The Creation of New Orphan Patient Groups

In cases where either no effective therapy is available or existing therapy is inadequate, major ethical problems are raised if new drugs will only be developed either for the most common genotypes or for groups identified as good responders. In both cases, new products might not be developed for patients with the "wrong genotype" or for genomic groups that are too small in size to attract investment from the industry. This would create new therapeutic "orphan populations" that are economically unattractive to the pharmaceutical industry and have no access to new and more effective therapy (15,17). This problem might be exacerbated in the case of poor populations (as in developing countries) or in minority groups, who already have serious problems getting access to health care. Significant public sector investment in research, increased drug pricing, and new policies, similar to existing orphan drug legislation in the US and Europe might be required to provide the resources and financial incentives to encourage the private sectors to invest in these areas (18,27).

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