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The commercial model2018-03-09T07:12:19+00:00

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  • David BrownDavid Brown
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    The commercial model for antibiotics is broken and that is hindering investment in antibiotic R&D. The situation was similar in rare diseases with low patient populations but his has been fixed in both USA and Europe by various actions such as the following:

    1. Regulatory advantages – Orphan Drug Act and Orphan Designation
    2. Market exclusivity (7-10 years)
    3. Protected pricing
    4. Fast-track vouchers from FDA / EMA
    5. Tax breaks (50%) and Fee waivers

    So why not simply copy those for bacterial diseases? Could this be done by defining each one of the ESKAPE (etc) pathogens as a separate rare disease?

    Are any authorities looking into this option?

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