Commercialisation of regenerative human tissue: regulation and reform in Australia and England, Wales and Northern Ireland

The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.     

Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim final rule to except human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act (the act), from the scope of the definition of "human cells, tissues, or cellular or tissue-based products (HCT/P's)" subject to the registration and listing requirements contained in 21 CFR part 1271. That definition became effective on January 21, 2004. FDA is taking this action to assure that these products, which are currently subject to the act and therefore regulated under the current good manufacturing practice regulations set out in the quality system regulations in 21 CFR part 820 are not released from the scope of those regulations before a more comprehensive regulatory framework applicable to HCT/P's, including donor suitability requirements, good tissue practice regulations, and appropriate enforcement provisions, is fully in place. When that comprehensive framework is in place, FDA intends that human dura mater and human heart valves will be subject to it. FDA intends to revoke this interim final rule at that time.     

Methods for detection and confirmation of Hematide™/peginesatide in anti-doping samples

Since the 1990's, cheating athletes have abused substances to increase their oxygen transport capabilities; among these substances, recombinant EPO is the most well known. Currently, other investigational pharmaceutical products are able to produce an effect similar to EPO but without having chemical structures related to EPO; these are the synthetic erythropoiesis stimulating agents (ESAs). Peginesatide (also known as Hematide?) is being developed by Affymax and Takeda and, if approved by regulatory authorities, could soon be released on the international market. To detect potential athletic abuse of this product and deter athletes who consider cheating, we initiated a collaboration to implement a detection test for anti-doping purposes. Peginesatide is a synthetic, PEGylated, investigational, peptide-based erythropoiesis-stimulating agent that is designed and engineered to stimulate specifically the erythropoietin receptor dimer that governs erythropoiesis. It is undetectable using current anti-doping tests due to its lack of sequence homology to EPO. To detect and deter potential abuse of peginesatide, we initiated an industry/antidoping laboratory collaboration to develop and validate screening and confirmation assays so that they would be available before peginesatide reaches the market. We describe a screening ELISA and a confirmation assay consisting of immune-purification followed by separation with SDS-PAGE and revelation with Western double blotting. Both assays can detect 0.5 ng/mL concentrations of peginesatide in blood samples, enabling detection for several days after administration of a physiologically relevant dose. This initial report describes experimental characterization of these assays, including testing with a blinded set of samples from a clinical study conducted in healthy volunteers.     

Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.     

Legal Theory and Dialectically Contingent Justifications for the Principle of Generic Consistency

Abstract. It is argued that accepting that there are human rights, or that there are categorically binding requirements of any kind on action, logically requires accepting the PGC (Principle of Generic Consistency ) as the supreme criterion of practical reasonableness.
Consequently, all legal systems that recognise human rights (hence, the English legal system), all who view law as a matter of obligation, and all who consider that there are categorically binding requirements on action, must take the PGC to be a necessary criterion of legal validity. Conventions on human rights must, as conventions on human rights , be interpreted to conform with the PGC .     

Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals

The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient--transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also increase the risk of further unnecessary biotechnology scares, which may cause public overreaction against biotechnology products, preventing the maximization of social welfare. With science and society poised to soar from first-generation biotechnology (focused on crops modified for agricultural benefit), to next-generation developments (including transgenic fish, insects, and livestock, and pharmaceutical-producing and industrial compound-producing plants and animals), it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system. This Article details how to achieve such a result through fixing the deficiencies in, and risks created by, the current regulatory structure. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks.     

The New Business of Nanotechnology: Exploring Commercial Opportunities and Risks

There is an Alice-in-Wonderland awe associated with nanotechnology. While the technology is both exciting and hopeful for many good reasons, for businesses, and the lawyers who counsel them, the lack of certainty in areas involving potential risk is unsettling. The U.S. Environmental Protection Agency (EPA) is only now beginning to think through how best to apply the authority it has under the traditional environmental statutes, and to adopt regulatory programs and policies to address the potential risks and regulatory challenges nanotechnology invites. While research is progressing briskly on key hazard and exposure nanotechnology issues, much remains to be done leaving commercial applications of nanotechnology in new, unsettled waters. This article identifies some of these challenges and the non-conventional, innovative ways that lawyers, business managers, risk assessors, and others must embrace to manage risk and avoid liability effectively.     

ADJUDICATING THE REGULATORY PENALTIES AGAINST NONPROFESSIONAL TAXI SERVICES IN CHINA AND THE EUROPEAN UNION

This paper provides an overview of judicial decisions on lawsuits against regulatory penalties imposed on nonprofessional taxi drivers and ride-hailing platform operators in China and the European Union (especially Germany). Despite strikingly different facts in these cases, courts in both China and the EU are frequently called upon to rule on similar legal issues, including the applicability of old regulatory rules to new forms of transport services, the regulatory bar for the operation of emerging transport models, and the proper intensity of competition in taxi markets. The comparison of such cases suggests that for deciding the regulatory schemes of the innovative economy of transport services, the judicial system is not better suited than the regulatory system, especially the regulatory authority of the central government. Moreover, an experimental regulatory approach with minimum standards is arguably a feasible option that can fit with the emerging nature of innovative businesses.     

Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products. FDA is also amending the registration and listing regulations that currently apply to human cells, tissues, and cellular and tissue-based products regulated as drugs, devices, and/or biological products. These actions are being taken to establish a unified registration and listing program for human cells, tissues, and cellular and tissue-based products.     

区块链技术在政府监管中的定位及法律规制——基于海关监管的视角

“区块链+”已经开始延伸到政府监管的应用场景,其有利于提升监管的整体效能。鉴于区块链技术在政府监管中的定位及法律规制问题的复杂性,海关监管是合适的样本。区块链背景下我国海关监管存在交易主体虚拟化、交易过程无纸化以及交易信息中心化的问题。为此,需要客观冷静看待区块链技术在海关监管中的定位,它不仅仅是海关监管过程中的技术增量,也是优化海关监管流程的重要推手,更能够孵化实现海关监管核心目标的创新措施,但也存在着双刃剑的负面效应,应通过确定多维宽容的规制理念、拓展行业协会与企业为规制主体以及鼓励适用柔性规制方法来构建我国区块链海关监管的法律规制体系。同时,我国必须秉承国际视野,把向国际社会提供一个完整的、带有普适性的区块链技术政府监管方案作为远期的重要目标。     

Environmental crime and problem-solving courts

Environmental harms are by their nature complex and as such give rise to formal legal responses that range from simple regulatory intervention to multi-faceted court order. The purpose of this paper is to explore the emergence of environmental courts and the development of judicial and tribunal expertise in this specific area. A wide range of sanctions are now available and being actively applied by such bodies. Moreover, in many instances, the philosophical approach adopted by these courts is that of problem-solving. The combination of specialist expertise and innovative methods of intervention are progressively revolutionising judicial practice in regards to contemporary environmental issues.     

Better Regulation of Industry-Sponsored Clinical Trials Is Long Overdue

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products.     

Regulating transnational corporate bribery: Anti-bribery and corruption in the UK and Germany

Recent large-scale cases involving multi-national corporations such as the BAE Systems and Siemens bribery scandals illustrate the difficulties faced by the UK and German sovereign states in controlling complex trans-national and multi-jurisdictional crimes. This article analyses the mixture of enforcement, self-regulatory and hybrid mechanisms that are emerging as part of UK and German responses to controlling transnational corporate bribery. This regulatory landscape incorporates a diverse array of direct and indirect state and non-state ‘regulatory’ actors of varying levels of formality. Mechanisms of a self-regulatory nature vary in terms of their mandatory/voluntary requirements and manufactured/organic formation. However, there is an assumption that the emergence of a variety of enforcement, self-regulatory and innovative hybrid mechanisms is sufficient but in reality this is not the case. Instead, the key argument of the article is that while these mechanisms are aiding the response, they are likely to fail leading to the default position of accommodation by state agencies, even where the will to enforce the law is high.     

Postmarketing studies for approved human drug and licensed biological products; status reports. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products. This rule describes the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. This action will implement the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers

In the "post-genomic" age of biomedical research, researchers often wish to utilise collections of human tissue. This type of research raises many ethical and legal issues and anyone wishing to use such collections is faced with an enormously complex set of regulatory requirements, many of which are still ambiguous, reflecting ongoing ethical and legal debate. Whilst there is no way of entirely avoiding such regulatory complexity and ambiguity, conceptual frameworks can assist those who wish to use, administer, authorise and generate policy on tissue banking research. Two conceptual frameworks are described here: a taxonomy of tissue banking practices, aimed at assisting those who need to ensure that tissue banks meet ethical and legal requirements; and a "syncretic" approach to policy-making, for those who wish to generate new policy, or streamline existing policy relating to tissue banking research.     

Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning

The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.     

Constitutional Reasoning in Private Law: The Role of the CJEU in Adjudicating Unfair Terms in Consumer Contracts

This article explores the—often controversial—role of the CJEU as an interpreter of Directive 93/13/EEC on unfair terms. A fundamental problem that any modern system of private law must address is how to combine two types of provisions: those that are intended to facilitate private ordering through voluntary transactions, and those setting out certain mandatory terms that are intended to protect vulnerable consumers against risks inherent to free market transactions. This article argues that, in response to the failure of various legislative initiatives, the Court's jurisprudence has acquired both a regulatory dimension and a constitutional dimension. The emergent judicial regime illustrates an important departure from a rule‐based conception of private law, based on private autonomy as a stand‐alone value, towards an innovative conception that extends proportionality analysis into substantive private law but avoids one‐sided outcomes.     

The taphonomic impact of scavenger guilds in peri-urban and rural regions of central and southern Alberta. Part I – Identification of forensically relevant vertebrate scavengers

As a body decomposes in an outdoor environment, numerous taphonomic agents can act on the process of human decomposition. It is important to understand the impact of these agents as they can vary the rate of soft and hard tissue loss which may alter postmortem interval estimations. One taphonomic factor which has not been extensively investigated in many regions of the world, including Canada, are vertebrate scavengers. The current study aimed to identify scavenger guilds in the peri-urban and rural regions of two major cities in Alberta (Calgary and Edmonton) where human remains are frequently located. Vertebrate scavenger activity was recorded continuously using cellular and noncellular trail cameras. Images were analyzed to determine how the scavenging profiles (i.e., scavenger species, arrival time, and feeding behavior) impacted the loss of soft and hard tissue. We identified a range of mammalian and avian scavengers and found that coyote and black-billed magpie were the predominant scavengers recorded at the Edmonton peri-urban and rural sites, and the Calgary peri-urban sites. In contrast, when a site was within bear territory such as the Calgary rural sites, black and grizzly bears were the predominant scavengers. At all sites, the large mammalian scavengers were responsible for most soft tissue loss and subsequent hard tissue dispersal. None of the scavengers demonstrated a clear preference for open versus closed sites. This taphonomic information is important to consider when searching for human remains at these locations or in other North American regions with comparable scavenger guilds.     

Options for state and local governments to regulate non-cigarette tobacco products

Most tobacco control laws were written to address the scourge of smoking--particularly smoking cigarettes. As a result, these laws frequently exclude non-cigarette tobacco products, which are becoming more prevalent on the market. These regulatory gaps jeopardize public health by increasing the possibility that these products will be used--particularly by minors and young adults. This article examines gaps in regulation using five products as case studies: dissolvable tobacco products, electronic cigarettes, little cigars, snus, and water pipes. In addition, this article presents policy options that state and local governments can adopt to regulate these products more effectively, including regulations relating to price, flavors, youth access, use in public places, point-of-sale warnings, and marketing. Furthermore, this article contains extensive discussion of the recently adopted federal Family Smoking Prevention and Tobacco Control Act, which both limits and expands the power of state and local governments.     

英国执行欧盟细胞指令的经验和启示简

英国为执行欧盟人体组织和细胞三个指令在立法和执法上所作的努力及其获得的成功,对于我国建立人体组织细胞法律制度,发展监管科学,有效治理“干细胞治疗”乱象,具有重要借鉴价值.在实证的基础上,分析、介绍英国人体组织法的基础、基本制度和运作方式,设想中国干细胞疗法监管科学的框架,应当包括监管的目标和长远战略、科学立法、制度文化、监管体制与执法机制、行业治理、患者维权的伦理—法律问题等.