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Tuesday, June 01, 2010

Drug secrecy law trumps FOI

An Administrative Appeals Tribunal decision involving an application for documents concerning the listing of the drug Strattera on the Commonwealth Government Pharmaceutical Benefits Scheme, while unremarkable in terms of the law and its interpretation and application, raises several important issues. For example the interplay between secrecy provisions in other acts and the Freedom of Information Act; how the ground can shift to exemption arguments in the AAT that haven't been raised in earlier processing of the application; and how information relevant to public health is protected from disclosure by laws that don't require showing harm from disclosure - "the law says" is enough although the Australian Law Reform Commission has recommended changes. Finally while the usual situation is for the applicant for documents who takes a matter to the AAT to end up with what he/she had before proceedings started, at least, and hopefully a little or a lot more, in this case the applicant ended up worse off-even documents the Department had agreed to release were found to be exempt.

Martin Whitely an ALP Member of state parliament in Western Australia, and a parliamentary secretary in the previous government sought access under the Freedom of Information Act to documents held by the Pharmaceutical Benefits Advisory Committee about the listing of Strattera on the Pharmaceutical Benefits Scheme. One of Mr Whitely's campaigns since election in 2001 has been mistakes in diagnosis of attention deficit disorder, overuse of prescription drugs to treat the condition and their side effects. Strattera has attracted attention in this regard.
After consultations with the manufacturer Eli Lilly, and an internal review, the Department had decided to release two documents in full, to release parts of seven others and to claim two documents wholly exempt. The exemptions cited were section 43 (business affairs) and section 45 (information obtained in confidence).  Lilly prior to the internal review had objected to disclosure of 8 of the 9 documents the Department had been prepared to release in full or in part. It did not object to release of one document, the Public Summary Document for Atomoxetine from a November 2006 Pharmaceutical Benefits Advisory Committee meeting.

Lilly at this stage indicated it would not be exercising its further appeal rights but Mr Whitely, still dissatisfied, took the matter to the Tribunal.In Whitely and Department of Health and Ageing[2010] AATA 338 the Tribunal was presented with an additional and compelling argument for refusal of access to all 11 documents in their entirety: the documents were exempt under section 38 of the act because disclosure was an offence under section 135A of the National Health Act, a provision listed in Schedule 3 of the FOI act. No other considerations are relevant. Secrecy provisions listed in schedule 3 of the FOI act in effect trump FOI rights of access. The Tribunal agreed, noting it had no power to grant access to the documents.

Perhaps the Department of Health knew all along that this was the case, preferring to rely on ss 43 and 45 and not section 38 in refusing access because the FOI Guidelines—Exemption Sections in the FOI Act (FOI Exemption Guidelines)- prepared by the Australian Government Solicitor, express the policy position:
9.1.4 Section 38 should be used only where truly necessary, lest it become a means of exempting information more appropriately considered, for example, under ss 41, 43 or 45 of the Act.
In the AAT, government policy notwithstanding, the Tribunal's role is to make the correct or preferable decision. Lawyers acting for the Department now ran section 38 up and bingo. While Whitely had a chance to argue public interest in disclosure to a degree if the business affairs exemption was in the frame, he had no chance if s 38 was found to be relevant.This hadn't been a consideration when the AAT proceedings were initiated.

Section 135A of the National Health Act is one of more than 65 secrecy provisions from over 28 Acts and one sub-regulation listed in schedule 3 of the FOI act. In its recent report Secrecy Laws and Open Government in Australia, the Australian Law Reform Commission also identified four provisions in other acts that expressly apply s 38 that are not listed.

Section 135A, like hundreds of secrecy provisions in Commonwealth acts has no harm from disclosure element. It reads:
(1) A person shall not, directly or indirectly, except in the performance of duties, or in the exercise of powers or functions, under this Act or for the purpose of enabling a person to perform functions under the Medicare Australia Act 1973 or the medical indemnity legislation, and while the person is, or after the person ceases to be, an officer, divulge or communicate to any person, any information with respect to the affairs of a third person acquired by the first-mentioned person in the performance of duties, or in the exercise of powers or functions, under this Act.
Penalty:  $5,000 or imprisonment for 2 years, or both.

The ALRC recommended wholesale reconsideration of all 506 secrecy provisions on the statute book, and that provisions such as s 135A should only be warranted where linked to an express harm from disclosure: "where they are necessary and proportionate to the protection of essential public interests of sufficient importance to justify criminal sanctions."  The Government has yet to respond to the report completed last December.

Section 38 and schedule 3 didn't rate mention or action in the recent FOI reform debates. Over to the comprehensive review of the act due in two years or so...

Meanwhile documents requested by Mr Whitely remain safe and secure at the Department and with Eli Lilly:
  • All documents provided to the PBAC in their determination that Strattera® should be placed on the PBS.
  • Documentation outlining specific consideration given by the PBAC regarding Strattera’s black box warnings for suicidal ideation.

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