Pro Health Products Pty Limited v McEwen
[2004] FCA 1790
•11 OCTOBER 2004
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
APPLICANTAND:
JOHN MCEWEN IN HIS CAPACITY AS CHAIR OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE
FIRST RESPONDENTMICHAEL O’CONNOR IN HIS CAPACITY AS THE SECRETARY OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE
SECOND RESPONDENTTHE COMMONWEALTH OF AUSTRALIA
THIRD RESPONDENTJUDGE:
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
APPLICANTAND:
JOHN MCEWEN IN HIS CAPACITY AS CHAIR OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE
FIRST RESPONDENTMICHAEL O’CONNOR IN HIS CAPACITY AS THE SECRETARY OF THE NATIONAL DRUGS AND POISONS SCHEDULING COMMITTEE
SECOND RESPONDENTTHE COMMONWEALTH OF AUSTRALIA
THIRD RESPONDENTJUDGE:
EMMETT J
DATE:
11 OCTOBER 2004
PLACE:
SYDNEY (By video-link to Canberra)
REASONS FOR JUDGMENT
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.
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.
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.
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.’
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’.
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.
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.
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.
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:
(a)must act according to these Regulations; and
(b)must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c)is not bound by rules of evidence; and
(d)may obtain information about an issue in any way it considers appropriate.’
Subdivision 5 of Division 3A deals with scheduling procedures. Regulation 42ZCT defines a ‘scheduling meeting’ as a meeting of the Poisons Committee for the scheduling of a substance. Under s 52A of the Therapeutic Goods Act:
‘scheduling, in relation to a substance, means determining the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included.’
Section 42ZCU(1) provides that:
‘Before a scheduling meeting, the Chair of the [Poisons] Committee must publish a notice in the Gazette:
(a)mentioning the date of the proposed scheduling meeting; and
(b)mentioning each substance to be considered for scheduling at the meeting; and
(c)inviting public submissions to be made by a date mentioned in the notice as the closing date for public submissions...’
Under Regulation 42CZU(2):
‘The closing date must be at least 4 weeks after the publication of the Gazette notice.
Under Regulation 42CZU(3):
‘The date of the meeting must be at least a week after the closing date.’
Regulation 42ZCV provides that:
‘(1)The [Poisons] Committee, in making a decision in relation to the classification and scheduling of a substance, must consider all public submissions made by the closing date that address a matter mentioned in section 52E of the Act.
(2)The [Poisons] Committee need not consider a public submission made after the closing date.’
Regulation 42CZW provides that:
‘(1)A submission prepared in relation to a substance by a Committee member about the scheduling of a substance must be considered by the Committee.
(2)The [Poisons] Committee must also take into account any recommendation of a subcommittee about the substance.’
Regulation 42ZCY deals specifically with the requirement under s 52D(4) for public notice of a proposed amendment to the current Poisons Standard. Under Regulation 42ZCY(1):
‘A notice under subsection 52D(4) of the Act must include:
(a) an indication of the amendment; and
(b)instruction on how the record of the reasons for the amendment may be accessed; and
(c)an invitation to persons who made a public submission in relation to the substance the subject of the amendment to make a further submission.’
Regulation 42ZCZ(1) then provides that:
‘A submission in response to an invitation mentioned in paragraph 42ZCY(1)(c) must be made within 2 weeks after publication of the notice making the invitation.’
Regulation 42ZCZ(3) then requires that:
‘If a submission is made to the [Poisons] Committee under this regulation, the [Poisons] Committee must consider the submission and then:
(a) confirm the amendment; or
(b) vary the amendment; or
(c) set aside the amendment…’
Thus, the regime contemplated in relation to amendment to the current Poisons Standard involves the possibility of two meetings of the Poisons Committee. The first is the meeting to consider an amendment, notice of which must be given inviting submissions. The second is a meeting to consider any subsequent submissions, if a decision is made to make an amendment to the current Poisons Standard. In relation to the second meeting, it is only those persons who had made submissions to the first meeting who are to be invited to make further submissions.
On 18 August 2004 the Chair of the Poisons Committee published a notice in the Gazette that the next scheduling meeting of the Poisons Committee was to be held on 12 to 14 October 2004. The notice relevantly provided as follows:
‘Substances to be considered for scheduling by the [Poisons Committee] are open for public comment.
Accordingly, public submissions are invited on those substances mentioned below which are to be considered for scheduling at the October 2004 meeting. Public submissions must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989...
…
The closing date for submissions is 15 September 2004.The [Poisons Committee], in making a decision in relation to the classification and scheduling of a substance, must consider all public submissions made by the closing date that address a matter mentioned in section 52E of the Act. Public submissions that reserve the right to comment on a scheduling proposal or are made after the closing date need not be considered by the [Poisons Committee].
The post‑October 2004 meeting notice will invite further public submissions on substances that are the subject of an amendment to the Schedules at the October 2004 meeting. Regulation 42ZCY of the Therapeutic Goods Regulations 1990, however, restricts this invitation to those persons who made a valid public submission in relation to the substance in response to this pre‑meeting notice.’
The notice then includes a schedule of substances to be considered for scheduling. Relevantly for present purposes, item 6 headed ‘Other Pharmaceuticals’, contains the following item:
‘6.6 Quinine - consideration of scheduling including the deletion of the exemption clause from the Schedule 4 entry.’
That matter is of significance to Pro-Health because, as I have said, NICOBREVIN contains small quantities of quinine.
The possible amendment to Schedule 4 needs to be explained. Schedule 4 of the current Poisons Standard presently refers to quinine in the following terms:
‘Quinine for human internal use except:
(a) when included in Schedule 3; or
(b)in preparations containing 50 mg or less of quinine per recommended daily dose.’
The effect of including a substance in Schedule 4 is that it may not be sold over the counter and can only be sold on prescription by a medical practitioner. The current reference to quinine is of no concern to Pro-Health because NICOBREVIN contains less than 50 mg of quinine per recommended daily dose. The reference to deletion of the exemption clause is a reference to the exception contained in the reference to quinine in Schedule 4 as it presently stands.
The genesis for the proposal to amend the reference to quinine in Schedule 4 of the Poisons Standard appears to be a resolution of the Australian Drug Evaluation Committee (‘ADEC’) held on 2 to 4 October 2003, made in response to a recommendation by the Adverse Drug Reactions Advisory Committee (‘ADRAC’), a subcommittee of ADEC. By that resolution, ADEC resolved to make a recommendation to the Minister and the Secretary, I assume of the Department of Health, in the following terms:
‘In the matter relating to ‘Quinine and Thrombocytopenia’, ADRAC recommended that ADEC consider the removal of all indications for quinine containing products except for the treatment of malaria. In response the ADEC resolved to recommend that-:
· All Sponsors of quinine containing products should be requested by the [Therapeutic Goods Administration] to provide data to justify all non malarious indications;
· The [Therapeutic Goods Administration] should undertake a review of the current poisons schedules of these products and take any appropriate regulatory action.’
It is the second recommendation that seems to have given rise, ultimately, to the proposal foreshadowed in the notice of 18 August 2004. The first recommendation involved Pro-Health. Apparently, in pursuance of that recommendation, the head of the Over the Counter (‘OTC’) Medicines Section of the Therapeutic Goods Administration (‘TGA’) wrote to Pro-Health on 4 January 2004. Copies of the relevant ADEC and ADRAC minutes were attached to the letter. In that letter, the head of the section relevantly said:
‘The Australian Register of Therapeutic Goods (ARTG) indicates that you are the sponsor of NICOBREVIN...
The Australian Drug Evaluation Committee recommended at its meeting on 2-4 October 2003 that “all sponsors of quinine containing products should be requested by the TGA to provide data to justify all non malarious indications.”…
You are requested to provide data to justify the safety of NICOBREVIN in terms of the potential for quinine to cause severe haematological adverse reactions (e.g. thrombocytopenia). These data are requested under the provisions of Section 31 of the Therapeutic Goods Act 1989 and should be provided to the undersigned by 5 pm on 30 January 2004.’
Thus Pro-Health had knowledge by early 2004 of the possibility that products containing quinine were under consideration by the authorities in relation to the possibility of their being a cause of thrombocytopenia.
Pro-Health responded to the letter of 4 January 2004 on 28 January 2004 and then again on 5 February 2004. In the letter of 28 January 2004 Pro-Health relevantly said:
‘The ADRAC data clearly shows that thrombocytopenia generally occurs at the standard doses of quinine for nocturnal cramp or malaria, ie. 300-600 mg, although the vast majority of patients affected appeared to have recovered without sequelae. I understand that the submission to the [Poisons Committee] included evidence that, whilst the results of clinical studies vary, they set the no-untoward-effect level at the range 52.5 mg/day through 80 mg/day to 120 mg/day. The post‑marketing experience over 35 years of Nicobrevin, reveals a very low incidence (0.00018%) of spontaneously reported events.
…The indications for Nicobrevin are for the treatment of a chronic, serious, life threatening condition, i.e. tobacco smoking/nicotine addiction but without the hazard of utilising nicotine replacement or bupropion hydrochloride (Zyban) as its mode of action.
…I trust that, having regard to the above, in the interests of improving the health of Australian smokers by helping them to quit and, in so doing, relieving the National Exchequer of the financial burden and the country generally of the economic burden of smoking‑related illnesses, you will agree that Nicobrevin should retain its general sale status to ensure that it remains readily accessible to the many hundreds of thousands, if not millions, of Australian smokers who desperately need its support to quit smoking.’
That letter was followed up by the letter of 5 February 2004, in which Pro-Health indicated that it had obtained some statistics from the Health Insurance Commission concerning the total number of prescriptions issued for 300 mg tablets of quinine sulphate and quinine bisulphate between December 1996 and November 2003. The letter attached some statistics and relevantly said:
‘Expressed as a percentage of the total number of high-dose quinine prescriptions issued over the 8-year period from December 1996 to November 2003, the 73 adverse reactions reported amount to only 0.0167% or less than two thousandths of one per cent.
……if the scourge of smoking‑related diseases, the financial and physical burden they impose on the National Health service, the economic burden they impose on trade and industry through absenteeism and consequent loss of production, and the physical misery and financial hardship they impose on the victims and their dependents are to be eradicated in Australia, it follows that, as the safest and most effective smoking cessation support product on the market, Nicobrevin should be fully supported by the TGA and, having proven the safety of its low-dose quinine content, its General Sale status should be preserved to make it readily accessible to the smoking public for the benefit [of] all concerned.’
It is against the background of that exchange that on 9 September 2004 Pro-Health received from the executive secretary of the Medicines Evaluation Committee a letter dated 2 September 2004 dealing with the proposed amendment of the current Poisons Standard. The letter relevantly said as follows:
‘The [Poisons Committee] is currently reviewing the scheduling of quinine. The [Poisons Committee] recommended deletion of the SUSDP Schedule 3 entry for quinine in February 2004 (effective date: 1 September 2004) and proposed to consider the scheduling further following receipt of advice concerning unscheduled preparations containing quinine from the Medicines Evaluation Committee (MEC).
The TGA’s OTC Medicines Section wrote to you in January 2004, requesting you to provide data justifying the safety of Nicobrevin, in terms of the potential for quinine to cause severe haematological reactions (eg. thrombocytopenia). The MEC considered your response and other relevant information at its meeting on 3 June 2004. The MEC recommended that all quinine-containing products should be included in Schedule 4 to the SUSDP, as quinine is not suitable for use except on medical advice due to its unfavourable risk/benefit ratio. The [Poisons Committee] has been informed of the MEC’s advice. An extract of the ratified minutes of the MEC meeting of 3 June 2004 is attached.’
Attached to the letter was a 4 page document headed ‘Extract of Minutes Medicines Evaluation Committee Meeting - 3 June 2004’. It contained item 9.3, headed ‘Safety of quinine in OTC Products’. The extract relevantly said:
‘The [Poisons Committee] had requested comment from the MEC on a review of the scheduling of quinine, following concerns raised by the ADEC and ADRAC over reports of severe thrombocytopenia associated with the use of quinine for nocturnal cramps. The [Poisons Committee] had sought comment from the MEC (and CMEC) on the proposed scheduling review prior to the February 2004 [Poisons Committee] meeting.
The MEC had noted, at its February 2004 meeting, that there are no Schedule 3 products containing quinine on the ARTG and only one registered OTC medicine containing quinine – Nicobrevin... Nicobrevin which is currently unscheduled, contains quinine 15 mg per capsule with a maximum daily dosage of 45 mg... There are also several listed homoeopathic medicines containing quinine at very low concentrations. The MEC and [Poisons Committee] were advised in February 2004 that the TGA had written to [Pro-Health], the sponsor of Nicobrevin, citing concerns about an apparent link between products containing quinine and thrombocytopenia.
The committee was advised that, following a review of data on Schedule 4 products containing quinine, the DSEB [Drug Safety and Evaluation Branch of the TGA] had agreed that use of those products was not justified on the basis of quinine’s unfavourable risk/benefit profile, other than for malaria. The DSEB had subsequently deleted all indications relating to muscle cramps/nocturnal leg cramps from Schedule 4 products containing quinine, in January 2004.
…The TGA had requested [Pro-Health] to provide data to justify Nicobrevin’s safety, in terms of the potential for quinine to cause severe haematological adverse reactions (such as thrombocytopenia). The sponsor's response was based on the following points:
·The amount of quinine ingested with Nicobrevin is similar to that from tonic water;
·The cases of thrombocytopenia reported to ADRAC involved higher doses of quinine (200-600 mg); and
·There have been few reports, worldwide, of adverse effects from use of Nicobrevin.’
The minutes then refer to a review of the safety of quinine in OTC products prepared for the TGA having been provided to the committee. The minutes then contained a summary of what was described as the ‘TGA Review - Safety of Quinine in OTC Products’. It contained five sub‑headings as follows:
(1) General toxicity of quinine
(2) Quinine and thrombocytopenia
(3) Post-marketing data on Nicobrevin
(4) The ‘Jessamine submission’
(5) Risk/benefit with Nicobrevin.
At the end of the extract from the minutes under the heading ‘Discussion’ the following appears:
‘Members noted that the data suggest a very small risk of thrombocytopenia with quinine in doses of less than 200 mg. However, although the sponsor had suggested a dose-threshold for quinine-induced thrombocytopenia, no specific evidence of such a dose-threshold had been provided or found. A member noted that while thrombocytopenia occurs infrequently with quinine, it can be fatal. In addition, significant morbidity is associated with quinine-induced thrombocytopenia. In these circumstances, a satisfactory risk/benefit ratio would depend on good evidence of efficacy. Given the doubtful evidence for Nicobrevin’s efficacy, the risk/benefit profile of this product was considered to be unfavourable.
The committee, noting that satisfactory evidence had not been provided to establish that the quinine in Nicobrevin provides or contributes to Nicobrevin’s putative efficacy in alleviating withdrawal symptoms experienced when giving up smoking, agreed that Nicobrevin should be removed from the ARTG on the basis of its unfavourable risk/benefit ratio.
The committee also agreed to recommend to the [Poisons Committee] that all quinine-containing products should be included in Schedule 4 to the SUSDP because quinine is not suitable for use without the advice of a medical practitioner due to its unfavourable risk/benefit ratio.
The committee noted that the SUSDP does not apply to foods and that the TGA does not regulate foods.’
Pro-Health through its solicitors wrote to the TGA on 14 September 2004, referring to the proposed meeting of 12 to 14 October 2004. The letter relevantly says:
‘Our client has previously made submissions to the [TGA], the [Poisons Committee] and the [MEC] concerning the scheduling of Quinine and the registration of Nicobrevin. As a consequence of those submissions, an exception to the listing of Quinine in Schedule 4 in preparations containing 50 mg or less of Quinine per recommended daily dose was granted and Nicobrevin was consequently registered on the Australian Register of Therapeutic Goods. This outcome arose through conciliation before the Administrative Appeals Tribunal.
If the current recommendation of [MEC] is accepted by the [Poisons Committee], it will result in the product, Nicobrevin being limited to prescription only medicine whereas at present, it is available by way of general sale. This change will significantly affect our client’s rights with respect to the product.
As such, we seek on behalf of [Pro-Health] to make submissions to the [Poisons Committee] concerning the proposed recommendation.
We note that the date for submissions expires at the close of business on 15 September, 2004.
Our client has only recently become aware of the proposal. Our client is keen to ensure that all relevant materials are before the [Poisons Committee] prior to any decision being made by that Committee. To this end, we seek an extension of time in which to lodge a submission on behalf of our client. Nicobrevin is the only registered [OTC] medicine containing Quinine. Therefore, our client is in a position of being particularly affected by the proposed decision.
Before we can make any meaningful submission on behalf of our client, we require access to the recent review of the safety of Quinine prepared for the TGA (by an unknown evaluator/author) as referred to in the [MEC] minutes of 3/6/04.
…
Insofar as we have not been provided access to this new report and will require time to consider its contents once it is received, it seems most unlikely that the meeting of 12-14 October of the [Poisons Committee] is an attainable date for our client. Accordingly, we ask that consideration of the rescheduling of Quinine be deferred to a meeting of a later date, preferably, to a date which reasonably suits our client's purposes in this regard.
Please provide us with a copy of the recent Quinine review as a matter of urgency.’
The secretary of the Poisons Committee responded to that letter on 15 September 2004, relevantly saying:
‘It is noted that you wish to make an additional submission in relation to quinine. The Committee would not object to you submitting supporting material relating to the gazetted quinine scheduling proposal before its next meeting on 12-14 October 2004.
Please note that should the October 2004 Committee meeting agree to make a scheduling amendment in relation to quinine, Regulation 42ZCY provides you with an opportunity to make a further public submission on the matter to the Committee. In the event that a scheduling amendment in relation to quinine is made and further public submissions are received by the specified closing date, they would be considered by the Committee at its next meeting to be held on 22-24 February 2005. The February 2005 Committee meeting would be required to either confirm, vary or set aside the quinine scheduling amendment. Should the quinine scheduling amendment be confirmed or varied it will come into effect through relevant State and Territory legislation on 1 May 2005.’
It is fair to say that that letter could be fairly construed as granting an extension of time to make a submission, that is to say, it states that the Poisons Committee will not object to Pro-Health submitting supporting material before its next meeting. On 21 September 2004, Pro-Health’s solicitors communicated again with the TGA, referring to their facsimile of 14 September and the response of 15 September, from the secretary of the Poisons Committee. The letter said:
‘We have now received a response to our facsimile from Mr O'Connor, Secretary of the [Poisons Committee], however, we do not appear to have received a response from you.
Specifically, we require your advice as to whether or not you are prepared to grant us access to the recent review of the safety of Quinine prepared for the TGA (by an unknown evaluator/author) as referred to in the [MEC] Minutes of 3/6/04, as requested in our facsimile dated 14 September, 2004.’
The solicitors wrote again on 23 September 2004 by facsimile, referring to the communication of 15 September 2004 and relevantly saying:
‘As our client is still waiting on the material requested from the [MEC], namely, the recent review of the safety of Quinine prepared for the TGA as referred to in the MEC Minutes of 3 June, 2004… we are unable to make any meaningful submission to the [Poisons Committee] prior to 12 October, 2004.
In the circumstances, we consider that by proceeding with the meeting on 12 October, 2004 as foreshadowed by you, the Department is denying our client natural justice in that it does not have the opportunity to make a submission to be considered before the Committee makes a scheduling amendment recommendation which will affect its rights, irrespective of the right to subsequent review of the recommendation.’
The letter then threatened to commence proceedings in the Federal Court. Apparently by way of response to that communication, there was sent, by facsimile, a copy of a document entitled ‘Safety of Quinine in OTC Products’. The document (‘the Report’) consisted of a cover page summarising attachments and eight further pages of commentary and references together with a ninth page setting out the formulation of NICOBREVIN. It is apparent that the minutes of the meeting of the MEC of 3 June 2004, which were enclosed with the letter to Pro-Health of 2 September 2004, were derived from the Report. The Report has a number of headings as follows:
- Background;
- General toxicity of quinine;
- Quinine and thrombocytopenia;
- Post-marketing data on Nicobrevin;
- The ‘Jessamine submission’;
- Risk benefit with Nicobrevin;
- Summary/conclusions.
While the minutes do not set out the detail contained in the Report, it is not suggested on behalf of Pro-Health that the minutes do not contain the substance of the material contained in the Report.
The copy of the Report that was sent by facsimile on 23 September 2004 was unsatisfactory in that two sections of it, which were shaded in the original, were quite illegible in the copy of 23 September 2004. Accordingly, on 24 September 2004, Pro-Health’s solicitors sent another facsimile to the TGA pointing out that there were parts of the Report that had been blanked out and other parts that had been shaded. The facsimile asked for the name and author of the Report and the curriculum vitae of the author. It also requested particulars of the shaded material that was illegible. On 3 October 2004, a legible copy of the whole of the Report was received by Pro-Health, although the name of the author was also redacted on that version.
It is not suggested that the shaded material of the Report was of any significance. I shall describe it. Before the heading ‘Background’, the following material was shaded:
‘Issues
1.There are no specific reports of thrombocytopenia after administration of Nicobrevin or quinine at similar doses to that provided by Nicobrevin.
2.There is no theoretical reason why Nicobrevin could not induce thrombocytopenia, since the effect does not appear to be dose-related.’
At the end of the Report, under the heading ‘Summary/conclusions’ and before the references, the following material had been shaded:
‘The MEC is requested to consider whether the costs of placing Nicobrevin in Schedule 4 (a consequence of the [Poisons Committee’s] initial proposed schedule changes for quinine) is justified by the theoretical, but unconfirmed risk of thrombocytopenia from low dose quinine, including Nicobrevin.’
The thrust of the complaint made by Pro-Health is that it was not until 3 October 2004 that Pro-Health knew for certain that there was nothing in the Report that had not been disclosed to it by the minutes of the meeting of the MEC enclosed with the letter of 2 September 2004. Pro-Health also complains that, because it does not know the identity or qualifications of the author of the Report, it is unable to respond appropriately to it. Finally, the assertion was made from the bar table, although it was unsupported by evidence, that even if that information had been furnished by 9 September 2004, there would have been inadequate time for Pro-Health to consult an appropriately qualified expert to respond.
Certainly, this matter has been brought on with considerable urgency. Nevertheless, it is incumbent upon an applicant to make out its case by adducing appropriate evidence. I take it to be, therefore, that the thrust of the complaint is in relation to the first two matters, namely that it was not until 3 October 2004 that the two shaded parts were disclosed and, even now, there has been no formal notification to Pro-Health of the identity and qualifications of the author of the Report. However, as I have said, it is accepted that the substance of the Report was disclosed by the extract from the minutes of the MEC attached to the letter of 2 September 2004.
The respondents to the proceeding are the Chair of the Poisons Committee, the Secretary of the Poisons Committee and the Commonwealth. The Commonwealth is not properly a party since no relief is sought against the Commonwealth. The Chair and Secretary of the Poisons Committee are joined because the relief claimed in the application, as formulated, seeks to impugn the decision of the Chair to list, for consideration by the Poisons Committee, the revocation of the existing exemption for quinine, and the decisions of the Chair and the Secretary not to defer the consideration of that matter until a later meeting.
No complaint, however, is made as to the appropriateness of joinder of the first and second respondents as the decision‑makers in relation to those decisions. In essence, the real complaint is not so much as to those procedural decisions as to the possibility of a substantive decision being made by the Poisons Committee to amend the current Poisons Standard in the way that has been suggested by removing the qualification to the reference to quinine in Schedule 4.
The respondents resist the claim on the basis that a consideration of the language of the Therapeutic Goods Act and the Regulations suggests that together, they evince an intention on the part of the Legislature and the Executive to qualify the extent to which a person in the position of Pro-Health would be entitled to procedural fairness in respect of the decision that is presently contemplated and may be made at the meeting of the Poisons Committee tomorrow. The specific basis for that contention involves recognising the distinction between the function of the Poisons Committee in the overall scheme of the legislation, and to contrast its function with, for example, the process involved in having a substance registered.
Reference was made in the correspondence to a dispute between Pro-Health and the TGA concerning the registration of NICOBREVIN. Division 2 of Part 3-2 of Chapter 3 of the Therapeutic Goods Act deals with registration:
‘23(1) An application for registration or listing of therapeutic goods must:
(a) be made in accordance with a form approved
…
25 (1) Where:
(a)an application is made for the registration of therapeutic goods…
the goods are to be evaluated for registration…
…
(3) After therapeutic goods have been evaluated for registration, the secretary must:
(a)notify the applicant in writing of his or her decision on the evaluation… and in the case of a decision not to register the goods, of the reasons for the decision.’
Section 60 deals with review of decisions.
’60 (2) A person whose interests are affected by the initial decision [of the Secretary or a delegate of the Secretary inter alia, under part 3-2] may… request the Minister to reconsider the decision.
(3) …the Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and…
(a) either confirm the initial decision; or
(b) revoke the initial decision……
(8) An application may be made to the Administrative Appeals Tribunal for review of a [decision of the Minister].’
That is the process that was apparently invoked in relation to the registration of NICOBREVIN in the first place. The Therapeutic Goods Act contemplates various committees whose functions are to consider specific goods and applications made by specific individuals in relation to specific goods. The Poisons Committee on the other hand, performs a function of a different nature. It is not concerned with the assessment of specific products or goods but is concerned with the safety of substances that may or may not be included or incorporated into products or goods.
Whether or not the common law or general rules of procedural fairness are excluded by the scheme of the Act, I have concluded, not without difficulty, that there has been no denial of procedural fairness hitherto and that there is no threat of a denial of procedural fairness. The decision of the Poisons Committee is clearly an administrative one. Its deliberations must be in accordance with the Regulations. However, it is required to act with as little formality and as quickly as the requirements of the Regulations and a proper consideration of the issues allow. It is not bound by the rules of evidence and may obtain information about an issue in any way it considers appropriate.
I do not consider that those provisions operate to exclude the general rules requiring procedural fairness. However, while I do not consider that the scheme of the Therapeutic Goods Act and the Regulations cut down any entitlement to procedural fairness as such, the scheme dictates the content of procedural fairness in relation to decisions made under the Therapeutic Goods Act and the Regulations. The scheme indicates what is to be regarded as procedural fairness in circumstances such as this.
It is not a denial of procedural fairness, in the context of an administrative decision, for a party not to be given complete and full information as to all of the evidence intended to be relied upon by the decision-maker. It is necessary, however, that, to the extent that there is adverse material to be relied upon by the decision-maker in making its decision, a person who might be affected by the decision should be given a reasonable opportunity to respond to that adverse material. The adverse material in the present case is not that a particular individual has made a report, although the fact that a particular individual had made a report that was to be relied upon could, in some circumstances, amount to relevant adverse information. For example, if there were evidence to suggest that the standing of the author of a report was such that very great significance would be attached to the report simply because of the standing of its author, that might be a material factor that should be disclosed to somebody adversely affected, so that the person would be in a position, if need be, to suggest that the expertise of that individual were not such as to justify such reliance. However, that is not this case. The mere identity of the individual who made the Report does not, it seems to me, constitute a matter of substance so far as the proposed decision is concerned.
Further, as I have indicated, it is not suggested that there is anything in the shaded parts of the Report that is of significance. That is to say, as I understand what has been put on behalf of Pro-Health, it is not suggested that the minutes of the MEC meeting of 3 June 2004 did not disclose the substance of the Report so as to enable Pro-Health to respond to any adverse material contained in it. There is nothing before me to suggest that notification on 9 September 2004 of the substance of the Report was inadequate to enable Pro-Health to be able to respond by 12 October 2004, having regard to the extension afforded by the secretary of the Poisons Committee. It is significant also that the correspondence in January and February of this year served to draw the attention of Pro-Health to the concerns that were being expressed as to the possibility of a link between quinine and thrombocytopenia.
I do not consider, on balance, that in the circumstances there will be a denial to Pro-Health of procedural fairness if the Poisons Committee proceeds tomorrow to consider the question of whether or not the proposed amendment to Schedule 4 should proceed. It is not necessary, therefore, to deal with the other bases upon which the respondents resist the claims by Pro-Health. In my opinion, therefore, the application should be dismissed.
I certify that the preceding forty-six (46) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Emmett. Associate:
Dated:
Counsel for the Applicant: A Anforth Solicitor for the Applicant: Capital Lawyers Solicitor for the Respondent: A Markus, Australian Government Solicitor Date of Hearing: 11 October 2004 Date of Judgment: 11 October 2004
1
0
0