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Related post: has been very active in advising the National Health Service on which
procedures and which pharmaceuticals to provide (Claxton, Schulpher,
and Drummond 2002). Similarly, under the national disease management
program in Germany, IQWiG, the German equivalent of NICE, establishes
Ethics and Priority Setting in Pharmaceutical Reform Buy Amiloride 59
expert panels that develop clinical guidelines for drug use. And those
panels are explicitly instructed to take cost-effectiveness into account
(Drummond and Rutten 2008).
In the Flagship Framework, the prominent role of health status as an
ultimate goal is a re?ection of the objective utilitarian perspective. Within
pharmaceutical policy making, however, tensions have repeatedly arisen
between that view and the subjective utilitarian desire to give people what
they want. Indeed, it is not just a matter of allowing people to choose drugs
that are pleasing to them but harmless. Responding to patient demand
may actually do harm. For example, patient-driven polypharmacy (using
many different medicines at the same time) can expose patients to adverse
drug interactions. The harm can extend beyond the patient to populations,
as noted previously. Not taking a full course of antiretrovirals or antibiot-
ics and the inappropriate overuse of antimalaria drugs for nonmalarial
fevers all contribute to the development of drug-resistant infectious
agents, to the detriment of all.
When making objective utilitarianism operational, countries have to con-
sider whether to make departures from any of the widely used metrics like
QALYs or DALYs. Those indexes embody ways of valuing different outcomes
that were selected by various experts to allow for worldwide, intercountry
comparisons. For national priority setting, however, the weights or values
implicit in a particular index might not re?ect the ethics, culture, and politics
of the country concerned (Musgrove 2000).
For example, both indexes add up the number of years of life saved by
an intervention, adjusted for quality of life. This gives greater value to sav-
ing the young and healthy, rather than the old and frail, since doing the
former produces more (and higher-quality) additional life years. Such an
analysis implies that a country should give more priority to providing
inexpensive medicines that ??ght childhood diseases than to providing
expensive anticancer agents for older people. We are not saying which is
the right answer. Rather we are calling the reader�s attention to the fact
that all measures of �gain?? come with implicit value judgments. Indeed, in
practice, many nations allocate signi??cant resources to caring for those
with life-threatening illness, even when that is not cost-effective on a
DALY or QALY basis (Hadorn 1991).
National decisions about how to quantify health gains for policy pur-
poses are not just technical choices but also value choices. For a policy
maker it can be politically helpful, as a way of dealing with pressures from
diverse constituencies, to shift responsibility for a controversial priority-
setting decision to some expert body. It is not unusual for a political leader
to claim, �The numbers made me do it,?? with regard to a decision such as
60 Pharmaceutical Reform
excluding a product from a nation�s essential medicines list. However, when
the index used in the analysis was devised by some group of international
experts and was adopted without regard to local values and priorities, such
claims are an abdication of responsibility. NICE, in contrast, is at pains to
make its value assumptions explicit, and it invites public comment on this
and other aspects of its work, both before and after any actual analysis is
done (see the agency�s website at http://www.nice.org.uk).
Relating Performance Goals to Ethical
The focus of utilitarians on �the greatest good,?? based on an aggregate
measure of well-being, leads to an insensitivity about the distribution of
gains and losses within a population. In particular, strict utilitarians ??nd it
ethically acceptable to sacri??ce some for the sake of others. Also, in pur-
suit of the greatest good, objective utilitarianism can easily lead to pater-
nalism (and coercion): �We know what is best for you and will insist on
your cooperation, whether it is immunizations, motorcycle helmets, or
That lack of concern for distribution most often leads to a clash between
utilitarians and another school of ethical thought that plays a prominent role
in pharmaceutical policy making and in the Flagship Framework. That per-
spective emphasizes individual rights and is rooted in a doctrine that phi-
losophers call �liberalism.??
Like utilitarianism, liberalism is rooted in both the Enlightenment and the
Reformation. Liberalism, however, takes as its point of departure the notion
that all persons are independent and autonomous creatures, capable, at least
potentially, of making their own decisions about how to live their lives. In this
view, the role of the state is to provide a framework or context for those indi-
viduals. It is there to keep them safe, provide common services, and create a
functioning political and legal system. But how people live their lives, where
they go, and what they do these are all up to their individual choices.
If utilitarianism focuses on where everyone ends up (consequences),
liberalism focuses on where they start. Each person�s claim to freedom and
autonomy is embodied in the idea of rights. Rights are restraints against the
authority of the state and claims against fellow citizens, which together
embody a system of mutual respect. Neither I nor the government can tell
you what to do, and vice versa (as long as your actions do not affect me).
One version of liberalism, now called �libertarianism,?? is characterized by
a focus on everyone�s negative right to be left alone. Those negative rights,
Ethics and Priority Setting in Pharmaceutical Reform 61
importantly, include the protection of my property rights. Libertarianism
argues that I cannot effectively exercise my autonomy unless I am secure in
my property. (That notion was perhaps plausible in the context of an 18th-
century, heavily agricultural society.) Indeed, because taxation deprives me of
my property, libertarians argue that government activity should be kept to a
bare minimum to avoid, as much as possible, any infringement on property
rights. In many upper-income countries today, various center-right �liberal??
parties defend some version of that position.
This approach to ethics originally owed much to the Judeo-Christian
notion that God endows each human being with an immortal soul. It was the
possession of that soul that 18th- and 19th-century writers invoked to justify
the claim for universal human autonomy and respect. A famous passage from
the U.S. Declaration of Independence illustrates this line of thought:
We hold these truths to be self evident, that all men are
created equal, that they are endowed by their Creator with
certain inalienable rights, that among these rights are life,
liberty and the pursuit of happiness, that to secure these
rights, governments are established among men, deriving
their just powers from the consent of the governed.
More recently, liberals have shifted from a theological to a philosophi-
cal justi??cation. They now argue that human beings are unique in their
capacity for rational thought and planning and in their ability to recognize
moral values. That capacity entitles them to mutual respect and to the
rights that embody that respect (Scanlon 1998).
The other important development in liberal thought has been to move
beyond the focus on autonomy and mutual noninterference. Instead of an
exclusive concern with negative rights, many modern liberals also argue for
the existence of positive rights to various goods and services such as edu-
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