EU Authority Mulls Paying For Late-Stage Research As A Pull Incentive For Neglected Disease Drugs

The EU’s Health Emergency Preparedness and Response Authority (HERA) is considering a range of pull incentives for neglected diseases, including advance market commitments and paying for the late-stage drug research needed to support a marketing authorization application, according to Maria Daniel Loureiro, an intelligence analyst, at HERA.

The goal is to make development of such products more attractive by improving market conditions, she said at the European Health Forum Gastein (EHFG) meeting, which took place in Austria on 25 September.

Push incentives are designed to incentivize R&D by reducing research costs, for example through grants, funding or tax credits. Meanwhile, pull incentives aim to make R&D more attractive by reducing financial risk and making the product market more viable.

Pull And Push

The COVID-19 pandemic and the monkeypox crisis were “important learning experiences for EU officials,” Loureiro said. Not only did they show how a local threat can turn into a global cross-border threat, they demonstrated the “importance of maintaining a strong portfolio of available medical countermeasures … for a broad spectrum of conditions that can cause a public health threat.”

However, there is currently too much emphasis on push incentives that can fund early-stage research, but which do little to support later stage development and actually bring products onto the market, agreed several speakers at the event.

Loureiro believes that the EU has a role in remedying this to align the interests of developers with public health needs. She commented that HERA is considering a number of pull incentives to “guarantee EU competitiveness and market interest for development.”

One such possibility is for HERA to pay for the late-stage drug research necessary to support a marketing authorization application. She pointed to HERA’s recent €22m ($24m) funding to accelerate final stage development a non-neglected disease product. This is Biofabri’s MTBVA vaccine as an alternative to BCG vaccination in infants and for preventing TB in adolescents and adults.

“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, adding that the project was carried out in consultation with the European Medicines Agency.

Loureiro also hinted at advance market commitments. “For example, we can guarantee immediate access to the innovation that we are supporting, which is not something that usually you can do with grants,” she said.

Another possibility is developing demand estimations to gauge the need for certain products across member states, commented Loureiro. The aim is to understand if the market is attractive enough to for companies to invest in developing a countermeasure.

Another pull incentive discussed at the event was the possibility of an EU version of the US Food and Drug Administration’s priority review vouchers. PS155344

First Loan Announced

Separately, in related news, the first loan under the HERA Invest initiative was announced on 1 October. This push initiative targets small and medium-sized companies to provide loans to encourage them to invest in R&D. There are two conditions for the funding: that the end product counters priority health threats and that development is based in the EU.

Under the recently announced agreement, the French Company Fabentech will receive a €20m loan to develop a technology platform designed to neutralize deadly viruses and toxins, including their variants.

HERA was created following the COVID-19 pandemic. It focuses on three priority areas: pandemic pathogens, CBRN (chemical, biological, radiological and nuclear) threats, and antimicrobial resistance. Some neglected diseases come under these definitions.