Inquiry into Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005

8 February 2006

© Commonwealth of Australia 2006
ISBN  0 642 71604 8

INTRODUCTION

THE BILL

THE INQUIRY

THE APPROVAL PROCESSES

THE DRUG RU486 (MIFEPRISTONE)

• Medical terminations
• Non-abortifacient uses of mifepristone
• Misoprostol use in conjunction with mifepriston
• The definition of 'therapeutic good'
• Factually flawed claimsARGUMENTS IN SUPPORT OF THE BILL
• Abortion in Australia
• Women's Right of Choice
• Ministerial v Therapeutic Goods Administration responsibility
• The Minister for Health
• The Therapeutic Goods Administration
• The 1996 amendments to the Act and their impact
• RU486 and International evidence and approval
• Approval and use as a safe and effective drug
• Mental health issues raised by the Christchurch Health and Development Study
• Availability of RU486 should it be approved
• No evidence that abortion rates would increase
• Medical practitioners
• Rural Issues
• Queensland
• Tasmania
• Victoria
• Western Australia
• Working to reduce unwanted pregnancies

ARGUMENTS OPPOSED TO THE BILL

• Effect of the Bill broader than stated purpose
• Accountability
• RU486 is unique
• TGA assessment limitations and the moral dilemma
• Concerns at TGA research and public safety
• Minister should retain responsibility
• Responsibility should be broadened to involve cabinet and/or Parliament
• A Committee of Expert
• Abortion in Australia
• Safety of RU486
• Can be pro-choice and anti-RU486
• Complications arising from RU486 procedure
• Adverse events, associated deaths and FDA concerns
• Use and Monitoring if made available
• Psychological issues
• Impact on medical practitioners and medicine
• Use of RU486 for other medical indications
• Rural issues
• 1996 Amendments to TGA Act
• History of the ‘restricted goods’ provisions in the 1996 Amendments
• Availability of RU486 and increased abortion numbers
• Addressing issues associated with unwanted pregnancies