Antimicrobial resistance has become one of the world’s greatest public health threats. Drug resistance levels have reached unprecedented levels and modern medical care is at risk of falling back into a pre-antibiotic era.
LSE Health was commissioned by the Dutch Government, as part of their 2016 Presidency of the EU, to produce a review of current incentives for antibiotic innovation.
The review provided a platform for discussion among European Ministers of Health and Ministers of Agriculture during the 2016 Ministerial Conference on AMR.
Their findings have now been published by the WHO’s European Observatory on Health Systems and Policies in a report titled Targeting Innovation in Antibiotic Drug Discovery: The Need for a One Health – One Europe – One World Framework. Edith Schippers, the Dutch Minister of Health has endorsed the publication as: “A very thorough analysis of the different initiatives to stimulate research and innovation of antibiotics”.
The report offers an in-depth review and critical analysis of existing European and international initiatives supporting innovation of novel antibiotic drugs. It also includes a set of policy recommendations for improving the global and European research and development agendas for antibiotics.
2010 report commissioned by Swedish government
Since 2009, the LSE has been actively investigating policy and economic strategies to stimulate innovation of novel drugs to fight resistant pathogens.
This publication is a follow up to the 2010 report commissioned by the Swedish government to examine incentive mechanisms for encouraging antibiotic development.
The 2010 report formed the basis for an urgent request by the EU Council for action and sparked the formation of the critical ‘transatlantic taskforce’ (TATFAR): the first major international collaboration to tackle antibiotic resistance.
Recommendations from the work served as the foundation for an EU-level public/private partnership and for US regulatory reform.
The Swedish Minister for Health Care, Public Health and Sport, Gabriel Wikström, has welcomed this new publication commenting: “I would like to congratulate Professor Mossialos and his research team at the London School of Economics, the Dutch EU Presidency and the European Observatory on producing an outstanding follow up to the LSE report for the Swedish EU Presidency on the important and topical issue of stimulating research and development for antibiotics. Addressing the challenge of antibiotic resistance is of the highest priority for the Swedish Government at a national, EU and international level.”
UK Review on Antimicrobial Resistance
In addition, LSE has provided academic input on antibiotic innovation to the UK Review on Antimicrobial Resistance, commissioned by Prime Minister David Cameron in July 2014.
The Review, chaired by renowned economist Jim O’Neill, was tasked with exploring the rise of AMR and providing solutions to address this global crisis. The Review has published a number of thematic reports on key issues of AMR culminating in the release of their final report in May 2016.
Key findings of this latest study:
- total number of antibiotic patents has declined by 34.8% between 2007 – 12
- there are at least 52 products in the EU/US antibiotic development pipeline, but very few of them target the most deadly pathogens or have novel mechanisms of action
- European public investment in antibiotic R&D was €147 million annually between 2007 – 13; estimated US public investment was €234 million in 2015 and €382 million in 2016
- global venture capital in antimicrobial R&D declined by 28% between the two year periods of 2004 – 08 and 2009 – 13; venture capital investment in gram-negative antimicrobials increased by 51%, but still comprises only 12% of total venture capital investment in antimicrobials
- a total of 58 active initiatives and sub-initiatives at global, EU and national levels (UK, France, Germany, Netherlands, Sweden, US, and Canada) directly incentivize antibiotic R&D
- 9 active initiatives indirectly support antibiotic R&D by coordinating strategic actions on AMR
- of the active initiatives, 76% use only push mechanisms, 5% use only outcome-based pull mechanisms, 5% use lego-regulatory policies and 13% only coordinate AMR action and provide no form of R&D incentive
- the vast majority of funding flows through push mechanisms of incentivization; the top three incentives are direct project funding, research collaborations and research grants and fellowships
- there is an unequal distribution of initiatives across the antibiotic value chain that overly favours basic research and early drug discovery
- current set of incentives underserve small- and medium-sized enterprises, which comprise a significant portion of the R&D force
- commercialization-focused pull incentives like end-prizes and value-based reimbursement are underutilized
- there is room for further regulatory harmonization and cooperation between the EMA and FDA, as well as other drug regulatory agencies
- Antibiotic stewardship and patient access goals are poorly integrated into the current set of R&D initiatives
- many initiatives have not explicitly linked their incentives to high-priority medical needs in infectious disease
Download electronic copy of the study