PharmaDispatch received a photograph of the now infamous ‘Vancouver poster’ on 5 June.
The research, 'Securing access to medicines using discounts in Australia', was presented as a poster at the HTAi 2018 Meeting in Vancouver.
The poster included a table presenting the median discount negotiated under PBS special pricing arrangements across several ATC groups.
Special pricing arrangements are confidential under deeds of agreement negotiated between pharmaceutical companies and the government.
Companies maintain that allowing access to the deeds of agreement and the use of confidential information they contain breached the terms of what are legally binding contracts.
It was subsequently revealed the confidential information was also used as the basis for a paper published in 2017. The paper, 'Characteristics of Managed Entry Agreements in Australia', was published online in the International Journal of Technology Assessment.
PharmaDispatch published the first story on the issue on 6 June. A series of stories were published over subsequent days.
In its initial response to the issue, provided on 6 June to questions submitted by PharmaDispatch on 5 June, the Department of Health said it approved access to the confidential information to the “lead researcher only, as a departmental employee, on the basis that rebates applying to individual medicines and effective prices of medicines were not published.”
Lawyers representing companies wrote to the Department of Health and other relevant parties, including the publisher of PharmaDispatch, demanding certain undertakings in relation to the research and access to the confidential information contained in deeds of agreement.
The Australian Government Solicitor subsequently responded confirming no further disclosure of the confidential information would occur and that copies of the 'Vancouver poster' had been recalled and destroyed.
Health minister Greg Hunt made a public statement on 15 June, saying the Department had advised “they have taken steps to put a hold on any further disclosure.”
The Australian Government Solicitor wrote to companies on 3 July saying the Department of Health had not breached the confidentiality provisions of deeds of agreement.
Freedom of Information request
PharmaDispatch submitted a freedom of information (FoI) request to the Department of Health on 7 June.
The FoI covered an extended period, from March 2015 to June 2018, and sought access to all documents relating to the decision to grant Maxine Freeman-Robinson (‘researcher’) access to confidential company pricing information covered by special pricing arrangements.
The Department of Health acknowledged receipt of the request on 12 June. After further discussions between the Department and Daily Dispatch, the publisher of PharmaDispatch, the scope and wording of the FoI was finalised on 20 June.
The Department emailed Daily Dispatch on 4 July notifying the publisher of its intention to conduct third-party consultation.
“It appears, from the documents to which you seek access, that a third party may reasonably wish to make a contention concerning possible exemption of some of the documents,” it said.
It did not disclose the identity of the party or parties to be consulted but based on the subsequent ‘notice of decision’ it could include the researcher and other current non-employees of the Department of Health.
This was essentially confirmed on 12 July when Daily Dispatch received correspondence from lawyers representing a third party and one of the people listed as an author of the research.
The correspondence accused this publication of making “false and defamatory statements” in relation to the issue and demanded a published apology, retraction and the removal of all related content from the PharmaDispatch site.
Lawyers representing this publication responded to the demands on 3 August. Readers will see the relevant articles remain online and the absence of any apology or retraction.
Daily Dispatch received further correspondence on the FoI request from the Department of Health on 18 July. This correspondence confirmed the cost of the FoI. Daily Dispatch paid the required deposit. The correspondence also restated the requirement for third-party consultation.
Daily Dispatch received a ‘Notice of Decision’ on the FoI on 14 August. It confirmed the Department had identified eight documents falling within the FoI request. The Department exempted five in total, meaning they would not be released, but said three would be released with ‘exemptions applied’.
Daily Dispatch paid the outstanding charge associated with the FoI on 15 August and received the related documents on 16 August.
What the documents reveal
4 June 2015 – Email exchange on potential research
The researcher submitted the initial request regarding their proposed PhD research project on 4 June 2015 – around five months before their return to the Department of Health as a ‘non-ongoing casual employee’.
It appears the request was made via email directly to an assistant secretary in the Department’s Pharmaceutical Benefits Division rather than through its formal data request process.
The initial request acknowledged potential confidentiality issues and explicitly excluded anything on “actual price”. According to the email, the research only required confirmation that a special pricing arrangement existed, which is publicly available in the PBS schedule.
“The focus of the research is to link the decision with the existence of a deed and the (sic) describe how the deed operates…The operation of each deed is not required as the formulas can be described in general terms under a classification system,” said the researcher in their initial request.
Importantly, the email of 4 June included reference to a third-party. The third-party is not identified but the Department’s ‘notice of decision’ confirms it is a reference to “individual employees outside Government employment” and “they would not expect to be made public in this context.”
29 and 30 June 2015 – Follow-up email
The researcher sent a follow-up email to the same assistant secretary on 29 June. A subsequent exchange on 30 June has been excluded under legal professional privilege, which means it relates to legal advice.
2 September 2015 – Handwritten file note
One of the documents exempted is the researcher’s “Handwritten file note”, created on 2 September 2015, of a meeting they had with the assistant secretary and a Department of Health lawyer.
The subject of the meeting is not disclosed because the document has been exempted under legal professional privilege.
According to the notice of decision, the claim of legal professional privilege is based on the fact the “communications were for the dominant purpose of receiving legal advice.”
“The legal adviser concerned was at all times a practising lawyer and acting in a capacity as a professional and independent legal adviser within the Department’s in-house legal branch. Advice was sought and provided on a confidential basis within this professional capacity from the relationship of a lawyer to a client,” says the notice of decision.
It seems the Department of Health in-house legal adviser was providing advice to a non-employee. The substance of that advice remains unclear but, given it falls within the scope of the FoI, it must relate to the researcher’s request to access the relevant documents containing confidential company pricing information.
13 October 2015 – Approval to be APS employee
The researcher emailed the then director of Post-Market Review, in the Department’s Pharmaceutical Benefits Branch, on 13 October. The email is titled ‘Minute seeking approval for me to be APS employee’.
Only the sender, recipient and title are known because the entire document has been exempted from release. The reasons for this exemption include legal professional privilege, meaning the content relates to legal advice provided on accessing the documents with the confidential information, and ‘personal privacy’.
As previously discussed, the Department’s notice of decision confirms ‘personal privacy’ is a reference to “individual employees outside Government employment”. This could relate to the researchers or other people.
28 October 2015 – Employment to ‘facilitate access’ to documents
The director of Post-Market Review sent a Minute to the assistant secretary on 28 October titled ‘Employment of a non-ongoing casual employee’.
The reference to non-ongoing means the researcher was engaged for less than 12 months.
The document has been released but does include significant exemptions.
Importantly, the Minute confirms a primary factor in their employment was to “facilitate access” to the confidential pricing information.
It says the researcher is undertaking an “extensive review” of the effectiveness of risk sharing arrangements as part of her PhD.
“It is my view that a review of the Risk Sharing Arrangements would be of benefit to the Department and the Government,” says the minute.
It continues, “…the workload is extensive and many of the documents contain some commercially sensitive information. To have this work undertaken by a contractor would be problematic given the scope and content of the material required for such a review. Ms Freeman-Robinson has extensive experience in this area and will be able to identify and extract information, prepare a detailed report for the Department that addresses issues of confidentiality and commercial sensitivity, at the same time as completing her PhD research.”
It concludes, “In my view the Department will gain the benefit of a comprehensive and useful report at no additional cost.”
Based on a response previously provided, the researcher “recommenced employment with the department on 1 November 2015.”
30 November and 7 December 2015 – Access to the documents
Two subsequent documents reveal the researcher was involved in the process for approving their access to the documents containing the confidential pricing information. They may have even had a significant role in drafting the advice approving their access.
Both documents, dated 30 November and 7 December respectively, have been exempted from release.
The first is an email from the researcher to a departmental in-house legal adviser.
The second email, also from the researcher to a departmental in-house legal adviser, has the far more revealing title ‘Minute_approve access to documents including draft minute’. The title suggests the researcher played a significant role in drafting the minute approving their access to the confidential pricing information.
11 January 2016 – Legal adviser replies
The legal adviser replies to the director of Post Market Review on 11 January 2016. The email is exempted from release but has the title ‘Lex 23912 - public interest disclosure of information for PHD research’.
1 February 2016 – The approval
The final document is arguably the most significant.
It is a minute from the director of Post Market Review to the acting assistant secretary of the Pharmaceutical Evaluation Branch. It has the title ‘Minute: Approve access to documents for research’.
It has been exempted for release on the basis of ‘secrecy’.
The minute has the rationale for allowing the researcher to access the documents containing confidential company information. It has been exempted because the researcher is a third-party and its release would not be in the public interest.
It seems allowing a researcher to access confidential pricing information was in the public interest but disclosing the reason why is not.
The Department of Health has defended its decision to allow the researcher to access the documents because they were an employee at the “relevant” time. However, they seem to now be exempting this key document from public release partly on the basis the researcher is longer an employee – even though it relates to the performance of her duties as an employee.