According to Maria Daniel Loureiro, the EU’s Health Emergency Preparedness and Response Agency (HERA) will pre-market and pay for late-stage drug research needed to support marketing authorization applications. The researchers say they are considering various triggers for neglected diseases. Intelligence Analyst at HERA.
The goal is to make the development of such products more attractive by improving market conditions, he said at the European Health Forum Gastein (EHFG) conference in Austria on September 25. said.
Push incentives are designed to reduce research costs and encourage research and development through grants, funding, tax credits, etc. Pull incentives, on the other hand, aim to make R&D more attractive by reducing financial risk and increasing product market viability.
Important points
It is time to put more emphasis on increasing incentives for late-stage development of drugs for neglected diseases in the EU.
Pull incentives could include late-stage development payments required for regulatory filings and pre-market commitments.
Demand estimation helps companies determine whether the market for a particular product is viable.
pull and push
The coronavirus pandemic and the monkeypox crisis were “an important learning experience for EU officials,” Loureiro said. They not only showed how local threats can transform into transnational and global threats, but also noted that “a wide range of situations that can pose a public health threat can be exploited.” demonstrated the importance of maintaining a strong portfolio of medical countermeasures.
However, there is currently too much emphasis on push incentives that can fund early-stage research but do little to support late-stage development and actually bring products to market. , several speakers at the event agreed.
Loureiro believes the EU has a role to play in improving this problem, aligning the interests of developers with the needs of public health. He commented that HERA is considering a number of pull-type incentives to “guarantee market interest in EU competitiveness and development”.
One such possibility is for HERA to pay for late-stage drug research required to support a marketing authorization application. She noted that HERA had recently provided €22 million ($24 million) in funding to accelerate the final stage development of Not Neglected Disease products. This is Biofabri’s MTBVA vaccine as an alternative to BCG vaccination in infants and for the prevention of tuberculosis in adolescents and adults.
“We were paying for the clinical and non-clinical research necessary to build the portfolio that we would submit to the EMA for market access,” she said, adding that the project was carried out in consultation with the European Medicines Agency. He added that it was done.
Mr. Loureiro also hinted at prior engagement with the market. “For example, we can guarantee immediate access to the innovations we support, which is something that grants typically cannot achieve,” she said.
Another possibility is to develop demand estimates to gauge the need for specific products across member states, Loureiro commented. The goal is to understand whether the market is attractive enough for companies to invest in developing countermeasures.
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 financing announced
Separately, in related news, the first financing under the HERA Invest initiative was announced on October 1st. This promotional initiative provides loans to small and medium-sized enterprises to encourage investment in research and development. Funding is subject to two conditions. The final product is prioritized to combat health threats and development is based in the EU.
Under a recently announced deal, France’s Fabentec will receive a €20 million loan to develop a technology platform designed to neutralize deadly viruses and toxins, including their variants. You will receive it.
HERA was established in response to the COVID-19 pandemic. It focuses on three priority areas: pandemic pathogens, CBRN (chemical, biological, radiological, nuclear) threats, and antimicrobial resistance. Some neglected diseases fit these definitions.
