The Animal Health Alliance is committed to working with governments and all stakeholders to ensure the effectiveness of animal medicines regulation in Australia.
Australian producers, veterinarians and pet owners should have access to innovative medicines to ensure their livestock, thoroughbreds or pets receive the best possible healthcare outcomes. In some cases, Australian primary producers, pet owners and vets are being denied the choice of the most innovative medicines because of undue delays in the Federal regulator’s product assessment and registration process.
New Zealand – a major competitor for our export markets – has a more efficient regulatory system, giving its farmers and livestock producers a better choice of innovative products and a competitive advantage over Australian farmers and livestock producers.
The Animal Health Alliance has identified three main causes of the delays in the Federal regulator’s product assessment and registration process:
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The process is clogged with registration applications for products that in many instances do not proceed to market. The low fee structure for these registrations has resulted in registration delays for innovative products intended for sale in Australia.
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APVMA does not satisfactorily manage their external agencies to ensure that agreed timeframes are adhered to. The registration process also lacks clarity on trade related issues.
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In many cases, the process duplicates the rigorous assessment procedures of the European Union Centralised Registration (EMEA) system and/or the US Food and Drug Administration regime for animal health products.
These delays increase both the time and cost of product development and re-directs resources away from innovative R&D and manufacturing in Australia. The animal health industry supports thousands of Australian R&D, sales, marketing and manufacturing jobs in addition to improving the productivity of our beef, dairy, sheep, pig and poultry industries and providing healthy outcomes for pet and horse owners.
In order to overcome these delays, the Animal Health Alliance is seeking, among other things, an amended user-pays system for the current registration process involving payment of 50% of the fee upon application and the remaining 50% when the registration is finalised.
Further, the Animal Health Alliance argues that animal medicines that have already been approved for use under the EMEA system and/or the US Food and Drug Administration regime should be fast-tracked for Australian use provided there have been no adverse findings.
