HERA reports on stockpiling of antimicrobials

Antibiotic resistance represents a major threat for human health, as many active substances are losing efficacy towards many bacterial species.

03/05/2023

EIPG NEWS

The Health Emergency Preparedness and Response Authority (HERA) has published two final reports for the European Commission, describing respectively the results obtained during the first and second phases of the antimicrobial resistance (AMR) feasibility study on stockpiling.

Antibiotic resistance represents a major threat for human health, as many active substances are losing efficacy towards many bacterial species. The first report aims to assessing the current situation, identifying vulnerabilities and reviewing the stockpiling systems currently available in the EU. The second report discusses the vulnerabilities identified in the previous one and the potential tools and solutions to address them.

To read the report’s contents in-depth please visit the EIPG website, while here you can find a short resume of the two reports.

First report

  • 32 classes od antibiotics were identified as critical
  • 20 substances were indicated as specially relevant as first- or last-live/reserve therapies against AMR pathogens
  • 13 substances were identified as las-line/reserve therapies for severe and potentially lethal infections

For what concern stockpiling at the EU level it might not have a direct impact on the mitigation of market-driven trends; improved monitoring of potentially critical future withdrawals would be needed to enable early detection of shortages and establishment of counteractions. Innovation in the field of new antibiotics is still largely insufficient, with only six substances currently in phase 3 clinical development. The report also highlights that the analysis of supply chain vulnerabilities was “significantly limited by a lack of outside-in transparency”.

Second report

In the second report all the above-mentioned observations are deeper analyzed from different perspectives and possible approaches to the stockpiling of antibiotics are targeted. A sudden and unpredictable surge in demand and an interruption to supply are the two archetypes analyzed to better identify how to address stockpiling.

The following warning is a significant extract from the report:

stockpiling is just a short-term mechanism. It does not alter the fundamental market environment. It can only represent one part of any answer to the challenges faced by health agencies including HERA whether AMR-related or otherwise”

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