1. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires IAEA Consultants Meeting on Standards, referencing and validation November 21-24, 2006 Vienna, Austria

2. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires AEFRV  History  Members  Priorities: Harmonization of Regulations & OIE procedure & Recommendations Reference panels European affairs: ETPGAH participation Unfair competition of Public Laboratories  Conclusion

3. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires AEFRV History  The Association was initially created in 2000 with the goal to defend the interests of diagnostics producers, by working on two major subjects: the harmonization of the complicated European Regulatory situation for veterinary diagnostics the false competitive position of some public laboratories (producers of diagnostics and controlling at the same time our commercial activity).  The adoption of the OIE procedure May 2005, experienced as an addition to existing rules and fees, was an impulse to resuscitate the association

4. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires AEFRV Members  Note: The majority of our members are small enterprises  BioX  CEDI Diagnostics  Guildhay  IDEXX  INGENASA  MegaCor  Institut Pourquier  SIMV  Svanova  SYNBIOTICS

5. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires  Active Regulation is present in many countries of the world, most often using vaccine regulations as a template. The regulation is therefore stringent. Example: USA; Japan; China  In Europe, some countries like Germany, Spain, Portugal and some others actively regulate veterinary diagnostic tests  As a result there are different coexisting regulations, that are costly in time and fees. Harmonization of existent regulations on Veterinary Diagnostics (1)

6. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires  Batch control: Some countries have batch control for each batch of product that is commercialized. Batch controls are not recognized between European member states.  As a result the same batch is tested by different reference laboratories, thereby multiplying marketing costs. Harmonization of existent regulations on Veterinary Diagnostics (2)

7. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires 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).  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. Harmonization of existent regulations on Veterinary Diagnostics (3)

8. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires ACTION:  The AEFRV and the OIE are actually working on the convergence of interests to make the procedure evolve into something workable for the OIE and our members Harmonization of existent regulations on Veterinary Diagnostics (4)

9. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires Recommendations Harmonization & OIE procedure  The AEFRV recommends the procedure to be more accessible, less expensive, without any annual tax  The AEFRV recommends to have the procedure recognized and accepted as an alternative procedure by countries having an active regulation on veterinary diagnostics  The AEFRV will support joint OIE / EU initiatives to streamline existent regulations and regulation projects into a more workable regulatory situation

10. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires  AEFRV members think that manufacturers of veterinary diagnostics should be actively involved in the constitution of these sera panels in cooperation with organizations such as the OIE reference laboratories.  Requirements for reference sera / panels: Quantities should be large Sera should be accessible to manufacturers, public laboratories, OIE laboratories Many other items: Refer our current discussions The constitution of reference sera or panels

11. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires European Affairs: - ETPGAH (1) The aim of the Technology Platform is:  To facilitate and accelerate the development and distribution of the most effective tools for controlling animal diseases of major importance to Europe and the rest of the world, thereby improving human and animal health, food safety and quality, animal welfare, market access, contributing to achieving the Millennium Development Goals

12. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires  To attain this goal, the technology platform formulated a number of strategic objectives that concentrate on animal health, welfare and well-being, the control of zoonotic diseases, maintenance of competitive industry, facilitating the transfer of discoveries by providing a constructive regulatory environment, develop global alliances with international organizations, improve education, alleviate poverty in developing countries, create private-public partnerships.  A vision paper underlining this goal was published and a strategic research agenda was elaborated, which formulates a number of recommendations (>60). European Affairs: - ETPGAH (2)

13. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires Contributions of the AEFRV since last March:  Elaboration of Chapter 6.4 in the Strategic Research agenda (SRA) with a number of recommendations  These recommendations are addressed by 4 coordination groups in which the AEFRV is present  The AEFRV is represented in the board of the ETPGAH since last Summer European Affairs: - ETPGAH (3)

14. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires  The implementation of the SRA should result in a correct prioritization of animal diseases, enabling the research directorate to allocate research budgets to priority projects.  Why should diagnostic producers be present?  The tool for the control of animal disease is often the diagnostic product alone: In many cases vaccination is not allowed.  Diagnostics producers have the know-how to discuss the role of diagnostics with experts from public research institutions and the vaccine industry. European Affairs: - ETPGAH (4)

15. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires Competition of Public Laboratories  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 diagnostic reagents, and commercialize them.

16. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires Competition of Public Laboratories  In Europe, some public laboratories block the market, as their method or test is the only one authorized (even if better tests or methods exist)  We feel that a diagnostics producing laboratory cannot objectively evaluate commercial tests  Public laboratories do not always adhere to a quality system (Most diagnostic producers are ISO certified)  The AEFRV discloses this conflict of interest

17. European Association of Veterinary Diagnostics manufacturers Association Européenne des Fabricants de Réactifs Vétérinaires Conclusion  The AEFRV will continue to work on these items!