General Presentation - EMVD European Manufacturers of Veterinary Diagnostics

1. General Presentation - EMVD European Manufacturers of Veterinary Diagnostics Johanna Koolen Chair of EMVD - European Manufacturers of Veterinary Diagnostics

2. EMVD • History – Who are we? • Members • Engagement • Our “Know-How” • Regulations on veterinary diagnostics in Europe • Priorities • Objectives

3. A bit of History… • First official meeting in March 2006 in Brussels • Defend the interests of manufacturers of Animal Health Diagnostics • Headquarters based in Paris in SIMV offices • Many small or medium sized companies • Our members operate under ISO 9001, at least • Together we represent the majority of veterinary diagnostics producers in the world: • Most members have global presence • Concentration of this market in EU ( “Diagnosis Approach” vs. “Vaccination Approach”) • We are especially well represented in Western Europe

4. Presence EMVD Members

5. Board members • Secretary: Annita Ginter, BioX Diagnostics, Belgium • Tresurer: François Merit, IDEXX, France • Vice President: Liesbeth Jacobs, Prionics, Netherlands • Vice President: Malik Merza, Svanova, Sweden • Vice President: Serge Leterme, IDEXX, Switzerland • Chair: Johanna Koolen, Life Technologies, France • Secretariat: SIMV, France: Claire Baradat • Web site: www.aefrv.eu

6. EMVD engagements • Be a recognised stakeholder on an international level (because of our global presence) for NGOs such as OIE • Participation as “Observer” in the OIE ad hoc group on Validation of diagnostic assays • Representation of the AH diagnostic sector in IAEA/FAO/OIE joint meetings on the validation of diagnostics • Be a recognised stakeholder on an EU level towards regulators, committees, veterinary health industry • DG Sanco Vaccine task force • Animal Health Advisory Committee AHAC (DG Sanco) • Executive board of the European Technology platform for global animal health • Project Management Board of Discontools • We currently request DG Sanco for a suitable regulatory framework

7. What can we do for you? We bring highly innovative products on the market: Our know-how highly innovative products SMEs with veterinarians leading the business and which prove great reactivity and flexibility LEADERS in Biotechnology, key players in the Life Science market , who provide “high-tech” solutions What can we offer? Knowledge on technology and regulatory requirements (veterinary, food safety and human diagnostics) Certain members are part of animal health vaccine and pharmaceutical companies

8. EU Regulatory situation for Diagnostics in Animal Health • Regulation per disease by EU directives (CSF, Aujeszki’s Disease, Rabies, Bluetongue…) • 27 different ways to interpret an EU directive • Resulting into burdensome situations where products need marketing authorisations in some countries, or batch liberation in others, or both… • In countries where no regulation exists, public labs are responsible for executing the tests and may decide to use in-house tests • OIE has made an attempt to provide a harmonised procedure, but is however poorly used, because countries do not recognise the OIE procedure next to their national procedure

9. Dialog with NGOs (OIE, FAO, ..): • converge interests • support initiatives for harmonisation • Dialog with EU commission: • Find support for an • AH IVD directive EMVD Priorities Express need for Harmonization to regulate veterinary Diagnostics in the EU Denounce Unfair competition from public laboratories Promote mutual recognition of batch control by EU Member States

10. Objectives • Support / drive the initiative of a legal framework for AH diagnostics and defend the “Problem definition” we sent to DG Sanco • Partner animal Health initiatives: • OIE, FAO and IAEA • Epizone • Discontools • ETPGAH • EPRUMA • ….

11. Thank you