National Regulatory Bodies Research Articles

Developing an alcohol policy assessment toolkit: application in the western Pacific.

ObjectiveTo demonstrate the development and feasibility of a tool to assess the adequacy of national policies aimed at reducing alcohol consumption and related problems.MethodsWe developed a quantitative tool – the Toolkit for Evaluating Alcohol policy Stringency and Enforcement (TEASE-16) – to assess the level of stringency and enforcement of 16 alcohol control policies. TEASE-16 was applied to policy data from nine study areas in the western Pacific: Australia, China excluding Hong Kong Special Administrative Region (SAR), Hong Kong SAR, Japan, Malaysia, New Zealand, the Philippines, Singapore and Viet Nam. Correlation and regression analyses were then used to examine the relationship between alcohol policy scores and income-adjusted levels of alcohol consumption per capita.FindingsVast differences exist in how alcohol control policies are implemented in the western Pacific. Out of a possible 100 points, the nine study areas achieved TEASE-16 scores that ranged from 24.1 points for the Philippines to 67.5 points for Australia. Study areas with high policy scores – indicating relatively strong alcohol policy frameworks – had lower alcohol consumption per capita. Sensitivity analyses indicated scores and rankings for each study area remained relatively stable across different weighting schemes, indicating that TEASE-16 was robust.ConclusionTEASE-16 could be used by international and national regulatory bodies and policy-makers to guide the design, implementation, evaluation and refinement of effective policies to reduce alcohol consumption and related problems.

Minor ailments and self-limiting conditions: NOT.

Pharmacists in Canada from coast to coast to coast are beginning to exercise new expanded scopes of clinical practice. We have come such a long way in the development of our clinical services to our patients, and as we all work together towards entry-level PharmD implementation in Canada, a “renaissance” in the profession of pharmacy is evident. Pharmacists have always exercised a great deal of careful oversight and scrutiny in the professional accuracy of our profession. Indeed, this is part of the “DNA” of a successful pharmacy practitioner. However, in recent years, I have heard the terms “minor” ailments and “self-limiting” conditions, used by pharmacists, governments and national pharmacy regulatory bodies in Canada and abroad. I do not believe that we have exercised optimal judgment over the adjectives associated with some pharmacy services that we are providing. I cringe whenever I hear the use of the word “minor.” I find it professionally demeaning to pharmacists and our patients. The Oxford dictionary (www.oxforddictionaries.com/definition) defines “minor” as an adjective: “Lesser in importance, seriousness or significance.” Synonyms include “unimportant, insignificant, negligible, trivial, and petty.” “Self-limiting” is also an adjective: “Relating to or denoting something which limits itself, in particular: Medicine (of a condition) ultimately resolving itself without treatment: Money is wasted on prescriptions for self-limiting illnesses.” Pharmacy as a profession is being reconceptualized in the 21st century, and we have made great strides. Certainly, there is a bright future ahead; however, we must ensure that the monikers that we choose to use to describe ourselves are professionally appropriate, accurate and less restrictive. As pharmacists are clearly taking on greater roles in the area of primary care and given the walk-in, accessible nature of pharmacies/pharmacists to our patients directly and caregivers by extension, we should consider using alternative appellatives such as “ambulatory ailments.” The Oxford dictionary defines “ambulatory” as “related to or adapted for walking: 1.1 Another term for ambulant (of a patient) able to walk about; not confined to bed. 1.2 Movable; mobile.” This label could more accurately describe many of our patients without undermining the seriousness of their afflictions and the professional importance of pharmacist services and training. I am open to suggestions on the terminology that we ultimately invoke but strongly advocate that the profession of pharmacy use the most ideal adjectives available as we continue to serve our patients. We should also leave room for embracing future changes, expansion and evolution in our practice directions. Ultimately, all of this is about more than just labels and name changes; it is about empowering ourselves as a profession rather than allowing ourselves to be put down while embracing our ever-expanding scope of practice. Clearly, we may have to work harder at redefining how we are seen and how we want to be perceived as part of the health care team. It is at our foundation and at the core of the pharmacy profession that we must carefully frame and word our pharmacy ministry. Ab initio in this reflective process and integral to how we see ourselves as a profession and portray ourselves to others, we should carefully reconsider perpetuating the use of the adjectives “minor” and “self-limiting” in the clinical services that pharmacists provide to our patients and society.

Current role of research ethics committees in health research in three geopolitical zones in Nigeria: A qualitative study

Background. Ethics are rules or standards governing the conduct of a person or members of a profession. Medical research must be regulated to ensure that fundamental human rights are not breached in the quest for knowledge. Nigeria had no laws or specific guidelines to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee (NHREC), was established. Its function is to ensure ethical conduct in research and to accredit institutional and state health research ethics committees (HRECs). Objective. To document the current role of HRECs in the ethical practice of health research in Nigeria, 4 years after the establishment of the NHREC. Methods. Functioning of the HRECs was evaluated via interviews of 14 members of state and institutional HRECs chosen from selected geopolitical zones of the country. Results. The HRECs surveyed had between nine and 15 members, with more males than females. Review meetings were held only occasionally owing to the competing interests of members, who receive no incentives for participation, and poor funding. Scientific and ethical reviews are conducted together by the same committee, but few members of the HRECs are trained in research ethics. Monitoring of research after approval is poor. Conclusion. Nigeria now has about 30 institutional HRECs, but their functioning is hampered by a shortage of both money and qualified individuals to serve on them.

Unrelated adult stem cell donor medical suitability: recommendations from the World Marrow Donor Association Clinical Working Group Committee

The World Marrow Donor Association (WMDA) fosters collaboration between international registries to facilitate the exchange of hematopoietic stem cell products for unrelated stem cell donor transplantation. As indications for hematopoietic SCT grow, the movement of products across the world will increase. Although competent authorities may regulate products within their country, there is a need to protect the best interests of donors and recipients by identifying universal donor medical suitability criteria. Within this report the WMDA provides a background to unrelated adult donor and recipient safety, recommends a common framework for assessing the health of unrelated adult donors at each stage of the donation pathway and presents a novel mechanism for sharing international consensus criteria for individual medical and lifestyle conditions. Wherever possible, these criteria are evidence-based. By establishing a donor medical suitability working group, the WMDA has developed a process through which donor centers and registries may request a consensus opinion on conditions not already listed, as well as challenge existing criteria. Guidance from the WMDA is intended to complement, not supersede, guidance from national competent authorities and international regulatory bodies.

Enhancing the Auditor's Report: To What Extent is There Support for the IAASB's Proposed Changes?

SYNOPSIS This article outlines proposed reforms to auditor reporting currently being considered by the International Auditing and Assurance Standards Board (IAASB), and other key national and transnational standard-setters and regulatory bodies. It adds to recent academic contributions on reforming the auditor's report by analyzing the 165 stakeholder responses to the IAASB's 2012 Invitation to Comment: Improving the Auditor's Report to determine levels of support for the IAASB's proposed reforms, and the differences, if any, between the views of various respondents based on stakeholder groups (e.g., audit and assurance firms, users, preparers, regulators, etc.) and regional classifications. Guided by insights from communication theory, our results show the levels of stakeholder support for the IAASB's proposed reforms addressing auditors' expectations, information, and communication gaps are mixed. The strongest overall support was for enhanced auditor reporting on other information attached to, or intended to be read with, the financial statements, and the least supported initiative was including additional information in the auditor's report about the auditor's judgments and processes. While overall there is generally consensus across both stakeholder groups and regions concerning the various questions investigated, we highlight where statistically significant differences between groups do exist. Notably, North American respondents were less likely to support a number of the IAASB's proposed reforms than their counterparts from other regions. Data Availability: The data used in this study are referred to on the IAASB's website.

Health-Related Quality of Life After Transcatheter or Surgical Aortic Valve Replacement in High-Risk Patients with Severe Aortic Stenosis: an Updated Review of Literature

Recent trials have highlighted the comparable mortality benefits and durability of the results for patients with severe aortic stenosis (AS) and high surgical risk managed with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Various national guidelines and international regulatory bodies have approved TAVR, thereby leading to potential wide usage and dissemination of this technique worldwide. Quality-of-life outcomes, in spite of being an important measure of success and acceptability of the procedure, have not been publicized as extensively. For high risk patients with severe AS, implementation of TAVR has resulted in comparable survival, but different and novel adverse events compared with AVR. We present an updated review focusing on the quality-of-life outcomes and issues with this new and important procedural approach.

RESOLUTION-LESS CONFLICT AND SHIFTING ALIGNMENTS IN MUNICIPAL AIR TOXICS DISPUTES: THE CASE OF HOUSTON UNDER THE WHITE ADMINISTRATION, 2004–2009

Convinced that state and national regulatory bodies were not doing enough to control airborne toxic pollution, the City of Houston, Texas, led by a newly elected Mayor, implemented an aggressive pollution-reduction campaign from 2004–2008. The City provoked controversy over the presence and extent of an air toxics problem in Houston, first, by contesting the meaning of available scientific evidence, and then, by advocating for more stringent regulatory controls to address it. The controversy involved many different participants, and a shift from their ex ante consensus, as each was moved to support its claims with analyses and re-interpretations of scientific evidence. The City's attempt to expand its role in the regulation of air toxics, in large part through discursive means, met with considerable resistance and prompted realignments among participants. This case study examines how this came about, highlights the unorthodox features of the dispute and accounts for the absence of a conventional consensus-based resolution.

Overview of Problems Associated with Ineffective Enforcement of Market Abuse Provisions in South Africa

South Africa had anti–market abuse legislation in place since the late 1990s but nonetheless the enforcement of such legislation to combat market abuse activities has been inconsistent and problematic to date. The objective of this article is to provide an overview analysis of some factors that have to date contributed too many challenges that are associated with the inconsistent enforcement of the market abuse laws in South Africa. This is primarily done to increase awareness on the part of the general public, policy makers and other relevant stakeholders and to innovate possible solutions to such challenges in order to enhance the enforcement of the market abuse ban in South Africa. In relation to this, the article seeks to explore these enforcement problems by, first, taking a closer look at the effectiveness of the Financial Services Board (the FSB) as the market abuse national regulatory body in South Africa. Secondly, the co–operation between the FSB and other similar local and international enforcement bodies will be examined. Thirdly, the adequacy of the available resources, penalties and remedies will be discussed. Lastly, the adequacy of the market abuse preventative measures that were adopted in South Africa will be discussed. DOI: 10.5901/mjss.2014.v5n4p47

Legal Issues of the Public Administration in Ukraine in the Context of Constitutional and Public Administration Reforms

The system of the public administration in Ukraine needs to be improved based on the theoretically proven concept. The legal nature, the organizationally-legal forms of entities of the public administration, in particular, of such special state bodies as central state bodies of executive power with special status and national regulatory authorities, are among the most discussible issues. Based on the analysis conducted in this paper, the conclusion about the necessity of the relevant criteria for the establishment of different organizationally-legal forms of central state bodies of executive power has been made. There is a separate group of bodies within the system of central state bodies of executive power that has the special scope of competence, special relations with the Government of Ukraine, the special procedure of establishment, reorganization and liquidation, as well as the special procedure of appointment and dismissal of the chairmen of the bodies – central state bodies of executive power with special status. However, such bodies have a transitional character; their existence within the system of the bodies of executive power seems to be artificial. Therefore, it is recommended to exclude such bodies from the system of bodies of executive power. The author of this paper supports the establishment of the separate group of independent regulatory authorities (that should include, in particular, the Antimonopoly Committee of Ukraine, regulatory commissions in the spheres of energy, utilities, telecommunications, bonds and financial markets) within the system of the public administration of Ukraine. However, the legal framework for such national regulatory authorities is still stipulated only by laws and regulations. Therefore, it is proposed to amend the Constitution of Ukraine with the provisions on independent regulatory authorities, and, in particular, to share the responsibilities regarding the appointment and dismissal of the chairmen and the members of such bodies between the Parliament and the President of Ukraine, to stipulate that the framework for establishment and functioning of these organs shall be stated only by laws of Ukraine, to define that the national regulatory bodies shall be accountable to the Parliament of Ukraine and to the President of Ukraine and to stipulate the strict requirements of such accountability by laws.

Political regulations to advance health care system

Through the support of the Alexander von Humboldt Foundation (Prof. Dr. Lotta Salminen of Finland and the host supervisor Prof. Dr. Olga Golubnitschaja of Germany were awarded fellowship), in the years 2012–2013, EPMA has performed a specialised project focused on the collaboration among PPPM-related professional groups and policymakers. This project is aimed to identify problems and deficits in health care of common and pandemic chronic diseases such as type 2 Diabetes mellitus. Interviews performed with the experts from all countries of the European Union, Israel, Russia and Turkey resulted in the conclusion that one of the common deficits is missing communication and collaboration between health care professionals and decision-makers. Moreover, there are difficulties in accessing national regulatory bodies to enhance the message of patient-focused health care. This evidence demonstrates that decisions in the health care sector are generally made without consideration of accumulated professional knowledge. This may explain the lack of sufficient efficacy currently observed in health care systems. The completed report with the collected data that resulted from this project is currently prepared for publication in The EPMA Journal (2014). In contrast, if well established, the collaboration with governmental institutions may lead to the crucial reconsideration of current national and European guidelines for health care relevant research activities and medical services. There are following emerging issues to be reconsidered in health care: 1. Promoting research fields focused on the patient needs 2. Mandating a paradigm shift from reactive to predictive and preventive medicine 3. Creating specialised state budgets to target preventive measures against pandemic incidence of common chronic diseases 4. Forcing an effective implementation of innovative predictive diagnostics 5. Creating new educational programmes for professionals to implement integrative medical services in predictive, preventive and personalised medicine 6. Creating educational measures to increase the understanding of innovative diagnostic technologies and targeted preventive measures in the general population 7. Creating new economic models to motivate health responsibility. As health care is subject to national subsidiarity, there are substantial variations in the level of provision in different countries. However, corresponding standards might be introduced at the European level to promote inter-European mobility and to avoid economic discrepancies and conflict of interest [1,2].

Linking regulation of practitioner school psychology and the United Nations Convention on the Rights of the Child: The need to build a bridge

In 2014, the 25th anniversary of the United Nations Convention on the Rights of the Child presents an opportunity for school psychology to evaluate its achievements relevant to the Convention, as well as its current and future strategic adherence to the Convention’s principles. With analysis of key school psychology documentation from the UK, it is shown that for school psychologists the achievements and strategy relating to the international Convention have been directly, albeit implicitly, supported from ‘top down’, by the post-ratification governance processes and structures of national level agencies which operate school psychology preparation, statutory professional regulation, and non-statutory professional quality enhancement. On account of their use of a scientist-practitioner model, school psychologists are positioned to make a unique contribution to enacting the Convention’s agenda and from recent Convention evaluations five priority areas for strategic development in relation to the Convention are identified. An account of the authors’ commissioned work following a non-accidental child death in the UK illustrates how school psychologists can make significant contributions to Convention priorities from ‘bottom up’ as a result of significant contemporaneous events at local or national level. Implications of the ‘top down’ and ‘bottom up’ linking of school psychologists’ work with the CRC agenda are discussed with reference to both the national and international school psychology communities and regulatory bodies.

The importance of proficiency testing schemes for the performance improvement of medicines quality control laboratories

In the last few decades proficiency testing schemes (PT schemes) have become especially important for the testing and calibration laboratories performance improvement, as well as one of the prerequisites for the successful accreditation of laboratories. This paper explains the particular significance of PT scheme for medicines quality control laboratories, which are participating only in the PT schemes organized by the European Directorate for the Quality of Medicines and Healthcare. Also, the paper describes the essential prerequisites for accreditation of the first national PT provider in the field of medicines quality control, as well as the quality assurance aspects of a PT scheme in this area. National Control Laboratory has the necessary resources and the required competence for the organization and implementation of the PT scheme, and may be accredited as a provider PT. It was pointed out that the participation of quality control laboratories belonging to the pharmaceutical industry in these studies represented a distinct improvement in the strengthening of trust between the pharmaceutical industry and the national regulatory body, because the results of PT schemes would be used for educational purposes only in order to improve and harmonize methods for analysis of drugs that are on the national market.

The Effects of IFRS on Net Income and Equity: Evidence from Romanian Listed Companies

IFRS adoption in Europe represents a major milestone towards financial convergence and Romania, as European member state, had in the last few years a positive reaction towards this process. Starting with year 2012, Romania imposed trough its national regulatory body (the Ministry of Finance) the presentation of individual financial statements according to IFRS for 67 Romanian listed companies. The main concern has been to understand the most important differences between national accounting rules and IFRS and how these could affect their reported performance. The goal of the paper is to address this concern by highlighting some empirical evidence of the differences between Romanian accounting regulation and IFRS. These differences are identified in the reconciliation of shareholders’ equity and net income of the Romanian listed companies in order to present the significant impacts of the conversion to IFRS. The conclusion of this study is that for all 67 companies, presented in our study, the application of IFRS had a small effect on net income and shareholders’ equity.

Using data and quality monitoring to enhance maternity outcomes: a qualitative study of risk managers’ perspectives

IntroductionRisk management is a core part of healthcare practice, especially within maternity services, where litigation and societal costs are high. There has been little investigation into the experiences and opinions...

European Council formally adopts regulations to ease movement of doctors

The European Council has formally adopted new regulations to make it easier for doctors and other health professionals to work in other European countries. The sign-off on the revised Directive on Mutual Recognition of Professional Qualifications on 15 November marks the conclusion of an approval process that began in 2011. European Union countries will now have two years to pass the directive into national law. The General Medical Council has welcomed the move, saying that the new regulations will enhance the safety of patients. The updated directive will permit national regulatory bodies to check the language skills of health professionals when a concern is raised during the registration process and to test their linguistic ability where necessary before allowing them to practise. A GMC spokesperson told …

Ensuring the Global Availability of High-quality Dental Restorative Materials

The Minamata Convention, a global legally binding instrument (treaty) on mercury, has been the catalyst for the emerging agenda on global dental materials research. If the current and future challenges of oral health maintenance and healing on a global scale are to be met, a logical and effective research agenda for the discovery and introduction of new, environmentally sustainable, dental materials must be developed through a coordinated effort involving materials scientists, dental clinicians, representatives of industry, members of regional and national regulatory bodies, and advocacy from research organizations. For universal impact, this agenda should be created with awareness of several important ongoing initiatives, such as the WHO non-communicable diseases action plan, the UN sustainable development agenda, and the IADR Global Oral Health In Inequalities Research Agenda (GOHIRA). A significant contributor to this cause is the FDI and its membership, who, through their Vision 2020 initiative, acknowledge their role and responsibility in globally preventing and managing dental disease and providing leadership to the profession in terms of information dissemination and affecting change. Dental researchers also have an obligation to advocate for appropriate funding to match the identified research needs, thus enhancing the possibility that key decision-makers will provide the needed support to achieve the research agenda agreed upon by this diverse group of stakeholders.

Licensing small modular reactors

Small modular reactor designs with power levels of less than 300 MWe are being developed in several countries. While there are several potential advantages with these reactors, they are also confronted with multiple challenges. Important among these challenges is to have these new reactor designs licensed by national regulatory bodies. Because of the many novel features incorporated in different SMR (small modular reactor) designs, careful and thorough licensing procedures are critical to maintaining safety of the nuclear fleet. This paper examines how different countries have engaged in the process of licensing new reactor designs, and demonstrates both similarities and differences between countries. In many cases, designers have emphasized the safer design and deployment features of SMRs and attempted to use those features as reasons to get existing licensing requirements diluted. This raises the concern that the promised safety enhancements in SMR designs could be offset by a simultaneous relaxation of licensing requirements.

Regulatory perspectives on medical device approval in global jurisdictions

Today medical device sector is evolving to find the new horizons. Medical device approval is a time-consuming process that requires submission of safety, efficacy and quality documentation to national regulatory bodies in various countries. While there are some similarities among the countries regarding medical device regulations, some differences also exist that significantly affect the regulatory scrutiny. This presents a great problem for manufacturers marketing their products in multiple countries. Competent authorities worldwide have begun to realize the problem and collaborate to harmonize the regulations. In the present article regulatory approval procedure is discussed in different jurisdictions such as United States, European Union, Japan, China and India along with comparisons in terms of classification of devices, competent authorities, rules and regulations and quality management systems involved in these countries.

Animal models for bench to bedside translation of regenerative cardiac constructs

Investigators seeking to select an animal model for use in preclinical research studies prior to FDA submission for allograft heart valves have several types to choose from. Dogs, pigs, cattle, primates and sheep have all served as successful medium and large animal models, and their murine counterparts have also been integral in the advancement of replacement heart valve research. While the national and international regulatory bodies have not specified a universal animal model for use in preclinical research studies, the ovine and porcine models have become the frontrunners within the peer-reviewed literature. Sheep are an excellent model of bioprosthetic valve calcification, with a robust mineralization response that mimics observations of human clinical disease progression, while swine are the model of choice for valves which pose a risk of thrombotic events. In the rapidly advancing field of tissue engineered cardiovascular products, dogs, primates, rodents, sheep and pigs are all valuable models for the study of scaffold remodeling and recellularization. Once an animal model has been chosen, investigators are recommended to consult with the FDA via submission of a Request for Designation in order to identify the type of product and the appropriate Center to which the product should be submitted. Additionally, the investigator should outline a risk analysis plan that categorizes the failure modes of the product, as well as design an in vivo pre-clinical safety and performance study that will capture data applicable to the assessment of the failure modes enumerated in the risk analysis.

Allergen Immunotherapy Extract Treatment Set Preparation: Making a Safer and Higher Quality Product for Patients

The best possible allergen immunotherapy clinical outcomes require the provision of high quality and safe allergen immunotherapy extract preparations. Evolving national guidelines and regulatory bodies have devoted special attention to the safe compounding of sterile products, including allergen extracts. It is incumbent upon allergists preparing extract treatment sets for patients to be familiar with and adopt training, procedures and safety measures that lead to standardized high quality products. Preparers and supervisors must maintain ongoing competency in aseptic technique and prescribing principles, such as probable effective dose ranges, allergen cross-reactivity, and separation of high protease-containing extracts from susceptible extracts. Accordingly, knowledge and application of vial labeling, diluent selection, standard operating procedures, mixing log documentation, and mixing condition principles are a necessity. Although there have been no instances of infectious complications from allergen immunotherapy in a century of clinical practice, continued vigilance in the use of measures that ensure extract sterility is paramount. A review of allergen immunotherapy preparation recommendations and best practices based on published national guidelines is presented. Further study of preparation measures and prescribing principles will continue to advance the practice of allergen immunotherapy and offer opportunities for refinement of current recommendations.