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Imagine a world where even the most routine operations become life threatening and treatments for diseases such as cancer are just too dangerous to administer. After decades of medical progress, it may seem far-fetched, but the emergence of antimicrobial resistance (AMR) makes this a very real and present danger.
Today, more than 700,000 people die globally every year due to AMR, and without concerted, collective action this figure could rise to more than 10 million people annually by 2050. To put that figure in context, it is double the estimated death toll of SARS-CoV-2. The number of bacteria, viruses, fungi and parasites resistant to therapies is growing while our arsenal of effective weapons is depleting. These facts combine to make AMR one of the biggest health challenges of our time.Whether it is tackling pandemics or action on climate change, we have learned that progress requires collective effort. Industry has been acting on many levels and continues to contribute with concrete solutions to a range of challenges. The research-based pharmaceutical industry has been playing a critical role, putting forward investment in AMR R&D and policy proposals that can help us find solutions to this silent pandemic.
While the health impact is sobering, the economic impact is staggering. The cost of AMR to the global economy could be up to $100 trillion, which, according to the World Bank, is a similar scale to the 2008 global financial crisis.
Inaction on AMR is simply not an option.
Experts have been raising the alarm for years; awareness is rising, but concerted action is still thin on the ground. We are now in the position where many see the dangers, but finding solutions has been more elusive. What we know is that inaction on AMR is simply not an option.
The world urgently needs new antibiotics, but there are few in the pipeline because of a paradox: despite the huge societal costs of AMR, there is no viable market for new antibiotics. They are used sparingly to preserve effectiveness, so developers do not recoup their investment. The result is a huge public health need for new antibiotics, but a lack of funding for antibiotic R&D, particularly the later stages of clinical development, creating a “valley of death” between discovery and patients.
There are some signs of progress at a global and European level. The World Health Organization has listed AMR among the top global health threats while the Pharmaceutical Strategy for Europe recognised the need for action on AMR and will be critical in setting out the path forward in Europe.
We are proposing a series of tangible measures that can help to boost the pipeline of new antimicrobials that the world needs.
As an industry, we are proposing a series of tangible measures that can help to boost the pipeline of new antimicrobials that the world needs.
The AMR Action Fund is a ground-breaking partnership from over 20 leading biopharmaceutical companies, including Boehringer Ingelheim. Launched in 2020 to bridge the gap between science and patients on AMR, the fund will invest $1 billion to spark the development of innovative antibiotics. Companies and partners like the European Investment Bank, Wellcome Trust, the Novo Nordisk Foundation and the Boehringer Ingelheim Foundation are giving dedicated financial support as well as access to the deep expertise and resources of large pharmaceutical companies. With this, we believe we can strengthen and accelerate antibiotic development. And there are other smaller initiatives such as INCATE, which concentrates on bridging basic research from state-related research institutions with that of pharmaceutical companies. But all of this is only a temporary solution. There is an urgent need for policy reforms to create the market conditions that enable sustainable investment in antibiotic innovation.
New pull incentives, such as transferable exclusivity extensions (TEE) and subscription models backed by meaningful resources, are required to give companies the confidence to start reinvesting in antimicrobial development. The PASTEUR Act in the United States could be a ground-breaking global model in this regard because it contains both incentives for successful investment in research and careful use of new antibiotics.
We need to accelerate the creation of a vibrant and sustainable innovation ecosystem to support R&D for new antimicrobials.
At the European Union level, a pull incentive in the form of a TEE would be a powerful tool to incentivize antimicrobial R&D while promoting good stewardship. The developer of a qualifying antimicrobial would be awarded a TEE for a specified period of additional exclusivity. This can be used within the portfolio of the company that developed the new antimicrobial or sold to another company. It has some advantages: the value is not tied to the sales of antimicrobials, it can provide the right level of incentive to innovators, administrative costs are comparatively low, and there would be no need for a separate funding appropriation. Optimally, the extension would need to be designed so its value is linked to the societal value of fighting AMR. COVID-19 has demonstrated the huge impact of a global threat on public health and the economy. But unlike COVID-19, AMR is a predictable and preventable crisis. Now, more than ever, we need to accelerate the creation of a vibrant and sustainable innovation ecosystem to support R&D for new antimicrobials. AMR is a real threat that can be overcome if we work together. Let us act now, let us act together, let us solve it.
Source: Politico
