Antibiotic resistance, responsible for an estimated 700,000 deaths globally every year. In the US alone, antimicrobial resistance (AMR) is estimated to cost the healthcare system an annual $20-35 billion, with additional costs to society for lost productivity as high as $35 billion per year. These antibiotic resistant infections threaten people’s lives and greatly increase costs of care.
Unlike many other public health priorities, antimicrobial resistance is attracting political attention at the highest level. Conservation and rational use of antibiotics, along with stimulating research and development of new treatments to address antimicrobial resistance (AMR), are now recognised as critical imperatives.
Research and development forms an essential part of the WHO’s Global Plan of Action on AMR. The 2015 G7 Leaders’ Declaration acknowledged the need for the development of new antibiotics, therapies, vaccines and diagnostics, with a subsequent Health Ministers’ Declaration both calling for a UN High Level Meeting in 2016 on AMR that may include R&D, and making note of specific R&D incentives to develop new antibiotics, including a WHO-supported R&D facility that has since been established. It is expected that the 2016 G7 will continue to look in greater depth at incentive models for the development of new drugs and diagnostics.
Yet the current biomedical innovation system is ill-equipped to address the challenge of R&D for antimicrobial resistance. While it is largely uncontroversial to say that the current patent-based model of medical innovation is at odds with the need for strict conservation of new antibiotics, progress to develop new incentive models has so far been slow. European efforts to explore and test new, commercially-viable R&D models through the Innovative Medicines Initiative have so far shown little progress, and US initiatives such as the funding of research projects through BARDA or the GAIN Act, for example, have either focused on providing R&D subsidies to industry or further extending product monopolies, without consideration of how this will be at odds with the necessary subsequent stewardship, access and conservation strategies.
The Drugs for Neglected Diseases initiative, with the support of WHO, is establishing a global antibiotic research and development facility, (GARD) which will focus on global health needs and ensure that any new products are also suitable for resource-limited settings. This facility will be based on the principles of de-linkage, in that the costs of R&D will be financed through other means than high prices and sales volumes. Such a model looks particularly promising in addressing the incentive challenge of ‘creationconservation’ that antibiotic R&D entails, and addresses the access and suitability challenges for developing countries.
Despite such promising measures, governments still need to work together to establish a systematic approach to incentivise the development of appropriate drugs and diagnostics to address antibiotic resistance. Collective action, whether via WHO, the UN or even the G20, is urgently needed to ensure appropriate incentives are able to respond to this medical need.
|Date of upload: 17th Jan 2017|
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