• January 13, 2006. Inside U.S. Trade. U.S., Australian Drug Companies Seek Changes to Provisions in FTA.
• January 13, 2006. Op-ed by Thomas Faunce and David Henry in The Age. Drug lobby preparing a bitter pill.
• January 11, 2006. Annabel Stafford for the Financial Reveiw. PBS cost-cutting options go to cabinet.
• January 4, 2006. David Wroe for The Age. Drug price alert on trade pact.

• March 3, 2003. Australia chapter of 301 submission to USTR.
• February 20, 2001. Australia chapter of 301 submission to USTR.
• February 18, 2000, 301 Submission to USTR
• Decmeber 3, 1999, PhRMA's 2000 NTE submissions were extensive, and asked the US government to address a wide range of Australia policies on pricing of pharmaceutical drugs, as well as other issues such as health registration data exclusivity.
• February 16, 1999, 301 Submission to USTR
• December 4, 1998, PhRMA's 1999 NTE Submission

US government Documents

• USTR's 1999 NTE Report was not severe regarding Australia's policies on pharmaceuticals, focusing mostly on "unfair competition" issues for health registration data, a dispute that began over registration of generic forms of Paclitaxel.

  Only in April 1998 did Australia begin a regime to protect test data submitted to regulatory authorities for marketing approval of pharmaceuticals. This regime is a minimalist one, providing protection only for five years and only for new chemical compounds. No protection is provided for new uses and new formulations for existing compounds. Legislation to provide the same level of protection for agricultural chemicals and veterinary medicines is pending.

• This is from the USTR 1996 NTE report on Australia:

  Australia does not provide applicants for marketing approval for pharmaceuticals and agricultural chemicals a period of "marketing exclusivity" during which the data they submit with their application will not be used to review later applications. The United States maintains that the TRIPs agreement requires that such data be protected against "unfair commercial use." The United States interprets "unfair commercial use" to preclude the use of the data to review later applications for a period of time. While the Australian Government claims that it does not use data without the consent of the submitter, a report prepared for the Australian Government indicates that data will not be accepted in the first instance unless the consent is given. We have raised this issue on numerous occasions and in various fora. The Australians disagree with U.S. TRIPs interpretation. We are currently reviewing our options as to resolution of this issue.

Summary: The Australian government subsidizes the purchase of a number of drugs, which highly influences the national sales of those drugs. In order for sales of a certain drug to be subsidized, that drug must be listed on the government's Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) is the body which decides which drugs will be included in the PBS. Recently, former pharmaceutical industry lobbyist Pat Clear was appointed a member of the PBAC. The Chairman of the PBAC, Professor Don Birkitt, resigned in protest. Listed below are news stories concerning the controversy:

• July 10, 2001. Matthew Spencer and Karen Dearne for Australian IT. Lecturer charged over uni website.
• February 19, 2001. Transcript of Four Corners (Australian Broadcasting Company TV show). Paying the Price. Producer: Peter McEvoy.
• February 10, 2001. Bebe Loff and Steven Cordner in the Lancet. Australian government loosens its grip on the pharmaceutical industry.
• February 8, 2001. Darren Gray and Louise Dodson in The Age. Health Minister faces new attack over drug panel.
• February 7, 2001. Mark Metherell in the Sydney Morning Herald. Wooldridge Blames Drug Experts for "Dummy Spit."
• February 3, 2001. Julie-Anne Davies and Mellisa Marino in The Age. Drug row draws censure.
• February 3, 2001. Editorial in The Age. A cloud hangs over national drugs body.
• February 2, 2001. Mike Seccombe in the Sydney Morning Herald. Wooldridge accused as drug revolt grows.
• February 2, 2001. Julie-Anne Davies. Too many bitter pills.
• February 2, 2001. Julie-Anne Davies. Drug's listing costs taxpayers millions.
• February 2, 2001. Mellisa Marino in The Age. Drug appointment a conflict: Beazley
• February 2, 2001. The Advertiser. Drug advisory chairman quits
• February 1, 2001. Mike Seccombe in the Sydney Morning Herald. Drug body rebels as lobbyist joins ranks.
• February 1, 2001. Mark Metherell in the Sydney Morning Herald. Canberra sides with drug giants to curb own watchdog.
• February 1, 2001. Julie-Anne Davies and Melissa Marino in The Age. Drug supremo resigns in anger
• February 1, 2001. Melissa Marino in The Age. Former drug cheif may join committee.
• February 1, 2001. Ananova. Aussie drugs cheif quits in protest.

• April 28, 2002. Robyn Riley for the Sunday Herald Sun. $50,000 A Year to Stay Alive.
• October 10, 2001. Megan Nicholson for AIDS Map. Asia - Pacific conference split on standard of care.
• December 1, 2000 Government to scrap drug watchdog