Aquatic Animal Health Code
Aquatic Animal Health Code |
Quality of Competent Authorities
The quality of Competent Authorities depends on multiple factors that include fundamental principles of an ethical, organisational and technical nature. Competent Authorities should conform to these fundamental principles, regardless of the political, economic or social situation of their country.
Compliance with these fundamental principles by the Competent Authority of an OIE Member Country or Territory (Member) is important to the establishment and maintenance of confidence in its international aquatic animal health certificates by Competent Authorities of other Members.
These fundamental principles are presented in Article 3.1.2. Other factors affecting the quality of Competent Authorities are described in the Aquatic Code (notification, principles of certification, etc.).
The quality of Competent Authorities can be measured through an evaluation, the general principles of which are described in Article 3.1.3. and in Article 3.1.4.
A procedure for evaluating Competent Authorities by OIE experts, on a voluntary basis, is described in Article 3.1.5.
Fundamental principles of quality
Competent Authorities should comply with the following principles to ensure the quality of their activities:
Professional judgement
The personnel of Competent Authorities should have the relevant qualifications, scientific expertise and experience to give them the competence to make sound professional judgements.
Independence
Care should be taken to ensure that the Competent Authority personnel are free from any commercial, financial, hierarchical, political or other pressures which might affect their judgement or decisions.
Impartiality
Competent Authorities should be impartial. In particular, all the parties affected by their activities have a right to expect their services to be delivered under reasonable and non-discriminatory conditions.
Integrity
Competent Authorities should guarantee that the work of each of their personnel is of a consistently high level of integrity. Any fraud, corruption or falsification should be identified, documented and corrected.
Objectivity
Competent Authorities should at all times act in an objective, transparent and non-discriminatory manner.
General organisation
Competent Authorities must be able to demonstrate by means of an appropriate regulatory framework, sufficient financial resources and effective organisation that they are in a position to have control of the establishment and application of aquatic animal health measures, and of international aquatic animal health certification activities. The regulatory framework should be suitably flexible to allow for judgements of equivalence and efficient responses to changing situations. In particular, such frameworks should define and document the responsibilities and structure of the organisations in charge of the control of aquatic animal movements, aquatic animal disease control and reporting systems, epidemiological surveillance and communication of epidemiological information.
A similar demonstration should be made by Competent Authorities when they are in charge of veterinary public health activities.
Competent Authorities should have at their disposal effective systems for aquatic animal disease surveillance, diagnosis and notification of disease problems that may occur in the national territory, in accordance with the provisions of the Aquatic Code. They should at all times endeavour to improve their performance in terms of aquatic animal health information systems and aquatic animal disease control.
Competent Authorities should define and document the responsibilities and structure of the organisation (in particular the chain of command) in charge of issuing international aquatic animal health certificates.
Each position within the Competent Authority that has an impact on their quality should be described.
These job descriptions should include the requirements for education, training, technical knowledge and experience.
Quality policy
Competent Authorities should define and document their policy and objectives for, and commitment to, quality, and should ensure that this policy is understood, implemented and maintained at all levels in the organisation. Where conditions allow, they may implement a quality system corresponding to their areas of activity and appropriate for the type, range and volume of work that they have to perform. The recommendations provided in this chapter describe a suitable reference system, which should be used if a Member chooses to adopt a quality system.
Procedures and standards
Competent Authorities should develop and document appropriate procedures and standards for all providers of relevant activities and associated facilities. These procedures and standards may for example relate to:
programming and management of activities, including international aquatic animal health certification activities;
prevention, control and notification of disease outbreaks;
risk analysis, epidemiological surveillance and zoning;
inspection and sampling techniques;
diagnostic tests for aquatic animal diseases;
preparation, production, registration and control of biological products for use in the diagnosis or prevention of diseases;
border controls and import regulations;
treatments intended to inactivate pathogens in aquatic animal products.
Where there are standards in the Aquatic Code or in the Aquatic Manual, Competent Authorities should comply with these standards when applying aquatic animal health measures and when issuing international aquatic animal health certificates.
Information, complaints and appeals
Competent Authorities should undertake to reply to requests from Competent Authorities of other Members or any other authority, in particular ensuring that any requests for information, complaints or appeals that are presented are dealt with in a timely manner.
A record should be maintained of all complaints and appeals and of the relevant action taken by Competent Authorities.
Documentation
Competent Authorities should have at their disposal a reliable and up-to-date documentation system suited to their activities.
Self-evaluation
Competent Authorities should undertake periodical self-evaluation especially by documenting achievements against goals, and demonstrating the effectiveness of their organisational components and resource adequacy.
A procedure for evaluating Competent Authorities by OIE experts, on a voluntary basis, is described in Article 3.1.5.
Communication
Competent Authorities should have effective internal and external systems of communication covering administrative and technical staff and parties affected by their activities.
Human and financial resources
Responsible authorities should ensure that adequate resources are made available to implement effectively the above activities.
For the purposes of the Aquatic Code, every Member should recognise the right of another Member to undertake, or request it to undertake, an evaluation of its Competent Authority where the initiating Member is an actual or a prospective importer of aquatic animal commodities and/or where the evaluation is to be a component of a risk analysis process that is to be used to determine or review sanitary measures which apply to such trade.
A Member has the right to expect that the evaluation of its Competent Authority will be conducted in an objective and transparent manner. A Member undertaking an evaluation should be able to justify any measure taken as a consequence of its evaluation.
A Member which intends to conduct an evaluation of another Member's Competent Authority should provide notice in writing, and allow sufficient time for the other Member to comply with the request. This notice should define the purpose of the evaluation and details of the information required.
On receipt of a formal request for information to enable an evaluation of its Competent Authority by another Member, and following bilateral agreement of the evaluation process and criteria, a Member should expeditiously provide the Member requesting the evaluation with meaningful and accurate information of the type requested.
The evaluation process should take into account the fundamental principles and other factors of quality laid down in Article 3.1.1. and in Article 3.1.2. It should also take into consideration the specific circumstances regarding quality, as described in Article 3.1.1., prevailing in the countries concerned.
The outcome of an evaluation conducted by a Member should be provided in writing as soon as possible, and in any case within 4 months of receipt of the relevant information, to the Member which has undergone the evaluation. The evaluation report should detail any findings that affect trade prospects. The Member which conducts the evaluation should clarify in detail any points of the evaluation on request.
In the event of a dispute between two Members over the conduct or the conclusions of the evaluation of Competent Authorities, the matter should be dealt with having regard to the procedures set out in Article 3.1.3.
Evaluation facilitated by OIE experts under the auspices of the OIE
The OIE has established procedures for the evaluation of Competent Authorities of Members. Members can make a request to the OIE for an evaluation of their Competent Authority.
The World Assembly of OIE Delegates may endorse a list of approved experts to facilitate the evaluation process.
Under these procedures, the Director General of the OIE recommends an expert(s) from that list.
The expert(s) facilitate(s) the evaluation of the Competent Authority of the Member using the OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool), applied as appropriate to the context of the evaluation.
The expert(s) produce(s) a report in consultation with the Competent Authority of the Member.
The report is submitted to the Director General of the OIE and, with the consent of the Member, published by the OIE.
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