European Manufacturers of Veterinary Diagnostics EMVD

1. Association Européenne des Fabricants de Réactifs Vétérinaires AEFRV European Manufacturers of Veterinary Diagnostics EMVD Presentation on the activities of the EMVD Johanna Koolen

2. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD EMVD (former AEFRV) • History • Members • Aim • Priorities: • Harmonization of Regulations • Harmonization and OIE procedure • Unfair competition of Public Laboratories • Reference panels • European affairs: ETPGAH participation • Conclusion

3. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD AEFRV / EMVD History • The Association in its current form (an association under the French associative law of 1901) was created in 2005 with the goal to defend the interests of veterinary diagnostics producers • The major subjects: • the harmonization of the complicated European Regulatory situation for veterinary diagnostics • the unfair competitive position of some public laboratories (producers of diagnostics and evaluators of the quality of our commercial kits, resulting in a judge and jury situation) • The active collaboration with the OIE to make their new registration procedure for veterinary diagnostics more interesting as a marketing tool (for manufacturers), with the ultimate goal to have an acceptable procedure for governments having their own registration procedure (become actors of harmonization)

4. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD EMVD Members • Applied Biosystems • Agrolabo, Italy • Bio-X Diagnostics, Belgium • IDEXX Europe, Netherlands • INGENASA, Spain • Institut Pourquier, France • MegaCor, Germany • Prionics, Netherlands • Svanova, Sweden • SYNBIOTICS Europe, France

5. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Members of the Board • Chair: Johanna Koolen - Applied Biosystems • Secretary: Annita Ginter - Bio-X Diagnostics • Treasurer: François Merit - IDEXX • Vice Chair: Liesbeth Jacobs – Prionics • Vice Chair: Malik Merza – Svanova • Vice Chair: Serge Leterme – IDEXX • Secretariat: SIMV France (meeting rooms, Web site creation & updating, administrative actions)

6. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Veterinary Diagnostics…. • Are an excellent tool to control disease…. • However technically the same, very different from human diagnostics: • Pricing: Tests are cheaper, they have a direct influence on the meat price • “Patients” are divided into different species • Different regulations apply • Technically the same but different from food safety and environmental testing: Mainly due to a different regulation

7. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Aims • Have a representation of the animal health diagnostics industry on a European level. Being a European association provides a legitimacy to defend the interests of the industry • Become an actor instead of a spectator: be a privileged interlocutor and obtain information on regulatory changes that affect our business and European initiatives in general. • Result: the EMVD has representatives in different committees: • Animal Health Advisory Committee AHAC of the general directorate of consumers’ health (DG Sanco) of the European commission • DG Sanco Vaccine task force • The executive board of the European Technology platform for global animal health – ETPGAH • Discontools (ETPGAH) enabling the relay of relevant information to its members • Be a privileged contact for the OIE in their combat to improve animal health

8. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Harmonization of existing regulations on Veterinary Diagnostics (1) • In many countries of the world, Veterinary Diagnostics are actively regulated, having vaccine regulations as a basis. The regulation is therefore (too) stringent and registration laborious. Example: USA; Japan; China • In Europe, some countries like Germany, Spain and some others actively regulate veterinary diagnostic tests, or ty to implement new regulations (France) • There are different coexisting regulations and also norms, that are costly in time and fees

9. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Harmonization of existing regulations on Veterinary Diagnostics (2) • Batch control: Many (European) countries have batch control for each batch of product that is commercialized. Batch controls are not recognized between European member states. • Batch control also exists in countries where there is no national registration procedure As a result the same batch is tested by different reference laboratories, thereby multiplying our costs.

10. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Harmonization and OIE procedure (1) In May 2005, the OIE registration Procedure was launched: • This registration procedure comes in complement to the existing ones and is very costly (9000 € every 5 years, plus 0.1% of the annual sales as additional tax and is recently revised to 4500€). • Moreover: The procedure itself is long and requiring quite some investment in time and money for “fitness for purpose studies” as asked in the procedure • Most importantly: there is no recognition by other countries having their own registration procedure

11. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Harmonization and OIE procedure (2) The OIE registration Procedure is available on the Internet: • We noticed that different authorities copy the requirements of the procedure into their public tenders. This results in an increased number of requirements that we cannot always fulfill. • We proposed to split the real requirements and additional information and keep only the requirements on the Web site.

12. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Harmonization and OIE procedure (3) PROPOSAL: The EMVD worked with the OIE to come to a convergence of interests to have the procedure evolve into • A procedure that: • Is easier to apply • Is less expensive • Will be recognized by countries having an active regulation on veterinary diagnostics in the future • Has a shorter timeline

13. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Harmonisation and OIE procedure (4) RESULT: • The procedure : • Was simplified • Price was lowered from 9000 to 4500 Euros • …. Today the successful registration by OIE does not dispense from registrations in other countries. To be able to create a register of quality diagnostic tests, the recognition is a prerequisite. It therefore stays a marketing tool (for the moment)

14. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Reference Material • The constitution and use of reference material is crucial for the activity of diagnostics producers • There is no news on this side. It is considered an activity of the OIE reference laboratories, they should provide validated panels that permit to establish standards. • Diagnostic manufacturers are willing to help with the filling of large quantities of reference material – they have the material to perform this task

15. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD ETPGAH European Technology Platform for Global Animal Health • Contributions of the EMVD: • Actively involved in the elaboration of the Vision Paper; Strategic Research agenda (SRA) and Action Plan • The EMVD is present in the executive board of the ETPGAH since 2006 • The main conclusions were to continue developing the action items through a new network, called DISCONTOOLS and the creation of national mirror groups

16. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD ETPGAH / Discontools / Mirror Groups • EMVD members are taking part in the different DICONTOOLS work groups of experts, working on priorization of diseases, gap analyses (availability of products, gaps in regulation, gaps in knowledge), new technologies (speed up time lapse between invention and innovation)… • EMVD members are encouraged to participate actively in the national mirror groups that have been created all over Europe

17. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Competition of Public Laboratories (1) • Diagnostics producers undergo harsh competition from public laboratories whose primary goal is to provide surveillance to animal health, by acting as an independent reference laboratory for national governments. Some of them are also OIE reference laboratories. • Their expertise is highly appreciated and some perform research on a high level • However, some public laboratories produce veterinary diagnostics and commercialise them or commercialize their services with home brew diagnostics.

18. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Competition of Public Laboratories (2) • Some public laboratories block the market, as their method or test is the only one authorized (despite of the existence of better tests or methods) • We feel that a diagnostics producing public laboratory cannot objectively evaluate commercial tests • Public laboratories do not always adhere to a quality system (ALL EMVD members are at least ISO certified)

19. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Competition of Public Laboratories (3) The EMVD discloses this conflict of interest. This is unfair competition and moreover, it does not promote animal health There is a possibility to present cases, and file complaints to DG Enterprise who can intervene with the commission Action: resume the current unfair competitive situations still present in Europe and submit in a report to DG Enterprise (this consultation is running until December 15)

20. Association Européenne des Fabricants de Réactifs Vétérinaires European Manufacturers of Veterinary Diagnostics EMVD Conclusions • Harmonization of existing regulation is welcomed: The OIE procedure could play this role if recognized by countries having a national registration • The unfair competitive position of public laboratories should be resolved • Recognition of batch controls is needed between (European) countries Could this be a role for the OIE reference laboratories?