1. Key Strategies for Improving Use of Existing and New Antibiotics -the European Experience Otto Cars Professor Inf. Diseases, Uppsala University, Sweden Chairman, ReAct – Action on Antibiotic Resistance www.reactgroup.org

2. What is the European Union? 27 Member States 23 official languages > 500 million inhabitants (per country: 416,333 – 81.7 million) €25,100 GDP/capita (per country : 10,400 – 69,300) A patchwork of cultures! 1 € = 0.88 £ = 1.43 US$

3. No data No awareness No priority No funding Antibiotic Resistance - the vicious circle

4. Key Strategies for Improving Use of Existing and New Antibiotics -the European Experience Data Awareness National coordination Interventions

5. Klebsiella pneumoniae : proportion of multidrug*-resistant invasive isolates resistant, 2010 Source: EARS-Net, 2011. *Resistant to third-generation cephalosporins, fluoroquinolones and aminoglycosides European Antibiotic Resistance Surveillance: EARS-net

6. Source: European Surveillance of Antimicrobial Consumption (ESAC). Outpatient antibiotic (J01) use, by antibiotic class according to ATC classification, 2009 Cyprus and Lithuania: total use, i.e. including inpatients. Spain: reimbursement data, i.e. not including over-the-counter sales without a prescription, UK Czech Rep. Source: ESAC, 2011. European Surveillance of Antibiotic Consumption (ESAC)

7. Human burden Economic burden Burden of multidrug-resistant (MDR) bacteria in the EU, Iceland and Norway Infections (6 most frequent MDR bacteria, 4 main types of infection) approx. 400,000 / year Attributable deaths approx. 25,000 / year Extra hospital days approx. 2.5 million / year Extra in-hospital costs approx. € 900 million / year Productivity losses approx. € 600 million / year So Limitation: these are underestimates Source: ECDC, 2009. In:http://ecdc.europa.eu/en/publications/Publications/0909_TER_The_Bacterial_ Challenge_Time to_React.pdf

8. 18 November 2011 http://antibiotic.ecdc.europa.eu

9. Images from national campaigns on prudent use of antibiotics

10. Council Recommendation on the prudent use of antimicrobial agents, 2001 Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (2002/77/EC) Photo: Stuart Chalmers, CC-BY

11. Implementation of National Intersectoral Coordination Mechanisms on AMR Adapted from: European Commission, Directorate - General Health and Consumers, 2010. http://ec.europa.eu/health/antimicrobial_resistance/key_documents/index_en.htm As of 2008, 18 EU Member States and Norway had implemented an Intersectoral Coordination Mechanism

12. Antibiotic presciptions/1000 in different age groups in Sweden

13. http://www.ameli.fr/fileadmin/user_upload/documents/DP_Antibiotiques_10-01-2008.pdf Antibiotic Use by Age Group in France

14. France Belgium Source: French Nat. Ref. Ctr. for S. pneumoniae (Courtesy: E. Varon, L. Gutmann & B. Schlemmer) & Belgian Nat. Ref. Ctrs. for S. pneumoniae and for S. pyogenes (Courtesy: BAPCOC, H. Goossens) Decreases in antimicrobial resistance following national media campaigns

15. Cathegory Community aqcuired? Hospital acquired? Surgical prophylaxis? Specific indication Septicemia? Pneumonia? Wound infection? UTI?

16. Changing prescribing pattern in pneumonia through real time feedback (DDD defined daily dosages) Implementation of SAI A user friendly system coupling prescriptions to diagnosis in hospitals

17. We are facing a public health threat Antibiotic Resistance Drug Development Morbidity Mortality Costs

18. Is there a need to change the present market system ? YES !

19. Innovative Incentives for Effective Antibacterials A conference during the Swedish Presidency of the EU 2009 focusing on the need to reinvigorate research and development of new antibiotics Governments Academia Pharmacuetical and biotech industry Civil society

21. Justifies intervention from the public sector Urgent need for new antibiotics Market failure Impending health crisis High health and economic burden from resistance

22. New collaborative models needed Urgent need for new antibiotics The overall innovative capacity is low There are major scientific challenges Who is going to do the work? Big Pharma? Small pharma? Academia?

23. But we cannot keep (mis)using them the way we have for the last 70 years! Marketing and use needs to be restricted De-linking return of investment from sales ! We need a new business logic! Urgent need for new antibiotics

24. From the EU Commission Action Plan on Antimicrobial Resistance launched TODAY in Brussels

25. Adapted from Källander, 2005 Access Excess A new business model must be built on the global needs and secure access and affordability as well as rational use