Pro Health Products Pty Limited v McEwen [2004] FCA 1790

FEDERAL COURT OF AUSTRALIA

Pro Health Products Pty Limited v McEwen [2004] FCA 1790 PRO HEALTH PRODUCTS PTY LIMITED v JOHN McEWEN IN HIS CAPACITY AS CHAIR OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE & ORS ACD 37 OF 2004 EMMETT J 11 OCTOBER 2004 SYDNEY (By video-link to Canberra)

IN THE FEDERAL COURT OF AUSTRALIA

AUSTRALIAN CAPITAL TERRITORY DISTRICT REGISTRY ACD 37 OF 2004

BETWEEN: PRO HEALTH PRODUCTS PTY LIMITED

APPLICANT

AND: JOHN MCEWEN IN HIS CAPACITY AS CHAIR OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE

FIRST RESPONDENT

MICHAEL O'CONNOR IN HIS CAPACITY AS THE SECRETARY OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE

SECOND RESPONDENT

THE COMMONWEALTH OF AUSTRALIA

THIRD RESPONDENT

JUDGE: EMMETT J

DATE OF ORDER: 11 OCTOBER 2004

WHERE MADE: SYDNEY (By video-link to Canberra)

THE COURT ORDERS THAT: 1. The application be dismissed. 2. The applicant pay the respondent's costs. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

AUSTRALIAN CAPITAL TERRITORY DISTRICT REGISTRY ACD 37 OF 2004

BETWEEN: PRO HEALTH PRODUCTS PTY LIMITED

APPLICANT

AND: JOHN MCEWEN IN HIS CAPACITY AS CHAIR OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE

FIRST RESPONDENT

MICHAEL O'CONNOR IN HIS CAPACITY AS THE SECRETARY OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE

SECOND RESPONDENT

THE COMMONWEALTH OF AUSTRALIA

THIRD RESPONDENT

JUDGE: EMMETT J

DATE: 11 OCTOBER 2004

PLACE: SYDNEY (By video-link to Canberra)

REASONS FOR JUDGMENT 1 The applicant, Pro-Health Products Pty Limited, ('Pro-Health'), distributes a product called 'NICOBREVIN Stop Smoking Support Course' ('NICOBREVIN') to pharmacists throughout Australia. It does so under a sole distributorship licence from the German owners of the product. Pro-Health also supplies the product directly to the public through its nationwide specialised smoking cessation consultancy. NICOBREVIN contains quinine and is sold over the counter. 2 Pro-Health has commenced this proceeding in relation to a proposed meeting of the National Drugs and Poisons Schedule Committee ('the Poisons Committee') to be held on 12 to 14 October 2004. Pro-Health claims that the Poisons Committee threatens to make a decision at that meeting the effect of which is that therapeutic products containing quinine can only be supplied on prescription. Pro-Health says that such a decision would be harmful to it and that it has been denied procedural fairness in relation to the proposal to consider that question at the meeting. 3 In the proceeding, which was commenced last Thursday, Pro-Health seeks relief under the Administrative Decisions (Judicial Review) Act 1977 (Cth), the Judiciary Act 1903 (Cth) and the Federal Court of Australia Act 1976. In essence, Pro-Health seeks a declaration that for the Poisons Committee to proceed with the proposed decision at its meeting of 12 to 14 October 2004 would be a breach of a duty to afford Pro-Health natural justice to the extent of affording it a reasonable opportunity to make submissions. There is no issue concerning the standing of Pro-Health to claim the relief sought in the proceeding, nor is there any issue as to the jurisdiction of the Court to grant relief in respect of the proposed decision. 4 It is desirable to say something about the Poisons Committee and its constitution and function under the Therapeutic Goods Act 1989 (Cth). The objects of the Therapeutic Goods Act include: '…provid[ing] for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods.' More specifically: '…provid[ing] a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia.' 5 In furtherance of that second object, the Therapeutic Goods Act contains Part 6-3, which is entitled 'National Drugs and Poisons Schedule Committee'. The Poisons Committee was established under s 52B. Under s 52B(3) the Commonwealth, each State, the Northern Territory and the Australian Capital Territory are each entitled to nominate a representative on the Poisons Committee. Section 52C provides that the functions of the Poisons Committee include making decisions in relation to the classification and scheduling of substances and maintaining the 'current Poisons Standard'. 6 The 'current Poisons Standard' is defined in s 52A as being: * the first Poisons Standard, being the latest edition, at the commencement of Part 6-3 of the Act, of the document known as the 'Standard for the Uniform Scheduling of Drugs and Poisons', published by the Australian Health Ministers' Advisory Council, or * if a document, being a new Poisons Standard, is prepared by the Poisons Committee pursuant to s 52D, that new Poisons Standard. 7 Under s 52D(1), on the commencement of Part 6-3, the first Poisons Standard is taken to have been prepared and made available by the Poisons Committee. Under s 52D(2), the Poisons Committee has power to amend the current Poisons Standard. However, under s 52D(4), as soon as practicable after an amendment is made to the current Poisons Standard, the Poisons Committee must cause a notice to be published in the Government Gazette stating inter alia that an amendment has been made and the date on which the amendment comes into effect. Under s 52E(1), in exercising the powers conferred by s 52D(2), the Poisons Committee must take into account a number of matters, including the toxicity and safety of a substance and the risks and benefits associated with the use of a substance. 8 The Therapeutic Goods Regulations 1990 have been made under the Therapeutic Goods Act. Division 3A of the Regulations deals with the Poisons Committee. Under Regulation 42ZCD, the Poisons Committee is to comprise each of the representatives nominated under s 52B(3) of the Act, the persons appointed under Regulation 42ZCD(4)(c) or (d) and other persons appointed by the Minister. The representatives appointed under par 42ZCD(4)(c) and (d) are to be experts in particular fields and representatives of other bodies. Subdivision 4 of Division 3A deals with procedures of the Poisons Committee. 9 Regulation 42ZCM provides that for s 52B(2), subdivision 4 sets out the procedures that the Poisons Committee must follow in holding meetings. Section 42ZCN provides that in performing its functions: '…the Committee: