The article engages with the recent studies on multilevel regulation. The starting point for the argument is that contemporary multilevel regulation—as most other studies of (postnational) rulemaking—is limited in its analysis. The limitation concerns its monocentric approach that, in turn, deepens the social illegitimacy of contemporary multilevel regulation. The monocentric approach means that the study of multilevel regulation originates in the discussions on the foundation of modern States instead of returning to the origins of rules before the nation State was even created, which is where the actual social capital underlying (contemporary) rules can be found, or so I wish to argue. My aim in this article is to reframe the debate. I argue that we have an enormous reservoir of history, practices, and ideas ready to help us think through contemporary (social) legitimacy problems in multilevel regulation: namely all those practices which preceded the capture of law by the modern State system, such as historical alternative dispute resolution (ADR) practices.
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Alternative dispute resolution (ADR) is constantly gaining ground, both at domestic and international level. New forms of dispute settlement with a mix of public and private components are emerging in fields where this was not the case until recent times, as some contributions to this Zoom-out have attempted to demonstrate. In the field of investment law we have witnessed a somehow opposite trend. Traditionally, disputes in this field have been settled by means of arbitral tribunals established mostly on the basis of bilateral or multilateral investment agreements (IAs) under a variety of arbitration facilities, which are collectively referred to as investor-to-State dispute settlement (ISDS). Traditional ISDS presents many characteristics of ADR, starting from the strong role that private parties play in it (for example when it comes to the appointment of arbitrators). The practice has shown that the system has clear advantages but also undeniable disadvantages. The prevailing opinion in recent years has been that the latter considerably outweigh the former, resulting in what has been termed the backlash against investment arbitration in a volume appeared a few years ago. In this contribution, how-ever, I will not dwell on the details of the crisis that has affected investment arbitration, nor will I engage in a discussion of whether that backlash is entirely justified. My focus will be much more modest. One of the most tangible consequences of this growing dissatisfaction towards investment arbitration is the launch on the part of the EU of a court-like system to settle investment disputes –the now famous investment court system (ICS) –as a replacement to old-fashioned ISDS. The ICS now features in all EU IAs, and has become the standard position of the EU when it comes to dispute settlement in this field. Recently, the ICS has also received the green light of the European Court of Justice (ECJ),raising doubts as to whether traditional ISDS has conclusively been sent to oblivion, at least in the EU. From a political and policy perspective, it is undoubtful that there is a strong stance on the part of the EU and of its Member States against traditional ISDS. This article, however, will focus exclusively on the legal dimension, by examining whether the ECJ’s decision should be read as meaning that investment arbitration is incompatible with the EU legal system. While itis clear that Opinion 1/17 means that the ICS is compatible with EU law, it remains to be seen whether the Court’s finding allows an a contrario reading. Namely, whether it entails the incompatibility with EU law of traditional ISDS. The analysis will start with a brief summary of the events and developments that preceded the creation of the ICS and eventually led to the current situation (Section 2), followed by an examination of the relevant parts of Opinion 1/17 (Section 3). This part will be followed by an appraisal of the possible legal implications of the decision (Section 4). Some conclusions will be offered in the closing section (Section 5) in the attempt to look beyond the boundaries of EU law. Part of topic "The blurring distinction between public and private in international dispute resolution"
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The Junior Adverse Drug Event Manager (J-ADEM) team is a multifaceted intervention focusing on real-life education for medical students that has been shown to assist healthcare professionals in managing and reporting suspected adverse drug reactions (ADRs) to the Netherlands Pharmacovigilance Centre Lareb. The aim of this study was to quantify and describe the ADRs reported by the J-ADEM team and to determine the clinical potential of this approach. The J-ADEM team consisted of medical students tasked with managing and reporting ADRs in hospitalized patients. All ADRs screened and reported by J-ADEM team were recorded anonymously, and categorized and analysed descriptively. From August 2018 through January 2020, 209 patients on two wards in an academic hospital were screened for ADR events. The J-ADEM team reported 101 ADRs. Although most ADRs (67%) were first identified by healthcare professionals and then reported by the J-ADEM team, the team also reported an additional 33 not previously identified serious ADRs. In 10% of all reported ADRs, the J-ADEM team helped optimize ADR treatment. The ADR reports were largely well-documented (78%), and ADRs were classified as type A (66%), had a moderate or severe severity (85%) and were predominantly avoidable reactions (69%). This study shows that medical students are able to screen patients for ADRs, can identify previously undetected ADRs and can help optimize ADR management. They significantly increased (by 300%) the number of ADR reports submitted, showing that the J-ADEM team can make a valuable clinical contribution to hospital care.
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Abstract Specialist oncology nurses (SONs) have the potential to play a major role in monitoring and reporting adverse drug reactions (ADRs); and reduce the level of underreporting by current healthcare professionals. The aim of this study was to investigate the long term clinical and educational efects of real-life pharmacovigilance education intervention for SONs on ADR reporting. This prospective cohort study, with a 2-year follow-up, was carried out in the three postgraduate schools in the Netherlands. In one of the schools, the prescribing qualifcation course was expanded to include a lecture on pharmacovigilance, an ADR reporting assignment, and group discussion of self-reported ADRs (intervention). The clinical value of the intervention was assessed by analyzing the quantity and quality of ADR-reports sent to the Netherlands Pharmacovigilance Center Lareb, up to 2 years after the course and by evaluating the competences regarding pharmacovigilance of SONs annually. Eighty-eight SONs (78% of all SONs with a prescribing qualifcation in the Netherlands) were included. During the study, 82 ADRs were reported by the intervention group and 0 by the control group. This made the intervention group 105 times more likely to report an ADR after the course than an average nurse in the Netherlands. This is the frst study to show a signifcant and relevant increase in the number of well-documented ADR reports after a single educational intervention. The real-life pharmacovigilance educational intervention also resulted in a long-term increase in pharmacovigilance competence. We recommend implementing real-life, context- and problem-based pharmacovigilance learning assignments in all healthcare curricula.
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Abstract Managing adverse drug reactions (ADRs) is a challenge, especially because most healthcare professionals are insufficiently trained for this task. Since context-based clinical pharmacovigilance training has proven effective, we assessed the feasibility and effect of a creating a team of Junior-Adverse Drug Event Managers (J-ADEMs). The J-ADEM team consisted of medical students (1st–6th year) tasked with managing and reporting ADRs in hospitalized patients. Feasibility was evaluated using questionnaires. Student competence in reporting ADRs was evaluated using a case-control design and questionnaires before and after J-ADEM program participation. From Augustus 2018 to Augustus 2019, 41 students participated in a J-ADEM team and screened 136 patients and submitted 65 ADRs reports to the Netherlands Pharmacovigilance Center Lareb. Almost all patients (n = 61) found it important that “their” ADR was reported, and all (n = 62) patients felt they were taken seriously by the J-ADEM team. Although attending physicians agreed that the ADRs should have been reported, they did not do so themselves mainly because of a “lack of knowledge and attitudes” (50%) and “excuses made by healthcare professionals” (49%). J-ADEM team students were significantly more competent than control students in managing ADRs and correctly applying all steps for diagnosing ADRs (control group 38.5% vs. intervention group 83.3%, p < 0.001). The J-ADEM team is a feasible approach for detecting and managing ADRs in hospital. Patients were satisfied with the care provided, physicians were supported in their ADR reporting obligations, and students acquired relevant basic and clinical pharmacovigilance skills and knowledge, making it a win-win-win intervention.
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Calls for greater diversity, especially in relation to the appointment of arbitrators, have been prevalent for some time in the international arbitration community, followed by several initiatives being set up to address the issue. While the primary focus of the diversity debate has been on gender, there have also been calls to expand and diversify the profile of the arbitrator pool to include more non-Western and non-White arbitrators. For several years, scholars and practitioners have argued for countless benefits of increased racial diversity, such as an increased acceptability and legitimacy of the arbitration process. There is a consensus that in a deliberative process like ADR, practitioners should reflect their claimants’ demographics. The existence of diverse panels helps further the aims of meticulous and accurate fact-finding approaches. Similarly, they argue that the lack of racial diversity may directly and negatively affect the quality of arbitration awards. This blog post will focus on the lack of diversity of African arbitrators appointed to resolve international arbitration proceedings, as well as initiatives that are being set up to address such issues. The focus on African ethnicity is given for two reasons: 1) African countries are no strangers to arbitration. Nearly 100 arbitral institutions exist across Africa. 2) There has been an increase of arbitration proceedings emanating from African regions, while there has been a minimal growth in the ethnic diversity of arbitrators appointed to resolve these disputes. This article was originally published on https://commercialarbitrationineurope.wordpress.com/2021/06/29/diversity-in-arbitration-the-lack-of-racial-diversity-in-international-arbitral-tribunals/
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This study shows dentists' perception of AI in the Netherlands and the reasons why they use or do not use AI yet
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ABSTRACT Background: We investigated if the addition of an inter-professional student-led medication review team (ISP-team) to standard care can increase the number of detected ADRs and reduce the number of ADRs 3 months after an outpatient visit. Research design and methods: In this controlled clinical trial, patients were allocated to standard care (control group) or standard care plus the ISP team (intervention group). The ISP team consisted of medical and pharmacy students and student nurse practitioners. The team performed a structured medication review and adjusted medication to reduce the number of ADRs. Three months after the outpatient visit, a clinical pharmacologist who was blinded for allocation performed a follow-up telephone interview to determine whether patients experienced ADRs. Results: During the outpatient clinic visit, significantly more (p < 0.001) ADRs were detected in the intervention group (n = 48) than in the control group (n = 10). In both groups, 60–63% of all detected ADRs were managed. Three months after the outpatient visit, significantly fewer (predominantly mild and moderately severe) ADRs related to benzodiazepine derivatives and antihypertensive causing dizziness were detected in the patients of the intervention group. Conclusions: An ISP team in addition to standard care increases the detection and management of ADRs in elderly patients resulting in fewer mild and moderately severe ADRs
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This paper investigates the prospective application of arbitration by Transnational Private Regulation (TPR). It builds on the study of TPR developed by Fabrizio Cafaggi et al. TPR addresses the ever-increasing transfer of regulatory power from national to global levels, and from public to private regulators. TPR entails private regulatory co-operation be-yond the jurisdictional boundaries of States through voluntary standards. The regimes of TPR are built by a variety of actors, such as companies, NGOs, independent experts, and epistemic communities. Examples of TPR can be found in food safety, forestry management, trade, and derivatives, among other fields. More specifically, they concern private actors engaging in transnational coordination of standard setting such as the Forest Stewardship Council (FSC) that was developed to foster responsible management of the world’s forests. There are four main characteristics of TPR: legitimacy, quality, effectiveness, and enforcement. I will describe those four characteristics in brief here. First, the legitimacy of TPR is built around consent through voluntary entry, participation, and exit of regulated entities. Important to this contribution is that the legitimacy of TPR goes beyond its legal dimension, measured by purely legal standards. Hence, the legitimacy of TPR is largely determined by standards developed by social and economic institutions relevant to specific TPR regimes. The role of those institutions in standard settings is higher in private TPR regimes than private-public TPR regimes, where some forms of compliance are mandatory. Second, the quality of TPR corresponds to the ex ante and ex post evaluation cycle of regulatory processes. It is also linked with the transparency of TPR. Third, the effectiveness of TPR is measured according to the extent to which the objectives of TPR (or selected TPR regimes) are met. And finally, enforcement of TPRis understood as ‘ensuring compliance with commitments’. Enforcement of TPR can take place through courts, administrative agencies, and private dispute resolution—including the arbitration at the core of this contribution. Cafaggi’s study identified rather selective use of arbitration in TPR, but also recommended changes to make arbitration law more adaptable to TPR. Furthermore, the study recommended that more specialized dispute resolution institutions are created to exclusively serve TPR. Against this background, I shift the main focus of analysis from TPR to arbitration. Whereas Cafaggi argued that arbitration may be suitable for TPR as a means of private enforcement, in this paper I go even further, arguing that arbitration as a means of informal, out-of-court dispute resolution is well suited to strengthen the normativity of TPR. This is so because private arbitration actors (including, inter alia, arbitrators and arbitral institutions) are already equipped with the tools necessary to facilitate cross-border TPR, which is done through informal standards and procedures with origins in the communitarian values and reputational mechanisms used by different communities before the development of modern States. The roots of most private justice regimes—including arbitration—are informed by communitarian values such as collaboration, participation, and personal trust. Those values, together with other core characteristics of arbitration correspond to all core characteristics of TPR, making both systems comparable and complementary. The analytical framework incorporated in this paper follows the four core characteristics of TPR. Hence, the paper is organized into five sections. The first section contains the introduction. In the second section, I analyze the legitimacy of arbitration vis-à-vis the legitimacy of TPR. In the third section, I investigate the accountability of arbitration as a means of quality signaling vis-à-vis TPR. In the fourth section, I focus on the remedies available to arbitrators in a view of TPR’s effectiveness. Finally, in the fifth section, I analyze enforcement through arbitration and its impact on the exclusiveness versus complementarity of TPR regimes. Conclusions follow, including recommendations for future research. Part of topic "The blurring distinction between public and private in international dispute resolution"
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Deze paper geeft antwoord op de vraag welke betekenis toegang tot recht heeft in wetenschappelijke literatuur, hoe dit in de wet verankerd en in beleid vorm krijgt en hoe zich dit verhoudt tot andere landen. Daartoe wordt ook beschreven welke ontwikkelingen er zijn in de manieren waarop burgers toegang tot recht in praktijk (proberen te) realiseren. Het doel is inzicht te krijgen in de betekenis van toegang tot recht en ‘de staat van’ toegang tot recht in Nederland. De paper heeft de volgende structuur. Hij vangt aan met een verkenning van wetenschappelijke literatuur over de betekenis en het belang van toegang tot recht als ideaal in een moderne rechtsstaat. Dan een beschrijving van de juridische achtergrond en de ontwikkelingen in beleid. Er lijkt grote consensus over de wenselijkheid van toegankelijkheid van het recht voor burgers in algemene zin, maar er zijn recent veel wettelijke en beleidsmatige veranderingen doorgevoerd die invloed hebben op de toegankelijkheid van het recht. Ten slotte volgen enkele kritische kanttekeningen bij ontwikkelingen die deze toegankelijkheid beperken. Er zitten risico’s aan de huidige nadruk op (juridische) zelfredzaamheid van burgers in een complexe samenleving met zoveel regeldrukte als de onze.
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