1. OIE First Global Conference on Veterinary Legislation 1 Control of Veterinary Products: The Need for Global Standards Merton V. Smith, Ph.D., J.D. Director, International Programs Office of the Director Center for Veterinary Medicine U.S. Food and Drug Administration 7-9 December 2010 Djerba, Tunisia

2. 2 One World, One Health Concept General Principles: – human-animal disease link – ecosystem interdependences, including effect of trade in animal products – need for holistic approaches to controls – adequate investment in global human and animal health infrastructure controls – need for intergovernmental collaborative relationships – assurance of adequate resources

3. 3 Need for Harmonized International Standards for Veterinary Products Veterinary medical products most often require pre-market approval Many veterinary medical products are traded in international commerce Foods and feeds (potentially containing drug residues) are traded in international commerce

4. 4 Standards Relevant to Veterinary Products that Need to be Harmonized Internationally Veterinary drug approval standards and procedures – including safety of drug residues in human food Antimicrobial resistance monitoring Pharmacovigilance procedures Safety standards for feed and feed ingredients Biotechnology assessment standards for veterinary medicines, food, and feed

5. 5 Important International Veterinary Products Standard-Setting Venues in which FDA Participates Multilateral – Codex Alimentarius – OIE – VICH – CAMEVET – Quad countries – Trilateral forum – Others: OECD, ISO, ASEAN Bilateral – Canada (VDD and CFIA) – EU (EMA, DG SANCO, and EFSA) – China (AQSIQ, SFDA, and MOA) – Others: India

6. 6 Major International Standards Harmonization Efforts WHO/FAO Codex Alimentarius Commission * International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products * World Organization for Animal Health

7. 7 Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) Recommends Maximum Residue Limits (MRLs) for veterinary drugs Develops codes of practice related to the use of veterinary drugs in food-producing animals Considers methods of sampling and analysis for the determination of drug residues in foods

8. 8 Codex Task Force on Antimicrobial Resistance (TFAMR) Develop guidance to assess human health risks associated with the presence in food and feed and the transmission through feed and food of antimicrobial resistant microbes and resistance genes Develop guidance to allow countries or regions to implement risk management strategies based upon identified and prioritized needs and resources

9. 9 Codex Task Force on Animal Feeding (TFAF) Apply existing Codex risk assessment methodologies to hazards related to contaminants and residues in feed ingredients Develop a prioritized list of feed ingredient hazards Establish criteria for the global identification and notification of emergency situations affecting the feed sector and, ultimately, the food sector

10. 10 World Organization for Animal Health Terrestrial Animal Code – BSE – AMR Aquatic Animal Code – Use of animal drugs in aquaculture OIE Fifth Strategic Plan – Strengthening Veterinary Medicines Regulatory Infrastructures

11. 11 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

12. 12 Goals of VICH To establish harmonized technical requirements for registration or licensing of veterinary medicinal products (i.e., protocols and testing standards for studies required to show the safety, efficacy and quality of veterinary medicines) Also includes post-approval reporting requirements for adverse drug events

13. 13 Achievements VICH officially began in April 1996 It established – Structure (Steering Committee and Expert Working Groups) – Membership (regulatory and industry representatives from Japan, U.S., EU, Canada, Australia, and New Zealand; observers from OIE and IFAH) – Procedures – Work program

14. 14 Developed Guidelines Quality Safety Good Clinical Practices Anthelmintic efficacy Ecotoxicity Biologicals quality Pharmaco/ vaccinovigilance Antimicrobial resistance Target animal safety Metabolism and residue kinetics Microbiological ADI Acute Rf Dose (under development) Bioequivalence (under development)

15. 15 VICH Global Outreach VICH Global Outreach Working Group met in Washington, DC, on October 7-8, 2009, and in Paris on December 1-2, 2010 OIE/VICH cooperation – 5 th Strategic Plan of OIE – promotion of VICH standards OIE National Focal Points for Veterinary Products meetings – Serbia, Colombia, South Africa

16. 16 Benefits of Harmonizing International Veterinary Medicinal Product Standards International venues for exchange of concerns and issues between industry, consumers, and regulators Harmonized testing standards result in wider and faster availability of safe and effective veterinary medicinal products, foods, and feeds worldwide Opportunity to update regional standards

17. 17 Difficulties Involved in Achieving International Harmonization of Product Standards and Testing Protocols Some argue that WTO rules and international standards may result in lower standards for safety and health Others maintain that international harmonization and collaboration unnecessarily raise standards Product regulation is both science-based and law-based – in many ways two very different and incompatible methodologies

18. 18 Scientific Process versus Legal Process Science Truth-seeking Consensus building Issues capable of objective description Timeliness is unimportant Law Decision-seeking Adversarial Issues are usually described in subjective or value-laden terms Timeliness is very important

19. 19 Differing Legal/Value Judgments that Affect the International Harmonization of Science-Based Product Standards and Testing Protocols Proper role of the government versus the proper role of the private sector in safety regulation Adequacy of resources available for public health and animal health protection Proper balancing of animal health protection and human health protection

20. 20 Bridging the Gap Objective Data Common Goals (science-based(safe and effective studies) medicines) Subjective Elements

21. 21 Bridging the Gap Attempts to deal with subjective elements that affect product standards, testing protocols, and conformity assessments include… – Codexs Other Legitimate Factors – Use of Risk Analysis methodology But many national laws and values reflect the essence of what constitutes each countrys identity Importance of transparency and of making every effort to separate scientific fact and value judgments

22. 22 Merci! Thank you!