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HomeA study assessing scientific, engineering, legal and economic considerations of flexible EU manufacturing and innovation of medical countermeasures for serious cross-border threats to health
Final report
A study assessing scientific, engineering, legal and economic considerations of flexible EU manufacturing and innovation of medical countermeasures for serious cross-border threats to health
Final report
Publication metadata
HERA seeks to address what role flexible, multi-technology EU manufacturing and process innovation capacity can play to facilitate surge manufacturing capacity and improve the EU’s access to both vaccines and therapeutics. The report explores the role of manufacturing flexibility in creating manufacturing capacities, evaluating the scientific, engineering, legal and economic aspects, and compares the potential implementation options, including public-private partnerships, capacity reservation contracts, and advance purchase agreements (APAs). Responding to the complex threat landscape of serious cross-border threats to health requires strengthening the EU’s preparedness and response. The report recommends direct capacity reservation agreements with EU-based manufacturers as the most suitable option for HERA, and specifically reservation of flexible product-agnostic manufacturing capacities for key technology platforms in both vaccines and therapeutics, partnering with two manufacturers for each platform where this can be economically done to ensure dual sourcing that mitigates supplier risks. Additional supplementary conclusions include taking action to reinforce supply chain resilience associated with the flexible manufacturing capacity, supporting regulatory and quality requirements, and supporting mechanisms to drive innovation in both novel products and manufacturing technologies. Finally, the report recommends a coordinated approach considering the ongoing and planned initiatives of EU Member States in this space.
- Published:
- Corporate author(s): European Health and Digital Executive Agency (European Commission) , McKinsey & Company
- Themes: Public health
- Subject: coronavirus disease , crisis management , cross-border cooperation , epidemic , innovation , market approval , medical device , medicinal product , pharmaceutical industry , public health , report , vaccination , vaccine
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| ISSN | ISBN 978-92-95224-39-1 | DOI 10.2925/4641 | Catalogue number HW-08-23-060-EN-N |
- Released on EU Publications:
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