Current Regulatory System Research Articles

Ukraine pharmaceutical sector: current state of legal regulation

The purpose of the work . Analysis of the legislative support of the Ukraine pharmaceutical sector, the study of problematic issues of the legal protection of sectoral legal relations in order to formulate proposals for improving the legal protection of the rights of subjects of the Federal Security Service of Ukraine. Materials and methods. The study is based on the current regulatory framework of the pharmaceutical sector in the healthcare sector, as well as international regulatory acts regulating the circulation of medicines in EU countries. During the work, the methods of analysis of ATS synthesis, systematization and generalization were used. Results. The national sectoral regulatory framework of pharmacy is mostly aimed at securing the rights of citizens and streamlining public relations arising from the circulation of medicines, but at the same time requires constant improvement, which is caused by the dynamics of the development of public relations in the field of medicines circulation. The state strategy of implementation of the state policy of providing the population with medicines for the period up to 2025, directly notes that the current system of state regulation in the sphere of drug treatment does not fully meet the modern requirements, because the implementation of the legislation of Ukraine is not performed in all directions, and monitoring has no systemic. Conclusions. Legal regulation of Ukraine pharmaceutical sector is a state exercised by the law and the totality of legal means of ordering public relations that arise during the treatment of medicinal products and joint groups of relations with the purpose of their legal consolidation, protection, and development.

Regulating Investment Robo-Advisors in China: Problems and Prospects

The robo-advisor excels at simplifying the process of making investments, improving its efficiency. Since its first appearance in the market, it has been welcomed by investors across the world. However, the current regulatory system in China is not only overly restrictive, but also unable to provide proper guidance to regulate securities investment advisors. The development of Chinese robo-advisor business faces various obstacles, such as high entry barriers, the inability to provide comprehensive wealth management services. These difficulties are due to prohibitions on granting securities advisors full power of attorney. The uncertain legal status of robo-advisors also creates issues with legitimacy. In addition, there is severe information asymmetry and a lack of investor protection in the operation of robo-advisors. These problems have impeded the development of the robo-advisor industry in China. In light of the approaches of the US and Australia in regulating robo-advisors, this paper suggests that China should consider an incremental approach that is tailored to domestic conditions to promote the growth of its robo-advisor industry. Recommended measures include: improving information disclosure requirements, refining the fiduciary duties of robo-advisors, and regulating the algorithms of robo-advisors. Regulatory sandbox may also be considered, as it could encourage the development of financial technology while mitigating the risks arising from the use of such technology.

A Brief Highlight of the Regulatory Framework for Engaging in Business in the Energy Sector in Nigeria

The Energy sector is a very complex and multi-faceted sector in Nigeria’s economy. Ever since the discovery of oil in commercial quantity in Nigeria, oil has accounted for a large chunk of Nigeria’s revenue, thus, implying that the country is a very fertile ground for big companies hoping to invest and expand their petroleum business. However, the country’s energy sector, in a whole, comprising oil and gas and electricity is quite developed, even if not at the desired level. This paper therefore seeks to provide a quick highlight of the regulatory framework for engaging in business in the energy sector in Nigeria. The paper seeks to provide a quick glance at what the law says in order to help an investor determine whether it is worthwhile coming to invest in Nigeria’s energy industry as well as provide a ground for further academic research on the deficiencies of the current regulatory system.

ETERMINATION OF CALCULATED COSTS IN INTERNAL CENTRALIZED SYSTEMS OF DRINKING WATER SUPPLY OF MULTI-APARTMENT HOUSES

The article analyzes the relationship of the system of technical regulation in construction and regulatory relations for the provision of public services. Changes in the current system of legal regulation in the sphere of water supply of apartment buildings are considered. The article shows that the subject of rationing belongs to several areas of regulation, which requires improvement of the methodological basis for the design of in-house systems of hot and cold water supply of an apartment building and the creation of legitimate methodological tools. Recommendations on the formation of methodological procedures, the implementation of which will provide the legal legitimacy of the methods of hydraulic calculation. The method of determining the calculated (limit) costs of cold and hot water in centralized systems of drinking water supply of an apartment building.

Prerequisites for integrated reporting development

The article provides an analytical review of the accounting literature and other scientific sources, which allowed highlighting the main stages of the development of financial statements, determining the historical and practical prerequisites for the formation of integrated reporting and outlining the basic requirements for information reporting capabilities.The purpose of the study is the conceptual understanding of the integrated reporting evolvement. General scientific and special economic research methods, such as dialectical and abstract and logical ones are used to systematize available theoretical material to reveal the element of accounting method. Methods of theoretical generalization, analysis and synthesis have been applied to comprehensive evaluation of the stages of financial reporting development.According to the results of the study, significant influence on the development of the integrated model of accounting has led to the development of economic relations, legal foundations of the functioning of the economy, information needs, the evolution of economic theories: new institutional, evolutionary, theory of rational expectations, theory of exhaustive resources, theory of human capital and the application of these theories to management systems. The main problems of the existing financial statements in accordance with the informational expectations of the stakeholders are identified and substantiated.Formation of new approaches to the development of accounting integrated reporting in Ukraine on the basis of consideration the national peculiarities of accounting system of the current regulatory system requires further study. The study of the formation of integrated reporting in the world economy, international initiatives in the field of integrated reporting, in order to implement the best world practices in Ukraine are pivotal.

Державне регулювання інноваційної діяльності підприємництва як напрям забезпечення сталого розвитку економіки країни

In the period of radical reforms and socio-economic transformations in Ukraine, the formation of foreign policy aimed at close cooperation with other European countries, domestic scientists and practitioners should focus on the main priorities of national policy formation, one of which is the government regulation of innovative processes in domestic entrepreneurship. The state regulation of innovation activity is a rather difficult and lengthy process, requiring the use of an arsenal of actions to strengthen the capacity and form the global positive image of domestic entrepreneurship. The most important task is the formation of such areas of state regulation that would be timely and adaptive to the external conditions in which Ukrainian innovative enterprises operate. The article systematizes the environmental factors that promote and prevent innovation activities. In addition, the authors indicate that the current system of state regulation of innovative activity of business entities in Ukraine does not meet the requirements of the modern development of public relations, and for this reason, the system cannot be considered effective. In this regard, the authors propose measures to improve this system, which include such areas as: changing the structure of commodity production in favor of the processing industries, creating conditions for increasing the income of the working population and, accordingly, increasing purchasing power, and creating a full-fledged investment infrastructure. The model of management of innovative activities of entrepreneurship is developed on the basis of the proposed recommendations. The article determines the direct dependence of state regulation of innovative activities of entrepreneurship on the level of regulation by the development of the country’s intellectual potential and proposes a mathematical model for evaluating the effectiveness of regulation by the latter. The authors make a conclusion about the importance of public administration in the innovation sphere in order to ensure the sufficient level of competitiveness of the country’s economy at the global level, and also highlight the main areas of regulation that require attention from government.

Food safety governance in China: From supervision to coregulation.

The food control and regulatory system in China is beset by several challenges. While firms have to reduce their costs in pursuit of benefits, customers are increasingly focusing on safety and quality of food products. Although the Chinese government has developed more stringent regulatory measures, food safety incidents still occur, including abuse of food additives, adulterated products as well as contamination by pathogenic microorganisms, pesticides, veterinary drug residues, and heavy metals, and use of substandard materials. A national food safety strategy has been proposed to assure food safety from “farm to table.” This paper begins with the analysis of current food regulatory systems and then discusses cogovernance of food safety management in China. We explore the practice in the city of Shenzhen where government intervention has strengthened food control, thereby creating an opportunity to form a coregulatory system. The review highlights that the current food safety regulatory system of multi‐agency structure can inevitably lead to insufficient incentives for business entities. Due to asymmetric information, lack of regulatory resources, and consumer advocacy, coregulation has been developed and is increasingly being promoted as an important instrument of food regulation.

X-ray intensity, stability, and source size characterizations for the 10 kV/5 mA water cooled upgraded Manson source at the Atomic Energy Commission for Laser MégaJoule Facility.

Calibration of x-ray cameras integrated within plasma diagnostics for Laser MégaJoule's experiment is of great interest for interpretations of physical phenomena. At the Atomic Energy and Alternative Energy Commission, an x-ray calibration laboratory has been trying for many years to provide the most relevant calibrations. In the soft x-ray range (<1.5 keV), a model 5 Manson source is used in combination with a concave grating monochromator equipped permanently with an absolute calibrated silicon drift detector. To reduce the calibration time achieved with this experimental setup, the Manson source has been modified to reach an emission current of up to 5 mA (100 µA for a standard source model) while keeping the x-ray monochromatic intensity constant within ∼2% for several operating hours. A water cooling system has been integrated within the anode carousel and an emission current regulation system inside a completely redesigned power supply. In this work, we present characterization of the source size and x-ray intensity as a function of both source voltage and emission current, as well as the stability of this new source. Both arms of the source have been used: one for monitoring the monochromatic spectra and x-ray intensity and the other to measure the source size. An x-ray spot was observed to be evolved from the oval shape toward the annular one as the emission current increases. For fixed emission current, the source size is reduced as the voltage increases. The x-ray intensity has significantly been increased to a maximum factor of ∼20 (depending on the anode) while being constant within around 2% as expected.

Shifting practise: recognizing Indigenous rights holders in research ethics review

Purpose For many Indigenous nations globally, ethics is a conversation. The purpose of this paper is to share and mobilize knowledge to build relationships and capacities regarding the ethics review and approval of research with Indigenous peoples throughout Atlantic Canada. The authors share key principles that emerged for shifting practices that recognize Indigenous rights holders through ethical research review practice. Design/methodology/approach The NunatuKavut Inuit hosted and led a two-day gathering on March 2019 in Happy Valley-Goose Bay, Newfoundland and Labrador, to promote a regional dialogue on Indigenous Research Governance. It brought together Indigenous Nations within the Atlantic Region and invited guests from institutional ethics review boards and researchers in the region to address the principles-to-policy-to-practice gap as it relates to the research ethics review process. Called “Naalak”, an Inuktitut word that means “to listen and to pay close attention”, the gathering created a dynamic moment of respect and understanding of how to work better together and support one another in research with Indigenous peoples on Indigenous lands. Findings Through this process of dialogue and reflection, emergent principles and practices for “good” research ethics were collectively identified. Open dialogue between institutional ethics boards and Indigenous research review committees acknowledged past and current research practices from Indigenous peoples’ perspectives; supported and encouraged community-led research; articulated and exemplified Indigenous ownership and control of data; promoted and practiced ethical and responsible research with Indigenous peoples; and supported and emphasized rights based approaches within the current research regulatory system. Key principles emerged for shifting paradigms to honour Indigenous rights holders through ethical research practice, including: recognizing Indigenous peoples as rights holders with sovereignty over research; accepting collective responsibility for research in a “good” way; enlarging the sphere of ethical consideration to include the land; acknowledging that “The stories are ours” through Indigenous-led (or co-led) research; articulating relationships between Indigenous and Research Ethics Board (REB) approvals; addressing justice and proportionate review of Indigenous research; and, means of identifying the Indigenous governing authority for approving research. Research limitations/implications Future steps (including further research) include pursuing collective responsibilities towards empowering Indigenous communities to build their own consensus around research with/in their people and their lands. This entails pursuing further understanding of how to move forward in recognition and respect for Indigenous peoples as rights holders, and disrupting mainstream dialogue around Indigenous peoples as “stakeholders” in research. Practical implications The first step in moving forward in a way that embraces Indigenous principles is to deeply embed the respect of Indigenous peoples as rights holders across and within REBs. This shift in perspective changes our collective responsibilities in equitable ways, reflecting and respecting differing impetus and resources between the two parties: “equity” does imply “equality”. Several examples of practical changes to REB procedures and considerations are detailed. Social implications What the authors have discovered is that it is not just about academic or institutional REB decolonization: there are broad systematic issues at play. However, pursuing the collective responsibilities outlined in our paper should work towards empowering communities to build their own consensus around research with/in their people and their lands. Indigenous peoples are rights holders, and have governance over research, including the autonomy to make decisions about themselves, their future, and their past. Originality/value The value is in its guidance around how authentic partnerships can develop that promote equity with regard to community and researcher and community/researcher voice and power throughout the research lifecycle, including through research ethics reviews that respect Indigenous rights, world views and ways of knowing. It helps to show how both Indigenous and non-Indigenous institutions can collectively honour Indigenous rights holders through ethical research practice.

Understanding early childhood education and care utilization in Canada: implications for demand and oversight

This study examined early childhood education and care (ECEC) utilization in Canada, focusing on use of unlicensed home child care (HCC) from an equity perspective. Data from the 2011 cycle of the General Social Survey (GSS) were used. Across Canada, parent responses reveal that 16.6% of children between the age of 12 months and entry to school were in unlicensed HCC. Another 24% of working parents reported having no regular form of non-parental childcare. Families with higher incomes were more likely to report using center-based care. Conversely, lower-income working parents with lower levels of education were more likely to use unlicensed HCC or report using no non-parental care at all. Comparison of parent responses in Ontario, however, where government estimates for the number of licensed and unlicensed HCC spaces are available, revealed that more parents report that their children are in licensed HCC than is possible. The lack of accurate parental reporting calls into question a key assumption of current regulatory systems, which is that parents are informed consumers of ECEC services. Given that many parents misreport the type of HCC their children use, and the equity concerns raised by the overall utilization patterns we found, we argue that governments need to take a more active role in oversight and support of HCC.

Current state and development trends of domestic medical device market for in vitro diagnostics in the segment of diagnostic reagents and their kits.

The problem of import substitution in the Russian medical device market for in vitro diagnostics (MDivd) has not been solved, despite a number of measures taken by the government of the Russian Federation since 2011. The reasons hampering this process are the lack of modern analytical equipment of domestic production and deficiencies of the current regulatory system for MDivd circulation in the market. It is proposed the transition from licensing system of MDivd registration to notification system as a radical measure to solve the problem of import substitution.

Institutional conditions of interaction of financial-credit and innovative economic sectors

In this article, the authors consider one of the most important issues in the development of the Kazakhstani economy - strengthening the innovation component, capable of ensuring economic growth regardless of export revenues of the oil and gas sector of the country. According to the authors, the solution of this strategic task directly depends on the vector of state regulation, which should be characterized by integration and proportionality in ensuring more active and productive interaction of subjects of financial and credit and real (including innovation) sectors of the economy. In this regard, the authors, based on the use of a systems approach and the theory of institutionalism, carried out economic and mathematical modeling on data from a number of countries, allowing to determine the degree of influence of regulatory institutional measures on the quality of interaction between the subjects of these sectors. The obtained results allowed formulating a number of conclusions that can be a starting point in terms of improving the current regulatory system in the Republic of Kazakhstan.

How to Regulate Bitcoin? Decentralized Regulation for a Decentralized Cryptocurrency

Bitcoin is a distributed system. The greatest dilemma it poses to the current legal and regulatory systems is that it is hardly possible to regulate a distributed network in a centralized fashion as decentralized permissionless blockchain-based cryptocurrencies are antithetical to the existing centralized structure of monetary and financial regulation. By shifting the policy debate from whether to regulate bitcoin and other decentralized cryptocurrencies to how to regulate them, this paper proposes a more nuanced policy recommendation for regulatory intervention in the cryptocurrency ecosystem. This policy approach relies on a decentralized regulatory architecture that is built upon the existing regulatory infrastructure and makes use of the existing as well as the emerging middlemen in the industry. It argues that instead of regulating the technology or the cryptocurrencies at the code or protocol layer, which might not be desirable, even if feasible, the regulation should target the applications and use-cases of cryptocurrencies. Such a regulatory strategy can best be implemented through directing the edicts and interdictions of regulation towards the middlemen, and can be enforced by the existing financial market participants and traditional gatekeepers such as banks, payment service providers and exchanges, as well as new emerging participants, such as large and centralized node operators and miners that are likely to replicate the functions of the traditional gatekeepers.

방송의 객관성 규제수단에 관한 고찰 - 현행 규제수단에 대한 법률적 검토를 중심으로 -

방송의 객관성 규제수단에 관한 고찰 - 현행 규제수단에 대한 법률적 검토를 중심으로 -

Challenges and potential solutions to the evaluation, monitoring, and regulation of surgical innovations

BackgroundAs it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems.Main BodyIn this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture.ConclusionWe conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.

Needs Assessment: Watershed Science for Water Resources Directors

We conducted a needs assessment to identify watershed science training needs for locally elected directors of Nebraska's 23 natural resources districts (NRDs). We interviewed NRD staff and surveyed NRD directors to determine training needs and identify relevant topics and preferred delivery formats. We found that training would be valuable; however, directors are busy, meaning that opportunities for training are limited. Additionally, we learned that directors rely on printed material and other NRD personnel for watershed science information. Therefore, web-based information may be most useful if designed for collaborative learning through hybrid delivery during regular NRD activities. Our findings are relevant to current and future regulatory systems reliant on locally elected boards.

STABILITY OR DEVELOPMENT: WHAT CAN ENSURE TODAY THE ECONOMIC SECURITY OF RUSSIA?

Today in Russia pension, tax, credit and other financial initiatives of the government significantly change economic and social norms for the population. The latter forms contradictions and risks of the current financial policy of the government, which constrain the solution of the problem of «achieving growth rates above those of the world» and reduce the level of political stability in the society. This requires a thorough study of the directions of financial policy, within which has formed a number of significant obstacles to the solution of social, economic, innovative and other strategic objectives of the development of our country and its regions. On the basis of statistical analysis, the article substantiates why modern budget concept is not focused on the creation of the necessary conditions for the development of “breakthrough” growth rates of Russian economy. The paper shows what defects and contradictions of the current system of budget regulation hinder the implementation of the tasks of ensuring economic and national security of the country. The authors prove the basic directions of reforming the current budget concept of the RF Government.

Genetic modification in Malaysia and India: current regulatory framework and the special case of non-transformative RNAi in agriculture.

Recent developments in modern biotechnology such as the use of RNA interference (RNAi) have broadened the scope of crop genetic modification. RNAi strategies have led to significant achievements in crop protection against biotic and abiotic stresses, modification of plant traits, and yield improvement. As RNAi-derived varieties of crops become more useful in the field, it is important to examine the capacity of current regulatory systems to deal with such varieties, and to determine if changes are needed to improve the existing frameworks. We review the biosafety frameworks from the perspective of developing countries that are increasingly involved in modern biotechnology research, including RNAi applications, and make some recommendations. Malaysia and India have approved laws regulating living modified organisms and products thereof, highlighting that the use of any genetically modified step requires regulatory scrutiny. In view of production methods for exogenously applied double-stranded RNAs and potential risks from the resulting double-stranded RNA-based products, we argue that a process-based system may be inappropriate for the non-transformative RNAi technology. We here propose that the current legislation needs rewording to take account of the non-transgenic RNAi technology, and discuss the best alternative for regulatory systems in India and Malaysia in comparison with the existing frameworks in other countries.

СОВЕРШЕНСТВОВАНИЕ МЕТОДОЛОГИЧЕСКИХ ОСНОВ ПОСТРОЕНИЯ НОРМАТИВНОЙ БАЗЫ ТЕХНИЧЕСКОГО РЕГУЛИРОВАНИЯ В ОБЛАСТИ КОНСТРУКТИВНЫХ И ОБЪЕМНО - ПЛАНИРОВОЧНЫХ РЕШЕНИЙ ОБЩЕСТВЕННЫХ ЗДАНИЙ

The issue of technical regulation in the development of constructive and space-planning decisions for public buildings is considered. The paper’s aim is to analyze the current system of technical regulation in the Russian Federation, to highlight it in the structure of regulatory documents relating to the development of project documentation "constructive and space-planning decisions" of public buildings. The need for such an analysis is determined by the absence of a unified information base of standards, the inconsistency of requirements in the documents of various departments and the lack of rapid updating of databases. Development of constructive and space-planning decisions of the designed public building is a fundamental component of the initial stage of an investment process. Therefore, the regulatory framework is necessary to provide the designer with operational information for the preparation of high-quality project documentation, reducing the number of expert comments to the adopted design decisions, the time frame for updating the design decisions and the investor's subsequent costs of operating the capital construction object. The analysis and evaluation of the effectiveness of the system present the authors’ point of view on its further improvement by creating a new model for organizing the structure of the regulatory framework for technical regulation documents of public building, which should include blocks of standards for each type of public buildings

Medicinal Cannabis: Issues of evidence

IntroductionMedicinal cannabis has been used for over 6000 years. It may be accessed legally in many western countries, yet in Australia, access is very difficult. It is treated as a pharmaceutical and an ‘unapproved therapeutic good’, and is subsequently subject to a complex regulatory system around prescribing. There have been calls by authoritative bodies in Australia for more evidence in relation to its efficacy and safety, suggesting that this is inadequate. The adoption of the evidence-based medicine (EBM) approach as the basis of decision-making in the healthcare sector positions systematic reviews and randomised controlled trials (RCTs) at the top of the hierarchy of evidence. It is largely this form of evidence that has been used to argue for or against the efficacy and safety of cannabis and to substantiate the current regulatory system in Australia. It is therefore important to understand the EBM approach and factors that need to be considered when examining scientific research into cannabis, in order to decide whether there is sufficient evidence or not. It is argued that regulation of cannabis is inappropriate, based on a limited understanding of evidence, and continues to limit access to medicinal cannabis by patients. MethodsThis paper examines the notion of evidence in medicine, points of consideration in scrutinizing research methodology, what the actual evidence is in relation to safety and efficacy of medicinal cannabis, the implications of evidence and whether it supports the current regulatory framework around medicinal cannabis in Australia. It poses an alternative regulatory approach. ResultsA robust definition of EBM goes beyond the notion of simply scientific evidence in the form of RCTs and systematic reviews. Rigorous scrutiny of the evidence about cannabis is required, since evidence is being used to control access. Scientific evidence including reports from authoritative bodies indicates there is much evidence to support the safety and efficacy of medicinal cannabis. CBD has been found to be relatively safe, non-addictive and efficacious. Access to medicines that alleviate suffering in a timely manner is a human right and a medical responsibility. There is enough evidence to justify regulatory changes to significantly increase access to medicinal cannabis in Australia. ConclusionWe need to bring back the human element when considering what evidence we use and how we use it in medicine. Cannabis has the potential to alleviate much suffering, and patient (human) rights must be central in public policy. There is already much scientific evidence in relation to safety and efficacy of cannabis and cannabinoids such as CBD and THC. In Australia, the current regulatory system needs to be disbanded, cannabis products treated as ‘approved goods’ and regulated as complementary medicines (for products containing CBD and low THC) or in the case of high THC-containing products, regulated under the SUSMP as an S4 (rather than S8) medicine.