The cost of clinical negligence claims continues to rise, despite efforts to reduce this now ageing burden to the National Health Service (NHS) in England. From a welfarist perspective, reforms are needed to reduce avoidable harm to patients and to settle claims fairly for both claimants and society. Uncertainty in the estimation of quanta of damages, better known as financial settlements, is an important yet poorly characterised driver of societal outcomes. This reflects wider limitations to evidence informing clinical negligence policy, which has been discussed in recent literature. There is an acute need for practicable, evidence-based solutions that address clinical negligence issues, and these should complement long-standing efforts to improve patient safety. Using 15 claim cases from one NHS Trust between 2004 and 2016, the quality of evidence informing claims was appraised using methods from evidence-based medicine. Most of the evidence informing clinical negligence claims was found to be the lowest quality possible (expert opinion). The extent to which the quality of evidence represents a normative deviance from scientific standards is discussed. To address concerns about the level of uncertainty involved in deriving quanta, we provide five recommendations for medico-legal stakeholders that are designed to reduce avoidable bias and correct potential market failures.

Canada's experience with the coronavirus disease-2019 (COVID-19) pandemic has been characterized by considerable regional variation, as would be expected in a highly decentralized federation. Yet, the country has been beset by challenges, similar to many of those documented in the severe acute respiratory syndrome outbreak of 2003. Despite a high degree of pandemic preparedness, the relative success with flattening the curve during the first wave of the pandemic was not matched in much of Canada during the second wave. This paper critically reviews Canada's response to the COVID-19 pandemic with a focus on the role of the federal government in this public health emergency, considering areas within its jurisdiction (international borders), areas where an increased federal role may be warranted (long-term care), as well as its technical role in terms of generating evidence and supporting public health surveillance, and its convening role to support collaboration across the country. This accounting of the first 12 months of the pandemic highlights opportunities for a strengthened federal role in the short term, and some important lessons to be applied in preparing for future pandemics.

In Ireland, the coronavirus disease 2019 (COVID-19) pandemic has led to a total of 230,599 cases of infection as on 20 March 2021, and 4323 deaths. Although the Irish hospital network has not been overwhelmed, it has faced pressures, with a total of 13,313 persons hospitalised, including 1402 admitted to the intensive care unit. Out of caution, in spring 2020, in anticipation of possible surges in hospitals in light of international experience, the Irish government reached an agreement with private hospitals to access their capacity for three months to alleviate pressure on the public system, as part of its comprehensive response to the pandemic. This piece analyses the agreement with private hospitals, based on the legally binding Heads of Terms of the agreement, which were signed by the parties, along with publicly reported details from media reports and Oireachtas (parliamentary) committee hearings. We argue that although the new relationship could, in theory, have paved the way to the nationalisation of the whole hospital system, in fact, the experiment is best interpreted as a lost opportunity to integrate and simplify Ireland's hospital system.

Research and Development (R&D) in health and health care has several intriguing characteristics which, separately and in combination, have significant implications for the ways in which it is organised, funded and managed. We review the characteristics, some of which apply under most circumstances and others of which may be context-specific, explore their implications for the organisation and management of health-related R&D, and illustrate the main features from the UK experience in the 1990s.

Step therapy, also termed fail-first policy, describes a practice of insurance and pharmacy benefit management companies denying reimbursement for a specific treatment until after other treatments have first been found ineffective (i.e. failed). Laws to limit step therapy have been passed in 29 states of the United States. Using extrapolated data on fully insured employees, we find that except for New York and New Mexico, enacted State laws don't apply to even one-third of a state's population. Using the more robust Kaiser Family Foundation (KFF) data, which do not include fully insured employees, we find that only 2–10% of a state's population is covered. Advocating for these laws has been an expensive and time-consuming process, likely to become more so for the 21 states without such laws. The laws that have been enacted can be near impossible, to enforce, and loopholes exist. As a result, using KFF data, more than 90% of people in the United States with health insurance may still be unable to access the treatment chosen as most appropriate for them with their physician. Based on these data, we conclude federal step-therapy legislation is needed.

On 31st January 2020, the Italian cabinet declared a 6-month national emergency after the detection of the first two COVID-19 positive cases in Rome, two Chinese tourists travelling from Wuhan. Between then and the total lockdown introduced on 22nd March 2020 Italy was hit by an unprecedented crisis. In addition to being the first European country to be heavily swept by the COVID-19 pandemic, Italy was the first to introduce stringent lockdown measures. The SARS-CoV-2 outbreak and related COVID-19 pandemic have been the worst public health challenge endured in recent history by Italy. Two months since the beginning of the first wave, the estimated excess deaths in Lombardy, the hardest hit region in the country, reached a peak of more than 23,000 deaths. The extraordinary pressures exerted on the Italian Servizio Sanitario Nazionale (SSN) inevitably leads to questions about its preparedness and the appropriateness and effectiveness of responses implemented at both national and regional levels. The aim of the paper is to critically review the Italian response to the COVID-19 crisis spanning from the first early acute phases of the emergency (March–May 2020) to the relative stability of the epidemiological situation just before the second outbreak in October 2020.

Aotearoa New Zealand went ‘hard’ and ‘early’ in its response to COVID-19 and has been highly successful in limiting the spread and impact of the virus. The response has ramped up over time, and has included various levels of: border control; advice on hygiene, physical distancing and mask wearing; advice to remain at home if unwell; and testing and tracing. A four-level Alert Level framework has guided key actions at different levels of risk. Strong leadership from the Prime Minister, Minister of Finance, and Director-General of Health and high levels of community co-operation have supported the response. The country is most vulnerable at its borders, where arrangements have been of concern; advice on testing and the wearing of masks has changed over time; while the use and distribution of personal protective equipment has also been of concern. The country overall was not well prepared for a pandemic, but policy-making has been nimble. Key challenges for 2021 include swiftly rolling out a vaccine, catching up on delayed health care, and deciding how and when the border can reopen. The economic, and associated social, challenges will last many years.

As of November 2020, the United States leads the world in confirmed coronavirus disease 2019 (COVID-19) cases and deaths. Over the past 10 months, the United States has experienced three peaks in new cases, with the most recent spike in November setting new records. Inaction and the lack of a scientifically informed, unified response have contributed to the sustained spread of COVID-19 in the United States. This paper describes major events and findings from the domestic response to COVID-19 from January to November 2020, including on preventing transmission, COVID-19 testing and contact tracing, ensuring sufficient physical infrastructure and healthcare workforce, paying for services, and governance. We further reflect on the public health response to-date and analyse the link between key policy decisions (e.g. closing, reopening) and COVID-19 cases in three states that are representative of the broader regions that have experienced spikes in cases. Finally, as we approach the winter months and undergo a change in national leadership, we highlight some considerations for the ongoing COVID-19 response and the broader United States healthcare system. These findings describe why the United States has failed to contain COVID-19 effectively to-date and can serve as a reference in the continued response to COVID-19 and future pandemics.

The Covid-19 pandemic has put policy systems to the test. In this paper, we unmask the institutionalized resilience of the Dutch health care system to pandemic crisis. Building on logics of crisis decision-making and on the notion of ‘tact’, we reveal how the Dutch government initially succeeded in orchestrating collective action through aligning public health purposes and installing socio-economic policies to soften societal impact. However, when the crisis evolved into a more enduring one, a more contested policy arena emerged in which decision-makers had a hard time composing and defending a united decision-making strategy. Measures have become increasingly debated on all policy levels as well as among experts, and conflicts are widely covered in the Dutch media. With the 2021 elections ahead, this means an additional test of the resilience of the Dutch socio-political and health care systems.

Patient safety is a complex systems issue. In this study, we used a scoping review of peer-reviewed literature and a case study of provincial and territorial legislation in Canada to explore the influence of mandatory reporting legislation on patient safety outcomes in hospital settings. We drew from a conceptual model that examines the components of mandatory reporting legislation that must be in place as a part of a systems governance approach to patient safety and used this model to frame our results. Our results suggest that mandatory reporting legislation across Canada is generally designed to gather information about – rather than respond to and prevent – patient safety incidents. Overall, we found limited evidence of impact of mandatory reporting legislation on patient safety outcomes. Although legislation is one lever among many to improve patient safety outcomes, there are nonetheless several considerations for patient safety legislation to assist in broader system improvement efforts in Canada and elsewhere. Legislative frameworks may be enhanced by strengthening learning systems, accountability mechanisms and patient safety culture.

Although efficiency is a core concept in health economics, its impact on health care practice still is modest. Despite an increased pressure on resource allocation, a widespread use of low-value care is identified. Nonetheless, disinvestments are rare. Why is this so? This is the key question of this paper: why are disinvestments not more prevalent and improving the efficiency of the health care system, given their sound foundation in health economics, their morally important rationale, the significant evidence for a long list of low-value care and available alternatives? Although several external barriers to disinvestments have been identified, this paper looks inside us for mental mechanisms that hamper rational assessment, implementation, use and disinvestment of health technologies. Critically identifying and assessing internal inclinations, such as cognitive biases, affective biases and imperatives, is the first step toward a more rational handling of health technologies. In order to provide accountable and efficient care we must engage in the quest against the figments of our minds; to disinvest in low-value care in order to provide high-value health care.

How do experts judge the legitimacy of technical policy processes, and do their ideas change as these processes are opened to other stakeholders and the public? This research examines the adoption of public and patient involvement in pharmaceutical assessment in Canada. It finds tensions between scientific legitimacy that prioritizes rigor and objectivity, and democratic legitimacy that values inclusion and a broader range of evidence. In response to policy change, experts incorporate new ideas about democratic inputs and processes, while maintaining scientific policy goals. The research responds to calls for more precise measurement of ideas and ideational change and more evaluation of public and patient involvement in health policy. It helps us understand the significance of, and limits to, ideational change among experts in health policy domains that are highly technical and publicly salient. Understanding the way democratic and scientific legitimacy are negotiated in policy decisions has a wide applicability in health, but is particularly relevant during a global pandemic when evidence is being generated rapidly, decisions must be made quickly, and these decisions have a significant, immediate effect on the lives of all citizens.

The coronavirus disease 2019 (COVID-19) pandemic has shifted the health policy debate in Canada. While the pre-pandemic focus of policy experts and government reports was on the question of whether to add outpatient pharmaceuticals to universal health coverage, the clustering of pandemic deaths in long-term care facilities has spurred calls for federal standards in long-term care (LTC) and its possible inclusion in universal health coverage. This has led to the probability that the federal government will attempt to expand medicare as Canadians have known it for the first time in over a half century. However, these efforts are likely to fail if the federal government relies on the shared-cost federalism that marked the earlier introduction of medicare. Two alternative pathways are suggested, one for LTC and one for pharmaceuticals, that are more likely to succeed given the state of the Canadian federation in the early 21st century.

Public reporting of clinical performance is increasingly used in many countries to improve quality and enhance accountability of the health system. The assumption is that greater transparency will stimulate improvements by clinicians in response to peer pressure, patient choice or competition. The international diffusion of public reporting might suggest greater similarity between health systems. Alternatively, national and local contexts (including health system imperatives, professional power and organisational culture) might continue to shape its form and impact, implying continued divergence. The paper considers public reporting in the USA and England through the lens of Scott's ‘pillars’ institutional framework. The USA was arguably the first country to adopt public reporting systematically in the late 1980s. England is a more recent adopter; it is now being widely adopted through the National Health Service (NHS). Drawing on qualitative data from California and England, this paper compares the behavioural and policy responses to public reporting by health system stakeholders at micro, meso and macro levels and through the intersection of ideas, interests, institutions and individuals through. The interplay between the regulative, normative and cultural-cognitive pillars helps explain the observed patterns of on-going divergence.

Singapore's health system generates similar levels of health outcomes as does Sweden's but for only 4.4% rather than 11.0% of gross domestic product, with Singapore's resulting health sector savings being re-directed to help fund both long-term care and retirement pensions for its elderly citizens. This paper contrasts the framework of financial risk-sharing and the configuration and management of health service providers in these two high-income, small-population countries. Two main institutional distinctions emerge from this country case comparison: (1) Key differences exist in the practical configuration of solidarity for payment of health care services, reflecting differing cultural roots and social expectations, which in turn carry substantial implications for financing long-term care and pensions. (2) Differing arrangements exist in the organization of health service institutions, in particular balancing public as against private sector responsibilities for owning, operating and managing these two countries' respective hospitals. These different structural characteristics generate fundamental differences in health sector financial and delivery outcomes in one developed country in Far East Asia as compared with a well-respected tax-funded health system in Western Europe. In the post-COVID era, as Western European policymakers find themselves forced to adjust their publicly funded health systems to (further) reductions in economic growth rates and overall tax receipts, and as the cost of the information revolution continues to rise while efforts to fund better coordinated social and home care services for growing numbers of chronically ill elderly remain inadequate, this two-country case comparison highlights a series of health system design questions that could potentially provide alternative health sector financing and service delivery strategies.

Health care coverage decisions may employ many different considerations, which are brought together across two phases. The assessment phase examines the available scientific evidence, such as the cost-effectiveness, of the technology. The appraisal then contextualises this evidence to arrive at an (advised) coverage decision, but little is known about how this is done.

In the Netherlands, the appraisal is set up to achieve a societal weighing and is the primary place where need- and solidarity-related (‘necessity’) argumentations are used. To elucidate how the Dutch appraisal committee ‘constructs necessity’, we analysed observations and recordings of two appraisal committee meetings at the National Health Care Institute, the corresponding documents (five), and interviews with committee members and policy makers (13 interviewees in 12 interviews), with attention to specific necessity argumentations.

The Dutch appraisal committee constructs necessity in four phases: (1) allowing explicit criteria to steer the process; (2) allowing patient (representative) contributions to challenge the process; (3) bringing new argumentations in from outside and weaving them together; and (4) formulating recommendations to societal stakeholders. We argue that in these ways, the appraisal committee achieves societal weighing rationality, as the committee actively uses argumentations from society and embeds the decision outcome in society.

In the last decades, several European health systems have abandoned their vertically integrated health care in favour of some form of managed competition (MC), either in a centralised or decentralised format. However, during a pandemic, MC may put health systems under additional strain as they are designed to follow some form of ‘organisational self-interest’, and hence face reduced incentives for both provider coordination (e.g. temporary hospital close down, change in the case-mix), and information sharing. We illustrate our argument using evidence for the Covid-19 pandemic outbreak in Italy during March and April 2020, which calls for the development of ‘coordination mechanisms’ at times of a health emergency.

Since the outbreak of the COVID-19 pandemic, discussions about the capabilities of health and social systems to control and contain infectious diseases have been reignited. In Resilient Managed Competition During Pandemics: Lessons from the Italian Experience, Costa-Font, Turatti and Levaggi ask whether or not institutional differences between the managed competition (MC) systems in three of Italy's regions may have affected their performance – and hence, population health outcomes – during the pandemic. Fuchs (2000) previously argued that institutional arrangements not only ‘matter’, but also sometimes ‘matter a great deal’ (p. 149, emphasis in original) and this may be particularly true in emergencies.

One of the main governance decisions that policymakers need to make is whether to implement public services via centralized or decentralized forms. As Costa et al. discuss in their article, when public services are implemented via competing systems, service providers contend to provide good services with the ultimate objective of gaining market quota. This is known as managed competition (MC), as the authorities will have to manage the panoply of public and private organizations offering the service. The alternative is to manage the service more centrally, in what it is identified as vertical integration. As the authors describe, several governments around the globe have abandoned their vertical integrated models in favour of decentralized models. This is the case, as the authors recall, for most health services in Europe. While there is an emerging body of evidence suggesting that decentralized MC outperforms vertically integrated models both in terms of efficiency and in terms of service quality, little is known on how these systems react under different circumstances. This means, for example, how these systems can cope with a sudden increase in their service demands.