Annexes to COM(2011)748 - Action plan against the rising threats from Antimicrobial Resistance - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)748 - Action plan against the rising threats from Antimicrobial Resistance. |
|---|---|
| document | COM(2011)748  |
| date | November 15, 2011 |
- This action will be complemented by the reinforced action to ensure prudent use as well as international collaboration aimed at combating transfer of resistance.
Development of veterinary antimicrobials
The development of antimicrobials for potential use in animals has been hampered, particularly in view of the uncertainty as to whether new antimicrobials or even new indications for such active substances would be given a marketing authorisation for the veterinary sector.
Development of diagnostic tools in human and veterinary medicine
Diagnostic tools that include tests for quick and accurate identification of pathogenic micro-organisms and/or for determining their sensitivity to antimicrobials play a key role in the fight against microbial infections. Research on the development of such tools as well as their implementation in health care is funded under FP7 and additional efforts are expected to be funded under the forthcoming research and innovation programme 2014-2020 (Horizon 2020).
Development of vaccines and other preventive measures
Vaccines and other preventive measures could have an important impact on reducing the spread of infections and, thus, the need for treatment. Therefore, research and innovation in this field should be supported.
Action n° 7: Promote efforts to analyse the need for new antibiotics into veterinary medicine Establishing request for scientific advice to clarify in particular whether the development of new veterinary antimicrobials would reduce AMR. Evaluation of the need and possible introduction of incentives that trigger development in veterinary medicines to increase the likelihood that innovations reach the market within the review of the rules on veterinary medicines foreseen in 2013. |
Joining forces with international partners to contain the risks of spreading AMR from international trade and travel and via the environment
- In view of the global nature of AMR, the EU has already worked actively in several international fora, which aim to expand global awareness and joint measures. The Commission will continue to support this work, e.g. to encourage other WHO regions to take into account the approach of the WHO's European region, to ensure continuous consistency with work of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance, to further contribute to the development of Health Codes by the World Organisation for Animal Health (OIE), to play an active role in the Codex Alimentarius, and to continue to encourage trading partners to consider their own measures against AMR.
In addition, the EU aims at developing bilateral cooperation against AMR. The EU started a bilateral cooperation with the USA on AMR as a request of the EU-US summit 2009. In 2011 the EU-US Transatlantic taskforce (TATFAR) has identified 17 key recommendations for strengthened cooperation in 3 key areas: 1) Appropriate therapeutic use of antimicrobials in human and veterinary medicines, 2) Prevention of drug-resistant infections and 3) Strategies for improving the pipeline of new antibiotics. The TAFTAR recommendations for concrete future collaboration on these key areas are consistent with the priorities in this action plan.
Action n° 8: Develop and/or strengthen multilateral and bilateral commitments for the prevention and control of AMR in all sectors. Multilateral cooperation Cooperate with WHO EURO in implementing the new Regional Strategies against AMR and Multi Drug Resistant tuberculosis across the WHO EURO Region. Contribute to further development of the Health Codes of the OIE and promote the implementation of Codex Alimentarius internationals standards on AMR. Initiate cooperation on reduction of the environmental pollution by antimicrobial medicines particularly from production facilities. Bilateral cooperation Strive to maintain and deepen transatlantic cooperation against AMR through active participation in the TATFAR and the implementation of its recommendations. Set out and apply in a staged approach a plan to implement the 17 recommendations of TATFAR. |
OTHER HORIZONTAL ACTIONS
- In addition to above key actions, some other measures should be taken, including monitoring, research, communication and education/training.
Monitoring and surveillance
Surveillance of AMR and antimicrobial consumption in human medicine
EU surveillance systems have been developed to monitor AMR (European Antimicrobial Resistance Surveillance Network) and the consumption of antimicrobials (European Surveillance of Antimicrobial Consumption, ESAC). These systems provide key information and data supporting the prevention and control of AMR. In addition, while young children are the main recipients of antibiotics in the EU, there is currently only very limited surveillance data on antimicrobial consumption and antibiotic resistance for children in Europe.
Action n° 9: Strengthen surveillance systems on AMR and antimicrobial consumption in human medicine With the support of the ECDC, assess ways to improve access to data on AMR at all levels (regional, local and hospitals). Ensure the efficient transfer of the ESAC project to ECDC to secure the sustainability of the project. With the support of the ECDC, support and monitor the successful development of the new EU funded surveillance project ARPEC – Antibiotic Resistance and Prescribing in European Children. |
Surveillance of AMR and antimicrobial consumption in animals
- AMR monitoring is mandatory for most important zoonotic bacteria in food producing animals. These bacteria (e.g. Salmonella, E. coli ) may infect humans directly or through the consumption of food and jeopardize antimicrobial treatment in humans. Based on recent EFSA recommendations, the Commission will propose updating of the monitoring requirements. Data on usage of antimicrobials both in humans and in animals is needed for risk profiling, risk assessment and research purposes as well as for setting risk management goals and evaluating their effectiveness.
Harmonisation of resistance monitoring for human, animal, environment and food bacteria favours the comparability of the monitoring results and consequently provides better input for the risk assessment and risk management activities. In addition, the access to data and information on AMR and use of antimicrobials must be enabled and improved for decision makers, professionals and the public.
Action n° 10: Strengthen surveillance systems on AMR and antimicrobial consumption in animal medicine Inclusion of a legal basis for the monitoring of AMR in animal pathogens in its forthcoming proposal for a new Animal Health Law. Promotion and extension of the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) with the collaboration of EMA to obtain harmonised data on the usage per animal species and production categories as well as for different indications from all Member States. Review of the monitoring of AMR in zoonotic bacteria and/or indicators. With the support of the relevant EU agencies, establish harmonisation between human and veterinary surveillance to allow comparison of data. |
Additional Research and Innovation
- Scientific research and innovation serves as a basis for science-based policy and legal measures to combat AMR and can provide new tools for diagnosis and treatment. Diagnostic tools that include tests for quick and accurate identification of pathogenic micro-organisms and/or for determining their sensitivity to antimicrobials play a key role in the fight against microbial infections. Vaccines and other preventive measures could have an important impact on reducing the spread of infections and, thus, the need for treatment. Therefore, research and innovation in these fields should be supported.
The FP7 funds a multitude of collaborative research projects aimed at improving the understanding of resistance mechanisms, as well as projects that stimulate academia and small and medium sized enterprises to work together towards novel innovative solutions for diagnostic tests and to combat the spread of AMR.
Action n° 11: Reinforce and co-ordinate research efforts, in particular Promote further research aiming at better understanding of antimicrobial resistance and pathogenic-host interactions. Promote further research on the development of diagnostic tools, vaccins and other preventive measures. Support the launch of a Joint Programming Initiative[13] aimed at coordinating national research activities related to AMR. Support an analysis of the reasons for high usage of antimicrobials in countries with the highest occurrence of AMR in the human sector. Contribute to a global mapping of drug resistance. |
Communication, education and training
- With more than 50% of EU citizens still believing that antibiotics are effective against viruses, awareness and understanding of the public in general and healthcare, veterinary and other professionals on AMR and the importance of appropriate use need to be enhanced through education campaigns throughout the EU and by making AMR a more integral part of education programs for health and veterinary professional groups. The "European Antibiotics Awareness Day" (EAAD) – an annual European public health initiative taking place on 18 November to raise awareness about the threat to public health of antibiotic resistance and about prudent antibiotic use – provides a unique platform to support the dissemination of information and key messages on this issue. With more than 35 Member States and international partners having developed campaigns and events in 2011 as part of the EAAD, this initiative should be maintained and strengthened.
This communication effort should be supported by effectiveness research to improve and maximise the impact of these campaigns on practitioners and the general public.
Action n° 12: Survey and comparative effectiveness research Building up on the findings of the 2010 AMR Eurobarometer survey, the Commission will by no later than 2015 conduct a new EU wide survey: Assessing the impact of the national and EU awareness campaigns on AMR including the development of indicators. Monitoring the evolution of the behaviour of the general public with regard to AMR and the appropriate use of antimicrobials. support improving the effectiveness and the impact of these campaigns among others through the identification of target groups and most efficient communication practices and the exchange of best practices. |
EX-POST EVALUATION
- In order to evaluate and assess the trends, the impact and effectiveness of the measures taken and the goals achieved by the implementation of the 5-year action plan to fight against AMR, the Commission shall monitor the use of antibiotics and antimicrobial resistance, and, where appropriate, shall ask follow up reports on the implementation and actions taken at national level.
CONCLUSIONS
The increasing resistance to antimicrobial drugs represents one of the major emerging threats to human health. To address this, a holistic approach is stressed in line with the "One Health" initiative.
The Commission proposes to put in place a 5-year Action Plan to fight against AMR based on 12 key actions:
( Action n° 1: Strengthen the promotion of the appropriate use of antimicrobials in all Member States.
( Action n° 2: Strengthen the regulatory framework on veterinary medicines and on medicated feed.
( Action n° 3: Introduce recommendations for prudent use in veterinary medicine, including follow-up reports.
( Action n° 4: Strengthen infection prevention and control in healthcare settings.
( Action n° 5: Introduce of a legal tool to enhance prevention and control of infections in animals in the new Animal Health Law.
( Action n° 6: Promote, in a staged approach, unprecedented collaborative research and development efforts to bring new antimicrobials to patients.
( Action n° 7: Promote efforts to analyse the need for new antibiotics into veterinary medicine.
( Action n° 8: Develop and/or strengthen multilateral and bilateral commitments for the prevention and control of AMR in all sectors.
( Action n° 9: Strengthen surveillance systems on AMR and antimicrobial consumption in human medicine.
( Action n° 10: Strengthen surveillance systems on AMR and antimicrobial consumption in animal medicine.
( Action n° 11: Reinforce and co-ordinate research efforts.
( Action n° 12: Survey and comparative effectiveness research.
Several Member States have been pro-active in carrying out actions related to those considered at EU level. These actions at national level and the experience gained from it should be the basis of the practical development and implementation of this Action Plan.
[1] ECDC/EMEA JOINT TECHNICAL REPORT The bacterial challenge: time to react. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.pdf
[2] COM/2001/0333 final Volume I.
[3] http://ec.europa.eu/research
[4] http://www.one-health.eu
[5] Council Recommendation (2002/77/EC) of 15 November 2001 on the prudent use of antimicrobial agents in human medicine, OJ L 34, 5.2.2002, p. 13-16.
[6] http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_n_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
[7] Scientific Opinion on the public health risks of bacterial strains producing extended-spectrum β-lactamases and/or AmpC β-lactamases in food and food-producing animals. EFSA Journal 2011;9(8):2322. [95 pp.]. Available online: www.efsa.europa.eu/efsajournal
[8] Joint scientific report of ECDC, EFSA and EMEA on meticillin resistant Staphylococcus aureus (MRSA) in livestock, companion animals and foods. EFSA-Q-2009-00612 (EFSA Scientific Report (2009) 301, 1-10) and EMEA/CVMP/SAGAM/62464/2009. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/10/WC500004306.pdf
[9] Council Recommendation (2009/C 151/01) of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections, OJ C 151, 3.7.2009, p. 1–6.
[10] ECDC/EMEA JOINT TECHNICAL REPORT The bacterial challenge: time to react. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.pdf
[11] http://ec.europa.eu/research/health/infectious-diseases/antimicrobial-drug-resistance/index_en.html
[12] European Federation of Pharmaceutical Industries and Associations.
[13] http://www.consilium.europa.eu/uedocs/cms_Data/docs/pressdata/en/intm/118029.pdf