APVMA loses lawsuit on CCI

A new legal ruling will force the Australian Pesticides and Veterinary Medicines Authority (APVMA) to reverse an anti-competitive policy position limiting market access for generic chemical products which would have hiked farm input costs.
 

Last week, the Federal Court in Sydney decided the APVMA wasn’t adhering to the law when its attitude towards generic chemical product registrations changed two years ago, due to fears it would create a criminal offence by disclosing commercial in confidence information (CCI).
 

Abbey Laboratories pursued the landmark legal case against the APVMA which focussed on two veterinary chemical product applications made last year which sought the use of CCI, by the APVMA, of products registered to Bayer Australia.
 

On Friday, the Court ruled the APVMA’s decisions to re-categorise the two generic product applications should be quashed, in agreeing with Abbey’s argument that the Authority misconceived its powers and committed a jurisdictional error.
 

Abbey also argued they’d been denied procedural fairness by having no opportunity to be heard on the re-categorising of the applications, before the APVMA made its determination.
 

Speaking to Fairfax Media, Abbey managing director Mick Findlay said in August 2014 the APVMA changed its policy on the use and disclosure of CCI to register generic chemical products, despite the law not changing.
 

Mr Findlay said by deciding to not use internally held product information and data to evaluate generic product registrations, the APVMA had effectively imposed added costs on smaller players, like Abbey, and all others.
 

He said the cost of conducting a residue trial for a new generic animal health product was about $200,000 and about the same amount for an efficacy study.
 

Mr Findlay said for smaller players like Abbey, generating that data required the same amount of work that’s needed to initially register proprietary products, which defeated the purpose of having generic products, in the ag-vet chemical market.

 

APVMA responded that, “The APVMA is considering its prospects for an appeal within the 21 days allowed by the Federal Court Rules. The broader administrative implications for how applications nominating reference products are assessed into the future are also being considered by the APVMA, including what, if any, changes may be needed to how the APVMA handles confidential commercial information. Any proposed changes to the APVMA’s processes will be discussed with industry.”