Presentation (CTI)

OBJECTIVES: 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 desired by the beneficiary company or another company to which the voucher can be sold. One requirement for obtaining it is to declare any public contributions received for R&D.
METHODS: Based on a review of the literature and interviews with five AMR experts, a theoretical and real view of how the TEEV works is studied, in addition to its estimated costs and the impact that the requirement for transparency in R&D costs would have.
RESULTS: The results show that the TEEV, coordinated by the EC, aims to motivate Member States (MS) and other regions to implement their own mechanisms for accessing and financing innovative antimicrobials. It offers significant public health benefits compared to the cost of inaction and provides predictability for investors, although, by its nature, delays the entry of generics/biosimilars and is unable to ensure access to new antimicrobials. Recent assessments estimate the total healthcare cost at €162 million per voucher and the average cost for each MS is €6 million. Finally, transparency of R&D costs could enable policymakers to design policies focused on public health needs, but they run the risk of threatening trade secrets and discouraging private investment.
CONCLUSIONS: In conclusion, this is a great incentive to combat AMR inaction, but it has not yet been implemented and needs to be complemented by other push incentives. Furthermore, more information is needed on the impact of R&D costs transparency in the context of antimicrobials.