European pharmaceutical group wants to create a PRV-like system to boost antibiotic R&D – Endpoints News


New to research funded by a European pharmaceutical industry group seeks to reinvigorate antimicrobial R&D with a system similar to priority review voucher systems in the United States, which stimulates new research on rare pediatric diseases, rare tropical diseases and medical countermeasures.

Nathalie Moll

As the need for new antibiotics is urgent, EFPIA is calling for a Transferable Exclusivity Extension (TEE) voucher scheme where developers of new antibiotics can earn a voucher which can then be used to extend the exclusivity of a another drug for a period of time, or sold to another company, thereby paying for antibiotic research.

“The system could bring two new antibiotics a year to patients over the next decade, averting some of the 400,000 AMR-associated deaths each year in the EU,” says EFPIA.

But the research notes that increased exclusivity will come at a cost because generics won’t come to market as quickly. France, Germany and Italy could end up losing more than $100 million per year for each new antibiotic due to extended exclusivity, but the report states: “It is clear from our studies of cases that the benefits outweigh the costs for all countries and cases. study examples.

Nathalie Moll, Director General of EFPIA, added:

Many ideas to stimulate new research have been proposed in the public and private sectors, and this research leaves no doubt that the EET is the best solution for Europe. Not only can TEE provide new antibiotics, but it will bring significant economic benefits to every Member State.

The report also highlights the need to invest in maintaining Europe’s arsenal of effective antimicrobials.

“The EEO has the advantage of providing a sufficiently powerful incentive to stimulate the development of new antimicrobials which is feasible and relatively simple to implement at common EU level, with minimal initial administrative costs for the European Food Safety Agency. medicines (EMA) and a cost that is spread across all European member states,” the report adds.


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