Jonathan Montgomery

Nursing and the law

This book presents and explains those parts of the law which are relevant to the nursing profession. It aims to inform nurses of their rights, and those of their patients, and demonstrate that the law protects rather than threatens them. After introducing the legal system, the authors relate the relevant parts of the law to particular groups of patients. They have attempted to make the book accessible to those who have no prior knowledge of the legal system.

Research led by participants: a new social contract for a new kind of research

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

Standards of professional conduct

Nurses have considerable power in that patients depend upon them, directly and intimately, and their standards of professional conduct. If a nurse makes a mistake or drops below the proper level of care then harm may be caused to patients and to the public reputation of nursing.

Medicine, Accountability, and Professionalism

If one asks how the medical profession is made legally accountable in England and Wales, the answer is essentially very simple: accountability is achieved through a professional filter. Medical practice is, in effect although not technically in law a professional monopoly, its ethical standards are set and policed by medics, and malpractice suits are almost exclusively based on negligence which turns out to make liability depend on the expert opinions of doctors. While judges have suggested that they might intervene to establish standards, actual activity of this sort has been conspicuous by its absence. The purpose of this paper is to examine how this situation has come about, to examine the ideological framework which serves to legitimate it, and to appraise its current validity. It suggests that law in England and Wales has been dominated by an acceptance of the claims of medical professionalism.1 Following the work of Terence Johnson, this term is taken to denote a particular type of contfol of occupational activity by which it is the producer who defines not only the needs of the consumer but also the manner in which these needs are to be met.2

Lancet Commission: Stem cells and regenerative medicine

In this Commission, we argue that a combination of poor quality science, unclear funding models, unrealistic hopes, and unscrupulous private clinics threatens regenerative medicines social licence to operate. If regenerative medicine is to shift from mostly small-scale bespoke experimental interventions into routine clinical practice, substantial rethinking of the social contract that supports such research and clinical practice in the public arena will be required. For decades, stem cell therapy was predominantly limited to bone marrow transplantation for haematological diseases and epidermis transplantation for large burns. Tissue engineering and gene therapy faced huge challenges on their way to clinical translation—a situation that began to change only at the end of the 1990s. The past 10 years have seen an exponential growth in experimental therapies, broadly defined as regenerative medicine, entering the clinical arena. Results vary from unequivocal clinical efficacy for previously incurable and devastating diseases to (more frequently) a modest or null effect. The reasons for these widely different outcomes are starting to emerge. At this stage in their evolution, these experimental therapies (which include, but are not limited to, cell and gene therapy, tissue engineering, and new generation drugs) are necessarily financially expensive. Rigorous and costly clinical-grade procedures have to be followed in the development of medicinal products (involving cells, genetically manipulated cells, viral vectors, or biomaterials with or without cells), often produced in a very limited run. The cost of developing sufficiently high-quality trials means that only wealthier countries are able to fund them. Although public investments in this field are massive internationally, they do not carry guaranteed commercial returns. Compared with conventional drug development, such products follow a highly uncertain route to market. Furthermore, new therapies expose patients to risks, some of which are difficult to predict even with inbuilt safeguards. Despite the relatively small number of clinical successes, optimism and excitement about the potential effect or implications of this field remain great. This enthusiasm has led to gaps between peoples expectations that new therapies should be available, often inflated by media reports, and the realities of translating regenerative technologies into clinical practice. The same environment is also permissive of one-off compassionate applications and poorly regulated trials. Indeed, the number of poorly regulated clinics has grown; clinics that appeal to desperate patients and their families, who, in the absence of reliable clinical knowledge from trials, cannot be adequately informed to assess the risks and benefits. These ethical and governance issues pose a challenge to scientists in engaging with the public, the press, and decision-making bodies in different national health systems. Political agendas might not coincide with the public good. In poorly regulated states, the authorisation of a novel therapy might be politically attractive, even when efficacy is unconfirmed, and the cost to taxpayers means other patients are deprived of established and effective therapies. These challenges are difficult to address and solve. We recommend a solution that lies in a coordinated strategy with four pillars: better science, better funding models, better governance, and better public and patient engagement.

Montgomery on informed consent: an inexpert decision?

Montgomery v Lanarkshire HB is a deeply troubling decision when read closely. Paradoxically, its ruling supporting the principle of autonomy could be justified only by disregarding the individual patients actual choices and characteristics in favour of a stereotype. The decision demonstrates a lack of expertise in dealing with specific clinical issues and misrepresents professional guidance. More fundamentally, it fails to appreciate the nature of professional expertise. This calls into question the competence of the courts to adjudicate on matters of clinical judgement and makes an attractive formulation of the test for disclosure obligations inherently unpredictable.

“No decisions about us without us”? Individual healthcare rationing in a fiscal ice age

Jill Russell and colleagues examine whether patients and the public should be involved in rationing decisions about individual patient access to healthcare interventions

Addressing the ‘postcode lottery’ in local resource allocation decisions: a framework for clinical commissioning groups

The NHS Constitution emphasizes patients’ rights to expect these decisions to be made ‘rationally’. The National Prescribing Centre (NPC), now the Medicines and Prescribing Centre at the National Institute for Health and Clinical Excellence, has directed considerable effort in recent years at defining the parameters of rational decisionmaking, and supporting PCTs in improving their approaches to prioritization and resource allocation. The NPC, commissioned by the Department of Health, embarked on a systematic process to develop a national ‘competency framework’ resource for those involved in making difficult prioritization decisions at a local level.This paper reports on how the NPC competency framework was developed, and presents a potentially transferable methodology for advancing a competency framework to support individual and organizational learning and improvement

A new social contract for medical innovation.

Despite burgeoning knowledge about the origins of disease founded on scientifi c advances, there are increasing public concerns that medical innovation is not helping patients in need fast enough. In the UK, Lord Saatchi’s proposal for a Medical Innovation Bill is one manifestation of this concern, while the Minister for Life Sciences’ current Innovative Medicines and Medical Technologies Review is another. A review of medical innovation is timely; it is not just the time taken for research, but the rising cost of drug development that demand attention. The adoption and diff usion of new technologies and medicines of marginal incremental benefi t is one of the biggest drivers of cost in health systems, and contributes to their unsustainability. Although the pharmaceutical industry understandably seeks to recover the costs of drug development, commissioners of health services adopt policies and processes that eff ectively ration the availability of new products. Recent analyses highlight that in a universal health system such as the UK’s National Health Service (NHS) with a fi nite budget, money spent on expensive drugs could achieve more health benefi t if directed elsewhere. Any revision to the medical innovation process needs to embrace advances in genomics, data analytics, and e-health technologies, which have the potential to transform health and health care. We will soon be able to use population data to inform interventions that improve the health of individuals. Unlike the “one size fi ts all” population-based strategy that delivered the blockbuster drugs of the past, the future of medicine is likely to be shaped by 4P medicine that is predictive, pre-emptive, personalised, and participatory. Such an approach has the potential to tackle the rising tide of chronic diseases and transform health care from disease-orientated provision to a true health maintenance service. But are we ready for the revolution? Moving to 4P medicine will require the engagement of patients, health professionals, health-care organisations, regulatory agencies, and commissioners with alignment of their respective interests and imperatives. This process is unlikely to occur if left to chance. Rather, we must address fundamental questions about the economic, social, and behavioural factors that determine the capability and willingness of individuals, organisations, and society to fi nance and adopt medical innovations. Such understanding should lead to a review of the social contract between the health system and the citizen that sets a policy framework to guide the adoption of medical advances. Consideration should be given to the discrete market size for personalised therapies and the complex ways to value and pay for such innovation, which include informing those who invest in innovation earlier in the process and assuring developers of the likely market. Another economic challenge is to ensure that inequality of access to 4P medicine does not follow from wealth inequity. In high-income countries, life expectancy is increasing as the birth rate falls. The rising costs of care for older people fall on a shrinking workforce. How will this change aff ect our capacity and willingness to fund 4P medicine? Since wealthier people are more willing to invest in preventive health care, future health outcomes in old age could become even more dependent on wealth, and exacerbate inequalities and confl icts about fi nancing because the heaviest users of health services will be the poor. Moreover, health inequalities between countries will be exacerbated if pharmaceutical investment prioritises precision medicine at the expense of research tailored to the needs of poorer nations. Technological advances require parallel progress in the communication of value, risk, and uncertainty to the public in ways that foster trust and enable informed choice and optimum engagement. It is also important to recognise that people with unmet clinical need

Bioethics as a Governance Practice.

Bioethics can be considered as a topic, an academic discipline (or combination of disciplines), a field of study, an enterprise in persuasion. The historical specificity of the forms bioethics takes is significant, and raises questions about some of these approaches. Bioethics can also be considered as a governance practice, with distinctive institutions and structures. The forms this practice takes are also to a degree country specific, as the paper illustrates by drawing on the author’s UK experience. However, the UNESCO Universal Declaration on Bioethics can provide a starting point for comparisons provided that this does not exclude sensitivity to the socio-political context. Bioethics governance practices are explained by various legitimating narratives. These include response to scandal, the need to restrain irresponsible science, the accommodation of pluralist views, and the resistance to the relativist idea that all opinions count equally in bioethics. Each approach raises interesting questions and shows that bioethics should be studied as a governance practice as a complement to other approaches.