CURRÍCULUM VITAE ANTECEDENTES PERSONALES Apellido: Cueto Rua Nombres: Eduardo Angel Fecha de Nacimiento: 6/3/1947 Estado Civil: Casado Hijos: 4 Domicilio Calle: 56 Teléfono/Fax: 0221-4838662 Matricula Provincial: 12.996 E-Mail: ESTUDIOS REALIZADOS Y TITULOS OBTENIDOS Médico 25 de Marzo de 1971 Otorgado por la Facultad de Ciencias Médicas de la Universidad Nacional d
HealthTHE SOCIAL MARKET FOUNDATIONHEALTH COMMISSION – REPORT 2C The Commission would like to thank Niall Maclean for his hard work in preparing this report.
Members of the SMF Health Commission
Lord David Lipsey is Chairman of the Social Market Foundation. He is also Chair of the
British Greyhound Racing Board, and of Make Votes Count and of the Shadow Racing Trust;
and is a Non-Executive Director of the Advertising Standards Authority and London Weekend
Television. Lord Lipsey has previously served as a member of the Davies Panel looking into the
funding of the BBC, the Jenkins Commission on Electoral Reform and the Royal Commission on
Long Term Care of the Elderly. Prior to becoming a Peer in 1999, Lord Lipsey was Political Editor at The Economistand was formerly a Special Adviser to the Rt Hon Anthony Crosland.
Rabbi Julia Neuberger DBE was formerly Chief Executive of the King’s Fund. She is a
member of the Committee on Standards in Public Life and a Trustee of the Imperial War
Museum. She has been a member of the General Medical Council, the Medical Research
Council, a trustee of the Runnymede Trust and a member of the Board of Visitors of Memorial
Church, Harvard University. She holds honorary doctorates from ten universities, is an
honorary fellow of Mansfield College, Oxford and was Chancellor of the University of Ulster from 1994-2000. Shereceived a damehood in the 2003 honours list.
Professor Ray Robinson is a Professor of Health Policy at the London School of Economics
Health and Social Care Department. He is also currently chairman of the York Health
Economics Consortium. Prior to this he was Professor of Health Policy and Director of the
Institute for Health Policy Studies at the University of Southampton. Earlier in his career,
Professor Robinson worked as an economist in HM Treasury and was a Reader of Economics at
the University of Sussex. From 1990-1995 he was a health authority non-executive director and, from 1993-1995,Vice Chair of East Sussex Health Authority.
Dr Chai Patel CBE is Chief Executive of Priory Healthcare, the UK’s largest independent
mental health services group. He has been a member of the Government’s Better Regulation
Task Force and the Department of Health’s Task Force for Older People. Dr Patel is also a
Fellow of the Royal College of Physicians, a Fellow of the Royal Society of Arts, a member of
the Institute of Directors, a Companion of the Institute of Management and has received an
Honorary Doctorate from the Open University. In 1999 he was awarded a CBE in the Queen’s Birthday Honours Listfor his services to the development of social care policies.
Dr Bill Robinson is the Head UK Business Economist at PricewaterhouseCoopers. From
1978-1986, he was a Senior Research Fellow at the London Business School, and Editor of the
LBS Economic Outlook; from 1982-1986 he was a Special Adviser to the Treasury Committee.
From 1986-1991 he was Director of the Institute for Fiscal Studies. He also advised on the
Budgets of 1991-1993 as the Special Adviser to the Chancellor of the Exchequer.
Fergus Kee is Managing Director of BUPA’s health insurance businesses in the UK and Ireland.
He has worked for BUPA in a variety of roles since 1992. Prior to that he worked with Proctor &
Gamble, the Burton Group and KPMG.
Niall Maclean is a Research Fellow at the Social Market Foundation, and was involved in the
final drafting of this paper. Prior to the SMF, he worked as a Researcher in the Public Health
Sciences Department of King's College, University of London. During his time with King's he
published in several academic journals, including the BMJ and Social Science and Medicine.
The Social Market Foundation
The Foundation’s main activity is to commission and publish original papers by independent academic Defining a core package for the NHS: key points and other experts on key topics in the economic and social fields, with a view to stimulating publicdiscussion on the performance of markets and the social framework within which they operate.
The value of constructing and justifying a ‘core package’ of NHS services The Foundation is a registered charity and a company limited by guarantee. It is independent of any Constructing a core package: Is it feasible? political party or group and is financed by the sales of publications and by voluntary donations fromindividuals, organisations and companies.
Constructing a core package: A method for the UK The views expressed in publications are those of the authors and do not represent a corporate opinion of Chairman
David Lipsey (Lord Lipsey of Tooting Bec)
Members of the Board
First published by The Social Market Foundation, July 2004 The Social Market Foundation11 Tufton StreetLondon SW1P 3QB These beneficial consequences will, of course, count for nothing if the task of defining a core package of Defining a core package for the NHS
services is not feasible. We devote the second section of this report to assessing the feasibility of thistask, by drawing on evidence from home and abroad. KEY POINTS:
– Constructing and justifying a ‘core package’ of NHS services would bring significant benefits.
In the final section, we build on our findings on the feasibility question in making some Central amongst these benefits is the gain in honesty and transparency that would result from recommendations as to how the task of defining a core package of health care services ought to be any attempt to draw the boundaries of NHS provision. Furthermore, the taking of hard undertaken in the UK. We focus closely on the workings of the National Institute of Clinical Excellence, decisions about the scope of provision allows for resources to be directed at those services and its links to the National Service Frameworks. – However, the task of constructing and justifying a core package confronts serious problems of THE VALUE OF CONSTRUCTING AND JUSTIFYING
principle. In addition, research from abroad suggests that the task also faces important A ‘CORE PACKAGE’ OF NHS SERVICES
The NHS Plan (2000) states: ‘The NHS will provide access to a comprehensive range of services – In the face of these difficulties, we should adopt a cautious and pragmatic approach – we throughout primary and community healthcare, intermediate care and hospital based care. The NHS will ought to create the appropriate kind of environment in which the boundaries of NHS also provide information services and support to individuals in relation to health promotion, disease provision could gradually become clearer over time. prevention, self-care, rehabilitation and aftercare.’ The stark reality is, of course, that the NHS cannotsupply absolutely every treatment that has medical benefit. Nor has it ever been able to do so. And nor – In the UK, NICE ought to be an important part of this environment. However, it ought to be should it be ashamed of this fact – limitations on provision are an inherent feature of health services adequately resourced, be free of unnecessary political interference, become better at around the world (Honigsbaum et al 1995).
including wider societal values in its decision making, and be encouraged to link more closelywith National Service Frameworks.
However, the line between what is provided and what is not provided has never received an explicitjustification. These decisions have tended to be implicit, largely controlled by the medical profession, When the NHS was set up in 1948, it was on the basis of treatment according to medical need, rather than and rarely connected to agreed upon decision-making criteria. (New and Le Grand 1996). Some have ability to pay. Doing justice to this principle was thought to require three things. Firstly, it was thought that argued that these decisions are inherently ‘messy’, and simply cannot be governed by agreed upon the health service ought to be universal – all citizens were to be covered. Secondly, treatment was principles (Hunter 1995). This tone of pessimism has been sternly criticised by others, who argue that an supposed to be free at the point of delivery. Thirdly, the service was supposed to be ‘comprehensive’.
ad hoc approach leaves the door open to inconsistency, and does not fully serve the interests of patients,clinicians, or the wider community (Kennedy 1988). On the universality criterion, the NHS seems to have held up very well – all UK citizens are indeedcovered by the service. Regarding the second criterion, most treatment is free at the point of delivery, There is good reason to doubt whether a non-justified line between what is and what is not provided on the although the introduction of various user charges has meant that this does not apply in all instances.
NHS will be tolerated for much longer. The public is becoming better informed about health care issues.
They are up to date with developments in medical technology, and often have knowledge about the health What of the third criterion – that the NHS provides a ‘comprehensive’ list of services? While care services available in other countries. In short, they have high expectations of the NHS. When it is ‘comprehensiveness’ is a beguiling term that invites different interpretations, it is clear that a made clear that some particular treatment will not be available on the NHS, discontent is inevitably ‘comprehensive’ range of NHS services has never meant providing absolutely everything that has any expressed and often finds a ready media outlet. As the number of effective medical treatments grows, we medical benefit, no matter how small. The NHS has always excluded some treatments from its remit. At the can expect these instances of discontent to become more and more frequent. Commentators have warned inception of the NHS, when the range of effective medical treatments was still relatively small, the task of of an impending ‘legitimisation crisis’ for the NHS if these decisions are not seen to be made in a justifiable deciding what would be covered on the NHS might have been relatively straightforward. Much has changed manner (New and Le Grand 1996). An important way to retain confidence in the NHS is to present the over the last fifty years, however. Medical technology has advanced at an astonishing rate, and as a public with a set of NHS services that receives an explicit justification. By doing so, a coherent line of consequence the number of effective treatments has greatly increased. Organ transplants, new and more reasoning can be presented to justify the exclusion of certain treatments from the remit of NHS provision.
effective antibiotics, statins, new forms of chemotherapy for cancer – all these treatments are now commonly We perceive the key benefits of defining and justifying a core package of services for the NHS to be honesty provided on the NHS. Continuing advances in genetic technologies suggest that the increase in the number and transparency. Honesty begins with the open acceptance of the fact that the NHS never has been, and of effective treatments in the medical armamentarium is very likely to continue well into the future.
never will be, able to provide all services that confer medical benefit. Honesty will also be manifested in theprocess of constructing a core package, where difficult decisions are not shirked, and are dealt with in a The increased number of effective treatments has made the line between what is funded on the NHS and justifiable manner. Transparency ought also be manifested in this process – the decisions ought to be what is not – the limits to NHS ‘comprehensiveness’ – much more difficult to draw. Nevertheless, justified clearly and openly, and in a way that allows for on-going scrutiny.
constructing and justifying a set of treatments that ought to be provided by the NHS – a ‘core package’of services – would bring important beneficial consequences. In the first section of this report we will However, constructing a core package of NHS services will have additional benefits that go beyond these. The construction of such a package will, it is often argued, lead to better cost containment. As the BMA remarks in its Healthcare Funding Review of 2001, defining a core of NHS services would ‘enable The most marked resistance to the idea of constructing a core package comes from the Department of the public component of healthcare spending to be contained, whilst allowing other services to be Health. It has several arguments against, presented in The NHS Plan. Firstly, it argues that advocates for offered on a private basis to paying customers.’ defining a core service ‘usually have great difficulty specifying what they would rule out’. The sort oftreatments that commonly feature include varicose veins, wisdom teeth extraction, and cosmetic In addition to cost-containment, getting clear on the scope of NHS provision would allow for priority to procedures; services that account for less than 0.5% of the NHS budget and are not major cost-drivers be given to those services deemed most important. Resources could be preferentially directed to ensure for the future. In reality, the vast majority of spending goes on childbirth, elderly care, and conditions that these services are less rationed, and that their quality increases. such as cancer, heart disease, and mental health problems. It is certainly true that, when thinking aboutthe boundaries of NHS provision, certain ‘obvious candidates’ for exclusion are easy to discern – Defining clearly what is covered by the NHS means we will become clearer about what is not covered, and cosmetic procedures, for example. When pressed to specify which services ought not to be available on this latter form of clarity has the important benefit of allowing the private and voluntary health care sectors the NHS, the UK public often cite these very treatments and services as the ones to be excluded (Kendall to become more clearly defined. Suppliers will be consolidated, quality would probably increase, and more 2000; Bryson & New 2000; Mori 1998; Pollard & Raymond 1999; Kendall 2000). However, beyond these efficient payment mechanisms could emerge. Various forms of ‘top-up’ insurance might also emerge. obvious candidates for exclusion that seem to service wants rather than medical needs, there is very littleagreement. One good example of seemingly entrenched disagreement is over whether fertility treatment Finally, constructing a clearly defined package of NHS services can be seen as an excellent way to secure ought to be funded on the NHS (Mori 1999, ICM 1999).
the goal of uniformity in provision. If we have an explicitly delineated core package of services that oughtto be available in all health authorities, geographical deviations should become much less commonplace.
The second objection to the very idea of defining a core package of services presented in The NHS Plan While some geographical variations in service provision are acceptable (e.g. those that reflect the is that ‘different patients under different circumstances often derive differing benefits from the same particular needs of a specific locale), the blanket exclusion of some services from some areas clearly treatment’ (NP 3.30). The underlying argument here is that because different patients can receive offends equity and ought not to be tolerated (New and Le Grand 1996). different benefits from the same treatment it is difficult to rank treatments per se as being more or lessimportant. Genetic technology might, if it becomes sufficiently refined, be able to allow us to bettertarget certain treatments to certain patients, and could make it easier to make accurate generalisations CONSTRUCTING A CORE PACKAGE: IS IT FEASIBLE?
about the benefits wrought by specific treatments. This refinement of genetic technology remains someway off however, and even when refined it may be very costly to implement. As things stand at the So much for the beneficial consequences that would come from the construction and justification of a moment, those who seek to define a core package based on relative rankings of the benefits wrought by core package of NHS treatments. What reasons are there for thinking that this task is feasible? different treatments face a very difficult task. One important determinant of feasibility is the level of desire amongst the relevant stakeholders to see In addition to these problems confronting any attempt to define a core package of NHS services, there the task undertaken. Let us begin with the most important stakeholders – service users. The British are also significant practical difficulties. One thing that sets the UK apart from other countries on the public retain a strong belief that the NHS ought to provide an equal standard of healthcare across the issue of health care provision is the degree to which the NHS is politicised. In social insurance systems, country (BMA 2001, Health Which? 1999). Attitudes surveys also reveal that while the public would insurers will tend to define the core package at arm’s length from government, or else government will ideally like the NHS to provide all the treatments they need regardless of cost, they are aware of provide only a broad framework of important treatments areas (allowing insurers to fill in the details budgetary constraints and are accepting of the inevitability of some form of rationing (Bryson & New regarding specific treatments). In the UK, defining a core package is seen as politically dangerous – it is 2000). The public have been exposed to implicit rationing in the form of waiting lists almost since the perceived as being equivalent to a contract between government and citizens that could prove inception of the NHS, and have occasionally been presented with high-profile cases of explicit rationing uncomfortable should the health service fail to deliver. (the child B case in Cambridge, for example). These political fears certainly count as one sort of practical difficulty standing in the way of any attempt to For its part, The British Medical Association (in its Healthcare Funding Review of 2001) described the define a core package of publicly funded health care interventions in the UK. The experiences of other idea of introducing a package of core services as ‘superficially attractive’, adding that ‘if we acknowledge countries that have attempted the task highlight further practical problems. Perhaps the best-known attempt that rationing and denial of treatment already exist within the NHS, the definition of an explicit boundary to define a core package of health care services was undertaken by the state of Oregon (USA) in 1989. The seems a small step to take.’ In addition to the BMA, the National Consumer Council (2003) has Oregon Health Plan was the result of a legal initiative undertaken by a group made up of service users, recommended a ‘Core Services Commission’ to decide what should be covered by the NHS. providers, insurers, business people, and labour representatives. Its aim was to ensure universal access toreasonably priced health insurance, partly by widening Medicaid coverage to all residents of the state. The Legally, there seem to be few barriers to the construction of a core package. Although some driving idea was that universal coverage would only be achievable if cost-containment mechanisms were consideration will have to be given to the Human Rights Act, analysts have concluded that, based on legally mandated. One of these mechanisms consisted in limiting the set of conditions for which treatment previous experience, it seems likely that UK courts will recognise the need for health authorities (and would be available. A Health Services Commission was established to rank conditions and treatments their successors) to set priorities, given limited resources. They are therefore expected to give some according to certain designated criteria. Universal coverage would be provided above a certain threshold leeway in resource allocation decisions, as long as these decisions do not discriminate unfairly and can (the threshold depending on actuarial estimates and budgetary constraints during any particular session of be shown to have been made in the best interests of the wider community (Thomson et al, 2001).
the state legislature). Mental health services have been included in the prioritization process since 1995.
The ranking criteria used by the Commission have evolved over the years. Initially, four criteria were CONSTRUCTING A CORE PACKAGE: A METHOD FOR THE UK
used: cost, net duration of benefit, physician estimates of the probability that treatment would alleviatesymptoms or prevent death, and citizen opinions concerning the severity of symptoms. The rankings that Thus far, we have argued that, while the construction and justification of a core package of NHS services emerged from these criteria were so heavily criticised that the Commission decided to put primary weight is an attractive idea, it faces certain problems of principle, as well as practical difficulties. How ought the on the values of citizens expressed at community meetings. As a result of this development, the federal UK to proceed in the face of these difficulties? It would seem that there are two possible courses of government charged the Commission with violating the Americans with Disabilities Act, since the action. The first course is to admit defeat – the difficulties are simply too great, and we should therefore weights attached to conditions of people with disabilities depended on the opinions of the non-disabled.
give up on defining a core package. The second course could be described as cautious pragmatism.
The methodology was revised once again, with most emphasis being put on the likelihood of a While acknowledging the seriousness of the difficulties that seem to attend any attempt to define a core treatment’s preventing death or alleviating symptoms, and on cost, with adjustments then being made in package in the here and now, this approach would recommend that we attempt to move forward the light of citizen values. Such adjustments were later removed.
cautiously, in incremental steps. While we might not at the moment be able to construct a core packageof NHS services, we can nevertheless take certain steps to at least allow the boundaries of NHS provision The Plan has had some success: the proportion of uninsured Oregon residents fell from 18% in 1993 to to become more clearly defined over time. This is the approach we favour. 11% in 1996 (although economic growth must also been seen as playing a role in explaining this fall).
However, it has also provided some stark examples of the practical difficulties that await any attempt to How ought this incremental approach to begin? The best way to begin is not, it would seem, to focus define a core package of clinical services. straight away on the kinds of treatments that immediately arouse controversy (e.g. fertility treatment).
Rather, we ought to begin by looking for areas of substantive agreement, and then work outwards until Firstly, it is important that the values of citizens are reflected in the prioritisation process. This is a we reach disagreement. We ought to start by asking ‘Which services do we think absolutely ought to be daunting task, since diverse societies such as ours are marked by a plurality of reasonable and competing provided by the NHS?’ In answering this question, we will most probably end up with a set of values. The Oregon planners have relied on community meetings to draw upon popular values.
interventions comprising the majority of the services currently provided by the NHS. The number of Commentators on this process have questioned the representativeness of these meetings, and have treatments over which there would be disagreement is likely to be relatively small. As NERA & Norwich highlighted the difficulties that surround any attempt to draw balanced conclusions from their findings Union Healthcare (2000) state: ‘It seems likely that most of what the NHS currently provides would be (Klein 1999). In the UK, there has been some recent interest in the use of ‘citizen juries’ as a means of included and exclusions would focus on areas where there is already disagreement (e.g. as evidenced by tapping into the relevant kinds of popular values (Leneghan et al 1996). As yet, however, there is no geographical discrepancies in funding and provision across the UK).’ The set of interventions they consensus regarding the best way to make such juries representative, or on how to draw justified suggest would meet with broad agreement includes those that are of proven effectiveness and meet agreed value for money criteria, as well as intermediate care and elements of long term care, plus someelements of social care like residential care for the elderly (Nera & Norwich Union Healthcare 2003).
Secondly, the Oregon experiment has shown that establishing an explicit limit on service coverage is very Treatments of limited efficacy or for conditions that patients can reasonably treat themselves (e.g. colds, difficult in practice. Many Medicaid recipients are reported to continue to receive services that are hay fever and minor injuries) are likely to be excluded. supposedly excluded by the Health Plan (Oberlander et al 2001). Ham (1998) cites this as strongevidence in favour of the idea that the definition of a core package must be supplemented with clinical Thus, by adopting a method that begins by looking at treatments we absolutely want to be covered by the guidelines governing how the treatments in the package are to be provided. The necessity of such NHS and working outwards, we are likely to arrive at a set of interventions made up of many of the guidelines shows the clear difficulties in excluding entire categories of care from the remit of public treatments currently provided by the NHS. This is far from a pointless exercise, since the set of NHS treatments can now receive a justification – it has been put together via a process where we think aboutwhat we absolutely want to be covered. The values of transparency and honesty we described above Thirdly, Oregon has shown that the work of defining an explicit package of services must be ongoing.
would be well served by this process.
This is so because of the continued rapid advance of medical technology resulting in the continuousemergence of new treatments, and also because new information about the effectiveness of existing The serious question that remains is how we proceed when we hit disagreement – when we are treatments is constantly being produced. An ongoing evaluation process is complex and time confronted with a treatment that might be worthy of inclusion in the NHS package. We know how the consuming. In January 1998, the Oregon Health Financing Commission still had to approve revisions to cautious incremental approach ought to begin – by working outwards from substantive agreement to the priority list that had been drawn up in May 1997 (Ham 1998). disagreement. But how ought it to proceed when we hit these disagreements? It is our view that, while wemight be some distance away from arriving at justifiable decisions in all these instances of controversy, Other countries that have undertaken the task of defining which health care services ought to receive we can however create the right environment that could allow these decisions to be made over time in an public funding have encountered similar practical problems. In 1992, New Zealand established the honest, transparent, and justifiable manner. National Advisory Committee on Core Health and Disability Support services. In the same year, theDutch government’s Committee on Choices in Health Care produced its final report. In both instances, We believe that the National Institute for Clinical Excellence ought to form an important part of this the significant practical problems that were found to attend attempts to define a core package led environment. The central operative concept used by NICE is ‘cost-effectiveness’ – it claims to ‘help the planners away from the construction of such a package towards the delineation of broader guidelines to NHS to deliver the best possible health care from available resources, by focusing on the most cost- effective treatments (www.nice.org.uk/Article.asp?A=256). Thus, in deciding whether a treatment is suitable for provision on the NHS, NICE considers whether the treatment is sufficiently cost-effective.
ought to be equipped to make decisions about not only the marginal cases, or for new treatments. The This immediately begs the question: how cost-effective is ‘sufficiently’ cost-effective? Where exactly does values of transparency and honesty we discussed in section one would be greatly served were NICE to be the threshold lie? The recent much-publicised example of the multiple sclerosis treatments beta equipped to give justifications for the inclusion of the treatments currently provided by the NHS.
interferon (BI) and glatirimer acetate (GA) can bring out the issues that must be dealt with in properly Undertaking this task would demand even more resources – but the benefits would be significant. We cashing out the concept of cost-effectiveness. might reasonably expect this exercise to lead to the exclusion or more selective usage of certaintreatments that are in fact of limited effectiveness (or are effective only with carefully selected patients).3 In its ‘provisional view’ published in July 2000, NICE stated that neither BI nor GA ought to receive NHS The saved costs could be diverted to more effective treatments. funding because their ‘modest clinical benefit appears to be outweighed…by very high cost.’ The costeffectiveness of a treatment is equal to the clinical benefit of the treatment divided by its cost. NICE Secondly, we ought to be prepared to accept that cost effectiveness considerations might not be the only clearly believes the ratio in the case of BI and GA is not suitable, but is not clear exactly why it believes ones that ought to feature in any attempt to give a justified account of where the boundaries of NHS this. At section 4.15 in its Final Appraisal Determination on these drugs (produced in November 2001), provision should lie. One of the key lessons of Oregon is that the values of the wider community (which NICE estimates that the mean cost per quality adjusted life year (QALY) gained by using these drugs is might include, but are surely not exhausted by, notions of cost effectiveness) must feed into the between £248,000 and £810,000 at five years, between £210,000 and £339,000 at 10 years, and justification of decisions about what kinds of health care we want to make available. However, as we between £35,000 and £104,000 at 20 years.1 It is clear that NICE does not find these ratios of costs-to - remarked above, the task of sampling of these values, and of arriving at agreed-upon decisions from the QALYs to be acceptable, but what is lacking from the FAD is any attempt to explain why they are plurality of reasonable values that exist in our society, is an extremely challenging one. It is not, however, an impossible task. Recent research has suggested that individual citizens can and Specifying a threshold ratio of clinical benefits versus financial costs might well be a good way of ought to be consulted regarding the kinds of values (and trade-offs between values) that ought to shape deciding which treatments ought to be provided by the NHS. However, exactly where the ratio should be the workings of the NHS (New and Neuberger 2002). It is important that the task of consulting wider struck, or even how it ought to be struck, receives strikingly little attention in NICE’s self-documentation societal values is undertaken, either under the auspices of NICE, or via another organisation that feeds of its working practices.2 While one NICE document states that ‘Clinical guidelines should…address the its findings into the workings of NICE. Towards the end of 2002, NICE set up a Citizen’s Council, made cost effectiveness of treatments or management approaches (that is, how well they work in relation to up of 30 members of the public drawn from a wide range of backgrounds and coming from different parts how much they cost)’ (The Guideline Development Process: Information for the Public and the NHS, of England and Wales. The purpose of the Council is to feed the values of ordinary citizens into NICE’s p8), there is no specification of what sorts of cost effectiveness ratios are acceptable, and no systematic decision making processes. Although NICE is not bound by the Council’s advice, it claims to be attempt to derive and justify these ratios. ‘committed to this type of input’ (NICE 2002). We welcome this move by NICE, but we also await withinterest a forthcoming evaluation of the success of the Citizens’ Council (‘Evaluation of the Citizen’s The lack of clarity regarding exactly how NICE reaches its decisions is becoming increasingly well known Council of NICE’: National Co-ordinating Centre for Research Methodology, University of Birmingham.
– the Consumer’s Association has recently published a study highlighting these issues (BMJ Due to report in September 2004). The success of the Citizen’s Council is vital in allowing wider 2001;323:1324). An academic study of the 22 health technologies on which NICE had issued guidance by societal values to feed into NICE’s decision making. We urge continued support for this group, and, March 2001 ‘could not conclusively establish how the balance between clinical benefits and economics where relevant, amendment of its practices to further the aim of referencing the values of the public at (cost per QALY) influences NICE recommendations’ (Raftery 2001; parentheses in original). Even more recently, a World Health Organisation report on NICE’s working practices (which was, in the main,complementary) has called for clarity regarding where NICE’s cost effectiveness threshold lies, and the Another lesson taught by Oregon is that the task of deciding which interventions ought to be provided provision of an explicit justification for this threshold (World Health Organisation 2003). If NICE must go hand in hand with the task of constructing guidelines to be used in the appropriate prescribing continues to make its decisions on the basis of cost-effectiveness calculations, the justification of of these interventions, to decide on such issues as which patient groups are to receive which particular cost-effectiveness ratios is imperative. treatments, under what conditions, and for what duration. Nera and Norwich Union Healthcare (2003)rightly remark that any set of publicly funded health care goods should be well defined, comprehensive Although it is beyond the scope of this paper to suggest what these ratios might be, or how they might and consistent, so that there is no scope for shifting costs between different parts of the health system be justified, we can make some suggestions about how NICE as an organisation ought to be equipped to or for erosion of the set of goods. However, some element of clinical discretion ought to be preserved, meet these challenges. We are committed to the continued existence of NICE as an important part of the so that doctors could offer certain treatments outside the set to carefully selected patients who have a environment in which decisions about the inclusion or exclusion of treatments we disagree about can, capacity to benefit. This kind of flexibility over how publicly funded treatments are delivered is over time, be formed and justified. However, we believe it is important to recognise that NICE ought to be amended in various ways in order to become an effective part of this environment. A key challenge for NICE is to link better with existing National Service Frameworks (NSFs), which are Firstly, it ought to be properly resourced. The generation and justification of cost benefit ratios, and the designed to ensure national standards of care for specific services and disease groups. Recently, subsequent application of these ratios to all the treatments deemed to be ‘marginal cases’ for inclusion concerns have been raised over how well NICE links with NSFs (‘NICE needs sweeping changes to under the remit of the NHS, constitutes a significant amount of work. NICE ought to receive a maintain credibility, say MPs’, BMJ 2002;325:5 [6 July]). Improving these links is an essential proportionate amount of additional resources to undertake this work. Furthermore, we believe that NICE prerequisite in ensuring that the elements of any core package are supplied in a justifiable fashion. Furthermore, there is some evidence to suggest that well-functioning guidelines for the treatment of these boundaries could – over time – become clearer. We believe that NICE must be a central part of this specific conditions also facilitates the sort of comparisons in cost-effectiveness between different types environment. However, it must be properly resourced, be given an appropriate amount of autonomy from of treatment that are the cornerstone of NICE’s working practices. Citing the example of the Kaiser unnecessary political interference, and adequately reflect wider societal values in its decision making.
Permenente Health Plan in the US, Feachem et al (2002) describe how these kinds of close links Initially, if NICE were to provide a clear justification for the inclusion of the bulk of the treatments between clinicians and administrators allow for a level of control and accountability across an entire currently provided by the NHS, this would constitute a significant gain in honesty and transparency. health care system, which in turn facilitates trade-offs in expenditures based on cost effectiveness ratherthan ‘artificial budget categories’. Another key task in the short term is to make NICE link better with National Service Frameworks, inorder to create guidelines for the appropriate provision of the treatments we agree ought to be within the Finally, NICE ought to operate free from unnecessary political interference. In the Guide to the Technology Appraisal Process, NICE states that the process of weighing the costs and benefits of a newtreatment must take into consideration ‘the Secretary of State’s and the National Assembly for Wales’ By adopting this cautious and pragmatic approach we believe that the boundaries of NHS provision broad clinical priorities (as set out for instance in National Priorities Guidance and in National Service could become sharper over time. The advantages of undertaking this task are significant enough as to be Frameworks…)’ and ‘any guidance from the Secretary of State and the National Assembly for Wales worth waiting for – the ‘comprehensiveness’ of the NHS would become more clearly cashed out, rather [NAW] on the resources likely to be available and on such matters as they may think fit’ (Guide to the than remaining in its current murky state.
Technology Appraisal Process, p2). The Department of Health and NAW also ‘provide NICE with a remitfor the appraisal’ (Ibid. p6), and NICE’s appraisal is expected to be ‘in accordance with the terms of the The QALY approach can be summarised thus: each year of perfect health is valued at 1 and each year of illness at less than 1, with more Department of Health/NAW’s reference’ (Ibid. p13). Since NICE makes recommendations about how severe illnesses lowering this value by greater amounts. Treatments are then costed per QALY gained. The use of QALYs in the case NHS services – which are publicly funded – ought to be prioritised, it is important that its decisions are of BI and GA is described by NICE in the Final Appraisal Determination in this way: ‘The number of QALYs gained by using a particulartreatment is a measure of its benefits in terms of improvements in the quality of life of patients (including physical performance, pain, democratically accountable. This might require, for example, ministerial approval of its decisions.
distress, and psychological improvements, as well as changes in survival) summed over a period of time.’ (Appendix E, A1.1.1). However, it is important that NICE enjoys (and is seen to enjoy) the freedom in its day-to-day work to Some commentators believe NICE operates with a threshold ratio of £30,000 per QALY gained (e.g. Taylor ). Even if this is the make the kinds of decisions that might not meet with short-term political approval, but which are figure NICE has settled on (and there is no conclusive evidence to suggest it is), it ought to be justified.
When evidence about the effectiveness of grommets for persistent glue ear in children was distributed nationally in 1992, the rate nevertheless necessary in the construction and justification of the boundaries of NHS care. Public of grommet insertion fell steadily. In the four years after the evidence was distributed, 89, 800 procedures were avoided, providing confidence in NICE would be severely damaged were this freedom to be encroached upon by a theoretical saving of 27m GBP at 1992-3 prices. (Mason et al ) THE COMMISSION’S VIEW
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