Advice for industry following Federal Court decision regarding applications involving reference products

In November 2015 a veterinary medicines applicant commenced Federal Court proceedings challenging the validity of decisions made by the Australian Pesticides and Veterinary Medicine Authority (APVMA) to recategorise two applications for registration of veterinary products. Both applications nominated a reference product in order to satisfy certain elements of the statutory criteria for registration of the veterinary products. The matters related to: the ability of the APVMA to recategorise the applications; whether natural justice needed to be given by the APVMA before recategorising the applications, and the methods by which the APVMA dealt with the confidential commercial information of the reference product nominated by the applicant. The decision The Federal Court decision was handed down on 10 June 2016. The Court Orders were that the APVMA’s decision to recategorise the two applications be quashed and that the APVMA is to proceed with determining the applications according to the law. APVMA action 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. To provide certainty for applicants with applications involving both pesticide and veterinary medicine reference products currently with the APVMA or about to be submitted to the APVMA, the following approach will apply during the 21-day appeal period: any application where consent is provided to use the reference product will be assessed using the current process any application already with the APVMA, or being submitted to the APVMA during the appeal period, that nominates a reference product (and does not include consent) will be looked at on a case by case basis to determine the potential risk for disclosure of confidential commercial information applicants who have received notices from the APVMA related to applications involving reference products may discuss their options with the APVMA. It is unlikely that affected applications will be finalised during the 21-day appeal period and the APVMA may not be able to give applicants an estimated finalisation date until after the appeal period. Further advice on the handling of these applications will be provided once the appeal period has ended. The APVMA has carefully considered the above approach in an effort to balance the need to continue, as far as possible, to effectively manage applications during this period while adhering to its commitment to protecting the confidential commercial information of applicants according to legislative requirements. This decision relates specifically to two applications. However, there may be broader implications for applications involving reference products. Until the full implications of the Federal Court decision have been worked through, the APVMA will continue to take a conservative approach to the management of the risk of disclosing confidential commercial information. Advice about handling of previously refused applications will be provided after the appeal period and in consultation with industry. For more information about the status or options for individual applications please contact your case manager.

APVMA, 14 June 2016 ; ;