This document discusses international efforts to harmonize standards for veterinary products. It describes the roles of organizations like Codex, OIE, VICH, and CVM in developing consensus standards. The goals are to ensure veterinary products are safe, effective, and of high quality globally in order to protect public health, animal health, and facilitate trade. Efforts focus on harmonizing requirements for product approval and regulation.

1. OIE Global Conference on Veterinary Legislation35
Control of veterinary products:
the need for global standards
M.V. Smith
Director, International Programs and Product Standards, Office of the Director,
Center for Veterinary Medicine, US Food and Drug Administration, 7519 Standish Place,
Rockville, MD 20855, USA
Correspondence: merton.smith@fda.hhs.gov
Summary
Veterinary medicinal products (VMPs) are key tools for protecting both public and animal health and therefore
need to be, safe, efficacious and of high quality. These objectives can be attained at an international level if
governance regarding VMPs is well structured and international standards are developed and utilised.
In the first part of this paper, the current situation regarding international harmonisation of standards for
VMPs is presented, in particular the achievements to date of the Codex Committee on Residues of Veterinary
Drugs in Foods (CCRVDF) and International Cooperation on Harmonisation of Technical Requirements for
Registration of Veterinary Medicinal Products (VICH) are considered, in addition to other relevant perspectives.
The role of CCRVDF is to establish maximum residue limits for drugs used in veterinary medicine in order to
protect consumer safety and to facilitate trade. The World Organisation for Animal Health (OIE) contributes to the
development of consensus within the CCRVDF and acts as a partner to the Food and Agriculture Organization
(FAO) and the World Health Organization (WHO), both United Nations agencies, in the development of animal
production food standards, guidelines, and related texts such as codes of practice.
VICH is a trilateral (European Union–Japan–USA) programme aimed at harmonising the technical requirements
for demonstrating product safety, efficacy and quality that are needed for veterinary product licensing or
registration. VICH was created under the auspices of the OIE which participates in the VICH by providing
oversight and direction as part of the VICH Steering Committee and helps to disseminate information to the
178 OIE Member Countries and Territories. By sharing VICH guidelines and principles, countries and regions
can better understand the scientific basis and the public health and animal health protection principles that
underlie the approval of veterinary medicines in the VICH-participating countries and can leverage that
information as they may deem appropriate in their own national approval procedures.
In the second part of the paper, improvement of the global governance of VMPs within the framework of the
OIE Fifth Strategic Plan is presented, along with relevant objectives and methodology. The official governance
of VMPs covers a wide range of responsibilities: registration, inspection, surveillance, communication,
information-sharing, training, and other regulatory controls. In this way national Competent Authorities play a
key role with respect to the improvement of animal health, animal welfare, public health and the establishment
of the required legislative base for relevant programmes and activities. Good governance, on the one hand,
improves and supports the availability of VMPs and, on the other hand, is necessary to fight against fraud
and the placement of counterfeit, ineffective or even dangerous products on the market. Regulatory controls
of VMPs by national or regional Competent Authorities implemented through legislation that is harmonised,
as appropriate, with international standards, are essential tools to ensure a high-quality and efficient market.
In that way, good governance and veterinary legislation also support fair trade.
In the last part of this paper, the difficulties in harmonising regulatory standards and the difficulties faced by
science-based regulatory authorities in integrating risk assessment and risk management in the risk analysis
decision-making process are described.
Keywords
CCRVDF – Codex – Legislation – Standards – VICH – VMPs.

2. 36 OIE Global Conference on Veterinary Legislation
Session 1 The current state of play: the legislative landscape globally and regionally
Introduction
For the last two and a half decades the development of international standards for controlling the approval and
use of veterinary medicines and for controlling the safety of veterinary feeds and pet foods has been an important
priority of the Center for Veterinary Medicine (CVM) at the US Food and Drug Administration (FDA). International
consensus on product and production standards and on conformance assessment procedures has resulted in
greater assurance of the safety and quality of veterinary medicines and of foods derived from animals – for those
products sold domestically as well as for those traded across national boundaries. The most important bilateral
and multilateral standard-setting activities in which CVM has been participating, and some of the benefits and
difficulties of developing international standards, are described below.
The FDA’s Center for Veterinary Medicine
The approximately 500 CVM personnel are located within the Department of Health and Human Services
(DHHS is equivalent to the Ministry of Health in most countries). CVM is responsible for approving all veterinary
drugs prior to their marketing in the USA and for helping to assure the safe use of those products after they are
approved. In addition to veterinary drugs, CVM also exercises regulatory authority over the safety of animal feeds
and pet foods. In the USA the authority to regulate veterinary biologicals (e.g. vaccines) resides with the Center
for Veterinary Biologics in the Animal and Plant Health Inspection Service (APHIS), an agency that is part of the
US Department of Agriculture.
Pharmaceutical industry sponsors who are seeking approval to use their products in the USA are required to
provide data and other information to CVM for review. The information contained in applications provides the
primary basis for CVM to evaluate or assess the safety, efficacy and quality of veterinary drugs used in the USA.
It is important to note that CVM regulates veterinary products and does not regulate the practice of veterinary
medicine. In the USA the practice of veterinary medicine and the relationship between the veterinarian and his
or her patients is controlled primarily by relevant local state veterinary licensing authorities. There is an important
exception to this general rule, however, and that is where the practice of veterinary medicine may affect the safety
of animal-derived human food (e.g. drug residues that may be found in food or the development of resistance in
microorganisms associated with food from animals that have been treated with antimicrobial drugs). These food
safety issues involve more than just the veterinarian and the patient. Thus, CVM does have a role in overseeing
the practice of veterinary medicine in food-producing animals in order to protect the interest of a third party – the
consumer of the food.
One World, One Health
We are all familiar with the principles that underlie the ‘One World, One Health’ concept:
−− recognition of the human–animal disease link
−− ecosystem interdependences, including the effect of trade in animal products
−− the need for holistic approaches to controls
−− adequate investment in global human and animal health infrastructure controls
−− the need for intergovernmental collaborative relationships
−− assurance of adequate resources.
CVM understood and practised the concept of ‘One World, One Health’ long before it became popular in the
early 1990s. CVM is the only part of DHHS that has responsibility for animal health as well as human health. CVM
clearly understands that we cannot think in terms of animal health or human health but must always find the right
balance for both with the resources we have at hand.

3. OIE Global Conference on Veterinary Legislation37
The current state of play: the legislative landscape globally and regionally Session 1
Harmonisation of veterinary product standards and assessment criteria
Within veterinary legislation, the requirements for veterinary products should, as much as possible, rely on
internationally agreed standards for the following reasons:
−− Veterinary medical products and many feed and pet food ingredients very often require pre-market approval,
and such approvals can be facilitated through the use of international standards and the sharing of comparable
data and information.
−− Many veterinary medical products and animal food ingredients are traded in international commerce, and
common standards can help to make these products available more rapidly and more widely.
−− Adverse events should be reported rapidly between and among countries, and common pharmacovigilance
standards can improve the dissemination of this information.
−− Animal-derived foods (potentially containing drug residues or resistant organisms) are traded in international
commerce, and international standards can help to assure food safety and food security.
The standards that are relevant to veterinary products that need to be harmonised internationally include the
following:
−− assessment criteria and procedures for veterinary medicine approvals (including those related to the safety
of drug residues in human food)
−− antimicrobial resistance monitoring, including analytical methods
−− pharmacovigilance procedures
−− criteria and procedures for assessing the safety of feed and feed ingredients and pet foods and pet food
ingredients
−− good manufacturing practices for veterinary medicines and foods
−− good agricultural and good aquacultural practices for animal-derived foods
−− biotechnology safety and efficacy assessment criteria and procedures for veterinary medicines, food and feed.
−− good laboratory practices for tests that support veterinary product approvals
−− good clinical practices for studies that support veterinary product approvals.
Important international veterinary products standard-setting venues
In association with the following countries and international organisations, CVM actively participates in a number
of international standard-setting and guidance-developing activities and programmes including the following:
Multilateral
−− FAO/WHO Codex Alimentarius Commission
−− WHO expert committees and consultations
−− FAO expert committees and consultations
−− OIE Terrestrial Animal Code and Aquatic Animal Code and expert committees and consultations
−− International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal
Products (VICH)
−− Committee for Veterinary Medicines of the Americas (CAMEVET)
−− Canada, Australia, New Zealand in the Quadrilateral Meeting (QUAD)
−− Canada and Mexico in the Trilateral Forum
−− Others: Organisation for Economic Cooperation and Development (OECD), International Organization for
Standardization (ISO), Association of Southeast Asian Nations (ASEAN), Asia–Pacific Economic Cooperation
(APEC) and the TransPacific Partnership (TPP).
Bilateral
−− Canada (Veterinary Drugs Directorate [VDD] of Health Canada and Canadian Food Inspection Authority [CFIA])
−− European Union (European Medicines Authority [EMA], Directorate-General for Health and Consumers [DG
SANCO], Food and Veterinary Office [FVO], and European Food Safety Authority [EFSA])

4. 38 OIE Global Conference on Veterinary Legislation
Session 1 The current state of play: the legislative landscape globally and regionally
−− China (People’s Republic of) (General Administration of Quality, Supervision, Inspection, and Quarantine
[AQSIQ], State Food and Drug Administration [SFDA] of the Ministry of Health, and Institute of Veterinary
Drug Control [IVDC] and the Bureau of Veterinary Medicines of the Ministry of Agriculture)
−− Japan (National Veterinary Assay Laboratory [NVAL] in the Ministry of Agriculture, Forestry and Fisheries
[MAFF] the Ministry of Health, Labour, and Welfare [MHLW], and the Food Safety Commission)
WHO/FAO Codex Alimentarius
CVM regularly participates in the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF). The
CCRVDF recommends maximum residue limits (MRLs) for veterinary drugs, develops codes of practice related
to the use of veterinary drugs in food-producing animals, and considers methods of sampling and analysis for
the determination of drug residues in foods. Since initiating its work in 1986, the CCRVDF has established a
total of 598 MRLs involving seven different tissues, 16 species of animals, and a total of 56 veterinary drugs. The
CCRVDF also drafted the Compendium of Methods of Analysis as Suitable for Support to Codex MRLs. The USA
has been the host country for CCRVDF since it began, and CVM personnel serve as the Chair of the CCRVDF
and as the lead of the US Delegation.
CVM participated in the Codex Task Force on Antimicrobial Resistance (TFAMR), which was hosted and chaired
by the Government of the Republic of Korea during 2007–2010. The TFAMR developed guidance to assess the
human health risks associated with the presence in food and feed, and the transmission through food and feed
of antimicrobial-resistant microbes and resistance genes, and developed guidance to allow countries or regions
to implement risk management strategies based upon identified and prioritised needs and resources. CVM led
the US Delegation to the TFAMR. The TFAMR finished its work in October of 2010 and its guidance was ratified
by the Codex Alimentarius Commission in July of 2011. CVM is now developing plans in cooperation with several
other countries on how to specifically implement this important Codex guidance.
CVM participates in the Codex Task Force on Animal Feeding (TFAF), which is hosted and chaired by the
Government of Switzerland. TFAF is developing guidance on how to apply existing Codex risk assessment
methodologies to hazards related to contaminants and residues in feed ingredients, a prioritised list of feed
ingredient hazards, and criteria for the global identification and notification of emergency situations affecting the
feed sector and, ultimately, the food sector. CVM leads the US Delegation to the TFAF.
CVM also participated in the development of the following Codex guidances: Principles for the Risk Analysis of
Foods Derived from Modern Biotechnology; Guideline for the Conduct of Food Safety Assessment of Foods
Produced Using Recombinant-DNA Microorganisms; Code of Practice on Good Animal Feeding; Code of Practice
to Minimise and Contain Antimicrobial Resistance; and Guideline for the Conduct of Food Safety Assessment of
Foods Produced Using Recombinant-DNA Microorganisms.
The outcomes of all of these Codex standard-setting activities have wide-ranging influence worldwide because
most countries carefully consider these guidances when they establish national standards, and many countries
directly adopt Codex standards as their national trade and public health measures.
World Organisation for Animal Health
CVM has worked with OIE for many years on issues of mutual importance including its Terrestrial Animal Code
covering bovine spongiform encephalopathy (BSE) and antimicrobial resistance (AMR). CVM experts have also
helped to develop the OIE Aquatic Animal Code covering the use of animal drugs in aquaculture.
The OIE World Assembly approved CVM’s application to become an OIE Collaborating Centre at its May 2011
meeting. As the OIE Collaborating Centre for Veterinary Drug Regulatory Programmes, CVM helps support
OIE’s initiatives (as described in the OIE’s Fifth Strategic Plan) to strengthen the veterinary medicine regulatory
infrastructures of OIE Members. An important part of this work involves working with the OIE Focal Points for
Veterinary Products and with other similar OIE Collaborating Centres such as L’Agence Nationale du Médicament
Vétérinaire in France and the National Veterinary Assay Laboratory in Japan. CVM believes strongly that this work
is serving to make safe and effective veterinary medicines more available worldwide in order to combat animal
disease and to help assure the safety of food derived from animals.

5. OIE Global Conference on Veterinary Legislation39
The current state of play: the legislative landscape globally and regionally Session 1
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products
Since VICH began in April 1996, CVM has been an active participant through both the VICH Steering Committee
and the VICH Expert Working Groups (EWGs). CVM experts are chairing four of the seven currently active EWGs:
1. Bioequivalence
2. Microbiological Acceptable Daily Intake
3. Pharmacovigilance
4. Safety.
The goals of VICH are to establish harmonised technical requirements for the registration or licensing of veterinary
medicinal products (i.e. protocols and testing standards for the studies that are required to show the safety, efficacy
and quality of veterinary medicines). VICH work also includes post-approval reporting requirements for adverse
drug events. The VICH membership includes regulatory and industry representatives from Japan, USA, European
Union, Canada, Australia and New Zealand. OIE, as an Associate Member, and the International Federation of
Animal Health, as the Secretariat, also participate in VICH.
VICH has developed over 40 guidelines covering the general subjects of quality, safety, good clinical practices,
anthelmintic efficacy, ecotoxicity, quality of biologicals, pharmaco-/vaccinovigilance, antimicrobial resistance, target
animal safety, metabolism and residue kinetics, and microbiological acceptable daily intake. Specific guidelines
on acute reference dose and bioequivalence are currently under development.
With encouragement from OIE to expand the number of countries and organisations working in VICH, the
Steering Committee formed the Global Outreach Working Group in 2009. The Working Group met in Washington,
DC, in October 2009 and in Paris in December 2010 and drafted a strategic plan to bring more countries and
organisations into VICH. The resulting VICH Global Outreach Conference has held two meetings so far, one in
Tokyo in 2011 and one in Brussels in 2012. In accord with OIE’s Fifth Strategic Plan to promote VICH guidelines
to all OIE Members, VICH representatives have participated in meetings of the OIE National Focal Points for
Veterinary Products held in Austria, Brazil, Cambodia, Colombia, Kenya, Morocco, Serbia and South Africa to
help introduce VICH to more countries in those regions of the world.
Benefits of harmonising international veterinary medicinal product
standards
The international standard-setting activities described here have a number of important benefits. Many of them
are obvious. They provide international venues for the exchange of concerns and issues of mutual interest among
industry, consumers and regulators; they provide fora for dealing with new, emerging global issues and relevant
sciences. Harmonised testing standards result in wider and faster availability of safe and effective veterinary
medicinal products, foods and feeds worldwide. Other benefits include reducing the costs of drug development
and reducing the need for animal testing. The VICH guidelines assure high product standards in terms of quality,
safety, and efficacy that protect public health, animal health and welfare, and the environment. Harmonised
requirements often update old standards by revising or replacing corresponding national/regional requirements.
International standard-setting procedures under the Codex Alimentarius, OIE, VICH, and other venues often
represent processes that are more transparent, cost-effective, and open for public scrutiny and comments. These
collaborative efforts are opportunities for highly experienced and qualified scientific experts to work together to
achieve a better understanding of regulations and related concerns. This work encourages a global product
development approach and a pooling of regulatory resources. It provides more regulatory certainty and reduces
impediments to trade in veterinary products and in animal-derived food products.
Difficulties involved in achieving international harmonisation of product
standards and testing protocols
While there are many potential benefits that flow from regulatory authorities developing and adopting internationally
harmonised standards and conformity assessment procedures, there are reasons why these standards are not

6. 40 OIE Global Conference on Veterinary Legislation
Session 1 The current state of play: the legislative landscape globally and regionally
always used. It is expected that scientific facts should apply universally around the world. Standards that are based
on science should be accepted by all countries. But scientific facts are not the sole determinant of regulatory
standards. Controls that assure the health and safety of consumers, even where those controls are based on
scientific fact, also represent national cultural norms. These norms reflect subjective values that are embodied
societal standards such as the consumer protection and health promotion laws of each country.
Consumer protection regulatory controls and procedures are sometimes similar, but many some differ significantly
across national boundaries. Differing value judgements that can affect the international harmonisation of science-
based product standards and testing protocols include the following:
−− the appropriate role of the government versus the role of the private sector in assuring product safety and health
−− the adequacy of resources available for public health and animal health protection
−− appropriate balancing of animal health protection and human health protection
−− appropriate balancing of trade interests and public/animal health interests
−− the proper level of scientific evidence required to prevent injury or harm compared with that required to
compensate for injury or harm
−− where the burden of proof lies when it comes to demonstrating product safety.
Science-based regulatory authorities
CVM and most other developed regulatory agencies base their decisions on science – very often stating that they
are a ‘science-based regulatory agency’ or that their ‘regulations are based on sound science’. What exactly does
this mean? Conceptually, decision making in modern product regulation is both science based and law based. But
it is difficult to integrate these two aspects of regulatory decision making because in many very fundamental ways
the scientific process and the legal process are very different and may even reflect incompatible methodologies.
The basic differences are summarised in Table I.
Table I A comparison of the scientific and legal decision-making processes
Scientific process Legal process
Truth seeking Decision seeking
Consensus development Adversarial
Relatively complete information Often incomplete information
Based on objective data Subjective or value laden
Timeliness is unimportant Timeliness is very important
In the scientific process or ‘scientific method’, the scientist is searching for ‘truths’ in the natural world. He or she
does this by building consensus among other scientists through open, transparent and free-wheeling dialogues
and collegial discussions among peers. Scientific agreement is primarily based on objective data that is empirical
and can be consistently reproduced through experimentation in which relevant variables are well controlled. The
scientific process is open ended; that is, the timeliness of the process is relatively unimportant. Some scientific
theories are discussed and debated for decades before consensus is reached, and then that consensus is always
open to future rebuttal or enquiry if additional relevant information is uncovered.
In contrast, participants in the legal process are seeking a decision, often under a specific time limitation. The
legal process is usually not described as collegial. Instead, it is often very adversarial with each side zealously
presenting only the evidence that supports his or her case or opinion. The time frame for making a decision is
usually very important. The issues underpinning legal decisions are predominantly based on subjective or value-
laden judgements rather than objective, reproducible data. Usually in the legal process, transparency is required
only when procedural rules demand it.
Within a ‘science-based regulatory agency’ there are situations in which decisions are made based on as much
objective information as exists at the time but where there is often incomplete or insufficient information to support a

7. OIE Global Conference on Veterinary Legislation41
The current state of play: the legislative landscape globally and regionally Session 1
purely ‘scientific’ conclusion. There is sometimes pressure to make regulatory decisions when conclusive evidence
does not exist. For regulatory agencies the determination to postpone a decision is nevertheless a decision. If the
regulator waits until there is absolutely no ambiguity in the evidence that supports a decision, unsafe products that
are already on the market may harm or continue to harm consumers. Conversely, delays in making a decision to
approve a product may keep safe products that promote health or cure disease off the market. Because of the
need to make a timely decision, many regulatory decisions have some amount of uncertainty associated with them.
The amount of uncertainty that is acceptable is clearly a value judgement and is therefore seen predominantly as
part of the legal process in regulatory decision making. But uncertainty also cannot be avoided when scientific data
are developed, so uncertainty is also part of the scientific process in making regulatory decisions. For example,
scientific uncertainties exist in extrapolating animal data to infer human health risks. Scientific uncertainties also
exist in determining the appropriate way of extending the dose–response relationship beyond the range of actual
empirical data. Scientific uncertainties exist concerning how to deal with ‘weight of evidence’ questions that
may arise from conflicting studies or when various studies are used collectively to support a decision. Scientific
uncertainties also exist concerning how to best represent risk assessment data in terms of statistical variance or
how to reflect the fact that studies (particularly biological studies) cannot be perfectly replicated.
Because regulatory actions are made using these two contradictory processes of science and law (often with many
overlapping elements), it is sometimes difficult for consumers and other stakeholders to understand the basis for
important health and safety decisions. One approach to better describe and communicate these complexities of
the regulatory decision-making process has been the general acceptance and use of the risk analysis paradigm.
Risk analysis: separation of risk assessment and risk management
Within their regulatory procedures, many agencies or organisations have very deliberately separated the science-
based elements of their decisions from other more value-laden elements. This approach was described by the
National Academy of Sciences/National Research Council in their 1983 pivotal report (1) entitled ‘Risk Assessment in
the Federal Government: Managing the Process’. The NAS/NRC report was one of the early recommendations that
considered risk assessment and risk management as separate processes. Under this approach, risk assessment
includes hazard identification, dose–response evaluation and analysis of exposure. The risk management process
includes value judgements such as considerations of data acceptability, feasibility of implementation, and economic
consequences. Since the early 1980s this risk analysis dichotomy has been widely espoused and accepted by
many authorities and structurally incorporated into the decision-making process of various regulatory agencies and
standard-setting organisations around the world. For example, EFSA was established to be the risk assessment
body to support food safety decisions within the European Union, with the European Commission’s DG SANCO
being the risk management body. Similarly, in Japan the Food Safety Commission is authorised to conduct risk
assessments, and MHLW and MAFF have the responsibility for developing and implementing risk management
options. Within the decision-making process of the Codex Alimentarius, risk assessments for pesticide residues,
food additives and veterinary drug residues are made by the Joint Meeting on Pesticide Residues and the Joint
Expert Committee on Food Additives, and risk management decisions are made by the Codex Committee on
Pesticide Residues, the Codex Committee on Food Additives, and the CCRVDF.
Alas, it would be nice if there was a clear dichotomy between the risk assessment process and the risk management
process. But there is not. As described above, uncertainty is unavoidable in most regulatory decision making.
What causes controversy with regard to uncertainty is deciding how much is appropriate or acceptable. Regulatory
decisions about product safety and animal and public health clearly incorporate societal value judgements and
are part of the risk management process but they also involve scientific judgements and are part of the risk
assessment process.
Attempts to separate risk assessment and risk management, while helpful for descriptive purposes, can actually be
counterproductive because they reinforce the false notion that risk assessment is ‘pure science’ and is free of values.
Professor Silbergeld (2) argues that ‘both science and policy could be better served by recognizing the scientific
limits of risk assessment methods and allowing scientific and policy judgment to interact to resolve unavoidable
uncertainties in the decision-making process.’ She further argues that ‘separating … decision-making into risk
assessment and risk management encourages misinterpretations of uncertainty that discourage management
action. Within the culture of a regulatory agency, this justifies a separation of activities that is deleterious to sound
operations and a sense of shared institutional authority and responsibility. When the scientists are restricted

8. 42 OIE Global Conference on Veterinary Legislation
Session 1 The current state of play: the legislative landscape globally and regionally
from access to policymaking processes based on the implications of scientific choices …, they can only guess
how their choices may affect policy. And when policymakers, encouraged to remain ignorant of science, may
misinterpret uncertainty …’.
Conclusion
What does all of this mean for the international harmonisation of product standards and conformity assessment
procedures? When scientists collaborate to seek agreement on issues representing relatively pure science,
consensus is very often easily achieved. However, when these discussions move beyond scientific issues and
seek agreement on parts of the regulatory decision-making process that embody societal values and subjective
judgements – whether these are seen as part of risk assessment or part of risk management – they become more
contentious and are often difficult to resolve. National legislation and regulation covering consumer safety and
health often reflect different societal values. This is particularly frustrating because in the end most nations agree
on the overall goals of effective product regulation – that is, to have available safe and effective medicines and
safe foods. National regulatory agencies must all work more creatively to bridge the gap between their agreement
on the scientific objective data that exist to support product approvals and their agreement on the overall goals
of having the benefits that safe and effective products provide (Fig. 1).
Objective data
(science-based studies)
Final goals (safe and effective
medicines and safe foods)
Agreement is often
easily achieved
More work is needed to reach
agreement on, or harmonise,
many of the value judgements
related to risk management
Agreement is
universally accepted
Fig. 1 Bridging the gap between the scientific basis for regulation and the ultimate goals of regulation
Again, everyone wants safe and effective veterinary medical products to be available more widely and more quickly
and there is also much agreement on the objective science that underlies good regulation. The key to getting
from the science to the final goals is to obtain more agreement on the subjective elements or the societal value
judgements that permeate regulatory decision-making processes. This can be extremely difficult because the
differences in these values often reflect the differences in the various social behaviours seen around the globe.
Nation states may have originally arisen out of geographic and physical boundaries or from historical events
such wars, but the cultural norms of societies are probably the essence of what binds nations together today
and makes them differ from one another. So attempts to harmonise values related to important health and safety
standards across national boundaries have been and will remain difficult.
Attempts to portray value judgements as objective scientific fact will frustrate the achievement of clear understanding
and trust by all those individuals and organizations that have a stake in the regulatory process and in regulatory
outcomes. This is true whether these attempts are made at the national level by regulators or at the global level
as part of negotiations to reach international consensus on product standards. It has been argued that regulatory
decision makers should not try to separate cleanly objective elements of the standard-setting process from value
judgements and that such a dichotomy can even be counterproductive for regulators and for promoting an
understanding by consumers and other stakeholders of the bases of regulations. This does not mean, however,
that efforts to more clearly separate and identify the objective data and the subjective, value-laden judgements
should not be undertaken wherever possible. Such transparency is the most important key to bringing forward
credible regulatory decisions at both national and international levels and regulatory controls that will ultimately
be understood and respected by all stakeholders.
In addition to transparency, it should be emphasised that all levels of government need to be a part of both national
and international health and safety standard-setting efforts. This means that our ‘political masters’ have to play
an active and informed role in all of our attempts to harmonise veterinary product standards. The scientists and
technocrats who participate in these harmonisation activities cannot alone make the value-laden decisions that
must to be made to achieve harmonisation of regulatory standards and procedures. Our politicians must be kept
informed and be actively involved and supportive at every step in the process of developing regulatory standards.

9. OIE Global Conference on Veterinary Legislation43
The current state of play: the legislative landscape globally and regionally Session 1
The benefits for human and animal health and safety of harmonising product standards globally are enormous.
We need to continue to work hard at every level to achieve these important goals.
References
1. National Academy of Sciences/National Research Council (NAS/NRC) (1983). – Risk Assessment in the Federal
Government: Managing the Process. NAS Press, Washington, DC.
2. Silbergeld E.K. (1991). – Risk assessment and risk management: an uneasy divorce. In Acceptable Evidence:
Science and Values in Risk Management (D.G. Mayo R.D. Hollander, eds). Oxford University Press, Oxford, UK,
99–114.