Blockchain Papers

Federico Toth

The purpose of this chapter is to reflect on the main trajectories of change that have characterized the health systems of OECD countries in the last three decades, from the fall of the Berlin Wall to the present day. For this purpose, it is possible to identify five major "reform themes" which traveled transversally through countries generating processes of emulation and policy transfer. The five major reform themes are as follows: (1) stimulation of greater competition; (2) promotion of integration (both in terms of financing and provision); (3) decentralization; (4) strengthening the rights of the patient; (5) extension of insurance coverage. For most of these five themes it is possible to identify a reform that has acted as a forerunner, which other countries have subsequently been inspired by and followed.

F. Maino, F. Razetti

Abstract This chapter offers an in-depth look at health politics and the decentralized, tax-financed health system in Italy. It traces the development of the Italian healthcare system, including the processes leading to hospital reform and regionalization in the 1960s and 1970s and the creation of the national health service in 1978. Since the late 1980s, health policy has been shaped by the transformation of the Italian political system, further transfer of powers to the regions, and public expenditure constraints due to public debt. Policies inspired by the New Public Management approach that aimed to increase the health system’s cost-effectiveness through steps towards fiscal federalism were introduced and reversed. Over the course of the 2000s, agreements between the central state and regional governments have become the main tool for coordinating health policy and trying to settle recurring disputes regarding health expenditure responsibilities. Ongoing debates on healthcare concern measures to ensure the national health service’s sustainability, typically the control and containment of its costs, and to reduce the territorial gap and other gaps that clash with the system’s universalist design.

Karsten Vrangbæk

Abstract This chapter offers an in-depth look at health politics and the tax-financed, universal health system in Denmark. It traces the development of the Danish healthcare system, characterized by an evolving division of labor between central authorities and decentralized municipal and regional governments. Since the late 1980s, Danish health policy has seen a number of gradual changes and a major structural reform passed in 2005 that amalgamated municipalities and regions and changed healthcare financing rules, thus shifting the balance of shared power toward the center. Other healthcare issues have been cost containment, patient rights, and promotion of local integrated health services. A negotiated policy style contributes to efficient implementation of reforms once a decision has been made.

Małgorzata Gałązka-Sobotka, Iwona Kowalska‐Bobko, Krzysztof Lach, Aneta Mela · 6 authors

Introduction: The main challenge of modern hospitals is purchasing medical technologies. Hospital-based health technology assessments (HB-HTAs) are used in healthcare facilities around the world to support management boards in providing relevant technologies for patients. Aim: This study was undertaken to update the existing body of knowledge on the characteristics of HB-HTA systems/models in the selected European countries. Insights gained from this study were used to provide an optimal approach for implementing HB-HTA in Poland. Materials and methods: Firstly, we carried out a systematic review in PubMed and embase. Secondly, we searched for gray literature via the AdHopHTA online handbook and the design book of the AdHopHTA project, as well as literature describing healthcare systems provided by the WHO. Then, we conducted in-depth interviews with HB-HTA experts from four countries. Finally, we selected ten countries from Europe and prepared frameworks for data collection and analyses. Results: The selected countries (Switzerland, Spain, France, Italy, Denmark, Finland, Sweden, the Netherlands, and Austria) are examples of decentralized or deconcentrated healthcare systems. In terms of HB-HTA, differences in organisational models (independent group, stand-alone, integrated-essential, integrated-specialised), type of financing (internally vs. externally), collaboration with an HTA National Agency and other stakeholders (e.g., Patients’ Associations) were identified. HB-HTA engages multi-skilled staff with various academic backgrounds and operates mainly on a voluntary basis. Conclusion: Strengths and weaknesses associated with various organisational models must be carefully considered in the context of support for decentralized or centralized models of implementation while embarking on HTA activities in Polish hospitals.

Eline Aas, Tor Iversen, Oddvar Kaarbøe

Abstract The Norwegian health care system is semi-decentralized. Primary care and long-term care (LTC) are the responsibilities of the municipalities. Specialist care is the responsibility of the central government and is organised through four Regional Health Authorities (RHA). Resource use, health outcomes and severity are the three main pillars for priority setting, regularly applied in reimbursement decisions for pharmaceuticals. The sustainability of health care is challenged in Norway. The main factors are a growing elderly population with high need of complex, coordinated services, an increasing demand for newly approved drugs and advanced technology and a potential shortage of health care personnel. We present recent trials and policy reforms in Norway aimed at improving care pathways combined with cost containment. Reforms in the pharmaceutical market, both with regard to market access and reimbursement (cost-effectiveness), and regulation of prices, have resulted in cost containment. The primary care sector awaits reform initiatives to recruit and retain physicians as general practitioners. No reform in the hospital sector has had cost containment as a main focus. The sector is characterized with low productivity growth, and expenditures that have increased more than the GDP growth. Waiting times are long, and coordination between sub-sectors of health care has been poor, although the Coordination reform of 2012 has alleviated some of the challenges related to intersectoral coordination. Still, the divided responsibility for health care between the central government and the municipalities creates tensions between national ambitions and local decisions in the financing and provision of health services.

Noemia Liege Maria da Cunha Bernardo, Luciano Soares, Silvana Nair Leite

The decentralization of the Brazilian health system required that municipalities took responsibility for the local Pharmaceutical Policy and Services (PPS) system. This article presents and analyses an innovative experience of diagnosis of municipal PPS as a sociotechnical system. We adopted a multi-methods approach and various data sources. Sociotechnical theory was the framework of the methodology of evaluation and design of systems, analyzing the External System (health system, stakeholders, financing) and Internal System (goals, management, workforce, infrastructure, processes, technology and culture). The "objective" component of the PPS system was identified as the central element. The lack of a unified objective and of a central coordination and unmanaged pharmaceutical services prevented integrated internal planning and planning with other sectors. Stakeholders and documents referred only to technical elements of the system: Infrastructure, technical process, and technology. The social components of the workforce and culture were not mentioned. The organizational culture established was the culture of isolation: "Each one does his own". The pharmacists working in the municipal health system did not know each other. There was no integration strategy between pharmacists and their work processes. Consequently, the municipal PPS had limited scope as a public policy. It had constrained the characteristics of PPS as a complex and open system. Understanding the municipal PPS as a sociotechnical system can push the development of a new level of policy and practice to ensure the population's right to the access to and rational use of medicines.

Niraj Vyas

<p class="abstract">Drug development is a complex and resource intensive endeavor. The average cost of developing a new drug, has been estimated to be $2 to $3 billion. However, the success rate of clinical trials is very low around and is estimated to be between 3-5%. The common reasons for failure of clinical trials include failure to demonstrate efficacy or safety, budgeting and financing, failure of subjects meeting protocol eligibility criteria, poor investigator site selection, patient withdrawals and dropouts. Considering the growing demands to get better and affordable treatment options, there needs to be fundamental shift required in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonisation in the E6 R2 addendumhas now provided guidelines for adaptation of risk based approach to trial conduct and monitoring to implement mitigation strategies for potential risks which might derail the conduct of the trail. The industry is steadily gearing up to put together the required processes, systems and teams to align to the new ways of working. However with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, esource, electronic health record/electronic medical records interoperability, implementation of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now. This paper explores the impact of these new developments on the future of risk based monitoring in clinical trials.</p>

M. Leitner, Daniel Buschmann, Tiago Capela Lourenço, I. Coninx · 5 authors

“Our house is on fire”, climate activist Greta Thunberg declared to the participants of the World Economic Forum in Davos in January 2020. In 2019, our house was indeed on fire. Large-scale forest fires in Australia, the Amazon, and the Arctic showed how short-term actions of disaster risk reduction and relief need to be considered along with long-term measures of climate change adaptation. Climate-induced extreme weather events are currently increasing and intensifying, thereby leading to new forms of disaster risk. In order to sustainably extinguish this metaphorical fire, separated strategies are no longer enough. Responding to short term climate risks without considering the long-term climate trends, and vice-versa, is no longer an acceptable course of action, as it separates (knowledge and financial) resources that should belong together. However, integrated approaches to DRR and CCA can provide opportunities for building resilience. By collecting the hands-on experience from twenty-eight CCA and DRR experts across Europe, this guidance addresses the challenges and positive results from such integrated approaches in order to synthesise actionable policy advice for institutional actors across various governance levels.We provide twenty recommendations in five areas: 1) safeguarding sound governance, 2) ensuring effective financing, 3) seizing opportunities for cooperation, 4) sharing new forms of communication, and 5) enhancing knowledge management.Each recommendation (for details, see Annex 7.2) was developed with the aim to:•Formulate a precise advice of what needs to happen.•Introduce the relevance and limitations of the chosen approach.•Showcase a possible way forward to apply such approach.•Explain which institutions are addressed and how they can benefit.•Provide an example of how the recommendation can work in practice.Area 1: Safeguarding sound governanceChallenge: Separated decision-making processes and knowledge communities with different languages reduce the possibility of quickly joining resources in extreme events preparedness, when extreme events occur, and to plan for the long term when no emergency assistance is being deployed.Recommendation: Implementation of a comprehensive Climate Risk Management (CRM) approach with broad stakeholder involvement at and across different risk governance levels.New ways of including “local reasons for concern” into national policy-making are needed to implement target-oriented and ambitious adaptation and risk reduction solutions. Consequently, national governments should establish a national climate-risk council, to foster putting of CRM into action (see 4.1.1).Challenge: Separated user and stakeholder engagement processes and taxonomies applied by knowledge and policy communities creates difficulties in establishing proper research and practice communication channels, even if the target agents are common.Recommendation: Engage stakeholders at different scales that have an interest in both the decision-making process and outcomes.Robust decision-making that increases resilience to climate risks is embedded within social, economic and cultural landscapes. It is critical to engage all concerned actors in order to recognise the needs of all. Community resilience projects are good examples (see 4.1.2).Challenge: By focusing mainly on public policy and decision-making CCA and DRR communities often neglect private actors that can provide substantial contributions in case of disasters and planning for the long term.Recommendation: Develop a stronger focus on self-safeguards or individual prevention and preparedness.Successful societal implementation of adaptation to climate change and risk management requires substantial contributions by private actors. Here, public administrations lead in coordinating and paving the way. This means a need for new formats for cross-sectoral collaboration which require a strong mandate and considerable national support (see 4.1.3).Challenge: By failing to capture local knowledge in the preparedness and planning phases many CCA and DRR strategies miss out on valuable data, lessons and experiences that can enhance climate action.Recommendation: Implement integrated, participatory designed strategies and plans at the municipal level that deal with climate-induced disasters.This process relies on mobilising local knowledge and ownership, but also on sound climate data. The local scale requires an enabling environment at national level that explicitly addresses aspects of the authority of local governments to plan for and carry out essential integrated actions (see 4.1.4).Area 2: Ensuring effective financingChallenge: New funding and insuring methods are needed to address climate risks and adaptation not previously covered by classical risk sharing schemes.Recommendation: Create Sovereign Climate Insurance Funds with application of index-based insurance and Distributed Ledger Technology.Yield-based approaches to the insurance of climate-related risks (especially in agriculture) have many drawbacks such as fraud detection and risk modelling. Index-based solutions are a better option and should be worked towards. Sovereign Climate Insurance Funds can cover climate-related risks and provide financial protection and support to affected regions and small farmers (see 4.2.1).Challenge: New risk transference methods are needed to address climate risks and adaptation not previously covered by classical market-based financial debt instruments.Recommendation: Develop risk transfer and data collection via a European Risk Transfer Mechanism.EU-institutions need to provide a funding framework, highlighting international priorities in aligning CCA and DRR funding. A Distributed-Ledger-Technology-based platform with the main aim of transferring risk from Sovereign Insurance Funds to the financial market, collecting, processing and storing climate-related data, is warranted. This includes new mechanisms of debt financing, such as climate insurance and risk transfer (see 4.2.2).Challenge: Current market and policy terminologies are not fit-for-purpose for upcoming transaction of financial assets associated with climate action.Recommendation: Implement an EU Green Taxonomy with CCA and DRR components.An EU taxonomy of green projects with a combination of CCA and DDR indicators and metrics can be useful to support national initiatives in mainstreaming protection against climate change and disasters and improving the effectiveness of climate finance. The incorporation of such indicators into the EU Green Bond Standard identifies climate-proof projects and green financial instruments (see 4.2.3).Challenge: Current forecasting methods focus on what the weather ‘will be’ rather than what the weather ‘will cause’ leaving room for improvements in early warning systems and preparedness mechanisms.Recommendation: Pursue forecast-based financing to anticipate disasters and reduce human suffering and losses.Although there are funds for long-term DRR as well as for emergency response, funds for anticipatory action are still lacking. The integration of physical parameters and anticipatory weather information into applied action to reduce disaster risk, offers an opportunity for impact-oriented, forecast-based financing (see 4.2.4).Challenge: Existing financial and debt financing mechanisms in the area of CCA and DRR are still not up-to-speed with climate funding needs at local-to-national scales.Recommendation: Elaborate self-financing and crisis financing mechanisms with application of Distributed Ledger Technologies.There is a disparity between DRR and CCA finance on different levels, especially regarding the improved management of climate-related risks and resilience of the financial system to non-financial threats. National Distributed-Ledger-Technology-based platforms for accumulation of savings and climate-related crisis financing can facilitate this process (see 4.2.5).Area 3: Seizing opportunities for cooperationChallenge: Cross-country governance mechanisms for climate and disaster risk management are lacking or do not share common practices.Recommendation: Develop a strong transnational and interregional collaboration between CCA and DRR with a joint focus on current and future risks.Climate and disaster risks often become politically charged and rife with conflicts. Mainstreaming of CCA and DRR into existing or new transnational and interregional working groups on risks or geographic areas of mutual concern is a promising way to prevent such tensions from rising (see 4.3.1).Challenge: Effective communication and collaboration across CCA and DRR knowledge communities is hindered by separated taxonomies and networking mechanisms between groups of actors.Recommendation: Use Social Network Analysis for stocktaking of stakeholders and to enhance interactions.Often, particularly for cross-sectoral interaction formats, there is limited information on the reasons why actors have certain roles in their network or interact in certain ways, which can highlight obstacles to effective collaboration. Social Network Analysis helps to identify relevant stakeholders for such formats, learning about them, their network and its properties, and making use of this information to strengthen their interactions and encourage aligned resilience solutions (see 4.3.2).Challenge: Joint emergency and preparedness exercises that include both communities are lacking, which reduces learning opportunities.Recommendation: Organise joint emergency exercises to strengthen collaboration on various levels.There are many models to prepare action for climate-induced disaster risks, but the actual event may differ significantly from the modelled version. Joint emergency exercises help to explore climate risks, exchange knowledge and jointly prepare for weather anomalies. In addition, national governments need to test their early warning systems and joint disaster prevention models in reality, p

Antonio Nuzzo, Flavia Carle, Eugenio Anessi Pessina

The policies pursued both at the international and national levels have brought to the fore the concept of governance decentralization of health-care systems. In Italy, in particular, with the approval of legislative decree n. 56/2000 on fiscal federalism and the amendments to Title V of the Constitution (Const. Law n. 3/2001), the Regions have obtained wider political, administrative, organizational and management competencies also in health care. At the international level, several studies have examined the issue of equity in a decentralized health-care system. In the Italian context, this also involves the provision of essential levels of health care (LEAs) across Regions. Equity is a constitutional principle, pursued by the central level and monitored through the set of indicators of the “LEA Grid” (Griglia LEA). Starting from the “LEA Grid” indicators, through a multidimensional analysis by principal components, the study analyzes the evolution of inter-regional equity in the provision of health care (prevention, hospital care, outpatient care) between 2001 and 2012, when the process of health-care decentralization became more established. In line with the international literature, this analysis shows a significant inter-regional heterogeneity. In particular, it highlights: 1) an interregional differentiation with respect to the principal components defined “vaccination coverage”, “hospital care performance” and “outpatient care for the disabled”; 2) a persistent differentiation in “hospital care” between central-northern and southern regions; 3) a negative trend for the autonomous regions and provinces both in the provision of “hospital care” and “vaccination coverage”. The results of the study, innovative for equity dimensions explored and data available, justify the central government's intervention as guarantor of territorial equity with respect to the provision of health care.

Maria Cristina G. Bautista

No abstract is available for this record.

Lara Gautier, Abdourahmane Coulibaly, Manuela De Allegri, Valéry Ridde

For the past 15 years, several donors have promoted performance-based financing (PBF) in Africa for improving health services provision. European and African experts known as 'diffusion entrepreneurs' (DEs) assist with PBF pilot testing. In Mali, after participating in a first pilot PBF in 2012-13, the Ministry of Health and Public Hygiene included PBF in its national strategic plan. It piloted this strategy again in 2016-17. We investigated the interactions between foreign experts and domestic actors towards PBF diffusion in Mali from 2009 to 2018. Drawing on the framework on DEs (Gautier et al., 2018), we examine the characteristics of DEs acting at the global, continental and (sub)national levels; and their contribution to policy framing, emulation, experimentation and learning, across locations of PBF implementation. Using an interpretive approach, this longitudinal qualitative case study analyses data from observations (N = 5), interviews (N = 33) and policy documentation (N = 19). DEs framed PBF as the logical continuation of decentralization, contracting policies and existing policies. Policy emulation started with foreign DEs inspiring domestic actors' interest, and succeeded thanks to longstanding relationships and work together. Learning was initiated by European DEs through training sessions and study tours outside Mali, and by African DEs transferring their passion and tacit knowledge to PBF implementers. However, the short-time frame and numerous implementation gaps of the PBF pilot project led to incomplete policy learning. Despite the many pitfalls of the region-wide pilot project, policy actors in Mali decided to pursue this policy in Mali. Future research should further investigate the making of successful African DEs by foreign DEs advocating for a given policy.

Ilmo Keskimäki, Liina‐Kaisa Tynkkynen, Eeva Reissell, Meri Koivusalo · 8 authors

This analysis of the Finnish health system reviews developments in its organization and governance, financing, provision of services, health reforms and health system performance. Finland is a welfare state witha high standard of social and living conditions and a low poverty rate. Its health system has a highly decentralized administration, multiple funding sources, and three provision channels for statutory services in first-contact care: the municipal system, the national health insurance system, and occupational health care. The core health system is organized by the municipalities (i.e. local authorities) which are responsible for financing primary and specialized care. Health financing arrangements are fragmented, with municipalities, the health insurance system, employers and households all contributing substantial shares. The health system performs relatively well, as health services are fairly effective, but accessibility may be an issue due to long waiting times and relatively high levels of cost sharing. For over a decade, there has been broad agreement on the need to reform the Finnish health system, but reaching a feasible policy consensus has been challenging.

Khaled Al–Surimi

We are pleased to publish the second issue of the Global Journal on Quality and Safety in Healthcare (JQSH). In this issue, we would like to discuss the similarities and differences between research and quality improvement (QI) projects in health care. Imagine you are working in a hospital or a department within a hospital and you want to improve an aspect of health-care quality and safety by focusing on the issue of medication errors. Given that situation, you decide to implement a “zero harm” rule because of medication errors. The question is will this be a QI or a research project? In another example, you are a resident working in an oncology department and you noticed that most patients receiving certain chemotherapeutic agents had neuropathy complications, so you decided to collaborate with the physical therapist on a project to compare patients who received chemotherapy drugs and exercise with those who did not exercise. Again, the question is will this be a research project or a QI project? Regardless of the answer, it is important to implement the project systematically. If your project is focused on QI, then you should consult the QI specialists in your hospital who can help you to use the appropriate QI methodology, which includes Plan, Do, Study, Act (PDSA) cycles. If your project qualifies as research, then you should consult a research methodologist and biostatistician regarding study design, sample size, and others and work with the institutional review board (IRB) to provide guidance and templates.Many health professionals do not know how a research project differs from a QI project and when they complement each other.[1–3] Our traditional thinking is that quality and safety improvement in health care as well as the effectiveness of an intervention can only be studied in the form of a traditional scientific research project, as it has its own well-established rigorous approach. We may be ignorant or unaware of how to use the QI scientific approach to study the performance of a health-care system.[4,5] The problem lies within our frame of thinking because we are prioritizing the proof of effectiveness over bringing about and sustaining improvement. We use the results of pre-assessment and post-assessment research as the gold standard for evidence-based policy and practice, whereas in reality, sustaining the improvement is continuous and more dynamic.[1,6]Research projects are question-driven and focus on providing proof of effectiveness. The main purpose of research is to generate new generalizable knowledge about a particular subject to a study population, where the study results often end up published in academic journals. In this case, researchers must follow a strict study protocol approved by the IRB, including obtaining the consent from study participants before starting the project and report any deviation from the protocol to the IRB, if needed.[7–9] However, QI projects are data-driven and focus on showing sustained improvement to a specific process and system or outcomes within a health-care organization using, if possible, the research evidence generated as the basis for developing the improvement interventions.[10] A QI project does not aim to generate new knowledge as a research project does, rather, it generates several learning lessons as to what actually works and does not work and why. A QI project produces empirical evidence to benefit other organizations within a similar context and setting, which are interested in replicating the change to improve a process or system using the rapid PDSA cycle approach.[11] Through cycles of testing, we learn what is going to improve and why, without the need to generalize the results to another context, as research projects usually aim to do. Also in QI projects, the measurement framework is not about pre and post. It is about continually measuring the metric of interest that you want to improve and coming up with not just one intervention but multiple interventions based on learning from prior PDSA cycles. At the end, you reach the point of realizing sustained improvement through a series of interventions that were informed by testing in the actual system that you want to improve. The PDSA cycle is repeated, and new changes are made to continue to improve a process and, ultimately, the outcome. The essential measurements included in a QI project are process measures, outcomes measures, and balancing measures, which are used to show that the improvement occurs over time. Data from QI activities are usually aggregated and presented in run/control charts, histograms, and line graphs, whereas data from research are analyzed using statistical tests such as t-test, chi-square test, and regression analysis, and then aggregated and presented in appropriate tables and/or graphs.Typically, QI results are shared within the organization and might be implemented in other departments. The lessons learned from QI activities can be published; however, it must be clear to the readers that the project was for QI, not traditional research. Although a QI project does not require IRB approval, some organizations have QI committees that approve and coordinate QI project activities, and some organizations require articles to be approved before submitting for publication.In summary, the sustained improvement realized in a QI project can be complemented and validated with a thorough research-based assessment of effectiveness.[12] We should not consider the proof of effectiveness the same as the proof of sustained improvement, but they both are very important. I would like to emphasize that both research and QI projects use scientific and systematic approaches, albeit different, but both methods are scientific and rigorous in their own ways. The aims, methods, and outcomes in research and QI projects are quite different. Hence, understanding the differences and similarities between research and QI projects will help to determine the right approach when designing and implementing the right project for the right purpose using the right method. Table 1 is a snapshot comparison between QI and research with more focus on the project's aim and method aspects.In research projects, we can be guided by asking the following: Do we have a clear question to be investigated and answered?What do we hope to accomplish by answering the question?What is currently known about the topic?What are the risks and benefits for patients involved with the study of this topic?What type of study design will be used (observational vs. experimental)?How will the data be analyzed and presented (statistical tests, P-values, etc.)?In QI projects, we can ask the following: What is the magnitude of the quality problem based on available data?What types of quality tools have been used to measure and assess the problem?What is the measurement plan to be used during implementation of the project?What types of changes/interventions will be tested during the PDSA cycles?Has the proposed change/intervention been used in other health-care settings or reported in the literature?Will the results of this project directly improve patient-care outcomes or processes?Is the organization's management supportive of the project and willing to dedicate employee's time and supplies to do the project?What is the sustainability plan for the results?

Domenico De Matteis, Alessio Ishizaka, Giuliano Resce

No abstract is available for this record.

Angelita Kithatu-Kiwekete

The rationale for central government to devolve resources for service provision has been debated in decentralization literature. Decentralization enhances democracy, encourages participation in local development initiatives and promotes local political accountability. This discourse has been complemented by the implementation of fiscal decentralization to increase the ability of sub-national government in financing municipal service delivery. Fiscal decentralization has often been adopted by African states since the onset of the New Public Management era in an effort to improve the standard of governance. The concern is that African states have taken minimal steps to adopt fiscal devolution that promotes revenue assignment which in turn limits sub-national governments’ ability to generate own source revenues. This article examines the revenue assignment function of fiscal decentralization in the Democratic Republic of Congo (DRC) in the light of decentralization concerns that have been raised by civil society, as the country charts its course to democracy. The article is a desktop study that will consider documents and policies in the DRC on the national, provincial and local level as far as state revenue sources are concerned. Revenue assignment should enable DRC’s provinces and local authorities to generate significant revenue independently. However, post-conflict reconstruction and development efforts in the Great Lakes region and in the DRC have largely isolated decentralization which would otherwise entrench local fiscal autonomy in financing for local services and development. The article concludes that revenue generation for local authorities and the provinces in the DRC is still very centralised by the national government. The article proposes policy recommendations that will be useful for the country to ensure that decentralization efforts include fiscal devolution to enhance the financing for local development initiatives.

Ademar Arthur Chioro dos Reis, Ana Paula Menezes Sóter, Lumena Almeida Castro Furtado, Silvana Souza da Silva Pereira

Decentralization and regionalization are strategic themes for reforms in the health system. This paper analyzes the complex process of health regionalization being developed in Brazil. This paper identifies that the normative framework from the Brazilian National Health System, SUS has made advances with respect to its institutionalization and overcoming the initial centrality involved in municipalization. This has strengthened the development of regionalization and the intergovernmental agreement on health but the evidence points to the need to promote a revision. Based on document analysis, literature review and the views given by the authors involved in management in SUS as well as generating radically different views, the challenges for the construction of a regionalization that is active, is debated. We also discuss: its relations with planning and the dimensioning of service networks, the production of active care networks and shared management spaces, the inter-federative agreements and regional regulations, the capacity to coordinate regional systems and financing and the impact of the political dimension and electoral cycles. Regionalization (and SUS itself) is an open book, therefore ways and possibilities on how to maintain an active form of regionalization can be recommended.

Vladimir Gužvić, Tarik Čatić, Marina Kostić

OBJECTIVES: The aim of this study was to describe the healthcare system and health financing in Bosnia and Herzegovina and recent trends in health technology assessment (HTA) placement in the system. METHODS: A short review of PubMed published literature has been conducted using key words related to reimbursement, HTA, and health policy. We also revised legislation in Bosnia and Herzegovina published in Official Gazettes related to healthcare financing and organization. RESULTS: A deecentralized system in Bosnia and Herzegovina led to high differences in health policy. HTA has been recognized in legislation in Bosnia and Herzegovina, but it still has not been introduced in practice in full capacity. A small number of publications are found in PubMed treating these issues, but generally the problem of introduction of HTA in Bosnia and Herzegovina is lack of experts, as well as the political environment and education in this field. CONCLUSIONS: HTA in the Federation of Bosnia and Herzegovina and the Republic of Srpska has a short history because of a huge political impact in the decision-making process, decentralized system, and multiple decision makers in these regions. Challenges remain in assessments, in development of more transparent approaches in different areas of the health system in these regions, and in consistent application of appropriate standards especially in education of professionals who will provide establishment of HTA in the health system of The Federation of Bosnia and Herzegovina and the Republic of Srpska.

Banque Interaméricaine de Développement, Banco Interamericano de Desenvolvimento

This Breve is based on the original thesis work and on a webinar presented by Dr. Fábio Ferride-Barros regarding the "Ethics of Health Resources Allocation in the Publicly Financed Health Care System in Brazil." The perspective offered in this Breve complements a previously published issue documenting the use of health technology evaluation in decision-making in Brazil's health sector (IDB, 2015). The Breve introduces the challenges of priority setting in the context of a large and decentralized national universal health care system, which confronts resource scarcity and substantial inequalities.

Carl F. Cranor, Adam M. Finkel

Abstract Regulatory agencies in the United States and Europe have well‐deserved reputations for fixating on the total benefits and costs of proposed and final regulatory actions, without doing any more than anecdotally mentioning the subpopulations and individuals who may bear disproportionate costs or reap disproportionate benefits. This is especially true on the “cost” side of the cost–benefit ledger, where analysts exert little effort to even inform decisionmakers and the public that the costs of regulations might be distributed either regressively or progressively. Many scholars and advocates have observed that regulation can increase the efficiency of market outcomes, but caution about its untoward (or suboptimal) effects on equity. Here, we argue that without considering distributional information about costs and benefits, regulatory policies in fact can also cause violence to notions of efficiency , for two reasons: (i) society cannot hope to approach Pareto‐efficient outcomes without identifying those who must lose so that others can gain more; and (ii) because the harm experienced by involuntary risks and by imposed regulatory costs is likely non‐linear in its magnitude (at the individual level), efficiency is, in fact, a strong function of the shape of the distribution of these effects. This article reviews evidence about the distribution of regulatory costs and benefits, describes how agencies fail to incorporate readily available distributional information, and sketches a vision for how they could analyze costs and benefits to promote more efficient regulatory choices and outcomes.

T Catic

No abstract is available for this record.

Kurt Samson

FigureA group of leading lymphoma researchers have issued a list of priorities to improve the current research paradigm and identify future investigational needs. In a Letter to the Editor in Blood (2015;125:2175-2177), David M. Weinstock, MD, Associate Professor at Harvard Medical School and an attending physician in the Medical Oncology Service at Dana-Farber Cancer Institute, and 11 other lymphoma experts, outline a plan to better address current shortcomings in research approaches and what can be done to improve investigations and collaborations. The recommendations are the result of a collaborative initiative by the American Society of Hematology, which started the project during a forum on basic and translational science relevant to lymphoma that began at the first ASH Meeting on Lymphoma Biology, held last August. The authors of the letter, members of the meeting's steering committee, were asked to create a research “roadmap” for future efforts in order to better guide funding, especially requests from the National Institutes of Health, as well as advocacy by ASH and other associated organizations. “Our goal is to help inform future research directions and funding decisions by partners at government agencies and in the private sector,” said Weinstock, Co-chair of the ASH initiative. Although almost half of all blood cancer cases are lymphomas, of which there are numerous unique disease subtypes, recent advances have led to better characterization on how lymphoma cells proliferate and interact with other cells and tissues, leading to powerful, targeted therapies with fewer side effects than approaches in the past.DAVID M. WEINSTOCK, MD. DAVID M. WEINSTOCK, MD: “The roadmap outlines our most pressing needs, that if not addressed will stand in the way of transformative changes in how we study and treat lymphomas.Nonetheless, limitations in research infrastructure, funding, and collaborative approaches present potential challenges in the development of better treatments. The report outlines key priorities for research and infrastructure to improve the understanding of lymphoma biology across its diverse subtypes (see box on next page). “The roadmap outlines our most pressing needs, that if not addressed will stand in the way of transformative changes in how we study and treat lymphomas,” Weinstock said. “We want to help facilitate and guide collaborative efforts toward the most high-impact areas that might lead to more rapid development of new treatments.” According to the panel, investigation of individual lymphoma subtypes is largely limited by many of the same issues with other tumors, including inadequate numbers of representative cell lines and in vivo models, including patient-derived xenografts and genetically engineered mouse models; inadequate characterization of the genetic, epigenetic, transcriptional, proteomic, and metabolomic landscape of each subtype; limited interest from the pharmaceutical industry in rare subtypes with poorly understood pathobiology; and insufficient collaboration across centers. These shortcomings are made more complicated by biologic heterogeneity within each lymphoma subtype, and preclinical studies addressing this heterogeneity will require large numbers of samples and/or models for stratifying patients and validating potential biomarkers, according to the letter. Addressing Barriers “So far the response has been somewhat muted,” Weinstock said. “We are inviting clinicians, scientists, advocates, and patients to weigh in on this so that it reflects the input of everyone in the community.” The panel will share its findings on priorities with funding agencies, advocacy groups, and others who can help address the challenges identified. Weinstock said that because of the current lack of a coordinated research approach, many lymphoma patients have poor outcomes, including those with mantle cell lymphoma, subtypes of peripheral T-cell lymphoma, and lymphomas that harbor specific genetic markers. Moreover, the consequences of most genetic mutations remain unclear, making it necessary to develop functional approaches to distinguish driver events and more clearly define critical dependencies that can be exploited therapeutically. “The most important priority is to develop model cell lines in vivo and cell lines in lesser and more common subtypes,” he said. Another high priority is developing new prognostic models that incorporate biologically informative predictive factors along with clinical factors to enable patient selection for clinical trials and highlight the biological pathways and mechanisms that can influence therapeutic response. “Comprehensive investigations of larger collections of clinically annotated patient samples are needed to identify additional determinants of treatment response, and these predictive features will inevitably shift with new therapies,” he said. “A lot of this research is now being done at academic centers, but because they rely on outside funding there are proprietary reasons to protect their findings—so many institutions are research silos. Once findings are published, much of the data is available to the oncology community, and most cell lines are already in circulation. This is a significant challenge and a major roadblock.” ‘Difficult to Get Everyone on the Same Page’ There is some skepticism that this will change any time soon, Weinstock admitted. “It is difficult to get everyone on the same page. With some subtypes there are fewer than 1,000 patients, so this is not just hysteria.” “There have been efforts like this before, but this is the most comprehensive. Targeted immunotherapy has shown promise against some lymphomas and others are being tried. I can almost see the endgame.” ‘A First Step’ Asked for his perspective, Jason Westin, MD, Assistant Professor in the Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center, said: “I think this is an important first step in getting the lay of the land. Without a consensus it is very difficult to get down to the bare bones of what needs to be done to get big data for cooperative studies.” Westin has been involved in research on diffuse large B-cell lymphoma; development of systems to identify novel, optimal therapeutic combinations for individual patients, as well as drug synergy, additivity, and antagonism, scale free networks and their role in cancer therapy; and development of highly sensitive disease monitoring methods. In an article titled “Busting Robustness: Using Cancer's Greatest Strength to Our Advantage,” published in January in Future Oncology (2015;11:73-77), Westin posed the question of what complex networks, such cancer cells, airplane flight patterns, and the Internet share in common. The answer? All have both remarkable robustness and great vulnerability. “Complex networks follow remarkably similar patterns across seemingly unconnected fields, and it is possible that cancer researchers could thus learn from the advances in complex network theory,” he wrote, noting that very limited but coordinated specific targeting of the most critical parts of such networks can have dramatically outsized effects.”JASON WESTIN, MD. JASON WESTIN, MD: “Developing a coordinated and systematic approach is very difficult—but the more we cooperate, the more we understand how to do it.”He said that developing a coordinated and systematic approach is very difficult—“but the more we cooperate, the more we understand how to do it. All of the authors of this plan are really leading researchers in lymphomas, but the proof is in the projects that may result.” He said that creating central repositories of tissues and cells in patients who do well or not is especially important for future research because most studies undertaken have relatively small sample sizes. “Sharing this data and samples in an open-format central repository would be huge,” especially because of the increasing robustness of data from tissue samples fixed in formalin. Even so, Westin continued, it will take some effort to build this due to potential resistance from individual research groups at institutions with a stake in protecting their findings until publication. “This is one main stumbling block as I see it, but it could be done if such data, especially genomic information about patients, were somehow protected.” There are a number of good precedents for such an approach, especially the Cancer Genome Atlas at NIH, he noted: “I would really like to change this. I am not sure it will happen tomorrow, but the more we try, the more value will become apparent. This roadmap lays the groundwork and it may take years, but ultimately it is the patients who will benefit.” Priorities The plan identifies the following priorities in infrastructure and research: Infrastructure Develop an adequate number of disease models for each lymphoma subtype; Establish a central repository of biospecimens, cell lines, and in vivo models with open access; and Organize patient advocacy to support research. Research Catalog how lymphoma cells differ across disease subtypes; Better define and identify mutations and other abnormalities associated with the disease; Develop strategies to identify high-risk patients who may benefit most from clinical trials; Enhance efforts to use immune therapies to cure lymphoma; and Better understand how lymphoma cells communicate with normal cells. From Weinstock et al: Blood 2015;125 (13):2175-2177 Coauthors The other coauthors of the Roadmap letter in Blood are: Riccardo Dalla-Favera, Randy D. Gascoyne, John P. Leonard, Ronald Levy, Izidore S. Lossos, Ari M. Melnick, Grzegorz S. Nowakowski, Oliver W. Press, Kerry J. Savage, Margaret A. Shipp, and Louis M. Staudt.

Sabina Nuti, Federico Vola, Anna Bonini, Milena Vainieri

The Italian Health care System provides universal coverage for comprehensive health services and is mainly financed through general taxation. Since the early 1990s, a strong decentralization policy has been adopted in Italy and the state has gradually ceded its jurisdiction to regional governments, of which there are twenty. These regions now have political, administrative, fiscal and organizational responsibility for the provision of health care. This paper examines the different governance models that the regions have adopted and investigates the performance evaluation systems (PESs) associated with them, focusing on the experience of a network of ten regional governments that share the same PES. The article draws on the wide range of governance models and PESs in order to design a natural experiment. Through an analysis of 14 indicators measured in 2007 and in 2012 for all the regions, the study examines how different performance evaluation models are associated with different health care performances and whether the network-shared PES has made any difference to the results achieved by the regions involved. The initial results support the idea that systematic benchmarking and public disclosure of data are powerful tools to guarantee the balanced and sustained improvement of the health care systems, but only if they are integrated with the regional governance mechanisms.

Gregory P. Marchildon

No abstract is available for this record.

Sorin Dan

This thesis asks whether the increased autonomy and decentralization associated with the New Public Management (NPM) have impacted on the coordination of organizations within the public sector. Ideas and practices once typical of the private sector have become increasingly common in public sectors around the world. Often times they have been promoted under the umbrella of fashionable terms such as rdquo;, “modernization” or New Public Management (NPM). Although not entirely new, these ideas gained momentum, starting in the early 1980s, in some Western democracies and then increasingly became promoted as a solution – and sometimes the solution nbsp;to public administration problems across the world. Great variation exists, however, in their spread and implementation across countries and sectors. Two of these proposals for change are the disaggregation of bureaucratic forms of organization and decentralization. The expectation has been that these reforms would improve operational flexibility, responsiveness to the needs of service users and ultimately quality and performance. Following these reform proposals, administrators are supposed to make use of greater discretion in the application of managerial principles and techniques. Managers and the entities they lead are expected to exercise initiative, to be proactive, and to act rather than just to react to imperatives from politicians, as it was traditionally common in public administration. A second major reform that has been widely experimented with in the public sector is decentralization. Decisions, it is argued, ought to be made as close to the citizen as possible. In this way it is assumed that information and understanding of local needs improve, which can further translate into better decision making. There is also an ambition to reduce the overload and delay associated with highly centralized decisions. However, the trend towards decentralization is neither new nor uniform across public sectors. Some governments have taken steps to recentralize certain functions after earlier efforts to decentralize while others have been initially reluctant to decentralize, but recently have taken more confident steps in this direction. The specific setting of this doctoral dissertation comprises public hospital systems in selected European countries: 1)nbsp; a Nordic country – Norway 2)nbsp; nbsp;Baltic, EU member state since 2003, formerly part of the Soviet Union – Estonia 3) a nation in Central and Eastern Europe (CEE), a former communist state and an EU member state since 2007 – Romania. The thesis comprises eight chapters. Chapter 1 introduces the subject matter and motivates its academic and social relevance. Chapter 2 reviews the literature and shows how the subject matter of the thesis is embedded in the broad academic discourse. This consists of the public administration and management literature – particularly New Public Management, governance and coordination – on the one hand, and healthcare and hospital management and governance, on the other hand. It provides a theoretical review of the concept of coordination, and shows how different theories have dealt with coordination in a public sector context. The chapter also reviews existing analytical and empirical approaches to coordination. In chapter 3 we propose an analytical framework geared to the central coordination of publicly-owned hospitals. The framework builds on two theories – principal-agent theory and sociological institutionalism – and seeks to explain why coordination problems occur across the three cases. Chapter 4 includes the research design: the case selection and methods. The thesis uses an explanatory comparative case study approach to understand how reform affects coordination in hospital systems in the three country cases: Estonia, Norway and Romania. We use congruence analysis as a specific type of case study research. Congruence analysis connects empirical observations to expectations derived from theory. The main source of empirical material comprises of a program of semi-structured interviews conducted in all three countries with various stakeholders – both in central institutions and public hospitals. This evidence is supplemented with relevant documentary data and statistical information. Chapters 5 through 7 constitute the core of the thesis and they describe, evaluate and explain the relationship between organizational reform in public hospitals and coordination problems. Each of these three country chapters ends by discussing the compatibility between empirical findings and the theoretical propositions derived from the two theories. In each country chapter we seek to explain the relationship between organizational reform in public hospitals and central coordination by means of the theoretical framework introduced in Chapter 3. Chapter 8 concludes by comparing the empirical and theoretical findings across the three cases and discusses the implications of the results for theory and practice. The research has reached the following conclusions: nbsp; Organizational reform in public hospitals has constituted an important component of healthcare policy in all three countries in the past 10 to 15 years. All three countries have experimented with structural reform (including decentralization or centralization) and have grappled with granting management autonomy to public hospitals while seeking to solidify policy-making and coordination capacity at the center of government nbsp; This administrative change across the three hospital systems has not been marginal only – it has involved major resources and has received considerable attention from different stakeholders •nbsp; Although hospital decentralization and autonomy reform constitute on-going processes that may constantly undergo some degree of change, we have observed that in two of our three cases, Estonia and Norway, the reform model proposed more than 10 years ago has essentially endured to the present. While ideas for change to the model have been put forward, in Norway for example, it is unlikely that this change would radically reshape the type of reform model adopted years ago. Romania, while clearly experimenting with the same types of international ideas, has thus far only implemented decentralization. Granting greater autonomy to hospital management is still an idea that is being considered by central policy makers in Romania, but it is uncertain if, when and how it will be implemented nbsp; In the face of organizational reform the state capacity to coordinate the decentralized and autonomous hospitals has been put to the test nbsp; We have observed a reconsideration of the role of central institutions, most notably the ministries of health, but also health insurance funds in social insurance systems or other central bodies in tax-based systems nbsp; Hospital autonomy has overall posed serious challenges to the central coordination of autonomous hospitals in Estonia, much more so than in the case of Norway and Romania nbsp; However, the autonomy of hospitals is not the only factor that affects the effectiveness of coordination. Hospitals that enjoy a lower degree of autonomy, as in Romania for example, are not necessarily more effectively coordinated than hospitals that enjoy a high degree of decision-making discretion nbsp; nbsp;Norway, a high-trust society that is compliant with government regulation, coordination problems exist in more specific areas of ICT and in the case of elite medical specialties in the Oslo University Hospital. Overall, coordination in Norway has significantly improved following the 2002 hospital reform, but this does not necessarily mean that coordination in the public hospital sector is problem-free nbsp; Hospital system culture and principal-agent theory offer complementary insights into the dynamics of public hospital coordination. Conflicting interests and goals and cultural factors are particularly relevant in understanding the effectiveness of central coordination of public hospitals nbsp; There is more evidence for some propositions of principal-agent theory than for othersnbsp;more evidence was found in favour of conflicting interests and goals than in the case of imperfect information. Positive and negative incentives are situated in the middle with more evidence in some cases than in others. The thesis contributes to the existing literature in the following ways: nbsp; Directly compares two eastern and one western European system and shows that such comparison, although it does not follow a most similar research design, is both feasible and productive. This research finds that problems of coordination can occur in different systems and therefore to study public sector coordination comparatively one can choose to select cases that display differences between them and look for factors that can explain a similar outcome nbsp; Covers one country where only very limited research on hospital reforms has previously been published (Romania) •nbsp; Sets out new primary evidence in the form of original interviews and documentary evidence which has not previously been cited in academic research nbsp; Employs two theoretical approaches in a comparative and complementary way, and argues that conflicting interests and goals and hospital system culture help explain coordination in European public hospital systems nbsp; Proposes an analytical framework for analyzing coordination in public hospital systems and finds the framework to be useful in that it encourages researchers and practitioners to think specifically about the implications of coordination; that is, the problems and effects of coordination problems.