CATCHWORDS ADMINISTRATIVE LAW - review of decision by magistrate to commit for trial - alleged breach of Therapeutic Goods Act - charges that sponsor knowingly imported, supplied and exported goods not listed on the Register - whether Federal Court should entertain review - whether review would substantially decide question if applicant succeeded. CRIMINAL LAW - committal proceedings - when Federal Court should review decision to commit - review only in exceptional circumstances - relevant considerations in decision to review discussed. Administrative Decision (Judicial Review) Act 1977 Therapeutic Goods Act 1989 (Cth): ss16, 17, 20(1) Justices Act (NSW) 1902: s41(2) Yates v Wilson (1989) 168 CLR 338; discussed. Seymour v Attorney-General (Cth) (1984) 57 ALR 68; applied Lamb v Moss (1938) 49 ALR 533; referred to. Sankey v Whitlam (1978) 142 CLR 1; discussed. Forsyth v Rodda (1988) 16 ALD 757; discussed. Smiles v Commissioner of Taxation (1992) 37 FCR 538; discussed. PAN LABORATORIES PTY LIMITED v MAGISTRATE LYON AND THE COMMONWEALTH OF AUSTRALIA No NG 930 of 1994 CORAM: HILL J PLACE: SYDNEY DATED: 13 APRIL 1995 IN THE FEDERAL COURT OF AUSTRALIA ) ) NEW SOUTH WALES DISTRICT REGISTRY ) No NG 930 of 1994 ) GENERAL DIVISION ) BETWEEN: PAN LABORATORIES PTY LIMITED Applicant AND: MAGISTRATE LYON First Respondent THE COMMONWEALTH OF AUSTRALIA Second Respondent CORAM: HILL J PLACE: SYDNEY DATED: 13 APRIL 1995 MINUTES OF ORDER THE COURT ORDERS THAT: 1. The application be dismissed. 2. The applicant pay the costs of the Commonwealth until the commencement of the hearing. 3. The applicant pay the costs of the Director of Public Prosecutions. 4. No order as to the costs of Magistrate Lyon. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules. IN THE FEDERAL COURT OF AUSTRALIA ) ) NEW SOUTH WALES DISTRICT REGISTRY ) No NG 930 of 1994 ) GENERAL DIVISION ) BETWEEN: PAN LABORATORIES PTY LIMITED Applicant AND: MAGISTRATE LYON First Respondent THE COMMONWEALTH OF AUSTRALIA Second Respondent CORAM: HILL J PLACE: SYDNEY DATED: 13 APRIL 1995 REASONS FOR JUDGMENT The applicant, Pan Laboratories Pty Limited ("Pan"), applies to the Court, pursuant to the provisions of the Administrative Decisions (Judicial Review) Act 1977 ("the ADJR Act"), to review a decision made by the first respondent ("the Magistrate") that Pan be committed for trial in the District Court of New South Wales on thirty two charges alleging breaches of the Therapeutic Goods Act 1989 (Cth) ("the Act"). The charges concern events occurring between 25 May 1992 and 24 February 1993. They fall into three categories. The first category alleges breaches of s20(1)(a) of the Act in that Pan as "sponsor" of therapeutic goods knowingly imported those goods into Australia for use in humans contrary to s20(1)(a) of the Act, the goods not being listed on the Register established under the Act. The second category of charges allege breaches by Pan of s20(1)(d) of the Act in that Pan, being a "sponsor" of therapeutic goods, knowingly supplied goods in Australia for use in humans, the goods not being listed on the Register. The third category, which alleges breaches of s20(1)(b) of the Act, charges that Pan, as "sponsor" of therapeutic goods, knowingly exported goods from Australia for use in humans, the goods not being listed on the Register. Six of the charges relate to the first category. The committal proceedings before the Magistrate occupied four hearing days despite admissions made by senior counsel for Pan. The precise terms of those admissions was not before me but, at least, it would not seem that there was any real contest about the fact of import, supply or export by Pan of the relevant goods, being evening primrose oil, originally manufactured in Thailand. At the end of the committal hearing, written submissions were apparently handed up by both sides. On the part of the defence, those written submissions dealt with a legal issue, that being whether listing in the Register established under the Act was required in respect of each particular source of manufacturer. It is not clear, and in any event not relevant to the present proceedings, whether the defence made, in addition, submissions of fact. Written submissions on both fact and law were advanced for the prosecution. After hearing oral submissions the Magistrate accepted the submissions of the prosecution and formed a satisfaction, in accordance with s41(2) of the Justices Act 1902 (NSW). Pan was accordingly committed for trial. That trial has been deferred pending the outcome of the present proceedings. To understand the substance of the charges laid against Pan it is necessary to set out the terms of s20(1) of the Act. That subsection provides as follows: "A person who is the sponsor of therapeutic goods must not knowingly or recklessly: (a) import the goods into Australia for use in humans; or (b) export the goods from Australia for use in humans; or (c) manufacture the goods for supply in Australia for use in humans; or (d) supply the goods in Australia for use in humans; unless: (e) the goods are registered goods or listed goods in relation to the person; or (f) the goods are exempt goods or are the subject of an approval or authority under section 19. Penalty: $24,000." The basic defence on behalf of Pan was that the relevant goods imported, exported or supplied were, in relation to Pan, "listed goods", that is to say, therapeutic goods included in the part of the Register kept under the Act for goods known as "listed goods". The Act provides, in s17, for the maintenance of a Register in two parts, one relating to registered goods and the other related to listed goods. The difference between the two parts is not presently material. The process of obtaining listing involves the making of an application in relation to a particular person: s23; the formation of a satisfaction by the Secretary of certain matters relating to the goods: ss26(1)(c) to (m) and the ultimate listing. The matters of which the Secretary is required to be satisfied include, in the case of goods manufactured in Australia, whether that manufacture is contrary to Pt4 of the Act and, in the case of goods manufactured outside Australia, the satisfactory nature of manufacturing and quality control procedures. Once the decision to list is made, a unique registration or listed number is assigned by the Secretary to the goods: s27(1). The Secretary at the time may, pursuant to s28(1) of the Act, in writing, impose conditions on the listing of the goods. Those conditions may clearly be quite wide. Section 28(2) lists four matters specifically and includes such other matters relating to the goods as the Secretary thinks appropriate. Once goods are listed in the Register they remain included in the Register until their listing is cancelled. The person in relation to whom the goods are registered is obliged to notify the Secretary of certain matters, under s29A. The Secretary is empowered, under s31(1), to seek information relating to the goods, inter alia, in respect of the method and place of manufacture of the goods. Cancellation of listing may come about, under s30(2) of the Act, upon a number of grounds which include a change in the goods so that they become separate and distinct from the goods included in the Register and a failure to comply with a condition to which the inclusion of the goods is subject. The basis of the present application for review as set out in the application to the Court is that, upon the proper construction of the Act the goods, the subject of the charges, were "listed goods". The committal is said, by the applicant, to depend upon a fundamental premise that, even where evening primrose oil is manufactured by different manufacturers there must be a separate and distinct listing in respect of each source of manufacturer. It was submitted that this Court should intervene to review the Magistrate's decision because a decision in favour of the applicant on the point of law would avoid what clearly would be a lengthy and expensive trial. It is said that no detailed consideration of evidence would be necessary to determine the matter, and that the question was a bare question of law which this Court could, and should, determine in the interests of justice. Reference is made to what is said to be the severe consequences to Pan, both in terms of cost and expense, and in terms of business reputation of a lengthy trial which would certainly follow if the committal was not quashed. Counsel for the Director of Public Prosecutions, on the other hand, submitted that there were no circumstances which would warrant the intervention of the Court in the proceedings and, accordingly, as a matter of discretion the Court should decline to give relief to Pan or to entertain the present application. In Yates v Wilson (1989) 168 CLR 338 the High Court, in refusing Mr Yates special leave to appeal from a decision of the Full Court of this Court refusing to intervene to exercise jurisdiction under the ADJR Act in respect of a decision of a magistrate to commit, referred to the undesirability of fragmenting the criminal process as being a powerful consideration which should inhibit this Court from exercising the jurisdiction to review. Decisions of this Court have made it abundantly clear that it will be only in exceptional circumstances that the Court will be prepared to undertake judicial review of a decision to commit. Reference to but a few cases will suffice. In Seymour v Attorney-General (Cth) (1984) 57 ALR 68 at 71, Jenkinson J referred to weighing the public interest in the expeditious resolution of accusations of crime, which will generally point against the Court intervening (cf Lamb v Moss (1983) 49 ALR 533) against the interests of the party seeking judicial review. In Seymour Beaumont J illustrated examples of cases where it may be appropriate for the Court to intervene. One of those was where the information disclosed no offence known to the law: cf Sankey v Whitlam (1978) 142 CLR 1. Such a case, as his Honour observed, would raise a "bare question of law". Otherwise his Honour pointed to the danger of fragmentation. Later, in Forsyth v Rodda (1988) 16 ALD 757 at 758-759, Wilcox J summarised the law to that date and refused to entertain the review sought by Mr Forsyth QC. In Smiles v Commissioner of Taxation (1992) 37 FCR 538, another Full Court of this Court refused to set aside a decision of a single judge not to intervene to review the laying of a prosecution against Mr Smiles. Although different considerations may well arise where the challenge is to the laying of the information rather than to a decision to commit, the decision of the Full Court again emphasised the need for exceptional circumstances before the Court would intervene. Had I been of the view that the present was a case where the resolution of the question of law posed by senior counsel for Pan would, at least if decided favourably to Pan, have meant an end to the prosecution, I would have taken the view that the present was within the category of exceptional cases for, on the face of it, no particular question of fact appeared to arise. However, a closer examination of the decision to commit, in the course of submissions made by counsel, made it clear that this was not really so. In written submissions prepared prior to the hearing of the present application, counsel for the Director of Public Prosecutions had pointed out that "some of the charges concerned Medicap evening primrose oil of a strength for which there was not even an equivalent listing for another manufacturer". Although the reference in this submission appeared to indicate that more than one of the charges was in this category, it was conceded on behalf of the Director that the reference was to one of the charges only. Hence, a decision on the present question of law, if favourable to Pan, would still leave that one charge to be tried in due course and with the attendant publicity to Pan. If that were all, it may well be said that the resultant advantage in the saving of judicial time in the prosecution being only in respect of one rather than thirty two charges, could have characterised the present case as exceptional. It, however, is not all. It is clear from an examination of the legislative scheme of the Act, to which brief reference has already been made, that listing of particular goods has to be "in relation to a particular person". For present purposes this is Pan, as sponsor. However, documents to which I was referred, indicated that, in at least three cases Pan's name did not appear at all in a relevant listing on the Register, whether as sponsor or manufacturer. Thus, in respect of three further charges, the so-called discrete question of law would appear not to resolve any issue in the prosecution. Again it might be thought that a reduction in the number of charges from thirty two to four, in the event of Pan's success in this Court, might be significant enough to be an exceptional matter. The problem does not, however, stop there. In the course of argument I referred senior counsel for Pan to the provisions of s16 of the Act which, on its face, would seem to make it clear that goods of the same formulation but of different names are, for the purposes of the Act, treated as separate and distinct goods. So much was accepted by senior counsel. However, it appeared that there was evidence in respect of imported goods that the relevant evening primrose oil capsules were imported in bulk, at least on some occasions, if not all, before orders had been placed by purchasers. Thus, at the time of import it could not be said that the goods had the same name as those the subject of registration by the purchasers. Thus it would seem that the goods might well have been unlisted goods, irrespective of the source of manufacture. Six of the charges were in this category. I do not know to what extent there is any overlapping between the six charges in this category and the other four charges to which I have already made reference. At the worst, from the point of view of Pan, that would leave it still with ten charges. The same sort of problem can well arise with goods supplied, that is to say sold to customers after importation. The goods supplied may not, at the time of supply, have had the same name as contained in the Register. For example, if title had passed before the capsules had been packaged for the purchaser, and there are suggestions that there were separate charges for packaging, an offence would have been committed irrespective of the question of law which Pan now seeks to have resolved. That will involve a question of fact. Sixteen of the charges relate to supply. I have said enough to indicate that a decision by this Court on the so-called "bare question of law" would not resolve the prosecution as a whole. Irrespective of the legal issue which Pan here seeks to have resolved, the facts may ultimately turn out to demonstrate that Pan was, in any event, guilty of the offences, or some of them, with which it was charged. In these circumstances I am of the view that the present is not such an exceptional circumstance as to require intervention by this Court in the criminal process. In reaching that conclusion I have taken into account the undesirability of fragmenting the criminal process; the delay that would be caused to the trial by this Court deciding the matter with the potential of subsequent appeals; the fact that a decision favourable to Pan might bring the trial to an end, but only in respect of some and certainly not all of the charges; and the fact that to the extent that a favourable decision to Pan would bring an end to some of the charges that would reduce the time occupied by the District Court in hearing the trial. I have also taken into account the fact that some expense might be saved if this Court intervened. However, the fact that a trial must be held, albeit that the number of charges might be reduced, means that intervention by this Court will not eliminate the cost to Pan's reputation of a trial even if the damage to reputation could be partially reduced. Balancing then the public interest against the private interest of Pan, I am of the view, as a matter of discretion, that I should not entertain the application but rather that the trial should proceed before the District Court when all facts relevant to the prosecution can be put before that Court and, should it become necessary, that Court can decide the legal issue the subject of Pan's application for review. I would accordingly dismiss the application and order Pan to pay the costs of it. I should note here that at the hearing and at the request of the Commonwealth, which had originally been made a party as second respondent, I ordered that the Director of Public Prosecutions be substituted for the Commonwealth. That order was made by consent. Accordingly, Pan should pay the costs of the Commonwealth until the commencement of the hearing and the costs of the Director of Public Prosecutions at the hearing. The Magistrate appears not to have entered an appearance at all and, in the circumstances, I would not make any order in respect of the Magistrate's costs. I certify that this and the preceding eleven (11) pages are a true copy of the Reasons for Judgment herein of his Honour Justice Hill. Associate: Date: 13 April 1995 Counsel and Solicitors AJ Sullivan QC with J Stevenson for Applicant: and S Devine instructed by Andrew Thorpe Counsel and Solicitors P Roberts with C O'Donnell for Respondents: instructed by Commonwealth Director of Public Prosecutions Date of Hearing: 31 March 1995 Date Judgment Delivered: 13 April 1995