Biomedical Engineering Reference
In-Depth Information
contradict the main impetus of European science policies which seek to encourage
development of a knowledge based economy through research and development
and investment in patents (Atun et al. , 2007b). It is a unique feature of the life
sciences sector in Europe; thus while seeking to promote R&D in this area through
Community-supported research programmes, health policies that encourage HTA
and cost-containment discourage introduction of new innovative medicines for use
(Von der Schulenburg, 2006).
Other policies aimed at cost containment, such as therapeutic substitution and
cost sharing can adversely influence diffusion of new medicines and by reducing
the demand for necessary drugs, can lead to high levels of adverse health events
and higher overall health system costs, because savings achieved from cost-sharing
policies may be outstripped by higher outpatient use and greater hospitalisation. In
contrast, expansion of health insurance coverage leads to an increase in utilisation of
pharmaceuticals. But lack of health insurance and reduced coverage create substan-
tial barriers to the uptake and diffusion of innovative pharmaceuticals, deters use
of necessary medicines, and undermines equity. Poorer segments of the population,
namely, the elderly and the chronically ill, would disproportionately bear the brunt
of these polices.
Although disease management programmes may result in higher pharmaceutical
costs, appropriate increase in the uptake of innovative medicines leads to fewer
hospitalisations, improved quality of care, and therefore overall cost savings and
improved health outcomes.
In conclusion, there are major gaps in the evidence base needed to inform policy
on the uptake and diffusion of new medicines. Studies that explore how changes
in the regulatory environment and health system elements influence the uptake of
drugs are too narrow in scope: most of them focus on narrow efficiency measures
(such as aggregate utilisation of drugs or pharmaceutical expenditures), but fail ade-
quately to explore the impact of these changes on the uptake of innovative medicines
and innovation systems, as well as other health system objectives such as equity,
effectiveness and choice. These narrow approaches reflect a partial understanding
of the innovation process in the biopharmaceutical sector and the complexities of
translating new knowledge into new medicines.
This review confirms the need for decision makers to adopt a more holistic
approach to policy-making and regulation. The potential impact of these policies
and regulations on health system goals and objectives should be explored care-
fully. Decision makers must look beyond narrow efficiency measures in one part
of the health system (such as pharmaceutical budgets) and consider the impact
of health policies on the health system as a whole and innovation systems in the
biopharma sector.
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