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?
