3 Confidentiality and transparency
The Australian Government, and the PBAC and its subcommittees, are conscious of the need to be as open as possible in proceedings and provide as much information as possible in relation to listing medicines/vaccines on the PBS/NIP. The constraints on providing all information associated with submissions to the PBAC and other listing documents arise generally from considerations of privacy, commercial sensitivity and as a consequence of the operation of relevant Commonwealth Acts and Regulations.
A number of Acts made by parliament are relevant to the management and release of information, which form part of the procedures for listing a medicine/vaccine on the PBS/NIP. The information includes submission documents prepared by sponsors to list medicines/vaccines on the PBS/NIP, other general submissions to the PBAC, all agenda items considered by the PBAC, and other letters and applications made directly to the Australian Government Department of Health. Relevant Acts include:
- National Health Act 1953. This Act establishes the PBS. Section 135A of this Act specifically deals with the protection of information obtained for the purpose of the Act and provides for an offence for inappropriate disclosure
- Health Insurance Act 1973
- Privacy Act 1988. This Act regulates how personal information is handled, and includes Australian Privacy Principles with which all Australian Government agencies comply
- Freedom of Information Act 1982. This Act provides a legally enforceable right of access to government documents
- Copyright Act 1968
- Archive Act 1983.
Specific provisions dealing with the confidentiality of information are provided for in contracts between contractors for services and the government, and deeds of agreement between pharmaceutical companies and the government.
The Australian Government and the Government of the United States of America signed the Australia – United States Free Trade Agreement (AUSFTA) in 2004, which came into effect on 1 January 2005. There are agreed-to principles in relation to transparency and the processes that apply to both countries in managing their respective pharmaceutical programs at the federal level.
These principles are found in Annex 2-C – Pharmaceuticals of the AUSFTA. An explanation of these can be found on the Department of Health’s website about the AUSFTA.