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Lucie Pokludová Institute for State Control of Veterinary Biologicals and Medicines

ANTIMICROBIAL RESISTANCE How to tackle an issue in the new legislative for veterinary medicinal products. Lucie Pokludová Institute for State Control of Veterinary Biologicals and Medicines Czech Republic EPP Group Public Hearing , Brussells , 22.4.2015.

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Lucie Pokludová Institute for State Control of Veterinary Biologicals and Medicines

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  1. ANTIMICROBIAL RESISTANCEHow to tackle an issue in the new legislative for veterinary medicinal products Lucie Pokludová Institute forStateControlofVeterinaryBiologicals and Medicines Czech Republic EPP Group Public Hearing, Brussells, 22.4.2015

  2. Main motivations to adopt new rules for VMPs • Improve availability, in particular for „limited markets“ • Reduce administrative burden for the veterinary pharmaceutical companies • Enhance innovation in veterinary medicine • Strengthen internal market …while not reducing the quality, safety and efficacy standards for veterinary medicinal products

  3. Antimicrobial resistance:Two pillars

  4. Example from practice: Dairy cows: ceftiofur(newer, last resort) x amoxicillin(older, first choice) AMR: Prudent use warnings Economy: Withdrawal period Ceftiofur: Milk: zerodays MRL : milk: 100 µg/ kg Amoxicillin: Milk: max9 days (differsacrossVMPs) MRL : milk: 4 µg/ kg Ceftiofur: • „Ceftiofur VMP“ selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) => a risk to human health if these strains disseminate to humans. Thereforeshould be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis), to more narrow spectrum ATMs first line treatment. • Official, national and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of resistance to ceftiofur. • Whenever possible „ceftiofur VMP“ should only be used based on susceptibility testing. • Do not use as prophylaxis in case of retained placenta. • „Ceftiofur VMP“ isintended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly limited to ongoing disease outbreaks according to the approved conditions of use. Amoxicillin: ATM to be used based on susceptibility testing or knowledge of epidemiological situation in the herd.

  5. Antimicrobial resistance:Responsibilities & Stakeholders

  6. Antimicrobial resistance:Risk assessment : Risk management RA RM

  7. How we are going to use the new Regulation in practice in terms of AMR ? • Definition of antimicrobial resistance in the COM draft • based on wild type resistance pattern • ECOFF values to be used as benchmark for regulatory actions • What do we want to achieve by the new Regulation • Do we want to use ECOFFs for resistance assessment • Do we want to use the same criteria for VMPs evaluation in case of animal health, public health and the environment • What impact will be on innovations / new products development • COM draft does not indicate the goals to be achieved / brings uncertainty … We need to define clearly how the benefit : risk will be assessed for antimicrobial VMPs

  8. AMR in the new regulation on VMPsMarketing authorisation

  9. AMR in the new regulation on VMPsPost authorisation / Continuous benefit:risk

  10. AMR in the new regulation on VMPsUse of VMPs

  11. What is missing in the new legislation

  12. Main concerns: • The new Regulation on VMPs as proposed by COM would lead to deterioration of Quality/Safety/Efficacy standards for VMPs with a direct negative impact on AMR. • Main gaps identified as for: • Variations • SPC harmonisation • Reduced pharmacovigilance • MRP/DCP • Post-marketing – in consequence to MA : NOT in line with „One Health“ Concept • Proper balance is missing in terms of internal market and animal/public health/environmental protection

  13. QSE of VMPs VMPs lifecycle Innovation of VMPs One Health / Responsible use of VMPs / Preventive veterinary medicine / Good animal husbandry practices Restrictions

  14. Thank you for your attention ! Questions/ comments are welcomed ! pokludova@uskvbl.cz

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