How to improve patient access to novel antibiotics in Europe: Recommendations for policies to fight AMR (Guest blog)

In the context of the European Antibiotic Awareness Day, the European Centre for Disease Prevention and Control (ECDC) published a series of reports which confirm the considerable health burden of infections with antibiotic-resistant bacteria in the EU. The ECDC reports shows that drug-resistant infections are increasing faster than expected, in particular in healthcare settings, causing more than 35,000 deaths yearly. WHO has declared AMR to be one of the top 10 global health threats facing humanity, and the EU’s HERA has listed it as one of the top three health threats.
Without antibiotics to prevent and treat infectious complications, surgery, caesarian sections, chemotherapy or organ transplantations would not be possible. Yet, as bacteria become resistant, antibiotics lose their effectiveness and treatments that we currently take for granted as routine procedures will become increasingly risky.
To address the growing threat of antimicrobial resistance (AMR), we must ensure the appropriate use of our existing antimicrobials and also ensure a robust pipeline of new antimicrobials is under development to keep pace with resistance. However, we do not have the pipeline we need due to the unique market challenges of novel antimicrobials.

Sophie Noya

Sophie Noya is Director Public Policy at MSD. She has been actively engaged in the topics of digital, diabetes...
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A recently published White Paper on "How to improve patient access to novel antibiotics in Europe" seeks to highlight the significant barriers existing at the national level - related to value-assessment methods and pricing and reimbursement - that are hampering patient access. At the same time, the White Paper proposes concrete recommendations to address those national barriers, including HTA reform and the introduction of models delinking volume from revenue.

There is no ‘one-size-fits-all’-approach and only a package of tailored incentives will help address the economic challenges of the antimicrobial market and promote antimicrobial R&D.

While the measures proposed in the White Paper focus on the national level, the European Union must also play its role and put in place an EU-wide incentive. The upcoming revision of the pharmaceutical legislation represents a one lifetime opportunity to address the pipeline challenges by establishing a Transferable Exclusivity Extension for novel antimicrobials, ensuring a sustainable return on investment.
Unlike COVID-19, AMR is not taking us by surprise, we know this could well become the next pandemic. The time to act is now so that we can protect today’s and future patients against AMR!