Davies, J.E., Neidle, S. and Taylor, D.G. (2012) Developing and paying for medicines for orphan indications in oncology: utilitarian regulation vs equitable care? British Journal of Cancer, 106 (1). pp. 14-17. 10.1038/bjc.2011.544.
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Despite orphan drug legislation, bringing new medicines for rare diseases to market and securing funding for their provision is sometimes both costly and problematic, even in the case of medicines for very rare ultra orphan oncological indications. In this paper difficulties surrounding the introduction of a new treatment for osteosarcoma exemplify the challenges that innovators can face. The implications of current policy debate on value-based medicines pricing in Europe, North America and elsewhere are also explored in the context of sustaining research into and facilitating cancer patient access to medicines for low-prevalence indications. Tensions exist between utilitarian strategies aimed at optimising the welfare of the majority in the society and minority-interest-focused approaches to equitable care provision. Current regulatory and pricing strategies should be revisited with the objective of facilitating fair and timely drug supply to patients without sacrificing safety or overall affordability. Failures effectively to tackle the problems considered here could undermine public interests in developing better therapies for cancer patients
|Uncontrolled Keywords:||Mifamurtide; orphan drugs; regulatory strategy; value-based pricing|
|Departments, units and centres:||Department of Pharmaceutical and Biological Chemistry > Department of Pharmaceutical and Biological Chemistry|
|Journal or Publication Title:||British Journal of Cancer|
|Deposited By:||Library Staff|
|Deposited On:||09 Feb 2012 12:57|
|Last Modified:||09 Feb 2012 12:57|
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