Transferable Exclusivity Extension Vouchers for Antimicrobials: Incentive Design, Implementation Challenges, and...

Antimicrobial resistance (AMR) is one of the greatest threats to public health, and forecasts for 2050 are even worse. In response, the European Commission (EC) is proposing the Transferable Exclusivity Extension Voucher (TEEV), which aims to encourage the development of innovative antimicrobials. It consists of extending data exclusivity for a medicine selected by the beneficiary company or another company to which the voucher can be sold (i.e. not necessarily the antimicrobial). One requirement for obtaining it is to declare any public contributions received for the antimicrobial R&D. Based on a review of the literature and interviews with five AMR experts, a theoretical and real view of how the TEEV works and its estimated costs is presented, in addition to the impact that the requirement for transparency in R&D costs would have. On the one hand, the results show that a (well-designed) TEEV, coordinated by the EC, offers significant public health benefits compared with the cost of inaction and provides predictability for investors, although, by its nature, it delays the entry of generics/biosimilars and does not provide an access scheme to new antimicrobials. Recent assessments estimate the total healthcare cost at €162 million per voucher and the average cost for each Member State at €6 million. On the other hand, transparency of R&D costs could enable policymakers to design policies focused on public health needs and better design the optimal mix of (push and pull) incentives for new antimicrobials, but they run the risk of threatening trade secrets, discouraging private investment and promoting the application of cost-plus pricing regulations. In conclusion, the TEEV could be a great incentive to combat AMR inaction, but it has not yet been implemented and needs to be complemented by other push and pull incentives. Furthermore, more information is needed on the impact of R&D costs transparency in the context of antimicrobials.