Ms Catherine King (Ballarat, Australian Labor Party, Parliamentary Secretary for Health and Ageing) Share this | Hansard source

in reply—I rise to speak on the Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010. I thank both the member for Boothby and the member to Shortland for their contributions to this debate. As I mentioned in the second reading speech, this bill and the government’s amendments to be moved in committee will amend the Therapeutic Goods Act 1989 in the number of ways.

First of all, the bill implements arrangements to enable medical devices which are not approved by the Therapeutic Goods Administration to be temporarily supplied in Australia to substitute for approved medicines that are unavailable or are in short supply. This will mirror an existing provision under the Therapeutic Goods Act that has been operating successfully for medicines.

The bill also enables export variants of registered or listed medicines to be listed, and this amendment will support Australian businesses to compete internationally by enabling them to make minor modifications to non-active ingredients in medicines so as to meet the specific requirements of importing countries. We are committed, as a government, to implementing export variant arrangements, and the amendments follow through on that commitment to support Australian exports.

The bill also makes a number of smaller changes to the act. They include providing that information can be sought from sponsors about compliance, with conditions imposed on improved medicines, and also about whether goods are being imported, exported or supplied; providing a more efficient process for the ministerial reconsideration of initial decisions by the TGA to ensure that the minister or minister’s delegate is afforded the full 60 days in which to consider all relevant information; and clarifying the provisions that allow the minister to determine a list of ingredients permitted for use in listed medicines.

I note that the opposition has raised an issue regarding drafting. That was raised in the Senate inquiry. I do have to apologise. I am continuing to seek some advice on that. I understand the response to the Senate query on that was lodged with the selection committee but that was part of the previous bill. We are just trying to seek some further advice on that. Hopefully we will have that by the time I have finished speaking.

I would like to turn now to the government amendments to the bill, which I will be moving in committee. These amendments principally implement measures to formalise the process for submission and approval of product information for medicines. The product information document contains important technical information about a medicine. Its purpose is to assist medical practitioners, pharmacists and other health professionals in prescribing and dispensing the medicine and to assist them to provide patient education and the medicine that will support high-quality and safe clinical care. The amendments will provide for a consistent format for product information documents and ensure that approved product information cannot be changed without the approval of the secretary of the Department of Health and Ageing.

The government amendments also make changes to the act relating to the business process reforms currently being implemented in relation to the evaluation of prescription medicines. The TGA and industry have been working together in a review of the prescription medicines evaluation process, and a number of areas for process improvement have been identified to eliminate unnecessary queues and delays in the evaluation process. The new processes are to commence from 1 November 2010, and the intention is to reduce the current 500 days for a new prescription medicine to be approved to approximately 300 days. The amendments make a small number of changes to the act to support elements of this streamlined evaluation process. I have to say they are supported by industry, who have been actively engaged and involved in those new business reform processes.

The government amendments also seek to clarify the operation of section 9D of the act, under which requests for the variation of entries in the Australian Register of Therapeutic Goods can be made, and the operation of section 7 of the act, under which the secretary can declare that particular goods are therapeutic goods and therefore come within the act’s regulatory regime. Australia has been served well by the TGA in the past, and it is important that the regulatory regime it 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 also note that in the contribution from the member for Boothby he expressed, as a broader general term, some concerns about the process between Australia and New Zealand. I can assure the member for Boothby that the government is still committed to exploring those reforms. Unfortunately there has been, obviously, as he pointed out, some disagreement about how that may happen. It is a complex and difficult process. I think anyone who was involved in the harmonisation of the food standards between Australia and New Zealand and the establishment of that regulatory regime will understand that it is a very complex process, but it is something to which the government continues to work. I want to, again, thank the member for Boothby and the member for Shortland for their contributions to the bill. I will let debate continue.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

See this speech in context