'Piloting a framework for analysing the public contributions to R&D: new antibiotics in focus'.

Background: Within the context of increasing transparency around public contributions, a framework for reporting and analysing public contributions to research and development (R&D) was previously developed and is piloted here using the example of antibiotics. The aim of this work is to check whether the category system is feasible, to revise and adjust the granularity of the category system where necessary, and to expand the range of sources for detailed analyses.

Methods: All antimicrobial medicinal products in development, discontinued and approved in the last 10 years were identified in the literature. Thereafter clinical trials and company information was searched generating a list of 56 compounds where primarily small to medium-sized enterprises (SMEs) were involved in antibiotics development. Information on clinical trials, university spinouts and public funding for SMEs was then gathered from various sources. The framework for classifying public contributions was then applied.

Results: We found that around one-third of antibiotics are developed by SMEs. We identified numerous public funding sources for SMEs that develop antibiotics. At both early-stage and late-stage development, public research funding is the most common public funding reported by SMEs, ahead of other public sources like public equity funds, private-public partnerships and philanthropic sources. A deep-dive into one antibiotic drug, Venatorx, revealed public funds investment of approximately $655 million, dwarfing private investment funds. We found the classification framework generally practicable and we suggest recommendations to improve its granularity and applicability.

Conclusion: In this paper we piloted and revised a framework that has been developed to classify types of public contributions to pharmaceutical products at different stages of development. The framework, together with work we have done on identifying sources for funding, can be applied to support pharmaceutical price negotiations that reflect the level of public contribution to product development. EU Clinical Trials Register identifier: 0004-2083-2207. EU Clinical Trials Register identifier: 0003-1754-9422.