HERA commissioned feasibility study on stockpiling of antimicrobials against AMR published

HERA commissioned an AMR feasibility study on stockpiling, initiated as preparatory actions under the HERA incubator, and covering two key priority areas of HERA: the threat of antimicrobial resistance (AMR) and stockpiling efforts for medical countermeasures.

The study covers and elaborates on:

• Identification of antimicrobials with critical need for undisrupted access
• Analysis of supply chain vulnerabilities for the selected antimicrobials
• Review of existing antimicrobial stockpiling systems at EU and global level
• Identification and assessment of options for stockpiling of antimicrobials at EU level (physical vs virtual alternatives)

The study has been carried out in two phases, each delivering a specific report.

The first phase (report accessible) comprises a mapping and assessment of the most needed antibiotic products, identifying their vulnerabilities and other relevant stockpiling systems within and outside the EU.

The second phase (report accessible) comprises an analysis of the vulnerabilities identified and the potential means of overcoming them.

Summary of main results

The study identified 32 classes of antibiotics for which continued access might be required by EU Member States to keep available on a continuous basis sufficient therapeutic and prophylactic options for patients with systemic bacterial infections.

The analysis identified common structural vulnerabilities across all 32 critical classes of antibiotics, including limited EU self-sufficiency for the production of APIs and the absence of buffer manufacturing capacity for critical intermediates (e.g., 6-APA for penicillins or 7-ACA for cephalosporins).

According to the contractor, the Commission could consider implementing several options, including a mandated increase of inventories within existing commercial supply chains and/or a virtual stockpiling mechanism.

Next steps

The results of this study will be used for the following initiatives:

• The contractor’s proposals for improving antimicrobial supply chain continuity that require legal basis to be implemented, notably the establishment of mandated increase of inventories within existing commercial supply chains, have been submitted to the Commission service in charge of revision of the EU Pharma legislation (DG SANTE) for further assessment and potential inclusion in the revised act.
• The contractor’s proposals of establishing a physical EU-owned stockpile of anti-TB drugs is currently being assessed by the Commission services in charge of preparing the upcoming call for proposals on stockpiling medical countermeasures under the EU funding programme “RescEU”.
• Finally the methodology developed for the prioritization of antimicrobials for stockpiling, and the assessment of supply chain vulnerabilities is being used for the building of HERA’s own capacity for intelligence gathering on MCM.