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'E' and Department of Health and Ageing [2013] AICmr 14 (28 February 2013)

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Decision and reasons for decision of Acting Freedom of Information Commissioner, Toni Pirani

Summary of case details
Applicant:

'E'

Respondent: Department of Health and Ageing
Other parties: Anonymous
Decision date: 28 February 2013
Application number: MR11/00127
Catchwords:

Freedom of information — Whether giving access would disclose information that would reasonably be regarded as irrelevant to the request — Request for information about identity and qualifications of clinical assessor — Whether disclosure of personal information unreasonable — (CTH) Freedom of Information Act 1982 ss 22, 47F(1)

  Contents

 Summary

  1. I set aside the decision of the Department of Health and Ageing (the Department) of 29 March 2011 and substitute my decision, under ss 11A(5), 22 and 47F of the Freedom of Information Act 1982 (the FOI Act), refusing access to some of the documents sought and granting access to others, some modified by deletions.

 Background

  1. The Therapeutic Goods Administration (TGA), a division of the Department, is responsible for regulating therapeutic goods, such as medical devices, in Australia. Before a medical device can lawfully be supplied in Australia it must be included on the Australian Register of Therapeutic Goods (the Register). The TGA is responsible for assessing therapeutic goods for inclusion on the Register, as well as the post-market monitoring and enforcement of standards for these goods.
  2. The applicant has two medical devices included on the Register. In July 2010, the applicant provided an expert report to the TGA in support of the therapeutic claims being made about the applicant's devices. The expert report provided by the applicant was reviewed by a TGA medical officer who prepared a clinical assessment report on the veracity of the applicant's evidence.
  3. On 21 December 2010, the applicant's legal representative made a request under the FOI Act to the Department for access to:

    [i]nformation about the identity and qualifications of the clinical assessor who reviewed our client's expert report. Specifically, we seek a copy of the clinical assessor's curriculum vitae and, in particular, information about the clinical assessor's expertise and experience in the field of magnetotherapy.

  4. The Department undertook a search for the documents requested and did not locate a copy of the assessor's curriculum vitae. However, the following documents were identified:
    • a copy of the assessor's university degree for Bachelor of Medicine and Bachelor of Surgery
    • a copy of the assessor's certificate of provisional registration as a medical practitioner
    • a copy of the assessor's certificate of registration as a medical practitioner
    • a copy of the personal details page of the assessor's passport.
  5. On 29 March 2011, the Department advised the applicant's legal representative that it had understood the scope of the request to be for the curriculum vitae of the clinical assessor only and that it was refusing the applicant's request on the basis that the documents sought by the applicant could not be found or do not exist.
  6. On 23 May 2011, the applicant sought Information Commissioner (IC) review of this decision under s 54L of the FOI Act.
  7. On 3 August 2011, the Department advised this office that, following additional searches, a copy of the assessor's curriculum vitae had been found. The Department submitted that this document should not be released to the applicant as it would involve an unreasonable disclosure of personal information.

 Decision under review

  1. The decision under review is the decision of the Department of 29 March 2011 to refuse the applicant access to the documents sought.

 Irrelevant information (s 22)

  1. The Department contends that the copy of the assessor's passport is irrelevant to the scope of the applicant's request.
  2. I have reviewed the document in question and I agree with the Department that the assessor's passport is irrelevant to the scope of the applicant's request because 'it neither relates to the person's qualifications as an assessor nor identifies the person as the assessor who undertook the clinical assessment of the company's medical devices'.
  3. Even if this information was considered relevant to the applicant's request, it is likely it would be found conditionally exempt as it contains personal information about the assessor that was not included as part of the assessor's usual duties or responsibilities with the Department.

 Personal privacy exemption (s 47F)

  1. The Department contends that the remaining four documents are conditionally exempt under s 47F(1) (personal privacy) as they contain personal information that it is unreasonable to disclose.
  2. Section 47F(1) of the FOI Act provides:

    47F Public interest conditional exemptions -personal privacy

    General rule

    1. A document is conditionally exempt if its disclosure under this Act would involve the unreasonable disclosure of personal information about any person (including a deceased person).
  3. Section 4 of the FOI Act provides that personal information means 'information or an opinion (including information forming part of a database), whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion'.
  4. The Australian Information Commissioner has issued Guidelines under s 93A to which regard must be had for the purposes of performing a function, or exercising a power, under the FOI Act. The Guidelines explain that:

    [d]ocuments held by agencies or ministers often include personal information about public servants. For example, a document may include a public servant's name, work email address, position or title, contact details, decisions or opinions.

    Where public servants' personal information is included in a document because of their usual duties or responsibilities, it would not be unreasonable to disclose unless special circumstances existed. This is because the information would reveal only that the public servant was performing their public duties.[1]

  5. The documents sought contain the name, address, educational qualifications and employment history of the clinical assessor. This information is 'personal information'.
  6. The Department argued that the disclosure of the four documents would be unreasonable for the following reasons:
    • the documents were not created as a result of the assessor performing his or her usual duties or responsibilities
    • even if the assessor's name was redacted from the documents, it would still be possible to ascertain the assessor's identity through an internet search, and
    • the disclosure of assessors' names generally may result in undue influence being applied to persons undertaking assessments.
  7. The applicant argues that, even if it were considered unreasonable to disclose these documents because they contain personal information, it is not unreasonable to disclose the identity of the clinical assessor where this information was included as part of their normal duties in preparing the clinical assessment report.
  8. I think that the statutory framework under which a post-market review of medical devices included in the Register is undertaken is relevant to this matter and goes to the issue of whether it would be unreasonable to disclose the identity of the clinical assessor.
  9. The Therapeutic Goods Act 1989 (the Act) and Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations) set out a statutory framework under which products are assessed for inclusion on the Register and their ongoing compliance with the Essential Principles is reviewed. The Essential Principles are stated in Schedule 1 of the Regulations and set out the requirements relating to the safety and performance characteristics of medical devices.
  10. When undertaking a post-market review of a product, the role of a TGA clinical assessor is to consider, analyse and assess the quality of the evidence provided by the sponsor of the product. The assessor then prepares a report to the delegate of the Secretary of the Department, which provides an assessment of whether the evidence provided by the sponsor supports the claims being made about the product and provides recommendations on whether there is sufficient evidence that the device complies with the Essential Principles.
  11. In completing this role, the assessor is essentially undertaking a peer review role of the evidence provided by the sponsor of the medical device, but is not exercising any delegated statutory power and cannot make a decision to cancel a medical device from the Register. This power may only be exercised by either the Secretary or delegate.[2]
  12. In light of this statutory framework, in particular the role of the clinical assessor in the review process, I think that the disclosure of the personal information of the clinical assessor would be unreasonable in this instance.
  13. I consider that the assessor's curriculum vitae is conditionally exempt in its entirety due to the nature and extent of personal information it contains; for example, the clinical assessor's full name, personal phone number, birth date and detailed employment history.
  14. However, I consider that the qualification documents of the assessor could be edited to remove personal information, such as the clinical assessor's name, whilst still providing the applicant with information regarding the assessor's qualifications. I do not think it would be unreasonable to release the qualification documents of the assessor with identifying information redacted.

 Findings

  1. I find that the four documents that contain the personal information of the assessor are conditionally exempt under s 47F. If exempt, it will not be reasonably practical for the Department to provide the applicant with an edited copy of the curriculum vitae, having regard to the extent of modifications that would be required. However, if exempt, edited copies of the assessor's qualifications could be provided to the applicant under s 22.

 The public interest test (s 11A(5))

  1. I have found that four of the five documents subject to this IC review are conditionally exempt. Section 11A(5) of the FOI Act provides that, if a document is conditionally exempt, it must be disclosed 'unless (in the circumstances) access to the document at that time would, on balance, be contrary to the public interest'.
  2. As the Guidelines explain, '[t]he pro-disclosure principle declared in the objects of the FOI Act is given specific effect in the public interest test, as the test is weighted towards disclosure'.[3]
  3. The primary factor favouring disclosure in s 11B(3) is the promotion of the objects of the FOI Act, including enhancing the scrutiny of government decision making. However, in this case, the applicant already has the assessment report and the identity of the delegate who issued the notice of proposal to cancel the device from the Register. This has provided the applicant with the necessary information to scrutinise the decision making and contest the notice. For this reason, I do not give much weight to this factor.
  4. Against this factor must be balanced the factors against disclosure. The FOI Act does not specify any factors against disclosure, but the Guidelines include a non-exhaustive list of such factors.[4] Of those factors listed in the Guidelines, the ones relevant to this IC review are that disclosure:
    • could reasonably be expected to prejudice the protection of an individual's right to privacy and
    • could reasonably be expected to prejudice the management function of an agency.
  5. I do not consider there to be a public interest in the applicant knowing the identity of the clinical assessor. Release of the information could reasonably be expected to prejudice the assessor's right to privacy. The clinical assessor did not make the decision to propose to cancel the applicant's medical device from the Register; this decision was made by the delegate of the Secretary who was under no obligation to accept the findings or recommendations of the clinical assessor when making a final decision.
  6. I also consider that release of identifying information about the assessor could reasonably be expected to prejudice the management function of the Department. The Department submitted, and I accept, that disclosing the identity of those involved in preparing clinical assessment reports would be detrimental to the operations of the TGA by exposing assessors to undue influence or pressure from device sponsors and making it more difficult for the TGA to recruit and retain qualified assessors.
  7. In balancing these factors for and against disclosure, I think that the factors against disclosure should be weighted heavily in this case and I find that, for the reasons stated above, the disclosure of the information could reasonably be expected to prejudice the protection of the clinical assessor's right to privacy and the management functions of the Department in undertaking independent reviews of medical devices.

 Findings

  1. Giving the applicant access to the four documents that I have found to be conditionally exempt under s 47F would, on balance, be contrary to the public interest for the purposes of s 11A(5). However, edited copies of three of those documents could be provided to the applicant under s 22.

 Decision

  1. Under s 55K of the FOI Act, I set aside the Department's decision of 29 March 2011 and decide, in substitution for that decision, that the documents sought by the applicant do exist.
  2. Of the five documents considered in this IC review, I find that:
    • one document (the copy of the assessor's passport) is irrelevant under s 22
    • one document (the assessor's curriculum vitae) is exempt in full under s 47F, and
    • three documents (the assessor's university degree, certificate of provisional registration as a medical practitioner and certificate of registration as a medical practitioner) are exempt in part under s 47F. These documents should be provided to the applicant, edited under s 22 to remove identifying information: the clinical assessor's name, and the dates and numbers of the documents.

Toni Pirani
Acting Freedom of Information Commissioner

28 February 2013

Review rights

If a party to an IC review is unsatisfied with an IC review decision, they may apply under s 57A of the FOI Act to have the decision reviewed by the Administrative Appeals Tribunal. The AAT provides independent merits review of administrative decisions and has power to set aside, vary, or affirm an IC review decision.

An application to the AAT must be made within 28 days of the day on which the applicant is given the IC review decision (s 29(2) of the Administrative Appeals Tribunal Act 1975). An application fee may be payable when lodging an application for review to the AAT. The current application fee is $816, which may be reduced or may not apply in certain circumstances. Further information is available on the AAT's website (www.aat.gov.au) or by telephoning 1300 366 700.


[1] Office of the Australian Information Commissioner,Guidelines issued by the Australian Information Commissioner under s 93A of the Freedom of Information Act 1982 [6.138–139].

[2] Section 41GN of the Therapeutic Goods Act 1989.

[3] Guidelines [6.12].

[4] Guidelines [6.29].