Medicine, patients and the law

Sixth edition

Margaret Brazier

• Publisher: Manchester University Press
• Year: 2016
• ISBN:
  9781526100511
• Edition: 1
• Topic: Law
• Subtopic: Medical Law
• Index: Law

Embryo research, cloning, assisted conception, neonatal care, saviour siblings, organ transplants, drug trials - modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up.In this highly acclaimed and very accessible book, now in its sixth edition, Margaret Brazier and Emma Cave provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The book has been fully revised and updated to cover the latest cases, from assisted dying to informed consent; legislative reform of the NHS, professional regulation and redress; European regulations on data protection and clinical trials; and legislation and policy reforms on organ donation, assisted conception and mental capacity. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.

Part I

MEDICINE, LAW AND SOCIETY

Chapter 1

THE PRACTICE OF MEDICINE TODAY

1.1 In 2016, medicine and healthcare in England appear immersed in crisis after crisis. An account of how the law regulates medicine thus must begin by examining, if briefly, the context within which medicine, patients and the law interact. In 2004, the distinguished physician Professor Ray Tallis could confidently note that few professions still stood so high in public esteem as medicine.¹ A series of scandals revealing poor care and sometimes disregard of patients’ welfare have put health professionals under much critical scrutiny. A barrage of reforms designed to improve patient safety did not prevent appalling suffering at Stafford Hospital between 2005 and 2009. Three inquiries ensued. The first report, in 2010, featured distressing accounts made by patients and their families. There was evidence of filthy conditions, food and water left out of reach of patients, and indifference to patient needs. The report focused on the failings of the Trust, highlighting the ill-effects of a strategic focus on financial targets.² The second inquiry considered the failure of monitoring arrangements to put things right.³ In combination, the two reports revealed:

a culture of fear in which staff did not feel able to report concerns; a culture of secrecy in which the trust board shut itself off from what was happening in its hospital and ignored its patients; and a culture of bullying, which prevented people from doing their jobs properly.⁴

The third – the ‘Francis Inquiry’– in which over 250 witnesses and over a million pages of documentary material were considered, investigated why the NHS system failed to detect these problems earlier.⁵ Constant NHS reorganisation, regulatory gaps and ineffective communication contributed to the problem. Care of patients was not at the heart of the work of the Mid Staffordshire NHS Foundation Trust. Further policy change, reorganisation and the identification of scapegoats, it was concluded, will not bring about the necessary change. Culture change, ‘a refocusing and recommitment of all who work in the NHS – from the top to the bottom of the system – on putting the patient first’,⁶ must be brought about through clear standards, transparency, support for nursing, strong leadership and accurate information.⁷

In April 2014, Mid Staffordshire NHS Foundation Trust was fined £200,000 for breaches of the Health and Safety at Work Act which led to the death of a diabetic patient, Gillian Astbury.⁸ Days after the sentence was passed, it was announced that the Trust would be dissolved.

The crisis at Stafford Hospital tops a list of scandals that have dealt blow after blow to the reputation of the medical profession in the United Kingdom. Surgeons carrying out cardiac operations on infants in Bristol were found to have continued to operate despite incurring higher death rates for such surgery than their peers.⁹ The Bristol Inquiry¹⁰ uncovered a ‘club culture’.¹¹ Staff were caring and well motivated, but care was badly organised; the standard of care was poor and there was a lack of effective communication. In Bristol, and in Liverpool,¹² evidence emerged of hospitals retaining children’s organs without their parents being told that only parts of their children’s bodies were returned to them for burial. Subsequently, it became apparent that organ retention in relation to children and adults was a widespread practice.¹³ Harold Shipman was convicted of fifteen counts of murder and later found to have killed at least 215 of his patients.¹⁴ Appalling reports of degrading treatment of learning disabled people in NHS establishments surfaced in 2006¹⁵ and mistreatment of patients at Winterbourne View hospital in 2011 resulted in criminal prosecutions and imprisonment of staff.¹⁶ In 2015 an independent inquiry into the deaths of mothers and babies at Furness General Hospital between 2004 and 2013 found twenty instances of significant or major failures of care. Staff colluded to conceal the truth and the regulators missed a series of opportunities to act.¹⁷ The same year, a Greater Manchester nurse, Victorino Chua, was convicted of murdering two patients and poisoning twenty others by injecting insulin into saline bags.¹⁸ These so-called ‘scandals’ reflect poorly on individuals, but also on the NHS, which promises to ensure a safe service of the quality that patients and their families are entitled to expect.¹⁹ That the crisis at Stafford Hospital occurred at all is bad enough. That it occurred post-Bristol Inquiry indicates systemic failure. The Francis Inquiry has led to change across the tiers of regulation.²⁰ The Health and Social Care (Safety and Quality) Act 2015²¹ now imposes an obligation on the Secretary of State to ensure that no avoidable harm is caused to service users. This has the effect of transferring additional powers to the Secretary of State to make relevant regulations.

Tiers of regulation

1.2 Four distinct tiers of regulation have been identified. First, personal regulation involves a doctor’s individual commitment to a code of ethics, found in part in documents such as the Hippocratic Oath and the General Medical Council’s Good Medical Practice guidance.²² We consider the ethical responsibilities of doctors in Chapter 3. Second, team-based regulation requires all healthcare professionals to take responsibility for their team’s performance and conduct. Third, professional regulation, which we consider in the below, is undertaken by statutory regulators such as the General Medical Council (GMC) and the Nursing and Midwifery Council (NMC)²³ which are overseen by the Professional Standards Authority (PSA)²⁴ which monitors nine healthcare regulators, sets standards and enhances consistency. Finally, work-based regulation involves a system of clinical governance and performance management, which we consider in the latter half of this chapter.

In recent years the medical profession has witnessed an unprecedented increase in all four types of regulation. Reforms of the GMC continue apace. Recent work-based regulations emphasise monitoring designed to ensure good practice rather than simply reacting to bad practice. The Health and Social Care Act 2012 removed tiers of management and streamlined arm’s-length bodies. The Act aimed to give doctors control – to ‘liberat[e] the NHS from central control and political interference’.²⁵ It was hoped that transparency, competition and choice would promote a rise in standards and patient safety. The Francis Inquiry showed that this was not enough. In the wake of the 2012 reforms, the spotlight is very much on the healthcare regulators.

The various tiers of regulation do not always work in harmony. Work-based regulation is designed not only to enhance patient safety, but also to ensure the economic accountability of NHS organisations. Job freezes and staff cuts have an impact on the level of care a hospital can provide. Economy may compromise safety and reduce the ability of the individual doctor to offer the kind of care that she might wish to deliver.

The National Health Service

1.3 How well doctors can do their job is in part dictated by the environment in which they work. In England, most healthcare is still provided within the NHS. While spending on healthcare in the UK has more than doubled in cash terms in the last decade, this is offset by the ever growing capacity of technology, an ageing population and increased incidence of chronic disease. As the government imposes freezes and cuts in funding in order to reduce the fiscal deficit, measures to increase efficiency are increasingly prominent.

Since 1974, the NHS has been subject to a steady stream of political reform.²⁶ Such constant change does not help doctors and nurses do their jobs. In 1991, NHS Hospital trusts were first created and the NHS divided into ‘purchasers’ and ‘providers’. The Conservative government introduced the internal ‘market’ and GP fundholding in 1995. GP fundholding was abolished by the incoming Labour government in 1997. Twenty-eight Strategic Health Authorities (SHAs) were created in 2001 to manage the performance of the NHS locally and 303 Primary Care Trusts (PCTs) provided health services. New emphasis was placed on decentralisation: a patient-led NHS. Focus on patient choice led to the reinstatement of competition between Trusts in 2004, and in 2006 the existing SHAs merged into 10 and the 303 PCTs merged into 152, reminiscent of the regional offices and Health Authorities abolished in 2001.

Commissioning is central to the NHS.²⁷ Primary care is the ‘front line’ of the NHS. The local surgery is often the patient’s first point of contact. There she can see a range of healthcare professionals, such as a nurse, GP or midwife and access a range of services. PCTs were established in 2000 to plan and commission services for the locality. From April 2003, 75 per cent of the NHS budget devolved to PCTs.²⁸ PCTs could devolve their responsibilities to GP practices...