The crisis around antibiotic research is a global problem and would need global solutions, experts at CSE event highlighted
Calling the current antibiotic development pipeline inadequate would be an understatement. Of the 297 antibiotic medicines that are being researched globally, only 77 are undergoing clinical trials, according to a World Health Organization (WHO) database.
This is minuscule compared to over 10,000 drugs for cancer, over 1,800 for neuropsychiatric conditions, and about 1,500 for endocrine, blood and immune disorders.
On July 28, 2023, Delhi-based think tank Centre for Science and Environment (CSE) organised a webinar titled The Crisis of Antibiotic Research and Development to discuss the issue. The webinar was based on CSE’s latest assessment — ‘A Developing Crisis’ — published in Down To Earth magazine, where CSE researchers have highlighted the current status of the antibiotic development pipeline.
The webinar, the first of a multi-part series, was moderated by Sunita Narain, CSE director general. It brought together key stakeholders — James Anderson, executive director, global health, International Federation of Pharmaceutical Manufacturers and Associations, Switzerland; Richard Lawson, senior project manager, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, the United States; Lesley Ogilvie, director of the secretariat, Global AMR R&D Hub, Germany — for an online panel discussion. The key issues discussed are as follows:
The world is currently facing a triple jeopardy, the experts pointed out. First, there is the issue of antimicrobial resistance (AMR) and antibiotics becoming more and more ineffective. Second, there is less research and development in the case of antibiotics and third is the issue of access to new antimicrobials.
The experts recognised that there is indeed a crisis when it comes to antibiotic research and development (R&D). Society and healthcare systems place a low value on antibiotics despite the public health risks of AMR, sending a clear signal to companies that investing in them is not a priority.
This creates a fragmented antibiotic development pipeline that lacks the predictability of funds to encourage the development of a more sustainable and healthier pipeline. Even though there has been progress in terms of antibiotic development, there still is a long way to go to solve this crisis. The crisis of antibiotic research is a global problem and would need global solutions.
The antibiotic development pipeline requires robust and resilient funding. Around $1.8-2 billion goes into AMR R&D every year from the public and philanthropic sectors globally, according to data from the Global AMR R&D hub. Just 23 per cent of this, however, goes into the development of new antibiotics/antibacterials. This is insufficient to meet the growing crisis of AMR.
Push incentives are working but have their challenges, the speakers pointed out. These incentives aim to support innovation, research and development of new antibiotics from the early stages of basic science to clinical trials.
Push incentives lower developers’ costs and risks through financial, tax and technical help. The main limitation of any push funding organisations, however, is that they alone can’t do the job.
Push and pull incentives need to work together. Pull incentives aim to reward new antibiotics with proven scientific viability and relevance to the market. It ensures developers’ financial viability by reducing the risk of insufficient future revenues. On the pull side, there is a need to build on the experience of countries like the United Kingdom, Sweden etc., who are currently implementing pull-based initiatives.
An example of pull incentive that was highlighted was the UK Subscription Model. This model introduced a couple of years ago as a pilot project is based on the idea that negotiation should be around the value of an antibiotic to society as a whole, not just to individuals. That value determines the prefixed amount paid to the company for several years. Even though this model solves some challenges, it would only work if other countries do something similar.
Additionally, there is a need to develop and implement mechanisms for push and pull incentives that ensure a robust and sustainable R&D ecosystem. Experts also emphasised that coordination, collaboration and communication are key to solving the antibiotic R&D crisis.
Access and affordability issues should also be considered while developing antibiotics. New antibiotics which are being developed target the critical priority pathogens and will be kept in ‘reserve’ category and used only when needed (in order to avoid resistance from emerging quickly against them).
However, if companies are assured of predictability, such as being done in the UK subscription model (fixed level of payment to the company), then there could be a possibility of ensuring access to such antibiotics in low and middle-income countries as well. The issue of access and antibiotic development cannot be solved without cooperation between countries and stakeholders.
There were discussions around evolving the Priority Pathogens List into a Priority Indications List backed up by indication-specific target product profiles to guide researchers and developers. Aligning research with priority indications and feasible clinical trials can help improve the productivity of the pipeline. In addition, there is a need to leverage the infrastructure created during COVID-19 Pandemic.
Moreover, it is necessary to understand what a promising pipeline looks like and set targets for achieving it. If there are no targets set on what needs to be done, all the discussions happening will become much more difficult going ahead. The Global Leaders Group on AMR is in a very important position to convene and bring together these conversations ahead of the 2024 UN High Level meeting on AMR.
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