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Animal Health Alliance (Australia) Ltd will continue to negotiate with the Department of Agriculture, Fisheries and Forestry to deliver the tabling of “Category C" data protection legislation in Federal Parliament. “Category C” legislation deals with the compensation component of data protection.
Data protection is a well established mechanism in the chemical regulatory regimes of most developed countries, including Australia.
Its general aim is to provide to a person (usually a registrant, approval holder or other data owner), who has invested in data in support of one of the following:
- the approval of, or variation of approval /conditions of approval of the active ingredient
- the registration or variation of registration/conditions of registration of a chemical product
- the approval or variation of a label/conditions of approval of a label for a container for a chemical product, a specific period of time during which they may gain an appropriate return for that investment.
During this time period the data protection holder may either have the right to:
- prevent reference to their information in the making of subsequent approvals or registrations which benefit another applicant, registrant or approval holder (data exclusivity)
- have the right to negotiate the terms (including appropriate levels of compensation) under which the APVMA may use their information to benefit others for the purpose of subsequent approvals or registrations.
Within the data protection package being negotiated between industry and government, 3 categories of protection were developed.
Category 1 (all data required for approval and registration of an agvet chemical) and Category 2 (amendments to use and formulation data) data protection legislation has been finalised. However, Category 3 (all data required to support a registered agvet chemical under the Australian Pesticides and Veterinary Medicines Authority (APVMA) chemical review program) has yet to be finalised.
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