Integrating Environmental Protection and EU Competition Law: Why Competition Isn't Special

One of the biggest challenges facing environmental policy makers at present is that of integrating environmental protection goals into economic policy areas. Unless this is genuinely achieved, it is clear that environmental degradation will continue apace. Though one of the EU's most important areas of economic competence is competition policy, many policy makers and commentators reject the notion that environmental concerns should play a significant role in EU competition analysis. In that light, this article addresses two key questions. First, should this approach apply? Second, if not, what are the principles that govern how environmental protection requirements should be taken into account by decision makers applying EU competition law? In answering these questions, the article puts forward three theoretical arguments as to why, and how, the environmental benefits and damage flowing from goods and services should be taken into account by EU competition decision makers, based, respectively, on legal systematic, governance and economic reasoning.     

专利保护与强制许可

本文简要回顾了强制许可制度在巴黎公约中产生的历史过程和意义,介绍了TRIPS协议对有关强制许可的主要规定和国际上对有关药品专利问题和强制许可问题的关注。本文对中国专利法中的强制许可制度进行了扼要分析,指出强制许可的主要作用是威慑和劝阻,并未与专利的正常利用不合理地冲突,也并未不合理地损害专利所有人的合法利益。     

Beyond Compliance Monitoring: New Strategies for Safety Regulators

Although the advent of general duty legislation makes the task of the regulator far less clear-cut, inspectorates are still involved in monitoring and to some extent enforcing compliance with rules of various sorts. Monitoring compliance in this way is crucially important, but this article seeks to identify strategies that go beyond compliance monitoring, by drawing on research on the causes of accidents and the nature of organizations. The strategies identified include: auditing the auditors; proactive investigation; supporting company safety staff; advising on organizational design; exposing performance; and promoting regulatory crisis. These are all ways in which regulators can encourage companies to improve their management of risk, ways that are not focused on identifying noncompliance with rules of any sort.     

权利限制与权利保障——对行政许可制度的再认识

行政许可制度的性质可以从两个方面加以理解 :从表现形式看 ,是对相对人任意行使权利的一种法律限制 ;从实质内容看 ,是对相对人权利的保障。行政许可行为具有连续性和过程性 ,这是它与行政确认的最重要的区别     

《行政许可法》的实施与环境行政许可制度的加强

《行政许可法》的实施在客观上造成了行政许可范围的缩小,但却没有引起环境行政许可事项的减少。我国现行的环境行政许可包括5类30余项。不管是因为应对日益严重的环境问题而发挥国家行政机关的作用,还是为利用行政许可制度的长处,克服现行法律的缺陷,我国都应进一步加强环境行政许可。     

超越惩罚:环境法律责任的体系重整

环境问题的发展客观上导致了环境法律责任理论和实践对惩罚的过分倚重,当前,环境民事责任、行政责任和刑事责任都有明显加重惩罚的倾向。但是,重罚思路并未取得预期的环境保护效果,在理论上也缺乏逻辑基础且背离主流导向,需要及时矫正以避免制度失败和导致社会不公。应当全面认识法律责任的惩罚、补偿和预防功能,承认惩罚性责任在环境法律实施中的基础性作用,同时认清其局限性;准确认识补偿性责任在环境法中的实现方式和作用空间,以及预防性环境法律责任的有限性及必要性。进而,以环境保护秩序维护和环境利益保护为目标,充分发挥不同法律责任方式的功能、合理配置法律责任规则,在明确分工的基础上建立环境法律责任之间的有机联系,方可形成功能协调的环境法律责任体系保障环境法的实施。     

License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions

Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish patent protection for inventions deemed to have commercial potential and license them for product development. Such licenses help stimulate economic development and job creation, bring a stream of royalty revenue to the institution and, hopefully, advance the public good or public health by bringing new and useful products to market. In the course of applying for such licenses, a commercial development plan is usually put forth by the license applicant. This plan indicates the path the applicant expects to follow to bring the licensed invention to market. In the case of small molecule drug compounds, there exists a widely-recognized series of clinical development steps, dictated by regulatory requirements, that must be met to bring a new drug to market, such as completion of preclinical toxicology, Phase 1, 2 and 3 testing and product approvals. These steps often become the milestone/benchmark schedule incorporated into license agreements which technology transfer offices use to monitor the licensee's diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind.This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH's exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic benchmark schedule.     

单边主义与环境保护

前　言单边主义是一个近来在外交领域、司法和仲裁机构以及媒体中重新引起注意的概念。虽然单边主义被用来象征性地批评不同的实践活动 ,但是它本身并没有法律意义。这个概念既宽泛又杂乱 ,因而被作为万能钥匙去涵盖具有国际影响的各种法律、措施和行为。其中有些只具政治性 ,而另一些则有法律内容并能产生法律效力。大多数单边行为具有一个共同特征 ,即由一个或者几个国家联合采取、主张或者实施某种行为 ,并对其他国家产生重要影响。在一个由平等的主权国家组成的无中心社会中 ,被过于宽泛定义的单边主义 ,常被看作是国际关系常态的一部分…     

Disintegration: Environmental Protection and Article 81 EC

This article addresses the question of whether the modernisation and decentralisation of EC competition law will affect the integration of environmental protection requirements into the framework of Article 81 EC. First, the interface between competition policy and environmental protection at both the constitutional level and operational level is investigated. Following this, the Commission's assessment of environmental benefits under Article 81(3) EC prior to decentralisation and modernisation is explored. It is submitted that the Commission's expansion of its interpretation of the first two positive criteria of Article 81(3) EC allowed environmental objectives and competition goals to be balanced within the framework of Article 81 EC. Finally, this article examines the extent to which the decentralisation and modernisation of Community competition law may impede the integration of environmental protection into the definition and implementation of Article 81 EC.     

Social Justice and Environmental Management: An Introduction

Social Justice Research -     

Communicating to the Courts and Beyond: Why Members of Congress Participate as Amici Curiae

Members of Congress engage in discretionary behaviors, such as making speeches and cosponsoring bills, which are generally motivated by either electoral needs or policy preferences. We examine a discretionary behavior that engages the judicial branch in the conversation: the participation of members of Congress as amici curiae before the Supreme Court. Amicus curiae briefs provide members of Congress with a direct avenue of communication with the judiciary, and this characteristic suggests that cosigning would be a method of creating good public policy. Using data from the 1980–97 terms of the Supreme Court, however, we find that members of Congress cosign onto amicus curiae briefs as a means of “taking stances,” akin to cosponsoring a bill. The action allows the member to speak indirectly to an audience beyond these governmental institutions. Evidence shows that ideological extremism and committee jurisdiction promote participation as amicus curiae.     

Constructing the License to Operate: Internal Factors and Their Influence on Corporate Environmental Decisions

Voluntary programs intended to improve corporate environmental practices have proliferated in recent years. Why some businesses choose to participate in such voluntary programs, while others do not, remains an open question. Recent work suggests that companies' environmental practices, including their decisions to participate in voluntary programs, are shaped by a license to operate comprised of social, regulatory, and economic pressures. Although these external factors do matter, by themselves they only partially explain business decision making, since facilities subject to similar external factors often behave differently. In this article, we draw from organizational theory to explain why we would expect a company's license to operate to be ultimately constructed by internal factors, such as managerial incentives, organizational culture, and organizational identity, as these shape both interpretations of the external pressures and organizational responses to them. Using qualitative data from an exploratory study of matched facilities that reached different decisions about participating in a prominent voluntary environmental program, we then report evidence indicative of the role of these internal factors in shaping facilities' environmental decisions. Finally, we offer suggestions for future research that could further develop understanding of how internal organizational characteristics influence environmental management decisions, including those concerning participation in voluntary programs.     

Societal and Managerial Implications of Implicit Social Cognition: Why Milliseconds Matter

This article argues for the vulnerability of managerial work to unintended forms of racial and other bias. Recent insights into implicit social cognition are summarized, highlighting the prevalence of those mental processes that are relatively unconscious and automatic, and employed in understanding the self and others. Evidence from a response-time measure of implicit bias, the Implicit Association Test, (IAT; Greenwald, McGhee, and Schwartz, 1998) illustrates this phenomenon. Recent work on the predictive validity of the IAT demonstrates that social cognitive pitfalls threaten a) managers' explicit commitments to egalitarianism and meritocracy and b) managers' performance in their three primary roles of processing information, interacting with others, and making decisions (Mintzberg, 1973). Implicit bias influences managerial behavior in unexpected ways, and this influence is heightened in the messy, pressured, and distracting environments in which managers operate.     

外资征收与环境保护——不补偿环境征收之合法性刍议

由于环境保护关系到人类整体和国际社会共同利益,在外资征收的立法与实践中环境保护和外资保护应予一体化考虑,但现状却反映出外资私益优先于环境公益的倾向。从建立国际经济新秩序的角度看,为使发展中国家不致因环保因素付出不必要的代价,环境征收不应具有补偿性。而且,不补偿环境征收合法性根植于污染者付费原则、预防原则、治安权例外以及国际环境法义务优先原则。