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Transferable exclusivity voucher: a flawed incentive to stimulate antibiotic innovation

Årdal C, Baraldi E, Busse R, Castro R, Ciabuschi F, Cisneros JM, Gyssens IC, Harbarth S, Kostyanev T, Lacotte Y, Magrini N, McDonnell A, Monnier AA, Moon S, Mossialos E, Peñalva G, Ploy MC, Radulović M, Ruiz AA, Røttingen JA, Sharland M, Tacconelli E, Theuretzbacher U, Vogler S, Sönksen UW, Åkerfeldt K, Cars O, O'Neill J.

As antibiotic resistance increases globally, antibiotic innovation is struggling. WHO states that the antibiotic clinical pipeline is “insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance”. To prevent the development of resistance, new antibiotics are used as last resort treatments and, if properly used, have small patient populations, resulting in fairly low sales revenues for industry.

Several incentives have been proposed to stimulate antibiotic innovation. The pharmaceutical industry champions the transferable exclusivity voucher for European implementation. The voucher is a complex, untested incentive. In theory, a developer would be awarded a voucher with the regulatory approval of an important new antibiotic. This voucher could then be applied to one non-related medicine (eg, a cancer immunotherapy), extending its patent period up to 1 year. If the antibiotic developer does not want to use the voucher, the company could sell it. This indirect transaction is expected to generate a lucrative one-time payment for the antibiotic innovator.

The European Commission (EC) is expected to include the voucher in its proposed revision of the pharmaceutical legislation, expected in March, 2023. This decision would be unfortunate since there are fundamental problems with the transferable exclusivity voucher.

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