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Brussels, 16 November 2012
European Antibiotic Awareness Day 2012: Key Facts on the Fight Against Antimicrobial Resistance (AMR)
The European Antibiotic Awareness Day is an annual European public health initiative that takes place on 18 November. Ahead of this event, the European Centre for Disease Control (ECDC) today released the latest data on antibiotic resistance and consumption in the European Union and European Economic Area. In the past four years there has been a significant increasing trend of combined resistance to multiple antibiotics in both Klebsiella pneumoniae and E. coli in more than one-third of EU/EEA countries. Furthermore, the ECDC data showed that consumption of carbapenems – a major last-line class of antibiotics – increased significantly in EU/EEA countries from 2007 to 2010. Three countries (Iceland, Latvia and United Kingdom) had growth in antibiotic consumption of more than 5% between 2009 and 2010; while, during the same period, consumption fell in three other countries (Austria, Lithuania and Poland).
What is the Commission's current strategy on AMR?
The Commission takes a holistic approach to the problem, as set out in its 17 November 2011 Communication on antimicrobial resistance (AMR). This action plan includes 12 key actions involving many different sectors: human medicine, veterinary medicine, research, animal husbandry, agriculture, environment, trade and communication. It aims, over a period of five years, to substantially reinforce existing good practice and to introduce a new set of rigorous measures to prevent the further spread of resistance and preserve the ability to combat microbial infections. See IP/11/1359.
What has already been achieved?
In the areas of human medicine and health, several EU-wide recommendations and guidelines against AMR have been adopted in the past decade. For example, 26 countries have implemented actions to prevent and control healthcare associated infections (HAI), in most cases in the context of a national/regional strategy and/or action plan1. In the areas of veterinary medicine and animal health, the Commission has adopted a Decision on the prudent use of veterinary antimicrobials belonging to the class of 3rd and 4th generation cephalosporins (considered as critically important by the WHO and the OIE). In animal husbandry, a ban on the use of antimicrobials for growth promotion was introduced in 2006. A reflection process on EU Guidance on prudent use of antimicrobials in veterinary medicine in underway.
What about research?
The European Commission has devoted some €1 billion into AMR-related research, including drug projects. This includes three coordinated calls for project proposals with strong emphasis on antimicrobial resistance2 published in July. They will result in new investment of up to €147 million into research projects to use existing antimicrobials more efficiently, to bring new antibiotics to patients, and to improve diagnostics to aid prescription. In addition, the Innovative Medicines Initiative (IMI) - Europe's largest public-private partnership to bring better medicines to patients – in June announced up to €224 million in funding for projects to develop new antibiotics: €115 million via "in kind" contributions from companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA), plus EU funding worth €109 million to bring other essential partners - such as patient associations, universities, SMEs, hospitals and regulatory authorities – into the research and development work. A new IMI call for proposals is due to be published in the coming weeks with the aim of expanding this programme to include additional clinical studies and the development of drugs against particularly dangerous gram-negative infections. Lastly, the Commission is supporting Member States' efforts to co-ordinate national research activities on AMR under the Joint Programming Initiative "The Microbial Challenge – An Emerging Threat to Human Health" which has taken up operations in early 2012. The final research agenda, expected to be ready in 2013, will be the starting point for new joint projects and initiatives.
How is AMR monitored in the EU?
The Commission works closely with the main relevant EU executive agencies (see below) Laws calling for the monitoring of zoonotic AMR (resistance transmissible between animals and humans) with a focus on monitoring the use of antimicrobials in animals, are in place. At the request of the Commission, the European Food Safety Agency has published two scientific opinions on how to improve and reinforce the EU surveillance systems on AMR in animals and food. These opinions form the basis of an on-going discussion on a new legislative framework for the EU monitoring of AMR.
What about international cooperation?
The European Commission and its agencies (EMA, EFSA and ECDC) are involved in international cooperation to address AMR, particularly with the United States via the trans-Atlantic taskforce on antimicrobial resistance (TATFAR). Instigated in 2009, the task force's objectives are to increase the mutual understanding activities and programmes relevant to AMR issues, to provide opportunities to learn from each other, and to promote information exchange, coordination and co-operation.
What is the role of the executive agencies in the fight against AMR?
The European Centre for Disease Prevention and Control (ECDC) collects and analyses and collects data on the occurrence and spread of AMR in EU/EEA countries, and publishes a report with the latest figures every November. In addition, since 1 July 2011, ECDC coordinates the European Surveillance of Antimicrobial Consumption Network (ESAC-Net) that collects and analyses data on human antibiotic consumption from EU/EEA countries, both in the community and in the hospital sector. Each year since 2008, ECDC coordinates the European Antibiotic Awareness Day (EAAD) on 18 November. More information on ECDC’s role in AMR can be found here and here.
The European Medicines Agency (EMA) works with its EU and international partners in a number of initiatives aiming to limit the development of antimicrobial resistance. It also monitors and evaluates the risks to human and animal health. The Agency plays a key role in the assessment of new antibiotics, because medicines with a significant therapeutic innovation or that are in the interest of public or animal health are authorised centrally in the EU. EMA's second ESVAC Report published this year, includes data on the consumption and sales of veterinary antimicrobials in 2010 in 19 Member states, and reveals for example that there is a 30-fold difference between sales of veterinary antimicrobial agents between the most and least-selling countries. In January 2012, the Agency updated its guidance to companies developing antibiotics, covering how they should carry out studies to test these medicines' benefits and risks. More information on EMA’s role in AMR here.
The European Food Safety Authority (EFSA) provides independent scientific support and advice to risk managers on the risks to human and animal health related to the possible emergence, spread and transfer of antimicrobial resistance in the food chain and in animal populations. EFSA takes an integrated approach to its work on antimicrobial resistance involving a number of its Scientific Panels and Units as it is a concern for the entire food chain. In its work, EFSA cooperates closely with other relevant EU agencies such ECDC and EMA. More information on EFSA’s role in AMR here
For Further Information:
Innovative Medicines Initiative:
Commission report on the implementation of the Council Recommendation (2009/C 151/01) adopted in November 2012.
Under the specific work programmes "Health", "Knowledge Based Bio-Economy" and "Nanosciences, Nanotechnologies, Materials and new Production Technologies"