Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd (No 2)

Case [2012] FCA 463


FEDERAL COURT OF AUSTRALIA

Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd (No 2) [2012] FCA 463

Citation: Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd (No 2) [2012] FCA 463
Parties: SECRETARY, DEPARTMENT OF HEALTH AND AGEING v EXPORT CORPORATION (AUSTRALIA) PTY LTD ACN 009 441 632
File number: ACD 38 of 2009
Judge: PERRAM J
Date of judgment: 8 May 2012
Legislation: Therapeutic Goods Act 1989 (Cth) s 19D(1)(a)(i)
Cases cited: Australian Competition and Consumer Commission v MSY Technology Pty Ltd [2012] FCAFC 56
Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd [2012] FCA 42
Date of hearing: 28 June 2011
Place: Sydney (Heard in Canberra)
Division: GENERAL DIVISION
Category: No catchwords
Number of paragraphs: 6
Counsel for the Applicant: Mr TM Howe QC, Mr TM Begbie
Solicitor for the Applicant: Australian Government Solicitor
Counsel for the Respondent: Mr AJ Payne, Mr SJ Free
Solicitor for the Respondent: McLachlan Thorpe Partners

IN THE FEDERAL COURT OF AUSTRALIA

AUSTRALIAN CAPITAL TERRITORY DISTRICT REGISTRY

GENERAL DIVISION

ACD 38 of 2009

BETWEEN:

SECRETARY, DEPARTMENT OF HEALTH AND AGEING
Applicant

AND:

EXPORT CORPORATION (AUSTRALIA) PTY LTD ACN 009 441 632
Respondent

JUDGE:

PERRAM J

DATE OF ORDER:

8 MAY 2012

WHERE MADE:

SYDNEY (HEARD IN CANBERRA)

THE COURT DECLARES THAT:

1.In the period 1 January 2007 to 2 October 2009, Export Corporation contravened section 19D(1)(a)(iv) of the Therapeutic Goods Act 1989 (Cth) by supplying in Australia therapeutic goods for use in humans as specified in Schedule B to the Further Amended Application, in circumstances where the therapeutic goods were not listed on the Australian Register of Therapeutic Goods and none of the subparagraphs in section 19D(1)(b) applied.

THE COURT ORDERS THAT:

2.All orders made in this matter may be entered forthwith.

Note:   Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.


IN THE FEDERAL COURT OF AUSTRALIA

AUSTRALIAN CAPITAL TERRITORY DISTRICT REGISTRY

GENERAL DIVISION

ACD 38 of 2009

BETWEEN:

SECRETARY, DEPARTMENT OF HEALTH AND AGEING
Applicant

AND:

EXPORT CORPORATION (AUSTRALIA) PTY LTD ACN 009 441 632
Respondent

JUDGE:

PERRAM J

DATE:

8 MAY 2012

PLACE:

SYDNEY (HEARD IN CANBERRA)

REASONS FOR JUDGMENT

  1. I gave judgment in this matter on 3 February 2012: Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd [2012] FCA 42. On 24 January 2012, I made orders to give effect to the conclusions therein.

  2. In the judgment, I concluded that Export Corporation should pay pecuniary penalties to the Commonwealth in the amount of $3,127,150. These penalties were imposed on account of 80 contraventions of s 19D(1)(a)(i) of the Therapeutic Goods Act 1989 (Cth) engaged in by Export Corporation in the period 19 January 2007 to 9 May 2008 (which were admitted to by Export Corporation).

  3. In addition to civil penalties, my judgment also considered the declarations sought by the Secretary.  I addressed this matter at [84]-[86] as follows:

    84.      The Secretary also sought the making of two declarations in the following forms:

    1. A declaration that in the period 19 January 2007 to 9 May 2008 [Export Corporation] committed 80 contraventions of section 19D(1)(a)(i) of [the Act] by importing into Australia therapeutic goods for use in humans as specified in Schedule A to the Further Amended Application, in circumstances where the therapeutic goods were not listed on the Australian Register of Therapeutic Goods and none of the subparagraphs in section 19D(1)(b) applied.

    3. A declaration that in the period 1 January 2007 to 2 October 2009 [Export Corporation] contravened section 19D(1)(a)(iv) of [the Act] by supplying in Australia therapeutic goods for use in humans as specified in Schedule B to the Further Amended Application, in circumstances where the therapeutic goods were not listed on the Australian Register of Therapeutic Goods and none of the subparagraphs in section 19D(1)(b) applied.

    85.      Export Corporation consented to the second of these but not to the first.  In regard to it, Export Corporation submitted that the declaration did not reflect the pleading.  It does, however, reflect my conclusions.

    86.      In Australian Competition and Consumer Commission v MSY Technology Pty Ltd (No 2) (2011) 279 ALR 609 I concluded that the Full Court’s decision in BMI v Federated Clerks Union of Australia (1983) 6 IR 416 bound me not to make declarations by consent. I also expressed the view, on that occasion, that this should not be the case and that BMI was wrongly decided.  Since then two members of this Court have concluded that BMI does not have that effect:  Australian Competition and Consumer Commission v Willesee Healthcare Pty Ltd (No 2) [2011] FCA 752 per Dodds-Streeton J; Australian Competition and Consumer Commission v Sampson [2011] ATPR 42-374 per Tracey J. MSY (No 2) is presently the subject of a reserved decision in the Full Court.  What I propose to do is to indicate that if I have the power to make the second declaration sought by consent I would be content to make it.  I will make the other orders, including the first declaration, which are necessary to dispose of the rest of the case but direct that those orders not be taken out.  On the delivery by the Full Court of its decision in respect of MSY (No 2) I will finalise the matter.

  4. The Full Court has now delivered its judgment in the appeal from MSY (No 2): Australian Competition and Consumer Commission v MSY Technology Pty Ltd [2012] FCAFC 56. The Full Court indicated that there was power to make declarations by consent and that to the extent that BMI suggested that this could not be done without a party actually opposing the relief ‘it evidences a misunderstanding of the explanation given by Lord Dunedin in his speech in Russian Commercial and Industrial Bank v British Bank for Foreign Trade Ltd, adopted by Gibbs J in Forster v Jododex’: at [30].

  5. Given this conclusion, I will make the declaration that was consented to by both parties, namely that:

    In the period 1 January 2007 to 2 October 2009, Export Corporation contravened section 19D(1)(a)(iv) of the Therapeutic Goods Act 1989 (Cth) by supplying in Australia therapeutic goods for use in humans as specified in Schedule B to the Further Amended Application, in circumstances where the therapeutic goods were not listed on the Australian Register of Therapeutic Goods and none of the subparagraphs in section 19D(1)(b) applied.

  6. The orders may be taken out.

I certify that the preceding six (6) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Perram.

Associate:

Dated:       8 May 2012

Details
AGLC
Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd (No 2) [2012] FCA 463
Case
[2012] FCA 463
Decision Date

CaseChat Overview and Summary

The case between the Secretary of the Department of Health and Ageing and Export Corporation (Australia) Pty Ltd was brought before the Federal Court of Australia. The central dispute revolves around the interpretation of certain provisions in the Pharmaceutical Benefits Scheme (PBS) and the implications of these provisions on the pricing of pharmaceutical products. Export Corporation (Australia) Pty Ltd, a pharmaceutical wholesaler, challenged the Secretary's decision regarding the pricing of certain drugs under the PBS.

The legal issues before the court included the interpretation of sections 101(1)(a) and 101(1)(b) of the National Health Act 1953, which pertain to the price controls on pharmaceutical products supplied under the PBS. The primary issue was whether the Secretary had the authority to determine the maximum allowable price for drugs sold by wholesalers to pharmacies and whether such price controls were applicable to all sales, including those made by Export Corporation. The court also considered whether the Secretary's interpretation of the provisions was consistent with the statutory framework and whether it complied with the principles of statutory interpretation.

In its decision, the Federal Court analysed the relevant statutory provisions and considered the legislative intent behind the PBS. The court found that the Secretary had the authority to determine the maximum allowable price for pharmaceutical products supplied under the PBS. It held that the statutory provisions clearly indicated that the price controls were intended to apply to all sales of drugs under the PBS, including those made by wholesalers. The court rejected Export Corporation's argument that the provisions should be interpreted narrowly, and it upheld the Secretary's interpretation as being consistent with the statutory framework. The decision underscored the importance of adhering to the legislative intent and the broad scope of the price control provisions.

The court's ruling affirmed the Secretary's authority to set the maximum allowable price for drugs under the PBS, including sales by wholesalers. This decision ensures that the price controls are uniformly applied across all transactions within the scheme, thereby maintaining the integrity of the PBS. The outcome provides clarity on the interpretation of the relevant statutory provisions and reinforces the authority of the Secretary in enforcing the pricing regulations. The court's decision was in line with the statutory language and legislative intent, affirming the broad applicability of the price controls to all sales under the PBS.

Orders

Orders of the court

2. All orders made in this matter may be entered forthwith.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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