Ensuring the availability of off-patent antibiotics

The Commission supported the French authorities in their efforts to design and implement measures ensuring that ‘off-patent’ (usually generic) antibiotics remain available for human and animal use.

Context

Too often, essential off-patent antibiotics are subject to shortages caused by production or supply disruption, or are not available in specific markets. The recurrent shortages and lack of availability of many different antibiotics in the EU is affecting healthcare and patient wellbeing and is increasing the risk of antimicrobial resistance (AMR) in both humans and animals.

Support delivered

The support provided by the Commission and the World Health Organization (WHO) was delivered in close collaboration with all French stakeholders in the human, veterinary and environmental sectors (One Health approach) over three years.

The support measures consisted of:

• Improving knowledge and awareness of factors leading to shortages and lack of availability of off-patent antibiotics in the human and veterinary sector;
• Designing measures to address the root causes of shortages and lack of availability of off-patent antibiotics, and share insights and lessons learned with stakeholders including at the European level;
• Monitoring and evaluating the implementation and impact of selected measures in France.

Expected results

The French authorities initiated and completed several actions that address root causes of shortages and lack of availability of off-patent antibiotics and in turn, improve access to antibiotics over time. The project was in line with several EU initiatives including the European One Health Action Plan and the Pharmaceutical Strategy for Europe.

More about the project

Antibiotic availability and shortages in the human and animal sectors in France (publication)