Current Regulatory Approaches Research Articles

The design of retroviral vectors used in the CAR-T products, risk management, and future perspective.

Chimeric antigen receptor T-cell (CAR-T) therapy is a revolutionary approach in cancer treatment. More than 10 CAR-T products have already approved on market worldly wide, and they use either gamma retroviral vectors or lentiviral vectors to deliver the CAR gene. Both vectors have the ability to effectively and persistently integrate the CAR gene into T cells. Despite the advancements in CAR-T therapy, the potential risks associated with the vectors, particularly the risks of the secondary malignancies, still remain as a concern. This article compares the characteristics of gamma retroviral and lentiviral vectors, discusses the development of vector packaging systems, and examines the design of self-inactivating (SIN) vectors. It also addresses the risks of secondary malignancies that might possibly be associated with the retroviral vectors, and the strategies to decrease the risks and increase the safer clinical use of the vectors. This article also discusses the current regulatory landscape and management approaches aiming to mitigate these risks through stringent safety measures and ongoing monitoring. Future perspectives focus on improving the safety profiles of the vectors and broadening their scope of use. The article provides a thorough overview of the most recent research discoveries and regulatory updates in the field of CAR-T therapy, highlighting the significance of a balanced strategy that strikes a balance between innovation and patient safety in the development and implementation of CAR-T therapy.

Role of In Vitro Tests in the Characterisation of Locally Applied, Locally Acting Drugs in the Throat: Application to Flurbiprofen.

Background/Objectives: For locally applied, locally acting generic drug products, comparison to an originator product based on systemic exposure is usually not feasible due to low plasma concentrations and inadequate reflection of local exposure at the site of action. Where a validated PD model exists, a comparative clinical study can be performed in healthy subjects; where no surrogate endpoint is available, patients with the relevant indication need to be enrolled, with all the associated factors which could result in lack of sensitivity. Even though the need for alternative in vitro approaches has been acknowledged by both industry and regulatory bodies, the complexity of in vivo drug delivery processes makes the development of guidance documents particularly difficult. Our objective was to present in vitro approaches less classically used and to address in vivo relevance of the selected tests. Methods: This article analyses current regulatory approaches in Europe and the U.S., and highlights the key advantages of in vitro tests in terms of their sensitivity, reliability, reproducibility and in vivo relevance using locally applied flurbiprofen in various formulations. Results: The in vitro esophageal retention (IVOR) model demonstrates that the first 6-10 min after application of different flurbiprofen formulations is important for their comparison and also offers the best correlation with in vivo data using the partial area under the concentration-time curves (pAUCs). Rheological evaluations further demonstrated that the mucoadhesive properties of the gel spray formulation are based on interaction with mucin. Conclusions: Designing a relevant in vitro test requires adequate evaluation of the complexity of the drug substance, drug product, dosing conditions and delivery processes.

Disinfection Byproducts in Drinking Water from the Tap: Variability in Household Calculated Additive Toxicity (CAT).

Recent studies have implemented a calculated additive toxicity (CAT) approach that sums measured disinfection byproduct (DBP) concentrations weighted by their respective in vitro bioassay potencies to estimate their associated risk in disinfected waters. In this study, the CAT approach was used to systematically investigate 21 regulated and unregulated DBPs measured in drinking water at the household level. Water samples from the tap were collected from over 120 randomly selected participants supplied by eight public water systems using four distinct source water types, two types of disinfection processes, and across two seasons. The purpose of this study was to compare CAT using multiple biological end points, examine household variability, identify DBPs driving toxicity, and assess if current regulated DBPs are adequate predictors of unregulated DBPs. Our results support the significance of unregulated DBPs, particularly haloacetonitriles and iodoacetic acid, as drivers of toxicity. Simple linear models between regulated versus unregulated concentrations and CAT were overall weak with 67% considered poor (r 2 < 0.3). These results reveal that current regulatory monitoring approaches may not be adequately capturing true household exposure due to higher contribution of unregulated DBPs to CAT and poor predictability between regulated and unregulated DBP-mediated CAT.

The Climate Change Conundrum: A Case for Course Correction in the Global Regulatory Approach$

The Conference of Parties (COP) of the multilateral environmental agreements (MEAs) provides a platform at a specific periodicity (one, two or three years) to review work of the Convention in question. The UN Framework Convention on Climate Change (UNFCCC) is a ‘universal’ convention with 198 parties. The 28th annual meeting of the COP (UNFCCC) was held in Dubai (UAE) during 30 November - 13 December 2023. The UN provides ‘secretariat’ support to the UNFCCC, hence the usage of prefix ‘United Nations’. It is called a ‘framework convention’ since it was adopted with a bare skeleton on 09 May 1992. It required ‘fleshing out’ of the UNFCCC with required elements to make it work for the “‘ultimate objective” of “stabilization of greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system” (Article 2). It led to the adoption of the (“related legal instruments”) 1997 Kyoto Protocol and 2015 Paris Agreement. The climate change regime now comprises these three legal instruments that seek to address the global climate problematique. Whereas COP27 (Sharm El-Shaik; 06–21 November 2022) was known for adoption of the decision on “loss and damage” funding for vulnerable countries hit hard by climate disasters, COP28 unveiled the first global climate ‘stocktake’. This took place on the heels of UNEP Emissions Gap Report (20 November 2023) that issued warming that “world is heading for a temperature rise far above the Paris Agreement goals unless countries deliver more than they have promised”. The UNEP report called for the GHG emissions (by 2030) to “fall by 28 per cent for the Paris Agreement 2°C pathway and 42 per cent for the 1.5°C pathway”. Thus, there is a big chasm between what is laid down in the climate change regulatory framework, what is scientifically ordained and what is actually given effect on the ground by the states Parties. After 30 years (1994–2024), the resultant ‘conundrum’ presents a challenge at this juncture of planetary crisis. It calls for the state Parties to the global climate change regime to engage in a major course correction in the current global climate change regulatory approaches for securing our planetary future.

Идеология квалификации (аккредитации) инвесторов на фондовом рынке

Accreditation of investors is an unusual institution of civil and administrative law, since in fact one counterparty under a civil contract must make a quasi-administrative decision on the admission of another counterparty to civil transactions with itself and third parties, albeit based on the criteria provided by law. We discuss the first results of the investor accreditation reform that took place in Russia in 2020–2021. We have also summarised approaches to investor accreditation that have been developed in a number of foreign jurisdictions, with special attention paid to current Russian and American regulatory approaches and debates on these issues. We propose, taking into account a reasonable transition period, to completely switch to the qualification of investors only on the basis of an assessment of their real knowledge based on tests and professional certificates, as well as on paid personal income tax from stock transactions, abandoning all other qualification criteria. This will require, among other things, complete re-accreditation of all Russian retail investors. Testing should be carried out by organisations independent from brokers.

Don’t Call It a Failure: Systemic Risk Governance for Complex Financial Systems

The probability that an event will avalanche into an impairment of essential services constitutes a “systemic risk.” Owing to the inherent complexities of modern societies, the outbreak of a novel disease or the failure of a financial institution can rapidly escalate into an impact significantly larger than the initial event. Through the lens of complex system theory, this article draws a parallel between financial crises and disasters to contend that the regulatory framework for financial systemic risk is unequipped to address its fundamental dynamics. Epitomized by the market failure rationale, financial regulation is premised on a reductionist view that purports both systemic risk and law as external to the actions of market participants. Conversely, this article advances a twofold conceptual framework. First, it shows that systemic risk emerges from the same complex dynamics that generate the financial system. Second, it understands law as an agent of complexity, thus contributing to the emergence of finance and its inherent instability. Normatively, this conceptual framework reveals the limits of current regulatory approaches and constructs a holistic risk governance framework that is akin to the one adopted to govern disaster risks.

Regulatory Convergence in International Law: Evaluating Models of Global Economic Governance

This essay explores the intersection of international law and economic governance, focusing on the Regulatory Convergence Model as outlined by Daniel K. Tarullo. It examines the processes and challenges in international law-making, emphasizing the role of transnational regulatory standards in global economic governance. The discussion delves into issues of legitimacy and regulatory capture, critiquing the effectiveness of current regulatory approaches. The essay concludes by assessing the impact of these regulatory models on the stability of global financial markets, offering insights into the complexities of international economic regulation in a globalized world.

Implementing the human right to science in the regulatory governance of artificial intelligence in healthcare.

Artificial intelligence (AI) enables a medical device to optimize its performance through machine learning (ML), including the ability to learn from past experiences. In healthcare, ML is currently applied within controlled settings in devices to diagnose conditions like diabetic retinopathy without clinician input, for instance. In order to allow AI-based medical devices (AIMDs) to adapt actively to its data environment through ML, the current risk-based regulatory approaches are inadequate in facilitating this technological progression. Recent and innovative regulatory changes introduced to regulate AIMDs as a software, or 'software as a medical device' (SaMD), and the adoption of a total device/product-specific lifecycle approach (rather than one that is point-in-time) reflect a shift away from the strictly risk-based approach to one that is more collaborative and participatory in nature, and anticipatory in character. These features are better explained by a rights-based approach and consistent with the human right to science (HRS). With reference to the recent explication of the normative content of HRS by the Committee on Economic, Social and Cultural Rights of the United Nations, this paper explains why a rights-based approach that is centred on HRS could be a more effective response to the regulatory challenges posed by AIMDs. The paper also considers how such a rights-based approach could be implemented in the form of a regulatory network that draws on a 'common fund of knowledges' to formulate anticipatory responses to adaptive AIMDs. In essence, the HRS provides both the mandate and the obligation for states to ensure that regulatory governance of high connectivity AIMDs become increasingly collaborative and participatory in approach and pluralistic in substance.

Creation and application of artificial intelligence for public purposes: a comparative legal analysis.

The article focuses on a comparative analysis of existing approaches regarding the compliance of the artificial intelligence (AI) designed for public purposes in foreign countries and Russia with the current national strategies and regulatory approaches. As part of the study, the research identified the basic problems in the field of transparency in the decision-making of artificial intelligence, specified challenges to implicit regulatory nature for AI in the public sphere arising from the technical design of AI systems designed by developers; suggested theoretical and practical situations of using artificial intelligence that does not comply with the principles of designing AI on the basis of fundamental legal norms; and outlined possible compensatory legal measures that ensure the safe integration of artificial intelligence into the Russian public sphere. The subject of the study covers the issues of the influence of the design of artificial intelligence on its subsequent application in the public sphere. The object of the study focuses on the normative documents, recommendations and other documents regulating the issues of artificial intelligence preoccupation for public legal relations in Russia and foreign countries, judicial practice, academic publications and analytical reports on the issues under study. The research methodology integrates a complex of modern philosophical, general scientific, special scientific methods of cognition, including dialectical, systemic, structural-functional, hermeneutical, comparative legal, formal legal (dogmatic), etc. Within the framework of this study, special emphasis is placed on the implementation of a comparative legal study of the problems of designing artificial intelligence and its subsequent application within the public law field in the context of the problems inherent in the basic stage of creation. Subsequently, potential scenarios for regulating responsibility for AI actions are identified. The research has resulted in asset of measures that can be applied in the legislative and law enforcement practice of relevant authorities implementing the integration of artificial intelligence into the sphere of public relations in Russia, as well as in the scientific field in order to determine subsequent vectors for analyzing the minimization of AI bias as a result of incorrect technology design in violation of the basic legal structures.

Is Bangladesh’s policy response to the growing e-commerce sector compatible with its commitment to fight predicate offences for money laundering?

PurposeThis study aims to investigate Bangladesh’s e-commerce regulations in light of the growing criticism that they are insufficient to curb predicate crimes like fraud and money laundering in the online marketplace.Design/methodology/approachThis study used the exploratory design to examine the latest ministerial directives and laws governing e-commerce in Bangladesh to determine why they cannot prevent fraudulent activities in this promising sector and identify potential solutions.FindingsBangladesh’s regulatory responses to e-commerce fraud prevention and detection are reactive and inadequate. Regulators are unwilling and unable to enforce available legal provisions for various reasons, including a lack of knowledge and coordination among the agencies.Research limitations/implicationsThis paper focuses solely on the legal and regulatory framework in place to combat e-commerce fraud. Other critical issues, such as consumer rights, privacy and data protection in e-commerce, are not addressed.Practical implicationsThe findings of this study will assist policymakers in revising current regulatory approaches to e-commerce to protect this sector from criminal abuse.Originality/valueThis study looked into the possibility of using a proactive risk-based approach in the e-commerce sector, similar to what the Bangladesh Financial Intelligence Unit does in the financial sector.

Sustainable consumption in the digital age: A plea for a systemic policy approach to turn risks into opportunities

Digitalization offers opportunities for sustainable consumption patterns. However, the patterns enforced by present digital business models are not sustainable. Current European Union regulatory approaches for both consumers and environmental policies do not systematically address this challenge. By introducing “positive accountability,” we propose a systemic policy approach to hold digital companies accountable for their impact on consumers and the environment; supporting sustainable consumption in the digital age.

The Future of Dataveillance in Advertising Theory and Practice

Technological developments have changed the advertising landscape by extending the possibilities to collect, process, and share consumer data to optimize advertising. These developments have made data collection and consequently dataveillance—the automated, continuous, and sometimes unspecific collection, storage, and processing of digital traces—central concepts for advertising scholarship and practice. Studying the impact of consumers’ perceptions of dataveillance is important as perceptions about data collection practices have been shown to diminish the effects of data-driven advertising. This article advances advertising theory by conceptualizing the impact of consumers’ perceptions of dataveillance in digital data-driven advertising and applying long-standing advertising research theories to this new phenomenon to provide an overarching framework for future research. The current work presents the dataveillance effects in advertising landscape (DEAL) framework, with specific research directions for future research. This framework has practical implications as it shows how false or accurate beliefs about dataveillance impact consumer responses to digital data-driven advertising. Advertisers may adapt to ensure that digital data-driven advertising does not result in backlash or raise ethical questions. Finally, the framework has implications for privacy regulations, as consumer understanding of data collection is a core issue in current regulatory approaches to dataveillance.

African Data Protection Laws: Current Regulatory Approaches, Policy Initiatives, and the Way Forward

Data protection law is experiencing a global rise. Whilst setting the boundaries for public and private data processors, it has become a vital factor for individual protection and innovation alike. The quest for adequate data protection regimes is on-going, not only, but also on the African continent. Since 2001, the majority of African states have drafted and enacted data protection laws. Hard law and soft law instruments have been developed by the African Union and the African Regional Economic Communities. Regularly, EU-style legislation has been used as a source of inspiration – a process actively pushed for by the EU. Against this background, this study evaluates the current state of data protection law and data protection policy in Africa, questions the process of legal transplantation, and favours the consideration of a unique African approach to data protection. Thereby, this study is also a story about alternative routes to the General Data Protection Regulation (GDPR) which are – for many reasons – not easy to take. Africa, African Union, African Regional Economic Communities, Data Protection, Privacy, GDPR

Planning for Citizens’ Health: Towards an Integrated Approach to Air and Noise Pollution in the EU

Abstract The outbreak of covid-19 Pandemic has unfolded the close relationship between good environmental quality in urban areas and public health. The abrupt closure of economic activities through lockdown measures have shown how the concentration of air pollutants and noise from different sources are long-standing, major environmental and health issues in the European Union, especially in highly populated urban areas. Scientific evidence underscores that simultaneous exposure to air pollutants and noise constitutes a mutually reinforcing threat to human health. However, the current regulatory approaches in the European legislation still fall short in addressing the issues of air and noise pollution in a comprehensive and coordinated manner. The lack of harmonized and effective planning regime for air and noise pollution runs against the objectives pursued by the European Green Deal, whereas an effective and integrated response to environmental issues should underpin EU policies in the post Covid-19 recovery. This contribution thus analyzes two key EU legal regimes addressing air and noise pollution, namely Directive 2008/50/ec and Directive 2002/49/ec, respectively, to appraise their mutual pitfalls against the said need to adopt an integrated response to air and noise pollution. Moreover, the paper sheds further light on innovative approaches, such as integrated urban planning, citizen science and Internet of Things as key means to enhance cities’ resilience and support the implementation of effective legal responses to air and noise pollution.

Framing the nanny (state): an analysis of public submissions to a parliamentary inquiry on personal choice and community safety

ObjectiveTo examine public submissions to a parliamentary inquiry on personal choice and community safety, exploring framing used to support or oppose current public health regulatory approaches. MethodsDescriptive content analysis summarised the characteristics of electronic submissions. Framing analysis examined submissions according to the devices: problem and causes; principles and values; recommendations; data and evidence; and salience. ResultsWe categorised one hundred and five (n=105) submissions by source as Individual, Industry, Public Health and Other. Individuals made more than half the submissions. Overarching frames were choice and rights (Individuals); progress and freedom (Industry); protection and responsibility (Public Health). Most submissions opposed current regulations. Cycling, including mandatory helmet legislation, was most cited, with three‐quarters of submissions opposing current legislation. ConclusionsFraming analysis provided insights into policy actor agendas concerning government regulation. We found a high degree of resistance to public health regulation that curtails individual autonomy across various health issues. Investigating the influence of different frames on community perception of public health regulation is warranted. Implications for public healthAction is required to counteract ‘nanny state’ framing by industry and to problematise community understanding of the ‘nanny state’ in the context of balancing the public's liberties and the public's health.

Guidelines for Nanopharmaceutical Products for Regulatory Approval

The word 'nano' refers to a Greek prefix that means 'dwarf' or very little,' and represents a thousand millionth of a meter (10-9) in length. Nanoscience and nanotechnology are the study and application of nanoscale range materials. Initially, the term Nanotechnology was used by N. Taniguchi in 1974 at an international conference on industrial production in Tokyo to characterize the super-thin processing of materials with nanometre accuracy and the fabrication of nano-sized systems (Bayda S. et al., 2020). The usage of nanomaterials has enhanced the application of nanomedicine in various therapeutics area with challenges and limitations over the last ten years. Alteration of the physiochemical, biological, mechanical &amp; other properties of the materials made the nanomaterials and it can be utilized in different useful activities such as drug development, drug target. Nanotechnology utilized novel nanomaterials to make useful products. This technology has been used to overcome the limitations &amp; challenges in different drug therapies. (Harea JI et al., 2017). &#x0D; The combination of nanotechnology with pharmaceuticals and biomedicals is termed nano pharmaceutical. Nanopharmaceuticals is a new technology in current practice. As a result, there are no widely agreed nanopharmaceuticals guidelines. The general idea of regulatory requirements for Active Pharmaceutical Ingredients (API), as stated in the CDSCO's New Drugs and Clinical Trial Rules 2019, was mandatory in drug development pathways. These criteria are also in line with the International Council for Harmonization (ICH) recommendations and international standards that other countries using such items follow. New Drugs and Clinical Trials Rules, 2019 should be followed in different drug development. (Harea JI et al., 2017). &#x0D; Globally, there are important guidelines developed by the United States Food &amp; Drugs Administration (USFDA), International Council for Harmonization (ICH), or Organization for Economic Co-operation and Development (OECD). (Harea JI et al., 2017). &#x0D; Current regulatory approaches by US Food &amp; Drug Administration (FDA), established the nanotechnology task force in August 2006. This regulatory approach encourages the development of nanoproducts. FDA has issued the guidelines in 2007 to the industry to address the benefits &amp; risks of Drugs, medical devices, and other nanoproducts. FDA is also working with other U.S. government agencies to focus on the safety &amp; efficacy of nanoproducts and U.S. initiates the National Nanotechnology Initiative (NNI) which is a federal research &amp; development program to coordinate the effort of all government agencies involved in nanotechnology. The main goal of the NNI is to maintain the class of research &amp; development program, encourage inducing the new technologies in the product, developing the supporting infrastructure &amp; tools needed for nanotechnology (Ventola et al., 2012).

Datafication, Power and Control in Development: A Historical Perspective on the Perils and Longevity of Data

The collection, processing, storage and circulation of data are fundamental element of contemporary societies. While the positivistic literature on ‘data revolution’ finds it essential for improving development delivery, critical data studies stress the threats of datafication. In this article, we demonstrate that datafication has been happening continuously through history, driven by political and economic pressures. We use historical examples to show how resource and personal data were extracted, accumulated and commodified by colonial empires, national governments and trade organizations, and argue that similar extractive processes are a present-day threat in the Global South. We argue that the decoupling of earlier and current datafication processes obscures the underlying, complex power dynamics of datafication. Our historical perspective shows how, once aggregated, data may become imperishable and can be appropriated for problematic purposes in the long run by both public and private entities. Using historical case studies, we challenge the current regulatory approaches that view data as a commodity and frame it instead as a mobile, non-perishable, yet ideally inalienable right of people.

Antipsychotics, Antiepileptics, and Fabrication: Are We Making It or Faking It?

Antipsychotics, Antiepileptics, and Fabrication: Are We Making It or Faking It?

Factors influencing anti-money laundering regulatory approaches towards casinos and cryptocurrencies in Bangladesh

PurposeThis paper aims to critically explore the factors influencing the regulation of gambling and cryptocurrencies as part of anti-money laundering (AML) initiatives in Bangladesh. As a member of the Asia/Pacific Group on money laundering, Bangladesh must adopt a risk-based approach to regulate these entities.Design/methodology/approachThis study applied an exploratory design and investigated the real nature of the challenge Bangladesh facing in adopting a risk-based approach to regulate gambling and cryptocurrencies.FindingsThis study demonstrates that current regulatory responses towards gambling and cryptocurrencies in Bangladesh are largely influenced by passive wait-and-see policy instead of a proactive risk-based approach, a measure mandated by the Financial Action Task Force (FATF). It demonstrates that these financial entities, which are poorly regulated because of their unclear legal status in Bangladesh and the regulator’s apparent lack of understanding of the type of threats they pose, may facilitate money laundering. Effective risk-based regulation is required to control potential risks.Research limitations/implicationsThis paper focuses on two specific areas –gambling and cryptocurrencies – which are linked to two specific FATF Recommendations: designated non-financial businesses and professions (DNFBPs) and new technologies. Further research is required to investigate the concern from the perspective of other entities.Practical implicationsThe results of this study will help inform policymakers about ways in which current regulatory approaches may need to be modified to better combat money laundering and financing of terrorism.Originality/valueAccording to the authors’ knowledge, this is the first study aiming to explore challenges Bangladesh confronts in implementing a risk-based approach for DNFBPs and new technologies. Therefore, it provides important insights into the dilemma regulators facing in implementing global AML standards within their traditional legislative and regulatory framework.

Platform responsibility for online harms: towards a duty of care for online hazards

ABSTRACT Outpaced by the development of the internet, current regulatory approaches do not protect users from online harms transmitted over online platforms like Facebook, Twitter and Reddit. The Draft Online Safety Bill attempts to improve safety online by developing online analogues for responsibility practices, but is limited by a focus on platforms as service providers hosting content. Online safety requires more than safe services, because platforms are more than content hosts. Platforms, in the social interactions they facilitate, establish online spaces that are governed by platform architecture and algorithms. These spaces present online hazards in the ways they curate content and interactions online, establishing environments that enable online harms. Such consequences are a product of the space that enabled them: of unmanaged online hazards. Incorporating platform responsibility for online spaces and their hazards into the Online Safety Bill’s risk assessment duties enables protection from the full extent of online harms.