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,

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OIE First Global Conference on Veterinary Legislation

Control of Veterinary Control of Veterinary Products: The Need for Products: The Need for

Global StandardsGlobal 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

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““One World, One Health” One World, One Health” ConceptConcept

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

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Need for Harmonized Need for Harmonized International Standards for International Standards for Veterinary ProductsVeterinary 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

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Standards Relevant to Veterinary Standards Relevant to Veterinary Products that Need to be Products that Need to be

Harmonized InternationallyHarmonized 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

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Important International Veterinary Important International Veterinary Products Standard-Setting Venues in Products Standard-Setting Venues in

which FDA Participateswhich 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

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Major International Major International Standards Harmonization Standards Harmonization

Efforts Efforts

WHO/FAO Codex Alimentarius Commission

*International Cooperation on Harmonization of Technical

Requirements for Registration of Veterinary Medicinal

Products*

World Organization for Animal Health

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Codex Committee on Residues of Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF)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

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Codex Task Force on Codex Task Force on Antimicrobial Resistance Antimicrobial Resistance

(TFAMR)(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

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Codex Task Force on Animal Codex Task Force on Animal Feeding (TFAF)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

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World Organization for World Organization for Animal HealthAnimal Health

• Terrestrial Animal Code

– BSE

– AMR

• Aquatic Animal Code

– Use of animal drugs in aquaculture

• OIE Fifth Strategic Plan

– Strengthening Veterinary Medicines Regulatory Infrastructures

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

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Goals of VICHGoals 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

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AchievementsAchievements

• 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

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Developed Developed GuidelinesGuidelines

• 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)

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VICH Global VICH Global OutreachOutreach

• 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

– 5th Strategic Plan of OIE – promotion of VICH standards

• OIE National Focal Points for Veterinary Products meetings

– Serbia, Colombia, South Africa

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Benefits of Harmonizing Benefits of Harmonizing International Veterinary Medicinal International Veterinary Medicinal

Product StandardsProduct 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

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Difficulties Involved in Achieving Difficulties Involved in Achieving International Harmonization of Product International Harmonization of Product

Standards and Testing ProtocolsStandards 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

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Scientific Process versusScientific Process versusLegal ProcessLegal 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

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Differing Legal/Value Judgments that Differing Legal/Value Judgments that Affect the International Harmonization of Affect the International Harmonization of

Science-Based Product Standards and Science-Based Product Standards and Testing ProtocolsTesting 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

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““Bridging the Gap”Bridging the Gap”

Objective Data Common Goals

(science-based (safe and effective

studies) medicines)

SubjectiveElements

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““Bridging the Gap”Bridging the Gap”

• Attempts to deal with subjective elements that affect product standards, testing protocols, and conformity assessments include…

– Codex’s “Other Legitimate Factors”

– Use of Risk Analysis methodology

• But many national laws and values reflect the essence of what constitutes each country’s identity

• Importance of transparency and of making every effort to separate scientific “fact” and value judgments

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Merci!Merci!Thank you!Thank you!