This article examines the impact of the Health and Social Care Act 2012 on the regulation of competition in the English National Health Service (NHS), by focussing on the change it marked from a system of sector-specific regulation to one which is clearly based in competition law. It has been suggested that the Act and its associated reforms would significantly alter accountability in the NHS, and would change decisions from the remit of public policy to that of the law. To assess the impact the Act has had in practice, the article compares the interpretation of the rules regarding competition in the NHS by the regulators of competition immediately before, and following, the passing of the Act. It argues that, whilst the reforms have the potential significantly to alter the way competition in the NHS is regulated, the impact of the reforms in this area is limited by the development of systems within the NHS to manage and resolve issues internally where possible.

At least 100,000 retired UK citizens currently live in Spain. Under EU law, they are entitled to access the Spanish National Health Service (NHS) with minimum administrative difficulty. What will their legal position be under a ‘no-deal Brexit’? This is a question of Spanish law. The worst case scenario is that they will have to reapply for their residence permits under the Spanish legislation applicable to non-EU/European Economic Area citizens, with all the administrative inconvenience and cost entailed. If they successfully reapply, their personal health care costs will be considerably higher than at present, should they choose to remain in Spain. Very obvious questions of capacity planning arise. The Spanish system will potentially need to gear up for a significant administrative effort. Given the distinct possibility of a ‘no-deal Brexit’, the UK NHS should prepare to welcome significant numbers of pensioners home.

How does the concept of autonomy assist public responses to ‘lifestyle’ diseases? Autonomy is fundamental to bioethics, but its emphasis on self-determination and individuality hardly supports public health policies to eat and drink less and take more exercise. Autonomy rejects a ‘nanny’ state. Yet, the cost of non-communicable diseases is increasing to individuals personally and to public health systems generally. Health care systems are under mounting and unsustainable pressure. What is the proper responsibility of individuals, governments and corporate interests working within a global trading environment? When public health care resources are unlikely to increase, we cannot afford to be so diffident to the cost of avoidable diseases.

Where policy ends are contested and means for change are ambiguous, imposing central targets on local organisations – what we call hierarchist governance – is problematic. The concept of experimentalist governance suggests that target-setting should rather be a learning process between central regulators and local organisations. However, the relationship between experimentalist and hierarchist governance remains unclear. Existing literature suggests that the learning-oriented experimentalist logic is hard to reconcile with a hierarchist logic focussed on accountability for results. We examine whether complementary use of hierarchist and experimentalist ideas is possible. Drawing on experiences from Scotland, we find that experimentalist and hierarchist logics can co-exist in the same performance management system. Each logic served distinct roles with respect to target-setting, implementation and accountability. The emphasis on experimentalism was stronger where ends and means were contested (the case of shifting the balance of care for older people) than where both ends and means seemed obvious initially (the case of health care-associated infections, where target-setting followed a more hierarchist logic). However, governance drifted towards experimentalism when rising rates of community-acquired infections decreased clarity about effective interventions. The nature of policy issues and changes therein over time appear to be important conditions for synergies between governance logics.

In recent years, several emerging economies have introduced national health insurance programs ensuring access to health care while offering financial protection from out-of-pocket and catastrophic expenses. Nevertheless, in several nations these expenses continue to increase. While recent research has emphasized the lack of funding, poor policy design and corruption as the main culprits, little is known about the politics of establishing federal regulatory agencies ensuring that state governments adhere to national insurance reimbursement and coverage procedures. This article fills in this lacuna by providing an alternative perspective, one that accounts for differences between nations in the creation of regulatory institutions, with an emphasis instead on governing elite strategies to campaign on access to health care during transitions to democracy, civil societal mobilization, constitutional constraints and the national electoral incentives to overcome ineffective decentralization processes. The cases of Indonesia and China are introduced as examples of how and why their differences in this political process accounted for Indonesia’s success and China’s failure to ensure financial protection.

The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of ‘informed consent’ in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

The Joint Procurement Agreement (JPA) is an innovative instrument for multi-country procurement of medical countermeasures against cross-border health threats. This paper aims to assess its potential performance. A literature review was conducted to identify key features of successful joint procurement programmes. Documentary analysis and a key informants’ interview were carried out to analyse the European Union (EU) JPA. Ownership, equity, transparency, stable central financing, standardisation, flexibility and gradual development were identified as important prerequisites for successful establishment of multi-country joint procurement programmes in the literature while security of supply, favourable prices, reduction of operational costs and administrative burden and creation of professional expert networks were identified as desirable outcomes. The EU JPA appears to fulfil the criteria of ownership, transparency, equity, flexibility and gradual development. Standardisation is only partly fulfilled and central EU level financing is not provided. Security of supply is an important outcome for all EU Member States (MS). Price savings, reduction in administrative burden and creation of professional networks may be particularly attractive for the smaller MS. The JPA has the potential to increase health system collaboration and efficiency at EU level provided that the incentives for sustained commitment of larger MS are sufficiently attractive.

This paper examines a remarkable lawsuit in health care rationing. The Patients Association for Interstitial Cystitis sued the Dutch National Health Care Institute for alleged misconduct against Interstitial Cystitis patients, as the Institute decided that bladder instillations with chondroitin sulphate or hyaluronic acid are no longer covered by the basic health insurance. The patients’ organisation challenged the Institute for basing its standpoint on scientific evidence; overruling clinical expertise and patients’ experiences. While scientific advice is often solicited in public health issues, simultaneously, the authority of scientific advice is increasingly being questioned in the public domain. Also, the judiciary is frequently called upon to adjudicate in rationing decisions. Based on an ethnographic study of the National Health Care Institute, drawing on insights from the field of Science and Technology Studies, we analyse this lawsuit as a negotiation of what knowledge counts in reimbursement decisions.

Hoping to improve their health system performance, many countries have corporatised their hospitals in the past 20 years. What this means for hospital performance remains as yet largely unknown. This study looks into the association of corporatisation and hospital performance in Indonesia. We apply panel data regression analysis to survey data on 54 public hospitals in East Java province. Our analysis suggests that corporatisation is associated with higher hospital income and expenditure, but fails to improve efficiency and equity. These findings suggest that hospital corporatisation policy in Indonesia should increase emphasis on efficiency and equity rather than on financial performance alone.

This article reviews current trends in patent claims regarding personalised, stratified and precision medicine. These trends are not particularly well understood by policymakers, even less by the public, and are quite recent. Consequently, their implications for the public interest have hardly been thought out. Some see personalised and other secondary drug patent claims as promoting better targeted treatment. Others are inclined to see them as \manifestations of ‘evergreening’ whereby companies are, in some cases quite cynically, trying to extend market monopolies in old products or creating new monopolies based on supposedly improved versions of such earlier drugs. The article claims that the relaxation of ‘novelty’ is a privilege unavailable to inventions in other fields and that on balance the patent system does privilege this industry and that no adequate case has yet been made thus far to prove the public benefits overall.

In a health care system based on managed competition, health insurers negotiate on quality and price with care providers and are allowed to offer restrictive health plans. It is crucial that enrolees who need care choose restrictive health plans, as otherwise health insurers cannot channel patients to contracted providers and they will lose their bargaining power in negotiations with providers. We aim to explain enrolees’ choice of a restrictive health plan in exchange for a lower premium. In 2014 an online survey with an experimental design was conducted on members of an access panel (response 78%; n=3,417). Results showed 37.4% of respondents willing to choose a restrictive health plan in exchange for a lower premium. This fell to 22% when the restrictive health plan also included a longer travelling time. Enrolees who choose a restrictive health plan are younger and healthier, or on lower incomes, than those preferring a non-restrictive one. This means that enrolees who use care will be unlikely to choose a restrictive health plan and, therefore, health insurers will not be able to channel them to contracted care providers. This undermines the goals of the health care system based on managed competition.

In 2010 the Belgian government introduced a low cost administrative procedure for compensating medical injuries to overcome the major shortcomings of the existing tort system. This paper examines, for the first time, to what extent this reform had an impact on physician specialists’ defensive practices and what are the relevant determinants affecting physicians’ clinical decision making. Based on a survey of 508 physicians, we find evidence of a relatively modest increase in defensive practices among physicians in various specialties. In general, 14% of the respondents, who were aware of the reform, reported to have increased their overall defensive behaviour, while respectively 18 and 13% altered their assurance and avoidance behaviour. Commonly used physician characteristics, such as claims experience and gender, have a similar impact on defensive medicine as documented in existing literature. Furthermore, the determinant physician’s access to an incident reporting system is found to have a significant impact on most of the defensive medicine measures. Health care institutions may therefore play an important role in controlling and reducing physicians’ defensive practices.

Global discussions on universal health coverage (UHC) have focussed attention on the need for increased government funding for health care in many low- and middle-income countries. The objective of this paper is to explore potential targets for government spending on health to progress towards UHC. An explicit target for government expenditure on health care relative to gross domestic product (GDP) is a potentially powerful tool for holding governments to account in progressing to UHC, particularly in the context of UHC’s inclusion in the Sustainable Development Goals. It is likely to be more influential than the Abuja target, which requires decreases in budget allocations to other sectors and is opposed by finance ministries for undermining their autonomy in making sectoral budget allocation decisions. International Monetary Fund and World Health Organisation data sets were used to analyse the relationship between government health expenditure and proxy indicators for the UHC goals of financial protection and access to quality health care, and triangulated with available country case studies estimating the resource requirements for a universal health system. Our analyses point towards a target of government spending on health of at least 5% of GDP for progressing towards UHC. This can be supplemented by a per capita target of $86 to promote universal access to primary care services in low-income countries.

Regulatory theory is premised on the failure of markets, prompting a focus on regulators and industry from economic perspectives. This article argues that overlooking the public interest in the sustainability of commercial markets risks markets failing completely. This point is exemplified through health care markets – meeting an essential need – and focuses upon innovative medicines as the most desired products in that market. If this seemingly invulnerable market risks failure, there is a pressing need to consider the public interest in sustainable markets within regulatory literature and practice. Innovative medicines are credence goods, meaning that the sustainability of the market fundamentally relies upon the public trusting regulators to vouch for product quality. Yet, quality is being eroded by patent bodies focused on economic benefits from market growth, rather than ensuring innovatory value. Remunerative bodies are not funding medicines relative to market value, and market authorisation bodies are not vouching for robust safety standards or confining market entry to products for ‘unmet medical need’. Arguably, this failure to assure quality heightens the risk of the market failing where it cannot be substituted by the reputation or credibility of providers of goods and/or information such as health care professionals/institutions, patient groups or industry.

The United States’ experience with the Ebola virus in 2014 provides a window into US public health politics. First, the United States provided a case study in the role of suasion and executive action in the management of public health in a fragmented multi-level system. The variable capacity of different parts of the United States to respond to Ebola on the level of hospitals or state governments, and their different approaches, show the limitations of federal influence, the importance of knowledge and executive energy, and the diversity of both powerful actors and sources of power. Second, the politics of Ebola in the United States is a case study in the politics of partisan blame attribution. The outbreak struck in the run-up to an election that was likely to be good for the Republican party, and the election dominated interest in and opinions of Ebola in both the media and public opinion. Democratic voters and media downplayed Ebola while Republican voters and media focused on the outbreak. The media was a key conduit for this strategic politicization, as shown in the quantity, timing and framing of news about Ebola. Neither fragmentation nor partisanship appears to be going away, so understanding the politics of public health crises will remain important.