EU pharmaceutical legislation: tackling the AMR innovation challenge for a healthier future

As we observe World Antibiotic Awareness Week, EFPIA emphasises the severe threat posed by antimicrobial resistance (AMR) to EU and global public health. Confronting this complex challenge requires a comprehensive approach, encompassing enhanced surveillance, prudent use, preventive measures, and the development of essential antimicrobials crucial for combating antibiotic-resistant infections.

Among the array of measures, new antimicrobials are expected to deliver substantial benefits to European patients, healthcare systems and society as a whole, as well as cost savings for Member States. While the development of novel antimicrobials remains central to our battle against AMR, the World Health Organization acknowledges that "the clinical pipeline and the recently approved antibacterial agents are insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance."

The ongoing revision of the EU general pharmaceutical legislation underscores the significance of this issue, and we are encouraged by the constructive debates within the European Parliament on the most effective means to incentivise the research and development of novel antimicrobials. Recent analysis by the Center for Global Development found that the new EU antimicrobial incentive program would save 20,000 lives and deliver $15.5bn in total benefits, with a return on investment of 4:1 over the next 10 years.

In light of various proposed solutions, we emphasise the importance of implementing an incentive model that entails a sufficiently large incentive promoting sustainable innovation, aligned with the EU's contribution or fair share of the necessary global incentive, delinked from revenue, and aligned with stewardship. It is crucial that any proposed model is both feasible and implementable within the EU legal framework, avoiding further delays in action. In this regard, the introduction of transferable exclusivity vouchers (TEV) would play a crucial role in reducing the burden and cost of AMR through the development of new antimicrobials.

The pharmaceutical legislation holds the potential to shape the future of EU actions against AMR, and EFPIA stands ready to contribute to this effort. Together, we can effectively address the looming threat of AMR and safeguard the health of current and future generations.