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. This addendum was released for public consultation in July 2012:
- 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 CVMP's Efficacy Working Party published a concept paper for consultation in April 2011, which addresses the need to update the current guideline on efficacy:
- Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances.
- Concept paper on the revision of the CVMP 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, establishing a working group made up of experts from both committees, the CVMP Antimicrobials Working Party and the CHMP Infectious Diseases Working Party. The group will have input from ECDC and EFSA, and will seek the views of other stakeholders as relevant topics when formulating its advice.
The advice will be delivered in a step-wise manner, with the first outcome requested by June 2013 and finalisation expected for the end of 2014.
In 2009, the Agency published two reports together with other European bodies, including ECDC, the European Food Safety Authority (EFSA) and the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the risk of antimicrobial resistance spreading from animals to humans.
These reports 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
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