B.GOA.2401 - Goat Pain Relief Phase One

Summary

GICA and GIRDAC have endorsed funds to co-fund a Phase 1 project with Animal Health Australia to liaise with regulatory bodies to understand the required steps to achieve product registration for goats and develop a project plan framework to showcase next steps required by industry. This is a priority for the goat industry given there are no current on label pain relief products available to goat producers.

Objectives

The objectives of this project are as follows:
1. Liaise with regulatory bodies, manufacturers and industry to determine the specific needs, research and data requirements required to generate the regulatory package to achieve product registration for pain relief for the goat industry.
2. Conduct industry survey and interviews to determine goat industry user case information. Industry stakeholders consultants including: minimum 10 goat producers representing different regions and sectors (informed by GICA), interviews with vets, or department representatives and online campaign to increase industry responses.
3. Explore and report on engagement and interest with potential commercial partners, AVPMA (Australian Pesticides and Veterinary Medicine Authority), and independent animal ethics groups. Based on the above engagement, develop a regulatory framework map outlining required R&D investments including efficacy, safety, residues studies required for product registration (pain relief) for goats.
4. Provide a report and recommendations based on interviews conducted with clinical research organisations, that explore and report on opportunities, interest, and financial quotes to conduct required goat studies outlined in objective 3.
5. Develop a discovery report including estimation of the size of the goat industry to provide manufacturers with size of opportunity building on the AHA previous goat gain relief technical report.
6. Develop a project framework for future Stage 2 R&D investments which includes developing the regulatory package, as well as confirmed partners, and R&D requirements for registration.

Key findings

Colere Group were contracted to thoroughly investigate the pain medication field and the needs and potential use cases of the Australian goat industry sectors. The following findings and recommendations were provided to industry:
- The husbandry practice that represents the greatest external reputational risk for the goat industry (disbudding), is a low-risk practice for meat or milk residues when considering the use of a range of potential actives.
- Equitable access to pain relief is high priority for the APVMA. Now is the optimal time for the goat industry to engage APVMA and explain industry challenges and a proposed course of action detailing how the goat industry and animal health product manufacturers are going to work together to address those challenges and the critical role of APVMA in this plan.
- Currently, there are no approved label claims for pain medications for goats registered in the EU or USA, and only one or two medications registered globally. This indicates the huge needs gap the industry faces locally and globally as well as the potential market. The APVMA has the opportunity to be a lead global regulator in working with Industry to address an animal welfare gap.
- The goat industry needs to be prepared to demonstrate it is committed to investing in the studies required to apply for an extension of label claim and use instructions (relevant to Tri-Solfen® and or ilium Buccalgesic® depending on the outcomes of discussions with Elanco and Troy Labs respectively).
- The outcome of future discussions with animal health companies will inform the best choice of product for further investigation or investment.
- The schedule developed for future phases of this work is an industry plan for access to pain relief products the includes development study schedules and timelines for new registration application(s) to extend the label claims of Tri-Solfen®, ilium Buccalgesic®, or Metacam®.

Benefits to industry

There is increasing interest from Australian consumers in animal welfare and many of our largest export markets raising their expectations around the welfare credentials of meat and dairy products, the lack of access to pain relief products for the Australian goat industries is a clear and presents reputational risk to the industry. Establishing a set of steps required to achieve product registration for goat pain relief products is a high priority for the goat industry.

MLA action

The findings from this project are being published on the MLA R&D website.

Future research

The findings generated in this project will help to inform the necessary steps required for future R&D investments and appropriate steps required to achieve product registration for pain relief for goats. Discussions with animal health companies will inform the best choice of product for further investigation/investment.

It is recommended a literature review into efficacy and safety in goats as well as any new data on pharmacology, OHS and environment since the primary submission should be undertaken. The sheep and cattle data provided by Troy laboratories cannot readily be extrapolated to goats and further follow up is required with vets and users for their on-farm experience to help determine the dose range to be studied in a dose determination study.

As there is no commercial party supporting this work, commitment from the industry is essential in getting a product to registration. The completion of this phase of the project