Antimicrobials are medicines that kill or inactivate microbes, small disease-causing organisms. They include antibiotics, which are used against bacteria. After being exposed to an antimicrobial repeatedly, microbes can undergo changes that stop them being killed or inactivated by the treatments. This is known as antimicrobial resistance.
The European Medicines Agency is concerned about the development of antimicrobial resistance, particularly resistance to antibiotics. 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).
This problem is being made worse by the fact that few new antimicrobials have been authorised over the past few years. This may lead to infections becoming more difficult to treat in the future.
Antimicrobial resistance is a growing problem in humans and in animals. Resistance can also spread from animals to humans through the food chain or direct contact.
The role of the Agency
The Agency works in collaboration with its EU and international partners in a number of initiatives aiming to limit the development of resistance. It is also monitoring and evaluating the risks to human and animal health.
A major such initiative is the Transatlantic Task Force on Antimicrobial Resistance (TATFAR), which was established following the EU-United States summit in November 2009. The Task Force aims to increase levels of communication, coordination and co-operation between the EU and the United States on human and veterinary antimicrobials.
In human medicine, the availability of medicines to treat infections with resistant organisms has become a major problem in recent years.
In September 2009, the Agency published a joint report together with the European Centre for Disease Prevention and Control (ECDC) and the international network ReAct - Action on Antibiotic Resistance. This report highlights the gap between infections due to resistant bacteria and the development of new antibiotics.
The report states that at least 25,000 patients in the EU die each year from infections due to bacteria that are resistant to many medicines, and that infections due to these bacteria in the EU result in extra healthcare costs and productivity losses of at least €1.5 billion each year. Although it identified 15 antibiotics under development, most of these were early in development and were targeted against bacteria for which treatment options were already available.
Authorisation of new antibiotics
The Agency plays a key role in the authorisation 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, on the recommendation of the Agency.
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:
This is accompanied by an addendum giving information on how to study medicines for specific indications. The final addendum was published in November 2013 following a public consultation:
- Addendum on the note for guidance on the evaluation of medicinal products indicated for treatment of bacterial infections
The Agency is focused on promoting the prudent use of antimicrobials in animals, to limit the development of resistance. This goal is addressed in this document:
In line with this strategy, the Agency published a revised version of its guideline on efficacy for public consultation in May 2013. This draft guideline provides detailed recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for antimicrobial veterinary products:
- Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances
Since early 2010, the Agency has been leading a project collecting information on the sale of veterinary antimicrobials across the EU:
The CVMP has also published a large number of documents on microbial resistance in animals and its risks for humans.
Transmission of resistance from animals to humans
In April 2013, the European Commission requested advice from the Agency on the impact of the use of antibiotics in animals on public and animal health and measures to manage the possible risk to humans. This forms part of its action plan against the rising threats from antimicrobial resistance:
- European Commission request for advice on the impact on public health and animal health of the use of antibiotics in animals
The CVMP and the Committee for Medicinal Products for Human Use (CHMP) are working together on providing this advice and have established a working group made up of experts from both committees, the CVMP Antimicrobials Working Party and the CHMP Infectious Diseases Working Party. The group receives input from ECDC and the European Food Safety Authority (EFSA), and seeks the views of other stakeholders as relevant when formulating its advice.
The advice is being delivered in a step-wise manner, with finalisation expected for the end of 2014.
The first response was publshed in July 2013 and includes advice from the Agency on the use of colistin and tigecycline in animals:
- 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
- Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health
- Use of glycylcyclines in animals in the European Union: development of resistance and possible impact on human and animal health
Previously, reports published by the Agency together with other European bodies, including ECDC, EFSA and the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) emphasised the need for the prudent use of antibiotics in animals and the role of basic hygiene, and called for strengthened surveillance of resistance, the development of new antimicrobials and new strategies to combat the spread of resistance:
- Joint scientific report of ECDC, EFSA and the European Medicines Agency on MRSA in livestock, companion animals and food
- Joint opinion on antimicrobial resistance focused on zoonotic infections
In order to give stakeholders the opportunity to provide information, data and/or views on the request from the European Commission, the EMA is conducting a consultation exercise as a part of the preparation of its advice, through a consultation meeting with stakeholders to be held on 28 February 2014. The three objectives of the meeting are to:
- explain in detail the approach to the consultation and the timetable that the Antimicrobial Advice ad hoc Expert Group (AMEG) will follow in preparing its responses;
- indicate those areas where the AMEG is seeking additional information from stakeholders in order to prepare draft responses;
- provide an opportunity for questions-and-answers on how stakeholders can best provide input.
The procedure for stakeholder input on questions 2-4 is detailed in the consultation document.