EU Observatory & the Swedish EU Presidency in policy brief on the EU’s chance to address antibiotic resistance and leverage its role in global health
ew policy brief from the Observatory with and for the Swedish Presidency of the Council of the EU details concrete steps for urgent action. As countries around the world run against the clock to respond to antimicrobial resistance (AMR), a new report offers tailored guidance to help policy-makers in the European Union (EU) foster sustainable innovation and improve access to effective antibiotics.
An important component of the much-needed action to tackle one of the biggest public health threats the world faces is ensuring that antibiotics are effective and available widely and consistently. The new policy brief, published by the European Observatory on Health Systems and Policies under the auspices of the Swedish Presidency of the Council of the EU, outlines possible solutions to the challenges of research and development (R&D) for antibiotics and their reliable supply.
The detailed report becomes available soon after the EU has adopted a Council recommendation that for the first time sets out targets for antimicrobial consumption and antimicrobial resistance in human health at EU level. It has also updated its global health strategy while it is in the process of revising its overall regulatory framework on pharmaceuticals. This puts the EU in a unique position to become a global leader in responding to the significant threat that antimicrobial resistance poses to human and animal health as well as global development, economies and food security.
A package of incentives to help develop new antibiotics
The World Health Organization describes the antibiotic pipeline as “insufficient” to meet the challenge of antibiotic resistance. Only a handful of new antibiotics have been developed over the last few decades, and almost none is sufficiently innovative to slow down resistance.
Various barriers hinder the development of novel antibiotics. One example is the withdrawal of most large pharmaceutical companies from antibiotic R&D. Not only the risk of failing is high, but also antibiotics are a lot less profitable than other medicines. This is because they are generally used only when necessary and for treatments of a short duration. This results in low sales volumes, which combined with the generally low prices leads to limited revenues for manufacturers. On the other hand, small and medium-sized enterprises which now drive antibiotic R&D face difficulties in securing funding for preclinical and early clinical trials. They are also at significant risk of economic losses when launching new antibiotics.
“We need the EU to invest towards addressing the gap in the antibiotic pipeline, otherwise it will risk being left behind international developments,” warns Professor Elias Mossialos, one of the authors and research director of the European Observatory on Health Systems and Policies at the London School of Economics and Political Science.
“We have found that rather than focusing on one incentive for pharmaceutical developers, we need a holistic package of incentives to address multiple factors at once. These include public health factors such as environmental health and high-burden resistant infections, market factors such as return on investment, and implementation factors such as governance and international coordination”.
The report states that push incentives, such as direct funding and grants, can reduce the cost of R&D and have already improved the quality of the pre-clinical pipeline to some extent. Pull incentives such as reimbursement reforms are also needed to increase the potential revenue and create more viable markets for antibiotics.
Better access to antibiotics that (still) work
A fragile supply chain continues to drive recurrent shortages of essential antibiotics in many EU Member States. This fragility is worsened by the fact that active pharmaceutical ingredients often come from only few suppliers, typically in India and China, and that there is a limited number of generic manufacturers. What is more, manufacturers prioritise larger markets because smaller markets are not profitable.
Dr Dimitra Panteli, co-author of the brief and innovation lead at the European Observatory on Health Systems and Policies in Brussels, explains: “In a catch-22, when effective antibiotics are not available, patients will need broader spectrum or less optimal options, which in turn precipitate AMR further. This brief provides a range of solutions to improve access to older antibiotics, from relaxing regulatory requirements to increasing cross-country collaboration, strengthening manufacturing and optimising stockpiling approaches.”
EU action for a global problem
This brief encapsules the evolution of strong and sustained Swedish leadership in the field of AMR. In 2009, Sweden was able to effectively use the Presidency of the Council of the EU as a platform to advocate for EU-level action leading to the decision to develop an EU action plan in this field. During their Presidency of the Council of the EU in 2023, which ends this month, Sweden has called on EU Member States to reflect on the development over the last 14 years, to consider what priorities for action remain.
“AMR can be regarded as an ongoing pandemic, and as such it knows no borders,” reminds Dr Malin Grape, Sweden’s Ambassador on Antimicrobial Resistance. “We are all under immense pressure to address this threat. The Swedish Presidency has throughout these months worked to provide opportunities for Member States and EU institutions to leverage progress and identify concrete actions that we must take – together. This is why Sweden keeps addressing this issue in the EU and internationally.”
Learn more about the policy brief, How can the EU support sustainable innovation and access to effective antibiotics?: Policy options for existing and new medicines
