Lawrence and Minister for Health and Ageing [2011] AATA 75 (10 February 2011)

Last Updated: 10 February 2011

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION [2011] AATA 75

ADMINISTRATIVE APPEALS TRIBUNAL )

) No 2010/3955

GENERAL ADMINISTRATIVE DIVISION		)
	Re		MARK LAWRENCE

Applicant

And

MINISTER FOR HEALTH AND AGEING

Respondent

DECISION

Tribunal

Mr Egon Fice, Senior Member

Date 10 February 2011

Place Melbourne

Decision

The Tribunal does not have jurisdiction to review this application

...........[sgd] Egon Fice...............
Senior Member
JURISDICTION – Therapeutic Goods Administration – power for review under the Therapeutic Goods Act 1992 – interests affected – notice in writing – custom-made medical device – therapeutic devices – medical devices – criminal sanctions – initial decision – reviewable decision – registration

Allen v Transurban City Link Limited (2001) 208 CLR 167

Re McHattan and Collector of Customs (1977) 18 ALR 154

Administrative Appeals Tribunal Act 1975 ss 25, 27(1)

Development Allowance Authority Act 1992

Therapeutic Goods Act 1989 ss 60(1), 60(2), 60(3), 60(4), 60(5), 41BD(3), 41(HA), 41(MI)

Therapeutic Goods (Medical Devices) Regulations 2002 – 7.1

REASONS FOR DECISION

10 February 2011

Mr Egon Fice, Senior Member

1. Mr Mark Lawrence lodged an application with the Tribunal on 13 September 2010 seeking review of a decision made by an unidentified person in the Therapeutic Goods Administration (TGA), which is part of the Department of Health and Ageing. Mr Lawrence believed the decision was made on about 12 August 2010.
2. As best I was able to understand Mr Lawrence's claim, the determination, which was the subject of his objection, related to a Brachytherapy Kit, which is a medical device, known as RapidStrand Rx. A competitor of Mr Lawrence’s company, known only as Oncura, manufactures this kit. Oncura appears to be a division of, or related to, GE Health. Oncura was not required to register its kit under the Australian Register of Therapeutic Goods (ARTG) for the reason that it was custom made. Mr Lawrence claimed that the RapidStrand Rx kit was therefore given a considerable advantage over the device which Mr Lawrence's company sought to have approved because Mr Lawrence was required to have his device entered on the ARTG.
3. Mr Kenneth Teoh, the principal legal officer with the TGA, submitted that the Minister of the Department of Health and Ageing (the Minister) was of the view that this Tribunal did not have jurisdiction to review Mr Lawrence's matter. This is because the Minister had not made any decisions of the kind referred to in s 25 of the Administrative Appeals Tribunal Act 1975 (AAT Act). Furthermore, Mr Teoh submitted that the actions taken by the TGA in respect of Oncura's medical device did not arise out of an exercise of any power conferred by an enactment. In his opinion, this application by Mr Lawrence should be struck out for want of the Tribunal's jurisdiction to deal with it.
4. In a telephone hearing conducted on 10 November 2010, I directed that both parties have a further 21 days in which to lodge with the Tribunal any further documents upon which they relied for the purposes of determining the jurisdiction question. I also directed that Mr Lawrence have a further seven days to file any material in response to the material filed by the TGA.

THE TRIBUNAL'S JURISDICTION

5. Section 25 of the AAT Act provides that an enactment (another statute) may provide for applications to be made to the Tribunal for review of decisions made in the exercise of powers conferred by that particular enactment. Furthermore, where an enactment makes provision for review by this Tribunal, it must specify the person or persons to whose decisions the provision applies; it may be expressed to apply to all decisions of the person or only to a class of such decisions; and it may specify conditions subject to which the applications may be made.
6. Also important for the purposes of Mr Lawrence's application, are the provisions set out in s 27(1) of the AAT Act regarding persons who may apply to the Tribunal. Relevantly, s 27(1) provides:

(1) Where this Act or any other enactment (other than the Australian Security Intelligence Organisation Act 1979) provides that an application may be made to the Tribunal for a review of a decision, the application may be made by or on behalf of any person or persons (including the Commonwealth or an authority of the Commonwealth) whose interests are affected by the decision.

7. The meaning of the expression persons whose interests are affected by the decision was dealt with by the High Court of Australia in Allen v Transurban City Link Limited (2001) 208 CLR 167. Mr Allen claimed that he was affected by a proposed widening of a freeway as his house was between the existing freeway and the proposed construction work. Mr Allen requested that the Development Allowance Authority, which granted infrastructure borrowing certificates to Transurban, reconsider its decision to issue the certificates. The Authority declined Mr Allen's request as it regarded him not to be a person affected by the decision.
8. Gleeson CJ, Gaudron, Gummow, Hayne and Callinan JJ said, at 174:

17 Transurban correctly submitted that the phrase in s 119(1) of the Authority Act "who is affected by a reviewable decision" has an ambulatory operation. What serves to identify a person as one affected by a reviewable decision will vary having regard to the nature of the reviewable decision itself.

9. The majority held that in the absence of provisions for public inquiries or for public participation in the process of consideration of applications, the system for the provision of certificates was concerned with the provision of certain financial incentives. The legislation was not concerned with broader public interests such as those relating to the environment, engendering social or other aspects of the proposed project. The majority therefore held that Mr Allen was not a person whose interests were affected by the decision to issue the certificates to Transurban.
10. Kirby J, who dissented, noted that contemporary federal legislation continued to reflect the principle of the common law that a party, invoking the jurisdiction of the Court in respect of an alleged interference with the public right, must show that some private right of that party had been interfered with or that such a party has suffered special damage peculiar to him or herself (at 185). However, his Honour said that a closer analysis demonstrated that many federal statutes have adopted different formulae. They have to find the power to initiate court and other proceedings in terms of a broader range of persons and a wider range of circumstances. Kirby J cautioned against approaching this problem as one of an issue regarding standing and said that the problem in a particular case must always take as a starting point the language and structure of the legislative prescription in question.
11. His Honour then dealt specifically with the expression used in s 27(1) of the AAT Act and the provisions in the relevant section of the Development Allowance Authority Act 1992, which referred to reviewable decisions under that Act. His Honour noted that to engage the provisions in the AAT Act, it was not sufficient that the person be affected by the reviewable decision. The focus was on the person's interest. Kirby J also noted that the word interest may mean, depending upon statute, something far beyond traditional property interests with which the common law and equity were typically concerned. His Honour referred to the following passage in Brennan J's judgment in Re McHattan and Collector of Customs (1977) 18 ALR 154 at 157, where he said:

. . . Across the pool of sundry interests, the ripples of affection may widely extend. The problem which is inherent in the language of the statute is the determination of the point beyond which the affection of interests by a decision should be regarded as too remote for the purposes of s 27(1). The character of the decision is relevant, for if the interests relied on are of such a kind that a decision of the given character could not affect them directly, there must be some evidence to show that the interests are in truth affected.

12. Kirby J then indicated that the starting point for analysis in Allen's case was close attention to the requirements of the legislation in question. Adopting that approach, I have set out below my examination of the Therapeutic Goods Act 1989 (TG Act) and the Regulations particularly those dealing with exempt medical devices.
13. Section 60(1) of the TG Act provides that the word decision has the same meaning as in the AAT Act. For the purposes of Mr Lawrence's case, the expression initial decision is defined as a decision of the Secretary or of a delegate of the Secretary:

(a) under the definition of therapeutic devices in subsection 3(1) or under subsection 7(1) or 41BD(3); or
. . .
(h) under Part 4-7 (exempting medical devices from inclusion in the Register); or
. .

14. The expression reviewable decision means a decision of the Minister under subsection (3).
15. The rights of review are set out in sections 60(2), (3) and (4) of the TG Act which provide:

(2) A person whose interests are affected by an initial decision may, by notice in writing given to the Minister:
(a) in the case of a decision particulars of which are required to be notified in the Gazette—within 90 days after those particulars are so notified; or
(b) in any other case—within 90 days after the decision first comes to the person’s notice;
request the Minister to reconsider the decision.
(3) Subject to paragraph 60A(2)(b), the Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and, as a result of that reconsideration, may:
(a) confirm the initial decision; or
(b) revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.
(4) Where a person who has made a request under subsection (2) does not receive notice of the decision of the Minister on reconsideration, or (if applicable) notice that the matter has been remitted under paragraph 60A(2)(b), within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.
(5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Appeals Tribunal for review of that decision.
(6) Where written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice is to include a statement to the effect that a person whose interests are affected by the decision may:
(a) seek a reconsideration of the decision under this section; and
(b) subject to the Administrative Appeals Tribunal Act 1975, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision.
(7) Any failure to comply with the requirements of subsection (5) or (6) in relation to a decision does not affect the validity of the decision.
(8) An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.

16. The first thing that is apparent from the legislation is that the rights of review by this Tribunal are limited. The prerequisites for review are:
    • (a) there must be an initial decision of the Secretary or of a delegate of the Secretary, in Mr Lawrence's case, under s 41BD(3) or Part 4-7 of the TG Act;
    • (b) Mr Lawrence must be a person whose interests are affected by an initial decision;
    • (c) he must give notice in writing to the Minister within the 90 days specified in the Act and request the Minister to reconsider the decision;
    • (d) the Minister must have reconsidered the initial decision and either confirmed that decision or substituted another decision for the initial decision; and
    • (e) if the Minister does not notify the person who requested a review of his decision within 60 days of the making of the request, the Minister is taken to have confirmed the initial decision and the applicant may then seek review by this Tribunal.
17. It is only if the above requirements are satisfied that the applicant may make an application to this Tribunal for review of the Minister's reviewable decision (s60(5) of the TG Act).
18. Section 41BD(3) of the TG Act provides:

(3) The Secretary may, by order published in the Gazette, declare that a particular instrument, apparatus, appliance, material or other article, or that a particular class of instruments, apparatus, appliances, materials or other articles, are not, for the purposes of this Act, medical devices.

19. As I understand the submissions made by Mr Teoh, and after reviewing the evidentiary material provided by the Secretary, the Secretary did not declare that the RapidStrand Rx Brachytherapy Kit was not a medical device for the purposes of the TG Act and therefore, no Order was published by the Secretary in the Commonwealth Gazette. Accordingly, I find that the Secretary did not make an initial decision under s 41BD(3) of the TG Act.
20. Mr Teoh contended that the RapidStrand Rx medical device was exempt from inclusion in the register because of the operation of Part 4-7 of the TG Act. He referred to s 41HA which provides:

(1) The regulations may exempt from the operation of Division 3 of Part 4-11:
(a) all medical devices, except those medical devices of the kinds prescribed for the purposes of this paragraph; or
(b) specified kinds of medical devices.
Note: Division 3 of Part 4-11 contains offences and civil penalty provisions relating to dealing in medical devices that are not included in the Register.
(2) An exemption may be subject to conditions that are prescribed in the regulations.
Note: Breach of the conditions may be an offence: see subsection 41MN(9).
(3) An exemption under paragraph (1)(a) has effect only for classes of persons prescribed in the regulations for the purposes of this subsection.
(4) If the regulations revoke an exemption, the revocation takes effect on the day specified. The day must not be earlier than 20 working days after the day on which the regulations are made.

21. Division 3 of Part 4-11 of the TG Act deals with medical devices not included in the register and other related matters. In particular, s 41MI of the TG Act provides that a person commits an offence if that person imports a medical device into Australia or supplies a medical device in Australia where that device is not included in the register or is not an exempt device, where the device has or will cause harm or injury to a person, or is likely to result in such harm. Therefore, if the medical device is an exempt device, then there is no sanction attached to its importation into Australia or its supply within Australia even though it is not entered in the ARTG.
22. Part 7 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) exempts certain medical devices from inclusion in the register. Regulation 7.1, insofar as it is relevant, provides:

7.1 Exempt devices — general (Act s 41HA)
(1) For paragraph 41HA (1) (b) of the Act, a kind of medical device mentioned in Part 1 of Schedule 4 is exempt from the operation of Division 3 of Part 4-11 of the Act. ...

23. Part 1 of Schedule 4 of the Regulations sets out a number of kinds of medical devices which are exempt devices. Item 1.5 is stated to be: Custom-made medical device.
24. The expression custom-made medical device is defined in the Regulations as follows:

custom-made medical device means a medical device that:
(a) is specifically made in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and
(b) is intended to be used;

(i) only in relation to a particular individual;
(ii) to be used by the health professional to meet special needs arising in the course of his or her practice.

25. On hearing this matter, my initial concern was that an unidentified person within the TGA made a determination that the RapidStrand Rx fell within the description custom-made medical device. However, Mr Teoh submitted that the TGA does not make a decision or determination regarding exempt medical devices. According to Mr Teoh, that is the effect of the legislation.
26. The TGA has, on its website, a statement regarding the regulatory status of Brachytherapy Kits. The statement is dated 8 October 2010 and the TGA notes that three Brachytherapy Kits were, at that time, included in the ARTG. It also pointed out that the RapidStrand Rx Brachytherapy Kit components were included on the ARTG, but the kit itself, which consists of a configuration of seeds and spaces pre-loaded to the medical practitioner’s requirements, was custom made and therefore exempt from the requirement to be entered on the ARTG. It pointed out that it could be legally supplied. This is in accordance with the TG Act.
27. In my opinion, the submissions made by Mr Teoh are plainly correct. The TG Act is structured in such a way as to require medical devices to be registered. Importing medical devices into Australia and supplying those devices to users in Australia is a criminal offence, unless the they are included in the register or are exempt. In other words, if the medical device falls within the description custom-made medical device, it is not an offence to import and supply that device in Australia despite the fact that it is not entered on the register.
28. Unless the TGA was informed that a certain medical device had been imported into Australia, which did not fit the description of a custom-made medical device, it would have no cause to make further enquiries. In fact, Mr Teoh provided to the Tribunal a file note of a meeting at which a number of directors from TGA were present as well as representatives from GE Healthcare, the importers of the RapidStrand Rx Brachytherapy Kit. The file note clearly indicates that the purpose of the meeting was to deal with allegations that the RapidStrand Rx Brachytherapy Kit had been supplied in Australia without obtaining ARTG entry.
29. After some detailed discussion regarding the RapidStrand Rx Brachytherapy Kit, the TGA representatives agreed that the Oncura or GE Healthcare kit was custom made. That finding disposed of the allegation that the kit was being unlawfully imported into Australia. While that necessarily involved a finding or determination that the RapidStrand Rx Brachytherapy Kit was custom-made, and therefore not required to be entered on the ARTG, it was not a decision or determination made under Part 4-7 of the TG Act exempting a medical device from inclusion in the ARTG.
30. As Mr Teoh submitted, the exemption set out in s 41HA which falls under Part 4-7 of the TG Act does not require a determination of any kind to be made by the TGA. It is an exemption from the criminal sanctions set out in Division 3 of Part 4-11 of the TG Act. In other words, it merely provides that the importation of a custom-made medical device is not illegal. Therefore, the TGA has no decision or determination to make in relation to such a device, unless a complaint is made about whether that device falls within the custom-made description. It might then be required to determine that a device does not fit within the exemption and the importer, accordingly, is liable to criminal sanctions. That of course is not the same as making a decision under Part 4-7 of the TG Act exempting a medical device from inclusion in the register. The remaining sections under Part 4-7, that is s 41HB, s 41HC and s 41HD each require the Secretary to be satisfied that certain conditions have been met and if so satisfied, may grant an exemption from entry in the ARTG. Therefore, it cannot be said that the way in which I have interpreted the operation of s 41HA renders nugatory the provisions set out in s 60(1)(h) of the TG Act. Accordingly, I find that neither the Secretary nor a delegate of the Secretary of the TGA made an initial decision under the TG Act in respect of the RapidStrand Rx Brachytherapy Kit. There was therefore no reconsidered decision made by the Minister and there cannot therefore be a reviewable decision as that expression is defined in the TG Act.
31. Given the above finding, no purpose is served by my consideration of whether Mr Lawrence is a person whose interests are affected by an initial decision.

CONCLUSION

32. Section 25 of the AAT Act provides that the Tribunal may only review decisions made under an enactment where that enactment confers power of review on the Tribunal.
33. Although s 60 of the TG Act makes it clear that an application may be made to the Tribunal for a review, that review must be a review of what is described as a reviewable decision. A reviewable decision under the TG Act is an initial decision which has been reconsidered by the Minister.
34. However, although in some cases decisions may be made under Part 4-7 of the TG Act dealing with the exemption of medical devices from registration, no such decision or determination was made in respect of the importation and supply of the RapidStrand Rx Brachytherapy Kit. That is because it was a custom-made device and exempt under the Regulations. It follows that this Tribunal does not have jurisdiction to determine Mr Lawrence’s complaint regarding the importation of the RapidStrand Rx Brachytherapy Kit.
    

I certify that the thirty-four [34] preceding paragraphs are a true copy of the reasons for the decision herein of

Mr Egon Fice, Senior Member

Signed: ......[sgd] Elise Montalto.................................

Associate

Date of Hearing 10 November 2010

Date of Interlocutory Decision 10 February 2011

Representative for the Applicant Self Represented

Representative for the Respondent Mr K Teoh, Department of Health and Ageing - Therapeutic Goods Administration