1. University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Romania Since 1869 Anti-microbial resistance – Urgent need to act in human and veterinary medicine Wednesday, 22 April 2015 Dr. Mihai Cernea, DVM, PhD

2.  Anti-microbial resistance is a natural evolutionary process that can be slowed, but not stopped  Limited resources of the pharmaceutical industry and evolution of resistance outruns the progress of pharmaceutical research (8-12 years for a new medicine)  Bacteria have shown the ability to become resistant to every anti-microbial that has been developed for human or animals (on average after 1-9 years after introduction)  The more anti-microbial are used, the more quickly bacteria develop resistance  It is a worldwide and complex problem; can cross international boundaries and spread between continents, with potentially catastrophic consequences of inaction  Anti-microbial resistant infections add considerable costs to the healthcare system  Worldwide, anti-microbial are commonly used on feed for food animals to prevent, control and treat diseases, but in some countries, also to promote the growth Background of anti-microbial resistance

3. The current benefits of using anti-microbial in animal feed  Ensures the welfare of animals  Can be used for prevention or treatment  Reduces suffering and pain without causing additional stress (versus injection therapy)  Allows treatment of a large number of animals in a short period of time  Easy to use medicines for all species  Low cost compared with injectable treatments (price per animal treatment, the number of employees involved and time saved)

4. Risks and deficiences of using anti-microbial in animal feed  Homogeneity of drug in feed  Inevitable carry-over risk  Groups of animals treated with anti-microbial in feed are not (always) sufficiently homogeneous in terms of body weight  In a group, dominant animals will consume a greater amount of medicated feed  Sick animals consume a smaller amount of feed  underdosing  Healthy animals consume a larger amount of feed  overdosing  Using (sometimes) unjustified preventive medication in feed, instead of improving the hygiene conditions, nutrition, environmental conditions, management and biosecurity

5. Proposal for a Regulation of the European Parliament and of the European Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC New proposals for repealing Council Directive 90/167/EEC, are necessary and useful 1.From the legal standpoint, and the risk of resistance to anti-microbial and / or antiparasitic medication, including the risk of zoonotic diseases – should not be made any difference, between the methods of prevention or therapy in animals destined for human consumption or pet animals – except withdrawal time 2.Also, medicated feed should be considered as veterinary products, with all the ensuing implications (manufacture, labeling, quality control, storage, transport, record keeping, etc.) 3.Medicated feed (anti-microbial and antiparasitic) should be used in food-producing animals and pets only under veterinary supervision and with a prescription 4.Carry-out risk – the level established must be achievable by the all producers of medicated feed

6.  Anti-microbial and antiparasitic treatments in feed are required and can not be replaced in terms of animal welfare, therapeutic and economic efficiency  Preventive treatments using anti-microbials and antiparasitic administred in feed should be: prohibited, permitted or restricted ? Prevention versus treatment

7. Implications if their preventive use is prohibited :  animal welfare would be significantly affected  new facilities for the isolation of diseased animals  increase of the number of diseased animals treated with injectable therapeutic doses of anti-microbials  Increasing the amount and use of injectable antimicrobial products that are more expensive compared with those used in animal feed  increased morbidity, mortality and additional stress  lower economic efficiency - current systems of intensive livestock can not have economic efficiency without preventive treatments in feed Preventive treatments in feed ?

8. Implications if their preventive use is permitted :  animal welfare would not be affected for a period of time  easy to administer, without additional stress for animals, reduced number of employees involved, time saved  high economic efficiency  decrease of morbidity and mortality  risk of abusive use  animals do not necessarily require a better hygiene, nutrition, biosecurity and management Preventive treatments in feed ?

9. Implications if their preventive use is restricted :  animal welfare would not be affected  must be bound to the conditions that justify preventive treatments, could be, for example:  occurrence of bacterial and/or parasitic diseases  season-related illnesses (especially parasitic diseases) OR/AND  transport, regrouping and relocation of animals  weaning period  it is necessary to clearly specify which are the circumstances that allow the preventive use of anti-microbials and antiparasitic, otherwise there is the risk of abusive use  better hygiene, nutrition, biosecurity and management is needed Preventive treatments in feed ?

10. Expectation and core actions that will help fight against anti-microbials resistance  Preventing infections and preventing the spread of resistance by responsible use of anti-microbials and antiparasitic medication in humans and animals  Improving the use of today’s anti-microbials and antiparasitic and promoting the development of new ones  Developing new diagnostic tests for resistant bacteria or parasites (especially)

11.  It is necessary to implement a program of monitoring and surveillance of anti-microbials and antiparasitic resistance in all EU Member States, concerning incidence, prevalence, mortality, cost of resistance and data on medicines use in human and animal healthcare  Clear and mandatory programs to improve prescribing medicines in humans and animals - in order to greatly slow down the development and spread of anti-microbials and antiparasitic resistant infections  Better cooperation, education and communication (between pharmaceutical industry, veterinarians, producers, researchers, owners) at national, European and international level Expectation and core actions that will help fight against anti-microbials resistance

12. “No action today, no cure tomorrow” (World Health Organization) Mihai CERNEA, associate professor, DVM, PhD Pharmacology, Therapeutics & Management Department University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, Faculty of Veterinary Medicine Manastur street, no. 3-5, 400372 - Cluj-Napoca, Romania Phone: +40 264 596 384 / 186 Fax: +40 264 593 792 Mobile: +40 722 393 550 E-mail: mscernea@yahoo.com; mihai.cernea@usamvcluj.ro