混合型监管：政策工具视野下的中国药品安全监管

在当代中国,社会性监管正在被越来越多地运用到公共卫生、生产安全和环境保护等公共治理过程.以药品安全监管为个案,结合西方社会性监管的有关理论,从建章立制、设立标准、建立奖惩机制以及优化执行系统四个政策工具角度,对当代中国药品安全监管的政策过程进行分析,结果表明,由于受到社会治理模式转型的影响,中国药品安全监管模式可以被界定为"混合型监管".一方面,中国的药品安全监管政策在形式上已经具有了一些现代监管型政府的特点,例如建章立制、设立标准,并综合运用经济、法律和行政等手段;另一方面,却在许多方面仍然带有许多前监管型政府特征,而这些特征大都是计划经济时代的产物.虽然监管型政府正在逐渐取代全能型政府而成为未来中国政府可能的治理模式,但是从政策分析的角度来看,监管型政府的建设在中国并不是一蹴而就的.建设一个高效的现代监管型政府,仍然是市场经济时代下中国国家政权建设过程中的重要目标.     

EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective

This paper provides a comparison of European Union regulatory policy for pharmaceuticals and medical devices. The discussion highlights key similarities and differences in regulatory approach for the two sectors. More importantly, it explores the balance that has been struck between public health, health care, and industrial policy as “competing” objectives within the respective regulatory regimes. It is argued that, despite both sectors being affected by the same institutional rules and constraints at the EU level, and both being central to the delivery of high-quality health care in Europe, there are a surprising number of differences between the regulatory frameworks. That this stems in part from their different “launch” times, hence different institutional conditions of regulation, and commensurate political climates, as well as reflecting different aims and goals among member-state and EU-level policy makers, are among the paper's main conclusions.     

Regulation for Safe Food: A Comparison of Five European Countries

This article explores food safety regulation in five European countries by comparing their main legislation and organizational characteristics. The aim is to gain insight into the particular characteristics of food safety regulation, understand major differences and similarities, and reach a firmer understanding of how regulation evolves. Food safety regulation concerns vital questions, and is a field with a long history. Food scandals – in particular the 1996 BSE crisis – and European integration have prompted major changes. The BSE scandal revealed important underlying conflicts of interest and dilemmas concerning the twin objectives of ensuring safe food while also ensuring honest trade in food. This led to a questioning of existing structures and paved the way for new regulation. The authors' main finding is that food safety regulation has similar origins, addresses similar tasks, and raises similar problems and conflicts in all five countries. A tension between protecting public health and paying heed to business interests, and a struggle for control over this policy field between the administrations of health and agriculture, are common features. However, the configuration of food safety regulation in legislative and organizational terms varies. The comparative focus reveals that national context and history are important for understanding change. This leads to the conclusion that the framing and reframing of the field depend largely on how it is structured and regulated initially, as well as on the constellations of interests and values that are operative and legitimate in each context.     

Deregulation and Participation: An International Survey of Participation in Electricity Regulation

Amidst the wave of privatization and "deregulation" across the globe, a new set of regulatory structures is being created. The fact that deregulation actually involves "re-regulation" has been acknowledged in the recent literature, but the tension between regulation and public participation has been understudied in these new structures. While some private markets need effective regulation to reduce transactions costs and ensure stable market rules, consumers need regulation that is responsive to, and protective of, their interests. Consumer participation, therefore, is an important component of effective regulation. Effective regulation must also consider collective national or public interests, including the well-being of corporations. Therefore, regulatory agencies need to be both independent from, and responsive to corporate, consumer, and public interests. This article will briefly examine the tension among the competing goals of regulatory independence and responsiveness, and then conduct a broad survey of the status quo of public participation in national regulatory structures for electricity in the Americas. Our case studies demonstrate a wide variety of institutional mechanisms for participation, yet we find that no existing system seems to embrace direct participation by a wide set of consumers. The problems are even more acute in developing countries. We conclude by looking at recent experiments and proposals to improve the levels of participation in regulatory decision making.     

The Globalization of Pharmaceutical Regulation

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.     

Managing Risk and Regulation in European Food Safety Governance

This article focuses on the state of European food safety governance and offers a view on possible future courses of regulatory policymaking. We begin by examining the deficiencies of the current multilevel governance system in European Union (EU) food safety policy, with an empirical focus on Hazard Analysis and Critical Control Point (HACCP) systems. We then submit that a regulatory agency model (centralization) might perform better than multilevel governance or renationalization in terms of reducing business uncertainty, promoting food safety enhancing innovation, and improving consumer trust in the food supply. Hence it would make European food markets more resilient to recurrent food safety crises. We also argue that the EU's precautionary approach as applied to some areas of food safety risks is tied to legitimacy enhancing objectives of EU institutional actors. Assuming that supply‐side rents will change over time, we submit that emphasis of regulatory impact analysis (i.e., cost benefit considerations) is likely to increase.     

Regulation and evasion: Street-vendors in Manila

There are various reasons why the often stated gap between policy formulation and policy implementation is especially large in developing countries: ambiguous policy goals, decision-making without considering the needs of those affected, low degree of compliance and administrative capacity of implementing agencies etc What is perhaps most striking is the fact that interest aggregation generally occurs at the enforcement stage only. This means that laws and regulations can be sapped and distorted along the lines of the power constellations of the actors involved. The case study presented here deals with the regulatory aspects of street-vending in the particular cultural environment of a South-East Asian capital, Manila. It is demonstrated that regulations are more inspired by Western images of modernization largely removed from the harsh socioeconomic realities of the sector.Moreover, compliance is minimized by cultural values (conflict avoidance, respect of power structures) governing the behavior of lower level administrative agents and hawkers alike. The overall result is that regulations are purely symbolic and ineffective, nevertheless maintaining a climate of harassment and extortion.The paper advocates a more positive approach towards street-vendors combining minimal regulation with measures of encouragement and public assistance.     

India,Brazil, and public health: Rule-making through south–south diffusion in the intellectual property rights regime?

This article analyzes the domestic drivers of regulatory state formation in India and Brazil and its consequences for the global rules governing pharmaceutical patents. We first analyze Indian and Brazilian politics of regulatory state formation; then, in light of the extent to which the two countries have built regulatory capacity and capability in the field of patent regulation, we explore whether and how they have been able to influence the existing intellectual property regime in health. We look into India's Section 3(d) and Brazil's prior consent requirement. Whereas India's Section 3(d) regulation has gained international regulatory influence by diffusing to other developing countries, the same cannot be said for Brazil's prior consent regulation, which has been caught by policy-reversals. The transition toward regulatory states in emerging countries is a bulky road and does not progress in linear ways. However, once regulatory capacity and capability have been solidified, domestic policy innovations can become internationally influential.     

产品质量安全监管体制的国际比较与启示

产品质量问题关系到社会公众的人身与财产安全,对于企业、消费者乃至整个社会都是一个不容回避的问题,发达国家经过长期积淀形成了较为严格与稳定的产品质量安全监管体制,并呈现日渐完善趋势。美国、欧盟与日本等在产品质量安全监管的法律法规、机构设置、技术支撑等方面具有较为成熟的经验与措施,而我国存在产品质量安全法律法规体系不够系统、多部门监管、权责利分配不到位、认证标准体系缺失与滞后等问题。完善我国的产品质量监管,要树立一体化规范制定理念,确保法律体系系统化;整合梳理监管机构职能,促进监管资源的有效配置;引入成熟经验成果,鼓励监管措施多样化。     

It runs in the family: Meta-regulation and its siblings

Regulators in different countries and domains experiment with regulatory tools that allow organizations to adapt regulation to their individual circumstances, while holding them accountable for their self-regulation systems. Several labels have been coined for this type of regulation, including systems-based regulation, enforced self-regulation, management-based regulation, principles-based regulation, and meta-regulation. In this article, these forms of regulatory governance are classified as belonging to one family of “process-oriented regulation.” Based on a review of diverse empirical and theoretical research, it is suggested that the family of process-oriented regulation tends to have a positive, albeit varied, impact on organizations' performance, and the factors that shape this inconsistent effect are analyzed. Building on aspects of Parker's normative construct of “meta-regulation,” the article explores the extent to which her innovative notion of a learning-oriented approach to regulation might overcome some of the weaknesses of prevalent process-oriented approaches. It is proposed that under conditions of regulatory uncertainty or entrenched and prevalent non-compliance or both, meta-regulation is likely to have many advantages over other forms of process-oriented regulation. Yet realizing these advantages requires a rare combination of high regulatory capacity, a stable regulatory agenda, and a supportive political environment.     

中国食品安全监管——基于体制变迁与绩效评估的实证研究

自新中国成立以来,中国食品安全管理体制经历了一个怎样的历史变化过程?从历史制度分析的方法论出发,如何从监管者、监管对象以及监管过程三个角度来界定这样的历史变化过程?现行的食品安全监管体制绩效如何?根据不同时期食品安全管理主体、对象以及政策工具的差异,将建国以来我国食品安全管理体制区分为指令型体制、混合型体制与监管型体制三个阶段,同时对不同阶段的发展脉络、具体特征以及体制利弊进行了归纳总结。此外,选择了四个具有代表性的指标,对1990年至今的中国食品安全变化态势进行了测量,发现我国食品安全的形势经历了一个明显的V型曲线发展过程,并据此对这一过程提出自己的解释假设,以此为中国食品安全监管的历史和现状提供一个白描式的描述图景。结合历史制度主义的分析范式,从四个方面综合分析出制约中国食品安全监管绩效优化的四大结构性因素,从而将其监管绩效的现状与历史制度根源联系起来,提出未来中国食品安全监管体制的改革方向。     

Introduction: Regulation and Oversight of Digital Campaigning—Problems and Solutions

The regulation of digital technology is gaining increased attention within policy making circles. With growing recognition of the power held by digital media companies and the need to enforce democratic values online, policy makers are reviewing opportunities for oversight. Introducing a special section looking at the regulation of digital election campaigning, this article reviews the case for regulatory reform, the proposed type of regulatory change, and the practice of regulatory innovation. Noting the pace of digital change, it argues that there is a need to think more extensively about the design of any regulatory response in order to prevent systems of oversight becoming obsolete.     

Regulation and Compliance Motivations: Examining Different Approaches

This research examines how traditional regulatory and voluntary approaches affect motivations to address potential harms to water quality. The traditional approach consists of governmental enforcement of mandatory requirements; the voluntary approach consists of government calling attention to potential harms and facilitating actions to address them. These approaches are best thought of as ends of a continuum rather than as the sole choices. Three sets of findings emerge from the research. One, not surprisingly, is that traditional regulation is more effective than the voluntary approach alone. A second shows that deterrent fears and the sense of duty to comply are important motivations for action. A third concerns factors that account for the variation in each motivation for which inspections, peer reputation, and attitudes toward government are shown to be important considerations. These findings point to the duality of deterrent fears and civic obligations as motivations to address potential harms.     

Technocracy,Politicization, and Noninvolvement: Politics of Expertise in the European Regulation of Chemicals

This article addresses the relationship between scientific expertise and policy in European chemicals regulation. We argue that the role of scientific expertise in the European regulation of chemicals varies across decision‐making levels, countries, and stages of the policy process. Our case study of the role of scientific expertise in the regulation of brominated flame retardants illustrates considerably different manifestations of this interconnected process across regulatory arenas, even though this case concerns a single group of substances. On the European Union level, we find a mix of technocracy and politicization; in Sweden, a clear‐cut politicization; and in Poland, noninvolvement. Such differences can be explained by a combination of factors, in particular frame dominance, and mobilization of advocacy coalitions.     

Regulation through titling laws: A case study of occupational regulation

This case study examines a form of occupational regulation infrequently examined in academic literature – titling laws. These laws regulate who may legally use a phrase, or title, to describe their work to the public. Focusing on the interior design industry, this article demonstrates how industry leaders use titling laws as the first step in a push for full occupational licensure. In so doing, they allege a need for regulation out of concern for public health and safety, but as data in this case study indicate, there appears to be no threat to public health and safety from unregulated interior designers. Instead, designers advocate for increased regulation of their own industry, through the evolution of titling laws to full licensure, due to the benefits it affords them.     

The Politics of ‘Third Country Equivalence’ in Post-Crisis Financial Services Regulation in the European Union

After the global financial crisis, the European Union has adopted a new regulatory approach towards foreign countries by making use of equivalence rules in finance. Why? This paper argues that it is the EU’s attempt to restore financial stability in its territory and maintain the competitiveness of its financial industry. However, this ‘old’ dilemma between stability and competition in financial regulation is further complicated in a regional jurisdiction, such as the EU, because different regulatory paradigms play off in the dilemma.     

The Bio-economy and the Competition State: Transcending the Dichotomy between Coordinated and Liberal Market Economies

This article examines the role of the state in the emerging bio-economy. The starting point is that state interventions, including supportive regulatory arrangements and the shaping of public attitudes, constitute core assets in the evolution of bio-industrial complexes. Public policy in the bio-economy, across advanced industrial countries, is well captured by the “competition state” concept. This type of state takes different forms, analogously with the historical variants of the Keynesian welfare state. The article compares patterns of governance of the biotechnology sector in Finland and Sweden, the USA and the UK, and Australia. It is concluded that the bio-industry sector does not fit with the “models of capitalism” paradigm which postulates coherence within, and systemic divergences between, national models of economic governance. The bio-economy displays trends toward convergence, in particular mounting public investments in health care and in research and development. On the other hand, countries differ in their approach to market regulation, industrial support, and ethical restrictions. These differences do not follow the dichotomy between “liberal” and “coordinated” models of capitalism.     

Salt,high blood pressure,and performance‐based regulation

Performance‐based regulation is a new approach to public health promotion. The aim of this article is to explain how this idea might be applied to the public health goal of reducing salt consumption as a way of reducing high blood pressure and thereby saving lives. Performance‐based regulation is compared with competing regulatory strategies.     

Policy and regulatory design for developing countries: a mechanism design and transaction cost approach

The first-generation literature on policy design has made considerable contributions over the last 30 years to our understanding of the process, politics and implications of policy design and instrument choice. This literature, however, has generally treated institutions as a black box and has not developed a coherent set of frameworks, theories and models of how institutions matter to policy design. In this paper, I unpack the black box of institutions using transaction cost and mechanism design to show how regulations can be better designed in developing countries when institutions are weak, unaccountable, corrupted or not credible. Under these conditions, I show that efficient regulatory design has to minimize transaction costs, particularly agency problems, by having incentive compatible (self-enforcing) mechanisms. I conclude with a second-generation research agenda on regulatory design with implications for environmental, food and drug safety, healthcare and financial regulation in developing countries.     

Regulatory inspection and the changing legitimacy of health and safety

The regulation of conduct via law is a key mechanism through which broader social meanings are negotiated and expressed. The use of regulatory tools to bring about desired outcomes reflects existing social and political understandings of institutional legitimacy, the meanings attached to regulation, and the values it seeks to advance. But these contextual understandings are not static, and their evolution poses challenges for regulators, particularly when they reflect political framing processes. This paper shows how inspection has been reshaped as a tool within the United Kingdom's health and safety system by changes in the meanings attached to the concept of “risk‐based regulation.” While rates of inspection have fallen dramatically in recent years, the nature and quality of inspection have also been fundamentally reshaped via an increasingly procedural and economically rational “risk‐based” policy context. This has had consequences for the transformative and symbolic value of inspection as a tool of regulatory practice.