TY - JOUR
T1 - Challenges and opportunities for incentivising antibiotic research and development in Europe
AU - Anderson, Michael
AU - Panteli, Dimitra
AU - van Kessel, Robin
AU - Ljungqvist, Gunnar
AU - Colombo, Francesca
AU - Mossialos, Elias
N1 - Funding Information:
While the policy discussion at the EU level is predominantly focused on pull incentives, 10 it is vital to emphasise the continued need for push incentives to encourage antibiotic research and development for drug discovery science, preclinical, and early clinical research. This was also recently acknowledged as a priority within the recently published Council of the European Union recommendations on AMR. 9 This is important because the high failure rate in earlier development stages means that the drug discovery and preclinical pipeline will not be sustainable without some form of public funding or subsidisation. There are strong economic arguments for public subsidisation in this therapeutic area, as having a supply of effective antibiotics and reduced infection can be considered a “public good” that benefits society holistically. 91 With this in mind, the EU needs to consider balancing push and pull incentives together to improve the quality of the antibiotic pipeline. Completing the ND4BB programme (including ENABLE and TRANSLOCATION programmes focused on drug discovery) means an unmet need for continued push incentive funding by the EU focused on drug discovery and preclinical research. While ENABLE has continued within the ENABLE-2 programme, this was launched using limited funding from the Swedish government and operates on a much smaller scale. 92 The establishment of the Innovative Health Initiative (IHI) (a budget of €2.4 billion between 2021 and 27), 31 and the Health Emergency Response Authority (HERA) (with a budget of approximately €6 billion for the years 2021–2027) represent significant opportunities to reinvest in push incentives, 7 although their investment properties are yet to be defined.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/10/1
Y1 - 2023/10/1
N2 - Antimicrobial, and particularly antibiotic resistance are one of the world's biggest challenges today, and urgent action is needed to reinvigorate the antibiotic development pipeline. To inform policy discussions during and after the 2023 Swedish Presidency of the Council of the European Union, we critically appraise incentive options recently proposed by the European Commission, and member states, and consider what has been achieved over the last two decades in relation to antibiotic research and development. While several new antibiotics have achieved regulatory approval in recent years, almost none have innovative characteristics such as new chemical classes or novel mechanisms of action. We consider four incentive options to incentivise research and development of new antibiotics, including subscription payments, market entry rewards, transferable exclusivity extensions, and milestone payments. While each option has advantages and drawbacks, a combination of incentives may be required and continued investment is needed by the EU in push incentives, such as direct funding and grants, to incentivise drug discovery and preclinical stages of development. The EU must also coordinate with international initiatives and support access to new and pre-existing antibiotics in LMICs through platforms such as the WHO, and G7 and G20 group of countries.
AB - Antimicrobial, and particularly antibiotic resistance are one of the world's biggest challenges today, and urgent action is needed to reinvigorate the antibiotic development pipeline. To inform policy discussions during and after the 2023 Swedish Presidency of the Council of the European Union, we critically appraise incentive options recently proposed by the European Commission, and member states, and consider what has been achieved over the last two decades in relation to antibiotic research and development. While several new antibiotics have achieved regulatory approval in recent years, almost none have innovative characteristics such as new chemical classes or novel mechanisms of action. We consider four incentive options to incentivise research and development of new antibiotics, including subscription payments, market entry rewards, transferable exclusivity extensions, and milestone payments. While each option has advantages and drawbacks, a combination of incentives may be required and continued investment is needed by the EU in push incentives, such as direct funding and grants, to incentivise drug discovery and preclinical stages of development. The EU must also coordinate with international initiatives and support access to new and pre-existing antibiotics in LMICs through platforms such as the WHO, and G7 and G20 group of countries.
KW - Antibiotic resistance
KW - Antimicrobial resistance
KW - Drug development
U2 - 10.1016/j.lanepe.2023.100705
DO - 10.1016/j.lanepe.2023.100705
M3 - (Systematic) Review article
C2 - 37546576
SN - 2666-7762
VL - 33
JO - The Lancet Regional Health – Europe
JF - The Lancet Regional Health – Europe
IS - 1
M1 - 100705
ER -