Key messages

Antimicrobial and particularly antibiotic resistance is one of the biggest public health challenges the world faces. Over 1 million years of life are lost each year in the European Union (EU)/European Economic Area (EEA) alone due to antibiotic resistance, and it costs healthcare systems about €1.1 billion annually. These health and economic impacts are expected to worsen. Urgent steps are needed and this policy brief focuses on one area where the EU and its Member States can take effective action, fostering sustainable innovation and improving access to effective antibiotics.

1. Scientific, economic, structural and regulatory ‘barriers’ continue to limit the development of novel antibiotics with innovative characteristics despite intensified international efforts.

   • Only a handful of new antibiotics have been developed and launched over the last few decades, and almost none have any innovative characteristics. This means that they are vulnerable to cross-resistance with existing antibiotics.
   • Most large pharmaceutical companies have withdrawn from antibiotic research and development (R&D) because of the high risk of failure and because antibiotics are less profitable than other areas.
   • Small and medium-sized enterprises (SMEs), which now drive antibiotic R&D, face difficulty securing funding for preclinical and early clinical trials, and risk significant economic losses when launching new antibiotics.
2. Reinvigorating the antibiotic pipeline requires a holistic package of incentives.

   • Push incentives, such as direct funding and grants, can reduce the cost of R&D and have already improved the quality of the preclinical pipeline to some extent.
   • Pull incentives, such as financial rewards linked to R&D results, reimbursement reforms and regulatory changes, could increase potential revenue and create viable markets for antibiotics.
   • Aligning incentives is important and can be achieved by addressing:

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     public health factors targeting high-priority medical need, supporting antibiotic sustainability, promoting access, and protecting environmental health

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     market factors improving return on investment and supporting SMEs

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     implementation and operational feasibility considering potential political, regulatory, legislative, industry and financial hurdles.

3. Ensuring timely access to new and existing antibiotics is critical.

   • Limited access to effective antibiotics poses a risk to patients and drives the development of resistance.
   • Access to new antibiotics is often restricted because they are only launched in larger markets.
   • Access to many existing antibiotics is undermined by supply-chain problems or by their withdrawal due to low profitability.
4. Improving access to effective antibiotics requires both short- and longer-term measures.

   • Reducing regulatory administrative hurdles, engaging in good procurement practice, increasing joint purchasing efforts, and considering subscription payment models for these medicines can keep older (but effective) antibiotics on the market by ensuring their economic viability.
   • Strengthening the mapping of production capacities and product availability will improve the transparency of the antibiotic supply chain.
   • Stockpiling and strengthening manufacturing capacities within and outside of the EU can boost the supply chain itself.
5. The EU has a major role to play both in combatting antimicrobial resistance (AMR) and in contributing to global solutions.

   • The EU has a major role to play by supporting antibiotic R&D – increased and coordinated funding at the EU level can support both push and pull incentives.
   • EU engagement with other international efforts promotes optimal deployment of incentives.
   • EU commitment can help ensure that the lack of access to appropriate and effective antibiotics is recognized as a threat to global health security and a priority.
   • The EU is uniquely placed to build on its relationships with international institutions and act as a facilitator in the global space, to ensure synergies among existing structures, communicate the cost of inaction, and support national and regional initiatives.

Contents

• Foreword by Jakob Forssmed
• Foreword by Malin Grape and Josep Figueras
• Acknowledgements
• Reference group members
• Stakeholder interviewees
• Acronyms
• Executive summary
• Policy brief
  • 1. Introduction
  • 2. What are the major challenges across the R&D pathway for antibiotics?
  • 3. What challenges exist to ensure sustainable supply of new and pre-existing antibiotics?
  • 4. What actions can be taken at the EU level to stimulate research, innovation and development of new antibiotics?
  • 5. How can the EU promote sustainable and timely access to pre-existing and new antibiotics once developed and approved?
  • 6. The EU’s role in global efforts to ensure sustained access to antibiotics
• References
• Supplementary material: tables
• Supplementary material: additional policy options
• The Policy Brief Series

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