This chapter maps the corpus of normative instruments developed by the OIE, outlines the organisational structure supporting its normative activity, and describes the process of implementation of OIE standards. It finds that the OIE develops different voluntary normative instruments, commonly referred to as OIE international standards, which are recognised as reference standards in the areas of animal health (including zoonoses) and animal welfare. The Codes and Manuals, which are the core normative instruments of the OIE, are developed following a largely expert-driven and participatory standard-setting procedure. However, despite their recognised usefulness by OIE Members, evidence on the actual uptake of OIE standards in domestic legislation remains scarce, reflecting uneven process for their domestic application and inconsistent monitoring of their use. The implementation process is neither defined nor prescribed by the OIE, and Members have much leeway in considering, referencing and using OIE standards.
OECD Study on the World Organisation for Animal Health (OIE) Observatory
1. Characterisation of the body of OIE normative instruments
Abstract
The OIE aims to ensure the improvement of animal health and welfare, and veterinary public health worldwide, strives to prevent the spread of diseases, and inspire trust in veterinary services. To do so, the OIE provides a comprehensive framework to support Members to achieve three interrelated objectives:
to establish transparency on the sanitary status of animal diseases for country, zone or compartment;
to build good governance of the national animal health and welfare systems through improved legal frameworks and resources of veterinary services;
to support world trade in animals and animal products by ensuring safety, while avoiding unjustified sanitary barriers.1
To achieve its objectives, the OIE adopts a number of voluntary normative instruments for use by its Members, commonly referred to as OIE’s international standards (Box 1).2 The purpose of the OIE’s international standards is to improve the health and welfare of animals throughout the world, regardless of socio-economic, religious or cultural context.
Box 1. What is an international standard?
(OECD, 2019[1]) highlights the wide range of instruments with external normative value adopted by international organisations, most of which non-legally binding. Among them, “international technical standards are voluntary instruments developed in response to a need in a particular area expressed by stakeholders through a bottom-up approach” (OECD, 2016[2]). They may be incorporated by states within their domestic legislation and/or directly implemented by private actors, which perceive their quality and relevance.
There is no recognised definition of international standards. Nevertheless, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) of the World Trade Organization (WTO) bases their qualification on whether they come from three international bodies, including the World Organisation for Animal Health in relation to international standards for “animal health and zoonoses” (OECD/WTO, 2019[3]).
Source: (OECD, 2016[2]), International Regulatory Co-operation: The Role of International Organisations in Fostering Better Rules of Globalisation, Paris, https://dx.doi.org/10.1787/9789264244047-en; (OECD, 2019[1]), “The Contribution of International Organisations to a Rule-Based International System”, Paris, www.oecd.org/gov/regulatory-policy/IO-Rule-Based%20System.pdf; (OECD/WTO, 2019[3]), Facilitating Trade Through Regulatory Co-operation: The Case of the WTO’s TBT/SPS Agreements and Committees, Paris, Geneva, https://doi.org/10.1787/ad3c655f-en.
The OIE adopts five different kinds of voluntary normative instruments for use by OIE Members (Figure 1.1):
Codes (Terrestrial Animal Health Code, or Terrestrial Code, and the Aquatic Animal Health Code, or Aquatic Code);3
Manuals (Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, or Terrestrial Manual and the Manual of Diagnostic Tests for Aquatic Animals, or Aquatic Manual);4
Technical resolutions;
Recommendations;
Guidelines.
There is a specific use case of “technical resolutions” by which the OIE issues official recognition of disease status of countries for terrestrial diseases and the list of antimicrobial agents. They can both be considered as normative statements by the organisation and the outcomes of implementation of relevant sections of the OIE Terrestrial Code (hence their short description below and further development in the Chapter on Existing mechanisms supporting and monitoring the implementation of OIE standards).
The organisational setting of the OIE (Figure 1.2) is structured in a manner to ensure a high level of scientific evidence-base and regional representativeness in the development of these normative instruments, as well as follow-up support at the regional and country level in the implementation of the instruments. The “World Assembly of Delegates” is the highest authority of the OIE that meets for its General Session every year in May.5 The OIE has a Secretariat headquartered in Paris, France, as well as regional offices, tasked with the administrative management of the organisation and in charge to support the work of the experts.
Finally, the implementation of OIE normative instruments (Figure 1.3) pertains to OIE Members. Nevertheless, the OIE provides some guidance and indications on the possible forms of implementation of OIE standards at the domestic level.
Overview of OIE normative instruments, focus on explanation of OIE Codes and Manuals
Figure 1.1 gives an overview of the OIE normative instruments that apply to OIE Members and the dynamics between them. Overall, the “core” standards developed by the OIE are the Codes and Manuals. Updates to these Codes and Manuals are adopted by Resolutions of the OIE World Assembly. In addition, for specific purposes, the Codes and Manuals are complemented by:
Technical resolutions for official recognition of disease status and for endorsement of national official control programmes or Technical resolution on list of antimicrobial agents of veterinary importance;
Technical resolutions adopted by the World Assembly following the presentation of technical items during General Sessions;
Recommendations of Regional Commissions, submitted to the World Assembly for approval;
Recommendations of Global Conferences, which may be presented to the World Assembly for information but not for endorsement;
Guidelines developed by specialists and published on the OIE website.
Figure 1.1. Overview of OIE normative instruments
Notes: This figure focuses on instruments directed at OIE Members. It does not picture the OIE instruments that are internal administrative documents.
Source: Author’s own elaboration based on OIE responses to OECD 2018 survey to international organisations.
The core of OIE instruments: Codes and Manuals
The Codes and Manuals represent the largest volume of normative work of the Organisation, are applicable to all OIE Members, and are the only ones that are subject to monitoring of implementation.
The Terrestrial and Aquatic Codes set principles to ensure the quality of veterinary services/aquatic animal health services, definitions of diseases, as well as the conditions to confirm that diseases are absent. In particular, they compile a number of international standards that contain “science-based recommendations for disease reporting, prevention and control and for assuring safe international trade in terrestrial animals (mammals, reptiles, birds and bees) and aquatic animals (amphibians, crustaceans, fish and molluscs) and their products” (OIE, 2016[4]). The OIE Codes are structured between horizontal chapters with general provisions dealing with veterinary systems and disease-specific chapters.
OIE Manuals apply to diagnostic laboratories and vaccine production, and aim to provide a uniform approach to the detection of diseases listed in the Codes. They set standards on the management of veterinary diagnostic laboratories and vaccine facilities and on the methods for validation of diagnostic tests and for the manufacture of vaccines. In addition, the main part of the Terrestrial Manual sets standards for diagnostic tests and vaccines mainly for specific diseases listed in the Codes as having potential for very serious and rapid spread, irrespective of national borders.6 They therefore apply to a specific set of activities and are of use for a more limited number of domestic authorities, most directly to the laboratories carrying out veterinary diagnostic tests and surveillance and vaccine manufacturers and users.
The structures and contents of the Codes and Manuals respectively are similar for both Terrestrial and Aquatic animals, with differences mainly related to the subject matter.
OIE normative instruments complementing Codes and Manuals
In complement to the Codes and Manuals, the OIE also adopts other instruments: namely resolutions, recommendations or guidelines. Overall, their objective is to complement the Codes and Manuals with more specific guidance either applicable to a regional context or to a specific thematic need.
Technical resolutions are the normative instrument of the World Assembly of Delegates that serve as a formal adoption by the entire Membership of documents developed by Specialist Commissions, or by the OIE in specific contexts. In particular, technical resolutions serve to formally adopt: technical items of the WAD (World Assembly of Delegates), developed by the OIE; the list of OIE Members and zones with disease-free status officially recognised by the OIE; as well as the OIE list of antimicrobial agents of veterinary importance.
Recommendations may be adopted either at the regional or at the global level. At the regional level, recommendations are developed by the Regional Commissions, on issues relevant to their respective regional interests. The recommendations are discussed and elaborated during a Regional Conference convened by the OIE Director-General every two years. The recommendations are then integrated into a report of the Regional Commission submitted to the General Session of the “World Assembly of Delegates” for approval.7
At the global level, recommendations may be adopted by the participants (that may include Member countries, experts, donors, etc.) of a Global Conference, organised on a specific topic on an ad hoc basis. Recommendations are drafted by the OIE Secretariat based on information shared and discussed during the global conference. Participants are left with time for comments, during dedicated sessions in the Global conference, and for a period after the meeting. After this, the OIE Secretariat posts the recommendation to its website. The recommendations of the Global Conferences are shared with the World Assembly of Delegates in May, for information, not for endorsement.
Guidelines are developed by the specialists designated by the OIE secretariat and published on the OIE website without following a systematic pre-established procedure. They are not endorsed by the World Assembly of Delegates. They are developed to provide guidance on a specific topic, often in complement of existing standards in the OIE Codes or Manuals. The name of such documents may vary, namely guidelines, checklists or tools.
As an example of such documents, the Checklist on the Practical Application of Compartmentalisation supports veterinary authorities and private sector in interpreting and complying with OIE standards from the Terrestrial Code, which establishes the principle of compartmentalisation. It therefore sets six broad principles that go from the definition of a compartment the separation of a compartment from potential sources of infection, and surveillance for the agent or disease, to emergency responses and notifications as well as supervision and control of compartments. Other examples of guidelines include the Guidelines for Animal Disease Control (OIE, 2014[5]), the Guidelines for Investigation of Suspicious Biological Events (OIE, 2018[6]) and the Guidelines on the Veterinary Education Core Curriculum (OIE, 2013[7]). The PVS Tool for the Evaluation of Performance of Veterinary Services (OIE, 2019[8]), although not formally classified as such, operates and has similar status to OIE guidelines.
In addition to these instruments which apply to OIE Members, the OIE also adopts instruments that are rather directed at the OIE Secretariat, for administrative purposes (e.g. administrative resolutions), for staff and organisational purposes (Codes of conduct), or for setting co-operation objectives with other international bodies (Memoranda of Understanding, MoUs). These MoUs are not so much normative instruments directed at OIE Members, but rather agreements with other international organisations or non‑governmental organisations.8 Resolutions may be adopted for internal administrative purposes or with an effect for all OIE Members.
Sui generis OIE normative instrument: Official Recognition of Disease Status and the OIE List of antimicrobial agents
In addition to these families of instruments, the OIE develops two forms of sui generis normative instruments, on the basis of provisions of the Codes and Manuals, formally adopted by technical resolutions of the General Assembly. This is the case for Official Recognition of Disease Status and of the OIE List of antimicrobial agents of veterinary importance.
The “Official Recognition of Disease Status” issued by the OIE, and the related endorsement of national official control programmes, provides a unique form of normative instrument in support of the implementation of the OIE Terrestrial Code and Manual. Following an in-depth procedure to verify the compliance of OIE Members’ with certain standards of the Terrestrial Code and Manual (described further below), the Official Recognition of Disease Status results in a normative document adopted by the World Assembly of Delegates via a technical resolution (see Box 3.3). The Official Recognition of Disease Status thus serves both as a statement of compliance with OIE Terrestrial Code and Manual and as a standalone normative document in itself.
The OIE List of antimicrobial agents of veterinary importance was first established by the OIE, following a call by an expert workshop on Non-Human Antimicrobial Usage and Antimicrobial Resistance between the FAO/OIE/WHO in 2003. It is a normative document serving as a reference on all antimicrobials that are important in veterinary medicine. The list was initially developed by an ad hoc group on antimicrobial resistance, followed by a survey questionnaire sent by the OIE Director General to all OIE Members. It is regularly updated – the latest update took place in May 2018 (OIE, 2018[9]).
OIE organisational structure supporting its normative activity
Given the highly technical nature of the OIE mandate and normative activity, the OIE governance structure reflects an expert-driven organisation. A substantive part of OIE normative activity is carried out by several groups bringing together experts from Member countries to continuously monitor the evolutions of scientific information on epidemiology and ensuring a science-based standard-setting process. In addition, similarly to other intergovernmental organisations, the OIE provides several platforms for its Members to meet regularly, both to provide strategic leadership (World Assembly of Delegates; Council), as well as to ensure close contact with regional specificities (Regional Commissions). The OIE Secretariat provides institutional support to OIE Members in these different groups. Figure 1.2 describes these three different types of organs.
The expert-driven nature of the OIE is particularly apparent throughout the standard-setting procedure of the OIE Codes and Manuals, which go through a thorough multi-layered process between experts and OIE Members. This confirms the highly technical nature of OIE Codes and Manuals, as well as their significance in the overall body of instruments of the OIE.
Figure 1.2. Organs involved in the conduct of OIE work
Notes: Author’s own elaboration. This figure describes the existing organs involved in the conduct of OIE work. It does not prejudge any hierarchy between the organs.
Source: www.oie.int/about-us/wo/.
Overview of OIE organisational structure
The OIE is structured around direct representations of OIE Members, giving the strategic leadership to the organisation; groups of experts, conducting the core of the standard-setting work of the organisation; as well as the OIE Secretariat, supporting the Members and experts. Specific representations of the Organisation is provided at the regional level to ensure the inclusiveness of the OIE work with all OIE Members.
The OIE is led by a World Assembly of Delegates (WAD) bringing together delegates from veterinary authorities of all OIE Member countries once a year in May. The WAD has the authority to review and endorse normative instruments, and in particular Codes and Manuals. The WAD is supported by the Council, composed by a sub-set of nine elected Members from OIE Member countries, representing all regions and meeting at least twice a year in Paris.9
Under the leadership of these organs, which represent the entire Membership, the core of the organisation’s standard-setting is conducted by different specialised groups of experts, ensuring that the different normative instruments are state of the art and evidence‑based. Specialist Commissions are namely the bodies that have oversight over the standard-setting process. There are four Specialist commissions10 that meet on a regular basis, and may propose to the OIE Director-General to convene an ad hoc group or one of the permanent working groups11 for the development of certain standards, as described in Figure 1.4.
Collaborating Centres and Reference Laboratories allow to provide expert support to OIE Members on specific topics. The Collaborating Centres are networks of experts set up to provide expertise on specific topics of competence in some cases for particular regions,12 and may be solicited when experts are needed, for example for constituting ad hoc groups. The Reference Laboratories provide scientific and technical advice on diagnosis and control of specific diseases.13
In addition, a number of regional groups are set up to ensure that the interests and needs of specific regions and countries are well reflected in the multilateral setting. Regional commissions meet at the regional level and reconvene their respective positions and priorities to the WAD at the annual meeting.
Finally, the everyday work of the OIE is carried out by a relatively small secretariat in comparison with other intergovernmental organisations, composed of 163 people.14 It is nevertheless in line with other standard-setting bodies (e.g. ASTM – 200; IEC – 110; IFAC – 79; ISO – 136) (OECD, 2016[2]). The work of this secretariat consists in supporting the various expert groups, facilitating the development and implementation of OIE standards, and more broadly, helping OIE Members ensure implementation of the Organisation’s mandate and strategic plans.
The Secretariat functions under the general leadership of the Director-General, who, with the support of two Deputy Directors General and a Financial Director provides a transversal vision of the work of the organisation. It is under the responsibility of the Director-General that a five-year Strategic Plan is set, in close collaboration with the OIE Council. This Plan builds on latest scientific and governance advances and results of previous strategic plans and ensures that the OIE continues to contribute effectively to societal changes.15
The more technical work of the organisation is conducted by units under the authority of the two Deputy Directors General, who head two “pillars” of work (see Figure 1.3: i) institutional affairs and regional activities; and ii) international standards and science. The first pillar deals with organisational governance, communications, legal affairs, governance of the Veterinary Services (through the Performance of Veterinary Services Pathway), Member support (including capacity building) and strategic co-operation. The second pillar focuses on substantive matters, which are conducted by individual units, such as WAHIS (World Animal Health Information System), standards, status, programmes, anti-microbial resistance and veterinary products, science, and publications.
To ensure regional representativeness, the work of the headquarters is complemented by work of regional representations, involving offices of the OIE Secretariat based directly in Africa, Americas, Asia and the Pacific, Europe, Middle East.
Figure 1.3. OIE 2019 organisational chart
Source: Information provided by the OIE
Conduct of OIE normative activity
The standard-setting procedure for the OIE Codes and Manuals is the most rigorous and formal procedure within the OIE normative activity together with the specific procedure for the official recognition of disease status. The other normative instruments are developed on a more ad hoc basis and organically.
The Codes are developed following the procedure described in Figure 1.4. The standard‑setting procedure starts with a proposal for a new or revised standard, following a topic, issue, problem identified by a Member country, a specialist commission, or an international/regional organisation with whom the OIE has an official agreement. The proposals for a new or revised standard are included in the work programmes of Specialist Commissions.16 Depending on the specific needs of the standard, the Specialist Commissions may suggest to use the expertise of an ad hoc Group (convened at the initiative of the Director General) or of one of the permanent Working Groups of independent experts (formed by decision of the World Assembly of Delegates upon recommendation of the Director General).
At each February and September meetings, the Specialist Commissions review the drafts and share with OIE Members for comments, and review the comments (or revert back to experts as relevant). Normally, there are at least two review cycles (over two years) between Specialist commissions and permanent working groups or ad hoc groups to leave time for Members to become acquainted with the draft, comment on it, and facilitate consensus-based adoption by the World Assembly of Delegates. Once the final draft is agreed upon, the relevant specialist commission shares the draft text with all OIE Members in March, two months in advance of the World Assembly of Delegates. This leaves OIE Members two months to examine the final drafts before eventually adoption by consensus in the World Assembly of Delegates in May (OIE, 2016[4]).
This same procedure is followed for both Terrestrial and Aquatic Codes. Nevertheless, the public authorities in charge of setting aquatic and terrestrial animals may be different. The engagement of the authorities on Terrestrial and Aquatic standards is therefore not systematically the same, whether in the standard-setting process or in the implementation of standards. As a result, the engagement in the development of aquatic standards is sometimes considered less active.
In principle, Manuals follow a very similar procedure as the Codes. They are however rarely developed through ad hoc or permanent working groups in practice, but rather by Reference Laboratory experts and the Biological and Aquatic Specialist Commissions. In addition, they usually go through only one review cycle, instead of two review cycles usually followed for OIE Codes.
This procedure is specific to the OIE standards, and differs from the procedure followed to set other OIE normative instruments. In particular, Administrative decisions related to the operation of the OIE (Administrative Resolutions) are developed in consultation with the OIE Council and adopted by OIE Member countries during the World Assembly. Technical Resolutions related to the Technical items are developed with the support of the Rapporteur and voluntary Member Countries during the General Session of the World Assembly. Recommendations of Regional Commissions are developed during Regional Conferences.17
Figure 1.4. Yearly standard-setting procedure for OIE Codes and Manuals
Source: Author’s own elaboration based on (OIE, 2016[4]), Procedures used by the OIE to set standards and recommendations for international trade, with a focus on the Terrestrial and aquatic animal health codes, http://www.oie.int/fileadmin/Home/eng/Internationa_Standard_Setting/docs/pdf/A_OIE_procedures_standards_2016.pdf.
Implementation of OIE normative instruments
OIE normative instruments are voluntary for OIE Members, even though their use is strongly incentivised by the WTO SPS Agreement (see below). In OIE normative framework, the only obligation for OIE Member countries is to notify disease status and disease control measures, in virtue of the Organic Statutes of the OIE.18 This notification obligation was later embedded in the Terrestrial and Aquatic Codes. The voluntary nature of OIE normative instruments has several consequences, namely:
OIE Members may adopt and use the instruments in a manner that is most relevant to their specific conditions, such as their disease status, domestic regulatory framework, etc. In particular, all OIE normative instruments may not be relevant to all countries;
OIE Members may choose a higher level of protection than those in the OIE instruments if they have a scientific justification. This is acknowledged by the WTO SPS Agreement (art. 3.3). Certain standards in the OIE Codes provide specific methodologies on risk analysis, which may help OIE Members in providing such scientific justification while respecting OIE standards.
Like for international instruments more broadly, the process for implementing OIE standards is not easily defined (Box 1.2). Neither the OIE, nor another source of international law (WTO requirements for example) define specifically a preferred path or specific modalities for their implementation, or prescribe the approach to adopt. As a result, there is a wide variation of implementation practices across OIE Members.
Still, a number of provisions of the OIE Codes and Manuals provide guiding language to support OIE Members in their efforts to implement specific technical aspects of OIE standards. This is in line with the common practice of international organisations - two thirds of IOs surveyed by the OECD as part of its work on international rulemaking report providing a description of implementation in their instruments themselves (OECD, 2019[1]). The WTO SPS Agreement also includes provisions promoting the uptake of OIE standards in veterinary legislation of OIE Member countries.
Box 1.2. Defining implementation
In common language, implementation is defined as “The process of putting a decision or plan into effect; execution”.1 In a legal context, this corresponds to putting a law into effect. In domestic law, implementation of a law typically entails that a regulatory agency issues an administrative regulation specifying how the law is going to enter into effect and how citizens must comply with it.2
The definition of implementation of international instruments is particularly difficult. Broadly speaking, normative instruments developed by international organisations need to be adopted or used domestically to have a legal and practical effect. The ways in which this is done depends on each countries’ constitutional systems, and is often done without any involvement of IOs. Nevertheless, IOs may track the use of their instruments, and provide related support and guidance to their Members to implement them (OECD, 2019[1]).
The voluntary nature of international instruments entails that domestic regulatory authorities maintain a certain leeway in the interpretation and adaptation of the international text to the domestic context. The international nature of these standards entails that the implementation processes vary according to different legal systems.
Overall, a broad notion of “implementation” of voluntary international standards has two components: i) the de jure incorporation/ application of an international standard in domestic legislation, and ii) the de facto use made of the international standard in practice, either in the inspection and enforcement processes or by private companies in their production process (Combacau and Sur, 2016[10]). This same distinction is reflected by ISO’s understanding of implementation:
“A normative document can be said to be “implemented” in two different ways. It may be applied in production, trade, etc., and it may be taken over, wholly or in part, in another normative document. Through the medium of this second document, it may then be applied, or it may again be taken over in yet another normative document.”3
The de facto use made of international standards entails the actual application of the standard by its end-users. Evidence of such use is usually harder to monitor by IO Secretariats, who are rarely in contact directly with citizens or economic actors.
The de jure component of implementation is defined by ISO as the adoption or taking over of an international standard in a national normative document.4 This implementation of international standards into domestic legislation depends on each country’s domestic procedures. While supposedly easier to track (given the transparency requirements related to domestic laws and regulations), the de jure adoption of international standards in domestic legislation may take different forms (by reference to an international standard or a domestic standard reflecting international practice, by partial or complete text transcription…) and involve various degree of conformity with the international instrument that complicates its monitoring.
1 Oxford dictionary https://en.oxforddictionaries.com/definition/implementation.
3 ISO ISO/IEC Guide 2:2004 10.
4 ISO ISO/IEC Guide 2:2004, 10.1.
Source: (OECD, 2019[1]), http://www.oecd.org/gov/regulatory-policy/IO-Rule-Based%20System.pdf; (Combacau and Sur, 2016[10]), Droit international public, LGDJ-Lextenso, https://www.lgdj.fr/droit-international-public-9782275045092.html (accessed 12 September 2018).
Implementation how?
The OIE Codes include a user’s guide, guiding OIE Members in the use of the Codes. This user’s guide specifies that the Codes should be used by competent authorities “to set up measures”:
User’s Guide of the Terrestrial Code: “Veterinary Authorities should use the standards in the Terrestrial Code to set up measures providing for early detection, internal reporting, notification, control or eradication of pathogenic agents, including zoonotic ones, in terrestrial animals (mammals, birds, reptiles and bees) and preventing their spread via international trade in animals and animal products, while avoiding unjustified sanitary barriers to trade.”19
User’s Guide of the Aquatic Code: “Competent Authorities should use the standards in the Aquatic Code to develop measures for early detection, internal reporting, notification, control or eradication of pathogenic agents in aquatic animals (amphibians, crustaceans, fish and molluscs) and preventing their spread via international trade in aquatic animals and aquatic animal products, while avoiding unjustified sanitary barriers to trade.”20
In other words, the implementation of OIE standards require domestic legislation that should provide a basis for Competent Authorities to develop sanitary measures. Therefore, when implementing OIE standards, OIE Members give a legal effect at the domestic level to the conditions set at the international level by incorporating the standard in any domestic text, whether law, regulation or other normative act.
In addition, the OIE also provides various tools to assist Members in the development of sanitary measures, and the use of OIE standards in this context. These are mainly targeted guidelines on the implementation of specific standards.
In particular, the OIE has established guidelines for veterinary legislation,21 which were subsequently adopted as standards in Chapter 3.4 of the Terrestrial Code, to assist Members in the implementation of OIE standards, for terrestrial animals, in the development of SPS measures. The relevant Code provisions establish general principles on the form, content and objectives of veterinary legislation. Among others, they recommend that OIE Members designate competent authorities to develop veterinary legislation following the OIE definition to do so, to hold an inventory of veterinary legislation and make it “… readily accessible and intelligible for use, updating and modification, as appropriate” (art. 3.4.3 Terrestrial Code ). These recommendations apply to veterinary legislation in general and as such do not prescribe conformity with OIE standards, which remain voluntary. They do not explicitly provide any guidance on how to incorporate international standards into the veterinary legislation. However, several references are made to the OIE, including in the article 3.4.13 on technical recommendations on the legislation concerning import and export procedures and veterinary certification. This article recommend that veterinary legislation “should provide a basis for actions to address the elements relating to import and export procedures and veterinary certification referred to in Section 5.”
Other guidance is provided for example in certain chapters of the terrestrial and aquatic Manuals, which set out procedures to be followed by laboratory workers in the control of vaccines or laboratory diagnosis of diseases. In addition, a specific set of guidelines is developed for the implementation of disease control programmes, in order to create an enabling regulatory and institutional environment for the eradication of a disease (OIE, 2014[5]). For examples of such guidance provisions, see Box 1.3.
Box 1.3. Examples of implementation guidance within OIE standards
A number of provisions developed by the OIE contain guidance on implementation of specific provisions of the OIE Codes or Manuals.
Introduction of the Terrestrial Manual:
“Each disease chapter includes a summary intended to provide information for veterinary officials and other readers who need a general overview of the tests and vaccines available for the disease. This is followed by a text giving greater detail for laboratory workers. In each disease chapter, Part A gives a general introduction to the disease, Part B deals with laboratory diagnosis of the disease, and Part C (where appropriate) with the requirements for vaccines or in vivo diagnostic biologicals. The information concerning production and control of vaccines or diagnostics is given as an example; it is not always necessary to follow these when there are scientifically justifiable reasons for using alternative approaches. Bibliographic references that provide further information are listed at the end of each chapter.”
Introduction to the Aquatic Manual:
“The general provisions and disease-specific recommendations of the Aquatic Manual together provide technical information to support implementation of standards contained in the OIE Aquatic Animal Health Code (Aquatic Code). These standards include Member countries’ obligations to report the occurrence of listed diseases; requirements to demonstrate freedom for a country, zone or compartment; requirements for responding to the occurrence of a disease; and requirements to return to freedom following a disease outbreak. The recommendations in the Aquatic Manual and the Aquatic Code are intended to be complementary and both documents should be used together when developing or undertaking surveillance activities in accordance with OIE Standards.”
Source: (OIE, 2014[5]), Guidelines for Animal Disease Control, http://www.oie.int/fileadmin/home/eng/our_scientific_expertise/docs/pdf/a_guidelines_for_animal_disease_control_final.pdf.
Beyond these guidance documents, however, the OIE does not promote a specific approach to the adoption of its standards in domestic legislation, leaving it to the specificity of each institutional framework. For example, it does not specify the form of legislation to be used (primary, secondary, or tertiary legislation). The choice of the form of legislation may have implications on the formality of the national measure, as primary legislation has a stronger legal stance, but implies debates in national parliaments and may thus result in a text quite different from the international standard. Secondary legislation is more technical, developed usually by the executive body or independent authorities, and may be easier to monitor. De facto, analytical work by the OIE on trade of aquatic animals and aquatic animal products shows that sanitary measures take different forms in countries (Figure 1.5). The OIE does not specify either the format of the reference to the OIE standard, leaving countries to choose for example between literal transposition of OIE standard, dated or non-dated reference to a specific standard, or copying of relevant language of the standard.
Figure 1.5. Classification of notified legislations according to their ranking in the hierarchy of legislation and their objective
Note: This schematic diagram was developed on the basis of the analysis of 148 legislations notified to WTO between 2007 and 2018.
Source: (Bucher, Tellechea and Mylrea, 2019[11]), “Safe trade of aquatic animals and aquatic animal products: exploring the use of OIE international standards for setting sanitary measures”, OIE Scientific and Technical Review, Vol. 38/2.
The WTO SPS Agreement provides additional international commitments binding in the WTO legal order, requiring the use of OIE standards by WTO Members except where a higher level of protection is justified based on scientific justification/risk assessment.22 In this context, the SPS Agreement envisages different levels of compliance of domestic regulations with international standards (see Box 1.4). However, beyond the text of the agreement, the WTO does not provide additional guidance to regulatory authorities on the practical approach to follow when considering international standards.
Box 1.4. Levels of implementation with international standards in WTO SPS Agreement
The WTO SPS Agreement envisages that for the purpose of complying with the WTO obligation of harmonisation, there are several levels of compliance with international standards:
SPS measures “based on” international standard, i.e. reference to international standard in national legislation, regulations, etc. (art. 3.1 SPS Agreement). “Such a measure may adopt some, not necessarily all, of the elements of the international standard.”1
“Conformity” with international standard, i.e. identical transcription of international standard in text of national measure. “such a measure would embody the international standard completely and, for practical purposes, converts it into a municipal standard”.2 Measures which conform with international standards are “… deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994” (art. 3.2 SPS Agreement).
Deviation from international standard: the WTO SPS Agreement also recognizes the possibility for WTO Members to adopt a level of protection higher than that embedded in an international standard, if it is justified by scientific evidence, or justified by a risk assessment (art. 3.3 and art. 5 SPS Agreement).
These categories introduce a notion of variation in the levels of consistency between national measures and international standards. However, they remain broad and do not provide concrete guidance on assessing the degree to which domestic SPS measures are based on OIE standards or take them into account.
1 The Appellate Body clarified that there is no “rule-exception” relationship between the three scenarios for the purposes of WTO law. Appellate Body Report, EC – Hormones, para. 104. In other words, for the purpose of complying with their WTO obligations, Members have the autonomy to choose the extent to which they base their SPS measures on international standards. Nevertheless, the wording of the agreement encourages Members to implement SPS measures which conform to international standards.
2 Appellate Body Report, EC Measures Concerning Meat and Meat Products (Hormones), WT/DS26/AB/R, WT/DS48/AB/R, adopted 13 February 1998, DSR 1998:I, p. 135. See Spec. para. 170 et seq.
In practice, OIE Members’ veterinary authorities consult existing OIE standards when developing draft measures related to animal health or safety (Kahn, 2018[12]). If the OIE standard is considered relevant for their country, the veterinary authorities may make an explicit reference to OIE standards broadly in the preamble of the document, and use the text of the relevant OIE standard to develop the national measure, adapting it as necessary. The reference to the OIE standards does not always specify the exact standard that is used as a basis, in case the standard still evolves. In some cases, some countries chose to make a dated reference to an OIE standard, to clarify the version used for the particular text. Annex A provides insights into how countries typically embed OIE standards in their legislation, based on a questionnaire developed as part of a specific thematic item 1, for 86th General Session of the World Assembly of Delegates.
Implementation by whom?
In line with common IO practice, implementation of OIE standards is a shared responsibility between Members and the Secretariat (OECD, 2019[1]). The OIE Members are responsible for setting up the right measures within their domestic legal framework to reflect the OIE standards agreed on internationally, whereas the OIE Secretariat provides support and guidance to foster consistent understanding of OIE standards among its Members.
At the country level, the uptake of OIE standards into domestic legislation falls under the responsibility of the authorities tasked with the regulation of animal health and welfare. The OIE Glossary of the Terrestrial Code defines competent and veterinary authorities as follows:23
“Competent authority”: means the Veterinary Authority or other Governmental Authority of a Member Country having the responsibility and competence for ensuring or supervising the implementation of animal health and welfare measures, international veterinary certification and other standards and recommendations in the Terrestrial Code and in the OIE Aquatic Animal Health Code in the whole territory.
“Veterinary authority”: means the Governmental Authority of a Member Country, comprising veterinarians, other professionals and paraprofessionals, having the responsibility and competence for ensuring or supervising the implementation of animal health and welfare measures, international veterinary certification and other standards and recommendations in the Terrestrial Code in the whole territory.
The OIE 2018 questionnaire for technical item 1 of the 86th General Session indicates that the large majority of OIE Members have designated not one but several competent authorities in their country for developing sanitary measures to support market access (Figure 1.6). Nevertheless, in 93% of cases, a veterinary authority is involved, underlying consistency across countries’ institutional frameworks likely to facilitate discussion and data collection between the secretariat and Members. In many cases, a variety of other authorities is still involved. This may require co-ordination efforts at the domestic level to ensure that OIE standards are evenly implemented by the different competent authorities.
The OIE Secretariat makes significant efforts to support its Members in implementing OIE standards, namely with the variety of tools described in Chapter 3. The OIE’s World Assembly of Delegates, as the highest authority of the OIE bringing together all Member countries, is the main body in charge of overseeing from the highest political level the advocacy, assistance and monitoring of implementation of the standards. This is comparable to other IOs surveyed by the OECD in 2018, who in a majority of cases invest either a high-level body or a technical body of implementation-related tasks.24
Figure 1.6. Which is the designated competent authority in your country responsible for developing sanitary requirements applied to the importation of commodities?
145 respondents
Note: The percentages do not add up to 100%, because respondents often included various competent authorities.
Source: OIE questionnaire Technical Item 1, 86th General Session, World Assembly, World Organisation for Animal Health, May 2018.
Conclusion: Key features of the body of OIE normative instruments
The OIE develops and maintains a corpus of different voluntary normative instruments. This corpus of instruments is largely dominated by Codes and Manuals, which follow the most comprehensive expert‑driven procedure and are the most widely used by the Members among the OIE instruments. Logically, these Codes and Manuals are therefore also the normative instruments that are subject to monitoring of implementation. These monitoring mechanisms are the subject of Chapter 2.
Namely thanks to the expert-driven standard-setting procedure of the Codes and Manuals, these instruments remain highly technical, and serve as a support for OIE Members’ veterinary authorities in the development of veterinary legislation as well as in the diagnosis of diseases. As such, they benefit from dynamic involvement of OIE Members through the various technical bodies that allow for expert discussions on new areas of scientific developments and in support of an active use of the OIE acquis.
Within the OIE corpus, the Official Recognition of Disease Status is a unique procedure established by the OIE for certain diseases that provides a normative statement by the organisation and reflects the outcome of implementation of the OIE Terrestrial Code and Manual. It can therefore be used as a reference by OIE Members to demonstrate compliance with OIE standards and gain access to export markets. More broadly, the maintenance of the status by a Member gives confidence and demonstrates the capabilities that the Member is able to comply with the OIE standards.
The OIE benefits from a largely monopolistic position within the international standards sphere of animal health, as no other international body sets standards in the precise same area, despite some common areas of work with other organisations such as the WHO and the Codex Alimentarius. The WTO SPS Agreement’s recognition of the OIE’s standards as a reference for animal health standards gives additional visibility to the OIE normative instruments and reinforces the incentives for countries to consider them more systematically when setting domestic veterinary legislation. Overall, the OIE’s position as unique international standard-setting body in its field helps prevent duplication of international standards and simplifies domestic regulators’ search for relevant international instruments in their drafting of veterinary legislation. In fine, these features should make easier OIE’s task of tracking the use of their instruments in domestic regulatory measures.
In addition, the clear and well-defined mandate of the OIE combines with a rather homogenous set of bodies involved in the implementation of OIE standards at the domestic level. Indeed, a large majority of OIE Members have veterinary authorities involved in the development of national measures setting sanitary requirements for market access. This allows for a relatively homogeneous landscape across countries of OIE contact points and provides for an ideal source of information regarding the implementation of OIE normative instruments.
Still, while the adoption of OIE instruments in domestic legislation is encouraged by various normative documents, the practical approach to do so is not clearly defined or prescribed owing to their voluntary nature of these instruments. As a result, domestic measures may implement them only partially or differently to adapt to specific conditions.
References
[11] Bucher, K., D. Tellechea and G. Mylrea (2019), “Safe trade of aquatic animals and aquatic animal products: exploring the use of OIE international standards for setting sanitary measures”, OIE Scientific and Technical Review, Vol. 38/2.
[10] Combacau, J. and S. Sur (2016), Droit international public, LGDJ-Lextenso, https://www.lgdj.fr/droit-international-public-9782275045092.html (accessed on 12 September 2018).
[12] Kahn, B. (2018), Implementation of OIE Standards by OIE Member Countries: State of Play and Specific Capacity Building Needs. Descriptive Analysis of the Questionnaire.
[1] OECD (2019), The Contribution of International Organisations to a Rule-Based International System, OECD, Paris, http://www.oecd.org/gov/regulatory-policy/IO-Rule-Based%20System.pdf.
[2] OECD (2016), International Regulatory Co-operation: The Role of International Organisations in Fostering Better Rules of Globalisation, OECD Publishing, Paris, https://dx.doi.org/10.1787/9789264244047-en.
[3] OECD/WTO (2019), Facilitating Trade through Regulatory Cooperation: The Case of the WTO’s TBT/SPS Agreements and Committees, OECD Publishing, Paris/World Trade Organization, Geneva, https://dx.doi.org/10.1787/ad3c655f-en.
[8] OIE (2019), OIE Tool for the Evaluation of Performance of Veterinary Services, PVS Tool, Seventh Edition, http://www.oie.int/fileadmin/Home/eng/Support_to_OIE_Members/pdf/AF-PVSTool.pdf.
[6] OIE (2018), Guidelines for Investigation of Suspicious Biological Events (Guidelines for National Veterinary Services), http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/Guidelines_Investigation_Suspicious_Biological_Events.pdf.
[9] OIE (2018), OIE List of Antimicrobial Agents of Veterinary Importance, http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/AMR/A_OIE_List_antimicrobials_May2018.pdf.
[4] OIE (2016), Procedures used by the OIE to set standards and recommendations for international trade, with a focus on the Terrestrial and aquatic animal health codes, http://www.oie.int/fileadmin/Home/eng/Internationa_Standard_Setting/docs/pdf/A_OIE_procedures_standards_2016.pdf.
[5] OIE (2014), Guidelines for Animal Disease Control, http://www.oie.int/fileadmin/home/eng/our_scientific_expertise/docs/pdf/a_guidelines_for_animal_disease_control_final.pdf.
[7] OIE (2013), Veterinary Education Core Curriculum, OIE Guidelines, http://www.oie.int/Veterinary_Education_Core_Curriculum.pdf.
Notes
← 1. For further details on the objectives of the OIE, see www.oie.int/about-us/our-missions/.
← 3. Terrestrial Animal Health Code available at www.oie.int/en/standard-setting/terrestrial-code/access-online/.
Aquatic Animal Health Code available at www.oie.int/en/standard-setting/aquatic-code/access-online/.
← 4. Terrestrial Manual available at www.oie.int/en/standard-setting/terrestrial-manual/access-online/.
Aquatic Manual available at www.oie.int/en/standard-setting/aquatic-manual/access-online/.
← 5. General Rules of the World Organisation for Animal Health (Articles 1, 50, 59, 60).
← 6. See Introduction (How to Use This Terrestrial Manual) at www.oie.int/standard-setting/terrestrial-manual/access-online/; and foreword for Aquatic Manual, at www.oie.int/index.php?id=2439&L=0&htmfile=avant-propos.htm.
← 7. Terms of reference and internal rules of the regional commissions and regional conferences. See www.oie.int/fileadmin/home/eng/about_us/docs/pdf/basic_text/80%20sg19_basictexts_ang%20part%202.pdf.
← 8. The list of MoUs concluded by the OIE are here: www.oie.int/en/about-us/key-texts/cooperation-agreements/.
← 10. The terrestrial animal health standards commission; the scientific commission for animal diseases; the biological standards commission; and the aquatic animal health standards commission. www.oie.int/about-us/wo/commissions-master/.
← 11. www.oie.int/standard-setting/specialists-commissions-working-ad-hoc-groups/working-groups-reports/.
← 16. These work programmes are included in the meeting reports of each Specialist commission, available at www.oie.int/standard-setting/specialists-commissions-working-ad-hoc-groups/scientific-commission-reports/meetings-reports/.
← 17. www.oie.int/fileadmin/home/eng/about_us/docs/pdf/basic_text/80%20sg19_basictexts_ang%20part%202.pdf.
← 18. Art 5 of Appendix to International Agreement of the OIE, www.oie.int/about-us/key-texts/basic-texts/international-agreement-for-the-creation-of-an-office-international-des-epizooties/.
← 22. See articles 3 and 5 of the SPS Agreement.
← 23. www.oie.int/fileadmin/home/eng/health_standards/aahc/2010/en_glossaire.htm#terme_autorite_veterinaire. See a similar definition under the Glossary of the Aquatic Code at www.oie.int/index.php?id=171&L=0&htmfile=glossaire.htm.
← 24. OECD 2018 IO Survey.