Prior Information Notice on speeding up the development of and access to innovative medical countermeasures

HaDEA has published a Prior Information Notice (PIN) for a call for tenders to be funded under the EU4Health 2023 Annual Work Programme.

Interested parties are invited to consult TED and eTendering for the possible publication of the contract notice and tender documents.

HADEA/2023/OP/0036 – PIN “Speed up the development of and access to innovative medical countermeasures”

The objective of this call is to conclude service contracts for the purchasing of clinical and non-clinical services to speed up availability and access to innovative medical countermeasures (MCMs) to diagnose/detect, prevent, protect from or treat conditions associated to serious cross-border health threats.

In particular: 

Lot 1 will support the assessment of the vaccine candidate’s efficacy and safety (within Phase II clinical trials), as well as any development that helps identify the most promising preparation, dose, and schedule to be tested in Phase III clinical trials, related to antimicrobial resistance.

Lot 2 will support the assessment of the candidate’s efficacy and safety (within Phase II clinical trials) to foster the development of broad-spectrum antivirals targeting respiratory RNA viral families, mainly, but not limited to, Paramyxo-, Orthomyxo- and Coronaviridae, as well as any development that helps identifying the most promising preparation, dose, and schedule, to be tested in Phase III clinical trials.

Lot 3 will support the assessment of the candidate’s efficacy and safety (within Phase II clinical trials) to foster the development of broad-spectrum antivirals targeting RNA viral families known for causing viral hemorrhagic fever (mainly, but not limited to, Arena-, Bunya-, Flavi- and Filoviridae), as well as any development that helps identifying the most promising preparation, dose, and schedule, to be tested in Phase III clinical trials.

Lot 4 will support the development and certification of a metagenomic next-generation sequencing (mNGS)-based device for point-of-care infectious disease diagnostics and early outbreak detection. The device will be able to detect any respiratory viral pathogen, including novel and emerging, delivering a result readable to clinicians within hours while being cost-competitive with current molecular diagnostics.

Estimated budget: €82 000 000

Background

EU4Health, with a budget of €5.3 billion, is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe.

HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and tenders from 2021 to 2027.