2. Existing mechanisms supporting and monitoring the implementation of OIE standards

This chapter takes stock of the mechanisms that currently exist within the OIE or beyond that are used, or may be used, to gather information on the implementation of OIE standards in domestic jurisdictions. The current chapter finds 13 such mechanisms, most of which are set up by the OIE itself, and others that exist in the context of the World Trade Organisation or of the European Union for example. These mechanisms were initially set up to address specific needs, such as evaluating the quality and building domestic capacity of veterinary services, or monitoring the effects of domestic regulations on trade among others. Therefore the information they provide on the implementation of OIE standards is limited in scope and irregular in frequency. This chapter identifies the extent to which these existing mechanisms can be used to feed into the work of the OIE observatory and where further information is needed.

    

Various internal and external mechanisms already exist that look into country implementation practices of OIE standards, namely with three major objectives: to monitor countries’ animal health and welfare systems, to monitor OIE Member countries’ sanitary status, and to monitor the impact of veterinary measures on trade. In addition, a number of mechanisms monitor implementation on specific regional or thematic issues. While OIE monitoring mechanisms mainly pursue the first two objectives, impacts on international trade are mainly monitored through WTO mechanisms. The EU Commission has one mechanism monitoring among others the animal health legislation within EU Member countries.

Figure ‎2.1 synthetises mechanisms that collect information of relevance to OIE normative instruments. Most monitor areas related to the OIE Codes. Much less are related to the implementation of OIE Manuals. Overall, and from a very preliminary mapping, the existing OIE mechanisms cover around a quarter of the OIE Codes and Manuals.1 The Thematic items of the World Assembly of Delegates (WAD) do not have a pre-defined scope of standards they apply to and may cover all and any of the OIE acquis. The mechanisms of the WTO and the EU Commission do not specify the OIE normative instruments, but relate to the OIE Codes and Manuals in a broad sense.

Figure ‎2.1. Overview of potential “monitoring” mechanisms and their relevance to OIE standards

Notes: The full lines show monitoring of instruments as it is officially provided for in texts or terms of reference. The dotted lines provide indication of possible monitoring, despite no explicit mention of the normative instruments.

Source: Author’s own elaboration.

Overall, a wealth of information is gathered through these mechanisms, used extensively by countries to improve their own veterinary systems, evaluate the veterinary situation of their trading partners and to reinforce trust of trading partners in their own veterinary systems. These are not mechanisms monitoring or evaluating implementation per se (see Box ‎2.1). Indeed, the information is generally not collected with a view to assess the uptake of OIE standards in national legislation, but rather as a result of mechanisms set in different backgrounds, with different objectives, and conducted by different authorities (whether in the OIE or outside). Consequently, these mechanisms function mostly in silos, without much overlaps or coordination, and without an explicit role of feeding in to the standard-setting process. Nevertheless, they provide an invaluable resource for the OIE Observatory insofar as they gather significant information on implementation of OIE standards. They may still require readjustments to ensure that the information is adequate to serve the purpose of the Observatory.

Box ‎2.1. Defining monitoring & evaluation

Notwithstanding their complementarity, monitoring and evaluation are two different practices, with different dynamics and goals (OECD, 2019[1]). There is no internationally agreed definition of either term, but practice from the national policymaking context can be used to understand the concepts of monitoring and evaluation of international rules and standards.

Monitoring is used to designate a systematic collection, analysis and presentation of information/ data to gather indications of the extent of progress and achievement of objectives in relation to an agreed schedule.¹ Policy monitoring in particular refers to a continuous function that uses systematic data collection on specific indicators to provide policy makers and stakeholders with information regarding progress and achievements of an ongoing public policy initiative and/or the use of allocated funds (OECD, 2016[2]). Policy monitoring therefore contributes to planning and operational decision making, as it provides evidence to measure performance and can help to raise specific questions in order to identify implementation delays or bottlenecks. It can also strengthen accountability related to the use of resources, the efficiency of internal management processes, or the outputs of a given policy initiative (OECD, 2017[3]).

Evaluation of domestic laws and regulations can be done either ex ante, to identify likely costs and benefits of a regulatory or non regulatory option for a policy under consideration, or ex post, assessing the effectiveness of policies or regulations once they are in force (OECD, 2018[4]). The evaluation of the implementation of international standards can be assimilated to ex post evaluation of laws and regulations at the national level. Such evaluation consists in examining the relevance, effectiveness, and impacts of regulatory decisions, as well as, identifying unintended outcomes, reason for failure, and factors contributing to success (OECD, 2016[5]). Policy evaluation at the national level is found to serve two main purposes. It fosters learning by helping policy makers understand why and how a policy was successful or not. Consequently, it contributes to strategic decision-making, by providing insights on how to improve the links between policy decisions and outcomes. In addition, policy evaluation promotes accountability as it provides citizens and a broad range of stakeholders – such as journalists and academics - with information whether the efforts carried out by the government, including the financial resources mobilised for them, are producing the expected results (OECD, 2017[3]).

1 See definitions of monitoring for specific contexts in (OECD, 2010[6]), (OECD, 2018[4]) and (Eurostat, 2014[7]).

Source: (OECD, 2019[1]); (OECD, 2016[2]); (OECD, 2017[3]); (OECD, 2018[4]); (OECD, 2016[5]); (OECD, 2017[3]).

Mechanisms collecting information on countries’ animal health and welfare system: the PVS Pathway

Quality of veterinary services lay the institutional foundation for an effective implementation of OIE standards at the national level. The Veterinary Services are “the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and recommendations in the Terrestrial Code and the OIE Aquatic Animal Health Code in the territory (…).”2 The OIE therefore set up a complex system for evaluating the quality of veterinary services, by specific experts trained and certified by the OIE.

The OIE PVS Pathway is a general programme that aims to ensure that OIE Members’ veterinary services are capable of implementing OIE standards. It entails several steps to make an assessment of country’s veterinary systems (through a PVS Evaluation), make recommendations to improve them (through a PVS Gap Analysis) and to assist in the reinforcement of the veterinary services (through veterinary legislation support programmes, or other targeted capacity building activities).

Figure ‎2.2. OIE PVS Pathway

Source: (OIE, 2019[8]), “OIE Tool for the Evaluation of Performance of Veterinary Services”, 7th edition, http://www.oie.int/fileadmin/home/eng/support_to_oie_members/pdf/af-pvstool.pdf.

The normative framework, i.e. the OIE standards setting criteria for quality veterinary services, are found in the OIE Terrestrial and Aquatic Codes, and serve as a basis in the conduct of the valuations:

• Terrestrial Code: Section 33 is specifically dedicated to the quality of veterinary services. This Section covers fundamental principles applicable to veterinary services (Chapter 3.1), the principles and criteria for the evaluation of veterinary services (Chapter 3.2), communication by veterinary services (Chapter 3.3) and the procedure and institutional setting necessary for the development of veterinary legislation (Chapter 3.4). In addition, a number of articles throughout the Code include specific standards applicable to veterinary services.

• Aquatic Code: Section 34 is briefer than the Terrestrial Code, and is specifically dedicated to the quality of aquatic animal health services (Chapter 3.1) and communication by veterinary services (Chapter 3.2).

PVS Evaluations systematically assess the quality of Veterinary Services, including their implementation of the OIE standards by Veterinary Services. In addition, specific procedures exist to assess use of OIE standards in veterinary legislation, through the Veterinary legislation support programme. The subsequent stages in the PVS Pathway help address the challenges identified in the Evaluations, allowing OIE Members to improve their implementation of the standards. The PVS Evaluation Follow-up missions then serve as a stocktaking of the progress made since the initial evaluation.

PVS Evaluations

PVS Evaluations are conducted on a voluntary basis at the request of OIE Member Countries. They involve an OIE certified team of 2-4 experts undertaking a 1-4 week mission (depending on size and complexity of the country) and assessing all aspects of Veterinary Services capacity via documentation review, field interviews and observations. A peer-reviewed PVS report is presented for country comments and finalisation.

Table ‎2.1. State of play of PVS Evaluation missions
As of 4 September 2018
OIE Region	Requests received (number of countries)1	Missions implemented	Reports available for restricted distribution to Donors and Partners	Reports available on the OIE website
Africa	53	51	33	11
Americas	27	26	10	9
Asia/ Pacific	28	27	11	4
Europe	20	20	10	2
Middle East	13	11	5	1
Total	141	135	69	27
1 The Members having requested PVS Evaluation missions are the following:
Africa (53): Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Rep., Chad, Comoros, Rep. of the Congo, Dem. Rep. of the Congo, Côte d'Ivoire, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Morocco, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, Swaziland, Tanzania, Togo, Tunisia, Uganda, Zambia, Zimbabwe.
Americas (27): Argentina, Bahamas, Barbados, Belize, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Rep., Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Trinidad and Tobago, Uruguay, Venezuela.
Asia-Pacific (28): Australia, Bangladesh, Bhutan, Brunei, Cambodia, Chinese Taipei, Fiji, India, Indonesia, Iran, Japan, Dem. People's Rep. of Korea, Laos, Maldives, Malaysia, Mongolia, Myanmar, Nepal, New Caledonia, Pakistan, Papua New Guinea, Philippines, Sri Lanka, Thailand, Timor Leste, Vanuatu, Vietnam.
Europe (20): Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Bulgaria, Former Yugolsav Republic of Macedonia, Georgia, Iceland, Israel, Kazakhstan, Kyrgyzstan, Montenegro, Romania, Serbia, Tajikistan, Turkey, Turkmenistan, Ukraine, Uzbekistan.
Middle-East (13): Afghanistan, Bahrein, Iraq, Jordan, Kuwait, Lebanon, Oman, Palestinian National Authority (observer), Qatar, Saudi Arabia, Syria, United Arab Emirates, Yemen.
Source: http://www.oie.int/solidarity/pvs-evaluations/status-of-missions/.

So far they have mostly occurred in developing countries.5 However, developed countries are increasingly requesting PVS Evaluations. Recent cases have included Australia, Japan and Canada. Iceland and Mexico.6 To date, 135 evaluation missions have been conducted, 50 of which have been the subject of PVS Evaluation follow-up missions.

PVS Evaluations involve some costs for the evaluated Members, who cover the venues and transport of the mission teams in their country and need dedicated staff to co-ordinate the PVS Evaluation. PVS Pathway expert costs are generally covered by the OIE, via their donor funded Animal Health and Welfare Fund, except for developed or other countries ineligible for donor support. Some regions benefit more frequently from PVS missions than others, depending on Member country and donor interest.

PVS Evaluations are conducted following the OIE Tool for the Evaluation of Performance of Veterinary Services (the “OIE PVS Tool) updated in 2019 (OIE, 2019[8]), and the OIE PVS Tool: Aquatic. These two tools describe the methodology for conducting evaluations of Veterinary Services in line with the standards included in the OIE Terrestrial and Aquatic Codes (cf. spec. Chapter 3.2 Terrestrial Code on evaluation). An update of the PVS Tool has been finalised in 2018, and published in 2019 as the seventh edition of the PVS Tool. A process to update Chapters 3.1 and 3.2 of the Terrestrial Code has also been initiated.

The evaluations are conducted against four Fundamental Components, broken down into “Critical Competencies”, defined in-depth in the PVS Tool, with references to the specific OIE standards applicable. For each Critical Competency, a list of indicators is used by the assessors to determine countries’ qualitative “level of advancement”, i.e. the level of compliance with the OIE standards. In general, the levels of advancement range from 1 (no or limited capacity/capability) to 5 (high capacity and capability, fully compliant with international standards). The criteria for evaluating the level of advancement for each critical competency is defined in the PVS Tool. Each PVS Evaluation report includes a table summarising the evaluation results for all critical competencies.7

PVS Evaluation follow-up missions use the same methodology as the initial PVS Evaluation missions. They use as a baseline the level of advancement at the time of the initial PVS Evaluation mission, and the expected level of advancement identified in the PVS Gap Analysis. Like in the PVS Evaluation, an overall Summary of OIE PVS evaluation results is available.8

Six critical competencies in particular provide an overview of the status of implementation of OIE standards specific to veterinary legislation and regulations and access to markets. The principles of each of these six critical competencies are described in Box ‎2.2.

Box ‎2.2. Critical competencies related to veterinary legislation and market access

IV-1 Veterinary legislation

A. Legal quality and coverage

The authority and capability of the VS to develop or update veterinary legislation to ensure its quality and coverage of the veterinary domain.

This competency covers the quality of legislation considering the principles of legal drafting, its impact, and suitability for implementation.

This competency includes formal collaboration with other legal drafting professionals, other relevant ministries and Competent Authorities, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas of the veterinary domain. It also covers stakeholder consultation relevant to veterinary legislation.

B. Implementation and compliance

The authority and capability of the VS to ensure compliance with legislation and regulations across the veterinary domain through communications and compliance inspection activities.

This competency includes formal collaboration with other relevant ministries and Competent Authorities, national agencies and decentralised institutions that share responsibility for implementation, or have mutual interest in relevant areas.

IV-3 International harmonisation

The authority and capability of the VS to be active in the harmonisation of national regulations and sanitary measures to ensure they take into account international standards, and/or related regional directives or guidelines.

IV-4 International certification

The authority and capability of the VS to reliably certify animals and animal products, and related services and processes under their mandate, for export, in accordance with national legislation and regulations, international standards and importing country requirements.

This refers to the country’s veterinary export certification processes. Issues such as: the legislative basis, format and content of veterinary certificates; who signs certificates and the confidence they have in what they are certifying; and the outcome in terms of meeting international standards and/or importing country requirements to facilitate exportation should all be considered.

IV-5 Equivalence and other types of sanitary requirements

The authority and capability of the VS to apply flexibility in negotiating, implementing and maintaining equivalence and other types of sanitary agreements with trading partners.

IV-6 Transparency

The authority and capability of the VS to notify the OIE, WTO, trading partners and other relevant organisations of its disease status, regulations and sanitary measures and systems, in accordance with established procedures, as applicable to international trade.

Source: (OIE, 2013[9]), “OIE Tool for the Evaluation of Performance of Veterinary Services”, 6th Edition, www.oie.int/fileadmin/Home/eng/Support_to_OIE_Members/pdf/PVS_A_Tool_Final_Edition_2013.pdf.

Overall, the PVS Evaluations are an important source of country-level information, focused on the systems or “horizontal” chapters of the OIE Codes. The PVS Evaluations provide an in-depth understanding of existing veterinary system in OIE Members. They provide less information at the detailed disease level of the “vertical” chapters. The PVS methodology details levels of advancement of assessed Members, providing an indication of the consistency between national legislation and OIE standards. When complemented by follow-up missions, the evaluations provide information on the evolution of implementation of the standards over time. However, this information is incomplete for the purposes of the OIE observatory, in terms of geographic scope, time coverage, and assessment of the use of the standards.

The geographic scope of the evaluations is limited to the countries requesting a PVS Evaluation. In particular, PVS Evaluations do not cover any of the EU countries for which EU regulatory processes exist. As a result, there is no overall assessment of all OIE Member Countries, making it difficult to draw broad assessments on trends of implementation by OIE Members as a whole. The evaluation is not systematic nor regular, as it depends on countries’ requests. The information about implementation of OIE standards is therefore limited to a single period in time, which may be updated with information in a follow-up mission. Although the evaluations take as a baseline OIE standards, to assess situations in individual countries, the evaluation mostly relies on field missions, interviews and general research about the country, rather than assessment of disease-specific national measures in comparison with OIE standards.

In addition, the use of this information for monitoring purpose raises a number of challenges. The OIE Secretariat does not keep a centralised source of information to identify trends among OIE Members. The reports are kept in PDF formats, which make comparisons difficult to conduct. In order to address this issue, the OIE is currently designing a database of PVS evaluation reports that will facilitate the search of evidence and data from these reports.

The PVS Evaluation and follow-up mission reports are only made available to the public upon authorisation of the evaluated country. Evaluated countries may choose to make the report available to the general public on the OIE website, to keep distribution limited to donors and partners, or to restrict the publicity of the reports completely. In practice, availability to the public is still quite ad hoc (30 out of 135 PVS Evaluation reports are available on the OIE website). In more than half the cases, the evaluated country choses to make the report available only to donors and partners (69 reports out of 135 PVS missions). There is an on-going initiative to facilitate accessibility to existing PVS Pathway mission reports. However, the secretariat, including after consultation with its Members, feels that the possibility of keeping the PVS reports confidential is an important component of the trust established between the organisation and its Members. This does not prevent the use of information for analytical purposes and in aggregate form.

Veterinary Legislation Support Programme (VLSP)

The VLSP is a component of the PVS Pathway. It consists of two components, the veterinary legislation identification missions (VLIM) and the veterinary legislation Agreement. The VLIMs are an opportunity to train regulators to more systematically consider international standards, and in particular OIE standards, in their regulatory process. In this process, the OIE Secretariat can gain more in-depth understanding on the veterinary legislation in OIE Members, and can thus gather additional evidence on the use of OIE standards to complement the information gathered during PVS Evaluation missions.

VLIM are launched at the request of OIE Members, as a follow-up to PVS Evaluations. This means that countries having undergone a VLIM are a subset of countries that have benefited from an initial PVS Evaluation mission. A total of 62 VLIM missions have been conducted to date, only in developing countries.9 For only six of these are the reports publically available (Burundi, Chad, Ghana, Kenya, Mozambique, Rwanda).

The VLIM is an opportunity to undertake a detailed assessment of veterinary legislation in the country. In these missions, certified OIE VLSP experts assess the country’s veterinary legislation against the standards for veterinary legislation as listed in Chapter 3.4 of the Terrestrial Code. This includes general principles (such as the respect for the hierarchy of legislation, legal basis, transparency, consultation, and the quality of legislation and legal certainty), as well as specific provisions on the drafting of the articles.

The methodology to follow for the VLSP is explained in three Manuals for experts:

• The first manual lays down general considerations on legal drafting, as provided in Chapter 3.4 of the Terrestrial Code. The manual goes point by point on the issues to be considered when assessing a country’s legislation in order to ensure compliance with the relevant standards of the Terrestrial Code.

• The second manual sets the procedure of the mission: the team identifies in advance of the mission who they might need to speak to and other necessary information, for instance by consulting the database Faolex10 for existing legislation in the country. The experts send out questionnaires on the legislative domain, with specific questions on the existence of legislation in the different areas of the Codes.

• The third manual provides working examples of veterinary legislation, to illustrate the key elements that may be included in a law, with a preamble, definitions, etc.

The VLIM missions are usually a week long, and composed of two experts, a veterinarian and a lawyer, who submit their report within a month after the mission. The report is sent back to the country delegates who can comment and ask for changes. If there is willingness and sufficient infrastructure to further improve the veterinary legislation, the OIE may conclude with the Member country a Veterinary Legislation Agreement, in which the OIE supports the country in amending existing legislation or drafting new legislation to address the recommendations set in the identification mission.11

In the same line as the PVS Evaluations, however, the evidence gathered during Veterinary Legislation Identification mission remains for the specific use of the evaluated OIE Member, suffering similar limitations. The scope of information remains limited to mostly developing countries, and the evaluations are not regular, therefore failing to provide a continuous state of play. Questionnaires examine compliance with certain horizontal chapters of the Codes (those listed in Chapter 3.4), asking countries to provide information on the relevant legislation in force. The use of disease-specific OIE standards is not assessed in specific national legislation. Like for PVS Evaluations, the final report is made public only if the evaluated country allows it. In some cases, the evaluated country choses to make their report available only to donors and partners.

Mechanisms to collect information on the sanitary status of OIE listed diseases for country, zone or compartment

One of the key objectives of the OIE is to ensure continuous transparency of disease outbreaks and all kinds of epidemiological events in their Member countries. To do so, the OIE has set up several tools through which OIE Members can be informed of the disease status in other countries.

The World Animal Health Information System (WAHIS) and the Self-Declarations provide mechanisms for reporting the status of diseases in OIE Members, based on countries self assessment and declaration. For six diseases, the OIE acts as an independent third party, and offers an official disease status recognition to OIE Members. This information is extensively used to facilitate trade between OIE Members. WAHIS and the OIE official disease status entail regular updates. The self-declarations are published by date, and are listed as “active”, “temporary” or “not active.

In addition, to support countries in diagnosing diseases and gathering information at the local level, the OIE has set up Reference Laboratories, with designated experts that serve as a reference to all authorities within a country or region needing support in the diagnosis and control of diseases. While they do not have a mandate to monitor implementation of OIE standards per se, they gather relevant information when conducting testing or diagnoses for diseases; they have an obligation to inform the OIE WAHIS team of disease outbreaks; and their annual reports cover trends in implementation of OIE standards.

World Animal Health Information System (WAHIS)

The necessary information is gathered through mandatory notifications by OIE Members of first occurrence, recurrence or a sudden change related to a listed disease, infection or infestation, as well as an emerging disease, in a country, a zone or a compartment, as requested by articles 1.1.3-1.1.4 of both the Terrestrial and Aquatic Codes (Box ‎2.3). The notifications entail information about the first occurrence, recurrence or sudden changes related to OIE-listed diseases, as defined in disease-specific chapters of both Codes, as well as about the type of disease preventive and control measures. The national legislations themselves are not shared through the WAHIS notifications; it is a procedure of reporting via codified templates.

In other words, the WAHIS notifications allow to gather information on the implementation of articles 1.1.3-1.1.4 (notification obligation), on the diseases as defined by the Codes (Volume II of the Terrestrial Code; Sections 8, 9, 10, 11 of Aquatic Code) and on preventive and control measures.

Notifications by OIE Members are submitted in different timeframes depending on the type of measures:

• Notifications in real time (under 24 hours): occurrence, recurrence or sudden change in listed diseases;

• Weekly reports: “to provide further information on the evolution of the event which justified the notification. These reports should continue until the disease, infection or infestation has been eradicated or the situation has become sufficiently stable”;

• Notifications every six months: “on the absence or presence and evolution of listed diseases”.

In addition, the World Animal Health Information and Analysis Department (WAHIAD) also actively tracks “rumours” regarding disease outbreaks. If outbreaks occur and have not been notified to WAHIS, the Secretariat contacts the delegate of the country concerned to encourage notification. The Secretariat does not, however, have the authority to invalidate a notification or submit information to the public itself. The notified information is available to the general public on the WAHIS interface webpage.12 Interested parties may choose to get WAHIS alerts directly on mobile phone devices.13

Box ‎2.3. WAHIS notification provisions, Terrestrial Code

Article 1.1.3.

Veterinary Authorities shall, under the responsibility of the Delegate, send to the Headquarters:

1. 1. In accordance with relevant provisions in the disease-specific chapters, notification, through the World Animal Health Information System (WAHIS) or by fax or email within 24 hours, of any of the following events:

   1. a) first occurrence of a listed disease, infection or infestation in a country, a zone or a compartment;

   2. b) recurrence of a listed disease, infection or infestation in a country, a zone or a compartment following the final report that declared the outbreak ended;

   3. c) first occurrence of a new strain of a pathogenic agent of a listed disease, infection or infestation in a country, a zone or a compartment;

   4. d) a sudden and unexpected change in the distribution or increase in incidence or virulence of, or morbidity or mortality caused by, the pathogenic agent of a listed disease, infection or infestation present within a country, a zone or a compartment;

   5. e) occurrence of a listed disease, infection or infestation in an unusual host species.

2. 2. Weekly reports subsequent to a notification under point 1) above, to provide further information on the evolution of the event which justified the notification. These reports should continue until the disease, infection or infestation has been eradicated or the situation has become sufficiently stable so that six-monthly reporting under point 3) will satisfy the obligation of the Member country; for each event notified, a final report should be submitted;

3. 3. Six-monthly reports on the absence or presence and evolution of listed diseases, infections or infestations and information of epidemiological significance to other Member countries;

4. 4. Annual reports concerning any other information of significance to other Member countries.

Article 1.1.4.

Veterinary Authorities shall, under the responsibility of the Delegate, send to the Headquarters:

1. 5. A notification through WAHIS or by fax or email, when an emerging disease has been detected in a country, a zone or a compartment;

2. 6. Periodic reports subsequent to a notification of an emerging disease:

   1. a) for the time necessary to have reasonable certainty that:

      1. i. the disease, infection or infestation has been eradicated; or

      2. ii. the situation has become stable;

OR

1. b) until sufficient scientific information is available to determine whether it meets the criteria for inclusion in the OIE list as described in Chapter 1.2

2. c) A final report once point 2 a) or b) above is complied with.

Source: OIE Terrestrial Code, www.oie.int/index.php?id=169&L=0&htmfile=chapitre_notification.htm.

The WAHIS notification system is unique in providing continuous information on factual situations regarding OIE listed diseases throughout OIE Member countries, outbreaks and changes to disease situations. Thanks to its relation to specific diseases listed in OIE Codes and related control measures, the WAHIS procedure has great potential to support the monitoring of implementation of notification obligations.

Nevertheless, the notification process would need to be adapted to allow for tracking implementation of OIE standards. In particular, the WAHIS notification procedures make few direct references to the Terrestrial or Aquatic Codes for each of the disease prevention and control measures.14 This prevents from clearly monitoring the implementation of specific standards, and from making an automatic referencing of implementation. In addition, there is no detail on the control and prevention measures. The notification procedure only asks to tick boxes on the types of measures adopted and does not allow to identify the national legislation in which OIE standards are being implemented.

Self-declaration of disease status

Beyond the regular reporting through the WAHIS database, countries may choose to make a more in-depth self-declaration of their disease status for both aquatic and terrestrial diseases, according to art. 1.6 of the Terrestrial Code and 1.4. of the Aquatic Code. Contrary to official recognition of disease statuses, described below, these self-declarations are reviewed but not scrutinised in the same depths by the OIE Secretariat or Members before being published. They may be submitted by any OIE Member. By early 2019, there were 176 self-declarations available on the OIE website from 60 countries (30 OECD countries and 30 non-OECD ones).15

The self-declarations must include a list of information, including evidence on compliance with the disease-specific standards of the Terrestrial and Aquatic Codes (OIE, 2019, p. 5 et seq[10]). The standard operating procedures for self-declarations are not included in the Codes and can therefore be modified more flexibly.

The Disease Status Department (DSD) reviews the self-declaration and may choose to request further information, clarification, or update from WAHID, and may edit it as relevant. After the DSD and the delegate agree on the text, the Deputy Director General reviews the self-declaration, and decides if the self-declaration is acceptable for publication. If not, it informs the Member that it will not be published, if yes, the self-declaration is published on the OIE website (OIE, 2019[10]).16 Publication does not imply endorsement of the claim (art. 1.6.1 Terrestrial Code), which is highlighted by a disclaimer on the website. It is therefore very rare that the OIE does not publish a self-declaration. If it has doubts about the veracity of a self-declaration, the OIE secretariat may suggest that the OIE Member change the nature of its self-declaration to reflect more accurately the situation in accordance with the provisions of the Codes or Manuals.

Like for official disease status, self-declarations may provide useful evidence on efforts made by OIE Members to implement OIE standards on specific diseases. In addition, the scope of self-declarations is much wider than the OIE official recognitions, as self-declarations can potentially be made for any disease with the exclusion of those diseases part of the OIE procedure for official recognition of disease status. The DSD ensures a cross-checking with WAHIS notifications to ensure consistency of information provided in self-declarations, therefore building credibility of the mechanism.

However, in practice, the assessment made by the DSD is not in-depth, and does not guarantee the scientific validity of the declaration. The responsibility of the information contained in the self-declaration lies entirely with the Delegate of the Member concerned, without guarantees from the OIE. This limits the use of these self-declarations for monitoring implementation of OIE standards.

Official Recognition of Disease Status

The OIE delivers official recognition of disease status for six diseases:

• Foot and mouth disease (FMD);

• African horse sickness (AHS);

• Classical swine fever (CSF);

• Contagious bovine pleuropneumonia (CBPP);

• Peste des petits ruminants (PPR) and

• Bovine spongiform encephalopathy (BSE) risk status.

The procedure is voluntary and is launched at the request of an OIE Member for a specific zone or an entire country, particularly when they are interested in gaining trust of export markets. OIE Members are charged a fee between 5 000 and 9 000 EUR depending on the reviewed disease. Least Developed Countries are charged a lower fee, between 2 500 and 4 500 EUR. This procedure also offers the OIE endorsement of national official control programmes for FMD, CBPP and PPR to OIE Members that may not yet have reached the level to apply for a disease-free status, but wish to apply and demonstrate its compliance with the Terrestrial Code provisions.

The list of OIE Members that have an official disease-free or BSE risk status is published by disease on the OIE website.17 However, the information on the applications submitted by Members for the proposed disease status is not disclosed. For all applications submitted by Members, a detailed report is drafted on the evaluation performed by the relevant expert ad hoc Group and Specialist Commission. The assessment report on OIE Members that do not comply with OIE standards, to whom the status was not granted is kept confidential.

The majority of countries that have been recognised as free from the different diseases tend to be developed or emerging economies. For the countries who do not have the status, the information publically available is not sufficient to confirm whether this is because they have not undergone the procedure to obtain the official recognition (i.e. all countries may not have an interest in applying for disease recognition for all diseases depending on their animal exports), or because they have not received a positive assessment.

The standards that serve as a basis for the assessment of an official disease status are in the Terrestrial Code and Manual. Countries wishing to obtain the official disease status must present to the OIE Secretariat documentation demonstrating:18

• compliance of their veterinary services with Chapters 1.1, 3.1 and 3.2 of the Terrestrial Code;

• compliance with the specific criteria relating to the disease at stake. The Terrestrial Code includes in Chapters 1.7 – 1.12 the questionnaire countries must complete and provide documented evidence demonstrating its compliance with the provisions of the Code to achieve the disease free status for these six diseases. These chapters make reference to provisions of the relevant disease chapters in the Terrestrial Code and the Terrestrial Manual.

The information on compliance with relevant standards of the OIE Terrestrial Code must be substantiated in a detailed application, following the questionnaires and standard operating procedures for the official recognition of disease status.

The same procedure applies for the OIE endorsement of official control programmes, for countries who want to work towards achieving a disease-free status, but may not yet have the appropriate measures or infrastructure in place to ensure disease-free status.

The official recognition of disease status offers a rigorous procedure to assess implementation of specific OIE Standards (Box ‎2.4). The regular updates through the yearly reconfirmation procedure allow to have a continuous overview of the disease status in OIE Member countries. In addition, the examination of disease statuses by the OIE Secretariat provide an opportunity to ensure cross-checking of consistency between findings of PVS Evaluations and the official recognition of disease status.

Box ‎2.4. OIE Procedure for Official Recognition of Disease Status

The Official recognition of disease status follows a detailed procedure involving close co ordination between the OIE Secretariat, discussions by experts within an ad hoc group and examination by a Specialist Commission, the Scientific Commission for Animal Diseases (SCAD), and finally a political endorsement both by high-level management of the OIE and by the World Assembly of Delegates.

The Disease Status Department (DSD) of the OIE Secretariat is responsible for processing the applications of OIE Members for official status. This involves checking administrative and technical compliance with the Terrestrial Code and the rules of procedure, making sure that the OIE Member has responded to all the questions in a coherent manner.

The DSD prepares the relevant information regarding the OIE Members’ application in view of its discussion in an ad hoc group, composed of experts, selected with regional representativeness and different areas of disease expertise. The ad hoc group reviews applications and may make additional questions in line with the Terrestrial Code requirements to the applying Member. The ad hoc group drafts a report on its assessment and formulating recommendations for SCAD, with a possible recommendation of an in country mission. Negative assessment are based on insufficient evidence provided by the assessed Member to demonstrate that the country or zone is disease-free in accordance with the Terrestrial Code provisions.

The application dossier and the report of the ad hoc group is then sent for examination by SCAD, who decides on the outcome of the assessment of each application. The report of SCAD meetings are made public, which includes the detailed assessment report only of countries having received a positive assessment from SCAD. Upon announcement to all OIE Delegates via an official letter informing of the OIE Members and zones for official recognition to be proposed at the General Session for adoption, other OIE Members have 60 days to ask questions about or comment on the application. In practice, some questions are posed by other Members, and the Secretariat redirects them to the assessed country. Oppositions to the proposed list of Members and zones for adoption by other Members during these 60 days happen very seldom.

The final report is endorsed by the Deputy Director General for International Standards and Science and by the Director General. Ultimately, the Official Recognition of Disease Status is recognised by the OIE World Assembly of Delegates, and adopted by a technical resolution (OIE, 2018[11]).

After the Official Status has been granted, Members must submit an application for reconfirmation by the 30th November of each year. This is to make sure that the statuses are reconfirmed annually by the OIE secretariat, to ensure that the status is up to date. The resolutions listing the OIE Members and zones having an official status or an endorsed control programme for each disease are adopted each year during the General Session.

Source: (OIE, 2019[10]), Standard Operating Procedure for official recognition of disease status and for the endorsement of national official control programmes of Member Countries, http://www.oie.int/fileadmin/home/eng/animal_health_in_the_world/docs/pdf/sop/en_sop_application.pdf.

However, to date, the process of official recognition pertains only to six diseases, which were progressively added and adopted by OIE Members to be part of this established procedure. The recourses needed to process applications for each disease are an important impediment to adding further diseases to the list.

In addition, the information on the disease free status is available publically, but mostly for the use of OIE Members in their trading relations. The OIE Secretariat does not seem to make use of official disease status for monitoring purposes. In particular, while the Secretariat has the knowledge about official disease status procedures and underlying evidence (leading to either positive or negative decision), it does not make use of this information for a general assessment on implementation of OIE standards related to these six diseases. This is in part due to a lack of resources, and in part to the will to preserve anonymity of countries who were not granted disease status.

OIE reference laboratories

The OIE provides a list of “referenced laboratories” within the Terrestrial and Aquatic Manuals, which serve as reference points for the OIE and its Member Countries on all diagnostic tests and vaccines. The endorsement process of referenced laboratories foresees the approval of the related expert with the objective to provide support to OIE Member Countries in diagnosing and controlling one specific disease (OIE, 2017[12]). These experts provide scientific and technical assistance and expert advice on all points related to the disease they are responsible for. Only one OIE Reference Laboratory per OIE Member Country for a given disease can be designated, but developed or emerging economies tend to have reference laboratories for various different diseases. France, Italy, the United Kingdom or the United States for example have more than 20 reference laboratories, and Australia, Canada, China and Germany have between 10-20 reference laboratories. A number of OIE Member countries are still lacking reference laboratories, namely in developing and least developed countries.19

To gain status, laboratories submit an application to the OIE following specific guidelines. The application is reviewed by the relevant Specialist Commission of the OIE (Biological Standards Commission or Aquatic Animal Health Standards Commission). The OIE Commissions assess the capacity, expertise and international reach of laboratories. In particular, they examine criteria such as the accreditation to the ISO 17025 or equivalent quality management system, the CV of the applying expert, national and international experience in diagnostic techniques, as well as capability for international shipment and receipt of samples, among others.20 The decision of the Specialist Commission is then submitted to the OIE Council for endorsement and to the WAD for a final decision by the adoption of a technical resolution.

Reference laboratories do not as such have a mandate to monitor implementation of OIE standards. However, in the process of conducting testing or diagnoses for diseases, they obtain information about OIE Members’ compliance or not with OIE standards in a specific zone or country. This information remains confidential, and may at best be communicated to the delegate of the country concerned. However, reference laboratories have an obligation to inform the OIE WAHIS team on their findings if disease outbreaks are not reported through the WAHIS system.21 When this is the case, the OIE contacts the Member delegate to encourage an updated WAHIS notification.

Annual reports of reference laboratories do provide some information on trends in implementation of OIE standards. These reports are based on reference laboratory terms of reference, and ask a number of questions related to the use of diagnostic methods based on OIE standards by each reference laboratory. When relevant, reference laboratories provide number of tests performed in relation to OIE standards, as well as other broad information concerning the implementation of OIE Manuals.22 While the information remains broad and in aggregates, it provides some information on the use of OIE Manuals in different regions.

In principle, a conference is held every four years between reference laboratories to promote communication and exchanges between different countries and regions. However, this conference has not been organised since 2014 due to lack of funding.

External WTO mechanisms to collect information on trade impacts of veterinary measures

The WTO has various transparency mechanisms that help provide evidence on the uptake of OIE standards. These mechanisms aim primarily to enhance the predictability and stability of measures applied by WTO Members (OECD/WTO, 2019[13]). Information shared by WTO Members through these mechanisms is centralised by the WTO Secretariat and thus made available to all WTO Members as well as to the public in general. As such, they represent an important source of information on domestic measures, including veterinary measures, with an impact on trade. Due to the encouragement for WTO Member countries to consider international standards, and in particular OIE standards, the WTO transparency mechanisms allow for some partial monitoring of the use of OIE standards in domestic veterinary measures.

WTO SPS notifications

The WTO SPS Agreement requires Members to notify domestic draft regulations when they have a significant impact on trade, when they are not based on an international standard, or that the content of the draft measure is not substantially the same as the relevant international standard (Article 7 and Annex B SPS Agreement). However, as noted above, the SPS Committee encourages notification of national measures based on international standards as well, as long as they have a significant impact on trade.

Overall, this process is an opportunity to gather evidence on the use of international standards in domestic legislation (WTO, 2009[14]) (WTO, 2008[15]). Indeed, the notification form filled in by WTO Members submitting a notification to the WTO Secretariat asks the Member to indicate the existence or not of an international standard, guideline or recommendation, whether or not the measure conforms with the international standard and if not, how and why the measure deviates from the international standard (see Annex C). The notifications submitted to the WTO contain descriptions of the measures adopted domestically, and often references to the actual texts. This information source is detailed and verifiable.

By 2018, a total of 18 277 SPS notifications had been submitted, covering areas of animal health, plant health, plant protection, food safety, etc. 23% of these notified measures indicate expressly a conformity with international standards, i.e. 4 133 SPS notifications. Out of these, 1 311 indicate conformity with OIE standards.23 Finally, 62 SPS notifications indicate that an SPS measure is covered by an OIE standard, but the measure does not conform with it. In other words, the number of SPS notifications confirming the conformity of national measures with OIE standards is marginal when considering the broad range of domestic SPS measures. However, it is important to note that the total notifications go well beyond the area of animal health. In absolute terms, the measures conforming with OIE standards represent substantive evidence into national measures adopting an OIE standard.

However, the information obtained through SPS notifications is likely partial. In particular, WTO Members do not have the legal obligation to notify measures that comply with international standards, even though they are encouraged to do so by the SPS Committee. The obligation to notify concerns specifically measures that are not based on international standards and have a significant impact on trade. In addition, the notification form does not require WTO Members to specify the exact standard used as a basis, beyond the standard-setting body that has adopted it. This makes it difficult to track implementation of individual standards. The notifying Member can also remain broad regarding the information it discloses about the level of conformity with the international standard. WTO Members are asked to tick a box to say if yes or no their measure conforms with an international standard. This does not leave space for specifying the extent to which the national measure reproduces the international standard, or takes elements of it.

On the other hand, the notification authorities are not necessarily well trained to identify relevant international standards. Indeed, in a survey to SPS Committee Members in 2015, the major challenge to notifications identified by respondents was the difficulty to identify whether the SPS measure conformed with an international standard (WTO, 2015[16]). This may be changing however since 2015, as several OIE delegates mention coordinating on a regular basis with their country’s WTO notification authority regarding domestic legislations to be notified, as well as on the interpretation of notifications by other Members.24

Using the WTO notifications database requires active efforts by the OIE secretariat to examine the content of the notified measures and identify its relation to OIE standards. In the first effort by OIE secretariat to make use of SPS notifications for monitoring aquatic animal health standards, (Bucher, Tellechea and Mylrea, 2019[17]) find that 77% of notifications report conforming with OIE standards. This evidence provides a useful reference to estimate compliance with OIE standards in the specific area of aquatic standards, and confirms the value of SPS notifications to monitor implementation of OIE standards. However, the authors themselves point to several limitations, including the limited number of relevant notifications (148 notifications over a period of close to 10 years), and the need to assess the notifications against the OIE standards individually, because information is not detailed by the notifying authority (Bucher, Tellechea and Mylrea, 2019, p. 7[17]).

Specific Trade Concerns raised in SPS Committee

Information publically available on WTO SPS Committee discussions represent an important source of information on the lack of implementation of international standards in general, and OIE standards in particular, as well as of the challenges and costs resulting for trading partners.

WTO Members use the SPS Committee of the WTO as a forum to discuss concerns they have with each other’s measures (OECD/WTO, 2019[13]). In particular, through the procedure of Specific Trade Concerns (STCs), they highlight possible or potential inconsistencies of national measures of other Members with obligations of the SPS Agreement and the challenges or unnecessary burdens they face as a result. All STCs are documented by the WTO Secretariat on a public database, and can be freely accessed and searched.25

As mentioned above, the SPS Agreement includes an obligation to base SPS measures on international standards except if scientific justification or risk assessment justify a higher level of protection (art. 3.1, 3.3 SPS Agreement), and cite OIE standards as a reference for international standards on animal health (Annex A 3 (b) SPS Agreement). Therefore, the STCs, which raise possible inconsistencies with the SPS Agreement, also allow to draw attention to potential inconsistencies with OIE standards. Overall, since 1995 and by mid-2018, 128 of the 447 SPS STCs raised included a mention of the OIE in the concern (i.e. 29%). While this remains a broad aggregate, it confirms some use of this mechanism to discuss OIE-related matters in the WTO SPS Committee.

The OIE uses this data source occasionally to gather evidence on implementation of OIE standards. Most recently, the OIE Secretariat has been conducting research on trends in STCs related to avian influenza, looking into the countries that most frequently raise concern, the countries whose measures are most frequently questioned, and the types of issues that are most discussed in relation to OIE standards on avian influenza. While the research is still on going, initial findings confirm a cross-fertilization between the OIE standard-setting process and the STCs raised in the WTO (Bucher, 2017[18]).

Monitoring of the process of international harmonisation by WTO Secretariat

The SPS Agreement envisages the monitoring by the SPS Committee of international harmonization and the use of international standards, guidelines and recommendations (art. 3.5; 12.4 SPS Agreement). This procedure aims to encourage the use of international, standards and recommendations, to identify where the non-use of such standards creates a major impact on trade, and to help the relevant IOs setting the standards identify where a standard was needed or was not appropriate for its purpose or use (WTO, 2004[19]).

In virtue of this procedure, the SPS Committee monitors the process of international harmonisation at each of its regular meetings. In practice, Members use this opportunity to raise issues to the attention of the SPS Committee Members related to other Members’ practice that may create barriers to trade because of a lack of consistency with international standards. These issues are then discussed in the Committee meetings and reflected in the minutes. Each year, the WTO Secretariat prepares an annual report, in which it gives an overview of the issues raised over the year (WTO, 2018[20]). Concretely, this serves as an opportunity for WTO Members to encourage compliance of other Members with international standards, including OIE standards. Box ‎2.5 provides examples of the OIE-related issues discussed in recent annual reports.

Box ‎2.5. Discussions on OIE standards in WTO SPS Committee meetings

Overview of issues in WTO SPS Committee Annual reports on the procedure to monitor the process of international harmonization:

• OIE chapter on porcine reproductive and respiratory syndrome (PRRS): noting concern that some countries were still implementing import restrictions that were not in line with OIE standards on PRRS, the United States, Canada and the European Union recalled the new OIE standard and encouraged all countries to apply the new OIE standard in this regard.¹

• BSE Restrictions not consistent with the OIE international standard: the United States regretted numerous unjustified restrictions it faced in its exports of live bovines, bovine meat and other products, inconsistent with OIE international standards. It reiterated its commitment to aligning its import regulations governing BSE OIE Guidelines and listed the US rules that were in line with the OIE standard.²

• Measures on bovine semen and reproductive material more restrictive than the OIE standard: Argentina observed that Members were applying measures which were not in accordance with several articles of the OIE Terrestrial Code, such as Articles 8.8.15, 8.8.17 and 8.8.19.³

¹ June 2018 annual report, para 2.14-2.16.

² May 2016 annual report, para 3.13-3.14.

³ May 2016 annual report, para. 3.18.

Source: (WTO, 2018[21]) (WTO, 2016[22]).

Trade Policy Review Mechanism26

WTO makes a regular monitoring of national trade policies through its Trade Policy Review Mechanism (TPRM). The purpose of the Trade Policy Review Mechanism (“TPRM”) is to contribute to improved adherence by all Members to rules, disciplines and commitments made under the Multilateral Trade Agreements, including the SPS Agreement.27 In each report, there is a specific part on “sanitary and phytosanitary measures”, which provide a description of the relevant legal and institutional framework, among which the existing animal health laws and regulations and institutions involved. These reviews therefore are a useful opportunity to understand the domestic veterinary legislation frameworks. It is in this context that the requirement to base national measures on international standards in SPS measures may be addressed, among the other obligations of the SPS Agreement.

However, the reviews are prepared by the WTO Secretariat merely for transparency purposes, in close co-operation with the reviewed country. The WTO Secretariat does not have the authority to conduct an assessment of the legal consistency of domestic policies with the WTO agreements. These reviews do not incorporate systematic assessment of the use of international standards, beyond information already included in notifications to the SPS Committee or concerns raised in the SPS Committee regarding the reviewed countries’ measures. Without a more detailed assessment on countries’ use of international standards, this transparency mechanism does not add evidence for the purposes of the OIE Observatory.

Mechanisms to collect information and support implementation of specific thematic or regional issues

Some regional groupings have independent data collection exercises that may feed into the OIE Observatory as sources of information. This is the case, for example, of the monitoring conducted by the OIE Secretariat itself or by the EU of its Member States’ measures. In addition, the OIE maintain other mechanisms specific to certain thematic issues.

OIE Mechanisms to support implementation in specific regional contexts

The OIE maintain a number of mechanisms to provide trainings on a regional basis and ensure relevance of OIE standards in different contexts. In some cases, these regional platforms are used to gather information about implementation of standards in a specific region.

Regional commissions

Regional commissions were set up at the very outsets of the OIE, in order to identify topics that were of relevance to specific regions. They are composed of representatives of countries from the same region. A “regional bureau” is elected for a mandate of three years, with four representatives of each region.28 This bureau identifies the diseases that are of particular interest to their region, and address specific challenges that the region is facing. In addition, an informal “regional core group” creates a relation between each region and the central governance bodies of the OIE: it is composed of the four bureau Members of each given region, and of two Members of the Council from the same region. The OIE Secretariat supports regional commissions namely through its Regional Representations present in Africa, Americas, Asia and the Pacific, Europe and the Middle East.29 However, OIE Headquarters have only a limited involvement in these activities (two Members of the OIE staff ensure coordination of activities of the five regional commissions).

Each Regional Commission organises a Conference every two years in one of their countries. These Conferences are devoted to the discussion of two technical items and to regional cooperation in the control of animal diseases.

Some regional commissions, under their own initiative, monitor the implementation of standards in their geographic area. For example, the commission for Europe set up a questionnaire to self-evaluate the control of population of stray dogs, to monitor implementation of Chapter 7.7 of the Terrestrial Code, and they are in the process of developing a questionnaire to evaluate implementation of Chapter 7.5 on the slaughtering of animals for human consumption. However, these monitoring initiatives depend on specific funding, and interests in given regions. And despite the rapid pace of interconnectedness that increasingly globalise regional problems, pushing the OIE regional commissions to rethink their purpose, there is so far limited co-ordination among regional commissions to disseminate the same questionnaires across regions and gather comparable evidence on implementation.

Focal point seminars

The OIE holds regional training seminars every two years (pending resources), in eight areas: animal disease notification, wildlife, veterinary products, veterinary laboratories, animal production food safety, animal welfare, aquatic animals and communication. OIE Members are invited to nominate eight national focal points specialised in each of these areas to attend the relevant seminars. One OIE staff Member is responsible for managing focal point seminars under each topic. Funding for the seminars varies considerably across regions.

The focal point seminars can be an opportunity to gather information on the Member’s experience in implementing OIE standards. For example, the focal point training on Veterinary products was used as an opportunity to gather information on antimicrobial resistance related topics from focal points in all different regions. Based on the interactions with National Focal Points, the template of questions for the yearly OIE General survey on antimicrobial agents intended for use in animals was finalised. There is not, however, a centralised approach to gathering information on the implementation of existing standards, as the objective of most seminars is to provide updates on revised or newly developed standards, encourage participation in the standard-setting process, and build networks in line with the Terms of reference for each Focal Point topic.

EU monitoring of EU Member States’ measures

The monitoring of EU Member states’ measures allows for a comprehensive monitoring of existing animal health and disease legislation and practice. This monitoring of conformity with EU legislation is particularly interesting because all information is made available to the public online. In particular, the European Commission develops detailed “country profiles” for each EU Member State on issues of food and food safety, animal health, animal welfare and plant health. Concretely, these are individual pages on the EC website, containing the following information:30

• The five most recently published audit reports by the DG Health and Food Safety in all areas related to health and food, including related to animal health. Member states are expected to present action plans for addressing the shortcomings revealed in these audits;

• The EC assessment of the actions taken by the Member states in response to its audits and audit recommendations, in relation to the action plans set by the Member States. This assessment is presented in the form of a report prepared by DG Health and Food Safety;

• An overview of how controls are organised in the Member states, based on information supplied by them;

• Relevant links to Member states’ websites, providing access to official domestic documentation, including when available, the annual reports on implementation of the action plans to address Commission audit recommendations.

These country profiles provide information on Member-state legislation in relation to EU legislation, rather than directly in relation to OIE standards. In addition, these country profiles go beyond the sphere of animal health. However, all components of the country profile listed above contain a section on animal health, including when relevant references to the legal and institutional framework related to implementing OIE standards. Therefore, the thoroughness of the information gathered and the assessment made by the EC in this regard include detailed evidence that may help build better understanding on implementation of OIE standards.

Mechanisms to monitor implementation on specific thematic issues

The OIE Member countries may choose to put a specific emphasis on certain thematic issues, therefore highlighting implementation of the existing OIE standards in this area. This may be done for example via thematic items raised in the yearly World Assembly of Delegates, or in a more ad hoc manner when there is demand on specific issues.

Monitoring of implementation through technical items at the World Assembly of Delegates (WAD)

The OIE WAD is an opportunity to launch discussions about priority topics high on the international agenda with the entire OIE Membership. Two technical items are raised at most annual WAD meetings:

• One of the technical items is based on the results of a questionnaire developed by experts, and responded by OIE Members. The theme of this technical item is defined at the General Assembly among all regional commissions, in a four-hour session dedicated to identifying such themes, based on proposals by regional Core groups.

• The second technical item is decided in the meeting of the OIE Council in February. To develop analytical work for this technical item, experts may be chosen, namely from the pool of experts of the Collaborating Centres.

While noting survey fatigue among Member Countries, the technical item involving a questionnaire may offer a particularly useful avenue to gather information on implementation of OIE standards. Indeed, as the questionnaires result in an analytical report discussed in the WAD annual meeting, there is strong incentive for Members to respond to the questionnaire making their coverage close to exhaustive. The results of the technical item questionnaires are made publically available in aggregates, but not at the country-level.

A telling example is the questionnaire developed in 2017-18, the results of which were presented at the 86th General Session in May 2018. This questionnaire aimed to gather an overview on the implementation of OIE standards by OIE Member countries in the context of international trade. The responses allow to understand the general approaches OIE Members take to implementation of OIE standards: in particular, the respondents indicate how systematic the consideration of international standards is for them, what sort of procedures are in place to consider international standards, and which OIE normative instruments are mostly used. The results were analysed in a Secretariat paper (Kahn, 2018[23]) and have been synthesised for the purposed of this note in Chapter 3, Annex A.

Monitoring of implementation of certain standards related to anti-microbial resistance (AMR)

AMR is a phenomenon that applies to human, animal and plant health. Therefore, specific procedures have been put in place to monitor antimicrobial resistance, jointly managed by the WHO, OIE and the FAO. In response to interests raised in different international fora (WHO, FAO, OIE), the OIE has been conducting specific monitoring on its standards related to AMR, in particular the use of antimicrobial agents in animals.

The OIE has the following standards applicable on the issue:

• Terrestrial Animal Health Code (Chapters 6.7, 6.8, 6.9, 6.10 and 6.11).

• Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Chapter 3.1).

• Aquatic Animals Health Code (Chapters 6.1, 6.2, 6.3, 6.4 and 6.5).

In addition, the OIE has a specific strategy on antimicrobial resistance in veterinary products (OIE, 2016[24]), and has developed a list of antimicrobial agents of veterinary importance (OIE, 2018[25]).

OIE general survey on antimicrobial agents intended for use in animals

Two specific recommendations of the OIE World Assembly suggested further development of OIE standards related to AMR and to enhance the support for their adoption at the national level:31

“3. The OIE develop a procedure and standards for data quality for collecting data annually from OIE Member Countries on the use of antimicrobial agents in food-producing animals with the aim of creating an OIE global database to be managed in parallel with the World Animal Health Information System (WAHIS).”

“4. OIE Member Countries set up an official harmonised national system, based on OIE standards, for the surveillance of antimicrobial resistance and the collection of data on the use of antimicrobial agents in food-producing animals, and actively participate in the development of the OIE global database.”

Against this impetus, an OIE ad hoc Group on antimicrobial resistance has developed a template for harmonised data collection, and guidance for completing the template.32 The template provides an overview of how many Countries have responded and the level of details that can be provided by each country. When processing responses, the Secretariat uses data from WAHIS to cross-check the responses received through the template. This data collection entails the monitoring of the quantities of antimicrobial agents used as required in Chapter 6.8 of the Terrestrial Code and Chapter 6.3 of the Aquatic Code. The results of the monitoring are presented in an Annual Report prepared by the OIE. The results are aggregates at the global and regional levels, not by individual country.

The AMR studies provide for a significant tool to gather evidence on the country practices related to antimicrobial resistance, falling under standards of the OIE Terrestrial and Aquatic Codes.

Global monitoring of country progress on addressing antimicrobial resistance

The OIE, FAO and WHO Members agreed to a joint Action Plan on AMR in 2015. Among others, countries committed to develop AMR national action plans on the status of AMR in their country. The three organisations monitor the implementation of these national action plans by countries. The monitoring is done via a self-assessment survey prepared by the three organisations, with questions on AMR in plant, animal and human health.33 The questions on animal health make references to specific OIE standards, with links to the right standard (Box ‎2.6).

The first two rounds of monitoring are available online, by country.34 Some specific survey questions developed by the OIE allow to assess implementation of OIE standards, as explicit links to the relevant OIE standards are included in the questionnaire. In addition, the co-ordination among the OIE, FAO and the WHO provides an interesting example of joint data collection on monitoring of standards on a horizontal concern for several organisations.

As this exercise remains limited to three OIE standards, the value of the evidence for the purposes of the OIE Observatory remain limited. In addition, the responses provided by responding countries are very brief, and do not provide evidence on the instruments adopted to implement OIE standards. Finally, the information gathered relies merely on a self-assessment. There is therefore no quality-check by the OIE secretariat on the actual implementation of the relevant OIE standards.

Box ‎2.6. Survey questions with specific references to OIE standards
6.6 Progress with strengthening veterinary services
O	A	No systematic approach at national level to strengthening Veterinary Services.
O	B	Veterinary services assessed and plans developed to improve capacity, through a structured approach such as OIE Performance of Veterinary Services (PVS) Evaluation and PVS Analysis missions.
O	C	Implementation of plan to strengthen capacity gaps in Veterinary Services underway.
O	D	Monitoring of Veterinary Services performance carried out regularly, e.g., through PVS Evaluation Follow Up missions.
O	E	Documented evidence of strong capacity in compliance with OIE standards on the quality of Veterinary Services.1
1 http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_vet_serv.htm, Chapter 3.1: “Terrestrial Animal Health Code”.

7.2 National monitoring system for antimicrobials intended to be used in animals (sales/use)
O	A	No national plan or system for monitoring sales/use of antimicrobials in animals.
O	B	Plan agreed for monitoring quantities of antimicrobials sold for /used in animals, based on OIE standards.1
O	C	Data collected and reported on total quantity of AMs sold for /used in animals and their intended type of use (therapeutic or growth promotion)
O	D	Ono a regular basic, data is collected and reported to the OIE on the total quantity of anticrocrobials sold for/used in animals nationally, by antimicrobial class, by species (aquatic or terrestrial), method of administration, and by type of use (therapeutic or growth promotion)
O	E	Data on antimicrobials used under veterinary supervision in animals are available at farm level, for individual animal species.
1 www.oie.int/index.php?id=169&L=0&htmfile=chapitre_antibio_monitoring.htm, Chapter 6.9: “Terrestrial Animal Health Code”;
www.oie.int/index.php?id=171&L=0&htmfile=chapitre_antibio_quantities_usage_patterns.htm, Chapter 6.3: “Aquatic Animal Health Code”.

Conclusion: Key features of existing mechanisms supporting and monitoring the implementation of OIE standards

A number of internal and external sources of information on country activity in the OIE areas exist, providing a wealth of information upon which the Observatory may tap. These focus almost exclusively on the OIE Codes, and to a more limited extent on OIE Manuals. Country coverage may also differ, depending on the type and objective of the monitoring mechanisms (capacity building vs. transparency for regulatory and trade purposes). The level of the collected information is often the country, although aggregates may be produced. Availability may be subject to country decision.

The mechanisms that have been set up at the OIE to collect data are not primarily directed at monitoring implementation of OIE standards. They nevertheless provide useful information on the implementation of OIE standards at the domestic level, as a collateral of their own objectives. The OIE gathers a mix of input, output and outcome data that may lead to analytical work and assessment to understand the impact of OIE standards.

However, because the objective is not a systematic monitoring of implementation, the information gathered does not necessarily cover all OIE Members or is not directly of interest to such exercise. For example, the country coverage of the most in-depth OIE mechanisms (the PVS) is limited to countries that make a request and has been mostly undertaken by developing countries, owing to its capacity building rationale.

By contrast, the official recognition of disease status has largely focused on developed and emerging countries who have exporting interests. In theory, the detailed scrutiny involved in such recognition may be applied to any OIE Member. In practice, however, the limitation of information to positive disease statuses, combined with the need for substantial resources to conduct the process, have constrained the scope of the mechanism.

Overall, a number of OIE mechanisms may still be tapped into further, in order to obtain more comprehensive evidence on implementation of OIE standards. This is for example the case for the Thematic Items of the World Assembly of Delegates, which take place systematically every year and receive visibility from the entire OIE Membership; focal points seminars may be also an opportunity to gather information on the Members’ experience in implementing OIE standards.

Mechanisms used in other IOs complement the evidence gathered today by OIE mechanisms and may also be used more systematically to complement OIE own mechanisms. This is particularly the case with monitoring conducted by the EU, in a particularly thorough manner for its Member States. In addition, the transparency mechanisms of the WTO may offer an avenue to find out about national measures, which adopt or not OIE standards.

References

[18] Bucher, K. (2017), Analysis of the AI-related trade concerns raised by Member Countries.

[17] 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.

[7] Eurostat (2014), Getting messages across using indicators: A handbook based on experiences from assessing Sustainable Development Indicators, Publications Office of the European Union.

[23] 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), Open Government in Biscay, OECD Public Governance Reviews, OECD Publishing, Paris, https://dx.doi.org/10.1787/e4e1a40c-en.

[4] OECD (2018), OECD Regulatory Policy Outlook 2018, OECD Publishing, Paris, https://dx.doi.org/10.1787/9789264303072-en.

[3] OECD (2017), Towards Open Government Indicators: Framework for the Governance of Open Government (GOOG) Index and the Checklist for Open Government Impact Indicators, OECD Publishing.

[5] OECD (2016), International Regulatory Co-operation: The Role of International Organisations, OECD Publishing.

[2] OECD (2016), The monitoring and evaluation of open government strategies and practices, in Open Government: The Global Context and the Way Forward, OECD Publishing.

[6] OECD (2010), Glossary of Key Terms in Evaluation and Results Based Management.

[13] 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.

[10] OIE (2019), Standard Operating Procedure on the publication of the self-declaration of freedom from diseases of Members Codes: Terrestrial Animal Health Code and Aquatic Animal Health Code, A-Submission of Self-Declarations by Members (Section A of Guidelines), http://www.oie.int/fileadmin/Home/eng/Animal_Health_in_the_World/docs/pdf/Self-declarations/EN_Procedure_self_declaration.pdf (accessed on 6 November 2018).

[25] 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.

[11] OIE (2018), Standard Operating Procedure for official recognition of disease status and for the endorsement of national official control programmes of Member Countries, http://www.oie.int/fileadmin/Home/eng/Animal_Health_in_the_World/docs/pdf/SOP/EN_SOP_Application.pdf (accessed on 6 November 2018).

[12] OIE (2017), Procedures for designation of OIE Reference Laboratories, http://www.oie.int/en/our-scientific- (accessed on 15 November 2018).

[24] OIE (2016), The OIE Strategy on Antimicrobial Resistance and the Prudent Use of Antimicrobials, http://www.oie.int/fileadmin/Home/eng/Media_Center/docs/pdf/PortailAMR/EN_OIE-AMRstrategy.pdf.

[9] OIE (2013), OIE Tool for the Evaluation of Performance of Veterinary Services, PVS Tool, Sixth Edition, http://www.oie.int/fileadmin/Home/eng/Support_to_OIE_Members/pdf/PVS_A_Tool_Final_Edition_2013.pdf.

[21] WTO (2018), Annual Report on the Procedure to Monitor the Process of International Harmonization.

[20] WTO (2018), Annual Report on the Procedure to Monitor the Process of International Harmonization, Note by the Secretariat.

[22] WTO (2016), Annual Report on the Procedure to Monitor the Process of International Harmonization.

[16] WTO (2015), Questionnaire on Transparency under the SPS Agreement, G/SPS/GEN/1382.

[14] WTO (2009), Fifth Triennial Review of the Operation and Implementation of the Agreement on Technical Barriers to Trade Under Article 15.4 G/TBT/26.

[15] WTO (2008), Recommended Procedures for Implementing the Transparency Obligation of the SPS Agreement (Article 7), G/SPS/7/Rev.2.

[19] WTO (2004), Revision of the procedure to monitor the process of international harmonization.

Notes

← 1. Data based on information provided by the OIE Secretariat, listing the standards monitored by existing monitoring mechanisms, against a basis of 389 Chapters of 2018 version of the OIE Terrestrial and Aquatic Codes and Manuals (Terrestrial Code - TC (147), Terrestrial Manual - TM (137), Aquatic Code – AC (65), Aquatic Manual – AM (40) ). See Annex B.

← 2. “Veterinary services means the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and recommendations in the Terrestrial Code and the OIE Aquatic Animal Health Code in the territory. The Veterinary Services are under the overall control and direction of the Veterinary Authority. Private sector organisations, veterinarians, veterinary paraprofessionals or aquatic animal health professionals are normally accredited or approved by the Veterinary Authority to deliver the delegated functions.” OIE Glossary, www.oie.int/index.php?id=169&L=0&htmfile=glossaire.htm#terme_services_veterinaires.

← 3. www.oie.int/index.php?id=169&L=0&htmfile=titre_1.3.htm.

← 4. www.oie.int/index.php?id=171&L=0&htmfile=titre_1.3.htm.

← 5. www.oie.int/en/solidarity/pvs-evaluations/status-of-missions/.

← 6. Their reports are available at www.oie.int/en/solidarity/pvs-evaluations/pvs-evaluation-reports/.

← 7. See PVS Evaluation Report of Canada, p. 5. www.oie.int/fileadmin/Home/eng/Support_to_OIE_Members/docs/pdf/201804_09_final_OIE_PVS_Evaluation_report_Canada_Eng.pdf.

← 8. See for e.g. p. 7 in OIE PVS Evaluation Follow-up Mission Report of Turkey, 2017, p. 7. www.oie.int/fileadmin/Home/eng/Support_to_OIE_Members/docs/pdf/20180307_final_OIE_PVS_FU_report_Turkey.pdf.

← 9. www.oie.int/en/solidarity/veterinary-legislation/status-of-missions/.

← 10. www.fao.org/faolex/en/.

← 11. http://oie.int/fileadmin/pdfs/Overview_of_the_VLSP_Electronic_version.pdf.

← 12. www.oie.int/wahis_2/public/wahid.php/Wahidhome/Home/index/newlang/en.

← 13. www.oie.int/en/for-the-media/press-releases/detail/article/oie-alerts-and-animal-health-information-now-available-on-your-smartphone-or-tablet/.

← 14. There is a reference to Chapter 1.1 (notification of disease) and for two diseases control and prevention measures (“compartmentalisation” and “stamping out”); for the other measures, there is no reference.

← 15. www.oie.int/animal-health-in-the-world/self-declared-disease-status/.

← 16. Until 2017, the publication of self-declarations was done in a bulletin issued four times a year, and self-declarations had to be submitted at specific dates to be published in time. Today, the publication of self-declaration is done online, therefore in a more transparent and timely manner. See list of self-declarations: www.oie.int/en/animal-health-in-the-world/self-declared-disease-status/.

← 17. www.oie.int/en/animal-health-in-the-world/official-disease-status/.

← 18. See art 1.6.1 Terrestrial Code.

← 19. For overview of world distribution of reference laboratories, see www.oie.int/en/scientific-expertise/reference-laboratories/map-and-networks/.

← 20. For full set of criteria, see Guidelines for applicants for OIE Reference Laboratory Status, at www.oie.int/en/our-scientific-expertise/reference-laboratories/guidelines-for-applicants/.

← 21. See Article 2 of Intern Rules of OIE Reference Laboratories, https://www.oie.int/en/scientific-expertise/reference-laboratories/criteria-and-internal-rules/.

← 22. See for example OIE Reference Laboratory Reports Activities, 2017, United Kingdom, for African horse sickness www.oie.int/fileadmin/home/eng/our_scientific_expertise/reflabreports/2017/report_312_2017_african_horse_sickness_united_kingdom.pdf; or OIE Reference Laboratory Reports Activities, 2017, South Africa www.oie.int/fileadmin/home/eng/our_scientific_expertise/reflabreports/2017/report_390_2017_african_horse_sickness_south_africa.pdf.

← 23. Information gathered on http://spsims.wto.org/. This figure accounts only for regular and emergency notifications submitted between 1 January 1995 and 31 December 2018, without counting addenda, corrigenda and revisions to the original notification.

← 24. Interviews conducted by OECD with OIE delegates for the purpose of this study.

← 25. The specific trade concerns raised in the SPS Committee are searchable here: http://spsims.wto.org/en/SpecificTradeConcerns/Search.

← 26. www.wto.org/english/tratop_e/tpr_e/tpr_e.htm.

← 27. Annex 3 of Agreement Establishing the WTO, Para A.

← 28. List of bureau Members: www.oie.int/about-us/wo/oie-regional-commissions/.

← 29. www.oie.int/about-us/wo/oie-regional-representations/.

← 30. http://ec.europa.eu/food/audits-analysis/country_profiles/index.cfm.

← 31. OIE World Assembly of Delegates in 2015 in Resolution No. 26, “Combating Antimicrobial Resistance and Promoting the Prudent Use of Antimicrobial Agents in Animals”, www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/amr/a_reso_amr_2015.pdf.

← 32. Both are available in annexes of OIE Annual Report on the use of antimicrobial agents in animals. www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/AMR/Survey_on_monitoring_antimicrobial_agents_Dec2016.pdf and www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/AMR/Annual_Report_AMR_2.pdf.

← 33. www.who.int/antimicrobial-resistance/global-action-plan/AMR-self-assessment-country-questionnaire-2017-English.pdf?ua=1.

← 34. https://amrcountryprogress.org/.