutralizing antibodies failed to inhibit the growth of prostate, ovarian, and hepatoma cell lines in culture. However, potent inhibitory effects of the antibodies were seen on invasion of ovarian and prostate cells in transwell-based invasion assays. These results support a role for hepsin in tumor cell progression but not in primary tumor growth. Consistent with this, immunohistochemical experiments with a mouse monoclonal antibody reveal progressively increased staining of prostate tumors with advanced disease, and in particular, extensive staining of bone metastatic lesions. (Cancer Res 2006; 66(7): 3611-9)