Dana Wortley (SA, Australian Labor Party) Share this | Hansard source

Tomorrow we will vote on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. In recent weeks I have received hundreds of letters and emails on this topic from across Australia, including my home state of South Australia. I have considered the information provided by numerous organisations who took the time to present their views; I considered the bill and the report tabled today. It is clear that this is not a bill for or against abortion. That debate has already been had in Australia: abortion is legal in all states and territories. This is a bill that deals with the decision-making process. It is about transparent and accountable practice in the evaluating, registering and listing of drugs in Australia. This bill seeks to remove responsibility for approval from the Minister for Health and Ageing and hand it to the Therapeutic Goods Administration, the TGA.

The real issue we are debating is whether a single member of parliament—the minister—or the Therapeutic Goods Administration should rule on the safety and availability of the drug RU486. It is my view that the current process of having the decision reside with the minister alone is flawed. The minister is simply required to notify parliament if approval is granted under his authority for evaluation by the TGA of a drug. This decision would not be disallowable by the parliament and therefore could not be considered parliamentary scrutiny. The minister is also not required to inform the parliament of his decision not to approve an application. This means that today parliament is not necessarily informed of these decisions; nor does it have the capacity for oversight of any decisions made by the minister.

However, it is the role of the Therapeutic Goods Administration to carry out a range of assessment and monitoring activities and to ensure the Australian public has access to therapeutic advances. The Australian Drug Evaluation Committee, established more than 40 years ago, is an expert committee of the TGA. Members of this committee are appointed by the minister and are required to have professional qualifications in numerous areas, including pharmacology, toxicology, clinical medicine or general practice. Through the TGA, the Australian Drug Evaluation Committee advises the minister for health and the Secretary of the Commonwealth Department of Health and Ageing. They examine the conditions of manufacture, the clinical impact and the safety of drugs.

Since its establishment in 1989, the TGA has monitored and assessed nearly 50,000 drugs on which Australians rely for health reasons. Supporting this bill means that the evaluation of RU486 will follow the same procedures that are used to evaluate other drugs and medical devices in Australia. The TGA is the authority charged with assessing the risk of drugs. We have no reason to doubt that the TGA would weigh the medical evidence and deliver a considered judgment about the risk and benefit profile of the drug.

Research indicates the antiprogesterone RU486 is also capable of improving and saving the lives of seriously ill Australians who for the past decade have been denied ready and affordable access to treatment for serious medical conditions including breast and prostate cancer, glaucoma, depression, endometriosis, Cushing’s syndrome, uterine fibroids and inoperable meningiomas. The current ban appears to have curtailed research into the drug’s uses. Indeed, the Secretary of the Commonwealth Department of Health and Ageing acknowledged that only a small number of cancer patients had gained access to the drug. The Special Access Scheme was designed to allow registered medical practitioners to request approval to import unapproved therapeutic goods into Australia to treat individual patients with case-by-case evaluation of applications; it has been described as stressful, time-consuming and expensive. There are often lengthy delays and some patients, despite being classified as ‘very seriously ill’ have been unable to import the drug.

The Senate is not voting to approve or reject the drug RU486; it is debating who should have the authority to make that decision—the minister or the TGA, which is the accredited Commonwealth agency established to make those decisions on other drugs. As with other drugs, RU486 will require TGA approval for importation and use. This is the case for drugs not currently approved. It is not the role of any politician to determine whether the drug RU486 is safe. That is not the intention of this bill. It is about ensuring that the proper authority—the TGA, which is made up of qualified experts—be given regulatory oversight of RU486.