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This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States.

Integrated care is a global reform principle for improving patient access and outcomes by ensuring that healthcare organisations deliver services in a joined-up, person-centred way. Following reforms designed to infuse agency within English National Health Service (NHS) organisations, the agenda for integration must come to grips with the different approaches to joint working that these organisations mobilise, and the compatibility of their different agentic orientations. We build a matrix for identifying the extent to which different forms of agency orient nine NHS organisational types. Interrogating the Strategic and Operational Plans of these organisations for the period 2015–2018 based on questions derived from the matrix, we associate each organisation with one of eight generalised models. Assuming that there is greater potential for integration where organisations mobilise similar forms of agency, we discuss the incentives and potential governance changes that policy makers might consider to enhance integrative potential.

© 2017 University of Durham and John Wiley & Sons, Ltd Countries adopt different methods and processes to evaluate the benefits and costs of health technologies. It is important to identify and analyse the factors that influence the uptake and use of these methods and processes across countries. In this article, we introduce a regulatory governance approach to the analysis of convergence, divergence and hybridity in Health Technology Assessment (HTA) methods, discussing and critically analysing national processes for HTA in two major EU member states: England and Germany. We argue that any reasonably sophisticated account of national approaches to HTA must recognise that globalisation and the emergence of advanced industrial society involves the potential for widely varying processes, methods and evidential requirements. We suggest that this potential also confronts health policy analysts with the challenge of constructing analytical frameworks capable of identifying the diverse institutional, domestic and other factors that shape national approaches to HTA.

© 2016 The Author(s). Background: Mental health disorders (MHDs) constitute a large and growing disease burden in Europe, although they typically receive less attention and research funding than other non-communicable diseases (NCDs). This study protocol describes a methodology for the mapping of MHD research in Europe as part of Mapping_NCD, a 2-year project funded by the European Commission which seeks to map European research funding and impact for five NCDs in order to identify potential gaps, overlaps, synergies and opportunities, and to develop evidence-based policies for future research. Methods: The project aims to develop a multi-focal view of the MHD research landscape across the 28 European Union Member States, plus Iceland, Norway and Switzerland, through a survey of European funding entities, analysis of research initiatives undertaken in the public, voluntary/not-for-profit and commercial sectors, and expert interviews to contextualize the gathered data. The impact of MHD research will be explored using bibliometric analyses of scientific publications, clinical guidelines and newspaper stories reporting on research initiatives. Finally, these research inputs and outputs will be considered in light of various metrics that have been proposed to inform priorities for the allocation of research funds, including burden of disease, treatment gaps and cost of illness. Discussion: Given the growing burden of MHDs, a clear and broad view of the current state of MHD research is needed to ensure that limited resources are directed to evidence-based priority areas. MHDs pose a particular challenge in mapping the research landscape due to their complex nature, high co-morbidity and varying diagnostic criteria. Undertaking such an effort across 31 countries is further challenged by differences in data collection, healthcare systems, reimbursement rates and clinical practices, as well as cultural and socioeconomic diversity. Using multiple methods to explore the spectrum of MHD research funding activity across Europe, this project aims to develop a broad, high-level perspective to inform priority setting for future research.

©2015 Taylor & Francis Neoliberalism has not simply ‘survived’; it has failed to die, seemingly outlived the socio-economic conditions that gave rise to its existence. In this way, the non-death of neoliberalism raises some important questions about the nature of ideology, principally: its relationship to socio-economic determinants, how it exercises its grip over subjects and how this grip, or hold, can itself be exorcised. Seeking insights into these questions, this paper tells the story of the scholarly response to the non-death of neoliberalism over a ten-year period of crisis: a pre-crisis era beginning with the Asian financial crisis (1997– 2007) and a post-crisis era beginning with the global financial crisis to the present day (2008–2015). The paper considers key scholarly responses to the persistence of neoliberalism at three fundamental levels: (a) the trajectory of their analytical technique, or the key concepts that underpin their wider project; (b) their critique of neoliberalism, or how these concepts render the construction of core neoliberal ideals; and (c) their ideological response to neoliberalism, or their recommendations regarding the pathway out of neoliberalism. On this basis, the paper engages in a discussion of the most plausible explanation for the non-death of neoliberalism and the most likely avenue along which the post-crisis world might build an escape.

© 2014 Elsevier Ireland Ltd. The new regulatory governance perspective has introduced several insights to the study of health technology assessment (HTA): it has broadened the scope for the analysis of HTA; it has provided a more sophisticated account of national diversity and the potential for cross-border policy learning; and, it has dissolved the distinction between HTA assessment and appraisal processes. In this paper, we undertake a qualitative study of the French process for HTA with a view to introducing a fourth insight: that the emergence and continuing function of national agencies for HTA follows a broadly evolutionary pattern in which contextual factors play an important mediating role. We demonstrate that the French process for HTA is characterised by distinctive institutions, processes and evidential requirements. Consistent with the mediating role of this divergent policy context, we argue that even initiatives for the harmonisation of national approaches to HTA are likely to meet with divergent national policy responses.

Independent regulatory agencies (IRAs) for Health Technology Assessment (HTA) are a key means by which national governments have responded to the challenge of ensuring equitable public access to a new range of medicines and treatment options within the context of limited national budgets for healthcare. In this paper, we apply a regulatory governance frame to the study of the Swedish process for HTA. Based on qualitative interviews with key institutional stakeholders, we suggest that the major challenge for Swedish IRAs for HTA is successfully communicating nationally produced research outputs to the regional authorities responsible for the delivery of health services. We conclude that a regulatory governance approach to the analysis of national processes for HTA has the capacity to draw attention to a new range of challenges and issues which have direct relevance to improving the conduct of HTA within national regulatory spaces. © 2014 Elsevier Ireland Ltd.

This article reflects on the development of Computer Assisted Qualitative Data Analysis Software (CAQDAS) briefly before describing how the software can be harnessed to aid the process of research. It shows how data from a multi-user project looking at governance in UK Foundation Trust hospitals was enhanced and made clearer through the application of a specific method of gathering and coding data using a qualitative data analysis software package: Applying searches based on word frequency counts within NVivo 8 provided an initial categorisation of topics in an efficient manner allowing for a targeted examination of the overall data. This technique has been called by us the Mustard seed approach as it starts small and builds into something bigger over time.URL: http://nbn-resolving.de/urn:nbn:de:0114-fqs130231, Este artículo reflexiona brevemente sobre el desarrollo del Software para el Análisis Cualitativo de Datos Asistido por Computadora (CAQDAS, por sus siglas en inglés) antes de describir cómo el software puede aprovecharse para ayudar el proceso de investigación. Muestra cómo los datos de un proyecto multiusuario que estudió la gobernanza en los hospitales de UK Foundation Trust se mejoraron y se hicieron más claros a través de la aplicación de un método específico de recolección y codificación de datos mediante un paquete de software para el análisis cualitativo: Aplicar búsquedas basadas en el conteo de frecuencia de palabras en NVivo 8 brindó una categorización inicial de los temas de una manera eficiente, lo que permitió un examen objetivo de los datos generales. Hemos llamado a esta técnica enfoque de la semilla de mostaza, dado que inicia pequeño y se construye algo más grande con el tiempo.URL: http://nbn-resolving.de/urn:nbn:de:0114-fqs130231, In diesem Beitrag wird zunächst kurz der aktuelle Entwicklungsstand computergestützter qualitativer Datenanalysesoftware reflektiert, um dann zu beschreiben, wie Software als Hilfsmittel im Forschungsprozess genutzt werden kann. Es wird gezeigt, wie die Datenlage aus einem Projekt, das sich mit der Führung britischer Foundation-Trust-Krankenhäusern beschäftigt hat, durch die Verwendung eines spezifischen Verfahrens der Erhebung und Kodierung mittels Software verbessert werden konnte: Suchroutinen, die von Worthäufigkeitszählungen in NVivo 8 ausgingen, erlaubten eine initiale und effektive Kategorisierung von Themen, deren Ergebnisse dann für die gezielte Prüfung aller Daten zum Einsatz kamen. Wir haben dieses Verfahren "Senfkorn"-Ansatz genannt, da es im Kleinen beginnt und sich sukzessive ausweitet.URL: http://nbn-resolving.de/urn:nbn:de:0114-fqs130231

There are no automatic links between the functional advantages and pressures associated with delegation to independent agencies for Health Technology Assessment (HTA) and their emergence in national regulatory spaces. We argue that the rise of these organizations is mediated by contextual factors, which must be explained. Accordingly, we analyze the German 'regulatory space' for health policy decision-making, identifying contextual factors relevant to the adoption of the Efficiency Frontier approach. Based on qualitative interviews with key stakeholders, we argue that the development of the Efficiency Frontier can be associated with cultural reluctance to frame healthcare prioritization decisions around cost based valuations of human health and related doubts about the validity of metrics for human health gain. Based on this finding, we conclude that the delegation of authority to independent HTA agencies follows a broadly evolutionary pattern, in which contextual factors allow for significant variation in institutional and methodological responses to the functional pressures and advantages leading to their establishment. © 2013 Elsevier Ireland Ltd.

Today, policy analysts and regulatory governance scholars are sceptical about the capacity of the regulatory state hypothesis to describe change at the institutional level. For many, the hypothesis is a convenient oversimplification that fails to account for the hybridity of institutional arrangements within individual policy sectors and also for the divergence of reform trajectories across different national and sector-based policy contexts. This article assesses the influence of the key themes of the regulatory state on the UK Labour government's reregulation of National Health Service (NHS) commissioning organizations. Following the critics, it argues that these themes are only partially evident in the programme. While the government has codified previously informal relationships with policies like Patient Choice and has also subjected commissioning organizations to metaregulatory techniques, its reforms have neither displaced public ownership and the direct supply of commissioning services with markets and new mechanisms for rule making and standard setting, nor have the reforms divided labour within the state by creating an independent agency to regulate NHS commissioning organizations via technocratic means. Under the reforms, NHS commissioning continues to take place within a structure of bureaucratic relationships. However, the article suggests that the hybridity of regulatory techniques at work within the UK Labour government's reregulation of NHS commissioning lends weight to the claim that the current era is one of regulatory capitalism. It concludes with a discussion of the consequences of this finding for the public policy and regulatory governance literatures. © 2010 The Author. Law & Policy © 2010 The University of Denver/Colorado Seminary.