The orphan works dilemma and museums: an uncomfortable straitjacket

LEGAL CONTEXT: Orphan works are copyright works where the right holders cannotbe found. Without the consent of the right holder, a user facespotential liability for the unauthorized use of the work. Museumshave a duty to make cultural materials available to the public.However, the orphan works problem may pose obstacles to thenormal functioning of a museum. This article explores the problemof orphan works as it pertains to museums. KEY POINTS: Legislative solutions are being considered in addressing theproblem of orphan works in the United States. The museums, asa lobbying group, initially advocated for a safe-harbour rule.The U.S. Copyright Office recommended a limitation on remediesrule. Any legislative solution tackling the orphan works problemmust balance the benefits of using orphan works against theexclusive rights of creators. PRACTICAL SIGNIFICANCE: This article will inform readers of the orphan works problem.In addition, the lobbying efforts of the museums in trying toobtain desirable legislation are explored. By understandingthe various interests involved, readers can better anticipatethe possible orphan work solutions that the United States mayadopt.     

Patents for critical pharmaceuticals: the AZT case

Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceutical company owning the drug have led to public outcry and a re-examination of government incentive systems. This Note traces the evolution of these incentive programs--the patent system, and, to a lesser extent, the orphan drug program--and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future.     

论孤儿作品的版权利用——兼论《著作权法》(修改草案)第25条

孤儿作品是作者身份不明或者虽然作者身份明确但查找无果的作品。网络与电子信息技术的蓬勃发展使得孤儿作品问题愈发突出,有必要对Google案和解协议及西方国家孤儿作品利用模式进行审视。同时,《著作权法》(修改草案)对孤儿作品的制度设计须进一步细化与完善,明确孤儿作品范畴,细化勤勉查找义务,并确立孤儿作品的强制许可模式。     

Triage in the nation's medicine cabinet: the puzzling scarcity of vaccines and other drugs

For a variety of reasons, vaccines and other critical pharmaceutical products have become increasingly scarce in the last few years, and persistent shortages involving dozens of essential drugs may imperil the public health. Pressures emanating from regulatory agencies, the courts, and insurers have conspired to make some lines of the pharmaceutical business less than attractive. Although concerns about unpredictable tort liability received most of the blame in the past, two other factors may help to account for the latest round of drug shortages: stringent federal control of manufacturing facilities and aggressive cost-containment efforts that further erode profit margins. Whatever the cause, scarce supplies necessitate efforts at rationing that pose their own difficulties for health care providers. Policymakers could avoid putting physicians to such tough choices regarding patients by focusing on ways to ensure the production of adequate quantities of these highly cost-effective medical technologies. Some commentators have called for greater public sector involvement, but this Article concludes that, in addition to bolstering its emergency stockpiles, the federal government instead needs to take steps designed to encourage private manufacturers to continue supplying critical pharmaceuticals. To this end, the government should adopt more flexible regulations governing manufacturing facilities, provide companies with greater protection from the vagaries of tort liability, and avoid pursuing excessive cost-control strategies. Otherwise, patients may continue to lose access to important therapeutic products.     

Reallocating liability to medical staff review committee members: a response to the hospital corporate liability doctrine

Under the doctrine of hospital corporate liability, the hospital governing board bears the responsibility for detecting the incompetence of its staff physicians. Since hospital governing boards are generally composed of lay community members, they lack the expertise to evaluate the clinical competence of their staff. Therefore, they must delegate their screening responsibilities to medical staff review committees. After analyzing the development of hospital corporate liability doctrine, this Note examines the respective policing capabilities of review committees and the governing board. The Note contends that the board should not be held liable for aspects of the policing process which it is incapable of controlling. The Note concludes that, given their superior ability to evaluate clinical competency, staff review committees should shoulder the responsibility for the clinical aspects of staff evaluation, leaving remaining aspects to the hospital governing board. The Note proposes that courts should recognize a cause of action for negligence against medical staff review committee members in order to upgrade the effective policing of the medical profession.     

医疗机构药品缺陷责任的法律分析

药品缺陷责任法律制度关系人民群众切身利益，十分重要。我国相关法律制度十分不完善，既没有维护好受害者的权益，同时又未能将责任在责任主体间进行公平分担。现行法律制度根本无法达成以上目标，必须重新建构科学合理的药品缺陷责任制度。在此基础上，实践中医疗机构药品缺陷责任畸重的问题才能得到根本上的解决。     

Preconception tort liability: recognizing a strict liability cause of action for DES grandchildren.

Over the past decade more than 1,000 "DES daughters" have filed lawsuits against the manufacturers of DES, alleging that their in utero exposure to the drug caused various reproductive tract abnormalities, including cancer. Plaintiffs now allege that their grandmothers' use of DES during pregnancy caused genetic damage leading to cancer in third generations. This Note addresses the validity of preconception tort liability in the context of third-generation DES cases. Plaintiffs in preconception tort liability cases have sought recovery under both negligence and strict liability causes of action. Courts should recognize the validity of preconception tort liability and allow a strict liability cause of action in third-generation cases.     

The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing

On January 4, 2002, President Bush signed into law the Best Pharmaceuticals for Children Act, which is the government's most comprehensive legislation regarding pediatric research to date. The Act offers pharmaceutical companies a six-month exclusivity term in return for their agreement to conduct pediatric tests on drugs. It also provides public funding and organizes private funding to help conduct pediatric research on those drugs that pharmaceutical companies opt not to test in children. This Note reviews the history of pediatric research and traces the development of the Best Pharmaceuticals for Children Act's unique incentive and public funding structure. The Note contends that, while the Act is comprehensive and promotes important pediatric studies, its incentive structure forces consumers and taxpayers to bear the costs of testing pharmaceuticals in children instead of the manufacturers who research, develop, and market those drugs. Congress should consider mandating pediatric studies in any future enactment of the legislation.     

药品说明缺陷的法律分析

文章根据产品责任法理论阐述了药品缺陷的含义以及我国对药品说明的有关规定;并根据药品的特殊性,深入分析了药品说明缺陷的判断因素,以及认定药品说明缺陷的注意问题,有助于药品生产者、经营者、医师、药师等在产品和医疗服务中规范行事。提出在司法实践中,要确认生产者、销售者或医师是否存在说明缺陷,应对药品的说明对象、说明方式以及说明时间、说明的充分性以及对明显或众所周知的危险进行警告等方面进行综合考虑评估。     

Products liability issues in school asbestos litigation

The hazards posed by deteriorating friable asbestos in the nation's schools are causing serious concerns for public health officials, school boards, parents and school employees. Reports by both the Environmental Protection Agency and the U.S. Attorney General's Office agree that both school children and school employees stand a substantially increased risk of contracting some form of asbestos-related disease as a result of exposure to deteriorating asbestos materials in school buildings. School systems plagued by the asbestos hazards are now filing suits against asbestos manufacturers alleging causes of action in breach of warranty, negligence and strict products liability in tort. Some plaintiffs in school asbestos litigation seek to recover the costs of EPA-mandated asbestos inspection and abatement programs which have already been completed. Still others request injunctions to compel the manufacturers themselves to conduct inspections and finance abatement. This Note examines the school asbestos situation from a legal perspective and focuses primarily on whether the schools' claims should be considered as economic losses or as property damage. It examines the impact of statutes of limitations on these cases under both contract and tort theories. The Note argues that school asbestos claims should be decided under a strict products liability standard.     

完善我国药品不良反应救济机制的法律思考

药品不良反应是在正常使用合格药品时产生的有害或意外反应。因药品不良反应导致患者严重损害的,相关主体应对受害人进行赔偿。在我国现行法下,药品不良反应法律责任不同于医疗事故责任、产品责任和国家赔偿责任,而属于侵权法中的公平责任。我国应及早建立和完善药品不良反应救济机制,实行药品不良反应救济基金制度。     

Preferred provider organization liability for physician malpractice

The preferred provider organization (PPO) is a recent innovation in the health care industry, designed to reduce costs through selective contracting and utilization controls. This Note examines malpractice liability theories potentially applicable to PPOs. The Note compares PPOs to other health care institutions, including hospitals and HMOs, and concludes that PPOs are at minimal risk of incurring liability for physician negligence.     

美国产品责任法归责原则的演进

作为侵权责任法重要组成部分的产品责任法,其担当着平衡社会主体之间,尤其是消费者集团与生产者集团之间利益关系的重要角色。美国产品责任法经历了从合同责任到侵权责任,进而由一般侵权责任到特殊侵权责任的发展过程。从历史发展的角度,展现美国商品经济各个时期侵权责任法归责原则的不同表现,分析它们产生的时代背景、理论基础及法律渊源等因素,从而获得了美国产品责任法归责原则纵向发展的概貌、制度特色,从中可以发现对我国产品责任立法的借鉴意义。     

Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada

Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework.     

Understanding research methods,limitations, and applications of drug data collected by the National Forensic Laboratory Information System (NFLIS-Drug)

The National Forensic Laboratory Information System (NFLIS) is a drug surveillance program of the US Drug Enforcement Administration that systematically collects data on drugs that are seized by law enforcement and submitted to and analyzed by the Nation's forensic laboratories (NFLIS-Drug). NFLIS-Drug data are increasingly used in predictive modeling and drug surveillance to examine drug availability patterns. Given the complexity of the data and data collection, there are some common methodological pitfalls that we highlight with the aim of helping researchers avoid these concerns. The analysis done for this Technical Note is based on a review of the scientific literature that includes 428 unique, refereed article citations in 182 distinct journals published between January 1, 2005, and April 30, 2021. Each article was analyzed according to how NFLIS-Drug data were mentioned and whether NFLIS-Drug data were included. A sample of 37 articles was studied in-depth, and data issues were summarized. Using examples from the literature, this Technical Note highlights eight broad concerns that have important implications for the proper applications, interpretations, and limitations of NFLIS-Drug data with suggestions for improving research methods and accurate reporting of forensic drug data. NFLIS-Drug data are timely and provide key information to inform drug use trends across the United States; however, our present analysis shows that NFLIS-Drug data are misunderstood and represented in the literature. In addition to highlighting these issues, DEA has created several resources to assist NFLIS data users and researchers, which are summarized in the discussion.     

产品责任:北美视角的比较法评论

美国采纳严格产品责任的主要原因是:早期的法律不能给消费者提供充分的保护;调整保证的法律不是从消费者的角度出发的;美国的社会福利很大程度上不如其他西方国家。当今美国主要对于设计和信息性缺陷适用过失责任制度,严格产品制度仅适用于制造缺陷和非制造缺陷的销售者。欧洲和其他法域的严格产品制度远比美国严格。各种结构化和程序化的事务赋予美国公民更多诉至法院的机会。     

我国产品质量法评析

本文对我国产品质量法的立法体例进行了分析,认为我国现行的产品质量法立法体例不科学;应改变现行的立法体例,将产品责任立法凸现出来。本文还对构成产品质量法的一些基本概念进行了探讨。     

内幕交易侵权责任的因果关系

证券内幕交易侵权责任因果关系的研究,需要借助因果关系理论的发展并重新审视内幕交易的行为本质。投资者因内幕交易而致权益被侵害是完全被动的,"比较优势论"有助于实现对内幕交易行为及其侵权责任的整体认知。内幕交易侵害其交易对手——"善意同时反向交易者"之"以信息对称为核心的公平交易法益",而非投资者的"知情法益"。内幕交易行为提升了投资者亏损发生的客观可能性,二者之间具有事实上的因果关联。依托以原因力、有责性、公平性等若干要素为中心的理论与价值判断体系,并贯彻侵权法之填补及预防损害的补偿性功能,经论证可知内幕交易侵权行为引致的损失限定为对手"交易损失的一半",但应以相当于内幕交易人非法获利(包括所获收益或避免的损失)的投资者损失额为限。     

试论药品不良反应民事责任和救济制度

药品不良反应主要是指合格药品在正常用法用量的情况下出现的与用药目的无关的或意外的有害反应。药品发生了不良反应 ,应由有过错行为的生产经营者承担法律责任。在各方都无过错时 ,国家应当建立药品不良反应救济制度予以救济     

论金融服务者缔约说明义务违反之私法责任

义务乃责任之基础,责任为义务履行之法律保障。金融服务者违反缔约说明义务亦应承担法律责任。金融商品交易的本质决定了私法责任的核心地位,而我国现行立法却无法为金融服务者违反缔约说明义务私法责任提供理想的请求权基础。基于金融服务者与金融消费者地位极端不平等的现实,应当确立向弱势群体倾斜保护的特殊侵权责任。特殊侵权责任由无过错责任原则与举证责任倒置规则构成,对违法行为、因果关系以及损害赔偿额实行推定,以实现对金融消费者的救济。