Seizing the opportunity for European leadership on antibiotic development and access

Europe poised to lead in solutions for AMR

Antibiotics are a cornerstone of modern medicine, but we are quickly running out of treatments due to increasing resistance against existing antibiotics, and a lack of new drugs entering the market in the short and long term. The issue is urgent: antibiotic resistance was the cause of over 1.27mn deaths worldwide in 2019, and death rates could potentially reach 10mn per year by 2050. According to European Commission estimates, antimicrobial resistance (AMR) causes approximately 33,000 deaths per year in the European Union, with an annual price tag of some €1.5bn. Development of new antibiotics is hindered by limitations on usage and issues around pricing. What is preventing the development of new antibiotics, and how can we assure access and appropriate use? How can Europe lead the response to the global health security threat of antimicrobial and antibiotic resistance?

As the European Commission prepares to publish an initiative establishing strategies to combat AMR, a Friends of Europe dinner debate, entitled ‘Seizing the opportunity for European leadership on antibiotic development and access’, was held on 8 November 2022, in partnership with the Global Antibiotic Research and Development Partnership (GARDP). Policymakers, health experts, members of the pharmaceutical industry, scientists and patient advocates gathered to explore Europe’s role in antibiotic development and the global fight against AMR. They highlighted the urgency of the issue, despite strong progress made in recent years. Discussions covered the need for solidarity, access and stewardship; the need for infrastructure to support the development of new antimicrobials; and how value is defined and efforts rewarded.

The new pharmaceutical legislation at EU level provides a crucial window of opportunity to introduce incentives that stimulate innovation, allowing Europe to take a leading role in the global AMR crisis.

Peter Beyer, Deputy Executive Director of the Global Antibiotic Research and Development Partnership, led the discussion by describing the advances, such as the not-for-profit Carb-X initiative, made since the GARDP was established by the World Health Organization in 2016. Despite progress, Beyer warned, the battle is far from being won and much work still lies ahead.

Revising the European economic model for antibiotic development is necessary. With a profile similar to orphan drugs in Europe and to medicines for neglected diseases in low- and middle-income countries (LMIC), antibiotics require innovative push and pull incentive mechanisms that benefit both high- and low-income countries. Beyer cautioned on the need to be prudent in choosing which products to develop.

One novel solution proposed would combine older generic antibiotics to strengthen the efficiency and offer protection to existing treatments. “We must be careful and selective with new antibiotics,” cautioned Beyer.

Dr Malin Grape, Ambassador on Antimicrobial Resistance at the Swedish Ministry of Health and Social Affairs, confirmed that AMR will continue to be a priority when Sweden assumes the EU Presidency in January 2023. Key actions will include tackling vulnerabilities in the supply chain revealed by the COVID-19 pandemic. Production of new antibiotics needs bolstering. Grape also cited tackling antibiotic de-registration as “Europe must maintain all the effective tools in the toolbox and prevent loss caused by low revenues”.

Efforts to reduce unnecessary antibiotic use and promote prevention strategies must also be enhanced. “Prevention and responsible antibiotic use are key to a holistic response to AMR,” commented Grape.

Dr Agnes Molnar, Head of Unit at the European Commission Health Emergency Preparedness and Response Authority (HERA), described the need for effective end-to-end solutions for AMR and other health emergencies. These include efficient regulatory processes to bring products to market, support for research and development, establishing methodologies for mapping supply chains, and monitoring stockpiling, stock-outs, procurement and distribution. The European Commission counts on working with member states, the pharmaceutical industry, the veterinary sector, economic institutions and international organisations, such as the WHO, as well as the G7 and G20 member countries, to address the global dimension of AMR. “It is important to work globally and support LMICs,” noted Molnar.

Investment in development needs encouraging. Florence Séjourné, Executive Chief Executive Officer of Aurobac Therapeutics-Beam Alliance, described the precarious fundraising situation for small companies. Potentially effective products are not being developed as venture capitalists are not engaged in antibiotic development. A reliable platform is needed to generate support for small companies developing innovative solutions.

Yannis Natsis, Director of the European Social Insurance Platform, warned that incentive schemes for antibiotic development must take into consideration access and affordability. Health systems have been strained by the COVID-19 pandemic. In Europe, the social protection platform is struggling with competing priorities, including health, unemployment, pensions, inflation, energy, migration flows and the Ukraine crisis. Innovation must, therefore, be balanced with solidarity.

Public awareness must also be enhanced. The common sanitary gestures adopted to prevent COVID-19 should be sustained. Raising public awareness must be part of the prevention and control strategy in Europe and beyond.

The solution to antimicrobial use, development, and supply requires enhanced prevention and control measures combined with incentives for innovative antibiotic development. By capitalising on emerging legislation and strong political momentum, Europe is poised to take a leading role in developing effective solution to AMR.

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Photo by CDC on Unsplash