Regulatory Option Research Articles

Towards better understanding the economic and environmental sustainability of alternative agricultural cropping production systems through integrated modelling

We explore and develop an integrated model to enhance understanding and evaluation of the economic and environmental sustainability performance of alternative agricultural cropping production systems. More specifically, our developed Environmentally Sustainable Residual Income Decomposition Modelling (ESRIDM) integrates accounting decomposition analysis, Water and Economic Sustainability Performance Measurement (WESM), system thinking, modular thinking, Environmentally Sustainable Residual Income (ESRI) theory, into a holistic modelling system influenced by Life Cycle Assessment (LCA) and Life Cycle Costing (LCC) approaches.The ESRIDM is theorised and applied in the context of nitrogen management in Australian Cotton production through a detailed case study and comparative analysis of three nitrogen fertiliser options. We find the ESRIDM is able to: (i) provide an overall assessment of the economic and environmental sustainability performance of each scenario modelled; (ii) increase the transparency of the production system to enable the identification of key issues which influence the likely suitability of each scenario; (iii) enable an analysis of probable outcomes under various alternatives; (iv) evaluate the feasibility of regulatory option modelled. While this paper offers a novel perspective to a specific context, ESRIDM is designed to be adapted to a variety of contexts with a view to contributing to the evolution of more sustainable systems of production more generally.

К вопросу о сущности юридического приоритета

The author makes one of the first attempts to determine the essence of the phenomenon of “legal priority” not only from the perspective of individual forms of its manifestation, but also through the prism of the philosophy of law, linguistic perception of this phenomenon, as well as the doctrinal positions and normative implementation that exist about it. The modern political and legal concept of objectification of legal priority in public relations is analyzed, on the basis of which it is concluded that it is positioned in two projections: as a preference, i. e. the most desirable regulatory option for the state and society, as well as a legal advantage, i. e. a specific model for improving the legal status of the subject. It is proved that legal priority acts as a means of differentiation and hierarchical construction of various elements of the legal system. The author substantiates the significance of the values that are positioned by the author as a formal legal and moral-ethical criterion for establishing legal priority in legal regulation. The conclusion is made about the need for a full-fledged, general theoretical study of legal priority, the formation of its doctrinal concept.

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate

A Biopharmaceutics Classification System (BCS)-based biowaiver monograph is presented for isavuconazonium sulfate. A BCS-based biowaiver is a regulatory option to substitute appropriate in vitro data for in vivo bioequivalence studies. Isavuconazonium sulfate is the prodrug of isavuconazole, a broad-spectrum azole antifungal indicated for invasive fungal infections. While the prodrug can be classified as a BCS Class III drug with high solubility but low permeability, the parent drug can be classified as a BCS Class II drug with low solubility but high permeability. Interestingly, the in vivo behavior of both is additive and leads isavuconazonium sulfate to act like a BCS class I drug substance after oral administration. In this work, experimental solubility and dissolution data were evaluated and compared with available literature data to investigate whether it is feasible to approve immediate release solid oral dosage forms containing isavuconazonium sulfate according to official guidance from the FDA, EMA and/or ICH. The risks associated with waiving a prodrug according to the BCS-based biowaiver guidelines are reviewed and discussed, noting that current regulations are quite restrictive on this point. Further, results show high solubility but instability of isavuconazonium sulfate in aqueous media. Although experiments on the dissolution of the capsule contents confirmed ‘very rapid’ dissolution of the active pharmaceutical ingredient (API) isavuconazonium sulfate, its release from the commercial marketed capsule formulation Cresemba is limited by the choice of capsule shell material, providing an additional impediment to approval of generic versions via the BCS-Biowaiver approach.

Can Cap-and-Trade Be a Regulatory Option to Address Groundwater Depletion and Irrigation Crises in India? Reflections, Issues & Options.

India is a global hotspot for irrigation-induced groundwater withdrawal, leading to widespread lowering of water levels, in turn resulting in disproportionate access to irrigation supplies among farming communities. Efforts to mitigate the situation, however, have fallen short, largely due to technocentric vision (e.g. microirrigation adoption) of the regulatory authorities (RAs), which does little to integrate the vast groundwater-dependent socioecologies with the decision making system. In view of that, we invite the RAs to deliberate upon a cap-and-trade mechanism that proposes to mobilize the farmers at every aspect of planning and execution, while to tackling multiple challenges simultaneously: (a) restrict groundwater pumping to a pre-defined safe level (cap), (b) creating a shared space/quotas for all to pump (allocation); and (c) making provisions for trade of allocations. The latter further augments farmers' access to groundwater (and irrigation). Using a systematic bibliometric analysis of relevant world literature and contextual appraisal of groundwater-irrigation landscape in India, we develop a conceptual framework of cap-and-trade in three parts. In the first Pre-implementation stage, we emphasize a reality check study to assess ground conditions, if favorable for a cap-and-trade approach (existing social, economic, institutional circumstances). Next, in the Implementation stage, (1) we recommend an integrated hydrogeological-hydrometeorological modeling to determine flexible capping arrangements, with the possibility of delineating certain priority regions (coastal ecosystems); (2) for allocations, a reasonable fraction of the cap over a defined period; we envision a thoroughly participatory arrangement, centering on four action areas: identifying, informing, consulting, and involving the farmers, alongside all stakeholders engaged in the groundwater-irrigation decision making; (3) for trade, we urge the RAs to create win-win situations for both the sellers and buyers; develop the transaction protocols on certain foundational principles (e.g. simplicity, transparency and consistency); strengthening of local institutions, and development of targeted financial support schemes. We consider the third part of the narrative, Post-implementation stage, as a real game changer, comprising of a monitoring, auditing (performance benchmarking) component coupled with multitiered outreach-mentoring drives that demonstrate to the farmers the benefits of becoming part of the cap-and-trade program. Overall, a main motivation to present this research is to shatter the age-old socio-cognitive beliefs/taboos around groundwater pumping (My land, My Water), breaking the hegemony of the water sellers (rich/wealthy large landholder clans), to potentially, create a social norm whereby the farmers realize the value of restricting groundwater pumping and sharing for mutual prosperity.

Distributed Ledger Technology in Financial Markets. The European Union Experiment

The European Union Regulation 2022/858 of 30 May 2022 establishes a pilot regime for market infrastructures based on distributed ledger technology. The Pilot Regulation is part of the 2020 Digital Finance Strategy whose objective is for the European Union to embrace the digital revolution and to benefit consumers and business. This article analyses the reasons of this new regulatory option and why this represents a different paradigm of legislation, considering first some advantages, risks and challenges that applying distributed ledger technology in financial markets can encounter. Moreover, this article examines the content of the EU Pilot Regulation with a critical perspective, comparing the previous proposal of Regulation with the current Pilot Regulation which enters into force mainly in March 2023. Significance of this Pilot Regulation could be enhanced if it coordinates with other policy goals such as sustainability and transparency set by the EU legislator. Lacking that coordination, this Pilot Regulation could be perceived as a miss opportunity to foster a digital and green financial markets transition.
 

Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record.

From 2018 to 2020, U.S. federal mandates began requiring the use of a single institutional review board (sIRB) of record for federally funded, multisite studies. With an interest in the efficiency of site activation, we compared the frequency with which local review and approval and three different reliance options (ways to establish a reliance agreement between the sIRB and the relying institution) were used during this period in a multisite, non-federally funded study (ClinicalTrials.gov identifier: NCT03928548). Using general linear models, we analyzed the relationships between local reliance or approval and sIRB of record approval times and (a) the regulatory option selected and (b) relying-site and process characteristics. Eighty-five sites received sIRB approval through 72 submissions (40% using local review, 46% using the SMART IRB agreement, 10% using an IRB authorization agreement, and 4% using a letter of support). Median time to establish a local reliance or study approval and sIRB approval were longest for sites using a SMART IRB agreement. Study-site region and the time of submission were significantly associated with local reliance or approval time, which averaged 129 and 107 days faster for Midwestern (p = 0.03) or Western (p = 0.02) sites, respectively, and 70 days slower for Northeastern sites (p = 0.42) compared with sites in the South, and 91 days slower when regulatory communication was initiated during or after February 2019 compared with before (p = 0.02). Similar relationships between sIRB approval time and region and time frame were observed; in addition, approval time was 103 days slower for sites affiliated with a research 1 (R1) university versus not (p = 0.02). Region of the country, time frame, and R1 university affiliation were associated with variations in study-site activation in a non-federally funded, multisite study.

Liberty to Request Exemption as Right to Conscientious Objection

There is a regulatory option for conscientious objection in health care that has yet to be systematically examined by ethicists and policymakers: granting a liberty to request exemption from prescribed work tasks without a companion guarantee that the request is accommodated. For the right-holder, the liberty’s value lies in the ability to seek exemption without duty-violation and a tangible prospect of reassignment. Arguing that such a liberty is too unreliable to qualify as a right to conscientious objection leads to the problem of consistently distinguishing its effects from those of a right to conscientious objection that is made conditional on an individual assessment of the objector’s motivation. These properties require that we distinguish the liberty to request exemption from more restrictive policy choices, and that we subject it to greater scrutiny in the wider moral discourse as a possible variant of a right to conscientious objection.

(Re)thinking the International Labour Law: International Labour Standards, Regulatory Strategy and Universality

In 2020, for the first time in the history of the International Labour Organization (ILO), we sighted the universal ratification of a Convention, that is, the ratification by all 187 Member States of the Organization. The C182—Convention of Worst Forms of Child Labour (1999) is identified as a fundamental Convention because it refers to one of the fundamental labour rights identified at ILO Declaration on Fundamental Principles and Rights at Work (1998). This Declaration, despite having been immersed in intense debates on the regulatory option adopted by the ILO (soft law), spelled out a list of fundamental rights and principles at work, approaching to the grammar of human rights. In this sense, it is possible to understand that Convention No. 182, since it is fundamental, already had a prominent role. However, universal ratification presents itself as opportune and strategic, especially when it formalizes the commitment of States to the observance of the parameters presented in the respective international labour standard. Thus, using the deductive method (Lakatos, Marconi 2003) and the bibliographic and the documentary research techniques, the study is going to analyse the importance of universalizing international labour standards for International Labour Law.

TERMINATION OF THE CASE BY THE COURT IN CRIMINAL, ARBITRATION, CIVIL AND ADMINISTRATIVE LITIGATION: TRENDS AND ACCIDENTS

The novelty of the article is determined by a comparative analysis of the institution of the dismissal of a case by a court in various branches of judicial law. The purpose of this analysis is to identify general trends in the regulation of the grounds and procedure for terminating a criminal case by a court and a court case in arbitration, civil and administrative processes. The task was to determine unreasonable differences between similar norms of procedural branches and to select the best regulatory option. The article uses the methods of system analysis and synthesis, the comparative legal method. As a result of the study, the general legal nature of the plaintiff and the public prosecutors refusal from the claims, the death of a participant in the legal proceedings and the existence of a court decision on the same dispute as the grounds for termination of the case by the court, suggesting the same approaches to the regulation of the relevant legal relations in all types of judicial proceedings by the law, is proved. The relationship of a world (reconciliation) agreement and reconciliation with the victim is determined. In conclusion, the ways of improving the criminal procedure institute for terminating a case by a court are named.

Структурні чинники механізму інформаційної безпеки держави

У науковій статті викладається ступінь та еволюція механізму інформаційної безпеки. З'ясовано, що термін «механізм інформаційної безпеки держави» базується на основі детермінантів і принципів безпеки.
 Інформаційна безпека країни може розглядатися з позиції забезпечення захисту життєво важливих інтересів усіх громадян, суспільства й держави від внутрішніх і зовнішніх загроз.
 Автор зазначає, що інформаційна безпека - це динамічний елемент економіки, який адаптується до вимог свого часу. Таким чином, розглядаючи поняття інформаційної безпеки, слід виходити з визначення рівноваги економічної системи та її подальшого сталого розвитку.
 Також розглядається взаємодія засобів масової інформації та державних органів влади. Аналізується впровадження інформаційно-комунікаційних технологій як фактору подальшого розвитку інформаційних процесів та ефективнішого розвитку державних політико-правових інститутів. Розглянуто можливі варіанти підвищення ефективності інформаційного забезпечення державної політики. Показано, що інформаційне забезпечення державної політики з доступом громадян до відкритих державних ресурсів є одним зі складників національних інтересів України в інформаційній сфері.
 Автор доходить висновку, що з метою вдосконалення нормативно-правового забезпечення механізму інформаційної безпеки держави доцільно: на законодавчому рівні виробити єдину термінологію, характерну для цієї сфери, у формі глосарію як обов'язкового нормативного варіанта для інших правових актів, що належать до інформаційної безпеки; внести категорію інформаційної безпеки держави в Єдиний державний реєстр нормативно-правових актів; уточнити положення Доктрини інформаційної безпеки України, визначивши, що об'єктом інформаційної безпеки є забезпечення права на інформацію, права на захист від небезпечної інформації, права на недоторканність приватного життя громадян.

Field Evaluation and Simulation Modeling of Length Limits and their Effects on Fishery Quality for Muskellunge in the New River, Virginia

AbstractThe trophy fisheries for Muskellunge Esox masquinongy in the northern U.S.A. and Canada often are developed and maintained by using high minimum‐length limits (MLLs). However, the effectiveness of using such MLLs on southern‐latitude Muskellunge populations, which have different rates of growth and mortality, warrants further research. The Muskellunge fishery in the New River, Virginia, was managed under a 30‐in (75 cm) MLL until 2006 when the MLL was increased to 42 in (105 cm) to increase the abundance of large Muskellunge. We measured fishery quality before and after the institution of the 42‐in MLL using size structure, average individual condition, rates of growth and mortality, and CPUE. We also assessed the potential of alternative length regulations (other MLLs and a 40–48‐in protected‐slot limit) to improve the population's size structure and trophy production using simulation models in the Fisheries Analyses and Modeling Simulator (FAMS) program. Following the institution of the 42‐in MLL, we observed a 5‐in increase in the average size of Muskellunge, an increase in the population's size structure with greater proportions of memorable‐size individuals (≥42 in) and an increase in the abundance of memorable‐size Muskellunge. However, declines in the average condition, i.e., relative weight (Wr), of large Muskellunge (≥38 in) suggest there is possible stockpiling of individuals just below the 42‐in length limit. Higher MLLs (e.g., 48‐in MLL) could further improve fishery quality by increasing the survival of Muskellunge to large trophy sizes (≥50 in). However, managers should be wary of stockpiling under alternative MLLs as well. Furthermore, a higher MLL is unlikely to garner broad angler support in this system. Conversely, a protected‐slot limit that allows the production of some trophy‐sized Muskellunge while reducing the overall number of individuals, and that limits potential for stockpiling, may be a more agreeable regulatory option for New River fishery managers. These findings and the methods described within this study may be useful for fisheries managers working on other Muskellunge fisheries in southern systems.

A critical appraisal of the harm reduction argument for heat-not-burn tobacco products.

ABSTRACTHeat-not-burn products (HNBs) are efficient nicotine delivery devices that heat tobacco instead of burning it, as conventional cigarettes do. Since heating yields less carbon monoxide and other tobacco pyrolysis–derived toxicants, tobacco companies claim that HNBs are less harmful than conventional cigarettes are. Although this hypothesis is plausible, no long-term clinical trials and/or observational studies are available to corroborate it. To overcome barriers to the entry of tobacco products to the market, manufacturers of HNBs argue that they are a new wave of harm reduction alternatives. Nonetheless, even if HNBs were in fact less harmful than conventional cigarettes, they would still have the potential to cause nicotine addiction (a major health hazard) and other harms to smokers’ health. HNBs deliver nicotine, provide users a tobacco aroma and flavor and some rituals of smoking, and are supposedly safer than conventional cigarettes. Owing to these features, HNBs are likely to enhance smoking appeal and initiation among young persons and discourage smokers’ attempts to quit. In other words, if HNBs were freely available on the market, they would increase the prevalence of smoking. However, HNBs may constitute a harm reduction alternative for nicotine-dependent smokers who are unable or unwilling to quit smoking. Given these facts, approval of HNBs for use under medical supervision (prescription only), along with strict restrictions on advertising, is a balanced regulatory option that would reconcile the therapeutic needs of nicotine-addicted patients with the public heath goal of achieving a smoke-free generation in the near future.

GDPR-Lite and requiring strengthening – Submission on the draft <i>Personal Data Protection Bill</i> to the Ministry of Electronics and Information Technology (India)

This submission concerns the draft Personal Data Protection Bill which accompanies the July 2018 Report of the Committee of Experts on Data Protection (‘Srikrishna Report’) appointed by the Indian government. The submission makes five general comments about the Bill, on these topics: 1. The draft Bill is a serious and modern draft law, and should only be strengthened, not weakened by MeitY in preparing a Bill for submission to the legislature. The Indian government has compelling reasons to enact a Bill resembling this draft. 2. The Report and Bill both reflect a very different regulatory philosophy from the EU GDPR’s radical dispersal of decision-making responsibility (and liability for wrong decisions) to data controllers. The Indian model is more prescriptive, but a justifiable regulatory option, provided it does not include excessive discretion to the government or the Data Protection Authority. 3. The Bill's data localisation requirements adopt an unjustifiable generic approach to data localisation, through blanket local copy requirements (with exceptions to be specified by government), and export prohibitions also specified by government. 4. The very broad exemptions from most of the Act for processing in the interests of State security or relating to law enforcement, although purportedly constrained by legality, necessity and proportionality (are dangerously vague). 5. The lack of complete independence of the DPIA, and the lack of any legislatively guaranteed independence by the Adjudicating Officers, represent unsound policy in relation to bodies whose function is to regulate government as well as the private sector. The submission also includes fifteen more specific recommendations for improvements to the Bill.

Editorial Comment

Post prostatectomy incontinence (PPI) is a troubling and for some men a devastating complication after prostate surgery. Although the artificial urinary sphincter device remains the mainstay of therapy, various other options have been introduced over the past decade including sling devices. The Argus—T sling is a variation of a transobturator theme with a postoperative regulatory option. Overall, the data suggests that there are men who benefit from the procedure. However, as with most reports for incontinence procedures in both men and women, definitions of both short term and long term success are not standardized. The authors have a very broad definition of success including cured (0-1 pads/24 hours) and or improved (1-2/pads/24 hours or a 50% reduction in pad usage). The cure rates are actually quite low (28% in severe and 40% in mild PPI). The authors do not report in their improved cohort as to whether it was 1-2 pads or a 50% reduction. It would have been of interest to see if there was correlation with baseline preoperative leak point pressure and post operative results. Overall, as with other male slings, it appears that the best chance for success is in those with mild PPI. While one could argue that a reduction of 6 to 3 pads is by the authors definition as an improvement, most patients would not consider that to be a success. Given that more than 40% of men need a second procedure under anesthesia for “regulation” and the overall underwhelming improvement, I suspect that the long term commercial viability is at best challenging.

Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion.

Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion.

The 'Likeness' of New and Conventional Tobacco Products in the WTO

The regulation of e-cigarettes is a relatively new topic and the optimal regulation of these products is not yet fully understood. Evaluations are underway on many aspects linked to these products, for example: their safety, potential health risks, illicit trade, and advertising. Given the WHO-promoted regulatory option to ban e-cigarettes, this paper examines another topic, emerging at the intersection of international health and trade law, that is the legal challenges which may arise under the WTO following a complete ban of e-cigarettes (herein forth called new products). In particular, the analysis considers the consistency with WTO law of a hypothetical ban on the importation, distribution, sale and offering for sale of these products – a measure that is either being contemplated or already implemented in some domestic jurisdictions. In this context, the paper assesses the ‘likeness’ of new products and regular cigarettes and examines such a measure under other standards developed within the GATT 1994 and TBT Agreement (e.g. the aim-and-effect test, necessity and legitimate regulatory distinction). It finds that new and conventional tobacco products may be ‘like’ under WTO law and in the event no justification is found by the regulating Member under the GATT Article XX General Exception provisions, an importation ban on new products risks being found WTO inconsistent.

The evolution of high complexity companion testing for targeted and immuno-oncology.

The evolution of high complexity companion testing for targeted and immuno-oncology.

Hiding the tobacco power wall reduces cigarette smoking risk in adolescents: using an experimental convenience store to assess tobacco regulatory options at retail point-of-sale

ObjectivesThis experiment tested whether changing the location or visibility of the tobacco power wall in a life sized replica of a convenience store had any effect on adolescents’ susceptibility to...

Contribuição do método sistema especialista fuzzy na análise de impacto regulatório

No Brasil, a Análise do Impacto Regulatório (AIR) vem se consolidando nas últimas décadas nas agências reguladoras federais. A metodologia AIR tem como objetivo examinar o processo regulatório, medir os custos e os benefícios gerados, assim como outros efeitos de natureza social, política ou econômica que podem ser causados por uma regulação nova ou já existente. Ao analisar cada opção regulatória, o especialista trata variáveis de natureza qualitativa de difícil mensuração e de elevado grau de incerteza. O trabalho complementa a literatura existente, dado que poucos trabalhos no âmbito da AIR têm empregado metodologias de apoio à decisão que incorporem o conhecimento do especialista de forma independente do problema a ser tratado. Portanto, propõe-se uma abordagem exploratória usando um Sistema Especialista Fuzzy (SEF), o qual, incorporando o conhecimento tácito dos especialistas, contribui para enriquecer o processo de decisão na fase final de comparação das opções regulatórias, permitindo o acesso do tomador de decisão a um histórico de parte dos raciocínios de outros especialistas.

Disability, right to culture and copyright: which regulatory option?

Access to knowledge and participation in cultural life for persons with disabilities has always constituted a tough challenge. Recent studies show that only 5% of published works are available in accessible format, and the number plummets to 1% in developing countries. Coupled with the high costs of production and distribution, and the full reliance on public funds and intervention of public or non-profit organizations, copyright has traditionally represented an additional obstacle on the path for a broader availability of accessible works. Recently, the situation has worsened with the tilting in the balance between rights and exceptions caused by the legislative response to digital threats, when the unprecedented opportunities offered by new technologies to foster accessibility have been largely trumped by copyright law. Still, the last decades have witnessed the beginning of a paradigm shift, originating from the human rights arena, and moving towards a new definition of the interplay between authors’ rights and the right to take part in cultural life, both at a general level and with particular regards to persons with disabilities. This article offers a diachronic overview of the path that, from the rediscovery of Article 15 of the International Covenant on Economic, Social and Cultural Rights through its General Comments to Article 30 of the United Nations Convention on the Rights of Persons with Disabilities, has led to the adoption of the Marrakesh Treaty. It then analyses, with a focus on the European Union and its Member States, the national and regional responses to the new human rights obligations, looking at the relations between legislative exceptions and model or collective license agreements. The assessment of the strengths and weaknesses of the two main regulatory options lays the groundwork for proposals of further areas of intervention, necessary to fully comply with the international human rights obligations and to achieve the fullest access to and participation in culture possible for persons with disabilities, by using the tools offered by international and national copyright law.