Pharmacy Law and Ethics Association
No such thing as fair shares in the NHS
Not a day passes without news reports of the constraints of a cash-limited
NHS, with headlines like: “Paying for the cancer drug Herceptin
means other cancer patients will lose out, doctors warn”; “NICE
denies access to Aricept for early stage Alzheimer’s”; and “Do
smokers and heavy drinkers have the right to scarce health care resources?”.
To
what extent does the law set boundaries between the rights of the individual
and the wider interests of local and national populations?
On the ground, how do health care professionals, including prescribing
adviser pharmacists, square their ethical obligations to individual patients
with their mandate to stay within budgets or meet government priority
targets?
Christopher Newdick, Professor in Health Law at the University of Reading,
spoke about rationing, the law and government policy. When it came into
office in 1997, the New Labour government committed itself anew to the
historic principle of the NHS of providing for everyone whatever treatment
was required, based on need and need alone. But it soon became clear
that, like its predecessors, the administration was making claims that
could not be met from the resources available, Professor Newdick said.
The
NHS was represented as a comprehensive service that met all the public’s
needs but patently did not do so, and NHS clinical and managerial staff
were caught between the growing disillusion of the public and the tendency
of governments to point to them as scapegoats for a failing service.
Under the NHS Act, the Secretary of State for Health has a statutory
duty to promote (but not necessarily provide) a comprehensive health
service. And it has been established through case law that rationing
of health services is lawful because a comprehensive service, for resource
reasons, may never be achievable.
The Secretary of State delegates his NHS functions to primary care trusts
and health boards in England and Wales, and the NHS Acts require them
to carry these out within their budgets. The Government established the
National Institute for Health and Clinical Excellence with the aim of
reducing inequities in access to expensive new treatments, by making
expert assessments and issuing technical assistance guidance (TAGs) on
whether treatments can be recommended for routine use in the NHS. TAGs
must be implemented by local trusts within three months of issue.
However,
several court cases have established that PCTs have reasonable discretion
in the allocation and weighting of priorities. For example, an authority
may decide that treatment of cancer or heart disease merits higher
priority than treatment for transsexualism, and different PCTs may have
different
priorities. However, blanket bans are unreasonable and exceptions to
policy might have to be made.
A rationing case study
In November 2005, North Stoke Primary Care
Trust decided not to fund Herceptin (trastuzumab) which, at that
time, was not licensed
for
the early treatment of breast cancer, for a patient with that
indication. Following negative publicity, the PCT reversed its
decision.
In
April 2006, Swindon PCT’s decision not to fund the drug
was overturned in the Court of Appeal. In May 2006, Herceptin
was licensed
for use in early breast cancer and, in August, NICE issued guidance
on supplying the drug. The cost of treatment is £20,000
per patient per annum (by comparison, treatment for chronic heart
failure
is £300 per patient per year).
The case attracted much
media interest and it was suggested that the initial decision
to supply
resulted from government pressure, overriding its own policy,
on the PCT because of the critical media coverage. |
Practical pointers for making difficult resource allocation decisions
Rationing brings ethical dilemmas. It is broadly recognised that health
need is greater than the available resources and, despite increased investment,
not all need can be met, said Julian Sheather, senior ethics adviser
at the British Medical Association. There is, therefore, a requirement
to find morally acceptable methods of distributing these scarce resources,
but it must first be acknowledged that where resources are scarce some
legitimate need will not be met, he added.
The dilemma lies in choosing whose needs will be prioritised. There are
several possible approaches:
• Absolute equality, where an equal amount is given to all
• A rights based approach, founded on a morally justifiable respect for
people’s rights
• A distribution in proportion to need (ie, the greater the need the
greater the resources provided) based on morally relevant differences
This last approach is intuitively attractive, particularly among health
professionals, but its obverse is the concept of “just desserts”,
which contends that, for example, a heavy smoker’s health problems
may be self-inflicted and, therefore, less deserving of the allocation
of scarce resources.
The meaning of needs and the hierarchies within them — survival,
growth, fulfilment — must also be taken into account, Dr Sheather
said. However, there is no universal measure by which needs can be evaluated
and compared. For example, how can hip replacements be compared with
cancer treatment or gender realignment surgery? They are, in reality,
incommensurables that cannot be compared but, in the allocation of NHS
resources, they have to be.
One method used for weighting incommensurables is quality adjusted life
years (QALYs), which compares the cost of interventions for different
conditions against the improvement in quality and additional length of
life they provide. QALYs are a measure of benefit and, rather than assessing
allocation of scarce resources in terms of meeting need, it might be
morally preferable to allocate resources to provide the greatest benefit
to the greatest number.
In practice, the competing forces of needs and benefits have to be weighed
up. In the situation of two patients with the same high need but with
one having a higher probability of benefit, should preference for treatment
be given to the latter if there is not sufficient resource for both?
Also, can a need be distinguished from a want, Dr Sheather asked. For
example, should everyone thinking that they need cosmetic surgery or
infertility treatment be told to pay for it themselves?
There are some practical pointers to help guide health care professionals
who have to make difficult resource allocation decisions. Giving thought
to efficiency and avoiding waste will maximise the benefit that can be
provided, as will use of treatments for which there is evidence of efficacy,
and ensuring that the least expensive of comparable options is chosen.
The moral values that should be engaged include: responding to need in
proportion to it; distributing benefit as widely as possible; providing
maximum choice; and respecting people’s autonomy.
In making these morally difficult decisions transparency is essential:
decision makers should be explicit about how decisions are made, who
makes them and what balancing methods are used. Decisions should be accountable
to democratic process and should be open to public scrutiny, Dr Sheather
concluded. |
The
Pharmaceutical Journal