The emerging and steady increase of microbes that are resistant to antimicrobial treatments has become a global public health concern that threatens the effective treatment of infectious diseases. Combatting this threat, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network.
Antimicrobial resistance is when a microbe evolves to become more or fully resistant to antimicrobials which previously could treat it. Antimcirobials include antibiotics, which kill or inhibit the growth of bacteria.
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A well-known example of a bacterium that is resistant to a number of antibiotics is meticillin-resistant Staphylococcus aureus (MRSA), which has caused infections that are difficult to treat across the European Union (EU).
Infections by multidrug-resistant bacteria are estimated to cause 25,000 deaths in the EU every year. Amtimicrobial resistance also places a tremendous burden on healthcare systems and society, with an annual cost due to healthcare expenditures and productivity losses estimated at approximately €1.5 billion in the EU.
Although the development of resistance occurs naturally when microorganisms replicate themselves erroneously or when resistant traits are exchanged between them, the use and misuse of antimicrobials accelerates the emergence of resistant strains.
The lack of new antibiotics entering the market exacerbates the problem.
Antimicrobial resistance affects both humans and animals and resistance can also spread from animals to humans through the food chain or direct contact.
EMA plays a vital role in the global response to the threat of antimicrobial resistance, by:
- supporting the development of new medicines and treatment approaches;
- promoting responsible use of existing antibiotics;
- collecting antimicrobial consumption data to guide policy and research.
EMA supports a 'One Health' approach, promoting a close and integrated cooperation between the human and veterinary fields. For more information on the Agency's work in each sector, see:
EMA Executive Director, Prof. Guido Rasi on how to tackle antimicrobial resistance
EMA supports the European Commission's action plan against the rising threats from antimicrobial resistance, by providing scientific input and recommendations on the use of antibiotics in animals, in partnership with other relevant EU bodies, including the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA).
Update: On request of the European Commission, EMA, ECDC and EFSA are developing a list of harmonised outcome indicators to enable Member States to:
- monitor the use of antimicrobials in humans, food-producing animals and food;
- assess the progress made in implementing their action plans against antimicrobial resistance.
The agencies expect to publish the list of indicators in the second half of 2017.
For more information, see:
In January 2015, together with ECDC and EFSA, EMA published a joint integrated analysis of the consumption of antimicrobial agents and the occurrence of antibacterial resistance in humans and food-producing animals.
This was the first time that data from humans, animals and food in Europe were analysed together, providing valuable insights for policy-makers across the EU:
- ECDC/EFSA/EMA first joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals
In 2009, EMA published a joint report with the ECDC and the international network ReAct - Action on Antibiotic Resistance on the gap between infections due to resistant bacteria and the development of new antibiotics:
Antibiotic use and awareness
In June 2016, the European Commission published the results of a Eurobarometer survey on the use and perceptions of antibiotics in the EU.
The report shows a 6% decrease in antibiotic consumption in the EU in the last seven years. It also highlights a persistent lack of knowledge on the effect of antibiotics among Europeans.
To raise public awareness on antimicrobial resistance, the Dutch Ministry of Health, Welfare and Sport has published short animated online videos on its website.
Working with international partners
EMA hosted a tripartite meeting with he Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) in September 2016 to discuss regulatory approaches for the evaluation of antibacterial agents.
The agencies concluded that a comprehensive and multifaceted response is needed to encourage and accelerate development of new antibacterial medicines, and agreed to explore common regulatory approaches:
- Conclusions of meeting between EMA, FDA and PMDA on 1-2 September 2016 to discuss regulatory approaches for the evaluation of antibacterial agents
The EU and the United States (US) established the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) as a result of the 2009 US-EU summit to intensify cooperation in the fight against antimicrobial resistance. EMA is a member of TATFAR.
The taskforce aims to increase levels of communication, coordination and cooperation between the EU and the US on human and veterinary antimicrobials.
In October 2015, work started on a new work plan for the period up to 2020, including extending the membership to Canada and Norway.
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