■ COLLEGE LECTURES

Pharmacopolitics and deliberative democracy

Michael D Rawlins

ABSTRACT – Setting priorities in healthcare has Distributive justice in healthcare

become a highly politicised activity. Traditionally
it has been undertaken by government and the The approaches that societies might most appropri-
health professions but there is an increasing ately take in the distribution of their available
imperative to involve the public. The National resources are described by political and moral
Institute for Health and Clinical Excellence (NICE) philosophers as the problem of distributive justice.
has established a Citizens’ Council as an attempt Three moral theories of distributive justice –
to capture the informed views of the public in libertarianism, utilitarianism and egalitarianism –
shaping the Institute’s social value judgements. have a particular resonance for setting priorities in
Although, in the future, better ways of involving healthcare.4
Libertarianism is based on the premises that indi- This paper is
the public may emerge, NICE’s approach repre-
viduals should be able, and expected, to finance their based on the
sents one way in which ordinary citizens can Samuel Gee
engage in the process of prioritising healthcare. healthcare through their own efforts and that market
Lecture given at
forces should enable them to do so at a reasonable
the Royal College
KEY WORDS: distributive justice, NICE, price. With the commitment of the National Health of Physicians on
pharmacopolitics, procedural justice, social value Service (NHS) to social solidarity, libertarianism has 21 March 2005 by
judgements in healthcare little to offer as a solution to the problem of Professor Sir
distributive justice for the UK’s healthcare system. Michael Rawlins
Utilitarianism in its purest form considers distrib- MD FRCP FFPM,

One of the features of modern pharmacology is the utive justice to be best served by maximising social Chairman, National
utility. Utilitarians expect expenditure on health to Institute for Health
range and number of subdisciplines it has spawned,
be distributed in a manner that maximises the and Clinical
including pharmacokinetics, pharmacogenetics, Excellence,
pharmacoepidemiology, pharmacovigilance and welfare of the population as a whole. The principle is
London; Professor
pharmacoeconomics. There is now emerging interest often expressed as ‘the greatest good for the greatest
of Clinical
in pharmacopolitics.1,2 number’ and has unquestionable attractions. It
Pharmacology,
Politics generally is about expressing and resolving places a premium on the efficiency of a healthcare Wolfson Unit of
conflicts within society without recourse to physical system, and it asserts that using ineffective or costly Clinical
violence.3 The subject of pharmacology has become interventions in one area of medical practice will Pharmacology,
politicised to a greater extent than any other bio- remove the availability of cost-effective interventions University of
medical discipline because of its global importance in another. Newcastle
and impact and the controversies that the discipline Utilitarianism, however, has disadvantages. It can
arouses. Pharmacopolitics is concerned, for example, allow the interests of minorities to be overridden by Clin Med
with finding an appropriate balance between the the majority. It has little to offer in eradicating health 2005;5:471–5
risks and benefits of drug therapy, with resolving the inequalities. Its emphasis on efficiency can, more-
competing claims of profit for the pharmaceutical over, produce perverse solutions. The prioritised list
industry and the wider public interest, and with of healthcare services in the scheme developed by the
determining how or whether society should attempt State of Oregon, USA, based on efficiency, produced
to control the use of drugs for recreational purposes. a rank order that most would consider unaccept-
This article is concerned with a different able;5 tooth-capping, for example, was ranked above
pharmacopolitical problem. How, as a society, emergency surgery both for ectopic pregnancy and
should we set priorities for the medicines we use? for acute appendicitis. Utilitarianism, therefore, is
Although this question is a microcosm of the general not a panacea for setting priorities.
debate about setting priorities in healthcare, the Egalitarianism is about fairness, either in equality
difficulties and possible solutions apply equally to of opportunity or in equality of outcome. What is
other aspects of modern medicine. sometimes known as ‘qualified egalitarianism’ seeks
for resources to be distributed so that each can have
a fair share of the opportunities available in a partic-
ular society. This has become known as the ‘fair

Clinical Medicine Vol 5 No 5 September/October 2005 471

Michael D Rawlins

opportunity rule’. This rule was developed by the American those that fair-minded people would agree are relevant for
philosopher John Rawls,6 whose work, although not concerned meeting healthcare needs, especially in circumstances where
specifically with healthcare, has been interpreted as equality of resources are constrained. A particular feature of this condition
access to adequate care.7 is its focus on the importance of deliberation about the limits of
However, egalitarianism has its problems. The definition of the common good. It emphasises that deliberative democracy
‘adequate’ healthcare, the distinction between what is fair and needs to involve not only decision-makers but also the people
unfair, and the distinction between the unfair and the unfortu- who may be affected by the decisions. For the NHS, this must
nate all lack clarity.4 Similar problems confront the NHS: the mean both current and future patients. Moreover, the need to
NHS Act (1977) places a duty on the health service to provide involve the public is heightened by the fact that the service is
care that is ‘necessary and appropriate’ without defining clearly funded through general taxation.
what is either ‘necessary’ or ‘appropriate’. ‘Revision’ refers to the premise that there must be opportuni-
The tensions between utilitarianism and egalitarianism can be ties for challenging decisions and mechanisms for resolving
overstated. Many utilitarians accept that social values could (and disputes. ‘Regulation’ requires that there should be either volun-
should) be incorporated into their approach to distributive jus- tary or statutory regulation of the process, in order to ensure
tice. Qualified egalitarians accept the concept of ‘opportunity that the three other conditions are met.
costs’, with all its moral implications. There is, however, no The processes that the National Institute for Health and
formal synthesis of these two theories of distributive justice. Clinical Evidence (NICE) has adopted in developing its
Both theories clash at some point with the convictions of many guidance match, in most respects, the Daniels-Sabin conditions
people, but each articulates ideas that most would be reluctant for ‘accountability for reasonableness’. I believe that the broad
to relinquish. Often, where one theory is weak, the other is support that NICE has gained from the professions, the public
strong.4 and politicians of all persuasions is due to the Institute’s adop-
In the absence of a unifying moral principle underpinning tion of these. This has given NICE a legitimacy that it would not
distributive justice in healthcare, a groundswell of opinion has have acquired otherwise. This does not mean that the advice of
emerged that believes that if there is to be confidence in the NICE is not sometimes controversial: it is, and it always will be.
legitimacy of decisions on setting priorities, then some middle
way has to be found.
Scientific and social value judgements
The setting of priorities in healthcare requires two types of
Procedural justice
judgement to be made.12 Scientific value judgements are
This ‘middle way’ is procedural justice. Rather than debate concerned with interpreting the significance of the available
interminably the merits and demerits of utilitarianism and scientific and clinical data. Experts do not, however, base their
equalitarianism, there has been a move among some political conclusions solely on the basis of evidence. While evidence
and moral philosophers to outline the procedures for setting (rather than intuition and prejudice) is crucial, the evidence
healthcare priorities that allow the best of both theories to be base is never enough: judgements also have to be made. In the
accommodated within decision-making processes. Procedural context of medicines, experts have to make judgements about
justice is an uncomfortable concept for some people; it has been issues such as the validity of a surrogate marker as an indicator
described as ‘muddling through elegantly’.8 Procedural justice is of real therapeutic benefit, and whether the results of formal
an attempt to achieve a pragmatic resolution to the demands of randomised controlled trials can be generalised to routine
utilitarianism and egalitarianism. clinical care.
Norman Daniels, a bioethicist, and his colleague James Sabin, Social value judgements, however, relate to society rather than
a psychiatrist, have proposed that procedural justice for setting basic or clinical science.12 They take account of the ethical
healthcare priorities requires four conditions to be met if principles, preferences, culture and aspirations that should
decisions are to meet their test of ‘accountability for reasonable- underpin the nature and extent of the care provided by a health
ness’.9 Daniels and Sabin assert – and others agree with their service. They include matters such as whether special priority
approach10 – that if priority-setting is to gain broad acceptance should be given, by the NHS, to children and young people, and
and legitimacy, then the process must ensure publicity, whether the health service should be prepared to pay premium
relevance, revision and regulation.9 prices for drugs to treat very rare serious diseases.
‘Publicity’ requires that both the decisions themselves and the Scientists and clinicians involved in priority-setting should be
reasons for making them are made public. This in turn means selected for their ability to make scientific value judgements and
that the evidence underpinning decisions should be in the to evaluate evidence. In general, the public appears to accept
public domain – a condition that too often has been honoured that judgements of this type are best made by those who are
in the breach, especially as far as pharmaceuticals are concerned. experts in the underpinning disciplines.12 Expert scientists and
Transparency of decision-making is, therefore, crucial. clinicians, however, have no special legitimacy to impose their
Chalmers is right when he asserts that failure to place the results own social values on the NHS. These should reflect those held
of a clinical trial in the public domain is unacceptable.11 by people who are using, or who will use, the service. Only in
‘Relevance’ insists that the grounds for making decisions are this way can legitimacy be earned and retained. The question,

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 Pharmacopolitics and deliberative democracy

therefore, is not whether but how the views of the public should It was felt that a larger number of participants were required
be taken into account. so that the group could be more representative of a cross-section
of the adult population. The size chosen (30 members) was a
compromise: anything less would have made it almost impos-
Ascertaining the social values of the public
sible to achieve broad demographic representation; much more
If, as I assert, the social values of the NHS should reflect broadly would, in our judgement, have seriously diminished the
those of the public, then how might these be acquired? Various prospect of real deliberation between members.
approaches have been advocated.13 It might be claimed that this Additionally, in order to achieve continuity, NICE decided
should be the role of either Parliament or the government of the that rather than assemble a new group for each meeting (the
day. Parliament makes laws, raises taxes and decides how tax convention for citizens’ juries), members would be appointed
revenues should be spent. Whether it has any special legitimacy for three years, with one-third retiring annually. This would
to make social value judgements for the health service is unclear. allow members to gain knowledge of the health service and
Experience suggests that politicians find it extraordinarily NICE and to gain experience in deliberation. A changing
difficult to make such decisions in the face of electoral pressures. membership would also ensure that the Council would be
Public meetings are a time-honoured way in the NHS to refreshed annually with new blood.
sound out public opinion. They provide little opportunity, how- NICE was particularly anxious to avoid contaminating
ever, for reflection or deliberation, and attendees are usually members’ views with its own prejudices. To avoid ‘capture’, it
dominated by those with a vested interest in the issue under arranged for the meetings to be facilitated by an independent
discussion. organisation, with only one or two members of its staff present
Opinion polls and surveys, when conducted competently, can throughout the meetings.
elicit the public’s immediate preferences on particular issues. Finally, because these efforts at deliberative democracy were
Responses, however, may be coloured by inaccurate current untried, an independent organisation was commissioned to
media activity, and there is no opportunity for discussion or evaluate the scheme. This has now been completed.15
considered thought. Replies, moreover, are exquisitely sensitive Members of the Council were recruited by advertisements in
to the precise manner in which the question is phrased or the national and regional media. Applications were encouraged
framed. Polls and surveys do not provide the public’s considered from anyone, provided that they were not involved personally in
conclusions based on deliberation about the complexities healthcare or the healthcare industries. Thirty-five thousand
surrounding priority-setting in healthcare. people expressed an initial interest, and nearly 4,500 made full
A better understanding of the reasons underlying the public’s applications. Those appointed reflected the demographic struc-
immediate preferences can be elicited from focus groups. These ture of England and Wales, with respect to gender, age, ethnic
groups provide insights into why the public feels as it does. background, socio-economic status and disability. Their ages
Focus groups, however, are an extension of polling, and the time ranged from 18 to 76 years. Members included a cab driver, a
available (usually not more than two to four hours) does not scaffolder, a single parent and a retired airline pilot.
allow much opportunity for discussion and deliberation.
A more promising approach has been the use of citizens’
The Council and its reports
juries.14 In this technique, between 12 and 16 members of the
public are asked a question, often framed as it would be in a The Council has produced four reports.16–19 What have they
criminal trial, ie as a ‘charge’. Juries usually meet over three to said? What has been done with them? What lessons has NICE
four days. They are often provided with background material learned? And what will NICE do in the future?
and they are always, as in a legal trial, given the opportunity to The first report,16 on ‘clinical need’, was deliberately more
cross-examine expert witnesses. They are provided with time to discursive than the others. Its primary purpose was to identify
deliberate among themselves. At the end, they produce a areas where the Council’s views would be most useful and
‘verdict’. Citizens’ juries have been used widely to elicit the views relevant to the Institute and its advisory committees.
of the informed public on a wide range of policy issues in the The question posed in the second report,17 and emanating
USA, Germany and Britain.14 Coote and Lenaghan showed that directly from the first report, was: ‘Are there circumstances in
UK citizens can engage and deliberate on difficult matters which the age of a person should be taken into account when
related to healthcare and that they can reach well-argued and, in NICE is making a decision about how treatments should be used
some cases, novel conclusions.14 in the National Health Service?’ Previous work based largely on
polling had suggested that the public is very uncertain as to how,
or even whether, age should be taken into account in setting
NICE Citizens’ Council
healthcare priorities.20 For this reason, six days (spread over two
When NICE was set up in 1999, it was appreciated that, at some three-day meetings) were allowed for the Council to discuss and
stage, the Institute would need to establish the social values that reflect on the issue. The Council’s conclusions were as follows:17
would inform its advisory bodies. NICE was impressed by the First, health should not be valued more highly in some age groups
experience of citizens’ juries but believed that the approach had than in others, ie one year of life is of the same ‘value’ whether a
to be modified if it was to meet the requirements of NICE. person is 3 years old or 83 years old. Second, individuals’ social

Clinical Medicine Vol 5 No 5 September/October 2005 473

Michael D Rawlins

roles at different ages should not influence considerations of cost- 1 The disease should be severe or life-threatening.
effectiveness, ie people with young children and people with 2 The treatment should produce real and demonstrable
special professional responsibilities should not be given priority. improvements in health.
Third, where age is an indicator of either benefit or risk, discrim-
3 Some limit had to be placed on the amount that the health
ination (either positive or negative) is appropriate; the targeting
service should be asked to pay for these treatments in the
of people aged over 65 years for influenza immunisation is an
future.
example of this approach.
By a separate but parallel process, the Council also had the A minority (7 of 27) of the members, however, did not
views of nearly 200 children available to them. These were consider it appropriate for the NHS to pay such premium prices
derived from a special study undertaken by the National to treat people with these very rare diseases. Although very
Children’s Bureau.17 Children reached similar conclusions. sympathetic to the plight of individuals, they were concerned
The Council’s third report was about the use of confidential about the opportunity costs for others.
clinical data by each of the three national confidential The views of the Council are important. While accepting the
enquiries.18 At the time the question was put to the Council, need (on the grounds, in effect, of Rawls’ ‘fair opportunity rule’)
NICE had overall responsibility for their conduct and funding. for the NHS to pay exceptional prices, they also accepted that
From 1 April 2005, this role has passed to the National Patient there must be limits. When presented with the facts and an
Safety Agency. The enquiries use the medical records of patients opportunity to deliberate on them, people understand and
without the knowledge or consent of either them or their accept that a publicly funded healthcare system cannot provide
families. Although they are anonymised for analysis, patient unrestricted resources without incurring unacceptable penalties
identifiers remain during the collection and collation of for others.
personal medical records.
The use of medical data for research purposes, without Discussion
seeking permission, has attracted criticism. NICE needed to
know whether this practice, at least in respect of the confidential The Council’s conclusions have been embodied in a document,
enquiries, had public support. Much of the enquiry work intended for those who develop NICE guidance, to use as a
involves scrutiny of the records of deceased patients, and it had point of reference on social value judgements. Like all NICE
been felt that seeking consent from families would consume guidance, this document will not mandate our advisory com-
considerable resources and be intrusive. The majority of the mittees and guideline development groups, for sometimes there
Council, having heard evidence from many sources, concluded may be very good reasons to override them. However, NICE
that the enquiries should not be required to seek prior informed does expect its advisory bodies to adopt the principles and to
consent before using patients’ medical records.18 Despite the explain the reasons for any significant departures from them.
overall positive verdict, a minority of members, although recog- I have learned much from my attempts at promoting deliber-
nising the value and importance of the enquiries, felt un- ative democracy, but three issues are striking. First, people who
comfortable about using patients’ medical records without their volunteer for this type of endeavour are unquestionably forth-
knowledge or consent. This is a warning. Although most right and unafraid to express their views. In this respect at least,
members of the Council accepted in this case that the ends they may not be representative of the general population.
justified the means, this should not be assumed. Second, at the start, some members were clearly suspicious
At its most recent meeting, the Council was asked whether the about the motives behind the establishment of the Council.
NHS should be prepared to pay premium prices for drugs to Although they were pleased to be invited to take part, some
treat very rare diseases.18 Funding extremely expensive treat- suspected that they might be being used – that at best their views
ments for very rare diseases poses a dilemma for all healthcare would be ignored and that at worst they would be expected to
systems. Enzyme-replacement therapies for conditions such as endorse decisions that had already been made. I believe all
Gaucher disease and Fabry’s disease may cost between £50,000 members of the Council now accept that NICE is making a
and £200,000 per patient per year. These sums are an order of genuine attempt to reach out to the public, but their attitude
magnitude greater than those ordinarily accepted by the emphasises the gulf between those who make decisions and
appraisal committee of NICE as being cost-effective for the those who are affected by them. It is an example of what some
health service. Although there are no more than a few hundred call the ‘democratic deficit’. And it is a warning, not only to those
patients with these conditions, the overall budgetary impact involved in healthcare, of the public’s distrust of those they
may run to tens of millions of pounds. This is a very obvious perceive to be in authority. Finally, I have learned that ordinary
example of the conflict between utilitarians, who point to the citizens from wide backgrounds can, if given the chance, make
opportunity costs of treating these disorders, and egalitarians, extraordinary contributions. With knowledge and experience,
who seek a ‘fair opportunity’ for those with these miserable they can help breach the democratic deficit.
conditions. There are many other subjects about which NICE needs to
The majority of the Citizens’ Council concluded that the NHS capture the social values of society and to reflect these in the
should be prepared to pay premium prices, but they added guidance that it produces. How, for example, should we apply
conditions:18 ‘the rule of rescue’, which asserts that a physician’s first duty is

474 Clinical Medicine Vol 5 No 5 September/October 2005

 Pharmacopolitics and deliberative democracy

to rescue identifiable individuals facing avoidable death. If we References

should apply this rule, what, if any, are the limits? Furthermore,
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I’ve learned again that difficult decisions have to be made in the NHS. University, 2005.
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17 National Institute for Clinical Excellence. NICE Citizens’ Council report
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Ruth Turner, of Vision 21, was the main facilitator at the meet-
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to them both is boundless.

Clinical Medicine Vol 5 No 5 September/October 2005 475