Mapping research activity on mental health disorders in Europe: study protocol for the Mapping_NCD project.

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.

Challenges to sovereign ambitions: forces of convergence and divergence within the global pharmaceutical sector and the UK's withdrawal from the European Union.

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.

European Non-Communicable Respiratory Disease Research, 2002-13: Bibliometric Study of Outputs and Funding.

This study was conducted in order to map European research in chronic respiratory diseases (CRDs). It was intended to assist the European Commission and other research funders to identify gaps and overlaps in their portfolios, and to suggest ways in which they could improve the effectiveness of their support and increase the impact of the research on patient care and on the reduction of the incidence of the CRDs. Articles and reviews were identified in the Web of Science on research in six non-communicable respiratory diseases that were published in 2002-13 from 31 European countries. They represented only 0.8% of biomedical research output but these diseases accounted for 4.7% of the European disease burden, as measured by Disability-Adjusted Life Years (DALYs), so the sub-field is seriously under-researched. Europe is prominent in the sub-field and published 56% of the world total, with the UK the most productive and publishing more than France and Italy, the next two countries, combined. Asthma and Chronic Obstructive Pulmonary Disease (COPD) were the diseases with the most publications and the highest citation rates. They also received the most funding, with around two acknowledgments per paper (in 2009-13), whereas cystic fibrosis and emphysema averaged only one. Just over 37% of papers had no specific funding and depended on institutional support from universities and hospitals.

A regulatory governance perspective on health technology assessment (HTA) in France: the contextual mediation of common functional pressures.

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.

A regulatory governance perspective on Health Technology Assessment (HTA) in Sweden.

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.

Regulatory space and the contextual mediation of common functional pressures: analyzing the factors that led to the German Efficiency Frontier approach.

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.