Actelion Pharmaceuticals Australia Pty Limited and Minister for Health and Ageing
[2008] AATA 227
•20 March 2008
Administrative Appeals Tribunal
DECISION AND REASONS FOR DECISION [2008] AATA 227
ADMINISTRATIVE APPEALS TRIBUNAL )
) No 2007/3928
GENERAL ADMINISTRATIVE DIVISION ) Re ACTELION PHARMACEUTICALS AUSTRALIA PTY LIMITED Applicant
And
MINISTER FOR HEALTH AND AGEING
Respondent
DECISION
Tribunal: Dr T. Baker, Member Date:20 March 2008
Place:Sydney
Decision: For the reasons given in this decision I direct that:
1. Pursuant to subsection 35(2)(c) of the Administrative Appeals Tribunal Act 1975, the extract of the transcript of the ADEC meeting held on 2 February 2007 (unredacted) is not to be released.
2. On or before 7 April 2008 the respondent is to lodge with the Tribunal and serve on the applicant a copy of the extract of the transcript of
the ADEC meeting held on 2 February 2007 with the names of the ADEC members or any information that may divulge the identity of the ADEC members redacted.
3. Pursuant to subsection 35(2)(c) of the Administrative Appeals Tribunal Act 1975, access to the extract of the transcript of the ADEC meeting held on 2 February 2007, redacted as specified in direction 2, be restricted to the member or members of the Tribunal constituted for the purpose of any proceeding in relation to this matter, staff of the Tribunal in the course of performing duties as a member of staff, the applicant's legal representatives and consultants appointed by the applicant in relation to these proceedings, and officers of the respondent, the respondent’s legal representatives and those persons whom the respondent involves in the preparation and conduct of proceedings on its behalf.
For the reasons detailed in this decision, I decline to direct the respondent to identify the ADEC member/s who formulated the recommendation at the meeting of 2 February 2007 and produce the curricula vitae of ADEC members and the original audio tapes of the ADEC meeting.
.................[sgd].............................
Dr T. Baker
Member
CATCHWORDS
HEALTH AND AGEING ─ practice and procedure – application for registration of ZAVESCA capsules − rejection of application for registration on the grounds of deficiencies in bioavailability, and inconclusive safety and efficacy concerns − initial decision − partial review − Respondent seeks order restricting disclosure of “Extract of the 250th (2007/01) meeting of the ADEC dated 2 February 2007” to the Applicant − objection by Applicant to confidentiality order being made − Applicant seeks additional materials to be included in the documents lodged by the Respondent pursuant to section 37 of the Administrative Appeals Tribunal Act 1975 – approval of an application for registration depends on the quality, safety and efficacy of the good for the purposes for which it is to be used being satisfactorily established − orders made.
Therapeutic Goods Act 1989 (Cth), sections 25 and 60
Administrative Appeals Tribunal Act 1975 (Cth), sections 35 and s 37
Therapeutic Goods Regulations 1990 (Cth), regulation 36
Re Pochi and Minister for Immigration and Ethnic Affairs (1979) 2 ALD 33
Re Telstra Corporation Limited and Department of Broadband, Communications and the Digital Economy [2007] AATA 2100
REASONS FOR DECISION
20 March 2008 Dr T. Baker, Member 1.Actelion Pharmaceuticals Australia Pty Limited (“Actelion”) is the Australian sponsor of the drug miglustat (ZAVESCA®).
2.Actelion submitted an application on 14 October 2005 to the Therapeutic Goods Administration (“TGA”) to register ZAVESCA capsules, containing miglustat 100 mg, for:
●the oral treatment of patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy (ERT) is unsuitable (“first indication”); and
●oral maintenance therapy of patients with type 1 Gaucher disease stabilised on enzyme replacement therapy (“second indication”).
3.Following evaluation of Actelion’s application for registration of ZAVESCA, the Delegate of the Secretary of the Department of Health and Ageing (“Delegate”) proposed to the Australian Drug Evaluation Committee (“ADEC”) that there should be no objection to the approval of ZAVESCA for the first indication but recommended rejection of the second indication. This accorded with the recommendation of the clinical evaluator.
4.Notwithstanding the Delegate’s recommendation, at its 250th meeting held on 2 February 2007, ADEC recommended rejection of both indications on the grounds of deficiencies in bioavailability, inconclusive efficacy and safety concerns.
5.The Delegate decided to accept ADEC’s recommendation and refused registration of both indications.
6.On 2 March 2007, the Delegate notified Actelion of his decision (“initial decision”) to refuse the registration of ZAVESCA on the grounds of inconclusive efficacy in both indications.
7.On 28 May 2007, Actelion submitted an appeal to the Minister of Health and Ageing (“Minister”), pursuant to section 60 of the Therapeutic Goods Act 1989 (Cth) (“TG Act”), for a review of the initial decision.
8.On 27 July 2007, the Delegate of the Minister:
●revoked the initial decision to reject the application for the first indication and replaced it with the decision, pursuant to section 25 of the TG Act, to approve the registration of Zavesca capsules containing miglustat 100 mg for the oral treatment of patients with mild to moderate Type 1 Guacher disease for whom enzyme replacement therapy is not a therapeutic option; and
●confirmed the initial decision to reject the application for the second indication.
9.Actelion has submitted an application to the Tribunal for a partial review of the decision of the Minister’s Delegate, viz whether the respondent’s decision to confirm the initial decision to reject the application for the second indication is the correct and preferable decision.
10.In the course of the proceedings, the respondent has requested that the Tribunal make an order pursuant to section 35(2) of the Administrative Appeals Tribunal Act1975 (Cth) (“the AAT Act”) restricting disclosure of documents lodged pursuant to section 37 of the AAT Act to the Applicant. The Tribunal has made two orders, with the consent of the Applicant.
11.However, Actelion has opposed the Respondent’s request to restrict disclosure of the “Extract of the 250th (2007/01) meeting of the ADEC dated 2 February 2007” (“ADEC transcript”).
12.On the day of the hearing which considered the application for a confidentiality order, Actelion lodged with the Tribunal “Submission’s [sic] concerning the transcript and tapes of the Australian Drug Evaluation Committee” which stated:
1. The Applicant seeks disclosure of the following as part of the T documents:
(a)The identity of the ADEC member/s who formulated the recommendation at the meeting of 2 February 2007;
(b)The Curriculum Vitae of the ADEC members referred to above with disclosure of their relevant experience with Gaucher’s disease and of any historical, ideological or financial association with any drug company actively involved in the treatment of Gaucher’s disease.
(c) The transcript and the original audio tapes of the ADEC meeting;
2.In the alternative the Applicant seeks a ruling that the Tribunal does not recognise ADEC’s recommendations as that of a relevant expert for the purposes of the proceedings.
13.There arise, from these submissions, two issues for the Tribunal’s consideration:
·Firstly, whether a confidentiality order, pursuant to section 35 of the AAT Act, should be made in respect of the ADEC transcript; and
·Secondly, whether an order should be made, pursuant to subsection 37(2) of the AAT Act, directing the Respondent to identify the ADEC member/s who formulated the recommendation at the meeting of 2 February 2007 and to produce the curricula vitae of the ADEC members who formulated the recommendation at the meeting of 2 February 2007 and the original tapes of the ADEC meeting.
14.With respect to the application for a confidentiality order to be made restricting disclosure of the ADEC transcript, section 35 of the AAT Act relevantly provides:
35 Hearings to be in public except in special circumstances
…
(2)Where the Tribunal is satisfied that it is desirable to do so by reason of the confidential nature of any evidence or matter or for any other reason, the Tribunal may, by order:
…
(c)give directions prohibiting or restricting the disclosure to some or all of the parties to a proceeding of evidence given before the Tribunal, or of the contents of a document lodged with the Tribunal or received in evidence by the Tribunal, in relation to the proceeding.
(3) In considering:
…
(b)whether publication, or disclosure to some or all of the parties, of evidence given before the Tribunal, or of a matter contained in a document lodged with the Tribunal or received in evidence by the Tribunal, should be prohibited or restricted;
the Tribunal shall take as the basis of its consideration the principle that it is desirable that hearings of proceedings before the Tribunal should be held in public and that evidence given before the Tribunal and the contents of documents lodged with the Tribunal or received in evidence by the Tribunal should be made available to the public and to all the parties, but shall pay due regard to any reasons given to the Tribunal why the hearing should be held in private or why publication or disclosure of the evidence or the matter contained in the document should be prohibited or restricted.
15.Subsection 35(3) specifies that, in considering whether to make an order restricting disclosure to some or all of the parties of a matter contained in a document lodged with the Tribunal, the Tribunal is required to “take as the basis of its consideration the principle that it is desirable that … the contents of documents lodged with the Tribunal … should be made available to the public and to all the parties”.
16.However, the provision acknowledges, that there may be circumstances which warrant restricting the disclosure of matters contained in documents lodged with the Tribunal. In Re Pochi and Minister for Immigration and Ethnic Affairs (1979) 2 ALD 33 then President Brennan J suggested that such circumstances would be expected to arise infrequently, saying at pages 55-56:
… the powers conferred upon this Tribunal by s 35(2) are not intended to lie dormant – they are there to be exercised, albeit sparingly. The purpose of their exercise is to secure to the Tribunal the availability of as much relevant information as possible, without violating the confidentiality which a party, a witness or the public is properly entitled to preserve (though a proper entitlement to confidentiality is not lightly established). A court may be constrained to violate that confidentiality in order to conduct its proceedings in public; but the Tribunal’s powers are intended to facilitate the flow of relevant information to it, and if the exclusion of the public or even of a party is essential to preserve the proper confidentiality of the information needed to determine the application, that is a price which has to be paid, however reluctantly.
An order excluding the public may be justified more readily than an order excluding a party, but strict criteria govern the making of such an order. There must appear a real possibility of doing injustice to, or inflicting a serious disadvantage upon, a party, a witness or a person giving information if the proceedings were in public; or it must clearly appear that publication of the proceedings would be contrary to the public interest; or it must appear that the information to be given in the proceedings is of a kind described by s 36 (though in the last case, it is relevant that the Attorney-General has not given a certificate under that section). Where it is contended that publication of the proceedings would be contrary to the public interest, it is difficult to envisage a case justifying exclusion of the public which a court would not deal with by refusing to admit the evidence: this class of case is a narrow one. Where the publicity which traditionally marks curial proceedings may inhibit the production of evidence or lead to its rejection, the power conferred upon the Tribunal by s 35(2) authorises it to remove those impediments to the receipt of information. Yet the power is conferred in order to do justice in exceptional cases - that is to say, where ‘the principle that it is desirable that hearings of proceedings before the Tribunal should be held in public’ cannot be applied....
17.The provision instructs that due regard be paid “to any reasons given to the Tribunal … why publication or disclosure of the evidence or the matter contained in the document should be prohibited or restricted”. As noted by Deputy President Forgie in Re Telstra Corporation Limited and Department of Broadband, Communications and the Digital Economy [2007] AATA 2100 at [48]:
Some of those reasons will be found in the modifications to s 35 found in the modifications made by a particular enactment. In others, they may be found in what is relevant to the resolution of the issues that need to be decided and the nature of the evidence and the effect that its disclosure may have on persons connected or unconnected with the hearing.
18.The Respondent seeks a confidentiality order that prevents the ADEC transcript from being released to the applicant on the grounds that the deliberations of ADEC are confidential and release of the transcript would impede frank discussions of committee members.
19.ADEC is a statutory committee appointed by the Minister pursuant to regulation 36 of the Therapeutic Goods Regulations1990 (Cth).
20.The role of ADEC includes the medical and scientific evaluation of medicines that are referred to it. ADEC provides independent, expert scientific advice to the Delegate to assist the Delegate in making the initial decision. An important feature of ADEC is that it provides its advice as a collective expert body, and has particular expertise in the evaluation of high risk new chemical entities.
21.Although it is the decision of the Minister's Delegate that is the reviewable decision, the advice of ADEC is important in the decision-making process. The Minister's Delegate states in his decision upon reconsideration that he relied, inter alia, on both the relevant extracts from the minutes of the 250th meeting of the ADEC held on 2 February 2007, and the transcript of the discussion of the application at that meeting. This suggests that the transcript contains additional relevant information that was not contained in the extracts from the minutes, but was considered by the Minister’s delegate in making his decision. Accordingly, insofar as the transcript contains additional relevant information that may assist the Tribunal and the parties to the proceedings to understand the reasoning behind ADEC's recommendation, I am prepared to make a confidentiality order in respect of the ADEC transcript (in a redacted form, for reasons detailed later in this decision) which authorises the transcript’s release to the applicant's legal representatives and consultants appointed by the applicant in relation to these proceedings.
22.In addition to the release of the transcript, the Applicant has requested that an order be made directing the respondent to identify the ADEC member/s who formulated the recommendation at the meeting of 2 February 2007, to produce the curricula vitae of those members and to release the original tapes of the ADEC meeting.
23.Subsection 37(2) of the AAT Act relevantly provides:
37 Lodging of material documents with Tribunal
…
Decision‑maker must lodge statement of reasons and relevant documents
(1)Subject to this section, a person who has made a decision that is the subject of an application for a review by the Tribunal must, within 28 days after receiving notice of the application (or within such further period as the Tribunal allows), lodge with the Tribunal 2 copies of:
(a)a statement setting out the findings on material questions of fact, referring to the evidence or other material on which those findings were based and giving the reasons for the decision; and
(b)every other document or part of a document that is in the person’s possession or under the person’s control and is relevant to the review of the decision by the Tribunal.
…
Tribunal may require other documents to be lodged
(2)Where the Tribunal is of the opinion that particular other documents or that other documents included in a particular class of documents may be relevant to the review of the decision by the Tribunal, the Tribunal may cause to be given to the person a notice in writing stating that the Tribunal is of that opinion and requiring the person to lodge with the Tribunal, within a time specified in the notice, the specified number of copies of each of those other documents that is in his or her possession or under his or her control, and a person to whom such a notice is given shall comply with the notice.
…
24.In relation to the ADEC meeting, the applicant raised concerns about possible bias in relation to ADEC's recommendation and reasoned that the identity of the ADEC members was relevant to determine whether or not discussions were dominated by one member and whether or not issues of bias influenced ADEC's recommendation that Actelion's application for ZAVESCA be rejected.
25.Issues of bias are matters for judicial review and not for consideration by the Tribunal, which is concerned with merits review. Notwithstanding that, I do not accept that the identity of ADEC members is relevant to these proceedings. Primarily, approval of an application for registration centres around whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established (section 25(1)(d) of the TG Act).
26.In that regard, registration is justified if Actelion can demonstrate a satisfactory level of quality, safety and efficacy for ZAVESCA for the proposed indications. This is necessarily a scientific argument and it is on the strength of the scientific evidence that the Tribunal will largely base its decision.
27.The relevant extracts from the minutes of the ADEC meeting and the transcript of the discussion of Actelion's application at that meeting set out the reasoning behind ADEC’s recommendation, and these provide sufficient information for Actelion to understand the reasons ADEC recommended rejection of their application. It is not necessary, however, for Actelion to know the identity of ADEC members to understand the reasons for rejection and establish why ADEC considered that the statutory test in relation to quality, safety and efficacy had not been satisfied.
28.Furthermore, it is important to emphasise that ADEC was not the decision-maker. The Delegate made the initial decision, taking into account the totality of evidence, including the original submission, any subsequent data submitted by the applicant, evaluation reports, the Delegate’s overview, the applicant’s pre-ADEC response and ADEC’s recommendation.
29.Similarly, in his decision upon reconsideration, the Minister’s Delegate considered a large amount of evidence, not only ADEC’s deliberations. There is no evidence that the Minister’s Delegate gave undue weight to ADEC’s recommendation. Indeed, the decision of the Minister’s Delegate to revoke the initial decision to refuse registration of the first indication is contrary to ADEC’s recommendation, and indicates that other evidence plays an important role in the decision-making process.
30.With the above in mind, and given that Actelion’s application to the Tribunal seeks review of the decision of the Minister’s Delegate, I do not consider that the disclosure of the identity of the ADEC members is warranted, or that Actelion’s interests are affected by non-disclosure. I direct, therefore, that the names of ADEC members or any information that may divulge the identity of ADEC members be redacted from the ADEC transcript.
31.With respect to Actelion's request for the Tribunal to make a order to release the original tapes of the ADEC meeting, I am not prepared to grant such an order. The transcript records the relevant discussion in its entirety and is, in this regard, sufficient for the applicant's purposes. More importantly, the original tapes also include the Committee's deliberations in relation to other drugs and the release of the tapes is, therefore, is not appropriate.
DECISION
32.For the reasons given in this decision I direct that:
1.Pursuant to subsection 35(2)(c) of the Administrative Appeals Tribunal Act 1975, the extract of the transcript of the ADEC meeting held on 2 February 2007 (unredacted) is not to be released.
2.On or before 7 April 2008 the respondent is to lodge with the Tribunal and serve on the applicant a copy of the extract of the transcript of the ADEC meeting held on 2 February 2007 with the names of the ADEC members or any information that may divulge the identity of the ADEC members redacted.
3.Pursuant to subsection 35(2)(c) of the Administrative Appeals Tribunal Act 1975, access to the extract of the transcript of the ADEC meeting held on 2 February 2007, redacted as specified in direction 2, be restricted to the member or members of the Tribunal constituted for the purpose of any proceeding in relation to this matter, staff of the Tribunal in the course of performing duties as a member of staff, the applicant's legal representatives and consultants appointed by the applicant in relation to these proceedings, and officers of the respondent, the respondent’s legal representatives and those persons whom the respondent involves in the preparation and conduct of proceedings on its behalf.
33.For the reasons detailed above I decline to direct the respondent to identify the ADEC member/s who formulated the recommendation at the meeting of 2 February 2007 and produce the curricula vitae of ADEC members and the original audio tapes of the ADEC meeting.
I certify that the 33 preceding paragraphs are a true copy of the reasons for the decision herein of Dr T. Baker, Member
Signed: ...[sgd].........................................................................
AssociateDate of Hearing: 6 December 2007
Date of Decision: 20 March 2008
Counsel for the Applicant: Mr A. Anforth
Solicitor for the Respondent: Ms J. Pownall, Australian Government Solicitor
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