The European Commission will examine specific incentives and a new pricing system to develop innovative antibiotics in its pharmaceutical strategy, in a bid to take a more ambitious stance against the rising threat of anti-microbial resistance (AMR).
Unveiled on Wednesday (25 November), the strategy is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry.
When it comes to AMR, the strategy highlights that the “current incentive models do not provide a sustainable solution,” calling on new business approaches that include incentives for the development of innovative antimicrobials as well as a new pricing system.
AMR claims 33,000 lives in the EU every year, and is also responsible for an annual economic loss estimated at around €1.5 billion. It is expected to become a bigger killer than cancer by 2050.
AMR decreases the capability to treat infectious diseases and threatens the ability to perform routine surgery, the document states.
“What we saw with COVID-19 was the actual impact of antimicrobial resistance,” said Health Commissioner Stella Kyriakides, pointing out that many lives were lost during the pandemic because the pharmaceutical market alone has not been able to develop new antimicrobials.
The Commission is mulling over whether to pilot innovative approaches to research and development (R&D) and public procurement for antimicrobials and their alternatives.
The aim is to provide the so-called “pull” incentives for novel antimicrobials by 2021. 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.
Promoting investments and coordinating the research and manufacturing of novel antibiotics will be also in the mandate of the newly set EU Health Emergency Response Authority (HERA), tasked with strengthening the coordination of operations across the entire health value chain.
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.
However, the strategy points out that measures to reduce excessive and inappropriate use can have the unintended effect of reducing investment in new antibiotics.
Therefore, the EU executive wants to address the problem by reducing the use of antibiotics and incentivising the development of innovative antimicrobials.
Other non-legislative actions envisaged by the Commission include a communication to healthcare professionals and patients promoting prudent use of antibiotics.
The association representing the community pharmacists (PGEU) welcomed the plans to further address AMR. “Community pharmacists are ready to enhance their contribution to keep antibiotics working and to advise patients on the appropriate handling and disposal of pharmaceuticals,” they said in a note.
In 2019, the European Court of Auditors (ECA) published a report that said that more than 99% of funding from the EU budget for AMR-related actions was directed at research, with EU-funded AMR related research exceeding €1.5 billion since 2004.
The majority of this funding has gone towards developing new antimicrobials, alternative treatments and vaccines.
The audit found that due to the complex nature of AMR research, this has not yet yielded any major breakthroughs and research projects were often delayed, concluding that, nevertheless, this research must be guaranteed.
[Edited by Benjamin Fox]