Regulatory Permission Research Articles

Prevalence of substandard, falsified, unlicensed and unregistered medicine and its associated factors in Africa: a systematic review.

Substandard, falsified, unlicensed, and unregistered medicines pose significant risks to public health in developed and developing countries. This systematic review provides an overview of the prevalence of substandard, falsified, unlicensed, and unregistered medicine and its associated factors in Africa. Articles published from April 2014 to March 2024 were searched in Google Scholar, Science Direct, PubMed, MEDLINE, and Embase. The search strategy focused on open-access articles published in peer-reviewed scientific journals and studies exclusively conducted in African countries. The quality of the studies was assessed according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Of the 27 studies, 26 had good methodological quality after a quality assessment. Of the 7508 medicine samples, 1639 failed at least one quality test and were confirmed to be substandard/falsified medicines. The overall estimated prevalence of substandard/falsified medicines in Africa was 22.6% (1718/7592). The average prevalence of unregistered medicines was 34.6% (108/312). Antibiotics, antimalarial, and antihypertensive medicines accounted for 44.6% (712/1596), 15.6% (530/3530), 16.3% (249/1530), and 16.3% (249/1530), respectively. Approximately 60.7% (91/150) were antihelmintic and antiprotozoal medicines. Poor market regulatory permission, Free trade zones, poor registration, high demand, and poor importation standards contribute to the prevalence of these problems. Substandard, falsified, and unregistered medicines are highly prevalent in Africa, and attention has not been paid to the problem. Antibiotics, antimalarial, anthelmintic, and antiprotozoal are the most commonly reported substandard, falsified, and unregistered medicines. A consistent supply of high-quality products, enhancement of registration, market regulatory permission, and importation standards are essential to counter the problems in Africa. Preventing these problems is the primary duty of every responsible nation to save lives.

Sources of international family law: a posse ad esse non valet consequentia

The sources of international family law are not accurately defined in Russian legislation and legal doctrine, and are often misinterpreted in practice as well. The subject of this study, therefore, is the legal form of private international law norms, to determine the set of sources to be used to resolve cross-border family disputes in Russia. The research methodology adopted by the author includes the logical methods of analysis and synthesis, as well as formal, legal and comparative private scientific methods. A logical result of insufficient attention to the sources of private international law is the persisting ambiguity in their composition, which has manifested into the analysis of the sources of international family law.The author concludes that the broad understanding of private international law sources proposed by legal doctrines and the Supreme Court of the Russian Federation does not find full confirmation in resolving cross-border family disputes in practice. Outdated regulation does not allow international treaties to maintain precedence in the system of sources. Despite the Ruling of the Supreme Court of the Russian Federation on the procedure for its application, the use of international treaties has not become wide-spread in resolving cross-border family disputes by Russian courts.The inconsistency of Russian legislation with the generally recognized principles and norms of international law has sparked academic discussion regarding their regulatory impact. This, however, did not prevent the highest court from referring to them as the sources of private international law for the Russian Federation. This study demonstrates the lack of convincing evidence for their use as a source of international family law.Acts of international organizations, when provided in the form of an international treaty or regulation, can serve as a basis for resolving cross-border family disputes. Acts that do not have a similar expression are not sources, but can influence the legislator due to their rec-ommendatory nature.The domestic legislation of the Russian Federation comprises a large number of Acts con-taining the norms of international family law. While agreeing with the idea of its codification as a whole, the author opines that it requires not only a thorough analysis of de lege lata, but also a balanced approach to de lege ferenda.Customs recognized in the Russian Federation have the potential value of a source of international family law. However, at the same time, their use in resolving cross-border family disputes is not supported by empirical data.Foreign law, including foreign customs, is the set of rules that can be applied in resolving disputes, subject to regulatory permission. They should be distinguished from the sources of law of the national legal system. Therefore, it is incorrect to consider them as sources of private international law of the Russian Federation.

Siting tidal energy projects through resource characterization and environmental considerations

The development of tidal energy technologies has progressed to where devices can be deployed, operated, maintained, and recovered with some level of assurance that they will and produce adequate levels of power. Equally important to further the tidal energy industry is the ability to site and gain regulatory permission to deploy and operate these devices. This paper sets out a framework for reaching preliminary siting of tidal devices, drawing from case studies from three locations in the US where research studies have provided information in support of tidal deployments.
 Through the TEAMER funding opportunity in the US, tidal energy device and project developers were able to engage US Department of Energy national laboratory scientists and engineers to provide technical assistance for investigating potential tidal deployment sites within US waters. The bodies of water of interest had already been determined by the proponents at the start of the project and constraints and opportunities within those bodies of water were examined to optimize siting capabilities for the developers. Using numerical models and field observations, we characterized tidal resources at a scale that will allow for optimization of energy extraction. We examined the natural and human infrastructure constraints for deploying and operating tidal devices and arrays including channel widths, bathymetry, vessel traffic, ferry lanes, and grid interconnects, in order to narrow siting options. We also examined the biological resources in the water bodies of interest, with a focus on populations of endangered marine mammals and fish, and the critical habitats that support them. The biological resources were then related to the applicable regulatory requirements in place in US for federal and state statutes in areas where the tidal applicants wish to deploy. Based on these analyses, preferred deployment locations were delineated and processes for meeting regulatory requirements laid out, including post-installation monitoring plans that will be needed. This initial assessment of logistical, regulatory, and environmental conditions for the deployment of a tidal technology is a first step toward the achievement of regulatory compliance for tidal energy projects.
 Three locations were considered for tidal energy development in the US. The first one included the area around an archipelago of islands in the northern portion of Washington State, near the US-Canada border, with the intent of installing one or more floating tidal devices to add energy resilience and independence for the single utility that services the isolated islands. The second location was in the coastal waters of Maine where tidal power would be added to the local electrical grid. The third location was in Cook Inlet, Alaska, where the applicant seeks to deploy multiple floating tidal devices to provide renewable energy in place of conventionally generated power for the city of Anchorage.

Analytical Method Development by HPLC to Evaluate the Stress Degradation Stability Profile of Ertugliflozin

Diabetes is a chronic disease in which the body does not make or properly utilize the insulin, a hormone that is required to convert blood sugar, starches, and other food into energy by circulate the glucose from blood into the body cells”. People are going on making new drugs and new formulations of the existing drugs within very short period of time. To get the regulatory permission for marketing, company has to submit required data including the analysis reports as to prove that their drug product is of required quality for its intended use. T2DM, the predominant type of diabetes accounting for >90% of all diabetes cases, is a progressive disease involving parallel defects of glucose metabolism in multiple tissues. Common risk factors for T2DM include increasing age, smoking, being overweight or obese, physical inactivity and poor nutrition. Ertugliflozin is an oral, selective inhibitor of sodium glucose co-transporter-2 (SGLT2) which inhibits renal glucose reabsorption and results in urinary glucose excretion (UGE) and reductions in plasma glucose and haemoglobin A1c (A1C) in patients with type 2 diabetes mellitus (T2DM).The present developed analytical method was developed using 0.1% Formic acid in water: 0.1% Formic acid in ACN as the mobile phase. The developed method was found to be sensitive and time and cost effective with the reduced the use of organic chemicals in the mobile phase. Improved stability-indicating RP-HPLC method was developed for the estimation of ertugliflozin. Retention times compared to the best method reported. The developed method could be suitable for routine analysis of the drugs in bulk and tablet formulation after complete validation as per ICH guideline.

The use of numerical simulation to determine the coal combustion efficiency in the A-USC boiler

In this paper, numerical simulation of coal combustion in the invert furnace of a boiler for a 500 MW power unit designed to operate on advanced ultra-supercritical steam parameters (A-USC) is performed. The use of A-USC technology makes it possible to reduce fuel costs for electricity production compared to steam turbine units of previous generations. Also it influences to reduce the level of emissions of harmful substances into the atmosphere. Modeling of the invert furnace at the nominal boiler load was carried out for the developed direct-flow burners and nozzles arrangement of burning coal. After numerical simulation the results were obtained and made it possible to analyze the furnace aerodynamics and the temperature distribution inside the furnace volume. The calculation of the indicators of efficiency and environmental friendliness was carried out and their values appeared smaller than regulatory permissions, which allows us to recommend the developed burners arrangement scheme for its use in invert furnaces. The furnace operation simulation at reduced loads of 70% and 50% was carried out and the results showed the reliability of the developed combustion scheme.

Dose estimates of occupational radiation exposure during radioguided surgery of Tc-99m-PSMA-labeled lymph nodes inrecurrent prostate cancer.

[99mTc]Tc-PSMA-based radioguided surgery (TPRS) represents a curative approach for localized relapse of prostate cancer. For its simplified regulatory permission, the radiation protection authorities require a 99mTc- activity below the exemption limit of 10 MBq at the time of surgery. Our aim was to determine the optimal amount of radioactivity (OAR) to comply with that limit and to estimate the maximum number of TPRS procedures per year and surgeon without triggering the full monitoring obligations. In this retrospective study, a dose rate meter was calibrated using measurements on phantoms and from recently injected (1 min p. i.) patients to determine the activity in the patient from measured dose rates. The effective half-life of 99mTc-PSMA-I&S in patients was determined from repeated dose rate measurements to estimate dose parameters of relevance for radiation protection. External exposures of the surgeons were measured with personal dosimeters calibrated in Hp(10). The surgeon's finger dose Hp(0.07) is estimated from radioactivity measured in resected lymph nodes. Potenzial incorporations were estimated for an activity of 10 MBq. From the first 6 subsequent patients, an effective half-life of 4.15 h was observed. Assuming an operation time 24 h p. i., the OAR was 550 MBq. Operations lasting in average 2 h in a distance of 0.25 m to the patient imply a body dose for surgeons of 4.16 µSv per procedure. Based on these estimates, the surgeon's Hp(10) is less than 1 mSv per year with up to 241 operations per year. Hp(0.07) and potential incorporation of activity do not lead to further limitations. All radiation protection regulations are met with adherence to OAR recommended here without triggering the full monitoring obligations from radiation protection regulations.

BINGE EATING DISORDERS; UPDATED AND EMERGING APPROACHES

Objective: Binge eating disorders (BED) recently become a global health care issue for clinicians with detrimental effects on all organ systems. A multidisciplinary strategy including pharmacotherapy is required for its management.
 Methods: This review is intended to comparatively evaluate the relative efficacy of different pharmacological agents in BED treatment with new therapeutic approaches, focusing on the clinical evidence and on Phase III randomized controlled trials.
 Results: Data suggest that certain treatments have advantages over placebos to reduce binge eating features; however, the small duration of such research with the lack of adequately sized trials was the major limitation in interpreting these findings. Furthermore, these medications are mostly not greatly efficient for BED associated with obesity except for topiramate, which markedly improves the features of binge episodes with weight loss. Till now, lisdexamfetamine is still the only drug with regulatory permission for BED therapy; however, its weight loss efficacy has not been established.
 Conclusion: Drugs alone or in combination approaches may be useful pharmacotherapies to yield promising outcomes acutely and over longer-term follow-up in the treatment of BED.

The Coronavirus Pandemic: A Pitfall or a Fast Track for Validating Cell Therapy Products?

The global COVID-19 pandemic has prompted urgent need for potential therapies for severe respiratory consequences resulting from coronavirus infection. New therapeutic agents that will attenuate ongoing inflammation and at the same time promote regeneration of injured lung epithelial cells are urgently needed. Cell-based therapies, primarily involving mesenchymal stromal cells (MSCs) and their derivatives, are currently investigated worldwide for SARS-CoV-2-induced lung diseases. A significant number of academic centers and companies globally have already initiated such trials. However, at a time of unprecedented need, it is also foreseen that families and caregivers will seek all available options, including access to cell-based and other investigational products, even before proven safety and efficacy as well as regulatory approval. This should not be an excuse for opportunists to sell or advertise unproven therapies of any kind. "Compassionate use" should be conducted in the context of a clinical investigation framed by strict ethical and regulatory permissions, with the goal of obtaining mechanistic information wherever possible.

Approval of Itolizumab for COVID-19: A Premature Decision or Need of The Hour?

Itolizumab is a first-in-class anti-CD6 monoclonal antibody that was initially developed for various cancers and was later developed and approved in India for treatment of moderate to severe chronic plaque psoriasis in 2013. This drug is now being re-purposed for COVID-19. The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use. Subsequently, a phase II, open-label, randomized, placebo-controlled trial has been conducted in 30 COVID-19 patients in India after receiving regulatory permission. Based on the results, the Indian drug regulatory agency recently approved itolizumab in July 2020 for ‘restricted emergency use’ for the treatment of CRS in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. This has drawn sharp criticism within the scientific community, with the approval being granted on the basis of a relatively small phase II trial, without conduct of a conventional phase III trial, and lacking availability of the claimed supportive real-world evidence in the public domain to date. In a global scenario where finding a successful treatment for COVID-19 is of utmost priority, a biologic agent has been re-purposed and approved with a successfully completed RCT, in a country where cases and mortality due to COVID-19 are growing exponentially. However, instead of welcoming the approval with open arms, many doubts are being raised. This is an issue that needs to be considered and dealt with sensitively, as well as scientifically.

Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC) - a randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants

IntroductionChronic lung disease of prematurity (CLD), also known as bronchopulmonary dysplasia (BPD), is a cause of significant respiratory morbidity in childhood and beyond. Coupled with lung immaturity, infections (especially by...

Supporting visitor compliance with a smoke-free policy at hospital using a nicotine replacement therapy vending machine.

Issue addressedTo support visitors to comply with Central Coast Local Health District's (CCLHD) smoke‐free hospital grounds policy, a need was identified for round‐the‐clock availability of nicotine replacement therapy (NRT). Providing NRT through a vending machine was identified as a possible solution. This initiative complemented other strategies that provide staff and patients who smoke with NRT.MethodsNRT was originally provided through a snack vending machine; however, there were commercial and regulatory concerns with this method.In 2015, dedicated NRT vending machines were installed at Gosford and Wyong Hospitals, and were operated by the Health Promotion Service. The appropriate regulatory permission was gained to supply a specific brand of NRT. Sales and incident data were recorded, and ongoing smoking counts were performed both before and after installation.ResultsIn all, 247 sales of NRT gum were made through the vending machines from early 2017 to late 2019. Smoking counts show that there are very low rates of visitor smoking (<1%) in the approximately 4.5 years pre‐ and post‐installation of dedicated vending machines. There was no statistically significant change in the smoking rate of visitors since the vending machine was installed at Wyong Hospital.ConclusionsWhile NRT is generally provided to patients and staff within health settings to support compliance with smoke‐free policies, alternatives to smoking for visitors are typically overlooked. A NRT vending machine achieves this. However, because there are few purchases made, the vending machines as currently operating are unlikely to make any significant impact on smoke‐free policy compliance at these hospitals.So what?While vending machines have limited effectiveness on overall smoke‐free policy compliance, this strategy may have applicability to all sectors with smoke‐free policies, especially those operating 24 hours a day, as a means of providing an alternative to smoking for visitors.

Comparison of three Agrobacterium-mediated co-transformation methods for generating marker-free transgenic Brassica napus plants

BackgroundGeneration of marker-free transgenic plants is very important to the regulatory permission and commercial release of transgenic crops. Co-transformation methods that enable the removal of selectable marker genes have been extensively used because they are simple and clean. Few comparisons are currently available between different strain/plasmid co-transformation systems, and also data are related to variation in co-transformation frequencies caused by other details of the vector design.ResultsIn this study, we constructed three vector systems for the co-transformation of allotetraploid Brassica napus (B. napus) mediated by Agrobacterium tumefaciens and compared these co-transformation methods. We tested a mixed-strain system, in which a single T-DNA is harbored in two plasmids, as well as two “double T-DNA” vector systems, in which two independent T-DNAs are harbored in one plasmid in a tandem orientation or in an inverted orientation. As confirmed by the use of PCR analysis, test strips, and Southern blot, the average co-transformation frequencies from these systems ranged from 24 to 81% in T0 plants, with the highest frequency of 81% for 1:1 treatment of the mixed-strain system. These vector systems are valuable for generating marker-free transgenic B. napus plants, and marker-free plants were successfully obtained in the T1 generation from 50 to 77% of T0 transgenic lines using these systems, with the highest frequency of 77% for “double T-DNA” vector systems of pBID RT Enhanced. We further found that marker-free B. napus plants were more frequently encountered in the progeny of transgenic lines which has only one or two marker gene copies in the T0 generation. Two types of herbicide resistant transgenic B. napus plants, Bar+ with phosphinothricin resistance and Bar+EPSPS+GOX+ with phosphinothricin and glyphosate resistance, were obtained.ConclusionWe were successful in removing selectable marker genes in transgenic B. napus plants using all three co-transformation systems developed in this study. It was proved that if a appropriate mole ratio was designed for the specific length ratio of the twin T-DNAs for the mixed-strain method, high unlinked co-insertion frequency and overall success frequency could be achieved. Our study provides useful information for the construction of efficient co-transformation system for marker-free transgenic crop production and developed transgenic B. napus with various types of herbicide resistance.

Proposed Modifications in the 6-Minute Walk Test for Potential Application in Patients With Mild COVID-19: A Step to Optimize Triage Guidelines.

Proposed Modifications in the 6-Minute Walk Test for Potential Application in Patients With Mild COVID-19: A Step to Optimize Triage Guidelines.

A análise econômico-jurídica da arbitragem expedita

Expedited arbitration is an appropriate and private method of conflict resolution, with international origin. This method is progressively adopted in Brazil by virtue of legislative and regulatory permission, to resolve disputes of low complexity and low values involved. This study aims to analyze expedited arbitration from the perspective of the Law &amp;amp; Economics, as a tool to verify transaction and opportunity costs in choosing the procedure to adopt. In the research was adopted the method of theoretical and deductive approach, using the method of documentary research procedure. For this purpose, bibliographic research, data collection and legislative and regulatory analysis were used. The research contributes to the identification of the procedure as a way of giving companies access to arbitration through an important cost-benefit relationship, depending on the quantity and quality of the information that the parties are willing to present to each other and to the arbitrator in a short time. As a result, it can be concluded that the economic-legal analysis of expedited arbitration can demonstrate that the expedited procedure presents itself as a transaction and opportunity cost reducer, bringing advantages to parties who need a speedy specialized judgment in cases of low complexity. Expedited arbitration; transaction costs; opportunity costs.

Ripe for Reform: Modernizing the Regulation of Financial Advice

Over the last 25 years the investment advisory industry has evolved and expanded its services to meet the needs of a more demanding and active investing public. Canadians have increasingly shifted their preferences away from putting their money into deposit accounts and moved it into market securities, which has led to a significant increase in the demand for the services of investment advisers. To meet the growing demand for advice and serve a broader range of customers efficiently, many traditional investment dealers have consolidated, merged with larger financial institutions, or restructured into single, multidisciplinary firms. Adding to the pace of change, advisory firms have responded to increased consumer demand by creating new service models, including digital forms, to provide their clients with new offerings and more convenient access. Many dealer firms support advisers that are registered with a range of regulators including the Mutual Fund Dealers Association (MFDA), the Investment Industry Regulatory Organization of Canada (IIROC) or the l’Autorite des marches financiers (AMF) in Quebec, where the MFDA is not recognized. As they combine the management and operations components of previously separate regulated firms, dealers must respond to, and manage multiple regulators, meaning overlapping and sometimes competing requirements. And as their advisers increasingly seek greater flexibility outside the narrow rules they must operate under, a blurring of lines is developing across regulatory bodies. As a result, the industry and its Self Regulatory Organizations (SROs) are somewhat out of sync and no longer a good fit for each other. A merging of SROs would create a more finely tailored, fit-for-purpose oversight regime. Such a merger is relatively simple to accomplish. The Boards of the MFDA and IIROC could decide to merge without having to seek regulatory permission to do so. Such an initiative would remove operational complexity and costs for dealers; streamline and bring greater efficiency to the regulatory oversight process; and give advisers the flexibility to grow and expand to respond to their clients’ financial service needs as they move through their life-stages. This would help dealers and advisers deliver a more affordable, responsive and coordinated service to their investor clients and reduce the overall regulatory burden on the industry. In fact, a longer-term assessment of regulatory effectiveness could measure how accessible and affordable regulated advisory services are for the individual consumer and how successful those services are in getting consumers to develop good financial habits and build wealth. This paper does not provide an exhaustive assessment of all the changes that would lead to a thoroughly modernized framework. A full effort can only be mounted with resources from all of the regulatory bodies concerned and all of its industry players, which must manage the multiple regulatory relationships. It also requires the full political support of the government ministers to whom these bodies report and who have a strong interest in improving the efficiency and productivity of the agencies they regulate.

A Telephone for the World: Iridium, Motorola, and the Making of a Global Age by Martin Collins

Reviewed by: A Telephone for the World: Iridium, Motorola, and the Making of a Global Age by Martin Collins Rebecca Slayton (bio) A Telephone for the World: Iridium, Motorola, and the Making of a Global Age. By Martin Collins. Baltimore: Johns Hopkins University Press, 2018. Pp. 280. Hardcover $44.95. Iridium was an ambitious business and engineering venture that aimed to provide telecommunications services to the entire world. Using both published sources and oral history interviews, Martin Collins's new book situates Iridium in the transition from the Cold War era, in which U.S. military interests played a dominant role in shaping technological research and development, to an era in which neoliberal philosophy and free markets seemed ascendant. Collins argues that Iridium represented corporate, technological, and ideological conceptions of "the global." Launched by the U.S.-based multinational corporation Motorola, Iridium was part of a broader globalization of Western businesses that characterized the late twentieth century. Technologically, Iridium was literally global; initial proposals envisioned seventy-seven satellites (hence "Iridium," the element with atomic number seventy-seven), providing communications to any place on earth. And ideologically, the project drew upon and amplified the notion that global markets were a force for social progress. Iridium grew out of the Systems Engineering Group within Motorola's Government Electronics Division, which aimed to move beyond the division's traditional work as a subcontractor for military, intelligence, and space projects by becoming a prime contractor for commercial as well as government customers. Iridium eschewed new technology and instead focused on the organizational innovations needed to achieve "manufacturability" in a globally-dispersed workforce. This meant focusing on "quality," as epitomized for example in Motorola's Six Sigma method of reducing errors to 3.4 per million opportunities (the fraction of instances more than six standard deviations from the mean of a normal distribution). Whereas previous satellite manufacture had focused on designing single vehicles for worst-case-scenarios, Iridium focused on the timely production of an entire constellation of satellites, which only needed to succeed in aggregate. Iridium also used "culture" as a tool which "aimed to respect the local (whether inhering in an individual, an institution, or a geographic region)" while assuming that "it could be harmonized with the global (as conceived by the venture)" (p. 4). In fact, Iridium hired cultural anthropologists and futurists who predicted that the "Iridium Revolution" would have a beneficial impact on cultures around the world, advancing individual entrepreneurship, women's rights, sexual freedom, and more. In the mid-1990s, major media outlets such as Wired magazine publicized Iridium in similarly glowing terms. [End Page 928] Yet in 1999, Iridium filed for bankruptcy. Despite some rhetoric about uplifting citizens of the developing world, the service was largely marketed to well-heeled business travelers who did not need "global" telecommunications, but rather mobile telecommunications in the major cities that served as hubs of global commerce. By the 1990s, networks based on terrestrial cellular towers could serve these needs with more compact phones, better reliability, and lower costs than a satellite-based network. Additionally, Iridium depended upon partnerships with "gateways" in nations around the world; these were tasked with obtaining regulatory permission to operate Iridium, and then selling the service to companies that would then enroll individual subscribers. But many gateways did not share Western business values or priorities, and faced constraints not anticipated by Iridium; ultimately, they did not generate a sufficient number of customers. The tensions between Iridium's global multinational ambitions and local political and cultural realities played a significant role in the project's demise. Iridium's greatest asset, a globe-spanning satellite constellation, was nonetheless rescued from a fiery fate of de-orbiting and incinerating as the satellites plunged towards the earth. The U.S. military stepped in to encourage a group of investors to buy the satellites, forming Iridium Satellite Corporation. The Defense Information Systems Agency then promptly awarded the new corporation a contract. Iridium was ultimately used for communications in the Iraq and Afghanistan wars. Collins' account of Iridium is well-researched and written. It brings together and builds upon multiple themes in the history of technology, including digital utopianism, "systems" thinking, business history, and...

Tawarruq through PMEX using High Speed Diesel (HSD

On demand of some Islamic banks in Pakistan, the Pakistan Mercantile Exchange (PMEX) designed a structured product over the last some years to enable Islamic banks to do tawarruq using HSD as the underlying commodity. Keeping in view many Shar¯ı‘ah issues, the State Bank of Pakistan (SBP) allowed Islamic Banking Institutions (IBIs) on November 02, 2017 to undertake Commodity Mur¯abah. ah (CM) transactions through the PMEX for a pilot phase till March 31, 2018, the period that has been extended till October 31, 2018. A good move to be seen in this regard was that in the pilot phase HSD based tawarruq could be done only with the Islamic Banking Institutions (IBIs) in Pakistan. However, as IBIs have other modes like mur¯abah. ah and wak¯alah al-istithm¯ar (investment agency) for intra-Islamic banks liquidity placement, use of PMEX platform for tawarruq remained minimal and only six transactions were undertaken by a few IBIs. Keeping in view that the ‘Pilot Phase’ is coming to an end and that some banks have been anxious to get regulatory permission for excessive use of tawarruq as a means of investment and financing, the Journal of Islamic Business and Management (JIBM) considered it appropriate to discuss the related Shar¯ı‘ah issues precisely enabling the Shar¯ı‘ah scholars, the regulator and the practitioners to decide the matter for long-term benefit of Islamic finance industry.

Treatment of oil sands process-affected waters using a pilot-scale hybrid constructed wetland

Constructed wetland treatment systems (CWTSs) could provide a passive, low-energy strategy for mitigating risks associated with oil sands process-affected waters (OSPWs). Due to the large volumes (over 975 million m3), heterogeneous composition, and acute and chronic toxicity of OSPW, passive and efficient treatment to decrease risks to biota will be necessary once operators obtain regulatory permission to discharge into aquatic receiving systems. The research objective was to design, assemble, and measure performance of a pilot-scale hybrid CWTS for treatment of OSPW. Constituents of concern (COCs) identified in OSPW included NAs, oil and grease, As, B, Cu, Pb, and Zn. Oxidizing conditions (net sediment redox > −50 mV) were promoted to allow aerobic degradation of organic constituents, and co-precipitation of arsenic with iron oxyhydroxides. Treatment of Cu, Pb, and Zn was targeted through precipitation with sulfides in reducing “micro-environments” in wetland sediments. Solar photocatalytic reactors (hybrid components) were used to remove recalcitrant organics. Performance was assessed using rates and extents of removal of COCs and changes in toxicity as indicated by Ceriodaphnia dubia. Mean total naphthenic acid fraction compound concentrations decreased from approximately 43 mg/L in untreated OSPW to 10 mg/L following a 16-d retention time in the hybrid CWTS. Mean As and Zn concentrations decreased from 0.026 mg/L and 0.129 mg/L in untreated OSPW to 0.011–0.014 mg/L and 0.052–0.062 mg/L in wetland outflows, respectively. Cu and Pb mass decreased by 13–26% in the CWTS; however, evaporative concentration masked removal (in terms of total metal concentrations). Toxicity (in terms of C. dubia survival and reproduction) of OSPW was eliminated following treatment. Results demonstrate that hybrid CWTSs can effectively degrade NAs and alleviate toxicity associated with metals and organics in OSPW.

Economies of scale and scope in expansion of the U.S. natural gas pipeline network

I analyze cost, capacity, mileage, and technical data for 254 U.S. natural gas pipeline projects over the period 1997–2012. Although project costs exhibit economies of scale over the capacity margin and economies of scope over the spatial margin, network expansion costs may not exhibit cost economies overall. That is, proportional increases in both transmission capacity and length (in miles) may result in a proportional (or even greater-than-proportional) increase in expansion costs. Moreover, large projects (high-capacity pipelines spanning long distances) likely require installation of compression horsepower, which has direct cost effects. My results suggest such projects exhibit significant diseconomies in cost structure. As a result, pipeline tariffs based on cost-of-service pricing likely present a disincentive for prospective pipeline customers to commit to long-term contracts—which are necessary for the pipeline to acquire regulatory permission to build—particularly for large, long-distance expansion projects. The implication is that cost-of-service pricing may inhibit network expansion, exacerbating congestion issues.

Insider Trading and Market Structure

This Article argues that the emergence of algorithmic trading raises a new challenge for the law and policy of insider trading. It shows that securities markets comprise a cohort of algorithmic “structural insiders” that – by virtue of speed and physical proximity to exchanges – systematically gain first access to information and play an outsize role in price formation. This Article makes three contributions. First, it introduces and develops the concept of structural insider trading. Securities markets increasingly rely on automated traders utilizing algorithms – or pre-programmed electronic instructions – for trading. Policy allows traders to enjoy important structural advantages: (i) to physically locate on or next to an exchange, shortening the time it takes for information to travel to and from the marketplace; and (ii) to receive feeds of richly detailed data directly to these co-located trading operations. With algorithms sophisticated enough to respond instantly and independently to new information, co-located automated traders can receive and trade on not-fully-public information ahead of other investors. Secondly, this Article shows that structural insider trading exhibits harms that are substantially similar to those regulated under conventional theories of corporate insider trading. Structural insiders place other investors at a persistent informational disadvantage. Through their first sight of market-moving data, structural insiders can capture the best trades and erode the profits of informed traders, reducing their incentives to participate in the marketplace. Despite the similarity in harms, however, this Article shows that doctrine does not apply to restrict structural insider trading. Rather, structural insiders thrive in full view and with regulatory permission. Thirdly, the Article explores the implications of structural insider trading for the theory and doctrine of insider trading. It shows them to be increasingly incoherent in their application. In protecting investors against one set of insiders but not another, law and policy appear under profound strain in the face of innovative markets.