The global response to AMR must not fail to address the needs of neglected patients

Manica BalasegaramManica Balasegaram, Director, Global Antiobiotic Research and Development Partnership
[June 2016]

Far from being an apocalyptic fantasy, a post-antibiotic era in which common infections and minor injuries can kill has become a very real possibility. Of late, media headlines about ‘the end of the road’ for antibiotics have been plentiful. The latest case in May this year to receive a good deal of attention was of a patient in the US found to be carrying bacteria resistant to antibiotics of last resort.

With antibiotic resistance (AMR) clearly affecting all corners of the globe and countries of all income levels, it is not difficult to see why the problem registers on global leaders’ radar. The World Health Organization’s (WHO’s) Global Action Plan on Antimicrobial Resistance (GAP-AMR) adopted in 2015 was an urgent first step towards addressing the systemic challenges causing and resulting from AMR. The Global Antibiotic Research and Development Partnership, a concrete outcome of both the GAP-AMR and DNDi’s long-term business plan process, has demonstrated how political momentum can lead to swift action. In less than two years the joint DNDi-WHO partnership garnered the financial and political support required to build an organization that will develop new antibiotic treatments and promote sustainable and equitable access.

Due to the inherent risks of AMR, research and development (R&D) for new treatments has to maintain a global focus. While product development partnerships (PDP) have traditionally focused on the needs of low- and middle-income countries, it is critical to ensure that both developing and developed countries are brought into the same momentum, albeit with different challenges in terms of conservation of and access to antibiotics. The Global Antibiotic Research and Development Partnership will nevertheless pay particular attention to the needs of low- and middle-income countries and vulnerable populations from the outset when priorities are set, potential new therapeutic products are designed, and access and stewardship strategies are integrated into projects.

While the Global Antibiotic Research and Development Partnership is only one actor in the field of AMR, we will focus our efforts on public health priorities, including those unlikely to be addressed by other R&D actors. We will target unmet public health needs, coordinate with other actors in order to reduce duplication of research and maximize potential through partnerships, and shape our interventions where needs are greatest. Examples of possible activities include: developing new treatments for neonatal sepsis and gonorrhoea; developing a combination screening and drug development platform to optimize the use of existing antibiotics; and an antibiotic ‘memory recovery’ initiative to re-evaluate and make knowledge and resources available on withdrawn, abandoned, or forgotten antibiotics.

We will also work on ensuring sustainable access and look at alternative incentive mechanisms beyond conventional grants. The UK government’s AMR Review, in its final report, recently proposed concrete actions to tackle the emerging antibiotic resistance crisis. It confirms that the predominant system of financing and steering pharmaceutical R&D is failing to develop and deliver the drugs, vaccines, and diagnostics we need. Current incentive mechanisms will not replenish the empty antibiotic R&D pipeline, as they rely on recouping the costs of investment in research through the sales of the finished product.  We need to change tack.

Alternative business models and incentives therefore need to be tested, including ‘delinkage’ of the cost of R&D from sales and price of treatments that promote appropriate use while facilitating equitable access for all. We will endeavour to explore these, while applying norms or principles that allow for the fruits of medical innovation to be accessible and affordable.

But AMR is only one area where there are R&D needs of public health importance. The recent extension of DNDi’s portfolio to new diseases is a testament to the range of different research gaps that persist today. While there are of course specificities that distinguish AMR from other public health issues – not least the fact the development of any new product needs to be accompanied by efforts to ensure conservation – the core elements of DNDi’s patient needs-driven response are the same regardless of the disease: gap identification, prioritization, coordination, sustainable financing, and norms that ensure affordability and sustainable and equitable access.

Importantly, these core elements should be included in the Global Development and Stewardship Framework for AMR currently under review by the WHO, and we believe it should be seen as a first step toward developing an overarching global agreement on biomedical innovation for all R&D actors and all areas of public health importance.

Beyond its immediate AMR mission, one of the opportunities of the Global Antibiotic Research and Development Partnership is thus to explore how these core elements, which would ensure patient needs are taken on board and addressed, might be applied in practice to a public health problem on a global scale.

In the coming months, as we build the Partnership’s scientific strategy, initial R&D portfolio, and start‐up team, we will keep patient needs at the centre of our work.

 

Manica Balasegaram, Director, Global Antiobiotic Research and Development Partnership

 

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