Secretary, Department of Health and Ageing v Export Corporation

REASONS FOR JUDGMENT 1 I have before me a notice of motion filed on 11 January 2010 whereby Export Corporation (Australia) Pty Limited (Export), the respondent in the main proceeding, seeks an order that the applicant, the Secretary of the Department of Health and Ageing (the Department), provide to the respondent particulars in respect of claims made in the statement of claim, as requested in letters dated 20 November 2009 and 16 December 2009, from the respondent's solicitors to the applicant's solicitors. 2 In its statement of claim filed on 31 August 2009 the Department alleges that during January 2007 and May 2008 the respondent imported and supplied up to 50 different types of therapeutic goods in contravention of the Therapeutic Goods Act 1989 (Cth) 'the Act'. The Department further alleges that some of these goods were counterfeit in that the packaging in which they were contained misrepresented the formulation or composition of those goods.

3 At the hearing of its motion, Export pressed only its application for further and better particulars of the physiological process in humans relied on in respect of each of the relevant goods. The reference to physiological process comes from the definition of therapeutic goods in s 3 of the Act. Relevantly, para (a)(i) of the definition states that therapeutic goods are goods that "are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be: (i) for therapeutic use".. Relevantly, therapeutic use is defined as "use in or in connection with … influencing, inhibiting or modifying a physiological process in persons". 4 Export seeks to have the Department identify the physiological process purported to be involved in respect of each of the goods that is the subject of an allegation in the statement of claim. In its written submissions Export argues that it is not possible for it to provide an adequate defence to the allegations made in the statement of claim, in particular the allegation that a physiological process is involved, without the physiological process in question being identified. In reply the Department submits that its submissions in support of the allegations made in the statement of claim will be based only on the presentation of goods, as depicted in photographs that have been provided by way of particulars to Export Corporation. 5 It is important to remember that according to the definition of therapeutic goods, it is not necessary that the goods be actually therapeutic, the emphasis in the definition is on the representation that is made, in this case by their presentation, and how that representation is likely to be taken or to be understood by the ordinary reasonable consumer of the goods in question. On that basis, the Department submits that Export Corporation has all the particulars it needs to formulate its defence and that it is neither necessary nor, in some cases, possible, for the relevant physiological process to be identified. 6 Export's submission might have more substance if the Secretary were to rely, not just on the presentation of the goods, but on "any other reason". In the present circumstances, however, I do not accept Export's submission. Whether or not the material particulars provided by the Department will be sufficient for it to establish the allegations made in the statement of claim is, of course, yet to be decided. Given the limitations to the way in which the Department proposes to substantiate those allegations, I am satisfied that the particulars given will be sufficient for Export to formulate its defence to those allegations. Should it transpire at the hearing of the matter that the Department seeks to go beyond reliance on the way in which the goods are presented, Export would have every right to refer to the assurances given not only before the Court today but also in correspondence between the parties. 7 For these reasons the notice of motion must be dismissed. Export has leave to file written submissions in relation to costs by 31 March 2010. I certify that the preceding seven (7) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Stone.