When may the Committee make a recommendation?
21 The applicant submits that, under the Act, the Committee is empowered to consider applications to the effect that it recommend to the Minister that a drug be made available as a pharmaceutical benefit, or to make such a recommendation of its own motion. The Committee may also, at the request of the Minister, provide advice on other matters within its competence. The applicant contends that the Committee's power is correctly characterised as one to make recommendations upon which certain exercises of the Minister's statutory power are predicated. If the Committee decides not to make a recommendation in respect of a drug, then the Minister cannot make a declaration under s 85(2A), given the presence of par (b) in that subsection. This much is unexceptionable and accords with what the Full Court held in Pfizer.
22 The applicant submits that what has happened in the instant case is that the Committee has purported to recommend changes to a recommendation which it has already made and which the Minister has already accepted. It is further submitted that at the time when the Committee decides to make a recommendation to the Minister, it can qualify that recommendation to specify that it is of the opinion that a drug should be made available only in specified circumstances, but it may not later qualify its recommendation. In the applicant's submission, it is only at the time when an initial recommendation is made that the Committee can exercise its power under s 101(3C). In the words of Counsel for the applicant, it is "not a free-standing power". On this view, once made, a recommendation is beyond the Committee's power of recall and it may not revisit the issue of the circumstances for prescription of a drug which it has already recommended to the Minister be declared available as a pharmaceutical benefit. This argument turns entirely on a construction of the Committee's power under s 101(3). The construction for which the applicant contends derives some support from the presence in s 101(3C) of the words "…the Committee shall, in its recommendation under subsection (3), specify those circumstances" (emphasis added).
23 The critical words in s 101(3) are "The Pharmaceutical Benefits Advisory Committee shall make recommendations to the Minister from time to time as to the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits under this Part …..". As the Full Court observed in Pfizer at p 314:
'[33] Section 101(3) in terms imposes a duty on the PBAC to make recommendations to the Minister "as to the drugs and medical preparations which it considers should be made available as pharmaceutical benefits under [Pt VII]".
[34] The duty imposed on the PBAC by s 101(3) to make recommendations to the Minister is a duty to be performed "from time to time". It is appropriate to construe s 101(3) in the light of s 33(1) of the Acts Interpretation Act 1901 (Cth) which relevantly provides that where an Act imposes a duty, then, unless the contrary intention appears, the duty shall be performed "from time to time as occasion requires" (emphasis added). When a person calls on the PBAC to perform the duty imposed on it by s 101(3), the PBAC is obliged to consider whether the occasion requires the performance of the duty. However, the PBAC is, of course, not obliged to perform the duty unless it concludes that the occasion does require its performance. An analogy may be found in the approach to the construction of the power to grant an approval for exportation of goods taken by Mason J in Murphyores Incorporated Pty Ltd v Commonwealth (1976) 136 CLR 1 at 17-18. See also Hicks v Aboriginal Legal Service of Western Australia (Inc) (FC) [2001] FCA 483 at [11].'
24 Quite simply, the only element of s 101(3c) which might require that the Committee's powers are to be exercised only once and for all in respect of a particular drug or medicinal preparation is the stipulation that the specification of the circumstances in which the Committee considers the drug should be made available as a pharmaceutical benefit is to be in its recommendation under s 101(3). The applicant's construction derives no support from the fact that, on its face, the duty imposed is to act "from time to time", as occasion requires, although the words "from time to time" are not of themselves inconsistent with the conferral of a power which can only be exercised once in respect of a given subject matter. The Full Court considered the words expressing the Committee's duty and power under s 101(3) to be words of wide scope (Pfizer at pp.314-315, [36]), an observation which I regard as equally applicable, prima facie, to when the Committee may make its recommendations, including recommendations as to circumstances pursuant to the subsidiary power conferred by s 101(3C).
25 The applicant submits, however, that to allow the Committee to vary its recommendations could conceivably allow circumvention of the parliamentary scrutiny which is required before a cessation declaration can take effect. On this argument, if a drug were initially made available under Part VII with few conditions imposed, access to it could then later be significantly reduced by the imposition of conditions. Indeed, a set of preconditions for the prescription of a drug could be imposed that was so onerous that the likelihood of its being prescribed would be reduced virtually to nil - even if that drug had been initially available for prescription without relevant restrictions or preconditions. This, it is contended, could effectively result in a cessation declaration being made without the instrument of cessation having been laid before Parliament as a disallowable instrument. This consideration is said to entail that the Act, on its proper construction, does not permit any variation to a Committee recommendation or to a subsidiary Ministerial declaration under s 85(2A) once made. Indeed, Counsel for the applicant went so far in response to a question in the course of argument, to contend that there is no mechanism at all for the Minister to change the declared circumstances in which a drug may be prescribed without first determining under s 85(2AA) that the drug should cease to be one to which Part VII applies. Only by the Minister making a cessation declaration under s 85(2AA), followed by a completely new declaration predicated upon a new recommendation from the Committee, could new or additional conditions or restrictions be attached to a drug which had been the subject of an earlier declaration specifying different circumstances in which a prescription for it might be written. This construction likens the legislation to a sequence of one-way doors or gates, with the effect that, once through one door, one must proceed to the end and only then, if necessary, begin again. It is true that the Act ordains that certain irrevocable consequences follow from the taking of particular steps. Clearly, the declaration by the Minister of a drug for the purposes of Part VII of the Act can only be reversed by a disallowance of an instrument which has been laid before Parliament or a "cessation declaration" under s 85(2AA). However, that does not entail that a declaration once made with or without a specification of the circumstances in which it can be prescribed, remains immutable in all respects until it ceases to have effect pursuant to s 85(2AA).
26 There are several reasons why I have not been persuaded to adopt the construction for which the applicant contended. In the first place, it would achieve a curious effect if s 101(3), viewing it for the moment in isolation from the rest of the Act, were construed as conferring a power exercisable only once in respect of a given drug for medicinal preparation. The Committee's power is purely recommendatory even though its exercise may lead to the Minister's making a declaration under s 85(2) and, if appropriate, a subsidiary declaration under s 85(2A). Moreover, the Committee is under a duty to exercise the power from time to time as the occasion arises.
27 The strongest argument for subjecting the Committee to the restriction for which the applicant contends is founded on the premise that the Minister's power to make declarations is similarly restricted. If the Minister cannot vary a declaration in relation to a particular drug once made, there would be no point in the Committee's having a facility to recommend variations to an existing declaration. However, for the reasons explained at [24] above, I am not persuaded that the Act links the power of the Minister so closely to the extant declaration in respect of a given drug. The only indication in the relevant sections that the Minister's power to make declarations of the circumstances in which a prescription for a declared pharmaceutical benefit might be written is exercisable once and for all is the presence in the prefatory words of s 85(2A) of the phrase "in a declaration under subsection (2)." That phrase mirrors the expression "in its recommendation under subsection (3)" in s 101(3C) to which I have added emphasis at [22] above. The suggestion that the Minister's power to specify circumstances in which a prescription for the supply of a declared drug can be written must be exercised, if at all, contemporaneously with the making of the original declaration is counteracted by other indications in the language, arrangement and subject-matter of relevant provisions in Part VII of the Act. It is contemplated that the provision of pharmaceutical benefits will continue indefinitely into the future; they shall be provided by the Commonwealth in respect of drugs in relation to which Part VII applies [s 85(1)]; and the Committee's duty is to make recommendations from time to time as to the drugs which it considers "should be made available" as pharmaceutical benefits under Part VII [s 101(3)]. As well, drugs and medicinal preparations with which the legislation is concerned are notoriously subject to continuing evaluation and review in the light of new discoveries and further research, clinical experience or observation. Indeed, s 102 of the Act expressly empowers the Secretary to the Health Department to make such arrangements as he or she considers necessary for the testing or analysis of pharmaceutical benefits or of drugs which may be used as pharmaceutical benefits. If the legislature intended that effect could only be given to a review or fresh assessment of that kind by a declaration of cessation under s 85(2AA), it entrusted the Minister and the Committee with an excessively blunt instrument for shaping pharmaceutical benefits in the public interest which Part VII is manifestly concerned to advance. I would only be prepared to impute such an intention to Parliament if the language of the legislation intractably compelled that course.
28 I also consider that s 33(3) of the Acts Interpretation Act 1901 (Cth) ("the Interpretation Act") is applicable to the Minister's power to make declarations under s 85(2) and s 85(2A) of the Act. Subsection 33(3) of the Interpretation Act provides that;
'Where an Act confers a power to make, grant or issue any instrument (including rules, regulations or by-laws) the power shall, unless the contrary intention appears, be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.'
That statutory provision raises the issue of whether Ministerial declarations are capable of amendment or variation. A declaration under s 85(2) of the Act, including one that contains the subsidiary declarations contemplated by s 85(2A) is, I consider, an "instrument" which the Minister is empowered to make or issue within the meaning of s 33(3) of the Interpretation Act; see R v Ng [2002] VSCA 108 (2 August 2002) where the Victorian Court of Appeal held that a search warrant issued by a Judge of this Court was an "instrument" for the purposes of s 46(1) of the Interpretation Act. Prima facie, therefore, the power to make or issue a declaration under s 85(2) of the Act, with or without specifying circumstances in which a prescription for the supply of the drug may be written, includes a power to revoke, amend or vary a declaration so made. I do not regard the express grant of power by s 85(2AA) to declare that a drug shall cease to be one to which Part VII applies as evincing a contrary intention within the meaning of s 33(3) of the Interpretation Act. All that s 85(2AA) does is make express the power of revocation implied by s 33(3) of the Interpretation Act, while s 85(2AB) imposes the additional requirement that the Minister, before making a cessation declaration, shall obtain the advice in writing of the Committee in relation to the proposed declaration. By force of s 85(2B) both declarations under s 85(2) and cessation declarations under s 85(2AA) are disallowable instruments which have to be laid before both Houses of Parliament with the superadded requirement that cessation declarations have to be accompanied by the written advice of the Committee. By contrast, a declaration under s 85(2) may be made by the Minister with the support of a bare recommendation by the Committee; s 101(4)(b). On this analysis, the relevant provisions of s 85, although attaching a condition to the power to revoke or rescind a declaration made under s 85(2), do not take away that power and are completely silent as to the power to amend or vary implied by s 33(3) of the Interpretation Act.
29 The applicant's argument that a power to recommend different circumstances in which a prescription for a drug already declared to be a pharmaceutical benefit can be exercised so as to circumvent the need to lay a "cessation declaration" before both Houses of Parliament can be answered in two ways. In the first place, the power to make recommendations conferred on the Committee and that conferred on the Minister to make declarations under s 85(2)(a) are both subject to the implied limitation that they are to be exercised only for the purposes for which they are conferred; see eg The Queen v Toohey; Ex parte Northern Land Council (1981) 151 CLR 170 per Gibbs CJ at 186. Secondly, it is clear from the terms of s 85(2B) that the obligation to lay it before Parliament attaches no less to a declaration under s 85(2)(a) (including, on the construction I prefer, a declaration varying an original declaration under that paragraph) than to a "cessation declaration" under s 85(2AA).
30 It follows from the view which I take of the legislation that the Minister has the power to vary both a general declaration under s 85(2)(a) of a drug as one to which Part VII applies and a subsidiary declaration under s 85(2A) specifying the circumstances in which a prescription for the supply of a declared drug may be written. Such a power entails, in the absence of express statutory exclusion, a corresponding power in the Committee to recommend the variation. That is because, in respect of drugs which became pharmaceutical benefits after the commencement of s 101(4), that subsection makes the Committee's recommendation a condition precedent to the making of a declaration under s 85(2)(a) including a declaration by way of variation of a first or original declaration.
31 Issues of practicality, as well as the language of the Act, also favour the Committee being able to furnish recommendations and advice within the area of its expertise on its own motion after an initial recommendation has been made. I have already referred at [27] of these reasons to the likelihood that new developments or further research or clinical experience will warrant the Committee from time to time making a fresh or revised recommendation in respect of a drug already declared and made available as a pharmaceutical benefit. Support for the view that the Act contemplates the discharge of that duty is provided by the fact that the duty imposed on the Committee by s 101(3) is to make recommendations "from time to time as to the drugs ….. which it considers should be made available as pharmaceutical benefits ….." (emphasis added). That form of words imports a power that is wider than one simply to recommend "the drugs which should be made available". It embraces, in my view, a power to recommend that a presently declared drug no longer be made available as a pharmaceutical benefit or that the specified circumstances in which a prescription for the supply of a presently declared drug may be written should be varied.