Partner, Novo Holdings and Director, REPAIR Impact Fund
Professor Dame Sally Davies
UK Special Envoy on Antimicrobial Resistance
But the UK and Sweden may have answers. They are tackling the antimicrobial crisis head on by taking a new approach that turns the current payment system for innovative drugs on its head.
Antibiotics have been the best deal in healthcare for decades. However, the relatively low cost of drugs, coupled with growing resistance, and declining investment in research and development means that Europe’s medicine cabinet is now looking decisively bare.
“We have got a broken system for the R&D and marketing of new antibiotics,” confirms Professor Dame Sally Davies, UK Special Envoy on Antimicrobial Resistance.
“We’re seeing rising resistance, but with more medical advances which rely on anti-infectives, we’re running out of options.”
In response, the UK and Sweden are pioneering innovative new subscription approaches to address the current market failures by using pull incentives to ensure we have a pipeline of drugs that are fit for purpose and accessible to those who most need them.
A trial of the subscription model was launched in the UK over the summer and, from April 2020, the NHS will pay two pharmaceutical companies a set amount for access to their antibiotic product. If successful, it’s hoped that other countries would roll out similar, innovative systems and create meaningful incentives for global investment in R&D.
Addressing market failures
To put things in context, no new class of antibiotics has been discovered and made available for routine treatment since the 1980s and of the 25 new chemical entities that were registered between 1999 and 2014, only 12 had registered sales in more than 10 countries.
These statistics paint a worrying picture and highlight the need for action. Europe is now at risk of missing out on new treatments because antibiotic developers cannot justify the expense of registering and launching their drugs developing here.
Aleks Engel, Director of the REPAIR Impact Fund at Novo Holdings, who invest in the discovery and early-stage development of therapies targeting resistant microorganisms, believes the severity of the situation can’t be underestimated.
“Even the drugs that, despite the difficult economics, manage to prove themselves in clinical development are not being registered and sold in Europe, because they are owned by under-capitalised small and medium sized companies that cannot afford to launch new products or even put in a new drug application here,” he says.
“The Netflix model,” as Engel refers to it, seeks to address the system failures by providing a guaranteed level of revenue so drug developers know precisely what they are going to get, regardless of how much of the drug they sell.
Ensuring good stewardship
While this approach provides security for the drug developers, there are significant expectations too.
The two antibiotics currently being contracted by the UK in the trial will capture benefits to the NHS and wider society; they will also be judged for their commitment to antimicrobial and environmental stewardship; and have robust plans for surveillance.
The overuse and misuse of antibiotics have been major contributing factors to antimicrobial resistance, so the model seeks to remove the incentive for companies to sell more than is absolutely necessary.
“Better stewardship equals longer efficacy”, confirms Davies.
Underpinning modern medicine
The reality is, antibiotics underpin modern medicine. Whether it’s transplant surgery or ongoing care of patients undergoing chemotherapy, success relies on robust, effective antibiotics being readily and affordably available worldwide. The UK’s Global AMR Innovation Fund supports innovation around the world to develop new vaccines, treatments and tests that are specifically tailored to low- and middle-income countries.
With consistent stewardship, nations would not just save antibiotics or build back from COVID-19 but build up global preparedness for the future.
Drug resistance knows no boundaries and failure to act will have repercussions across the globe.
“We need much more global collaboration. If these approaches are feasible, other counties will try similar innovative mechanisms,” confirms Davies.
Progressing the battle against antimicrobial resistance requires both courage and investment. The UK and Sweden is taking the lead but need others to follow.