Table 1.
Summary of pull incentives for antibiotic research and development implemented in Europe.
| Country | Name | Timeline | Mechanism type | Antibiotics targeted |
|---|---|---|---|---|
| France | Exception for antibiotics with ASMR level IV (minor), and those assessed by non-inferiority clinical trials | In effect since 2015 | Medicines with’ moderate’ or higher added therapeutic benefit are guaranteed a price not lower than the lowest price across 4 reference countries. In 2015, this is extended to antibiotics with ‘minor’ added therapeutic benefit. In 2021, this is extended to antibiotics assessed by non-inferiority clinical trials | Antibiotics assessed as being ASMR level IV (minor), including those assessed by clinical non-inferiority trials |
| Germany | Changes in pharmaceutical legislation | In effect since 2017 | Ad hoc exception of antimicrobials from internal price reference groups | Decided by reimbursement authority ad hoc taking into consideration resistance patterns |
| Health Insurance Law | In effect since 2020 | Automatic exception of ‘reserve’ antibiotics from internal price reference groups, accelerated reimbursement review process following EMA approval | ‘Reserve’ antibioticsa | |
| Sweden | Annual revenue guarantee | In effect since 2020 | PHAS sets a minimum guaranteed annual revenue for selected originator antibiotics in exchange for a guaranteed supply volume. Payments are priced to secure access rather than incentivise research and development. | “Critical” pathogens in the WHO Priority Pathogens List |
| UK | Innovative models for the evaluation and purchase of antimicrobials | In effect since 2022 | Annual fee, negotiated based on AMR-specific HTA, delinked from volume supplied | Pathogens on the WHO Priority Pathogens |
Source: Adapted with permission from Gotham et al., 2021.50
AMR – antimicrobial resistance. ASMR – amélioration du service médical rendu (added therapeutic benefit). DRG – diagnosis-related group. EMA – European Medicines Agency. HTA – health technology assessment. PHAS – Public Health Agency of Sweden. PPL – priority pathogens list. QIDP – qualified infectious disease product. TLV – Tandvårds-och läkemedelsförmånsverket (Swedish Dental and Pharmaceutical Benefits Agency). a‘Reserve group’ is to be defined by the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices. There is also a separate definition of “reserve” antibiotics used by the WHO AWaRe (Access, Watch, Reserve) programme.