Regulatory Trajectory Research Articles

Regulating Artificial Intelligence and Machine Learning-Enabled Medical Devices in Europe and the United Kingdom

Recent achievements in respect of Artificial Intelligence (AI) open up opportunities for new tools to assist medical diagnosis and care delivery. However, the typical process for the development of AI is through repeated cycles of learning and implementation, something that poses challenges to our existing system of regulating medical devices. Product developers face tensions between the benefits of continuous improvement/deployment of algorithms and keeping products unchanged. The latter more easily facilitates collecting evidence for safety assurance processes but sacrifices optimisation of performance and adaptation to user needs gained through learning-implementation cycles. The challenge is how to balance potential benefits with the need to assure their safety. Governance and assurance processes are needed that can accommodate real-time or near-real-time machine learning. Such an approach is of great importance in healthcare and other fields of application. AI has stimulated an intense process of learning as this new technology embeds in application contexts. The process is not only about the application of AI in the real world but also about the institutional arrangements for its safe and dependable deployment, including regulatory experimentation involving new market pathways, monitoring and surveillance, and sandbox schemes. We review the key themes, challenges and potential solutions raised at two stakeholder workshops and highlight recent attempts to adapt the laws for AI-enabled medical devices (AIeMD) with a special focus on the regulatory proposals in the UK and internationally. The UK regulatory trajectory shows signs of alignment with the US thinking, and yet the European Union model is still the most closely aligned framework.

Hypomethylation-induced regulatory programs in T cells unveiled by transcriptomic analyses.

Regulatory T cells (Tregs) are essential mediators of tolerance mitigating aberrant immune responses. While naturally occurring Treg (nTreg) development and function are directed by epigenetic events, induced Treg (iTreg) identity and mechanisms of action remain elusive. Mirroring the epigenetic circuits of nTregs, we and others have used hypomethylation agents (HAs) to ex vivo convert T cells into iTregs (HA-iTregs) and further showed that the suppressive properties of the HA-iTregs are predominantly confined in an emergent population, which de novo expresses the immunomodulatory molecule HLA-G, consequently providing a surface marker for isolation of the suppressive HA-iTreg compartment (G+ cells). We isolated the HA-induced G+ cells and their G- counterparts and employed high-throughput RNA-sequencing (RNA-seq) analyses to uncover the G+-specific transcriptomic changes guiding T cells toward a regulatory trajectory upon their exposure to HA. We found a distinct transcriptional upregulation of G+ cells accompanied by enrichment of immune-response-related pathways. Although single-cell RNA-seq profiling revealed regulatory G+ cells to have molecular features akin to nTregs, when assessed in conjunction with the comparative transcriptomic analysis and profiling of secreted cytokines against the non-suppressive G- cells, FOXP3 and other T-helper signatures appear to play a minor role in their suppressive phenotype. We found an ectopic expression of IDO-1 and CCL17/22 in G+ cells, denoting that in vitro exposure of T cells to HA may well unlock myeloid suppressor genes. This report provides transcriptional data shaping the molecular identity of a highly purified and potent HA-iTreg population and hints toward ectopic myeloid-specific molecular mechanisms mediating HA-iTreg function.

Distinct trajectories of caregiver-toddler physiological attunement during routine vaccinations.

Toddlers rely on their caregivers for regulatory support when faced with pain-related distress. The caregiver's ability to support their toddler relies on their capacity to regulate their own distress and respond effectively to the child's need for support. The aim of the current study was to describe patterns of caregiver-toddler physiological co-regulatory patterns, also known as attunement, during routine vaccinations across the second year of life. Caregiver-toddler dyads (N = 189) were part of a longitudinal cohort observed at either 12-, 18-, or 24-month well-baby vaccinations. Parallel-process growth-mixture modeling was used to examine patterns of dyadic physiological co-regulatory responses, indexed by high-frequency heart rate variability (HF-HRV). Three groups of dyads were discerned. The largest group (approximately 80%) demonstrated physiological attunement, with a stable and parallel regulatory pattern of HF-HRV from baseline to postneedle. The second group (7.9%) had parallel regulatory trajectories but with notably lower (ie, less regulated) HF-HRV values, which indicates independent regulatory responses (ie, a lack of attunement among dyad members). The third group (11.1%) showed diverging regulatory trajectories: Caregivers showed a stable regulatory trajectory, but toddlers demonstrated a steep decrease followed by an increase in HF-HRV values that surpassed their baseline levels by the third minute postneedle. Post hoc analyses with the HF-HRV groupings explored heart rate patterns and potential predictors. These findings elucidate potential adaptive and maladaptive co-regulatory parasympathetic patterns in an acute pain context.

Long short-term memory (LSTM) model-based reinforcement learning for nonlinear mass spring damper system control

The Neural Networks (NN) model which is incorporated in the control system design has been studied, and the results show better performance than the mathematical model approach. However, some studies consider that only offline NN model learning and does not use the online NN model learning directly on the control system. As a result, the controller's performance decreases due to changes in the system environment from time to time. The Reinforcement Learning (RL) method has been investigated intensively, especially Model-based RL (Mb-RL) to predict system dynamics. It has been investigated and performs well in making the system more robust to environmental changes by enabling online learning. This paper proposes online learning of local dynamics using the Mb-RL method by utilizing Long Short-Term Memory (LSTM) model. We consider Model Predictive Control (MPC) scheme as an agent of the Mb-RL method to control the regulatory trajectory objectives with a random shooting policy to search for the minimum objective function. A nonlinear Mass Spring Damper (NMSD) system with parameter-varying linear inertia is used to demonstrate the effectiveness of the proposed method. The simulation results show that the system can effectively control high-oscillating nonlinear systems with good performance.

Corporate Monitors: A Comparative Study

Corporate monitorship is a pretrial diversion mechanism that enables prosecutors to rehabilitate corporate offenders. The article examines the legal and regulatory trajectory of corporate monitors in the US, UK and a few other economies. The article documents that corporate monitors not only permitted the corporate offenders to settle criminal charges with law compliance, but also helped to reduce the number of future violations. The article argues that the regulatory framework for corporate monitorship tends to rely upon principle-based judicial rules and the supplementing procedural guidelines. These guidelines often focus on the internal and external supervisory measures on the appointment of corporate monitors. Our research also presents an evidence-based, preliminary assessment of selected pilot schemes on corporate monitorship carried out at sub-national levels in China. It proceeds to make policy recommendations drawn from our comparative survey of corporate monitors. These include allocating greater prosecutorial discretion in regard to the use of corporate monitors in criminal proceedings, addressing the legislative inconsistencies of corporate monitorship with the existing PRC criminal justice system, and enhancing inter-agency coordination in respect of corporate monitors.

Recommender Systems in the EU: from Responsibility to Regulation

Over recent years, the EU has increasingly looked at the regulation of various forms of automation and the use of algorithms. For recommender systems specifically, two recent legislative proposals by the European Commission, the Digital Services Act from December 2020 and the Artificial Intelligence Act from April 2021, are of interest. This article analyses the recent legislative proposals with a view to identify the regulatory trajectory. Whereas the instruments differ in scope, it argues that both may -directly and indirectly- regulate various aspects of recommender systems and thereby influence the debate on how to ensure responsible, not opaque, machines that recommend information to humans.

Macao Gaming Concession System: Present and Future Direction

Macao gaming concession is about to expire in June 2022, and such issues as the number of concessions and contract period have attracted much attention. This article introduces the evolution of Macao gaming system with emphasis on its concession duration, legal limit on the number of concessions, asset disposal and tax rate. As a result of its gaming liberalization, Macao has developed into the world’s casino capital. The gaming situation in Macao and in the gaming jurisdictions nearby is different from what it was twenty years ago. Although the current law requires a new public tender for awarding concessions, the increased number of gaming jurisdictions to target Macao would entail adjustment in its public policies to keep its gaming industry competitive. Additionally, the evolution of the relevant public policies and their interactions with touristic, infrastructural, environmental and urban planning policies would likely lead to some changes in the core of the current Macao gaming legislation. The authors indicated that the emergence of subconcessions and satellite casinos, the fractioning of spaces and utilities by different entities regarding asset reversion to the government, and the relationship between concessionaires and junket operators are some major issues, which require an improved legal framework designed to react expeditiously and effectively to the fast-moving industry for a sustained and consistent upward regulatory trajectory. Following this, revising and improving the current concession model would be crucial, even though it implies changes to the core of the current Macao gaming legislation.

Regulating Corporate Social Responsibility (CSR) for Economic and Social Development Through Trade Rules

Multinationals affirm corporate social responsibility (CSR) is a way to go further than national and international law to build a social compact. While CSR can contribute to an effective global labor governance scheme, we argue that national and international laws must be engaged to regulate CSR private governance schemes. We will support this argument and, furthermore, we will argue that international trade agreements can provide, if effectively enforced, grounds for the articulation. It can be argued that hybrid governance schemes could ensure that result-oriented and pragmatic developmental processes are at the core of the CSR–development nexus. In this article, we argue for the need to socialize CSR to make it more efficient, and that trade agreements can be part of this process. CSR is not an autonomous regulatory trajectory, and it will probably become increasingly regulated through institutional means.

Genomic susceptibility in practice: The regulatory trajectory of non-rare thrombophilia (NRT) genetic tests in the clinical management of venous thrombo-embolism (VTE)

The use of individual genomic risk factors to predict the onset of common diseases is one of the main promises of personalized medicine. This paper aims to contribute to the understanding of how genetic susceptibility shapes clinical practice, by drawing on non-rare thrombophilia (NRT) tests, a common diagnostic technique for congenital predisposition to venous thromboembolism (VTE).Adopting a diachronic approach, we describe the trajectory of NRT usage and its professional regulation since the discovery of NRT variants in the mid-90s. Empirical materials combine biomedical literature, guidelines and recommendations, and interviews with key actors. We show a rapid adoption of these tests by clinicians, followed by a controversy over their clinical utility after epidemiological evaluations of NRT test demonstrated a low capacity to predict VTE in individual carriers. Indeed, alternative views on what should count as clinical utility led to heterogeneous professional regulations. Some clinicians favoured statistical and individualized predictions of risk and proposed a cessation of test prescription in the management of VTE. Others praised the context-specific clinical values of the tests that integrated their connection with aetiology and implications for prevention in healthy relatives, and therefore adopted less stringent regulatory principles. We identify three features of these genetic susceptibility tests that are central in this regulatory trajectory: two epistemological interpretations of the tests - as a molecular determinant of disease and as a multifactorial risk factor for VTE - that are alternatively aligned or opposed to each other; the connections established between different clinical contexts through test use and the correlated possibility of proposing preventive actions “for relatives; the centrality of the tests” in various clinical contexts regarding decisions about pharmacological treatment.

Acervo acadêmico das IES pertencentes ao sistema federal de ensino: manutenção, guarda e conversão para o meio digital conforme a legislação brasileira

Em 2017, o governo brasileiro publicou dois dispositivos legais voltados à gestão dos acervos acadêmicos dos cursos superiores de graduação e de pós-graduação lato sensu das instituições de educação superior (IES) pertencentes ao sistema federal de ensino: o Decreto nº 9.235, de 15 de dezembro de 2017 e a Portaria nº 22 do Ministério da Educação (MEC), de 21 de dezembro de 2017. Em 2018 esta portaria foi revogada pela Portaria nº 315 MEC, de 4 de abril de 2018, publicada paralelamente à Portaria nº 330 MEC, de 5 de abril de 2018, que dispõe sobre a emissão de diplomas em formato digital. A pesquisa discorre sobre a trajetória de regulamentação e os procedimentos para manutenção, guarda e conversão do acervo acadêmico das IES pertencentes ao sistema federal de ensino para o meio digital, por meio do contraponto das normativas do MEC com a legislação arquivística nacional, especialmente as recomendações emanadas pelo Conselho Nacional de Arquivos (Conarq). Nesse sentido, constata-se que o governo brasileiro vem incentivando a informatização dos acervos acadêmicos através da digitalização dos documentos, e também por meio da produção de documentos nato digitais, como é o caso da expedição do diploma digital e documentação correlata. Assim, considera-se que as IES devem implantar políticas de gestão para os documentos arquivísticos e observar as demais legislações, sobretudo as diretrizes e recomendações do Conarq, que não foram contempladas nos recentes regulamentos do acervo acadêmico, para que a produção e a preservação dos documentos que o compõem estejam amparados legalmente e sejam acessíveis no longo prazo.

Yeomans, H.Alcohol and Moral Regulation: Public Attitudes, Spirited Measures and Victorian Hangovers. Policy Press. 2014. 279 pp. $115.83 (CAD) (hardcover) ISBN 1447309936

Once upon a time, alcohol use in Britain was construed by many as a destructive force that led to the disintegration of families, disarray in the workplace, unemployment and crime. To combat these issues, legal frameworks were enforced to regulate its use and create social order. Henry Yeomans provides a socio-historical analysis of Britain's relationship with alcohol and the public's attitude towards it in his book, Alcohol and moral regulation: Public attitudes, spirited measures and Victorian hangovers (2014). His book is a much-welcomed contribution to the fields of critical sociological theory, and media studies. For those unfamiliar with the differences in drinking cultures, values and attitudes in the West, Yeomans book provides a comprehensive account of the values ascribed to alcohol and particular drinking patterns in Britain, with frequent comparisons to other European nations. Employing a qualitative discursive methodology, Yeomans reports on a wide-ranging media analysis of popular print sources in Britain circa 18th century onwards. By tracing Britain's history with alcohol, Yeomans paints a vivid picture of the different ways in which alcohol, and its use has been vilified, moralised and regulated over the years. His analysis of alcohol's regulatory trajectory succinctly tracks the changes in values attached to alcohol use, and aptly shows the fluctuating relationship that exists between alcohol and the British people. One of Yeomans central arguments concerns contemporary attitudes about alcohol use. He argues that modern day angst about alcohol use, and drinking patterns more generally is not new to British society, but in fact is a ‘hangover’ from the Victorian era, more specifically, the temperance movement. Similarly, Yeomans asserts that contemporary measures of drinking regulation in England and Wales have their roots in 18th century regulatory practices. His analysis provides a complex dissection of the socio-political, economic and gendered contexts in which alcohol's regulatory practices were birthed and have since thrived. Yeomans’ central arguments are situated around the term moral regulation, a concept he thoroughly dissects in Chapter 1 of the book. Other key concepts that are theoretically untangled in this chapter include terms such morality, and moral panic. Alcohol and moral regulation contains eight chapters, each capturing specific time periods and their associated regulatory frameworks. In the first half of the book (Chapters 2–4), Yeomans continues to tease apart what he means by the term ‘moral regulation’ and situates its place within 18th and 19th century regulatory practices and developments. The second half of the book (Chapters 5–8) examines the regulatory practices during the First and Second World War, and notably, the decline of the temperance movement. They also examine the impact of age and gender as contributors to the ‘drink problem.’ These later chapters show that despite attempts to deregulate and liberalise alcohol, strict regulations were imposed that targeted the drinking patterns and behaviours of particular groups. Alcohol and moral regulation dramatises the landscape for readers and paints a very vivid picture of key historical moments in the construction of Britain's ‘drink problem’. Drawing on a rich tradition of thought in moral psychology, and philosophy, Yeomans mobilises the concept of moral regulation to showcase the moral policing of the use of alcohol. He provides readers with a compelling and conceptually astute reading of moral regulation and does an excellent job of calling attention to the alarmist frames used to report the ‘drink problem.’ In his historical account, Yeomans teases apart the actual threat posed by alcohol consumption versus what has been portrayed to date, and the levels of public anxiety about it. His work provides deep background and encourages readers to reflect on and question dominant alarmist narratives perpetuated in the media. This book is an integral starting point for any reader interested in a critical analysis of British media portrayal of public attitudes towards alcohol. More specifically, it would appeal to an interdisciplinary audience (sociologists, media scholars, historians, legal scholars etc.) interested in a historical approach to alcohol studies.

The On-Demand Work (Mis)classification Judgments in Italy. An Overview

After a brief recap of the Italian legal framework in matter of employment subordination, the A. analyzes the three Judgments of the Italian Courts concerning the classification of on-demand work. The A. underlines the complexity of the classification of the new forms of work through the traditional criteria of interpretations, but he also criticizes the initiative of the Italian Legislator, which, passing article 2 Decreto Legislativo No. 81/2015, traced a doubtful boundary between the direction of work (still the essence of employment subordination) and the organization of other’s work (a feature which should lead to the application of employment standards without losing the nature of independent contractor). Ultimately, the A. contends that the burden of finding an adequate response to the social needs of on-demand workers cannot be placed (entirely) upon the Courts, since it is a matter of policy (action) at large. Accordingly, he weights and eventually endorses the regulatory trajectory of conferring upon – certainly vulnerable, regardless of their classification as employees or independent contractors – on-demand workers a bundle of selected protections, through a “ad hoc” statute and/or via collective bargaining.

An experimental design framework for Markovian gene regulatory networks under stationary control policy

BackgroundA fundamental problem for translational genomics is to find optimal therapies based on gene regulatory intervention. Dynamic intervention involves a control policy that optimally reduces a cost function based on phenotype by externally altering the state of the network over time. When a gene regulatory network (GRN) model is fully known, the problem is addressed using classical dynamic programming based on the Markov chain associated with the network. When the network is uncertain, a Bayesian framework can be applied, where policy optimality is with respect to both the dynamical objective and the uncertainty, as characterized by a prior distribution. In the presence of uncertainty, it is of great practical interest to develop an experimental design strategy and thereby select experiments that optimally reduce a measure of uncertainty.ResultsIn this paper, we employ mean objective cost of uncertainty (MOCU), which quantifies uncertainty based on the degree to which uncertainty degrades the operational objective, that being the cost owing to undesirable phenotypes. We assume that a number of conditional probabilities characterizing regulatory relationships among genes are unknown in the Markovian GRN. In sum, there is a prior distribution which can be updated to a posterior distribution by observing a regulatory trajectory, and an optimal control policy, known as an “intrinsically Bayesian robust” (IBR) policy. To obtain a better IBR policy, we select an experiment that minimizes the MOCU remaining after applying its output to the network. At this point, we can either stop and find the resulting IBR policy or proceed to determine more unknown conditional probabilities via regulatory observation and find the IBR policy from the resulting posterior distribution. For sequential experimental design this entire process is iterated. Owing to the computational complexity of experimental design, which requires computation of many potential IBR policies, we implement an approximate method utilizing mean first passage times (MFPTs) – but only in experimental design, the final policy being an IBR policy.ConclusionsComprehensive performance analysis based on extensive simulations on synthetic and real GRNs demonstrate the efficacy of the proposed method, including the accuracy and computational advantage of the approximate MFPT-based design.

Regulating the private rented sector: millennial themes

PurposeThis paper considers the evolution of government policies regarding the provision of housing in the private rented sector and the regulation of landlord behaviour by mapping this onto known regulatory theory. It argues that the current regulatory trajectory is highly problematic both from the perspective of land law (by further attenuating the conception of property rights) and indeed regulatory compliance.Design/methodology/approachThe approach maps successive governments’ policy stance, what is known of the configuration of the sector and the current demand for housing against evolving regulatory theory (in particular compliance). The piece draws on both property theory and economic analysis.FindingsEnrolling private sector landlords to enforce policies, other than those relating to the landlord and tenant relation (as indicated by the “right to rent” provisions), and attempts at professionalizing the sector may be highly problematic. Furthermore, the growth of regulation may impose an increasing regulatory burden on a significant proportion of the sector, namely, the smaller landlord especially those owning who own only one property.Research limitations/implicationsThe hypothesis has not been tested aside in a generalized manner by making reference to the evidence obtained by other researchers and landlord associations. It is for other researchers who may wish to test the hypothesis empirically.Practical implicationsThis paper includes a view that has not (to the author’s knowledge) been expressly articulated by Government or through its policies and is one which it may wish to reflect upon.Originality/valueThis paper adopts a novel stance by deploying regulatory theory with understandings of property to highlight potential adverse effects.

Lost in translation? Accountability and governance of clinical stem cell research in China.

Despite China's regulatory initiatives to promote its research accountability, it still needs to prove itself as a trusted player in life science research. In addition, in contrast to its huge investment, China is losing the race in delivering quality application of stem cells. The trial implementation of the 2015ministerial regulations seemed to offer hope in ending this dual 'lost-in-translation'. Yet skepticism remains. By examining China's regulatory trajectory in the last 15years, this paper illustrates that it is a post hoc pragmatic policy rationale and a soft centralization regulatory approach that have hampered China's governance. To improve China's governance of accountability, policy-makers need to get beyond an 'act-in-response' regulatory ethos and to engage with diverse stakeholders.

Effective indoor air quality for energy-efficient homes: a comparison of UK rating systems

The use of sustainable assessment methods in the UK is on the rise, anticipating the future regulatory trajectory towards zero carbon by 2016. The indisputable influence of sustainable rating tools on UK building regulations conveys the importance of evaluating their effectiveness in achieving true sustainable design, without adversely effecting human health and well-being. This paper reviews indoor air-quality (IAQ) issues addressed by UK sustainable assessment tools, and the potential trade-offs between building energy conservation and IAQ. The barriers to effective adoption of IAQ strategies are investigated, including recommendations, suggestions, and future research needs. The review identified a fundamental lack of IAQ criteria in sustainable assessment tools aimed at the residential sector. The consideration of occupants’ health and well-being should be paramount in any assessment scheme, and should not be overshadowed or obscured by the drive towards energy efficiency. A balance is essential.

IVF policy and global/local politics: The making of multiple-embryo transfer regulation in Taiwan

This paper analyzes the regulatory trajectory of multiple-embryo transfer in in-vitro fertilization (IVF) in Taiwan. Taking a latecomer to policy-making as the case, it argues the importance of conceptualizing the global/local dynamics in policy-making for assisted reproductive technology (ART). The conceptual framework is built upon recent literature on standardization, science policy, and global assemblage. I propose three interrelated features that reveal the “global in the local”: (1) the power relationships among stakeholders, (2) the selected global form that involved actors drew upon, and (3) the re-contextualized assemblage made of local networks. Data included archives, interviews, and participant observation. In different historical periods the specific stakeholders selected different preferred global forms for Taiwan, such as Britain’s code of ethics in the 1990s, the American guideline in the early 2000s, and the European trend in the mid-2000s. The global is heterogeneous. The failure to transfer the British regulation, the revision of the American guideline by adding one more embryo than it specified, and the gap between the cited European trend and the “no more than four” in Taiwan’s 2007 Human Reproduction Law all show that the local network further transforms the selected global form, confining it to rhetoric only or tailoring it to local needs. Overall, Taiwanese practitioners successfully maintained their medical autonomy to build a ‘flexible standardization’. Multiple pregnancy remains the most common health risk of IVF in Taiwan.

Biosimilars: Impact of Biologic Product Life Cycle and European Experience on the Regulatory Trajectory in the United States

BackgroundBiosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences between the biologic product and the reference product in terms of safety profile, purity, and potency. Due to the high cost of innovator biologics, as well as an increase in the number of these products reaching patent expiry, the development of a process for approving biosimilar products has become a crucial regulatory issue in the United States. ObjectiveThis commentary explores the relationship between structural/biophysical variation and the risk/benefit profile of biosimilars and reference biologics that have undergone process changes in the context of the most recent biophysical, nonclinical, and clinical data available. MethodsThe search strategy used PubMed, EMBASE, and MEDLINE for the retrieval of documents pertaining to biologic manufacturing, comparative analysis of biosimilars and originator biologics, and relevant review articles on biosimilars. For regulatory documents pertaining to the processes of the approval of biosimilars, biologics, and generics, a search for legislative decisions, briefing summaries, concept papers, guidance, and evaluations of approved and rejected applications for biosimilars published by the World Health Organization, US Food and Drug Administration, European Medicines Agency (EMA), and other national regulatory authorities was conducted. Selected articles from key opinion leaders and manufacturers were also reviewed. These searches were conducted to provide a review of historical and contemporary issues in the consideration of the current status of worldwide biosimilar use and regulation. ResultsA total of 18 marketing applications covering 9 development programs were surveyed. Of these, 14 applications were approved and 4 were rejected by the EMA. None of the biosimilars were reported to have evidence of significant clinical variation relative to reference compounds in the absence of corresponding differences in biophysical properties. A single biosimilar (Omnitrope® [somatropin]) was reported to have evidence of significant variation in both biophysical and clinical parameters in premarketing studies. Biophysical variation in the absence of relevant differences in the efficacy and safety profiles compared with the reference brands was noted for 2 biosimilar epoetin products. ConclusionsThis commentary provides evidence that current EU guidelines have resulted in the approval of biosimilar therapeutics with comparable efficacy and safety profiles for the recommended indications of their respective reference originator biologics. It is anticipated that these precedents will serve as a starting point in the development of a process for approving biosimilars in the United States and worldwide to provide efficacious and tolerable biotherapeutics with a significant cost advantage for national health care programs and consumers.

Current and Future Regulation Challenges for the Chinese Telecommunications Sector

Current and Future Regulation Challenges for the Chinese Telecommunications Sector

Current and Future Regulation Challenges for the Chinese Telecommunications Sector

For Chinese telephony, the new restructuring scheme – designed to boost efficiency and create three full-serviceoperators is completed by the end 2008. This paper studies the regulatory trajectory of the telecommunicationsindustry in China. Different stages of the regulation process with policy intervention and market competition areexamined. The interaction of different players like the Chinese government, incumbent operator, and competitiveoperator is analyzed. In the paper, two general theories of regulation, public interest theory and the economictheory of regulation are firstly introduced. Theses literatures are later used to explain the current regulatoryparticularities of Chinese telephony.