1. EC actions against the rising threats from Antimicrobial Resistance
Workshop on Antimicrobial Resistance
Koen Van Dyck Head of Unit SANTE DDG2.G4: Food, Alert system and Training Directorate General Health & Food Safety (DG SANTE) European Commission
16-17 November 2015 – Brussels

2. According to data from 2011,  patients die annually as a result of infections caused by resistant bacteria in the EU. The costs incurred by drug resistant infections amount to an estimated €1.5 billion annually, due to increases in healthcare expenditure costs and productivity losses.

4. AMR is a major European and global societal problem
Decision-makers
Scientific advice
International organisations
Committees
CHVP
CVMP
ESVAC
Codex Alimentarius
Networks
EARS-Net
ESAC-Net
AMR impacts medicine, veterinary medicine, animal husbandry, agriculture, environment and trade
EMA
CHMP: Committee for Medicinal Products for Human Use
CVMP: Committee for Medicinal Products for Veterinary Use
ESVAC: European Surveillance of Veterinary Antimicrobial Consumption
ECDC
EARS-Net: Antimicrobial resistance interactive database
ESAC-Net: European Surveillance of Antimicrobial Consumption Network
SCENHIR: Scientific Committee On Emerging And Newly Identified Health Risks
Codex Alimentarius: Partof WHO & FAO activities, collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety
Scientific committees
SCENIHR
Regulations; Directives; EC communications / decisions; Council conclusions / resolutions / recommendations
Guidelines, technical reports, scientific advice, recommendations
Guidelines, reports

5. AMR a public health priority
Some actions taken so far:
Ban on the use of AM for growth promotion (2006)
Monitoring AMR and use of antimicrobials (EU agencies: EFSA, EMA, ECDC)
International activities (TATFAR, Codex, OIE)
Research
Scientific opinions, data on monitoring
Not enough, further action needed !
AMR is therefore a priority for the Commission. Over the past decade the Commission has developed a series of EU-wide policy and legislative initiatives for the control or prevention of AMR, both in the field of human medicine and in the veterinarian and food safety area:
Some examples of these initiatives in the veterinarian and food safety area are:
- In 2006 the Commission introduced the ban on the use of antimicrobials for growth promotors.
Focus has been done on the monitoring of antimicrobial resistance and the use of antimicrobials in animals.
International cooperation is essential. The Commission is working actively with international organisations such as Codex Alimentarius, OIE or WHO. All these organisations have developed guidelines aiming to control AMR attributed to the use of antimicrobials in animals. An EU/US Transatlantic task Force (TAFTAR) on AMR was notably set up in November 2009 to strengthen transatlantic cooperation against AMR. This task Force provided a first report in September 2011 identifying areas for further cooperation, both in human and veterinary medicines.
Research on AMR is a priority in the programs of DG RTD.
But although all the initiatives developed until now were in the right direction, they have not succeeded in containing the rising threat of AMR. Data collected in Europe and scientific opinions indicate that AMR remains a largely unresolved public health issue and that further actions are needed to combat AMR.
The Commission is determined to effectively address what is clearly one of the greatest challenges to global health. 5 5

6. AMR a public health priority!
COM (2011) 748 – 17 Nov 2011
5 year action plan
Holistic approach
7 key areas
12 concrete actions
Antimicrobial Resistance (AMR) is a serious, worldwide, public health concern for both humans and animals. According to data from 2009, patients in the EU die annually as a result of infections caused by resistant bacteria. The costs incurred by AMR amount to an estimated EUR 1.5 billion annually, due to loss of productivity and an increase in healthcare expenditure costs.
Antimicrobial resistance is therefore a priority for the Commission with initiatives developed over the past decades in both human and veterinary medicine.
To further strengthen its commitment, the Commission launched in November a 5 year Action Plan against Antimicrobial Resistance.
The Plan is based on a holistic approach involving all sectors and aspects of antimicrobial resistance (public health, animal health, food safety, consumer safety, research, non-therapeutic use of antimicrobials, etc.)

7. The 12 actions Human Veterinary 1. Appropriate use
4. Prevention of infections
6. New antibiotics
9. Surveillance
8. International cooperation
11. Research & Innovation
12. Communication, education
2 & 3. Appropriate use
5. Prevention of infections
7. Need for new antibiotics
10. Surveillance

8. A. Appropriate use of antimicrobials
Action nº1: Strengthen the promotion of the appropriate use of antimicrobials in human medicine in all Member States
Action nº2: Strengthen the regulatory framework on veterinary medicines and on medicated feed
Action nº3: Introduce recommendations for prudent use in veterinary medicine
Appropriate use of antimicrobials
Action n° 1: Strengthen the promotion of the appropriate use of antimicrobials in human medicines in all Member States.
ARNA Project will provide a study identifying the key factors that drive the sales and non-prudent use of antibiotics in human medicine obtained without medical prescription, assess the level of enforcement of the legal prescription-only requirement for antimicrobial agents in the EU and document best practices aimed at strengthening a more prudent use of antimicrobial agents
ARPEC Project identified the specific antibiotics used to treat common childhood infections in primary care in different Member States, specific antibiotics and doses to treat common infections in hospitals, and antimicrobial resistance patterns for the six key bacterial pathogens causing serious bacterial infection in children
Consultation with MSs on implementation (end 2015)
WORKSHOP:
Approval process of new antibacterials: existing regulatory framework was considered ‘fit for purpose’ further to development of the new guideline on evaluation of medicinal products indicated for treatment of bacterial infections
Existing tools to encourage the appropriate use of antibacterials: importance of enforcing of a ‘prescription only’ policy for antibacterials by the national competent authorities of the EU Member States was highlighted, process of harmonisation of Summary of Product Characteristics (SmPCs) was important, should continue and should be strengthened
Aspects related to research and development and new antibiotics: EU funding research with nearly 800 million Euro between 1999 and 2013 through its Framework Projects
Council Recommendation 2002/77/EC on the prudent use of antimicrobial agents in human medicine
AMR Strategy
Intersectoral implementation (by 2003)
Reliable data at regional, national and EU levels
Prescription only antibacterials (systemic)
Guidelines on infection control, diagnosis and use
Training
Controls on marketing
Hygiene and IC standards in hospitals, nursing homes and community
Research
A. Appropriate use of antimicrobials
Action n° 2: Strengthen the regulatory framework on veterinary medicines and on medicated feed
Revision of the Veterinary Medicines Legislation: New regulatory tools to EC & MSs to reduce the risks to human and animal health of the use of AM in animals
Scientific risk-benefit analysis for granting of marketing authorisations for veterinary antimicrobials,
the prudent use of antimicrobials,
a legal tool to preserve certain antimicrobials for human use and
a requirement to gather information on the use of veterinary antimicrobials
Revision of the Medicated Feed Legislation Medicated feed contains a premix of veterinary medicines and requires veterinary prescription. Sometimes, it is the most effective way for a farmer to give medicine to his livestock.
Provides a prohibition on the preventive use of antimicrobials included in medicated feed;
measures to increase the quality of medicated feed (more precise dosage) to avoid sub-therapeutic exposure and
establishes thresholds for residual levels of antimicrobials in ordinary compound feed
Bans on use of medicated feed; EU-wide residue limit for veterinary medicines in ordinary feed & stricter rules for medicated feed with AM

9. B. Prevent microbial infections & spread
Action nº4: Strengthen infection prevention and control in healthcare settings
Action nº5: Adoption of a proposal for an EU Animal Health Law
Appropriate use of antimicrobials
Action n° 1: Strengthen the promotion of the appropriate use of antimicrobials in human medicines in all Member States.
ARNA Project will provide a study identifying the key factors that drive the sales and non-prudent use of antibiotics in human medicine obtained without medical prescription, assess the level of enforcement of the legal prescription-only requirement for antimicrobial agents in the EU and document best practices aimed at strengthening a more prudent use of antimicrobial agents
ARPEC Project identified the specific antibiotics used to treat common childhood infections in primary care in different Member States, specific antibiotics and doses to treat common infections in hospitals, and antimicrobial resistance patterns for the six key bacterial pathogens causing serious bacterial infection in children
Consultation with MSs on implementation (end 2015)
WORKSHOP:
Approval process of new antibacterials: existing regulatory framework was considered ‘fit for purpose’ further to development of the new guideline on evaluation of medicinal products indicated for treatment of bacterial infections
Existing tools to encourage the appropriate use of antibacterials: importance of enforcing of a ‘prescription only’ policy for antibacterials by the national competent authorities of the EU Member States was highlighted, process of harmonisation of Summary of Product Characteristics (SmPCs) was important, should continue and should be strengthened
Aspects related to research and development and new antibiotics: EU funding research with nearly 800 million Euro between 1999 and 2013 through its Framework Projects
Council Recommendation 2002/77/EC on the prudent use of antimicrobial agents in human medicine
AMR Strategy
Intersectoral implementation (by 2003)
Reliable data at regional, national and EU levels
Prescription only antibacterials (systemic)
Guidelines on infection control, diagnosis and use
Training
Controls on marketing
Hygiene and IC standards in hospitals, nursing homes and community
Research
A. Appropriate use of antimicrobials
Action n° 2: Strengthen the regulatory framework on veterinary medicines and on medicated feed
Revision of the Veterinary Medicines Legislation: New regulatory tools to EC & MSs to reduce the risks to human and animal health of the use of AM in animals
Scientific risk-benefit analysis for granting of marketing authorisations for veterinary antimicrobials,
the prudent use of antimicrobials,
a legal tool to preserve certain antimicrobials for human use and
a requirement to gather information on the use of veterinary antimicrobials
Revision of the Medicated Feed Legislation Medicated feed contains a premix of veterinary medicines and requires veterinary prescription. Sometimes, it is the most effective way for a farmer to give medicine to his livestock.
Provides a prohibition on the preventive use of antimicrobials included in medicated feed;
measures to increase the quality of medicated feed (more precise dosage) to avoid sub-therapeutic exposure and
establishes thresholds for residual levels of antimicrobials in ordinary compound feed
Bans on use of medicated feed; EU-wide residue limit for veterinary medicines in ordinary feed & stricter rules for medicated feed with AM

10. C. Develop new effective AM or alternatives for treatment
Action nº6: Promote unprecedented collaborative research
Action nº7: Promote efforts to analyse need for new antibiotics into veterinary medicine
D. Join forces with international partners
Action nº8: Develop and / or strengthen multilateral and bilateral commitments for the prevention and control of AMR

11. E. Monitoring and surveillance
Action nº9: Strengthen surveillance systems on AMR and antimicrobial consumption in human medicine
Action nº10: Strengthen surveillance systems on AMR and antimicrobial consumption in animal medicine
F. Additional Research and Innovation
Action nº11: Reinforce and co-ordinate research efforts. Innovation.
G. Communication, education and training
Action nº12: Survey and comparative effectiveness research

12. Next steps Dedicated webpage AMR progress report
AMR progress report
AMR Roadmap
Ex-post evaluation (February 2016)

13. Concluding remarks
AMR remain a top priority for European Commission to lead at EU and work at global level
Ongoing evaluation of the EC Action Plan – basis to decide on the follow-up
Importance of concrete actions and implementation of the action plans by all stakeholders and Member States.

14. Thank you for your attention