Minister for Health and Family Services v Bullivant's Natural Health Products Pty Ltd
[1997] FCA 1287
•25 NOVEMBER 1997
FEDERAL COURT OF AUSTRALIA
ADMINISTRATIVE LAW - Appeal from Administrative Appeals Tribunal - decision to list goods on Register of Therapeutic Goods - whether robot shape of children’s tablets likely to result in tablets being mistaken for confectionery or toys - statutory interpretation.
WORDS AND PHRASES - “likely”
Therapeutic Goods Act 1989 (Cth) ss 3(1), 3(5) and 26(1)
Acts Interpretation Act 1901 (Cth) s 46
Therapeutic Goods Regulations 1990 (Cth) reg 6A
Minister for Immigration and Ethnic Affairs v Wu Shan Liang (1996) 185 CLR 259
MINISTER FOR HEALTH AND FAMILY SERVICES v BULLIVANT'S NATURAL HEALTH PRODUCTS PTY LIMITED
QG 192 of 1996
MERKEL J
MELBOURNE (HEARD IN BRISBANE)
25 NOVEMBER 1997
IN THE FEDERAL COURT OF AUSTRALIA
QUEENSLAND DISTRICT REGISTRY
QG 192 of 1996
ON APPEAL FROM THE GENERAL ADMINISTRATIVE DIVISION OF THE ADMINISTRATIVE APPEALS TRIBUNAL CONSTITUTED BY MISS S A FORGIE, DEPUTY PRESIDENT AND PROFESSOR B SMITHURST, MEMBER
BETWEEN:
MINISTER FOR HEALTH AND FAMILY SERVICES
ApplicantAND:
BULLIVANT'S NATURAL HEALTH PRODUCTS PTY LIMITED
RespondentJUDGE:
MERKEL J
DATE OF ORDER:
25 NOVEMBER 1997
WHERE MADE:
MELBOURNE (HEARD IN BRISBANE)
THE COURT ORDERS THAT:
The appeal be dismissed.
The applicant pay the respondent’s taxed costs of and incidental to the appeal.
Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
IN THE FEDERAL COURT OF AUSTRALIA
QUEENSLAND DISTRICT REGISTRY
QG 192 of 1996
ON APPEAL FROM THE GENERAL ADMINISTRATIVE DIVISION OF THE ADMINISTRATIVE APPEALS TRIBUNAL CONSTITUTED BY MISS S A FORGIE, DEPUTY PRESIDENT AND PROFESSOR B SMITHURST, MEMBER
BETWEEN:
MINISTER FOR HEALTH AND FAMILY SERVICES
ApplicantAND:
BULLIVANT'S NATURAL HEALTH PRODUCTS PTY LIMITED
Respondent
JUDGE:
MERKEL J
DATE:
25 NOVEMBER 1997
PLACE:
MELBOURNE (HEARD IN BRISBANE)
REASONS FOR JUDGMENT
BACKGROUND
The Minister for Health and Family Services (“the Minister”) has appealed to the Court, on the ground of error of law, from the decision of the Administrative Appeals Tribunal (“the AAT”) to list two robot shaped therapeutic tablets under s 26 of the Therapeutic Goods Act 1989 (Cth) (“the Act”). The two tablets, which are supplied by the respondent (“Bullivant’s”), are:
Natural Nutrition Childchew C Calcium Ascorbate 250mg Chewable Tablets (“the Vitamin C tablet”); and
Natural Nutrition Children’s Supplements Chewable Echinacea Complex Children’s Bodyguard tablets (“the Echinacea tablet”).
Initially, a delegate of the Secretary of the Department of Human Services and Health refused to list the tablets on the Australian Register of Therapeutic Goods pursuant to s 26 of the Act. The refusal was confirmed by a delegate of the Minister. Bullivant’s successfully applied to the AAT to review the decisions refusing the listing. The AAT decided that the tablets are to be listed, subject to the assignment of a listing number under s 27 of the Act and any conditions which may be imposed under s 28 of the Act, and remitted the matter to the Minister accordingly.
The central issue arising on the appeal is whether the AAT erred in law in construing and applying reg 6A of the Therapeutic Goods Regulations 1990 (“the Regulations”).
THE ACT
The object of the Act is set out in s 4:
“The object of this Act is to provide, so far as the Constitution permits, for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:
(a)used in Australia, whether those goods are produced in Australia or elsewhere; or
(b)exported from Australia.”
Section 21 prohibits the knowing or reckless supply of therapeutic goods for use in humans unless the goods are registered or listed. Bullivant’s was required to list the Vitamin C and the Echinacea tablets as therapeutic goods under the Act as:
they are goods which are represented to be or are likely to be taken to be for therapeutic use: see s 3(1);
Bullivant’s wished to manufacture or supply them for use in Australia: see ss 20(1)(c) and (d) and 20(2)(c) and (d).
Section 23 provides for applications for registration or listing. Section 26(1) provides:
“(1) Where:
(a)an application is made for the listing of therapeutic goods in relation to a person in accordance with section 23; and
(b)the person has complied with any requirements made by the Secretary under section 31 in relation to the goods;
the Secretary is not to refuse to list the goods in relation to the person except where the Secretary is satisfied that:
…..
(d)the goods are not safe for the purposes for which they are to be used; or
(e)the presentation of the goods is unacceptable;
…....”
Section 3(1) provides that in the Act, unless the contrary intention appears:
“‘presentation’, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.”
Section 3(5) provides:
“For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:
….....
(e)in prescribed cases.”
Regulation 6A of the Regulations provides:
“For the purposes of paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.”
The issues which required resolution in the hearing before the AAT were whether the AAT was satisfied that:
the presentation of the tablets is unacceptable by reason of reg 6A or the introductory words of s 3(5);
the goods are not safe for the purposes for which they are to be used: see s 26(1)(d).
In the appeal to the Court the Minister confined the submissions to error of law as to the construction and application of reg 6A.
THE AAT DECISION
Before the AAT Bullivant’s adduced evidence to the effect that:
the robot shape of the Vitamin C and the Echinacea tablets assisted parents in administering them to children thereby enhancing their use and the resultant benefits;
the presentation of the tablets, including bottling, labelling and the shape, colour, smell, size and taste of the tablets, were such that confusion or unsafe use of the tablets by children was most unlikely to occur;
the tablets did not fall within the terms of reg 6A, s 3(5) or s 26(1)(d).
The Minister adduced evidence that the robot shape of the tablets was likely to confuse children or lead them to believe that the tablets were confectionery or toys and therefore result in unsafe use of the tablets by children. As a consequence, so it was said, the tablets fell within the terms of reg 6A, s 3(5) and s 26(1)(d).
In the present case, the Minister and, therefore on the review, the AAT were not to refuse to list the tablets unless “satisfied” that the goods fell within s 26(1)(d), s 3(5) or reg 6A. Accordingly, a condition of the determination was the Minister’s or the AAT’s “satisfaction”: see Minister for Immigration and Ethnic Affairs v Wu Shan Liang (1996) 185 CLR 259 at 274-276.
After setting out the relevant evidence adduced by the parties in a carefully considered and reasoned decision, the AAT was not satisfied that s 26(1)(d), s 3(5) or reg 6A applied in respect of the tablets and decided that they were to be listed in relation to Bullivant’s under s 26 of the Act.
THE APPEAL TO THE COURT
The Minister ultimately submitted that the AAT erred in law in its application of reg 6A in two respects. The first was that the AAT was required by reg 6A to have regard only to the robot shape of the tablets in determining whether they are unacceptable. The second was that the AAT, in determining that “likely” as used in reg 6A meant “probable”, “as seeming as if it would happen” or “a substantial or real and not remote chance”, applied too high a standard.
A third error, which related to the failure of the AAT to confine its inquiry under reg 6A to the likely effect of the shape of the tablets on children, was advanced. However, in reply, counsel for the Minister accepted that the criticism made of the AAT’s decision in that regard related to its conclusions under s 3(5) rather than reg 6A. Consequently that matter was not pressed.
REGULATION 6A
The Minister submitted that:
reg 6A directs specific attention to be given to “novelty dosage forms in the shape of … robots …”, as a form of presentation which, in itself, can be an unacceptable presentation of goods under the regulation;
accordingly, when considering that aspect of the presentation, reg 6A requires that only that aspect be considered when determining whether that shape is likely to result in the tablets being mistaken for or confused with confectionery or toys;
the AAT erred in law in having regard to other aspects of the tablets, such as size, colour and smell, in concluding that reg 6A did not apply.
The starting point for dealing with the submission is the statutory definition of “presentation” in s 3(1) which directs attention to “the way in which the goods are presented for supply”. Contrary to the view of the AAT, I cannot discern any intention in reg 6A or the statutory scheme by which it is made applicable (ss 26(1)(e) and 3(5)) to exclude the definition in s 3(1), which is made applicable to the Regulations made under the Act by s 46 of the Acts Interpretation Act 1901 (Cth). Indeed, given the obvious purpose of reg 6A of protecting children and the regulation’s close interaction with ss 26(1)(e) and s 3(5), which both use “presentation” in its defined sense, I can see no basis for inferring that a different and narrower meaning was intended in reg 6A. The AAT concluded that as reg 6A referred to labelling and packaging, in contradistinction to presentation, the statutory definition of presentation was impliedly excluded. Whilst aspects of the presentation of goods include labelling and packaging which are referred to in reg 6A, the statutory definition includes all aspects of the way in which goods are presented for supply including “matters relating to” labelling and packaging. In my view the statutory definition, in so far as it relates to labelling and packaging, imports a wider concept than “packaging” and “labelling” as such. Put another way, the collocation of “any labelling, packaging and presentation of therapeutic goods” in reg 6A is intended to give the regulation a wide and ambulatory, rather than a limited or fixed, meaning. The regulation should be construed as embracing all aspects of presentation as defined including labelling, packaging and any other aspect of presentation. That interpretation, which is consistent with the purpose of reg 6A, is put beyond doubt by the consequence specified in reg 6A of goods falling within the regulation, viz, “an unacceptable presentation of the goods”: see also ss 3(5)(e) and 26(1)(e).
However, although the AAT fell into error in not applying the statutory definition, it applied a meaning of “presentation” which did not differ in substance or in the result to the defined meaning. Accordingly, I am not satisfied that the error made any difference to the decision made in that respect.
The AAT also fell into a further error in its application of reg 6A. As a result of treating labelling, packaging and presentation as three separate items, the AAT concluded that it was required to confine itself in its inquiry under the regulation to the item it was considering, ie presentation of the tablets independently of their packaging or labelling. Thus, in considering shape as an aspect of presentation, the AAT concluded that it was required to determine the application of reg 6A by reference to some aspects only of presentation such as size, smell and texture, but excluding other aspects if they related to packaging or labelling.
Regulation 6A is concerned with the safety of children. Its clear purpose is to require that if any aspect of the labelling, packaging or presentation, including shape, of the goods is likely to have the prescribed result, then that is an unacceptable presentation of the goods. The specific identification of novelty forms is to ensure that such shapes alone, being only one aspect of presentation, can give rise to the prescribed result.
Thus, although I accept the first limb of the Minister’s argument, (ie that shape alone can lead to an unacceptable presentation of the goods), I do not accept the next limb that shape only is to be considered. In my view, the issue arising under the regulation, after identification of the aspect or aspects alleged to be likely to have the prescribed result, is the determination of whether the particular aspect or aspects of presentation, labelling or packaging, whatever they may be, is “likely” to have the prescribed result. In determining that matter, the AAT is not confined in its inquiry, which is one of fact. I can see no textual or contextual reason as to why that inquiry is to be limited. What is to be inquired about is what is a likely result. If size, smell, texture, labelling, packaging or any other aspect of presentation of the goods in question is logically probative of that issue, then it is appropriate to consider those matters. It is both artificial and unrealistic to contend that, if those matters tend against the prescribed result they are to be ignored, as was contended on behalf of the Minister, if shape alone tends towards that result.
However, the erroneous confinement by the AAT of its inquiry to certain of the physical aspects of presentation, to which I have referred, could only have assisted the Minister’s case. The labelling and packaging, when considered by the AAT in the context of ss 3(5) and 26(1)(d), were not determined by the AAT to be likely to lead to confusion or to lead children or others into believing the tablets were toys or confectionery or were otherwise not for therapeutic use.
Although I have concluded that the AAT erred in its construction and application of reg 6A I am not satisfied that the consequential errors it made of narrowly defining “presentation” and confining itself to matters that did not involve labelling or packaging made any difference to the result. Indeed the Minister’s case was put on the basis that the AAT’s error was not that it ought to have taken a wider view of the relevant matters to be considered under reg 6A but that it ought to have confined itself to shape alone as the only relevant matter.
For these reasons the appeal on this ground fails.
THE MEANING OF ‘LIKELY’
In its reasons, after considering a number of authorities as to the meaning of “likely” the AAT concluded that:
“64. The Act contains some penal provisions but, the listing provisions with which we are concerned are not penal provisions. They are provisions which are part of the Act’s overall scheme to establish standards of manufacturing, production and distribution of therapeutic goods in a manner which ensures that they are of a certain quality, safe, efficacious and available in a timely fashion. A provision such as regulation 6A is one part of the scheme’s attempts to ensure safety of therapeutic goods. Given that, we have concluded that we should adopt the meaning of “likely” as “probable”, “as seeming as if it would happen” or “a substantial or real and not remote chance”. We have concluded that it does not, in the context of the Act and the non penal provision with which we are concerned, mean “more likely than not”, “a more than a 50% chance of a thing’ happening” or “odds on”. This conclusion is consistent with cases such as Tillmans Butcheries and Boughey’s case. It is not consistent with Krieg’s case but we distinguish that case on the basis that it was concerned with the imposition of an additional liability. That is not so in the context in which we are considering the word.
65. This means that the question we must ask ourselves under regulation 6A is whether it is probable, whether there is there [sic] a substantial or real and not remote chance or whether it seems that the Vitamin C tablets and the Echinacea tablets would be mistaken for or confused with confectionary[sic] or toys.”
It was submitted on behalf of the Minister that the AAT should have held that “likely” as used in reg 6A meant something less than that which it defined as “likely” in the above passage. No authority was cited nor did the Minister offer a clear alternative or substitute definition for “likely” as used in reg 6A.
In my view the submission of the Minister in effect impermissibly substitutes notions of possibility for that of likelihood. There is no basis for that approach in reg 6A. Accordingly, the appeal on the second ground also fails.
CONCLUSION
The Minister has failed on the two grounds ultimately relied upon as constituting errors of law. In these circumstances the appeal is to be dismissed with costs.
I certify that this and the preceding seven (7) pages are a true copy of the Reasons for Judgment herein of the Honourable Justice Merkel
Associate:
Dated: 25 November 1997.
Counsel for the Applicant: Mr L Aitken Solicitor for the Applicant: Australian Government Solicitor Counsel for the Respondent: Mr P McMurdo QC with
Mr P MatthewsSolicitor for the Respondent: Barwicks Wisewoulds Date of Hearing: 13 November 1997 Date of Judgment: 25 November 1997
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