Aquaculture producers will have faster access to vital veterinary medicines, saving time and money, as the result of a key FRDC investment.
An ambitious project to improve the aquaculture industry’s access to veterinary medicines has already helped progress 15 new minor use permits since it began in 2021. The project has also been successful in prioritising up to $375,000 in government funding to help gather the necessary data required for the permits.
By comparison, previous minor use permits for new aquatic veterinary medicines have been known to take several years and cost hundreds of thousands of dollars – even up to $1 million – for a single-use application.
Dr Shane Roberts from the Department of Primary Industries and Regions (PIRSA) and in association with the University of Adelaide, is leading the FRDC-supported project, working with PIRSA’s Dr Jessica Buss as project officer.
Dr Shane Roberts
The success of minor use permits to date is an important achievement for the FRDC-supported project called ‘Improving the availability of safe and effective veterinary medicines for Australia's seafood industry’ (2020-094).
“The project is helping to close the gap between industry and regulators on how to efficiently access safe and effective medicines to continue supporting fish welfare and production.”
Addressing data gaps
By nationally coordinating applications, the aim is to prevent duplication while effectively gathering the data needed to support applications. It is an issue highlighted in Australia’s strategic plan for aquatic animal health (AQUAPLAN 2022-2027).
Shane says in the past minor use applications to the Australian Pesticides and Veterinary Medicines Authority (APVMA) have been a somewhat disjointed and lengthy process.
“Individual companies or industry sectors may collect the same data and submit their own applications. This leads to inefficiencies, duplication, and restrictive permits. In some cases, the permits are even too restrictive for the original applicant because some use aspects were not anticipated when submitted.”
Already, the project has supported industry access to minor use permits and registrations. This has been done by identifying priority medicines, seeking funding for data collection, sharing information and helping overcome regulatory challenges. This includes supporting 40 minor use permits currently in existence and eight registrations for use in aquaculture. Of those, 32 minor use permits have been renewed or new permits issued since the start of the project.
Prioritising medicines
To understand aquaculture’s veterinary medicine priorities, the project team undertakes a ‘national callout’ each year for veterinarians, industry, researchers and jurisdictional governments.
From this information, funding is then sought from the annual Commonwealth AgVet Assistance Grants. These grants, available to Research and Development Corporations allow researchers to collect the data needed by the regulatory system to approve access to new, innovative, and potentially safer agricultural and veterinary medicine products.
Shane says to date this FRDC project has applied for and prioritised $375,000 to allow researchers to collect data to progress five separate aquatic veterinary medicines across several sectors.
These medicines are:
- Toltrazuril (antiprotozoal/anticoccidial/anthelmintic) - to treat susceptible parasite infections in marine and freshwater finfish.
- Oxytetracycline (antibiotic) - to treat susceptible bacterial infections in marine and freshwater crustaceans.
- Chloramine-T (broad spectrum chlorinated disinfectant) – to treat susceptible parasite or bacterial infections in marine and freshwater finfish.
- Trimethoprim-sulfadiazine (antibiotic/antimicrobial) - to treat susceptible bacterial infections in marine and freshwater finfish.
- Isoeugenol (sedative) – for marine and freshwater crustaceans.
Each priority medicine identified becomes an FRDC-supported project via its expression of interest process.
“Essentially each project receives an equal share of the assistant grant and becomes a separate project. The researchers and veterinarians collect data to contribute to coordinated applications to the APVMA for minor use permits.”
The next national call-out for veterinary medicine priorities will occur in the coming months, with priorities submitted to the Commonwealth AgVet Assistance Grants forum.
Off-label medicines
Seeking and securing research funds for priority medicines is just one part of the broader FRDC project, with off-label medicine use also key.
Shane says that off-label medicine use is very important when minor use permits, or registered products, are not available.
“This is particularly the case for emergency disease outbreaks, that have implications for welfare, health, and production but also for experimental use to help with data collection,” he explains.
As Australia’s aquaculture industry is relatively young, new diseases are being identified and require new treatments.
“More than 20 times as many species are farmed in aquaculture worldwide compared to terrestrial farming. There are also continual innovations involving new species and farming methods. With this comes new disease challenges, which are the biggest limitation to aquaculture growth worldwide.”
A key issue with off-label medicine use is that provisions can vary between Australian fisheries jurisdictions.
In South Australia, the state’s regulatory framework manages off-label use through dedicated aquaculture legislation which ensures safety for consumers, aquatic livestock, and the environment.
“So, as a project objective, we are documenting how we do this in South Australia. The findings, which will be published in a peer-reviewed journal soon, will help other states and territories with their decisions on off-label use.”
The project is also supporting the Aquatic Veterinary Medicines Working Group and has helped progress AQUAPLAN 2022-2027’s activity in minor use applications.
Future planning
Shane explains that this work is vital to help the aquaculture sector grow.
“Here in Australia, the limited availability of permitted and registered veterinary medicines is an ongoing and complex problem.
“That is compounded by being a relatively young primary industry with constant innovations, which can mean new diseases and health issues that require new treatments.
“We know that veterinary medicines play a valuable role in ensuring animal health, welfare and production, but must be used safely to reduce risks to consumers and the animals being treated, plus ensure market access while avoiding potential harm to the environment.”
The project is proving to be pivotal in addressing these issues.
In November 2022, project investigators held a national workshop with aquaculture stakeholders to discuss future coordination options. Outcomes from the workshop will inform the national coordination of veterinary medicines beyond the life of this project.
An updated industry ‘snapshot’ of available permits and registrations in aquaculture will be released later in the year.
More information
Shane Roberts, shane.roberts@sa.gov.au
This reflects R&D Plan Outcomes 2, 3 and 4
