Ensuring the availability of off-patent antibiotics

The Commission supports French authorities’ 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) will be delivered in close collaboration with all French stakeholders in the human, veterinary and environmental sectors (One Health approach) over three years.

The support measures consist 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

Address root causes of shortages and lack of availability of off-patent antibiotics. This should turn, improve access to antibiotics over time. The project is in line with several EU initiatives including the European One Health Action Plan and the Pharmaceutical Strategy for Europe. Outcomes of the project will be disseminated to other Members States.

More about the project

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