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SAHR 2007 - Health Systems Trust

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and financial value of competing services, plus estimate the<br />

potential budgetary impact relating to specific interventions<br />

This approach has potential advantages. The health care<br />

system which lacks normal market dynamics that tend<br />

to control prices of goods takes on the role of informed,<br />

discerning purchaser of health care. This pressurises pharmaceutical<br />

and technology companies to price their products<br />

appropriately. The rationale for inclusion and exclusion<br />

of care within a national health package is in the public<br />

domain and can be debated.<br />

However, this type of approach is also fraught with problems<br />

and complexities. Although drug and technology<br />

appraisals are guided by scientific and economic rationale,<br />

final decisions are not immune to external political, media<br />

and emotional hyperbole. Pressures experienced by those<br />

tasked with decision making at a national level in relation to<br />

funding of health care can prove immense.<br />

Not only is comprehensive adjudication of medicines and<br />

technologies a lengthy process that is prone to derailment,<br />

(especially where patient lives are claimed to be threatened<br />

as a result of the delay) but there is no technical formula on<br />

which an emphatic recommendation can be based. Instead,<br />

decisions ultimately rely on value judgements. Such value<br />

judgements are based on confidence in the scientific and<br />

economic data submitted, magnitude of proposed clinical<br />

benefits, gravity of condition to be treated, financial calculations<br />

such as incremental cost-effectiveness, as well as social<br />

values reflected in the institutional framework of decision<br />

making. 10,11 For example, German authorities have cautioned<br />

against the use of cost-utility analyses, for the reason that<br />

studies have shown that distribution of resources on the<br />

basis of aggregated quality-adjusted life years (QALYs) is not<br />

accepted by the population as it does not reduce inequality<br />

and it discriminates against the elderly, disabled and chronically<br />

ill. As such, it is contrary to the country’s social values<br />

that support equity of accessibility and allocation.<br />

Restrictions imposed on the public distribution of ‘commercial-in-confidence’<br />

data can also act as an impediment to<br />

national health authorities in successfully defending negative<br />

decisions and countering political and emotive pressures.<br />

national health agencies. In Australia, the PBS became a<br />

key factor in free trade negotiations between the USA and<br />

Australia. 12<br />

Unless approval of new expensive interventions is supported<br />

by appropriate funding or associated with formal exclusion<br />

of existing services, there is likely to be a negative impact<br />

on overall service delivery as highlighted by doctors in<br />

the National <strong>Health</strong> System (NHS) recently. In the NHS, the<br />

Primary Care <strong>Trust</strong>s (PCTs) act as the principal fund holder<br />

that commissions health care from hospitals, general practitioners<br />

(GPs) and other health care providers. Once they<br />

have received their budgets (calculated on the basis of a<br />

population-based formula) they must ensure that they do<br />

not show a deficit at the end of each financial year. Given<br />

this, positive NICE guidance which has been legally-binding<br />

in both England and Wales since January 2005, is proving<br />

problematic. Following the approval of Herceptin for early<br />

breast cancer, the Norfolk and Norwich University Hospital<br />

NHS <strong>Trust</strong> estimated that such guidance would cost their fund<br />

£1.9 million per annum in drug costs alone and to balance<br />

the books other treatment would have to be dropped,<br />

leading to haphazard withdrawal of care. 13 As such, NICE<br />

is not achieving its objective of defusing the so-called postcode<br />

lottery system of health care in England and Wales,<br />

where availability of care is claimed to depend on the NHS<br />

<strong>Trust</strong> area in which a patient lives. This has prompted the<br />

British Medical Association (BMA) to call for a basic basket<br />

of NHS services that all patients within the NHS would be<br />

entitled to. 14<br />

Review of relevant policy and<br />

legislation<br />

For the South African government to achieve its objective<br />

of equitable access to health care, legislative reform in the<br />

private sector has focused on three areas:<br />

1. medical scheme reform to facilitate a system of social<br />

health insurance;<br />

2. transparency in and reduction of medicine prices; and<br />

3. licensing of health care technology.<br />

Given the size of the pharmaceutical and health technology<br />

sectors, they have an impact on a country’s economic wellbeing<br />

and as a result a country’s interests relating to trade<br />

and industry may come into conflict with its intentions of<br />

providing universal health care coverage. This may provide<br />

a platform on which powerful companies aim to undermine<br />

126

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