European pharma group wants to create PRV-like system to spur antibiotics R&D

New research funded by a European pharma industry group is looking to reinvigorate antimicrobial R&D with a system that’s similar to the priority review voucher systems in the US, which spurs new research in rare pediatric diseases, rare tropical diseases and medical countermeasures.

Nathalie Moll

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

“The system could bring two new antibiotics a year to patients over the next decade, preventing some of the 400,000 deaths associated with AMR every year in the EU,” EFPIA claims.

But the research notes that the increased exclusivity will come at a cost as 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 the exclusivity extension, but the report says, “It is clear from our case studies that the benefits outweigh the costs for all the countries and case study examples.”

EFPIA Director General Nathalie Moll added:

Numerous ideas to stimulate new research have been proposed across the public and private sectors, and this research leaves little doubt that TEE is the best solution for Europe. Not only can TEE deliver new antibiotics it will bring significant economic benefits to each Member State.

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

“TEE has the advantage of providing a sufficiently powerful incentive to stimulate development of new antimicrobials that is feasible and relatively straightforward to implement at the joint EU level, with minimal up-front administrative costs to the European Medicines Agency (EMA) and a cost that is spread across all European” member states, the report adds.

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