利益集团理论视角的药品安全问题解读

近年来,药品安全问题特别引人注目.本文认为权力制衡制度、监督机制的缺失致使规制机构的行为缺乏监督和约束,导致其不断迎合"特殊利益"集团的需要是药品安全问题的根源.为此,本文提出一种分析框架,即把规制机构看成是规制设计者和制药企业这两个具有不同偏好和利益的共同代理人,运用利益集团竞争理论来解读规制机构的行为以及药品安全规制效果.     

Connecting life science entrepreneurs with resources and expertise: the role of iungens brokerage in life science innovation

Life science innovation demands detailed expertise at each stage of the development of a commercial product. Besides a perceived shortage of venture capital, venturing life science companies face the challenge of limited access to qualified expertise in regulatory affairs and commercialisation. Examining a bio hub initiative at a major pharmaceutical company, a form of in-house incubator wherein life science companies can both take advantage of laboratory facilities and the stock of expertise of the hosting company, it is argued that such initiatives support the life science innovation field. Taking on an iungens brokerage role, the hosting company effectively connects previously separated actors, thus lowering the transaction costs incurred when accessing qualified scientific, regulatory, and commercial know-how, which are all of great value to life science companies during the venturing phase. The iungens brokerage role thus represents a highly valuable position in the field of life science innovation.     

Technological races and stock market value: evidence from the pharmaceutical industry

We provide estimates of the abnormal stock market returns associated with pharmaceutical firms’ announcements of technological and regulatory successes in drug development. On the basis of these estimates, we find empirical support for two key features of technological race models. First, we observe that leaders in the innovation race record higher abnormal returns than do latecomers when they announce a success. Hence, firms should indeed be racing to complete the innovation process before their rivals. Second, pharmaceutical firms are adversely affected by the technological and regulatory success of their rivals, implying that interfirm spillovers in drug development are not sufficient to offset technological rivalry. Additional results are also produced regarding the impact of competition on R&D racing and the extent of therapeutic competition.     

The future of drug discovery and development: Shifting emphasis towards personalized medicine

The drug discovery sector is being revolutionized by the current rate of advances in the public and private human genome projects and by the development of new technologies for biomarker testing. In effect, as the genetic roots of disease, disease progression and treatment effectiveness are uncovered, the demand for sophisticated prognostic, diagnostic and monitoring tests will be increasing. Already this has led to the development of innovative diagnostics products meeting the criteria of improved efficacy and safety as well as better cost-benefits. In order to achieve the ultimate goal of a more predictive and personalized medicine requires the drug discovery industry to implement more synergies between the two worlds of clinical research and diagnostics. The therapeutics that are enabled by that strategy are often called “theranostics” — highly specific tests that allow for the diagnosis of the disease, but to administer the most appropriate treatment regimen, and to monitor a patient's response to therapy. Biomarkers will constitute a critical component of the health care delivery system in order to detect, diagnose and monitor diseases and other medical conditions as well as to evaluate treatment options and effectiveness. While diagnostic breakthroughs typically precede therapeutic advances, the presence of new therapies can stimulate the demand for testing. The main question that remains to be answered is how will the biomarker paradigm alters these companies' innovation and commercialization strategies. Whereas developing drug targets may offer greater long-term value, initial commercial opportunities often arise in diagnostics.     

IMPORTATION AND INNOVATION

Importation of drugs into the US may soon become legal. Since prices of drugs are lower in most other countries than they are in the US, importation would result in a decline in US drug prices. The purpose of this paper is to assess the consequences of importation for new drug development. First, the author presents a simple theoretical model of drug development which suggests that the elasticity of innovation with respect to the expected price of drugs should be at least as great as the elasticity of innovation with respect to expected market size (disease incidence). Then, the cross-sectional relationship between pharmaceutical innovation and market size among a set of diseases (different types of cancer) exhibiting substantial exogenous variation in expected market size is examined. Two different measures of pharmaceutical innovation are analysed: the number of distinct chemotherapy regimens for treating a cancer site and the number of articles published in scientific journals pertaining to drug therapy for that cancer site. Both analyses indicate that the amount of pharmaceutical innovation increases with disease incidence. The elasticity of the number of chemotherapy regimens with respect to the number of cases is 0.53. The elasticity of MEDLINE drug cites with respect to cancer incidence throughout the world is 0.60. In the long run, a 10% decline in drug prices would therefore be likely to cause at least a 5–6% decline in pharmaceutical innovation. Evidence suggests that pharmaceutical industry employment would also decline (by at least 3.5–4%) in response to an exogenous 10% decline in drug prices.     

美国信用评级业及其未来的监管政策调整

美国次贷危机的爆发使得信用评级机构声誉日下,同时也使得美国信用评级业存在的问题进一步暴露.金融创新背景下的美国信用评级业其实存在着许多内在矛盾和困境.因此,以下三个方面将是其监管政策调整的重点: (1)强化竞争机制,调整信用评级现有市场结构; (2)加强信息披露,提高评级活动的可审核性; (3)保证评级活动的独立性,促使评级结果的公正与客观.     

药品专利制度的现实困境及反思

药品研发及市场化具有高风险、高投入特征，药品专利制度通过为制药企业提供专利期内垄断市场激励,促进药物创新。TRIPS协议在全球范围内建立了对药品专利的高标准保护，然而这一药品专利国际保护制度突出了药品专利私权属性以及对利润的过分追求，在现实中引发了药品创新悖论与药品获得困难两方面问题。借鉴并完善国际社会已有的药物研发多元融资措施、税收优惠机制以及公私合作模式，有助于纾解药品专利制度面临的现实困境。     

The Effects of Public Ownership and Regulatory Independence on Regulatory Outcomes

We examine the effects of public ownership and regulatory agency independence on regulatory outcomes in EU telecommunications. Specifically, we study regulated interconnect rates paid by entrants to incumbents. We find that public ownership of the incumbent positively affects these interconnect rates, and suggest that governments influence regulatory outcomes in favor of incumbents in which they are substantially invested. However, we also find that the presence of institutional features enhancing regulatory independence from the government mitigates this effect. In order to study regulatory independence, we introduce a new cross-country time-series database—the European Union Regulatory Institutions (EURI) Database. This database describes the development of institutions bearing on regulatory independence and quality in telecommunications in the 15 founding EU member states from 1997 to 2003 *We thank Laurent Pipitone for superb research assistance. Geoff Edwards thanks the Sasakawa Foundation and the Institute of Management, Innovation and Organization at the Haas School of Business for generous financial assistance, and London Business School for non-financial support. Leonard Waverman thanks the Global Communications Consortium for support     

The effects of patent-law changes on innovation: The case of India's pharmaceutical industry

Recent patent-law changes in India's pharmaceutical industry provide opportunities to study changes of institutional and regulatory environments on innovation and social welfare in low-income markets. From 1972 to 2004 under its process-patent regime, India's pharmaceutical industry grew to become the world's fourth largest. Indian companies were becoming globally competitive in generics and clinical testing, and moving into product R&D. Researchers have debated the effects of India's new product-patent laws' effects on these trends. The authors cover the domestic characteristics and global competitiveness of India's pharmaceutical industry. They contrast data (from 2001 to 2004) on patents in India's process-patent regime with preliminary data (from 2005 to 2008) on patents in the country's new product-patent regime. They argue that Indian pharmaceutical companies have changed their decision-making in response to changed patent laws by moving from process to product research. However, the preliminary results indicate that these changes may have hurt domestic innovation. They conclude with strategic implications for the Indian pharmaceutical industry and highlight the need for research and public policy to establish optimal social returns from product-patent regimes.     

Pricing dynamics and product quality: the case of antidepressant drugs

The rising prices of pharmaceuticals have generated considerable, and often acrimonious, debate. Yet, there is little conceptual work or empirical evidence on pharmaceutical pricing strategies or on the time paths of these prices. This study provides a conceptual framework describing the interplay between quality and product differentiation in determining the preferred pricing strategy. We hypothesize that higher quality products will engage in price skimming strategies in markets where products are sufficiently differentiated, but will choose a market penetration strategy in markets that are less differentiated. We apply an empirical analysis to brand name antidepressants during the years 1999–2002, a market where differences in quality are modest. A nationally representative data set on drug utilization and expenditures is combined with a physician survey on the quality attributes of drugs to examine the effect of drug quality on pharmaceutical pricing strategies. Results indicate that higher quality antidepressants engage in a market penetration strategy, charging initially lower prices that rise over time. At approximately 6–7 years post-entry, prices of the antidepressant drugs examined converge. Prices of higher quality antidepressants continue to increase thereafter, eventually becoming the highest priced drugs in the therapeutic class. These findings are consistent with a market in which product differentiation is modest and consumers learn which drug works best for them through experience.     

药品专利链接制度建构的中国方案：理论、原则与路径

药品专利链接制度作为专利纠纷的早期解决机制，解决了药品上市行政许可与专利权保护的衔接机制问题,该制度的创设遵循我国私有财产不受侵犯的宪法原则。制度构建应以法益衡平理念为基本指导原则，结合我国药品监管体系、医药产业政策和专利行政、司法保护运行机制设计相关内容，该制度构建涉及行政权、财产权、健康权之间的冲突与协调问题。我国具体制度设计应遵循生命健康权优先保护、合理保护、效率与公平兼顾协调3个原则，重点调和不同利益主体之间的紧张关系。除科学设置药品上市目录集、专利声明、暂缓审批期、首仿药市场独占期外，还应注重药品专利链接制度与药品试验例外、专利诉讼、专利行政处理、强制许可等制度的协调与衔接。     

Toxicogenomic predictive modeling: Emerging opportunities for more efficient drug discovery and development

Drug discovery companies are coming under increasing pressure to prove the long-term safety of their products more precisely, and to provide more data on them. As highlighted by Vioxx, for many drugs, the existence of adverse drug reactions (ADRs) becomes apparent once the compound has been extensively prescribed and a population base of considerable size has been exposed to the therapeutic agent. The ability to make decisions regarding termination of clinical development of a non-viable drug candidate as early as possible will have a large financial impact for a pharmaceutical company. Knowledge regarding the interactions of chemicals, genes, and cell function can improve chemical risk analyses. These efforts will be aided by continued improvement and expansion of predictive toxicology in combination with a range of mutually supportive technologies to develop strategies to facilitate better and more focused decision-making throughout the drug discovery process. Failure to implement such an approach causes companies to withdraw drugs from development or the market. This not only presents human health consequences but also has a negative economic impact on the industry. As such, one of the major challenges in drug discovery is to accurately predict which new drugs will be associated with a significant incidence of ADRs. The ability to produce information on potential toxicity early in the discovery phase will become the basis for judging whether a drug candidate merits further development.     

药物经济学在我国药品定价中应用的定位分析

目的为药物经济学在我国药品定价中的正确应用提供政策建议。方法通过介绍我国药品价格管制措施的局限性,探讨药物经济学在药品定价中应用的可行性及必要性,进一步分析药物经济学在药品定价中应用所需的明确定位。结果与结论在药品定价中药物经济学所评价的药物范围应为新药和专利期内的垄断药品。作为应用主体的定价部门应站在全社会角度通过制定权威的药物经济学评价指南,委托第三方专家组对制药企业提交的药物经济学评价报告进行评估,将评估结果作为药品定价部门与制药企业谈判协商价格时的科学依据,在达到对新药和专利期内垄断药品控费的同时,鼓励药品创新和研发,最终保证患者对药品持续的可及性。     

The governance of agro- and pharmaceutical biotechnology innovation: Public policy and industrial strategy

Multinational companies in the life science sector are heavily influenced by government policies and regulations and in turn attempt to influence these actors nationally and internationally. This paper focuses on recent and on-going research, principally on the agro-biotechnology and, to a lesser extent, on the pharmaceutical industries, covering the evolution of policy and regulation in Europe, how policies are influenced by stakeholder pressures and how policy in turn influences company strategies for product development. We focus particularly on new 'governance' agendas in Europe and consider the relative impacts of enabling, constraining, discriminating and indiscriminate policies on company strategies as part of our development of an integrated approach to policy and governance. We also consider changes in external operating environments for multinational companies and compare past histories and present pressures on agro-biotechnology and pharmaceutical companies. The paper argues, with evidence, that a more enabling and discriminating policy and regulatory environment can achieve public goals more efficiently and effectively, taking account of impacts on innovation, than more blunt policy instruments. This type of environment takes into account the resources and capabilities available to firms and research laboratories rather than relying on broad brush carrot and stick approaches.     

科技计划与科技标准协同创新模式研究

科技计划和科技标准协同创新是科技创新的关键。对科技计划和科技标准协同创新进行基础性研究：阐述科技计划和科技标准协同创新内涵、关键要素以及特征等基础理论，研究科技计划和科技标准协同创新模式，并结合我国科技计划、科技经费与财务标准协同情况进行分析，提出我国科技计划和科技标准协同创新建议。     

The governance of agro- and pharmaceutical biotechnology innovation: Public policy and industrial strategy

Multinational companies in the life science sector are heavily influenced by government policies and regulations and in turn attempt to influence these actors nationally and internationally. This paper focuses on recent and on-going research, principally on the agro-biotechnology and, to a lesser extent, on the pharmaceutical industries, covering the evolution of policy and regulation in Europe, how policies are influenced by stakeholder pressures and how policy in turn influences company strategies for product development. We focus particularly on new ‘governance’ agendas in Europe and consider the relative impacts of enabling, constraining, discriminating and indiscriminate policies on company strategies as part of our development of an integrated approach to policy and governance. We also consider changes in external operating environments for multinational companies and compare past histories and present pressures on agro-biotechnology and pharmaceutical companies. The paper argues, with evidence, that a more enabling and discriminating policy and regulatory environment can achieve public goals more efficiently and effectively, taking account of impacts on innovation, than more blunt policy instruments. This type of environment takes into account the resources and capabilities available to firms and research laboratories rather than relying on broad brush carrot and stick approaches.     

PROPERTY RIGHTS, REGULATORY TAKING, AND COMPENSATION: IMPLICATIONS FOR ENVIRONMENTAL PROTECTION

The 104th Congress considered several proposals requiring compensation for regulatory actions that diminish property values. Aimed primarily at weakening environmental protection, the bills focus on property rights independent of the public benefits from regulation. By significantly broadening the constitutional standard for compensation, the bills generate a government liability well in excess of compliance costs and thus discourage regulatory agencies from carrying out their mandates. The bills would increase transactions costs and undermine the efficient provision of environmental quality, public safety, and other public goods.     

Regulatory foresight: Methodologies and selected applications

This paper on regulatory foresight addresses approaches which allow future fields for regulatory action to be identified. We follow a rather wide perception of regulation and include standards and standardisation as elements of the regulatory framework. The paper presents three methodologies appropriate for performing regulatory foresight. First, an approach is presented which makes use of science and technology indicators and enables the identification of possible fields which may cause challenges for the regulatory framework and the regulatory bodies. Second, survey approaches are displayed which enable regulatory bodies to identify future needs for regulations. Finally, the usability of the Delphi methodology is discussed and results of a Delphi survey in the telecommunication area are presented. The paper concludes with a comparative analysis of the three methodological approaches regarding their effectiveness to conduct regulatory foresight.     

Strategic technology management issues in japanese manufacturing industry

The argument that regulation is a necessary, though controversial, component of technology policy is discussed in detail. Ib addition to the regulation of technology, various other regulatory policies, such as market regulation, affect the development of technology. Various types of direct regulation and their conditions of operation are discussed. It is shown that regulation can afect technological innovation positively by providing a surrogate market. The paper serves as an introduction to this special issue and shows how the different contributions fit into a general framework of regulatory effects on technolgy. Regulation as a factor in competition is discussed, particularly in the context of developing countries.     

Making profits working on patients’ expectations, a behavioral analysis of pharmaceutical clinical research

This paper presents a model that demonstrates how pharmaceutical companies can make profits from human experimentation by working on patients?? expectations and physicians?? inability to evaluate innovations in medical knowledge. In order to understand how profits can be made, it is important to analyze the effect the physician??s expectations have on patients, both in the enrolment process and in the collected effectiveness, as well as the nature of the physician??s interest in producing this effect. Starting from the process through which companies collect clinical evidence, the analysis will focus on the economic use of that data on the drug market and the national drug agency??s role. A model illustrates the companies?? potential opportunistic strategies as well as what the public stakeholder??s target should be. Is public intervention really necessary in order to regulate the imperfect market of drugs? In other words, taking imperfection due to the expectation process in human experimentation into account, is there another practicable path? The final normative analysis will try to answer these questions.