Hui v Lane No. Scciv-02-1437

HUI v LANE
[2003] SASC 401
Full Court: Mullighan, Debelle and Gray JJ

MULLIGHAN J I agree that the appeal should be dismissed and I am in substantial agreement with the reasons given by Gray J.
All of the elements of the offences were established by the agreed facts and the only issue is whether the appellant had proved that she was not the sponsor of the goods at the relevant time. She was in the process of exporting, or arranging the exportation of, the goods from Australia. There is no suggestion that she was doing so on behalf of another person. She falls within the definition of “sponsor” in s 3 of the Therapeutic Goods Act 1989 (Cth).
I agree with the conclusion of the learned Judge that there is no reason to construe s 20(1A) so that there can only ever be one sponsor of the goods for all time. Indeed, the language of the section suggests otherwise as it employs the expression “at the time”. Obviously at the time of the manufacture of the goods, if in Australia, the manufacturer is the sponsor at that time. Upon the exporting of the goods, the exporter is the sponsor at that time unless doing so on behalf of some other person.
The admitted facts establish that the appellant was the sponsor of the goods at the time of their export or arrangement to export and the defence is not established by the appellant.
DEBELLE J This is an appeal by leave from the decision of a judge of this Court which dismissed an appeal from a magistrate.
The appellant is a pharmacist operating a retail pharmacy in metropolitan Adelaide. She has been convicted after a trial before a magistrate of 26 offences in relation to the export of therapeutic goods in breach of s 20(1) of the Therapeutic Goods Act, 1989 (Cth) (“the Act”). The offences were found to have been committed between 18 February 2000 and 23 February 2001. The appellant appealed to a judge of this Court who dismissed the appeal. The judge, however, granted leave to appeal confining the grant of leave to one ground, namely, whether the judge had erred in confirming that the appellant had failed to establish the defence available under s 20(1A) of the Act.
During the period over which these offences were committed, the relevant provisions of s 20(1) of the Act were amended. At 18 February 2000, s 20(1) and s 20(1A) were in these terms:
“(1) A person must not intentionally or recklessly:
(a) import therapeutic goods into Australia for use in humans; or
(b) export therapeutic goods from Australia for use in humans; or
(c)manufacture in Australia therapeutic goods for supply for use in humans; or
(d)supply therapeutic 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
(g)the goods are the subject of an approval or authority under section 19; or
(h)the goods are the subject of an approval under section 19A.
Maximum penalty: 240 penalty units.
(1A)It is a defence to a prosecution under subsection (1) if the defendant proves that the defendant was not the sponsor of the goods at the time of the importation, export, manufacture or supply, as the case may be.”
On 30 May 2000, the Therapeutic Goods Amendment Act (No 2) 2000 commenced operation. That Act amended s 20(1) so that it read:
“(1) A person is guilty of an offence if:
(a) the person intentionally:
(i)imports into Australia therapeutic goods for use in humans; or
(ii)exports from Australia therapeutic goods for use in humans; or
(iii)manufactures in Australia therapeutic goods for use in humans; or
(iv)supplies in Australia therapeutic goods for use in humans; and
(b)none of the following subparagraphs applies in relation to the goods:
(i)the goods are registered goods or listed goods in relation to the person;
(ii)the goods are exempt goods;
(iii)the goods are the subject of an approval or authority under section 19;
(iv)the goods are the subject of an approval under section 19A.”
At all material times, the definition of “sponsor” in s 3 of the Act was in these terms:
“ ‘sponsor’, in relation to therapeutic goods, means:
(a)a person who exports, or arranges the exportation of, the goods from Australia; or
(b)a person who imports, or arranges the importation of, the goods into Australia; or
(c)a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);
but does not include a person who:
(d)exports, imports or manufactures the goods; or
(e)arranges the exportation, importation or manufacture of the goods;
on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.”
It is apparent that, although there are differences in the manner in which s 20(1) is expressed, there is no material difference in substance. Neither party contended on the hearing of this appeal that anything turned on the differences in expression.
It was common ground that the appellant was the person who had arranged the export of the goods the subject of the charges and that she was not exporting the goods on behalf of any other person who was, at the time, a resident of, or was carrying on business in, Australia. The prosecution alleged that the appellant was the sponsor of the exportation of the goods. For her part, the appellant contended that she was not the sponsor of the goods at the time of exportation. Thus, the issue in this appeal concerns the meaning and operation of the defence provided by s 20(1A).
In support of her submission that she is not the sponsor as defined, the appellant says that the definition of “sponsor” contemplates the existence of more than one sponsor with the consequence that, if at the time of export a sponsor already exists, she comes within the defence. Implicit in the submission is that the sponsor would be either the manufacturer or importer of the therapeutic goods.
The object of the Act is to provide, so far as the Commonwealth Constitution permits, for the establishment and the maintenance of a national system of control relating to the quality, safety and timely availability of therapeutic goods in Australia whether produced in Australia or elsewhere or exported from Australia: s 4 of the Act. One means by which the Act seeks to establish control is by a system of registration and listing: see Part 3 Division 2 of the Act. That system is backed up by s 20 which makes it an offence to import, export, manufacture or supply therapeutic goods which are not registered or listed to the importer, exporter, manufacturer or supplier, or which are not exempt goods or subject to an approval under either s 19 or s 19A of the Act: s 20(1)(b). Shortly stated, the importer, exporter, manufacturer or supplier of therapeutic goods is guilty of an offence unless the therapeutic goods fall within the exceptions listed in either s 20(1)(e) to (h) of the former Act or in s 20(1)(b) of the present Act, both of which I will call “the listed exceptions”.
It is in that context that s 20(1A) provides that it is a defence if the defendant proves that he or she is not the sponsor of the goods at the time of the importation, export, manufacture or supply.
The definition of “sponsor” makes it clear that a sponsor is the actual exporter, importer or manufacturer of the therapeutic goods except if that person is exporting, importing or manufacturing the goods on behalf of another person who at the relevant time is a resident of Australia or is carrying on business in Australia. Thus, those who are acting as agents of another do not come within the definition of “sponsor”. The definition might also extend to include independent contractors of those who are exporting, importing or manufacturing therapeutic goods but it is unnecessary to determine that issue now. It is apparent from the terms of the definition that the Act proceeds on the footing that there is a sponsor whenever therapeutic goods are exported, imported or manufactured. The plain intent of the definition of “sponsor” is that there will be a sponsor at the time of import, at the time of manufacture and at the time of export. Subject to the exception provided in the definition of “sponsor”, the sponsor will be either the exporter, importer or manufacturer. Thus, the scheme of the Act is that, unless the therapeutic goods fall within any of the listed exceptions, the sponsor is guilty of the offence. So, in the case of the export of therapeutic goods, if the goods do not fall within any of the listed exceptions and if the person charged is the exporter or the person who has arranged the exportation of the goods, that person is liable notwithstanding that there might have been sponsors at the time, say, of the manufacture into Australia or importation of those goods into Australia unless that person is acting, say, as the agent of the exporter. Looked at in another way, an exporter who is a sponsor will be guilty of an offence unless the exporter is able to demonstrate that the therapeutic goods, the subject of the charge, do not fall within one of the listed exceptions.
Mr Wells QC, who appeared for the appellant, sought to establish his argument by submitting that, so long as either an importer or manufacturer has been a sponsor, that satisfied the definition of sponsor. He sought to establish the defence by referring to the fact that one meaning of the noun “sponsor” in ordinary usage is a person who makes himself responsible for another or for something, that is to say, someone who vouches for the person or thing: see Macquarie Dictionary. Thus, he contended, goods exported by the appellant would already have been vouched for, that is to say, sponsored by either a manufacturer or importer. Given that the Act seeks to establish a system to maintain the quality of therapeutic goods sold in Australia or exported from Australia, that object was effected by ensuring that someone had already vouched for therapeutic goods which had either been manufactured in Australia or imported into Australia. A person who vouched for the goods was the sponsor at the time. This attractive argument fails, however, to give effect to the plain meaning of the relevant provisions and cannot prevail.
For these reasons, the appellant’s arguments that she is not a sponsor are without foundation. The appeal must, therefore, be dismissed.
GRAY J: This is an appeal against convictions.
Introduction
The appellant Lee Lin Hui was charged with eight counts of exporting therapeutic goods from Australia contrary to section 20(1)(b) of the Therapeutic Goods Act 1989 (Cth)[1], 17 counts of exporting therapeutic goods contrary to section 20(1)(a)(ii) of the Act[2] and one count of attempting to export therapeutic goods contrary to Section 20(1)(a)(ii) of the Act[3]. On 26 September 2002 Ms Hui was convicted on all counts following a trial before a magistrate. The magistrate observed:
Sub-section (1) of section 20, in its original terms, placed on the prosecution the onus of proving that the person charged with an offence against that sub-section was the sponsor of the therapeutic goods. As a result of the subsequent amendments to the provisions of sub-section (1) and the introduction of sub-section (1A) of section 20, the onus has shifted from the prosecution to the defence. It is now the defendant who has the legal burden of proving that he, she or it was not the sponsor of the goods at the relevant time. Having regard to the wide definition of ‘sponsor’ in sub-section (1) of section 3 of the Act, it appears that the prohibition created by sub-section (1) of section 20 is still directed at the sponsors of therapeutic goods, but the onus of proof has changed.
…
Sub-section (1) of section 20 prohibited the defendant from exporting from Australia, therapeutic goods for use in humans in circumstances where those goods were included in the Register as registered goods but not in relation to her. By contravening that prohibition, the defendant is guilty of an offence against sub-section (1) unless she can avail herself of the statutory defence created by sub-section (1A). In order to invoke that defence she must prove that she was not the sponsor of the goods at the time of the export. As the person who exported the goods she would come within the statutory definition of ‘sponsor’ in sub-section (1) of section 3 unless she was exporting the goods on behalf of another person who, at the time of the exportation, was a resident of, or was carrying on business in, Australia.
In the absence of any indication to the contrary it appears that, in the context of sub-section (1A) of section 20, the word ‘sponsor’ bears the meaning specified in the definition in sub-section (1) of section 3. Contrary to [counsel’s] submission, sub-section (1A) does appear to make sense if the word bears that meaning. In the circumstances of this case, there is some scope for the operation of sub-section (1A), but only if the defendant can prove that, on some or all of the occasions in question, she was exporting, or attempting to export, the goods, as the case may be, on behalf of another person who, at the relevant time or times, was a resident of, or was carrying on business in, Australia.
At the start of this hearing the parties acknowledged that the outcome of the case would depend upon the determination of the legal issues which they raised in their submissions. Having dealt with those legal issues, I turn to the admitted facts and to the facts contained in the certificate tendered pursuant to section 56A of the Act. I am satisfied that those facts have been proved beyond reasonable doubt. I make findings in terms of those facts, without reiterating them in these reasons for judgment. On the basis of those facts, the statutory defence created by sub-section (1A) of section 20 is not available to the defendant in respect of any of any of the 26 charges. Having regard to those facts I am also satisfied beyond reasonable doubt, and I find, that every essential element of each alleged offence has been proved.
[1] An example of counts 1-8 is count 1:
1.On or about the 18^th day of February 2000 at Adelaide in the said State intentionally or recklessly exported therapeutic goods from Australia for use in humans such goods not being registered goods or listed goods in relation to the defendant or exempt goods or goods the subject of an approval or authority under section 19 or 19A of the Therapeutic Goods Act 1989; contrary to Section 20(1)(b) of the Therapeutic Goods Act 1989.
Particulars:
On or about the 18^th day of February 2000 the defendant exported Zantac tablets, Diamicron tablets, Tegretol tablets, Epilim tablets and Propecia tablets from Australia for use in humans.
[2] An example of counts 9-25 is count 9:
9.On or about the 2^nd day of June 2000 at Adelaide in the said State intentionally exported therapeutic goods from Australia for use in humans such goods not being registered goods or listed goods in relation to the defendant or exempt goods or goods the subject of an approval or authority under section 19 or 19A of the Therapeutic Goods Act 1989; contrary to Section 20(1)(a)(ii) of the Therapeutic Goods Act 1989.
Particulars:
On or about the 2^nd day of June 2000 the defendant exported Zantac tablets and Diamicron tablets from Australia for use in humans.
[3] Count 26 provided:
26.On or about the 23^rd day of February 2001 at Adelaide in the said State attempted to intentionally export therapeutic goods from Australia for use in humans such goods not being registered goods or listed goods in relation to the defendant or exempt goods or goods the subject of an approval or authority under section 19 or 19A of the Therapeutic Goods Act 1989; contrary to Section 20(1)(a)(ii) of the Therapeutic Goods Act 1989.
Particulars:
On or about the 23^rd day of February 2001 the defendant attempted to export Zantac tablets, Madopar tablets, Indocid suppositories, Epilim tablets, Zocor tablets, Diamicron tablets, Tegretol tablets, Zyloprim tablets and Efexor tablets from Australia for use in humans.
The Relevant Legislative Provisions
Until 30 May 2000 section 20(1) of the Therapeutic Goods Act provided:
A person must not intentionally or recklessly:
(a)     …;
(b)     export therapeutic goods from Australia for use in humans;
(c)     …;
(d)     …;
unless:
(e)     the goods are registered goods or listed goods in relation to the person; or
(f)      the goods are exempt goods; or
(g) the goods are the subject of an approval or authority under section 19; or
(h) the goods are the subject of an approval under section 19A.
Section 20(1) as amended provides:
A person is guilty of an offence if:
(a)     the person intentionally:
(i)…; or
(ii)exports from Australia therapeutic goods for use in humans; or
(iii)…; or
(iv)…; and
(b)     none of the following subparagraphs applies in relation to the goods;
(i)the goods are registered goods or listed goods in relation to the person;
(ii)the goods are exempt goods;
(iii)the goods are the subject of an approval or authority under section 19;
(iv)the goods are the subject of an approval under section 19A.
At all relevant times the legislation contained section 20(1A):
It is a defence to a prosecution under subsection (1) if the defendant proves that the defendant was not the sponsor of the goods at the time of the … export, …as the case may be.
Section 3(1) of the Act contained definitions relevant to an interpretation of both sections 20(1)b) and 20(1)(a)(ii):
In this Act, unless the contrary intention appears:
…
exempt goods, in relation to a provision of Part 3, means therapeutic goods that are exempted from the operations of that Part (except section 31A and sections 31C to 31F) by the regulations.
listed goods means therapeutic goods that are included in the Part of the Register for goods known as listed goods;
registered goods means therapeutic goods included in the part of Register for goods known as registered goods;
sponsor, in relation to therapeutic goods, means:
(a)     a person who exports, or arranges the exportation of, the goods from Australia; or
(b)     a person who imports, or arranges the importation of, the   goods into Australia; or
(c)     a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);
but does not include a person who:
(d)     exports, imports or manufactures the goods; or
(e)     arranges the exportation, importation or manufacture of the goods;
on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.
therapeutic goods means goods:
(a)     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; or
(ii)for use as an ingredient or component in the manufacture of therapeutic goods; or
(iii)for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
(b)     included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii)or (iii);
and includes goods declared to be therapeutic goods under an order in force under section 7, but does not include:
(c)     goods declared not to be therapeutic goods under an order in force under section 7; or
(d)     goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or
(e)     goods for which there is a prescribed standard in the Australia New Zealand Food standards code as defined in Subsection 3(1) of the Australia New Zealand Food Authority Act 1991; or
(f)    goods which, in Australia or New Zealand, have a tradition for use as foods for humans in the form in which they are presented.
therapeutic use means use in or in connection with:
(a)     preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
(b)     influencing, inhibiting or modifying a physiological process in persons or animals; or
(c)     testing the susceptibility of persons or animals to a disease or ailment; or
(d)     influencing, controlling or preventing conception in persons; or
(e)     testing for pregnancy in persons; or
(f)    the replacement or modification of parts of the anatomy in persons or animals;
The Agreed Facts

An agreed statement of facts was tendered at trial. No other evidence was led by either the Crown or the defence. The agreed facts disclosed that at relevant times Ms Hui was the owner and operator of a pharmacy at Paralowie. She was a qualified pharmacist.
On 1 February 2000 pursuant to the provisions of the Therapeutic Goods Act an investigator obtained and executed a warrant at the Adelaide Mail Exchange. Four boxes containing a total of 60,000 Zantac tablets were seized. Inspection of the boxes revealed that they had been repacked with the labelling facing inwards. The labelling included words “For supply in Australia – export prohibited”. The outsides of the boxes were unmarked. Later investigations suggested that Ms Hui had been provided with incorrect information about her right to export the tablets. No charges were laid.
On 28 February 2001 pursuant to the provisions of the Therapeutic Goods Act an investigator attended at the premises of a freight forwarder in Adelaide. The investigator inspected goods lodged by Ms Hui for export. Pharmaceutical products were contained in 43 sealed cardboard boxes. The goods were listed on an accompanying invoice together with two further products - Efexor tablets and Zyloprim tablets. The goods were photographed. The proposed shipment was resealed and secured.
On 1 March 2001 investigator returned to the premises of the freight forwarder and executed a warrant. The investigator seized the goods lodged for export. By this time the cardboard boxes containing the tablets had been repackaged so that the labelling was facing inward and the outside of the boxes were unmarked. The labelling included the words “For use in Australia only – export prohibited”. Records obtained from the freight forwarder detailed 29 exports of pharmaceutical products by Ms Hui between 17 February 2000 and 23 February 2001.
On 2 March 2001 investigators attended at Ms Hui’s business premises. She admitted her intention to export the goods seized from the freight forwarder the previous day. Another warrant was executed. The investigator seized documents and records relevant to the export of pharmaceutical products.
On 7 March 2001 the investigators returned to Ms Hui’s premises. She produced copies of invoices said to be relevant to her purchase of the goods seized from the freight forwarder.
Following further investigations invoices were seized relating to the therapeutic goods the subject of the 26 counts. The goods listed in those invoices were registered or listed goods in relation to third parties. Neither Ms Hui nor her business had any goods included in the Australian Register of Therapeutic Goods in relation to Ms Hui or her business and had no other approval or authority to export therapeutic goods.
It was agreed that Ms Hui did not export the goods listed on the invoices and referred to in the charges on behalf of persons in whose names the goods were included in the register kept in accordance with the Therapeutic Goods Act.
The total value of the goods the subject of counts 1-25 was $894,211.24. It was agreed that Ms Hui made a profit of not less than 5% on each of the shipments the subject of the first 25 counts.
At trial Ms Hui pleaded not guilty. However she admitted that she had exported and in one instance attempted to export, the goods in question. She also admitted that the goods were therapeutic goods for use in humans and she accepted that the goods were neither exempt goods, or goods the subject of approval or authority under the Act. Ms Hui also agreed that the goods were registered goods and that she was not the person to whom they were registered.
Counsel for Ms Hui contended that Ms Hui was entitled to invoke the statutory defence created by section 20(1A) of the Act. It was said that there could only be one sponsor under the Act and that in the present case the manufacturer was the sponsor, since it had registered the therapeutic goods. Ms Hui was not the sponsor and accordingly she was covered by the statutory defence.
The Decision on Appeal
An appeal to a single judge of this Court was dismissed. The judge concluded:
The appellant argues that there can only be one sponsor of particular therapeutic goods. These goods were manufactured in Australia, and therefore the sponsor is the manufacturer. The appellant was not the manufacturer, and therefore cannot have been the sponsor for the purposes of s 20(1A).
I do not accept that argument either. Neither the definition of “sponsor” nor the provisions of s 20(1A) require a construction that there can only ever be one sponsor of the goods for all time. Subsection (1A) may contemplate that there is only ever one sponsor at one particular time, but it allows for more than one sponsor of the goods. The subsection contemplates that there may be different sponsors at different times. It refers to the ‘sponsor….at the time of the importation, export, manufacture or supply, as the case may be’. On the admitted facts, the appellant was the sponsor of the goods at the time of their export, notwithstanding that there may have been another sponsor who imported the goods into or who manufactured them in Australia. The defence under s 20(1A) was not made out.
Pursuant to a grant of leave Ms Hui has appealed to this court. Leave was restricted to issues arising under section 20 (1A) of the Act.
The Legislative Scheme
The Purpose of the Scheme
The Therapeutic Goods Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods. It covers therapeutic goods supplied in Australia whether those goods are produced in Australia or elsewhere or are exported from Australia. The legislation was intended to strengthen the then existing Commonwealth legislative scheme and provide added protection to consumers of therapeutic goods and to assist Australian industry both locally and internationally.
The second reading speech discloses that in 1989 it was estimated that there were over 14 000 medicinal drug products and 25 000 therapeutic devices on the Australian market. There was concern that many products were entering the Australian marketplace without records being kept or scrutiny. It was considered the risks associated with this practice were unacceptable in an industry where the consequences of a faulty product could be devastating. These risks were said to be exacerbated by globalisation and the large scale production and distribution of therapeutic goods.
Ensuring the quality, safety, efficacy and timely availability of therapeutic goods is the core purpose of the Act. A system of controls has been provided. The term ‘therapeutic goods’ is defined as goods used in the prevention, diagnosis, cure or alleviation of a disease, ailment, defect or injury and includes those goods that are likely taken to be for therapeutic use because of the way they are presented or advertised.
The Therapeutic Goods Act seeks to regulate the conduct of persons having control of therapeutic goods at any particular time. The Act regulates the conduct of manufacturers, importers, exporters and suppliers.
Section 6 of the Therapeutic Goods Act specifies that it applies to corporations[4], people acting in the course of interstate or international commerce[5] or under a law of the Commonwealth relating to the provision of pharmaceutical or repatriation benefits[6]. The Therapeutic Goods Act is restricted in its scope by the Australian Constitution.
[4] s 51(xx) of the Constitution
[5] s 51(i) of the Constitution
[6] s 51(xxiiiA)
The provisions of the Act apply to corporations which import, export, manufacture or supply therapeutic goods and persons who import, export, trade interstate or provide therapeutic goods to the Commonwealth. The national control of therapeutic goods is effected through the determination of standards, the establishment of an Australian Register of therapeutic goods which have been approved for import, export and supply and the licensing of Australian manufacturers of therapeutic goods. The central control mechanism is the register. The register consists of two parts, registered goods and listed goods. Registered goods are those which require an evaluation of their quality, safety and effectiveness before being approved. Listed goods are those of a less hazardous nature which require an assessment of their quality and compliance with any official standard or other specific requirement.
The Therapeutic Goods Act includes three major elements each of which are considered by the World Health Organisation to be necessary for the effective regulation of therapeutic goods. They are a pre-market assessment of products for human use, an assurance that good practices are followed in the manufacture of therapeutic products for human use and a set of standards to be complied with for therapeutic goods for human and animal use. These requirements are mirrored in legislation in European countries, Britain, the United States, Japan and Canada. It is said that the Act provides a level of regulation recognised internationally as necessary to control therapeutic goods. The introduction of this legislation has brought Australia into line with the levels of product assurances exercised and required by major trading partners.
During the course of argument counsel for Ms Hui submitted that there was uncertainty about the proper interpretation of Section 20(1A) of the Act. Section 20(1A) was introduced into the Act by the Therapeutic Goods Amendment Bill of 1996. The explanatory memorandum provided:
Offences under subsection 20(1) of the Act apply only to sponsors. Sponsors can be broadly described as principal importers, exporters and manufacturers, and the definition of “sponsor” does not extend to include those who act on behalf of the principles, except where the principals operate offshore. Currently, in proceedings under this provision, to establish that a person is a sponsor the Crown is required to show, among other things, that there is no agency arrangement. However it is not possible to establish something that does not exist and a fact that is within the knowledge of the sponsor.
The effect of the changes made by Item 11 will be to require a “sponsor” in such a situation to establish that there was an agency arrangement, and that therefore the person did not act as a principal in unlawfully importing, exporting or manufacturing therapeutic goods.
The principal/agent relationship, particularly in cases not involving major corporations, can only be ascertained conclusively through confidential commercial arrangements known only to the parties concerned, to which the Commonwealth is not privy and often precluded from discovery for the purposes of establishing who committed an offence under section 20. Until the identity of the sponsor can be established, it is not possible to lay charges under section 20 of the Act so as to effectively preclude the exportation, importation, supply and use within Australia of unapproved therapeutic goods, including counterfeit drugs.
No change has been made to the nature of the offences under section 20, which apply only to “sponsors”, as defined in subsection 3(1) of the Act.
Section 15(AB) of the Acts Interpretation Act 1991(Cth) authorises the use of extrinsic material to disclose the underlying purpose or object and then to confirm that an evident meaning was intended. Extrinsic aids may also be taken into account where there may be ambiguity about the meaning of a legislation provision[7].
[7] Commissioner of Australian Federal Police v Curran (1984) 55 ALR 697 at 706-7
The Issue on Appeal
Counsel for Ms Hui submitted that the defence provided by section 20(1A) had been made out. Attention was drawn to the use of the words “of the sponsor” in that section. It was submitted that this phrase did not attract the definition of “sponsor” provided in section 3. It was said that the section 3 definition related to the expression “a sponsor” not the expression “the sponsor”. It was argued that the expression “the sponsor” conveyed the meaning of a person who vouched for goods. It was contended that whenever the legislation used the expression “the sponsor” it carried this meaning.
There are difficulties with this contention. On its face there is no reason why the words “the sponsor” used in section 20(1A) should not pick up the section 3 definition of “sponsor”. The ordinary meaning of “the sponsor” in section 20(1A) sits comfortably with the statutory definition. No contrary intention appears. Ms Hui was the exporter of the therapeutic goods. As an exporter she was within the section 3 definition of “sponsor”. Ms Hui could not establish that she was not “the sponsor” for the purposes of making out the statutory defence. The manufacturer of the therapeutic goods was not engaged in export. Ms Hui was not acting as an agent for the manufacturer. Ms Hui was “the sponsor” at the time of export.
The effective control of therapeutic goods requires control over those goods which are to be exported. Control is best effected by regulating the activities of an exporter. If Ms Hui wished to engage in export she could have sought to be registered in respect of the goods for that purpose.
The appropriateness of the literal or ordinary meaning of “sponsor” is confirmed by the explanatory memorandum identifying the mischief addressed by section 20(1A) of the Therapeutic Goods Act. As earlier noted the purpose of introducing section 20(1A) into the legislation was to provide a defence to a person acting as “sponsor’s” agent. The section provides that a defendant carries the onus of establishing agency. The mischief to be addressed specifically by this section was the difficulty faced by the Crown in proving agency when the relevant information lay solely within the knowledge of a defendant.
Once it is accepted that the Therapeutic Goods Act regulates the conduct of persons with control of therapeutic goods at a point of time it can be seen that there is no substance in the appellant’s submission. The judge was correct to dismiss the appeal.
Conclusion
The agreed facts established that Ms Hui was the exporter of the goods the subject of counts 1 to 25. She was intending to export the goods the subject of count 26. As an exporter Ms Hui was the sponsor unless she could establish a relevant agency relationship. It was an agreed fact that she was not acting as an agent. The goods were not “registered goods or listed goods in relation to Ms Hui”.
This appeal should be dismissed.
JUDGMENT CITATIONS LISTED IN ORDER OF APEARANCE IN JUDGMENT
1      An example of counts 1-8 is count 1:
1.On or about the 18^th day of February 2000 at Adelaide in the said State intentionally or recklessly exported therapeutic goods from Australia for use in humans such goods not being registered goods or listed goods in relation to the defendant or exempt goods or goods the subject of an approval or authority under section 19 or 19A of the Therapeutic Goods Act 1989; contrary to Section 20(1)(b) of the Therapeutic Goods Act 1989.
Particulars:
On or about the 18^th day of February 2000 the defendant exported Zantac tablets, Diamicron tablets, Tegretol tablets, Epilim tablets and Propecia tablets from Australia for use in humans.
2      An example of counts 9-25 is count 9:
9.On or about the 2^nd day of June 2000 at Adelaide in the said State intentionally exported therapeutic goods from Australia for use in humans such goods not being registered goods or listed goods in relation to the defendant or exempt goods or goods the subject of an approval or authority under section 19 or 19A of the Therapeutic Goods Act 1989; contrary to Section 20(1)(a)(ii) of the Therapeutic Goods Act 1989.
Particulars:
On or about the 2^nd day of June 2000 the defendant exported Zantac tablets and Diamicron tablets from Australia for use in humans.
3      Count 26 provided:
26.On or about the 23^rd day of February 2001 at Adelaide in the said State attempted to intentionally export therapeutic goods from Australia for use in humans such goods not being registered goods or listed goods in relation to the defendant or exempt goods or goods the subject of an approval or authority under section 19 or 19A of the Therapeutic Goods Act 1989; contrary to Section 20(1)(a)(ii) of the Therapeutic Goods Act 1989.
Particulars:
On or about the 23^rd day of February 2001 the defendant attempted to export Zantac tablets, Madopar tablets, Indocid suppositories, Epilim tablets, Zocor tablets, Diamicron tablets, Tegretol tablets, Zyloprim tablets and Efexor tablets from Australia for use in humans.
4 s 51(xx) of the Constitution
5 s 51(i) of the Constitution
6      s 51(xxiiiA)
7Commissioner of Australian Federal Police v Curran (1984) 55 ALR 697 at 706-7
Gardner Smith Pty Ltd v Collector of Customs (Vic) (1986) 66 ALR 377 at 383-4
Re Australian Federation of Construction Contractors; Ex Parte Billings (1986) 68 ALR 416 at 420

Gardner Smith Pty Ltd v Collector of Customs (Vic) (1986) 66 ALR 377 at 383-4
Re Australian Federation of Construction Contractors; Ex Parte Billings (1986) 68 ALR 416 at 420

[2003] SASC 401

11 December 2003