Chapter contents

Introduction

Health Service Policy

Organisational Change

Finance

Quality

Medical progress

General Practice and primary care

Hospital_services

Medical_Education_and_Staffing

Nursing

Chronology

Introduction

"When the NHS celebrated its 50th anniversary with much pomp, commemorative stamps, and a service in Westminster Abbey, a new Labour government was busy reversing many of the policies of its Conservative predecessor. The internal market was abolished, as was general practitioner fundholding. The NHS would indeed be modernised, but it would be on the basis of cooperation not competition.

Who then - in the euphoria of the celebrations when Frank Dobson, the secretary of state for health, could claim that "the NHS remains the envy of the world" - would have anticipated that within a couple of years policy would go into reverse gear? Who then would have predicted the emergence of a new model for the NHS based on choice, competition, payment by results, and a plurality of providers, let alone the emergence of institutions like foundation trusts?"  Rudolf Klein

Editorial, British Medical Journal, 5 July 2008  BMJ 2008;337:a549

Changes in British Society

The economy was sound for most of the decade only to crash at its end.  The UK, like many other countries experienced terrorism, often fuelled by radical Islamic influences.  The devastation in New York 9/11, atrocities in Spain and the London Underground, and the Iraq war cast long shadows. Following the Kyoto Protocol in 1997, climate change and carbon emissions became an international issue affecting policies on energy and transportation.  A further hesitant step forward was taken in Bali in 2007. Globalization, the pressures of the European Community and the digital revolution were driving change. The introduction of the Euro in 1999 fuelled the debate on our place in Europe and a European constitution. To bring Britain in line with the Community ambulances changed colour from white to an eye catching yellow. 

Population movement increased. First London and then the whole country experienced an influx from the European Union.  Tens of thousands of young French came.  Even before the EC expanded many workers from Eastern Europe and especially Poland arrived, filling jobs that the indigenous population did not want. Local authorities complained of the pressure on their services from an increase in the local population.  Retired English travelled to France and Spain for the quality of life. Emigration from the UK increased steadily to nearly 200,000 in 2006. Public reaction to economic migration and asylum seekers changed the political landscape throughout Europe. Some migrants came from areas with a high prevalence of AIDS, tuberculosis and hepatitis B.   While Bevan had explicitly accepted that the NHS should be available to everyone, resident or visitor, government now took the view that it was not intended to be available free of charge to those who did not live in the UK. Government tightened regulations.  Front line staff had little time or inclination to ask their patients too many questions.

["How do we distinguish a visitor from anybody else? Are British citizens to carry means of identification everywhere to prove that they are not visitors? For if the sheep are to be separated from the goats both must be classified. What began as an attempt to keep the Health Service for ourselves would end by being a nuisance to everybody. Happily, this is one of those occasions when generosity and convenience march " (In Place of Fear, Bevan, 1952)]

The World Health Organization's twenty-year plan to bring ‘health care to all’ failed.  Famine, flood, civil war and genocide offset the efforts of aid agencies.   More than 2 billion people had no basic sanitation. The European Region’s Health for All, equally ambitious, was in tatters. (Moore W. The impossible dream. Health Service Journal 2000: 6 January: 8-9.)  The campaign for the reduction of third world debt made only limited progress, and poverty, famine, wars and the AIDS crisis seemed worse day by day. 

Within England the north/south divide seemed to be increasing.  The need  to commit 24/7 to one's employer stressed some.  Crises hit agriculture (BSE, foot and mouth disease) and the provision of rural services became a political issue.  In the urban areas our multi-ethnic society was increasingly apparent.   Racially motivated riots (Oldham), protests against a global economy and violence in the streets, sometimes black on black and even against NHS staff, soured the atmosphere. The fashion for body-piercing and cropped tops changed the townscape while pressure led to the establishment of  smoke free public places. To the profit of pharmacies, a gullible public spent increasingly on ineffective "alternative" medicines, while a split in the anti-vivisection movement led to the use of violence and terror tactics. For the young, adventure holidays and gap years proliferated, with a rising use of recreational drugs and clubbing. Institutional and financial malpractice, threats to the pension schemes and banks (Northern Rock) created a cloud on the horizon.

In 1998 Labour devolved power to an elected Parliament in Scotland, an elected assembly in Wales and an elected assembly in Northern Ireland. Four different health services emerged.  In England there was an accent on improving performance and setting targets, in Scotland a professionally led integrated system based on clinical networks, in Wales, partnership between the NHS and local authorities.  Both in Scotland and Wales benefits were provided that were not available in England, for example in the care for the elderly, drug availability and in prescription charges. The differences in funding under the Barnett formula were apparent, and the differences in spending on the NHS reflected the variation.

The NHS and the Labour Government

Throughout the sixth decade Labour was in power yet the private sector was involved in NHS provision as never before.  Long waiting times for outpatient and inpatient treatment were replaced as problems of concern by the perception that there was poor access to the family doctor service and hospital infection was out of control. In basic research the early steps in nanotechnology, stem cell research and  genetic medicine were taking place and supplemented rapid advance in pharmaceuticals and the technology of imaging.  Patient expectations continued to rise.  Each expensive new technology raised costs and increased demand as treatment became more effective and less traumatic.  Government faced the dilemma of reconciling national standards because of parliamentary accountability with the need to decentralise decision making.  Labour attempted to deal with the obvious defects of the NHS, too few doctors and nurses, poor buildings, and waiting lists.. 

Towards a new model of NHS

In 1999 Frank Dobson told the NHS to adopt a single Logo to imply focus and a consistency of service.  It was soon hard to remember the days when this did not greet one daily.  Yet the nature of the NHS was about to change radically.

New initiatives and new policies altered the NHS substantially, as health advisors in No 10 and economists and operational research staff played a substantial role in shaping policies.  Virginia Bottomley had expressed the idea, increasingly accepted, that the NHS though tax funded and largely free at the point of use, was provided by a variety of organisations.  No longer was it a service where provision was in the public sector facilities owned by the NHS.  It moved from a system in which providers took no risk and patients just waited until they were treated, to one where the search for efficiency spurred a new series of incentives. 

The NHS now provided access to care

• contacting NHS Direct or NHS Direct Online

• going to a local hospital accident and emergency department for triage

• booking an appointment with the GP who provided acute care, care for chronic conditions and health promotion

Each of route of access might lead into the local system.  The local hospital might be

• a university-type hospital with a wide range of specialist units or

• a district general hospital covering most normal requirements but part of a clinical network involving hospitals with more specialised facilities

• as patient choice and "choose and book" systems were expanded, the hospital might be in the private sector

In addition, more specialised services would be based on other specialised hospitals that could provide skills and experience that was not normally available

A raft of policies emerged; private sector involvement, quality, peer review, central direction, performance reporting, accountability, competition, trusts, patient choice, and payment by results.. ^{Dixon J. Editorial, BMJ 2008,336; 844-5}.  There was bipartisan support for many policies such as NICE, a purchaser/provider split, foundation trusts, concentration on long term illnesses, patient choice, involving primary care in commissioning, a tariff system to pay providers and a more personal service.

American concepts were adopted. as Labour, like the Conservatives, looked at what could be learned from managed care organisations in the USA such as Kaiser Permanente. Characteristics of Kaiser included integration of funding with provision of service, integration of inpatient care with outpatient care and prevention, focus on minimizing hospital stays by emphasizing prevention, early and swift interventions based on agreed protocols, and highly coordinated services outside the hospital, teaching patients how to care for themselves, emphasis on skilled nursing, and the patients' ability to leave for another system if care is unsatisfactory.  Kaiser did NOT have a purchaser/provider split.

Governance remained a significant issue - in each decade there are concepts affecting the organisational pattern of the NHS.  In the seventies it was consensus management.  In the eighties the general management function.  Now, spurred by scandals in the financial sector and industry, good governance became a guiding principle. In 1992 the Cadbury Report had identified principles of good governance in organisations - integrity, openness and accountability.  This was taken further in the Nolan Report (1997).  These principles were absorbed into NHS management.

The private sector and the NHS.

As the NHS moved from a services provider to a commissioning led organisation the opportunities grew.. The increasing involvement was opposed by Frank Dobson, substantial parts of the Labour Party, unions, NHS management and sometimes the medical profession.  Payment by Results (PbR) and independent sector treatment hospitals opened a more sophisticated and aggressive internal market than the Conservatives had tried in the 1990s. Previously the NHS used the private sector largely as a pressure release valve, often at high cost to handle an immediate problem.  Now it was becoming integral to all segments of the NHS.

• In primary care commercial organisations tendered to provide family practitioner services

• Hospital trusts increasingly contracted out services.  Patients might have a choice of a private hospital for NHS care. The private finance initiative was funding hospital building and privately managed independent treatment centres handled NHS patients.  At Lymington a new consultant led community hospital with beds was managed by a private sector company, Partnership Health Group.  Conversely UCLH contracted its 15th floor to an American healthcare organisation, collecting both rent and payment for imaging and other services

• The Department of Health opened the purchasing/commissioning of care to the private sector in 2006. A privately owned manager, under contract to the PCT, might be charged with obtaining best value for money

• The supply of equipment to the NHS, sometimes directly purchased by NHS Trusts locally, but often supplied by NHS Logistics, became the responsibility of a new NHS Business Services Authority, and the NHS Supply Chain was outsourced to DHL, which took over staff, depots and used the NHS Logo

Private patients

The UK spends less than almost any other Western country on private health care, although about 15% of its total health spending involved the private sector. The number of those in the UK with private medical insurance had remained static for several years but increased again in 1998 to 3.5 million and in 2000 to 5 million, about 12.6% of the population.  More were insured in the south than the north, and the growth in the numbers was even larger among those paying for private treatment out of their own pocket, sometimes on fixed cost 'pay-as you go' packages provided by private hospitals.  Some 13 million people appeared to use the private sector.  Cataract removal for £2000, knee replacement for £7,000 or a heart bypass for £10,000 might be a practical proposition.  Major providers of private facilities included BMI Healthcare, BUPA and the Nuffield Hospitals.  About 850,000 operations a year were carried out in the private sector, in some 200 hospitals, two-thirds of the beds being owned by major groups.

Ethics and Patient participation

Ethical problems abounded, particularly in the fields of genetic medicine and in vitro fertilisation. In 2008 Parliament considered  the possibilities now opening, for example in the creation of 'rescue babies' whose stem cells could help a sibling.  People increasingly wished to be consulted on their care, and could turn to Internet.  The GMC sent doctors advice on the importance of consent and the ethical problems that might arise.  The Council stated in 2008 that doctors must be prepared to set aside their religious and other personal beliefs if these compromised the care of patients, instancing face veils worn by a  doctor if that was an obstacle to communication and trust, abortion or cremation.

In a consumer society people expected more and Labour attempted to increase people's participation in their individual care and in the management of the NHS.  Community Health Councils were replaced by a Commission for Patient and Public Involvement in Health in 2003, abolished in 2008 and replaced by a new system, LINKs.  The encouragement to join foundation trusts as members was a further approach.

Internet

The rapid spread of the Internet was becoming a powerful way of creating a patient-led health system. In 1998, 6 million in the UK had access to the web at home or at work and within the decade the majority had broadband access.   People might make direct contact with doctors via health web sites (c.f. www.drgreene.com). Facebook (2004) Blogs and YouTube.  The clinical knowledge on the web was so vast that doctors, faced by a difficult diagnosis and an unaccustomed group of symptoms, might find useful suggestions by using Google.

The US Government, the Mayo Clinic and Kaiser Permanente were early as in the field.  The UK government was initially cautious but by 2000 the NHS, the Department of Health and the British Medical Association had effective sites and increasingly used them to publish their documents and reports.  Sometimes the only way to find out about the role of the many new organisations in health care was to look at their web site. The NHS website was re-launched as NHS Choices in June 2007 to provide patients, carers and the public with accurate and up-to-date health information.  Initially managed by Dr Foster, Capital became the preferred bidder in June 2008.

Education also benefited. A National Electronic Health Library was developed as a resource primarily for professionals, to be followed by the National Library for Health.  In 1998 the BMJ became an open access journal, making  the full text  freely available.  In 2003 the BMJ Publishing Group provided access to the evidence-based summaries available in Clinical  Evidence and NHS Direct linked to this material. Journals increasingly offered on-line editions, sometimes free, and Stanford University's Hire-Wire Press hosted several hundred electronic versions of scientific journals and provided a search system. U.S. National Library of Medicine's free digital archive of biomedical and life sciences journal literature (PubMed Central (PMC)) aimed to digitise a complete archive of medical journals, including the BMJ, some going back more than 125 years.

Health service information systems

An effective NHS information system centred on clinical need was at last under development. There had long been grounds for concern about the accuracy of information.  In 2002 the Audit Commission was still concerned in its report Data Remember: Improving the quality of patient-based information in the NHS. Appropriate technology was at last becoming available.  The assessment of the quality of care, and contracts that required information about who had done what for whom, increased the importance of IT.  Finally, new services such as pharmacist prescribing and walk-in centres made a coherent IT system essential. An NHS Information Authority was established to manage the development of national health information systems.  It oversaw the introduction of the NHS number, new numbers for babies, payments for GPs and national screening programmes.  It was later phased out to be replaced by the NHS Connecting for Health and the Health and Social Care Information Centre (2005).

The strategy for NHS IT dated back to 1992.  However the problems that had been experienced  reduced support for the programm.  In 1998 a white paper,  Information for Health, created new momentum and shifted the emphasis to the clinical from the administrative.  It committed the NHS to provide life-long electronic health records for everyone with round-the-clock, on-line access to patient records and information about best clinical practice for all NHS clinicians.  Every GPs would be connected by 2000, but targets were missed.

Further impetus followed a  seminar in Downing Street in February 2002 and the Wanless Report in April 2002 which criticised NHS IT as piecemeal and poorly integrated. In July 2002   Delivering 21st century IT support for the NHS was published. An unprecedented investment in IT began, which would cost some £18 billion over ten years (though early estimates were far smaller).  It was the world's largest and most ambitious health programme, creating comprehensive electronic health records compiled at the point of care, and to be made available to users in primary, secondary, tertiary and community care.

A National Director was appointed in October 2002, Richard Granger.  Contracts stressed speed, competition and payment to contractors only if they delivered.  In 2004, following a review of Arms Length Bodies, the Department created a new body with the responsibility for the delivery of the programme and the management of IT functions and in April 2005 the programme was renamed NHS Connecting for Health. The programme was handled in a top down fashion to overcome the previous piece-meal approach. The service was organized in two parts, a national spine and five local service providers that aggregated the health service into five regional clusters. In 2004 BT was awarded the contract to provide the national infrastructure (National Application Service Providers [NASPs] ), as well as the contract to be one of four Local Service Providers (LSPs) responsible for local level services.  Three other firms won contracts to provide services in four other areas. (see map below).  LSPs were responsible for IT systems and services used locally, such as GP and trust systems. They would also make sure local applications could ‘talk to' and share information with the national systems.

National Application Service Provider contracts were also awarded to BT for the NHS Care Records Service, Atos Origin (formerly SchlumbergerSema) for Choose and Book (The Electronic Booking Service), BT for N3 (the New National Network). BT would act as a system integrator, and BT Syntegra for new software to manage information and payments under the Quality and Outcomes Framework.  The system involved

• A national network for the NHS - fast connections to all NHS sites (NHS Net was renamed N3)

• An Electronic referral service - Choose and Book, so patients could choose which hospital they would like to attend at a time to suit them, exercising choice at the point of referral.  In October 2003 a £60 million contract was signed to provide the system.  The programme fell two years and there were problems over confidentiality.  However by 2007-8 the system became increasingly reliable and it became important in meeting the 18 week target from referral to treatment.

• NHS Care Records Service (NHS CRS) containing basic patient information and health details. Eventually people would be able to access their record and all their health information, and be more involved in making decisions about their own care and treatment.  GPs were anxious because the main system in use in their surgeries was not adopted by the new national groupings. This application fell grossly behind schedule.
  

By 2006 the programme was behind schedule, sometimes by years.  Many hospitals had to upgrade ageing systems as the long term solution was not in sight.  GPs could continue to choose one of a wide range of existing systems, rather than being forced onto a national standard that was not available.  Contracted suppliers were facing facing major losses and in 2006 Accenture gave up a £1.9 billion contract, passing it to CSC amid fears of further delays. Public anxiety about the security of personal information was increased by a series of security breaches, including the loss in 2007 by government of 25 million personal records relating to child benefit. In 2008 Fujitsu withdrew from the contract from the south of England.  Richard Granger left the programme in 2007.  By then the NHS spine was in place, ensuring that basic data, name, address and NHS number, were correctly recorded.  The summary medical record and its transmission between providers remained far off.   Electronic appointment booking was making progress, though electronic prescriptions were slow to come on stream. The Department established a review and found failures right at the top, no one seemed to "own" the big picture on information, there was no system to translate policy into business requirements, and a shifting of responsibility for IT around the Department.

Computerisation

In general practice the cooperation of the BMA, the RCGP and government to introduce financial incentives, had led almost all to use computers in their consulting rooms for prescribing and records. By 1996, 96% of general practices were computerised and about 15% now ran "paperless" consultations. In hospitals computing was treated as a management overhead and doctors had few incentives to become involved.  There are several reasons why it was easier to computerize general practices and all are related to scalability. What works for a small practice does not work for a big hospital or across the primary-secondary care divide. For twenty or more years GPs had used PCs; hospitals needed larger machines. The sheer size of the hospital sector and the way in which technological advance rapidly outpaced information technology in the NHS, led to substantial difficulties.  The structure of patient records differs substantially from specialty to specialty, terminology, varying computer standards, security and rapid technological advance all make for problems. ^{(Benson T, BMJ 2002: 325,1066-9 &1090-93)} 

NHS Numbers

In 1995/6 a new NHS number was issued to all patients on GPs' lists.  These numbers formed a database for electronic patient medical records.  The data base was soon used for a  National Strategic Tracing Service (NSTS) to provide the NHS with accurate patient administrative data.  Based on a secure database of all people born, or who had been registered with a GP in England and Wales, by 2001 it provided on-line access to over 60 million records covering all GP registered patients.  It included:

• people (NHS number, names, date of birth, sex, date of death etc)

• places  (address, postcode);

• and organisations  (GP practices, Trusts, Health Authorities) and

• the relationships between them, within the NHS.

John Reid (2003-2005)  Deeply committed to Bevan's vision of a national health service he eased the rapid pace set by Alan Milburn.  He focussed more narrowly on a few key things that might be delivered, e.g. admission waiting times and a four hour target of waiting time in A and E.   At last there were improvements in waiting lists and staffing.  Foundation Hospitals were a divisive issue but Reid continued to develop them. GPs and consultants fought against new contracts and then accepted them gaining far more money than the Department had predicted.  He established a review of the many "arm's length bodies" and continued the 'modernisation' policies of his predecessor and placed increasing emphasis on patient choice. The new market of financial flows (Payment by Results) came into effect and there was increasing emphasis on chronic diseases and long term care. Key documents were Patient Choice, and A patient led NHS : Delivering the NHS improvement plan  

Patricia Hewitt (2005-7) continued these policies with progressive introduction of private sector services, within the framework of a national service with its traditional values (see speech of 19 September 2006.   A systemic change was now under way, moving to a more market based approach e.g. Health reform in England- Update and next steps December 2005] The first major initiative of her own was the publication of a white paper in January 2006 Our Health, Our Care, Our Say - Community Care  January 2006 on a shift of care from hospitals to the community services.  By the 2006 Annual Conference of the BMA doctors made clear their opposition to a whole range of policies,  patient choice, payment by results and practice based commissioning. 

Alan Johnson, (2007-2009)  a former union general secretary appointed by Gordon Brown, took a fresh look at things.  As part of his Government of All Talents (GOATS) Gordon Brown selected a  high-profile surgeon Professor Lord Darzi.  Within days yet another  review of the NHS began to explore "the causes of dissatisfaction among staff and patients". In January 2008 Gordon Brown delivered a speech outlining his view of the future of the NHS and the Review High quality care for all was published in June 2008.  Johnson was particularly committed to the reduction of health inequalities and published a review of the progress and next steps in reducing them.

Policy Developments during the decade

• The New NHS - Modern, Dependable

• The NHS Plan

• The Modernisation Agency

• The NHS Improvement Plan

• Patient Choice

• Community Services

• A new NHS Review and the Darzi Developments

The New NHS - Modern, Dependable

When Labour came to power in 1997 Frank Dobson (and his minister Alan Milburn) found to their dismay that in opposition the party had developed no health service policy ready for implementation.  They were starting from scratch.  In that December Labour issued the The new NHS - Modern, Dependable, which set out their initial vision for change to NHS structure, conceding that some of the features of the Conservatives' internal market were worth keeping.  Labour wished 'to rebuild public confidence in the NHS.'  They built on Conservative initiatives while denouncing them.  The Government wanted to get things done fast and without necessarily relying on local management bodies.  Watch-dogs, systems of audit, targets, and quantified, external and retrospective methods of control proliferated, as did "zones", initiatives and 'czars' with a responsibility for improving specific service.   

There were three main themes of The new NHS all building on current trends

• better communication within the service.
  GP out-of-hours services had increasingly used nurses to assess emergency calls and the new nurse-led help line and NHS Direct  was a dramatic development of this, paralleling the call centres developed in the private sector.  Electronic communication had been developing for twenty years.

• an accent upon quality with new national supervisory bodies. 
  The existing quality initiatives were disparate and it made sense to try to pull them together.  Labour established a National Institute for Clinical Excellence ((to investigate and approve cost-effective pharmaceuticals and interventions for use in the NHS), and a Commission for Health Improvement (later the Healthcare Commission) to see what was in fact happening

• revision of the NHS organizational structure.
  The harder edges of the internal market were softened.  Fundholding would go, co-operation replacing more extreme forms of competition.    ‘Partnership’ and ‘integration’ would replace the internal market .  The jargon changed to that of New Labour; 'seamless services’ became ‘joined-up thinking’. National guidance stressed the interdependence of health and social care, and joint programmes, a return to  the attempts by Barbara Castle and David Owen in 1974 to integrate health and social services planning.  The NHS Act (1998) gave legislative authority for these changes and also the basis of professional self regulation of the General Medical Council.  ^{See  BMJ 1999; 318: 317}

By autumn 1999 it was clear that the NHS needed a lot more money urgently.  A Mori poll showed that public satisfaction with the NHS  fell substantially between 1998 and 2000 from 72% to 58%. Alan Milburn, becoming Secretary of State,  reversed Frank Dobson's policy and encouraged cooperation with the private sector.  Following the Blair/Frost  interview on16 January 2000 (See Finance below)  extra money was found for the NHS in the March 2000 budget on condition that the service and the professions ‘modernised’ themselves.  Burdens on GPs might be reduced by NHS Direct and walk-in clinics; GPs, dentists, opticians, pharmacists and physiotherapists might group to take on more hospital work and old people might move out of big hospitals to convalesce in smaller ones freeing the main hospitals for acute care. 

The extra money - a substantially higher growth rate of some 7-9% - was generous.  In May 2000 the government announced a new plan, issued millions of questionnaires to the public and established six service reviews.  Richard Branson of Virgin Airways was to advise on how to make NHS hospitals more consumer friendly - he concluded that the NHS was being undermined by poor management and abysmal patient care. Labour dumped on chief executives a flood of central initiatives, requests for returns, demands for reassurance, and circulars.  Centralization was in the ascendant.  Yet the NHS could not be allowed total freedom.  Cost and  quality varied widely. Performance indicators had long showed that unit costs varied massively even for straightforward procedures such as appendicectomy (£470 - £2,100 per case). Why?

A seminal analysis had been published the previous year by Professor Alain Enthoven, who had earlier assisted thinking about the NHS in the mid-eighties. Enthoven published an analysis of the results of the 1991 reforms (^{In pursuit of an improving National Health Service:  1999 Rock Carling Fellowship. London: Nuffield Trust, 1999, see also BMJ}).  He saw advantages in the competition and innovation that had been introduced and thought there had been a slight rise in productivity although there had been higher ‘transaction costs’. Fundholding tilted the balance of power from secondary to primary care and in some trusts improvements had resulted from increased locally responsibility for performance. However he thought that the information about costs and quality was often not available, and incentives were sometimes perverse, with patients following the money allocated contractually, instead of money following patients to the hospital where they wished, or needed, to be treated. He argued for far greater attention to continuous quality improvement in the NHS.  Enthoven queried whether Labour could make the NHS more responsive to the public without introducing consumer choice, competition and substantially more money.  He thought more money, fundamental reform and examination of performance variation was required. He cautioned against ‘quick fixes’ and Labour’s tendency to centralize management and policy making. He argued that consumer choice - to which the Conservatives had been moving - was essential.  Labour was listening.

The Plan's aspirations were not costed and in the event the same money was spent on several different things storing up a future crisis. 

• pay awards above inflation and poorly negotiated contracts

• reducing the hours worked by junior doctors

• the recommendations of NICE

• the costs of National Service Frameworks for mental illness, cancer and heart disease

• the costs of establishing Primary Care Trusts

There was an assumption that there would be cash enough, or at the least if government was rough enough with the NHS and its management, aspirations would be somehow be delivered.  Few Trusts had any chance of achieving all the targets and put finance at the top of their priorities.  Chief Executives might be warned that it would be 'personally dangerous' to make a fuss.  The biggest threat to the Plan's objectives was shortage of skilled staff.  In some hospitals the staffing level on wards was at crisis point and patients were not even being washed.  Some thought that the NHS Plan raised expectations to an unsustainable level.  Alan Maynard, professor of health economics at York, said it contained lots of words and good intent, but that the pearls among the manure had to be teased out. Even with enhanced budgets the new agenda could not be afforded. The previous Secretary of State Frank Dobson feared that some failing hospitals might come to be managed by private-sector organisations. David Hunter wrote that the evidence from successive reorganizations since 1974 was that altering the structure and configuration of health agencies invariably resulted in unrealistic expectations for changing the culture of an organisation required stability, costs higher than forecast with a loss of irreplaceable skills and expertise, and failure to save money

Managers were unhappy not because of the government's goals, or its diagnosis of the problems of the NHS, but because of the way policy was implemented, the obsession with organisational restructuring, micro-management, short term demands, 'must do' edicts, and a name and shame culture. 

The changes in the NHS Plan and Shifting the balance of Power (August 2001)  required legislation because of the alterations to the  nature and duties of health authorities.  Patient advisory and liaison services (PALS) would be established to provide assistance to patients, resolving complaints where possible but helping patients when a formal complaint seemed appropriate. In September 2001 the government established a Commission for Patient and Public Involvement in Health.  The impetus owed much to Professor Sir Ian Kennedy who had chaired the Bristol report into heart surgery (2001). The Commission had the responsibility for establishing, funding, staffing and managing a network to take over the function of the Community Health Councils. It was a complex structure and in  2004, under the review of Arms Length Bodies, the Commission's future was questioned.  It was closed in March 2008 to be replaced by  (LINks) coterminous with local authorities.

After the 2002 budget had increased funding,  Alan Milburn, published Delivering the NHS Plan - next steps on investment, next steps on reform.  This  introduced important new ideas

• A change in the pattern of financial flows in the NHS moving to payment by results (PbR) using a  tariff system.  "Health Resource Groups" would establish a standard  tariff on a regional basis for the same treatment regardless of provider.

• Foundation Hospital Trusts would be identified.  They would be established as independent public interest companies, outside Whitehall control, and governed only by performance contracts and inspection by the Healthcare Commission.  They would have greater freedom of decision making.

• Patient choice. Patients would be given information on alternative providers and would be able to switch hospitals to have shorter waits. Patients who had waited more than 6 months would be offered services at an alternative hospital.
  

• Primary Care Trusts would be free to purchase care from the most appropriate provider, public, private or voluntary
  

• A new Commission for Healthcare Audit and Inspection (CHAI - the Healthcare Commission) would be created by legislation, taking over the responsibilities of the Commission for Health Improvement, health audit responsibilities of the Audit Commission and the National Care Standards Commission, a body concerned with the private sector that had only been in operation for three weeks. 

The wheel had turned full circle within a decade and was returning to something like the Conservatives' market reforms.  Alain Enthoven described the plan as a bold wide-open market, more radical than the previous Tory version of an internal market system.  Kenneth Clarke agreed that it was the internal market re-written and oriented to patient choice and devolution.  Clarke's reforms had faced a barrage of criticism from medical organisations; now there was little protest.

Labour had not traditionally favoured choice in public services although in 1948 Bevan had made it possible for people to be treated in any NHS hospital  according to their clinical need. This freedom of choice was constrained a little by the Conservative NHS Reforms and considerably more by the Labour administration of 1997.  Alan Milburn felt patient choice important and the ability of people to chose where they might treated, and how, might improve the system. ^{Mooney H & McLellan A, HSJ 2003, 9 October, 12-3}   In December 2003 the government published a strategy paper “Building on the Best; Choice, Responsiveness and Equity in the NHS” .

Proposals included:

From autumn 2004 patients waiting more than six months for elective surgery were offered the choice of faster treatment in alternative hospitals. Primary Care Trusts established referral management centres, with clinical expertise to assess patient problems, sometimes helping to manage demand so that it stayed within financial limits. The alternative providers were often in the independent sector or new independent treatment centres or trusts with spare capacity.  The NHS Improvement Plan  told  PCTs to offer patients four or five choices and that private/independent care should feature amongst these.  A Patient-led NHS published in March 2005; allowed independent providers such as BUPA to be included on the list of choices. In January 2006 general implementation began, with patient information leaflets and a web site to help people.  Patients might now choose private sector hospitals that many thought were cleaner, better managed, had shorter waiting times and provided better facilities.  But if money followed into private hospitals, there was a substantial threat to the budget of NHS ones.

From April 2008 GPs were able to refer patients to NHS hospitals and some independent treatment sector treatment centres anywhere in England for routine elective treatment.  NHS trusts were able to advertise their services, advertising their waiting times, surgical results and infection rates.  Testimonials and sponsorship from appropriate companies would also be permitted.

• Shifting expenditure from hospitals to the community and preventative services

• Bringing some specialties from the hospital nearer to people, e.g. dermatology, ENT, orthopaedics and gynaecology

• encouraging community hospitals that provide diagnostics, minor surgery, outpatient facilities and access to social services in one location. 

• Pilot a new NHS “Life Check” (initially by questionnaire) to assess people's lifestyle risks, the right steps to take and provide referrals to specialists if needed.

• introducing incentives to GP practices to offer opening times to help patients in their area

• Improving the services in deprived areas by additional money

• Supporting people to self care by investment in the Expert Patient Programme

• Developing an “information prescription” for people with long term health and social care needs and for their carers

• Providing a Personal Health and Social Care Plan as part of an integrated health and social care record

• More support for carers including improved emergency respite arrangements

Professor Ara Darzi had worked at the Central Middlesex Hospital in the 1990s when it was developing a groundbreaking ambulatory care unit and had joined the NHS Modernisation Board.  He was used as a flying ambassador to look at local health problems, e.g. Kidderminster and Bishop Auckland, became chair of the London Modernisation Committee and a trusted adviser on health issues to Labour. He was knighted in 2002 for services to medicine. In 2006 Sir Ara Darzi was asked by David Nicholson, Chief Executive of the NHS London (the London SHA) to undertake a review of services which appeared as A Framework for Action. One of its fundamental proposals was the establishment of polyclinics to integrate primary care, support services and specialist outpatient services.  Wishing to involve clinicians, he hand picked many for clinical working groups and received support both from the SHA and the management consultants, McKinsey's, who provided the secretariat for many subgroups and was probably involved in some of the writing.  Around the time Gordon Brown became Prime Minister in June 2007 he attended a presentation on health issues by Ara Darzi, and when Brown selected his Ministers, Darzi was one of the GOATS, outside people to take part in a "government of all talents", and became a life peer in the House of Lords. His influence increased rapidly and it was rumoured he had the PM's mobile phone number.  His views and reports came to influence health service policy, hospital system restructuring and issues of quality.  Darzi, a clinician, was driven by quality.  He said "I believe what I would like to be said is that I focused our minds on what matters most, with quality being the organizing principle of any health care system. It is quality that wakes me up in the morning to come to work, it is quality that my patients expect from me." ^{April 27, 2009 in Knowledge@Wharton}  

Darzi, now Lord Darzi of Denham, took charge of the review established by Alan Johnson (2007-2009).  The timescale was to be rapid - less than a year - and clinical issues were considered within the framework already set out in the London review.  Many SHAs were already reviewing their services and some took the new initiative more seriously than others.  In October 2007, at a time when the possibility of a snap election was being discussed, Lord Darzi published an interim report setting out a ten year vision, Our NHS, Our Future.   The individual regional SHA's reviews, published in April-June 2008, were long on vision and short on detail.  They followed the tone of what the centre expected but were far less ambitious than the London report.  A final report of the Next Stage Review High quality care for all appeared in June 2008 covering all regions save London.

The decision to abolish GP fund holding led to a search for other methods of giving primary care power and influence over the use of money in the hospital sector.  From this flowed the Primary Care Groups and later Primary Care Trusts.  Like a pack of cards, other organisations had to change to fit in.  As PCTs were given substantial control over expenditure, the function of Health Authorities diminished and they were abolished.  The organisational structure began to unwind and the functions of the regional offices and the Department of Health came under scrutiny.  Ultimately change affected every level from the GP to the Secretary of State. 

The NHS Plan (2000) set in train the largest reorganisation of the NHS for many years.  Mr. Milburn said that the NHS seemed top heavy, with the NHS Executive, eight regional offices, 99 health authorities and confused lines of reporting.  Power would instead move to the front-line.  The regional offices were reduced in number to four; with a regional director for health and social care and a small core of staff, part of the Department of Health and co-located with other government regional functions.

The Health and Social Care Act (2001) gave Government new powers, which allowed the Secretary of State to form or give grants to companies to provide services formerly provided by the NHS, and to employ doctors, nurses and other clinical staff.  It also made possible a new form of Trust, Care Trusts, which would provide closer integration of health and social services, have local authority members on their boards, and might have pooled budgets, commissioning arrangements spanning both health and social services and the ability to delegate functions.   They would be based either on a PCT or an NHS Trust and encourage partnership and integrated provision.  Areas that already had well-developed integrated services, for example Wiltshire, planned to introduce such trusts.  Broadening the range of options for health and social services  to deliver integrated care, they would be able to levy charges, in particular for 'personal care'.  The first such trust to be approved was Northumberland, where the Northumbria Healthcare Trust would be associated with social care services, have a budget of £330m, and over 1000 staff. Three other new care trusts, in Bradford, Manchester and Camden & Islington, united mental health trusts and social care.

The Department would

• set strategic direction, distribute resources and determine standards

• ensure integrity of the system through information systems, staff training and support for development

• develop values for the NHS through education, training and policy development

• secure accountability for funding and performance, including reports to Parliament.

Workforce Confederations that planned health service manpower were integrated into the SHAs, and developed 'clinical networks' (as the Regional Hospital Boards in 1948 had matched universities and university medicine). They could associate to discharge functions better fulfilled together.  The five London SHAs did so, dividing certain responsibilities, for example children's services, or the Ambulance service, between themselves.

The organisation and management of primary care had changed comparatively little over the years.  Now there were radical and progressive alterations. Before long the organisations confusingly named as "Primary Care" had expanding responsibilities that spread far wider into commissioning most hospital care, much under a tariff system.. 

Labour had abolished fundholding and made the formation of primary care groups a centrepiece of its reforms.  The knock-on effect of this on the rest of the NHS structure was only slowly appreciated.  Health service money was increasingly be disbursed through primary care groups and trusts.  Only a minority of NHS managers had experience in primary care - most gravitated to the hospital service.  Organisational development and training, information technology, and the resources necessary to develop primary care management had been lacking. Legislation underpinned their introduction in April 1999 when Family Health Services Authorities (FHSAs) disappeared and 481  Primary Care Groups (PCGs) were established in England and fundholding ended  in England.

GPs were now brought together organizationally with community nurses within PCGs to integrate GPs, community health and social services.  PCGs, initially subcommittees of health authorities, were a step for GPs into a corporate world.  They had complex functions including the provision and commissioning of care, and partnership across public, private, personal and voluntary care sectors and were said to have a lead role in improving health, reducing inequalities, managing a unified budget for the health care of their registered populations, improving quality, and integrating services through closer partnerships. 

PCGs ran for a while in parallel with their health authorities while evolving, often by merging with others, to become Primary Care Trusts (PCTs) with wider functions including clinical and financial responsibility for prescribing and referral decisions.  The number of health authorities began to fall, driven by a progressive reduction in their responsibility for commissioning services.  In the first wave  in April 2000, 17 PCGs became PCTs.  By 2002 there were 302 PCTs each covering populations averaging about 170,000. There was wide variance in the number of PCTs in each SHA and in their population size. Most PCT boundaries were set with coterminosity in mind, matching the boundaries with those of local authorities.  In London there was always a match with local authority boundaries. 

The advantages of being big - managing risk and economies of scale - clashed with the advantages of being small, adaptable to local needs and being close to primary care. As Trusts grew bigger their discussions were increasingly concerned with broad planning issues (for example the commissioning of complex supra-regional hospital services), and less in details of individual practices and patients.  PCTs were very expensive organisations and many merged for this  reduced the transaction costs of contracting. When the first chief executives were recruited there was no knowledge of the major role expansion about to happen - responsibility for the bulk of NHS funding.  The pool from which the appointments were made was therefore comparatively small but because of the turmoil of change, PCT staff came from many different organisations with different types of skill. In April 2003 allocations were made directly to PCTs and the health authorities were wrapped into SHAs.  The allocations to PCTs followed the earlier principals of RAWP.  In 2008  four elements were used to set PCTs’ actual allocations:

NHS Trusts

Hospital trusts were least affected by devolution day, although they were expected to encourage the growth of clinical networks across NHS organisations and work with local authorities. Their lines of accountability changed repeatedly as the organisations around them shifted their functions. High performing Trusts would earn greater freedom and autonomy in recognition of their achievements. They were accountable upwards to regional officers and later to SHAs for their statutory duties, and to health authorities and later primary care trusts for the services they delivered. The separation of planning from provision and decentralization of hospital management was maintained.  Trusts had to consider the provision of family friendly employment policies, networks of clinicians within the NHS, and with social services. The number of Trusts fell through merger; 22 trusts merged in 1998 and a further 49 in 1999.  Like PCTs, Trusts were responsible for minor capital works, receiving block capital allocations for the purpose.  As employers they were represented on the Workforce Confederations.  Strategic Health Authorities would control further capital allocations to aid strategic change and modernisation.

The concept of foundation hospitals and trusts is said to have emerged in 2001 when Alan Milburn visited a Madrid hospital freed from detailed bureaucratic control and able to borrow money from big banks, rather than using funds under tight public control. Perhaps government, having attempted to micromanage the NHS, had realized that with control went responsibility when things went wrong and political fallout.  The idea was trawled in a speech to the New Health Network in January 2002, and several trusts soon expressed an interest in piloting the proposals. In July 2002 acute hospital trusts were told they could apply to be "NHS foundation trusts". Legislation was necessary and details appeared in December in the circular The guide to NHS Foundation Trusts.  Two central ideas were a new form of social ownership with services owned by and accountable to local people rather than to central government, and decentralization and devolution

Each NHS Foundation Trust would have a Board of Governors representing the interests of patients, staff, local partner organisations, local authorities and the local community.  The Secretary of State for Health would not have the power to direct, nor be involved in appointing their Board members. The Trust's Management Board would be accountable to the Governors, who would elect the chair and non-executive directors.  It was a complex model - perhaps over complex - and not entirely to the liking of some managers.

Foundation Trusts were part of the NHS but had greater financial and managerial autonomy including  freedom to retain surplus finances, to invest in delivery of new services and the flexibility to manage and reward their staff. The Department of Health wanted trusts to be free to borrow money off the public balance sheet;  the Treasury did not, fearful that trusts would run up debts that they could not handle and would need to be bailed out at public expense.

The idea split the Labour Party. Some MPs feared that foundation status would fragment the NHS and create a two-tier system in which the best hospitals could get more cash and poach staff, that it would effectively denationalise the NHS and allow back-door privatisation. Conservative, Labour and Liberal Democrat MPs all had objections. As a result Trusts' freedom was progressively constrained.  NHS foundation trusts would be able to borrow to improve services, but borrowing would be on the government's balance sheet and come off the departmental expenditure limits that the Treasury had agreed. Pay and conditions of service would be within The Agenda for Change, a national personnel policy. They would be accountable (through contracts) to PCTs.  Contracts with PCTs would last several years to provide some financial stability and would be legally binding.  There would be an independent regulator  (Monitor) to supervise them and decide what services should be provided and if necessary dissolve Trusts.  There would be safeguards to prevent the sale of hospitals or their assets and limit the extent to which NHS foundation trusts could undertake private practice, a huge problem for some hospitals such as Great Ormond Street that had a massive international practice.  Nevertheless foundation trusts would be able to redevelop and reequip themselves more easily and carry over surplus money year on year.  Just as, ten years previously, hospitals had been invited to apply for Trust status and this had become the norm, it was now expected that the norm would be NHS Foundation Trusts.

In March 2003 the Health and Social Care (Community Health and Standards) Bill was introduced to provide the legislative framework for foundation trusts (and other new organisations such as CHAI). John Reid took the Bill through the House and many Labour MPs voted against it; indeed it was the votes of Scottish MPs, whose constituencies were unaffected by the legislation, which saved the government when the Bill first passed the Commons in July 2003. From then until November 2003 the Bill was passed acrimoniously from the Commons to the Lords and back again.  To allay concern on Labour backbenches, John Reid asked the Healthcare Commission to carry out a review of the first 20 Foundation Trusts.

Foundation trusts remained divisive.  To the proponents they would set the NHS free from the yoke of central government.  To opponents they were a backdoor privatisation that would destabilise the NHS and introduce a two tier service.  Some claimed that they were in the teeth of Bevan's vision for the NHS and destroyed concepts of equity and universality.  Others believed that a varying quality of service from place to place was inevitable within such an immense health care system, that patient choice was required and that more freedom encouraged development and improvement of the NHS to the benefit of all.  The Bill appeared the most controversial piece of legislation to come out of the government's 10 year strategy for the NHS in England. It eventually passed in November 2003. At the same time it was a ministerial objective to offer all trusts the opportunity of foundation status within five years and John Reed gave a further twenty the green light to apply for foundation status in July 2004.  Monitor made it clear that the level of financial and managerial expertise required would not be lowered..

In July 2005 the Healthcare Commission submitted its report on the first 20 trusts.  The findings offered something for both proponents and detractors and  found that NHS Foundation Trusts had:

• increased the ability to plan and develop new services and relate to their local populations;

• used their financial freedoms for capital investment and improved services, for example, offering specialist services in the community;

• increased local public and patient involvement through Board membership

• maintained standards of care in terms of access to and quality of care and positive relationships with local commissioners and other local providers.

They had not destabilised local health services by using unfair competition to attract staff; ‘cherry picked’ patients who were easier to treat; had continued to invest in staff education and training; and mostly worked in partnership with other NHS services and organisations in the local health community. The Healthcare Commission hoped that Trusts could have more information on the future direction of health care policy, for example if they could move into the provision of primary health care and vertical integration of services.  There would be a further review in two years. However there was uncertainty in the service as to whether the centre would wish to reassert authority as more and more trusts became Foundation Trusts, or whether a market would gradually become firmly established.

By the 60th anniversary of the NHS in 2008 there were 103 foundation trusts, with government encouragement for more. On occasion the debt burden of a PFI project made attaining Foundation status difficult, as at the Royal London Hospital with its £1 billion development. A Foundation Trust Network was established to represent their interests, and organizationally they were maturing and delivering a sound financial performance.  Monitor, surveying Trusts in March 2008 found that trusts were working well,  most governors were engaged with their Trusts, understood what was required, enjoyed good relationships with their Chairs and believed that they were making a difference. They were finding greater difficulty in engaging with their local community. Most felt they were kept well informed about the Trust's activities.  While many were not using all the powers that they had, for example raising money for capital development, some were adopting stratagems to increase their critical mass by associating with other hospitals, or in the case of specialised trusts such as Moorfields (eyes) and the Marsden (cancer) developing satellite units off site. Mental health trusts, in particular, used their new freedoms to good effect.

NHS structure July 2004

The organisational changes that later took place under John Reid were essentially decided while Alan Milburn was Secretary of State. The regional offices were running down, and PCTs continued to merge or be associated in clusters.  

Finance

Financial problems were a central issue during the decade and the Prime Ministers, Tony Blair and his successor Gordon Brown, were deeply involved.  The two key issues were the total volume of money coming to the NHS, and the system by which it was distributed to trusts.  A more commercial framework was introduced, particularly in the case of Foundation Trusts..  Financial tricks that had enabled authorities to conceal deficits, such as the transfer of capital to revenue, or borrowing money from other trusts, ceased. (Timmins N, BMJ 28 April 2007,  334, 877). The system became more transparent. 

The growth money available to the NHS varies from year to year.  

The total money for the NHS

The NHS is funded mainly through general taxation (74%) with an element coming from national insurance contributions (20%). The funds for the health service are the result of annual or bi-annual negotiation between the Department of Health and the Treasury. The NHS is pressured by. 

• Pay rises

• The pay structure of all NHS staff  was being "modernised", costing money

• New patterns of service, for example out of hours cover in primary care that proved much more expensive

• Failure of capital investment in staff training (nurses and doctors) from the 1970s to the 1990s made it difficult to use additional funds effectively and efficiently and capacity bought in from the private sector was at a high cost

• Costs of drugs and medical technology continued to rise, NICE creating an additional imperative

• The mean age of the population continued to rise   (see Professor Peter Richards, letter to The Times, 28 June 2005)

Clive Smee, for many years Chief Economist at the Department of Health, says that the arguments used to justify more money for the NHS changed over the years.  In the 1980s the changing age structure was held to require an additional 1% a year for the health service merely to stand still.  Relative price effects also played a part - inflation in the NHS seemed to run at a higher rate than in the economy more generally.   In the 1990s more weight was placed upon service trends, a proxy for public expectations, and the need to invest in the NHS if it was to be brought up to date.  From the NHS Plan onwards, better information about the performance of the NHS, particularly the poorer outlook of those suffering from cancer in England as compared with Europe, became significant.  It was seen as necessary to "catch up" after many years of low investment, to provide safe high quality treatment, faster access and clean comfortable accommodation.  The costs of medical advance came to the fore with NICE and National Service Frameworks that could be costed with some accuracy.  Finally, international comparisons of health service costs achieved greater importance.

Since 1976 it had been government policy to allocate money as fairly as possible between the different regions in England.  Equity between England and the other three parts of the United Kingdom was a political matter governed by the Barnett formula.  The allocation formula, which took account of mortality and other factors affecting health care costs, was an improvement on the historic allocations that had gone before but was regularly criticized and modified.  Even when weighted by population characteristics, allocations varied substantially from area to area by a ratio of 3:2.

On taking office Labour stuck to the Conservatives' spending plans for the NHS and money was initially tight. Only small additional sums were announced for the NHS and when inflation was taken into account there was less than was vaunted.  Some was required to cover existing overspends, pay claims and new tservices.  Labour had a disarming tendency to announce the extra money available over three years, apparently tripling its generosity.  The financial problems of the NHS became increasingly acute.  The 'bad winter' that the NHS encountered in 1999/00 was a crucial factor in public opinion and political motivation, revealing just how serious the gap between service and demand really was, at least in some parts of the country.  It crystallised the act that Labour's first two years in office had not delivered substantive improvement. The sad death of a patient, Mavis Skeet, a pensioner whose surgery was cancelled four times until her cancer became inoperable, also led to an overhaul of intensive care capacity.  On 16th January 2000, Tony Blair told a startled Sir David Frost on television: "If this July when we work out the next three-year [spending] period we can carry on getting real terms rises in the health service of about 5%, then at the end of that five years we will be in a position when our health service spending comes up to the average of the European Union."  After Tony Blair's commitment the government accepted that major injections of money were needed and provided them. 

World-wide, health care systems were under comparable pressures.  In the US there was an acceleration in growth of expenditure in part because of the slower growth in managed care enrolment and a movement towards less restrictive forms of managed care driven by consumer pressure.  Some thought that managed care was an experiment shown to have failed for the United States (2007/8) spent about 16% of its annual gross domestic product (GDP), or $6,400 per capita.. 

The Wanless Review

When government forms a committee it is conventional to select people likely to make the recommendations that government wishes to see.  The Treasury commissioned Derek Wanless, past chairman of NatWest Bank and a non-executive director of Northern Rock Bank, in perhaps the most expensive report ever requested, to estimate the resources required to run the NHS in 20 years time. To assess what was needed to provide good standards of care was a new departure. From Guillebaud (1956) onwards  it had been believed that there was no way of defining an acceptable standard of health service.  Financial reports were concerned with getting the best service from the resources available, not what should be spent to achieve defined objectives.  Wanless tried to assess the service costs of, for example, National Service Frameworks. In an interim report appeared in November 2001, Securing Our Future Health: Taking a Long-Term View, and a final one in April 2002.  he said that there was no evidence that an alternative funding system would deliver a given quality of health care at a lower cost to the economy, the current method being both fair and efficient.  Wanless pointed to the low level of health expenditure in the UK, believed this to be related to our poorer health outcomes than some other European countries, and questioned  the assumption that the pursuit of quality would be cost free.  An extra billion pounds was allocated by government shortly after.  There was debate about other methods of funding the NHS than central taxation.  Government rejected alternatives such as social insurance. Derek Wanless said that the country needed to devote a significantly larger share of national income to health care.  But money on its own was not enough  – it was essential that resources were efficiently and effectively used.  The report saw a wider role for NICE, and an extension of the National Service Frameworks to cover a wider range of diseases. The Report set out projections of resources required over the next 20 years, outlining three future scenarios; an optimistic one - the money was wisely and productively used and people demanded better services but learned to look after their own health better, a pessimistic one where people were less involved with health issues and the NHS remained unresponsive, and a middle course in which there was solid progress but not all the desirable changes occurred. The projections showed the UK spending between 10.6 and 12.5 per cent of GDP on health care by 2022-23, compared to 7.7 % in 2002.  The average annual real terms growth rate in UK NHS spending would be between 4.2 and 5.1 per cent over the 20 year period, showing the highest growth in spending in the early part of the Review period – an average of between 7.1 and 7.3 per cent a year in real terms over the first five years to allow the NHS to ‘catch up’ to standards elsewhere and to create the capacity essential to expand choice in future.  Investment in new hospitals and more doctors was long term in its nature, and would not produce rapid improvements.  Subsequently Wanless was asked by the Treasury to provide an update on the problems of achieving the optimistic (fully engaged) scenario, a report on population health trends appeared in December 2003, and another report in February 2004. One of his recommendations was that after five years there should be a review of how additional money had been spent.  The government did not do so but the King's Fund did.

In spite of the increasing funds, the financial state of the NHS worsened.  The  targets and the cash had not been matched one with the other and in January 2002 the South-East Regional Chief Executive said it was necessary to eliminate an overspend of £60 million overspend by the end of the financial year.  It was rumoured that the Chancellor would raise taxation to help the NHS or that Labour would move away from a fully comprehensive and free NHS.   On TV in February 2002 the Prime Minister, Mr. Blair, said money would need to be found.  He believed that general taxation was preferable to social insurance or private health care. In March the Labour Party issued a consultation document,  Improving Health and Social Care, to explore the issues and challenges to be faced.  Conceding under-funding of the NHS over a number of decades, it was the size of the under-funding, rather than the method of funding, which was to blame.

In January 2002 a House of Commons health committee inquiry heard that in Croydon implementing the government's top 20 priorities would cost £70 million, at least ten times the available budget.  In Lambeth, Southwark and Lewisham Health Authority NICE guidance would cost £15 million to implement, depriving patients of other equally effective new treatments, such as new anti-rheumatic drugs.  Some policies would have to take a back seat in the attempt to meet the government's other top priorities. ^{(BMJ 2002: 324; 258)}

In his April 2002 budget Gordon Brown provided a huge increase in NHS funding over the next five years. There would be year-on year rises in UK spending from £65.4bn in 2002 to £100.6bn in 2007, 7.4% in real terms annually and slightly above the Wanless proposals.   National insurance contributions were raised by 1% to find the money (immediately costing the NHS an additional £200 million as it was a large employer).  The BMA and some medical peers had long pressed for such a supplement for the NHS form national insurance contributions.

Would the massive injection of money would achieve results?  Beverly Malone, the Chief Executive of the Royal College of Nursing, looked for a big pay settlement; "the money is there and the success of modernizing the NHS is riding on the shoulders of the nurses".   Other unions made similar noises.  In November 2002 the UK Health Departments’ NHS management representatives’ and staff organisations’ negotiators concluded negotiations on the Agenda for Change, a package of proposals for a new pay system covering all staff, save the most senior managers and those covered by the Doctors and Dentists Pay Review Body. There would be a minimum NHS wage of £10,100 per year and a new starting salary of £17,000 for newly-qualified nurses and other health professionals. At local (PCT) level there seemed little improvement.  Pay rises, changes in junior doctors' hours, and rising drug costs immediately swallowed much of the money.

In December 2003, a further report Securing good health for the population, commissioned by the Treasury six months previously from Derek Wanless was released with a minimum of publicity. Setting out the public health challenges to be faced it the Wanless "fully engaged" scenario was to be met, it painted a picture of a country that compared unfavourably with other major Western countries in terms of mortality and morbidity from cancer and heart disease. Derek Wanless also found wide variations in life expectancy across the socioeconomic groups.   By April 2006, Wanless had come to criticise the extent to which the money made available to the NHS had been spent on salaries, rather than on long term measures to boost health promotion and public health.

Payment by results (PbR)

Historically lump sums had been paid to individual hospitals.  Now payments received by trusts increasingly depended upon the number of cases handled, paid for on the basis of a national tariff.  Known as payment by results, really payment by activity, money would move with patients.  This had been the intention of the Conservative NHS reforms in 1990.  In October 2002 the government issued Reforming NHS financial flows - introducing payment by results.  A phased programme from 2002/3 to 2005/6 would require PCTs to

• Pay NHS Trusts and other providers on a fair basis while managing demand and risk

• Support patient choice by ensuring that diverse providers were funded according to where patients choose to be treated

• Reward efficiency and quality

• Help match capacity to demand

• Reduce transaction costs and negotiating disputes over price between PCTs and acute trusts

• Enable PCTs to concentrate on quality and quantity rather than price by setting national tariffs that provide fair prices

Block contracts would be scrapped and a tariff-based system would be introduced.  Service Level Agreements would link funding and the volume of services; in theory removing discussions on cost should lead to concentration on quality.  The basis for the system of costing had been developed in the US as diagnosis related groups (DRGs).  An English version of "health resource groups" (HRGs) had been under development since the Conservatives' NHS Reforms although the inadequacy of hospital accounts at that time made the introduction of standard costing systems impossible.  HRG costings would expand progressively to cover inpatient and outpatient care, and elective and non-elective services in medicine and surgery. Prices would have to vary because costs differed from place to place.  However it was hoped that patient choice, quality and access would drive changes in patient flows.   The national tariff would need adjustment for local market forces (high cost in London was a fact of life). There were many other factors, for example the development of new units, the higher expenses of teaching hospitals, the cost of teaching in all hospitals as the number of medical and nursing students grew, the funding of services that were complex and essential, almost regardless of demand (e.g. burns units) and whether private or NHS facilities were involved.

Tariffs operated for elective activity in 15 groups in 2003/4, and progressively expanded.   Reference costs were calculated to provide the unit cost  for a wide range of treatments and procedures, down to the level of individual treatments.  A tariff derived from them, underpinned Payment by Results, provided a national price schedule for treatment in England.

PbR introduced a moral hazard, well known in the USA, where providers (hospitals and doctors) might over-bill, while purchasers would "down code". In the US a judge in a case described the situation  as "almost all doctors versus almost all major health maintenance organizations".  UK providers were accused of driving up costs and exploiting the  system by overcharging for their work. Purchaser organizations were accused of systematically obstructing and delaying payment for legitimate services.  Other problems affected the larger teaching hospitals with their higher expenses. A new system of paying money for medical research was introduced and the large research-oriented hospitals were likely to suffer.  Secondly, it was proposed to change the in the way the service increment for teaching (SIFT) was paid.  The historical allocations might be scrapped in favour of a simpler system that paid an average amount per student year.  This created winners and losers.

There was now extensive experience of many different patterns of commissioning, some with high transaction costs, others that permitted a greater degree of patient choice and responsiveness.  There were few clear lessons from evaluation studies save that the NHS needed a raft of different but effective commissioning models.  Commissioning at single or group practice level might be best for some services.  Others needing larger populations might need a regional or national system.

source Health Foundation, Report dated September 2004

Practice led commissioning, a further initiative in April  2005, allowed Primary Care Trusts to devolve indicative budgets to practices.  The practices did not hold the money, but there were financial incentives to manage referrals and commission and redesign services to make them more convenient, appropriate and cost effective.  The Audit Commission reported on the second year of the scheme. (Putting commissioning into practice, Audit Commission, 22 November 2007). Those practices involved had become more financially aware of the consequences of their decisions, but in general progress had been slow  and some GPs thought that they had inadequate support from PCTs in developing commissioning.

Recurrent financial problems

In spite of the high growth rate  a major financial crisis developed from 2005.  The increasingly commercial nature of the NHS financial system made it more difficult to hide deficits, for example by brokerage (loans between authorities, often not repaid.)  The movement to PbR was difficult because the new system created winners and losers.  In theory around 70 trusts would lose over 25% of their current income.  Others would receive significantly more than they were spending. All income would reflect activity, no portion relating to fixed costs. Neither was there a guarantee that the sums payable would fall within budget allocated - the sum of the many bills exceeded the funds voted by Parliament by a substantial measure. One problem was that the estimates had not taken account of the extent to which most trusts had subsidised health care by using non-recurrent money, land sales etc. PCTs found themselves more deeply committed than they had expected and £637 million had to be redeployed from educational budgets to narrow the gap.  Nursing school intakes and medical postgraduate education were cut.  "Over performance" by some trusts beggared their PCTs .

Many hospital trusts, at the end of the financial food chain, found themselves in dire trouble.  They were hit by under funding for the consultant contract and the money spent on buying in extra capacity at high cost to meet targets. A number of trusts had longstanding deficits that could not be eliminated without painful cuts in patient services. Primary Care Trusts also had to meet the cost of the new GP contract, for the average net salary rose from 2003/5 to 2004/5 by over 30%, to more than £100,000.  According to the parliamentary select committee on health, the Department of Health had miscalculated the additional costs of these contracts and possibly the Agenda for Change as well. Patricia Hewitt told the parliamentary select committee that the NHS had employed more doctors than the central planning had intended or that Trusts could afford. While NHS Employers had been involved, the Department had themselves taken many of the key decisions.

In mid-2005 an assessment suggested that six SHAs had no hope of reaching financial balance by 2008 and would need significant help to pay off debts and get in balance.  Eleven SHAs would need to make savings of £250 million.  (HSJ 2005, 14 July, p5)   It seemed possible that the knock on effect on NHS pensions had also been overlooked.  A deficit of £140 million was predicted for 2005/6 and the final figure was £547 million, reduced significantly only by a huge subvention from SHAs created by cutting the NHS training and education budget.

When in 2006 the King's Fund analyzed where the money had gone, almost half had been spent on higher pay for staff, and another 27% on increases in capital costs, the cost of clinical negligence and on drugs, meeting the recommendations of NICE.  Little was left for service development or, indeed meeting targets such as waiting list reduction.

After 5 years of historically high growth the NHS still had problems..  Why?  No single reason but a myriad of activities.  Massive expansion in capacity had improved access to services, there had been several structural changes, the introduction of targets that had financial repercussions,  and not only were there many more staff but there was a wholesale increase in pay of every group, Consultant pay £90 million more, Agenda for Change £80 million more and GPs £300 million more than expected.  Simultaneously treatment was of  increasing complexity.  In its programme, The Blame Game 26 March 2006,  the BBC's Panorama placed the blame firmly on Department of Health policies and Ministers.  A multitude of new policies, not all compatible with each other, made the task of trusts difficult.  Ministers implied that NHS management was responsible for overspending as a result of factors that were way outside its control. The profession blamed government. The Department was insistent that the NHS should remain within its budget. Some hospital and primary care trusts openly delayed treatment as far as they could, while trying to remain within guidelines for speed of care. Others closed wards, and delayed payments even to partner organizations in health or social care. The Department sent management consultants  into some 60 Trusts with a substantial deficit and later sent  "Turnaround Teams"  in January 2006 into eighteen trusts.  They did little to help. Increasingly it was necessary to cull jobs.  A few SHAs suspended the introduction of Payment by Results, fearing that paying hospitals for the work that they did would increase problems.  By early 2006 there was disarray for a government that had indeed increased the money for the NHS substantially, only to find it absorbed by its own policies, targets and pay agreements. To make matters worse, SHAs and PCTs were heading for mergers at the very time when they were key to controlling the "overspend". As the financial crisis continued to grow, tensions arose between Ministers and civil servants and in March 2006 the chief executive, Sir Nigel Crisp, after five years at the helm, accepted some responsibility and took retirement.   Sir Nigel's successor, Mr. Nicholson, giving evidence to the Committee of Public Accounts in October, admitted that the Department "could be better at costing some of our policies."(BMJ 21.10.06 p 821)  The BMA blamed the private finance initiative, independent treatment centres and the employment of management consultants. Derek Wanless saw the financial crisis as a threat to health promotion and social care. The Prime Minister saw it as essential to move forward with reform before the next election loomed too closely and the flow of the additional moneys that had been provided lessened.

Patricia Hewitt, Secretary of State for Health, told MPs on 21 November 2006 "we will return the NHS as a whole to financial balance by the end of March [2007] and I will take personal responsibility for that."  This accentuated the problems for the service because of the pressure and threats on management and clinicians.  In some areas debt ridden PCTs said they could not pay for services carried out. To attempt to control their budgets PCTs established teams of financial analysts to look at hospital bills; hospitals had to respond by increasing the costs of their own finance departments.  Trusts might have to delay patient admissions until a time after which they might receive payment, yet meet target times for the completion of treatment.  A small proportion of staff were made redundant.   In the Spring of 2007, it seemed that some 15-20 NHS Trusts were in such deep financial trouble that their position seemed irrevocable within ten years.    Government limitation of annual pay awards led to threats of industrial action by several staff groups.  While the NHS as a whole remained in budget at the end of the financial year, there was an increase in patient waiting times as services were reduced.

Patricia Hewitt delivered on her promise that the NHS should end in overall financial balance, though 82 out of 372 NHS organisations had a combined deficit of £97million, concentrated in a small number of organisations some of which had problems hard to resolve. 

Criticism mounted as to how money was being spent.  The King's Fund commissioned Derek Wanless to take stock. The review, published in September 2007, concluded that increases in NHS moneys had broadly matched assumptions made by the 2002 review.  Pay and contractual changes for all NHS staff groups over five years had contributed to higher input costs, with benefits yet to be fully realised.  NHS Plan commitments to employ 7,500 more consultants, 2,000 more GPs, 20,000 more nurses and 6,500 more therapists (allied health professionals) by 2006 had been more than achieved, with targets exceeded by 16 per cent, 166 per cent, 272 per cent and 102 per cent respectively.  Building, both of hospitals and for primary care, had made much progress.  The funding increase had helped to deliver some clear improvements – more staff and equipment; improved infrastructure; significantly reduced waiting times and better access to care; and improved care in coronary heart disease, cancer, stroke and mental health. On balance the flood of cash had brought disappointing results..

From 2002 until 2007 NHS funding had risen at 7.2% per year.  In October 2007 the chancellor announced that for the next three years spending would increase at 4% per year, more than had been expected but less than the increases to which the NHS had become used.  The corner had, for the present, been turned.  The NHS had returned to financial balance.  Indeed the year 2007/8 showed an embarrassing underspend, because Trusts had become used to making economies.

Quality, performance and clinical governance

Quality became a centre point of NHS policy and government became increasingly active in this field. With a few exceptions, such as the maternal mortality survey, quality initiatives had been unusual in the UK.   It was assumed that the 'producers' rather than the 'consumers' knew what services should be provided.  Increasingly it was recognised that it was the customer rather than the provider who ultimately defined quality.  The NHS had discovered the patient. Frank Dobson established bodies such as CHI and NICE concerned with quality.  It became one of the commitments of NHS Trusts on which they were assessed. The publication of morbidity and mortality data, though far from reliable, gradually increased. Chief Executives were expected to handle quality as  well as their budget and their capacity.  A Quality Outcomes Framework became one of the drivers of the pay of family doctors.  As the theory of quality assessment developed, the tools developed were introduced into the NHS.

Quality could considered in terms of

• Variations in the performance of hospitals and their staff

• Variations and underperformance of clinical staff

• Attempts to improve the care and cost-effectiveness of NHS organisations as a whole

Hospital performance

The USA had a lead of many years in quality issues. A timeline shows the long involvement of the Joint Commission on Accreditation and the Agency for Healthcare Research and Quality (AHRQ). The Institute of Healthcare Improvement, a non-for-profit organization leading the improvement of health care throughout the world based in Cambridge, Massachusetts, was founded in 1991.

Quality of life measures, for example the pioneering SF-36 from the US, were brought to the UK. In the USA  the Centre for Quality Improvement and Patient Safety within the AHRQ and in the UK the National Patient Safety Agency (UK) were taking quality seriously.  Websites provided a forum and focus e.g. www.qualityhealthcare.org and www.saferhealthcare.org.uk. The work of  John Wennberg and the Dartmouth Atlas showed unwarranted variations in health care delivery; variations in the rates of coronary artery and carotid artery surgery, even in the best academic centres, was a reminder of how empirical was much of clinical medicine. The literature recorded the substantial number of medical errors in routine treatment and 'near misses'.   In a study of  New York in 1990 the principal source of many errors were the systems rather than individuals. An extensive review by RAND Health documented shortcomings in safety and effectiveness. ^{(Schuster MA et al, Millbank Quarterly 1998; 76: 517-63)}. In 1999 a major report was published by the Institute of Medicine directed at politicians and healthcare leaders as well as doctors. ^{(Kohn LT, ed, Corrigan JM, ed, Donaldson MS, ed. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 1999).}  It was followed in 2001 by Crossing the Quality Chasm, (Committee on Quality of Health Care in America.  Washington, DC: National Academy Press; 2001.)  which showed that the implementation of standardised performance measures for heart attack, heart failure and pneumonia by the JCAHO in 2002, was followed by significant improvement in outcome. ^{Williams SC, Schmaltz S, NEJM 2005 353: 255-264.}  A review five years after the publication of To Err is Human showed substantial progress to increase hospital safety was being made, at least in the US, often led by clinicians keen to improve patient care. Five Years After To Err Is Human: What Have We Learned? ^{Leape and Berwick JAMA.2005: 293: 2384-2390.}  A further Institute of Medicine report in 2008, Knowing What Works in Health Care: A Roadmap for the Nation, proposed a national program to assess the effectiveness of clinical services and to provide credible, unbiased information about what really works in health care. It recommended that Congress direct the U.S. Department of Health and Human Services to establish a program comparable to NICE on the UK to conduct systematic reviews of the evidence and develop standards for creating clinical practice guidelines.

Qualify adjusted life years (QUALYs) and patient recorded outcome measures (PROMIS) were increasingly used in assessing the effectiveness of interventions.

In 2000, the US Health Care Financing Administration (now the Centers for Medicare & Medicaid Services) reported on 24 indicators of the quality of care delivered to Medicare beneficiaries in 1998-1999.  These indicators measured delivery of services that evidence showed to be effective in preventing or treating breast cancer, diabetes, myocardial infarction, heart failure, pneumonia, and stroke. (Jencks SF, Cuerdon T, Burwen DR, et al.) Quality of medical care delivered to Medicare beneficiaries: a profile at state and national levels. JAMA. 2000;284:1670-1676.  The Institute Healthcare Improvement launched its "100,000 Lives Campaign in 2004, targeting 6 interventions where quality improvement could save patients.

100.000 Lives Campaign interventions Deploy rapid response teams to patients at risk of cardiac or respiratory arrest Deliver reliable, evidence based care for acute myocardial infarction Prevent adverse drug events through drug reconciliation (reliable documentation of changes in drug orders) Prevent central line infections Prevent surgical site infections Prevent ventilator associated pneumonia

In England the clinical performance of hospitals also varied substantially.  An attempt to quantify the problem by retrospective record review in 2001 showed that almost 11% of hospital patients experienced an adverse event, over half of which were preventable with ordinary standards of care.  A third of the events led to moderate or greater disability, or to death.  The Audit Commission, in its report A Spoonful of Sugar, (December 2001) reviewed the use of medicines in NHS hospitals, found that medication errors occurred too often and their effect on patients and NHS costs could be profound.  The National Patient Safety Agency, established in July  2001, produced preliminary results in 2002 from pilot trials in 28 trusts which showed over 20,000 adverse incidents over a nine-month period.  The Department of Health published its own analysis, An Organisation with a Memory (2000).  "Star" ratings were introduced in 2001 but dealt more with the process of its care, rather than quality and outcome.  The system was refined in 2004 with the publication of Standards for Better Health, proposing standards that encompassed safety, clinical and cost effectiveness, governance, patient focus, accessible and responsive care, care environment and amenities, and public health, and the Healthcare Commission incorporated such standards in their annual trust health check. Making the debate public made it more visible and the message clearer.  It made the size of the problem obvious, focusing on events where there was wide agreement that something had gone wrong.  In 2003 the Nuffield Trust published a review, The quest for quality in the NHS: a mid-term evaluation of the ten-year quality agenda. ^{(Leatherman S & Sutherland K, London, Nuffield Trust, 2003),} examining achievement in terms of access, capacity, public perception, effectiveness and equity. The authors concluded that much remained to be done but that  initiatives were moving in the right direction.  The BMJ published an editorial on the report. Te same authors published more than 100 charts demonstrating the UK's performance in international terms, The quest for quality in the NHS (^{2005, Radcliffe Publishing) (Charting a new course, 7 July HSJ 2005, 26-29).}

Staffing ratios

Professional staffing ratios influenced mortality rates.  In the USA research on nurse ratios in surgical units in Philadelphia showed that after adjusting for patient and hospital characteristics, each additional patient per registered nurse increased the likelihood of dying within 30 days of admission by 7%, and increased substantially nurse burn-out and job dissatisfaction. (JAMA. 2002;288:1987-1993). In the UK Professor Brian Jarman & his colleagues standardised for age, sex, socio-demographic background, key diagnoses and the number of emergency admissions.  Hospital standardized mortality ratios (HSMRs) were calculated for each English Trust and the trusts presented sharply different outcomes for patients once all these factors had been taken into account.  The factor that correlated best with performance was the number of doctors on the staff.  Taken overall, the death rates in major English hospitals seemed to be dropping about 2.5% per year. 

Publication of mortality data

For more than a decade league tables of the mortality rates of US hospitals had been published. However mortality rates and other clinical indicators at hospital or trust level were not published until 1994 in Scotland and 1999 in England.  Clinical performance indicators included such items as the number of deaths in hospitals following fractures of the hip, and deaths within 30 days of admission for a heart attack.  As in the USA  publication was followed by protests that data might be inaccurate and misleading.  In the US patients could use not only printed information but web sites to view the number of cases specific hospitals handled, their outcome and the star rating accorded to their local hospitals, e.g. www.healthgrades.com and www.healthcarechoices.org.  In England politicians thought such information should not encourage patients to shop around for better treatment; later with Alan Millburn  this line changed and increasingly data was published, for example on the NHS Choices website.

Dr Foster

An independent company, Dr Foster, was established early in 2001 in the UK to provide authoritative information for patients on health service performance. The unit at Imperial College, directed by Professor Sir Brian Jarman, produces a variety of information.  With an independent editorial board, it mined available sources of information and the Department of Health, recognising its media and presentational skills, became its main customer and it produced systems for the Healthcare Commission as well.  The scope and usefulness of the material on its web site steadily increased, and details of the methodology used were provided.  A Sunday Times Hospital Guide, (15th May 2004) provided comparative information on hospital trusts in England.  While such information was often available in the US free of cost, Dr Foster charged for access and did not provide depth of information on individual clinicians.

Volume and safety

A relationship exists between the volume of some procedures and the outcome of treatment.  In 1996, the NHS Centre for Reviews and Dissemination published a for the procedures where such a relationship existed. It included coronary artery bypass surgery, paediatric heart surgery, acute myocardial infarction, coronary angioplasty, aortic aneurysm, amputation of the lower limb, gastric surgery, cholecystectomy, intestinal operations, knee replacement, and neonatal intensive care.  This suggested that the pattern of NHS hospital services might be modified. A study supported by the US Agency for Healthcare Research and Quality showed that while hospitals with high annual volumes of certain types of procedures had lower death rates, the true association was with surgeons who had a high volume of cases

Variations in the performance of clinicians

In earlier times, all that had been expected of doctors, who had been trained in a service with a strong public service ethos, was that they should do their best by their own lights. Regulatory bodies such as the GMC looked at individual competence.  Colleges would inspect hospitals to see that training standards were maintained.  Internationally a basic ethical principle of medicine, first do no harm, was taken seriously. The ethos of medicine was changing and the  development of controlled trials, meta-analyses, guidelines and organisations such as the Cochrane Collaboration was bringing to an end an era in which clinical experience alone was seen as adequate.

Evidence based medicine

Evidence based medicine was becoming an integral part of undergraduate, postgraduate and continuing educational programmes.  Accurate, accessible and regularly updated sources of evidence were widely available though the process of summarising the evidence was daunting.  It was often hard to show that clinical practice was greatly affected or that clinical outcomes were better, though few would disown the hypothesis that on average providing evidence-based procedures would improve clinical outcomes. The Cochrane Collaboration had been established in 1992 funded by the NHS Research and Development Programme, to help well informed clinical decisions by preparing, maintaining and ensuring the accessibility of systematic reviews.  It rapidly became an international movement, as the Cochrane Library and Database of Systematic Reviews.   How could stroke and its effects be prevented and treated?  What drugs should be used for malaria? Studies could produce compelling evidence for a change to clinical practice.  Often it was clear enough what should be done, for example elderly people should receive influenza vaccine.  Student textbooks were more frequently based on good clinical studies than in the past.

Clinical mishaps

The NHS and professionals were exposed increasing public scrutiny. When serious harm to patients occurred it was commonplace to hold an inquiry, sometimes a public one.  In the 1970s many inquiries were held into mental illness, mental handicap and geriatric hospitals. The same issues were identified repeatedly, as if it was impossible to learn the lessons, e.g. isolation - geographical or organisational,  poor leadership, bad communication, problems with NHS systems or individual's competence  and obstacles placed in the way of those who raised concerns at an early stage.  Occasionally the public expected too much, for example the reading of cervical smears and mammograms is not a precise science and there are always likely to be false negatives and false positives.  Had the media become more active, were staff less disciplined, was the system under too much pressure?  Were there interests that relished the demonstration that professionals had feet of clay?  Financial problems were often involved, as in the case of delayed admissions, waiting lists and 'trolley waits'.   Pressure of work and inadequate supervision played their part. 

While the profession had developed reporting schemes such as that into perioperative deaths, int Bristol at least 29 babies died after heart surgery at the Royal Infirmary.  This led in 1998 to a lengthy public inquiry costing £14 million, chaired by Professor Ian Kennedy, published in July 2001.  There were organisational as well as clinical problems. Neither the Royal College nor the  Department of Health personnel had been alert to information about poor performance and the hospital facilities were far from ideal in the number of staff and the split site.    The General Medical Council (GMC) found three doctors were found guilty of serious professional misconduct.  The BMJ said, in an editorial, that most chilling thought was that there could have been many similar reports about other parts of the NHS. The ingredients in Bristol occurred throughout the NHS. The NHS had no system for monitoring quality, no reliable data and no agreement on what constituted quality. "Thus the most essential tool in achieving, sustaining, and improving quality of care for the patient was lacking . . . clinicians had to satisfy only themselves that the service was of sufficient quality."   The Department of Health, in its response in January 2002, accepted the majority of the recommendations.  There would be a strengthened inspection role for the Commission for Health Improvement (CHI), and a new Council for the Quality of Health Care. No steps were taken to establish this Council, perhaps because Ian Kennedy who recommended it later became the chairman of the Healthcare Commission (CHAI). 

The reports of the clinical work of gynaecologist Rodney Ledward, struck off by the GMC in 1998 after a public inquiry led the media to watch the cases coming in front of the GMC like hawks. The GMC received an increasing number of complaints, 1,000 in 1995, 3,000 in 1999 and 4,470 in 2000. 

The Shipman Enquiry and the GMC

The conviction of Harold Shipman for serial murder dealt a further blow to confidence in the medical profession and its systems of self-governance. A GP, for many years in single-handed practice and with a personal past history of drug abuse, Shipman had administered heroin to many of his elderly female patients.  He was convicted at Preston Crown Court in January 2000 of the murder of 15 patients, was sentenced to life imprisonment and later committed suicide.

In September 2000, the Secretary of State for Health announced an enquiry into the Shipman case would be held in public. Dame Janet Smith DBE, a High Court judge, was appointed chairman of the Shipman Inquiry and the work of the public inquiry began in February 2001. The estimate of the number of his victims rose (the sixth report reported that he had begun killing early in his medical career while in the hospital service). Comparison of his general practice's death rates with those of other practitioners, and examination of his records, suggested that there had been some 215 deaths. The Shipman report failed to recognise that Shipman could not have been caught by the GMC - but could well have been caught by restructuring of the Coroner Service and of the cremation certificate rules.  As a result, there was an onslaught on the regulation of the medical profession and massive reorganisation of the GMC - though the coroners' service and cremation rules did change as well.

Regulatory reform and revalidation - and the role of the GMC

Reform of the regulatory systems began.  The Royal Colleges, the BMA and its General Practice Committee, favoured 're-accreditation', the regular review of a doctor's work.  Surgical Colleges suggested that in future review surgeons might be reviewed by their peers every five years. The GMC  unanimously voted in 1999 for a system of continuing education and regular supervision of the standards of those in practice and issued a consultation document on Revalidating Doctors in June 2000. Under Sir Donald Irvine the GMC had begun to reshape itself to restore confidence. Irvine and the then editor of the BMJ Richard Smith  felt that a paternalistic profession and an inward looking system of medical regulation had dealt with only the most flagrant abuses.  Smith thought that one problem was that when there was a compromise between protecting people and being fair to doctors, the GMC sided with the doctors. Without reform the GMC might find itself abolished. There was opposition from some quarters of the profession.  There were no agreed standards, criteria or thresholds for 'serious professional misconduct' - difficult as appropriate medical care changes over the years. The GMC was prosecutor and jury, conflicting with the Human Rights Act 1998. The BMA and its own Central Consultants and Specialists Committee (CCSC) passed a motion of no confidence in the GMC in July 2000.  The GMC revised the way complaints were screened and handled to speed the process, and aimed to work more closely with the health service.   The Government went to consultation on reforming its structure and constitution, increasing the lay membership.  The Medical Act 1983 (Amendment) Order 2002  was made in December 2002, allowing for changes to the GMC constitution to include 14 lay and 21 medical members, and for new elections for a council to meet for the first time in July 2003. 

A system of regular appraisal and revalidation of all doctors in the NHS was agreed. The changes, outlined in A Licence to Practice and Revalidation, published in April 2003  make a  licence to practise a legal requirement for all registered doctors in the public or private sectors.

The fifth report of the Shipman Enquiry stated that the GMC had "fundamental flaws", criticized the reforms undertaken by the GMC as lacking sufficient rigour and said that in 3-4 years time the GMC should be evaluated.  If it was not operating satisfactorily by then, it should be considered whether the GMC functions should be undertaken by a different body.  The report made more than 100 recommendations. These included:  

• A telephone helpline for patients and health professionals to raise concerns about doctors' performance or conduct

• A central database of information about every doctor in the United Kingdom to which primary care trusts and employers would have access

• Improved monitoring of prescribed drugs

• The GMC to be accountable to parliament

• The GMC's constitution to be changed so it has more appointed members who are "not beholden to an electorate" and do not see themselves as representing doctors

• Patients to have the chance to refuse to be treated by a doctor who is subject to conditions.

Source BMJ 2005, 330, 10.

The GMC's system of revalidation was criticized as unlikely to do the job and it was put on hold by Government pending a further review. Sir Liam Donaldson, the government's chief medical officer, was asked to review the role of the GMC.  Published in July 2006 for consultation, he proposed

• introduce extensive changes in the structure, functions and governance of the GMC;
• remove the GMC’s role to adjudicate in fitness to practise hearings;
• create a new independent tribunal to hear fitness to practise cases;
• devolve some direct medical regulation to local level introduce a standard definition of a good doctor that would be incorporated into all NHS contracts;
• measure the risk of poorly performing doctors across diverse roles, working patterns and practice settings;
• change the management of under-graduate education;
• extend medical regulation to students;
• improve public access to well-managed, meaningful information about doctors.
• introduce specialist certification within a framework of revalidation, a well established process in the USA.

Based upon the consultation, the following February the Government issued a white paper Trust, Assurance and Safety, The Regulation of Health Professionals in the 21st Century  (Cm 7013)

The key proposals considered by a working group established by Sir Liam Donaldson that reported in July 2008  were

- professional regulators independent of Government and led by an equal partnership of independently appointed professionals and members of the public;

- all health professionals to demonstrate periodically that they are fit to practise by revalidating their professional registration; all doctors wishing to practice to hold a licence renewed every five years.

- moving from the criminal standard of proof to the civil standard with a sliding scale in fitness to practice cases;

- a stronger role for the medical Royal Colleges;

- a system of regional GMC Affiliates who will provide support to local employers in addressing concerns about doctors and independently quality assure local revalidation processes.

In general the proposals were accepted, with a view to implementation over the next three years. The General Medical Council would establish a programme board to support the development of revalidation processes anf consider the practical issues around implementation.

Professional regulatory reform in the UK: a brief chronology 1995 GMC publishes first edition of Good Medical Practice, setting out the duties of a doctor Medical (Professional Performance) Act 1995 passed, giving the GMC new powers to deal with problems of poor performance 1999. Health Act gives the government powers to reform professional regulation through statutory Section 60 orders without the need to pass new primary legislation Department of Health publishes Supporting Doctors, Protecting Patients, which calls for a fundamental review of professional self regulation and sets out 17 principles 2000. Medical Act (Amendment) Order approved allowing GMC powers to make interim suspensions, restricting restoration of erased doctors, and widening membership of conduct committees NHS Plan outlines the intent to establish a UK Council for Health Care Regulators for the formal coordination of professional regulatory bodies 2001. Bristol Royal Infirmary inquiry recommends creation of a body to oversee professional self regulation and Department of Health publishes proposals for such reforms in Modernising Regulation in the Health Professions General Social Care Council established through the Care Standards Act 2000 to regulate the social care workforce General Dental Council reforms its governance and structure and introduces plans to regulate other professions in the dental team such as hygienists, therapists, and technicians and to make continuing professional development mandatory 2002. Replacement of the United Kingdom Central Council as the regulatory body for nurses and midwives by the Nursing and Midwifery Council and replacement of the Council for Professions Supplementary to Medicine by the Health Professions Council. Passage of the NHS Reform and Health Professions Act 2002, creating the Council for the Regulation of Health Professions (CHRP) with statutory powers of oversight over the regulators. Medical Act (Amendment) Order 2002 approved enabling introduction of revalidation, new fitness to practise procedures, and changes in governance for GMC 2003. CHRP (now known as the Council for Healthcare Regulatory Excellence) established and starts its first work programme, including performance reviews of all regulatory bodies and development of guidance on how to use its statutory powers 2004. First referrals of some regulators' fitness to practise decisions to the Appeal Court on grounds of undue leniency. Appeal Court changes some decisions and refers some others back to the regulatory body for reconsideration. Introduction of regulation for operating department practitioners by the Health Professions Council. GMC introduces new fitness to practise rules with a single complaints process to replace separate conduct, performance, and health proceedings. Shipman Inquiry fifth report extensively reviews both old and new GMC fitness to practise procedures and criticises GMC for failing to protect the public and instead acting in the interests of doctors. Department of Health consults on proposals to establish a new regulatory body for complementary therapies, initially focused on acupuncture and herbal medicine. Department of Health consults on proposals to extend statutory regulation to all healthcare support staff (paralleling the regulation of social care workers by the General Social Care Council) 2005. Department of Health suspends adoption of new revalidation procedures by GMC and announces two reviews of medical and non-medical professional regulation 2007 Government publishes White Paper Trust, Assurance and Safety - the Regulation of Health professionals in the 21st Century, setting out plans for future regulation and followed by legislation. 2008 Report of the CMO's Working Party, Medical Revalidation - Principles and Next Steps Source:  Walshe K, Benson L   BMJ 2005; 330: 1504-6, GMC News, March/April 2008, DH website

Death Certification

The second and third reports of the Shipman Enquiry dealt with the police investigation, the system for death and cremation certification and for the investigation of deaths by coroners.  In 2004 government announced a new system of certification.  Each coroner's area would have a medical examiner playing key role in verifying the cause of deaths.  Deaths would be verified by a doctor, paramedic, or senior nurse, who will then complete a verification form. The doctor who had treated the dead person in the immediate past will issue a certificate of the medical cause of death. After that the medical examiner will seek information from the family and elsewhere to confirm the cause of death and authorise burial or cremation, without having to refer the death to the coroner.

Clinical Governance

In 1992 the Cadbury Report had identified principles of good governance in organisations, integrity, openness and accountability.  This was taken further in the Nolan Report (1997) and other subsequent management orientated documents.  Government saw clinical governance as a tool that would deliver quality.  It drew on the wide range of quality techniques and initiatives developed world wide over the previous years.  

‘Clinical Governance’ entered the NHS vocabulary.  The Commission for Health Improvement was charged with reviewing how far hospitals had implemented it.  Clinical governance seemed to involve corporate accountability for clinical performance, alongside the other managerial responsibilities.

An early definition A system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish. BMJ 1998; 317: 61-5

The purpose of clinical governance, according to the Commission for Health Improvement (2001) was to ensure that patients received the highest quality of NHS care possible and it covered the organisation’s systems and processes for monitoring and improving services, including:

• consultation and patient involvement
• clinical risk management
• clinical audit
• research and effectiveness
• staffing and staff management
• education, training and continuing personal and professional development
• the use of information about the patients’ experience, outcomes and processes

It should ensure

• continuous improvement of patient services and care
• a patient-centred approach that includes treating patients courteously, involving them in decisions about their care and keeping them informed
• a commitment to quality, which ensures that health professionals are up to date in their practices and properly supervised where necessary
• the prevention of clinical errors wherever possible and the commitment to learn from mistakes and share that learning with others

Clinical governance reflected a fundamental change in powers and responsibility of managers and consultants; consultants could no longer regard themselves as free-floating entities; trusts and consultants had mutual responsibilities.  However some saw the process as jargon-rich and progress was in any case slow.  After three years a report from the West Midlands Region suggested that while structures and systems were in place, as yet there was little real difference in clinical activities and attitudes. Walshe K, Scope to improve. HSJ 2000, 26 Oct, 30-1.  Ensuring adherence to National Service Frameworks, for example, required the collection of substantial quantities of data by GPs, appropriate computer systems and data entry.  Mandating quality through central initiatives had not been especially successful in other countries; was it likely to be more effective in Britain?  Inevitably implementation varied from place to place.  With good leadership, local projects to improve patient management might multiply, or it might seem removed from the day to day concerns of clinical staff and incapable of answering questions such as "how can we improve procedures for a normal delivery" 

Body parts retention

Pathologists who had, for decades had routinely kept blood specimens, histological slides and pathological preparations found that this practice was unacceptable to some, once it was public knowledge.  At Alder Hey Hospital, matters had gone further.  A report by Michael Redfern QC showed that a huge collection of organs had been built up without full parental consent being obtained, or in some cases even sought.  Sometimes organs, for example the thymus, had been 'harvested' and made available to pharmaceutical companies.  500 parents joined a legal action for compensation.  A related enquiry by the Chief Medical Officer, Liam Donaldson, showed that more than 105,000 body parts were stored in English hospitals and medical schools, half dating from more than 30 years previously.  This was no surprise to any British trained doctor, part of whose professional education had consisted of the study of preserved specimens showing the marks of disease, though at times the retention of organs had gone far beyond that required for bona fide research.  In April 2000, Mrs. Elaine Isaacs discovered that, without her knowledge or consent, the brain of her late husband was removed after a coroner's post mortem and given to Manchester University for research purposes. Following investigation Dr Jeremy Metters, Her Majesty's Inspector of Anatomy, concluded that the protocols for the research, between 1985-1997, did not take proper account of the Human Tissue Act or the Coroners' Rules.  New legislation was introduced to ensure that informed consent was obtained from patients or relatives.  

The costs of negligence

Each year the costs of settling legal actions for clinical negligence were rising. Constant pressure to put more people through the system, and old equipment in outdated buildings did nothing to improve quality.  Traditionally the costs of compensation had fallen on the individual clinician and his insurance, but it shifted first to the hospital concerned, and in April 2001 to the NHS Litigation Authority.    Much money went to very large compensation awards to provide long term care for badly damaged patients for example infants brain damaged at birth.  A substantial backlog of claims existed estimated by the National Audit Office to exceed £4 billion. The costs led Labour, in 2001, to review how compensation was handled, though the withdrawal of legal aid led to a plateau in claims. The Chief Medical Officer was asked to report and in June 2003 he published Making Amends. It was proposed that doctors would be under a duty of candour to report mistakes, there might be teams of investigators to assess claims, with a maximum of £30,000 compensation in most cases.  The right to legal action would be removed once compensation had been paid. 

Regulation

A consultation paper in the first year of Labour's administration, A first class service, (1998) heralded a positive shoal of related activities and new bodies. Government was becoming increasingly impatient with professional self-regulation, and the time taken by GMC procedures to come to a final decision.   High profile cases stimulated the introduction of new measures to monitor performance and to ban swiftly doctors who were dangerous and incompetent, challenging the medical profession’s traditional independence. Under the National Health Service Reform and Health Care Professions Act 2002 the government established the Council for the Regulation of Healthcare Professionals chaired by Jane Wesson, previously Chair of the National Clinical Assessment Authority (NCAA).  The  Council, which was called for in the Kennedy Report, would have members from the professions and others (in a slight majority) representing public interests and the NHS.  It would oversee

• General Chiropractic Council
• General Dental Council
• General Medical Council
• General Optical Council
• General Osteopathic Council
• Health Professions Council
• Nursing and Midwifery Council
• Pharmaceutical Society of Northern Ireland
• Royal Pharmaceutical Society of Great Britain

The Council decided to change its name to the Council for Healthcare Regulatory Excellence, because it would better reflect our role and purpose and avoid possible confusion with bodies of a similar name.  Government was becoming increasingly involved in the quality of services, anathema in the early years of the NHS.    It was also an issue in the White Paper, The new NHS - Modern - Dependable (1998), Labour proposing a statutory duty to provide high quality care. A raft of bodies now vied for the right to assess the quality of care.  The Commission for Health Improvement was followed by the Commission for Healthcare Audit and Inspection (CHAI). The National Audit Office and the Audit Commission had been involved for a while, and a range of new organisations was established. Organisations with a remit to pore over the workings of the NHS were proliferating.  There might be more people looking at the doing, than doing the doing..

Labour created five regulatory agencies The National Institute for Clinical Excellence The Commission for Health Improvement (successor body the Healthcare Commission) The Modernisation Agency The National Patient Safety Agency The National Clinical Assessment Authority

Types of quality programmes Whole organisations, e.g. total quality and continuous quality improvement programmes Collaborative teams in different organizations External review and accreditation programmes Changing practice, e.g. guidelines and national service frameworks National or local quality initiatives and strategies adapted from Øvretveit J & Gustafson D, BMJ 2003; 326:759-61

All were well resourced, most were ultimately accountable to central government, and they were part of a wider movement towards regulation and audit.  Because of the high salaries paid, they attracted staff from trusts and added to their burdens. They might duplicate their demands; for example both CHI and the National Audit Office checked out clinical governance, a situation remedied by the creation of the Healthcare Commission, (the Commission for Health Care Inspection and Audit) from April 2004.  As the number of organisations concerned with quality and regulation spiralled, the need for coordination became apparent.  In 2004 the main organisations involved came together and agreed a Concordat aimed at bringing order to the chaos.

Characteristics of the five NHS regulators created by the British government between April 1999 and April 2001
Source :Kieran Walshe, The rise of regulation in the NHS. BMJ 2002;324:967-970
Name	Who it regulates	Date established	Annual budget (£)	Mission or purpose	How it works	What it is
National Institute for Clinical Excellence (www.nice.org.uk)	NHS in England and Wales	Apr 1999	10.6m (2001-2002)	To provide patients, health professionals, and the public with authoritative, robust, and reliable guidance on current "best practice"	Uses teams of experts to review health technologies and interventions and produce guidance which is then disseminated	A special health authority, set up by statutory instrument (SI 1999 Nos 220 and 2219)   Name changed to National Institute for Health and Clinical Excellence.
Commission for Health Improvement	NHS in England and Wales	Nov 1999	24.5m (2001-2002)	To help improve the quality of patient care by assisting the NHS in addressing unacceptable variations and to ensure a consistently high standard of patient care	Undertakes clinical governance reviews of all NHS organisations every 4 years; monitors implementation of guidelines from NICE, national service frameworks, etc; investigates major system failures within the NHS	A non-departmental public body established by the Health Act 1999.  Subsequently the Healthcare Commission.
Modernisation Agency abolished in 2005 after the Arms Length Bodies review	NHS in England	Apr 2001	54.6m (2001-2002)	To help the NHS bring about improvements in services for patients and contribute to national planning and performance improvement strategies	Encompasses existing national patient action team; primary care development team; collaboratives programme; leadership centre; beacon programme; and clinical governance support unit	Part of the Department of Health and abolished.
National Patient Safety Agency (www.npsa.org.uk)	NHS in England (at present)	Jul 2001	15m (2002-2003)	To collect and analyse information on adverse events in the NHS, assimilate safety information from elsewhere, learn lessons and feed back to the NHS, produce solutions, set national goals and establish mechanisms to track progress	Will establish and operate a new, mandatory national system for reporting adverse events and "near misses," and provide national leadership and guidance on patient safety and adverse events	A special health authority set up by statutory instrument (SI 2001 No 1743)
National Clinical Assessment Authority, subsequently merged into NPSA	NHS in England (at present)	Apr 2001	10.1m (2002-2003)	To provide a support service to health authorities and hospital and community trusts who are faced with concerns over the performance of an individual doctor	Deals with concerns about doctors in difficulty by providing advice, taking referrals and carrying out targeted assessments where necessary	A special health authority set up by statutory instrument (SI 2000 No 2961).  Merged in 2005 with the National Patient Safety Authority.

  

Government proposals attempted to do two things, not necessarily compatible.  First the 'person' approach, looking for individual errors; second a system approach looking at the entire system and introducing risk management, memory aids, and the reporting of problems to ensure their rectification.  The regulatory bodies equally might follow either a sanction driven approach, or might attempt to stimulate development on the assumption that most bodies were essentially well-meaning, and would improve their performance given the chance.

National Clinical Assessment Authority (NCAA),

The NHS Plan of July 2000 established a National Clinical Assessment Authority (NCAA.)  in April 2001, separate from the Department of Health, as a Special Health Authority and proposed a supervisory body to oversee professional regulatory bodies.  NCAA operated on a confidential basis, bringing expert support and advice to situations where doctors' performance was being questioned.   Cases could be referred to NCAA by an employer or by the doctor personally.  If a problem could not be resolved locally, NCAA would undertake its own assessment, report on the action that might be taken and monitor what then happened.   The roles were

• NCAA assesses the contribution of individual doctors to the local service by addressing individual performance issues;

• The GMC investigates serious misconduct, health or performance issues of individual doctors which may call into question the doctor's fitness to remain on the medical register.

• CHI assesses clinical governance in all NHS organisations, and will review systems in health authorities and trusts for identifying and handling poor performance. CHI also investigates when there are serious system failures;

In 2005 the NCAA became part of the National Patient Safety Agency.

National Patient Safety Agency

Building a safer NHS for patients (2001) put an emphasis on reporting adverse events and risk reduction.  The independent National Patient Safety Agency (NPSA) was established in July 2001, a 'mandatory system for logging all failures, mistakes, errors and near-misses across the health service'  to feed lessons learned back into practice, and work alongside the Commission for Health Improvement, later the Healthcare Commission, and the Clinical Governance Support Team. In 2005 the Agency expanded to incorporate the National Clinical Assessment Service and the National Research Ethics Service.  It also took over the funding of three Confidential Enquiries into: Suicide and Homicide, (hosted by the psychiatry division of Manchester University Medical School, Maternal and Child Health, (hosted by the Royal College of Obstetricians and Gynaecologists) and Patient Outcome and Death (a charity and limited company representing Royal Colleges).

The National Institute for Clinical Excellence (NICE)

When the NHS was established in 1948, its clinical standards were those of individual clinicians and their professional organizations. If the emerging NHS had tried to challenge the traditional freedom of clinicians, the medical profession would have walked away from it.  Attitudes changed. Medical practice based on evidence, rather than on anecdote and opinion, gained credence. Studies during the 1990s showed that the results of clinical research were poorly incorporated into routine care and that inappropriate variations in the standards of clinical practice abounded.  As part of the 1998 Comprehensive Spending Review officials were asked to look at ways of improving efficiency and effectiveness in the NHS.  The report proposed a systematic and national approach to the appraisal and management of new technologies.  The White Paper, The New NHS (December 1997), announced the establishment of a new National Institute for Clinical Excellence, with a remit to include guidance on drugs and other technologies. NICE profoundly changed the way that England and Wales evaluated health interventions, for the better.  Established in April 1991 it brought together a number of organisations that worked on quality.

Its initial functions were

• appraising new technologies, including drugs, and from 2003 to assess whether interventional procedures used for diagnosis or treatment were safe enough and worked well enough for routine use in the NHS.

• deciding which should be encouraged in the NHS, and which should be held back.  

• producing or approving clinical guidelines (for example on GP referral to hospital)

• identifying ways of improving the quality of care, and encouraging quality improvement

• *funding the four confidential enquiries into maternal deaths, stillbirths and deaths in infancy, perioperative deaths, and suicides and homicides by people with mental illness.

[*These studies were later transferred for funding to the National Patient Safety Agency.  Two were amalgamated into CEMACH in 2003 – the Confidential Enquiry into Stillbirths and Deaths in Infancy (CESDI) and the Confidential Enquiry into Maternal Deaths (CEMD).   The study into Peri-Operative Deaths continued within NCPOD, and the National Confidential Inquiry (NCI) into Suicide and Homicide by People with Mental Illness operated under the aegis of Manchester University.]

NICE was established as a Special Health Authority (therefore accountable to the Department of Health.)  It stood at the controversial intersection of quality, innovation, access, reduction of practice variations and cost, with a remit to operate in an open way and to deal with clinical and cost uncertainties. Initially a small organisation chaired by Sir Michael Rawlins, within two years, often by contracting work out, it had issued 22 reports.  By April 2005  the number had risen to 86, often important to specific but small groups of patients.  NICE did not accept or reject health care technologies on cost effectiveness grounds alone, although this was a major factor, and operated to a set of principles. However above £30,000/quality adjusted life year (QALY) the case for supporting the technology had to be increasingly strong - draft guidance rejecting drugs for kidney cancer was issued on this ground (2008). Some criticised the threshold as too low, excluding some treatments; others that it was too high, with the result that the health service had to economise on forms of care that were possibly more worthwhile, but had not been mandated by NICE.

Steadily NICE's credibility grew, it came in some part to replace the National Service Frameworks and it became a major feature of the landscape of clinical medicine.  Its guidelines were increasingly welcomed, and its work began to achieve international recognition. Internationally, NICE was unusual in having a formal appeals process. In 2004 a review of arms' length bodies recommended that NICE should take over the the public health functions of the Health Development Agency.  From 1 April 2005  it became the National Institute for Health and Clinical Excellence (still known as NICE), an independent organisation responsible for providing national guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.

Regularly government would suggest new  groups of drugs and procedures for assessment, usually of new procedures, rather than existing patterns of treatment. The reports fell into several main categories:  ( Bosanquet N, Health Service Journal, 19 June 2003, p 30-1)

• Cancer treatment and chemotherapy

• Heart disease

• Surgery, laparoscopic and orthopaedic

• Lifestyle drugs, smoking and weight reduction

• Central nervous system and mental illness including Alzheimer

• Long-term conditions, rheumatoid arthritis and renal disease. 

In September 2006 NICE was asked to launch a new programme to help the NHS identify interventions that are not effective, to help the NHS make better use of its resources by reducing spending on ineffective treatments, that did not improve patient care or represent good value for money.  Technology appraisals would be undertaken where clinical evidence suggested that current practice is no longer appropriate or effective and does not improve patient care. For example, a clinical guideline could be developed on how to manage sore throats in children. Antibiotics are known to be largely ineffective, for example they will not work if it is a viral infection. NHS could then invest in drugs and approaches to care that make a positive difference to patients’ lives

An early aim was to end ‘postcode prescribing’ where treatment was determined by local decision and place of residence.  In October 2001 government decided that the NHS should be compelled to implement the recommendations.  NICE decisions were made without consideration of  budgetary constraint. Zyban and other anti-smoking devices were likely to cost an additional £50 million/year and a drug to treat hepatitis C £18 million. Courses of in-vitro fertilisation, free for women between 23-39, also had major cost consequences.  Most recommendations suggested routine use of technologies, or accepted them with major or minor restrictions. In 2002 the NICE estimated that its guidance could increase costs to the NHS in England and Wales by about £575 million, and in 2007 by £1.6 billion.  Prescribing costs in general practice rose at 10% per year or more, substantially as a result of NICE recommendations.  Its guidance was in theory mandatory for the NHS so sometimes the choice was to cut services or fund the recommendations. There was anxiety that the treatments that Trusts had to cut might have, in fact, a higher QUALY than those NICE approved and which became mandatory.  While the government set up systems of monitoring compliance, in many cases, particularly when costly treatment was involved, primary care trusts refused payment, and the post-code lottery persisted.

Controversy was never far from the surface.  NICE early ran into dispute over the flu drug Relenza and beta interferon for multiple sclerosis.   In 2006 Pfizer and another company took court action over its decision to restrict access to dementia drugs to those at a moderate, not an early stage, seeking a judicial review of how the NICE reached its conclusions.  The Court supported the process by which NICE came to its conclusion.  NICE was responsible for delayed use of some new drugs; it did not approve atypical anti-psychotics until 2002, ten years after they had entered clinical practice.   It probably increased  the dissemination of some technologies judged cost-effective, e.g. taxanes, but there was less compliance with other recommendations, for example new drugs for arthritis and schizophrenia.  It was less successful in discouraging the use of drugs thought not to be cost effective.  Neither was it clear that when changes had occurred, it was the result of the guidance rather than manufacturers' marketing efforts. While denying that it was rationing health care, others contended that prioritization inevitably meant this.  In the absence of detailed knowledge of individual patients only general guidance could be given - while it was individual patients that received or did not receive treatment.  NICE inevitably had to consider treatments one at a time and not necessarily the whole range of alternatives available. 

The method by which its appraisals were conducted was sometimes criticised, as by the House of Commons health select committee in January 2002.  NICE rejected such adverse comments but the Committee's report called for a move away from isolated technological appraisals towards broader guidance, and more willingness to work with others when making clinical assessments.  NICE asked the WHO Regional office for Europe to conduct a review of  technology appraisal programme. The review was largely supportive, although there were comments on the difficulty in reconciling openness of decision-making and the use of commercially confidential material provided by  the pharmaceutical industry.

Initially the Chairman said it was not the Institute's role to veto drugs that, though expensive, had clinical benefit. Progressively cost/benefit entered the equation, 'whether a drug was effective use of NHS resources' and cost-benefit criteria were used.  This led to increased criticism of its decisions.  For example a drug to help smokers give up was approved, when some cancer chemotherapy drugs were not. However NICE did not try to work within a budget for NHS drugs - affordability to the NHS was a matter for government.  NICE had criteria other than cost and cost-effectiveness, including encouragement of innovation and the broad clinical priorities of the NHS.  It had to make scientific judgments on what was good or bad, and social value judgments on what was good for society, in which it was assisted by a Citizens Council. 

Scotland, with its greater health funding per capita, made drugs available more rapidly. NICE also appeared to take its time in making assessments, and was criticised for its delays and decisions on Tarceva (lung cancer), Velcade (multiple myeloma), Alzheimer's drugs, Alimta (mesothelioma) and Gliadel (brain tumours).  NICE was itself under financial constraints; its budget was reduced in 2005 and one of the three committees undertaking assessments was scrapped.  This increased the time it took to approve drugs, for example new ones used in breast and colon cancer. While doctors could prescribe drugs licensed by the Medicines and Healthcare Products Regulatory Authority (MHRA), in practice it was rare to get NHS funding in advance of  a NICE recommendation.

NICE exists to give health professionals advice on providing their NHS patients with the highest clinical standards of care It undertakes its economic assessments using a cost utility approach (cost per quality adjusted life year) Decisions about cost effectiveness are made on a case by case basis Judgment is needed to balance the tensions between efficiency and equity       Rawlins M & Culyer A J BMJ 2004; 329: 224-7

In January 2008 the House of Commons Health Select Committee published its second report into NICE, six years after its first.  The committee questioned the financial threshold used by NICE, suggested that appraisals should appear at the time of drug launch, not long afterwards, and was concerned about the quality of data used, much of which was derived from the drug industry.

The Commission for Health Improvement

Until the establishment of the Commission for Health Improvement (CHI), independent inspection of NHS hospitals was largely unknown, unlike the situation in the USA where there was a lengthy tradition and substantial experience. CHI was established in April 2000 to undertake a rolling programme of provider and service reviews.  Kenneth Robinson had established the Hospital (later Health) Advisory Service in the sixties in the wake of scandals in long term care but it had neither the scope nor size of CHI.  CHI was immediately asked to investigate problems in two trusts in Cumbria and the Carmarthenshire in Wales.  The hard hitting reports established its position as a trouble-shooter and the classic ingredients, a whistleblower, a culture of secrecy and previous internal enquiries that had failed to bring about sufficient action. There was a tension between the role imposed by government as a watchdog with a punitive function, reviewing every Trust and the concept of a catalyst promoting continuous quality improvement.  The staff and budget of CHI increased fast. By 2002  as many as nine reports might be published in a single week.   CHI attempted to assess the processes of care and the way the organization operated, but assessing the quality and outcome of care was harder. The role of CHI was diagnostic.  The follow-up of recommendations was for others, and it had no power to enforce its recommendations.

CHI was not independent of the Department of Health.   Professor Ian Kennedy's report on the problems of paediatric heart surgery at Bristol later recommended that it should be and Government accepted this proposal.  The NHS Reform and Healthcare Professions Act (2002) tried to rationalize inspection, gave CHI a wider role and greater independence, and the responsibility for the private health sector through the National Care Standards Commission, initially a separate organization.  It required the commission to publish information on performance and from 2003 made CHI responsible for the star ratings system (previously calculated by the Department of Health) comparatively free from government intervention.  The star rating system and the number of hospitals in each band was, however, highly subjective.  Drawing on its experience of visits, in 2003 CHI published a report, Getting Better? a report on the NHS, identifying such problems as infection control, too great a concentration on waiting lists, and a lack of doctors in management positions.

CHI relied heavily on the professional expertise of its teams, rather than explicit standards. It had been directed to study "clinical governance" and this largely focused on process issues rather than patient care per se.  The reviews led to much trust activity in the years before and after; then rather less.  The follow up was for others, regional offices or strategic health authorities, so the feedback loop was not complete.

Healthcare Commission

In April 2002, the government announced plans for a new Commission for Healthcare Audit and Inspection (CHAI)  with greater powers, to subsume the existing Commission for Health Improvement, the value-for money-responsibilities of the Audit Commission and those of the National Care Standards Commission (concerned with licensing private health care and only in operation for three weeks). "I" now stood for inspection, rather than improvement. CHAI would have four roles, setting standards, audit and inspection of performance, clinical governance and finance, improvement (alongside the Modernisation Agency itself now living on borrowed time) and enforcement, working with strategic health authorities.

It seemed natural that the chairman should be Professor Sir Ian Kennedy, the author of the Bristol report. It was rebranded as  the Healthcare Commission.  The new regulator would inspect all health care providers – public and private – against "uniform, clear and comprehensive standards". and there was a clean break between the old and the new organisations.  Peter Homa, the chief executive, resigned as the new chairman rethought the way the organisation would function. The Healthcare Commission, reporting in July 2004, said  that the 'inverse care law' of Julian Tudor Hart (Lancet 1971; 1:405-12) still held sway.  Those most needing care were least likely to receive it. An ambitious undertaking for so young an organisation, the report profiled several issues, such as the care of ethnic minorities, children, and the elderly.

The Commission wished to rationalise the overlap between organisations responsible for healthcare inspection to provide a more coordinated approach to visits and requests for information. Sir Ian wished to make visits more targeted and more proportionate.  The Healthcare Commission published the star ratings in 2004 for hospitals, primary care and mental health care trusts.  Sir Ian wished to move from inspection, an expensive and not necessarily reliable tool, to regulation based upon data - information derived from a multitude of sources.  He wanted the information to come from trusts themselves. This would be supplemented by visits, sometimes as a result of the information received, but others random in nature.  A new system based on "core standards" was introduced, using seven topics, safety, clinical and cost effectiveness, governance, patient focus, accessible and responsive care, the care environment and amenities, and public health. Trusts assessed and self-certified how far they met these standards, and the separate and defined elements of each. Kennedy regretted that it had not been possible to assess pathways of care and the outcomes achieved, to design a system that was prospective rather than retrospective (to identify problems as they were arising) or to incorporate patient experiences adequately.

The first new annual "health check" ratings appeared in October 2006 and annually in 2007 and 2008. They painted a mixed picture of the quality of services in the NHS. The score for quality covered areas that mattered to patients, including safety, cleanliness and effectiveness.

Sir Ian had disputes with government and in November 2006 the Department consulted on a proposal to merge three organisations, the Healthcare Commission, the Commissions for Social Care Inspection and the Mental Health Act Commission) into the Care Quality Commission (CQC)  Legislation was announced to create the new regulator "to ensure clean and safe services, and high quality care."  It would have the power to instigate a statutory warning notice demanding improvements, a formal caution, a temporary suspension of mandatory registration, conditions restricting what can be provided or criminal prosecution.  Baroness Young (Barbara Young) was appointed Chair.

In February 2008 the organisation of clinical audit, previously undertaken by the Commission, was awarded to a consortium  of the Academy of Medical Royal Colleges, the Royal College of Nursing and the Long Term Conditions Alliance to be known as the Healthcare Quality Improvement Partnership. It would support a newly created National Clinical Audit Advisory Group (NCAAG), set up to provide advice and guidance on the overall programme of work, and to consider proposals for new audits or for discontinuing existing audits.

Medical Progress

Paragraphs include

Acute and chronic diseases	Ophthalmology
Public Health,	Cancer
The drug treatment of disease	Obstetrics and Gynaecology
Radiology and diagnostic imaging	Paediatrics
Infectious Disease & immunisation	Geriatrics
Surgery	Mental illness
Fast track & minimally invasive surgery	Alternative medicine
Orthopaedics and trauma	Emergency medicine
Cardiology and cardiac surgery
Organ Transplantation
Neurology & neurosurgery
Medical genetics

Changing clinical practice

Since the earliest years of the NHS clinical innovators, leaders of the medical profession, government and NHS management had tried to spread good practice and ensure that everyone had access to high quality and up to date care. Government had supported the professions often by establishing a professional sub-group under the Standing Medical Advisory Committee and then commending its proposals.  In the seventies both the Conservatives and Labour had issued a range of proposals to improve clinical services, for example Better Services for the Mentally Handicapped (1971)..SMAC and SNMAC were abolished in 2005.   A new mechanism involved national strategies and  National Service Frameworks  (NSFs) which  "set national standards and defined service models for a specific service or care group, put in place programmes to support implementation and established performance measures against which progress within an agreed timescale will be measured".  

NSFs were issued in September 1999 for mental health and for coronary heart disease in March 2000.  More followed.  As the number grew, they moved away from centrally driven targets towards the identification of good practice.  Experienced and senior clinicians were appointed to central positions of responsibility.  The Chief Medical Officer had previously chosen consultant advisers and the medical staff of the Department of Health had developed close links with them.  But as the Department's Medical Division shrank, Health Directors, or "tsars" were appointed to drive clinical policies in cancer, heart disease, mental health, older people's services, primary care, children, emergency access and patients' issues. These National Clinical Directors came to influence clinical policies and in 2006/2007 were asked to publish a series of papers, the "Clinical Case for Change" as part of Lord Darzi's programme.

Acute Diseases

Advances in the management of serious acute conditions, such as heart disease and stroke, influenced the pattern of the hospital service.  If the best treatment for a heart attack was early coronary angioplasty (commonplace in the USA for ten years), patients needed direct admission to a unit capable of performing this.  Similarly, a specialist stroke unit with scanning facilities and clot-busting drugs 24/7 might reduce ultimate dependency.  Such units could not be provided in every DGH - they might need a base population of a million, making a case for major regional units.  Reconfiguration of hospital services along these lines was given impetus by the reports from Prof.Sir Ara Darzii, the National Advisor on Surgery.  His report on the future of planned surgery, 'Saws and Scalpels to Lasers and Robots - Advances in Surgery', said that 80% of all surgery should be done locally with the remaining 20% of the more complex cases at specialist centres with access to the highly skilled surgeons and the most up to date technology. This might include complex cancer surgery, surgery of blood vessels, transplantation, removal of brain tumours and open heart surgery

Chronic Diseases

Increasingly health services were concerned with chronic diseases. Improving their management and reducing the many admissions for which such diseases were responsible became a high priority for government and led to an examination of the methods adopted by US managed care organisations. Routines developed to handle acute illnesses were ill suited to chronic diseases.  Two new approaches were tried in the UK, disease management and the chronic care model.

"Disease management", a concept from the USA, was provided by large companies unrelated to doctors' practices, paid by health insurers.  They used sophisticated information systems to identify patients with chronic diseases and establish close communication with them, educating them and their families on self-care, tracking their progress and intervening if problems seemed likely to arise. The pharmaceutical industry was interested in diseases requiring long term medication. In theory systematic, integrated evidence-based care of chronic high cost diseases such as asthma, rheumatoid arthritis and diabetes might be more effective. However, the management of specific diseases by a separate organisation risked the fragmentation of care, as patients with multiple unrelated pathology might be directed to specialised units.  The chronic care model, in contrast, was based within the doctors' practices, reorganised to create informed patients with self-management skills, and developing multidisciplinary teams to monitor patients at risk. (Casalino JAMA.2005; 293: 485-488.)

Public Health

Immunsation

Infectious disease

Factors affecting premature death.

Health is influenced by  genetics, social circumstances, environmental exposures and behavioural patterns.  Medical care has a relatively minor role in reducing early deaths. The single greatest opportunity to improve health and reduce premature deaths lies in personal behaviour. Obesity and physical inactivity combined are the top two behavioural causes of premature death.  (We Can Do Better — Improving the Health of the American People, Steven A. Schroeder, NEJM 2007, 357; 1221-1228 )  It was here, and on smoking, that effort was concentrated. Department of Health economists had difficulty in assessing the balance between spending on health promotion and health care services.  There was some resistance to rigorous application of cost-effectiveness frameworks to favoured interventions.  Nevertheless a range of preventive programs that seemed cost effective included universal 'flu vaccination for the over 65s, statin therapy to middle-aged people with coronary heart disease or who were at high risk, screening for Chlamydia infection, and nicotine replacement and increased support for counselling for smokers wishing to stop.

Health Inequalities

On election in 1997 Labour had promised a new strategy to break the cycle of  ill health due to poverty and deprivation. A mind-numbing series of reports appeared.  They were lengthy, repetitive and because of the compromises necessary to avoid encroaching on private liberty, were more radical than some wished, and less prescriptive than others would have them.

The Acheson Inquiry (1998)
Saving Lives - our healthier nation (1999)
Tackling Health Inequalities - A programme for action (2003)
Wanless - Securing Good Health for the Whole Population (2004)
Choosing Health (2004)
Health Inequalities; progress and next steps.

Acheson Inquiry

Labour commissioned an inquiry into inequalities in health in 1997, conducted by Sir Donald Acheson, an unusual choice as he had been CMO at the time when The Health of the Nation was prepared under the previous administration. The inquiry team, composed of scientists but no economist, based their recommendations on published evidence.  Because of evidence that the poor generally lived shorter unhealthy lives, the key recommendations involved a wholesale redistribution of wealth. The difference between the mortality rates of Social classes IV and I for stroke, heart disease, accidents and suicide were, if anything, widening.  Unlike the recommendations of the Black Report (1980), Acheson’s 1998 recommendations were not costed.  Sir Donald wanted to see the package implemented as a whole. ‘The inquiry had not looked at cost effectiveness’, he said, ‘affordability is not a matter for scientists but politicians…’  Some recommendations were vague, for example the need to take ‘measures to prevent suicide among young people’ or ‘policies to reduce fear of crime and violence’.  Sir Donald had asked an evaluation group to look at the quality of the evidence it used to reach its conclusions and support its recommendations. For most there proved to be no high quality controlled studies showing that the recommendations would improve health - there were few randomised-controlled trials available – but hard evidence of effectiveness has seldom underpinned changes in health policy.  Indeed at least in the US education was a powerful predictor of mortality, far more than income inequality (BMJ 2002;324: 1-2) 

Saving Lives - our healthier nation

This reviewed the 1992 Health of the Nation initiative and found that it had failed to change spending priorities and had made no significant impact on health authorities, trusts or GPs.  In 1999 Labour published a revised programme as a Green Paper, Our Healthier Nation, then a White Paper, Saving Lives - our healthier nation. This aimed to improve the health of everyone, particularly the worst off, taking into account the social, economic and environmental factors affecting health.  It reduced the number of health improvement targets to four and re-iterated the contributions to health of social, economic and environmental factors, and the individual decisions taken by individuals and their families.  The document expressed aspirations and tended to say what government could do - and not what it would do.  The role of the Health Visitors would be strengthened, and educational programmes would be introduced, for examine sessions at school to help children to avoid accidents. The new policy was not substantially different from the old one, though  the goal was now to improve the health of the worst off in particular.

Tackling Health Inequalities

In July 2003 Tackling Health Inequalities - A Programme for Action  set out a three-year plan on health inequalities. It aimed to meet the 2010 national health inequalities target on life expectancy (by geographical area) and infant mortality (by social class) and was organised around four themes, supporting families, mothers and children to break the inter-generational cycle of health; engaging communities and individuals to ensure relevance, responsiveness and sustainability; preventing illness and providing effective treatment and care; and dealing with the long term underlying causes of health inequalities.

Wanless

In his first report to the Treasury, largely concerned with financial matters, Derek Wanless had provided 3 different scenarios based on different levels of involvement of the public in relation to their health. Economic analysts within the Department of Health had a substantial input to these scenarios.  In April 2003 he was asked to provide an update on the challenges involved, focusing on prevention and the wider determinants of health. Two issues emerged again, regulation versus patient education, and local versus national projects. He issued a report on population health trends in December 2003 and his final document, Securing Good Health for the Whole Population, appeared in February 2004. Wanless thought the costs of the health service would be massively less if  there was "full engagement" - i.e. energetic and effective action by all concerned, including individual people.  Wanless drew attention to the problems of smoking, lack of activity and obesity, while failing to make clear what the costs would be incurred if individuals avoided life-style induced illnesses, and died later of something else instead.  
Recommendations

Key points included

•  Individuals are primarily responsible for their own health and lifestyles, but lack of information and the social context in which they live may lead to people failing to achieve the substantial improvement in health possible. These failures must in part be addressed by government

•  There had been much written, often covering similar ground and apparently sound, but rigorous implementation of identified solutions had often been lacking.

•  There is generally little evidence about the cost effectiveness of public health policies in part caused in part by lack of research funding.

•  This has led to the introduction of a wide range of initiatives, often with unclear objectives and little quantification of outcomes 

That led to a consultation document and a further White Paper, Choosing Health..  Increasingly the role of the individual was emphasized in the making of healthy lifestyle choices.

Choosing Health

Published in November 2004, the principles were informed choice (with the protection of those too young to choose, and ways of ensuring that one person's choice did not harm others), tailoring proposals to the reality of individual lives, and working together.  Among a myriad of actions to make the NHS a health promoting organisation, Choosing Health proposed

• action to increase the number of smoke-free workplaces

• Curbs on the promotion of unhealthy foods to children

• Clear, unambiguous labelling of the nutritional content of food

• better provision of information to the public, e.g. a 'Health Direct'

• NHS Health Trainers to provide advice to individuals on how to improve their lifestyle

Health Inequalities; progress and the next steps.

Attending the launch of Health Inequalities; progress and next steps (June 2008) Alan Johnson, supported by Sir Michael Marmot, made clear his commitment to long terms plans addressing inequalities.  He described the drop in life expectancy by one year at every tube station going east on the Jubilee line from Westminster to Canning Town. While the health of the poorest had improved significantly, the health gap remained.

There would be a ban on smoking in most public places such as pubs and restaurants, and in February 2006 the House of Commons on a free vote went further, for a near total prohibition.  There would be restriction of  TV advertising before 9 p.m. of high calorie junk foods and provision within primary care health of education on lifestyle.  The plan was criticized because there was little new about patient education, the timescales were long and reliance was sometimes placed on self-regulation by industry.  PCTs in the more deprived areas would, however, receive extra money to pilot such initiatives as health trainers (local people advising others on healthy living).  But the financial crisis of the NHS in 2006 led many PCTs to use money intended for Choosing Health to reduce the deficits that government said was their highest priority.

The Health Development Agency

The Health Development Agency, established in 2000 as a special health authority, was the successor to the Health Education Council (1969-1987) and the Health Education Authority (1987-2000)  It aimed to develop the evidence base to improve health and reduce health inequalities. It worked in partnership with professionals and practitioners across a range of sectors to translate that evidence into practice.  It too succumbed as a result of the Department of Health's 2004 review of "arms length bodies", and its functions were transferred to NICE on 1 April 2005. Speaking in Nottingham on Public Health on 26th July 2006, the Prime Minister, Tony Blair, said that the role of government was to enable and help people to act with responsibility.  Referring to the problem of obesity, smoking levels, drinking habits and diabetes, he pointed out that "these individual actions lead to collective costs."

Organisation of public health

Repeated changes in the organisational structure created problems for public health as the boundaries  seldom matched those of local authorities boundaries. Until 2001 most public health doctors worked on the “purchaser” or “commissioner” side, and a few as epidemiologists in hospital trusts.  Each Authority had a Director of Public Health sometimes with other roles such as Director of Health Strategy and usually with support from other consultants and trainees. 

April 2002 completed the move to Primary Care Trusts, exacerbating the problems of public health as a discipline.  Primary Care Trusts were essentially built upon general practitioner registered populations rather than a defined geographical area, and the large number of PCTs, each of comparatively small size, posed problems for public health.  Later, an attempt was made to align many PCTs with local authority boundaries.

As regions were abolished and regional outposts were integrated into the Department of Health, Regional Directors of Public Health became civil servants.  "Observatories" were created to report on the problems at regional level by the analysis of statistical data.  In parallel non-medical staff concerned with public health, e.g. health visitors, health educators and environmental officers, became eligible for membership of the Faculty of Public Health and the government decided that the post of Director of Public Health did not require a medical qualification.  Public health was changing, as it progressively ceased to be largely a discipline for doctors who had received the additional training necessary, and came to incorporate non-medical disciplines that had always made a substantial contribution to the subject, such as epidemiologists, economists and statisticians amongst others. Simultaneously, medical management positions that previously had often gone to those with public health skills, were increasing occupied by clinicians.

9 Regional Public Health Groups were ultimately formed to match the strategic health authorities and were part of the Department of Health, co-located in each of England’s nine Government Offices.  They worked alongside public health colleagues in NHS, local authorities and other agencies to improve and protect their local population.   The Association of Pubic Health Observatories drew together public health intelligence from across the UK and Eire.  It provided the NHS with expertise in fields such as alcohol and drug misuse, and diseases such as stroke, cancer and sexual health.  It produced health profiles for every local authority in England. 

The drug treatment of disease

An increasing number of expensive but clinically effective drugs, sometimes "life-style" in nature, were introduced.  Prozac, HRT and Viagra might improve qualities of life to which medicine had previously paid less attention.  In January 2001 NICE approved three new drugs for the treatment of mild or moderate Alzheimer's disease.  A new anti-obesity drug, Xenical, offered an alternative approach to a common problem by reducing fat absorption; NICE agreed in March 2001 that it could be prescribed under the NHS when patients were motivated to lose weight, obesity was significant and was posing a threat to health. In April 2002 it recommended the use of bupropion (Zyban) and nicotine replacement therapy (NRT) for smokers who wished to quit.

Expensive yet effective drugs also appeared for common conditions, e.g. for cancer and for coronary artery disease and stroke. Statins represented the largest drug cost to the NHS (£1.1 billion in 2004) though the cost of simvastatin fell greatly when out of patent.  Herceptin achieved a major reduction in the recurrence rate of an aggressive form of breast cancer in those with the HER-2 gene - but cost £20,000/year. Adults with diabetes of the insulin resistant type stood to benefit from a new class of drugs, the thiazolidinediones.  Organ transplantation became more reliable with the development of new immune-suppressors. The treatment of benign prostatic hyperplasia, a common condition, was improved by combination therapy with doxazosin and finasteride which reduced the risk of acute urinary retention and the need for surgery.

A new group of drugs derived from monoclonal antibodies began to appear.  Infliximab (1998), an artificial antibody, was introduced for autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylits and psoriasis.  It worked by blocking tumour necrosis factor alpha (TNFα). TNFα is a chemical messenger (cytokine) and a key part of the autoimmune reaction. Infliximab blocks the action of TNFα by preventing it from binding to itsreceptor in the cell.

Drug safety

The examination of drugs for safety and efficacy in the UK had a history back to the thalidomide disaster in the 1960s. Within the EC the European Medicines Evaluation Agency brought together the resources of European Community members and was based in London.  In April 2003 the Medicines Control Agency (MCA) was merged with the Medical Devices Agency (MDA) as the Medicines and Healthcare Products Regulatory Agency, (MHRA), a role similar to that of the FDA in the USA.

Not all the new drugs proved safe either before or after public release.  In 2006 at the clinical trial stage, the testing of a monoclonal antibody TGN1412 in a unit at Northwick Park Hospital led to multi-organ failure simultaneously in 6 young men; all survived but some suffered permanent injury.  While reporting systems made it possible to spot increased numbers of rare events, such as liver failure, a raised incidence of a common problem, for example heart attacks, was harder to discover. A new anti-depressive, Paroxetine (Seroxat) seemed to be associated with a raised incidence of suicidal thoughts and suicide. Cox-2 inhibitors were introduced  in 1999 for the the treatment of arthritis in the hope that gastro-intestinal side effects would be less common.  They received massive publicity, often direct to consumer, and combined sales exceeded $5 billion annually. Over a 5 year period, evidence emerged of higher risk of heart attacks and stroke and this appeared to be an effect of all drugs in that class. In September 2004 Merck withdrew rofecoxib (Vioxx ) from the market.  The belief that the Company had not drawn attention to early indications of problems led to Court actions and substantial awards.  Pfizer also withdrew Celebrex (celecoxib), there being well established alternatives for the treatment of all the approved indications for their use. (Drazen J M, NEJM 17 March 2005)

Off-label prescribing

The prescription of a medication in a manner different from that approved was legal and common, often in the absence of adequate supporting data. Off-label uses had not been formally evaluated and evidence provided for one clinical situation might not apply to others. It usually entailed use for unapproved clinical indications or in unapproved subpopulations (e.g., paroxetine [Paxil] for depression in children) from a presumed drug class effect, extension to milder forms of an approved indication, extension to related conditions or extension to conditions whose symptoms overlap with those of an approved indication.  The pharmaceutical industry wanted to enlarge its markets to ensure future profits and sustain drug development. The public wanted drugs that are safe, evidence-based, and affordable; but also want the newest therapies and physicians wanted the autonomy to prescribe drugs for individuals regardless of the state of approval. 

Ask your doctor about.....

Many patients consulted their doctors after hearing of drugs on TV or in the papers.  Europe difered from the USA in its approach to Direct to Consumer Advertising (DTCA) of prescription drugs  for governments inevitably wished to control drug budgets.   In 1997 the US Food and Drug Administration (FDA) further relaxed the controls.  DTCA was a powerful tool, designed to create demand and maximise profits by encouraging patient demand. Bob Dole, a former US vice-presidential nominee, appeared in the US on a TV commercial for erectile dysfunction - paid for by Pfizer. Some drugs had become household names, Viagra, Prozac for depression, Claritin for allergies, Rogaine for baldness and Matrix for migraine.  DTCA was often inaccurate; from 1997 to 2001, the FDA in the USA issued 94 notices of violations, mostly because benefits of the drug were hyped and risks minimised.   In 1999 drug companies began ‘public awareness campaigns’ in England. These had little to do with health education, for the material and the advertisements were not about inexpensive diuretics, immunisation or cervical smears, but unsightly rashes and cures for baldness. In 2001 the European Commission proposed changes in EU law to allow DTCA for AIDS/HIV, diabetes, and asthma for a 5-year period, a proposal that was categorically rejected by MEPs the following year. New Zealand reviewed DTCA and concluded that the benefits did not outweigh the harms; similar views were held in Canada and Australia.  Internet increased pressure on doctors to prescribe the drugs publicised and industry regarded it as part of their DTCA campaign aimed at people actively searching for information. 

Increasingly drugs were cleared for over the counter (OTC) sale by a pharmacist, as was simvastatin 2004. Little time was lost in advertising it to the public once it ceased to be a prescription drug. Candidates for OTC were usually drugs for non-chronic conditions that patients could easily self-diagnose with a low potential for harm from widespread availability.  Three factors motivated OTC, the patient self-help movement, the desire to minimise costs to the public purse, and the belief by the company that this was profitable.

Screening

The National Screening Committee, established in 1996 on a UK basis, developed protocols for screening.  In 1998 it identified almost 300 screening programmes, many at a research stage and nearly 100 in practice. Only four met stringent criteria for both quality and evidence of effectiveness, breast and cervical screening, and neonatal blood spot screening for phenyl-ketonuria and hypothyroidism. There was a growing body of evidence that screening could harm people, particularly because of false-positive and false-negative results.  Breast cancer screening might save lives, but many women had breast surgery that in the event proved unnecessary.  To Wilson’s earlier criteria (see paragraph on screening in Chapter 2) was added a new one, that there should be evidence from high quality randomised controlled trials that programmes were effective in reducing mortality or morbidity.  In 2003 it was agreed to work towards a national screening programme for bowel cancer, the second most common cancer in men and women and testing of stools for blood was introduced in the over sixties in 2007.  Further trials would be undertaken for an alternative method common in the USA, flexible sigmoidoscopy.

"Multi-phasic screening" as a form of health check, had been popularized in the USA in the sixties.  Now a new form of "screening" emerged there and was subsequently introduced into the UK, whole body spiral CAT and MRI scanning.  Mobile units might offer cardiac, thoracic or abdominal scans.  Other organisations provided Doppler ultrasound investigations to the worried well.  There were, of course, some positive findings - for example young men with an operable but clinically silent cancer. Such procedures might take only a few minutes and cost £200 each, not an impracticable sum, though the marketing literature seldom spelt out what could be expected in terms of false positives and false negatives, the images often being reported by unnamed clinicians in other countries.

Radiology and diagnostic imaging

Imaging technology was increasingly central to accurate diagnosis but was costly.  The promise of digital radiographic systems was fulfilled as hospitals were reequipped with systems allowing images to be rotated, enlarged and manipulated. The filmless hospital was commonplace by the end of the decade. The Department of Health’s Picture Archiving and Communications System (PACS) increasingly enabled images to be stored and mailed electronically rather than printed on film and filed manually.

Computed tomography was developing rapidly.  In the late eighties the rotation of the x ray source was combined with continuous movements of the table on which the patient was placed. Because the tube was rotating while the subject moved smoothly through the scanner, the x ray beam described a spiral pathway. This meant more rapid scans, closer spaced scans, and a scan within a single breath-hold, giving three-dimensional images.  For example, the colon could be viewed in exquisite detail. Multi-slice scanners were introduced with not one row of detectors, but up to eight.  Image acquisition was faster and a larger area could be covered. 

Magnetic Resonance Imaging was developed to be a rapid imaging tool for the whole body.  Useful it a wide range of conditions, including neurological and cardiac disease, its ability to reveal skeletal spread of cancers, sometimes when no primary tumour had been found, made it particularly useful because radiation was avoided.  Positron Emission Tomography (PET) had a similar and increasing range of uses.In 2000, Nutt and Townsend working first in Geneva and later in Pittsburgh, combined computerized tomography scanners (CAT) with positron emission tomography.  The result was a single machine that could simultaneously image anatomical structure, for example cancerous tumours, and metabolic processes, reducing patient discomfort.  Conformational radiotherapy, which enabled accurate dosage to be given to precisely the required field even if it was irregular in shape, enabled higher doses to be given with less tissue damage and, hopefully, better outcomes. "Intensity modulated radiotherapy" enabled different doses to be administered to different parts of a tumour.  Electron beam imaging was also under development.

Progressive development of imaging systems aided the development of minimal access surgery. Image-guided surgery used imaging systems during a surgical procedure to assist its performance. Magnetic resonance imaging was the best technique, but it had not been practical because the machines had been fully enclosed. The first truly open scanner was installed in Boston in 1994, but in 1999 one was installed at St. Mary's Paddington. Surgeons had full access to any part of the patient's body, while it was scanned. Endoscopic views could be combined with MRI images, and important structures could be identified and safeguarded during surgery.

Infectious Disease and Surveillance

Terrorism

Following 9/11 and an episode in the USA in 2001 when anthrax was sent through the mail  (with many cases of skin infection and several deaths from pulmonary anthrax), the possibility of similar attacks in the UK led the government to issue guidance. The NHS and the emergency services were primed to plan and organise for bioterrorist emergences.  The US government placed a major contract for ciprofloxacin, an appropriate antibiotic.  Concern that smallpox might be used by terrorists led the US and the UK government to order supplies of vaccine and to issue contingency plans for on the containment of local outbreaks, and mass vaccination.

European health ministers planned to strengthen and extend the EU's communicable diseases network so that it could be used in the event of bioterrorist attacks as well as the threat posed to health by world-wide mobility of people, infections, food and products.  Avian influenza, in 2004/5, led to world-wide warnings of disaster and the stockpiling of anti-virals and vaccines.

Getting Ahead of the Curve

The Chief Medical Officer of the Department of Health proposed  a strategy in January 2002 to improve the system of preventing, investigating and controlling the threat of infectious diseases threats, Getting Ahead of the Curve.  A new Health Protection Agency (HPA) would combine the existing functions of the Public Health Laboratory Service and three other national bodies (the National Radiological Protection Board, the Centre for Applied Microbiology and Research, and the National Focus for Chemical Incidents) to integrate the protection of the public against infectious diseases as well as chemical and radiological hazards.  There would be a national expert panel to assess the threat from new and emerging infectious diseases. Local PHLS laboratories would be taken over by the NHS, the HPA having local health protection services, working with the NHS and local authorities, to prevent, investigate and control infectious diseases as well as chemical and radiological hazards. The PHLS opposed the idea but in August 2002 Sir William Stewart, formerly of the Microbiological Research Authority, was chosen to chair the Health Protection Agency when it was formed in April 2003.  42 Local Health Protection Teams were formed with access to expert advice on chemical and radiological issues, health emergency planning, and communications.

Infectious diseases

Annual notifications of tuberculosis in England were steady at roughly 6,000 although the number in London was rising steadily. Around seven out of every ten people with TB came from an ethnic minority group, and two-thirds of people with TB were born abroad. Six percent were multi-drug resistant.  Tuberculosis was an increasing global  problem because of the breakdown in health services in parts of the developing world, the spread of HIV infection and the emergence of multi-drug resistant tuberculosis (resistance to two key first line drugs, rifampicin and isoniazid.)  Extensively drug resistant tuberculosis (XDR) where there was resistance to at least three of the six classes of second-line agents was almost untreatable and the first British case (in a Somali) was admitted to a Scottish hospital in 2008.  In 2001 an outbreak in a Leicester school, though contained, demonstrated the need to maintain an effective tuberculosis services and to be aware of the global problems presented by the disease. Bovine tuberculosis remained a hazard and there were pressures to cull the badger population.

Britain's biggest outbreak of Legionnaire's disease occurred in July and August 2002 in Barrow-in-Furness, when a cloud of infected steam from an inadequately maintained air-conditioning unit passed over the town centre.  There were 7 deaths and a total of 179 cases.

In February 2003 an unusual form of pneumonia was recognised, severe acute respiratory syndrome (SARS).  It was responsible for the first pandemic of the 21st century.  Initially of unknown origin, it was soon found to be due to a new coronavirus.  Within months after its emergence in Guangdong Province in mainland China, it had affected more than 8000 patients and caused 774 deaths in 26 countries on five continents. It illustrated the potential of air travel and globalization for the dissemination of a new infectious disease and the need for a coordinated global response to contain such disease threats. 

Food born infection continued to cause concern. A survey of 70 general practices produced an estimate of 9 million cases annually, most of which were never seen by a GP. Campylobacter was the most common bacterial isolate, but in the majority of cases, none of the main food poisoning organisms was identified. Milk born coliform infection in Cumbria received national attention.  In 2002  Norwalk-like virus gastroenteritis affected a number of large cruise ships.

Until 2002 the UK had the luxury of being free from rabies.  That year the first case of indigenously acquired rabies occurred in over 100 years.  A naturalist and bat handler died from European bat rabies, since when infection has been verified in bats in various parts of England.  People bitten or scratched by a bat now had a small risk of developing. rabies.

Staphylococcus resistance had been a problem in the 1950s-1960s.  In the eighties infection by methicillin resistant Staphylococcus aureus (MRSA) began to increase once more. The Standing Medical Advisory Committee (SMAC) reported on the threat in 1998 - The Path of Least Resistance.  SMAC believed that up to 75% of antibiotic use was of questionable value yet society demanded easy answers and there was increasing use of broad-spectrum antibiotics.  By 2000 roughly a third of strains isolated in hospitals were resistant.  Some now showed resistance to the only remaining antibiotic, vancomycin.  The number of patients from whom MRSA had been isolated had multiplied more than ten fold over ten years. The National Audit Office reported in 1999/2000 that dirty hands and unsanitary conditions in hospitals caused 5,000 deaths a year and over 100,000 inpatients became seriously ill with infections, costing the NHS £1 billion a year.  A follow-up report in 2004 showed only patchy progress.  Voluntary surveillance of hospital-acquired infection had long been undertaken; government made it mandatory in April 2001 and launched initiatives to attempt to improve hospital hygiene and lower infection rates. By 2006 Clostridium difficile was rivalling MRSA as a cause of hospital acquired infection and death in hospital, and the Healthcare Commission publicised large outbreaks at the  Maidstone Tunbridge Wells Trust, whose chief executive resigned. 

Until the 1980s a steady stream of new antibacterials had become available. The 1980s saw little new investment in them, but that began to change. The continuing emergence of resistance strains established the need, and three approaches were followed, the modification of existing agents, genomic approaches and vaccine development. Agents such as the fluoroquinolones, active against anaerobes and streptococci, began to appear.  In January 2001 Zyvox, (Linezolid), a synthetic antibiotic of the oxazolidinone class used for the treatment of serious infections caused by multi-resistant organisms including MRSA, was approved for hospital use.  With a multiplicity of antibiotics, and ever increasing microbial resistance, accurate information on antibiotics and their proper use became essential.  A free peer-reviewed database was provided on the Internet by Johns Hopkins, Baltimore.

AIDS and sexually transmitted diseases

Internationally AIDS deaths reached record levels. In 2007 it was estimated that 33 million people were living with AIDS/HIV and that 25 million had died.  In the west, the introduction of highly active antiretroviral therapy transformed the prognosis, dramatically reducing infections and mortality.  However in the USA while infections contracted homosexually had been stable from 1992-1996, and the death rate was falling, the rate of new infections doubled over the next four years.  As a result of drug therapy more people were healthy and on the street, and people were less scared of unprotected sex. A tendency to complacency in the western world contrasted with the tragedies elsewhere. Of roughly 40 million cases, two thirds were in Africa, one fifth in Asia and China increasingly figured. In Thailand AIDS first affected homosexuals, then in turn drug users, prostitutes, their clients, the wives and girlfriends of the clients, and then the children of those women.

In 1999, it became policy in England to offer HIV testing to all pregnant women. It was in the inner cities, with their multi-racial populations, that the incidence of maternal infection was at its highest. In 2000 heterosexual sex became the leading cause of new infections in England. Since the epidemic began in the early 1980s, by 2007 about 18,000 deaths were known to have occurred. in the UK. In a tragedy that attracted little attention over 1,000 haemophiliacs contracted HIV from therapy, of whom 600 died. In 2007 there were an estimated 77,400 persons of all ages living with HIV in the UK, perhaps a third of whom were unaware of their infection. An estimated 7,734 were newly diagnosed with HIV in 2007; a third at a point after the point at which treatment had become desirable.

Two fifths of newly diagnosed persons probably acquired their infection in the UK, of whom approximately two thirds were men who had sex with men. Sixty percent of new cases were in London and a fifth of these were in Lambeth, Southwark and Lewisham, more than half of these in ethnic minority populations.  The patients might be on student visas, seeking asylum, or less commonly seeking treatment not available in their own countries.  Increasingly HIV was drug resistant, 27% of new cases in 2000, compared with 14% in 1994. (Adler M, BMJ 2003, 327: 62-3) There were only two approaches to the epidemic, preventing new HIV infections and anti-retroviral treatment for those needing it. The consensus was that in established HIV infection treatment should include a combination of three potent anti-viral drugs and there might prove to be a case for four.  In 2007 three new agents were developed for the management of drug resistant virus, two new classes of anti-HIV drugs - entry inhibitors and integrase inhibitors - and a second generation of non-nucleoside reverse transcriptase inhibitors (NNRTIs).  There was new hope for patients in "deep salvage" who were resistant to currently available drugs.  For the third world, new low cost drug regimes, administering zidovudine in pregnancy, offered a chance of reducing the infection of the fetus by the mother by some 80%; more intensive treatment from 28 weeks of pregnancy was even more successful.  But though drug companies might offer special deals, funds were hard to find in the third world and "dismal" was a charitable way of describing the treatment-coverage rates in many countries. The problem was compounded by the unwillingness of some fundamentalist churches to talk about condom use.  

Other sexually transmitted diseases

Cases of gonorrhoea in England and Wales rose from 16,470 in 1999 to 18,710 in 2007.  (In the middle of this period there was a peak of 25,000). Over 40% of the cases were in London.  Until 1998, the number of cases of infectious syphilis remained stable among both sexes in England, but then rose rapidly to 2,437 in 2008. Outbreaks were often localised, and might have different characteristics, for example  predominantly among men sleeping with men, or commercial sex work and crack cocaine use. (See Excel worksheet for detailed figures)

Cases of chlamydia had been rising since 1993, partly as a result of improving awareness and diagnosis. Cases rose from 56991 in 1999 to 121986 in 2007. The highest incidence per 100,000 was in black ethnic groups.  Chlamydia became the most common sexually transmitted infection seen in clinics  While it could later lead to pelvic inflammatory disease it frequently has no symptoms and passed undiagnosed, and these figures may represent as little as a tenth of the real number of infections.  Following pilot trials in which approximately 1 in 10 women using sexual health services were found to be infected, a national chlamydia screening programme for women aged 16-24  began in 2003, coordinated by the Health Protection Agency and a programme of immunisation against human papilloma virus began.

BSE

The Labour government established a judicial review of the handling of BSE, chaired by Lord Phillips, which reported in October 2000.  Twenty eight Ministers, civil servants and scientists were criticized in the Report.  A culture of inter-departmental dispute between the Ministry of Agriculture and the Department of Health, and unnecessary secrecy, was exposed. The public assurances of safety, given at the most senior level, had been revealed as flawed at the time they were given.  The then Chief Veterinary Officer Keith Meldrum and the Chief Medical Officer, Sir Donald Acheson, were accused of glossing over potential health risks.   ‘Safe’ seemed to mean different things to the public and to government officials.  A government compensation scheme was introduced. 

There were continuing cases of new variant Creutzfeldt-Jakob disease (vCJD), 10 in 1996, 10 in 1997, 18 in 1998, 15 in 1999, 28 in 2000 and by November 2007 a total of 166 confirmed and probable cases throughout the UK with 162 deaths had been reported. The numbers were beginning to decline.  Though infection in cattle was most marked in the UK, it was also reported in France and Germany, and human vCJD was found in France.

Molecular strain typing and transmission studies confirmed that  vCJD and cattle BSE were caused by the same prion strain. A cluster of five cases in a single small village, Queniborough, provided useful information.  All patients had lived in the village between 1980 and 1991, and died between 1998 and 2000, providing some indication of the incubation period in their cases.

To begin with nobody knew if vCJD was transmitted by blood products but in 1998 it was decided not to use UK blood plasma, and instead to import this from the US.  Whole blood was also treated to remove white blood cells.  Of those known to have vCJD at least nine had been blood donors so there was a small risk of infection from transfused blood.  In December 2003 a case of vCJD was reported in a patient who had previously received blood from a donor incubating the disease and two more followed.. In April 2004 people who had received blood transfusions were stopped from being blood donors. Blood donated by a small number of people who went on to develop vCJD was traced.  Some had received direct one to one transfusion of whole blood and they were contacted and told about the risk that the might face.  Plasma from the same donors used to manufacture products such as clotting agents was traced and recipients contacted.  Some 6,000 people were involved.

The development of better methods of identification of infection in its earlier stages opened the possibility of population screening to determine the incidence of infection. A study of 12,500 specimens of tonsils and appendix showed 3 cases of the prion responsible for vCJD, suggesting that perhaps three thousand people carried the infection. New guidelines in January 2001suggested that disposable surgical instruments should be used in operations such as appendicectomy and tonsillectomy in spite of the cost.  Shortly after operative difficulties, and possibly deaths, followed their use and they were withdrawn.  (The issue of disposable instruments also arose in relation to sporadic Creutzfeld-Jacob disease, which regretably killed notable surgeons including Donald Matson in Boston).

Hepatitis C

Compensation became available to people who had been infected with Hepatitis C from blood transfusions and developed liver cirrhosis, after the hazard was recognised but before the introduction of routine screening in April 1991 -  lump sum payments of £20,000.   John Reid extended this to cover a wider range of people infected as a result of being given blood products by the NHS.  In October 2001 compensation was also offered to victims of vCJD and their families.

Immunisation

Immunisation was one of the success stories of the NHS and high levels of immunisation were maintained.  Aside from the professional committees advising the Department, Dr David Salisbury oversaw the programme for 20 years or more and was key to its success. In 2000-01 about 94.5% of children had been immunised against diphtheria, tetanus and polio by their second birthday, and about 94% of 2 year olds had been immunised against Haemophilus influenzae b, 94% against pertussis and 87% against measles, mumps and rubella (MMR). Over the previous ten years meningitis as a result of meningococcal infection had steadily increased. More cases were associated with septicaemia and more children and teenagers were dying. A newly emergent strain, meningococcal group C, was responsible for much of the increase and, in 1998/9, a new vaccine for this strain was introduced into the routine childhood programme and in 2002 for everybody under the age of 25.  In 2001 there were 79 confirmed cases of meningitis C and three deaths compared with 551 cases and 47 deaths in 1999 before the vaccine was introduced.  Routine infant immunisation against Haemophilus influenzae, introduced in 1992, also continued to prove successful.  In 2001 an annual meningitis vaccination campaign to immunise travellers on the annual Hajj Muslim pilgrimage to Mecca, estimated at 50,000,  dramatically cut the number of cases from 45 cases in 2000 to just 6 with no deaths following the campaign in 2002. A specific vaccine incorporating the W135 strain prevalent in Saudi Arabia was used.

Rates for Measles, Mumps and Rubella immunisation fell following a paper by Andrew Wakefield and colleagues in The Lancet in 1998.  This suggested a linkage between the combined vaccine and some cases of autism.  The media took up the scare story and neither several studies suggesting that the vaccine was safe nor government campaigns alleviated anxieties.  There was a fall in uptake to below 80%.  Outbreaks of measles followed, with 740 cases in 2006 and  971 in 2007 and the first deaths since 1992 . In 2004 an author's conflict of interest emerged, undermining further the initial report.  Late in the day, the media changed sides and supported immunisation.

Other anxieties were raised about the mercury content of some vaccines.  In 2002 a vaccine against chickenpox became available, but where it would fit in to the normal programme of vaccination was not decided.  

In August 2004 the routine programme for children was modified, and a single vaccine against five diseases was introduced., diphtheria (D),   tetanus (T), pertussis (a new acellular whooping cough vaccine),  polio (inactivated polio vaccine in place of the live oral vaccine), Hib – (haemophilus influenzae type b)

The 2008 schedule for children was as below  (source DH website) 

When to immunise Diseases protected against Vaccine given Two months old Diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae type b (Hib) Pneumococcal infection DTaP/IPV/Hib + Pneumococcal conjugate vaccine, (PCV) Three months old Diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib) Meningitis C DTaP/IPV/Hib + MenC Four months old Diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib) Meningitis C Pneumococcal infection DTaP/IPV/Hib + MenC + PCV Around 12 months Haemophilus influenza type b (Hib) Meningitis C Hib/MenC Around 13 months old Measles, mumps and rubella Pneumococcal infection MMR + PCV Three years and four months or soon after Diphtheria, tetanus, pertussis and polio Measles, mumps and rubella DTaP/IPV or dTaP/IPV +MMR Thirteen to eighteen years old Diphtheria, tetanus, polio Td/IPV

Alternative medicine

Complementary, or alternative, medicine remained in public demand.  The common factor seemed to be the time and patience of practitioners, commodities in short supply in the NHS.  The Prince of Wales, like many of the Royal family, was a longstanding advocate for these therapies, or at least for research into their effectiveness.  In November 2000 the House of Lords Select Committee on Science and Technology, chaired by Lord Walton, reported that there was scant evidence that alternative remedies worked.  Yet the public spent £1.6 billion annually and 50,000 practitioners were treating some 5 million patients.  Only for osteopathy, chiropractic and  acupuncture was there limited evidence of efficacy.  The report commended some aspects of herbal medicine as a large number of effective drugs are of herbal origin, but there was no convincing evidence to support homeopathy which stuck out as being on more than a placebo. Complementary measures such as the use of massage and aromatherapy gave some comfort to patients with terminal illnesses, even though this had no effect upon the progress of the disease. The subcommittee was particularly concerned about dangerous and inaccurate information that appeared in some media articles and on internet.  Better regulation of practitioners, and control of misleading product labelling, were needed.  In December 2001 the Department of Health expressed a willingness to consider the provision of some forms of complementary medicine within the NHS, subject to evidence of its effectiveness. Almost certainly such evidence would be a long time coming.  How, in any case, could one regulate and examine people in an ever changing and expanding number of alleged disciplines, most of which had the scientific background of snake-oil salesmen?  In 2004 the Department of Health provided £900,000 to The Prince of Wales’s Foundation for Integrated Health to support its work in developing "robust systems of regulation for the main complementary healthcare professions" .  The foundation published a guide online to help people understand the main alternative therapies available.  The guide avoided the obvious question, "does it work?" In 2006 the Prince of Wales addressed the WHO, urging delegates to embrace alternative therapies in the fight against serious disease.  Leading doctors spoke out against his campaign, and a group wrote to the chief executives of all acute and primary care trusts, urging them to stop paying for unproven or disproved alternative medicine at the expense of more conventional treatments.(HSJ25 May 2006)

Medical genetics

Genetics offered the possibility of early identification of people likely to become ill, from for example vascular disease and diabetes, because some disorders of adult life are preceded by a prolonged presymptomatic period,  This opened the possibility of predicting and preventing disease, instead of diagnosing and treating it at a later stage. Genetics also provided an insight into the cause of many diseases at a molecular level, making the transition from merely describing a disease to understanding its mechanism.  Diseases previously thought of as one could be separated into categories with a different origin - and therefore treatment. For example a computer algorithm designed to seek out those breast tumours that had the most similar genetic profiles, and cluster them together, revealed that 98 cancers fell into two main groups that could be recognised on the basis of the activity of 70 genes. A woman who possessed a “poor” 70-gene signature would be 15 times more likely to suffer a recurrence within five years than a woman who had a “good” genetic signature and the second group might possibly be spared aggressive chemotherapy with all its side effects.  The possibility also existed of developing drugs with an appropriate therapeutic action. Genetics provided the pharmaceutical industry with a wealth of new targets against which to design drugs; suddenly the industry went from famine to feast and trials of gene therapy in a number of single gene diseases were underway.

Academic centres had evolved into regional centres serving populations of 2 - 6 million.  Clinical and laboratory services worked closely together, and developed "hub and spoke" systems with clinics in district hospitals.  They provided access to the latest developments, clinical diagnosis, laboratory (DNA and chromosomal) diagnosis, genetic counselling and the care of extended families long term.  In 2001 Alan Milburn invested £30 million in genetic services and in June 2003 the White Paper Our inheritance, our future - realising the potential of genetics in the NHS was published.  It painted a vision of a future health service offering personalised care based upon a person's genetic profile.  It promised increased spending on research, on the development of clinical services in primary care and the hospitals, and more education and training programmes. Research proposals were sought and funded to examine how information about a patient's genes might be used to tailor treatment to individual need, perhaps reducing the incidence of adverse drug reactions, or targeting patients most likely to respond well.

Awareness that demand for services might exceed resources also led to the establishment by the Department of Health of the Genetics Commissioning Advisory Group, to develop ways to evaluate and set priorities for genetic technologies within the NHS.  Two 'National Reference Laboratories' to help the NHS keep abreast of new genetic testing methods and discoveries, were formed in Manchester and Salisbury in 2002.

The Human Genetics Commission (HGC) was created in 1999 to provide the Government with advice on genetics and the wider social and ethical issues involved in the use of genetic data in insurance.  The Commission's concerns that the results of genetic tests might be used by insurance companies to the detriment of the population were examined by the Department of Health's Genetics and Insurance Committee (GAIC).  In October 2000 the committee agreed that to allow insurers in the UK to use genetic test results for assessing the risk of Huntington's disease.  The Gene Therapy Advisory Committee (GTAC) was also established to advise on the ethical acceptability of proposals for gene therapy research on humans and on developments in gene therapy research.

The lengthy hunt for the structure of the human genome accelerated as commercial interests united  with the international programme led by the American National Institutes of Health. A draft structure for the entire genome was announced in June 2000 and the virtually complete mapping of the human genome was completed in April 2003. Knowledge of the human genome seemed likely to underpin a further advance in clinical care. 

The development of pre-implantation genetic diagnosis (PGD) could ensure that a newly conceived embryo was not a carrier of some genetically determined diseases.  In 2004, the Human Fertilisation and Embryology Authority (HFEA) agreed to the use of PGD for assessing the risk of familial adenomatous polyposis.  By 2006, in the USA, with a credit card and a few clicks of their computer mouse, consumers could organise a test for the BRCA1 or BRCA2 gene mutation or any of hundreds of other diagnostic assays, with or without involving their physician. Direct-to-consumer marketing of genetic testing and other laboratory services had arrived.

Surgery

Anaesthesia

The advances in surgery are partly dependent on the steady advance of anaesthesia over the years.  Better drugs and better equipment have improved the speed of recovery and made the surgeon's task easier. BMJ 1999;319:557-560  Since 1948 the simple Boyle's machine carrying cylinders of nitrous oxide, oxygen and often cyclopropane, with its lever controlled vaporisers for ether, had been replaced by more complex equipment with calibrated vaporisers coupled to central gas supplies.  Chloroform and ether were superseded by halothane, enflurane and sevoflurane.  Intravenous barbiturates such as thiopentone have given way to short action drugs such as propofol (1986) with a significantly lower incidence of nausea and vomiting, and post operative drowsiness.  Endotracheal intubation was largely been replaced by the laryngeal mask airway. Neuromuscular blockade with curare or suxamethonium made possible light levels of anaesthesia and rapid recovery.  Local and regional anaesthetic techniques improved with the introduction of more reliable drugs.  Monitoring of inspired and expired gasses is easily available and blood oxygen levels were routinely monitored.

Fast track and minimal access surgery

Newer approaches to pain relief, better - sometimes regional - anaesthesia, minimally invasive techniques, optimal pain control and aggressive postoperative rehabilitation, were reducing the patients' responses to stress, shortening the recovery time.  As a result earlier discharge was possible, and fast track surgical units extended the longstanding achievements of day surgery.  Operations such as splenectomy, vaginal hysterectomy and mastectomy were becoming possible on a day or 24 hour stay basis.  Purpose-designed fast-track surgical units were appearing and these were seen as one way to reduce lengthy waiting lists for treatment. Minimally invasive surgery was facilitated by improvements in miniature video cameras producing good images so the operator and the assistant could work together.  Virtual reality simulators became available for training. Laparoscopic cholecystectomy was becoming the technique of choice.   

New surgical procedures, unlike new drugs that were subjected to clinical trial before licensing, might be developed anywhere in the world and introduced by a surgeon locally without much in the way of formality.  Indeed, many operations - for example those on the heart - would never have been developed if the high mortality among the earlier cases had been considered as it would have been for a drug.  Operative procedures were now considered by the National Institute for Clinical Excellence (NICE).  Twenty years previously  minimal access surgery had been hailed as a major advance, saving the patient pain and reducing the length of admission.  Subsequent reassessment revealed the complication rate of such operations and the techniques of open operations were improving, as in the case of inguinal hernia.   NICE reviewed minimal access surgery for hernia which accounted for 100,000 cases each year.  NICE recommended in January 2001 that people with first time inguinal hernias should have ordinary (open) surgery rather than a minimal access procedure.  For the repair of hernias that reoccurred or were on both sides minimal access surgery should be considered, a totally extraperitoneal procedure, which did not involve opening the peritoneum, was preferable.  The open procedure was, in general, cheaper.  Centrally formulated guidelines were increasingly affecting the decisions of surgeons. 

Virtual reality/robotic surgery

Developed in the eighties and nineties, virtual reality and robotics were coming to fruition. The United States Department of Defence had developed telepresence surgery to meet battlefield demands and an increasing number of systems became available, Aesop and Zeus. The da Vinci® Surgical System evolved from these efforts.  A main ambition was to apply it to heart surgery; but in the event the primary use became radical excision of the prostate, sparing the nerves on which urination and potency depended.  This proved a profitable use and the number of centres providing robotic surgery in the USA mushroomed.  In 1999 Intuitive Surgical introduced the da Vinci system, the first commercial equipment, increasingly applied to many conditions. The surgeon sits at a computer console, views a three-dimensional virtual operative field, and performs the operation by controlling robotic arms that hold the stereoscopic video telescope and surgical instruments that simulate hand motions with seven degrees of freedom. Instruments permitted smaller incisions and tremor free operating. The three-dimensional imaging and hand like motions of the system facilitated advanced minimally invasive thoracic, cardiac, and abdominal procedures.  "Master-slave" robotic procedures were also used for minimally invasive coronary artery bypass grafting and laparoscopic surgery. Neurosurgeons also were using image guided surgery and augmented reality

The next generation of instruments was likely to use the surgeon's eye movements to link instruments to the area being handled, improving visualisation, flexibility of instruments and their sensation.

Orthopaedics and trauma

Military medicine and trauma

War is an efficient schoolmaster, said a US surgeon general.  The conflicts in Iraq and Afghanistan led to major advances in trauma care.  Injured soldiers obtained a level of care of which the normal NHS patient could only dream. A military wing at the NHS hospital Selly Oak, Birmingham, took injuries but consultant care was now available in the frontline. - "we are projecting the emergency department forward into the helicopter."  An engineered process from early transfusion at the beginning of the chain, to the weekly clinical audit sessions in Birmingham led to better survival, including many with the gravest injuries who at any other time in history would have died.

From the physiological standpoint, improved understanding of the way in which the body responded to major trauma and severe multiple injuries led to the introduction of new methods of managing them. Sometimes it appeared best to intervene less in the immediate phase after injury.  Rapid restoration of fluid volume and blood pressure might lead to further catastrophic bleeding; hypothermia could sometimes protect from brain and tissue damage.  New drugs were introduced to reduce the likelihood of multiple organ failure in the weeks after injury. Increasing numbers of gunshot injuries in London and other big cities, often related to illegal drugs, sent trauma surgeons in search of the training available in countries with longer experience in this field.

Emergency care

Emergency care had to become more sophisticated. The early doubts about helicopter ambulance services had now been stilled and most areas had a scheme, often funded on a voluntary basis.  The annual number of patients steady increased.  Professor Sir George Alberti, National Director for Emergency  Access (2002), and previously President of the Royal College of Physicians, oversaw a review of Accident and Emergency Services. Sir George had been on the Modernisation Board, and was involved in service reviews in outer southeast London, and Stoke on Trent. A target was established and achieved for the percentage of patients seen within 4 hours and systems were reviewed to try to reduce the time taken by each stage of a patient's visit.  For example "see and treat" was encouraged, a senior doctor or emergency nurse practitioner being the first to review each arrival.  Changes in general practice out of hour arrangements and the increasing role of NHS Direct made it important to review accident and emergency departments and they became first in line for reconfiguration as the pattern of hospital organisation was seen to require changes.

Urgent care, as opposed to emergency care, involved patients who needed an operation within a day or two, though not necessarily immediately.  The higher mortality among people operated on at night and weekends by junior staff led to a new approach, consultant assessment day or night, and a decision about whether surgery was better delayed until normal working hours.

Trauma and orthopaedics

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Trauma and orthopaedics looked set for advance as a result of new materials, computer aided manufacturing technology and molecular biology.  The improvement of imaging had a substantial impact on orthopaedic practice.  Musculo-skeletal imaging, for example of the knee joint, made greater accuracy possible in the assessment of suspected cartilage and ligament injuries, often substantially altering treatment.

Roughly 50,000 hip arthroplasties were performed annually, mainly for osteoarthritis.  Younger patients, leading an active life, were likely to wear out the replacement hip, and NICE suggested that they should be considered for a metal-on-metal resurfacing arthroplasty, in which the femoral head and the joint were both fitted with new metal wearing surfaces.  In the USA minimally invasive hip arthroplasty was introduced, using a 3" incision and specially lit instruments, reducing pain, the time spent in hospital, and the speed of recovery.

Femoral fractures in children had traditionally been treated with traction and hospital stays of 4-12 weeks. A new technique, flexible nailing of the femur, developed in Switzerland, allowed early mobilisation. Flexible nails produced from new metal alloys were small enough to fit the intramedullary canal in children but were also able to maintain their shape after contouring and were strong enough to provide stable fixation. They were inserted through a 5 mm skin incision. The length of time spent in hospital was reduced allowing earlier weight bearing, movement, and return to school, in addition to fewer complications.  The nails were removed after the fracture had healed.

Sports injuries were an ever-growing part of the work orthopaedics.  While in the seventies and early eighties knee replacement was widely considered a poor operation, by the nineties the basic principals of successful surgery had evolved. The joint would be re-surfaced, reproducing the normal anatomy with a low friction joint, the remaining ligaments providing stability. Some 35.000 operations were now performed per year, with about a 90% success at ten years.  

Many injuries, including sporting injuries, damaged articular cartilage which had poor potential for repair.  Damage might lead to arthritis many years after injury. Transplantation of hyaline cartilage had been used for a number of years, but there are few sites where donor articular cartilage could be harvested without damaging the joint. So only small defects can be treated with this method. However, a new patented technique, autologous chondrocyte transplantation, allowed small amounts of hyaline cartilage to be harvested, the chondrocytes extracted and the cell population increased in tissue culture. The number of cells increases by about 15 times over four weeks. These cells could then be reimplanted beneath a periosteal patch which is sutured over the articular defect. 

Cosmetic Surgery

Cosmetic surgery was a growth industry and in some circles an obsession.  Both in the UK and the US the demand was growing rapidly.  In 2001, over 13,400 patients were registered as having had a breast implant. The most common reason was cosmetic augmentation (77% of total). The NHS was providing, if anything, less of a service in this field and therefore less training for young surgeons. The private sector mushroomed.  Professionally, who should be regarded as qualified and competent to carry out plastic surgery, for some were clearly lacking appropriate skills?   In 2005 the Healthcare Commission, with the support of the Department of Health, took action to regulate and monitor those providing such services. The use of botulinum toxin (botox) to reduce wrinkles was popular. In the US it was approved by the Food and Drugs Administration for the removal of wrinkles and Botox parties were commonplace.  In the UK Boots planned to provide facilities in some of its larger stores.  Collagen fillers were widely used and sugar molecule injections looked set to become the next hot cosmetic item.   With increasing obesity in the population, bariatric surgery for the morbidly obese was increasingly common and became part of the regular work of many acute hospitals. 

Cardiology and Cardiac Surgery

Diagnosis was increasingly aided by developments in imaging and non-invasive techniques.  Magnetic resonance imaging could assess heart function, mass and volume, and detect heart infarction. Ultrasound could assess heart function. Contrast media, in association with MRI, could demonstrate infarcts. Ultra fast CT scanning for coronary artery calcium might indicate an increased risk of a heart attack. There was a clearer understanding of the pathology of coronary arterial plaques.  Better blood tests such as the measurement of plasma myeloperoxidase made it easier to predict  risk of myocardial infarction.

Cardiovascular disease had a significant place in plans for improving health.  A National Service Framework for Coronary Heart Disease was introduced in 2000 and outlined good practice, smoking cessation clinics, rapid access to chest pain clinics, rapid thrombolytic treatment, shorter delays for assessment and treatment, more effective use of aspirin, beta blockers and statins after a heart attack and more coronary artery surgery. Guidelines for preventing disease, for example by blood pressure reduction, were refined.  Death from ruptured aortic aneurysm, some 6000 per year, was shown to be reducible by ultrasound population screening. Estimation of cardiovascular risk became the starting point of therapy, using risk tables covering age, sex, blood pressure, smoking and cholesterol status, and conditions such as diabetes. It was recognised that unstable and acute coronary disease could be due to a vulnerable plaque, which might not tightly narrow a coronary artery but could be affected by various risk factors. Acute coronary syndrome, which could proceed to a heart attack, might be treated by early administration of a glycoprotein inhibitor. There was often dramatic improvement from the use of anti-platelet and thrombolytic agents in the treatment of coronary disease Action could be taken to reduce the risk of clot formation associated with common cardiovascular disorders such as atrial fibrillation and heart failure, various cancers and after orthopaedic surgery. . Wald & Law suggested that heart disease and stroke could be reduced substantially by giving, on a population wide basis, e.g. to those over 55 years, a "polypill" that would reduce low density lipoprotein, cholesterol, platelet function and blood pressure.  Possible constituents might be aspirin, a statin, a ß blocker, a thiazide,  an ACE inhibitor, an angiotensin II receptor antagonist and folic acid.  

The prognosis of congestive heart failure was improved by the use of ACE inhibitors. Guidelines suggested that high blood pressure, a major contributor to heart disease and stroke, was best treated with a combination of drugs. A new class of drug, vasopeptidase inhibitors, were shown to be at least if not more effective in the treatment of high blood pressure, cardiovascular and ischaemic heart disease, than the existing ACE inhibitors.  The evidence of benefit to patients with high blood cholesterol levels and atherosclerotic disease from the use of cholesterol lowering drugs, e.g.statins, had been clear since the mid 1990s.  Yet although they were easy to take, effective and comparatively free from side effects, they remained under-used.  Less than a third of patients who had a history of coronary artery disease or stroke received lipid lowering treatment.  In 2003 some statins were made available over the counter.  

Manual defibrillators had long been available but required training, e.g. interpretation of electrocardiograms, restricting prompt treatment. In adults the commonest primary arrhythmia at the onset of cardiac arrest is ventricular fibrillation or pulseless ventricular tachycardia.  Survival is crucially dependent on minimising the delay before providing a counter shock.  Ambulances seldom respond rapidly enough to provide defibrillation within the desirable eight minutes. This led to ways of automating defibrillation so they could be used by those untrained. (Liddle R et al. BMJ  2003;327:1216-1218)  Automated external defibrillators (AEDs) that talked the attendant through the process began to make their appearance in public places.  They proved highly effective in public settings where there were designated rescuers (e.g. flight attendants or security guards) or a large number of bystanders were immediately available. Used within first two minutes after collapse they improved outcome over traditional methods. In 2002 AEDs went on public sale in the USA, with FDA approval, for about $2500.  In 2004 they became available without prescription and in the UK a range

Coronary artery surgery

Early in the decade in some areas of the USA ambulances were routed past hospitals towards cardiac centres equipped to perform surgery and  angioplasty 24 hours a day.  By 2006 this became routine in many British centres as well.  The two main procedures for opening up blocked coronary arteries, balloon angioplasty and open heart surgery were rivals. Coronary artery bypass grafting (CABG) was more invasive, requiring lengthy rehabilitation.  However new techniques allowed bypass grafting on the heart while beating, reducing the morbidity associated with the pump and induced cardiac arrest.

Percutaneous coronary angioplasty (PTCA) usually required one or two days in hospital, and patients could expect to be back at work within a week. Primary angioplasty could be used in the early stages of a heart attack and seemed to improve patient outcome.  First undertaken in 1977, the procedure was now regularly undertaken throughout the country.   Restenosis initially occurred in over 30% of patients but with advances in stent design and improved techniques for implanting them the rates came down to 10% - 20%. This is comparable to the 10% of vein grafts that are lost in the year after bypass grafting.  Newer stents were made of metal coated with a cytostatic agent such as sirolimus or paclitaxel.  These agents were released slowly and locally to reduce proliferation of smooth muscle and might reduce arterial restenosis.  ^{Grech ED, BMJ2003; 326:1080-2.}  As the decade ended the long term advantages of the two procedures remained a matter of debate but the demand for cardiac surgery was shrinking.  However the NHS was increasingly organised to provide angioplasty as an emergency procedure round the clock.  In 2006 in London 6 centres were nominated across the capital to which ambulances went directly, the paramedics having identified the patient as having had a heart attack.

Artificial heart systems had been developed in the early 1980s and had been used in the US and Europe, though only occasionally in the UK. As well as total heart replacements with a high stroke volume, left ventricular assist devices (LVADs) with small electrically powered pumps, provided a lesser stroke volume and pulsating blood flow that could be used to support the patient's own heart and give it time to recover.  The larger total replacements were used as a bridge before heart transplantation,

Some drugs used to treat disturbances of heart rhythm could themselves have dangerous effects.  Implantable cardiac defibrillators were used to treat ventricular arrhythmia; automatic cardioverter defibrillators could be life-saving and promising new developments took place in pacing technology. Particularly in younger patients this improved substantially as did the introduction of  catheter ablation, the accurate destruction of an area of the heart responsible for the disturbance of rhythm, through a catheter within the heart. Multiple leads could be inserted to synchronize contractions of the different chambers of the heart and improve heart output.

Deep vein thrombosis, for long recognised as a hazard of bed rest, came to public attention following the death of a young passenger flying from Australia.   Studies showed that perhaps one in a hundred passengers flying long haul developed thrombosis, asymptomatic. Lancet 2003; 362: 2039-44   It seemed associated with lengthy flights, alcohol consumption and failure to move about the cabin. 

Organ transplantation

The results from organ transplantation steadily improved with advances in immunosuppressive therapy. From the early 1980s onwards drugs such as cyclosporin and tacrolimus had made modern transplantation care possible.  Mycophenolate mofetil (MMF) reduced the risk of acute rejection and monoclonal antibodies were also increasingly used.  In 1969 less than half those transplanted survived a year.  Now 95% had a functional kidney after a year and most would probably work for 20 years.

Some 3,000 new cases needed a transplant annually, and some 3,000 were transplanted.  However there were 8,000 on the waiting list and roughly three people died daily waiting for transplantation.  The Alder Hey report on retained organs (2001) appeared to reduce the number of those prepared to consent to organ donation (even for example corneal replacement).  Some centres began to retrieve organs from non-heart beating donors as well as conventional brain dead donors. In the USA patients were increasingly urged to look for a live donor among their friends and

 relatives where a kidney or part of the liver might be given. Transplant survival was better and the wait for transplantation shorter.  For other organs the dearth of donors was even greater. As a result of the increased use of seat belts and the better treatment of subarachnoid haemorrhage and strokes the number of organs available for transplantation fell throughout the decade. Donors had to be "fit but dead" and most potential donors were to be found in critical care units - perhaps only 2,500 people a year were suitable.  In 1999 the BMA voted in favour of an ‘opt-out’ system so that the organs of those dying were automatically available unless there was a written statement to the contrary. Transplant surgeons, however, preferred the existing 'opt-in’ approach, fearing public reaction to a more radical policy. Under pressure from public pressure groups, in 2006 Ministers established the UK-wide Organ Donation Taskforce, chaired by Elisabeth Buggins, to identify barriers to organ donation and make recommendations.  Reporting in 2008, Organs for Transplants, the Taskforce looked at the pathway from potential donor death to transplantation, and the obstructions in the way. Its recommendations aimed to make an unusual procedure usual, and to encourage location action to solve a national problem.  It sought a National Donation Organisation within NHS Blood & Transplant.(NHSBT) which was established as a Special Health Authority in October 2005..  It suggested appointing 100 additional transplant coordinators to increase donation, removing financial disincentives from hospitals whose own patients would not in fact benefit, Trust Donation Committees to encourage local action, and pursuing the possibility of an opt-out system (which was favoured by the Prime Minister, Gordon Brown).  However the arguments against this, consent could never truly be "presumed", its legality under human rights legislation, the difficulty of ensuring everyone knew that an opt-out right existed, and the absence of evidence that countries with an opt-out system did better, led to this approach being discouraged.  Live donor transplants provided some organs, but the risks to the donor were not insignificant, particularly in the case of the liver.

Heart transplantation survival rates improved over the decade especially in the first year after the transplant. About 88 percent of patients survive the first year after transplant surgery, and 72 percent survive for 5 years. The 10-year survival rate is close to 50 percent, and 16 percent of heart transplant patients survive 20 years.  Yet since 1995 there had been a significant fall in the number of patients receiving new hearts, lungs, or heart and lungs through transplantation. In 2000 265 patients in the UK were treated and there were six heart and lung transplant centres in England (Birmingham, Cambridge, London, Manchester, Newcastle and Sheffield).  The need to ensure that centres undertook enough operations to maintain expertise was appreciated, and a National Specialist Commissioning Advisory Group took on responsibilities for commissioning heart and lung transplants for both adult and children.

The techniques necessary for the re-attachment of limbs had already been developed and in 1998 the first  hand transplant was carried out in France, a second – more successful – was undertaken the following year in the USA.  The first face transplant was also undertaken in France in 2005.

Stem cell transplantation was revolutionizing the outcome of a range of malignant and non malignant blood disorders, including immunological diseases.   Stem cells could be obtained from blood, bone marrow and umbilical cord blood.  Cord blood banks were established in London, Bristol, Belfast and Newcastle to collect, preserve and type blood products, and to test for viral contamination.  

Neurology & neurosurgery

Neurological disorders account for 10-20% of hospital admissions, stroke being one of the commonest causes.  The outlook of patients with stroke was improved by very early thrombolytic therapy if intracranial bleeding could be ruled out by an early (within 3 hours) MRI scan. The outcome in the UK was poorer than most European countries, where rapid assessment and transfer to specialised centres was more common.  In the UK treatment might  be by general physicians or geriatricians, rather than by neurologists with easy access to precise imaging systems, vascular surgery and specialised stroke units.  Most district general hospitals did not have a 24 hour on call neurological and scanning service, usually relying on visiting neurologists from elsewhere.  A National Stroke Strategy, stressing the need for immediate admission of those with strokes or indeed transient ischaemic attacks (TIA) to a unit that could provide brain imaging on arrival, 24 hours a day, was published in 2007. People had to recognise early signs of a stroke which needed to be treated as a medical emergency. The development of stroke care networks and redesign of services across networks to ensure appropriate urgent care for stroke and transient ischaemic attacks became a priority - some SHAs for example Oxford, Newcastle and London responded rapidly.

Many new drugs were being introduced for epilepsy, not all of which appeared to be better tolerated or more effective. For temporal lobe epilepsy, surgery emerged as the most effective treatment.  Costly drugs, which only had a slight effect on diseases otherwise difficult to treat, were a particular problem for neurologists, for example the interferons in  multiple sclerosis and drugs in dementia.

Some rare neurological diseases had long been known to have a genetic cause; now gene mutations were discovered that increased the risk of developing a common one, Alzheimer’s disease. As in other fields of medicine, there was hope that the identification of causal factors at a molecular level would open the way to treatment that would influence the course of the disease. As brain cells did not appear to regenerate, it would be important to develop an early diagnostic system, so that treatment, when available, could begin as soon as possible. The newer systems of imaging, for example positron emission tomography (PET), sometimes gave indications of how a neurological disease was developing, and how brain function was affected. National strategy, however, was mainly aimed at earlier diagnosis.

Advances in neurosurgery were driven by technology. Frameless stereotaxy linked information from CAT or MRI scans, through computer linkages to sensors that could ‘know’ where the skull was. Magnetic resonance imaging could be used to display blood vessels including the carotid arteries.  Stereotaxic systems helped the surgeon to navigate safely through high-risk areas of the skull and brain, knowing exactly where the surgical instruments were. Interventional magnetic resonance imaging provided another possibility, with enough space within the scanner for the patient to move and for some neurosurgical procedures to be carried out.

Ophthalmology

Progress in ophthalmology was steady. Artificial lens implants had revolutionised cataract surgery. Foldable intraoccular lenses could be inserted through a small self-sealing incision. Better drugs became available for local treatment of glaucoma and endoscopic laser techniques also helped in its treatment.
A new treatment became available for age-related macular degeneration, a common cause of blindness. This involved monoclonal antibodies, anti-VEGF therapies (vascular endothelial growth factor), a sub-family of growth factors.  These included bevacizumab (Avastin), antibody derivatives such as ranibizumab (Lucentis), or orally-available small molecules that inhibit the tyrosine kinases stimulated by VEGF : sunitinib (Sutent), sorafenib (Nexavar), axitinib, and pazopanib.  From 2006 NICE reviewed the evidence for their efficacy and agreed that they should be used under some circumstances.

Cancer

World-wide, the occurrence of cancer steadily increased - populations were often older and other causes of mortality were being attacked. Many cancers were related to diet, but precisely to what dietary habits in different countries was unclear. Infections, for example Hepatitis B and Helicobacter, were also responsible. Genetic factors were being discovered.  Some families had a very high incidence of particular cancers and specific gene faults could be identified. Survival from cancer in the UK was lower than in many European countries and the USA. The United Kingdom used chemotherapy less, access to diagnostic services and staffing levels were poorer, there were fewer oncologists and 40% of cancer patients never saw one. A major problem was undetected spread at the time of first treatment and the difficulty of reducing the delay from referral or diagnosis to first treatment, particularly in radiotherapy. Government, through a National Cancer Plan (NSF) (2000) aimed to improve coverage, staffing levels and service organisation.

Cancer networks were established and effort went into re-engineering the clinical pathways. Government pledged that patients with suspected cancer would be seen within two weeks of referral by a GP.  However reports from the National Confidential Enquiry into Perioperative Deaths (November 2001), the Commission for Health Improvement and the Audit Commission found that standards of care were variable and too few patients, particularly when admitted as an emergency, saw a cancer specialist. The report by Calman & Hine was in many places far from implementation. In 2007 a new plan, the NHS Cancer Reform Strategy, was launched.  Key elements included focus on prevention, spending more on radiotherapy equipment, faster treatment, extended screening, fast-track drug approval and extended services for the increasing numbers of people surviving cancer.

Slow improvement was taking place, particularly for cancer of the breast, colorectal cancer, non-Hodgkin's lymphoma and leukaemias.  For men in early middle age the prevalence of smoking had halved between 1950 and 1990 and the death rate for lung cancer at ages 35-54 fell even more rapidly.  However women and older men who were smokers in 1990 had higher rates than in 1950.  In 2000, the deaths of women from cancer of the lung exceeded those from cancer of the breast for the first time.  The survival of women diagnosed with breast cancer was improving and the age band for breast screening was increased.  Deaths in England and Wales fell 21 percent between 1990-1998 because of screening, earlier diagnosis, better treatment, including the addition of chemotherapy and hormonal treatment, e.g. Tamoxifen.  It was hard to separate the effects of screening and adjuvant chemotherapy as both had been introduced at the same time. The diagnosis of cancer of the breast was an area in which errors were regularly made.

Surgical treatment for cancer improved  and was increasingly conservative, retaining organs and structures where possible.  Radiotherapy centres were increasingly well equipped and tomographic treatment machines gave a more accurate dosage.  Linear Accelerators and "multi-leaf" collimators allowed radiation doses to be delivered to the precise shape of the tumour and helped to reduce the volume of treatment irradiated, sparing normal tissue around the cancer. Precision therapy greatly increased staffing requirement and there was a shortage of radiographers. A new advance in radiotherapy, CHART - Continuous Hyperfractionated  Accelerated Radiotherapy (CHART) was introduced.  Radiotherapy was given for 12 successive days, including weekends, 3 times each day, with a 6-hour gap between treatments. The total dose was higher, and there might be side effects, but in lung cancer treatment the "cure" rate seemed better.  Further ahead was the possibility of charged particle beam therapy consisting of protons or carbon ions produced in a synchrotron or cyclotron, the first facility being at Clatterbridge (Wirral).  Bone marrow transplantation remained central for some cancers, and the cure rate of acute leukemia in children improved.

Pharmaceutical research moved from the search for new cytotoxics to drugs acting on defined molecular mechanisms. There was an explosion of information about the molecular biology of cancer, but the dramatic successes achieved in some rarer cancers were not repeated in the commoner ones, breast, lung or colon. Controlled trials improved the results of chemotherapy as new agents were introduced, as for example in colorectal cancer and cancer of the breast (anastrozole and letrozole). In hormone-dependent breast cancer, five years of postoperative tamoxifen therapy  prolonged disease-free and overall survival. The aromatase inhibitor exemestane, by suppressing estrogen production, was found to improve the outcome after two or three years  tamoxifen therapy. 

Some of the newer drugs were used mainly to extend the survival of people with terminal cancer.  Cure remained uncommon but survival might be lengthened. Karol Sikora, from Imperial College, predicted that within 20 years cancer would be considered a chronic disease to be controlled, such as diabetes and asthma.  The new treatments would be more selective, les toxic and given for long periods, perhaps life long.  The NHS would have difficulty in paying for everything available. When their effectiveness became apparent they might be used earlier, as in the case of paclitaxel (Taxol) in ovarian cancer, one of the earlier drugs to be assessed by NICE and recommended as standard initial therapy. Oxaliplatin (trade name Eloxatin) & irinotecan (trade name Campto) were approved for metatstatic colorectal cancer. Three drugs for small cell lung cancer were also approved, gemcitabine, paclitarel and vinorelbine. 

Monoclonal antibodies, after many years, began to live up to some of the expectations.  There was rituximab (Mabthera) for low-grade non-Hodgkin lymphoma. The antibody attached to the B-cell surface receptor, present in most cases.  Another was trastuzumab (Herceptin), that targeted a protein on the surface of fast-growing cancer cells, and was accepted for advanced breast cancer in 2002.  Given much earlier to people with aggressive breast cancer carrying the HER-2 gene it achieved a major reduction in recurrence rate. There were many more monoclonals in the pipeline, each active against a receptor on a malignant cell surface. It was a growth area with high costs.  Another group of drugs active against cancer were anti-angiogeneis drugs, which keep tumours from developing good blood supplies. 

The development of a vaccine against infections with human papilloma virus (HPV), which though often benign could lead to cervical and anogenital cancer, opened the possibility of preventing a substantial number of cases.  In 2006 the vaccine received its European licence and a programme of vaccination, starting with young girls aged 13 started in September 08 with a massive nationwide campaign.

Obstetrics & Gynaecology

The 6th Report of the Confidential Enquiry into Maternal Deaths (CEMD)  in the UK was published in 2004.  Maternal death is a rare event, 391 being reported from 2000-2002. The main causes of death remained the same as ever, thrombo-embolism, haemorrhage and anaesthesia.  However sepsis was staging a come-back, and the largest cause of death overall was psychiatric, generally depression.  In addition it was clear that women in families affected by unemployment, who lived in deprived areas, or from minority ethnic groups were at substantially higher risk of death than others. The titles of the reports changed to reflect the rarity of maternal death and the linkage of the health of the mother and the child. CEMD and the Confidential Enquiry into Stillbirths and Infant Deaths (CESID) merged to form the Confidential Enquiry into Maternal and Child Health (CEMACH) on the 1st April 2003. From 2006 it became a four yearly report, providing an overview of the numbers and causes of maternal death in the United Kingdom. 

The 7th Report of the Confidential Enquiry into Maternal and Child Health in 2007, (deaths between 2002-2005) showed that over 20 years there had been little improvement in the figures. Something over half of the deaths directly or indirectly associated with childbirth occurred in women who were overweight or very obese, mothers who were older and often from disadvantaged communities including immigrants and asylum seekers. Some of the avoidable deaths were the result of doctors failing to manage medical conditions effectively that were outside their normal expertise, for example heart disease. Black African women, including asylum seekers and newly arrived refugees had a mortality rate nearly six times higher than white women. To a lesser extent, black Caribbean and middle eastern women also had a significantly higher mortality rate.

The nature of antenatal care - and making it more sensitive to the parents' desires - was the subject of several reports, starting with Changing Childbirth in 1993 with a vision of midwifery-led, woman-centred care in which women could choose where to give birth. There were plenty of pilots but no systematic change.  In 2007 came Maternity Matters, which set out the wider choice framework for maternity services, including a guarantee (within safety limits) of choice over where to give birth, how to give birth and what pain relief to use.  There was little fundamental change.  A supplementary document to the Lord Darzi's London report (2007) also looked at obstetric services nationally, and the place of home delivery, midwife led units (either stand-alone or co-located with a hospital unit) and hospital obstetric units.

The pattern of antenatal consultations and care had remained much the same for half a century since the time when its importance was first appreciated.  In 2003 (further revised in 2008) NICE recommended evidence based changes and suggested that care should begin earlier, around eight weeks to give women more time to make decisions about screening and to plan the kind of antenatal care that they would like.  Ultrasonography should be carried out at 10-13 weeks, to increase the accuracy of pregnancy staging.  Healthy women pregnant for the first time should typically be offered 10 appointments, and 7 in subsequent pregnancies.  All women should be offered screening for fetal Down's disease during their pregnancy. During delivery continual monitoring of the fetus became near universal.  Defensive obstetrics was important for hospitals needed evidence of good care in case of  future legal actions. To safeguard the health of the baby, networks of neonatal units were established so that women in labour could be transferred when desirable to a unit providing the most intensive neonatal care.

There was an ever increasing demand for fertility treatment, often in women who had delayed pregnancy until their mid-thirties. Births from successful IVF steadily increased. In 2007 36,000 women received treatment and there were more than 11,500 births from IVF or intra-cytoplasmic sperm injection (some multiple births).  NHS resources being limited, most of this was undertaken in the private sector at personal cost.  More than one embryo was often implanted to increase the success rate and the number of multiple births in older women increased rapidly.  Many babies were of low weight, and delivered early, increasing NHS costs.  The pressure on the NHS to make fertility treatment part of mainstream NHS services was successful - NICE recommended that three cycles of treatment should be available to women age 23-29 years of age. (HFEA figures)

The abortion rate has been rising since records began - apart from the odd dip from time to time. It stood at 14.8 per 1,000 women in 1988, but 18.2 per 1,000.in 2007. The rate for under 16s was 4.2 and for under 18s it was 18.9.  The highest abortion rate was seen among 19-year-olds with 36 per 1,000 women.  By 2007 almost 200,000 terminations were being performed annually.  From January 2001 the "morning after" pill became available over the pharmacist's counter rather than solely through medical channels. A third of abortions was carried out on women who had alread had one. In 2008 parliament reviewed the 24 week limit for termination, and left it unchanged.

Clinical genetics was increasingly applied to diagnosis and treatment.  Pre-implantation genetic diagnosis developed apace. For example the ability to screen, in vitro, for the inherited Fanconi syndrome enabled a clinical tour de force - the selection of one among a number of embryos for implantation that was not only unaffected by the disease, but which led to the delivery of a baby whose cells could be used to treat an elder and sick sibling. The Human Fertilisation and Embryology Authority (HFEA) decided to allow selection of an embryo so that a baby could become a donor for a brother seriously ill - the so-called saviour sibling.  Similarly women in  families predisposed to cancer of the breast could be assessed so that only embryos free from the significant gene were implanted.   International travel made it possible for those with the money to evade national legal controls on embryo sex selection.

Gynaecology

Improvements in imaging, endoscopy and drug treatment all contributed to steady advance in gynaecology. Fibreoptic endoscopes enabled the replacement of some major operations by minimally invasive procedures. Ectopic pregnancy could be diagnosed early by ultrasonics and treated by laparoscopic surgery. New approaches to the treatment of heavy menstrual loss were developed, for example endoscopic ablation of the endometrium by laser. Simpler methods of treating endometrial polyps were also possible. Better understanding of the risk and frequency of incontinence after delivery, and the technique of the repair of tears, offered more hope to women suffering such embarrassment. The development of a vaccine against the most common forms of human papilloma virus offered the prospect of a radical reduction in the number of cases of cervical cancer.

Concern about injuries to the pelvic floor was among the reasons for rising Caesarian section rates.    While a Caesar carried its own risks, neither doctors nor patients resisted the pressures to do everything possible to ensure a good outcome for the baby.  To try to produce good evidence about the incidence and advantages of section, the Royal College of Obstetricians and Gynaecologists undertook a large-scale survey; the section rate was 22% and many obstetricians believed this to be too high.

Problems with reading cervical cytology slides emerged from time to time.  Even in units recognised to be of high quality  the inherent difficulty in reading test results led to audits that showed repeated failures to identify abnormal smears. 

Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone replacement therapy (HRT) in healthy postmenopausal women remained uncertain. A US trial of a combined oestrogen/progesterone preparation was stopped in May 2002 after an average 5.2-year follow-up among healthy postmenopausal US women, because risks (for example invasive breast cancer, heart disease and stroke) exceeded benefits, e.g. a reduction in fractures. (JAMA. 2002;288:321-333).  Over 2 million women were reported to be taking HRT in Britain and an MRC trial of long duration oestrogen after menopause had been underway since 1996. It was decided in November 2002 to bring this trial to an end as well.  The results of the "Million Women Study" (Lancet 2003; 362: 419-27) confirmed the increased incidence and death from breast cancer, particularly for oestrogen-progestagen combinations, leading to calls for its prescription to cease. HRT might be responsible for an additional 5,000 cases of breast cancer in that country annually. BMJ  2003;327:767.   In 2006 it was reported from the USA that the number of cases of breast cancer was falling since many women had stopped taking HRT following the publication of the evidence of a linkage  It became increasingly clear that for many years the pharmaceutical industry had quietly encouraged the use of their products by providing financial support to meetings that were essentially PR, and organisations encouraging the use of HRT, some of which had apparently been established by groups of oestrogen product manufacturers. 

Paediatrics

The quality of services for children had been a concern over the years (Platt 1958, Court 1976). A Children's Task Force was established in 2000, and Professor Al Aynsley-Green was appointed national director for children's services to lead the development of a national service framework to improve the 'fragmented and poorly coordinated' services that children might receive (2004). His framework reiterated principles of care expounded since Platt.  Children were different, needed to be looked after by people who understand their particular needs, and should have services designed specifically for them. Accessible and age appropriate services were needed, earlier diagnosis and intervention, and a smoother transition from child to adult services. There must be someone at senior managerial level in every NHS organisation who took responsibility for ensuring that children's voices were heard. Existing policies could improve without any major investment of money. All newborn babies should have access to the most appropriate care where and when they needed it and there should be regional networks of care to minimise the need for transfer.  However in 2007 the Healthcare Commission reported that a substantial number of hospital trusts still could not provide round the clock life support care for children, and called for re-configuration of paediatric services to make this practicable.

The increasing ability to diagnose fetal defects by antenatal ultrasonic scans, and the emergence of feto-maternal medicine as a specialty, meant more work for paediatric surgeons. Spina bifida, kidney and bladder diseases might be diagnosed before birth. Surgery immediately after birth could be planned, and where the defect might result in the death of the fetus or neonate, fetal surgery was sometimes possible, sometimes endoscopically.

Organ transplantation in children presented difficulties not found to the same extent in adults. Drugs used to suppress immune reactions might affect growth. Nevertheless advances in medical knowledge and surgical technique extended the range of indications and improved both survival and the quality of life. The outlook of children dying of liver, kidney or heart failure was revolutionised. It became possible to transplant kidneys at younger ages with a good chance of success. Liver transplantation was extended to the neonatal age group. Congenital heart disease and cardiomyopathy could be treated by heart transplantation. Paediatric transplantation was a victim of its own success. Improved survival led to increased referrals and waiting lists.

Geriatrics

Although the elderly were now usually admitted to acute wards, the care they received was still sometimes of questionable quality. Articles in the Observer in September-October 1997 raised issues about poor basic nursing care and lack of equipment, and the Health Advisory Service (HAS) established a project to examine the care of elderly people in acute wards in 16 general hospitals throughout England. The fabric and design of the wards was often poor, equipment might be lacking, ward routine might be inflexible and patients might not be helped to eat or drink. Long delays for emergency admission, poor quality food and problems with privacy and dignity were also identified. The HAS preferred specialised facilities for the elderly rather than those integrated with other facilities.  This was strange as most acute admissions now were of the elderly. It asked for national standards, that older people should be helped to eat and drink, should lie in a clean, dry bed, and be treated with respect. In March 2000 the new Commission for Health Improvement had, as one of its first tasks, to act to improve care in Cumbria, where the North Lakelands Trust had been shown to fall far short of acceptable standards.  In March 2001 the Standing Nursing and Midwifery Advisory Committee's Report "Caring for Older People : A Nursing Priority" was published.  The report said

"There is a great deal of evidence to support the conclusion that the care that older people receive often fails to meet their most basic needs for food, fluid, rest, activity and elimination and the psychological and mental health needs of older people are often entirely neglected in acute health care settings. The nursing care of older patients is mainly deficient in terms of fundamental skills, such as communication and helping a patient to maintain their nutritional status, skin integrity and continence."

In March 2001 the Government published a new National Service Framework for Older People as a ten-year programme setting new national standards and service models of care across health and social services, covering "age discrimination", person centred care, intermediate care, general hospital care, specialised stroke services, falls, mental health and the promotion of an active healthy life. Professor Ian Philip became National Director of Older People's Services.  The NSF aimed to: root out age discrimination in the NHS, provide person centred care, provide intermediate care to prevent unnecessary hospital admissions and to ensure timely discharge from hospital, ensure older people receive the specialist help they need in hospital, reduce the incidence of stroke, reduce the number of falls, promote good mental health and promote health and active life in older age. 

To geriatricians the most worrying feature was its proposals for developments in intermediate care. Geriatricians with long memories recalled that in the 1960s there were many intermediate care beds outside acute hospitals, into which "bed blocking" old people were transferred in the hope that somehow they would disappear from the system. Geriatricians spent their lives getting such beds closed and their staff resources transferred to acute hospitals to provide the specialist rehabilitative care needed to get people safely and expeditiously home. Specialist geriatric rehabilitation units are crucial elements of comprehensive acute hospital services but are expensive. It might prove convenient for managers to confuse convalescence (spontaneous recovery) with the more expensive rehabilitation that is necessary to make non-spontaneous recovery happen. Those geriatricians who defended specialist rehabilitation units might now have to fight to prevent their beds being downgraded to intermediate care. Indeed, managers might seek to close rehabilitation units to free money for purchasing intermediate care beds in private sector nursing homes. There was also a risk that older patients could be sent directly to intermediate care, bypassing the skilled diagnostic evaluation that the complexities of disease and disability in old age require.  

Labour, before their victory in 1997, had accused the Conservative Government of forcing thousands of pensioners to sell their homes to pay for long term care. The Royal Commission on Long-Term Care for the Elderly (1999) proposed making all nursing and personal care, including help with washing and dressing, free to all who were assessed as needing it. Labour was now cool towards this solution, with its immense costs, and concluded that personal care would not be free in England.  The devolved Scottish parliament decided that it would be, opening up a division in health care provision within the UK.  Nursing care, on the other hand, defined as anything that a registered nurse provided or supervised, would be free.  A compromise had to be made between idealistic aspirations - totally free medical and social care for the elderly - and what could be afforded within budget.  Legislation in the Health and Social Care Act (2001) made it possible to charge for "intermediate care" after the first six weeks. The problem was at least as great for the social services that were often responsible for the costs after discharge. As social service departments paid for residential and nursing home care for people discharged from hospital, their financial problems affected the NHS.  Private residential and nursing homes began to close because payments did not cover the cost of providing a staff intensive service, and the cost of meeting (quite properly) newly introduced standards of accommodation.  More and more hospital trusts reported that it was difficult to admit emergencies as it was difficult to discharge older patients requiring care;10-50 beds might be blocked in this way in an acute hospital.   Government suggested in 2002 that local authorities might be made to bear the cost of patients in hospital who were waiting for a local authority social services placement.

Alzheimer's disease was among the conditions in which genetic problems were sought though specific genetic defects represented less than 10% of the total of cases. In the great majority of cases there was no evidence of a specific gene being involved, though genes seemed related to the production of amyloid protein within the brain.  Aberrant processing of amyloid precursor protein, leading to increased production and aggregation of amyloid peptide in the brain, seemed central to the pathogenesis of Alzheimer's disease.  This in turn suggested types of treatment that might in future be developed.  Three drugs, cholinesterase inhibitors,  for treating mild or moderate Alzheimer's disease were approved for use in the NHS by NICE in January 2001. 

Mental illness

A National Director of Mental Health, Professor Louis Appleby, (the 'mental health czar') was appointed in 2000. He said that key areas of the National Service Framework would include: 

• phasing out mixed-sex psychiatric accommodation

• the elimination of out of area acute admissions as soon as possible

  Organisational change had a substantial impact on psychiatry and community care.  Changing organisations and changing boundaries of, for example, the Mental Health Trusts, made the development of team work with social work services difficult.  As patients were discharged into the community, some old mental hospitals such as Friern Barnet (North London), St Francis (Haywards Heath), Oakwood (Maidstone) and The Royal Holloway (Virginia Water) were converted into high quality living accommodation for the well-to-do. Developers appreciated the amazing assets these former institutions possessed. Yet care in the community as a policy only produced new problems. SANE, a voluntary mental health charity primarily concerned with schizophrenia, believed that while it worked for some people, it let down many others. A social experiment meant true liberation for many people who, with the new drugs, were well able to live outside hospital, but for others it had meant fighting for mental and physical survival alone in flats and bed sits, or with their families who broke down under the strain. There was a famine of community psychiatric nurses, and there needed to be enough hospital places, places of asylum in the true sense of the word.

• 24 hour access to mental health services for patients and carers

• new training for psychiatrists in 'cultural awareness'

• a drive to encourage more nurse consultants in the mental health area, particularly to work with people with mental ill-health and drug and alcohol problems.

A new vision was emerging in the mental health services. Two big ideas were that patients with mental illness should be treated in the community, and that young people with early psychosis should receive timely and comprehensive intervention at the outset.  The National Service Framework for Mental Health (September 1999) followed pledges in the NHS Plan and increasingly money flowed into mental health services. Over several decades large mental health hospitals had been closing, to be replaced by community psychiatric teams, generally with too few staff yet with wide responsibilities for cases of many different types.  This 'generic' approach where teams were responsible for all the problems in their community often proved inadequate.  Increasingly teams with particular skills and smaller case loads were formed to provide specialised services, for example crisis and early intervention services (to reduce the need for admission), personality disorder and  prison in-reach. Crisis Resolution Home Treatment (CRHT) teams helped people through short-term mental health crises by providing intensive treatment and support outside hospital, ideally at home.  Made up chiefly of mental health nurses, with additional input from consultant psychiatrists, social workers, occupational therapists and psychologists, they could denude the community health teams who were left to handle large case loads of  people whose problems did not fall into specific categories. Muijen M, HSJ 2003, 9 Oct, 18-19.  The National Audit Office reported in December 2007 that the introduction of CRHT teams was associated with reduced pressure on beds, and the teams were successfully reaching service users who would otherwise probably have needed admission. CRHT teams were also supporting the earlier discharge of people from inpatient treatment – for example in around 40 per cent of the discharges in the NAO sample.

Government accepted that there had been too many failures of the policy and promised £1 billion and a review of the Mental Health Act 1983. Government strategy, Modernising Mental Health Services, had two essential elements

• increased investment to provide more beds, outreach facilities and 24 hour access and new treatments.

• increased control of patients to ensure compliance with treatment in the community, and a new form of revisable detention for those with a severe personality disorder.

In December 2000 a White Paper, Reforming the Mental Health Act aimed to deal with public concern about care in the community that had led to the release of hundreds of patients some of whom did not receive care, becoming a risk to themselves and others.  Such releases had contributed to 1000 suicides and 40 murders a year.  A draft Mental Health Bill, published in June 2002 attracted criticism over the proposals for compulsory detention and treatment of people with dangerous severe personality disorders and the withdrawal of the Bill, with the promise of new legislation published in November 2006. Finally a new Mental Health Act was passed in 2007 which allowed people with serious personality disorders to be detained, even if they had committed no crime, if a danger to themselves or others. It also allowed compulsory treatment in the community under certain circumstances.

The 1999 NSF proposed targets including a 20% reduction of suicides. A strategy to reduce suicides among high risk groups, promote mental well-being in the general population and to research suicide and suicide prevention was published in September 2002, measures to include the improvement of the prescribing of antidepressants and analgesics, and partnerships to identify and improve safety at suicide ‘hot spots’ such as railway bridges.

New and 'atypical' antipsychotics were introduced that were said to produce fewer extrapyramidal side effects and to  reduce the suicide rates, compared with conventional drugs such as chlorpromazine, e.g. amisulpride, olanzapine, quetiapine, risperidone and zotepine.  The new drugs were many times more expensive than the existing ones and there was public and professional pressure for their widespread use.  It took 20 years before careful examination of the clinical trial evidence showed major flaws, for example comparing the new drugs with haloperidol, a drug known to have many serious side effects.  Marketing and publicity had overtaken science.  However the extent to which street drugs such as crack cocaine were often taken by patients with recognised psychiatric problems was an increasing hazard. Though the evidence for their cost-effectiveness of these "second generation drugs" was equivocal, in June 2002 NICE approved their use both for patients with side-effects from the traditional drugs, and as a first treatment.   There was also hope that the new drugs in the pipe-line would modify the disease, rather than merely treat the symptoms. Perhaps, caught early, schizophrenia would go into full remission, or the progression of Alzheimer’s disease might be alleviated.

Learning disability.

Hospitals for those with learning disabilities had been the centre of a number of scandals in the 1960s/70s.  They still hit the headlines from time to time.  In 2007 the Health Care Commission found that Orchard Hill Hospital in Sutton and Merton was 'in a time warp' and delivery care at an unacceptable level, describing "some of the environments in which people lived as impoverished and completely unsatisfactory. Staff were not properly trained or supported to provide an acceptable level of care, and inadequate levels of staff meant that people were often left day in day out with little to occupy their time. There were failures in management and leadership at all levels, from managers to the trust’s board"  The Commission decided to inspect some 200 similar institutions, recalling Richard Crossman's establishment of the Hospital Advisory Service in 1970, to do precisely the same thing.

General Practice and Primary Health Care

Links in this section

The future pattern of general practice Alternative entry points to care NHS Direct 24 hour responsibility  Our health, our care, our say Contractual issues Personal Medical Services Contractual discussions Systems of organisation Practice based Commissioning

During the sixth decade of the NHS major changes were taking place in primary care.  The pattern of practice was altering and this was reflected in a new contract partly based on quality and outcomes. Primary care worked within a health service that was changing in its financial flows and its structural organisation.  The pattern of practice was driven by changes in disease, in where people could best be treated, financial considerations, an increasing load of treatable chronic disease, obesity and health promotion - plus the desire of doctors to work more normal hours.    The pattern of the NHS was moving towards greater patient choice and competition or, at the least, "contestability.".

For overseas readers who may not know much about UK primary health care Everyone registers with a general practice in which each of the doctors probably have about 1,800 patients and holds lifetime records of patients.   There are two types of contract in UK general practice: GMS and PMS.  Roughly 70% of GPs are independent practitioners and have a GMS contract and 30% have a Personal Medical Services contract and are generally salaried.  GPs traditionally owned their own premises and they work with nurses, health visitors, midwives, secretarial and computer support.  However the NHS and other organisations increasingly provide premises. GPs are responsible for health promotion, care of acute disease, and long-term care of chronic illness, referring to hospital when necessary.  GPs undertake 3 years vocational training before entry to practice. Until recently they were responsible for 24 hour care.  Responsibility for out of hours care has now passed to primary care trusts.

The pattern of practice

The classic pattern of primary care, the "RCGP model" with continuity of care, was breaking down and not solely in the UK.  Other countries identified the changes and the problems. JAMA 2008, 299: 13; 1595-6.  Increasingly advice to patients was given by A & E, ambulance services, paramedics, emergency care practitioners, walk-in centres and NHS Direct. GPs had little or no control over other professions who were expanding their roles. A service without continuity as a feature might meet the needs of people with acute and often minor problems and many people seemed content with this.  It was not necessarily the best way of coordinating multiple complex chronic illnesses, for no one was then accountable for effectively managing care. Government and the medical profession seemed to be colluding to undermine continuing co-ordinated care,   Doctors were adopting new attitudes to patients and vice versa. The old pattern of lifelong continuous service by a GP was increasingly replaced by doctors, sometimes salaried, who came and went.  GPs preferred a Monday to Friday day time service.  This they virtually achieved, with increasing emphasis on health promotion, disease prevention and chronic disease management.  (Cox J, Br J Gen Pract 2006, 56, 83-4)   The 2006/7 UK General Practice Workload Survey showed that GPs were seeing fewer patients (perhaps 90/week) than at the time of the previous survey, but were spending more time with each patient, 11.7 minutes.  More consultations in practices were with nurses and the proportion rose from 21% to 34% between 1995 and 2006.  More consultations were by phone, and visits were fewer partly because of the use of out of hours services. ^{(Trends in Consultation Rates in General Practice 1995 to 2006 www.ic.nhs.uk)} 

Practices had more staff - the average practice about 24 many of which were non-clinical. The hours they worked were much the same. There was little home visiting.  Anticipatory health care, along the lines suggested by Julian Tudor Hart, was increasing and being institutionalized.  For the first time GPs were working for organisations based in the community, with a focus on management, support and leadership - primary care trusts (PCTs). The community nurse caring for chronic disease, the out-of-hours rebellion by GPs who wished for more control over their lives, the desire of younger and part time GPs for a salaried service, modern information technology and new types of contract were destroying the traditional pattern of practice and the gatekeeper role with it.  Only half the population thought his mattered; many were happy to see any doctor as long as it was convenient.

Alternative entry points to care.

The role of the GP as set out in the classic text of the 1960s "The Future General Practitioner" was now out-dated. A White Paper, Building on the Best (2003), implied that the GP as the as the sole, centre-point of continuity of care, was on the way out; commuters might have a GP near their work as well as near their home. Quite apart from pharmacists and nurses, there were now three competitive provider models.  Government became eager to ensure that new practices were opened where they were needed, and that if possible these should not be along traditional lines, but use newer contractual patterns such as "Alternative Provider Medical Services."

Entry points into general practice NHS Direct A telephone advice service. Consultations are with nurses, who use clinical assessment software similar to that used in NHS walk-in centres. The average consultation length is 14 minutes. Walk-in centres Wide opening hours (usually 7 am to 10 pm every day); Services that meet the needs of their identified population.  Walk-in access, without the need for an appointment, convenient location, attempt not to duplicate existing services, increasingly general practitioners on site and good links with local general practices.  Provision of information and treatment for minor conditions, and health promotion, supporting people in caring for themselves.  Maximise the role of nurses; use of skill mix, Nurses supported by computerised software for clinical assessment.  The average consultation length is 14 minutes. Sources: Salisbury C et al.  BMJ 2002; 324: 399-402;  Grant C, Nicholas, R, Moore L, Salisbury C, BMJ 2002;324:1556

Pharmacists

A new pharmacists' contract in 2004 added another source for care, for it encouraged pharmacists to expand their role into chronic disease management, supervision of repeat prescriptions, smoking cessation and other appropriate services.  A White Paper (Pharmacy in England, Building on strengths - delivering the future) in 2008 heralded further development in the role of pharmacists, in part to undertake simple forms of care that might otherwise occupy family doctors.

Physicians Assistants

In 2005 the Department of Health consulted on the possibility of a "medical care practitioner" - physician's assistant - perhaps on the lines of the North American model.  Such practitioners might

• Obtain full medical histories and perform appropriate physical examination;
• Diagnose, manage (including prescribing) and treat illness within their competence;
• Request diagnostic tests and interpret the results;
• Provide patient education and preventative healthcare advice regarding medication, common problems and disease management issues; and
• Decide on appropriate referral to, and liaison with, other professionals.

There was agreement that such practitioners would be useful particularly in primary care and in 2008 the Universities of Wolverhampton, Birmingham and Warwick with Coventry launched the first course to physicians assistants.  T

There was the possible introduction from the USA of Retail Health Clinics - the 'doc in a box'.  The organising principles were taken straight from the fast food industry, convenient locations (e.g. Wal-Mart), long opening hours, limited menu and low prices. Some dozen or more companies, owning and running some 200 clinics each, provided nurse practitioners working from guidelines who for a fixed charge dealt with anything that a mid-level practitioner could do. Anything requiring judgment was referred.  The average costs were substantially lower than in a physician's office or emergency room, and patients liked the accessibility, low costs and walk-in availability.

NHS Direct

Department of Health negotiators had at times bearded the BMA's GP negotiators about the problem of accessibility of family doctors in comparison with banks such as First Direct.  In 1997 the head of operational research in the Department of Health asked "what would an NHS look like that was radically reconfigured so that demand could be handled by direct means" such the telephone, TV and Internet.  The subsequent establishment of  NHS Direct in March 1998 was one piece of a rapidly developing mosaic of first points-of-contact for health care.  High on Labour's priorities, this 24-hour telephone triage system, operated by nurses, advised callers on the most appropriate form of care. Sophisticated computer-based software helped the nurses, reducing the possibility that potentially dangerous symptoms would be overlooked.  The scheme became nation wide in November 2000. Call centres might be based with ambulance services, which had much of the necessary infrastructure.  The clinical support software was steadily improved.  

NHS Direct responded to consumerism and technology, doing what cash machines had done for banking, to offer a more accessible, convenient and interactive gateway. The telephone service was supplemented in December 1999 by NHS Direct Online.  It also provided information about clinical conditions.  The website attracted people who were seeking information about problems often on an anonymous basis while the phone lines attracted those with an immediate problem.  The numbers of callers steadily increased and the numbers kept growing. The website was expanded to incorporate a new health encyclopaedia with information on common conditions.

Surveys showed substantial user satisfaction although only 64 per cent of callers managed to speak to a nurse within five minutes & one in five callers had to wait more than 30 minutes for a nurse to call them back. It was no cheaper than GP consultations and many patients were referred. There was no evidence about whether NHS Direct made more or fewer mistakes than a GP would have done.  A National Audit Office Report stated that on the evidence NHS Direct was operating safely, and advice to callers erred on the side of caution; there were 29 adverse event cases in three years, fewer than one for every 220,000 calls.  NHS Direct undertook continuous evaluation and audited 1% of calls.

Government aimed to make NHS Direct a single access point for out of hours care, integrating and controlling practice by, for example, making direct bookings for patients at the surgery and providing a point of entry for 999 calls, out-of-hours calls to GPs, information about emergency dental and pharmaceutical services and handling low priority ambulance calls.  In 2003  plans for further expansion were announced. NHS Direct would

• provide a single access point to NHS out of hours services, working with other NHS providers to ease the burden on GPs and emergency services.

• assume responsibility for fielding 999 calls deemed to be of low importance.  Patients with non urgent conditions would be transferred to their local NHS Direct call centre, where a nurse will offer advice over the phone.

• become a separate national organisation as a special health authority,  independent of the Department of Health, with funding devolved from Whitehall direct to PCTs from 2004.

Additional functions were added, for example patient reporting of adverse drug reactions. In April 2004 NHS Direct was established as a Special Health Authority.  By the end of the decade the service was answering 25,000 calls a day at 35 call centres and employing 3,000 people.  The commonest reasons for calls were rashes, abdominal pain, dental, tooth and jaw pain, and medicines advice.

Walk-in Centres

In another initiative Government, initially against professional opposition, piloted walk-in centres in stations and shopping malls. Some were located in or near major hospitals. Thirty six were announced in 1999 and by 2004 87 were in operation or planned for example at main line railway stations such as Liverpool Street, Kings Cross and Canary Wharf.  Private sector organisations such as Care UK obtained contracts to run some of these. The centres tended to see patients of working age during the working day, often when people were away from their normal GP, at work or on holiday.  Basically nurse-led minor injuries clinics and triage points and increasingly there might also be a GP on site.  They offered simple advice and treatment for minor health problems.   Consultations were often lengthy and nurses would have computer-based decision support software. The most common reasons for attendance were minor viral illnesses, unprotected sexual intercourse (emergency contraception) and minor injuries. Four out of five people could be handled without onward referral.  They did not greatly affect the workload of local GPs, but if there was a nearby local minor injuries unit, that would receive more patients.

Primary care "one-stop" centres - a concept proposed in the 1987 White Paper Promoting Better Health, and which resembled the 1948 concept of health centres, re-emerged as a government ideal.  These might be associated with a walk-in centre and offer a broad range of services including primary care nurses, specialist GPs, pharmacists, therapists and diagnostic services.

Practice premises

NHS Estates, a central government agency, continued to support the design and development of GP premises.  As part of the NHS Plan government introduced a new way to fund premises, the local improvement finance programme (LIFT) in which primary care providers would collaborate with private investors to build facilities.  Most were owned by the private developer, but some were developed with public money and money from the GPs if they wished.  The schemes might provide space for health related and appropriate retail services, and seemed particularly suitable for urban and deprived areas where GPs were reluctant to invest their own capital.  In 2002  a total of 42 such centres were announced and the first such a centre (Manor Park), costing £4.9 million, was opened in November 2004 in Newham.  It contained three general practices, health visitors, accommodation for dentists in the future, a pharmacy, a cardiology clinic, X-ray, pathology and optometry services, and a healthy living café. Particularly in areas where there was a shortage of GPs, government began to look to the private providers. In May 2006 Care (UK) opened primary care facilities in Barking and Dagenham, family doctor services being provided to the NHS by the private sector. Government influenced the procurement process in under-doctored areas, making it easier for larger organisations to put forward proposals.

GPs with Special Interests (GPwSI)

Partly driven by the problems of GP recruitment, the BMA's Health Policy and Economic Research Unit proposed in February 2002 that the existing medical workforce might be better utilized by greater use of nurses (themselves in short supply).  A new pattern might be needed in general practice.  Nurses were becoming increasingly important in the provision of primary health care.  Government considered that "community matrons" might would remove the need for the patient to attend the GP surgery or outpatients or stay in an acute bed unnecessarily.  More efficient use of doctors time might allow them to devote more time to tasks which require their advanced levels of clinical training and specialization. Research suggested that the introduction of nurse practitioners in the surgery did not significantly change the workload of the doctor.  Full nurse-substitution would require a pattern of nurse training that included the complex problems of the diagnosis of ill-defined and newly presenting problems

Both general practitioners and government were coming to view the role of primary care differently.  The NHS Plan (2000) could be read as implying that much that the GP did could be done by nurses, and GPs might become intermediate level specialists as the BMA Unit's report suggested.  General Practitioners and Nurse Practitioners were increasingly specialising in particular aspects of clinical management, education or research. _{Nocon A & Leese B, BJGP 2004, 54, 50-56.} GPs were taking on tasks previously more commonly the responsibility of secondary care, providing such services for patients outside their own practice, and being paid specifically for them.  This development was viewed with approval by the Royal College of General Practitioners (RCGP). Led by the Modernisation Agency, there was a move to accrediting GPwSIs, particularly if they could provide a service that could avoid hospital referral.  PCTs began to contract for services.  By 2003 there were more than 1250 of GPwSIs in specialties such as dermatology, ENT and cardiology.  Often they worked in fields where there was a long waiting list to see a consultant. The additional equipment needed by GPwSIs was extensive and expensive, costing anything from £10-40,000, and the cost-effectiveness was open to question.  Rapid access to hospital facilities for complex investigation was also necessary.  Several models were developed, fully independent from secondary care, services with close hospital support, services with consultant triage, or fully based in the hospital.  A measure of specialisation appealed to some GPs.  It was clear, however, that such services were an addition to, rather than substitution for secondary care.  GPwSIs represented a new way to configure services, and one that management could influence.

24 hour responsibility

Traditionally the work of most doctors included evening visits to the home and an occasional night disturbed by an emergency call. Continuity of care had been a core value.  Since the introduction of deputising services in the 1960s, and later GP cooperatives,  GPs had increasingly devolved care to them, 90% of GPs fulfilling their out-of-hours responsibilities in this way.  With increasing demand for 24 hour access and changes in the medical workforce - over half the entrants being women - this was inevitable.  Since 1948 the GP's contract had provided for 24 hour patient care and pay had been on that basis.  In 2000 John Denham, the Health Minister, said that out-of-hours primary care would in time move from the GP to NHS Direct, and the members for the BMA English GP Committee voted to end their legal responsibility to be on call 24 hours a day, forcing a review of this principle.  For 30 years government had found the 24 hour commitment convenient and economical but a new contract in 2003 gave GPs the right to opt out.

From December 2004, GPs could transfer their out-of-hours responsibilities to an "accredited organised provider of out-of-hours services", subject to the approval of their PCT.  Ninety percent did so. PCTs were responsible for coordinating provision and accrediting providers of out-of-hours services. The cost rapidly escalated, putting pressure on the budget for primary care. In 2005 the cost in England was £392 million, 22% higher than predicted.  Some PCTs had to fly doctors in from Europe to provide a service. The private sector saw the possibility of handling the administration, triage, call handling and providing cars and drivers for duty doctors.  Among a variety of arrangements, PCTs increasingly looked at Ambulance Trusts for assistance, and alongside paramedics Emergency Care Practitioners emerged as people who might make a first assessment of a patient making an emergency call.  There was income to be raised by the provision of an ECP service. Some Ambulance Trusts organised lengthy and comprehensive training courses; others did not.  There was a rise in emergency admissions and a move of other professionals to fill the gap GPs were vacating.

Concern about a deterioration in out of hours services became a political issue.  Gordon Brown, incoming as Prime Minister, made it a priority agianst initial GP opposition to get them to provide more services for a longer part of the day, for example in the evenings.  An Interim Report from Lord Darzi set a target of half of all practices to offer out-of-hours services - with a clear instruction for PCTs to find someone who will if GPs would not.

Our Health, Our Care, Our Say

A White Paper (Our Health, Our Care, Our Say, a new direction for Community Services) was published in January 2006 by Patricia Hewitt, Secretary of State.  It had a strong emphasis on life style and health promotion and restated policies that previously existed (e.g. more pay for GPs in deprived areas), shifting expenditure from hospitals to the community and preventative services, bringing some specialties from the hospital nearer to people, e.g. dermatology, ENT, orthopaedics and gynaecology, and an expert patient programme.

In 2007 the Royal College of General Practitioners (RCGP) published a roadmap on the Future of General Practice that analysed the problems and the environment in which GPs were now operating now that they were no longer the main entry point to the NHS or working within a single model of practice organisation.  The College suggested that GPs should become 'federated' into larger groups to provide a wider range of services such as scans and x-rays to cover most health problems in the population, including mental health, closer to patients’ homes. Generalists and specialists would work more closely together to ensure that hospitals were reserved for acute illness, specialised investigations and major surgery. The College was attempting to work with the Department of Health and the document was universally supported by professional bodies.  The Department of Health published Our vision for primary and community care, along with Darzi's report in July 2008. (summary)  There was a greater emphasis on prevention and in particular a vascular risk assessment programme for those between 40-74 years, improving quality of care through focussing on outcomes in the quality and outcomes framework, and increasing choice for patients who would be given a greater role in shaping services.

The move to a pattern of larger units was accelerated by the reintroduction of the idea of polyclinics, either very large centres or by a hub and spoke pattern with central facilities used by local practices.  Lord Darzi, reporting in 2007 on health services in London, had suggested polyclinics, providing walk in services as well as those for registered patients, with specialist and investigative support.  He proposed the opening of a 100 new practices in areas with poor provision delivered by a wider range of providers, some perhaps in the private sector.  There was a highly politicised and polarised row.  The King's Fund tried to clarify issues in a report Under One Roof, concluding that there was a real issue about shutting down smaller practices and a single model, in particular a highly centralised co-located one, would not be suitable for all areas.  A poll conducted for The Times revealed contrasting views of doctors and patients.  Almost half patients thought polyclinics would improve the standard of care and access, and that seeing the same doctor on each visit or in an emergency did not greatly matter.   GPs opposed them and argued for continuity of care, an aspiration that in practice could never be fully delivered. (The Times 23 February 2008) One private provider, United Health, obtained the contract to run three practices in North London. Sainsbury's and Asda  piloted the provision of  surgery space to local doctors in stores in the evening.  The BMA's General Practice Committee and some in the RCGP feared that the strengths of British general practice were being undermined by officials lacking in understanding of primary health care; the was published in the wake of the final Darzi report in July 2008

Contractual issues

From 1948 until 1997 all GPs worked under a single contract for services, nationally negotiated and set out in "The Red Book". The NHS (Primary Care) Act 1997 was passed shortly before Labour came to power and allowed health authorities to commission primary care services from GPs and others within the NHS in new ways. A new style contract for personal medical services was often with a  group or practice, instead of with individual GPs and were for a defined package of services.   Contracts were local, rather than national, with a firm linkage to quality; and services could be tailored to the needs of specific groups, such as the unemployed.  It became possible to test alternative systems for delivering primary and community care schemes and to try our new mixes of skill. There was a realisation that the standard contract did not meet the needs of all communities equally well; and in addition that there was a case for more competition in primary health care. 

In 2003 the Health and Social Care (Community Health and Standards) Act allowed Primary Care Trusts to commission care from "anyone capable of securing the delivery of those services"  It established four contracts

• General Medical Services (the traditional GMS contract as revised between trusts and practices not individuals)

• Personal Medical Services (PMS see below)

• Primary Care Trust Medical Services (PCTMS) in which PCTs provided services themselves, directly employing staff

• Alternative Provider Medical Services (APMS) in which the PCT contracted with an individual or an organisation, e.g. independent sector organisations such as United Health Europe or Care UK, the voluntary sector, other PCTs, Trusts or even a parallel contract with GMS or PMS practices.

 The legal basis of practice had changed, and commercial law was now involved in contracts, not public law alone.  The monopoly of individual GPs as contractors was broken. _{Pollock A et al. BMJ  2007;335:475-477 (8 September)}. Alan Johnson, Secretary of State, felt that existing practices had no God given right to particular populations.  Personal Medical Services contracts became popular. Services were unbundled and, instead of a single individual providing everything (in theory), additional or enhanced services such as screening or the care of chronic conditions could be provided by different systems. Commercial firms, and some groupings of general practitioners took advantage of these opportunities. Boots entered the market by offering to provide premises for primary care teams in their stores – in 400 there was excess space that could be converted.  GPs obtained a 5-10 year lease in accommodation newly converted with their needs in mind in areas where this was difficult to find in, for example, in Birmingham city centre.

Personal Medical Services (PMS)

This new type of contract (begun under the Conservatives and expanded under Labour) was based upon  ideas discussed between the Department of Health and the NHS GPs' negotiating body in the early 1990s.  Flexible salaried contracts established by management locally might meet the needs of inner cities better, and overcome a problem of the traditional contract that made short term employment impossible.  PMS were piloted and became a mainstream option before evaluation was completed.  GPs seemed willing to trade income for better conditions, freedom from out of hours working, from administrative responsibilities and an ability to work part time. Salaried options appealed to the doctors early in their career, those approaching retirement and to women, but the hope that they would help deprived areas was not always realised.  Often it was in the affluent areas that salaried doctors were to be found.

Some PMS schemes delivered traditional primary care; others provided community services as well, and in a few "nurse-led" practices a nurse might be the first point of contact.  There was a progressive shift towards a PMS/salaried service, often with salaried GPs working alongside 'independent contractor' GPs. In a succession of waves, the numbers of GPs involved increased steadily and in 2003 it was decided to ensure that pay increases matched those of doctors on standard contracts. From March 2004 it became a permanent alternative to the general medical services contract and by 2005 40% of GPs worked under PMS contracts.  Fixed 1-3 year contracts and  a salary of perhaps £55,000 for a ten session week, made the prospect appealing.  Indeed when a new contract was later introduced, PMS payments were ratcheted up and the contract was very appealing to the doctors indeed.

Towards a new contract - contractual discussions

Both the profession and government wanted changes to the standard contract to reflect emerging patterns of practice.  GPs wanted to reduce the scope of their responsibility to a core of essential services (so that additional work would be separately priced), to remove the contractual obligation to provide 24 hour cover, and to be able to choose their pattern of work.  Government wanted teamwork, better access for patients, and an emphasis on quality of care.  GPs and their teams should be rewarded for the quality and range of their services, rather than speed in seeing patients. The NHS Plan set out to encourage the majority of GPs to move to a contract under the PMS scheme. A new "core contract" was proposed by government aiming to link pay to the quality of service.  Postgraduate education and clinical audit would become mandatory.  Many of the changes were only possible because of the increasing use of computers in the recording of practice activity.  In June 2001 a majority voted to resign their contracts if it was not possible to achieve a reduction in paperwork, directives and workload.  Alan Milburn handed over the perennially hot-potato of negotiation to the NHS Confederation.  The negotiators achieved the near impossible, paying castly more money for somewhat less work.  In April 2002 new proposals were sent for consultation. The timing was favourable, immediately after the announcement of more money for the NHS. 

• The list of patients would a practice one, not relating to individual GPs.  This opened the possibility of salaried posts and part-time working.  Payment would be based on the numbers of patients, the services offered, the quality to which they were delivered, and the needs of patients taking account of their age, sex, deprivation and morbidity

• All GPs would provide essential core services, the care and management of those who are ill or think they are ill,  and the general management of the terminally ill.  Most would boost their income substantially by offering additional services, including vaccination, cervical screening, antenatal care and the management of chronic conditions.  If they opted out an alternative provider would be sought.  There would also be enhanced additional clinical services, some of which would be needed everywhere, others might be specific to a particular area.  A proportion of a practice's payment would come from a quality element of the contract, which might include clinical quality standards (process), organisational standards (structure) and patient experience.   There would also be an annual "achievement" payment.  Practices would be given money for infrastructure expenditure such as additional premises, staff or information technology. GPs would be allowed to opt out of the obligation to provide cover outside a five day week,  Primary Care Trusts assuming the responsibility

• There would be new skill-mix initiatives (i.e. nurses performing some of the roles previously undertaken by doctors), and acceleration and expansion of the roles of other health care professionals, such as pharmacists, in primary care. 

• There would be a progressive programme of "demand management" focused on information and education to enable the public to care for themselves and use the NHS appropriately.

GPs had asked for a radical new contract, to drop 24 hour responsibility and to be rewarded for delivering high quality care.  The contract was based on targets - some 147 performance indicators. Thought also be given to the personal medical services contract.

Government announced increased resources for primary care of some 30% over three years. It used to be said that half a dozen people, three in the BMA and three in the Department, fully understood how GPs were paid; now nobody could grasp .the new contract, more complex said the BMJ, than the Minotaur's labyrinth. The new contract used a complex formula based on weighted list-sizes which produced odd effects  At a conference of local medical committees in May 2003 the GPs instructed negotiators to renegotiate key points with the Government.  Ultimately by four to one GPs accepted the contract and in September 2003 the detailed terms were agreed. Implementation took full effect from 1 April 2004.  Most practices continued to improve the quality and range of services they provided through the Quality and Outcomes Framework (QOF) to which some 20% of the primary care budget was tied  This resulted in significant increases in GP income but also considerable investment in their practices in terms of additional GPs and nurses and increases in practice productivity.  This gave Primary Care Trusts and Government a financial headache, compounded by the agreement that doctors with PMS contracts should have similar increases and that there should be a protected minimum practice income guarantee.  The contract was estimated to have cost £300 million more than had been expected for the average net salary rose from 2003/5 to 2004/5 by over 30%, to more than £100,000. The National Audit Office reported on the effect of the new contracts.  The additional money, far more than had been planned, had achieved at least in part some (but not all) of the anticipated benefits. It had not helped deprived areas much and there were doubts about productivity. In 2008 the Public Accounts Committee also delivered a damning report; pay had risen an eye-watering 58% but targets had been set too low and the contract had failed to live up to expectations.  Gordon Brown, made extended surgery opening a priority.  After acrimonious negotiation and a poll, general practices accepted the proposed changes to the contract for 2008/09, which would give GPs financial incentives to provide longer opening hours. [How GPs are paid]

Systems of organisation,  Primary Care Trusts and commissioning

The organisational framework

Changes in the NHS organisational framework are dealt with in Chapter 6A.  During the decade family doctors, for years administered and managed by bodies solely established with them in mind, came to be managed within a broader framework.  After NHS reorganisation in 1974 they were in theory within the remit of Area Health Authorities, but AHAs remained at arms-length.  However the amalgamation of Family Health Services Authorities into Health Authorities  (1996)altered the situation.  The belief that primary care determined the work of the hospital services led in turn to health authorities, primary care groups and then primary care trusts to manage the family doctors but also, as purchasers or commissioners, had a strong relationship with hospitals and community services.  For the first time since 1948 general practice/primary care, and community care, was brought into a single organisation with a unified budget.  The same organisations not only came  to manage family doctors, but to run community nursing and to set the contracts for hospital services as well.  Inevitably PCTs became planners and funders, under the aegis of strategic health authorities.  The name Primary Care Trusts was a misnomer; they were a long way from simple administrators of GPs. Structural change in the management of primary care was also dictated by changes in the patterns of financial flows. 

The rise and fall of fundholding

In the early 1990s, the Conservative government tried to contain increasing demand and rising costs in the NHS by the purchaser-provider split and the introduction of GP fund holding. Hospital contracts were placed in two ways, by fund holders for their patients and district authorities for the rest.  Though voluntary, the number of GP fund holders was spectacular; by 1998 about 55% of the English population were covered by some kind of fund holding arrangement. Fund holders were energetic, and academic evaluations suggested that they cut elective admissions and waiting times. They drove service reform and led doctors to consider management issues as few policies before, or since.

Pros and Cons of Fundholding	Source: Ray Robinson, HSJ, 3 July 2003, 18-19
Positive	Negative
Small scale organisations, combining financial and clinical decision making, were able to harness the enthusiasm of GPs eager to develop their practices	Many commissioners and contractors increased transaction costs.
Fundholders achieved shorter waiting times for their patients and reduced unnecessary hospital referrals, while health authorities proved unwieldy , slow to move and constrained by threats to local stability.	Evidence of a two tier access to health care between patients of fundholders and patients of non-fundholders.

GPs who opposed fund holding but wanted to help shape secondary care teamed up to advise health authorities through "locality commissioning", a model more to Labour's liking.  With Labour in power, fund holders were given a clear signal in December 1997 that fund holding would end in April 1999, and to maintain the influence of primary care on hospital expenditure GPs were brought together within Primary Care Groups (PCGs) to commission all secondary care except mental health services.  In England around 500 PCGs, each covering populations of around 100,000, took over from nearly 4000 health authorities, fund holders, and locality commissioning groups.  PCGs could operate at various levels of complexity and influence, and were encouraged to move forward to become Primary Care Trusts (PCTs).  From April 1999 all GPs in England and Wales worked within PCGs/PCTs that commissioned or purchased secondary care for their populations. All had limited annual prescribing budgets and ring-fenced funds (based on weighted capitation) for providing general medical serv­ices and developing primary care.

Primary Care Groups were encouraged to develop into Primary Care Trusts, (PCTs), which were  substantially larger than their predecessor fund holding or commissioning units.  These were not definable in neat geographic terms, the areas being decided by the homes of those on the list of participating GPs. GPs lost influence in the management of organisations that were becoming mini-health authorities, and whose Chief Executives had often worked for the previous health authorities. PCTs increasingly concerned themselves with the complexities of secondary care and their vision of the future was not solely that of their GPs. The wide responsibilities stretched PCT management. Recruitment of top calibre staff was difficult.  Progressively PCT mergers were considered to ease the difficulty, or sharing back-office functions such as payroll, or partial or full merger of management teams covering more than one PCT.

Primary Care Trusts began to flex their muscles.  Stronger practice management, the modernisation of premises and their concentration into larger centres perhaps providing wider diagnostic facilities and outpatient services, and a move towards nurses as the first point of contact particularly out of hours, were on the agenda.  Unlike the management bodies of the past, they increasingly influenced the way GPs worked, for example by the introduction of "care pathways". The Bradford PCT, a leader in developing new functions, worked towards "demand management" and "the best use of hospital services".  GP specialists began the triage and treatment of urological conditions (performing cystoscopies), dermatological conditions, "uncomplicated" neurological referrals, musculoskeletal problems, diabetics, and minor surgery (for example vasectomy and 'minor eye surgery'.  PCTs, responsible for implementing the new GP contract could employ GPs with special interests to achieve their goals, for example the improvement of the care for chronic conditions.  Similarly they might encourage the adoption of PMS contracts, which allowed the Trust greater management powers and facilitated the design of out of hours services.  It also made it possible to plan the devolution of commissioning to practice level, giving them financial autonomy.

Practice-based commissioning (PbC)

Fundholding was followed by practice based commissioning.  PbC had resemblances to fund holding and received a widespread welcome though there would be no personal financial advantages for doctors. The use of national tariffs reduced the possibility of hospitals offering "bargain basement" services. GP practices would have incentives to provide x-rays, tests and outpatient consultations within their practice or to commission these services from another provider. Savings from managing referrals more efficiently would be  reinvested into patient care. Further guidance on its implementation was issued.

It became policy that PbC should be universal and there were financial incentives to the practices that took part, for example additional staaff.  From April 2005, practices could hold an indicative commissioning budget from their PCT to manage the delivery of services for their patients.  Healthcare practitioners other then GPs, such as nurses, could also hold a budget.  For example community based nursing teams could hold budgets for groups like vulnerable adults. The advantages were said to be

• a greater variety of services from a greater number of providers, closer and more convenient to patients.

• encouragement of clinician to clinical discussion about improving care

• involving practitioners in service development

• a set of levers to aid demand management.

Recruitment

The RCGP and the BMA’s GP Committee thought that the growth in the number of doctors was nowhere near great enough to make possible the level of service Government wanted.  The number of doctors completing vocational training had been dropping and practices found it more difficult to recruit new colleagues.  In the 1970s & 1980s general practice was the first career choice of 40-50% of newly qualified doctors; this fell to 20% in 1996, but rose slightly to 25% in 2000. However GPs wished to retire earlier and the loss of a cohort of older GPs, many of Asian origin who had entered practice in the 1960s and 1970s was imminent. These doctors had often settled in less attractive areas that could ill spare them.  Efforts to increase the number of GPs were tempered by the fact that the majority of entrants to practice were now women frequently wishing to work part time. Indeed some of the popularity of general practice was the perception of a better life/work balance. Ten years previously there had been a move to encourage older doctors to retire, (implicitly GPs who might be out of date).  In March 2001, faced with the shortage of GPs and the commitment to increase their numbers, Alan Milburn, the Secretary of State, announced cash incentives to persuade them to stay.  There was a scheme to encourage GPs to work longer in the NHS, for example giving those aged 60 and over £2,000 per year up to a total of £10,000 over five years to continue working to 65, a £5,000 'golden hello' to every new GP who joined the NHS.

Vocational training to general practice was progressively developed to fit in to the framework of Modernising Medical Careers, and the in 2007 the Membership of the Royal College of General Practitioners was developed into a necessary requirement for entry into NHS general practice.

Since 1948 the Medical Practices Committee had worked effectively for an equitable distribution of GPs over the country, attempting to see that inner cities were reasonably served.  In April 2002 this committee was abolished under the Health and Social Care Act (2001).  Henceforth Primary Care Trusts would manage recruitment within national guidance.  PCTs were divided into groups, according to their number of GPs expressed in terms of weighted population.  All would be encouraged to recruit, although some should aim for larger increases than others, and all would have to do so within their financial allocations.  Given the shortage of GP entrants, it was probable that more attractive areas would have better luck.

Hospital services

Links on this page

Workload and bed numbers Waiting times Hospital reconfiguration and design Hospital building and the Private Finance Initiative Rating hospital trusts The effects of the NHS Plan on hospitals London

During the decade there were major changes in the hospital service. Workload increased but waiting times for outpatient appointments and for admission fell.  Systems to assess the quality of services were introduced, staffing was increased substantially, and although the number of beds fell steadily, hospital building increased mainly under public-private partnerships. Reconfiguration of services began. Hospital development had been been based upon planning and an assessment of local health needs.  The development of the 'market' in the 1990s led to a decline in this approach, replaced by business planning, financially driven, short term and institutionally based.  However as new policies, such as quality, clinical networks, patient choice and changes in financial flow were developed, this became  inadequate; significant analysis and forward planning was increasingly needed.  Financial stringency made reconfiguration of an area's services important.

For overseas readers who may not know much about the structure of the NHS The NHS inherited multiple hospitals, often small and in a bad state of repair, from local authorities and not-for-profit charities in 1948.  Over a period of years hospitals were closed, rebuilt and merged with the aim of providing a single district general hospital in each area, supporting local general practitioners and being supported by university and specialist hospitals.  In general such hospitals are 500-800 beds in size, operate to 90% capacity or more, and save in city centres have little competition.  There have been steady trends to increased throughput, and with sub-specialization the number of consultants has steadily grown.  The organisational framework within which the hospitals operate has repeatedly changed.  Currently they are managed by NHS Hospital Trusts and their budgets are determined mainly on payment by activity, using a tariff system.

Hospital episode statistics - England - 1998/2007   Source Health & Social Care information centre web site
Year	Ordinary admissions (1000s)	Day cases (1000s)	Increase
1995/6	8,371	2,845
1998/9	8,563	3,420
1999/2000	8,587	3,579	1.01%
2000/1