Challenges and opportunities for continued access to effective antibiotics - what role for the EU?

Abstract Large pharmaceutical companies have withdrawn from antibiotic R&D because of the high risk of failure and because antibiotics are less profitable than other areas; small and medium-sized enterprises (SMEs), which now drive antibiotic R&D, face difficulty securing funding for preclinical and early clinical trials, and risk significant economic losses when launching new antibiotics. To reinvigorate the antibiotic pipeline, a holistic package of aligned incentives is required, which takes into account public health factors, improves return of investment while supporting SMEs, and considers operational feasibility including potential political, regulatory, legislative, industry and financial hurdles. This presentation will highlight the main options in this area. Improving access to effective antibiotics requires both short- and longer-term measures. Reducing regulatory administrative hurdles, engaging in good procurement practice, increasing joint purchasing efforts, and considering payment models that de-link revenue from sales can keep older (but effective) antibiotics on the market by ensuring their economic viability. Strengthening the mapping of production capacities and product availability can improve transparency and identify options for action, while stockpiling and strengthening manufacturing capacities within and outside of the EU can boost the supply chain itself. Concrete measures and their feasibility will be briefly presented. The EU has a major role to play by supporting antibiotic R&D and engaging with other international efforts to promote optimal deployment of incentives, by ensuring that the lack of access to appropriate and effective antibiotics is recognized as a threat to global health security, and by building on its relationships with international institutions to act as a facilitator in the global space towards ensuring synergies among existing structures, communicating the cost of inaction, and supporting national and regional initiatives. Speakers/Panelists Danilo Lo Fo Wong Division of Country Health Programmes, WHO/Europe, Copenhagen, Denmark Malin Grape Ministry of Health and Social Affairs, Stockholm, Sweden Lieven De Raedt Federal Public Service Health, Food Chain Safety and Environment, Brussels, Belgium