Transferable Exclusivity Vouchers: A Silver Bullet?

OBJECTIVES: The European Union (EU) has proposed a new Regulation to replace Regulation 2004/726, introducing the concept of a transferable data exclusivity voucher (TEV) as an incentive for the development of priority antimicrobials. Antimicrobial resistance is a significant issue in the EU, leading to deaths and substantial healthcare costs, but pharmaceutical companies have been hesitant to invest in antimicrobial development due to limited market prospects.

METHODS: The EU aims to encourage the development of priority antimicrobials by offering a transferable data exclusivity voucher. We seek to summarise the pros and cons of this approach and draw conclusions on whether it is likely to be successful.

RESULTS: TEVs may well incentivise innovation in this field. However, they also may lead to higher drug prices. Furthermore, they do not guarantee access to antimicrobials, and they may draw focus away from preventative measures, harming ongoing antimicrobial stewardship outcomes.

CONCLUSIONS: The transferable data exclusivity voucher is intended to incentivize the development of priority antimicrobials and address antimicrobial resistance. Its forthcoming implementation has generated mixed opinions. Critics argue that it may indirectly burden member states with higher drug prices and exacerbate the limited access to innovative drugs in some markets However, the research-based pharmaceutical industry in Europe has generally supported the concept. The voucher has the potential to generate significant revenues for sellers, and it could serve as an initial step toward combating antimicrobial resistance in the future.