Montagner and Secretary, Department of Health and Aged Care (Freedom of information)
[2023] AATA 1443
•25 May 2023
Montagner and Secretary, Department of Health and Aged Care (Freedom of information) [2023] AATA 1443 (25 May 2023)
Division:FREEDOM OF INFORMATION DIVISION
File Number: 2021/5671
Re:Carlo Montagner
APPLICANT
AndSecretary, Department of Health and Aged Care
RESPONDENT
DECISION
Tribunal:Senior Member D. J. Morris
Date:25 May 2023
Place:Melbourne
Pursuant to s 43(1)(b) of the Administrative Appeals Tribunal Act 1975 (Cth) (‘the AAT Act’) the Tribunal varies the reviewable decision, as amended by the Tribunal under s 26(1)(b) of the AAT Act, in the terms set out in Part 2 of the Reasons for Decision, herewith.
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Senior Member D. J. Morris
Catchwords
FREEDOM OF INFORMATION – information sought in relation to consideration by a non-statutory advisory committee relating to funding for development of a breast cancer treatment – Respondent claims exemptions and conditional exemptions for certain documents – application in part sought minutes of a meeting – what are minutes – where applicant claims he was denied procedural fairness in relation to an administrative process – what is before the Tribunal and what is not – observations by the Tribunal regarding measures to improve administrative processes – whether Respondent has been responsive in relation to particular documents – public interest considerations – decision under review varied
Legislation
Administrative Appeals Tribunal Act 1975 (Cth)
Corporations Act 2001 (Cth)
Freedom of Information Act 1982 (Cth)Health Insurance Act 1973 (Cth)
Cases
Director of Public Prosecutions v Smith [1991] 1 VR 63
Secondary Materials
The Concise Oxford English Dictionary (4th Edition); H.W. and F. G. Fowler (Eds); Clarendon Press
REASONS FOR DECISION
Senior Member D. J. Morris
25 May 2023
PART 1
Introduction
These Reasons are in three parts. Part 1 sets out the background, the submissions of the parties, and a summary of the documents in contest. It includes the oral evidence of three witnesses and observations by the Tribunal on two particular points of contention between the parties. Part 2 sets out the Tribunal’s decisions in relation to each of the documents. Part 3 is a brief summation of how the Tribunal reached its conclusions.
Background
The Applicant, Mr Carlo Montagner, operates a biopharmaceutical company, Specialised Therapeutics Australia (‘STA’) which, in the words of the company’s website, commercialises therapies and technologies to fulfil unmet medical needs in the community. The company links with global pharmaceutical companies to assist them to register products with the relevant regulatory authorities in the particular jurisdiction.
This matter relates to an application STA made to the Commonwealth Government for public funding in relation to a particular medical service, and Mr Montagner’s request for documents relating to the assessment of that medical service.
What is MSAC?
When new medical services are proposed for public funding by the Commonwealth Government, the proposer puts a submission to a committee established by the Minister for Health (‘the Minister’) called the Medical Services Advisory Committee (‘MSAC’). The Tribunal notes that, at the time of the Applicant’s submission, the department of state was the Department of Health, which has since been re-named to be the Department of Health and Aged Care. The Secretary of that Department is the Respondent in these proceedings.
MSAC was established by the then Minister for Health in 1998. It appraises the medical service and provides advice to the Commonwealth Government on whether a new service should be publicly funded on an assessment of its comparative safety, clinical effectiveness, cost-effectiveness, and total cost. Another role of MSAC is that it considers amendment and review of existing medical services funding on the Medicare Benefits Schedule and other programmes such as blood products or screening programmes, and provides advice to the Minister.
Importantly, MSAC is not a statutory committee. It is appointed by the Minister exercising executive power to perform an advisory role. It is a matter for the Government whether it accepts the advice of MSAC. The Department of Health and Aged Care (‘the Department’) provides administrative support to MSAC.
The Department’s website lists the membership of MSAC and states that the term of members is staggered to ‘reduce operational impact for future changes’. The current chair of MSAC is Professor Robyn Ward, AM, who is a medical oncologist and currently Executive Dean of Medicine at the University of Sydney. The website shows that the background of MSAC members ranges across different medical specialities, as well as allied health, health economics and pharmacy. There are two consumer representatives. The members are part-time and not officers of the Department. They receive fees set by the Remuneration Tribunal for serving on the Committee.
The application to MSAC
In February 2019 the Applicant made a submission to MSAC for public funding of a medical service. The medical service was described as ‘a gene expression profiling (GEP) test using Oncotype DX to predict the likelihood of adjuvant chemotherapy benefit in patients with early-stage breast cancer’. For brevity, the medical service will be described as ‘Oncotype DX’ in these reasons.
In his 7 February 2019 letter to the MSAC Application Manager (Exhibit R8), Mr Montagner observed that the application for Oncotype DX commenced in December 2011. He stated:
This is the Applicant’s sixth and, most likely final, submission to MSAC. The recent publication of the TAILORx trial and the high-quality evidence it provides for the safety of withholding chemotherapy in certain groups of patients answers many of MSAC’s previous concerns about the test. This submission shows that when used in a targeted population, Oncotype DX is a safe, effective and cost-effective tool to assist in the decision whether to use chemotherapy in the treatment of women with early-stage breast cancer.
The Applicant was advised on 14 August 2019 that he was unsuccessful in obtaining a recommendation from MSAC when his proposal was considered at the August 2019 MSAC meeting.
Request for documents
On 24 January 2020 the Applicant made a request to the Department for access to documents under the Freedom of Information Act 1982 (Cth) (‘the Act’). The documents sought were:
The minutes from the August 2019 Medical Services Advisory Committee meeting in relation to application 1342.5, which was consideration of the Oncotype DX Breast Cancer Assay to quantify the risk of disease and recurrence and predict adjuvant chemotherapy benefit (resubmission). In addition, I am further seeking the release of any and all written correspondence between MSAC committee [sic] members, between MSAC members and any person within the Department of Health including the Minister and his advisory staff relating to this application. This includes, but is not limited to, email correspondence from private or professional emails, as well as any text messages on department or personal mobile phones. This application further includes any written correspondence in any format between MSAC members discussing the submission.
On 29 January 2020 the Department acknowledged the Applicant’s request and sought clarification upon the scope of the request, contending to Mr Montagner that he had been provided with a copy of the ratified minutes for the August 2019 meeting of the MSAC. Mr Montagner reiterated the request in essentially the same terms.
On 12 February 2020 the Department advised the Applicant of the estimates of charges and invited him to revise the scope of his request. On 13 February 2020 Mr Montagner advised that he agreed to the fee estimates and wanted to proceed on the original scope of the request.
On 19 February 2020, in accordance with ss 27 and 27A of the Act, the Department consulted with three third parties in respect of information pertaining to their business and personal information: Dr Graeme Suthers, who is Director of Genetics at a pathology company, Sonic Pathology Australia; Dr Tim Spelman, who is a consultant biostatistician, and a third person, who is also a statistician.
Dr Suthers advised that he did not seek any exemption. Dr Spelman sought that personal correspondence contained in the material be exempt but did not object to his identity being disclosed. The third party and his employer sought that information in relation to their identity and professional affairs be exempt under ss 47F and 47G of the Act.
Original Decision by the FOI officer
On 23 March 2020 the authorised decision-maker under the Act in the Department notified Mr Montagner that she had (a) identified 23 documents falling within the terms of his request; (b) decided to grant access to the 23 documents in part; and (c) decided to withhold as irrelevant under s 22, or exempt under s 47C (deliberative process exemption); s 47E (certain operations of agencies exemption); s 47F (personal privacy exemption); and s 47G (business affairs exemption) of the Act, parts of the 23 documents, which she set out in a schedule to her decision letter.
I will call this decision of 23 March 2020 the Original Decision.
On 5 May 2020 Mr Montagner applied to the Office of the Information Commissioner (‘OIC’) for review of the decision, under s 54L of the Act. On 10 August 2021 the OIC made a decision under s 54W(b) of the Act not to undertake a review of the Original Decision.
On 17 August 2021 the Applicant sought a review of the Original Decision by this Tribunal.
Original Decision varied by consent
On 22 February 2022 at the request of, and with the consent of the parties, the Tribunal made an order under s 26(1)(b) of the AAT Act altering the terms of the Original Decision, after the Respondent agreed not to maintain claims for exemptions sought to certain specified documents.
On 2 June 2022, the Tribunal also issued an order under s 35(4) of the AAT Act prohibiting the publication, other than to the parties, of certain parts of affidavits deposed by Professor Ward and Ms Penny Shakespeare, a Deputy Secretary of the Department, both dated 6 May 2022.
On 2 June 2022 and again on 31 August 2022 the Tribunal, at the request of, and with the consent of the parties, made further orders under s 26(1)(b) of the AAT Act altering the Original Decision, after the Respondent agreed not to maintain claims for exemptions sought to specified documents.
The Original Decision before the Tribunal for review is therefore varied in its terms by the three orders made on 22 February, 2 June, and 31 August 2022. Each of those orders reduced the numbers of documents and redactions in contest.
HEARING
On 6 June 2022 and 8 and 9 August 2022 the Tribunal heard submissions from the parties and evidence. Owing to capacity restrictions imposed by the pandemic, although it was a public hearing there was a limit on the number of persons who could be present. Accordingly, the Tribunal agreed to several requests from media organizations, individuals, and cancer support organizations to listen to proceedings on a live stream. The Applicant was represented by Mr Patrick Noonan of counsel, instructed by Mr Andrew Flower of FCG Legal, Lawyers. The Respondent was represented by Dr Laura Hilly of counsel, instructed by Ms Melissa Gangemi of The Australian Government Solicitor.
Professor Ward and Mr Montagner gave evidence in person; Ms Shakespeare gave evidence by video-link by leave of the Tribunal under s 33A of the AAT Act.
On 15 September 2022 the Tribunal made orders allowing both parties to make closing submissions, after which the decision would be reserved. The last submission was received on 19 October 2022.
WHAT THIS MATTER IS ABOUT, AND WHAT IT IS NOT ABOUT
The function of the Tribunal in this review is to consider claimed exemptions by the Respondent for documents or parts of documents sought as part of the Applicant’s request, and to make decisions in relation to them. In this respect, the onus under the Act falls on the Respondent to argue why a particular exemption provided for under the Act is applicable to a document.
Where a conditional exemption is claimed, it is necessary in such cases for the Tribunal to be satisfied that a conditional exemption applies, and then the Tribunal must be satisfied under s 11A of the Act that, on balance, it would be contrary to the public interest if access was given to a conditionally except document. In considering the public interest, s 11B of the Act sets out factors in favour of providing access to documents (which is of course the object of the regime established under the Act).
During the course of the hearing, the Applicant and his legal representative made certain submissions about the process followed by MSAC in considering the Oncotype DX request for support. In particular, the Applicant was aggrieved that MSAC considered an email from an individual, Dr Suthers, who is a director of a pathology company, and who had been a past member of MSAC, though not at the time Mr Montagner’s most recent application was considered. Secondly, the Applicant was dissatisfied with the documentation provided by the Department in response to his FOI request, especially in relation to the minutes of the August 2019 MSAC meeting.
The Tribunal here is making administrative decisions. It starts from the principle articulated in s 11 of the Act that, subject to the Act, every person has a legally enforceable right to obtain access to documents other than exempt documents.
In undertaking this task, the Tribunal is not empowered to examine or make findings about administrative processes of Government agencies. In deciding whether to affirm, set aside or vary a decision under the Act, the Tribunal has a two-part role. It must be satisfied whether a claimed exemption applies under a particular part of the Act and also whether, on balance, it is satisfied that it would be contrary to the public interest if access is given to the conditionally exempt document (s 11A(5)). That is the range of the task.
However, the Tribunal will make some limited observations about two particular matters because both relate directly to documents within the scope of the FOI request.
THE RESPONDENT’S POSITION
Counsel for the Respondent set out the role of MSAC:
MSAC receives applications from companies, like it did for Specialised Therapeutics Australia – they’re often complex and technical – and its job is to assess their relative strength on the available evidence. It’s a multi-factorial, multidiscipline assessment, and this goes beyond just the science of the product. It considers such things as comparative safety, clinical evidence and the cost effectiveness in the Australian context.
The evidence that will be before the Tribunal…is that when the committee considers these applications, with the benefit of assistance from technical experts and others in the Department, MSAC then convenes a meeting to deliberate on the applications. It decides in a confidential session whether to support, not support or defer its advice on the application. It’s important to emphasise that they do not make a decision on the application but rather give advice to the Minister. Then it will communicate its position to the applicant and to the Minister directly after that meeting. What MSAC then does is prepares a document which is detailed minutes, and something called a public summary document, which has been referred to as the PSD. This formally records the MSAC advice to the Minister and the rationale for the advice and the summary of facts that are relied upon in providing that advice. So, given the detail and technical nature of that document, it’s a process that can take some time.
In response to direct questions from the Tribunal, Dr Hilly submitted that the Minister is not bound by the advice he receives from MSAC but that it is more likely than not that the Minister would not place a medical service on the Medical Benefits Schedule if it was not recommended by MSAC.
In this case, the Respondent submitted that the Public Summary Document (‘PSD’) included a lay summary, so it could be understood by the general public, as well as recording technical information that was taken into account by MSAC when arriving at its decision. Dr Hilly told the Tribunal that it is commonplace for an unsuccessful applicant to meet with Department officers to get feedback on an unsuccessful application and that, in this case because there had been a high number of previous applications for this medical service, further steps were taken to engage with STA.
MSAC decided on 1 August 2019 that STA’s application was not successful, and Mr Montagner was informed on 14 February 2019. The PSD was then prepared, ratified by MSAC members, and provided to STA on 29 January 2020, before being posted on MSAC’s website on 20 February 2020. On 16 April 2020 Mr Montagner and others from STA met with Professor Ward to discuss the matter.
In response to a direct question from the Tribunal, counsel for the Respondent explained that when an applicant applies for a medical service to be considered by MSAC, that is notified on the MSAC website, which gives an opportunity for third parties to comment on an application. The Respondent told the Tribunal that an ‘alert’ bulletin is circulated advising interested persons of medical service applications that MSAC will consider at a future meeting. Persons can subscribe to this bulletin, as well as being able to see applications on the MSAC website.
The Respondent noted that the Applicant submitted in his closing submissions ‘whether it is in the public interest for MSAC’s processes and procedures to be subject to public scrutiny under the FOI Act’. In response, the Respondent submitted that:
MSAC’s processes and procedures are already in the public domain, proactively published on the MSAC website. They have been the subject of detailed evidence in these proceedings. The Applicant may disagree with the processes previously or currently adopted by MSAC and the Department. He may consider there is room for improvement, or critique their application. This is not a legal issue before this Tribunal. Any amendments to those processes are a matter for the Department and the responsible Minister.
The Respondent submitted that the exemptions claimed are over documents which would reveal the content of confidential deliberations of MSAC and the Department in relation to MSAC’s appraisal of the application made by Mr Montagner’s company for public funding for Oncotype DX and the preparation of the public rationale for that appraisal, published in the form of what is called the PSD. The Respondent submitted that the release of this confidential deliberative material is likely to have a substantial and adverse effect on the proper and efficient conduct of MSAC and the Department.
The Respondent particularised this effect by submitting that release of the material on which exemptions are claimed would (a) undermine the principle of collective decision-making, which underpins MSAC’s advisory functions; (b) unfairly expose statements made by individual MSAC members which could result in ‘professional harm and pressure, in turn compromising the retention of current MSAC members and its capacity to recruit new members’; and (c) disrupt the effective and efficient functioning of MSAC which was suggested would be likely to have a ‘substantial impact on the capacity of the Department’ to advise the Minister when he is exercising his functions under the Health Insurance Act1973 (Cth).
The Respondent in his closing submissions noted that both parties have made concessions since the original application for review by the Tribunal was lodged. The Applicant no longer presses for documents over which a s 22 (essentially, irrelevant documents) claim has been made. The Respondent no longer presses for an exemption under s 47G (public interest conditional exemptions – business) and has given the Applicant other documents over which earlier s 47C (public interest conditional exemptions – deliberative processes) and s 47E(d) (public interest conditional exemptions – certain operations of agencies) claims had been made.
The documents in dispute
The Respondent helpfully provided a short description of the nature of the documents still in dispute between the parties. There are 23 in total. The first group relate to the lead up to the MSAC meeting in August 2019 which considered the Applicant’s proposal.
Documents 1 to 4
These are emails from the Department to members of MSAC and the Evaluation Subcommittee of MSAC attaching electronic meeting invitations and draft meeting agendas for a meeting of the subcommittee on 13 June 2019 and of MSAC on 1 and 2 August 2019. The Respondent noted that information in those documents not relating to the Applicant’s application has been redacted as irrelevant, and that other redactions on these documents include personal email addresses of MSAC members not otherwise publicly available; names and email addresses of persons not employed by the Department providing administrative support to MSAC members; names and email addresses of Department staff not of Senior Executive Service (SES) level providing administrative support to MSAC and, in the agendas themselves, the names of particular committee members who were allocated to consider STA’s medical service application as ‘discussant’.
Document 5
This document is what the Respondent describes as consultation feedback received from a member of the public, Dr Graeme Suthers, director of Sonic Pathology Australia.
Document 6
This is correspondence between an MSAC member and Mr Andrew Mitchell, then an officer of the Department in the Office of Health Technology Assessment Branch. The correspondence attached a journal article which has been released to the Applicant.
Document 7
This is correspondence between the Department and MSAC members in the lead up to the MSAC meeting on 1 August 2019. One of the MSAC members asks for the Clinical Study Report for the TAILORx trial and is advised by the Department that neither the Applicant nor the sponsor (Genomic Health Inc) have a copy of the Clinical Study Report.
Document 8
This is an email from the Department to MSAC members forwarding correspondence between STA and the Department regarding the Clinical Study Report for the TAILORx trial. STA advise that if MSAC has specific questions about the study they should contact Dr Joseph Sparano directly. Dr Sparano is the specialist medical practitioner who conducted the study.
Document 9
This is correspondence between MSAC members and Mr Mitchell discussing the content of STA’s application in advance of the MSAC meeting. It includes a text message between Mr Mitchell and an MSAC member and attachments to the email correspondence.
Document 10
This is a text message between an MSAC member and Mr Mitchell seeking a discussion before the MSAC meeting.
The next group of documents are temporally after the August 2019 MSAC meeting.
Document 11
This is correspondence between MSAC members, and between MSAC members and the Department, regarding an earlier draft of what the Respondent describes as the unratified minutes prepared in the format of the PSD. When the comment of the Applicant is included, it becomes what is described as the ‘published PSD’.
Document 12
This is correspondence among MSAC members and between MSAC members and the Department regarding what the Respondent describes as ‘a further draft of the MSAC minutes/PSD’. It also includes draft correspondence from the MSAC chair.
Document 13
This document is no longer in issue between the parties.
Documents 14 to 18
These documents are correspondence among MSAC members and between MSAC members and the Department regarding a further draft PSD, attaching copies of those further drafts. It also includes draft correspondence from the MSAC chair.
Document 19
This is correspondence among MSAC members, and between MSAC members and the Department, regarding a further draft PSD, including correspondence from Dr Tim Spelman, a third-party consultant who performing a statistical review of MSAC’s statistical methods and analysis to ensure that it was properly addressed to a technical audience.
Document 20
This is correspondence between the Department and MSAC about the ratification of the draft PSD.
Documents 21 to 23
These documents are further correspondence among MSAC members and between MSAC members and the Department regarding a further draft of the PSD in the lead up to its finalisation in January 2020, and other draft communications.
THE APPLICANT’S SUBMISSIONS
The Applicant submitted that MSAC is an agency for the purposes of the Act. He further submitted that:
Although each of the Secretary’s conditional exemption claims must be considered on its merits, the common thread in this proceeding is whether it is in the public interest for MSAC’s processes and procedures to be subject to public scrutiny under the FOI Act; or whether it is in the public interest that MSAC’s operations affecting $27.5 billion of recurrent public expenditures be concealed from the public.
The Applicant noted that from 1 July 2021 there were changes to MSAC procedures so as to require public feedback by a defined date, as confirmed in Ms Shakespeare’s second affidavit.
The Applicant noted that the Remuneration Tribunal has substantially increased the fees payable to MSAC members and, while not criticising the increase, submitted that this would have an effect on arguments put by the Respondent that unreasonable disclosure of the deliberative processes within MSAC would have a harmful impact on retaining current members or recruiting new persons to sit on the committee.
The Applicant repeated a call for the minutes of the August 2019 MSAC meeting, noting the evidence of Ms Shakespeare that the contractors who provide administrative support for MSAC meetings take contemporaneous notes at the meetings of the committee, which are subsequently converted into PSDs relating to the proposals considered.
The Applicant summarised the public interest test provisions in the Act and submitted that it is not necessary for a matter to be in the interest of the public as a whole; it may be sufficient that the matter is in the interest of a section of the public bounded by a characteristic that depends upon the particular situation. Mr Noonan submitted that a matter of particular interest or benefit to an individual or small group of people may also be of general public interest.
The Applicant submitted that the Secretary’s submissions that access to documents may result in people misinterpreting the role of the discussant (i.e., a member chosen to lead discussion at an MSAC meeting on an agenda item) and individual Committee members is precluded by the stipulations in s 11B of irrelevant factors which must not be considered in weighing the public interest.
Section 11B of the Act provides that a decision-maker (in this case the Tribunal) must not take into account whether access to a document would result in embarrassment to the Commonwealth Government, or cause a loss of confidence in the Government; that access could result in any person misinterpreting or misunderstanding the document; that the author of the document was or is of high seniority in the agency to which the request was made; or that access to the document could result in confusion or unnecessary debate.
Mr Noonan submitted that much of the reasoning of the Respondent rests on factors that are specified as irrelevant in applying the public interest test, including some of the contents of the affidavits by the MSAC Chair.
Mr Noonan submitted for the Applicant that it is in the public interest that there should be public confidence in MSAC and the performance of its functions. He further submitted that the evidence of Ms Shakespeare, a Deputy Secretary of the Department, about the PSDs are that the PSD is intended to be useful for different stakeholders, including the public at large, members of the public who may be interested in a particular therapy, doctors who may be interested in providing such a therapy, government agencies that might be involved in funding, others who might bring forwards similar therapies, and the Applicant himself. Mr Noonan submitted that in this case ‘the PSD as a transparent disclosure of the decision has miscarried. Greater disclosure may not be justified in all instances, but ‘in the circumstances’ of this case, greater disclosure than usual is necessary in the public interest’.
ORAL EVIDENCE
Ms Penny Shakespeare
Ms Shakespeare, who is a Deputy Secretary of the Health Resourcing Group of the Department, gave evidence. She has made two affidavits that were before the Tribunal.
Ms Shakespeare gave evidence about changes in the fee rate for the chair, deputy chairs and members of MSAC, including that members now received an annual fee, rather than a per diem payment.
Ms Shakespeare also gave evidence about the changes to the process of MSAC so as to allow an applicant to receive public submissions and give them the opportunity to respond. She agreed with Mr Noonan that two purposes of this change were to allow the committee to have ‘both sides’ of the case raised in the submission and to ensure procedural fairness.
Ms Shakespeare agreed, in relation to how public submissions were treated in 2019, that it would “have been preferable if there had been an opportunity to respond. It wasn’t, I don’t think, the case in this circumstance. And it wasn’t required under the guidelines or procedures that were in place at the time.”
Ms Shakespeare told the Tribunal that Department officers attend meetings of MSAC and take minutes of the meeting. She said that the meetings are recorded and that a person also makes either handwritten notes or notes on a laptop. Mr Noonan called for the production of those meeting notes.
In answer to a direct question from the Tribunal, Ms Shakespeare said that MSAC members complete conflict of interest declarations when they are appointed, and again, every year and ‘for each meeting item’. She advised that conflicts are managed through the Department’s conflict management team, in liaison with the MSAC chair.
Ms Shakespeare told the Tribunal that the Department provides administrative support to MSAC and to the Pharmaceutical Benefits Advisory Committee, the Prostheses List Advisory Committee, the Stoma Assessment Panel, and a specialised committee that provides advice on the National Epidermolysis Bullosa Scheme. She told the Tribunal that she was one of seven deputy secretaries of the Department, one of whom was designated as the Chief Commonwealth Medical Officer.
In answer to direct questions from the Tribunal, Ms Shakespeare said that ‘hard’ rules have now been published so that submissions made in relation to applications for MSAC consideration that arrive after a deadline will not be put to the Committee. She confirmed that, if these new rules were in place in 2019, the submission made by Dr Suthers would not have been put before MSAC, because it was made only days before the Committee met.
Ms Shakespeare confirmed that MSAC meets in formal session three times a year but can consider matters out of session. It takes three actions in regard to submissions before it: to accept the application; to reject the application; or to defer the application to a subsequent meeting.
Professor Robyn Ward
Professor Ward confirmed that she had made two affidavits that were before the Tribunal.
Professor Ward told the Tribunal that her role as chair of MSAC is to moderate and mediate discussion between Committee members as they consider matters before them, with the agenda for each meeting being set by the Department. Outside the meeting, she said she has a role in moderating contributions by MSAC members and in following up the minutes of the meetings of the Committee.
Professor Ward agreed that the procedures relating to considering submissions made by third parties about applications before MSAC changed from 1 July 2021. She told the Tribunal that the executive of MSAC was given the opportunity to comment on the proposed change but said that the Committee follows the timelines and procedures that the Department puts in place with respect to the ‘oversight’ and operation of the Committee.
Professor Ward told the Tribunal that prior to the strict deadline being put in place for when third party comments could be received, applicants were given opportunities to comment on what came before MSAC. The strict deadline therefore allowed an applicant additional time to respond to comment, “whereas previously comments were coming into the Committee later and, therefore, it didn’t have enough time for further consideration by the applicant”.
Professor Ward agreed that Dr Suthers submitted a document on 26 July 2019, just before the scheduled MSAC meeting on 1 and 2 August 2019, and that it was not disclosed to the Applicant. She said, because of the processes then in place, the Committee was obliged to consider Dr Suthers’ submission, but when asked by Mr Noonan whether the process on this occasion fell short, told the Tribunal that “processes and procedures can always be improved”.
When asked whether MSAC could have deferred consideration of the STA submission because of the late submission by Dr Suthers, Professor Ward said the Committee did not have the power to remove an item from the agenda, only the Department did. She said unless it was removed, it had to be considered.
Professor Ward agreed in evidence that the PSD for STA’s application was more comprehensive than other PSDs because it included a technical section where statistical analysis was included, with the statistical advice being provided by Dr Spelman and another person. Although the two statisticians provided input, Professor Ward emphasised that the content of the PSD is ‘owned’ by the MSAC.
Professor Ward said that MSAC does not vote on applications and operates on the basis of unanimity, with the Committee expressing a collective view through the PSDs. She said “We don’t vote. Everyone needs to agree to the minutes.”
In terms of the process for approval of the PSD, Professor Ward said: “But that’s the process, that the final PSD is sent around to everyone; if anyone has any more comments, they’re asked to comment. If they don’t comment, then that’s approval. But many of them have already commented in advance.”
The Applicant
Mr Montagner gave evidence that his company, STA, is concerned with the commercialisation of health products and that his company helps other companies navigate the health regulatory processes. He told the Tribunal he has 25 years’ experience dealing with assessment panels.
Mr Montagner agreed that he did not get the opportunity to respond to Dr Suthers’ submission to MSAC about the application STA had made, which was being considered at the August 2019 meeting.
Mr Montagner told the Tribunal that STA had made an application (the fifth application) for approval of Oncotype DX in 2017 and thought that they had addressed the matters that Dr Suthers raised in his email to MSAC.
Mr Montagner said that STA had no idea why the sixth application was not approved until he had a meeting with Professor Ward well after the August 2019 meeting.
Dr Hilly put to Mr Montagner that the concerns Dr Suthers raised in his email were not new, as they had been included in a previous PSD. He responded:
Yes, and we thought we had addressed this particular issue. In fact, I’m glad you raised this because as a result of the fifth outcome, we actually noted comments and we were very disappointed et cetera that we - we decided we wouldn’t make a submission, a sixth submission, until we had met with Professor Robyn Ward and the MSAC Secretariat and the department staff to discuss the validity of TAILORx in terms of overcoming this issue and, hence, there were multiple meetings, multiple meetings. There was the critique that Professor Robyn Ward mentioned yesterday that ESC - that Professor Robyn Ward mentioned yesterday and in none of those interactions, zero, and none of the documented publications that were presented to us for response - the documents I’m referring to is the critique and the ESC, the randomisation issue was not raised once. So, we believed that that issue was put to bed by the inclusion of the TAILORx study, which, as I mentioned earlier, was in a landmark study that answered a particular question, and was designed to answer that particular question.
CONSIDERATION
The ‘minutes’
The primary document that the Applicant sought in January 2020 was ‘the minutes of the August 2019 Medical Services Advisory Committee meeting’ in relation to his application. The Concise Oxford Dictionary gives the following definition:
minute (pl.) brief summary of proceedings of assembly, committee, etc.
The Applicant urged the Tribunal to consider the definition of minutes in ss 251A and 253M of the Corporations Act 2001 (Cth). In essence, ‘minutes’ are not defined in that Act but are taken to refer to proceedings, resolutions or members of a company or scheme and – where relevant – declarations of directors.
In her affidavit dated 6 May 2022, Ms Shakespeare stated, beginning at paragraph 71:
71. As outlined at paragraph 50, MSAC minutes and PSDs follow the same format and contain a number of sections. Following the conclusion of the meeting, minutes and the PSD are drafted based on the meeting discussions and the agenda papers and present a succinct and logical account of MSAC deliberations. Minutes are drafted by members of the Secretariat, or on behalf of the Secretariat by contracted medical writers.
72. The MSAC Minutes and PSD are ratified by the full committee.
…
74. Following ratification, a copy of the minutes in the PSD format is provided to the applicant.
(Emphases added)
Ms Shakespeare’s oral evidence at the hearing was that Department officers attend MSAC meetings and take minutes. Subsequently, Dr Hilly told the Tribunal that the ‘actual minutes are taken in the meeting by a contracted report writer for a company. Then what happens is that contracted report writing company puts those together [as] a very rough-cut PSD which is then sent to the Department, so the department never actually receives a copy of those rough-cut notes.’
Dr Hilly then told the Tribunal that it was her instructions that ‘the minutes then become the PSD[s] when they are finally ratified’. The Tribunal said its understanding that what was central to the FOI request made by the Applicant is the minutes of the MSAC meeting of August 2019, which the Tribunal described as the actual ‘to and fro’ of what occurred at the meeting.
When the Tribunal suggested to counsel for the Respondent that there are no minutes, Dr Hilly responded: “No...there are notes, there are these notes that were taken by the contract company, but they are not the same as minutes.”
The Tribunal considers that the administrative processes as revealed in these exchanges were, at least in August 2019, significantly opaque.
The 6 May 2022 affidavit of Ms Shakespeare, a relevant extract of which is above, shifts in its language about ‘minutes’ but it is reasonably clear that paragraph 71 can fairly be read that there are two distinct products produced by the Secretariat with assistance from the medical scribing company after each MSAC meeting. They said to be the minutes of the meeting, which may include the deliberations, and the PSD which emerges as the considered conclusion of the committee in regard to each application it considers. My interpretation is supported by what is said in paragraph 74, which refers to ‘minutes in the PSD format’ being provided to an applicant, making clear that an applicant receives an advance copy of the PSD, not the minutes.
Mr Noonan took Ms Shakespeare to her first affidavit which relevantly stated that:
“Approximately 15 Departmental officers are engaged in governance and secretariat roles that provide advice and support to the committees [that is the five committees this part of the Department supports] including developing and coordinating agenda papers and briefings, taking minutes and making logistical arrangements for meetings.”
The following exchange then took place:
Mr Noonan: So, one of those 15, or one or more of those 15 Departmental Departmental officers would have attended on 1 or 2 August and taking minutes of the meeting?
Ms Shakespeare: Yes.
Mr Noonan: So, do they - - - ?
Ms Shakespeare: It’s not a verbatim records, its minutes.
Mr Noonan: Yes. So, while they’re there, do they record it or do they handwrite it; what’s the process?
Ms Shakespeare: No MSAC meetings are recorded.
Mr Noonan: So, someone’s there taking handwritten notes?
Ms Shakespeare: Maybe handwritten notes or it may be on a laptop.
Professor Ward also referred to ‘minutes’ and said that Committee members agree to them. Subsequently, later submissions were made by counsel for the Respondent that, in fact, there are no minutes per se, and that ‘rough notes’ taken by contracted medical scribes are turned into draft PSDs. These are then sent by the scribing company to the Department for working up by the Department officers and MSAC members, to be the finalised and published PSDs for the applications considered at a meeting.
It would appear that these rough notes are never in possession of the Department. They remain with the contracted medical report writers, and there was no evidence before the Tribunal as to whether they are retained. Professor Ward said she takes her own very brief notes, essentially limited to reminding her who wants to speak on an item, and at the end of the meeting she said she gives her notes to a Department officer to be destroyed. Neither the rough notes from the contractor nor any brief chair’s notes were produced by the Department.
Therefore, the Tribunal has to decide between, on the one hand, affidavit and oral evidence that is inaccurate, or incomplete about the ‘minutes’. Or, on the other, a possibility that a document is being wilfully withheld by the Department. There is no evidence of the latter, so I must conclude the former is the case. In spite of gallant written submissions after the hearing from the Respondent suggesting the Tribunal should accept that the settled PSDs are ‘minutes’, that is not a tenable proposition. It is also not supported by the affidavit evidence.
What troubles the Tribunal is, because it appears that there are no minutes, there would seem to have been no record of who was in attendance at, in this case, the August 2019 MSAC meeting (except for the list of members who were sent the agenda, which may or may not correlate with the members who actually attended all or part of the Committee meeting).
Ms Shakespeare’s evidence is that conflicts of interest are required to be registered by MSAC members annually, but also at each meeting. The Tribunal does not doubt her evidence in this regard, but in the course of usual administrative practice, I would consider that such conflicts of interest would be recorded in formal minutes and, if a particular Committee member had declared a conflict of interest in relation to an agenda item, it would be conventional practice that the minutes would record that the person absented him or herself from discussion for the relevant item.
It was clear from exchanges between the Tribunal and counsel for the Respondent that MSAC meetings do more than discuss applications for funding, leading to PSDs. The MSAC makes decisions for which a PSD is an outcome in relation to a particular application, but it also calls for material in relation to applications and, according to the Department’s own website, has other tasks such as recommending amendments or removal of items on the MBS and advising the Minister on blood and screening products.
As Professor Ward says, it had three functions in relation to submissions: to accept them (with a consequent recommendation to the Minister); to reject them; or to defer them. Professor Ward emphasised that, even if a decision is taken to defer consideration of an applicant’s submission, the particular submission is nonetheless considered first.
The Tribunal accepts Professor Ward’s oral evidence that an important part of the way MSAC operates is that it speaks with one voice when it makes decisions – that it operates, and has historically operated, on the basis of consensus among Committee members. The Tribunal also appreciates that, given the nature of the evaluations that MSAC is required to undertake, it may be undesirable for meeting minutes to record, in particularised form, discussions between Committee members. However, the Tribunal does make the observation that the apparent lack of a proper meeting record (at least in 2019) was not consistent with the norms of good public administration.
To the extent that it was suggested in post-hearing submissions by the Respondent that the PSDs are ‘in effect’ the minutes of the MSAC meeting, the Tribunal does not accept that submission. It is a plainly unsupportable position because it is at odds with the evidence of both Ms Shakespeare and the Committee chair, and with the description of the role of MSAC on its website. It is also at odds with an ordinary understanding of what ‘minutes’ mean. The Tribunal does not need to look at the definition in the Corporations Act urged upon it by the Applicant to be clear in that conclusion.
The PSDs cannot factually be regarded in any way as the ‘minutes’. They are written, as other evidence sets out, as a readable public summary of why a medical service has been recommended or not, and they may include a technical section pitched to readers with relevant knowledge and expertise. It is clear from the Tribunal’s scrutiny of how the PSD was prepared in relation to this particular application by STA, that the PSD includes input from Department officers and, in this case, two consultant statisticians. Accepting Professor Ward’s evidence that the final PSD is ‘owned’ in terms of its final content by the Committee, because of the way it is generated, a PSD axiomatically cannot be considered as a synonym for ‘minutes’.
The Tribunal does not make a finding that the Respondent has been unresponsive in regard to this part of the FOI request. It is apparent on the submissions from the Secretary that no ‘minutes’ exist. I do not necessarily accept the post-hearing submission of the Respondent that the Applicant’s call for the rough meeting notes amounts to an abuse of process or was for a collateral purpose. These ‘notes’ might have shed some light on the deliberations at the meeting. But as they appear not to exist, or at least not to exist in the possession of the agency, I can speculate no more about that.
Dr Suthers’ email of 26 July 2019
Dr Graeme Suthers sent an email to the Department on 26 July 2019. He was aware from the MSAC website, or perhaps the bulletin, that STA’s application was being considered at the MSAC meeting which was to convene five days later. It was clear from the evidence that Dr Suthers’ email was not given to the Applicant before the meeting, although it was included in the voluminous material that was before the MSAC members to inform their discussions.
As mentioned above, in relation to the FOI request, Dr Suthers was contacted by the Department under ss 27 and 27A of the Act and did not object to his email being made available to the Applicant. The Tribunal makes clear that Dr Suthers declared at the outset in his email that he had a conflict of interest because he is a director of a pathology company, Sonic Pathology Australia. The Tribunal attaches no criticism to him in these proceedings.
The Respondent noted that Dr Suthers’ information was released in full to the Applicant. The Respondent, in closing submissions, stated:
…the fact that Dr Suthers’ submission, received late in the piece, was not put to the Applicant reveals no deviation from the MSAC processes in place at that time. Even if a legal obligation of procedural fairness was owed to the Applicant prior to MSAC making a recommendation to the Minister, such an obligation would not necessarily require MSAC an applicant with the opportunity to comment on every piece of material before MSAC. Professor Ward accepted in cross-examination that it was ‘a general rule of practice’ to provide feedback to the applicants and for them to be given the opportunity to comment. But this was a general rule of practice, not an unequivocal rule. The evidence of Professor Ward was that before changes to MSAC’s processes took effect in July 2021, it was ‘always the process to try and provide that opportunity’ (emphasis added). The new changes placed ‘strict guidelines which therefore allowed the applicant time then [to] respond to the comments’…
(Footnotes omitted)
It is clear to the Tribunal that there was a failure of procedural fairness in the fact that the Department did not provide a copy of Dr Suthers’ communication to STA for STA to make any comment. The 2021 change in procedures to set deadlines so that any material submitted by third parties to MSAC can be provided to applicants is a desirable improvement in administrative practice by the Department.
It was, in the Tribunal’s view, a clear breach of the principles of procedural fairness for Dr Suthers’ email not to be given to Mr Montagner at the time. If there was a difficulty in doing that because of the lack of time between his sending the email and the scheduled MSAC meeting, then either the email should not have been included in the papers for Committee members or the consideration of STA’s application should have been deferred, so that the Applicant had an opportunity to address the queries raised. The Tribunal had difficulty in understanding the specific part of the evidence of Professor Ward that STA’s application could not have been deferred unless the Department withdrew it from the agenda. While this may have been the practice, given the other evidence that MSAC can defer consideration of an application, it would seem to me that it was in the power of the Committee to defer on the basis that STA had not seen the Suthers email.
The failure to provide a copy of Dr Suthers’ email to the Applicant is perhaps accentuated by the fact that he is not just, as the Respondent submitted, a member of the public. He is a physician and a director of a pathology company and himself identified that, as a consequence, he had a disclosable conflict of interest in commenting on a medical service being proposed on behalf of another company.
Having said that, the Tribunal notes the Respondent’s submissions that the Applicant accepted in his own evidence that ‘the same issue’ that Dr Suthers was raising had previously been raised with STA by MSAC in the context of the fifth application for Oncotype DX and that Mr Montagner believed the issue had been addressed in the sixth application. Having read all the relevant papers, there is no evidence that would convince me that Dr Suthers’ email was pivotal in the decision MSAC made in relation to STA’s application.
In any event, the Tribunal understands why Mr Montagner felt aggrieved that STA had not seen Dr Suthers’ email before MSAC met in August 2019. The Tribunal also observes that the 2021 changes to administrative procedures should prevent this happening again, as Ms Shakespeare said. Given that the imposition of what were described as ‘hard rules’ was apparently initiated by the Department in consultation with the executive of MSAC, this shows that it was identified as something that needed to be addressed. I would add that it also inclines me to the view that it was realized that the former process lacked procedural fairness. This would tend to undermine the somewhat desultory evidence and submissions at this hearing that defended, or attempted to defend, the former process.
PART 2
TRIBUNAL’S DECISION ON THE DOCUMENTS
In the reviewable decision, as revised, the Respondent maintains claims in the following categories: First, under s 22 of the Act, relating to documents which are edited copies with exempt or irrelevant matter deleted.
Second, under s 47E of the Act: this relates to conditional exemptions where disclosure under the Act could reasonably be expected to (a) prejudice the effectiveness of procedures or methods for the conduct of tests, examinations or audits by an agency; (b) prejudice the attainment of the objects of particular tests, examinations or audits conducted or to be conducted by an agency; (c) have a substantial adverse effect on the management or assessment of personnel by the Commonwealth or by an agency; or (d) have a substantial adverse effect on the proper and efficient conduct of the operations of an agency. Access must generally be given to a conditionally exempt document unless it would be contrary to the public interest. The Tribunal notes that specific submissions were made by the Respondent relating to the particular claimed exemption under s 47E(d) of the Act.
The Tribunal does not accept the submissions of counsel for the Applicant that MSAC is an ‘agency’ for the purpose of the Act. It is a committee established by the Minister in the exercise of executive power, and has no statutory foundation. The relevant agency is the Department. Not a great deal turns on that, because documents relating to the Committee are taken to be documents of the Department, including the PSDs. However, it is relevant that none of the members of MSAC are officers of the agency.
Section 47F of the Act: this relates to personal privacy. A document is conditionally exempt if its disclosure would involve the unreasonable disclosure of personal information.
Section 47C of the Act: this relates to deliberative processes. A document is conditionally exempt if its disclosure would disclose matter which relates to opinion, advice or recommendation obtained, prepared, or recorded, or consultation or deliberation that has taken place in the course of, or for the purposes of, the deliberative processes involved in the function of the agency, in this case the Department. Deliberative matter does not include operational material or purely factual material. Section 47C does not apply to reports of scientific or technical experts, whether employed by the agency or not, expressing opinions on scientific or technical matters.
THE PUBLIC INTEREST
The Applicant’s submissions about the public interest are set out, in summary, above. In response, the Respondent submitted that there is a distinction between the public interest on the one hand, and matters of public interest. The Respondent submitted an extract from Director of Public Prosecutions v Smith [1991] 1 VR 63:
The public interest is a term embracing matters, among others, of standards of human conduct and of the functioning of government and government instrumentalities tacitly accepted and acknowledged to be for the good order of society and for the well being of its members. The interest is therefore the interest of the public as distinct from the interest of an individual or individuals: Sinclair v Mining Warden at Maryborough [1975] HCA 17; (1975) 132 CLR 473, at p. 480, per Barwick CJ There are, as appears to be implicit in the quoted passage of the judgment of Morris LJ in Ellis v Home Office*, several and different features and facets of interest which form the public interest. On the other hand, in the daily affairs of the community events occur which attract public attention. Such events of interest to the public may or may not be ones which are for the benefit of the public; it follows that such form of interest per se is not a facet of the public interest.
*[1953] 2 QB 135, at [147]
The Respondent submitted that the Secretary has not made a ‘class claim’ over any of the information, but has sought to restrict access only to those parts of documents that disclose confidential deliberations or personal information where the disclosure of the information would be unreasonable and, in his submission, contrary to the public interest in terms of the ramifications of that disclosure. The Respondent submitted:
…regard must be given to the nature of the conditional exemptions claimed (in particular, ss 47C and 47E(d)) which are concerned with deliberations and the efficient conduct and operations of an agency. They are focused upon processes and relationships. The harm which is likely to flow from access is a substantial adverse disruption to those deliberations and the efficient conduct and operations of the Department, as well as the relationships between the Commonwealth and those who engage in those processes.
In Part 2 of these Reasons, the Tribunal will briefly refer to the characteristics of each document which remain in contest between the parties. The Tribunal notes that, as it sets out above, there have been three variations of the Original Decision since Mr Montagner lodged his application for review. Each of those variations has been made by the Tribunal at the request of and with the consent of the parties. Each of those variations has resulted in the release of additional documents to the Applicant and the narrowing of claimed exemptions by the Respondent in the remaining documents. Further concessions were made by both parties during the hearing.
The Tribunal has read through all the documents, in unredacted form, and is satisfied, except where stipulated, that the exemption claims, and the conditional exemption claims should be affirmed. In respect of the s 22 exemption claims, they are unremarkable and principally relate to the exemption of irrelevant material, personal email addresses, the names of junior public servants in the Department and the names of persons who work for MSAC members. In respect of the s 47C conditional claims, I am satisfied that they relate to deliberations leading up to the MSAC meeting in August 2019 to equip the Committee to consider STA’s application and, having had the meeting, to then arrive at a recommendation to be made to the Minister. In respect of the s 47E conditional claims, I am satisfied that disclosure of material that individually identifies MSAC members by name or contact details, correspondence between MSAC members and between MSAC members and Department officers and two external consultants would have a substantial adverse impact on the operations of the agency.
It is important to keep in mind that a great deal of the material in contest relates to drafts of the proposed PSD for the Oncotype DX application. The Tribunal’s assessment of this material is that it is unremarkable. It commences with a first draft sent by officers to MSAC members and then the usual back-and-forth exchanges between MSAC members and officers, suggesting additions, amendments, emendments and asking for explanations of particular passages. As is common in such an iterative process where a document is being produced by a Committee with input from a secretariat, some of the drafts have editorial ‘boxes’ or highlighted text where a participant (sometimes an MSAC member, or sometimes an officer of the Department) is making a suggestion or explaining that something has been changed in response to a suggestion on the previous draft. As previously noted, two statisticians were also involved, Dr Spelman and another individual. Some of the material relates to their engagement, and simply has the Department suggesting names of suitable persons who might be able to undertake the statistical task required. It is important to emphasise that the second statistician who sought that his name is not disclosed (an exemption the Tribunal upholds) made the point early on when he was engaged that the reason was that his employing body did not want him (or them) named.
Some of the exemptions sought by the Respondent relate simply to which MSAC member had made a suggestion about one of the drafts of the PSD. The Tribunal accepts the evidence of Professor Ward that the Committee makes decisions on a consensus basis and does not consider that stipulating the identity of different suggestions by Committee members in contributing to a final document is in the public interest. It is the final PSD that is the important document, because it must stand as the Committee’s view.
The Tribunal would go further and say it is satisfied that release of information that could identify individual contributors at the deliberative stage could undermine the work of the Committee. It must be remembered that MSAC is a non-statutory body which was set up in 1998 to provide the Minister with an independent source of advice on whether certain products should receive government funding.
The Applicant’s submissions rightly refer to the fact that MSAC is responsible for making recommendations involving a very substantial amount of public expenditure. But what is intrinsic in its role is that it provides an objective assessment of proposals submitted before it, and then produces a Public Summary Document to explain why it has decided, or not decided, to recommend a particular product for support. Ms Shakespeare’s affidavit and oral evidence properly made clear that MSAC is not the decision-maker on whether the Commonwealth Government will fund a medical service, although she also added that the Minister would be unlikely to decide to fund a medical service where MSAC had not recommended it.
The membership of MSAC is on its website and is publicly known. All the members except for the identified consumer representatives have relevant specialist qualifications and backgrounds – that was not disputed by the Applicant. It is not hyperbole to say that each is eminent in his or her particular field. It is in the public interest that the membership of the Committee be known, and it is certainly in the public interest that anyone can read a PSD, once it has been finalised and after it has been released to an applicant. But I do not accept that public interest extends to access to deliberative processes and drafts. The Respondent distinguished in his submissions between the public interest and matters of public interest and submits that ‘what is interesting to the public and what is in the public interest are two very different things’. I consider that access to the deliberative process in this particular case is neither.
I do consider that, to use the word of the Respondent, some ‘harm’ would result were the deliberative exchanges of the Committee not exempted from release. Earlier in these reasons the Tribunal listed the other committees Ms Shakespeare identified in this particular sector of the Department’s operations. All of them are comprised of persons with relevant backgrounds who are not part of the Department ‘bureaucracy’, but who agree to serve in order to contribute to public policy decisions and, in this case, how public funds are directed.
It is fundamental to the quality of advice the Department is able to provide to the Minister that, in certain areas, outside expertise is drawn upon, and especially so where that expertise includes persons who are practising health professionals. While it would be speculation to accept propositions that persons might quit MSAC if deliberations which identify them are made public, I accept that the knowledge this might potentially occur would be a deterrent to recruitment and to the desirability of joining this Committee or the others named. Relevantly, I note the evidence of Professor Ward that she has been a member of MSAC for around 10 years and it was her experience that it is difficult both to attract people to serve on the Committee, and to retain them. Ms Shakespeare also gave evidence about barriers in recruiting people from a relatively small national pool of suitably qualified specialists. I place weight on this evidence, particularly that of the chair, because of the length of time she has been a member.
During the hearing and in submissions there was debate about which members had raised concerns about individual MSAC members being identified. To the extent that submissions were made to the Tribunal that those who did not should be taken not to have a concern, the Tribunal does not accept those submissions. To the extent that some members had identified to the chair that they would have concerns, the Tribunal accepts those concerns were genuine, while also accepting Mr Noonan’s submission that being concerned did not necessarily amount to considering resignation.
It was suggested in submissions that disclosure of contributions of individual members of MSAC might compromise the ability of the Committee in terms of the quality of independent advice to the Minister. I cannot draw a conclusion on that, except to note that factually successive Commonwealth Governments have relied upon the Committee for 25 years to provide well-considered recommendations, and throughout that time MSAC has acted in a collegiate way.
It is reasonable for me to surmise, because of the background of MSAC members, that they are busy people with high demands on their time and expertise. The basis of them joining a committee to provide professional advice is that the advice is given to the Minister in globo. It is also reflected in Professor Ward’s evidence to the Tribunal that MSAC members do not vote in meetings at all; all decisions are taken by consensus. The Tribunal considers that is also reflected in the consultative way in which the PSDs are drafted and settled after a meeting.
In respect of the names of the ‘discussants’, it was clear from Professor Ward’s evidence that as Chair she would ask some Committee members to take the lead on discussion of certain items. The Tribunal gleaned from her evidence that this was simply to facilitate the flow of discussion at the meeting; the discussants had no other special role in relation to an application listed on the agenda. I note that s 11B(4)(b) of the Act stipulates that it is an irrelevant factor that access to a document could result in a person misinterpreting or misunderstanding the document or (s 11B(4)(d)) could result in confusion or unnecessary debate. These are not factors that I take into account in relation to conditional exemption claim over the ‘discussants’. What I do conclude is that identification of them publicly would have a direct and detrimental effect on the future operations of MSAC and, by extension, this part of the agency. It would undermine the ‘one voice’ nature of how the Committee operates, and has operated since its inception in 1998.
THE DOCUMENTS
The Tribunal accepts the contentions relating to the claims made by the Respondent except where indicated. In those cases, the Tribunal is not satisfied that specific portions of documents should not be disclosed. In relation to the specific s 47E(d) conditional exemption claims, the Tribunal is satisfied for the reasons set out above that it is reasonable to conclude that their disclosure would have a have a substantial adverse effect on the proper and efficient conduct of the operations of an agency, being the Department.
Document 1
These are emails from the Department to members of the Evaluation Subcommittee of MSAC attaching electronic meeting invitations and draft meeting agendas for a meeting of the subcommittee on 13 June 2019. The Respondent noted that information in those documents not relating to the Applicant’s application has been redacted as irrelevant, and that other redactions on these documents include personal email addresses of MSAC members not otherwise publicly available; names and email addresses of persons not employed by the Department providing administrative support to MSAC members; names and email addresses of Department staff who are not of Senior Executive Service (SES) level providing administrative support to MSAC and, in the agendas themselves, the names of particular committee members who were allocated to consider Mr Montagner’s company’s application as ‘discussants’.
The Tribunal affirms the s 22 exemption claims and the conditional exemption claims under s 47E of the Act in relation to the names of the discussants.
Document 2
This document comprises an email cover sheet, and what is described as ‘an updated draft agenda’ for an MSAC ESC meeting in June 2019.
The Tribunal affirms the s 22 claimed exemption and the conditional claimed exemption under s 47E relating to the names of the discussants.
Document 3
This document comprises an email cover sheet and the agenda for the MSAC meeting on 1 and 2 August 2019.
The Tribunal affirms the s 22 exemption claims and the s 47E and s 47F conditional claimed exemption claims.
Document 4
This document comprises an email cover sheet for day 2, and the agenda for the MSAC meeting on 1 and 2 August 2019. Another document is an email dated 26 July 2019 from the MSAC Secretariat.
The Tribunal affirms the s 22 exemption claims and the conditional claimed exemption claims under s 47E of the Act.
Document 5
Document 5 is the email from Dr Suthers to MSAC dated 26 July 2019 with two subsequent emails. The exemption claims relate in the s 22 case to the name of a junior officer, and in the other two cases only to the names of MSAC members who were forwarded the email advising them that the document would be added to the papers for the forthcoming meeting.
The Tribunal affirms the s 22 claim, the s 47E exemption claim, and the s 47F exemption claim.
Document 6
This document is an email to Mr Andrew Mitchell dated 26 July 2019 as well as an article from the European Journal of Cancer
The Tribunal affirms the conditional overlapping claimed exemption claims under s 47C and 47E(d) of the Act.
The Tribunal notes that the journal article from the European Journal of Cancer has been released to the Applicant.
Document 7
This document relates to an email dated 29 July 2019 relating to late agenda papers for the August 2019 MSAC meeting.
The Tribunal affirms the s 22 exemption claims, and the conditional claimed exemption claims under ss 47E and 47F of the Act.
Document 8
This is correspondence between the Department and MSAC members in the lead up to the MSAC meeting on 1 August 2019. One of the MSAC members asks for the Clinical Study Report for the TAILORx trial and is advised by the Department that neither the Applicant nor the sponsor (Genomic Health Inc) have a copy of the Clinical Study Report.
The Tribunal affirms the s 22 exemption claims and the conditional claimed exemption claims under s 47F of the Act.
Document 9
This is a 30 July 2019 email from the Department to MSAC members forwarding correspondence between STA and the Department regarding the Clinical Study Report for the TAILORx trial. It includes another email from an MSAC member referring to a journal article and an article from the 20 June 2019 issue of The New England Journal of Medicine, which has been released to the Applicant. Also included are what appear to be slides to be used by the discussant for an MSAC meeting.
The Tribunal affirms the claimed exemption under s 22 and the conditional claimed exemption claims under ss 47C and 47E(d) of the Act.
Document 10
This is a text message between an MSAC member and Mr Mitchell seeking a discussion before the MSAC meeting.
The Tribunal affirms the s 22 exemption claims and the conditional exemption claims under s 47E of the Act.
Document 11
This is correspondence between MSAC members, and between MSAC members and the Department, regarding an early draft of the PSD for application 1342.5.
The Tribunal affirms the s 47E conditional exemption claim.
Document 12
This is correspondence among MSAC members and between MSAC members and the Department regarding what the Respondent describes as ‘a further draft of the MSAC minutes/PSD’. It also includes draft correspondence from the MSAC chair. This document includes material relating to another application, names and emails of officers and comments on deliberations.
The Tribunal affirms the s 22 exemption claims, the s 47E conditional exemption claims and one conditional exemption claim under s 47F.
Document 13
This document is no longer in issue between the parties.
Document 14
This document is an email dated 9 September 2019 to the MSAC Secretariat. The material sought to be exempted relates to names, email addresses and other applications. The document also includes editorial comments on different parts of the draft PSD which are in the manner of a working draft, along the lines of suggestions for expanding paragraphs or providing more details, or querying what particular passages mean. It is clear to the Tribunal that this is a routine document where there are a number of contributing authors making different remarks along the pathway to a finalised draft.
The Tribunal affirms the s 22 exemption claims and the conditional claimed exemption under s 47E of the Act.
Document 15
This is an email from the MSAC Secretariat dated 12 September 2019 sending draft PSDs to an MSAC committee member for comments, and including ‘marked up’ comments on the draft text.
The Tribunal affirms the conditional exemption claims under s 47E and one conditional exemption claim under s 47F of the Act.
In regard to the s 22 exemption claims, the Tribunal affirms those claims except for the claim to exempt the first eleven words in the second paragraph of the email, which the Tribunal does not exempt from disclosure.
Document 16
This is email correspondence between Mr Mitchell and an MSAC member of various dates in November and October 2019. These documents include correspondence among MSAC members and between MSAC members and the Department regarding a further draft PSD, attaching copies of those further drafts with various marked up comments and corrections.
The Tribunal affirms the exemption claims under s 22 and the conditional exemption claims under s 47E of the Act.
Document 17
This is an email dated 17 November 2019 from Mr Mitchell of the Department and a reply.
The Tribunal affirms the conditional claimed exemptions under s 47E and one claimed exemption under s 47F of the Act relating to the name of an external person.
Document 18
This is an email from Mr Mitchell to an MSAC member with what he describes as a ‘clean’ version of the draft PSD. It also includes an article from The Lancet which has been provided to the Applicant.
The Tribunal affirms the claimed s 22 exemptions, and the claimed conditional exemptions under ss 47E and 47F of the Act.
Document 19
This is correspondence among MSAC members, and between MSAC members and the Department, regarding a further draft PSD, including correspondence from third party consultants who performed a statistical review of MSAC’s statistical methods and analysis to ensure that it was properly addressed to a technical audience, and several versions of a draft PSD.
The Tribunal affirms the s 22 exemption claims, the s 47E conditional exemption claims and the s 47F exemption claims relating to the identity of one of the consultants.
Document 20
This is correspondence between the Department and MSAC members about the ratification of the draft PSD.
The Tribunal affirms the s 22 exemption claims and the s 47F exemption claims. It affirms the s 47E exemption claims except for the claimed exemption under s 47E(d) in relation to the last sentence of the 10 January 2020 email. That sentence is to be disclosed to the Applicant.
Document 21
This is email correspondence from Mr Mitchell to an MSAC member discussing the contents of the PSD and email correspondence from the consultant statistician to Mr Mitchell. It includes a statistical review of the Oncotype DX application which has been provided to the Applicant with the name of the author redacted.
The Tribunal affirms the s 22 exemption claims, and the conditional claimed exemptions under ss 47E and 47F of the Act.
Document 22
This is email correspondence from an MSAC member to Mr Mitchell and others relating to assistance with a ‘lay summary of an MSAC outcome’ and subsequent exchanges.
The Tribunal affirms the s 22 exemption claims, and the conditional claimed exemptions under s 47E of the Act, and two conditional claimed exemptions in relation to identifying a person under s 47F of the Act.
Document 23
This a 21 January 2020 email from Mr Mitchell to the MSAC Secretariat and other persons titled “Re: MSAC Outcome for 1342.5 – seeking advice on next steps”, together with various comments about the release of the PSD.
The Tribunal affirms the s 22 claimed exemptions, the s 47E conditional exemption claims and two s 47F conditional exemption claims relating to the identity of an individual.
PART 3
SUMMATION
The Tribunal has read all the documents in full, where exemptions are claimed. It is satisfied that there was no irregularity disclosed about the administrative process followed by MSAC and accepts the proposition put by Dr Hilly on behalf of the Secretary that, were the internal exchanges between MSAC members and MSAC members to staff of the Department to be disclosed, either to an applicant or generally, it would have a fundamental and detrimental effect on the efficient operation of the Committee. As mentioned above, the Tribunal cannot say whether, as was suggested during the hearing, it might lead to the resignation of committee members, but it may well deter persons from agreeing to serve on the Committee.
The Applicant’s counsel acknowledged that the work of MSAC is important and accepted that it took up time to be on the Committee. The Tribunal considers that the time spent in the hearing on discussing the changes made by the Remuneration Tribunal to allowances for MSAC members was otiose. The Tribunal in particular, rejects any submission, directly or by inference made, that the increase in the sitting fees as decided by the Remuneration Tribunal would influence retention or recruitment to the MSAC.
However, as these reasons set out earlier, there were two particular points that emerged from the hearing that illustrated room for improvement in terms of the administration by the Department and support for MSAC. The first of these has apparently been addressed, by the imposition of deadlines for third party comments on applications to be considered by the Committee. The second is the apparent absence of minutes of MSAC meetings, in spite of various evidence suggesting that minutes are produced. That is a deficiency which, for the reasons set out earlier, the incoming Secretary of the Department may care to address.
In making that suggestion, the Tribunal makes clear that there was no evidence of any irregular practice in the way the Committee dealt with this application (save for the regrettable inclusion by the Department in the meeting papers of Dr Suthers’ email which I consider was procedurally unfair). However, some record of MSAC meetings that set out the members present, who had declared conflicts of interest for particular items, what was discussed (in general, not in terms of who said what about individual applications) and what other matters were discussed, can only be an improvement.
The Tribunal has carefully considered the detailed and thoughtful submissions put forward by the parties in this matter. The Tribunal accepts that the driver of the Applicant’s request for the documents under the Act and his subsequent request for review by the Tribunal was frustration and, perhaps, an element of perplexity about the fact that STA’s sixth application had been rejected. That came through in his candid evidence, and is entirely understandable.
However, the Tribunal notes that the tenor of Professor Ward’s oral evidence was that the Oncotype DX application was not one lacking in merit, which is why so much time was spent not only on the writing of the PSD but the additional steps that were taken after the August 2019 meeting in holding face to face meetings with the Applicant. From that, the Tribunal makes the gratuitous observation that it hopes Mr Montagner will not abandon his quest for approval of this product. It would seem to be well worth pursuing, given that the evidence is that it, or a very similar product, is prescribable in North America and certain countries in Europe.
DECISION
Pursuant to s 43(1)(b) of the AAT Act, the Tribunal varies the reviewable decision, as amended by the Tribunal under s 26(1)(b) of the AAT Act, in the terms set out in Part 2 of the Reasons for Decision above.
I certify that the preceding 193 (one hundred and ninety-three) paragraphs are a true copy of the reasons for the decision herein of Senior Member D. J. Morris
..........................[sgd]........................
Associate
Dated: 25 May 2023
Date(s) of hearing: 6 June 2022, 8 and 9 August 2022 Date final submissions received: 19 October 2022 Counsel for the Applicant: Mr Patrick Noonan Solicitors for the Applicant: FCG Legal Counsel for the Respondent: Dr Laura Hilly Solicitors for the Respondent: The Australian Government Solicitor
Key Legal Topics
Areas of Law
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Administrative Law
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Statutory Interpretation
Legal Concepts
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Procedural Fairness
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Judicial Review
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Standing
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Remedies
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Jurisdiction
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