Resolution of Science-based Disputes Between Applicants and the APVMA
The primary role of the APVMA is to evaluate applications for registration of new agvet chemical products, or variation of the registration details of existing agvet chemical products. An additional important role is to evaluate applications for approval of new active constituents. The APVMA’s evaluation is science-based, taking inputs from the APVMA’s own scientific staff, other Australian government agencies and external reviewers.
Occasionally the interaction and requests for clarification or additional data lead to dispute between the applicant and the APVMA. If a reviewer’s report does not support an application, the applicant may dispute the scientific basis on which the reviewer formed that opinion, and if the APVMA refuses to register a product (or vary registration as the case may be) the applicant may dispute the APVMA’s decision.
This document outlines the stages at which science-based disputes may arise and describes mechanisms for their resolution.
The Agvet Code requires the APVMA to consider the following criteria when evaluating an application for registration, variation to registration, or approval of an active constituent:
- the product or active constituent would not be an undue hazard to the safety of people exposed to it during its handling, or people using anything containing its residues;
- would not be likely to have an effect that is harmful to human beings;
- would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment;
- would not unduly prejudice trade or commerce between Australia and places outside Australia; and
- use of the product according to instructions would be effective.
An application is assigned to an evaluator after technical screening for completeness of data requirements. The evaluator is responsible for managing the evaluation of the product according to the above criteria.
Commonwealth Agency Assessment of Toxicology, OH&S and Environmental Data
The APVMA distributes relevant supporting data and the Part 1 Overview to Commonwealth government agencies and as necessary, the Office of the Gene Technology Regulator, for expert assessment of toxicology, OH&S, and environmental criteria.
State Government or External Reviewer Assessment of Safety and Efficacy Data
According to Commonwealth/State agreements which underpin the National Registration System, individual States may nominate to undertake certain types of safety and efficacy assessments.
If no State nominates to undertake an assessment, the APVMA usually contracts a reviewer from its register of approved reviewers. Reviewers on the APVMA register are experts in their field and may be employed by academic institutions and research organisations, or they may be self-employed. The identity of reviewers remains confidential, and they are required to declare that they have no conflicts of interest.
Animal/crop safety and efficacy data are sent to State Government reviewers or external reviewers as the case may be, for assessment. In some cases, APVMA staff will undertake the safety and efficacy assessment.
Finalisation of the Application
There is normally a great deal of interaction between the APVMA evaluator and the applicant during the course of the evaluation of an application. The APVMA evaluator may request clarification of a detail from the application; the agency or external reviewer may request clarification of a point in the supporting data package, or may request supplementary information. Generally, such additional information is provided in response to a deficiency letter (during screening) or a requirements letter (after assignment).
The Commonwealth agencies, or State Government, or external reviewer as the case may be, produce a report to the APVMA and in certain cases this may be sent to the applicant for comment. The applicant may agree with the report or may disagree with some of the contents. If the report requires further assessment by the Commonwealth agency, State Government or external reviewer as the case may be, the report and any supplementary argument or data from the applicant are returned to the Commonwealth agencies, or State Government, or external reviewer, for a supplementary report or reconsideration of the specific matter under disagreement. The report and any supplementary reports are then finalised.
Once the APVMA evaluator has received all final evaluation reports (toxicology, OH&S, environment, target animal/crop safety and efficacy) he/she synthesises the reports into an internal APVMA document known as the Technical Evaluation and Risk Assessment (TERA), and recommends whether or not the APVMA should register the product.
Before the decision to register/approve (or not) is made
1. Discussion with the APVMA evaluator
This is the earliest, most common, and most effective mechanism for dispute resolution. Discussion can take place by telephone, email, correspondence, and in-person meeting. As described above, disputes about the conclusions in the Commonwealth agency or State Government or external reviewer’s report as the case may be, may be progressed by provision of scientific argument or supplementary data by the applicant.
2. Involvement of a more senior officer (Team Manager or Program Manager)
An applicant may seek this form of dispute resolution if the applicant feels dissatisfied with discussions with the APVMA evaluator. The senior officer may personally review the matter, or seek an internal review of the application by another APVMA evaluator, or Principal Scientist.
After the decision to register/approve (or not) is made
3. Request for internal reconsideration of an APVMA decision
An applicant may request the APVMA to reconsider certain decisions made with respect to an application. The scope of decisions eligible for reconsideration is described fully in s167 of the Agvet Code, and it includes matters relevant to acceptance of an application, registration or variation of registration, approval of active constituents, approval of listed registration, possession of unregistered chemical products, recall notices, permits, and licensing of manufacturers of veterinary chemical products.
The Chief Executive Officer is ultimately the decision-maker in an internal reconsideration, having regard to input from APVMA scientific staff and other experts where appropriate.
4. Review of an APVMA decision by the Administrative Appeals Tribunal (AAT)
Section 167 of the Agvet Code provides that the same scope of APVMA decisions which may be subject to APVMA reconsideration, may also be subject to review by the AAT. The APVMA informs applicants of this fact when it sends a Notice to applicants informing them of an APVMA decision which falls under the scope of s167.
This paper illustrates the range of avenues which are open to resolve science-based disputes between applicants and the APVMA.
The outcomes of applications for registration are primarily decided by the quality and presentation of supporting data. When disputes arise they are often around the fringes of known science and in the absence of relevant supporting data. The APVMA seeks to encourage improvement in the quality of application data through regular seminars, and the publication of guidelines and requirements in the gazette and on the website.
There are a number of consultative forums at which overall APVMA policy with respect to decision-making may be discussed:
- industry consultative forums such as the Industry Liaison Committee (ILC), Industry Technical Committee (ITC);
- industry representative bodies such as Avcare, the Veterinary Medicines and Distributors Association (VMDA) may discuss overall APVMA policy directly with the APVMA, usually at the CEO and Program Manager level.
- the Registration Liaison Committee (RLC) is a forum for discussion of the interaction between the APVMA’s registration function, and the States’ control-of-use function.