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EU Mulls Paying for Late-Stage Neglected Disease Drug Research

• The EU's Health Emergency Preparedness and Response Authority (HERA) is considering pull incentives to bolster neglected disease drug development. • HERA may fund late-stage research needed for marketing authorization, aiming to align developer interests with public health needs. • Advance market commitments and demand estimations are also under consideration to improve market viability for these products. • A €20m loan was granted to Fabentech to develop a technology platform against deadly viruses and toxins under the HERA Invest initiative.

The EU’s Health Emergency Preparedness and Response Authority (HERA) is exploring pull incentives, including funding late-stage drug research, to stimulate the development of treatments for neglected diseases. This initiative aims to make the market more attractive for companies to invest in developing countermeasures.

Addressing Market Failures in Neglected Diseases

Maria Daniel Loureiro, an intelligence analyst at HERA, highlighted the need to shift focus towards pull incentives that support later-stage development and bring products to market. Speaking at the European Health Forum Gastein (EHFG) meeting in Austria, she noted that current emphasis on push incentives, such as grants and funding for early-stage research, is insufficient.
HERA is considering directly funding the late-stage research necessary to support a marketing authorization application. Loureiro cited HERA’s recent €22m ($24m) funding to Biofabri’s MTBVA vaccine as an alternative to BCG vaccination in infants and for preventing TB in adolescents and adults as an example. "We were paying for the clinical and non-clinical research that needs to go into the building of the portfolio that is submitted to EMA for market access," she said.

Potential Pull Incentives

In addition to direct funding, HERA is also considering advance market commitments to guarantee immediate access to supported innovations. Developing demand estimations to gauge the need for certain products across member states is another possibility, helping companies assess market viability.
Another pull incentive discussed was the potential for an EU version of the US FDA’s priority review vouchers.

HERA Invest Initiative

Separately, the first loan under the HERA Invest initiative was announced, providing €20m to Fabentech, a French company, to develop a technology platform designed to neutralize deadly viruses and toxins. This push initiative targets small and medium-sized companies, encouraging them to invest in R&D for priority health threats based in the EU.
HERA was established after the COVID-19 pandemic, focusing on pandemic pathogens, CBRN threats, and antimicrobial resistance, which includes some neglected diseases.
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Reference News

[1]
EU Authority Mulls Paying For Late-Stage Research As A Pull Incentive For Neglected ... - Pink Sheet
pink.citeline.com · Oct 11, 2024

HERA is considering pull incentives for neglected diseases, including advance market commitments and paying for late-sta...

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