OIE First Global Conference on Veterinary
Legislation
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
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“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
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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
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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
•
•
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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
Products Standard-Setting Venues in
which FDA Participates
• Multilateral
• Bilateral
– Codex Alimentarius
– OIE
– VICH
– Canada (VDD and
– CAMEVET
– Quad countries
– Trilateral forum
– China (AQSIQ, SFDA,
CFIA)
– EU (EMA, DG
SANCO, and EFSA)
and MOA)
– Others: India
– Others: OECD, ISO,
ASEAN
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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
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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
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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
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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
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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
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International
Cooperation on
Harmonization of
Technical
Requirements for
Registration of
Veterinary
Medicinal Products
(VICH)
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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
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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
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Developed Guidelines
• Quality
• Antimicrobial resistance
• Safety
• Good Clinical Practices
• Anthelmintic efficacy
• Target animal safety
• Metabolism and residue
• Ecotoxicity
• Biologicals quality
• Pharmaco/
vaccinovigilance
kinetics
• Microbiological ADI
• Acute Rf Dose (under
development)
• Bioequivalence (under
development)
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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
– 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 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
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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
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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
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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
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“Bridging the Gap”
Objective Data
Common Goals
(science-based
(safe and effective
studies)
medicines)
Subjective
Elements
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“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!
Thank you!
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