European Union Lum py Skin Disease and other exotic diseases - PowerPoint PPT Presentation

European Union Lum py Skin Disease and other exotic diseases antigen/ vaccine banks Current status, policy and future considerations Stakeholder focus group m eeting on availability of Lum py Skin Disease ( LSD) vaccines authorised to EU standards European Medicines Agency (31 January 2017, London, UK) Andrea GAVINELLI – Dimitrios DILAVERIS European Commission Directorate-General for Health and Food Safety G3 – Official controls and eradication of diseases in animals

 EU Lum py Skin Disease ( LSD) vaccine bank • History • Structure - Operation • Vaccine grants todate  Other EU vaccine / antigen banks • Foot-and-Mouth Disease • Classical Sw ine Fever  General EU Policy on vaccine banks  Future trends on EU vaccine banks EMA - Stakeholder group on LSD vaccines (London, 31 January 2017)

EU LSD vaccine bank - History LSD in the EU: situation in 2 0 1 3 – 2 0 1 5 , disease spread May 2015 (Reported in June) Nov –Dec 2014 , in the areas not under the effective control of the Government of the Republic of Cyprus EMA - Stakeholder group on LSD vaccines (London, 31 January 2017)

EU LSD vaccine bank - History LSD in the EU Lum py Skin Disease outbreaks in 2 0 1 5 FYR ( Aug-Dec 2 0 1 5 )  1 st Occurrence in continental Europe ( Greece , 1 1 7 outbreaks)

EU LSD vaccine bank - History LSD Recurrence in the EU in 2 0 1 6 , April - 3 0 Nov 2 0 1 6 ( ADNS + country reports) FYROM LSD outbreaks in SE Europe Serbia Kosovo* 21 April 2016, Bulgaria (April – late Nov 2016) 5 June 2016, 24 June 2016 13 April 2016, 1st occurrence 1st occurrence 1 st occurrence 1st occurrence  Greece : 104 (last on 25/11/2016 ) Serbia Montenegro 21 July 2016  Bulgaria : 217 1st occurrence (last on 1/8/2016 ) Bulgaria Montenegro Kosovo  FYROM : 1.591 (Sep report) FYROM  Serbia: 225 Albania (last on 01/10/2016 ) 19 July 2016 Albania 1st occurrence  Kosovo*: 76 (Aug report) Greece Turkey  Montenegro: > 400  Albania: 1.932 (Oct report) ( * This designation is without prejudice to positions on status, and is in line with UNSCR Greece 1244 and the ICJ Opinion on the Kosovo 6 April 2016 recurrence Declaration of Independence). in area of low vaccine coverage LSD outbreaks 01.01-30.11.2016 (ADNS)

EU LSD vaccine bank - History LSD vaccination in South East Europe– Situation as at m id Nov 2 0 1 6 Vaccination completed in:  Bulgaria Croatia  Greece (Northern part)  Serbia  FYROM Bosnia &  Montenegro Herzegovina Serbia  Kosovo  Croatia Montenegro Kosovo Bulgaria Vaccination in progress in  Albania FYROM  Southern part of Albania continental Greece Greece Turkey Vaccination Completed Vaccination in progress LSD outbreaks as at 1 Jan -30 Nov 2016 (ADNS

EU LSD vaccine bank - History LSD in the EU in 2 0 1 6 -2 0 1 7 ( Situation as at Jan 2 0 1 7 )  All affected countries quickly resorted to vaccination against LSD  Croatia, a country not affected by LSD became the first to implement preventive vaccination  Further spread of LSD to the north or west seems to be halted for the moment (vaccination + winter)  No new LSD outbreaks reported in those affected countries where full vaccination coverage has been achieved (one LSD outbreak reported in ADNS in early 2017, under investigation)  Disease spread reported from countries with low vaccine coverage (e.g. Albania), also sporadic cases reported from the former Yugoslav Republic of Macedonia and isolated cases in non-vaccinated animals (e.g. Greece)  Affected countries where vaccination is still in progress put their efforts to complete their vaccination campaign as soon as possible and achieve high vaccine coverage. EMA - Stakeholder group on LSD vaccines (London, 31 January 2017)

EU LSD vaccine bank - History European Com m ission ( DG SANTE) response to LSD occurrence in continental Europe in 2 0 1 5 -2 0 1 6  Legal m easures Com Implementing Decisions on safeguard measures and vaccination  Expert support : 4 CVET LSD Missions in 2016 (Greece , Serbia, FYROM, Romania)  EFSA expert opinions  Training ( EU MS+ non-EU Mem ber countries) ─ 4 BTSF seminars in Greece (1 in 2015 + 3 in 2016) ─ Workshop on LSD (Sofia 22-25 November 2016) ─ 5 Sustained Technical assistance Missions (STMs) in Montenegro, Bosnia & Herzegovina, Kosovo* , Albania and Moldova in 2016.  I nternational coordination ( EU MS+ non-EU Mem ber countries) ─ Joint EFSA –DG SANTE Workshop (Brussels, 11-12 May 2016) ─ Standing Group of Experts on Lumpy Skin Disease in the South East Europe region under the GF-TADs umbrella (Brussels on 4-5 July, Lisbon on 21 September, Istanbul 12-13 December 2016). http: / / web.oie.int/ RR-Europe/ eng/ Regprog/ en_GF_TADS% 20- % 20Standing% 20Group% 20LSD.htm# LSD1 ─ Ministerial Conference on Lumpy Skin Disease, 8-9 Sep 2016, Sofia-Bulgaria.  Appointm ent of EURL for diseases caused by capripox viruses (lumpy skin disease and sheep and goat pox [ COMMISSION REGULATION (EU) 2 0 1 7 / 1 4 0 of 26 January 2017]  EU LSD Vaccine bank ( April 2 0 1 6 ) EMA - Stakeholder group on LSD vaccines (London, 31 January 2017)

EU LSD vaccine bank - History Legal Measures I m plem enting Decisions ( now repealed) for GREECE COMMISSION IMPLEMENTING DECISION (EU) 2 0 1 5 / 1 4 2 3 of 21 August 2015 concerning certain interim protective measures against lumpy skin disease in Greece COMMISSION IMPLEMENTING DECISION (EU) 2 0 1 5 / 1 5 0 0 of 7 September 2015 concerning certain protective measures against lumpy skin disease in Greece and repealing Implementing Decision (EU) 2015/ 1423 Amended by:  Commission Implementing Decision (EU) 2015/ 2055 of 10 November 2015  Commission Implementing Decision (EU) 2015/ 2311 of 9 December 2015  Commission Implementing Decision (EU) 2016/ 1116 of 7 July 2016  Commission Implementing Decision (EU) 2016/ 1255 of 29 July 2016 COMMISSION IMPLEMENTING DECISION (EU) 2 0 1 5 / 2 0 5 5 of 10 November 2015 laying down the conditions for setting out the program m e for em ergency vaccination of bovine animals against lumpy skin disease in Greece and amending Implementing Decision (EU) 2015/ 1500 Amended by :  Commission Implementing Decision (EU) 2015/ 2311 of 9 December 2015  Commission Implementing Decision (EU) 2016/ 1116 of 7 July 2016  Commission Implementing Decision (EU) 2016/ 1255 of 29 July 2016 EMA - Stakeholder group on LSD vaccines (London, 31 January 2017)

EU LSD vaccine bank - History Legal Measures I m plem enting Decisions ( now repealed) for BULGARI A COMMISSION IMPLEMENTING DECISION (EU) 2 0 1 6 / 6 4 5 of 22 April 2016 concerning certain protective measures against lumpy skin disease in Bulgaria Amended by:  Commission Implementing Decision (EU) 2016/ 1183 of 14 July 2016 COMMISSION IMPLEMENTING DECISION (EU) 2 0 1 6 / 1 1 8 3 of 14 July 2016 approving the em ergency vaccination program m e against lumpy skin disease of bovine animals in Bulgaria and amending the Annex to Implementing Decision (EU) 2016/ 645 EMA - Stakeholder group on LSD vaccines (London, 31 January 2017)

EU LSD vaccine bank - History Legal Measures New Com m ission I m plem enting Decisions on LSD  COMMISSION IMPLEMENTING DECISION EU ( 2 0 1 6 ) / 2 0 0 8 , of 15 November 2016 concerning animal health control measures relating to lumpy skin disease in certain Member States  COMMISSION IMPLEMENTING DECISION ( EU) 2 0 1 6 / 2 0 0 9 of 15 November 2016 approving the vaccination program m es against lumpy skin disease submitted by the Member States Advantages ─ Uniformity (one set of measures for LSD across the EU) ─ Proportionality (establishment of specific rules for affected zones and free w ith vaccination zones respectively) ─ Sustainability (reduced impact on trade) ─ Flexibility (e.g. possibility for bilateral agreements) ─ Lifting – refining of measures related to safe / low risk products (meat , milk) Note: All measures of Directive 92/ 119 on stamping out , suspicion, confirmation of LSD (e.g. surveillance – protection zones , measures and duration thereof) remain in place. EMA - Stakeholder group on LSD vaccines (London, 31 January 2017)

LSD m easures at EU level LSD zoning CI D ( EU) 2 0 1 6 / 2 0 0 8 & CI D ( EU) 2 0 1 6 / 2 0 0 9 , adopted 1 5 Nov 2 0 1 6 . Free zones with Vaccination ( Part I ): Croatia  Croatia  Bulgaria (certain areas in the North and East part) Infected zones ( Part II ): Bulgaria  Continental Greece (including the island of Limnos)  Bulgaria (excluding the ''free with vaccination'' zones) Greece Free with Vaccination zone Infected zone LSD outbreaks 2015 - 30.11.2016 (ADNS)