3.1  Managing and assessing confidential material

3.1.1   Material contained in submissions

Australian Government Department of Health

Electronic and paper-based records are maintained by the department to show what happened, when and how it happened, who was involved, what was decided or recommended, what advice or instruction was given, and the order of decisions or events. The department maintains policies and procedures to ensure the management and storage of records is consistent, accurate and appropriate.

Submissions to the PBAC should be made through the Health Products Portal (HPP).  The contents of all submissions and any correspondence received post submission lodgement are stored in the department’s IT system as provided by the applicant.

Access to the contents of the submission is limited to officers who need to work on the submission material. Access is controlled by senior officers in OHTA.

The contents of submissions are potentially subject to release under Freedom of Information legislation and may also be subject to requests of the Parliament.

For information regarding the HPP terms of use, please see HPP terms and conditions.

Contractors evaluating submissions and working on agenda items for the PBAC

The external evaluation entity (see Section 6.2) receives electronic copies of submissions that are allocated for them to evaluate. The conditions of storage, management and disposal of submission material are explicitly stated in the department’s contracts.

All people undertaking evaluations or other work for the PBAC require signed deeds of confidentiality.  Employees and subcontractors of each external evaluation group agree not to disclose information provided in the submission to a ‘third party’ – that is, they will maintain confidentiality in regard to the content of submissions and other PBAC materials.

Members of PBAC and its subcommittees

All agenda material is provided to committee members in electronic form.

Members of the PBAC and its subcommittees, and any working groups appointed by the PBAC or its subcommittees, are required to sign a deed of confidentiality when appointed. The deed includes text about not disclosing information provided in the agenda papers to a ‘third party’.

Members are advised of the requirements to securely handle and dispose of confidential material appropriately, whether electronic or printed.

Other interested parties

From time to time, other parties will need to have information from submissions or PBAC agenda papers released for specific purposes. These include – but are not limited to – giving technical or expert advice, assisting with implementation or providing a consumer perspective. Examples of the people who may have access to this material are other officers within the department, such as the Therapeutic Goods Administration (TGA) and Population Health Division, and non-department employees such as clinicians or other health care professionals, members of the Australian Technical Advisory Group on Immunisation (ATAGI) and its working parties (for vaccine submissions only), employees of the National Prescribing Service, and officers from the Australian Government Services Australia.

Where these other parties are not currently Australian Government employees, they will have access to submission material after they sign a Deed of Confidentiality that includes text about not disclosing any information provided in the agenda papers to a ‘third party’. All attendees at meetings are required to dispose of any electronic and paper material appropriately.

3.1.2   Material contained in contracts and deeds

All material in contracts and deeds is managed according to the requirements set out in the contract or deed.

 

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