Mark Butler (Port Adelaide, Australian Labor Party, Parliamentary Secretary for Health) Share this | Hansard source

I thank members for their contributions to this debate on the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009. I thank the opposition for its support for this bill and particularly recognise the member for Mallee’s cameo performance at very short notice standing in for the shadow minister for health and ageing. As mentioned in the second reading speech, this bill amends the Therapeutic Goods Act 1989 in a number of ways. Most importantly, it implements new arrangements for the separate scheduling of medicines and poisons, reflecting the recommendation from the review of the Council of Australian Governments of drugs, poisons and controlled substances legislation undertaken by Ms Rhonda Galbally in 2001 and reiterated in a Productivity Commission report published in July last year.

This bill is the third in a series of bills making improvements to and strengthening the regulation of therapeutic goods in Australia. I am pleased to advise the chamber that the Senate Community Affairs Legislation Committee has inquired into the bill and recommended in its report of 7 August this year that it be passed without delay. Since the release of the Galbally review in 2001, the Therapeutic Goods Administration has undertaken negotiations with both state and territory governments, as key partners in scheduling, as well as consultations with industry. Most recently in May, the TGA undertook consultations in relation to the details to be developed under the bill. Feedback on submissions made during this consultation, detailing the comments made and proposed amendments to the framework, has been posted on the TGA website.

However, as members will appreciate, not all of the suggestions made over the past eight years were able to be taken on board and reflected in the bill that is before the House today. This is because the arrangements need to strike a balance between the flexibility and responsiveness sought by industry with the safety and access needs of consumers. They also need to fit within the overarching Commonwealth, state and territory structures within which the arrangements exist. Nonetheless, many improvements have been achieved in the drafting of this bill as a result of comments and suggestions made during the consultations. I am also stating here today that the government’s agreement that the chairs of the first expert committees for medicines and for chemical scheduling, formed under this bill, will be independent of the Commonwealth. This suggestion was made by ASMI, the self-medication industry group, and I am pleased to agree to it. Further discussions will be had with industry to ensure that the regulations underpinning this bill will promote both transparency and accountability. This government is committed to open and cooperative consultations with industry and, as I have said, further consultations are set to occur with industry to finalise the details of the arrangements to be established under this bill. I am confident that through these consultations administrative processes for scheduling will be developed that will be responsive to industry needs while maintaining the necessary balance between safety and access to medicines and chemicals.

Another issue raised during the Senate committee’s consideration of this bill was its constitutionality. Under the Constitution responsibility for controlling the access to and supply of substances rests with the states and territories. The Therapeutic Goods Act currently empowers the Commonwealth to establish a national schedule of medicines and chemicals that can then be adopted by the states and territories as a way of achieving national consistency. The amendments in the bill simply put in place a different process for setting the national schedule. The Senate Community Affairs Legislation Committee, in considering the bill, received submissions which on the one hand included calls from industry for the Commonwealth to take over the role of the states and territories and fully nationalise scheduling, while on the other hand presenting legal advice that called into question the constitutionality of the Commonwealth’s involvement in scheduling at all. Both extremes involve a misunderstanding of the constitutional position. While there is no power for the Commonwealth to legislate to impose a comprehensive national scheme, there is no doubt about its power to legislate to establish a schedule as part of a collaborative arrangement with the states and territories.

The bill also makes a number of smaller changes to the act to improve its operation. As indicated in the second reading speech, the changes made by this bill did not encompass all of the reforms the government intends to make to the therapeutic goods regulatory regime. The amendments in this bill are the third instalment in an ongoing program of reform to the act. Australia has been served well by the TGA in the past and it is important that the regulatory regime the TGA implements is kept up to date so that the TGA and the industry it regulates can operate as efficiently as possible, so that Australian consumers can continue to have timely access to safe and effective therapeutic goods. I commend the bill to the House.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

Ordered that this bill be reported to the House without amendment.

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