Developing architecture of system management in the English NHS: evidence from a qualitative study of three Integrated Care Systems.

OBJECTIVE: Integrated Care Systems (ICSs) mark a change in the English National Health Service to more collaborative interorganisational working. We explored how effective the ICS form of collaboration is in achieving its goals by investigating how ICSs were developing, how system partners were balancing organisational and system responsibilities, how partners could be held to account and how local priorities were being reconciled with ICS priorities. DESIGN: We carried out detailed case studies in three ICSs, each consisting of a system and its partners, using interviews, documentary analysis and meeting observations. SETTING/PARTICIPANTS: We conducted 64 in-depth, semistructured interviews with director-level representatives of ICS partners and observed eight meetings (three in case study 1, three in case study 2 and two in case study 3). RESULTS: Collaborative working was welcomed by system members. The agreement of local governance arrangements was ongoing and challenging. System members found it difficult to balance system and individual responsibilities, with concerns that system priorities could run counter to organisational interests. Conflicts of interest were seen as inherent, but the benefits of collaborative decision-making were perceived to outweigh risks. There were multiple examples of work being carried out across systems and 'places' to share resources, change resource allocation and improve partnership working. Some interviewees reported reticence addressing difficult issues collaboratively, and that organisations' statutory accountabilities were allowing a 'retreat' from the confrontation of difficult issues facing systems, such as agreeing action to achieve financial sustainability. CONCLUSIONS: There remain significant challenges regarding agreeing governance, accountability and decision-making arrangements which are particularly important due to the recent Health and Care Act 2022 which gave ICSs allocative functions for the majority of health resources for local populations. An arbiter who is independent of the ICS may be required to resolve disputes, along with increased support for shaping governance arrangements.

When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries.

The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation-through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.

Challenges of maintaining accountability in networks of health and care organisations: A study of developing Sustainability and Transformation Partnerships in the English National Health Service.

The English National Health Service (NHS) constitutes a unique institutional context, which combines elements of hierarchy, markets and networks. This has always raised issues about competing forms of accountability. Recent policy has emphasised a move from quasi market competition towards collaboration in the form of new regional organisational arrangements known as Sustainability and Transformation Partnerships (STPs). We explore accountability relationships in STPs, focusing on the challenges of increasing horizontal accountability given existing vertical accountabilities, most notably to national regulators. We utilize a case study approach concentrated on three Clinical Commissioning Groups (CCGs) in urban and rural settings in England. We conducted in-person interviews with 22 managers from NHS organisations and local authorities and examined local documents to obtain information on governance and accountability structures. The fieldwork was undertaken between November 2017 and July 2018. We analysed results by considering which actors were accountable to what forums and the nature of the obligation (vertical or horizontal). We found that individual organisations still retained vertical accountabilities and were reluctant to be held accountable for the whole STP, given they were responsible for only part of the joint effort. Moreover, organisations did not feel accountable to STPs and instead highlighted vertical accountabilities upwards to their own boards and to national regulators; and downwards to the public. But while local commissioning organisations, CCGs engaged with their members and the public, STPs failed to engage adequately with the public. Nevertheless, there were indications that horizontal accountability was starting to develop. This could become complementary to vertical accountability by facilitating mutual learning and peer review to anticipate and defer regulatory intervention. While vertical accountability is necessary to provide oversight and apply sanctions, it is not sufficient and should be accompanied by horizontal accountability.

Agreeing the allocation of scarce resources in the English NHS: Ostrom, common pool resources and the role of the state.

A challenge facing health systems such as the English National Health Service (NHS), which operate in a context of diversity of provision and scarcity of financial resources, is how organisations engaged in the provision of services can be encouraged to adopt collective resource utilisation strategies to ensure limited resources are utilised in the interests of service users and, in the case of tax funded services, the general public. In this paper the authors apply Elinor Ostrom's work concerning communities' self-governance of common pool resources to the development of collective approaches to the utilisation of resources for the provision of health services. Focusing on the establishment of Sustainability and Transformation Partnerships (STPs) in the English NHS, and drawing on interviews with senior managers in English NHS purchaser and provider organisations, we use Ostrom's work as a frame to analyse STPs, as vehicles to agree and enact shared rules governing the allocation of financial resources, and the role of the state in relation to the development of this collective governance. While there was an unwillingness to use STPs to agree collective rules for resource allocation, we found that local actors were discussing and agreeing collective approaches regarding how resources should be utilised to deliver health services in order to make best use of scarce resources. State influence on the development of collective approaches to resource allocation through the STP was viewed by some as coercive, but also provided a necessary function to ensure accountability. Our analysis suggests Ostrom's notion of resource 'appropriation' should be extended to capture the nuances of resource utilisation in complex production chains, such as those involved in the delivery of health services where the extraction of funds is not an end in itself, but where the value of resources depends on how they are utilised.

The regulation of competition and procurement in the National Health Service 2015-2018: enduring hierarchical control and the limits of juridification.

Since 1990, market mechanisms have occurred in the predominantly hierarchical National Health Service (NHS). The Health and Social Care Act 2012 led to concerns that market principles had been irrevocably embedded in the NHS and that the regulators would acquire unwarranted power compared with politicians (known as 'juridification'). To assess this concern, we analysed regulatory activity in the period from 2015 to 2018. We explored how economic regulation of the NHS had changed in light of the policy turn back to hierarchy in 2014 and the changes in the legislative framework under Public Contracts Regulations 2015. We found the continuing dominance of hierarchical modes of control was reflected in the relative dominance and behaviour of the sector economic regulator. But there had also been a limited degree of juridification involving the courts. Generally, the regulatory decisions were consistent with the 2014 policy shift away from market principles and with the enduring role of hierarchy in the NHS, but the existing legislative regime did allow the incursion of pro market regulatory decision making, and instances of such decisions were identified.

The regulation of competition in the National Health Service (NHS): what difference has the Health and Social Care Act 2012 made?

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.

Divergence of NHS choice policy in the UK: what difference has patient choice policy in England made?

OBJECTIVES: To examine the types of choices available to patients in the English NHS when being referred for acute hospital care in the light of the divergence of patient choice policy in the four countries of the UK. METHODS: Case studies of eight local health economies in England, Scotland, Northern Ireland and Wales (two in each country); 125 semi-structured interviews with staff in acute services providers, purchasers and general practitioners (GPs). RESULTS: GPs and providers in England both had a clear understanding of the choice of provider policy and the right of patients to choose a provider. Other referral choices potentially available to patients in all four countries were date and time of appointment, site and specialist. In practice, the availability of these choices differed between and within countries and was shaped by factors beyond choice policy, such as the number of providers in an area. There were similarities between the four countries in the way choices were offered to patients, namely lack of clarity about the options available, limited discussion of choices between referrers and patients, and tension between offering choice and managing waiting lists. CONCLUSIONS: There are challenges in implementing pro-choice policy in health care systems where it has not traditionally existed. Differences between England and the other countries of the UK were limited in the way choice was offered to patients. A cultural shift is needed to ensure that patients are fully informed by GPs of the choices available to them.