57Explanation of Part

#### 57 Explanation of Part (1) This Part contains provisions that entitle a person who has provided protected information to the APVMA in relation to a protected active constituent or in relation to a protected chemical product, in compliance with a requirement made of the person by the APVMA, to receive compensation from anyone else who wishes the information to be used by the APVMA in connection with an application for the approval, or continued approval, of another active constituent or the registration, or continued registration, of another chemical product. (2) Compensation is not payable in respect of the information unless: (a) the protected active constituent or the protected chemical product is or includes a patentable invention and the term of the patent has ended or is about to end; and (b) the information was obtained because of a trial or laboratory experiment and any of the following apply: (i) the information is of a kind mentioned in paragraph 32(1)(b) and was given to the APVMA in response to a notice under that section; (ii) the trial or laboratory experiment was conducted in response to a notice under section 33; (iii) the information was given to the APVMA in response to a notice under subsection 159(1) for the purposes of subparagraph 159(1)(d)(i), (ii) or (iii). (4) The parties concerned are invited to negotiate the terms of the compensation and provision is made for the appointment of a mediator if the parties are unable to agree and for the terms to be arbitrated if the mediation is unsuccessful. If an arbitration takes place, the arbitrator is to base his or her decision on whichever of the proposals put forward by the parties is considered by the arbitrator to be the most reasonable assessment of the proportion of the cost of producing the information that it is fair for the party wishing to use it to pay to the party who provided it.