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Challenges and opportunities for incentivising antibiotic research and development in Europe

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 c...

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Autores principales: Anderson, Michael, Panteli, Dimitra, van Kessel, Robin, Ljungqvist, Gunnar, Colombo, Francesca, Mossialos, Elias
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10403717/
https://www.ncbi.nlm.nih.gov/pubmed/37546576
http://dx.doi.org/10.1016/j.lanepe.2023.100705
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author Anderson, Michael
Panteli, Dimitra
van Kessel, Robin
Ljungqvist, Gunnar
Colombo, Francesca
Mossialos, Elias
author_facet Anderson, Michael
Panteli, Dimitra
van Kessel, Robin
Ljungqvist, Gunnar
Colombo, Francesca
Mossialos, Elias
author_sort Anderson, Michael
collection PubMed
description 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.
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spelling pubmed-104037172023-08-06 Challenges and opportunities for incentivising antibiotic research and development in Europe Anderson, Michael Panteli, Dimitra van Kessel, Robin Ljungqvist, Gunnar Colombo, Francesca Mossialos, Elias Lancet Reg Health Eur Health Policy 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. Elsevier 2023-07-26 /pmc/articles/PMC10403717/ /pubmed/37546576 http://dx.doi.org/10.1016/j.lanepe.2023.100705 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Health Policy
Anderson, Michael
Panteli, Dimitra
van Kessel, Robin
Ljungqvist, Gunnar
Colombo, Francesca
Mossialos, Elias
Challenges and opportunities for incentivising antibiotic research and development in Europe
title Challenges and opportunities for incentivising antibiotic research and development in Europe
title_full Challenges and opportunities for incentivising antibiotic research and development in Europe
title_fullStr Challenges and opportunities for incentivising antibiotic research and development in Europe
title_full_unstemmed Challenges and opportunities for incentivising antibiotic research and development in Europe
title_short Challenges and opportunities for incentivising antibiotic research and development in Europe
title_sort challenges and opportunities for incentivising antibiotic research and development in europe
topic Health Policy
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10403717/
https://www.ncbi.nlm.nih.gov/pubmed/37546576
http://dx.doi.org/10.1016/j.lanepe.2023.100705
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