European Antibiotic Awareness Day 2013: 'Everyone is responsible'

18 November 2013

The European Medicines Agency supports European Antibiotic Awareness Day (EAAD), which is taking place today. EAAD is an annual European public health initiative, organised by the European Centre for Disease Prevention and Control (ECDC), which aims to raise awareness of the threat to public and animal health of antibiotic resistance and the importance of prudent use of antibiotics. The theme of this year's EAAD is 'Everyone is responsible'.

The European Medicines Agency is concerned about the increasing levels of resistance to antibiotics in humans and animals and is engaged in a number of initiatives aiming to tackle this problem.

In the field of antibiotics, the Agency's main role is to evaluate applications for the authorisation of antibiotic medicines, both for humans and for animals, and to ensure that they are used in areas where they bring the most benefit and the risk for the potential development of antimicrobial resistance is low.

In 2013, the Agency has contributed to the European Commission's Action plan against the rising threats from antimicrobial resistance, as well as global initiatives to combat antibiotic resistance, such as the Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR). In addition, among others, the following specific activities were undertaken:

• in May, the Agency published its Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 1 (first version) for public consultation. This draft guideline provides detailed recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for veterinary antimicrobial products. The period of public consultation for this guideline ends on 30 November 2013;
• in July, the Agency provided advice to the European Commission (EC) on the Answer to the first request from the European Commission for scientific advice on the impact on public health and animal health of the use of antibiotics in animals. This is the first response to a series of four questions raised by the EC in a request to the Agency related to the use of antimicrobials in animals and the potential impact of this use on human health and animal health;
• in October, the Agency published its Sales of veterinary antimicrobial agents in 25 European Union / European Economic Area countries in 2011 - Third European Surveillance of Veterinary Antimicrobial Consumption report. A total of 25 European Union (EU) and European Economic Area (EEA) countries submitted data on 2011 sales to the Agency. The 2013 report, as well as the reports from 2012 and 2011, will be used by risk assessors and risk managers in Member States to inform antimicrobial policy and the responsible use of antimicrobials;
• in November, the Agency published an Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. One of the most important aspects of the addendum is that it outlines a new approach facilitating the development of antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options. It also gives guidance on data-gathering strategies to support the benefit-risk evaluation as part of the marketing-authorisation process for different indications. The addendum complements the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 2;
• in November, the Agency, in collaboration with the EC, also hosted a workshop entitled 'Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem'. The aim of the workshop was to discuss regulatory options for approval of new antibacterials for human use and actions to increase appropriate use of antibiotics. Presentations from the workshop can be viewed by selecting the 'Documents' tab. Conclusions from the workshop are due for publication in late 2013;
• throughout the year, the CVMP – with the support of its Antimicrobials Working Party and in line with its CVMP strategy on antimicrobials 2011-2015, has strengthened its contribution to minimising the risk of development of antimicrobial resistance arising from the use of antibiotics in animals both within the EU and at an international level, and has, for example, published a Draft reflection paper on the risk of antimicrobial resistance transfer from companion animals and a revised Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health.