Medicine, patients and the law: Sixth edition

By Margaret Brazier and Emma Cave

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.

• Language: English
• Publisher: Manchester University Press
• Release date: Oct 7, 2016
• ISBN: 9781526100511

Margaret Brazier

Margaret Brazier is Professor in the Centre for Social Ethics and Policy in the School of Law at the University of Manchester

Book preview

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 (or groups of GP practices) which were given indicative budgets and allowed to commission services (‘Practice Based Commissioning’).²⁹

A much bigger transfer of power followed the enactment of the Health and Social Care Act 2012.³⁰ During the passage of the Bill, the weight of criticism forced the government to make an unprecedented ‘pause to listen’. Despite the concessions that followed, the Act remains the biggest overhaul of the NHS in living memory. The 2012 Act removed much of the strategic management of the NHS from governmental control. Around 170 organisations were disbanded and 240 new ones created.³¹ The Act abolished SHAs and PCTs³² and brought about a wholesale devolution of commissioning powers to local consortia of GP practices called ‘Clinical Commissioning Groups’. The transformation took place in waves between 2012 and 2013. The market framework which allows private companies to bid for NHS work (subject to regulations) has been much criticised.³³

The £95 billion commissioning budget is now the responsibility of a body (set up in April 2013) called NHS England.³⁴ NHS England determines the services required and sets a pricing structure. The Act also extends the responsibilities of the Independent Regulator of NHS Foundation Trusts, Monitor,³⁵ to incorporate the setting and publication of ‘the national tariff’.³⁶ The two bodies work in conjunction to consult upon and publish the tariff.³⁷

NHS England commissions specialist and GP services,³⁸ but its primary role is to empower and support³⁹ around 200 Clinical Commissioning Groups which take on the majority of commissioning of NHS Services in England. To facilitate the integration of health and social care, regulations provide for pooled budgets across Clinical Commissioning Groups and the health-related and social care functions of local authorities.⁴⁰ Commissioning is also undertaken by a new executive agency, Public Health England, which alongside local authorities commissions public health services.

To hold the commissioning bodies to account, a series of Outcomes Frameworks have been developed: one each for the NHS, public health, adult social care and health education. The Public Health Outcomes Framework⁴¹ focuses on patient longevity and quality of life. Quarterly online publication of results uses a ‘traffic light’ system⁴² indicating trends across the region. The NHS Outcomes Framework⁴³ includes five key indicators:

(1)  preventing people from dying prematurely;

(2)  enhancing quality of life for people with long-term conditions;

(3)  helping people to recover from episodes of ill health or following injury;

(4)  ensuring that people have a positive experience of care; and

(5)  treating and caring for people in a safe environment and protecting them from avoidable harm.

The focus of the fourth and fifth outcomes (on satisfaction and safety) moves beyond the tradition of improving ‘health’ in the narrow sense, to a new emphasis on ‘well-being’. The Frameworks are intended to operate not only as a performance indicator but as a means of driving improvements in quality through a new commitment to transparency and openness. This is aided through the creation of a new non-departmental public body: the Health and Social Care Information Centre,⁴⁴ which has powers to require health and social care bodies to provide and publish information.

Data collected in compliance with the Outcomes Frameworks is used to hold the various sectors of the health service to account. It is also used to inform patients and help them make a range of choices about their providers, clinicians and treatment. The powers to choose are described in the annually updated NHS Choice Framework.⁴⁵ For people who are not in hospital but have continuing health needs, it is possible to agree with relevant healthcare professionals a personal health budget giving the patient the power to prioritise certain well-being outcomes and to spend in line with the plan.⁴⁶

Patients needing to go to hospital for treatment or diagnosis can choose to which hospital they want to be referred by their GP. A website allows patients to look at the performance of individual hospitals. This potentially creates a perverse incentive to hide adverse events, but hospitals with a lower-than-expected rate of adverse incidents are followed up.⁴⁷

In some circumstances, patients might choose a different type of provider: NHS England commissions services from ‘any qualified provider’ (AQP). To qualify, the provider must register with the Care Quality Commission or meet equivalent requirements, and must be willing to comply with the NHS Standard Contract, for the price set in either the national tariff or by local commissioners.

Patients also have choices to make about primary care. Whereas previously, patients chose a GP practice from within their catchment area, since January 2015 they can register with a participating practice most convenient to them. They might, for example, choose a practice that is nearer to work than home. The responsibility to offer home visits to patients outside their GP’s practice boundary falls to NHS England and this inevitably impacts on their ability to plan services. Will more affluent patients seeking treatment that not all GPs provide travel to a practice which does, leaving poorer, less mobile patients with much more limited choices?

New freedoms in commissioning are matched by increased autonomy for providers. Foundation Trusts (FTs) were established by the Health and Social Care (Community Health and Standards) Act 2003.⁴⁸ They are authorised and regulated by ‘Monitor’; an independent regulator established in 2004.⁴⁹ FTs differ from NHS Trusts in a number of ways. While subject to NHS inspection and standards, they are independent, not-for-profit public benefit corporations with unique governance arrangements. Led by an independent Board of Directors, they are more locally accountable. Investment from both the public and private sectors is encouraged.⁵⁰

The aim was for all NHS Trusts to be given the opportunity to apply for Foundation Trust status by 2008. Momentum was lost, but rekindled with the passage of the 2012 Act following which the NHS Trust Development Authority (TDA) was set up⁵¹ to guide NHS Trusts seeking FT status. Hopes that most NHS trusts would become FTs by 2014, proved ill founded. At the end of 2013 there were 147 Foundation Trusts with 98 Trusts yet to achieve FT status. NHS Trusts are finding it difficult to meet the standards set by Monitor. There is no formal cut-off point, but the Secretary of State has the power to abolish remaining NHS Trusts. And their difficulties do not end with the achievement of FT status. In 2015 it was reported that the net deficit of Foundation Trusts is £321m (a staggering £269m behind plan).⁵² A shortage of emergency beds and increase in people attending Accident and Emergency departments compounded the pressures on operational performance.

The NHS operates in a system of finite – and increasingly limited – resources. A Health Committee review in 2013 found that the NHS reforms had indeed resulted in savings but questioned their sustainability.⁵³ The NHS Forward View⁵⁴ in October 2014 set out a plan to address this problem. New efficiency measures might account for two-thirds of the £30bn shortfall up to 2020, but investment of around £8bn must come from government.

Angels or demons?

1.4 Good medical care requires more than sets of regulatory rules. Great demands are made of individual health professionals. Praised to the skies for their triumphs, few individuals attract greater public odium than the doctor or nurse who falls from her pedestal. The revulsion occasioned by Nazi atrocities in the concentration camps was nowhere as marked as in the case of Dr Mengele. That he used his skills as a doctor, taught to him that he might heal and comfort the sick, to advance torture and barbarism caused horror.

Public passion is rightly aroused by the likes of Mengele and Shipman. Passion is never far away from everyday relationships between doctor and patient. When doctors meet their patient’s expectations, they are rewarded by admiration and affection. Woe betide them if they do not. One error, one moment of exasperation or insensitivity, may transform a beloved doctor into a hate figure. Consultants were once accorded godlike status. They inspired awe visiting the ward attended by a retinue of junior doctors and nurses. Their exalted status insulated them from personal contact with patients and protected them from the sort of complaints voiced freely to nursing staff. They paid a price. Gods are expected to work miracles. They are not expected to be subject to human error. When a consultant proved to be human, when medicine could not cure, the patient found it hard to comprehend failure and rightly or wrongly, often wrongly, regarded the doctor as personally incompetent.

Medical attitudes are changing. Family doctors are becoming a different breed. Many try hard to persuade patients to see their doctor as a partner in promoting good health. Doctors are urged to prescribe less freely and to talk more to their patients. The good GP is as interested in the prevention of ill-health as its cure. A new generation of consultants is taking over in the hospitals. They are (in most cases) less grand and more prepared to listen to patients and nursing staff.

One, or even several, ‘bad apples’ should not destroy the reputations of thousands of other medical practitioners who do their job diligently and compassionately. All professions have their miscreants. The medical profession should not be punished for Shipman’s bizarre and apparently motiveless murders. The heart of the problem and the damage to the ‘image’ of medicine is that too little is sometimes seen to be done by the profession and its regulators to identify and remedy doctors’ failings. It seems amazing that no colleague noted or acted on evidence of the number of apparently healthy patients on Shipman’s list who died suddenly, in certain cases even in his surgery.

There are features of the profession of medicine which will render doctors more vulnerable to attack than other professionals. The doctor deals with the individual’s most precious commodity, life and health. On a mundane level she may determine whether patient X is to be sanctioned to enjoy seven days off work for nervous exhaustion brought about by overwork, or classified as another malingerer.⁵⁵ At the other end of the scale, the doctor may hold in his hands the power of life and death. He is the man with the skill and experience. In his hands, as the patient sees it, rests the power to cure. As Ian Kennedy has said, the patient appears before the doctor ‘naked both physically and emotionally’.⁵⁶ It is hard to overstate the power vested in doctors. The price of power is that those who exercise it must expect constant scrutiny from those subject to it and from the public at large. The age of deference is past. Doctors cannot be surprised when failure, incompetence or controversy attracts equal notoriety. Unfortunately, representatives of the profession sometimes react in an over-defensive manner, exacerbating the original criticism or complaint.

Whistle-blowing

1.5 When healthcare goes badly wrong it will often be a health professional who brings the problems to public attention. The Public Interest Disclosure Act 1999 is designed to protect whistle-blowers, but whistle-blowing at Mid Staffordshire proved woefully inadequate.⁵⁷ Progress is evident. The Enterprise and Regulatory Reform Act 2013 safeguards whistle-blowers and protects employers from spurious claims.⁵⁸ It extends the circumstances in which an employer can be held vicariously liable when a whistle-blower is harmed by the acts of other employees⁵⁹ and rules out ‘gagging orders’ which had reportedly become prevalent.⁶⁰ But underlying cultural issues limit effectiveness. An NHS staff survey in 2015 revealed that only 68 per cent of staff were confident that it is safe to raise a concern.⁶¹ Policies encouraging openness are not matched with appropriate support. An independent review chaired by Sir Robert Francis QC⁶² listed the principles and actions that regulators and employers need to take to initiate change. The review also recommended additional legal protections for whistle-blowers.⁶³

A duty of candour

1.6 Increasing protections for whistle-blowers are accompanied by new emphasis on the duty of individual healthcare professionals and providers to report errors and incidents. The ‘duty of candour’ is (since 2013) a prominent feature of both the NHS Constitution and NHS Standard Contract. Furthermore, recognition that the duty of candour extends to providers is reflected in licensing and registration requirements by which healthcare providers must abide.⁶⁴ Section 81 of the Care Act 2014 makes provision for a new statutory duty of candour.⁶⁵ It came into force from November 2014 for NHS providers and April 2015 for independent providers.⁶⁶ There are now financial implications for failing to be open with patients and families and a criminal offence is committed when providers required by law to give information, do so in a false or misleading manner. The GMC and NMC produced joint guidance for professionals in 2015.⁶⁷

Entitlement to practise

1.7 One of the crucial functions of regulation is to ensure the competence of professionals offering services to the public. So who is entitled to practise medicine? The GMC maintains a register of medical practitioners and in 2009 the licence to practise was introduced⁶⁸ as part of reforms aiming to monitor doctors in order to assess their accordance with principles of Good Medical Practice.⁶⁹ Only registered practitioners can apply for a licence. Both registration and a licence are required to perform certain tasks such as writing prescriptions or signing death certificates and a criminal offence is committed when a person deliberately and falsely represents himself as being a registered and licensed practitioner or having a medical qualification.⁷⁰ However, unregistered and unlicensed practitioners can still use the title ‘doctor’. No law expressly prohibits any unregistered, unlicensed or unqualified person from practising most types of medicine or even surgery. The rationale of the criminal law is that people should be free to opt for any form of advice or treatment, however bizarre, but must be protected from rogues claiming a bogus status and from commercial exploitation of untested ‘alternative’ medicine.

A tradition of self-regulation – to be consigned to history?

1.8 By virtue of the Medical Act 1983, the regulation of the medical profession was entrusted to the profession itself acting through the GMC, continuing a tradition of self-regulation, endorsed by Parliament, dating back to 1858. Prior to 1858, there were in effect three separate medical professions, the physicians, the surgeons, and the apothecaries. The Royal Colleges of Physicians and Surgeons wielded great power. Those colleges, joined later by others, for example, the Royal College of Obstetricians and Gynaecologists, continued to control specialist education and specialist practice. Self-regulation has long been the hallmark of the learned professions. Doctors’ patients and lawyers’ clients were increasingly unconvinced that the professional regulators protected public interests. The GMC came under especially vigorous attack. Its composition was seen as too biased in favour of the doctors, and its capacity to ensure that patients were treated by competent doctors truly fit to practise was doubted. Thus although the Medical Act 1983 remains on the statute book, it has been radically amended by statutory instruments in 2002, 2006, 2007, 2008, 2010 and 2014.⁷¹

The Medical Act 1983 (Amendment) Order 2002 sets out the central tenet of all attempts to reform the GMC. It amends section 1 of the 1983 Act so that section 1A says simply:

The main objective of the General Council in exercising their functions is to protect, promote and maintain the safety of the public.

Over time, a second role has developed: to promote public confidence in the profession. This has received judicial recognition⁷² and is now incorporated in legislation. The Health and Social Care (Safety and Quality) Act 2015 gives certain health and social care regulators an overarching objective of ‘public protection’⁷³ and requires them to have regard to this objective in fitness-to-practise proceedings. Public protection includes promoting and maintaining safety and public confidence in the profession.

Historically, while the GMC has policed admission to the medical register, little was done to ensure that a doctor continued to be competent, and up to date, in her practice. She remained ‘licensed’ to practise, unless disciplinary proceedings, or health or performance procedures were invoked against her. Amendments to Part III of the 1983 Act introduce a scheme for revalidation of medical competence. The GMC issues doctors a licence to practise on first registration. Doctors are required to renew that licence periodically, proving their continued competence through a scheme of continuing evaluation of practice. Delayed by the restructuring of the NHS, the long-awaited revalidation scheme was rolled out from 2012.⁷⁴ The GMC hopes to complete the first wave of revalidations by March 2016.

If the absence of processes to monitor doctors’ competence caused public concern, what were seen as feeble and apparently prejudiced disciplinary proceedings to deal with complaints against doctors aroused anger.⁷⁵ The historic concept of ‘infamous conduct in a professional respect’ was replaced by the notion of ‘serious professional misconduct’ in the Medical Act 1969. Critics still argued that the threshold of what constituted such misconduct was set too high, and when a finding of misconduct was made, penalties were too lenient. Thus, in 2002 the whole of the existing system for disciplining defaulting doctors, dealing with sick doctors, and addressing under-performing doctors was revised.

The critics were far from satisfied. Dame Janet Smith’s inquiry⁷⁶ into the Shipman debacle led to a review of medical regulation by the Chief Medical Officer (CMO), Sir Liam Donaldson. The CMO published a consultation document Good Doctors, Safer Patients in 2006, concluding that the GMC is ‘too secretive, too tolerant of sub-standard practice and too dominated by the professional interest, rather than that of the patient’.⁷⁷ Sir Liam recommended a further shake-up of the GMC. The Health and Social Care Act 2008 provided for a new independent body, the Office of the Health Professions Adjudicator (OPHA) to take over the adjudication of fitness-to-practise cases.⁷⁸ But a U-turn in 2010 led instead to new measures designed to strengthen the GMC processes. Mark Davies argues that, while the GMC has responded to challenges to its powers with inventiveness, reforms, such as revalidation, are increasingly state-led.⁷⁹ A watered-down state of self-regulation endures.

Composition of the General Medical Council

1.9 Who the regulators are influences how confident the public will be in the process and objectivity of the regulatory framework. In 1983, the GMC comprised 104 members. The lay element was less than 25 per cent. Doctors chosen by their peers dominated the Council. Such a large Council is on any analysis an unwieldy organisation to govern any profession, and in 2008 the numbers were whittled down to twelve lay members and twelve medical members,⁸⁰ and in 2012 numbers were halved again to six medical and six lay members.⁸¹

So what does the GMC do? The Medical Act lists four principal functions of the GMC:

(1)  to provide advice for doctors on ethics and standards of professional conduct;

(2)  to oversee medical education;

(3)  to maintain a register of qualified doctors, licence doctors and to ‘revalidate’ them; and

(4)  to investigate and (in some form) adjudicate allegations about the fitness to practise of doctors.

Advisory function

1.10 First, the Council is charged with providing advice for doctors on ethics and standards of professional conduct, standards of professional performance and medical ethics.⁸² Reference to this advice is made throughout this book. The core guidance is contained in Good Medical Practice, which was first produced in 1995 and was comprehensively revised in 2006. The 2006 version emphasised the importance of partnership between doctors and patients, and placed new weight on equality and diversity. Most importantly, it clarified the standard of professional conduct that underpins the GMC’s fitness-to-practise procedures. The aim was to achieve greater certainty and consistency in both patient expectations and doctors’ professional standards. In 2013, the guidance was updated and restructured around the four domains used to appraise doctors undergoing revalidation. Good Medical Practice (2013) is accompanied by a series of explanatory guides,⁸³ interactive case studies and learning materials.⁸⁴

Medical education

1.11 Second, the Council sets standards and outcomes for medical education.⁸⁵ In the past the GMC was responsible for undergraduate medical training and the first year of foundation training. The Postgraduate Medical and Education Training Board (PMETB) looked after the second year of foundation training and specialty training.

Following the Tooke report,⁸⁶ a merger took place in 2010⁸⁷ and the GMC became the sole regulator of medical education throughout the different stages of training. The PMETB was abolished in April 2010 and the GMC created three boards: the Undergraduate Board; Postgraduate Board and Continued Practice Board. A new independent body, NHS Medical Education England, provided guidance on education and training.

The Health and Social Care Act 2012 replaced NHS Medical Education England with a new Special Health Authority; Health Education England (HEE).⁸⁸ An accompanying Education Outcomes Framework⁸⁹ forges stronger links between medical education and healthcare outcomes. HEE holds to account thirteen Local Education and Training Boards (LETBs), which are set up to plan locally responsive training. HEE works alongside the GMC, which sets and upholds standards by approving and monitoring curricula and assessments. The Care Act 2014 reconstituted HEE as a non-departmental public body from April 2015, putting it on a firm statutory footing and clarifying duties and powers.⁹⁰

Requirements for undergraduate training are set out in Tomorrow’s Doctors.⁹¹ On completion of the medical degree, section 10A of the Medical Act 1983 requires that provisionally registered, newly qualified doctors receive two years of foundation training to bridge the gap between medical school and specialist or GP training.⁹² At the end of Foundation 1 (F1), full registration and a licence to practise is dependent upon demonstration of outcomes set by the GMC’s Education Committee. Year F2 is the doctor’s first year as a fully registered, licensed doctor. At the end of the F2 year, doctors compete for training in their chosen speciality or GP training. The Joint Royal Colleges of Physicians Training Board (JRCPTB) sets specific standards of specialist training to complement the GMC’s generic standards. Trainees are required to register with the JRCPTB so that their progress can be reviewed and they can be awarded a Certificate of Completion of Training (CCT). The CCT confirms that the doctor has completed his training and can be entered onto the GP Register or the Specialist Register.

In the case of BAPIO,⁹³ the British Association of Physicians of Indian Origin challenged by way of judicial review the Clinical Skills Assessment (CSA); an exit exam for trainee general practitioners. The failure rate is significantly higher for foreign graduates. It was alleged that the differences in outcome resulted from discrimination against South Asian and BME (black and minority ethnic community) doctors. The claim was raised against the Royal College of General Practitioners (as assessor) and the GMC (as regulator). Mitting J dismissed the claim: there was no breach of the Equality Act 2010 and the requirement to pass the CSA had not been unlawfully racially discriminatory. The stringent requirements are considered essential to protect patient safety. But an anomaly in the pass rates is made clear in the BAPIO case.⁹⁴ The importance of diversity of the medical profession and the significant contribution of international medical graduates to the NHS cannot be overstated.

Maintaining a register

1.12 Third, the GMC is charged with the maintenance of the ‘list of registered medical practitioners’ and provides licences to practise. Doctors listed on the medical register have full, provisional,⁹⁵ specialist or GP registration.⁹⁶ All are accessible online. The GP register is a list of GPs eligible to work in the UK. It provides information for patients and aids pre-employment checks. The Specialist Register identifies medical practitioners by their specialties, accreditation and qualifications. Equivalent qualifications from other Member States of the EU must be recognised by the Joint Royal Colleges of Physicians Training Board.⁹⁷

The GMC assess the language skills and clinical competence of doctors coming from outside the EU,⁹⁸ but were restricted in relation to EU doctors. The GMC sought a change in the rules after a German doctor, Daniel Ubani, on his first shift as an out-of-hours GP, prescribed a fatal dose of morphine to a pensioner in 2010.⁹⁹ At a fitness-to-practise hearing, Dr Ubani was struck from the register. The Medical Act 1983 was amended in 2014, to allow the Council to refuse a licence to practise when a medical practitioner from the EU has insufficient English language skills. The 2014 Order also introduced a new fitness-to-practise category of impairment due to language incompetence.¹⁰⁰ From 2014 the GMC raised the score on the International English Language Testing System required of both international and EU doctors.

Registration alone used to be sufficient to permit a doctor to practise medicine and hold herself out as a medical practitioner. Amendments to the Medical Act¹⁰¹ additionally require that doctors hold a licence to practise.¹⁰² The licence is granted by the GMC at registration and is required of any doctor, private or NHS, part-time or full-time, if they wish to work in the NHS, write prescriptions or sign death certificates.

Doctors need to show that their fitness to practise is not impaired at the point of registration and licensing with the GMC. Failure to declare relevant factors could lead to the doctor being struck from the register and losing his licence to practise. Doctors are also required to carry professional indemnity or insurance cover from the point of registration and failure to do so could amount to impaired fitness to practise. Since 2010, doctors can appeal against decisions to withdraw or refuse registration or a licence to practice under Schedule 3A of the Medical Act 1983.¹⁰³

Revalidation

1.13 Licensing was the first step towards ‘revalidation’ whereby doctors are appraised to ensure their general fitness to practise and compliance with Good Practice guidance. It was envisaged that revalidation would be introduced as early as 2005,¹⁰⁴ but the 5th Report of the Shipman Inquiry highlighted a number of serious concerns.¹⁰⁵ The CMO recommended a more rigorous scheme of revalidation¹⁰⁶ involving separate evaluations for re-licensing and recertification. But this complex system was dropped in favour of simpler and streamlined revalidation introduced, at last, in 2012.¹⁰⁷

Revalidation forms a continuous assessment based largely on local systems of annual appraisal. Doctors form a connection to a single organisation (their ‘designated body’) each of which appoints a senior doctor (a ‘responsible officer’) to oversee the governance systems and appraisals. At annual appraisals, doctors present a portfolio of supporting information. Every five years, all doctors licensed to practise in the UK must show that they are up to date and fit to practise. This is judged according to an Appraisals Framework¹⁰⁸ based on the GMC’s Good Medical Practice guidance.

How has revalidation been received? Responsible officers and appraisers are supportive, ‘but this is not yet shared universally among doctors: some of whom feel that the system is not relevant to their needs’.¹⁰⁹ The GMC points to a positive change in culture and practice¹¹⁰ flowing from the proactive nature of revalidation.

Disciplining doctors – fitness to practise

1.14 The doctor’s employer, like any other employer, may initiate disciplinary proceedings and as a result a doctor may face suspension or dismissal.¹¹¹ The courts will not micro-manage NHS employers, but have proved willing to grant injunctive relief where there is evidence of irregularities.¹¹² The disciplinary procedures are complex¹¹³ and will not be dealt with in any detail here. However, note that being sacked from an NHS hospital will not of itself stop the errant or incompetent doctor practising medicine. She may simply move to the private sector. Only the GMC can act to ensure that an ‘unsafe’ doctor can no longer practise.

Complaints about doctors – whether they emanate from patients, other doctors or their organisations – can thus be put to the GMC, which may then investigate whether or not the doctor is fit to practise.¹¹⁴ Once a complaint reaches the GMC, there are two stages to the fitness-to-practise process – investigation and adjudication. Until recently, the GMC was responsible for both stages. The dual role of prosecutor and adjudicator resulted in a loss of public confidence. Following three public consultations¹¹⁵ a new independent tribunal service was launched in 2012. The GMC investigates, while the Medical Practitioners Tribunal Service (MPTS) chaired by a judge adjudicates. In 2015, the MPTS was put on a statutory footing, further enhancing its independent status.¹¹⁶

Fitness-to-practise proceedings have been subject to several reforms. In 2004 three separate streams of health, performance and conduct were abandoned and complaints about doctors were analysed ‘in the round’.¹¹⁷ Further reforms in 2009, 2013 and 2014¹¹⁸ have been consolidated in a guide published by the GMC in 2014.¹¹⁹ The focus is now on whether the doctor’s fitness to practise is ‘impaired’; that is, whether by misconduct, health or other stated cause, the doctor can be considered unable to practise safely and effectively. In reaching a conclusion, regard must be had to the overarching objective of public protection, which incorporates the obligation to promote a safe NHS in which there is public confidence.¹²⁰

Under section 35C(2) of the Medical Act 1983, as amended, impairment can result from all or any of the following:

(1)  misconduct;

(2)  deficient performance;

(3)  a criminal conviction or caution in the British Isles (or elsewhere for an offence which would be a criminal offence if committed in England or Wales);

(4)  adverse physical or mental health;

(5)  a determination by a regulatory body either in the British Isles or overseas; or

(6)  not having the necessary knowledge of English.¹²¹

At the investigation stage, the case examiners (one medical and one lay) can refer the doctor to an Interim Orders Panel where there is a clear need to protect patients or the public interest.¹²² The panel has the power to impose an interim order restricting or suspending the doctor’s right to practise pending the full investigation.¹²³ Where the public interest is not threatened, a single test which emphasises the GMC’s duty to the public¹²⁴ is applied to determine whether a doctor should be referred to a fitness-to-practise panel for a full hearing:

In exercising their discretion, the Committee or the case examiners must have in mind the GMC’s duty to act in the public interest, which includes the protection of patients and maintaining public confidence in the profession in considering whether there is a realistic prospect of establishing that a doctor’s fitness to practise is impaired to a degree justifying action on registration.¹²⁵

At this stage the GMC may conclude the case, agree undertakings with the doctor or issue a warning;¹²⁶ a measure introduced for cases which call for an official response, but which are not serious enough to justify restrictions on the doctor’s registration, when either ‘there has been a significant departure from Good Medical Practice’ or ‘a performance assessment has indicated a significant cause for concern’. Alternatively, the GMC can refer the case to the MPTS for a fitness-to-practise panel hearing. The Manchester-based MPTS is operationally separate to the GMC. In its first year of operation it heard over 350 cases.¹²⁷

There are three stages to the hearing: the finding of facts; the decision on impairment; and the decision on sanction. At the first stage, the Tribunal considers whether there is sufficient evidence of the facts alleged. In some cases, the facts will be disputed. The burden of proof rests with the GMC, which makes the allegations. The Health Act 1999 (as amended) replaces the criminal standard of proof (which was thought to be inappropriate and potentially too lenient on doctors) with a civil standard.¹²⁸ Doctors are now judged on the balance of probabilities rather than establishing proof ‘beyond reasonable doubt’. The civil standard is a sliding standard that can be flexibly applied.¹²⁹ The more serious the matter, the greater the degree of probability required.

At the second stage, a decision on impairment is made. The Tribunal asks whether, on the basis of the facts, fitness to practise is impaired. If the answer is ‘no’, then, in common with the investigation stage, a warning can be issued,¹³⁰ or no further action taken. If the answer is ‘yes’, then the Tribunal proceeds to stage three and in camera makes a decision on sanction. There are four options:

(1)  undertakings;

(2)  conditions (maximum 3 years);

(3)  suspension (maximum 1 year); and

(4)  erasure from the register.¹³¹

New rules to speed up the process and reduce the stress for those involved were introduced in 2013. There is no longer a requirement to read out the written allegations at the start of a hearing and witnesses can submit evidence remotely.

Appeals to the High Court and the Professional Standards Authority

1.15 Doctors have two routes to appeal. If they have received a warning, they can seek judicial review. If the MPTS panel has found that the doctor’s fitness to practise is impaired, the doctor has twenty-eight days to appeal to the High Court under section 40 of the Medical Act 1983.

The court will decide if the decision of the fitness-to-practise panel was ‘wrong’.¹³² For example, the panel may have acted improperly or the sanction might be disproportionate. In the latter case the court is entitled to prioritise the public interest – in particular public confidence and the standing of the profession.¹³³ The court has a range of powers. It can dismiss the appeal, quash, amend or substitute the direction, or remit the case back to the GMC fitness-to-practise panel.¹³⁴

In 2010, Professor Walker-Smith and Dr Wakefield’s names were erased from the register following a finding of serious professional misconduct. They were both involved in a paediatric clinical trial, following which Dr Wakefield publicly made the link between the triple ‘measles, mumps and rubella’ (MMR) vaccination and autism, while Professor Walker-Smith made clear his support for the governmental policy on MMR. Dr Wakefield abandoned his appeal, but in 2012 Professor Walker-Smith’s registration was restored after a successful appeal.¹³⁵ The panel had made errors and applied ‘inadequate and superficial reasoning’. The GMC accepted the decision and has subsequently made changes to its fitness-to-practise procedures as outlined above.

Doctors can appeal if they feel they have been dealt with harshly.¹³⁶ So too the Professional Standards Authority for Health and Social Care (PSA)¹³⁷ may appeal to the High Court under section 29 of the National Health Service Reform and Health Care Professions Act 2002, where it considers a decision to be unduly lenient. Alternative dispute resolution reduces the number of cases that make it to court. The PSA appealed one (out of 397 GMC cases reviewed) in 2012 and two (out of 219 cases reviewed) in 2013.¹³⁸ In 2013, the PSA announced that it would challenge the finding that a chief nurse who worked at Stafford Hospital between 1998 and 2006 was unduly lenient. Ms Harry was initially given a five-year caution by the Nursing and Midwifery Council for her role in the hospital crisis. In 2014, legal agreement was reached and she was struck from the register.¹³⁹

Section 29 orders have caused disquiet on the basis that the criteria for determining undue leniency include the ‘maintenance of public confidence in regulation’ which might potentially go beyond the merits of the case.¹⁴⁰ In 2004, the Court of Appeal clarified the PSA’s (formally the Council for Healthcare Regulatory Excellence) powers.¹⁴¹ Not only may it refer cases to the High Court when it is of the view that regulators have acted too leniently in applying ‘penalties’, but it may also do so when the regulator acquits a healthcare professional. Thus, even if a doctor is acquitted by the GMC, the PSA may refer her to the High Court, which can impose a sanction. Mason and Laurie point out that the element of double jeopardy such doctors are subjected to has potential to offend their rights under Article 6 of the European Convention of Human Rights.¹⁴² In 2014 the double jeopardy argument was raised by a psychiatrist who was found not guilty of misconduct in relation to an online advice blog he ran.¹⁴³ The GMC found the doctor’s advice deficient, but did not consider that the blog amounted to ‘medical practice’. The PSA appealed the decision, arguing that it was too lenient and their view was accepted by the GMC. The psychiatrist raised the issue of double jeopardy, but the appeal was nonetheless allowed on the basis that it was not unlawful double jeopardy. In a 2015 referral to the High Court on the issue of leniency, Lang J stated: ‘[R]eference to having regard to double jeopardy when considering whether a sentence is unduly lenient is not … really apposite where the primary concern is for the protection of the public’.¹⁴⁴

Regulating the NHS

1.16 The first part of this chapter examined the regulation of individual doctors. We now turn to methods by which NHS organisations are regulated. In 2012 the Health Committee referred to the regulatory landscape as ‘cluttered and opaque’. Attempts to streamline and simplify such a complex body as the NHS continue to challenge the reformers.

Supervising, managing and protecting employees

1.17 Individual doctors face sanctions when they fall short of good medical practice. But what of the employing organisation? Poor treatment often has several causes. Poor doctors are created by poor systems. In 2000, a 31-year-old father was admitted to hospital for minor knee surgery. The operation was a success, but he went on to develop an infection which resulted in toxic shock syndrome from which, tragically, he died. Doctors Misra and Srivastava had failed to diagnose the infection and were convicted of gross negligence manslaughter in 2003,¹⁴⁵ and suspended from the medical register by the GMC in 2005. In 2006, Southampton University Hospital NHS Trust became the first NHS Trust to be prosecuted under the Health and Safety at Work Act 1974 for failing to manage the two junior doctors adequately. The Trust pleaded guilty to a charge of improper supervision and was fined £100,000 and ordered to pay £10,000 costs.¹⁴⁶

The Corporate Manslaughter and Corporate Homicide Act 2007,¹⁴⁷ while not creating any new duties, may improve accountability of companies and organisations, including healthcare businesses,¹⁴⁸ for fatalities that result from system failures. Penalties include fines, publicity orders (whereby the organisation must publicise its prosecution) and remedial orders (where the organisation must take steps to ensure the mistake will not be repeated).¹⁴⁹ Furthermore, the Criminal Justice and Courts Act 2015 creates new offences of ill-treatment or wilful neglect. Individual care workers can be held so liable under section 20 and the organisation as a whole can be considered to be guilty of the offence under section 21.¹⁵⁰

Organisations must safeguard their patients, but also have a duty to protect their employees. Work-related stress among NHS staff is widespread.¹⁵¹ Long working hours exacerbated the problem. The European Working Time Directive¹⁵² imposed a 48-hour week, but this puts pressures on the finite resources of the NHS. More doctors are needed to fill the rotas; there are more time-consuming handovers to make at the end of a shift; and there is less time for training. The problem was aggravated by the European Court of Justice (ECJ) rulings in SiMAP¹⁵³ and Jaeger:¹⁵⁴ on-call staff, resident at work out-of-hours, are considered to be ‘working’ while on duty, whether or not they are called to the bedside. In 2010, NHS Medical Education England reviewed the effects of the Directive on medical training, concluding that the problems are worst when the trainee doctor is involved in emergency care or has a significant ‘out of hours’ workload.¹⁵⁵ In 2014 an independent taskforce chaired by Professor Norman Williams, President of the Royal College of Surgeons, made several recommendations designed to tackle the current lack of flexibility.¹⁵⁶ One is to protect education and training time and another is to consider encouraging wider use of the right to opt out of the restricted hours.¹⁵⁷ The former method may gain support after a July 2015 judgment of the ECJ. The Commission alleged that Ireland’s standard contract for junior doctors was in breach of the Directive. Ireland argued that training time during which doctors are not required to be physically present for the purpose of providing care does not constitute working time. In a judgment that will surprise many, the ECJ dismissed the Commission’s claim for lack of evidence.¹⁵⁸ Meanwhile, the European Commission launched a public consultation on the Directive in 2014 and is likely to form proposals for further consultation in 2016.¹⁵⁹

Governance

1.18 NHS organisations are responsible for a rigorous system of clinical governance, the central aim being to ensure continuous quality improvement and consistency between organisations. A formal requirement for clinical audit in the NHS was first introduced in 1989.¹⁶⁰ Since that time there has been a bewildering array of reforms designed to enhance and monitor quality in the NHS.

Historically, the Commission for Health Improvement issued ‘star ratings’ to providers from 2003. This body was replaced with the Commission for Health-care Audit and Inspection (the ‘Healthcare Commission’) in 2004¹⁶¹ which abandoned the star ratings in favour of an ‘annual health check’. The Health and Social Care Act 2008 established the independent Care Quality Commission (CQC) which, in April 2009, took over the regulation of both health and social care, in NHS, private and voluntary organisations.¹⁶² From April 2010 all providers of adult healthcare were required to register with the CQC.¹⁶³ GPs and other primary medical services were required to register by 2013. Registration is dependent upon demonstration that the provider reaches outcomebased standards.¹⁶⁴ The registration status of Trusts is published on the CQC website. Monitoring is achieved through audit, annual quality accounts¹⁶⁵ and scheduled, responsive and themed visits. Failure leads to sanctions.¹⁶⁶

The CQC monitors, inspects and regulates health and care providers but it is not the only regulator of providers in the NHS. The NHS Trust Development Authority, a Special Health Authority, is responsible for NHS Trusts’ performance management (including governance and clinical quality) and Monitor – an executive non-departmental public body – regulates health services. Monitor was set up under the Health and Social Care (Community Health and Standards) Act 2003 to authorise and monitor Foundation Trusts. Its role was considerably expanded following the Health and Social Care Act 2012. From April 2014, Monitor assumed responsibility (in conjunction with NHS England), for the system that reimburses providers of NHS-funded care, setting prices, promoting competition and limiting anti-competitive practices.¹⁶⁷

Subject to exemptions, providers of NHS services require a licence.¹⁶⁸ New providers apply for the Monitor licence and CQC registration through a single process. If the conditions of a licence are flouted, Monitor can impose fines or revoke the licence. Monitor, however, is responsible for providing continuity of services and so the emphasis is firmly on resolving the situation. For example, though Monitor acknowledged in 2014 that ‘with the benefit of hindsight it was a mistake to grant the trust foundation status [in 2008]’,¹⁶⁹ it did not withdraw the troubled Mid Staffordshire NHS Foundation Trust’s licence. A special administrator appointed by Monitor recommended that the Trust be dissolved and the services taken over by other