EU policymakers are being urged to consider the full range of new incentive systems and pilot innovative approaches to tackle antimicrobial resistance (AMR), including Netflix-style subscription services and pull incentives.
Misuse and overuse of antibiotics in recent years has led some microorganisms, also called superbugs, to develop antimicrobial resistance, meaning that medicines become less effective and infections persist in the body, increasing the risk of spread to others.
The development of novel antibiotics is seen as a solution to cope with this ‘silent pandemic’ that decreases the capability to treat infectious diseases and threatens the ability to perform routine surgery.
However, the availability of new antibiotics in many countries across the EU has proved to be particularly problematic as some of them are not commercially launched even despite and after being approved by the authorities.
Remko van Leeuwen, CEO of the biotech company Madam Therapeutics, which is active in the field of AMR, started his company in 2011 when this particular area of development was commercially not lucrative.
“I’ve started because the medical need [to fight AMR], but the world has changed since 2011 and [… AMR] is far less attractive than 10 years ago,” he said at a recent event.
Van Leeuwen, who is also a board member of the BEAM (Biotech companies in Europe combating antimicrobial Resistance) Alliance, said that the fight against this new potential pandemic needs to be supported as returning investment by sales alone will not work.
According to him, the cost of bringing and keeping antimicrobials to the market is too high to offer an incentive for a private company to invest.
One year ago, the global pharmaceutical industry invested nearly $1 billion US dollars in the AMR Action Fund with the aim of bringing two to four new antibiotics to patent by 2030.
Global charitable organisations and development banks were also behind the initiative and contributed.
But the problems do not stop at the costs for the development, explained Kevin Outterson, executive director at CARB-X and professor of law.
He pointed out that there are drugs approved by the European medicine agency (EMA) and not yet launched in other EU countries because the additional cost of launching is not worth it, compared to the reimbursement they receive.
“We also noticed that the dramatically lower number of launches in Japan and in Canada, which should be a serious issue for concern: if this is difficult in high-income imagine launching in places like Nigeria, South Africa, or India,” he added.
Not just one model
AMR is listed as one of the top priorities in both the recently proposed pharmaceutical strategy and the EU4Health Programme designed to strengthen the resilience of health systems.
The rotating EU presidency currently held by Slovenia has also listed improving accessibility to and availability of medicines, especially where there may be a lack of commercial interest – such as in the case of antimicrobials – as one of their health priorities.
In particular, the EU executive wants to address the problem by reducing the use of antibiotics and incentivising the development of innovative antimicrobials.
Promoting investments and coordinating the research and manufacturing of novel antibiotics will be also in the mandate of the newly established EU Health Emergency Response Authority (HERA), tasked with strengthening the coordination of operations across the entire health value chain.
Since the One Health approach launched in 2017 is seen as a reference as it highlights interlinks across humans, animals and the environment where they live, the hopes for positive development in this field also fall on the implementation of veterinary medicinal products and medicated feed regulations starting from January next year.
According to Yannis Natsis, policy manager at European Public Health Alliance (EPHA). this is the signal that the EU is steering meaningful innovation instead of writing a blank check to industry.
“Pharmaceutical companies have dropped the ball on AMR for decades now. No new class of antibiotics has been discovered in over 30 years using the usual market-based business model of the pharmaceutical industry,” he said.
A ‘Netflix-style’ subscription service, regularly paid from governments to the pharmaceutical industry, has been recently proposed and experimented in the UK to help incentivise the creation of novel antibiotics.
For BEAM’s van Leeuwen, the subscription system brings the advantage that makes investments attractive for people who are involved in product development because they have guaranteed revenues.
However, the subscription system alone is not enough predictable for investors, according to the director-general of the pharmaceutical EU’s trade association Nathalie Moll.
“We also need that overarching European ‘pull’ incentive, that really reassures investors,” she said.
The ‘pull’ mechanism pay for results rather than for the effort on the part of researchers, creating incentives for private sector engagement by creating viable market demand.
With the aim of providing these ‘pull’ incentives for novel antimicrobials by the end of 2021, the Commission is mulling over whether to pilot innovative approaches to research and development (R&D) and public procurement for antimicrobials and their alternatives.
“We put additional funds to R&D budget of the European Union, but still we don’t see results,” said Andrzej Rys, director for medical products and innovation at the Commission’s DG Sante, adding that this difficulty led the EU executive to a reflection on the pull model.
[Edited by Benjamin Fox]
