Rosa Castro
Senior Policy Manager, European Public Health Alliance (EPHA)
In 2019, 4.95 million deaths were associated and 1.27 million were directly attributable to bacterial antimicrobial resistance (AMR).
While the development of new effective antibiotics is crucial to respond to raising levels of AMR, the market for new antibiotics is broken. On top of scientific difficulties, current market-based incentives have largely failed to make antibiotics an attractive market.
Incentivising antibiotics
It is not surprising that the European Union is planning to address this. Its recently created Health Emergency and Response Authority (HERA) is looking at ways to incentivise new antibiotics. New incentives are likely to be included in the upcoming revision of the general EU pharmaceutical legislation.
With so much at stake, it is worrying to see that the EU Commission has focused on a very narrow range of alternatives for possible inclusion in the pharmaceutical legislation. Only the adoption of a ‘play or pay’ model or the creation of a transferable exclusivity extension have been superficially discussed during consultations with stakeholders.
The high, unpredictable costs directly threaten the sustainability of EU healthcare systems.
Costly model
The ‘play or pay’ model creates an obligation for pharmaceutical companies to either invest in AMR-related innovation or to pay a fee to a fund that would then be used to spur the development of new antibiotics.
An exchangeable voucher works by creating an attractive market for new antibiotics. The voucher would be granted to the company that develops a new antibiotic; and because the voucher will be exchangeable, the recipient company can sell the voucher to any other company. The buyer (very likely a bigger company) can use it to extend the exclusivity period of any other medicinal product in their portfolio.
As it does not require upfront payments, the exchangeable voucher can entice EU policymakers. Yet, every independent study has found that this option will be costly and ineffective.1 The high, unpredictable costs directly threaten the sustainability of EU healthcare systems.
Expanding options
Alternatives, including a revenue guarantee described by experts engaged in an EU-funded project,2 should be better examined. AMR and the scarcity of new antibiotics and complex global threats are calling for a robust assessment of policy alternatives.
The antibiotic market failure should be addressed by a consistent plan integrating prevention as well as EU pull and push incentives, in cooperation with other countries. The creation of a transferable voucher at the EU-level risks worsening access to antibiotics and other medicines in the EU and globally.
[1] https://epha.org/wp-content/uploads/2022/07/antibiotic-incentives-pharma-legislation-joint-paper-2022.pdf
[2] https://globalamrhub.org/wp-content/uploads/2021/08/antibiotics-10-00749.pdf