Regulatory Innovation Research Articles

Policymakers Take Notice of Bioeconomy's Potential

Policymakers Take Notice of Bioeconomy's Potential

States as platforms following the new EU regulations on online platforms

The recent adoption by the European Parliament of the Digital Services Act means that, when it comes into effect, it will formally introduce into EU law the term ‘online platforms’. In effect, between the Digital Services Act and the Digital Markets Act, a comprehensive framework for the regulation of online platforms is being introduced into EU law, the first of its kind both in Europe and internationally. However, European regulatory innovation invites a different viewpoint: Could states be considered platforms? What if this new regulatory framework was applied to states themselves? This article first outlines the regulations on online platforms in EU law. Then it discusses the role of states as information brokers in order to support its main argument, that states can be viewed as (online) platforms. A discussion of the consequences of such a conclusion is included in the final part of this analysis.

ФІНАНСОВО-ЕКОНОМІЧНІ ПРОЦЕСИ В УКРАЇНІ В УМОВАХ ВОЄННОГО СТАНУ

The decision to introduce martial law becomes a kind of lever for changes in the state regulation of financial and economic processes. The introduction of martial law for the economy means an additional concentration of all existing financial and non-financial resources in the country on programs of financial and economic protection of the country. And it is absolutely logical to expect a review of the state budget, reduction of all programs aimed at non-defense purposes - medicine, education, increase of pensions, minimum wages, etc. It was noted that today the domestic economy is increasingly becoming one of the priority fronts, which will determine both the further course of military operations and the ability of our country to successfully rebuild after their end, the key to success is to a large extent the ability of managers at various levels to form effective and efficient strategic plans and ensure the effectiveness of their practical implementation, including the timely implementation of outlined applied tasks and management of financial and economic processes. But without adequate actions on the part of the authorities, which will consist in the implementation of appropriate instruments of economic policy, the significant potential of the post-war revival may be leveled. Considering the above, we can observe that the government has already urgently introduced a number of important regulatory innovations designed to reduce the fiscal burden on business and stimulate the development of small entrepreneurship. In addition, a certain liberalization of the legislation took place. The outlined measures for economic liberalization show that the government is clearly aware of the direct relationship that exists between the degree of economic freedom and the pace of economic development. Moreover, it should be noted and even emphasized that the initiated changes should not only continue, but also intensify in the post-war period. Therefore, it is already necessary to form a strategy for the post-war economic development of Ukraine, focused on its maximum deregulation and demonopolization. It is necessary to maintain and develop the initiated course to minimize the regulatory influence of power institutions on the operational functioning of the economy.

Is regulatory innovation fit for purpose? A case study of adaptive regulation for advanced biotherapeutics

AbstractThe need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in‐depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis‐à‐vis their stated goals and objectives.

Prenatal Somatic Cell Gene Therapies: Charting a Path Toward Clinical Applications (Proceedings of the CERSI-FDA Meeting).

We are living in a golden age of medicine in which the availability of prenatal diagnosis, fetal therapy, and gene therapy/editing make it theoretically possible to repair almost any defect in the genetic code. Furthermore, the ability to diagnose genetic disorders before birth and the presence of established surgical techniques enable these therapies to be delivered safely to the fetus. Prenatal therapies are generally used in the second or early third trimester for severe, life-threatening disorders for which there is a clear rationale for intervening before birth. While there has been promising work for prenatal gene therapy in preclinical models, the path to a clinical prenatal gene therapy approach is complex. We recently held a conference with the University of California, San Francisco-Stanford Center of Excellence in Regulatory Science and Innovation, researchers, patient advocates, regulatory (members of the Food and Drug Administration), and other stakeholders to review the scientific background and rationale for prenatal somatic cell gene therapy for severe monogenic diseases and initiate a dialogue toward a safe regulatory path for phase 1 clinical trials. This review represents a summary of the considerations and discussions from these conversations.

지역 민간 주택공급자 활성화 방안

Currently, the Yoon Seok-yeol government has presented four tasks: ① expanding housing supply, realizing housing stability through market function recovery, ② normalizing the real estate tax system for stable housing, ③ improving the housing finance system for stable housing, and ④ supporting strong housing welfare in the 110 state projects announced on May 3. As can be seen from the 110th task, the new government puts real estate stability through the expansion of housing supply as its first task, while emphasizing regulatory innovation as one of the biggest tasks of the new government, stressing that "all ministries will actively rationalize regulations to maximize private capabilities and function properly." In the end, the new government is expected to ease regulations such as improving the three rental laws, easing the comprehensive real estate tax and capital gains tax system for multiple homeowners, and streamlining loan regulations to implement the top task of expanding housing supply. Therefore, this study intends to present a plan to expand housing supply led by the private sector and revitalize housing suppliers through an overview of the laws and policies related to housing supply.

Institutional Voids and Entrepreneurial Responses to a Societal Crisis

This paper assesses how societal disruptions lead to collective action that addresses institutional voids. Examining field data from Sweden’s response to the Covid-19 outbreak, we track institutional voids related to four product market categories. We construct a process model and elaborate on what we conceptualize as entrepreneurial constellations, which consist of collaborating business firms, public organizations, and the government. These entrepreneurial constellations facilitate the functioning of markets or forming of new ones to deal with a disruption. Through collective action, constellations coordinate problems and self-interest to overcome regulatory obstacles. Findings point to institutional voids that relate to surges during the need to scale up existing critical product markets, creating and innovating new critical product markets. Recognizing such institutional voids helps constellations coordinate expertise that collectively enacts regulatory changes and innovation in coordinative functions. While emerging, they accomplish ongoing evaluative reflections that permit them to autocorrect. This new conceptual understanding of the surprising presence and consequences of institutional voids in market economies, where they are not expected to develop and cause insufficiencies and suffering, explains how entrepreneurial constellations improvise solutions to societal disruptions.

Motivated to Fight Climate Change? How TMT Regulatory Focus Shapes Green Innovation in Family Firms

Facing trends of environmental regulations and environmental consciousness, firms need to engage in green innovation. Particularly important for family firms, green innovation helps firms to achieve sustainable competitive advantage, fostering long-term firm survival. Yet, we still lack theoretical evidence on how motivational characteristics of the top management team (TMT) (i.e., regulatory focus) relate to green innovation. Drawing on upper echelons and regulatory focus theory, we examine the relationship between TMT regulatory focus and green innovation. We further posit that family involvement and technological turbulence moderate this relationship. Analyzing a longitudinal panel dataset with 910 firm-year observations of 116 S&P 500 family firms between 2005 and 2018, we find that TMT promotion and prevention focus are positively associated with green innovation. Family involvement positively moderates the relationship between TMT promotion focus and green innovation but does not moderate the relationship between TMT prevention focus and green innovation. In addition, technological turbulence positively (negatively) moderates the relationship between TMT promotion (prevention) focus and green innovation. This study expands research on upper echelons and regulatory focus theory by showing that psychological characteristics of TMTs (i.e., regulatory focus) determine firm-level outcomes (i.e., green innovation) in family firms, linking regulatory focus theory to the TMT.

Inside the UK’s brave new world of ATMP regulatory innovation

Jacqueline Barry is the Chief Clinical Officer, responsible for Clinical Translation and Delivery activities and an Executive Director of the Cell and Gene Therapy Catapult. She has extensive experience in the development of advanced therapy medicinal products and leads a multi-disciplinary team of Nonclinical, Regulatory, Clinical Operations and Programme Management specialists. She also leads the coordination of the UK Advanced Therapy Treatment Centre Network and is a Director of the Global Alliance for iPSC Therapies. She feels passionately about making advanced therapies available for patients and works closely with the MHRA and the NHS on the development of the ecosystems to support the adoption of these therapies. Prior her time at Cell and Gene Therapy Catapult, Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release. She has a PhD from the University of Aberdeen and did post-doctoral research in neurophysiology at the University of Edinburgh.

Are the Current Processes and Regulations Fit for Purpose to Deliver Novel Therapies During Pandemics? A Perspective on COVID-19 from the UK.

The COVID-19 pandemic was the first ‘stress test’ to assess whether the current regulations in the United Kingdom (UK) are fit for purpose to develop novel therapies during pandemics. It saw innovations and collaborations across the spectrum of the drug development and regulatory pathways, including extraordinary collaborations between the various stakeholders involved in the process, the repositioning of medicines, the deployment of multi-arm, multi-interventional adaptive trials, the institution of operational simplicity and flexibility across various trial activities, and regulatory innovations. The question arises whether the innovative flexibilities and the urgency that were instituted could have resulted in compromises to the integrity of the process. An assessment of the conduct of the RECOVERY trial and the speedy approval of dexamethasone by the UK Medicines and Healthcare products Regulatory Agency demonstrates that no compromises were made to the ethical and scientific integrity of the process. Lessons learnt could be applied for future pandemics and to enhance R&D productivity and contribute to global health by improving access to medicines, especially in low- and middle-income countries and for neglected or rare diseases. What is needed is not a major transformation in the process but the flexible adaptation of existing regulations to reduce bureaucracy and handover times. Arriving at an optimal balance between scientific standards, regulations and commercial conflicts of interest will pose considerable challenges but what the COVID-19 pandemic has shown is that where there is will, there is always a way.

Analysis of Digital Infrastructure Development for the Indonesian Capital Market

Digital developments in the Indonesian capital market are influenced by regulatory policies and innovations carried out on an ongoing basis by Exchange Members (AB). In responding to the development of the digital economy, the government must be able to create policies such as ease of financing for startups, tax incentives, and fostering mastery of information and communication technology (ICT) for SMEs. The government also needs to develop telecommunications infrastructure and develop ICT education. Community participation to improve education and skills in the field of ICT also needs to be done in order to take advantage of existing opportunities for their welfare. So to succeed (survive) in this dynamic world, companies should not only perform traditional actions such as lowering costs, but also undertake activities such as changing innovation structures or processes as critical response activities. Most of the response activities could be better facilitated by Information technology.

Legal, Regulatory, and Governance Innovation in Transnational Environmental Law

Legal, Regulatory, and Governance Innovation in Transnational Environmental Law

Parental legacy versus regulatory innovation in salt stress responsiveness of allopolyploid cotton (Gossypium) species.

SUMMARYPolyploidy provides an opportunity for evolutionary innovation and species diversification, especially under stressful conditions. In allopolyploids, the conditional dynamics of homoeologous gene expression can be either inherited from ancestral states pre‐existing in the parental diploids or novel upon polyploidization, the latter potentially permitting a wider range of phenotypic responses to stresses. To gain insight into regulatory mechanisms underlying the diversity of salt resistance in Gossypium species, we compared global transcriptomic responses to modest salinity stress in two allotetraploid (AD‐genome) cotton species, Gossypium hirsutum and G. mustelinum, relative to their model diploid progenitors (A‐genome and D‐genome). Multivariate and pairwise analyses of salt‐responsive changes revealed a profound alteration of gene expression for about one third of the transcriptome. Transcriptional responses and associated functional implications of salt acclimation varied across species, as did species‐specific coexpression modules among species and ploidy levels. Salt responsiveness in both allopolyploids was strongly biased toward the D‐genome progenitor. A much lower level of transgressive downregulation was observed in the more salt‐tolerant G. mustelinum than in the less tolerant G. hirsutum. By disentangling inherited effects from evolved responses, we show that expression biases that are not conditional upon salt stress approximately equally reflect parental legacy and regulatory novelty upon allopolyploidization, whereas stress‐responsive biases are predominantly novel, or evolved, in allopolyploids. Overall, our work suggests that allopolyploid cottons acquired a wide range of stress response flexibility relative to their diploid ancestors, most likely mediated by complex suites of duplicated genes and regulatory factors.

The influence of changes in the organization of medical care on the indicators of mental disorders in children

AIM: This study aimed to assess the relationship between regulatory innovation strategy for changing the organization of medical care in children and adolescents and the dynamics of the incidence of mental and behavioral disorders in children aged 014 years.
 MATERIAL AND METHODS: The rate of chronicity was calculated as the ratio of the primary morbidity to the overall morbidity of mental and behavioral disorders. The presence of outliers (anomalous observations) in the series was determined using Irwins method, with n=11, cr=1.3. Mathematical apparatus: for the three analyzed series (primary, general morbidity, and chronicity coefficient), three mathematical models were built: one one-dimensional model and two with the introduction of dummy variables for orders No. 1346, No. 72n, No. 216n and order No. 1687n). The statistics of fit was compared between the one- dimensional model and each of the four models with dummy variables for the corresponding series. Moreover, their logarithmic values were used to reduce the variance of the series. Significance was assessed at p 0.05.
 RESULTS: Evaluation of the analyzed series for the presence of anomalous observations revealed a similar trend in the Arkhangelsk region and NorthWest Federal District. In all regions, except for the Russian Federation, emissions were concentrated from 2015 to 2017. In 2010, national analysis revealed only one anomalous observation. Graphical analysis and analysis by Irwins method revealed similar trends with regard to abnormal observations of the dynamics of the coefficient of chronicity in the Arkhangelsk region and Northwestern Federal District, which confirmed the previously established dynamic trends in the general and primary morbidity in children aged 014 years. In addition, after 2015, the dynamic changes were most pronounced in the Arkhangelsk region.
 CONCLUSIONS: No correlation was found among normative innovations for changing the organization of medical care among children and adolescents, changes in medical birth criteria, the dynamics of the incidence of mental disorders and behavioral disorders, indicators of the chronicity of this pathology in children aged 014 years, and mental and behavioral disorders in the Arkhangelsk region, Northwestern Federal District, and the Russian Federation in 20092019.

Developmental and evolutionary comparative analysis of a regulatory landscape in mouse and chicken.

ABSTRACTModifications in gene regulation are driving forces in the evolution of organisms. Part of these changes involve cis-regulatory elements (CREs), which contact their target genes through higher-order chromatin structures. However, how such architectures and variations in CREs contribute to transcriptional evolvability remains elusive. We use Hoxd genes as a paradigm for the emergence of regulatory innovations, as many relevant enhancers are located in a regulatory landscape highly conserved in amniotes. Here, we analysed their regulation in murine vibrissae and chicken feather primordia, two skin appendages expressing different Hoxd gene subsets, and compared the regulation of these genes in these appendages with that in the elongation of the posterior trunk. In the two former structures, distinct subsets of Hoxd genes are contacted by different lineage-specific enhancers, probably as a result of using an ancestral chromatin topology as an evolutionary playground, whereas the gene regulation that occurs in the mouse and chicken embryonic trunk partially relies on conserved CREs. A high proportion of these non-coding sequences active in the trunk have functionally diverged between species, suggesting that transcriptional robustness is maintained, despite considerable divergence in enhancer sequences.

From Prosperity to Deadlock: What’s Wrong with Financial Supervision on Robo-Advisors in China

Abstract Robo-advisors in China improved rapidly at beginning due to low market access standards and limited financial regulations. Since 2016, regulators worked out with various measures to promote the industry. However, statistics proved robo-advisory industry in China turned out to be less prosperous after that. Though it may result from complex reasons, one of which turns out to be a side effect of financial supervision. The research figures out risks for robo-advisors to breach compliance requirements and the dilemmas they are facing. Chinese regulators apply a financial inclusive strategy and penetrative supervision, but it impedes innovation to some extents. Judicialization of supervision is another problem. To solve this deadlock, making products more abundant may be the first step, and further legal steps should be adopted, such as advocating technology-driven regulatory innovation, making clear fiduciary duties, facilitating accurate supervision and risks prediction, and establishing a comprehensive regulatory structure.

Developmental mRNA m5C landscape and regulatory innovations of massive m5C modification of maternal mRNAs in animals

m5C is one of the longest-known RNA modifications, however, its developmental dynamics, functions, and evolution in mRNAs remain largely unknown. Here, we generate quantitative mRNA m5C maps at different stages of development in 6 vertebrate and invertebrate species and find convergent and unexpected massive methylation of maternal mRNAs mediated by NSUN2 and NSUN6. Using Drosophila as a model, we reveal that embryos lacking maternal mRNA m5C undergo cell cycle delays and fail to timely initiate maternal-to-zygotic transition, implying the functional importance of maternal mRNA m5C. From invertebrates to the lineage leading to humans, two waves of m5C regulatory innovations are observed: higher animals gain cis-directed NSUN2-mediated m5C sites at the 5' end of the mRNAs, accompanied by the emergence of more structured 5'UTR regions; humans gain thousands of trans-directed NSUN6-mediated m5C sites enriched in genes regulating the mitotic cell cycle. Collectively, our studies highlight the existence and regulatory innovations of a mechanism of early embryonic development and provide key resources for elucidating the role of mRNA m5C in biology and disease.

Shadow Rulemaking: Governing Regulatory Innovation in the EU Financial Markets – ERRATUM

Shadow Rulemaking: Governing Regulatory Innovation in the EU Financial Markets – ERRATUM

Retaining Influence in Post-Brexit International Financial Regulation: Lessons from the UK’s FinTech Framework

Abstract A common rhetoric has emerged among UK authorities when it comes to how to deal with a potential loss of influence in the regulation of financial services after Brexit: as divergence from the EU increases, it will be necessary to retain the UK’s influence as a rule maker through an enhanced engagement via international standard-setting bodies (ISSBs). This article argues that placing an excessive focus on the role of ISSBs to mitigate the UK’s loss of influence might be misguided, based on an analysis of the UK’s past relationship with these regulatory networks, alongside an assessment of their historical shortcomings and increasing limitations. Furthermore, this article advances the argument that the UK FinTech regulatory approach might serve as a successful complementary template for influence, combining a domestic framework with the development of a domestic-led network. For that purpose, this article compares initial responses to FinTech regulation at the UK, EU, and international levels, focusing on the Financial Conduct Authority’s regulatory sandbox and Global Financial Innovation Network to show how the UK’s regulatory ethos was effectively exported, constraining the options available to other countries while also framing the debate at the international level.

Paranoid regulatory innovations? Setting the stage for an unexpected war in Russian cities, 2021-2022

ABSTRACT This article examines the regulatory innovations and the way they were introduced by Russian federal authorities in the months leading up to the war in Ukraine. Following the standardization approach of the Soviet planning system, there was a rapid adoption of new and the modification of existing GOSTs. This article attempts to 1) trace and document how a hybrid regime state with a socialist planning heritage prepares the cities for war in the 21st century, and 2) propose an explanation for why the expert’s community has not reacted to such urgent policy changes.