PROCEDURE FOR OFFICIAL RECOGNITION OF DISEASE STATUS UPDATE ON FOOT AND MOUTH DISEASE

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1 PROCEDURE FOR OFFICIAL RECOGNITION OF DISEASE STATUS UPDATE ON FOOT AND MOUTH DISEASE Introduction In 1994, Member Countries gave the World Organisation for Animal Health (OIE) the responsibility of compiling a list of Member Countries or zones officially recognised as being free from foot and mouth disease (FMD). Official recognition of the disease status of Member Countries is of great significance for international trade since a Member Country may lose or enhance its commercial attractiveness, depending on such recognition. By acquiring and maintaining its official disease-free status, a Member Country can also demonstrate transparency and help to promote animal health and public health worldwide, thereby gaining the trust of its trade partners and of the international community. To this end, a procedure was developed for official recognition by the OIE of the foot and mouth disease- (FMD-) free status of Member Countries and zones. The procedure by which the OIE officially recognises disease status was first developed in 1994 for FMD and progressively extended to other diseases, as decided by the World Assembly of Delegates (World Assembly). The procedure has since been expanded to include official recognition of disease-free status for African horse sickness (AHS) and contagious bovine pleuropneumonia (CBPP), and risk status level for bovine spongiform encephalopathy (BSE), as well as to endorse official control programmes for FMD. (Since the declaration of the global eradication of rinderpest, at the 79th General Session in 2011, the evaluation of rinderpest status is no longer taking place.) Procedure The procedure for official recognition of disease status follows a democratic, transparent and impartial process. A Member Country wishing to be officially recognised as disease-free by the OIE (referred to above) should submit its request to the Director General of the OIE, accompanied by the relevant questionnaire laid out in Chapter 1.6. of the OIE Terrestrial Animal Health Code (Terrestrial Code) and any additional relevant information. The OIE Scientific Commission for Animal Diseases (Scientific Commission) is responsible for assessing, on behalf of the World Assembly, applications (dossiers) from OIE Member Countries for their compliance with OIE standards. The assessment carried out by the Scientific Commission is based on the recommendations P. Blandín

2 Paco Audije formulated by a relevant ad hoc Group (for a specific disease), convened by the Director General of the OIE and composed of world-renowned specialists who have been appointed to review the applications from Member Countries. After each General Session, the Director General informs Member Countries about the next scheduled cycle of ad hoc Group meetings dedicated to official recognition of disease status and endorsement of official FMD control programmes. The OIE meeting cycle runs from May to May, and the World Assembly marks both the beginning and end points. Members of the ad hoc Groups are asked to comply with OIE requirements and procedures on confidentiality, and on the appropriate management of any conflict of interest, as laid down in the OIE's basic texts. The Chairperson of the ad hoc Group and the OIE Secretariat ensure that any members who do have, or appear to have, a conflict of interest of some sort do not take part in the deliberation and decisionmaking on that particular dossier. In addition, the withdrawal of any member of the ad hoc Group is recorded in the report of the meeting. During the evaluation of a dossier, applicant Member Countries can be contacted either during the ad hoc Group meeting or the Scientific Commission meeting, to address specific questions that may arise during the evaluation. If deeper verification is needed, the Scientific Commission may request the Director General to conduct a field mission to the applicant Member Country, to help in reaching a consensus. After the meeting of the Scientific Commission, each applicant Member Country whose dossier has been evaluated by the Scientific Commission receives a letter from the Director General, informing the Member Country of the outcome of the evaluation, along with a record of the evaluation, including the reasons for a positive or negative outcome. If the outcome is negative, the letter indicates existing information gaps and/or specific areas that should be addressed in the future, based on the evaluations of the ad hoc Group and the Scientific Commission. This letter, containing confidential data, is not released in the public domain. Once the Scientific Commission recommends the acceptance of a request by a Member Country, all Member Countries Delegates are informed of the OIE s intention to modify the disease status of that particular Member Country for that particular disease. Member Countries then have 60 days in which to register any objection, based on scientific or technical grounds. Official recognition is then voted on and adopted by at following annual World Assembly. This new official disease status is subsequently recognised by the WTO and should be considered by Member Countries when developing import health measures

3 OIE Member Countries official FMD status map (last update 1 October 2012) (the status of non-contiguous territories is not shown on this map) After a disease outbreak, or when the Scientific Commission determines that the conditions required to demonstrate compliance with the relevant requirements of the Terrestrial Code are no longer being met, a Member Country's disease status may be suspended. The Scientific Commission may decide to reinstate the suspended status when the Member Country submits an application that fulfils all the requirements needed for the recovery of official disease status, as laid out in the relevant chapters of the Terrestrial Code. Suspensions and recoveries of disease status are announced by the Director General in consultation with the Scientific Commission, and the list of these is kept up to date until the adoption of a new Resolution by the World Assembly, the following May. In this context, the Scientific Commission can follow a fast-track process for the suspension and recovery of disease status lost as the result of an outbreak in a country or zone previously recognised as free of disease. Member Country(ies) or zone(s) enjoying disease-free status officially recognised by the OIE must submit an annual reconfirmation form by the end of November every year. An exhaustive description of the procedure is available through standard operating procedures on the OIE website ( fileadmin/home/eng/animal_health_in_the_world/docs/pdf/en_ Standard_Operating_Procedure_final_July_2012.pdf). Current situation an example of foot and mouth disease The lists of Member Countries/zones that are recognised as being free from FMD by the World Assembly are published in the Resolutions of each General Session and available on the OIE website. This site is updated immediately after each General Session and as soon as a suspension or reinstatement is decided upon by the Scientific Commission

4 As an example, the list of Member Countries/zones officially recognised as being free from FMD as of 1 September 2012 consisted of: 66 Member Countries recognised as being FMD-free without vaccination one Member Country recognised as being FMD-free with vaccination 15 zones (in ten different Member Countries) recognised as being FMD-free without vaccination ten zones (in four different Member Countries) recognised as being FMD-free with vaccination (Resolution No. 14, 80th General Session in May 2012, and Bulgaria's reinstatement on 31 August 2012). In addition, three Member Countries have already their official control programme for FMD endorsed (Resolution No. 15, 80th General Session in May 2012). Transparency and confidentiality The OIE, fully recognising the impact of a Member Country's official disease status on its international trade, takes a series of measures to keep the procedure transparent and impartial and to communicate as much as possible (with limitations, due to the need to respect a Member Country's confidentiality). To ensure transparency, the OIE communicates with its Member Countries at several stages of the official recognition procedure and publishes relevant information that could be of use to the International Community on its website. In 2010, to ensure a user-friendly and user-oriented operating procedure for official recognition of disease status, the Scientific and Technical Department of the OIE reproduced the decisions taken in the World Assembly Resolutions and other requirements in a single document and posted it as a Standard Operating Procedure (SOP) on the OIE website. This SOP assists Member Countries wishing to apply the relevant procedures and should facilitate the OIE Delegates' understanding of the steps required. Member Countries gain a transparent view of the overall time line and of the different stages that their application will go through, as well as the fees involved. The SOP is continually being updated to reflect the evolution of the procedure, the inclusion of new diseases and comments from Member Countries. The latest edition of the SOP was published in July Each year, after the General Session, the Director General of the OIE circulates the dates of the meetings of the ad hoc Group responsible for the evaluation of disease status to all Delegates. These dates will determine the deadlines by which application dossiers must be sent to the OIE. Member Countries wishing to apply for official P. Blandín

5 disease status are also reminded about the procedure and invited to liaise with the OIE Secretariat for any additional information required. Once the Scientific Commission has recommended the acceptance of a request by a Member Country, the 60-day commenting period prior to the General Session each year allows OIE Member Countries to react and address any concerns they may have about the application, either to OIE Headquarters or to the applicant Member Country. Such concerns must be based on robust scientific or technical evidence. For higher visibility, the OIE has dedicated a section to official disease status, under the heading Animal health in the world, which is publicly available through the following link: This section contains general information on official recognition and links to the SOP, the detailed list of free Member Countries and zones and any suspensions or reinstatements of Member Country disease status that have occurred in the period between the two General Sessions. Transparency must go hand-in-hand with protecting the confidentiality of information, given the sensitivity of disease status evaluation. The list of Member Countries which have submitted a dossier is kept confidential until the Scientific Commission recommends recognition of their disease-free status. The names of Member Countries that have not met the requirements of the Terrestrial Code, and for which recognition of free status is not recommended by the Scientific Commission, are not released in the public domain; therefore their names and the details of their evaluations are not included in the ad hoc Group/Scientific Commission reports. The obligation of ad hoc Group and Scientific Commission members to sign a confidentiality agreement and a declaration of any conflict of interest is also part of the OIE s commitment to protect the confidential information of Member Countries. The OIE communicates with applicant Member Countries through correspondence between the Director General and the Delegates concerned. Technical contact points can also be contacted at the ad hoc Group as well as at the Scientific Commission meetings, if specific questions are raised. Even though the SOP makes provisions for Member Countries wishing to send experts to meet with the Scientific Commission during its meeting at OIE Headquarters, the Scientific Commission considers that exchanges by and/or teleconference are more cost and time effective. Since lobbying may hinder the principles of transparency and impartiality, applicant Member Country experts may have a time slot to answer the Scientific Commission s questions and clarify any technical points, but cannot take part in the discussion. Paco Audije

6 Conclusion Since 1994, the procedure for official recognition of disease status has evolved. New priority diseases, new expectations and new communication tools are all driving the OIE's efforts to progress and gain further public confidence and visibility. The procedure is constantly being revisited and improved where necessary. For this reason, the Scientific and Technical Department is planning to give more emphasis to essential information posted on the website and make the website more user-friendly. Some of these developments will be seen during the coming year. The list of Member Countries officially recognised by the OIE is also recognised by the WTO and at the international level, since it is based on scientific and robust assessment, led by internationally renowned experts following established procedures and criteria. The possible extension of this procedure to other diseases will further increase the transparency of animal health information and facilitate global trade in animals and animal products Julio Audije